U.S. patent number 3,692,027 [Application Number 05/136,789] was granted by the patent office on 1972-09-19 for implanted medication dispensing device and method.
Invention is credited to Everett H. Ellinwood, Jr..
United States Patent |
3,692,027 |
Ellinwood, Jr. |
September 19, 1972 |
IMPLANTED MEDICATION DISPENSING DEVICE AND METHOD
Abstract
A self-micro-powered implanted device contains a store of
medicine in powdered, liquid or other dispensable form and which is
gradually discharged incrementally over a substantially long period
of time.
Inventors: |
Ellinwood, Jr.; Everett H.
(Durham, NC) |
Family
ID: |
22474370 |
Appl.
No.: |
05/136,789 |
Filed: |
April 23, 1971 |
Current U.S.
Class: |
604/891.1;
604/502 |
Current CPC
Class: |
A61M
5/14276 (20130101) |
Current International
Class: |
A61M
5/142 (20060101); A61m 007/00 () |
Field of
Search: |
;128/2P,1,260,261,214E,214F |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Claims
What is claimed is:
1. A device adapted to be positioned internally of a selected body
for dispensing materials therein, comprising:
a. a storage member adapted to be positioned within the selected
body and to store a quantity of the material to be dispensed;
b. a micro size power source secured within said body proximate
said storage member and having an output member capable of being
driven by said source over a predetermined period in terms of at
least several days and at a substantially precise rate; and
c. dispensing means powered and timed by said micro power source
and adapted to discharge from said storage member and into said
body on a predetermined time schedule successive increments of said
material.
2. A device as claimed in claim 1 wherein said body is that of an
animal including human, said material is a liquid, said storage
member constitutes a bladder and said dispensing means constitutes
pump and valve means powered and timed by said source and having an
inlet connected to said bladder and an outlet whereby said liquid
may be withdrawn from said bladder and discharged from said outlet
in increments.
3. A device as claimed in claim 1, wherein said body is that of an
animal including human, said material is a medication, said storage
member provides a plurality of cavities each having a predetermined
unit of said medication, and said dispensing means includes a
piston operator for each such cavity and linkage means operated by
said power source whereby each respective such piston operator is
activated in turn and effects successive discharge of each
respective said unit from said storage member.
4. A device as claimed in claim 3 wherein said storage member is
circular and is rotatively indexed by said power source to effect
discharge of said units.
5. A device as claimed in claim 3 wherein said storage member is
circular and fixed relative to said power source and said power
source rotatively indexes itself to effect discharge of said
units.
6. A device as claimed in claim 1 including a case providing an
internal void and having an aperture in the wall thereof and
wherein said micro power source and dispensing means are mounted
within said case and dispensing of said material is through said
aperture.
7. An implantable device for dispensing a medication material
within an animal body, said device comprising in combination:
a. a case adapted to be implanted in the body and providing an
internal void;
b. a micro power source secured within said void and having an
output member capable of being driven by said source over a
predetermined period in terms of at least several days and at a
substantially precise rate;
c. holder means mounted within said void and loosely mounting
premeasured units of said material in a circular configuration;
and
d. ejection means powered by said output member in timed relation
with said holder means and operative upon each successive said unit
of material whereby each said unit is successively discharged from
said holder means internally of said body.
8. A device as claimed in claim 7 wherein said case includes an
aperture in the wall thereof, said holder means rotates and is
driven by said output member to bring each successive unit to a
position opposite said aperture and said ejection means operates
upon each said unit successively upon reaching such position.
9. An implantable device for dispensing liquid drugs into an animal
body, including human, comprising:
a. a bladder adapted to be implanted in the body and to be filled
by external injection;
b. a metering means having an inlet connected to said bladder and
an outlet adapted to discharge into said body said metering means
being adapted in one mode to withdraw and discharge predetermined
uniform units of said material and in another mode to block flow of
said material;
c. a micro power source connected to said metering means and
adapted to power and time said metering means in said modes whereby
said units may be discharged at spaced time intervals and over a
substantially long period of time; and
d. a case adapted to be implanted and mounting both said metering
means and micro power source.
10. A device as claimed in claim 9 wherein said metering means
constitutes a pumping device.
11. The method of dispensing a drug in a body, comprising the
steps:
a. implanting within the body a container having a substantially
large supply of the drug to be dispensed;
b. with said container implanting a micro power source and
dispensing means operated and timed by said micro power source for
drawing off and discharging successive uniform units of said drug
in said body; and
c. allowing said source and dispensing means to operate on said
supply over a substantially long period of time until said supply
is exhausted.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention:
This invention pertains to dispensing medicine internally and more
specifically to dispensing a premeasured dosage at specific
intervals over a long period of time.
2. Description of the Prior Art:
Dosages of medicine have conventionally been dispensed in capsules
which release the medication either immediately or on a delayed
basis normally measured at the most in terms of a number of minutes
or relatively few hours. It has been proposed to have orally
administered capsules which can be caused to disintegrate by
externally applied heat or other forms of radiation designed to
penetrate the body and break down the capsule housing. There has
further been proposed a device (U.S. Patent No. 3,527,220) suited
to be implanted and designed to discharge successively, by pumping
units of liquid medication with the operating power for the device
being supplied by an external rotating magnetic field and whose
timing depends on an external source. It has also been proposed to
provide a multi-unit capsule designed to release one strength
medication at one time and another strength medication at another
time.
Representative prior art is found in U.S. Pat. Nos. 2,921,584,
3,118,439, 3,313,289, 3,315,660, 3,447,161, 3,485,235 and
3,527,220.
A review of all the known prior art reveals that there has not been
available a device operative on and timed by its own micropower
source, suitable to being entirely implanted and adapted to
dispensing premeasured dosages of a given medication, liquid,
powdered or otherwise, to a patient at specific intervals, which
might be 12 hours, 6 hours or even 6 days, over a long period of
time measured in terms of 1 to 2 years. In particular, there is no
device presently known which can be implanted in narcotic addicts
and/or psychiatric patients which can be used to administer
medication internally on a predetermined long term schedule. Long
term treatment of the addict with narcotic antagonist medication is
a means of blocking the effects of subsequent self-injected
narcotic drugs. In a similar vein, long term administration of an
anti-psychotic medication to certain psychiatric patients would be
of marked benefit in rendering them more adaptable to themselves
and society.
SUMMARY OF THE INVENTION
The present invention resides around the concept of implanting a
container within which there is mounted a battery powered,
microsource of power, a store of premeasured dosages of a given
medication and a mechanism operated and timed by the power source
and designed to eject the dosages at specific intervals over a long
period of time.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevation view of the device with one cover side
section removed.
FIG. 2 is an enlarged fragmentary partial section view taken
substantially along line 2--2 of FIG. 1.
FIG. 3 is a fragmentary section view taken substantially along line
3--3 of FIG. 2.
FIG. 4 is an enlarged fragmentary partial section view, similar to
FIG. 2, of a second embodiment.
FIG. 5 is a fragmentary section view taken substantially along line
5--5 of FIG. 4.
FIG. 6 is an enlarged fragmentary partial section view of a third
embodiment.
FIG. 7 is a fragmentary partial section view of the pump component
shown in FIG. 6.
FIG. 8 is a fragmentary partial section view of the bladder
component of FIG. 6.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The device of the invention includes a case 10 having two side
sections 11 and 12 secured by a suitable threaded connection 13.
The outer surface of case 10 provides an essentially solid surface
with the exception of an aperture 14 through which the individual
dosages are ejected at specific intervals. Case 10 can be thought
of as essentially resembling the case of an ordinary pocket watch
and in one embodiment is 6 centimeters in diameter by 1.4
centimeters thick. The surface should be smooth.
Since case 10 is designed to be implanted, the choice of material
of which case 10 is made is somewhat critical. Such material should
be of minimum weight, non-allergenic, non-reactive to body fluids
and adapted to mass fabrication. Stainless steel is one such
material though plastics and other materials may be employed.
Within case 10 there is mounted a suitable battery powered "micro"
power and timing source 24 which is preferably a so-called
"accutron" movement made by the Bulova Watch Company of Flushing,
N.Y. A movement of this kind is relatively light in weight and can
be obtained designed to turn one revolution per day so as to drive
a drive shaft 20 and a drive wheel 21 at one revolution per day and
for a period of time up to and approximately two years according to
battery life. At this speed output shaft 20 can be made to produce
approximately 0.42 ounce/inch of torque and with a very nominal
increase in speed at this loading. Such a power and timing source
is considered a "micro" power and timing source. The invention
recognizes the unique capability of the "Accutron" movement to
serve as a micropower and timing source outside its conventional
use for watches and clocks. The invention also recognizes that
pistons, cocking mechanisms and the like within the realm of
watchmaking technology can be practically applied in a medicine
dispensing device.
A circular wheel member 25 has an outer peripheral face 26 in which
there are formed a plurality of cavities 27 in which the individual
dosages C are contained. In one example, 72 such cavities are
formed in wheel 25 and each such cavity contains one capsule C of
the desired medication. Each cavity has an associated piston member
31 which when moved radially outward in a timed sequence ejects its
respective capsule C through aperture 14. Thus, for a 72 cavity
wheel member 25 there are 72 piston members 31.
Drive wheel 21 mounts on its periphery an indexing pin 28 which is
positioned perpendicular to the plane of wheel 21. As drive wheel
21 rotates at one revolution per day it causes indexing pin 28 to
rotate at the same speed and to drive a link 29 which in turn is
connected to oscillate a piston pusher member 30. Piston pusher
member 30 thus moves back and forth once a day in the embodiment
being described. As piston pusher 30 moves forward it is adapted to
engage a selected piston member 31 each of which has a compression
spring 32, a pusher head 33 and a piston 34 which bears against the
capsule C. Each compression spring 32 tends to always retain its
particular associated piston member 31 moved radially inwardly.
Indexing of wheel member 25 is effected by means of indexing pin 28
successively engaging each one of a plurality of peripherally
spaced indexing tabs 35 formed internally of wheel 25 as shown in
the drawings. Wheel 25 is supported on a precision pin 36 mounted
in suitable bearings 37 and 38. A washer 39 provides support for
piston pusher 30 which is guided by a guide pin 40 internally
secured to case side section 12. To prevent the entry of moisture
internally of case 10 an O-ring seal 41 is suitably adhered to case
10 around the aperture 14.
Here it should be noted that since body fluids may contact O-ring
41 and may also contact the interior of each individual
capsule-cavity and piston member 31 that the same criteria applying
to case 10 applies to the choice of materials selected. That is,
none of the materials employed in wheel member 25, piston member 31
or O-ring 41 should be allergenic or reactive with any body fluid
which might make contact with the same. Those skilled in the art
will however recognize a wide choice of materials.
In one embodiment the device is implanted in the patient's
abdominal intraperitoneal cavity, a cavity that has a glistening
moistened surface but does not maintain fluid levels except in
pathological conditions. The device is sutured by suture threads
secured to anchoring stays 15. The device of the invention then
dispenses medication into this cavity for absorption through the
intraperitoneal surface. The device is intended as a general
application for any feasible medication; however, there are
specific applications for which it is being developed. One such
application is to implant the device into the abdomen of narcotic
addicts with a sufficient number of dosages of a narcotic
antagonist, to be dispensed over a long period of time. The
narcotic antagonist dispensed actively, blocks the euphoriant
effect of any subsequent use of narcotics. A psychotic medication
can also be administered to psychiatric patients. This means that
from the viewpoint of the patient, the doctor, and society, that
the patient obtains the required daily dosage of a given drug
without having to rely on his own willpower and initiative.
In the embodiment of the medication dispensing device used as an
example, an Accutron movement or battery powered micro power plant
is used to provide the timing mechanism as well as a source of
power and the movement is geared to drive the output At FIGS. shaft
clockwise, one revolution per day. In the more general application,
any "micro" power and timing mechanism could be used. However, by
using extreme care in reducing weight and friction in all of the
moving parts of the device the Accutron movement in the present
state of the art is preferred and can provide sufficient torque as
well as long term continuous operation.
In use, the device is assembled with each dosage cell or cavity of
wheel member 25 being loaded with a capsule C of the active
medication and is suitably implanted. Each capsule C with the
medication inside is successively ejected by means of its
associated respective piston member 31 into the body cavity and
subsequently dissolves as wheel member 25 gradually indexes around.
In the embodiment of the example, the piston member 31 is designed
to have a stroke of approximately 0.50 centimeters and each
indexing tab 28 a movement of approximately 5 degrees and for each
rotation of drive wheel 21 indexing pin 28 will contact a
particular indexing tab 35 over approximately 30.degree. of
movement of wheel 21. This motion is thus repeated once a day and
one capsule C is thus ejected each day. At the end of the battery
life of the Accutron movement, the device may be removed, a new
battery installed, wheel 25 reloaded and the device reassembled and
reimplanted. It may also be noted that while capsules C are shown
on FIGS. 2 and 3, each cavity 27 could be loaded with a liquid,
powdered or granular medication and sealed with a fracturable seal
as depicted in FIGS. 4 and 5 and later explained.
FIGS. 4 and 5 illustrate a second embodiment in which the "case" is
formed by a stationary circular medication storage wheel member 50
and a base plate 51 having a suitable threaded connection 52. The
same "micro" power and timing source 24 is employed to drive a
similar output shaft 20, drive wheel 21 and indexing pin 28. Spaced
indexing tabs 55, similar to tabs 35 of FIGS. 1 and 3, are provided
on an internal peripheral surface of wheel member 50. In this
embodiment, wheel member 50 remains stationary and is provided on
an outer peripheral surface with plural cavities 56, e.g. 72 in
number, each of which is shown loaded with a dosage of granular or
powered medication M. Each cavity 56 is sealed by a rupturable film
seal 57 of suitable thinness and strength that is ruptured when the
particular dosage is ejected. A piston 60 is located in each cavity
56 and is formed integral with a piston rod 61 and a pusher head
63. A compression spring 62 forces piston 60 in a radially inward
direction.
Each respective pusher head 63 is successively engaged by a piston
pusher 65 which is guided by a guide pin 66 and a bearing pin 67.
Piston pusher 65 mounts a vertical locking pin 68 which
successively slides in and out of each corresponding indexing slot
69 as each respective pusher head 63 is engaged. Piston pusher 65
is in turn linked to indexing pin 28 by means of a link 70 and a
pin 71.
The micro power and timing source 24 indexes itself in a slow
rotative movement around the bearing pin 67 by means of indexing
pin 28 going in and out of successive indexing slots 69. That is,
as wheel 21 rotates, indexing pin 28 rotates and causes power
source 24 as well as all of the linkage shown mounted above power
source 24 to index by the angular difference between slot
locations. Ball bearings 49 support the power source 24 and bearing
pin 67 provides low friction surfaces. Furthermore, as indexing pin
28 leaves a particular indexing slot 69, piston pusher 65 is moved
to engage a respective pusher head 63 and to cause locking pin 68
to enter and lock itself in an opposite indexing slot 69 (now
effectively a "locking slot"). As piston pusher 65 continues to
move under the influence of indexing pin 28, which is always in
slow constant rotation, the respective piston 60 pushes on the
respective dosage M and ruptures the seal 57 which allows the
dosage M to dump internally of the body in which the device is
implanted.
In a third embodiment shown in FIGS. 6, 7 and 8, the medication is
in liquid form and is stored in a bladder 80 having a flexible
discharge line or tube 81 converted to a micro powered and timed
pump-valve unit 82 which discharges through a flexible line or tube
83. Lines 81 and 83 should preferably be flexible and may be in the
nature of rubber tubing. The bladder and pump-valve unit 82 may be
sutured by means of suture stays 84, 85 and line 83 is placed where
desired in the body.
Bladder 80 includes a self-sealing port preferably having two
self-sealing membranes 90, 91 and an internal filling cavity 92
with a one-way valve generally represented at 93. The outer case of
bladder 80 is preferably of hard rubber except at the port and a
hard rubber striker plate 95 is provided internally to prevent
inadvertent puncturing and also to prevent entry of the syringe
needle beyond the filling cavity 92. In use, bladder 80 is filled
with the desired liquid medication by syringe injection into the
cavity 92 such that the one-way valve 93 opens and allows the
liquid medication to fill the interior of bladder 80. Once the
syringe has been withdrawn it can be seen that bladder 80 is
effectively filled with a pressurized liquid medication yet the
patient, e.g. an addict, cannot withdraw the medicine himself as he
normally would be tempted to do.
A suitable pressure reducing valve 100 controls the flow to line 81
and to the pump unit 82 having a pair of spring-loaded one-way ball
valves 101, 102; valve 101 controlling entry and valve 102
controlling discharge of liquids from cylinder 103. A piston 105
has a piston rod 106, loaded by spring 109, that is connected to
and cocked by a cocking pin 107 mounted on a constantly driven
wheel 108 driven by the same type micro power and timing source 24
previously mentioned, e.g. an Accutron movement, fixed to a base
111 threadably secured to a cover 112.
In the third embodiment of FIGS. 6, 7 and 8, it will be understood
that bladder 80 is refilled when depleted. However, the pump-valve
unit 82 operates continuously and is limited only by the battery
life of the power source 24. Thus, increments of liquid can be
dispensed on some predetermined time schedule according to the
particular design of cocking mechanism and subject to maintaining
bladder 80 filled can be dispensed over a relatively long period of
time. Tube pinching devices or other devices for controlling flow
through lines 81 and 83 could be operated by a micro power source
and used instead of the pump-valve unit 82. Furthermore, the
patient, e.g. the addict or psychiatric patient, such as a
schizophrenic patient, is not required to have control over the
medication in that this device can insure a steady supply of the
drug internally with such a device. With such device these patients
could realize their full potential and become useful members of
society. In all prior art devices there has been virtually no way
to insure treatment of such patients on an out-patient basis
because such patients are often negligent in meeting medical
appointments and taking their regular medication. Considering the
scope of the problem, it can be seen that the present invention
opens up an entirely new method of treating and dispensing
medication. Examples of medication deemed suited to the invention
include cyclazocine in powder and liquid form for addicts,
stelazine in powder form for psychiatric patients and methadone and
naloxone in liquid form for addicts.
In the first and second embodiments illustrated by FIGS. 1-8, it
will of course be appreciated that in order to save time during
reimplantation procedures the wheel medication storage members 25
and 50 can be prefilled and held in inventory as spares. During
reimplantation, the full spare storage member can then be
substituted for the empty storage member and used with the other
parts of the device being reimplanted. Thus, both battery
replacement and medication replacement become relatively
inexpensive and easy to accomplish during the reimplantation
procedure.
While primarily intended for medical purposes and applications it
is contemplated that other applications will reveal themselves
where it is necessary to have an unattended micro size and micro
powered timing and dispensing apparatus. Thus, such broader
applications are contemplated by the invention.
It is contemplated that the sealing means shown in the drawings may
require modification for some applications where the device is in a
high moisture or high fluid environment. Thus, the piston mechanism
may require a form of sealing in such applications.
It should also be noted that the term "body" and "animal body" as
used in the claims are intended to include animal, human and other
living bodies. Further, the term "body" is intended to encompass
any environmental body, whether living or otherwise adapted to
receiving a self, micro powered and timed device for incremental
dispensing of substances into such body.
* * * * *