Radial balloon catheter

Abstract

Disclosed herein is a catheter assembly and a method of administering the catheter assembly. In an example, the catheter assembly can include a catheter body and a frame member extending between a proximal end portion and a distal end portion, the frame member having a first mechanical property; and a floating sleeve coupled about the frame member and extending between the proximal end portion and the distal end portion, the floating sleeve having a second mechanical property different from the first mechanical property. The floating sleeve can include at least one floating section and one or more anchoring sections along the catheter body. The at least one floating section of the floating sleeve is movable relative to the frame member, and the one or more anchoring sections of the floating sleeve can be interconnected with the frame member.

Description

[0001] Priority application

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 012,664, filed April 20, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This document relates generally, but not restrictively, to catheters, or more specifically to balloon catheters. Background Technology

[0004] Catheters are used in a variety of medical procedures to perform therapeutic or diagnostic functions within a patient's body. For example, catheters are used to deliver medications, fluids, or gases to specific locations within a patient's body. In other examples, catheters are used in diagnostic procedures, to extract fluids for detection, or to drain fluids from a patient.

[0005] Balloon catheters are a variety of catheters. In some examples, a balloon catheter includes an elongated shaft with an inflatable balloon portion near the end of the shaft. In use, the catheter is inserted and advanced, for example using a guidewire, to position the balloon at the treatment site (e.g., a diseased blood vessel). Once inserted, the balloon inflates to widen the confinement, which can be a narrow opening or passage within the body. Summary of the Invention

[0006] The inventors have recognized that, among other things, the problem to be solved includes forming a long, soft conduit that is both flexible and maneuverable.

[0007] Catheters are used in some procedures within long and sometimes tortuous pathways, such as the radial or femoral arteries. Each of the radial or femoral arteries provides access to different locations within the body. For example, the radial artery extends from the wrist toward the eye. However, the length of the radial artery prevents the use of highly flexible catheters that lack good maneuverability, as it is difficult to maneuver a catheter across the length of the radial artery (e.g., 2.5 meters or more). Because the pathway is long, catheters of that length are long. Additionally, the radial artery has a smaller diameter than the femoral artery, and is therefore more difficult to navigate, especially with catheters containing lumens, therapeutic elements, etc. For convenient and accurate navigation and positioning of such catheters, the catheter body should be maneuverable to allow movement through the vessel and flexible to allow articulation through the vessel. In some examples, maneuverability and flexibility are inversely proportional. For example, a maneuverable catheter body may have reduced flexibility and impede articulation. Conversely, a flexible catheter body may have reduced maneuverability and impede movement through the vessel.

[0008] This topic provides a solution to these problems using a catheter body having a frame member positioned within a floating sleeve. The frame member comprises a material having a first mechanical property, such as a relatively high modulus of elasticity (a measure of stiffness), like a metal including stainless steel or the like. The floating sleeve is optionally constructed of a second material and the second material has a second mechanical property. For example, the floating sleeve has a relatively low modulus of elasticity compared to the frame member due to its second material property. As described herein, the frame member and the floating sleeve cooperatively provide axial stiffness along the length of the catheter body and simultaneously provide deflection for the articulation of the catheter body. Thus, the catheter body is easily moved (e.g., pushed) through the body while the catheter body is bent, curved, etc. (e.g., articulated).

[0009] In some examples, the frame member is a helical cut. Optionally, the helical cut of the frame member varies along the length of the frame member (including portions of the length). Variations in the helical cut along the length of the frame member include, but are not limited to, width, pitch, etc., and provide variations in mechanical properties such as elasticity. For example, the helical cut has a relatively large width and a shallow pitch (e.g., a flat or acute angle extending similarly to the longitudinal axis of the catheter body) at the proximal portion of the frame member. This arrangement provides enhanced stiffness and corresponding maneuverability at the proximal portion of the catheter body. Conversely, the helical cut at the distal portion of the frame member may optionally include (e.g., a relatively small width and a steeper pitch compared to the proximal portion) to enhance flexibility.

[0010] The frame member floats within an external floating sleeve. For example, the floating sleeve includes at least one floating section configured to be retractably hinged or laterally deflected relative to the frame member, causing the hinge portion of the catheter body to deflect. The floating sleeve may optionally include one or more anchoring sections that attach associated portions of the floating sleeve to corresponding portions of the frame member. In various examples, anchoring sections are positioned between floating sections, and one or more anchoring sections are located at one or both of the proximal or distal portions of the catheter body.

[0011] When in use, such as when applied within the body passage, the floating sleeve propels and supports the frame member during catheter body positioning. As the catheter body is hinged by deflection, bending, or other operator movement, the floating sleeve "floats," and at least a floating section of the floating sleeve translates relative to a previously corresponding section of the frame member. The floating sleeve and frame member move by one or more of a telescopic hinge (e.g., relative sliding movement) or lateral deflection to adjust the engagement between the floating sleeve and the frame member, and the corresponding degrees of freedom of movement between them. In this way, the floating section can telescopically or laterally deflect and move relative to the frame member. The freedom of movement and locally anchored sections provided by this arrangement support the deflection of the catheter and support the frame member, while simultaneously allowing deflection and minimizing stress rise compared to systems with other long joints (including one or more lengths of bonded interfaces, welds, shrink tubes, or the like) that may buckle, kink, etc., due to stress.

[0012] In one example, a gap is provided between the frame member and the floating sleeve. For example, the inner diameter of the floating sleeve is larger than the outer diameter of the frame member. When axially pushed, the frame member and the floating sleeve cooperate to provide axial stiffness, and the floating sleeve supports the frame member. During articulation of the catheter body, such as when navigating through bends and other tortuous features of a blood vessel, the gap facilitates one or more of the frame member's telescoping or lateral deflection relative to the floating sleeve. The components deflect differently with smaller stress rises between their interconnected parts (such as between the lining and sheath), which further restrict bending movement. For example, in one example, if the floating sleeve is anchored along the frame member, it can bend more freely than otherwise permitted. Continuous deflection provides a frictional engagement between the floating sleeve and the frame member that gradually increases (becomes longer and provides additional force). As deflection increases, the frictional engagement between the components provides a gradually increasing support force to the catheter body (e.g., correspondingly lengthening the frictional engagement and increasing friction). Therefore, even when the catheter body deflects, the frictionally engaged floating sleeve and frame members cooperate to support the catheter body and enhance maneuverability.

[0013] Therefore, the assembly of the floating sleeve and frame member provides one or more of a telescopic hinge or lateral deflection between the floating sleeve and the frame member to provide maneuverability to the conduit while maintaining supported deflection. In some examples, the frame member includes one or more features such as a spiral slit, helical cut, cut, slot, notch, etc., or the floating sleeve includes a floating section and an anchoring section, further enhancing the conduit's deflection while also ensuring its maneuverability. Examples of conduit assemblies with deflection and maneuverability via a floating component are described herein.

[0014] This disclosure is intended to provide an overview of the subject matter of this patent application. This disclosure is not intended to provide a non-exclusive or exhaustive interpretation of the invention. Detailed descriptions are included to provide further information regarding this patent application. Attached Figure Description

[0015] In drawings that are not necessarily drawn to scale, similar reference numerals may describe similar parts in different views. Similar reference numerals with different letter suffixes may indicate different instances of similar parts. The drawings generally illustrate the various embodiments discussed in this document by way of example rather than limitation.

[0016] Figure 1 This is an example view of the conduit component.

[0017] Figure 2 This is a view of an example frame member used for conduit components.

[0018] Figure 3A This is a schematic diagram of a conduit assembly with an anchoring section.

[0019] Figure 3B This is a schematic diagram of a deflection duct assembly with an anchoring section.

[0020] Figure 3C This is a schematic diagram of a deflection duct assembly with an anchoring section.

[0021] Figure 3D This is a schematic diagram of a deflection duct assembly with an anchoring section.

[0022] Figure 4A This is a schematic diagram of a conduit assembly with two anchoring sections.

[0023] Figure 4B This is a schematic diagram of a conduit assembly with two anchoring sections.

[0024] Figure 4C This is a schematic diagram of a deflection duct assembly with two anchoring sections.

[0025] Figure 4DThis is a schematic diagram of a deflection duct assembly with two anchoring sections.

[0026] Figure 5A This is a schematic diagram of a conduit assembly that moves within a telescopic hinge.

[0027] Figure 5B This is a schematic diagram of a deflection conduit assembly that moves within a telescopic hinge.

[0028] Figure 5C This is a schematic diagram of a deflection conduit assembly that moves within a telescopic hinge.

[0029] Figure 6 It is a block diagram depicting a method of using a conduit assembly. Detailed Implementation

[0030] The example catheter assemblies described herein are both maneuverable and flexible to enhance navigation along pathways including blood vessels and lumens. The devices and methods discussed herein include catheter assemblies that enhance maneuverability, resist compression-based failures such as buckling, and simultaneously provide varying stiffness (and corresponding deflection) during bending. The catheter assemblies described herein comprise two or more components, namely a floating sleeve and a frame component. In some examples, the two or more components have different mechanical properties. For example, the floating sleeve has different stiffness characteristics relative to the frame component. In one example, there is a gap or tolerance between the components to facilitate one or more of the lateral and axial movements between the components during deflection while maintaining a cooperative connection that supports the catheter assembly during maneuvering. During deflection, the deflecting portion engages one or more other movable surfaces within the floating section and supports the catheter assembly. During larger deflections, the larger deflecting portion enhances the engagement (e.g., an increase in engagement profile or an increase in friction) and correspondingly enhances the support for the catheter assembly. The relative movement and engagement of conduit assembly components, such as the floating sleeve and frame members, thus provide enhanced maneuverability through the support between the floating sleeve and the frame members, and at the same time provide enhanced support during deflection through the engagement of other relatively movable parts.

[0031] Figure 1 This is an example view of a catheter assembly 100 having a catheter body 101. The catheter body 101 of the catheter assembly 100 extends between a proximal portion 102 and a distal portion 104. Figure 1As shown, the example conduit assembly 100 includes a strain relief portion 106 and a hub 107. The conduit body 101 of the conduit assembly 100 extends distally from the hub 107 (e.g., through the strain relief portion 106) to a distal portion 104. As described herein, the conduit body 101 includes a floating sleeve 110 surrounding a frame member 130. As described in the examples herein, the floating sleeve 110 is engaged with the frame member 130 at one or more anchoring sections, while also including floating sections that allow relative movement between the floating sleeve 110 and the frame member 130.

[0032] exist Figure 1 In this assembly, the conduit assembly 100 includes a proximal anchorage section 108, an intermediate anchorage section 116, and a distal anchorage section 120. One or more floating sections, such as a proximal floating sleeve section 112, are positioned between the anchorage sections. For example, the proximal floating sleeve section 112 is positioned between the proximal anchorage section 108 and the intermediate anchorage section 116.

[0033] In another example, instead of the intermediate anchorage section 116, Figure 1 The catheter body includes a connecting portion 114 that connects the distal floating sleeve section 118 and the proximal floating sleeve section 112 to each other. The distal floating sleeve section and the proximal floating sleeve section 112 are positioned between the distal anchoring section 120 and the proximal anchoring section 108.

[0034] Now refer to Figure 2 The frame member 130 of the catheter assembly 100 extends between a proximal portion 132 and a distal portion 134. In one example, the distal portion 134 of the frame member 130 includes an end portion 144 having a cut 146 (e.g., a tapered edge for easier insertion and guidance of the guide tube). The frame member 130 in this example includes one or more helical grooves 137 (e.g., cuts, notches, perforations, or the like). For example, the helical groove includes one or more pitch angles 136, 138, pitch widths 140, 142, or the like to provide specific mechanical properties to the various portions of the frame member 130 and corresponding properties to the catheter assembly 100. (See again...) Figure 1 The catheter assembly 100 optionally includes an inlet port 122 for rapid exchange delivery of the catheter assembly 100. Figure 1 In the example shown, the catheter body includes a balloon 124, a balloon protector 126, and a distal tip assembly 128, such as an atraumatic tip. The catheter assembly 100 extends between a proximal portion 102 and a distal portion 104 and has a strain release portion 106 near the proximal portion 102 and a hub 107 (e.g., a Luerfitting or the like).

[0035] exist Figure 1 In the example shown, a floating sleeve 110 receives a frame member 130 therein. The floating sleeve 110 includes a proximal floating sleeve section 112 and a distal floating sleeve section 118 connected by a floating sleeve connection 114 (e.g., an anchoring section 116 in another example). The floating sleeve may optionally include a floating section (disconnected from the frame member 130) extending from the proximal portion 102 to the distal portion 104. In another example including anchoring sections 108, 116, and 120, the floating sleeve 110 includes a floating section 112 located between anchoring sections 108 and 116 and a floating section 118 located between anchoring sections 116 and 118. As described herein, anchoring sections 108, 116, and 120 secure the floating sleeve 110 to the frame member 130, while the remainder of the floating sleeve 110 is disconnected from the frame member 130. In the example that includes an inlet port, port 122 is located near the remote portion 104, such as near the remote anchoring section 120.

[0036] In one example, the length of the catheter body 101 of assembly 100 is between about 2.0 m and about 4.0 m. As described herein, the catheter body 101 is a component of catheter assembly 100, which has a hub 107 and one or more instruments, catheter instruments, guiding catheters, introducers, or the like for delivery through a patient's blood vessels and lumens, such as from the leg to the heart or from the wrist to the heart. As described herein, catheter assembly 100 and variations thereof are dextral and flexible.

[0037] For example, catheter assembly 100 may be a catheter for draining, dispensing fluid or gas, for insertion by surgical instruments, or for performing various other procedures according to the intended outcome. A strain relief portion 106 is located on or near the proximal portion 102 (e.g., near the hub 107) to provide mechanical stress relief for assembly 100.

[0038] The catheter assembly 100 may optionally include a biocompatible coating thereon, such as a hydrophilic coating on the outer surface of the catheter body 101 or the floating sleeve 110 to facilitate insertion. For example, the coating may be a drug-eluting coating or a hydrophilic lubricating coating, such as those described in US 9,86,1727, US 9,372,217 and US 2014 / 0193474, which are incorporated herein by reference.

[0039] The floating sleeve 110 and the outer body are outer sheath-like structures in the conduit assembly 100 that are connected (e.g., cover, partially cover, surround, or partially surround) around the frame member 130. The floating sleeve 110 does not need to be attached to the frame member 130. In this example, a gap exists between the floating sleeve 110 and the frame member 130 to allow relative movement between them. The floating sleeve 110 has one or more mechanical properties, including but not limited to elastic modulus, yield strength, tensile strength, hardness, Young's modulus, etc., which differ from corresponding properties of the frame member 130. In other examples, the mechanical properties of the floating sleeve 110 and the frame member 130 are matched (e.g., similar, close to each other, identical, etc.).

[0040] The floating sleeve 110 may optionally include multiple floating sections alternating with the anchoring sections. For example, in Figure 1 The diagram shows two floating sections, namely a near-end floating sleeve section 112 and a far-end floating sleeve section 118, which are arranged alternately with three anchoring sections: a near-end anchoring section 108, an intermediate anchoring section 116, and a far-end anchoring section 120. The floating sleeve 110 and the anchoring sections are interconnected with the frame member 130 to allow one or more floating sections of the sleeve 110 to move relative to the frame member 130 (e.g., lateral movement, telescopic hinges, etc.).

[0041] In one example, the proximal floating sleeve section 112 has greater mechanical properties, such as a higher elastic modulus, compared to the distal floating sleeve section 118, and the proximal floating sleeve section 112 extends along the proximal portion 102 of the conduit assembly 100. The proximal floating sleeve section 112 is made, for example, of polyamide 11 or other bioplastics. A floating sleeve connection 114 located on or near an intermediate anchoring section serves as a joint between the proximal floating sleeve section 112 and the distal floating sleeve section 118. As described herein, in another example, the floating sleeve connection 114 includes a central or intermediate anchoring section 116 that anchors both the proximal floating sleeve section 112 and the distal floating sleeve section 118 to the frame member 130.

[0042] In another example, the distal floating sleeve section 118 has lower mechanical properties, such as a lower elastic modulus, compared to the proximal floating sleeve section 112. Therefore, the distal floating sleeve section 118 is more flexible than the proximal floating sleeve section 112. The distal floating sleeve section 118 may optionally be made of an elastic material, such as a polyamide 12 elastomer.

[0043] One or more anchoring sections are positioned within the conduit assembly 100 to allow the floating sleeve 110 to be attached at designated locations along the conduit assembly 100. One or more anchoring sections secure, fix, or anchor the floating sleeve 110 to corresponding portions (multiple portions) of the frame member 130. Figure 1 In this configuration, the proximal anchorage section 108 is optionally positioned below the strain relief portion 106 between, for example, the floating sleeve 110 and the frame member 130. The anchorage section secures the proximal portions of the sleeve 110 and the frame member 130 at least to prevent relative longitudinal movement in at least one direction (e.g., proximal, distal, or both). For example, each anchorage section of the conduit assembly 100 restricts longitudinal movement near the anchorage section in at least one degree of freedom between the floating sleeve 110 and the frame member 130 (e.g., allowing unidirectional longitudinal movement while simultaneously restricting longitudinal movement in the opposite direction, or restricting longitudinal movement in multiple directions).

[0044] Example intermediate anchorage section 116 is located between proximal floating sleeve section 112 and distal floating sleeve section 118, for example, near floating sleeve connection 114. In the example including intermediate anchorage section 116, this section secures the proximal portion of frame member 130 and the proximal portion of floating sleeve 110. For example, intermediate anchorage section 116 inhibits relative movement (including longitudinal movement, rotational movement, etc.) between the proximal portion of frame member 130 and the proximal portion of floating sleeve 110 in one or more directions.

[0045] The distal anchorage section 120 is located on or near the distal portion 104 of the conduit assembly 100 between the floating sleeve 110 and the frame member 130. Figure 1 In the example shown, the distal anchoring section 120 is located near the entry port 122, such as a quick-change entry port. In some cases, the distal anchoring section 120 secures (e.g., fixes, anchors, etc.) the proximal portion of the frame member 130 to the corresponding portion of the floating sleeve 110. Optionally, the distal anchoring section 120 is integral with the entry port 122. In one example, the distal anchoring section 120 constrains the relative movement between the floating sleeve 110 and the associated portion of the frame member 130 in one or more degrees of freedom. For example, the distal anchoring section 120 constrains the relative distal movement of the distal portion of the frame member 130 relative to the associated distal portion of the floating sleeve 110. In another example, the distal anchoring section 120 allows proximal relative movement of the distal portion of the frame member 130 relative to the distal portion of the floating sleeve 110.

[0046] Despite Figure 1Three anchoring sections are shown, but in other examples, one or more anchoring sections are used. For example, two anchoring sections and one or more associated floating sections for the floating sleeve 110 are positioned at different locations along the catheter body 101. In another example, one anchoring section is provided along the catheter body 101 and the remainder of the floating sleeve 110 includes one or more floating sections. Anchoring sections, floating sections, etc., are used individually, in combination, collaboratively, etc., in various examples to provide specific mechanical properties to the catheter assembly 100. As described herein, additional anchoring sections and associated floating sections provide enhanced support (e.g., bearing) for the catheter body 101 with initial deflection and larger deflection. In contrast, fewer anchoring sections and associated floating sections provide moderate support for the catheter body 101 with initial deflection and larger deflection. As described herein, the increased deflection of the conduit body 101 (in each of the configurations discussed above and herein) adjusts the support provided between the floating sleeve 110 and the frame member 130.

[0047] As described herein, relative movement is permitted and guided by the floating section of the floating sleeve 110. For example, relative movement between the frame member 130 and the floating sleeve 110 occurs in the anchored section, such as... Figure 1As shown in the example, this occurs along the floating sleeve segment between the proximal anchoring segment 108 and the intermediate anchoring segment 116. During actuation, such as when the catheter assembly 110 moves distally within the vessel, the floating sleeve 110 and the frame member 130 support each other because the floating sleeve 110 extends around the frame member 130 and the frame member 130 extends through the floating sleeve 110. The components cooperate to enhance the strength of the catheter body 101 and thereby resist buckling. Additionally, upon deflection, the frame member 130 and the floating sleeve 110 progress from an unbonded configuration to one or more bonded configurations. In the unbonded configuration, the floating segment of the floating sleeve 110 is allowed to move relative to the associated portion of the frame member 130 to reduce deflection constraints caused by welded components (e.g., bonded liner and sleeve, shrink sleeve on the liner, or the like). For example, the frame member 130 and the floating sleeve 110 do not resist movement against each other. With increased deflection, the floating section and frame member 130 engage and bind to each other (e.g., frictionally) during deflection to support and hold the catheter body 101 of assembly 100. As described herein, with additional deflection, the engagement and binding between the floating section of the floating sleeve 100 and the frame member 130 increases, and the support for the catheter body 101 is thus enhanced in a progressive manner corresponding to the degree of deflection. In this case, the two parts can be allowed to bend or deflect when resisting each other. As described herein, the engagement and binding between one or more floating sections of the floating sleeve 110 and the frame member 130 is initiated and progressively binds with the deflection of the catheter body 101. The relative movement between the frame member 130 and the floating sleeve 110 (e.g., near the floating section) – which is part of the deflection of the conduit body 101 and includes, but is not limited to, sliding, pushing, deflecting, and telescopic movements – initiates and enhances the frictional engagement between the components (110 and 130), and the frictional engagement (including static engagement and constrained relative movement) gradually increases with deflection.

[0048] As described herein, anchoring the frame member 130 and the floating sleeve 110 at one or more anchoring sections provides additional resistance to relative movement, at least until the frictional engagement with sufficient deflection restricts all relative movement. For example, in the catheter assembly discussed herein, the proximal anchoring section 108 and the intermediate anchoring section 116 provide greater stiffness at the proximal portion 102 of the catheter assembly 100 compared to the stiffness provided at the distal portion of the catheter assembly 100. Alternatively, the distal anchoring section 120 allows a limited degree of relative movement relative to the proximal portion 102 (e.g., proximal movement of the frame member 130 relative to the sleeve 110), and thus provides less (initial) stiffness to the distal portion of the catheter assembly 100. Reference will be made below. Figures 3A to 5BThe deflection of the conduit assembly 101 and the relative motion between the floating sleeve 110 and the frame member 130 are discussed in more detail.

[0049] Figure 1 The access port 122 shown is a quick-change port to facilitate easy access to the frame member 130 when applying or inserting the catheter assembly 100 into a patient cavity or access route. Access port 122 allows for easy removal of the frame member 130 or other reinforcing wires. Figure 1 As shown, the frame member 130 terminates in or near the access port 122 such that the frame member 130 does not reach or interact with the balloon 124 or balloon protector 126. In some cases, an additional guidewire may be used in conjunction with the access port 122 to facilitate movement of the catheter assembly 100.

[0050] Balloon 124 is shielded by balloon protector 126 to prevent balloon 124 from being punctured before or during insertion. Balloon 124 and balloon protector 126 are coupled to the distal floating sleeve section 118 in or near the distal portion 104 of the catheter assembly 100. Subassembly 128 includes supports for balloon 124 and balloon protector 126 and serves as an insertion tip for the catheter assembly 100. Balloon protector 126 can be removed after or during insertion.

[0051] exist Figure 2 It is shown in more detail in the middle. Figure 1 The conduit assembly 100 includes a frame member 130 having a proximal portion 132 and a distal portion 134. The frame member 130 may be, for example, a thiourea tube, reinforcing filament, braid, coil, internal polymer lining, etc., that enhances maneuverability and resistance to buckling. The frame member 130 has mechanical properties that enhance the strength of the conduit assembly 100, such as elastic modulus, yield strength, tensile strength, flexural modulus, stiffness, Young's modulus, etc. In one example, the frame member 130 has greater strength (e.g., tensile strength, etc.) than the floating sleeve 110, which is less rigid (e.g., more elastic, more flexible, etc.).

[0052] A frame member 130 extends between the proximal portion 102 and the distal portion 104 of the catheter body 101 of the catheter assembly 100. The frame member 130 is at least partially received within a floating sleeve 110, wherein there is an optional gap between the frame member 130 and the floating sleeve 110. As described herein, the frame member 130 and the floating sleeve 110 are not coupled along a continuous length of the frame member 130, such that the frame member 130 and the floating sleeve 110 can “float” or move relative to each other (e.g., along one or more floating sections). In some cases, the frame member 130 is coupled discontinuously to the floating sleeve 110 at different locations, such as one or more anchoring sections. The floating configuration of the frame member 130 and the floating sleeve 110 facilitates and controls variations in the mechanical properties of the entire catheter assembly 100, such as variations in flexibility and maneuverability.

[0053] In one example, a physical gap exists between the frame member 130 and the floating sleeve 110, facilitating lateral and longitudinal movement between them. This gap allows for sliding, movement, extension, and other movements between the frame member 130 and the floating sleeve 110. For example, a slit may be provided between the frame member 130 and the floating sleeve 110, representing a change in the sleeve's inner diameter (larger) compared to the frame member's outer diameter (smaller). In other examples, the frame member 130 and the floating sleeve 110 are movably connected without a defined gap. Alternatively, the components may be allowed to move relative to each other (e.g., slide, deflect, etc.) depending on the flexibility of one or more components, negligible tolerances (which ensure a close fit while allowing sliding movement), etc. Reference will be made below. Figures 3A to 5C The motion between frame member 130 and floating sleeve 110 is discussed in more detail.

[0054] like Figure 2 As shown, frame member 130 has a helical cut 137 (e.g., having a spiral, inclined, or helical configuration, a full-penetration cut, a perforation, etc.) along its length from distal portion 134 to proximal portion 132. This enhances flexibility near proximal portion 132 while maintaining a specific rigidity and maneuverability near distal portion 134. In one example, the helical cut 137 is continuous along the length of frame member 130.

[0055] In another example, the configuration of the helical cut varies (or is absent) along frame member 130 to alter the mechanical properties of the frame member. For example, as... Figure 2 As shown, the pitch angle gradually changes along the length of frame member 130. Figure 2As shown, the pitch angle, such as angle 136, can be measured between the helical cut portion and the bottom of the frame member 130. Similarly, the pitch width, such as pitch width 142, can be measured laterally between the two helical cut portions.

[0056] In this example, the pitch angle gradually increases (becomes steeper) from the proximal portion 132 to the distal portion 134. For example, in Figure 2 In this configuration, the first pitch angle 136 is shallower relative to the horizontal position compared to the second pitch angle 138. Therefore, the proximal portion with the shallower pitch angle 136 has enhanced strength and corresponding maneuverability, while the distal portion with the relatively steeper second pitch angle 138 has enhanced flexibility to facilitate bending.

[0057] Similarly, the pitch width gradually increases along the length of the frame member 130 from the distal portion 134 to the proximal portion 132. For example, in Figure 2 In this configuration, the second pitch width 140 is greater than the first pitch width 142. The varying pitch angle and pitch width allow for increased flexibility on or near the distal portion 134 of the frame member 130, but increased rigidity and maneuverability on or near the proximal portion 132 of the frame member 130. Figure 2 In the example shown, a steeper pitch angle and a smaller pitch width can increase flexibility. Conversely, a shallower pitch angle and a larger pitch width can increase strength and maneuverability.

[0058] End portions 144 and cut portions 146 are located on or near the distal portion 134 of the frame member 130. When the frame member 130 is located within the floating sleeve 110, the end portion 144 rests on or near the inlet port 122. In some examples, the profile of the end portion 144 provides a stress riser during deflection of the conduit body 101. In one example, to prevent kinking near the end portion 144, the distal anchoring section 120 (see...) Figure 1 It can be located near the inlet port 122 and near the end portion 144 of the frame member 130. The distal anchoring section 120 reinforces this location in the conduit assembly 100 while reducing stress rise (while releasing other parts for floating).

[0059] Catheter assembly 100 - in Figure 1 and Figure 2The image depicts a catheter assembly 100, which includes a floating configuration of the sleeve and frame members—allowing forces applied at the proximal portion 102 to be transmitted to the distal portion 104 while reducing buckling, kinking, or similar conditions. Additionally, the catheter assembly 100 provides enhanced deflection and support to the catheter body 101 as it deflects with the floating and anchoring sections of the floating sleeve 110 and the frame member 130. In one example, this is achieved by using a radial clearance between the frame member 130 and the floating sleeve 110 to, for example, cause the parts to act under compression and individually during bending to a point where extreme bending causes both the frame member and the floating sleeve 110 to act together. In other examples, lateral relative movement and telescopic movement may be permitted based on the clearance.

[0060] Therefore, the catheter assembly 100 has two or more stiffness profiles during bending. For example, with the floating sleeve 110 and frame member 130 cooperatively coupled to allow relative movement, an increased (support) stiffness profile and a decreased (deflection-enhancing) stiffness profile are provided. As described herein, the decreased (deflection-enhancing) stiffness profile is an optional initial condition. For example, as the catheter assembly navigates through a blood vessel, the floating section of sleeve 110 is movable relative to frame member 130, thereby allowing the catheter assembly 100 to easily deflect (e.g., bend, kink, etc.) as it passes through the blood vessel. As the catheter assembly passes through the blood vessel and deflects to follow the contours of the vessel, the floating section moves laterally (e.g., in the case of an intermediate gap), longitudinally (e.g., in the case of a gap or sliding engagement), or similarly. The relative movement between the frame member 130 and the floating sleeve 110 allows these components (at least along the floating section) to act independently, minimizing the joint between the frame member 130 and the floating sleeve 110 and the corresponding stress rise (which may cause resistance to travel through the vascular geometry, such as flexion or kinking), and allowing deflection of the catheter body 101.

[0061] In contrast, with an increased (support) stiffness profile, such as under deflection conditions greater than the initial (no deflection or low deflection) conditions, the catheter assembly 100 resists stress-induced failure events, such as kinking or buckling that might occur in any section when the catheter assembly 100 is unsupported. For example, as the catheter body 101 is navigated through a relatively tortuous geometry, the catheter body 101 experiences greater deflection and corresponding increased stress. As previously mentioned, the floating sleeve 110 with the floating sleeve section and the frame member 130 are generally allowed to move relative to each other. In the case of increased deflection (e.g., bending or flexing), these components engage (as shown in subsequent figures). This engagement, for example, utilizes the friction generated by the engagement to support one component to the other. Additionally, the degree of deflection thus alters the engagement interface between the frame member 130 and the floating sleeve section (the engagement interface increases with greater deflection), thereby also increasing the friction and support provided to the components. Frictional engagement (and engagement that increases with deflection) provides increasing support between the floating sleeve 110 and the frame member 130, and these components function as a member to resist bending stresses applied to the conduit assembly 100.

[0062] This type of sport in Figures 3A to 3D as well as Figures 4A to 4D As shown in the figure, and will be referenced Figures 3A to 3D as well as Figures 4A to 4D This needs to be discussed. Figures 3A to 3D This is a schematic diagram of a conduit assembly 300 having an anchoring section 308. Figures 4A to 4B This is a schematic diagram of a conduit assembly 400 having two anchorage sections 408 and 420. Conduit assembly 300 includes a proximal portion 302, a distal portion 304, a proximal anchorage section 308, a floating sleeve 310, and a frame member 330. Conduit assembly 400 includes a proximal portion 402, a distal portion 404, a proximal anchorage section 408, a floating sleeve 410, a distal anchorage section 420, and a frame member 430. Unless otherwise stated, assemblies 300 and 400 include components similar to those referenced above. Figure 1 and Figure 2 The components discussed are similar to those in the discussion.

[0063] exist Figure 3A and Figure 4A In the process, the catheter assemblies 300A and 400A are in the initial stiffness profile during initial application or when applied by minimizing the tortuous path, for example, when they are at rest.

[0064] exist Figure 3B and Figure 4BIn this context, the conduit assemblies 300B and 400B are in a first deflection stiffness profile, for example, during application through a significantly tortuous path. The frictional engagement between the floating sleeves (310, 410) and the corresponding frame members (330, 430) can be considered as segments 305 and 405.

[0065] exist Figure 3C and Figure 4C In the process, the catheter assemblies 300C and 400C are in a second deflection stiffness profile, for example, during application through a significantly tortuous path, which is more than... Figure 3B and Figure 4B The deflection stiffness profile is further deflected. The friction joint between the floating sleeves (310, 410) and the corresponding frame members (330, 430) can be considered as segments 305 and 405. The friction joint area here is... Figure 3B , Figure 4B The difference will be larger in the middle, due to a deeper degree of deflection.

[0066] exist Figure 3B and Figure 4B In the process, conduit assemblies 300B and 400B are in a first deflection stiffness profile, for example, during application through a significantly tortuous path, which is more than... Figure 3C and Figure 4C The deflection stiffness profile is further deflected. The friction joint between the floating sleeves (310, 410) and the corresponding frame members (330, 430) can be considered as segments 305 and 405. Here, this friction joint area is... Figure 3C , Figure 4C The difference will be larger in the middle, due to a deeper degree of deflection.

[0067] The gap between the floating sleeve and the frame member allows relative movement between them during deflection. This assembly acts like a bow or rod within a larger tube, engaging with it during a deflection sufficient to cause engagement. The gap provides a slit between the frame member and the floating sleeve, which is definitively bridged during deflection of the device. In contrast, more readily occurring bridging occurs in the initial, non-deflecting configuration.

[0068] Various types of stress, such as buckling, compression, and bending, are applied to the conduit assembly during application. The conduit assembly discussed in this paper can resist many of these stresses due to the interaction between the frame members and the floating sleeve.

[0069] The frame members work in conjunction with floating sleeves to resist buckling. The resistance to buckling is mathematically defined as follows:

[0070]

[0071] Among them, P er Let E be the critical longitudinal load (Euler), E be the elastic modulus, I be the moment of inertia of the section, K be the effective length factor, and L be the unsupported length of the column.

[0072] For the catheter assembly discussed herein, the frame member and the floating sleeve are assembled such that the frame member and the floating sleeve are secured together at at least one end (e.g., Figures 3A to 3B Or they can be fixed together at more ends (e.g.) Figures 4A to 4B Therefore, there will be no relative longitudinal movement between these two parts, and thus the resistance to buckling is described as:

[0073]

[0074] Where E1 is the elastic modulus of the frame member, I1 is the moment of inertia of the frame member, E2 is the elastic modulus of the floating sleeve, and I2 is the moment of inertia of the floating sleeve.

[0075] Similarly, the frame members and floating sleeves work together under compressive stress. Compression is mathematically described as:

[0076]

[0077] Where, δ c Let A1 be the cross-sectional area of ​​the frame member and A2 be the cross-sectional area of ​​the floating sleeve, where A1 is the compressive stress. Resistance to buckling and compressive stresses can be increased by increasing the outer diameter of the conduit assembly, which will increase the moment of inertia (I) and cross-sectional area (A) terms in the above equations.

[0078] The conduit assembly also resists bending. Bending stress is described as follows:

[0079]

[0080] Where, δ m Let M be the bending stress, y be the bending moment, y be the distance to the centroidal axis, and I be the moment of inertia of the cross section about the z-axis.

[0081] The resistance of a conduit assembly to bending stress, such as device deflection, is relative to the moment of inertia I of the cross section, which alternates between smaller and larger bends during device bending. Under larger bending conditions, such as... Figure 3B , Figure 4B As shown, the frame member and the floating sleeve are in contact with each other, and the moment of inertia of the assembly is calculated using the combined radius value. This occurs due to the frictional contact between the outer diameter (r1) of the frame member and the inner diameter (r2) of the floating sleeve, which restricts or stops the relative longitudinal movement between the two members. The moment of inertia (I) of the section about the ring is described as follows:

[0082]

[0083] Where r1 and r2 are the inner and outer radii of the ring. The greater the difference between the radii, the greater the value of the moment of inertia of the section.

[0084] When the frame member is in contact with the floating sleeve and its relative longitudinal movement is restricted (e.g., due to engagement, friction, etc.), r2 becomes the outer diameter of the floating sleeve and r1 becomes the inner diameter of the frame member. Under greater bending conditions, the moment of inertia (I) of the section is larger, thus ensuring that the assembly has greater resistance to bending stress, i.e., greater resistance to kinking.

[0085] Under minor bending conditions, the frame members and the floating sleeve move independently relative to each other as the device bends. Therefore, the moments of inertia of the frame members and the floating sleeve cannot act in combination. When the assembly is under bending stress, but not a large bending stress, the bending stress in the assembly occurs at the outer diameter of the floating sleeve because the distance to the centroidal axis is increased. Additionally, the moment of inertia (I) of the frame members acts independently without the need for external support. The minor bending stress occurs at the outer diameter of the frame members because the distance to the centroidal axis is smaller compared to the distance to the floating sleeve. The moment of inertia (I) of the floating sleeve acts independently of the frame members.

[0086] The deflection profile (e.g., deflection range) of the conduit assembly is based on both small and large bending conditions. When bending stress is applied to the conduit assembly, contact begins between the frame member and the floating sleeve. As the bending stress increases, the surface contact area and the force acting on that surface area also increase. The frictional force also increases with the increase in surface contact and force between the frame member and the floating sleeve. Based on this, the stiffness of the conduit assembly increases with increasing bending stress. This provides a smooth transition from non-rigid to rigid conditions in terms of the bending stress applied to the conduit assembly during use.

[0087] Figures 3A to 3D A conduit assembly 300 with an anchoring section 308 is depicted, while Figures 4A to 4D A conduit assembly 400 with two anchorage sections 408 and 420 is depicted. The additional anchorage sections provide greater stiffness from the outset, which minimizes the need for friction to provide engagement between the floating sleeve and the frame members during deflection. Conversely, fewer anchorage sections favor deflection and rely on frictional engagement under greater deflection of the conduit assembly. The number and location of the anchorage sections can be selected and adjusted to achieve specific characteristics that increase and decrease with deflection.

[0088] As the conduit assembly deflects more, the contact points between the frame members and the floating sleeve increase because each has a larger contact area with the other. With increased deflection, the contact points lengthen due to the increased length and normal force caused by the deflection, thus providing additional friction to support one component against the other.

[0089] Figures 5A to 5C This is a schematic diagram of a conduit assembly 500 that can move with a telescopic hinge, such as sliding with no tolerance or minimal tolerance. The conduit assembly 500 includes a proximal portion 502, a distal portion 504, an anchor point 508, a floating sleeve 510, and a frame member 530. Two indexed positions 532 and 534 are shown in the conduit assembly 500 to illustrate the telescopic movement of the frame member 510 within the floating sleeve 530.

[0090] Frame member 530 and floating sleeve 510 are in the following position Figure 5A The initial non-deflection conditions shown interact with each other in a smaller way, while under conditions such as Figure 5B and Figure 5C The deflection conditions shown interact with each other in a significant manner. This can be achieved via sliding members, where the increased friction during deflection causes the two members to complement each other's resistance to bending. The floating sleeve is capable of hinged to the frame member 530 during the application of the conduit assembly 500.

[0091] In assembly 500, upon deflection of the conduit assembly, frame member 530 and floating sleeve 510 engage immediately or almost immediately at the friction engagement section 505. Frame member 530 and floating sleeve 510 may initially slide on each other with increased deflection, but deflection initiates engagement between the surfaces of frame member 530 and floating sleeve 510 and immediately applies friction between them. Friction increases with deflection (e.g., when one or more of the normal force and the dimensions of the engagement surfaces increase). Figure 5A and Figure 5B In contrast, the frictional engagement 505 between the floating sleeve 510 and the frame member can increase (e.g., become longer) with increasing deflection, such as... Figure 5C As shown in the diagram, the catheter assembly 500 has different deflection and strength profiles along its length. For example, the deflection is initially high due to the minimal frictional engagement. The deflection tends to decrease as deflection occurs. Conversely, the mechanical strength increases due to the frictional engagement 505 during deflection (and the frictional engagement increases with greater deflection), to support the catheter assembly 500 and thereby minimize complexities such as kinks.

[0092] In some cases, component 500 may additionally include one or more anchoring sections. For example, frame member 530 may be anchored at one end, such as in proximal portion 502, while the remainder of the interface between frame member 530 and floating sleeve 510 is slidably coupled. In this case, the conduit assembly may be slidably engaged between frame member 530 and floating sleeve 510.

[0093] Anchoring the frame member 530 and the floating sleeve 510 at certain points, and utilizing the friction between the frame member 530 and the floating sleeve 510, are complementary methods for achieving stiffness profiles across the device. Both methods restrict the relative movement between the frame member 530 and the floating sleeve 510, and this restricted relative movement can alter the overall stiffness of the two combined components.

[0094] Figure 6 This is a schematic diagram depicting an example method 600 for applying a catheter assembly. The method includes steps 610 through 620. In step 610, the catheter assembly is inserted into a pathway, such as within a patient's body. The catheter assembly includes a frame member and a floating sleeve coupled around the frame member. The frame member and the floating sleeve have different mechanical properties.

[0095] In step 620, the catheter assembly is pushed and guided toward a target location within the pathway. The pushing and guiding catheter assembly includes a floating sleeve that is telescopically hinged relative to a frame member.

[0096] In some cases, the floating sleeve includes one or more floating sleeve sections arranged alternately with one or more anchoring sections. In this case, the actuation conduit includes telescopically hinged one or more floating sections relative to the frame members.

[0097] Various annotations and various aspects

[0098] Aspect 1 may include a catheter assembly, which may include, for example, a catheter body extending between a proximal and a distal portion. The catheter body includes: a frame member extending between the proximal and distal portions, the frame member having a first mechanical characteristic; and a floating sleeve connected around the frame member and extending between the proximal and distal portions, the floating sleeve having a second mechanical characteristic different from the first mechanical characteristic. The floating sleeve includes at least one floating section and one or more anchoring sections along the catheter body. At least one floating section of the floating sleeve is movable relative to the frame member, and one or more anchoring sections of the floating sleeve are interconnected with the frame member.

[0099] Aspect 2 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly, wherein the conduit body includes an initial configuration and a deflection configuration: in the initial configuration, in the deflection configuration, the conduit body is deflected relative to the initial configuration, and at least a portion of the floating section is frictionally engaged with the frame member according to the degree of deflection.

[0100] Aspect 3 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly, wherein at least one floating section of the floating sleeve is capable of being articulated in a retractable manner.

[0101] Aspect 4 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly, wherein the first mechanical property or the second mechanical property includes at least one of yield strength, tensile strength, hardness, and Young's modulus.

[0102] Aspect 5 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly having a gap between the floating sleeve and the frame member.

[0103] Aspect 6 may include the subject of aspect 1 or may optionally be combined with the subject of aspect 1 to optionally include a conduit assembly, wherein the frame member is slidable within a floating sleeve.

[0104] Aspect 7 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly, wherein the frame member includes a submersible tube.

[0105] Aspect 8 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly, wherein the frame member includes reinforcing wires.

[0106] Aspect 9 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly, wherein the frame member includes a braid or a coil.

[0107] Aspect 10 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly, wherein the frame member includes an internal polymer liner.

[0108] Aspect 11 may include the subject of aspect 1 or may optionally be combined with the subject of aspect 1 to optionally include a conduit assembly, wherein the frame member is configured to allow the conduit assembly to be pushed.

[0109] Aspect 12 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a catheter assembly, wherein the floating sleeve includes a distal floating sleeve section and a proximal floating sleeve section.

[0110] Aspect 13 may include the subject matter of aspect 12 or may optionally be combined with the subject matter of aspect 12 to optionally include a conduit assembly, wherein the distal floating sleeve section has less rigidity than the proximal floating sleeve section.

[0111] Aspect 14 may include the subject matter of aspect 12 or may optionally be combined with the subject matter of aspect 12 to optionally include a catheter assembly, wherein the floating sleeve further includes a connecting portion connecting the distal floating sleeve section to the proximal floating sleeve section.

[0112] Aspect 15 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a conduit assembly, wherein the frame member includes a helical cut portion.

[0113] Aspect 16 may include the subject matter of aspect 15 or may optionally be combined with the subject matter of aspect 15 to optionally include a conduit assembly, wherein the helical cut portion includes a continuous cut portion around the outer surface of the frame member.

[0114] Aspect 17 may include the subject matter of aspect 15 or may optionally be combined with the subject matter of aspect 15 to optionally include a conduit assembly, wherein the helical cut portion has a first pitch angle and a second pitch angle, the second pitch angle being smaller than the first pitch angle.

[0115] Aspect 18 may include the subject matter of aspect 17 or may optionally be combined with the subject matter of aspect 17 to optionally include a conduit assembly, wherein the helical cut portion gradually changes from a first pitch angle to a second pitch angle along the frame member from the distal portion of the assembly to the proximal portion of the assembly.

[0116] Aspect 19 may include the subject matter of aspect 15 or may optionally be combined with the subject matter of aspect 15 to optionally include a conduit assembly, wherein the helical cut portion has a first pitch width and a second width angle, the second width angle being greater than the first pitch width.

[0117] Aspect 20 may include the subject matter of aspect 19 or may optionally be combined with the subject matter of aspect 19 to optionally include a conduit assembly, wherein the helical cut portion gradually changes from a first pitch width to a second pitch width along the frame member from the distal portion of the assembly to the proximal portion of the assembly.

[0118] Aspect 21 may include the subject matter of aspect 19 or may optionally be combined with the subject matter of aspect 19 to optionally include a conduit assembly, wherein one or more anchoring sections include a first anchoring section located near the proximal portion of the assembly, a second anchoring section located between the proximal portion of the assembly and the distal portion of the assembly, and a third anchoring section located near the distal end of the assembly.

[0119] Aspect 22 may include the subject matter of aspect 21 or may optionally be combined with the subject matter of aspect 21 to optionally include a conduit assembly, wherein the first anchoring section, the second anchoring section and the third anchoring section allow the frame member to move within the floating sleeve between the first anchoring section, the second anchoring section and the third anchoring section.

[0120] Aspect 23 may include the subject of aspect 1 or may optionally be combined with the subject of aspect 1 to optionally include a conduit assembly, which also includes a fast-switching port located on the distal portion of the assembly.

[0121] Aspect 24 may include the subject of aspect 1 or may optionally be combined with the subject of aspect 1 to optionally include a conduit assembly, wherein the length of the assembly is from about 2.0 m to about 4.0 m.

[0122] Aspect 25 may include the subject of aspect 1 or may optionally be combined with the subject of aspect 1 to optionally include a conduit assembly, wherein the length of the assembly is from about 2.5m to about 3.5m.

[0123] Aspect 26 may include the subject matter of aspect 1 or may optionally be combined with the subject matter of aspect 1 to optionally include a catheter assembly, the catheter assembly further including a guidewire for applying the catheter assembly.

[0124] Aspect 27 may include a catheter assembly, such as a catheter body extending between a proximal and a distal portion. The catheter body may include: a frame member extending between the proximal and distal portions, the frame member having a first mechanical property; and a floating sleeve connected around the frame member and extending between the proximal and distal portions, the floating sleeve having a second mechanical property different from the first mechanical property, wherein the floating sleeve is configured to move relative to the frame member. The catheter body is configured to deflect between an initial configuration and a deflection configuration: in the initial configuration, the floating sleeve and the frame member cooperatively support the catheter assembly; and in the deflection configuration, the floating segment frictionally engages with the frame member according to the degree of deflection, and the frictional engagement supports the catheter assembly according to the degree of deflection.

[0125] Aspect 28 may include the subject matter of aspect 27 or may optionally be combined with the subject matter of aspect 27 to optionally include a conduit assembly, wherein the first mechanical property or the second mechanical property includes at least one of yield strength, tensile strength, hardness, and Young's modulus.

[0126] An aspect may include the subject of aspect 27 or may optionally be combined with the subject of aspect 27 to optionally include a conduit assembly, wherein the conduit body is configured to be propelled as the conduit body deflects between an initial configuration and a deflection configuration.

[0127] Aspect 30 may include the subject of aspect 27 or may optionally be combined with the subject of aspect 27 to optionally include a conduit assembly, wherein the initial configuration has a gap between the floating section and the corresponding section of the frame member.

[0128] Aspect 31 may include a method of applying a catheter assembly, the method including, for example, inserting the catheter assembly into a passage, the catheter assembly including a frame member and a floating sleeve coupled around the frame member, wherein the frame member and the floating sleeve are movable relative to each other; navigating the catheter assembly along the passage toward a designated location, wherein navigating the catheter assembly includes: pushing the catheter assembly from a proximal catheter tip, wherein the floating sleeve and the frame member cooperatively support the catheter assembly; and deflecting the catheter assembly into a deflection configuration, wherein the floating sleeve frictionally engages with the frame member according to the degree of deflection, and the frictional engagement supports the catheter assembly according to the degree of deflection.

[0129] Aspect 32 may include the subject of aspect 27 or may optionally be combined with the subject of aspect 27 to optionally include a method wherein the floating sleeve includes one or more floating sections divided by one or more anchoring sections.

[0130] Aspect 33 may include the subject of aspect 27 or may optionally be combined with the subject of aspect 27 to optionally include a method wherein the actuation conduit assembly includes retractably hinged one or more floating segments relative to the frame member.

[0131] Aspect 34 may include the subject matter of aspect 27 or may optionally be combined with the subject matter of aspect 27 to optionally include a method that further includes guiding the guide tube assembly with a guidewire.

[0132] Aspect 35 may include the subject of aspect 27 or may optionally be combined with the subject of aspect 27 to optionally include a method that further includes hinged conduit assembly via a quick-swap port.

[0133] Each of these non-restrictive aspects can exist independently or can be combined in various arrangements or in combination with one or more other aspects.

[0134] The above description includes reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are referred to herein as “aspects” or “examples.” Such aspects or examples may include elements other than those shown or described. However, the inventors also contemplate aspects or examples in which only those elements shown or described are provided. Furthermore, the inventors contemplate examples of any combination or arrangement of those elements (or one or more features of those elements) shown or described with respect to a particular aspect or example (or one or more features of that particular example) or with respect to other aspects shown or described herein (or one or more features of other aspects).

[0135] In the event of any inconsistency between the usage in this document and any other document incorporated by reference, the usage in this document shall prevail.

[0136] In this document, as is common in patent literature, the terms "a" or "one" are used to include one or more, regardless of any other instance or use of "at least one" or "one or more". In this document, unless otherwise indicated, the term "or" is used to indicate a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "comprising" and "in..." are used as concise linguistic equivalents to the corresponding terms "including" and "wherein". Furthermore, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or process that includes elements other than those listed after this term in a claim is still considered to fall within the scope of that claim. Moreover, in the appended claims, the terms "first", "second", and "third", etc., are used only as designations and are not intended to impose numerical requirements on their objects.

[0137] Unless the context otherwise indicates, geometric terms such as “parallel,” “perpendicular,” “circular,” or “square” are not intended to require absolute mathematical precision. Instead, these geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “circular” or “approximately circular,” parts that are not precisely circular (e.g., parts that are slightly elliptical or polygonal) are still included in that description.

[0138] The above description is intended to be illustrative and not restrictive. For example, the foregoing aspects or examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used by one of ordinary skill in the art upon review of the above description, for example. An abstract is provided to conform to 37C.FR §1.72(b) to allow the reader to quickly determine the nature of the technical disclosure. The abstract is submitted on the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the specific description above, various features may be combined to organize the disclosure. This should not be construed as meaning that all unclaimed features are necessary for any claim. Rather, the inventive subject matter may consist of fewer features than all of the particular disclosed embodiments. Therefore, the appended claims are thus incorporated into the detailed description as aspects, examples, or embodiments, wherein each claim is an independent, separate embodiment, and such embodiments are contemplated to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of equivalents conferred by such claims.

Claims

1. A catheter assembly, comprising: A catheter body extending distally from a position near the hub of the catheter assembly, the distal portion having a distal tip assembly, the catheter body comprising: A frame member extending between a proximal portion and a distal portion. And located proximal to the distal end assembly, the frame member has a first mechanical property; and A floating sleeve, which is connected around the frame member and extends between the proximal and distal portions and is located proximal to the distal tip assembly, has a second mechanical property different from the first mechanical property, making the floating sleeve more flexible than the frame member; The floating sleeve includes at least one floating section and one or more anchoring sections along the conduit body. The at least one floating section of the floating sleeve is movable relative to the frame member, and the one or more anchoring sections of the floating sleeve are interconnected with the frame member.

2. The catheter assembly according to claim 1, wherein, The catheter body includes an initial configuration and a deflection configuration: In the initial configuration, the floating sleeve and the frame member cooperate to support the conduit assembly. In the deflection configuration, the catheter body is deflected relative to the initial configuration, and at least a portion of the floating sleeve frictionally engages with the frame member depending on the degree of deflection.

3. The catheter assembly according to claim 1, wherein, The at least one floating section of the floating sleeve can be hinged in a telescopic manner.

4. The catheter assembly according to claim 1, further comprising a gap between the floating sleeve and the frame member.

5. The catheter assembly according to claim 1, wherein, The frame member is capable of sliding within the floating sleeve.

6. The catheter assembly according to claim 1, wherein, The frame components include hysteresis tubes, reinforcing wires, braids, coils, internal polymer linings, or combinations thereof.

7. The catheter assembly according to claim 1, wherein, The floating sleeve includes a distal floating sleeve section and a proximal floating sleeve section, wherein the rigidity of the distal floating sleeve section is less than that of the proximal floating sleeve section.

8. The catheter assembly according to claim 7, wherein, The floating sleeve also includes a connecting portion that connects the distal floating sleeve section to the proximal floating sleeve section.

9. The catheter assembly according to claim 1, wherein, The frame member includes a helical cut portion, which comprises a continuous cut portion surrounding the outer surface of the frame member.

10. The catheter assembly of claim 9, wherein, The helical cutting portion includes a first pitch angle and a second pitch angle, the second pitch angle being smaller than the first pitch angle, and wherein the helical cutting portion gradually changes from the first pitch angle to the second pitch angle along the frame member from the distal portion of the catheter assembly to the proximal portion of the catheter assembly.

11. The catheter assembly of claim 9, wherein, The helical cutting portion includes a first pitch width and a second pitch width, the second pitch width being greater than the first pitch width, and wherein the helical cutting portion gradually changes from the first pitch width to the second pitch width along the frame member from the distal portion of the catheter assembly to the proximal portion of the catheter assembly.

12. The catheter assembly of claim 1, wherein, The one or more anchoring sections include a first anchoring section located near the proximal portion of the catheter assembly, a second anchoring section located between the proximal portion of the catheter assembly and the distal portion of the catheter assembly, and a third anchoring section located near the distal portion of the catheter assembly.

13. The catheter assembly of claim 12, wherein, The first anchorage section, the second anchorage section, and the third anchorage section allow the frame member to move within the floating sleeve and between the first anchorage section, the second anchorage section, and the third anchorage section.

14. The catheter assembly of claim 1, further comprising a quick-change port located on the distal portion of the catheter assembly.

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