TISSUE SLITTING METHODS AND SYSTEMS

• US 20140081252A1
• 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, Schneider, Blaine Andrew
• Granted Patent: US 10,531,891 B2
• Time in Patent Office: Days
• US Class Current: 606/10
• 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 radiative energy emitting device disposed adjacent to the distal end of the shaft, wherein the radiative energy emitting device is configured to ablate 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 radiative energy emitting device is configured to emit energy in the form of one or more of light, thermal energy, and electromagnetic energy.

3. The tissue slitting apparatus of claim 1, wherein the radiative energy emitting device further comprises:

a laser light source configured to generate light energy; and

a light guide, wherein the light guide is optically coupled to the laser light source, and configured to direct laser light toward the tissue growth.

4. The tissue slitting apparatus of claim 3, wherein the laser light source is configured to output one or more wavelengths of laser light.

5. The tissue slitting apparatus of claim 3, wherein the laser light source is an XeCl Excimer laser and the light energy has a wavelength of about 308 nm.

6. The tissue slitting apparatus of claim 3, wherein the light guide includes one or more optical fibers arranged within the shaft.

7. The tissue slitting apparatus of claim 3, further comprising:

a second laser light source configured to generate light energy, wherein the light energy generated by the second laser light source has a wavelength other than 308 nm.

8. The tissue slitting apparatus of claim 3, further comprising:

at least one optical component disposed between the light guide and the laser light source, wherein the at least one optical component is configured to alter a characteristic associated with the light energy.

9. The tissue slitting apparatus of claim 8, wherein the at least one optical component is one or more of a filter, lens, prism, coating, film, and deposited layer of optically transmissive material.

10. The tissue slitting apparatus of claim 3, wherein the radiative energy emitting device is at least partially disposed within the distal end of the shaft, and wherein the tissue growth is subjected to a radiative energy slitting action only 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.

11. The tissue slitting apparatus of claim 3, wherein the radiative energy emitting device is configured to move relative to the distal end from a first position to a second position as the tissue slitting apparatus contacts the tissue growth.

12. The tissue slitting apparatus of claim 11, wherein the radiative energy emitting device moves against a spring, and wherein the spring is configured to exert a force against the radiative energy emitting device and maintain the first position of the radiative energy emitting device when the tissue slitting apparatus moves past the tissue growth.

13. The tissue slitting apparatus of claim 3, wherein the light guide of the radiative energy emitting device is disposed at an angle to an axis running along the inner lumen of the shaft.

14. The tissue slitting apparatus of claim 3, wherein the light guide of the radiative energy emitting device is disposed substantially parallel to an axis running along the inner lumen of the shaft and proximally tangential to a circumference of the inner lumen.

15. The tissue slitting apparatus of claim 13, wherein the light guide is an array of optical fibers.

16. 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.

17. The method of claim 16, 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 radiative energy emitting device operatively connected with the distal end of the flexible shaft;

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 radiative energy emitting device adjacent to the tissue growth; and

activating the radiative energy emitting device, such that a section of the tissue growth is ablated and separated from the implanted object at least at the engagement area with the radiative energy emitting device.

18. The method of claim 17, wherein the radiative energy emitting 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 radiative energy emitting 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.

19. The method of claim 18, wherein orienting the radiative energy emitting device further comprises:

aligning the radiative energy emitting 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.

20. The method of claim 17, further comprising:

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

moving the radiative energy emitting device further into the tissue growth to ablate and separate any tissue growth determined to remain along the length of the tissue growth surrounding the implanted object.

21. The method of claim 17, wherein prior to activating the radiative energy emitting device, the method further comprises:

determining a type of tissue in the vasculature; and

switching to a different radiative energy output by the radiative energy emitting device, in response to determining the type of tissue in the vasculature.

22. The method of claim 16, wherein the tissue growth 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.

23. 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 a radiative energy emitting device capable of ablating 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 radiative energy emitting device ablates tissue surrounding at least a portion of the lead.

24. The system according to claim 23, wherein the radiative energy emitting device further comprises:

a laser light source configured to generate light energy; and

a light guide, wherein the light guide is optically coupled to the laser light source, and configured to direct laser light toward the tissue growth.

25. The system according to claim 24, wherein the laser light source is configured to output one or more wavelengths of laser light.

26. The system according to claim 23, wherein the lead locking device is configured to lock onto an internal structure of the lead.

27. The system according to claim 23, wherein the lead locking device is configured to lock onto an external structure of the lead.