[go: up one dir, main page]

WO2025080729A1 - Appareil de pose avec dispositif de perforation - Google Patents

Appareil de pose avec dispositif de perforation Download PDF

Info

Publication number
WO2025080729A1
WO2025080729A1 PCT/US2024/050592 US2024050592W WO2025080729A1 WO 2025080729 A1 WO2025080729 A1 WO 2025080729A1 US 2024050592 W US2024050592 W US 2024050592W WO 2025080729 A1 WO2025080729 A1 WO 2025080729A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrically conductive
nosecone
examples
valve
prosthetic valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/050592
Other languages
English (en)
Inventor
Ofir Witzman
Eitan ATIAS
Peleg HAREL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025080729A1 publication Critical patent/WO2025080729A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • 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
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22097—Valve removal in veins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00166—Multiple lumina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00369—Heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/0038—Foramen ovale
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Definitions

  • a delivery assembly comprising a delivery apparatus.
  • the delivery apparatus comprises an electrically conductive surface at a distal end of the nosecone.
  • the delivery apparatus comprises an electric current source electrically coupled to the electrically conductive surface and configured to provide electric current to the electrically conductive surface.
  • the electrically conductive surface extends from the distal end of the nosecone.
  • the method comprises actuating the electrically conductive surface by providing an electric current to the electrically conductive surface.
  • the electrically conductive surface extends from the distal end of the nosecone.
  • the electrically conductive surface is shaped as a portion of a circle. [0022] In some examples, the electrically conductive surface is coupled to the electric current source via an electrically conductive material. In some examples, the electrically conductive material constitutes at least a portion of a guidewire. In some examples, the electrically conductive material constitutes a least a portion of the nosecone shaft.
  • FIG. 4 shows an exemplary perforation device, according to some examples of the present disclosure.
  • Fig. 7 shows a perspective view an exemplary delivery assembly, according to some examples of the disclosure.
  • Fig. 8 shows a cross-sectional view of a portion of the delivery assembly of Fig. 7.
  • integrally formed and unitary construction refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.
  • the expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state.
  • a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.
  • a prosthetic valve of the current disclosure (for example, prosthetic valve 100) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.
  • Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus (not shown).
  • Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve.
  • Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion.
  • the mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US2021/052745 and U.S. Provisional Application Nos. 63/085,947 and 63/209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter.
  • expansion and locking assemblies such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US2021/052745 and U.S. Provisional Application Nos. 63/085,947 and 63/209904, each of which is incorporated herein by reference in its entirety
  • inflow refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100.
  • lower and upper are used interchangeably with the terms “inflow” and “outflow”, respectively.
  • the lower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.
  • the prosthetic valve 100 comprises an annular frame 102 movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure 113 that comprises prosthetic valve leaflets 114 mounted within the frame 102.
  • the frame 102 can be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel based alloy (for example, a cobalt-chromium or a nickel- cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof.
  • the frame 102 can be crimped to a radially compressed state on a balloon catheter, and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism.
  • the frame 102 is an annular, stent-like structure comprising a plurality of intersecting struts 108.
  • strut encompasses axial struts, angled struts, laterally extendable struts, commissure windows, commissure support struts, support posts, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference.
  • a strut 108 may be any elongated member or portion of the frame 102.
  • the frame 102 can include a plurality of strut rungs that can collectively define one or more rows of cells 110.
  • a valvular structure 113 of the prosthetic valve 100 can include a plurality of prosthetic valve leaflets 114 (for example, three leaflets), positioned at least partially within the frame 102, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 106. While three leaflets 114 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Figs. 2A-2B, it will be clear that a prosthetic valve 100 can include any other number of leaflets 114.
  • the prosthetic valve 100 can comprise, in some examples, an outer skirt 118 mounted on the outer surface of frame 102 (as shown in Figs.
  • a new prosthetic heart valve is mounted within the existing, degrading prosthetic heart valve in order to restore proper function.
  • Fig. 3 illustrates an exemplary hypothetical coronary artery obstruction that could occur in some cases from implantation of a prosthetic valve 100b within a previously implanted prosthetic valve 100a (for example, after a ViV procedure).
  • the prosthetic valve 100b is the guest valve or new valve
  • the prosthetic valve 100a is the host valve or old valve.
  • Any delivery apparatus described throughout the current disclosure is advantageously configured to modify the host valvular structure 12 (for example, modify at least one of the host leaflets 10), and implant a guest prosthetic valve 100 within the modified valvular structure, without the need to switch between separate delivery apparatuses for each function.
  • an electrically insulated portion 238 of the perforation device 235 extends between the ends of the electrically conductive portion 236 of the perforation device 235.
  • the combined shape of the electrically insulated portion 238 and the perforation device 235 define a full circle.
  • the electrically insulated portion 238 has a circumferential length L2, such that the combination of circumferential lengths LI and L2 is equal to the circumference of the circle defined by the perforation device 235 and the electrically insulated portion 238.
  • the perforation device 235 comprises an electrode, where the electrically insulated portion 238 comprises an electrically insulating layer of material covering the respective section of the electrode.
  • the perforation device 235 is illustrated in FIG. 6B as comprising electrically insulated portion 238, this is not meant to be limiting in way. According to some examples (not shown), the perforation device 235 defines a geometrically open shape, such as a portion of a circle, and the open ends of the perforation device 235 have an empty space therebetween.
  • the handle 204 can further include an adjustment mechanism including an adjustment member, such as the illustrated rotatable knob 206b.
  • the handle can include additional adjustment mechanisms controllable by additional knobs to maneuver additional components of the delivery apparatus 202, such as axial movement of other components and/or shafts of a cutting device and/or prosthetic valve deployment assemblies that extend from the delivery apparatus 202.
  • Figs. 4C and 4D are illustrated in relation to examples where the perforation device 235 is coupled to the electric current source 205 by a wire, this is not meant to be limiting in any way.
  • the electrically conductive material 237 constitutes a respective portion of the nosecone shaft 203.
  • the guidewire 230 is part of the delivery apparatus 202 and the electrically conductive material 237 constitutes at least a portion of the guidewire 230.
  • the electric current source 205 generates an electric current, and outputs the generated electric current to the perforation device 235.
  • the generated electric current is an alternating current.
  • the frequency of the alternating current is a radio-frequency (RF) (for example, between about 20 kHz and 300 GHz).
  • the perforation device 235 conducts electricity from the electrically conductive portion 236.
  • the electrically conductive portion 236 of the perforation device 235 is configured to output RF energy.
  • the electric current can be controlled to be generated only when the perforation device 235 is present at the desired location. Thus, accidental perforation of other tissue can be avoided.
  • tissue opening 52 which can be a leaflet opening 52 when the target tissue is a host leaflet 10, as shown in Figs. 5C - 5D.
  • the nosecone 220 is distally advanced through the perforation 225, as will be further described below.
  • the nosecone 220 has a tapering distal portion, that can taper from the proximal end thereof to a smaller diameter in the distal direction.
  • the maximal diameter of the nosecone 220 is greater than the diameter of the perforation 225 formed by the perforation device 235, advancement of the nosecone 220 through the leaflet opening 52 formed by perforation 225 can serve to further dilate the leaflet opening 52.
  • the delivery assembly 200 can be packaged in a sterile package that can be supplied to end users for storage and eventual use.
  • the leaflets of the prosthetic valve (typically made from bovine pericardium tissue or other natural or synthetic tissues) are treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the delivery assembly can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.
  • the balloon catheter 210 is shown to terminate at a proximal end of the balloon 240 in in some examples, the balloon catheter 210 can extend farther in the distal direction (examples not illustrated), through a portion or through the entire length of the balloon cavity 243, and one or more of the balloon catheter opening(s) 214 can be formed on the sidewall of the balloon catheter 210, exposed laterally to the balloon cavity 243.
  • the proximal ends of the catheter 210, the outer delivery shaft 208, the push shaft 228, and optionally the nosecone shaft 203 are coupled to the handle 204.
  • the handle 204 is maneuvered by an operator (for example, a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 202, such as the nosecone shaft 203, the catheter 210, the outer delivery shaft 208, the push shaft 228, and the guidewire 230, through the patient's vasculature and/or along the target site of implantation, as well as to inflate the balloon 240 mounted on the catheter 210, so as to expand the prosthetic valve 100, and to deflate the balloon 240 and retract the delivery apparatus 202 once the prosthetic valve 100 is mounted in the implantation site (for example, within the host valve).
  • the prosthetic valve 100 is carried by the delivery apparatus 202 during delivery in a crimped state, and expanded by balloon inflation to secure it in a native heart valve annulus (such as aortic annulus 24) or against a previously implanted prosthetic valve.
  • the prosthetic valve 100 is initially crimped over the catheter 210, proximal to the inflatable balloon 240. Because prosthetic valve 100 is crimped at a location different from the location of balloon 240, prosthetic valve 100 can be crimped to a lower profile than would be possible if it was crimped on top of balloon 240.
  • the balloon 240 is secured to balloon catheter 210 at the balloon's proximal end, and to either the balloon catheter 210, the nosecone shaft 203 or the nosecone 220 at its distal end.
  • the distal end portion of the push shaft 228 is positioned proximal to the outflow end of the prosthetic valve 100.
  • delivery assembly 200 is described herein as carrying a prosthetic valve, this is not meant to be limiting in any way and the delivery assembly 200 and delivery assembly 200 can be used for implantation of other prosthetic devices aside from prosthetic valves, such as stents or grafts.
  • the deflated balloon 240 and the prosthetic valve 100 disposed thereover can be then advanced and positioned within the leaflet opening 52, as shown in Fig. 9C.
  • the push shaft 216 can remain in position, abutting the outflow end 106 of the prosthetic valve 100 during advancement into and through the leaflet opening 52, to provide a counter force that resists proximal displacement of the prosthetic valve 100 during insertion into the leaflet opening 52.
  • radially expanding the guest prosthetic valve can serve to increase a size of the leaflet opening 52 and/or to tear the leaflet.
  • radially expanding the guest prosthetic valve 100 can serve to modify the host leaflet 10 such that the leaflet does not obstruct a cell opening 112 in a frame 102 of the guest prosthetic valve 100 or at least increases the area of the host valve and the guest valve that is not covered or obstructed by the modified host leaflet to permit access and sufficient perfusion to the adjacent coronary artery.
  • radially expanding the guest prosthetic valve within the leaflet opening 52 can operate to push a portion of the leaflet extending radially exterior of the guest prosthetic valve below an upper edge of an outer skirt of the guest prosthetic valve 100 and/or away from one or more cell opening 112 of the guest prosthetic valve 100.
  • any of the methods can comprise, in some examples, repeating one or more steps disclosed throughout the current specification to form a plurality of punctures and openings in the host valvular structure.
  • steps described above with respect to Figs. 6A-6D can be performed for forming a first leaflet opening in a first host leaflet, after which the delivery apparatus can be retracted from the first host leaflet and steered toward another host leaflet, after which the same steps can be repeated to form a second leaflet opening within the second host leaflet.
  • the procedure can be optionally repeated to form further leaflet openings, such as a third leaflet opening in a third host leaflet.
  • the left coronary artery is positioned lower (that is, proximate to the host valvular structure) than the right coronary artery.
  • the right coronary artery may be sufficiently far from the host valvular structure that implanting the guest prosthetic heart valve within the host valvular structure does not limit access and/or perfusion to the right coronary artery. Accordingly, forming a single leaflet opening in the host valvular structure may be sufficient to ensure access and/or perfusion to both coronary arteries, provided that the leaflet opening is formed and/or positioned to ensure access to the left coronary artery.
  • the host valvular structure can be modified such that the guest prosthetic valve is implanted by being expanded in a leaflet opening of a first host leaflet that faces the left coronary artery, and such that the second leaflet opening is formed in a second host leaflet that faces the right coronary artery (or vice-versa).
  • Example 3 The delivery assembly of any example herein, particularly example 2, wherein the delivery apparatus further comprises an electrically insulated surface extending from the distal end of the nosecone.
  • Example 8 The delivery assembly of any example herein, particularly any one of examples 1 - 7, wherein the electrically conductive surface is coupled to the electric current source via an electrically conductive material.
  • Example 17 The delivery assembly of any example herein, particularly example 16, wherein a frequency of the alternating current is a radio-frequency.
  • Example 19 The delivery assembly of any example herein, particularly any one of examples 1 - 18, further comprising a prosthetic valve positioned over the nosecone shaft.
  • Example 20 The delivery assembly of any example herein, particularly example 19, wherein the delivery apparatus further comprises a push shaft configured to push the prosthetic valve distally.
  • Example 21 The delivery assembly of any example herein, particularly any one of examples 18 - 20, further comprising an inflatable balloon positioned over the nosecone shaft.
  • Example 22 A leaflet perforation method, the method comprising: advancing an electrically conductive surface and a distal end of a nosecone of a delivery apparatus to an anatomical location; and actuating the electrically conductive surface by providing an electric current to the electrically conductive surface; distally advancing the nosecone towards a leaflet; and forming a perforation within the leaflet with the electrically conductive surface.
  • Example 25 The method of any example herein, particularly example 22, wherein the distal end of the nosecone comprises the electrically conductive surface.
  • Example 30 The method of any example herein, particularly example 29, wherein the electrically conductive material is an electric wire.
  • Example 31 The method of any example herein, particularly example 29 or 30, wherein the electrically conductive material extends through a nosecone shaft, the nosecone extending from the nosecone shaft.
  • Example 32 The method of any example herein, particularly example 31, further comprising advancing a guidewire towards the anatomical location, wherein the electrically conductive material extends alongside the guidewire.
  • Example 35 The method of any example herein, particularly example 29 or 30, further comprising advancing a guidewire towards the anatomical location, wherein the electrically conductive material constitutes at least a portion of the guidewire.
  • Example 37 The method of any example herein, particularly any one of examples 22 - 36, wherein the provided electric current is an alternating current.
  • Example 38 The method of any example herein, particularly example 37, wherein a frequency of the alternating current is a radio-frequency.
  • Example 39 The method of any example herein, particularly any one of examples 29 - 38, wherein the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current.
  • anatomical location is a native aortic valve.
  • Example 46 The method of any example herein, particularly example 45, further comprising expanding the expandable prosthetic valve.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Plasma & Fusion (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

Un ensemble de pose comprend un appareil de pose comprenant un arbre de coiffe s'étendant à partir de la poignée, une coiffe s'étendant à partir de l'arbre de coiffe, une surface électriquement conductrice au niveau d'une extrémité distale de la coiffe, et une source de courant électrique couplée électriquement à la surface électriquement conductrice, la source de courant électrique fournissant un courant électrique à la surface électriquement conductrice.
PCT/US2024/050592 2023-10-10 2024-10-09 Appareil de pose avec dispositif de perforation Pending WO2025080729A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363589251P 2023-10-10 2023-10-10
US63/589,251 2023-10-10

Publications (1)

Publication Number Publication Date
WO2025080729A1 true WO2025080729A1 (fr) 2025-04-17

Family

ID=93214923

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/050592 Pending WO2025080729A1 (fr) 2023-10-10 2024-10-09 Appareil de pose avec dispositif de perforation

Country Status (1)

Country Link
WO (1) WO2025080729A1 (fr)

Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
WO2006057920A2 (fr) * 2004-11-22 2006-06-01 Rox Medical, Inc. Dispositifs, systemes et procedes de fabrication d'une fistule arterio-veineuse actionnee par energie
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8007992B2 (en) 2006-10-27 2011-08-30 Edwards Lifesciences Corporation Method of treating glutaraldehyde-fixed pericardial tissue with a non-aqueous mixture of glycerol and a C1-C3 alcohol
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
US20130310833A1 (en) * 2009-04-21 2013-11-21 Peter Brown Methods and devices for access across adjacent tissue layers
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
EP3542763A1 (fr) * 2016-11-16 2019-09-25 Taewoong Medical Co., Ltd. Système de pose d'endoprothèse comprenant une pointe d'électrocautérisation monopolaire
US10603165B2 (en) 2016-12-06 2020-03-31 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US11135056B2 (en) 2017-05-15 2021-10-05 Edwards Lifesciences Corporation Devices and methods of commissure formation for prosthetic heart valve
US20230105063A1 (en) * 2020-03-03 2023-04-06 W. L. Gore & Associates, Inc. Transcatheter tissue cutting system
US20230233349A1 (en) * 2022-01-21 2023-07-27 Covidien Lp Apparatuses for stent delivery and positioning for transluminal application
WO2024191984A1 (fr) * 2023-03-13 2024-09-19 Edwards Lifesciences Corporation Pointe conique hélicoïdale

Patent Citations (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US7393360B2 (en) 2001-10-11 2008-07-01 Edwards Lifesciences Pvt, Inc. Implantable prosthetic valve
US7510575B2 (en) 2001-10-11 2009-03-31 Edwards Lifesciences Corporation Implantable prosthetic valve
WO2006057920A2 (fr) * 2004-11-22 2006-06-01 Rox Medical, Inc. Dispositifs, systemes et procedes de fabrication d'une fistule arterio-veineuse actionnee par energie
US8007992B2 (en) 2006-10-27 2011-08-30 Edwards Lifesciences Corporation Method of treating glutaraldehyde-fixed pericardial tissue with a non-aqueous mixture of glycerol and a C1-C3 alcohol
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US20130310833A1 (en) * 2009-04-21 2013-11-21 Peter Brown Methods and devices for access across adjacent tissue layers
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
EP3542763A1 (fr) * 2016-11-16 2019-09-25 Taewoong Medical Co., Ltd. Système de pose d'endoprothèse comprenant une pointe d'électrocautérisation monopolaire
US10603165B2 (en) 2016-12-06 2020-03-31 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US11135056B2 (en) 2017-05-15 2021-10-05 Edwards Lifesciences Corporation Devices and methods of commissure formation for prosthetic heart valve
US20230105063A1 (en) * 2020-03-03 2023-04-06 W. L. Gore & Associates, Inc. Transcatheter tissue cutting system
US20230233349A1 (en) * 2022-01-21 2023-07-27 Covidien Lp Apparatuses for stent delivery and positioning for transluminal application
WO2024191984A1 (fr) * 2023-03-13 2024-09-19 Edwards Lifesciences Corporation Pointe conique hélicoïdale

Similar Documents

Publication Publication Date Title
EP2723272A2 (fr) Système de valvules cardiaques artificielles implantables par voie percutanée, et procédés et dispositifs associés
US20250375599A1 (en) Helical nosecone
US20250099242A1 (en) Leaflet perforation tools and associated methods
CN217244961U (zh) 一种用于假体心脏瓣膜的对接装置
US20250375239A1 (en) Perforation device with conductive guidewire
US20250366913A1 (en) Perforation assembly with conductive electrode
WO2025080729A1 (fr) Appareil de pose avec dispositif de perforation
US20250375293A1 (en) Tissue perforation assemblies with stiff dialators
US20250352339A1 (en) Delivery assemblies with inflatable balloons axially movable relative to each other
WO2024191987A1 (fr) Ensembles de coupe de tissu biologique avec lames à déplacement axial
WO2025080703A1 (fr) Systèmes de perforation de tissu
US20250380962A1 (en) Tissue cutting tool
WO2025072248A1 (fr) Tubes orientables
WO2025136690A1 (fr) Ensembles de perforation de tissu ayant des bouchons d'aiguille
WO2025199221A1 (fr) Appareil de modification de tissu
US20240299165A1 (en) Methods and devices for folding leaflets of a host valve using commissures of a prosthetic valve
US20250281281A1 (en) Prosthetic valve docking device
CN221205790U (zh) 一种被配置成递送假体植入物的递送设备
WO2025217385A1 (fr) Appareil de perforation de tissus biologiques
US20250186200A1 (en) Leaflet Tissue Modification
WO2025019174A1 (fr) Dispositif d'accueil de prothèse valvulaire
WO2024182495A1 (fr) Outil de coupe de tissu
WO2025064478A1 (fr) Systèmes d'administration orientables
WO2025019171A1 (fr) Dispositif d'implantation de prothèse valvulaire
WO2024220192A1 (fr) Dispositif d'accueil de prothèse valvulaire

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24794664

Country of ref document: EP

Kind code of ref document: A1