U.S. patent number 3,659,615 [Application Number 05/044,406] was granted by the patent office on 1972-05-02 for encapsulated non-permeable piezoelectric powered pacesetter.
Invention is credited to Carl C. Enger.
United States Patent |
3,659,615 |
Enger |
May 2, 1972 |
ENCAPSULATED NON-PERMEABLE PIEZOELECTRIC POWERED PACESETTER
Abstract
An encapsulated non-permeable piezoelectric self-powered
pacesetter for implantation in an in vivo, or living, system in
which the pacesetter is sealed and enclosed in an envelope formed
of medical grade silicone rubber and preferably natural or
synthetic animal, plant or insect wax, in which a piezoelectric
poly-crystalline ceramic is completely embedded, enclosed or housed
to function as a mechanical to electrical energy converter, when
implanted near moving muscle in a living system, and without
connection with a separate source of electrical energy either
within or without the living system.
Inventors: |
Enger; Carl C. (Lakewood,
OH) |
Family
ID: |
21932215 |
Appl.
No.: |
05/044,406 |
Filed: |
June 8, 1970 |
Current U.S.
Class: |
607/35; 174/521;
607/36 |
Current CPC
Class: |
A61N
1/3785 (20130101) |
Current International
Class: |
A61N
1/378 (20060101); A61N 1/372 (20060101); A61n
001/36 () |
Field of
Search: |
;128/419P,419B,421,422,335.5,1R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Claims
I claim:
1. An encapsulated pacesetter implantable in a living system and
responsive to movement of an organic muscle to which it is applied
to stimulate and pace the natural movement of the muscle, said
pacesetter comprising a piezoelectric unit, a transducer, input
electrodes electrically connecting said transducer with said
generator unit, generator output electrodes for implantation in the
muscle tissue, an encapsulating envelope completely enclosing said
pacesetter, said envelope formed of a living tissue compatible
material consisting of medical grade silicone rubber and a natural
wax substantially uniformly and intimately integrated together as a
material possessing flexibility sufficient to respond to movement
of the muscle tissue in which it is implanted.
2. The invention as defined in claim 1 in which said envelope
comprises a natural wax inner enclosure for the generator and the
transducer and a medical grade silicone rubber, outer, living
tissue compatible envelope.
3. The invention defined in claim 1 in which the material forming
the capsule consists of a natural wax and medical grade silicone
rubber intimately and uniformly dispersed throughout the total mass
to form an envelope.
4. An encapsulated pacesetter comprising an elongate capsule
enclosing a piezoelectric generator unit at one end of the capsule,
a transducer unit enclosed in the capsule and extending in a
direction from said capsule end enclosing said generator to provide
a flat flexing portion responsive to movement of organic muscle
tissue in which the device is implanted in close proximity thereto,
input electrodes within the capsule electrically connecting said
transducer with said generator unit and generator output electrodes
for implantation in the muscle tissue, said capsule comprising a
mass consisting of medical grade silicone rubber and a natural
wax.
5. The invention of claim 4 in which said encapsulation consists of
an inner core of natural wax enclosing said generator, transducer
and input electrodes, and an outer relatively thin interface of
medical grade silicone rubber completely enclosing the core.
Description
THE INVENTION
This invention relates to pacesetters and more particularly to the
encapsulated type enclosing a piezoelectric poly-crystalline
ceramic mechanical to electrical energy converter wherein the
enclosure consists of a non-permeable envelope formed of medical
grade silicone rubber and natural or synthetic animal, plant or
insect wax to provide a compatible ion obstructing or excluding
interface between living tissue and the implant.
The invention embodies two forms, one of which may consist of a
material of uniformly integrated medical grade silicone rubber and
one or more natural or synthetic waxes of the type disclosed, or
another form consisting of a moulded wax providing a highly
non-permeable coating to prevent transfer of relatively highly
reactive electrolytes or other conductive moisture from entering
the areas in which the piezoelectric unit and its associated
electrical components are enclosed. The outer cover or envelope of
medical grade silicone rubber must be compatible with living
tissue, while the inner envelope provides a non-permeable coating
for the implantable electrical devices associated with the
piezoelectrical generator.
THE DRAWING
FIG. 1 is an enlarged longitudinal section illustrating
diagrammatically a form of pacesetter embodying the present
invention, in which the enclosure is an integrated envelope of
medical grade silicone rubber and a wax.
FIG. 2 is an end view of the same, and,
FIG. 3 is a modified form of the invention in which an enclosing
envelope is formed of an inner body of moulded wax and an outer
covering layer of medical grade silicone rubber.
DESCRIPTION
The figures illustrate forms of the invention which include an
encapsulation constructed of materials compatible with living
tissue with which they come into contact by implantation in a
living system. While the invention is especially useful as a heart
pacesetter for implantation in the chest cavity or adjacent to the
heart left ventricle, it is equally useful in other muscular areas
of the living system by implantation to stimulate and regulate
muscular activity as, for instance, pacing the bladder, blood
pressure control centers of the circulatory system,
gastro-intestinal tract, the pancreas and other electrically
controlled organs of the living system.
Due to its miniature size and compactness, relatively light weight,
non-permeability to body fluids and its ability to obstruct or
exclude ion passage therethrough, it is readily adaptable to these
many uses.
In the drawing, first referring to FIGS. 1 and 2, illustrating a
simplified and preferred form of the invention. In this embodiment,
which is shown somewhat enlarged for clearness, the encapsulation
is indicated generally at 10 and is formed of a mass composed of
substantially uniformly and intimately integrated medical grade
silicone rubber and one or more natural waxes of the type herein
disclosed, imparting a material having high non-permeable qualities
to prevent transfer of highly reactive electrolytes or other
conductive moisture from entering the areas in which the
piezoelectric generator unit and its associated electrical
components are enclosed, yet possessing flexibility sufficient to
react to muscular movement in the area of its implantation in a
living system. Such material is found to be compatible with living
tissue with which it comes into contact.
A transducer comprising elements 12 extend longitudinally along and
within the encapsulation 10 and have imput electrical connection
with a conventional piezoelectric generator unit 16 through
electrodes of platinum or other suitable tissue-compatible
conductors 18 and 20. Electrodes 18' and 20', respectively, are
electrically connected with the output side of the unit 16 for
purposes of delivering electrical impulses to the specific part of
the body or living system in which the electrodes are
implanted.
It is essential that the piezoelectric generator which is of very
high impedance have a relatively slight ability to flex or bend in
use to actively generate electrical energy. This is ensured by its
encapsulation in a moulded or formed envelope 14 as disclosed
herein.
The encapsulation 14 is preferably formed of either plant, insect
or animal wax as distinguished from synthetic wax materials, to
provide a highly non-permeable housing for the piezoelectric unit
16 and the transducer element 12 to prevent transfer of highly
reactive electrolytes or other conductive moisture from entering
the interior of the encapsulation 10.
Electrical generators such as piezoelectric bimorphs 12 have
internal impedances of approximately 20 megohms and are adequate,
for instance, for implantation in beeswax. Spermaciti, a mammal
wax, also provides suitable non-permeable qualities and such waxes
are compatible with living tissue. I have found that a thickness of
non-permeable wax of the group referred to, when applied in a
thickness of from 0.15 to 0.50 inch, is quite satisfactory.
I have found that the use of synthetic waxes as encapsulants are
permeated by ions under the conditions of use in a living system
and they do not maintain sufficient dielectric properties over a
long period of implantation.
In FIG. 3 is illustrated an embodiment 10a which in many respects
is similar to that described above in connection with the
description of FIGS. 1 and 2, but differs in that an outer envelope
of medical grade silicone rubber 22 completely encloses the inner
core or encapsulation surrounding the piezoelectric unit and
transducer elements 12a and provides a compatible, non-toxic
interface between the implant and the living tissue in contact
therewith.
The thickness of the envelope 22 may vary from 0.30 to 0.10 inch,
depending upon the location of the implant or the mechanical
requirements. The outer cover 22 also serves as a protective layer
over the inner wax encapsulation 14a against abrasion that
otherwise could occur in the presence of moving muscle or
tissue.
* * * * *