U.S. patent number 3,724,467 [Application Number 05/136,924] was granted by the patent office on 1973-04-03 for electrode implant for the neuro-stimulation of the spinal cord.
This patent grant is currently assigned to Avery Laboratories, Inc.. Invention is credited to Roger E. Avery, James G. Wepsic.
United States Patent |
3,724,467 |
Avery , et al. |
April 3, 1973 |
ELECTRODE IMPLANT FOR THE NEURO-STIMULATION OF THE SPINAL CORD
Abstract
An improved implantable device for electrically stimulating a
selected portion of the spinal cord is provided. A relatively thin
and flexible strip of physiologically inert plastic is provided
with a plurality of electrodes. Lead wires that are also
encapsulated in the same physiologically inert plastic material are
secured to the electrodes and extend therefrom at approximately the
same angle as the spine's posterior process. A packing gland may be
positioned about the lead wires to the electrodes to minimize
leakage of spinal fluids.
Inventors: |
Avery; Roger E. (Mellville,
NY), Wepsic; James G. (Jamaica Plains, MA) |
Assignee: |
Avery Laboratories, Inc.
(Farmingdale, NY)
|
Family
ID: |
22475037 |
Appl.
No.: |
05/136,924 |
Filed: |
April 23, 1971 |
Current U.S.
Class: |
607/117 |
Current CPC
Class: |
A61N
1/0551 (20130101) |
Current International
Class: |
A61N
1/375 (20060101); A61N 1/05 (20060101); A61N
1/372 (20060101); A61n 001/04 () |
Field of
Search: |
;128/2.6E,2.1E,404,410,411,416,417,418,419C,419E,419R,DIG.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Claims
What we claim as new and desire to secure by Letters Patent is:
1. An improved implant for the electrical stimulation of selected
portions of the spinal cord of a human being, said implant
comprising a relatively thin, physiologically inert plastic body
portion having upper and lower surfaces, said body portion being
substantially flat and sufficiently flexible so as to conform to
the shape of the surface of the spinal column of a human being, a
plurality of metallic electrodes secured to said body portion of
said implant, said electrodes being adapted to be placed in contact
with a selected portion of the spinal column of a human being, the
contact surface of said electrodes being in a plane that is outward
of the plane of said lower surface of said body portion of said
implant and lead means coupled to said electrodes, said lead means
being positioned at an angle of between 15.degree. to forty-five
degrees with respect to the plane of said body portion to thereby
approximate the angle of the spine's posterior process for
minimizing the likelihood of pulling the implant away from the
spinal cord due to motion of the human's back or the muscles
surrounding said implant, said lead means extending from said upper
surface of said body portion opposed to said electrodes.
2. The implant in accordance with claim 1 wherein said angle is
thirty degrees.
3. The implant in accordance with claim 1, wherein said body
portion extends laterally beyond said electrodes in at least one
direction for defining an extension that is trimmable after said
implant final location is determined.
4. The implant in accordance with claim 3 wherein said body portion
extends laterally in two opposite directions beyond said
electrodes.
5. The implant in accordance with claim 1 wherein said electrodes
are arrayed in an alternating pattern on opposite sides of a
longitudinal line defined by the juncture of said lead means and
said body portion.
6. The implant in accordance with claim 1 wherein said electrodes
are arrayed along a linear path that is laterally spaced from and
substantially parallel to a longitudinal line defined by the
juncture of said lead means and said body portion.
7. The implant in accordance with claim 1 wherein there is further
included a recess in said body portion for receiving each of said
electrodes.
8. An improved implant for the electrical stimulation of selected
portions of the spinal cord, said implant comprising a
physiologically inert plastic body portion, a plurality of metallic
electrodes secured to said body portion, lead means coupled to said
electrodes,said lead means being positioned at an angle of between
15.degree. to 45.degree. with respect to the plane of said body
portion and strain relieving means comprising a physiologically
inert strip wrapped around said lead means remotely from said body
portion of said implant, said strain relieving means being adapted
to be sutured in said remote location.
9. An improved implant for the electrical stimulation of selected
portions of the spinal cord, said implant comprising a
physiologically inert plastic body portion, a plurality of metallic
electrodes secured to said body portion, lead means coupled to said
electrodes, and strain relieving means comprising a physiologically
inert strip wrapped around said lead means remotely from said body
portion of said implant, said strain relieving means being adapted
to be sutured in said remote location.
10. An improved implant for the electrical stimulation of selected
portions of the spinal cord, said implant comprising a
physiologically inert plastic body portion, a plurality of metallic
electrodes secured to said body portion, lead means coupled to said
electrodes, said lead means being positioned at an angle of between
15.degree. to 45.degree. with respect to the plane of said body
portion of said implant and a packing gland surrounding said lead
means at a position proximate said body portion of said implant for
minimizing leakage of cerebral spinal fluid, said packing gland
being comprised of a plurality of fibers bonded to said lead
means.
11. An improved implant for the electrical stimulation of selected
portions of the spinal cord, said implant comprising a
physiologically inert plastic body portion, a plurality of metallic
electrodes secured to said body portion and a packing gland
surrounding said lead means at a position proximate said body
portion of said implant for minimizing leakage of cerebral spinal
fluid, said packing gland comprising a plurality of fibers bonded
to said lead means.
Description
The aforementioned Abstract is neither intended to define the
invention of the application which, of course, is measured by the
claims, nor is it intended to be limiting as to the scope of the
invention in any way.
This invention relates generally to neuro-stimulating implants and
more particularly to an implant for electrical connection to the
spinal cord.
BACKGROUND OF THE INVENTION
Neuro-stimulation has been applied to patients with severe pain
states that are not relieved by traditional procedures and who
require large doses of narcotics to control pain. After the first
several implantations, it has become clear that those patients with
some form of partial peripheral nerve injury resulting in
"traumatic neuropathy" and who display the phenomenon of
hyperpathia seem to respond most favorably to stimulation of the
appropriate nerve. Similarly, patients with dysesthesias related to
spinal cord dysfunction seem to respond best to stimulation of the
dorsal column.
Implantable electrodes which have been used in the past to
stimulate a portion of the spinal cord have been characterized by
relatively large bulk. Normally the implant is sutured into place
beneath the dura. However, with the prior art devices considerable
pressure was thereby applied to the spinal cord. Further, the prior
art devices of this class attempted to stimulate both the left and
right-hand portions of the dorsal side of the spinal cord
simultaneously.
The early use of the prior art implants proved to have several
disadvantages in that they were too cumbersome and large to be
placed neatly under the dura without causing undue pressure. The
earliest models had to be removed due to the fact that they
stressed the spinal cord so much that the patient became partly
paralyzed in the lower extremity.
Another difficulty of the prior art structure was that the
stimulation of the spinal cord was impeded or, in some cases, cut
off entirely due to dislocation of the electrode from the cord
caused by stretching and twisting of the torso.
The present invention overcomes the shortcomings of the prior art
by using a relatively thin and flexible strip of physiologically
inert plastic, such as Dacron reinforced silicone rubber. A
plurality of electrodes are imbedded in two layers of the plastic
material. The conductive leads, encapsulated in the physiologically
inert plastic material, are electrically coupled into the
electrodes and extend therefrom at an angle that is closely aligned
to the spine's posterior process angle. In addition, construction
of the present invention further minimizes the likelihood that the
motion of the back or the muscles surrounding the implant will pull
the electrodes away from the spinal cord and cause a cessation of
stimulation by providing a physiologically inert plastic tie down
clamp for the leads.
Accordingly, it is a primary object of the present invention to
provide an improved neuro-stimulating implantable device.
It is another object of the present invention to provide an
improved implantable device, particularly for the spinal cord, that
will minimize the likelihood of the electrodes being detached or
spaced inadvertently from the spinal cord as a result of movement
of the patient.
It is a particular object of the present invention to provide an
improved implantable device, as described above, wherein the leads
that are coupled to the electrode are disposed at an angle
substantially aligned with the spine's posterior process angle.
These and other objects, features and advantages of the invention
will, in part, be pointed out with particularlity and will, in
part, become obvious from the following more detailed description
of the invention, taken in conjunction with the accompanying
drawings, which form an integral part thereof.
BRIEF DESCRIPTION OF THE DRAWING
In the drawing:
FIG. 1 is a perspective view of an improved implantable nerve
stimulating device fabricated in accordance with the teachings of
the present invention;
FIG. 2 is an enlarged side elevational sectional view of the device
shown in FIG. 1;
FIG. 3 is a cross-sectional view schematically illustrating the
spinal column of a human being together with the present invention
positioned thereon;
FIG. 4 is a schematic plan view illustrating another feature of the
invention;
FIG. 5 is a plan view of a neuro-stimulating implantable device, as
described above, with the leads removed in order to illustrate the
relative position of the plurality of electrodes;
FIG. 6 is a plan view of an alternative embodiment of the present
invention;
FIG. 7 is a plan view of an alternative lead arrangement; and
FIG. 8 is a cross-sectional elevational view taken along line 8--8
of FIG. 7.
Referring now to the drawings, and in particular to FIG. 1, there
is shown an implantable device comprising the present invention.
The neuro-stimulating implant 10 is comprised of a physiologically
inert plastic body portion 12 fabricated from a material such as
Dacron reinforced silicone rubber. A plurality of electrodes 14 are
imbedded in the body portion 12 and a plurality of electrically
conductive lead means 16 are suitably coupled to the electrodes 14.
As is well known in the art, the lead means 16 may be electrically
coupled to an RF receiver 17 that may be remotely implanted.
Referring particularly to FIG. 2, it will be seen that the body
portion 12 of the spinal cord implant 10 is comprised of first and
second layers 18 and 20 of a physiologically inert plastic material
such as that mentioned above, the layers 18 and 20 being suitably
secured to each other, such as by heat sealing or the like. The
electrodes 14, which preferably are made of platinum, are secured
to the plastic layer 18 by means of a platinum staple 22 that is
welded to the electrode 14 and crimped about the plastic layer 18.
After crimping, the second plastic layer 20 is sealed to the first
plastic layer 18. It should be noted that the lead means 16 are
comprised of a first platinum section 24 that is welded to the
staple 22 and a second stainless steel section 26 that is welded to
the platinum lead section 24. A physiologically inert plastic
material, such as described above, is used as a sleeve 28 about the
lead means 16.
FIG. 2 also illustrates a very important feature of the present
invention. It will be noted that lead means 16, which are encased
in the plastic sleeve 28, are positioned at an angle .alpha. with
respect to the plane of the body portion 12. It has been found that
molding the plastic sleeve at an angle that approximates the angle
of the spinal process minimizes the likelihood of the implant being
displaced away from the spinal cord due to movement of the
patient's torso or stretching of the muscles. An acceptable average
angle has been found to be within the angle of 15.degree. to
45.degree., preferably about 30.degree..
Referring now to FIG. 3 which is a transverse cross-section of a
typical spinal column, there is shown the implant 10 positioned on
the dorsal side. It will be readily appreciated that the implant 10
can be laterally shifted or positioned to contact either the
fasciculus cuneatus, the fasiculus gracilis, or both.
As shown in FIG. 4, it is preferable that the lead means 16 are
centered and that the body portion 12 extends on opposite sides of
the longitudinal axis L and on opposite sides of the electrodes 14
for a distance that is somewhat greater than is actually required.
Thus the surgeon may laterally shift the implant 10 to the optimum
position and, after trimming away the unnecessary sections which
are schematically designated as T, still have enough reinforced
plastic material to apply sutures.
In one embodiment of this invention, as shown, for example, in FIG.
1, strain relief tie down means 32 are provided. The tie down means
32 is comprised of a strip of physiologically inert plastic
material similar to the body portion 12. The strip 32 is wrapped
around the lead means 16 remote from the body portion 12 and is
then sutured in place. In this manner, the forces that are applied
to the lead means 16 as a result of the patient moving his torso
will not be transmitted to the body portion 12.
FIG. 5 shows a preferred pattern for the electrodes 14. It will be
noted that the electrodes 14 are relatively close together and
grouped about the longitudinal axis L of the implant 10. This has
been found to be preferable for bilateral spinal cord implants. In
this instance the leads 16 are shown in a single row so that the
dura need be spread only slightly to permit their exit.
An alternative embodiment of the present invention for placement on
the spinal cord is illustrated in FIG.6. The electrodes 14' are
mounted on the body portion 12', as described above, but in tandem
and on one side thereof. This construction provides means to
stimulate only one side of the spinal cord. By way of example, the
embodiment illustrated in FIG. 6 is in practice, 20 mm. from top to
bottom and 15 mm. from the left edge to the right edge. The
right-hand side of the electrodes 14 are spaced approximately 31/2
mm. from the right-hand edge of the plastic body portion 12'.
It will be noted that electrodes 14' are off center with respect to
the center line L on which the lead 16 extends. Thus it will be
appreciated that although contact is made to the spinal cord along
line A, the leads 16 are taken off the center of the dorsal column
at line L, and yet there is enough material at portions 30 and 30'
to permit suturing.
It is important to minimize the size of the exiting lead length to
minimize the cerebral spinal fluid leak from the dural incision. An
alternative arrangement is shown in FIGS. 7 and 8 where the exiting
leads 16' are grouped within the minimum circumscribing circle. The
lead sheaths have bonded to their surface for about three-eighths
inch of their length fine fibers in the form of a felt which acts
as a packing gland 70. The surgeon gathers the dura about the
"packing gland" employing a purse stitch S. The Dacron felt is
receptive to the growth of tissue so that ultimately a non-porous
seal is formed for the cerebral spinal fluids.
It has been found that the plastic sheet should be provided with
recesses 23 as shown in FIG. 2 for receiving the cupped contact
member. This is accomplished by molding the sheet between suitably
shaped platens. Such molding techniques are well known and do not
require further amplification. This arrangement serves to fix the
contact element against rotation and also covers the sharp edge of
the sheet metal contact button.
From the foregoing, it will be appreciated that an improved
implant, particularly for the spinal cord, has been provided. By
positioning the lead wires at an angle that corresponds with the
angle of the spinal posterior process, the likelihood of
inadvertent displacement of the implant by virtue of the movement
of the patient's torso or flexing of the muscles is substantially
minimized.
There has been disclosed heretofore the best embodiment of the
invention presently contemplated. However, it is to be understood
that various changes and modifications may be made by those skilled
in the art without departing from the spirit of the invention.
* * * * *