Integrated heart valve delivery system

• US 10,179,048 B2
• Filed: 02/11/2016
• Issued: 01/15/2019
• Est. Priority Date: 09/08/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marchand, Philippe, Taylor, David M., Milich, Robert, Evans, David J., Chia, Christopher, Cayabyab, Ronaldo C., Bowes, Robert
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US15/042,049
• Publication Number:
  US 20160158009A1
• Time in Patent Office: 1,069 Days
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature without the need for a separate introducer sheath. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

Claims

1. An introducer sheath for passage of a prosthetic device supported on a delivery apparatus, the introducer sheath comprising:

a handle; and

an elongated sleeve including a proximal end connected to the handle and a distal end and defining a lumen extending from the proximal end to the distal end of the elongated sleeve, the elongated sleeve having a resilient, radially inward bias configured to radially contract under its own resiliency, the lumen having a length extending from the proximal end to the distal end, wherein the handle and the lumen are configured to allow passage of the prosthetic device supported on the delivery apparatus through the handle and the entire length of the lumen from the proximal end to the distal end;

the elongated sleeve further including at least an inner layer and an outer layer,

the inner layer including a lattice defining a pattern of openings and extending between the proximal and distal ends of the elongated sleeve, and the outer layer extending around the inner layer;

wherein the elongated sleeve is radially expandable from a first diameter of the lumen to a second diameter of the lumen along the entire length of the lumen against the resilient, radially inward bias of the elongated sleeve, and

wherein the first diameter is smaller than a diameter of the prosthetic device supported on the delivery apparatus and wherein the second diameter is at least equal to the diameter of the prosthetic device supported on the delivery apparatus.

2. The introducer sheath of claim 1, wherein the lumen of the elongated sleeve is configured to return to a diameter smaller than the second diameter after passage of the prosthetic device supported on the delivery apparatus through the lumen.

3. The introducer sheath of claim 1, wherein the first diameter is less than 4 mm and wherein the second diameter is equal to or larger than 4 mm.

4. The introducer sheath of claim 1, wherein the lattice of the inner layer includes a braided layer.

5. The introducer sheath of claim 4, wherein the braided layer includes a braided polymeric layer.

6. The introducer sheath of claim 4, wherein the braided layer includes alternating windings forming a cross-hatch pattern.

7. The introducer sheath of claim 4, wherein the braided layer is constructed of a PEEK, nylon or polypropylene.

8. The introducer sheath of claim 1, wherein the inner layer comprises a laser cut tube.

9. The introducer sheath of claim 1, wherein the outer layer is constructed of a urethane.

10. The introducer sheath of claim 1, the elongated sleeve further including a hydrophilic coating extending over an outer surface of the outer layer.

11. The introducer sheath of claim 1, further comprising at least one sealing valve disposed in the handle, wherein the sealing valve is configured to engage an outer surface of the delivery apparatus as the delivery apparatus is inserted into and through the handle.

12. The introducer sheath of claim 1, further comprising an adjustment mechanism and at least one pull wire, wherein the adjustment mechanism is coupled to the proximal end of the sheath and a proximal end of the pull wire is connected to the adjustment mechanism and extends distally along the sheath.

13. The introducer sheath of claim 12, wherein the inner layer defines at least one side lumen and wherein the pull wire extends within the side lumen.

14. The introducer of claim 1, wherein a difference between the second diameter and the first diameter is at least 6 mm.

15. The introducer of claim 1, wherein the prosthetic device is a stent-mounted prosthetic heart valve.

16. An introducer sheath for passage of a prosthetic device supported on a delivery apparatus, the introducer sheath comprising:

an elongated sleeve including a proximal end and a distal end and defining a lumen extending from the proximal end to the distal end of the elongated sleeve, the elongated sleeve having a resilient, radially inward bias configured to radially contract under its own resiliency;

the elongated sleeve further including at least an inner layer and an outer layer,

the inner layer including a lattice defining a pattern of openings and extending between the proximal and distal ends of the elongated sleeve, and the outer layer extending around the inner layer; and

an adjustment mechanism and at least one pull wire, wherein the adjustment mechanism is coupled to the proximal end of the sheath and a proximal end of the pull wire is connected to the adjustment mechanism and extends distally along the sheath;

wherein the elongated sleeve is radially expandable from a first diameter of the lumen to a second diameter of the lumen against the resilient, radially inward bias of the elongated sleeve;

wherein the first diameter is smaller than a diameter of the prosthetic device supported on the delivery apparatus and wherein the second diameter is at least equal to the diameter of the prosthetic device supported on the delivery apparatus;

an adjustment mechanism and at least one pull wire, wherein the adjustment mechanism is coupled to the proximal end of the sheath and a proximal end of the pull wire is connected to the adjustment mechanism and extends distally along the sheath;

wherein the inner layer defines at least one side lumen and wherein the pull wire extends within the side lumen; and

wherein a distal end of the pull wire is coupled to the lattice near the distal end of the elongated sleeve and wherein proximal movement of the adjustment mechanism pulls on the pull wire and expands the lattice to radially expand the elongated sleeve.

17. The introducer sheath of claim 16, wherein distal movement of the adjustment mechanism releases tension on the pull wire permitting the sleeve to resiliently, radially contract.

18. A method of introducing a delivery apparatus for a prosthetic device into a blood vessel of a patient, the method comprising:

positioning an introducer sheath comprising a handle and an elongate sleeve having a proximal end connected to the handle and a distal end, a lumen therethrough, and an inner layer and an outer layer, in a blood vessel of a patient;

inserting a distal end portion of a delivery apparatus supporting a prosthetic device through the handle and into the lumen at the proximal end of the sleeve;

advancing the distal end portion of the delivery apparatus and the prosthetic device through the lumen of the sleeve from the proximal end to the distal end of the sleeve; and

radially expanding the lumen of the sleeve from a first diameter smaller than a diameter of the prosthetic device supported on the delivery apparatus to a second diameter at least equal to the diameter of the prosthetic device supported on the delivery apparatus to allow passage of the prosthetic device through the lumen;

wherein radially expanding the lumen of the sleeve includes expanding the inner and outer layers of the sleeve, including expanding a lattice of the inner layer of the sleeve, and returning the lumen of the sleeve to a diameter smaller than the second diameter after advancing the prosthetic device supported on the delivery apparatus through the lumen so as to minimize occlusion of the blood vessel.

19. The method of claim 18, wherein the first diameter is less than 4 mm and wherein the second diameter is equal to or larger than 4 mm.

20. The method of claim 18, wherein radially expanding from the first diameter to the second diameter includes radially expanding the sleeve at least 6 mm in diameter.

21. The method of claim 18, further comprising engaging an outer surface of the delivery apparatus with a sealing valve housed within the handle as the delivery apparatus is inserted through the handle.

22. A method of introducing a delivery apparatus for a prosthetic device into a blood vessel of a patient, the method comprising:

positioning an introducer sheath comprising an elongate sleeve having a proximal end and a distal end, a lumen therethrough, and an inner layer and an outer layer, in a blood vessel of a patient;

advancing a delivery apparatus supporting a prosthetic device through the lumen of the sleeve; and

radially expanding the lumen of the sleeve from a first diameter smaller than a diameter of the prosthetic device supported on the delivery apparatus to a second diameter at least equal to the diameter of the prosthetic device supported on the delivery apparatus to allow passage of the prosthetic device through the lumen;

wherein radially expanding the lumen of the sleeve includes expanding the inner and outer layers of the sleeve, including expanding a lattice of the inner layer of the sleeve, and returning the lumen of the sleeve to a diameter smaller than the second diameter after advancing the prosthetic device supported on the delivery apparatus through the lumen so as to minimize occlusion of the blood vessel; and

wherein radially expanding from the first diameter to the second diameter includes pulling on a pull wire coupled to the lattice of the inner layer.

23. The method of claim 22, further comprising radially contracting the sleeve by releasing the pull wire.

24. The method of claim 22, wherein the prosthetic device is a stent-mounted prosthetic heart valve.