Locking structure for a medical device assembly and medical device assembly

Abstract

This application relates to the field of medical device technology, specifically disclosing a locking structure for a medical device assembly and the medical device assembly itself. The medical device assembly includes a first device and a second device that are inserted into each other. The locking structure includes: a locking hole in the first device; a locking member in the second device that is inserted into the locking hole, the locking member having a deformable structure and having a transition state and a locked state, wherein the locking member is inserted through the locking hole in the transition state and is located in the locking hole in the locked state; and a retaining member that holds the locking member in the locked state to prevent the locking member from disengaging from the locking hole. The locking structure in this application uses an axial insertion method, which simplifies operation and, in a preferred embodiment, enhances reliability, providing a safer and more efficient device engagement solution for interventional surgery.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to locking structures for medical device components and medical device components. Background Technology

[0002] In the field of interventional medical devices, the synergistic cooperation between the catheter sheath and the dilator is one of the steps to establish vascular access. When in use, the catheter sheath first enters the body to build a temporary channel, and then the dilator is delivered through the catheter sheath to expand the intra-body interventional channel.

[0003] After the dilator is inserted into the catheter sheath, existing technologies generally employ a rotation-locking structure to maintain their relative positions. This involves rotating the dilator relative to the catheter sheath and locking them together using threads, elastic clips, or other engaging mechanisms. However, this rotation-locking method has revealed some drawbacks in clinical applications. For example, the rotational motion can easily cause unnecessary axial displacement of the catheter sheath or dilator, especially when adjusting its position after puncture, potentially leading to damage to the vessel wall. Furthermore, it makes rapid separation difficult when necessary, delaying the appropriate procedure. Summary of the Invention To address the problems of the prior art, this application provides a locking structure that simplifies the operation process and improves locking reliability. Applicable medical device components include, but are not limited to, catheter sheaths and dilators.

[0004] This application provides a catheter sheath having opposing distal and proximal ends, and an axial direction extending between the distal and proximal ends. The catheter sheath includes a first connector and a sheath tube extending distally from the first connector, wherein the first connector has a locking hole extending axially and opening toward the proximal side, the locking hole for receiving a locking member inserted axially.

[0005] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0006] Optionally, the first connector includes: The outer casing has an internal instrument channel communicating with the sheath. A sealing membrane is located inside the housing and arranged around the instrument channel, and a fluid cavity is formed between the sealing membrane and the housing. The fluid cavity is used to inject fluid to drive the sealing membrane to close the instrument channel.

[0007] Optionally, the portion of the outer casing located on the outer periphery of the fluid cavity is cylindrical.

[0008] Optionally, the portion of the outer shell located on the outer periphery of the fluid cavity is an elastic segment. Under normal pressure, the elastic segment of the fluid cavity is cylindrical, and the elastic segment deforms accordingly when the fluid cavity is filled with fluid.

[0009] Optionally, the sealing membrane is tubular and its two axial ends are sealed to the housing to define the fluid cavity.

[0010] Optionally, the keyhole is formed in the housing.

[0011] Optionally, the proximal end of the sealing membrane is fixed to the outer shell by an annular end cap, and the locking hole is formed in the end cap.

[0012] Optionally, the lock hole is provided with a stepped structure for engaging the lock.

[0013] Optionally, at least two keyholes are arranged at circumferential intervals.

[0014] Optionally, the catheter sheath further includes: An intermediate sleeve, along the axial direction, is connected between the sheath and the outer shell; The intermediate sleeve is provided with a first connector that communicates with the sheath, and the outer shell is provided with a second connector that communicates with the fluid cavity.

[0015] Optionally, the distal end of the sealing membrane is clamped and fixed between the intermediate sleeve and the outer shell.

[0016] Optionally, a tube connector is fixed to the proximal end of the sheath and connected to the distal end of the intermediate sleeve via the tube connector.

[0017] This application also provides an expander having opposing distal and proximal ends, and an axial direction extending between the distal and proximal ends, the expander including a second connecting seat and a rod extending distally from the second connecting seat, wherein the second connecting seat is provided with a locking member extending axially toward the distal end. The locking element is used to be inserted axially into a matching lock hole and kept locked.

[0018] This application also provides an expander having opposing distal and proximal ends, and an axial extension between the distal and proximal ends, the expander comprising: The second connecting seat is provided with a locking member. The locking member has a deformable structure and has a relative transition state and a locked state. The locking member is inserted through the corresponding lock hole in the transition state and is located in the corresponding lock hole in the locked state. The rod is fixed to the second connecting seat and extends further to the distal end; A retainer, movably mounted on the second connector, is used to suppress deformation of the locking member and keep the locking member in the locked state.

[0019] This application also provides an expander having opposing distal and proximal ends, and an axial extension between the distal and proximal ends, the expander comprising: The second connecting seat is provided with a locking element, which is used to be inserted into a corresponding lock hole; The rod is fixed to the second connecting seat and extends further to the distal end; A retainer is slidably mounted on the second connecting seat to maintain the insertion and engagement of the lock member with the lock hole, wherein the sliding direction of the retainer is parallel to the insertion direction of the lock member.

[0020] Optionally, the rod body is a solid structure or has an axially extending through hole.

[0021] Optionally, the second connector includes: A fixing sleeve is attached to the proximal end of the rod. The annular portion protrudes from the outer periphery of the fixing sleeve; The locking element is fixed to the annular portion and extends distally.

[0022] Optionally, the rod body has an axially extending through hole, and the proximal side of the annular portion is provided with a Luer connector that communicates with the through hole.

[0023] Optionally, the expander further includes: A retainer, slidably mounted on the second connecting seat, is used to hold the lock in a locked state to prevent the lock from disengaging from the keyhole.

[0024] Optionally, the retaining member has the following characteristics relative to the locking member: Lock position, contact the locking element and keep the locking element in the locked state; The unlock position allows the lock to move towards a transition state.

[0025] Optionally, the retainer includes: The sliding seat is annular and slidably sleeved on the outer periphery of the second connecting seat; The actuating part extends from the sliding seat to the distal end, and in the locked position, the actuating part abuts against the locking member.

[0026] Optionally, a guide structure is provided between the inner edge of the sliding seat and the outer periphery of the second connecting seat to guide axial relative movement.

[0027] Optionally, the guide structure includes: A guide groove is provided in one of the sliding seat and the second connecting seat; A guide rib is slidably fitted along the guide groove, and the guide rib is disposed on the other of the sliding seat and the second connecting seat.

[0028] Optionally, an axial limiting structure is provided between the inner edge of the sliding seat and the outer periphery of the second connecting seat to restrict the sliding stroke of the retainer.

[0029] Optionally, the axial limiting structure includes mutually cooperating positioning teeth.

[0030] Optionally, the positioning teeth are arranged in the guide groove and / or disposed on the guide rib.

[0031] Optionally, the positioning teeth include: A first positioning tooth is disposed on the retainer; The second positioning teeth are disposed on the second connecting seat, wherein there are multiple second positioning teeth and at least two retaining positions, so that the retaining member is in a locked position and an unlocked position respectively.

[0032] Optionally, in the locked position, the actuating part abuts against the locking member.

[0033] Optionally, the functional part is block-shaped or strip-shaped extending along the axial direction.

[0034] Optionally, the actuating part abuts against one side or at least both sides of the locking member.

[0035] Optionally, the actuating part partially surrounds the locking element.

[0036] Optionally, the functional part is a strip extending axially and has a C-shaped cross-section.

[0037] Optionally, the expander also has radial and circumferential components corresponding to the axial direction, and the deformation direction of the locking member has radial and / or circumferential components.

[0038] Optionally, the deformation mode of the locking element is unidirectional bending or scaling along two opposite directions.

[0039] Optionally, the locking element has a preset shape and tends to conform to the preset shape in the locked state.

[0040] Optionally, the locking element includes: An extension arm extends from the second connecting seat to the distal end; The hook-shaped portion is located at the end of the extended arm; In the transition state, the extension arm deforms and allows the hook-shaped portion to pass through the keyhole from the proximal end to the distal end. In the locked state, the hook-shaped portion is restricted by the edge of the keyhole on the distal end side of the keyhole.

[0041] Optionally, the extension arm is arranged at a distance from the outer periphery of the fixed sleeve.

[0042] Optionally, the proximal end of the extension arm is fixed to the distal end of the annular portion, and the hook-shaped portion is located on the distal end of the extension arm.

[0043] Optionally, the distal end of the hook-shaped portion has a guide bevel to guide itself through the keyhole.

[0044] Optionally, the locking member retracts in circumferential shape in the transition state relative to the locked state, and the retaining member restricts the shape retraction of the locking member in the locked position.

[0045] Optionally, the locking member expands outward in circumferential shape in the transition state relative to the locked state, and the retaining member restricts the shape of the locking member to close in the locked position.

[0046] Optionally, the extension arms are two arms arranged side by side, and the working part is located between the two extension arms, wherein: In the locked position, a portion of the retainer is located between the hook-shaped portions of the two extension arms, preventing the hook-shaped portions of the two extension arms from approaching each other and thus maintaining the locked state. In the unlocked position, the retainer moves out between the hook-shaped portions of the two extension arms, allowing the hook-shaped portions of the two extension arms to come closer together, i.e., tending towards a transition state.

[0047] Optionally, the hook-shaped portions of the two extension arms protrude in opposite directions and are obstructed by the two opposite edges of the lock hole in the locked state.

[0048] Optionally, the extension arm has a radial inner side and an outer side, the hook-shaped portion protrudes inward, and the distal end of the extension arm is radially outward in the transition state relative to the locked state.

[0049] Optionally, the retainer abuts against the radially outer side of the hook portion in the locked position.

[0050] Optionally, the actuating portion partially surrounds the extending arm.

[0051] Optionally, the second connector includes: The inner cylinder, with the proximal end of the rod inserted and fixed inside the inner cylinder; The outer cylinder is fixedly sleeved on the outer periphery of the inner cylinder, and the locking member is connected to the outer cylinder.

[0052] Optionally, the locking element and the positioning teeth are arranged alternately along the circumference of the outer cylinder.

[0053] Optionally, the retainer is slidably sleeved on the outer periphery of the outer cylinder, and the inner side of the retainer is provided with a supporting rib that slides against the outer wall of the outer cylinder.

[0054] This application also provides a medical device assembly having opposing distal and proximal ends, and an axial direction extending between the distal and proximal ends. The medical device assembly includes a dilator and a catheter sheath that guides the delivery of the dilator. The dilator and the catheter sheath are provided with a locking structure for axial insertion and withdrawal to maintain their relative positions.

[0055] In the medical device components of this application, any of the dilators and catheter sheaths described above may be used.

[0056] This application also provides a locking structure for a medical device assembly, the medical device assembly including a first device and a second device that are inserted and mated, the locking structure including: The keyhole is located in the first instrument. A locking element is disposed on the second instrument and inserted into the keyhole. The locking element has a deformable structure and has a relative transition state and a locked state, wherein the locking element is inserted through the keyhole in the transition state and is located in the keyhole in the locked state. A retainer is provided to keep the locking member in the locked state, thereby preventing the locking member from disengaging from the keyhole.

[0057] This application also provides a locking structure for a medical device assembly, the medical device assembly including a first device and a second device that are inserted and mated, the locking structure including: The keyhole is located in the first instrument. A locking element is disposed on the second instrument and is inserted into the lock hole; A retainer is slidably mounted on the second instrument to maintain the insertion and engagement of the lock member with the lock hole, wherein the sliding direction of the retainer is parallel to the insertion direction of the lock member.

[0058] Optionally, the medical device assembly has opposing distal and proximal ends, and an axial direction extending between the distal and proximal ends, wherein the locking hole and the locking member are axially inserted into each other.

[0059] Optionally, the first device is a catheter sheath, and the second device is a dilator delivered to a predetermined location via the catheter sheath; The catheter sheath includes a first connector and a sheath extending distally from the first connector, with a locking hole located at the first connector and opening towards the proximal side; The expander includes a second connector and a rod extending distally from the second connector, the locking element being located on the second connector and extending distally.

[0060] This application also provides a sheath, including a tube body, wherein a section of the tube body is an expandable section, the expandable section comprising: The inner layer, along the circumference of the tube, has one or more bends arranged at intervals. Reinforcing ribs are located outside the inner layer and are alternately arranged with the meandering portion in the circumferential direction of the tube body; The outer layer, which wraps around the inner layer and the outer periphery of the reinforcing rib; The expandable section has an outward expansion state with radial deformation after expansion. In the outward expansion state, the meandering part tends to unfold, and the corresponding part of the outer layer adapts to deformation or expansion and cracking.

[0061] Optionally, the tube has a distal end and a proximal end, and from the distal end to the proximal end, it includes a distal segment, the expandable segment, and a proximal segment in sequence, wherein the distal side of the reinforcing rib extends only to the junction of the distal segment and the expandable segment, and the distal segment itself is capable of deformation or cracking.

[0062] Optionally, along the circumference of the tube, there are 2 to 6 reinforcing ribs arranged at intervals, and each reinforcing rib extends along the length of the tube.

[0063] Optionally, the proximal ends of each of the reinforcing ribs are connected to form a ring-shaped junction.

[0064] Optionally, the proximal side of the reinforcing rib extends only to the junction of the proximal segment and the expandable segment.

[0065] Optionally, the expandable segment gradually expands in diameter near the proximal segment until it connects with the proximal segment, and the degree of detour in the circumferential direction of the detour portion gradually decreases as the expandable segment gradually expands in diameter.

[0066] Optionally, the inner layer is made of PTFE material, and the outer layer and the reinforcing ribs can both be made of Pebax material.

[0067] This application also provides a catheter sheath having opposing distal and proximal ends, and an axial direction extending between the distal and proximal ends, the catheter sheath including a first connector and a sheath extending distally from the first connector, wherein the sheath is the sheath described in various embodiments of this application.

[0068] In the locking structure of this application, the first instrument and the second instrument may be either the dilator and the catheter sheath described above.

[0069] This application also provides a medical device assembly having any of the locking structures described above.

[0070] The locking structure in this application adopts an axial insertion method, which simplifies the operation and enhances reliability in the preferred embodiment, providing a safer and more efficient instrument matching solution for interventional surgery. Attached Figure Description To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0071] Figure 1 This is a schematic diagram of the structure of a medical device component in one embodiment of this application; Figure 2 This is a schematic diagram of the structure of the catheter sheath in one embodiment of this application; Figure 3 This is a schematic diagram of the expander in one embodiment of this application; Figure 4 This is a schematic diagram of the structure of the proximal portion of a medical device component (with the retainer in the unlocked position) in one embodiment of this application; Figure 5 for Figure 4 Sectional view of AA in the middle; Figure 6 for Figure 4 A schematic diagram of the structure in which the retainer is in the locked position; Figure 7 for Figure 6 Cross-sectional view of the middle section (BB); Figure 8 This is an exploded view of the first connecting seat in one embodiment of this application; Figure 9 for Figure 8 A schematic diagram of each component from another angle; Figure 10 This is an exploded view of the proximal portion (sheath and rod omitted) of a medical device component in one embodiment of this application; Figure 11 for Figure 10 A schematic diagram of each component from another angle; Figure 12 This is a schematic diagram of the proximal portion of the expander (with the retainer in the unlocked position) in one embodiment of this application; Figure 13 for Figure 12 A diagram illustrating the retainer switching to the locked position; Figure 14This is a schematic diagram of the second connecting seat and adjusting member in one embodiment of this application; Figure 15 for Figure 14 A schematic diagram of each component from another angle; Figure 16 This is an exploded view of the proximal portion (sheath and rod omitted) of a medical device component in another embodiment of this application; Figure 17 for Figure 16 A schematic diagram of each component from another angle; Figure 18 for Figure 16 A schematic diagram showing the assembled components (with the retainer in the unlocked position); Figure 19 for Figure 18 CC section view; Figure 20 for Figure 18 A schematic diagram showing the retaining element in the locked position; Figure 21 for Figure 20 Cross-sectional view of DD.

[0072] Figure 22 This is an exploded view of the proximal portion (sheath and rod omitted) of a medical device component in another embodiment of this application; Figure 23 for Figure 22 A schematic diagram of the middle retainer and the second connecting seat from another angle; Figure 24 for Figure 22 A schematic diagram showing the assembled components (with the retainer in the unlocked position); Figure 25 for Figure 24 EE cross-section; Figure 26 for Figure 25 A schematic diagram showing the retaining element in the locked position; Figure 27 This is a schematic diagram of the structure of a sheath according to an embodiment of this application; Figure 28 for Figure 27 Schematic diagram of the FF section; Figure 29 This is a schematic diagram showing the unfolded reinforcing rib inside the sheath according to an embodiment of this application; Figure 30 for Figure 27 A schematic diagram showing the exposed reinforcing ribs behind the omitted inner and outer layers of the sheath; Figure 31 for Figure 30 Enlarged view of part A in the image.

[0073] The component labels are as follows: 100. Catheter sheath; 110. First connector; 111. Outer shell; 112. Instrument channel; 113. Second connector; 114. Elastic segment; 115. Locking hole; 116. Sealing membrane; 117. Fluid chamber; 118. End cap; 119. Stepped structure; 120. Sheath; 120a. Proximal segment; 120b. Expandable segment; 120c. Distal segment; 121. Inner layer; 1211. Bypass; 122. Outer layer; 123. Reinforcing rib; 124. Confluence; 130. Intermediate sleeve; 131. First connector; 140. Tube connector; 200. Expander; 210. Second connecting seat; 210a. Inner cylinder; 210b. Outer cylinder; 211. Fixing sleeve; 212. Annular part; 213. Locking element; 214. Extension arm; 215. Hook-shaped part; 216. Guide slope; 217. Guide rib; 218. Luer connector; 219. Second positioning tooth; 220. Rod body; 300, retainer; 310, sliding seat; 311, guide groove; 312, first positioning tooth; 313, support rib; 320, actuating part. Detailed Implementation

[0074] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0075] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0076] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0077] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0078] When used to indicate direction, the proximal end generally refers to the side closest to the operator (e.g., a doctor), and the distal end is the side relatively far away. Along the interventional path, each component itself has a relative distal and proximal end. Theoretically, when the catheter assembly and control handle are fully straightened, the straight line between the proximal and distal ends determines the axis, and correspondingly, the radial direction perpendicular to the axis and the circumferential direction arranged around the axis are also determined. When used to refer to a structure, the "end" in the text indicates the endpoint of the structure or a point or region in that lateral direction, or a specific structure connected to that point or region.

[0079] See Figure 1 In order to improve the locking method between multiple medical devices and ensure the locking effect to limit their relative positional relationship, one embodiment of this application provides a medical device assembly, particularly an interventional medical device assembly. The medical device assembly has a distal end and a proximal end, as well as an axial direction extending between the distal end and the proximal end, and also has a radial and circumferential direction corresponding to the axial direction. The medical device assembly includes an expander and a catheter sheath that guides the delivery of the expander. Both the expander and the catheter sheath are provided with a locking structure for axial insertion and withdrawal to maintain their relative position.

[0080] The catheter sheath includes a first connecting seat 110 and a sheath tube 120 extending distally from the first connecting seat 110. The dilator includes a second connecting seat 210 and a rod 220 extending distally from the second connecting seat 210. When the dilator and the catheter sheath are used together, the rod 220 passes through the first connecting seat 110 and the sheath tube 120 sequentially from the proximal end to the distal end until the second connecting seat 210 is adjacent to the first connecting seat 110. In order to maintain the relative positional relationship between the dilator and the catheter sheath, a locking structure is provided between the first connecting seat 110 and the second connecting seat 210. For example, the first connecting seat 110 is provided with a locking hole that opens towards the proximal end, and the second connecting seat 210 is provided with a locking member that extends distally and can be inserted into the locking hole.

[0081] The locking structure in this embodiment features an axial insertion-extraction engagement, significantly improving operational efficiency and convenience. The axial insertion engagement requires no rotation; locking is achieved simply by pushing in a straight line. When the first connecting seat 110 and the second connecting seat 210 are close together, it can even be completed with one hand, reducing operational steps and increasing efficiency. Similarly, the unlocking process only requires pulling out in the opposite axial direction, solving problems such as jamming that may occur with traditional rotating structures, and providing structural assurance for rapid separation of instruments in emergency situations. See Figure 2 (combined) Figure 10 , Figure 11 (Related parts in the middle), one embodiment of this application provides a catheter sheath 100, which can be used to construct a temporary channel during interventional surgery. The catheter sheath 100 of this embodiment has a distal end and a proximal end, and an axial direction extending between the distal end and the proximal end. The catheter sheath 100 includes a first connecting seat 110 and a sheath tube 120 extending distally from the first connecting seat 110. The first connecting seat 110 is provided with a locking hole 115 extending axially and opening towards the proximal side. The locking hole 115 is used to receive a locking member 213 inserted axially and keep it in a locked state.

[0082] Based on the same inventive concept, see [link to inventive concept] Figure 3 (combined) Figure 10 , Figure 11 (Relevant parts in the middle), one embodiment of this application provides an expander 200, having a distal end and a proximal end, and an axial direction extending between the distal end and the proximal end. The expander 200 includes a second connecting seat 210 and a rod 220 extending distally from the second connecting seat 210, wherein the rod 220 is a solid structure or has an axially extending through hole. The rod 220 is configured with a preset outer diameter and scale as needed, and may also be provided with imaging marks to cooperate with imaging equipment to display the position or posture inside the body. The distal end of the rod 220 has a convergent shape to facilitate guidance and delivery. As for the rod 220 itself, its material and structure can be implemented in combination with existing technology.

[0083] The second connecting seat 210 is provided with a locking member 213 extending axially toward the distal end. The locking member 213 is used to be inserted axially into the matching lock hole 115 and kept in a locked state. The locking member 213 can be held in the lock hole 115 by means of elastic hooks, plug pins, etc.

[0084] The catheter sheath 100 and dilator 200 in various embodiments of this application can form a medical device assembly and be locked or released from each other by axial insertion and removal. In other embodiments, the medical device assembly may also use other types of instruments.

[0085] See Figures 4-9 In one embodiment of this application, the first connector 110 includes a housing 111 and a sealing membrane 116.

[0086] The outer shell 111 has an instrument channel 112 that communicates with the sheath 120. The outer shell 111 can be a tubular structure as a whole and provides the instrument channel 112 inside. The tubular structure is not strictly limited in cross-sectional shape. For example, the cross-section can be circular, elliptical, etc. The cross-sectional shape of the tubular structure at different parts along the axial direction can be the same everywhere or vary. When it varies, it can be a bellows or a configuration with an expansion in the middle of the axial direction.

[0087] The sealing membrane 116 is located inside the housing 111 and arranged around the instrument channel 112. The sealing membrane 116 and the housing 111 form a fluid cavity 117, which is used to inject fluid to drive the sealing membrane 116 to close the instrument channel 112.

[0088] When in use, the dilator 200 extends through the instrument channel 112 and passes through the sheath 120 until it extends out of the sheath 120 from the distal end. It can dilate the sheath 120 itself as well as blood vessels or other internal cavities. When the dilator 200 is not inserted, the sealing membrane 116 closes the instrument channel 112 under the action of fluid. When the dilator 200 is inserted, the sealing membrane 116 is tightened around the rod 220 under the action of fluid to achieve a seal, that is, it acts as a hemostatic valve.

[0089] In this embodiment, the sheath 120 is sequentially connected to the outer shell 111 via a pipe connector 140 and an intermediate sleeve 130. The proximal end of the sheath 120 is fixed to the pipe connector 140, which is connected to the distal end of the intermediate sleeve 130. The connection methods between adjacent components of the sheath 120, pipe connector 140, intermediate sleeve 130, and outer shell 111 include, but are not limited to, threaded connections, adhesive bonding, tight fits, and bayonet connections. For preoperative air venting or signal acquisition, the side wall of the intermediate sleeve 130 is provided with a first connector 131 communicating with the sheath 120. For example, during air venting, liquid can be injected through the first connector 131, filling the sheath 120 until it is discharged from the distal end. To achieve a seal on the instrument channel 112, the outer shell 111 is provided with a second connector 113 communicating with the fluid chamber 117, used to supply fluid to the fluid chamber 117 to drive the sealing membrane 116. The first connector 131 and the second connector 113 can be externally connected to extension tubing or control valves, etc., as needed.

[0090] The sealing membrane 116 is tubular and its two axial ends are sealed to the outer shell 111 to define the fluid cavity 117. The sealing membrane 116 itself can be made of existing materials. The distal end of the sealing membrane 116 is clamped and fixed between the intermediate sleeve 130 and the outer shell 111, and the proximal end of the sealing membrane 116 is fixed to the outer shell 111 by an annular end cap 118. In this embodiment, the locking hole 115 is formed in the end cap 118.

[0091] To ensure the locking effect, at least two lock holes 115 are arranged at intervals along the circumference, for example, 2 to 4 are evenly arranged along the circumference. The lock holes 115 are provided with a stepped structure 119 for the locking member 213 to engage, which can accommodate the insertion of the locking member 213 within the thickness range of the end cap 118, so that the locking member 213 does not extend beyond the far end of the end cap 118 after it is in place, thus avoiding interference with other components.

[0092] As one improvement, in one embodiment of this application, the portion of the outer shell 111 located on the outer periphery of the fluid cavity 117 is an elastic segment 114 (i.e., made of elastic material and deformable according to fluid pressure). Under normal pressure, the elastic segment 114 of the fluid cavity 117 is cylindrical (with a generally straight generatrix). When the fluid cavity 117 is filled with fluid, the elastic segment 114 deforms accordingly. The cylindrical elastic segment 114, relative to the converging waist shape in the middle, can further increase the initial volume of the fluid cavity 117 and improve the sensitivity of the sealing membrane 116 in the initial stage of deformation.

[0093] In another embodiment of this application, the outer shell 111 is made of a rigid material and maintains its shape during use. When the sealing membrane 116 is compressed, the fluid (e.g., gas) can change its volume to adapt to the changes in the fluid cavity 117. If the fluid used is incompressible, the second connector 113 of the outer shell 111 can be connected to an external buffer mechanism to temporarily store fluid leakage caused by pressure and volume changes in the fluid cavity 117. In some cases, fluid pressure changes can also be adaptively buffered by the deformation of different parts of the sealing membrane 116.

[0094] Further integration Figures 10-15 In another embodiment of this application, an expander 200 is also provided, having opposing distal and proximal ends, and an axial extension between the distal and proximal ends. The expander 200 of this embodiment includes: The second connecting seat 210 is provided with a locking member 213. The locking member 213 has a deformable structure and has a relative transition state and a locked state. The locking member 213 is inserted through the corresponding lock hole 115 in the transition state and is located in the corresponding lock hole 115 in the locked state. The rod 220 is fixed to the second connecting seat 210 and extends further to the distal end; The retainer 300 is movably mounted on the second connecting seat 210 and is used to suppress the deformation of the locking member 213 and keep the locking member 213 in the locked state.

[0095] In this embodiment, the lock 213 adopts a deformable structure. During the locking process, it can only pass through the lock hole 115 after deforming from a preset shape (i.e., the initial shape) to a transition state. After the lock 213 passes through the lock hole 115 and is locked in place, it returns to the locked state. The retaining member 300 has an unlocked position and a locked position relative to the lock 213. In the locked position, it acts on the lock 213 to restrict its deformation and keep it in the locked state. Since the lock 213 cannot deform to the transition state at this time, it can prevent it from coming out of the lock hole 115, thus ensuring the stability and effectiveness of the locking.

[0096] When unlocking is required, retainer 300 switches to the unlock position, which releases the restriction on lock 213, and then drives lock 213 to disengage from lock hole 115. Since there is no restraint from retainer 300, lock 213 can adaptably deform and pass through and disengage from lock hole 115.

[0097] In another embodiment, this application also provides an expander 200 having opposing distal and proximal ends, and an axial extension between the distal and proximal ends. The expander 200 of this embodiment includes: The second connecting seat 210 is provided with a locking member 213, which is used to be inserted into the corresponding lock hole 115. The rod 220 is fixed to the second connecting seat 210 and extends further to the distal end; The retainer 300 is slidably mounted on the second connecting seat 210 and is used to hold the locking member 213 in engagement with the lock hole 115, wherein the sliding direction of the retainer 300 is parallel to the insertion direction of the locking member 213. For example, both are axial movements.

[0098] The parallel movement of the retainer 300 and the locking member 213 facilitates operation and avoids unexpected deviations in other directions. This is especially beneficial after intervention, reducing disturbance to the puncture site and further minimizing safety risks. For example, when used in conjunction with the catheter sheath 100 mentioned earlier, the second connecting seat 210 is first pushed distally along the axial direction until the locking member 213 is inserted into the locking hole 115 and pre-positioned. Then, the retainer 300 is pushed distally along the axial direction until it acts on the locking member 213 to prevent it from disengaging from the locking hole 115. During this process, the pre-positioning of the locking member 213 and the locking of the retainer 300 are performed in the same direction, allowing for continuous operation and improved efficiency. The same principle applies when releasing the locking mechanism.

[0099] In one embodiment, the second connector 210 includes: The fixing sleeve 211 is fixedly fitted to the proximal end of the rod body 220, wherein the rod body 220 has an axially extending through hole for the passage of guide wires or fluid, etc. The annular portion 212 protrudes from the outer periphery of the fixed sleeve 211, and the proximal end of the annular portion 212 is provided with a Luer connector 218 that communicates with the through hole. Lock 213 is fixed to the distal end of the annular portion 212 and extends further distally.

[0100] In one embodiment, the retainer 300 includes: The sliding seat 310 is annular and slidably sleeved on the outer periphery of the second connecting seat 210. An anti-slip structure can be provided on the outer periphery of the sliding seat 310 to facilitate operation. The action part 320 extends from the sliding seat 310 to the distal end. In the locked position, the action part 320 abuts against the lock member 213 to prevent it from disengaging from the lock hole.

[0101] An axial limiting structure is also provided between the inner edge of the sliding seat 310 and the outer periphery of the second connecting seat 210 to limit the sliding stroke of the retainer 300. For example, the axial limiting structure includes mutually cooperating positioning teeth. Specifically, it includes: The first positioning tooth 312 is fixed to the inner edge of the sliding seat 310; The second positioning tooth 219 is fixed to the outer periphery of the second connecting seat 210.

[0102] For a compact structure and mutual coordination, the first positioning tooth 312 is located in the guide groove 311, the guide ribs 217 are two parallel ones, and the second positioning tooth 219 is at least two and is located between the two guide ribs 217.

[0103] contrast Figure 4 and Figure 6 (and comparison) Figure 5 and Figure 7 As can be seen, the retaining member 300 has relative to the locking member 213 Figure 4 The indicated unlock location and Figure 5 The schematic locking position shows that there are three second positioning teeth 219. In the unlocked position, the first positioning tooth 312 is blocked by the second positioning tooth 219 on the right. In the locked position, the first positioning tooth 312 is located between the two second positioning teeth 219 on the left. The axial limiting structure that cooperates with each other can provide tactile feedback and prevent the slide seat 310 from moving unexpectedly.

[0104] In the locked position, retainer 300 contacts lock 213 and keeps lock 213 in the locked state; in the unlocked position, retainer 300 allows lock 213 to move towards the transition state.

[0105] The retainer 300 mainly cooperates with the locking member 213 through the action part 320. For example, the action part 320 is block-shaped or strip-shaped extending along the axial direction. The action part 320 abuts against one side or at least both sides of the locking member 213.

[0106] See Figure 14 , Figure 15 To guide the sliding seat 310 to slide relative to the second connecting seat 210, a guide structure is provided between the inner edge of the sliding seat 310 and the outer periphery of the second connecting seat 210 to guide axial relative movement. For example, the guide structure includes: Guide groove 311 is provided on the inner edge of sliding seat 310; Guide rib 217 slides along guide groove 311 and is located on the outer periphery of second connecting seat 210.

[0107] The expander 200 has radial and circumferential components corresponding to the axial direction, and the deformation direction of the locking member 213 has at least radial and / or circumferential components. For example, the deformation mode of the locking member 213 is unidirectional bending or scaling along two opposite directions. Figure 14 , Figure 15 As can be seen from the above, the locking member 213 in one embodiment of this application includes: The extension arm 214 extends from the second connecting seat 210 to the distal end; The hook-shaped portion 215, located at the end of the extension arm 214, blocks and restricts the hook-shaped portion 215 from disengaging after the locking member 213 is in place. During locking, the extension arm 214 deforms, causing the locking member 213 to enter a transition state, allowing the hook-shaped portion 215 to pass through the lock hole 115 from the proximal end to the distal end. In the locked state, the hook-shaped portion 215 is restricted to the distal end of the lock hole 115 by the edge of the lock hole 115. During unlocking, the force of the retaining member 300 is released, allowing the extension arm 214 to deform and cause the locking member 213 to enter a transition state. The hook-shaped portion 215 accordingly avoids the edge of the lock hole 115, allowing the locking member 213 to pass through and disengage from the lock hole 115.

[0108] In one embodiment, the extension arm 214 and the outer periphery of the fixing sleeve 211 are arranged radially spaced apart, wherein the proximal end of the extension arm 214 is fixed to the annular portion 212, and the hook portion 215 is located at the distal end of the extension arm 214.

[0109] In one embodiment, the extension arms 214 are two arms arranged side by side, with hook-shaped portions 215 protruding in opposite directions. Each hook-shaped portion 215 has a guide slope 216 on its distal end to guide itself through the lock hole 115.

[0110] The actuating part 320 is slidably arranged between the two extending arms 214, wherein: In the locked position, the actuating part 320 is located between the hook-shaped parts 215 of the two extension arms 214, restricting the hook-shaped parts 215 of the two extension arms 214 from approaching each other, thus maintaining them in the locked state. In the unlocked position, the actuating part 320 moves out between the hook-shaped parts 215 of the two extension arms 214.

[0111] Before engaging with the lock hole 115, the hook-shaped portions 215 of the two extension arms 214 are in an initial state that is basically the same as the locked state, that is, the two hook-shaped portions 215 are relatively far apart and blocked by the edge of the lock hole 115. When inserted into the lock hole 115, the extension arms 214 deform under the pressure of the inner edge of the lock hole 115, that is, the two hook-shaped portions 215 are relatively close together, the lock 213 enters the transition state and can pass through the lock hole 115. After the hook-shaped portions 215 move to the far end of the lock hole, the pressure of the inner edge of the lock hole 115 is released, and the extension arms 214 deform back to the locked state, that is, the two hook-shaped portions 215 are relatively far apart and blocked by the two opposite edges of the lock hole 115.

[0112] Since the two extension arms 214 in this embodiment are arranged side by side in a circumferential direction, the locking member 213 shrinks in shape in the circumferential direction at least partially relative to the locked state in the transition state, and the action part 320 is located between the two hook-shaped parts 215 in the locked position, which can limit the shrinkage of the shape of the locking member 213.

[0113] In other embodiments, a single extension arm 214 may be used, in which case the actuating part 320 abuts against one side of the extension arm 214 in the locked position and suppresses deformation of the extension arm 214.

[0114] In other embodiments, two extension arms 214 may be used. In the transition state, the two extension arms 214 are circumferentially outward and away from the locked state. In the locked position, the action part 320 hugs the two extension arms 214 to suppress the outward deformation of the lock 213.

[0115] See Figures 16-21 Another embodiment of this application provides an expander and a corresponding medical device assembly. The expander includes a second connecting seat 210 and a rod 220 extending distally from the second connecting seat 210. A locking member 213 is located at the second connecting seat 210 and extends distally. The main difference from the previous embodiments is that the shape and deformation mode of the locking member 213 are different in this embodiment, while the retaining member 300 is adapted accordingly.

[0116] In this embodiment, the extension arm 214 has a radial inner side and an outer side, and the hook-shaped portion 215 protrudes radially inward, in contrast to Figure 19 as well as Figure 21 As can be seen, the distal end of the extension arm 214 is radially outward in the transition state. After passing through the lock hole 115, the extension arm 214 returns to its original position, that is, the hook-shaped portion 215 is offset inward and engaged with the distal end of the lock hole 115 in the locked state. The retainer 300 includes: The sliding seat 310 is annular and is slidably sleeved on the outer periphery of the second connecting seat 210; The action part 320 extends from the sliding seat 310 to the distal end and abuts against the locking member 213. The action part 320 is a strip extending axially and has a C-shaped cross section. In the locked position, the action part 320 abuts against the outer radial side of the hook-shaped part 215 and semi-encloses the locking member 213, further keeping the locking member 213 in the locked state and suppressing its radial outward roll.

[0117] In other embodiments of this application, a locking structure for a medical device assembly and a medical device assembly having the locking structure are also provided. The medical device assembly includes a first device and a second device that are plugged into each other. The first device and the second device are not strictly limited to specific types, but are generally plugged into each other for use. The locking structure of this embodiment includes: Keyhole 115 is located in the first instrument. Lock 213 is disposed on the second instrument and is inserted into the lock hole 115.

[0118] In one embodiment, the locking member 213 and the lock hole 115 can be axially inserted and engaged. In another embodiment, the locking member 213 adopts a deformable structure and has a relative transition state and a locked state. The locking member 213 is inserted through the lock hole 115 in the transition state and is located in the lock hole 115 in the locked state. The locking structure also includes a retainer 300 for retaining the locking member 213 in the locked state to prevent the locking member 213 from disengaging from the lock hole 115.

[0119] In another embodiment, the locking structure further includes a retainer 300 slidably disposed on the second instrument for retaining the lock 213 in the locked state, wherein the sliding direction of the retainer 300 is parallel to the insertion direction of the lock 213.

[0120] Of course, it can also be combined with the embodiments described above, i.e., the first device is a catheter sheath 100, and the second device is a dilator 200 delivered to a preset position via the catheter sheath 100. The catheter sheath 100 includes a first connector 110 and a sheath tube 120 extending distally from the first connector 110, with a locking hole 115 located in the first connector 110 and opening towards the proximal side. The dilator 200 includes a second connector 210 and a rod 220 extending distally from the second connector 210, with a locking member 213 located in the second connector 210 and extending distally. Other specific structural details of the medical device components can be found in the embodiments described above.

[0121] See Figures 22-26Another embodiment of this application provides an expander and a corresponding medical device assembly. The medical device assembly includes an expander and a catheter sheath for guiding the delivery of the expander. The catheter sheath includes a first connecting seat 110 and a sheath tube (omitted in the figure) extending distally from the first connecting seat 110. The expander includes a second connecting seat 210 and a rod extending distally from the second connecting seat 210 (omitted in the figure). The first connecting seat 110 is provided with a locking hole, and the second connecting seat 210 is provided with a locking member 213 for insertion into a corresponding locking hole 115. A retainer 300 is slidably mounted on the second connecting seat 210 for maintaining the locking member 213 in engagement with the locking hole 115.

[0122] Compared to Figure 14 , Figure 15 The main difference in this embodiment is that the second connecting seat 210 adopts a split structure, including a nested and fixed inner cylinder 210a and an outer cylinder 210b. The proximal end of the rod can be inserted and fixed in the inner cylinder 210a. The proximal end of the inner cylinder 210a has a radially outwardly expanding annular portion 212, and the end is provided with a Luer connector 218 for connecting the inside of the rod body. The locking member 213 is a pair of extended arms and connected to the outer cylinder 210b.

[0123] The retainer 300 is slidably sleeved on the outside of the outer cylinder 210b. Figure 23 As can be seen, the inner side of the retainer 300 is provided with a support rib 313 that slides against the outer wall of the outer cylinder 210b. The action part 320 is slidably arranged between the two extension arms. The inner side of the retainer 300 is also provided with a first positioning tooth 312. The outer wall of the outer cylinder 210b is provided with a second positioning tooth 219 that cooperates with the first positioning tooth 312. In the circumferential direction of the outer cylinder 210b, the second positioning tooth 219 and the lock 213 are alternately arranged and spaced a certain distance from each other.

[0124] Comparison Figure 25 , Figure 16 As can be seen, there are two second positioning teeth 219 corresponding to the circumferential position, and two holding positions are provided, which can hold the first positioning tooth 312 on the corresponding side respectively, so that the retainer 300 is in the locked position or the unlocked position.

[0125] See Figures 27-31 Another embodiment of this application provides a sheath 120 that can be applied to the catheter sheaths of the preceding embodiments. The sheath 120 includes a tube body and has opposing distal and proximal ends, with the proximal end of the tube body connected to a first connector.

[0126] One section of the tube is radially deformable (e.g., elastic, plastic, or destructive) and can be kept at a small, preset size to facilitate passage within the body. When other interventional devices, such as dilators, are inserted into the tube, the tube's adaptive deformation allows larger interventional devices to pass through.

[0127] The pipe body comprises, from distal to proximal, a distal section 120c, an expandable section 120b, and a proximal section 120a. At least the distal section 120c and the expandable section 120b are radially deformable. Along the axial direction of the pipe body, the distal section 120c is approximately 3-30 mm long, and the proximal section 120a can be 5-30% of the total length of the pipe body. The expandable section 120b has a multi-layered structure, specifically including: The inner layer 121, along the circumference of the pipe body, has one or more bends 1211 arranged at intervals. Figure 28 The three meandering sections 1211 are visible in the middle, arranged at intervals; The reinforcing ribs 123 are located outside the inner layer 121 and are arranged alternately with the meandering parts 1211 in the circumferential direction of the tube body. For example, three reinforcing ribs 123 and three meandering parts 1211 are distributed approximately evenly in the circumferential direction of the tube body. The outer layer 122 wraps around the inner layer 121 and the outer periphery of the reinforcing rib 123.

[0128] The inner layer 121 can be made of PTFE, while the outer layer 122 and the reinforcing rib 123 can both be made of Pebax. The reinforcing rib 123 is made of a harder material, while the outer layer 122 is relatively softer. The reinforcing rib 123 is wrapped by the inner layer 121 and the outer layer 122, and the three are fused or bonded together at the junction. After the expandable section 120b is expanded, it undergoes radial deformation and switches to an outward expansion state. In the outward expansion state, the meandering part 1211 tends to expand, and the corresponding part of the outer layer 122 adapts to deformation or cracking.

[0129] Although the inner layer 121 has a tortuous section 1211, it still maintains a smooth transition of the inner wall to reduce friction with the interventional device. The inner layer 121 can be an integral structure and locally folded to form the tortuous section 1211. Alternatively, the tortuous section 1211 can be pre-processed and assembled with other parts.

[0130] The distal end of the reinforcing rib 123 extends to the junction of the distal segment 120c and the expandable segment 120b, and the proximal end of the reinforcing rib 123 extends to the junction of the proximal segment 120a and the expandable segment 120b. The inner layer 121 and the outer layer 122 are fused together at the distal segment 120c to form a single-layer structure, or only one of the inner layer 121 and the outer layer 122 is retained at the distal segment 120c, or the distal segment 120c is a separate tube at one end. The distal segment 120c itself may be deformable or ruptured to accommodate the passage of interventional instruments.

[0131] See Figure 29 In one embodiment, the proximal ends of each reinforcing rib 123 are interconnected to form an annular junction 124. Each reinforcing rib 123 can be fabricated by integrally cutting a tube. Figure 30 , Figure 31The diagram further illustrates the distribution of three reinforcing ribs 123 and three bends 1211. The diameter of the expandable section 120b gradually increases as it approaches the proximal section 120a until it connects with the proximal section 120a. The degree of bend in the circumferential direction of the bend 1211 gradually decreases as the expandable section 120b gradually increases in diameter, which can also be understood as gradually expanding to accommodate the increase in pipe diameter.

[0132] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0133] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. A locking structure for a medical instrument assembly, the medical instrument assembly comprising a first instrument and a second instrument that are mated together, characterized by, The locking structure includes: The keyhole is located in the first instrument. A locking element is disposed on the second instrument and inserted into the keyhole. The locking element has a deformable structure and has a relative transition state and a locked state, wherein the locking element is inserted through the keyhole in the transition state and is located in the keyhole in the locked state. A retainer is provided to keep the locking member in the locked state, thereby preventing the locking member from disengaging from the keyhole.

2. The closure structure of claim 1, wherein The retainer is slidably mounted on the second instrument and the sliding direction is parallel to the insertion direction of the lock.

3. The closure structure of claim 1, wherein The medical device assembly has opposing distal and proximal ends, and an axial direction extending between the distal and proximal ends, wherein the locking hole and the locking member are axially inserted into each other.

4. The locking structure according to any one of claims 1 to 3, characterized in that, The first device is a catheter sheath, and the second device is a dilator delivered to a predetermined position via the catheter sheath; The catheter sheath includes a first connector and a sheath extending distally from the first connector, with a locking hole located at the first connector and opening towards the proximal side; The expander includes a second connector and a rod extending distally from the second connector, the locking element being located on the second connector and extending distally.

5. The closure structure of claim 4, wherein The locking element includes: An extension arm extends from the second connecting seat to the distal end; The hook-shaped portion is located at the end of the extended arm; In the transition state, the extension arm deforms and allows the hook-shaped portion to pass through the keyhole from the proximal end to the distal end. In the locked state, the hook-shaped portion is restricted by the edge of the keyhole on the distal end side of the keyhole.

6. The closure structure of claim 5, wherein The extension arm has a radial inner side and an outer side, the hook-shaped portion protrudes inward, and the distal end of the extension arm is radially outward in the transition state relative to the locked state.

7. The closure structure of claim 6, wherein The retaining member has a locked position and an unlocked position relative to the locking member; The retainer abuts against the radially outer side of the hook portion in the locked position.

8. The closure structure of claim 7, wherein The retaining element includes: The sliding seat is annular and slidably sleeved on the outer periphery of the second connecting seat; The actuating part extends from the sliding seat to the distal end, and in the locked position, the actuating part partially surrounds the extending arm.

9. The locking structure according to claim 8, characterized in that, The sheath includes a tube body, one section of which is an expandable section, the expandable section comprising: The inner layer, along the circumference of the tube, has one or more bends arranged at intervals. Reinforcing ribs are located outside the inner layer and are alternately arranged with the meandering portion in the circumferential direction of the tube body; The outer layer, which wraps around the inner layer and the outer periphery of the reinforcing rib; The expandable section has an outward expansion state with radial deformation after expansion. In the outward expansion state, the meandering part tends to unfold, and the corresponding part of the outer layer adapts to deformation or expansion and cracking.

10. A medical device component, characterized in that, It has the locking structure according to any one of claims 1 to 9.

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