CN113456297A - Clamping apparatus - Google Patents
Clamping apparatus Download PDFInfo
- Publication number
- CN113456297A CN113456297A CN202110745543.6A CN202110745543A CN113456297A CN 113456297 A CN113456297 A CN 113456297A CN 202110745543 A CN202110745543 A CN 202110745543A CN 113456297 A CN113456297 A CN 113456297A
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- clamping
- arm
- seat
- mandrel
- auxiliary
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- 210000004115 mitral valve Anatomy 0.000 claims description 9
- 230000005489 elastic deformation Effects 0.000 claims description 8
- 210000000591 tricuspid valve Anatomy 0.000 claims description 8
- 230000003247 decreasing effect Effects 0.000 claims description 6
- 230000000149 penetrating effect Effects 0.000 claims description 2
- 230000015572 biosynthetic process Effects 0.000 claims 2
- 238000005755 formation reaction Methods 0.000 claims 2
- 210000003709 heart valve Anatomy 0.000 description 8
- 210000005246 left atrium Anatomy 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 210000005240 left ventricle Anatomy 0.000 description 4
- 230000008439 repair process Effects 0.000 description 4
- 206010067171 Regurgitation Diseases 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 206010019280 Heart failures Diseases 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 210000001765 aortic valve Anatomy 0.000 description 2
- 238000013459 approach Methods 0.000 description 2
- 230000004087 circulation Effects 0.000 description 2
- 230000035876 healing Effects 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 210000003102 pulmonary valve Anatomy 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000002861 ventricular Effects 0.000 description 2
- 206010013012 Dilatation ventricular Diseases 0.000 description 1
- 206010067660 Heart valve incompetence Diseases 0.000 description 1
- 206010020880 Hypertrophy Diseases 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 206010064911 Pulmonary arterial hypertension Diseases 0.000 description 1
- 206010037368 Pulmonary congestion Diseases 0.000 description 1
- 206010067282 Right atrial dilatation Diseases 0.000 description 1
- 206010039163 Right ventricular failure Diseases 0.000 description 1
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 1
- 230000001746 atrial effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 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
- 208000005907 mitral valve insufficiency Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 238000010992 reflux Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
Images
Classifications
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- 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
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- 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)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The application provides a clamping apparatus, mainly includes the base, the circumference distributes two at least clamping structure on the base to and correspond and set up in two at least butt structures of one side of the adjacent base of each clamping structure, wherein, when each clamping structure is in the locking condition, each butt structure of pressing from both sides between base and each clamping structure can apply the thrust to each clamping structure respectively, in order to adjust each clamping clearance that each clamping structure corresponds. Therefore, the clamping device can provide stable and continuous clamping force.
Description
Technical Field
The embodiment of the application relates to the technical field of medical instruments, in particular to a clamping instrument.
Background
Mitral valve, tricuspid valve, aortic valve, pulmonary valve, etc. commonly occur as valvular insufficiency, and in the case of mitral valve, during systole, a portion of the blood in the left ventricle flows back through the orifice of the incompetent mitral valve to the left atrium. The left atrium receives blood from both left ventricular regurgitation and pulmonary venous inflow, and the volume of left atrial blood increases dramatically, raising pressure, and leading to hypertrophy of the left atrium.
In diastole, more blood flows from the left atrium to the left ventricle, so that the left ventricle is enlarged due to the enhanced contraction, after the compensation phase is progressed to the decompensation phase, both the left atrium and the left ventricle are subjected to heart failure, and further pulmonary congestion, pulmonary arterial hypertension, right ventricular enlargement, right atrial enlargement, right heart failure and body circulation congestion sequentially occur.
Traditional treatment means include active surgical approaches or palliative efforts to combat inevitable heart failure with drugs. Among the surgical methods are valve replacement and annuloplasty. In surgical procedures, typical open chest surgery is invasive, requires the establishment of extracorporeal circulation, has a high complication rate and risk of infection, and results in many patients not tolerating the enormous surgical risk and simply waiting for death.
At present, fewer products for treating mitral valve regurgitation and tricuspid valve regurgitation through minimally invasive catheters are approved in China, and the products need to change the structure of the heart in the healing process, thereby bringing great pressure and inadaptability to the heart after operation.
Thus, there is a need for a product that does not require changes to the heart structure while treating valve regurgitation through minimally invasive pathways.
Disclosure of Invention
In view of the above, the present application provides a clamping device to overcome or at least partially address the above-mentioned problems.
The embodiment of the application provides a clamping apparatus, which comprises a base; the clamping structures are circumferentially distributed on the base and used for clamping target tissues, and each clamping structure is provided with an adjustable clamping gap in a locking state; the at least two abutting structures are correspondingly arranged on one side of each clamping structure, which is adjacent to the base; when each clamping structure is in the locked state, each abutting structure clamped between the base and each clamping structure can apply abutting force to each clamping structure respectively so as to adjust each clamping gap corresponding to each clamping structure.
Optionally, the clamping apparatus includes two clamping structures respectively disposed on opposite sides of the base for clamping an anterior mitral valve and a posterior mitral valve, respectively.
Optionally, the clamping device comprises two clamping structures arranged on the base in a surrounding manner, and the two clamping structures are used for respectively clamping any two valves of the tricuspid valve; or the clamping device comprises three clamping structures which are arranged on the base in a surrounding way and are used for clamping each valve of the tricuspid valve respectively.
Optionally, the base comprises: a mandrel; the clamping seat is movably arranged on the mandrel in a penetrating way; the adjusting seat is fixedly connected with the mandrel; the adjusting seat can be forced to move relative to the clamping seat, so that the spacing distance between the adjusting seat and the clamping seat is increased or decreased.
Optionally, the clamping apparatus further comprises a clamping structure respectively disposed on the clamping seat and the adjusting seat, and the clamping structure can be switched between a clamping state and a non-clamping state; when the clamping structure is in the clamping state, the spacing distance between the adjusting seat and the clamping seat can be locked, so that each clamping structure is in the locking state; when the clamping structure is in the non-clamping state, the spacing distance between the adjusting seat and the clamping seat can be adjusted, so that each clamping structure is in a non-locking state.
Optionally, the clamping structure includes at least one first clamping portion arranged around the clamping seat and at least one second clamping portion arranged around the adjusting seat; each first clamping part can be clamped with each second clamping part respectively; one of the first clamping portion and the second clamping portion comprises a clamping hook, the other of the first clamping portion and the second clamping portion comprises at least one clamping groove distributed along the axial direction of the mandrel, and the clamping hook can be mutually clamped with one of the clamping grooves to adjust the spacing distance between the clamping seat and the adjusting seat in the clamping state.
Optionally, the engaging structure further includes at least one elastic arm surrounding the adjusting seat, wherein each of the second engaging portions is disposed at each end portion corresponding to each of the elastic arms.
Optionally, the engaging structure further includes unlocking portions disposed on the elastic arms, and the mandrel further includes an inner tube and an outer tube sleeved with each other; wherein the outer tube is movable relative to the inner tube between an abutting position and a non-abutting position; when the outer pipe is in the abutting position, the unlocking part abuts against the outer pipe, the elastic arm generates elastic deformation by the abutting of the outer pipe and expands radially outwards, so that the second clamping part and the first clamping part are mutually separated, and the clamping structure is in the non-clamping state; when the outer tube is in the non-abutting position, the elastic arm elastically recovers in a non-stressed state and radially retracts inwards, so that the second clamping portion and the first clamping portion are clamped with each other, and the clamping structure is in the clamping state.
Optionally, each of the clamping structures comprises: the main clamping arm is pivoted with the clamping seat; an auxiliary clamping arm connected with the mandrel or the clamping seat and positioned between the main clamping arm and the mandrel, wherein the auxiliary clamping arm can generate elastic deformation and pivot relative to the mandrel or the clamping seat; the pivoting arms are respectively pivoted with the main clamping arm and the adjusting seat; when the spacing distance between the adjusting seat and the clamping seat is gradually reduced, the main clamping arm can be driven to pivot relative to the clamping seat through the pivoting arm in a direction approaching to the auxiliary clamping arm, and each auxiliary clamping arm can generate elastic deformation under the pushing force of the main clamping arm and pivot relative to the mandrel or the clamping seat in a linkage manner, so that the pivoting angle between the clamping structure and the mandrel is gradually reduced; when the spacing distance between the adjusting seat and the clamping seat is gradually increased, the main clamping arm can be driven to pivot relative to the clamping seat in the direction away from the auxiliary clamping arm through the pivoting arm, and meanwhile, the auxiliary clamping arm can elastically recover to pivot relative to the mandrel or the clamping seat in the direction close to the main clamping arm, so that the pivoting angle between the clamping structure and the mandrel is gradually increased.
Optionally, each of the auxiliary clamping arms of each of the clamping structures may be integrally formed.
Optionally, each of the clamping structures further comprises a traction member connected to the auxiliary clamping arm for driving the auxiliary clamping arm to elastically deform and pivot relative to the mandrel or the clamping seat, so that the pivot angle between the auxiliary clamping arm and the mandrel is reduced.
Optionally, the abutting structure is arranged on one side of the auxiliary clamping arm, which is far away from the main clamping arm; when the clamping structure is in the locking state, the pivoting angle between the main clamping arm and the mandrel is fixed, and the abutting structure generates elastic deformation between the auxiliary clamping arm and the mandrel to form different abutting intervals so as to adjust the pivoting angle between the auxiliary clamping arm and the mandrel, so that the clamping gap of the clamping structure in the locking state is adjusted.
Optionally, the abutting structure comprises an arched dome, and an arching height of the arched dome is greater than 0.2 mm.
Optionally, the arched elastic piece comprises two fixing ends, and the two fixing ends are respectively and fixedly arranged on the auxiliary clamping arm.
Optionally, two opposite sides of the arched elastic sheet include a fixed end and a free end, the fixed end is fixedly arranged on the auxiliary clamping arm, and the free end is slidably arranged on the auxiliary clamping arm; or the arched elastic sheet comprises two free ends which are respectively arranged on the auxiliary clamping arms in a sliding way.
Optionally, the secondary clip arm comprises at least one runner for providing that the free end is slidably disposed therein.
To sum up, but the pivot of the auxiliary clamping arm of independent control of the clamping apparatus that this application embodiment provided actuates with the pivot of main clamping arm for target tissue can be caught to the clamping structure accessible multiple mode, thereby improve target tissue's the success rate of catching, is particularly useful for treating heart valve regurgitation.
In addition, the clamping gap of the clamping structure in the locking state is adjusted by the abutting structure, and stable clamping force can be provided.
In addition, the multistage clamping structure is arranged, so that the clamping force of the clamping structure in the locking state can be adjusted to be suitable for clamping target tissues with different thicknesses. In addition, the design of the unlocking part can be used for repeatedly switching the clamping structure between the locking state and the non-locking state so as to adjust the clamping operation, thereby achieving a better clamping effect.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments described in the embodiments of the present application, and other drawings can be obtained by those skilled in the art according to the drawings.
Fig. 1 shows a schematic view of the overall structure of the clamping instrument of the present application.
Fig. 2 is a schematic sectional view taken along line a-a of fig. 1.
Figure 3 shows an exploded view of the clamping instrument of the present application.
Fig. 4-6 show partial schematic views of the snap-fit structure of the clip-on instrument of the present application.
Fig. 7 shows a partial schematic view of the abutment structure of the clamping instrument of the present application.
Fig. 8-9 are schematic views of the clamping device and the delivery system of the present application.
Fig. 10-17 are schematic illustrations of different operational stages of performing a heart valve repair treatment using the clamping apparatus of the present application.
Element number
10: a clamping device;
20: a base;
202: a mandrel;
2021: an inner tube;
2022: an outer tube;
204: a clamping seat;
206: an adjusting seat; a
30: a clamping structure;
302: a main clamping arm;
304: auxiliary clamping arms;
305: a chute;
306: a pivoting arm;
308: a traction member;
310/312: a pivotal shaft;
40: an abutting structure;
402: an arched shrapnel;
404: a fixed end;
406: a free end;
50: a snap-fit structure;
502: a first engaging portion;
504: a second engaging portion;
506: a hook;
508: a card slot;
510: a resilient arm;
512: an unlocking portion;
60: a delivery system;
70: a target tissue.
Detailed Description
In order to make those skilled in the art better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, but not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application shall fall within the scope of the protection of the embodiments in the present application.
The following further describes specific implementations of the embodiments of the present application with reference to the drawings of the embodiments of the present application.
The clamping apparatus 10 of the present embodiment can be used as a margin-to-margin repair implant in the field of interventional treatment of structural heart diseases, and can achieve repair treatment of heart valve leaflets (such as mitral valve, tricuspid valve, aortic valve, pulmonary valve, etc.) by a transvascular minimally invasive approach or by auricle access to a designated anatomical location.
As shown in fig. 1-3, the clamping instrument 10 of the present application generally includes a base 20, at least two clamping structures 30, and at least two abutment structures 40.
Optionally, the base 20 may include a mandrel 202, a holder 204 movably disposed on the mandrel 202, and an adjustment seat 206 fixedly coupled to the mandrel 202.
Wherein, the adjusting seat 206 can be forced to move relative to the clamping seat 204, so that the spacing distance between the adjusting seat 206 and the clamping seat 204 is increased or decreased.
In the present embodiment, each clamping structure 30 is circumferentially distributed on the base 20, and each clamping structure 30 is used for clamping the target tissue and has an adjustable clamping gap in the locked state.
Alternatively, the clamping device 10 may include two clamping structures 30 disposed on opposite sides of the base 20 for clamping the anterior and posterior mitral valves, respectively.
Alternatively, the clamping device 10 may include two clamping structures 30 disposed around the base 20 for respectively clamping any two pieces of the tricuspid valve.
Optionally, the clamping device 10 may include three clamping structures 30 surrounding the base 20 for clamping respective ones of the tricuspid valves.
In the present embodiment, each of the clamping structures 30 can be switched between a locking state and a non-locking state, each of the clamping structures 30 can respectively clamp different valve leaflets, and when in the locking state, each of the clamping structures 30 is respectively drawn toward the base 20, so that the backflow gap between the valve leaflets clamped in each of the clamping structures 30 is reduced, thereby achieving the purpose of reducing the backflow.
Optionally, each of the gripping structures 30 includes a primary clip arm 302, a secondary clip arm 304, and a pivot arm 306.
In the present embodiment, the main clamping arm 302 is pivotally connected to the clamping base 204.
In the present embodiment, the auxiliary clamping arm 304 can be connected to the core shaft 202 (as shown in the figures of the present application), but not limited thereto, and the auxiliary clamping arm 304 can also be connected to the clamping seat 204.
In this embodiment, the auxiliary clamp arm 304 is disposed between the main clamp arm 302 and the mandrel 202 and is elastically deformable to pivot relative to the mandrel 202 or the clamp base 204.
Alternatively, each of the auxiliary clip arms 304 of each of the clip structures 30 may be an integrally formed structure, or a split structure.
Optionally, each of the clamping structures 30 further includes a pulling member 308 (see fig. 9) connected to the auxiliary clamp arm 304 for driving the auxiliary clamp arm 304 to elastically deform to pivot relative to the mandrel 202 or the clamp base 204, so that the pivot angle between the auxiliary clamp arm 304 and the mandrel 202 is reduced.
It should be noted that the reference to the pivot angle of main clamp arm 302/auxiliary clamp arm 304 relative to mandrel 202 in this application refers to the angle formed between the extension of main clamp arm 302/auxiliary clamp arm 304 and the axis of mandrel 202, and the same is used hereinafter.
In this embodiment, the pivot arm 306 pivotally connects the main clamp arm 302 and the adjustment base 206, respectively.
Specifically, opposite ends of the pivot arm 306 may be pivotally connected to the main clamp arm 302 and the adjustment seat 206 via pivot shafts 310 and 312, respectively (see fig. 3).
In the present embodiment, when the adjusting seat 206 is driven to move relative to the clamping seat 204, so that the distance between the adjusting seat 206 and the clamping seat 204 is gradually decreased, the main arm 302 can be driven to pivot relative to the clamping seat 204 via the pivot arm 306 toward the direction of approaching the auxiliary arm 304, in this state, each auxiliary arm 304 can be elastically deformed by the pushing force of the main arm 302 to pivot relative to the mandrel 202 or the clamping seat 204 in an interlocking manner, so that the pivot angle between the clamping structure 30 and the mandrel 202 is gradually decreased (i.e., the pivot angle of the main arm 302 and the auxiliary arm 304 relative to the mandrel 202 is decreased).
Conversely, when the spacing distance between the adjustment seat 206 and the clamp seat 204 gradually increases, the main clamp arm 302 can be driven to pivot relative to the clamp seat 204 in a direction away from the auxiliary clamp arm 304 via the pivot arm 306, and in this state, since the pushing force of the main clamp arm 302 against the auxiliary clamp arm 304 is released, the auxiliary clamp arm 304 elastically recovers and pivots relative to the core shaft 202 or the clamp seat 204 in a direction approaching the main clamp arm 302, so that the pivot angle between the clamp structure 30 and the core shaft 202 gradually increases (i.e., the pivot angles of the main clamp arm 302 and the auxiliary clamp arm 304 relative to the core shaft 202 both increase).
Referring to fig. 4 to fig. 6, the clamping apparatus 10 further includes a clamping structure 50 disposed on the clamping seat 204 and the adjusting seat 206, and the clamping structure can be switched between a clamping state and a non-clamping state.
Specifically, when the clamping structure 50 is in the clamping state, the spacing distance between the adjusting seat 206 and the clamping seat 204 can be locked, so that each clamping structure 30 is in the locking state; when the engaging structure 50 is in the non-engaging state, the distance between the adjusting seat 206 and the clamping seat 204 can be adjusted to make each clamping structure 30 in the non-locking state.
In this embodiment, when the engaging structure 50 is in the engaging state, i.e. when the clamping structure 30 is in the locking state, the pivoting angle of the main clamping arm 302 relative to the core shaft 202 is locked, and when the engaging structure 50 is in the non-engaging state, i.e. when the clamping structure 30 is in the non-locking state, the main clamping arm 302 can pivot relative to the core shaft 202.
Alternatively, the engaging structure 50 may include at least one first engaging portion 502 surrounding the holder 204 and at least one second engaging portion 504 surrounding the adjusting seat 206, and each first engaging portion 502 may be engaged with each second engaging portion 504.
As shown in fig. 4 to 6, in the present embodiment, the engaging structure 50 includes two first engaging portions 502 disposed on two opposite sides of the clamping seat 204 and two second engaging portions 504 disposed on two opposite sides of the adjusting seat 206.
In the present embodiment, one of the first engaging portion 502 and the second engaging portion 504 may include a hook 506, and the other of the first engaging portion 502 and the second engaging portion 504 may include at least one engaging groove 508 distributed along the axial direction of the core shaft 202, wherein the hook 506 may engage with one of the engaging grooves 508 to adjust a distance between the clamping seat 204 and the adjusting seat 206 in the engaging state, that is, to adjust a pivoting angle of the main clamping arm 302 in the locking state relative to the core shaft 202, and by means of the multi-stage engaging structure design, the clamping device 10 of the present application may be adapted to clamp target tissues (e.g., valves) with different thicknesses.
Optionally, the engaging structure 50 further includes at least one elastic arm 510 surrounding the adjusting base 206 (the number of the elastic arms 510 corresponds to the number of the clamping structures 30), wherein each second engaging portion 504 is disposed at each end of each elastic arm 510.
Optionally, the engaging structure 50 further includes unlocking portions 512 disposed on the elastic arms 510, and the core shaft 202 further includes an inner tube 2021 and an outer tube 2022 sleeved with each other.
In the present embodiment, the outer tube 2022 is movable between an abutting position and a non-abutting position with respect to the axial direction of the inner tube 2021.
Specifically, when the outer tube 2022 is at the abutting position, the unlocking portion 512 can abut against the outer tube 2022, and in this state, the elastic arm 510 is elastically deformed by the abutting force of the outer tube 2022 and expands radially outward, so that the second engaging portion 504 and the first engaging portion 502 are disengaged from each other, and the engaging structure 50 is in a non-engaging state (refer to the state shown in fig. 4 and 5).
When the outer tube 2022 is at the non-abutting position, the elastic arms 510 can elastically recover to be radially retracted under the non-stressed state, so that the second engaging portion 504 and the first engaging portion 502 are engaged with each other, and the engaging structure 50 is in the engaging state (refer to the state shown in fig. 6).
Therefore, the outer tube 2022 is reciprocated between the abutting position and the non-abutting position relative to the inner tube 2021, so that the clamping operation of the clamping structure 30 on the target tissue can be adjusted for multiple times, thereby improving the clamping effect.
In the present embodiment, each abutting structure 40 is correspondingly disposed on a side of each clamping structure 30 adjacent to the base 20.
Alternatively, when each clamping structure 30 is in the locked state, each abutting structure 40 sandwiched between the base 20 and each clamping structure 30 can respectively abut against each clamping structure 30 to generate a deformation in each clamping gap corresponding to each clamping structure 30.
Alternatively, the abutment structure 40 may be provided on a side of the auxiliary clamp arm 304 facing away from the main clamp arm 302 (refer to fig. 7).
When the clamping structure 30 is in the locked state, the pivot angle between the main clamping arm 302 and the core shaft 202 is fixed, and the abutting structure 40 can be elastically deformed between the auxiliary clamping arm 304 and the core shaft 202 to form different abutting intervals, so as to adjust the pivot angle between the auxiliary clamping arm 304 and the core shaft 202 until the abutting force applied by the abutting structure 40 to the auxiliary clamping arm 304 and the abutting force applied by the main clamping arm 302 to the auxiliary clamping arm 304 via the target tissue reach a balance, thereby adjusting the clamping gap (i.e., the interval distance between the main clamping arm 302 and the auxiliary clamping arm 304) of the clamping structure 30 in the locked state. By means of the design mechanism, the clamping structure 30 can maintain stable clamping force, thereby improving the clamping effect of the target tissue.
Optionally, the abutting structure 40 may include an arched dome 402, wherein the arched height of the arched dome 402 may be greater than 0.2mm, and preferably, may be between 0.2mm and 2 mm.
Alternatively, the arched elastic piece 402 may include two fixing ends 404, and are respectively fixed on the auxiliary clip arms 304.
Alternatively, the opposite sides of the dome-shaped spring 402 may include a fixed end 404 and a free end 406, wherein the fixed end 404 may be fixed to the auxiliary clip arm 304, and the free end 406 may be slidably disposed on the auxiliary clip arm 304.
Alternatively, the dome shaped dome 402 may include two free ends 406, each slidably disposed on the secondary clip arm 304.
Optionally, the secondary clip arm 304 may include at least one sliding slot 305 for positioning a free end 406 of the arcuate spring 402 for sliding the free end 406 along the sliding slot 305 relative to the secondary clip arm 304.
In this embodiment, the clamping device 10 can be used with a delivery system 60 to perform a clamping operation of the clamping device 10 against a target tissue (e.g., a valve) (see fig. 8 and 9).
A method of using the clamping device 10 of the present application to perform a heart valve repair procedure will now be described with reference to fig. 10-17.
The clamping instrument 10 is delivered by a delivery system 60 to the vicinity of a target tissue 70 (e.g., a heart valve) to be repaired (see fig. 10).
The adjustment base 206 of the clamping apparatus 10 is controlled by the delivery system 60 to move in a distal direction relative to the clamping base 204, so that the separation distance between the adjustment base 206 and the clamping base 204 is increased, and the main clamping arm 302 is driven to pivot relative to the clamping base 204 via the pivoting arm 306 to open, i.e., the pivoting angle between the main clamping arm 302 and the mandrel 202 is increased, in this state, the auxiliary clamping arm 304 can be pivoted relative to the mandrel 202 to open synchronously under the action of the elastic restoring force (refer to fig. 11).
A pulling force is applied to auxiliary clamp arm 304 by, for example, a pulling member 308 connected to auxiliary clamp arm 304 to elastically deform auxiliary clamp arm 304 to pivot relative to core shaft 202 and to abut opposite sides of core shaft 202 such that the angle of engagement between main clamp arm 302 and auxiliary clamp arm 304 is maintained sufficiently large to provide for positioning of target tissue 70 (e.g., a heart valve) to be repaired between main clamp arm 302 and auxiliary clamp arm 304 (see fig. 12 and 13).
Target tissue 70 (e.g., a heart valve) is clamped between main clamp arm 302 and auxiliary clamp arm 304 by releasing pull member 308 to pivot auxiliary clamp arm 304 relative to mandrel 202 in a direction approaching main clamp arm 302 under the action of elastic restoring force (see fig. 14 and 15). It should be noted that since each of the auxiliary clip arms 304 is independently pivotable relative to the mandrel 202, the clipping operation of different clipping structures 30 for different valves can be independently performed, thereby reducing the difficulty of capturing the valves.
In this operation, if the clamping position of the target tissue 70 is not ideal, the auxiliary clamp arm 304 can be pulled again by the pulling member 308 to release the target tissue 70 clamped between the auxiliary clamp arm 304 and the main clamp arm 302, and the target tissue 70 can be captured again until the clamping state of the target tissue 70 meets the expectation.
The adjusting base 206 of the clamping apparatus 10 is controlled by the conveying system 60 to move in a proximal direction relative to the clamping base 204, so that the distance between the adjusting base 206 and the clamping base 204 is reduced, the main clamping arm 302 is driven to pivot in a reverse direction relative to the clamping base 204 through the pivoting arm 306, so that the pivoting angle between the main clamping arm 302 and the core shaft 202 is gradually reduced, the auxiliary clamping arm 304 is driven to gradually close toward the core shaft 202, and the clamping structure 50 is switched from a non-clamping state to a clamping state to lock the distance between the adjusting base 206 and the clamping base 204, so that each clamping structure 30 is in a locking state (refer to fig. 16).
In this state, each abutting structure 40 interposed between each auxiliary clamping arm 304 and the mandrel 202 can apply an abutting force to each clamping structure 30, so that each clamping gap corresponding to each clamping structure 30 is deformed, thereby applying a stable clamping force to the target tissue clamped therebetween.
Specifically, abutment structure 40 is capable of elastically deforming to different extents between secondary clamp arm 304 and mandrel 202 to apply different levels of force to secondary clamp arm 304, while primary clamp arm 302 also applies a counter force to secondary clamp arm 304 via target tissue 70, thereby finely adjusting the pivot angle of secondary clamp arm 304 relative to mandrel 202 until an equilibrium is reached therebetween, thereby ensuring that target tissue 70 is stably and firmly clamped between primary clamp arm 302 and secondary clamp arm 304.
The delivery system 60 and the clamping device 10 are detached from each other to withdraw the delivery system 60, leaving only the clamping device 10 in the patient, thereby completing the clamping operation of the target tissue 70 (e.g., a heart valve).
In summary, the clamping apparatus provided herein can be used to adjust the gap of the leaflet coaptation surface, thereby reducing regurgitation.
Moreover, the clamping gap of the clamping structure in the locking state can be adjusted through the design of the abutting structure, so that stable and continuous clamping force can be provided for target tissues, and the volume of the valve leaflet in coaptation can be effectively increased by means of the design mechanism, so that the backflow surface of the clamping position can be reduced.
In addition, the pivot angle of the main clamping arm relative to the mandrel in the locking state can be adjusted by means of the multi-stage clamping structure design, so that the clamping device is suitable for clamping target tissues with different thicknesses. And the clamping structure can be repeatedly switched between the clamping state and the non-clamping state, so that the clamping operation aiming at the target tissue can be adjusted for many times until the clamping effect meets the expectation, the operation of a doctor can be facilitated, and the success rate of the operation can be effectively improved.
In addition, because each clamping structure can independently perform the capture operation of the heart valve leaflet, the valve leaflet edge can be more easily adjusted and captured, the difficulty of capturing the valve leaflet is greatly reduced,
in addition, the clamping apparatus of the application can not bring the problem of stenosis to the operator, and can not influence the problem of left ventricular outflow tract of the operator after the reflux healing, thereby having the advantages of safe and reliable use.
Finally, it should be noted that: the above embodiments are only used for illustrating the technical solutions of the embodiments of the present application, and are not limited thereto; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions in the embodiments of the present application.
Claims (16)
1. A clamping instrument, comprising:
a base;
the clamping structures are circumferentially distributed on the base and used for clamping target tissues, and each clamping structure is provided with an adjustable clamping gap in a locking state; and
at least two abutting structures which are correspondingly arranged on one side of each clamping structure adjacent to the base;
when each clamping structure is in the locked state, each abutting structure clamped between the base and each clamping structure can apply abutting force to each clamping structure respectively so as to adjust each clamping gap corresponding to each clamping structure.
2. The clamping instrument of claim 1, wherein the clamping instrument comprises two clamping structures disposed on opposite sides of the base for clamping an anterior mitral valve and a posterior mitral valve, respectively.
3. The clamping instrument of claim 1,
the clamping device comprises two clamping structures which are arranged on the base in a surrounding way and are used for respectively clamping any two valves of the tricuspid valve; or
The clamping device comprises three clamping structures which are arranged on the base in a surrounding mode and are used for clamping each valve of the tricuspid valve respectively.
4. The clamping instrument of claim 1, wherein the base comprises:
a mandrel;
the clamping seat is movably arranged on the mandrel in a penetrating way;
the adjusting seat is fixedly connected with the mandrel;
the adjusting seat can be forced to move relative to the clamping seat, so that the spacing distance between the adjusting seat and the clamping seat is increased or decreased.
5. The clamping apparatus according to claim 4, further comprising a clamping structure disposed on the clamping seat and the adjusting seat, and switchable between a clamping state and a non-clamping state;
when the clamping structure is in the clamping state, the spacing distance between the adjusting seat and the clamping seat can be locked, so that each clamping structure is in the locking state; when the clamping structure is in the non-clamping state, the spacing distance between the adjusting seat and the clamping seat can be adjusted, so that each clamping structure is in a non-locking state.
6. The clamping instrument of claim 5, wherein the clamping structure comprises at least one first clamping portion surrounding the clamping seat and at least one second clamping portion surrounding the adjustment seat;
each first clamping part can be clamped with each second clamping part respectively;
one of the first clamping portion and the second clamping portion comprises a clamping hook, the other of the first clamping portion and the second clamping portion comprises at least one clamping groove distributed along the axial direction of the mandrel, and the clamping hook can be mutually clamped with one of the clamping grooves to adjust the spacing distance between the clamping seat and the adjusting seat in the clamping state.
7. The clamping instrument of claim 5, wherein the clamping structure further comprises at least one resilient arm disposed about the adjustment block, wherein each of the second clamping portions is disposed at a respective end of each of the resilient arms.
8. The clamping instrument of claim 7, wherein the engaging structure further comprises unlocking portions provided on the elastic arms, and the mandrel further comprises an inner tube and an outer tube that are sleeved with each other; wherein,
the outer tube is movable between an abutting position and a non-abutting position with respect to an axial direction of the inner tube;
when the outer pipe is in the abutting position, the unlocking part abuts against the outer pipe, the elastic arm generates elastic deformation by the abutting of the outer pipe and expands radially outwards, so that the second clamping part and the first clamping part are mutually separated, and the clamping structure is in the non-clamping state;
when the outer tube is in the non-abutting position, the elastic arm elastically recovers in a non-stressed state and radially retracts inwards, so that the second clamping portion and the first clamping portion are clamped with each other, and the clamping structure is in the clamping state.
9. The clamping instrument of claim 4, wherein each of the clamping structures each comprises:
the main clamping arm is pivoted with the clamping seat;
an auxiliary clamping arm connected with the mandrel or the clamping seat and positioned between the main clamping arm and the mandrel, wherein the auxiliary clamping arm can generate elastic deformation and pivot relative to the mandrel or the clamping seat; and
the pivoting arms are respectively pivoted with the main clamping arm and the adjusting seat; wherein,
when the spacing distance between the adjusting seat and the clamping seat is gradually reduced, the main clamping arm can be driven to pivot relative to the clamping seat towards the direction approaching to the auxiliary clamping arm through the pivoting arm, and each auxiliary clamping arm can generate elastic deformation by the pushing force of the main clamping arm and can pivot relative to the mandrel or the clamping seat in a linkage manner, so that the pivoting angle between the clamping structure and the mandrel is gradually reduced;
when the spacing distance between the adjusting seat and the clamping seat is gradually increased, the main clamping arm can be driven to pivot relative to the clamping seat in the direction away from the auxiliary clamping arm through the pivoting arm, and meanwhile, the auxiliary clamping arm can elastically recover to pivot relative to the mandrel or the clamping seat in the direction close to the main clamping arm, so that the pivoting angle between the clamping structure and the mandrel is gradually increased.
10. A clamping apparatus according to claim 9, wherein each of said secondary clamping arms of each of said clamping formations is integrally formed.
11. A clamping apparatus according to claim 9, wherein each clamping structure further comprises a traction member connected to said secondary clamp arm for driving said secondary clamp arm to elastically deform to pivot relative to said mandrel or said holder such that the pivot angle between said secondary clamp arm and said mandrel is reduced.
12. A clamping apparatus according to claim 9, wherein the abutment formation is provided on a side of the secondary clamp arm facing away from the primary clamp arm;
when the clamping structure is in the locking state, the pivoting angle between the main clamping arm and the mandrel is fixed, and the abutting structure generates elastic deformation between the auxiliary clamping arm and the mandrel to form different abutting intervals so as to adjust the pivoting angle between the auxiliary clamping arm and the mandrel, so that the clamping gap of the clamping structure in the locking state is adjusted.
13. A clamping instrument according to claim 12, wherein the abutment structure comprises an arched spring having an arching height of greater than 0.2 mm.
14. A clamping apparatus according to claim 13, wherein said arcuate resilient member includes two fixed ends which are respectively secured to said secondary clamp arms.
15. A clamping instrument according to claim 12,
the two opposite sides of the arched elastic sheet comprise a fixed end and a free end, the fixed end is fixedly arranged on the auxiliary clamping arm, and the free end is slidably arranged on the auxiliary clamping arm; or
The arched elastic sheet comprises two free ends which are respectively arranged on the auxiliary clamping arms in a sliding way.
16. A clamping instrument according to claim 15, wherein said secondary clamp arm includes at least one runner for providing said free end slidably disposed therein.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110745543.6A CN113456297A (en) | 2021-06-30 | 2021-06-30 | Clamping apparatus |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110745543.6A CN113456297A (en) | 2021-06-30 | 2021-06-30 | Clamping apparatus |
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| Publication Number | Publication Date |
|---|---|
| CN113456297A true CN113456297A (en) | 2021-10-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110745543.6A Pending CN113456297A (en) | 2021-06-30 | 2021-06-30 | Clamping apparatus |
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| CN (1) | CN113456297A (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113616387A (en) * | 2021-10-11 | 2021-11-09 | 上海汇禾医疗器械有限公司 | Valve clamping device and valve repair system |
| CN113749822A (en) * | 2021-09-16 | 2021-12-07 | 上海汇禾医疗器械有限公司 | Implantable medical device |
| WO2022237037A1 (en) * | 2021-05-11 | 2022-11-17 | 上海汇禾医疗科技有限公司 | Clamping instrument |
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| WO2021008461A1 (en) * | 2019-07-12 | 2021-01-21 | 杭州德晋医疗科技有限公司 | Easily operable valve clamping device and valve clamping system |
| CN112741709A (en) * | 2019-10-30 | 2021-05-04 | 杭州德晋医疗科技有限公司 | Adjustable valve clamping system |
| CN216060882U (en) * | 2021-06-30 | 2022-03-18 | 上海汇禾医疗器械有限公司 | Clamping apparatus |
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| WO2021008461A1 (en) * | 2019-07-12 | 2021-01-21 | 杭州德晋医疗科技有限公司 | Easily operable valve clamping device and valve clamping system |
| CN112741709A (en) * | 2019-10-30 | 2021-05-04 | 杭州德晋医疗科技有限公司 | Adjustable valve clamping system |
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| WO2022237037A1 (en) * | 2021-05-11 | 2022-11-17 | 上海汇禾医疗科技有限公司 | Clamping instrument |
| CN113749822A (en) * | 2021-09-16 | 2021-12-07 | 上海汇禾医疗器械有限公司 | Implantable medical device |
| CN113749822B (en) * | 2021-09-16 | 2022-11-22 | 上海汇禾医疗器械有限公司 | Implantable medical device |
| CN113616387A (en) * | 2021-10-11 | 2021-11-09 | 上海汇禾医疗器械有限公司 | Valve clamping device and valve repair system |
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