CN114432568B - Adjustable curved sheath - Google Patents

Abstract

The present invention provides an adjustable bending sheath, including a sheath tube assembly and a handle assembly, the handle assembly including an inner core, a fixed seat and a driving member, 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 to the inner core, the driving member is fixedly connected to the inner core, the driving member is rotatably connected to the fixed seat, one of the fixed seat and the driving member includes an elastic element, and the other includes an angle dividing portion, the angle dividing portion includes a plurality of dividing elements arranged at intervals, and when the driving member rotates relative to the fixed seat, the elastic element moves between the plurality of dividing elements. Since the proximal end of the sheath tube assembly is fixedly connected to the inner core and the driving member is fixedly connected to the inner core, the quantitative rotation of the driving member drives the quantitative rotation of the sheath tube assembly to achieve precise control of the bending angle of the sheath tube assembly, and avoid excessive or insufficient rotation of the sheath tube assembly.

Description

Adjustable curved sheath

Technical Field

The present invention relates to the technical field of medical devices, and in particular to an adjustable curved sheath.

Background Art

Transcatheter interventional therapy is a minimally invasive treatment, that is, under the guidance of medical imaging equipment, special catheters, guidewires and other precision instruments are introduced into the human body to diagnose and locally treat lesions in the body. In cardiac interventional therapy, the more representative ones are transcatheter mitral valve repair, transcatheter mitral valve replacement therapy, transcatheter aortic replacement, etc. The above-mentioned transcatheter interventional minimally invasive treatment surgeries all require the assistance of a bending sheath to ensure that the operating instrument is delivered to the required position through the curved blood vessels, and then the minimally invasive surgery is performed.

The prior art discloses an adjustable curved guide catheter, which includes a catheter head, a fixed curved 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 to control the tube body of the catheter to rotate along the central axis of the catheter body, and the second knob is used to control the deflection of the deflectable section of the catheter. However, when the direction of the tube body of the existing adjustable curved catheter needs to be adjusted, it can only be adjusted by directly rotating the tube body of the guide catheter itself, and the rotation amount of the overall rotation of the guide catheter is difficult to control, and it is easy to rotate too much or too little.

Summary of the invention

The purpose of the present invention is to overcome the deficiencies of the prior art and provide an adjustable bending sheath capable of quantitatively regulating the bending angle of a tube body.

In order to solve the above technical problems, the present invention provides an adjustable bending sheath, including a sheath tube assembly and a handle assembly, the handle assembly including an inner core, a fixed seat and a driving member, 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 to the inner core, the driving member is fixedly connected to the inner core, the driving member is rotatably connected to the fixed seat, one of the fixed seat and the driving member includes an elastic element, and the other includes an angle dividing part, the angle dividing part includes a plurality of dividing elements arranged at intervals, and when the driving member rotates relative to the fixed seat, the elastic element moves between the plurality of dividing elements.

In the adjustable bending sheath of the present invention, one of the fixed seat and the driving member includes an elastic element, and the other includes an angle indexing portion. When the driving member rotates relative to the fixed seat, the elastic element cooperates with the angle indexing portion to enable the driving member to rotate quantitatively. Since the proximal end of the sheath tube assembly is fixedly connected to the inner core, and the driving member is fixedly connected to the inner core, the quantitative rotation of the driving member drives the quantitative rotation of the sheath tube assembly to achieve precise control of the bending angle direction of the sheath tube assembly, thereby avoiding the situation where the sheath tube assembly rotates too much or too little as a whole.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

FIG1 is a schematic diagram of the three-dimensional structure of an adjustable bending sheath according to a first embodiment of the present invention;

FIG2 is a perspective exploded schematic diagram of the adjustable bending sheath in FIG1 ;

FIG3 is a perspective exploded schematic diagram of the adjustable bending sheath in FIG1 from another perspective;

FIG4 is a perspective exploded schematic diagram of the adjustable bending sheath in FIG3 after removing the outer shell and the bending adjusting component;

FIG5 is a schematic diagram of the three-dimensional structure of the sheath tube assembly, inner core, sliding member and fixing member of the adjustable bending sheath in FIG2;

FIG6 is a schematic diagram of the exploded three-dimensional structure of the bending adjusting component and the traction component in FIG2 ;

7 is a cross-sectional schematic diagram of the sheath tube assembly of the adjustable bending sheath of the present invention;

FIG8 is a schematic diagram of a three-dimensional assembly structure of the fixing base and the driving member in FIG4 ;

FIG9 is a schematic diagram of the exploded three-dimensional structure of the fixing base and the driving member in FIG8 ;

FIG10 is a schematic diagram of the exploded three-dimensional structure of the fixing base and the driving member in FIG9 from another perspective;

FIG11 is a schematic cross-sectional view of the fixing seat and the driving member in FIG8 ;

FIG12 is a schematic diagram of a further three-dimensional structural assembly of the adjustable bending sheath of FIG2;

FIG13 is a front view of the adjustable curved sheath in FIG1;

FIG14 is a cross-sectional view along line XIV-XIV in FIG13;

15 is a schematic diagram of a three-dimensional structure of an adjustable bending sheath placed on a support platform according to the first embodiment of the present invention;

FIG16 is a perspective exploded schematic diagram of the adjustable bending sheath and the support platform in FIG15;

17 is a schematic diagram of a three-dimensional assembly structure of a fixing seat and a driving member of an adjustable bending sheath according to a second embodiment of the present invention;

FIG18 is a schematic diagram of the exploded three-dimensional structure of the fixing base and the driving member in FIG17;

FIG19 is a schematic exploded view of the fixed base and the driving member in FIG18 from another perspective;

FIG20 is a cross-sectional schematic diagram of the fixing seat and the driving member in FIG17;

21 is a schematic diagram of a three-dimensional assembly structure of a fixing seat and a driving member of an adjustable bending sheath according to a third embodiment of the present invention;

FIG22 is a schematic diagram of the exploded three-dimensional structure of the fixing seat and the driving member in FIG21;

FIG23 is a schematic diagram of the exploded three-dimensional structure of the fixing base and the driving member in FIG18 from another perspective;

FIG24 is a schematic diagram of the exploded three-dimensional structure of the fixing seat and the driving member of the adjustable bending sheath according to the fourth embodiment of the present invention;

FIG25 is a cross-sectional schematic diagram of the fixed seat and the driving member in FIG24 after being assembled;

FIG. 26 is a schematic diagram of the exploded three-dimensional structure of the fixing seat and the driving member of the adjustable bending sheath according to the fifth embodiment of the present invention.

DETAILED DESCRIPTION

The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

In addition, the following descriptions of the embodiments are made with reference to the attached drawings to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

Definition of orientation: For the sake of clarity, the end close to the operator during surgery is referred to as the "proximal end" and the end away from the operator is referred to as the "distal end". This definition is only for the convenience of expression and cannot be understood as a limitation of the present invention. "Axial" refers to the axial direction of the sheath.

First embodiment

Please refer to Figures 1 to 3. The present invention provides an adjustable bending sheath 100, including a sheath tube assembly 20 and a handle assembly 40. The handle assembly 40 includes an inner core 41, an outer shell 42 sleeved on the inner core 41, a bending adjustment component 43 rotatably sleeved on the inner core 41, a fixed seat 44 and a driving member 45 arranged at the proximal end of the inner core 41. 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 to the inner core 41. The driving member 45 is fixedly connected to the inner core 41, and the driving member 45 is rotatably connected to the fixed seat 44. One of the fixed seat 44 and the driving member 45 includes an elastic element 46, and the other includes an angle dividing portion 47. The angle dividing portion 47 includes a plurality of dividing elements 471 arranged at intervals. When the driving member 45 rotates relative to the fixed seat 44, the elastic element 46 moves between the plurality of dividing elements 471.

In the adjustable bending sheath 100 of the present invention, one of the fixed seat 44 and the driving member 45 includes an elastic element 46, and the other includes an angle indexing portion 47. When the driving member 45 rotates relative to the fixed seat 44, the elastic element 46 cooperates with the angle indexing portion 47 so that the driving member 45 can rotate quantitatively. Since the proximal end of the sheath tube assembly 20 is fixedly connected to the inner core 41, and the driving member 45 is fixedly connected to the inner core 41, the quantitative rotation of the driving member 45 drives the quantitative rotation of the sheath tube assembly 20, so as to achieve precise control of the bending angle direction of the sheath tube assembly 20, and avoid the situation where the sheath tube assembly 20 rotates too much or too little as a whole.

It can be understood that the distal end of the sheath assembly 20 is provided with an adjustable bend section 21, and the bend adjusting component 43 is used to adjust the bending angle of the adjustable bend section 21, so that the distal end of the sheath assembly 20 forms an adjustment angle. When the driving member 45 rotates relative to the fixed seat 44, the elastic element 46 moves between the multiple indexing elements 471, so that the driving member 45 drives the inner core 41 to rotate, and the rotation of the inner core 41 drives the sheath assembly 20 to rotate, so as to facilitate the adjustment of the direction of the adjustment angle of the adjustable bend section 21. The proximal end of the sheath assembly 20 can be connected to the inner core 41 by, but not limited to, glue bonding, clamping or thermal insulation, and the sheath assembly 20 is coaxial with the inner core 41.

Please refer to Figures 4 to 9 together. The sheath assembly 20 includes an inner membrane 201, a reinforcing tube 202 sleeved on the inner membrane 201, and an outer tube 203 sleeved on the reinforcing tube 202. The inner membrane 201 can be a flexible tube made of flexible materials such as polytetrafluoroethylene (PTFE), which is easy to bend. The reinforcing tube 202 can be a metal woven mesh structure or a metal tube cut mesh structure. The reinforcing tube 202 has a certain rigidity and can bend in the axial direction, thereby providing support for the sheath assembly 20, avoiding torsional deformation of the sheath assembly 20 in the radial direction, and at the same time does not affect the bending of the adjustable bending section of the sheath assembly 20. The outer tube 203 is made of a material with a certain hardness such as block polyetheramide resin (PEBAX) to protect the sheath assembly 20. The hardness of the outer tube 203 corresponding to the adjustable bend section 21 is less than the hardness of other parts of the outer tube 203, so as to protect the sheath assembly 20 while avoiding the influence on the bending of the adjustable bend section 21. 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 cavity 205 that completely penetrates from the proximal end to the distal end along the axis of the sheath assembly 20. The end of the sheath assembly 20 is a guide slider 23 with a smooth surface, i.e., a Tip head. A developing ring (not shown in the figure) is arranged near the end of the Tip head. The developing ring includes but is not limited to a tantalum ring, etc., so that it can be accurately known whether the distal end of the sheath assembly 20 has reached the specified position under the developing device.

As shown in Figures 5 and 6, the sheath assembly 20 also includes a traction member 25 connected to the adjustable bend section 21. The traction member 25 includes a traction wire 251 and an anchoring ring 253 arranged at the distal end of the traction wire 251. The anchoring ring 253 is connected to the adjustable bend section 21, and preferably, the anchoring ring 253 and the adjustable bend section 21 are coaxial. Specifically, the anchoring ring 253 can be hot-melted into one with the adjustable bend section 21. The connection method between the distal end of the traction wire 251 and the anchoring ring 253 includes but is not limited to bonding, welding, hot melting or knotting. The tube wall of the sheath assembly 20 is provided with a filament cavity along the axial direction, and the traction wire 251 is movably accommodated in the filament cavity of the sheath assembly 20. Specifically, the filament cavity can be provided in the tube wall of the reinforcing tube 202 or the outer tube 203 of the sheath assembly 20, that is, the filament cavity is embedded in the tube wall of the reinforcing tube 202 or the outer tube 203. The traction wire 251 is used to pull the adjustable curved section 21 to bend or to restore the adjustable curved section 21 to be straight after the traction force on the traction wire 251 is released. The traction wire 251 can be made of metal materials, such as stainless steel, tungsten alloy, cobalt-chromium alloy or nickel-titanium alloy, etc., or can be made of polymer materials with a certain strength. The proximal end of the traction wire 251 can be connected to the bending adjustment component 43, so that the traction wire 251 pulls the adjustable curved section 21 to bend or restore it to be straight by operating the bending adjustment component 43.

As shown in Fig. 4 and Fig. 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 guide slide portion 417 located 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 fixedly sleeved at the distal end of the distal core tube 4110, and a second positioning ring 4114 fixedly sleeved at the proximal end of the distal core tube 4110. The outer peripheral wall of the first positioning ring 4112 is provided with at least one circle of grooves 4115 along the circumferential direction, and the second positioning ring 4114 is provided with at least one positioning groove 4116 along the circumferential direction on a side facing the first positioning ring 4112. The outer peripheral wall of the distal core tube 4110 is provided with a through groove 4117 along the axial direction, and the second positioning ring 4114 is provided with a notch 4118 communicating with the through groove 4117 along its radial direction. The guide slide portion 417 includes a slide tube 4171 fixedly connected to the proximal end of the distal core tube 4110, and a baffle 4173 disposed at the proximal end of the slide tube 4171. The inner cavity of the slide tube 4171 is connected to the inner cavity of the distal core tube 4110, and the outer peripheral wall of the slide tube 4171 is axially provided with a guide groove 4175 connected to the through groove 4117. The connecting portion 415 includes a proximal core tube 4150 connected to the side of the baffle 4173 away from the slide tube 4171 and a plurality of clamping members 4153 disposed at the proximal end of the proximal core tube 4150. The inner cavity of the proximal core tube 4150 is axially connected to the inner cavity of the slide tube 4170. The plurality of clamping 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 also provided with a plurality of external clamping grooves 4155 . Specifically, the outer peripheral wall of the proximal core tube 4150 is axially provided with a plurality of clamping grooves 4155 , and the plurality of clamping grooves 4155 are arranged in a circle along the circumference of the proximal core tube 4150 .

As shown in FIGS. 2 to 6 , the bending adjusting component 43 includes a sliding member 430 and a bending adjusting member 437 sleeved on the sliding member 430. The proximal end of the traction wire 251 is fixedly connected to the sliding member 430, and the sliding member 430 is sleeved on the guide slide 417 of the inner core 41 in an axially sliding manner. The sliding member 430 and the bending adjusting member 437 are threadedly matched, and the sliding member 430 is driven to move along the axial direction of the inner core 41 by rotating the bending adjusting member 437, thereby driving the traction wire 251 to pull the adjustable bending section 21 to bend or restore straightness.

Specifically, the sliding member 430 includes a slider 431 sleeved on the guide slide 417, a connecting rod 432 disposed at the distal end of the slider 431, an identification member 434 disposed at the distal end of the connecting rod 432, and a traction wire fixing block 435 connected to the slider 431. The slider 431 is provided with a notch 4310 along the axial direction, and the guide slide 41 is accommodated in the notch 4310. The traction wire fixing block 435 is disposed on the inner wall of the notch 4310 and extends radially to the notch 4310, and the traction wire fixing block 435 is used to fix the proximal end of the traction wire 251. It can be understood that the end of the traction wire fixing block 435 is provided with a fixing hole along the axial direction, and the proximal end of the traction wire 251 is fixedly connected in the fixing hole. The traction wire fixing block 435 and the slider 431 can be fixedly connected by means of clamping, screwing or gluing, or can be made of one piece. The slider 431 is provided with an external thread 4312, and the bending adjusting member 437 is provided with an inner cavity penetrating its proximal end surface and distal end surface along the axial direction, and the inner peripheral wall of the inner cavity of the bending adjusting member 437 is provided with an internal thread 4371 matching with the external thread 4312. The identification member 434 can 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 frames 420 that are detachably engaged with each other. The outer peripheral wall of at least one of the frames 420 is provided with an observation window 421 along the axial direction. The frame 420 is provided with an indication scale 423 on at least one side of the observation window 421. The indication scale 423 is used to indicate the position of the identification member 434 to measure the length of the sliding member 430 sliding along the axial direction. Specifically, the scale of the position of the identification member 434 corresponding to the indication scale 423 is confirmed through the observation window 421. The corresponding bending angle of the adjustable bending section 21 can be known through the reading of the scale. A positioning recess 425 is provided at the intersection of the outer peripheral walls of the two frames 420.

Please refer to Figures 8 to 11 together. The fixed seat 44 includes a connecting ring 441, and the connecting ring 441 includes a connecting hole 442 that penetrates the fixed seat 44 in the axial direction. The driving member 45 includes a connecting tube 451, and the connecting tube 451 is rotatably inserted into the connecting hole 442. In this way, the driving member 45 can be rotatably connected to the fixed seat 44. In this embodiment, the fixed seat 44 also includes a fixing ring 445 arranged at one end of the connecting ring 441. The fixing ring 445 is coaxial with the connecting ring 441, and the inner cavity of the fixing ring 445 is connected to the inner cavity of the connecting ring 441. The inner diameter of the fixing ring 445 is larger than the inner diameter of the connecting ring 441, and the outer diameter of the fixing ring 445 is larger than the outer diameter of the connecting ring 441, so that the fixed seat 44 has a circular step structure, that is, a step 446 is formed near the inner cavity of the fixing ring 445 near the connecting ring 441. The outer peripheral wall of the fixing ring 445 is provided with two symmetrical fixing surfaces 447, and each fixing surface 447 extends along the axial direction of the fixing ring 445. The outer peripheral wall of the connecting ring 441 is provided with at least two spaced mounting holes 448, and each mounting hole 448 extends along the radial direction of the connecting ring 441. Preferably, the outer peripheral wall of the connecting ring 441 is provided with at least two symmetrical mounting holes 448. The elastic element 46 is provided on the outer peripheral wall of the connecting ring 441. In this embodiment, the elastic element 46 is installed in the mounting hole 448. Specifically, the elastic element 46 can be a plunger elastic screw, and the mounting hole 448 is used to install the plunger elastic screw. The plunger elastic screw includes a housing 462, a spring and a steel ball 465 located in the housing 462, and the spring is connected to the steel ball 465, and the elasticity of the spring can be used to push the steel ball 465 to move.

The driving member 45 also includes a driving cylinder 453 coaxial with the connecting cylinder 451, and the connecting cylinder 451 is accommodated in the driving cylinder 453. The end of the connecting cylinder 451 is connected to the driving cylinder 453 through a connecting plate, and an annular groove 454 is formed between the driving cylinder 453 and the connecting cylinder 451, and the connecting ring 441 is rotatably accommodated in the annular groove 454. Specifically, the outer peripheral wall of the connecting cylinder 451 is provided with a clamping groove 4512 along the circumferential direction at the end away from the connecting plate. The inner peripheral wall of the connecting cylinder 451 is provided with a plurality of clamping edges 4514 along the axial direction, and the plurality of clamping edges 4514 are arranged along the circumferential direction of the connecting cylinder 451. A plurality of indexing elements 471 are provided on the inner peripheral wall of the driving cylinder 453, and the plurality of indexing elements 471 can be arranged at equal intervals or at non-equal intervals. In this embodiment, the plurality of indexing elements 471 are a plurality of grooves arranged at intervals on the inner circumferential wall of the driving cylinder 453. When the driving member 45 rotates relative to the fixed seat 44, the elastic element 46, i.e., the plunger elastic screw, is sequentially inserted into the plurality of grooves. The plurality of grooves can be evenly arranged along the circumference of the driving cylinder 453, i.e., the plurality of grooves are arranged at equal intervals along the circumference of the driving cylinder 453. Each groove can be matched with the elastic element 46. In this embodiment, each groove is matched with the steel ball 465, i.e., the steel ball 465 can be inserted into the groove or separated from the engagement with the groove. If the number of indexing elements 471 arranged on the inner circumferential wall of the driving cylinder 453 is N, the angle between each two adjacent indexing elements 471 is 360 divided by N. The outer circumferential wall of the driving cylinder 453 is provided with angle markings along its circumference. In this embodiment, the outer circumferential wall of the driving cylinder 453 is marked with 0 degrees, 90 degrees, 180 degrees, 270 degrees, etc. for the user to judge the angle of rotation of the driving member 45 relative to the fixed seat 44.

When assembling the fixed seat 44 and the driving member 45, first, the elastic element 46 is inserted into the corresponding mounting hole 448. Since the elastic element 46 and the mounting hole 448 are interference fit, it can be ensured that the elastic element 46 will not be separated from the mounting hole 448. Secondly, the connecting ring 441 of the fixed seat 44 is rotatably accommodated in the annular groove 454, and the connecting cylinder 451 is penetrated with the connecting hole 442 and the clamping groove 4512 is exposed. Specifically, the end of the connecting cylinder 451 is accommodated in the inner cavity of the fixed ring 445, and the step 446 is exposed outside the clamping groove 4512. Then the clamping spring 48 of the handle assembly 40 is clamped in the clamping groove 4512, so that the fixed seat 44 and the driving member 45 are locked and connected. At this time, the fixed seat 44 and the driving member 45 can rotate relative to each other, that is, after the fixed seat 44 is fixed, the driving member 45 can rotate in both directions relative to the fixed seat 44, but the fixed seat 44 and the driving member 45 cannot move relative to each other in the axial direction, that is, the fixed seat 44 and the driving member 45 cannot move independently 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 inserted into a plurality of grooves; when the driving member 45 does not rotate relative to the fixed seat 44, the steel balls 465 of the elastic element 46 are embedded in the corresponding grooves of the driving member 45 to achieve position self-locking, that is, to maintain the relative positioning of the fixed seat 44 and the driving member 45 in the absence of external force, so as to always protect the bending direction of the adjustable bending section 21 of the sheath assembly 20.

In other embodiments, the elastic element 46 may be disposed on the inner circumferential wall of the driving cylinder 453, and the plurality of indexing elements 471 may be disposed on the outer circumferential wall of the connecting ring 441. Specifically, the inner circumferential wall of the driving cylinder 453 is provided with at least two spaced mounting holes, each of which is provided with an elastic element 46, which is a plunger elastic screw. The outer circumferential wall of the connecting ring 441 is provided with a plurality of indexing elements 471 along its circumference, and the plurality of indexing elements 471 are a plurality of grooves arranged at intervals.

In other embodiments, the elastic element 46 is an elastic protrusion, which can be arranged on the outer peripheral wall of the connecting ring 441 or the inner peripheral 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 arranged on the outer peripheral wall of the connecting ring 441, the plurality of grooves are arranged on the inner peripheral wall of the driving cylinder 453 and arranged in a circle along the circumference of the driving cylinder 453. When two or more spaced elastic protrusions are arranged on the inner peripheral wall of the driving cylinder 453, the plurality of grooves are arranged on the outer peripheral wall of the connecting ring 441 and arranged in a circle along the circumference of the connecting ring 441. When the driving member 45 rotates relative to the fixing seat 44, the elastic protrusions are sequentially inserted into the plurality of grooves. When the driving member 45 does not rotate relative to the fixing seat 44, the elastic protrusions are embedded in the corresponding grooves to achieve position self-locking.

Please refer to Figures 2 to 5 together. The handle assembly 40 also includes a fixing member 491, a sealing nut 492, a sealing silicone 494 and a sealing silicone support 496. The fixing member 491 is provided with a card interface 4915, and the proximal end of the inner core 41 is penetrated by a connecting tube 451 and exposes a plurality of card connectors 4153, and the plurality of card connectors 4153 are inserted into the card interface 4915. Specifically, the fixing member 491 includes a fixing tube 4911 and an annular card 4913 fixedly sleeved on the fixing tube 4911, one end of the outer peripheral wall of the fixing tube 4911 is provided with an external thread, and the end of the fixing tube 4911 away from the external thread is provided with a card interface 4915. The sealing nut 492 is provided with an internal thread that matches the fixing tube 4911. The sealing silicone 494 is installed on the fixing member 491 through the sealing silicone support 496. The inner cavity of the adjustable bending sheath 100 is used to accommodate and pass the delivery sheath of the interventional medical device. The sealing nut 492 and the sealing silicone 494 can be wrapped around the outer circumference of the delivery sheath to seal the delivery sheath to ensure that no blood leakage occurs during the operation.

Please refer to Figures 1 to 6 and 12 to 14. When assembling the adjustable bending sheath 100, first, install the sliding member 430 on the inner core 41. Specifically, the sliding member 431 is sleeved on the guide slide 417, and the traction wire fixing block 435 is accommodated in the guide groove 4175. The proximal end of the traction wire 251 is fixedly connected to the traction 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 buckled on the positioning portion 411. The sliding member 431 can slide along the axial direction of the inner core 41 to drive the identification member 434 to slide axially, and the sliding member 431 is stopped between the second positioning ring 4114 and the blocking piece 4173. Secondly, the two frames 420 are buckled into the positioning part 411 of the inner core 41, so that the distal wall of each frame 420 is inserted into the slot 4115 of the first positioning ring 4112, and the proximal wall of each frame 420 is inserted into the positioning slot 4116 of the second positioning ring 4114. Thirdly, the bending adjusting member 437 is threadedly matched with the slider 431 and arranged on the inner core 41, and the retaining spring 4370 is clamped at the proximal end of the baffle 4173 of the inner core 41, so that the bending adjusting member 437 is stopped between the second positioning ring 4114 and the retaining spring to limit the movement of the bending adjusting member 437 in the axial direction, that is, the bending adjusting member 437 can only rotate along the axis of the inner core 41. Then, the fixing seat 44 and the driving member 45 installed in one body are installed to the proximal end of the inner core 41, so that the proximal end of the inner core 41 is penetrated and fixedly connected to the connecting tube 451. Specifically, the connecting portion 415 is inserted into the inner cavity of the connecting tube 451 through the inner cavity of the fixing seat 44, and the plurality of snap edges 4514 are snapped into the plurality of snap grooves 4155 of the proximal core tube 4150, respectively. The plurality of snap edges 4514 are snapped into the plurality of snap grooves 4155 in a one-to-one correspondence. Finally, the fixing member 491 is installed to the proximal end of the inner core 41. Specifically, the plurality of snap members 4153 at the proximal end of the inner core 41 are inserted into the snap interface 4915 of the fixing tube 4911 and snapped into the inner circumferential wall of the fixing tube 4911 to lock the driving member 45 and the inner core 41. The sealing silicone 495 is installed at the proximal end of the fixing member 491 through the sealing silicone support member 496, and the sealing nut 492 is threadedly connected to the fixing member 491.

As shown in Figures 15 and 16, the bending adjustment component 43 is used to adjust the bending angle of the adjustable bending section 21 of the sheath assembly 20 so that the distal end of the sheath assembly 20 forms an adjustment angle, and the cooperation between the fixed seat 44 and the driving member 45 is used to adjust the direction of the adjustment angle of the adjustable bending section 21. When using the adjustable bending sheath 100, the housing 42 and the fixed seat 44 need to be fixed by the support platform 300 or the operator's hand. The support platform 300 includes a bracket 301, a bracket 305 slidably disposed on the bracket 301, and a locking member 309 for positioning the bracket 305 on the bracket 301. The bracket 301 includes a support bar 302 extending obliquely, and the support bar 302 has a high guide groove 303 along its length. The bracket 305 includes a sliding bar 306 slidably received in the guide groove 303, a first positioning fork 307 and a second positioning fork 308 spaced apart on the sliding bar 306, and the first positioning fork 307 and the second positioning fork 308 are used to fix the housing 42 and the fixing seat 44 respectively. The locking member 309 passes through the support bar 302 and abuts against the sliding bar 306 in the guide groove 303 to position the bracket 305. The housing 42 and the fixing seat 44 are fixed on the bracket 305, specifically, the first positioning fork 307 is clamped to the positioning recess 425 of the housing 42, and the second positioning fork 308 is clamped to the fixing surface 447 of the fixing seat 44.

During interventional surgery, for ease of operation, the bracket 305 is used to fix the fixing seat 44 and the housing 42, so that the interface of the indicator scale 423 of the housing 42 always faces upward. When the sheath assembly 20 enters the body, if the bending angle of the adjustable curved section 21 needs to be adjusted, the inner core 41 can be driven to rotate by rotating the driving member 45. The driving member 45 can rotate clockwise or counterclockwise according to actual needs, thereby adjusting the bending angle of the adjustable curved section 21.

During the process of rotating the driving member 45, the elastic element 46 moves between the multiple dividing elements 471 to adjust the rotation angle of the inner core 41, thereby adjusting the bending angle direction of the adjustable bending section 21. By setting multiple dividing elements 471 with equal spacing on the inner peripheral wall of the driving member 45, the direction of the sheath tube assembly 20 can be controlled by equal amount and degree, and the magnitude of the rotation force can be controlled by the elastic deformation of the elastic element 46. Therefore, during the use of the adjustable bending sheath 100, it is not necessary to rotate the entire handle assembly 40. The bending adjusting member 437 and/or the driving member 45 can be rotated separately to make the shell 42 and the fixing seat 44 stationary in the original position. It is easy to use and operate, and the rotation amount of the overall rotation of the sheath tube assembly 20 can be accurately controlled to avoid excessive or insufficient rotation, thereby improving the success rate of the operation and reducing the risk of the operation.

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

Second embodiment

Please refer to FIGS. 17 to 20 . The structure of the second embodiment of the adjustable bending sheath provided by the present invention is similar to that of the first embodiment, except that the structures of the fixing seat 44 a and the driving member 45 a in the second embodiment are slightly different from those of the fixing seat 44 and the driving member 45 in the first embodiment, as follows:

In the second embodiment, the connecting ring 441 includes a first side wall 4410 facing the driving member 45a, and a connecting hole 442 penetrating the fixing seat 44a is axially provided in the middle of the first side wall 4410. The driving member 45a includes a driving portion 453a connected to the connecting cylinder 451, and the driving portion 453a is provided with a second side wall 4531 facing the first side wall 4410 around the connecting cylinder 451, and the elastic element 46 is provided on the first side wall 4410, and a plurality of indexing elements 471 are provided on the second side wall 4531. Specifically, the fixing seat 44a is a circular cylindrical structure, and the first side wall 4410 of the fixing seat 44a is provided with at least two spaced mounting holes 448, and each mounting hole 448 extends along the axial direction of the connecting ring 441. Preferably, the first side wall 4410 is provided with at least two symmetrical mounting holes 448. In this embodiment, the elastic element 46 is installed in the mounting hole 448, and specifically, the elastic element 46 is a plunger elastic screw. The mounting hole 448 is used to install the plunger elastic screw. The first side wall 4410 of the fixed seat 44a is also provided with a circular groove 4413. The purpose of providing the circular groove 4413 is to avoid empty materials, reduce wall thickness, and facilitate mold opening. Of course, the fixed seat 44a may not be provided with the circular groove 4413. The connecting cylinder 451 is convexly arranged in the middle of the second side wall 4531 of the driving part 453a, and the inner cavity of the connecting cylinder 451 is connected to the inner cavity of the driving part 453a. A plurality of dividing elements 471 are arranged on the second side wall 4531 along the circumference of the connecting cylinder 451, and the plurality of dividing elements 471 can be arranged at equal intervals or at non-equal intervals. In this embodiment, the plurality of dividing elements 471 are a plurality of grooves arranged at intervals on the second side wall 4531. When the driving member 45a rotates relative to the fixed seat 44a, the elastic element 46, i.e., the plunger elastic screw, is sequentially inserted into the plurality of grooves. The plurality of grooves can be evenly arranged along the circumference of the connecting tube 451, that is, the plurality of grooves are evenly spaced along the circumference of the connecting tube 451. Each groove can match the elastic element 46. In this embodiment, each groove matches the steel ball 465 of the elastic element 46, that is, the steel ball 465 can be inserted into the groove or disengaged from the groove. The use method and beneficial effects of the second embodiment are the same as those of the first embodiment, and will not be repeated here.

In other embodiments, the elastic element 46 is disposed on the second side wall 4531 of the driving cylinder 453a, and a plurality of indexing elements 471 are disposed on the first side wall 4410 of the connecting ring 441. Specifically, at least two spaced mounting holes are disposed on the second side wall 4531 along the circumference of the connecting cylinder 451, and an elastic element 46 is disposed in each mounting hole, and the elastic element 46 is a plunger elastic screw. A plurality of indexing elements are disposed on the first side wall 4410 along its circumference, and the plurality of indexing elements are a plurality of grooves arranged at intervals.

In other embodiments, the elastic element 46 is an elastic protrusion, which can be arranged on the first side wall 4410 of the connecting ring 441 or the second side wall 4531 of the driving cylinder 453a. The plurality of indexing elements 471 are a plurality of grooves. Specifically, when two or more spaced elastic protrusions are arranged on the first side wall 4410, the plurality of grooves are arranged on the second side wall 4531 and arranged in a circle along the circumference of the connecting cylinder 451. When two or more spaced elastic protrusions are arranged on the second side wall 4531, the plurality of grooves are arranged on the first side wall 4410 and arranged in a circle along the circumference of the connecting ring 441. When the driving member 45a rotates relative to the fixing seat 44a, the elastic protrusions are sequentially inserted into the plurality of grooves. When the driving member 45a does not rotate relative to the fixing seat 44a, the elastic protrusions are embedded in the corresponding grooves to achieve position self-locking.

Third embodiment

Please refer to FIGS. 21 to 23 , the structure of the third embodiment of the adjustable bending sheath provided by the present invention is similar to that of the first embodiment, except that the structures of the fixing seat 44 b and the driving member 45 b in the third embodiment are slightly different from those of the fixing seat 44 and the driving member 45 in the first embodiment, as follows:

In the third embodiment, the elastic element 46a is a convex ridge with elasticity, and the multiple indexing elements 471a of the angle indexing portion 47a are multiple grooves arranged at intervals. When the driving member 45b rotates relative to the fixed seat 44b, the elastic convex ridges are sequentially inserted into the multiple grooves. When the driving member 45b does not rotate relative to the fixed seat 44b, the elastic convex ridges are embedded in the corresponding grooves. Specifically, the outer peripheral wall of the connecting ring 441 of the fixed seat 44b is provided with multiple elastically deformable elastic elements 46a along the circumference of the connecting ring 441. The elastic element 46a is an inclined convex ridge, which is flexible and can be elastically deformed when squeezed. Each elastic element 46a includes a connecting block 467 convexly arranged on the outer peripheral wall of the connecting ring 441 and an elastic positioning strip 468 extending obliquely to one side from the end of the connecting block 467. The inclination angle range of the elastic positioning strip 468 relative to the corresponding connecting block 467 is within 0 degrees to 90 degrees. Preferably, the inclination angle of the elastic positioning strip 468 relative to the corresponding connecting block 467 is about 30 degrees. In this embodiment, a plurality of elastic elements 46a are arranged in a circle at uniform intervals along the circumference of the connecting ring 441 on the outer peripheral wall of the connecting ring 441, that is, a plurality of elastic positioning strips 468 are arranged in a circle at uniform intervals along the circumference of the connecting ring 441. An annular groove 454 is formed between the driving cylinder 453 and the connecting cylinder 451, and the indexing element 471a is a groove provided on the inner peripheral wall of the driving cylinder 453 facing the annular groove 454. In this embodiment, a plurality of grooves are provided on the inner peripheral wall of the driving cylinder 453, and the plurality of grooves are arranged in a circle along the circumference of the driving cylinder 453, and the plurality of grooves can match the convex ridges.

When assembling the fixed seat 44b and the driving member 45b, firstly, the connecting tube 451 of the driving member 45b is rotatably accommodated in the connecting hole 442 of the fixed seat 44b and the slot 4512 is exposed, and at the same time, the connecting ring 441 is accommodated in the ring groove 454, and the convex edge of the fixed seat 44b matches the groove of the driving member 45b. Then, the clamping spring 48 of the handle assembly 40 is clamped in the slot 4512, so that the fixed seat 44b and the driving member 45b are locked and connected. At this time, the driving member 45b can rotate unidirectionally relative to the fixed seat 44b, but the fixed seat 44b and the driving member 45b cannot move relative to each other in the axial direction. The installation method of the fixed seat 44b and the driving member 45b and the inner core 41 is the same as that of the first embodiment, and will not be repeated here.

The method of use and 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 fixed by the bracket 305 or held by the operator, the driving member 45b rotates unidirectionally relative to the fixing seat 44b, that is, the driving member 45b rotates along the inclination angle direction of the convex edge, and the elastic positioning strips 468 are sequentially inserted into the corresponding multiple grooves. When the driving member 45b does not need to be rotated, the elastic positioning strips 468 are embedded in the grooves to achieve position self-locking. For example, when rotating to a certain position, multiple elastic positioning strips 468 are respectively inserted into multiple grooves to achieve the position self-locking function, which is conducive to the smooth operation.

During interventional surgery, the bracket 305 can be used to fix the fixing seat 44b. When the sheath assembly 20 enters the body, if the bending angle of the adjustable curved section 21 needs to be adjusted, the inner core 41 can be driven to rotate along the ridge inclination direction of the fixing seat 44b by rotating the driving member 45b, thereby adjusting the bending angle of the adjustable curved section 21. Due to the uniformly distributed ridge structure on the fixing seat 44b, the bending angle of the sheath assembly 20 can be precisely and equally controlled.

In other embodiments, the number of ridges on the outer circumferential wall of the connecting ring 441 may be two or more, the number of grooves on the inner circumferential wall of the driving cylinder 453 may be multiple, and the multiple grooves are arranged at uniform or non-uniform intervals along the circumference of the driving cylinder 453.

In other embodiments, the angle indexing portion may be a toothed ring, which is arranged along the inner circumferential wall of the driving cylinder 453. The toothed ring includes a plurality of toothed grooves, and the indexing element is a toothed groove, and the plurality of toothed grooves can match the convex ridges.

Fourth embodiment

Please refer to FIG. 24 and FIG. 25 together. The structure of the fourth embodiment of the adjustable bending sheath provided by the present invention is similar to that of 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 those of the fixing seat 44b and the driving member 45b in the third embodiment, 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 elements 46a are provided around the connecting hole 442 on the first side wall 4410, and the plurality of elastic elements 46a are arranged in a circle along the circumference of the connecting hole 442. Preferably, the plurality of elastic elements 46a are arranged at uniform intervals. Each elastic element 46a is an inclined ridge, which is flexible and can be elastically deformed when squeezed. Each elastic element 46a includes a connecting block 467 convexly provided on the first side wall 4410 and an elastic positioning strip 468 extending obliquely to one side from the end of the connecting block 467. The inclination angle of the elastic positioning strip 468 relative to the corresponding connecting block 467 is within a range of 0 to 90 degrees; preferably, the inclination angle of the connecting block 467 corresponding to the elastic positioning strip 468 is about 30 degrees. The angle indexing portion 47b is a toothed ring disposed between the driving cylinder 453 and the connecting cylinder 451, and the toothed ring is arranged in a circle along the circumference of the connecting cylinder 451. The toothed ring includes a plurality of toothed grooves, and the indexing element 471b is a toothed groove, and the plurality of toothed grooves can match the convex ridges. Preferably, the plurality of toothed grooves are arranged in a circle at uniform intervals along the circumference of the toothed ring. The method of use and the beneficial effects of the fourth embodiment are the same as those of the third embodiment, and will not be described in detail herein.

In other embodiments, the plurality of indexing elements may be a plurality of grooves spaced apart on the second side wall 4531 of the driving portion 453 a , and the plurality of grooves cooperate with a plurality of ridges disposed on the first side wall 4410 of the connecting ring 441 .

Fifth embodiment

Referring to FIG. 26 , the structure of the fifth embodiment of the adjustable bending sheath provided by 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 those of the fixing seat 44c and the driving member 45c in the fourth embodiment, as follows:

In the fifth embodiment, the side of the fixing ring 445 of the fixing seat 44d facing the driving member 45d is provided with a plurality of indexing elements 471a on the circumferential side of the connecting hole 442, and the plurality of indexing elements 471a are a plurality of grooves arranged at intervals. The plurality of grooves can be arranged at uniform intervals or at non-uniform intervals. A plurality of elastic elements 46a are provided on the connecting plate between the end of the connecting cylinder 451 of the driving member 45d and the driving cylinder 453, and the plurality of elastic elements 46a are arranged in a circle along the circumference of the connecting cylinder 451, and each elastic element 46a is a flexible ridge; the plurality of ridges match the plurality of grooves.

The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, multiple improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims (15)

1. An adjustable bending sheath, characterized in that it includes a sheath tube assembly and a handle assembly, the handle assembly including an inner core, a fixed seat, a driving member and a bending adjustment component rotatably mounted on the inner core, 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 to the inner core, the driving member is fixedly connected to the inner core, the driving member is rotatably connected to the fixed seat, one of the fixed seat and the driving member includes an elastic element, and the other includes an angle dividing part, the angle dividing part includes a plurality of dividing elements arranged at intervals, when the driving member rotates relative to the fixed seat, the elastic element moves between the plurality of dividing elements to adjust the rotation angle of the inner core, thereby controlling the rotation amount of the sheath tube assembly as a whole; the sheath tube assembly includes a traction member, the traction member is connected to the adjustable bending section and the bending adjustment component, the bending adjustment component is used to drive the traction member to pull the adjustable bending section to adjust the bending angle of the sheath tube assembly. 2. The adjustable bending sheath according to claim 1 is characterized in that the multiple dividing elements are arranged at equal intervals or at non-equal intervals. 3. The adjustable bending sheath according to claim 1 is characterized in that the fixing seat includes a connecting ring, the connecting ring includes a connecting hole that penetrates the fixing seat axially, and the driving member includes a connecting tube that is rotatably inserted into the connecting hole. 4. The adjustable bending sheath according to claim 3, characterized in that the driving member comprises 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 accommodated in the annular groove, the elastic element is arranged on the outer peripheral wall of the connecting ring, and the plurality of dividing elements are arranged on the inner peripheral wall of the driving cylinder; or The elastic element is arranged on the inner peripheral wall of the driving cylinder, and the plurality of dividing elements are arranged on the outer peripheral wall of the connecting ring. 5. The adjustable bending sheath according to claim 4 is characterized in that the elastic element is a plunger elastic screw or an elastic protrusion, and the multiple dividing elements are a plurality of grooves arranged at intervals, and when the driving member rotates relative to the fixed seat, the plunger elastic screw or the elastic protrusion is sequentially inserted into the plurality of grooves. 6. The adjustable bending sheath according to claim 5 is characterized in that a mounting hole is radially provided on the outer circumferential wall of the connecting ring or the inner circumferential wall of the driving cylinder, and the elastic element is a plunger elastic screw, and the plunger elastic screw is arranged in the mounting hole. 7. The adjustable bending sheath according to claim 4 is characterized in that the elastic element is a convex ridge, and the multiple dividing elements are a plurality of grooves or tooth-shaped grooves arranged at intervals, and when the driving member rotates relative to the fixed seat, the convex ridge is sequentially inserted into the plurality of grooves or the plurality of tooth-shaped grooves. 8. The adjustable bending sheath according to claim 3 is characterized in that the connecting ring includes a first side wall facing the driving member, the driving member includes a driving portion connected to the connecting tube, the driving portion is provided with a second side wall facing the first side wall around the connecting tube, the elastic element is provided on the first side wall, and the plurality of dividing elements are provided on the second side wall; or The elastic element is disposed on the second side wall, and the plurality of dividing elements are disposed on the first side wall. 9. The adjustable bending sheath according to claim 8 is characterized in that the elastic element is a plunger elastic screw or an elastic protrusion, and the multiple dividing elements are a plurality of grooves arranged at intervals, and when the driving member rotates relative to the fixed seat, the plunger elastic screw or the elastic protrusion is sequentially inserted into the plurality of grooves. 10. The adjustable bending sheath according to claim 9, characterized in that the first side wall or the second side wall is provided with a mounting hole along the axial direction, and the elastic element is a plunger elastic screw, and the plunger elastic screw is arranged in the mounting hole. 11. The adjustable bending sheath according to claim 8 is characterized in that the elastic element is a convex ridge, and the multiple dividing elements are a plurality of grooves or tooth-shaped grooves arranged at intervals, and when the driving member rotates relative to the fixed seat, the convex ridge is sequentially inserted into the plurality of grooves or the plurality of tooth-shaped grooves. 12. The adjustable bending sheath according to claim 3 is characterized in that the handle assembly also includes a retaining spring, the outer peripheral wall of the connecting tube is provided with a retaining groove, the connecting tube passes through the connecting hole and exposes the retaining groove, and the retaining spring is retained in the retaining groove. 13. The adjustable bending sheath according to claim 3 is characterized in that the proximal end of the inner core is penetrated and fixedly connected to the connecting tube. 14. The adjustable bending sheath according to claim 13 is characterized in that the handle assembly also includes a fixing part, a plurality of clips are provided at the proximal end of the inner core, the fixing part is provided with a clip interface, the proximal end of the inner core passes through the connecting tube and exposes the plurality of clips, and the plurality of clips are inserted into the clip interface. 15. The adjustable bending sheath according to claim 13 is characterized in that the proximal end of the inner core is also provided with a plurality of snap-in grooves, the inner peripheral wall of the connecting tube is provided with a plurality of snap-in edges, and the plurality of snap-in edges are snap-in with the plurality of snap-in grooves in a one-to-one correspondence.