Tissue slitting methods and systems

• US 9,763,692 B2
• Filed: 03/14/2013
• Issued: 09/19/2017
• 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, Sotak, Ryan Michael
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US13/828,441
• Publication Number:
  US 20140081306A1
• Time in Patent Office: 1,650 Days
• Field of Search: 606129, 606159, 606170, 606190, 30 904, 604272
• 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 method for separating an implanted object in a patient from a tissue growth surrounding at least a portion of a circumference of the implanted object, the method comprising:

providing a tissue slitting apparatus comprising a flexible shaft, wherein the flexible shaft has a proximal end, a distal end including a wedge shape that defines a knife-edge at a distal leading edge of the most distal portion of the tissue slitting apparatus, wherein the wedge shape is stationary with respect to the flexible shaft and tapers outwardly proceeding proximally from the knife-edge, and an internal lumen extending between the proximal end and the distal end, the knife-edge including at least one point coincident with the internal lumen;

slitting the tissue growth along its length at only a first radial position relative to the implanted object with the knife-edge of the flexible shaft and simultaneously parting the tissue along the wedge shape of the flexible shaft; and

thereafter removing the implanted object from the tissue growth.

2. The method of claim 1, wherein the distal end of the flexible shaft comprises a fluid conveying device, and wherein the slitting and thereafter removing steps comprise the sub-steps:

attaching a mechanical traction device to the implanted object;

inserting the mechanical traction device into the tissue slitting apparatus;

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 fluid conveying device adjacent to the tissue growth; and

activating the fluid conveying device, such that a section of the tissue growth is ablated and separated from the implanted object at least at the engagement area with pressurized fluid directed via the fluid conveying device.

3. The method of claim 2, wherein the fluid conveying device slits a first, but not a second, portion of the tissue growth around the circumference of the implanted object and wherein prior to indexing the tissue slitting apparatus to the engagement area, the method further comprises:

orienting the fluid conveying device to slit tissue along a free length of the tissue growth aligned with the first radial position relative to the implanted object and where the tissue growth is free from attachment to a portion of vasculature of the patient.

4. The method of claim 3, wherein orienting the fluid conveying device further comprises:

aligning the fluid conveying device along an area of the free length of the tissue growth wherein a thickness of a 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 section of the tissue growth is attached to the vasculature of the patient.

5. The method of claim 2, further comprising:

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

moving the fluid conveying 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.

6. The method of claim 1, wherein the slitting step comprises slitting 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.

7. The method of claim 1, further comprising:

attaching a mechanical traction device to the implanted object;

inserting the mechanical traction device into the internal lumen of the tissue slitting apparatus;

applying a mechanical traction force to the mechanical traction device; and

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

thereafter performing the slitting and removing steps.

8. The method of claim 7, wherein the knife-edge slits a first, but not a second, portion of the tissue growth around the circumference of the implanted object and wherein prior to indexing the tissue slitting apparatus to the engagement area, the method further comprises:

orienting the knife-edge to slit tissue along a free length of the tissue growth aligned with the first radial position relative to the implanted object and where the tissue growth is free from attachment to a portion of vasculature of the patient.

9. The method of claim 8, wherein orienting the knife-edge further comprises:

aligning the knife-edge along an area of the free length of the tissue growth wherein a thickness of a 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 section of the tissue growth is attached to the vasculature of the patient.