WO2022237037A1 - 夹持器械 - Google Patents
夹持器械 Download PDFInfo
- Publication number
- WO2022237037A1 WO2022237037A1 PCT/CN2021/119287 CN2021119287W WO2022237037A1 WO 2022237037 A1 WO2022237037 A1 WO 2022237037A1 CN 2021119287 W CN2021119287 W CN 2021119287W WO 2022237037 A1 WO2022237037 A1 WO 2022237037A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- clamping
- arm
- seat
- main
- locking structure
- Prior art date
Links
- 210000003709 heart valve Anatomy 0.000 claims description 9
- 230000009471 action Effects 0.000 claims description 6
- 238000005452 bending Methods 0.000 claims description 6
- 230000005489 elastic deformation Effects 0.000 claims description 6
- 230000002441 reversible effect Effects 0.000 claims description 6
- 238000010586 diagram Methods 0.000 description 7
- 230000008439 repair process Effects 0.000 description 6
- 238000013459 approach Methods 0.000 description 5
- 230000007423 decrease Effects 0.000 description 5
- 210000005246 left atrium Anatomy 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 210000005240 left ventricle Anatomy 0.000 description 4
- 210000004115 mitral valve Anatomy 0.000 description 4
- 206010019280 Heart failures Diseases 0.000 description 2
- 206010067171 Regurgitation Diseases 0.000 description 2
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 2
- 206010044640 Tricuspid valve incompetence Diseases 0.000 description 2
- 210000004763 bicuspid Anatomy 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 210000000591 tricuspid valve Anatomy 0.000 description 2
- 241000758794 Asarum Species 0.000 description 1
- 206010020880 Hypertrophy Diseases 0.000 description 1
- 206010057500 Left atrial hypertrophy Diseases 0.000 description 1
- 206010037368 Pulmonary congestion Diseases 0.000 description 1
- 206010057501 Right atrial hypertrophy Diseases 0.000 description 1
- 206010039163 Right ventricular failure Diseases 0.000 description 1
- 208000000924 Right ventricular hypertrophy Diseases 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 210000001765 aortic valve Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 238000007675 cardiac surgery Methods 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000003205 diastolic effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000013013 elastic material Substances 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 208000002815 pulmonary hypertension Diseases 0.000 description 1
- 210000003102 pulmonary valve Anatomy 0.000 description 1
- 210000003492 pulmonary vein Anatomy 0.000 description 1
- 238000010992 reflux Methods 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 230000001839 systemic circulation Effects 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
Definitions
- the embodiments of the present application relate to the technical field of medical devices, in particular to a clamping device.
- Mitral valve, tricuspid valve, aortic valve, pulmonary valve and other common diseases are valvular insufficiency.
- mitral valve Taking the mitral valve as an example, during systole, part of the blood of the left ventricle flows to the left atrium through the insufficient mitral valve orifice. reflux.
- the left atrium receives blood from the left ventricular regurgitation and blood from the pulmonary vein at the same time, and the blood volume and pressure of the left atrium increase significantly, resulting in left atrial hypertrophy.
- the present application provides a clamping instrument that can provide reliable clamping force and is suitable for clamping different target tissues.
- the present application provides a clamping device, which includes a locking structure, which can be switched between a locked state and an unlocked state; and a plurality of clamping structures, each of which is connected to the lock
- the clamping structure can be linked with the switching action of the locking structure to adjust the clamping angles formed by each clamping structure; wherein, each clamping angle formed by adjusting each clamping structure angle, so that each clamping structure clamps or releases each target tissue; and wherein, when the locking structure is in the locking state, the locking structure can exert force on each clamping structure
- the continuous resisting force keeps the clamping angles formed by the clamping structures to a minimum, thereby clamping the target tissues.
- each of the clamping structures is respectively used to clamp target tissues; the target tissues include heart valves.
- the clamping instrument further includes a mandrel
- the locking structure includes a clamping seat and an adjusting seat coaxially arranged on the mandrel, each of the clamping structures is respectively connected to the clamping seat and the adjusting seat; wherein, when the locking structure is gradually switched from the unlocked state to the locked state, the distance between the clamping seat and the adjusting seat is gradually reduced, each The pivot angle between the clamping structure and the mandrel is gradually reduced.
- the clamping seat is movably arranged on the mandrel and can move back and forth along the axial direction of the mandrel; the adjusting seat is fixed on the mandrel.
- the locking structure further includes a first buckle and a second buckle respectively disposed on the clamping seat and the adjustment seat; wherein, the first buckle and the second buckle The two buckles can be engaged with each other, so that the locking structure is maintained in the locked state; and wherein, after the first buckle and the second buckle are engaged with each other, the At least a portion of the mandrel may remain in the holding instrument, or the mandrel may be completely withdrawn from the holding instrument.
- each of the clamping structures includes a main clamping arm, an auxiliary clamping arm and an elastic arm; the main clamping arm and the auxiliary clamping arm are respectively pivoted to the clamping seat, and the opposite two sides of the elastic arms
- the adjustment seat and the main clamp arm are respectively pivotally connected; wherein, when the locking structure performs the switching action between the locked state and the unlocked state, the clamping seat and the The distance between the adjustment seats can be increased or reduced, so as to drive each of the main clip arms to pivot relative to the clamping seats via the elastic arm; when the locking structure is maintained in the locked state
- a continuous elastic resisting force can be applied to each of the main clamping arms through each of the elastic arms, so as to urge each of the main clamping arms to pivot in a direction close to the auxiliary clamping arm relative to the clamping seat, so that The clamping angle formed between the primary clamp arm and the secondary clamp arm is kept to a minimum.
- the main clamping arm can apply a reverse force to the elastic arm according to the thickness of the target tissue, so that the elastic arm produces different degree of elastic deformation until the elastic resisting force of the elastic arm reaches a balance with the opposing force of the main clip arm.
- the elastic arm includes at least one of an arcuate bent portion, an S-shaped bent portion, and a Z-shaped bent portion.
- each of the main clamping arms and/or the auxiliary clamping arms can be coaxially or non-coaxially pivoted to the clamping seat.
- the auxiliary clamping arm can be elastically deformed under a stressed state to pivot relative to the clamping seat in a direction away from the main clamping arm, so that the The clamping angle between the main clamping arms is increased; the auxiliary clamping arm can be elastically restored in a non-stressed state to pivot relative to the clamping seat in a direction close to the main clamping arm, so that the forming The clamping angle between the auxiliary clamp arm and the main clamp arm becomes smaller.
- the auxiliary clamping arm includes a clamping part and a pivoting part, and the clamping part can be pivotally connected to the mandrel or the clamping seat via the pivoting part; the pivoting part can be Elastically deform in a stressed state and elastically recover in a non-stressed state for the clamping portion to pivot relative to the clamping seat.
- each of the auxiliary clamping arms has an integrated structure or a separate structure.
- the clamping instrument of the embodiment of the present application applies a continuous thrust force to the clamping structure by means of the locking structure in the locked state, so that the clamping angle formed by each clamping structure is kept to a minimum, For the clamping structure to maintain a reliable and stable clamping force.
- the main clamping arm of the clamping structure can apply a reverse force to the elastic arm according to the thickness of the target tissue, so that the elasticity can be different. Elastic deformation to a certain degree until the elastic resisting force of the elastic arm reaches a balance with the opposing force of the main clamp arm.
- the clamping structure is suitable for clamping target tissues of different thicknesses.
- FIG. 1A to FIG. 1B are schematic three-dimensional structure diagrams of different embodiments of the clamping instrument of the present application.
- Fig. 2 is a schematic diagram of an exploded structure of the clamping device of the present application.
- FIG. 3 and FIG. 4 are structural schematic diagrams of the locking structure of the clamping instrument of the present application in an unlocked state and a locked state, respectively.
- Fig. 5 and Fig. 6 are side cross-sectional views of the locking structure of the clamping instrument of the present application in an unlocked state and a locked state, respectively.
- FIG. 7 and 8 are partial schematic diagrams of the adjusting seat and the clamping seat of the present application, respectively.
- 9 and 10 are partial schematic diagrams of the auxiliary clamping arms of the present application, respectively.
- Fig. 11 and Fig. 12 are respectively schematic diagrams of different embodiments of the clamping instrument of the present application.
- Fig. 13 to Fig. 17 are schematic diagrams of embodiments of heart leaflet repair operation performed by using the clamping instrument of the present application.
- 10 Clamping device; 20: Mandrel; 22: Connection interface: 30: Locking structure; 32: Clamping seat; 322: Pivoting shaft; 324: Piercing slot; 34: Adjusting seat; 342: Pivoting hole ;36: first buckle; 38: second buckle; 40: clamping structure; 42: main clamp arm; 422: top pivot hole; 424: middle pivot hole; 44: elastic arm; 442: 444: the second pivot hole; 46: the auxiliary clip arm; 462: the clamping part; 464: the pivot part. 466: piercing part; 52: pivot shaft; 54: pivot shaft; 60: target tissue; 70: delivery system; 80: pull wire.
- the clipping device 10 of this embodiment can be used as an edge-to-edge repair implant in the field of interventional treatment of structural heart disease, and it can reach a designated anatomical position through a minimally invasive transvascular approach or transatrial appendage to achieve heart leaflet repair. .
- the clamping instrument 10 of the present application mainly includes a locking structure 30 and a plurality of clamping structures 40 .
- the locking structure 30 can switch between a locked state and an unlocked state.
- Each clamping structure 40 is connected to the locking structure 30 and can be linked with the switching action of the locking structure to adjust the clamping angles formed by each clamping structure 40 .
- each clamping angle formed by each clamping structure 40 can be adjusted so that each clamping structure 40 can clamp or release each target tissue.
- each clamping structure 40 when the locking structure 30 is in the locked state, the locking structure 30 can apply a continuous thrust force to each clamping structure 40, so that the clamping angle formed by each clamping structure 40 can be kept to a minimum. Therefore, each clamping structure 40 is provided to maintain a stable clamping force to clamp each target tissue (that is, the state shown in FIG. 4 and FIG. 6 ).
- the target tissue is, for example, a heart valve, including but not limited to a mitral valve, a tricuspid valve, and the like.
- the clamping instrument 10 may also include a mandrel 20 (refer to FIG. 1B ), and the locking structure 30 may include a clamping seat 32 and an adjusting seat 34 coaxially arranged on the mandrel 20, wherein each clamping structure 40 are connected to the clamping seat 32 and the adjusting seat 34 respectively.
- the distance between the clamping seat 32 and the adjusting seat 34 is gradually reduced, so that the distance between each clamping structure 40 and the mandrel 20
- the pivot angle gradually decreases thereupon, that is, the free end of the clamping structure 40 moves toward the direction close to the mandrel 20 (refer to the state shown in FIG.
- the clamping seat 32 can be movably arranged on the mandrel 20 (for example, it can be movably passed through the mandrel 20), and the adjusting seat 34 can be fixed at the end of the mandrel 20, and the clamping seat can be used to 32 reciprocates along the axial direction of the mandrel 20 to adjust the distance between the clamping seat 32 and the adjusting seat 34 , and then drives the clamping structure 40 to pivot relative to the mandrel 20 .
- the locking structure 30 may further include a first locking member 36 and a second locking member 38 respectively disposed on the clamping seat 32 and the adjusting seat 34 (refer to FIG. 7 and FIG. 8 ).
- first buckle 36 and the second buckle 38 can be engaged with each other to maintain the locking structure 30 in a locked state.
- the first buckle 36 may include two hooks disposed on opposite sides of the adjustment seat 34
- the second buckle 38 may include two hooks disposed on opposite sides of the clamping seat 32 . card slot.
- the first buckle 36 and the second buckle 38 can also be realized by using other buckle structures, which is not limited in this application.
- the mandrel 20 is a detachable structural design, which is mainly used to provide axial positioning between the clamping seat 32 and the adjusting seat 34 during the clamping instrument 10 performing the clamping process of the target tissue. It is used for position alignment between the first buckle part 36 and the second buckle part 38 and the engaging operation.
- the mandrel 20 can be selected to be completely withdrawn from the clamping device 10 according to actual use requirements (refer to FIG. 1A ). state shown), or choose to completely indwell the mandrel 20 in the clamping instrument 10 to further improve the clamping stability of the clamping instrument 10 (refer to the state shown in FIG. 1B ).
- the mandrel 20 can be designed as a component fixed in the clamping instrument 10 .
- a part of the delivery system can also be used as the mandrel 20 of the clamping device 10 to assist the clamping device 10 to perform the clamping operation of the target tissue, and after the clamping operation of the target tissue is completed, the mandrel 20 can be detached from holding device 10 and removed with the delivery system.
- connection interface 22 can also be designed on the mandrel 20, so that the holding device 10 can be detachably connected to the delivery system (Refer to the detailed description below regarding FIGS. 13 to 17).
- each clamping structure 40 includes a main clamping arm 42 , an elastic arm 44 , and an auxiliary clamping arm 46 .
- each main clamping arm 42 and each auxiliary clamping arm 46 can be pivotally connected to the clamping seat 32 , and opposite ends of each elastic arm 44 are respectively pivotally connected to the adjusting seat 34 and the main clamping arm 42 .
- the top pivot holes 422 of each main clamp arm 42 are pivotally connected to the pivot shaft 322 of the clamping seat 32 , and first pivot holes are respectively provided at opposite ends of each elastic arm 44 .
- the connection hole 442 and the second pivot hole 444 wherein the first pivot hole 442 of the elastic arm 44 is pivotally connected with the middle pivot hole 424 of the main clamp arm 42 via the pivot shaft 52, and the second pivot hole 44 of the elastic arm 44 is pivotally connected.
- the hole 444 is pivotally connected to the pivot hole 342 of the adjustment base 34 via the pivot shaft 54 .
- each main clamping arm 42 can be driven to pivot relative to the clamping base 32 via the elastic arm 44, so that each main clamping arm Each pivot angle between 42 and the mandrel 20 gradually decreases (refer to the state shown in FIG.
- a continuous elastic resisting force can be applied to each main clamp arm 42 through each elastic arm 44 to promote each main clamp arm 42 to approach the auxiliary clamping arm 42 relative to the clamping seat 32 .
- the direction of the clamping arm 46 is pivoted so that the clamping angle formed between the main clamping arm 42 and the auxiliary clamping arm 46 is kept to a minimum.
- the main clamping arm 42 can also apply a reverse force to the elastic arm 44 according to the thickness of the target tissue it clamps, so that the elastic arm 44 produces different degrees of elastic deformation. , until the elastic resisting force of the elastic arm 44 and the opposing force of the main clamp arm 42 reach a balance.
- the main clamping arms 42 and the elastic arms 44 can be adaptively adjusted according to the actual thickness of the currently clamped target tissue, so that each main clamping arm 42 and the mandrel 20 to form different minimum pivoting angles, this design can not only provide the clamping instrument 10 of the present application suitable for clamping target tissues of different thicknesses, but also ensure that target tissues of various thicknesses can be effectively clamped, Thereby further improving the success rate of heart leaf valve repair surgery.
- the elastic arm 44 includes an S-shaped bending portion (refer to FIG. 1 to FIG. 6 ), an arcuate bending portion (refer to FIG. 11 ) or a Z-shaped bending portion (refer to FIG. 12 ).
- the above-mentioned elastic arm 44 may also be realized by using a spring structure (not shown).
- the elastic arm 44 can be made of nickel-titanium alloy material, but not limited thereto, and can also be made of other elastic materials, which is not limited in this application.
- each main clamping arm 42 of each clamping structure 40 may be connected to the clamping seat 32 in a coaxial pivotal manner or a non-coaxial pivotal manner.
- auxiliary clamping arm 46 and the main clamping arm 42 can pivot independently relative to the clamping seat 32 to adjust the clamping angle formed between the auxiliary clamping arm 46 and the main clamping arm 42, so as to clamp Hold or release target tissue (e.g. heart valves).
- Hold or release target tissue e.g. heart valves
- the auxiliary clamp arm 46 can be elastically deformed in a stressed state, so as to pivot in a direction away from the main clamp arm 42 relative to the clamp seat 32, so that a The clamping angle increases; the auxiliary clamp arm 46 can also be elastically restored in a non-stressed state, so as to pivot toward the direction close to the main clamp arm 42 relative to the clamp seat 32, so that the clamping arm 46 formed on the main clamp arm 46 and the main The clamping angle between the clamping arms 42 becomes smaller.
- the auxiliary clamping arm 46 may include a clamping portion 462 and a pivot portion 464 , wherein the clamping portion 462 may be pivotally connected to the clamping seat 32 via the pivotal portion 464 .
- each auxiliary clamping arm 46 of each clamping structure 40 can be designed as an integral structure or as a separate structure.
- each auxiliary clamping arm 46 of each clamping structure 40 is an integrated design structure, and each auxiliary clamping arm 46 can pass through the core through the piercing part 466. on the shaft 20, and each clamping portion 462 of each auxiliary clamping arm 46 can extend outwards through each piercing groove 324 of the clamping seat 32, and pivot relative to the clamping seat 32 using each piercing groove 324 as a rotating shaft (Refer to Figure 2, Figure 8).
- auxiliary clamp arm 46 is not limited to that shown in the drawings of this application, those skilled in the art can adopt any other equivalent design scheme under the technical inspiration of this application, and this application does not make any limit.
- the pivoting portion 464 can be elastically deformed under a stressed state, so that the clamping portion 462 can pivot relative to the clamping seat 32 in a direction away from the main clamping arm 42, so that the main clamping arm 42 and the auxiliary clamping
- the clamping angle between the arms 46 (clamping portion 462 ) increases; alternatively, the pivotal portion 464 can also be elastically restored in a non-stressed state, so that the clamping portion 462 approaches the main clamp relative to the clamping seat 32
- the direction of the arm 42 is pivoted, so that the clamping angle between the main clamping arm 42 and the auxiliary clamping arm 46 (clamping portion 462 ) becomes smaller for clamping the target tissue.
- the free end of the auxiliary clamp arm 46 can be connected to a driver (such as a pull wire 80), and the free end of the auxiliary clamp arm 46 can be pulled by the driver to make the auxiliary clamp arm
- the pivoting portion 464 of 46 is elastically deformed (refer to FIG. 10 ) for the clamping portion 462 to pivot relative to the clamping seat 32 , so that the clamping angle between the auxiliary clamping arm 46 and the main clamping arm 42 increases.
- the pivotal portion 464 of the auxiliary clamping arm 46 is elastically recovered (refer to FIG. 9 ), so that the clamping portion 462 can pivot relative to the clamping seat 32, so that the auxiliary clamping arm 46 and the main clamping arm 46 can be connected to each other.
- the clamping angle between the clamping arms 42 becomes smaller.
- Fig. 13 to Fig. 17 exemplarily describe the method of using the clamping instrument 10 of the present application to perform heart valve repair treatment.
- the clamping instrument 10 is delivered to the vicinity of the target tissue 60 (eg, heart valve) to be repaired by the delivery system 70 (refer to FIG. 13 ).
- the target tissue 60 eg, heart valve
- the adjustment seat 34 of the clamping instrument 10 is controlled by the delivery system 70 to move in the distal direction relative to the clamping seat 32, so that the distance between the adjustment seat 34 and the clamping seat 32 increases, and then the main clamping arm is driven through the elastic arm 44 42 pivots relative to the clamping seat 32 to open, that is, the pivot angle between the main clamp arm 42 and the mandrel 20 increases, and for example, the pull wire 80 connected to the auxiliary clamp arm 46 is aimed at the auxiliary clamp arm 46 Applying a pulling force to keep the auxiliary clamp arm 46 close to the opposite sides of the mandrel 20, so that the clamping angle between the main clamp arm 42 and the auxiliary clamp arm 46 remains large enough to provide the target tissue to be repaired.
- 60 eg, a heart valve
- 60 is positioned between primary clamp arm 42 and secondary clamp arm 46 (see FIG. 14 ).
- the auxiliary clip arm 46 pivots relative to the clamp seat 32 toward the main clamp arm 42 under the action of the elastic restoring force, so that the target tissue 60 (such as a heart valve) is clamped in the main clamp Between the arm 42 and the auxiliary clamp arm 46 (refer to FIG. 15 ).
- the auxiliary clamping arm 46 can be pulled again through the pull wire 80 to release the clamping between the auxiliary clamping arm 46 and the main clamping arm 42.
- the target tissue 60 in between, and capture the target tissue 60 again, until the clamping state of the target tissue 60 meets expectations.
- the adjustment seat 34 of the clamping instrument 10 is controlled to move proximally relative to the clamping seat 32 through the delivery system 70, so that the distance between the adjustment seat 34 and the clamping seat 32 is reduced, and then the main clamp is driven through the elastic arm 44
- the arm 42 pivots in the opposite direction relative to the clamping seat 32, so that the pivot angle between the main clamp arm 42 and the mandrel 20 gradually decreases, and drives the auxiliary clamp arm 46 to gradually move toward the mandrel 20. Close together until the adjusting seat 34 and the clamping seat 32 engage with each other, that is, the locking structure 30 is in a locked state.
- the auxiliary clamping arm 46 will be pressed against the clamping seat 32 by the push force of the main clamping arm 42, and at the same time, the main clamping arm 42 can also According to the different thicknesses of the clamped target tissue 60, a reverse force is applied to the elastic arm 44, so that the elastic arm 44 produces different degrees of elastic deformation, until the elastic resisting force applied by the elastic arm 44 to the main clamping arm 42 matches the main clamping force.
- the opposing force exerted by the arm 42 on the elastic arm 44 is balanced, so as to ensure that the target tissue 60 can be stably and firmly clamped between the main clamping arm 42 and the auxiliary clamping arm 46 .
- the delivery system 70 and the clamping device 10 are separated from each other, so that the delivery system 70 is withdrawn, and only the clamping device 10 remains in the patient's body, so as to complete the clamping operation of the target tissue 60 (such as a heart valve).
- the target tissue 60 such as a heart valve
- the clamping instrument provided by this application applies a continuous thrust force to the clamping structure by means of the locking structure in the locked state, so as to keep the clamping angle formed by each clamping structure to a minimum, so that the clamping
- the structure can maintain a stable and reliable clamping force, so as to improve the clamping effect and improve the success rate of the treatment of bicuspid and tricuspid regurgitation.
- the main clamping arm of the clamping structure can also apply a reverse force to the elastic arm according to the actual thickness of the target tissue it clamps, so that the elastic arm produces different degrees of elastic deformation until the elastic resistance of the elastic arm
- the pushing force is balanced with the opposing force of the main clamping arm, so that it is suitable for clamping target tissues of different thicknesses.
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- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Veterinary Medicine (AREA)
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Abstract
Description
Claims (12)
- 一种夹持器械,其特征在于,包括:锁紧结构,其可在锁紧状态和非锁紧状态之间切换作动;以及多个夹持结构,各所述夹持结构分别连接所述锁紧结构并可随所述锁紧结构的所述切换作动产生联动,以调节各所述夹持结构形成的各夹合角度;其中,通过调节各所述夹持结构形成的各所述夹合角度,以供各所述夹持结构夹持或释放各目标组织;且其中,当所述锁紧结构处于所述锁紧状态时,所述锁紧结构可向各所述夹持结构施加持续的抵推力,使得各所述夹持结构所形成的各所述夹合角度维持最小化,从而夹紧各所述目标组织。
- 根据权利要求1所述的夹持器械,其特征在于,所述目标组织包括心脏瓣膜。
- 根据权利要求2所述的夹持器械,其特征在于,所述夹持器械还包括芯轴,所述锁紧结构包括共轴设于所述芯轴上的夹持座和调节座,各所述夹持结构分别连接所述夹持座和所述调节座;其中,当所述锁紧结构逐渐由所述非锁紧状态切换至所述锁紧状态时,所述夹持座和所述调节座之间的间隔距离逐渐缩小,各所述夹持结构与所述芯轴之间的枢转角度逐渐减小。
- 根据权利要求3所述的夹持器械,其特征在于,所述夹持座可活动地设于芯轴上并沿可芯轴的轴向往复移动;所述调节座固设于所述芯轴上。
- 根据权利要求4所述的夹持器械,其特征在于,所述锁紧结构还包括分设于所述夹持座和所述调节座上的第一卡扣件和第二卡扣件;其中,所述第一卡扣件和所述第二卡扣件可相互卡合,以使所述锁紧结构维持于所述锁紧状态;且其中,在所述第一卡扣件和所述第二卡扣件完成相互卡合后,所述芯轴的至少一部分可留置于所述夹持器械中,或者,所述芯轴可完全从所述夹持器械中撤离。
- 根据权利要求5所述的夹持器械,其特征在于,各所述夹持结构各自包括主夹臂、辅夹臂和弹性臂;所述主夹臂和所述辅夹臂分别枢接所述夹持座,所述弹性臂的相对两端分别枢接所述调节座与所述主夹臂;其中,当所述锁紧结构在所述锁紧状态和所述非锁紧状态之间执行所述切换作动时,所述夹持座和所述调节座之间的间隔距离可增大或减小,以经由所述弹性臂带动各所述主夹臂相对于所述夹持座枢转;当所述锁紧结构维持于所述锁紧状态时,可经由各所述弹性臂向各所述主夹臂施加持续的弹性抵推力,以促使各所述主夹臂相对于所述夹持座朝接近所述辅夹臂的方向枢转,使得形成于所述主夹臂和所述辅夹臂之间的所述夹合角度维持最小化。
- 根据权利要求6所述的夹持器械,其特征在于,当所述锁紧结构处于所述锁紧状态时,所述主夹臂可根据所述目标组织的厚度向所述弹性臂施加反向作用力,以使所述弹性臂产生不同程度的弹性变形,直至所述弹性臂的所述弹性抵推力与所述主夹臂的所述反向作用力达到平衡。
- 根据权利要求7所述的夹持器械,其特征在于,所述弹性臂包括弓形弯折部、S型弯折部、Z型弯折部中的至少一个。
- 根据权利要求6所述的夹持器械,其特征在于,各所述主夹臂可共轴枢接或非共轴枢接至所述夹持座。
- 根据权利要求6所述的夹持器械,其特征在于,所述辅夹臂可在受力状态下弹性变形,以相对于所述夹持座朝远离所述主夹臂的方向枢转,以使形成于所述辅夹臂和所述主夹臂之间的所述夹合角度增大;所述辅夹臂可在非受力状态下弹性恢复,以相对于所述夹持座朝接近所述主夹臂的方向枢转,以使形成于所述辅夹臂和所述主夹臂之间的所述夹合角度变小。
- 根据权利要求10所述的夹持器械,其特征在于,所述辅夹臂包括夹持部和枢接部,所述夹持部可经由所述枢接部枢接所述夹持座;所述枢接部可在受力状态下弹性变形并在非受力状态下弹性恢复,以供所述夹持部相对于所述夹持座枢转。
- 根据权利要求10所述的夹持器械,其特征在于,各所述辅夹臂为一体式结构或分离式结构。
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