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EP-4009906-B1 - HEART VALVE DEPLOYMENT AID

EP4009906B1EP 4009906 B1EP4009906 B1EP 4009906B1EP-4009906-B1

Inventors

  • PINTOR, RAFAEL

Dates

Publication Date
20260506
Application Date
20200722

Claims (15)

  1. A method of simulating the implantation of a hybrid prosthetic aortic heart valve (20), comprising: procuring a hybrid prosthetic aortic heart valve (20) having a valve member (30) and a generally tubular plastically-expandable anchoring skirt (32) attached to and projecting in an inflow direction from the valve member (30), the anchoring skirt (32) having an initial shape that decreases in radial dimension from an outflow end connected to the valve member (30) and defining a first diameter orifice to a free inflow end having a second diameter orifice, the heart valve (20) being attached to a valve holder (22) projecting in an outflow direction; passing a parting sleeve (100) through the anchoring skirt (32) and valve member (30) and attaching the parting sleeve (100) to the valve holder (22); advancing the anchoring skirt (32) into a crimping die (200; 300) to crimp the anchoring skirt (32) and reduce both the first and second diameter orifices, wherein the crimping die (200; 300) comprises a body (202; 302) with a throughbore along a longitudinal axis and an enlarged crimping cavity (212; 312) opening at a first longitudinal end (208; 308) of the body (202; 302), the method including pushing the heart valve (20) anchoring skirt (32) first into the crimping cavity (212; 312), and further including advancing the anchoring skirt (32) into a second end of the crimping cavity (212; 312) to ensure that the first diameter orifice has been crimped to a desired size; delivering the heart valve (20) anchoring skirt (32) first to a simulated aortic heart valve annulus; and plastically-expanding the anchoring skirt (32) to contact the simulated aortic heart valve annulus.
  2. The method of claim 1, wherein the heart valve (20) has a sealing ring (38) surrounding a junction between the valve member (30) and anchoring skirt (32), and the method includes advancing the heart valve (20) anchoring skirt (32) first into the crimping cavity (212; 312) until the sealing ring (38) contacts the first longitudinal end (208; 308) of the body (202; 302).
  3. The method of any one of claims 1 or 2, wherein the crimping die body (202; 302) has an external shape that inhibits the body (202; 302) from rolling around the longitudinal axis on a support surface.
  4. The method of any of claims 1 to 3, wherein the initial shape of the anchoring skirt (32) is conical.
  5. The method of claim 4, wherein the crimping cavity (212; 312) is hemispherical to crimp the anchoring skirt (32) into a spherical curvature.
  6. The method of any of claims 1 to 5, wherein the initial shape of the anchoring skirt (32) is generally conical with a trilobular crimped inflow end.
  7. The method of any of claims 1 to 6, wherein the step of passing the parting sleeve (100) through the anchoring skirt (32) and valve member (30) and attaching the parting sleeve (100) to the valve holder (22) before the heart valve (20) is removed from a storage jar (92), and further including attaching a handling shaft to the parting sleeve (100) to remove the heart valve (20) from the storage jar (92).
  8. The method of any of claims 1 to 7, wherein the crimping operation is repeated in the crimping cavity (212; 312), if the anchoring skirt does not fully fit into the second end of the crimping cavity (212; 312).
  9. The method of any of claims 1 to 8, wherein the crimping operation reduces the maximum diameter of the expandable skirt by at least about 1.5 mm.
  10. The method of any of claims 1 to 9, further comprising the step of removing the heart valve from sterile packaging after procuring the hybrid prosthetic heart valve.
  11. A kit including a hybrid prosthetic aortic heart valve (20) and a crimping die (200; 300), the kit comprising: a hybrid prosthetic aortic heart valve (20) having a valve member and a tubular plastically-expandable anchoring skirt (32) attached to and projecting in an inflow direction from the valve member, the anchoring skirt (32) having an initial shape that decreases in radial dimension from an outflow end connected to the valve member and defining a first diameter orifice to a free inflow end having a second diameter orifice; and a crimping die (200; 300) including a crimping cavity (212; 312), the crimping die (200; 300) configured to crimp the anchoring skirt (32) and reduce both the first and second diameter orifices when the valve (20) is advanced with the anchoring skirt (32) first into the crimping cavity (212; 312), wherein the crimping cavity (312) opens at a first longitudinal end (308) of the body (302), and the crimping die (300) further includes a measuring cavity (310) at a second longitudinal end (304) of the body (302) with a diameter equal to a largest diameter of the crimping cavity (312).
  12. The kit of claim 11, wherein the crimping die (200; 300) comprises a body (202; 302) with a throughbore along a longitudinal axis and the crimping cavity (212; 312) opens at a first longitudinal end (208; 308) of the body (202; 302).
  13. The kit of claim 12, wherein the heart valve (30) further comprises a sealing ring (38) surrounding a junction between the valve member and anchoring skirt (32) such that the heart valve (30) is advanceable into the crimping cavity (212; 312) until the sealing ring (38) contacts the first longitudinal end (208; 308) of the body (202; 302).
  14. The kit of claim 13, wherein the sealing ring (38) includes an axially undulating shape with peaks and valleys, and the first longitudinal end (208; 308) of the crimping die body (202; 302) has a matching axially undulating shape surrounding the crimping cavity (212; 312).
  15. The kit of any of claims 11 to 14, wherein the crimping die body (202; 302) has an external shape that inhibits the body (202; 302) from rolling on a support surface around the longitudinal axis (206; 306).

Description

RELATED APPLICATIONS This application claims the benefit of U.S. Patent Application No. 62/883,013, filed August 5, 2019. Technical field The present disclosure generally relates to an aid for use when implanting prosthetic heart valves and, more particularly, to an aid which adjusts a delivery profile of a prosthetic heart valve. BACKGROUND Heart valve disease continues to be a significant cause of morbidity and mortality, resulting from a number of ailments including rheumatic fever and birth defects. Currently, the primary treatment of aortic valve disease is valve replacement. Worldwide, approximately 300,000 heart valve replacement surgeries are performed annually, and about one-half of these patients received mechanical heart valves, which are composed of rigid, synthetic materials. The remaining patients received bioprosthetic heart valve replacements, which utilize biologically derived tissues for flexible fluid occluding leaflets. The most successful bioprosthetic materials for flexible leaflets are whole porcine valves and separate leaflets made from bovine pericardium stitched together to form a tri-leaflet valve. However, flexible leaflets formed of polymeric, fiber-reinforced, and other synthetic materials have also been proposed. The most common flexible leaflet valve construction includes three leaflets mounted to commissure posts around a peripheral non-expandable support structure with free edges that project toward an outflow direction and meet or coapt in the middle of the flowstream. A suture-permeable sewing ring is provided around the inflow end. One prior bioprosthetic valve for aortic valve replacement is provided by the Edwards Intuity® valve system available from Edwards Lifesciences of Irvine, CA. Aspects of the Edwards Intuity valve system are disclosed in U.S. Patent Nos. 8,641,757 and 9,370,418 both to Pintor, et al. and 8,869,982 to Hodshon, et al. The Edwards Intuity valve is a hybrid of a generally non-expandable valve member and an expandable anchoring stent that helps secure the valve in place in a shorter amount of time. The implant process only requires three sutures, which reduces the time-consuming process of tying knots. A delivery system advances the Edwards Intuity valve with the stent at the leading end until it is located within the left ventricle, at which point a balloon inflates to expand the stent against the ventricular wall. The long handle and delivery system design facilitate access through smaller incisions (mini-sternotomy or right anterior thoracotomy) than used in full sternotomies. Although the anchoring stent on the Intuity valve is conically crimped down on its inflow (leading) end, sometimes the overall diameter is larger than desired and the surgeon has difficulty implanting the valve. This situation can arise, for example, when the valve sizer used to assess the native valve orifice does not accurately reflect the size and geometry of the Intuity valve. Difficulties can also be experienced by aggressive surgeons that force the largest diameter sizer they can into the valve annulus/LVOT to determine the valve size to be implanted. For example, challenges include difficulty seating the valve, valve pop up, valve displacement while tying implant sutures, or improper valve position after tying the sutures. WO 2014/164832 A1 relates to a quick-connect heart valve prosthesis that is quickly and easily implanted during a surgical procedure. Therewith described are crimping devices. The heart valve includes a substantially non-expandable, noncompressible prosthetic valve and a plastically expandable stent frame, thereby enabling attachment to the annulus without sutures. The prosthetic valve is a commercially available valve with a sewing ring and the stent frame attached thereto. The stent frame expands from a conical deployment shape to a conical expanded shape, and has a cloth covering its entirety as well as a plush sealing flange around its periphery to prevent paravalvular leaking. EP 2 921 135 A1 relates to a heart valve handling system for a prosthetic heart valve, as well as to the use of said handling system and a method for loading a prosthetic heart valve onto a prosthetic heart valve deployment system. The handling system comprises a holder having a longitudinal axis extending from a proximal to a distal direction, the holder having a holding element, having a first end and a second end, first holder legs for stabilizing the holder, wherein the first holder legs are flexibly connected with the holding element's second end and extend in the distal direction; first tongue elements for keeping open the leaflets of the prosthetic heart valve, wherein the first tongue elements are flexibly connected to the second end of the holding element; and second tongue elements for fixating the valve to the holder, wherein the second tongue elements are flexibly connected to the second end of the holding element. In view of the foregoing, it is apparent tha