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EP-3846698-B1 - STENT LOADING DEVICE

EP3846698B1EP 3846698 B1EP3846698 B1EP 3846698B1EP-3846698-B1

Inventors

  • DIEDERING, Jason S.
  • KUMAR, Saravana B.

Dates

Publication Date
20260506
Application Date
20190904

Claims (12)

  1. A loading device (200) for collapsing a collapsible stent (100) in preparation for delivery and implantation into a body, the loading device comprising: a proximal decreasing diameter section (202) defining a lumen with an inner diameter smoothly transitioning and ranging from a maximum at a proximal end to a minimum at a distal end of the decreasing diameter section; and a constant diameter section (204) connected to, or integrated, with the proximal decreasing diameter section (202) at the distal end of the decreasing diameter section (202) and defining a lumen with an inner diameter that is substantially constant and substantially equal to the minimum diameter of the proximal decreasing diameter section (202); and a sheath (300') that is removably connected with the constant diameter section (204) and is adapted to be translated within the constant diameter section, the sheath (300') comprising: a lumen therethrough and operatively connected to, and extending within the lumen of, the constant diameter section (204); an outer diameter that is the same as, or smaller than, the minimum inner diameter of the proximal decreasing diameter section (202); a planar sheet (304) that is adaptable to define a tubular form with an outer diameter that enables translation and/or rotation within the lumen of the constant diameter section (204); a longitudinal slot when in the tubular form and the constant diameter section (204) comprises a male member (206) adapted to engage with, and slide within, the longitudinal slot when the sheath (300') is translated within the lumen of the constant diameter section (204); and a radial slot (302') in communication with the longitudinal slot, wherein the male member (206) is further adapted to slide within the radial slot (302') to prevent longitudinal translation between the constant diameter section (204) and the sheath (300').
  2. The loading device (200) of claim 1, wherein the sheath (300') extends all the way through the lumen defined by the constant diameter section (204).
  3. The loading device (200) of claim 1, wherein the sheath (300') extends part of the way through the lumen defined by the constant diameter section (204).
  4. The loading device (200) of claim 1, further comprising fluid disposed within the lumen of the proximal decreasing diameter section (202), the lumen of the constant diameter section (204) and/or the lumen of the sheath (300').
  5. The loading device (200) of claim 1, wherein relative rotation between the sheath (300') and the constant diameter section (204) is prevented by the engagement of the male member (206) with the longitudinal slot.
  6. The loading device (200) of claim 1, wherein the stent (100) comprises a prosthetic heart valve frame.
  7. The loading device (200) of claim 6, wherein the stent (100) comprises a prosthetic mitral valve frame.
  8. The loading device (200) of claim 6, wherein the stent (100) comprising the prosthetic heart valve frame is delivered transapically to a location within a patient's heart.
  9. The loading device (200) of claim 1, wherein the stent (100) is delivered by one of the following delivery methods: femoral access, venous access, trans-apical, trans-aortic, trans-septal, trans-atrial, retrograde from the aorta delivery techniques.
  10. The loading device (200) of claim 1, wherein the stent (100) comprises curved or spiral struts (108') that, when collapsed into the loading device (200), fit together into a predictable and repeatable shape.
  11. The loading device (200) of claim 1, wherein the sheath (300') comprises a delivery sheath adapted to allow translation of the stent in a collapsed configuration to an anatomical site.
  12. The loading device (200) of claim 1, wherein the sheath (300') comprises a transitional sheath, wherein a distal end of the sheath is operatively connected with a delivery sheath.

Description

BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The invention relates to devices for implanting devices within a heart chamber. More specifically, the invention relates to devices configured to load a stent, e.g., a prosthetic heart valve frame, into a lumen of a delivery sheath or catheter for translation through the lumen to the distal end of the delivery sheath or catheter. DESCRIPTION OF THE RELATED ART Stents in general, and prosthetic cardiac valve and left atrial appendage occluding devices specifically, are well known in the art. The native heart valves, e.g., aortic, pulmonary, tricuspid and mitral valves, are critical in assuring the forward-only flow of an adequate supply of blood through the cardiovascular system. These heart valves may lose functionality as a result of, inter alia, congenital, inflammatory, infectious diseases or conditions. Early interventions repaired or replaced the dysfunctional valve(s) during open heart surgery. More recently, besides the open heart surgical approach discussed above, gaining access to the valve of interest may be achieved percutaneously via one of at least the following known access routes: transapical; transfemoral; transatrial; and transseptal delivery techniques, collectively transcatheter techniques. Generally, in a transcatheter technique, the prosthetic valve is mounted within a stented frame that is capable of achieving collapsed and expanded states. The device is collapsed and advanced through a sheath or delivery catheter positioned in a blood vessel of the patient until reaching the implantation site. The stented frame is generally released from the catheter or sheath and, by a variety of means, expanded with the valve to the expanded functional size and orientation within the heart. One of the key issues is ease of delivery of the prosthetic valve, including the stent frame and valve. More specifically the outer diameter of the collapsed device within the catheter is of significant interest. The present invention addresses this issue. DESCRIPTION OF THE RELATED ART The human heart comprises four chambers and four heart valves that assist in the forward (antegrade) flow of blood through the heart. The chambers include the left atrium, left ventricle, right atrium and right ventricle. The four heart valves include the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve. See generally Figure 1. The mitral valve is located between the left atrium and left ventricle and helps control the flow of blood from the left atrium to the left ventricle by acting as a one-way valve to prevent backflow into the left atrium. Similarly, the tricuspid valve is located between the right atrium and the right ventricle, while the aortic valve and the pulmonary valve are semilunar valves located in arteries flowing blood away from the heart. The valves are all one-way valves, with leaflets that open to allow forward (antegrade) blood flow. The normally functioning valve leaflets close under the pressure exerted by reverse blood to prevent backflow (retrograde) of the blood into the chamber it just flowed out of. For example, the mitral valve when working properly provides a one-way valving between the left atrium and the left ventricle, opening to allow antegrade flow from the left atrium to the left ventricle and closing to prevent retrograde flow from the left ventricle into the left atrium. This retrograde flow, when present, is known as mitral regurgitation or mitral valve regurgitation. Native heart valves may be, or become, dysfunctional for a variety of reasons and/or conditions including but not limited to disease, trauma, congenital malformations, and aging. These types of conditions may cause the valve structure to fail to close properly resulting in regurgitant retrograde flow of blood from the left ventricle to the left atrium in the case of a mitral valve failure. Mitral valve regurgitation is a specific problem resulting from a dysfunctional mitral valve that allows at least some retrograde blood flow back into the left atrium from the right atrium. In some cases, the dysfunction results from mitral valve leaflet(s) that prolapse up into the left atrial chamber, i.e., above the upper surface of the annulus instead of connecting or coapting to block retrograde flow. This backflow of blood places a burden on the left ventricle with a volume load that may lead to a series of left ventricular compensatory adaptations and adjustments, including remodeling of the ventricular chamber size and shape, that vary considerably during the prolonged clinical course of mitral regurgitation. Regurgitation can be a problem with native heart valves generally, including tricuspid, aortic and pulmonary valves as well as mitral valves. Native heart valves generally, e.g., mitral valves, therefore, may require functional repair and/or assistance, including a partial or complete replacement. Such intervention may take several forms including open he