Controllable bending sheath
By designing a bend control mechanism and a pre-bend section structure for the controllable bending sheath, multi-directional adjustment is achieved, solving the problem of low operational precision of existing controllable bending sheaths in complex lesion sites, and improving applicability and safety.
Patent Information
- Application Number
- CN202310269048.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2023-03-17
- Publication Date
- 2025-11-28
- Estimated Expiration
- 2043-03-17
AI Technical Summary
Existing controllable curved sheaths are not precise enough for complex lesion sites, which can easily lead to damage to the vessel wall. Furthermore, existing fixed curved sheaths are not versatile enough to meet diverse needs.
A controllable bending sheath was designed, including a sheath assembly, a handle assembly, and a traction wire assembly. The bending control mechanism drives the traction wire to change the position of the bending section. Combined with the preset angle of the pre-bending section, multi-directional adjustment is achieved, avoiding damage to the blood vessel wall caused by sheath rotation.
It improves the applicability and operational precision of the controllable bending sheath, simplifies the operation process, reduces the risk of vascular wall damage and traction wire breakage, and makes it easier to reach the lesion site.
Smart Images
Figure CN116196527B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical devices, in particular to a controllable bent sheath tube. BACKGROUND
[0002] Cardiac intervention is the main treatment for heart disease, and its minimally invasive, precise treatment, fast postoperative recovery, simple operation and small psychological burden on patients have become the mainstream consensus.
[0003] In cardiac intervention, the sheath tube is an important tool for establishing a channel, transporting and recovering instruments, and is mainly divided into fixed bent sheaths and controllable bent sheaths, among which adjustable bent sheaths mainly include one-way bent sheaths and two-way bent sheaths. The fixed bent sheath is a sheath tube that is pre-processed to a certain angle according to the application scene in the production process. Due to individual differences and possible changes in the size of the physiological structure after the lesion, the applicability of the fixed bent sheath is low and it is difficult to meet diversified needs. The controllable bent sheath is a sheath tube that can be adjusted within a certain range by the operator in real time according to the application scene through the operation member during use. Compared with the fixed bent sheath, the controllable bent sheath has a wider range of applications because it can be adjusted in real time. However, for complex lesion sites, such as structural heart intervention, the existing one-way bent sheaths and two-way bent sheaths have limitations in reaching the target position. In practice, the operator often needs to rotate the sheath tube as a whole to reach the target position, and the precision is not high, which may cause damage to the blood vessel wall and complications. Therefore, there is an urgent need for a new controllable bent sheath tube that can solve the above problems. SUMMARY
[0004] The purpose of the present application is to provide a controllable bent sheath tube to solve the technical problems of low applicability of the fixed bent sheath and the need to rotate the sheath tube for complex lesion sites in the prior art to some extent.
[0005] In order to achieve the above-mentioned purpose, the present application provides the following technical solutions:
[0006] A controllable bent sheath tube, comprising a sheath tube assembly, a handle assembly and a traction wire assembly;
[0007] The sheath tube assembly comprises a bending adjustment section, a pre-bending section and a straight body section connected in sequence; the distal end of the straight body section is connected with the pre-bending section, and the proximal end of the straight body section is connected with the handle assembly; the pre-bending section is in a fixed curved form with a preset angle;
[0008] The handle assembly comprises a bending control mechanism;
[0009] The traction wire assembly is arranged inside the sheath tube assembly and extends to the inside of the handle assembly; the traction wire assembly comprises a plurality of traction wires arranged at intervals along the circumference of the sheath tube assembly, the distal end of each traction wire is fixedly connected with the bending adjustment section, and the proximal end of each traction wire is connected with the bending control mechanism; the bending control mechanism is configured to change the position of the bending adjustment section by driving the corresponding traction wire.
[0010] In any of the above technical solutions, optionally, the number of traction wires is four, which are a first traction wire, a second traction wire, a third traction wire and a fourth traction wire; the first traction wire, the third traction wire, the second traction wire and the fourth traction wire are arranged at intervals along the circumference of the sheath tube assembly in turn;
[0011] The bending control mechanism is configured to simultaneously drive the first traction wire and the second traction wire to move in opposite directions;
[0012] The bending control mechanism is configured to simultaneously drive the third traction wire and the fourth traction wire to move in opposite directions.
[0013] In any of the above technical solutions, optionally, the central axis plane of the pre-bending section is a first plane; the first traction wire and the second traction wire form a second plane; the third traction wire and the fourth traction wire form a third plane; the second plane is perpendicular to the third plane, and the included angle between the second plane and the third plane and the first plane is 40°-50°.
[0014] In any of the above technical solutions, optionally, the handle assembly further comprises a handle body; the handle body is sleeved on the straight body section;
[0015] The handle body is provided with a sliding mechanism connected with the bending control mechanism, and the sliding mechanism is configured to be driven by the bending control mechanism and reciprocally move along the axial direction of the straight body section;
[0016] The number of sliding mechanisms is two; the two sliding mechanisms are arranged in turn along the axial direction of the straight body section; the proximal end of the first traction wire and the proximal end of the second traction wire are respectively connected with a first sliding mechanism; the proximal end of the third traction wire and the proximal end of the fourth traction wire are respectively connected with a second sliding mechanism.
[0017] In any of the above technical solutions, optionally, the handle assembly further comprises a threaded sleeve sleeved on the handle body;
[0018] The sliding mechanism is arranged between the handle body and the threaded sleeve and is in threaded transmission connection with the threaded sleeve; the handle body is provided with a sliding groove connected with the sliding mechanism, and the sliding groove extends along the axial direction of the straight section;
[0019] The bending control mechanism is fixedly connected with the threaded sleeve.
[0020] In any of the above technical solutions, optionally, the number of the threaded sleeves is two, which are a first threaded sleeve and a second threaded sleeve;
[0021] The first sliding mechanism comprises a first sliding block and a second sliding block; the outer periphery of the first sliding block and the second sliding block is respectively provided with external threads, and the direction of the external threads of the first sliding block is opposite to that of the second sliding block;
[0022] The second sliding mechanism comprises a third sliding block and a fourth sliding block; the outer periphery of the third sliding block and the fourth sliding block is respectively provided with external threads, and the direction of the external threads of the third sliding block is opposite to that of the fourth sliding block; along the circumferential direction of the sheath assembly, the first sliding block, the third sliding block, the second sliding block and the fourth sliding block are sequentially and uniformly spaced;
[0023] The inner surface of the threaded sleeve is provided with bidirectional internal threads; the external threads of the first sliding block and the second sliding block are respectively engaged with the bidirectional internal threads of the first threaded sleeve; the external threads of the third sliding block and the fourth sliding block are respectively engaged with the bidirectional internal threads of the second threaded sleeve;
[0024] The proximal end of the first traction wire passes through the sliding block through hole of the first sliding block and is fixedly connected with a first traction wire fixed block; the proximal end of the second traction wire passes through the sliding block through hole of the second sliding block and is fixedly connected with a second traction wire fixed block;
[0025] The proximal end of the third traction wire passes through the sliding block through hole of the third sliding block and is fixedly connected with a third traction wire fixed block; the proximal end of the fourth traction wire passes through the sliding block through hole of the fourth sliding block and is fixedly connected with a fourth traction wire fixed block.
[0026] In any of the above technical solutions, optionally, the handle assembly further comprises a handle shell sleeved on the threaded sleeve;
[0027] The bending control mechanism comprises a first brake knob and a second brake knob; the first brake knob is sleeved on the first threaded sleeve, and the first brake knob is fixedly connected with the first threaded sleeve; the second brake knob is sleeved on the second threaded sleeve, and the second brake knob is fixedly connected with the second threaded sleeve;
[0028] The first brake knob and the second brake knob are respectively located at two ends of the handle shell in the axial direction of the sheath assembly.
[0029] In any of the above technical solutions, optionally, the handle shell comprises a front cover, a shell body and a rear cover arranged in sequence in the axial direction of the sheath assembly; wherein the shell body is located at the proximal end of the front cover;
[0030] The handle shell further comprises a nose end connected to the distal end of the front cover;
[0031] The nose end is provided with at least one nose end groove in the axial direction of the sheath assembly.
[0032] In any of the above technical solutions, optionally, a traction wire fixing ring is fixedly connected to the distal end of the bending adjustment section; the distal end of each traction wire is fixedly connected with the traction wire fixing ring; the traction wire fixing ring is coaxially arranged with the bending adjustment section;
[0033] The distal end of the straight section is fixedly connected with the proximal end of the pre-bending section, and the proximal end of the straight section is fixedly connected with the handle assembly;
[0034] The distal end of the pre-bending section is fixedly connected with the proximal end of the bending adjustment section;
[0035] The bending angle of the pre-bending section is 40°-50°.
[0036] In any of the above technical solutions, optionally, the bending angle of the pre-bending section is 45°;
[0037] The hardness of the straight section is greater than the hardness of the pre-bending section, and the hardness of the pre-bending section is greater than the hardness of the bending adjustment section.
[0038] In any of the above technical solutions, optionally, the sheath assembly comprises a sheath inner layer, a sheath intermediate layer and a sheath outer layer;
[0039] The traction wire is arranged between the sheath inner layer and the sheath intermediate layer, and / or the traction wire is arranged between the sheath outer layer and the sheath intermediate layer;
[0040] The sheath intermediate layer is a spring, a metal braid layer or a hypotube;
[0041] The sheath inner layer is a high-molecular film with low friction coefficient;
[0042] The material of the outer layer of the sheath is a polymer material;
[0043] The sheath assembly is provided with a developing member; the developing member is arranged at one or more of the bending adjusting section, the pre-bending section and the straight section.
[0044] The beneficial effects of the present application mainly include:
[0045] The controllable bending sheath provided by the present application can drive the traction wire assembly to change the position of the bending adjusting section of the sheath assembly through the bending control mechanism of the handle assembly, thereby improving the applicability of the controllable bending sheath. The pre-bending section is in a fixed bending mode at a preset angle, so that the controllable bending sheath can easily reach the vicinity of the lesion site. The position of the bending adjusting section is adjusted by the plurality of traction wires, so that multi-directional bending can be achieved without rotating the controllable bending sheath, the bending adjusting section can be adjusted in all directions, the lesion site can be easily reached, and the operation of the controllable bending sheath is simplified. The controllable bending sheath uses the multi-directional bending adjusting section combined with the pre-bending section structure, which improves the operation accuracy to some extent and can effectively avoid the risk of blood vessel wall damage or even traction wire breakage caused by rotating the sheath.
[0046] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the following preferred embodiments are described in detail below, and the accompanying drawings are described as follows. BRIEF DESCRIPTION OF DRAWINGS
[0047] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.
[0048] Figure 1 The structure diagram of the controllable bending sheath provided by the present application is shown in the figure.
[0049] Figure 2 The structure diagram of the controllable bending sheath provided by the present application is shown in the figure. Figure 1 The enlarged view of the controllable bending sheath shown in the figure.
[0050] Figure 3 The exploded view of the controllable bending sheath provided by the present application is shown in the figure.
[0051] Figure 4 The structure diagram of the multi-directional bending of the controllable bending sheath provided by the present application is shown in the figure.
[0052] Figure 5 The structure diagram of the controllable bending sheath provided by the present application is shown in the figure.
[0053] Figure 6 A cross-sectional schematic diagram of the sheath assembly provided for an embodiment of the present invention (the drawing wire is shown in the figure);
[0054] Figure 7 This is a schematic diagram of the assembly of the handle body and the traction wire provided in an embodiment of the present invention;
[0055] Figure 8 This is a schematic diagram of the assembly of the handle body and the traction wire from another perspective, provided in an embodiment of the present invention.
[0056] Figure 9 This is a schematic diagram showing the connection relationship between the two handle bodies and the threaded sleeve provided in an embodiment of the present invention;
[0057] Figure 10 This is a schematic diagram of the handle body provided in an embodiment of the present invention;
[0058] Figure 11 This is a schematic diagram of the structure of the first sliding block provided in an embodiment of the present invention;
[0059] Figure 12 This is a schematic diagram of the structure of the second sliding block provided in an embodiment of the present invention;
[0060] Figure 13 This is a schematic diagram of the second sliding block from another perspective, provided in an embodiment of the present invention.
[0061] Figure 14 This is a schematic diagram of the structure of the threaded sleeve provided in an embodiment of the present invention;
[0062] Figure 15 This is a schematic diagram of the threaded sleeve provided in an embodiment of the present invention from another perspective.
[0063] Figure 16 This is a schematic diagram of the brake knob provided in an embodiment of the present invention;
[0064] Figure 17 This is a schematic diagram of the structure of the front cover provided in an embodiment of the present invention;
[0065] Figure 18 A schematic diagram showing the distribution of the developing elements provided in an embodiment of the present invention;
[0066] Figure 19 A schematic diagram of the controllable bending sheath at the left atrial appendage orifice provided in an embodiment of the present invention;
[0067] Figure 20 for Figure 19 The FF-direction cross-sectional view of the controllable bending sheath shown.
[0068] Icons: 11 - First plane; 12 - Second plane; 13 - Third plane;
[0069] 100 - sheath assembly; 101 - pre-bent section; 102 - straight section; 103 - straight section; 104 - pull wire fixation ring; 105 - inner sheath layer; 106 - middle sheath layer; 107 - outer sheath layer; 108 - pull wire protection sleeve; 111 - first visualization ring; 112 - second visualization ring; 113 - third visualization ring; 114 - fourth visualization ring;
[0070] 200 - handle assembly; 201 - housing body; 202 - first brake knob; 2021 - knob groove; 2022 - silica gel; 203 - second brake knob; 204 - front cover; 2041 - front cover groove; 205 - nose end; 2051 - nose end groove; 206 - rear cover; 207 - first threaded sleeve; 2071 - first sliding block; 2072 - second sliding block; 2073 - first pull wire fixation block; 2074 - second pull wire fixation block; 2075 - sliding block through hole; 2077 - sliding block boss; 2078 - sleeve protrusion; 208 - second threaded sleeve; 2081 - third sliding block; 2082 - fourth sliding block; 2083 - third pull wire fixation block; 2084 - fourth pull wire fixation block; 209 - handle body; 2091 - sliding groove; 2092 - handle body boss; 210 - second handle body; 211 - hemostatic valve; 212 - connecting tube; 213 - three-way valve;
[0071] 300 - pull wire assembly; 301 - first pull wire; 302 - second pull wire; 303 - third pull wire; 304 - fourth pull wire;
[0072] 401 - right atrium; 402 - fossa ovalis; 403 - left atrium; 404 - left atrial appendage. DETAILED DESCRIPTION
[0073] Therefore, the following detailed description of the embodiments of the application provided in the accompanying drawings is not intended to limit the scope of the application claimed, but merely represents selected embodiments of the application. Based on the embodiments in the application, all other embodiments obtained by those of ordinary skill in the art without creative labor, fall within the scope of protection of the application.
[0074] Therefore, the following detailed description of the embodiments of the application provided in the accompanying drawings is not intended to limit the scope of the application claimed, but merely represents selected embodiments of the application. Based on the embodiments in the application, all other embodiments obtained by those of ordinary skill in the art without creative labor, fall within the scope of protection of the application.
[0075] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.
[0076] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. In addition, the terms "first," "second," "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.
[0077] Furthermore, terms such as "horizontal," "vertical," and "sag" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.
[0078] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.
[0079] The following detailed description of some embodiments of the present invention is provided in conjunction with the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.
[0080] Example
[0081] This embodiment provides a controllable bending sheath; please refer to... Figures 1 to 20 , Figure 1 This is a schematic diagram of the controllable bending sheath provided in this embodiment. Figure 2 for Figure 1 The enlarged view of region A of the controllable bending sheath shown is shown below. Figure 3 This is an exploded view of the controllable bending sheath provided in this embodiment. Figure 4 This is a schematic diagram of the controllable bending sheath multi-directional bending structure provided in this embodiment, showing the four bending directions. Figure 5The structure schematic diagram of the handle shell of the hidden part of the controllable bent sheath provided in the embodiment is shown in the figure, which hides half of the front cover 204, the shell body 201 and the rear cover 206 respectively; Figure 6 The cross-sectional schematic diagram of the sheath assembly provided in the embodiment is shown in the figure, which shows the pull wire; Figure 7 and Figure 8 The assembly schematic diagram of the handle body and the pull wire from two perspectives provided in the embodiment is shown in the figure; Figure 9 The schematic diagram of the connection relationship between the two handle bodies and the threaded sleeve provided in the embodiment is shown in the figure; Figure 10 The structure schematic diagram of the handle body provided in the embodiment is shown in the figure; Figure 11 The structure schematic diagram of the outer peripheral surface direction of the first sliding block provided in the embodiment is shown in the figure, Figure 12 The structure schematic diagram of the outer peripheral surface direction of the second sliding block provided in the embodiment is shown in the figure, Figure 13 The structure schematic diagram of the inner surface direction of the second sliding block provided in the embodiment is shown in the figure, and the inner surface structure of the first sliding block is the same as that of the second sliding block; Figure 14 The structure schematic diagram of the inner surface direction of the threaded sleeve provided in the embodiment is shown in the figure, Figure 15 The structure schematic diagram of the outer peripheral surface direction of the threaded sleeve provided in the embodiment is shown in the figure; Figure 16 The structure schematic diagram of the brake knob provided in the embodiment is shown in the figure; Figure 17 The structure schematic diagram of half of the front cover provided in the embodiment is shown in the figure; Figure 18 The distribution schematic diagram of the developing member provided in the embodiment is shown in the figure; Figure 19 The schematic diagram of the controllable bent sheath at the ostium of the left atrial appendage provided in the embodiment is shown in the figure; Figure 20 The F-F cross-sectional view of the controllable bent sheath shown in the figure. Figure 19 The F-F cross-sectional view of the controllable bent sheath shown in the figure.
[0082] The controllable bent sheath provided in the embodiment is used for interventional therapy, for example, for cardiac electrophysiology intervention, structural heart intervention, etc.
[0083] Referring to Figures 1 to 20 As shown in the figure, the controllable bent sheath comprises a sheath assembly 100, a handle assembly 200 and a pull wire assembly 300; the pull wire assembly 300 connects the sheath assembly 100 and the handle assembly 200.
[0084] The sheath assembly 100 comprises a bending adjustment section 101, a pre-bending section 102 and a straight section 103 connected in sequence; the distal end of the straight section 103 is connected with the pre-bending section 102, and the proximal end of the straight section 103 is connected with the handle assembly 200; optionally, the pre-bending section 102 is in a fixed bending form with a preset angle. In this embodiment, the pre-bending section 102 can be bent in different directions. Optionally, the bending angle of the pre-bending section 102 is 40°-50°, for example, the bending angle of the pre-bending section 102 is 40°, 50° or any angle within the range of 40°-50°. Optionally, the bending angle of the pre-bending section 102 is 45°. Wherein, the bending angle of the pre-bending section 102 can be understood as the included angle between the central axis plane of the pre-bending section 102 and the extension line of the straight section 103.
[0085] The handle assembly 200 comprises a bending control mechanism.
[0086] The traction wire assembly 300 is arranged inside the sheath assembly 100 and extends to the inside of the handle assembly 200; the distal end of the traction wire assembly 300 is connected with the bending adjustment section 101, and the proximal end of the traction wire assembly 300 is connected with the bending control mechanism. Optionally, the traction wire assembly 300 comprises a plurality of traction wires arranged in a circumferential direction of the sheath assembly 100; the distal end of each traction wire is fixedly connected with the bending adjustment section 101, and the proximal end of each traction wire is connected with the bending control mechanism.
[0087] The bending control mechanism is configured to change the position of the bending adjustment section 101 by driving the corresponding traction wire. Through the bending control mechanism, the position of the bending adjustment section 101 relative to the pre-bending section 102 is adjusted.
[0088] In this embodiment, the controllable bending sheath can drive the traction wire assembly 300 to change the position of the bending adjustment section 101 of the sheath assembly 100 through the bending control mechanism of the handle assembly 200, thereby improving the applicability of the controllable bending sheath; the pre-bending section 102 is in a fixed bending form with a preset angle, so that the controllable bending sheath can more easily reach the vicinity of the lesion site; the position of the bending adjustment section 101 is adjusted by the plurality of traction wires, so that multi-directional bending can be achieved without rotating the controllable bending sheath, the bending adjustment section 101 can be omnidirectionally adjusted, the lesion site can be more easily reached, and the operation of the controllable bending sheath is simplified. The controllable bending sheath adopts the structure of multi-directional adjustment of the bending adjustment section 101 combined with the pre-bending section 102, which improves the operation accuracy to some extent and can effectively avoid the risk of blood vessel wall damage or even traction wire breakage caused by rotating the sheath.
[0089] In the field of cardiac electrophysiological intervention, the controllable bending sheath currently mainly used has a one-way bending, a two-way bending or even a multi-way bending sheath. However, in the field of structural heart intervention, the currently commercialized sheath is mainly a fixed bending sheath, and a few adjustable bending sheaths. The fixed bending sheath is obviously difficult to meet the changing heart structure in the structural heart intervention. The adjustable bending sheath is mainly a one-way bending sheath and a two-way bending sheath, which also has limitations in the structural heart intervention, and the position that can be reached is limited. In actual application, the operator often needs to rotate the one-way bending sheath or the two-way bending sheath as a whole in order to reach the target position, which is likely to cause damage to the blood vessel wall and even complications. At present, the adjustable bending sheath also appears to use a two-section adjustable bending, but there is still a significant defect because the two-section adjustable bending and the fixed pre-bending cannot be arranged on the sheath at the same time. In this way, the two-section adjustable bending segment is arranged in the shape of the pre-bending, which means that the two-section adjustable bending can only be adjusted in a single direction. If the reverse bending control is performed, the precision is difficult to control, and even the risk of breaking the traction wire is caused.
[0090] The controllable bending sheath in the embodiment can be more easily reached near the lesion site through the cooperation of the pre-bending segment 102 and the bending adjustment segment 101, that is, through the fixed bending segment and the single-section adjustable bending segment, and then the target lesion site can be more easily reached by adjusting the position of the bending adjustment segment 101. For example, the controllable bending sheath reaches the right atrium through the inferior vena cava, and the angle of the pre-bending segment 102 can find the position of the fossa ovalis (i.e., near the lesion site) without the need to control the bending control mechanism, and then reaches the left atrium, and then finds the target position (i.e., the target lesion site) through the multi-way adjustment of the bending adjustment segment 101.
[0091] Referring to Figures 1 to 8 In the optional solution of the embodiment, the number of traction wires is four, which are a first traction wire 301, a second traction wire 302, a third traction wire 303 and a fourth traction wire 304. The first traction wire 301, the third traction wire 303, the second traction wire 302 and the fourth traction wire 304 are sequentially and uniformly spaced along the circumference of the sheath assembly 100. That is, the spacing between the four traction wires along the circumference of the sheath assembly 100 is 90°. Alternatively, the first traction wire 301, the second traction wire 302, the third traction wire 303 and the fourth traction wire 304 are parallel to each other and do not interfere with each other.
[0092] The bending control mechanism is configured to simultaneously drive the first traction wire 301 and the second traction wire 302 to move in opposite directions.
[0093] The bending control mechanism is configured to drive the third traction wire 303 and the fourth traction wire 304 to move in opposite directions at the same time. Through the first traction wire 301, the second traction wire 302, the third traction wire 303, and the fourth traction wire 304, the bending control segment 101 of the controllable bending sheath can be bent in all directions under the driving of the four traction wires, that is, the universal bending control, and the bending control segment 101 is more flexible and controllable, and can reach positions that the bidirectional bending sheath cannot reach.
[0094] Optionally, the central axis plane of the pre-bending segment 102 is the first plane 11, which can be understood as the central axis plane of the sheath assembly 100. Optionally, the first plane 11 is the central axis plane of the controllable bending sheath.
[0095] The first traction wire 301 and the second traction wire 302 form a second plane 12, and the third traction wire 303 and the fourth traction wire 304 form a third plane 13. The second plane 12 is perpendicular to the third plane 13, and the included angles between the second plane 12 and the first plane 11 and between the third plane 13 and the first plane 11 are 40°-50°. With such a design, the controllable bending sheath with four-way bending control can be more easily bent in all directions, and the bending control segment 101 is more flexible and controllable, and can more easily reach the target position.
[0096] Optionally, the included angles between the second plane 12 and the first plane 11 and between the third plane 13 and the first plane 11 are, for example, 40°, 43°, 45°, 50°, or any angle value within the range of 40°-50°.
[0097] Referring to Figures 7 to 10 In the optional scheme of the embodiment, the handle assembly 200 further includes a handle body 209, and the handle body 209 is sleeved on the straight segment 103. For example, the straight segment 103 is arranged in the handle body 209.
[0098] The handle body 209 is provided with a sliding mechanism connected with the bending control mechanism, and the sliding mechanism is configured to be driven by the bending control mechanism and reciprocally move along the axial direction of the straight segment 103.
[0099] The number of the sliding mechanisms is two, and the two sliding mechanisms are sequentially arranged along the axial direction of the straight segment 103. The proximal end of the first traction wire 301 and the proximal end of the second traction wire 302 are respectively connected with the first sliding mechanism, and the proximal end of the third traction wire 303 and the proximal end of the fourth traction wire 304 are respectively connected with the second sliding mechanism. Through two traction wires and one sliding mechanism, that is, one sliding mechanism controls two corresponding traction wires, the accuracy of the controllable bending sheath reaching the target position can be effectively improved. Through two sliding mechanisms controlling four corresponding traction wires, the universal adjustment function of the controllable bending sheath can be realized, and the controllable bending sheath can also reach the target position without rotating the sheath.
[0100] Referring toFigures 7 to 10 As shown, in an optional embodiment of the present application, the handle assembly 200 further comprises a threaded sleeve 206 sleeved on the handle body 209.
[0101] A sliding mechanism is arranged between the handle body 209 and the threaded sleeve 206, and the sliding mechanism is in threaded transmission connection with the threaded sleeve 206, that is, the sliding mechanism is provided with external threads on the outer circumferential surface thereof away from the handle body 209, as shown in Figure 11 and Figure 12 As shown, the inner surface of the threaded sleeve 206 close to the sliding mechanism is provided with internal threads, as shown in Figure 14 Only half of the threaded sleeve 206 is shown in the figure.
[0102] The handle body 209 is provided with a sliding groove 2091 connected with the sliding mechanism, and the sliding groove 2091 extends along the axial direction of the straight body section 103; the sliding groove 2091 is used to make the sliding mechanism move more stably and more accurately along the axial direction of the straight body section 103.
[0103] Optionally, the bending control mechanism is fixedly connected with the threaded sleeve 206. The bending control mechanism is fixedly connected with the threaded sleeve 206 to drive the bending control mechanism and the threaded sleeve 206 to move synchronously, thereby facilitating the control of the sliding mechanism to move along the axial direction of the straight body section 103.
[0104] As shown in Figures 1 to 13 In an optional embodiment of the present application, the number of threaded sleeves is two, which are a first threaded sleeve 207 and a second threaded sleeve 208. The first sliding mechanism is arranged between the handle body 209 and the first threaded sleeve 207, and the second sliding mechanism is arranged between the handle body 209 and the second threaded sleeve 208.
[0105] The first sliding mechanism comprises a first sliding block 2071 and a second sliding block 2072; the outer circumferences of the first sliding block 2071 and the second sliding block 2072 are respectively provided with external threads, and the direction of the external threads of the first sliding block 2071 is opposite to that of the second sliding block 2072; for example, the outer circumference of the first sliding block 2071 is provided with left-handed threads, and the outer circumference of the second sliding block 2072 is provided with right-handed threads, and vice versa.
[0106] The second sliding mechanism comprises a third sliding block 2081 and a fourth sliding block 2082; the outer circumferences of the third sliding block 2081 and the fourth sliding block 2082 are respectively provided with external threads, and the direction of the external threads of the third sliding block 2081 is opposite to that of the fourth sliding block 2082; along the circumferential direction of the sheath assembly 100, the first sliding block 2071, the third sliding block 2081, the second sliding block 2072 and the fourth sliding block 2082 are sequentially and uniformly spaced.
[0107] The inner surface of the threaded sleeve is provided with bidirectional internal threads; the external threads of the first sliding block 2071 and the external threads of the second sliding block 2072 are respectively engaged with the bidirectional internal threads of the first threaded sleeve 207.
[0108] The distal ends of the first traction wire 301 and the second traction wire 302 are respectively fixedly connected with the bending section 101; the proximal end of the first traction wire 301 passes through the sliding block through hole 2075 of the first sliding block 2071 and is fixedly connected with the first traction wire fixed block 2073; the proximal end of the second traction wire 302 passes through the sliding block through hole 2075 of the second sliding block 2072 and is fixedly connected with the second traction wire fixed block 2074. Optionally, the first traction wire 301 is parallel to the second traction wire 302, and the first traction wire 301 and the second traction wire 302 are circumferentially distributed on the sheath assembly 100. That is, the included angle between the first traction wire 301 and the second traction wire 302 in the circumferential direction of the sheath assembly 100 is 180°. By parallelizing the first traction wire 301 and the second traction wire 302 and circumferentially distributing the first traction wire 301 and the second traction wire 302 on the sheath assembly 100, when the threaded sleeve rotates, the first sliding block 2071 and the second sliding block 2072 move in opposite directions, thereby causing one of the first traction wire 301 and the second traction wire 302 to be tightly stretched and the other to be relaxed, and the sheath assembly 100 bends due to the tension of the two traction wires, thereby facilitating more accurate control of the movement of the bending section 101.
[0109] The distal ends of the third traction wire 303 and the fourth traction wire 304 are respectively fixedly connected with the bending section 101; the proximal end of the third traction wire 303 passes through the sliding block through hole of the third sliding block 2081 and is fixedly connected with the third traction wire fixed block 2083; the proximal end of the fourth traction wire 304 passes through the sliding block through hole of the fourth sliding block 2082 and is fixedly connected with the fourth traction wire fixed block 2084. Optionally, the third traction wire 303 is parallel to the fourth traction wire 304, and the third traction wire 303 and the fourth traction wire 304 are circumferentially distributed on the sheath assembly 100. That is, the included angle between the third traction wire 303 and the fourth traction wire 304 in the circumferential direction of the sheath assembly 100 is 180°. By parallelizing the third traction wire 303 and the fourth traction wire 304 and circumferentially distributing the third traction wire 303 and the fourth traction wire 304 on the sheath assembly 100, when the threaded sleeve rotates, the third sliding block 2081 and the fourth sliding block 2082 move in opposite directions, thereby causing one of the third traction wire 303 and the fourth traction wire 304 to be tightly stretched and the other to be relaxed, and the sheath assembly 100 bends due to the tension of the two traction wires, thereby facilitating more accurate control of the movement of the bending section 101.
[0110] In this embodiment, the number of handle bodies 209 can be one, for example, the handle body 209 is provided with four sliding grooves corresponding to the first sliding block 2071, the second sliding block 2072, the third sliding block 2081 and the fourth sliding block 2082 respectively.
[0111] In this embodiment, the number of handle bodies 209 can also be two, and each handle body 209 has two sliding grooves 2091; the two sliding grooves 2091 are parallel and opposite. For example, as shown in Figures 7 to 10 , in order to facilitate the display, the first handle body adopts the handle body 209, and the second handle body adopts the second handle body 210, the handle body 209 corresponds to the first sliding block 2071 and the second sliding block 2072 respectively, and the second handle body 210 corresponds to the third sliding block 2081 and the fourth sliding block 2082 respectively.
[0112] Optionally, as shown in Figures 7 to 10 , the proximal end of the first traction wire 301 passes through the sliding block through hole 2075 of the first sliding block 2071 of the first handle body 209 and is fixedly connected with the first traction wire fixing block 2073; the proximal end of the second traction wire 302 passes through the sliding block through hole 2075 of the second sliding block 2072 of the first handle body 209 and is fixedly connected with the second traction wire fixing block 2074. The proximal end of the third traction wire 303 passes through the sliding block through hole 2075 of the third sliding block 2081 of the second handle body 210 and is fixedly connected with the third traction wire fixing block 2083; the proximal end of the fourth traction wire 304 passes through the sliding block through hole 2075 of the fourth sliding block 2082 of the second handle body 210 and is fixedly connected with the fourth traction wire fixing block 2084.
[0113] Referring to Figure 13 , the first sliding block 2071, the second sliding block 2072, the third sliding block 2081 and the fourth sliding block 2082 are all provided with sliding block bosses 2077 matched with the sliding grooves 2091, the sliding block bosses 2077 are embedded in the sliding grooves 2091 and can reciprocate along the sliding grooves 2091.
[0114] Referring to Figures 1 to 5 , in the optional scheme of the present embodiment, the handle assembly 200 further comprises a handle shell sleeved on the threaded sleeve. Through the handle shell, the threaded sleeve, the sliding mechanism and the like arranged therein are better protected, and the appearance of the controllable bending sheath tube can also be improved to a certain extent.
[0115] Optionally, the bending control mechanism comprises a first brake knob 202 and a second brake knob 203; the first brake knob 202 is sleeved on the first threaded sleeve 207, and the first brake knob 202 is fixedly connected with the first threaded sleeve 207; the second brake knob 203 is sleeved on the second threaded sleeve 208, and the second brake knob 203 is fixedly connected with the second threaded sleeve 208. Through the first brake knob 202 and the second brake knob 203, the operation of the traction wire assembly 300 can be better controlled, so as to adjust the position of the bending section 101 relative to the pre-bending section 102.
[0116] Optionally, along the axial direction of the sheath assembly 100, the first brake knob 202 and the second brake knob 203 are respectively located at both ends of the handle shell. By locating the first brake knob 202 and the second brake knob 203 at both ends of the handle shell, the first brake knob 202 and the second brake knob 203 can be more conveniently operated.
[0117] Optionally, the proximal end of the straight section 103 is fixedly connected with a hemostatic valve 211, and the hemostatic valve 211 is communicated with a three-way valve 213 through a connecting pipe 212. Optionally, the straight section 103 and the hemostatic valve 211 are fixed by heat melting or gluing, and the hemostatic valve 211 and the three-way valve 213 are glued and fixed at both ends of the connecting pipe 212. Optionally, the hemostatic valve 211 and the three-way valve 213 are made of ABS or ABS+PC injection molding, so that the hemostatic valve 211 and the three-way valve 213 have better precision, strength and stability, and can meet the assembly and use requirements. By connecting the hemostatic valve 211 with the three-way valve 213 through the connecting pipe 212, blood in the blood vessel can be prevented from overflowing out of the body, blood loss can be reduced, the operation difficulty of the surgery can be reduced, and the gas outside the body can be prevented from entering the blood vessel.
[0118] Optionally, the connecting pipe 212 is formed by TPE extrusion pipe.
[0119] Referring to Figures 1 to 5 Optionally, in the alternative of the embodiment, the handle shell comprises a front cover 204, a shell body 201 and a rear cover 206 which are sequentially arranged along the axial direction of the sheath assembly 100; the shell body 201 is located at the proximal end of the front cover 204, and the shell body 201 is located at the distal end of the rear cover 206; the front cover 204, the shell body 201 and the rear cover 206 are sleeved on the sheath assembly 100. Optionally, the shell body 201 is sleeved on the threaded sleeve.
[0120] Optionally, as Figure 1 shown, the first brake knob 202 is arranged between the front cover 204 and the shell body 201, and the second brake knob 203 is arranged between the rear cover 206 and the shell body 201.
[0121] Optionally, the handle body 209 is provided with a square-round handle body boss 2092; the front cover 204 is provided with a front cover groove 2041 which is clamped with the handle body boss 2092; through the front cover groove 2041 and the handle body boss 2092, not only the axial position can be fixed, but also the rotation of the first brake knob 202 can be prevented from driving the handle body 209 to rotate to affect the bending effect of the sheath tube assembly 100.
[0122] Referring to Figures 1 to 5 Optionally, the hemostasis valve 211 is fixedly connected to the inside of the rear cover 206, and the three-way valve 213 is arranged outside the rear cover 206.
[0123] Referring to Figures 1 to 5 Optionally, in the optional scheme of the embodiment, the handle shell further comprises a nose end 205 which is connected to the distal end of the front cover 204; the nose end 205 is sleeved on the sheath tube assembly 100. Through the nose end 205, the stress generated at the connection between the sheath tube assembly 100 and the handle assembly 200 during bending can be reduced, and the bending of the sheath tube assembly 100 can be reduced or avoided.
[0124] Optionally, the nose end 205 is provided with at least one nose end groove 2051 along the axial direction of the sheath tube assembly 100; through the nose end groove 2051, the flexibility of the nose end 205 can be better improved, so as to disperse the stress generated at the connection between the sheath tube assembly 100 and the handle assembly 200, and play a stress dispersion role.
[0125] Optionally, the material of the nose end 205 is a high polymer material with good elasticity and low hardness, such as TPU, Pebax, nylon or silica gel.
[0126] Optionally, the nose end 205 is formed by injection molding.
[0127] Optionally, the outer periphery of the threaded sleeve is provided with a sleeve protrusion 2078, and the brake knob is provided with a knob groove 2021 which is matched with the sleeve protrusion 2078; through the sleeve protrusion 2078 and the knob groove 2021, the rotation between the brake knob and the threaded sleeve can be prevented, and the firmness of the connection between the brake knob and the threaded sleeve can be improved.
[0128] Optionally, the brake knob is made of plastic material, and the brake knob is sleeved with silica gel 2022 or rubber material. Through the silica gel 2022 or rubber material, the anti-skid performance of the brake knob can be improved. When the brake knob is rotated, the hardness of the plastic material is sufficient to drive the threaded sleeve to rotate.
[0129] Referring to Figures 1 to 3As shown, in the optional solution of the embodiment, the distal end of the bending adjustment section 101 is fixedly connected with a traction wire fixing ring 104.
[0130] Optionally, the distal end of each traction wire is fixedly connected with the traction wire fixing ring 104; optionally, the distal end of the traction wire is fixed on the traction wire fixing ring 104 by welding or winding. The traction wire is fixed at the distal end of the sheath assembly 100 through the traction wire fixing ring 104, so as to facilitate the adjustment of the position of the bending adjustment section 101.
[0131] Optionally, the traction wire fixing ring 104 is coaxially arranged with the bending adjustment section 101.
[0132] Optionally, when the number of traction wires is multiple, the multiple traction wires are parallel to each other, and the multiple traction wires are uniformly distributed along the circumference of the traction wire fixing ring 104. In the embodiment, the distal end of the traction wire is fixedly connected with the distal end of the bending adjustment section 101 through the traction wire fixing ring 104, and the traction wire extends in parallel in the sheath assembly 100 until it comes out at the proximal end of the straight section 103.
[0133] Optionally, the traction wire fixing ring 104 is made of stainless steel or nickel-titanium, and in the embodiment, the traction wire fixing ring 104 can also be made of other materials that can meet the requirements of fixing the traction wire.
[0134] In the optional solution of the embodiment, the distal end of the straight section 103 is fixedly connected with the proximal end of the pre-bending section 102, for example, by fusion or welding, or the distal end of the straight section 103 is fixedly connected with the proximal end of the pre-bending section 102 in other ways.
[0135] In the optional solution of the embodiment, the proximal end of the straight section 103 is fixedly connected with the handle assembly 200; for example, the proximal end of the straight section 103 is fixedly connected with the handle assembly 200 by welding, bonding or other ways.
[0136] Optionally, the distal end of the pre-bending section 102 is fixedly connected with the proximal end of the bending adjustment section 101, for example, by fusion or welding; or the distal end of the pre-bending section 102 is fixedly connected with the proximal end of the bending adjustment section 101 in other ways.
[0137] Optionally, the straight section 103, the pre-bending section 102 and the bending adjustment section 101 are coaxial. By coaxially arranging the straight section 103, the pre-bending section 102 and the bending adjustment section 101, the operation of the traction wire assembly 300 can be better controlled, and the position of the bending adjustment section 101 relative to the pre-bending section 102 can be accurately adjusted.
[0138] In the optional solution of the embodiment, the hardness of the straight section 103 is greater than the hardness of the pre-bending section 102, and the hardness of the pre-bending section 102 is greater than the hardness of the bending adjustment section 101. When the controllable bending sheath is in the bending adjustment action, the bending adjustment section 101 can avoid driving the pre-bending section 102 and the straight section 103 to bend.
[0139] Referring to Figure 6 As shown in the figure, in the optional scheme of the embodiment, the sheath assembly 100 has a three-layer structure, including a sheath inner layer 105, a sheath middle layer 106 and a sheath outer layer 107.
[0140] Optionally, the pull wires are arranged between the sheath inner layer 105 and the sheath middle layer 106, and / or the pull wires are arranged between the sheath outer layer 107 and the sheath middle layer 106; that is, the pull wires can be arranged between the sheath inner layer 105 and the sheath middle layer 106, or the pull wires are arranged between the sheath outer layer 107 and the sheath middle layer 106, or when the number of pull wires is multiple, part of the pull wires are arranged between the sheath inner layer 105 and the sheath middle layer 106, and part of the pull wires are arranged between the sheath outer layer 107 and the sheath middle layer 106.
[0141] Optionally, the sheath inner layer 105 is made of a material with low friction coefficient; by making the sheath inner layer 105 of a material with low friction coefficient, the medical device is facilitated to pass through. Optionally, the sheath inner layer 105 is a high polymer film with low friction coefficient; for example, polytetrafluoroethylene (PTFE).
[0142] Optionally, the sheath middle layer 106 is a spring, a metal braid layer or a hypotube, or other materials. The spring, the metal braid layer or the hypotube has good flexibility and bending resistance, and is convenient for bending adjustment. Optionally, the sheath middle layer 106 is a spring wound by a metal round wire or a flat wire, or the sheath middle layer 106 is a braid layer made of a metal monofilament by one-press-one or two-press-two, or the sheath middle layer 106 is a hypotube cut from a metal tube.
[0143] Referring to Figure 6 As shown in the figure, optionally, each pull wire is provided with a pull wire protective sleeve 108, and the pull wire can move back and forth in the pull wire protective sleeve 108; by the pull wire protective sleeve 108, the pull wire is facilitated to move back and forth, and thus the movement of the bending section 101 is more accurately controlled. For example, the first pull wire 301, the second pull wire 302, the third pull wire 303 and the fourth pull wire 304 are movably arranged in the respective pull wire protective sleeves 108, and the first pull wire 301, the second pull wire 302, the third pull wire 303 and the fourth pull wire 304 can freely move in the respective pull wire protective sleeves 108.
[0144] Optionally, the material of the pull wire protective sleeve 108 is a high polymer material or other materials. Optionally, the material of the pull wire protective sleeve 108 is a high polymer material with low friction coefficient such as PTFE.
[0145] Optionally, the material of the outer layer 107 of the sheath is a polymer material or other material. Optionally, the outer layer 107 of the sheath is made of polymer materials with different hardness; for example, the outer layer 107 of the sheath is made of TPU, Pebax or nylon with different hardness to improve the pushing performance.
[0146] Optionally, the traction wire is made of single or multi-strand stainless steel wire or nickel-titanium wire or other material. Optionally, the traction wire is made of multi-strand stainless steel wire or nickel-titanium wire; the multi-strand traction wire can effectively prevent the single wire from breaking and causing the bending function to fail.
[0147] In an optional scheme of the embodiment, the sheath assembly 100 is provided with a developing member; the developing member is arranged at one or more of the bending section 101, the pre-bending section 102 and the straight section 103. Through the developing member, the doctor can observe whether the controllable bending sheath reaches the lesion position through CT or ultrasound during the operation. Optionally, the developing member is made of platinum-iridium or tantalum, and other materials or coatings that can develop can also be used.
[0148] Referring to Figure 18 Optionally, the developing member includes a first developing ring 111, a second developing ring 112, a third developing ring 113 and a fourth developing ring 114; the first developing ring 111 and the second developing ring 112 are arranged in the bending section 101; the third developing ring 113 is arranged on the pre-bending section 102 close to the bending section 101, and the fourth developing ring 114 is arranged on the straight section 103 close to the pre-bending section 102.
[0149] Optionally, the first developing ring 111 and the second developing ring 112 are spaced apart by 10 mm or other distances.
[0150] The following illustrates the connection mode of the controllable bending sheath described in the embodiment, as follows:
[0151] The sheath assembly 100 is fixed with the hemostatic valve 211 by heat melting or gluing, and the connecting tube 212 is glued to the hemostatic valve 211 and the three-way valve 213 at both ends. The nose end 205 passes through the sheath assembly 100 and is clamped with the front cover 204, and the proximal end of the front cover 204 is clamped with the handle body 209. The first sliding block 2071 with left-handed external threads and the second sliding block 2072 with right-handed external threads are clamped in the two sliding grooves 2091 of the handle body 209, respectively, and can freely slide axially and linearly in the sliding grooves 2091. The two ends of the sliding grooves 2091 are limited by limiting devices to prevent the first sliding block 2071 and the second sliding block 2072 from sliding out of the respective sliding grooves 2091. The external threads of the first sliding block 2071 and the external threads of the second sliding block 2072 are engaged with the first threaded sleeve 207 provided with bidirectional internal threads, respectively. The first threaded sleeve 207 is fixedly connected with the first brake knob 202, and when the first brake knob 202 is rotated, the first threaded sleeve 207 coupled therewith is simultaneously subjected to circumferential movement. The first sliding block 2071 and the second sliding block 2072 engaged in the first threaded sleeve 207 provided with bidirectional internal threads slide axially along the sliding grooves 2091 of the handle body 209 in opposite directions, respectively. The connection mode of the second handle body 210 and the second brake knob 203 is the same, except that the two sliding grooves 2091 of the handle body 209 are distributed upward and downward, and the two sliding grooves 2091 of the second handle body 210 are distributed left and right. One end of the four traction wires is fixed with the traction wire fixing ring 104 by welding or winding, and the other end is introduced from the proximal end of the sheath assembly 100 and then passes through the sliding block, respectively, and is fixed by the traction wire fixing column.
[0152] In the embodiment, the number of traction wires can also be other numbers, such as three, five, six or others. For example, when the number of traction wires is three, one or two brake knobs are arranged at the proximal end and the distal end of the handle body 209, respectively, and the traction wires are reasonably distributed according to the structural position to change the included angle between the plane formed by the traction wires and the central axis plane, so as to adapt to the corresponding heart structure, so as to achieve the effect of three-direction bending adjustment for universal adjustment. Therefore, the number of traction wires can be adjusted according to the actual heart position to be reached, and the handle structure is adaptively changed, which all belong to the protection scope of the present application.
[0153] In the embodiment, the interval angle between the four traction wires, or the included angle between the first traction wire 301 and the second traction wire 302, or the included angle between the third traction wire 303 and the fourth traction wire 304 can be adjusted without affecting the bending effect, such as the change of the above-mentioned angle caused by simple change or installation step of the internal structure of the sheath, which all belong to the protection scope of the present application.
[0154] The controllable bending sheath working principle described in the present embodiment is illustrated as follows (taking left atrial appendage occlusion as an example):
[0155] Referring to Figure 19 and Figure 20 , in use, the first brake knob 202 is rotated to drive the first sliding block 2071 and the second sliding block 2072 to move in opposite directions on the corresponding two sliding grooves 2091 of the handle body 209 through threaded connection, and the sliding block moving towards the proximal end (according to the direction of rotation) drives the traction wire, so that the traction wire is tensioned under stress, and the traction wire on the opposite side is relaxed, so that the bending section 101 deflects to the side under stress. By control, bending in four or more directions can be achieved. Referring to Figure 19 and Figure 20 , taking left atrial appendage surgery as an example, the transvenous right atrium is reached through the guide catheter. Since the pre-bending section 102 of the sheath tube assembly 100 is pre-bent, the first brake knob 202 does not need to be rotated. The foramen ovale 402 is found through the angle of the pre-bending section 102, and the foramen ovale 402 is passed to reach the left atrium 403. At this time, the bending section 101 of the sheath tube assembly 100 can be located at any position A1\A2\A3\A4 of the left atrial appendage 404. As long as one of the first brake knob 202 or the second brake knob 203 is rotated, the bending section 101 of the sheath tube assembly 100 can reach the position A coaxial with the mouth of the left atrial appendage 404.
[0156] Compared with the double-section controllable bending sheath on the market, the controllable bending sheath described in the present embodiment has a pre-bending section 102 with a fixed bending angle, i.e. the pre-bending section 102, which does not need to be operated when passing through the foramen ovale 402. After reaching the left atrial appendage 404, because of the special layout of the traction wire, i.e. the four traction wires form a universal bending, and the central axis plane of the pre-bending section 102 and the second plane 12 and the third plane 13 formed by the four traction wires have an included angle, generally only one brake knob needs to be rotated, and the controllable bending sheath can reach the target position from any point. Specifically, the bending section 101 of the controllable bending sheath described in the present embodiment adjusts the four traction wires in four directions through two knobs, thereby realizing bending in four directions and achieving the technical effect of universal adjustment. The bending section 101 is more flexible and controllable, and universal bending can be achieved without rotating the sheath tube.
[0157] In the present embodiment, the central axis plane of the pre-bending section 102 and the second plane 12 and the third plane 13 formed by the four traction wires have an included angle, which has the following advantages: when the controllable bending sheath passes from the left atrium to the left atrial appendage, the four-way bending of the four traction wires is beneficial to the coaxiality of the atrial septal puncture and the left atrial appendage position, and can more easily reach the target position.
[0158] Since the left atrial appendage is mostly located between the anterior and posterior walls of the left atrium, most of them are located at the upper position of the left atrium, and a large part of the low atrial appendage, significantly forward growth or downward corner atrial appendage (such as the right chicken wing type atrial appendage), left atrial appendage occlusion needs to be based on the preoperative evaluation of the anatomical structure of the left atrial appendage and the selection of the appropriate curved catheter sheath in the intraoperative angiography. Accordingly, there are double-bend, single-bend, and slightly forward / backward sheaths on the market to deal with left atrial appendage occlusion in different positions. However, it is not always possible to meet the requirements. In addition to the above situations, when there are large individual differences in the anatomical structure of the left atrial appendage, the operator needs to temporarily shape the sheath tube, which brings certain difficulties to the operator. Therefore, sheath tube manufacturers often need to produce a variety of different sheath tubes, and hospitals also need to stock a large number of various sheath tubes.
[0159] In left atrial appendage occlusion, the axial direction of the sheath tube greatly affects the success rate of occlusion. When using a pre-bent sheath tube for surgery, the selection of the atrial septal puncture site is important, which will directly determine whether the axial direction is good or not. For regular atrial appendages, it is generally recommended to puncture the atrial septum at the lower and posterior positions, and other positions of the atrial appendage need to be punctured at the appropriate site under the guidance of medical equipment. The use of the controllable bending sheath tube described in this embodiment greatly reduces the requirements for the puncture site, and only needs to reach the left atrium and then adjust the axial direction according to the actual atrial appendage position, greatly improving the flexibility and convenience of the operation, and having great significance in clinical application.
[0160] The controllable bending sheath tube described in this embodiment has the following advantages:
[0161] 1. The adjustment of the bending section 101 is more flexible and controllable, and can reach positions that cannot be reached by bidirectional bending sheaths.
[0162] 2. The pre-bend section 102 is a fixed bend. Compared with the two-section controllable bending sheath, the operation is simpler, and when puncturing the oval fossa, it does not need to manually find the angle to pass through the puncture point. Compared with the two-section bending sheath, one step of operation is saved.
[0163] 3. It is more convenient to reach the target position of the operation, and one knob can reach the lesion site in one step.
[0164] 4. The controllable bending sheath can avoid the rotation of the whole sheath tube by the doctor during the operation, reducing the risk of the operation.
[0165] 5. The controllable bending sheath has lower requirements for the experience of the operator than the fixed bending sheath, improves the success rate of the operation, reduces the operation time, and is safer and more reliable for the patient.
[0166] The above merely provides the preferred embodiments of the present application, and is not used to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modifications, equivalent replacements, improvements, etc. made within the principles and technical scope of the present application shall fall into the scope of the present application.
Claims
1. A controllable bending sheath, characterized in that, The sheath assembly (100), the handle assembly (200) and the traction wire assembly (300) are included. The sheath assembly (100) includes a bending adjustment section (101), a pre-bending section (102) and a straight section (103) connected in sequence; the distal end of the straight section (103) is connected with the pre-bending section (102), and the proximal end of the straight section (103) is connected with the handle assembly (200); the pre-bending section (102) is in a fixed bending mode with a preset angle. The handle assembly (200) includes a bending control mechanism. The traction wire assembly (300) is arranged inside the sheath assembly (100) and extends to the inside of the handle assembly (200); the traction wire assembly (300) includes a plurality of traction wires arranged along the circumference of the sheath assembly (100) at intervals; the distal end of each traction wire is fixedly connected with the bending adjustment section (101), and the proximal end of each traction wire is connected with the bending control mechanism; the bending control mechanism is configured to change the position of the bending adjustment section (101) by driving the corresponding traction wire. The number of traction wires is four, which are a first traction wire (301), a second traction wire (302), a third traction wire (303) and a fourth traction wire (304); the first traction wire (301), the third traction wire (303), the second traction wire (302) and the fourth traction wire (304) are arranged along the circumference of the sheath assembly (100) at intervals in sequence. The bending control mechanism is configured to simultaneously drive the first traction wire (301) and the second traction wire (302) to move in opposite directions. The bending control mechanism is configured to simultaneously drive the third traction wire (303) and the fourth traction wire (304) to move in opposite directions. The central axis plane of the pre-bending section (102) is a first plane (11); the first traction wire (301) and the second traction wire (302) form a second plane (12); the third traction wire (303) and the fourth traction wire (304) form a third plane (13); the second plane (12) is perpendicular to the third plane (13), and the second plane (12) and the third plane (13) respectively have an included angle with the first plane (11).
2. The steerable bending sheath of claim 1, wherein, The included angle between the second plane (12) and the third plane (13) and the first plane (11) is 40°-50°.
3. The steerable sheath of claim 1, wherein, The handle assembly (200) further includes a handle body (209); the handle body (209) is sleeved on the straight section (103); The handle body (209) is provided with a sliding mechanism connected with the bending control mechanism, and the sliding mechanism is configured to be driven by the bending control mechanism and reciprocally move along the axial direction of the straight section (103). The number of the sliding mechanisms is two; the two sliding mechanisms are arranged along the axis of the straight section (103) in sequence; the proximal end of the first traction wire (301) and the proximal end of the second traction wire (302) are connected with the first sliding mechanism respectively; the proximal end of the third traction wire (303) and the proximal end of the fourth traction wire (304) are connected with the second sliding mechanism respectively.
4. The steerable sheath of claim 3, wherein, The handle assembly (200) further comprises a threaded sleeve sleeved on the handle body (209); The sliding mechanism is arranged between the handle body (209) and the threaded sleeve, and the sliding mechanism is in threaded transmission connection with the threaded sleeve; the handle body (209) is provided with a sliding groove (2091) connected with the sliding mechanism, and the sliding groove (2091) extends along the axis of the straight section (103); The bending control mechanism is fixedly connected with the threaded sleeve.
5. The steerable sheath of claim 4, wherein, The number of the threaded sleeves is two, which are a first threaded sleeve (207) and a second threaded sleeve (208) respectively; The first sliding mechanism comprises a first sliding block (2071) and a second sliding block (2072); the outer periphery of the first sliding block (2071) and the second sliding block (2072) is respectively provided with external threads, and the direction of the external threads of the first sliding block (2071) is opposite to that of the second sliding block (2072); The second sliding mechanism comprises a third sliding block (2081) and a fourth sliding block (2082); the outer periphery of the third sliding block (2081) and the fourth sliding block (2082) is respectively provided with external threads, and the direction of the external threads of the third sliding block (2081) is opposite to that of the fourth sliding block (2082); along the circumference of the sheath assembly (100), the first sliding block (2071), the third sliding block (2081), the second sliding block (2072) and the fourth sliding block (2082) are arranged in sequence and uniformly spaced; The inner surface of the threaded sleeve is provided with bidirectional internal threads; the external threads of the first sliding block (2071) and the second sliding block (2072) are respectively engaged with the bidirectional internal threads of the first threaded sleeve (207); the external threads of the third sliding block (2081) and the fourth sliding block (2082) are respectively engaged with the bidirectional internal threads of the second threaded sleeve (208); The proximal end of the first traction wire (301) passes through the sliding block through hole (2075) of the first sliding block (2071) and is fixedly connected with the first traction wire fixing block (2073); the proximal end of the second traction wire (302) passes through the sliding block through hole (2075) of the second sliding block (2072) and is fixedly connected with the second traction wire fixing block (2074); The proximal end of the third traction wire (303) passes through the sliding block through hole of the third sliding block (2081) and is fixedly connected with the third traction wire fixing block (2083); the proximal end of the fourth traction wire (304) passes through the sliding block through hole of the fourth sliding block (2082) and is fixedly connected with the fourth traction wire fixing block (2084).
6. The steerable sheath of claim 5, wherein, The handle assembly (200) further comprises a handle shell sleeved on the threaded sleeve; The bending control mechanism comprises a first brake knob (202) and a second brake knob (203); the first brake knob (202) is sleeved on the first threaded sleeve (207), and the first brake knob (202) is fixedly connected with the first threaded sleeve (207); the second brake knob (203) is sleeved on the second threaded sleeve (208), and the second brake knob (203) is fixedly connected with the second threaded sleeve (208); Along the axial direction of the sheath tube assembly (100), the first brake knob (202) and the second brake knob (203) are respectively located at the two ends of the handle shell.
7. The steerable sheath of claim 6, wherein, The handle shell comprises a front cover (204), a shell body (201) and a rear cover (206) arranged in sequence along the axial direction of the sheath tube assembly (100); wherein the shell body (201) is located at the proximal end of the front cover (204); The handle shell further comprises a nose end (205) connected to the distal end of the front cover (204); Along the axial direction of the sheath tube assembly (100), the nose end (205) is provided with at least one nose end groove (2051).
8. The steerable sheath of claim 4, wherein, The distal end of the bending adjustment section (101) is fixedly connected with a traction wire fixing ring (104); the distal end of each traction wire is fixedly connected with the traction wire fixing ring (104); the traction wire fixing ring (104) is coaxially arranged with the bending adjustment section (101); The distal end of the straight body section (103) is fixedly connected with the proximal end of the pre-bending section (102), and the proximal end of the straight body section (103) is fixedly connected with the handle assembly (200); The distal end of the pre-bending section (102) is fixedly connected with the proximal end of the bending adjustment section (101); The bending angle of the pre-bending section (102) is 40°-50°.
9. The steerable sheath of claim 8, wherein, The bending angle of the pre-bending section (102) is 45°. The hardness of the straight body section (103) is greater than the hardness of the pre-bending section (102), and the hardness of the pre-bending section (102) is greater than the hardness of the bending adjustment section (101).
10. The steerable sheath of claim 1, wherein, The sheath tube assembly (100) comprises a sheath tube inner layer (105), a sheath tube intermediate layer (106) and a sheath tube outer layer (107); The traction wire is arranged between the sheath tube inner layer (105) and the sheath tube intermediate layer (106), and / or the traction wire is arranged between the sheath tube outer layer (107) and the sheath tube intermediate layer (106); The sheath tube intermediate layer (106) is a spring, a metal woven layer or a hypotube; The sheath tube inner layer (105) is a high polymer film with low friction coefficient; The material of the sheath tube outer layer (107) is a high polymer material; The sheath assembly (100) is provided with a developing element; the developing element is arranged at one or more of the bending section (101), the pre-bending section (102) and the straight section (103).
Citation Information
Patent Citations
Bending-adjustable sheathing canal
CN115779232A
Pace-making sheathing canal of right-side access Xi-Pu system
CN211835839U