Adjustable curved sheath

Abstract

The present invention provides an adjustable bending sheath, comprising a sheath tube assembly and a handle assembly, wherein the distal end of the sheath tube assembly is provided with an adjustable bending section. The handle assembly comprises a housing, a sliding member, and a bending adjusting member sleeved on the sliding member, and the sheath tube assembly comprises a traction member, which connects the adjustable bending section and the sliding member. The bending adjusting member is rotated to drive the sliding member to move axially, thereby driving the traction member to pull the adjustable bending section to adjust the bending angle of the adjustable bending section. An observation window is axially provided on the outer peripheral wall of the housing, and an indicator scale is provided on at least one side of the observation window of the housing. The sliding member comprises an identification member, and the axial movement of the identification member and the indicator scale corresponding to the identification member can be observed through the observation window to visualize the bending angle of the adjustable bending section. The adjustable bending sheath of the present invention obtains the bending angle change of the distal end of the sheath tube assembly through the end of the handle assembly, thereby realizing a visual design of the bending angle adjustment.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an adjustable curved sheath. Background Art

[0002] Transcatheter interventional therapy is a minimally invasive procedure that uses medical imaging technology to guide specialized catheters, guidewires, and other precision instruments into the human body to diagnose and locally treat pathological changes. Representative cardiac interventional procedures include transcatheter mitral valve repair, transcatheter mitral valve replacement, and transcatheter aortic replacement. These minimally invasive transcatheter interventional procedures all require a sheath to assist in delivering the instrument through the tortuous vessels to the desired location, allowing for minimally invasive surgery.

[0003] The prior art discloses an adjustable bend guide catheter, which 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 being used to control the rotation of the catheter body along the central axis of the catheter body, and the second knob being used to control the deflection of the deflectable section of the catheter. However, when the direction of the catheter body needs to be adjusted, existing adjustable bend catheters can only be adjusted by directly rotating the guide catheter body itself. However, the overall rotation of the guide catheter is difficult to control, and it is easy to over-rotate or under-rotate. Summary of the Invention

[0004] The purpose of the present invention is to overcome the deficiencies of the prior art and provide an adjustable bending sheath capable of quantitatively controlling the bending angle of a tube body, and also to provide an adjustable bending sheath with a visually adjustable bending angle.

[0005] 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.

[0006] The present invention also provides an adjustable bending sheath, comprising a sheath tube assembly and a handle assembly, wherein the distal end of the sheath tube assembly is provided with an adjustable bending section, the handle assembly comprises an outer shell, a sliding member and a bending adjusting member sleeved on the sliding member, the sheath tube assembly comprises a traction member, the traction member connects the adjustable bending section and the sliding member; the bending adjusting member is rotated to drive the sliding member to move axially, thereby driving the traction member to pull the adjustable bending section to adjust the bending angle of the adjustable bending section; the outer peripheral wall of the outer shell is axially provided with an observation window, and the outer shell is provided with an indication scale on at least one side of the observation window, the sliding member comprises an identification member, and the axial movement of the identification member and the indication scale corresponding to the indication of the identification member can be observed through the observation window to visualize the bending angle.

[0007] 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 and the angle indexing portion cooperate to enable the driving member to rotate quantitatively. Because the proximal end of the sheath 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 assembly, thereby achieving precise control of the bending angle direction of the sheath assembly and avoiding excessive or insufficient rotation of the sheath assembly as a whole. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0009] Figure 1 1 is a schematic diagram of the three-dimensional structure of the adjustable bending sheath according to the first embodiment of the present invention;

[0010] Figure 2 yes Figure 1 A schematic diagram of a three-dimensional exploded view of the adjustable bending sheath;

[0011] Figure 3 yes Figure 1 A schematic diagram of an exploded perspective of the adjustable bending sheath from another perspective;

[0012] Figure 4 yes Figure 3 A schematic exploded perspective view of the adjustable bending sheath after removing the outer shell and the bending adjustment components;

[0013] Figure 5 yes Figure 2 A schematic diagram of the three-dimensional structure of the sheath tube assembly, inner core, sliding part and fixing part of the adjustable bending sheath;

[0014] Figure 6 yes Figure 2 Schematic diagram of the three-dimensional structure of the bending adjustment component and the traction component;

[0015] Figure 7 It is a cross-sectional schematic diagram of the sheath tube assembly of the adjustable bending sheath of the present invention;

[0016] Figure 8 yes Figure 4 Schematic diagram of the three-dimensional assembly structure of the fixing seat and the driving member;

[0017] Figure 9 yes Figure 8 A schematic diagram of the exploded three-dimensional structure of the fixing seat and the driving member;

[0018] Figure 10 yes Figure 9 Another perspective of the fixed seat and the three-dimensional structure exploded diagram of the driving member;

[0019] Figure 11 yes Figure 8 A schematic cross-sectional view of the middle fixing seat and the driving member;

[0020] Figure 12 yes Figure 2 Schematic diagram of further three-dimensional structural assembly of the adjustable bending sheath;

[0021] Figure 13 yes Figure 1 Frontal view of the adjustable curved sheath;

[0022] Figure 14 It is along Figure 13 A cross-sectional view along line XIV-XIV in FIG.

[0023] Figure 15 This is a schematic diagram of the three-dimensional structure of the adjustable bending sheath placed on the support platform according to the first embodiment of the present invention;

[0024] Figure 16 yes Figure 15 A schematic diagram of a three-dimensional exploded view of the adjustable bending sheath and the support platform;

[0025] Figure 17 1. It is a schematic diagram of the three-dimensional assembly structure of the fixing seat and the driving member of the adjustable bending sheath according to the second embodiment of the present invention;

[0026] Figure 18 yes Figure 17 A schematic diagram of the exploded three-dimensional structure of the fixing seat and the driving member;

[0027] Figure 19 yes Figure 18 Another perspective of the fixed seat and the three-dimensional structure exploded diagram of the driving member;

[0028] Figure 20 yes Figure 17 A schematic cross-sectional view of the middle fixing seat and the driving member;

[0029] Figure 21 1. It is a schematic diagram of the three-dimensional assembly structure of the fixing seat and the driving member of the adjustable bending sheath according to the third embodiment of the present invention;

[0030] Figure 22 yes Figure 21 A schematic diagram of the exploded three-dimensional structure of the fixing seat and the driving member;

[0031] Figure 23 yes Figure 18 Another perspective of the fixed seat and the three-dimensional structure exploded diagram of the driving member;

[0032] Figure 24 1 is a schematic exploded perspective view of the fixed base and the driving member of the adjustable bending sheath according to the fourth embodiment of the present invention;

[0033] Figure 25 yes Figure 24 A cross-sectional view of the assembled fixing seat and the driving member;

[0034] Figure 26 1 is a schematic exploded perspective view of the three-dimensional structure of the fixing base and the driving member of the adjustable bending sheath according to the fifth embodiment of the present invention. DETAILED DESCRIPTION

[0035] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0036] In addition, the following descriptions of the embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be implemented. Directional terms used in the present invention, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are used solely with reference to the directions in the accompanying drawings. Therefore, the use of directional terms is intended to better and more clearly illustrate and understand the present invention, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0037] Definition of Orientation: For clarity, the end closest to the operator during surgery is referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." This definition is for convenience only and should not be construed as limiting the present invention. "Axial" refers to the axial direction of the sheath.

[0038] First embodiment

[0039] See also Figures 1 to 3 The present invention provides an adjustable bending sheath 100, comprising a sheath assembly 20 and a handle assembly 40. The handle assembly 40 comprises 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 assembly 20 is provided with an adjustable bending section 21, and the proximal end of the sheath 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.

[0040] 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 to enable the driving member 45 to rotate quantitatively. Because the proximal end of the sheath 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 assembly 20, thereby achieving precise control of the bending angle direction of the sheath assembly 20 and preventing the sheath assembly 20 from rotating too much or too little as a whole.

[0041] It can be understood that the distal end of the sheath assembly 20 is provided with an adjustable bend section 21, and the bend adjustment 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 bend angle direction of the adjustable bend section 21. The proximal end of the sheath assembly 20 and the inner core 41 can be connected as a whole by, but not limited to, glue bonding, clamping or thermal insulation, and the sheath assembly 20 is coaxial with the inner core 41.

[0042] Please also refer to Figure 4-Figure 9The 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 a flexible material such as polytetrafluoroethylene (PTFE) and 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 be bent 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 not affecting the bending of the adjustable bend 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, thereby avoiding the influence on the bending of the adjustable bend section 21 while protecting the sheath assembly 20. 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 that extends completely from the proximal end along the axis of the sheath assembly 20 to the distal end. The distal end of the sheath assembly 20 is a smooth-surfaced guide slider 23, also known as a tip. A developing ring (not shown) is disposed adjacent to the tip. The developing ring includes, but is not limited to, a tantalum ring, etc., so that the developing device can accurately determine whether the distal end of the sheath assembly 20 has reached the specified position.

[0043] like Figure 5 and Figure 6 As shown, 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. Preferably, the anchoring ring 253 and the adjustable bend section 21 are coaxial. Specifically, the anchoring ring 253 can be heat-fused 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, heat 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 bend the adjustable bend section 21 or to straighten the adjustable bend section 21 after the traction force on the traction wire 251 is released. The traction wire 251 can be made of a metal material such as stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy, or a high-strength polymer material. The proximal end of the traction wire 251 can be connected to the bending adjustment component 43, so that the traction wire 251 can be used to pull the adjustable bend section 21 to bend or straighten it.

[0044] like Figure 4 and Figure 5 As shown, the inner core 41 includes a positioning portion 411 at the distal end, a connecting portion 415 at the proximal end, and a guide 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 on the distal end of the distal core tube 4110, and a second positioning ring 4114 fixedly sleeved on the proximal end of the distal core tube 4110. The outer circumferential wall of the first positioning ring 4112 is provided with at least one ring of retaining 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 the side facing the first positioning ring 4112. The outer circumferential 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 along its radial direction that connects to the through groove 4117. The guide portion 417 includes a sliding 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 sliding tube 4171. The inner lumen of the sliding tube 4171 communicates with the inner lumen of the distal core tube 4110. A guide groove 4175 is axially defined on the outer circumferential wall of the sliding tube 4171, communicating with the through groove 4117. The connecting portion 415 includes a proximal core tube 4150 connected to the baffle 4173 on the side facing away from the sliding tube 4171, and a plurality of clips 4153 disposed at the proximal end of the proximal core tube 4150. The inner lumen of the proximal core tube 4150 communicates axially with the inner lumen of the sliding tube 4170. The plurality of clips 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 external snap-in grooves 4155 . Specifically, the outer peripheral wall of the proximal core tube 4150 is axially provided with a plurality of snap-in grooves 4155 , and the plurality of snap-in grooves 4155 are arranged in a circle along the circumference of the proximal core tube 4150 .

[0045] like Figure 2-Figure 6 As shown, the bend adjustment component 43 includes a slider 430 and a bend adjustment member 437 mounted on the slider 430. The proximal end of the traction wire 251 is fixedly connected to the slider 430, which is axially slidably mounted on the guide portion 417 of the inner core 41. The slider 430 and the bend adjustment member 437 are threaded together. Rotating the bend adjustment member 437 drives the slider 430 to move axially along the inner core 41, thereby driving the traction wire 251 to pull the adjustable bend section 21 to bend or straighten.

[0046] Specifically, the slider 430 includes a slider 431 that is sleeved on the guide portion 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 an axial notch 4310, into which the guide portion 41 is received. The traction wire fixing block 435 is disposed on the inner wall of the notch 4310 and extends radially into the notch 4310. The traction wire fixing block 435 is used to securely connect the proximal end of the traction wire 251. It will be appreciated that the distal end of the traction wire fixing block 435 is provided with an axial fixing hole, into which the proximal end of the traction wire 251 is fixedly connected. The traction wire fixing block 435 and the slider 431 can be fixedly connected by means of a snap connection, a screw connection, or an adhesive connection, or can be integrally formed. Slider 431 has external threads 4312. The bending adjuster 437 has an inner cavity extending axially through its proximal and distal ends. The inner circumferential wall of the inner cavity of the bending adjuster 437 has internal threads 4371 that mate with the external threads 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, facilitating installation.

[0047] The housing 42 is composed of two removably joined frames 420. An observation window 421 is axially defined on the outer wall of at least one of the frames 420. An indicator scale 423 is provided on at least one side of the observation window 421. This indicator scale 423 indicates the position of an identification member 434, thereby measuring the axial sliding length of the slider 430. Specifically, by confirming the position of the identification member 434 corresponding to the indicator scale 423 through the observation window 421, the corresponding bending angle of the adjustable bending section 21 can be determined by reading the scale. A positioning recess 425 is provided at the intersection of the outer walls of the two frames 420.

[0048] Please also refer to Figures 8-11, 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 axially. 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 in 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 apart mounting holes 448, and each mounting hole 448 extends radially along 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 the present 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 located in the housing 462, and a steel ball 465. 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.

[0049] 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 integrally connected to the driving cylinder 453 via 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 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 circumference of the connecting cylinder 451. A plurality of indexing elements 471 are provided on the inner peripheral wall of the driving cylinder 453. The plurality of indexing elements 471 can be arranged at equal intervals or at unequal intervals. In this embodiment, the multiple indexing elements 471 are grooves spaced apart on the inner circumferential wall of the drive cylinder 453. When the driver 45 rotates relative to the fixed base 44, the elastic element 46, or the plunger elastic screw, sequentially engages the multiple grooves. The multiple grooves can be evenly spaced along the circumference of the drive cylinder 453, i.e., the multiple grooves are evenly spaced along the circumference of the drive cylinder 453. Each groove is compatible with the elastic element 46. In this embodiment, each groove is compatible with a steel ball 465, meaning that the steel ball 465 can be engaged or disengaged with the groove. If the number of indexing elements 471 provided on the inner circumferential wall of the drive cylinder 453 is N, the angle between two adjacent indexing elements 471 is 360° divided by N. The outer circumferential wall of the drive cylinder 453 is provided with angle markings along its circumference. In this embodiment, the outer circumferential wall of the drive cylinder 453 is marked with 0°, 90°, 180°, 270°, etc., to allow the user to determine the rotation angle of the driver 45 relative to the fixed base 44.

[0050] When assembling the fixing base 44 and the driver 45, first, the elastic element 46 is snapped into the corresponding mounting hole 448. Since the elastic element 46 and the mounting hole 448 form an interference fit, the elastic element 46 is prevented from disengaging from the mounting hole 448. Next, the connecting ring 441 of the fixing base 44 is rotatably received within the annular groove 454. The connecting tube 451 is provided with a connecting hole 442, exposing a retaining groove 4512. Specifically, the end of the connecting tube 451 is received within the inner cavity of the fixing ring 445, with a step 446 exposed outside the retaining groove 4512. The retaining spring 48 of the handle assembly 40 is then snapped into the retaining groove 4512, thereby locking the fixing base 44 and the driver 45 together. At this point, the fixing base 44 and the driver 45 can rotate relative to each other. That is, when the fixing base 44 is fixed, the driver 45 can rotate in both directions relative to the fixing base 44. However, the fixing base 44 and the driver 45 cannot move axially relative to each other. That is, the fixing base 44 and the driver 45 cannot move axially independently. 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 multiple 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, maintaining 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.

[0051] In other embodiments, the elastic element 46 can be disposed on the inner circumferential wall of the drive cylinder 453, and the plurality of indexing elements 471 can be disposed on the outer circumferential wall of the connecting ring 441. Specifically, the inner circumferential wall of the drive cylinder 453 is provided with at least two spaced-apart 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, each of which is provided with a plurality of spaced-apart grooves.

[0052] In other embodiments, the elastic element 46 is an elastic protrusion, which can be provided on the outer circumferential wall of the connecting ring 441 or the inner circumferential wall of the driving cylinder 453. The multiple indexing elements 471 are multiple grooves. Specifically, when two or more spaced elastic protrusions are provided on the outer circumferential wall of the connecting ring 441, the multiple grooves are provided on the inner circumferential 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 provided on the inner circumferential wall of the driving cylinder 453, the multiple grooves are provided on the outer circumferential 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 base 44, the elastic protrusions sequentially engage with the multiple grooves. When the driving member 45 is not rotating relative to the fixing base 44, the elastic protrusions engage with the corresponding grooves, achieving self-locking in position.

[0053] Please also refer to Figures 2 to 5The 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. The proximal end of the inner core 41 is penetrated by a connecting tube 451 and exposes a plurality of card connectors 4153. 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 cooperates with the fixing tube 4911. The sealing silicone 494 is mounted on the fixing member 491 through the sealing silicone support 496. The inner cavity of the adjustable curved 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 periphery of the delivery sheath to seal the delivery sheath to ensure that no blood leakage occurs during the operation.

[0054] Please also refer to Figures 1-6 and Figure 12-14To assemble the adjustable sheath 100, first, install the slider 430 on the inner core 41. Specifically, the slider 431 is sleeved onto 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 engaged with the positioning portion 411. The slider 431 can slide axially along the inner core 41 to drive the identification member 434 to slide axially, and the slider 431 is stopped between the second positioning ring 4114 and the blocking piece 4173. Next, the two frames 420 are fastened to the positioning portion 411 of the inner core 41, with the distal wall of each frame 420 snapping into the slot 4115 of the first positioning ring 4112, and the proximal wall of each frame 420 snapping into the positioning slot 4116 of the second positioning ring 4114. Finally, the bending adjustment member 437 is threadedly engaged with the slider 431 and mounted on the inner core 41. The retaining spring 4370 is engaged with the proximal end of the stopper 4173 of the inner core 41, so that the bending adjustment member 437 is stopped between the second positioning ring 4114 and the retaining spring, thereby limiting the axial movement of the bending adjustment member 437. Specifically, the bending adjustment member 437 can only rotate about the axis of the inner core 41. Then, the integral fixing base 44 and driving member 45 are installed to the proximal end of the inner core 41, so that the proximal end of the inner core 41 is passed through 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 multiple snap-in edges 4514 are respectively snap-fitted into the multiple snap-in grooves 4155 of the proximal core tube 4150. The multiple snap-in edges 4514 snap-fit ​​into the multiple snap-in 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 multiple snap-in members 4153 at the proximal end of the inner core 41 are inserted into the snap-in interface 4915 of the fixing tube 4911 and snap-fitted to 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.

[0055] like Figure 15 and Figure 16As shown, 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 fixing 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 shell 42 and the fixing 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 arranged 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 slot 303, and a first positioning fork 307 and a second positioning fork 308 spaced apart on the sliding bar 306. The first positioning fork 307 and the second positioning fork 308 are used to respectively secure the housing 42 and the fixing base 44. A locking member 309 passes through the support bar 302 and abuts against the sliding bar 306 in the guide slot 303, thereby positioning the bracket 305. The housing 42 and the fixing base 44 are secured to the bracket 305. Specifically, the first positioning fork 307 engages with the positioning recess 425 of the housing 42, and the second positioning fork 308 engages with the fixing surface 447 of the fixing base 44.

[0056] During interventional therapy, for ease of operation, the bracket 305 secures the fixing base 44 and the housing 42 so that the interface of the indicator scale 423 on the housing 42 always faces upward. When the sheath assembly 20 is inserted into the body, if the bending angle of the adjustable bend section 21 needs to be adjusted, the inner core 41 can be rotated 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 bend section 21.

[0057] During the rotation of the driving member 45, the elastic element 46 moves between the multiple indexing 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 providing multiple indexing elements 471 at equal intervals on the inner peripheral wall of the driving member 45, the direction of the sheath assembly 20 can be controlled in equal amounts and degrees, and the magnitude of the rotational force can be controlled by the elastic deformation of the elastic element 46. Therefore, during the use of the adjustable bending sheath 100, there is no need 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 housing 42 and the fixing seat 44 remain stationary in place. The adjustable bending sheath 100 is easy to use and operate, and the overall rotation amount of the sheath 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.

[0058] 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 .

[0059] Second embodiment

[0060] Please also refer to Figures 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 44a and the driving member 45a 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:

[0061] In the second embodiment, the connecting ring 441 includes a first sidewall 4410 facing the driver 45a. A connecting hole 442 is axially defined in the middle of the first sidewall 4410 and extends through the fixing seat 44a. The driver 45a includes a driving portion 453a connected to the connecting tube 451. The driving portion 453a is provided with a second sidewall 4531 around the connecting tube 451 and facing the first sidewall 4410. An elastic element 46 is provided on the first sidewall 4410, and a plurality of indexing elements 471 are provided on the second sidewall 4531. Specifically, the fixing seat 44a has a circular cylindrical structure. The first sidewall 4410 of the fixing seat 44a is provided with at least two spaced apart mounting holes 448, each of which extends axially along the connecting ring 441. Preferably, the first sidewall 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. 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 fixing seat 44a is also provided with a circular groove 4413. The purpose of providing the circular groove 4413 is to avoid airborne materials, reduce wall thickness, and facilitate mold opening processing. Of course, the fixing seat 44a may also not have the circular groove 4413. The connecting tube 451 is protruding from the middle part of the second side wall 4531 of the driving portion 453a, and the inner cavity of the connecting tube 451 is connected to the inner cavity of the driving portion 453a. A plurality of dividing elements 471 are provided on the second side wall 4531 along the circumference of the connecting tube 451. 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 fixing seat 44a, the elastic element 46, i.e., the plunger elastic screw, is sequentially inserted into the plurality of grooves. The multiple grooves can be evenly arranged along the circumference of the connecting tube 451, that is, the multiple grooves are evenly spaced along the circumference of the connecting tube 451. Each groove can be matched with the elastic element 46. In this embodiment, each groove is matched with the steel ball 465 of the elastic element 46, that is, the steel ball 465 can be engaged or disengaged with the groove. The usage and beneficial effects of the second embodiment are the same as those of the first embodiment and will not be repeated here.

[0062] In other embodiments, the elastic element 46 is disposed on the second sidewall 4531 of the drive cylinder 453a, and multiple indexing elements 471 are disposed on the first sidewall 4410 of the connecting ring 441. Specifically, the second sidewall 4531 is provided with at least two spaced-apart mounting holes along the circumference of the connecting cylinder 451, each of which is provided with an elastic element 46, which is a plunger elastic screw. Multiple indexing elements are disposed along the circumference of the first sidewall 4410, each of which is provided with a plurality of spaced-apart grooves.

[0063] In other embodiments, the elastic element 46 is an elastic protrusion, which can be provided on the first side wall 4410 of the connecting ring 441 or the second side wall 4531 of the driving cylinder 453a. The multiple indexing elements 471 are multiple grooves. Specifically, when two or more spaced elastic protrusions are provided on the first side wall 4410, multiple grooves are provided 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 provided on the second side wall 4531, multiple grooves are provided 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 sequentially engage with the multiple grooves. When the driving member 45a is not rotating relative to the fixing seat 44a, the elastic protrusions engage with the corresponding grooves, achieving self-locking in position.

[0064] Third embodiment

[0065] Please also refer to Figures 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 44b and the driving member 45b 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:

[0066] In the third embodiment, the elastic element 46a is a flexible ridge, and the multiple indexing elements 471a of the angle indexing portion 47a are multiple grooves arranged at intervals. When the driver 45b rotates relative to the fixed base 44b, the elastic ridges engage in sequence within the multiple grooves. When the driver 45b is not rotating relative to the fixed base 44b, the elastic ridges engage within the corresponding grooves. Specifically, the outer peripheral wall of the connecting ring 441 of the fixed base 44b is provided with multiple elastically deformable elastic elements 46a along the circumference of the connecting ring 441. The elastic elements 46a are inclined ridges that are flexible and can elastically deform when squeezed. Each elastic element 46a includes a connecting block 467 protruding from the outer peripheral wall of the connecting ring 441 and an elastic positioning strip 468 extending obliquely from the end of the connecting block 467. The elastic positioning strip 468 is inclined at an angle of 0 to 90 degrees relative to the corresponding connecting block 467. Preferably, the elastic positioning strips 468 are inclined at an angle of approximately 30 degrees relative to the corresponding connecting blocks 467. In this embodiment, multiple elastic elements 46a are evenly spaced along the circumference of the connecting ring 441, i.e., multiple elastic positioning strips 468 are evenly spaced along the circumference of the connecting ring 441. An annular groove 454 is formed between the drive cylinder 453 and the connecting cylinder 451. The indexing element 471a is a groove provided on the inner circumferential wall of the drive cylinder 453, facing the annular groove 454. In this embodiment, the inner circumferential wall of the drive cylinder 453 is provided with multiple grooves, which are arranged in a circle along the circumference of the drive cylinder 453, and each of the multiple grooves can mate with the ridges.

[0067] To assemble the fixed base 44b and the driver 45b, first, the connecting tube 451 of the driver 45b is rotatably received in the connecting hole 442 of the fixed base 44b, exposing the retaining groove 4512. Simultaneously, the connecting ring 441 is received in the annular groove 454, with the ridges of the fixed base 44b matching the grooves of the driver 45b. The retaining spring 48 of the handle assembly 40 is then engaged in the retaining groove 4512, thereby locking the fixed base 44b and the driver 45b together. At this point, the driver 45b can rotate unidirectionally relative to the fixed base 44b, but the fixed base 44b and the driver 45b cannot move axially relative to each other. The installation method of the fixed base 44b, the driver 45b, and the inner core 41 is the same as in the first embodiment and will not be repeated here.

[0068] The third embodiment of the adjustable sheath has similar usage and beneficial effects to the first embodiment, differing in that when the mounting base 44b is secured by the bracket 305 or by the operator's hand, the driver 45b rotates unidirectionally relative to the mounting base 44b, specifically, the driver 45b rotates along the angle of inclination of the ridge, causing the elastic positioning strips 468 to sequentially engage with the corresponding grooves. When the driver 45b is no longer required to rotate, the elastic positioning strips 468 engage with the grooves to achieve self-locking position. For example, when the sheath is rotated to a certain position, the multiple elastic positioning strips 468 engage with the multiple grooves, achieving a self-locking position and facilitating smooth surgical procedures.

[0069] During interventional procedures, the bracket 305 can be used to secure the fixing seat 44b. When the sheath assembly 20 is inserted into the body, if the bending angle of the adjustable bend section 21 needs to be adjusted, the inner core 41 can be rotated along the inclined direction of the ridges of the fixing seat 44b by rotating the driving member 45b, thereby adjusting the bending angle of the adjustable bend section 21. Due to the uniformly distributed ridges on the fixing seat 44b, the bending angle of the sheath assembly 20 can be precisely and uniformly controlled.

[0070] In other embodiments, the number of ridges on the outer circumferential wall of the connecting ring 441 may be two or more, and 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.

[0071] In other embodiments, the angle indexing portion may be a toothed ring disposed around the inner circumference 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 ridges.

[0072] Fourth embodiment

[0073] Please also refer to Figure 24 and Figure 25 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:

[0074] In the fourth embodiment, the fixing seat 44c includes a first side wall 4410 facing the driving member 45c. A plurality of elastic elements 46a are provided on the first side wall 4410 around the connecting hole 442. 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 evenly spaced. Each elastic element 46a is an inclined ridge, which is flexible and can undergo elastic deformation when squeezed. Each elastic element 46a includes a connecting block 467 protruding from 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 ranges from 0 degrees to 90 degrees; preferably, the inclination angle of the elastic positioning strip 468 relative to the connecting block 467 is approximately 30 degrees. The angle indexing portion 47b is a toothed ring disposed between the drive cylinder 453 and the connecting cylinder 451. The toothed ring is arranged around the circumference of the connecting cylinder 451. The toothed ring includes multiple toothed grooves, and the indexing elements 471b are toothed grooves. Each of the toothed grooves is capable of matching the ridges. Preferably, the multiple toothed grooves are evenly spaced along the circumference of the toothed ring. The usage and benefits of the fourth embodiment are the same as those of the third embodiment and are not further elaborated here.

[0075] 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 provided on the first side wall 4410 of the connecting ring 441 .

[0076] Fifth embodiment

[0077] See also Figure 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:

[0078] In the fifth embodiment, the side of the fixing ring 445 of the fixing seat 44d facing the driver 45d is provided with multiple indexing elements 471a around the connecting hole 442. These indexing elements 471a are multiple grooves arranged at intervals. The multiple grooves can be arranged at even or uneven intervals. Multiple elastic elements 46a are provided on the connecting plate between the end of the connecting tube 451 of the driver 45d and the driving tube 453. These elastic elements 46a are arranged in a circle along the circumference of the connecting tube 451. Each elastic element 46a is a flexible ridge, and the ridges mate with the multiple grooves.

[0079] 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

1. An adjustable bending sheath, characterized in that: The invention comprises a sheath assembly and a handle assembly, wherein the distal end of the sheath assembly is provided with an adjustable bending section, the handle assembly comprises an outer shell, a sliding member and a bending adjusting member sleeved on the sliding member, the sheath assembly comprises a traction member, and the traction member connects the adjustable bending section and the sliding member; the bending adjusting member is rotated to drive the sliding member to move axially, thereby driving the traction member to pull the adjustable bending section to adjust the bending angle of the adjustable bending section; an outer peripheral wall of the outer shell is axially provided with an observation window, and the outer shell is provided with an indication scale on at least one side of the observation window, and the sliding member comprises an identification member, through which the axial movement of the identification member and the indication scale corresponding to the indication of the identification member can be observed to visualize the bending angle.

2. The adjustable bending sheath according to claim 1, characterized in that: The outer shell and the bending adjusting member are connected in series along the axial direction of the sheath tube assembly, the sliding member includes a slider, the identification member is connected to the slider, the bending adjusting member can be rotatably mounted on the slider, and the proximal end of the traction member is connected to the slider; the bending adjusting member is rotated to drive the slider and the identification member to move axially synchronously.

3. The adjustable bending sheath according to claim 2, characterized in that: The identification piece consists of two detachable semicircular rings.

4. The adjustable bending sheath according to claim 3, characterized in that: The sliding member further includes a connecting rod provided between the identification member and the slider to axially connect the identification member and the slider in series, and one of the semicircular rings of the identification member is fixedly connected to the connecting rod.

5. The adjustable bending sheath according to any one of claims 1 to 4, characterized in that: The handle assembly includes an inner core, the proximal end of the sheath assembly is fixedly connected to the inner core, and the sliding member is axially slidably sleeved on the inner core; the bending adjustment member is rotated to drive the sliding member to move axially along the inner core.

6. The adjustable bending sheath according to claim 5, characterized in that: The handle assembly also includes a fixed seat and a driving member, the driving member is rotatably connected to the fixed seat, and the inner core is fixedly connected to the driving member; the driving member can rotate relative to the fixed seat to drive the inner core and the sheath assembly to rotate, thereby controlling the rotation amount of the sheath assembly.

7. The adjustable bending sheath according to claim 6, characterized in that: The outer shell, the bending adjusting member, the fixing seat and the driving member are connected in sequence along the axial direction of the inner core and are coaxially arranged with the sheath tube assembly.

8. The adjustable bending sheath according to claim 6, characterized in that: The fixing seat includes a connecting ring, which includes a connecting hole that axially penetrates the fixing seat. The driving member includes a connecting tube that is rotatably inserted into the connecting hole. The proximal end of the inner core is inserted into and fixedly connected to the connecting tube.

9. The adjustable bending sheath according to claim 8, characterized in that: The handle assembly also includes a fixing part, a sealing nut, a sealing silicone and a sealing silicone support. The proximal end of the inner core is passed through the connecting tube and then clamped into the fixing part. The sealing silicone is installed on the fixing part through the sealing silicone support, and the sealing nut is threadedly connected to the fixing part.

10. The adjustable bending sheath according to claim 6, characterized in that: A positioning recess is provided on the outer peripheral wall of the shell, and a fixing surface is provided on the outer peripheral wall of the fixing seat. When the adjustable bending sheath is supported on a support platform, the positioning recess and the fixing surface are respectively clamped on the support platform, and the observation window and the indicator scale are always facing upward.

Images