Tissue separating systems and methods

• US 9,028,520 B2
• Filed: 12/22/2006
• Issued: 05/12/2015
• 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: Taylor, Kevin D., Reiser, Chris, Coe, Sean, Harlan, Kenneth D., Kennergren, Charles
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US11/615,005
• Publication Number:
  US 20080154296A1
• Time in Patent Office: 3,063 Days
• Field of Search: 606/190, 606/170, 606/180, 606/108, 606/159
• 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 a pacing lead from a patient tissue, comprising:

a flexible sheath having a distal end;

a handle coupled with the flexible sheath at a position proximal to the distal end of the flexible sheath; and

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 cylindrical separator is coupled to the distal end of the flexible sheath, and the distal end of the cylindrical separator comprises;

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

a separating mechanism disposed in a recess formed in at least a portion of a leading edge of a first portion of the rim, wherein the leading edge faces at least partially in a first direction to separate the patient tissue when the cylindrical separator is in contact with the patient tissue and rotated in the first direction, wherein the first direction is opposite a second direction; and

a blunt edge disposed along a second portion of the rim, wherein the second portion of the rim is distal to the separating mechanism, wherein when the cylindrical separator is in contact with the patient tissue and rotated in the second direction, the blunt edge contacts the patient tissue and the leading edge does not separate the patient tissue;

wherein the flexible sheath and the cylindrical separator are configured for placement over the pacing lead, and wherein the flexible sheath is configured such that a proximal rotation of the flexible sheath results in a distal rotation of the flexible sheath having about a 1;

1 torque response.

2. The system according to claim 1, wherein the separating mechanism comprises a member selected from the group consisting of a cutting blade, a stripping blade, and a dilating blade.

3. The system according to claim 1, wherein the separating mechanism is configured to not sever tissue when the cylindrical separator is pressed lightly against the patient tissue.

4. The system according to claim 1, wherein the separating mechanism comprises a sharp surface on at least a portion of an outer diameter of the recess.

5. The system according to claim 1, wherein the recess comprises a beveled surface.

6. The system according to claim 1, wherein the separating mechanism comprises a sharp surface on at least a portion of an inner diameter of the recess.

7. The system according to claim 1, wherein the recess comprises a notch type shape.

8. The system of claim 1, wherein the flexible sheath comprises a braid.

12. The system according to claim 1, wherein an acute angle between the plane and the central longitudinal axis is within a range from about 30 degrees to about 85 degrees.

9. A system for separating a pacing lead from a patient tissue, comprising:

a flexible sheath having a distal end;

a handle coupled with the flexible sheath at a position proximal to the distal end of the flexible sheath; and

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 cylindrical separator is coupled to the distal end of the flexible sheath, and the distal end of the cylindrical separator comprises;

a leading edge that defines a plane, wherein the leading edge faces at least partially in a first direction to separate the patient tissue when the cylindrical separator is in contact with the patient tissue and rotated in the first direction, wherein the first direction is opposite a second direction;

a blunt edge, wherein when the cylindrical separator is in contact with the patient tissue and rotated in the second direction, the blunt edge contacts the patient tissue and the leading edge does not separate the patient tissue; and

a recess disposed in a first portion of the leading edge, wherein the recess is disposed proximal to the blunt edge;

wherein the flexible sheath and the cylindrical separator are configured for placement over the pacing lead, and wherein the flexible sheath is configured such that a proximal rotation of the flexible sheath results in a distal rotation of the flexible sheath having about a 1;

1 torque response.

10. The system according to claim 9, wherein the plane is substantially perpendicular to the central longitudinal axis of the cylindrical separator.

11. The system according to claim 9, wherein the plane is not substantially perpendicular to the central longitudinal axis of the cylindrical separator.

13. The system according to claim 9, wherein the recess comprises a beveled surface.

14. The system according to claim 9, wherein the recess comprises a sharp surface on at least one of an inner and outer diameter.

15. The system according to claim 9, wherein an acute angle between the plane and the central longitudinal axis is within a range from about 30 degrees to about 85 degrees.

16. A system for separating a pacing lead from a patient tissue, comprising:

a sheath having a distal end;

a handle coupled to the sheath at a position proximal to the distal end of the sheath;

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

a separating mechanism disposed in at least one recess of a distal leading edge that defines a plane, wherein an acute angle between the plane and the central longitudinal axis is within a range from about 30 degrees to about 85 degrees, wherein the distal leading edge faces at least partially in a first direction to separate the patient tissue when the cylindrical separator is in contact with the patient tissue and rotated in the first direction, wherein the first direction is opposite a second direction; and

a blunt edge, wherein the blunt edge is disposed distal to the separating mechanism, wherein when the cylindrical separator is in contact with the patient tissue and rotated in the second direction, the blunt edge contacts the patient tissue and the leading edge does not separate the patient tissue, and wherein the sheath and the cylindrical separator are configured for placement over the pacing lead.

17. The system according to claim 16, wherein a portion of an inside diameter of the recess is sharp.

18. The system according to claim 16, wherein the at least one recess comprises a scoop type shape.

19. The system according to claim 16, wherein the at least one recess comprises four recesses equally spaced around the leading edge.

20. The system according to claim 16, wherein the at least one recess comprises a notch type shape.

21. The system according to claim 16, wherein the acute angle is in a range from about 60 degrees to about 80 degrees.

22. The system according to claim 16, wherein the at least one recess comprises a blade disposed along an outer diameter of the at least one recess.