CA1152828A - Device for occlusion of bodychannels - Google Patents
Device for occlusion of bodychannelsInfo
- Publication number
- CA1152828A CA1152828A CA000351368A CA351368A CA1152828A CA 1152828 A CA1152828 A CA 1152828A CA 000351368 A CA000351368 A CA 000351368A CA 351368 A CA351368 A CA 351368A CA 1152828 A CA1152828 A CA 1152828A
- Authority
- CA
- Canada
- Prior art keywords
- portions
- channel
- cavity
- anchoring means
- thread
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
Abstract
ABSTRACT OF THE DISCLOSURE
Device for temporary or permanent occlusion of body channels or cavities in human or animal bodies and comprising a body of a material, which swells at least 20% by absorbing body fluid and which is substantially inert to the body fluid and the surrounding tissues. The body is dimensioned to be inserted into the channel or cavity with a play according to the surrounding walls in unswollen state of the body but to occlude the entire cross-section of the channel or cavity in swollen state thereby being anchored by means of pressure against the surrounding walls of the channel or cavity. The device comprises anchoring means attached to the body and comprising portions which at least in the unswollen state of the body in a determined way projects from the surface of the body.
The anchoring means are made of a material with such yielding properties that the means with said portions in a yielding way are pressed outwards against the surrounding walls to the channel or the cavity.
Device for temporary or permanent occlusion of body channels or cavities in human or animal bodies and comprising a body of a material, which swells at least 20% by absorbing body fluid and which is substantially inert to the body fluid and the surrounding tissues. The body is dimensioned to be inserted into the channel or cavity with a play according to the surrounding walls in unswollen state of the body but to occlude the entire cross-section of the channel or cavity in swollen state thereby being anchored by means of pressure against the surrounding walls of the channel or cavity. The device comprises anchoring means attached to the body and comprising portions which at least in the unswollen state of the body in a determined way projects from the surface of the body.
The anchoring means are made of a material with such yielding properties that the means with said portions in a yielding way are pressed outwards against the surrounding walls to the channel or the cavity.
Description
It has prior be~n su~gested to close body channels by means of bodies, which can swell. Such blocking of channels and cayities in human or animal bodies can be used of contra~
ceptive motives, the ovlducts or $permatic ducts then bei'ng occluded or causes' of a desease, wh~ch may require the blocking of a body channeI~
The swellable body in question has in the prior art been made'of fibrous substances', which swell when absorbing a body fluld, but it has no~ been' discovered that water-absorbing copolymer plastics, also called hydrogel compounds, are'appro-priate. The blocking is performed in such a manner that the swelling body in non-swollen condition is inserted into the body channel concerned. The form and dimensions of the body is adapted in such a way that it can easily be inserted into the channel. After its insertion it absorbs fluid from the surrounding tissued, which causes it to sweIl. The channel is thereby blocked, as was intended, and the body at the same time obtains a firm hold in the same. The material shall substantially be inert to the body fluid and to the surrounding tissues, so that the body will remain intact and can be removed when it has served its purpose. By means of such an arrangement one can by way of example restore the function of the oviducts or the spermatic ducts after blocking in preventive purpose.
~ owever, it has in practise turned out that there i<5 a risk that the body is carried out of the channel by a muscular movement or by being washed away during the first period after its insertion, when it has not yet had time to absorb so much body fluid that it has acquired such size that it has got a tight fit to the surrounding walls. In some connection such a dilatation of the channel can occur that the dimensions of the body no longer is sufficient resultin~ in a risk for expulsion.
It is an object of the present invention to eliminate said risk of expulsion out of the channel or displacement in the same.
- It is another object of the invention to provide a means, in which simple'measures are used to eliminate said risk in such a way that the body in its normal swel'lea-up condition without any special drawbacks works' ~n its normal function to occlude the'channeI~
X
~ 2'~S2~Z~3 In the' a;:companying drawings two embodiments of a body aocording to the invention and four embodiments of an element forming part of the device according to the invention are shown.
Fig. 1 in these drawings is a view of a longitudinal cross-section through the body accor~ing to the first embodiment; Fig. 2 shows the same body in a cross-sectional view; ~Fig. 3 shows the body according to the second embodiment in a longitudinal cross-section; Fig. 4 shows an element forming part of the body according to an embodiment, and Fig. 5 shows the element according to another embodiment.
The device accordirlg to the inventioi7 comprises, as mentioned, a body of a material, which, when brought into contact with a body ~luid, swells with respect to its volume at least by 20% measured as a linear expansion. ' Apart from the property to swell the body is substantially inert to thc body fluids and to the surrounding tlssues. The swelling of the body in contact with a bo-dy fluid is preferably at least 40% and for example at least 80%. The swelling' can vary between 20-300% in linear measure. The channel shaped cavities of human beings and animals, which can be blocked by means of th~ device accor-ding to the invention, ~re by way of e-xample blood vessels, urethra, spermatic ducts and oviducts.
The geometric shape of the body, whi~h is inserted into the conduit-shaped cavity, is not critical and the body can by way of exarnple essentially be cylindric, spherical, egg-shaped or of hour glass shape. It also suitably exhibits an essentially cylindric cross-sectian in the one cross-section corres-ponding to the cross-section of the channel or cavity. Said cross-section of the not y~t swelled body is so much smaller than the cross-section of the chan-nel that the body can be inserted into the channel with a play relative to lts walls, whereby the insertion can take plac~ with the least possible difficulty.
The means of the kind mentioned are especially suitable tor use as con-traceptive means, the body being inserted into the spermatic duct or the ovi-duct respectively. In the latter case a thread is preferably fastened to the bo-dy, so that it can be extracted without any operative incision. This thread can be made of a radiopaque material, sv that a control of the position of the body can be made. The body can alternatively in itself be made of X-ray contrasting material. The material of the body swells in contact with the body fluid by at least 40% suitably at least 80% and can even swell by so much as 300%. The rna-terial shall for the rest be essentially inert to the body fluid and shall not be harmful to or be absorbed by the body. Hydrogel compounds constitute a suit-able group of materials. Said mat~rials swell by absorbing water out o~ the bodyfluid. Suitable hydrogel compounds are polymers and copolymers of metacrylic -~a ' ~ .
, 3 ~ 2~3 acid esters with at least one hydroxy group in the lateral chain. A suitable mo-nomer is 2-hydroxy ethyl metacryiate, in which the ester group can be derived from diethylene glycol or triethylene glycol. 2,3-dihydroxy propyl metacrylate is by way of example also usefwl. As a cross linking compound such polyfunc-tional acrylates as diesters or corresponding glycols, ~r example ethylene gly-coi bis~metacrylate ca~l be used.
A copolymer of a hydrophilic monomer and a hydroFobic monomer consti-tute another example of materials suitable for the body according to the inven-tion. By means of varying the proportions between the hydrophilic and the hydrofobic monomer the property of water absorbtion and consequently the swel-ling of these materials be varied within wide limits. Monomers of the group com-prising N-vinyl pyrrolidones and vinyl pyridines can be mentioned as examples of the hydrophilic component, and monomers of the group comprising methyl acrylates and methyl metacrylates cen be mentioned as examples of the hydro-fobic component. A polymerisation suitably takes place by subjecting the star-ting materials to electromagnetic radiation in the ultravioiet-~amma radiation region or by heating.
The body shall essential!y be resilient and only to a very small extent be plastic. In non-swollen (not hydrated~ condition it can be stiff and/or hard,' but in the course of the swelling process it should soften. The body can con-tain substances, which makes it more radiopaque, by way of example salts of barium or bismuth or metal powder (silver3.
When the body is to be used, the same is inserted into the channel shaped cavity in non-swollen condition and thlereafter the body swells in con-tact with the body fluid, so that the body, which during its insertion can pass through' the channel swells and is brought into good contact with the walls thereof. By the pressure then exercised on the body by the walls, the resili-ent body is compressed at the same time as the elastic walls of the cavity pos-sibly are expanded. The body thereby fills out the whole cross-section of the cavity and impedes any passage through the ame at the same time as the body is well held in position inside the cavity. After inserting the body in for example an oviduct the passage of an egg down into the uterus and sperm cells up through the oviduct to the unfertilized egg respectively is impedecl. When occlu-ding a spermatic duct the passage of the sperm celi through the same is impe-ded, and a good preventive protection is obtained. The inserted bodies can according to wish again be removed by means of an operation, or, as is the case in connection with the insertion in the oYiducts, it can be drawn out to the uterus in those cases the body is provided with an adherent thread, by means of which the body can be pulled out.
:~, . . . . ..
4 ~ ~ S;~il21~
Thus, the body in its inserted position obtains a good anchoring in the body çhannel or in the cavity, in which it is inserted, after the body has ab-5nrbed body fluid and has swo!len. However, this requires some time, and be-fore so has taken place, the body exhibits a play relative to the surrounding tissue walls. The body in its non-swollen condition is, as mentioned, so much s,..aller than the ca~ity or -the channel that it easily can be inserted into the ~ody cavity in question. When the body has to be moved ~or a longer distance into the Ibody channel and also possibly may pass a section, which is narrower than the one, where the body is intended to be placed, it is necessary that body exhibits a considerable amount of undersize. The idea behind the de-.ce is also the one that the body, when the insertion takes place, shall exhi-it this smaller dimension but acquire the large dimension, which is necessary for a secure application and an efficient occlusion o~ the channel after the bo-dy's accomodation in the intended place.
However, if these conclitions'are fulfilled the body does not obtain any, secure anchcring until the swelling process has taken place, and therefore a period of insecurity arises immediately upon the insertion, when the body'under unfavourable circumstances can get displaced by body fluid flowing through the conduit or - by movements of the person accomodating the inser~ed body. This insecurity of function is, however, eliminated by means of the present inven-tion. ~he elimination takes place by providing the body with at least one se-curing means of a material of adjusted stiffness. This means exhibits outer parts, which at least in the non-swollen condition of the body project outside of the same, and'so far out 'that they arrive in; contact with the wails of the surrounding cavity, when the insertion of the body ~ has taken place in the de-sired manner. Thus, said projecting parts thereby serve as locking means, which wi th a spring ~orce hold the body in its inserted place. Said springing means are'suitably designed to exhibit such a lockin~ function that their !ocking action wil! be of low or no effect during the movement in the direction of inser-tion, but during an attempt to move the body out of the channel are effective by an expanding action.
Thus, the projecting parts of the means serve as anchoring means only or essentially before the body has acquired its swoiien condition. They can therefore exhibit such dimensions that the greater part of them will be inside the surface of the body, when they have acquired their swolien condition there-by being held in place. By this arrangement one avoids that the projecting parts in a too high degree are pressed in into the surrounding body tissue during the condition of permanency, when the body has acquired its swollen condition .
, .
~Lt;~2~
A device 1 according to the invention and intended for insertion in the ovidur-t ~f a woman is shown in a longitudinal cross-section in Fig. 1. It is forrnPd hy a long, cylindric (compare Fig. 2) body 2 of the swelling material mentiDned and exhibiting an inner, rounded-off end portion 3 and an outer ball-shaped end portion 4. A thread 5 is secured to the body 2 and preferably con-sists ^f nylon, said~thread terminating inside the inner end 3 but extending outside of the body at the end 4 exhibiting a free portion 6.
As an example of suitable dimensions o~ the body 2 in the application described a length of 11 mm with the exception of the free portion 6 of the thresd and a maximum diameter of 1,66 mm can be mentioned. The body can al-ternatively have the shape of a drop with a diameter of approximately 0,8 mm of .he small end of the non-swollen condition.
The thread 5 is preferably made of polyamide fibre and at least in part made impermeable byx-rays.
One or several means 7 for the anchoring of the body mentioned extend through the same and in the non-swoilen condition of the body 2 exhibit projec-ting portions 8. The mid portion 9I from which the outer parts 8 are projecting is located inside the material of the body 2 also in its non-swollen condition and thus, forms an anchoring of the means 7. Moreover the thread 5 extends through a hole 10 of the means 7, whereby an extraordinary anchoring of the means 7 and the thread 5 to the materlal of the body 2 is reciprocally obtained. The con-nection of the thread 5 and the means 7 is moreover advantageous, when the device 1 is manufactured, as only one element needs to be placed in the forming tool, and durinç~ the forming operation itself the parts in question can be heldby holding the projecting portions 8 vf the means 7, which portions project out-side of the very ~orming ohamber for the body 2. A good connection between the means 7 and the thread can be obtained, if the hole 1û as is hintecl ln Fig.2 is provided with portions 11, directed inwards and penetrating into the thread 5.
An alternative holdlng arrangement is shown in Fig. 4, where the thread 5 has been provided with knots 12 on both sides of the means 7.
In the embodiment of the means 7 illustrated in Figs. 1, 2 and 4 its two haives on the sides of the hole 10 form triangular wings forming an acute ang-le to each other. Said wings as is hinted in Fig. 4 are at least slightly concave on the one of their sides facing the other wing. The form and the thickness can however, be adapted to the material chosen and to the required spring force di-rected outwards. The intention is that the measure over the ends of the means 7 shall be somewhat larger than the inner measure for the intended body channel so that the means 7 is expanciing against its walls but ir~ a yielding manner sothat the outer portions 8 can fold inwards, if during the insertion a narrow , 6 ~ L~28z8 section is passed. By the yielding property an adaptation to different cross~
sections of the channels are in addition obtained.
The rnaterial of the means 7 must not have any harmful effect to the body of the person, in which the device is inserted. A somewhat semi-stiff springing plastic material such as acetal plastics or an amide is preferably used.
A device 13 is illustrated in 3 longitudinal cross-section in Fig. 3 and correspQnds to a second example of embodiment. This device is intended for insertion in the spermatic duct and its dimensions and its form is adapted t~ this purpose. It has a long cylindric shape of the length of for exampie 6 mm and a di..meter of approximately 0,6 mm, which, thus is valid for the non-swollen con-dition of the body made of swellable material and here indicated with 14.
The insertion in the spermatic duct cannot take place from outside, bu~
has to be performed by an operative incision, during which the spermatic duct is opened up, whereafter the device 13 can be inserted, the spermatic duct suhcequently being occluded. The non-swollen condition of the body 14 means that the body has smaller dimensions than the inner space of the spermatic duct becal~se of which the insertion is facilitated. After the insertion the body 14 swells by absorbing body fluid in accordance with what has been described in the ~oregoing. A removal of the device, if so desired, can take place also by means of an operative incision. It is therefore useless to provide the device with a thread, and besides to be able to control its p~sition i~y means of X-rays, the material of the body 14 shall be made of at least in part radiopaque material by way of example by metals or metal salts forming part of the same. Also the device 13 contains a means 15 for the anchorin~3 during its non-swoilen condi-tion. As was the case with the means 7 this one exhibits outer portions 16 swungout towards one end of the body 14, said portions 16 exhibiting a yielding pro-perty and a propensi$y to expand against the wall of the spermatic duct. The outer portions and the mid-portions 17, the latter by casting operation enclosedinside the body 14 are made in an open piece exhibiting a rod-shaped centre portion 18, which is used for the anchoring to the body 14. The means 15 will of course exhibit very small dimensions as the body 14, as mentioned, has a dia-meter of less than 1 mm.
An alternative form of the anchoring means is illustrated in Fig. 5. A
thread 19 of polyamide fibre is here utilized. This thread can be used in the same manner as the extractable thread 5 and thus, prsject outside of the swell-able body. However, it can also be so short that it only constitutes holdin~
means like ~e part 18. The projecting wings, which shall form the outer por-tions, are formed by coils on the th~ead 19. These coils can be kept together, so that they exhibit the form illustrated, and can also be made stiff by heating " ,) .
.... .
so that the material partly meits from the fibre-like structure of the thread 19to an amorphous structure. By the utilization of a thin thread, also very small anrhoring mcans can be made in this manner.
Because of the springing wings of the anchoring means, an anchoring of the device in its non-swollen condition is thus obtained. Because of the back-wards swept shape of~ the wings they can yield in a pringing manner during the insertion operation, but if one tries to take out the device, they tend to expand.
When the swellable body is in its swollen state the outer portions of the ancho-ring means will at least partly d7sappear inside the body, as is hinted in Fig. 1, wh_re a dashed and dotted line approximately illustrates the size of the body 2 after its swelling. When the swelling property is gre~t and the body tissues ~:an be forced out of their place, the channel can get so widened that the an--choring means completely looses the contact with the walls of the cavity even if the outer points of the means were in contact with the walls during the inser-tion operation. In this manner any imaginable irritation as a consequence of thepoints of the means will be eliminated tluring the condition of permanency.
The body 2 and 13 respectively is preferably made of a hydrophilic mo-nomer such as polyvinyl pyrrolidone and a hydrofobic compound such an acrylate or a polyamide, which by means of copolymerisation (graft polymerisation) has been fastenecl to the thread and the anchoring means respectively. The swelling and the force exercised because of the absorbtion of water from the body fluid can be varied by changing the proportions between the hydroph~lic and the hydrofobic monomers. Three (3) parts of the hydrophilic monomer (vinyl pyrro-lidone) and one (1) part of the hydrofobic monomer (polyamide) form a copoly-mer with an expanding factor of 1,48 counted lineary ~swells 48% in waterj with a water content o~ 66%; five (S) parts of the hydrophilic monomer and cne ~1) part of the hydrofobic monomer yield a copolymer with an expanding factor of 1,72 with a water content of 78%.
In spite of the device according to the invention having been described in the form of a contraceptive means, it should be understood that other appli-cations can be made, by eay of example in connection with brain damage, such as cerebral expansion of blood vessels, or for the treatment of varicose veins.
In these ~ases the contrivance is inserted in the intended blood vessel in orderto completely occlude the same. In such applications the hour-glass form of the device is preferred.
ceptive motives, the ovlducts or $permatic ducts then bei'ng occluded or causes' of a desease, wh~ch may require the blocking of a body channeI~
The swellable body in question has in the prior art been made'of fibrous substances', which swell when absorbing a body fluld, but it has no~ been' discovered that water-absorbing copolymer plastics, also called hydrogel compounds, are'appro-priate. The blocking is performed in such a manner that the swelling body in non-swollen condition is inserted into the body channel concerned. The form and dimensions of the body is adapted in such a way that it can easily be inserted into the channel. After its insertion it absorbs fluid from the surrounding tissued, which causes it to sweIl. The channel is thereby blocked, as was intended, and the body at the same time obtains a firm hold in the same. The material shall substantially be inert to the body fluid and to the surrounding tissues, so that the body will remain intact and can be removed when it has served its purpose. By means of such an arrangement one can by way of example restore the function of the oviducts or the spermatic ducts after blocking in preventive purpose.
~ owever, it has in practise turned out that there i<5 a risk that the body is carried out of the channel by a muscular movement or by being washed away during the first period after its insertion, when it has not yet had time to absorb so much body fluid that it has acquired such size that it has got a tight fit to the surrounding walls. In some connection such a dilatation of the channel can occur that the dimensions of the body no longer is sufficient resultin~ in a risk for expulsion.
It is an object of the present invention to eliminate said risk of expulsion out of the channel or displacement in the same.
- It is another object of the invention to provide a means, in which simple'measures are used to eliminate said risk in such a way that the body in its normal swel'lea-up condition without any special drawbacks works' ~n its normal function to occlude the'channeI~
X
~ 2'~S2~Z~3 In the' a;:companying drawings two embodiments of a body aocording to the invention and four embodiments of an element forming part of the device according to the invention are shown.
Fig. 1 in these drawings is a view of a longitudinal cross-section through the body accor~ing to the first embodiment; Fig. 2 shows the same body in a cross-sectional view; ~Fig. 3 shows the body according to the second embodiment in a longitudinal cross-section; Fig. 4 shows an element forming part of the body according to an embodiment, and Fig. 5 shows the element according to another embodiment.
The device accordirlg to the inventioi7 comprises, as mentioned, a body of a material, which, when brought into contact with a body ~luid, swells with respect to its volume at least by 20% measured as a linear expansion. ' Apart from the property to swell the body is substantially inert to thc body fluids and to the surrounding tlssues. The swelling of the body in contact with a bo-dy fluid is preferably at least 40% and for example at least 80%. The swelling' can vary between 20-300% in linear measure. The channel shaped cavities of human beings and animals, which can be blocked by means of th~ device accor-ding to the invention, ~re by way of e-xample blood vessels, urethra, spermatic ducts and oviducts.
The geometric shape of the body, whi~h is inserted into the conduit-shaped cavity, is not critical and the body can by way of exarnple essentially be cylindric, spherical, egg-shaped or of hour glass shape. It also suitably exhibits an essentially cylindric cross-sectian in the one cross-section corres-ponding to the cross-section of the channel or cavity. Said cross-section of the not y~t swelled body is so much smaller than the cross-section of the chan-nel that the body can be inserted into the channel with a play relative to lts walls, whereby the insertion can take plac~ with the least possible difficulty.
The means of the kind mentioned are especially suitable tor use as con-traceptive means, the body being inserted into the spermatic duct or the ovi-duct respectively. In the latter case a thread is preferably fastened to the bo-dy, so that it can be extracted without any operative incision. This thread can be made of a radiopaque material, sv that a control of the position of the body can be made. The body can alternatively in itself be made of X-ray contrasting material. The material of the body swells in contact with the body fluid by at least 40% suitably at least 80% and can even swell by so much as 300%. The rna-terial shall for the rest be essentially inert to the body fluid and shall not be harmful to or be absorbed by the body. Hydrogel compounds constitute a suit-able group of materials. Said mat~rials swell by absorbing water out o~ the bodyfluid. Suitable hydrogel compounds are polymers and copolymers of metacrylic -~a ' ~ .
, 3 ~ 2~3 acid esters with at least one hydroxy group in the lateral chain. A suitable mo-nomer is 2-hydroxy ethyl metacryiate, in which the ester group can be derived from diethylene glycol or triethylene glycol. 2,3-dihydroxy propyl metacrylate is by way of example also usefwl. As a cross linking compound such polyfunc-tional acrylates as diesters or corresponding glycols, ~r example ethylene gly-coi bis~metacrylate ca~l be used.
A copolymer of a hydrophilic monomer and a hydroFobic monomer consti-tute another example of materials suitable for the body according to the inven-tion. By means of varying the proportions between the hydrophilic and the hydrofobic monomer the property of water absorbtion and consequently the swel-ling of these materials be varied within wide limits. Monomers of the group com-prising N-vinyl pyrrolidones and vinyl pyridines can be mentioned as examples of the hydrophilic component, and monomers of the group comprising methyl acrylates and methyl metacrylates cen be mentioned as examples of the hydro-fobic component. A polymerisation suitably takes place by subjecting the star-ting materials to electromagnetic radiation in the ultravioiet-~amma radiation region or by heating.
The body shall essential!y be resilient and only to a very small extent be plastic. In non-swollen (not hydrated~ condition it can be stiff and/or hard,' but in the course of the swelling process it should soften. The body can con-tain substances, which makes it more radiopaque, by way of example salts of barium or bismuth or metal powder (silver3.
When the body is to be used, the same is inserted into the channel shaped cavity in non-swollen condition and thlereafter the body swells in con-tact with the body fluid, so that the body, which during its insertion can pass through' the channel swells and is brought into good contact with the walls thereof. By the pressure then exercised on the body by the walls, the resili-ent body is compressed at the same time as the elastic walls of the cavity pos-sibly are expanded. The body thereby fills out the whole cross-section of the cavity and impedes any passage through the ame at the same time as the body is well held in position inside the cavity. After inserting the body in for example an oviduct the passage of an egg down into the uterus and sperm cells up through the oviduct to the unfertilized egg respectively is impedecl. When occlu-ding a spermatic duct the passage of the sperm celi through the same is impe-ded, and a good preventive protection is obtained. The inserted bodies can according to wish again be removed by means of an operation, or, as is the case in connection with the insertion in the oYiducts, it can be drawn out to the uterus in those cases the body is provided with an adherent thread, by means of which the body can be pulled out.
:~, . . . . ..
4 ~ ~ S;~il21~
Thus, the body in its inserted position obtains a good anchoring in the body çhannel or in the cavity, in which it is inserted, after the body has ab-5nrbed body fluid and has swo!len. However, this requires some time, and be-fore so has taken place, the body exhibits a play relative to the surrounding tissue walls. The body in its non-swollen condition is, as mentioned, so much s,..aller than the ca~ity or -the channel that it easily can be inserted into the ~ody cavity in question. When the body has to be moved ~or a longer distance into the Ibody channel and also possibly may pass a section, which is narrower than the one, where the body is intended to be placed, it is necessary that body exhibits a considerable amount of undersize. The idea behind the de-.ce is also the one that the body, when the insertion takes place, shall exhi-it this smaller dimension but acquire the large dimension, which is necessary for a secure application and an efficient occlusion o~ the channel after the bo-dy's accomodation in the intended place.
However, if these conclitions'are fulfilled the body does not obtain any, secure anchcring until the swelling process has taken place, and therefore a period of insecurity arises immediately upon the insertion, when the body'under unfavourable circumstances can get displaced by body fluid flowing through the conduit or - by movements of the person accomodating the inser~ed body. This insecurity of function is, however, eliminated by means of the present inven-tion. ~he elimination takes place by providing the body with at least one se-curing means of a material of adjusted stiffness. This means exhibits outer parts, which at least in the non-swollen condition of the body project outside of the same, and'so far out 'that they arrive in; contact with the wails of the surrounding cavity, when the insertion of the body ~ has taken place in the de-sired manner. Thus, said projecting parts thereby serve as locking means, which wi th a spring ~orce hold the body in its inserted place. Said springing means are'suitably designed to exhibit such a lockin~ function that their !ocking action wil! be of low or no effect during the movement in the direction of inser-tion, but during an attempt to move the body out of the channel are effective by an expanding action.
Thus, the projecting parts of the means serve as anchoring means only or essentially before the body has acquired its swoiien condition. They can therefore exhibit such dimensions that the greater part of them will be inside the surface of the body, when they have acquired their swolien condition there-by being held in place. By this arrangement one avoids that the projecting parts in a too high degree are pressed in into the surrounding body tissue during the condition of permanency, when the body has acquired its swollen condition .
, .
~Lt;~2~
A device 1 according to the invention and intended for insertion in the ovidur-t ~f a woman is shown in a longitudinal cross-section in Fig. 1. It is forrnPd hy a long, cylindric (compare Fig. 2) body 2 of the swelling material mentiDned and exhibiting an inner, rounded-off end portion 3 and an outer ball-shaped end portion 4. A thread 5 is secured to the body 2 and preferably con-sists ^f nylon, said~thread terminating inside the inner end 3 but extending outside of the body at the end 4 exhibiting a free portion 6.
As an example of suitable dimensions o~ the body 2 in the application described a length of 11 mm with the exception of the free portion 6 of the thresd and a maximum diameter of 1,66 mm can be mentioned. The body can al-ternatively have the shape of a drop with a diameter of approximately 0,8 mm of .he small end of the non-swollen condition.
The thread 5 is preferably made of polyamide fibre and at least in part made impermeable byx-rays.
One or several means 7 for the anchoring of the body mentioned extend through the same and in the non-swoilen condition of the body 2 exhibit projec-ting portions 8. The mid portion 9I from which the outer parts 8 are projecting is located inside the material of the body 2 also in its non-swollen condition and thus, forms an anchoring of the means 7. Moreover the thread 5 extends through a hole 10 of the means 7, whereby an extraordinary anchoring of the means 7 and the thread 5 to the materlal of the body 2 is reciprocally obtained. The con-nection of the thread 5 and the means 7 is moreover advantageous, when the device 1 is manufactured, as only one element needs to be placed in the forming tool, and durinç~ the forming operation itself the parts in question can be heldby holding the projecting portions 8 vf the means 7, which portions project out-side of the very ~orming ohamber for the body 2. A good connection between the means 7 and the thread can be obtained, if the hole 1û as is hintecl ln Fig.2 is provided with portions 11, directed inwards and penetrating into the thread 5.
An alternative holdlng arrangement is shown in Fig. 4, where the thread 5 has been provided with knots 12 on both sides of the means 7.
In the embodiment of the means 7 illustrated in Figs. 1, 2 and 4 its two haives on the sides of the hole 10 form triangular wings forming an acute ang-le to each other. Said wings as is hinted in Fig. 4 are at least slightly concave on the one of their sides facing the other wing. The form and the thickness can however, be adapted to the material chosen and to the required spring force di-rected outwards. The intention is that the measure over the ends of the means 7 shall be somewhat larger than the inner measure for the intended body channel so that the means 7 is expanciing against its walls but ir~ a yielding manner sothat the outer portions 8 can fold inwards, if during the insertion a narrow , 6 ~ L~28z8 section is passed. By the yielding property an adaptation to different cross~
sections of the channels are in addition obtained.
The rnaterial of the means 7 must not have any harmful effect to the body of the person, in which the device is inserted. A somewhat semi-stiff springing plastic material such as acetal plastics or an amide is preferably used.
A device 13 is illustrated in 3 longitudinal cross-section in Fig. 3 and correspQnds to a second example of embodiment. This device is intended for insertion in the spermatic duct and its dimensions and its form is adapted t~ this purpose. It has a long cylindric shape of the length of for exampie 6 mm and a di..meter of approximately 0,6 mm, which, thus is valid for the non-swollen con-dition of the body made of swellable material and here indicated with 14.
The insertion in the spermatic duct cannot take place from outside, bu~
has to be performed by an operative incision, during which the spermatic duct is opened up, whereafter the device 13 can be inserted, the spermatic duct suhcequently being occluded. The non-swollen condition of the body 14 means that the body has smaller dimensions than the inner space of the spermatic duct becal~se of which the insertion is facilitated. After the insertion the body 14 swells by absorbing body fluid in accordance with what has been described in the ~oregoing. A removal of the device, if so desired, can take place also by means of an operative incision. It is therefore useless to provide the device with a thread, and besides to be able to control its p~sition i~y means of X-rays, the material of the body 14 shall be made of at least in part radiopaque material by way of example by metals or metal salts forming part of the same. Also the device 13 contains a means 15 for the anchorin~3 during its non-swoilen condi-tion. As was the case with the means 7 this one exhibits outer portions 16 swungout towards one end of the body 14, said portions 16 exhibiting a yielding pro-perty and a propensi$y to expand against the wall of the spermatic duct. The outer portions and the mid-portions 17, the latter by casting operation enclosedinside the body 14 are made in an open piece exhibiting a rod-shaped centre portion 18, which is used for the anchoring to the body 14. The means 15 will of course exhibit very small dimensions as the body 14, as mentioned, has a dia-meter of less than 1 mm.
An alternative form of the anchoring means is illustrated in Fig. 5. A
thread 19 of polyamide fibre is here utilized. This thread can be used in the same manner as the extractable thread 5 and thus, prsject outside of the swell-able body. However, it can also be so short that it only constitutes holdin~
means like ~e part 18. The projecting wings, which shall form the outer por-tions, are formed by coils on the th~ead 19. These coils can be kept together, so that they exhibit the form illustrated, and can also be made stiff by heating " ,) .
.... .
so that the material partly meits from the fibre-like structure of the thread 19to an amorphous structure. By the utilization of a thin thread, also very small anrhoring mcans can be made in this manner.
Because of the springing wings of the anchoring means, an anchoring of the device in its non-swollen condition is thus obtained. Because of the back-wards swept shape of~ the wings they can yield in a pringing manner during the insertion operation, but if one tries to take out the device, they tend to expand.
When the swellable body is in its swollen state the outer portions of the ancho-ring means will at least partly d7sappear inside the body, as is hinted in Fig. 1, wh_re a dashed and dotted line approximately illustrates the size of the body 2 after its swelling. When the swelling property is gre~t and the body tissues ~:an be forced out of their place, the channel can get so widened that the an--choring means completely looses the contact with the walls of the cavity even if the outer points of the means were in contact with the walls during the inser-tion operation. In this manner any imaginable irritation as a consequence of thepoints of the means will be eliminated tluring the condition of permanency.
The body 2 and 13 respectively is preferably made of a hydrophilic mo-nomer such as polyvinyl pyrrolidone and a hydrofobic compound such an acrylate or a polyamide, which by means of copolymerisation (graft polymerisation) has been fastenecl to the thread and the anchoring means respectively. The swelling and the force exercised because of the absorbtion of water from the body fluid can be varied by changing the proportions between the hydroph~lic and the hydrofobic monomers. Three (3) parts of the hydrophilic monomer (vinyl pyrro-lidone) and one (1) part of the hydrofobic monomer (polyamide) form a copoly-mer with an expanding factor of 1,48 counted lineary ~swells 48% in waterj with a water content o~ 66%; five (S) parts of the hydrophilic monomer and cne ~1) part of the hydrofobic monomer yield a copolymer with an expanding factor of 1,72 with a water content of 78%.
In spite of the device according to the invention having been described in the form of a contraceptive means, it should be understood that other appli-cations can be made, by eay of example in connection with brain damage, such as cerebral expansion of blood vessels, or for the treatment of varicose veins.
In these ~ases the contrivance is inserted in the intended blood vessel in orderto completely occlude the same. In such applications the hour-glass form of the device is preferred.
Claims (9)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. Device for temporary or permanent occlusion of body channels or cavities in human or animal bodies and comprising a body of a material, which swells at least 20%
by absorbing of body fluid and which is substantially inert to the body fluid and the surrounding tissues, the body is dimensioned to be inserted into the channel or cavity with a play according to the surrounding walls in unswollen state of the body but to occlude the entire cross-section of the channel or cavity in swollen state thereby being anchored by means of pressure against the surrounding walls of the channel or cavity, characterized by anchoring means attaching to the body which means comprises portions which at least in the unswollen state of the body in a determined way projects from the surface of the body which means are made of a material with such yielding properties that the means with said portions in a yielding way are pressed outwards against the surrounding walls to the channel or the cavity so that the means adapts itself to the cross-section of the channel or cavity and locks the body in its inserted position by means of the pressure against said wall resulting in an anchoring of the body also during first period before it exerts any direct pressure against the surrounding wall as a result of its swelling.
by absorbing of body fluid and which is substantially inert to the body fluid and the surrounding tissues, the body is dimensioned to be inserted into the channel or cavity with a play according to the surrounding walls in unswollen state of the body but to occlude the entire cross-section of the channel or cavity in swollen state thereby being anchored by means of pressure against the surrounding walls of the channel or cavity, characterized by anchoring means attaching to the body which means comprises portions which at least in the unswollen state of the body in a determined way projects from the surface of the body which means are made of a material with such yielding properties that the means with said portions in a yielding way are pressed outwards against the surrounding walls to the channel or the cavity so that the means adapts itself to the cross-section of the channel or cavity and locks the body in its inserted position by means of the pressure against said wall resulting in an anchoring of the body also during first period before it exerts any direct pressure against the surrounding wall as a result of its swelling.
2. Device according to claim 1, characterized by said portions of said means being directed in an oblique angle backwards in relation to the intended direction of introduction in the body channel so that said portions by the introduction can pivot towards each other but tend to move away from each other thereby locking the body by movements reverse to the direction of introduction.
3. Device according to claim 1, characterized by the distance from the surface of the body to free outer end of the respective portions of said anchoring means in the unswollen condition of the body being substantially the same as the distance which said surface of the body moves outwards by the swelling of the body so that said portions are substantially enclosed in the body in the swollen state of the same.
4. Device according to any of the preceding claims, wherein said anchoring means comprises a mid-portion which is enclosed in the body and carries projections the free ends of which form said portions.
5. Device according to claim 1, 2 or 3, wherein said anchoring means comprises a mid-portion which is enclosed in the body and carries projections the free ends of which form said portions, the mid-portions of the anchoring means being formed of a first portion of a thread enclosed in the body with a second portion of which thread is stretching outside the body.
6. Device according to claim 1, 2 or 3, wherein said anchoring means comprises a mid-portion which is enclosed in the body and carries projections the free ends of which form said portions, mid-portions of the anchoring means being formed of a first portion of a thread enclosed in the body with a second portion of the thread stretching outside the body, the body being an elongated cylinder with a diameter of substantially 1-2 mm and enclosing said first portion of the thread with said anchoring means formed of a rigid material such as plastic and comprising at least two projections, the outer ends of which form said portions of the anchoring means, whereby the device is suitable for the occlusion of the oviduct of a woman or an animal.
7. Device according to claims 1, 2 or 3, characterized by the body consisting of a hydrogel.
8. Device according to claims 1, 2 or 3, characterized by the body consisting of hydrogel formed by a copolymer of at least one hydrophilic monomer and at least one hydrofobic monomer.
9. Device according to claims 1, 2 or 3, characterized by the body consisting of a hydrogel which is adapted to swell at least 40% and preferably at least 80% in contact with the body fluid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000351368A CA1152828A (en) | 1980-05-06 | 1980-05-06 | Device for occlusion of bodychannels |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000351368A CA1152828A (en) | 1980-05-06 | 1980-05-06 | Device for occlusion of bodychannels |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1152828A true CA1152828A (en) | 1983-08-30 |
Family
ID=4116872
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000351368A Expired CA1152828A (en) | 1980-05-06 | 1980-05-06 | Device for occlusion of bodychannels |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1152828A (en) |
-
1980
- 1980-05-06 CA CA000351368A patent/CA1152828A/en not_active Expired
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| Date | Code | Title | Description |
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| MKEX | Expiry |