CN112914794A - Pre-positioning device for an implantation instrument for cardiac surgery and surgical assembly - Google Patents

Pre-positioning device for an implantation instrument for cardiac surgery and surgical assembly Download PDF

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Publication number
CN112914794A
CN112914794A CN202110304390.1A CN202110304390A CN112914794A CN 112914794 A CN112914794 A CN 112914794A CN 202110304390 A CN202110304390 A CN 202110304390A CN 112914794 A CN112914794 A CN 112914794A
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CN
China
Prior art keywords
positioning device
implantation instrument
restraining
surgical assembly
positioning
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Pending
Application number
CN202110304390.1A
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Chinese (zh)
Inventor
吕世文
郑玲和
李毅斌
吴涛
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Ningbo Jenscare Biotechnology Co Ltd
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Ningbo Jenscare Biotechnology Co Ltd
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Priority to CN202110304390.1A priority Critical patent/CN112914794A/en
Publication of CN112914794A publication Critical patent/CN112914794A/en
Pending legal-status Critical Current

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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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial 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 relates to the field of medical instruments, in particular to a prepositioning device and a surgical assembly of an implantation instrument for cardiac surgery. The pre-positioning device comprises: a generally cylindrical body; wherein the pre-positioning device is in an incompletely radially expanded state before the implantation instrument reaches the expected release position of the cardiac procedure; and wherein the pre-positioning device expands to a fully radially expanded state substantially simultaneously with the implantation instrument after the implantation instrument has reached an intended release position for cardiac surgery.

Description

Pre-positioning device for an implantation instrument for cardiac surgery and surgical assembly
Technical Field
The invention relates to the field of medical instruments, in particular to a prepositioning device and a surgical assembly of an implantation instrument for cardiac surgery.
Background
At present, the aortic valve stent mainly comprises a mechanical expansion type stent, a balloon expansion type stent and a self-expansion type stent, the valve has small open area after the mechanical expansion type stent and the balloon expansion type stent are released, accurate positioning cannot be carried out, and the trans-valve pressure difference is large; although the cross-valve pressure difference is small and the conduction resistance is small after the self-expandable stent is released, the coaxiality is poor after the self-expandable stent is released, accurate positioning cannot be carried out, and the problems of valve perivalvular leakage, valve slippage and the like are easily caused. Most aortic valve stents are currently directed to aortic stenosis patients, and for aortic insufficiency patients, the problem of aortic valve stent fixation remains a technical problem in clinical practice.
Patent CN107468379A proposes an aortic valve stent delivery system, including the propelling movement release that is used for carrying aortic valve stent, dysmorphism sacculus pipe include the sacculus, and the sacculus has column connecting portion and the sacculus expansion portion that communicates with column connecting portion, and column connecting portion are connected with propelling movement release's front end, and the sacculus is designed as: after the expansion, a sacculus expansion portion be close to the side of column connecting portion form the locating surface, when using aortic valve support conveying system, the sacculus expansion portion of sacculus is located left ventricle outflow track and closely laminates through the bottom of locating surface with human aortic valve, plays the effect of location and reduction and/or prevention valve perivalvular leakage, but uses sacculus expansion support to fix a position the back, need retrieve the gasbag to the gasbag pressure release, the stability of the very easy secondary influence location structure of whole in-process.
Patent CN10896139A provides an implantable endoluminal prosthesis for replacing a damaged aortic valve. In one embodiment, the prosthesis comprises a balloon stent, a tubular catheter extending into the ascending aorta, and a self-expanding stent. The tubular conduit extends across the atlanto-expandable stent. The tubular catheter includes a prosthetic valve. The self-expanding stent extends over the tubular catheter into the ascending aorta. The balloon expandable stent, the tubular catheter and the self-expandable stent are connected together to provide one-way flow of fluid to the aorta and further to the coronary arteries, so that backflow can be inhibited, but the whole process adopts three ways of overlapping the balloon expandable stent, the self-expandable stent and the tubular catheter, which easily causes paravalvular leakage, in addition, the artificial valve leaflet is arranged on the tubular catheter, when the tubular catheter is positioned between the balloon expandable stent and the self-expandable stent and is in contact with the two stents, the expansion of the two stents can also cause the expansion of the tubular catheter, the stability of the release process of the artificial valve can be influenced, and accurate positioning can not be realized.
Patent WO2013012801 describes an interventional heart valve stent with polymeric sealing elements fixed inside or outside the bottom mesh, which can enter the space between the stent and the tissue annulus when the valve stent is released. In addition, if the compliance of the polymer sealing unit is insufficient, the irregular part of the tissue annular concave part cannot be filled, and the tissue annular convex part can oppress the valve support to influence the release process of the valve, so that the valve is leaked around the valve.
Patent CN201120022195.1 describes an ascending aorta endoluminal isolation graft with a filling type fixing ring, which comprises a tubular metal wire stent, an artificial blood vessel sutured or adhered to the inner side of the stent and a filling type fixing ring, wherein the filling type fixing ring comprises a spherical or ellipsoidal hollow ring wrapped outside the metal wire stent and a filling catheter used for filling a filler into the atlas, a filling type fixing bag is sutured or adhered to the outer side of the tectorial membrane straight-through stent, a water-absorbing material is arranged in the fixing bag and can absorb water to expand, aneurysm located in the ascending aorta can be effectively isolated, the occurrence of blood leakage or aneurysm rupture caused by the loosening and displacement of the graft in the blood vessel lumen is prevented, and the blood supply of the coronary artery, the head and arm trunk and other branch arteries is ensured, but the defects are that the water absorption rate cannot be effectively controlled, and the great potential safety hazard is caused by the leakage of some water-absorbing materials easily occurring in the fixing bag, endangering the life of the patient.
Therefore, how to realize accurate and firm positioning of the aortic valve stent, prevent paravalvular leakage and reduce the operation risk caused by subsequent operation becomes the problem which needs to be solved at present.
Disclosure of Invention
In view of the above and other, it is a primary object of the present invention to overcome the deficiencies of the prior art.
According to one embodiment of the application aspect of the aortic valve prosthesis, the invention can provide a prepositioning device of an implantation instrument for cardiac surgery for a patient with incomplete aortic valve leaflet closure and needing interventional therapy, thereby solving the problem that the aortic valve prosthesis cannot be accurately and stably positioned when being released, and reducing paravalvular leakage and central reflux.
According to an aspect of the present invention, there is provided a pre-positioning device for an implantation instrument for cardiac surgery, comprising: a generally cylindrical body; wherein the pre-positioning device is in an incompletely radially expanded state before the implantation instrument reaches the expected release position of the cardiac procedure; and wherein the pre-positioning device expands to a fully radially expanded state substantially simultaneously with the implantation instrument after the implantation instrument has reached an intended release position for cardiac surgery.
In one embodiment, the intended release location is a location of entry of the implantation instrument into the pre-positioning device.
In one embodiment, the implantation instrument includes a generally tubular stent that is fitted over the body of the pre-positioning device to form a laminate after cardiac surgery has been completed.
In one embodiment, the pre-positioning means comprises a stop lug provided on the outer surface of the body.
In one embodiment, the spacing protrusion is a circumferentially continuous protrusion.
In another embodiment, the spacing bump is at least two circumferentially discontinuous bump segments.
In one embodiment, the stop protrusion is integrally formed with the body.
In another embodiment, the stop lug is permanently affixed to the outer periphery of the body.
In another embodiment, the stopper protrusion is detachably coupled to the outer circumference of the body.
In one embodiment, the stop protrusion is sized to be substantially retained within a sinus of a heart vessel after completion of a cardiac procedure.
In one embodiment, the outer circumference of the stop protrusion has a radial dimension greater than the inner diameter of the native annulus of the heart.
In one embodiment, the pre-positioning device is provided with attachment means for attachment to an implantation instrument, the attachment means being selected from at least one of a step, barb, loop.
In one embodiment, the distal end of the pre-positioning device has a flared portion.
In one embodiment, the flared portion includes a configuration that forms an outer flange at the distal tip configured such that the outer flange substantially conforms to the contours of the patient's native tissue when the implantation instrument is installed in place within the patient.
In one embodiment, the outer flange ends are in an inwardly retracted state.
In one embodiment, the flared portion is configured such that the native valve leaflet of the patient is generally between the flared portion and the stop boss after the implantation instrument is installed in place within the pre-positioning device.
According to another aspect of the present invention, there is provided a surgical assembly for cardiac surgery, comprising: an inner tube; an outer sheath tube; the control handles are arranged at the near ends of the inner tube and the outer sheath tube; a pre-positioning device; and a constraining device detachably connected to the pre-positioning device, wherein the pre-positioning device is positioned between the inner tubing and the outer sheath and at the distal end portion of the inner tubing during the cardiac procedure before the implantation instrument reaches the desired release position for the cardiac procedure; and wherein the constraining means axially constrains the pre-positioning means when the control handle is operated to move the outer sheath proximally.
In one embodiment, the restraining device is a restraining wire.
In one embodiment, the proximal end of the pre-positioning means is provided with a ring-shaped structure which is detachably connected to the restriction means.
In one embodiment, the ring-shaped structure is integrally formed with the pre-positioning means.
In another embodiment, a plurality of groups of circumferential annular structures are arranged from the far end of the pre-positioning device to the near end of the pre-positioning device and are detachably connected with a plurality of limiting wires, the positions of the annular structures correspond to the positions of the limiting wires, the number of each group of circumferential annular structures is at least two, each group of circumferential annular structures are axially arranged at intervals, after the implantation instrument reaches an expected release position, radial restraint of each group of circumferential detachable connections on the pre-positioning device is gradually released from the far end of the pre-positioning device to the near end of the pre-positioning device, and the pre-positioning device is gradually radially expanded to a preset shape.
In another embodiment, the restraining means comprises a restraining wire and a plurality of perforations arranged from the distal end of the pre-positioning means to the proximal end of the pre-positioning means, the plurality of perforations being spirally distributed, one end of the restraining wire being adapted to be releasably arranged after passing through the plurality of perforations in sequence, the other end of the restraining wire being connected to the control handle, and after the implantation instrument has reached the desired release position, the control handle being operated to withdraw the one end of the releasing wire from the plurality of perforations in sequence to release the radial restraint on the pre-positioning means in a step-by-step manner, thereby causing the pre-positioning means to radially expand in a step-by-step manner to the pre-positioning means to the pre-set configuration, wherein a plurality of sets of restraining wires may.
In one embodiment, after releasing the restraining device, the proximal portion of the pre-positioning device, to which the restraining device is attached, grasps the native valve leaflets and against the surface of the pre-positioning device.
In one embodiment, the pre-positioning device does not have a pre-set shape at the proximal end portion, and the constraining device axially constrains the pre-positioning device when the control handle is operated to move the outer sheath proximally.
In one embodiment, the pre-positioning device is radially expanded by an external force.
In one embodiment, the surgical assembly further comprises a balloon catheter and an implantation instrument sleeved on the balloon catheter; and wherein the implantation instrument is released upon reaching the desired release position, thereby causing the pre-positioning device to radially expand.
In one embodiment, the pre-positioning means has a preset shape; wherein the constraining device provides axial and radial constraint of the pre-positioning device during cardiac surgery before the implantation instrument reaches the desired release position; and wherein, after the implantation instrument reaches the desired release position, the constraining means gradually releases the radial constraint on the pre-positioning means before and/or during release of the implantation instrument, causing the pre-positioning means to gradually radially expand to the pre-set shape.
In one embodiment, the restraining device includes a restraining wire and a restraining ring that fits over the restraining wire.
In one embodiment, the pre-positioning device has a self-expanding configuration.
According to another aspect of the present invention, there is also provided a pre-positioning device for an implantation instrument for cardiac surgery, comprising: a generally cylindrical body; and a stop protrusion disposed on an outer peripheral surface of the body, wherein the stop protrusion is sized to be substantially retained within a sinus of a heart vessel after a cardiac procedure is completed.
In one embodiment, the implantation instrument further comprises a prosthetic valve attached to the stent of the implantation instrument.
In one embodiment, the cardiac procedure is an aortic valve replacement procedure.
In another embodiment, the cardiac procedure is a pulmonary valve replacement procedure.
In one embodiment, the pre-positioning device is located at the distal end of the implantation instrument.
In another embodiment, the pre-positioning device is located at the proximal end of the insertion instrument.
In one embodiment, the pre-positioning device is positioned over the conductive fibers of the left ventricular septum after release of the implantation instrument into the pre-positioning device.
In one embodiment, where the implantation device is a balloon expandable stent, the balloon is made of a semi-compliant material, preferably a nylon material.
In one embodiment, the pre-positioning device and the surface of the implant device are covered with a membrane, preferably polytetrafluoroethylene.
In one embodiment, the pre-positioning device and the implantation instrument are provided with visualization indicia or other visualization means for displaying the position and orientation of the pre-positioning device and the implantation instrument in the aorta.
Compared with the prior art, the advantages of the invention at least comprise the following:
1. the traditional stent with the valve has to be precisely positioned at a specific position of the virtual valve ring, but the specific positioning position is difficult to obtain in the actual operation process, the operation time is prolonged, and some postoperative complications are caused. Different from the prior art, the pre-positioning device can be released preferentially before the implantation instrument is released, and the pre-positioning device is designed according to the shape of the valve and comprises a main body which is substantially cylindrical and is matched with the physiological structure of the heart, so that perivalvular leakage is reduced; secondly, before the implantation instrument reaches the expected release position of the cardiac surgery, on one hand, the pre-positioning device is in an incomplete radial expansion state, so that the pre-positioning device has a small diameter and does not influence the normal work of the autologous valve in the cardiac surgery process, and on the other hand, the pre-positioning device can provide a pre-positioning effect for the implantation instrument, so that the release position of the implantation instrument does not need to be accurately positioned by means of an autologous physiological anatomical structure, the positioning difficulty of the implantation instrument is reduced, the operation is simple and convenient, and negative effects are not caused; thirdly, after the implantation instrument reaches the expected release position of the heart operation, the prepositioning device and the implantation instrument are expanded to a completely radial expansion state at the same time, so that the autologous valve can be ensured to be still in a normal working state in the process, and the blood flow is prevented from being interrupted; finally, even if the patient's large annulus is calcified too severely, the implantation instrument can still be placed in the optimal position by preferentially releasing the pre-positioning device for positioning before releasing the implantation instrument.
2. Different from the prior art, the implantation instrument in one embodiment of the invention comprises a generally tubular stent, and the stent is sleeved in the main body of the prepositioning device to form a laminated structure after the heart operation is completed, so that the process requirement is reduced, the implantation instrument is ensured to obtain a sufficient expansion or self-expansion molding area, and the central reflux is reduced or prevented on the premise of ensuring that the normal operation of the artificial valve leaflet is not influenced.
3. Different from the prior art, the limiting bulge in one embodiment of the invention is sized to be substantially kept in the sinus of a heart vessel after the heart operation is completed, the radial size of the periphery of the limiting bulge is larger than the inner diameter of the self-body valve ring of the heart, and the limiting bulge can provide support for the prepositioning device, prevent the artificial valve from shifting, and relieve the valve ring from bearing the radial outward expansion force from the prepositioning device and an implanting apparatus, so that the self-body valve ring can be prevented from further expanding, the valve can be prevented from being torn, and the valve leakage can be reduced.
4. Different from the prior art, in one embodiment of the invention, the pre-positioning device is provided with a connecting mechanism for connecting with an implantation instrument, and the connecting mechanism is selected from at least one of a step, a barb and a ring, so that the binding force between two layers of supports can be increased, the stability of the structural design is improved, and the valve leakage is prevented.
5. Different from the prior art, the outer flange in one embodiment of the invention is generally fit with the autologous tissue profile of the patient, the autologous valve leaflet of the patient is approximately positioned between the flaring part and the limiting bulge, the perivalvular leakage is effectively prevented, and in addition, the tail end of the outer flange is in an inward folding state, so that the autologous tissue can be prevented from being scratched.
6. Different from the prior art, in one embodiment of the invention, when the pre-positioning device is axially constrained by the constraining device or the constraining device provides axial and radial constraint for the pre-positioning device during the cardiac operation before the implantation instrument reaches the expected release position, on one hand, the pre-positioning device can be prevented from being displaced to the left ventricular outflow tract, and on the other hand, the self-valve operation can be prevented from being influenced after the pre-positioning device is released, so that the blood flow is prevented from being interrupted.
7. In contrast to the prior art, in one embodiment of the invention, when the pre-positioning device has a pre-set shape, after the implantation instrument has reached the desired release position, the constraining device gradually releases the radial constraint on the pre-positioning device before and/or during release of the implantation instrument, causing the pre-positioning device to gradually expand radially to the pre-set shape, thereby ensuring that the pre-positioning device and the implantation instrument expand substantially simultaneously to a fully radially expanded state.
8. Different from the prior art, in one embodiment of the invention, after the restraining device is released, the proximal end portion of the pre-positioning device connected with the restraining device clamps the autologous valve leaflets and abuts against the surface of the pre-positioning device, so that the valve leaflet clamping effect is achieved, on one hand, the support force can be provided for the pre-positioning device, and on the other hand, the autologous valve leaflets can be prevented from blocking the coronary arteries.
Drawings
Fig. 1a to 1c are internal layout views of a conveying system according to an embodiment of the present invention.
FIG. 2a is a schematic diagram of a pre-positioning device according to various embodiments of the present invention
FIGS. 2a 2c are schematic views showing the released balloon expandable stent in accordance with one embodiment of the present invention.
Fig. 3 a-3 b are schematic views illustrating the process of delivering the delivery system to the aortic valve lesion in various embodiments of the present invention.
Fig. 4a to 4d are schematic diagrams illustrating a process of entering a target position by a pre-positioning device according to an embodiment of the present invention.
FIGS. 5 a-5 b are schematic views illustrating a process for releasing a balloon expandable stent according to an embodiment of the present invention.
FIGS. 6 a-6 c are schematic views illustrating the withdrawal of the delivery system from the heart, in accordance with one embodiment of the present invention.
FIGS. 7 a-7 c are schematic views of a delivery system and a prosthetic valve stent according to a second embodiment of the present invention.
FIGS. 8 a-8 f are schematic diagrams illustrating the release of the pre-positioning device and the release of the prosthetic valve stent according to a second embodiment of the present invention.
FIGS. 9 a-9 b are schematic views illustrating the withdrawal of the heart by the delivery system in accordance with a second embodiment of the present invention.
The names of the parts indicated by the numbers in the drawings are as follows: 1-prepositioning device, 11-limiting bulge, 12-flaring part, 13-connecting mechanism, 14-main body, 2-balloon expandable stent, 21-balloon, 22-balloon catheter, 3-control handle, 4-outer sheath tube, 5-inner tube, 6-inner core tube, 61-control release device, 62-middle lumen tube, 63-transmission tube, 64-connecting device, 7-restraining device, 71-limiting ring, 72-limiting wire, 8-annular structure, 81-controlling wire and 9-artificial valve stent.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings and examples.
In the present invention, the proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator.
The first embodiment is as follows:
in the embodiment, taking aortic valvular disease treatment as an example, a prepositioning device of an implantation instrument for cardiac surgery, the prepositioning device 1 comprises a main body 14 which is substantially cylindrical, the cardiac surgery comprises a surgery component, the surgery component comprises a conveying system, as shown in fig. 1a to 1c, the conveying system comprises a control handle 3, an outer sheath tube 4, an inner tube 5, an inner core tube 6 and a control release device 61, the implantation instrument is a balloon expansion bracket 2, the inner core tube 6 is connected with the control release device 61, the prepositioning device 1 is positioned between the inner tube 5 and the outer sheath tube 4 and at the distal end part of the inner tube 5, the proximal end of the prepositioning device 1 and the distal end of the control release device 61 are detachably connected through a control wire, a balloon catheter 22 is arranged between the inner tube 5 and the inner core tube 6, the balloon catheter 22 comprises a balloon 21, the balloon expansion, the saccule expansion bracket 2 is positioned at the proximal end of the prepositioning device 1, the operation is provided with a limiting wire 72 which is detachably connected with the prepositioning device 1, the control handle 3 is operated to enable the outer sheath tube 4 to move towards the proximal end, the limiting wire 72 axially restrains the prepositioning device 1 before the saccule expansion bracket 2 reaches the expected release position, the prepositioning device 1 is in the state of incomplete radial expansion, as shown in figures 4 b-4 c, the prepositioning device 1 can be prevented from shifting to the left ventricular outflow tract, the outer surface of the main body 14 is provided with a limiting bulge 11, after the saccule expansion bracket 2 reaches the expected release position of the heart operation by operating the control handle 3, the saccule expansion bracket 2 is released, the prepositioning device 1 and the saccule expansion bracket 2 are expanded to the state of complete radial expansion in size at the same time, the limiting bulge 11 is arranged to be capable of being, as shown in fig. 5 a-5 b, the radial dimension of the periphery of the limiting protrusion 11 is greater than the inner diameter of the self-body valve ring of the heart, the limiting protrusion 11 can provide support for the pre-positioning device 1, prevent the artificial valve from shifting, and reduce the radial expansion force of the aortic valve ring from the pre-positioning device 1 and the balloon expansion support 2, so as to prevent the self-body valve ring from further expanding, prevent the valve from tearing and reduce the leakage around the valve, the balloon expansion support 2 comprises a substantially tubular support, the support is sleeved in the main body 14 of the pre-positioning device 1 after the heart operation is completed to form a laminated structure, thereby reducing the process requirements, ensuring that the balloon expansion support 2 obtains sufficient expansion or self-expansion molding area, and reducing or preventing the central reflux on the premise of not affecting the normal operation of the artificial valve leaflet.
The components and connections of the present embodiment will be described in detail below with reference to the accompanying drawings:
in this embodiment, as shown in fig. 2a, a connection mechanism 13 is provided in the pre-positioning device 1 and is used for being connected to the balloon expandable stent 2, and the connection mechanism 13 is a step, so that the bonding force between two layers of stents can be increased, the stability of the structural design is improved, and the valve leakage is prevented.
In this embodiment, the distal end of the pre-positioning device 1 has a flared portion 12, as shown in fig. 2a and 2c, which includes a configuration that forms an outer flange at the distal tip, configured such that when the balloon expandable stent 2 is installed in place in the patient, the outer flange substantially conforms to the contour of the patient's native tissue, effectively preventing paravalvular leakage.
In this embodiment, the end of the outer flange is in an inward-folded state, which can prevent the autologous tissue from being scratched.
In the present embodiment, as shown in fig. 2c, the flared portion 12 is configured such that when the balloon-expandable stent 2 is mounted in place within the pre-positioning device 1, the native leaflets of the patient are generally between the flared portion 12 and the stop protrusions 11.
In this embodiment, the proximal end of the pre-positioning device 1 is provided with two annular structures 8 detachably connected to the limiting wire 72, the annular structures 8 are integrally formed with the pre-positioning device 1, as shown in fig. 2c, after the limiting wire 72 is released, the proximal end portion of the pre-positioning device 1 connected to the limiting wire 72 clamps the autologous leaflets and abuts against the surface of the pre-positioning device 1, so that the leaflet clamping effect is achieved, on one hand, a supporting force can be provided for the pre-positioning device, and on the other hand, the autologous leaflets can be prevented from blocking the coronary artery.
In this embodiment, the pre-positioning device 1 does not have a pre-set shape, and the restraining wire 72 axially restrains the pre-positioning device 1 during heart surgery before the balloon-expandable stent 2 reaches the desired release position.
In this embodiment, the pre-positioning device 2 is radially expanded by an external force.
In this embodiment, the balloon-expandable stent 2 is released after reaching the desired release position, thereby causing the pre-positioning device 1 to radially expand.
In this embodiment, the surface of the limiting protrusion 11 is smooth and can prevent the vessel wall from being scratched, the limiting protrusion is three discontinuous protrusions, and the limiting protrusion 11 and the main body 14 are integrally formed.
In the embodiment, after the saccule expansion bracket 2 enters the pre-positioning device 1 and is released, the pre-positioning device 1 is positioned above the conducting fibers of the left ventricular septum, so that the left bundle branch conducting passage can be prevented from being interfered, and the nerve electrical signal conduction can be prevented from being influenced.
In this embodiment, the balloon expandable stent 2 further comprises a prosthetic valve.
The operation procedure of the present embodiment in the operation is as follows:
(1) the control handle 3 is operated, the balloon-expandable stent 2 and the surgical component are guided into the aorta through the femoral minimally invasive orifice by retrograde puncture through the guide wire, and the balloon-expandable stent 2 and the surgical component bend and cross the aortic arch to reach the ascending aorta and enter the aortic valve lesion position, as shown in fig. 3a and 3 b.
(2) After the control handle 3 is operated to move the sheath 4 proximally (as shown in fig. 4 a), the limiting wire 72 axially restrains the pre-positioning device 1, and after the delivery system is retracted to a position where the limiting protrusion 11 is located on the aortic sinus, the control handle 3 is operated to disengage the control release device 61 from the proximal end of the pre-positioning device 1, as shown in fig. 4b and 4 c.
(3) After continuing to operate the control handle 3 so that the balloon-expandable stent 2 reaches the desired release position for the cardiac procedure, as shown in fig. 4d, while expanding the balloon 21 and withdrawing the core tube 6, the balloon-expandable stent 2 is passively expanded to release, the pre-positioning device 1 is expanded substantially simultaneously with the balloon-expandable stent 2 to a fully radially expanded state until the stop lobes 11 are sized to substantially remain within the sinuses of the heart vessel after the cardiac procedure is completed, as shown in fig. 5a and 5 b.
(4) The balloon 21 is deflated, the restraining wire 72 is released, the delivery system is withdrawn on the way, and the surgical procedure is completed, as shown in fig. 6 a-6 c.
Example two:
in this embodiment, taking aortic valve disease treatment as an example, a pre-positioning device of an implantation apparatus for cardiac surgery, the cardiac surgery includes a surgical assembly, the surgical assembly includes a delivery system, as shown in fig. 7a and 7b, the pre-positioning device includes a substantially cylindrical main body 14, the delivery system includes a control handle 3, an outer sheath tube 4, a middle lumen tube 62, an inner tube 5, a transmission tube 63 and a connecting device 64, the middle lumen tube 62 is located between the inner tube 5 and the outer sheath tube 4, a prosthetic valve support 9 is arranged between the inner tube 5 and the middle lumen tube 62, the distal end of the connecting device 64 is detachably connected with the proximal end of the prosthetic valve support 9, the distal end portion of the inner tube 5 is provided with a pre-positioning device 1, the prosthetic valve support 9 is located at the proximal end of the pre-positioning device 1, the proximal end of the pre-positioning device 1 and the distal end of the prosthetic valve support 9 are detachably, the operation assembly is provided with a restraining device 7 which is detachably connected with the pre-positioning device 1, the restraining device 7 comprises a restraining wire 71 and a restraining ring 72, as shown in figures 8d and 8e, when in preassembly, the pre-positioning device 1 is positioned between the inner tube 4 and the outer sheath tube 5, before the artificial valve stent 9 reaches the expected release position, the restraining device 7 provides axial and radial restraint for the pre-positioning device 1, on one hand, the pre-positioning device 1 can be prevented from being displaced to the left ventricular outflow tract, on the other hand, the self-valve work can be prevented from being influenced after the pre-positioning device 1 is released, the blood flow is prevented from being interrupted, the pre-positioning device has a preset shape, before the artificial valve stent 9 reaches the expected release position of the heart operation, the pre-positioning device 1 is in an incomplete radial expansion state, as shown in figures 8 a-8 d, after the, the restraining means 7 progressively releases the radial restraint of the pre-positioning means 1 before and/or during release of the prosthetic valve stent 9, the pre-positioning means 1 expanding to a fully radially expanded state substantially simultaneously with the prosthetic valve stent until the retention bumps 11 are sized to remain substantially within the sinuses of the heart vessel after completion of the heart procedure (as shown in figures 8 e-8 f).
The components and connections of the present embodiment will be described in detail below with reference to the accompanying drawings:
in this embodiment, a connection mechanism 13 is disposed in the pre-positioning device 1 for connecting with an implantation instrument, and the connection mechanism is a step.
In this embodiment, as shown in FIG. 7c, the distal end of the pre-positioning device 1 has a flared portion 12, and the flared portion 12 includes a configuration that forms an outer flange at the distal end, which is configured such that the outer flange substantially conforms to the contours of the patient's native tissue when the prosthetic valve holder 9 is installed in place within the patient.
In this embodiment, the end of the outer flange is in an inward-folded state, which can prevent the autologous tissue from being scratched.
In the present embodiment, as shown in fig. 9a to 9b, the flared portion 12 is configured such that the native valve leaflet of the patient is substantially between the flared portion 12 and the stop protrusion 11 after the prosthetic valve holder 9 is mounted in place in the pre-positioning device 1.
In this embodiment, the proximal end of the pre-positioning device 1 is provided with two annular structures 8 detachably connected with the limiting wire 72, the annular structures 8 and the pre-positioning device 1 are integrally formed, and when the limiting wire 72 is released, the proximal part of the pre-positioning device 1 connected with the limiting wire 72 clamps the autologous valve leaflet and clings to the surface of the pre-positioning device 1 (as shown in fig. 7 c).
In this embodiment, the pre-positioning device 1 has a predetermined shape; and the constraining means provide axial and radial constraint of the pre-positioning means during the heart operation, before the stent-prosthesis 9 reaches the desired release position; and wherein, after the prosthetic valve stent 9 has reached the intended release position, the constraining means 7 gradually releases the radial constraint on the pre-positioning means 1 before and/or during release of the prosthetic valve stent, causing the pre-positioning means 1 to gradually expand radially to the pre-set shape.
In this embodiment, the surface of the limiting protrusion 11 is smooth and can prevent the vessel wall from being scratched, the limiting protrusion is three discontinuous protrusions, and the limiting protrusion 11 and the main body 14 are integrally formed.
In this embodiment, the radial dimension of the outer circumference of the stop protrusion 11 is larger than the inner diameter of the native annulus of the heart.
In this embodiment, the pre-positioning device 1 has a radially self-expanding configuration.
In this embodiment, the prosthetic valve is attached to a prosthetic valve holder 9.
In this embodiment, after the prosthetic valve stent 9 is released after entering the pre-positioning device 1, the pre-positioning device 1 is located above the conductive fibers of the left ventricular septum, so that the left bundle branch conductive pathway can be prevented from being interfered, and the nerve electrical signal conduction can be prevented from being influenced.
The operation procedure of the present embodiment in the operation is as follows:
(1) the control handle 3 is operated, the implantation instrument and the operation component are guided into the aorta through the femoral minimally invasive orifice by reverse puncture through the guide wire, and the implantation instrument and the operation component span the aortic arch to reach the ascending aorta after bending adjustment and enter the aortic valve lesion position as shown in fig. 3a and 3 b.
(2) The control handle 3 is operated to move the sheath 4 proximally (as shown in fig. 8 a), the prepositioning device 1 returns to the preset shape, the constraining device 7 provides axial and radial constraint for the prepositioning device 1, and after the delivery system is withdrawn until the limiting protrusion 11 is positioned on the aortic sinus, the control handle 3 is operated to release the control wire 81 between the proximal end of the prepositioning device 1 and the distal end of the artificial valve stent 9, as shown in fig. 8b and 8 c.
(3) The control handle 3 is operated to move the prosthetic valve stent 9 into the pre-positioning device 1 and to move the middle lumen 62 proximally, as shown in fig. 8d, the prosthetic valve stent 9 is released to return to the preset shape, the detachable connection between the proximal end of the prosthetic valve stent 9 and the connecting device 64 is released, the control handle 3 is operated to move the restriction ring 71 proximally, whereupon the proximal end of the pre-positioning device 1 gradually returns to the preset shape, the pre-positioning device 1 and the prosthetic valve stent 9 expand substantially simultaneously to a fully radially expanded state until the restriction protrusion 11 is sized to substantially remain in the sinus of the heart vessel after the heart operation is completed, as shown in fig. 8 e.
(4) The restraining wire 72 between the loop 8 and the delivery system is released, as shown in figure 8e, and the delivery system is withdrawn in the way to complete the procedure, as shown in figures 9a and 9 b.
The foregoing is only an exemplary embodiment of the present invention, and those skilled in the art can change the invention in its specific embodiments and application scope according to the spirit of the present invention, and the present disclosure should not be construed as limiting the invention.

Claims (23)

1. A pre-positioning device for an implantation instrument for cardiac surgery, comprising:
a generally cylindrical body;
wherein the pre-positioning device is in a state of incomplete radial expansion before the implantation instrument reaches an intended release position of the cardiac procedure; and is
Wherein the pre-positioning device expands to a fully radially expanded state substantially simultaneously with the implantation instrument after the implantation instrument reaches an intended release position of the cardiac procedure.
2. The pre-positioning device of claim 1, wherein the implantation instrument includes a generally tubular stent that is fitted over the body of the pre-positioning device to form a laminate after completion of the cardiac procedure.
3. The pre-positioning device according to any one of the preceding claims, wherein the pre-positioning device comprises a limiting protrusion arranged on the outer surface of the main body.
4. The pre-positioning device of claim 3, wherein the stop protrusion is selected from one of:
a circumferentially continuous protrusion; and
at least two circumferentially discontinuous convex segments.
5. The pre-positioning device of any one of claims 3-4,
the limiting bulge and the main body are integrally formed; or
The limiting protrusion is permanently fixed or detachably connected to the periphery of the main body.
6. The pre-positioning device of any of claims 3-5, wherein the stop bumps are sized to be substantially retained within a sinus of a heart vessel after the cardiac procedure is completed.
7. The pre-positioning device according to any one of claims 3-6, wherein the outer circumference of the stop protrusion has a radial dimension greater than the inner diameter of the native annulus of the heart.
8. The pre-positioning device according to any one of the preceding claims, wherein the pre-positioning device is provided with attachment means for attachment to the implantation instrument, the attachment means being selected from at least one of a step, a barb, and a loop.
9. The pre-positioning device according to any one of the preceding claims, wherein a distal end of the pre-positioning device has a flared portion.
10. The pre-positioning device of claim 9, wherein the flared portion includes a configuration that forms an outer flange at a distal tip configured such that the outer flange substantially conforms to the patient's native tissue contour when the implantation instrument is installed in place within the patient.
11. The pre-positioning device of claim 9 or 10, wherein the flared portion is configured such that the patient's native leaflets are generally between the flared portion and the stop ledges after the implantation instrument is installed in place within the pre-positioning device.
12. A surgical assembly for cardiac surgery, comprising:
an inner tube;
an outer sheath tube;
a control handle disposed at a proximal end of the inner tube and the outer sheath;
the pre-positioning device according to any one of claims 1-11; and
a restriction device detachably connected to the pre-positioning device,
wherein, during the cardiac procedure, the pre-positioning device is positioned between the inner tubing and the outer sheath and at the distal end portion of the inner tubing before the implantation instrument reaches an intended release position of the cardiac procedure; and is
Wherein the constraining means axially constrains the pre-positioning means when the control handle is operated to move the outer sheath proximally.
13. The surgical assembly according to claim 12, wherein the restraining device is a restraining wire.
14. The surgical assembly according to claim 12 or 13, wherein the proximal end of the pre-positioning device is provided with a ring-shaped structure that is detachably connected with the restraining device.
15. The surgical assembly according to claim 14, wherein the ring-shaped structure is integrally formed with the pre-positioning device.
16. The surgical assembly according to any one of claims 12-15, wherein upon release of the restraining device, a proximal portion of the pre-positioning device coupled to the restraining device grips the native valve leaflets and rests against a surface of the pre-positioning device.
17. The surgical assembly according to any one of claims 12-16, wherein the pre-positioning device does not have a preset shape at a proximal end portion, the restraining device axially restraining the pre-positioning device during the cardiac procedure before the implantation instrument reaches the intended release position.
18. The surgical assembly according to claim 17, wherein the pre-positioning device is radially expanded by an external force.
19. The surgical assembly according to claim 17 or 18, wherein the surgical assembly further includes a balloon catheter and an implantation instrument fitted over the balloon catheter; and is
Wherein the implantation instrument is released upon reaching the desired release location, thereby causing radial expansion of the pre-positioning device.
20. The surgical assembly according to any one of claims 12-16, wherein the pre-positioning device has a pre-set shape;
wherein the constraining device provides axial and radial constraint of the pre-positioning device during the cardiac procedure prior to the implantation instrument reaching the intended release position; and is
Wherein, after the implantation instrument reaches the desired release position, the constraining device gradually releases the radial constraint on the pre-positioning device before and/or during release of the implantation instrument to gradually radially expand the pre-positioning device to the preset shape.
21. The surgical assembly according to claim 20, wherein the restraining device includes a restraining wire and a restraining ring that fits over the restraining wire.
22. The surgical assembly according to any one of claims 20-21, wherein the pre-positioning device has a self-expanding configuration.
23. A pre-positioning device for an implantation instrument for cardiac surgery, comprising:
a generally cylindrical body; and
a limit bulge arranged on the outer circumferential surface of the main body,
wherein the stop protrusion is sized to be substantially retained within a sinus of a heart vessel after completion of the cardiac procedure.
CN202110304390.1A 2021-03-22 2021-03-22 Pre-positioning device for an implantation instrument for cardiac surgery and surgical assembly Pending CN112914794A (en)

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Application Number Priority Date Filing Date Title
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113558827A (en) * 2021-08-27 2021-10-29 宁波健世科技股份有限公司 Device for controlling release of implantation instrument

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113558827A (en) * 2021-08-27 2021-10-29 宁波健世科技股份有限公司 Device for controlling release of implantation instrument

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