U.S. patent application number 16/117118 was filed with the patent office on 2019-05-09 for secured and self contained spinal cord stimulator leads and catheters.
The applicant listed for this patent is SPINELOOP, LLC. Invention is credited to Abdullah Kaki, John Koelsch, Ashraf Taha.
Application Number | 20190134347 16/117118 |
Document ID | / |
Family ID | 52744696 |
Filed Date | 2019-05-09 |
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United States Patent
Application |
20190134347 |
Kind Code |
A1 |
Taha; Ashraf ; et
al. |
May 9, 2019 |
SECURED AND SELF CONTAINED SPINAL CORD STIMULATOR LEADS AND
CATHETERS
Abstract
A stimulator lead is herein disclosed. The stimulator lead
includes a proximal portion that is configured for placement
external the epidural space through a first opening, wherein said
proximal portion is operatively connected to an IPG unit, a distal
portion that is configured for placement external the epidural
space through a second opening, and a third portion between the
proximal and distal portions that is configured for percutaneous
placement in an epidural space, wherein said middle portion
includes at least one stimulator electrode for placement adjacent
to target dura.
Inventors: |
Taha; Ashraf; (Irvine,
CA) ; Kaki; Abdullah; (Jeddah, SA) ; Koelsch;
John; (Capistrano Beach, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SPINELOOP, LLC |
Newport Beach |
CA |
US |
|
|
Family ID: |
52744696 |
Appl. No.: |
16/117118 |
Filed: |
August 30, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14494906 |
Sep 24, 2014 |
10105513 |
|
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16117118 |
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62017156 |
Jun 25, 2014 |
|
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61881924 |
Sep 24, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0043 20130101;
A61M 25/0026 20130101; A61N 1/0553 20130101; A61N 1/36071 20130101;
A61M 2025/0057 20130101; A61M 2025/0007 20130101; A61N 1/0558
20130101; A61M 5/14 20130101; A61M 25/007 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61N 1/05 20060101 A61N001/05; A61M 5/14 20060101
A61M005/14; A61N 1/36 20060101 A61N001/36 |
Claims
1-20. (canceled)
21. A spinal cord stimulator comprising: a proximal end and a
distal end, wherein each end comprises an anchoring device adapted
to anchor the spinal cord stimulator within the epidural space; a
circuit board; a battery; a pulse generating unit comprising one or
more electrodes, wherein the pulse generating unit is operably
connected to the battery and the circuit board, and is configured
to deliver an electrical pulse through the one or more electrodes;
wherein the spinal cord stimulator is configured to be implanted
entirely within the epidural space of a human.
22. The spinal cord stimulator of claim 21, wherein the circuit
board is adapted to be programmed wirelessly.
23. The spinal cord stimulator of claim 21, wherein the battery is
adapted for wireless charging.
24. The spinal cord stimulator of claim 21, wherein the pulse
generating unit comprises a single electrode wire.
25. The spinal cord stimulator of claim 21, wherein the pulse
generating unit comprises a plurality of electrodes.
26. The spinal cord stimulator of claim 21, wherein the pulse
generating unit is configured to control at least one of a
frequency and an amplitude of the electrical pulse.
27. The spinal cord stimulator of claim 21, wherein the pulse
generating unit is configured to control a frequency and an
amplitude of the electrical pulse.
28. The spinal cord stimulator of claim 21, wherein the pulse
generating unit is configured to independently control a plurality
of electrodes.
29. The spinal cord stimulator of claim 28, wherein the pulse
generating unit is configured to control at least one of a
frequency and an amplitude of the electrical pulse at each of the
independently-controlled electrode.
30. The spinal cord stimulator of claim 28, wherein the pulse
generating unit is configured to control a frequency and an
amplitude of the electrical pulse at each of the
independently-controlled electrodes.
31. The spinal cord stimulator of claim 21, wherein the anchoring
device comprises a suture, a button, or a wire.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 14/494,906, filed Sep. 24, 2014, which
claims the benefit of U.S. Provisional Application Nos. 61/881,924,
filed Sep. 24, 2013, and 62/017,156, filed Jun. 25, 2014.
BACKGROUND OF THE INVENTION
Technical Field
[0002] The disclosed technology relates generally to medical
devices, and more particularly, some embodiments relate to
neuromodulation and implantable medical devices that provide
proximal and distal stability to a stimulator lead, pain pump,
and/or other similar medical devices that may be placed in the
epidural space.
Description of the Related Art
[0003] Spinal stimulation has been in practice as a means of pain
control for patients after the gate theory was proposed in 1965 by
Melzack and Wall. Spinal cord stimulation through implantable means
was performed by Shealy et al. for the treatment of chronic pain
where the first spinal cord stimulator was placed within the dorsal
column for treatment of chronic pain shortly after the discovery of
Melzack and Wall.
[0004] Traditionally, a spinal cord stimulation lead typically
comes in two types of leads. The first, is a wire-like lead with
leads that are placed at the end of the wire, i.e., the distal end.
A second type of spinal cord stimulator lead is a surgical lead or
a paddle lead that typically has a wider area of stimulation. This
second type of spinal cord stimulator lead is generally inserted
under surgical technique and may require partial laminotomy to be
performed (also known as a paddle lead), and also has its
stimulation portion or site at the distal end of the wire or paddle
where the first part of the leads would be considered the proximal
end.
[0005] In providing analgesic relief to patients with pain, spinal
cord stimulator leads may provide electrical stimulation using an
electric pulse generator that may be connected to conducting wires
that subsequently connect or reach the distal portion of the wire
where either the leads of the wire or the leads of the paddle are
located. Thus, when stimulated, the leads adjacent to the spinal
cord dura would provide stimulation that will help alleviate pain.
With either percutaneous or surgically implanted stimulator leads,
the current practice allows control from only the proximal end of
the stimulator leads. This makes it very difficult for the
practitioner to accurately position the stimulator lead in the
correct location in the epidural space in order to provide
appropriate pain relief. Insertion of the stimulator lead may
traverse many levels of the spine and the only control to date is
from the proximal end (end closest to practitioner from where it is
inserted in the body). In standard practice today, conventional
stimulator leads have no control mechanism where the practitioner
may control the distal end of the lead (the portion furthest away
from the point of entry of the body as well as the practitioner).
Having only one entry point and one point of control makes not only
navigation difficult for spinal cord stimulation, but also leads to
other issues such as lead migration and lead retrieval issues if
the leads break while inside the body.
BRIEF SUMMARY OF THE INVENTION
[0006] The technology disclosed herein relates to a neuromodulation
and implantable medical device that provides distal and proximal
stability to a spinal cord stimulator lead that may be placed in
the epidural space of the spine by percutaneous techniques thereby
eliminating some of the most common causes of spinal cord treatment
failure. There are a plurality of different exemplary models herein
disclosed, each embodiment directed at a different innovative
concept. By way of example, one embodiment may have a distal and a
proximal end exiting the spinal cord and patient's body, wherein
the middle portion of the stimulator lead is placed within the
epidural space of the spine laying adjacent the targeted area of
the dura or exiting nerves of the spinal cord. In this embodiment,
the practitioner may secure the proximal and distal ends outside
the epidural space and thus firmly control the placement of the
middle portion of the dual input, dual source (DIDS) spinal cord
stimulator lead.
[0007] The DIDS spinal cord stimulator lead may be placed into an
epidural space using a percutaneous technique where it may be
placed at any level of the spinal cord. It may be utilized to
relieve, for example, chronic pain, radiculopathies, intractable
pain and so forth. The DIDS spinal cord stimulator lead may also be
configured to reduce or even eliminate lead migration seen in most
conventional stimulators leads. This can be accomplished, for
example, by securing its two ends (proximal and distal) outside the
epidural space where the middle portion of the dual source dual
input spinal cord DIDS stimulator lead may not move out of place;
effectively eliminating lead migration issues as compared to
conventional stimulator leads.
[0008] One aspect of an example spinal cord stimulator lead is
disclosed. in some embodiments, a spinal cord stimulator includes a
proximal portion that is configured for placement external the
human anatomy through a first opening, wherein said proximal
portion is operatively connected to an IPG unit, a distal portion
that is configured for placement external the human anatomy through
a second opening, and a middle portion that is configured for
percutaneous placement in an epidural space, wherein said middle
portion includes at least one stimulator electrode for placement
adjacent to target dura.
[0009] One aspect of the DIDS spinal cord stimulator lead is
disclosed. The advantages of the DIDS spinal cord stimulator lead
that may be obtained in various embodiments can include resolving
the issues associated with lead migration. Through percutaneous
means, and using the technique as referenced above, embodiments can
be implemented in which the practitioner may be afforded control of
the entire length of the spinal cord stimulator lead. This is an
advancement over the time tested Seldinger Technique catheter over
wire procedure. Traditional stimulators only allow for one end of
control allowing the distal end to be mobile. By securing both
ends, the DIDS spinal cord stimulator lead corrects this issue
simply without the need of added complexity and danger to the
patient.
[0010] Additionally, having two ports of access allows for two IPG
(implantable pulse generator) units attached to either ends
(proximal or distal) of the spinal cord stimulator lead. The IPG
units at either the proximal or distal ends in the DIDS spinal cord
stimulator lead are outside the spinal canal and epidural space.
The DIDS IPG units have many advantages as compared to traditional
one IPG unit stimulators and leads. The battery for the IPG units
can be smaller thus allowing for placement and retrieval by
percutaneous means rather than a pocket surgery typically needed
for traditional stimulators that require larger battery types. The
distal and proximal ends can be configured with removable and
replaceable IPG units. This will allow practitioners, at a later
date, the ability to change or replace the IPG units with units
that provide higher, lower or stronger pulses or frequencies. This
also allows for easy removal of the internal hardware and software
if an update, change or replacement is needed. The middle portion
of the spinal cord stimulator DIDS spinal cord stimulator lead
provides the circuitry and stimulation electrode points where
electrical charge can be provided to the target areas along the
Dura for pain relief.
[0011] In another iteration of the DIDS spinal cord stimulator
lead, the EDIDS (Expandable dual input, dual source) spinal cord
stimulator lead has a middle portion that is expandable which
allows for easier displacement as well as larger surface area
coverage for electrode stimulation points. Additionally, the MDIDS
(Multi channel dual input dual source) spinal cord stimulator lead
provides the added benefit possessing one or two drug pumps. The
MDIDS will be able to provide disbursement of medications in the
form of liquids, gases, solids and powders that will be easily be
placed in the epidural space and potentially the dura itself
through a porous lumen which will be connected to either a drug
pump or IPG unit on either side of the spinal cord stimulator lead.
The MDIDS may also have drug pump capabilities as well as spinal
cord simulator capabilities in the same lead that may allow for
pain relief that can be accomplished through chemical as well as
gait theory distraction stimulation. These capabilities provide
practitioner with a more advanced tool to be able to offer greater
relief to the patient. The distal and proximal end of the MDIDS
spinal cord stimulator lead may have either a pain pump and or an
IPG unit at either end. The two ports allow for a proximal and or
distal drug pump that solves a number of issues through redundancy.
If one port becomes clogged the other port will be continue to
function. This redundancy allows for continuous medication and can
help prevent a disastrous event if one port becomes clogged.
[0012] The Dual Port Catheter Drug Pump Delivery System may be
placed and secured within the epidural space along any desired
target area of the dura of the spinal cord within the patient's
spine canal. The Dual Port Catheter Drug Pump Delivery System
DPCDPD allows for drug delivery using two ports of access that is
independent of the MDIDS lead, which possess combined drug pump and
spinal cord stimulator capabilities.
[0013] Additionally, the disclosure herein describes a Self
Contained Spinal Cord Stimulator SCSCS where the SCSCS is a lead
which may be used to house the software, hardware, computing
capabilities, IPG unit, Battery source, stimulator electrodes,
circuitry (including flexible circuit boards), connecting wires
needed to propagate a charge. The SCSCS proximal end and a distal
end may be used to anchor via suture, button, wire mechanism or
other fixation mechanism readily known in the art for stability
within the epidural space or outside the epidural space, however
the practitioner sees fit. The SCSCS possess within its elongate
body the ability to compute, transfer data and generate a
stimulation pulse without need of an IPG unit outside the epidural
space as compared to traditional spinal cord stimulator leads.
[0014] The SCSCS lead contains all structures necessary to provide
propagation of current and stimulation of the targeted dura.
Additionally, the SCSCS is capable to receive and send information
in and out of the patient's body without hard wire interface. The
computer capability and firmware/software aspects may be completely
housed within the SCSCS within the epidural space. The spinal cord
stimulator may have wireless capabilities. Wireless communication
may be any one of the applicable standards or a custom protocol
including WiFi (802.11a/b/g/n), Bluetooth.RTM., Zigbee.RTM., or a
custom protocol over the dedicated medical body-area network within
the FCC assigned spectrum. In so doing, the patient or practitioner
will be able to program or control the SCSCS from outsides the
patient's body. Power to the stimulate unit may be provided by way
of a battery that may be inside the epidural space, completely
enclosed within the lead itself or partially exposed for ease of
exchange. Computer processing may be based on an FPGA, ASIC, hybrid
analog-digital ASIC, or general-purpose processor. The SCSCS IPG
unit may also traverse the entire length of the spinal cord
stimulator and may be comprised of flexible circuits or
miniaturized. The SCSCS may be able to charge its battery through
wireless technology where a transmitter will be on the outside of
the patient's body and able to recharge the battery within the
patient's body without direct contact, e.g., by induction.
[0015] The plurality of spinal stimulators leads discussed possess
the ability to share information, current and functionality within
the epidural space through connection ports side-by-side with other
stimulators. This allows for shared current and shared information
where the devices can work in conjunction with each other spinal
cord stimulators to allow for greater surface area and greater pain
relief. The plurality of discussed spinal cord stimulator leads
possess malleable qualities that allow for flexion and extension
that is compatible with the movement within the epidural space.
Additionally, the embodiments of the technology disclosed herein
possess the ability to vibrate at desired frequencies.
[0016] Another aspect of a spinal cord stimulator lead is
disclosed. A spinal cord stimulator lead includes a proximal
portion that is configured for placement within the human anatomy
at a first location, a distal portion that is configured for
placement within the human anatomy at a second location, and a
middle portion that is configured for percutaneous placement in an
epidural space, wherein said middle portion includes at least one
stimulator electrode for placement adjacent to target dura.
[0017] An aspect of an electrical stimulator lead is also
disclosed. An electrical stimulator lead includes a self-contained
elongate that is configured to be percutaneously inserted into the
human anatomy, wherein said self-contained elongate further
comprises, a proximal portion that is configured for placement
within the human anatomy at a first location, a distal portion that
is configured for placement within the human anatomy at a second
location, and a middle portion that is configured for percutaneous
placement near a target treatment area, wherein said middle portion
includes at least one stimulator electrode.
[0018] Various embodiments may be implemented in which the
practitioner has access to both distal and proximal ends as
described, this allows anchoring of the proximal and/or distal
segments of the stimulator, thus eliminating or minimizing issues
with lead migration. Additionally, other embodiments disclosed
herein include drug pump capabilities and a stimulator lead that
may contain all the necessary components to provide user
interaction and propagation of pulse energy for pain relief with
contact outside the epidural space and the spinal canal. The
embodiments described may be placed at any level of the spinal
cord.
[0019] It is understood that other aspects of the technology
disclosed herein may become readily apparent to those of ordinary
skill in the art from the following detailed description, wherein
it is shown and described only various aspects of the invention by
way of illustration. As will be realized, the invention is capable
of other and different configurations and its several details are
capable of modification in various other respects, all without
departing from the scope of the invention. Accordingly, the
drawings and detailed description are to be regarded as
illustrative in nature and not as restrictive.
BRIEF DESCRIPTION OF DRAWINGS
[0020] Various aspects of the illustrative embodiments will be
described herein using terms commonly employed by those skilled in
the art to convey the substance of their work to others skilled in
the art. However, it will be apparent to those skilled in the art
that the embodiments of the technology disclosed herein may be
practiced with only some of the described aspects. For purposes of
explanation, specific numbers, materials and configurations are set
forth in order to provide a thorough understanding of the
illustrative embodiments. However, it will be apparent to one
skilled in the art that the disclosed technology may be practiced
without the specific details. In other instances, well-known
features are omitted or simplified in order not to obscure the
illustrative embodiments.
[0021] FIGS. 1-5 (prior art) illustrate various conventional spinal
cord stimulator leads implanted in an epidural space.
[0022] FIG. 6 is a top view of a dual input, dual source spinal
cord lead (DIDS).
[0023] FIG. 7 is a view of the expandable dual input, dual source
spinal cord lead (EDIDS).
[0024] FIG. 8 is a perspective view demonstrating on a spine model
the dual input dual source spinal cord stimulator lead DIDS in the
epidural space.
[0025] FIG. 9 is a perspective view of the expandable dual input,
dual source spinal cord lead (EDIDS) in the epidural space.
[0026] FIG. 10 is a perspective view of the Multi-channel dual
input dual source (MDIDS) spinal cord stimulator lead and catheter
in the epidural space with a parallel lumen having apertures.
[0027] FIG. 11 is a schematic representation of two dual input dual
channel spinal cord stimulator leads DIDS connected to each
other.
[0028] FIG. 12 is a schematic representation of the Self Contained
Spinal Cord Stimulator (SCSCS).
[0029] FIG. 13 is a perspective view of the Dual Port Catheter Drug
Pump Delivery system (DPCDPD) having a lumen with a plurality of
apertures.
[0030] FIG. 14 is a perspective view of the Dual Port Cather Drug
Pump Delivery system (DPCDPD) of FIG. 13, wherein the DPCDPD is
depicted within the epidural space.
DETAILED DESCRIPTION
[0031] FIGS. 1 and 2 (prior art) illustrate conventional spinal
cord stimulator leads. FIG. 1 is a top view of a conventional
spinal cord stimulator lead. The distal end 2 of the conventional
spinal cord stimulator may be placed in the epidural space (not
shown). The distal end 2 of the conventional spinal cord stimulator
lead may contain electrodes in the form of a paddle, represented in
FIG. 2 as the distal stimulator electrodes or DSE 3. The distal
stimulator electrodes (DSE) 3 may vary in number typically 4, 8,
16, 32 or more. In FIG. 1, the distal stimulator electrodes (DSE) 3
are depicted as eight DSE at the distal end 2. The distal end 2
containing the DSE 3 may be placed above the desired target area of
the dura (not shown) of the spinal cord where the DSE 3 may
stimulate the dura of the spinal cord (not shown). In a
conventional spinal cord stimulator lead, the distal end 2 and the
distal stimulator electrodes DSE 3 enter the epidural space (not
shown) from a point lower in the spinal cord (not shown) and never
exits the epidural space. The middle portion 1 of the conventional
spinal cord stimulator lead connects the distal end 2 (that remains
inside the patient) and the proximal end 15 (that enters and exits
the patient). The practitioner placing the conventional spinal cord
stimulator lead inside the patient in the epidural space of the
spine only has control of the proximal end 15 of the conventional
spinal cord stimulator. The practitioner placing the conventional
spinal cord stimulator lead may only control the distal end 2 of
the traditional spinal cord stimulator by manipulating the proximal
end 15. The proximal end 15 of a conventional spinal cord
stimulator lead may be attached to an IPG (pulse generating device)
unit and/or battery unit (outside the epidural space). The distal
end 2 enters the epidural space at the same point where the
proximal end 15 exits from.
[0032] FIG. 2 is one view of a surgical spinal cord stimulator
lead, the distal end 2 of the surgical spinal cord stimulator lead
may be placed in the epidural space (not shown) typically by
surgical open technique that may require partial laminotomy. The
distal end 2 of the surgical spinal cord stimulator lead contains
electrodes in the form of a paddle, represented in FIG. 2 as the
distal stimulator electrodes (DSE) 3, the DSE may vary in number
typically 4, 8, 16, 32 or more. In FIG. 2, the distal stimulator
electrodes 3 number sixteen. The distal end 2 containing the distal
stimulator electrodes 3 may lie above the desired target area of
the dura of the spinal cord where the distal stimulator electrodes
DSE 3 may stimulate the dura of the spinal cord (not shown). In a
surgical spinal cord stimulator lead, the distal end 2 and the
distal stimulator electrodes DSE 3 enter the epidural space (not
shown) from a point lower in the spinal cord and never exits the
epidural space. The middle portion 1 of the surgical spinal cord
stimulator lead connects the distal end 2 (that remains inside the
patient) and the proximal end 15 (that enters and exits the
patient). The practitioner placing the surgical spinal cord
stimulator lead inside the patient in the epidural space of the
spine only has control of the proximal end 15 of the surgical
spinal cord stimulator. The practitioner placing the surgical
spinal cord stimulator lead may only control the distal end 2 of
the surgical spinal cord stimulator lead by manipulating the
proximal end 15. The proximal end 15 of a surgical spinal cord
stimulator lead may be attached to an IPG (pulse generating device
not shown) unit or battery unit (not shown) outside the epidural
space. The distal end 2 enters the epidural space (not shown) at
the same point where the proximal end 15 exits.
[0033] FIG. 3 is a front view of a normal human spine. In the front
and side views of a the human spine there are 7 cervical vertebrae
(C1, C2, C3, C4, C5, C6, C7), 12 thoracic vertebra (TI, T2, T3, T4,
T5, T6, T7, T8, T9, T10, T11, T12), lumbar vertebrae (L1, L2, L3,
L4. L5) and Sacral and Coccyx bones. FIG. 3 is a schematic
representation of six vertebrae in continuity with each other. The
six vertebrae, vertebra 1 (V1), vertebra 2 (V2), vertebra 3 (V3),
vertebra 4 (V4), vertebra 5 (V5) and vertebra 6 (V6) may represent
any six continuous vertebrae of the spine. In one example of how
FIG. 3 may schematically demonstrate a portion of the posterior
aspect of the spine, V1 may represent C1 (cervical vertebra 1) and
V2 may represent C2 (cervical vertebra 2), V3 may represent C3, V4
may represent C4, V5 may represent C5 and V6 may represent C6. In
another example of how FIG. 3 may schematically demonstrate a
portion of the spine, V1 may represent T12 (thoracic vertebra 12)
and V2 may represent L1 (lumbar vertebra 1), V3 may represent L2
(lumbar vertebra 2), V4 may represent L3 (lumbar vertebra 3), V5
may represent L4 (lumbar vertebra 4) and V6 may represent L5
(lumbar vertebra 5).
[0034] FIG. 3 illustrates the posterior aspect of a spine depicting
six vertebra along the spine. The posterior aspect of each vertebra
respectfully consists of a left transverse process (a), left lamina
(LL), spinous process (b), right lamina (RL) and right transverse
process (c). The potential space of the epidural space may be
described by its adjacent vertebral anatomy where the epidural
space between V1 and V2 may be labeled E1, 2. The epidural space
between V2 and V3 may be labeled E2, 3. The epidural space between
V3 and V4 may be labeled E3, 4. The epidural space between V4 and
V5 may be E4, 5. The epidural space between the V5 and V6 may be
E5, 6.
[0035] FIG. 4 demonstrates a conventional spinal cord stimulator in
the epidural space placed by percutaneous means. The distal end 2
and the distal stimulator electrodes DSE 3 are within the epidural
space lying superior to the spinal cord and directly below V1 and
V2. The conventional spinal cord stimulator may be seen as entering
the epidural space at an entrance point 14 and seen traversing up
the spine. The conventional spinal cord stimulator may be seen
having a proximal portion 15 that enters the epidural space at
entrance point 14 between V5 and V6. The middle portion 1 of the
conventional spinal cord stimulator connects the distal end 2 that
remains inside the patient and the proximal end 15 that enters and
exits the patient at entrance point 14. The proximal portion 15 may
be the only part of the conventional spinal cord stimulator that
remains outside the patient's body. The conventional spinal cord
stimulator distal portion 2, distal stimulating electrodes DSE 3,
the middle portion 1 all remain inside the patient's body within
the epidural space. The proximal portion 15 may be seen here
connecting to an IPG (implantable pulse generator) unit 16 outside
of the patient's spine.
[0036] FIG. 5 demonstrates a surgical spinal cord stimulator in the
epidural space placed by surgical open technique that may require
partial laminotomy. The distal end 2 and the distal stimulator
electrodes DSE 3 are within the epidural space lying superior to
the spinal cord and directly below V1 and V2. The surgical spinal
cord stimulator may be seen as entering the epidural space at an
entrance point 14 and seen traversing up the spine. The surgical
spinal cord stimulator may be seen having a proximal portion 15
that enters the epidural space at entrance point 14 between V5 and
V6. The middle portion 1 of the surgical spinal cord stimulator
connects the distal end 2 that remains inside the patient and the
proximal end 15 that enters and exits the patient at entrance point
14. The proximal portion 15 may be the only part of the surgical
spinal cord stimulator that remains outside the patient's body. The
surgical spinal cord stimulator distal portion 2, distal
stimulating electrodes DSE 3, the middle portion 1 all remain
inside the patient's body within the epidural space. The proximal
portion 15 may be seen here connecting to an IPG (implantable pulse
generator) unit 16 outside of the patient's spine.
[0037] The various embodiments disclosed herein may be implemented
using the techniques disclosed in PERCUTANEOUS METHODS FOR SPINAL
STENOSIS AND FORAMINAL STENOSIS, for which a U.S. utility patent
application was filed on Jul. 17, 2012, under Ser. No. 13/551,166,
and a PCT application was filed on Jul. 17, 2012, under Serial No.
PCT/US12/47050. The surgical techniques and apparatuses described
therein may also be referred to herein as the "T-Technique."
[0038] In a first exemplary embodiment, FIG. 6 is a top view of a
dual input, dual source spinal cord lead (DIDS) 60. The dual input
dual source spinal cord stimulator lead 60 has a proximal part 69
that may connect to a proximal IPG unit 66b and distal part 64 that
connects to a distal IPG unit 66a. The dual input, dual source
spinal cord lead 60 has both its distal part 64 and proximal part
69 outside the patient's body (not shown). The middle stimulator
paddle portion 66 contains the middle stimulator electrodes MSE 68,
which may vary in number but typically 4, 8, 16, 32 or more. As
depicted in FIG. 6, the middle stimulator electrodes MSE 68 number
eight and are represented by eight circle like figures. The middle
portion 62 is composed of the distal middle portion 65, the
proximal middle portion 67 and the middle stimulator paddle portion
66 with middle stimulator electrodes MSE 68. The middle portion 62
of the dual input, dual source spinal cord stimulator lead 60
resides completely within the patient's body (not shown). The
middle portion 62 of the dual input dual source spinal cord
stimulator lead DIDS 60 may be entered into the epidural space (not
shown) of the spinal cord (not shown) by percutaneous epidural
needles using the percutaneous technique previously discussed. The
middle portion 62 of the dual input dual source spinal cord
stimulator DIDS 60 may be controlled outside the patient's body by
a practitioner by manipulating the distal end 64 and/or the
proximal end 69. The practitioner having control of both the distal
end 64 and proximal end 69 with middle portion 62 within the body
thus has the ability to control the middle portion 62 by pulling
the distal end 64 or proximal end 69 in a backward or forward
motion, as needed. As the practitioner may be able to control the
distal portion 64 and proximal portion 69 of the dual input dual
source spinal cord stimulator lead 60, the practitioner also has
control of the middle portion 62 where the middle stimulator paddle
portion 66 and the middle stimulator electrodes MSE 68 may then be
maneuvered by pulling or pushing motion described above to the
desired target area of the dura of the spinal cord (not shown)
where the middle stimulator paddle portion 66 and the middle
stimulator electrodes MSE 68 may stimulate the targeted area
overlaying the dura of the spinal cord (not shown).
[0039] The dual port dual source spinal cord stimulator lead DIDS
60 has a distal end 64 and proximal end 69 that may be outside the
patient's body (not shown). The distal end 64 and the proximal end
69 may have many functions including the above described control of
the middle portion 62 of the dual input dual source spinal cord
stimulator lead DIDS 60. Furthermore, the distal end 64 may connect
to an IPG unit 66a and the proximal end 69 may connect to an IPG
unit 66b. Additionally, the distal end 64 and proximal end 69 may
be connected to each other to form a ring (not shown) outside the
patient. Also, the distal end 64 and the proximal end 69 may be
secured in a way outside the epidural space (not shown) that will
prevent the middle portion 62 of the dual port dual source spinal
cord stimulator lead DIDS 60 from migrating from targeted area of
dura of the spinal cord in the epidural space of the spine (not
shown). By securing the distal portion 64 and the proximal portion
69 using well-known anchoring methods outside the epidural space
and with the middle portion 62 now fixed in a desired location in
the epidural space, with the middle stimulator paddle portion 66
and the middle stimulator electrodes MSE 68 immobile and locked in
a targeted area of dura of the spinal cord, the practitioner may
effectively prevent the issue of migration of paddles and thus
eliminate the issue of lead migration seen in conventional spinal
cord stimulator leads or surgical stimulator leads (FIGS. 1-5).
[0040] By way of non-limiting examples, the benefit of having two
IPG units (distal IPG 66a and proximal IPG 66b) gives the patient
and practitioner added advantage of extended battery life, and
smaller IPG units as compared to traditional one port stimulators
(conventional percutaneous and surgical spinal cord stimulator
leads). The IPG units 66b, 66a may have different frequency output
where one IPG unit may be of high frequency and the other IPG unit
may be of low frequency. The IPG units may have different polarity
where one IPG unit 66b may be negative and the other IPG unit 66a
may be positive.
[0041] FIG. 7 is a view of the expandable dual input, dual source
spinal cord lead EDIDS 70. The expandable dual input dual source
spinal cord stimulator lead EDIDS 70 has a proximal part 79 that
connects to a proximal IPG unit 72 and distal part 74 that connects
to a distal IPG 72a. The expandable dual input dual source spinal
cord lead EDIDS has both its distal part 74 and proximal part 79
outside the patient's body (not shown). The middle stimulator
paddle portion 76 that contains the middle stimulator electrodes
MSE 78, may vary in number typically 4, 8, 16, 32 or more. In FIG.
7, the middle stimulator electrodes MSE 78 number twenty-two. The
middle stimulator paddle portion 76 of the expandable dual input,
dual source spinal cord stimulator lead EDIDS 70 has many functions
and expandable capabilities. The middle stimulator paddle portion
76 initially may be folded or rolled up upon itself and once inside
the epidural space may expand by electronic, magnetic, pressure,
memory form metals and alloys, nanotechnology, graphene components,
hydraulics and/or mechanical means. The middle stimulator paddle
portion 76 has ability to contract back to initial size and fold up
or roll upon itself if the practitioner wishes to remove the
expandable dual input dual source spinal cord lead EDIDS 70 at a
later date.
[0042] The middle portion 71 may be composed of the distal middle
portion 75, the proximal middle portion 77 and the middle
stimulator paddle portion 76 with middle stimulator electrodes MSE
78. The middle portion 71 of the expandable dual input, dual source
spinal cord stimulator EDIDS lead 70 may reside completely within
the patient's body (not shown). Additionally, the middle stimulator
paddle portion 76 may have a negative pressure or positive pressure
balloon for placement and securing properties. The middle
stimulator paddle 76 may have the ability to be mobile where the
practitioner by methods and means outside the patient's body may
control the placement of the middle stimulator paddle by rotation,
magnets, hydraulics, electronics, mechanical means, and/or pulley
system where the middle stimulator paddle portion 76 may traverse
up and down the middle portion 71 of the expandable dual input dual
source spinal cord stimulator lead EDIDS 70 within the epidural
space of the spine (not shown). The middle portion 71 of the
expandable dual input dual source spinal cord stimulator lead EDIDS
70 may be entered into the epidural space (not shown) of the spinal
cord (not shown) by percutaneous epidural needles (not shown) using
the percutaneous technique described above. The middle portion 71
of the expandable dual input dual source spinal cord stimulator
EDIDS 70 may be controlled outside the patient's body by a
practitioner by manipulating the distal end 74 and/or the proximal
end 79. The practitioner having control of both the distal end 74
and proximal end 79 with middle portion 71 within body thus has the
ability to control the middle portion 71 by pulling the distal end
74 or proximal end 79 in a backward or forward motion. As the
practitioner may be able to control the distal portion 74 and
proximal portion 79 of the expandable dual input dual source spinal
cord stimulator lead EDIDS 70, the practitioner also has control of
the middle portion 71 where the middle stimulator paddle portion 76
and the middle stimulator electrodes MSE 78 may then be maneuvered
by pulling motion described above to the desired target area of the
dura of the spinal cord (not shown) where the middle stimulator
paddle portion 76 and the middle stimulator electrodes MSE 78 may
stimulate the targeted area overlaying the dura of the spinal cord
(not shown).
[0043] The expandable dual port dual source spinal cord stimulator
lead EDIDS 70 has a distal end 74 and proximal end 79 that may be
outside the patient's body (not shown). The distal end 74 and the
proximal end 79 have many functions including the above described
control of the middle portion 71 of the expandable dual input dual
source spinal cord stimulator lead EDIDS 70. Furthermore, the
distal end 74 may connect to an IPG unit 72a and the proximal end
79 may connect to an IPG unit 72. Additionally, the distal end 74
and proximal end 79 may be connected to each other to form a ring
(not shown) outside the patient. Additionally, the distal end 74
and the proximal end 79 may be secured in a way outside the
epidural space (not shown) that will prevent the middle portion 71
of the expandable dual port dual source spinal cord stimulator lead
EDIDS 70 from migrating from targeted area of dura of the spinal
cord in the epidural space of the spine (not shown). By securing
the distal portion 74 and the proximal portion 79 by anchoring
methods outside the epidural space (not shown) and with the middle
portion 71 now fixed in a desired location in the epidural space,
(not shown) with the middle stimulator paddle portion 76 and the
middle stimulator electrodes MSE 78 immobile and locked in a
targeted area overlaying the dura of the spinal cord, the
practitioner may thus effectively prevent the issue of migration of
paddles and thus eliminate the issue of lead migration seen in
conventional spinal cord stimulator leads or surgical stimulator
leads.
[0044] By way of non-limiting example, the benefit of having two
IPG units (distal IPG 72a and proximal IPG 72) gives the patient
and practitioner added advantage of extended battery life, smaller
IPG units as compared to traditional one port stimulators
(conventional percutaneous and surgical spinal cord stimulator
leads). The IPG units 72, 72a may have different frequency output
where one IPG unit may be of high frequency and the other IPG unit
may be of low frequency. The IPG units 72, 72a may have different
polarity where the one IPG unit may be negative and the other IPG
unit may be positive.
[0045] FIG. 8 is a perspective view demonstrating on a spine model
the dual input dual source spinal cord stimulator lead DIDS 60 in
the epidural space that has two positions that exit the spinal
canal, a proximal end 69 and a distal end 64 leaving a middle
portion 62 firmly secured in the epidural space of the spine (not
shown).
[0046] The dual input dual source spinal cord stimulator lead DIDS
60 may be any length in size. The dual input dual source spinal
cord stimulator lead DIDS 60 may be utilized in the cervical region
of the spine, thoracic region of the spine, lumbar region of the
spine and sacral region of the spine. The dual input dual source
spinal cord stimulator lead DIDS 60 may be placed anywhere along
the spine traversing one or many levels of the spine. In this
schematic representation only 6 vertebrae (V1 through V6) are
demonstrated for understanding. The actual length of the dual
source dual action spinal cord stimulator lead DIDS 60 may extend
at a minimum of one vertebra level or may extend from L5/S 1 (prior
art C) to C1/C2 (prior art C).
[0047] As the T-Technique has potential to be applied to any part
of the spine, the dual input dual source spinal cord stimulator
DIDS 60 using methods described by the T-Technique may be placed
and secured within the epidural space along any desired target area
of the dura of spinal card within the patient's spine.
[0048] The dual input dual source spinal cord stimulator lead 60
has a proximal part 69 that connects to a proximal IPG unit 66b and
distal part 64 that connects to a distal proximal IPG 66a. The dual
input, dual source spinal cord lead DIDS 60 has both its distal
part 64 and proximal part 69 outside the patient's body. The middle
stimulator paddle portion 66 that contains the middle stimulator
electrodes 65 which may vary in number typically 4, 8, 16, 32 or
more. In FIG. 8, the middle stimulator electrodes 65 number eight
and are represented by eight circle like figures. The distal end 64
of the dual input dual source spinal cord stimulator lead DIDS 60
exits the spinal cord between V1 and V2 through at the exit point
10. The proximal end 69 of the dual input dual source spinal cord
stimulator DIDS 60 enters the spinal cord between V5 and V6 through
the entrance point 8. The middle portion 62 of the dual input dual
source spinal cord stimulator lead DIDS 60 may be entered into the
epidural space of the spinal cord (not shown) by percutaneous
epidural needles (not shown) using T-Technique. The middle portion
62 of the dual input dual source spinal cord stimulator DIDS 60 may
be controlled outside the patient's body by practitioner by
manipulating the distal end 64 and or the proximal end 69. The
practitioner having control of both the distal end 64 and proximal
end 69 with middle portion 62 within body thus has the ability to
control the middle portion 62 by pulling the distal end 64 or
proximal end 69 in a backward or forward motion.
[0049] As the practitioner may be able to control the distal
portion 64 and proximal portion 69 of the dual input dual source
spinal cord stimulator lead 60, the practitioner also has control
of the middle portion 62 where the middle stimulator paddle portion
66 and the middle stimulator electrodes 65 may then be maneuvered
by pulling motion described above to the desired target area of the
dura of the spinal cord where the middle stimulator paddle portion
66 and the middle stimulator electrodes 65 may stimulate the
targeted area overlaying the dura of the spinal cord (In FIG. 8,
the dual input dual port spinal cord stimulator DIDS 60 middle
portion 62 may be seen laying beneath the V2, V3, V4, and VS where
the middle stimulator paddle portion 66 and middle stimulator
electrodes 65 may be seen laying beneath V2, V3, V4).
[0050] FIG. 9 is a schematic view of the expandable dual input,
dual source spinal cord lead (EDIDS) 70 in an epidural space. The
expandable dual input dual source spinal cord stimulator lead EDIDS
70 with the middle portion 71 secured in the epidural space the
proximal end 79 and distal end 74 outside the patient's body. The
vertebrae (VI, V2, V3, V4, V5 and V6) may represent any six or more
consecutive vertebrae of a spine. FIG. 9 is a schematic
representation describing the expandable dual input dual source
spinal cord stimulator EDIDS 70 in that it has two positions that
exit the spinal canal, a proximal end 79 and a distal end 74
leaving a middle portion 71 firmly secured in the epidural space of
the spine. As a person of ordinary skill in the art may readily
appreciate, the expandable dual input dual source spinal cord
stimulator lead EDIDS 70 may be any length in size, dependent upon
the treatment area. The expandable dual input dual source spinal
cord stimulator lead EDIDS 70 may be utilized in the cervical
region of the spine, thoracic region of the spine, lumbar region of
the spine, and/or sacral region of the spine. The expandable dual
input dual source spinal cord stimulator lead EDIDS 70 may also be
placed anywhere along the spine traversing one or more levels of
the spine. In this exemplary embodiment, only six vertebrae are
demonstrated, however, one of ordinary skill in the art may
determine that the actual length of the expandable dual source dual
action spinal cord stimulator lead EDIDS 70 may extend at a minimum
of one vertebra level or may extend from L5/S1 to C1/C2.
[0051] As a percutaneous technique of the spine has potential to be
applied to any part of the spine, the expandable dual input dual
source spinal cord stimulator EDIDS 70 may be placed and secured
within the epidural space along any desired target area of the dura
of spinal cord within the patient's spine. The expandable dual
input dual source spinal cord stimulator lead EDIDS 70 has a
proximal part 79 that may connect to a proximal IPG unit 72 and
distal part 74 that connects to a distal IPG 72a. The expandable
dual input, dual source spinal cord lead EDIDS 70 may have both its
distal part 74 and proximal part 79 outside the patient's body. The
middle stimulator paddle portion 76 contains the middle stimulator
electrodes MSE 78. In FIG. 9, the middle stimulator electrodes MSE
78 number fourteen, however one of ordinary skill can opt to use as
little as one single electrode or any combination of a plurality of
electrodes without departing from the teaching described herein. As
depicted in FIG. 9, the distal end 74 of the dual input dual source
spinal cord stimulator lead EDIDS 70 exits the spinal cord between
V1 and V2 through at the exit point 10. The proximal end of the
dual input dual source spinal cord stimulator DIDS enters the
spinal cord between V5 and V6 through the entrance point 8. The
middle portion 71 of the dual input dual source spinal cord
stimulator lead EDIDS 70 may enter the epidural space of the spinal
cord by percutaneous epidural needles. The middle portion 71 of the
dual input dual source spinal cord stimulator lead EDIDS may be
controlled outside the patient's body by a practitioner by
manipulating the distal end 74 and/or the proximal end 79. The
practitioner may have control of both the distal end 74 and
proximal end 79 with middle portion 71 within body thus has the
ability to control the middle portion 71 by pulling the distal end
74 or proximal end 79 in a backward or forward motion, as necessary
and determined by a practitioner.
[0052] As the practitioner may be able to control the distal
portion 74 and proximal portion 79 of the dual input dual source
spinal cord stimulator lead, the practitioner also has control of
the middle portion 71 where the middle stimulator paddle portion 76
and the middle stimulator electrodes MSE 78 may then be maneuvered
by pulling motion described above to the desired target area of the
dura of the spinal cord where the middle stimulator paddle portion
76 and the middle stimulator electrodes MSE 78 may stimulate the
targeted area overlaying the dura of the spinal cord.
[0053] FIG. 10 is a perspective view of a multi-channel dual input,
dual source spinal cord lead (MDIDS) 80. The multi-channel dual
input dual source spinal cord stimulator lead MDIDS 80 has a
proximal end 89 that connects to a proximal unit 87 and distal end
84 that connects to a distal unit 87a. The proximal unit 87 and
distal unit 87a may be an IPG unit or pain pump or both or have the
capabilities to be both including capabilities to be
interchangeable. The multichannel dual input dual source spinal
cord lead MDIDS 80 may have multiple lumens 82 that traverse within
it. The lumens 82 may be one, or more in number. In FIG. 10, a
schematic view of a lumen 82 may be seen traversing the length of
the multichannel dual input dual source spinal cord lead 80 and
pain pump MDIDS with a distal part 84, middle part 83 and a
proximal part 89.
[0054] The multichannel dual input, dual source spinal cord lead
MDIDS 80 may have both its distal part 84 and proximal part 89
outside a patient's body. The middle stimulator paddle portion 86
that contains the middle stimulator electrodes MSE 88, may vary in
number, typically 4, 8, 16, 32 or more. The middle portion 83 is
composed of the distal middle portion, the proximal middle portion,
and the middle stimulator paddle portion 86 with middle stimulator
electrodes MSE 88. The middle portion 83 of the multichannel dual
input, dual source spinal cord stimulator lead MDIDS 80 may reside
completely within the patient's body.
[0055] The lumen(s) 82 along the middle portion 83 of the
multichannel dual input dual source spinal cord lead MDIDS 80 may
have multiple pores or apertures 81 where medicines in the form of
gas, liquid, solid or other methods of drug delivery known in the
art may be released in the epidural space of the spinal cord. The
medicines in the form of gas, liquid, solid or other methods of
drug delivery known in the art may be stored in wells in either
proximal unit 87 or distal unit 87a or both. The middle portion 83
of the dual input dual source spinal cord stimulator lead DIDS 80
may be entered into the epidural space of a spinal cord by
percutaneous epidural needles. The middle portion 83 of the dual
input dual source spinal cord stimulator DIDS 80 may be controlled
outside the patient's body by a practitioner by manipulating the
distal end 84 and/or the proximal end 89.
[0056] Moreover, the practitioner having control of both the distal
end 84 and proximal end 89 with middle portion 83 within the body
thus has the ability to control the middle portion 83 by pulling
the distal end 84 or proximal end 89 in a backward or forward
motion. As the practitioner may be able to control the distal
portion 84 and proximal portion 89 of the multichannel dual input
dual source spinal cord stimulator lead MDIDS 80, the practitioner
also has control of the middle portion 83 where the middle
stimulator paddle portion 86 and the middle stimulator electrodes
MSE 88 may then be maneuvered by pulling motion described above to
the desired target area of the dura of the spinal cord where the
middle stimulator paddle portion 86 and the middle stimulator
electrodes MSE 88 may stimulate the targeted area overlaying the
dura of the spinal cord.
[0057] The distal end 84 and the proximal end 89 have many
functions including the above described control of the middle
portion 83 of the multichannel dual input dual source spinal cord
stimulator lead MDIDS 80, furthermore the distal end 84 may connect
to a distal unit 87a and the proximal end 89 may connect to a
proximal unit 87. Additionally, the distal end 84 and proximal end
89 may be connected to each other to form a ring or loop outside
the patient. Additionally, the distal end 84 and the proximal end
89 may be secured in a way outside the epidural space that will
prevent the middle portion 83 of the multichannel dual port dual
source spinal cord stimulator lead MDIDS 80 from migrating from
targeted area of dura of the spinal cord in the epidural space of
the spine. Securing the MDIDS 80 to the patient's body or to itself
may be accomplished by using any method readily known in the art,
for example, stitching, magnetics, or other coupling forms.
[0058] FIG. 11 is a schematic representation of two Dual Input Dual
Channel spinal cord stimulator leads DIDS A, B (may also represent
expandable and multichannel dual input dual channel spinal cord
stimulator leads EDIDS 70, MDIDS 80) demonstrating the ability to
connect to one another through interconnection X. Connection X may
allow data, energy current, lumens that share medicine to flow
between two leads. The connection may also be utilized for
stability of the stimulator lead as well.
[0059] FIG. 12 is a schematic representation of a Self Contained
Spinal Cord Stimulator SCSCS 90 where the lead may be used to house
the software, hardware, computer 91, IPG unit 92, and battery
source 93, stimulator electrodes 96, flexible circuit board FCB 95,
connecting wires 97, all within the stimulator lead itself SCSCS 90
and all within the epidural space (not shown). Through utilizing
the percutaneous technique referenced above a proximal end 99 and a
distal end 94 may be used to anchor to suture, button, wire
mechanisms for stability or by using any other form of fixation
mechanism known in the art.
[0060] In this exemplary embodiment, the stimulator may be used to
house the software, hardware, IPG unit, and/or battery source all
within the stimulator lead 90 itself and all within the epidural
space in a sealable fashion. All components necessary to provide
relief may be housed inside the epidural space with no need for
external IPG or computer unit as seen in traditional stimulators to
date. Moreover, there is no exit out of the lead outside of the
epidural space. The proximal, middle and distal portions of the
spinal cord stimulator remain completely within the stimulator lead
90 which may reside in the epidural space. (A connecting piece for
fixation of the proximal and/or distal ends may minimally exit the
epidural space as necessary.)
[0061] Additionally, the battery 93 may be completely enclosed
within the stimulator lead 90 itself. The distal 94 and proximal
ends 99 of the lead of the spinal cord stimulator 90 may be
completely secured within the epidural space. The entire surface
area of the lead has potential to act as or contain electrodes 96
such that each particular region or area of the
stimulator/lead/electrode can be active or inactive. The areas of
active stimulation may be externally programed thus allowing the
practitioner to determine the optimal combination of active or
inactive stimulation to provide maximal pain relief for the
patient. To provide utmost safety and as a result of the fixation
at both the proximal 99 and distal ends 94 of the spinal cord
stimulator 90, the spinal cord stimulator 90 should allow for the
flexion and extension of the spinal cord stimulator that will
naturally occur in concert with the patient's movements. Similarly,
materials may be of nanotechnology origin, graphene, carbon, metal,
plastic, and/or rubber based. Additionally, all of the hardware and
all of the software may be located completely within the spinal
cord stimulator/lead inside the epidural space.
[0062] Power to the stimulate unit 90 may be provided by way of a
battery 93 that may be inside the epidural space completely
enclosed within the lead 90 itself or partially exposed for ease of
exchange. Computer processing may be based on an FPGA, ASIC, hybrid
analog-digital ASIC, or general purpose processor. The spinal cord
stimulator IPG unit 92 may also traverse the entire length of the
spinal cord stimulator and may be comprised of flexible or
miniaturized circuits 95. The computing capability and
firmware/software aspects may be completely housed within the
spinal cord stimulator 90 within the epidural space. The spinal
cord stimulator 90 may additionally have wireless capabilities.
Wireless communication may be any one of the applicable industry
standards, or a custom protocol, including WiFi (802.11a/b/g/n),
Bluetooth.RTM., Zigbee.RTM., or a custom protocol over the
dedicated medical body-area network within the FCC assigned
spectrum.
[0063] The SCSCS 90 may be able to charge its battery 93 that is
within the spinal cord stimulator 90 itself within the epidural
space through wireless technology where a transmitter will be on
the outside of the patient's body and able to recharge the battery
93 within the patient's body without direct contact, e.g., by
induction. Wireless interaction may be facilitated by the
practitioner or by the device itself via the computer or software.
For example, the practitioner may program the computer or software
within the spinal cord stimulator through wireless technology. This
technology will allow the practitioner the ability to choose which
electrodes are active or inactive and in what pattern, either fixed
or dynamic over time. Additional electrical parameters may be
modified as is readily known to those skilled in the art. For
example, wireless technology may also allow the practitioner to
determine and programmatically set the strength of the stimulation
at each active electrode, the duration of stimulation at each
active electrode, the amount of stimulation across all electrodes,
location of stimulation, the frequency or frequencies of
stimulation and give the practitioner the ability to make changes
and program the stimulator to allow for patient to achieve greatest
amount of pain relief.
[0064] There is also the option to allow for a smartphone
application that will provide the patient wireless access to be
able to control the spinal cord stimulator for his or herself. This
capability will allow the patient to determine the amount of
stimulation, what type of stimulation, such as high frequency or
low frequency, location such at which electrodes are active or
inactive, the length of stimulation, duration of stimulation and
other manipulations of the stimulation all through available
wireless technology.
[0065] The patient and/or practitioner may also capture information
and secure upload of that information on the stimulation
characteristics through a smartphone or other app to describe
patient's feedback on pain level, effective pain stimulation, high
vs low frequency to enable practitioner to zero in on the optimal
stimulation strategy.
[0066] In the latter disclosed embodiment, the lead and the
stimulator 90 are one and fit completely inside the epidural space.
The battery 93 may be fully contained within the stimulator lead
90. The electrodes 96 may run the length of the stimulator/lead 90.
The pattern of stimulation including frequencies, amplitudes, and
recruitment of electrodes may be programmable for pain relief. The
internal design may be either a single circuit board/single battery
or redundant circuit boards/redundant batteries. In the latter
case, the circuit boards and batteries may act as backup in a
failover architecture or run in parallel with each running its own
independent stimulation pattern.
[0067] FIGS. 13 and 14 represent the Dual Port Catheter Drug Pump
Delivery System that allows for drug delivery using two ports of
access that are independent of the MDIDS depicted in FIG. 10, which
is a combined dual port pain pump and stimulator representation.
FIG. 13 is a view of the Dual Port Catheter Drug Pump Delivery
System DPCDPD 100. The Dual Port Catheter Drug Pump Delivery System
DPCDPD 100 has a proximal end 119 that connects to a proximal drug
pump unit 117c and distal end 114 that connects to a distal drug
pump unit 117d. The proximal drug pump unit 117c and distal drug
pump unit 117d may be a drug pump delivery system where medicines
in the form of gas, liquid, solid or other methods of drug delivery
may be stored in wells that may later be pumped into the patient's
spine, intrathecal space, and/or epidural space. The Dual Port
Catheter Drug Pump Delivery System DPCDPD 100 may have multiple
lumens (not shown) that may traverse within its Dual Port catheter
120. The Dual port catheter 120 connects the proximal drug pump
unit 117c and the distal drug pump unit 117d with each other. The
lumens (not shown) may be one, or more in number.
[0068] The dual port catheter 120 of the Dual Port Catheter Drug
Pump Delivery System DPCDPD 100 may have both its distal part 114
and proximal part 119 outside the patient's body. The middle
portion 112 of the Dual Port Catheter 120 contains one or more
lumens (not shown). The lumen(s) (not shown) may have multiple
pores or apertures 111 where medicines in the form of gas, liquid,
solid or other methods of drug delivery may be released into the
epidural space of the spinal cord. In FIG. 13, the Dual Port
Catheter 120 displays pores 111 where medicines in the form of gas,
liquid, solid or other methods of drug delivery may be stored in
wells in either proximal unit 117a or distal unit 117b or both. The
Dual Port Catheter 120 of the Dual Port Catheter Drug Pump Delivery
System DPCDPD 100 may be entered into the epidural space of the
spinal cord by percutaneous epidural needles using the T-Technique.
The middle portion 112 of the Dual Port Catheter 120 may be
controlled outside the patient's body by a practitioner by
manipulating the distal end 114 and/or the proximal end 119. The
practitioner having control of both the distal end 114 and proximal
end 119 with middle portion 112 within body thus has the ability to
control the middle portion 112 by pulling the distal end 114 or
proximal end 119 in a backward or forward motion that may then be
maneuvered to lay upon the desired target area of the dura or
epidural space of the spinal cord. The distal end 114 and proximal
end 119 may be used to anchor the dual port catheter 120 once
desired positioning of the middle portion 112 is found.
[0069] FIG. 14 is a schematic view of a spine model and the Dual
Port Catheter Drug Pump Delivery System DPCDPD 100 in the epidural
space placed by percutaneous epidural needles using T-Technique.
The Dual port catheter 120 connects the proximal drug pump unit
117c and the distal drug pump unit 117d. The Dual Port Catheter
Drug Pump Delivery System DPCDPD 100 has two points of entry into
the spine of the patient with the Dual port catheter having a
middle portion 112 secured in the epidural space, the proximal end
119 and distal end 114 outside the patient's body. The vertebrae
(V1, V2, V3, V4, V5 and V6) may represent any six or more
consecutive vertebrae of the spine. The Dual Port Catheter Drug
Pump Delivery System DPCDPD 100 may have two positions that exit
the spinal canal, a proximal end 119 and a distal end 114 leaving a
middle portion 112 firmly secured in the epidural space of the
spine. The Dual Port Catheter Drug Pump Delivery System DPCDPD 100
may be any length in size. The Dual Port Catheter Drug Pump
Delivery System DPCDPD 100 may be utilized in the cervical region
of the spine, thoracic region of the spine, lumbar region of the
spine, and/or sacral region of the spine. The Dual Port Catheter
Drug Pump Delivery System DPCDPD 100 may be placed anywhere along
the spine within the epidural space or subdural space traversing
one or more levels of the spine.
[0070] Having a two pump system 117c, 117d may be advantageous in
the event of malfunction of one pump or if the catheter line
becomes blocked not allowing medicine to flow freely. If the
proximal drug pump unit 117c, is the main pump, and malfunctions or
becomes clogged the distal drug pump unit 117d will be alerted and
take over main pump duties to prevent a dangerous fall in
medication concentration. As depicted in FIG. 14, the pores or
apertures 111 that are represented by eleven circle like figures
are where the medicines will be distributed from into the epidural
space. In this depiction, the distal end 114 of the Dual Port
Catheter Drug Pump Delivery System DPCDPD 100 exits the spinal cord
between V1 and V2 through at the exit point 110. The proximal end
of the Dual Port Catheter Drug Pump Delivery System DPCDPD 100
enters the spinal cord between V4 and V5 through the entrance point
118. The middle portion 112 of the Dual Port Catheter Drug Pump
Delivery System DPCDPD 100 may be entered into the epidural space
of the spinal cord by percutaneous epidural needles using
T-Technique. The middle portion 112 of the Dual Port Catheter Drug
Pump Delivery System DPCDPD may be controlled outside the patient's
body by a practitioner by manipulating the distal end 114 and/or
the proximal end 119 as previously discussed.
[0071] The percutaneous technique and the system deployed therein
by plurality of embodiments described may also be adapted for use
in the periphery of the body. To be clear, although the exemplary
embodiments disclosed above pertain to deployment within an
epidural space, the stimulators and pain pumps herein described may
also be used outside the epidural space. In this embodiment,
percutaneous access may be gained as previously disclosed, but the
stimulator and/or pain pump may be advanced in through skin through
needle and placed into place along muscle, fat, nerve, or bone, as
desired with other end coming out of skin forming a loop and/or
connection in the body.
[0072] While the disclosed technology has been related in terms of
the foregoing embodiments, those skilled in the art will recognize
that the invention may be not limited to the embodiments described.
The present invention may be practiced with modification and
alteration within the spirit and scope of the appended claims.
Thus, the description is to be regarded as illustrative instead of
restrictive on the present invention.
[0073] The previous description is provided to enable any person
skilled in the art to practice the various embodiments described
herein. Various modifications to these embodiments will be readily
apparent to those skilled in the art, and the generic principles
defined herein may be applied to other embodiments. Thus, the
claims are not intended to be limited to the embodiments shown
herein, but is to be accorded the full scope consistent with the
language claims, wherein reference to an element in the singular is
not intended to mean "one and only one" unless specifically so
stated, but rather "one or more." All structural and functional
equivalents to the elements of the various embodiments described
throughout this disclosure that are known or later come to be known
to those of ordinary skill in the art are expressly incorporated
herein by reference and are intended to be encompassed by the
claims. Moreover, nothing disclosed herein is intended to be
dedicated to the public regardless of whether such disclosure is
explicitly recited in the claims. No claim element is to be
construed under the provisions of 35 U.S.C. .sctn. 112, sixth
paragraph, unless the element is expressly recited using the phrase
"means for" or, in the case of a method claim, the element is
recited using the phrase "step for."
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