CN113017924A - Mitral valve clamping system with expansion arm and mitral valve clamping method - Google Patents

Mitral valve clamping system with expansion arm and mitral valve clamping method Download PDF

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Publication number
CN113017924A
CN113017924A CN202110251655.6A CN202110251655A CN113017924A CN 113017924 A CN113017924 A CN 113017924A CN 202110251655 A CN202110251655 A CN 202110251655A CN 113017924 A CN113017924 A CN 113017924A
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China
Prior art keywords
clamping
arm
clamping arm
expansion
mitral valve
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CN202110251655.6A
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Chinese (zh)
Inventor
戴宇峰
潘炳跃
陈健
李涛
王智杰
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Shanghai Hanyu Medical Technology Co ltd
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Shanghai Hanyu Medical Technology Co ltd
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Priority to CN202110251655.6A priority Critical patent/CN113017924A/en
Publication of CN113017924A publication Critical patent/CN113017924A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2451Inserts in the coronary sinus for correcting the valve shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor

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  • 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 invention discloses a mitral valve clamping system with an expansion arm and a mitral valve clamping method, comprising a first clamping mechanism, wherein the first clamping mechanism is provided with at least two first clamping arms; the second clamping mechanism is provided with a plurality of second clamping arms which correspond to the first clamping arms one by one; the connecting mechanism is used for connecting the first clamping mechanism and the second clamping mechanism; the expansion arm is arranged on the side surface of the second clamping arm, extends outwards and is wrapped towards the middle part; wherein, first clamping arm and second clamping arm cooperation form valve clamping device, and the expansion arm is used for clamping valve in order to increase the clamping scope on valve clamping device both sides valve. According to the invention, when the valve clamping device formed by matching the first clamping arm and the second clamping arm clamps the mitral valve, the expansion arms on the side surfaces of the second clamping arms wrap the valve on the side surfaces of the clamping area towards the middle part, so that the clamping range is effectively improved, and the problem of backflow leakage at two sides of the clamp is avoided.

Description

Mitral valve clamping system with expansion arm and mitral valve clamping method
Technical Field
The invention relates to the technical field of medical instruments, in particular to a mitral valve clamping system with an expansion arm and a mitral valve clamping method.
Background
As the population ages, the incidence of valvular heart disease is increasing, with a concomitant trend toward increased incidence of mitral regurgitation. The mitral valve, the left atrioventricular valve, is also known as the mitral valve, and is attached to the left fibrous atrioventricular ring. The function of the mitral valve depends on its own structural integrity. The normal mitral valve consists of an annulus, valve leaflets, chordae tendinae and papillary muscles, the integrity of the function of the mitral valve requires that the annulus of the mitral valve is proper in size, the valve leaflets are complete in structure, the chordae tendineae are pulled by the contraction of the papillary muscles to play a role in supporting the valve leaflets, the closing force generated by the contraction of the muscle of the left ventricle is proper, and the shape and the function of the ventricle are normal. These factors together determine the integrity of the mitral valve, and abnormalities in either factor can lead to mitral regurgitation. According to statistics, in heart valve diseases, mitral valve lesions account for 70% of the valve diseases and account for a large proportion.
My patent CN106175986A discloses a valve connector for heart valve repair by way of catheter-based minimally invasive heart non-stop beating, which is easy to operate and can reduce the strength and difficulty of the surgery for the operator. However, the valve splicer finds the following problems during clinical use: after the mitral valve is clamped by the clamp, the problem of backflow leakage still occurs on two sides of the clamp, so that a good effect can be achieved only by frequently using a plurality of clamps during clinical use, the probability of stenosis of the mitral valve after repair is increased, the operation difficulty is increased, the operation risk is improved, and the medical expense is also increased.
Therefore, there is a strong need for a mitral valve clamping device that increases the range of clamping and avoids regurgitation on either side of the clamp.
Disclosure of Invention
The present invention aims to provide a mitral valve clamping system with an expansion arm to solve the above technical problems.
In order to achieve the purpose, the technical scheme of the invention is as follows:
in a first aspect, the present invention provides a mitral valve clamping system with an expansion arm, comprising:
a first clamping mechanism having at least two first clamping arms;
the second clamping mechanism is provided with a plurality of second clamping arms which correspond to the first clamping arms one by one;
the connecting mechanism is used for connecting the first clamping mechanism and the second clamping mechanism;
the expansion arm is arranged on the side surface of the second clamping arm, extends outwards and is wrapped towards the middle part;
wherein, the first clamping arm and the second clamping arm are matched to form a valve clamping device, and the expansion arm is used for clamping valves on two sides of the valve clamping device so as to increase the clamping range.
Through adopting above-mentioned scheme, when the valve clamping device that first clamping arm and second clamping arm cooperation formed presss from both sides tight mitral valve, the valve of the regional side of clamping is towards middle parcel, has effectively improved the clamping scope with the valve of clamping area side to the expansion arm of second clamping arm side, avoids clip both sides to appear the counter-current problem of revealing.
Furthermore, the expansion arm is a nickel-titanium alloy expansion arm or a shape memory polymer expansion arm, and the expansion arm extends outwards in a natural state and is wrapped towards the middle part.
Through adopting above-mentioned scheme, the expansion arm is the shape memory material, consequently can the deformation shrink, and the sheath pipe of being convenient for is carried, can recover under the shape memory effect and wrap up the clamping to the valve after arriving the position of mediating, effectively reduces sheath pipe bore demand, alleviates the painful and operation degree of difficulty of patient.
Furthermore, the expansion arm is of a C-shaped structure or an O-shaped structure, one side face of the expansion arm is fixed with the side face of the second clamping arm, and the other side face of the expansion arm extends outwards to be wrapped towards the middle.
Furthermore, the expansion arms are symmetrically arranged on two sides of the second clamping arm.
Further, coupling mechanism includes inserted bar and collar, the even symmetry of first clamping arm is installed the inserted bar distal end, the inserted bar near-end inserts the collar hole sets up, the even symmetry of second clamping arm is installed collar distal end surface, and the second clamping arm is established the first clamping arm outside sets up with first clamping arm one-to-one, the inserted bar is followed collar axial slip drives first clamping arm and second clamping arm cooperation form the valve clamping device.
Through adopting above-mentioned scheme, the inserted bar inserts the interior setting of sliding of installing ring axial of installing ring, can drive first clamping arm and second clamping arm and open and shut, is convenient for catch valve.
Furthermore, the first clamping arm and the second clamping arm are both made of shape memory elastic materials, and in a natural state, the first clamping arm and the second clamping arm are opened outwards and extend.
By adopting the scheme, when the clamping system intervenes in the sheath, the first clamping arm and the second clamping arm are staggered in a sliding manner through the insertion rod, and then the first clamping arm and the second clamping arm are compressed, so that the outer diameter of the clamping system can be effectively reduced, the conveying of the sheath is facilitated, the caliber requirement of the sheath is reduced, and the pain of a patient and the operation difficulty of a surgery are reduced; when the clamping system is pushed out of the sheath, the first clamping arm and the second clamping arm are everted and matched to form the valve clamp under the action of shape memory.
Furthermore, the outer side surface of the first clamping arm is uniformly provided with first clamping teeth, the first clamping teeth are obliquely arranged towards the near end, the inner side surface of the second clamping arm is uniformly provided with second clamping teeth, and the second clamping teeth are short blunt teeth.
By adopting the scheme, the first clamping teeth are inclined towards one side of the near end, so that the valve is conveniently fixed by the first clamping teeth when the valve is captured, and the inconvenience in operation caused by slippage or unstable fixation of the valve is prevented; the second clamping teeth are arranged to be short blunt teeth to avoid damaging the valve during clamping.
Further, still include closed ring, closed ring distal end inner wall is equipped with the internal thread, the collar outer wall be equipped with the external screw thread that the internal thread matches, the collar is followed closed ring hole slides and drives first clamping arm and second clamping arm adjust and open the angle.
By adopting the scheme, the closed ring is used for being connected with the conveying pipe to push the clamping system, and the first clamping arm and the second clamping arm can be driven by the closed ring to be folded towards the middle part to control the clamping angle of the valve, so that the clamping capacity and the clamping effect can be improved.
Furthermore, the outer side surface of the second clamping arm is uniformly provided with fixing teeth matched with the internal thread along the extension direction of the second clamping arm, the fixing teeth are matched with the internal thread to clamp the second clamping arm tightly, one side surface of the fixing teeth, which faces the near end, is an obtuse-angle slope, and one side surface, which faces the far end, is an acute-angle slope or a right-angle slope.
By adopting the scheme, the fixed teeth can be matched with the internal threads of the closed ring to limit the clamping system, so that the clamping angle is kept in the body; the obtuse angle slope is convenient for the second clamping arm to slide towards the near end to draw in the first clamping arm and the second clamping arm, and the acute angle slope or the right angle slope is used for clamping the second clamping arm to avoid the installation ring to slide towards the far end, so that the installation ring can be slid according to actual conditions to gradually draw in the first clamping arm and the second clamping arm to adjust the clamping angle.
Further, the surfaces of the first clamping arm, the second clamping arm and the closed ring are coated with biocompatible PET covering films.
In a second aspect, the present invention provides a mitral valve clamping method using the above mitral valve clamping system with an expansion arm, comprising the steps of:
s1, inserting the inserted bar into the mounting ring, screwing the mounting ring into the closed ring, and fixing the mounting ring by matching the internal thread and the external thread;
s2, connecting a push rod with the near end of the inserted rod, connecting a conveying pipe with a closed ring, pushing out the first clamping arm of the push rod to a position staggered with the second clamping arm, compressing the expansion arm, the first clamping arm and the second clamping arm, and completely inserting the clamping system into the sheath to start intervention;
s3, after the intervention is in place, the first clamping arm and the second clamping arm are pushed out of the sheath tube by the aid of the pushing rod and the conveying pipe, and the first clamping arm, the second clamping arm and the expanding arm are expanded under the action of shape memory and adjusted to capture postures;
s4, when the mitral valve is between the first clamping arm and the second clamping arm, the push rod pulls the insertion rod towards the near end to drive the first clamping arm to move towards the near end and the second clamping arm to closely match and clamp the mitral valve;
s5, rotating the closed ring through the conveying pipe, rotating the installation ring into the inner hole of the closed ring, pulling the installation ring towards the near end by using the pushing rod, driving the first clamping arm and the second clamping arm to contract to clamp the mitral valve, wrapping and clamping the mitral valves at two sides towards the middle by the expanding arm, and pushing the closed ring to adjust the contraction clamping angle to control the clamping force;
and S6, after the clamping angle is adjusted, separating the push rod and the insertion rod, separating the conveying pipe and the closed ring, and withdrawing the push rod, the conveying pipe and the sheath pipe to complete the mitral valve clamping.
Compared with the prior art, the invention has the beneficial effects that:
1. according to the invention, the expansion arm is arranged on the side surface of the second clamping arm, and the valve on the side surface of the clamping area is wrapped towards the middle part by the expansion arm, so that the clamping range is effectively improved, and the problem of reverse flow leakage at two sides of the clamp is avoided;
2. the expansion arm, the first clamping arm and the second clamping arm are made of shape memory materials, can deform and contract, are convenient for conveying a sheath, can recover under the action of shape memory after reaching a intervention position to wrap and clamp a valve, effectively reduces the requirement on the caliber of the sheath, and relieves the pain of a patient and the operation difficulty;
3. according to the invention, the first clamping arm and the second clamping arm are connected by adopting the inserting rod and the mounting ring structure, and the first clamping arm and the second clamping arm can be staggered in a sliding way through the inserting rod during conveying, so that the outer diameters of the first clamping arm and the second clamping arm in a compressed state are effectively reduced, the conveying of a sheath tube is facilitated, the requirement on the caliber of the sheath tube is effectively reduced, and the pain of a patient and the operation difficulty are relieved;
4. the closed ring is used for being connected with the pushing rod to push the clamping system, and on the other hand, the closed ring can drive the first clamping arm and the second clamping arm to be folded towards the middle part to control the clamping angle of the valve, so that the clamping capability and the clamping effect can be improved;
5. the outer side surface of the second clamping arm is also uniformly provided with fixed teeth matched with the internal thread, the fixed teeth can be matched with the internal thread of the closed ring to limit the clamping system, so that a clamping angle is kept in the body, an obtuse slope on one side surface of the fixed teeth is convenient for the second clamping arm to slide towards the near end to draw the first clamping arm and the second clamping arm in a folding mode, and an acute slope or a right slope on the other side surface is used for clamping the second clamping arm to avoid the mounting ring from sliding towards the far end, so that the mounting ring can be slid to gradually draw the first clamping arm and the second clamping arm in a folding mode according to actual conditions, and the clamping angle is adjusted;
6. the push rod controls the insertion rod to slide, valve clamping can be realized quickly, valve capture is facilitated, and operation difficulty is reduced.
Drawings
In order to more clearly illustrate the detailed description of the invention or the technical solutions in the prior art, the drawings that are needed in the detailed description of the invention or the prior art will be briefly described below. Throughout the drawings, like elements or portions are generally identified by like reference numerals. In the drawings, elements or portions are not necessarily drawn to scale.
Fig. 1 is a schematic perspective view of a state of a capturing leaflet according to an embodiment of the present invention.
Fig. 2 is a schematic structural view of a first and second clamping arm of an embodiment of the invention.
Fig. 3 is a schematic diagram of a closed configuration after capturing leaflets, in accordance with an embodiment of the present invention.
Shown in the figure:
1. a first clamping arm; 101. a first clamping tooth;
2. a second clamping arm; 201. a second clamping tooth; 202. fixing teeth; 203. an obtuse slope; 204. a right-angled slope;
3. an expansion arm;
4. inserting a rod;
5. a mounting ring; 501. an external thread;
6. a closed ring; 601. an internal thread.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The following examples are only for illustrating the technical solutions of the present invention more clearly, and therefore are only examples, and the protection scope of the present invention is not limited thereby.
It is to be noted that, unless otherwise specified, technical or scientific terms used herein shall have the ordinary meaning as understood by those skilled in the art to which the invention pertains.
Further, the term "proximal" refers to the end of the surgical procedure that is closer to the operator, and "distal" refers to the end of the surgical procedure that is further from the operator. The terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can include, for example, fixed connections, removable connections, or integral parts; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
As shown in fig. 1 to 3, the present embodiment provides a mitral valve clamping system with an expansion arm 3, which includes a first clamping mechanism, a second clamping mechanism, a connecting mechanism, and an expansion arm 3.
The first clamping mechanism is provided with two first clamping arms 1, the second clamping mechanism is provided with two second clamping arms 2 which correspond to the first clamping arms 1 one by one, and the first clamping arms 1 and the second clamping arms 2 are matched to form the valve clamping device which can be used for clamping the mitral valve. Similarly, three first clamping arms 1 and three second clamping arms 2 can be arranged, and the three first clamping arms and the three second clamping arms are suitable for clamping the tricuspid valve.
First clamping arm 1 and second clamping arm 2 are shape memory elastic material, and under the natural state first clamping arm 1 and second clamping arm 2 open to the outside and extend the setting, but the deformation shrink is convenient for the sheath pipe to be carried, can recover under the shape memory effect and form valve clamping device after reaching the position of intervene.
The connecting mechanism comprises an inserting rod 4 and a mounting ring 5, wherein first clamping arms 1 are uniformly and symmetrically mounted at the far end of the inserting rod 4, the near end of the inserting rod 4 is inserted into an inner hole of the mounting ring 5, second clamping arms 2 are uniformly and symmetrically mounted on the surface of the far end of the mounting ring 5, the second clamping arms 2 are arranged on the outer side of the first clamping arms 1 and are in one-to-one correspondence with the first clamping arms 1, and the inserting rod 4 drives the first clamping arms 1 and the second clamping arms 2 to cooperate to form the valve clamping device along the axial sliding of the mounting ring 5.
The inserted bar 4 is inserted into the mounting ring 5 and slides axially along the mounting ring 5, so that the first clamping arm 1 and the second clamping arm 2 can be driven to open and close, and the valve can be conveniently captured.
When the clamping system intervenes in the sheath, the first clamping arm 1 and the second clamping arm 2 are staggered in a sliding mode through the inserting rod 4, then the first clamping arm 1 and the second clamping arm 2 are compressed, the outer diameter of the clamping system can be effectively reduced, the sheath can be conveniently conveyed, the requirement on the caliber of the sheath can be reduced, and therefore the pain of a patient and the operation difficulty of a surgery can be reduced; after the clamping system is pushed out of the sheath, the first clamping arm 1 and the second clamping arm 2 are everted and matched to form the valve clamp under the shape memory effect.
The lateral surface of first clamp arm 1 evenly is equipped with first clamp tooth 101, and first clamp tooth 101 sets up towards the near-end slope, and the medial surface of second clamp arm 2 evenly sets up second clamp tooth 201, and second clamp tooth 201 is short blunt tooth.
The first clamping teeth 101 are arranged to incline towards one side of the near end, so that the valve can be fixed by the first clamping teeth 101 when being captured, and the inconvenience in operation caused by slippage or unstable fixation of the valve is prevented; the second clamping teeth 201 are arranged to be short blunt teeth to avoid damaging the valve during clamping.
The expansion arm 3 is installed in the second clamping arm 2 side, and the expansion arm 3 extends towards the middle part parcel setting to the outside for the valve of clamping valve clamping ware both sides is in order to increase the clamping scope.
The expansion arm 3 is nickel-titanium alloy expansion arm or shape memory polymer expansion arm, and extends towards middle part parcel setting to the outside under the 3 natural state of expansion arm, consequently the deformation shrink, and the sheath pipe of being convenient for is carried, can recover under the shape memory effect and wrap up the clamping to the valve after arriving the position of mediating, effectively reduces sheath pipe bore demand, alleviates patient's misery and the operation degree of difficulty.
Specifically, the expansion arm 3 is a C-shaped structure in this embodiment, and both ends of the expansion arm 3 are fixed to the side of the second clamping arm 2, and the middle of the expansion arm 3 extends outward and is wrapped towards the middle. The expansion arms 3 may have other shapes such as an O-shaped structure and a knitted structure, and the implementation of the present embodiment is not affected.
When specifically setting up, set up two expansion arm 3 at the bilateral symmetry of second clamping arm 2 to all wrap up the clamping inwards with the valve of both sides, improve the clamping effect.
In order to facilitate adjustment of the clamping angle and control of the clamping system, a closure ring 6 is also provided in this embodiment.
The inner wall of the far end of the closed ring 6 is provided with an internal thread 601, the outer wall of the mounting ring 5 is provided with an external thread 501 matched with the internal thread 601, and the mounting ring 5 slides along the inner hole of the closed ring 6 to drive the first clamping arm 1 and the second clamping arm 2 to adjust the opening angle.
The closing ring 6 is used for connecting with a conveying pipe to push the clamping system, and on the other hand, the closing ring 6 can drive the first clamping arm 1 and the second clamping arm 2 to be folded towards the middle part to control the clamping angle of the valve, so that the clamping capacity and the clamping effect are improved.
The outer side surface of the second clamping arm 2 is uniformly provided with fixing teeth 202 matched with the internal thread 601 along the extension direction of the second clamping arm 2, and the fixing teeth 202 are matched with the internal thread 601 to clamp the second clamping arm 2.
The holding teeth 202 are preferably angled at an obtuse angle 203 on the proximal side and preferably at a right angle 204 on the distal side, although acute angles may be used.
The fixed teeth 202 can cooperate with the internal thread 601 of the closure ring 6 to limit the pinching system, thus maintaining the pinching angle in vivo; the obtuse angle slope 203 facilitates the second clamping arm 2 and the mounting ring 5 to slide towards the near end to draw in the first clamping arm 1 and the second clamping arm 2, and the acute angle slope or the right angle slope 204 is used for clamping the second clamping arm 2 to avoid the mounting ring 5 from sliding towards the far end, so that the mounting ring 5 can slide to draw in the first clamping arm 1 and the second clamping arm 2 gradually according to actual conditions, and the clamping angle can be adjusted.
In order to reduce the influence of the clamping system existing in the body on the patient, the surfaces of the first clamping arm 1, the second clamping arm 2 and the closed ring 6 are coated with a biocompatible PET coating film in the embodiment.
The mitral valve clamping method of the mitral valve clamping system of the present embodiment includes the steps of:
s1, inserting the inserted link 4 into the mounting ring 5, screwing the mounting ring 5 into the closed ring 6, and fixing the mounting ring 5 by matching the internal thread 601 and the external thread 501;
s2, connecting a push rod with the near end of an insert rod 4, connecting a conveying pipe with a closed ring 6, pushing out a first clamping arm 1 to a position staggered with a second clamping arm 2 by using the push rod, compressing an expansion arm 3, the first clamping arm 1 and the second clamping arm 2, and completely inserting a clamping system into a sheath to start intervention;
s3, after the intervention is in place, the first clamping arm 1 and the second clamping arm 2 are pushed out of the sheath tube by the aid of the pushing rod and the conveying pipe, the first clamping arm 1, the second clamping arm 2 and the expansion arm 3 are expanded under the action of shape memory, and the capturing posture is adjusted;
s4, when the mitral valve is positioned between the first clamping arm 1 and the second clamping arm 2, the push rod pulls the insertion rod 4 towards the proximal end, so as to drive the first clamping arm 1 to move towards the proximal end and the second clamping arm 2 to closely match and clamp the mitral valve;
s5, rotating the closed ring 6 through the conveying pipe, screwing the mounting ring 5 into an inner hole of the closed ring 6, pulling the mounting ring 5 towards the near end by using the pushing rod, driving the first clamping arm 1 and the second clamping arm 2 to contract to clamp the mitral valve, wrapping and clamping the mitral valves at two sides towards the middle part by the expansion arm 3, and pushing the closed ring 6 to adjust the contraction clamping angle so as to control the clamping force;
and S6, after the clamping angle is adjusted, separating the push rod from the inserted rod 4, separating the conveying pipe from the closed ring 6, and withdrawing the push rod, the conveying pipe and the sheath pipe to complete the mitral valve clamping.
The expanding arm 3 is arranged on the side surface of the second clamping arm 2, and the expanding arm 3 wraps the valve on the side surface of the clamping area towards the middle part, so that the clamping range is effectively improved, and the problem of backflow leakage on two sides of the clamp is avoided;
the expansion arm 3, the first clamping arm 1 and the second clamping arm 2 are made of shape memory materials, can deform and contract, are convenient for conveying a sheath, and can recover under the shape memory effect to wrap and clamp a valve after reaching a intervention position, so that the requirement on the caliber of the sheath is effectively reduced, and the pain of a patient and the operation difficulty are relieved;
in the embodiment, the first clamping arm 1 and the second clamping arm 2 are connected by adopting the structure of the inserted rod 4 and the mounting ring 5, and the first clamping arm 1 and the second clamping arm 2 can be staggered in a sliding way through the inserted rod 4 during conveying, so that the outer diameters of the first clamping arm 1 and the second clamping arm 2 in a compressed state are effectively reduced, the conveying of a sheath tube is facilitated, the requirement on the caliber of the sheath tube is effectively reduced, and the pain of a patient and the operation difficulty are reduced;
the closing ring 6 of the embodiment is used for connecting the pushing clamping system with the pushing rod, and on the other hand, the closing ring 6 can drive the first clamping arm 1 and the second clamping arm 2 to be folded towards the middle part to control the clamping angle of the valve, so that the clamping capability and the clamping effect can be improved;
in this embodiment, the outer side surface of the second clamping arm 2 is further uniformly provided with fixing teeth 202 matched with the internal threads 601, the fixing teeth 202 can be matched with the internal threads 601 of the closing ring 6 to limit the clamping system, so that the clamping angle is maintained in the body, an obtuse slope 203 on one side surface of the fixing teeth 202 is convenient for the second clamping arm 2 to slide and draw the first clamping arm 1 and the second clamping arm 2 towards the near end, and an acute slope or a right slope 204 on the other side surface is used for clamping the second clamping arm 2 to avoid the installation ring 5 from sliding towards the far end, so that the installation ring 5 can be slid to gradually draw the first clamping arm 1 and the second clamping arm 2 to adjust the clamping angle according to the actual situation;
the push rod controls the insertion rod 4 to slide, so that the valve can be clamped quickly, the valve can be captured conveniently, and the operation difficulty can be reduced.
In the description of the present invention, numerous specific details are set forth. It is understood, however, that embodiments of the invention may be practiced without these specific details. In some instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.
In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples and features of different embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention, and they should be construed as being included in the following claims and description.

Claims (11)

1. A mitral valve clamping system with an expansion arm, comprising:
a first clamping mechanism having at least two first clamping arms;
the second clamping mechanism is provided with a plurality of second clamping arms which correspond to the first clamping arms one by one;
the connecting mechanism is used for connecting the first clamping mechanism and the second clamping mechanism;
the expansion arm is arranged on the side surface of the second clamping arm, extends outwards and is wrapped towards the middle part;
wherein, the first clamping arm and the second clamping arm are matched to form a valve clamping device, and the expansion arm is used for clamping valves on two sides of the valve clamping device so as to increase the clamping range.
2. The mitral valve clamping system with an expansion arm according to claim 1, wherein the expansion arm is a nitinol expansion arm or a shape memory polymer expansion arm, and the expansion arm naturally extends outward and wraps around the middle.
3. The mitral valve clamping system with an expansion arm according to claim 2, wherein the expansion arm has a C-shaped structure or an O-shaped structure, and one side of the expansion arm is fixed to the side of the second clamping arm, and the other side of the expansion arm extends outward and wraps the second clamping arm toward the middle.
4. The mitral valve clamping system with expansion arms of claim 1, wherein the expansion arms are symmetrically disposed on both sides of the second clamping arm.
5. The mitral valve clamping system with an expansion arm according to claim 1, wherein the connecting mechanism comprises an insertion rod and a mounting ring, the first clamping arms are uniformly and symmetrically mounted at the distal end of the insertion rod, the proximal end of the insertion rod is inserted into the inner hole of the mounting ring, the second clamping arms are uniformly and symmetrically mounted on the surface of the distal end of the mounting ring, the second clamping arms are arranged outside the first clamping arms in a one-to-one correspondence with the first clamping arms, and the insertion rod slides axially along the mounting ring to drive the first clamping arms and the second clamping arms to cooperate to form the valve clamp.
6. The mitral valve clamping system with expansion arms of claim 5, wherein the first clamping arm and the second clamping arm are made of shape memory elastic materials, and the first clamping arm and the second clamping arm are arranged in an outward-opening extending manner in a natural state.
7. The mitral valve clamping system with an expansion arm according to claim 6, wherein the outer side surface of the first clamping arm is uniformly provided with first clamping teeth, the first clamping teeth are obliquely arranged towards the proximal end, the inner side surface of the second clamping arm is uniformly provided with second clamping teeth, and the second clamping teeth are short blunt teeth.
8. The mitral valve clamping system with expansion arms of claim 5, further comprising a closed ring, wherein the inner wall of the distal end of the closed ring is provided with an internal thread, the outer wall of the mounting ring is provided with an external thread matching the internal thread, and the mounting ring slides along the inner hole of the closed ring to drive the first clamping arm and the second clamping arm to adjust the opening angle.
9. The mitral valve clamping system with an expansion arm according to claim 8, wherein the second clamping arm outer side surface is uniformly provided with fixing teeth matched with the internal thread along the extension direction of the second clamping arm, the fixing teeth are matched with the internal thread to clamp the second clamping arm, and the fixing teeth are an obtuse-angle slope towards the proximal side surface and an acute-angle slope or a right-angle slope towards the distal side surface.
10. The mitral valve clamping system with expansion arms of claim 8, wherein the first clamping arm, second clamping arm, and closure ring are surface coated with a biocompatible PET coating.
11. A mitral valve clamping method using the mitral valve clamping system with an expansion arm according to any one of claims 1 to 10, comprising the steps of:
s1, inserting the inserted rod into the mounting ring, and screwing the mounting ring into the closed ring, wherein the internal thread and the external thread are matched to fix the mounting ring;
s2, connecting a push rod with the near end of the insertion rod, connecting a delivery pipe with the closed ring, pushing the first clamping arm out to a position where the first clamping arm and the second clamping arm are not overlapped, compressing the expansion arm, the first clamping arm and the second clamping arm, inserting the clamping system into the sheath tube completely, and starting intervention;
s3, after the intervention is in place, the first clamping arm and the second clamping arm are pushed out of the sheath tube by the aid of the pushing rod and the conveying pipe, and the first clamping arm, the second clamping arm and the expanding arm are expanded under the action of shape memory and adjusted to capture postures;
s4, when the mitral valve is between the first clamping arm and the second clamping arm, the push rod pulls the insertion rod towards the near end to drive the first clamping arm to move towards the near end and the second clamping arm to clamp the mitral valve in a matching way;
s5, rotating the closed ring through the conveying pipe, rotating the installation ring into the inner hole of the closed ring, pulling the installation ring towards the near end by using the pushing rod, driving the first clamping arm and the second clamping arm to contract to clamp the mitral valve, wrapping and clamping the mitral valves at two sides towards the middle by the expanding arm, and pushing the closed ring to adjust the contraction clamping angle to control the clamping force;
and S6, after the clamping angle is adjusted, separating the push rod and the insertion rod, separating the conveying pipe and the closed ring, and withdrawing the push rod, the conveying pipe and the sheath pipe to complete the mitral valve clamping.
CN202110251655.6A 2021-03-08 2021-03-08 Mitral valve clamping system with expansion arm and mitral valve clamping method Pending CN113017924A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113749823A (en) * 2021-10-12 2021-12-07 科凯(南通)生命科学有限公司 Mitral valve repair clamp connected with conveying structure in clamping manner
CN113796993A (en) * 2021-10-12 2021-12-17 科凯(南通)生命科学有限公司 Clamp for repairing mitral valve stably in clamping manner
CN113876469A (en) * 2021-10-12 2022-01-04 科凯(南通)生命科学有限公司 Mitral valve repair clamp convenient to push
WO2023010284A1 (en) * 2021-08-03 2023-02-09 上海形状记忆合金材料有限公司 Heart valve clamp and manufacturing method therefor
WO2023091520A1 (en) * 2021-11-19 2023-05-25 Edwards Lifesciences Corporation Heart valve repair devices

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023010284A1 (en) * 2021-08-03 2023-02-09 上海形状记忆合金材料有限公司 Heart valve clamp and manufacturing method therefor
CN113749823A (en) * 2021-10-12 2021-12-07 科凯(南通)生命科学有限公司 Mitral valve repair clamp connected with conveying structure in clamping manner
CN113796993A (en) * 2021-10-12 2021-12-17 科凯(南通)生命科学有限公司 Clamp for repairing mitral valve stably in clamping manner
CN113876469A (en) * 2021-10-12 2022-01-04 科凯(南通)生命科学有限公司 Mitral valve repair clamp convenient to push
CN113749823B (en) * 2021-10-12 2023-06-27 科凯(南通)生命科学有限公司 Mitral valve repair clamp connected with conveying structure in clamping mode
CN113876469B (en) * 2021-10-12 2023-06-27 科凯(南通)生命科学有限公司 Mitral valve repair fixture convenient to push
CN113796993B (en) * 2021-10-12 2023-07-07 科凯(南通)生命科学有限公司 Mitral valve repair clamp with stable clamping
WO2023091520A1 (en) * 2021-11-19 2023-05-25 Edwards Lifesciences Corporation Heart valve repair devices

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