Tissue suturing device for endoscope
By designing a tissue suture device for endoscopy, the tissue is pierced with a curved and extended needle-like puncture part, the problem of slipping and disengaging of device clips such as hemostasis clips is solved, and the safety and success rate of the surgery are improved.
Patent Information
- Application Number
- CN202420978126.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-07
- Publication Date
- 2025-03-25
- Estimated Expiration
- 2034-05-07
AI Technical Summary
In the prior art, the clips of devices such as hemostasis clips are prone to slip off the tissue, resulting in problems such as late perforation.
A tissue suture device for an endoscope is designed, including a clamp seat and a plurality of clamp arms. The puncture portion of the clamp arms is a needle-like structure that can penetrate tissue in a closed position and increase clamping force.
It effectively avoids the clamping arm slipping from the tissue, maintains the stability of clamping tissue, reduces the risk of late perforation, and improves the safety and success rate of the surgery.
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Figure CN222657106U_ABST
Abstract
Description
Technical Field
[0001] The present application belongs to the technical field of medical devices, and specifically relates to a tissue suturing device for an endoscope. Background Art
[0002] As a surgical device, hemostatic clips can quickly seal tissues and reduce delayed bleeding. They are receiving more and more attention and are widely used in clinical practice. Metal hemostatic clips are physical hemostatic devices, which means that the tissues and bleeding vessels around the wound are clamped and fixed by the closing force between the arms of the hemostatic clips, thereby achieving the effect of hemostasis.
[0003] For generally smaller wounds, ordinary clips can be used to ligate them and achieve the purpose of hemostasis. For larger wounds, purse string sutures or one-by-one closures are often used, but in related technologies, the clips often slip during the process of clamping tissues, and may even fall off after clamping tissues, resulting in delayed perforation and other problems. Utility Model Content
[0004] Purpose of the utility model: The embodiment of the present application provides a tissue suturing device for an endoscope, aiming to overcome the technical problem in the related art that the clips of devices such as hemostatic clips are easily slipped off the tissue.
[0005] Technical solution: A tissue suturing device for endoscope described in an embodiment of the present application comprises:
[0006] The clamping seat is provided with a channel, and the channel penetrates the clamping seat along a first direction;
[0007] A plurality of clamp arms, each of which comprises a main body and a puncture portion connected to each other, wherein at least a portion of the main body is disposed in the channel, and at least a portion of the puncture portion is disposed outside the channel; the main body is configured to drive the puncture portion to move relative to the clamp seat when subjected to a force in the first direction, so that the puncture portions of the plurality of clamp arms move between a closed position and an open position;
[0008] The puncture portion is a curved and extended needle-like structure, and is configured so that when the puncture portion is located in the closed position, at least a portion of the puncture portion can pierce tissue.
[0009] In some embodiments, the piercing force of the piercing portion is F, satisfying: 0N <F≤1.2N。
[0010] In some embodiments, the puncture portions of the plurality of clamp arms can relatively move along the second direction to the closed position;
[0011] When located at the closed position, the puncture portions of the plurality of clamp arms are arranged along a third direction;
[0012] The first direction, the second direction, and the third direction intersect.
[0013] In some embodiments, when located in the closed position, the orthographic projections of the piercing portions of the plurality of clamp arms along the third direction at least partially overlap.
[0014] In some embodiments, when in the closed position, along the third direction, an orthographic projection of the puncture portion of at least one of the clamp arms is located outside an orthographic projection of the puncture portion of at least another of the clamp arms.
[0015] In some embodiments, the puncture portion comprises:
[0016] A bending section, located outside the channel and connected to the main body, wherein the bending section bends and extends relative to the main body toward a side close to the other clamping arm;
[0017] The needle tip section is connected to a side of the bending section away from the main body, and the needle tip section is used for piercing tissue.
[0018] In some embodiments, the puncture portions of the plurality of clamp arms can relatively move along a second direction to the closed position, and the first direction and the second direction intersect;
[0019] The puncture portion extends toward a side close to a reference plane relative to the main body, and an angle α between the puncture portion and the reference plane satisfies: α<90°; the reference plane is a plane located on the same side of the plurality of clamp arms and parallel to the first direction and the second direction.
[0020] In some embodiments, when the puncture portion is located at the closed position, the orthographic projections of the bent segments of the plurality of puncture portions on the reference plane at least partially overlap.
[0021] In some embodiments, in each of the clamp arms, the needle tip section extends obliquely from the bent section toward a side close to the main body portion.
[0022] In some embodiments, the clamp seat has a central axis extending along the first direction, and when the puncture portion is located in the closed position, the extension direction of the needle tip section has an angle β with the central axis, satisfying: β≤45°.
[0023] In some embodiments, the main body has an assembly space, and the puncture portion is disposed in the assembly space to be connected to the main body.
[0024] In some embodiments, the assembly space is a receiving groove formed by bending the main body, the puncture portion is embedded in the receiving groove, and the main body clamps the puncture portion.
[0025] In some embodiments, the assembly space is an assembly hole provided at an end of the main body away from the clamp seat, and the puncture portion is embedded in the assembly hole.
[0026] In some embodiments, the main body further has a limiting hole, the limiting hole is communicated with the assembly space, and the puncture portion is penetrated through the limiting hole so as to limit the puncture portion in the assembly space through the limiting hole.
[0027] In some embodiments, the puncture portion comprises:
[0028] A limiting step is arranged outside the assembly space and connected to the main body, and the limiting step is used to limit the position of the puncture part relative to the main body.
[0029] In some embodiments, the limiting step is located at an end of the main body away from the clamp seat, and the limiting step includes a transition surface, and the size of the transition surface increases along the direction approaching the main body.
[0030] In some embodiments, the clamp arm further includes a connecting portion, wherein the connecting portion is disposed between the main body portion and the puncture portion, and the puncture portion is connected to the main body portion via the connecting portion.
[0031] In some embodiments, the clamp arm further has a receiving space, and the receiving space is disposed in the main body;
[0032] When the puncture portion is located at the closed position, the puncture portion can be embedded in the receiving space of the other clamp arm.
[0033] In some embodiments, the number of the piercing portion of each clamp arm is one.
[0034] In some embodiments, the puncture portion is rotatably connected to the main body;
[0035] The tissue suturing device for endoscope also includes a driving part, which is arranged in the channel and connected to the puncture part. The driving part is used to drive the puncture part to rotate relative to the main body so that the puncture part can approach and move away from the other clamp arm.
[0036] In some embodiments, the clamp arm further includes a hinged portion, the puncture portion is rotatably connected to the main body portion via the hinged portion, the drive portion is hinged to the puncture portion, and the drive portion moves along the channel to pull the puncture portion to rotate relative to the main body portion.
[0037] In some embodiments, the tissue suturing device for endoscope further includes a driven portion disposed on the puncture portion, the driving portion is connected to the puncture portion via the driven portion, and the driving portion drives the driven portion to rotate to drive the puncture portion to rotate relative to the main body.
[0038] In some embodiments, a barb structure is provided on the puncture portion.
[0039] In some embodiments, the tissue suturing device for endoscope further comprises:
[0040] The electrical connection part is arranged in the channel and is electrically connected to the puncture part.
[0041] In some embodiments, the tissue suturing device for endoscope further comprises:
[0042] A sheath tube connected to the clamp seat, wherein the sheath tube is configured to be subjected to a preset tension and be able to be separated from the clamp seat;
[0043] A control line is passed through the sheath tube and connected to the clamp arm; the control line is configured to be separated from the clamp arm when a preset pulling force is applied.
[0044] Beneficial effects: The tissue suturing device for endoscope of the embodiment of the present application comprises: a clamp seat, which is provided with a channel, and the channel passes through the clamp seat along a first direction; a plurality of clamp arms, the clamp arms comprising a main body and a puncture portion connected to each other, at least a part of the main body is arranged in the channel, and at least a part of the puncture portion is arranged outside the channel; the main body is configured to be able to drive the puncture portion to move relative to the clamp seat when subjected to a force along the first direction, so that the puncture portions of the plurality of clamp arms can move between a closed position and an open position; the puncture portion is a curved and extended needle-like structure, and the puncture portion is configured so that when it is in the closed position, at least a part of the puncture portion can penetrate the tissue. In the tissue suturing device of the embodiment of the present application, the clamp arm includes a puncture part, which is a curved and extended needle-like structure, so that in the process of the puncture parts of multiple clamp arms moving relative to each other to a closed position, the puncture part can penetrate into the muscle layer tissue, thereby firmly grasping the muscle layer tissue, effectively preventing the clamp arm from slipping from the tissue, maintaining the stability of the clamped tissue, reducing the risk of falling off after clamping the tissue, and effectively reducing the occurrence of delayed perforation and other problems, which can improve the safety of the operation, reduce the difficulty of the doctor's operation, and improve the success rate of endoscopic surgery. BRIEF DESCRIPTION OF THE DRAWINGS
[0045] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without paying any creative work.
[0046] Figure 1 A schematic structural diagram of an endoscope tissue suturing device in an open state provided in an embodiment of the present application;
[0047] Figure 2 A schematic structural diagram of a tissue suturing device for an endoscope in a closed state provided in an embodiment of the present application;
[0048] Figure 3 A schematic diagram of the three-dimensional structure of the tissue suturing device for an endoscope in a closed state provided in an embodiment of the present application;
[0049] Figure 4 To observe along the first direction Figure 4 A schematic diagram of the structure of a tissue suturing device for an endoscope;
[0050] Figure 5 A schematic diagram of the structure of a tissue suturing device for an endoscope in some embodiments of the present application observed along a first direction;
[0051] Figure 6 A schematic structural diagram of a tissue suturing device for an endoscope according to a first embodiment of the present application, viewed along a first direction;
[0052] Figure 7 A schematic structural diagram of a tissue suturing device for an endoscope according to a second embodiment of the present application, viewed along a first direction;
[0053] Figure 8 A schematic structural diagram of a tissue suturing device for an endoscope according to a third embodiment of the present application when viewed along a first direction;
[0054] Fig. 9 A schematic structural diagram of a tissue suturing device for an endoscope according to a fourth embodiment of the present application observed along a third direction;
[0055] Fig.10 A schematic structural diagram of the clamping arm of the tissue suturing device for endoscope in the fifth embodiment of the present application in the closed state when viewed from the third direction;
[0056] Fig.11 A schematic diagram of the three-dimensional structure of a tissue suturing device for an endoscope in an open state provided in a sixth embodiment of the present application;
[0057] Fig.12 for Fig.11 A schematic structural diagram of another perspective of an endoscopic tissue suturing device;
[0058] Fig.13 A schematic structural diagram of a tissue suturing device for an endoscope in an open state provided in a seventh embodiment of the present application;
[0059] Fig.14 for Fig.13 A schematic diagram of the three-dimensional structure of the tissue suturing device for endoscope in the open state;
[0060] Fig.15 for Fig.14 A schematic structural diagram of another perspective of an endoscopic tissue suturing device;
[0061] Fig.16 A schematic diagram of the partial structure of the main body of the tissue suturing device for endoscope provided in the eighth embodiment of the present application;
[0062] Fig.17 A schematic diagram of a partial structure of a clamp arm of an endoscopic tissue suturing device provided in a ninth embodiment of the present application;
[0063] Fig.18 A schematic structural diagram of a tissue suturing device for an endoscope in an open state provided in a tenth embodiment of the present application;
[0064] Fig.19 A schematic structural diagram of an endoscopic tissue suturing device in an open state provided in the eleventh embodiment of the present application;
[0065] Fig. 20 for Fig.19 A schematic diagram of the local enlarged structure of the middle A area;
[0066] Fig.21 A schematic structural diagram of a tissue suturing device for an endoscope in an open state provided in the twelfth embodiment of the present application;
[0067] Fig. 22 for Fig.21 A schematic diagram of the local enlarged structure of the middle B area;
[0068] Fig.23 A schematic diagram of a partially enlarged structure of a clamp arm of a tissue suturing device for an endoscope provided in the thirteenth embodiment of the present application;
[0069] Fig.24 This is a schematic diagram of the overall structure of the tissue suturing device for endoscope according to an embodiment of the present application;
[0070] Figure markings: 100-clamp seat; 110-channel; 200-clamp arm; 210-main body; 211-assembly space; 212-accommodating groove; 213-assembly hole; 214-limiting hole; 215-accommodating space; 220-puncture part; 221-bending section; 222-needle tip section; 223-limiting step; 2231-transition surface; 224-connecting section; 225-limiting section; 230-connecting part; 240-hinge part; 250-driven part; 260-driving part; 270-barb structure; 300-sheath tube; 400-control line; 500-handle. DETAILED DESCRIPTION
[0071] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present application.
[0072] In the description of the present application, it should be understood that the terms "proximal end" and "distal end" are used as reference objects by the surgical operator (doctor), wherein the "proximal end" is the end of the surgical tool closer to the operator, and the "distal end" is the end farther away from the operator relative to the "proximal end", that is, the end closer to the patient. The orientation or positional relationship indicated by the terms "upper", "lower", "top", "bottom", "inside", "outside", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. In the description of the present application, the meaning of "multiple" is two or more, and at least one refers to one, two or more, unless otherwise clearly and specifically defined.
[0073] It should also be noted that in the drawings of the embodiments of the present application, arrows marked with X, Y, and Z respectively represent the first direction X, the second direction Y, and the third direction Z. The first direction X, the second direction Y, and the third direction Z are introduced in the description of the present application in order to more clearly describe the structure and relative position relationship of each component in the tissue suturing device for endoscope. The first direction X, the second direction Y, and the third direction Z are perpendicular to each other. In practical applications, the first direction X, the second direction Y, and the third direction Z can point to any direction in space.
[0074] In the related art, the size of the hemostatic clips used in endoscopic surgery is small and the gripping force is weak. Especially under the lubrication of the mucus in the body, the clips can easily slip off the tissue surface, making the operation more difficult. In addition, due to the weak gripping force of the clips, they are prone to fall off after clamping the tissue, which can lead to delayed perforation and other problems.
[0075] In view of this, the embodiment of the present application provides a tissue suturing device for endoscope, which can reduce the slipping of the clip from the tissue, improve the suturing efficiency of endoscopic clinical surgery, and reduce the risk of instrument failure. In particular, the tissue suturing device for endoscope has a good effect in treating gastroesophageal reflux disease. Patients with gastroesophageal reflux disease generally have a reflux of gastric acid in the stomach due to the relaxation of the sphincter of the cardia, which enters the esophagus through the cardia, thereby causing adverse reactions to the esophagus. Using the tissue suturing device for endoscope of the embodiment of the present application, the muscle layer tissue near the cardia is clamped and sutured. The suturing methods generally used are longitudinal suturing along the lesser curvature and circular suturing around the cardia. By suturing the gastric wall tissue to form wrinkles, the tension near the cardia is increased, the length of the esophagus in the abdominal cavity is extended, the gastroesophageal junction is effectively tightened, the reflux barrier is enhanced, and a therapeutic effect is exerted.
[0076] Please also read Figures 1 to 4 A tissue suturing device for an endoscope provided in an embodiment of the present application includes a clamp seat 100 and a plurality of clamp arms 200. The plurality of clamp arms 200 can be movably assembled in the clamp seat 100. By manipulating the movement of the clamp arms 200 relative to the clamp seat 100, the opening, closing, locking and release of the tissue suturing device can be achieved.
[0077] The clamp seat 100 has a channel 110 extending through the first direction X. The number of the clamp arms 200 is at least two, that is, the tissue suturing device for an endoscope may have only two clamp arms 200, or more clamp arms 200 may be provided according to actual application requirements. It is understandable that in the tissue suturing device for an endoscope, at least two clamp arms 200 can cooperate with each other to open and close each other, thereby facilitating passage through the catheter of the endoscope and clamping the tissue.
[0078] Specifically, the clamp arm 200 includes a main body 210 and a puncture portion 220 connected to each other, at least a portion of the main body 210 is disposed in the channel 110, and at least a portion of the puncture portion 220 is located outside the channel 110. The main body 210 is configured to drive the puncture portion 220 to move relative to the clamp seat 100 when subjected to a force along the first direction X, so that the puncture portions 220 of the plurality of clamp arms 200 move between a closed position and an open position, thereby realizing that the plurality of clamp arms 200 are mutually opened and closed.
[0079] The main body 210 is a bearing structure of the puncture part 220, and the main body 210 can be movably assembled on the clamping base 100. Optionally, the main body 210 can be partially located in the channel 110, or can be completely located in the channel 110. In the process of the clamping arms 200 opening and closing with each other, the main body 210 can move relative to the clamping base 100.
[0080] The puncture portion 220 is a component of the tissue suturing device that can be used to puncture tissue, and it is presented as a curved and extended needle-like structure. In the description of the present application, a needle-like structure refers to a structure with an elongated shape and a sharp end. Specifically, the thinnest position of the needle-like structure is located at its end, and the portion close to the end thereof is tapered. In some embodiments, the extension length of the needle-like structure is L, and the width of the needle-like structure is M, satisfying L / M≥4. Among them, the width of the needle-like structure is the size of its thickest position. When the cross-section of the needle-like structure is circular, the width M is the diameter at its thickest position; the cross-section of the needle-like structure can also be other shapes, such as elliptical, polygonal, and other regular or irregular shapes, and accordingly, the width M is the size at the thickest position; the width M can be measured by a size measuring tool such as a micrometer. In some embodiments, the curved and extended needle-like structure presented by the puncture portion 220 is similar to a medical suture needle.
[0081] Optionally, the puncture portion 220 may be completely located outside the channel 110, or only partially located outside the channel 110. During surgery, when the puncture portion 220 is located in the closed position, the clamp arms 200 are closed to each other and can clamp the muscle layer tissue. At this time, at least a portion of the puncture portion 220 can penetrate into the tissue, thereby firmly grasping the muscle layer tissue, effectively avoiding slipping from the tissue, maintaining the stability of the clamped tissue, and reducing the difficulty of the surgical operation.
[0082] In some embodiments, the number of puncture parts 220 in each clamp arm 200 is one, that is, each clamp arm 200 has only one puncture part 220. Compared with the embodiment in which each clamp arm 200 includes multiple puncture parts 220, in the tissue suturing device of this embodiment, during the operation, each clamp arm 200 has only one puncture part 220 in contact with the tissue. At the contact position, the clamp arm 200 exerts a greater pressure on the tissue, so it is easier to penetrate the tissue and can clamp more securely.
[0083] See also Fig.18 In some embodiments, the number of puncture parts 220 in each clamp arm 200 is multiple, for example, two or more, and the multiple puncture parts 220 of each clamp arm 200 can be arranged along the third direction Z. Optionally, when the puncture parts 220 of the multiple clamp arms 200 are in the closed position, the puncture parts 220 of the multiple clamp arms 200 can be alternately arranged along the third direction Z.
[0084] In some embodiments, the piercing force of the piercing portion 220 is F, satisfying: 0N < F ≤ 1.2N, where N is the unit of piercing force in Newtons. That is to say, the piercing force of the piercing portion 220 can be any value among 0.1N, 0.2N, 0.3N, 0.4N, 0.5N, 0.6N, 0.7N, 0.8N, 0.9N, 1.0N, 1.1N, 1.2N or the range value between any two values. Controlling the piercing force within this range, the piercing portion 220 is sharp enough and is more likely to penetrate into the muscle tissue, reducing the difficulty of the doctor's operation and improving the success rate of the endoscopic surgery. Within this range, the smaller the piercing force, the sharper the piercing portion 220, and the easier it is to penetrate into the muscle tissue during the operation, and the higher the stability of the clamping arm 200 for clamping the tissue; as the piercing force increases, the piercing portion 220 becomes relatively thicker, and correspondingly, the strength of the piercing portion 220 increases, the processing difficulty decreases, and the product yield is higher.
[0085] The piercing force F of the piercing portion 220 of the tissue suturing device for endoscopy can be tested according to the method for testing the piercing force and strength of the needle tip recorded in Appendix C of the industry standard YY / T 0043-2016 for medical suture needles. The test principle is: the maximum peak force measured by vertically piercing the test material with the piercing portion 220 at a specified speed is used to evaluate the piercing force of the piercing portion 220. The test instrument uses the suture needle tip piercing force measuring instrument recorded in Appendix C.4 of this appendix, and the instrument requirements meet Appendix C.4.2. The test material uses aluminum foil, and it is required that the surface of the aluminum foil should be clean, smooth, without overlap or severe wrinkles, mildew spots, and sand holes; the aluminum foil is a soft material with a thickness of 0.05mm ± 0.002mm and a purity of not less than 99.5%; the tensile strength of the aluminum foil is not less than 3kg / mm 2 , and the elongation rate should be not less than 3%. The piercing force test is carried out according to the method in Appendix C.6.2 of this appendix, specifically as follows:
[0086] Clamp the appropriately sized aluminum foil on the aluminum foil fixture without applying any obvious tensile or compressive force on the aluminum foil;
[0087] Clamp the piercing portion 220 on the needle fixture, press the control switch, and through the transmission system, gradually apply a vertical force to the aluminum foil with the piercing portion 220, and the swing rod rotates accordingly. When the force acting on the piercing portion 220 exceeds the strength of the aluminum foil, the piercing portion 220 pierces through the aluminum foil and contacts the electrode, and the instrument automatically stops applying force. At this time, the value indicated by the pointer on the swing rod (or the value on the display instrument) is the piercing force of the piercing portion 220;
[0088] Press the working control button to reset the swing rod and pointer (display instrument reading) of the instrument;
[0089] Release the aluminum foil fixture, move the aluminum foil inside the fixture so that the distance between each piercing hole is more than 3 times the diameter of the piercing portion 220;
[0090] Repeat the above steps, measure three times, and take the arithmetic mean value, which is the puncture force of the puncture portion 220.
[0091] It should be noted that the size of the aluminum foil can be determined according to the number of puncture holes and the spacing between the puncture holes, and the spacing between the puncture holes is required to be greater than 3 times the diameter of the puncture portion 220. The cross section of the puncture portion 220 perpendicular to its extension direction may not be a standard circle, but may also be a triangle or other irregular shapes, and its diameter may be equivalent to the size of the thickest position of the puncture portion 220, which can be measured by a measuring tool such as a micrometer.
[0092] In some embodiments, when the main body 210 is subjected to a force in the first direction, it can move relative to the clamp seat 100 along the first direction X and drive the puncture portion 220 to move, so that the puncture portions 220 of the multiple clamp arms 200 can move relative to each other in the second direction Y to a closed position. By applying a driving force and causing the force in the first direction X to act on the main body 210, the main body 210 can be driven to move relative to the clamp seat 100 in the first direction X, thereby driving the puncture portions 220 of the multiple clamp arms 200 to produce relative movement in the second direction Y, so that the puncture portions 220 of the multiple clamp arms 200 move to a closed position, thereby achieving the closure of the multiple clamp arms 200 of the tissue suturing device. Please refer again Figure 2 , Figure 3 and Figure 4 When the puncture part 220 is in the closed position, the multiple puncture parts 220 that are closed to each other are arranged along the third direction Z to form a staggered structure, so that when clamping the muscle layer tissue, different puncture parts can pierce different positions of the muscle layer tissue and squeeze the muscle layer tissue at the staggered positions, so that the muscle layer tissue produces twisted wrinkles, so that the wound on the tissue is more tightly closed. This can improve the effect of wound suturing, and further improve the effect of surgery.
[0093] Please refer to the Figure 2 , Figure 3 and Figure 4 Optionally, when the puncture portion 220 is in the closed position, the orthographic projections of the puncture portions 220 of the plurality of clamp arms 200 along the third direction Z at least partially overlap. Therefore, in the process of mutual closure, after the puncture portion 220 pierces the muscle layer tissue, as the clamp arms 200 gradually close, the puncture portion 220 has a larger relative movement range, a greater clamping force, and a more sufficient compression of the tissue, and can gradually gather the clamped tissue to form wrinkles, thereby improving the suturing effect; and can also clamp the tissue more firmly to avoid slipping from the tissue, thereby avoiding problems such as delayed perforation.
[0094] Among them, any virtual plane located on the same side of the plurality of clamp arms 200 and perpendicular to the third direction Z can be selected as the reference plane. For example, Figure 4 and Figure 5 The AA' plane is a reference plane. When the clamp arms 200 are in the closed position, the projections of the puncture parts 220 of at least two clamp arms 200 that are closed to each other on the AA' plane at least partially overlap. In practice, a plane structure perpendicular to the third direction Z can be set on the same side of the multiple clamp arms 200 as a reference plane, and by projecting onto the plane structure, it can be verified whether the orthographic projections of the puncture parts 220 on the plane structure have overlapping parts.
[0095] In some embodiments, when in the closed position, along the third direction Z, the orthographic projection of the puncture portion 220 of at least one clamp arm 200 is located outside the orthographic projection of the puncture portion 220 of at least another clamp arm 200. For example, the orthographic projection of the puncture portion 220 of one clamp arm 200 is located above the orthographic projection of the puncture portion 220 of another clamp arm 200, so that when clamping tissue, the degree of squeezing of the muscle layer tissue can be increased, so that the wound on the tissue is sealed more tightly. For details, please refer to Fig. 9 , the dotted lines indicate the same horizontal position, wherein the length of the clamp arm 200 on the left side is longer, and thus the height of its puncture portion 220 is higher. When in the closed position, along the third direction Z, the orthographic projection of the puncture portion 220 of the left clamp arm 200 is located above the orthographic projection of the puncture portion 220 of the right clamp arm 200.
[0096] In some embodiments, the puncture portion 220 of the endoscopic tissue suturing device can be made of a suturing needle currently used in surgical operations.
[0097] Please also read Figures 1 to 4 In some embodiments, the puncture portion 220 includes a bending section 221 and a needle tip section 222. The bending section 221 is located outside the channel 110 and connected to the main body 210. The bending section 221 bends and extends relative to the main body 210 toward a side close to the other clamp arm 200; the needle tip section 222 is connected to an end of the bending section 221 away from the main body 210, and the needle tip section 222 is used to pierce the tissue. The needle tip section 222 extends from the end of the bending section 221, and the needle tip section 222 decreases in size along its extension direction to form a needle tip structure.
[0098] The bending section 221 is the part of the puncture section 220 that is bent toward the side close to the other clamp arm 200. The bending section 221 can be in a curved shape or a broken line shape. In order to improve the overall structural strength of the puncture section 220, in some embodiments, the bending section 221 can be set to a circular arc shape so that the force on the entire structure is more uniform during clamping, and the clamping is more secure. The needle tip section 222 is the tip portion set at one end of the bending section 221, which is used to directly pierce the tissue. Therefore, the needle tip section 222 is a sharper structure than the bending section 221. Please refer to the following figure for details. Fig.13 In some embodiments, the size of the needle tip section 222 may be its outer diameter D, which can be measured by a measuring tool such as a vernier caliper or a micrometer, or by other measuring means under a microscopic imaging perspective. The outer diameter D decreases along the extension direction of the needle tip section 222, thereby forming a sharp structure, reducing the piercing force, and facilitating penetration into tissues.
[0099] It should also be noted that the needle tip section 222 of the puncture portion 220 may be an integral structure with the bend section 221, that is, the two are formed in one piece. There may be no obvious connecting boundary between the needle tip section 222 and the bend section 221 in structure, and the needle tip section 222 may be the portion of the entire puncture portion 220 that is reduced in size along the extension direction and forms a relatively sharp tip. It should also be noted that in some embodiments, the extension direction of the needle tip section 222 may not be a standard straight line, that is, the needle tip section 222 may have some curvature.
[0100] In some embodiments, the puncture portion 220 extends toward a side close to the reference plane AA' relative to the main body 210, and the angle between the puncture portion 220 and the reference plane AA' is α, satisfying: α<90°. Figure 5 From the perspective of the figure, the two clamp arms 200 are in an open state, and the puncture parts 220 of the two clamp arms 200 can be tilted toward the direction of the reference plane AA' close to the upper side of the figure. During the closing process of the clamp arms 200, the needle tip section 222 of each puncture part 220 can be closer to the muscle layer tissue and move to contact the tissue at an angle that is easier to penetrate the muscle layer tissue, thereby making it easier to penetrate the tissue.
[0101] It can be understood that in this embodiment, by extending the puncture portion 220 toward the side close to the reference plane AA' relative to the main body 210, the tissue suturing device can form an angle with the muscle layer tissue after entering the human organ through the endoscopic forceps channel, so that the doctor does not need to control the angle of the clamp seat 100 too much, and the puncture portion 220 can contact the tissue and achieve a suitable insertion angle. The needle tip section 222 can more easily penetrate the muscle layer tissue, thereby making it easier to clamp the tissue, thereby effectively reducing the difficulty of operation.
[0102] It should be noted that, in the actual product, the angle between the puncture portion 220 and the reference plane AA' can be determined in the following manner, and a proportional three-dimensional model of the actual product can be established. By establishing the three-dimensional model, the accurate size and shape information of the tissue suturing device can be obtained, and then in the three-dimensional model, according to Figures 5 to 8 The angle between the plane fitted by the midline of the puncture portion 220 and the reference plane AA' is measured as its extension direction, and the angle α is then determined.
[0103] Optional, please also see Figures 5 to 8 In some embodiments, the angle between the puncture portion 220 and the reference plane AA' is α, which satisfies: α<90°, for example, α can be any angle value among 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 89°, or a range value between any two angle values. Controlling the angle α within the above range can effectively improve the grasping efficiency and reduce the difficulty of operation, while facilitating the mutual closure of the two clamp arms 200 that cooperate with each other to avoid interference between the two during the closing process. Optionally, α<45°. Within this angle range, the larger the angle α, the easier it is for the puncture portion 220 to penetrate the tissue, and the lower the difficulty of operation.
[0104] Please refer again Figure 2 In some embodiments, when the puncture parts 220 are in the closed position, the orthographic projections of the bent sections 221 of the mutually closed puncture parts 220 on the reference plane AA' at least partially overlap. That is, in the closed position, the bent sections 221 of the multiple puncture parts 220 are arranged in a staggered manner. In the process of mutual closure, after the needle tip section 222 pierces the muscle layer tissue, as the puncture parts 220 are gradually closed, the bent sections 221 gradually intersect with each other, the relative movement range of the needle tip section 222 is larger, the clamping force is greater, and the compression of the tissue is more sufficient, thereby improving the suturing effect.
[0105] See also Fig.10 In some embodiments, in each clamp arm 200, the needle tip section 222 extends obliquely from the bent section 221 toward the side close to the main body 210. In other words, the needle tip section 222 of the puncture section 220 is retracted, so that when the tissue suturing device is in an open state and the two clamp arms 200 that cooperate with each other open to each other at a large angle, the needle tip section 222 of the puncture section 220 can form a suitable penetration angle with the muscle layer tissue, so that more tissue can be clamped, so that more tissue can be gathered to form folds, and the suturing effect is further improved.
[0106] Please refer again Figure 2 and Fig.10In some embodiments, the clamp seat 100 has a central axis OO' extending along the first direction X, and the clamp arm 200 is driven to move along the central axis OO'. When the clamp arm 200 is in the closed position, the extension direction of the needle tip section 222 has an angle β with the first direction X, satisfying: β≤45°. For example, β can be any angle value of 1°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, or a range value between any two angle values. Within this range, as the angle increases, the maximum opening angle between the multiple clamp arms 200 can be set larger accordingly.
[0107] Please also read Figures 11 to 17 In some embodiments, the main body 210 has an assembly space 211 , and the puncture portion 220 is disposed in the assembly space 211 to be connected to the main body 210 .
[0108] For details, please refer to Fig.11 and Fig.15 In the sixth and seventh embodiments, the assembly space 211 is a receiving groove 212 formed by bending the main body 210, the puncture part 220 is embedded in the receiving groove 212, and the main body 210 clamps the puncture part 220. During manufacturing, a sheet structure of metal or other materials is used to stamp and bend to form the receiving groove 212, and the connecting section 224 of the puncture part 220 is embedded in the receiving groove 212, and the two bent side wings of the main body 210 are clamped to clamp the puncture part 220. Among them, the connecting section 224 is a component connecting the puncture part 220 and the main body 210, and the connecting section 224 can be set at the end of the bending section 221 away from the needle tip section 222.
[0109] See also Fig.16 The eighth embodiment is different from the sixth embodiment and the seventh embodiment. In the eighth embodiment, the assembly space 211 is an assembly hole 213 formed at one end of the main body 210 away from the clamping seat 100, and the puncture portion 220 is inserted into the assembly hole 213 to achieve the connection between the puncture portion 220 and the main body 210. Specifically, the connection section 224 of the puncture portion 220 can be inserted into the assembly hole 213 of the main body 210.
[0110] Please refer again Fig.13 , Fig.14 and Fig.15In the seventh embodiment, the main body 210 further has a limiting hole 214, which is in communication with the assembly space 211, and the puncture portion 220 is inserted through the limiting hole 214, so as to limit the puncture portion 220 in the assembly space 211 through the limiting hole 214. Specifically, the connecting section 224 of the puncture portion 220 can be bent to form a limiting section 225, and the limiting section 225 is inserted into the limiting hole 214 so that the main body 210 can be hooked, thereby limiting the puncture portion 220 so that it will not move or rotate along the assembly space 211. This can further improve the strength of the overall structure and the firmness of clamping tissues.
[0111] Please refer again Fig.11 and Fig.12 In the sixth embodiment, the puncture portion 220 includes a limiting step 223, which is arranged outside the assembly space 211 and connected to the main body 210. The limiting step 223 is used to limit the position of the puncture portion 220 relative to the main body 210. By setting the limiting step 223, the puncture portion 220 is prevented from continuing to move into the assembly space 211 relative to the main body 210, so that in the process of clamping the tissue, the clamping force can be guaranteed to be continuous and stable, and the clamping stability is improved. Specifically, the limiting step 223 can be arranged between the connecting section 224 and the bending section 221, and connected to the connecting section 224 and the bending section 221 respectively.
[0112] Optionally, in the sixth embodiment, the limiting step 223 is located at one end of the main body 210 away from the clamping seat 100, and the limiting step 223 includes a transition surface 2231, and the size of the transition surface 2231 increases along the direction close to the main body 210. Specifically, the size can be as follows: Fig.11 The outer diameter d of the middle limit step 223 can be measured by a measuring tool such as a vernier caliper or a micrometer, or by other measuring means under a microscopic imaging perspective. The direction close to the main body 210 refers to the direction from the distal end to the proximal end. The outer diameter d gradually increases so that the transition of the connection between the puncture part 220 and the main body 210 can be smoother, which can play a guiding role to a certain extent and avoid scratching the endoscope clamp channel when passing through the endoscope.
[0113] See also Fig.17 In the ninth embodiment, the clamp arm 200 further includes a connecting portion 230, which is disposed between the main body 210 and the puncture portion 220 and is respectively connected to the main body 210 and the puncture portion 220. In this embodiment, the puncture portion 220 and the main body 210 are connected together by the auxiliary connecting portion 230.
[0114] Please refer again Fig.17In some embodiments, the main body 210 further has a receiving space 215. When the clamp arm 200 is in the closed position, the puncture portion 220 can be embedded in the receiving space 215 of the other clamp arm 200 to protect the puncture portion 220. It should be noted that the receiving space 215 can be a hole provided on the main body 210, or it can also be a groove provided on the main body 210; in some embodiments, the receiving space 215 can be a receiving groove 212 provided on the main body 210, and the receiving groove 212 is used to assemble the puncture portion 220 of the corresponding clamp arm 200 on the one hand, and can receive the puncture portion 220 of the other clamp arm 200 on the other hand.
[0115] Please also read Figures 19 to 23 In some embodiments, the puncture part 220 is rotatably connected to the main body 210. The tissue suturing device further includes a driving part 260, which is disposed in the channel 110 and connected to the puncture part 220. The driving part 260 is used to drive the puncture part 220 to rotate relative to the main body 210 so that the puncture part 220 can approach or move away from another clamp arm 200. In this embodiment, the puncture part 220 can rotate relative to the main body 210. The puncture part 220 is driven by the driving part 260 to rotate relative to the main body 210 to approach or move away from another clamp arm 200, thereby adjusting the insertion angle of the puncture part 220 relative to the surface of the muscle layer tissue, so that the puncture part 220 can more easily penetrate the muscle layer tissue, thereby improving the success rate of the operation.
[0116] Please also read Fig.21 and Fig. 22 In some embodiments, the clamp arm 200 further includes a hinged portion 240, through which the puncture portion 220 is rotatably connected to the main body 210, and the drive portion 260 is hinged to the puncture portion 220. Under the operation of the operator, the drive portion 260 can move along the channel 110 to pull the puncture portion 220 to rotate relative to the main body 210, so as to adjust the angle of the puncture portion 220 and make it easier to pierce the muscle layer tissue. Specifically, the drive portion 260 can be a steel wire structure, one end of which is an operating end, and the other end is hinged to the puncture portion 220, and the hinge can be located between the hinged portion 240 and the tip of the puncture portion 220. The operator applies a driving force to the operating end to move the wire structure, thereby driving the puncture part 220 to rotate around the hinge part 240, and then the puncture part 220 can rotate relative to the main body 210, so that it moves away from or close to the other clamp arm 200, thereby adjusting the insertion angle of the puncture part 220 and improving the insertion efficiency.
[0117] Please also read Fig.19 and Fig. 20In some embodiments, the tissue suturing device further includes a driven part 250 disposed on the puncture part 220, and the driving part 260 is connected to the puncture part 220 through the driven part 250. The driving part 260 drives the driven part 250 to rotate, so as to drive the puncture part 220 to rotate relative to the main body 210. Specifically, the driving part 260 can be a conveyor belt or a steel wire rope, which is wound around the driven part 250, and drives the driven part 250 to rotate by pulling the two ends of the conveyor belt or the steel wire rope. Alternatively, the driving part 260 can be a gear transmission shaft, and a gear is provided at its end. The driven part 250 can be a bevel gear, and the two are meshed with each other, so as to realize mutual transmission through the bevel gear transmission. During operation, by controlling the rotation of the driving part 260, the driven part 250 can be driven to rotate, and then the puncture part 220 can be driven to rotate relative to the main body 210.
[0118] See also Fig.23 In some embodiments, a barb structure 270 is provided on the puncture portion 220. Specifically, the barb structure 270 can be a needle-like structure connected to the puncture portion 220. The barb structure 270 is provided to improve the ability of the puncture portion 220 to grasp tissue and improve the success rate of the operation.
[0119] In some embodiments, the tissue suturing device for endoscope of the embodiment of the present application further includes a power connection part (not shown in the figure), which is arranged in the channel 110 and electrically connected to the puncture part 220. During the operation, the power connection part is connected to the power source so that the puncture part 220 can be charged, and the current can be used to burn the tissue to assist the surgical suturing.
[0120] See also Fig.24 The tissue suturing device for endoscope of the embodiment of the present application may further include a sheath tube 300, a control line 400 and a handle 500. The sheath tube 300 is arranged between the handle 500 and the clamp seat 100. The control line 400 is arranged inside the sheath tube 300 and connected to the handle 500. By operating the handle 500 at the proximal end and using the control line 400 to transmit the driving force, a series of actions such as opening, closing, locking of the distal clamp arm 200 and release of the clamp seat 100 and the clamp arm 200 are realized, and the clamp seat 100 and the clamp arm 200 are retained in the patient's body, and the wound is clamped and sutured, which greatly improves the efficiency of clinical surgery and reduces the risk of instrument failure.
[0121] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.
[0122] The above is a detailed introduction to the tissue suturing device for endoscope provided in the embodiments of the present application, and the principles and implementation methods of the present application are explained by using specific examples. The description of the above embodiments is only used to help understand the technical solution and core idea of the present application; ordinary technicians in this field should understand that: they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some of the technical features therein with equivalents; and these modifications or replacements do not make the essence of the corresponding technical solution deviate from the scope of the technical solution of the embodiments of the present application.
Claims
1. A tissue suturing device for an endoscope, characterized in that: include: The clamping seat (100) is provided with a channel (110), wherein the channel (110) penetrates the clamping seat (100) along a first direction (X); A plurality of clamp arms (200), wherein the clamp arms (200) include a main body (210) and a puncture portion (220) connected to each other, wherein at least a portion of the main body (210) is disposed in the channel (110), and at least a portion of the puncture portion (220) is disposed outside the channel (110); the main body (210) is configured to drive the puncture portion (220) to move relative to the clamp seat (100) when subjected to a force along the first direction (X), so that the puncture portions (220) of the plurality of clamp arms (200) move between a closed position and an open position; The puncture portion (220) is a curved and extended needle-like structure, and the puncture portion (220) is configured such that when located in the closed position, at least a portion of the puncture portion (220) can pierce tissue.
2. The tissue suturing device for endoscope according to claim 1, characterized in that: The piercing force of the piercing portion (220) is F, which satisfies: 0N <F≤1.2N。 3. The tissue suturing device for endoscope according to claim 1, characterized in that: The puncture portions (220) of the plurality of clamp arms (200) are capable of relatively moving along a second direction (Y) to the closed position; When located in the closed position, the puncture portions (220) of the plurality of clamp arms (200) are arranged along a third direction (Z); The first direction (X), the second direction (Y), and the third direction (Z) intersect.
4. The tissue suturing device for endoscope according to claim 3, characterized in that: When located in the closed position, the orthographic projections of the puncture portions (220) of the plurality of clamp arms (200) along the third direction (Z) at least partially overlap.
5. The tissue suturing device for endoscope according to claim 3, characterized in that: When in the closed position, along the third direction (Z), the orthographic projection of the puncture portion (220) of at least one of the clamp arms (200) is located outside the orthographic projection of the puncture portion (220) of at least another of the clamp arms (200).
6. The tissue suturing device for endoscope according to claim 1, characterized in that: The puncture portion (220) comprises: a bending section (221), located outside the channel (110) and connected to the main body (210), wherein the bending section (221) bends and extends relative to the main body (210) toward a side close to the other clamping arm (200); The needle tip section (222) is connected to a side of the bending section (221) away from the main body (210), and the needle tip section (222) is used for piercing tissue.
7. The tissue suturing device for endoscope according to claim 6, characterized in that: The puncture portions (220) of the plurality of clamp arms (200) are capable of relatively moving along a second direction (Y) to the closed position, and the first direction (X) and the second direction (Y) intersect; The puncture portion (220) extends relative to the main body (210) toward a side close to a reference plane (AA'), and an angle α between the puncture portion (220) and the reference plane (AA') satisfies: α<90°; the reference plane (AA') is a plane located on the same side of the plurality of clamp arms (200) and parallel to the first direction (X) and the second direction (Y).
8. The tissue suturing device for endoscope according to claim 7, characterized in that: When the puncture portion (220) is located at the closed position, the orthographic projections of the bent sections (221) of the plurality of puncture portions (220) on the reference plane at least partially overlap.
9. The tissue suturing device for endoscope according to claim 6, characterized in that: In each of the clamp arms (200), the needle tip section (222) extends obliquely from the bent section (221) toward a side close to the main body (210).
10. The tissue suturing device for endoscope according to claim 9, characterized in that: The clamping seat (100) has a central axis (OO') extending along the first direction (X), and when the puncture portion (220) is located in the closed position, the extension direction of the needle tip section (222) has an angle β with the central axis (OO'), satisfying: β≤45°.
11. The tissue suturing device for endoscope according to claim 1, characterized in that: The main body (210) has an assembly space (211), and the puncture part (220) is arranged in the assembly space (211) to be connected to the main body (210).
12. The tissue suturing device for endoscope according to claim 11, characterized in that: The assembly space (211) is a receiving groove (212) formed by bending the main body (210), the puncture portion (220) is embedded in the receiving groove (212), and the main body (210) clamps the puncture portion (220).
13. The tissue suturing device for endoscope according to claim 11, characterized in that: The assembly space (211) is an assembly hole (213) arranged at one end of the main body (210) away from the clamping seat (100), and the puncture portion (220) is embedded in the assembly hole (213).
14. The tissue suturing device for endoscope according to claim 11, characterized in that: The main body (210) further comprises a limiting hole (214), wherein the limiting hole (214) is in communication with the assembly space (211), and the puncture portion (220) is passed through the limiting hole (214) so as to limit the puncture portion (220) in the assembly space (211) through the limiting hole (214).
15. The tissue suturing device for endoscope according to any one of claims 11 to 14, characterized in that: The puncture portion (220) comprises: A limiting step (223) is arranged outside the assembly space (211) and connected to the main body (210), and the limiting step (223) is used to limit the position of the puncture part (220) relative to the main body (210).
16. The tissue suturing device for endoscope according to claim 15, characterized in that: The limiting step (223) is located at one end of the main body (210) away from the clamping seat (100), and the limiting step (223) includes a transition surface (2231), and the size of the transition surface (2231) increases along the direction approaching the main body (210).
17. The tissue suturing device for endoscope according to claim 1, characterized in that: The clamp arm (200) further comprises a connecting portion (230), wherein the connecting portion (230) is arranged between the main body (210) and the puncture portion (220), and the puncture portion (220) is connected to the main body (210) via the connecting portion (230).
18. The tissue suturing device for endoscope according to claim 1, characterized in that: The clamp arm (200) further comprises a receiving space (215), and the receiving space (215) is arranged on the main body (210); When the puncture portion (220) is located at the closed position, the puncture portion (220) can be embedded in the receiving space (215) of the other clamp arm (200).
19. The tissue suturing device for endoscope according to claim 1, characterized in that: The number of the puncture portion (220) of each clamp arm (200) is at least one.
20. The tissue suturing device for endoscope according to claim 1, characterized in that: The puncture portion (220) is rotatably connected to the main body (210); The tissue suturing device for endoscope also includes a driving unit (260), which is arranged in the channel (110) and connected to the puncture unit (220), and the driving unit (260) is used to drive the puncture unit (220) to rotate relative to the main body (210) so that the puncture unit (220) can approach and move away from the other clamp arm (200).
21. The tissue suturing device for endoscope according to claim 20, characterized in that: The tissue suturing device for an endoscope further comprises a driven portion (250) arranged on the puncture portion (220), the driving portion (260) being connected to the puncture portion (220) via the driven portion (250), and the driving portion (260) driving the driven portion (250) to rotate, thereby driving the puncture portion (220) to rotate relative to the main body (210).
22. The tissue suturing device for endoscope according to claim 20, characterized in that: The clamp arm (200) further includes a hinge portion (240), and the puncture portion (220) is rotatably connected to the main body (210) via the hinge portion (240). The drive portion (260) is hinged to the puncture portion (220), and the drive portion (260) moves along the channel (110) to pull the puncture portion (220) to rotate relative to the main body (210).
23. The tissue suturing device for endoscope according to claim 1, characterized in that: The puncture portion (220) is provided with a barb structure (270).
24. The tissue suturing device for endoscope according to claim 1, characterized in that: The tissue suturing device for endoscope also includes: The electrical connection portion is disposed in the channel (110) and is electrically connected to the puncture portion (220).
25. The tissue suturing device for endoscope according to claim 1, characterized in that: The tissue suturing device for endoscope also includes: A sheath tube (300) connected to the clamp seat (100), wherein the sheath tube (300) is configured to be able to be separated from the clamp seat (100) when subjected to a preset tensile force; A control line (400) is passed through the sheath tube (300) and connected to the clamp arm (200); the control line (400) is configured to be separated from the clamp arm (200) when a preset tensile force is applied.