U.S. patent number 3,865,108 [Application Number 05/377,350] was granted by the patent office on 1975-02-11 for expandable drug delivery device.
This patent grant is currently assigned to Ortho Pharmaceutical Corporation. Invention is credited to William L. Hartop.
United States Patent |
3,865,108 |
Hartop |
February 11, 1975 |
EXPANDABLE DRUG DELIVERY DEVICE
Abstract
A drug delivery device having a drug containing zone associated
with and partially defined by a material which swells on contact
with body fluids. When swelling occurs, the pressure on the drug
containing zone expels the drug from the device.
Inventors: |
Hartop; William L.
(Bernardsville, NJ) |
Assignee: |
Ortho Pharmaceutical
Corporation (Raritan, NJ)
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Family
ID: |
26841747 |
Appl.
No.: |
05/377,350 |
Filed: |
July 9, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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144174 |
May 17, 1971 |
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Current U.S.
Class: |
424/430; 424/434;
222/95; 424/436 |
Current CPC
Class: |
A61M
31/002 (20130101); A61K 9/0039 (20130101) |
Current International
Class: |
A61K
9/00 (20060101); A61M 31/00 (20060101); A61m
031/00 () |
Field of
Search: |
;128/260,127,130,268,215,216,253,213,2W,2R,1R,329,330,333,314,315,270,271,285
;222/92,95,206,103,105 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: Lambert; Benjamin F.
Parent Case Text
This is a continuation-in-part of co-pending application Ser. No.
144,174 filed May 17, 1971, now abandoned.
Claims
What is claimed is:
1. A device for the delivery of a medicament to a body cavity
comprising a base, said base at least partially defining a
medicament containing zone of restricted dimensions, said base
being expandable and incorporating a material which expands
sufficiently upon contact with body fluids to expand said base,
said material being selected from the group consisting of brown
algae, polysaccharides derived from brown and red seaweeds,
biosynthetic polysaccharides, natural gums, cellulose derivatives,
synthetic resins derived from cellulose, polyacrylamide,
polyvinylpyrrolidone, ethylene oxide polymers, and modified
starches, and said medicament containing zone being disposed in
pressure responsive relation to said expandable base such that upon
insertion of the device into a body cavity pressure is exerted on
the medicament containing zone as a result of resistance to
expansion by the base within the body cavity which causes the base
to compress the medicament containing zone resulting in the
medicament contained therein being dispensed into the body
cavity.
2. The device of claim 1 wherein said base is comprised of a
polymeric material and defines a hollow core which constitutes said
medicament containing zone.
3. The device of claim 1 wherein said expandable material is
Laminaria.
4. The device of claim 2 wherein said core contains a collapsible
capillary tube containing said medicament.
5. The device of claim 4 in which said capillary is of oval
cross-section.
6. The device of claim 1 in which a collapsible capillary tube
containing said medicament is disposed in fixed position adjacent
the surface of said base and the peripheral surface of said tube
defining an annular medicament containing zone.
7. The device of claim 4 in which said capillary contains an inner
rib along substantially its entire length.
8. The device of claim 4 in which the capillary contains a
plurality of inner ribs along substantially its entire length.
9. The device of claim 4 in which the capillary tube is of
rectangular cross-section.
10. The device of claim 6 in which said capillary contains an inner
rib along substantially its entire length.
Description
Current methods of introducing medicaments such as prostaglandins,
for example, into the uterine cavity for the purpose of abortion
and the like require the use of in-dwelling catheters and the
continual attention of medical personnel to deliver the drug by use
of a syringe or by hydrostatic pressure from an outside reservoir.
The device of this invention obviates the need for an in-dwelling
catheter and, more importantly, eliminates the need for an operator
to monitor the administration of the drug.
The device of this invention comprises a generally cylindrical or
prismatic base incorporating a substance which swells upon contact
with natural body fluids. The base of the device either defines a
hollow core containing a medicament or has disposed in a relatively
restrained position around or adjacent its outer surface a
medicament containing tube or sheath. In other words, the base at
least partially defines a medicament containing zone of restricted
dimensions. In either case, the medicament is dispensed into the
body cavity due to the pressure generated on the medicament
containing zone by virtue of the swelling of the base.
The invention may be better understood by reference to the attached
drawings, wherein
FIG. 1 is a longitudinal cross-section of a device of this
invention;
FIG. 2 is a vertical cross-section of the device of FIG. 1 taken
along lines 2--2;
FIG. 3 is a longitudinal cross-section of the device of FIGS. 1 and
2 after use;
FIG. 4 is a vertical cross-section of the used device of FIG. 3
taken along lines 4--4;
FIG. 5 is a longitudinal cross-section of another device of this
invention;
FIG. 6 is a vertical cross-section of the device of FIG. 5 taken
along lines 6--6;
FIG. 7 is a vertical cross-section of still another device of this
invention illustrating the same both before and after exposure;
FIG. 8 also is a vertical cross-section of another device of this
invention illustrating the same both before and after exposure;
FIG. 9 is a vertical cross-section of yet another device of this
invention illustrating the same both before and after exposure;
FIG. 10 is a view in perspective of still another device of this
invention;
FIG. 11 is a cross-section of the device of FIG. 10 taken along
lines 11--11;
FIG. 12 is a vertical cross-section of another device of this
invention;
FIG. 13 is a top view of another device of this invention;
FIG. 14 is a top view of yet another device of this invention.
FIGS. 1 through 11 illustrate embodiments of the invention wherein
the base of the device defines a hollow medicament filled core. The
device of FIGS. 1 and 2 consists of a base, 1, formed of a material
which will expand multi-directionally upon contact with body
fluids, the base defining a hollow core, 2. The hollow core, 2,
contains a medicament, 3, which is encased in a collapsible tube,
4, having a closed end, 5, projecting outward from the end, 6, of
the base, 1.
When in use, the end of the collapsible tube is severed and the
device inserted into a body cavity such as the cervix. The base, 1,
will expand multi-directionally upon contact with body fluid and
the resistance to expansion offered by the cervix causes the tube
to collapse and the medicament to be dispensed into the body
cavity. The cervical canal is gradually enlarged to accommodate the
increased dimensions. Thus, when used to dispense a medicament for
the termination of pregnancy, for example, the dilation of the
cervix will facilitate the abortion.
FIGS. 3 and 4 illustrate the device of FIGS. 1 and 2 after use. In
FIGS. 3 and 4, the capillary tube, 4, has been compressed and its
contents have been expelled into the uterine cavity.
While the device may be of any shape, it is preferred that it be
prismatic or cylindrical for enhancing comfort and facilitating
insertion. The device also preferably has a tail, 7, to assist in
its removal after use. It may also be advantageous to mold the base
of the device with an enlarged end portion, 8, to prevent the
device from accidentally being inserted completely into the uterus.
It is not practical to give a particular dimension for the device
since the size employed will depend upon whether the device is used
in the nostrils, vagina, for treating rectal disorders, etc.
The base of the device is made either primarily of a material which
will itself expand upon contact with body fluids, or is made of an
expandable material having incorporated therein a substance which
will expand upon contact with body fluids. By expandable material
is meant a material which will swell or expand beyond its original
or normal limits. Examples of such expandable materials include
brown algae, in particular species of the genus Laminaria;
polysaccharides derived from brown and red seaweeds, such as alkali
metal and ammonium salts of alginic acids and carrageenan;
biosynthetic polysaccharides such as xanthan gum; natural gums,
such as guar gum, karaya, tragacanth, psyllium seed, and locust
bean; cellulose derivatives such as microcrystallinecellulose;
synthetic resins derived from cellulose, such as
carboxymethylcellulose, and non-ionic cellulose gums such as
methylcellulose and hydroxypropyl cellulose; synthetic
water-absorbing polymers such as polyvinyl alcohol, polyacrylamide,
polyvinylpyrrolidone, and ethylene oxide polymers; and modified
starches such as pre-gelatinized corn starch. Preferred among the
expandable materials are those derived from brown algae and in
particular those derived from species of the genus Laminaria.
In practice, the capillary tube may be constructed of any thin,
easily collapsible metal or plastic material such as aluminum or
Teflon. The material must have sufficient strength to protect the
medicament during storage prior to use, but at the time of use must
be easily severable and collapsible. The collapsible tube, and the
hollow core, preferably have an oval cross-section to facilitate
collapse under pressure; however, any convenient shape may be
utilized.
In some cases, it may be desirable to encase the base in an outer
skin of highly flexible water-permeable material, 9a, such as is
illustrated in FIGS. 5 and 6. Such a skin assures that the device
will not break apart upon softening and swelling when in contact
with body fluids. It may be advantageous to form such a skin of a
material having a high modulus of elasticity so as to exert added
pressure on the medicament containing zone as the base attempts to
expand.
It is possible to further improve the operation of the device by
modifying the collapsible tube to prevent entrapment of the drug
due to irregular collapse of segments of the tube. Irregular
collapse can be avoided by molding a longitudinal rib, 10b, inside
the tube as shown in FIG. 7. Thus, the rib will allow passage of a
medicament on either side of it after the tube has collapsed. This
may also be accomplished by disposing ribs, 10c, at each side of
the tube as shown in FIG. 8. Irregular collapse may also be
overcome by providing a tube with a rectangular cross-section of
appropriate stiffness so that the short side walls, 11d, tend to
resist collapse and thus permit passage of the drug through the
spaces adjacent them as illustrated in FIG. 9.
While it was indicated at the outset that the device is preferably
cylindrical or prismatic, this does not mean that the base must be
formed of only one such solid. As illustrated in FIG. 10, the base
may be of any shape as long as it has smooth sides and corners, and
defines a hollow core into which the medicament or a capillary
containing the medicament may be inserted. The device of FIG. 10
consists of a series of four rods, 101, of a material which swells
when in contact with body fluids, arranged in a bundle so as to
leave an open core, 102, sufficient to hold a small capillary, 104,
containing the active drug, 103. The rods may be kept in their
illustrated configuration by an outer water-permeable covering,
109, such as the type previously described. The expansion of the
rods will fill the void occupied by the capillary and thus extrude
the contents into the body cavity.
A particularly adaptable substance for a device of this design is
the stalk of the seaweed of the Laminaria family which, when dried,
becomes rigid and bone-like. When exposed to water, the stalk will
increase in diameter nearly three-fold and become soft and
flexible.
As an example of the device illustrated in FIGS. 10 and 11, and the
manner in which it functions, four rods of Laminaria, each about
21/2 inches long and about 1/8 of an inch in diameter are bound
firmly together by means of fine copper wire. A catheter having an
inside diameter of 0.025 inches and an outside diameter of 0.047
inches is inserted longitudinally through the space between the
rods, is filled with a vegetable dye solution and one end is
clamped off. When the device is immersed in water, within 12
minutes the dye solution can be observed issuing from the open end
of the catheter. The dye continues to be expelled very slowly at
what appears to be a uniform rate for a total of one hour and 20
minutes. Calculations indicate that the rate of expulsion of the
dye cannot have exceeded 1 .times. 10.sup..sup.-3 ml. per minute.
This rate conforms to the concept of the delivery of very small
doses of highly active medicaments in a continuous fashion.
FIGS. 12 through 14 illustrate embodiments of the invention wherein
the base of the device has a medicament containing tube or sheath
disposed in a relatively restrained position around or adjacent its
outer surface. Referring specifically to FIG. 12, the base, 201, of
the device illustrated constitutes a solid core surrounded by
medicament, 203, encased in a sheath, 209. The sheath is not
permeable to fluids but the base absorbs body fluids through its
ends thus causing the desired effect.
Referring to FIG. 13, the medicament containing tube, 304, of the
device illustrated therein is helically wound around the base, 301,
and anchored by passing it through the base at either end, 310. As
the base expands, medicament is delivered through one of the ends,
310.
Finally, referring to FIG. 14, the medicament containing tube, 404,
of the device illustrated therein is secured adjacent to the
surface of the base, 401, by passing the same through the base at
either end, 410. As the base expands, medicament is delivered
through one of the ends, 410.
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