CN113116425B - Valve Suture Devices - Google Patents
Valve Suture Devices Download PDFInfo
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- CN113116425B CN113116425B CN201911413859.4A CN201911413859A CN113116425B CN 113116425 B CN113116425 B CN 113116425B CN 201911413859 A CN201911413859 A CN 201911413859A CN 113116425 B CN113116425 B CN 113116425B
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- 239000007943 implant Substances 0.000 claims abstract description 4
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- 230000008439 repair process Effects 0.000 description 10
- 239000000463 material Substances 0.000 description 6
- 230000000149 penetrating effect Effects 0.000 description 6
- 230000035515 penetration Effects 0.000 description 4
- 210000000591 tricuspid valve Anatomy 0.000 description 4
- 238000002788 crimping Methods 0.000 description 3
- 210000002837 heart atrium Anatomy 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 210000004115 mitral valve Anatomy 0.000 description 3
- 206010027727 Mitral valve incompetence Diseases 0.000 description 2
- 229910000589 SAE 304 stainless steel Inorganic materials 0.000 description 2
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 2
- 206010044640 Tricuspid valve incompetence Diseases 0.000 description 2
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- 208000018578 heart valve disease Diseases 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0491—Sewing machines for surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06066—Needles, e.g. needle tip configurations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/062—Needle manipulators
- A61B17/0625—Needle manipulators the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00778—Operations on blood vessels
- A61B2017/00783—Valvuloplasty
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
本申请公开一种瓣膜缝线器械，包括夹持装置、固定件及穿刺装置，夹持装置包括近端夹头、远端夹头和夹头推管，夹头推管活动穿设于近端夹头并与远端夹头固定连接，夹头推管带动远端夹头相对近端夹头运动，以夹持或放松瓣膜；固定件容置于远端夹头内用于固定连接缝线，穿刺装置包括活动穿设于近端夹头的穿刺针，穿刺针包括固定相接的针头与针体，针头包括依次固定连接的针尖部、过渡部及连接部，连接部与针体固定相接，针尖部用于穿刺瓣膜并与固定件固定连接以向瓣膜植入缝线，过渡部的外径自远端向近端逐渐增大，过渡部的最大外径为针头上的最大外径，过渡部的最大外径大于针尖部的最大外径，过渡部的最大外径小于固定件的外径，使瓣膜易于被穿刺。
The present application discloses a valve suture instrument, including a clamping device, a fixing member and a puncture device, wherein the clamping device includes a proximal clamp, a distal clamp and a clamp push tube, the clamp push tube is movably inserted into the proximal clamp and fixedly connected to the distal clamp, and the clamp push tube drives the distal clamp to move relative to the proximal clamp to clamp or release the valve; the fixing member is accommodated in the distal clamp and is used to fix and connect the suture, and the puncture device includes a puncture needle movably inserted into the proximal clamp, the puncture needle includes a needle head and a needle body fixedly connected, the needle head includes a needle tip part, a transition part and a connecting part fixedly connected in sequence, the connecting part is fixedly connected to the needle body, the needle tip part is used to puncture the valve and is fixedly connected to the fixing member to implant the suture into the valve, the outer diameter of the transition part gradually increases from the distal end to the proximal end, the maximum outer diameter of the transition part is the maximum outer diameter on the needle head, the maximum outer diameter of the transition part is greater than the maximum outer diameter of the needle tip part, and the maximum outer diameter of the transition part is less than the outer diameter of the fixing member, so that the valve is easy to be punctured.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a valve suture instrument of a catheter intervention way.
Background
Heart valve disease is the result of structural damage, fibrosis, adhesion, shortening, myxomatosis, degenerative changes or congenital developmental deformity, or abnormal function or structure of a valve or valves resulting from inflammation of the heart valve (including leaflets, chordae tendineae (CT as shown in fig. 1) and papillary muscles), resulting in stenosis and insufficiency of the orifice.
Referring to fig. 1, the left atrium (LA shown in fig. 1) and the left ventricle (LV shown in fig. 1) are separated by the mitral valve (MV shown in fig. 1), the right atrium (RA shown in fig. 1) and the right ventricle (RV shown in fig. 1) are separated by the tricuspid valve (TV shown in fig. 1), and the tricuspid valve and the mitral valve allow blood to flow into the ventricles only from the atria, but not back. Mitral regurgitation or tricuspid regurgitation can cause systole ventricular blood to flow back to the atria, causing atrial volume enlargement, pressure elevation, causing ventricular loading to be exacerbated, and easily causing heart failure.
Surgery is currently the predominant method of treating heart valve disease, but is a significant surgical trauma and mortality rate for some elderly, multiple complications, or patients who have had a history of open chest surgery. At present, valve repair instruments for interventional therapy of mitral regurgitation and tricuspid regurgitation are in research and development stages, and the interventional therapy mode mainly comprises chordae tendineae repair or edge-to-edge repair by implanting suture lines into heart valves.
Referring to fig. 2, a conventional heart valve repair device 100a is inserted between ribs and then inserted into the apex of the heart, and the device is pushed into the left ventricle and left atrium to perform mitral valve repair. After the valve is pierced, the needle of the heart valve repair device 100a still needs to be advanced to enlarge the valve puncture site until the maximum diameter of the needle abuts the left atrial side suture attachment anchor. The puncture needle of the transapical instrument is rigid and straight, the thrust is easy to transmit, and the puncture point is easy to expand.
If the heart valve repair is to be performed by a more minimally invasive transcatheter intervention, the device needs to be sequentially introduced into the atrium and ventricle through the inferior vena cava or the superior vena cava, and the device needs to adapt to the curved intervention path in the vein, so that the external end of the body is pushed to expand the valve leaflet puncture point to the outer diameter of the fixing piece, and the corresponding valve puncture is difficult.
Disclosure of Invention
In order to solve the foregoing problems, the present invention provides a valve suture instrument for implanting sutures via a catheter intervention, which can make the puncture needle easier to puncture a valve.
The application discloses a valve suture instrument which is used for implanting suture into a heart valve in a catheter intervention mode and comprises a clamping device, a fixing piece and a puncture device, wherein the clamping device comprises a proximal chuck, a distal chuck and a chuck push tube; the fixing piece is accommodated in the distal chuck and is used for fixedly connecting the suture, the puncture device comprises a puncture needle movably penetrating through the proximal chuck, the puncture needle comprises a needle head and a needle body which are fixedly connected, the needle head comprises a needle tip part, a transition part and a connecting part which are sequentially and fixedly connected, the connecting part is fixedly connected with the needle body, the needle tip part is used for puncturing a valve and then is fixedly connected with the fixing piece so as to implant the suture into the valve, the outer diameter of the transition part gradually increases from the distal end to the proximal end, the maximum outer diameter of the transition part is the maximum outer diameter of the needle head, the maximum outer diameter of the transition part is larger than the maximum outer diameter of the needle tip part, and the maximum outer diameter of the transition part is smaller than the outer diameter of the fixing piece.
According to the valve suture system provided by the application, as the maximum outer diameter of the transition part of the puncture needle is the maximum outer diameter of the needle head and the maximum outer diameter of the needle head is smaller than the outer diameter of the fixing piece, when the puncture needle is pushed to puncture a valve, the puncture hole does not need to be expanded to the size of the outer diameter of the fixing piece, but is expanded to the size smaller than the outer diameter of the fixing piece, and for a catheter intervention mode, the expansion amplitude of the puncture hole is small, which means that the pushing force required to be transmitted to the needle head of the puncture needle is smaller, so that the puncture difficulty can be reduced, and the puncture needle is easier to puncture the valve.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the invention, and that other drawings can be obtained from them without inventive effort for a person skilled in the art.
Fig. 1 is a schematic diagram of a human heart structure.
Fig. 2 is a schematic view of an application scenario of a suture implantation system provided in the prior art.
Fig. 3 is a schematic perspective assembly view of a valve suture instrument according to a first embodiment of the present application.
Fig. 4 is an enlarged schematic view of the structure of the distal end of the valve suture instrument shown in fig. 3.
Fig. 5 is a cross-sectional view of the distal end of the valve suture instrument shown in fig. 3.
Fig. 6 is a partial cross-sectional view of a clamping device of the valve suture instrument shown in fig. 3.
Fig. 7 is a schematic perspective view of a puncturing device of the valve suture instrument shown in fig. 3.
Fig. 8 is an enlarged schematic view of region ii shown in fig. 7.
Fig. 9 is a schematic view of the needle of the puncturing device of the valve suture apparatus of fig. 3.
Fig. 10 is a schematic view of a valve suture instrument according to a first embodiment of the present application holding a valve.
Fig. 11 is a schematic perspective view of a suture and a fastener assembled together according to a first embodiment of the present application.
Fig. 12 is a schematic view of an application scenario of the first embodiment of the present application.
Fig. 13 is an enlarged schematic view of the local application scenario shown in fig. 12.
Fig. 14 is an enlarged schematic view of a local application scenario according to the first embodiment of the present application.
Fig. 15 is a schematic view of a first embodiment of the application when puncturing a valve.
Fig. 16 is a schematic view of a withdrawn needle, anchor and suture according to a first embodiment of the present application.
Fig. 17 is a schematic view of the needle and anchor of a valve suture apparatus according to a second embodiment of the present application.
Fig. 18 is a schematic view showing the structure of the needle head and the needle body of the valve suture apparatus according to the third embodiment of the present application.
Fig. 19 is a schematic view of the needle and anchor of a valve suture apparatus according to a third embodiment of the present application.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, based on the embodiments of the invention, which are apparent to those of ordinary skill in the art without inventive faculty, are intended to be within the scope of the invention.
In the technical field of interventional medical devices, the position close to the operator is generally defined as a proximal end, and the position away from the operator is defined as a distal end; the direction of the rotation center axis of the column, the tube, or the like is defined as the axial direction.
First embodiment
Referring to fig. 3-5 in combination, the present application provides a valve suture instrument 100 for implanting sutures 200 into a heart valve via a catheter approach to repair the heart valve. The valve suture instrument 100 includes an operating handle 10, a catheter 30, a clamping device 50, a puncturing device 70, and an adjustable curved sheath 90. The catheter 30 is fixedly connected between the holding device 50 and the operating handle 10 for feeding the holding device 50 into the heart. The operating handle 10 is used to facilitate the operator's grip to manipulate the gripping device 50 and the lancing device 70. The operating handle 10 is provided with a chuck control member 11 for controlling the opening and closing of the clamping device 50. The puncture device 70 is movably arranged in the clamping device 50, the catheter 30 and the operating handle 10 and is used for puncturing the valve to be fixedly connected with the suture 200 so as to realize the implantation of the suture 200 into the heart. The holding device 50 is used for holding a valve.
The adjustable bending sheath 90 comprises a bending handle 91 and a sheath tube 93, and the proximal end of the sheath tube 93 is fixedly connected with the bending handle 91. Catheter 30 is movably disposed through sheath 93 and bend handle 91. The bending handle 91 is used to control the distal end bending of the sheath 93, and the catheter 30 inserted into the sheath 93 can be bent in response to the bending of the sheath 93. It will be appreciated that the length of the catheter 30 is not limited.
The clamping device 50 comprises a proximal chuck 51, a distal chuck 53 and a chuck push tube 55, wherein the proximal chuck 51 is fixedly connected with the distal end of the catheter 30, the proximal chuck 51 is positioned between the distal chuck 53 and the catheter 30, the chuck push tube 55 is movably arranged on the proximal chuck 51 in a penetrating manner and is fixedly connected with the distal chuck 53, the chuck push tube 55 is movably arranged in the catheter 30 (shown in fig. 3) and the operating handle 10 (shown in fig. 3) in a penetrating manner, and the proximal end of the chuck push tube 55 is connected with the chuck control member 11 (shown in fig. 3) on the operating handle 10. The collet push tube 55 is used for driving the distal collet 53 to move under the driving of the collet control element 11, so as to control the opening and closing of the clamping device 50, and thus the distal collet 53 and the proximal collet 51 cooperate to clamp or release the valve. Distal collet 53 is also used to receive suture 200. The piercing needle 71 of the piercing device 70 is partially movably disposed within the proximal cartridge 51.
Referring to fig. 6, a puncture channel 517 for accommodating a puncture needle 71 is provided in the proximal chuck 51, and a second channel 532 for accommodating a fixing member 80 is provided in the distal chuck 53, and the second channel 532 and the puncture channel 517 are coaxially and communicatively disposed. Correspondingly, the fixing element 80 is accommodated in the second channel 532, and the fixing element 80 is substantially a circular tube. The second channel 532 is axially disposed in relation to the puncture channel 517 such that the puncture needle 71 can smoothly enter the distal collet 53 and be fixedly coupled to the fixture 80 when puncturing the distal collet 53 from the proximal collet 51. It will be appreciated that the second passage 532 and the puncturing passage 517 may not be coaxially disposed, as long as the puncturing device 70 is capable of being fixedly coupled to the securing member 80. In this embodiment, a third channel 533 is further provided at the end of distal collet 53 facing away from puncture channel 517, third channel 533 being provided in communication with second channel 532. The third channel 533 is for receiving the suture 200. The inner diameter of the third channel 533 is smaller than the inner diameter of the second channel 532, thereby forming a stepped stop structure 539 at the junction of the third channel 533 and the second channel 532. The stop structure 539 abuts the distal end of the anchor 80 to prevent the anchor 80 from moving in a direction away from the proximal collet 51, thereby improving the stability of the puncturing device 70 in puncturing the valve. It is understood that the shape and structure of the stopper 539 is not limited, for example, the third channel 533 and the second channel 532 have the same aperture, and the stopper 539 is a protrusion provided in the third channel 533.
Referring now to fig. 7 in combination, fig. 7 is a schematic perspective view of a puncturing device of the valve suture instrument of fig. 3.
The puncture device 70 includes a puncture needle 71, a puncture plunger 73, and a puncture handle 75, and the puncture plunger 73 is fixedly connected between the puncture needle 71 and the puncture handle 75. The needle 71 is movably disposed through the catheter 30 (shown in fig. 3) and the proximal chuck 51. The puncture push rod 73 is movably arranged in the catheter 30. The puncture handle 75 is movably inserted into the operation handle 10 and is protruded from the operation handle 10 (as shown in fig. 3). The puncture handle 75 is used for driving the puncture plunger 73 to move, and the puncture needle 71 punctures the valve from the proximal end to the distal end or withdraws from the valve from the distal end to the proximal end under the driving of the puncture plunger 73.
Referring to fig. 8, fig. 8 is an enlarged schematic view of the region ii shown in fig. 7.
The puncture needle 71 includes a needle 711, a distal connector 713 and a needle 714, the distal connector 713 being fixedly connected between the needle 711 and the needle 714. The needle 714 is fixedly connected with the end of the puncture push rod 73 far away from the puncture handle 75. The needle 711 is used to puncture the valve and is fixedly attached to the suture 200. The needle 714 is movably disposed through the catheter 30. In this embodiment, the needle 714 is a flexible needle, i.e., the needle 714 is capable of being forced to bend to accommodate a tortuous penetration path.
In this embodiment, the needle 714 includes a flexible needle tube 7143 and a support core 7145 that is disposed through the flexible needle tube 7143. The flexible needle tube 7143 is capable of flexing to accommodate tortuous puncture paths. In this embodiment, the support core 7145 is a nickel titanium wire. It is understood that the support core 7145 may not be limited to nickel titanium wire, but may be made of other materials having shape memory function. It will be appreciated that the support core 7145 may also be other flexible materials, such as non-metallic materials. The support core 7145 is capable of following the bending of the bendable needle tube 7143 and providing support for the bendable needle tube 7143, reducing the loss of pushing force of the puncture plunger 73 on the bendable needle body 714, and also transmitting axial force when pushing and withdrawing the plunger puncture handle 75, especially when retracting the puncture needle 71, protecting the bendable needle body 714 from tensile deformation. The distal end of the support core 7145 emerges from the flexible needle tube 7143 in fixed engagement with the distal connector 713.
In this embodiment, the flexible needle tube 7143 is a spring tube. It is understood that the flexible needle tube 7143 is not limited to a spring tube, and it is sufficient that the flexible needle tube 7143 can be bent.
In this embodiment, distal connector 713 is a sleeve and needle 711 extends into the distal end of distal connector 713 near the proximal end of distal connector 713 and is fixedly attached thereto.
In this embodiment, the length of the support core 7145 is greater than the length of the flexible needle tube 7143, and the distal end of the support core 7145 is fixedly disposed through the distal connector 713.
It will be appreciated that the support core 7145 is not limited to being fixedly disposed through the distal connector 713. For example, the support core 7145 and the distal connector 713 may be, but are not limited to, welded, threaded, etc.
It will be appreciated that the needle 711 is not limited to being fixedly disposed through the distal link 713 near an end portion of the distal link 713. For example, the end of the needle 711 near the distal connector 713 and the distal connector 713 may be, but are not limited to, welded, threaded, etc.
It will be appreciated that the distal connector 713 is not limited to being a sleeve. For example, two blind holes are respectively disposed at two ends of the distal connecting member 713, and the two blind holes are not communicated, so that the needle 711 and the supporting core 7145 are respectively and fixedly disposed through the blind holes from two ends of the distal connecting member 713.
In this embodiment, the distal link 713 is linear and rigid to reliably transmit the penetrating force, and is stable when penetrating the valve, thereby improving the stability of the valve suture instrument 100 when penetrating the valve. The rigidity of the element in the present application means that the element is not easily deformed when the element pierces a human organ such as skin or a valve in a piercing operation, for example, the needle 711 pierces a valve.
In this embodiment, the connection between the support core 7145 and the distal connector 713 is by crimping. It will be appreciated that the connection between the support core 7145 and the distal connector 713 is not limited to crimping, e.g., the connection may be, but is not limited to, threaded connection, welding, etc.
In the present embodiment, the connection between the needle 711 and the distal connector 713 is smoothly connected to the outer diameter Xiang Dangju of the distal connector 713, and the flexible needle tube 7143 is smoothly connected to the outer diameter of the distal connector 713, so that the resistance of the puncture needle 71 during the puncture is reduced.
In this embodiment, the material of the distal connector 713 may be, but is not limited to, 304 stainless steel, 316 stainless steel, or the like.
In the present embodiment, the tip of the needle 711 is required to be sharply abrasion resistant, and the tip of the needle 711 may be, but not limited to, stainless steel 304, or stainless steel 316 material, etc.
In the present embodiment, the needle 711 is subjected to a low-temperature nitriding hardening treatment, so that the needle 711 has a greater hardness.
Referring to fig. 9, the needle 711 includes a needle tip portion 7112, a step portion 7113, a transition portion 7115, a fixing portion 7116, a connecting portion 7118, and a mounting portion 7119, which are fixedly connected in this order.
The needle tip 7112 is used to puncture the valve, causing the valve to form a puncture. The outer diameter of the needle tip 7112 gradually increases from the distal end of the needle tip 7112 to the proximal end of the needle tip 7112. In this embodiment, the needle tip 7112 is generally straight conical, with the taper angle of the needle tip 7112 being less than 52 degrees so that the needle tip 7112 is sufficiently sharp to facilitate penetration of the valve. It is understood that the taper angle of the tip portion 7112 is not limited to less than 52 degrees, and may be greater than or equal to 52 degrees; the shape of the needle tip 7112 is not limited, for example, the shape of the needle tip 7112 may be, but not limited to, a beveled tip or a beveled cone, or the like.
The end of the needle tip 7112 near the step 7113 has the maximum outer diameter of the needle tip 7112. The maximum outer diameter of the tip portion 7112 is larger than the outer diameter of the stepped portion 7113, and the tip portion 7112 forms a stepped surface 7111 near one end of the stepped portion 7113. The stepped surface 7111 is adapted to fixedly attach to the anchor 80 (shown in fig. 6) to prevent the anchor 80 from being removed from the needle 711 and thereby failing to implant the suture 200.
The transition portion 7115 has an outer diameter that gradually increases from the distal end to the proximal end, and the transition portion 7115 has a maximum outer diameter that is the maximum outer diameter of the needle 711. The transition portion 7115 has a maximum outer diameter that is greater than the maximum outer diameter of the needle tip portion 7112. The maximum outer diameter of transition 7115 is denoted D1 in fig. 9. The transition portion 7115 is used to enlarge a puncture hole (not shown) formed after the puncture by the needle tip portion 7112 to a size through which the fixing member 80 (shown in fig. 6) is easily passed. The mounting portion 7119 is fixedly coupled to the distal end connection portion 713 (shown in fig. 8). In the present embodiment, the transition portion 7115 has a substantially truncated cone shape, and the taper angle of the transition portion 7115 ranges from 10 degrees to 22 degrees. The taper angle of the transition portion 7115 does not exceed 22 degrees so that the outer diameter of the transition portion 7115 changes more gently, reducing the resistance of the transition portion 7115 when it pierces the valve. The taper angle of transition portion 7115 is not less than 10 degrees to avoid too little taper, resulting in a longer length of transition portion 7115 such that needle tip 7112 pierces deeper along proximal collet 51 toward distal collet 53. It is understood that the transition portion 7115 is not limited to be a truncated cone, and it is sufficient that the maximum outer diameter of the transition portion 7115 is the maximum outer diameter of the needle 711.
The fixing portion 7116 includes a first sub-segment 7121, a second sub-segment 7123, and a third sub-segment 7125 that are sequentially and fixedly connected, wherein the first sub-segment 7121 is fixedly connected between the second sub-segment 7123 and the transition portion 7115, and the third sub-segment 7125 is fixedly connected between the second sub-segment 7123 and the connecting portion 7118. In this embodiment, the first sub-section 7121 is a cylindrical body having the same outer diameter as the maximum outer diameter D1; the second sub-section 7123 is fixedly connected between the first sub-section 7121 and the third sub-section 7125; the outer diameter of the second sub-section 7123 gradually decreases from the first sub-section 7121 toward the third sub-section 7125 (i.e., the distal end of the second sub-section 7123 is in the proximal direction) as a smooth transition of the first sub-section 7121 and the third sub-section 7125; the outer diameter of the third sub-section 7125 gradually increases from an end near the connection portion 7118 toward the second sub-section 7123 (i.e., the proximal end of the third sub-section 7125 toward the distal end) so as to smoothly transition the connection portion 7118 and the second sub-section 7123.
The outer diameter of the connecting portion 7118 is smaller than the maximum outer diameter of the transition portion 7115. In this embodiment, the connection portion 7118 is substantially cylindrical. It will be appreciated that the connection portion 7118 is not limited to be cylindrical, as long as the maximum radial dimension of the connection portion 7118 is not greater than the maximum outer diameter of the needle 711.
In the present embodiment, the mounting portion 7119 is a cylinder with an outer diameter smaller than that of the connecting portion 7118, and the needle 711 is fixedly connected to the bendable needle 714 by fixing the mounting portion 7119 to the distal end of the distal end connector 713 (shown in fig. 8). It is to be understood that the mounting portion 7119 is not limited to a cylinder, and may be, for example, but not limited to, a rectangular parallelepiped or the like. It will be appreciated that the needle 711 is not limited by securing the mounting portion 7119 through the distal connector 713, e.g., but not limited to, welding the needle 711 to the distal connector 713, etc.
The maximum outer diameter of the tip portion 7112 and the maximum outer diameter of the connecting portion 7118 are smaller than the maximum outer diameter D1 of the needle 711. It will be appreciated that the maximum outer diameter D1 of the transition 7115 determines the maximum size of the puncture hole as the needle 71 punctures the valve distally. The fixing portion 7116 is fixedly connected between the transition portion 7115 and the connection portion 7118, an outer diameter of the fixing portion 7116 near the needle tip portion 7112 is D1, and an outer diameter of the fixing portion 7116 near the mounting portion 7119 is an outer diameter of the connection portion 7118 and is smoothly connected to the connection portion 7118.
It should be noted that fig. 9 illustrates the segmented feature of the needle 711 by way of example only, and it is understood that the transition portion 7115, the fixing portion 7116, and the connecting portion 7118 may be integrally provided.
It is understood that the specific shape of the fixing portion 7116 is not limited, and it is sufficient that the transition portion 7115 and the connection portion 7118 are connected and the maximum outer diameter of the fixing portion 7116 is not greater than the maximum outer diameter. For example, the fixing portion 7116 may be a circular segment, and the outer diameter of the fixing portion 7116 may gradually decrease from the transition portion 7115 toward the connection portion 7118 (i.e., the distal end of the fixing portion 7116 toward the proximal direction).
It is understood that the structure of the fixing portion 7116 is not limited, for example, the fixing portion 7116 retains the first sub-segment 7121 and omits the second sub-segment 7123 and the third sub-segment 7125, the first sub-segment 7121 is fixedly connected between the transition portion 7115 and the connection portion 7118, and the outer diameter of the first sub-segment 7121 is not greater than the maximum outer diameter D1 of the transition portion 7115, that is, the maximum outer diameter of the fixing portion 7116 is not greater than the maximum outer diameter of the transition portion 7115.
It is understood that the step portion 7113, the fixing portion 7116, and the mounting portion 7119 may be omitted, and the connecting portion 7118 may be directly fixedly connected to the flexible needle tube 7143.
Referring to fig. 6 and 10 in combination, fastener 80 is received in second channel 532 of distal collet 53. The fixing member 80 includes a first end 81 and a second end 83 fixedly connected, the first end 81 is disposed near the proximal chuck 51, the first end 81 is configured to form a fixed connection with the needle tip 7112, and the second end 83 is fixedly connected with the suture 200. The holder 80 is provided internally with a first passage 85 for allowing the needle tip 7112 to protrude. The peripheral edge of the first end 81 is provided with a chamfer 89 for gradually expanding the puncture site as the holder 80 is withdrawn proximally by the needle 71, although being catheterized, the withdrawal tension is easier to transfer than the pushing force, so that the puncture site expansion process is easier to achieve and the holder 80 is easier to pass through the valve. The fixing member 80 further includes a buckle 87, where the buckle 87 is disposed on an inner wall of the first channel 85 and is close to the first end 81, and is used to engage with the step surface 7111 after the needle tip 711 extends into the first channel 85, so as to improve connection reliability between the fixing member 80 and the needle 711. It is understood that the buckle 87 may be a movable buckle or a buckle with elastic deformation capability.
It will be appreciated that the manner in which the second end 83 is fixedly attached to the suture 200 is not limited, and for example, the suture 200 may be threaded through the second end 83 and clamped to the second end 83 with a crimping tool, or may be, but not limited to, an adhesive attachment or the like.
In this embodiment, there is a separation distance, indicated at d in fig. 10, between the end face of the first end 81 of the mount 80 (i.e., the proximal end face of the mount 80) and the opening of the second channel 532 near the proximal collet 51 (i.e., the proximal end face of the distal collet 53 or the gripping face of the distal collet 53 and the valve). In this embodiment, the distance d is 0.15mm, so that the needle tip 7112 pushes and pierces the valve (indicated by V in fig. 10) before entering the fixing member 80, so that the valve is prevented from being pushed into the inner cavity of the fixing member 80 by the needle 711 without being pierced by the needle 711, and the engagement between the needle 711 and the fixing member 80 is affected, thereby further improving the connection reliability between the fixing member 80 and the needle 711.
It will be appreciated that the spacing distance d between the end surface of the first end 81 of the securing member 80 and the opening of the second channel 532 proximate the proximal collet 51 (i.e., the gripping surface of the distal collet and the valve) is sufficient to be greater than or equal to 0.10 mm. For example, the separation distance d between the end surface of the first end 81 of the securing member 80 and the opening of the second channel 532 proximate the proximal collet 51 (i.e., the gripping surface of the distal collet 53 and the valve) may be, but is not limited to, 0.17mm, 0.20mm, 0.21mm, etc.
It will be appreciated that the snap-fit engagement of the needle 711 with the mount 80 is non-removable or removable. It will be appreciated that the needle 711 is not limited to a snap-fit engagement with the mount 80.
As shown in fig. 10, the outer diameter of the fixing member 80 is denoted as D2, the inner diameter of the first channel 85 is denoted as D3, and the difference between the outer diameter D2 of the fixing member 80 and the maximum outer diameter D1 of the transition portion 7115 is in the range of 0.1 to 0.2mm, and in this embodiment, the maximum outer diameter D1 of the transition portion 7115 is 0.10mm smaller than the outer diameter D2 of the fixing member 80. It is understood that the range of the difference between the outer diameter D1 of the mount 80 and the outer diameter D2 of the mount 80 is not limited.
In the present embodiment, the maximum outer diameter D1 of the transition portion 7115 is larger than the inner diameter D3 of the first channel 85 of the fixing element 80, so that when the step surface 7111 of the puncture needle 7112 is engaged with the catch 87 of the fixing element 80, the transition portion 7115 is blocked by the proximal end surface of the fixing element 80, and a certain gap is provided between the transition portion 7115 and the inner cavity of the fixing element 80 in the radial direction.
It should be understood that the structure of the needle 711 is not limited, the structure and shape of the fixing member 80 are not limited, and the maximum outer diameter D1 of the transition portion 7115 may be smaller than the maximum outer diameter D2 of the fixing member 80.
Referring to fig. 10 and 11 in combination, in the present embodiment, the suture 200 includes a first fixed end 201, a second fixed end 203, and a main body 205. The body 205 is fixedly coupled between the first and second fixed ends 201 and 203. The first fixing end 201 and the second fixing end 203 are fixedly connected with one fixing member 80 respectively. In this embodiment, suture 200 is received within distal clip 53.
In this embodiment, the main body 205 is bent into a "U" shape, two ends after bending are the first fixing end 201 and the second fixing end 203, and the rest is the main body 205.
In this embodiment, the gasket 209 is disposed on the suture 200, and two through holes 2091 are disposed on the gasket 209 to allow the first fixing end 201 and the second fixing end 203 to pass through respectively, and the gasket 209 is used to increase the contact area between the bending portion of the main body 205 and the valve, so as to reduce the damage to the valve.
In the present embodiment, the pad 209 has a curvature protruding toward the bending portion of the main body 205, so that the pad 209 can be more favorably attached to the valve. It will be appreciated that the curvature of the pad 209 is preferably such that it fits the valve to the greatest extent.
It is understood that the material of the pad 209 is not limited, and for example, the material of the pad 209 may be, but not limited to, polyester cloth, polytetrafluoroethylene (PTFE), polyester resin (Polyethylene terephthalate PET), and the like. It will be appreciated that the shape of the spacer 209 is not limited. It will be appreciated that the spacer 209 may be omitted.
As shown in fig. 12 and 13, in an application scenario, the valve suture apparatus 100 provided by the present application is used for transcatheter tricuspid valve repair, where femoral vein (CFV as shown in fig. 12) opening is first performed, and the holding device 50 is sequentially delivered to the right atrium (RA as shown in fig. 12) and the right ventricle (RV as shown in fig. 12) via the inferior vena cava (IVC as shown in fig. 12) to reach the tricuspid valve position.
After the distal chuck 53 and the proximal chuck 51 clamp the valve under the action of the chuck control 11, the puncture push rod 73 is driven by the puncture handle 75, and the puncture push rod 73 drives the puncture needle 71 to move so that the puncture needle 71 punctures the valve and withdraws.
When the needle 711 of the puncture needle 71 punctures the valve, it is not the tip of the needle 711 that contacts the valve, which would puncture the valve. Due to the flexibility of the valve itself, the process of puncturing the valve and retracting the needle 711 can be understood as:
As shown in fig. 14, first, the needle 711 pushes the valve in the direction of the distal collet 53 (V shown in fig. 14), the valve is pushed into the distal collet 53 by the needle 711, and at this time the valve is supported in a substantially tent shape, and the valve is pierced to form a puncture hole (H shown in fig. 14).
As shown in fig. 15, the needle 711 continues to pierce the push-open buckle 87, and as the needle 711 advances gradually toward the distal end, the piercing hole on the valve gradually expands to the size of the maximum outer diameter D1 of the transition portion 7115 along with the truncated cone surface of the transition portion 7115, and the stepped surface 7111 of the needle 711 is blocked by the buckle 87, so as to realize the fixed connection between the needle 711 and the fixing member 80. The penetration is a movement in a direction from the proximal collet 51 to the distal collet 53.
As shown in fig. 16, suture 200 is withdrawn through the valve (V shown in fig. 16) by needle 711, chamfer 89 of anchor 80 secondarily enlarges the puncture hole, gradually enlarging the outer diameter of the puncture hole from D1 to D2, and suture 200 is thus implanted on the valve. The retraction is a movement in a direction from distal collet 53 to proximal collet 51. The suture on each valve leaflet can be locked later to realize edge-to-edge repair.
In the prior art, since the maximum outer diameter of the puncture needle is equal to or greater than the outer diameter of the fixing member, the puncture hole generated after the puncture needle passes through the valve is eventually enlarged to be greater than or equal to the outer diameter of the fixing member, and the required puncture force is large. In this embodiment, the puncture hole is finally widened to be equal to the outer diameter of the fastener in two times. The first expansion of the puncture is a puncture formed by the distal penetration of the needle tip 7112, and the transition 7115 of the needle 711 is passed through the puncture, so that the outer diameter of the puncture is the maximum outer diameter D1 of the needle 711. The second enlarging of the puncture hole is that the needle 711 drives the fixing member 80 to pierce proximally, so that the fixing member 80 passes through the puncture hole, and the outer diameter of the puncture hole is enlarged from D1 to the outer diameter D2 of the fixing member 80. In this embodiment, the difference between the outer diameters D1 and D2 is small, and the chamfer 89 of the anchor 80 gradually enlarges the outer diameter of the puncture hole from D1 to D2 twice, making it easier for the anchor 80 to pass through the valve. Because of the flexibility of the valve, the needle 71 is driven to retract by applying a pulling force, which is more easily transmitted and more easily accomplished in the curved catheter 30 than in the prior art where the needle 71 is pushed.
Second embodiment
Referring to fig. 17, the valve suture apparatus provided in the second embodiment is similar to the valve suture apparatus provided in the first embodiment in structure, and the needle 611 includes a needle tip portion 6112, a step portion 6113, a transition portion 6115, a fixing portion 6116, a connecting portion 6118, and a mounting portion 6119, which are sequentially and fixedly connected, wherein the fixing portion 6116 is substantially in a cylindrical structure, and an outer diameter of the connecting portion 6118 is the same as a maximum outer diameter (denoted as D1 in fig. 17) of the transition portion 6115.
Third embodiment
Referring to fig. 18 in combination, the valve suture apparatus provided in the third embodiment is similar to the valve suture apparatus provided in the second embodiment in structure, and is different in that the needle 811 provided in the third embodiment includes a needle tip portion 8112, a transition portion 8115 and a connection portion 8119 that are fixedly connected in sequence, wherein the transition portion 8115 includes a first sub-section 8121 and a second sub-section 8123 that are fixedly connected, the first sub-section 8121 is fixedly connected between the second sub-section 8123 and the needle tip portion 8112, the first sub-section 8121 and the second sub-section 8123 are both substantially in a truncated cone structure, the maximum outer diameter of the first sub-section 8121 is smaller than the maximum outer diameter of the second sub-section 8123, the second sub-section 8123 has the maximum outer diameter of the needle 811 (denoted as D1 in fig. 18), and the outer diameters of the first sub-section 8121 and the second sub-section 8123 are both gradually reduced in a distal direction toward the proximal direction; the maximum outer diameter of the connection 8119 is the same as the maximum outer diameter of the second sub-section 8123.
Needle 811 omits the step and the connection.
The distal end of the supporting inner core 8145 of the needle body 814 is fixedly penetrated through the connecting portion 8119, so that the needle body 814 is fixedly connected with the needle 811.
Referring to fig. 19 in combination, fig. 19 is a schematic structural view of a needle and a fixing member of a valve suture apparatus according to a third embodiment of the present application, where an axial direction of the needle 711 corresponds to an axial direction of a first channel in the fixing member 80.
The foregoing disclosure is merely illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the claims herein, as equivalent changes to the claims herein fall within the scope of the invention.
Claims (12)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911413859.4A CN113116425B (en) | 2019-12-31 | 2019-12-31 | Valve Suture Devices |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911413859.4A CN113116425B (en) | 2019-12-31 | 2019-12-31 | Valve Suture Devices |
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| Publication Number | Publication Date |
|---|---|
| CN113116425A CN113116425A (en) | 2021-07-16 |
| CN113116425B true CN113116425B (en) | 2024-11-19 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201911413859.4A Active CN113116425B (en) | 2019-12-31 | 2019-12-31 | Valve Suture Devices |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN211934165U (en) * | 2019-12-31 | 2020-11-17 | 杭州德晋医疗科技有限公司 | Valve suture instrument |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4447658C2 (en) * | 1994-05-28 | 1996-12-19 | Karlsruhe Forschzent | Thread for constructing surgical seam |
| US6997931B2 (en) * | 2001-02-02 | 2006-02-14 | Lsi Solutions, Inc. | System for endoscopic suturing |
| US7364541B2 (en) * | 2001-03-09 | 2008-04-29 | Boston Scientific Scimed, Inc. | Systems, methods and devices relating to delivery of medical implants |
| US6911003B2 (en) * | 2002-03-07 | 2005-06-28 | Ams Research Corporation | Transobturator surgical articles and methods |
| US7909753B1 (en) * | 2005-10-05 | 2011-03-22 | Ams Research Corporation | Connector for mesh support insertion |
| CN110313947B (en) * | 2018-03-28 | 2024-07-02 | 杭州德晋医疗科技有限公司 | Heart valve repair system |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN211934165U (en) * | 2019-12-31 | 2020-11-17 | 杭州德晋医疗科技有限公司 | Valve suture instrument |
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