CN114432568A

CN114432568A - Adjustable bent sheath

Info

Publication number: CN114432568A
Application number: CN202011199818.2A
Authority: CN
Inventors: 李阳; 彭波波; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-10-30
Filing date: 2020-10-30
Publication date: 2022-05-06
Anticipated expiration: 2040-10-30
Also published as: CN118750729A; CN114432568B

Abstract

The invention provides an adjustable bending sheath, which comprises a sheath tube assembly and a handle assembly, wherein the handle assembly comprises an inner core, a fixed seat and a driving piece, the distal end of the sheath tube assembly is provided with an adjustable bending section, the proximal end of the sheath tube assembly is fixedly connected with the inner core, the driving piece is rotatably connected with the fixed seat, one of the fixed seat and the driving piece comprises an elastic element, the other one of the fixed seat and the driving piece comprises an angle indexing part, the angle indexing part comprises a plurality of indexing elements arranged at intervals, and when the driving piece rotates relative to the fixed seat, the elastic element moves among the indexing elements. Because the near-end fixed connection inner core of sheath pipe subassembly, driving piece fixed connection inner core, consequently, the ration of driving piece is rotated the ration that drives the sheath pipe subassembly and is rotated to realize the accurate regulation and control of the bent angle of sheath pipe subassembly, avoid appearing the sheath pipe subassembly and rotate too much or rotate the not enough condition.

Description

Adjustable bent sheath

Technical Field

The invention relates to the technical field of medical instruments, in particular to an adjustable bending sheath.

Background

The interventional catheter treatment is a kind of minimally invasive treatment, and is one medical imaging equipment to introduce special catheter, guide wire and other precise instrument into human body for diagnosis and local treatment of pathological changes in body. In cardiac intervention, transcatheter mitral valve repair, transcatheter mitral valve replacement, transcatheter aortic replacement, and the like are representative. The interventional minimally invasive treatment operation through the catheter needs to be assisted by adjusting the bent sheath, so that the operation instrument is ensured to be conveyed to a required position through a bent blood vessel, and then the minimally invasive operation is carried out.

The prior art discloses an adjustable bend guide catheter that includes a catheter tip, a fixed bend section, a deflectable section, a catheter body, and a catheter handle. The catheter handle is provided with a first knob and a second knob, the first knob is used for controlling the catheter body of the catheter to rotate along the central shaft of the catheter main body, and the second knob is used for controlling the deflection of the deflectable section of the catheter. However, when the direction of the catheter body needs to be adjusted, the existing adjustable bent catheter only can directly rotate the catheter body of the guiding catheter, and the rotation amount of the whole rotation of the guiding catheter is difficult to control, so that the situations of excessive rotation or insufficient rotation are easy to occur.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide an adjustable bending sheath capable of quantitatively adjusting and controlling the bending angle of a pipe body.

In order to solve the technical problem, the invention provides an adjustable bending sheath, which comprises a sheath tube assembly and a handle assembly, wherein the handle assembly comprises an inner core, a fixed seat and a driving piece, the distal end of the sheath tube assembly is provided with an adjustable bending section, the proximal end of the sheath tube assembly is fixedly connected with the inner core, the driving piece is rotatably connected with the fixed seat, one of the fixed seat and the driving piece comprises an elastic element, the other one of the fixed seat and the driving piece comprises an angle indexing part, the angle indexing part comprises a plurality of indexing elements arranged at intervals, and when the driving piece rotates relative to the fixed seat, the elastic element moves among the indexing elements.

In the adjustable bent sheath, one of the fixed seat and the driving piece comprises the elastic element, and the other one comprises the angle indexing part, and when the driving piece rotates relative to the fixed seat, the elastic element is matched with the angle indexing part to enable the driving piece to rotate quantitatively. Because the near-end fixed connection inner core of sheath pipe subassembly, driving piece fixed connection inner core, consequently, the ration of driving piece is rotated the ration that drives the sheath pipe subassembly and is rotated to realize the accurate regulation and control of accent angle direction of sheath pipe subassembly, avoid appearing the whole too much or not enough condition of rotation of sheath pipe subassembly.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic perspective view of an adjustable curved sheath according to a first embodiment of the present invention;

FIG. 2 is an exploded perspective view of the adjustable bend sheath of FIG. 1;

FIG. 3 is an exploded isometric view of another view of the adjustable bend sheath of FIG. 1;

FIG. 4 is an exploded perspective view of the bendable sheath of FIG. 3 with the outer shell and bending member removed;

FIG. 5 is a perspective view of the sheath assembly, core, sliding member and retaining member of the adjustable sheath of FIG. 2;

FIG. 6 is an exploded perspective view of the bend adjustment assembly and pulling member of FIG. 2;

FIG. 7 is a schematic cross-sectional view of a sheath assembly of the adjustable bending sheath of the present invention;

FIG. 8 is a schematic perspective view of the fixing base and the driving member shown in FIG. 4;

FIG. 9 is an exploded perspective view of the fixing base and the driving member shown in FIG. 8;

FIG. 10 is an exploded perspective view of the driving member and another view of the fixing base of FIG. 9;

FIG. 11 is a cross-sectional view of the fixing base and the driving member shown in FIG. 8;

FIG. 12 is a further perspective assembled view of the bendable sheath of FIG. 2;

FIG. 13 is a front view of the adjustable bend sheath of FIG. 1;

FIG. 14 is a sectional view taken along line XIV-XIV in FIG. 13;

FIG. 15 is a schematic perspective view of the first embodiment of the present invention with the bendable sheath on the support platform;

FIG. 16 is an exploded perspective view of the adjustable sheath and support stage of FIG. 15;

FIG. 17 is a schematic perspective view of a fixing base and a driving member of an adjustable sheath according to a second embodiment of the present invention;

FIG. 18 is an exploded perspective view of the fixing base and the driving member shown in FIG. 17;

FIG. 19 is an exploded perspective view of the driving member and another view of the fixing base shown in FIG. 18;

FIG. 20 is a cross-sectional view of the fixing base and the driving member shown in FIG. 17;

FIG. 21 is a schematic perspective view of a fixing base and a driving member of an adjustable sheath according to a third embodiment of the present invention;

FIG. 22 is an exploded perspective view of the fixing base and the driving member shown in FIG. 21;

FIG. 23 is an exploded perspective view of the driving member and another view of the fixing base shown in FIG. 18;

FIG. 24 is an exploded perspective view of the fixing base and the driving member of the adjustable sheath according to the fourth embodiment of the present invention;

FIG. 25 is a cross-sectional view of the fixed base and the driving member of FIG. 24 shown assembled;

fig. 26 is an exploded perspective view of the fixing base and the driving member of the adjustable sheath according to the fifth embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as, for example, "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the appended drawings and are, therefore, used herein for better and clearer illustration and understanding of the invention, and do not indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the invention.

Orientation definition: for clarity of description, the end of the procedure that is closer to the operator will be referred to as the "proximal end" and the end that is further from the operator will be referred to as the "distal end". This definition is for convenience of presentation only and is not to be construed as limiting the invention, with "axial" referring to the axial direction of the sheath.

First embodiment

Referring to fig. 1 to 3, the present invention provides an adjustable bending sheath 100, which includes a sheath assembly 20 and a handle assembly 40. The handle assembly 40 includes an inner core 41, a housing 42 covering the inner core 41, a bending member 43 rotatably covering the inner core 41, a fixing seat 44 disposed at a proximal end of the inner core 41, and a driving member 45. The distal end of the sheath tube assembly 20 is provided with an adjustable bending section 21, and the proximal end of the sheath tube assembly 20 is fixedly connected with the inner core 41. The driving member 45 is fixedly connected with the inner core 41, and the driving member 45 is rotatably connected with the fixed seat 44. One of the fixed seat 44 and the driving member 45 includes an elastic member 46, and the other includes an angular indexing portion 47. The angular indexing section 47 includes a plurality of indexing elements 471 arranged at intervals. When the driving member 45 rotates relative to the fixed seat 44, the elastic member 46 moves between the plurality of index members 471.

In the bendable sheath 100 of the present invention, one of the fixed base 44 and the driving member 45 includes the elastic member 46, and the other includes the angle-dividing portion 47, and when the driving member 45 rotates relative to the fixed base 44, the elastic member 46 cooperates with the angle-dividing portion 47 to allow the driving member 45 to rotate quantitatively. Because the proximal end fixed connection inner core 41 of sheath pipe subassembly 20, driving piece 45 fixed connection inner core 41, consequently, the ration of driving piece 45 is rotated and is driven the ration rotation of sheath pipe subassembly 20 to realize the accurate regulation and control of accent bent angle direction of sheath pipe subassembly 20, avoid appearing the whole too much or the not enough condition of rotation of sheath pipe subassembly 20.

It is understood that the distal end of the sheath assembly 20 is provided with the adjustable bending section 21, and the bending adjusting part 43 is used for adjusting the bending angle of the adjustable bending section 21, so that the distal end of the sheath assembly 20 forms the adjusting angle. When the driving member 45 rotates relative to the fixing seat 44, the elastic element 46 moves between the plurality of dividing elements 471, so that the driving member 45 drives the inner core 41 to rotate, and the inner core 41 rotates to drive the sheath assembly 20 to rotate, so as to adjust the bending angle direction of the adjustable bending section 21. The proximal end of the sheath assembly 20 and the inner core 41 may be joined together by, but not limited to, glue, snap, or heat, and the sheath assembly 20 is coaxial with the inner core 41.

Referring to fig. 4-9, the sheath assembly 20 includes an inner membrane 201, an enhanced tube 202 disposed on the inner membrane 201, and an outer tube 203 disposed on the enhanced tube 202. The inner membrane 201 may be a flexible tube made of a flexible material such as Polytetrafluoroethylene (PTFE) and is susceptible to bending. The reinforcing tube 202 may be a metal braided mesh structure or a metal tube cut mesh structure, and the reinforcing tube 202 has a certain rigidity and can be bent in the axial direction, so as to provide support for the sheath assembly 20, prevent the sheath assembly 20 from being twisted and deformed in the radial direction, and simultaneously, not affect the bending of the adjustable bending section of the sheath assembly 20. The outer tube 203 is made of a material having a certain hardness, such as block polyether amide resin (PEBAX), so as to protect the sheath assembly 20. The outer tube 203 has a hardness corresponding to the bendable section 21 smaller than that of the other portion of the outer tube 203, so that the effect on the bending of the bendable section 21 is avoided while the protection of the sheath assembly 20 is achieved. The inner membrane 201, the reinforcing tube 202 and the outer tube 203 are formed together by hot melt composite molding to form at least one delivery lumen 205 extending completely through from the proximal end to the distal end along the axial center line of the sheath assembly 20. The end of the sheath assembly 20 is a smooth guiding head 23, i.e. Tip head, and a developing ring (not shown) is disposed adjacent to the end of the Tip head, the developing ring includes but is not limited to a tantalum ring, etc., so that whether the distal end of the sheath assembly 20 reaches a specified position can be accurately known under the developing device.

As shown in fig. 5 and 6, the sheath assembly 20 further includes a pulling member 25 connected to the adjustable bending section 21. The retractor 25 includes a retractor wire 251 and an anchoring ring 253 disposed at a distal end of the retractor wire 251. Anchor ring 253 is connected to adjustable bend section 21, preferably with anchor ring 253 coaxial with adjustable bend section 21. Specifically, anchor ring 253 may be heat fused with adjustable bend section 21. The distal ends of the wires 251 are attached to the anchoring ring 253 by means including, but not limited to, gluing, welding, heat staking or knotting. The wall of the sheath tube assembly 20 is axially provided with a filament cavity, and the traction wire 251 is movably accommodated in the filament cavity of the sheath tube assembly 20. Specifically, the filament lumen may open into the wall of the stiffening tube 202 or the outer tube 203 of the sheath assembly 20, i.e., the filament lumen is embedded in the wall of the stiffening tube 202 or the outer tube 203. The pulling wire 251 is used for pulling the adjustable bending section 21 to bend or straightening the adjustable bending section 21 after the pulling force on the pulling wire 251 is released. The traction wire 251 may be made of a metal material, such as stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy, or may be made of a polymer material with certain strength. The proximal end of the pull wire 251 may be connected to the bend adjustment member 43, such that the pull wire 251 pulls the adjustable bend section 21 to bend or straighten by operating the bend adjustment member 43.

As shown in fig. 4 and 5, the inner core 41 includes a positioning portion 411 disposed at the distal end, a connecting portion 415 disposed at the proximal end, and a slide guide portion 417 disposed between the positioning portion 411 and the connecting portion 415. Specifically, the positioning portion 411 includes a distal core tube 4110, a first positioning ring 4112 fixed on the distal end of the distal core tube 4110, and a second positioning ring 4114 fixed on the proximal end of the distal core tube 4110. The periphery wall of first holding ring 4112 is provided with at least one ring of draw-in groove 4115 along circumference, and one side of second holding ring 4114 facing first holding ring 4112 is provided with at least one holding groove 4116 along circumference. The outer peripheral wall of the distal core tube 4110 is axially provided with a through groove 4117, and the second positioning ring 4114 is radially provided with a notch 4118 communicating with the through groove 4117. The slide guide portion 417 includes a slide guide tube 4171 fixedly connected to the proximal end of the distal core tube 4110, and a stopper 4173 disposed at the proximal end of the slide guide tube 4171, an inner cavity of the slide guide tube 4171 communicates with an inner cavity of the distal core tube 4110, and a guide groove 4175 communicating with the through groove 4117 is axially disposed on an outer peripheral wall of the slide guide tube 4171. The connecting portion 415 includes a proximal core tube 4150 connected to a side of the stop piece 4173 facing away from the slide guide tube 4171 and a plurality of engaging members 4153 disposed at a proximal end of the proximal core tube 4150. The lumen of the proximal barrel 4150 is in axial communication with the lumen of the sliding guide tube 4170. The plurality of engaging members 4153 are arranged in a circle along the circumference of the proximal core tube 4150. The proximal end of the inner core 41 is further provided with a plurality of outer engaging grooves 4155, specifically, the outer circumferential wall of the proximal core tube 4150 is provided with a plurality of engaging grooves 4155 along the axial direction, and the plurality of engaging grooves 4155 are arranged in a circle along the circumferential direction of the proximal core tube 4150.

As shown in fig. 2-6, the bending adjustment member 43 includes a sliding member 430 and a bending adjustment member 437 sleeved on the sliding member 430. The proximal end of the pull wire 251 is fixedly connected to the sliding member 430, and the sliding member 430 is axially slidably sleeved on the sliding guide portion 417 of the inner core 41. The sliding element 430 is in threaded fit with the bend-adjusting element 437, and the bend-adjusting element 437 is rotated to drive the sliding element 430 to move along the axial direction of the inner core 41, so as to drive the pull wire 251 to pull the bend-adjustable section 21 to bend or restore to be straight.

Specifically, the sliding member 430 includes a sliding block 431 sleeved on the sliding guide portion 417, a connecting rod 432 disposed at a distal end of the sliding block 431, an identification member 434 disposed at a distal end of the connecting rod 432, and a pull wire fixing block 435 connected to the sliding block 431. The slide block 431 is provided with a notch 4310 along the axial direction, and the slide guide portion 41 is accommodated in the notch 4310. The pull wire fixing block 435 is disposed on an inner wall of the notch 4310 and extends radially to the notch 4310, and the pull wire fixing block 435 is used for fixedly connecting a proximal end of the pull wire 251. It will be appreciated that the distal end of the pull wire fixing block 435 is axially provided with a fixing hole, and the proximal end of the pull wire 251 is fixedly coupled in the fixing hole. The traction wire fixing block 435 and the sliding block 431 can be fixedly connected in a clamping, screwing or gluing mode or can be integrally formed. The sliding block 431 is provided with an external thread 4312, the bending adjusting piece 437 is axially provided with an inner cavity penetrating through the proximal end surface and the distal end surface of the bending adjusting piece 437, and the inner peripheral wall of the inner cavity of the bending adjusting piece 437 is provided with an internal thread 4371 matched with the external thread 4312. The marker 434 may be composed of two detachable semicircular rings, one of which is fixedly connected to the distal end of the connecting rod 432 of the slider 431, for easy installation.

The housing 42 is composed of two frame bodies 420 detachably engaged with each other, an observation window 421 is axially disposed on an outer peripheral wall of at least one of the frame bodies 420, an indication scale 423 is disposed on at least one side of the observation window 421 of one of the frame bodies 420, and the indication scale 423 is used for indicating a position of the identification member 434, so as to measure a length of the sliding member 430 sliding along the axial direction. Specifically, the scale indicating the position of the scale 423 corresponding to the marking 434 is confirmed by observing the window 421, and the corresponding bending angle of the adjustable bending section 21 can be obtained by reading the scale. The intersection of the peripheral walls of the two frames 420 is provided with a positioning recess 425.

Referring to fig. 8-11, the fixing base 44 includes a connection ring 441, and the connection ring 441 includes a connection hole 442 axially penetrating through the fixing base 44. The driving member 45 includes a connecting barrel 451, and the connecting barrel 451 is rotatably disposed through the connecting hole 442. Thus, the driving member 45 is rotatably connected to the fixing base 44. In this embodiment, the fixing base 44 further includes a fixing ring 445 disposed at one end of the connection ring 441. The fixing ring 445 is coaxial with the connecting ring 441, the inner cavity of the fixing ring 445 is communicated with the inner cavity of the connecting ring 441, the inner diameter of the fixing ring 445 is larger than that of the connecting ring 441, and the outer diameter of the fixing ring 445 is larger than that of the connecting ring 441, so that the fixing seat 44 is in a circular step structure, namely a step 446 is formed in the position, close to the connecting ring 441, of the inner cavity of the fixing ring 445. The outer peripheral wall of the fixing ring 445 is provided with two symmetrical fixing surfaces 447, each fixing surface 447 extending in the axial direction of the fixing ring 445. The outer peripheral wall of the connection ring 441 is provided with at least two spaced mounting holes 448, each mounting hole 448 extending in a radial direction of the connection ring 441. Preferably, the outer peripheral wall of the connection ring 441 is provided with at least two symmetrical mounting holes 448. The elastic member 46 is provided at the outer circumferential wall of the connection ring 441, and in this embodiment, the elastic member 46 is mounted in the mounting hole 448. Specifically, the resilient member 46 may be a plunger spring screw, and the mounting holes 448 are used to mount the plunger spring screw. The plunger elastic screw comprises a shell 462, a spring and a steel ball 465, wherein the spring is positioned in the shell 462 and is connected with the steel ball 465, and the steel ball 465 can be pushed to move by the elasticity of the spring.

The drive member 45 further includes a drive cylinder 453 coaxial with the connection cylinder 451, the connection cylinder 451 being received in the drive cylinder 453. The end of the connecting cylinder 451 is integrally connected to the driving cylinder 453 through a connecting plate, an annular groove 454 is formed between the driving cylinder 453 and the connecting cylinder 451, and the connecting ring 441 is rotatably received in the annular groove 454. Specifically, the end of the outer peripheral wall of the connecting cylinder 451, which is far away from the connecting plate, is provided with a clamping groove 4512 along the circumferential direction. The inner circumferential wall of the connecting cylinder 451 is provided with a plurality of clamping ridges 4514 along the axial direction, and the plurality of clamping ridges 4514 are arranged along the circumferential direction of the connecting cylinder 451. The plurality of index members 471 are provided on the inner circumferential wall of the drive cylinder 453, and the plurality of index members 471 may be provided at equal intervals or may be provided at unequal intervals. In this embodiment, the indexing elements 471 are grooves arranged at intervals on the inner circumferential wall of the driving cylinder 453, and when the driving member 45 rotates relative to the fixing seat 44, the elastic elements 46, i.e. plunger elastic screws, are sequentially inserted into the grooves. The plurality of grooves may be arranged uniformly one turn in the circumferential direction of the drive cylinder 453, that is, the plurality of grooves may be arranged at equal intervals in the circumferential direction of the drive cylinder 453. Each groove can be matched with the elastic element 46, in the embodiment, each groove is matched with the steel ball 465, namely, the steel ball 465 can be clamped in the groove or separated from the clamping connection with the groove. If the number of the index members 471 provided on the inner circumferential wall of the drive cylinder 453 is N, the angle between each adjacent two index members 471 is 360 divided by N. The peripheral wall of the driving cylinder 453 is provided with an angle indicator along the circumferential direction thereof, and in this embodiment, the peripheral wall of the driving cylinder 453 is provided with 0 degree, 90 degrees, 180 degrees, 270 degrees and the like for the user to determine the rotation angle of the driving member 45 relative to the fixing base 44.

When assembling the fixing seat 44 and the driving member 45, the elastic element 46 is first snapped into the corresponding mounting hole 448, and since the elastic element 46 is in interference fit with the mounting hole 448, it is ensured that the elastic element 46 does not get out of the mounting hole 448. Then, the connection ring 441 of the fixing base 44 is rotatably received in the annular groove 454, and the connection cylinder 451 is inserted through the connection hole 442 and exposed out of the slot 4512. Specifically, the end of the connecting tube 451 is received in the inner cavity of the fixing ring 445, and the engaging groove 4512 is exposed from the step 446. The snap spring 48 of the handle assembly 40 is then snapped into the snap groove 4512 to provide a locking connection between the fixed seat 44 and the driving member 45. At this time, the fixing seat 44 and the driving member 45 can rotate relatively, that is, after the fixing seat 44 is fixed, the driving member 45 can rotate bidirectionally relative to the fixing seat 44, but the fixing seat 44 and the driving member 45 cannot move relatively in the axial direction, that is, the fixing seat 44 and the driving member 45 cannot move separately in the axial direction. When the driving member 45 rotates relative to the fixed seat 44, the steel balls 465 of the elastic element 46 are sequentially clamped into the grooves; when the driving member 45 does not rotate relative to the fixing seat 44, the steel balls 465 of the elastic element 46 are embedded into the corresponding grooves of the driving member 45 to realize position self-locking, that is, the fixing seat 44 and the driving member 45 are kept relatively positioned under the action of no external force, so as to always protect the bending direction of the adjustable bending section 21 of the sheath tube assembly 20.

In other embodiments, the elastic member 46 may be provided on the inner circumferential wall of the driving cylinder 453, and the plurality of index members 471 may be provided on the outer circumferential wall of the coupling ring 441. Specifically, the inner circumferential wall of the driving cylinder 453 is provided with at least two spaced mounting holes, each mounting hole is provided with an elastic element 46 therein, and the elastic elements 46 are plunger elastic screws. The peripheral wall of the connection ring 441 is provided with a plurality of index members 471 along the circumferential direction thereof, and the plurality of index members 471 are a plurality of grooves arranged at intervals.

In other embodiments, the resilient member 46 is a resilient protrusion, which may be provided on the outer circumferential wall of the connection ring 441 or the inner circumferential wall of the driving cylinder 453. The plurality of indexing elements 471 are a plurality of grooves. Specifically, when two or more spaced elastic protrusions are provided at the outer circumferential wall of the connection ring 441, a plurality of grooves are provided at the inner circumferential wall of the driving cylinder 453 and are arranged one turn in the circumferential direction of the driving cylinder 453. When two or more elastic protrusions are provided at the inner circumferential wall of the driving cylinder 453, a plurality of grooves are provided at the outer circumferential wall of the coupling ring 441 and are arranged one turn along the circumference of the coupling ring 441. When the driving member 45 rotates relative to the fixing seat 44, the elastic protrusions are sequentially clamped into the plurality of grooves. When the driving member 45 does not rotate relative to the fixing seat 44, the elastic protrusions are embedded into the corresponding grooves, so that position self-locking is realized.

Referring to fig. 2 to 5, the handle assembly 40 further includes a fixing member 491, a sealing nut 492, a sealing silicone rubber 494 and a sealing silicone rubber support member 496. The fixing member 491 is provided with a clip interface 4915, the proximal end of the inner core 41 penetrates through the connecting barrel 451 and exposes a plurality of clip members 4153, and the plurality of clip members 4153 are inserted into the clip interface 4915. Specifically, the fixing member 491 includes a fixing tube 4911 and an annular clamping piece 4913 fixedly sleeved on the fixing tube 4911, wherein an external thread is disposed at one end of the outer peripheral wall of the fixing tube 4911, and a clamping opening 4915 is disposed at one end of the fixing tube 4911 away from the external thread. The sealing nut 492 is provided with an internal thread to be fitted with the fixed cylinder 4911. The sealing silicone 494 is mounted on the fixing member 491 via a sealing silicone support member 496. The inner cavity of the adjustable bent sheath 100 is used for accommodating and passing through a conveying sheath of an interventional medical device, and the sealing nut 492 and the sealing silica gel 494 can be wrapped on the periphery of the conveying sheath to seal the conveying sheath, so that blood leakage is avoided in the operation process.

Referring to fig. 1-6 and 12-14, when assembling the adjustable bending sheath 100, the sliding member 430 is first mounted on the inner core 41. Specifically, the sliding block 431 is sleeved on the sliding guide portion 417, the pull wire fixing block 435 is accommodated in the guide groove 4175, the proximal end of the pull wire 251 is fixedly connected to the pull wire fixing block 435, the connecting rod 432 is inserted into the notch 4118 of the second positioning ring 4114, and the identification member 434 is fastened on the positioning portion 411. The sliding block 431 can slide along the axial direction of the inner core 41 to drive the identification member 434 to slide axially, and the sliding block 431 is stopped between the second positioning ring 4114 and the blocking piece 4173. Next, the two frame bodies 420 are fastened to the positioning portion 411 of the inner core 41, so that the distal end wall of each frame body 420 is clamped into the clamping groove 4115 of the first positioning ring 4112, and the proximal end wall of each frame body 420 is clamped into the positioning groove 4116 of the second positioning ring 4114. Thirdly, the bending adjusting member 437 and the slider 431 are disposed on the inner core 41 in a threaded fit, the snap spring 4370 is clamped at the proximal end of the blocking piece 4173 of the inner core 41, so that the bending adjusting member 437 is stopped between the second positioning ring 4114 and the snap spring to limit the movement of the bending adjusting member 437 in the axial direction, i.e., the bending adjusting member 437 can only rotate around the axis of the inner core 41. Then, the fixing base 44 and the driving member 45, which are integrally mounted, are mounted to the proximal end of the inner core 41, so that the proximal end of the inner core 41 is inserted and fixedly connected into the connecting cylinder 451. Specifically, the connecting portion 415 is inserted into the inner cavity of the connecting tube 451 through the inner cavity of the fixing base 44, the plurality of clamping ribs 4514 are respectively clamped in the plurality of clamping grooves 4155 of the proximal core tube 4150, and the plurality of clamping ribs 4514 are correspondingly clamped with the plurality of clamping grooves 4155 one to one. Finally, the fixing member 491 is mounted to the proximal end of the inner core 41, specifically, the plurality of clamping members 4153 of the proximal end of the inner core 41 are inserted into the clamping interface 4915 of the fixed barrel 4911 and clamped to the inner peripheral wall of the fixed barrel 4911 to lock the driving member 45 with the inner core 41; the sealing silicone 495 is mounted on the proximal end of the fixing member 491 via a sealing silicone support member 496, and a sealing nut 492 is screwed to the fixing member 491.

As shown in fig. 15 and 16, the bending adjusting part 43 is used for adjusting the bending angle of the adjustable bending section 21 of the sheath assembly 20, so as to form an adjusting angle at the distal end of the sheath assembly 20, and the cooperation between the fixing seat 44 and the driving part 45 is used for adjusting the bending angle direction of the adjustable bending section 21. When the adjustable sheath 100 is used, the housing 42 and the fixing base 44 need to be held by the support table 300 or an operator. The support table 300 includes a support 301, a bracket 305 slidably disposed on the support 301, and a retaining member 309 for positioning the bracket 305 on the support 301. The bracket 301 includes a support bar 302 extending obliquely, and the support bar 302 is provided with a guide groove 303 along the length direction thereof. The bracket 305 includes a sliding bar 306 slidably received in the guiding groove 303, and a first positioning fork 307 and a second positioning fork 308 spaced apart from each other on the sliding bar 306, wherein the first positioning fork 307 and the second positioning fork 308 are used for fixing the housing 42 and the fixing base 44, respectively. Retaining member 309 extends through support bar 302 and abuts against slide bar 306 in channel 303 to retain bracket 305. The housing 42 and the fixing base 44 are fixed on the bracket 305, specifically, the first positioning fork 307 is clamped in the positioning recess 425 of the housing 42, and the second positioning fork 308 is clamped in the fixing surface 447 of the fixing base 44.

In the interventional therapy operation, the fixing base 44 and the housing 42 are fixed by the bracket 305 so that the interface of the indication scale 423 of the housing 42 is always upward for convenient operation. When the sheath tube assembly 20 enters the body, if the bending angle adjusting direction of the adjustable bending section 21 needs to be adjusted, the inner core 41 can be driven to rotate by rotating the driving piece 45, the rotating direction of the driving piece 45 can be clockwise or anticlockwise, and can rotate according to actual needs, so that the bending angle adjusting direction of the adjustable bending section 21 is adjusted.

During the rotation of the driving member 45, the elastic member 46 moves between the plurality of index members 471 to adjust the rotation angle of the inner core 41, so that the bending angle direction of the bending section 21 can be adjusted. By providing a plurality of index members 471 at equal intervals on the inner peripheral wall of the driving member 45, the direction of the sheath assembly 20 can be controlled with equal indexing, and the magnitude of the rotating force can be controlled by the elastic deformation of the elastic member 46. Therefore, in the process of using the bendable sheath 100, the whole handle assembly 40 does not need to be rotated, the bendable piece 437 and/or the driving piece 45 can be independently rotated, so that the shell 42 and the fixing seat 44 are static in situ, the use is convenient, the operation is convenient, the rotating amount of the whole rotation of the sheath tube assembly 20 can be accurately controlled, the condition of too much rotation or insufficient rotation is avoided, the success rate of the operation is improved, and the risk of the operation is reduced.

Of course, when the adjustable sheath 100 is used, the support table 300 may not be used, and the operator may directly hold the housing 42 and/or the fixing base 44.

Second embodiment

Referring to fig. 17 to 20, the structure of the second embodiment of the adjustable sheath according to the present invention is similar to that of the first embodiment, except that: the structure of the fixing seat 44a and the driving member 45a in the second embodiment is slightly different from the structure of the fixing seat 44 and the driving member 45 in the first embodiment, and the specific structure is as follows:

in the second embodiment, the connection ring 441 includes a first side wall 4410 facing the driving member 45a, and a middle portion of the first side wall 4410 is provided with a connection hole 442 penetrating the fixing seat 44a in an axial direction. The driving member 45a includes a driving portion 453a connected to the connecting cylinder 451, the driving portion 453a is provided with a second sidewall 4531 facing the first sidewall 4410 around the connecting cylinder 451, the elastic member 46 is provided on the first sidewall 4410, and the plurality of index members 471 are provided on the second sidewall 4531. Specifically, the fixed seat 44a has a circular cylindrical structure, and the first side wall 4410 of the fixed seat 44a is provided with at least two spaced mounting holes 448, and each mounting hole 448 extends along the axial direction of the connection ring 441. Preferably, the first sidewall 4410 is provided with at least two symmetrical mounting holes 448. In this embodiment, the elastic member 46 is mounted in the mounting hole 448, and specifically, the elastic member 46 is a plunger elastic screw. The mounting holes 448 are used to mount plunger spring screws. The first side wall 4410 of the fixing seat 44a is further provided with an annular groove 4413, and the annular groove 4413 is formed for avoiding materials, reducing the wall thickness and facilitating mold opening processing. Of course, the fixing seat 44a may not be provided with the circular groove 4413. The connecting tube 451 is protruded from the middle portion of the second side wall 4531 of the driving portion 453a, and an inner cavity of the connecting tube 451 communicates with an inner cavity of the driving portion 453 a. The plurality of index members 471 are disposed on the second side wall 4531 in the circumferential direction of the connecting cylinder 451, and the plurality of index members 471 may be disposed at equal intervals or may be disposed at unequal intervals. In this embodiment, the indexing elements 471 are a plurality of grooves arranged at intervals on the second side wall 4531, and when the driving member 45a rotates relative to the fixing seat 44a, the elastic elements 46, i.e. the plunger elastic screws, are sequentially snapped into the plurality of grooves. The plurality of grooves may be arranged uniformly in a circle in the circumferential direction of the connector barrel 451, i.e., the plurality of grooves may be provided at equal intervals in the circumferential direction of the connector barrel 451. Each groove can be matched with the elastic element 46, in the embodiment, each groove is matched with the steel ball 465 of the elastic element 46, namely the steel ball 465 can be clamped in the groove or separated from the clamping with the groove. The using method and the beneficial effects of the second embodiment are the same as those of the first embodiment, and are not described again here.

In other embodiments, the resilient member 46 is provided on the second side wall 4531 of the drive cylinder 453a and the plurality of indexing members 471 are provided on the first side wall 4410 of the coupling ring 441. Specifically, at least two spaced mounting holes are formed in the second side wall 4531 along the circumferential direction of the connecting cylinder 451, each mounting hole having a resilient member 46 disposed therein, the resilient member 46 being a plunger spring screw. The first sidewall 4410 is provided with a plurality of index members along a circumferential direction thereof, and the plurality of index members are a plurality of grooves arranged at intervals.

In other embodiments, the resilient member 46 is a resilient protrusion that may be provided on the first sidewall 4410 of the attachment ring 441 or the second sidewall 4531 of the drive barrel 453 a. The plurality of indexing elements 471 is a plurality of grooves. Specifically, when two or more spaced elastic protrusions are provided on the first sidewall 4410, a plurality of grooves are provided on the second sidewall 4531 and arranged in a circle along the circumferential direction of the connecting cylinder 451. When two or more spaced elastic protrusions are disposed on the second sidewall 4531, a plurality of grooves are disposed on the first sidewall 4410 and arranged in a circle along the circumference of the connection ring 441. When the driving member 45a rotates relative to the fixing seat 44a, the elastic protrusions are sequentially clamped into the plurality of grooves. When the driving member 45a does not rotate relative to the fixing seat 44a, the elastic protrusions are embedded into the corresponding grooves, so that position self-locking is realized.

Third embodiment

Referring to fig. 21 to 23, the structure of the third embodiment of the adjustable sheath according to the present invention is similar to that of the first embodiment, except that: the structures of the fixing seat 44b and the driving member 45b in the third embodiment are slightly different from the structures of the fixing seat 44 and the driving member 45 in the first embodiment, and the specific structures are as follows:

in the third embodiment, the elastic element 46a is a rib having elasticity, and the index elements 471a of the angle index 47a are grooves arranged at intervals. When the driving member 45b rotates relative to the fixed seat 44b, the elastic ribs are sequentially engaged in the plurality of grooves. When the driving member 45b does not rotate relative to the fixing seat 44b, the elastic ribs are inserted into the corresponding grooves. Specifically, the outer peripheral wall of the connection ring 441 of the fixed seat 44b is provided with a plurality of elastically deformable elastic members 46a along the circumferential direction of the connection ring 441. The resilient member 46a is an inclined rib which is flexible and which is resiliently deformable when compressed. Each of the elastic members 46a includes a connecting piece 467 protruded from the outer circumferential wall of the connecting ring 441 and an elastic positioning bar 468 extending obliquely to one side from an end of the connecting piece 467. The resilient positioning bar 468 is inclined at an angle in the range of 0 to 90 degrees with respect to the corresponding connecting block 467. Preferably, the resilient positioning bar 468 is inclined at an angle of about 30 degrees with respect to the corresponding connecting block 467. In this embodiment, the plurality of elastic members 46a are arranged in a circle at regular intervals in the circumferential direction of the connection ring 441 on the outer circumferential wall of the connection ring 441, i.e., the plurality of elastic positioning bars 468 are arranged in a circle at regular intervals in the circumferential direction of the connection ring 441. An annular groove 454 is formed between the driving barrel 453 and the connecting barrel 451, and the index member 471a is a groove provided at an inner peripheral wall surface of the driving barrel 453 facing the annular groove 454. In the present embodiment, the inner circumferential wall of the driving cylinder 453 is provided with a plurality of grooves, the plurality of grooves are arranged in a circle along the circumferential direction of the driving cylinder 453, and the plurality of grooves can be matched with the ribs.

When assembling the fixing seat 44b and the driving member 45b, the connecting tube 451 of the driving member 45b is rotatably received in the connecting hole 442 of the fixing seat 44b and exposed out of the engaging groove 4512, and the connecting ring 441 is received in the annular groove 454, so that the convex rib of the fixing seat 44b matches with the groove of the driving member 45 b. The snap spring 48 of the handle assembly 40 is then snapped into the snap groove 4512 to lockingly engage the fixed seat 44b with the driving member 45 b. At this time, the driving member 45b can rotate in one direction relative to the fixed seat 44b, but the fixed seat 44b and the driving member 45b cannot move relatively in the axial direction. The fixing seat 44b, the driving member 45b and the inner core 41 are mounted in the same manner as the first embodiment, and are not described herein again.

The method of use and the beneficial effects of the third embodiment of the adjustable bending sheath are similar to those of the first embodiment, except that: when the fixing seat 44b is held by the bracket 305 or an operator, the driving member 45b rotates in one direction relative to the fixing seat 44b, that is, the driving member 45b rotates along the direction of the inclination angle of the protruding rib, and the elastic positioning strips 468 are sequentially clamped into the corresponding plurality of grooves. When the rotation of the driving member 45b is not required, the elastic positioning bar 468 is inserted into the groove to achieve self-locking of the position. For example, when the surgical instrument is rotated to a certain position, the elastic positioning strips 468 are respectively clamped into the grooves, so that a position self-locking function is realized, and the surgical instrument is beneficial to smooth operation.

The holder 44b can be fixed by the bracket 305 during the interventional procedure. When the sheath assembly 20 enters the body and the bending angle direction of the adjustable bending section 21 needs to be adjusted, the inner core 41 can be driven to rotate along the inclination direction of the convex rib of the fixing seat 44b by rotating the driving member 45b, so that the bending angle direction of the adjustable bending section 21 is adjusted. Due to the uniformly distributed rib structures on the fixing seat 44b, the bending angle direction of the sheath tube assembly 20 can be accurately and equivalently controlled.

In other embodiments, the number of the ribs formed on the outer circumferential wall of the coupling ring 441 may be two or more, and the number of the grooves formed on the inner circumferential wall of the driving cylinder 453 may be plural, and the plural grooves may be arranged at uniform or non-uniform intervals in the circumferential direction of the driving cylinder 453.

In other embodiments, the angular indexing portion may be a toothed ring that is disposed around the inner circumferential wall of drive cylinder 453. The toothed ring comprises a plurality of toothed grooves, the indexing element is a toothed groove, and the plurality of toothed grooves can be matched with the convex edges.

Fourth embodiment

Referring to fig. 24 and 25, the structure of the fourth embodiment of the adjustable sheath according to the present invention is similar to the third embodiment, except that: the structures of the fixing seat 44c and the driving member 45c in the fourth embodiment are slightly different from the structures of the fixing seat 44b and the driving member 45b in the third embodiment, and the specific structures are as follows:

in the fourth embodiment, the fixing seat 44c includes a first side wall 4410 facing the driving member 45c, and a plurality of elastic members 46a are provided around the connection hole 442 on the first side wall 4410, and the plurality of elastic members 46a are provided in a circle around the connection hole 442. Preferably, the plurality of elastic members 46a are uniformly spaced. Each resilient member 46a is an inclined rib which is flexible and which is resiliently deformable when compressed. Each of the elastic members 46a includes a connecting piece 467 protruded from the first side wall 4410 and an elastic positioning bar 468 extending obliquely from an end of the connecting piece 467 to one side. The angle of inclination of the resilient positioning bar 468 with respect to the corresponding link block 467 is in the range of 0 to 90 degrees; preferably, the connecting block 467 corresponding to the elastic positioning bar 468 has an inclination angle of about 30 degrees. The angular indexing portion 47b is a toothed ring provided between the drive cylinder 453 and the connecting cylinder 451, and the toothed ring is circumferentially arranged around the connecting cylinder 451. The toothed ring comprises a plurality of toothed grooves, the graduation elements 471b being toothed grooves, which all can be matched with the ribs. Preferably, the plurality of tooth-shaped grooves are arranged at regular intervals in the circumferential direction of the tooth-shaped ring. The using method and the beneficial effects of the fourth embodiment are the same as those of the third embodiment, and are not described again here.

In other embodiments, the plurality of indexing elements may be a plurality of grooves spaced apart from the second sidewall 4531 of the driving portion 453a and cooperating with a plurality of ribs provided on the first sidewall 4410 of the connection ring 441.

Fifth embodiment

Referring to fig. 26, the structure of the fifth embodiment of the adjustable sheath according to the present invention is similar to that of the fourth embodiment, except that: the structures of the fixing seat 44d and the driving member 45d in the fifth embodiment are slightly different from the structures of the fixing seat 44c and the driving member 45c in the fourth embodiment, and the specific structures are as follows:

in the fifth embodiment, a plurality of index elements 471a are disposed on the side surface of the fixing ring 445 of the fixing seat 44d facing the driving member 45d and around the connecting hole 442, and the index elements 471a are a plurality of grooves arranged at intervals. The plurality of grooves may be arranged at uniform intervals or non-uniform intervals. A plurality of elastic elements 46a are arranged on the connecting plate between the end part of the connecting cylinder 451 of the driving part 45d and the driving cylinder 453, the plurality of elastic elements 46a are arranged in a circle along the circumferential direction of the connecting cylinder 451, and each elastic element 46a is a flexible rib; the plurality of ribs mate with the plurality of grooves.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that various modifications and adaptations can be made by those skilled in the art without departing from the principle of the embodiments of the present invention, and are intended to be within the scope of the present invention.

Claims

1. The utility model provides an adjustable bending sheath, its characterized in that includes sheath pipe subassembly and handle assembly, handle assembly includes inner core, fixing base and driving piece, the distal end of sheath pipe subassembly is equipped with adjustable bending section, the near-end fixed connection of sheath pipe subassembly the inner core, driving piece fixed connection the inner core, the driving piece rotates to be connected the fixing base, the fixing base with one of them of driving piece includes elastic element, and another includes angle graduation portion, angle graduation portion includes a plurality of indexing element that the interval set up the driving piece is relative when the fixing base rotates, elastic element is in remove between a plurality of indexing element.

2. The adjustable bend sheath of claim 1, wherein the plurality of indexing elements are equally or unequally spaced.

3. The adjustable sheath of claim 1, wherein the fixing base includes a coupling ring, the coupling ring includes a coupling hole extending axially through the fixing base, and the driving member includes a coupling cylinder rotatably disposed in the coupling hole.

4. The adjustable curved sheath of claim 3, wherein the driving member includes a driving cylinder coaxial with the connecting cylinder, an annular groove is formed between the driving cylinder and the connecting cylinder, the connecting ring is rotatably received in the annular groove, the elastic member is disposed on an outer peripheral wall of the connecting ring, and the plurality of indexing members are disposed on an inner peripheral wall of the driving cylinder; or

The elastic element is arranged on the inner peripheral wall of the driving cylinder, and the indexing elements are arranged on the outer peripheral wall of the connecting ring.

5. The adjustable sheath of claim 4, wherein the resilient element is a plunger resilient screw or a resilient protrusion, the indexing elements are spaced apart recesses, and the plunger resilient screw or the resilient protrusion is sequentially engaged with the recesses when the driving member rotates relative to the fixing base.

6. The adjustable sheath of claim 5, wherein the outer circumferential wall of the connection ring or the inner circumferential wall of the driving cylinder is provided with a mounting hole along a radial direction, and the elastic member is a plunger elastic screw provided in the mounting hole.

7. The adjustable sheath of claim 4, wherein the resilient member is a rib, and the indexing members are spaced apart grooves or slots, and the rib is sequentially engaged with the grooves or slots when the driving member rotates relative to the holder.

8. The adjustable sheath of claim 3, wherein the coupling ring includes a first side wall facing the driving member, the driving member includes a driving portion coupled to the connector barrel, the driving portion is provided with a second side wall facing the first side wall around the connector barrel, the resilient member is provided on the first side wall, and the plurality of indexing members are provided on the second side wall; or,

the elastic element is arranged on the second side wall, and the indexing elements are arranged on the first side wall.

9. The adjustable sheath of claim 8, wherein the resilient element is a plunger resilient screw or a resilient protrusion, the indexing elements are spaced apart recesses, and the plunger resilient screw or the resilient protrusion is sequentially engaged with the recesses when the driving member rotates relative to the fixing base.

10. The adjustable sheath of claim 9, wherein the first sidewall or the second sidewall has a mounting hole formed therein along the axial direction, and the elastic member is a plunger elastic screw disposed in the mounting hole.

11. The adjustable sheath of claim 8, wherein the resilient member is a rib, and the indexing members are spaced apart grooves or slots, and the rib is sequentially engaged with the grooves or slots when the driving member rotates relative to the holder.

12. The adjustable sheath of claim 3, wherein the handle assembly further comprises a clamp spring, the outer peripheral wall of the connecting cylinder is provided with a clamping groove, the connecting cylinder penetrates through the connecting hole and is exposed out of the clamping groove, and the clamp spring is clamped in the clamping groove.

13. The adjustable bend sheath of claim 3, wherein the proximal end of the inner core is threaded and fixedly attached to the connector barrel.

14. The adjustable sheath of claim 13, wherein the handle assembly further comprises a fixing member, the proximal end of the inner core is provided with a plurality of engaging members, the fixing member is provided with an engaging opening, the proximal end of the inner core penetrates through the connecting cylinder and exposes the engaging members, and the engaging members are inserted into the engaging opening.

15. The adjustable curved sheath according to claim 13, wherein the proximal end of the inner core is further provided with a plurality of clamping grooves, the inner circumferential wall of the connecting cylinder is provided with a plurality of clamping ridges, and the clamping ridges and the clamping grooves are clamped in a one-to-one correspondence manner.