Assembly for delivering a prosthetic heart valve

• US 10,507,103 B2
• Filed: 11/26/2018
• Issued: 12/17/2019
• Est. Priority Date: 06/13/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taylor, David M.
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US16/200,439
• Publication Number:
  US 20190133762A1
• Time in Patent Office: 386 Days
• Field of Search: 600184
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

An assembly for delivering a prosthetic heart valve to a native heart valve is disclosed. The assembly includes a self-expanding prosthetic heart valve formed with an expandable metallic stent and a flexible valvular structure. The assembly also includes a delivery apparatus having a delivery sleeve. The delivery sleeve includes a selectively steerable section and a distal portion for retaining the prosthetic heart valve in a compressed state. A handle is coupled to a proximal end of the delivery sleeve and a pull wire extends from the handle to the steerable section of the delivery sleeve. The handle preferably includes a rotatable portion for actuating the pull wire and thereby selectively controlling a curvature of the steerable section during advancement through the patient'"'"'s vasculature. In preferred embodiments, the steerable section includes a flexible metallic tubular portion formed with a plurality of circumferentially extending openings.

Claims

1. A medical assembly, comprising:

a delivery system comprising an inflatable balloon along a distal end portion of the delivery system;

a prosthetic valve retained in a radially compressed state over the inflatable balloon;

a loader comprising a tube portion extending over the prosthetic valve and the inflatable balloon of the delivery system; and

an introducer comprising a sleeve and a housing attached to a proximal end of the sleeve;

wherein the sleeve is configured to be inserted into a blood vessel of a patient so that an inner passageway of the sleeve is in fluid communication with the blood vessel and the housing is located outside the blood vessel;

wherein the tube portion of the loader is configured to pass through the housing and into the inner passageway of the sleeve so that the delivery system and the prosthetic valve can be passed through the housing while the prosthetic valve is inside the tube portion and then advanced from the tube portion through the inner passageway of the sleeve and into the blood vessel after the sleeve is inserted into the blood vessel;

wherein the introducer comprises one or more valves located inside the housing and configured to engage an outer surface of the tube portion of the loader when the tube portion is inserted into the introducer; and

wherein the loader further comprises a cap portion coupled to a proximal end portion of the tube portion and a seal member inside the cap portion and engaging an outer surface of the delivery system.

2. The medical assembly of claim 1, wherein the tube portion of the loader has a proximal opening, a distal opening, and an inner lumen extending between the proximal opening and the distal opening, and wherein the prosthetic valve and the inflatable balloon are disposed in the inner lumen.

3. The medical assembly of claim 1, wherein the sleeve is coated with a hydrophilic coating.

4. The medical assembly of claim 1, wherein the inner passageway of the introducer has a circumference that is smaller than an outer circumference of the prosthetic valve in the radially compressed state prior to being inserted into the introducer.

5. The medical assembly of claim 1, wherein the tube portion of the loader is configured to be inserted through a proximal opening and the one or more valves of the housing so that the prosthetic valve and the delivery system can be advanced outwardly through a distal opening of the tube portion into the inner passageway of the sleeve and then outwardly through a distal opening of the sleeve into the blood vessel without contacting the one or more valves.

6. The medical assembly of claim 1, wherein the cap portion has a cap opening so as to allow insertion of the distal end portion of the delivery system and the prosthetic valve retained on the inflatable balloon through the cap opening and into the tube portion.

7. The medical assembly of claim 6, wherein the seal member has a seal opening that is configured to align with the cap opening.

8. The medical assembly of claim 6, wherein the cap portion and the tube portion are configured to be removably couplable to each other.

9. The medical assembly of claim 8, wherein the cap portion has a first threaded surface that is configured to threadably engage with a second threaded surface located at the proximal end portion of the tube portion.

10. The medical assembly of claim 1, wherein the loader and the introducer are configured to be removably couplable to each other.

11. The medical assembly of claim 10, wherein the tube portion of the loader comprises one or more flexible flanges, each flange having a snap member, and wherein a proximal end portion of the housing comprises one or more ridges configured to bear against one of the snap members of the one or more flanges to secure the tube portion to the housing.

12. A medical assembly, comprising:

a delivery system comprising an inflatable balloon along a distal end portion of the delivery system;

a prosthetic valve retained in a radially compressed state over the inflatable balloon;

an introducer;

a tube portion and a cap portion; and

a seal member disposed inside the cap portion;

wherein the cap portion is directly connected to a proximal end portion of the tube portion;

wherein the tube portion has an inner lumen having a distal opening located at a distal end of the tube portion, wherein the prosthetic valve and the inflatable balloon are disposed in the inner lumen;

wherein the tube portion is configured to be inserted into the introducer which is configured to be inserted into a blood vessel of a patient;

wherein the tube portion and the cap portion are moveable together when the tube portion is inserted into the introducer;

and wherein the tube portion is so sized that insertion of the tube portion into the introducer can cause the distal end of the tube portion and the prosthetic valve disposed therein to pass through one or more valves of the introducer and into an inner passageway of the introducer, thereby allowing the prosthetic valve and the delivery system to be advanced outwardly through the distal opening of the inner lumen of the tube portion into the inner passageway of the introducer and then outwardly through a distal opening of the introducer into the blood vessel without contacting the one or more valves of the introducer.

13. The medical assembly of claim 12, wherein the cap portion has a larger diameter than the tube portion.

14. The medical assembly of claim 13, wherein the cap portion has a cap opening so as to allow insertion of the distal end portion of the delivery system and the prosthetic valve retained thereon on the inflatable balloon through the cap opening and into the tube portion.

15. The medical assembly of claim 14, wherein the seal member has a seal opening that is configured to align with the cap opening, and wherein the delivery system extends through the seal opening and an outer surface of the delivery system engages the seal opening so as to block blood flow through the seal member.

16. The medical assembly of claim 12, wherein the cap portion and the tube portion are configured to be removably couplable to each other.

17. The medical assembly of claim 16, wherein the cap portion has a first threaded surface that is configured to threadably engage with a second threaded surface located at the proximal end portion of the tube portion.

18. The medical assembly of claim 12, wherein the tube portion comprises one or more flexible flanges, each flange having a snap member being configured to bear against a corresponding ridge located at a proximal end portion of the introducer to secure the tube portion to the introducer.

19. A medical assembly, comprising:

a loader comprising a tube portion and cap portion coupled to a proximal end portion of the tube portion, the cap portion having a larger diameter than the tube portion, the tube portion being configured to receive a distal end portion of a delivery system and a prosthetic valve retained in a radially compressed state over an inflatable balloon of the delivery system, and the cap portion having a cap opening so as to allow insertion of the distal end portion of the delivery system and the prosthetic valve retained thereon through the cap opening and into the tube portion; and

an introducer comprising a sleeve and a housing attached to a proximal end of the sleeve, the sleeve being configured to be inserted into a blood vessel of a patient so that an inner passageway of the sleeve is in fluid communication with the blood vessel and the housing is located outside the blood vessel;

wherein the introducer further comprises an end piece attached to a proximal end of the housing, the end piece having an opening extending into an area of the housing where one or more valves are located and configured to block blood flow from the inner passageway of the sleeve to the opening of the end piece;

wherein the tube portion of the loader is so sized that it can be inserted through the opening of the end piece and the one more valves in the housing and into the inner passageway of the sleeve;

wherein the loader further comprises a seal member configured to be secured to the cap portion, the seal member having a seal opening that is configured to align with the cap opening, and wherein the seal opening is sized such that when the delivery system is inserted through the cap opening and the seal opening, an outer surface of the delivery system engages the seal opening so as to block blood flow through the seal member;

wherein the cap portion has an interior thread that is configured to threadably engage with an exterior thread located at the proximal end portion of the tube portion; and

wherein the tube portion of the loader comprises one or more flexible flanges, each flange having a snap member being configured to bear against a corresponding ridge located at the end piece of the introducer so as to secure the tube portion to the end piece.