Intracardiac sheath stabilizer

• US 8,876,712 B2
• Filed: 07/28/2010
• Issued: 11/04/2014
• Est. Priority Date: 07/29/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yee, Kristopher, Duhay, Francis G., Miraki, Manouchehr
• Primary Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US12/845,584
• Publication Number:
  US 20110028797A1
• Time in Patent Office: 1,560 Days
• Field of Search: 248/75, 248/157, 248/160, 248419-430, 600/102, 600/114, 600201-246
• US Class Current: 600/231
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/0237 for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms

Abstract

A surgical stabilizer for use with a surgical site retractor has a base, a bendable arm, and a distal cuff adapted to resiliently hold a tube of an elongated port-access device. The cuff may have a body defining a partial enclosure within which is held a highly flexible gasket having a slit for resiliently receiving the tube. The surgical site retractor may have a collapsible ring and a flexible outer portion attached thereto, the ring being sized to pass through an intercostal incision and expand therein under adjacent ribs to prevent removal, and the flexible outer portion extending out of the incision and drawing over the stabilizer base to mutually secure the retractor and base. The port-access tube may be for a heart valve delivery system using an elongated port-access device for transapically delivering a prosthetic heart valve to the aortic valve annulus. A method involves partly installing the surgical site retractor, anchoring the base of the stabilizer with the flexible outer portion, deploying the port-access tube from outside the body through the incision and through a puncture in the heart wall, and resiliently capturing a tube of the port-access within the partial enclosure of the stabilizer cuff. A second bendable arm on the base having a clip may be used to hold still a proximal end of the port-access device.

Claims

1. A surgical stabilizer for use with a surgical site retractor and an elongated port-access device having a tube, comprising:

a base defining a periphery having a size that enables it to be held against an exterior chest wall by the surgical site retractor and around an intercostal chest incision with the base extending over a first rib on a first side of the intercostal chest incision while simultaneously extending over a second rib on a second side of the intercostal chest incision, wherein the first side is opposite to the second side;

a first arm attached to and extending away from the base and capable of being bent into and retaining a variety of shapes; and

a distal cuff attached to the first arm opposite the base, the cuff having a stiff C-shaped partial ring and a flexible gasket held across an area defined within the C-shaped partial ring, the gasket having a slit directed toward an open mouth of the C-shaped partial ring, the open mouth being sized larger than the tube of the port-access device such that the cuff can be pressed around the tube, or vice versa, with the tube entering the slit and being resiliently held by the gasket.

2. The stabilizer of claim 1, wherein the cuff gasket defines an inner aperture smaller than the C-shaped partial ring, the slit connecting to the inner aperture.

3. The stabilizer of claim 1, wherein the cuff C-shaped partial ring includes a C-shaped lower member attached to a C-shaped upper member, and the gasket is sandwiched therebetween.

4. The stabilizer of claim 1, wherein the base defines a C-shaped body with an upper face and a concave lower contact face.

5. The stabilizer of claim 4, wherein the C-shaped body has an outer surface of soft polymer and includes an inner malleable member able to conform to three-dimensional surfaces.

6. A surgical stabilizer for use with a flexible ring-shaped surgical site retractor and an elongated port-access device having a tube, comprising:

a base defining a periphery having a size that enables it to be held against an exterior chest wall by the flexible ring-shaped surgical site retractor and around an intercostal chest incision with the base extending over a first rib on a first side of the intercostal chest incision while simultaneously extending over a second rib on a second side of the intercostal chest incision, wherein the first side is opposite to the second side, the base comprising a semi-circular C-shaped portion configured to encircle most of the chest incision and to lie on top of the flexible ring-shaped surgical site retractor;

a first arm attached to and extending away from the base and capable of being bent into and retaining a variety of shapes; and

a distal cuff attached to the first arm opposite the base, the cuff configured to receive and resiliently hold a tube therein.

7. The stabilizer of claim 6, wherein the cuff comprises a stiff C-shaped partial ring and a flexible gasket held across an area defined within the C-shaped partial ring, the gasket having a slit directed toward an open mouth of the C-shaped partial ring, the open mouth being sized larger than the tube of the port-access device such that the cuff can be pressed around the tube, or vice versa, with the tube entering the slit and being resiliently held by the gasket.

8. The stabilizer of claim 7, wherein the cuff gasket defines an inner aperture smaller than the C-shaped partial ring, the slit connecting to the inner aperture.

9. The stabilizer of claim 7, wherein the cuff C-shaped partial ring includes a C-shaped lower member attached to a C-shaped upper member, and the gasket is sandwiched therebetween.

10. The stabilizer of claim 6, wherein the base defines a malleable C-shaped body with an upper face and a concave lower face.

11. The stabilizer of claim 10, wherein the C-shaped body is formed as a single unitary body.

12. The stabilizer of claim 10, wherein the C-shaped body has an outer surface of soft polymer and includes an inner malleable member able to conform to three-dimensional surfaces.

13. The stabilizer of claim 6, wherein the stabilizer base includes a C-shaped raised lip around an inner edge surrounding the open area.

14. The stabilizer of claim 13, wherein the raised lip is formed by a C-shaped adapter removably attached to an upper surface of the base.