CN114681143B - An adaptive valve clamping device and valve clamping system - Google Patents
An adaptive valve clamping device and valve clamping system Download PDFInfo
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- CN114681143B CN114681143B CN202011621758.9A CN202011621758A CN114681143B CN 114681143 B CN114681143 B CN 114681143B CN 202011621758 A CN202011621758 A CN 202011621758A CN 114681143 B CN114681143 B CN 114681143B
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- 210000004115 mitral valve Anatomy 0.000 description 14
- 230000006835 compression Effects 0.000 description 13
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- 230000000694 effects Effects 0.000 description 7
- 210000005240 left ventricle Anatomy 0.000 description 6
- 210000005246 left atrium Anatomy 0.000 description 5
- 206010027727 Mitral valve incompetence Diseases 0.000 description 4
- 239000000463 material Substances 0.000 description 4
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- 229910001220 stainless steel Inorganic materials 0.000 description 4
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—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
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a self-adaptive valve clamping device and a valve clamping system. The self-adaptive valve clamping device comprises a clamping assembly, a transmission assembly and an elastic self-locking piece. The clamping assembly includes a pair of openable and closable jawarms. The transmission assembly comprises a fixed base and a driving shaft movably penetrating the fixed base, each clamp arm is movably connected with the fixed base and the driving shaft, and axial movement of the driving shaft drives the clamp arms to open or close relative to the fixed base. The elastic self-locking piece is sleeved on the outer peripheral surface of the driving shaft, and two ends of the elastic self-locking piece in a natural state are positioned between the distal end of the fixed base and the proximal end of the driving shaft. The valve clamping device provided by the invention has the advantages that in the valve She Gage process, the deformation of the elastic self-locking piece is automatically and real-time adjusted along with the stress change of the valve leaflet, so that the clamp arm keeps applying flexible clamping force to the valve leaflet, the tearing caused by the traction of the valve She Guodu is avoided, the clamping force can be automatically adjusted along with the change of the valve leaflet gap, and the valve clamping device is suitable for a new valve leaflet gap.
Description
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a self-adaptive valve clamping device and a valve clamping system.
Background
The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, and a normally healthy mitral valve can control blood flow from the left atrium to the left ventricle while avoiding blood flow from the left ventricle to the left atrium. The mitral valve includes a pair of leaflets, called anterior and posterior, that when aligned with the edges of the anterior and posterior leaflets, as shown in fig. 1, the mitral valve can be fully closed to prevent blood flow from the left ventricle to the left atrium. When the leaflets of the mitral valve or their associated structures undergo an organic or functional change, the anterior and posterior leaflets of the mitral valve do not coapt properly, whereby the mitral valve does not close completely when the left ventricle of the heart contracts, resulting in blood regurgitation from the left ventricle to the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation".
Surgery typically employs surgical procedures such as valve edge-to-edge suturing to treat mitral regurgitation. However, the surgical operation has the defects of complex operation process, high operation cost, high wound degree of patients, high complication risk, long hospitalization time, pain of the recovery process of the patients and the like. The prior art discloses a minimally invasive treatment operation, which is based on the principle of edge-to-edge operation of a valve, a valve clamping device is conveyed to the mitral valve through an interventional catheter, and the anterior leaflet and the posterior leaflet of the mitral valve are clamped simultaneously through the relative opening and closing of clamps, so that the purposes of fixing the leaflets and reducing mitral regurgitation are achieved.
However, this valve clamping device is in a fixed, locked state after clamping the leaflets, and no relative displacement between the clamping members can occur. Too loose a clamping force can cause the valve clamping device to fall off from the valve leaflets during closing of the valve clamping device, too tight a clamping force can cause the two valve leaflets to be forcibly pulled towards each other and fixed together, so that the valve leaflets are excessively limited in movement and abnormal in mitral valve function, and too tight a clamping force can cause serious consequences such as the valve She Silie when the valve clamping device is in a beating state and the valve leaflets move, in addition, after the valve clamping device is implanted, as the implantation time is prolonged, reflux is relieved, valve morphology is correspondingly changed, and after the valve leaflet clearance is changed, the clamping force of the valve clamping device can be expected to be adjusted at the moment so as to gradually adapt to a new valve leaflet clearance.
Disclosure of Invention
One main object of the present invention is to overcome the defect that the clamping force of the existing valve clamping device cannot be adjusted in real time along with the movement of the valve leaflet or the clearance of the valve leaflet, and to provide an adaptive valve clamping device and a valve clamping system.
The present invention provides an adaptive valve clasper apparatus comprising:
The clamping assembly comprises a pair of openable and closable clamp arms;
the transmission assembly comprises a fixed base and a driving shaft movably penetrating the fixed base, each clamp arm is movably connected with the fixed base and the driving shaft, the axial movement of the driving shaft drives the clamp arms to open or close relative to the fixed base, and
The elastic self-locking piece is sleeved on the outer peripheral surface of the driving shaft, and two ends of the elastic self-locking piece in a natural state are positioned between the distal end of the fixed base and the proximal end of the driving shaft.
The invention also provides a valve clamping system, which comprises a conveying assembly and the self-adaptive valve clamping device with the structure, wherein the conveying assembly comprises a limiting pipe and a pushing shaft movably penetrating through the limiting pipe, the distal end of the pushing shaft is detachably connected with the proximal end of the driving shaft, and the distal end of the limiting pipe is detachably connected with the proximal end of the fixed base.
Compared with the prior art, the self-adaptive valve clamping device and the valve clamping system have the advantages that the driving shaft is arranged in the fixed base in a sliding mode, the clamp arms form an openable structure relative to the fixed base along with the movement of the driving shaft, the sliding distance of the driving shaft directly determines the opening degree of the clamp arms, and meanwhile the clamp arms are locked at a certain opening angle relative to the fixed base through the deformation degree of the elastic self-locking piece. In the clamping flap She Guocheng, the elastic self-locking piece is driven by the driving force of the driving shaft, on one hand, the elastic self-locking piece is driven by the traction force transmitted by the clamp arm to the far end of the fixed base, and the traction force of the clamp arm is from the valve leaflet, so that the deformation of the elastic self-locking piece is automatically adjusted in real time along with the stress change of the valve leaflet, the clamp arm can keep applying flexible clamping force to the valve leaflet, the valve leaflet is prevented from being forcibly pulled by excessive clamping force, and secondary damage to the valve leaflet is prevented. Therefore, the elastic self-locking piece can not only realize the locking of the clamp arm relative to the fixed base, but also self-adaptively adjust the clamping force of the clamp arm on the valve leaflet so as to provide flexible clamping force for the valve leaflet, avoid tearing caused by the traction of the valve She Guodu and accelerate the valve leaflet to recover to the normal involution level, and can also automatically adjust the clamping force along with the change of the valve leaflet clearance after the valve clamping device is implanted, thereby being suitable for the new valve leaflet clearance.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.
In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, and it will be obvious to a person skilled in the art that other drawings can be obtained from these drawings without inventive effort.
Fig. 1 is a perspective view of a valve clasper apparatus in accordance with a first embodiment of the present invention in an expanded configuration.
Fig. 2 is an elevation view of a valve clasper apparatus in accordance with a first embodiment of the present invention in an expanded configuration.
Fig. 3 is a perspective view of a valve clasper apparatus in accordance with a first embodiment of the present invention in an expanded configuration.
Fig. 4 is a longitudinal cross-sectional view of a valve clasping apparatus in accordance with a first embodiment of the present invention in an expanded configuration.
Fig. 5 is a perspective view of a valve clasper in accordance with a first embodiment of the present invention in a closed configuration.
Fig. 6 is a front view of a valve clasper apparatus in accordance with a first embodiment of the present invention in a closed configuration.
Fig. 7 is a longitudinal cross-sectional view of a valve clasper apparatus in accordance with a first embodiment of the present invention in a closed configuration.
Fig. 8 is a perspective view of a fixing base according to a first embodiment of the present invention.
Fig. 9 is a longitudinal sectional view of a fixing base according to a first embodiment of the present invention.
Fig. 10 is an exploded view of a drive pin according to a first embodiment of the present invention.
Fig. 11 is a perspective view of a fixing base of another structure according to the first embodiment of the present invention.
Fig. 12 is a longitudinal sectional view of a fixing base of another structure according to the first embodiment of the present invention.
Fig. 13 is a perspective view of an elastic self-locking member according to a first embodiment of the present invention.
Fig. 14 is a perspective view of an elastic self-locking member with another structure according to the first embodiment of the present invention.
Fig. 15 is a perspective view of a drive shaft according to a first embodiment of the present invention.
Fig. 16 is a longitudinal sectional view of a drive shaft according to a first embodiment of the present invention.
Fig. 17 is a partial perspective view of a valve clasper system in accordance with a first embodiment of the present invention.
Fig. 18 is a perspective view of a valve clasper apparatus in accordance with a second embodiment of the present invention in an expanded configuration.
Fig. 19 is a front view of a valve clasper apparatus in accordance with a second embodiment of the present invention in an expanded configuration.
Fig. 20 is a longitudinal cross-sectional view of a valve clasping apparatus in accordance with a second embodiment of the present invention in an expanded configuration.
Fig. 21 is a perspective view of a valve clasper apparatus in accordance with a second embodiment of the present invention in a closed configuration.
Fig. 22 is a longitudinal cross-sectional view of a valve clasper apparatus in accordance with a second embodiment of the present invention in a closed configuration.
Fig. 23 is a perspective view of a fixing base according to a second embodiment of the present invention.
Fig. 24 is a longitudinal sectional view of a fixing base according to a second embodiment of the present invention.
Fig. 25 is a perspective view of a drive shaft according to a second embodiment of the present invention.
Fig. 26 is a longitudinal sectional view of a drive shaft according to a second embodiment of the present invention.
Fig. 27 is a perspective view of a valve clasper apparatus in accordance with a third embodiment of the present invention in an expanded configuration.
Fig. 28 is an elevation view of a valve clasper apparatus in accordance with a third embodiment of the present invention in an expanded configuration.
Fig. 29 is a perspective view of a valve clasper apparatus in accordance with a third embodiment of the present invention in a closed configuration.
Fig. 30 is a front view of a valve clasper apparatus in accordance with a third embodiment of the present invention in a closed configuration.
Fig. 31 is a perspective assembly view of a fixing base, a driving shaft and an elastic self-locking member according to a third embodiment of the present invention.
Fig. 32 is a forward assembly view of a stationary base, a drive shaft and a resilient self-locking member according to a third embodiment of the present invention.
Fig. 33 is a perspective assembly view of the fixing base, the driving shaft and the elastic self-locking member in a stretched state according to the third embodiment of the present invention.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
It should be understood that the directions or positional relationships indicated by "front", "rear", "upper", "lower", "left", "right", "longitudinal", "transverse", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", etc. are configured and operated in a specific direction based on the directions or positional relationships of the drawings, are merely for convenience of description of the present invention, and do not indicate that the apparatus or element referred to must have a specific direction, and thus should not be construed as limiting the present invention.
It should also be noted that unless explicitly stated or limited otherwise, terms such as "mounted," "connected," "secured," "disposed," and the like are to be construed broadly, and may be fixedly connected, detachably connected, or integrally formed, directly connected, indirectly connected via an intermediate medium, or in communication between two elements or in an interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or one or more intervening elements may also be present. 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, it should be still noted that, the proximal end refers to the end of the instrument or component that is close to the operator, the distal end refers to the end of the instrument or component that is far away from the operator, the axial direction refers to the direction parallel to the line connecting the distal end and the center of the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction around the axial direction.
In order to overcome the defect that the clamping force of the valve clamping structure in the prior art cannot be adjusted in real time, the invention discloses a self-adaptive valve clamping device 1000 and a valve clamping system, wherein the clamping force of a clamp arm 110 to valve leaflets is automatically adjusted in real time by flexible force to the valve She Shijia. The invention is illustrated in detail below by means of specific examples and the accompanying drawings.
Example 1
Referring to fig. 1-4, an embodiment of the present invention discloses an adaptive valve clamping device 1000, which includes a clamping assembly 100, a transmission assembly 200, and a resilient self-locking member 300. The clamping assembly 100 includes a pair of openable and closable jawarms 110. The transmission assembly 200 includes a fixed base 210 and a driving shaft 220 movably penetrating the fixed base 210, each of the jawarms 110 is movably connected with the fixed base 210 and the driving shaft 220, and axial movement of the driving shaft 220 drives the jawarms 110 to open or close relative to the fixed base 210. The elastic self-locking member 300 is sleeved on the outer peripheral surface of the driving shaft 220, and two ends of the elastic self-locking member 300 in a natural state are located between the distal end of the fixed base 210 and the proximal end of the driving shaft 220.
According to the technical scheme of the invention, the driving shaft 220 is slidably arranged in the fixed base 210, the clamp arm 110 forms an openable structure relative to the fixed base 210 along with the movement of the driving shaft 220, the sliding distance of the driving shaft 220 directly determines the opening and closing degree of the clamp arm 110, and meanwhile, the clamp arm 110 is locked at a certain opening and closing angle relative to the fixed base 210 through the deformation degree of the elastic self-locking piece 300. In the clamping flap She Guocheng, the elastic self-locking member 300 receives the driving force of the driving shaft 220, receives the pulling force transmitted from the clamp arm 110 to the distal end of the fixed base 210, and the pulling force of the clamp arm 110 comes from the valve leaflet, so that the deformation of the elastic self-locking member 300 is automatically adjusted in real time along with the stress change of the valve leaflet, thereby the clamp arm 110 keeps applying flexible clamping force to the valve leaflet, and the valve leaflet is prevented from being pulled forcibly by excessive clamping force, so that secondary damage to the valve leaflet is prevented. Therefore, the elastic self-locking piece 300 not only can lock the clamp arm 110 relative to the fixed base 210, but also can adaptively adjust the clamping force of the clamp arm 110 on the valve leaflet so as to provide a flexible clamping force on the valve leaflet, avoid tearing caused by the traction of the valve She Guodu and accelerate the valve leaflet to restore to the normal involution level, and can automatically adjust the clamping force along with the change of the valve leaflet clearance after the valve clamping device 1000 is implanted, thereby being suitable for a new valve leaflet clearance.
The adaptive valve clasper apparatus 1000 of the present invention is deliverable by a delivery assembly 2000. The self-adaptive valve clamping device 1000 is simple in structure, does not need a complex self-locking mechanism, does not need additional unlocking control operation, is easy to operate, shortens operation time, improves operation success rate, does not need an unlocking control mechanism in the conveying assembly 2000, reduces assembly difficulty of the conveying assembly 2000, and ensures stability of the conveying system. In addition, the overall weight of the valve clamping device 1000 can be reduced, the load on the valve leaflets can be reduced, and the fatigue resistance of the valve clamping device 1000 can be improved.
The clamping assembly 100 further includes a pair of clamping arms 120, each clamping arm 120 is disposed opposite to one of the jawarms 110, one end of the clamping arm 120 is connected to the fixed base 210, and the other end of the clamping arm 120 is opened and closed relative to the fixed base 210. When the arms 110 are closed relative to the fixed base 210, the anterior and posterior leaflet of the mitral valve are clamped between one arm 110 and one side of the clamping arm 120, respectively.
In this embodiment, the distal end of the jawarm 110 is provided with a coupling slot 111, and a driving pin 2201 is inserted into the coupling slot 111, thereby coupling the jawarm 110 with the driving shaft 220. When the driving shaft 220 is pulled proximally, the driving pin 2201 moves proximally and slides relatively with the connecting slot 111 of the jawarm 110, so as to drive the jawarm 110 to rotate about the driving pin 2201, thereby expanding the jawarm 110 and the fixed base 210. When the driving shaft 220 is pulled distally, the driving pin 2201 moves distally and slides relatively with the connecting slot 111 of the jawarm 110, so as to drive the jawarm 110 to rotate about the driving pin 2201, thereby closing the jawarm 110 and the fixed base 210.
Referring to fig. 5-7, the inner surface of the clamp arm 110 opposite the fixed base 210 serves as a leaflet clamping surface, so that in order to better accommodate the configuration of the leaflet and ensure proper leaflet contact area and clamping area, thereby providing a stable clamping force, the clamp arm 110 is preferably a sheet having a concave inner surface and has a width and axial length, specifically, the width of the clamp arm 110 should be greater than or equal to 2mm, preferably 4-6mm, and the axial length of the clamp arm 110 should be greater than or equal to 4mm, preferably 6-12mm. To ensure post-implantation safety, the jawarms 110 should be made of biocompatible materials and have a degree of flexibility and rigidity. And an active agent may also be applied to the inner surface of the arms 110 to promote endothelial cell coverage and growth of leaflet tissue on the inner surface of the arms 110.
It will also be appreciated that in order to increase the clamping force of the clamping arm 120 and the jawarm 110 against the leaflet, at least one row of barbs may also be provided on the surface of the clamping arm 120 facing the jawarm 110 to prevent the leaflet from slipping off the inner surface of the jawarm 110.
Each clamping arm 120 includes an oppositely disposed connecting end and a free end, the connecting end being fixed relative to the fixed base 210. In this embodiment, the two clamping arms 120 are integrally connected by a connecting frame, the connecting frame is provided with a through hole for the driving shaft 220 to pass through, and the connecting frame is sleeved on the outer side of the fixed base 210. In other embodiments, the connection end of the clamping arm 120 may be directly fixed to the fixing base 210 by welding, crimping, or the like.
The clamping arm 120 is at least partially made of an elastic material having a shape memory function and is heat-set. In its natural state, the clamping arms 120 radiate outwardly relative to the fixed base 210 and preferably extend proximally to facilitate engagement with the clamp arms 110 to clamp valve tissue. In this embodiment, the clamping arms 120 are integrally formed of a superelastic nickel-titanium alloy, thereby providing the clamping arms 120 with a greater elastic force to urge the clamping arms 120 toward the clamp arms 110 to clamp valve tissue.
It should be noted that, the free end of the clamping arm 120 is provided with a control wire hole for connecting a control wire (not shown) of the pushing device, and the free end of the clamping arm 120 can be controlled by the control wire extending outside the patient. In the delivery state, the free end of the clamping arm 120 is pulled by the control wire and is attached to the surface of the fixed base 210, and after the control wire is released to control the free end, the clamping arm 120 is released, the clamping arm 120 is restored to the natural state due to its elastic memory property, and the petals She Yaxiang are clamped to the arms 110.
It will be appreciated that, to increase the biocompatibility between the valve clamping device 1000 and the valve leaflet, the gripping surface of the clamp arm 110 (i.e., the surface facing the clamp arm 120) and the gripping surface of the clamp arm 120 (i.e., the surface facing the clamp arm 110) may be further coated with a biocompatible polymer film, which is selected from materials such as polyethylene terephthalate (polyethylene terephthalate, PET), polytetrafluoroethylene (PTFE), and the like, and the materials of the coating applied to the clamp arm 110 and the clamp arm 120 may be the same or different.
Preferably, referring to fig. 8 and 9, the fixing base 210 includes a base 211 and a tube 212 disposed at a proximal end of the base 211, the base 211 is movably connected to the jawarms 110, and a shaft hole 213 through which the driving shaft 220 passes is formed in the base 211 and the tube 212. In this embodiment, the base 211 is rotatably connected to the jawarms 110 by a rotation pin 112. The shaft hole 213 serves as a stopper and guide for the driving shaft 220. The shaft hole 213 is specifically provided as a circular hole, which is fitted to the outer peripheral surface of the drive shaft 220. Two pin holes are provided on both sides of the distal end of the fixed base 210 for receiving the rotation pins 112.
Referring to fig. 10, one end of the driving pin 2201 of the embodiment is a smooth hemispherical protrusion, the other end is provided with a radially protruding pin collar, when the driving pin 2201 is inserted into the connecting slot 111, the driving pin 2201 and the jawarm 110 do not need to be welded, the driving pin 2201 and the jawarm 110 rotate relatively, and the hemispherical protrusion and the pin collar cooperate to prevent the driving pin 2201 from falling out of the connecting slot 111 of the jawarm 110. The structure of the rotation pin 112 may be the same as that of the driving pin 2201.
Preferably, referring to fig. 9, the shaft hole 213 is provided with a stepped surface 2130 protruding inward, and one end of the elastic self-locking member 300 abuts against or is connected to the stepped surface 2130. The step surface 2130 plays a circumferential limiting role on the elastic self-locking piece 300, so that the elastic self-locking piece 300 is prevented from being retracted along with the driving shaft 220, and the device is prevented from being disabled, and the stability of elastic force is ensured.
Further, the shaft hole 213 includes a first hole 2131 and a second hole 2132 connected, the first hole 2131 having a smaller diameter than the second hole 2132. The junction of the first hole 2131 and the second hole 2132 forms a stepped surface 2130, and the resilient self-locking member 300 is received in the second hole 2132. The first hole 2131 is used for accommodating and guiding the driving shaft 220, the second hole 2132 is used for accommodating the elastic self-locking piece 300, and the sizes of the first hole 2131 and the second hole 2132 are respectively matched with those of the driving shaft 220 and the elastic self-locking piece 300 so as to achieve the limiting and guiding effects, and avoid the driving shaft 220 and the elastic self-locking piece 300 from being axially skewed, and the closing of the clamp arm 110 and the transmission of elastic force are influenced.
Preferably, the first and second bores 2131, 2132 open distally along the proximal end of the stationary base 210 in sequence, with the resilient self-locking element 300 interposed between the distal end of the drive shaft 220 and the stepped surface 2130. Of course, the positions of the first and second apertures 2131 and 2132 may be adjusted based on the positions of the drive shaft 220 and the resilient self-locking member 300. In this embodiment, the distal end of the resilient self-locking member 300 extends at least partially out of the second aperture 2132, and the resilient self-locking member 300 reaches a maximum extension when the two jawarms 110 of the valve clamping device 1000 are clamped. This structure can shorten the overall length of the fixing base 210, and make the fixing base 210 smaller in size and smaller in dead weight.
Further, referring to fig. 11 and 12, in order to reduce the weight of the valve clasping apparatus 1000, weight-reducing holes 215 or weight-reducing slots 2111 may be added to the fixed base 210. The fixing base 210 may be made of a biocompatible material having a certain hardness and rigidity, and stainless steel is used in this embodiment.
Preferably, referring to fig. 13, the elastic self-locking member 300 is a spring 310, and the driving shaft 220 is disposed through the spring 310. The elastic self-locking member 300 is in the form of a spring 310, which is simple and convenient. The spring 310 can be made of stainless steel with better elasticity, or made of nickel-titanium wires with super elasticity through winding and heat setting. The spring 310 of the present embodiment is a compression spring, that is, the external force applied to the spring 310 from the initial state to the deformed state is a compressive force. It will be appreciated that when the jawarms 110 are in the closed condition, the spring 310 is in an initial condition in which the spring 310 is slightly compressed. The spring 310 compresses more as the drive shaft 220 is pulled proximally and the jawarms 110 are in an open condition, and when the drive shaft 220 is pushed distally, the spring 310 returns to its original condition, slightly compressed, and the jawarms 110 are in a closed condition and locked relative to the stationary base 210.
Referring to fig. 14, in other embodiments, the elastic self-locking member 300 includes a plurality of stacked elastic sheets 320, and a through hole 321 is formed in the middle of the elastic sheet 320 for the driving shaft 220 to pass through. Specifically, a plurality of elastic sheets 320 which are sequentially connected and overlapped end to end can be made of elastic materials to be used as the elastic self-locking member 300, for example, stainless steel materials with better elasticity can be used for bending, super-elastic nickel titanium sheets can be used for heat setting, and spring steel can be used for coating treatment to obtain the elastic self-locking member 300. The operation principle of the plurality of stacked spring plates 320 is identical to that of the compression spring 310, and will not be described herein.
It will be appreciated that the resilient self-locking member 300 is slightly compressed and provides a certain elastic force as the self-locking force of the valve clamping device 1000 when the valve leaflet is in the closed state, and when the pulling force of the leaflet against the forceps arm 110 exceeds the self-locking force, the forceps arm 110 overcomes the self-locking force provided by the resilient self-locking member 300 to generate an adaptive adjustment effect, so as to prevent the forceps arm 110 from excessively pulling the leaflet. Under the thrust force of the pushing shaft 2200 or the traction force of the valve leaflet, the compression deformation amount of the elastic self-locking member 300 gradually increases with the increase of the opening angle of the clamp arm 110, and when the valve clamping device 1000 is opened to the maximum angle, the elastic self-locking member 300 reaches the compression limit position, and the self-locking force (elastic force of the elastic self-locking member 300) that the clamp arm 110 needs to overcome is the maximum.
The self-locking force provided by the elastic self-locking piece 300 is tested by adopting an HY-0580 type electronic universal tensile testing machine manufactured by Shanghai scale wing precision instruments, inc., connecting the valve clamping device 1000 with a simple handle, connecting a testing shaft with a driving shaft 220 and penetrating out from the proximal end of the simple handle, fixing the simple handle on a machine table of a tensile machine, hooking the moving end of the tensile machine to the tail end of the testing shaft, moving the moving end at a constant speed of 4.5mm/min, and recording the force value of movement of the clamp arm 110 from an initial closed state and the force value required by the clamp arm 110 to be opened to a maximum angle. The self-locking force of the valve clasper 1000 in the initial state was measured to be 15-20N and the self-locking force of the valve clasper 1000 when opened to a maximum angle was measured to be 40-50N. Therefore, in order to better clamp the valve and maintain the clamping effect, on the one hand, and on the other hand, ensure that the self-adaptive adjustment function can be generated when a large pulling force is applied, the self-locking force range provided by the elastic self-locking member 300 is 15-50N, and the self-locking force range is the elastic force range of the elastic self-locking member 300.
Preferably, the elastic coefficient of the elastic self-locking member 300 ranges from 1.5 to 10N/mm, which can be obtained through experiments and calculations. Specifically, the elastic self-locking element 300 is a compression spring 310, and the elastic self-locking element 300 is not assembled in the valve clasper 1000 when in the original length. When the elastic self-locking member 300 is slightly compressed and assembled in the valve clamping device 1000, the two clamp arms 110 on both sides of the valve clamping device 1000 are closed, the elastic self-locking member 300 is slightly compressed axially, the slightly compressed length is the axial distance between the limiting surface of the driving shaft 220 and the step surface 2130 of the inner shaft hole 213 of the fixing base 210, the first axial deformation of the elastic self-locking member 300 is the difference between the original length and the installed compressed length, the range is 1-5 mm, and the self-locking force provided by the elastic self-locking member 300 is 15-20N. The driving shaft 220 is gradually pushed to drive the clamp arm 110 to open towards two sides relative to the fixed base 210, the elastic self-locking piece 300 is further compressed axially, when the clamp arm 110 is at the maximum opening angle, the elastic self-locking piece 300 reaches the limit compression position, the compressed length is the axial distance between the limiting surface of the driving shaft 220 and the step surface 2130 of the inner shaft hole 213 of the fixed base 210, namely, the second axial deformation of the elastic self-locking piece 300 is the difference between the original length and the limit compression length, the range is 5-10 mm, and the self-locking force provided by the elastic self-locking piece 300 is 40-50N at the moment. According to hooke' S law F=KS, F is the elasticity of the elastic self-locking piece 300, K is the elasticity coefficient of the elastic self-locking piece 300, S is the compression amount of the elastic self-locking piece 300, and the elasticity coefficient K [ N/mm, lb/in ] of the elastic self-locking piece 300 can be calculated to be 1.5-10N/mm.
In this embodiment, a stainless steel compression spring 310 is used as the elastic self-locking member 300, and the calculation formula of the spring coefficient K of the compression spring 310 is known as followsWherein, K=elastic coefficient [ N/mm, lb/in ], G=shear elastic modulus [ MPa, psi ], d=wire diameter [ mm, in ], n=effective circle number (- ], D=center diameter [ mm, in ], shear elastic modulus G is 7000MPa, wire diameter D is 0.30mm, total circle number is 9, effective circle number N is 7, center diameter D is 1.20mm, elastic coefficient K=5.74N/mm 300. It is understood that in other embodiments, parameters such as material, wire diameter, shear elastic modulus, center diameter, effective number of turns, total length of spring of the elastic self-locking member 300 may be changed, so long as the elastic coefficient of the elastic self-locking member 300 is within the range of 1.5-10 n/mm, and the self-locking force requirement of the present invention may be satisfied.
Preferably, referring to fig. 15 and 16, the distal end of the driving shaft 220 is provided with a supporting seat 221, and one end of the elastic self-locking member 300 is abutted or connected to the supporting seat 221. The supporting seat 221 is used for providing an abutting position or a connecting (welding) position for the elastic self-locking member 300, and providing a stable supporting surface for the elastic self-locking member 300. In the present embodiment, the support base 221 is provided with a driving pin hole 222, and the driving pin 2201 is provided in the driving pin hole 222 of the support base 221. The driving pin hole 222 is provided in the support base 221, so that the driving pin hole 222 can be prevented from adversely affecting the overall strength of the driving shaft 220.
Further, the jawarms 110 are rotatably coupled to the stationary base 210, and the jawarms 110 are slidably coupled to the drive shaft 220 or rotatably coupled thereto. In this embodiment, the arm 110 is rotatably connected to the fixed base 210, the arm 110 is slidably connected to the drive shaft, and the axial movement of the drive shaft 220 is converted into a rotational opening/closing movement of the arm 110 by a combination of the rotational and sliding movements. In other embodiments, the positions of the rotary and sliding connections may be adjusted to achieve the same operational result.
Referring to fig. 17, the present invention also discloses a valve clamping system comprising a delivery assembly 2000 and an adaptive valve clamping device 1000 of the above-described construction. The delivery assembly 2000 includes a stop tube 2100 and a push shaft 2200 movably mounted in the stop tube 2100. The distal end of the push shaft 2200 is detachably connected to the proximal end of the drive shaft 220, and the distal end of the stopper tube 2100 is detachably connected to the proximal end of the stationary base 210.
It will be appreciated that the proximal end of the valve clasper 1000 is releasably connected to the pushing shaft 2200 and the stop tube 2100, the operator pushes the valve clasper 1000 to the mitral valve of the patient, then remotely operates the valve clasper 1000 to clamp the anterior and posterior leaflets of the mitral valve together, once the leaflets of the mitral valve are coaptated edge-to-edge, the operator can release the connection between the pushing shaft 2200 and the valve clasper 1000, such that the valve clasper 1000 is released from the distal end of the pushing shaft 2200 and remains in the patient as an implant to hold the coaptation position of the leaflets together, reducing mitral regurgitation in the patient.
The driving shaft 220 is disposed in the shaft hole 213 of the fixed base 210 and is axially slidable, a driving pin hole 222 is provided at a distal end of the driving shaft 220, and a driving pin 2201 is inserted into the driving pin hole 222 and connected to the jawarm 110, thereby driving the opening and closing of the jawarm 110 with respect to the fixed base 210. The proximal end of the drive shaft 220 is provided with a threaded section 223 for releasable connection with the push shaft 2200 of the delivery assembly 2000 to remotely control the axial advancement or retraction of the drive shaft 220 relative to the stationary base 210 outside the patient's body.
Wherein, limit tube 2100 is used for with valve clamp device 1000 detachable connection, push shaft 2200 movably wears to establish in limit tube 2100, and push shaft 2200's distal end is detachable connection through the screw thread with drive shaft 220. The push shaft 2200 is used to control the axial advance or retraction of the drive shaft 220 relative to the fixed base 210, i.e., to drive the opening or closing of the jawarms 110 relative to the fixed base 210. The pushing shaft 2200 is also used to control the connection and disconnection between the stop tube 2100 and the valve clasper 1000, and when the pushing shaft 2200 is withdrawn from the stop tube 2100, the valve clasper 1000 is disconnected from the stop tube 2100.
The delivery assembly 2000 also includes an adjustment wire for controlling the release and tightening of the free ends of the clamp arms 120. The stop tube 2100, the push shaft 2200, and the adjustment wire each have an axial length and extend outside the patient's body so that an operator can remotely operate outside the patient's body to control the valve clamping device 1000 to clamp the leaflets, disengage, and release. A handle may also be provided at the proximal ends of the stop tube 2100 and the push shaft 2200 for ease of manipulation by the operator.
Preferably, referring again to fig. 8-12, the proximal end of the fixed base 210 is provided with at least one clamping groove 214, and the distal end of the stop tube 2100 is provided with a clamping piece 2110 that is in shape fit with and corresponds to the clamping groove 214. Thus, the fixing base 210 and the stopper tube 2100 form a detachable engagement structure by the engagement of the engagement groove 214 with the engagement piece 2110. Before the clamping is completed, the fixed base 210 and the limit tube 2100 maintain the clamping state, the pushing shaft 2200 slides in the limit tube 2100, the driving shaft 220 slides through threads to further control the opening and closing of the clamp arm 110, and after the clamping is completed, the fixed base 210 and the limit tube 2100 are separated from the clamping state and are switched into two independent components, so that the conveying assembly 2000 is convenient to retract.
Preferably, the free end of the engagement piece 2110 is engaged into the fixed base 210, and the engagement piece 2110 is engaged into the fixed base 210 to a depth greater than the gap between the push shaft 2200 and the stopper tube 2100. The engagement piece 2110 is engaged with the fixed base 210, and is pressed against the outer circumferential surface of the push shaft 2200 to maintain the engagement state between the stopper tube 2100 and the fixed base 210, and the position of the push shaft 2200 is controlled to change the connection relationship between the stopper tube 2100 and the fixed base 210. In this embodiment, the engaging piece 2110 is provided as a T-shaped spring piece. Specifically, the distal end of the limiting tube 2100 is symmetrically provided with two T-shaped elastic pieces 320, and each T-shaped elastic piece 320 is radially biased inward in a natural state. When the pushing shaft 2200 is inserted into the limiting tube 2100, the pushing shaft 2200 pushes up the T-shaped elastic pieces 320 radially outwards, so that each T-shaped elastic piece 320 is embedded into one T-shaped groove of the fixed base 210, and the fixed base 210 and the limiting tube 2100 are connected. When the pushing shaft 2200 is retracted from the stopper tube 2100, the T-shaped spring piece 320 of the stopper tube 2100 is deformed inward and separated from the T-shaped groove by being separated from the interference of the pushing shaft 2200, and the fixing base 210 and the stopper tube 2100 are in an unlocked state.
The following is the operation of the valve clasper device 1000:
After the valve clamping device 1000 reaches the leaflet, the pushing shaft 2200 is rotated to move the driving shaft 220 in the axial direction and drive the forceps arms 110 to open, and when the leaflet enters between the forceps arms 110 and the clamping arms 120, the clamping arms 120 are released to naturally close the clamping arms 120 towards the forceps arms 110 and clamp the leaflet tissue.
The pushing shaft 2200 is rotated in the opposite direction, causing the drive shaft 220 to move in the opposite direction in the axial direction and to cause the jawarms 110 to grip, thereby causing the petals She Gage to be moved.
After the valve clamping device 1000 clamps the leaflets, the threaded connection between the pushing shaft 2200 and the driving shaft 220 of the valve clamping device 1000 is released, then the pushing shaft 2200 is withdrawn from the limiting tube 2100, the T-shaped spring sheet 320 on the limiting tube 2100 is biased inward to be separated from the fixing base 210 of the valve clamping device 1000, and the whole valve clamping device 1000 is disconnected from the delivery assembly 2000 and released quickly, after which the valve clamping device 1000 can maintain the flexible clamping effect under the elastic force of the elastic self-locking member 300.
When the leaflet tension reaches a certain force value, the clamp arm 110 overcomes the elastic force of the elastic self-locking element 300 and adjusts the closing state, and the whole closing process is a flexible self-adapting process, so that the flap She Silie is avoided. In addition, from the perspective of the long-term effect after the implantation of the valve clamping device 1000, as the heart function is recovered, the ventricular structure recovery and the leaflet coaptation effect are gradually improved, the forceps arms 110 can automatically adjust the closing angle under the action of the flexible clamping force provided by the elastic self-locking element 300, so as to avoid the leaflet from tearing and accelerate the leaflet to recover to the normal coaptation level, and further ensure the operation effect.
Example two
Referring to fig. 18-22, a valve clamping device 1000 according to a second embodiment of the present invention has substantially the same structure as the first embodiment, the clamp arm 110 is rotatably connected to the fixed base 210, and the clamp arm 110 is slidably connected to the driving shaft 220, except that the rotation pin 112 and the driving pin 2201 are disposed at different positions of the clamp arm 110 and sequentially from the near to the far along the axial direction of the valve clamping device 1000. The jawarms 110 are in an open condition when the drive shaft 220 is pushed distally and the jawarms 110 are in a closed condition when the drive shaft 220 is pulled proximally. In this embodiment, the elastic self-locking member 300 is also a pressure spring 310, that is, the external force from the initial state to the deformed state is pressure, and the elastic force of the elastic self-locking member 300 acts between the fixed base 210 and the driving shaft 220.
The valve clamping device 1000 has the structural advantages that (1) the size of the fixed base 210 is smaller and the structure is compact, (2) the guide groove 113 of the driving pin 2201 is arranged on the fixed base 210, the movement of the valve clamping device 1000 in the opening and closing process is more stable, and (3) the elastic self-locking piece 300 is integrally accommodated in the fixed base 210, so that the flexible clamping effect is more stable.
Referring to fig. 23 and 24, the second hole 2132 and the first hole 2131 are sequentially opened along the proximal end of the fixing base 210 toward the distal end, and the elastic self-locking member 300 is disposed between the proximal end of the driving shaft 220 and the stepped surface 2130. The elastic self-locking member 300 is disposed in the second hole 2132 and is contained inside the fixed base 210, which is further helpful for improving the stability of the elastic self-locking member 300.
Referring to fig. 25 and 26, preferably, the proximal end of the drive shaft 220 is provided with a boss 224, and one end of the resilient self-locking member 300 abuts or is connected to the boss 224. Unlike the first embodiment, the elastic self-locking member 300 is abutted between the proximal end of the driving shaft 220 (abutting against the distal end of the driving shaft 220 in the first embodiment) and the step surface 2130, and the structure of the driving shaft 220 and the structure of the fixing base 210 are mutually adapted, so that the stability of the overall structure is facilitated.
Optionally, the proximal end of the drive shaft 220 is provided with an internally threaded section 225 that forms a threaded connection with the push shaft 2200.
Example III
Referring to fig. 27-30, a valve clamping device 1000 according to a third embodiment of the present invention has substantially the same structure as the first embodiment, and the clamp arm 110 is rotatably connected to the fixed base 210, except that a connecting arm 130 is provided between the clamp arm 110 and the fixed base 210, and when the driving shaft 220 moves relatively in the axial direction in the fixed base 210, the connecting arm 130 drives the clamp arm 110 to open or close with respect to the fixed base 210. Also different is the rotational connection of the jawarms 110 to the drive shaft 220.
Referring to fig. 31 to 33, the elastic self-locking member 300 is disposed at the outside of the driving shaft 220, and the proximal end surface of the elastic self-locking member 300 is welded to the fixing base 210 and the distal end surface is welded to the driving shaft 220, thereby elastically acting between the fixing base 210 and the driving shaft 220. In this embodiment, the elastic self-locking member 300 is an extension spring 310, and its initial state is a compressed state. When the drive shaft 220 is pushed distally, the spring 310 is stretched, the arms 110 of the valve clasping device 1000 open relative to the fixed base 210, and when the drive shaft 220 is retracted proximally, the spring 310 returns to its initial state of axial compression, the arms 110 of the valve clasping device 1000 close relative to the fixed base 210, thereby clamping the leaflet between the arms 110 and effecting locking of the arms 110 to the fixed base 210.
The structure of the embodiment has the advantages of (1) no need of complex self-locking mechanism, (2) self-adaptive flexible clamping force provided by the elastic self-locking piece 300, (3) lighter weight, simple operation and simple structure.
In summary, according to the structural differences of the valve clasper 1000, there are also large differences in the compression or extension deformation of the elastic self-locking member 300, i.e., the corresponding installation axial deformation and extreme compression axial deformation, or the installation axial deformation and extreme extension axial deformation, and different spring coefficient ranges can be selected according to the structural characteristics.
Claims (11)
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| CN111938870A (en) * | 2020-08-21 | 2020-11-17 | 杭州德晋医疗科技有限公司 | Valve clamping device with locking mechanism and valve repair system |
| CN212037832U (en) * | 2019-10-26 | 2020-12-01 | 北京航天卡迪技术开发研究所 | Unlockable mitral valve clip and delivery system |
| CN216439372U (en) * | 2020-12-31 | 2022-05-06 | 杭州德晋医疗科技有限公司 | Self-adaptive valve clamping device and valve clamping system |
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| US20100174363A1 (en) * | 2009-01-07 | 2010-07-08 | Endovalve, Inc. | One Piece Prosthetic Valve Support Structure and Related Assemblies |
| GB2536538B (en) * | 2014-09-17 | 2018-07-18 | Cardiomech As | Anchor for implantation in body tissue |
| CN110495972A (en) * | 2018-05-17 | 2019-11-26 | 杭州德晋医疗科技有限公司 | Valve clamping machine and valve clamping system |
| GB2579388B (en) * | 2018-11-29 | 2020-12-09 | Cardiomech As | Device for heart repair |
| CN211834508U (en) * | 2019-07-12 | 2020-11-03 | 杭州德晋医疗科技有限公司 | Valve clamping device easy to clamp and valve clamping system |
| CN211560531U (en) * | 2019-09-12 | 2020-09-25 | 杭州德晋医疗科技有限公司 | Anti-slip valve clamping device and valve clamping system |
| CN211723548U (en) * | 2019-10-30 | 2020-10-23 | 杭州德晋医疗科技有限公司 | Adjustable valve clamping system |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN212037832U (en) * | 2019-10-26 | 2020-12-01 | 北京航天卡迪技术开发研究所 | Unlockable mitral valve clip and delivery system |
| CN111938870A (en) * | 2020-08-21 | 2020-11-17 | 杭州德晋医疗科技有限公司 | Valve clamping device with locking mechanism and valve repair system |
| CN216439372U (en) * | 2020-12-31 | 2022-05-06 | 杭州德晋医疗科技有限公司 | Self-adaptive valve clamping device and valve clamping system |
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