Suture-free clamp and sealing port and methods of use

• US 6,443,957 B1
• Filed: 10/17/2000
• Issued: 09/03/2002
• Est. Priority Date: 12/11/1998
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: Addis, Bruce
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/691,386
• Time in Patent Office: 686 Days
• Field of Search: 606/108, 604/174, 604/177, 604/178
• US Class Current: 606/108
• CPC Class Codes: A61B 17/3421 Cannulas
• 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 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3492 against the outside of the body

Abstract

A suture-free clamp for sealing body tissue during introduction of medical devices, such as a cannula, aspirator, stent, endoscope, and pressure monitor. The clamp may be used in a patient'"'"'s vascular tissues, such as the right atrium and the aorta. The clamp comprises a generally cone-shaped housing which includes a lumen for receiving a medical device, and a collar having a central opening for passage of a medical device, the collar connected to a proximal end of the housing by a plurality of struts. The proximal end of the housing and the collar each has an annular surface. The two surfaces are opposed, and are operable to clamp tissue therebetween, and to thereafter release the tissue by releasing the clamp. Methods are also disclosed for using the suture-free clamp for sealing body tissues during introduction of a medical device.

Claims

1. A clamp for introduction of a medical device, comprising:

a housing having an outer surface, a proximal end, a distal end, and a lumen therebetween, the lumen adapted to receive a medical device for introduction through body tissues; and

a collar that releasably engages the proximal end of the housing, the collar having a central opening aligned with the lumen of the housing for passage of the medical device, and a surface operable to clamp tissue between the collar and the housing.

2. The clamp of claim 1, wherein the housing is a generally cone-shaped housing, wherein the diameter of the proximal end is larger than the diameter of the distal end, and wherein the outer surface of the housing is generally smooth and tapered from the proximal to the distal end, the proximal end of the housing having an annular surface that lies in a plane substantially perpendicular to the longitudinal axis of the lumen.

3. The clamp of claim 2, wherein the collar is operably connected to the proximal end of the housing by connecting members, the collar having an annular surface that surrounds the opening and is operable to engage the annular surface of the housing to clamp tissue therebetween, and thereafter release the tissue by releasing the clamp.

4. The clamp of claim 3, wherein the connecting member comprises a plurality of struts.

5. The clamp of claim 4, wherein the struts are pivotally connected to the housing and the collar.

6. The clamp of claim 5, wherein the struts have a pivoting internal joint.

7. The clamp of claim 3, wherein the housing includes a plurality of distally extending slots.

8. The clamp of claim 7, wherein the struts are located and operate within the slots.

9. The clamp of claim 3, further comprising a medical device, wherein the medical device is a cannula which is received through the lumen of the housing and extends proximally through the opening of the collar.

10. The clamp of claim 3, wherein the lumen of the housing further includes a hemostatic valve.

11. The clamp of claim 3, wherein the housing has a length of 0.3-2.0 inches and an outer diameter of 0.4-1.0 inches, and wherein the collar has a length of 0.25-0.75 inches and an outer diameter of 0.4-1.0 inches.

12. A method for introduction of a medical device, comprising the steps of:

providing a clamp comprising a housing having a proximal end, a distal end, and a lumen therebetween, the clamp further comprising a collar that is connectable to the proximal end of the housing, the collar having a central opening aligned with the lumen of the housing;

making an incision in the tissue;

introducing the distal end of the housing through the incision;

operating the collar to engage tissue between the collar and the housing; and

introducing a medical device through the lumen of the housing into the body.

13. The method of claim 12, further comprising the step of providing a clamp comprising a generally cone-shaped housing, the proximal end of the housing having an annular surface that lies in a plane substantially perpendicular to the longitudinal axis of the lumen, the collar being operably connected to the proximal end of the housing by a connecting member, the collar having an annular surface that operates to engage the annular surface of the housing.

14. The method of claim 13, wherein the step of introducing the distal end of the housing through the incision further comprises the step of positioning the tissue against the annular surface of the housing.

15. The method of claim 14, further comprising the step of operating the collar to engage the tissue against the annular surface of the collar, wherein the tissue is clamped between the annular surface of the housing and the annular surface of the collar.

16. The method of claim 15, wherein the connecting member comprises a plurality of struts.

17. The method of claim 15, wherein the tissue is the right atrium.

18. The method of claim 15, wherein the tissue is a vessel.

19. The method of claim 18, wherein the vessel is an artery.

20. The method of claim 18, wherein the artery is the aorta.

21. The method of claim 15, wherein the medical device is a cannula.

22. The method of claim 21, further comprising the step of delivering oxygenated blood to the patient through the cannula.

23. The method of claim 22, further comprising a steps of coronary artery bypass grafting surgery.

24. The method of claim 22, further comprising the steps of valve repair.

25. The method of claim 15, wherein the lumen of the housing further includes a hemostatic valve.

26. The method of claim 15, further comprising the step of releasing the collar to disengage the tissue.

27. The method of claim 26, further comprising the step of removing the housing from the incision.