Extractable cardiac probe and its application procedure

• US 5,383,924 A
• Filed: 06/03/1993
• Issued: 01/24/1995
• Est. Priority Date: 06/03/1992
• Status: Expired due to Term

• Current Assignee: Ela Medical S.A. (LivaNova Plc)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Brehier, Jacques
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/071,675
• Time in Patent Office: 600 Days
• Field of Search: 607/115, 607/116, 607/119, 607/120, 607/122, 607/125-132, 128/642
• US Class Current: 607/126
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

An extractable cardiac probe comprising a catheter (4) and a sleeve (3) that is at least partially deformable and mountable to the catheter. The procedure for application of the extractable probe uses an extractor device (11) equipped to pass between the sleeve and catheter to deform the sleeve (3) elastically to permit removal and replacement of the catheter.

Claims

1. An extractable cardiac probe for cardiac stimulation, comprising:

a catheter having a proximal tip, a distal tip, and having a flexible outer sheath, and an electrode at the distal tip adapted to be placed against an inner surface of a heart; and

a sleeve surrounding said catheter having a proximal tip, a distal tip, and means for attachment of the probe to a cardiac surface,

said catheter being separable from said sleeve to permit the withdrawal of the catheter and the retention in position of the sleeve on the cardiac surface, wherein said sleeve has an inside diameter that securely engages the catheter, the sleeve being at least partially deformable through enlargement of the inside diameter to permit separation of the catheter and the sleeve and extraction of the catheter from the sleeve by sliding movement.

2. The probe in accordance with claim 1, wherein the sleeve proximal tip further comprises a shaped part to receive a separator device.

3. The probe in accordance with claim 2, wherein the shaped part is an appreciably cylindrical part having a proximal end adapted to receive a tubular separating device between the sleeve and the catheter.

4. The probe in accordance with claim 2 wherein the sleeve inside diameter and the catheter further comprise respective interacting shapes so that the sleeve and catheter interlock to securely attach to one another.

5. The probe in accordance with claim 4 wherein the respective interacting shapes further comprise a groove interacting with a retention ring.

6. The probe in accordance with claim 4 wherein the respective interacting shapes further comprise a boss interacting with a recess.

7. The probe in accordance with claim 4 wherein the sleeve further comprises an appreciably non-deformable component at its distal tip.

8. The probe in accordance with claim 7 wherein the non-deformable component is a retention ring of a radiopaque material.

9. The probe in accordance with claim 2 wherein the catheter further comprises, in the vicinity of its distal tip, a retention insert attached to the flexible sheath.

10. The probe in accordance with claim 9 wherein the retention insert is a tube of a radiopaque material.

11. The probe in accordance with claim 2 wherein the shaped part further comprises a frustroconical section having proximal and distal ends, the proximal end having a larger diameter than the distal end.

12. The probe in accordance with claim 1 wherein the sleeve inside diameter and the catheter further comprise respective interacting shapes so that the sleeve and catheter lockingly engage one another.

13. The probe in accordance with claim 12 wherein the respective interacting shapes further comprise a groove interacting with a retention ring.

14. The probe in accordance with claim 12 wherein the respective interacting shapes further comprise a boss interacting with a recess.

15. The probe in accordance with claim 1, wherein the sleeve further comprises an appreciably non-deformable component at its distal tip.

16. The probe in accordance with claim 15, wherein said non-deformable component is a retention ring of radiopaque material.

17. The probe in accordance with claim 1, wherein the catheter comprises, in the vicinity of its distal tip, a retention insert attached to the flexible sheath (13).

18. The probe in accordance with claim 17, wherein said retention insert is a tube of radiopaque material.

19. An extractable probe system for providing a replaceable cardiac stimulation catheter for stimulating cardiac tissue comprising:

a catheter having a proximal end, a distal end, an electrode at the distal end, and a flexible outer sheath, the outer sheath having a first surface area at the distal end and a maximum outer diameter; and

a sleeve having a retention burr and an elasticly deformable inner surface, the inner surface having a rest condition and an expanded condition, the sleeve being selectively mounted on the catheter so that the inner surface in the rest condition engages at least a portion of the first surface area of the catheter and the retention burr will maintain the electrode in contact with cardiac tissue, and so that the inner surface in the expanded condition has an inner diameter that is larger than the maximum outer diameter of the catheter, whereby the catheter may be removed from the sleeve by sliding movement.

20. The system of claim 19 wherein the sleeve inner surface further comprises a projection and wherein the catheter distal end further comprises a retention element, the projection being spaced on the catheter proximal end side of the retention element when the sleeve inner surface is engaged with the catheter first surface area.

21. The system of claim 20 wherein the sleeve further comprises a distal end and a retention ring at the distal end.

22. The system of claim 21 wherein the sleeve retention ring and the catheter retention element each further comprise a radiopaque material.

23. The system of claim 19 wherein the portion of the first surface area and the sleeve inner surface further comprise interlocking complementary shapes.

24. The system of claim 23 wherein the interlocking complementary shapes comprise a boss and a recess, one of which is in the first surface area and the other of which is in the sleeve inner surface.

25. The system of claim 23 wherein the interlocking complementary shapes comprise a groove and a retention ring, one of which is in the first surface area and the other of which is in the sleeve inner surface.

26. The system of claim 19 further comprising a separating element about said catheter having a distal tip and an inner diameter, the inner diameter being dimensioned to permit the separating element to slide along the catheter and the distal tip being dimensioned to pass between the sleeve and the catheter as the separating element is passed along the catheter, thereby to place the sleeve inner surface in the expanded condition.

27. The system of claim 26 wherein the sleeve inner surface further comprises a projection and wherein the catheter distal end further comprises a retention element, the projection being spaced on the catheter proximal end side of the retention element when the sleeve inner surface is engaged with the catheter first surface area.

28. The system of claim 27 wherein the sleeve further comprises a distal end and a retention ring at the distal end.

29. The system of claim 28 wherein the separating element distal tip further comprises a ring of radiopaque material, and wherein the sleeve retention ring and the catheter retention element each further comprise a radiopaque material.

30. The system of claim 26 wherein the portion of the first surface area and the sleeve inner surface in the rest condition further comprise complementary shapes biased in interlocking contact.

31. The system of claim 30 wherein the interlocking complementary shapes comprise a boss and a recess, one of which is in the first surface area and the other of which is in the sleeve inner surface.

32. The system of claim 30 wherein the interlocking complementary shapes comprise a groove and a retention ring, one of which is in the first surface area and the other of which is in the sleeve inner surface.

33. A method of providing a probe for use in stimulating cardiac tissue comprising the steps of:

(a) providing a catheter with a flexible outer sheath having a maximum outer diameter, a distal end, a proximal end, an electrode at the distal end for contacting cardiac tissue, and a first contacting surface located near the distal end proximal of the electrode;

(b) providing a sleeve with an inner surface and an outer surface, the outer surface having at least one retention burr projecting outwardly, the inner surface being deformable and having a rest condition and an expanded condition, the expanded condition having an inner diameter that is greater than the maximum outer diameter of the catheter outer sheath;

(c) mounting the sleeve over the catheter with the sleeve inner surface in the rest condition in locking engagement with the catheter first surface; and

(d) positioning the mounted sleeve and catheter so that the catheter electrode is in touching contact with the cardiac tissue to be stimulated and maintaining the electrode in said position for a time sufficient to permit fibrin to grow over the retention burr, thereby to secure the catheter electrode in place.

34. The method of claim 33 wherein step (b) further comprises providing the sleeve inner surface with a proximal end having a diameter that is greater than the maximum outer diameter of the catheter in the rest condition.

35. The method of claim 33 further comprising:

(e) providing a separator having a distal tip and an inner diameter passageway that is greater than the maximum outer diameter of the catheter outer sheath;

(f) placing the separator around the catheter and sliding the separator along the catheter so that the separator distal tip passes between the sleeve inner surface and the first surface of the catheter, thereby placing the inner surface in the expanded condition; and

(g) removing the catheter from contact with the cardiac tissue using traction so that the separating device remains in contact with the sleeve inner surface and the sleeve remains in contact with the grown fibrin.

36. The method of claim 35 wherein step (g) further comprises applying a traction force that is less than about 1 Newton.

37. The method of claim 35 further comprising the step of inserting a second catheter proximate to the cardiac tissue by passing it through the inner passageway of the separator.

38. The method of claim 37 wherein the inserting step further comprises inserting a second catheter other than a cardiac stimulating catheter for performing a medical procedure other than cardiac stimulation.

39. The method of claim 37 wherein the inserting step further comprises inserting a cardiac stimulating catheter having a first surface area and an electrode so that the electrode is in touching contact with the cardiac tissue to be stimulated, and removing the separator by sliding along the second catheter so that the sleeve inner surface returns to its rest condition and lockingly engages the first surface area of the second catheter.

40. A probe for providing stimulating pulses to cardiac tissue comprising:

a catheter having a flexible outer sheath, a distal end, and an electrode at the distal end;

a sleeve having an outer surface on which fibrin may develop and a deformable elastic inner surface, the sleeve being mounted on the catheter with at least a portion of the deformable elastic inner surface frictionally engaged with a portion of the catheter outer sheath, wherein the sleeve deformable elastic inner surface is enlargeable to a diameter that will permit extraction of the catheter by sliding.

41. The probe of claim 40 wherein the sleeve inner surface has a proximal end and a distal end, and the proximal end has an outer diameter that is greater than the flexible outer sheath.

42. The probe of claim 40 wherein the sleeve inner surface has a first shape and the catheter sheath has a second shape opposite the first shape when the sleeve is mounted on the catheter, the first and second shapes providing locking engagement between the catheter and the sheath.