U.S. patent application number 16/281573 was filed with the patent office on 2019-06-20 for minimally invasive implantable neurostimulation system.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Eric H. Bonde, Anthony M. Chasensky, Michael J. Ebert, Phillip C. Falkner, John E. Kast, Shawn C. Kelley, Gabriela C. Molnar, Randy S. Roles, Erik R. Scott, Todd V. Smith, Richard T. Stone, Brad C. Tischendorf, Xuan K. Wei.
Application Number | 20190183472 16/281573 |
Document ID | / |
Family ID | 49881043 |
Filed Date | 2019-06-20 |
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United States Patent
Application |
20190183472 |
Kind Code |
A1 |
Tischendorf; Brad C. ; et
al. |
June 20, 2019 |
MINIMALLY INVASIVE IMPLANTABLE NEUROSTIMULATION SYSTEM
Abstract
A medical device system for delivering a neuromodulation therapy
includes a delivery tool for deploying an implantable medical
device at a neuromodulation therapy site. The implantable medical
device includes a housing, an electronic circuit within the
housing, and an electrical lead comprising a lead body extending
between a proximal end coupled to the housing and a distal end
extending away from the housing and at least one electrode carried
by the lead body. The delivery tool includes a first cavity for
receiving the housing and a second cavity for receiving the lead.
The first cavity and the second cavity are in direct communication
for receiving and deploying the housing and the lead coupled to the
housing concomitantly as a single unit.
Inventors: |
Tischendorf; Brad C.;
(Minneapolis, MN) ; Bonde; Eric H.; (Minnetonka,
MN) ; Falkner; Phillip C.; (Minneapolis, MN) ;
Kast; John E.; (Hugo, MN) ; Roles; Randy S.;
(Elk River, MN) ; Scott; Erik R.; (Maple Grove,
MN) ; Smith; Todd V.; (Shoreview, MN) ; Wei;
Xuan K.; (Minnetonka, MN) ; Chasensky; Anthony
M.; (St. Paul, MN) ; Ebert; Michael J.;
(Fridley, MN) ; Kelley; Shawn C.; (Shoreview,
MN) ; Molnar; Gabriela C.; (Fridley, MN) ;
Stone; Richard T.; (Minneapolis, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
49881043 |
Appl. No.: |
16/281573 |
Filed: |
February 21, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14098608 |
Dec 6, 2013 |
10258789 |
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16281573 |
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61734425 |
Dec 7, 2012 |
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61777804 |
Mar 12, 2013 |
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61734429 |
Dec 7, 2012 |
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61777949 |
Mar 12, 2013 |
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61734446 |
Dec 7, 2012 |
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61777824 |
Mar 12, 2013 |
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61777838 |
Mar 12, 2013 |
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61734436 |
Dec 7, 2012 |
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61777787 |
Mar 12, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36071 20130101;
A61N 1/3727 20130101; A61N 1/3605 20130101; A61N 1/36067 20130101;
A61N 1/37518 20170801; A61N 1/02 20130101; A61N 1/37223 20130101;
A61N 1/3756 20130101; A61N 1/36053 20130101; A61N 1/0551 20130101;
A61N 1/36007 20130101; A61N 1/05 20130101; A61N 1/36021 20130101;
A61N 1/37235 20130101; A61N 1/3754 20130101; A61N 1/36139 20130101;
A61N 1/36057 20130101; A61N 1/3787 20130101; A61N 1/37205 20130101;
A61B 17/00234 20130101; A61N 1/37211 20130101; A61N 1/37247
20130101; F04C 2270/0421 20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61N 1/05 20060101 A61N001/05; A61N 1/36 20060101
A61N001/36; A61N 1/372 20060101 A61N001/372; A61N 1/02 20060101
A61N001/02; A61N 1/375 20060101 A61N001/375; A61N 1/378 20060101
A61N001/378 |
Claims
1. A medical device system for delivering a neuromodulation
therapy, comprising: an implantable medical device comprising: a
housing; an electronic circuit within the housing; an electrical
lead comprising a lead body extending between a proximal end
coupled to the housing and a distal end extending away from the
housing and at least one electrode carried by the lead body; and a
delivery tool for deploying the implantable medical device at a
neuromodulation therapy site, the tool comprising a first cavity
for receiving the housing and a second cavity for receiving the
lead, the first cavity and the second cavity in direct
communication for receiving the housing and the lead coupled to the
housing as a single unit.
2-17. (canceled)
18. A method for delivering an implantable medical device to a
neuromodulation therapy site, comprising: positioning a implantable
medical device housing coupled to an electrical lead in a delivery
tool as a single unit; and deploying the housing and the lead from
the delivery tool concomitantly as a single unit to the therapy
site, the housing enclosing an electronic circuit, the electrical
lead comprising a lead body extending between a proximal end
coupled to the housing and a distal end extending away from the
housing and at least one electrode carried by the lead body, the
delivery tool comprising a first cavity for receiving the housing
and a second cavity for receiving the lead, the first cavity and
the second cavity in direct communication with each other for
receiving the housing and the lead coupled to the housing as a
single unit.
19. The method of claim 18, further comprising deploying the
housing and the lead to position a flattened side of the lead
against a tissue layer.
20. The method of claim 18, further comprising positioning a first
fixation member in the tool to extend through an open side of the
tool, the first fixation member extending from the distal end of
the lead body.
21. The method of claim 20, further comprising: positioning a
second fixation member in the tool to extend through an open side
of the tool, the second fixation member being spaced apart
proximally from the first fixation member along the lead body; and
capturing a tissue layer between the first fixation member and the
second fixation member when the lead distal end is advanced through
a tissue layer.
22. The method of claim 18, further comprising inserting a distal
tool end through a tissue layer to implant the lead distal end
beneath the tissue layer, the housing remaining superficially to
the tissue layer.
23. The method of claim 18, wherein positioning the single unit
comprises: positioning the housing in a tool first shaft portion
extending from a tool handle portion, the tool first shaft portion
comprising a side wall defining the first cavity; and positioning
the lead in an open-sided, hollow needle of a tool second shaft
portion extending from the tool first shaft portion to a distal
tool end and defining the second cavity for receiving the lead; the
single unit extending through a distal opening of the first shaft
portion in direct communication with the open-sided lumen of the
second shaft portion.
24. The method of claim 23, further comprising moving a cover of
the tool to retain the housing and the lead within the tool after
positioning the housing and the lead in the tool, the cover fitting
over at least a portion of one of the first shaft portion and the
second shaft portion.
25. The method of claim 18, wherein positioning the single unit
comprises: positioning the housing in a proximal device guiding
portion of a syringe body of the delivery tool, the device guiding
portion defining the first cavity for receiving the housing and
extending between a proximal end of the syringe body and a distal
needle guiding portion of the syringe body, the distal needle
guiding portion comprising an open sided lumen; and positioning the
lead in a distal hollow needle of a delivery tool plunger, the
distal hollow needle comprising an open-sided lumen defining the
second cavity for receiving the lead, the distal hollow needle
extending through the needle guiding portion of the syringe body
between a proximal plunger end and a distal plunger end, the
plunger further comprising a proximal shaft and a mid-portion
extending from the proximal shaft through the device guiding
portion to the distal hollow needle, wherein deploying the housing
and the lead comprises advancing the plunger through the syringe
body to advance the distal hollow needle out a distal end of the
distal needle guiding portion and the housing out a distal opening
of the device guiding portion.
26. The method of claim 25, further comprising positioning a
fixation member coupled to the lead to extend through an open
groove of the needle guiding portion of the syringe body as the
plunger is advanced.
27. The method of claim 18, further comprising deploying a housing
fixation member to anchor the housing at the therapy site.
28. The method of claim 27, wherein deploying the housing fixation
member comprises one of: advancing a flanged post through an
aperture of the housing, rotating a hook coupled to the housing
into a tissue layer; advancing descending legs coupled to a
cross-beam into a tissue layer to capture the housing between the
tissue layer and the cross-beam, enclosing the housing in a shroud
to which the housing fixation member is coupled, advancing a
serrated body through an aperture of the housing and fixedly
engaging the serrated body with ratcheting collet, and advancing a
U-shaped clip through an aperture of the housing.
29. The method of claim 27, further comprising deploying a housing
fixation member comprising a bioabsorbable material.
30. The method of claim 27, further comprising deploying a housing
fixation member comprising a shape memory alloy.
31. The method of claim 27, further comprising deploying a housing
fixation member comprising an electrode.
32. The method of claim 27, wherein deploying the housing fixation
member comprises anchoring a major side of the housing against a
tissue layer, the major side comprising an electrode electrically
coupled to the electronic circuitry.
33. The method of claim 18, further comprising delivering test
stimulation pulses using an electrode along a distal end of the
delivery tool to identify the therapy site.
34. The method of claim 18, further comprising coupling the lead to
the housing to be non-removable from the housing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional
Patent Application No. 61/734,425, filed Dec. 7, 2012 (Atty. Docket
C00003998.USP1), which application is incorporated herein by
reference as if re-written in its entirety.
[0002] The present application claims priority to U.S. Provisional
Patent Application No. 61/777,804, filed Mar. 12, 2013 (Atty.
Docket C00003998.USP3), which application is incorporated herein by
reference as if re-written in its entirety.
[0003] The present application claims priority to U.S. Provisional
Patent Application No. 61/734,429, filed Dec. 7, 2012 (Atty. Docket
C00004420.USP1), which application is incorporated herein by
reference as if re-written in its entirety.
[0004] The present application claims priority to U.S. Provisional
Patent Application No. 61/777,949, filed Mar. 12, 2013 (Atty.
Docket C00004420.USP3), which application is incorporated herein by
reference as if re-written in its entirety.
[0005] The present application claims priority to U.S. Provisional
Patent Application No. 61/734,446, filed Dec. 7, 2012 (Atty. Docket
C00004588.USP1), which application is incorporated herein by
reference as if re-written in its entirety.
[0006] The present application claims priority to U.S. Provisional
Patent Application No. 61/777,824, filed Mar. 12, 2013 (Atty.
Docket C00004588.USP2), which application is incorporated herein by
reference as if re-written in its entirety.
[0007] The present application claims priority to U.S. Provisional
Patent Application No. 61/777,838, filed Mar. 12, 2013 (Atty.
Docket C00004588.USP5), which application is incorporated herein by
reference as if re-written in its entirety.
[0008] The present application claims priority to U.S. Provisional
Patent Application No. 61/734,436, filed Dec. 7, 2012 (Atty. Docket
P40339.USP1), which application is incorporated herein by reference
as if re-written in its entirety.
[0009] The present application claims priority to U.S. Provisional
Patent Application No. 61/777,787, filed Mar. 12, 2013 (Atty.
Docket P0040339.USP3), which application is incorporated herein by
reference as if re-written in its entirety.
FIELD OF THE DISCLOSURE
[0010] The disclosure relates generally to implantable
neurostimulation systems and in particular to minimally invasive
neurostimulation systems.
SUMMARY
[0011] Various exemplary embodiments of IMD fixation members and
associated methods of deploying and anchoring an IMD are described
using minimally invasive implantation procedures in which the
incision size and time required to implant and anchor the device
can be minimized. The exemplary fixation mechanisms provide stable
positioning of the IMD to promote efficient therapy delivery. In
illustrative embodiments, an exemplary IMD delivery tool is used to
deliver the IMD to a desired implant site and deploy a fixation
member.
[0012] In one embodiment, a medical device system for delivering a
neuromodulation therapy includes an implantable medical device
having a housing and an electrical lead coupled to the housing and
a delivery tool for deploying the implantable medical device at a
neuromodulation therapy site. The tool includes a first cavity for
receiving the housing and a second cavity for receiving the lead
coupled to the housing. The first cavity and the second cavity are
in direct communication with each other for receiving the housing
and the lead coupled to the housing as a single unit. The delivery
tool may include an electrode along a distal end of the tool for
use in testing stimulation sites to identify a neuromodulation
therapy site. The lead may be non-removably coupled to the housing
or it may be removable.
[0013] In various embodiments, the lead may include a lead body
having a flattened side. The lead body may include a first fixation
member along the distal end of the lead body. The lead body may
include a second fixation member spaced apart proximally from the
first fixation member along the lead body such that a tissue layer
is captured between the first fixation member and the second
fixation member when the lead distal end is advanced through a
tissue layer.
[0014] In one embodiment, the delivery tool includes a distal tool
end adapted to be inserted through a tissue layer to implant the
lead distal end beneath the tissue layer, the housing remaining
superficial to the tissue layer. The delivery tool may further
include a handle portion, a first shaft portion extending from the
handle portion defining the first cavity for receiving the housing
and a second shaft portion having an open-sided lumen extending
from the first shaft portion and defining the second cavity for
receiving the lead. The first shaft portion includes a distal
opening in direct communication with the open-sided lumen of the
second shaft portion for receiving the housing coupled to the lead
as a single unit. The tool may include a movable cover fitting over
at least a portion of the first shaft portion or the second shaft
portion to retain the housing and lead within the tool.
[0015] In another embodiment, the delivery tool includes a syringe
body having a distal needle guiding portion and a proximal device
guiding portion. The delivery tool includes a plunger having a
proximal shaft, a mid-portion extending from the proximal shaft and
through the device guiding portion of the syringe body, and a
distal hollow needle having an open sided lumen and extending from
the mid-portion and through the needle guiding portion of the
syringe body. The plunger is configured to deploy the housing and
the lead as a single unit at an implant site when the plunger is
advanced through the syringe body. The needle guiding portion of
the syringe body may include an open groove so that a fixation
member coupled to the lead can extend through the open-sided lumen
of the plunger distal hollow needle and through the groove of the
needle guiding portion of the syringe body as the plunger is
advanced through the syringe body.
[0016] The IMD may include a housing fixation member for anchoring
the housing at an implant site. In various embodiments, a housing
fixation member may include any of a flanged post, a hook, a
cross-beam with descending legs, a shroud, a serrated body and
ratcheting collet, or a U-shaped clip. The housing fixation member
may be formed from a bioabsorbable material or a shape memory alloy
in various examples. The housing fixation member may include an
electrode. The electrode may be positioned along a major side of
the housing with the housing fixation member being adapted to
anchor the major side against a tissue layer to position the
electrode against the tissue layer for delivering neurostimulation
to a nerve beneath the tissue layer.
[0017] In one embodiment, a method for delivering an implantable
medical device to a neuromodulation therapy site includes
positioning an implantable medical device housing coupled to an
electrical lead in a delivery tool as a single unit and deploying
the housing along with the lead from the delivery tool at the same
time, i.e. still coupled as a single unit, to the therapy site.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1A is a schematic diagram of an exemplary minimally
invasive IMD system capable of delivering a neurostimulation
therapy.
[0019] FIGS. 1B-1F are schematic illustrations depicting exemplary
implant locations of an exemplary IMD system for delivering a
neurostimulation therapy relative to a patient's anatomy.
[0020] FIG. 2 is a functional block diagram of the IMD shown in
FIG. 1A according to one exemplary embodiment.
[0021] FIG. 3 is a perspective view of an exemplary IMD that may be
included in an INS system according to one embodiment.
[0022] FIG. 4 is a perspective view of the IMD shown in FIG. 3
after exemplary puncture tips are removed.
[0023] FIG. 5 is a perspective view of an exemplary fixation shroud
according to an illustrative embodiment.
[0024] FIG. 6 is a perspective view of an exemplary implantation
tool adapted for use with the IMD shown in FIG. 3.
[0025] FIG. 7 is a perspective view of the implantation tool of
FIG. 6 after removing IMD from a retaining sleeve.
[0026] FIG. 8 is a side plan view of the implantation tool and the
IMD shown in FIG. 6 after being deploying to desired implant
site.
[0027] FIG. 9 is a perspective view of an exemplary IMD having
active fixation members.
[0028] FIG. 10 is a perspective view of the IMD shown in FIG. 9
after deploying fixation members.
[0029] FIG. 11 is a perspective view of an exemplary IMD including
shape memory fixation members according to an alternative
embodiment.
[0030] FIG. 12 is a perspective view of the IMD of FIG. 11 with the
fixation members in a deployed position.
[0031] FIG. 13 is an exemplary IMD including a fixation member
according to an alternative embodiment.
[0032] FIG. 14 is a perspective view of an exemplary implantation
tool for use in implanting the IMD shown in FIG. 13.
[0033] FIG. 15 is a perspective view of an exemplary IMD and
plunger of the implantation tool shown in FIG. 14.
[0034] FIG. 16 is a close-up bottom perspective view of the plunger
shown in FIG. 15.
[0035] FIG. 17 is perspective view of the plunger of FIG. 15 from a
different angle.
[0036] FIG. 18 is a side view of an exemplary fixation structure
loaded in the hollow needle of the implant tool shown in FIG. 14
according to an alternative embodiment.
[0037] FIG. 19 is a side view of an exemplary IMD fixed at a
desired implant location using the fixation structure shown in FIG.
18.
[0038] FIG. 20 is a close-up perspective view of an alternative
exemplary embodiment of a fixation member loaded in a hollow
needle.
[0039] FIG. 21 is a perspective view of the fixation member shown
in FIG. 20 deployed for anchoring an IMD against a tissue
layer.
[0040] FIG. 22 is a perspective view of an alternative exemplary
embodiment of an IMD fixation member.
[0041] FIG. 23 is a perspective view of an exemplary fixation
member anchoring an IMD against a tissue layer.
[0042] FIG. 24 is a perspective view of the fixation member shown
in FIG. 22 including a compliant grommet.
[0043] FIG. 25 is a perspective view of an alternative exemplary
fixation member including a "U" shaped clip.
[0044] FIG. 26 is a plan view of an exemplary IMD including a
housing enclosing internal IMB circuitry and a lead tethered to the
housing via an electrically insulated, sealed feedthrough.
[0045] FIG. 27A is a perspective view of an exemplary IMD including
a housing and a receptacle for receiving a connector of a lead.
[0046] FIG. 27B is a perspective view of an alternative exemplary
embodiment of an IMD having a tethered lead.
[0047] FIG. 28 is a perspective view of an exemplary IMD including
a housing tethered to an elongated lead adaptor at an electrically
insulated sealed electrical feed through.
[0048] FIGS. 29A and 29B are perspective views of an exemplary
implant tool and the IMD shown in FIG. 26.
[0049] FIG. 30 is a perspective view of the IMD and lead of FIG. 26
after being deployed to an implant site using the implant tool of
FIG. 29A.
[0050] FIG. 31 is a perspective view of another exemplary
embodiment of an implant tool that may be used to deploy an IMD and
lead to a desired implant location in a minimally invasive
procedure.
[0051] FIG. 32 is an enlarged perspective view of a distal portion
of the implant tool of FIG. 31.
[0052] FIGS. 33a-33d show perspective views of an exemplary implant
tool being used to deploy an IMD and lead to a desired implant
site.
[0053] FIGS. 34 and 35 are perspective views of an alternative
exemplary embodiment of an IMD and lead including distal fixation
members and proximal fixation members.
[0054] FIG. 36 is a side view of an exemplary IMD including a
fixation member configured as a curved barb or hook.
[0055] FIG. 37 is a side view of the IMD shown in FIG. 36 after
fixation against a tissue layer.
[0056] FIG. 38 is a side view of an alternative exemplary
embodiment of an IMD including a fixation member hook.
[0057] FIG. 39A is a side view of an exemplary IMD including one or
more electrodes embodied as feedthrough pins extending from IMD
housing.
[0058] FIG. 39B is a perspective view of an exemplary feedthrough
assembly.
[0059] FIG. 40 is an enlarged perspective view of an exemplary
feedthrough pin.
[0060] FIG. 41 is a depiction of a variety of exemplary stamped or
preformed feedthrough pins including variously shaped exemplary
distal ends
[0061] FIG. 42 is a perspective view of an exemplary fixation
member electrode and feedthrough assembly.
[0062] FIG. 43 is a bottom perspective view of an IMD including the
fixation member electrode and feedthrough assembly of FIG. 42.
[0063] FIG. 44 is a perspective view of an exemplary implant tool
for use in a minimally invasive IMD implantation procedure.
[0064] FIG. 45 is a perspective view of an alternative exemplary
embodiment of an implant tool.
[0065] FIG. 46 is a flow chart of an exemplary method for
delivering a neurostimulation therapy.
DETAILED DESCRIPTION
[0066] Applicants have an appreciation that implantable medical
device (IMD) technology is continually advancing as new
applications are developed for automated therapy delivery in
patients. Such advances may be further enhanced by using devices of
reduced size and weight, which makes implantation of such devices
less invasive and chronic use more comfortable for the patient.
Additionally, applicants recognize that such enhancements such as
improved power supply systems, wireless telemetry systems for
communication with the implanted device, tools for performing
implantation procedures, apparatus and methods for targeting a
delivered therapy at a desired location, and other system
improvements can also enhance therapies in a manner that saves
cost, conserves energy and minimizes any burden placed on the
patient or clinician. Accordingly, Applicants recognize a need for
improved, minimally-invasive implantable medical device systems and
associated methods of use for providing patient monitoring and/or
therapy delivery. Certain exemplary embodiments disclosed herein
may obtain some or all of the aforementioned advantages and
enhancements.
[0067] When implanting small devices at targeted monitoring or
therapy delivery locations, stable fixation of the device can be
important, though not necessarily essential, in achieving effective
therapy delivery and/or accurate monitoring of physiological
signals. Stable fixation at a selected implant site can reduce
power requirements of a device delivering an electrical stimulation
therapy because therapy delivery electrodes can be positioned at an
optimal location to deliver therapeutic pulses. Accordingly,
Applicants recognize a need for improved, minimally-invasive
implantable medical device systems and associated methods of use
for providing stationary and/or ambulatory patient monitoring
and/or therapy delivery.
[0068] In the following description, references are made to
illustrative embodiments. Various embodiments of electrodes,
fixation mechanisms and implant delivery tools for an IMD included
in an implantable neurostimulation (INS) system for delivering an
electrical stimulation therapy to a targeted neural site are
described. However, it is recognized that the various embodiments
described herein may be implemented in numerous types of IMDs,
including, for example, implantable sensors or monitoring devices,
implantable communication devices, and other types of implantable
therapy delivery systems. The various embodiments of IMD systems
described herein and associated methods of manufacture promote and
facilitate minimally invasive implantation procedures in which the
incision size and time required to implant and anchor the device
can be minimized. The fixation mechanisms provide stable
positioning of the IMD to promote efficient therapy delivery
(and/or accurate monitoring in a sensing device).
[0069] FIG. 1A is a schematic diagram of a minimally invasive INS
system 10 capable of delivering a neurostimulation therapy. System
10 includes an IMD 20, an external device 40 enabled for
transmitting signals to IMD 20, a patient programming device 60
enabled for bidirectional communication with IMD 20 and/or external
device 40, and a physician programming device 80 according to an
illustrative embodiment. In the illustrative embodiments described
herein, communication between components included in the INS system
10 is configured to be bidirectional communication, however it is
recognized that in some embodiments communication between two or
more system components may be unidirectional.
[0070] IMD 20 includes electronic circuitry comprising one or more
electronic circuits for delivering neurostimulation pulses enclosed
in a sealed housing and coupled to therapy delivery electrodes. In
various embodiments, IMD 20 may include one or more of a primary
battery cell, a rechargeable battery cell, and an inductively
coupled power source for providing power for generating and
delivering stimulation pulses and powering other device functions
such as communication functions.
[0071] In some embodiments, IMD 20 is less than approximately 30 mm
in length, or less than approximately 15 mm in length, and less
than approximately 1 cc in volume. In illustrative embodiments, the
term "approximately" as used herein may indicate a value of +10% of
a stated value or may correspond to a range of manufacturing
specification tolerances. In other examples, IMD 20 may be less
than approximately 10 mm in length and may be less than
approximately 0.6 cc in volume. IMD 20 may be approximately 0.1 cc
in volume in some embodiments. The embodiments described herein are
not limited to a particular size and volume of IMD 20, but are
generally implemented to enable the use of a reduced size device
for minimally invasive implantation procedures and minimized
discomfort to a patient. It is recognized, however, that the
various IMD systems described herein may be implemented in
conjunction with a wide variety of IMD sizes and volumes adapted
for a particular therapy or monitoring application.
[0072] External device 40 may be a wearable device including a
strap 42 or other attachment member(s) for securing external device
40 to the patient in operable proximity to IMD 20. When IMD 20 is
provided with rechargeable battery cell(s), external device 40 may
be embodied as a recharging unit for transmitting power, for
example inductive power transmission from external device 40 to IMD
20. In this embodiment, programming device 60 may be a patient
handheld device that is used to initiate and terminate therapy
delivered by IMD 20 via a bidirectional wireless telemetry link 62.
Alternatively, programming device 60 could be operated by a patient
for communicating with wearable external device 40 to control
therapy on and off times and other therapy control parameters,
which are transmitted to IMD 20 via communication link 21.
Programming device 60 may communicate with wearable external device
40 via a bidirectional wireless telemetry link 41 that may
establish communication over a distance of up to a few feet,
enabling distance telemetry such that the patient need not position
programming device 60 directly over IMD 20 to control therapy on
and off times or perform other interrogation or programming
operations (e.g., programming of other therapy control
parameters).
[0073] When IMD 20 includes primary cell(s), a wearable external
device 40 may be optional. Programming of IMD 20 may be performed
by the programming device 60, using near- or distance-telemetry
technology for establishing bidirectional communication link 62 for
transmitting data between programmer 60 and IMD 20. Programming
device 60 may be used by a patient or clinician to set a therapy
protocol that is performed automatically by IMD 20. Programming
device 60 may be used to manually start and stop therapy, adjust
therapy delivery parameters, and collect data from IMD 20, e.g.
data relating to total accumulated therapy delivery time or other
data relating to device operation or measurements taken by IMD
20.
[0074] When IMD 20 is configured as an externally powered device,
external device 40 may be a power transmission device that is worn
by the patient during a therapy session to provide power needed to
generate stimulation pulses. For example, external device 40 may be
a battery powered device including a primary coil used to
inductively transmit power to a secondary coil included in IMD 20.
External device 40 may include one or more primary and/or
rechargeable cells and therefore may include a power adaptor and
plug for re-charging in a standard 110V or 220V wall outlet, for
example.
[0075] It is contemplated that in some embodiments the
functionality required for transmitting power to IMD 20 when IMD 20
is embodied as a rechargeable or externally powered device and for
programming the IMD 20 for controlling therapy delivery may be
implemented in a single external device. For example, power
transmission capability of external device 40 and programming
capabilities of patient programmer 60 may be combined in a single
external device, which may be a wearable or handheld device.
[0076] Physician programming device 80 may include increased
programming and diagnostic functionality compared to patient
programming device 60. For example, physician programming device 80
may be configured for programming all neurostimulation therapy
control parameters, such as but not limited to pulse amplitude,
pulse width, pulse shape, pulse frequency, duty cycle, therapy on
and off times, electrode selection, and electrode polarity
assignments. Patient programming device 60 may be limited to
turning therapy on and/or off, adjusting a start time of therapy,
and/or adjusting a pulse amplitude without giving access to the
patient to full programming functions such that some programming
functions and programmable therapy control parameters cannot be
accessed or altered by a patient.
[0077] Physician programming device 80 may be configured to
communicate directly with IMD 20 via wireless, bidirectional
telemetry link 81, for example during an office visit. Additionally
or alternatively, physician programming device 80 may be operable
as remote programming instrument used to transmit programming
commands to patient programming device 60 via a wired or wireless
communication network link 61, after which patient programming
device 60 automatically transmits programming data to IMD 20 via
bidirectional telemetry link 62 (or via wearable external device 40
and link 21).
[0078] In some embodiments, the patient may be provided with a
magnet 90 for adjusting operation of IMD 20. For example,
application of magnet 90 may turn therapy on or off or cause other
binary or stepwise adjustments to IMD 20 operations.
[0079] While IMD 20 is shown implanted along a portion of the lower
leg of a patient, IMD 20 could be implanted at numerous sites
according to patient need and the particular medical application.
In the illustrative embodiment, IMD 20 is provided for stimulating
the tibial nerve of the patient to treat overactive bladder
syndrome and is merely one example of the type of medical
application for which INS system 10 may be used. In another
example, IMD 20 may be implanted to deliver a stimulation therapy
to muscles of the pelvic floor, such as periurethral muscles or the
external urethral sphincter for treating symptoms of urinary
incontinence or overactive bladder syndrome. In other examples, IMD
20 may be deployed for delivering neurostimulation therapy to an
acupuncture point for treatment of a symptom associated with the
acupuncture point. IMD 20 may be implemented in an INS system for
providing numerous types of neurostimulation therapies, such as for
pain control, autonomic nervous system modulation, functional
electrical stimulation, tremor, and more.
[0080] FIGS. 1B-1F are schematic illustrations depicting implant
locations of an IMD system for delivering a neurostimulation
therapy relative to a patient's anatomy. FIG. 1B is a schematic
illustration of a medial anatomical view of a portion of a foot and
lower leg. The tibial nerve 51 is shown extending generally
posterior relative to the medial malleolus 52. In one exemplary
embodiment, the implant location of an IMD 50 for delivering a
neurostimulation therapy to the tibial nerve 51 is superficially to
the tibial nerve 51 slightly cephalad to the medial malleolus 52
and superior to the flexor retinaculum 53.
[0081] FIG. 1C is a schematic illustration of a posterior
anatomical view of a portion of a foot and lower leg. The tibial
nerve 51 extends posteriorly to the medial malleolus 52 and extends
beneath the flexor retinaculum 53. In one embodiment, the implant
location of the IMD 50 is over the tibial nerve slightly cephalad
to the medial malleolus. The IMD 50 may be positioned along a
superficial surface of a deep fascia tissue layer that extends
superficially to the tibial nerve 51. In some embodiments as
further described herein, the IMD 50 may be coupled to a lead 55
that may extend superficially to or deeper to a tissue layer
superficial to the tibial nerve 51. For example, a lead 55 may
extend through a deep fascia tissue layer to promote fixation of
IMD 50 and lead 55 and position electrodes near the tibial nerve
51.
[0082] FIG. 1D is a schematic illustration of sectional anatomical
view along a section line 57 in the distal third of a lower right
leg slightly cephalad to the medial malleolus. In one exemplary
embodiment, a minimally invasive IMD 50 is implanted superficial to
the deep fascia 56. In another exemplary embodiment, the minimally
invasive IMD 50 is implanted and secured superior to the
retinaculum, along a deep fascia tissue layer. As shown in FIG. 1D,
IMD 50 may be positioned against a superficial surface of fascia
tissue layer 56, which extends superficially to tibial nerve 51.
Neurostimulation therapy is delivered through the tissue layer
56.
[0083] FIG. 1E is a schematic diagram of an IMD 50 positioned
superficial to a deep fascia tissue layer 56 that extends
superficially to a nerve, e.g. the tibial nerve 51. In some
exemplary embodiments, the minimally invasive IMD 50 is implanted
superficial to the deep fascia near the tibial nerve and
stimulation is delivered through the deep fascia by electrodes 58
incorporated along the IMD housing positioned against the
superficial surface of tissue layer 56. In other exemplary
embodiments, as will be described herein, an electrode portion of
the IMD penetrates through a small opening in the deep fascia and
the power generating portion of the IMD 50 is located superficial
to the deep fascia.
[0084] FIG. 1F is a schematic illustration of an anatomical
variation in the vicinity of the tibial nerve 51. Deep fascia layer
56 bifurcates into a deep fascia layer 56a and the flexor
retinaculum 56b. The deep fascia layer 56a extends superficially to
the Achille's tendon (not shown) and the flexor retinaculum 56b.
The flexor retinaculum 56b extends beneath, i.e. relatively deeper
to, the Achilles tendon and over (superficially to) the tibial
nerve. An IMD 50 may be positioned superficially to deep fascia
layer 56. In some embodiments, an electrode portion of an IMD
system may extend through the fascia layer 56 to position
electrodes in closer proximity to the nerve 51 to reduce the
simulation energy required to provide a therapeutic benefit. In the
example shown, an IMD 50, including a housing enclosing IMD
electronic circuits, i.e., electronic circuitry, is positioned
superficially to fascia layer 56 and an electrical lead 54 coupled
to IMD 50 extends through layer 56 to extend beneath the
retinaculum 56b. Lead 54 carries electrodes 59 positioned in
proximity to tibial nerve 51. In other embodiments, both IMD 50 and
lead 54 extend superficially to deep fascia 56 and 56a and deliver
neurostimulation energy through any of deep fascia layer 56, layer
56a and retinaculum 56b.
[0085] Advancement of lead 54 through deep fascia layer 56 promotes
anchoring of IMD 50 at the implant site. Lead 54 may include
fixation members 49 to further promote anchoring of IMD 50 and
fixation of lead 54 at the therapy delivery site. Fixation members
49 are shown as passive fixation members, such as tines or barbs,
which extend from lead 54 and passively engage in surrounding
tissue without being actively fixed in the surrounding tissue at
the time of implant. Fixation members 49 are shown schematically in
FIG. 1F to extend from a relatively distal portion of lead 54 but
may extend from any portion of lead 54 in any general direction
(not necessarily toward the retinaculum 56b as depicted in the view
of FIG. 1F). For example, the fixation members 49 may extend in a
plane generally parallel to and beneath the retinaculum 56b. Other
positions of passive fixation members are described below. While
not shown explicitly in FIGS. 1E and 1F, passive fixation members
49 may additionally or alternatively extend from a portion of the
housing of IMD 50, for example along lateral sidewalls of the IMD
housing to contribute to the fixation of IMD 50 along a superficial
surface of tissue layer 56.
[0086] As described in detail herein, various embodiments an IMD
system deployed in various implant positions, e.g. as shown in
FIGS. 1B through 1F, can include securing the IMD without piercing
the deep fascia or another tissue layer, for example using passive
fixation members engaging surrounding tissue. In other exemplary
embodiments, the IMD can be secured by suturing to the deep fascia
or another tissue layer or by fixation members that pierce the deep
fascia for actively fixing the IMD location. The minimally invasive
IMD signal generating portion may be located superficial to the
deep fascia near the tibial nerve (or another targeted nerve) and
one or more stimulating electrodes delivering an IMD generated
signal (e.g. stimulation pulses) pierce or pass through the deep
fascia, allowing the stimulating electrode to be located near or
adjacent the tibial nerve (or another targeted nerve).
[0087] FIG. 2 is a functional block diagram of IMD 20 shown in FIG.
1A according to one embodiment. IMD 20 includes a housing 34
enclosing a control unit 22 and associated memory 24, a telemetry
module 26, and a pulse generator 28 coupled to electrodes 30. IMD
20 includes a power supply 32, which as described above may include
any of a primary battery cell, a rechargeable battery cell, and/or
a secondary coil of an externally powered system.
[0088] Control unit 22 may include any one or more of a
microprocessor, a controller, a digital signal processor (DSP), an
application specific integrated circuit (ASIC), a
field-programmable gate array (FPGA), or equivalent discrete or
integrated logic circuitry. In some examples, control unit 22 may
include multiple components, such as any combination of one or more
microprocessors, one or more controllers, one or more DSPs, one or
more ASICs, or one or more FPGAs, as well as other discrete or
integrated logic circuitry. The functions attributed to control
unit 22 herein may be embodied as software, firmware, hardware or
any combination thereof. In one example, a neurostimulation therapy
protocol may be stored or encoded as instructions in memory 24 that
are executed by controller 22 to cause pulse generator 28 to
deliver the therapy via electrodes 30 according to the programmed
protocol.
[0089] Memory 24 may include computer-readable instructions that,
when executed by controller 22, cause IMD 20 to perform various
functions attributed throughout this disclosure to IMD 20. The
computer-readable instructions may be encoded within memory 24.
Memory 24 may comprise non-transitory computer-readable storage
media including any volatile, non-volatile, magnetic, optical, or
electrical media, such as a random access memory (RAM), read-only
memory (ROM), non-volatile RAM (NVRAM), electrically-erasable
programmable ROM (EEPROM), flash memory, or any other digital media
with the sole exception being a transitory, propagating signal.
[0090] Telemetry module 26 and associated antenna 25 are provided
for establishing bidirectional communication with wearable external
device 40, patient programmer 60 and/or physician programmer 80.
Examples of communication techniques used by IMD 20 and a
programming device 60 or 80 include low frequency or radiofrequency
(RF) telemetry, which may be an RF link established via Bluetooth,
WiFi, or MICS, for example. Antenna 25 may be located within, along
or extend externally from housing 34.
[0091] Electrodes 30 may be located along an exterior surface of
housing 34 and are coupled to pulse generator 28 via insulated
feedthroughs or other connections as will be further described
below. In other embodiments, electrodes 30 may be carried by a lead
or insulated tether electrically coupled to pulse generator 28 via
appropriate insulated feedthroughs or other electrical connections
crossing sealed housing 34. In still other embodiments, electrodes
30 may be incorporated in housing 34 with externally exposed
surfaces adapted to be operably positioned in proximity to a
targeted nerve and electrically coupled to pulse generator 28.
[0092] FIG. 3 is a perspective view of an IMD 100 that may be
included in an INS system according to one embodiment. IMD 100
includes a sealed housing 101 having a generally flat profile for
positioning between tissue layers. Housing 101 includes a top face
102 separated from a bottom face 104 by sidewall 106. Housing 101
further includes one or more fixation members 110. Housing fixation
members 110 each include a post 112 extending between a proximal
end 114 fixed to housing bottom face 104 and a distal end 116
extending away from housing face 104. Post 112 is shown having a
circular cross section, but may have other cross-sectional shapes
in other embodiments. In some embodiments, post 112 is a solid
member, and in other embodiments post 112 is a hollow member,
defining an inner lumen.
[0093] Post 112 has a flange 118 at or near distal post end 116.
Post 112 and flange 118 may be a single component formed of a
biostable polymer or as two components bonded together to form a
flanged post. In alternative embodiments, post 112 and flange 118
may be a single component formed of or layered with a conductive
electrode material, such as titanium, platinum, iridium, niobium or
alloys thereof. The post 112 and flange 118 may then function both
as an electrode for delivering a neurostimulation therapy and a
fixation member.
[0094] In other embodiments, flange 118 may be formed of a
different material than post 112. Flange 118 may be formed of an
electrically conductive biostable material, such as those listed
above, and function as an electrode. Post 112 may be formed from a
biostable polymer, ceramic, or other non-conductive material. Post
112 may include an inner lumen through which a conductor extends,
or a conductor may be solidly embedded within post 112, to
electrically couple flange 118 to one or more electronic circuits,
i.e., electronic circuitry, within housing 101. Alternatively, post
112 may be an electrically conductive material and function as an
electrode, and flange 118 may be a non-conductive material, such as
a polymer or a ceramic.
[0095] As shown in FIG. 3, post 112 is terminated by a puncture tip
120, distal to flange 118. Puncture tip 120 includes a proximal
surface 124 configured to mate with flange 118 and may be fixedly
attached to flange 118 at a joint between flange 118 and proximal
surface 124. Puncture tip 120 has a distal sharpened tip 122 for
puncturing through a tissue layer to advance post 112 and flange
118 through the tissue layer.
[0096] In some applications, puncture tip 120 is used to advance
flange 118 through a relatively tough fibrous tissue layer, such as
fascia, tendon, ligament, retinaculum, scar or other connective
tissue. For example, in an application for treating overactive
bladder syndrome, IMD 100 is implanted in the vicinity of the
tibial nerve to deliver neurostimulation to the tibial nerve.
Fixation members 110 are used to secure IMD 100 over the nerve.
Puncture tip 120 is punched through a deep fascia tissue layer
extending over the tibial nerve so that flange 118 becomes
positioned on one side of the tissue layer and IMD housing 101 is
positioned on the other side of the tissue layer. Post 112 extends
through the tissue layer. The flange 118 holds the IMD 100 in place
over (superficially to) the tissue layer near the nerve. When
flange 118 and/or post 112 are formed from conductive material to
operate as electrodes, these electrodes are positioned in close
proximity to the tibial nerve, under the deep fascia tissue layer,
such that stimulation does not need to occur through the tissue
layer, which could require relatively higher stimulation pulse
energy.
[0097] FIG. 4 is a perspective view of IMD 100 shown in FIG. 3
after puncture tips 120 are removed. In one embodiment, puncture
tips 120 are formed from a bioabsorbable or dissolvable material
such that over time tips 120 are removed, leaving post 120 and
flange 118 remaining. Flanges 118 remain as a fixation member
retaining IMD 100 against the deep fascia, or other tissue layer,
through which posts 112 have been advanced. Posts 112 limit
movement of IMD 100 in x- and y-axes and flange 118 limits movement
of IMD 100 in a z-axis. In this way, fixation members 110 limit
movement of IMD 100 in all directions. In the time it takes for
puncture tips 120 to be absorbed or dissolved, fibrotic
encapsulation of IMD 100 will have occurred, which may further
maintain the IMD in a stable position.
[0098] As mentioned previously, post 112 and flange 118 may define
an inner lumen 128 for receiving a male connector 130 of puncture
tip 120. Connector 130 may be press fit into lumen 128. In other
embodiments, flange 118 and post 112 may be solid and puncture tip
120 may be adhesively coupled to flange 118.
[0099] In some embodiments, post 112, flange 118 and puncture tip
120 may be manufactured as a single component from a bioabsorbable
or dissolvable material such that the entire fixation member 110 is
absorbed or dissolved over time, during which fibrotic
encapsulation of IMD 100 takes place. In still other embodiments,
puncture tip 120 and flange 118 may be absorbable or dissolvable
such that over time only post 112 remains to enable easier IMD
removal than when flange 118 remains.
[0100] As indicated previously, all or any portion of post 112 and
flange 118 may function as an electrode. In the embodiment shown in
FIG. 4, for example, the distal surface 126 of flange 118 may
function as an electrode. When two fixation members 110 are
provided as shown, one of the flange surfaces 126 may function as
the cathode and the other of the flange surfaces 126 may function
as an anode. In other embodiments, one or more flange surfaces 126
of one or more fixation members 110 and/or other portions of
fixation members 110 may be electrically tied together to form an
active cathode while the housing 101 functions as the anode.
Housing 101 may carry one or more electrodes (not shown in FIGS. 3
and 4) that may be selected in combination with each other or with
any portion of fixation members 110 to provide electrically active
surfaces for delivering a neurostimulation therapy.
[0101] Posts 112 may be attached to housing 101 on the outer bottom
face 104 by fixedly coupling posts 112 at desired spacings along
housing 101, using welding, brazing, adhesive bonding or other
techniques. Alternatively, posts 112 may extend through housing 101
and be anchored to an inner surface of bottom face 104, e.g. by a
flange, by varying outer diameters of post 112 mating with varying
diameters of an opening through the wall of housing 101 and/or
welded, brazed, or adhesively bonded to an inner surface of bottom
face 104. Post 112 may function as insulation and sealing around an
electrical feedthrough extending through bottom face 104 to enable
electrical connection of flange 118 to electronic circuitry within
housing 101.
[0102] FIG. 5 is a perspective view of a fixation shroud 200
according to an illustrative embodiment. Rather than coupling
fixation members directly to an IMD housing, fixation members may
extend from a shroud sized to snugly surround the IMD. Shroud 200
includes a shroud body 201 and at least one housing fixation member
210 extending from the body 201. In the embodiment shown, shroud
200 includes four spaced apart fixation members, which may
correspond to each of four corners of a face of an IMD.
[0103] Body 201 includes a top face 202 and bottom face 204
separated by opposing end side walls 203 and 205. Outer lateral
edges 206a, 206b (collectively 206) of top face 202 and outer
lateral edges 207a, 207b (collectively 207) of bottom face 204,
respectively, define open lateral sides of shroud body 201. The
open lateral sides defined by outer lateral edges 206 and 207
extend between opposing end side walls 203 and 205.
[0104] Each of top face 202 and bottom face 204 are shown having
inner edges 208 and 209 defining an opening extending along the
respective top and bottom face 202 and 204. Inner edges 208 and 209
may be configured as needed to expose surfaces of the IMD housing
as desired, e.g. to expose electrodes carried on or incorporated in
the IMD housing, expose a lead connector or other otherwise
providing access to features of the IMD. Inner edges 208 and 209
may define openings to reduce the material required to manufacture
shroud 200 and, when manufactured from a bioabsorbable or
dissolvable material, reduces the volume of material that is
absorbed or dissolved.
[0105] Fixation members 210 extend from shroud body 201. In one
embodiment, fixation members 210 extend substantially perpendicular
to shroud body face 204 to urge the IMD retained within cavity 230
defined by shroud body 201 against a tissue through which fixation
members 210 extend. The fixation members 210 include posts 212
extending from a proximal end 214 at bottom face 204 to a distal
end 216 extending away from shroud 200. A flange 218 extends
radially outward at distal end 216, substantially parallel to
bottom face 204. Post 212 terminates in a puncture tip 220 having a
sharpened tip 222 for puncturing through a tissue layer to advance
flange 218 through the tissue layer. The fixation member 210 will
extend through a tissue layer such that shroud body 201 remains on
one side of a tissue layer and flange 218 is positioned within or
on the opposite side of the tissue layer.
[0106] In one embodiment, shroud 200, or at least a portion
thereof, is a bioabsorbable or dissolvable component that will be
fully absorbed or dissolved over time. Tissue encapsulation of the
IMD replaces shroud 200 in limiting movement or migration of the
IMD after shroud 200 is absorbed. Examples of bioabsorbable
materials for use in fixation members described herein include
copolymers of poly-lactic acid and poly-glycolic acid however any
bioabsorbable polymer material could be used.
[0107] In other embodiments, only puncturing tip 220 is formed of a
bioabsorbable or dissolvable device such that flanged posts 212 and
shroud body 201 remain after puncturing tip 220 is absorbed.
Flanged post 212 and shroud body 201 may be molded as one or more
parts from a biostable polymer, such as a high durometer
polyurethane, polyether ether ketone, or polysulfone to provide the
column strength needed to puncture tips 222 through a tissue
layer.
[0108] The shroud 200 may be an overmolded component in which the
IMD is positioned in a mold and shroud 200 is molded onto and
around the IMD. Alternatively, shroud 200 may be pre-molded of a
generally rigid material in which an IMD is inserted into and
retained in cavity 230.
[0109] FIG. 6 is a perspective view of an implantation tool 150
adapted for use with IMD 100 shown in FIG. 3. Tool 150 includes a
tool body extending between a proximal end 152 and a distal end
154. The distal end 154 is a leading end inserted into a surgical
pocket for implantation of IMD 100. The body of tool 150 includes a
proximal portion 156 extending from proximal end 152, a distal
portion 160 extending proximally from distal end 154, and a
mid-portion 158 extending between the proximal portion 156 and the
distal portion 160. Mid-portion 15 optionally extends at an angle
between proximal portion 156 and distal portion 160. In one
embodiment proximal portion 156 and distal portion 160 extend
approximately parallel to each other with mid-portion 158 extending
at an angle therebetween. The angled mid-portion 158 may provide
comfortable ergonomic use of tool 150 and may be provided at
different angles in other embodiments.
[0110] A bracket 162 extends from a bottom surface 155 of tool 150
for receiving an IMD retaining sleeve 170. Distal portion 160 is
characterized by a relatively lower profile than proximal portion
156 in one embodiment such that distal portion 160 can be advanced
into an open incision for implantation of IMD 100 while minimizing
the size of the incision and the size of the pocket formed for IMD
100. As such, proximal portion 156 is shown having a height 166
from a bottom surface 164 of bracket 162. Distal portion 160 has a
smaller height 168 from bracket bottom surface 164 than height 166.
Proximal portion 156 has a thickness or height 166 and overall
length to provide comfortable gripping of tool 150 by a physician,
whereas distal portion 160 may be provided with a relatively
smaller height for advancing through an incision and tunneling to
an implant site and an overall length needed to reach a desired
implant site from the incision site.
[0111] The distal portion 160 includes a bottom recessed surface
165 for receiving IMD 100. IMD retaining sleeve 170 extends through
bracket 162 to distal tool end 154 to secure IMD 100 between
recessed surface 165 and a top surface 174 of sleeve 170. Sleeve
170 includes one or more grooves 172 aligned with fixation
member(s) 110 of IMD 100. In this way, sleeve 170 retains IMD 100
within tool 150 while protecting the puncturing tip of fixation
member 110. Sleeve 170 extends proximally toward proximal end 152
and may extend fully to proximal end 152. Sleeve 170 may have
varying heights such that top surface 174 mates with bottom surface
155 of tool 150.
[0112] During an implantation procedure, the distal portion 160 is
advanced through an incision to position IMD 100 over a desired
implant site. In some embodiments, distal end 154 may include a
sharpened edge for incising or a relatively more blunt edge for
dissecting and creating a tissue pocket within which IMD 100 is
positioned. An incising edge may be provided as an
attachable/detachable member or a retracting member for making a
skin incision and when removed or retracted a relatively more blunt
pocket dissection edge remains along end 154. Alternatively, tool
150 may include a blade cover or guard to be positioned over an
incising edge to cover the incising edge when not in use. The blade
cover or guard may have a blunt dissecting edge to form a tissue
pocket. In other embodiments, edges of tool 150 are blunt or smooth
to prevent trauma and provide comfortable gripping by a
physician.
[0113] After positioning an IMD over a desired implant site, the
sleeve 170 is withdrawn proximally by sliding sleeve 170 through
bracket 162 in a proximal direction. As will be further described
below, in some embodiments tool 150 and other delivery tools
described herein may include nerve locating electrodes for
identifying a nerve location prior to fixation of IMD 100 at an
implant site. For example, an electrode bipole may be formed along
a bottom surface of retaining sleeve 170 and coupled to insulated
conductors extending within or along sleeve 170 to enable
electrical connection to an external pulse generator. Test
stimulation pulses may be delivered via the nerve locating
electrodes as the position of IMD 100 is adjusted until a desired
response is measured or observed. Upon identifying an optimal
implant location, IMD 100 may be fixed at the implant site.
[0114] FIG. 7 is a perspective view of implantation tool 150 after
removing IMD retaining sleeve 170. IMD 100 remains within recess
165 of distal portion 160, but fixation members 110 are now
exposed. IMD 100 is passively retained within recess 165 within the
tissue pocket. Pressure is applied along a top surface of tool 150,
e.g., anywhere along proximal portion 156, mid-portion 158, and/or
distal portion 160 to apply a downward force as generally indicated
by arrow 178 on IMD 100 to force puncturing tips of fixation
members 110 through a tissue layer and thereby secure IMD 100 at
the implant site. A slight tilt upward of tool 150 and/or
withdrawing tool 150 in the proximal direction back out of the
pocket and the incision will release IMD 100 from recess 165,
leaving IMD 100 securely anchored at the implant site by fixation
members 110.
[0115] FIG. 8 is a side plan view of the implantation tool 150 and
IMD 100 shown in FIG. 6 after deploying IMD 100 to desired implant
site. Fixation members 110 have been advanced through a tissue
layer 184, such as a deep fascia tissue layer extending over a
targeted nerve 186, which may be the tibial nerve. Tool 150 has
been advanced via a minimally-sized incision under a tissue layer
180 to form a tissue pocket 182. Downward pressure applied to tool
150 forces puncturing tips 120 through layer 184 such that flanges
118 of fixation members 110 are positioned on an opposite side of
tissue layer 184 from IMD 100. Posts 112 extend through the tissue
layer, and the length of posts 112 may be selected to correspond to
a thickness of layer 184 or a desired depth within layer 184 to
deploy flanges 118.
[0116] When functional as electrodes, fixation members 110 are now
positioned in close proximity to nerve 186 for delivering an
electrical stimulation therapy. When electrodes are incorporated
along the housing of IMD 100, they are held stably against layer
184 for stimulating nerve 186 from above, i.e. superior to, the
tissue layer 184, delivering electrical energy through layer 184.
For example, housing-based electrodes may be used to stimulate the
tibial nerve through a deep fascia tissue layer. Tool 150 is
withdrawn proximally (in the direction of proximal end 152 of tool
150, not visible in the view of FIG. 8), leaving IMD 100 stably
anchored at the implant site. Over time, puncturing tips 120 may
dissolve or absorb leaving only flanges 118 extending through layer
184.
[0117] While tool 150 is shown and described for use in implanting
IMD 100 with fixation members 120, tool 150 may be adapted for use
with an IMD mounted within the fixation shroud 200 shown in FIG. 5.
Retaining sleeve 170 would be appropriately modified to include
grooves mating with fixation members 210 such that the sleeve 170
retains the IMD (held within shroud 200) within a recess 165 of
tool 150. When retaining sleeve 170 is withdrawn proximally from
tool 150, downward pressure applied to tool 150 forces fixation
members 210 into a tissue layer to stably anchor shroud 200
carrying the IMD at the implant site. Tool 150 is withdrawn leaving
shroud 200 and the IMD secured within the shroud at the implant
site. Shroud 200 or portions thereof may dissolve or absorb over
time. Shroud 200 may completely absorb over time leaving only the
IMD at the implant site.
[0118] FIG. 9 is a perspective view of an IMD 300 having active
housing fixation members 310. IMD housing 301 includes a top face
302 and a bottom face 304 separated by opposing pairs of side walls
305, 306 and 307, 308. Housing 301 includes one or more pairs of
lumens 320a, 320b, as indicated by dash line, extending from top
surface 302 to bottom surface 304. In some embodiments, housing 301
includes a polymer enclosure, an overmold portion, or a separate
cavity that is external to a sealed cavity within housing 301,
enclosing IMD circuitry. Lumens 320a, 320b may therefore be
positioned through a housing portion that is exterior to a sealed
housing cavity or sealed circuitry and does not compromise the
hermeticity or fluid resistance of sealed circuitry or a sealed
cavity formed to enclose and protect circuitry from corrosion.
[0119] One or more fixation members 310 each extend through a pair
of lumens 320a and 320b. Fixation member 310 is a substantially "U"
shaped, "staple-like" member, having a cross beam 312 and two
descending legs 314a and 314b, extending from first and second ends
of cross beam 312 through respective housing lumens 320a and 320b.
In the embodiment shown, IMD 300 includes two fixation members 310
extending through lumens positioned adjacent opposing end side
walls 305 and 306 of housing 301. The arrangement of fixation
members 310 and lumens 320 shown in FIG. 9 is illustrative and it
is understood that any number of fixation members may be provided
extending through lumens positioned at desired anchoring locations
along housing 301. In some embodiments, a fixation member 314 is
provided at a single end of IMD 300 corresponding to a location of
electrodes, in particular a location of a stimulating cathode
electrode, positioned along IMD housing bottom surface 304.
[0120] Legs 314a and 314b terminate at free ends 316a and 316b,
collectively 316. Free ends 316 are shown as blunt ends in FIG. 9
but may alternatively be pointed, rounded or include a dissolvable
or absorbable puncturing tip as described above. Free ends 316 may
include features to aid in fixation of legs 314, such as barbs,
hooks or tines. Free ends 316 may initially be retained within
lumens 314a, 314b and be advanced out of the lumens 320, away from
bottom face 304 during an implant procedure.
[0121] FIG. 10 is a perspective view of the IMD 300 shown in FIG. 9
after deploying fixation members 310. Fixation member legs 314a,
314b have a normally flared position as shown in FIG. 10 and are
retained in a straight position when confined within lumens 320.
During an implantation procedure, pressure is applied to cross beam
312, by hand or using an implant tool, to advance fixation members
310, e.g., legs 314a, 314b of fixation members 310, through lumens
320. Legs 314 extend out from lumens 320 and, no longer being
confined within the lumens 320, regain the normally flared
position.
[0122] In the normally flared position, legs 314 include a
descending portion 318 intersecting with a lateral portion 319.
When free end 316 is advanced through a tissue layer, lateral
portion 319 bends or curves into the flared position. In the flared
position, the fixation member legs 314 resist movement up out of
the tissue layer, i.e. in a z-direction, thereby urging and
anchoring IMD housing bottom face 304 against the tissue layer. The
lateral portion 319 may capture a tissue layer between lateral
portion 319 and bottom face 304. Descending portions 318 of legs
314a and 314b resist motion of the IMD 300 in the x- and
y-directions. In this way, IMD 300 is stably anchored at a desired
implant location.
[0123] The fixation members 310 are formed such that legs 314a and
314b have a normally flared position, extending laterally outward.
For example, legs 314 may bend or curve such that lateral portions
319 approach a plane approximately parallel to cross beam 312.
Lateral portions 319 may extend in any direction and are shown to
extend in opposite directions, parallel to end side walls 305 and
306, outward from lateral side walls 307 and 308. In other
embodiments, lateral portion 319 may extend in other directions,
but generally approach a plane that is parallel to bottom face 304
to resist movement in the z-axis. Legs 314 may bend to an
approximately 90 degree angle between descending portion 318 and
lateral portion 319 such that lateral portion 319 is approximately
parallel to bottom face 304. In other embodiments, legs 314 may
bend at an angle that is less than or greater than 90 degrees, for
example an angle between approximately 45 degrees and 135
degrees.
[0124] Fixation member 310 may be formed from nitinol or other
superelastic and/or shape memory material. As described above,
fixation member 310 is configured to assume a normally flared
position, which may occur upon being released from lumens 320
and/or upon reaching body temperature. Fixation member 310 may be
formed as a single component. In some embodiments, legs 314 or at
least a portion thereof are made from a superelastic or shape
memory material and coupled to cross beam 312 which may be formed
from another material. Legs 314 or at least a portion thereof may
function as electrodes for delivering an electrical stimulation
therapy in some embodiments. An extendable conductive interconnect,
such as a serpentine interconnect, or other conductive interconnect
having excess length or strain relief may electrically couple legs
314 to circuitry enclosed in IMD housing 301. Alternatively a
spring contact or other protruding contact formed along lumens 314
may provide electrical connection between legs 314 and IMD internal
circuitry to enable legs 314 to function as electrodes.
[0125] FIG. 11 is a perspective view of an IMD 400 including shape
memory fixation members 410 according to an alternative embodiment.
IMD housing 401 includes a top face 402 and bottom face 404. One or
more housing fixation members 410 extend from bottom face 404 of
housing 401. Fixation member 410 includes a post 412 extending
between a proximal end 418 coupled to bottom face 404 to a distal
free end 416. End 416 is shown as a blunt end but may be a
sharpened or rounded tip or include a dissolvable or absorbable
puncturing tip as described previously.
[0126] FIG. 12 is a perspective view of IMD 400 of FIG. 11 with the
fixation members 410 in a deployed position. Fixation members 410
include a shape memory material, such as nitinol, such that after
IMD 400 is implanted and fixation member free end 416 is advanced
through a tissue layer, such as deep fascia, the fixation members
410 bend to a normally flared position upon reaching body
temperature.
[0127] The normally flared position may correspond to the position
shown in FIG. 12 and generally described above in conjunction with
FIG. 10, though other positions may be taken which effectively
secure fixation member 410 under or within a tissue layer to resist
movement of IMD 400. For example, post 412 will bend such that a
descending portion 417 bends or curves into a lateral portion 419
that approaches a plane parallel to bottom face 404. Free distal
end 416 may extend inwardly under bottom face 404 or outwardly away
at any desired angle. Free distal end 416 may include one or more
protruding features, such as a barb, hook or tine, for aiding in
fixation of post 412. Any protruding features may also be formed of
the shape memory material such that initially a protruding fixation
feature extends alongside the post 412 and becomes flared or
outwardly extending upon reaching body temperature.
[0128] A portion or all of post 412 may be an electrically active
surface for functioning as an electrode. Post 412 may be
electrically coupled to internal IMD circuitry housed in housing
401 via a feedthrough through bottom face 404 or an electrical
interconnect within housing 401.
[0129] FIG. 13 is an IMD 450 including a fixation member 460
according to an alternative embodiment. IMD 450 includes a housing
451 having top face 452 and bottom face 454 separated by end side
walls 455 and 456 and lateral side walls 457 and 458. Housing 451
includes protruding tabs 470, shown extending from end side walls
455 and 456. The positions of tabs 470 are illustrative and may
vary between embodiments.
[0130] Tabs 470 include an inner surface 472 defining an aperture
474 through which a housing fixation member 460 can be threaded.
Fixation member 460 includes a flexible elongate body 462, which
may be a wire or suture, having a fixating structure 464 at
elongate body distal end 463. The elongate body 462 is threaded
through apertures 474 of tabs 470 such that a portion 466 of body
462 extends along top face 452. A proximal end (not shown in FIG.
13) of elongate body 462 may be threaded through a needle in some
embodiments.
[0131] Fixating structure 464 may be in the form of a "T-bar" that
intersects approximately perpendicularly with body 462 as shown in
FIG. 13, but may alternatively be a barb, tine, hook, helix or
other fixating structure. In some embodiments, T-bar structure 464
may further include barbs or tines extending from the T-bar. During
an implant procedure, as will be further described below, the
fixating structure 464 is advanced through a tissue layer, for
example by loading fixating structure 464 into a lumen of a
hypodermic-like needle and puncturing the needle through a tissue
layer.
[0132] When the needle is withdrawn, the fixating structure 464
will resist being pulled back through the tissue layer. Elongate
body 462 can be pulled proximally in the direction indicated by
arrow 480 to remove any slack or excess length of elongate body 462
between tab 470 at end side wall 455 and fixating structure 464. In
this way, tissue is captured between fixating structure 464 and tab
470 at end side wall 455. A proximal end of elongate body 462,
which can be threaded through an eye of a surgical needle, may be
anchored in tissue near tab 470 using a suture stitch that allows
elongate body 462 to be pulled in the proximal direction 480,
tightened across top surface 452, and subsequently knotted or
clipped to hold bottom face 454 securely against the tissue layer
by elongate body 462. Fixation member 460 is anchored in place by
fixating structure 464 at end side wall 455 and by a knotted or
clipped suture stitch at end side wall 456, thereby anchoring IMD
450 in place.
[0133] FIG. 14 is a perspective view of an implantation tool 500
for use in implanting IMD 450 shown in FIG. 13. Implantation tool
500 includes a syringe body 502 and a plunger 530. Syringe body 502
extends from a proximal end 504 to a distal end 506. Distal end 506
may be a smooth or atraumatic end for applying to a tissue layer
490. Alternatively, distal end 506 may be a sharpened dissecting
edge to cut through skin or a blunt dissecting edge for forming the
IMD pocket. Proximal end 504 may include a stop surface 505 to
interface with a plunger stop surface 534.
[0134] Syringe body 502 includes a distal needle guiding portion
510 extending proximally from the distal end 506 and a proximal IMD
guiding portion 508 extending between proximal end 504 and distal
needle guiding portion 510. The needle guiding portion 510 may
include an open side (not seen in the view of FIG. 14), and an
inner surface defining a lumen 514 through which fixation member
460 is guided distally via a hypodermic like needle portion of
plunger 530 (not seen in FIG. 14).
[0135] IMD guiding portion 508 includes an inner surface 512
defining a lumen large enough to retain IMD 450. As plunger 530 is
advanced into syringe body 502, the fixation structure 464 of
fixation member 460 will be inserted through tissue layer 490. As
the plunger 530 is advanced, IMD 450 will be concomitantly ejected
from syringe body 508 through opening 516 defined by inner surface
512 and securely anchored against tissue layer 490 as will be
discussed in greater detail below.
[0136] It is noted that the fixation member 460 is shown to have a
diameter that is exaggerated relative to the IMD 450 size for the
sake of illustration. The diameter of a wire or suture forming
elongate body 462 may be much smaller relative to the IMD 450.
Furthermore, while it is shown to generally have a square
cross-section in the artists' rendering, the elongate body 462 and
T-bar structure may have different cross-sectional shapes, which
may include generally round or flattened cross-sections.
[0137] FIG. 15 is a perspective view of IMD 450 and plunger 530 of
the implantation tool 500 shown in FIG. 14. Plunger 530 extends
between a proximal end 535 and a distal end 537 and includes a
proximal shaft 532, a mid-portion 540, and a distal hollow needle
portion 536. Proximal end 535 includes a stopping interface 534
that enables a user to advance plunger 530 a controlled distance
into syringe body 502 shown in FIG. 14. Distal end 537 is a
sharpened tip of a distal hollow needle portion 536 of plunger 530.
Fixating structure 464 is loaded in hollow needle portion 536.
[0138] Distal hollow needle portion 536 extends along top surface
of IMD 450 and along at least a portion of a mid-portion 540 of
plunger 530. Mid-portion 530 includes a distal face 542 that
interfaces with IMD end side wall 456 within IMD guiding portion
508 of syringe body 502. Distal face 542 may be contoured or
include an open groove to receive tab 470 positioned along end side
wall 456. Elongate body 462 of fixation member 460 may extend
alongside needle portion 546 over the IMD or within a slot or lumen
of needle portion 546. When plunger 530 is advanced, distal face
542 of plunger mid-portion 540 advances IMD 450 out a distal
opening 516 (FIG. 14) of IMD guiding portion 508 of syringe
body.
[0139] Distal hollow needle 536 has a longitudinal central axis 543
offset from a longitudinal central axis 541 of proximal shaft 532.
A second, smaller plunger 550 extends into a lumen of distal hollow
needle portion 536. Second plunger 550 is advanced into hollow
needle portion 536 when the proximal end 535 of plunger 530 is
depressed. Stopping interface 534 of plunger 530 presses against
second plunger head 552, thereby advancing second plunger 550 into
hollow needle portion 536.
[0140] FIG. 16 is a close-up bottom perspective view of plunger
530, and FIG. 17 is perspective view of plunger 530 from a
different angle. Distal needle portion 536 includes an open side
538 that receives fixating structure 464 and enables fixating
structure 464 coupled to the distal end 463 of fixation member body
462 to freely advance along the distal needle portion 536 as the
second plunger 550 is advanced through needle portion 536 when the
proximal end 535 of plunger 500 is depressed into syringe body 502
(FIG. 14).
[0141] Distal sharpened tip 537 is punctured through a tissue layer
490. Then, in one step of depressing plunger proximal end 535,
fixating structure 464 is deployed through the tissue layer 490,
and IMD 450 is delivered concomitantly from the syringe body and
positioned over the tissue layer 490. A proximal end 465 of
elongate body 462 may be pre-threaded on a surgical needle 560.
Fixation member 460 may be provided with an elongate body 462
having a greater length than shown, such that excess length is
available for suturing using needle 560. After removing
implantation tool 500, the needle 560 can be used to anchor end
side wall 456 by placing a suture in close proximity to tab 470
through tissue layer 490, then tightening elongate body 462 over
top face 452 and securing elongate body 462 with a knot or using a
tined elongate body 462 that does not require knotting to be
anchored in place.
[0142] FIG. 18 is a side view of fixating structure 464' loaded in
the hollow needle 536 of the implant tool 500 shown in FIG. 14
according to an alternative embodiment. In this embodiment,
fixating structure 464' includes flexible tines 467 that can
collapse against a shaft portion 468 of fixating structure 464'.
The tines 467 are held against shaft portion 468 when confined
within a lumen of hollow needle 536. Shaft portion 468 is shown
coaxially aligned with respect to a longitudinal central axis of
elongated body 462 and coupled to the elongated body 462 of
fixation member 460'.
[0143] FIG. 19 is a side view of an IMD 450 fixed at a desired
implant location using the fixating structure 464' shown in FIG.
18. With continued reference to FIG. 18, distal sharpened tip 537
is advanced through tissue layer 490. When the second needle
plunger 550 is advanced distally in hollow needle 536, fixating
structure 464' is advanced out a distal opening of needle 536.
Needle 536 is withdrawn allowing tines 467 to expand to a normally
flared position as shown in FIG. 19. Tines 467 resist withdrawal of
fixation member 460' through the tissue layer 490. Elongate body
462 extends through tabs 470a and 470b on respective end side walls
455 and 456 and across top face 452.
[0144] Elongate body 462 is guided through tissue layer 490 using a
surgical needle to secure IMD 450 in the vicinity of end side wall
456 with a suture 482 through tissue layer 490. A knot or clip 484
on elongate body 462, on the outer surface of tissue layer 490,
secures elongate body 462 in a taut position to anchor IMD 450
against tissue layer 490 at the implant site.
[0145] FIG. 20 is a close-up perspective view of an alternative
embodiment of a fixation member 610 loaded in a hollow needle 602.
Fixation member 610 includes an elongate body 612 having a serrated
surface 616. Fixation member 610 further includes a flange 614
having a first end 613 attached at or near a distal end 618 of body
612. A second, free end 615 of flange 614 extends outward from a
longitudinal center axis of body 612.
[0146] Hollow needle 602 has a sharpened distal tip 606 for
penetrating a tissue layer for deploying flange 614 in or beneath a
tissue layer at a target implant site. Hollow needle 602 may
include an open side or slot 604 that enables flange 614 to project
outward when fixation member 610 is loaded in needle 602. In other
embodiments, flange 614 may be collapsed against elongate body 612
when confined within a closed lumen of needle 602.
[0147] In one embodiment, fixation member 610 may be confined
within a proximal closed lumen portion 608 until distal tip 602 is
advanced a desired depth within or through a tissue layer. Fixation
member 610 may then be advanced out of a distal opening 605. Open
side 604 of the distal portion of needle 602 allows flange 614 to
project outward but not until flange 614 is beneath or within the
tissue layer. When needle 602 is withdrawn, flange 614 resists
withdrawal of the fixation member 610.
[0148] FIG. 21 is a perspective view of fixation member 610 shown
in FIG. 20 deployed for anchoring an IMD 450 against a tissue layer
490. IMD 450 includes a tab 470 having an inner surface defining an
opening as shown and described previously. In FIG. 21, IMD 450 is
shown having only one tab 470, however, IMD 450 may include
multiple tabs 470 for use in anchoring IMD 450 at a desired implant
site. The location of tab 470 on IMD 450 is illustrative and it is
recognized that one or more tabs may be positioned along any side
wall of IMD 450.
[0149] Needle 602 is advanced through the opening in tab 470 to
deploy flange 614 beneath tissue layer 490 as generally described
in conjunction with FIG. 20. A ratcheting collet 620 is then
advanced down elongate body 612. Ratcheting collet 620 includes an
interlocking inner surface 622 that interlocks with a serration on
elongate body serrated surface 616 (shown in FIG. 20).
[0150] Ratcheting collet 620 freely moves distally along elongate
body 612 (toward distal end 618) but by interlocking with serrated
surface 616, ratcheting collet 620 cannot be moved proximally along
elongate body 612. Accordingly, ratcheting collet 622 is advanced
along elongate member 612 until tab 470 is firmly held against
tissue layer 490 and tissue layer 490 is securely captured between
flange 614 and tab 470. Elongate body 612 may then be trimmed off
just above ratcheting collet 620. In some embodiments, the serrated
surface 616 may be terminated a distance from distal end 618 to
prevent over-tightening of the fixation member 610 potentially
causing excessive squeezing of tissue layer 490.
[0151] FIG. 22 is a perspective view of an alternative embodiment
of an IMD fixation member 660. Fixation member 660 includes a shaft
662 and head 670 having a diameter greater than shaft 662 and
greater than the aperture 474 defined by inner surface 472 of IMD
tab 470. Shaft 662 includes distal flanges or tines 664 that
protrude radially outward from shaft 662. Tines 664 may be inwardly
flexible. Tines 664 are attached to shaft 662 at or near a shaft
distal end 666. Shaft distal end 666 may be pointed to facilitate
advancement through tissue layer 490.
[0152] Fixation member 660 is advanced through aperture 474 of tab
470 and through tissue layer 490 using an implant tool 650. Tool
650 includes a handle portion 652 and a tool shaft 656 having a
distal end 658. Handle portion 652 includes a distal face 654 for
interfacing with a top surface 672 of head 670 when tool shaft 656
is advanced into a central lumen 674 of fixation member 660.
Central lumen 674 may have a closed end such that distal end 658
meets with a closed end of lumen 674 (not shown in the perspective
view of FIG. 22) to apply force to insert fixation member 662
through tissue layer 490.
[0153] Fixation member 660 is pushed through tab 470 until head 670
meets tab 470. Accordingly, a length of fixation member shaft 662
can be selected to reach a desired depth of deploying tines 664
beneath or within tissue layer 490.
[0154] FIG. 23 is a perspective view of housing fixation member 660
anchoring IMD 450 against tissue layer 490. Tines 664 have been
deployed beneath tissue layer 490 to resist movement of IMD 450 in
a z-direction and migration of IMD 450 along tissue layer 490. A
second fixation member 660 may be employed (through a second tab)
to resist movement of IMD 450 in all directions. Tab 470 and tissue
layer 490 are captured between fixation member head 670 and tines
664. Fixation member 660 may be wholly or partially formed from a
polymer such as a polyurethane, polysulfone, epoxy, silicone or
other biostable polymer material. Alternatively fixation member 660
or portions thereof may be formed of a bioabsorbable material that
will be absorbed over time, providing early fixation after implant,
until tissue encapsulation takes place and allowing easier
explantation of IMD 450 at a later time. In other embodiments,
fixation member 660 or portions thereof may be formed of a metal,
such as but not limited to titanium, stainless steel, or platinum
or alloys thereof.
[0155] FIG. 24 is a perspective view of the fixation member 660
shown in FIG. 22 including a compliant grommet 675. In some
embodiments, fixation member 660 may be formed of an elastomer such
as polyurethane 80A or silicone. The fixation member 660 has a
durometer sufficient to be forced through the tissue layer 490,
which may vary depending on the properties of tissue layer 490, and
elasticity that enables it to return to an original dimension. The
length of shaft 662 may be selected to provide a snug but compliant
"fit" around tissue layer 490 and tab 470.
[0156] In other embodiments a fixation member 660 may be fabricated
from a rigid material. In these embodiments, a compliant grommet
675 circumscribing shaft 662 may be included to provide the desired
compliance of fixation member 660 when tissue layer 490 is
sandwiched between tines 664 and head 670.
[0157] FIG. 25 is a perspective view of an alternative fixation
member 680 including a "U" shaped clip 688. Fixation member 680
includes a proximal head 682 and a shaft 684 extending from the
proximal head 682 to a distal end 686. Fixation member shaft 684 is
fabricated from nitinol or another shape memory or super elastic
material having a normally curved position in the "U" shape as
shown in FIG. 25. When confined within the lumen of an implantation
tool, such as a hollow needle, fixation member shaft 684 is
retained in a straight position. The needle is advanced through tab
470 and tissue layer 490 to position distal end 686 under tissue
layer 490. As the needle is withdrawn, shaft 684 springs back into
the normal, pre-formed "U" shaped position. Distal end 686 will
pierce upward through tissue layer 490 to meet shaft 684 along a
proximal portion of shaft 684 as shown. Distal end 686 may be
provided as a sharpened tip to facilitate piercing back through
tissue 490. The resulting "U" shaped clip 688 holds tab 470 in
place thereby anchoring a position of IMD 450 over tissue layer
490.
[0158] In an alternative embodiment, the shaft 684 is hollow and an
implantation tool includes a wire or shaft that extends through the
fixation member shaft, holding it in a straight position until it
has been advanced through tab 470 and into a tissue layer. Upon
removing the tool from the fixation member shaft, the shaft assumes
a deployed, U-shaped position.
[0159] In the embodiments described above, the IMDs are generally
shown as leadless devices in which electrodes may be incorporated
in or along the housing of the IMD. Stimulation of a nerve
underlying tissue layer 490 occurs through tissue layer 490 when
electrodes are positioned along the IMD housing. In other
embodiments, electrodes may be carried by a lead extending away
from the IMD. Secure anchoring of the IMD and the lead during a
minimally invasive procedure is desired. Techniques and tools are
described below for anchoring an IMD and lead system during a
minimally invasive procedure. FIGS. 26-28 depict various
embodiments of an IMD system for delivering neurostimulation
therapy that include electrodes carried by a lead extending away
from the IMD housing.
[0160] FIG. 26 is a plan view of an IMD 700 including a housing 702
enclosing internal IMD circuitry and a lead 706 tethered to the
housing 702 via an electrically insulated, sealed feedthrough 704.
The lead 706 is tethered to the IMD 700 in that it is not designed
to be disconnected from housing 702. Rather, IMD 700 comes
assembled as a single unit including both the housing 702 and
associated circuitry tethered in a non-removable manner to lead
706. Lead 706 includes one or more electrodes 708 spaced apart and
typically carried near a distal lead end. The electrodes 708 are
coupled to internal IMD circuitry via electrical feedthrough 704
and conductors extending through lead 706 between electrodes 708
and feedthrough 704. In one example, lead 706, and other leads
coupled to an IMD housing described herein for deployment as a
single unit with the IMD, is not more than approximately 5 cm in
length. In another example, lead 706 is less than approximately 2
cm in length. In yet another example, lead 706 is approximately 1
cm in length or less.
[0161] FIG. 27A is a perspective view of an IMD 710 including a
housing 712 and a feedthrough receptacle 714 for receiving a
connector 719 of a lead 716. One or more electrodes 718 are
electrically coupled to circuitry enclosed in IMD housing 712 via
connector 719, which is coupled to insulated feedthroughs in
receptacle 714. Alternatively, the lead 716 may be bonded to
housing 712, e.g. using a braze, weld, locally heated glass seal,
or other joining methods such that lead 716 is a
non-removable/non-disconnectable lead. The lead 716 includes a
proximal connector portion 717 and a flattened distal paddle
portion 715 carrying multiple electrodes 718 adapted to be
positioned along a targeted nerve, e.g. the tibial nerve, for
delivering a neurostimulation therapy. Distal paddle portion 715
may be adapted for positioning and extending superior to, and
possibly superficially to, the flexor retinaculum with electrodes
718 selectable for delivering stimulation pulses to the tibial
nerve through a deep fascia tissue layer. Alternatively, at least a
portion of paddle-shaped portion 715 may be inserted beneath (or
deeper than) the retinaculum and/or a deep fascia tissue layer to
position electrodes in closer proximity to the tibial nerve. IMD
housing 712 and/or lead 716 may be anchored to the deep fascia, or
other tissue layer, using any of the fixation methods described
above.
[0162] FIG. 27B is a perspective view of an alternative embodiment
of an IMD 730 having a tethered lead 740. IMD 730 includes a sealed
housing 732, which may include an end cap 736 bonded or welded to a
first housing end 738 and an enclosure 734, which may be an
overmold member that seals and protects joints or seams of the
housing 732. A proximal end 742 of lead 740 is tethered to housing
732 at a second housing end 739. Lead proximal end 742 may serve as
an end cap to seal a cavity enclosed within housing 732. Electrical
conductors extending from electrodes 748 extend through lead 740 to
proximal end 742 where they may be electrically coupled to IMD
circuitry via electrical feedthroughs at housing end 739.
[0163] Lead 740 includes a flattened paddle portion 744 carrying
electrodes 748. Paddle portion 744 has a thin, flattened
cross-section as compared to the semi-circular cross-section of
paddle portion 715 of FIG. 27A. A flattened side of lead 740
facilitates positioning of the flattened side against a tissue
layer upon deployment from a delivery tool. IMD housing 732 has a
generally circular cross-section as compared to a rectangular
cross-section of the IMD housing 712 in FIG. 27A. It is
contemplated that a lead body shape, i.e. a paddle portion of a
lead tethered or connected to an IMD housing, may vary in
cross-section between embodiments. The cross-sectional shape of the
lead and size and spacing of electrodes carried by the lead may be
adapted for a particular anatomical fit at a targeted therapy site.
Likewise, the IMD cross-sectional shape and overall size may be
adapted for a particular anatomical fit at a targeted implant
site.
[0164] The housings 712 and 732 shown in FIGS. 27A and 27B and
other housings described herein may be adapted to have a variety of
polygonal, circular, elliptical or other rounded cross-sectional
shapes and profiles to best suit a particular implant site,
implantation delivery tool, implantation procedure or other
application-specific requirements. For example, an IMD having a
semi-circular or semi-elliptical shape or other convex profile may
be particularly well-suited for implantation superior to the flexor
retinaculum in the region of the medial malleolus for delivering a
neurostimulation therapy to the tibial nerve. The anatomical
contour in this region includes a concave portion along which a
convex portion of the IMD housing, which may be carrying
stimulation electrodes, may be positioned to naturally conform to
the patient's anatomy in a stable, comfortable and unobtrusive
manner.
[0165] FIG. 28 is a perspective view of an IMD 720 including a
housing 722 tethered to an elongated lead adaptor 724 at an
electrically insulated sealed electrical feedthrough 726. Lead
adaptor 724 includes a receptacle 728 configured to receive a
connector of a lead that is electrically coupled to IMD 720 for
delivering neurostimulation pulses via electrodes carried by the
lead. Rather than being connected/disconnected at a receptacle
formed along a side of or incorporated in the IMD housing 712, the
receptacle 728 is extended away from IMD 722 by adaptor 724.
[0166] FIG. 29A and FIG. 29B are perspective views of an implant
tool 750 shown in open and closed positions, respectively, with IMD
700 shown in FIG. 26 positioned in the tool 750. The tools and
techniques described below in conjunction with FIGS. 29-35 refer to
the IMD 700 shown in FIG. 26 for illustrative purposes. The
embodiments shown in FIGS. 29-35, however, may be adapted for use
with any of the embodiments of IMD systems shown in FIGS. 26-28
which include a lead or adaptor extending from the IMD housing that
may be removably or non-removably tethered to the IMD to form a
single IMD-lead unit. For example, the size and dimensions of
cavities or lumens for receiving the IMD and the lead may be
adapted as needed to receive different shapes and sizes of IMD-lead
units.
[0167] Implant tool 750 includes a handle portion 752, a first
shaft portion 754 and a second shaft portion 758. First shaft
portion 754 is at least partially hollow and extends between handle
portion 752 and second shaft portion 758. A side wall 756 of first
shaft portion 754 defines an opening or cavity 760 in shaft portion
754 for receiving IMD 700. In some examples, first shaft portion
754 may comprise a tubular portion and side wall 754 defining
cavity 760.
[0168] Second shaft portion 758 extends from first shaft portion to
a distal tool end 764 and is an open-sided, hollow needle defining
a cavity for receiving lead 706 tethered to IMD 700. The distal
opening 762 of first shaft portion 754 communicates directly with
the open-sided lumen second shaft portion 758 so that IMD 700 and
lead 706 coupled to IMD 700 can be positioned into tool 750 as a
single unit.
[0169] Tool 750 may include a removable or movable cover 755. Cover
755 may be moved to retain the housing of IMD 700 and lead 706
within the tool after positioning the housing and the lead in the
tool, where the cover may fit over at least a portion of one of
first shaft portion 754 and second shaft portion 758. Cover 755 may
be, for example a slidable, hinged, or clam shell cover, fitting
over at least a portion of one or both of first shaft portion 754
and second shaft portion 758 to enclose or retain IMD 700 and lead
706 after being installed in cavity 760 and the lumen of second
shaft portion 758 respectfully. In the example shown, cover 755 is
a slidable cover that retains IMD 700 within cavity 760. Cover 755
may glide along ridges 753 formed along lateral sides of first
shaft portion to enable an open position as shown in FIG. 29A for
insertion and removal of IMD 700 and a closed position as shown in
FIG. 29B for removal of IMD 700. Cover 755 may further include a
grip 757 or other friction feature that enables a user to apply
pressure to slide cover 755 between open and closed positions.
[0170] In operation, after IMD 700 and lead 706 are inserted into
too 750, cover 755 is moved to a closed position. The tool 750
would be turned over to face the cover 755 down toward a tissue
pocket and advanced into an implant site.
[0171] Distal tool end 764, which may include a sharpened or tissue
penetrating tip, may be inserted through a tissue layer to implant
a distal end of lead 706 and one or more electrodes carried by lead
706 along or beneath a tissue layer at a desired implant site.
After inserting lead 706 to a desired tissue depth, the cover 755
may be slid open or removed so that IMD 700 and lead 706 can be
fully removed from tool 750.
[0172] FIG. 30 is a perspective view of IMD 700 and lead 706 after
being deployed to an implant site using tool 750. Lead 706 extends
through tissue layer 490 positioning electrodes 708 beneath tissue
layer, in proximity to a targeted nerve. In this embodiment, lead
706 is shown to further include fixation tines 708. Fixation tines
708 may be flexible tines that are conformed along lead 706 when
confined within second shaft portion 758 and expand to promote
fixation of lead 706 beneath tissue layer 490. IMD 700 remains
above tissue layer 490. In some applications, lead 706 and IMD 700
remain above layer 490, and tines 708 promote stable positioning of
lead 706 along the tissue layer 490. The use of tool 750 enables
implantation of IMD 700 and lead 706 and fixation of lead 706 in a
single step. It is contemplated that other fixation members
described above may be implemented with IMD 700 for anchoring IMD
700 to tissue layer 490.
[0173] FIG. 31 is a perspective view of an another embodiment of an
implant tool 800 that may be used to deploy IMD 700 and lead 706 to
a desired implant location in a minimally invasive procedure.
Implantation tool 800 includes a syringe body 802 and a plunger
830. Syringe body 802 extends from a proximal end 804 to a distal
end 806. Distal end 806 may be a smooth or blunt end for applying
to a tissue layer 490. Alternatively, distal end 806 may be a
cutting or dissecting edge to cut through skin and/or dissect the
IMD pocket. Proximal end 804 may include a stop surface 805 to
interface with a plunger stop surface 834.
[0174] Syringe body 802 includes a distal needle guiding portion
810 extending proximally from the distal end 806 and a proximal IMD
guiding portion 808 extending between proximal end 804 and distal
needle guiding portion 810. The needle guiding portion 810 may
define an open sided lumen 814.
[0175] IMD guiding portion 808 defines an inner lumen large enough
to retain IMD 700 (indicated by dashed line). Plunger 830 extends
between a proximal end 835 and a distal end 837 and includes a
proximal shaft 832, a mid-portion 840 (enclosed within IMD guiding
portion 808), and a distal hollow needle portion 836 extending
through the open sided lumen 814 of distal needle guiding portion
810 of syringe body 802. Proximal end 835 includes a stopping
interface 834 that enables a user to advance plunger 830 a
controlled distance into syringe body 802. Distal end 837 is a
sharpened tip of a distal hollow needle portion 836. Fixation lead
706 is loaded in hollow needle portion 836 and IMD 700 is loaded in
IMD guiding portion 808, e.g. through distal opening 809 of IMD
guiding portion 808.
[0176] FIG. 32 is an enlarged perspective view of a distal portion
of implant tool 800. Lead 706 is shown to include one or more
fixation members 770 in the embodiment shown. Fixation members 770
may freely extend through slotted distal hollow needle portion 836
of plunger 830 and open sided lumen 814 of needle guiding portion
810.
[0177] FIGS. 33a-33d show perspective views of implant tool 800
being used to deploy IMD 700 and lead 706 to a desired implant
site. In FIG. 33a, implant tool distal end 806 is advanced to a
desired implant location along tissue layer 490 by a user gripping
syringe body proximal end 804. Distal end 806 may be a dissecting
end that creates an IMD pocket through subcutaneous layers as it is
advanced to tissue layer 490.
[0178] As shown in FIG. 33b, plunger 830 is advanced through
syringe body 802 to simultaneously eject IMD 700 from IMD guiding
portion 808 (by advancing plunger mid-portion 840) and pierce
distal tip 837 of needle portion 836 through tissue layer 490 as
needle portion 836 is advanced out of needle guiding portion 810.
Distal tip 837 is advanced a maximum distance corresponding to the
distance stopping interface 834 of plunger 830 travels before
interfacing with stop surface 805 of syringe body 802. Tines 770
may flex inwardly during injection through tissue layer 490 than
expand to resist retraction of lead 706 through tissue layer
490.
[0179] Plunger 830 is withdrawn from syringe body 802 as shown in
FIG. 33c. IMD lead 706 is retained beneath tissue layer 490 by
fixation members 770. Syringe body 802 may then be withdrawn
leaving IMD 700 at a desired implant site over tissue layer 490
with tethered lead 770 extending through tissue layer 490.
Electrodes 708 (FIG. 33d) are deployed to a targeted therapy
delivery site in close proximity to a target nerve and passively
anchored by tines 770. Additional fixation techniques may be used
to anchor IMD 700 in place as described previously herein.
[0180] In this way, electrodes 708 can be positioned in close
proximity to a nerve such as the tibial nerve without having to
deliver stimulation pulses through a tissue layer such as the deep
fascia. Placement beneath the tissue layer may reduce the pulse
energy required for efficacious therapy. Only a small puncture
through the deep fascia or other superficial tissue layer is
required to position the electrodes 708 in close proximity to the
tibial nerve and by extending lead 706 through the deep fascia, IMD
700 may also be stably anchored over the deep fascia.
[0181] FIGS. 34 and 35 are perspective views of an alternative
embodiment of IMD 700 and lead 706 in which lead 706 includes one
or more distal fixation members 770 and one or more proximal
fixation members 772. As shown in FIG. 34, distal fixation members
770 may be advanced through tissue layer 490 to reduce the
likelihood of lead 706 migrating back through tissue layer 490.
Proximal fixation members 772 reduce the likelihood of lead 706
migrating deeper, i.e. advancing further through tissue layer 490.
As shown in FIG. 35, proximal fixation members 772 may extend from
lead 706 at a different angle and/or direction than distal fixation
members 770 to restrict movement of lead 706 in one direction while
distal fixation members 770 restrict movement in a different
opposite direction. It is contemplated that multiple fixation
members may extend in multiple directions from lead 706 to limit
movement of lead 706 and thereby fix lead 706 and electrodes 708 at
a desired implant location.
[0182] FIG. 36 is a side view of IMD 900 including a housing
fixation member configured as a curved barb or hook 910. Hook 910
extends between a proximal end 912 and distal free end 914.
Proximal end 912 is attached to a bottom face 904 of IMD housing
902, at or along an intersection with a side wall 906 of housing
902. Distal end 914 is a pointed or sharpened tissue-penetrating
tip. Hook 910 is positioned along housing 902 such that a side wall
906 of housing 902 can be positioned along a tissue surface, and,
upon rotation of the IMD about an intersection between side wall
906 and bottom face 904, distal end 914 penetrates tissue layer 490
as bottom face 904 is laid against tissue layer 490. In this
manner, hook 910 can be rotated into tissue layer 490.
[0183] FIG. 37 is a side view of IMD 900 after fixation against a
tissue layer 490. Fixation member distal end 914 may fully
penetrate through tissue layer 490 and curve back up through tissue
layer 490 such that end 914 exits a top surface of tissue layer
490. Alternatively, fixation member distal end 914 may remain below
or within tissue layer 490. IMD bottom face 904 is stably
positioned against tissue layer 490. Hook 910 may include barbs or
tines extending therefrom to further resist retraction of hook 910
through tissue layer 490.
[0184] IMD 900 may include a second fixation member 920 in some
embodiments. A second fixation member 920 may extend from bottom
face 904 or an IMD housing sidewall and be advanced through tissue
layer 490 as bottom face 904 is rotated down and against tissue
layer 490. In the embodiment shown, second fixation member 920 is
embodied as a flanged post, e.g. corresponding to the fixation
members 110 shown in FIGS. 3 and 4. Alternatively, a second
fixation member may correspond to any of the fixation members, or
adaptations or combinations thereof, described in conjunction with
FIGS. 9-25. Fixation member hook 910 and/or fixation member 920 may
additionally serve as or include an electrode for delivering a
neurostimulation therapy and/or sensing electrophysiological
signals.
[0185] FIG. 38 is a side view of an alternative embodiment of an
IMD 901 including fixation member hook 910. IMD 901 includes a
protruding tab 922 for facilitating a fixation member, which may be
a suture or any of the other fixation members shown and described
herein as extending through an aperture formed along a portion of
an IMD housing.
[0186] IMD 901 further includes one or more electrodes 924
positioned along bottom face 904 of IMD housing 902. Upon rotation
of IMD 901 against tissue layer 490 about an intersection between
side wall 906 and bottom face 904, hook 910 will penetrate tissue
layer 490 and anchor bottom face 904 and electrode(s) 924 against
tissue layer 490. Electrode(s) 924 are positioned to deliver
neurostimulation through tissue layer 490, to a nerve extending
beneath tissue layer 490, e.g. the tibial nerve extending beneath a
deep fascia layer. In some embodiments, hook 910 may serve as or
include an electrode. Accordingly, hook 910 and electrode 924 may
form a bipolar pair for delivering neurostimulation. Fixation of
IMD 901 and electrode placement are performed simultaneously.
[0187] FIG. 39A is a side view of an IMD 950 including one or more
electrodes 962 and 964 embodied as feedthrough pins extending from
IMD housing 952. Distal ends 963 and 965 of feedthrough pin
electrodes 962 and 964 may extend through a tissue layer 490 to
position electrodes 962 and 964 in closer proximity to a targeted
nerve. A feedthrough pin electrode 964 may extend at an acute angle
relative to a face of housing 952 to promote anchoring of the IMD
950 at the implant site. A distal end 963 of a feedthrough
electrode 962 may be enlarged or flattened to provide a greater
electrode surface area and/or a retention member to promote IMD
fixation.
[0188] A feedthrough assembly 970 is shown in FIG. 39B. Feedthrough
assembly 970 includes a flanged ferrule 972, an insulator 974, and
a feedthrough pin 976. The ferrule 972 is bonded or welded within
an aperture of the IMD housing. The insulator 974, which may be
glass, sapphire or ceramic, is bonded to ferrule 972, for example
using a glass seal, a gold braze, or a diffusion bond. An
electrically conductive feedthrough pin 976 extends through
insulator 974 and may be bonded to insulator 974 using a glass
seal, gold braze or diffusion bond or other sealed joint.
Feedthrough pin 976 may be used as a therapy delivery electrode,
eliminating additional interconnects, conductors, and electrode
components. All or a portion of feedthrough pin 976 may be coated
with an electrode surface enhancing material, such as titanium,
platinum, iridium, or alloys thereof, to increase electrode surface
area and/or enhance electrochemical stability of the electrode. The
feedthrough pin 976 may be stamped to form a flattened distal end,
e.g. nail head or paddle shaped, to increase the stimulating
surface area.
[0189] FIG. 40 is an enlarged perspective view of a feedthrough pin
980 including a stamped distal end 982 forming a "nail head"
geometry, which increases electrode surface area and may act as a
fixation member flange to promote anchoring of an associated IMD at
an implant site.
[0190] FIG. 41 is a depiction of a variety of stamped or preformed
feedthrough pins including variously shaped distal ends that may be
implemented to increase electrode surface area and/or promote
fixation of the IMD at an implant site. A looped distal end 990, a
hooked distal end 991, a triangular distal end 992, an angled
distal end 993, a helical distal end 994, and paddle shaped distal
ends 995, 996 are shown.
[0191] FIG. 42 is a perspective view of a fixation member electrode
and feedthrough assembly 1000. Assembly 1000 includes an insulated
electrical feedthrough 1001 and a fixation member 1010. Feedthrough
1001 includes a ferrule 1002 bonded to an insulator 1004 and a
feedthrough pin 1006 extending through the insulator 1004. The
ferrule 1002 is configured to be welded within an aperture of and
IMD housing.
[0192] Fixation member 1010 may be coupled to insulator 1004, e.g.
by brazing, diffusion bonding, or glass sealing methods. Fixation
member 1010 includes a flanged hollow post 1012. Feedthrough pin
1006 extends through post 1012, which may include an aperture 1015
for facilitating welding of post 1012 and feedthrough pin 1006.
Aperture 1015 may be sealed, e.g. backfilled with medical adhesive,
after welding.
[0193] Post proximal end 1014 is fixedly mounted on insulator 1004
and flanged distal end 1016 may be positioned against tissue for
delivering stimulation energy. As described previously in
conjunction with FIGS. 3 and 4, fixation member 1010 may include
sharpened puncture tip 1018 extending from flanged distal end 1016
for puncturing through a tissue layer for fixation of an associated
IMD. Flanged distal end 1016 promotes fixation of IMD when a tissue
layer is captured between flanged distal end 1016 and a face of the
IMD. Puncture tip 1018 may be a bioabsorbable or dissolvable
material as described previously herein such that it is absorbed
over time, leaving flanged post 1012 behind to serve as both a
fixation member and electrode. By electrically coupling feedthrough
pin 1006 directly to fixation member 1012, additional conductors,
interconnects and electrode components are eliminated.
[0194] FIG. 43 is a bottom perspective view of an IMD 1050
including the fixation member electrode and feedthrough assembly
1000 of FIG. 42. The assembly 1000 may be coupled to the IMD
housing 1052 by welding ferrule 1002 into an aperture formed at any
desired location along IMD housing 1052. By implementing a fixation
member electrode and feedthrough assembly 1000, manufacturing
techniques may be simplified or reduced in cost by eliminating
additional steps and components needed to separately assemble an
electrode, fixation member and feedthrough assembly.
Miniaturization and ease of use are promoted by eliminating device
components and enabling fixation and electrode placement in a
single step.
[0195] FIG. 44 is a perspective view of an implant tool 1100 for
use in a minimally invasive IMD implantation procedure. To gain
access to a targeted implant site, such as the tibial nerve, a
miniaturized IMD is advanced through a small skin incision and into
a tissue pocket, e.g. superior to the flexor retinaculum and
posterior to the medial malleolus. The target location for an IMD
with electrodes incorporated along an IMD housing may be
approximately 5 cm (or less) above the medial malleolus, with the
device adjacent to the retinaculum, providing stimulation therapy
through a deep fascia layer.
[0196] Implant tool 1100 includes a body 1102 extending between a
first end 1104 and a second end 1106. The first end 1104 is
provided with an incising blade 1108 for cutting an incision
through the skin. Incising blade 1108 may be configured as a
retractable blade or removable blade. Alternatively, a cover or
blade guard 1120 may be provided to cover and protect the blade
1108 when not in use. When configured as a retractable blade, a
slide, lever, spring or other actuating mechanism for retracting
and advancing blade 1108 may be positioned along body 1102, e.g.
near second end 1106. The blade 1108 has a width to create an
incision that is not wider than required for inserting the IMD. In
one embodiment, the blade width is provided to be approximately
equal to the incision width needed to insert the IMD.
[0197] The second end 1106 includes a blunt edge for performing
dissection down to and along a tissue plane, e.g. along the deep
fascia, for forming a tissue pocket in which an IMD will be
positioned. The tool body 1102 may include graduations, markings,
physical protrusions, stops or other features for indicating a
depth of a tissue pocket that has been created, enabling a pocket
of adequate depth and proper width to be formed for receiving the
IMD.
[0198] Tool body 1102 includes a straight portion 1103 and an
S-shaped bend 1105 as shown such that first end 1104 extends
approximately parallel to straight portion 1103. Second end 1106
extends from straight portion 1103. However it is recognized that
tool body 1102 may include one or more bends, curves or angles to
provide ergonomic, comfortable use of tool 1100 and to position
ends 1104 and 1106 at desired angles relative to tool body 1102 to
facilitate incising and dissection during an implant procedure.
[0199] In some embodiments, implant tool 1100 includes nerve
locating electrodes 1110 along a bottom surface of the tool body
1102, near the blunt, dissecting end 1106. As end 1106 is advanced
along a tissue plane, electrodes 1110 may be used to deliver test
pulses until a location is identified which results in a
satisfactory neurostimulation response. A satisfactory response to
stimulation may be identified based on a stimulation threshold, an
EMG signal, accelerometer or other motion signal, other
physiological signal or user observation.
[0200] Electrodes 1110 may be electrically coupled to an external
pulse generator via contacts 1112 positioned along tool body 1102
near first tool end 1104. Contacts 1112 may be snaps, pads or
sockets to facilitate connection of cables, e.g. with alligator
clips, extending to an external stimulation pulse generator.
Contacts 1112 may each be coupled to respective insulated
conductors extending through or along tool body 1102 to respective
electrodes 1110. Alternatively conductor wires may be incorporated
in tool 1100 and extend away from tool 1100 for connecting to a
pulse generator.
[0201] Electrodes 1110 may be positioned a distance from end 1106
and sized and spaced from each other to correspond to electrodes
along an IMD housing or IMD lead such that stimulation testing can
be performed in a manner that simulates stimulation energy being
delivered by the IMD electrodes or lead electrodes that will be
used in the implanted system. While only two electrodes 1110 are
shown, it is recognized that multiple electrodes 1110 may be
provided along tool body 1102, with a corresponding number of
connectors 1112, to enable testing of multiple electrode
combinations and electrode locations without having to reposition
tool 1100.
[0202] Once an optimal implant location is identified based on
measured or observed responses to test stimulation pulses, tool
1100 may be removed and an IMD is inserted into the created tissue
pocket at the identified depth using a delivery tool.
Alternatively, tool 1100 may be left in place as a guide for
inserting and locating the IMD at the desired implant site.
[0203] FIG. 45 is a perspective view of an alternative embodiment
of an implant tool 1200. Tool 1200 includes a tool body 1202
extending between a first end 1204 and a second end 1206. First end
1204 includes an incising blade 1208, which may be retractable,
removable, or covered by a blade guard as described above, and is
used for creating a minimally sized skin incision for implanting an
IMD. Second end 1206 includes a blunt dissecting edge for advancing
through tissue and creating a tissue pocket along a desired tissue
layer. While not shown in FIG. 45, tool 1200 may additionally
include electrodes and associated connectors for nerve location and
graduations or other markings or features for identifying a depth
of a created tissue pocket.
[0204] First end 1204 is shown angled approximately ninety degrees
from tool body 1202 and second end 1206 is shown angled
approximately forty-five degrees from tool body 1202. As described
above, numerous configurations of tool body 1202 may be conceived
which provide comfortable handling of tool 1200 and facilitate
tissue pocket creation at a desired IMD implant site. For example,
ease of use and access to a desired implant site may be promoted by
implementing particular relative angles between opposing dissecting
and incising ends, relative to each other or to a central tool body
extending there between. In some embodiments, the shape of tool
body 1202 is adjustable, e.g. when formed of a malleable
material.
[0205] FIG. 46 is a flow chart 1300 of a method for delivering a
neurostimulation therapy according to one embodiment. An optional
initial step is performed at block 1301 to locate or visualize a
targeted nerve, such as the tibial nerve. The location of the
tibial nerve, for example, may be performed using ultrasound,
external skin electrodes, or other imaging or stimulating
techniques. Visualization or localization of the tibial nerve, or
another targeted neural site, as an initial step can be used to
guide a clinician in selecting an incision site.
[0206] At block 1302, a skin incision is created. A skin incision
may be created using a standard scalpel or an incising edge or
blade of an implant tool as described above, for example in
conjunction with FIGS. 44 and 45. The skin incision is minimized in
size to accommodate a miniaturized IMD. For example the length of
the skin incision may be made approximately equal to a width of an
incising end of an implant tool to provide an incision just large
enough for insertion of an IMD or an IMD delivery tool.
[0207] At block 1304, a tissue pocket is formed for receiving the
IMD along a tissue plane at a desired implant site. The tissue
pocket may be dissected using a dissecting end of implant tool as
described in conjunction with FIGS. 44 and 45. Using an
appropriately sized tool, the pocket is formed to be just large
enough to receive the IMD (or a delivery tool used to deploy the
IMD). The tissue pocket is formed along a superficial surface of a
tissue layer, for example a superficial surface of the deep fascia
that is superficial to a targeted nerve, for positioning the IMD
along the superficial surface.
[0208] An optimal stimulation location may be identified at block
1306 prior to deploying the IMD. Electrodes included on an implant
tool or on an IMD delivery tool advanced into the created pocket
may be used to identify the optimal stimulation location by
delivering test stimulation pulses and measuring and/or observing a
stimulation response. In some embodiments, electrodes included on
the IMD housing or a lead coupled to the IMD may be exposed through
an IMD delivery tool and can be used for delivering test pulses
from the IMD to test different IMD locations prior to fixing the
IMD at an implant site.
[0209] Once an optimal implant location is identified, the IMD is
delivered to the implant site at block 1308. The IMD may be
delivered to the implant site using a delivery tool as described
herein to simultaneously deliver the IMD and deploy a fixation
member to anchor the IMD at the implant site. Alternatively, a
fixation member may be deployed in a separate step after
positioning the IMD, which may include verifying efficacious
stimulation by the IMD prior to fixation. Fixation of the IMD may
include the use of passive and/or active fixation members, such as
tines or other passive fixation members extending from the IMD
housing and/or from an electrical lead extending from the IMD. In
some examples, an IMD incorporating electrodes along the IMD
housing is positioned along the superficial tissue surface and
passively fixated by tines or other passive fixation members
extending from the IMD housing. In other examples, an IMD
incorporating electrodes along the IMD housing and/or incorporated
in active housing fixation members is positioned along the
superficial surface of the tissue layer and the active housing
fixation members extend into the tissue layer. An active fixation
member may extend into the tissue layer that is superficial to the
targeted nerve to capture the tissue layer between a portion of the
active fixation member and the IMD housing. In some embodiments
described herein, an active fixation member extends through an
aperture of the IMD housing. Any of the fixation techniques
described herein may be used to anchor the IMD at a desired
site.
[0210] In still other examples, delivering the IMD to the implant
site may include concomitantly delivering a lead coupled to the
IMD. The lead may extend along the superficial surface of the
tissue layer or be inserted into the tissue layer to both fix the
IMD at the therapy delivery site and position electrodes carried by
the lead near the targeted nerve.
[0211] In various embodiments, electrodes for delivering
neurostimulation energy may be carried along the IMD housing,
incorporated in or along a fixation member, and/or carried by a
lead extending from the IMD. Delivery of the IMD system and
fixation of the IMD system can be performed simultaneously in a
single step. After implanting and fixating the IMD system, the skin
incision is closed.
[0212] At block 1310, the IMD is enabled to deliver a
neurostimulation therapy according to a prescribed protocol.
Depending on the particular IMD configuration being used, the
neurostimulation therapy is delivered through a tissue layer, e.g.
through a deep fascia layer, using electrodes positioned above
(superficially to) the tissue layer to stimulate a relatively
deeper nerve extending beneath the tissue layer. In one embodiment,
the tibial nerve is stimulated through the deep fascia tissue layer
by wholly implanted electrodes positioned superficially to the deep
fascia, i.e. on the opposing side of the deep fascia, from the
nerve and superior to the flexor retinaculum. In other embodiments,
electrodes may be positioned in close proximity to a targeted nerve
by advancing the electrodes, which may additionally be configured
as fixation members as described herein, through an overlying
tissue layer, e.g. a deep fascia layer.
[0213] Thus, various embodiments of a minimally invasive IMD system
have been presented in the foregoing description with reference to
specific embodiments, as well as methods for implanting and
securing the same. The various features of IMD fixation members and
implant tools and associated methods of use described herein may be
implemented in any combination other than the particular
combinations shown in the illustrative embodiments, which may
include adding or omitting some features. It is appreciated that
various modifications to the referenced embodiments may be made
without departing from the scope of the disclosure as set forth in
the following claims.
* * * * *