CN114762635A - Valve clamping device and valve clamping system with full fitting - Google Patents

Valve clamping device and valve clamping system with full fitting Download PDF

Info

Publication number
CN114762635A
CN114762635A CN202110057563.4A CN202110057563A CN114762635A CN 114762635 A CN114762635 A CN 114762635A CN 202110057563 A CN202110057563 A CN 202110057563A CN 114762635 A CN114762635 A CN 114762635A
Authority
CN
China
Prior art keywords
clamping device
valve
section
valve clamping
clamping
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202110057563.4A
Other languages
Chinese (zh)
Inventor
张庭超
张伟伟
郑贤章
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Valgen Medtech Co Ltd
Original Assignee
Hangzhou Valgen Medtech Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hangzhou Valgen Medtech Co Ltd filed Critical Hangzhou Valgen Medtech Co Ltd
Priority to CN202110057563.4A priority Critical patent/CN114762635A/en
Priority to EP21770911.2A priority patent/EP4122426A4/en
Priority to US17/906,641 priority patent/US20230157819A1/en
Priority to BR112022018791A priority patent/BR112022018791A2/en
Priority to PCT/CN2021/081606 priority patent/WO2021185324A1/en
Publication of CN114762635A publication Critical patent/CN114762635A/en
Pending legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • 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

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 invention discloses a valve clamping device and a valve clamping system which are fully attached. The valve clamping device which is fully attached comprises a supporting part, an adjusting part and a clamping part. The support part has a certain axial length and comprises a first end and a second end which are oppositely arranged; the adjusting part comprises a first end and a second end which are oppositely arranged, and a self-expanding main body positioned between the first end and the second end; the first end of the adjusting part is movably sleeved on the outer side of the supporting part, the second end of the adjusting part is sleeved on the outer side of the supporting part and is fixedly connected with the supporting part, and the first end of the adjusting part is positioned between the first end of the supporting part and the second end of the adjusting part; the clamping part is arranged on the outer side of the supporting part and can be unfolded or closed relative to the adjusting part. The valve clamping device with sufficient fitting can increase the fitting area of the valve leaflet and the adjusting part, so that the valve leaflet and the adjusting part are sufficiently fitted, and the clamping force is further improved to firmly clamp the valve leaflet.

Description

Valve clamping device and valve clamping system with full fitting
Technical Field
The application relates to the technical field of interventional medical devices, in particular to a valve clamping device and a valve clamping system which are sufficiently attached.
Background
Referring to fig. 1, the mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart, and the normal healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3, and prevent the blood flow from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a posterior leaflet 1 b. The anterior 1a and posterior 1b leaflets are fixed to papillary muscles of the left ventricle 3 by chordae tendineae 4. Normally, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely apposed, preventing blood from flowing from the left ventricle 3 to the left atrium 2. Referring to fig. 2, when the leaflets or related structures of the mitral valve 1 are organically or functionally changed, such as the chordae tendineae 4 are partially broken, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are not properly aligned, so that when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, resulting in the regurgitation of blood from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".
Interventional mitral valvuloplasty refers to the treatment of mitral regurgitation by implanting a valve clamping device into the mitral valve, using a pair of closable clamping arms to pull the anterior and posterior leaflets towards each other, reducing or eliminating the leaflet gap. Fig. 3 and 4 show a conventional valve clamping device 90, which adds an elastic net 93 to two clamp arms 91, and the leaflet L of each side is clamped between one clamp arm 91 and one side of the elastic net 93, and the leaflet L is adjusted in the space between the leaflets by the deformation of the elastic net 93, so as to adjust the degree of pulling of the clamp arms 91 on the leaflet L. One end 931 of the elastic net 93 is fixedly connected to a first end 951 of the support 95 through a steel sleeve or other end socket (the first end 951 refers to an end of the support 95 near the rotary connection portion of the two clamp arms 91), and the other end 933 of the elastic net 93 is a free end movably surrounding the support 95. When the two clamp arms 91 are closed, the elastic net 93 is squeezed to deform, because the seal heads 97 limit the axial movement of one end 931 of the elastic net 93, the elastic net 93 extends towards the free end 933 in the axial direction, at the same time, the two sides of the elastic net 93 squeezed by the two clamp arms 91 are retracted in the radial direction, the free end 933 of the elastic net 93 and the parts nearby the free end 933 are gradually folded towards the central axis of the elastic net 93 under the influence of the retracted parts, so that a radial gap X exists between the free end 933 of the elastic net 93 and the parts nearby the free end 933 and the valve leaflet L, that is, the valve leaflet L cannot be attached to the free end 933 of the elastic net 93 and the parts nearby the valve leaflet L, the elastic attachment area of the valve leaflet L and the elastic net 93 is limited, accordingly, the free end 933 of the elastic net 93 and the parts nearby the free end 933 cannot provide radial supporting force for the valve leaflet L, and the clamping force of the clamp arms 91 and the elastic net 93 to the valve leaflet L may be insufficient, there is a risk that the leaflets L fall out from between the forceps arms 91 and the elastic mesh 93, affecting the implantation stability of the valve clamping device; meanwhile, the radial gap X between the free end 933 of the elastic net 93 and the portion in the vicinity thereof and the leaflet L allows blood regurgitated from the occlusion gap to permeate therethrough, affecting the regurgitation treatment effect.
Disclosure of Invention
To address the above technical problems, or at least partially solve the above technical problems, the present application provides a valve clamping device and a valve clamping system with sufficient fit.
In a first aspect, the present application provides a substantially conformable valve clamping device comprising:
a support portion having an axial length and including first and second ends disposed in opposition;
an adjustment portion comprising first and second oppositely disposed ends and a self-expanding body located between the first and second ends; the first end of the adjusting part is movably sleeved on the outer side of the supporting part, the second end of the adjusting part is sleeved on the outer side of the supporting part and is fixedly connected with the supporting part, and the first end of the adjusting part is positioned between the first end of the supporting part and the second end of the adjusting part;
the clamping part is arranged on the outer side of the supporting part and can be unfolded or closed relative to the adjusting part.
In a second aspect, the present application provides a valve clamping system comprising a substantially conformable valve clamping device as described above, and a delivery device, wherein the delivery device comprises: the pushing sheath tube is provided with a certain axial length, and the mandrel is movably arranged in the pushing sheath tube in a penetrating mode, the pushing sheath tube is detachably connected with the supporting portion, and the mandrel is used for driving the clamping portion to be unfolded and closed.
The application provides a valve clamping device and valve clamping system, will the second pot head of regulating part establish the outside of supporting part and with supporting part fixed connection, will the first end activity cover of regulating part is established the outside of supporting part, and will the first end of regulating part is located the first end of supporting part with between the second end of regulating part, work as the clamping part is relative the regulating part is closed in order to with the leaflet centre gripping in the self-expanding main part of regulating part with between the clamping part, the second end of regulating part and near part are limited from the axial motion of expanding the main part, and the self-expanding main part can be towards the first end extension of regulating part in the axial, simultaneously the self-expanding main part receives the extrusion of clamping part can radially retract, is along with the first end of regulating part extends towards the valve margin of leaflet, and the self-expanding main part folds towards the axis of regulating part gradually, the part of the self-expanding main body near the second end of the adjusting part can be tightly attached to the valve leaflet without a radial gap, compared with the prior art, the attaching area of the valve leaflet and the adjusting part can be increased, so that the valve leaflet is fully attached to the adjusting part, correspondingly, the second end of the adjusting part and the part of the self-expanding main body near the second end of the adjusting part can provide radial supporting force for the valve leaflet, the clamping force is further improved so as to firmly clamp the valve leaflet, the risk that the valve leaflet falls off from the clamping part and the adjusting part is reduced, and the implantation stability of the valve clamping device is improved; simultaneously, the portion near the regulation part second end is from the laminating of closely between expansion main part and the leaflet can the shutoff from the palirrhea blood in clamping clearance, optimizes palirrhea treatment.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments of the invention and together with the description, serve to explain the principles of the invention.
In order to more clearly illustrate the embodiments or technical solutions in the prior art of the present invention, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art to obtain other drawings without inventive labor.
FIG. 1 is a schematic view of a mitral valve in a normal state;
FIG. 2 is a schematic representation of a diseased mitral valve;
FIG. 3 is a schematic view of a prior art valve clamping device;
FIG. 4 is a schematic view of the valve clasping device shown in FIG. 3 in a state of clasping leaflets;
FIG. 5 is a schematic view of the structure of a valve clamping device according to a first embodiment of the invention;
FIG. 6 is a schematic view of the structure of FIG. 5 after the adjustment part and the support part are combined;
FIG. 7 is a schematic view of the combined structure of the adjustment part and the fixing member of FIG. 5;
FIG. 8a is a schematic perspective view of the adjustment part of FIG. 5 from a viewing angle;
FIG. 8b is a schematic perspective view of the adjustment part of FIG. 5 from another perspective;
FIG. 9 is a schematic view of the valve clasping device of FIG. 5 in a state of clasping leaflets;
FIG. 10 is a schematic view of the combined structure of the nip portion and the driving portion of FIG. 5;
FIG. 11 is a schematic view of the support portion of FIG. 5;
FIG. 12 is a schematic view of the support portion of FIG. 5 engaged with the base;
FIG. 13 is a schematic view of the valve clamping device of FIG. 5 with the support portion engaged with the delivery device;
FIGS. 14-18 are schematic illustrations of a procedure for anterograde approach through the left atrium and performing edge-to-edge repair of the mitral valve using the valve clamping device of FIG. 5;
FIG. 19 is a schematic view of a valve clasping device of a second embodiment of the present application;
FIG. 20 is a schematic view of the adjustment part and the support part of FIG. 19 assembled together;
FIG. 21 is a schematic view of the adjustment portion and the fixing member of FIG. 19 in combination;
fig. 22 is a schematic view of the valve clamping device of the third embodiment of the present application in a state of clamping leaflets;
FIG. 23 is a schematic view of a fourth embodiment of the present application showing the construction of a valve clamping device;
FIG. 24 is a schematic view of the support, drive and clamping portions of FIG. 23 in combination;
FIG. 25 is a schematic view of the valve coaptation device of FIG. 23 in a position to clamp the valve leaflets;
FIG. 26 is a schematic view of a fifth embodiment of the valve clasping apparatus of the present application;
FIG. 27 is a schematic view of a sixth embodiment of the present application showing the construction of a valve clamping device;
FIG. 28 is a schematic view of the support, drive and clamping portions of FIG. 27 in combination;
FIG. 29 is a schematic view of a valve clasping device of a seventh embodiment of the present application;
FIG. 30 is a schematic view of a delivery device coupled to a valve clamping device according to an eighth embodiment of the present application;
fig. 31 is a schematic illustration of the valve clamping device of fig. 30 approaching a mitral valve via an apical approach.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.
In the description of the present invention, it is to be noted that:
the terms "upper", "lower", "inner", "outer", and the like, indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred devices or elements must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Moreover, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance;
when an element is referred to as being "secured to" or "disposed on" another element, it can be directly connected to the other element or be indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be connected to the other element through one or more connecting elements.
It should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the direction of a rotating central shaft of an object such as a column body, a pipe body and the like is defined as an axial direction; the circumferential direction is the direction around the axis of an object such as a column, a pipe body and the like (perpendicular to the axis and the radius of the section); radial refers to the direction along a diameter or radius. It is noted that the term "end" as used herein, whether in the context of "proximal end", "distal end", "one end", "another end", "first end", "second end", "initial end", "terminal end", "two ends", "free end", "upper end", "lower end", and the like, is not limited to a tip, end or end surface, but also includes a portion extending an axial distance and/or a radial distance from the tip, end or end surface over the component to which the tip, end or end surface pertains. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.
Example one
Referring to fig. 5 to 9, a first embodiment of a fully conformable valve clamping device 100 according to the present invention comprises:
a support portion 110, the support portion 110 having an axial length and including a first end 111 and a second end 115 disposed opposite to each other;
an adjustment part 120, the adjustment part 120 including a first end 121 and a second end 123 disposed oppositely, and a self-expanding body 125 between the first end 121 and the second end 123;
and a clamping portion 130, wherein the clamping portion 130 is arranged outside the adjusting portion 120 and can be opened or closed relative to the adjusting portion 120.
The first end 121 of the adjusting portion 120 of the valve clamping device 100 is movably sleeved on the outer side of the supporting portion 110, and the second end 123 of the adjusting portion 120 is sleeved on the outer side of the supporting portion 110 and is fixedly connected with the supporting portion 110. The first end 121 of the adjustment portion 120 is located between the first end 111 of the support portion 110 and the second end 123 of the adjustment portion 120, or the first end 121 of the adjustment portion 120 is closer to the first end 111 of the support portion 110 than the second end 123 of the adjustment portion 120.
With reference to fig. 5 and 14-18, the valve clamping device 100 of the first embodiment is provided with a connecting portion (not shown) at the second end 115 of the supporting portion 110 for detachably connecting (e.g., screwing, snapping, etc.) with the delivery device 200, the delivery device 200 pushes the valve clamping device 100 into the heart through the catheter, the second end 115 of the supporting portion 110 is a proximal end thereof, the first end 111 of the supporting portion 110 is a distal end thereof, the second end 123 of the adjusting portion 120 is a proximal end thereof, and the first end 121 of the adjusting portion 120 is a distal end thereof. It will be appreciated that in other embodiments, the valve clamping device may be transapically accessible to the heart, and the second end of the support portion is its distal end, the first end of the support portion is its proximal end, the second end of the adjustment portion is its distal end, and the first end of the adjustment portion is its proximal end.
Referring to fig. 5-9, the valve clamping device 100 mainly includes two states, i.e., a deployed state and a closed state. In the unfolded state, the adjusting portion 120 is in a natural state without being subjected to an external force, the first end 121 of the self-expandable main body 125 of the adjusting portion 120 in the natural state gradually increases toward the second end 123 of the adjusting portion 120, that is, the overall external shape of the adjusting portion 120 is approximately in the shape of an inverted cone, the first end 121 of the adjusting portion 120 approximately forms the apex of the inverted cone, and the portion near the second end 123 of the adjusting portion 120 forms the bottom of the inverted cone. In the first embodiment, one end of the clamping portion 130 is rotatably connected to the first end 111 of the supporting portion 110, so that the clamping portion 130 can be opened or closed around the adjusting portion 120 and around the rotating connection portion with the first end 111 of the supporting portion 110, and an axial distance is formed between the first end 121 of the adjusting portion 120 and the first end 111 of the supporting portion 110, so that when the adjusting portion 120 is radially pressed, the first end 121 of the adjusting portion 120 can axially move toward the first end 111 of the supporting portion 110, and when the clamping portion 130 is closed around the adjusting portion 120 and around the rotating connection portion with the first end 111 of the supporting portion 110, the adjusting portion 120 is pressed by the clamping portion 130 to generate radial retraction and axial extension phenomena. It is understood that in other embodiments, one end of the clamping portion 130 can be rotatably connected to other components as long as the component is close to the first end 111 of the supporting portion 110, so that the clamping portion 130 is disposed outside the supporting portion 110 and can be opened or closed relative to the adjusting portion 120 to clamp the valve leaflet.
It should be noted that, in the closed state, since the second end 123 of the adjusting portion 120 is fixedly connected to the supporting portion 110, the first end 121 of the adjusting portion 120 is movably sleeved on the supporting portion 110, the second end 123 of the adjusting portion 120 and the portion near the second end 123 of the adjusting portion 120 are limited in axial movement from the expanding body 125, the expanding body 125 can extend in the axial direction toward the first end 121 of the adjusting portion 120, and the expanding body 125 can retract in the radial direction under the compression of the clamping portion 130, and along with the extension of the first end 121 of the adjusting portion 120 toward the valve edge of the valve leaflet 1, the overall shape of the adjusting portion 120 can be complementary to the shape of the opening portion of the clamping portion 130, and still presents an inverted cone shape. The part near the second end 123 of the adjusting part 120 is located at the conical bottom of the inverted cone from the expanding main body 125, that is, the part near the second end 123 of the adjusting part 120 gradually converges toward the central axis of the adjusting part 120 from the expanding main body 125, and the part near the second end 123 of the adjusting part 120 can be tightly attached to the leaflet 1 without a radial gap from the expanding main body 125. Accordingly, the second end 123 of the adjustment portion 120 and the portion of the self-expandable body 125 near the second end can provide a larger radial supporting force for the leaflet 1, so as to improve the clamping force to firmly clamp the leaflet 1, reduce the risk of the leaflet 1 falling off from between the clamping portion 130 and the adjustment portion 120, and improve the implantation stability of the valve clamping device 100; meanwhile, the close fit between the part of the self-expanding main body 125 near the second end 123 of the adjusting part 120 and the valve leaflet 1 can block the regurgitated blood from the clamping gap, and the regurgitation treatment effect is optimized. In addition, the adjusting part 120 can adjust its shape adaptively according to the difference of the clamping degree of the clamping part 130, and can ensure that the leaflet can be attached sufficiently under any clamping degree.
It can be understood that, in the closed state, the first end 121 of the adjusting part 120 can extend towards the valve edge to be closer to the valve edge position than the prior art, so that the fitting area of the valve leaflet 1 and the adjusting part 120 is further increased, and the elastic fitting performance of the valve leaflet 1 and the adjusting part 120 is further improved.
In addition, since the first end 121 of the adjusting part 120 is movably sleeved on the supporting part 110, the adjusting part 120 has strong axial deformability, and when the valve clamping device 100 is radially compressed into a delivery sheath for in vivo delivery, the valve clamping device is easily compressed into the sheath.
Specifically, referring to fig. 5 and 10-13, the supporting portion 110 may be a circular tube, a square tube, or a flat tube, etc. with two axially penetrating end surfaces. This embodiment uses a tubular body, and as mentioned above, the distal end of the tubular body is the first end 111, and the proximal end is the second end 115. The second end 115 of the support part 110 is surrounded and shielded by the main expansion body 125 in the vicinity of the second end 123 of the adjuster 120 in both the closed state and the expanded state, so that the adjuster 120 is not exposed, the second end 115 is prevented from directly contacting the leaflet, the second end 115 is prevented from wearing the leaflet with a long-term pulsation of the leaflet, and the implantation safety is improved.
The support portion 110 is further provided with an axial through-hole shaped through-passage 113 for cooperating with the driving portion 140 and the delivery device 200. At least two clamping positions 114 are arranged on the pipe wall of the round pipe body of the supporting part 110 and are used for being detachably connected with the conveying device 200. For example, the delivery device 200 is provided with the retainer 221, and after the retainer 221 is engaged with the retainer 114, the delivery device 200 is engaged with the support 110, so that the valve clamping device 100 can be delivered, and when the retainer 221 is disengaged from the retainer 114, the delivery device 200 is separated from the valve clamping device 100. It should be understood that the structure of the supporting portion 110 is only used as an example and is not limited to the present application, and other structures of the supporting portion 110 adopted by those skilled in the art based on the teachings of the present application are within the protection scope of the present application.
Referring to fig. 5-9, the self-expanding body 125 of the adjustment part 120 is a net structure, preferably a net structure woven from wire materials having shape memory function or cut from tube materials, such as super elastic materials like nickel-iron alloy wire. Under the same degree of closure of the clamping part 130, the adjusting part 120 can adapt to the space between different valve leaflets and deform adaptively, so as to adjust the degree of traction of the valve clamping device 100 on the valve leaflets. The adjusting portion 120 has a hollow accommodating cavity (not labeled), and a portion of the supporting portion 110 between the second end 115 and the first end 111 is disposed in the hollow accommodating cavity.
The self-expanding body 125 includes a first section 124, a second section 126, and a third section 128 connected in series. The first section 124 extends from the second end 123 of the adjustment part 120 towards the second end 115 of the support part 110, and the first section 124 forms a bowl-like depression 122 (as shown in fig. 7 and 8 a) relative to the second section 126, the first section 124 surrounds the outside of the second end 115 of the support part 110, or the second end 115 of the support part 110 is located in the depression 122, and the second end 115 of the support part 110 can be surrounded and shielded by the first section 124 of the self-expanding body 125 in both the closed state and the expanded state of the valve clamping device 100, so that the adjustment part 120 is not exposed. The second section 126 continues radially outward from the first section 124. The third section 128 terminates from the second section 126 toward the first end 111 of the support portion 110 while extending radially inward to the first end 121 of the accommodating portion 12. In the first embodiment, the end of the recessed area 122 (the end of the first section 124 close to the second end 123 of the adjusting part 120 is defined as the end of the recessed area 122) extends towards the first end 111 of the supporting part 110 to the second end 123 of the adjusting part 120.
When the adjusting part 120 is manufactured, firstly, a woven net tube with two open ends is prepared, one end of the woven net tube is sleeved on a lining rod, and then a forming sleeve is sleeved outside one end of the woven net tube to form a second end 123 of the adjusting part 120; then the other end of the woven mesh pipe is pulled outwards and downwards simultaneously, so that the woven mesh pipe is turned outwards to the forming die; then, heat setting treatment is carried out to form the adjusting part 120 which is approximately inverted cone-shaped in overall appearance as shown in fig. 8a to 8b, the first end 121 with an opening of the adjusting piece 120 is formed below one end of the woven mesh pipe at the other end of the woven mesh pipe, and the forming sleeve and the forming die are taken down to obtain the adjusting part 120.
When the adjusting portion 120 is assembled with the supporting portion 110, a portion between the second end 115 and the first end 111 of the supporting portion 110 is inserted into the hollow accommodating cavity of the adjusting portion 120, the second end 123 of the adjusting portion 120 is fixedly connected with the supporting portion 110 through the fixing member 80, the fixing member 80 may be a steel sleeve, the second end 123 of the adjusting portion 120 is inserted between the steel sleeve and the outer surface of the supporting portion 110, and the second end 123 of the adjusting portion 120 is fixedly connected with the supporting portion 110 by laser welding the steel sleeve and the supporting portion 110. It is understood that, in other embodiments, the fixing member 80 may not be provided, and the second end 123 of the adjusting portion 120 may be directly fixedly connected to the supporting portion 110 by welding. In this embodiment, the second end 123 of the adjusting portion 120 is inserted into the fixing member 80 toward the first end 111 of the supporting portion 110, and if the second end 123 of the adjusting portion 120 is located at the upper position and the first end 121 of the adjusting portion 120 is located at the lower position in fig. 6, the second end 123 of the adjusting portion 120 is inserted into the fixing member 80 from the top to the bottom. The first end 121 of the adjusting portion 120 may have an opening with a diameter equal to or slightly larger than that of the supporting portion 110 so as to be movably sleeved on the supporting portion 110, so that the first end 121 of the adjusting portion 120 can smoothly slide along the axial direction of the supporting portion 110. In addition, since the second end 123 of the adjusting portion 120 is fixedly connected to the supporting portion 110, and the first end 121 of the adjusting portion 120 is movably sleeved on the supporting portion 110, the center of gravity of the whole valve clamping device 100 is always located in the axial direction of the supporting portion 110, and therefore the self-centering performance is good, and the valve clamping device is not prone to tilt.
More specifically, during the transition from the expanded state to the closed state of the valve clamping device 100, the radial dimension (indicated by D in fig. 6) of the second section 126 of the self-expandable body 125 is preferably in the range of 4mm to 15mm, more preferably 5mm to 10mm, and the radial dimension of the first end 121 of the adjusting part 120 is in the range of 1mm to 5mm, more preferably 1.2mm to 3mm, so that the inverted cone shape of the adjusting part 120 as a whole can be compressed to adapt to the space between different valve leaflets and have the largest possible fitting area with the valve leaflets.
With reference to fig. 5, 6 and 9, in the closed state of the valve clamping device 100, i.e. when the leaflet 1 is clamped between the adjustment portion 120 and the clamping portion 130, since the second end 123 of the adjustment portion 120 is fixedly connected to the support portion 110, the first end 121 of the adjustment portion 120 is movably sleeved on the support portion 110, the second end 123 of the adjustment portion 120, the first section 124 and the second section 126 of the self-expanding body 125 are limited in axial movement, the adjustment portion 120 is elongated in the axial direction towards the first end 121 thereof, while the self-expanding body 125 is radially retracted by the clamping portion 130 under the compression of the clamping portion 130, but the first section 124 resists inward deformation of the second section 126, the second section 126 transmits this resisting action to the corresponding portion of the third section 128 connected thereto, and along with the first end 121 of the adjustment portion 120 extending towards the leaflet edge of the leaflet 1, the overall shape of the adjustment portion 120 presents an inverted conical shape complementary to the shape at the opening portion 130, the second section 126 is located at the bottom of the inverted cone, the third section 128 gradually converges from the second section 126 to the first end 121 toward the central axis of the adjustment portion 120, the entire section of the third section 128 of the self-expandable body 125 can be tightly attached to the leaflet 1 without a radial gap, the elastic attachment between the leaflet 1 and the adjustment portion 120 is improved, and the leaflet 1 and the adjustment portion 120 can be fully attached. Accordingly, the adjustment part 120 can provide a greater radial supporting force to the leaflet 1, thereby improving a clamping force to firmly clamp the leaflet 1. As shown in fig. 9, the second section 126 of the self-expanding body 125 is not lower than the end surface of the free end of the clamping portion 130 when closed, so that the leaflet 1 clamped between the clamping portion 130 and the adjustment portion 120 has a length substantially equal to that of the clamping portion 130.
It is understood that in other embodiments, the regulating part 120 of the mesh structure may be covered with a biocompatible film on the outside and/or inside, which may serve as a flow blocking film to block the regurgitated blood from the clamping gap, improve the regurgitation treatment effect, and prevent the blood from entering into the regulating part 120 to form thrombus, on the one hand, and may make the valve clamping device 100 more biocompatible. The material of the film can be, but is not limited to, a biocompatible polymer such as PTFE, EPTFE, polyester, silicone, and the like.
Certainly, the adjusting portion 120 is not limited to be a mesh structure, and may also be another hollow structure having elasticity and self-expandable, for example, the adjusting portion may be a silica gel body with a compact structure or a sponge body with a porous structure, the second end of the adjusting portion with a compact structure or a porous structure is fixedly sleeved on the supporting portion 110, the first end is axially movably sleeved on the supporting portion 110, similarly, a similar first section, a similar second section, and a similar third section may be provided between the second end and the first end, and the valve leaflet may be sufficiently attached to the adjusting portion based on the same operation principle.
Referring to fig. 5, and 9-13, the clamping portion 130 includes at least two arms 131, and may generally include at least one set of arms 131, where each set of arms 131 includes two arms 131 symmetrically disposed with respect to the adjustment portion 120. The clamping portion 130 of the present embodiment includes a set of clamp arms 131, and it should be understood that this is merely an example, and one skilled in the art can select an appropriate number of clamp arms 131, such as two or more sets of clamp arms, as desired. It will be appreciated that three or more clamp arms 131 may also be provided in each set as desired, for example, three leaflets of the tricuspid valve may be simultaneously clamped by the three relatively openable and closable clamp arms 131 to treat tricuspid regurgitation; or a pair of clamp arms 131 can be used for clamping two valve leaflets of the tricuspid valve, so that the purpose of reducing or treating the tricuspid regurgitation can be achieved.
In this embodiment, the valve clamping device 100 further comprises an actuating portion 140, and the actuating portion 140 is connected to the clamping portion 130 to actuate the clamping portion 130 to open or close relative to the adjusting portion 120. Specifically, the driving portion 140 is connected to each of the pair of jawarms 131, for example, the driving portion 140 is connected to two jawarms 131 of the set of jawarms 131, respectively, to drive each of the jawarms 131 to rotate around the adjustment portion 120, thereby moving the jawarms 131 closer to or away from the adjustment portion 120. In the delivery state, the driving part 140 drives the forceps arms 131 to close around the adjusting part 120, so as to reduce the outer diameter of the valve clamping device 100 and facilitate delivery; after the valve clamping device 100 is deployed in the heart, the driving portion 140 drives the clamp arms 131 to clamp the valve leaflets between the clamp arms 131 and the adjusting portion 120, so as to clamp the valve leaflets.
In a preferred embodiment of the present embodiment, the valve clamping device 100 further comprises a gripping portion, which may generally comprise at least one set of gripping arms 151, and each set of gripping arms 151 comprises two gripping arms 151 symmetrically disposed with respect to the regulating portion 120. The grip portion (e.g., the grip arm 151) is disposed between the clamping portion 130 (e.g., the clamp arm 131) and the adjustment portion 120 and is expandable or closable relative to the adjustment portion 120, and the grip portion is at least partially received in an inner surface of the clamping portion 130. Of course, three or more grasping arms 151 may also be provided in each group as desired to achieve a leaflet capturing function in cooperation with the caliper arms 131.
In the delivery state, the grip is at least partially received in the inner surface of the clamp 130, i.e., the grip arms 151 are at least partially received in the inner surface of the clamp arms 131, thereby reducing the outer diameter of the valve clamp device 100 to facilitate delivery. After the engagement of the gripper arms 131 and the gripping arms 151 to capture the leaflet, the gripping arms 151 press the leaflet into the inner surface of the gripper arms 131, thereby increasing the contact area between the gripper arms 131 and the leaflet and increasing the clamping force for the leaflet.
The valve clamping device 100 further comprises a base 160 fixedly connected to the support portion 110, and each of the clamp arms 131 is rotatably connected to the base 160. Specifically, the proximal end of the base 160 is fixedly connected to the first end 111 of the supporting portion 110, and it should be noted that, for convenience of explanation, this portion is defined as the term "base", and the structure for realizing the function of the base 160 may also be the first end 111 of the supporting portion 110 itself, so that the definition of the term "base" should not form a limitation to the scope of the present application. Each of the jawarms 131 in each set are pivotally connected together at a base 160 by a pivot 132, the first end 121 of the adjustment portion 120 is axially spaced from the base 160, and each of the jawarms 131, in cooperation with one another, can be opened and closed together about the adjustment portion 120 upon actuation of the actuation portion 140.
In this embodiment, the driving part 140 includes: a driving shaft 141, a connecting seat 142 and two connecting rods 143. Wherein, one end of each connecting rod 143 is rotatably connected with the clamping part 130, and the other end is rotatably connected with the connecting seat 142; one end of the driving shaft 141 is fixedly connected to the connecting seat 142, and the other end is movably inserted into the base 160. Specifically, one end of each link 143 is rotatably connected to one of the clamp arms 131, and the other end is rotatably connected to the connecting seat 142 by a pivot 144, that is, each clamp arm 131 is rotatably connected to the connecting seat 142 of the driving shaft 141 by the link 143 on the corresponding side. The driving shaft 141 movably passes through the base 160, and when the driving shaft 141 slides in the axial direction relative to the base 160, the driving link 143 rotates and drives the clamp arm 131 to open or close around the rotational connection portion with the base 160.
Specifically, the driving portion 140 includes at least one set of connecting rods 143, and the connecting rods 143 are disposed in one-to-one correspondence with the arrangement of the clamp arms 131, for example, in fig. 10, two clamp arms 131 are used, and two connecting rods 143 are disposed in a corresponding manner. One end of the link 143 is pivotally connected to the connecting section 142 by a pivot 144 such as a pin, and the other end is pivotally connected to the corresponding jawarms 131 by a pivot 132 such as a pin, and each jawarms 131 is pivotally connected to the base 160 by a pivot 132 such as a pin. When the driving shaft 141 moves toward the first end 111 of the supporting portion 110 relative to the base 160 in the axial direction, the connecting rod 143 is moved, and the clamp arm 131 rotates around the pivot 132 to be opened relative to the base 160 under the pulling of the connecting rod 143. When the driving shaft 141 is moved in the axial direction relative to the base 160 toward the second end 115 of the supporting portion 110, the connecting rod 143 pushes the clamp arm 131 to rotate about the pivot 132 to be closed relative to the base 160. The connecting seat 142 may be shaped as any one of a hemisphere, a spherical cap, or a bullet, so that the valve clamping device 100 can be pushed in the body more easily. The driving shaft 141 and the connecting seat 142 may be an integral structure or a non-integral structure. In order to ensure the safety after implantation, the driving shaft 141 and the connecting seat 142 are made of a biocompatible material such as polyester, silicone, stainless steel, cobalt alloy, cobalt-chromium alloy, or titanium alloy, preferably stainless steel or cobalt-chromium alloy with high hardness.
Preferably, referring to fig. 10, the valve clamping device 100 further comprises a locking portion 170 provided in the base 160, the locking portion 170 limiting the relative movement of the drive shaft 141 and the base 160. In the delivery state, the locking part 170 limits the relative movement between the driving shaft 141 and the base 160, so as to ensure that the clamping part 130 is always kept in a closed state relative to the adjusting part 120 and the supporting part 110, and avoid the accidental unfolding of the clamping part 130; after the valve reaches the vicinity of the mitral valve, the driving shaft 141 is limited by the unlocking locking part 170, that is, the clamping part 130 can be driven by the driving part 140 to unfold and support the valve leaflets relative to the adjusting part 120 and the supporting part 110; after pinching the leaflet, the locking part 170 restricts the relative movement of the driving shaft 141 and the base 160 again, thereby maintaining the clamped state of the leaflet 1. Any suitable locking means may be used and will not be described further herein.
With reference to fig. 5 and 9, further, the distal end of each of the clamp arms 131 (the end of the clamp arm 131 away from the pivot connection or the free end is defined as the distal end of the clamp arm 131) is further provided with a turned-over section 137, and the turned-over section 137 is an arc surface turned over toward the outer side of the distal end of the clamp arm 131 when viewed from the front of fig. 9, and the radius of the arc surface is preferably 1mm to 2 mm. When the forceps arm 131 is closed relative to the adjusting part 120 so as to clamp the valve leaflet 1 between the forceps arm 131 and the adjusting part 120, the valve leaflet 1 is attached to the flanging section 137 of the cambered surface, the bearing area of the tail end of the forceps arm 131 to the valve leaflet 1 is increased, local stress concentration of the valve leaflet 1 at the tail end of the forceps arm 131 can be avoided, and damage to the valve leaflet caused by repeated friction between the tail end edge of the forceps arm 131 and the valve leaflet 1 along with heartbeat is effectively reduced. After the clamp arms 131 abut against the adjusting portion 120, the self-expanding body 125 of the adjusting portion 120 axially protrudes from the flanging section 137, or the second section 126 of the self-expanding body 125 is higher than the flanging section 137, so as to ensure that the length of the leaflet 1 clamped between the clamp arms 131 and the third section 128 of the self-expanding body 125 is not less than the length of the clamp arms 131.
Referring to fig. 13-17, the present invention further provides a valve clamping system, comprising the valve clamping device 100 and a delivery device 200, wherein the delivery device 200 comprises: a push sheath 210 with a certain axial length and a mandrel (not shown) movably inserted into the push sheath 210, wherein the push sheath 210 is detachably connected to the supporting portion 110, and the mandrel is detachably connected to the driving portion 140 for driving the clamping portion 130 to open and close. In this embodiment, the proximal end of the driving shaft 141 is provided with an external thread, and the spindle is connected to the driving shaft 141 through a thread, so that the spindle can control the axial movement of the driving shaft 141 outside the patient. It should be understood that only a portion of the structure of the delivery device is shown, and any other portion may be any suitable structure that is known in the art, and will not be described herein.
Specifically, the outer wall of the proximal end of the supporting portion 110 is symmetrically provided with at least one locking position 114 communicated with the lumen of the supporting portion 110, the distal end of the pushing sheath 210 is provided with a connecting member 220, the connecting member 220 includes two branches, and the end of each branch is a convex locking platform 221. In the natural state, both branches point at the central axis of the connector 220. During assembly, the connecting member 220 is inserted into the supporting portion 110, and the mandrel of the delivery device 200 is inserted into the pushing sheath 210 until the mandrel is inserted into the connecting member 220, the two branches of the connecting member 220 are lifted outwards, and the clamping platforms 221 at the ends of the branches are clamped into the two clamping positions 114 of the supporting portion 110, so as to connect the supporting portion 110 and the connecting member 220, i.e., connect the valve clamping device 100 and the delivery device 200. When the mandrel is withdrawn from the connecting member 220 and the pushing sheath 210, the two branches return to the inward natural state, and the locking platform 221 is disengaged from the locking position 114 of the supporting portion 110, so that the valve clamping device 100 and the delivery device 200 are disconnected. The connecting member 220 may be made of a material having a certain hardness and elasticity, such as nickel titanium. The propelling sheath 210 may be a multi-layer composite tube. The mandrel can be made of stainless steel materials or nickel-titanium alloy materials.
With reference to fig. 11 and 13, a through hole is formed in the support portion 110 as a through passage 113 of the driving shaft 141, and the driving shaft 141 is axially slidably inserted into the through passage 113 of the support portion 110 and fixedly connected to the connecting seat 142. After the clamping portion 130 and the grasping portion 150 are engaged to capture the valve leaflet, the mandrel drives the driving shaft 141 to move axially, so as to drive the clamp arms 131 to completely close relative to the supporting portion 110, so that the valve clamping device 100 is in a closed state and falls below the valve. The mandrel can then be disconnected from the drive shaft 141, withdrawn from the connection element 220, and the locking platform 221 separated from the locking position 114 of the support 110, thereby releasing the valve clamping device 100 and the delivery device 200.
Referring to fig. 14-18, the following discussion of the use of the valve clamping device 100 of the present application is provided in the context of a transcatheter approach to transeptal-atrial antegrade approach and repair of a mitral valve:
the first step is as follows: as shown in fig. 14, the drive shaft 141 and the valve clamping device 100 connected thereto are advanced from the left atrium 2, through the mitral valve 1 to the left ventricle 3, by means of a guiding device (not shown) such as an adjustable curved sheath;
the second step is that: adjusting the valve clamping device 100 to approximate the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1;
the third step: as shown in fig. 15, the locking part 170 in the base 160 is unlocked, the mandrel and the driving shaft 141 are pushed to the far end, the clamp arm 131 is driven to open relative to the supporting part 110, the direction of the clamp arm 131 is adjusted, and at this time, the relative positions of the clamp arm 131 and the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 can be observed through an X-ray device, so that the clamp arm 131 is perpendicular to the coaptation line of the mitral valve 1;
the fourth step: as shown in fig. 16, the entire valve clamping device 100 is withdrawn proximally, causing the gripper arms 131 to hold the leaflet 1 on the left ventricle 3 side, releasing the gripping arms 151 on both sides, the gripping arm 151 on each side pressing the leaflet 1 on the atrial side and engaging the gripper arms 131 on that side to capture the leaflet 1;
the fifth step: as shown in fig. 17, when the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are captured between the pair of forceps arms 131 and the grasping arm 151, respectively, the mandrel and the drive shaft 141 are pulled proximally, thereby driving the forceps arms 131 to close;
and a sixth step: the threaded connection between the mandrel and the driving shaft 141 is released, the mandrel is withdrawn, the two branches of the connecting piece 220 return to the state of closing towards the central shaft, the clamping table 221 is separated from the clamping position 114 of the supporting part 110, the connection between the valve clamping device 100 and the delivery device 200 is released, then the delivery device 200 is withdrawn out of the body, the implantation state shown in fig. 18 is obtained, at the moment, the valve clamping device 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 towards each other, a diploidized mitral valve is obtained, and the edge-to-edge repair of the mitral valve is completed.
After the valve clamping device 100 is implanted, the adjusting part 120 with elasticity is filled between the anterior leaflet 1a and the posterior leaflet 1b of the clamped mitral valve 1 and provides radial supporting force for the valve leaflet 1, and the adjusting part 120 has a buffer effect on the pulsating valve leaflet 1, so that the valve clamping device 100 can adjust the pulling degree of the valve leaflet 1 to avoid damaging the valve leaflet 1.
Example two
Referring to fig. 19 to 21, compared with the valve clamping device 100 of the first embodiment, the structures of the supporting portion 110, the clamping portion 130, the driving portion 140, the grasping portion 151, etc. of the valve clamping device 100 'of the second embodiment of the present invention remain unchanged, and are not repeated herein, but the structure of the adjusting portion 120' is changed.
Specifically, in this second embodiment, the adjusting portion 120 ' adds a bending section 129 to the self-expanding body compared to the adjusting portion 120 of the first embodiment, the bending section 129 is connected between the second end 123 of the adjusting portion 120 ' and the first section 124 of the self-expanding body, and preferably, the cross-sectional shape of the bending section 129 is an arc shape recessed toward the first end 121 of the adjusting portion 120 '. The first section 124 and the bent section 129 still form a recessed area 122 ' opposite to the second section 126, and the end of the recessed area 122 ' (the end of the bent section 129 close to the second end 123 of the adjustment portion 120 ' is defined as the end of the recessed area 122 ') extends toward the second end 115 of the support portion 110 to the second end 123 of the adjustment portion 120 '.
When the adjusting part 120 'is manufactured, firstly, a woven net tube with two open ends is prepared, the woven net tube is sleeved on a lining rod, and then a forming sleeve is sleeved outside the upper end of the woven net tube to form a second end 123 of the adjusting part 120'; then, the lower end of the mesh tube is pushed upward (the direction of the second end 123 of the adjusting part 120 'in fig. 20 is the upper direction, and the direction of the first end 121 is the lower direction), and the mesh tube is heat-set by means of the forming mold, so as to form the adjusting part 120' with the overall shape still approximately in the shape of an inverted cone as shown in fig. 20 and 21, and the lower end of the mesh tube forms the first end 121 with the opening of the adjusting part 120 'below the upper end of the mesh tube, and the forming sleeve and the forming mold are removed, so as to obtain the adjusting part 120'.
When the adjusting portion 120 ' is assembled with the supporting portion 110, a portion between the second end 115 and the first end 111 of the supporting portion 110 is inserted into the hollow accommodating cavity of the adjusting portion 120, the second end 123 of the adjusting portion 120 ' is fixedly connected with the supporting portion 110 through the fixing member 80, the fixing member 80 may be a steel sleeve, the second end 123 of the adjusting portion 120 is inserted between the steel sleeve and the outer surface of the supporting portion 110, and the second end 123 of the adjusting portion 120 ' is fixedly connected with the supporting portion 110 by laser welding the steel sleeve and the supporting portion 110. In this embodiment, the second end 123 of the adjusting portion 120 'is inserted into the fixing member 80 toward the second end 115 of the supporting portion 110, that is, the second end 123 of the adjusting portion 120' is inserted into the fixing member 80 from bottom to top.
In the closed state of the valve clamping device 100', the bending section 129 resists inward deformation of the first section 124, and this resistance is superimposed on the corresponding portion of the third section 128 connected to the second section 126, further improving the resilient fit of the leaflets to the accommodation 120, so that the leaflets can sufficiently fit to the accommodation 120. Accordingly, the adjustment portion 120 can provide a greater radial supporting force to the leaflet, thereby further improving the clamping force to firmly clamp the leaflet.
EXAMPLE III
As shown in fig. 22, in the valve clamping device according to the third embodiment of the present invention, compared with the valve clamping device according to the first embodiment, the structures of the supporting portion, the clamping portion, the driving portion, the grasping portion, and the like are kept unchanged, and are not described herein, but the structure of the self-expanding body 125' of the adjusting portion is changed.
The self-expanding body 125' in this third embodiment includes an adapter section 127 in addition to the first section 124, the second section 126, and the third section 128. The adapter section 127 is connected between the second section 126 and the third section 128, and extends radially outward compared to the third section 128 (radially inward toward the central axis of the support 110, and radially outward away from the central axis of the support 110). The adapting section 127 is arranged corresponding to the flanging section 137 at the tail end of the forceps arm, and the shape of one side of the adapting section facing the flanging section 137 is complementary with the arc surface presented by the flanging section 137.
When the forceps arms are closed relative to the adjusting part 120 so as to clamp the valve leaflets between the forceps arms and the adjusting part 120, the adapting section 127 axially protrudes out of the flanging section 137, or the adapting section 127 is higher than the flanging section 137, and partial valve leaflets are also clamped between the adapting section 127 and the flanging section 137, so that the valve leaflets are attached to the cambered surface of the flanging section 137, the bearing area of the valve leaflets at the tail ends of the forceps arms is increased, the valve leaflets can be prevented from being locally stressed and concentrated at the tail ends of the forceps arms, and the damage to the valve leaflets caused by repeated friction between the tail ends of the forceps arms and the valve leaflets along with the heartbeat is effectively reduced; on the other hand, the valve leaflet also forms the laminating with curved adaptation section 127, further increases the laminating area of valve leaflet and regulating part, promotes the elasticity laminating nature of valve leaflet and regulating part, makes valve leaflet and regulating part laminating more abundant, and correspondingly, the regulating part can provide more sufficient radial holding power for valve leaflet, and then further improves clamping force and firmly grasps valve leaflet.
Example four
Referring to fig. 23 to 25, compared with the valve clamping device 100 of the first embodiment, the structure of the adjusting portion 120 of the valve clamping device 400 of the fourth embodiment of the present invention remains the same, and is not described herein again, but the structures of the supporting portion 410, the clamping portion 430, and the driving portion 440 are changed.
Specifically, in this fourth embodiment, the clamping portion 430 includes at least two jawarms, and may generally include at least one set of jawarms, each set of jawarms including two jawarms symmetrically disposed about the adjustment portion 120, and the clamping portion 40 in this embodiment includes one set of jawarms. At least one anchor 431 is provided on each of the arms, and when the arms are closed relative to the adjustment portion 120, the anchor 431 can be pressed against the leaflets to be embedded in the mesh of the adjustment portion 120 of the mesh structure, so that the leaflets are held by the anchor 431 upon the clamping of the leaflets by the adjustment portion 120 and the arms.
The driving part 440 includes a driving shaft 410, an automatic closing unit 445, and at least two links 443. One end of each connecting rod 443 is rotatably connected with a corresponding tong arm, and the other end of each connecting rod is directly rotatably connected with the driving shaft 441 through a pin shaft; the driving shaft 441 is movably inserted into the supporting portion 410; the automatic closing unit 445 connects the both forceps arms for making the nip portion 430 abut against the regulating portion 120 in a natural state.
The base 416 and the first end 411 of the supporting portion 410 are integrally formed, and the two clamp arms are rotatably connected to the base 416. The supporting portion 410 is provided with an axial slot 419 for the pin shaft to pass through. When the driving shaft 441 drives the pin shaft to move toward the first end 411 of the supporting portion 410 in the axial groove 419, the driving link 443 overcomes the obstruction of the automatic closing unit 445 to open the two forceps arms relatively.
In this embodiment, the automatic closing unit 445 is a U-shaped elastic piece, two ends of the U-shaped elastic piece are respectively connected to a pair of clamp arms, and when the driving shaft 441 does not apply a pushing force to the pin shaft, the U-shaped elastic piece resets itself to drive the two clamp arms to close and abut against the adjusting portion 120. It is understood that in other embodiments, the automatic closing unit 445 may also be an elastic member such as a V-shaped elastic sheet or a torsion spring.
EXAMPLE five
Referring to fig. 26, in comparison with the valve clamping device 400 of the fourth embodiment, the valve clamping device 400 'of the fifth embodiment of the present invention replaces the adjusting portion 120 of the fourth embodiment with the adjusting portion 120' of the second embodiment, and other structures remain unchanged, which is not described herein again.
Example six
Referring to fig. 27 and 28, compared with the valve clamping device 100 of the first embodiment, the structure of the adjusting portion 120 of the valve clamping device 500 of the sixth embodiment of the present invention remains the same, and is not described herein again, but the structures of the clamping portion 530 and the driving portion 540 are changed.
In this embodiment, the base 516 and the first end 511 of the supporting portion 510 are an integral structure, and one end of the clamp arm of the clamping portion 530 is connected to the base 516. The driving part 540 comprises a driving shaft 541 and at least two elastic driving arms 545, one end of each elastic driving arm 545 is fixedly connected with one end of the driving shaft 541, the other end of each elastic driving arm 545 is connected with the other end of each clamp arm, and the other end of each driving shaft 545 movably penetrates through the supporting part 510; the elastic driving arm 545 is used for enabling the clamping part 530 to abut against the adjusting part 120 in a natural state; one end of the gripping arm 551 is connected to the arms of the clamp 530, and in the deployed state of the valve clamping device 500, the gripping arm 551 is controlled by a pull wire (not shown) in the delivery device to open relative to the arms to allow the leaflets to enter between the gripping arm 551 and the arms.
In this embodiment, the two clamp arms and the two elastic driving arms 545 are integrated, i.e. the two clamp arms themselves are also elastic. When the driving shaft 541 moves towards the first end 511 of the supporting portion 510, the two forceps arms are opened relatively against the resistance of the two elastic driving arms 545; when the driving shaft 541 does not apply a pushing force to the elastic driving arms 545, the two elastic driving arms 545 restore to drive the two clamp arms to close and abut against the adjusting part 120. It should be noted that when the driving shaft 541 is continuously pushed toward the first end 511 of the supporting portion 510, the joint between the forceps arm and the driving arm 545 can gradually approach toward the driving shaft 541 until the forceps arm and the driving arm 545 are substantially aligned, and the pulling wire is used to control the grasping arm 551 to fit the adjusting portion 120, so that the flattened valve clamping device 500 can be more easily retracted into the sheath.
In addition, the valve coaptation device 500 of this embodiment can achieve dynamic balancing of the leaflet coaptation state: when the valve leaflet applies a large pulling force to the valve clamping device 500, the elastic driving arm 545 and the forceps arms can adjust the clamping angle within a certain range without being separated from the valve leaflet, so that the valve leaflet is prevented from being damaged by the large pulling force.
EXAMPLE seven
Referring to fig. 29, in comparison with the valve clamping device 500 of the sixth embodiment, the adjusting portion 120 'of the sixth embodiment is replaced with the adjusting portion 120' of the second embodiment, and other structures are not changed, which is not described herein again.
Example eight
Referring to fig. 30 and 31, compared with the valve clamping device 100 of the first embodiment, only the structure of the supporting portion 610 is changed, and other structures are not changed, which is not described herein again.
In this embodiment, the connection part of the supporting part 610 and the delivery device 200 'is not disposed at the second end as in the first embodiment, but a connection part 670 is disposed on the base 660 at the first end of the supporting part 610, and the connection part 670 is detachably connected with the pushing sheath of the delivery device 200'. Specifically, the connection portion 670 and the pushing sheath of the conveying device 200 ' are respectively provided with splicing structures with complementary shapes, the pushing sheath is movably sleeved with an outer sheath 70, when the outer sheath 70 surrounds the splicing structures with complementary shapes, the support portion 610 and the conveying device 200 ' are kept connected, and when the outer sheath 70 is retracted and the splicing structures with complementary shapes are exposed, the support portion 610 and the conveying device 200 ' can be disconnected.
As shown in fig. 31, the delivery device 200' of this embodiment may be used to perform edge-to-edge repair of the mitral valve by transapical delivery of the valve clamping device 600 into the heart. It should be noted that the outer sheath 70 remains wrapped around the complementary shaped splice structure until the forceps arms are fully closed; after the two clamp arms are closed, the connection between the valve clamping device 600 and the delivery device 200' can be released by first disengaging the threaded connection between the mandrel and the drive shaft and withdrawing the mandrel, and then withdrawing the outer sheath 70 to expose the splice structure.
It will be appreciated that the present invention provides a valve coaptation system including any of the valve coaptation devices described above and a delivery device capable of delivering the valve coaptation device from outside the body to the vicinity of the mitral valve and coapting the leaflets.
It can be understood that the valve clamping device and the valve clamping system provided by the invention can also perform edge-to-edge repair on the tricuspid valve by only selecting a corresponding intervention path (such as femoral vein-inferior vena cava-right atrium-right ventricle) and implanting a suitable number of valve clamping devices according to the number of valve leaflets to be repaired (such as implanting three valve clamping devices to respectively clamp the anterior leaflet and the posterior leaflet, the posterior leaflet and the septal leaflet, and the septal leaflet and the anterior leaflet of the tricuspid valve).
The foregoing are merely exemplary embodiments of the present invention to enable those skilled in the art to understand or practice the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (19)

1. A fully conformable valve clamping device, comprising:
a support portion having an axial length and including first and second ends disposed in opposition;
an adjustment portion comprising first and second oppositely disposed ends and a self-expanding body located between the first and second ends; the first end of the adjusting part is movably sleeved on the outer side of the supporting part, the second end of the adjusting part is sleeved on the outer side of the supporting part and is fixedly connected with the supporting part, and the first end of the adjusting part is positioned between the first end of the supporting part and the second end of the adjusting part;
the clamping part is arranged on the outer side of the supporting part and can be unfolded or closed relative to the adjusting part.
2. The fully conformable valve clamping device of claim 1, wherein the self-expanding body in a natural state has a diameter that gradually increases from the first end of the adjustment portion to the second end of the adjustment portion.
3. The fully conformable valve clamping device of claim 2, wherein said self-expanding body is a mesh structure made of a shape memory material.
4. The substantially conformable valve clipping device of claim 3, wherein the mesh structure is externally and/or internally covered with a biocompatible film.
5. The fully conformable valve clamping device of claim 1, wherein the self-expanding body has a recessed region connected to the second end of the adjustment portion, the distal end of the recessed region extending toward the first end of the support portion to the second end of the adjustment portion or the distal end of the recessed region extending toward the second end of the support portion to the second end of the adjustment portion.
6. The fully conformable valve clamping device of claim 5, further comprising a securing member, wherein the second end of the adjustment portion is threaded and secured in the securing member to be fixedly connected to the support portion by the securing member.
7. The fully conformable valve clamping device of claim 1, wherein the self-expanding body comprises a first section, a second section, and a third section connected in series;
the first section extends from the second end of the adjusting part to the second end of the supporting part, and the first section surrounds the outer side of the second end of the supporting part; the second section continues radially outward from the first section; the third section extends from the second section toward the first end of the support portion while radially inward to terminate at the first end of the adjustment portion.
8. The fully conformable valve clamping device of claim 7, wherein said self-expanding body further comprises a bent section connected between said second end of said adjustment portion and said first section.
9. The fully conformable valve clamping device of claim 7, wherein the second section of the self-expanding body has a radial dimension in the range of 4mm to 15mm and the first end of the adjustment portion has a radial dimension in the range of 1mm to 5 mm.
10. The fully conformable valve clamping device of any one of claims 1 to 9, further comprising an actuating portion, said clamping portion comprising at least two clamping arms, said at least two clamping arms being symmetrically disposed with respect to said adjustment portion, said actuating portion being connected to each of said clamping arms respectively to actuate each of said clamping arms toward or away from said adjustment portion.
11. The fully conformable valve clamping device of claim 10, wherein said first end of said support portion defines a base, each of said clamping arms being pivotally connected to said base, said first end of said support portion being axially spaced from said first end of said adjustment portion.
12. The fully conformable valve clamping device of claim 11, wherein the actuation portion comprises: the connecting device comprises a driving shaft, a connecting seat and at least two connecting rods; one end of each connecting rod is rotatably connected with one forceps arm, and the other end of each connecting rod is rotatably connected with the connecting seat; one end of the driving shaft is connected with the connecting seat, and the other end of the driving shaft is movably arranged in the base in a penetrating mode.
13. The fully conformable valve coaptation device of claim 12, further comprising a locking portion disposed in the base, the locking portion restricting relative movement of the drive shaft and the base.
14. The fully conformable valve clamping device of claim 11, wherein the actuation portion comprises: a drive shaft, an automatic closing unit, and at least two links; the driving shaft is movably arranged in the supporting part in a penetrating manner, one end of each connecting rod is rotatably connected with one forceps arm, and the other end of each connecting rod is rotatably connected with the driving shaft; the automatic closing unit is connected with the clamp arm and is used for enabling the clamp arm to abut against the adjusting part in a natural state.
15. The fully conformable valve clamping device of claim 11, wherein the actuating portion comprises a drive shaft and at least two elastic actuating arms, one end of the drive shaft is movably mounted in the support portion, one end of each elastic actuating arm is fixedly connected to the other end of the drive shaft, and the other end of each elastic actuating arm is connected to one of the clamp arms; the elastic driving arm is used for enabling the clamp arm to abut against the adjusting part in a natural state.
16. The fully conformable valve clamping device of claim 10, wherein the distal ends of said clamping arms are provided with a crimping section that is a curved surface that is crimped towards the outside of the distal ends of said clamping arms, said self-expanding body axially protruding beyond said crimping section after said clamping arms are crimped to said adjustment portion.
17. The fully conformable valve clamping device of claim 16, wherein the self-expanding body is provided with an adapter section at the cuff section, the adapter section having a shape complementary to the curved surface on a side facing the cuff section.
18. The fully conformable valve coaptation device of any of claims 1-9, further comprising a grip portion disposed between the coaptation portion and the adjustment portion and deployable or closable relative to the support portion.
19. A valve clamping system comprising the substantially conformable valve clamping device of any one of claims 1-18 and a delivery device, the delivery device comprising: the propelling movement sheath pipe that has certain axial length and activity wear to adorn in the dabber in the propelling movement sheath pipe, the propelling movement sheath pipe with can dismantle the connection between the supporting part, the dabber is used for the drive the expansion and the closure of clamping portion.
CN202110057563.4A 2020-03-18 2021-01-15 Valve clamping device and valve clamping system with full fitting Pending CN114762635A (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN202110057563.4A CN114762635A (en) 2021-01-15 2021-01-15 Valve clamping device and valve clamping system with full fitting
EP21770911.2A EP4122426A4 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system
US17/906,641 US20230157819A1 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system
BR112022018791A BR112022018791A2 (en) 2020-03-18 2021-03-18 VALVE FIXING DEVICE AND VALVE FIXING SYSTEM
PCT/CN2021/081606 WO2021185324A1 (en) 2020-03-18 2021-03-18 Valve clamping device and valve clamping system

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202110057563.4A CN114762635A (en) 2021-01-15 2021-01-15 Valve clamping device and valve clamping system with full fitting

Publications (1)

Publication Number Publication Date
CN114762635A true CN114762635A (en) 2022-07-19

Family

ID=82364745

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202110057563.4A Pending CN114762635A (en) 2020-03-18 2021-01-15 Valve clamping device and valve clamping system with full fitting

Country Status (1)

Country Link
CN (1) CN114762635A (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116269933A (en) * 2022-12-30 2023-06-23 杭州端佑医疗科技有限公司 Valve repair device and system
WO2024093232A1 (en) * 2022-11-03 2024-05-10 杭州德晋医疗科技有限公司 Stable-fitting valve clip device and valve clip system

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024093232A1 (en) * 2022-11-03 2024-05-10 杭州德晋医疗科技有限公司 Stable-fitting valve clip device and valve clip system
CN116269933A (en) * 2022-12-30 2023-06-23 杭州端佑医疗科技有限公司 Valve repair device and system
CN116269933B (en) * 2022-12-30 2024-03-15 杭州端佑医疗科技有限公司 Valve repair device and system

Similar Documents

Publication Publication Date Title
CN212490263U (en) Valve clamping device with adjustable supporting force and valve clamping system
CN215130898U (en) Valve clamping device and valve clamping system with full fitting
US20220142780A1 (en) Adjustable valve clip and valve clamping system
US11712337B2 (en) Delivery systems and methods of implantation for prosthetic heart valves
CN111904660A (en) Valve clamping device and valve clamping system
CN211325891U (en) Adjustable valve clamping device and valve clamping system
WO2015142648A1 (en) Mitral valve replacement toggle cell securement
JP2022534021A (en) Delivery system for heart valve device
CN112386368A (en) Adjustable valve clamping device and valve clamping system
CN109350308B (en) Step-by-step clamping type valve prosthesis and conveying system thereof
CN112206017A (en) Valve clamping device easy to clamp and valve clamping system
CN114569291B (en) Atrioventricular valve clamping device and atrioventricular valve clamping system
CN114762635A (en) Valve clamping device and valve clamping system with full fitting
WO2020114296A1 (en) Transcatheter prosthetic valve replacement system
US20240008983A1 (en) Valve clamping device with adjustable bearing force and valve clamping system
CN215651790U (en) Valve clamping device with plugging function and valve clamping system
CN117045398A (en) Valve repair device
US11957585B2 (en) Fixing device for clamping tissue
CN215130900U (en) Self-adaptive valve clamping device and valve clamping system
US20230157819A1 (en) Valve clamping device and valve clamping system
CN215349755U (en) Valve clamping device for preventing valve leaflet from being damaged and valve clamping system
CN114073602A (en) Valve clamping device with adjustable supporting force and valve clamping system
CN214104757U (en) Valve clamping device and valve clamping system
CN211834508U (en) Valve clamping device easy to clamp and valve clamping system
CN115105252A (en) Valve clamping device with plugging function and valve clamping system

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination