Catheter with distal and proximal fixation members

By using molded distal and proximal fixation components connected to the traction line in a deflectable catheter, combined with damping component control, the problem of the catheter's inability to actively return after deflection is solved, achieving active catheter recovery and improved operational stability.

CN114007679BActive Publication Date: 2025-11-18MEDTRONIC INC
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Patent Information

Application Number
CN202080046506.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2020-07-01
Filing Date
2020-07-14
Publication Date
2025-11-18
Estimated Expiration
2040-07-14

AI Technical Summary

Technical Problem

Existing deflectable shaft catheters cannot effectively and actively return to their initial configuration when the control components are released. This may be due to the strain or plastic deformation of the slender components, which may prevent them from fully recovering, thus affecting the operating accuracy and efficiency of the catheter.

Method used

The distal and proximal fixation components are molded and covered. The connection between the traction line and the fixation components enables the effective transmission of traction and thrust on the catheter shaft. Combined with the damping component, the active return of the catheter is controlled, ensuring that the catheter can actively return to its initial state under deflection configuration.

Benefits of technology

This technology enables the catheter to actively return to its initial configuration after deflection, improving the accuracy and efficiency of catheter operation, reducing loosening issues caused by strain or plastic deformation, and enhancing the functional stability of the catheter.

✦ Generated by Eureka AI based on patent content.

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Abstract

The deflectable catheter includes an elongate member having a wall defining a longitudinally extending lumen extending from a proximal end to a distal end, a fixation member coupled to an outer surface of the wall on a distal portion of the elongate member, and a pull wire extending from the proximal end of the elongate member through the wall of the elongate member to the fixation member. The pull wire is coupled to the fixation member and constrained along its length such that the elongate member is configured to deflect from an initial configuration to a deflected configuration in response to a pulling force applied to the pull wire and to actively return from the deflected configuration to the initial configuration in response to a pushing force applied to the pull wire.
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Description

Technical Field

[0001] This disclosure relates to medical systems and technologies including deflectable axial catheters. Background Technology

[0002] Interventional medicine techniques may use deflectable axial catheters to deliver medical treatments and / or provide medical monitoring. Typically, a deflectable axial catheter includes a traction line extending along its length, with the distal end of the traction line anchored to a traction band on the axis at a location just away from the deflectable segment. The proximal end of the traction line is typically secured to a control component subassembly mounted in the catheter handle. Summary of the Invention

[0003] This disclosure describes an example medical system including a deflectable catheter and techniques for using and manufacturing such a catheter. The described deflectable catheter includes a traction line that may have a molded distal end, a molded proximal end, or both. The assembly of the molded distal and / or proximal ends can provide a substantially leak-free channel to the traction line, enabling thrust to be applied to the traction line (e.g., via a control member). For example, when the catheter handle is grasped, a clinician can actuate the traction line by applying force to the control member, thereby deflecting the catheter shaft from an initial (e.g., substantially straight) configuration to a deflected (e.g., bent or otherwise zigzagged) configuration. The deflected configuration allows the clinician to manipulate the distal portion of the shaft toward a target site within the patient's body. Upon releasing the control member or actively returning the control member to its original position, the traction line can actively apply thrust from the control member to the distal end of the catheter shaft to return the catheter shaft to its initial configuration.

[0004] In some instances, the catheter may include an elongated portion, a fixation portion, and a traction wire. The elongated portion may extend from a proximal end to a distal end, wherein the elongated portion includes a wall defining a longitudinally extending lumen. The fixation portion may be coupled to the outer surface of the wall on the distal portion of the elongated portion. The traction wire may extend from the proximal end of the elongated portion through the wall of the elongated portion to the fixation portion. The traction wire may be coupled to the fixation portion. The elongated portion may be configured to deflect from an initial configuration to a deflected configuration in response to a traction force applied to the traction wire.

[0005] In some instances, the catheter may include an elongated portion extending from a proximal end to a distal end, the elongated portion including a wall defining a longitudinally extending lumen; a distal fixation portion coupled to an outer surface of the wall on a distal portion of the elongated portion; a proximal fixation portion coupled to an outer surface of the wall on a proximal portion of the elongated portion; a retaining arm integrally formed with the proximal fixation portion, wherein the retaining arm may be configured to retain a traction line in sliding engagement at an angle extending away from the longitudinal axis of the elongated portion; a traction line extending from the distal end coupled to the distal fixation portion through the wall of the elongated portion to a distal portion extending through the proximal fixation portion and the retaining arm, and wherein the elongated portion is configured to deflect from an initial configuration to a deflected configuration in response to a traction force applied to the traction line.

[0006] In some instances, a method may include forming an elongated member extending from a proximal end to a distal end, the elongated member including a wall defining a longitudinally extending lumen. The method may also include overmolding a retaining member onto the outer surface of the wall on the distal portion of the elongated member. The method may further include anchoring a traction wire to the retaining member, the traction wire extending from the proximal end of the elongated member through the wall of the elongated member to the retaining member, and the elongated member being configured to deflect from an initial configuration to a deflected configuration in response to a traction force applied to the traction wire.

[0007] Details of one or more examples are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages will be apparent from the description, the drawings, and the claims. Attached Figure Description

[0008] Figure 1 These are schematic diagrams and conceptual diagrams illustrating a plan view of an example deflectable conduit.

[0009] Figure 2A and 2B It is a conceptual diagram showing the transverse and axial cross-sectional views of an example conduit.

[0010] Figure 3A and 3B It is a photograph illustrating the distal fixation component of the example catheter at the distal end of the slender part.

[0011] Figure 4 It is a conceptual schematic diagram illustrating different configurations of the distal end of the traction wire of the catheter in various examples.

[0012] Figures 5A to 5D These are conceptual diagrams and schematic illustrations of the distal cup-shaped component at the distal end of the slender part connected to the example conduit.

[0013] Figure 6 It is a photograph illustrating the proximal fixation component at the proximal end of the slender part of the example catheter.

[0014] Figure 7A and 7B It is a diagram used to... Figure 6 A photograph of an example mold showing the proximal fixation component being molded onto the example catheter.

[0015] Figures 8A to 8C The images depict an example hub assembly and an example outer edge surround of the conduit.

[0016] Figures 9A to 9F These are photographs and concept diagrams illustrating an example handle of a deflection assembly for a conduit.

[0017] Figures 10A to 10C This is a conceptual diagram illustrating an example of a deflectable conduit with a deflection assembly including damping components.

[0018] Figure 11 It is a flowchart illustrating an example method for manufacturing an elongated component of a deflectable conduit.

[0019] Figure 12 This is a flowchart illustrating an example method for manufacturing a deflectable assembly of a deflectable conduit.

[0020] Figure 13 It is a flowchart illustrating an example method using a deflectable conduit. Detailed Implementation

[0021] This disclosure describes an example medical system including a deflectable catheter and techniques for using and manufacturing the deflectable catheter. The example deflectable catheter includes an elongated portion and a deflection assembly. The deflection assembly includes a handle, an elongated traction wire, and a control component. The elongated portion includes a wall extending from a proximal end to a distal end and defining a longitudinally extending lumen. The proximal end of the elongated portion can be coupled to the handle of the deflection assembly. The elongated traction wire of the deflection assembly extends from a fixation component at the distal portion of the elongated portion to the control component, for example, through at least a portion of the wall of the elongated portion.

[0022] When the clinician slides the control component proximally, the distal portion of the elongated component can deflect from its initial configuration to a deflected configuration. When the clinician releases the control component or pushes it distally back to its original position, the traction line actively pushes the elongated component back to its initial configuration. For example, the periphery of the traction line can be constrained to the control component from a fixed component at the distal portion of the elongated component. By constraining the traction line, the thrust applied to the traction line is transferred from the control component to the distal portion of the elongated component, rather than the unconstrained traction line bending or buckling in response to the thrust. This translation of the thrust by the constrained traction line allows the elongated component to actively return from the deflected configuration to its initial configuration, which can be a substantially straight configuration.

[0023] Compared to deflectable conduits without active return, the described deflectable conduit offers enhanced functionality by using a single traction line to achieve active return. For example, when the control component in the deflection configuration is released, a deflectable conduit without active return may relax back to the initial configuration due to strain release in the elongated component. In some instances, the return to the initial configuration may be due to elastic deformation of at least a portion of the elongated component. In some instances, a deflectable conduit without active return may not fully return to the initial configuration, for example, due to plastic deformation of at least a portion of the elongated component. However, an actively returning deflectable conduit can be controlled to return to the initial configuration. In some instances, an actively returning deflectable conduit may extend beyond the initial configuration, for example, by deflecting in a second direction opposite to the deflection configuration.

[0024] Figure 1 This is a schematic diagram and conceptual diagram illustrating a plan view of an example deflectable conduit 100. The deflectable conduit 100 includes an elongated member 102 and a deflection assembly 104. The elongated member 102 extends from a proximal end 106 to a distal end 108. The elongated member 102 includes a wall 110 defining a longitudinally extending lumen (not shown).

[0025] Wall 110 may include one or more layers of material. For example, wall 110 may include one or more layers of polymeric material. In some instances, wall 110 may include an elongated core layer, an inner layer, and an outer layer. The elongated core layer may include a material that is substantially elastic relative to the inner and / or outer layers. In some instances, the elongated core layer may include coiled or braided metal wires, such as stainless steel or nitinol, defining an outer and inner surface that define a lumen of the elongated member 102. The inner layer may include a polymer disposed on the inner surface of the elongated core layer, such as polytetrafluoroethylene or other polymers having a low coefficient of friction (e.g., relative to the elongated core layer). The outer layer may include a polymer disposed on the outer surface of the elongated core layer, such as polyether block amide or other flexible polymers.

[0026] The proximal portion (e.g., proximal end 106) of the elongated member 102 is coupled to a deflection assembly 104. The deflection assembly 104 includes a hub assembly (not shown), a handle 112, a control member 114, and a traction cable 126. The hub assembly may be coupled to at least a portion of the proximal portion 120 (e.g., proximal end 106) of the elongated member 102. For example, the hub assembly may be overmolded onto a portion of the proximal portion 120 of the elongated member 102. The handle 112 may be configured to surround and engage at least a portion of the hub assembly. Additionally or alternatively, at least a portion of the proximal portion 120 (e.g., proximal end 106) of the elongated member 102 may be directly coupled to the handle 112. The control member 114 may be slidably engaged with the handle 112. For example, the handle 112 may define a track 128 along which the control member 114 may move (e.g., in a proximal-distal direction).

[0027] The traction cable 126 extends from a proximal end 130 to a distal end 132. The proximal end 130 of the traction cable 126 may be coupled to a control component 114. In some instances, the deflection assembly 104 may include a thiouret (not shown) extending from the distal end of the thiouret directly coupled to the proximal end 130 of the traction cable 126 to the proximal end of the thiouret directly coupled to the control component 114. The traction cable 126 may extend through at least a portion of a hub assembly, handle 112, and / or wall 110, such as an elongated component 102. For example, the handle 112 may include a handle surround (not shown) configured to surround at least a portion of the traction cable 126 and / or thiouret extending from the hub assembly to the control component 114. The traction cable 126 may include any suitable non-stretchable and / or incompressible material. In some instances, the traction cable 126 may include a metal formed as an elongated wire, coil, or braid, such as stainless steel or nitinol.

[0028] The distal end 132 of the traction line 126 may be coupled (e.g., anchored) to the retaining member 122. The retaining member 122 may be coupled to the outer surface 124 of the wall 110 on the distal portion 116 of the elongated member 102. For example, the retaining member 122 may include one or more components configured to mechanically engage the traction line 126 to the distal portion 116 of the elongated member 102. In some instances, the retaining member 122 may include a collar, collet, compression fitting, or any suitable annular fitting that is overmolded or mechanically coupled (e.g., adhesive or friction fit) to the outer surface 124 of the wall 110 of the elongated member 102. Thus, the retaining member 122 may be configured to engage the outer surface 124 of the wall 110 of the elongated member 102. In some instances, the retaining member 122 may also include a channel or protrusion configured to receive the distal portion 132 of the traction line 126. In some instances, the distal end 132 of the traction line 126 may include anchors such as a ball structure (e.g., having a diameter larger than that of the traction line 126), a washer, a loop, or a knot to enable the fixing member 122 to securely hold the distal portion 132 of the traction line 126.

[0029] In some instances, the distal portion 116 of the conduit 100 (e.g., the distal tip 108) may include a distal cup 134. The distal cup 134 may extend from the retainer 122 to the distal tip 136. The distal cup 134 may be configured to surround at least a portion of the retainer 122. For example, the distal cup 134 may be overmolded onto at least a portion of the distal tip 132 of the retainer 122 and / or the elongated traction wire 126. In some instances, the distal cup 134 may comprise any suitable material, such as one or more polymers. At least one of the following conditions exists: the tensile strength of one or more polymers of the distal cup 134 may be greater than the tensile strength of the material of the elongated member 102, or the hardness of one or more polymers of the distal cup 134 may be greater than the hardness of the material of the elongated member 102. Thus, the distal cup 134 may comprise a polymer material that is tougher than the outer layer of the elongated member 102. For example, the relative toughness of the distal cup 134 can improve the strength of pulling and pushing on the traction line 126 compared to attaching the traction line directly to the elongated member 126 or embedding it in the elongated member 126.

[0030] In some instances, the distal cup 134 may be configured to receive an implantable medical device (IMD). For example, the distal cup 134 may be configured to receive an implantable electrotherapy device, such as a cardiac pacemaker. In some instances, the distal cup 134 may be configured to deploy the IMD. For example, a clinician may introduce the distal portion 116 of the elongated member 202 into a patient's vascular system. The clinician may guide the distal cup 134 to a target site within the patient's vascular system. The target site may include, for example, a target pacing site. Once located at the target site, the clinician may deploy the IMD from the distal tip 136 of the distal cup 134. For example, the deflectable catheter 100 may include any suitable deployment component configured to deploy the IMD from the distal tip 136 of the distal cup 134. In some instances, the deployment component may include a control line having a proximal end connected to the control component at the deflection assembly 104, a middle portion extending through the elongated component 102, and a distal end configured to push the IMD out of the distal cup-shaped component 134.

[0031] At least a portion of the distal portion 116 of the elongated member 102 is configured, for example, in the direction of arrow 118 from the initial configuration (e.g., as...). Figure 1 (As shown by the solid line in the image) deflect to a deflection configuration (e.g., as shown by the solid line in the image) Figure 1 (As shown by the dashed line in the diagram). The proximal portion 120 of the elongated member 102 can be configured not to deflect when the distal portion 116 deflects. As a clinician slides the control member 114 proximally, the distal portion of the elongated member 102 can deflect from the initial configuration to a deflection configuration, as indicated by arrow 138. In some instances, the initial configuration may include a substantially straight configuration, such as a straight or nearly straight configuration of the elongated member 102. In some instances, the initial configuration may include a zigzag configuration, for example, the elongated member 102 may define a bend or zigzag portion when in a relaxed state without applied traction or thrust. In some instances, the deflection configuration may include any suitable deflection relative to the initial configuration.

[0032] In some instances, deflection occurs on the distal portion of the elongated member 102 because the wall 110 of the elongated member 102 is more flexible or compressible along the distal portion 116 relative to the proximal portion 120. Typically, the deflection configuration can include any suitable radii and / or radius of curvature. In some instances, the radii of the deflection configuration can range from about 10 degrees to about 180 degrees, such as from about 20 degrees to about 90 degrees. In some instances, the deflection configuration can include two or more deflections in the same or different directions. The first deflection and the second deflection can be in the same or different longitudinal positions relative to the elongated member 102. For example, the deflection configuration may include a first deflection (e.g., in...) Figure 1(in the page plane shown) and a second deflection in the second direction at the same or different longitudinal positions (e.g., in) Figure 1 (Outside the page plane shown).

[0033] When a clinician releases control member 114 or pushes control member distally back to its original position, traction line 126 actively pushes elongated member 102 back to its initial configuration. For example, the periphery of traction line 126 can be constrained (e.g., wrapped around) control member 114 from fixation member 122 at the distal end 108 of elongated member 102. By constraining traction line 126, the thrust applied to traction line 126 can be transmitted from control member 114 to the distal portion 116 of elongated member 102, rather than an unconstrained traction line bending or buckling in response to thrust. The transmission of thrust through constrained traction line 126 enables elongated member 102 to actively return from deflection configuration to initial configuration. Compared to deflectable catheters without active return, the described deflectable catheter provides enhanced functionality by using a single traction line to achieve active return. For example, when control member is released in deflection configuration, deflectable catheters without active return may loosen to the initial configuration due to the release of strain or elastic deformation in the elongated member. In some instances, a deflectable conduit without active return may not be able to fully return to its initial configuration, for example, due to plastic deformation of at least a portion of the elongated component. However, the actively returning deflectable conduit 100 can be controlled to return to its initial configuration, as described above.

[0034] In some instances, the actively returning deflectable conduit can extend beyond its initial configuration, for example, by deflecting in a second direction opposite to the deflection configuration. In some instances, the deflection assembly 104 may include a damping component configured to dampen forces applied to the control component 114 in a distal, proximal, or both direction. This allows a clinician to move the control component distally back to its original position while the elongated component actively returns to its initial configuration at a slightly damped rate. In some instances, the damping component may include a spring positioned within a handle and mechanically coupled to the control component, such that the spring does not engage (under compression or tension) when the control component is pulled proximally, but engages under compression (e.g., to act as a shock absorber) when the control component is pushed distally. In some instances, the spring may also provide some active straightening.

[0035] Figure 2A and 2B This is a conceptual diagram illustrating the transverse and axial cross-sectional views of example conduit 200. Conduit 200 can be referenced above. Figure 1The deflectable conduit 100 described herein is identical or substantially similar, except for the differences described herein. Conduit 200 includes an elongated component 202, a distal fixation component 204, a proximal fixation component 206, and a traction wire 208. The distal fixation component 204 and the proximal fixation component 206 are configured to cover a molded cup at the distal end of conduit 200 and a molded hub at the proximal end of conduit 200. For example, without the distal fixation component 204 and the proximal fixation component 206, covering the conduit 200 with a molded cup and hub may compress or deform the conduit 200. In some instances, the distal fixation component 204 and the proximal fixation component 206 can be molded onto the conduit 200 using a lower pressure than the high-pressure covering molding of the cup and hub. In some instances, the proximal fixation member 206 may include a collar that allows the molding traction line 208 (or sacrificial line) to be wrapped so that the line can extend out of the wrapped molding die without the wrapped molding material being discharged from the die.

[0036] An elongated member 202 extends from a proximal end 210 to a distal end 212. As described above, the elongated member 202 can be configured to deflect from an initial configuration to a deflection configuration in response to a traction force applied to the traction line 208 (e.g., in the proximal direction), and to actively return from the deflection configuration to the initial configuration in response to a thrust applied to the traction line 208 (e.g., in the distal direction). The elongated member includes a wall 214 defining a longitudinally extending lumen 216. As described above, the wall 214 can include an elongated core layer 218, an inner layer 224, and an outer layer 226. The elongated core layer 218 defines an outer surface 220 and an inner surface 222. The inner surface 222 can define the longitudinally extending lumen 216. The inner layer 224 can be disposed on the inner surface 222 of the elongated core layer 218. The outer layer 226 can be disposed on the outer surface 220 of the elongated core layer 218. In some instances, the traction wire 208 may extend from the proximal end 210 of the elongated member 202 through the inner layer 224 to the distal end 212. In some instances, the traction wire 208 may extend through a separate dedicated lumen between the inner layer 224 and the core layer 218. In some instances, the traction wire 208 may extend through both the proximal fixation member 206 and the distal fixation member 204.

[0037] The distal retaining member 204 is coupled to the outer surface 228 of the wall 214 on the distal portion 230 of the elongated member 202. The distal retaining member 204 may include at least one collar or clamp configured to engage the outer surface 228 by at least one of a friction fit, a compression fit, or another mechanical fit, such as by adhesive or overmolding. The distal retaining member 204 is configured to engage the distal end 232 of the traction line 208. For example, the distal retaining member 204 may define a distal retaining channel 234 through which the traction line 208 extends in a slidably engaged manner. In some instances, the distal end 232 of the traction line 208 may define or include a spherical structure (e.g., a structure with a diameter larger than that of the traction line 208), a washer, a loop, or a knot. Thus, when traction is applied to the traction line 208 (e.g., in the proximal direction), the distal end 232 can transmit the traction force to the distal retaining member 204 and the elongated member 202. In some instances, a distal cupping element (e.g., distal cupping element 134) may be coupled to the distal end 232 of the distal fixation member 204 and the traction line 208. The distal cupping element may be configured to transmit thrust from the distal end 232 to the distal cupping element, the distal fixation member 204, and the elongated member 202 when thrust is applied to the traction line 208 (e.g., in the distal direction). Thus, the distal end of the conduit 200 is configured to transmit thrust and traction through a single traction line 208 to achieve deflection and active return of the elongated member 202.

[0038] The proximal retainer 206 is coupled to the outer surface 228 of the wall 214 of the elongated member 202 at the proximal portion 236 (e.g., the proximal end 238). The proximal retainer 206 may include at least one collar or clamp configured to engage the outer surface 228 of the wall 214 of the elongated member 202 by at least one of a friction fit, a compression fit, or another mechanical fit, such as by adhesive or overmolding. The proximal retainer 206 may be configured to retain the traction wire 208 in a sliding engagement. For example, the proximal retainer 206 may define a proximal retention channel 240 configured to retain the traction wire 208 in a sliding engagement. In some instances, the proximal retainer 206 may be configured to deflect the traction wire 208 away from a longitudinal axis 242, along which the elongated member 202 extends, for example. For example, the proximal fixation member 206 may include a retaining arm 244 extending from the proximal fixation member 206 (e.g., a collar or clamp of the proximal fixation member 206). The retaining arm 244 may be integrally formed with the proximal fixation member 206 or fixed to the proximal fixation member 206 by, for example, an adhesive. The retaining arm 244 may include a retaining channel 246 extending at an angle θ relative to the longitudinal axis 242 of the elongated member 202 from its distal end 248 to its proximal end 250. In some instances, the proximal end 250 may define a collar. The retaining channel 246 may be configured to retain the traction cable 208 in a sliding engagement. In this way, the proximal fixation member 206 can orient the traction cable 208 away from the elongated member 202 such that the proximal end of the traction cable 208 can be coupled to a control member of the deflection assembly (e.g., a control member 114 of the deflection assembly 104).

[0039] In some instances, the proximal retainer 206 may also include an outer rim 252. In some instances, the outer rim 252 is not attached to the proximal end 250. For example, the proximal end 250 may include a collar such that both the proximal end collar 250 and the outer rim 252 can be placed in a mold for overmolding. When the hub is overmolded onto the proximal retainer 206, the outer rim 252 may allow the proximal end collar 250 to seal (e.g., prevent overmolding material from escaping from the mold) while the traction line 208 (or sacrificial line) can extend through a hole in the mold. After the overmolded proximal retainer 206 has cooled, the sacrificial line can be pulled out, leaving a retention channel 246. In some instances, the final traction line 208 has a smaller diameter than the sacrificial line and can be inserted through the distal end of the conduit 200 and extend beyond the outer rim 252. Alternatively, the outer rim rim 252 may be coupled to the retention arm 244, for example, by mechanical interlocking or adhesive. The outer rim 252 may include an outer rim channel 254. The outer rim channel 254 may extend from its distal end to its proximal end at an angle θ relative to the longitudinal axis 242 of the elongated member 202. In other embodiments, the outer rim channel 254 may extend at an angle different from that of the retaining arm channel 246. The outer rim 252 may be configured to retain the traction line 208 in a sliding engagement. The outer rim may allow the hub assembly to be overmolded onto the conduit 100, thereby fluidly isolating the traction line 208 from the lumen 216. Thus, the conduit 200 may include a leak-proof or leak-resistant traction line assembly.

[0040] The distal fixation member 204 and the proximal fixation member 206 may comprise any suitable material. In some instances, the distal fixation member 204 and / or the proximal fixation member 206 may comprise a thermoplastic polymer. For example, the distal fixation member 204 and / or the proximal fixation member 206 may be overmolded onto the respective distal portion 230 or proximal portion 236 of the elongated member 202. In some instances, the distal fixation member 204 and / or the proximal fixation member 206 may be overmolded around a traction wire 208 or around a sacrificial wire, which may be replaced with the traction wire 208 after the proximal fixation member 206 has been overmolded.

[0041] The traction line 208 can be referenced above. Figure 1 The traction wires 126 discussed are the same or substantially similar. For example, traction wire 208 extends from the proximal end 238 of the elongated member 202 through the wall 214 of the elongated member 202 to the distal fixing member 204, and traction wire 208 can be coupled to the distal fixing member 204. Traction wire 208 can extend through the inner layer 224 or be disposed between the inner layer 224 and the core layer 218. In some instances, such as... Figure 2AAs shown, the traction wire 208 may protrude through the outer layer 226 at the proximal end 238 of the elongated member 202. In other embodiments, the traction wire 208 may protrude through the core layer 218 and the outer layer 226 to the outer surface 228 of the wall 214 at the proximal portion 236 of the elongated member 202 (e.g., at a location away from the proximal end 238 of the elongated member 202). In some embodiments, the traction wire 208 may include a sheath or tube surrounding at least a portion of the traction wire 208.

[0042] Figure 3A and 3B This is a photograph illustrating the distal fixation member 306 on the distal end 304 of the elongated component 302 of the example conduit 300. The conduit 300 can be referenced above. Figures 1 to 2B The catheters 100 and 200 discussed are identical or substantially similar. As described above, the distal fixation member 306 is coupled to the distal portion 308 of the elongated body 302. The distal fixation member 306 includes a fixation arm 310 to which a traction wire 312 can be coupled. For example, the traction wire 312 includes two loops surrounding a portion of the fixation arm 310. In some instances, at least the distal portion of the traction wire 312 can be encapsulated within the fixation arm 310; for example, the distal fixation member 306 can be overmolded onto at least the distal portion of the traction wire 312. By surrounding this portion of the fixation arm 310, the traction wire 312 can transmit traction and / or thrust to the fixation member 306 and the elongated body 302, as referenced above. Figures 1 to 2B As stated above.

[0043] Figure 4 These are conceptual and schematic diagrams illustrating different configurations of the distal ends 406A, 406B, 406C, and 406D of the respective elongated components 402A, 402B, 402C, and 402D of the respective conduits 400A, 400B, 400C, and 400D, and the distal ends 410A, 410B, 410C, and 410D of the respective traction lines 408A, 408B, 408C, and 408D protruding from the respective distal ends 406A, 406B, 406C, and 406D of the respective traction lines 408A, 408B, 408C, and 408D. The conduit 400 can be referenced above. Figures 1 to 3B The catheters 100, 200, and 300 discussed are any one or more identical or substantially similar. Figure 4As shown, distal end 410A includes a double loop having a center of mass substantially aligned with the axis of traction line 408A. Distal end 410B includes a reverse knot. In other instances, the distal end may include other types of knots. Distal end 410C includes a double loop having a center of mass offset from the axis of traction line 408C. Distal end 410D includes spherical structures such as welded metal beads and washers. Any distal end 410 of traction line 408 may also contain welds or adhesives to enhance strength. As discussed above, distal ends 410A, 410B, 410C, and 410D are configured to engage a retaining member and / or a distal cup (e.g., overlaying a portion of a molded distal cup) to enable the respective traction lines 408A, 408B, 408C, and 408D to transmit thrust and / or traction to the respective elongated members 402A, 402B, 402C, and 402D.

[0044] Figures 5A to 5D This is a conceptual and schematic diagram illustrating the distal cup-shaped member 504 of the distal end 506 of the elongated component 502 connected to the example conduit 500. For illustrative purposes, the distal cup-shaped member 504 is shown as a transparent polymer, and... Figure 5C and 5D Partial resection of the middle section. The 500 catheter can be referenced above. Figures 1 to 4 Any one or more of the catheters 100, 200, 300, and 400 discussed are identical or substantially similar. For example, a distal cup 504 may be configured to receive an implantable medical device 512. In some instances, the distal cup 504 may be overmolded onto the distal end 506 of the distal fixation member 508 and the elongated member 502. By overmolding the distal cup 504 onto the distal end 506 of the distal fixation member 508 and the elongated member 502, the distal cup 504 may surround the fixation arm 510 of the distal fixation member 508 to securely retain the distal end 514 of the traction cable 516. Securely retaining the distal end 514 of the traction cable 516 allows the traction cable 516 to transmit thrust and / or traction force to the elongated member 502.

[0045] Figure 6 This is a photograph illustrating the proximal fixation member 606 on the proximal end 604 of the elongated component 602 of the example catheter 600. The catheter 600 can be referenced above. Figures 1 to 5DAny one or more of the catheters 100, 200, 300, 400, and 500 discussed are identical or substantially similar. As described above, the proximal fixation member 606 is coupled to the proximal end 604 of the elongated member 602. The proximal fixation member 606 may define a proximal retention channel configured to retain the traction cable 616 in a sliding engagement and includes a retention arm 608. The retention arm 608 extends from the proximal fixation member 606 (e.g., a collar or clamp of the proximal fixation member 206). The retention arm 608 may include a retention channel 610 extending at an angle relative to the longitudinal axis of the elongated member 602 from its distal end 612 to its proximal end 614. The retention channel 610 may be configured to retain the traction cable 616 in a sliding engagement. In this way, the proximal fixing member 606 can orient the traction line 616 away from the elongated member 602, so that the proximal end of the traction line 208 can be connected to the control member of the deflection assembly (e.g., the control member 114 of the deflection assembly 104).

[0046] As described above, in some instances, distal fixation components and / or proximal fixation components can be molded onto elongated components using traction wire wrapping. Figure 7A and 7B It illustrates how to use such Figure 6 A photograph of an example mold 700, showing the proximal fixation member 704 of the proximal fixation member 606 overmolded onto the elongated member 702 of the example conduit 700. The first half of the mold 700 is... Figure 7A and 7B As shown in the figure. A second half of the mold (not shown) is configured to engage with the first half of the mold to overmold the proximal retaining member 704 onto the elongated member 702. The mold 700 may include a mold region 706 of a selected shape corresponding to the proximal retaining member 704 and one or more channels 708 configured to guide injected flowable polymer into the mold. In some instances, the mold 700 may include a pin 710 configured to engage within a lumen defined by the elongated member 702. When flowable polymer is injected into the mold region 706, the pin 710 may reduce deformation of the elongated member 702, such as collapse of the lumen. The mold 700 also defines a traction line channel 712 configured to receive a traction line extending from the proximal end of the elongated member 702. The traction line channel 712 may extend at an angle from the longitudinal axis of the elongated member 702.

[0047] As described above, the catheter may include an outer rim surround that allows the hub assembly to cover at least a portion of the proximal portion (e.g., the proximal end) of the elongated part of the catheter, such that the traction line of the catheter can be isolated from the fluid in the lumen of the catheter. Figures 8A to 8CThis is a photograph illustrating an example hub assembly 802 and an example outer rim surround 804 of the conduit 800. The conduit 800 can be referenced above. Figures 1 to 7B The conduits 100, 200, 300, 400, 500, 600, and 700 discussed are all identical or substantially similar. The hub assembly 802 may be overmolded onto the proximal portion 806 of the elongated member 808. In some instances, a handle of the deflection assembly may be configured to surround and engage at least a portion of the hub assembly 802. The hub assembly 802 may define a lumen 810 fluidly connected to a lumen of the elongated member 808. In some instances, the hub assembly 802 may also define a flushing port 812.

[0048] In some instances, the outer rim 804 may be coupled to the proximal retaining member 814 (e.g., the proximal retaining member 814 is coupled to the proximal end 806 of the elongated member 808). For example, the outer rim rim 804 may be coupled to the retaining arm of the proximal retaining member 814. Figure 8B As shown, the outer rim 804 may include an outer rim channel 816 extending from the distal end 822 to the proximal end 824 and an alignment hole 823. The outer rim channel 816 may be configured to hold the traction line 820 in a sliding engagement and to reduce or prevent fluid flow through the outer rim channel 816 when the traction line 820 is positioned within the outer rim channel 816. The alignment hole 823 may be used to align and secure the outer rim 804 during overmolding. Additionally or alternatively, when the hub 802 is overmolded onto the proximal retainer 814, thermoforming molding material is attached to the elongated member 808 and / or the proximal retainer 814 and surrounds the traction line 820. When the hub 802 is overmolded, the retaining arm collar (e.g., proximal end collar 250) and the outer rim 804 may prevent thermoforming molding material from escaping from the mold. Figure 8C As shown in the enlarged view, the outer rim channel 816 may extend at an angle θ relative to the longitudinal axis 818 of the elongated member 808. The outer rim rim 804 allows the hub assembly 802 to be molded over the proximal portion 806 of the elongated member 808, thereby fluidly isolating the traction line 808 from the lumen 810. Thus, the conduit 800 may include a leak-proof or leak-resistant traction line assembly. In some instances, a sacrificial line may be used during molding and then replaced with the final traction line. This facilitates manufacturing and improves the ease of movement of the traction line.

[0049] As described above, the deflection assembly of a deflectable catheter may include a handle configured to surround and engage at least a portion of the hub assembly, enabling the clinician to manipulate the deflectable catheter. Figures 9A to 9F The images depict photographs and concept diagrams of an example handle 912 of the deflection assembly 904 of the conduit 900. The conduit 900 can be referenced above. Figures 1 to 8C The catheters discussed are any one or more identical or substantially similar to those in the series 100, 200, 300, 400, 500, 600, 700, and 800. Figure 9A and 9B As shown, the handle 912 may include a first portion 916 and a second portion 918. The first portion 916 and the second portion 918 of the handle 912 are configured to be mechanically coupled to surround at least a portion of the hub assembly 920. The deflection assembly 904 also includes a control member 914. The control member 914 may be slidably engaged with the handle 912. For example, the handle 912 may define a track 928 along which the control member 914 may move (e.g., in a proximal-distal direction). In some instances, the control member 914 may be coupled to the traction line 926 via a traction block 941.

[0050] like Figures 9C to 9F As shown, the traction line 926 can be connected to the control unit 914 via the throttle tube 932 and the traction block 941. For example, the deflection assembly 904 includes the throttle tube 932 extending from the distal end 934 to the proximal end 936. Figure 9F As shown, the traction cable 926 may extend into or through the lumen 931 of the thiocyanate tube 932. In some embodiments, the thiocyanate tube 932 may be coiled onto at least a portion of the traction cable 926 to mechanically connect the thiocyanate tube 932 to the traction cable 926. In some embodiments, the distal end 934 of the thiocyanate tube 932 may be directly connected to the proximal portion of the traction cable 926 (e.g., proximal end 930). In some embodiments, the thiocyanate tube 932 may be bent approximately 90 degrees to mate with the longitudinally extending traction cable 926 and the control component 914 traveling longitudinally along the handle 912.

[0051] In some instances, the thiouret tube 932 can be substantially rigid compared to the traction line 926. For example, the thiouret tube 932 can be rigid enough that, in response to a thrust or traction force applied to the control element 914 by a clinician, the thiouret tube 932 travels in a proximal-distal direction with the control element 914, rather than deflecting or bending, for example, in response to a traction or thrust force. The thiouret tube 932 comprises any suitable material, such as stainless steel, nitinol, or medical-grade alloys.

[0052] The proximal end 936 of the submersible tube 932 and / or the proximal end 930 of the traction line 926 can be directly connected to the traction block 941. The gap pocket 940 of the control component 914 allows the control component 914 to move up and down independently of the submersible tube 932. Thus, the control component 914 is connected to the traction line 926 to transmit traction and / or thrust to the submersible tube 932 and the traction line 926.

[0053] The handle 912 is configured to constrain the traction line 926, such that the thrust applied to the traction line 926 by the control member 914, for example via the thallium tube 932, is transmitted along the longitudinal axis of the traction line 926, rather than causing the traction line 926 to bend or twist. The constraint of the traction line 926 may include multiple constraint regions. For example, such as... Figure 9F As shown, the first constraint region 950 may include the lumen 931 of the hyaluronic acid tube 932. As described above, the hyaluronic acid tube 932 may be coiled onto a portion of the traction cable 926 to support the traction cable 926 and allow the proximal end 930 of the traction cable 926 to be anchored to the control member 914. The second constraint region 952 may include a handle surround 954. The handle surround 954 may include a channel or tunnel through which the traction cable 926 and / or the hyaluronic acid tube 932 can freely pass. For example, a first portion 916 and a second portion 918 of the handle 912 may be configured to engage to define the handle surround 952. The third constraint region 956 may include a proximal fixation member 922 (e.g., including a retaining arm 923) and an outer rim surround 924. As described above, the proximal fixation member 922 and the outer rim surround 924 may define at least a portion of the region where the traction cable 926 extends through the wall 910 of the elongated member 902 and connects between the hyaluronic acid tubes 932. For example, the proximal fixing member 922 can extend from the traction line 926 through the wall 910 of the elongated body 902 to a point surrounding the traction line 926 in the outer rim surround 924. The outer rim surround 924 can mold the hub assembly 920 and the traction line into the hyaluronic acid tube. Thus, the first constraint 950, the second constraint 952, and the third constraint 956 enable the elongated tube 902 to actively return.

[0054] In some instances, the deflection assembly of the deflectable conduit may include a damping component configured to dampen the force applied to the control component 114 in the distal, proximal, or both directions. Figures 10A to 10B This is a conceptual diagram illustrating an example of a deflectable conduit 1000 having a deflection assembly 1004 including a damping component 1060. The conduit 1000 can be referenced above. Figures 1 to 9F The catheters discussed are any one or more identical or substantially similar to those in the series 100, 200, 300, 400, 500, 600, 700, 800, and 900. Figure 10AAs shown in the exploded view, the deflection assembly 1004 includes a handle 1012, a strain relief component 1013, a control component 1014, a hub assembly 1020, and a damping component 1060. The handle 1012 includes a first portion 1016 and a second portion 1018 configured to be mechanically coupled to surround at least a portion of the hub assembly 920, for example, defining a handle surround. The strain relief component 1013 may be configured to be coupled to the first portion 1016 and the second portion 1018 of the handle 1012 and at least a portion of the elongated component 1002, enabling the handle 1012 to transmit movement of the handle 1012 to the elongated component 1002, such as torque or proximal-distal movement of the handle 1012. As described above, the handle 1012 may be coupled to the hub assembly 1020. A traction cable 1026 may be coupled to a threshold tube 1032, which is configured to be coupled to the control component 1014.

[0055] Damping member 1060 is configured to dampen forces applied to control member 1014 in a distal, proximal, or both direction. Damping member 1060 may include an outer traction block 1062, an inner traction block 1064, and a spring 1066. Outer traction block 1062 may be configured to be coupled to control member 1014. Outer traction block 1062 may slidably engage with track 1028 defined by handle 1012. For example, when a clinician moves control member 1014 in a proximal-distal direction, outer traction block 1062 may move with control member 1014 (e.g., in the same direction and distance). Outer traction block 1062 may define track 1068 that slidably engages with inner traction block 1064. Inner traction block 1064 may be coupled to thiopancreatography (THB) tube 1032, which is coupled to traction line 1026. Figure 10B As shown, when the control member 1014 moves in the proximal direction, the distal surface 1070 of the inner traction block 1064 can contact the distal wall 1072 of the outer traction block 1062. Thus, when the control member 1014 moves in the proximal direction, the inner traction block 1064 can move together with the outer block 1062. Figure 10CAs shown, when the control member 1014 moves in the distal direction (e.g., actively returns), the inner traction block 1064 can resist movement relative to the outer traction block 1062, such that movement of the control member 1014 and the outer traction block 1062 in the distal direction may cause compression of the spring 1066. Thus, when the control member 1014 is pulled proximally, the spring 1066 is not engaged (under compression or tension), but when the control member 1014 is pushed distally, the spring 1066 engages under compression (e.g., as a shock absorber). Once the compressive force of the spring 1066 exceeds the force required for the elongated member 1002 to actively return (or once the proximal end of the inner traction block 1064 contacts the proximal wall of the outer traction block 1062), thrust can be transmitted from the control member 1014 to the outer traction block 1062, and through the spring 1066 and the inner traction block 1064 to the submersible 1032 and the traction line 1026. Thus, the conduit 1000 can be configured to dampen the thrust applied to the control member 1014 during the active retraction of the elongated member 1002. In some instances, the spring can also provide some active straightening. Without the spring 1066, the conduit can function without active straightening.

[0056] The catheters described in this article can be manufactured using any suitable technology. Figure 11 This is a flowchart illustrating an example method for manufacturing an elongated component of a deflectable conduit. (Although references are available...) Figure 2A and 2B The catheter 200 shown describes Figure 11 The technology shown is applicable to the manufacture of other catheters, such as catheters 100, 300, 400, 500, 600, 700, 800, 900, and / or 1000. Additionally, catheters 100, 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000 can be manufactured using other technologies.

[0057] Figure 11 The illustrated technique includes forming an elongated component 202 (1106). Forming the elongated component may include, for example, positioning an inner layer 224 on a mandrel, positioning a sacrificial traction wire on the inner layer 224, positioning a tubular component on the sacrificial traction wire and the inner layer 224, positioning a core layer 218 on the tubular component, and positioning an outer layer 226 on the core layer 218. As described above, the inner layer 224 may comprise any suitable polymer, such as polytetrafluoroethylene. As described above, the outer layer 226 may comprise any suitable polymer, such as polyether block amide.

[0058] In some instances, positioning the core layer 218 may include braiding two or more metal wires onto a mandrel. In some instances, forming the core layer 218 may include forming the core layer 218 directly on the inner layer 224. In some instances, forming the elongated core layer 218 may include grinding or coating the inner surface of the outer surface of the elongated core layer 218 before depositing the inner layer 224 or the outer layer 226 onto the respective surface.

[0059] In some instances, the technique may include depositing a polymer onto the inner surface 222 of the core layer 218 to form the inner layer 224, rather than positioning the core layer 218 on the inner layer 224. Any suitable deposition or coating method may be used to deposit the inner layer 224. In some instances, the inner layer 224 may be deposited onto a mandrel prior to forming the elongated core layer 218 on the inner layer 224. In some instances, the traction wire 208 (or sacrificial wire) may be positioned adjacent to the inner surface 222 of the core layer 218 prior to the deposition of the inner layer 224, such that the inner layer 224 substantially surrounds the traction wire 208.

[0060] In some instances, the technique may include depositing a polymer onto the outer surface 220 of the core layer 218 to form an outer layer 226, rather than positioning the outer layer 226 on the core layer 281. Any suitable deposition or coating method may be used to deposit the outer layer 226. The outer layer 226 may at least partially flow into the spaces between the filaments of the core layer 218.

[0061] Figure 11 The illustrated technique includes overmolding the proximal retaining member 206 onto the proximal portion 236 of the elongated member 202 (1108). In some instances, the proximal retaining member 206 (e.g., retaining arm 244) may be overmolded to surround at least a portion of the traction line 208. In some instances, the technique may include attaching an outer rim 252 to the retaining arm 244. In some instances, the technique may also include overmolding a hub assembly onto the proximal retaining member 206 and / or the proximal portion 236 of the elongated member 202, thereby surrounding the traction line 208. In instances where the inner layer 224 is deposited on the sacrificial line, the technique may include overmolding the proximal retaining member 206 afterward, and in some instances, the traction line 208 is used instead of the sacrificial line in the hub assembly 802. In some instances, after the sacrificial line is removed, for example by pulling, the proximal end of the traction line 208 can be screwed into the inner layer 224 at the distal end 212 of the elongated body 202. In some instances, the distal end 232 of the traction line 208 may include a spherical structure anchorable to the distal fixing member 204.

[0062] Figure 11The illustrated technique includes overmolding a distal retaining member 204 onto the distal portion 230 of the elongated member 202 (1110). In some instances, the distal retaining member 204 may be overmolded to surround at least a portion of the distal end 232 of the traction line 208. In some instances, before or after overmolding the distal retaining member 204, the technique may include knotting, looping, and / or welding a spherical structure to the distal end 232 of the traction line 208. In some instances, the technique may also include overmolding a distal cup-shaped member onto the distal retaining member 204 and / or the distal portion 230 of the elongated member 202.

[0063] Figure 12 This is a flowchart illustrating an example method for manufacturing a deflectable assembly of a deflectable conduit. (Although references are available...) Figures 9A to 9F The catheter 900 shown describes Figure 12 The technology shown is applicable to the manufacture of other catheters, such as catheters 100, 200, 300, 400, 500, 600, 700, 800, and / or 1000. Additionally, catheters 100, 300, 400, 500, 600, 700, 800, 900, and / or 1000 can be manufactured using other technologies.

[0064] Figure 12 The illustrated technique involves attaching the thiocyanate tube 932 to the traction cable 926 (1202). For example, the traction cable 926 may be positioned within the lumen 931 of the thiocyanate tube 932, and then the thiocyanate tube 932 may be coiled to mechanically attach the thiocyanate tube 932 to the traction cable 926. In other embodiments, the traction cable 926 may be adhered to the thiocyanate tube 932, for example, using epoxy resin or other suitable adhesives or solder.

[0065] Figure 12 The illustrated technique includes coupling the control component 914 to the hysteresis tube 932 (1204). For example, the hysteresis tube 932 may be mechanically coupled to a molded fitting defined by the control component 914, or adhered to the control component 914, for example, using epoxy resin or another suitable adhesive. In examples where the conduit includes a damping component, the technique may include assembling the damping component 1060, coupling the inner traction block 1064 to the hysteresis tube 1032, and coupling the outer traction block 1062 to the control component 1014.

[0066] Figure 12 The illustrated technique includes positioning an elongated member 902 and / or a hub assembly 920 on a first portion 916 (1206) of a handle 912. The technique also includes attaching a second portion 918 of the handle 912 to the first portion 916 (1208).

[0067] The catheter described in this article can be used to deliver implantable medical devices to target sites within a patient's body. Figure 13 This is a flowchart illustrating an example method using a deflectable conduit. (Although references are available...) Figure 1 The catheter 100 shown describes Figure 13 The technology shown is applicable, but it can be used with other catheters, such as catheters 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000. Additionally, catheters 100, 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000 can be used with other technologies.

[0068] Figure 13 The technique shown involves introducing the distal portion 116 of the elongated body 102 of catheter 100 into the patient's vascular system (1302). In some instances, introducing catheter 100 may include forming an incision in the patient's femoral vein.

[0069] After catheter 100 is introduced, the technique may include guiding catheter 100 to a target chamber of the patient's heart. In some instances, guidance may include using fluoroscopy to visualize the position of catheter 100 relative to the patient's anatomy. Guiding catheter 100 includes controlling catheter 100 to deflect from an initial configuration to a deflection configuration (1304), and controlling catheter 100 to actively return from the deflection configuration to the initial configuration (1306). The technique may also include deploying an IMD from the distal cupping element 134 of catheter 100 to a target location within the patient's vascular system.

[0070] The following clauses illustrate the example topics described in this article.

[0071] Clause 1. A catheter comprising: an elongated portion extending from a proximal end to a distal end, wherein the elongated portion includes a wall defining a longitudinally extending lumen; a fixation member coupled to an outer surface of the wall at a distal portion of the elongated portion; and a traction wire extending through the wall of the elongated portion from the proximal end of the elongated portion to the fixation member, wherein the traction wire is coupled to the fixation member, and wherein the elongated portion is configured to deflect from an initial configuration to a deflected configuration in response to a traction force applied to the traction wire.

[0072] Clause 2. The catheter of claim 1, wherein the elongated member is further configured to deflect from the deflection configuration to the initial configuration in response to a thrust applied to the traction line.

[0073] Clause 3. The catheter according to claim 1 or 2, wherein the traction line extends from the proximal end of the elongated member through at least a portion of the wall of the elongated member to the fixation member.

[0074] Clause 4. The catheter according to any one of claims 1 to 3, wherein the wall comprises: an elongated core layer defining an outer surface and an inner surface, the outer surface and the inner surface defining the longitudinally extending lumen; an inner layer disposed on the inner surface of the elongated core layer; and an outer layer disposed on the outer surface of the elongated core layer, wherein the traction wire is disposed between the inner layer and the core layer or passes through at least one of the inner layers.

[0075] Clause 5. The catheter of claim 4, wherein the elongated core layer comprises coiled or braided metal wire.

[0076] Clause 6. The catheter according to claim 4 or 5, wherein the traction wire passes through the core layer and the outer layer and protrudes to the outer surface of the outer layer at the proximal portion of the elongated member.

[0077] Clause 7. The catheter according to any one of claims 1 to 6, wherein the fixing member comprises at least one of a collar or a clamp, the collar or the clamp being configured to engage the outer surface of the wall of the elongated member by at least one of friction fit, compression fit or overmolding, and to connect to the distal end of the traction line.

[0078] Clause 8. The conduit according to any one of claims 1 to 7, wherein the distal end of the traction line comprises at least one of a spherical structure, a loop, a knot, a weld, or a gasket.

[0079] Clause 9. The catheter according to any one of claims 1 to 8, wherein the distal end of the catheter includes a distal cup-shaped member extending from the fixation member to the distal tip of the distal cup-shaped member, wherein the distal cup-shaped member surrounds at least one of at least a portion of the fixation member or at least a portion of the distal end of the elongated traction wire.

[0080] Clause 10. The catheter of claim 9, wherein the elongated member comprises a first polymer, wherein the distal cup-shaped member comprises a second polymer, and wherein at least one of the following conditions exists: the tensile strength of the second polymer is greater than the tensile strength of the first polymer, or the ductility of the first polymer is greater than the ductility of the second polymer.

[0081] Clause 11. The catheter according to any one of claims 1 to 10, wherein the fixing member comprises a first fixing member, and the catheter further comprises a second fixing member, the second fixing member being coupled to the outer surface of the wall at the proximal end of the elongated member.

[0082] Clause 12. The catheter of claim 11, wherein the second fixing member comprises: at least one of a collar or a clamp configured to engage the outer surface of the wall of the elongated member by at least one of a frictional engagement or a compression engagement; and a channel configured to hold the traction line in a sliding engagement.

[0083] Clause 13. The catheter of claim 12, wherein the second fixation member further comprises a retaining arm extending from the collar or the clamp, the retaining arm comprising a retaining channel extending from its distal end to its proximal end at an angle away from the longitudinal axis of the elongated member, wherein the retaining channel is configured to retain the traction line in a sliding engagement.

[0084] Clause 14. The catheter of claim 13, wherein the second fixation member further comprises an outer circumference coupled to the retaining arm, the outer circumference comprising an outer circumference channel configured to retain the traction line in a sliding engagement, wherein the outer circumference channel extends from its distal end to its proximal end at an angle away from the longitudinal axis of the elongated member.

[0085] Clause 15. The conduit according to any one of claims 1 to 14, wherein the conduit further comprises an overmolded hub assembly that at least surrounds the proximal portion of the elongated member.

[0086] Clause 16. The conduit of claim 15, wherein the overmolded hub assembly surrounds at least a portion of the second fixing member and at least a distal portion of the outer rim surround.

[0087] Clause 17. A catheter comprising: an elongated portion extending from a proximal end to a distal end, wherein the elongated portion includes a wall defining a longitudinally extending lumen; a distal fixation portion coupled to an outer surface of the wall at a distal portion of the elongated portion; a proximal fixation portion coupled to an outer surface of the wall at a proximal portion of the elongated portion; a retaining arm integrally formed with the proximal fixation portion, wherein the retaining arm is configured to retain a traction line in sliding engagement at an angle extending away from the longitudinal axis of the elongated portion; and a traction line extending through the wall of the elongated portion from the distal end coupled to the distal fixation portion to a distal portion extending through the proximal fixation portion and the retaining arm, wherein the elongated portion is configured to deflect from an initial configuration to a deflected configuration in response to a traction force applied to the traction line.

[0088] Clause 18. A method comprising: forming an elongated member extending from a proximal end to a distal end, wherein the elongated member includes a wall defining a longitudinally extending lumen; overmolding a retaining member onto an outer surface of the wall on a distal portion of the elongated member; and anchoring a traction wire to the retaining member, wherein the traction wire extends from the proximal end of the elongated member through the wall of the elongated member to the retaining member, and wherein the elongated member is configured to deflect from an initial configuration to a deflected configuration in response to a traction force applied to the traction wire.

[0089] Clause 19. The method of claim 18, wherein forming the elongated member comprises: positioning the traction wire adjacent to an outer surface of an elongated core layer of the elongated member; and forming an outer layer on the outer surface of the elongated core layer, wherein the traction wire extends from a proximal end of the elongated member through the outer layer to the fixing member.

[0090] Clause 20. The method of claim 18 or 19, wherein anchoring the traction line to the fixing member comprises at least one of: knotting or looping the distal end of the traction line, welding a spherical structure to the distal end of the traction line, or overmolding the fixing member to surround the distal end of the traction line.

[0091] Clause 21. The method of any one of claims 18 to 20, wherein anchoring the traction line to the fixing member comprises molding a distal cup-shaped member over a portion of the fixing member, a distal end of the traction line, or a distal end of the elongated member.

[0092] Clause 22. The method of any one of claims 18 to 21, wherein the fixing member comprises a first fixing member, and wherein the method further comprises overmolding a second fixing member onto the outer surface of the wall at the proximal end of the elongated member to surround at least a portion of the traction line.

[0093] Clause 23. The method of claim 22 further comprises: attaching the outer rim surround to the second fixing member; and overmolding the hub assembly onto at least one of the proximal portion of the second fixing member, the distal portion of the outer rim surround, or the proximal portion of the elongated member.

[0094] Clause 24. The method of any one of claims 18 to 23, wherein the elongated member is configured to deflect from the deflection configuration to the initial configuration in response to a thrust applied to the traction line.

[0095] Various examples of this disclosure have been described. Consider any combination of the described systems, operations, or functions. These and other examples are within the scope of the following claims.

Claims

1. A catheter comprising: An elongated member extending from a proximal end to a distal end, wherein the elongated member includes a wall defining a longitudinally extending lumen; A first fixing component is attached to the distal portion of the elongated component; A second fixing component is attached to the outer surface of the wall at the proximal end of the elongated component; An overmolded hub assembly, the overmolded hub assembly at least surrounding the proximal portion of the elongated member, wherein the overmolded hub assembly surrounds at least a portion of the second fixing member and at least the distal portion of the outer edge surround; and A traction line extends from the proximal end of the elongated member through the wall of the elongated member to the first fixing member, wherein the traction line is coupled to the first fixing member and wherein the elongated member is configured to deflect from an initial configuration to a deflection configuration in response to a traction force applied to the traction line. The outer circumferential member enables the hub assembly to be molded over at least a portion of the proximal portion of the elongated member, thereby isolating the traction line from the lumen of the conduit.

2. The catheter of claim 1, wherein the elongated member is further configured to deflect from the deflection configuration to the initial configuration in response to a thrust applied to the traction line.

3. The catheter of claim 1, wherein the traction line extends from the proximal end of the elongated member through at least a portion of the wall of the elongated member to the first fixation member.

4. The catheter according to claim 1, wherein the wall comprises: An elongated core layer defining an outer surface and an inner surface, the outer surface and the inner surface defining the longitudinally extending lumen; Inner layer, the inner layer being disposed on the inner surface of the elongated core layer; as well as Outer layer, the outer layer being disposed on the outer surface of the elongated core layer, The traction wire is configured in at least one of the following ways: between the inner layer and the core layer or through the inner layer.

5. The catheter of claim 4, wherein the elongated core layer comprises coiled or braided metal wire.

6. The catheter of claim 4, wherein the traction wire passes through the core layer and the outer layer and protrudes to the outer surface of the outer layer at the proximal portion of the elongated member.

7. The catheter of claim 1, wherein the first fixing member comprises at least one of a collar or a clamp, the collar or the clamp being configured to engage the outer surface of the wall of the elongated member by at least one of friction fit, compression fit or overmolding, and to connect to the distal end of the traction line.

8. The conduit of claim 1, wherein the distal end of the traction line comprises at least one of a spherical structure, a loop, a knot, a weld, or a washer.

9. The catheter of claim 1, wherein the distal end of the catheter includes a distal cup extending from the first fixation member to a distal tip of the distal cup, wherein the distal cup surrounds at least one of at least a portion of the first fixation member or at least a portion of the distal end of the traction line.

10. The catheter of claim 9, wherein the elongated member comprises a first polymer, wherein the distal cup-shaped member comprises a second polymer, and wherein at least one of the following conditions exists: the tensile strength of the second polymer is greater than the tensile strength of the first polymer, or the ductility of the first polymer is greater than the ductility of the second polymer.

11. The catheter of claim 1, wherein the second fixing component comprises: At least one of a collar or a chuck, said collar or chuck being configured to engage the outer surface of the wall of the elongated member by at least one of a friction fit or a compression fit; and A channel configured to hold the traction line in a sliding engagement.

12. The catheter of claim 11, wherein the second fixation member further comprises a retaining arm extending from the collar or the clamp, the retaining arm comprising a retaining channel extending from its distal end to its proximal end at an angle away from the longitudinal axis of the elongated member, wherein the retaining channel is configured to retain the traction line in a sliding engagement.

13. The catheter of claim 12, wherein the second fixation member further comprises an outer circumference coupled to the retaining arm, the outer circumference comprising an outer circumference channel configured to retain the traction line in a sliding engagement, wherein the outer circumference channel extends from its distal end to its proximal end at an angle away from the longitudinal axis of the elongated member.

Citation Information

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