Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
  • A61F2/2427—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
  • 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
  • A61F2/95—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
  • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
• • 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
  • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
  • A61F2230/0028—Shapes in the form of latin or greek characters
  • A61F2230/0054—V-shaped
• • 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
  • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2240/001—Designing or manufacturing processes
• • 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
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
  • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

• the terms “a,” “an,” and “at least one” encompass one or more of the specified element. That is, if two of a particular element are present, one of these elements is also present and thus “an” element is present.
• the terms “a plurality of’ and “plural” mean two or more of the specified element.
• the delivery apparatus 100 can include a second shaft 152.
• the second shaft 152 extends distally from the handle portion 132 and co-axially though the first shaft 134.
• the first shaft 134 is the outermost shaft of the delivery apparatus and therefore can be referred to as the outer shaft 134 of the delivery apparatus.
• the second shaft 152 is the innermost shaft of the delivery apparatus and therefore can be referred to as the inner shaft 152 of the delivery apparatus.
• the delivery apparatus 100 may include a third shaft that is an intermediate shaft, arranged between the inner shaft 152 and the outer shaft 134.
• a nosecone 144 can be connected to or mounted on a distal end portion of the inner shaft 152.
• the nosecone 144 can have a tapered outer surface as shown for atraumatic tracking of the delivery apparatus 100 through a patient's vasculature.
• the inner shaft 152 extends through the prosthetic valve 10.
• the distal end portion 222 can be crimped to a greater extent than the middle portion 224 by virtue of there being less material (e.g., skirt or leaflet material) located within the distal end portion, thereby allowing the device 206 to assume a tapered shape along the distal end portion 222.
• material e.g., skirt or leaflet material
• each notch 270 can include an elongate end 271, extending from the distal end 272 to the location 274 and a more bulbous end 273 arranged at the location 274 (e.g., at its proximal end).
• the wings formed by the notches can have increased flexibility (e.g., increased ability to expand and/or compress radially).
• the capsule 220 when in the delivery configuration, can be arranged adjacent to and partially inside an interior of the nosecone 144 of the delivery apparatus.
• the distal end of the narrowed distal end portion 230 can be inserted into an opening within the nosecone, forming a relatively continuous outer surface between the nosecone 144 and the capsule 220.
• This configuration during delivery of the prosthetic medical device to the target implantation site, may result in a more atraumatic configuration. As a result, degradation to the introducer sheath and/or patient’s anatomy during advancing the distal end portion of the delivery apparatus to the target implantation site may be reduced.
• the method at 302 can further include narrowing a plurality of notches arranged between and separating the plurality of wings, where each notch of the plurality of notches is arranged between two adjacent wings of the plurality of wings, and where radially expanding the distal end portion includes widening each notch of the plurality of notches.
• the method include, upon reaching a target implantation site for the prosthetic medical device (e.g., the heart for a prosthetic heart valve), retracting the capsule, in an axial direction, away from the prosthetic medical device and radially expanding the distal end portion so that the outer diameter of the distal end portion is equal to or larger than a diameter of the middle portion of the capsule.
• a target implantation site for the prosthetic medical device e.g., the heart for a prosthetic heart valve
• the prosthetic medical device may be more easily loaded into the capsule and removed from the capsule, while still allowing the capsule to have a reduced effective length in the delivery configuration.
• Example 1 A capsule of a delivery apparatus configured to deliver a prosthetic medical device to a target implantation site, the capsule comprising: at least one end portion, arranged at a proximal end or distal end of the capsule, that narrows in diameter from a wider outer diameter of a middle portion of the capsule to a narrower outer diameter at an end of the at least one end portion, the end spaced away from the middle portion of the capsule, wherein the at least one end portion is configured to expand to the wider outer diameter in response to a radially outward pressure from the prosthetic medical device during removal of the prosthetic medical device from inside of the capsule.
• Example 14 The capsule of any example herein, particularly any one of examples 1-9 and 13, wherein the at least one end portion of the capsule comprises an elastomeric material formed into a tapered shape that narrows in diameter from the wider outer diameter of the middle portion of the capsule to the narrower outer diameter at the end of the at least one end portion that is spaced away from the middle portion of the capsule.
• Example 16 A delivery apparatus, comprising: an outer shaft; a nosecone coupled to a distal end of an inner shaft of the delivery apparatus, the inner shaft arranged within at least a portion of the outer shaft; and a capsule coupled to a distal end of the outer shaft, proximal to the nosecone, and configured to move axially relative to the nosecone, the capsule comprising: a cylindrical middle portion that has a first outer diameter along its length; and an end portion configured to move between a first configuration where the end portion tapers radially inward from the middle portion so that the end portion has a reduced diameter relative to the outer diameter of the middle portion and a second configuration where the end portion is expanded and has an expanded diameter that is larger than the reduced diameter.
• Example 26 The delivery apparatus of any example herein, particularly example 25, wherein each wing is axially orientated, relative to a central longitudinal axis of the capsule, and angles radially inward from a wider, proximal end of the wing to a narrower, distal end of the wing, the distal ends of the plurality of wings forming the end of the end portion of the capsule.
• Example 28 The delivery apparatus of any example herein, particularly any one of examples 16-27, wherein the capsule comprises an elastic, self-expanding metallic or polymeric material.
• a method comprising: forming a tapered, narrower diameter portion of a capsule of a delivery apparatus at a distal end portion of the capsule, so that an outer diameter of the distal end portion narrows radially inward from a wider, middle portion of the capsule, the capsule arranged on a distal end portion of the delivery apparatus and configured to cover and retain a radially compressed prosthetic heart valve therein; and upon reaching a target implantation site for the prosthetic heart valve, retracting the capsule, in an axial direction, away from the prosthetic heart valve and radially expanding the distal end portion so that the outer diameter of the distal end portion is equal to or larger than a diameter of the middle portion of the capsule.
• Example 49 The method of any example herein, particularly any one of examples 46 and 47, wherein forming the tapered, narrower diameter portion of the capsule includes allowing the distal ends of the plurality of wings to retract radially inward into a non- deformed, resting state and, in response to retracting the capsule away from the prosthetic heart valve, elastically deforming the plurality of wings into an expanded state where distal ends of the plurality of wings are spaced further apart from one another around a circumference of the distal end portion.

Landscapes

• Health & Medical Sciences (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)
• Media Introduction/Drainage Providing Device (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Related Child Applications (1)

Publications (1)

Family

ID=76662557

Family Applications (1)

Country Status (5)

Citations (13)

Family Cites Families (4)

• 2021
  • 2021-06-07 EP EP21735826.6A patent/EP4161443A1/en active Pending
  • 2021-06-07 WO PCT/US2021/036107 patent/WO2021252321A1/en not_active Ceased
  • 2021-06-07 CN CN202180057121.8A patent/CN116096331A/zh active Pending
  • 2021-06-07 JP JP2022575432A patent/JP7758690B2/ja active Active
• 2022
  • 2022-12-06 US US18/075,939 patent/US20230099978A1/en active Pending
• 2025
  • 2025-10-08 JP JP2025170322A patent/JP2025188168A/ja active Pending

Patent Citations (13)

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events