Tube and method for expanding and / or contracting the tube

Expandable tubing with radial and axial reinforcements and actuators addresses the challenge of accommodating medical devices or implants without kinking, ensuring structural integrity and controlled expansion.

JP2025535183APending Publication Date: 2025-10-22QMAX
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Patent Information

Application Number
JP2025523104
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-10-20
Filing Date
2023-10-20
Publication Date
2025-10-22

AI Technical Summary

Technical Problem

Existing medical devices with tubing lack effective mechanisms for expanding to accommodate other devices or implants while preventing kinking and maintaining structural integrity.

Method used

The development of expandable tubing with reinforcements that allow radial expansion while inhibiting axial expansion, using materials like radial ePTFE and axial ePTFE, and incorporating actuators to actively control expansion.

Benefits of technology

The solution provides tubing that can expand to accommodate medical devices or implants without kinking, maintaining structural integrity and allowing for controlled expansion and contraction.

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Abstract

Passively expandable and contractible tubing, dynamically expandable and contractible tubing, and non-expandable tubing and methods of using same are disclosed. Tubes having one or more layers are disclosed. Tubes having one or more reinforcements are disclosed. Tubes comprising radial and / or axial ePTFE are disclosed.
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Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Application No. 63 / 380,331, filed October 20, 2022, which is incorporated herein by reference in its entirety for all purposes.

[0002] The present disclosure relates generally to tubes, for example, passively and / or actively expandable tubes. [Background technology]

[0003] There remains a need for improved medical devices having tubing useful for applications such as access devices, catheters, introducers, or other such devices intended to provide access to regions within the body. For example, such devices can include dynamic wall structures that readily expand to allow passage of other medical devices, components, and / or implants, with the dynamic wall returning to its normal diameter after passage of the secondary medical device, component, and / or implant. Such dynamic wall structures can include active dynamic wall tubing, in which expansion of the tubing requires activation. Alternatively, such dynamic wall structures can be passive, in which the tubing expands and contracts to accommodate passage of a device through the structure. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Application No. 15 / 891,024 (U.S. Patent Application Publication No. 2018 / 0344981) Summary of the Invention [Means for solving the problem]

[0005] The present disclosure relates generally to tubes, for example, passively expandable tubes and / or actively expandable tubes.

[0006] Disclosed herein are tubes. For example, expandable tubing is disclosed that has a tube body and a reinforcement positioned on and / or within the wall of the tube body. The reinforcement and the tube body can be expandable from a neutral state to an expanded state. The reinforcement can be configured to inhibit or prevent kinking of the tube body.

[0007] Disclosed herein are tubes. For example, expandable tubing having a tube body and a reinforcement positioned on and / or within the wall of the tube body. The reinforcement and the tube body can be expandable from a neutral state to an expanded state. The reinforcement can be configured to transmit a compressive force along the length of the tube body and / or can be configured to transmit a torque along the tube body.

[0008] Disclosed is a tube, for example, an expandable tubing having a tube body portion, the tube body portion being radially expandable from a neutral state to an expanded state, such that the diameter of the tube body portion can be larger when the tube body portion is in the expanded state than when the tube body portion is in the neutral state. Axial expansion of the tube body portion can be inhibited or prevented.

[0009] Disclosed is a tube, for example, an expandable tubing having a tube body including radial ePTFE having nodes and fibrils, which can be configured to allow radial expansion of the tube body but prevent axial expansion.

[0010] Disclosed is a tube, for example, an actively expandable tubing having a tube body and an actuator positioned on and / or within a wall of the tube body. The actuator can be configured to expand axially and radially expand the tube body. Axial expansion of the tube body can be inhibited or prevented.

[0011] Disclosed is an actively expandable tubing having a tube body including radial ePTFE and an actuator including axial ePTFE. The radial ePTFE can be configured to allow radial expansion of the tube body but prevent axial expansion. The axial ePTFE can be configured to allow axial expansion of the actuator but prevent radial expansion.

[0012] Disclosed is a tube, for example, a non-expandable tubing having a tube body with a reinforcement helically wrapped around the lumen of the tube body, where kinking of the tube body can be prevented via the reinforcement.

[0013] The drawings shown and described are illustrative, illustrative, and not limiting. Like reference numbers indicate identical or functionally equivalent features throughout. [Brief explanation of the drawings]

[0014] [Figure 1A] FIG. 1 illustrates one example of an expandable tube configuration. [Figure 1B] 13A-13C illustrate the expansion of the structural elements to allow for an expandable tube when positioned within the tube body. [Figure 1C] FIG. 1 illustrates a structural element before expansion. [Figure 1D] FIG. 10 shows the structural elements after expansion. [Figure 2A] 10A-10C show another variation of the structural element before expansion but in a linear configuration. [Figure 2B] FIG. 2B shows a variation of the structural element in FIG. 2A after expansion. [Figure 2C] FIG. 10 illustrates a partial cutaway section of dynamic walled tubing with the structural elements in a non-extended or non-expanded configuration. [Figure 2D] FIG. 10 shows a partial cutaway section of dynamic walled tubing with the structural elements in an extended or expanded configuration. [Figure 3A] FIG. 10 illustrates another variation of a structural element 120 for use with dynamic walled tubing. [Figure 3B] FIG. 10 illustrates another variation of a structural element 120 for use with dynamic walled tubing. [Figure 3C] FIG. 10 illustrates another variation of a structural element 120 for use with dynamic walled tubing. [Figure 3D] FIG. 10 illustrates another variation of a structural element 120 for use with dynamic walled tubing. [Figure 3E] FIG. 10 illustrates another variation of a structural element 120 for use with dynamic walled tubing. [Figure 3F] FIG. 10 illustrates another variation of a structural element 120 for use with dynamic walled tubing. [Figure 3G] FIG. 10 illustrates another variation of a structural element 120 for use with dynamic walled tubing. [Figure 4A] FIG. 10 shows another variation of a passive dynamic walled tube. [Figure 4B] 4B is a cross-sectional view of the tube of FIG. 4A taken along line 4B-4B. [Figure 4C] 4A and 4B to illustrate the radial forces representing the passage of a device through the lumen of the dynamic walled tubing. [Figure 4D] FIG. 10 shows another variation of dynamic walled tubing with a secondary material extending in a helical configuration around the tubing. [Figure 5A] 10A-10C show another variation of a dynamic-walled tube configured with an expandable tip. [Figure 5B] FIG. 5B shows an extension mechanism for expanding the tip of the device of FIG. 5A. [Figure 5C] FIG. 1 shows a cross-sectional view of the tip of an expandable tip catheter when in an unexpanded configuration. [Figure 6A] FIG. 10 is a side view of a variation of the tube in a straight, unexpanded configuration. [Figure 6B] 6B is a side view of the tube of FIG. 6A when the tube is in a curved, unexpanded configuration. [Figure 6C] 6B is a side view of the tube of FIG. 6A when the tube is in an expanded configuration. [Figure 6D] Figure 6A and Figure 6D show side views of the tube of Figure 6B when the tube is in a curved, expanded configuration. [Figure 7A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 7A shows a tube with a reinforcement (e.g., reinforcement 308 having a nested configuration). [Figure 7B] Figure 7B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 7B shows the section of the tube in Figure 7A in an expanded configuration. [Figure 7C] 7C is a cross-sectional view of the tube of FIG. 7A taken along line 7C-7C. [Figure 7D] 7D is a cross-sectional view of the tube of FIG. 7B taken along line 7D-7D. [Figure 8A]For example, a close-up side view of the tube of Figure 6A at section S5 when the tube is in an unexpanded configuration. Figure 8A shows a tube with a reinforcement (e.g., reinforcement 308 having a separated configuration). [Figure 8B] Figure 8B is a close-up side view of the tube of Figure 6C at section S6 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 8B shows the section of the tube in Figure 8A in an expanded configuration. [Figure 8C] 8C is a cross-sectional view of the tube of FIG. 8A taken along line 8C-8C. [Figure 8D] 8D is a cross-sectional view of the tube of FIG. 8B taken along line 8D-8D. [Figure 9A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 9A shows a tube with a reinforcement (e.g., reinforcement 308 having peak-to-peak deformation). [Figure 9B] Figure 9B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 9B shows the section of the tube in Figure 9A in an expanded configuration. [Figure 9C] 9C is a cross-sectional view of the tube of FIG. 9A taken along line 9C-9C. [Figure 9D] FIG. 9D is a cross-sectional view of the tube of FIG. 9B taken along line 9D-9D. [Figure 9E] 9E is a close-up view of the compressed side of the tube of FIG. 6B at section S3. The perspective for FIG. 9E is indicated by viewing arrow V1 in FIG. 6B, such that FIG. 9E shows the radially inward curve at section S3. FIG. 9E shows that the compressed side of the tube of FIG. 6B at section S3 may be, for example, a bottom view of the tube. [Figure 9F]9F is a close-up view of the tensioned side of the tube of FIG. 6B at section S3. The perspective for FIG. 9F is indicated by viewing arrow V2 in FIG. 6B, such that FIG. 9F shows the radially outward side of the curve at section S3. FIG. 9F shows that the tensioned side of the tube of FIG. 6B at section S3 may be, for example, a top view of the tube. FIG. 9F shows that the tensioned side of the tube at section S3 may be opposite the compressed side of the tube at section S3. [Figure 9G] 9G is a close-up view of the compressed side of the tube of FIG. 6D at section S4. The perspective for FIG. 9G is indicated by viewing arrow V1 in FIG. 6D, such that FIG. 9G shows the radially inward portion of the curve at section S4. FIG. 9G shows that the compressed side of the tube of FIG. 6D at section S4 may be, for example, a bottom view of the tube. [Figure 9H] 9H is a close-up view of the tensioned side of the tube of FIG. 6D at section S4. The perspective for FIG. 9H is indicated by viewing arrow V2 in FIG. 6D, such that FIG. 9H shows the radially outward side of the curve at section S4. FIG. 9H shows that the tensioned side of the tube of FIG. 6D at section S4 may be, for example, a top view of the tube. FIG. 9H shows that the tensioned side of the tube at section S4 may be opposite the compressed side of the tube at section S4. [Figure 10A] For example, Figure 10A shows a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 10A shows a tube with a first reinforcement (e.g., reinforcement 308 having a nested configuration) and a second reinforcement (e.g., reinforcement 310). [Figure 10B] Figure 10B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 10B shows the section of the tube in Figure 10A in an expanded configuration. [Figure 10C] 10C is a cross-sectional view of the tube of FIG. 10A taken along line 10C-10C. [Figure 10D] FIG. 10D is a cross-sectional view of the tube of FIG. 10B taken along line 10D-10D. [Figure 11A] For example, Figure 11A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 11A shows a tube with a first reinforcer (e.g., reinforcer 308 having a separated configuration) and a second reinforcer (e.g., reinforcer 310). [Figure 11B] Figure 11B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 11B shows the section of the tube in Figure 11A in an expanded configuration. [Figure 11C] FIG. 11C is a cross-sectional view of the tube of FIG. 11A taken along line 11C-11C. [Figure 11D] FIG. 11D is a cross-sectional view of the tube of FIG. 11B taken along line 11D-11D. [Figure 12A] For example, Figure 12A shows a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 12A shows a tube with a first reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration) and a second reinforcement (e.g., reinforcement 310). [Figure 12B] Figure 12B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 12B shows the section of the tube in Figure 12A in an expanded configuration. [Figure 12C] 12C is a cross-sectional view of the tube of FIG. 12A taken along line 12C-12C. [Figure 12D] FIG. 12D is a cross-sectional view of the tube of FIG. 12B taken along line 12D-12D. [Figure 12E]12E is a close-up view of the compressed side of the tube of FIG. 6B at section S3. The perspective for FIG. 12E is indicated by viewing arrow V1 in FIG. 6B, such that FIG. 12E shows the radially inward curve at section S3. FIG. 12E shows that the compressed side of the tube of FIG. 6B at section S3 may be, for example, a bottom view of the tube. [Figure 12F] 12F is a close-up view of the tensioned side of the tube of FIG. 6B at section S3. The perspective for FIG. 12F is indicated by viewing arrow V2 in FIG. 6B, such that FIG. 12F shows the radially outward side of the curve at section S3. FIG. 12F shows that the tensioned side of the tube of FIG. 6B at section S3 may be, for example, a top view of the tube. FIG. 12F shows that the tensioned side of the tube at section S3 may be opposite the compressed side of the tube at section S3. [Figure 12G] 12G is a close-up view of the compressed side of the tube of FIG. 6D at section S4. The perspective for FIG. 12G is indicated by viewing arrow V1 in FIG. 6D, such that FIG. 12G shows the radially inward portion of the curve at section S4. FIG. 12G shows that the compressed side of the tube of FIG. 6D at section S4 may be, for example, a bottom view of the tube. [Figure 12H] 12H is a close-up view of the tensioned side of the tube of FIG. 6D at section S4. The perspective for FIG. 12H is indicated by viewing arrow V2 in FIG. 6D, such that FIG. 12H shows the radially outward side of the curve at section S4. FIG. 12H shows that the tensioned side of the tube of FIG. 6D at section S4 may be, for example, a top view of the tube. FIG. 12H shows that the tensioned side of the tube at section S4 may be opposite the compressed side of the tube at section S4. [Figure 13A]For example, Figure 13A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 13A shows a tube with a first reinforcement (e.g., reinforcement 308 having a nested configuration) and a second reinforcement (e.g., reinforcement 310). [Figure 13B] Figure 13B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 13B shows the section of the tube in Figure 13A in an expanded configuration. [Figure 13C] 13C is a cross-sectional view of the tube of FIG. 13A taken along line 13C-13C. [Figure 13D] FIG. 13D is a cross-sectional view of the tube of FIG. 13B taken along line 13D-13D. [Figure 14A] For example, Figure 14A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 14A shows a tube with a first reinforcer (e.g., reinforcer 308 having a separated configuration) and a second reinforcer (e.g., reinforcer 310). [Figure 14B] Figure 14B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 14B shows the section of the tube in Figure 14A in an expanded configuration. [Figure 14C] 14C is a cross-sectional view of the tube of FIG. 14A taken along line 14C-14C. [Figure 14D] FIG. 14D is a cross-sectional view of the tube of FIG. 14B taken along line 14D-14D. [Figure 15A] For example, Figure 15A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 15A shows a tube with a first reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration) and a second reinforcement (e.g., reinforcement 310). [Figure 15B]Figure 15B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 15B shows the section of the tube in Figure 15A in an expanded configuration. [Figure 15C] 15C is a cross-sectional view of the tube of FIG. 15A taken along line 15C-15C. [Figure 15D] FIG. 15D is a cross-sectional view of the tube of FIG. 15B taken along line 15D-15D. [Figure 15E] 15E is a close-up view of the compressed side of the tube of FIG. 6B at section S3. The perspective for FIG. 15E is indicated by viewing arrow V1 in FIG. 6B, such that FIG. 15E shows the radially inward curve at section S3. FIG. 15E shows that the compressed side of the tube of FIG. 6B at section S3 may be, for example, a bottom view of the tube. [Figure 15F] FIG. 15F is a close-up view of the tensioned side of the tube of FIG. 6B at section S3. The perspective for FIG. 15F is indicated by viewing arrow V2 in FIG. 6B, such that FIG. 15F shows the radially outward side of the curve at section S3. FIG. 15F shows that the tensioned side of the tube of FIG. 6B at section S3 may be, for example, a top view of the tube. FIG. 15F shows that the tensioned side of the tube at section S3 may be opposite the compressed side of the tube at section S3. [Figure 15G] Figure 15G is a close-up view of the compressed side of the tube of Figure 6D at section S4. The perspective for Figure 15G is indicated by viewing arrow V1 in Figure 6D, such that Figure 15G shows the radially inward portion of the curve at section S4. Figure 15G shows that the compressed side of the tube of Figure 6D at section S4 may be, for example, a bottom view of the tube. [Figure 15H]FIG. 15H is a close-up view of the tensioned side of the tube of FIG. 6D at section S4. The perspective for FIG. 15H is indicated by viewing arrow V2 in FIG. 6D, such that FIG. 15H shows the radially outward side of the curve at section S4. FIG. 15H shows that the tensioned side of the tube of FIG. 6D at section S4 may be, for example, a top view of the tube. FIG. 15H shows that the tensioned side of the tube at section S4 may be opposite the compressed side of the tube at section S4. [Figure 7A] For example, Figure 7A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 7A shows a tube with a first reinforcement (e.g., reinforcement 308 having a separated configuration) and a second reinforcement (e.g., reinforcement 310). [Figure 16B] Figure 16B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 16B shows the section of the tube in Figure 16A in an expanded configuration. [Figure 16C] 16C is a cross-sectional view of the tube of FIG. 16A taken along line 16C-16C. [Figure 16D] FIG. 16D is a cross-sectional view of the tube of FIG. 16B taken along line 16D-16D. [Figure 17A] For example, Figure 17A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 17A shows a tube with a first reinforcer (e.g., reinforcer 308 having a separated configuration) and a second reinforcer (e.g., reinforcer 310). [Figure 17B] Figure 17B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 17B shows the section of the tube in Figure 17A in an expanded configuration. [Figure 17C] 17C is a cross-sectional view of the tube of FIG. 17A taken along line 17C-17C. [Figure 17D] FIG. 17D is a cross-sectional view of the tube of FIG. 17B taken along line 17D-17D. [Figure 18A] For example, Figure 18A shows a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 18A shows a tube with a first reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration) and a second reinforcement (e.g., reinforcement 310). [Figure 18B] Figure 18B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 18B shows the section of the tube in Figure 18A in an expanded configuration. [Figure 18C] 18C is a cross-sectional view of the tube of FIG. 18A taken along line 18C-18C. [Figure 18D] FIG. 18D is a cross-sectional view of the tube of FIG. 18B taken along line 18D-18D. [Figure 18E] 18E is a close-up view of the compressed side of the tube of FIG. 6B at section S3. The perspective for FIG. 18E is indicated by viewing arrow V1 in FIG. 6B, such that FIG. 18E shows the radially inward curve at section S3. FIG. 18E shows that the compressed side of the tube of FIG. 6B at section S3 may be, for example, a bottom view of the tube. [Figure 18F] 18F is a close-up view of the tensioned side of the tube of FIG. 6B at section S3. The perspective for FIG. 18F is indicated by viewing arrow V2 in FIG. 6B, such that FIG. 18F shows the radially outward side of the curve at section S3. FIG. 18F shows that the tensioned side of the tube of FIG. 6B at section S3 may be, for example, a top view of the tube. FIG. 18F shows that the tensioned side of the tube at section S3 may be opposite the compressed side of the tube at section S3. [Figure 18G]Figure 18G is a close-up view of the compressed side of the tube of Figure 6D at section S4. The perspective for Figure 18G is indicated by viewing arrow V1 in Figure 6D, such that Figure 18G shows the radially inward portion of the curve at section S4. Figure 18G shows that the compressed side of the tube of Figure 6D at section S4 may be, for example, a bottom view of the tube. [Figure 18H] FIG. 18H is a close-up view of the tensioned side of the tube of FIG. 6D at section S4. The perspective for FIG. 18H is indicated by viewing arrow V2 in FIG. 6D, such that FIG. 18H shows the radially outward side of the curve at section S4. FIG. 18H shows that the tensioned side of the tube of FIG. 6D at section S4 may be, for example, a top view of the tube. FIG. 18H shows that the tensioned side of the tube at section S4 may be opposite the compressed side of the tube at section S4. [Figure 19A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 19A shows a tube with a reinforcement (e.g., reinforcement 308 having a nested configuration). [Figure 19B] Figure 19B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 19B shows the section of the tube in Figure 19A in an expanded configuration. [Figure 19C] 19C is a cross-sectional view of the tube of FIG. 19A taken along line 19C-19C. [Figure 19D] FIG. 19D is a cross-sectional view of the tube of FIG. 19B taken along line 19D-19D. [Figure 20A] For example, a close-up side view of the tube of Figure 6A at section S5 when the tube is in an unexpanded configuration. Figure 20A shows a tube with a reinforcement (e.g., reinforcement 308 having a separated configuration). [Figure 20B]Figure 20B is a close-up side view of the tube of Figure 6C at section S6 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 20B shows the section of the tube in Figure 20A in an expanded configuration. [Figure 20C] 20C is a cross-sectional view of the tube of FIG. 20A taken along line 20C-20C. [Figure 20D] 20D is a cross-sectional view of the tube of FIG. 20B taken along line 20D-20D. [Figure 21A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 21A shows a tube with a reinforcement (e.g., reinforcement 308 having peak-to-peak deformation). [Figure 21B] Figure 21B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 21B shows the section of the tube in Figure 21A in an expanded configuration. [Figure 21C] 21C is a cross-sectional view of the tube of FIG. 21A taken along line 21C-21C. [Figure 21D] 21D is a cross-sectional view of the tube of FIG. 21B taken along line 21D-21D. [Figure 21E] 21E is a close-up view of the compressed side of the tube of FIG. 6B at section S3. The perspective for FIG. 21E is indicated by viewing arrow V1 in FIG. 6B, such that FIG. 21E shows the radially inward curve at section S3. FIG. 21E illustrates that the compressed side of the tube of FIG. 6B at section S3 may be, for example, a bottom view of the tube. [Figure 21F]FIG. 21F is a close-up view of the tensioned side of the tube of FIG. 6B at section S3. The perspective for FIG. 21F is indicated by viewing arrow V2 in FIG. 6B, such that FIG. 21F shows the radially outward side of the curve at section S3. FIG. 21F shows that the tensioned side of the tube of FIG. 6B at section S3 may be, for example, a top view of the tube. FIG. 21F shows that the tensioned side of the tube at section S3 may be opposite the compressed side of the tube at section S3. [Figure 21G] Figure 21G is a close-up view of the compressed side of the tube of Figure 6D at section S4. The perspective for Figure 21G is indicated by viewing arrow V1 in Figure 6D, such that Figure 21G shows the radially inward portion of the curve at section S4. Figure 21G shows that the compressed side of the tube of Figure 6D at section S4 may be, for example, a bottom view of the tube. [Figure 21H] FIG. 21H is a close-up view of the tensioned side of the tube of FIG. 6D at section S4. The perspective for FIG. 21H is indicated by viewing arrow V2 in FIG. 6D, such that FIG. 21H shows the radially outward side of the curve at section S4. FIG. 21H shows that the tensioned side of the tube of FIG. 6D at section S4 may be, for example, a top view of the tube. FIG. 21H shows that the tensioned side of the tube at section S4 may be opposite the compressed side of the tube at section S4. [Figure 22A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 22A shows a tube with a reinforcement (e.g., reinforcement 308 having a nested configuration). [Figure 22B] Figure 22B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 22B shows the section of the tube in Figure 22A in an expanded configuration. [Figure 22C] 22C is a cross-sectional view of the tube of FIG. 22A taken along line 22C-22C. [Figure 22D] 22D is a cross-sectional view of the tube of FIG. 22B taken along line 22D-22D. [Figure 23A] For example, a close-up side view of the tube of Figure 6A at section S5 when the tube is in an unexpanded configuration. Figure 23A shows a tube with a reinforcement (e.g., reinforcement 308 having a separated configuration). [Figure 23B] Figure 23B is a close-up side view of the tube of Figure 6C at section S6 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 23B shows the section of the tube in Figure 23A in an expanded configuration. [Figure 23C] 23C is a cross-sectional view of the tube of FIG. 23A taken along line 23C-23C. [Figure 23D] 23D is a cross-sectional view of the tube of FIG. 23B taken along line 23D-23D. [Figure 24A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 24A shows a tube with a reinforcement (e.g., reinforcement 308 having peak-to-peak deformation). [Figure 24B] Figure 24B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 24B shows the section of the tube in Figure 24A in an expanded configuration. [Figure 24C] 24C is a cross-sectional view of the tube of FIG. 24A taken along line 24C-24C. [Figure 24D] 24D is a cross-sectional view of the tube of FIG. 24B taken along line 24D-24D. [Figure 24E]24E is a close-up view of the compressed side of the tube of FIG. 6B at section S3. The perspective for FIG. 24E is indicated by viewing arrow V1 in FIG. 6B, such that FIG. 24E shows the radially inward curve at section S3. FIG. 24E shows that the compressed side of the tube of FIG. 6B at section S3 may be, for example, a bottom view of the tube. [Figure 24F] 24F is a close-up view of the tensioned side of the tube of FIG. 6B at section S3. The perspective for FIG. 24F is indicated by viewing arrow V2 in FIG. 6B, such that FIG. 24F shows the radially outward side of the curve at section S3. FIG. 24F shows that the tensioned side of the tube of FIG. 6B at section S3 may be, for example, a top view of the tube. FIG. 24F shows that the tensioned side of the tube at section S3 may be opposite the compressed side of the tube at section S3. [Figure 24G] 24G is a close-up view of the compressed side of the tube of FIG. 6D at section S4. The perspective for FIG. 24G is indicated by viewing arrow V1 in FIG. 6D, such that FIG. 24G shows the radially inward portion of the curve at section S4. FIG. 24G shows that the compressed side of the tube of FIG. 6D at section S4 may be, for example, a bottom view of the tube. [Figure 24H] 24H is a close-up view of the tensioned side of the tube of FIG. 6D at section S4. The perspective for FIG. 24H is indicated by viewing arrow V2 in FIG. 6D, such that FIG. 24H shows the radially outward side of the curve at section S4. FIG. 24H shows that the tensioned side of the tube of FIG. 6D at section S4 may be, for example, a top view of the tube. FIG. 24H shows that the tensioned side of the tube at section S4 may be opposite the compressed side of the tube at section S4. [Figure 25A]For example, Figure 25A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 25A shows a tube with a first reinforcement (e.g., reinforcement 308 having a nested configuration) and a second reinforcement (e.g., reinforcement 310). [Figure 25B] Figure 25B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 25B shows the section of the tube in Figure 25A in an expanded configuration. [Figure 25C] 25C is a cross-sectional view of the tube of FIG. 25A taken along line 25C-25C. [Figure 25D] 25D is a cross-sectional view of the tube of FIG. 25B taken along line 25D-25D. [Figure 26A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 26A shows a tube with an actuator (e.g., actuator 120) and a reinforcer (e.g., reinforcer 308 having a nested configuration). [Figure 26B] Figure 26B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 26B shows the section of the tube in Figure 26A in an expanded configuration. [Figure 26C] 26C is a cross-sectional view of the tube of FIG. 26A taken along line 26C-26C. [Figure 26D] 26D is a cross-sectional view of the tube of FIG. 26B taken along line 26D-26D. [Figure 27A] For example, a close-up side view of the tube of Figure 6A at section S5 when the tube is in an unexpanded configuration. Figure 27A shows a tube with an actuator (e.g., actuator 120) and a reinforcer (e.g., reinforcer 308 having a separated configuration). [Figure 27B]Figure 27B is a close-up side view of the tube of Figure 6C at section S6 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 27B shows the section of the tube in Figure 27A in an expanded configuration. [Figure 27C] 27C is a cross-sectional view of the tube of FIG. 27A taken along line 27C-27C. [Figure 27D] 27D is a cross-sectional view of the tube of FIG. 27B taken along line 27D-27D. [Figure 28A] For example, Figure 28A shows a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 28A shows a tube with an actuator (e.g., actuator 120) and a reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration). [Figure 28B] Figure 28B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 28B shows the section of the tube in Figure 28A in an expanded configuration. [Figure 28C] 28C is a cross-sectional view of the tube of FIG. 28A taken along line 28C-28C. [Figure 28D] 28D is a cross-sectional view of the tube of FIG. 28B taken along line 28D-28D. [Figure 29A] For example, Figure 29A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 29A shows a tube with an actuator (e.g., actuator 120), a first reinforcement (e.g., reinforcement 308 having a nested configuration), and a second reinforcement (e.g., reinforcement 310). [Figure 29B] Figure 29B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 29B shows the section of the tube in Figure 29A in an expanded configuration. [Figure 29C] 29C is a cross-sectional view of the tube of FIG. 29A taken along line 29C-29C. [Figure 29D] 29D is a cross-sectional view of the tube of FIG. 29B taken along line 29D-29D. [Figure 30A] For example, Figure 30A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 30A shows a tube with an actuator (e.g., actuator 120), a first reinforcement (e.g., reinforcement 308 having a separated configuration), and a second reinforcement (e.g., reinforcement 310). [Figure 30B] Figure 30B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 30B shows the section of the tube in Figure 30A in an expanded configuration. [Figure 30C] 30C is a cross-sectional view of the tube of FIG. 30A taken along line 30C-30C. [Figure 30D] FIG. 30D is a cross-sectional view of the tube of FIG. 30B taken along line 30D-30D. [Figure 31A] For example, Figure 31A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 31A shows a tube with an actuator (e.g., actuator 120), a first reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration), and a second reinforcement (e.g., reinforcement 310). [Figure 31B] Figure 31B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 31B shows the section of the tube in Figure 31A in an expanded configuration. [Figure 31C] 31C is a cross-sectional view of the tube of FIG. 31A taken along line 31C-31C. [Figure 31D] FIG. 31D is a cross-sectional view of the tube of FIG. 31B taken along line 31D-31D. [Figure 32A]For example, Figure 32A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 32A shows a tube with an actuator (e.g., actuator 120), a first reinforcement (e.g., reinforcement 308 having a nested configuration), and a second reinforcement (e.g., reinforcement 310). [Figure 32B] Figure 32B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 32B shows the section of the tube in Figure 32A in an expanded configuration. [Figure 32C] 32C is a cross-sectional view of the tube of FIG. 32A taken along line 32C-32C. [Figure 32D] FIG. 32D is a cross-sectional view of the tube of FIG. 32B taken along line 32D-32D. [Figure 33A] For example, Figure 33A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 33A shows a tube with an actuator (e.g., actuator 120), a first reinforcer (e.g., reinforcer 308 having a separated configuration), and a second reinforcer (e.g., reinforcer 310). [Figure 33B] Figure 33B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 33B shows the section of the tube in Figure 33A in an expanded configuration. [Figure 33C] FIG. 33C is a cross-sectional view of the tube of FIG. 33A taken along line 33C-33C. [Figure 33D] FIG. 33D is a cross-sectional view of the tube of FIG. 33B taken along line 33D-33D. [Figure 34A]For example, Figure 34A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 34A shows a tube with an actuator (e.g., actuator 120), a first reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration), and a second reinforcement (e.g., reinforcement 310). [Figure 34B] Figure 34B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 34B shows the section of the tube in Figure 34A in an expanded configuration. [Figure 34C] 34C is a cross-sectional view of the tube of FIG. 34A taken along line 34C-34C. [Figure 34D] FIG. 34D is a cross-sectional view of the tube of FIG. 34B taken along line 34D-34D. [Figure 35A] For example, Figure 35A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 35A shows a tube with an actuator (e.g., actuator 120), a first reinforcement (e.g., reinforcement 308 having a nested configuration), and a second reinforcement (e.g., reinforcement 310). [Figure 35B] Figure 35B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 35B shows the section of the tube in Figure 35A in an expanded configuration. [Figure 35C] FIG. 35C is a cross-sectional view of the tube of FIG. 35A taken along line 35C-35C. [Figure 35D] FIG. 35D is a cross-sectional view of the tube of FIG. 35B taken along line 35D-35D. [Figure 36A]For example, Figure 36A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 36A shows a tube with an actuator (e.g., actuator 120), a first reinforcement (e.g., reinforcement 308 having a separated configuration), and a second reinforcement (e.g., reinforcement 310). [Figure 36B] Figure 36B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 36B shows the section of the tube in Figure 36A in an expanded configuration. [Figure 36C] FIG. 36C is a cross-sectional view of the tube of FIG. 36A taken along line 36C-36C. [Figure 36D] FIG. 36D is a cross-sectional view of the tube of FIG. 36B taken along line 36D-36D. [Figure 37A] For example, Figure 37A is a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 37A shows a tube with an actuator (e.g., actuator 120), a first reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration), and a second reinforcement (e.g., reinforcement 310). [Figure 37B] Figure 37B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 37B shows the section of the tube in Figure 37A in an expanded configuration. [Figure 37C] FIG. 37C is a cross-sectional view of the tube of FIG. 37A taken along line 37C-37C. [Figure 37D] FIG. 37D is a cross-sectional view of the tube of FIG. 37B taken along line 37D-37D. [Figure 38A] For example, Figure 38A shows a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 38A shows a tube with an actuator (e.g., actuator 120) and a reinforcer (e.g., reinforcer 308 having a nested configuration). [Figure 38B] Figure 38B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 38B shows the section of the tube in Figure 38A in an expanded configuration. [Figure 38C] FIG. 38C is a cross-sectional view of the tube of FIG. 38A taken along line 38C-38C. [Figure 38D] FIG. 38D is a cross-sectional view of the tube of FIG. 38B taken along line 38D-38D. [Figure 39A] For example, a close-up side view of the tube of Figure 6A at section S5 when the tube is in an unexpanded configuration. Figure 39A shows a tube with an actuator (e.g., actuator 120) and a reinforcer (e.g., reinforcer 308 having a separated configuration). [Figure 39B] Figure 39B is a close-up side view of the tube of Figure 6C at section S6 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 39B shows the section of the tube in Figure 39A in an expanded configuration. [Figure 39C] FIG. 39C is a cross-sectional view of the tube of FIG. 39A taken along line 39C-39C. [Figure 39D] FIG. 39D is a cross-sectional view of the tube of FIG. 39B taken along line 39D-39D. [Figure 40A] For example, Figure 40A shows a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 40A shows a tube with an actuator (e.g., actuator 120) and a reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration). [Figure 40B] Figure 40B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 40B shows the section of the tube in Figure 40A in an expanded configuration. [Figure 40C] FIG. 40C is a cross-sectional view of the tube of FIG. 40A taken along line 40C-40C. [Figure 40D] FIG. 40D is a cross-sectional view of the tube of FIG. 40B taken along line 40D-40D. [Figure 41A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 41A shows a tube with an actuator (e.g., actuator 120) and a reinforcement (e.g., reinforcement 310). [Figure 41B] Figure 41B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 41B shows the section of the tube in Figure 41A in an expanded configuration. [Figure 41C] 41C is a cross-sectional view of the tube of FIG. 41A taken along line 41C-41C. [Figure 41D] FIG. 41D is a cross-sectional view of the tube of FIG. 41B taken along line 41D-41D. [Figure 42A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 42A shows a tube with an actuator (e.g., actuator 120) and a reinforcement (e.g., reinforcement 308 having a nested configuration). [Figure 42B] Figure 42B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 42B shows the section of the tube in Figure 42A in an expanded configuration. [Figure 42C] 42C is a cross-sectional view of the tube of FIG. 42A taken along line 42C-42C. [Figure 42D] FIG. 42D is a cross-sectional view of the tube of FIG. 42B taken along line 42D-42D. [Figure 43A] For example, a close-up side view of the tube of Figure 6A at section S5 when the tube is in an unexpanded configuration. Figure 43A shows a tube with an actuator (e.g., actuator 120) and a reinforcer (e.g., reinforcer 308 having a separated configuration). [Figure 43B] Figure 43B is a close-up side view of the tube of Figure 6C at section S6 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 43B shows the section of the tube in Figure 43A in an expanded configuration. [Figure 43C] 43C is a cross-sectional view of the tube of FIG. 43A taken along line 43C-43C. [Figure 43D] FIG. 43D is a cross-sectional view of the tube of FIG. 43B taken along line 43D-43D. [Figure 44A] For example, a close-up side view of the tube of Figure 6A at section S1 when the tube is in an unexpanded configuration. Figure 44A shows a tube with an actuator (e.g., actuator 120) and a reinforcement (e.g., reinforcement 308 having a peak-to-peak configuration). [Figure 44B] Figure 44B is a close-up side view of the tube of Figure 6C at section S2 after the tube has been expanded, e.g., when the tube is in an expanded configuration. Figure 44B shows the section of the tube in Figure 44A in an expanded configuration. [Figure 44C] FIG. 44C is a cross-sectional view of the tube of FIG. 44A taken along line 44C-44C. [Figure 44D] FIG. 44D is a cross-sectional view of the tube of FIG. 44B taken along line 44D-44D. [Figure 45A] 10A-10C show variations of the actuator in an unextended configuration. [Figure 45B] FIG. 45B shows a variation of the actuator of FIG. 45A in an extended configuration. [Figure 45C] FIG. 45C is a cross-sectional view of the actuator of FIG. 45A taken along line 45C-45C. [Figure 45D] FIG. 45D is a cross-sectional view of the actuator of FIG. 45B taken along line 45D-45D. [Figure 45E] 45B shows a variation of the actuator of FIG. 45A in a helical profile and a variation of the reinforcement (eg, reinforcement 308). [Figure 45F]FIG. 45F shows a variation of the actuator and reinforcement of FIG. 45E in an expanded configuration. [Figure 46A] For example, variations of the tubes in Figures 7A-25D are shown when the tubes have an unexpanded configuration. Figure 46A shows that the tubes in Figures 7A-25D can have reinforcements (e.g., reinforcement 312). [Figure 46B] For example, variations of the tubes in Figures 7A-25D are shown when the tubes have an unexpanded configuration. Figure 46B shows that the tubes in Figures 7A-25D can have reinforcements (e.g., reinforcement 312). [Figure 46C] For example, variations of the tubes in Figures 7A-25D are shown when the tubes have an unexpanded configuration. Figure 46C shows that the tubes in Figures 7A-25D can have reinforcements (e.g., reinforcement 312). [Figure 47A] For example, variations of the tubes in Figures 26A-44D are shown when the tubes have an unexpanded configuration. Figure 47A shows that the tubes in Figures 26A-44D can have reinforcements (e.g., reinforcement 312). [Figure 47B] For example, variations of the tubes in Figures 26A-44D are shown when the tubes have an unexpanded configuration. Figure 47B shows that the tubes in Figures 26A-44D can have reinforcements (e.g., reinforcement 312). [Figure 47C] For example, variations of the tubes in Figures 26A-44D are shown when the tubes have an unexpanded configuration. Figure 47C shows that the tubes in Figures 26A-44D can have reinforcements (e.g., reinforcement 312). [Figure 48A] 46A shows a variation of the cross-sectional view of the tube of FIG. 46A taken along line 46Ax-46Ax when the tube is in an unexpanded configuration. [Figure 48B] 48B shows a variation of the cross-sectional view of FIG. 48A when the tube is in an expanded configuration. [Figure 49A] 46B shows a variation of the cross-sectional view of the tube of FIG. 46B taken along line 46Bx-46Bx when the tube is in an unexpanded configuration. [Figure 49B] 49B shows a variation of the cross-sectional view of FIG. 49A when the tube is in an expanded configuration. [Figure 50A] 46C is a cross-sectional view of the tube of FIG. 46C taken along line 46Cx-46Cx when the tube is in an unexpanded configuration. [Figure 50B] 50B shows a variation of the cross-sectional view of FIG. 50A when the tube is in an expanded configuration. [Figure 51A] 47A shows a variation of the cross-sectional view of the tube of FIG. 47A taken along line 47Ax-47Ax when the tube is in an unexpanded configuration. [Figure 51B] 51B shows a variation of the cross-sectional view of FIG. 51A when the tube is in an expanded configuration. [Figure 52A] 47B shows a variation of the cross-sectional view of the tube of FIG. 47B taken along line 47Bx-47Bx when the tube is in an unexpanded configuration. [Figure 52B] 52B shows a variation of the cross-sectional view of FIG. 52A when the tube is in an expanded configuration. [Figure 53A] 47C is a cross-sectional view of the tube of FIG. 47C taken along line 47Cx-47Cx when the tube is in an unexpanded configuration. [Figure 53B] 53B shows a variation of the cross-sectional view of FIG. 53A when the tube is in an expanded configuration. [Figure 54A] FIG. 10 is a side view of a variation of the braid. [Figure 54B] FIG. 10 is a side view of a variation of the braid. [Figure 54C] FIG. 10 is a side view of a variation of the braid. [Figure 54D] FIG. 10 is a side view of a variation of the braid. [Figure 54E] FIG. 10 is a side view of a variation of the braid. [Figure 54F] FIG. 10 is a side view of a variation of the braid. [Figure 55A1]FIG. 10 is a side view of a variation of the braid. [Figure 55A2] FIG. 55A is a cross-sectional view of the braid in FIG. 55A1. [Figure 55B1] FIG. 10 is a side view of a variation of the braid. [Figure 55B2] FIG. 55B1 is a cross-sectional view of the braid in FIG. [Figure 55C1] FIG. 10 is a side view of a variation of the braid. [Figure 55C2] FIG. 55C1 is a cross-sectional view of the braid in FIG. [Figure 55D1] FIG. 10 is a side view of a variation of the braid. [Figure 55D2] FIG. 55D1 is a cross-sectional view of the braid in FIG. [Figure 55E1] FIG. 10 is a side view of a variation of the braid. [Figure 55E2] FIG. 55E1 is a cross-sectional view of the braid. [Figure 56A] FIG. 10 is a side view of a variation of the braid. [Figure 56B] FIG. 10 is a side view of a variation of the braid. [Figure 56C] FIG. 10 is a side view of a variation of the braid. [Figure 56D] FIG. 10 is a side view of a variation of the braid. [Figure 56E] FIG. 10 is a side view of a variation of the braid. [Figure 56F] FIG. 10 is a side view of a variation of the braid. [Figure 57A1] FIG. 10 is a side view of a variation of the braid. [Figure 57A2] FIG. 57A is a cross-sectional view of the braid in FIG. 57A1. [Figure 57B1] FIG. 10 is a side view of a variation of the braid. [Figure 57B2] FIG. 57B1 is a cross-sectional view of the braid in FIG. [Figure 57C1] FIG. 10 is a side view of a variation of the braid. [Figure 57C2] FIG. 57C1 is a cross-sectional view of the braid in FIG. [Figure 57D1] FIG. 10 is a side view of a variation of the braid. [Figure 57D2] FIG. 57D1 is a cross-sectional view of the braid. [Figure 57E1] FIG. 10 is a side view of a variation of the braid. [Figure 57E2] FIG. 57E1 is a cross-sectional view of the braid. [Figure 58A] FIG. 10 is a perspective view of a modified example of the actuator. [Figure 58B] FIG. 10 is a perspective view of a modified example of the actuator. [Figure 59A] FIG. 10 is a perspective cutaway view of a modified example of the tube. [Figure 59B] FIG. 10 is a perspective cutaway view of a modified example of the tube. [Figure 59C] FIG. 10 is a perspective cutaway view of a modified example of the tube. [Figure 59D] FIG. 10 is a perspective cutaway view of a modified example of the tube. [Figure 60A] FIG. 10 is a side view of a modified example of the reinforcing body. [Figure 60B] FIG. 60B is a side view of the reinforcement of FIG. 60A in a radially expanded configuration. [Figure 60C] FIG. 10 is a side view of a modified example of the reinforcing body. [Figure 60D] FIG. 10 is a side view of a modified example of the reinforcing body. [Figure 61] FIG. 10 is a diagram showing a modified example of the tube. [Figure 62] Figure 62 is a side view of the section of the tube in Figure 8A in a fully expanded configuration. Figure 62 is a close-up side view of Figure 8B, which is in a fully expanded configuration. DETAILED DESCRIPTION OF THE INVENTION

[0015] The features in Figures 1A to 62 can be combined with each other in any combination.

[0016] The following illustrations demonstrate various embodiments and examples of devices and methods according to the present disclosure. Combinations of aspects of the various devices and methods, or combinations of the devices and methods themselves, are considered to be within the scope of the present disclosure.

[0017] 1A shows an example of an expandable tube configuration 100 having an outer tube body 102 with a wall thickness T1 and a lumen 104 with a diameter d1. The tube body 102 is fabricated from an expandable polymeric material and has a structural element 120 positioned therein. The structural element 120 functions to assist the outer tube body 102 in expanding when an oversized device (not shown) is passed through the lumen. The structural element can be embedded in the wall of the tube body 102, such as through an extrusion or molding process. Alternatively, the structural element 120 can be positioned in a channel extending through the wall of the tube body 102.

[0018] In the variation shown in FIG. 1A, the structural element 120 includes a wavy, zigzag, or oscillating shape, as shown in FIG. 1C. Here, the shape functions such that the total length 126 of the element 120 can be reduced and expanded to an increased length 130 upon actuation of the structural element 120, as shown in FIG. 1D. In certain variations, the length of each segmented section 128 constitutes the extended length 130. In additional variations, the structural element 120 can be elastically expandable along the length 126 to achieve the increased length 130. In the variation shown, the structural element 120 can include an elastic structure that can be pressurized from a baseline pressure P0 to an increased pressure P1, where the increased pressure straightens the structural element from the length 126 to the length 130. Clearly, alternative modes of length expansion are within the scope of variations of the present disclosure. For example, the structural element can include a shape memory alloy that is heat-activated or energy-activated to expand from its natural length 126 to its expanded length 130. Additionally, the structural element 120 can include any number of shaped configurations aside from zigzag, wavy, or oscillating shapes, so long as the length can be increased as desired.

[0019] 1A shows the state of the expandable tube 100 when the structural element 120 is in a natural or unextended state. The variation shown shows the inflation tube 106 connected to the structural element 122. Any number of valves and / or plugs 124 can be used at either end of the structural element 122.

[0020] An alternative variation of the device includes an inflation tube that is part of the structural element 122. In an initial condition, pressure P0 allows the structural element 122 to remain in a relaxed condition, in which the diameter of the lumen 104 remains d1. When desired, pressure is increased within the inflation tube 106 and / or the structural element 120, as represented by P1. This increase in pressure allows the structural element 120 to extend from its initial state (as shown in FIG. 1C) to its elongated or extended state (as shown in FIG. 1D). A corresponding change in the length of the structural element 120 from 126 to 130 acts on the tube body 120 to increase the diameter of the lumen 104 to D2. In certain variations, the wall thickness T1 of the tube body 102 in its native state remains the same or approximately the same as the wall thickness T2 in the expanded state. An alternative variation includes a device in which the thickness of the device changes between the expanded and unexpanded states.

[0021] 1B illustrates how the expansion of structural element 122 drives the expansion of expandable tube 102. As discussed above, this variation can be considered an actively expandable tube 100, in which stress-inducing, compressed, zigzag structural element 120 can be actuated to expand the diameter of tube body 102 to allow passage of oversized devices into the lumen. When pressurized, structural element 120 straightens, adding length to the circumference through the expanded diameter while allowing wall thickness T2 to remain the same or approximately the same as the unexpanded wall thickness T1 of unexpanded tube 100.

[0022] Additional variations of device 100 can include multiple structural elements 120 positioned within the wall of expandable tube 102. In addition, one or more structural elements 120 can be positioned within or around tube 102, if desired.

[0023] 2A-2C show another variation of a structural element 120 for use in a device 100 having dynamic-walled tubing. In this variation, as shown in FIG. 2A, the structural element 120 is linear and includes a reinforcement 132 (e.g., a coil or braid) positioned within an expandable liner 134. In its natural state, as shown by FIG. 2A, the liner 134 is at a first pressure P1, which corresponds to a first length 126. Upon pressurization to P2, the liner and coil expand to length 130. When the pressure returns to P1, the coil 132 and liner 134 return to the state shown by FIG. 2A.

[0024] FIG. 2C shows a cutaway portion of dynamic-walled tubing 100. As shown, the structural element of FIG. 2A is helically positioned within the wall of tube body 102. When the structural element is pressurized through port 106, structural element 120 expands in length (as shown in FIG. 2B), causing dynamic-walled tubing 100 to expand to the configuration shown in FIG. 2C. Again, the diameter of lumen 104 within tubing 100 can increase from d1 to d2, or any range therebetween. When the pressure within structural element 120 is reduced, dynamic-walled tubing 100 can return to the state depicted in FIG. 2C.

[0025] 3A-3G illustrate another variation of a structural element 120 for use with dynamic-walled tubing 100. FIGS. 3A and 3B illustrate a structural element including a first polymer 140 and a second polymer 142, where the first and second polymers 140, 142 have different structural properties, such as, for example, durometer, elasticity, etc. In the illustrated example, and as illustrated by alternative configurations of structural elements described herein, the structural element 120 can be configured to be pressurized, for example, by sealing one or both ends of the lumen 138 and using an inflation member 106 (shown in FIG. 3C). With such a configuration, at standard pressure P0, the structural element is in the configuration of FIG. 3B, e.g., a curved configuration, due to the different structural properties of the first and second polymers 140, 142. Pressurizing the element 120 to P1 causes the structural element to straighten, as shown in FIG. 3A. FIG. 3C shows the P0 configuration on the left and the P1 configuration on the right, where the structural element 120 goes from a shortened length L0 to an extended length L1.

[0026] As shown in Figure 3C, the second polymer 142 can be intermittent along the length of the structural element 120. In the variation shown, the second polymer 142 is positioned on opposite circumferential sides of the structural element 120. However, alternative variations, such as opposing helical windings, multiple strips along the structural element, etc., are within the scope of this disclosure. The variation shown in Figure 3C shows the second polymer 142 forming two arc-like shapes that form the completed wave structure at P0.

[0027] 3A-3C, the second polymer 142 includes elastic strips of lower modulus, where each opposing strip is aligned to overlie the concave portion of the corrugations (the inner portion of the curve). When the structural element 120 is pressurized, the strips stretch due to the anisotropic elastic modulus properties of the intermittently stripped dual-material tubing, straightening the corrugations. One end of the spirally wrapped, intermittently stripped corrugated tubing is sealed. The other end has an extension line 106 with a port for attachment to a pressure source. For medical applications, the port can be a Luer fitting, and the pressure source can be a syringe or other inflation device.

[0028] 3D shows structural element 120 as having a reinforcing element 148 connected thereto (in this variation, reinforcing element 148 is inside structural element 120). Such a configuration increases the kink resistance, hoop strength, buckling strength, crush resistance, torque transmission, burst strength, and pushability of structural element 120. Reinforcing element 148 can be metal or polymer, a single solid or multi-strand cable or fiber bundle, stainless steel or nitinol, shape-set or superelastic.

[0029] FIG. 3E shows a structural element 120 coupled to the tube body 102, where the structural element 120 is wrapped in a wave pattern and continuously wrapped in a spiral pattern around the circumference C0 of the tube body 102, such that the inner diameter of the expandable tube 100 is d0.

[0030] In an additional variation, the strip-like structural element described above can be cross-linked to prevent it from melting during the heat fusion process used to create the structure. The amount of cross-linking can be controlled in a subsequent cross-linking initiation process, such as exposure to UV energy, electron beam, gamma, X-ray, microwave, or other radiation source. The tubing resin can be compounded with a cross-linking inducer prior to the co-extrusion process used to create the dual durometer tubing. The amount or type of cross-linking initiator can be varied in the compounding step to achieve different degrees of cross-linking upon exposure to cross-linking energy.

[0031] Cross-linking of the structure is not a necessary requirement for heat fusing the wrapped tubing because the intermittent strip tubing material can be constructed with a higher melting point than the materials used in the liner and jacket of the resulting structure. The jacket material is not required to chemically bond to the intermittent strip structural elements; thus, for example, the jacket and / or liner can be constructed from polyurethane, silicone, or other elastomer, and the strip tubing can be constructed from PEBA resin, polyethylene, PET, or other thermoplastic.

[0032] FIG. 3F illustrates increasing pressure to P1 within the structural element 120 to increase the diameter of the expandable tube 100 to d1. As described herein, the resulting internal diameter d1 of the structure 100 expands as pressure is applied to the wrapped, stripped tubing, resulting in a larger pressurized circumference C1. While only one structural element 120 is shown in FIG. 3F, any number of structural elements 120 can be used along the axis of the tube 102. In certain variations, multiple structural elements can be wrapped around the tube 102. In certain variations, the outer diameter of the wrapped structural elements and the number of wrapped structural elements determine the helix angle. Additionally, a continuous structural element 120 can be wrapped along the axis of the tube 102.

[0033] FIG. 3G shows a variation of the expandable tubing 100 constructed as described herein. It shows that a structural element 120 (or multiple structural elements) is wrapped around the tube 102. The wrapped tube can then be covered with a polymer layer or liner 110 to hold the structure together. Alternatively, or in combination, the structural element 120 and the inner tubing 102 can be bonded to each other along the surfaces of contact. The tubing 100 can have a square or rectangular cross-section rather than a round cross-section as shown. There can also be a liner on the interior surface of the structure that stretches to increase in diameter when the structure is pressurized. This liner can be made from a thin, lubricious material such as PTFE or another more elastic polymer, with or without a coating applied to the inner surface. Fusing the wrapped tubing with the liner and jacket can be a thermal process, such as lamination, laser irradiation, ultrasound, electromagnetic induction, or radio frequency coupling. The fusion can be accomplished with or without the use of external processing aids, such as removable heat shrink tubing, or internal processing aids, such as a removable mandrel.

[0034] In another variation, fusing the wrapped structural element 120 around the tubing 102 and liner 110 can be achieved by a liquid dispersion process, such as immersion in a solution of a solvating polymer and allowing the solvent to evaporate. The resulting tubing structure 100 can be configured with a tapered tip for insertion into a blood vessel or for mating with a dilator or obturator, or it can have a balloon attached to the tip on the outer surface to provide retention to resist tensile loads or to provide a seal for either vacuum, pressure, or fluid or gas transfer. In addition to, or independent of, a balloon on the outer surface, a balloon can be attached to the interior surface over a portion of the length of one end of the structure to provide a seal for either vacuum, pressure, or fluid or gas transfer.

[0035] FIG. 4A shows another variation of a passive dynamic-walled tube 160. As shown, the dynamic-walled tube 160 includes a series of spring material 164, such as wire. In this variation, the spring material 164 includes nested wires wound in a zigzag fashion within the body of the tubing 160. The properties of the spring material 164 can be consistent or vary throughout the tubing. Additionally, the amplitude, wire pitch, number of turns, and other material parameters of the spring material 164 can be adjusted as needed throughout the length of the tubing 160. The dynamic tubing also includes one or more regions of secondary material 166 extending through the tubing that include structural properties different from the remainder of the tubing material 162. For example, the tubing material 162 can include HDPE / LDPE or a blend thereof. Meanwhile, the strip material 166 can include a low flexural modulus material, such as PolyBlend 45A material.

[0036] FIG. 4B shows a cross-sectional view taken along line 4B-4B of FIG. 4A. As shown, tubing material 162 and secondary material 166 can be co-extruded around or onto reinforcing spring material 164. Spring material 164 is constrained from an expanded state when it is extruded or formed into tubing material 162 and secondary material 166. Because tubing material 162 and secondary material 166 constrain spring material 164, spring material 164 reduces the force required to expand dynamic-walled tube 160 when a device is placed therethrough. In other words, as the dynamic-walled tubing expands due to the passage of a device therethrough, spring material 164 attempts to return to its expanded state, thereby reducing the force required to expand the dynamic-walled tubing and reducing the force required to advance a device through the dynamic-walled tubing. However, removing the device within the dynamic wall tubing 160 allows the tubing material 162 and secondary material 166 to re-constrain the spring material 164 and return to the natural state shown in FIG. 4A.

[0037] FIG. 4C illustrates the dynamic-walled tubing 160 of FIGS. 4A and 4B and illustrates the radial force RF representing the passage of a device through the lumen of the dynamic-walled tubing 160. The radial force RF causes stretching of the secondary material 166, which, in certain variations, is more elastic than the tubing material 162. As shown, the stretching of the secondary material 166 causes a deflection of the wall thickness of the secondary material 166 by an amount D, while the wall tubing 162 thickness remains substantially unchanged. As discussed above, the stored energy of the nested coil 164 serves to reduce the amount of radial force RF required to expand the dynamic-walled tubing 160 in the region of the secondary material 166. The stretching and deflection of the secondary material 166 also serves to reduce the surface area of ​​contact between the dynamic-walled tubing and the device being advanced therethrough, further reducing the amount of force required to advance a device through the dynamic-walled tubing 260.

[0038] 4D shows another variation of dynamic walled tubing 160. In this variation, secondary material 166 extends around tubing 160 in a helical configuration.

[0039] FIG. 5A shows another variation of a dynamic-walled tube configured with an expandable tip. As shown, the tip of tube 180 includes a first material 184, typically a lower durometer material (e.g., 40A), containing a lumen 178 extending therethrough and terminating at the tip. A second material 182, typically a higher durometer material (e.g., greater than 80A), is positioned adjacent to first material 184. A more elastic material 186 is then positioned adjacent to second material 182. To expand the tip, mechanism 202 causes elongation of first material 184. Because second material 182 is difficult to elongate, highly elastic material 186 elongates, allowing materials 184 and 182 to expand outward, expanding the tip as indicated by arrow 190.

[0040] FIG. 5B shows one example of a mechanism for expanding the expandable tip catheter shown in FIG. 5A. In this example, mechanism 202 includes thin-walled, longitudinally expandable pressure tubing. In additional variations, the tubing is not limited to longitudinal expansion, but effectively expands to induce a distal force on the tip of catheter 180 when positioned within lumen 178, resulting in expansion of the tip of catheter 180. As shown, the tubing includes a non-expandable section 205 adjacent to an expandable section 204. For example, expandable section 204 can include a convoluted fold in the wall of the tubing such that the length of expandable section 204 increases from L1 to L2 when tubing 202 is pressurized from P1 to P2. In one variation, the non-expandable section 206 of the tubing 202 is anchored within the lumen 178 in the first material 184 such that stretching of the expandable section 204 causes outward movement of the tip.

[0041] 6A-62 illustrate various tubes (e.g., tube 100 and tube 160) having various combinations and arrangements of various layers, materials, coatings, and / or reinforcements. The features illustrated in FIGS. 6A-62 can be combined in any combination with each other and with the features illustrated in FIGS. 1A-5C. For example, a tube (e.g., tube 100, tube 160) can have any combination of the features illustrated in FIGS. 6A-62. As another example, a tube (e.g., tube 100, tube 160) can have any combination of the features illustrated in FIGS. 1A-62.

[0042] layer Tube 160 can have one or more layers (e.g., 1, 2, 3, 4, 5, 6, or 7 or more layers, e.g., 7-12 layers, including increments of 1 layer within this range). FIGS. 6A-25D illustrate that tube 160 can have various layers, e.g., layer 302, layer 304, layer 306, or any combination thereof, in the arrangement shown. Layer 302 can be the first, second, and / or third layer. Layer 304 can be the first, second, and / or third layer. Layer 306 can be the first, second, and / or third layer. Layer 302 can be the innermost, middle, or outermost layer. Layer 304 can be the innermost, middle, or outermost layer. Layer 306 can be the innermost layer, the middle layer, or the outermost layer. For example, Figures 6A-25D show that tube 160 can have layers in the arrangement shown.

[0043] For example, with respect to tube 160 including three layers, tube 160 can have any combination of the three layers, including, for example, (1) layer 302, layer 304, and layer 306, (2) two layers 302 and layer 304, (3) two layers 302 and layer 306, (4) two layers 304 and layer 302, (5) two layers 304 and layer 306, (6) two layers 306 and layer 302, (7) two layers 306 and layer 304, (8) three layers 302, (9) three layers 304, (10) three layers 306, or any other combination of three layers. Any one of these layers can be a first layer, any one of these layers can be a second layer, and any one of these layers can be a third layer. Any one of these layers can be an inner layer, any one of these layers can be a middle layer, and any one of these layers can be an outer layer. For example, for tube 160 including layers 302, 304, and 306, layer 302 can be a first layer (e.g., an innermost layer or an outermost layer), layer 304 can be a second layer (e.g., a middle layer), and layer 306 can be a third layer (e.g., an outermost layer or an innermost layer). For example, Figures 6A-15H show that tube 160 can include more than two layers (e.g., three layers) in the arrangement shown.

[0044] As another example, with respect to a tube including two layers, tube 160 can have any combination of two layers, including, for example, (1) layers 302 and 304, (2) layers 304 and 306, (3) layers 302 and 306, (4) two layers 302, (5) two layers 304, (6) two layers 306, or any other combination of two layers. Any one of these layers can be a first layer, any one of these layers can be a second layer, and any one of these layers can be a third layer. Any one of these layers can be an inner layer, any one of these layers can be a middle layer, and any one of these layers can be an outer layer. For example, for tube 160 including layer 302 and layer 304, layer 302 can be the first layer (e.g., the innermost layer) and layer 304 can be the second layer (e.g., the outermost layer). For example, for tube 160 including layer 304 and layer 306, layer 304 can be the first layer (e.g., the innermost layer) and layer 306 can be the second layer (e.g., the outermost layer). For example, for tube 160 including layer 302 and layer 306, layer 302 can be the first layer (e.g., the innermost layer) and layer 306 can be the second layer (e.g., the outermost layer). For example, FIGS. 16A-21H show that tube 160 can include two or more layers (e.g., two layers) in the arrangement shown.

[0045] As yet another example, with respect to a tube including one layer, tube 160 can have any layer, including, for example, (1) layer 302, (2) layer 304, or (3) layer 306. For example, Figures 22A-25D illustrate that tube 160 can include one or more layers (e.g., one layer) in the arrangement shown.

[0046] 6A-25D illustrate that, for example, with respect to tube 160 with one, two, or more layers (e.g., three or more layers), tube 160 can have, for example, layer 302, layer 304, layer 306, or any combination thereof. For example, FIGS. 22A-25D illustrate that tube 160 can have one layer (e.g., layer 302), FIGS. 16A-21H illustrate that tube 160 can have two layers (e.g., layers 302 and 304), and FIGS. 6A-15H illustrate that tube 160 can have three layers (e.g., layers 302, 304, and 306). The layers can be tubes. The layers can be, for example, cylindrically shaped tubes or any other shaped tubes. The layers can be concentric with one another. For example, the layers can be concentric tubes.

[0047] The tube 160 can have a liner and / or a jacket. For example, for a tube 160 having multiple layers, the innermost layer can be a liner, and one or more outer layers can form a jacket (e.g., an elastomeric jacket). For example, for a tube 160 having two layers, the liner can include layer 302, and the jacket can include layer 304 or layer 306. As another example, for a tube 160 having three layers, the liner can include layer 302, and the jacket can include layers 304 and 306. The liner can be thinner than the jacket, or vice versa. The liner can be closer to the center of the lumen 104 than the elastomeric jacket. For example, the liner (or a coating on the liner) can form the inner surface of the tubing 160, and the jacket (or a coating on the jacket) can form the outer surface of the tubing 160. For example, FIGS. 7A-15H show that the liner can include layer 302, and the jacket can include layers 304 and 306. As another example, FIGS. 16A-21H show that the liner can include layer 302, and the jacket can include layer 304. The function of the liner and jacket can depend on the layers, materials, coatings, and / or reinforcements that tube 160 has. The wall of tube 160 can include one or more layers. Tube 160 can have a wall (e.g., a circumferential wall), whereby the wall can include one or more layers (e.g., layer 302, layer 304, and / or layer 306). As another example, the liner can be a coating applied to the innermost layer, and / or the jacket can be a coating applied to the outermost layer.

[0048] material Tube 160 can be made from one or more materials (e.g., one material, two materials, three materials, four materials, five materials, or more than five materials, e.g., 6-12 materials, including increments of one material within this range). FIGS. 6A-25D illustrate, for example, that the layers of tube 160 (e.g., layer 302, layer 304, and / or layer 306) can include various combinations of polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), a fluoroelastomer, a composite of fluoroelastomer and ePTFE (e.g., FLUOROSLIX), or any combination thereof. Other materials are also recognized, including, for example, any combination of materials disclosed or contemplated herein. As further described below, ePTFE can be, for example, ePTFE, axial ePTFE, radial ePTFE, or a hybrid ePTFE including axial ePTFE and radial ePTFE. Composite materials of fluoroelastomers and ePTFE are further described, for example, in U.S. Patent Application No. 15 / 891,024, filed February 7, 2018 (U.S. Patent Application Publication No. 2018 / 0344981), which is incorporated by reference herein in its entirety for all purposes. Any layer of tube 160 (e.g., layer 302, layer 304, and / or layer 306) can be made from any material disclosed herein, including, for example, the composite materials of fluoroelastomers and ePTFE disclosed in U.S. Patent Application No. 15 / 891,024.

[0049] Generally, ePTFE is PTFE that has been expanded during a sintering or crystallization formation phase. Typically, ePTFE is made by mechanically stretching an extruded profile of PTFE in a single or two axial directions, whereby the mechanical expansion is followed by amorphous locking (also referred to as sintering) of the axially expanded structure. For example, if the extruded PTFE profile is an extruded tube (e.g., a tube such as layer 302, layer 304, and / or layer 306), the extruded tube can be axially stretched in a single or two axial directions, for example, from a first length L1 to a second length L2, to produce an axial ePTFE tube (e.g., to produce layer 302, layer 304, and / or layer 306). By fibrillating the PTFE axially during sintering, the tube 160 can have reversible length change properties, which can reduce the force required to axially expand or lengthen the tube 160. Stretching PTFE axially (e.g., in a longitudinal direction parallel to the longitudinal axis of the extruded PTFE profile, i.e., perpendicular to the radial axis of the extruded PTFE profile) results in ePTFE that can elongate axially when the ePTFE is subjected to an axial tensile load and compress axially when the ePTFE is subjected to an axial compressive load by generating microscopic fibrils that are spaced like tiny tendons that can be sagged or tensioned in response to the application of macroscopic forces to the material. In this application, such ePTFE that has been axially stretched during formation is referred to as axial ePTFE.

[0050] The present application discloses new types of ePTFE for use with tubing (e.g., tubing 100 and 160) to provide benefits distinct from axial ePTFE. The new types of ePTFE can be made, for example, by mechanically stretching an extruded profile of PTFE in the radial direction (e.g., instead of or in addition to the axial direction), whereby the mechanical expansion is followed by amorphous locking (also referred to as sintering) of the radially expanded structure. For example, if the extruded PTFE profile is an extruded tube (e.g., a tube such as layer 302, layer 304, and / or layer 306), the extruded tube can be radially stretched (e.g., in one, two, three, four, or more radial directions, including all radial directions) away from a central longitudinal axis of the extruded tube (e.g., via an expandable and / or stretchable mandrel) from a first radius R1 to a second radius R2 to produce a radial ePTFE tube (e.g., to produce layer 302, layer 304, and / or layer 306). By fibrillating the PTFE radially during sintering, tube 160 can have reversible diameter change properties, which can reduce the force required to expand tube 160, which can reduce the force required to advance a device through lumen 104 of tube 160, and which can reduce the risk of a device (e.g., device 329) tearing or rupturing one or more layers of tube 160 as the device is advanced through lumen 104.Stretching PTFE radially (e.g., in a radial or transverse direction perpendicular to the longitudinal axis of the extruded PTFE profile, i.e., in a direction parallel to the radial direction of the extruded PTFE profile) can result in, for example, ePTFE that can expand radially when it is subjected to an outward radial load, and that can compress radially when it is subjected to a compressive radial load, by generating microscopic fibrils that are spaced like tiny tendons that can be sagged or tensioned in response to macroscopic forces applied to the material. In this application, such ePTFE that has been radially stretched during formation is referred to as radial ePTFE.

[0051] The microscopic fibrils of an axial ePTFE profile (e.g., a layer and / or tube made from axial ePTFE) and the microscopic fibrils of a radial ePTFE profile (e.g., a layer and / or tube made from radial ePTFE) having the same shape and dimensions as the axial ePTFE profile have different orientations relative to the longitudinal axis of their respective profiles, which provide different benefits. For an axial ePTFE profile, the microscopic fibrils are aligned along the longitudinal axis of the axial ePTFE profile (e.g., along the longitudinal axis of a tube made from axial ePTFE). In contrast, for a radial ePTFE profile, the microscopic fibrils are aligned perpendicular to the longitudinal axis of the radial ePTFE profile (e.g., perpendicular to the longitudinal axis of a tube made from radial ePTFE). Tube 160 (e.g., layer 302, layer 304, and / or layer 306) can include, for example, ePTFE (e.g., not axial ePTFE, not radial ePTFE), axial ePTFE, radial ePTFE, a hybrid combination of axial and radial ePTFE (e.g., ePTFE stretched in both the axial and radial directions), or any combination thereof.

[0052] Tube 160 can have axial ePTFE and / or radial ePTFE, depending on the expansion and / or compression characteristics desired for tube 160. In other words, the difference between the fibril orientation of axial ePTFE and the fibril orientation of radial ePTFE can be used to impart different expansion and / or compression characteristics to tube 160. For example, axial ePTFE can allow axial expansion and contraction and can constrain radial expansion of tube 160, while radial ePTFE can allow radial expansion and constrain axial expansion and contraction of tube 160. Compared to axial ePTFE, radial ePTFE can reduce the radial force required to radially expand tube 160, which can reduce the force required to advance a device through lumen 104 of tube 160. Thereby, the force required to radially expand radial ePTFE can be less than the force required to radially expand axial ePTFE by the same amount. As another example, radial ePTFE can reduce or prevent wrinkles and / or folds from forming when tube 160 radially contracts from a radially expanded state (e.g., from an expanded state to an unexpanded state, e.g., from diameter d2 to diameter d1), e.g., when the device is withdrawn from lumen 104. For example, compared to axial ePTFE, radial ePTFE can reduce wrinkles and / or folds from forming when tube 160 radially contracts from a radially expanded state (e.g., from diameter d2 to diameter d1). As another example, compared to axial ePTFE, radial ePTFE can reduce the size and / or number of wrinkles and / or folds that form when tube 160 radially contracts from a radially expanded state (e.g., from diameter d2 to diameter d1).As yet another example, compared to axial ePTFE, radial ePTFE may be less likely to form wrinkles and / or folds and / or may reduce the size and / or number of wrinkles and / or folds that form when tube 160 contracts radially from a radially expanded state (e.g., from diameter d2 to diameter d1). As another example, axial ePTFE may behave like PTFE in the radial direction but not in the axial direction (e.g., axial ePTFE may be more flexible than PTFE in the axial direction), while radial ePTFE may behave like PTFE in the axial direction but not in the radial direction (e.g., radial ePTFE may be more flexible than PTFE in the radial direction).

[0053] The axial ePTFE can allow axial expansion of the tube 160. For example, the axial ePTFE can allow axial expansion of the tube 160 up to an axial expansion limit, and then inhibit or prevent further axial expansion of the tube 160 once the axial expansion limit is reached. The axial expansion limit for the axial ePTFE can be, for example, a 5% to 200% increase in the length of the tube 160 (e.g., length 160L or any portion thereof), including 1% increments (e.g., 5%, 50%, 100%, 200%) within this range from the first length to the second length. The first length can be, for example, the unexpanded or neutral length of the tube 160. The second length can be, for example, the expanded length of the tube 160. For example, for a tube 160 expandable from a first length to a second length, if the first length is 10 cm and the axial expansion limit of the axial ePTFE is 100%, when the second length of the tube 160 reaches 20 cm, the axial ePTFE (e.g., the fibrils of the axial ePTFE) can be fully axially stretched (e.g., fully tensioned) such that the axial ePTFE can inhibit or prevent further axial expansion of the tube 160. In other words, when the slack present in the microscopic fibrils when the tube 160 is in an unexpanded state (e.g., when the tube 160 has a first length) is fully removed (e.g., when the tube 160 has a second length), the fibrils aligned along the longitudinal axis of the tube 160 can resist further axial expansion of the tube 160 due to the axial ePTFE fibrils being in full tension. Once the axial expansion limit is reached, the axial ePTFE can thereby inhibit or prevent further axial expansion of the axially stretched portion of the tube 160 .For example, axial ePTFE can allow axial expansion of tube 160 when tube 160 expands axially (e.g., from a first length to a second length) as a device (e.g., device 329) is advanced along lumen 104, but can limit the amount that tube 160 can expand axially up to an axial expansion limit. The axial ePTFE can inhibit or prevent axial expansion of tube 160 beyond the axial expansion limit. Allowing but limiting such axial expansion can reduce the risk of axially over-expanding tube 160, reduce the risk that layers 302, 304, and / or 306 will be torn or punctured by a device (e.g., device 329) as it is advanced axially through lumen 104, or both.

[0054] The axial ePTFE can inhibit and / or prevent radial expansion of the tube 160. For example, the axial ePTFE can prevent radial expansion of the tube 160. As another example, the axial ePTFE can allow radial expansion of the tube 160 up to a radial expansion limit, and then inhibit or prevent further radial expansion of the tube 160 once the radial expansion limit is reached. The radial expansion limit for the axial ePTFE can be, for example, a 0% to 4% increase in the diameter (e.g., inner diameter) of the tube 160, or more narrowly, a 0% to 2% increase in the diameter (e.g., inner diameter) of the tube 160, including 1% increments (e.g., 0%, 1%, 2%, 4%) within these ranges from a first diameter (e.g., diameter d1) to a second diameter (e.g., diameter d2). The first diameter d1 can be, for example, the unexpanded or neutral diameter of the tube 160. The second diameter d2 can be, for example, the expanded diameter of the tube 160. For example, for a tube 160 expandable from a first diameter (e.g., diameter d1) to a second diameter (e.g., diameter d2), if the first diameter (e.g., diameter d1) is 10.0 mm and the radial expansion limit of the axial ePTFE is 1%, then when the second diameter (e.g., diameter d2) of the tube 160 reaches 10.1 mm, the axial ePTFE can be fully radially stretched, such that the axial ePTFE can inhibit or prevent further radial expansion of the tube 160. Once the radial expansion limit is reached, the axial ePTFE can inhibit or prevent further radial expansion of the radially stretched portion of the tube 160.For example, axial ePTFE can allow a small amount of radial expansion (e.g., up to a radial expansion limit) of tube 160 when tube 160 expands axially (e.g., from a first length to a second length) as a device is advanced along lumen 104, but can limit the amount that tube 160 can radially expand up to the radial expansion limit. Allowing but limiting such radial expansion via axial ePTFE can reduce the risk that layer 302, layer 304, and / or layer 306 will be torn or punctured by a device (e.g., device 329) as the device is advanced axially through lumen 104.

[0055] The radial ePTFE can allow radial expansion of the tube 160. For example, the radial ePTFE can allow radial expansion of the tube 160 up to a radial expansion limit, and then inhibit or prevent further radial expansion of the tube 160 once the radial expansion limit is reached. The radial expansion limit for the radial ePTFE can be, for example, a 5% to 200% increase in diameter (e.g., inner diameter) of the tube 160, including 1% increments (e.g., 5%, 50%, 100%, 200%) within this range from a first diameter (e.g., diameter d1) to a second diameter (e.g., diameter d2). The first diameter d1 can be, for example, the unexpanded or neutral diameter of the tube 160. The second diameter d2 can be, for example, the expanded diameter of the tube 160. For example, for a tube 160 that is expandable from a first diameter (e.g., diameter d1) to a second diameter (e.g., diameter d2), if the first diameter (e.g., diameter d1) is 2 mm and the radial expansion limit of the radial ePTFE is 100%, when the second diameter (e.g., diameter d2) of the tube 160 reaches 4 mm, the radial ePTFE (e.g., the fibrils of the radial ePTFE) can be fully radially stretched (e.g., fully tensioned) such that the radial ePTFE can inhibit or prevent further radial expansion of the tube 160. In other words, when the slack present in the microscopic fibrils when tube 160 is in an unexpanded state (e.g., when tube 160 has a diameter d1) is completely removed (e.g., when tube 160 has a diameter d2), the fibrils aligned perpendicular to the longitudinal axis of tube 160 can resist further radial expansion of tube 160 due to the radial ePTFE fibrils being in full tension. Once the radial expansion limit is reached, the radial ePTFE can thereby inhibit or prevent further radial expansion of the radially stretched portion of tube 160.For example, radial ePTFE can allow radial expansion of tube 160 when tube 160 radially expands (e.g., from diameter d1 to diameter d2) as a device (e.g., device 329) is advanced along lumen 104, but can limit the amount that tube 160 can radially expand up to its radial expansion limit. Radial ePTFE can inhibit or prevent radial expansion of tube 160 beyond its radial expansion limit.

[0056] Allowing but limiting such radial expansion can reduce the risk of radially over-expanding tube 160, can reduce the risk of layers 302, 304, and / or 306 being torn or punctured by a device (e.g., device 329) as the device is advanced axially through lumen 104, or can both. Limiting radial expansion can be important when tube 160 is inserted into a blood vessel, for example, to limit the outward radial force exerted against the vessel as tube 160 is radially expanded. For example, limiting the radial expansion of tube 160 to a radial expansion limit can help prevent tube 160 from tearing or rupturing a blood vessel as a device (e.g., device 329) is advanced along lumen 104. The radial expansion limit can be selected, for example, based on the blood vessel or blood vessels through which tube 160 will be navigated. For example, the radial expansion limit can be equal to or less than the maximum dilated diameter of the blood vessel in which tube 160 will be placed. The radial expansion limit can be constant along the length of tube 160, or it can vary along the length of the tube.

[0057] The radial ePTFE can inhibit and / or prevent axial expansion of tube 160. For example, the radial ePTFE can prevent axial expansion of tube 160. As another example, the radial ePTFE can allow axial expansion of tube 160 up to an axial expansion limit, and then inhibit or prevent further axial expansion of tube 160 once the axial expansion limit is reached. The axial expansion limit for the radial ePTFE can be, for example, a 0% to 4% increase in the length of tube 160 (e.g., length 160L or any portion thereof), or more narrowly, a 0% to 2% increase in the length of tube 160 (e.g., length 160L or any portion thereof), including 1% increments (e.g., 0%, 1%, 2%, 4%) within these ranges from the first length to the second length. The first length can be, for example, the unexpanded or neutral length of tube 160. The second length can be, for example, the expanded length of tube 160. For example, for tube 160 expandable from a first length to a second length, if the first length is 10.0 cm and the axial expansion limit of the radial ePTFE is 1%, then when the second length of tube 160 reaches 10.1 cm, the radial ePTFE can be fully axially stretched (e.g., fully tensioned) such that the radial ePTFE can restrain or prevent further axial expansion of tube 160. Once the axial expansion limit is reached, the radial ePTFE can restrain or prevent further axial expansion of the axially stretched portion of tube 160. For example, radial ePTFE can allow a small amount of axial expansion of tube 160 (e.g., up to an axial expansion limit) when tube 160 expands radially (e.g., from diameter d1 to diameter d2) as the device is advanced along lumen 104, but can limit the amount that tube 160 can expand axially up to its axial expansion limit.Allowing but limiting such axial expansion through the radial ePTFE can reduce the risk of layers 302, 304, and / or 306 being torn or punctured by a device (e.g., device 329) as the device is advanced axially through lumen 104.

[0058] Compared to a tube 160 made from axial ePTFE having the same shape and dimensions as the tube 160 made from radial ePTFE (e.g., for this comparison, the percentage of axial ePTFE in the tube 160 made from axial ePTFE is the same as the percentage of radial ePTFE in the tube made from radial ePTFE), the radial ePTFE may allow less axial expansion of the tube 160 than the axial ePTFE. For example, the axial expansion limit for the axial ePTFE may be greater than the axial expansion limit for the radial ePTFE. For example, the axial expansion limit for the axial ePTFE may be 5% to 200%, and the axial expansion limit for the radial ePTFE may be 0% to 4%, or more narrowly, 0% to 2% (e.g., where 0% may indicate that the radial ePTFE is not extensible in the axial direction). As a result, the tube 160 with axial ePTFE may require less force (e.g., less than 0.10 N to 5.00 N) to expand axially than the tube 160 with radial ePTFE.

[0059] Compared to a tube 160 made from axial ePTFE having the same shape and dimensions as a tube 160 made from radial ePTFE (e.g., for this comparison, the percentage of axial ePTFE in the tube 160 made from axial ePTFE is the same as the percentage of radial ePTFE in the tube made from radial ePTFE), the axial ePTFE may allow less radial expansion of the tube 160 than the radial ePTFE. For example, the radial expansion limit for the radial ePTFE may be greater than the radial expansion limit for the axial ePTFE. For example, the radial expansion limit for the radial ePTFE may be 5% to 200%, and the radial expansion limit for the axial ePTFE may be 0% to 4%, or more narrowly, 0% to 2% (e.g., where 0% may indicate that the radial ePTFE is not extensible in the axial direction). As a result, the tube 160 with radial ePTFE may require less force (e.g., less than 0.10 N to 5.00 N) to radially expand than the tube 160 with axial ePTFE.

[0060] These properties of axial and / or radial ePTFE can be incorporated into tube 160 by forming one or more of the layers of tube 160 from axial ePTFE, or by forming one or more of the layers of tube 160 from radial ePTFE, or by having both of these materials in tube 160, for example, in the same layer or in two different layers.

[0061] PTFE, ePTFE, fluoroelastomers, and composites of fluoroelastomers and ePTFE have different material properties that may be beneficial in various combinations in tube 160. In this patent application, ePTFE without the prefix "axial" or "radial" can be, for example, ePTFE (e.g., not axial ePTFE, not radial ePTFE). In this patent application, ePTFE without the prefix "axial" or "radial" can be axial ePTFE and / or radial ePTFE, for example, only axial ePTFE, only radial ePTFE, or both axial and radial ePTFE. For ePTFE having both axial and radial ePTFE, the ePTFE can be programmed with a percentage of stretch in the axial and radial directions during sintering, as described above for axial and radial ePTFE. For example, ePTFE, including axial ePTFE and radial ePTFE, can have an axial programmed stretch of 1% to 100% and a radial programmed stretch of 1% to 100%, including 1% increments within each of these ranges (e.g., 50% axial and 50% radial programmed stretch, 25% axial and 75% radial programmed stretch, 75% axial and 25% radial programmed stretch, 75% axial and 100% radial programmed stretch, 25% axial and 100% radial programmed stretch).

[0062] PTFE can be a hard (e.g., harder than ePTFE), low-friction, and high-tensile strength material with a low flexural modulus in the axial and radial directions of tube 160. PTFE can be harder than ePTFE and can have higher puncture and tear resistance than ePTFE. PTFE can have a hardness of, for example, 50-67 Shore D, and ePTFE can have a hardness of, for example, 27 Shore D. The PTFE in tube 160 can thereby inhibit or prevent expansion of tube 160 in the axial and radial directions.

[0063] Fluoroelastomers can have a high flexural modulus, such that they can be stretchable and can have a higher coefficient of friction than PTFE and ePTFE. Fluoroelastomers can be fused to lower friction materials such as PTFE and ePTFE.

[0064] ePTFE can be a soft (e.g., softer than PTFE), low-friction, and high-tensile strength material with a high flexural modulus in the axial direction (e.g., axial ePTFE) and / or radial direction (e.g., radial ePTFE) of tube 160. For example, axial ePTFE can have a higher flexural modulus in the axial direction than radial ePTFE, and radial ePTFE can have a higher flexural modulus in the radial direction than axial ePTFE. ePTFE can be softer than PTFE. ePTFE can require less force to expand than PTFE. As another example, PTFE may not be expandable in the axial or radial directions. The axial ePTFE in tube 160 can facilitate expansion of tube 160 in the axial direction but inhibit or prevent expansion of tube 160 in the radial direction. For example, axial ePTFE can act as ePTFE in the axial direction and as PTFE in the radial direction. In contrast, radial ePTFE within tube 160 can promote expansion of tube 160 in the radial direction but inhibit or prevent expansion of tube 160 in the axial direction. For example, radial ePTFE can act as ePTFE in the radial direction and as PTFE in the axial direction.

[0065] The functionality of different layers (e.g., liner and jacket) can depend, for example, on the materials of layers 302, 304, and 306. As the figures in this patent application show, layers having a variety of materials can be combined with one another to form tube 160, forming tube 160 with a myriad of complementary properties.

[0066] coating Tube 160 can have an inner coating, an outer coating, an inner coating and an outer coating, or no inner or outer coating. The inner coating can be applied, for example, to the inner surface of the innermost layer. For example, the inner coating can be applied to the inner surface of layer 302, layer 304, or layer 306. The inner coating can be a hydrophilic coating, for example, Biocoat's Hydak T-70 hydrophilic coating formulation, or the like. The outer coating can be applied, for example, to the outer surface of the outermost layer. For example, the outer coating can be applied to the outer surface of layer 302, layer 304, or layer 306. The outer coating can be a hydrophilic coating, for example, Biocoat's Hydak T-70 hydrophilic coating formulation, or the like. The outer coating can reduce friction between the inner wall of a blood vessel (e.g., artery, vein) during insertion and can inhibit or prevent tube 160 from sticking to the blood vessel (e.g., artery, vein) during removal, for example. The inner and / or outer surfaces of the tube 160 can be treated with plasma to enhance the surface energy for bonding to the hydrophilic coating.

[0067] Reinforcement Tube 160 can have zero, one, or multiple reinforcements (e.g., 0 reinforcements, 1 reinforcement, 2 reinforcements, 3 reinforcements, 4 reinforcements, 5 reinforcements, or more than five reinforcements, e.g., 6-10 reinforcements, including increments of one reinforcement within this range). As shown, tube 160 can have, for example, reinforcement 308, reinforcement 310, reinforcement 312, or any combination thereof.

[0068] The reinforcement 308 can have a zigzag, wavy, or other vibrated or undulating shape. The reinforcement 308 can be, for example, a wire (e.g., a metal such as Nitinol, stainless steel, titanium, or Elgiloy), a monofilament (e.g., PEEK, PAEK, PEKK, PET, nylon, PTFE, TFE, polysulfone, Ultem), a multifilament (e.g., Spectra, Dyneema, PET, Kevlar, carbon fiber, fiberglass), or any combination thereof. The reinforcement 308 can, for example, zigzag, undulate, or vibrate circumferentially around the tube 160. The reinforcement 308 can, for example, have a zigzag, undulating, or vibrated shape. The reinforcement 308 can, for example, be round (e.g., a round wire). The reinforcement 308 can, for example, be flat (e.g., a flat wire). A flat reinforcement 308 can provide a lower tubing profile, while a round reinforcement 308 can provide a higher tensile strength. The reinforcement 308 can be embedded within a layer of the tube 160 (e.g., within layer 302, within layer 304, and / or within layer 306), can be between two layers of the tube 160 (e.g., between layer 302 and layer 304, and / or between layer 304 and layer 306), can extend along the innermost surface of the tube 160, can extend along the outermost surface of the tube 160, or any combination thereof. For example, the reinforcement 308 can be nested (e.g., embedded) within the wall of the tube 160 (e.g., within one or more layers of the tube 160). The reinforcement 308 can be wrapped in a zigzag, wave-like (e.g., sine, square, triangular, or sawtooth) or undulating fashion within one or more layers of the tube 160. As another example, the reinforcement 308 can overlie a layer of the tube 160.The reinforcement body 308 can extend around the lumen 104 of the tube 160. For example, the reinforcement body 308 can extend helically around the lumen 104 of the tube 160. The reinforcement body 308 can extend helically around the lumen 104 for, for example, one turn or multiple turns, e.g., 1 to 1000 turns, including one turn increments within this range (e.g., 1 turn, 10 turns, 50 turns, 100 turns, 200 turns).

[0069] The reinforcement 308 can function as a spring, or the reinforcement 308 may not have spring-like properties. For example, the reinforcement 308 can be a spring. For example, the reinforcement 308 can include spring material 164. As another example, the reinforcement 308 need not be a spring.

[0070] The reinforcement 308 can be, for example, a metal, an alloy, or a shape memory alloy.

[0071] The reinforcement 308 can have one or more functions. For example, the reinforcement 308 can allow radial expansion of the tube 160, inhibit kinking of the tube 160, inhibit crushing of the tube 160, transmit torque along the tube 160, reduce the force required to expand the tube 160, reduce the force required to advance a device (e.g., device 329) through the lumen 104 of the tube 160, or any combination thereof. The reinforcement 308 can be, for example, a radial expansion permitting function. The reinforcement 308 can be, for example, a kink inhibiting function. The reinforcement 308 can be, for example, a crush inhibiting function. The reinforcement 308 can be, for example, a torque transmitting function. The reinforcement body 308 (e.g., zigzag wire, vibrated wire, undulated wire) can combine the properties of both a coil (which can have poor torque performance but good kink and crush resistance) and a braid (which can have good torque performance but poor kink resistance). For example, the helical turn of the reinforcement body 308 around the lumen 104 can provide the reinforcement body 308 with the properties of a coil, and the zigzag shape of the reinforcement body 308 as it helically extends around the lumen 104 can provide the reinforcement body 308 with the properties of a braid. The reinforcement body 308 can provide the tube 160 with the ability to transmit torque and can allow the diameter of the tube 160 to increase (e.g., as the device is advanced through the lumen 104). The reinforcement body 310 can be, for example, a coil having a zigzag shape. As another example, the reinforcement 308 can be a coil that does not have a zigzag shape.

[0072] The reinforcement 308 can reduce the force required to expand the tube 160, for example, when the reinforcement 308 is or includes a spring or a shape memory alloy, and can reduce the force required to advance the device through the lumen 104.

[0073] For example, when the reinforcement body 308 includes a spring, the reinforcement body 308 can be attached to or integrated with the tube 160 (e.g., formed into or embedded in a layer of the tube 160) when the reinforcement body 308 is in the contracted configuration such that the reinforcement body 308 can be biased to expand when the tube 160 is in the unexpanded state. When the tube 160 is in the unexpanded state, the tube 160 can restrain the reinforcement body 308 such that the reinforcement body 308 can be restrained from expanding toward its neutral configuration. Because the tube 160 can restrain the reinforcement body 308 in the contracted configuration, the reinforcement body 308 can reduce the force required to expand the tube 160 when the device is advanced through the lumen 104. In other words, when tube 160 expands due to passage of a device (e.g., device 329) through lumen 104, reinforcement body 308 attempts to expand back to its neutral configuration, thereby reducing the force required to expand tube 160 and reduce the force required to advance the device through lumen 104. When the device is being withdrawn from lumen 104, tube 160 can re-constrain reinforcement body 308, allowing reinforcement body 308 to return to its contracted configuration. Returning to the contracted configuration can help prevent tube 160 from sticking to the vessel wall, thereby aiding in the removal of tube 160 from the vessel.

[0074] As another example, when reinforcement body 308 includes a shape memory alloy, reinforcement body 308 can be heated or energy activated to expand (e.g., expand radially). A device (e.g., device 329) in lumen 104 can transfer heat to reinforcement body 308, for example, through the wall of tube 160. For example, when thermal energy is transferred from the device to reinforcement body 308 as the device is advanced through lumen 104, reinforcement body 308 can increase in diameter, which can increase the diameter of tube 160, or reinforcement body 308 can be constrained by tube 160 to not expand but can nevertheless be biased to expand. When heat is transferred to the reinforcement body 308 or the reinforcement body 308 is otherwise activated (e.g., with an electric current), the reinforcement body 308 can expand or be biased to expand, which can radially expand the tube 160 or reduce the force required to radially expand the tube 160, which can reduce the force required to advance the device through the lumen 104. When the heat or energy activation source is removed, the tube 160 can re-constrain the reinforcement body 308 and return to a less expanded state (e.g., a non-expanded state) as the device is withdrawn from the lumen 104.

[0075] The reinforcement 310 can be, for example, a braid or a spiral wrap. As shown, the reinforcement 310 (e.g., a braid or spiral wrap) can have, for example, a clockwise element 310a and a counterclockwise element 310b. With respect to the braid, the clockwise element 310a and the counterclockwise element 310b can be interwoven with one another. For example, with respect to the braid, the clockwise element 310a can pass over and under the counterclockwise element 310b. With respect to a spiral wrap, instead of the clockwise elements 310a being interwoven with the counterclockwise elements 310b (e.g., over and under like a braid), all or substantially all (e.g., 80% to 99%) of the clockwise elements 310a can pass over all or substantially all (e.g., 80% to 99%) of the counterclockwise elements 310b, or all or substantially all (e.g., 80% to 99%) of the clockwise elements 310a can pass under all or substantially all (e.g., 80% to 99%) of the counterclockwise elements 310b. The reinforcement body 310 can be embedded within a layer of the tube 160 (e.g., within layer 302, within layer 304, or within layer 306), can be between two layers of the tube 160 (e.g., between layer 302 and layer 304, or between layer 304 and layer 306), can extend along the innermost surface of the tube 160, can extend along the outermost surface of the tube 160, or any combination thereof. For example, the reinforcement body 310 can be a braid or spiral wrap nested (e.g., embedded) within a layer of the tube 160. As another example, the reinforcement body 310 can overlie a layer of the tube 160. The reinforcement body 310 can extend around the lumen 104 of the tube 160. The lumen of the reinforcement body can be concentric with the lumen 104.

[0076] The stiffener 310 can function as a spring, or the stiffener 310 may not have spring-like properties. For example, the stiffener 310 can be a spring. As another example, the stiffener 310 may not be a spring.

[0077] The reinforcement 310 can be, for example, a metal, alloy, shape memory alloy, and / or polymer, whereby the clockwise element 310a and the counterclockwise element 310b can be strands or filaments of a metal, alloy, shape memory alloy, and / or polymer. The clockwise element 310a can be made of a different material than the counterclockwise element 310b. As another example, the clockwise element 310a and the counterclockwise element 310b can be made of the same material. The clockwise element 310a and the counterclockwise element 310b can be, for example, round or flat. Flat elements can provide a lower tubing profile, while round elements can provide a higher tensile strength.

[0078] The reinforcer 310 may be axially expandable, thereby allowing for axial expansion of the tube 160, and / or may be radially expandable, thereby allowing for radial expansion of the tube 160. Whether the reinforcer 310 is axially expandable and / or radially expandable may depend, for example, on the angle 311 between each of the elements 310a and 310b of the reinforcer 310 and the longitudinal axis 310x of the reinforcer 310 (e.g., whether the angle 311 is a low angle or a high angle), the dimensions of the elements, the number of elements, and the number of elements in proportion to the diameter of the tube 160. For example, whether the reinforcer 310 is axially expandable and / or radially expandable may depend on the angle 311 between the clockwise element 310a and the counterclockwise element 310b of the reinforcer 310 and the longitudinal axis 310x of the reinforcer 310 (e.g., the angle 311 between the clockwise element 310a and the longitudinal axis 310x of the reinforcer 310, and the angle 311 between the counterclockwise element 310b and the longitudinal axis 310x of the reinforcer 310). The angle 311 between the clockwise element 310a and the longitudinal axis 310x of the actuator 120 and the angle 311 between the counterclockwise element 310b and the longitudinal axis 310x of the actuator 120 may be the same. The longitudinal axis 310x may be, for example, the central longitudinal axis of the reinforcement body 310 (which may, for example, coincide with the longitudinal axis Ax of the tube 160), or may be an axis parallel to the central longitudinal axis of the reinforcement body 310 that intersects with the elements 310a and / or 310b.For example, a reinforcer 310 having a high angle 311 between the clockwise and counterclockwise elements 310a and 310b and the longitudinal axis 310x of the reinforcer 310 can be configured to expand more axially than it expands radially, while a reinforcer 310 having a low angle 311 between the clockwise and counterclockwise elements 310a and 310b and the longitudinal axis 310x of the reinforcer 310 can be configured to expand more radially than it expands axially. The high angle 311 between the clockwise and counterclockwise elements 310a and 310b and the longitudinal axis 310x of the reinforcer 310 can be, for example, 46 degrees to 90 degrees, or more narrowly, 46 degrees to 85 degrees, including one degree increments within these ranges (e.g., 46 degrees, 50 degrees, 60 degrees, 85 degrees, 90 degrees). The lower angle 311 between the clockwise and counterclockwise elements 310a, 310b and the longitudinal axis 310x of the reinforcement body 310 can be, for example, 0 to 45 degrees, or more narrowly, 5 to 45 degrees, including one degree increments within these ranges (e.g., 0, 5, 15, 45 degrees). The angle 311 between the clockwise and counterclockwise elements 310a, 310b and the longitudinal axis 310x of the reinforcement body 310 can be measured, for example, between the clockwise and counterclockwise elements 310a, 310b and the central longitudinal axis Ax of the tube 160 or a longitudinal axis parallel to the central longitudinal axis Ax of the tube 160. The angle between clockwise element 310a and counterclockwise element 310b referred to herein can be the angle between the elements when tube 160 is in a neutral or unexpanded state and / or when tube 160 is in an expanded state. For example, Figures 10A-18H show that clockwise element 310a and counterclockwise element 310b can intersect with one another at angle 316 when tube 160 is in an unexpanded state.Half of angle 316 can be angle 311 between clockwise and counterclockwise elements 310a, 310b and longitudinal axis 310x of stiffener 310. For example, longitudinal axis 310x of stiffener 310 can be an angle bisector (e.g., longitudinal axis 310x) that divides angle 316 into two equal angles, each equal to angle 311 between clockwise and counterclockwise elements 310a, 310b and longitudinal axis 310x of stiffener 310. As another example, FIGS. 10A-18H show that clockwise and counterclockwise elements 310a, 310b can intersect each other at angle 318 when tube 160 is in the expanded state. Half of angle 318 can be angle 311 between clockwise and counterclockwise elements 310a and 310b and longitudinal axis 310x of reinforcement 310. For example, longitudinal axis 310x of reinforcement 310 can be an angle bisector (e.g., longitudinal axis 310x) that divides angle 318 into two equal angles, each equal to angle 311 between clockwise and counterclockwise elements 310a and 310b and longitudinal axis 310x of reinforcement 310. Angle 318 can be the same as or different from angle 316. The expansion characteristics of reinforcement 310 when tube 160 is in an unexpanded state can depend on whether half of angle 316 is a low angle or a high angle. The expansion characteristics of the reinforcement 310 when the tube 160 is in an expanded state can depend on whether half of the angle 318 is a low angle or a high angle.

[0079] The upper end of the high angle range for angle 311 can be the maximum angle between the element of reinforcement 310 and the longitudinal axis 310x of reinforcement 310 that the element can have. The maximum high angle 311 between clockwise element 310a and counterclockwise element 310b can be, for example, 75 to 90 degrees, or more narrowly, 75 to 85 degrees, including one-degree increments within these ranges (e.g., 75, 80, 85, 90 degrees). The maximum achievable high angle 311 can depend, for example, on the element dimensions, the number of elements, and the number of elements relative to the diameter of tube 160. The larger the element dimensions, the greater the number of elements, and the more elements there are relative to the diameter of tube 160, the lower the maximum angle 311 can be (e.g., approaching or equal to 75 degrees). When the reinforcement 310 has the maximum high angle 311 between elements (e.g., 75 to 85 degrees), axial expansion of the reinforcement 310 is permitted but radial expansion is prevented. This is because when the reinforcement 310 has the maximum high angle 311 between elements, the diameter of the reinforcement 310 is at its largest and the length is at its smallest. In such a case, the reinforcement 310 is expandable in the axial direction but not in the radial direction.

[0080] The lower end of the low angle range for angle 311 can be the smallest angle an element can have between the element of reinforcement 310 and the longitudinal axis 310x of reinforcement 310. The minimum low angle 311 between clockwise element 310a and counterclockwise element 310b can be, for example, 0 to 15 degrees, or more narrowly, 5 to 15 degrees, including one-degree increments within these ranges (e.g., 0, 5, 10, 15 degrees). The achievable minimum low angle 311 can depend, for example, on the element dimensions, the number of elements, and the number of elements relative to the diameter of tube 160. The larger the element dimensions, the greater the number of elements, and the more elements there are relative to the diameter of tube 160, the higher the maximum angle 311 can be (e.g., approaching or equal to 15 degrees). When the reinforcement 310 has a minimum low angle 311 between elements (e.g., 5 to 15 degrees), radial expansion of the reinforcement 310 is permitted but axial expansion is prevented. This is because when the reinforcement 310 has a minimum low angle 311 between elements, the diameter of the reinforcement 310 is at its smallest and the length is at its largest. In such a case, the reinforcement 310 is radially expandable but not axially expandable.

[0081] For tubes 160 in which axial expansion of the tube 160 is desired, the tube 160 may have a reinforcement 310 having a high angle 311 (e.g., 46 to 85 degrees) between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310, as measured when the tube 160 is in a neutral or contracted state. For tubes 160 in which radial expansion is not desired (e.g., no radial expansion is desired), the tube 160 may have a reinforcement 310 having a maximum high angle 311 (e.g., 75 to 85 degrees) between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310, as measured when the tube 160 is in a neutral or contracted state.

[0082] For tubes 160 in which radial expansion of the tube 160 is desired, the tube 160 may have a reinforcement 310 having a low angle 311 (e.g., 5 to 45 degrees) between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310, as measured when the tube 160 is in a neutral or contracted state. For tubes 160 in which axial expansion is not desired (e.g., no axial expansion is desired), the tube 160 may have a reinforcement 310 having a minimum low angle 311 (e.g., 5 to 15 degrees) between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310, as measured when the tube 160 is in a neutral or contracted state.

[0083] The reinforcement 310 can thereby permit radial expansion of the tube 160 and prevent axial expansion of the tube 160 (e.g., when the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 is a minimum low angle), permit axial expansion of the tube 160 and prevent radial expansion of the tube 160 (e.g., when the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 is a maximum high angle), and / or permit radial and axial expansion of the tube 160 (e.g., when the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 is between a minimum low angle and a maximum high angle). With respect to the reinforcement 310 in any of the figures shown herein, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can be a low angle (e.g., a minimum low angle). With respect to the reinforcement 310 in any of the figures shown herein, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can be a high angle (e.g., a maximum high angle). With respect to the reinforcement 310 in any of the figures shown herein, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can be between a minimum low angle and a maximum high angle. Regardless of the angle between the elements of the reinforcement 310, the reinforcement 310 can transmit torque along the tube 160. The reinforcement 310 can, for example, be a torque transmission body. The reinforcement 310 can, for example, provide the tube 160 with the ability to transmit torque along the length of the tube 160. The angle 311 between the clockwise and counterclockwise elements 310a, 310b of the reinforcement 310 (e.g., braid or spiral wrap) and the number of clockwise and counterclockwise elements 310a, 310b can be optimized to control the expansion (axial and / or radial), torque, and stretch resistance of the tube 160 desired for a particular application.

[0084] For tube 160 having a reinforcement 310, the reinforcement 310 can allow radial expansion of tube 160 up to a radial expansion limit. For example, the maximum high angle 311 that the reinforcement 310 can achieve can be used to limit the radial expansion of tube 160. The radial expansion limit for the reinforcement 310 can be the same as or different from the radial expansion limit for the radial ePTFE. For example, the radial expansion limit for the reinforcement 310 can be a 5% to 200% increase in the diameter (e.g., inner diameter) of the tube 160, including 1% increments (e.g., 5%, 50%, 100%, 200%) within this range from a first diameter (e.g., diameter d1) to a second diameter (e.g., diameter d2). The first diameter d1 can be, for example, the unexpanded or neutral diameter of the tube 160. When the tube 160 has the first diameter, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can be smaller than the maximum high angle. The second diameter d2 can be, for example, the expanded diameter of the tube 160. When the tube 160 has the second diameter, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can be the maximum high angle. For example, for a tube 160 that is expandable from a first diameter (e.g., diameter d1) to a second diameter (e.g., diameter d2), if the first diameter (e.g., diameter d1) is 2 mm and the radial expansion limit of the reinforcement 310 is 100%, when the second diameter (e.g., diameter d2) of the tube 160 reaches 4 mm, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can become a maximum high angle, such that the reinforcement 310 can suppress or prevent further radial expansion of the tube 160.When the radial expansion limit of the reinforcement body 310 is reached (e.g., when the angle 311 between the elements of the reinforcement body 310 and the longitudinal axis 310x of the reinforcement body 310 reaches a maximum high angle), the reinforcement body 310 can inhibit or prevent further radial expansion of the radially stretched portion of the tube 160. For example, the reinforcement body 310 can allow radial expansion of the tube 160 when the tube 160 radially expands (e.g., from diameter d1 to diameter d2) as a device (e.g., device 329) is advanced along the lumen 104, but can limit the amount that the tube 160 can radially expand up to the radial expansion limit of the reinforcement body 310. The reinforcement body 310 can thereby inhibit or prevent radial expansion beyond the radial expansion limit of the reinforcement body 310. Reinforcement 310 can permit radial expansion to reduce the risk of layers 302, 304, and / or 306 being torn or punctured by a device as it is advanced axially through lumen 104. For such variations, radial ePTFE can mimic the properties of reinforcement 310, such that, for example, the radial ePTFE in one or more layers of tube 160 can eliminate the need or desire for reinforcement 310, given that the radial expansion limits of the radial ePTFE and reinforcement 310 can be the same or approximately the same. As another example, tube 160 can have radial ePTFE and reinforcement 310, in which case the radial ePTFE and reinforcement 310 can work together to inhibit or prevent axial expansion of tube 160 (e.g., as the device is advanced through lumen 104).

[0085] For tube 160 having reinforcement 310, reinforcement 310 can allow axial expansion of tube 160 up to an axial expansion limit. For example, the minimum low angle 311 that reinforcement 310 can achieve can be used to limit the axial expansion of tube 160. The axial expansion limit for reinforcement 310 can be the same as or different from the axial expansion limit for axial ePTFE. For example, the axial expansion limit for reinforcement 310 can be a 5% to 200% increase in the length of tube 160 (e.g., length 160L or any portion thereof), including 1% increments (e.g., 5%, 50%, 100%, 200%) within this range from the first length to the second length. The first length can be, for example, the unexpanded or neutral length of tube 160. When the tube 160 has a first length, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can be greater than the minimum low angle. The second length can be, for example, the expanded length of the tube 160. When the tube 160 has a second length, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can be the minimum low angle. For example, for a tube 160 that is expandable from a first length to a second length, if the first length is 10 cm and the axial expansion limit of the reinforcement 310 is 100%, when the second length of the tube 160 reaches 20 cm, the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 can be the minimum low angle, so that the reinforcement 310 can inhibit or prevent further axial expansion of the tube 160. When the axial expansion limit of the reinforcement 310 is reached (e.g., when the angle 311 between the elements of the reinforcement 310 and the longitudinal axis 310x of the reinforcement 310 reaches a minimum low angle), the reinforcement 310 can inhibit or prevent further axial expansion of the axially stretched portion of the tube 160.For example, reinforcement 310 can permit axial expansion of tube 160 when tube 160 expands axially (e.g., from a first length to a second length) as a device (e.g., device 329) is advanced along lumen 104, but can limit the amount that tube 160 can expand axially up to the axial expansion limit of reinforcement 310. Reinforcement 310 can thereby inhibit or prevent axial expansion beyond the reinforcement axial expansion limit. Reinforcement 310 can permit axial expansion to reduce the risk that layers 302, 304, and / or 306 will be torn or punctured by the device as it is advanced axially through lumen 104. For such variations, the axial ePTFE can mimic the properties of the reinforcement 310, such that, for example, the axial ePTFE in one or more layers of the tube 160 can eliminate the need or desire for the reinforcement 310, given that the axial expansion limits of the radial ePTFE and the reinforcement 310 can be the same or approximately the same. As another example, the tube 160 can have axial ePTFE and the reinforcement 310, in which case the axial ePTFE and the reinforcement 310 can work together to inhibit or prevent radial expansion of the tube 160 (e.g., as the device is advanced through the lumen 104).

[0086] Reinforcement 308 and / or reinforcement 310 can be attached to or integral with tube 160. For example, reinforcement 308 can be embedded in a layer of tube 160 via an extrusion or molding process, reinforcement 310 can be embedded in a layer of tube 160 via an extrusion or molding process, or both. For tube 160 having both reinforcement 308 and reinforcement 310, reinforcement 308 can be embedded in the same layer as reinforcement 310 or can be embedded in a different layer than reinforcement 310. As another example, reinforcement 308 can be positioned in a channel extending through a layer of tube 160, reinforcement 310 can be positioned in a channel extending through a layer of tube 160, or both. For tube 160 having both reinforcement 308 and reinforcement 310, reinforcement 308 can be in the same channel as reinforcement 310 or can be in a different channel than reinforcement 310. As another example, reinforcement 308 and / or reinforcement 310 can be sandwiched between two adjacent layers of tube 160. Reinforcement 308 can be in contact with reinforcement 310. As another example, reinforcement 308 need not be in contact with reinforcement 310.

[0087] The reinforcement 312 can be one or more strips (also referred to as strips) of material in one or more layers of the tube 160. The strips of material can be stiffer than adjacent materials in the same layer and / or stiffer than materials in adjacent layers. The strips of material can be, for example, longitudinal strips or spiral strips. As another example, the reinforcement 312 can include one or more longitudinal strips (also referred to as axial strips) and one or more curved strips. The longitudinal strips can be straight, while the curved strips can be curved, e.g., spiral. Layer 302, layer 304, and / or layer 306 can have the reinforcement 312. For example, the innermost layer (e.g., layer 302), the middle layer (e.g., layer 304), and / or the outermost layer (e.g., layer 302, layer 304, or layer 306) can have the reinforcement 312. The strip of material can be, for example, secondary material 166 (also referred to as strip material 166). The reinforcement 312 can include, for example, a low flexural modulus material such as PolyBlend 1100 45A material, polyurethane, SEBS, and / or Pebax™.

[0088] The reinforcement 312 allows the tube 160 to expand radially, but can inhibit or prevent the tube 160 from expanding axially when the device in the tube 160 is advanced through the lumen 104.

[0089] The functions of the different layers (eg, the liner and jacket) can depend, for example, on the materials that the tube 160 comprises and the reinforcements that the tube 160 has.

[0090] The one or more reinforcements and the one or more layers can be fused together. A hydrophilic coating can be applied to the inner and / or outer surfaces of the tube 160. As another example, a hydrophilic coating is not applied to the inner and / or outer surfaces of the tube 160.

[0091] Actuator Any of the tubes disclosed herein can have one or more actuators 120. A tube having an actuator 120 is labeled as tube 100 in the figures.

[0092] Actuator 120 can have any arrangement of features shown and / or described with respect to any combination of Figures 1A-4D and / or described elsewhere in this application, including, for example, features shown and / or described with reference to Figures 1A-1D, 2A-2D, 3A-3G, 4A and 4B, 4A-4D, and / or 26A-62. Actuator 120 can also be referred to by various other terms followed by the reference number 120, including, for example, element 120 and structural element 120.

[0093] The actuator 120 can be, for example, a tube as shown in FIGS. 1A-3G and 26A-45F, having a wall (also referred to as an actuator wall) and a lumen 322 (also referred to as an actuator lumen 322). The actuator 120 can be, for example, a cylindrically shaped tube. The actuator wall can circumferentially surround the actuator lumen 322. The actuator wall can surround the actuator lumen 322. The actuator lumen 322 can extend through the center of the actuator 120. As another example, the actuator 120 need not be a tube, but instead can be, for example, a shape memory alloy that is heat-activated or energy-activated to expand from its natural length 126 to its expanded length 130. In such a case, the actuator 120 may or may not have a lumen (e.g., lumen 322).

[0094] Actuator 120 can be made from one or more materials (e.g., one material, two materials, three materials, four materials, five materials, or more than five materials, e.g., 6-10 materials, including increments of one material within this range). Actuator 120 can include, for example, PTFE, ePTFE, a fluoroelastomer, a fluoroelastomer, a composite of fluoroelastomer and ePTFE (e.g., FLUOROSLIX), or any combination thereof. Other materials are also recognized, including, for example, any combination of materials disclosed or contemplated in this patent application. Fluoroelastomer and ePTFE composites are further described in U.S. Patent Application Serial No. 15 / 891,024, filed February 7, 2018 (U.S. Patent Application Publication No. 2018 / 0344981), which is incorporated herein by reference in its entirety for all purposes. For example, actuator 120 can be made from a composite material of fluoroelastomer and ePTFE. The ePTFE can be axial ePTFE and / or radial ePTFE. FIGS. 1A-2D and 26A-45F illustrate, for example, that actuator 120 can include PTFE, ePTFE, or a fluoroelastomer. For example, actuator 120 can be an extruded tube of PTFE, ePTFE, a fluoroelastomer, or a composite material. FIGS. 3A-3G illustrate, for example, that actuator 120 can include two materials, such as, for example, a first polymer and a second polymer.

[0095] Actuator 120 can have one or more layers, such as tube 160. For example, actuator 120 can have one layer, two layers, three layers, or four or more layers. For example, Figures 26a-45F and 51A-62 show that actuator 120 can have one layer.

[0096] The actuator 120 may have a reinforcement 132. The reinforcement 132 may be within (e.g., embedded in) the actuator wall or may extend along the innermost or outermost surface of the actuator 120. As another example, the actuator 120 may not have a reinforcement 132.

[0097] The reinforcement body 132 can be, for example, a coil, a vibrated wire (e.g., a zigzag wire) that is helically wound around the lumen 322 within the wall of the actuator 120, a braid, or a spiral wrap. Figures 29A-37D, 41A-41D, and 45A-45F show, for example, that the reinforcement body 132 can be a braid or a spiral wrap that can have clockwise and counterclockwise elements 132a and 132b. With respect to the braid, the clockwise and counterclockwise elements 132a and 132b can be interwoven with one another such that the clockwise element 132a can pass over and under the counterclockwise element 132b. For a spiral wrap, instead of clockwise elements 132a being interwoven with counterclockwise elements 132b (e.g., over and under like a braid), all or substantially all (e.g., 80% to 99%) of clockwise elements 132a can pass over or under all or substantially all (e.g., 80% to 99%) of counterclockwise elements 132b, or vice versa. As an additional example, reinforcement 132 can be reinforcement 308 positioned in the wall of actuator 132 extending helically around lumen 322 for one or more turns, reinforcement 310 positioned in the wall of actuator 120 extending circumferentially around lumen 322 for one or more turns, reinforcement 312 in the wall of actuator 120, or any combination thereof.

[0098] The reinforcement 132 can be within (e.g., embedded in) the actuator wall. The actuator 120 (e.g., the actuator wall and actuator lumen 322) can be within (e.g., embedded in) a layer of the tube 100 (e.g., within layer 302, within layer 304, or within layer 306), between two layers of the tube 100 (e.g., between layer 302 and layer 304, or between layer 304 and layer 306), extend along the innermost surface of the tube 100, extend along the outermost surface of the tube 100, or any combination thereof. For example, the reinforcement 132 can be a nested braid or spiral wrap within the wall of the actuator 120, and the actuator 120 can be a nested tube that is spirally wrapped around the lumen 104 of the tube 100, e.g., embedded in layer 302, layer 304, or layer 306. For example, the actuator 120 may extend helically around the lumen 104 of the tube 100 .

[0099] The stiffener 132 can function as a spring, or the stiffener 132 may not have spring-like properties. For example, the stiffener 132 can be a spring. As another example, the stiffener 132 may not be a spring.

[0100] The reinforcement 132 can be, for example, a metal, an alloy, a shape memory alloy, and / or a polymer, whereby the clockwise element 132a and the counterclockwise element 132b can be strands or filaments of a metal, an alloy, a shape memory alloy, and / or a polymer. The clockwise element 132a can be made of a different material than the counterclockwise element 132b. As another example, the clockwise element 132a and the counterclockwise element 132b can be made of the same material. The clockwise element 132a and the counterclockwise element 132b can be, for example, round or flat. Flat elements can provide a lower tubing profile, while round elements can provide higher tensile strength.

[0101] For variations in which the reinforcement 132 includes a braid or spiral wrap, the reinforcement 132 may be axially expandable, thereby allowing axial expansion of the actuator 120, and / or radially expandable, thereby allowing radial expansion of the actuator 120. Whether the reinforcement 132 is axially expandable and / or radially expandable may depend, for example, on the angle 133 between each of the elements 132a and 132b of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 (e.g., whether the angle 133 is a low angle or a high angle), the dimensions of the elements, the number of elements, and the number of elements relative to the diameter of the actuator 120. For example, whether the reinforcer 132 is axially expandable and / or radially expandable may depend on the angle 133 between the clockwise element 132a and the counterclockwise element 132b of the reinforcer 132 and the longitudinal axis 132x of the reinforcer 132 (e.g., the angle 133 between the clockwise element 132a and the longitudinal axis 132x of the reinforcer 132, and the angle 133 between the counterclockwise element 132b and the longitudinal axis 132x of the reinforcer 132). The angle 133 between the clockwise element 132a and the longitudinal axis 132x of the actuator 120 and the angle 133 between the counterclockwise element 132b and the longitudinal axis 132x of the actuator 120 may be the same. The longitudinal axis 132x can be, for example, the central longitudinal axis of the reinforcer 310 or an axis parallel to the central longitudinal axis of the reinforcer 310 that intersects with the elements 132a and / or 132b. For example, a reinforcer 132 having a high angle 133 between the clockwise and counterclockwise elements 132a and 132b and the longitudinal axis 132x of the reinforcer 132 can be configured to expand more axially than it expands radially, while a reinforcer 132 having a low angle 133 between the clockwise and counterclockwise elements 132a and 132b and the longitudinal axis 132x of the reinforcer 132 can be configured to expand more radially than it expands axially.The high angle 133 between the clockwise and counterclockwise elements 132a and 132 and the longitudinal axis 132x of the reinforcement 132 can be, for example, 46 degrees to 90 degrees, or more narrowly, 46 degrees to 85 degrees, including one-degree increments within these ranges (e.g., 46 degrees, 50 degrees, 60 degrees, 85 degrees, 90 degrees). The low angle 133 between the clockwise and counterclockwise elements 132a and 132 and the longitudinal axis 132x of the reinforcement 132 can be, for example, 0 degrees to 45 degrees, or more narrowly, 5 degrees to 45 degrees, including one-degree increments within these ranges (e.g., 0 degrees, 5 degrees, 15 degrees, 45 degrees). When the actuator 120 is in an unactuated state, the angle 133 can be a low angle or a high angle. For example, FIGS. 26A-45F show that angle 133 can be a high angle when actuator 120 is in an unactuated state. For example, angle 133 between clockwise element 132a and counterclockwise element 132b can be the angle between the elements when actuator 120 is unpressurized or otherwise at a baseline pressure (e.g., pressure P0). When actuator 120 is in an actuated state, angle 133 can be a low or high angle. Angle 133 can be larger when actuator 120 is in an actuated state than when actuator 120 is in an unactuated state. Angle 133 can be smaller when actuator 120 is in an actuated state than when actuator 120 is in an unactuated state. For example, FIGS. 26A-45F show that angle 133 can be smaller when actuator 120 is in an actuated state than when actuator 120 is in an unactuated state. The angle between the clockwise element 132a and the counterclockwise element 132b referred to herein can be the angle between the elements when the tube 100 is in a neutral or unexpanded state and / or when the tube 100 is in an expanded state.26A-45F show that when tube 100 is in an unexpanded state (e.g., when actuator 120 is in an unactuated state), clockwise element 132a and counterclockwise element 132b can intersect with one another at angle 326. Half of angle 326 can be angle 133 between clockwise element 132a and counterclockwise element 132b and longitudinal axis 132x of reinforcement body 132. For example, longitudinal axis 132x of reinforcement body 132 can be an angle bisector (e.g., longitudinal axis 132x) that divides angle 326 into two equal angles, each equal to angle 133 between clockwise element 132a and counterclockwise element 132b and longitudinal axis 132x of reinforcement body 132. 26A-45F illustrate that when tube 100 is in the expanded state (e.g., when actuator 120 is in the actuated state), clockwise element 132a and counterclockwise element 132b can intersect with one another at angle 328. Half of angle 328 can be angle 133 between clockwise element 132a and counterclockwise element 132b and longitudinal axis 132x of reinforcement body 132. For example, longitudinal axis 132x of reinforcement body 132 can be an angle bisector (e.g., longitudinal axis 132x) that divides angle 328 into two equal angles, each equal to angle 133 between clockwise element 132a and counterclockwise element 132b and longitudinal axis 132x of reinforcement body 132. Angle 328 can be the same as angle 326 or can be different from angle 326. The expansion characteristics of the reinforcement 132 when the tube 100 is in an unexpanded state can depend on whether half of the angle 326 is low or high. The expansion characteristics of the reinforcement 132 when the tube 100 is in an expanded state can depend on whether half of the angle 328 is low or high.

[0102] The upper end of the high angle range for angle 133 can be the maximum angle between the element of reinforcement 132 and the longitudinal axis 132x of reinforcement 132 that the element can have. The maximum high angle 133 between clockwise element 132a and counterclockwise element 132b can be, for example, 75 to 90 degrees, or more narrowly, 75 to 85 degrees, including one-degree increments within these ranges (e.g., 75, 80, 85, 90 degrees). The maximum achievable high angle 133 can depend, for example, on the element dimensions, the number of elements, and the number of elements relative to the diameter of actuator 120. The larger the element dimensions, the greater the number of elements, and the more elements there are relative to the diameter of actuator 120, the lower the maximum angle 133 can be (e.g., approaching or equal to 75 degrees). When the reinforcement 132 has the highest angle 133 between elements (e.g., 75 to 85 degrees), axial expansion of the reinforcement 132 is permitted but radial expansion is prevented. This is because when the reinforcement 132 has the highest angle 133 between elements, the diameter of the reinforcement 132 may be at its largest and the length may be at its smallest. In such a case, the reinforcement 132 may be expandable in the axial direction but not in the radial direction.

[0103] The lower end of the low angle range for angle 133 can be the smallest angle an element can have between the element of reinforcement 132 and the longitudinal axis 132x of reinforcement 132. The smallest low angle 133 between clockwise element 132a and counterclockwise element 132b can be, for example, 0 to 15 degrees, or more narrowly, 5 to 15 degrees, including one-degree increments within these ranges (e.g., 0, 5, 10, 15 degrees). The smallest achievable low angle 133 can depend, for example, on the element dimensions, the number of elements, and the number of elements relative to the diameter of actuator 120. The larger the element dimensions, the greater the number of elements, and the more elements there are relative to the diameter of actuator 120, the higher the minimum angle 133 can be (e.g., approaching or equal to 15 degrees). When the reinforcement 132 has a minimum low angle 133 between elements (e.g., 5 to 15 degrees), radial expansion of the reinforcement 132 is permitted but axial expansion is prevented. This is because when the reinforcement 132 has a minimum low angle 133 between elements, the diameter of the reinforcement 132 may be at its smallest and the length may be at its largest. In such a case, the reinforcement 132 may be radially expandable but not axially expandable.

[0104] For tubes 100 in which axial expansion of actuator 120 is desired, actuator 120 may have reinforcement 132 with a high angle 133 (e.g., 46 to 85 degrees) between elements of reinforcement 132 and longitudinal axis 132x of reinforcement 132, as measured when actuator 120 is in an unactuated state. For tubes 100 in which radial expansion is not desired (e.g., no radial expansion is desired), actuator 120 may have reinforcement 132 with a maximum high angle 133 (e.g., 75 to 85 degrees) between elements of reinforcement 132 and longitudinal axis 132x of reinforcement 132, as measured when actuator 120 is in an unactuated state.

[0105] For tubes 100 in which radial expansion of actuator 120 is desired, actuator 120 may have reinforcement 132 with a low angle 133 (e.g., 5 to 45 degrees) between elements of reinforcement 132 and longitudinal axis 132x of reinforcement 132, as measured when actuator 120 is in an unactuated state. For tubes 100 in which axial expansion is not desired (e.g., no axial expansion is desired), actuator 120 may have reinforcement 132 with a minimum low angle 133 (e.g., 5 to 15 degrees) between elements of reinforcement 132 and longitudinal axis 132x of reinforcement 132, as measured when actuator 120 is in an unactuated state.

[0106] The reinforcement 132 is thereby capable of permitting radial expansion of the actuator 120 and preventing axial expansion of the actuator 120 (e.g., when the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 is a minimum low angle), permitting axial expansion of the actuator 120 and preventing radial expansion of the actuator 120 (e.g., when the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 is a maximum high angle), and / or permitting radial and axial expansion of the actuator 120 (e.g., when the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 is between a minimum low angle and a maximum high angle). With respect to the reinforcement 132 in any of the figures shown herein, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be a low angle (e.g., a minimum low angle). With respect to the reinforcement 132 in any of the figures shown herein, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be a high angle (e.g., a maximum high angle). With respect to the reinforcement 132 in any of the figures shown herein, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be between a minimum low angle and a maximum high angle. Regardless of the angle between the elements of the reinforcement 132, the reinforcement 132 can transmit torque along the actuator 120. The reinforcement 132 can, for example, be a torque transmitting body. The reinforcement 132 can, for example, provide the tube 100 with the ability to transmit torque along the length of the tube 100. Thereby, reinforcement 132 can function as reinforcement 310. As such, for variations in which reinforcement 132 includes a braid or spiral wrap, reinforcement 132 in actuator 120 can eliminate the need or desire for reinforcement 310 in tube 100.The angle 133 between the clockwise and counterclockwise elements 132a, 132b of the reinforcement 132 (e.g., braid or spiral wrap) and the number of clockwise and counterclockwise elements 132a, 132b can be optimized to control the expansion (e.g., axial and / or radial), torque, and stretch resistance of the actuator 120 desired for a particular application.

[0107] For variations in which the reinforcement 132 includes a braid or spiral wrap, the reinforcement 132 can allow radial expansion of the actuator 120 up to a radial expansion limit. For example, the maximum high angle 133 that the reinforcement 132 can achieve can be used to limit the radial expansion of the actuator 120. For example, the radial expansion limit of the reinforcement 132 can be a 5% to 200% increase in the diameter (e.g., inner diameter) of the actuator 120, including 1% increments (e.g., 5%, 50%, 100%, 200%) within this range from a first diameter (e.g., first width 120w1) to a second diameter (e.g., second width 120w2). The first diameter can be, for example, the unexpanded or neutral diameter of the actuator 120. When the actuator 120 has a first diameter, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be less than the maximum high angle. The second diameter can be, for example, the expanded diameter of the actuator 120. When the actuator 120 has a second diameter, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be the maximum high angle. For example, for an actuator 120 expandable from a first diameter to a second diameter, if the first diameter is 2 mm and the radial expansion limit of the reinforcement 132 is 100%, when the second diameter of the actuator 120 reaches 4 mm, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be the maximum high angle, such that the reinforcement 132 can inhibit or prevent further radial expansion of the actuator 120. When the radial expansion limit of the reinforcement 132 is reached (e.g., when the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 reaches a maximum high angle), the reinforcement 132 can inhibit or prevent further radial expansion of the radially stretched portion of the actuator 120.For example, the reinforcement 132 can permit radial expansion of the actuator 120 when the actuator 120 expands radially from a first diameter to a second diameter as the device (e.g., device 329) is advanced along the lumen 104, but can limit the amount by which the actuator 120 can expand radially up to the radial expansion limit of the reinforcement 132. The reinforcement 132 can thereby inhibit or prevent radial expansion beyond the radial expansion limit of the reinforcement 132. For example, the reinforcement 132 can permit radial expansion of the actuator 120 when the actuator 120 expands radially as pressure is increased in the actuator 120 (e.g., from pressure P to pressure P), but can limit the amount by which the actuator 120 can expand radially up to the radial expansion limit of the reinforcement 132. Permitting such radial expansion can, for example, reduce the risk that pressure in the actuator 120 will cause the actuator 120 to rupture. Radial ePTFE can mimic the properties of reinforcement 132 when a maximum high angle 133 between elements of reinforcement 132 and longitudinal axis 132x of reinforcement 132 is used to limit the radial expansion of actuator 120; for example, when actuator 120 includes radial ePTFE, radial ePTFE in one or more layers of actuator 120 (e.g., actuator 120 including a tube of radial ePTFE) can eliminate the need or desire for reinforcement 132 in actuator 120, given that radial ePTFE can similarly allow radial expansion of actuator 120 up to its radial expansion limit. For example, actuator 120 (e.g., actuator wall) can have radial ePTFE but no reinforcement 132.As another example, actuator 120 can have radial ePTFE and reinforcement 132, in which case, the radial ePTFE and reinforcement 132 can work together to inhibit or prevent axial expansion of actuator 120 when pressure is increased in actuator 120 (e.g., from pressure P to pressure P). In such a case, reinforcement 132 can be embedded in the radial ePTFE, for example. As another example, reinforcement 132 can be in ePTFE (e.g., not radial ePTFE). When actuator 120 is depressurized (e.g., from pressure P to pressure P), reinforcement 132 and / or radial ePTFE can assist in reducing the diameter of actuator 120 (e.g., from an expanded diameter to a collapsed diameter).

[0108] For variations in which the reinforcement 132 includes a braid or spiral wrap, the reinforcement 132 can allow axial expansion of the actuator 120 up to an axial expansion limit. For example, the minimum low angle 133 that the reinforcement 132 can achieve can be used to limit the axial expansion of the actuator 120. The axial expansion limit of the reinforcement 132 can be, for example, a 5% to 200% increase in the length of the actuator 120 (e.g., the total length of the actuator 120), including 1% increments (e.g., 5%, 50%, 100%, 200%) within this range from the first length (e.g., length 126) to the second length (e.g., length 130). The first length can be, for example, the unextended or neutral length of the actuator 120. When the actuator 120 has a first length, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be greater than a minimum low angle. The second length can be, for example, the expanded length of the actuator 120. When the actuator 120 has a second length, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be a minimum low angle. For example, for an actuator 120 that is expandable from a first length to a second length, if the first length is 10 cm and the axial expansion limit of the reinforcement 132 is 100%, when the second length of the actuator 120 reaches 20 cm, the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 can be a minimum low angle such that the reinforcement 132 can inhibit or prevent further axial expansion of the actuator 120. When the axial expansion limit of the reinforcement 132 is reached (e.g., when the angle 133 between the elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 reaches a minimum low angle), the reinforcement 132 can inhibit or prevent further axial expansion of the axially stretched portion of the actuator 120.For example, the reinforcement 132 can permit axial expansion of the actuator 120 when the actuator 120 expands axially from a first length to a second length as the device (e.g., device 329) is advanced along the lumen 104, but can limit the amount by which the actuator 120 can expand axially up to the axial expansion limit of the reinforcement 132. The reinforcement 132 can thereby inhibit or prevent axial expansion beyond the reinforcement axial expansion limit. For example, the reinforcement 132 can permit axial expansion of the actuator 120 when the actuator 120 expands radially as pressure is increased in the actuator 120 (e.g., from pressure P to pressure P), but can limit the amount by which the actuator 120 can expand axially up to the axial expansion limit of the reinforcement 132. Permitting such axial expansion can, for example, reduce the risk that pressure in the actuator 120 will cause the actuator 120 to rupture. Axial ePTFE can mimic the properties of the reinforcement 132 when a minimum low angle 133 between elements of the reinforcement 132 and the longitudinal axis 132x of the reinforcement 132 is used to limit the axial expansion of the actuator 120; for example, when the actuator 120 includes axial ePTFE, the axial ePTFE can similarly allow axial expansion of the actuator 120 up to its axial expansion limit, such that axial ePTFE in one or more layers of the actuator 120 (e.g., an actuator 120 including a tube of axial ePTFE) can eliminate the need or desire for the reinforcement 132 in the actuator 120. For example, the actuator 120 (e.g., the actuator wall) can have axial ePTFE but no reinforcement 132.As another example, actuator 120 can have axial ePTFE and reinforcement 132, in which case, the axial ePTFE and reinforcement 132 can work together to inhibit or prevent radial expansion of actuator 120 when pressure is increased in actuator 120 (e.g., from pressure P0 to pressure P1). In such a case, reinforcement 132 can be embedded in axial ePTFE, for example. As another example, reinforcement 132 can be in ePTFE (e.g., not axial ePTFE). When actuator 120 is depressurized (e.g., from pressure P1 to pressure P0), reinforcement 132 and / or axial ePTFE can assist in reducing the length of actuator 120 (e.g., from length 130 to length 126).

[0109] The reinforcement 132 can have one or more functions. For example, for variations in which the reinforcement 132 includes a braid or spiral wrap, the reinforcement 132 can transmit torque along the tube 100, or it can allow the actuator 120 to retain an amount of pressure (e.g., pressure P1) such that when pressure is applied to the actuator 120 (e.g., when pressure in the lumen 322 of the actuator 120 is increased from pressure P0 to pressure P1), the reinforcement 132 can prevent the diameter of the actuator 120 from increasing while allowing the length of the actuator 120 to increase, or both. The reinforcement 132 can, for example, be a torque transmitter. The reinforcement 132 can, for example, allow the actuator 120 to increase from length 126 to length 130 while not allowing the radius of the actuator 120 to increase. The angle 133 between the (e.g., braided or spiral wrapped) clockwise elements 132a and counterclockwise elements 132b of the reinforcement 132, as well as the number of clockwise elements 132a and counterclockwise elements 132b, can be optimized to control the expansion, torque, and stretch resistance of the actuator 120 desired for a particular application.

[0110] Actuator 120 can have one or more functions, for example, actuator 120 can allow radial expansion of tube 100, inhibit or prevent axial expansion of tube 100, inhibit kinking of tube 100, inhibit crushing of tube 100, transmit torque along tube 100, reduce the force required to expand tube 100, reduce the force required to advance a device (e.g., device 329) through lumen 104 of tube 100, or any combination thereof.

[0111] Actuator 120 can be a reinforcement within the wall of tube 100. Actuator 120 can function as a reinforcement within the wall of tube 100. For example, actuator 120 can function as a reinforcement within the wall of tube 100 when actuator 120 is in an activated state (e.g., an inflated state) and / or when actuator 120 is in a non-activated state (e.g., an uninflated or deflated state). For example, when actuator 120 is in an activated state, actuator 120 can become rigid (e.g., when pressurized at pressure P1) to prevent kinking of tube 160 and / or prevent crushing of tube 100. Actuator 120 can, for example, be more rigid in an activated state than in a non-activated state. As another example, when actuator 120 is in an activated state (e.g., an inflated state), actuator 120 can inhibit or prevent axial expansion of tube 100. The actuator 120 can, for example, function as an inflatable reinforcement 308 having a helical shape (e.g., with or without a vibrating pattern, such as the vibrating patterns of the actuators 120 shown in FIGS. 1A, 3C, 3E, and 3G) such that when the actuator 120 is activated, it can inhibit kinking of the tube 100, inhibit crushing of the tube 100, or both. As another example, the reinforcement 308 can be the actuator 120. As another example, the tube 100 can have two reinforcements 308, one of which can be a wire and another of which can be an actuator 120.

[0112] For example, FIGS. 29A-37D, 41A-41D, and 45A-45F illustrate that the reinforcement body 132 can form a hollow coil that can extend helically around the lumen 104. The reinforcement body 132 can form a coil having a lumen 322, for example. For example, FIGS. 29A-37D, 41A-41D, and 45A-45F illustrate that the reinforcement body 132 can be a braid or a spiral wrap, whereby the braid or spiral wrap can form a coil that extends around the lumen 104. In this manner, the reinforcement body 132 can function as both a braid and a coil, or as both a spiral wrap and a coil. The reinforcement body 132 can thereby have the properties of a coil, whereby the reinforcement body 132 can inhibit or prevent the tube 100 from kinking and / or inhibit or prevent the tube 100 from crushing. While coils typically have poor torque capabilities, coils formed by braiding or spiral wrapping, such as those shown in Figures 29A-37D, 41A-41D, and 45A-45F, can transmit torque along the length of the tube, thereby allowing reinforcement 132 to be, for example, a coil having lumen 322 extending around lumen 104.

[0113] Any of the tubes disclosed herein (e.g., tube 160, tube 100, actuator 120) can have any of the features disclosed herein (e.g., disclosed above) in any combination. For example, tube 100 (e.g., active tube) and tube 160 (e.g., passive tube) can have any combination of the features disclosed herein (e.g., any combination of the features described above). The features described above can, for example, be arranged in any combination to produce active tube 100 and passive tube 160 that can expand and contract, for example, as shown in the figures.

[0114] Passive Tube Figures 6A-25D show example combinations and arrangements of the features described above. All combinations and subcombinations of the features shown and / or described with respect to Figures 6A-25D are also possible.

[0115] 6A-25D illustrate, for example, various passive tubes 160 (also referred to as various other terms followed by the reference number 160, including, for example, tube 160, tubing 160, dynamic-walled tube 160, and passive dynamic-walled tube 160) having various benefits. Each tube 160 can expand and contract to accommodate the passage of a device (e.g., device 329) through the tube 160. For example, each tube 160 can passively expand when the device is advanced along the lumen 104, and each tube 160 can passively contract when the device is retracted from the lumen 104. The tubes 160 can be passively expandable and contractible. The tubes 160 can have an unexpanded state (also referred to as an unexpanded state, a non-expanded state, or other similar terms, including, for example, a natural or neutral state) and an expanded state. The unexpanded state can be the relaxed or natural state of the tube 160. The unexpanded state can be a contracted (e.g., fully contracted) state of tube 160. When a device (e.g., device 329) is advanced through lumen 104, tube 160 can passively change from the unexpanded state to the expanded state via the device (e.g., device 329) pushing radially outward against the wall of tube 160. When the device is withdrawn from lumen 104, tube 160 can passively change from the expanded state to the unexpanded state.

[0116] 6A-6D show variations of the tube 160. The tube 160 can be, for example, a catheter. The tube 160 can be, for example, an introducer. The tube 160 can have a proximal end 160p and a distal end 160d (also referred to as the tube proximal end 160p and the tube distal end 160d, respectively). The proximal end 160p can have a handle 330 and a valve 332 (e.g., a hemostatic valve). The distal end 160d can have a tip 334. The tip 334 can be, for example, an atraumatic tip. The tip 334 can be passively expandable. The tip 334 can be actively expandable. For example, the tip 334 can include the expandable tip shown in FIGS. 5A-5C. The tube 160 can include a tip 334, or the tip 334 can be attached to or integral with the distal end 160d of the tube 160. The tip 334 can be fixedly attached to the distal end 160d. The tip 334 can be removably attached to the distal end 160d via, for example, a friction fit, a magnetic fit, a snap fit, and / or a clip fit (e.g., using one or more clips). The tube 160 can have a length 160L. The length 160L can be, for example, 10 cm to 200 cm, including 1 cm increments within this range (e.g., 10 cm, 20 cm, 50 cm, 100 cm, 150 cm, 200 cm). The tube 160 can be insertable into a blood vessel. Tube 160 can be expanded and contracted while in the blood vessel, for example, by advancing and withdrawing a device (e.g., device 329) into and from lumen 104 of tube 160. For example, Figures 6C and 6D show that device 329 can be advanced in direction 329a and withdrawn in direction 329b, and that directions 329a and 329b can be opposite one another.

[0117] 6A-6D illustrate that tube 160 can be bendable, expandable, and contractible. FIG. 6A illustrates tube 160 in a straight, unexpanded configuration. FIG. 6B illustrates tube 160 in a curved, unexpanded configuration. FIG. 6C illustrates tube 160 in a straight, expanded configuration. FIG. 6D illustrates tube 160 in a curved, expanded configuration. FIGS. 6A-6D illustrate that tube 160 can bend and straighten as it is navigated through a blood vessel, and that tube 160 can expand and contract, for example, as a device (e.g., device 329) is advanced through and withdrawn from a lumen (e.g., lumen 104) within tube 160. Device 329 can be, for example, an oversized device or an oversized instrument. For example, device 329 can have a width (e.g., diameter) that is greater than the diameter lumen 104 when tube 160 is in the unexpanded configuration. For example, the width (e.g., diameter) of device 329 can be greater than diameter d1 by, for example, 1 mm to 30 mm or more, or more narrowly, 1 mm to 20 mm, or even more narrowly, 1 mm to 15 mm, including 1 mm increments within these ranges (e.g., 1 mm, 5 mm, 10 mm, 15 mm, 20 mm, 30 mm). For example, Figures 6A and 6B show tube 160 before a device (e.g., device 329) is advanced therethrough, Figures 6A and 6B show tube 160 after a device (e.g., device 329) has been withdrawn from tube 160, and Figures 6C and 6D show tube 160 after a device (e.g., device 329) has been advanced through lumen 104 of tube 160. 6B and 6D show that the tube 160 can have a curved portion 336 when the tube 160 is in a curved configuration.

[0118] Sections S1, S2, S3, and S4 in FIGS. 6A-6D each mark the same section of tube 160. For example, sections S1, S2, S3, and S4 in FIGS. 6A-6D each mark section 160s1 (also referred to as tube section 160s1 and first tube section 160s1) of tube 160. In other words, sections S1, S2, S3, and S4 in FIGS. 6A-6D each mark the boundaries of the same section of tube 160, i.e., the boundaries of section 160s1. Sections S1, S2, S3, and S4 are used for reference in describing the following figures. Portions of tube 160 proximal and distal to tube section 160s1 can be the same as or different from tube section 160s1. Section 160s1 can have a proximal end 160s1p and a distal end 160s1d (also referred to as section proximal end 160s1p and section distal end 160s1d, respectively). Section 160s1 can have a length 160s1L. Length 160s1L can be less than length 160L. For example, length 160s1L can be 1 cm to 199 cm, or more narrowly, 1 cm to 100 cm, including 1 cm increments within these ranges (e.g., 1 cm, 5 cm, 10 cm, 20 cm, 30 cm, 40 cm, 50 cm, 100 cm, 150 cm, 199 cm).

[0119] Sections S5, S6, S7, and S8 in FIGS. 6A-6D each mark the same section of tube 160. For example, sections S5, S6, S7, and S8 in FIGS. 6A-6D each mark section 160s2 (also referred to as tube section 160s2 and second tube section 160s2). In other words, sections S5, S6, S7, and S8 in FIGS. 6A-6D each mark the boundaries of the same section of tube 160, i.e., section 160s2. Sections S5, S6, S7, and S8 are used for reference in describing the following figures. The portion of tube 160 proximal to tube section 160s2 can be the same as tube section 160s2 or can be different from tube section 160s2. Section 160s2 can have a proximal end 160s2p and a distal end 160s2d (also referred to as section proximal end 160s2p and section distal end 160s2d, respectively). Section 160s2 can have a length 160s2L. Length 160s2L can be equal to or less than length 160L. For example, length 160s2L can be 1 cm to 200 cm, or more narrowly, 1 cm to 100 cm, including 1 cm increments within these ranges (e.g., 1 cm, 5 cm, 10 cm, 20 cm, 50 cm, 100 cm, 150 cm, 200 cm). Length 160s2L can be the same as length 160s1 or different from length 160s1. Section distal end 160s2d can, for example, be the distal terminal end of tube 160. As another example, as shown in Figures 6A and 6C, tip 334 can extend from section 160s2 (e.g., from section distal end 160s2d).

[0120] 6A-6D show that torsional loads 354a and 354b can be applied to tube 160, for example, by rotating handle 330 in direction 353a (e.g., torsional load 354a) or by rotating handle 330 in direction 353b (e.g., torsional load 354b). Direction 353a can be clockwise and direction 353b can be counterclockwise, or vice versa.

[0121] Figures 7A-7D show variations of the tube 160 of Figures 6A-6D. For example, Figure 7A shows a close-up of section S1 of the tube 160 of Figure 6A, and Figure 7B shows a close-up of section S2 of the tube 160 of Figure 6C.

[0122] 7A-7D show that tube 160 can include three layers, for example, a first layer (e.g., layer 302), a second layer (e.g., layer 304), and a third layer (e.g., layer 306). The first layer can be an inner layer, the second layer can be a middle layer, and the third layer can be an outer layer. For example, the second layer can be between the outer surface of the first layer and the inner surface of the third layer along the length of tube 160.

[0123] 7A-7D show that layer 302 can be a first tube, layer 304 can be a second tube, and layer 306 can be a third tube. The first tube can be an inner tube, the second tube can be a middle tube, and the third tube can be an outer tube. A lumen (e.g., lumen 104) can extend through the first, second, and third tubes. The first, second, and third tubes can share a common lumen (e.g., lumen 104). For example, FIGS. 7A-7D show that lumen 104 can extend through the longitudinal centers of all three tubes. The first, second, and third tubes can have the same length as each other or different lengths from each other. For example, Figures 7A-7D show that the first, second, and third tubes can each have the same length (e.g., length 160L) but different diameters (e.g., the first tube can have a smaller diameter than the second tube, which can have a smaller diameter than the third tube).

[0124] The reinforcement 308 can be within (e.g., embedded in) the tube 160. For example, Figures 7A-7D show that the reinforcement 308 can be within (e.g., embedded in) the layer 304 (e.g., within the second tube).

[0125] The reinforcement body 308 can extend around the lumen 104 for one or more turns 308t (also referred to as one turn 308t, the turn 308t, and multiple turns 308t), for example, from 1 to 1000 turns 308t, including turn increments within this range (e.g., 1 turn, 2 turns, 10 turns, 100 turns, 200 turns, 300 turns, 400 turns, 500 turns, 1000 turns), and / or any partial turns (e.g., one-quarter of a full turn, one-half of a full turn, or three-quarters of a full turn with respect to the first and / or last turn of the reinforcement body 308). For example, FIGS. 7A-7D show that the reinforcement body 308 can extend helically around the lumen 104 for one or more turns 308t.

[0126] 7A-7D show that the reinforcement 308 can have a profile 338. The profile 338 can include turns 308t. The profile 338 can be a non-helical profile, a helical profile, or a profile having one or more non-helical sections and one or more helical sections. For example, FIGS. 7A-7D show that the profile 338 can be a helical profile having a helix angle 340 and a pitch 342. The helix angle 340 can be the angle between the central longitudinal axis Ax of the tube 160 (e.g., of the lumen 104) and the central longitudinal axis of the profile 338. The helix angle 340 can be, for example, from 1 degree to 30 degrees, or more narrowly, from 1 degree to 10 degrees, including one-degree increments within these ranges (e.g., 1 degree, 5 degrees, 10 degrees, 15 degrees, 20 degrees, 30 degrees). The pitch 342 can be the distance between adjacent turns 308t of the reinforcement 308. The pitch 342 can be, for example, 0.0 mm to 15.0 mm, or more narrowly, 0.0 mm to 10.0 mm, or even more narrowly, 0.0 mm to 5.0 mm, including 0.1 mm increments within these ranges (e.g., 0.0 mm, 1.0 mm, 2.5 mm, 5.0 mm, 7.5 mm, 10.0 mm, 12.5 mm, 15.0 mm). When the pitch 342 is 0.00 mm, adjacent turns 308t of the reinforcement 308 can be in contact with one another. The helix angle 340 and / or the pitch 342 can vary along the turn 308t or can be constant along the length of the reinforcement 308 (e.g., along the length of the profile 338).7A-7D illustrate that the profile 338 can include at least one full turn 308t, that the profile 338 can include a diameter, that the turns 308t can be continuous (e.g., uninterrupted) with one another along the length of the profile 338, and that adjacent turns 308t can be spaced apart and not touching along the length of the profile 338. As another example, adjacent turns 308t can touch one another along the length of the profile 338.

[0127] 7A-7D show that the reinforcing body 308 can have an oscillating shape 344. As another example, the reinforcing body 308 need not have an oscillating shape 344, such that the reinforcing body 308 can be a coil with no undulations along either the entire length of the reinforcing body 308 or a portion thereof. While FIGS. 7A-7D show that the oscillating shape 344 can be, for example, a zigzag shape, any oscillating shape is recognized, including, for example, the shape of any waveform (e.g., a sine wave, a square wave, a triangular wave, or a sawtooth wave). The oscillating shape 344 can be consistent or can vary along the length of the reinforcing body 308. For example, FIGS. 7A-7D show that the oscillating shape 344 can be consistent (e.g., have the same wave pattern) along the length of the reinforcing body, such as along the turn 308t. The oscillating shape 344 can be, for example, a periodic waveform.

[0128] 7A-7D show that the reinforcer 308 can include arms 344a that intersect or meet to form peaks 344p (also referred to as crowns) and valleys 344v. The arms 344a can be integral with one another, such that the reinforcer 308 can be, for example, a continuous strand of material (e.g., a continuous strand of metal wire). The arms 344a, peaks 344p, and / or valleys 344v can define an oscillating shape 344.

[0129] 7A-7D show that each peak 344p can be a point where two adjacent arms 344a meet or intersect with one another, and that each valley 344v can be a space or gap between two adjacent arms 344a. For example, FIGS. 7A-7D show that a peak 344p (e.g., the apex of the peak 344p) can be opposite a valley 344v (e.g., the base of the valley 344v). In other words, the base of one of the valleys 344v can be opposite each peak 344p. For example, FIGS. 7A-7D show that two arms 344a that intersect with one another can define both a peak 344p and a valley 344v, thereby allowing the apex of the peak 344p to be opposite the base of the valley 344v. The peaks 344p can be angular, rounded, and / or flat. For example, FIGS. 7A-7D show that the peaks 344p can be angular, such that the peaks 344p can define corners (e.g., pointed corners, sharp corners). As another example, the peaks 344p can be rounded, such that the peaks 344p can define rounded corners or curved crests. The bases of the valleys 344v can be straight or curved. For example, FIGS. 7A-7D show that the bases of the valleys 344v can be straight, such that the valleys 344v can define spaces having a triangular shape. The shape of the valleys can depend, for example, on the corrugation of the reinforcement 308. For example, with respect to a zigzag shape (e.g., the zigzag shape shown in FIGS. 7A-7D), the peaks 344p can define corners where two arms 344a intersect, and the valleys 344v can be the spaces between two adjacent arms 344a. The reinforcer 308 can be a unitary structure (e.g., a single wire, a single unitary wire) including the arms 344a that define the peaks 344p and valleys 344v.For example, the reinforcement 308 can be a wire (eg, a single wire) having a vibrated shape 344 as shown in Figures 7A-7D.

[0130] The peak 344p can include a first peak 344p1 and a second peak 344p2. The first peak 344p1 can be a crest of the vibrated shape 344, and the second peak 344p2 can be a trough of the vibrated shape 344, or vice versa. The first peak 344p1 and the second peak 344p2 can face in opposite directions. For example, FIGS. 7A-7D show that the first peak 344p1 can face distally, e.g., toward the distal end 160d (e.g., toward the section distal end 160s1d), and the second peak 344p2 can face proximally, e.g., toward the proximal end 160p (e.g., toward the section proximal end 160s1p), or vice versa.

[0131] The valleys 344v may include a first valley 344v1 and a second valley 344v2. The first valley 344v1 may be the space between two adjacent first peaks 344p1, and the second valley 344v2 may be the space between two adjacent second peaks 344p2, or vice versa. The first valley 344v1 and the second valley 344v2 may open in opposite directions. For example, Figures 7A-7D show that the first valley portion 344v1 can be distally open, e.g., open toward the distal end 160d (e.g., toward the section distal end 160s1d), and the second valley portion 344v2 can be proximally open, e.g., open toward the proximal end 160p (e.g., toward the section proximal end 160s1p), or vice versa.

[0132] 7A-7D show that the first peak portion 344p1 can be on the opposite side (e.g., directly opposite) of the second valley portion 344v2, and that the second peak portion 344p2 can be on the opposite side (e.g., directly opposite) of the first valley portion 344v1.

[0133] 7A-7D illustrate that the peaks 344p and valleys 344v can be aligned (e.g., longitudinally and circumferentially aligned) along an axis 344x. For example, the axis 344x can bisect the peaks 344p and valleys 344v. The axis 344x can extend around the lumen 104 (e.g., spirally around the lumen 104). For example, FIGS. 7A and 7B illustrate that the axis 344x can extend spirally around a central longitudinal axis Ax of the tube 160 (e.g., of the lumen 104), such that the peaks 344p and valleys 344v of adjacent turns 308t can extend spirally around the central longitudinal axis Ax. FIGS. 7A and 7B illustrate, for example, that the axis 344x can include a first axis 344x1 and a second axis 344x2. The first axis 344x1 can extend along the first set of peaks 344p and valleys 344v and through the first peaks 344p1 and second valleys 344v2 of the adjacent turn 308t, and the second axis 344x2 can extend along the second set of peaks 344p and valleys 344v and through the second peaks 344p2 and first valleys 344v1 of the adjacent turn 308t. For example, Figures 7A and 7B show that the first peaks 344p1 and second valleys 344v2 of the adjacent turn 308t can be aligned along the first axis 344x1, and the second peaks 344p2 and first valleys 344v1 of the adjacent turn 308t can be aligned along the second axis 344x2. 7A and 7B show, for example, that the first axis 344x1 can bisect the first peak 344p1 and the second valley 344v2, and that the second axis 344x2 can bisect the second peak 344p2 and the first valley 344v1. The axes 344x can be parallel to each other. For example, FIGS. 7A and 7B show that the axes 344x1 and 344x2 can be parallel to each other.As another example, the axis 344x extending through the first peak portion 344p1 and the second valley portion 344v2 can be angled (e.g., non-parallel) with respect to the axis 344x extending through the second peak portion 344p2 and the first valley portion 344v1.

[0134] The arms 344a, peaks 344p, and valleys 344v of the reinforcer 308 can be spaced apart from each other at regular or irregular intervals. Figures 7A and 7B show exemplary variations of reinforcer 308 having arms 344a, peaks 344p, and valleys 344v spaced apart at regular intervals. The vibrated shape 344 can have any arrangement of features, such as those shown in Figures 7A-7D. Figures 7A-7D show that the characteristics or parameters of the vibrated shape 344 can include the distance 344d (e.g., wavelength), height 344h (e.g., peak-to-peak height), arm length 344aL, angle 345 between adjacent arms 344a, number of turns 308t, and / or the relative positions and arrangements of the peaks 344p and valleys 344v.

[0135] 7A and 7B show that the arms 344a can each have an arm length 344aL. The arm length 344aL can be, for example, from about 2 mm to about 15 mm, including 1 mm increments within this range (e.g., 2 mm, 5 mm, 10 mm, 15 mm). The arms 344a can have uniform or non-uniform lengths. For example, FIGS. 7A and 7B show that the arms can have a uniform length, such as, for example, arm length 344aL. Adjacent arms 344a can have the same or different lengths relative to each other. For example, FIGS. 7A and 7B show that the arms 344a can have the same length as each other, such as, for example, arm length 344aL. As another example, the arm length 344aL can be non-uniform (e.g., it can be variable, e.g., some arms 344a can be 2 mm long, some arms 344a can be 4 mm long, or any other length or combination thereof).

[0136] 7A and 7B show that the vibrated shape 344 can define a distance 344d between two adjacent first peaks 344p1 and / or two adjacent second peaks 344p2. The distance 344d between two adjacent first peaks 344p1 can be the same as the distance between two adjacent second peaks 344p2. The distance 344d can be, for example, the wavelength of the vibrated shape 344. The wavelength can be measured between two adjacent crests (e.g., between the first peaks 344p1) or between two adjacent troughs (e.g., between the second peaks 344p2). The distance 344d can be, for example, from about 2 mm to about 20 mm, including 1 mm increments within this range (e.g., 2 mm, 5 mm, 10 mm, 15 mm, 20 mm).

[0137] 7A and 7B show that the vibrated shape 344 can define a height 344h. The height 344h can be the peak-to-peak distance between a first peak 344p1 and a second peak 344p2. The height 344h can be, for example, from about 2 mm to about 10 mm, including 1 mm increments within this range (e.g., 2 mm, 5 mm, 10 mm). One-half of the height 344h can be the amplitude of the vibrated shape 344.

[0138] 7A and 7B show that angle 345 can be between adjacent arms 344a. Angle 345 can be, for example, from 1 degree to 180 degrees, or more narrowly from 5 degrees to 175 degrees, or more narrowly from 30 degrees to 120 degrees, including 1 degree increments within these ranges (e.g., 1 degree, 10 degrees, 20 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 120 degrees, 170 degrees, 179 degrees).

[0139] The peaks 344p can move relative to one another when the tube 160 expands, contracts, bends, straightens, or any combination thereof. For example, the peaks 344p (e.g., adjacent peaks 344p) of the reinforcement 308 can move away from and toward one another during radial expansion and contraction of the tube 160, respectively. For example, FIGS. 7A and 7B show that the peaks 344p (e.g., adjacent corners) can be closer to one another when the tube 160 is in an unexpanded state (e.g., FIG. 7A) than when the tube 160 is in an expanded state (e.g., FIG. 7B). FIG. 7A shows that the unexpanded state can be the natural state of the tube 160 or the contracted state of the tube 160. FIG. 7B shows that the expanded state can be a partially expanded state or a fully expanded state of the tube 160. 7A and 7B show, for example, that when tube 160 is expanded from an unexpanded state to an expanded state, distance 344d can increase from a first distance 344d1 to a second distance 344d2, and that when tube 160 is contracted from an expanded state to an unexpanded state, distance 344d can decrease from the second distance 344d2 to the first distance 344d1.

[0140] When the tube 160 is in an unexpanded state (e.g., FIG. 7A), the first distance 344d1 (e.g., wavelength, linear distance, or circumferential distance) between adjacent peak portions 344p can be, for example, 2 mm to 20 mm, including 1 mm increments within this range (e.g., 2 mm, 3 mm, 5 mm, 7 mm, 10 mm, 20 mm).

[0141] When the tube 160 is in an expanded state (e.g., FIG. 7B ), the second distance 344d2 (e.g., wavelength, linear distance, or circumferential distance) between adjacent peaks 344p can be, for example, 1 mm to 30 mm greater than the first distance 344d1, including 1 mm increments within this range (e.g., 3 mm, 4 mm, 7 mm, 9 mm, 15 mm, 30 mm). The maximum 30 mm amount assumes, for example, that the arm length 344aL is 15 mm and that the reinforcement 308 is completely straight or almost completely straight (95% to 99% straight) when the tube 160 is in the expanded configuration. In the case where the reinforcement 308 is completely straight when the tube 160 is expanded, the peaks 344p and valleys 344v can be completely flat, thereby allowing the reinforcement 308 to have a helical coil shape without a zigzag shape.

[0142] The difference in distance 344d between adjacent peaks 344p when tube 160 is in an expanded state (e.g., FIG. 7B) compared to when tube 160 is in an unexpanded state (e.g., FIG. 7C) can be, for example, 1 mm to 30 mm, including 1 mm increments within this range (e.g., 1 mm, 2 mm, 4 mm, 8 mm, 30 mm). For example, FIGS. 7A and 7B show that the difference in distance between adjacent corners when tube 160 is in an expanded state (e.g., FIG. 7B) compared to when tube 160 is in an unexpanded state (e.g., FIG. 7C) can be 5 mm. As another example, reinforcement 308 can be completely straight, such that reinforcement 308 does not have peaks 344p when tube 160 is in the expanded configuration. In such a case, distance 344d may not be present when tube 160 is in the expanded configuration. In such a case, when the tube 160 is in an unexpanded state (e.g., FIG. 7A), the reinforcement 308 may have a vibrated shape 344, and when the tube 160 is in an unexpanded state (e.g., FIG. 7B), the reinforcement 308 may not have any undulations, such that the reinforcement 308 may appear like a coil.

[0143] 7A and 7B show, for example, that height 344h can decrease from first height 344h1 to second height 344h2 when tube 160 is expanded from an unexpanded state to an expanded state, and that height 344h can increase from second height 344h2 to first height 344h1 when tube 160 is contracted from an expanded state to an unexpanded state. When tube 160 is in the unexpanded state (e.g., FIG. 7A), first height 344h1 can be, for example, 1.5 mm to 15.0 mm, including 0.1 mm increments within this range (e.g., 1.5 mm, 2.0 mm, 2.5 mm, 5.0 mm, 10.0 mm, 15.0 mm). When tube 160 is in the expanded state (e.g., FIG. 7B), second height 344h2 can be, for example, 0.0 mm to 15.0 mm, including 0.1 mm increments within this range (e.g., 0.0 mm, 0.1 mm, 1.0 mm, 1.2 mm, 1.7 mm, 2.2 mm, 4.7 mm, 9.7 mm, 14.0 mm, 15.0 mm). The difference between second height 344h2 when tube 160 is in the expanded state (e.g., FIG. 7B) compared to first height 344h1 when tube 160 is in the unexpanded state (e.g., FIG. 7C) can be, for example, 0.0 mm to 15.0 mm, including 0.1 mm increments within this range (e.g., 0.0 mm, 0.1 mm, 2.0 mm, 15.0 mm). 7A and 7B show that the difference between the first height 344h1 and the second height 344h2 can be 2.0 mm. When the difference between the first height 344h1 and the second height 344h2 is 0.0 mm, the height 344h does not change as the tube 160 expands and contracts. In other words, the first height 344h1 can be the same as the second height 344h2.When the difference between first height 344h1 and second height 344h2 is equal to first height 344h1, the undulations (e.g., peaks 344p) of reinforcement body 308 can completely straighten during expansion, such that when tube 160 is in an expanded state (e.g., the state shown in FIG. 7B ), reinforcement body 308 can extend helically around lumen 104 without peaks 344p. In such a case, when tube 160 is in an unexpanded state (e.g., FIG. 7A ), reinforcement body 308 can have an oscillating shape 344, and when tube 160 is in an unexpanded state (e.g., FIG. 7B ), reinforcement body 308 can have no undulations and can appear like a coil.

[0144] 7A and 7B show, for example, that angle 345 can increase from first angle 345a to second angle 345b when tube 160 is expanded from an unexpanded state to an expanded state, and that angle 345 can decrease from second angle 345b to first angle 345a when tube 160 is contracted from an expanded state to an unexpanded state. When tube 160 is in the unexpanded state (e.g., FIG. 7A), first angle 345a can be, for example, from 10 degrees to 170 degrees, or more narrowly, from 30 degrees to 120 degrees, including one-degree increments within these ranges (e.g., 10 degrees, 20 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 120 degrees, 170 degrees). When tube 160 is in the expanded state (e.g., FIG. 7B ), second angle 345b can be, for example, 10 degrees to 180 degrees, or more narrowly, 10 degrees to 150 degrees, including one-degree increments within these ranges (e.g., 10 degrees, 11 degrees, 20 degrees, 31 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 120 degrees, 180 degrees). The difference between first angle 345a and second angle 345b can be, for example, 0 degrees to 120 degrees, including one-degree increments within this range. For example, FIGS. 7A and 7B show that the difference between first angle 345a and second angle 345b can be 30 degrees. When the difference between first angle 345a and second angle 345b is 0 degrees, angle 345 does not change as tube 160 expands and contracts. In other words, first angle 345a can be the same as second angle 345b. When the difference between first angle 345a and second angle 345b is equal to first angle 345a, the undulations (e.g., peaks 344p) of reinforcement 308 can be completely straightened during expansion, such that reinforcement 308 can extend helically around lumen 104 without peaks 344p when tube 160 is in an expanded state (e.g., the state shown in FIG. 7B ).The reinforcement 308 can be in a fully expanded state (e.g., fully radially expanded state) when the angle 345 (e.g., first angle 345a, second angle 345b) is between 90 degrees and 180 degrees, including one degree increments within this range (e.g., 90 degrees, 170 degrees, 180 degrees). When the angle 345 is 180 degrees, the reinforcement 308 can be completely straight, such that the reinforcement 308 forms a helical coil with no zigzags.

[0145] 7A and 7B show, for example, that helix angle 340 can increase from first helix angle 340a to second helix angle 340b when tube 160 is expanded from an unexpanded state to an expanded state, and that helix angle 340 can decrease from second helix angle 340b to first helix angle 340a when tube 160 is contracted from an expanded state to an unexpanded state. The difference between first angle 345a and second angle 345b can be, for example, 0.0 degrees to 10.0 degrees, including 0.1 degree increments within this range (e.g., 0.0 degrees, 0.1 degrees, 2.5 degrees, 10.0 degrees). When the difference between first helix angle 340a and second helix angle 340b is 0.0 degrees, helix angle 340 does not change when tube 160 expands and contracts. In other words, the first helix angle 340a can be the same as the second helix angle 340b.

[0146] 7A and 7B show that a peak 344p can be within a valley 344v. A peak 344p can be considered to be within a valley 344v, for example, when the peak 344p is between the arms 344a that define the valley 344v. For example, FIGS. 7A and 7B show that a first peak 344p1 can be within a second valley 344v2, and that a second peak 344p2 can be within a first valley 344v1. For example, FIGS. 7A and 7B show that a first peak 344p1 can be within a second valley 344v2 defined by adjacent turns of the reinforcement 308, and that a second peak 344p2 can be within a first valley 344v1 defined by adjacent turns of the reinforcement 308. When peak 344p is within valley 344v, peak 344p can be considered to be nested within valley 344v. When peak 344p is outside valley 344v, peak 344p can be considered to be separated from valley 344v (also referred to as being non-nested with valley 344v). FIGS. 7A and 7B, for example, show that peak 344p can be nested within valley 344v. Peak 344p can be within valley 344v before and / or after expansion of tube 160. For example, FIG. 7A shows that peak 344p can be within valley 344v when tube 160 is in an unexpanded state and / or when tube 160 is in a contracted state, and FIG. 7B shows that peak 344p can be within valley 344v when tube 160 is in an expanded state. Reinforcement 308 can be considered to have a nested configuration, for example, when peaks 344p are nested within valleys 344v, and reinforcement 308 can be considered to have a separated configuration (also referred to as a non-nested configuration), for example, when peaks 344p are outside valleys 344v. For example, Figures 7A-7D show that reinforcement 308 can have a nested configuration.

[0147] 7A and 7B show that the valleys 344v can overlap one another. For example, FIGS. 7A and 7B show hash lines in two of the first valleys 344v1 and in two of the second valleys 344v2, indicating that a portion of the valleys 344v (e.g., the base of the valleys 344v) can overlap an adjacent valley 344v in an overlap region 346. Other overlap regions between adjacent valleys are shown in FIGS. 7A and 7B but are not labeled or indicated by overlapping hash lines.

[0148] The reinforcement 308 may inhibit kinking of the tube 160, inhibit crushing of the tube 160, transmit torque along the tube 160, or any combination thereof. As another example, if the reinforcement 308 (e.g., zigzag wire) comprises a spring or a shape memory alloy, the reinforcement 308 may inhibit kinking of the tube 160, inhibit crushing of the tube 160, transmit torque along the tube 160, reduce the force required to expand the tube 160, reduce the force required to advance a device through the lumen 104 of the tube 160, or any combination thereof.

[0149] 7A and 7B show that the reinforcement 308 is capable of transmitting torsional loads 354a and 354b exerted on the tube 160 (e.g., at the tube proximal end 160p) along the length of the tube 160, for example, along the arm 344a of the reinforcement 308 and across the valley 344v, as the force from the torsional loads 354a and 354b propagates along the reinforcement 308 and the tube 160 from the proximal end 160p to the distal end 160d.

[0150] 7A-7D show that the reinforcement 308 can be located (e.g., embedded) within the layer 304 (e.g., within the second tube). The reinforcement 308 can extend, for example, through the layer 304 (e.g., the second tube) between the inner and outer surfaces of the layer 304 along the length of the tube 160 (e.g., along the entire length 160L or along any length of the tube 160 less than the length 160L, including, for example, 1% to 99% of the length 160L, including 1% increments within this range).

[0151] The layers of tube 160 in Figures 7A-7D can be made from a variety of materials. For example, in a first material variation, one of the layers can include PTFE, one of the layers can include a fluoroelastomer, and one of the layers can include ePTFE, where the ePTFE can be ePTFE, axial ePTFE, radial ePTFE, or any combination thereof. For example, Figures 7A-7D show that layer 302 can include PTFE, layer 304 can include a fluoroelastomer, and layer 306 can include ePTFE. The ePTFE can be radial ePTFE or axial ePTFE. Tube 160 with this combination of material layers can offer unique advantages over the existing state-of-the-art for passively expandable tubes. For example, the combination of materials in this exemplary first variation of materials allows layer 302 to be harder than layer 306, layer 306 to be more elastic than layer 302, and layer 304 to inhibit or prevent reinforcement 308 from peeling and sliding between layers 302 and 306.

[0152] The PTFE layer (e.g., layer 302) can, for example, inhibit or prevent a device (e.g., device 329) in lumen 104 from puncturing and / or tearing layer 302 as the device is advanced through lumen 104. The PTFE layer can thereby allow a sharp device or a device without an atraumatic tip to be advanced along lumen 104 without puncturing or tearing tube 160. As another example, the PTFE in layer 302 can inhibit or prevent axial stretching of tube 160 as a device (e.g., device 329) is advanced along lumen 104, which can eliminate the need or desire for a reinforcement (e.g., reinforcement 310) to inhibit or prevent axial stretching of tube 160 as a device is passed through tube 160 through lumen 104. This can allow a device having a larger diameter than tube 160 to be advanced along lumen 104 without the need for reinforcement 310 in the wall of tube 160 to prevent axial expansion. For example, as the device is advanced along lumen 104, PTFE can allow a device (e.g., device 329) to radially expand tube 160, but can restrain the device from expanding tube 160 axially. Because PTFE can restrain axial expansion of tube 160 but allow radial expansion, PTFE can eliminate the need or desire for reinforcement 310 (e.g., braid or spiral wrap) in the layers of tube 160 (e.g., in layer 302, layer 304, and / or layer 306). In other words, the PTFE in layer 302 can inhibit or prevent a device being advanced through lumen 104 from pushing the portion of tube 160 distal to the tip of the device away from the portion of tube 160 proximal to the tip of the device, which can thereby limit or prevent axial elongation of tube 160 as it expands radially.The PTFE layer (e.g., layer 302) in the first variation of material can thereby resist axial tension when tube 160 radially expands, for example, from a radial force RF exerted by a device as it is advanced longitudinally through lumen 104. While PTFE can eliminate the need or desire for reinforcement 310, as another example, reinforcement 310 (e.g., a braid or spiral wrap) can be embedded in one of the layers (e.g., in layer 302, layer 304, or layer 306). In such a case, reinforcement 310 can, for example, transmit torque and reduce or prevent axial expansion of tube 160 that would otherwise be permitted by the PTFE in layer 302. Reinforcement 310 can thereby reduce or eliminate axial stretchability of tube 160. FIGS. 10A-12H show exemplary variations in which tube 160 has reinforcement 310, for example, in layer 306.

[0153] A fluoroelastomer layer (e.g., layer 304) can be more flexible and have a higher coefficient of friction than PTFE and ePTFE, allowing the fluoroelastomer to better prevent delamination of reinforcement 308 from itself than from PTFE or ePTFE. In other words, it may take more force to delaminate reinforcement 308 from layer 304 when layer 304 includes a fluoroelastomer than when layer 304 includes PTFE or ePTFE. A more stretchable and tackier fluoroelastomer, for example, can inhibit reinforcement 308 from slipping between layers 302 and 306, preventing radial and / or axial expansion and contraction of tube 160 from delaminating reinforcement 308 from the material in layer 304. For example, a fluoroelastomer may better inhibit or prevent delamination of reinforcement 308 from between layers 302 and 306 when layer 304 includes a fluoroelastomer than when layer 304 includes PTFE or ePTFE. However, as an additional example, layer 304 may include PTFE or ePTFE instead of a fluoroelastomer.

[0154] In a first variation of materials, the ePTFE layer (e.g., layer 306) can provide elasticity to tube 160 with, for example, axial ePTFE and / or radial ePTFE, depending on the desired direction of elasticity. When layer 306 includes axial ePTFE, tube 160 can have the benefits associated with axial ePTFE (e.g., as described above), allowing axial expansion and inhibiting or preventing radial expansion. When layer 306 includes radial ePTFE, tube 160 can have the benefits associated with radial ePTFE (e.g., as described above), allowing radial expansion and inhibiting or preventing axial expansion. Radial ePTFE in layer 306 (or in any other layer) can reduce the force required to radially expand tube 160, for example, compared to axial ePTFE or PTFE in a layer (e.g., in layer 306). Axial ePTFE in layer 306 (or in any other layer) can reduce the force required to axially expand tube 160, for example, compared to radial ePTFE or PTFE in a layer (e.g., in layer 306).

[0155] In a first variation of the material, the ePTFE in layer 306 can be radial ePTFE (e.g., without axial ePTFE). For tube 160 having radial ePTFE instead of axial ePTFE (e.g., in layer 306), the radial ePTFE can combine the elastic benefits of transversely redirected ePTFE (e.g., given that radial ePTFE is tailored to stretch radially rather than axially) with properties that mimic the benefits of reinforcement 310 (e.g., given that radial ePTFE can allow radial expansion but limit or prevent axial expansion). For example, radial ePTFE can improve the resilience provided by axial ePTFE by being more conductive to stretch in the radial direction than in the axial direction, and can also function, for example, as reinforcement 310 (e.g., a braid or spiral wrap) in tube 160, along with PTFE in layer 302, by constraining axial expansion of tube 160 when a device (e.g., device 329) is advanced longitudinally along lumen 104. Radial ePTFE can thereby solve the problem of both providing radial resilience while simultaneously limiting axial resilience. In other words, radial ePTFE in one or more layers of tube 160 (e.g., in layer 306 in FIGS. 7A-7D ) can have the combined effect of ePTFE and reinforcement 310 in tube 160.

[0156] Because radial ePTFE is radially expandable in the radial direction, the radial ePTFE in tube 160 (e.g., in layer 306) can reduce the force required to expand tube 160 when a device (e.g., device 329) is advanced through tube 160, compared to the same tube 160 having axial ePTFE in tube 160 (e.g., in layer 306) instead of radial ePTFE. This, in turn, can reduce the force required to advance the device along lumen 104 of tube 160. The resistance of radial ePTFE to axial elongation can also assist the PTFE in layer 302 in eliminating the need or desire for reinforcement 310 in tube 160, thereby further eliminating the need or desire for reinforcement 310 in tube 160. In a first variation of materials, layers 302 and 306 of PTFE and radial ePTFE, respectively, can inhibit or prevent axial expansion of tube 160; layer 306 can reduce the force required to radially expand the tube, which can reduce the amount of force required to push the device along lumen 104.

[0157] As another example, in a first material variation, the ePTFE in layer 306 can include axial ePTFE (e.g., without radial ePTFE). For tube 160 having axial ePTFE instead of radial ePTFE (e.g., in layer 306), the axial ePTFE can allow tube 160 to stretch axially when the device is advanced along lumen 104, unless, for example, the PTFE in layer 302, a reinforcement (e.g., reinforcement 310), or a material in another layer prevents it.

[0158] The ePTFE in layer 306 (e.g., axial ePTFE or radial ePTFE) can strengthen tube 160 by increasing the overall thickness (e.g., thicknesses T1 and T2) of tube 160, as opposed to having only layers 302 and 304 in FIGS. 7A-7D without layer 306. As another example, the ePTFE in layer 306 can provide tube 160 with a low-friction outer surface, such that the ePTFE can eliminate the need or desire for a hydrophilic coating on the outer surface of tube 160. For example, the ePTFE can have a lower coefficient of friction than the coefficient of friction of the fluoroelastomer in layer 304. Although the ePTFE can eliminate the need or desire for a hydrophilic outer coating, as another example, layer 306 can have a hydrophilic outer coating to further reduce friction on the outer surface of tube 160.

[0159] In a second variation of materials, for example, with respect to tube 160 in Figures 7A-7D, one of the layers can include a fluoroelastomer, one of the layers can include ePTFE, and one of the layers can include ePTFE (i.e., two of the layers of tube 160 can include ePTFE). The type of ePTFE in the two ePTFE layers can be the same as each other, e.g., axial ePTFE and / or radial ePTFE, or can be different from each other. For example, Figures 7A-7D show that layer 302 can include ePTFE, layer 304 can include a fluoroelastomer, and layer 306 can include ePTFE, such that the fluoroelastomer is sandwiched (e.g., circumferentially sandwiched) between the two ePTFE layers. The ePTFE in layer 302 can be radial or axial ePTFE, and the ePTFE in layer 306 can be radial or axial ePTFE. Tube 160 with this combination of material layers can offer unique advantages. For example, the material combination in this exemplary second material variation allows layer 302 to be softer than layer 302 in the first material variation, which can reduce the force required to radially expand tube 160 for the second material variation compared to the first material variation; layer 304 can inhibit or prevent reinforcement 308 from peeling and sliding between layers 302 and 306; and layer 306 can be the same or a different material as layer 302. Layer 302 can be an inner ePTFE layer, and layer 306 can be an outer ePTFE layer. The ePTFE is, for example, a softer material than the PTFE in the first material variation. This allows the ePTFE in the second variation of the material (e.g., in layer 302) to require less force to expand than the PTFE in the first variation of the material (e.g., in layer 302).The use of ePTFE in layer 302 in the second variation of material can thereby provide a lower insertion force than PTFE in layer 302 in the first variation of material for an oversized instrument to be slid through tube 160. The device advanced through lumen 104 can be, for example, an oversized device or instrument (e.g., another catheter, an endoscope, a sensor, an implant, etc.). Thus, while the PTFE layer (e.g., layer 302) in the first variation of material provides advantages, the ePTFE layer (e.g., layer 302) in the second variation of material also provides advantages.

[0160] The inner ePTFE layer (e.g., layer 302) can include axial ePTFE and / or radial ePTFE. Radial ePTFE can reduce the force required to radially expand tube 160 and push a device along lumen 104, for example, relative to an arrangement in which layer 302 includes PTFE or any other material that is harder than ePTFE. Axial ePTFE can reduce the force required to axially expand tube 160 and push a device along lumen 104, for example, relative to an arrangement in which layer 302 includes PTFE or any other material that is harder than ePTFE. Moreover, a layer of radial ePTFE (e.g., an inner layer) can reduce the force required to radially expand tube 160 compared to, for example, a layer of axial ePTFE (e.g., an inner layer), and a layer of axial ePTFE (e.g., an inner layer) can reduce the force required to axially expand tube 160 compared to, for example, a layer of radial ePTFE (e.g., an inner layer).

[0161] The fluoroelastomer layer (e.g., layer 304) in the second variation of the material can provide the same benefits as those described in connection with the fluoroelastomer layer (e.g., layer 304) in the first variation of the material.

[0162] The outer ePTFE layer (e.g., layer 306) can comprise axial ePTFE or radial ePTFE. In both cases, this layer can strengthen tube 160 by increasing the overall thickness (e.g., thicknesses T1 and T2) of tube 160, as opposed to having only layers 302 and 304 in FIGS. 7A-7D without layer 306, and can provide tube 160 with a low-friction outer surface, such that ePTFE can eliminate the need or desire for a hydrophilic coating on the outer surface of tube 160. As another example, as described above, the outer surface of layer 306 can be coated with a hydrophilic material to further reduce friction on the outer surface of tube 160.

[0163] For example, with respect to tube 160 having axial and radial ePTFE layers, as shown in FIGS. 7A-7D, it is possible to have axial ePTFE in layer 302 and radial ePTFE in layer 306, or vice versa, or in any two other layers (e.g., in layers 302 and 304, respectively, or in layers 304 and 306, respectively). With respect to tube 160 having axial ePTFE and radial ePTFE, the radial ePTFE can reduce the force required to expand the tube radially, and the axial ePTFE can reduce the force required to expand the tube axially, whereby the radial ePTFE can resist axial expansion of tube 160 as a device (e.g., 329) is advanced along lumen 104, and whereby the axial ePTFE can resist radial expansion of tube 160 as a device (e.g., device 329) is advanced along lumen 104. For a tube 160 having both axial and radial ePTFE layers, for example, a tube 160 having axial ePTFE in layer 302 and radial ePTFE in layer 306, or vice versa, the tube 160 may thereby be easier to expand radially than if both layers 302 and 306 comprise axial ePTFE, and the tube 160 may thereby be easier to expand axially than if both layers 302 and 306 comprise radial ePTFE.

[0164] With respect to tube 160 having a radial ePTFE layer, as well as with respect to tube 160 having an axial ePTFE layer and a radial ePTFE layer, for example, having axial ePTFE in layer 302 and radial ePTFE in layer 306, or vice versa, or with respect to tube 160 having axial ePTFE and radial ePTFE in any two other layers (e.g., in layers 302 and 304, respectively, or in layers 304 and 306, respectively), the radial ePTFE can inhibit or prevent axial elongation of tube 160 when a device (e.g., device 329) is advanced along lumen 104, which can eliminate the need or desire for a reinforcement (e.g., reinforcement 310) to inhibit or prevent axial elongation of tube 160 when a device (e.g., device 329) is passed through tube 160 within lumen 104. This can allow a device having a larger diameter than tube 160 to be advanced along lumen 104 without a reinforcement 310 in the wall of tube 160. As the device is advanced along lumen 104, the radial ePTFE can allow the device to cause radial expansion of tube 160, but can inhibit or prevent the device from expanding tube 160 in the axial direction. Because the radial ePTFE can inhibit axial expansion of tube 160 but allow radial expansion, the radial ePTFE can eliminate the need or desire for a reinforcement 310 (e.g., a braid or spiral wrap) in one of the layers (e.g., layer 302, layer 304, or layer 306).In other words, the radial ePTFE in tube 160 (e.g., in layer 302 and / or in layer 306, as shown in FIGS. 7A-7D ) can inhibit or prevent a device being advanced through lumen 104 from pushing the portion of tube 160 distal to the tip of the device away from the portion of tube 160 proximal to the tip of the device, which can limit or prevent axial elongation of tube 160 as it expands radially. The radial ePTFE in tube 160 can thereby reduce the axial force exerted by tube 160 against the blood vessel during insertion and withdrawal of a device (e.g., device 329) from lumen 104, for example, by reducing or eliminating axial expansion and contraction of tube 160 as a device is advanced into and withdrawn from tube 160. This, in turn, can reduce or eliminate axial tension and / or axial compression of the blood vessel caused by tube 160. Reducing or eliminating axial tension and / or axial compression of the blood vessel can reduce the risk of tube 160 causing embolism when a device (e.g., device 329) is advanced into and withdrawn from lumen 104.

[0165] For example, the radial ePTFE layers (e.g., layers 302, 304, and / or 306) in the first and second variations of material can resist axial tension as tube 160 radially expands when a device is advanced longitudinally through lumen 104. For example, the radial ePTFE can limit the axial expansion of tube 160 as it radially expands (e.g., from diameter d1 to diameter d2) when a device is advanced along lumen 104. The radial ePTFE can, for example, allow tube 160 to axially expand up to the axial expansion limit of the radial ePTFE as a device is advanced along lumen 104, but inhibit or prevent further axial expansion beyond the axial expansion limit. The axial expansion limit of the radial ePTFE can be less than the axial expansion limit of the axial ePTFE. In other words, radial ePTFE can limit axial expansion more than axial ePTFE. Allowing radial ePTFE to expand axially, e.g., up to an axial expansion limit, as opposed to completely preventing axial expansion of the radial ePTFE, can reduce the risk of the inner layer (e.g., layer 302) being torn or punctured by a device as it is advanced axially through lumen 104, and can eliminate the need or desire for reinforcement 310. As another example, radial ePTFE layers (e.g., layer 302 and / or layer 306) can prevent axial expansion of tube 160 as it is radially expanded by a device. While radial ePTFE can eliminate the need or desire for reinforcement 310, as another example, reinforcement 310 (e.g., a braid or spiral wrap) can be embedded within one of the layers (e.g., layer 302, layer 304, or layer 306).In such cases, the reinforcement 310 may transmit torque, reduce or prevent axial expansion of the tube 160 that would otherwise be tolerated by the radial and / or axial ePTFE within the tube 160, and reduce the loads placed on the radial and / or axial ePTFE within the tube 160. The reinforcement 310 may thereby reduce or eliminate axial stretchability of the tube 160, or may assist the radial ePTFE in reducing or eliminating axial stretchability of the tube 160.

[0166] For tube 160 having radial ePTFE in layer 302, the radial ePTFE can reduce or prevent wrinkles and / or folds from forming when tube 160 radially contracts, e.g., from a radially expanded state (e.g., FIG. 7B ), such as from diameter d2 to diameter d1, to an unexpanded state (e.g., FIG. 7A ), as the device is withdrawn from lumen 104. For example, relative to axial ePTFE in layer 302, radial ePTFE in layer 302 can reduce wrinkles and / or folds from forming or can reduce the size and / or number of wrinkles and / or folds that form when tube 160 radially contracts from a radially expanded state (e.g., from diameter d2 to diameter d1).

[0167] For tube 160 having axial ePTFE in both layers 302 and 306, tube 160 may expand axially as the device is advanced along lumen 104, for example, if tube 160 does not have reinforcement 310. As another example, Figures 10A-12H show that tube 160 may have reinforcement 310 that may prevent axial expansion and / or may limit axial expansion of tube 160 up to the axial expansion limit of reinforcement 310.

[0168] For tube 160 having radial ePTFE in both layers 302 and 306, tube 160 can expand radially as the device is advanced along lumen 104, but the radial ePTFE can inhibit or prevent axial expansion of tube 160. As another example, the radial ePTFE in layers 302 and 306 can limit axial expansion of tube 160 to the axial expansion limit of reinforcement 310.

[0169] The ePTFE in layer 302 and / or layer 306 (e.g., axial ePTFE or radial ePTFE) can strengthen tube 160 by increasing the overall thickness (e.g., thickness T1) of tube 160, as opposed to having only layers 302 and 304 or only layers 304 and 306 in FIGS. 7A-7D , which can be other variations of tube 160. The ePTFE in layer 302 can provide tube 160 with a low-friction inner surface, such that the ePTFE can eliminate the need or desire for a hydrophilic coating on the inner surface of tube 160. For example, the ePTFE can have a lower coefficient of friction than the coefficient of friction of the fluoroelastomer in layer 304. As another example, layer 302 can have a hydrophilic inner coating to further reduce friction on the inner surface of tube 160, although the ePTFE can eliminate the need or desire for a hydrophilic inner coating.

[0170] The ePTFE in layer 306 can provide tube 160 with a low-friction outer surface, such that the ePTFE can eliminate the need or desire for a hydrophilic coating on the outer surface of tube 160. For example, the ePTFE can have a lower coefficient of friction than the coefficient of friction of the fluoroelastomer in layer 304. As another example, while the ePTFE can eliminate the need or desire for a hydrophilic outer coating, layer 306 can have a hydrophilic outer coating to further reduce friction on the outer surface of tube 160.

[0171] In a third variation of materials for tube 160 in Figures 7A-7D, one of the layers can include ePTFE and two of the layers can include a fluoroelastomer. For example, Figures 7A-7D show that layer 302 can include ePTFE, layer 304 can include a fluoroelastomer, and layer 306 can include a fluoroelastomer. The ePTFE in layer 302 can be radial and / or axial ePTFE, depending on the direction of desired stretch (e.g., radial ePTFE when a radially expandable tube is desired and axial ePTFE when an axially expandable tube is desired). The fluoroelastomer in layer 304 can be the same as or different from the fluoroelastomer in layer 306. The fluoroelastomer may have a higher coefficient of friction than the ePTFE in layer 302, such that coating 314, shown in Figures 7A-7D on the outer surface of the fluoroelastomer in layer 306, may be beneficial to reduce the coefficient of friction on the outer surface of tube 160. Coating 314 may be, for example, a hydrophilic coating. As another example, tube 160 may not have coating 314.

[0172] 7A-7D show that the liner can include layer 302 and the jacket can include layers 304 and / or 306. The thickness and functionality of the liner and jacket can depend on the material in the wall of tube 160. For example, with respect to a first material variation in which layer 302 includes PTFE, because PTFE is less elastic than ePTFE, layer 302 can be thinner than layer 306, allowing layer 302 to provide lubricity without unduly restricting the elastic properties of the ePTFE in layer 306. The PTFE layer can thereby provide lubricity and resist tearing or puncture by oversized devices as the device is advanced through lumen 104.

[0173] Figure 7A shows tube 160 in an unexpanded state prior to expansion. For example, Figure 7A shows reinforcement 308 in an unexpanded state. The unexpanded state can be a neutral state or a contracted state.

[0174] FIG. 7B shows the tube 160 in an expanded state after expansion. The expanded state in FIG. 7B can be a partially expanded state or a fully expanded state. For example, FIG. 7B shows the reinforcement body 308 in an expanded state. In a first example, FIG. 7B shows the reinforcement body 308 in a partially expanded state. The reinforcement body 308 can be considered to be in a fully expanded state, for example, when the angle 345 between adjacent arms 344a is close to 180 degrees, such as between 170 degrees and 180 degrees. In a second example, FIG. 7B shows the reinforcement body 308 in a fully expanded state.

[0175] 7A and 7B show portions of tube 160 as transparent for illustrative purposes, such that the layered arrangement of tube 160 may be more easily visualized, and so that reinforcement 308 within tube 160 may be more easily visualized. For example, FIGS. 7A and 7B show layers 304 and 306 as transparent. FIGS. 7B and 7D show device 329 as transparent for illustrative purposes, so that tube 160 and its various features may be more easily seen.

[0176] 7A and 7B show that the reinforcement 308 can extend spirally around the lumen 104 when the tube 160 is in an unexpanded state (e.g., FIG. 7A) and when the tube 160 is in an expanded state (e.g., FIG. 7B).

[0177] 7C and 7D show example cross sections of tube 160. Figures 7C and 7D illustrate that, for example, when peak 344p is within valley 344v, the cross section of tube 160 can pass through multiple turns 308t. For example, the cross sections shown in Figures 7C and 7D, taken along lines 7C-7C and 7D-7D in Figures 7A and 7B, respectively, illustrate that lines 7C-7C and 7D-7D can pass through multiple turns 308t, e.g., first turn 308t1, second turn 308t2, and third turn 308t3. The first turn 308t can be adjacent to the second turn 308t2, the second turn 308t2 can be adjacent to the third turn 308t3, and the second turn 308t2 can be between the first turn 308t1 and the second turn 308t2. The first turn 308t1, the second turn 308t2, and the third turn 308t3 can be three consecutive turns 308t of the reinforcement 308. Figures 7A to 7D show that line 7C-7C and line 7D-7D can pass through peak portion 344p (e.g., first peak portion 344p1) of the first turn 308t1, line 7C-7C and line 7D-7D can pass through arm 344a of the second turn 308t2, and line 7C-7C and line 7D-7D can pass through peak portion 344p (e.g., second peak portion 344p2) of the third turn 308t3. In Figures 7C and 7D, the hollow circle in the layer 304 may be the peak portion 344p (e.g., the first peak portion 344p1) of the first turn 308t1, the solid circle in the layer 304 may be the arm 344a of the second turn 308t2, and the circle with hatching or X-shaped hatching may be the peak portion 344p (e.g., the second peak portion 344p2) of the third turn 308t3.7C and 7D, the spaces between the circles (i.e., between the reinforcements 308) in the layer 304 can be valleys 344v, such as first valley 3441 and second valley 344v2 through which lines 7C-7C and 7D-7D pass in Figures 7A and 7B, respectively. For example, the spaces shown adjacent to the hollow circles in the layer 304 in Figures 7C and 7D can be second valleys 344v2, and the spaces shown adjacent to the hatched circles in the layer 304 in Figures 7C and 7D can be first valleys 344v1.

[0178] 7A and 7C illustrate that when tube 160 is in an unexpanded state, tube 160 can have the arrangement of features shown. For example, Figures 7A and 7C illustrate that when tube 160 is in an unexpanded state, lumen 104, layer 302, layer 304, layer 306, and reinforcement 308 can have the arrangement shown, including the relative positions between these features.

[0179] Figures 7B and 7D show that when tube 160 is in the expanded state, tube 160 can have the arrangement of features shown. For example, Figures 7B and 7D show that when tube 160 is in the expanded state, lumen 104, layer 302, layer 304, layer 306, and reinforcement 308 can have the arrangement shown, including the relative positions between these features.

[0180] 7C and 7D show that tube 160 can have a circular cross-section when tube 160 is in an unexpanded state (e.g., FIG. 7C) and when tube 160 is in an expanded state (e.g., FIG. 7D). 7C and 7D show that layers 302, 304, and 306 can have circular cross-sections when tube 160 is in an unexpanded state (e.g., FIG. 7C) and when tube 160 is in an expanded state (e.g., FIG. 7D).

[0181] 7C and 7D show that the reinforcement 308 can be between the inner and outer surfaces of the intermediate layer (e.g., layer 304) when the tube 160 is in an unexpanded state (e.g., FIG. 7C) and when the tube 160 is in an expanded state (e.g., FIG. 7D).

[0182] 7C and 7D show that when tube 160 is in an unexpanded state (e.g., FIG. 7C) and when tube 160 is in an expanded state (e.g., FIG. 7D), reinforcement 308 can be between the outer surface of the inner layer (e.g., layer 302) and the inner surface of the outer layer (e.g., layer 306).

[0183] 7C and 7D show that when tube 160 is in an unexpanded state (e.g., FIG. 7C) and when tube 160 is in an expanded state (e.g., FIG. 7D), layer 302, layer 304, reinforcement 308, and layer 306 can have the concentric arrangement shown in FIGS. 7C and 7D.

[0184] 7C and 7D show that the reinforcement 308 can be at a uniform distance from the lumen 104 when the tube 160 is in an unexpanded state (e.g., FIG. 7C) and when the tube 160 is in an expanded state (e.g., FIG. 7D).

[0185] 7A-7D show that layer 302 can be free of folds when tube 160 is in an unexpanded state (e.g., FIG. 7C) and when tube 160 is in an expanded state (e.g., FIG. 7D). This can reduce friction against the device in lumen 104 and can reduce friction between tube 160 and the vessel wall. As another example, layer 302 can have folds when tube 160 is in an unexpanded state (e.g., FIGS. 7A and 7C) and / or when tube 160 is in an expanded state (e.g., FIGS. 7B and 7D).

[0186] 7A-7D show that the wall of tube 160 can have a thickness T, e.g., thickness T1 and thickness T2. FIG. 7C shows that tube 160 can have thickness T1 (also referred to as first thickness T1) when tube 160 is in an unexpanded configuration, and FIG. 7D shows that tube 160 can have thickness T2 (also referred to as second thickness T2) when tube 160 is in an expanded configuration. First thickness T1 can be equal to or less than second thickness T2. One or more layers of tube 160 can have different thicknesses, e.g., as measured along straight axes, e.g., radial axes, extending perpendicularly from the longitudinal axis of tube 160 (e.g., central longitudinal axis Ax of tube 160). The layers can have the same or different thicknesses from one another. For example, layer 302 can be 0.001 to 0.005 inches thick, layer 304 can be 0.004 to 0.020 inches thick, and layer 306 can be 0.004 to 0.020 inches thick, such that when tube 160 is in an unexpanded state, the wall thickness T1 of tube 160 can have a total thickness of 0.009 to 0.045 inches, excluding the thickness of the inner and / or outer coatings. The thickness of each layer can depend on the combination of materials in the wall of tube 160. Thickness T2 can be the same as or substantially the same as thickness T1. Thickness T2 can be considered substantially the same as thickness T1 if, for example, thickness T2 is within 0.005 inches of thickness T1. For example, Figures 7A-7D show that thickness T1 can be 0.040 inches to 0.050 inches, and that thickness T2 can be 0.040 inches to 0.050 inches (e.g., the same as thickness T1) or can be 0.035 inches to 0.055 inches (e.g., substantially the same as thickness T1).As another example, thickness T2 can be 0.005 inches to 0.100 inches less than thickness T1, including 0.001 inch increments within this range (e.g., 0.005 inches, 0.040 inches, 0.080 inches, 0.100 inches).

[0187] 7A and 7C show that tube 160 can have a diameter d1 (also referred to as first diameter d1) when tube 160 is in a relaxed or unexpanded configuration, and FIGS. 7B and 7D show that tube 160 can have a diameter d2 (also referred to as second diameter d2) when tube 160 is in an expanded configuration (e.g., a partially expanded or fully expanded configuration). FIGS. 7A and 7C show that first diameter d1 can be, for example, from about 5 mm to about 30 mm, including 1 mm increments within this range, and FIGS. 7B and 7D show that second diameter d2 can be, for example, from about 5 mm to about 35 mm, including 1 mm increments within this range. The difference between the first diameter d1 and the second diameter d2 can be the width (e.g., diameter) of a device (e.g., device 329) inserted into and withdrawn from the lumen 104. The difference between the first diameter d1 and the second diameter d2 can be, for example, 0 mm to 30 mm, including 1 mm increments within this range (e.g., 0 mm, 10 mm, 20 mm, 30 mm). For example, FIGS. 7A-7D show that the second diameter d2 can be twice or approximately twice the first diameter d1 (e.g., the second diameter d2 is 100% larger than the first diameter d1). The difference between the first diameter d1 and the second diameter d2 can be 0.00 mm, for example, if the device advanced through the lumen 104 is smaller than diameter d1.

[0188] 7B and 7D show, for example, that the thickness of the reinforcement 308 can be less than half the thickness T1 and less than half the thickness T2.

[0189] Layers 302, 304, and 306 can be rearranged in any order. For example, the positions of layers 302 and 306 can be interchanged, such that layer 306 can be the innermost layer and layer 302 can be the outermost layer. As another example, layers 304 and 306 can be interchanged, such that layer 304 can be the outermost layer. As yet another example, layers 302 and 304 can be interchanged, such that layer 304 can be the innermost layer. For variations in which layer 304 is the innermost layer, the fluoroelastomer can have a higher coefficient of friction than the PTFE or ePTFE in layer 302, such that an inner coating (e.g., an inner hydrophilic coating) on ​​the inner layer of fluoroelastomer in layer 304 may be beneficial. As yet further examples, layer 302 can be omitted from tube 160, layer 304 can be omitted from tube 160, and / or layer 306 can be omitted from tube 160, such that tube 160 can have any one or two of the layers shown in Figures 7A-7D.

[0190] 7A-7D can extend along any length of tube 160. For example, the design shown in FIGS. 7A-7D can extend along the entire length 160L (e.g., 100% of length 160L) or along any length of tube 160 less than the entire length 160L, including, for example, 1% to 99% of length 160L, including 1% increments within this range (e.g., 1%, 10%, 25%, 50%, 75%, 99%). For example, the feature shown in section 160s1 in FIGS. 7A-7D can continue from proximal end 160p of tube 160 (e.g., from the proximal terminal end of tube 160) to distal end 160d of tube 160 (e.g., to the distal terminal end of tube 160). In other words, tube 160 proximal and distal to section 160s1 can have the features shown in Figures 7A-7D. As another example, proximal end 160p of tube 160 can be the proximal 50% of tube 160, distal end 160d of tube 160 can be the distal 50% of tube 160, distal end 160d of tube 160 can have the design in Figures 7A-7D, and proximal end 160p can have a different design with or without the same or different reinforcements 308.

[0191] 8A-8D show variations of tube 160. For example, FIGS. 8A-8D show tube 160 in FIGS. 7A-7D with a different reinforcement 308 than the reinforcement 308 shown in FIGS. 7A-7D. For example, FIGS. 7A-7D show that reinforcement 308 can have a nested configuration (e.g., when tube 160 is in an unexpanded state and when tube 160 is in an expanded state), while FIGS. 8A-8D show that reinforcement 308 can have a non-nested configuration (e.g., when tube 160 is in an unexpanded state and when tube 160 is in an expanded state). FIG. 8A shows a close-up of tube 160 at section S5 of FIG. 6A, and FIG. 8B shows a close-up of tube 160 at section S6 of FIG. 6C. The reinforcement 308 can be considered to have a nested configuration when the peaks 344p are inside the valleys 344v, and the reinforcement 308 can be considered to have a non-nested configuration when the peaks 344p are outside the valleys 344v.

[0192] 8A-8D show that the profile 338 of the reinforcement 308 can define a gap 347 between the peaks 344p and valleys 344v of adjacent turns 308t. The gap 347 can, for example, define a distance 348 between the peaks 344p and valleys 344v, such as between the peaks 344p and valleys 344v of adjacent turns 308t. The distance 348 can, for example, be the length of the gap 347 along an axis parallel to the axis 344x. The gap 347 can, for example, extend helically around the lumen 104. The distance 348 can, for example, be the vertical distance or the distance along the axis 344x between adjacent peaks 344p and valleys 344v.

[0193] 8A and 8B show that when tube 160 is expanded from an unexpanded state to an expanded state, distance 348 can increase from first distance 348a to second distance 348b, and when tube 160 is contracted from an expanded state to an unexpanded state, distance 348 can decrease from second distance 348b to first distance 348a. When tube 160 is in an unexpanded state (e.g., FIG. 8A), first distance 348a can be, for example, 1 mm to 15 mm, including 1 mm increments within this range (e.g., 1 mm, 2 mm, 5 mm, 10 mm, 15 mm). When tube 160 is in an expanded state (e.g., FIG. 8B), second distance 348b can be, for example, 1 mm to 20 mm, including 1 mm increments within this range (e.g., 1 mm, 2 mm, 5 mm, 10 mm, 15 mm, 20 mm). The difference between the second distance 348b when the tube 160 is in an expanded state (e.g., FIG. 8B) compared to the first distance 348a when the tube 160 is in an unexpanded state (e.g., FIG. 8A) can be, for example, 1 mm to 15 mm, including 1 mm increments within this range (e.g., 1 mm, 5 mm, 10 mm, 15 mm). For example, FIGS. 8A and 8B show that the difference between the first distance 348a and the second distance 348b can be 2 mm. When the difference between the first distance 348a and the second distance 348b is 0 mm, the distance 348 does not change when the tube 160 expands and contracts. In other words, the distance 348 may not increase when the tube 160 is expanded. The second distance 348b can be, for example, the same as the first distance 348a.

[0194] 7A-8D show, for example, that adjacent turns 308t of reinforcement 308 may not contact each other when tube 160 is in a straight (e.g., non-curved) unexpanded configuration and when tube 160 is in a straight (e.g., non-curved) expanded configuration.

[0195] 7A-8D, for example, show variations of the reinforcement body 308 having a peak-to-valley configuration, where FIGS. 7A-7D show a nested peak-to-valley configuration and FIGS. 8A-8D show a non-nested peak-to-valley configuration. With respect to the peak-to-valley configuration, the peaks 344p can be aligned with the valleys 344v. FIGS. 7A-8D show, for example, that the reinforcement body 308 can have a profile 338 (e.g., a helical profile) that wraps around the lumen 104 such that a valley 344v can exist between two adjacent peaks 344p. Adjacent peaks 344p can be on adjacent turns 308t. For example, one of the peaks 344p can be on the first turn 308t (e.g., the first turn 308t1 in FIGS. 7A and 7B) and one of the peaks 344p can be on the second turn 308t (e.g., the second turn 308t2 in FIGS. 7A and 7B), such that the valley 344v can be between these two adjacent peaks 344p. For example, FIGS. 7A-8D show that adjacent peaks 344p can exist along the axis 344x, such that the valley 344v can be between adjacent peaks 344p along the axis 344x (e.g., FIGS. 7A and 7B), or such that the valley 344 and the gap 347 can be between adjacent peaks 344p along the axis 344x (e.g., FIGS. 8A and 8B). For example, Figures 7A-8D show that the first peak portion 344p1 can be aligned along the first axis 344x1 and the second valley portion 344v2 can be between adjacent first peak portions 344p1 along the first axis 344x1 (e.g., Figures 7A and 7B), or that the second valley portion 344v2 and the gap 347 can be between adjacent first peak portions 344p1 along the first axis 344x1 (e.g., Figures 8A and 8B).7A-8D illustrate that the second peaks 344p2 can be aligned along the second axis 344x2, and that a first valley 344v1 can be between adjacent second peaks 344p2 along the second axis 344x2 (e.g., FIGS. 7A and 7B), or that a first valley 344v1 and a gap 347 can be between adjacent second peaks 344p2 along the second axis 344x2 (e.g., FIGS. 8A and 8B). The peak-to-valley arrangement in FIGS. 7A-8D can, for example, facilitate bending of the tube 160 more than a peak-to-peak arrangement in which adjacent peaks 344p contact or are otherwise aligned with each other, such that no valleys 344v exist between adjacent peaks 344p.

[0196] Figure 8A shows tube 160 in an unexpanded state prior to expansion. For example, Figure 8A shows reinforcement 308 in an unexpanded state. The unexpanded state can be a neutral state or a contracted state.

[0197] Figure 8B shows the tube 160 in an expanded state after expansion. The expanded state in Figure 8B can be a partially expanded state or a fully expanded state. For example, Figure 8B shows the reinforcement 308 in an expanded state.

[0198] Figures 8A and 8B show portions of tube 160 as transparent for illustrative purposes, such that the layered arrangement of tube 160 may be more easily visualized, and so that reinforcement 308 within tube 160 may be more easily visualized. For example, Figures 8A and 8B show layers 304 and 306 as transparent. Figures 7B and 7D show device 329 as transparent for illustrative purposes, so that tube 160 and its various features may be more easily seen.

[0199] 8A and 8B show that the reinforcement 308 can extend spirally around the lumen 104 when the tube 160 is in an unexpanded state (e.g., FIGS. 8A and 8C) and when the tube 160 is in an expanded state (e.g., FIGS. 8B and 8D).

[0200] Figures 8A and 8C show that when tube 160 is in an unexpanded state, tube 160 can have the arrangement of features shown. For example, Figures 8A and 8C show that when tube 160 is in an unexpanded state, lumen 104, layer 302, layer 304, layer 306, and reinforcement 308 can have the arrangement shown, which can include the relative positions between these features.

[0201] Figures 8B and 8D show that when tube 160 is in the expanded state, tube 160 can have the arrangement of features shown. For example, Figures 8B and 8D show that when tube 160 is in the expanded state, lumen 104, layer 302, layer 304, layer 306, and reinforcement 308 can have the arrangement shown, which can include the relative positions between these features.

[0202] 9A-9H illustrate variations of the tube 160. For example, FIGS. 9A-9H illustrate the tube 160 in FIGS. 7A-7D with a different reinforcement 308 than the reinforcement 308 shown in FIGS. 7A-7D. For example, while FIGS. 7A-7D illustrate that the reinforcement 308 can have a nested peak-to-valley configuration, FIGS. 9A-9H illustrate that the reinforcement 308 can have a peak-to-peak configuration. FIGS. 9A-9H also illustrate that the peak-to-peak configuration of the reinforcement 308 can be a non-nested configuration, in which the peaks 344p (e.g., the apexes of the peaks 344p) of adjacent turns 308t can contact each other. 9A-9H illustrate that the peak-to-peak configuration of reinforcement 308 can be a non-nested, e.g., separated, configuration, in which peaks 344p (e.g., apexes of peaks 344p) of adjacent turns 308t can contact one another. For example, FIG. 9A shows a close-up of tube 160 at section S1 of FIG. 6A, FIG. 9B shows a close-up of tube 160 at section S2 of FIG. 6C, FIGs. 9E and 9F show a close-up of tube 160 at section S3 of FIG. 6B, and FIGs. 9G and 9H show a close-up of tube 160 at section S4 of FIG. 6D.

[0203] 9A-9H illustrate that, for example, the peaks 344p (e.g., peaks 344p facing in opposite directions) of adjacent turns 308t can be adjacent to one another. For example, FIGS. 9A-9H illustrate that the first peak 344p1 and the second peak 344p2 on adjacent turns 308t can be adjacent to one another.

[0204] 9A-9D illustrate that peaks 344p can touch and / or be close to each other (e.g., very close to each other) at point 350, for example, when tube 160 is in a straight, unexpanded configuration (e.g., FIGS. 9A and 9C) and when tube 160 is in a straight, expanded configuration (e.g., FIGS. 9B and 9D). Two peaks 344p (e.g., two adjacent peaks 344p) may be considered to be proximate to one another at point 350 when the distance across the gap 308g between two peaks 344p and / or two turns 308t (e.g., the distance between the apexes of two adjacent peaks 344p) is between 0.0 mm and 1.5 mm, or more narrowly, between 0.0 mm and 0.5 mm, including 0.1 mm increments within these ranges (e.g., 0.0 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1.0 mm, 1.5 mm). A distance of 0.0 mm between two adjacent peaks may indicate that the adjacent peaks 344p are in contact with one another. A distance of 0.0 mm between two adjacent peaks may indicate that the adjacent peaks 344p are in direct contact with one another. A distance of 0.1 mm to 1.5 mm, or more narrowly, a distance of 0.1 mm to 0.5 mm, can indicate that material (e.g., material of layer 302, layer 304, or layer 306) is between two adjacent peaks, but that the two adjacent peaks are close enough to be considered in contact with each other or that force and / or torque can be transferred across point 350. Point 350 can be, for example, a force transfer point and / or a torque transfer point. FIGS. 9A-9D show that peaks 344p can be in contact with each other. For example, FIGS. 9A-9D show that the distance between adjacent peaks 344p can be 0.0 mm.As another example, the peaks 344p may not contact each other when the tube 160 is in a straight, unexpanded configuration and / or when the tube 160 is in a straight, expanded configuration.

[0205] The peaks 344p may be releasably engagable with one another. For example, FIGS. 9A-9H illustrate that the peaks 344p (e.g., peaks 344p facing opposite directions) may move into and out of contact with one another as the tube 160 bends and straightens, e.g., during navigation to and / or from the target site (e.g., a location within a blood vessel). For example, FIGS. 9A-9H illustrate that the first peak 344p1 and the second peak 344p2 may be releasably engagable with one another (e.g., releasably contact one another) on adjacent turns 308t of the reinforcement 308. For example, FIGS. 9A-9H illustrate that the first peak 344p1 may move into and out of contact with the second peak 344p2 on the adjacent turn 308t as the tube 160 bends and straightens during navigation to and / or from the target site.

[0206] 9A-9H illustrate that the reinforcement body 308 can have a profile 338 (e.g., a helical profile) that wraps around the lumen 104 and allows adjacent peaks 344p (e.g., adjacent first and second peaks 344p1 and 344p2) to move in and out of contact with one another. When the peaks 344p are in contact with one another, the contacting peaks 344p can be considered to be releasably engaged with one another. FIGS. 9A-9H illustrate that the peaks 344p of the reinforcement body 308 can contact one another when the tube 160 is in an unexpanded, expanded, straight, and / or curved configuration, for example. FIGS. 9E-9H illustrate that the peaks 344p can move in and out of contact with one another as the tube 160 bends and straightens during navigation to and / or from the target site. For example, Figures 9E-9H show that when tube 160 has a curved configuration, some of the peaks 344p may contact each other (e.g., peaks 344p on the sides of tube 160 in tension), and that when tube 160 has a curved configuration, some of the peaks 344p may not contact each other (e.g., peaks 344p on the sides of tube 160 in compression).

[0207] 9A-9H illustrate that point 350 can be a location where two peaks 344p are in releasable contact with one another. For example, FIGS. 9A-9H illustrate that point 350 can be a location where a first peak 344p1 is in contact with a second peak 344p2. Circles 350c in FIGS. 9A, 9B, and 9F-9H each mark a point 350 where two adjacent peaks 344p (e.g., the first peak 344p1 and the second peak 344p2) on adjacent turns 308t are in contact with one another. Xs in FIGS. 9C and 9D (e.g., in layer 304) each mark a point 350 where two adjacent peaks 344p (e.g., the first peak 344p1 and the second peak 344p2) are in contact with one another. 9A-9H, the turns 308t of the reinforcement 308t are shown with alternating solid and dashed lines so that the turns 308t, the profile 338 (e.g., a helical profile), and the oscillating shape 344 can be more easily seen. In FIGS. 9A-9H, the turns 308t shown with solid lines are between the turns 308t shown with dashed lines, and vice versa. As FIGS. 9A-9H show, when the peaks 344p are in releasable contact with each other, the reinforcement 308 can appear braid-like.

[0208] 9A-9D illustrate exemplary cross sections that may pass through a point 350 where adjacent turns 308t contact each other, for example, at peak portion 344p. For example, the cross sections shown in FIGS. 9C and 9D, taken along lines 9C-9C and 9D-9D in FIGS. 9A and 9B, respectively, illustrate that lines 9C-9C and 9D-9D may pass through point 350 where first turn 308t1 and second turn 308t2 contact each other. The first turn 308t may be adjacent to the second turn 308t2. The first turn 308t1 and second turn 308t2 may be two consecutive turns 308t of the reinforcement 308. 9A-9D show that lines 9C-9C and 9D-9D can pass through or between peaks 344p (e.g., first peak 344p1) of a first turn 308t1 and through or between peaks 344p (e.g., second peak 344p2) of a second turn 308t2. The Xs (e.g., in layer 304) in FIGS. 9C and 9D, respectively, mark points 350 where two adjacent peaks 344p (e.g., first peak 344p1 and second peak 344p2) touch each other. The spaces between Xs in layer 304 in Figures 9C and 9D can be openings to valleys 344v, such as first valley 3441 and second valley 344v2, which pass along lines 9C-9C and 9D-9D in Figures 9A and 9B, respectively. For example, Figures 9A and 9B show that valleys 344v can be adjacent to one another, such that first valley 344v1 can abut second valley 344v2, such that first valley 344v1 and second valley 344v2 can open into one another, and / or such that first valley 344v1 and second valley 344v2 can face one another. Figures 9A and 9B show that when peaks 344p contact one another, there can be no gap between adjacent valleys 344v.As another example, there may be gaps (eg, gap 347) between some of the adjacent valleys 344v.

[0209] 9A-9D illustrate that adjacent peaks 344p can lie along axis 344x, such that first peak 344p1 can releasably contact second peak 344p2. For example, FIGS. 9A-9D illustrate that first peak 344p1 and second peak 344p2 can be aligned along first axis 344x1, such that point 350 can be aligned along first axis 344x1. As another example, FIGS. 9A-9D illustrate that first peak 344p1 and second peak 344p2 can be aligned along second axis 344x2, such that point 350 can be aligned along second axis 344x2. Thereby, points 350 along axes 344x (e.g., first axis 344x1 and second axis 344x2) can extend (e.g., helically) around central longitudinal axis Ax of tube 160. In other words, FIGS. 9A-9D show that points 350 can be aligned with axes 344x, such as, for example, first axis 344x1 and second axis 344x2. FIGS. 9A-9D show that, for example, at point 350, when peaks 344p are in disengageable contact with one another, valleys 344v can be absent along axis 344x.

[0210] 9A-9H illustrate that the peaks 344p can contact one another, such that point 350 can be a point of contact between the ends (e.g., terminal ends, such as apexes) of the peaks 344p. The peaks 344p can be a point where two arms 344a intersect with one another (e.g., for peaks 344p with sharp corners, such as in FIGS. 9A-9H). The peaks 344p can be a point where two arms 344a meet with one another (e.g., for peaks 344p with rounded corners). For example, for peaks 344p with rounded corners, where the point of intersection is less discernible than for sharp corners, the arms 344a can be considered to meet at the apex of the peak 344p. For example, with respect to an oscillating shape 344 having a sinusoidal pattern with rounded corners, the peaks 344p can be the crests and troughs of the sinusoidal pattern of the reinforcement body 308, such that adjacent arms 344a can be considered to meet at the apex of the crests and troughs of the sinusoidal pattern. As another example, the peaks 344p can be flat or planar. FIGS. 9A-9H show that when the peaks 344p contact each other, the arms 344a can not contact each other. As another example, when the peaks 344p contact each other, the arms 344a can contact each other. As another example, because the peaks 344p can be defined by the ends of two arms 344a, FIGS. 9A-9H show that when the peaks 344p contact each other, the ends of the arms 344a can contact the ends of the other arms 344a. In such a case, the portions of the arms 344a between the two ends of the arms 344a may not contact each other, as shown, for example, in Figures 9A-9H.

[0211] 9A-9H show that, for example, at point 350, the peaks 344p can releasably contact each other, but when the peaks 344p are in contact with each other, the peaks 344p can be unconnected to each other. In other words, the peaks 344p can move into and out of contact with each other, such that when the peaks 344p are in contact with each other, adjacent peaks 344p (e.g., adjacent first peak 344p1 and second peak 344p2) can touch each other but not be fixedly connected to each other. This allows the peaks 344p to freely move into and out of contact with each other.

[0212] 9A-9H show that the reinforcement 308 can define cells 352. The cells 352 can have any shape. For example, FIGS. 9A and 9B show that the cells 352 can have a diamond shape when the tube 160 is in a straight, unexpanded configuration, and that the cells 352 can have a diamond shape when the tube is in a straight, expanded configuration.

[0213] 9A-9H show that the arms and peaks 344a, 344p can define boundaries of the cell 352, and that the valleys 344v can define openings in the cell 352. A first end (e.g., a first half) of the cell opening can be the first valley 344v1, and a second end (e.g., a second half) of the cell opening can be the second valley 344v2. For example, the first valley 344v1 can define the first end (e.g., a proximal end) of the cell opening, and the second valley 344v2 can define the second end (e.g., a distal end) of the cell opening. For example, Figures 9A and 9B show that when the first peak portion 344p1 of the first turn 308t1 contacts the second peak portion 344p2 of the second turn 308t2, the cell 352 between the first turn 308t1 and the second turn 308t2 can be defined by the arms 344a and peak portions 344p of the first turn 308t1 and the second turn 308t2, and can also be defined by the valley portion 344v between the first turn 308t1 and the second turn 308t2. 9A and 9B show that the first peak 344p1, the second peak 344p2, and the first valley 344v1 of the first turn 308t1 can define a first end (e.g., a proximal end) of the cell 352 between the first turn 308t1 and the second turn 308t2, and that the first peak 344p1, the second peak 344p2, and the second valley 344v2 of the second turn 308t2 can define a second end (e.g., a distal end) of the cell 352 between the first turn 308t1 and the second turn 308t2. 9A-9H show, for example, that the cell 352 can have four corners, and that the corners of the cell 352 can be points 350. 9A-9H show that the proximal-most and distal-most corners of cell 352 can be aligned with axis 344x, and that the two corners between the proximal-most and distal-most corners of cell 352 can be aligned with other axis 344x.

[0214] 9A-9H illustrate that cells 352 can be openable and closeable, for example, as tube 160 bends and straightens. Cells 352 can open and close, for example, at one or more of the corners of cells 352. For example, FIGS. 9A-9H illustrate that one or more (e.g., two) of the corners of cells 352 can be fixed corners (e.g., closed corners) and that one or more (e.g., two) of the corners of cells 352 can be openable and closeable corners. The fixed corners (e.g., closed corners) can remain closed when the openable and closeable corners open and close.

[0215] FIG. 9A shows tube 160 (eg, section 160s1) in a straight, unexpanded configuration, in which peaks 344p releasably engage each other at points 350. FIG.

[0216] 9B illustrates that when tube 160 (e.g., section 160s1) is expanded, peaks 344p can releasably engage one another at point 350. For example, FIG. 9B illustrates that when tube 160 (e.g., section 160s1) is radially expanded, peaks 344p can contact one another at point 350.

[0217] 9A and 9B show, for example, that peaks 344p can remain in contact with one another when a device (eg, device 329) is advanced into and withdrawn from lumen 104. In the embodiment shown in FIG.

[0218] 9A and 9B illustrate that torque from torsional loads 354a and 354b and / or force from axial loads 356a and 356b can be transferred across point 350, such that point 350 can be a force transfer point and / or torque transfer point. In other words, force and / or torque can be transferred across turn 308t of reinforcement 308, for example, at point 350. Reinforcement 308 can thereby function as a braid or spiral wrap, for example, when adjacent turns 308t of reinforcement 308 contact each other (e.g., at point 350). If the material (e.g., matrix) of tube 160 and / or reinforcement 308 cannot support the load applied to tube 160, peaks 344p can disengage from each other (e.g., break contact with each other), for example, by moving (e.g., translating) relative to each other.

[0219] When the peaks 344p in releasable contact with one another disengage from one another, for example, due to a threshold axial and / or torsional force being exceeded, the contacting peaks 344p can move toward or away from one another. For example, at point 350, the first peak 344p1 can move axially away from the second peak 344p2, the first peak 344p1 can move laterally away from the second peak 344p2, the first peak 344p1 can slide under the second peak 344p2, the first peak 344p1 can slide over the first peak 344p1, and so on. For example, the first peak 344p1 can slide along one of the two arms 344a extending from the second peak 344p2 to a first side of the second peak 344p2, and the first peak 344p1 can slide along the other of the two arms 344a extending from the second peak 344p2 to a second side of the second peak 344p2, and / or vice versa with the second peak 344p2 moving relative to the first peak 344p1. In other words, when the peaks 344p contact each other, the reinforcement 308 can function as a structure with a connection at point 350, but point 350 can provide a break or shear point such that adjacent peaks 344p can move (e.g., translate) relative to each other if the force applied to the tube 160 exceeds a threshold force related to point 350. Therefore, point 350 can be the weakest place to have movement and therefore can provide a release point for reinforcement 308 .This allows the reinforcement 308 to function as a braid or spiral wrap when the peaks 344p are in contact with one another (e.g., at points 350), and thereby to function as a coil having a zigzag shape when the peaks 344p are not in contact with one another (e.g., at points 350).

[0220] 9A and 9B show that when peaks 344p are in releasable contact with one another (e.g., at point 350), reinforcement 308 inhibits or prevents axial expansion of tube 160. In other words, when peaks 344p are in contact with one another (e.g., at point 350), reinforcement 308 can function as reinforcement 310. For example, when a device (e.g., device 329) is advanced through lumen 104, point 350 can inhibit or prevent axial expansion of tube 160, such that peaks 344p can remain in contact with one another at point 350 as the device is advanced through the lumen. For example, distal peak 344p (e.g., second peak 344p2) can press against or resist distal movement of proximal peak 344p (e.g., first peak 344p1) as the device is advanced through the lumen. This can thereby inhibit or prevent axial expansion of tube 160 as it expands radially due to the device being advanced through lumen 104.

[0221] 9A-9H show that the peaks 344p can move relative to one another as the tube 160 bends and straightens, for example, as the tube 160 is navigated to a target site (e.g., within a blood vessel, organ, or digestive tract). For example, when the tube 160 is placed in tension, for example, from a straight configuration to a curved configuration (e.g., to the curved portion 336), the peaks 344p can move away from one another. When the tube 160 returns to a straight configuration or becomes less curved (e.g., from a curved configuration having the curved portion 336), the peaks 344p can move toward one another. As another example, when the tube 160 changes position (e.g., bends or flexes), for example, from the curved portion 336 to another curved portion having a different shape, the peaks 344p can move relative to one another (e.g., toward and away from one another). Points 350 can inhibit or prevent kinking of tube 160 when tube 160 bends. For example, when adjacent peaks 344p contact one another (e.g., at points 350), the contact between peaks 344p can inhibit or prevent kinking of tube 160, for example, when tube 160 is in a curved configuration (e.g., curved portion 336) or when tube 160 transitions from a straight configuration to a curved configuration (e.g., curved portion 336).

[0222] 9A-9D illustrate the relative positions between peaks 344p, for example, when tube 160 is in a straight configuration. As shown in FIGS. 9A-9D, when tube 160 is in a straight configuration, adjacent peaks 344p can be in releasable contact with one another at points 350. As another example, when tube 160 is in a straight configuration, adjacent peaks 344p can be separated by a gap (e.g., a gap of 1 mm to 10 mm) such that when the tube assumes a curved configuration (e.g., the curved configuration shown in FIGS. 6B and 6D), adjacent peaks 344p can move into releasable contact with one another. As yet another example, when the tube 160 is in a straight configuration, adjacent peaks 344p can be separated by gaps 347, such that when the tube assumes a curved configuration (e.g., the curved configurations shown in FIGS. 6B and 6D), adjacent peaks 344p can move into releasable contact with one another. For example, adjacent turns in a peak-to-peak configuration can be separated by gaps 347 or by gaps between turns, as shown, for example, in FIGS. 7A-8D.

[0223] 9E and 9F show the relative positions that peak 344p can have when the tube has an unexpanded curved configuration (e.g., curved portion 336). FIG. 9E shows a compressed section of tube 160, e.g., the radially inner side of curved portion 336 in FIG. 6B (e.g., the bottom portion of curved portion 336 in FIG. 6B), and FIG. 9F shows a tensioned section of tube 160, e.g., the radially outer side of curved portion 336 in FIG. 6B (e.g., the top portion of curved portion 336 in FIG. 6B). In other words, FIGS. 9E and 9F show the compressed and tensioned sides of curved portion 336 in FIG. 6B.

[0224] 9G and 9H show the relative positions that peak 344p can have when the tube has an expanded, curved configuration (e.g., curved portion 336). FIG. 9G shows a compressed section of tube 160, e.g., the radially inner side of curved portion 336 in FIG. 6D (e.g., the bottom portion of curved portion 336 in FIG. 6D), and FIG. 9H shows a tensioned section of tube 160, e.g., the radially outer side of curved portion 336 in FIG. 6D (e.g., the top portion of curved portion 336 in FIG. 6D). In other words, FIGS. 9G and 9H show the compressed and tensioned sides of curved portion 336 in FIG. 6D.

[0225] 9E and 9G show that adjacent peaks 344p can be in releasable contact with one another at point 350 in a compressed portion of tube 160 (e.g., radially inward of curved portion 336 shown in FIGS. 6B and 6D ). Point 350 in a compressed portion of tube 160 (e.g., inward of curved portion 336) can inhibit or prevent tube 160 from kinking in a curved portion, e.g., in the compressed portion of curved portion 336. In other words, peaks 344p (e.g., first peak 344p1 and second peak 344p2 at point 350) in a compressed portion can inhibit or prevent tube 160 from kinking, for example, when tube 160 is in or assumes a curved configuration (e.g., curved portion 336). 9E and 9G show that in compressed sections of tube 160 (eg, radially inward of curved portion 336), cells 352 can close.

[0226] 9F and 9H illustrate that adjacent peaks 344p can disengage from one another in the tensioned portion of the tube 160 (e.g., radially outward of the curved portion 336 shown in FIGS. 6B and 6D). FIGS. 9F and 9H illustrate that when adjacent peaks 344p are disengaged from one another, the peaks 344p in the tensioned portion of the tube 160 that were in releasable contact with one another can be separated from one another by gaps 358. FIGS. 9F and 9H illustrate that the gaps 358 can have different sizes along the length of the tensioned portion of the tube 160. For example, FIGS. 9F and 9H illustrate that the gaps 358 can include a first gap 358a, a second gap 358b, and a third gap 358c, or any combination thereof. The first gap 358a can be at the apex of the curved portion 336 and can be the largest gap 358. The third gap 358c may be the gap 358 farthest from the apex of the curved portion 336 and may be the smallest gap 358. The second gap 358b may be between the first gap 358a and the third gap 358c and may have a size between the sizes of the first gap 358a and the third gap 358c. For example, the gaps 358 may become gradually smaller with increasing distance from the apex of the curved portion 336. The gaps 358 may be between adjacent turns 308t. For example, the first gap 358a is shown in FIG. 9F between the third turn 308t3 and the fourth turn 308t4, the second gap 358b is shown in FIG. 9F between the second turn 308t2 and the third turn 308t3, and the third gap 358c is shown in FIG. 9F between the first turn 308t1 and the second turn 308t2.

[0227] 9F and 9H show that gap 358 can have width 358w (also referred to as gap width 358w). Gap width 358w can be, for example, the distance between adjacent peaks 344p. For example, FIGS. 9F and 9H show that gap width 358w can be measured between first peak 344p1 and second peak 344p2. Width 358w can be less than, equal to, or greater than arm length 344aL; less than, equal to, or greater than distance 344d; and / or less than, equal to, or greater than the diameter of tube 160 (e.g., the diameter of lumen 104) when the tube has curved portion 336, or any combination thereof. 9F and 9H show that width 358w can be smaller than arm length 344aL, can be smaller than distance 344d, and can be smaller than the diameter of tube 160. As another example, all gaps 358 can have the same size (e.g., the same width 358w). As another example, width 358w can be, for example, 0.1 mm to 10.0 mm, or more narrowly, 0.1 mm to 5.0 mm, including 0.1 mm increments within these ranges (e.g., 0.1 mm, 5.0 mm, 10.0 mm). For example, the width 358w of the first gap 358a can be, for example, 6.1 to 8.0 mm, the width 358w of the second gap 358b can be, for example, 4.1 mm to 6.0 mm, and the width 358w of the third gap 358c can be, for example, 2.0 mm to 4.0 mm, including 0.1 mm increments within these ranges.As another example, width 358w of first gap 358a can be, for example, 0.1 mm to 6.0 mm larger than width 358w of second gap 358b, which can be, for example, 0.1 mm to 6.0 mm larger than width 358w of third gap 358c, including 0.1 mm increments within these ranges.

[0228] 9F and 9H show that cells 352 can be open in tensioned sections of tube 160 (e.g., radially outward of curved portion 336). FIGS. 9A, 9B, 9F, and 9H show that cells 352 can be open when reinforcement 308 is in tension. Cells 352 can open and close, for example, at one or more of the corners of cells 352. For example, FIGS. 9F and 9H show that two corners of cell 352 can be open and two corners of cell 352 can be closed when cell 352 is in a tensioned state. For example, FIGS. 9A-9H show that cells 352 can split (e.g., split in half) when open, for example, due to bending, axial expansion, and / or radial expansion of tube 160.

[0229] 9A-9E and 9G illustrate that when the cells 352 are in a closed configuration, the cells 352 can be isolated from one another (e.g., adjacent cells 352 can be unconnected to one another). FIGS. 9F and 9H illustrate that when the cells 352 are in an open configuration, adjacent cells 352 can be connected to one another along one or more cell openings (e.g., open corners of the cells), thereby forming one or more larger cells. For example, as shown in FIGS. 9F and 9H, when the cells 352 are open, the cells 352 can merge with one another to generate a larger cell that can extend partially around the central longitudinal axis Ax (e.g., spirally), e.g., in a crescent-shaped or semicircular ring at the tensioned side of the curved portion 336. For example, FIGS. 9F and 9H illustrate that a first gap 358a can connect two, three, or more cells 352 at the apex of the curved portion 336. 9F and 9H show that gaps 358 (e.g., two first gaps 358a) can connect three cells 352 at the apex of curved portion 336. As another example, FIGS. 9F and 9H show that second gaps 358b can connect two, three, or more cells 352 on one or both sides of the apex of curved portion 336. For example, FIGS. 9F and 9H show that gaps 358 (e.g., two second gaps 358b) can connect three cells 352 proximal to the apex of curved portion 336, and that gaps 358 (e.g., two second gaps 358b) can connect three cells 352 distal to the apex of curved portion 336. As yet another example, Figures 9F and 9H show that a third gap 358c can connect two, three, or more cells 352 on one or both sides of the apex of the curved portion 336.For example, Figures 9F and 9H show that gaps 358 (e.g., two third gaps 358c) can connect three cells 352 proximal to the apex of curved portion 336, and that gaps 358 (e.g., two third gaps 358c) can connect three cells 352 distal to the apex of curved portion 336.

[0230] 9E-9H show that the cells 352 on the compressed side of the curved portion 336 can close and the cells on the tensioned side of the curved portion 336 can open. The separation between the peaks 344p on the tensioned side of the curved portion 336 can act like a spring to resist kinking of the tube, for example, by biasing the tube 160 back to a less curved or straight configuration.

[0231] The cells 352 can be biased to have a closed configuration. In other words, the peaks 344p can be biased to contact each other at the point 350. In such a case, if the tube 160 kinks at a point along the curve (e.g., along the curve 336), the peaks 344p that are disengaged from each other on the tensioned side of the curve 336 can be biased to re-engage each other (e.g., due to the elasticity and / or spring properties of the reinforcement 308), such that the reinforcement 308 radially outward of the kinked portion of the tube 160 can return to, or assist in returning the tube 160 to, an unkinked or less kinked configuration. For example, when the tube 160 is in a kinked configuration, the first and second peaks 344p1 and 344p2 at the tensioned sides of the kinked portion can move toward each other or can be configured to move toward each other to undone or unkink the tube 160. The reinforcer 308 can thereby be configured to return the tube 160 from the kinked configuration to an unkinked or less kinked configuration. When the tube 160 is in a kinked configuration, for example, the disengaged peaks 344p radially outward of the kinked portion can be configured to move toward each other, such that the reinforcer 308 is configured to pull the portions of the tube 160 proximal and distal to the kink toward each other. As another example, the cell 352 can not be biased to have a closed configuration. In other words, the peaks 344p can not be biased to contact each other at the point 350.

[0232] 9A-9H illustrate that peaks 344p can move toward and away from one another as tube 160 bends and straightens, for example, as tube 160 is navigated to and from a target site. 9A-9H illustrate that peaks 344p can engage and disengage from one another as tube 160 bends and straightens. For example, peaks 344p can move toward and away from one another as cells 352 close and open, respectively. The openable and closeable cells 352 can provide the tube 160 with flexibility to bend and straighten as it is navigated to a target site, while providing the tube 160 with rigidity to inhibit or prevent kinking (e.g., via points 350), for example, by limiting the radius of curvature that the curved portion 336 can reach or by limiting, inhibiting, or preventing the radius of curvature of the curved portion 336 from exceeding a threshold radius of curvature. The number of peaks 344p that can contact each other between adjacent turns 308t can be controlled, selected, or otherwise optimized to make the tube 160 more difficult to bend (e.g., by increasing the number of points 350) or easier to bend (e.g., by decreasing the number of points 350). The number of points 350 can be increased, for example, by shortening the distance 344d (e.g., by decreasing the wavelength of the reinforcement body 308 relative to the distance 344d, as shown in Figures 9A-9H).The number of points 350 can be reduced, for example, by increasing the distance 344 (e.g., by increasing the wavelength of the reinforcement 308 relative to the distance 344d, as shown in Figures 9A-9H), and / or by having arms 344a with multiple lengths 344aL, for example, by having every other peak 344p touch each other, every third peak 344p touch each other, or every fourth peak 344p touch each other, rather than every peak 344p as shown in Figures 9A-9D.

[0233] 9A-9H show that when the peaks 344p are in releasable contact with one another (e.g., at point 350), point 350 can function, for example, as a connection between adjacent turns 308t of reinforcement 308. This can enable reinforcement 308 to function, for example, as a first structure (e.g., a braid or spiral wrap) when the peaks 344p are in contact with one another (e.g., when first peak 344p1 and second peak 344p2 are in contact with one another), and as a second structure (e.g., a coil such as a helical wire having a zigzag shape) when the peaks 344p are disengaged from one another (e.g., when first peak 344p1 and second peak 344p2 are disengaged from one another). As another example, this can allow the reinforcement 308 to function as a first structure (e.g., a braid or spiral wrap) and a second structure (e.g., a coil such as a helical wire having a zigzag shape) when the peaks 344p are in contact with each other (e.g., when the first peak 344p1 and the second peak 344p2 are in contact with each other), and as a second structure (e.g., a coil such as a helical wire having a zigzag shape) when the peaks 344p are disengaged from each other (e.g., when the first peak 344p1 and the second peak 344p2 are disengaged from each other). The first structure can include the second structure. The first structure of the reinforcement 308 can include the second structure of the reinforcement 308.The points 350 may thereby enable the reinforcement 308 to function as an interconnected structure, such as a framework having cells 352, a mesh having cells 352, a network of struts (e.g., arms 344a) and cells (e.g., cells 352), a frame having cells 352, a support having cells 352, an interconnected lattice structure having cells 352, or any combination thereof, whereby the interconnected structure may be and / or function as a unitary structure, such as a braid or spiral wrap. The first structure may be, for example, a framework having cells 352, a mesh having cells 352, a network of struts (e.g., arms 344a) and cells (e.g., cells 352), a frame having cells 352, a support having cells 352, an interconnected lattice structure having cells 352, or any combination thereof. The reinforcement 308 may have a primary structure and a secondary structure. For example, the primary structure can be a first structure of the reinforcement 308, and the secondary structure can be a second structure of the reinforcement 308. As another example, the primary structure can be a second structure of the reinforcement 308, and the secondary structure can be a first structure of the reinforcement 308. The reinforcement 308 can thereby function as a coil and / or a braid. The reinforcement 308 can thereby function as a coil and / or a spiral wrap.

[0234] 9A-9H show that adjacent peaks 344p in the straight portion of the tube 160 can remain in contact with one another when the tube 160 is moved from a straight configuration (e.g., the straight configuration in FIGS. 6A and 6C) to a curved configuration (e.g., the curved configuration in FIGS. 6B and 6D). Compression at the radially inner side of the curved portion (e.g., curved portion 336) can push the peaks 344p that are in contact with one another in the straight configuration further into one another, as shown by compression arrows C in FIGS. 9E and 9G. As FIGS. 9E and 9G show, the contact between the peaks 344p can permit but resist bending of the tube, such that the peaks 344p that are in contact with one another in the compressed portion of the tube 160 (e.g., point 350 in FIGS. 9E and 9G) can inhibit or prevent the tube 160 from kinking. Tension on the radially outward side of a curved portion (e.g., curved portion 336) can disengage peaks 344p that are in contact with each other in a straight configuration, as shown by tension arrows T in FIGS. 9F and 9H. FIGS. 9A-9H illustrate, for example, that reinforcement 308 can function differently when in compression and tension. When in tension, reinforcement 308 can function as a second structure (e.g., a coil such as a zigzag wire that extends helically around lumen 104). When in compression, reinforcement 308 can function as a first structure (e.g., an interconnected structure including, for example, a braid or spiral wrap). For example, when tube 160 is in tension radially outside a curve (e.g., curve 336), reinforcement 308 can function as an elongated member (e.g., a wire) having a vibrating shape 344, and when tube 160 is in compression radially inside a curve (e.g., curve 336), reinforcement 308 can function as an interconnected structure (e.g., a braid or spiral wrap) with points 350.As another example, when in compression, the reinforcement 308 can function as a first structure and a second structure. For example, when the tube 160 is in tension radially outside a curve (e.g., curve 336), the reinforcement 308 can function as an elongated member (e.g., a wire) having an oscillating shape 344, and when the tube 160 is in compression, for example, radially inside a curve (e.g., curve 336), the reinforcement 308 can function as an elongated member (e.g., a wire) having an oscillating shape 344 and as an interconnected structure (e.g., a braid or spiral wrap) with points 350. As described above, the interconnected structure can be, for example, a framework having cells 352, a mesh having cells 352, a network of struts (e.g., arms 344a) and cells (e.g., cells 352), a frame having cells 352, a support having cells 352, an interconnected lattice structure having cells 352, or any combination thereof, whereby the interconnected structure can be and / or function as one or more structures, such as a coil and / or a braid or spiral wrap. A first portion of the reinforcer 308 can function as a first structure (e.g., a coil), while a second portion of the reinforcer 308 can function as a second structure (e.g., a braid or spiral wrap). For example, a portion of the reinforcer 308 in tension can function as a coil, while a portion of the reinforcer 308 in compression can function as a braid or spiral wrap. The first structure and the second structure can be formed sequentially and / or simultaneously in different portions of the reinforcement 308.For example, Figures 9A and 9B show that the reinforcement 308 can form and / or function as a first and / or second structure when the tube 160 is in a straight configuration, Figures 9E and 9G show that the reinforcement 308 can form and / or function as a first and / or second structure in a compressed portion of the tube 160, and Figures 9F and 9H show that the reinforcement 308 can form and / or function as a second structure in a tensioned portion of the tube 160. The first structure can include the second structure. The first structure of the reinforcement 308 can include the second structure of the reinforcement 308. As yet another example, the reinforcement 308 can function similarly when in compression and when in tension (e.g., when the tube 160 is in a straight configuration, when adjacent turns of the reinforcement 308 are not in contact with each other, and when the tube 160 has a curved configuration).

[0235] As another example, when tube 160 is bent or assumes a curved configuration (e.g., curved portion 336), peaks 344p can move from not contacting one another to being in releasable contact with one another. For example, as shown in FIGS. 9A-9D, when tube 160 is in a straight configuration, peaks 344p on adjacent turns 308t can be out of releasable contact with one another and can move into contact with one another, as shown in FIGS. 9E and 9G. As another example, tube 160 can be moved from a first curved configuration to a second curved configuration. The first curved configuration can be, for example, curved portion 336 shown in FIGS. 6B and 6D. The second curved configuration can be, for example, a curved section having the opposite shape but the same radius of curvature as curved section 336 shown in Figures 6B and 6D (i.e., a curved section with a tip that is bent upward instead of downward as shown in Figures 6B and 6D). In such a case, the tensioned and compressed portions of the curved section of the second curved configuration can be on opposite sides of tube 160 from those shown in Figures 9E-9H (i.e., rather than the bottom of the curved section being in compression and the top of the curved section being in tension as shown for curved section 336, the top of the curved section can be in compression and the bottom of the curved section can be in tension for the curved section of the second configuration).In other words, for the first curved configuration, FIG. 9E can show a bottom compressed section of curved portion 336, FIG. 9F can show a top tensioned section of curved portion 336, FIG. 9G can show a bottom compressed section of curved portion 336, and FIG. 9H can show a top tensioned section of curved portion 336; for the second curved configuration, FIG. 9E can show a top compressed section of the curved portion in the second curved configuration, FIG. 9F can show a bottom tensioned section of the curved portion in the second curved configuration, and FIG. 9G shows a top compressed section of the curved portion in the second curved configuration. 9H can show the tensioned section of the bottom of the curved portion of the second curved configuration, whereby the peaks 344p that are not touching each other in the tensioned portion of the first curved configuration (e.g., the radially outer side of the curved portion 336, or the tensioned upper portion of the curved portion 336 as shown in FIGS. 9F and 9H) can move to touch each other, such that they touch each other at point 350 in the compressed portion of the second curved configuration (e.g., the radially inner side of the curved portion, or the compressed upper portion of the curved portion as shown in FIGS. 9E and 9G for the second curved configuration). As yet another example, with respect to a variation in which the peaks 344p do not contact each other when the tube 160 is in a straight configuration (e.g., with respect to a peak-to-peak variation in which the peaks 344p do not contact each other when the tube 160 is straight), the peaks 344p can move to be in releasable contact with each other in compressed sections of the curved portion 336 (e.g., radially inward of the curved portion) when the tube 160 assumes the shape of the curved portion 336, and can move farther apart in tensioned sections of the curved portion 336 (e.g., radially outward of the curved portion) when the tube 160 assumes the shape of the curved portion 336.The peaks 344p are able to move in and out of contact with one another as the tube 160 bends and straightens.

[0236] 9A-9E and 9G illustrate that when the peaks 344p are in contact with one another (e.g., at point 350), the contacting peaks 344p can move away from one another, for example, due to bending, axial expansion, and / or radial expansion of the tube 160. FIGS. 9F and 9H illustrate that when the peaks 344p are separated from one another (e.g., disengaged from one another), for example, by gaps 347 and / or gaps between turns 308t, as shown, for example, in FIGS. 7A-8D, the separated peaks 344p can move toward one another, for example, due to bending, axial contraction, and / or radial contraction of the tube 160. The reinforcement 308 can thereby be an openable and closeable structure. The openable and closeable structure can be, for example, an interconnected structure. The openable and closeable structure can be, for example, a framework having cells 352, a mesh having cells 352, a network of struts (e.g., arms 344a) and cells (e.g., cells 352), a frame having cells 352, a support having cells 352, an interconnected lattice structure having cells 352, or any combination thereof, whereby the openable and closeable structure can be and / or function as a first structure (e.g., a braid or spiral wrap) and / or a second structure (e.g., a coil). For example, reinforcement 308 can form a first structure or a first structure and a second structure when in the closed configuration, and can form a second structure when in the open configuration.For example, when the peak portions 344p of adjacent turns 308t are in releasable contact at point 350, the reinforcement 308 can function both as a helical structure (e.g., a wire) in which adjacent turns 308t are in contact with each other, and as an interconnected structure (e.g., a braid or spiral wrap) in which adjacent turns 308t are in contact with each other, and thereby, when the peak portions 344p are separated from each other (e.g., from point 350), the reinforcement 308 can function as a helical structure (e.g., a wire) in which adjacent turns 308t are not in contact with each other. As another example, when the peaks 344p of adjacent turns 308t are in releasable contact at point 350, the reinforcer 308 can function both as a first structure in which adjacent turns 308t are in contact with one another (e.g., a braid or spiral wrap) and as a second structure in which adjacent turns 308t are in contact with one another (e.g., a coil), such that when the peaks 344p are separated from one another (e.g., from point 350), the reinforcer 308 can function as a second structure in which adjacent turns 308t are not in contact with one another (e.g., a coil). In contrast to a braid or spiral wrap, which may have cells that are always closed, FIGS. 9A-9H show that the reinforcer 308 can have openable and closeable cells 352, for example, by bending, axially expanding, axially contracting, radially expanding, and / or radially contracting the tube 160.

[0237] 9E-9H thereby illustrate that, for example, a peak-to-peak arrangement of the reinforcement 308, such as the peak-to-peak arrangement shown in FIGS. 9A-9H, can inhibit or prevent kinking of the tube 160 when the tube 160 assumes a curved configuration and / or when the tube is in a curved configuration.

[0238] Figures 9A, 9C, 9E, and 9F show tube 160 in an unexpanded state prior to expansion. For example, Figures 9A, 9C, 9E, and 9F show stiffener 308 in an unexpanded state. The unexpanded state of tube 160 and / or stiffener 308 can be a neutral or contracted state of tube 160 and / or stiffener 308.

[0239] Figures 9B, 9D, 9G, and 9H show tube 160 in an expanded state after expansion. The expanded state in Figures 9B, 9D, 9G, and 9H can be a partially expanded state or a fully expanded state. For example, Figures 9B, 9D, 9G, and 9H show reinforcement body 308 in an expanded state.

[0240] 9A, 9B, and 9E-9G depict portions of tube 160 as transparent for illustrative purposes, e.g., so that the layered arrangement of tube 160 may be more easily visualized and so that reinforcement 308 within tube 160 may be more easily visualized. As a first example, FIGS. 9A, 9B, and 9E-9G depict a front portion (e.g., the front half) of tube 160 and a rear portion (e.g., the rear half) of reinforcement 308 as transparent, whereby the portion of reinforcement 308 that is visible may be the portion of reinforcement 308 in the front half of tube 160. As a second example, FIGS. 9A, 9B, and 9E-9G depict a front portion (e.g., the front half) of tube 160 and a front portion (e.g., the front half) of reinforcement 308 as transparent, whereby the portion of reinforcement 308 that is visible is the portion of reinforcement 308 in the rear half of tube 160. 9B, 9D, 9F, and 9G show device 329 as transparent for illustrative purposes so that tube 160 and its various features can be more easily seen. For example, device 329 can be in contact with the inner wall of layer 302.

[0241] 9A-9H show that the reinforcement 308 can extend spirally around the lumen 104 when the tube 160 is in an unexpanded state (e.g., FIGS. 9A, 9C, 9E, and 9F) and when the tube 160 is in an expanded state (e.g., FIGS. 9B, 9D, 9G, and 9H).

[0242] Figures 9A, 9C, 9E, and 9F illustrate that when tube 160 is in an unexpanded state, tube 160 can have the arrangements of features shown. For example, Figures 9A, 9C, 9E, and 9F illustrate that when tube 160 is in an unexpanded state, lumen 104, layer 302, layer 304, layer 306, and reinforcement 308 can have the arrangements shown, including the relative positions among these features.

[0243] Figures 9B, 9D, 9G, and 9H illustrate that when tube 160 is in the expanded state, tube 160 can have the arrangements of the features shown. For example, Figures 9B, 9D, 9G, and 9H illustrate that when tube 160 is in the expanded state, lumen 104, layer 302, layer 304, layer 306, and reinforcement 308 can have the arrangements shown, which include the relative positions between these features.

[0244] The tube 160 can have a reinforcement 310 (e.g., a braid or a spiral wrap). For example, Figures 10A-18H show that the tube 160 can have a reinforcement 310.

[0245] Reinforcement 310 can provide the benefits described herein. Reinforcement 310 can, for example, allow, limit, inhibit, and / or prevent axial expansion of tube 160. For example, reinforcement 310 can allow, limit, inhibit, and / or prevent axial expansion of tube 160 when tube 160 is subjected to a pulling force as a device (e.g., device 329) is advanced through lumen 104. For example, when the wall of tube 160 has an axially stretchable layer (e.g., a layer having axial ePTFE), reinforcement 310 can allow, limit, inhibit, and / or prevent axial expansion of tube 160 when a device (e.g., device 329) is advanced through lumen 104. Because axial ePTFE is capable of axial stretching when tensioned, reinforcement 310 can be used to allow, limit, inhibit, and / or prevent such axial stretching of tube 160 during advancement of a device (e.g., device 329) along lumen 104 when a layer (e.g., layer 302, layer 304, and / or layer 306) of tube 160 comprises ePTFE (e.g., axial ePTFE). As another example, reinforcement 310 can transmit torque, for example, when tube 160 is rotated in directions 353a and 353b. FIGS. 10A-18H show that both reinforcement 308 and reinforcement 310 can transmit torque, for example, when tube 160 is rotated in directions 353a and / or 353b.

[0246] Reinforcement body 310 can be in (e.g., embedded in) layer 302, layer 304, or layer 306. For example, Figures 10A-12H show that reinforcement body 310 can be in (e.g., embedded in) layer 306. As an additional example, Figures 13A-18H show that reinforcement body 310 can be in (e.g., embedded in) layer 304.

[0247] Reinforcement 310 can be in the same layer as reinforcement 308 or in a different layer than reinforcement 308. For example, FIGS. 10A-12H show that reinforcement 310 can be in a different layer than reinforcement 308. For example, FIGS. 10A-12H show that reinforcement 308 can be in layer 304 and reinforcement 310 can be in layer 306, or vice versa (e.g., reinforcement 310 can be in layer 304 and reinforcement 308 can be in layer 306). As another example, reinforcement 310 can be in the same layer as reinforcement 308. For example, reinforcement 308 and reinforcement 310 can both be in layer 302, both be in layer 304, or both be in layer 306. When reinforcement body 308 and reinforcement body 310 are in the same layer, reinforcement body 308 can be closer to lumen 104 than reinforcement body 310, or vice versa. For example, Figures 13A-18H show exemplary variations in which reinforcement body 308 and reinforcement body 310 are both in layer 304. Figures 13A-18H show, for example, that reinforcement body 308 and reinforcement body 310 can be in a single layer (e.g., layer 304) of the wall of tube 160.

[0248] Reinforcement body 310 can extend partially or completely around reinforcement body 308, or vice versa. For example, Figures 10A-18H show that reinforcement body 310 can extend completely around reinforcement body 308. For example, Figures 10A-18H show that reinforcement body 308 can be surrounded by reinforcement body 310, or vice versa.

[0249] Reinforcement body 308 can be closer to lumen 104 than reinforcement body 310, or vice versa. For example, FIGS. 10A-18H show that reinforcement body 308 can be closer to lumen 104 than reinforcement body 310. FIGS. 10A-18H show that, for example, when tube 160 is in an unexpanded state (see, e.g., FIGS. 10A-18H ), and when tube 160 is in an expanded state (see, e.g., FIGS. 10A-18H ), a majority of reinforcement body 308 (e.g., including 51% to 100% of reinforcement body 308, or more narrowly, including 90% to 100% of reinforcement body 308, which includes, e.g., 100% of reinforcement body 308) can be closer to lumen 104 than reinforcement body 310. As another example, Figures 10A-18H show that reinforcement 310 can extend (e.g., circumferentially) around reinforcement 308 when tube 160 is in an unexpanded state (see, e.g., Figures 10A-18H) and when tube 160 is in an expanded state (see, e.g., Figures 10A-18H).

[0250] As an additional example, the positions (e.g., radial positions) of reinforcement 308 and reinforcement 310 in Figures 10A-18H can be interchanged. For example, with respect to Figures 10A-12H, the positions of reinforcement 308 and 310 can be interchanged, such that reinforcement 310 can be (e.g., embedded) in layer 304 and reinforcement 308 can be (e.g., embedded) in layer 306. In such an arrangement, reinforcement 310 can be closer to lumen 104 than reinforcement 308, such that reinforcement 308 can extend (e.g., spirally) around reinforcement 310 when tube 160 is in an unexpanded state and when tube 160 is in an expanded state. As another example, with respect to Figures 13A-18H, the positions of reinforcement body 308 and reinforcement body 310 can be interchanged, such that reinforcement body 310 can be closer to lumen 104 than reinforcement body 308, thereby allowing reinforcement body 308 to extend (e.g., spirally) around reinforcement body 310 when tube 160 is in an unexpanded state and when tube 160 is in an expanded state.

[0251] Peak portions 344p of reinforcement members 308 can releasably engage with one another at points 350, for example, with reinforcement members 310 in tube 160. For example, Figures 12A-12H, 15A-15H, and 18A-18H illustrate that peak portions 344p of reinforcement members 308 can releasably engage with one another as described with reference to Figures 9A-9H. In other words, reinforcement members 308 in Figures 12A-12H, 15A-15H, and 18A-18H can function as described herein with reference to, for example, Figures 9A-9H.

[0252] The reinforcement 310 can be a braid, in which case the clockwise elements 310a can pass over and under the counterclockwise elements 310b, or the reinforcement 310 can be a spiral wrap, in which case the clockwise elements 310a can pass over or under the counterclockwise elements 310b. Figures 10A-18H, for example, show that the reinforcement 310 can be a spiral wrap, in which all of the clockwise elements 310a can pass over all of the counterclockwise elements 310b.

[0253] 10A-18H illustrate that clockwise element 310a can be farther from lumen 104 than counterclockwise element 310b when tube 160 is in an unexpanded state and when tube 160 is in an expanded state. For example, FIGS. 10A-18H illustrate that clockwise element 310a can be farther from lumen 104 than counterclockwise element 310b when tube 160 is in an unexpanded state and when tube 160 is in an expanded state, if clockwise element 310a and counterclockwise element 310b intersect with each other. As another example, FIGS. 10A-18H illustrate that reinforcement 310 can be braided.

[0254] 10A-18H show that when tube 160 is in an unexpanded state, clockwise element 310a and counterclockwise element 310b can intersect with one another at angle 316. FIGS. 10A-18H show that angle 316 can be twice the angle 311 between clockwise element 310a and counterclockwise element 310b and longitudinal axis 310x of stiffener 310. Low angle 311 (e.g., 5 to 45 degrees) between clockwise element 310a and counterclockwise element 310b and longitudinal axis 310x of stiffener 310 can correspond to angle 316 (also referred to as low angle 316) of 10 to 90 degrees, including one degree increments within this range (e.g., 10, 15, 30, 45, 60, 75, 90 degrees). When reinforcement body 310 has a low angle 316 between clockwise element 310a and counterclockwise element 310b, reinforcement body 310 can, for example, resist axial expansion but allow radial expansion. For example, reinforcement body 310 having a low angle 316 between clockwise element 310a and counterclockwise element 310b can allow tube 160 to passively increase in diameter (e.g., from diameter d1 to diameter d2) when an oversized device (e.g., device 329) is advanced along lumen 104, but can inhibit or prevent tube 160 from increasing in length when an oversized device (e.g., device 329) is advanced along lumen 104. Angle 316 can, for example, be a low angle when tube 160 is in a neutral (e.g., unexpanded) or contracted state. For example, Figures 10A-18H show that angle 316 can be a low angle when tub...

Claims

1. A tube main body; a reinforcement positioned on and / or within the wall of the tube body, wherein the reinforcement and the tube body are expandable from a neutral state to an expanded state, and the reinforcement is configured to inhibit or prevent kinking of the tube body.

2. 10. The expandable tubing of claim 1, wherein the reinforcement is configured to transmit axial forces along the length of the tube body and / or the reinforcement is configured to transmit torque along the tube body.

3. The expandable tubing of claim 1 , wherein the reinforcement comprises an undulating pattern.

4. 10. The expandable tubing of claim 1, wherein the reinforcement comprises a coil having a zigzag pattern.

5. 10. The expandable tubing of claim 1, wherein the reinforcement comprises a zigzag wire that extends helically around the lumen of the tube body for multiple turns.

6. 10. The expandable tubing of claim 1, wherein the tube body and the reinforcement are bendable into curves having a radius of 8.0 mm to 15.0 mm without kinking.

7. 10. The expandable tubing of claim 1, wherein the tube body and the reinforcement are bendable into curves having a radius of 12.7 mm or less without kinking.

8. A tube main body; a reinforcement positioned on and / or within the wall of the tube body, wherein the reinforcement and the tube body are expandable from a neutral state to an expanded state, and the reinforcement is configured to transmit a compressive force along the length of the tube body and / or to transmit a torque along the tube body.

9. 10. The expandable tubing of claim 8, wherein the reinforcement comprises an undulating pattern.

10. 9. The expandable tubing of claim 8, wherein the reinforcement comprises a zigzag wire that extends helically around the lumen of the tube body for multiple turns.

11. 10. The expandable tubing of claim 8, wherein the reinforcement includes an undulating pattern configured to transmit torque along the tube body.

12. 9. The expandable tubing of claim 8, wherein the reinforcement includes a peak-to-peak configuration configured to provide column strength to the tube body such that axial forces are transmittable along the length of the tube body.

13. 9. The expandable tubing of claim 8, wherein the reinforcement includes a nested configuration configured to provide column strength to the tube body such that axial forces are transmittable along the length of the tube body.

14. 9. The expandable tubing of claim 8, wherein the ratio of the wall thickness of the tube body to the diameter of the lumen of the tube body is comprised between 0.05 and 0.

10.

15. 9. The expandable tubing of claim 8, wherein the tube body and the reinforcement are bendable into curves having a radius of 12.7 mm or less without kinking.

16. a tube body portion; The expandable tubing is configured such that the tube body is radially expandable from a neutral state to an expanded state, the diameter of the tube body being greater when the tube body is in the expanded state than when the tube body is in the neutral state, and axial expansion of the tube body being inhibited or prevented.

17. 17. The expandable tubing of claim 16, wherein the tube body has the same length when the tube body is in the neutral state and when the tube body is in the expanded state.

18. 17. The expandable tubing of claim 16, wherein the tube body has a wall having a wall thickness that is the same when the tube body is in the neutral state and when the tube body is in the expanded state.

19. 17. The expandable tubing of claim 16, wherein the tube body has a wall having a wall thickness that is greater or less when the tube body is in the neutral state than when the tube body is in the expanded state.

20. 17. The expandable tubing of claim 16, wherein the axial expansion of the tube body is constrained or prevented via braiding or spiral wrapping.

21. 17. The expandable tubing of claim 16, wherein the tube body comprises radial ePTFE.

22. 22. The expandable tubing of claim 21, wherein the axial expansion of the tube body is constrained or prevented via the radial ePTFE.

23. 22. The expandable tubing of claim 21, wherein the radial ePTFE includes nodes and fibrils, and there is more slack in the fibrils when the tube body is in the neutral state than when the tube body is in the expanded state.

24. 24. The expandable tubing of claim 23, wherein the fibrils are in tension when the tube body is in the expanded state.

25. 25. The expandable tubing of claim 24, wherein the fibrils extend circumferentially around the tube body when the tube body is in the expanded state.

26. a tube body comprising radial ePTFE having nodes and fibrils; The expandable tubing, wherein the radial ePTFE is configured to allow radial expansion of the tube body but prevent axial expansion.

27. 27. The expandable tubing of claim 26, wherein there is more tension in the fibrils when the tube body is in an expanded state than when the tube body is in a neutral state.

28. 28. The expandable tubing of claim 27, wherein the nodes are denser when the tube body is in the neutral state than when the tube body is in the expanded state.

29. 28. The expandable tubing of claim 27, wherein the fibrils are more aligned when the tube body is in the expanded state than when the tube body is in the neutral state.

30. 27. The expandable tubing of claim 26, further comprising a zigzag wire and / or a braid, the zigzag wire configured to transmit a compressive axial force along the length of the tube body and / or configured to transmit a torque along the tube body, and the braid configured to transmit the torque along the tube body.

31. A tube main body; and an actuator positioned on and / or within the wall of the tube body portion, the actuator configured to expand axially and cause the tube body portion to expand radially, wherein axial expansion of the tube body portion is inhibited or prevented.

32. 32. The actively expandable tubing of claim 31, wherein the tube body has the same length when the tube body is in a neutral state and when the tube body is in an expanded state.

33. 32. The actively expandable tubing of claim 31, wherein the tube body has a wall with a wall thickness that is the same when the tube body is in a neutral state and when the tube body is in an expanded state.

34. 32. The actively expandable tubing of claim 31, wherein the tube body has a wall with a wall thickness that is greater or less when the tube body is in a neutral state than when the tube body is in an expanded state.

35. 32. The actively expandable tubing of claim 31, wherein the axial expansion of the tube body is constrained or prevented via braiding or spiral wrapping.

36. 32. The actively expandable tubing of claim 31, wherein the tube body comprises radial ePTFE.

37. 37. The actively expandable tubing of claim 36, wherein the axial expansion of the tube body is constrained or prevented via the radial ePTFE.

38. 37. The actively expandable tubing of claim 36, wherein the radial ePTFE includes nodes and fibrils, and there is more slack in the fibrils when the tube body is in a neutral state than when the tube body is in an expanded state.

39. 39. The actively expandable tubing of claim 38, wherein the fibrils are in tension when the tube body is in the expanded state.

40. 39. The actively expandable tubing of claim 38, wherein the fibrils extend circumferentially around the tube body when the tube body is in an expanded state.

41. a tube body comprising radial ePTFE; an actuator comprising axial ePTFE, wherein the radial ePTFE is configured to allow radial expansion of the tube body but prevent axial expansion, and the axial ePTFE is configured to allow axial expansion of the actuator but prevent radial expansion.

42. 42. The actively expandable tubing of claim 41, wherein the actuator is configured to expand axially and radially expand the tube body from a neutral state to an expanded state.

43. 43. The actively expandable tubing of claim 42, wherein when the tube body is in the neutral configuration, the radial ePTFE is configured to allow radial expansion of the tube body but prevent axial expansion, and when the tube body is in the neutral configuration, the axial ePTFE is configured to allow axial expansion of the actuator but prevent radial expansion.

44. 42. The actively expandable tubing of claim 41, wherein the radial ePTFE includes nodes and fibrils, and wherein there is greater tension in the fibrils when the tube body is in an expanded state than when the tube body is in a neutral state.

45. 45. The actively expandable tubing of claim 44, wherein the axial ePTFE includes nodes and fibrils, and wherein there is greater tension in the fibrils of the axial ePTFE when the actuator is in an actuated state than when the actuator is in an unactuated state.

46. 42. The actively expandable tubing of claim 41, wherein the tube body further comprises zigzag wires and / or braids, the zigzag wires configured to transmit compressive axial forces along the length of the tube body and / or configured to transmit torque along the tube body, and the braids configured to transmit the torque along the tube body.

47. 42. The actively expandable tubing of claim 41, wherein the actuator further comprises a braid, the braid configured to transmit the torque along the tube body.

48. An inexpandable tubing comprising a tube body portion having a reinforcement body, the reinforcement body being spirally wound around the lumen of the tube body portion, and kinking of the tube body portion being preventable via the reinforcement body.

49. 49. The non-expandable tubing of claim 48, wherein the reinforcement is configured to transmit compressive forces along the length of the tube body and / or to transmit torque along the tube body.

50. 49. The non-expandable tubing of claim 48, wherein the reinforcement comprises zigzag wires.

51. 49. The non-expandable tubing of claim 48, wherein the reinforcement includes an undulating pattern configured to transmit torque along the tube body.

52. 49. The non-expandable tubing of claim 48, wherein the reinforcement includes a peak-to-peak configuration configured to provide column strength to the tube body such that axial forces are transmittable along the length of the tube body.

53. 49. The non-expandable tubing of claim 48, wherein the reinforcement includes a nested configuration configured to provide column strength to the tube body such that axial forces are transmittable along the length of the tube body.

54. 49. The non-expandable tubing of claim 48, wherein the ratio of the wall thickness of the tube body to the diameter of the lumen of the tube body is comprised between 0.05 and 0.

10.

55. 49. The non-expandable tubing of claim 48, wherein the tube body and the reinforcement are bendable into curves having a radius of 12.7 mm or less without kinking.

56. a tube body having a lumen; a first reinforcement in and / or on the wall of the tube body; An actuator; a second reinforcement in and / or on the wall of the actuator; Including, A tube, wherein the first reinforcement is configured to limit or prevent axial expansion of the tube body portion, and the second reinforcement is configured to limit or prevent radial expansion of the actuator.

57. 57. The tube of claim 56, wherein the first reinforcement includes a first clockwise element and a counterclockwise element.

58. 58. The tube of claim 57, wherein when the tube is in a neutral state, an angle between the first clockwise and counterclockwise elements and a longitudinal axis of the first reinforcement body comprises a low angle.

59. 59. The tube of claim 58, wherein the low angle comprises an angle of 5 degrees to 45 degrees.

60. 58. The tube of claim 57, wherein when the tube is in a neutral state, angles between the first clockwise and counterclockwise elements and a longitudinal axis of the first reinforcement body comprise a minimum low angle.

61. 61. The tube of claim 60, wherein the minimum low angle comprises an angle between 5 degrees and 15 degrees.

62. 57. The tube of claim 56, wherein the second reinforcement includes a second clockwise element and a counterclockwise element.

63. 63. The tube of claim 62, wherein when the tube is in a neutral state, an angle between the second clockwise and counterclockwise elements and a longitudinal axis of the second reinforcement body comprises a high angle.

64. 64. The tube of claim 63, wherein the high angle comprises an angle between 46 degrees and 85 degrees.

65. 63. The tube of claim 62, wherein angles between second clockwise and counterclockwise elements and a longitudinal axis of the first reinforcement body comprise a maximum high angle when the tube is in a neutral state.

66. 66. The tube of claim 65, wherein the maximum high angle comprises an angle of 75 degrees to 85 degrees.

67. 57. The tube of claim 56, wherein the first reinforcement includes a first clockwise element and a counterclockwise element, and the second reinforcement includes a second clockwise element and a counterclockwise element.

68. 68. The tube of claim 67, wherein when the tube is in a neutral state, an angle between the first clockwise and counterclockwise elements and a longitudinal axis of the first reinforcement body comprises a low angle, and when the tube is in a neutral state, an angle between the second clockwise and counterclockwise elements and a longitudinal axis of the second reinforcement body comprises a high angle.

69. 69. The tube of claim 68, wherein the low angle comprises an angle between 5 degrees and 45 degrees, and the high angle comprises an angle between 46 degrees and 85 degrees.

70. 68. The tube of claim 67, wherein when the tube is in a neutral state, an angle between the first clockwise and counterclockwise elements and a longitudinal axis of the first reinforcement body comprises a minimum low angle, and when the tube is in a neutral state, an angle between the second clockwise and counterclockwise elements and a longitudinal axis of the first reinforcement body comprises a maximum high angle.

71. 71. The tube of claim 70, wherein the minimum low angle comprises an angle between 5 degrees and 15 degrees, and the maximum high angle comprises an angle between 75 degrees and 85 degrees.

72. 57. The tube of claim 56, wherein the actuator extends around the lumen.

73. 73. The tube of claim 72, wherein the actuator and the second reinforcement extend helically around the lumen.

74. 74. The tube of claim 73, wherein the actuator comprises a layer.

75. 57. The tube of claim 56, wherein the second reinforcement body includes a second reinforcement body lumen.

76. 76. The tube of claim 75, wherein the second reinforcement lumen extends helically around the lumen.

77. 57. The tube of claim 56, wherein the first reinforcement extends around the lumen.

78. 78. The tube of claim 77, wherein the second reinforcement extends around the lumen and the first reinforcement.

79. 57. The tube of claim 56, wherein the tube further comprises a third reinforcement.

80. 80. The tube of claim 79, wherein the third reinforcement comprises a coil having an undulating pattern.

81. 80. The tube of claim 79, wherein the third reinforcement comprises a coil having a zigzag shape.

82. 80. The tube of claim 79, wherein the third reinforcement comprises a zigzag wire helically wrapped around the lumen.

83. 57. The tube of claim 56, wherein the first reinforcement is configured to transmit torque along the tube body.

84. 57. The tube of claim 56, further comprising a third reinforcement configured to inhibit or prevent kinking of the tube body, configured to transmit axial forces along the length of the tube body, and / or configured to transmit torque along the tube body.

85. 85. The tube of claim 84, wherein the third reinforcement comprises a zigzag wire helically wrapped around the lumen.

86. a tube body having a lumen; reinforcement in and / or on the wall of said tube body; Including, the reinforcement includes a first turn and a second turn around the lumen; the reinforcement body has a first configuration and a second configuration; when the reinforcement has the first configuration, the first turn and the second turn are separated by a gap greater than 1.5 mm; A tube, wherein when the reinforcement has the second configuration, the first turn and the second turn are in contact with each other or separated by a gap of less than 1.5 mm.

87. 87. The tube of claim 86, wherein the tube body is stiffer when the reinforcement body has the second configuration than when the reinforcement body has the first configuration.

88. 88. The tube of claim 86 or 87, wherein the tube body has a radius of curvature limit, and the tube body is constrained or prevented from becoming smaller than the radius of curvature limit when the first turn and the second turn are in contact with each other or separated by the gap of less than 1.5 mm.

89. 89. The tube of any one of claims 86 to 88, wherein the radius of curvature limits are inclusively between 8.0 mm and 20.0 mm.

90. 90. The tube of any one of claims 86 to 89, wherein the radius of curvature limit comprises 12.7 mm.

91. 91. The tube of any one of claims 86 to 90, wherein the tube body is bendable from a first curve to a second curve, the first curve having a first radius of curvature and the second curve having a second radius of curvature, the first radius of curvature being greater than the second radius of curvature, and when the tube body has the first curve, the first turn and the second turn are separated at the first curve by the gap being greater than 1.5 mm, and when the tube body has the second curve, the first turn and the second turn are either in contact with each other or are separated at the second curve by the gap being less than 1.5 mm.

92. 92. The tube of any one of claims 86 to 91, wherein the second radius of curvature is in the range of 8.0 mm to 20.0 mm, and the first radius of curvature is in the range of 1.0 mm to 7.0 mm or 1.0 mm to 19.0 mm greater than the second radius of curvature.

93. 93. The tube of any one of claims 86 to 92, wherein the second radius of curvature comprises 12.7 mm and the first radius of curvature is between 0.1 mm and 12.6 mm greater than the second radius of curvature.

94. 94. The tube of any one of claims 86 to 93, wherein the reinforcing member has the first configuration when the tube body has a straight configuration, and the reinforcing member has the second configuration when the tube body has a curved configuration.

95. 95. A tube as described in any one of claims 86 to 94, wherein kinking of the tube body portion is suppressed or prevented via the reinforcement when the first turn and the second turn are in contact with each other or separated by the gap less than 1.5 mm.

96. 96. The tube of any one of claims 86 to 95, wherein the proximity between the first turn and the second turn inhibits or prevents kinking of the tube body when the first turn and the second turn are in contact with each other or separated by the gap of less than 1.5 mm.

97. 97. A tube as described in any one of claims 86 to 96, wherein the reinforcement allows bending of the tube in a first direction when the first turn and the second turn are separated by the gap greater than 1.5 mm, and the reinforcement inhibits or prevents bending of the tube in the first direction when the first turn and the second turn are in contact with each other or separated by the gap less than 1.5 mm.

98. 98. The tube of any one of claims 86 to 97, wherein the reinforcement allows bending of the tube in a second direction opposite to the first direction when the first turn and the second turn are in contact with each other or separated by the gap of less than 1.5 mm.

99. 99. The tube of any one of claims 86 to 98, wherein the tube is bendable in a first direction when the first turn and the second turn are separated by the gap greater than 1.5 mm, and bending of the tube in the first direction is inhibited or prevented via the contact or proximity between the first turn and the second turn when the first turn and the second turn are in contact with each other or separated by the gap less than 1.5 mm.

100. 100. The tube of any one of claims 86 to 99, wherein the tube is bendable in a second direction opposite to the first direction when the first turn and the second turn are in contact with each other or separated by the gap of less than 1.5 mm.

101. 101. The tube of any one of claims 86 to 100, wherein the tube body has a radius of curvature limit, and when the first turn and the second turn are in contact with each other or separated by the gap of less than 1.5 mm, the proximity between the first turn and the second turn inhibits or prevents the tube body from exceeding the radius of curvature limit.

102. 102. The tube of any one of claims 86 to 101, wherein the radius of curvature limits are inclusively between 8.0 mm and 20.0 mm.

103. 103. The tube of any one of claims 86 to 102, wherein the radius of curvature limit comprises 12.7 mm.

104. 104. The tube of any one of claims 86 to 103, wherein the first turn and the second turn are movable into and out of contact with each other.

105. 105. The tube of any one of claims 86 to 104, wherein the reinforcement comprises a structure having an undulating pattern.

106. 106. The tube of any one of claims 86 to 105, wherein the reinforcement comprises zigzag wire.

107. 107. The tube of any one of claims 86 to 106, wherein the first turn is nested with the second turn when the tube body has a straight configuration, and the first turn is nested with the second turn when the tube body has a curved configuration.

108. 108. The tube of any one of claims 86 to 107, wherein when the tube body has a straight configuration, the first turn is in a non-nested position adjacent to the second turn, and when the tube body has a curved configuration, the first turn is nested with the second turn.

109. 109. The tube of any one of claims 86 to 108, wherein the first turn is not nested with the second turn when the tube body has a straight configuration, and the first turn is nested with the second turn when the tube body has a curved configuration.

110. 110. The tube of any one of claims 86 to 109, wherein when the first turn and the second turn are in contact with each other or separated by the gap less than 1.5 mm, a peak portion of the first turn is in contact with a portion of the second turn or separated from the portion of the second turn by the gap less than 1.5 mm.

111. 111. The tube of any one of claims 86 to 110, wherein the portion of the second turn includes a peak portion of the second turn.

112. 112. The tube of any one of claims 86 to 111, wherein when the first turn and the second turn are separated by the gap, the peak portion of the first turn and the portion of the second turn are separated by the gap.

113. 113. The tube of any one of claims 86 to 112, wherein the portion of the second turn includes a peak portion of the second turn.

114. 114. The tube of any one of claims 86 to 113, wherein when the first turn and the second turn are in contact with each other or separated by the gap less than 1.5 mm, the peak of the first turn is in contact with the peak of the second turn or separated from the peak of the second turn by the gap less than 1.5 mm.

115. 115. A tube as described in any one of claims 86 to 114, wherein the reinforcement includes arms, and when the first turn and the second turn are in contact with each other, the arms of the first turn are in contact and / or proximity with the arms of the second turn.

116. 116. The tube of any one of claims 86 to 115, wherein when the first turn and the second turn are separated by the gap, the arm of the first turn and the arm of the second turn are separated by the gap.

117. 117. The tube of any one of claims 86 to 116, wherein the tube comprises a catheter.

118. 118. A tube as described in any one of claims 86 to 117, wherein the reinforcement extends spirally around the lumen.

119. 119. The tube of any one of claims 86 to 118, wherein the first turn and the second turn extend helically around the lumen.

120. a tube body having a lumen; reinforcement in and / or on the wall of said tube body; Including, A tube, wherein the reinforcement includes a first turn and a second turn around the lumen, the first turn and the second turn being movable toward and away from each other, and the tube body portion having a radius of curvature limit, and when the first turn and the second turn are in contact with and / or in proximity to each other, the tube body portion is inhibited or prevented from exceeding the radius of curvature limit.

121. a tube body having a lumen; reinforcement in and / or on the wall of said tube body; Including, the reinforcement body has a first configuration and a second configuration; A tube, wherein when the reinforcement body has the first configuration, the reinforcement body includes a first structure and a second structure, and when the reinforcement body has the second configuration, the reinforcement body includes the second structure.

122. 122. The tube of claim 121, wherein the first structure comprises a braid or a spiral wrap and the second structure comprises a coil.

123. 123. The tube of claim 121 or 122, wherein the coil has an undulating pattern.

124. 124. The tube of any one of claims 121 to 123, wherein the undulating pattern comprises a zigzag shape.

125. 125. The tube of any one of claims 121 to 124, wherein the coil comprises zigzag wire.

126. 126. A tube as described in any one of claims 121 to 125, wherein the braid or the spiral wrap includes the coil.

127. 127. A tube as described in any one of claims 121 to 126, wherein the coil defines the braid or the spiral wrap.

128. 128. A tube as described in any one of claims 121 to 127, wherein the braid or the spiral wrap is formed by the coil.

129. 129. A tube as described in any one of claims 121 to 128, wherein the braid or the spiral wrap includes a node, the node being formed by a point where two adjacent turns of the coil are 0.0 mm to 1.5 mm apart.

130. 130. A tube as claimed in any one of claims 121 to 129, wherein the points comprise force and / or torque transfer points between adjacent turns of the coil.

131. 131. A tube as described in any one of claims 121 to 130, wherein points between adjacent turns of the coil simulate nodes of the braid or the spiral wrap.

132. 132. A tube as described in any one of claims 121 to 131, wherein points between adjacent turns of the coil simulate nodes of the braid or the spiral wrap.

133. 133. A tube as claimed in any one of claims 121 to 132, wherein the reinforcement has the first configuration when the tube is in a straight configuration.

134. 134. A tube according to any one of claims 121 to 133, wherein the reinforcement has the second configuration when the tube is in a curved configuration.

135. 135. A tube as claimed in any one of claims 121 to 134, wherein the reinforcing body comprises the first structure when the reinforcing body has the second configuration.

136. 136. The tube of any one of claims 121 to 135, wherein when the reinforcement body has the second configuration, the reinforcement body includes the first structure at a first location along the reinforcement body and the second structure at a second location along the reinforcement body.

137. 137. The tube of any one of claims 121 to 136, wherein the straight configuration of the tube includes the first location along the reinforcement and the curved configuration includes the second location along the reinforcement.

138. 138. The tube of any one of claims 121 to 137, wherein the first structure comprises a braid or a spiral wrap and the second structure comprises a coil.

139. 139. The tube of any one of claims 121 to 138, wherein when the reinforcement has the second configuration, the reinforcement includes the first structure, and when the reinforcement has the second configuration, the reinforcement includes the first structure at a first location along the reinforcement and the second structure at a second location along the reinforcement.

140. 140. A tube as described in any one of claims 121 to 139, wherein the first structure comprises braided or spiral wrapped characteristics and the second structure comprises coiled characteristics.

141. 141. The tube of any one of claims 121 to 140, wherein the coil has an undulating pattern.

142. 142. The tube of any one of claims 121 to 141, wherein the undulating pattern comprises a zigzag shape.

143. 143. The tube of any one of claims 121 to 142, wherein the first structure comprises openable and closable cells.

144. 144. A tube as claimed in any one of claims 121 to 143, wherein the cells are openable when the reinforcement has the first configuration.

145. 145. A tube as claimed in any one of claims 121 to 144, wherein the cells are closable when the reinforcement has the second configuration.

146. 146. A tube as described in any one of claims 121 to 145, wherein the reinforcement includes a first turn and a second turn around the lumen.

147. 147. The tube of any one of claims 121 to 146, wherein the first turn and the second turn extend helically around the lumen.

148. 148. A tube as described in any one of claims 121 to 147, wherein the first structure is in and / or on the wall of the tube body portion and the second structure is in and / or on the wall of the tube body portion.

149. a tube body having a lumen; a framework having openable and closable cells in and / or on the wall of said tube body; Including, the framework has a first configuration and a second configuration; A tube, wherein a first cell of the openable and closable cells is openable when the framework has the first configuration, and the first cell is closable when the framework has the second configuration.

150. 150. The tube of claim 149, wherein when the framework has the first configuration, the first cells are openable from a closed configuration to an open configuration, and when the framework has the second configuration, the first cells are closeable from the open configuration to the closed configuration.

151. 151. The tube of claim 149 or 150, wherein the first cells are in a closed configuration when the framework has the first configuration, and the first cells are in an open configuration when the framework has the second configuration.

152. 152. A tube as described in any one of claims 149 to 151, wherein the framework includes the first cells in the closed configuration when the tube is in a straight configuration.

153. 153. A tube according to any one of claims 149 to 152, wherein the framework comprises the first cells in the open configuration when the tube is in the curved configuration.

154. 154. The tube of any one of claims 149 to 153, wherein a straight portion of the tube body having the straight configuration includes the first cell in the closed configuration, and a curved portion of the tube body having the curved configuration includes the first cell in the open configuration.

155. 155. The tube of any one of claims 149 to 154, wherein the first cell is completely closed when the first cell is in the closed configuration.

156. 156. The tube of any one of claims 149 to 155, wherein the first cell includes a first side, a second side, a third side, and a fourth side when the first cell is in the closed configuration.

157. 157. The tube of any one of claims 149 to 156, wherein the first cell comprises a diamond shape when the first cell is in the closed configuration.

158. 158. The tube of any one of claims 149 to 157, wherein the first cell is defined by a first turn and a second turn of the framework when the first cell is in the closed configuration.

159. 159. A tube as described in any one of claims 149 to 158, wherein the first turn and the second turn of the framework extend helically around the lumen.

160. 160. The tube of any one of claims 149 to 159, wherein the framework includes an undulating pattern defined by arms including a first arm, a second arm, a third arm, and a fourth arm, and when the first cell is in the closed configuration, the first arm, the second arm, the third arm, and the fourth arm define a perimeter of the first cell.

161. 161. A tube as described in any one of claims 149 to 160, wherein the framework includes a coil having a zigzag shape that extends helically around the lumen.

162. 162. The tube of any one of claims 149 to 161, wherein the framework includes a braid and a coil when the first cell is in the closed configuration, and the framework includes the coil when the first cell is in the open configuration.

163. 163. The tube of any one of claims 149 to 162, wherein the framework comprises the characteristics of a braid and a coil when the first cell is in the closed configuration, and the framework comprises the characteristics of the coil when the first cell is in the open configuration.

164. a tube body having a lumen; reinforcement in and / or on the wall of said tube body; Including, the reinforcement includes openable and closeable nodes; A tube, wherein when the reinforcement has a first configuration, a first one of the openable and closable nodes is in a closed configuration, and when the reinforcement has the second configuration, the first node is in an open configuration.

165. 165. The tube of claim 164, wherein a force is transferable across the first node when the first node is in the closed configuration.

166. 166. The tube of claim 164 or 165, wherein less force is transferable across the first node when the first node is in the open configuration.

167. 167. The tube of any one of claims 164 to 166, wherein zero force is transferable across the first node when the first node is in the open configuration.

168. 168. The tube of any one of claims 164 to 167, wherein when the first node is in the closed configuration, the first portion of the first node and the second portion of the first node are 0.0 mm to 1.5 mm apart.

169. 169. The tube of any one of claims 164 to 168, wherein when the first node is in the open configuration, the first portion of the first node and the second portion of the first node are separated from each other by a gap.

170. 170. The tube of any one of claims 164 to 169, wherein material is in the gap.

171. 171. The tube of any one of claims 164 to 170, wherein the reinforcement includes a first turn and a second turn, the first turn including the first portion of the first node, and the second turn including the second portion of the first node.

172. 172. The tube of any one of claims 164 to 171, wherein the first turn and the second turn are adjacent to each other.

173. 173. The tube of any one of claims 164 to 172, wherein the first turn is adjacent to the second turn.

174. 174. A tube as described in any one of claims 164 to 173, wherein the first turn and the second turn extend helically around the lumen.

175. 175. The tube of any one of claims 164 to 174, wherein when the first node is in the closed configuration, force is transferable from the first turn to the second turn across the first node.

176. 176. The tube of any one of claims 164 to 175, wherein when the first node is in the open configuration, force is transferable along the first turn and the second turn, and when the first node is in the closed configuration, force is transferable along the first turn and the second turn and from the first turn to the second turn across the first node.

177. 177. The tube of any one of claims 164 to 176, wherein when the first node is in the open configuration, torque is transferable along the first turn and the second turn, and when the first node is in the closed configuration, torque is transferable along the first turn and the second turn, and axial force is transferable from the first turn to the second turn across the first node.

178. 178. The tube of any one of claims 164 to 177, wherein when the first node is in the open configuration, the reinforcement comprises a coil, and when the first node is in the closed configuration, the reinforcement comprises the coil and a braid.

179. 179. A tube as described in any one of claims 164 to 178, wherein when the first node is in the open configuration, the reinforcement comprises a coil, and when the first node is in the closed configuration, the reinforcement comprises the coil and a spiral wrap.

180. 179. A tube as described in any one of claims 164 to 179, wherein when the first node is in the open configuration, the reinforcement body has the properties of a coil, and when the first node is in the closed configuration, the reinforcement body has the properties of the coil and the properties of a braid.

181. 181. A tube as described in any one of claims 164 to 180, wherein when the first node is in the open configuration, the reinforcement body has the properties of a coil, and when the first node is in the closed configuration, the reinforcement body has the properties of the coil and the properties of a spiral wrap.

182. 182. The tube of any one of claims 164 to 181, wherein the reinforcement comprises a first reinforcement when the first node is in the open configuration, and the reinforcement comprises a second reinforcement when the first node is in the closed configuration.

183. 183. A tube as claimed in any one of claims 164 to 182, wherein the openable and closeable nodes comprise the openable and closeable force and / or torque transfer points.

184. an outer tube body including a lumen; a reinforcement within the outer tube body; Including, the reinforcement extends helically around the lumen for at least one full turn in a continuous undulating manner within the outer tube body; An expandable tubing, wherein an entire turn of the at least one full turn of the reinforcement is expandable and contractible.

185. the reinforcement is configured to assist the expansion of the outer tube body when a device is passed through the lumen of the outer tube body; 185. The expandable tubing of claim 184, wherein the reinforcement is expandable and contractible such that expansion of the reinforcement expands the diameter of the outer tube body portion.

186. 186. The expandable tubing of claim 184 or 185, wherein the outer tube body is expandable by advancing a device into the lumen, and the outer tube body is contractable by withdrawing the device from the lumen.

187. the outer tube body has a natural state and an expanded state; When the outer tube body is in the natural state, the reinforcing member is biased to expand the diameter of the outer tube body, when the outer tube body is in the expanded state, the outer tube body is biased to contract the diameter of the outer tube body; the outer tube body is expandable from the native state to the expanded state by advancing a device through the lumen; the outer tube body is retractable from the expanded state to the natural state by withdrawing the device from the lumen; 187. The expandable tubing of any one of claims 184 to 186, wherein the reinforcement has a first shape when the outer tube body portion is in the natural state, and the reinforcement has a second shape different from the first shape when the outer tube body portion is in the expanded state.

188. 188. The expandable tubing of any one of claims 184 to 187, wherein the reinforcement is configured to naturally return to a more expanded configuration when the device is advanced through the lumen, thereby reducing the force required to expand the diameter of the outer tube body portion through the device.

189. the outer tube body has a natural state and an expanded state; the outer tube body is expandable from the natural state to the expanded state due to a device in the lumen, and the reinforcement is configured to naturally return to a more expanded configuration as the device is advanced through the lumen, thereby reducing the force required to expand the diameter of the outer tube body via the device; 189. The expandable tubing of any one of claims 184 to 188, wherein the outer tube body is contractible from the expanded state to the natural state due to the device in the lumen, and wherein the outer tube body is configured to contract the diameter of the outer tube body when the device is retracted from the lumen.

190. the outer tube body has a natural state and an expanded state; When the outer tube body is in the natural state, the reinforcing member is biased to expand the diameter of the outer tube body, when the outer tube body is in the expanded state, the outer tube body is biased to contract the diameter of the outer tube body; the outer tube body is expandable from the natural state to the expanded state due to a device in the lumen, and the reinforcement is configured to naturally return to a more expanded configuration as the device is advanced through the lumen, thereby reducing the force required to expand the diameter of the outer tube body via the device; the outer tube body is contractible from the expanded state to the natural state due to the device in the lumen, and the outer tube body is configured to contract the diameter of the outer tube body when the device is retracted from the lumen; 189. The expandable tubing of any one of claims 184 to 189, wherein the reinforcement has a first shape when the outer tube body portion is in the natural state, and the reinforcement has a second shape different from the first shape when the outer tube body portion is in the expanded state.

191. 191. The expandable tubing of any one of claims 184 to 190, wherein the expandable tubing further comprises a coil or braid within the outer tube body.

192. 192. The expandable tubing of any one of claims 184 to 191, wherein the continuous undulating pattern comprises a zigzag pattern.

193. 193. The expandable tubing of any one of claims 184 to 192, wherein the reinforcement comprises zigzag wires.

194. 194. The expandable tubing of any one of claims 184 to 193, wherein the reinforcement includes peaks and valleys, adjacent peaks being within adjacent valleys.

195. 195. The expandable tubing of any one of claims 184 to 194, wherein the reinforcement has a zigzag pattern including peaks and valleys, and adjacent peaks are separated from adjacent valleys by gaps.

196. 196. The expandable tubing of any one of claims 184 to 195, wherein the expandable tubing further comprises a coil or braid within the outer tube body.

197. an outer tube body including a lumen; a coil or braid within the outer tubular body; a reinforcement wound in an undulating manner within the outer tube body; Including, the reinforcement extends around the lumen; the outer tube body is expandable via the reinforcement; the reinforcement body is contractible via the outer tube body portion; The expandable tubing, wherein the coil or braid extends around the lumen radially inside or outside the reinforcement body.

198. 198. The expandable tubing of claim 197, wherein adjacent turns of the reinforcement are separated by a gap, the gap being less than the peak-to-peak amplitude of the continuous undulating pattern in the turns of the reinforcement.

199. The expandable tubing of claim 197 or 198, wherein the continuous undulating pattern of the reinforcement includes peaks and valleys, and the peaks of adjacent turns of the reinforcement are separated by a gap, the gap being smaller than the peak-to-peak amplitude of two adjacent peaks in a single turn of the reinforcement.

200. The expandable tubing of any one of claims 197 to 199, wherein the reinforcement extends spirally around the lumen within the outer tube body portion in a continuous undulating manner for at least a first full turn and a second full turn, the continuous undulating manner of the reinforcement including peaks and valleys, and a gap between the first full turn and the second full turn is less than a peak-to-peak amplitude between a first peak of the first full turn and a second peak of the first full turn.

201. The expandable tubing of any one of claims 197 to 200, wherein the reinforcement extends spirally around the lumen over multiple turns in a continuous undulating manner within the outer tube body, the continuous undulating manner of the reinforcement including peaks and valleys, and the peaks of adjacent turns are aligned with each other longitudinally along the length of the outer tube.

202. The expandable tubing of any one of claims 197 to 201, further comprising a material that extends spirally around the lumen, the material being radially inward of the reinforcement body or radially outward of the reinforcement body.

203. 203. The expandable tubing of any one of claims 197 to 202, wherein the coil or braid extends spirally around the lumen, radially inside or radially outside the reinforcement body.

204. an outer tube body including a lumen; a reinforcement within the outer tube body; Including, the reinforcement extends around the lumen; the reinforcement is expandable and contractible; an expandable tubing, wherein the reinforcement extends helically around the lumen over a first full turn and a second full turn in a continuous undulating manner within the outer tube body, the first full turn being adjacent to the second full turn, the continuous undulating manner of the reinforcement including peaks and valleys, and the peaks of the first full turn being within the valleys of the second full turn.

205. The expandable tubing of claim 204, wherein the reinforcement comprises a spring material.

206. 206. The expandable tubing of claim 204 or 205, wherein the reinforcement comprises a spring.

207. Any combination of the features disclosed herein.

208. Any combination of the features shown and / or described herein.

209. Any device, any system, and / or any method disclosed herein.

210. A device having any combination of the features disclosed herein.

211. A system having any combination of the features disclosed herein.

212. A method comprising any combination of the processes disclosed herein.

213. A method having any combination of the steps disclosed herein.

214. Any of the tubes disclosed herein.

215. A tube having any combination of the features disclosed herein.

216. A tube having any combination of the features in Figures 1A-62.

217. A tube having any combination of the features described herein and / or any combination of the features shown in Figures 1A-62.

218. A method for expanding and / or contracting a tube as disclosed herein.

219. A method of expanding a tube as disclosed herein.

220. A method for shrinking a tube as disclosed herein.

221. Methods of using the devices and / or systems disclosed herein.

222. Methods of using the tubes disclosed herein.

223. A device, product, process, system, kit, component, or method of use characterized by including one or more elements disclosed herein.

224. A device, product, process, system, kit, component, or method of use characterized by including one or more features disclosed herein.

225. Any combination of claims 1 to 224.

Citation Information

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