SYSTEM, DEVICE, AND METHOD FOR PROVIDING ACCESS IN A CARDIOVASCULAR ENVIRONMENT

• US 20100063363A1
• Filed: 08/10/2009
• Published: 03/11/2010
• Est. Priority Date: 02/10/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hamman, Baron L.
• Granted Patent: US 8,574,257 B2
• Time in Patent Office: Days
• US Class Current: 600/205
• 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 for surgical procedures, comprising;

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

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 wall of an organ while in the compressed state, and wherein the expandable element is further operable to be deployed once it is within the organ to convert to the expanded state;

a stop-grip mechanism disposed on the exterior of the sheath proximal to the expandable element including a grip member positioned distally and movable over the sheath and adapted to apply a biased resistive force across the organ wall in opposition to the expandable element in its expanded state; 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 4, wherein the device valve and sump element are removable from the sheath, and further including a tubular cutter sized to pass along the exterior of the sheath to the organ 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 grip member slides freely along the sheath, and the stop-grip mechanism further includes an internally-threaded stop member controllably movable along external threads on the sheath, and a spring mechanism in between the grip member and stop member that provides the biased resistive force.

8. 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.

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

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

11. The access port of claim 9, wherein the braided structure is expanded by applying linear compression thereto.

12. A method of surgery on a heart, comprising:

providing an access port having an elongated sheath, an expandable element at a distal end thereof, and a device valve at a proximal end;

forming an incision in a heart chamber wall;

passing the expandable element through the heart chamber wall while in a compressed state;

deploying the expandable element once it is within the organ such that it is in an expanded state;

advancing a grip member distally along the sheath to provide a resistive force across the heart chamber wall in opposition to the expandable element in its expanded state, thus securing the access port to the heart chamber wall; and

performing placement, manipulation, or repair of a heart valve by extending tools through the device valve and sheath lumen into the heart chamber.

13. The method of claim 12, wherein the grip member is arranged to slide freely along the sheath, the access port further including a stop member controllably movable along the sheath, and a spring mechanism in between the stop member and grip member, the method including controllably moving the stop member in a distal direction so that the grip member exerts a spring-biased resistive force in opposition to the expandable element.

14. The method of claim 12, further including mating threads provided on the exterior of the sheath and on the interior of the stop member.

15. The method of claim 12, further including a sump element on a proximal end of the sheath which operates to exhaust air bubbles present in the sheath.

16. The method of claim 12, further including removing the device valve from the sheath.

17. The method of claim 16, further including:

passing a tubular cutter along the exterior of the sheath to the heart chamber wall;

cutting a circular hole in the heart chamber wall;

securing a valve conduit to the hole;

manipulating the expandable element such that it is in the compressed state;

and removing the expandable element from the hole and the access port from within the valve conduit.

18. The method of claim 17, further comprising advancing the cutter element along the sheath by rotating the cutter element along a threaded portion thereof.

19. The method of claim 16, further including, prior to removing the device valve from the sheath, advancing an obturator on a shaft through the device valve and into the sheath lumen, the obturator being sized to form a seal with the inner lumen of the sheath.

20. The method of claim 19, wherein the obturator has external threads that mate with internal threads on the sheath lumen.