U.S. patent application number 16/703566 was filed with the patent office on 2020-04-09 for tissue slitting methods and systems.
The applicant listed for this patent is THE SPECTRANETICS CORPORATION. Invention is credited to Wade A. BOWE, George Woodrow BURTON, Paul Joseph DALBY, Kenneth P. GRACE, Blaine Andrew SCHNEIDER, Ryan Michael SOTAK.
Application Number | 20200107854 16/703566 |
Document ID | / |
Family ID | 50275252 |
Filed Date | 2020-04-09 |
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United States Patent
Application |
20200107854 |
Kind Code |
A1 |
BOWE; Wade A. ; et
al. |
April 9, 2020 |
TISSUE SLITTING METHODS AND SYSTEMS
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.
Inventors: |
BOWE; Wade A.; (COLORADO
SPRINGS, CO) ; BURTON; George Woodrow; (COLORADO
SPRINGS, CO) ; DALBY; Paul Joseph; (COLORADO SPRINGS,
CO) ; GRACE; Kenneth P.; (WOODLAND PARK, CO) ;
SOTAK; Ryan Michael; (COLORADO SPRINGS, CO) ;
SCHNEIDER; Blaine Andrew; (COLORADO SPRINGS, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
THE SPECTRANETICS CORPORATION |
COLORADO SPRINGS |
|
CO |
|
|
Family ID: |
50275252 |
Appl. No.: |
16/703566 |
Filed: |
December 4, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13828383 |
Mar 14, 2013 |
10531891 |
|
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16703566 |
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61701521 |
Sep 14, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/320044
20130101; A61B 90/02 20160201; A61B 17/320725 20130101; F04C
2270/041 20130101; A61N 1/056 20130101; A61B 17/3203 20130101; A61N
1/057 20130101; G10L 21/00 20130101; A61N 2001/0578 20130101; A61B
17/50 20130101; A61B 2017/320004 20130101; A61N 1/05 20130101; H04L
65/403 20130101; A61B 18/245 20130101; H04M 3/568 20130101; A61B
17/32037 20130101; A61B 17/3207 20130101; A61B 17/32075 20130101;
A61B 17/3211 20130101 |
International
Class: |
A61B 17/3207 20060101
A61B017/3207; A61N 1/05 20060101 A61N001/05; A61B 90/00 20060101
A61B090/00; A61B 17/3203 20060101 A61B017/3203; A61B 17/3211
20060101 A61B017/3211; A61B 17/50 20060101 A61B017/50; A61B 18/24
20060101 A61B018/24; H04L 29/06 20060101 H04L029/06; H04M 3/56
20060101 H04M003/56; G10L 21/00 20060101 G10L021/00 |
Claims
1. A device for slitting tissue, comprising: a shaft configured to
be coupled to a laser light source, wherein the shaft is flexible,
the shaft comprising: a proximal end; a distal end comprising a top
portion and a bottom portion, wherein the distal end is tapered
from the top portion to the bottom portion, wherein the bottom
portion is distal to the top portion, wherein the bottom portion is
biased, thereby creating a left-facing biased bottom portion and a
right-facing biased bottom portion; an inner lumen running from the
distal end and configured to receive at least one implanted object,
wherein the inner lumen is parallel to a longitudinal axis running
along the inner lumen of the shaft; and a plurality of optical
fibers carried by the shaft and exposed at the bottom portion of
the distal end of the shaft, wherein at least one of the plurality
of optical fibers is exposed from the left-facing biased bottom
portion and another of the plurality of optical fibers is exposed
from the right-facing biased bottom portion, and wherein the
plurality of optical fibers transmit light energy at an angle
relative to the longitudinal axis to ablate tissue at least
partially surrounding the implanted object while the implanted
object is disposed in the first inner lumen.
2. The device of claim 1, wherein the left-facing biased bottom
portion and a right-facing biased bottom portion form a wedge.
3. The device of claim 2, wherein the plurality of optical fibers
are only exposed at the bottom portion of the distal end of the
shaft.
4. The device of claim 3, wherein at least two of the plurality of
optical fibers are exposed from the left-facing biased bottom
portion and another two of the plurality of optical fibers are
exposed from the right-facing biased bottom portion.
5. The device of claim 2, wherein the wedge comprises a cutting
edge.
6. The device of claim 5, wherein the plurality of optical fibers
are only exposed at the bottom portion of the distal end of the
shaft.
7. The device of claim 1, wherein the plurality of optical fibers
are only exposed at the bottom portion of the distal end of the
shaft.
8. A system for slitting tissue, comprising: a laser light source
configured to generate light energy; a shaft coupled to the laser
light source, wherein the shaft is flexible, the shaft comprising:
a proximal end; a distal end comprising a top portion and a bottom
portion, wherein the distal end is tapered from the top portion to
the bottom portion, wherein the bottom portion is distal to the top
portion, wherein the bottom portion is biased, thereby creating a
left-facing biased bottom portion and a right-facing biased bottom
portion; an inner lumen running from the distal end and configured
to receive at least one implanted object, wherein the inner lumen
is parallel to a longitudinal axis running along the inner lumen of
the shaft; and a plurality of optical fibers carried by the shaft
and exposed at the bottom portion of the distal end of the shaft,
wherein at least one of the plurality of optical fibers is exposed
from the left-facing biased bottom portion and another of the
plurality of optical fibers is exposed from the right-facing biased
bottom portion, and wherein the plurality of optical fibers
transmit light energy at an angle relative to the longitudinal axis
to ablate tissue at least partially surrounding the implanted
object while the implanted object is disposed in the first inner
lumen.
9. The system of claim 8, wherein the laser light source is
configured to output one or more wavelengths of light energy.
10. The system of claim 9, wherein the light energy is 308
nanometers.
11. The system of claim 8, wherein the laser light source is an
XeCl excimer laser and the wavelength of light energy is 308
nanometers.
12. The system of claim 8, wherein the left-facing biased bottom
portion and a right-facing biased bottom portion form a wedge.
13. The system of claim 12, wherein the plurality of optical fibers
are only exposed at the bottom portion of the distal end of the
shaft.
14. The system of claim 13, wherein at least two of the plurality
of optical fibers are exposed from the left-facing biased bottom
portion and another two of the plurality of optical fibers are
exposed from the right-facing biased bottom portion.
15. The system of claim 12, wherein the wedge comprises a cutting
edge.
16. The system of claim 15, wherein the plurality of optical fibers
are only exposed at the bottom portion of the distal end of the
shaft.
17. The system of claim 8, wherein the plurality of optical fibers
are only exposed at the bottom portion of the distal end of the
shaft.
18. A device for slitting tissue, comprising: a shaft configured to
be coupled to a laser light source, wherein the shaft is flexible,
the shaft comprising: a proximal end; a distal end comprising a top
portion and a bottom portion, wherein the distal end is tapered
from the top portion to the bottom portion, wherein the bottom
portion is distal to the top portion; an inner lumen running from
the distal end and configured to receive at least one implanted
object, wherein the inner lumen is parallel to a longitudinal axis
running along the inner lumen of the shaft; and a plurality of
optical fibers carried by the shaft and exposed at only the bottom
portion of the distal end of the shaft, and wherein the plurality
of optical fibers transmit light energy at an angle relative to the
longitudinal axis to ablate tissue at least partially surrounding
the implanted object while the implanted object is disposed in the
first inner lumen.
19. The system of claim 18, wherein the laser light source is
configured to output one or more wavelengths of light energy.
20. The system of claim 19, wherein the light energy includes 308
nanometers.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation of U.S.
application Ser. No. 13/828,383, filed Mar. 14, 2013, entitled
TISSUE SLITTING METHODS AND SYSTEMS, which claims the benefit of
and priority to, under 35 U.S.C. .sctn. 119(e), U.S. Provisional
Application Ser. No. 61/701,521, filed Sep. 14, 2012, entitled
TISSUE SEPARATING METHODS AND SYSTEMS, which are hereby
incorporated by reference in their entireties for all purposes.
[0002] This application is also related to U.S. patent application
Ser. No. 13/828,231, filed on Mar. 14, 2013, entitled, "Tissue
Slitting Methods and Systems"; Ser. No. 13/828,310, filed on Mar.
14, 2013, entitled, "Tissue Slitting Methods and Systems"; Ser. No.
13/828,441, filed on Mar. 14, 2013, entitled, "Tissue Slitting
Methods and Systems"; Ser. No. 13/828,638, filed on Mar. 14, 2013,
entitled, "Lead Removal Sleeve"; and Ser. No. 13/828,536, filed on
Mar. 14, 2013, entitled, "Expandable Lead Jacket". The entire
disclosures of the applications listed above are hereby
incorporated herein by reference, in their entirety, for all that
they teach and for all purposes.
FIELD OF THE DISCLOSURE
[0003] The present disclosure relates generally to devices, methods
and systems for separating tissue in a patient, and more
specifically, to techniques for separating tissue attached to leads
in a patient.
BACKGROUND
[0004] Cardiac pacing systems typically include a pacemaker and one
or more leads, which are placed inside the body of a patient. The
pacemaker includes a power source and circuitry configured to send
timed electrical pulses to the lead. The lead carries the
electrical pulse to the heart to initiate a heartbeat and transmits
information about the heart's electrical activity to the pacemaker.
The lead can include a fixation mechanism that holds the lead to
the cardiac tissue. In some cases, a lead is inserted through a
vein or artery (collectively vasculature) and guided to the heart
where it is attached. In other instances, a lead is attached to the
outside of the heart. During its time in the body, tissue can
attach to the lead in the form of lesions, adhesions or scar
tissue, or tissue can encase a lead. In addition, the lead and/or
tissue can become attached to the vasculature wall. At times, leads
may be removed from patients for numerous reasons, including but
not limited to, infections, lead age, and lead malfunction.
Accordingly, removal or extraction of the lead may present
associated complications.
[0005] Current lead extraction techniques include mechanical
traction, mechanical devices, and laser devices. Mechanical
traction can be accomplished by inserting a locking stylet into the
hollow portion of the lead and then pulling the lead to remove it.
An example of such a lead locking device is described and
illustrated in U.S. Pat. No. 6,167,315 to Coe et al., which is
hereby incorporated herein by reference in its entirety for all
that it teaches and for all purposes. In some cases, dilating
telescopic sheaths may also be used to strip away the scar tissue
adhering the lead to the body. Examples of a such devices and
methods used to extract leads is described and illustrated in U.S.
Patent Publication No. 2008/0154293 to Taylor, which is hereby
incorporated herein by reference in its entirety for all that it
teaches and for all purposes.
[0006] Dilation techniques typically involve pushing tissue away
from the lead when the sheath is pushed longitudinally along the
lead. However, this pushing technique may be difficult to
implement, particularly when the lead has a tortuous path or
curvature because the requisite longitudinal forces to extract the
tissue from the lead in under these circumstances increase. The
longitudinal forces also may require heavy counter forces on the
lead, which may result in lead breakage.
[0007] Some mechanical sheaths have proposed trigger mechanisms for
extending a blade from a sheath. At least some of these devices,
however, involve complicated activation mechanisms and may not be
well suited for negotiating the tortuous paths that exist in
certain vascular or physiological environments.
[0008] Laser devices typically employ laser energy to cut the scar
tissue away from the lead thus allowing for removal. Examples of
such laser devices and systems are described and illustrated in
U.S. Pat. Nos. 5,383,199 and 5,824,026 and 5,916,210 and 6,228,076
and 6,290,668 all of which are hereby incorporated herein by
reference in their entirety for all that they teach and for all
purposes.
[0009] Further complicating lead removal is the fact that in some
cases, the leads may be located in, and/or attached to, the body of
a patient in a structurally-weak portion of the vasculature. For
instance, typical leads in a human may pass through the innominate
vein, past the superior vena cava ("SVC"), and into the right
atrium of the heart. A majority of tissue growth can occur along
the SVC and other locations along the innominate vein where the
leads make contact with the vein walls. However, tissue growth can
also occur at locations within a patient where the leads make
contact with arterials or other areas of the vasculature. Certain
veins and arteries, and certain areas of vein and arterial walls,
can be thin which can make lead removal a complicated and delicate
process.
SUMMARY
[0010] A traditional approach to removing tissue from implanted
leads is based on the presumption that the tissue growths are
adhered directly to the surfaces of the implanted leads. As such,
methods and systems have been designed to dislocate the connection
between the tissue attached to the implanted device and the body of
a patient. Although some tissue may remain on the lead, current
methods focus on removing most of the tissue surrounding a
circumference of the lead. In other words, while tissue may remain
attached around the lead, current systems essentially core around
this tissue surrounding the circumference of a lead to free the
lead along with a section of the cored tissue to create slack for
removing the lead from a patient.
[0011] Surprisingly and unexpectedly, it has been discovered that
tissue growth may not adhere directly to the implanted lead but
actually form a substantially cylindrical "tube" around the
implanted substantially cylindrical lead at a given contact area.
Contrary to conventional wisdom, the tissue growth typically does
not physically adhere to the lead. For example, this tissue growth,
once formed completely around a lead, forms a tubular-shaped member
that essentially holds the lead and resists lead removal. The
tubular-shaped section of formed tissue around an implanted device
may impart a combination of connection forces/modes that prevent
the removal of the device from a patient. For example, the
tubular-shaped section of formed tissue, or tissue growth, may
constrict, capture, and/or surround implanted leads. In some cases,
the tissue growth may constrict a lead, especially if a force is
applied to one end of the lead during a removal operation. In other
cases, the tissue growth may capture the lead and prevent removal,
by, among other things, being attached to the patient and the lead
simultaneously. Additionally, or alternatively, the tissue growth,
during attempted lead removal, may at least partially adhere to the
lead in one or more sections while completely forming around the
lead.
[0012] Based upon the surprising and unexpected discovery that
tissue growth may not be directly adhered to the implanted lead,
alternative devices and methods may be used to extract an object
from such tissue. In other words, methods and devices are disclosed
herein, that are capable of exploiting the growth nature of the
tissue around a lead to efficiently extract the lead from tissue
that acts to hold the lead with some type of force. The tissue
growth may form around the lead such that the lead is contained
from free movement within a patient. For instance, the tissue
growth may impart a clamping, or constrictive, force around the
circumference of the lead that can prevent movement of the lead
within this constrictive tissue growth. Due to the taught and
constrictive nature of the tissue around the lead, the lead may be
able to be removed without mechanically removing or laser ablating
the entire tissue region surrounding the lead in a 360 degree, or
circumferential, fashion. Rather, initiating a cut and/or slit of
the tissue along a longitudinal axis of the lead may allow a
surgeon to easily separate the lead from the tissue via the slit.
For example, once the tissue is initially slit, a surgeon may be
able to extract the lead from the tissue, by pulling the lead with
the use of a lead locking, or similar, device. This lead extraction
may be made possible by the initial slit reducing the restrictive
forces caused by tissue growth in a given area. Lead extraction may
also be affected by moving the lead against the initial slit
created to tear through the tissue growth.
[0013] The tissue growth may need to be slit or cut along an entire
length of tissue growth such that the tissue growth is no longer
capable of imparting clamping, or constrictive, forces around the
lead. Once the tissue growth is slit along its length, removal of
the lead from the section of tissue growth can be achieved using
various lead removal techniques, including but not limited to,
traction/counter-traction applied to the lead and growth, lead
locking devices, snares, sheath insertion, moving the lead against
the slit portion of the tissue, and the like.
[0014] Accordingly, there is a need for a device, method and/or
system such as a device that includes a tissue slitting or cutting
edge that facilitates slitting a length of formed tissue
surrounding a lead, and optionally a method and system capable of
removing the lead from the formed tissue that captures at least a
portion of an implanted lead.
[0015] In an embodiment, a tissue slitting apparatus is provided
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.
[0016] In another embodiment, a method is provided 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. In one
embodiment, the separating and thereafter removing steps may
comprise the sub-steps: attaching a mechanical traction device to
the implanted object; inserting the mechanical traction 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.
[0017] In yet another embodiment, a system to remove tissue from a
vascular lumen is provided, 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.
[0018] The method can include the steps of cutting only a portion
of a tissue growth at least substantially surrounding an implanted
object in a patient and thereafter removing the implanted object.
In embodiments disclosed herein, the tissue growth may be subjected
to a slitting action about a partial (i.e., not complete) periphery
of an internal diameter of the tissue growth. In some embodiments,
the tissue growth portion cut can be no more than about 50% of a
perimeter of the tissue growth adjacent to and surrounding,
substantially or completely, the implanted object at any point
along an encased length of the implanted object.
[0019] The tissue slitting edge may include sharpened area, point,
or blade, in a static fixed and/or dynamically deployable
configuration. Additionally, or alternatively, the tissue slitting
edge may utilize grinding mechanisms to cause a slit in the formed
tissue. Additionally, or alternatively, the tissue slitting edge
may utilize emitted energy, such as light, thermal energy,
electromagnetic energy, and/or high-pressure fluid emission to
cause a slit in the formed tissue. The tissue slitting edge can be
an energy device, such as a power sheath, which typically applies a
form of energy at the sheath tip to cut the scar tissue away from
the lead thus allowing for removal. As the sheath is pushed over
the lead and comes to an area of attachment, the operator can turn
on the sheath's energy source to heat or vaporize scar tissue,
forming the desired slit. One of these specialized sheaths uses
electrocautery, similar to what is used to cut through tissue in
surgery. Another sheath has one or more tiny lasers at its tip or
edge. When activated, the lasers vaporize water molecules in scar
tissue within 1 mm, forming the desired slit or cut. Additionally,
or alternatively, dilating telescopic sheaths or inflatable
balloons having a longitudinally positioned tissue slitting edge
can be expanded, thereby deploying the tissue slitting edge to form
the desired slit.
[0020] Accordingly, slitting devices (e.g., in the form of
knife-edges, blades, planers, lasers and other electromagnetic
radiation emitters, high-pressure fluid, grinders, sanders, drills,
RF devices, ultrasonic devices, and the like) can be configured in
various combinations and methods by which formed tissue can be
removed from an implanted lead subjected to any combination of
connection modes via the formed tissue.
[0021] Removal of the formed tissue, or tissue growth, from a lead
may be affected by creating a slit, or cut, along a length of the
tissue growth. By slitting the formed tissue along an axial
portion, or length, of the tissue connected to the surgically
implanted device or surgical implant, it is anticipated that the
connection to the implanted lead will be severely weakened. In many
cases, the tissue slitting device may allow the implanted lead to
essentially peel away from the tissue previously surrounding the
implanted lead, thereby releasing it from containment. These and
other needs are addressed by the various aspects, embodiments,
and/or configurations of the present disclosure. Also, while the
disclosure is presented in terms of exemplary embodiments, it
should be appreciated that individual aspects of the disclosure can
be separately claimed.
[0022] The tissue slitting device includes a flexible shaft having
a proximal end, a distal end, and an internal lumen having an
internal diameter configured to allow a lead, lead locking device,
and/or other implanted device to pass through it. The device may
also include a tissue slitting tip operatively coupled with the
distal end of the flexible shaft. As can be appreciated, the
slitting of formed tissue can be performed by at least one of
cutting, drilling, slicing, stripping, chopping, sanding, grinding,
planing, abrasion, high-pressure fluid, laser ablation, and
combinations thereof. It is anticipated that the tissue slitting
device may be oriented within a patient via use of the flexible
shaft and monitor, or a catheter-based system. In some cases, the
tissue slitting device may be positioned toward the center of the
vasculature, and/or proximal to a non-traumatic leading edge, such
that any sharp, or working, edge is caused to contact tissue growth
and not contact the vasculature.
[0023] Among other things, the slitting section of the tissue
slitting device may be biased against a lead/object via spring
force. Additionally, or alternatively, the tissue slitting device
may include a flexible portion configured to allow the tissue
slitting device to move as directed within a patient.
[0024] The phrases "at least one", "one or more", and "and/or" are
open-ended expressions that are both conjunctive and disjunctive in
operation. For example, each of the expressions "at least one of A,
B and C", "at least one of A, B, or C", "one or more of A, B, and
C", "one or more of A, B, or C" and "A, B, and/or C" means A alone,
B alone, C alone, A and B together, A and C together, B and C
together, or A, B and C together. When each one of A, B, and C in
the above expressions refers to an element, such as X, Y, and Z, or
class of elements, such as X.sub.1-X.sub.n, Y.sub.1-Y.sub.m, and
Z.sub.1-Z.sub.o, the phrase is intended to refer to a single
element selected from X, Y, and Z, a combination of elements
selected from the same class (e.g., X.sub.1 and X.sub.2) as well as
a combination of elements selected from two or more classes (e.g.,
Y.sub.1 and Z.sub.o).
[0025] The term "a" or "an" entity refers to one or more of that
entity. As such, the terms "a" (or "an"), "one or more" and "at
least one" can be used interchangeably herein. It is also to be
noted that the terms "comprising", "including", and "having" can be
used interchangeably.
[0026] "Electromagnetic radiation" (EM radiation or EMR) is a form
of energy emitted and/or absorbed by charged particles, which
exhibits wave-like behavior as it travels through space. EMR has
both electric and magnetic field components, which stand in a fixed
ratio of intensity to each other, and which oscillate in phase
perpendicular to each other and perpendicular to the direction of
energy and wave propagation. EM radiation is commonly classified by
wavelength into radio, microwave, infrared, the visible spectrum
perceived as visible light, ultraviolet, X-rays, and gamma rays.
"Radiation" includes both EM radiation and static electric and
magnetic and near fields.
[0027] A "lead" is a conductive structure, typically an
electrically insulated coiled wire. The electrically conductive
material can be any conductive material, with metals and
intermetallic alloys common. The outer sheath of insulative
material is biocompatible and biostable (e.g., non-dissolving in
the body) and generally includes organic materials such as
polyurethane and polyimide. Lead types include, by way of
non-limiting example, epicardial and endocardial leads. Leads are
commonly implanted into a body percutaneously or surgically.
[0028] A "surgical implant" is a medical device manufactured to
replace a missing biological structure, support, stimulate, or
treat a damaged biological structure, or enhance, stimulate, or
treat an existing biological structure. Medical implants are
man-made devices, in contrast to a transplant, which is a
transplanted biomedical tissue. In some cases implants contain
electronics, including, without limitation, artificial pacemaker,
defibrillator, electrodes, and cochlear implants. Some implants are
bioactive, including, without limitation, subcutaneous drug
delivery devices in the form of implantable pills or drug-eluting
stents.
[0029] The term "means" as used herein shall be given its broadest
possible interpretation in accordance with 35 U.S.C., Section 112,
Paragraph 6. Accordingly, a claim incorporating the term "means"
shall cover all structures, materials, or acts set forth herein,
and all of the equivalents thereof. Further, the structures,
materials or acts and the equivalents thereof shall include all
those described in the summary of the invention, brief description
of the drawings, detailed description, abstract, and claims
themselves.
[0030] It should be understood that every maximum numerical
limitation given throughout this disclosure is deemed to include
each and every lower numerical limitation as an alternative, as if
such lower numerical limitations were expressly written herein.
Every minimum numerical limitation given throughout this disclosure
is deemed to include each and every higher numerical limitation as
an alternative, as if such higher numerical limitations were
expressly written herein. Every numerical range given throughout
this disclosure is deemed to include each and every narrower
numerical range that falls within such broader numerical range, as
if such narrower numerical ranges were all expressly written
herein.
[0031] The preceding is a simplified summary of the disclosure to
provide an understanding of some aspects of the disclosure. This
summary is neither an extensive nor exhaustive overview of the
disclosure and its various aspects, embodiments, and
configurations. It is intended neither to identify key or critical
elements of the disclosure nor to delineate the scope of the
disclosure but to present selected concepts of the disclosure in a
simplified form as an introduction to the more detailed description
presented below. As will be appreciated, other aspects,
embodiments, and configurations of the disclosure are possible
utilizing, alone or in combination, one or more of the features set
forth above or described in detail below
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The accompanying drawings are incorporated into and form a
part of the specification to illustrate several examples of the
present disclosure. These drawings, together with the description,
explain the principles of the disclosure. The drawings simply
illustrate preferred and alternative examples of how the disclosure
can be made and used and are not to be construed as limiting the
disclosure to only the illustrated and described examples. Further
features and advantages will become apparent from the following,
more detailed, description of the various aspects, embodiments, and
configurations of the disclosure, as illustrated by the drawings
referenced below.
[0033] FIG. 1 shows an exemplary patient vasculature in section
with implanted lead and multiple locations of tissue growth in
accordance with some embodiments of the present disclosure;
[0034] FIG. 2A shows a detail section view of a patient vasculature
and implanted lead subjected to a traction force in a first path in
accordance with some embodiments of the present disclosure;
[0035] FIG. 2B shows a detail section view of a patient vasculature
and implanted lead subjected to a traction force in second path in
accordance with some embodiments of the present disclosure;
[0036] FIG. 2C shows a detail section view of a patient vasculature
and implanted lead subjected to a traction force in third path in
accordance with some embodiments of the present disclosure;
[0037] FIG. 3 shows a section view of a curved area of vasculature
with tissue growth formed around an implanted lead in accordance
with embodiments of the present disclosure;
[0038] FIG. 4 shows a cross-sectional view of the curved area of
vasculature of FIG. 3 taken along line A-A;
[0039] FIG. 5A shows a cross-sectional view of an area of
vasculature with a tissue slitting device introduced in accordance
with embodiments of the present disclosure;
[0040] FIG. 5B shows a cross-sectional view of an area of
vasculature with a tissue slitting device engaging formed tissue in
accordance with embodiments of the present disclosure;
[0041] FIG. 5C shows a cross-sectional view of an area of
vasculature with a tissue slitting device slitting formed tissue in
accordance with embodiments of the present disclosure;
[0042] FIG. 6A shows a section view of a curved area of vasculature
with a tissue slitting device first introduced in accordance with
embodiments of the present disclosure;
[0043] FIG. 6B shows a section view of a curved area of vasculature
with a tissue slitting device in a first slitting position in
accordance with embodiments of the present disclosure;
[0044] FIG. 6C shows a section view of a curved area of vasculature
with a tissue slitting device in a second slitting position in
accordance with embodiments of the present disclosure;
[0045] FIG. 6D shows a section view of a curved area of vasculature
with a tissue slitting device in a third slitting position in
accordance with embodiments of the present disclosure;
[0046] FIG. 7A shows a section view of a tissue slitting device in
accordance with embodiments of the present disclosure;
[0047] FIG. 7B shows a perspective view of the tissue slitting
device of FIG. 7A;
[0048] FIG. 8 shows a perspective view of a tissue slitting device
in accordance with embodiments of the present disclosure;
[0049] FIG. 9A shows a plan view of a tissue slitting device in
accordance with embodiments of the present disclosure;
[0050] FIG. 9B shows an end view of a tissue slitting device in
accordance with embodiments of the present disclosure;
[0051] FIG. 10 shows a first embodiment of a tissue slitting device
inside an area of vasculature having formed tissue surrounding an
implanted lead in accordance with embodiments of the present
disclosure;
[0052] FIG. 11 shows a second embodiment of a tissue slitting
device inside an area of vasculature having formed tissue
surrounding an implanted lead in accordance with embodiments of the
present disclosure;
[0053] FIG. 12 shows a third embodiment of a tissue slitting device
inside an area of vasculature having formed tissue surrounding an
implanted lead in accordance with embodiments of the present
disclosure;
[0054] FIG. 13 shows a fourth embodiment of a tissue slitting
device inside an area of vasculature having formed tissue
surrounding an implanted lead in accordance with embodiments of the
present disclosure;
[0055] FIG. 14A shows a first configuration of a fifth embodiment
of a tissue slitting device inside an area of vasculature having
formed tissue surrounding an implanted lead in accordance with
embodiments of the present disclosure;
[0056] FIG. 14B shows a second configuration of the fifth
embodiment of a tissue slitting device inside an area of
vasculature having formed tissue surrounding an implanted lead in
accordance with embodiments of the present disclosure;
[0057] FIG. 15A shows a first configuration of a sixth embodiment
of a tissue slitting device inside an area of vasculature having
formed tissue surrounding an implanted lead in accordance with
embodiments of the present disclosure;
[0058] FIG. 15B shows a second configuration of a sixth embodiment
of a tissue slitting device inside an area of vasculature having
formed tissue surrounding an implanted lead in accordance with
embodiments of the present disclosure;
[0059] FIG. 16 shows a seventh embodiment of a tissue slitting
device inside an area of vasculature having formed tissue
surrounding an implanted lead in accordance with embodiments of the
present disclosure;
[0060] FIG. 17 shows an eighth embodiment of a tissue slitting
device inside an area of vasculature having formed tissue
surrounding an implanted lead in accordance with embodiments of the
present disclosure;
[0061] FIG. 18 shows a ninth embodiment of a tissue slitting device
inside an area of vasculature having formed tissue surrounding an
implanted lead in accordance with embodiments of the present
disclosure;
[0062] FIG. 19A shows a perspective view of a tenth embodiment of a
tissue slitting device in accordance with embodiments of the
present disclosure;
[0063] FIG. 19B shows a section view of the tissue slitting device
of FIG. 19A;
[0064] FIG. 20 shows an eleventh embodiment of a tissue slitting
device inside an area of vasculature having formed tissue
surrounding an implanted lead in accordance with embodiments of the
present disclosure;
[0065] FIG. 21 shows an end view of a twelfth embodiment of a
tissue slitting device in accordance with embodiments of the
present disclosure;
[0066] FIG. 22 shows an end view of a thirteenth embodiment of a
tissue slitting device in accordance with embodiments of the
present disclosure;
[0067] FIG. 23 shows an end view of a fourteenth embodiment of a
tissue slitting device in accordance with embodiments of the
present disclosure;
[0068] FIG. 24 shows an end view of a fifteenth embodiment of a
tissue slitting device in accordance with embodiments of the
present disclosure;
[0069] FIG. 25 shows an end view of a sixteenth embodiment of a
tissue slitting device in accordance with embodiments of the
present disclosure;
[0070] FIG. 26 shows a seventeenth embodiment of a tissue slitting
device inside an area of vasculature having formed tissue
surrounding an implanted lead in accordance with embodiments of the
present disclosure;
[0071] FIG. 27 is a flow diagram depicting a tissue slitting method
in accordance with embodiments of the present disclosure; and
[0072] FIG. 28 shows an embodiment of a grinding tissue slitting
device inside an area of vasculature having formed tissue
surrounding an implanted lead in accordance with embodiments of the
present disclosure.
[0073] It should be understood that the drawings are not
necessarily to scale. In certain instances, details that are not
necessary for an understanding of the disclosure or that render
other details difficult to perceive may have been omitted. It
should be understood, of course, that the disclosure is not
necessarily limited to the particular embodiments illustrated
herein.
DETAILED DESCRIPTION
[0074] Before any embodiments of the disclosure are explained in
detail, it is to be understood that the disclosure is not limited
in its application to the details of construction and the
arrangement of components set forth in the following description or
illustrated in the following drawings. The disclosure is capable of
other embodiments and of being practiced or of being carried out in
various ways. Also, it is to be understood that the phraseology and
terminology used herein is for the purpose of description and
should not be regarded as limiting. The use of "including,"
"comprising," or "having" and variations thereof herein is meant to
encompass the items listed thereafter and equivalents thereof as
well as additional items.
[0075] Embodiments of the present disclosure are directed to tissue
slitting or cutting devices and methods of using tissue slitting
devices to remove an implanted lead from within the vascular system
of a patient. Among other things, the method of removing an
implanted lead from formed tissue may include causing at least a
partial separation of tissue that lies along an axial length of the
implanted lead. In some embodiments, the tissue may be slit or cut
along an entire length of the tissue growth to enable removal of
the implanted lead. In other embodiments, the tissue may be slit or
cut along a section of the tissue growth to allow an implanted lead
to be removed from a patient.
[0076] While the phrases "tissue slitting edge" or "tissue cutting
edge" are used in this disclosure, it is not limited to a blade or
other cutting surface. These phrases are further intended to
encompass any modality for slitting or cutting tissue, including
the various modalities discussed herein. Nonlimiting examples
include not only a sharpened area, point, or blade but also an
abrasive or cutting wire or fiber, atherotomes (microsurgical
blades) mounted on an inflatable (cutting) balloon, a grinder, high
intensity light such as produced by a laser, thermal or infrared
energy, electromagnetic energy, and/or high-pressure fluid.
[0077] FIG. 1 depicts an exemplary patient 102 with an implanted
lead 104 running along the left innominate vein 112 past the
superior vena cava ("SVC") and connected into, or about, the right
ventricle of the heart 106. Along the length of the lead 104 at
least one formed tissue growth 108 is shown where the tissue 108
may completely surround a section of the lead 104. In a typical
lead 104 explant procedure, the one or more of the tissue growths
108 may act to contain the lead 104. For example, the tissue 108
may impart one or more forces (e.g., constrictive, shear,
compression, and the like) on the lead 104 that may act to prevent
successful removal of the lead 104 when subjected to a traction
force 120.
[0078] FIGS. 2A-C show examples of an implanted lead 104 subjected
to a traction force via different paths in a patient 102
vasculature. Accordingly, the methods and/or devices disclosed in
conjunction with any of the FIGS. 2A-C may equally apply to all
instances disclosed.
[0079] FIG. 2A shows a detail view of a heart 106 having an
implanted lead 104 subjected to a traction force 120 in a first
path in accordance with embodiments of the present disclosure. In
some embodiments, a lead 104 explant procedure may involve removing
the lead from a patient 102 via one or more paths. For example, a
lead-locking, or other traction, device may be engaged with the
lead 104 and then used to pull the lead 104 from a patient.
However, in some cases the lead 104 may be contained by a formed
tissue growth 108 that resists the traction force 120 applied to
the lead 104. As can be appreciated, subjecting the lead 104 to
excessive traction forces 120 may cause a tear inside the patient
102 where the tissue is attached to the vasculature. In one
example, a tissue growth 108 may form along a critical area of the
vasculature, such as the SVC curve 116, of a patient. If this
critical area is torn during a lead 104 explant procedure, the
result can be fatal to the patient 102.
[0080] Complicating the lead 104 removal process is the fact that
the tissue growth 108 surrounding a lead 104 may attach to a vessel
in a curved portion of the vasculature. Removal of the lead 104
from such a curved portion of vasculature can present a challenge
when introducing tissue removal devices alone or in conjunction
with traction devices. In some cases, the tissue removal devices
include sharp edges, aggressive tips, or imprecise actuation
mechanisms that can puncture the thin walls of a patient 102
vasculature. It is an aspect of the present disclosure to orient a
tissue slitting working end adjacent to the unconnected, or tissue
free, side 124 of a vessel wall. This orientation can prevent
puncture and/or damage occurring to the vasculature at the tissue
connected side 128 of the vessel wall.
[0081] Referring now to FIG. 2B a detail section view of a patient
vasculature and implanted lead 104 subjected to a traction force
120 in second path in accordance with some embodiments of the
present disclosure is shown. In some instances, at least one end of
the lead 104 may be directed inside a patient 102 for removal via a
path within the vasculature. Direction of the lead 104 may be
affected via a snaring tool, lead-locking device, traction device,
combinations thereof, and the like. As shown in FIG. 2B, the lead
104 is directed toward the general direction of a patient's femoral
artery via the inferior vena cava. The lead 104 may be directed in
the manner shown to provide additional tearing forces on the tissue
growth 108 by the lead 104 being subjected to a traction force 120.
In one embodiment, the tissue growth 108 may be at least partially
slit and the tearing forces created by pulling the lead 104 along
the traction force 120 line cause the lead 104 to separate from the
tissue growth 108. In other embodiments, a tissue slitting device
may be run along the lead 104 to the tissue growth 108 via the
femoral artery.
[0082] In some embodiments, the lead 104 may be captured and pulled
such that the pull force causes the lead 104 to turn inside a
patient 102. This mode of capture and pulling may cause a bending
at a first connection point between the tissue growth 108 and the
lead 104. When the tissue slitting device is engaged with the
tissue growth 108, the assistive bending force provided by the
traction force 120 can aid in slitting the tissue growth 108. For
instance, the bending force may cause a stretching of the tissue
growth 108 where the lead engages with the tissue growth 108. This
stretching of tissue may assist in the slitting operation by
causing tension on the fibers of the tissue growth 108 that, when
slit, pull away from the tissue slitting device engagement area. As
can be expected, the slitting operation may be performed in any
area within a patient that is capable of receiving a tissue
slitting device.
[0083] FIG. 2C shows a detail section view of a patient vasculature
and implanted lead 104 subjected to a traction force 120 in third
path in accordance with some embodiments of the present disclosure.
Similar to FIGS. 2A and 2B, the lead 104 may be directed along a
path in the patient vasculature. In this case, the lead 104 may be
directed toward the general direction of a patient's jugular
vein.
[0084] As can be appreciated, the path chosen for removal of a lead
104 from a patient 102 may depend on one or more of the orientation
of the lead 104 within a patient 102, the state of the at least one
tissue growth 108, the lead removal device used, and the tissue
slitting device used. In some cases, the lead 104 (e.g., pacing,
defibrillator, etc.), or other object, may have moved after
implantation. In these scenarios, the lead 104 may have to be
captured via some other method. In some embodiments, a capturing
tool equipped with a lasso, snare, or other lead grasping element
may need to be inserted into the patient 102. As can be expected,
the capturing tool may be inserted into the patient 102 via any
number of the veins and/or arteries that are interconnected to the
lead 104 location in the vasculature. For example, the lead 104 may
be grasped via a capturing tool that has been inserted through a
patient's femoral artery and led to the point of the vasculature
where the lead's 104 free end may be located.
[0085] In some embodiments, rather than attach a separate
mechanical traction device, the capturing tool may be used to
provide traction force 120 during the tissue slitting operation. In
accordance with embodiments of the present disclosure, the lead may
be grasped via a capturing tool, or lead-locking device, and/or
removed via some other pathway in the vasculature. In other words,
the lead may be accessed via one or more veins, arteries, chambers,
biological channels, and/or other sections of the vasculature of a
patient 102.
[0086] FIG. 3 shows a section view of a curved area of vasculature
with tissue growth 108 formed around an implanted lead 104 in
accordance with embodiments of the present disclosure. The tissue
growth 108 may completely surround a section of the lead 104 and
even be attached to a vessel wall at a tissue connected side 128 of
the vasculature. In some cases, the tissue growth 108 may not be
adhered to at least one free side 124 of a vessel, such that a
vessel opening 126 exists where bodily fluid may pass through the
vessel unobstructed. Surprisingly and unexpectedly, it has been
discovered that the tissue growth 108, before attempted lead
extraction, is commonly at least substantially free of and even
more commonly completely free of attachment to the lead 104.
[0087] FIG. 4 shows a cross-sectional view of the curved area of
vasculature of FIG. 3 taken along line A-A. In some embodiments,
reference may be made to the tissue growth 108 forming a tube 132
(or cylindrical or sock-like structure) around the implanted lead
104. Previous methods have been disclosed that are directed to
separating the tissue around the lead 104 in the area defined by
the tube 132. It is an aspect of the present disclosure to provide
one or more methods and devices to effectively separate the tissue
growth 108 along a length of the lead to release the lead 104 from
the containing forces of the tissue growth 108. In some
embodiments, the tissue growth 108 may be slit at a portion of the
tissue growth 108 where the thickness of tissue is minimal between
the lead 104 and the open area 126 of the vessel.
[0088] In embodiments disclosed herein, the tissue growth 108 may
be subjected to a slitting action about a partial (i.e., not
complete) periphery of an internal diameter of the tissue growth
108. Stated another way, at any selected point along the tissue
growth 108 or tube 132 the amount of the adjacent tissue cut or
slit 130 to free the lead 104 is commonly no more than about 50%,
more commonly no more than about 25%, more commonly no more than
about 10%, and even more commonly no more than about 5% of the
diameter of the tissue growth 108 or tube 132. The length of the
cut or slit 130 in the tissue growth 108 or tube 132 is commonly at
least about 50%, more commonly at least about 75%, more commonly at
least about 90%, and even more commonly at least about 95% of the
total length of the portion of the lead 104 surrounded by the
tissue growth 108 or tube 132 along an actual and projected line of
the cut or slit.
[0089] FIGS. 5A-C show a cross-section of a vessel where a tissue
slitting device 504 is progressively engaged with a tissue growth
108. As shown, the tissue slitting device causes a section of the
tissue growth 108 to separate from a portion of the lead 104
allowing the forces containing the lead 104 to be severely weakened
and/or eliminated.
[0090] Referring to FIG. 5A a cross-sectional view of an area of
vasculature with a tissue slitting device 504 introduced therein in
accordance with embodiments of the present disclosure is shown. The
tissue slitting device 504 includes a tissue slitting tip 508 that
is configured to separate tissue growth 108. In one embodiment, the
tissue slitting tip 508 may be oriented such that a slitting
operation is performed on the thinnest section of tissue growth 108
between the lead 104 and the open area 126 of the vessel.
Orientation of the tissue slitting device 504 may be achieved in
operation via a fluoroscopy and/or other monitoring devices and the
use of one or more radiopaque markers on the tissue slitting device
504. Once the tissue slitting device 504 is oriented, the tissue
slitting device 504 may contact the tissue growth 108 at an
engagement area 510.
[0091] In any of the embodiments disclosed herein, the tissue
slitting device may include an imaging system configured to provide
an image from within the vasculature of a patient 102. It is
anticipated that the imaging system may be disposed adjacent to the
distal tip of the tissue slitting device. Examples of such imaging
systems may include, but are in no way limited to, technology
incorporating Intravascular Ultrasound ("IVUS"), Optical Coherence
Tomography ("OCT"), radio imaging, magnetic tracking,
three-dimensional ("3D") imaging, and other technologies that may
be used to obtain an image within a patient.
[0092] FIG. 5B shows a cross-sectional view of an area of
vasculature with a tissue slitting device 504 engaging formed
tissue 108 in accordance with embodiments of the present
disclosure. As the tissue slitting device 504 engages the tissue
growth 108 the tissue slitting device 504, may slit the tissue
growth 108 by splitting, cutting, tearing, grinding, sanding,
ablating, and/or otherwise causing a separation of tissue at the
engagement area 510.
[0093] FIG. 5C shows a cross-sectional view of an area of
vasculature with a tissue slitting device 504 slitting formed
tissue 108 in accordance with embodiments of the present
disclosure. As shown in FIG. 5C, the tissue growth 108 is separated
along a section of the lead 104 about the engagement area 510. In
some embodiments, the tissue slitting device may be subsequently
removed from the tissue growth 108 by moving the lead 104 in the
direction of the separated tissue.
[0094] FIGS. 6A-D show a section view of a curved area of
vasculature where an embodiment of a tissue slitting device 604 is
progressively engaged with a tissue growth 108. As shown, the
tissue slitting device 604 causes a section of the tissue growth
108 to separate from a portion of the lead 104 allowing the forces
containing the lead 104 to be severely weakened and/or
eliminated.
[0095] FIG. 6A shows a section view of a curved area of vasculature
with a tissue slitting device 604 first introduced in accordance
with embodiments of the present disclosure. The tissue slitting
device 604 is indexed into position via a directional force 618
adjacent to the tissue growth 108. The directional force 618 may be
applied to the tissue slitting device 604 via one or more
mechanical actuators, electrical actuators, manual positioning, and
combinations thereof.
[0096] In some embodiments, the tissue slitting device 604 includes
a flexible shaft having a proximal end, a distal end 612, and an
internal lumen 616 having an internal diameter configured to allow
a lead, lead locking device, and/or other implanted device to pass
through it. The device may also include a tissue slitting tip 608
operatively attached to the distal end 612 of the flexible shaft.
As can be appreciated, the slitting of formed tissue can be
performed by at least one of cutting, drilling, slicing, stripping,
chopping, sanding, grinding, planing, abrasion, high-pressure
fluid, laser ablation, and combinations thereof. It is anticipated
that the tissue slitting device 604 may be oriented within a
patient via use of the flexible shaft and monitor, or a
catheter-based system. In some cases, the tissue slitting device
604 may be positioned toward the center of the vasculature, and/or
proximal to a non-traumatic leading edge, such that any sharp, or
working, edge is caused to contact tissue growth 108 and not
contact the vasculature (e.g., the tissue connected side 128 wall
and the free side 124 wall of a vessel).
[0097] Additionally or alternatively, the tissue slitting tip 608
and effective slitting section of the tissue slitting device 604
may be biased against a lead 104 via spring force. In some
embodiments, the tissue slitting device 604 may include a flexible
portion configured to allow the tissue slitting device 604 to move
as directed within a patient.
[0098] FIG. 6B shows a section view of a curved area of vasculature
with a tissue slitting device 604 in a first slitting position in
accordance with embodiments of the present disclosure. As the
tissue slitting device 604 is directed into the tissue growth 108,
the tissue slitting tip 608 causes the tissue growth 108 to
separate along the engagement area 610. The separated tissue 614
allows the tissue slitting device 604 to be further engaged with
the tissue growth 108. Additionally or alternatively, the separated
tissue 604, by releasing forces containing the lead, can allow the
lead 104 to be moved about the area of the tissue slitting tip
608.
[0099] FIG. 6C shows a section of a curved area of vasculature with
the tissue slitting device 604 in a second slitting position in
accordance with embodiments of the present disclosure. As the
tissue slitting device 604 is indexed in a direction 618 into the
tissue growth 108 the tissue slitting device 604 separates tissue
along an axial length of at least one side of the lead 104. In some
embodiments, the lead 104 may be subjected to a traction force 120
that may be opposite to the index direction 618 of the tissue
slitting device 604. This applied traction force 120 may assist in
pulling the lead 104 away from the tissue growth 108 as the lead
104 is separated from containing tissue growth 108.
[0100] FIG. 6D shows a section view of a curved area of vasculature
with a tissue slitting device 604 in a third slitting position in
accordance with embodiments of the present disclosure. In general,
the tissue slitting device 604 is indexed further into the tissue
growth 108 such that the tissue growth 108 is almost completely
separated from the lead 104 along a length of the tissue growth
108. In some embodiments, slitting at least a portion of the tissue
growth 108 may allow the lead 104 to be removed in an explant
procedure. For instance, the lead 104 may be subjected to a
traction force 120 to pull the lead 104 away from any remaining the
tissue growth 108. Additionally or alternatively, the lead 104 may
be pulled against the remaining tissue growth 108 that surrounds
the lead 104. In other embodiments, the tissue slitting device 604
may be indexed along the entire length of the tissue growth 108 to
completely separate the tissue growth 108 from encapsulating, or
surrounding, the lead 104.
[0101] Cutting Embodiments:
[0102] FIGS. 7A-12 are directed to embodiments of a tissue slitting
device that include one or more cutting features that are
configured to cut at least a portion of a tissue growth 108 along a
lead 104 implanted in a patient 102. FIGS. 10-12 show embodiments
of the tissue slitting device inside an area of vasculature where
an implanted lead 104 is encapsulated by a tissue growth 108. In
addition to surrounding the lead 104 along a section, the tissue
growth 108 is connected to a portion of the vessel wall.
[0103] In any of the embodiments disclosed herein the cutting
surface may be guarded by a mechanical sheath. A mechanical sheath
may include at least one surface that acts to guard and/or protect
a cutting surface from being accidentally exposed to one or more
sensitive areas of the vasculature during navigation of a tissue
slitting device within a patient 102. In one embodiment, a
mechanical sheath may at least partially shroud a portion of a
cutting surface with a compliant material (e.g., silicone,
polyurethane, rubber, polymer, combinations thereof, and the like).
It is anticipated that the compliant material may be compressed
when subjected to an operation force. The compression of the
compliant material may subsequently expose the cutting surface of
the tissue slitting device.
[0104] In another embodiment, the mechanical sheath may include a
non-compliant material (e.g., metal, carbon fiber, plastic, resin,
combinations thereof, and the like) that is configured to at least
partially shroud a portion of a cutting surface. The non-compliant
material mechanical sheath may be configured to at least partially
shroud the cutting surface via a compliant member (e.g., spring,
flexure, compliant material, combinations thereof, etc.) in
connection with the non-compliant member that maintains a shrouded
position of the non-compliant material mechanical sheath. Upon
subjecting the non-compliant material mechanical sheath to an
operational force, the operational force may be directed to the
compliant member, which subsequently exposes the cutting surface
from the mechanical sheath.
[0105] Referring now to FIGS. 7A and 7B a tissue slitting device
704 is shown in accordance with embodiments of the present
disclosure. In some embodiments, the tissue slitting device 704
comprises an inner lumen 716, at least one cutting surface, or
knife-edge 708, a wedge tapered section 720, and a tapered section
transition 724. The inner lumen 716 can be disposed between the
proximal and distal end of the tissue slitting device 704. In some
embodiments, the inner lumen 716 may be configured to allow a lead
104 and/or other objects to pass therethrough (e.g., a lead-locking
device, fraction device, snare tool, etc.). As can be appreciated,
the tissue slitting device 704 may be indexed and/or guided along
the lead 104 via the inner lumen 716 of the device 704.
[0106] The tissue slitting device 704 may be configured to engage
with the tissue growth 108 in a patient 102 at a distal tip 712 of
the device 704. In some embodiments, the distal tip 712 of the
device may be equipped with a knife-edge 708 configured to cut the
tissue growth 108. Additionally, the knife-edge 708 may be
configured to part the tissue as it cuts. In other words, the
knife-edge 708 of the distal tip 712 may include a wedge shape 720.
As the knife-edge 708 is moved into the tissue growth 108, the
cutting surface of the knife-edge 708 may sever the tissue while
simultaneously parting it along the wedge shape 720 of the device
704. In some embodiments, the wedge shape 720 may cause a parting
of separated tissue and bias the cutting surface of the knife-edge
708 against remaining tissue growth 108 attached to the lead 104.
Additionally or alternatively, the wedge shape 720 may be
configured as a scalloped shape that can provide added strength to
the structure of the distal tip 712 of the tissue slitting device
704.
[0107] In some embodiments, the distal tip 712 of the tissue
slitting device 704 includes a knife-edge 708 disposed at the most
distal portion of the tip 712 and a tapered wedge section 720
proximal to the knife-edge 708. The tapered wedge section 720 may
be configured in one or more shapes designed to slope proximal from
the knife-edge 708 distal end. The proximal end point of the
tapered wedge section may include a smooth surface 724 that
transitions from the tapered slope angle of the tip to the
circumferential surface of the device 704. In some embodiments, the
smooth surface 724 may include a radius joining the circumferential
surface with the distal tip 712. The taper and/or radius may be
configured to reduce trauma during navigation through the
vasculature and/or during the cutting of tissue.
[0108] In any of the embodiments disclosed herein, the taper
associated with the distal tip of the tissue slitting device may be
configured with various shapes, angles, and dimensions. In one
embodiment, the taper may be arranged at an angle ranging from 10
to 50 degrees from a plane that is coincident with at least two
points on an axis running along the lumen of the tissue slitting
device. As can be appreciated, the tapered section of the distal
tip of the tissue slitting device may be defined by its axial
length from the distal end. In one embodiment, the axial length of
the tapered section of the distal tip may range from 0.025'' to
0.500''. In another embodiment, the axial length of the tapered
section of the distal tip may range from 0.050'' to 0.300''.
[0109] FIG. 8 shows a perspective view of a tissue slitting device
804 in accordance with embodiments of the present disclosure. In
some embodiments, the tissue slitting device 804 comprises an inner
lumen 816, at least one cutting surface, or knife-edge 808, a
tapered section 820, and a tapered section transition 824. The
inner lumen 816 may be configured to allow a lead 104 and/or other
objects to pass therethrough (e.g., a lead-locking device, traction
device, snare tool, etc.). As can be appreciated, the tissue
slitting device 804 may be indexed and/or guided along the lead 104
via the inner lumen 816 of the device 804. In one embodiment, the
knife-edge 808 may at least partially surround the leading edges
828 adjacent to the knife-edge 808 at the distal portion of the
tissue slitting device 804. In other embodiments, the knife-edge
808 may completely surround the leading edges at the distal portion
of the tissue slitting device 804. As can be appreciated,
embodiments of the present disclosure anticipate including a
sufficiently sharp portion of the knife-edge configured to slit
tissue. For example, some leads 104, or implanted devices may
include dual-coils, exposed coils, and/or other undulating
geometry. As such, tissue may be caused to form in and/or around
the coils/geometry. It is anticipated that a tissue slitting tip,
or knife-edge 808, with an extended blade portion 828 disposed at
least partially around its distal circumference may remove this
additionally formed tissue growth 108.
[0110] FIGS. 9A and 9B show a tissue slitting device 904 showing
various cutting surface locations in accordance with embodiments of
the present disclosure. In some embodiments, the tissue slitting
device 904 comprises an inner lumen 916, at least one cutting
surface, or knife-edge 908, a tapered section 920, and a tapered
section transition 924. As shown in FIG. 9A, it is anticipated that
the knife-edge 908 may be disposed at a distal end of the tissue
slitting device 904. In other words, the knife-edge 908 may be
oriented at a leading edge of a tissue slitting device 904. In one
embodiment, and as shown in FIG. 9B, the knife-edge 908 may be
disposed at least partially inside the lumen 916 of the tissue
slitting device 904.
[0111] Additionally, tissue slitting devices disclosed herein may
include at least one fluorescing material or marker (e.g.,
radiopaque band, marker, and the like). In some embodiments, the
radiopaque marker may be arranged about and/or adjacent to a
knife-edge 908 of the tissue slitting device 904. The radiopaque
marker, may assist in identifying a location of the knife-edge 908
via a monitoring device. Examples of radiopaque markers may
include, but are in no way limited to, materials and/or particles
containing tantalum, tungsten, carbide, iridium, bismuth oxide,
barium sulfate, cobalt, platinum and/or alloys and combinations
thereof. In some embodiments, the inner lumen 916 may be configured
to allow a lead 104 and/or other objects to pass therethrough
(e.g., a lead-locking device, traction device, snare tool, etc.).
As can be appreciated, the tissue slitting device 904 may be
indexed and/or guided along the lead 104 via the inner lumen 916 of
the device 904. Referring to FIG. 9B, a knife-edge 908 is oriented
at least partially within the lumen 916 of the tissue slitting
device 904, which may allow the device 904 to be routed through the
vasculature of a patient 102 without presenting sharp edges,
cutting surfaces, or knife-edges 908 toward sensitive areas. The
knife-edge 908 oriented at least partially within the lumen 916 of
the tissue slitting device 904 may allow the cutting surface of the
knife-edge 908 to be biased toward the tissue growth 108 in
connection with the lead 104. In another embodiment, the knife-edge
908 may be configured as a blade positioned perpendicular to the
outer circumferential surface of the lead. The blade may be
spring-loaded and/or arranged such that lead 104 is pushed against
the blade when the tissue slitting device 904 is actuated along the
axial length of the lead 104. Additionally, the blade may be
equipped with a wedge 920 to peel the tissue away as it is being
cut by the blade portion. Additionally or alternatively, the angle
of the blade relative to the axis, and/or outer circumferential
surface, of the lead 104 may be configured to achieve an adequate
cutting angle in the tissue growth 108, such that the tissue 108 is
slit in a manner to best achieve lead 104 removal. That is, due to
the overall size of the lumen, a small angle itself may create a
sharp leading edge sufficient to cut and slit the tissue growth
108. The angle may also create smooth translation and slitting of
the remainder of the tissue as the tissue slitting device 904
traverses longitudinally along a direction of the lead 104.
[0112] Referring now to FIG. 10, a first embodiment of a tissue
slitting device 1004 inside an area of vasculature having tissue
growth 108 surrounding an implanted lead 104 is shown in accordance
with embodiments of the present disclosure. In some embodiments,
the tissue slitting device 1004 comprises an inner lumen 1016, at
least one cutting surface 1008, a tapered section 1020, and a
tapered section transition 1024. The inner lumen 1016 may be
configured to allow a lead 104 and/or other objects to pass
therethrough (e.g., a lead-locking device, traction device, snare
tool, etc.). As can be appreciated, the tissue slitting device 1004
may be indexed and/or guided along the lead 104 via the inner lumen
1016 of the device 1004. In one embodiment, a cutting surface
(e.g., a blade) 1008 may be disposed such that the cutting surface
1008 is tangent to an inner lumen, or opening, 1016 in the
body/sheath of the tissue slitting device 1004 (e.g., similar to a
planing blade). As can be appreciated, the cutting surface 1008 may
be arranged at an angle at the leading edge of the tissue slitting
device 1004. The angle may be configured to present the cutting
surface in the direction of formed tissue that is distally adjacent
to the tip of the tissue slitting device 1004. As the device 1004
is further engaged with the tissue growth 108, the planing-style
blade 1008 may be configured to remove a section of tissue 108
along at least one of a length and width of a lead 104.
[0113] FIG. 11 shows a second embodiment of a tissue slitting
device 1104 inside an area of vasculature having tissue growth 108
surrounding an implanted lead 104 in accordance with embodiments of
the present disclosure. In some embodiments, the tissue slitting
device 1104 comprises an inner lumen 1116, at least one knife-edge
1408, a wedge and/or ramp 1122, a tapered section 1120, and a
tapered section transition 1124. The inner lumen 1116 may be
configured to allow a lead 104 and/or other objects to pass
therethrough (e.g., a lead-locking device, fraction device, snare
tool, etc.). As can be appreciated, the tissue slitting device 1104
may be indexed and/or guided along the lead 104 via the inner lumen
1116 of the device 1104. The knife-edge 1108 may include a blade
that is positioned tangent to the outer circumferential surface of
the lead 104. The blade may be spring-loaded and/or arranged such
that the lead 104 is pushed against the blade when the tissue
slitting device 1104 is actuated along the axial length of the lead
104. Additionally, the knife-edge 1108, or blade, may be equipped
with a wedge, or ramp, 1120 to part the tissue as it is being cut
by the blade. As can be expected, the angle of the blade relative
to the axis of the lead 104 may be configured to achieve an
adequate stripping of tissue growth 108 in a specific area, such
that the tissue 108 is slit at the specific area.
[0114] In some embodiments, the knife-edge 1108 may be mechanically
actuated to assist in cutting tissue growth 108. For instance, the
knife-edge 1108 may be configured to move along an axis defined by
at least one sharp edge of the knife-edge 1108. Actuation of the
knife-edge 1108 may be achieved via a mechanism operatively
connected to the knife-edge 1108 that can move the blade from one
direction along the axis defined by at least one sharp edge to the
opposite direction along the axis defined by the at least one sharp
edge. This oscillating movement may be made at a sub-ultrasonic
frequency. Additionally or alternatively, the oscillating blade may
move at an ultrasonic frequency. In one embodiment, the frequency
of oscillation of the knife-edge 1108 may be adjusted to suit
preferences of the operator.
[0115] In another embodiment, the knife-edge 1108 may be configured
to move along an axis that is perpendicular to an axis created by
the at least one sharp edge of the knife-edge 1108. In other words,
the knife-edge 1108 may be configured to move from a proximal
position to a distal position along the axis of the tissue slitting
device 1104. As can be appreciated, the movement of the knife-edge
1108 may be actuated to repetitively move from the proximal
position to the distal position and back to the proximal position.
This oscillating movement may be made at a sub-ultrasonic
frequency. Additionally or alternatively, the oscillating blade may
move at an ultrasonic frequency. In one embodiment, the frequency
of oscillation of the knife-edge 1108 may be adjusted to suit
preferences of the operator.
[0116] FIG. 12 shows a third embodiment of a tissue slitting device
1204 inside an area of vasculature having formed tissue growth 108
surrounding an implanted lead 104 in accordance with embodiments of
the present disclosure. In some embodiments, the tissue slitting
device 1204 comprises an inner lumen 1216, at least one cutting
surface 1208, a tapered section 1220, a tapered section transition
1224, and a tissue tension taper 1222. The inner lumen 1216 may be
configured to allow a lead 104 and/or other objects to pass
therethrough (e.g., a lead-locking device, fraction device, snare
tool, etc.). As can be appreciated, the tissue slitting device 1204
may be indexed and/or guided along the lead 104 via the inner lumen
1216 of the device 1204. In one embodiment, the cutting surface
1208 of the tissue slitting device 1204 may be oriented proximal to
the leading edge 1226 of the distal tip 1212 of the tissue slitting
device 1204. The cutting surface 1208 may be arranged such that any
sharp edge is concealed behind a smooth and/or dull surface. This
arrangement can allow the tissue slitting device 1204 to be safely
routed within a convoluted vasculature of a patient 102.
Additionally or alternatively, the tapered surfaces 1220, 1222 of
the leading edge 1226 allows the tissue growth to be stretched as
it is engaged and presented to the cutting surface. As disclosed
herein, the stretching of the tissue growth 108 fibers assists in
the cutting operation performed by the tissue slitting device 1204.
Among other things, the tension placed on the tissue growth 108
fibers provide a taught area for the cutting surface 1208 to engage
and cut along. In some embodiments, the leading edge 1226 of the
distal tip 1212 of the tissue slitting device 1204 may comprise a
non-traumatic surface. For example, the leading edge 1226 may
include a non-traumatic surface where at least some of the exposed
sharp edges have been removed (e.g., a ball end, radiused surface,
other curved section, etc.). Additionally or alternatively, the
tapered surface 1222 may include a cutting surface. For instance,
as the tapered surface 1222 wedges into and engages a tissue growth
108, it may simultaneously cut the tissue along the tapered surface
1222 as it stretches the fibers of the tissue growth 108.
[0117] In accordance with embodiments of the present disclosure,
the knife-edge 708, 808, 908, 1008, 1108, 1208 may be advanced into
the tissue growth 108. This advancement may be continuous or
periodic. Additionally or alternatively, the knife-edge 708, 808,
908, 1008, 1108, 1208 may be actuated in a direction toward and
away from the tissue such that the knife-edge 708, 808, 908, 1008,
1108, 1208 is presented to an area of the tissue growth 108,
removed from the area, and represented to an area of the tissue
growth 108 to successively cut the tissue growth 108 over a number
of movements. For example, the tissue growth 108 is cut in a
similar manner to that of an axe chopping at a tree. In any
embodiment disclosed herein, traction force may be applied to the
lead 104 during the cutting of the tissue growth 108. Among other
things, traction force 120 can prevent tears, punctures, and other
catastrophic failures caused by the force exerted on the tissue
growth and/or adjacent vasculature by the tissue slitting device
704, 804, 904, 1004, 1104, 1204.
[0118] It is anticipated that the knife-edge may be manufactured
from a material with a suitable hardness for slitting tissue. In
some embodiments, the knife-edge 708, 808, 908, 1008, 1108, 1208
may be manufactured from a polymeric material with a durometer
configured to cut a patient's tissue. Examples of polymeric
material may include, but are not limited to, plastics, silicone,
polytetrafluoroethylene ("PTFE"), polyethylene, polyurethane,
polycarbonate, polypropylene, polyvinyl chloride ("PVC"),
polystyrene, acetal, polyacetal, acetal resin, polyformaldehyde,
and the like. In one embodiment, the knife-edge 708, 808, 908,
1008, 1108, 1208 may be constructed from a crystalline or amorphous
metal alloy. The knife-edge 708, 808, 908, 1008, 1108, 1208 may
comprise at least a portion of the distal tip of the tissue
slitting device 704, 804, 904, 1004, 1104, 1204. As can be
appreciated, the knife-edge 708, 808, 908, 1008, 1108, 1208 may
comprise a metal insert. Examples of knife-edge 708, 808, 908,
1008, 1108, 1208 metals may include, but are not limited to, steel,
stainless steel (e.g., austenitic type 304, 316, martensitic type
420, 17-4, etc.), aluminum, titanium, tungsten carbide, silver,
platinum, copper, and combinations thereof. In one embodiment, the
metal may be hardened to, among other things, maintain a sharp edge
during the tissue slitting process.
[0119] Additionally or alternatively, the knife-edge 708, 808, 908,
1008, 1108, 1208 or cutting surface may be removably attached to
the distal tip of the tissue slitting device 704, 804, 904, 1004,
1104, 1204. Benefits of a removably attached knife-edge 708, 808,
908, 1008, 1108, 1208 allow for quick replacement of cutting
surfaces during lead removal procedures. As can be appreciated, the
replacement of the cutting surface may be initiated upon detecting
that the cutting surface is dulling. In some cases the cutting
surface may be replaced with a different style of blade. The style
of blade may be configured to suit a number of desires, including
but not limited to, navigating difficult areas in a patient (e.g.,
using a curved blade, etc.), cutting difficult, dense, and/or hard
tissue (e.g., using a serrated blade, a hardened blade, and
combinations thereof, etc.), cutting tissue in confined and/or
low-growth areas (e.g., using a miniature blade), and even removing
the blade completely (e.g., using the tissue slitting device as a
counter-traction sheath, etc.).
[0120] In some embodiments, the tissue slitting devices disclosed
herein may include at least one non-traumatic leading edge disposed
at the most distal end of the device. The non-traumatic leading
edge may include a distal end and a proximal end. Non-traumatic
surfaces on the leading edge of the device may include but are not
limited to, spheroidal, ball-nose, radiused, smooth, round, and/or
other shapes having a reduced number of sharp edges. These
non-traumatic surfaces may be configured to prevent accidental
puncture or harmful contact with the patient 102. The non-traumatic
leading edge may be configured to include a tapered and/or a
wedge-shaped portion. In some cases the cross-sectional area of the
tapered portion increases along a length of the non-traumatic
leading edge from the distal end to the proximal end of the leading
edge. A knife-edge and/or cutting surface may be disposed proximal
to or along the tapered portion of the non-traumatic leading edge
of the tissue slitting device.
[0121] The non-traumatic leading edge may be positioned to insert
into an area between the tissue growth 108 and the implanted lead
104. In some cases the tapered geometry and the arrangement of the
tissue slitting device tip may allow the most distal portion of the
non-traumatic leading edge to bias against the lead 104 and wedge
under any surrounding tissue growth 108. As the non-traumatic
leading edge is indexed further into the tissue growth 108, the
tissue growth is caused to stretch and pull away from the lead 104.
Once the non-traumatic leading edge is engaged with the tissue
growth 108, the cutting surface of the tissue slitting device may
be caused to slit the tissue along a length of the tissue growth.
As can be appreciated, the cutting surface may include but is not
limited to one or more knife-edge and/or cutting devices disclosed
herein.
[0122] Actuated Slitting Embodiments:
[0123] FIG. 13 shows a fourth embodiment of a tissue slitting
device 1304 inside an area of vasculature having formed tissue
growth 108 surrounding an implanted lead 104 in accordance with
embodiments of the present disclosure. In some embodiments, the
tissue slitting device 1304 comprises an inner lumen 1316, at least
one reciprocating cutting blade 1308, a reciprocating blade
actuation element 1310, a tapered section 1320, and a tapered
section transition 1324. The inner lumen 1316 may be configured to
allow a lead 104 and/or other objects to pass therethrough (e.g., a
lead-locking device, traction device, snare tool, etc.). As can be
appreciated, the tissue slitting device 1304 may be indexed and/or
guided along the lead 104 via the inner lumen 1316 of the device
1304. In one embodiment, the knife-edge may be configured as a
reciprocating blade 1308. In other words, the knife-edge may be
configured to move back-and-forth in an axial direction 1318. This
actuation may be independent of the movement of the outer shaft of
the device 1304. The reciprocating motion of the blade 1308 may be
achieved via a reciprocating actuator that is operatively connected
proximal to the distal tip. The reciprocating actuator may be an
electrical motor that is located at the proximal end of the
flexible shaft. In some embodiments, the reciprocating actuator may
be manually operated via a mechanical movement at the proximal end
of the flexible shaft. In any event, energy from the actuator may
be transferred to the blade 1308 via an actuation element 1310. It
is anticipated that the actuation element 1310 may comprise one or
more of a shaft, rod, bar, link, and the like, that is configured
to transmit force from the proximal end of the tissue slitting
device 1304 to the blade 1308.
[0124] In one embodiment, the reciprocating blade 1308 may be
configured to move a cutting surface horizontal to the central axis
of the tissue slitting device. In other words, rather than
reciprocating along an axis of the tissue slitting device, as
previously disclosed, the reciprocating blade in this embodiment
may operate across (or side-to-side) the distal tip of the tissue
slitting device. Additionally or alternatively, the actuation of
the blade 1308, whether axial or side-to-side, may be provided at a
frequency below 20 kHz. In some embodiments, the actuation
frequency of the blade 1308 may exceed 20 kHz (e.g., ultrasonic
range). In either case, it is anticipated that the actuation
frequency of the blade 1308 may be adjusted higher or lower to suit
a cutting application (e.g., index speed, tissue type, operator
preference, and the like).
[0125] In accordance with embodiments of the present disclosure,
the blade 1308, or other cutting surface, may be deployed from
within a shaft of the tissue slitting device 1308. Additionally or
alternatively, any tissue slitting member (e.g., cutting tip,
grinding tips, laser ablation, RF cutting, pressurized fluid
cutters) may be shielded. Accordingly, any sharp or working members
may be concealed from exposure to the patient 102 and/or
vasculature, during navigation to a tissue growth 108 site. This
concealment and/or shielding may act to prevent damage to a patient
102. As can be appreciated, any of the tissue slitting devices
disclosed herein may utilize a deployable and/or shielded slitting
member.
[0126] FIGS. 14A and 14B show a disk-style tissue slitting device
1404 inside an area of vasculature in accordance with embodiments
of the present disclosure. In some embodiments, the tissue slitting
device 1404 comprises an inner lumen 1416, at least one disk-style
cutting blade 1408, a disk-style cutting blade actuation element
1410, a tapered section 1420, and a tapered section transition
1424. The inner lumen 1416 may be configured to allow a lead 104
and/or other objects to pass therethrough (e.g., a lead-locking
device, traction device, snare tool, etc.). As can be appreciated,
the tissue slitting device 1404 may be indexed and/or guided along
the lead 104 via the inner lumen 1416 of the device 1404. As shown,
the disk-style cutting blade 1408 can move in one or more
rotational direction 1418. In some embodiments, the disk-style
cutting blade 1408 may rotate continually in one direction, while
actuated. For example, the actuation element 1410 may be
operatively connected to the disk-style cutting blade 1408 at a
point that is off of the axis of revolution of the blade 1408. By
moving the actuation element 1410 axially in this example the
off-axis motion could engender rotation about a fixed axis of
revolution. Alternatively, the actuation element 1410 may be an
electrical connection to a power source at the proximal end of the
tissue slitting device 1404. In this example, the disk-style
cutting blade 1408 may include a motor at the distal end that is
operatively attached to the blade 1408 and is powered by a power
source connected to the electrical connection.
[0127] In other embodiments, the disk-style cutting blade 1408 may
repeatedly alternate directions of rotation (e.g., from a clockwise
to a counterclockwise direction, and so forth). When the cutting
blade 1408 is engaged with a tissue growth 108, and actuated, the
disk-style cutting blade may cause at least a partial slit in the
engaged tissue growth 108.
[0128] Referring to FIG. 14A, the disk-style cutting blade 1408 may
be oriented such that the cutting surface of the blade 1408 is
maintained substantially parallel with the outer surface of the
lead 104 during cutting and engagement with a tissue growth 108. In
some embodiments, the angle of the disk-style cutting blade 1408
may be arranged such that an obtuse angle is formed between a plane
that is coincident with the lead axis 104 and a non-cutting surface
of the disk-style cutting blade 1408. Orienting the disk-style
cutting blade 1408 at an angle to the tissue growth 108 may assist
in the cutting of at least one slit in the tissue growth 108 formed
around the lead 104.
[0129] FIG. 14B shows the disk-style cutting blade 1408 oriented
such that the cutting surface of the blade 1408 is maintained
substantially perpendicular to the outer surface of the lead 104
during cutting and engagement with a tissue growth 108. In some
embodiments, the disk-style cutting blade 1408 may not be connected
to a power source via the actuation element 1410. In this case, the
cutting blade 1408 may be free to rotate about a fixed axis of
revolution and as such may be presented to the tissue growth 108
and engaged further into the growth 108 to create a slit in the
tissue 108.
[0130] FIGS. 15A and 15B show a deployable cutting element tissue
slitting device 1504 inside an area of vasculature in accordance
with embodiments of the present disclosure. In some embodiments,
the tissue slitting device 1504 comprises an inner lumen 1516, at
least one deployable cutting element 1508, a leading edge 1526, a
tapered section 1520, a tapered section transition 1524, a tissue
tension taper 1522, a cutout 1530, a deployment element 1534
connected to an actuation element 1538, and a cutting element
retaining member 1542. The inner lumen 1516 may be configured to
allow a lead 104 and/or other objects to pass therethrough (e.g., a
lead-locking device, traction device, snare tool, etc.). As can be
appreciated, the tissue slitting device 1504 may be indexed and/or
guided along the lead 104 via the inner lumen 1516 of the device
1504.
[0131] In some embodiments, the tissue slitting device 1504 may
include a section having a concealed blade or deployable cutting
surface. The leading edge 1526 may incorporate a tapered
non-traumatic leading edge disposed at the distal most end of the
tissue slitting device 1504, as previously disclosed. Additionally
or alternatively, one or more features of the tissue slitting
device 1504 may be configured to wedge in between the tissue growth
108 and the lead 104. In some embodiments, the tissue slitting
device 1504 may include a slot, cutout, keyway, opening, or other
volume 1530, housing a cutting surface 1508. In one embodiment the
cutting surface 1508 may be operatively attached to a deployment
element 1534 that is configured to deploy and/or conceal the
cutting surface 1508 upon receiving an input directing an
actuation. As can be appreciated, the deployment element 1534 may
comprise, but is not limited to, one or more of, a balloon, a ramp,
a screw, a wedge, an expansible member, a cam-operated lever, a
lever, a cam, and combinations thereof. For example, the tissue
slitting device 1504 may be oriented into a position, such that the
leading edge 1526 of the tissue slitting device 1504 engages with a
tissue growth 108. Once engaged, an operator may deploy the cutting
surface 1508 of the tissue slitting device 1504 from a concealed
position (see, e.g., FIG. 15A) by actuating the deployment element
1534 via the actuation element 1538. When the cutting surface 1508
is deployed (see, e.g., FIG. 15B), the tissue slitting device 1504
may be indexed further along the lead 104 and into the formed
tissue 108. While the cutting surface 1508 is deployed and indexed
along the lead 104, the formed tissue 108 is slit along a length
adjacent to the cutting surface 1508. This arrangement offers the
additional benefit of navigating the cutting surface 1508 (and any
sharp and/or hardened blade) inside a patient in a safe collapsed,
retracted, concealed, and/or undeployed, state.
[0132] In one example, the cutting element 1508 may be deployed by
actuating a balloon operatively connected to the cutting element
1508. In other words, in this example, the deployment element 1534
may comprise a balloon, while the actuation element 1538 may
comprise a lumen configured to convey a fluid (e.g., gas or liquid)
suitable to inflate the balloon and extend the cutting element
1508. In some embodiments, the cutting element may be retained in
the cutout 1530 via a retaining member 1542. For instance, the
retaining member may include a spring connected to the tissue
slitting device 1504 (e.g., at the cutout 1530) and the cutting
member 1508. Additionally or alternatively, the retaining member
1542 may assist in returning the cutting element 1508 to a
retracted, or concealed, state. In the case of a spring, the
retaining member 1542 may exert a force on the cutting element 1508
to resist deployment without sufficient actuation via the
deployment element 1534.
[0133] In another example, the cutting element 1508 may be deployed
via a cam element operatively connected to the cutting element
1508. The cam element may be actuated via a rotation or other
movement of the actuation element 1538 that is connected to the cam
element. In this case, the retaining member 1542 may include a cam
groove, guide, raceway, combinations thereof, or other combination
of elements to direct and retain the cutting member 1508.
[0134] Grinding Embodiments:
[0135] Referring to FIG. 16, an embodiment of a tissue slitting
device 1604 inside an area of vasculature having formed tissue 108
surrounding an implanted lead 104 in accordance with embodiments of
the present disclosure. In some embodiments, the tissue slitting
device 1604 comprises an inner lumen 1616, at least one
reciprocating grinder 1608, a reciprocating grinder actuation
element 1610, a tapered section 1620, and a tapered section
transition 1624. The inner lumen 1616 may be configured to allow a
lead 104 and/or other objects to pass therethrough (e.g., a
lead-locking device, fraction device, snare tool, etc.). As can be
appreciated, the tissue slitting device 1604 may be indexed and/or
guided along the lead 104 via the inner lumen 1616 of the device
1604. In one embodiment, the reciprocating grinder 1608 may be
configured to move back-and-forth in an axial direction 1618. This
actuation may be independent of the movement of the outer shaft of
the device 1604. The reciprocating motion of the grinder 1608 may
be achieved via a reciprocating actuator that is operatively
connected proximal to the distal tip. The reciprocating actuator
may be an electrical motor that is located at the proximal end of
the flexible shaft. In some embodiments, the reciprocating actuator
may be manually operated via a mechanical movement at the proximal
end of the flexible shaft connected to the tissue slitting device
1604. In any event, energy from the actuator may be transferred to
the grinder 1608 via an actuation element 1610. It is anticipated
that the actuation element 1610 may comprise one or more of a
shaft, rod, bar, link, and the like, that is configured to transmit
force from the proximal end of the tissue slitting device 1604 to
the grinder 1608.
[0136] In one embodiment, the reciprocating blade 1608 may be
configured to move a grinding surface horizontal to the central
axis of the tissue slitting device 1604. In other words, rather
than reciprocating along an axis of the tissue slitting device
1604, as previously disclosed, the reciprocating grinder in this
embodiment may operate across (or side-to-side) the distal tip of
the tissue slitting device 1604. Additionally or alternatively, the
actuation of the grinder 1608, whether axial or side-to-side, may
be provided at a frequency below 20 kHz. In some embodiments, the
actuation frequency of the grinder 1608 may exceed 20 kHz (e.g.,
ultrasonic range). In either case, it is anticipated that the
actuation frequency of the grinder 1608 may be adjusted higher or
lower to suit a cutting application (e.g., index speed, tissue
type, operator preference, and the like).
[0137] In some embodiments, the tissue slitting device 1604 may
include a grinder disposed at the distal tip of the device 1604.
The grinder 1608 may be configured to slit the formed tissue 108 by
subjecting the tissue 108 to a moving abrasive surface. In one
embodiment, the grinder 1608 may include a grinding tip located at
the distal tip of the device 1604. The grinder 1608 may include an
abrasive surface disposed on at least one surface that is caused to
contact formed tissue 108 on a given side of the lead 104. The
grinder 1608 may be engaged with the tissue growth 108 where the
grinder 1608 emaciates the formed tissue 108 until the tissue 108
is slit at the point of contact with the grinder 1608. In any of
the embodiments disclosed herein, the grinding or abrasive surface
may include at least one rough surface, knurl, machined/formed
metal, abrasive surface, diamond deposition, and combinations
thereof and the like.
[0138] Referring to FIG. 17, an embodiment of a tissue slitting
device 1704 inside an area of vasculature having formed tissue 108
surrounding an implanted lead 104 in accordance with embodiments of
the present disclosure. In some embodiments, the tissue slitting
device 1704 comprises an inner lumen 1716, at least one grinding
mechanism 1708 comprising an abrasive element 1728 and at least one
roller 1730, an actuation element 1710, a tapered section 1720, and
a tapered section transition 1724. The inner lumen 1716 may be
configured to allow a lead 104 and/or other objects to pass
therethrough (e.g., a lead-locking device, traction device, snare
tool, etc.). As can be appreciated, the tissue slitting device 1704
may be indexed and/or guided along the lead 104 via the inner lumen
1716 of the device 1704.
[0139] As shown, the grinding mechanism 1708 can move in one or
more rotational direction 1718. In some embodiments, the grinding
mechanism 1708 may rotate continually in one direction, while
actuated. For example, the actuation element 1710 may be
operatively connected to the at least one roller 1730 to turn the
abrasive element 1728. By turning the at least one roller 1730 and
the abrasive element 1728 the grinding mechanism 1708 may emaciate
tissue it engages at the distal tip of the tissue slitting device
1704. Alternatively, the actuation element 1710 may be an
electrical connection to a power source at the proximal end of the
tissue slitting device 1704. In this example, the grinding
mechanism 1708 may include a motor at the distal end that is
operatively attached to the at least one roller 1730 and is powered
by a power source connected to the electrical connection.
[0140] In other embodiments, the at least one roller 1730 may
repeatedly alternate directions of rotation (e.g., from a clockwise
to a counterclockwise direction, and so forth). When the abrasive
element 1728 is engaged with a tissue growth 108, and actuated, the
abrasive element 1728 may cause at least a partial slit in the
engaged tissue growth 108.
[0141] FIG. 18 shows an embodiment of a tissue slitting device 1804
inside an area of vasculature having formed tissue 108 surrounding
an implanted lead 104 in accordance with embodiments of the present
disclosure. In some embodiments, the tissue slitting device 1804
comprises an inner lumen 1816, at least one grinding wheel 1808
comprising at least one abrasive surface 1828, an actuation element
1810, a tapered section 1820, and a tapered section transition
1824. The inner lumen 1816 may be configured to allow a lead 104
and/or other objects to pass therethrough (e.g., a lead-locking
device, traction device, snare tool, etc.). As can be appreciated,
the tissue slitting device 1804 may be indexed and/or guided along
the lead 104 via the inner lumen 1816 of the device 1804.
[0142] As shown, the grinding wheel 1808 can move in one or more
rotational direction 1818. In some embodiments, the grinding wheel
1808 may rotate continually in one direction, while actuated. For
example, the actuation element 1810 may be operatively connected to
the at least wheel 1808 to rotate the wheel 1808 about a fixed
axis. As the grinding wheel 1808 is rotated it can emaciate tissue
it engages at the distal tip of the tissue slitting device 1804.
Alternatively, the actuation element 1810 may be an electrical
connection to a power source at the proximal end of the tissue
slitting device 1804. In this example, the grinding wheel 1808 may
include a motor at the distal end that is operatively attached to
the grinding wheel 1808 and is powered by a power source connected
to the electrical connection.
[0143] In other embodiments, the grinding wheel 1808 may repeatedly
alternate directions of rotation (e.g., from a clockwise to a
counterclockwise direction, and so forth). When the abrasive
surface 1828 is actuated and then engaged with a tissue growth 108,
the grinding wheel 1808 may cause at least a partial slit in the
engaged tissue growth 108 by emaciating contacted tissue growth
108.
[0144] Referring to FIGS. 19A and 19B, an embodiment of an abrasive
tissue slitting device is shown in accordance with embodiments of
the present disclosure. In some embodiments, the tissue slitting
device 1904 comprises an inner lumen 1916, at least one grinding
surface 1908 having an exposed edge 1926 inside a lumen cutout 1930
of the distal tip 1912, a shielded lumen portion 1920, a tapered
transition 1924, and a transmission shaft 1934. The inner lumen
1916 may be configured to allow a lead 104 and/or other objects to
pass therethrough (e.g., a lead-locking device, traction device,
snare tool, etc.). As can be appreciated, the tissue slitting
device 1904 may be indexed and/or guided along the lead 104 via the
inner lumen 1916 of the device 1904.
[0145] In some embodiments, the tissue slitting device 1904
provides a rotating grinding surface 1908 to emaciate tissue growth
108 along one side of the lead 104. In other words, the tissue
slitting device 1904 includes a cutout 1930 to expose a grinding
edge 1926 to the tissue growth 108. It is anticipated that the
grinding surface 1908 may be rotated and/or operate similarly to
the previously disclosed grinding embodiments. In other words, the
grinding surface 1908 may be rotated in one direction continuously
and/or periodically, and/or in alternate directions (e.g.,
clockwise and counterclockwise) continuously and/or
periodically.
[0146] In one embodiment, the grinding surface may be partially
covered by a shielded lumen portion 1920. The shielded lumen
portion 1920 may prevent contact of the grinding surface with areas
of the vasculature, or lead 104, other than a section of the formed
tissue 108 surrounding the lead 104. As can be expected, the
partial covering may present an exposed section of the grinding
surface 1908 to contact the formed tissue that is engaged with the
distal tip of the tissue slitting device 1904. In some embodiments,
the grinding surface 1908 may be angled, or disposed at an angle,
in relation to the distal tip 1912 of the tissue slitting device
1904.
[0147] Laser Ablation Embodiments:
[0148] FIGS. 20-25 show embodiments of a tissue slitting device
utilizing laser ablation and one or more light guides that are
configured to transmit light to ablate the tissue 108 surrounding
at least a portion of the lead 104. It should be noted that the
laser ablation embodiments may be used alone or in combination with
any of the other embodiments set forth in this disclosure. That is,
the laser ablation embodiments may be used in conjunction with the
cutting, grinding, planing, high-pressure solution, and other
embodiments discussed herein.
[0149] FIG. 20 shows an embodiment of a tissue slitting device 2004
inside an area of vasculature having formed tissue 108 surrounding
an implanted lead 104 in accordance with embodiments of the present
disclosure. In some embodiments, the tissue slitting device 2004
comprises an inner lumen 2016, a light-emitting distal end 2008, at
least one light guide 2010, a tapered section 2020, and a tapered
section transition 2024. The inner lumen 2016 may be configured to
allow a lead 104 and/or other objects to pass therethrough (e.g., a
lead-locking device, fraction device, snare tool, etc.). As can be
appreciated, the tissue slitting device 2004 may be indexed and/or
guided along the lead 104 via the inner lumen 2016 of the device
2004.
[0150] The light-emitting distal end 2008 of the tissue slitting
device 2004 may comprise one or more terminated light guides 2010.
In one embodiment, the one or more terminated light guides 2010 may
be optical fibers that can are arranged such that light is directed
along a path 2018 toward a tissue growth 108 surrounding an area of
a lead 104. It is anticipated that the optical fibers can conduct
laser light generated by a laser system located at the proximal end
of the tissue slitting device 2004. In some cases, the laser light
may be generated in the 308 nanometer range. Exemplary laser light
may include pulsed laser light created by an XeCl Excimer laser
system.
[0151] In accordance with one aspect of the present disclosure, the
wavelength of the laser light conducted by the optical fibers,
and/or light guides 2010, as disclosed herein may be adjusted to
match a desired ablation energy for various deposits and/or growths
inside a patient. As can be appreciated, different deposits and/or
growths may require different laser wavelengths for efficient
ablation. These deposits may include tissue, fat, collagen,
elastin, lipid accumulation, fibrotic layers, plaque, calcified
layers, and the like. In one example, the wavelength of the laser
system may be selectively tuned using one or more optical
components to provide a second laser wavelength. In other words,
the one or more optical components may alter a characteristic
associated with the light energy emitted by a laser source.
Examples of such optical components may include, but are not
limited to, one or more filters, lenses, prisms, coatings, films,
and deposited layers of optically transmissive material. In another
example, a second laser system may be optically coupled with the
optical fibers and/or light guides to provide the second laser
wavelength. This second laser system and the corresponding second
wavelength may be activated in conjunction with the laser system.
Alternatively, the second laser system and second laser wavelength
may be activated separately from the laser system.
[0152] It is an aspect of the present disclosure that the
wavelength of the laser light conducted by the optical fibers
and/or light guides may be adjusted during an ablation operation.
As can be appreciated, an operator may select an appropriate
wavelength of laser light as required to ablate various deposits.
This selection may be performed without requiring removal of the
optical fibers and/or light guides from the patient. In other
words, a switch from one laser wavelength to another laser
wavelength can be performed outside of the patient at the laser
system and/or the second laser system.
[0153] In one embodiment, the tissue slitting device 2004 may
include features that contact the lead 104 and allow the
light-emitting distal end 2008 to accept deviations in lead
geometry and location. For instance, the features may include a
spring, band, or other elastic member that is operatively connected
to an area of the light-emitting distal end 2008. In this example,
when the distal end 2008 contacts a change in lead 104 geometry,
the tissue growth 108, or other foreign object, the elastic member
can accommodate the change and adjust a position and/or orientation
of the light-emitting distal end 2008.
[0154] In accordance with embodiments of the present disclosure,
the tissue slitting device 2004 may configured to cause an ablation
of tissue in a given width and/or depth along an axial length of
the lead 104. In some instances, the light-emitting distal end 2008
may be configured to cauterize, ablate, or otherwise separate
tissue growth 108 along a thin section. For instance, the tissue
slitting device 2004 may create an initial separation of tissue as
wide as the array of one or more optical fibers. As can be
appreciated, the width of the initial tissue separation can be
correlated to the arrangement and width of the one or more light
guide 2010 of the tissue slitting device 2004.
[0155] In another embodiment, the one or more light guide 2010 may
direct light at least partially inward toward the central axis of
the lead 104. The one or more light guide 2010 may be disposed to
conduct at least portion of the light angularly toward the distal
end of the tissue slitting device 2004 and/or toward the central
axis of the lead 104. As the tissue slitting device 2004 engages
the tissue growth 108, the laser light may be activated and the
tissue 108 may be severed along the line of conducted light.
[0156] FIG. 21 shows an embodiment of a tissue slitting device 2104
in accordance with embodiments of the present disclosure. In some
embodiments, the tissue slitting device 2104 comprises an inner
lumen 2116, a laser member 2112 comprising a light-emitting distal
end 2108 at least one light guide 2128 and a lead engagement
feature 2132, and a tapered section transition 2124. The inner
lumen 2116 may be configured to allow a lead 104 and/or other
objects to pass therethrough (e.g., a lead-locking device, traction
device, snare tool, etc.). As can be appreciated, the tissue
slitting device 2104 may be indexed and/or guided along the lead
104 via the inner lumen 2116 of the device 2104.
[0157] The laser member 2112 may include one or more features 2132
to engage with an implanted lead 104. One example of such a lead
engagement feature 2132 may include an arcuate surface that is
disposed on the lead 104 side of the laser member 2112. As can be
appreciated, the arcuate surface of the lead engagement feature
2132 may substantially contact the lead 104 at more than one point.
This multiple-point contact may provide stability to the tissue
slitting device 2104 as it is indexed along the lead 104.
[0158] In some cases, a plurality of light guides 2128 may be
arranged vertically. As such, the light guides 2128 may direct
laser light along a plane that runs along, or parallel to, the lead
104 axis. In other words, the tissue slitting device 2104, when
actuated and presented adjacent to a tissue growth 108, may cause a
separation of tissue in a tissue growth 108 along an axial length
of the growth 108.
[0159] FIG. 22 shows an embodiment of a tissue slitting device 2204
in accordance with embodiments of the present disclosure. In some
embodiments, the tissue slitting device 2204 comprises an inner
lumen 2216, a laser member 2212 comprising a light-emitting distal
end 2208 at least one light guide 2228 and a lead engagement
feature 2232, and a tapered section transition 2224. The inner
lumen 2216 may be configured to allow a lead 104 and/or other
objects to pass therethrough (e.g., a lead-locking device, traction
device, snare tool, etc.). As can be appreciated, the tissue
slitting device 2204 may be indexed and/or guided along the lead
104 via the inner lumen 2216 of the device 2204.
[0160] The laser member 2212 may include one or more features 2232
to engage with an implanted lead 104. One example of such a lead
engagement feature 2232 may include an arcuate surface that is
disposed on the lead 104 side of the laser member 2212. As can be
appreciated, the arcuate surface of the lead engagement feature
2232 may substantially contact the lead 104 at more than one point.
This multiple-point contact may provide stability to the tissue
slitting device 2204 as it is indexed along the lead 104.
[0161] In some cases, a plurality of light guides 2228 may be
arranged horizontally. As such, the light guides 2228 may direct
laser light along a plane that runs along, or parallel to, the
outer circumference of the lead 104. In other words, the tissue
slitting device 2204, when actuated and presented adjacent to a
tissue growth 108, may cause a separation of tissue in a tissue
growth 108 along an axial length and width of the growth 108. This
separation of tissue is similar to the removal of tissue provided
by the embodiment disclosed in FIG. 11.
[0162] FIG. 23 shows a distal end view of a laser tissue slitting
device 2304 in accordance with embodiments of the present
disclosure. In some embodiments, the tissue slitting device 2304
comprises a shaft 2324, an inner lumen 2316, and a plurality of
optical fibers 2328. illustrates a tube having a distal end with
optical fibers included therein. The inner lumen 2316 may be
configured to allow a lead 104 and/or other objects to pass
therethrough (e.g., a lead-locking device, fraction device, snare
tool, etc.). As can be appreciated, the tissue slitting device 2304
may be indexed and/or guided along the lead 104 via the inner lumen
2316 of the device 2304. The optical fibers 2328 may be used to
ablate a section of tissue growth 108 surrounding a lead 104.
Additionally or alternatively, the optical fibers 2328 may be
disposed in a portion of the shaft 2324 or about the entire
periphery of the shaft 2324.
[0163] FIGS. 24-25 show embodiments where one or more laser
ablation features are combined with other tissue slitting
embodiments as disclosed or suggested herein.
[0164] Referring to FIG. 24, a distal end view of a tissue slitting
device 2404 is shown in accordance with embodiments of the present
disclosure. In some embodiments, the tissue slitting device 2404
comprises a shaft 2424, an inner lumen 2416, at least one wedge
feature 2420, and a plurality of optical fibers 2428. Additionally
or alternatively, the tissue slitting device 2404 may include a
cutting edge 2408. The inner lumen 2416 may be configured to allow
a lead 104 and/or other objects to pass therethrough (e.g., a
lead-locking device, traction device, snare tool, etc.). As can be
appreciated, the tissue slitting device 2404 may be indexed and/or
guided along the lead 104 via the inner lumen 2416 of the device
2404. The optical fibers 2428 may be used to ablate a section of
tissue growth 108 surrounding a lead 104. The optical fibers 2428
may be disposed in a portion of the shaft 2424 or about the entire
periphery of the shaft 2424. In some embodiments, when the optical
fibers 2428 are included in only a portion of the shaft 2424, it
may be preferable to bias the optical fibers 2428 adjacent to the
cutting edge 2408 or cutting tip of the shaft 2424 as shown.
Alternatively, it may be preferable to include the optical fibers
2428 at a distance away from the cutting edge 2408 or cutting tip
of the shaft 2424. In some embodiments, it may be preferable to
include as many optical fibers 2428 as possible within the
circumference of the shaft 2424.
[0165] FIG. 25 shows a distal end view of a tissue slitting device
2504 in accordance with embodiments of the present disclosure. In
some embodiments, the tissue slitting device 2504 comprises a shaft
2524, an inner lumen 2516, at least one cutting wedge feature 2520,
and a plurality of optical fibers 2528. Additionally or
alternatively, the tissue slitting device 2504 may include a distal
cutting edge 2508. The inner lumen 2516 may be configured to allow
a lead 104 and/or other objects to pass therethrough (e.g., a
lead-locking device, traction device, snare tool, etc.). As can be
appreciated, the tissue slitting device 2504 may be indexed and/or
guided along the lead 104 via the inner lumen 2516 of the device
2504. The optical fibers 2528 may be used to ablate a section of
tissue growth 108 surrounding a lead 104. The optical fibers 2528
may be disposed in a portion of the shaft 2524 or about the entire
periphery of the shaft 2524. In some embodiments, when the optical
fibers 2528 are included in only a portion of the shaft 2524, it
may be preferable to bias the optical fibers 2528 adjacent to the
distal cutting edge 2508 or cutting tip of the shaft 2524 as shown.
Alternatively, it may be preferable to include the optical fibers
2528 at a distance away from the cutting edge 2508 or cutting tip
of the shaft 2524. In some embodiments, it may be preferable to
include as many optical fibers 2528 as possible within the
circumference of the shaft 2524.
[0166] Additionally or alternatively, the tissue slitting edge may
utilize other wavelengths of emitted radiation energy, such as
thermal or infrared energy, electromagnetic radiation, and/or other
radiation wavelengths to slit or cut the formed tissue. The tissue
slitting edge can, for example, be an energy device, such as a
power sheath (of a catheter), which typically applies a form of
energy at the sheath tip to cut the scar tissue away from the lead
thus allowing for removal. As the sheath is pushed over the lead
and comes to an area of attachment, the operator can turn on the
sheath's energy source to heat or vaporize scar tissue, forming the
desired slit. One such sheath uses electrocautery, similar to what
is used to cut through tissue in surgery. Another sheath has one or
more tiny energy emitters at its tip or edge. When activated, the
emitted energy vaporizes water molecules in scar tissue within
about 1 mm, thereby forming the desired slit or cut. Additionally
or alternatively, dilating telescopic sheaths or cutting balloons
of a catheter having a longitudinally positioned tissue slitting
edge can be fully or partially expanded or inflated, thereby
deploying the tissue slitting edge to form the desired slit.
[0167] In some embodiments, the distal tip of the tissue slitting
device 2504 may include a wedge cutting feature 2520. The wedge
cutting feature 2520 may comprise a blade and a wedge configured to
peel the tissue away from the cutting edge 2508 of the tissue
slitting device 2504 as it is being cut by the cutting edge 2508
and the blade. Utilizing a combination of laser ablation
embodiments with other tissue slitting embodiments allows for
creative solutions to various tissue growths 108. For example, the
laser light in a laser tissue slitting device 2504 may be actuated
in pulses to ablate sections of difficult tissue growth 108 while
the wedge cutting feature 2520 acts to cut and separate ablated and
other areas of the tissue growth 108. As can be appreciated,
various laser embodiments and/or actuation techniques and other
tissue slitting features may be combined to best suit individual
tissue growth 108 in a patient 102.
[0168] It should be noted that the laser ablation embodiments, as
well as the other embodiments disclosed herein, may be used alone
or in combination with the non-traumatic leading edge, wedges,
tapers, and/or other tissue slitting embodiments disclosed without
limitation. Additionally or alternatively, the tissue slitting
devices disclosed herein may include at least one fluorescing
material or marker (e.g., radiopaque band, marker, and the like).
In some embodiments, the radiopaque marker may be arranged about
and/or adjacent to a tissue cutting area (e.g., laser optical
fibers, blades, planers, electromagnetic radiation emitter, RF
devices, high-pressure fluid, grinders, sanders, drills, ultrasonic
devices, and the like) of the tissue slitting device. The
radiopaque marker, may assist in identifying a location of the
tissue cutting area via a monitoring device. Examples of radiopaque
markers may include, but are in no way limited to, materials and/or
particles containing tantalum, tungsten, carbide, iridium, bismuth
oxide, barium sulfate, cobalt, platinum and/or alloys and
combinations thereof.
[0169] High-Pressure Solution Embodiments:
[0170] FIG. 26 shows a tissue slitting device 2604 inside an area
of vasculature having tissue growth 108 surrounding an implanted
lead 104 in accordance with embodiments of the present disclosure.
In some embodiments, the tissue slitting device 2604 comprises a
shaft 2606, an inner lumen 2616, at least one fluid channel 2610,
at least one nozzle 2608, a tissue-side taper 2620, and an
opening-side taper 2608. Additionally or alternatively, the tissue
slitting device 2604 may include a port opening 2630. The inner
lumen 2616 may be configured to allow a lead 104 and/or other
objects to pass therethrough (e.g., a lead-locking device, traction
device, snare tool, etc.). As can be appreciated, the tissue
slitting device 2604 may be indexed and/or guided along the lead
104 via the inner lumen 2616 of the device 2604. Embodiments of the
present disclosure anticipate using a solution (e.g., NaCl, MgCl,
saline, etc.) directed under pressure to remove formed tissue 108
attached to an implanted lead 104. A fluid channel 2610 having a
proximal end, a distal end, and an inner lumen running from the
proximal end of the fluid channel 2610 to an area of the distal end
of the tissue slitting device 2604, may be disposed substantially
parallel to the shaft 2606 to contain the pressurized solution
(e.g., NaCl, saline, etc.).
[0171] In some embodiments, the channel 2610 may taper in the form
of a nozzle 2608 at the distal end to focus fluid expelled from the
channel 2610. As can be appreciated, the focus of the fluid out of
the nozzle 2608 increases the pressure of the fluid that contacts a
tissue growth 108. Alternatively, a fluid channel 2610 may include
a port opening 2630 that does not include any taper. As such, the
fluid is not focused as it is expelled from the fluid port opening
2630. In some embodiments, the channel 2610 may include a plurality
of orifices configured to expel saline solution. This plurality of
orifices may include one or more nozzle 2608 features to control
the rate of flow of the saline solution. Additionally or
alternatively, the at least one orifice may be directed toward the
lead 104, formed tissue 108, or other object and/or obstruction. In
one embodiment, a first orifice may be oriented at a first angle to
the lead 104 and/or formed tissue 108, and a second orifice may be
oriented at a second angle to the lead 104 and/or formed tissue
108. In another embodiment, the angle and/or shape of the nozzle
2608, opening 2630, or orifices may be affected by the angle of the
tissue-side taper 2620 and/or the opening-side taper 2608. Among
other things, the orifices may be used to clear obstructions, clean
the lead 104 as the tissue slitting device 2604 is moved along the
lead 104, and/or provide lubrication for the inner lumen 2616 of
tissue slitting device 2604 as it is moved along a lead 104.
[0172] Additionally or alternatively, solution may be forced
between the tissue growth 108 and the lead 104 via at least one
channel 2610 associated with the tissue slitting device 2604. The
forced solution may act to expand and/or dilate the tissue growth
108 formed around a lead 104 or object. In some embodiments, the
dilation of the formed tissue 108 created by the solution may
create an opening for insertion of the distal end of the tissue
slitting device 2604.
[0173] As can be appreciated, use of the forced solution may be
combined with any other device and/or method disclosed herein. In
one embodiment, the forced solution may cause the formed tissue 108
to expand around the lead 104 such that the formed tissue 108 no
longer applies any forces to the lead 104. In such cases, the lead
104 may be removed from the formed tissue 108 while it is
dilated.
[0174] Referring to FIG. 27, a tissue slitting method 2700 will be
described in accordance with at least some embodiments of the
present disclosure. The method 2700 starts at 2704 and begins by
connecting a lead-locking device or other traction device to the
lead 104 (step 2708). In some embodiments, the lead-locking device
may be inserted into the core of an implanted lead 104. In other
embodiments, a traction device may be connected to the lead 104 to
provide traction on the lead 104. For instance, mechanical traction
can be achieved in leads 104 by inserting a locking stylet into the
lead 104 and applying a pull force onto the lead 104 via the
locking stylet.
[0175] Once a traction device is attached to the lead 104, the
traction device can be threaded through the internal, or inner,
lumen of the tissue slitting device (step 2712). For example, the
lead-locking device may be inserted through the lumen in an
implanted lead 104 and attached to the internal portions of the
implanted lead 104, which can be at the distal portion or proximal
to the distal portion of the lead 104. The tissue slitting device
may be part of a catheter that rides over the external portion of
the lead 104 and lead-locking device and is configured to remove
tissue along an axial length of the tissue 108 in contact with the
lead 104.
[0176] As the tissue slitting device is engaged with the lead 104,
a slight traction force may be applied to the lead 104 to allow the
tissue slitting device to guide along the lead 104 (step 2716). The
tissue slitting device can be moved toward the first formed tissue
growth while applying a mechanical traction force to the lead 104
itself or through a locking stylet, or other traction device.
Mechanical traction force should be applied with appropriate force
to prevent tearing the vein or artery wall by moving the lead 104
and tissue before they are separated. In some embodiments, the
tissue slitting device may be observed moving inside a patient 102
via a fluoroscope or other monitor. It is anticipated that the
distal tip, or some other area, of the tissue slitting device may
include a fluorescing material or marker (e.g., radiopaque band,
and the like). This fluorescing material or marker may be used to
aid in monitoring the movement of the tissue slitting device when
it is inside a patient.
[0177] Next, the tissue slitter is moved into contact with the
formed tissue growth (step 2720). In some embodiments, the slitting
portion of the tissue slitting device may be oriented toward the
center of the vein, or away from the vein wall connecting the lead
104 to the vein. In addition to preventing accidental puncture,
trauma, or other damage to the delicate surfaces of the vasculature
this orientation of the tissue slitting device may aid in the
slitting and peeling away of the tissue 108 from the implanted lead
104. For example, a tissue slitting device may include a distal tip
with a wedge and/or tapered portion proximal to the sharp portion
of the tissue slitting device. It is anticipated that the distal
tip of the tissue slitting device may include a non-traumatic
leading edge. In some cases, the non-traumatic leading edge and the
tapered portion may comprise the distal tip of the tissue slitting
device. While applying mechanical traction force, the leading
portion (of the tissue slitting device) may include a sharp,
cutting, ablating, or grinding portion, which may be configured to
cut into the tissue growth 108. As the tissue slitting device
traverses along the lead 104, the cutting portion of the tissue
slitting device continues to separate the formed tissue 108.
Additionally the leading portion, which may include a wedge and/or
tapered portion, can act to cause a stretching of the formed tissue
growth 108 at the point where it engages with the tissue slitting
device. This stretching of tissue may assist in the slitting
operation by causing tension on the fibers of the tissue growth 108
that, when slit, pull back (or away) from the tissue slitting
device engagement area.
[0178] Once the tissue slitting device is engaged with, and/or
slitting, the formed tissue, the tissue slitting device may be
actuated and moved along the lead to further engage with the tissue
growth 108 (step 2724). In some embodiments, the tissue slitting
device may be indexed forward (into the tissue formation 108)
continuously or periodically. In other embodiments, the tissue
slitting device may be repeatedly indexed into and removed from the
engagement area of the formed tissue growth 108. It is anticipated
that each time the tissue slitting device is indexed into the
engagement area the device can make a successively longer slit in
the formed tissue 108.
[0179] The method 2700 may be continued by determining whether
other tissue growths exist, and if so, indexing the tissue slitting
device through each formed tissue growth 108 that is surrounding a
section of the implanted lead 104 in the vasculature (step
2728).
[0180] Once all of the formed tissue growths 108 are slit, the
tissue slitting device may be removed from the patient 102 (step
2732). Additionally, or alternatively, once the slits have been
made the lead 104 may be removed by applying a pull force to the
lead-locking device in the same direction as the mechanical
traction force previously applied to the lead 104. It is
anticipated that any movement of the tissue slitting device may be
accompanied by an applied mechanical traction force to the
lead/lead-locking device. The method 2700 ends at step 2736.
[0181] Other Embodiments
[0182] Referring to FIG. 28, an embodiment of an abrasive tissue
slitting device is shown in accordance with embodiments of the
present disclosure. In some embodiments, the tissue slitting device
2804 comprises an inner lumen 2816, at least one grinding surface
2808 having an exposed portion 2826 at least partially surrounded
by a distal tip shield 2820, a tapered transition 2824, and a
transmission shaft 2834. The inner lumen 2816 may be configured to
allow a lead 104 and/or other objects to pass therethrough (e.g., a
lead-locking device, traction device, snare tool, etc.). As can be
appreciated, the tissue slitting device 2804 may be indexed and/or
guided along the lead 104 via the inner lumen 2816 of the device
2804.
[0183] In some embodiments, the tissue slitting device 2804
provides one or more rotating grinding surface 2808 to emaciate
tissue growth 108 along at least one side of the lead 104. In other
words, the tissue slitting device 2804 includes at least one
opening 2830 to expose a grinding edge 2826 to the tissue growth
108. It is anticipated that the grinding surface 2808 may be
rotated and/or operate similarly to the previously disclosed
grinding embodiments. In other words, the grinding surface 2808 may
be rotated in one direction continuously and/or periodically,
and/or in alternate directions (e.g., clockwise and
counterclockwise) continuously and/or periodically. As can be
appreciated, the tissue slitting device 2804 may include one or
more grinding surfaces 2808 that can be linked and/or geared
together. For example, in instances where the tissue slitting
device 2804 includes two or more grinding surfaces 2808, the two or
more grinding surfaces may be geared to operate simultaneously.
Additionally, the grinding surfaces may be directly geared and/or
indirectly geared to rotate/move in alternate and/or similar
rotational directions, respectively.
[0184] In one embodiment, the grinding surface 2808 may be
partially covered by a shielded portion 2820. The shielded portion
2820 may prevent contact of the grinding surface with areas of the
vasculature, or lead 104, other than a section of the formed tissue
108 surrounding the lead 104. As can be expected, the partial
covering may present an exposed section of the grinding surface
2808 to contact the formed tissue that is engaged with the distal
tip of the tissue slitting device 2804. In some embodiments, the
grinding surface 2808 may be angled, or disposed at an angle, in
relation to the distal tip of the tissue slitting device 2804.
[0185] In the appended figures, similar components and/or features
may have the same reference label. Further, various components of
the same type may be distinguished by following the reference label
by a letter that distinguishes among the similar components. If
only the first reference label is used in the specification, the
description is applicable to any one of the similar components
having the same first reference label irrespective of the second
reference label.
[0186] Presented herein are embodiments of a tissue separating
device, system, and method. As described herein, the device(s) may
be electrical, mechanical, electro-mechanical, and/or combinations
thereof.
[0187] Also, while the flowcharts have been discussed and
illustrated in relation to a particular sequence of events, it
should be appreciated that changes, additions, and omissions to
this sequence can occur without materially affecting the operation
of the disclosed embodiments, configuration, and aspects.
[0188] A number of variations and modifications of the disclosure
can be used. It would be possible to provide for some features of
the disclosure without providing others. By way of illustration,
any methodology or modality of cutting tissue may be employed as
described herein to effect lead removal from an encased tissue
growth.
[0189] The present disclosure, in various aspects, embodiments,
and/or configurations, includes components, methods, processes,
systems and/or apparatus substantially as depicted and described
herein, including various aspects, embodiments, configurations
embodiments, subcombinations, and/or subsets thereof. Those of
skill in the art will understand how to make and use the disclosed
aspects, embodiments, and/or configurations after understanding the
present disclosure. The present disclosure, in various aspects,
embodiments, and/or configurations, includes providing devices and
processes in the absence of items not depicted and/or described
herein or in various aspects, embodiments, and/or configurations
hereof, including in the absence of such items as may have been
used in previous devices or processes, e.g., for improving
performance, achieving ease and/or reducing cost of
implementation.
[0190] The foregoing discussion has been presented for purposes of
illustration and description. The foregoing is not intended to
limit the disclosure to the form or forms disclosed herein. In the
foregoing Summary for example, various features of the disclosure
are grouped together in one or more aspects, embodiments, and/or
configurations for the purpose of streamlining the disclosure. The
features of the aspects, embodiments, and/or configurations of the
disclosure may be combined in alternate aspects, embodiments,
and/or configurations other than those discussed above. This method
of disclosure is not to be interpreted as reflecting an intention
that the claims require more features than are expressly recited in
each claim. Rather, as the following claims reflect, inventive
aspects lie in less than all features of a single foregoing
disclosed aspect, embodiment, and/or configuration. Thus, the
following claims are hereby incorporated into this Summary, with
each claim standing on its own as a separate preferred embodiment
of the disclosure.
[0191] Moreover, though the description has included description of
one or more aspects, embodiments, and/or configurations and certain
variations and modifications, other variations, combinations, and
modifications are within the scope of the disclosure, e.g., as may
be within the skill and knowledge of those in the art, after
understanding the present disclosure. It is intended to obtain
rights which include alternative aspects, embodiments, and/or
configurations to the extent permitted, including alternate,
interchangeable and/or equivalent structures, functions, ranges or
steps to those claimed, whether or not such alternate,
interchangeable and/or equivalent structures, functions, ranges or
steps are disclosed herein, and without intending to publicly
dedicate any patentable subject matter.
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