Valve introducers with adjustable deployment mechanism and implantation depth gauge

• US 10,376,362 B2
• Filed: 04/05/2012
• Issued: 08/13/2019
• Est. Priority Date: 04/05/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Costello, Declan, Rogers, Ronan, Sheahan, Edmond, Carr, Damian
• Primary Examiner(s): Dang, Phong Son H
• Application Number:
  US13/440,967
• Publication Number:
  US 20130268065A1
• Time in Patent Office: 2,686 Days
• Field of Search: 623 211
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0065 telescopic
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

Valve introducer systems and methods for implanting heart valve prostheses are disclosed, where a valve introducer includes an adjustable deployment mechanism comprising a deployment element and an implantation depth controlling element having a distal end and an adjustable length. The valve introducer also includes a tubular member having a distal end, configured to deliver a heart valve prosthesis, and a length extending from a fixed reference point. The implantation depth controlling element can comprise an inner and an outer cylinder, such as where the outer cylinder has interior threads, and the inner cylinder has exterior threads. The adjustable deployment element can include a depth gauge, wherein the depth gauge indicates the length the tubular member extends beyond a fixed reference point. In certain embodiments, the adjustable deployment element can also be configured to be secured to a cannula.

Claims

1. A valve introducer system comprising a valve introducer, the valve introducer comprising:

a tubular element configured to deliver a heart valve prosthesis, wherein the tubular element includes an outer shaft configured to house a heart valve prosthesis therein and an inner shaft, the tubular element having a length extending from a fixed reference point on the valve introducer to a distal end of the tubular element such that the inner shaft has a inner shaft length from the fixed reference point to a distal end of the inner shaft attached to a nosecone and the outer shaft has an outer shaft length from the fixed reference point to an outer shaft distal end; and

an adjustable deployment mechanism comprising;

a deployment element configured to move the outer shaft relative to the inner shaft upon actuation of the deployment element to uncover a heart valve prosthesis configured to be disposed within the outer shaft; and

an implantation depth controlling element having a distal end and an adjustable length, wherein the implantation depth controlling element is configured such that adjusting the length of the implantation depth controlling element changes the length of the inner shaft with the nosecone attached thereto from the fixed reference point to the distal end of the inner shaft and changes the length of the outer shaft from the fixed reference point to the distal end of the outer shaft, wherein the inner shaft, outer shaft, and the implantation depth controlling element are configured such that adjustment of the implantation depth controlling element does not uncover a heart valve prosthesis disposed within the outer shaft.

2. The valve introducer of claim 1, wherein the implantation depth controlling element comprises:

an outer cylinder; and

an inner cylinder, wherein the outer cylinder and the inner cylinder share a common longitudinal axis,

wherein the outer cylinder and the inner cylinder are configured to be twisted in opposite directions relative to each other to increase or decrease the length of the implantation depth controlling element.

3. The valve introducer of claim 2, wherein the outer cylinder has interior threads, and

the inner cylinder has exterior threads which mate with the interior threads of the outer cylinder.

4. The valve introducer of claim 1, wherein the adjustable deployment mechanism further comprises a depth gauge, wherein the depth gauge indicates the length the tubular element extends beyond the fixed reference point.

5. The valve introducer of claim 1, wherein the adjustable deployment mechanism further comprises a spring configured to provide tactile feedback to the deployment element during deployment of the heart valve prosthesis.

6. The valve introducer of claim 1, wherein the adjustable deployment mechanism further comprises a cannula engagement surface.

7. The valve introducer of claim 6, wherein the cannula engagement surface comprises a locking mechanism configured to couple the adjustable deployment mechanism to a cannula such that the tubular element extends through the cannula.

8. The valve introducer system of claim 1, further comprising a cannula, the cannula comprising a fastening element configured to couple the cannula to an outside surface of an aorta, wherein the tubular element extends through the cannula.

9. A method of implanting a heart valve prosthesis with a valve introducer, the valve introducer comprising:

a tubular element configured to deliver a heart valve prosthesis, wherein the tubular element includes an outer shaft and an inner shaft, the tubular element having a first length extending from a fixed reference point on the valve introducer to a distal end of the outer shaft and a second length extending from the fixed reference point to a distal end of the inner shaft; and

an adjustable deployment mechanism comprising;

a deployment element; and

an implantation depth controlling element having a distal end and an adjustable length; and

the method comprising;

adjusting the length of the implantation depth controlling element of the valve introducer to adjust the first length and the second length of the tubular element from the fixed reference point to the distal end of outer shaft and the distal end of the inner shaft, respectively, such that the tubular element of the valve introducer will extend a predetermined depth from a predetermined insertion point through a wall of an aorta to a predetermined implantation site within the aorta;

loading the heart valve prosthesis into a capsule at the distal end of the tubular member;

inserting the tubular member of the valve introducer into the aorta to thereby deliver the heart valve prosthesis to the predetermined implantation site;

activating the deployment element to move the outer shaft relative to the inner shaft to deploy the heart valve prosthesis; and

removing the tubular member from the aorta.

10. The method of claim 9, wherein the implantation depth controlling element comprises an outer cylinder with interior threads and an inner cylinder with exterior thread, wherein the outer cylinder and the inner cylinder share a common longitudinal axis, and wherein the step of adjusting the length of the implantation depth controlling element comprises twisting the outer cylinder and the inner cylinder in opposite directions relative to each other about the common longitudinal axis.

11. The method of claim 9, further comprising locking the implantation depth controlling element after adjusting the length.

12. The method of claim 9, further comprising fastening a cannula to an outside surface of the aorta and coupling the valve introducer with the cannula such that the tubular member extends through the cannula and into the aorta through the insertion point.

13. The method of claim 9, further comprising using medical imaging to calculate the depth between the insertion point and the implantation site.

14. The method of claim 9, further comprising displaying the depth the tubular element will extend into the aorta on a depth gauge disposed on the implantation depth controlling element.

15. The method of claim 9, further comprising using medical imaging to locate the distal end of the tubular element within the aorta prior to deployment of the heart valve prosthesis.

16. The method of claim 9, further comprising adjusting the implantation depth controlling element after the tubular element is within the aorta.

17. The method of claim 9, further comprising placing a valve at an insertion point on the aorta to prevent blood from escaping the body.

18. The method of claim 9, further comprising placing a patient under extracorporeal circulation.

19. The method of claim 9, wherein the heart valve prosthesis is self-expanding.

20. The method of claim 9, further comprising inflating a balloon to expand the heart valve prosthesis upon deployment.