Transapical mini-introducer hemostasis valve and punch

• US 10,278,728 B2
• Filed: 01/29/2010
• Issued: 05/07/2019
• Est. Priority Date: 01/30/2009
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical LLC (Abbott Laboratories)
• Inventors: Chalekian, Aaron J.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US13/146,789
• Publication Number:
  US 20110282287A1
• Time in Patent Office: 3,385 Days
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/346 with wings
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

An introducer for providing access to the interior of the heart generally includes a valve, a shaft, and a piercing element. The valve has a substantially closed state in the absence of an instrument inside the valve and an open state in the presence of the instrument inside the valve. The shaft has first and second ends. The piercing element is located at the first end of the shaft. The shaft is removably positioned inside the valve in an assembled condition. The valve is dimensioned to receive the instrument therein upon removal of the shaft from the valve.

Claims

1. An introducer for providing access to the heart, comprising:

a tubular body extending continuously from an entrance end to an exit end;

a valve assembled in the body, the valve having a substantially closed state in the absence of an instrument inside the valve and an open state in the presence of the instrument inside the valve;

an annular rib at the exit end of the body and configured to secure the body to the heart, the annular rib having a circumference of the same size in both the closed state of the valve and in the open state of the valve;

a shoulder positioned between the exit end of the body and the entrance end of the body, the shoulder being at a first spaced distance from the exit end of the body and at a second spaced distance from the entrance end of the body, the second spaced distance being greater than the first spaced distance;

a shaft having a first end and a second end; and

a piercing element at the first end of the shaft, the shaft being positioned inside the valve in an assembled condition so that the shaft and the valve may be inserted together through tissue of the heart, in the assembled condition the piercing element being exposed for use beyond the exit end of the body and the second end of the shaft being at the entrance end of the body so that the distance between the second end of the shaft and the shoulder is greater than the first spaced distance, and the valve being dimensioned to receive the instrument therein upon removal of the shaft from the valve.

2. The introducer according to claim 1, further comprising a grasping member connected to the second end of the shaft.

3. The introducer according to claim 1, wherein the shoulder is at the entrance end of the body.

4. The introducer according to claim 1, wherein the piercing element includes a plurality of blades.

5. The introducer according to claim 1, wherein the valve includes a plurality of flaps resiliently movable between a substantially closed position in the absence of the instrument inside the valve and an open position in the presence of the instrument inside the valve.

6. The introducer according to claim 5, wherein the flaps collectively define a cross-shaped slit in the substantially closed position.

7. The introducer according to claim 1, wherein the body has a length, and the shaft has a length which is substantially the length of the body.

8. The introducer according to claim 1, wherein the body has a length, and the shaft has a length which is greater than the length of the body.

15. The introducer according to claim 1, further comprising a detent release mechanism for holding the shaft in assembled relationship to the body.

9. An introducer for providing access into a heart, comprising:

a tubular body having an entrance end, an exit end, and an annular rib at the exit end, the annular rib being configured to secure the body to the heart;

a valve assembled in the body, the valve including flaps movable between a substantially closed position in the absence of an instrument inside the valve and an open position in the presence of the instrument inside the valve, the flaps in the closed position collectively defining substantially a plane, the annular rib having a circumference of the same size in both the absence of the instrument inside the valve and in the presence of the instrument inside the valve;

a shoulder at a spaced distance from the exit end of the body and positioned between the entrance end of the body and the exit end of the body;

a shaft having a first end and a second end; and

a punch at the first end of the shaft;

the shaft being positioned inside the valve in an assembled condition so that the shaft and the valve may be inserted together through tissue of the heart, in the assembled condition the punch being exposed for use beyond the exit end of the body and the distance between the second end of the shaft and the shoulder being greater than the spaced distance.

10. The introducer according to claim 9, further comprising a ring connected to the second end of the shaft.

11. The introducer according to claim 9, wherein the punch includes a plurality of blades.

12. The introducer according to claim 9, wherein the flaps collectively define a cross-shaped slit in the substantially closed position.

13. The introducer according to claim 9, wherein the body has a length, and the shaft has a length which is substantially the length of the body.

14. The introducer according to claim 9, wherein the body has a length, and the shaft has a length which is greater than the length of the body.