TISSUE SLITTING METHODS AND SYSTEMS

• US 20140081304A1
• Filed: 03/14/2013
• Published: 03/20/2014
• Est. Priority Date: 09/14/2012
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Bowe, Wade A., Burton, George Woodrow, Dalby, Paul Joseph, Fiser, Richard Lofton, Sotak, Ryan Michael, James, Matthew Allan
• Granted Patent: US 9,413,896 B2
• Time in Patent Office: Days
• US Class Current: 606/170
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/50 Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body locating otherwise A61B5/06; locating by radiation A61B6/00; removing calculi A61B17/22; from the eyes A61F9/00709
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• 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
• CPC Class Codes: F04C 2270/041 Controlled or regulated
• CPC Class Codes: G10L 21/00 Speech or voice signal processing techniques to produce another audible or non-audible signal, e.g. visual or tactile, in order to modify its quality or its intelligibility G10L19/00 takes precedence
• CPC Class Codes: H04L 65/403 Arrangements for multi-party communication, e.g. for conferences data switching systems for conference H04L12/18; arrangements for connecting several subscribers to a common circuit, i.e. affording conference facilities H04M3/56; television conferencing systems H04N7/15
• CPC Class Codes: H04M 3/568 audio processing specific to telephonic conferencing, e.g. spatial distribution, mixing of participants echo suppression in two-way loud-speaking telephone systems H04M9/02; sound field processing per se H04S7/30

Abstract

Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting device is configured to engage patient formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting device is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting device causes the tissue to separate along an axial direction of the length of the formed tissue and releases at least some of the force containing the object. The methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Claims

1. A tissue slitting apparatus comprising:

a shaft, wherein the shaft is flexible, the shaft having a proximal and a distal end, and wherein the shaft includes an inner lumen running from the proximal to the distal end to receive at least one of an implanted object and mechanical traction device; and

a tissue abrading device disposed adjacent to the distal end of the shaft, wherein the tissue abrading device is configured to wear a separation in a tissue growth along a side and a length of the tissue growth, and wherein the tissue slitting apparatus separates a first, but not a second, portion of the tissue growth around a circumference of the implanted object.

2. The tissue slitting apparatus of claim 1, wherein the tissue abrading device further comprises:

a leading edge disposed at a distal portion of the tissue abrading device; and

an abrading tip, wherein the abrading tip is disposed adjacent to the leading edge, and wherein the abrading tip includes at least one abrasive surface.

3. The tissue slitting apparatus of claim 2, wherein the abrading tip is at least partially covered, the partial covering disposed about the abrading tip to expose only a portion of the abrasive surface to the tissue growth.

4. The tissue slitting apparatus of claim 2, wherein the abrasive surface is manufactured from a material with at least one of a rough surface, knurl, machined surface, formed surface, and diamond deposition surface.

5. The tissue slitting apparatus of claim 4, wherein the material is made of metal.

6. The tissue slitting apparatus of claim 4, wherein the material is made of plastic.

7. The tissue slitting apparatus of claim 2, wherein the abrading tip is configured to move relative to the leading edge from a first position to a second position as the tissue abrading device contacts the tissue growth.

8. The tissue slitting apparatus of claim 1, wherein the tissue abrading device further comprises:

an actuator, wherein the tissue abrading tip is operatively coupled with the actuator, and wherein the actuator, when actuated, is configured to move the tissue abrading tip relative to the tissue growth.

9. The tissue slitting apparatus of claim 8, wherein the at least one abrasive surface of the tissue abrading tip is exposed to the tissue growth by actuating the actuator.

10. The tissue slitting apparatus of claim 8, wherein the at least one abrasive surface is rotated by actuating the actuator.

11. The tissue slitting apparatus of claim 8, wherein the at least one abrasive surface is moved in a reciprocal motion relative to the tissue growth by actuating the actuator.

12. The tissue slitting apparatus of claim 2, wherein the abrading tip further comprises:

an actuator; and

at least one rotating member, the at least one rotating member having one or more abrasive surfaces, wherein the at least one rotating member is operatively coupled with the actuator, and wherein the at least one rotating member is configured to rotate via an actuation force provided by the actuator.

13. The tissue slitting apparatus of claim 12, wherein the actuator is powered by an electric motor.

14. The tissue slitting apparatus of claim 12, wherein the actuator is powered by a pneumatic motor.

15. The tissue slitting apparatus of claim 12, wherein the actuator is powered by a hydraulic motor.

16. The tissue slitting apparatus of claim 12, wherein the abrading tip comprises three or more rotating members operatively connected to each other, and wherein each of the three or more rotating members are actuated together via the actuator.

17. The tissue slitting apparatus of claim 12, wherein the abrading tip is at least partially covered by a shield, wherein the shield is configured to expose the one or more abrasive surfaces to the tissue growth.

18. A method, the method comprising:

separating only a portion of a tissue growth at least substantially surrounding an implanted object in a patient; and

thereafter removing the implanted object from the tissue growth.

19. The method of claim 18, wherein the separating and thereafter removing steps comprise the sub-steps:

attaching a mechanical traction device to the implanted object;

inserting the mechanical fraction device into a tissue slitting apparatus, the tissue slitting apparatus further comprising;

a flexible shaft, wherein the flexible shaft has a proximal and a distal end;

an internal lumen, wherein the internal lumen is configured to allow at least one of an implanted object and mechanical traction device to pass therethrough; and

a tissue abrading device operatively connected to the distal end of the flexible shaft, wherein the tissue abrading device is configured to wear a separation in the tissue growth along a side and a length of the tissue growth, and wherein the tissue slitting apparatus separates a first, but not a second, portion of the tissue growth around a circumference of the implanted object;

applying a mechanical traction force to the mechanical traction device;

indexing the tissue slitting apparatus to an engagement area of the tissue growth in contact with the implanted object;

moving the tissue abrading device into the tissue growth; and

actuating the tissue abrading device, such that the tissue growth is separated from the implanted object at least at the engagement area with the tissue abrading device.

20. The method of claim 19, wherein the tissue abrading device separates a first, but not a second, portion of the tissue growth around a circumference of the implanted object and wherein prior to indexing the tissue slitting apparatus to the engagement area, the method further comprises:

orienting the tissue abrading device to separate tissue along a free length of the tissue growth where the tissue growth is free from attachment to a portion of vasculature of the patient.

21. The method of claim 20, wherein orienting the tissue abrading device further comprises:

aligning the tissue abrading device along an area of the free length of the tissue growth wherein a thickness of the first section of the tissue growth surrounding the implanted object is less than a thickness of a second section of the tissue growth surrounding the implanted object, and wherein the second length of the tissue growth is attached to the vasculature of the patient.

22. The method of claim 19, further comprising:

determining whether the tissue growth is completely separated along a length of the tissue growth surrounding the implanted object; and

moving the tissue abrading device further into the tissue growth to separate any tissue growth determined to remain along the length of the tissue growth surrounding the implanted object.

23. The method of claim 19, further comprising:

actuating the tissue abrading device once the tissue slitting apparatus is indexed to the engagement area of the tissue growth in contact with the implanted object, wherein the actuation causes the tissue abrading device to one or more of deploy and separate the tissue growth.

24. The method of claim 19, wherein the tissue abrading device further comprises:

a leading edge disposed at a distal portion of the tissue abrading device; and

an abrading tip, wherein the abrading tip is disposed adjacent to the leading edge, and wherein the abrading tip includes at least one abrasive surface.

25. The method of claim 24, wherein the tissue abrading tip further comprises:

an actuator; and

at least one rotating member, the at least one rotating member having one or more abrasive surfaces, wherein the at least one rotating member is operatively coupled with the actuator, and wherein the at least one rotating member is configured to rotate via an actuation force provided by the actuator.

26. The method of claim 25, wherein the abrading tip is at least partially covered by a shield configured to expose the one or more abrasive surfaces to the tissue growth.

27. The method of claim 26, further comprising aligning an exposed portion of the one or more abrasive surfaces to the tissue growth while orienting the shield to an area of the vasculature other than the tissue growth.

28. The method of claim 18, wherein the tissue growth portion is subjected to a slitting action about a partial periphery of an internal diameter of the tissue growth adjacent to and at least substantially surrounding the implanted object at any point along the implanted object.

29. A system to remove tissue from a vascular lumen, the system comprising:

a lead locking device for locking onto a lead within the vascular lumen;

a flexible shaft comprising

a proximal end;

a distal end comprising at least one abrasive surface capable of wearing through tissue; and

an internal lumen configured to allow at least one lead to pass therethrough, wherein the lead locking device holds the lead while the at least one abrasive surface wears through a section of tissue surrounding at least a portion of the lead.

30. The system according to claim 29, wherein the flexible shaft further comprises:

a leading edge disposed at the distal end; and

an abrading tip, wherein the abrading tip is disposed adjacent to the leading edge, and wherein the abrading tip includes the at least one abrasive surface.

31. The system according to claim 29, further comprising:

an actuator; and

at least one rotating member disposed adjacent to the distal end of the flexible shaft, the at least one rotating member operatively connected to the one or more abrasive surfaces, wherein the at least one rotating member is operatively coupled with the actuator, and wherein the at least one rotating member is configured to rotate via an actuation force provided by the actuator.

32. The system according to claim 29, wherein the lead locking device is configured to lock onto an internal structure of the lead.

33. The system according to claim 29, wherein the lead locking device is configured to lock onto an external structure of the lead.