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EP-4355269-B1 - LOADING ASSEMBLY AND DELIVERY APPARATUS FOR AN EXPANDABLE PROSTHETIC MEDICAL DEVICE

EP4355269B1EP 4355269 B1EP4355269 B1EP 4355269B1EP-4355269-B1

Inventors

  • LOPEZ, JOSE, LUIS
  • VALENCIA, Salomon, Xavier
  • BUZEA, Brad
  • LEGGIO YEPEZ, Alessandro, Marco

Dates

Publication Date
20260506
Application Date
20220613

Claims (15)

  1. A medical system comprising: a delivery apparatus (100) for implanting a prosthetic medical device in a patient's body, the delivery apparatus (100) comprising: a flexible shaft (304); a coupling (300) attached to a distal end of the flexible shaft (304); and a delivery capsule (314) coupled to the coupling (300) and extending distally from the coupling (300), away from the distal end of the flexible shaft (304); and a loading assembly (310) comprising: a loading capsule (316) comprising a plurality of axially extending flexible members (326) configured to couple to an outer surface of the coupling (300) and flex radially outward; and a collar (318) disposed around the loading capsule (316) and configured to lock the plurality of flexible members (326) in engagement with the coupling (300) such that the plurality of flexible members (326) cannot flex radially outward.
  2. The system of claim 1, wherein the loading assembly further comprises a loader (320) coupled to a distal end portion of the loading capsule and comprising a tapered portion (321) configured to extend into a distal end portion of the delivery capsule (314) when the loading capsule is arranged around the delivery capsule (314) and coupled to the coupling (300).
  3. The system of claim 2, wherein the tapered portion (321) comprises a plurality of wedge-shaped petals (730) having free ends that extend into the distal end portion of the delivery capsule (314) and wherein the distal end portion of the delivery capsule (314) surrounds an outer surface of the plurality of petals (730).
  4. The system of either claim 2 or claim 3, further comprising a radially expandable and compressible prosthetic heart valve (102), and wherein the loader (320) is configured to load the prosthetic heart valve (102), in an at least partially radially compressed state, into the delivery capsule (314) while the loading capsule is coupled to the coupling (300).
  5. The system of any one of claims 1-4, wherein the coupling (300) comprises a hard, plastic material, wherein the distal end of the flexible shaft (304) comprises a flexible material, and wherein the flexible shaft (304) is steerable and has an adjustable curvature.
  6. The system of any one of claims 1-5, wherein the coupling (300) comprises a first portion (344) coupled to the delivery capsule (314), a second portion (346) comprising one or more channels (340) depressed, in a radial direction, into the outer surface of the coupling (300), and a third portion (348) coupled to the distal end of the flexible shaft (304), wherein the second portion (346) is disposed between the first portion (344) and the third portion (348), and wherein the one or more channels (340) are configured to receive one or more inner protrusions extending radially inward from inner surfaces of the plurality of flexible members (326).
  7. The system of claim 6, wherein each flexible member of the plurality of flexible members (326) comprises a free end portion (344) with an inner protrusion (338) extending radially inward from an inner surface of the flexible member, the inner protrusion configured to be received within and couple to a corresponding channel of the one or more channels (340) of the coupling (300).
  8. The system of any one of claims 1-7, wherein the collar (318) is disposed around and configured to slide along an outer surface of the loading capsule, and wherein an inner surface of the collar (318) comprises a first mating element (376; 424; 518) configured to mate with and couple to a complementary second mating element (374; 410; 510) on an outer surface of one or more of the plurality of flexible members (326) such that plurality of flexible members (326) are locked in engagement with the coupling (300).
  9. The system of any one of claims 1-8, wherein the loading assembly further comprises a device housing (604) removably coupled to the loading capsule, the device housing (604) having an inner cavity configured to receive and store a prosthetic medical device in an at least partially radially expanded state.
  10. The system of claim 9, wherein the device housing (604) comprises a proximal end portion including a first attachment interface (714) and the loading assembly comprises a second attachment interface (708) included on or attached to a distal end portion of the loading capsule, the first attachment interface (714) and the second attachment interface (708) configured to removably couple to one another, and wherein a distal end portion of the device housing (604) comprises the inner cavity.
  11. The system of claim 8, wherein the first mating element (376; 424; 518) is a slot (376) and the second mating element (374; 410; 510) is an outer protrusion (374), the outer protrusion (374) configured to slide into and along the slot (376) as the collar (318) rotates and be held within a closed end of the slot (376) by one or more retaining feature (382)s of the slot (376).
  12. The system of claim 8, wherein the first mating element (376; 424; 518) is a helical groove (424) depressed into the inner surface of the collar (318) and the second mating element (374; 410; 510) is a helical thread (410), the helical groove (424) configured to slide along and thread onto the helical thread (410).
  13. The system of claim 8, wherein the first mating element (376; 424; 518) is a projection (518) extending from the inner surface of the collar (318) and the second mating element (374; 410; 510) is a slot (510) in the outer surface of one flexible member of the plurality of flexible members (326), the projection (518) configured to extend into and couple with the slot (510).
  14. The system of any one of claims 4-13, wherein the prosthetic heart valve (102) is at least partially self-expanding.
  15. The system of claim 14, wherein the prosthetic heart valve (102) is both mechanically expandable and self-expanding.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Patent Application No. 63/210,421, filed June 14, 2021. FIELD The present disclosure relates to a loading assembly for loading a prosthetic medical device into a delivery apparatus. BACKGROUND The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. Once at the implantation site, the prosthetic heart valve can be expanded to its functional size by, for example, actuating a mechanical actuator that applies a radially outward force to the prosthetic valve. Such prosthetic heart valves (ones that rely on a mechanical actuator for expansion) can be referred to as "mechanically expandable" prosthetic heart valves. In other examples, the prosthetic heart valve can be self-expanding. For example, such self-expanding valves can be constructed from a shape-memory material and can be preformed in a radially expanded state so that the prosthetic valves are naturally biased to this radially expanded state. Such self-expanding valves can be held in a crimped state by a restraint (e.g., a sheath or capsule) during delivery, but can be released from this restraint once at the implantation site so that they can self-expand to their functional size. For example, a user can push the self-expanding valve out of a delivery sheath by, for example, actuating a pushing mechanism of the delivery assembly. A loader or loading assembly can be used to load the prosthetic heart valve (e.g., the mechanically expandable or self-expanding prosthetic heart valve) in a radially compressed state into a delivery sheath or capsule of the delivery apparatus that is configured to contain and protect the prosthetic heart valve during delivery. For example, in some instances, a loading assembly can couple to an end of the delivery apparatus and be configured to receive an at least partially radially compressed or crimped prosthetic heart valve and facilitate transfer of the prosthetic heart valve into the delivery sheath or capsule of the delivery apparatus (or a distal end portion of the delivery apparatus that is configured to contain the prosthetic heart valve in the radially compressed state during delivery to the implantation site). However, in some examples, the coupling interface between the loading assembly and the distal end portion of the delivery apparatus can cause degradation to the delivery apparatus and/or may not provide a secure connection. Accordingly, a need exists for an improved and more secure coupling interface between a loading assembly and a distal end portion of a delivery apparatus for a prosthetic medical device, such as a prosthetic heart valve. US 2014/144000 A1 relates to a crimping tool which includes a housing portion defining a funnel segment and a suture locking mechanism positioned to lock sutures therein. One or more sutures can be coupled with a prosthesis and secured to the suture locking mechanism. The suture locking mechanism can be operated to draw the prosthesis through the funnel segment. SUMMARY The claimed invention is defined in independent claim 1 and relates to a medical system comprising a delivery apparatus for implanting a prosthetic medical device in a patient's body, and a loading assembly. Some preferred configurations of the claimed invention are defined in dependent claims 2 to 15. Also described herein are related aspects, examples, embodiments and arrangements useful for understanding the claimed invention, and which do not necessarily constitute embodiments of the claimed invention. The subject-matter for which protection is sought is defined by the claims. Described herein are examples of assemblies and methods for securing a loading assembly to a distal end portion of a delivery apparatus and loading a prosthetic medical device into a delivery capsule of the delivery apparatus using the loading assembly. In some examples, a coupling can be configured to connect the delivery capsule to a distal end of a shaft of the delivery apparatus and the coupling can include one or more channels depressed into an outer surface of th