CN117357307A - Valve repair device and valve repair system - Google Patents
Valve repair device and valve repair system Download PDFInfo
- Publication number
- CN117357307A CN117357307A CN202210778261.0A CN202210778261A CN117357307A CN 117357307 A CN117357307 A CN 117357307A CN 202210778261 A CN202210778261 A CN 202210778261A CN 117357307 A CN117357307 A CN 117357307A
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- Prior art keywords
- gripping
- valve repair
- state
- repair device
- clamping
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- 230000008439 repair process Effects 0.000 title claims abstract description 121
- 238000003825 pressing Methods 0.000 claims abstract description 13
- 239000007943 implant Substances 0.000 claims description 30
- 230000005540 biological transmission Effects 0.000 claims description 5
- 238000000034 method Methods 0.000 abstract description 18
- 230000008569 process Effects 0.000 abstract description 14
- 210000004204 blood vessel Anatomy 0.000 abstract description 8
- 210000001519 tissue Anatomy 0.000 description 17
- 210000004115 mitral valve Anatomy 0.000 description 16
- 238000002513 implantation Methods 0.000 description 12
- 239000000463 material Substances 0.000 description 12
- 210000000591 tricuspid valve Anatomy 0.000 description 9
- 239000008280 blood Substances 0.000 description 7
- 210000004369 blood Anatomy 0.000 description 7
- 238000002788 crimping Methods 0.000 description 5
- 210000002837 heart atrium Anatomy 0.000 description 5
- 229910001000 nickel titanium Inorganic materials 0.000 description 4
- 206010067171 Regurgitation Diseases 0.000 description 3
- 210000003157 atrial septum Anatomy 0.000 description 3
- 239000013013 elastic material Substances 0.000 description 3
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- 238000013459 approach Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 208000018578 heart valve disease Diseases 0.000 description 2
- 230000003993 interaction Effects 0.000 description 2
- 210000005246 left atrium Anatomy 0.000 description 2
- 210000005240 left ventricle Anatomy 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 210000005245 right atrium Anatomy 0.000 description 2
- 210000005241 right ventricle Anatomy 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 229910000684 Cobalt-chrome Inorganic materials 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
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- 210000001765 aortic valve Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
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- 230000008859 change Effects 0.000 description 1
- 210000003698 chordae tendineae Anatomy 0.000 description 1
- 239000010952 cobalt-chrome Substances 0.000 description 1
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
Abstract
The invention provides a valve repair device and a valve repair system, wherein the valve repair system comprises a valve repair device and a delivery device; the valve repair device includes a drive component and a plurality of gripping components; the clamping component is used for clamping target tissues; the driving component is used for driving the clamping component to rotate, and the clamping component respectively has a clamping state, a grabbing state and a pressing state when rotating to different angles, wherein the rotating angle of the clamping component in the pressing state relative to the preset direction is larger than the rotating angle of the clamping component in the clamping state relative to the preset direction, and is also larger than the rotating angle of the clamping component in the grabbing state relative to the preset direction. By the arrangement, the valve repair device has smaller radial dimension after being pressed and held, so that damage to blood vessels or hearts in the access process of the valve repair device can be avoided, and the safety and reliability in the operation process are improved.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a valve repair device and a valve repair system.
Background
With the development of socioeconomic performance and the aggravation of aging population, senile valvular diseases and valvular lesions caused by coronary heart disease and myocardial infarction are more and more common. Studies have shown that over 13.3% of the elderly over 75 years old suffer from varying degrees of heart valve disease. Among them, diseases of the mitral valve, tricuspid valve or aortic valve are clinically common heart valve diseases.
The heart of a human body is divided into four chambers, namely a left atrium, a left ventricle, a right atrium and a right ventricle, and a thin film separating an atrium from the ventricle is called an atrioventricular valve. The atrioventricular valve consists of leaflets, annuli, chordae tendineae and papillary muscles, which can open or close and act as one-way valves to allow blood to flow only from the atrium to the corresponding ventricle. Wherein the atrioventricular valve separating the left atrium from the left ventricle is the mitral valve and the atrioventricular valve separating the right atrium from the right ventricle is the tricuspid valve. During ventricular filling (diastole), the mitral and tricuspid valves open to allow blood to pass from the atria into the corresponding ventricles. During ventricular systole (evacuation), the mitral and tricuspid valves close to prevent blood from the atria from entering the respective ventricles. In ventricular systole, if the mitral or tricuspid valve is not closed, blood in the ventricle can flow back into the corresponding atrium (i.e., regurgitation of blood) through the gap between the mitral or tricuspid valve, which often results in heart failure, reduced blood flow, reduced blood pressure, and in severe cases permanent disability or death of the patient.
Currently, implantation of valve repair devices at the atrioventricular valve site is one of the common means of treating atrioventricular valve insufficiency. The valve repair system generally includes a valve repair device, which is an implantable prosthesis, a delivery system, and a handle, which, after implantation, eliminates the leaflet closed gap by gripping the leaflet to reduce regurgitation of blood. Specifically, taking an implanted valve repair device of the mitral valve as an example, the valve repair device is first held and loaded in a delivery system, then the delivery system is passed through the atrial septum to the position of the mitral valve, and then the implant is extended from the delivery system and the leaflets are gripped.
The radial dimension of the implant after being pressed and held is larger, so that the radial dimension of the implant after being conveyed by the conveying system is also larger, the damage to blood vessels or the atrial septum can be caused in the conveying system conveying process, and the atrial septum can be torn in severe cases. While the radial dimension of the valve repair device after crimping can be reduced if the size of the parts in the valve repair device is reduced, the smaller-sized valve repair device may not completely avoid regurgitation of the atrioventricular valve, resulting in failure of the leaflet repair procedure.
Disclosure of Invention
The invention aims to provide a valve repair device and a valve repair system, wherein the device can have smaller radial dimension after being pressed and held, so that the valve repair device can be prevented from damaging a blood vessel or a heart in the process of access, and the safety and the reliability in the process of operation are further improved.
In order to achieve the above object, the present invention provides a valve repair device, including a driving part and a plurality of gripping parts for gripping a target tissue, and connected to the driving part; the driving component is used for driving the clamping component to rotate, and the clamping component respectively has a clamping state, a grabbing state and a pressing and holding state when rotating to different angles, and can be switched among the clamping state, the grabbing state and the pressing and holding state;
the rotation angle of the gripping member in the press-holding state with respect to a predetermined direction, which is a direction in which the distal end of the driving member is directed to the proximal end, is larger than the rotation angle of the gripping member in the gripping state with respect to the predetermined direction, and is also larger than the rotation angle of the gripping member in the gripping state with respect to the predetermined direction.
Optionally, as the rotation angle of the gripping member with respect to the predetermined direction increases, the valve repair device reaches the gripping state, the grabbing state, and the press-holding state in this order.
Optionally, the rotation angle of the gripping member with respect to the predetermined direction is 0 ° to 180 °.
Optionally, when the rotation angle of the gripping member with respect to the predetermined direction is 120 ° to 180 °, the gripping member is in the press-holding state.
Optionally, the driving component comprises an implant connecting piece and a driving rod, and the driving rod is movably arranged in the implant connecting piece in a penetrating way and is connected with the clamping component; the drive rod is configured to move axially of the implant connector to drive rotation of the gripping member.
Optionally, the valve repair device further includes a driving arm, and each of the gripping members is configured with one driving arm, one end of each driving arm is rotatably connected to the implant connecting member, and the other end is rotatably connected to a corresponding one of the gripping members.
Optionally, the gripping component includes a gripping arm and a gripping member, the gripping member and the gripping arm being configured to cooperate with each other to grip the target tissue;
the clamping arms in each clamping component are respectively connected with the driving rod and a corresponding transmission arm in a rotating way; the gripping members in each of the gripping members are connected to a corresponding one of the gripping arms.
Optionally, the valve repair device further comprises a fixing piece, wherein the fixing piece is arranged at the distal end of the driving rod, and each clamping arm is rotationally connected with the fixing piece;
and grooves are formed in each driving arm and are used for avoiding the fixing piece and part of the clamping arms, so that the clamping part can rotate to 180 degrees.
Optionally, each of the gripping members further includes a support member, wherein the support member in each of the gripping members is connected to a corresponding one of the gripping arms, and the support member is configured to support the target tissue and to increase an area of the target tissue gripped.
Optionally, the gripping member has elasticity; the grasping member is capable of being elastically deformed when the grasping member is in the press-held state to reduce the dimension of the grasping member in the radial direction of the driving rod,
and/or the support has elasticity; the support members are capable of being elastically deformed when the gripping member is in the press-held state to reduce the size of each of the support members in the radial direction of the drive rod.
Optionally, observing with the gripping member in the gripping state; the support member is an arcuate structure protruding toward the proximal end of the drive rod and/or the grasping member is an arcuate structure protruding toward the distal end of the drive rod.
To achieve the above object, the present invention also provides a valve repair system comprising a delivery device detachably connected to the valve repair device for delivering the valve repair device to a predetermined location, and any one of the valve repair devices.
Optionally, the gripping member comprises a gripping member, and the valve repair system further comprises a plurality of control wires; each of the grasping elements is configured to be connected to a corresponding one of the control wires, each of the control wires being capable of being pulled so that the grasping element grasps the target tissue.
In the valve repair device and the valve repair system provided by the invention, the driving part in the valve repair device can drive the clamping part to rotate, so that the clamping part can respectively have a clamping state, a grabbing state and a pressing state when rotating to different angles, and can also be switched among the clamping state, the grabbing state and the pressing state, the rotating angle of the clamping part in the pressing state relative to the preset direction is larger than that of the clamping part in the clamping state, and is also larger than that of the clamping part in the grabbing state relative to the preset direction, after the valve repair device is configured in this way, the damage to blood vessels or hearts in the access process of the valve repair device can be reduced, the reflux of atrioventricular valves can be effectively avoided, the success rate of a patient operation can be further improved, and the safety and reliability in the operation process can be improved.
Drawings
FIG. 1 is a schematic front view of a valve repair device and a delivery device in a crimped state according to a preferred embodiment of the present invention, wherein the valve repair device and the delivery device are in a connected state;
FIG. 2 is a schematic perspective view of a valve repair device and a delivery device in a crimped state according to a preferred embodiment of the present invention, wherein the valve repair device and the delivery device are in a connected state;
FIG. 3 is a schematic front view of a valve repair device and a delivery device in a grasped state in accordance with a preferred embodiment of the present invention, wherein the valve repair device and the delivery device are in a connected state;
FIG. 4 is a schematic perspective view of a valve repair device and a delivery device in a grasped state in accordance with a preferred embodiment of the present invention, wherein the valve repair device and the delivery device are in a connected state;
FIG. 5 is a schematic front view of a valve repair device and delivery device in a clamped state in accordance with a preferred embodiment of the present invention, wherein the valve repair device and delivery device are in a partially connected state;
FIG. 6 is a schematic front view of a valve repair device and delivery device in a crimped state in accordance with a preferred embodiment of the present invention, wherein the valve repair device and delivery device are in a detached state;
fig. 7 is a schematic perspective view of a valve repair device and a delivery device in a clamped state in accordance with a preferred embodiment of the present invention, wherein the valve repair device and the delivery device are in a separated state.
Reference numerals are described as follows:
a valve repair device 1; an implant connector 11; a drive lever 12; a gripping member 13; a clamp arm 131; a grasping member 132; a support 133; a lumen 1331; a transmission arm 14; a groove 141; a fixing member 15; a delivery device 2; and controlling the wire 3.
Detailed Description
The invention is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.
The terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the invention.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and include, for example, either fixedly attached, detachably attached, or integrally formed; may be mechanically connected, may be electrically connected or may be in communication with each other; either directly, or through an intermediary, may be internal to the two elements or in an interactive relationship with the two elements, unless explicitly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. In the description of the present invention, "plurality" means at least two, for example, two or three or more, etc.
As used in this specification, "distal" generally refers to the end of the valve repair device that is distal from the operator; the term "proximal" as opposed to "distal" generally refers to the end of the valve repair device that is proximal to the operator; the term "axial" refers to the direction along the axis of the drive rod; the term "circumferential" refers to the circumferential direction of the axis of the drive rod; the term "radial" refers to the diametrical direction of a cross-section of the drive rod perpendicular to the axis.
The invention will now be described in detail with reference to the drawings and a preferred embodiment. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.
As shown in fig. 1 to 3, a preferred embodiment of the present invention provides a valve repairing device 1, which includes a driving part and a plurality of gripping parts 13, wherein the gripping parts 13 are used for gripping a target tissue, and are connected with the driving part, the driving part is used for driving the gripping parts 13 to rotate, the gripping parts 13 respectively have a gripping state, a grabbing state and a pressing state when rotating to different angles, and can be switched among the gripping state, the grabbing state and the pressing state, the rotation angle θ of the gripping parts 13 in the pressing state relative to a preset direction a is larger than the rotation angle θ of the gripping parts 13 in the gripping state relative to the preset direction a, and is also larger than the rotation angle θ of the gripping parts 13 in the grabbing state relative to the preset direction a, and the preset direction a is the direction that the distal end of the driving part points to the proximal direction. Further, as the rotation angle of the gripping member 13 with respect to the predetermined direction a increases, the valve repair device 1 reaches the gripping state, the grasping state, and the crimping state in this order.
It is understood that the distal end of the drive member pointing in a proximal direction means that the distal end of the drive member in the axial direction points in a proximal direction after the valve repair device 1 has been delivered to a predetermined position. In the present embodiment, both ends of the gripping member 13 include a fixed end (not numbered) connected to the driving member and a moving end (not numbered) rotated around the driving member, and the rotation angle θ refers to an angle between a direction in which the fixed end of the gripping member 13 points to the moving end and a predetermined direction a.
Referring to fig. 3, in the present embodiment, the driving part includes an implant connector 11 and a driving rod 12, and a plurality of the gripping parts 13 are sequentially disposed in a circumferential direction around an axial direction of the implant connector 11. The driving rod 12 is movably arranged in the implant connecting piece 11 in a penetrating way and is connected with the clamping component 13. The drive rod 12 is adapted to move in the axial direction of the implant connector 11 to drive the gripping member 13 in rotation.
The valve repair device in the prior art is required to be adjusted to a clamping state before implantation and is implanted after being pressed and held, and the valve repair device clamping part is required to be pressed and held outside the implant connecting piece and the driving rod at the moment, so that the valve repair device has larger radial dimension after being pressed and held, blood vessels and hearts are extremely damaged in the implantation process, and potential safety hazards are larger. In the valve repairing device 1 provided by the invention, when the clamping component 13 is in the press-holding state, the valve repairing device 1 can be conveyed to a preset position to clamp target tissues, and as the radial size of all the clamping components 13 is smaller when the clamping component is in the press-holding state, the damage to blood vessels or hearts in the process of entering the valve repairing device 1 can be reduced, the reflux of atrioventricular valves can be effectively avoided, the success rate of a patient operation can be further improved, and the safety and reliability in the operation process can be improved.
It should be understood that the radial dimensions of all gripping members 13 refer to the outer diameter dimensions of all gripping members 13 at their maximum diameter. It should also be appreciated that the target tissue is the clamping location after implantation of the clamping member 13, in this embodiment the leaflets of the mitral or tricuspid valve.
With continued reference to fig. 1, the preferred embodiment of the present invention also provides a valve repair system comprising a valve repair device 1 and a delivery device 2, the delivery device 2 being detachably connected to the valve repair device 1, the delivery device 2 being for delivering the valve repair device 1 to a predetermined location in the body. It should be understood that the predetermined position refers to the target position to which the delivery valve repair device 1 is delivered, in this embodiment the position at which the mitral valve or tricuspid valve is located.
Referring to fig. 3, the gripping member 13 has a rotation angle θ of 0 ° to 180 ° with respect to the predetermined direction a.
The implantation process of the valve repair device 1 is as follows: the valve repair device 1 with the clamping component 13 in a pressed state is placed in the delivery device 2, and is implanted into a body along a channel established by the delivery device 2; when the distal end of the delivery device 2 is positioned at a predetermined position, the valve repair device 1 is pushed out from the distal end of the delivery device 2, the gripping member 13 is brought into a gripping state to grip the leaflet, and after the leaflet is successfully gripped, the gripping member 13 can be switched between a gripping state and a gripping state following opening and closing of the leaflet.
In more detail, the crimped state is a state in which the valve repair device 1 grips the member 13 when being delivered in the delivery device 2. Further, as shown in fig. 1 and 2, when the rotation angle θ of the gripping member 13 with respect to the predetermined direction a is 120 ° to 180 °, the gripping member 13 is in the press-grip state. So configured, the clamping members 13 are configured to avoid the implant connector 11 and the drive rod 12 when in a crimped state, wherein all of the clamping members 13 have a smaller radial dimension after crimping, thereby further avoiding damage to the patient's blood vessel and heart after implantation. Preferably, when the gripping member 13 is in the gripping state, the rotation angle θ of the gripping member 13 with respect to the predetermined direction a is 180 °, and the radial dimension of the gripping member 13 after gripping is minimized, so that the implantation process of the valve repair device 1 is safer and more reliable.
The grasping state is a state of the grasping member 13 when the valve repair device 1 grasps the target tissue. As shown in fig. 3 and 4, when the rotation angle θ of the gripping member 13 with respect to the predetermined direction a is 45 ° to 90 °, the gripping member 13 is in the gripping state.
The clamped state is a state of the grasping member 13 when the target tissue is closed, and as shown in fig. 5 to 7, the grasping member 13 is in the clamped state when the rotation angle θ of the grasping member 13 with respect to the predetermined direction a is 0 ° to 45 °.
In a preferred embodiment, the valve repair device 1 further comprises an actuator arm 14, and each gripping member 13 is provided with an actuator arm 14, one end of each actuator arm 14 being rotatably connected to the implant connector 11, and the other end being rotatably connected to a corresponding one of the gripping members 13. Such that when the driving rod 12 is moved in the axial direction of the implant connecting member 11, the driving rod 12 drives the gripping member 13 and the driving arm 14 to rotate relative to the implant connecting member 11, and in the process the driving arm 14 rotates relative to the gripping member 13, i.e. the gripping member 13 rotates relative to the predetermined direction a under the driving of the driving rod 12 and under the limitation of the driving arm 14. In other embodiments, the valve repair device 1 may further eliminate the actuator arm 14, and the gripping member 13 may be defined by a structure with the driving rod 12, such that the gripping member 13 may rotate with respect to the predetermined direction a only under the driving of the driving rod 12.
Referring to fig. 3, in the present embodiment, the grasping member 13 includes a grasping arm 131 and a grasping member 132, and the grasping arm 131 and the grasping member 132 are adapted to cooperate with each other to grasp the target tissue. The gripping arms 131 in each gripping member 13 are rotatably connected to the drive rod 12 and a corresponding one of the drive arms 14, respectively. The gripping members 132 in each gripping member 13 are connected to a corresponding one of the gripping arms 131 (i.e. the gripping arms 131 in the same gripping member 13). In more detail, the grasping members 132 in each of the grasping members 13 are fixedly connected to the grasping arms 131 on the proximal end side of the corresponding one of the grasping arms 131, as viewed in the grasping state of the grasping members 13.
Referring to fig. 1 to 4, the grasping member 132 is of an arc-shaped structure protruding toward the distal end of the driving rod 12, and the grasping member 132 is preferably annular, as viewed in the grasping state of the grasping member 13. In more detail, the gripping members 132 are all arc-shaped in a natural state (i.e., a state not limited by the delivery device 2), and when the gripping members 132 are placed in the delivery device 2 and can receive a force of the delivery device 2 in a radial direction, the gripping members 132 can form an arc-shaped structure with a larger arc or form a straight line structure after being stressed.
Because the valve leaflet has a certain radian, if the grabbing piece 132 is a planar structure, the grabbing piece 132 can only clamp the valve leaflet in a smaller area, so that the clamping area of the valve leaflet is reduced, the risk that the valve leaflet is separated from the valve repair device 1 is increased, and meanwhile, the clamped part of the grabbing piece 132 and the valve leaflet is broken or damaged due to repeated friction. The snatch piece 132 is set to the arc structure in this application, can make snatch piece 132 its arc surface and valve leaflet can carry out the subsides of great degree behind snatching the valve leaflet to can increase valve prosthetic devices 1 and the centre gripping area of valve leaflet, can also optimize the form after the valve leaflet centre gripping, even the form after the valve leaflet is by centre gripping is close its initial form, so that can reduce the stress and the damage that snatch piece 132 produced to the valve leaflet, then reducible patient's postoperative sick and ill symptoms, and ensure the security of valve prosthetic devices 1 long-term implantation.
Preferably, the gripping member 132 has elasticity. When the gripping member 13 is in the press-grip state, all the grasping pieces 132 can be elastically deformed to reduce the radial dimensions of all the grasping pieces 132. In this embodiment, the gripping member 132 is made of a superelastic material. So configured, when the gripping member 13 is in the press-grip state, the plurality of grasping pieces 132 can be pressed against each other and elastically deformed so that the radial dimensions of all the grasping pieces 132 are reduced, whereby the radial dimensions of the valve repair device 1 after press-grip can be further reduced. When the gripping member 13 is changed from the press-holding state to the grasping state, the grasping members 132 can be quickly restored to the initial state due to the loss of the interaction force of the plurality of grasping members 132, so as to facilitate grasping of the target tissue by the grasping members 132. In addition, the grasping element 132 made of the super-elastic material can also automatically adjust the shape of the grasping element 132 after grasping the valve leaflet (i.e., the target tissue) to accommodate the thickness of the valve leaflet of different patients, so that the versatility of the valve repair device 1 can be improved. It should be understood that the super elastic material refers to a material capable of being elastically deformed to a large extent by an external force and capable of recovering a state before the external force is applied when the external force is withdrawn. The specific materials for preparing the gripping member 132 are not limited in this application, and the materials for preparing the gripping member 132 include, but are not limited to, nickel-titanium alloy (NiTi) materials.
In the present embodiment, the clamp arm 131 is provided as a plate member. In other embodiments, the gripping arms 131 can be configured to engage the grasping elements 132 and grip the leaflet.
It will be appreciated that the implant connector 11, the drive rod 12, the drive arm 14 and the clamping arm 131 are all made of a rigid material, so that the valve repair device 1 can have sufficient rigidity and can always clamp the valve leaflets. Wherein the rigid material includes but is not limited to implantable stainless steel, cobalt chromium alloy (CoCr for short), high molecular material, etc. It should also be appreciated that the fixed connection between the gripping member 132 and the gripping arm 131 includes, but is not limited to, riveting, welding, stitching, hole-axis connection, snap-fit connection, or the like.
Preferably, the gripping members 13 further comprise a support member 133, wherein the support member 133 in each gripping member 13 is connected to a corresponding one of the clamping arms 131 (i.e. the clamping arms 131 in the same gripping member 13), and the support member 133 is configured to support the target tissue and increase the area of the target tissue to be clamped, so that the valve repair device 1 can more firmly grip the valve leaflet. It should be appreciated that the manner of the fixed connection between the support member 133 and the clamping arm 131 includes, but is not limited to, riveting, welding, stitching, hole axis connection, snap connection, or the like. In this embodiment, when the gripping member 13 is in a gripping state, the supporting member 133 is fixedly connected to the gripping arm 131 on the proximal side of the corresponding one of the gripping arms 131, and one end of the supporting member 133 is substantially fixed to a region closer to the distal end in the proximal side of the gripping arm 131, so that the supporting member 133 can be conveniently abutted against the leaflet.
The supporting member 133 is also preferably elastic. When the gripping member 13 is in the press-grip state, all the supporting pieces 133 can be elastically deformed to reduce the radial dimensions of all the supporting pieces 133. In this embodiment, the support 133 is also made of a super elastic material. So configured, when the gripping member 13 is in the crimped state, the plurality of supports 133 can be pressed against each other and elastically deformed so that the radial dimensions of all the supports 133 are reduced, whereby the radial dimensions of the valve repair device 1 after crimping can be further reduced. When the gripping member 13 is changed from the press-holding state to the grasping state, the supporting members 133 can be quickly restored to the original state due to the loss of the interaction force of the plurality of supporting members 133, so that the support of the leaflet can be realized. The specific materials for preparing the support 133 are not limited in this application, and the materials for preparing the support 133 include, but are not limited to, nickel-titanium alloy materials.
Preferably, when the gripping member 13 is in a gripping state, the supporting member 133 is in an arc structure protruding toward the proximal end of the driving rod 12, so that the shape of the leaflet can be better conformed to support the leaflet, and damage to the leaflet caused by long-time friction of the leaflet by the supporting member 133 can be avoided. In more detail, the supporting member 133 has an arc-shaped structure in a natural state (i.e., a state not limited by the delivery device 2), and when the supporting member 133 is placed in the delivery device 2 and can receive a force of the delivery device 2 in a radial direction, the supporting member 133 can form an arc-shaped structure with a larger arc or form a straight line structure after being subjected to the force.
Referring to fig. 4, in the present embodiment, the supporting member 133 has a ring-shaped structure and has a hollow inner cavity 1331, and the grasping member 132 can pass through the inner cavity 1331 and cooperate with the grasping arms 131 to grasp the target tissue, so that the area of the grasping member 13 grasping the leaflet can be increased, thereby firmly fixing the valve repair device 1 at the leaflet. After the support 133 is moved to a predetermined position in the body, the support 133 and the clamping arm 131 are placed on one side of the leaflet, the annular support 133 is abutted against and supports the leaflet, the proximal end of the grasping member 132 is pulled up, and when the leaflet is moved between the grasping member 132 and the clamping arm 131, the grasping member 132 is released, at which time the grasping member 132 can pass through the inner cavity 1331 of the support 133 and clamp the leaflet together with the clamping arm 131.
In this embodiment, the predetermined position is the mitral valve, so the number of the gripping members 13 is 2, that is, the number of the gripping arms 131, the gripping members 132 and the supporting members 133 is 2, and each gripping member 13 may grip one leaflet. And when the predetermined position is the tricuspid valve, the number of the grasping members 13 is 2 or 3.
Since the valve repair device 1 needs to fix the relative position between the transmission arm 14 and the clamping arm 131 in the grasping state after the valve repair device 1 is implanted in the body, even if the rotation angle θ of the grasping member 13 does not change, in order to grasp the valve leaflet. In the prior art valve repair device 1, however, a locking means is required between the drive rod 12 and the implant connector 11 to lock, even if the relative position between the drive arm 14 and the clamping arm 131 remains fixed. The locking device has a complex structure, so that the radial dimension of the valve repair device 1 after being pressed and held is large.
In a preferred embodiment, the implant connection 11 and the drive rod 12 are connected in a threaded connection which can be locked to one another. Specifically, the outer wall of the driving rod 12 is provided with an external thread, and the inner wall of the implant connecting piece 11 is provided with an internal thread matched with the external thread. The operator can rotate the drive rod 12 to move the drive rod 12 and implant connector 11 relative to each other, and after the drive rod 12 stops rotating, the drive rod 12 and implant connector 11 can be locked (i.e., the drive rod 12 and implant connector 11 can remain relatively stationary) without changing the positions of the actuator arm 14 and the clamp arm 131. When the positions of the driving arm 14 and the gripping arm 131 need to be changed, it is only necessary to continue rotating the driving lever 12 to the desired position, at which time the driving arm 14 and the gripping arm 131 can be locked relatively to another desired position. So configured, on the one hand, the drive rod 12 can be at rest so that the drive arm 14 and the clamping arm 131 can remain relatively stationary at any angle to grasp the leaflet; on the other hand, the provision of locking means between the transmission arm 14 and the clamping arm 131 is avoided in this way, whereby the number of parts of the valve repair device 1 can be reduced, which in turn further reduces the radial dimension of the valve repair device 1 after crimping.
Referring to fig. 5, the valve repair device 1 further includes a fixing member 15, the fixing member 15 is disposed at a distal end of the driving rod 12, and each of the clamping arms 131 is rotatably connected to the fixing member 15. Specifically, when the driving rod 12 is pulled from the distal end to the proximal end, the fixing element 15 gradually approaches the implant connecting element 11, and the fixing element 15 can drive the clamping arm 131 to drive the driving arm 14 to rotate relatively during the moving process, so that the rotation angle θ of the clamping member 13 changes. Specifically, when the fixing member 15 is located near the proximal end, the rotation angle θ of the gripping member 13 is 120 ° to 180 °, and the gripping member 13 is in a press-grip state. As the securing member 15 moves from the proximal end toward the distal end, the gripping member 13 may transition from the press-grip state to the gripping state. When the rotation angle θ of the gripping member 13 is 45 ° to 90 °, the gripping member 13 is in a gripping state. As the fixing member 15 continues to move from the proximal end toward the distal end, the gripping member 13 is changed from the gripping state to the gripping state, and when the fixing member 15 is positioned near the distal end, the rotation angle θ of the gripping member 13 is 0 ° to 45 °, and preferably approaches 0 ° depending on the physiological condition of the patient, at which time the gripping member 13 is in the gripping state.
Referring to fig. 4, in a preferred embodiment, each actuator arm 14 is provided with a recess 141, the recess 141 being adapted to receive the securing member 15 and a portion of the gripping arm 131 to enable the gripping member 13 to be rotated up to 180. In this embodiment, the driving arm 14 is of a thin plate structure, when the gripping member 13 is in a press-holding state, the fixing member 15 and a portion of the gripping arm 131 can pass through the groove 141, so that both the driving arm 14 and the gripping arm 131 can move to a position substantially parallel to the driving rod 12, and at this time, the rotation angle θ of the gripping member 13 is approximately 180 °, so that the distance between the plurality of gripping members 132 can be reduced, so that the plurality of gripping members 132 can be elastically deformed to a greater extent, and the radial dimension of the plurality of gripping members 132 can be further reduced. At the same time, the distance between the supporting pieces 134 can be reduced, so that the radial dimension of the supporting pieces 134 can be further reduced, and the radial dimension of the valve repairing device 1 after being pressed and held can be further reduced.
Referring to fig. 3, the valve repair system further includes a plurality of control wires 3, and each grasping element 132 is configured with one control wire 3, each grasping element 132 is configured to be connected with a corresponding one of the control wires 3, and each control wire 3 can be pulled so that the grasping element 132 grasps the target tissue. In more detail, after the valve repair device 1 is implanted at a predetermined position and the gripping member 13 is in a gripping state, the gripping member 132 can be pulled by the control wire 3 to elastically deform the gripping member 132, and when the leaflet moves between the gripping arm 131 and the gripping member 132, the control wire 3 is released, at which time the gripping member 132 is restored to an original state and can grip the leaflet together with the gripping arm 131.
The control wire 3 in the present application is preferably a flexible material, for example, nickel titanium wire, polymer wire or other types of wires may be used as the control wire 3.
For any of the above embodiments, in one non-limiting operation, taking mitral valve replacement as an example, the implantation procedure of the valve repair device 1 and delivery device 2 is:
referring to fig. 1 and 2, after the control wire 3 is fixedly connected to the distal end of the grasping member 132 before implantation of the valve repair device 1, the control wire 3 is extended to the distal end of the delivery device 2 while the driving rod 12 is moved to the proximal end, and the grasping member 13 is in a crimped state. The valve repair device 1 is then loaded in the delivery device 2 and delivered to the mitral valve location. After the distal end of the delivery device 2 is positioned at the mitral valve position, the valve repair device 1 is pushed out of the distal end of the delivery device 2. The drive rod 12 is then moved stepwise in the distal direction (i.e. away from the proximal end of the valve repair device 1) until the rotational angle θ of the gripping member 13 reaches 45 ° to 90 °, at which point the gripping member 13 is in a gripping state. The position of the support 133 is adjusted by the delivery device 2 so that the support bar 133 abuts the native valve leaflet. Pulling on the control wire 3 moves the proximal end of the grasping element 132 in a direction toward the implant connector 11, and since the grasping element 132 is made of a superelastic material, the grasping element 132 can be moved to a position substantially parallel to the axis of the drive rod 12 by pulling on the control wire 3. At the time between the clamping arm 131 and the grasping member 132 of the native valve She Jieyu, the control wire 3 is released, so that the native valve leaflet is abutted against the support 133 and clamped by the clamping arm 131 and the grasping member 132. The drive rod 12 is then moved stepwise in the distal direction (i.e., away from the proximal end of the valve repair device 1) so that the rotational angle θ of the gripping member 13 reaches 0 ° to 45 °, at which time the gripping member 13 is in the gripping state. This completes the fixation of the valve repair device 1 at the mitral valve position and causes the gripping members 13 to grip the leaflets.
Since the physiological condition (for example, the thickness of the native valve leaflet) of each patient is different, the actual rotation angle θ of the grasping member 13 in the grasping state is different for each patient. Preferably, the actual rotation angle θ of the clamping member 13 may be close to 0 ° according to the physiological conditions of different patients, so that the plurality of native valve leaflets can be better attached, and thus, reflux of blood can be more effectively avoided.
After the valve repair device 1 is in place, the control wire 3 is withdrawn proximally. The valve repair device 1 and the delivery device 2 are then separated. The delivery device 2 is withdrawn, i.e. implantation of the valve repair device 1 at the mitral valve position is completed.
In summary, in the valve repair device 1 and the valve repair system provided by the invention, the driving component in the valve repair device 1 can move along the axial direction to drive the clamping component 13 to rotate, and the clamping component 13 respectively has a clamping state, a grabbing state and a pressing state when rotating to different angles. So can reduce valve prosthetic devices 1 access in-process to the damage of blood vessel or heart, can also effectively avoid the backward flow of atrioventricular valve, and then can promote patient's success rate of operation to can improve security and reliability in the operation in-process.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention.
Claims (13)
1. A valve repair device, comprising a driving part and a plurality of clamping parts, wherein the clamping parts are used for clamping target tissues and are connected with the driving part;
the driving component is used for driving the clamping component to rotate, and the clamping component respectively has a clamping state, a grabbing state and a pressing and holding state when rotating to different angles, and can be switched among the clamping state, the grabbing state and the pressing and holding state;
the rotation angle of the gripping member in the press-holding state with respect to a predetermined direction, which is a direction in which the distal end of the driving member is directed to the proximal end, is larger than the rotation angle of the gripping member in the gripping state with respect to the predetermined direction, and is also larger than the rotation angle of the gripping member in the gripping state with respect to the predetermined direction.
2. The valve repair device of claim 1, wherein the valve repair device reaches the clamped state, the grasped state, and the crimped state sequentially as the angle of rotation of the gripping member relative to the predetermined direction increases.
3. The valve repair device of claim 1, wherein the gripping member is rotated at an angle of 0 ° to 180 ° relative to a predetermined direction.
4. The valve repair device of claim 3, wherein the gripping member is in the crimped state when the gripping member is rotated about the predetermined direction by an angle of 120 ° to 180 °.
5. The valve repair device of any one of claims 1-4, wherein the drive component comprises an implant connector and a drive rod movably disposed through the implant connector and coupled to the gripping component; the drive rod is configured to move axially of the implant connector to drive rotation of the gripping member.
6. The valve repair device of claim 5, further comprising an actuator arm, each of the gripping members being configured with one of the actuator arms, and each of the actuator arms having one end rotatably coupled to the implant connector and the other end rotatably coupled to a corresponding one of the gripping members.
7. The valve repair device of claim 6, wherein the gripping member comprises a gripping arm and a gripping member, the gripping member and the gripping arm being adapted to cooperate with each other to grip the target tissue;
the clamping arms in each clamping component are respectively connected with the driving rod and a corresponding transmission arm in a rotating way; the gripping members in each of the gripping members are connected to a corresponding one of the gripping arms.
8. The valve repair device of claim 7, further comprising a mount disposed at a distal end of the drive rod, each of the clamp arms being rotatably coupled to the mount;
and grooves are formed in each driving arm and are used for avoiding the fixing piece and part of the clamping arms, so that the clamping part can rotate to 180 degrees.
9. The valve repair device of claim 7, wherein each of the gripping members further comprises a support, the support in each of the gripping members being coupled to a corresponding one of the gripping arms, the support being for supporting the target tissue and for increasing the area of the target tissue gripped.
10. The valve repair device of claim 9, wherein the grasping element has elasticity; the grasping member is capable of being elastically deformed when the grasping member is in the press-held state to reduce the dimension of the grasping member in the radial direction of the driving rod,
and/or the support has elasticity; the support members are capable of being elastically deformed when the gripping member is in the press-held state to reduce the size of each of the support members in the radial direction of the drive rod.
11. The valve repair device of claim 9, wherein the gripping member is viewed in the grasped state; the support member is an arcuate structure protruding toward the proximal end of the drive rod and/or the grasping member is an arcuate structure protruding toward the distal end of the drive rod.
12. A valve repair system comprising a delivery device and the valve repair device of any one of claims 1-11, the delivery device being removably connected to the valve repair device, the delivery device being for delivering the valve repair device to a predetermined location.
13. The valve repair system of claim 12, wherein the gripping member comprises a grasping element, the valve repair system further comprising a plurality of control wires; each of the grasping elements is configured to be connected to a corresponding one of the control wires, each of the control wires being capable of being pulled so that the grasping element grasps the target tissue.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210778261.0A CN117357307A (en) | 2022-06-30 | 2022-06-30 | Valve repair device and valve repair system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210778261.0A CN117357307A (en) | 2022-06-30 | 2022-06-30 | Valve repair device and valve repair system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117357307A true CN117357307A (en) | 2024-01-09 |
Family
ID=89391634
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210778261.0A Pending CN117357307A (en) | 2022-06-30 | 2022-06-30 | Valve repair device and valve repair system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117357307A (en) |
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2022
- 2022-06-30 CN CN202210778261.0A patent/CN117357307A/en active Pending
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