U.S. patent application number 16/747830 was filed with the patent office on 2020-07-09 for denervation methods.
The applicant listed for this patent is Relievant Medsystems, Inc.. Invention is credited to John S. Crombie, Paula Papineau, Samit Patel, Richard C. Pellegrino, Thomas Ryan.
Application Number | 20200214762 16/747830 |
Document ID | / |
Family ID | 42337523 |
Filed Date | 2020-07-09 |
View All Diagrams
United States Patent
Application |
20200214762 |
Kind Code |
A1 |
Pellegrino; Richard C. ; et
al. |
July 9, 2020 |
DENERVATION METHODS
Abstract
System and methods for channeling a path into bone include a
trocar having a proximal end, distal end and a central channel
disposed along a central axis of the trocar. The trocar includes a
radial opening at or near the distal end of the trocar. The system
includes a curveable cannula sized to be received in the central
channel, the curveable cannula comprising a curveable distal end
configured to be extended laterally outward from the radial opening
in a curved path extending away from the trocar. The curveable
cannula has a central passageway having a diameter configured allow
a probe to be delivered through the central passageway to a
location beyond the curved path.
Inventors: |
Pellegrino; Richard C.;
(Leesburg, VA) ; Papineau; Paula; (West
Bridgewater, MA) ; Crombie; John S.; (East Hanover,
NJ) ; Patel; Samit; (Palo Alto, CA) ; Ryan;
Thomas; (Austin, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Relievant Medsystems, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
42337523 |
Appl. No.: |
16/747830 |
Filed: |
January 21, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14701908 |
May 1, 2015 |
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16747830 |
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14136763 |
Dec 20, 2013 |
9023038 |
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14701908 |
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12683555 |
Jan 7, 2010 |
8613744 |
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14136763 |
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12566895 |
Sep 25, 2009 |
8419730 |
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12683555 |
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11123766 |
May 6, 2005 |
7749218 |
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12683555 |
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10260879 |
Sep 30, 2002 |
6907884 |
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11123766 |
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61100533 |
Sep 26, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 18/18 20130101;
A61B 2018/00577 20130101; A61B 2017/00331 20130101; A61B 18/1487
20130101; A61B 17/1671 20130101; A61B 18/1206 20130101; A61B
2018/126 20130101; A61B 18/16 20130101; A61B 2017/3405 20130101;
A61B 17/1642 20130101; A61B 18/02 20130101; A61B 2018/00339
20130101; A61B 17/3472 20130101; A61B 17/3403 20130101; A61B
17/3421 20130101; A61B 18/148 20130101; A61B 2018/00017 20130101;
A61B 17/8805 20130101; A61B 2018/0044 20130101; A61B 2018/1475
20130101; A61B 17/3468 20130101; A61B 2018/00565 20130101; A61F
7/007 20130101; A61N 1/0551 20130101; A61B 2017/3454 20130101; A61B
18/1492 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61B 18/12 20060101 A61B018/12; A61B 17/34 20060101
A61B017/34; A61F 7/00 20060101 A61F007/00; A61B 17/16 20060101
A61B017/16 |
Claims
1. (canceled)
2. A method of treating a vertebral body associated with back pain
in a subject, the method comprising: identifying a target treatment
zone within an inner cancellous bone region of a vertebral body;
transpedicularly inserting a trocar through an outer cortical bone
region of the vertebral body and into the inner cancellous bone
region of the vertebral body; inserting a bipolar radiofrequency
probe through the trocar to the target treatment zone; positioning
at least one electrode of the bipolar radiofrequency probe at a
location that is radially offset from a longitudinal axis of the
trocar; and causing the bipolar radiofrequency probe to generate
heat within the target treatment zone sufficient to treat an
intraosseous nerve within the target treatment zone.
3. The method of claim 2, wherein the heat generated is sufficient
to denervate the intraosseous nerve.
4. The method of claim 2, wherein the heat generated is sufficient
to ablate the intraosseous nerve.
5. The method of claim 2, wherein the heat generated is sufficient
to necrose the intraosseous nerve.
6. The method of claim 2, wherein the bipolar radiofrequency probe
is flexible.
7. The method of claim 2, wherein the step of positioning the at
least one electrode comprises advancing the bipolar radiofrequency
probe along a curved path
8. The method of claim 2, further comprising penetrating a skin of
the subject.
9. The method of claim 2, wherein the intraosseous nerve is a
basivertebral nerve.
10. A method of therapeutically treating a vertebral body having an
outer cortical bone region and an inner cancellous bone region, and
a basivertebral nerve (BVN) having a trunk extending from the outer
cortical bone region into the inner cancellous region and branches
extending from the trunk to define a BVN junction, the method
comprising: a) inserting an energy device into the vertebral body,
and b) exclusively depositing energy within the inner cancellous
bone region of the vertebral body between, but exclusive of the BVN
junction and the outer cortical bone region, to denervate the
BVN.
11. The method of claim 10, wherein the energy device comprises two
electrodes.
12. The method of claim 11, further comprising placing the two
electrodes in a posterior region of the vertebral body.
13. The method of claim 11, further comprising placing the two
electrodes in a region of the vertebral body located between 60%
and 90% of the distance between the anterior and posterior ends of
the vertebral body.
14. A system for therapeutically heating a vertebral body to treat
back pain, comprising: a cannula configured to be inserted through
the outer cortical bone region of the vertebral body and into the
inner cancellous bone region of the vertebral body; a flexible
energy delivery probe having two electrodes that is sized and
configured to be inserted within a central passageway of the
cannula, and an energy delivery source coupled to the two
electrodes, wherein said two electrodes are configured to deliver
thermal energy to an intraosseous nerve within the vertebral body
sufficient treat the intraosseous nerve.
15. The system of claim 14, wherein said energy device comprises a
bipolar radiofrequency device and the two electrodes comprise an
active electrode and a return electrode.
16. The system of claim 14, wherein the thermal energy is
sufficient to ablate the intraosseous nerve.
17. The system of claim 14, wherein the thermal energy is
sufficient to denervate the intraosseous nerve.
18. The system of claim 14, wherein the thermal energy is
sufficient to necrose the intraosseous nerve.
19. The system of claim 14, wherein the intraosseous nerve is a
basivertebral nerve.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/701,908, filed on May 1, 2015, which is a
continuation of U.S. patent application Ser. No. 14/136,763, filed
on Dec. 20, 2013, now U.S. Pat. No. 9,023,038, which is a
continuation of U.S. patent application Ser. No. 12/683,555, filed
on Jan. 7, 2010, now U.S. Pat. No. 8,613,744, which is a
continuation-in-part of U.S. patent application Ser. No.
12/566,895, filed on Sep. 25, 2009, now U.S. Pat. No. 8,419,730,
which claims priority from U.S. Provisional Application No.
61/100,553, filed on Sep. 26, 2008, the content of each of which is
incorporated herein by reference in its entirety. U.S. patent
application Ser. No. 12/683,555 is also a continuation-in-part of
U.S. patent application Ser. No. 11/123,766, filed on May 6, 2005,
now U.S. Pat. No. 7,749,218, which is a divisional of U.S. patent
application Ser. No. 10/260,879, filed on Sep. 30, 2002, now U.S.
Pat. No. 6,907,884, the content of each of which is incorporated
herein by reference in its entirety.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable
INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT
DISC
[0003] Not Applicable
NOTICE OF MATERIAL SUBJECT TO COPYRIGHT PROTECTION
[0004] A portion of the material in this patent document is subject
to copyright protection under the copyright laws of the United
States and of other countries. The owner of the copyright rights
has no objection to the facsimile reproduction by anyone of the
patent document or the patent disclosure, as it appears in the
United States Patent and Trademark Office publicly available file
or records, but otherwise reserves all copyright rights whatsoever.
The copyright owner does not hereby waive any of its rights to have
this patent document maintained in secrecy, including without
limitation its rights pursuant to 37 C.F.R. .sctn. 1.14.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0005] This invention pertains generally to generating passageways
through tissue, and more particularly to creating curved paths in
bone.
2. Description of Related Art
[0006] Recently, the technique of accessing the vertebral body
through minimally invasive means has been developed through the
surgical techniques used in vertebroplasty and kyphoplasty.
Although accessing the vertebral segments of the spine through the
pedicle and into the lateral/anterior section of the body of the
vertebra is the primary method of placing a treatment device (e.g.
a bone cement delivery device and/or an RF probe) into the
vertebra, it is difficult to place a probe in the posterior midline
section of the vertebra. Furthermore, accessing the posterior
midline section of the S1 segment of the spine is difficult with a
straight linear access route. A probe preferably needs to be
capable of navigating to the posterior section of the Si vertebral
body as well as the same target area within a lumbar vertebral
segment. In addition, it is contemplated that spinal segments in
the cervical and thoracic spine may also be targeted.
[0007] In order to accurately and predictably place a treatment
device in the posterior midline section of a lumbar vertebral body
or Si vertebral body, the device or probe needs to navigate to said
area through varying densities of bone. However due to the varying
densities of bone, it is difficult to navigate a probe in bone and
ensure its positioning will be in the posterior midline section of
the vertebral body.
[0008] Current techniques for tissue aspirations require a coaxial
needle system that allows taking several aspirates through a guide
needle without repositioning the guide needle. However the problem
with this system is that after the first pass of the inner needle
in to the lesion, subsequent passes tend of follow the same path
within the mass, yielding only blood not diagnostic cells.
[0009] A scientific paper written by Kopecky et al., entitled
"Side-Exiting Coaxial Needle for Aspiration Biopsy," describes the
use of a side exiting coaxial needle to allow for several
aspiration biopsies. The guide needle has a side hole 1 cm from the
distal tip. When a smaller needle is advanced through this new
guide needle, the smaller needle is deflected by a ramp inside the
guide, causing the smaller needle to exit through the side hole.
Although this side exiting needle is able to deflect a bone
aspiration needle, it does not guarantee that the needle exits the
side hole in a linear direction into the tissue site. Once the
tissue aspiration needle exits the needle, it will deviate from a
linear path depending on the density of the tissue and inherent
material strength of the needle. This is an inherent problem the
device is unable to overcome.
[0010] Accordingly, an object of the present invention is a system
and method for generating a path in bone that predictably follows a
predetermined curved path.
BRIEF SUMMARY OF THE INVENTION
[0011] The present invention is directed to systems and methods to
deploy and navigate a flexible treatment instrument, such as an RF
bipolar probe, within bone. Although the systems and methods
described below are primarily directed to navigating bone through a
vertebral member of the spine, and particularly to treat the BVN of
a vertebral member, it is appreciated that the novel aspects of the
present invention may be applied to any tissue segment of the
body.
[0012] The first novel principle of this invention is the ability
to navigate a curve or angle within varying densities of cancellous
bone and create a straight channel at the end of the navigated
curve or angle. Several systems are described.
[0013] One aspect is a method of therapeutically treating a
vertebral body having an outer cortical bone region and an inner
cancellous bone region, and a BVN having a trunk extending from the
outer cortical bone region into the inner cancellous region and a
branches extending from the trunk to define a BVN junction,
comprising the steps of: a) inserting an energy device into the
vertebral body, and b) exclusively depositing energy within the
inner cancellous bone region of the vertebral body between, but
exclusive of the BVN junction and the outer cortical bone region,
to denervate the BVN.
[0014] In another aspect of the present invention, a
tube-within-tube embodiment has a deployable curved Nitinol tube
that deploys from a straight cannula. The Nitinol tube is
pre-curved to create an angular range of approximately 0.degree. to
approximately 180.degree., but more specifically from approximately
45.degree. to approximately 110.degree., when fully deployed from
the straight cannula. The design of the curve is such that the
flexible element (carrying the treatment device) can navigate
through the angular range of deployment of the nitinol tube. The
curved nitinol tube allows the flexible element to navigate through
a curve within bone without veering off towards an unintended
direction. Cancellous bone density varies from person to person.
Therefore, creating a curved channel within varying density
cancellous bone will generally not predictably or accurately
support and contain the treatment device as it tries to navigate
the curved channel. With the present invention, the flexible
element is deployed into the bone through the curved Nitinol tube,
which supports the element as it traverses through the curve. When
it departs from the tube, it will do so in a linear direction
towards the target zone. This design allows the user to predictably
and accurately deploy the flexible element towards the target zone
regardless of the density of the cancellous bone.
[0015] An aspect of the invention is a system for channeling a path
into bone. The system comprises a trocar having a central channel
and opening at its distal tip, and a cannula sized to be received
in said central channel and delivered to the distal opening. The
cannula has a deflectable tip with a preformed curve such that the
tip straightens while being delivered through the trocar and
regains its preformed curve upon exiting and extending past the
distal opening of the trocar to generate a curved path in the bone
corresponding to the preformed curve of the deflectable tip. The
cannula comprises a central passageway having a diameter configured
allow a treatment device to be delivered through the central
passageway to a location beyond the curved path.
[0016] In one embodiment, the system further includes a straight
stylet configured to be installed in the trocar, wherein the
straight stylet comprises a sharp distal tip that is configured to
extend beyond the distal opening of the trocar to pierce the bone
as the trocar is being delivered to a treatment location within the
bone.
[0017] The system may further include a straightening stylet
configured to be installed in the cannula, wherein the
straightening stylet comprising a rigid construction configured to
straighten the distal tip of the cannula when positioned in the
trocar.
[0018] In an alternative embodiment, the straightening stylet
further comprises a sharp distal end to pierce the bone, and the
straightening stylet and cannula are installed in the trocar in
place of the straight stylet as the trocar is delivered into the
bone.
[0019] In a preferred embodiment, the system further includes a
curved stylet having an outer radius sized to fit within the
central passageway of the curved cannula. The curved stylet is
configured to be installed in the curved cannula while the curved
cannula is extended past the distal opening of the trocar, the
curved stylet configured to block the distal opening of the curved
cannula while being delivered into the bone. Preferably, the curved
stylet has a curved distal end corresponding to the curve of the
curved cannula.
[0020] The curved stylet also has a sharp distal tip configured to
extend past the curved cannula to pierce the bone as the cannula is
delivered past the distal opening of the trocar. The curved stylet
also preferably comprises an angled distal tip configured to
further support and maintain the curved stylet radius as it is
delivered past the distal opening of the trocar and into bone.
[0021] Preferably, the curved stylet and the curved cannula have
mating proximal ends that align the curve of the curved stylet with
the curve of the curved cannula.
[0022] In one embodiment, the system further includes a straight
channeling stylet configured to be installed in the cannula after
removing the curved stylet, wherein the straight channeling stylet
is flexibly deformable to navigate the curved cannula yet retain a
straight form upon exiting the curve cannula, and wherein straight
channeling stylet has a length longer than the curved cannula such
that it creates a linear path beyond the distal end of the curved
cannula when fully extended.
[0023] Another aspect is method for channeling a path into bone to
a treatment location in the body of a patient. The method includes
the steps of inserting a trocar having a central channel and
opening at its distal tip into a region of bone at or near the
treatment location, and delivering a cannula through said central
channel and to said distal opening, wherein the cannula comprises a
deflectable tip with a preformed curve such that the tip
straightens while being delivered through the trocar and regains
its preformed curve upon exiting the trocar, and extending the
cannula past the distal opening of the trocar to generate a curved
path in the bone corresponding to the preformed curve of the
deflectable tip. Finally, a treatment device is delivered through a
central passageway in said cannula having to the treatment location
beyond the curved path.
[0024] In one embodiment, inserting a trocar into a region of bone
comprises inserting a stylet into the trocar such that the stylet
extends beyond the distal opening of the trocar, and inserting the
stylet and trocar simultaneously into the region of bone such that
the stylet pierces the bone as the trocar is being delivered to a
treatment location.
[0025] In another embodiment, delivering a cannula through the
central channel comprises inserting a straightening stylet into the
central passageway of the cannula, wherein the straightening stylet
comprises a rigid construction configured to straighten the curved
distal tip of the cannula, and inserting the straightening stylet
and straightened cannula simultaneously into the trocar.
[0026] In an alternative embodiment, the straightening stylet
further comprises a sharp distal end to pierce the bone, wherein
the straightening stylet and cannula are installed simultaneously
along with the trocar as the trocar is delivered into the bone.
[0027] In yet another embodiment, extending the cannula past the
distal opening is done by inserting a curved stylet into the
central passageway of the curved cannula such that a distal tip of
the curved stylet extends to at least the distal opening of the
curved cannula, and simultaneously extending the curved cannula and
curved stylet from the distal end of the trocar such that the
curved stylet blocks the distal opening of the curved cannula while
being delivered into the bone.
[0028] In a preferred embodiment, the curved stylet has a curved
distal end corresponding to the curve of the curved cannula, and
wherein the curved stylet reinforces the curved shape of the curved
cannula as the curved cannula is extended past the distal opening
of the trocar. The curved stylet has a sharp distal tip such that
it is advanced within the central passageway so that the curved
stylet extends past the distal opening of the curved cannula such
that the curved stylet pierces the bone as the cannula is delivered
past the distal opening of the trocar.
[0029] In a further step, the curved stylet is removed from the
curved cannula, and a straight channeling stylet is inserted into
the curved distal end of the cannula. The straight channeling
stylet is flexibly deformable to navigate the curved cannula, yet
retain a straight form upon exiting the curved cannula. The
straight channeling stylet is longer than the curved cannula to
create a linear channel beyond the distal tip of the curved
cannula.
[0030] In a preferred embodiment, the trocar is inserted through a
cortical bone region and into a cancellous bone region of a
vertebrae, and the curved cannula is extended though at least a
portion of the cancellous bone region to a location at or near the
treatment location. A preferred treatment location comprises a BVN
of the vertebrae, and treatment is delivered to the treatment
location to denervate at least a portion of the BVN. In one
embodiment, a portion of the BVN is denervated by delivering
focused, therapeutic heating to an isolated region of the BVN. In
another embodiment, a portion of the BVN comprises is denervated
delivering an agent to the treatment region to isolate treatment to
that region. Preferably, the treatment is focused on a location of
the BVN that is downstream of one or more branches of the BVN.
[0031] Another aspect is a kit for channeling a path into bone. The
kit includes a trocar having a central channel and opening at its
distal tip, and a cannula selected from a set of cannulas sized to
be received in said central channel and delivered to said distal
opening. The cannula has a deflectable distal tip with a preformed
curve such that the tip straightens while being delivered through
the trocar and regains its preformed curve upon exiting and
extending past the distal opening of the trocar to generate a
curved path in the bone corresponding to the preformed curve of the
deflectable tip. The cannula comprises a central passageway having
a diameter configured allow a treatment device to be delivered
through the central passageway to a location beyond the curved
path, wherein the set of cannulas comprises one or more cannulas
that have varying preformed curvatures at the distal tip.
[0032] In a preferred embodiment, the one or more cannulas have a
varying preformed radius at the distal tip. In addition, the one or
more cannulas each have distal tips that terminate at varying
angles with respect to the central channel of the trocar. The
length of the distal tips may also be varied. The angle of the
distal with respect to the central channel of the trocar may vary
from 0 degrees to 180 degrees.
[0033] The kit may further include a straight stylet configured to
be installed in the trocar, the straight stylet comprising a sharp
distal tip that is configured to extend beyond the distal opening
of the trocar to pierce the bone as the trocar is being delivered
to a treatment location within the bone.
[0034] In a preferred embodiment, the kit includes a set of curved
stylets having an outer radius sized to fit within the central
passageway of the curved cannula, wherein each curved stylet is
configured to be installed in the curved cannula while the curved
cannula is extended past the distal opening of the trocar. The
curved stylet is configured to block the distal opening of the
curved cannula while being delivered into the bone. Each curved
stylet has a varying curved distal end corresponding to the curve
of a matching curved cannula in the set of curved cannulas. The
curved stylet has a sharp distal tip configured to extend past the
curved cannula to pierce the bone as the cannula is delivered past
the distal opening of the trocar.
[0035] In another embodiment, the kit includes a set of straight
channeling stylets wherein one of the set of stylets is configured
to be installed in the cannula after removing the curved stylet.
The straight channeling stylet is flexibly deformable to navigate
the curved cannula yet retain a straight form upon exiting the
curve cannula. Each of the straight channeling stylets has a
varying length longer than the curved cannula such that the
straight channeling stylet creates a predetermined-length linear
path beyond the distal end of the curved cannula when fully
extended.
[0036] Another aspect is a system for channeling a path into bone,
having a trocar with a proximal end, distal end and a central
channel disposed along a central axis of the trocar and extending
from the proximal end toward the distal end. The trocar comprises a
radial opening at or near the distal end of the trocar, the radial
opening being in communication with the central channel. The system
includes a curveable cannula sized to be received in said central
channel and delivered from the proximal end toward said radial
opening. The curveable cannula comprises a curveable distal end
configured to be extended laterally outward from the radial opening
in a curved path extending away from the trocar, and a central
passageway having a diameter configured allow a probe to be
delivered through the central passageway to a location beyond the
curved path.
[0037] A further aspect is a spine therapy system, comprising: a
trocar having a proximal end, distal end and a central channel;
wherein the central channel is disposed along a central axis of the
trocar and extends from the proximal end toward the distal end;
wherein the trocar comprises a radial opening at or near the distal
end of the trocar, the radial opening being in communication with
the central channel; wherein the trocar is configured to be
deployed through a cortical bone region and into a cancellous bone
region of a vertebral body; a curveable cannula sized to be
received in said central channel and delivered from the proximal
end toward said radial opening; the curveable cannula comprising a
central passageway and curveable distal end configured to be
extended laterally outward from the radial opening in a curved path
extending away from the trocar; wherein the curved path is
generated though at least a portion of the cancellous bone region
of the vertebral body; and a treatment probe configured to be
delivered through the central passageway to a location beyond the
curved path.
[0038] Another aspect is a method for channeling a path into bone
to a treatment location in the body of a patient, comprising the
steps of inserting a trocar into a region of bone near the
treatment location; the trocar having a having a proximal end,
distal end and a central channel disposed therebetween; wherein the
trocar comprises a radial opening at or near the distal end of the
trocar, the radial opening being in communication with the central
channel; delivering a curveable cannula through said central
channel and to said radial opening; and deploying the curveable
cannula laterally outward from the radial opening in a curved path
extending away from the trocar
[0039] Further aspects of the invention will be brought out in the
following portions of the specification, wherein the detailed
description is for the purpose of fully disclosing preferred
embodiments of the invention without placing limitations
thereon.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0040] The invention will be more fully understood by reference to
the following drawings which are for illustrative purposes
only:
[0041] FIG. 1 is a system for generating a curved path in bone
according to the present invention.
[0042] FIG. 2 is a sectional view of the system of FIG. 1
[0043] FIG. 3 illustrates a sectioned view of a vertebral body with
a path bored through the cortical shell.
[0044] FIGS. 4A-F illustrate a method for accessing the BVN with
the system of the present invention.
[0045] FIG. 5 shows an alternative system for generating a curved
path in bone according to the present invention.
[0046] FIG. 6 shows the system of FIG. 5 being installed in a
vertebral body.
[0047] FIGS. 7A-7B show a curved stylet in accordance with the
present invention.
[0048] FIG. 8 illustrates a perspective view of a system for
generating a curved path in bone according to the present
invention.
[0049] FIG. 9 is an exploded view of the system of FIG. 8.
[0050] FIG. 10A-10E show schematic diagrams of the system of FIG. 8
at various stages of deployment during a procedure.
[0051] FIG. 11 is a section view of the proximal end of the system
of FIG. 8 during introduction of the system into the body.
[0052] FIG. 12 is a side view of the distal end of the system of
FIG. 8 during introduction of the system into the body.
[0053] FIG. 13 is a section view of the proximal end of the system
of FIG. 8 after deploying the curveable cannula into the body.
[0054] FIG. 14 is a side view of the distal end of the system of
FIG. 8 after deploying the curveable cannula into the body.
[0055] FIG. 15 is a section view of the proximal end of the system
of FIG. 8 with the drive nut retracted.
[0056] FIG. 16 is a section view of the proximal end of the system
of FIG. 8 after deploying the probe into the body.
[0057] FIG. 17 is a side view of the distal end of the system of
FIG. 8 after deploying the probe into the body.
[0058] FIGS. 18A and 18B are side views of the distal end of the
system of FIG. 8 with the curveable cannula in a stowed and
deployed position respectively.
[0059] FIG. 19A illustrates a perspective view of an alternative
system for generating a curved path in bone according to the
present invention.
[0060] FIG. 19B illustrates the system of FIG. 19A in a deployed
configuration.
DETAILED DESCRIPTION OF THE INVENTION
[0061] Referring more specifically to the drawings, for
illustrative purposes the present invention is embodied in the
apparatus generally shown in FIG. 1 through FIG. 19B. It will be
appreciated that the apparatus may vary as to configuration and as
to details of the parts, and that the method may vary as to the
specific steps and sequence, without departing from the basic
concepts as disclosed herein.
Tube-In-Tube
[0062] FIGS. 1 and 2 illustrate a first embodiment of the present
invention comprising a system or kit 10 for forming a path through
bone. The system comprises a needle trocar 20 (the main body of the
instrument set). The trocar 20 comprises an elongate shaft 28
having a handle 24 at its proximal end 32 and a central lumen 36
passing through to the distal end 22 of the trocar 20. The central
lumen 36 is generally sized to allow the other instruments in the
system 10 to be slideably introduced into the patient to a
treatment region. System 10 further comprises a straight stylet 80
having a sharp-tipped needle 84 at its distal end that is used with
the needle trocar 20 to create the initial path through the soft
tissue and cortical shell to allow access to the cancellous bone, a
curved cannula 50 that is used to create/maintain the curved path
within the bone/tissue. A straightening stylet 40 is used to
straighten out the curve and load the curved cannula 50 into the
needle trocar 20. A curved stylet 60 is used in conjunction with
the curved cannula 50 to create the curved path within the
bone/tissue, and a channeling stylet 90 is used to create a working
channel for a treatment device (such as RF probe 100) beyond the
end of the curved path created by the curved cannula 50.
[0063] The surgical devices and surgical systems described may be
used to ddevices and systems of the present invention are
particularly useful in navigating through bone, it is appreciated
that they may also be used to navigate through soft tissue, or
through channels or lumens in the body, particularly where one
lumen may branch from another lumen.
[0064] The following examples illustrate the system 10 applied to
generating a curve bone path in the vertebral body, and more
particularly for creating a bone path via a transpedicular approach
to access targeted regions in the spine. In particular, the system
10 may be used to deliver a treatment device to treat or ablate
intraosseous nerves, and in particular that basivertebral nerve
(BVN). Although the system and methods provide significant benefit
in accessing the BVN, it is appreciated that the system 10 of the
present invention may similarly be used to create a bone path in
any part of the body.
[0065] FIG. 3 illustrates a cross-sectional view of a vertebra 120.
Recently, the existence of substantial intraosseous nerves 122 and
nerve branches 130 within human vertebral bodies ("basivertebral
nerves") has been identified. The nerve basivertebral 122 has at
least one exit 142 point at a location along the nerve 122 where
the nerve 122 exits the vertebral body 126 into the vertebral
foramen 132.
[0066] Preferably, the basivertebral nerves are at, or in close
proximity to, the exit point 142. Thus, the target region of the
BVN 122 is located within the cancellous portion 124 of the bone
(i.e., to the interior of the outer cortical bone region 128), and
proximal to the junction J of the BVN 122 having a plurality of
branches 130 (e.g. between points A and B along nerve 122).
Treatment in this region is advantageous because only a single
portion of the BVN 122 need be effectively treated to denervate or
affect the entire system. Typically, treatment in accordance with
this embodiment can be effectuated by focusing in the region of the
vertebral body located between 60% (point A) and 90% (point B) of
the distance between the anterior and posterior ends of the
vertebral body. In contrast, treatment of the BVN 122 in locations
more downstream than the junction J requires the denervation of
each branch 130.
[0067] In one approach for accessing the BVN, the patient's skin is
penetrated with a surgical instrument which is then used to access
the desired basivertebral nerves, i.e., percutaneously. In one
embodiment, a transpedicular approach is used for penetrating the
vertebral cortex to access the BVN 122. A passageway 140 is created
between the transverse process 134 and spinous process 136 through
the pedicle 138 into the cancellous bone region 124 of the
vertebral body 126 to access a region at or near the base of the
nerve 122. It is appreciated that a postereolateral approach (not
shown) may also be used for accessing the nerve.
[0068] FIGS. 4A-F illustrate a preferred method for accessing the
BVN with the system 10 of the present invention. First, the
straight stylet 80 is inserted in aperture 26 at the proximal end
32 of needle trocar 20. The straight stylet 80 is advanced down the
central lumen 36 (see FIG. 2) of the trocar 20 until the proximal
stop 82 abuts against handle 24 of the trocar 20, at which point
the distal tip 84 of straight stylet protrudes out of the distal
end 22 of the trocar 20. The tip 84 of the straight stylet 80
preferably comprises a sharp tip for piercing soft tissue and
bone.
[0069] Referring now to FIG. 4A, the assembly (trocar 20 and
straight stylus 80) is advanced through soft tissue to the surface
of the bone. Once the proper alignment is determined, the assembly
is advanced through the cortical shell of pedicle 138 and into the
cancellous interior 124 of the bone.
[0070] After the proper depth is achieved, the straight stylet 80
is removed from the trocar 20, while the trocar 20 remains
stationary within the vertebrae 120. The straightening stylet 40 is
inserted into proximal aperture 52 (see FIG. 2)of the curved
cannula 50 and advanced along the central lumen of the curved
cannula 50 until the stop 42 of the stylet 40 abuts up to the
proximal end of the curved cannula. This forces the distal tip of
the straight stylet through the curved section 56 of the curved
cannula 50 to straighten out the curve 56. It is contemplated that
the straight stylet comprise a hard, non-compliant material and the
distal end 56 of the curved cannula 50 a compliant, yet memory
retaining material (e.g. Nitinol, formed PEEK, etc.) such that the
curved 56 section yields to the rigidity of the straightening
stylet 40 when installed, yet retains its original curved shape
when the stylet 40 is removed.
[0071] As shown in FIG. 4B, once the straightening stylet 40 is
secure and the curved cannula 50 is straight, they are inserted
into the needle trocar 20 and secured. Proper alignment (e.g.
prevent rotation, orient curve direction during deployment) is
maintained by aligning a flat on the upper portion 58 of the curved
cannula 50 to an alignment pin secured perpendicularly into the
needle trocar 20 handle 24. Once the curved cannula 50 is secure,
the straightening stylet 40 is removed, while the curved cannula 50
remains stationary within the trocar 20.
[0072] Referring to FIG. 4C, the curved stylet 60 is then
straightened out by sliding the small tube 68 proximally to
distally on its shaft towards the distal tip 64 or from the distal
tip 64 proximally on its shaft towards the proximal end 62. Once
the curved distal tip 66 is straightened out and fully retracted
inside the small tube 68, the curved stylet 60 is inserted into the
proximal aperture 52 of the curved cannula 50, which still resides
inside the needle trocar 20. As the curved stylet 60 is advanced
into the curved cannula 50, the small tube 68 is met by a stop 55
(see FIG. 4C). As the curved stylet 60 continues to advance the
small tube 68 is held inside the handle of the curved cannula 50.
This allows the curve of the stylet 60 to be exposed inside the
curved cannula 50. To create the maximum force the curve of the two
parts (50 & 60) must be aligned. To ensure alignment the cap on
the curved stylet 60 has an alignment pin 70 which engages with
alignment notch 52 on the proximal end of the curved cannula
50.
[0073] Once the stylet 60 is fully seated and aligned with the
curved cannula 50 the tip of the curved stylet 60 will protrude
from the tip of the curved cannula 50 by about 1/16 to 3/16 inches.
This protrusion will help to drive the curve in the direction of
its orientation during deployment.
[0074] Referring now to FIG. 4D, with the curved stylet 60 and the
curved cannula 50 engaged, the locking nut 58 at the top of the
curved cannula 50 is rotated counter clockwise to allow the cannula
50 and stylet 60 to be advanced with relation to the needle trocar
20 such that the proximal end 52 abuts against the locking nut 58,
advancing the curved cannula 50 and stylet 60 beyond the distal
opening of trocar 20 to generate a curved path in the cancellous
bone region 124. As the curved cannula 50 and stylet 60 are
advanced they will preferably curve at a radius of 0.4 to 1.0
inches through cancellous bone and arc to an angle between 5 and
110 degrees. Once the curved cannula 50 and stylet 60 are deployed
to the intended angle, the locking nut at the top of the curved
cannula 50 is engaged with the needle trocar 20 to stop any
additional advancement of the curved stylet cannula assembly.
[0075] FIGS. 7A-7B illustrate the tip of the curvet stylet 60,
which has been formed with two angles. To help the curve deployment
in the proper direction the curve 66 of the curved stylet 60 is
shaped in a predetermined orientation. The angle on the inside of
the curve 72 is less than the angle on the outside of the curve 74.
This disparity in angle helps the stylet cannula assembly 50 &
60 curve in the bone as bone pushes against outside curve face 74
ensuring the curve radius is maintained during deployment.
[0076] Referring now to FIG. 4E, the curved stylet 60 is then
removed and replaced by the channeling stylet 90. The tip 94 of the
channeling stylet 90 is advanced beyond the end 54 of the curved
cannula 50 towards the intended target treatment zone.
[0077] Referring now to FIG. 4F, once the channeling stylet 90
reaches the target treatment zone, it is removed creating a working
channel 146. Channel 140 will generally have a first section 142
that crosses the cortical bone of the pedicle 138, followed by a
curved path 144. These sections are occupied by curved cannula 50
such that a treatment device fed through the cannula 50 will have
to follow the curve of the cannula 50 and not veer off in another
direction. The channel may further comprise the linear extension
146 in the cancellous bone 124 to further advance the treatment
device toward the treatment site T.
[0078] With the trocar 20 and curved cannula 50 still in place, a
treatment device (e.g. treatment probe 100 shown in FIG. 2, with an
active element 102 on the distal end 104 of elongate flexible
catheter 110 is delivered to the target treatment location T to
perform a localized treatment.
[0079] In a preferred embodiment, the active element 102 is
delivered to the treatment site and activated to delivery
therapeutic treatment energy. The treatment probe may comprise an
RF delivery probe having bipolar electrodes 106 and 108 that
deliver a therapeutic level of heating to stimulate or ablate the
nerve 122.
[0080] It is appreciated that any number of treatment modalities
may be delivered to the treatment site for therapeutic treatment.
For example, treatment may be affected by monopolar or tripolar RF,
ultrasound, radiation, steam, microwave, laser, or other heating
means. Additionally, the treatment device may comprise a fluid
delivery catheter that deposits an agent, e.g. bone cement, or
other therapeutic agent, to the treatment site T. Alternatively,
cryogenic cooling may be delivered for localized treatment of the
BVN. Furthermore, treatment may be affected by any mechanical
destruction and or removal means capable of severing or denervating
the BVN. For example, a cutting blade, bur or mechanically actuated
cutter typically used in the art of orthoscopic surgery may be used
to affect denervation of the BVN.
[0081] In addition to or separate from treating the BVN, a sensor
may be delivered to the region to preoperatively or postoperatively
measure nerve conduction at the treatment region. In this
configuration, the sensor may be delivered on a distal tip of a
flexible probe that may or may not have treatment elements as
well.
[0082] The goal of the treatment may be ablation, or necrosis of
the target nerve or tissue, or some lesser degree of treatment to
denervate the BVN. For example, the treatment energy or frequency
may be just sufficient to stimulate the nerve to block the nerve
from transmitting signal (e.g. signals indicating pain).
[0083] Once the treatment is complete, the probe 100 is withdrawn.
The curved cannula 50 is then withdrawn into the needle trocar 20.
The needle trocar 20 with the curved cannula 50 is then removed and
the access site is closed as prescribed by the physician.
[0084] In the above system 10, the design of the curves 56 and 66
of the curved cannula 50 and curved stylet 60 is such that the
flexible element (e.g. carrying the treatment device) can navigate
through the angular range of deployment of the Nitinol tube of the
curved cannula 50. The curved nitinol tube 50 allows the flexible
element to navigate through a curve within bone without veering off
towards an unintended direction. Cancellous bone density varies
from person to person. Therefore, creating a curved channel within
varying density cancellous bone 124 will generally not predictably
or accurately support and contain the treatment device as it tries
to navigate the curved channel.
[0085] With the system 10 of the present invention, the treatment
device 100 is deployed into the bone through the curved Nitinol
tube of the curved cannula 50, which supports the element as it
traverses through the curve. When it departs from the tube, it will
do so in a linear direction along path 146 towards the target zone.
This allows the user to predictably and accurately deploy the
treatment device towards the target zone T regardless of the
density of the cancellous bone.
[0086] In some embodiments, a radius of curvature that is smaller
than that which can be achieved with a large diameter Nitinol tube
may be advantageous. To achieve this, the curved tube of the curved
cannula 50 may take one of several forms. In one embodiment, the
tube 50 is formed from a rigid polymer that can be heat set in a
particular curve. If the polymer was unable to hold the desired
curve, an additional stylet (e.g. curved stylet 60) of Nitinol, or
other appropriate material, may also be used in conjunction with
the polymer tube to achieve the desired curve. This proposed
combination of material may encompass and number or variety of
materials in multiple different diameters to achieve the desired
curve. These combinations only need to ensure that the final
outside element (e.g. trocar 20) be "disengageable" from the
internal elements and have an inner diameter sufficient to allow
the desired treatment device 100 to pass to the treatment region
T.
[0087] In an alternative embodiment, of the curved cannula 50 may
comprise a Nitinol tube having a pattern of reliefs or cuts (not
shown) in the wall of the tube (particularly on the outer radius of
the bend). The pattern of cuts or reliefs would allow the tube to
bend into a radius tighter than a solid tube could without
compromising the integrity of the tubing wall.
[0088] FIG. 5 illustrates a second embodiment of the system or kit
200 of the present invention that may be used to reduce the number
of steps required for the procedure. The second embodiment includes
a needle trocar 20, straightening stylet 40, used with the needle
trocar 20 and the curved cannula 50 to create the initial path
through the soft tissue and cortical shell to allow access to the
cancellous bone, curved stylet 60 used in conjunction with the
curved cannula 50 to create the curved path within the bone/tissue,
and channeling stylet 90 used to create a working channel for the
probe beyond the end of the curved path created by the curved
stylet.
[0089] In one method according to the present invention, the
straightening stylet 40 is inserted into the curved cannula 50 and
secured. In this embodiment, the straightening stylet 40 has a
sharp tip 46 designed to penetrate bone. Once the straightening
stylet 40 is secure and the curved cannula 50 is straight, they are
inserted into the needle trocar 20 and secured. In this embodiment,
the curved cannula 50 and straightening stylet 40 are inserted into
the shaft 28 of the trocar 20 only as far as to have sharp tip 46
of the straightening stylet 40 protrude from the distal end 22 of
the trocar 20. Proper alignment is maintained by aligning a flat on
the upper portion of the curved cannula 50 with a pin secured
perpendicularly into the needle trocar 20 handle.
[0090] Referring now to FIG. 6, once the curved cannula 50 is
secure, the assembly (trocar 20, curved cannula 50, and
straightening stylet 40) is advanced through soft tissue to the
surface of the bone. After finding the proper alignment at the
pedicle 138 of vertebrae 120, the assembly (trocar 20, curved
cannula 50, and straightening stylet 40) is advanced through the
cortical shell 128 and into the cancellous interior 124 of the
bone.
[0091] After the proper depth is achieved, the straightening stylet
40 is removed. The curved stylet 60 is then straightened out by
sliding the small tube 68 on its shaft towards the distal tip 64.
The curved distal tip 66 is straightened out and fully retracted
inside the small tube 68, and then the curved stylet 60 is inserted
into the curved cannula 50 which still resides inside the needle
trocar 20. Once the curved stylet 60 is inserted into the curved
cannula 50, the small tube 68 is met by a stop 55 (see FIG. 4C). As
the curved stylet 60 continues to advance, the small tube 68 is
held inside the handle of the curved cannula 50. This allows the
curve of the stylet 60 to be exposed inside the curved cannula
50.
[0092] To create the maximum force, it is preferred that the curves
of the two parts (50 & 60) are aligned. To ensure alignment the
cap on the curved stylet 60 has an alignment pin, which engages
with a notch on the top of the curved cannula 50.
[0093] When the stylet 60 is fully seated and aligned with the
curved cannula 50, the tip of the curved stylet 60 will protrude
from the tip of the curved cannula 50 by about 1/16 to 3/16 inches.
This protrusion will help to drive the curved cannula 50 in the
direction of its orientation during deployment. Once the curved
stylet 60 and the curved cannula 50 are engaged, the lock nut at
the top of the curved cannula 50 is rotated counter clockwise to
allow the cannula 50 and stylet 60 to be advanced with relation to
the needle trocar 20 (as shown in FIG. 4D). As the curved cannula
and stylet are advanced they generate a curved path toward the
treatment location T. Once the curved cannula 50 and stylet 60 are
deployed to the intended angle, the lock nut at the top of the
curved cannula 50 is engaged with the needle trocar 20 to stop any
additional advancement of the curved stylet cannula assembly.
[0094] The curved stylet 60 is then removed and replaced by the
channeling stylet 90. The channeling stylet 90 is advanced beyond
the end of the curved cannula 50 (see FIG. 4E) towards the intended
target treatment zone creating a working channel for the active
element to be inserted. Once the channeling stylet 80 reached the
target treatment zone it is removed and replaced by the treatment
device 100, which is delivered to the treatment site T and
activated.
[0095] Once the treatment is complete, the treatment device 100 is
withdrawn. The curved cannula 50 is then withdrawn into the needle
trocar 20. The needle trocar 20 with the curved cannula 50 is then
removed and the access site is closed as prescribed by the
physician.
[0096] FIGS.7A and 7B illustrate detail views of a Nitinol wire for
the curved stylet 60 (proximal end not shown). The wire comprises a
shaft 78 having constant diameter D and a length Ls that may vary
according to the application and desired depth to the treatment
location. The wire has a preformed distal tip that is curved to
have a radius r that redirects the distal tip 64 at an angle
.theta. with the shaft. As shown in FIG. 7A, angle .THETA. is shown
to be approximately 110.degree.. However, it is appreciated that
the preformed tip may have an angle ranging from a few degrees
(slight deflection off axis), to up to 180.degree. (e.g. directing
back toward the proximal end).
[0097] As shown in FIG. 7B detailing the distal tip 64, the tip may
have a distal extension LT that extends away from the shaft 78. To
promote channeling along a path that follows radius r, the distal
tip 64 is configured with dual-plane bevels 74 and 72. Plane 74 is
offset at angle .beta., and plane 72 is offset at angle .alpha..
This configuration of the leading-allows for the stylet and/or
curved cannula to travel through bone in a path correlating to the
specified curve in the stylet and/or cannula.
[0098] In the example illustrated in FIGS. 7A and 7B, the curved
stylet 60 has a shaft length Ls of approximately 3.6 in., diameter
D of approximately 0.040 in., and a distal tip length LT of 0.125
in., radius r of 0.40 in., and angle .beta.=35.degree. and angle
.alpha.=31.degree.. It should be noted that the above dimensions
are for illustration only, and may vary depending on the anatomy an
tissue type.
[0099] It is appreciated that all the above embodiments may be
provided as a kit of instruments to treat different regions of the
body. For example, the location, orientation and angle of the
treatment device with respect to the trocar 20 may be varied by
providing a set of instruments at varying increments. This may be
achieved by varying the curvature (56, 66) in the curved cannula 50
and curved stylet 60. The curvature may be varied by varying the
radius of curvature r, the insertion depth (shaft length Ls and tip
length LT, and/or the final exit angle 0 with respect to the trocar
20 central bore. Thus, the physician may select a different kit for
treating a lumber spine segment as opposed to a cervical spine
segment, as the anatomy will dictate the path that needs to be
channeled.
[0100] Thus, when treating different spine segments, a set out of
the kit may be selected to match the vertebra (or other region
being treated). For example, delivering the treatment device at or
near the BVN junction for a lumbar vertebra may have a different
angle than for a cervical vertebra, and may vary from patient to
patient. The set may be selected from the kit intra-operatively, or
from a pre-surgery diagnostic evaluation (e.g. radiographic imaging
of the target region).
Tube in Windowed Tube
[0101] FIGS. 8-18B illustrate a system 201 for generating a curved
path in bone according to the present invention. FIG. 8 shows a
perspective view of system 201 in a configuration ready for
deployment within a patient's body. System 201 comprises an
introducer/trocar 210 having a proximal end housing 202 coupled to
an elongate delivery tube 204. The distal end tip 208 has a
sharpened and/or beveled tip to facilitate entry into and delivery
through at least a portion of a bony mass such as the vertebral
body.
[0102] The proximal end of the assembly (drive nut 270), may
comprise a hard, rigid material to allow the trocar 210 to be
tapped into place with a mallet or the like.
[0103] The tube body 204 comprises a laterally positioned radial
opening or window 212 disposed just proximal or at the distal tip
208. The window 212 provides radial access from the central channel
218 of tube 204 so that an instrument or probe (e.g. probe 250
distal end) may be delivered at an angle (e.g. non-axial) with
respect to the tube axis or central channel 218.
[0104] FIG. 9 illustrates an exploded view of system 201 prior to
delivery within a patient. While it is preferred that the trocar
210 is introduced to a location near the target treatment site as a
whole assembly shown in FIG. 8, it is also appreciated that the
trocar may be introduced to the location by itself, with the
additional components being positioned once the trocar 210 is in
place. In such a configuration, a stylet (not shown) may be
positioned down the central channel 218 of the trocar 204 so as to
block the aperture 212 from bone fragments or other tissue matter
entering in channel 218. The stylet may have a hard, widened
proximal end to allow the trocar 210 to be tapped into place.
[0105] The proximal end 206 of trocar housing 202 comprises a
centrally-located, counter-bore or recess 216 that is in
communication with trocar channel 218. Trocar recess 216 allows
placement and reciprocation of curveable cannula 230 within the
trocar recess 216 and trocar central channel 218. The curveable
cannula 230 may be held in place at a specified location within the
trocar recess 216 via a stop nut 240 that is threaded about
proximal body 246 of the curveable cannula 230. The curveable
cannula 230 also comprises a central recess 268 within proximal
body 246 that is centrally aligned with cannula channel 245.
Central recess 268 and cannula channel 245 are configured to
receive and allow reciprocation of probe 250, which is threaded
into drive nut 270.
[0106] FIGS. 10A-10E schematically illustrate the system 201 in
various stages of deployment in accordance with the present
invention. FIGS. 11, 13, 15 and 16 illustrate section views of the
proximal end of system 201 through the various stages embodied in
FIGS. 10A-E. Correspondingly, FIGS. 12, 14, illustrate close-up
views of the distal end of system 201 through various the stages
embodied in FIGS. 10A-E.
[0107] FIG. 11 illustrates a sectional view of the proximal end of
system 201 in an un-deployed state prior to or during insertion of
the trocar 210 to the desired treatment location in the patient.
For delivery into a vertebral body 120 (e.g. to access the BVN),
the trocar 210 may be delivered through pedicle 138 via channel 140
(as shown in FIG. 3). Channel 140 may be a pre-drilled hole, or may
be generated by insertion of the sharpened tip 208 into the bone.
To facilitate insertion, the proximal surface 292 of cap 290 of the
drive nut 270 may comprise a rigid material (e.g. stainless steel
or the like) so that a mallet or similar device may strike surface
292 to tap the trocar body 204 into place.
[0108] During insertion of the trocar 210, the stop nut 240 is
threaded distally along external threads 248 of the proximal body
246 of the curveable cannula 230 to restrict motion of the cannula
230 distally down trocar recess 216. This restrained motion keeps
the distal end 232 of the cannula 230 from prematurely deploying
while the trocar 210 is being delivered.
[0109] As shown in FIG. 12, the distal tip 233 of the curveable
cannula 230 comprises a series of tubular mating links 234 each
having a central bore to provide a continuous cannula channel 245
along with cannula tube 244. Cannula channel 245 extends from
central cannula recess 268 of the proximal body 246 to the distal
link 232 at tip 233. Distal link 232 comprises a beveled tip 233 to
facilitate the curveable cannula 230 generating a path through bone
as detailed below. Distal link 232 may also comprise a hard
material, e.g. stainless steel or the like to provide a rigid
leading edge for the curveable cannula 230.
[0110] The mating links 234 are held together with a cord 242 that
runs from the proximal body 246 of the curveable cannula 230, and
terminates at an aperture 236 in the distal link 232. The distal
end of cord 242 terminates at a ball 238 that is disposed in a
counter-bore, countersink, or like retaining surface of the
aperture 236 to retain the cord within the distal link 232.
[0111] Referring now to FIG. 10B, once the trocar 210 is in place,
stop nut 240 is threaded proximally along external threads 248 of
the proximal end 246 of the curveable cannula 230 to allow motion
of the cannula 230 distally downward in recess 214.
[0112] The proximal body 246 of curveable cannula 230 may then be
deployed downward within trocar recess 216, as shown in section
view in FIG. 13. As there may be resistance from the bony mass of
the vertebral body (or other bony mass), the cannula 230 may be
tapped downward by striking the proximal surface of cap 290 (e.g.
with a mallet or the like) while holding the trocar at housing 202.
The motion of proximal body 246 pushes tube 244 distally within
channel 218 of the trocar body 204. This forces the leading edge
232 and trailing mating links 234 out of the radial window 212 in
tube 204, as shown in FIG. 14. The distal end of opening or window
212 comprises a ramp 209 to facilitate the leading edge 232 out the
window 212 at the proper angle with respect to the trocar tube 204
central axis, and without catching or getting stuck at the distal
end of the trocar.
[0113] In addition to the ramp 209, the curved path of the distal
tip 233 is facilitated by tension provided by cord 242, which
forces the mating links 232, 234 to arch upon the applied tension.
The cord 242 is coupled to male-threaded dial 212 (see FIG. 8) to
act as a pull cord to apply said tension. The dial 212 may be
turned clockwise or counterclockwise within internal--threaded arm
214 to increase or relieve the tension on the cord 242, thereby
providing steering of the distal tip 233 while the curved cannula
230 is advanced down trocar body 204 and out window 212 (e.g.
increased tension provides a sharper radius, decreased tension
provides a more relaxed or no radius.)
[0114] Alternatively, cord 242 may comprise a memory material such
as a Nitinol wire that fastens the tube 244 and links 232, 234 in a
preformed curved-shape. The cord 246 in this configuration
stretches to allow the curveable cannula 230 to be delivered into
and stowed in a linear form within channel 218, and retracts when
not restrained in channel 218 to drive a curved path when exiting
window 212.
[0115] As shown in FIGS. 13 and 14, the curveable cannula 230 is
fully deployed, with the proximal end 246 disposed at the bottom of
recess 216, and the distal tip 233 in a deployed orientation
forming a curved path (along with trailing links 234) through the
bone at the treatment site. In this configuration, the probe 250 is
restrained from axial motion (in the distal direction) with respect
to the curved cannula 230, because it is threaded inside drive nut
270, which is restrained from distal motion by stop 258 in the
proximal end 246.
[0116] As shown in FIG. 15, the drive nut 270 may be raised
(proximally advanced out of cavity 268) with respect to the
curveable annula 230 and probe proximal body 254 by rotating the
drive nut. The proximal body 254 of the probe 250 comprises a male
thread 256 that mates with the female internal threads 262 in a
distal recess of the drive nut 270. The thread pattern 256/262 may
preferably be opposite of the thread pattern between the stop nut
240 and proximal end 246 of the curveable cannula 230 (e.g.
right-handed thread vs. left-handed thread), so that rotation of
the drive nut 270 does not result in rotation of the curveable
cannula 230.
[0117] Furthermore, the proximal end 254 of the probe 250 comprises
a plurality of vertical groves 264, at least one of which
interfaces with key 266 of the curveable cannula 230. This
interface only allows axial motion of the proximal body 264 with
the curveable cannula 230, and restricts rotation of the proximal
body 264 with the curveable cannula 230. Thus, rotation of the
drive nut 270 only results in proximal translation of the drive nut
270. As seen in FIG. 15, the probe proximal body 254 is now free to
move downward in cavity 268.
[0118] Referring now to FIGS. 16 and 17, the system 201 is shown in
a fully deployed state, with the probe 250 distal shaft advanced
beyond distal end 233 of the curveable cannula central channel 245.
This is achieved by advancing the proximal body 254 within the
cavity 268 of the curveable cannula 230. The proximal body 254 and
drive nut 270 are advanced as a unit within cavity 268, preferably
by tapping the cap 290, thereby providing an impact force to
advance the probe tip 274 out of the cannula 230 and through
tissue/bone to reach the desired treatment or diagnostic location
within the body.
[0119] In an alternative embodiment, a channeling stylet (such as
stylet 90 shown in kit 10 of FIG. 1) may also be used to create a
working channel beyond the end of the curved path created by the
curveable cannula 230 prior to deploying a probe for treatment or
diagnostic device.
[0120] Once the distal tip 274 of the probe 250 is positioned at
the desired location, treatment of the target tissue may be
performed. As shown in FIG. 17, probe distal end 274 may comprise a
first electrode 274 configured to deliver a therapeutic amount of
RF energy to the target location. In the configuration shown in
FIG. 17, the probe preferably comprises a bipolar probe with return
electrode 276, however it is appreciated that the probe 250 may
comprise any treatment instrument described herein.
[0121] Cap 290 may further be configured to include (e.g. a self
contained unit) a power source (e.g. battery) and receptacles (not
shown) to couple to the probe 250, thereby supplying the energy to
deliver a therapeutic level of energy to the tissue. In this
configuration, the cap 290 may have sufficient power to deliver one
or more metered doses of energy specifically measured to denervate
the BVN of a vertebral body in accordance with the present
invention.
[0122] The cap 290 is preferably treaded (or otherwise releasable
coupled) into drive nut 270 to be interchangeable depending on the
application or step the procedure of the present invention. For
example, a cap 290 having a reinforced/hardened surface 292 used
for driving the system 201 into the bone may be replaced by another
cap having couplings (not shown) for probe 250, an internal power
supply (not shown), or couplings for an external power
supply/controller (not shown) for delivering energy for treatment
and/or diagnosis of a region of tissue. For embodiments wherein a
fluid and/or agent is delivered to the target tissue, the cap 290
may be configured to facilitate delivery of the fluid through a
probe having one or more fluid delivery channels.
[0123] FIGS. 18A and 18B are side views of the distal end of the
system 201 with the curveable cannula 230 in a stowed and deployed
position respectively. The distal link 232 and trailing links 234
are configured to have mating/interlocking surfaces that allow the
distal end of the cannula to curve in one direction. The more
distal link of a mating pair will have an extension 235 that mates
with a correspond depression 237 in the link proximal to it. This
allows the links to rotate with respect to each other to create a
curved distal end as shown in FIG. 18B.
[0124] FIGS. 19A and 19B illustrate an alternative system 300 for
generating a curved channel through bone. System 300 comprises a
tubular trocar body 302, the proximal end (not shown) of which may
comprise a portion or all of any of the previously described
proximal ends for devices 10, 200, or 201 disclosed herein. The
distal tip 334 comprises a leading edge surface for advancing
through bone, and a radial or lateral window 304 allowing access to
the central channel of the trocar body 302. The window 304 is
positioned a short distance proximal to the distal tip 334.
[0125] A curveable cannula 322 is positioned in the trocar 302, the
curveable cannula 322 having a distal end 324 coupled via linkage
326 to a pivotable arm 310. The proximal end (not shown) of the
curveable cannula may comprise a portion or all of any of the
previously described proximal ends for devices 10, 200, or 201
disclosed herein. The pivotable arm 310 has a first end pivotable
coupled at joint 314 at a location at or near the distal tip 334 of
the trocar 334. In a stowed configuration (illustrated in FIG.
19A), the pivotable arm is configured to lay axially in the trocar
302 within slot 306 that runs from pivot 314 proximally to the
radial opening or window 304. The proximal (when stowed) end 312 of
the arm 310 is coupled to the linkage 326.
[0126] As shown in FIG. 19B, the cannula 322 may be advanced
laterally outward from window 304 by simply advancing the cannula
322 distally down the trocar 302. The pivotable arm 310 constrains
the motion of the curveable end 320 of the cannula to a curved path
of specified radius (determined by the length of arm 310. Once the
pivotable arm has reached full rotation (shown approximately 90
degrees in FIG. 19B, however such angle may be specified to be any
desired amount), the cannula end 320 has created a curved path
outward from the trocar toward the desired treatment site. A probe,
stylet or similar device (such as curved stylet 60, channeling
stylet 90, or probe 100 of FIG. 1) may be positioned at the opening
of the distal end 320 to facilitate generating the curved bore
without allowing tissue or bone to enter the cannula. The probe,
treatment/diagnostic device may then be routed through the cannula
end 320 to a region of tissue/bone that is off-axis from the trocar
body 302.
[0127] It is appreciated that the above systems 201, 300 may be
provided as a kit of instruments to treat different regions of the
body. For example, the location, orientation and angle of the
treatment device with respect to the trocar may be varied by
providing a set of instruments at varying increments. This may be
achieved by varying the curvature in the curveable cannula (230,
320). The curvature may be varied by varying the radius of
curvature, the insertion depth (shaft length and tip length, and/or
the final exit angle with respect to the trocar central bore. Thus,
the physician may select a different kit for treating a lumber
spine segment as opposed to a cervical spine segment, as the
anatomy will dictate the path that needs to be channeled.
[0128] It is appreciated that each of the instruments in the
systems 10, 200, 201, and 300 detailed above may have any length,
shape, or diameter desired or required to provide access to the
treatment/diagnostic region (e.g. intraosseous nerve trunk) thereby
facilitating effective treatment/diagnostic of the target region.
For example, the size of the intraosseous nerve to be treated, the
size of the passageway in the bone (e.g. pedicle 138) for accessing
the intraosseous nerve, and the location of the bone, and thus the
intraosseous nerve, are factors that that may assist in determining
the desired size and shape of the individual instruments.
[0129] The systems 10, 200, 201 and 300 described above may be used
with a number of different treatment modalities for therapeutic
treatment of the target region. For example, in one embodiment, it
is desirable to operate the treatment devices or probes in systems
100, 200, 20 and 300 in a manner that ablates the tissue of the
target region (e.g. BVN) to produce heat as described in U.S. Pat.
No. 6,699,242, herein incorporated by reference in its
entirety.
[0130] In another embodiment, the treatment device is configured to
deliver therapeutic treatment that is targeted to block nerve
conduction without ablating the nerve, i.e. thermal treatment is
delivered to the nerve (e.g. via thermal therapy, agent or the
like) that results in denervation of the BVN without necrosis of
tissue. This may be achieved via delivery of a lesser amount of
energy or agent to the tissue site (either in the form of less
exposure time, concentration, intensity, etc.) than is required for
ablation, but an amount sufficient to achieve some amount of
temporary or permanent denervation.
[0131] It is further envisioned that the probed described herein
may comprise non-therapy devices, such as diagnostic devises (e.g.
ultrasound, cameras, or the like) to diagnose a region of tissue
independent of or in connection with treatment of the region of
tissue.
[0132] It is also appreciated that individual elements of any of
the systems 10 200, 201, and 300 detailed above may be used
interchangeably where applicable. For example, the curved stylet 60
shown in systems 10 and 200 may be temporarily implemented in place
of the probe of systems 201 and 300 to provide additional curving
bias to the curveable cannula (230, 320) while the cannula is being
driven into the bone. Furthermore, the channeling stylet 90 may be
used to further generate a channel beyond the curved path provided
by the curveable cannula (230, 320)
[0133] As can be seen, therefore, the present invention includes
the following inventive embodiments among others:
[0134] 1. A system for channeling a path into bone, comprising: a
trocar having a proximal end, distal end and a central channel;
wherein the central channel is disposed along a central axis of the
trocar and extends from the proximal end toward the distal end;
wherein the trocar comprises a radial opening at or near the distal
end of the trocar, the radial opening being in communication with
the central channel; and a curveable cannula sized to be received
in said central channel and delivered from the proximal end toward
said radial opening; the curveable cannula comprising a curveable
distal end configured to be extended laterally outward from the
radial opening in a curved path extending away from the trocar;
wherein the curveable cannula comprises a central passageway having
a diameter configured allow a probe to be delivered through the
central passageway to a location beyond the curved path.
[0135] 2. A system according to embodiment 1, wherein the trocar
further comprises a sharp distal tip configured to pierce through
bone to generate a linear path through bone.
[0136] 3. A system according to embodiment 2, wherein the curveable
cannula comprises a sharpened distal tip configured to pierce
through bone to generate a curved path extending from a linear path
generated by the trocar.
[0137] 4. A system according to embodiment 1, wherein the distal
end of the curveable cannula is deformable so as to be delivered in
a straight configuration through the trocar and deployed in a
curved configuration outward from the radial opening at an angle
with respect to the central axis.
[0138] 5. A system according to embodiment 4, further comprising: a
pull cord coupled to the distal tip of the curveable cannula, the
pull cord extending to the proximal end of the trocar; wherein the
pull cord is configured to apply a tensile force to the distal end
of the curveable cannula to bias the curveable cannula into a
curved configuration.
[0139] 6. A system according to embodiment 5, wherein the tensile
force applied to the distal tip of the curveable cannula may be
controlled from the proximal end of the trocar to steer the
curveable cannula along a desired path.
[0140] 7. A system according to embodiment 4, wherein a distal end
of the curveable cannula comprises a plurality of mating links, the
links configured to articulate into a curved shape.
[0141] 8. A system according to embodiment 4, wherein the central
channel of the trocar terminates at a ramp leading to the radial
window, said ramp facilitating deployment of said curveable cannula
outward from said window.
[0142] 9. A system according to embodiment 1, wherein: the
curveable cannula comprises a proximal end comprising a proximal
body wherein the proximal end of the trocar comprises a housing:
said housing having a proximal recess configured to allow
reciprocation of the proximal body of the curveable cannula;
wherein the proximal recess is in communication with the central
channel.
[0143] 10. A system according to embodiment 9, wherein a proximal
body of the curveable cannula is configured to be releasably
restrained with respect to translation within the trocar
housing.
[0144] 11. A system according to embodiment 10, further comprising
a probe sized to fit within the central channel of the cannula; the
probe comprising a proximal end configured to be releasably
restrained with respect to translation within the cannula proximal
body.
[0145] 12. A system according to embodiment 11, further comprising
a drive nut coupled to the curveable cannula; wherein the drive nut
comprises a hardened proximal surface suitable for applying an
impact force to advance one or more of the trocar, curveable
cannula, or probe through bone.
[0146] 13. A system according to embodiment 12, wherein the drive
nut comprises a threaded distal recess configured to house the
proximal end of the probe.
[0147] 14. A system according to embodiment 12, wherein the
proximal surface of the drive nut comprises an interchangeable cap;
said interchangeable cap configured to provide access to the probe
for providing a therapeutic energy.
[0148] 15. A method for channeling a path into bone to a treatment
location in the body of a patient, comprising: inserting a trocar
into a region of bone near the treatment location; the trocar
having a having a proximal end, distal end and a central channel
disposed therebetween; wherein the trocar comprises a radial
opening at or near the distal end of the trocar, the radial opening
being in communication with the central channel; delivering a
curveable cannula through said central channel and to said radial
opening; and deploying the curveable cannula laterally outward from
the radial opening in a curved path extending away from the
trocar.
[0149] 16. A method according to embodiment 15, further comprising:
delivering a treatment device through a central passageway in the
curveable cannula to a treatment location beyond the curved
path.
[0150] 17. A method according to embodiment 16, further comprising:
delivering a therapeutic amount of thermal energy to the treatment
location.
[0151] 18. A method according to embodiment 17, wherein inserting a
trocar into a region of bone comprises: deploying the trocar
through a cortical bone region and into a cancellous bone region of
a vertebral body; wherein the curved path is generated though at
least a portion of the cancellous bone region of the vertebral
body.
[0152] 19. A method according to embodiment 16, further comprising:
steering the curveable cannula via a pull cord coupled to the
distal tip of the curveable cannula to bias the curveable cannula
in the curved path.
[0153] 20. A method according to embodiment 18, wherein the
treatment location comprises a BVN associated with the vertebral
body, the method further comprising: delivering the thermal energy
to the treatment location to denervate at least a portion of the
BVN.
[0154] 21. A spine therapy system, comprising: a trocar having a
proximal end, distal end and a central channel; wherein the central
channel is disposed along a central axis of the trocar and extends
from the proximal end toward the distal end; wherein the trocar
comprises a radial opening at or near the distal end of the trocar,
the radial opening being in communication with the central channel;
wherein the trocar is configured to be deployed through a cortical
bone region and into a cancellous bone region of a vertebral body;
a curveable cannula sized to be received in said central channel
and delivered from the proximal end toward said radial opening; the
curveable cannula comprising a central passageway and curveable
distal end configured to be extended laterally outward from the
radial opening in a curved path extending away from the trocar;
wherein the curved path is generated though at least a portion of
the cancellous bone region of the vertebral body; and a treatment
probe configured to be delivered through the central passageway to
a location beyond the curved path.
[0155] 22. A system according to embodiment 21, wherein the trocar
further comprises a sharp distal tip configured to pierce through
bone to generate a linear path through bone.
[0156] 23. A system according to embodiment 22, wherein the
curveable cannula comprises a sharpened distal tip configured to
pierce through bone to generate a curved path extending from a
linear path generated by the trocar.
[0157] 24. A system according to embodiment 21, wherein the distal
end of the curveable cannula is deformable so as to be delivered in
a straight configuration through the trocar and deployed in a
curved configuration outward from the radial opening at an angle
with respect to the central axis.
[0158] 25. A system according to embodiment 24, further comprising:
a pull cord coupled to the distal tip of the curveable cannula, the
pull cord extending to the proximal end of the trocar; wherein the
pull cord is configured to apply a tensile force to the distal end
of the curveable cannula to bias the curveable cannula into a
curved configuration.
[0159] 26. A system according to embodiment 24, wherein a distal
end of the curveable cannula comprises a plurality of mating links,
the links configured to articulate into a curved shape.
[0160] 27. A system according to embodiment 21, wherein: the
curveable cannula comprises a proximal end comprising a proximal
body wherein the proximal end of the trocar comprises a housing:
said housing having a proximal recess configured to allow
reciprocation of the proximal body of the curveable cannula; and
wherein the proximal recess is in communication with the central
channel.
[0161] 28. A system according to embodiment 27, wherein a proximal
body of the curveable cannula is configured to be releasably
restrained with respect to translation within the trocar
housing.
[0162] 29. A system according to embodiment 28, wherein the probe
comprises a proximal end configured to be releasably restrained
with respect to translation within the cannula proximal body.
[0163] 30. A system according to embodiment 29, further comprising:
a drive nut coupled to the curveable cannula; wherein the drive nut
comprises a hardened proximal surface suitable for applying an
impact force to advance one or more of the trocar, curveable
cannula, or probe through bone; wherein the drive nut comprises a
threaded distal recess configured to house the proximal end of the
probe; wherein the probe comprises mating threads with the distal
recess so as to allow controlled translation of the probe with
respect to the drive nut.
[0164] 31. A system according to embodiment 30, wherein the
proximal surface of the drive nut comprises an interchangeable cap;
said interchangeable cap configured to provide access to the probe
for providing a therapeutic energy.
[0165] Although the description above contains many details, these
should not be construed as limiting the scope of the invention but
as merely providing illustrations of some of the presently
preferred embodiments of this invention. Therefore, it will be
appreciated that the scope of the present invention fully
encompasses other embodiments which may become obvious to those
skilled in the art, and that the scope of the present invention is
accordingly to be limited by nothing other than the appended
claims, in which reference to an element in the singular is not
intended to mean "one and only one" unless explicitly so stated,
but rather "one or more." All structural, chemical, and functional
equivalents to the elements of the above-described preferred
embodiment that are known to those of ordinary skill in the art are
expressly incorporated herein by reference and are intended to be
encompassed by the present claims. Moreover, it is not necessary
for a device or method to address each and every problem sought to
be solved by the present invention, for it to be encompassed by the
present claims. Furthermore, no element, component, or method step
in the present disclosure is intended to be dedicated to the public
regardless of whether the element, component, or method step is
explicitly recited in the claims. No claim element herein is to be
construed under the provisions of 35 U.S.C. 112, sixth paragraph,
unless the element is expressly recited using the phrase "means
for."
* * * * *