Tissue Separating Systems and Methods

• US 20080154296A1
• Filed: 12/22/2006
• Published: 06/26/2008
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Reiser, Chris, Coe, Sean, Kennergren, Charles, Taylor, Kevin D., Harlan, Kenneth D.
• Granted Patent: US 9,028,520 B2
• Time in Patent Office: Days
• US Class Current: 606/190
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320056 Tunnelers
• 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

Systems and methods for separating an object such as a pacing lead from a patient tissue involve a flexible and torqueable shaft having an internal lumen sized to receive the object, and a hard separating mechanism for separating the object from the tissue. Typically the shaft and separating mechanism are advanced along or toward the object, and the separating mechanism is contacted with the tissue. The shaft is rotated to effect separation between the object and the tissue. The systems and methods are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Claims

1. A system for separating an object from a patient tissue, comprising:

a sheath having a proximal end and a distal end; and

a cylindrical separator coupled with the distal end of the sheath, the separator having an internal lumen, a proximal end, and a distal end having a separating mechanism;

wherein the separating mechanism comprises an abrasive material.

2. The system according to claim 1, wherein the abrasive material comprises a member selected from the group consisting of a diamond, an aluminum carbide, and a silica carbide.

3. The system according to claim 1, wherein the distal end of the separator defines a plane, and the internal lumen of the separator defines a central longitudinal axis, wherein an acute angle between the plane and the central longitudinal axis is within a range from about 30 degrees to about 85 degrees.

4. The system according to claim 1, wherein the separator comprises a member selected from the group consisting of a cutting member, a dilating member, and a stripping member.

25. The system according to claim 1, 8, 15, 17, or 20, wherein the separating mechanism is configured to separate the object from the patient tissue when the separator is rotated.

5. A system for separating an object from a patient tissue, comprising:

an internal sheath having a proximal end and a distal end;

an external sheath having a proximal end and a distal end;

an internal separator coupled with the distal end of the internal sheath, the internal separator having a first separating mechanism; and

an external separator coupled with the distal end of the external sheath, the external separator having a second separating mechanism;

wherein the internal separator is disposed at least partially within the external separator, and the internal and external separators are configured for relative rotational movement that brings the first separating mechanism and the second separating mechanism together.

6. The system according to claim 5, wherein the internal separator comprises a member selected from the group consisting of an internal cutting member, an internal stripping member, and an internal dilating member, and the external separator comprises a member selected from the group consisting of an external cutting member, an external stripping member, and an external dilating member.

7. The system according to claim 5, wherein the first separating mechanism comprises a member selected from the group consisting of a first cutting blade, a first stripping blade, and a first dilating blade, and the second separating mechanism comprises a member selected from the group consisting of a second cutting blade, a second stripping blade, and a second dilating blade.

8. A system for separating an object from a patient tissue, comprising:

a sheath having a distal end; and

a cylindrical separator comprising;

a distal end having a separating mechanism; and

a proximal end coupled with the sheath distal end;

wherein the distal end of the cylindrical separator defines a plane that is substantially perpendicular to a central longitudinal axis of the cylindrical separator.

9. The system according to claim 8, wherein the sheath comprises a proximal end that is less flexible than the distal end of the sheath.

10. The system according to claim 8, wherein the distal end of the sheath comprises a bending stiffness less than about 6 lb/in.

11. The system according to claim 8, wherein the sheath comprises a torsional transmission of greater than about 0.177 pound-inch.

12. The system according to claim 8, wherein the sheath comprises a braid.

13. The system according to claim 8, wherein the separator comprises a member selected from the group consisting of a cutting member, a stripping member, and a dilating member.

14. The system according to claim 8, wherein the separating mechanism comprises a member selected from the group consisting of a cutting blade, a stripping blade, and a dilating blade.

15. A system for separating an object from a patient tissue, comprising:

a sheath having a proximal end and a distal end; and

a cylindrical separator coupled with the distal end of the sheath, the separator having an internal lumen, a proximal end, and a distal end;

wherein the distal end of the separator defines a plane, and comprises plurality of teeth having separating means in perpendicular alignment with the plane.

16. The system according to claim 15, wherein the internal lumen of the separator defines a central longitudinal axis, and an acute angle between the plane and the central longitudinal axis is within a range from about 30 degrees to about 85 degrees.

17. A system for separating an object from a patient tissue, comprising:

a sheath having a distal end;

a cylindrical separator having a proximal end, a distal end, and an internal lumen that defines a central longitudinal axis;

wherein the proximal end of the separator is coupled to the distal end of the sheath, and the distal end of the separator comprises;

a rim that defines a plane which is not perpendicular to the central longitudinal axis of the separator;

a separating mechanism disposed along a first portion of the rim; and

a blunt edge disposed along a second portion of the rim.

18. The system according to claim 17, wherein the separating mechanism is configured to separate the object from the tissue when the separator is rotated in one direction, but not when the separator is rotated in an opposite direction.

19. The system according to claim 17, wherein the separating mechanism comprises a member selected from the group consisting of a cutting blade, a stripping blade, and a dilating blade.

20. A system for separating an object from a patient tissue, comprising:

a flexible shaft having a proximal end and a distal end; and

a metal separator having a proximal end, a distal end, and an internal lumen that defines a central longitudinal axis;

wherein the proximal end of the separator is coupled to the distal end of the sheath, and the distal end of the separator includes a separating means and defines a plane which is not perpendicular to the central longitudinal axis of the separator.

21. The system according to claim 20, wherein the proximal end of the flexible shaft is less flexible than the distal end of the shaft.

22. The system according to claim 20, wherein the distal end of the flexible shaft comprises a bending stiffness less than about 6 lb/in.

23. The system according to claim 20, wherein the flexible shaft comprises a torsional transmission of greater than about 0.177 pound-inch.

24. The system according to claim 20, wherein the flexible shaft comprises a braid.

26. A system for separating an object from a patient tissue, comprising:

a flexible shaft having a proximal end, a distal end, and an internal lumen having an inner diameter greater than about 0.130 inch, wherein the shaft comprises a bending stiffness of less than about 6 lb/in and a torsional transmission of greater than about 0.177 pound-inch; and

a separator having a proximal end and a distal end;

wherein the proximal end of the separator is coupled to the distal end of the sheath, the distal end of the separator includes a separating mechanism, and the separating mechanism comprises a hardness greater than about B65 Rockwell.

27. A method for separating a patient tissue from an object, comprising:

providing a tool comprising;

a sheath having a proximal end and a distal end; and

a separator operably coupled to the distal end of the sheath, the separator having a proximal end, a distal end that includes a rim, a separating mechanism disposed along a first portion of the rim, a blunt edge disposed along a second portion of the rim, and an internal lumen that defines a central longitudinal axis;

contacting the separating mechanism with patient tissue that is attached to the object; and

rotating the separator so as to separate the tissue from the object with the separating mechanism.

28. The method according to claim 27, wherein the rim defines a plane that is not perpendicular to the central longitudinal axis of the separator.

29. The method according to claim 27, wherein the rim defines a plane that is perpendicular to the central longitudinal axis of the separator.

30. The method according to claim 27, wherein the separating mechanism is configured to separate the tissue from the object when the separator is rotated in one direction, but not when the separator is rotated in an opposite direction.

31. A system for separating an object from a patient tissue, comprising:

a sheath having a distal end;

a cylindrical separator having a proximal end, a distal end, and an internal lumen that defines a central longitudinal axis;

wherein the proximal end of the separator is coupled to the distal end of the sheath, and the distal end of the separator comprises;

a rim that defines a plane;

a separating mechanism disposed along a first portion of the rim; and

a blunt edge disposed along a second portion of the rim.

32. The system according to claim 31, wherein the plane is substantially perpendicular to the central longitudinal axis of the separator.

33. The system according to claim 31, wherein the plane is not substantially perpendicular to the central longitudinal axis of the separator.

34. The system according to claim 31, wherein an acute angle between the plane and the central longitudinal axis is within a range from about 30 degrees to about 85 degrees.