U.S. patent number 3,894,538 [Application Number 05/386,058] was granted by the patent office on 1975-07-15 for device for supplying medicines.
This patent grant is currently assigned to Siemens Aktiengesellschaft. Invention is credited to Gerhard Richter.
United States Patent |
3,894,538 |
Richter |
July 15, 1975 |
Device for supplying medicines
Abstract
A device for supplying medicines or the like to the body of man
or beast has a container for preserving a medicine as well as means
for changing the volume of the container. The container has an
opening through which the medicine is ejected when the volume of
the container is diminished. The invention is particularly
characterized by the provision of another container operatively
joined to the first-mentioned container and having a variable
volume for varying the volume of the first-mentioned container. The
change in volume of the other container is produced by gas or
liquid particles diffused or entering through electrical fields or
by electrolytical gas development within the container.
Inventors: |
Richter; Gerhard (Erlangen,
DT) |
Assignee: |
Siemens Aktiengesellschaft
(Munich, DT)
|
Family
ID: |
5853263 |
Appl.
No.: |
05/386,058 |
Filed: |
August 6, 1973 |
Foreign Application Priority Data
|
|
|
|
|
Aug 10, 1972 [DT] |
|
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2239432 |
|
Current U.S.
Class: |
604/891.1;
424/424; 204/627; 222/95 |
Current CPC
Class: |
A61M
5/14276 (20130101); A61M 5/155 (20130101); A61M
2005/14204 (20130101) |
Current International
Class: |
A61M
5/145 (20060101); A61M 5/155 (20060101); A61M
5/142 (20060101); A61m 031/00 () |
Field of
Search: |
;128/171.1,127-131,260,272,2.1E,2R,213,2.1R,218R,261
;222/56,57,193,95 ;204/195R,195P,301 ;3/1 ;310/2 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Attorney, Agent or Firm: Scher; V. Alexander
Claims
I claim:
1. A device for supplying medicines to the body of man or beast,
comprising means forming a first container of variable volume for
containing a medicine and having an opening for delivery of
medicine, means connected with the first-mentioned means and
forming a second container of variable volume to vary the volume of
the first-mentioned container, and means supplying volume varying
means to the second mentioned container said volume varying means
for said second container having a diaphragm window for receiving
said volume varying means having two electrodes of different
potentials and located on opposite sides of said diaphragm window
and being embedded between said electrodes to provide a current or
voltage supply for producing electrical fields so that fluid
particles are transmitted into said second container in an
electro-osmotic manner.
2. A device in accordance with claim 1, wherein said volume varying
means comprise means electrolytically developing gas in the
second-mentioned container.
3. A device in accordance with claim 2, wherein the first-mentioned
and the second-mentioned means jointly constitute a rigid casing
having a separating wall dividing the interior of said casing into
the first-mentioned container and the second-mentioned container,
said separating wall pressing into the first-mentioned container
when the second-mentioned container receives an excess of said
volume varying means.
4. A device in accordance with claim 1, wherein the diaphragm
window of the second-mentioned container is semipermeable and
consists of a substance selected from the class consisting of
hydrophobic material, hydrophilic material, porous teflon,
non-porous teflon, polyethylene, silicon, cellulose, cellulose
derivatives and ion exchangers.
5. A device in accordance with claim 1, wherein said diaphragm
window consists of electrically charged material transmitting
water, steam and ions, said electrodes producing current of such
polarity that water is transmitted into the second-mentioned casing
in an electro-osmotic manner.
6. A device in accordance with claim 5, having means supplying a
current to said electrodes and having a potentiometer varying the
extent of this current.
7. A device in accordance with claim 5, wherein said electrodes are
current producing electrodes and consist of a combination of a
metallic electrode as anode of zinc, cadmium or aluminum with a
silver/silver chloride or oxygen/carbon electrode as cathode or a
combination of a selective oxygen electrode and a glucose
electrode.
8. A device in accordance with claim 2, wherein means
electrolytically developing gas comprise a precious metal inert
electrode and a counter electrode selected from the class
consisting of a silver/silver chloride electrode and a zinc
electrode.
9. A device in accordance with claim 8, comprising an electronic
steering and regulating device for steering and regulating the
current between said electrodes depending upon measured value
signals received from the body, said signals producing a measure
for the size of the body to be influenced by the medicine.
10. A device in accordance with claim 3, wherein said casing
consists of a substance impermeable to liquid and having at least
an outer surface adaptable to tissue for transplanting it into a
body.
11. A device in accordance with claim 1, comprising a plug closing
said opening and consisting of a finely porous material.
12. A device in accordance with claim 11, wherein the pores of said
material range between 1 .mu. and 20 .mu. and are less than 100
.mu..
13. A device for supplying medicines to the body of man or beast,
comprising means forming a first container of variable volume for
preserving a medicine and having an opening for delivery of
medicine, means connected with the first-mentioned means and
forming a second container of variable volume for varying the
volume of the first container, and a device supplying volume
varying means to the second container, said volume varying device
comprising a diaphragm window for said second container, which
consists of electrically charged material transmitting particles,
such as of water, steam and ions, and further comprising at least
two electrodes located on opposite sides of said diaphragm window,
said diaphragm window being embedded between said electrodes, said
electrodes comprising a current or voltage supply for producing
current of such polarity between such electrodes, that particles,
such as of water, are transmitted into the second container in an
electro-osmotic manner.
14. A device in accordance with claim 13, wherein the diaphragm
window of the second container is semipermeable and consists of a
substance selected from the class consisting of hydrophilic
material, such as cellulose, cellulose derivatives and ion
exchangers.
15. A device in accordance with claim 13, said current or voltage
supplying means comprising a device, such as a potentiometer, for
varying the extent of current between electrodes.
16. A device in accordance with claim 13, wherein said electrodes
are current producing electrodes and consist of a combination of a
metallic electrode as anode of zinc, cadmium or aluminum with a
silver/silver chloride or oxygen/carbon electrode as cathode.
17. A device in accordance with claim 13, wherein said electrodes
are current producing electrodes and consist of a combination of a
selective oxygen electrode and a glucose electrode.
18. A device in accordance with claim 13, wherein said electrode
current or voltage supply comprises an electronic control device
for controlling current between said electrodes depending upon
measured value signals received from the body, said signals
producing a measure for a variable quantity or parameter inside the
body to be influenced by the medicine.
19. A device in accordance with claim 18, wherein said variable
quantity or parameter is glucose inside said body and said medicine
preserved by said first container is insulin.
20. A device in accordance with claim 13, comprising a plug closing
said opening in said first container for delivery of medicine and
consisting of a finely porous material, wherein the pores of said
material range between 1 .mu.m and 20 .mu.m.
Description
This invention relates to a device for supplying medicines or the
like to the body of man or beast, having a container for preserving
a medicine as well as means for changing the volume of the
container. The container has an opening through which the medicine
is ejected when the volume of the container is diminished. The term
"medicine" as used herein is intended to cover all substances which
are used to improve, reinstate or maintain the health of a patient,
such as for example, vitamins or hormones.
During many illnesses the patients must be provided with medicines
for lengthy time periods, for example, insulin for diabetes,
corticosteroides for rheumatic illnesses, cytostatics for cancer,
blood pressure regulators or also sex hormones. Up to now the
supply of these medicines to the body of the patient took place
primarily either orally (by swallowing tablets) or by simple
injection at certain time intervals. Thus this supply of medicines
is a discontinuous one and is poorly adapted to the actual
requirements of the patient. When the patient provides himself with
the medicines, the correct dosage is not always provided. However,
in case of many medicines a very precise dosage is most important,
since an excess of the medicine or insufficient dosage can have
detrimental effects. Thus, for example, an insufficient amount of
insulin causes comadiabetics, while an excess produces a
hypoglycaumic shock. A lack of precision in the dosing of insulin
probably causes an inclination of diabetics to
arteriosclerosis.
An object of the present invention is the provision of a device
which is operable without the assistance of a doctor or the use of
the patient for providing automatically for long time periods a
comparatively precise dosage of a medicine.
Other objects will become apparent in the course of the following
specification.
In the accomplishment of the objectives of the present invention it
was found desirable to operatively combine with the container of
the described type another container of variable volume serving as
means for varying the volume of the medicine-carrying container.
The change in volume of the second container is produced by gas or
liquid particles diffused or entering through electrical fields or
by electrolytical gas development within the container.
The regulation of the delivery of medicine out of the
medicine-carrying container by a change in volume of another
container operatively connected with the medicine-carrying
container, makes it possible to provide with the simplest technical
means an extremely precise dosage of the medicine being delivered
for long time periods, since volume changes of a container as such
can be continuously precisely produced in a simple manner and can
be controlled. The changes in volume actuated by gas or liquid
particles diffused or entering through electrical fields or by
electrolytical gas development, is particularly advantageous since
such flows have an extremely precise uniformity over long time
periods, so that changes in volume of the container regulating the
delivery of the medicine out of the medicine carrying container
also have a high extent of continuity over long time periods.
Furthermore, the dosage of the medicine can be made extremely fine,
since the gas or liquid diffused or field currents or
electrolytically produced gas currents causing the passage of
medicine out of the medicine-carrying container can be kept
extremely small by suitable shaping or measuring of the gas or
liquid diffusion passage or of the electrolytic gas developer in
the container.
In accordance with the present invention the medicine-carrying
container can be made totally or partly of elastic material and
means can be provided for transforming volume changes of the other
container into a compressing force exerted upon the elastic
material. The other container can press with at least a part of its
walls directly upon the elastic material of the medicine-carrying
container. For that purpose the medicine-carrying container is
preferably placed within the main container or so arranged that at
least the elastic part of the medicine-carrying container
constitutes at the same time a part of the wall of the main
container.
According to a preferred embodiment of the present invention the
main container has a rigid casing the interior of which is divided
by a separating wall into two chambers one of which has an outflow
opening and is used to receive the medicine, while the second one
has a diaphragm window through which gas or liquid particles can be
diffused or entered by electrical field action or which can contain
a gas producer for electrolytic gas separation, whereby the
separating wall can be pushed into the first chamber due to an
increase of gas or liquid in the second chamber. The diffusion or
entry of gas or liquid particles into the second chamber preferably
takes place either in the usual osmotic manner or in the
electro-osmotic manner.
While the normal osmotic diffusion effect permits substantially
only a dosage of the medicine to be used extending continuously
over the entire duration of the treatment, the electro-osmotic
effect as well as the electrolytic gas production in a further
container permit a medicine dosage which can be operated or
regulated from the outside to a certain extent, by setting currents
of different strengths between electrodes required for producing
the electro-osmotic effect or for electrolytic gas separation. The
operation or regulation of the dosage can take place preferably by
measure value signals which are obtained from or in the body of the
patient and constitute a measure for the size of the body to be
affected by the medicine.
The device of the present invention is paticularly suitable for
implantation into the body of a patient. However, it can be
obviously used outside of the body, for example, by being carried
upon the surface of the body.
The invention will appear more clearly from the following detailed
description, when taken in connection with the accompanying drawing
showing by way of example only, preferred embodiments of the
inventive idea.
In the drawing:
FIG. 1 is a section through an implantable device of the present
invention operating according to normal osmose.
FIG. 2 is a section through an implantable device of the present
invention operating according to electro-osmose.
FIG. 3 is a section through an implantable device of the present
invention wherein changes in volume of the container actuating the
medicine-carrying container are caused by gases produced
electrolytically in the container.
The casings are indicated by the numeral 1 in the drawing. The
casing 1 consists of a material which does not transmit liquid and
is well adapted to tissue, for example, epoxide resin.
The interior of the casing 1 is divided by a diaphragm 2 into two
separate chambers 3 and 4, whereby the chamber 3 is used for
receiving a medicine, for example, insulin for treating diabetes,
while chamber 4 serves for creating osmotic pressure as the result
of which the diaphragm 2 is slowly pressed into the chamber 3 and
thus by this extension presses the medicine located in the chamber
3 through an outflow opening 5 provided in the container. The
diaphragm 2 consists of a liquid-tight material, preferably a
plastic, and is elastic. It is also possible to additionally
metallize the diaphragm 2 as well as the interior of the
medicine-containing chamber 3 to provide greater impermeability
against liquids and to prevent possible chemical reactions of the
medicine with the material of the casing or diaphragm.
The liquid medicine driven through the opening 5 is transported
through a thin tube 6 connected to the opening 5 to a suitable
location in the body of the patient, for example, into the blood
flow, and is there released. The free end of the tube 6 is
preferably provided with a finely porous plug 7 which prevents
return diffusion of the body liquid into the medicine-containing
chamber 3 or an uncontrolled outflow of the medicine out of the
chamber 3. The plug can consist of porous teflon or a hydrophylic
material, such as cellulose, or an ion exchanging material. The
width of the pores of the plug material should be less than
100.mu.m, preferably between 1 and 20.mu.m.
In the embodiment illustrated in FIG. 1 the creation of osmotic
pressure in the chamber 4 takes place in a normal osmotic manner.
For that purpose the wall of the chamber 4 is provided with a
diaphragm window 8 consisting of a semi-permeable material which
can transmit water or steam, and also small loose molecules or
ions, but not the substance located within the chamber 4 and used
to build up osmotic pressure in the chamber.
The window 8 can be either rigid or can be held by porous rigid
supports preventing it from moving outwardly when pressure is
increased. The material of the diaphragm can be either a
hydrophobic material, for example, porous or also nonporous teflon,
polyethylene or silicon, or the diaphragm can consist of a
hydrophilic material, for example, cellulose, cellulose derivatives
or ion exchangers. If porous teflon is used as the diaphragm
material, then the width of its individual pores must be narrower
than the width of the pores of the material of the plug located at
the outlet of the medicine transmitting tube 6.
To make certain that there will be a uniform and fine outflow of
the medicine out of the chamber 3, the steam pressure in the
chamber 4 must be small relatively to steam pressure in the body
liquid surrounding the casing 1. Furthermore, changes of steam
pressure in the pressure chamber must remain small during the
operational period, compared with the steam pressure difference
relatively to body liquid. The dosage of the medicine is then
determined by the extent of diffusion of water or steam in the
chamber 4. The extent of transmission of the semipermeable window
8, its size and thickness are to be selected depending upon the
desired dosage. A hygroscopic salt, such as magnesium-, zinc- or
calcium chloride, is suggested as a substance with low steam
partial pressure for the interior of the chamber 4.
If a material is selected for the diaphragm window which transmits
ions, then the interior of the chamber 4 should be filled with a
polyelectrolite or a gel. The osmotic pressure is then produced due
to a so-called Donnan weight balance.
In the construction shown in FIG. 2 osmotic pressure in the chamber
4 is produced by an electro-osmotic effect. For that purpose the
wall of the casing of the chamber 4 is provided with a diaphragm
window 9 which is electrically charged and transmits ions. The
window 9 is fixed between two electrodes 10 and 11 which produce a
current through the window. The electrodes must be so polarized
that counter ions move inwardly through the window to the solid
ions, namely in the direction toward the chamber 4. If, for
example, the window has cation exchange properties, then the
electrode 10 must be polarized negatively and the electrode 11 must
be polarized positively. When the electrodes 10 and 11 lie directly
upon both sides of the window 9, they must be also made porous and
filled with an electrolite, so that the electro-osmotic
transportation of water through them can take place. Furthermore,
the electrode 11 should be screened by a diaphragm 12 transmitting
ions and suitable for tissue to avoid its contact with bodily
tissue.
The electrodes 10, 11 can be supplied with outside current, for
example, by a battery 13 through a potentiometer 14 which can be
connected by outlet contacts 15 and 16 with the current connecting
contacts 17 and 18 of the electrodes 10 and 11. If the electrodes
consist of an inert material, such as platinum, then care must be
taken that the feeding current should not exceed the amount of 1
mA/cm.sup.2, so that no gas development should take place
(diffusion limit current).
However, the electrodes 10 and 11 can be advantageously so
constructed that they themselves will supply the current. For that
purpose an electrode consisting for example of zinc, cadmium,
aluminum or glucose can be used as anode and as cathode can be a
silver/silver chloride or an oxygen/carbon electrode. In case of a
combination of a glucose electrode with an oxygen electrode, the
glucose electrode which, for example, consists of platinum black or
Raney-platinum-ruthenium, must be applied to the side facing the
chamber 4 of the hydrophilic window constructed as anion exchanger
(electrode 10). The oxygen electrode consists of porous charcoal
and is located upon the outer side of the window 9 (electrode 11).
Since the coal electrode is selective and reacts only with oxygen,
the glucose is diffused without hindrance through the coal
electrode and the window 9 to the non-selective precious metal
electrode and can be reacted there. When a resistance 19 is
connected, -- preferably a potentiometer for setting different cell
currents, -- a current will flow between the electrodes.
The use of device devide of the present invention having a
glucose-oxygen-electrode combination is particularly advantageous
when as medicine insulin is to be supplied to diabetics. Since in
such combination the current between the electrodes is also
directly dependent from the glucose content of the tissue liquid of
the patient, a more or less strong current corresponding to the
height of the blood glucose mirror is produced in a time unit
through the window, and thus more or less water is diffused in the
same time period into the chamber 4 and thus due to a more or less
quick filling of this space 4 a correspondingly strong or less
strong insulin is transmitted through the opening 5 and tube 6 to
the blood of the patient. Thus a device of this type carries out
already by itself a certain regulating function with respect to an
increased insulin delivery at a higher glucose mirror and a
correspondingly weaker insulin delivery at a correspondingly lower
glucose mirror.
However, even when other types of medicine are used it is possible
to operate or regulate a corresponding adaptation of medicine
delivery to the momentary requirement of the patient, by providing
means which continuously supervise the body section to be
influenced by the medicine and produce corresponding measuring
signals which can be then used for operating or regulating the
electrode current, for example, by correspondingly actuating the
potentiometer 14 or 19. In case of a regulation as intended value
is then used a normal value of the body size and the medicine
delivery is regulated on the basis of body size signal-actual
value-intended value deviation (over the current).
The amount of medicine which should be transmitted from the
medicine container 3 into the tissue or blood of a patient
corresponds to the amount of solution (water and ions) which is
transmitted through the diaphragm window 8 or 9 into the chamber 4.
In the embodiment of the invention illustrated in FIG. 2 this
amount of solution and thus the delivered amount of medicine are
determined directly by the strength of electro-osmotically
actuating current. For example, per Faraday (96500 As) are
transported by a cation exchange diaphragm at a current strength of
1 mA/cm.sup.2 50 mol of solution (corresponding to 90 gr.). Thus
the delivery of 1 ml medicine requires about 100 As. If this amount
of medicine is to be delivered within 24 hours, an electrode
feeding current of about 1.25 mA is required.
In the embodiment shown in FIG. 3, as distinguished from those of
FIGS. 1 and 2, the deviation of the diaphragm 2 does not take place
by osmotic pressure in chamber 4, but a gas is produced
electrolytically in chamber 4, which with increased volume moves
the diaphragm 2 correspondingly into the medicine space 3. The
electrolytic gas producer consists simply of an inert electrode 20
for gas separation, for example, a precious metal electrode
(platinum), as well as a counter electrode 21 (silver/silver
chloride or zinc electrode). Between the electrodes 20, 21 a fixed
electrolite 22 is located. The current feeding of the electrodes
takes place through the battery connections 23 and 24.
Contrary to the embodiments of FIGS. 1 and 2, the movable diaphragm
2 of FIG. 3 is not flat but is partially folded. However, this
difference is only a variant of the diaphragm construction of FIGS.
1 and 2 and has no significance for the basic working principle of
the device of the present invention.
As shown in FIGS. 1 and 2, two narrow conically outwardly extending
bore holes 25, 26 are provided for filling medicine in the medicine
containing chamber 3 and for emptying liquid or gas in the chamber
4, the holes being closed by spring valves 27 and 28.
For example, a precisely fitting also conical injection needle is
introduced into this opening 25 or 26, which then opens
automatically the valve 27 or 28 and by means of which the medicine
container chamber 3 can be filled again or gas or liquid can be
removed from the chamber 4.
During refilling with medicine necessarily small pressure
differences take place in the chamber 3. To avoid an outflow of
medicine from the outlet opening 5 or a suction of the body liquid,
for example, a valve can be provided in the tube 6, which closes
the outflow opening at the same time as the filling valve 27 is
opened. Since the outflow opening is to be made as a narrow
capillary, only small amounts of medicine which are within
permissible tolerance limits can flow out during the refilling
procedure due to variations in pressure.
* * * * *