System, device, and method for providing access in a cardiovascular environment

• US 8,574,257 B2
• Filed: 08/10/2009
• Issued: 11/05/2013
• Est. Priority Date: 02/10/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hamman, Baron L.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/538,800
• Publication Number:
  US 20100063363A1
• Time in Patent Office: 1,548 Days
• Field of Search: 606/184, 606191-194, 606197-199, 606/108
• US Class Current: 606/191
• 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 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

A device to be used in a cardiovascular environment, comprising an expandable element that is coupled to a rod and that includes a compressed state and an expanded state. The expandable element is operable to be positioned within a wall of an organ while the expandable element is in the compressed state. The expandable element is further operable to be deployed once it is within the organ such that it is in the expanded state. The device further includes a cutter element operable to make a circular incision at the wall of the organ. The expandable element creates a resistive force when it is pulled against the wall while in the expanded state such that an interface is created for making the incision. The device includes a stop-grip mechanism that maintains the resistive force at the interface. One embodiment features the expandable element being umbrella shaped.

Claims

1. An access port to allow sealed access through a wall of the heart during a beating heart cardiac procedure, comprising;

an elongated tubular sheath having a proximal end, a distal end, and a lumen extending therebetween;

a single expandable element on the tubular sheath, the expandable element being disposed around the distalmost end of the sheath and having a compressed state and an expanded state, wherein the expandable element is operable to be positioned within a chamber of the heart while in the compressed state, and wherein the expandable element is further operable to be deployed once it is within the heart chamber to convert to the expanded state and contact an interior wall of the heart chamber;

a stop-grip mechanism disposed on the exterior of the sheath proximal to the expandable element including a grip member axially movable over the sheath and adapted to contact an exterior wall of the heart chamber and apply a compressive force across the wall in opposition to the expandable element in its expanded state, and a variable position stop member positioned proximal to the grip member and adapted to apply a distal bias to the grip member, wherein the grip member slides freely along the sheath, and the stop member is internally-threaded and controllably movable along external threads on the sheath, and the stop-grip mechanism further includes a spring mechanism in between the grip member and stop member that provides the compressive force; and

a device valve connected to the proximal end of the sheath to allow devices to be placed and removed through the sheath while minimizing blood loss.

2. The access port of claim 1, wherein the device valve includes both a hemostatic valve that closes when no devices are present and a wiper seal that seals around a range of device sizes.

3. The access port of claim 1, further comprising an obturator on the distal end of a shaft, the obturator being sized to form a seal with the inner lumen of the sheath.

4. The access port of claim 1, further comprising a sump element on a proximal end of the sheath which operates to exhaust air bubbles present in the sheath.

5. The access port of claim 1, wherein the device valve is removable from the sheath, and further including a tubular cutter for forming a circular incision sized to pass along the exterior of the sheath to the heart chamber wall.

6. The access port of claim 5, further including mating threads provided on the exterior of the sheath and on the interior of the cutter.

7. The access port of claim 1, wherein the device is sized to allow a sealed access to the left ventricle of a patient for placement, manipulation, or repair of a heart valve through the sheath lumen.

8. The access port of claim 1, wherein the expandable element is a braided structure.

9. The access port of claim 8, wherein the braided structure is coated with an elastomeric membrane.

10. The access port of claim 8, wherein the braided structure is expanded by applying linear compression thereto.

11. An access port to allow sealed access through a wall of the heart during a beating heart cardiac procedure, comprising;

an elongated tubular sheath having a proximal end, a distal end, and a lumen extending therebetween, the sheath having external threads;

an expandable element disposed around the distal end of the sheath having a compressed state and an expanded state, wherein the expandable element is operable to be positioned within a chamber of the heart while in the compressed state, and wherein the expandable element is further operable to be deployed once it is within the heart chamber to convert to the expanded state;

a sealing mechanism disposed on the exterior of the sheath proximal to the expandable element including a grip member axially movable over the sheath and adapted to apply a compressive force across a wall of the heart chamber in opposition to the expandable element in its expanded state;

a device valve connected to the proximal end of the sheath to allow devices to be placed and removed through the sheath while minimizing blood loss; and

a tubular cutter having internal threads and sized to advance along the external threads of the sheath to the heart chamber wall, the cutter having a sharp end for forming a circular incision in the heart chamber wall.

12. The access port of claim 11, wherein the tubular cutter is smaller than the expandable element in its expanded state.

13. The access port of claim 11, wherein the tubular cutter is hollow or concave such that it can incise and retain a circular portion of tissue.

14. The access port of claim 11, wherein the device valve includes both a hemostatic valve that closes when no devices are present and a wiper seal that seals around a range of device sizes.

15. The access port of claim 11, further comprising an obturator on the distal end of a shaft, the obturator being sized to form a seal with the inner lumen of the sheath.

16. The access port of claim 11, wherein the device valve is removable from the sheath to permit the tubular cutter to pass along the exterior of the sheath to the heart chamber wall.

17. The access port of claim 11, wherein the grip member slides freely along the sheath, and wherein the sealing mechanism includes an internally-threaded stop member positioned proximal to the grip member and controllably movable along the external threads on the sheath, and a spring mechanism in between the grip member and stop member that provides the compressive force.

18. The access port of claim 11, wherein the device is sized to allow a sealed access to the left ventricle of a patient for placement of a heart valve through the sheath lumen.

19. The access port of claim 11, wherein the expandable element is a braided structure.