DEVICE FOR AT LEAST TEMPORARY OCCLUSION OF BODY CHANNELS

DISPOSITIF POUR L'OCCLUSION TEMPORAIRE OU PERMANENTE DE CONDUITS DE L'ORGANISME

English Abstract

274.40 TH/AB
978-01-10

ABSTRACT OF DISCLOSURE

The present invention relates to a device for temporary or per-
manent occlusion of channels or hollow spaces in human or animal bo-
dies, particularly oviducts and spermatic ducts. According to the
invention the device consists of a body made of a material, which,
when brought into contact with a body fluid, swells at least 20%. In
other respects, the material should be essentially inert and harmless
to the body fluid and surrounding tissues and should not be absorbed
by the human body. Suitable materials for this purpose are hydrogels.
In use the body is introduced into a channel in the unswollen
state and will thereafter swell, when in contact with the body fluid,
so that the body, which can pass through the channel when inserted,
will swell and effectively contact the walls of the channel occluding
the same, simultaneously with the body being anchored in position.

Claims

CLAIMS
1. A device for at least temporarily occluding channels such
as oviducts or spermatic ducts in human beings and animals, said
device comprising a body, adapted to be inserted into a respective
channel, wherein the body consists of a material which swells at
least 20% when in contact with body fluid, and which is essential-
ly inert to body fluid and surrounding tissues.
2. A device according to claim 1 , wherein the material swells
at least 40% and preferably at least 80% when in contact with body
fluid.
3. A device according to claim 1 , wherein said material con-
sists of a hydrogel.
4. A device according to claim 2 , wherein said material con-
sists of a hydrogel.
5. A device according to claim 2, 3, or 4, wherein the
hydrogel is of acrylic type.
6. A device according to claim 2 or 3, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional meth-
acrylates.
7. A device according to claim 3 or 4, wherein the hydro-
gel is a copolymer of at least one hydrophilic monomer and at
least one hydrophobic monomer.
8. A device according to claim 2, 3 or 4, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer.
9. A device according to claim 2, 3 or 4, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer.
10. A device according to claim 2, 3 or 4, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with the polyfunctional
methacrylates, the ester moiety of the methacrylic ester
being derived from a polyhydric alcohol.


11. A device according to claim 3 or 4, wherein the hydro-
gel is a copolymer of at least one hydrophilic monomer and at
least one hydrophobic monomer, and wherein the ester moiety of
the methacrylic ester is derived from a polyhydric alcohol.
12. A device according to claim 2, 3 or 4, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer, the ester moiety of the methacrylic ester being
derived from a polyhydric alcohol.
13. A device according to claim 2, 3 or 4, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer, the ester moiety of the methacrylic
ester being derived from a polyhydric alcohol.
14. A device for at least temporarily occluding channels
such as oviducts or spermatic ducts in human beings and animals,
said device comprising a body containing an X-ray opaque
material, said body being adapted to be inserted into a respect-
ive channel, wherein the body consists of a material which
swells at least 20% when in contact with body fluid, and which
is essentially inert to body fluid and surrounding tissues.
15. A device according to claim 14, wherein the material swells
at least 40% and preferably at least 80% when in contact with body
fluid.
16. A device according to claim 14, wherein said material con-
sists of a hydrogel.
17. A device according to claim 15, wherein said material con-
sists of a hydrogel.
18. A device according to claim 15, 16 or 17, wherein the
hydroqel is of acrylic type.
19. A device according to claim 15, 16 or 17, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional meth-
acrylates.




20. A device according to claim 15, 16 or 17 wherein the hydro-
gel is a copolymer of at least one hydrophilic monomer and at
least one hydrophobic monomer.
21. A device according to claim 15, 16 or 17 wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer.
22. A device according to claim 15, 16 or 17, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer.
23. A device according to claim 15, 16 or 17, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with the polyfunctional
methacrylates, the ester moiety of the methacrylic ester
being derived from a polyhydric alcohol.
24. A device according to claim 16 or 17, wherein the hydro-
gel is a copolymer of at least one hydrophilic monomer and at
least one hydrophobic monomer, and wherein the ester moiety of
the methacrylic ester is derived from a polyhydric alcohol.
25. A device according to claim 15, 16 or 17, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer, the ester moiety of the methacrylic ester being
derived from a polyhydric alcohol.
26. A device according to claim 15, 16 or 17, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer, the ester moiety of the methacrylic
ester being derived from a polyhydric alcohol.



27. A device for at least temporarily occluding reproduction
ducts such as oviducts or spermatic ducts in human beings and
animals, said device comprising a body containing an X-ray
opaque material, said body being adapted to be inserted into a
respective channel, wherein the body consists of a material
which swells at least 20% when in contact with body fluid,
and which is essentially inert to body fluid and surrounding
tissues, an indicator thread being operatively secured to the
body.
28. A device according to claim 27, wherein the material swells
at least 40% and preferably at least 80% when in contact with body
fluid.
29. A device according to claim 27, wherein said material con-
sists of a hydrogel.
30. A device according to claim 28, wherein said material con-
sists of a hydrogel.
31. A device according to claim 28, 29 or 30, wherein the
hydrogel is of acrylic type.
32. A device according to claim 28, 29 or 30, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional meth-
acrylates.
33. A device according to claim 29 or 30, wherein the hydro-
gel is a copolymer of at least one hydrophilic monomer and at
least one hydrophobic monomer.
34. A device according to claim 28, 29 or 30, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer.
35. A device according to claim 28, 29 or 30, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer.




36. A device according to claim 28, 29 or 30, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with the polyfunctional
methacrylates, the ester moiety of the methacrylic ester
being derived from a polyhydric alcohol.
37. A device according to claims 29 or 30, wherein the
gel is a copolymer of at least one hydrophilic monomer and at
least one hydrophobic monomer, and wherein the ester moiety of
the methacrylic ester is derived from a polyhydric alcohol.
38. A device according to claim 28, 29 or 30, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer, the ester moiety of the methacrylic ester being
derived from a polyhydric alcohol.
39. A device according to claim 28, 29 or 30, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer, the ester moiety of the methacrylic
ester being derived from a polyhydric alcohol.
40. A device for at least temporarily occluding reproduction
ducts such as oviducts or spermatic ducts in human beings and
animals, said device comprising a body containing an X-ray
opaque material, said body being adapted to be inserted into a
respective channel, wherein the body consists of a material
which swells at least 20% when in contact with body fluid, and
which is essentially inert to body fluid and surrounding
tissues, an X-ray opaque indicator thread secured to the body.
41. A device according to claim 40, wherein the material
swells at least 40% and preferably at least 80% when in contact
with body fluid.
42. A device according to claim 40, wherein said material
consists of a hydrogel.
43. A device according to claim 41, wherein said material
consists of a hydrogel.


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44. A device according to claim 41, 42 or 43 wherein the
hydrogel is of acrylic type.
45. A device according to claim 41, 42 or 43 wherein
said hydrogel is a copolymer of methacrylic esters having at
least one hydroxy radical in the side chain with polyfunctional
methacrylates.
46. A device according to claim 42 or 43, wherein the
hydrogel is a copolymer of at least one hydrophilic monomer
and at least one hydrophobic monomer.
47. A device according to claim 41, 42 or 43, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer.
48. A device according to claim 41, 42 or 43 wherein the
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with Polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer.
49. A device according to claim 41, 42 or 43 wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with the polyfunctional
methacrylates, the ester moiety of the methacrylic ester
being derived from a polyhydric alcohol.
50. A device according to claim 41, 42 or 43 wherein said hydro-
gel is a copolymer of at least one hydrophilic monomer and at
least one hydrophobic monomer, and wherein the ester moiety of
the methacrylic ester is derived from a polyhydric alcohol.
51. A device according to claim 41, 42 or 43, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer, the ester moiety of the methacrylic ester being
derived from a polyhydric alcohol.
52. A device according to claim 41, 42 or 43, wherein the
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer, the ester moiety of the methacrylic
ester being derived from a polyhydric alcohol.

53. A device for at least temporarily occluding oviducts
of a woman, said device comprising a generally cylindric,
elongated body about 10 mm long and about 1-2 mm in diameter,
said body being adapted to be inserted into a respective
oviduct, wherein the body consists of a material which swells
at least 20% when in contact with body fluid, and which is
essentially inert to body fluid and surrounding tissues.
54. A device according to claim 53, wherein the material
swells at least 40% and preferably at least 80% when in
contact with body fluid.
55. A device according to claim 53, wherein said material
consists of a hydrogel.
56. A device according to claim 54, wherein said material
consists of a hydrogel.
57. A device according to claim 54, 55 or 56, wherein the
hydrogel is of acrylic type.
58. A device according to claim 54, 55 or 56, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates.
59. A device according to claim 55 or 56, wherein the
hydrogel is a copolymer of at least one hydrophilic monomer
and at least one hydrophobic monomer.
60. A device according to claim 54, 55 or 56, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer.
61. A device according to claim 54, 55 or 56, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer.
62. A device according to claim 54, 55 or 56, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with the polyfunctional
methacrylates, the ester moiety of the methacrylic ester
being derived from a polyhydric alcohol.

11

63. A device according to claim 55 or 56, wherein the hydro-
gel is a copolymer of at least one hydrophilic monomer and at
least one hydrophobic monomer, and wherein the ester moiety of
the methacrylic ester is derived from a Polyhydric alcohol.
64. A device according to claim 54, 55 or 56, wherein the
hydrogel is of acrylic type, is a copolymer of methacrylic
esters having at least one hydroxy radical in the side chain
with polyfunctional methacrylates and is a copolymer of at
least one hydrophilic monomer and at least one hydrophobic
monomer, the ester moiety of the methacrylic ester being
derived from a polyhydric alcohol.
65. A device according to claim 54, 55 or 56, wherein said
hydrogel is a copolymer of methacrylic esters having at least
one hydroxy radical in the side chain with polyfunctional
methacrylates, the hydrogel being a copolymer of at least
one hydrophobic monomer, the ester moiety of the methacrylic
ester being derived from a polyhydric alcohol.

12

Description

7~l
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Device for at least temporary occlusion of body channels
. .
Tne present invention relates to a device for temporary or per-
manent occlusion of channels or hollow spaces in human or animal bo- -
dies, particularly o~iducts and spermatic ducts.
Human and animal bodies contain a vast number of channels through
which fluid and/or other substances or objects can pass or be ~rans-
ported. In certain cases, it is desirable to disrupt such a passage.
Fo~ c^ntraceptive purposes the sperm~tic ducts and the oviducts ~fal-
lopian tubes) could thus be occluded, whereby the passage of ova and
sp~rms is prevented. In certain vascular diseases, for instances, it
~y be desïrable-to stop the flow of blood through certain blood vessels.
Tnis is possible both on arterial and vein side of the circulation.
The methods hitherto used for this purpose have had disadvantages such
as, for instance, that the passage through the channel has been diffi-
cult to occlude completely and/or to reopen, when desired. The means
used for this purpose have brought problems of fitting; in the case
of contraceptive devices such as described in the British Patent Spe-
cification No. 1 460 077 there have been problems in proYiding an
occlusion of the current size.
The object of the invention is to provide a device by means of
which the disadvantages mentioned aboYe are eliminated which device
will make it possible to occlude biological channels in a safe way by
adapting of the device to the size of the channel.
Another object of the present invention is ~o provide a de~ice
o~ the art mentioned which is possible to remove from the biological
channel in-which is has been inserted.
The objects of the inYention are obtained by means of a deYice
which is constituted by a body of a material, which, when brought into
contact with the~body fluid, swells at least 20~ and which is essential-,
ly inert to the body fluids and to the surrounding tissues.
On the accompanying drawing an embodiment of the invention and




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7~
its application are shown. In the drawing
Fig. 1 shows a partially sectional view through the oviducts of
a woman including the uterus and o~aries and showing devices according
to the invention inserted in the oviducts;
Fig. 2 shows in an enlarged scale a transversal sectional view
of the device according to the invention and
Fig. 3 is a transversal view o said device.
As mentioned, said de~ice acco~ding to the invention is consti-
tuted of a body of a ma~erial, which, when brought into con~act with a
body fluid, swells at least 20%. Apart from this swelling, the body
is ~o be essentially inert to the body fluid and to other surrounding
tissues. This swelling of the body in contact with body fluid is pre~
ferably at least 40~, e.g. at least 80~. It could be varied between
20 and 300% counted as linear expansion. The channels in human beings
and animals, which can be occluded by this device are, for example,
blood vessels, urethers, spermatic ducts and oviducts.
The geometric form of the body is not critical and it can be es-
sentially cylindrical, spherical or eggshaped. However, it has pre-
ferably a circular cross-section in the section corresponding to that
of the channel to be occluded. This cross-section of the body is pre-
ferably so much smaller than the cToss-section of the channel that the
body can conveniently be introduced along the channel.
The device according to the invention is particularly suited
for use as a contraceptive device. In this use the body is inserted
into the spermatic ducts or the oviducts. The body is in this case
preferably attached to a thread in such a way that it can be withdrawn
normally without a surgical incision. This thread can be made of an
X-ray opaque material enabling localization of the position of the
body.
The body itself can also possibly contain substances providing
X-ray contrast.
- When in contact with the body fluid the material of the body
swells at least 20~o~ preferably at least 40~0, e.g. at least 80%, and
may even swell as much as 300~0. In other respects, the material should
be essentially inert and harmless to the body fluid and surrounding
tissues and should not be absorbed by the human body. Suitable mate-
rials for this puTpose are hydrogels. These materials swell by ab-
sorbing water from the ~ody fluido Suitable hydrogels are polymers
and copolymers of acrylic type, as e.g. cross-linked polyacrylamide
and polymers and copolymers of methacrylic esters having at least~one


. .
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hydroxy radical in the side chain. ~ pre~erred monomer is 2-hydToxy-
ethyl-methacrylate or the monomethacrylate esters of di- or triethy-
lene glycol or 293-dihydroxypropane. As cross-linking agents, poly-
functional acrylates such as dies~ers or the same glycols, e.g. ethy-
iene glycol bis- methacrylate, are ~seful.
By choosing a copolymer consisting of a hydrophilic monomer and
a hydrophobic monomer the expansion ~actor and wa~er content can be
varied within wide limits by varying the ration between the hydrophi-
lic and the hydrophobic monomer. The swelling will increase if the
content of the hydrophile monomer is increased.
The body should be essentially elastic and plastic only to a
very small extent. In unswollen (non-hydrated) state it may be stiff
and/or hard (rigid), but should preferably soften in swelling. The
body can contain reinforcing material, e~g. armouring material, and
also material making it more ~-ray opaque, e.g. salts of barium or
bismuth.
In use the body is introduced into the channel in the unswollen
state and will thereafter swell, when in contact with the body fluid9
so that the body, which can pass through the channel when inserted,
will swell and effectively contact the walls of the channel. Through
the pressure then exerted by the walls on the body the elastic body
will be slightly compressed simultaneously with a possible expansion
of the elastic walls of the channel. Tn this way the body will fill
the whole cross-section of the channel and prevent anything from pas-
sing through the channel simultaneously with the body being anchored
in position. After insertion into an oviduct, the passage of ova to
the uterus and spermatozoa, respectively, upwards through the oviduct
to the unfertilized ovum will be prevented. After occlusion of a sper-
matic duct the outward passage of the spermatozoa will be prevented
and a good contraceptive action is achieved. If desired, the inserted
bodies can be withdrawn by operation or, as is the case when inserted
in an oviduct, by extraction through the uterus in the case where the
body is provided with an attached ~hread by which said extraction can
be performed.
A device 1 according to the invention and intended to be in-
serted in the oviduct of a woman is shown in a longitudinal sectional
view in Fig. 2. It is constituted of an elongated, cylindrical (com-
pare Fig. 3) body 2 of the mentioned expandable material with an inner
rounded end portion 3 and an outer ball shaped end portion 4. In the
body 2 is- included a thread made of an X-ray opaque material which

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2~ 71
terminates on a distance from the end of the inner end portion 3 and
which stretches out of the body at the end portion 4 with a free por-
tion 6.
In Fig. 1 is shown how the device l is inserted in the oviducts
7 of a woman. To the right is shown how the body 1 a shor~ moment af-
ter the insertion still keeps its original elongated, narrow shape,
which makes it easy to insert in the oviduct 7. To the left is shown
how the body 2 after a period in contact with the body tissues has
swelled by absorbing the body fluid completely occluding the channel
and obtaining a good anchoring to the same. The free portion 6 of the
thread 5 extends through the uterus 8 and makes an easy removal of the
the device possible and also makes it possible to control that the de-
vice remains in its intended place.
Examples of suitable dimension for the body 2 by the described
application are a length of 11 millimetres, the free portion of the
thread not included, and a largest diameter of 1,6 millimetres.
The body may alternatively be in the form of a drop with a dia-
meter of approximately 0,8 millimetre in the unswollen state.
The body 2 consists preferably of a hydrophilic monomer as po-
lyvinyl pyrrolidone and a hydrophobic ~onomer as an acrylate or poly-
amide by means of copolymerization (graft polymerization) at~ached to
the thread. The swelling and the water absorption power may be al-
tered bychanging the proportion of the hydrophilic and the hydrophobic
monomer to be polymerized. Three (3) parts o the hydrophilic monomer
(vinyl pyrrolidone) and one (1) part of the hydrophobic monomer (poly-
amide) forms a copolymer ha~ing an expansion fac~or of 1.48 linear
(swells 48~ in water) with a water content of 66~; five (5) parts of
the hydrophilic monomer and one (1) part of the hydrophobic monomer
forms a copolymer having an expansion factor of 1.72 wi~h a water con-
tent of 78%.
The thread 5 is preferably of polyamide fibre, made at least
partly X-ray opaque or provided with an X-ray opaque anchori~g element.
Even though the device according to the invention is described
in the form of a contraceptive, it is understood that other applica-
tions can be made, for instance, in case of brain damages, such as
cerebral haemorrhage, or when treating varicose veins, in which cases
a device according to the invention is inserted in the proper vessel to
completely obstruct said vessel. In such an application, the hour-
glass form is preferred.



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