CA1121553A - Self-sealing valve for breast prosthesis - Google Patents
Self-sealing valve for breast prosthesisInfo
- Publication number
- CA1121553A CA1121553A CA000328420A CA328420A CA1121553A CA 1121553 A CA1121553 A CA 1121553A CA 000328420 A CA000328420 A CA 000328420A CA 328420 A CA328420 A CA 328420A CA 1121553 A CA1121553 A CA 1121553A
- Authority
- CA
- Canada
- Prior art keywords
- valve
- valve body
- prosthesis
- liquid
- self
- 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.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/12—Mammary prostheses and implants
Abstract
ABSTRACT OF THE DISCLOSURE
In an inplantable breast prosthesis of the type intended to be inflated with liquid there is a self-sealing valve for adjusting the liquid volume in the prosthesis. The valve is thimble-shaped, the open end being guarded by a self-sealing gel plug which receives the needle of a hypodermic while the closed end acts as a stop preventing further insertion of the needle which might otherwise puncture the prosthesis. The contents of the hypodermic reach the prosthesis interior through apertures in the valve which lie normal to the direction of needle entry.
A method of post- implantation treatment consists of adjusting the dose of steroid in the interior of the prosthesis.
In an inplantable breast prosthesis of the type intended to be inflated with liquid there is a self-sealing valve for adjusting the liquid volume in the prosthesis. The valve is thimble-shaped, the open end being guarded by a self-sealing gel plug which receives the needle of a hypodermic while the closed end acts as a stop preventing further insertion of the needle which might otherwise puncture the prosthesis. The contents of the hypodermic reach the prosthesis interior through apertures in the valve which lie normal to the direction of needle entry.
A method of post- implantation treatment consists of adjusting the dose of steroid in the interior of the prosthesis.
Description
This invention concerns a mammary prostheses and particularly the valve through which liquid filled prostheses are aspirated and filled.
While augmentation mammaplasty is a w~delyavailable technique, one recognised difficulty which arises from the implantation of a mammary prosthesis is the inclination of the tissues in contact with the prosthesis to form scar tissue at the contact boundary. This can produce a scar capsule around the prosthesis and the consequent contraction of the scar, if untreated, may eventually produce a hard distorted breast. Scar tissue formation can be suppressed and even catabolised by treatment with a solution of the appropriate steroid. The drawback of this treatment is that a dose of steroid which is large enough to disperse the scar tissue is also large enough to produce atrophy o~ the breast tissue beyond the scar. Clearly an e~uilibrium dose exists for each patient which is optimal for both scar dispersal and minimizing breast tissue atrophy but there is no means of safely altering the dose of drug in the interior of the prosthesis without recourse to reversal of the surgery. The reasons for:this lie in the design of the presently available prostheses.
One form of prosthesis is a bag of elastomeric material containing a self-sealing gel plug through which the bag interior is filled with about 200ml. of sterile saline solution.
Another form of prosthesis is a double lumen version, each lumen being defined by an elastomeric wall wherein the inner .~
While augmentation mammaplasty is a w~delyavailable technique, one recognised difficulty which arises from the implantation of a mammary prosthesis is the inclination of the tissues in contact with the prosthesis to form scar tissue at the contact boundary. This can produce a scar capsule around the prosthesis and the consequent contraction of the scar, if untreated, may eventually produce a hard distorted breast. Scar tissue formation can be suppressed and even catabolised by treatment with a solution of the appropriate steroid. The drawback of this treatment is that a dose of steroid which is large enough to disperse the scar tissue is also large enough to produce atrophy o~ the breast tissue beyond the scar. Clearly an e~uilibrium dose exists for each patient which is optimal for both scar dispersal and minimizing breast tissue atrophy but there is no means of safely altering the dose of drug in the interior of the prosthesis without recourse to reversal of the surgery. The reasons for:this lie in the design of the presently available prostheses.
One form of prosthesis is a bag of elastomeric material containing a self-sealing gel plug through which the bag interior is filled with about 200ml. of sterile saline solution.
Another form of prosthesis is a double lumen version, each lumen being defined by an elastomeric wall wherein the inner .~
-2- ~
11;~1~5S3 lumen is occupied by a silicone gel amounting to 180 ml.
volume and ~he surrounding outer lumen amounts to only a further 20 ml. Consequently the outer lumen is thin and it too may be inflated to its designed volume by injection of saline between the contacting flaps of a flap valve.
Any subsequent attempt to introduce a needle through the breast tissue in an effort to locate the plug may puncture the prosthesis. Thus, it can be seen that there is no reliable way of changing the conc.entration of the drug Gnce introduced. The patient must therefore put up with the tissue atrophy due to the ~nintentional overdose or undergo reversal of surgery.
According to on.e aspect of this invention there is provided a method of preventing or dispersing scar tissue associated with an implanted, liquid-containing mammary prosthesis comprising adding a solution o a scar tissue-preventing or dispersing drug into the liquid located in the interior of the prosthesis, allowing the solution to diffuse through the wall of the prosthesis for the optimal time and subsequently adjusting the drug concentration by replacing the liquid in the prosthesis by either further drug in solution or liquid which does not contain the drug. The drug is preferably injected into or aspirated from a chamber defined by the body of the self sealing valve beyond which penetration of the needle is prevented by contact with the valve body, which chamber is in co~munication with the liquid located in the interior of 155~
the container. It is most useful if the initial injection of the drug accompanies the inflation of the prosthesis.
According to an apparatus aspect of the invention there is provided a valve for a ma~mary prosthesis implant of the ba3-containing-liquid type, said valve comprisinu a valve body having a valve chamber, said body having an open end protected by a self-sealing gel plug and a blind end situated opposite the open end for limiting the ingress of a needle or catheter inserted into said chamber through said plug, said valve body having one or more liquid transfer apertures therein in a region other than said blind end.
The longitudinal axis of the or each liquid transfer aperture is preferably substantially at right angles to the needle or catheter entry axis~ The valve body may be hemispherical and there may be two or more liquid transfer apertures in the equatorial region. Alternatively, the valve body may be substantially conical and the liquid transfer aperture or apertures is or are in the curved wall of the valve body. Preferably the mouth of the open end of the valve is covered with mesh secured to the valve body perimeter and the self-sealing plug is a stiff silicone gel located within the valve body and supported by said mesh. The valve body may contain one or more radio-opaque inclusions.
According to a further apparatus aspect there is `` 1~;~1553 provided an i.mplanta~le mammary prosthesis comprising a flexible container made of a silicone elastomer, a self-sealing valve sealed to said container through which liquid is introducible into the interior of said container for the purpose of inflating the same characterised in that the valve comprises a valve body defining a valve chamber, said body having an open end protected by a self-sealing gel plug and a blind end situated opposite the open end for limiting the ingress of a needle or catheter inserted into said chamber through said plug, said valve body having one or more liquid transfer apertures therein in a region other than said blind end, said aperture or apertures being in communication with the container interior whereby liquid injected into said chamber reaches the interior of said container.
Preferably the valve body is surrounded by a layer of li~uid permeable synthetic plastic foam or web for preventing the~ elastomer of the container from contacting the aperture or apertures during aspiration of solution of scar tissue preventing or dispersing the drug during adjustment of concentration procedure.
One embodiment of the invention is now described with reference to the accompanying drawings in which:
Figure 1 is a perspective view of an i.nflated prosthesis in an implanted attitude showing the valve occupying the position in the inferior segment of the breast;
Figure 2 is a section through the part of the prosthesis SS~
which contains the valve.
Referring now to the drawings, figure 1 shows the hemispherical prosthesis 2 bounded by an elastomeric wall 4 to which is sealed the valve 6. In figure 2 the valve has a body 8 of uniform thickness made of a translucent polymethacrylate. The body is substantially thimble-shaped and has a mouth end 10 and a blind domed end 12. The valve is about 15mm in diameter and is hard enough to be located by palpation. The mouth end is protected by a layer of nylon mesh 14. A silicone gel plug 16 closes the mouth end and is stuck to the mesh with an adhesive layer 18 which also contacts the valve body 8 and penetrates holes 20 therein provided for improving adhesion. The elastome-ric wall 4 is pierced and sealed to the exterior of the valve body 8 by a layer of adhesive 22. Four apertures 24 are provided midway along the body 8. The axial direction of all four apertures is at right angles to the direction of insertion of the catheter or needle ~not shown) which would enter the chamber 26 more or less normal to the surface of the mesh. The valve body region around said apertures 24 is protected by a disc 28 of coarse plastic webbing.
The valve body has striped inclusions of radio-opaque material ~not shown) in order to assist exact location by fluoroscopy but it is expected that in most patients the valve will be readily located by palpation. The valve body may be made of metal for example titanium but a the-rmoplastic mat~rial is preferred. The body of the valve need not be so thick as to preclude piercing by a needle. Some needles are very sharp and would puncture even a thick plastic valve. The valve should be thick enoush to indicate to the surgeon, by certain increased resistance to the further pressure applied to the needle, that the dome has been contacted whereupon the liquid content of the mammary prosthesis may be removed and/or supplemented with further liquid, be discharged. In practice a valve of the thickness of 0.5 to 1.5 mm has proved useful.
The manner of use is as follows. The prosthesis is filled with a solution of saline and an anti-inflammatory steroid such as SOLUMF,n.~o~" (Re~istered Trade Mark). The surgery is performed and the prosthesis is implanted. Four weeks after ~urgery the valve is located by palpation and a hypodermic needle is inserted into the valve until the end of the needle contacts the dome. The saline and steroid solution is aspirated from the valve chamber and thence via the liquid transfer apertures from the,interior of the prosthesis until the prosthesis is empty. A slmilar ~olume of saline without steroid is then injected into the prosthesis by a reverse procedure. Now the needle is withdrawn and a close check of the clinical course of the patient is made. In the event of development of breast firmn.ess due to scar capsule contraction (perhaps - 25 years later) a new dose of steroid may be introduced into the prosthesis by injection of a small volume of concentrated steroid solution into the va~lve chamber. The steroid passes via the fluid transfer parts into and is diluted by the saline solution in the prosthesis. Clearly this latter procedure may be repeated.
I have found the advantages of the valve to be that its identifiable shape simplifies recognition by palpation and ensures that the physician can easily check that the piercable plug is the part of the valve which lies closest to the skin surface; it is easily distinguishable from a static lump which might develop in the breast as a result of the carcinoma; it affords a reliable route to the interior of the prosthesis without risk of damage to the latter; it is applicable to both single and double lumen prosthesis. I have found the advantages of the method to be that it permits the alteration of the concentration of the drug within the prosthesis to be closely controlled with a minimum of discomfort to the patient; it results in a more suitable breast shape which is a consequence of mlnlmlslng scar tissue contraction; it permits the size of the breasts to be equalised after surgery is safely completed.
11;~1~5S3 lumen is occupied by a silicone gel amounting to 180 ml.
volume and ~he surrounding outer lumen amounts to only a further 20 ml. Consequently the outer lumen is thin and it too may be inflated to its designed volume by injection of saline between the contacting flaps of a flap valve.
Any subsequent attempt to introduce a needle through the breast tissue in an effort to locate the plug may puncture the prosthesis. Thus, it can be seen that there is no reliable way of changing the conc.entration of the drug Gnce introduced. The patient must therefore put up with the tissue atrophy due to the ~nintentional overdose or undergo reversal of surgery.
According to on.e aspect of this invention there is provided a method of preventing or dispersing scar tissue associated with an implanted, liquid-containing mammary prosthesis comprising adding a solution o a scar tissue-preventing or dispersing drug into the liquid located in the interior of the prosthesis, allowing the solution to diffuse through the wall of the prosthesis for the optimal time and subsequently adjusting the drug concentration by replacing the liquid in the prosthesis by either further drug in solution or liquid which does not contain the drug. The drug is preferably injected into or aspirated from a chamber defined by the body of the self sealing valve beyond which penetration of the needle is prevented by contact with the valve body, which chamber is in co~munication with the liquid located in the interior of 155~
the container. It is most useful if the initial injection of the drug accompanies the inflation of the prosthesis.
According to an apparatus aspect of the invention there is provided a valve for a ma~mary prosthesis implant of the ba3-containing-liquid type, said valve comprisinu a valve body having a valve chamber, said body having an open end protected by a self-sealing gel plug and a blind end situated opposite the open end for limiting the ingress of a needle or catheter inserted into said chamber through said plug, said valve body having one or more liquid transfer apertures therein in a region other than said blind end.
The longitudinal axis of the or each liquid transfer aperture is preferably substantially at right angles to the needle or catheter entry axis~ The valve body may be hemispherical and there may be two or more liquid transfer apertures in the equatorial region. Alternatively, the valve body may be substantially conical and the liquid transfer aperture or apertures is or are in the curved wall of the valve body. Preferably the mouth of the open end of the valve is covered with mesh secured to the valve body perimeter and the self-sealing plug is a stiff silicone gel located within the valve body and supported by said mesh. The valve body may contain one or more radio-opaque inclusions.
According to a further apparatus aspect there is `` 1~;~1553 provided an i.mplanta~le mammary prosthesis comprising a flexible container made of a silicone elastomer, a self-sealing valve sealed to said container through which liquid is introducible into the interior of said container for the purpose of inflating the same characterised in that the valve comprises a valve body defining a valve chamber, said body having an open end protected by a self-sealing gel plug and a blind end situated opposite the open end for limiting the ingress of a needle or catheter inserted into said chamber through said plug, said valve body having one or more liquid transfer apertures therein in a region other than said blind end, said aperture or apertures being in communication with the container interior whereby liquid injected into said chamber reaches the interior of said container.
Preferably the valve body is surrounded by a layer of li~uid permeable synthetic plastic foam or web for preventing the~ elastomer of the container from contacting the aperture or apertures during aspiration of solution of scar tissue preventing or dispersing the drug during adjustment of concentration procedure.
One embodiment of the invention is now described with reference to the accompanying drawings in which:
Figure 1 is a perspective view of an i.nflated prosthesis in an implanted attitude showing the valve occupying the position in the inferior segment of the breast;
Figure 2 is a section through the part of the prosthesis SS~
which contains the valve.
Referring now to the drawings, figure 1 shows the hemispherical prosthesis 2 bounded by an elastomeric wall 4 to which is sealed the valve 6. In figure 2 the valve has a body 8 of uniform thickness made of a translucent polymethacrylate. The body is substantially thimble-shaped and has a mouth end 10 and a blind domed end 12. The valve is about 15mm in diameter and is hard enough to be located by palpation. The mouth end is protected by a layer of nylon mesh 14. A silicone gel plug 16 closes the mouth end and is stuck to the mesh with an adhesive layer 18 which also contacts the valve body 8 and penetrates holes 20 therein provided for improving adhesion. The elastome-ric wall 4 is pierced and sealed to the exterior of the valve body 8 by a layer of adhesive 22. Four apertures 24 are provided midway along the body 8. The axial direction of all four apertures is at right angles to the direction of insertion of the catheter or needle ~not shown) which would enter the chamber 26 more or less normal to the surface of the mesh. The valve body region around said apertures 24 is protected by a disc 28 of coarse plastic webbing.
The valve body has striped inclusions of radio-opaque material ~not shown) in order to assist exact location by fluoroscopy but it is expected that in most patients the valve will be readily located by palpation. The valve body may be made of metal for example titanium but a the-rmoplastic mat~rial is preferred. The body of the valve need not be so thick as to preclude piercing by a needle. Some needles are very sharp and would puncture even a thick plastic valve. The valve should be thick enoush to indicate to the surgeon, by certain increased resistance to the further pressure applied to the needle, that the dome has been contacted whereupon the liquid content of the mammary prosthesis may be removed and/or supplemented with further liquid, be discharged. In practice a valve of the thickness of 0.5 to 1.5 mm has proved useful.
The manner of use is as follows. The prosthesis is filled with a solution of saline and an anti-inflammatory steroid such as SOLUMF,n.~o~" (Re~istered Trade Mark). The surgery is performed and the prosthesis is implanted. Four weeks after ~urgery the valve is located by palpation and a hypodermic needle is inserted into the valve until the end of the needle contacts the dome. The saline and steroid solution is aspirated from the valve chamber and thence via the liquid transfer apertures from the,interior of the prosthesis until the prosthesis is empty. A slmilar ~olume of saline without steroid is then injected into the prosthesis by a reverse procedure. Now the needle is withdrawn and a close check of the clinical course of the patient is made. In the event of development of breast firmn.ess due to scar capsule contraction (perhaps - 25 years later) a new dose of steroid may be introduced into the prosthesis by injection of a small volume of concentrated steroid solution into the va~lve chamber. The steroid passes via the fluid transfer parts into and is diluted by the saline solution in the prosthesis. Clearly this latter procedure may be repeated.
I have found the advantages of the valve to be that its identifiable shape simplifies recognition by palpation and ensures that the physician can easily check that the piercable plug is the part of the valve which lies closest to the skin surface; it is easily distinguishable from a static lump which might develop in the breast as a result of the carcinoma; it affords a reliable route to the interior of the prosthesis without risk of damage to the latter; it is applicable to both single and double lumen prosthesis. I have found the advantages of the method to be that it permits the alteration of the concentration of the drug within the prosthesis to be closely controlled with a minimum of discomfort to the patient; it results in a more suitable breast shape which is a consequence of mlnlmlslng scar tissue contraction; it permits the size of the breasts to be equalised after surgery is safely completed.
Claims (9)
1. A valve for a mammary prosthesis implant of the bag-containing-liquid type, said valve comprising a valve body defining a valve chamber said body having an open end protected by a self-sealing plug and a blind end situated opposite the open end for limiting the ingress of a needle or catheter inserted into said chamber through said plug, said valve body having one or more liquid transfer aper-tures therein in a region other than said blind end.
2. A valve as claimed in claim 1, wherein the longitudinal axis of the or each liquid transfer aperture is substantially at right angles to the needle or catheter entry axis.
3. A valve as claimed in claim 1, wherein the valve body is hemispherical and there are two or more liquid transfer apertures in the equatorial region.
4. A valve as claimed in claim 1, 2 or 3, wherein the valve body is substantially conical and the liquid transfer aperture is the curved wall of the valve body.
5. A valve as claimed in claim 1, 2 or 3, wherein the mouth at the open end of the valve is covered with mesh secured to the valve body perimeter and the self-sealing plug is a stiff silicone gel located within the valve body supported by said mesh.
6. A valve as claimed in claim 1, 2 or 3, wherein the valve body contains one or more radio-opaque inclusions.
7. An implantable mammary prosthesis comprising a flexible container made of a silicone elastomer, a self-sealing valve sealed to said container through which liquid is introducible into the interior of said container for the purpose of inflating the same, characterized in that, the valve comprises a valve body defining a valve chamber, said body having an open end protected by a self-sealing gel plug and a blind end situated opposite the open end for limiting the ingress of a needle or catheter inserted into said chamber through said plug, said valve body having one or more liquid transfer apertures therein in a region other than said blind end, said aperture or apertures being in communication with the container interior to provide access for liquid injected into said chamber to reach the interior thereof.
8. A mammary prosthesis as claimed in claim 7, wherein the valve body is surrounded by a layer of liquid permeable plastic material for preventing the elastomer of the container from contacting the aperture or apertures during aspiration.
9. A mammary prosthesis as claimed in claim 7 or 8, wherein the valve body is hemispherical and there are two or more liquid transfer apertures in the equatorial region.
A mammary prosthesis as claimed in claim 7 or 8, wherein the valve body is substantially conical and the liquid transfer aperture is the curved wall of the valve body.
A mammary prosthesis as claimed in claim 7 or 8, wherein the valve body is substantially conical and the liquid transfer aperture is the curved wall of the valve body.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AUPD4522 | 1978-05-26 | ||
| AU452278 | 1978-05-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1121553A true CA1121553A (en) | 1982-04-13 |
Family
ID=3694964
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000328420A Expired CA1121553A (en) | 1978-05-26 | 1979-05-25 | Self-sealing valve for breast prosthesis |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1121553A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9351824B2 (en) | 2012-11-14 | 2016-05-31 | ImplantADJUST, LLC | Adjustable implant with self-sealing elastomeric membrane and methods of fabrication thereof |
| US10820984B2 (en) | 2012-11-14 | 2020-11-03 | ImplantADJUST, LLC | Implant with elastomeric membrane and methods of fabrication thereof |
-
1979
- 1979-05-25 CA CA000328420A patent/CA1121553A/en not_active Expired
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9351824B2 (en) | 2012-11-14 | 2016-05-31 | ImplantADJUST, LLC | Adjustable implant with self-sealing elastomeric membrane and methods of fabrication thereof |
| US10070951B2 (en) | 2012-11-14 | 2018-09-11 | ImplantADJUST, LLC | Adjustable implant with self-sealing elastomeric membrane and methods of fabrication thereof |
| US10820984B2 (en) | 2012-11-14 | 2020-11-03 | ImplantADJUST, LLC | Implant with elastomeric membrane and methods of fabrication thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US4433440A (en) | Prosthesis formed by inner and outer inflatable containers | |
| US4636213A (en) | Implantable prosthesis | |
| US5964806A (en) | Adjustable implantable genitourinary device | |
| EP0823851B1 (en) | Implantable catheter | |
| US4969899A (en) | Inflatable implant | |
| US3919724A (en) | Implantable prosthesis having a self-sealing valve | |
| US5611767A (en) | Radiation treatment of tumors using inflatable devices | |
| US4846784A (en) | Manually adjustable sphincteric system | |
| US4543088A (en) | Self-sealing subcutaneous injection site | |
| US6296657B1 (en) | Vascular sealing device and method | |
| US7828716B2 (en) | Implantable device and method for adjustably restricting a body lumen | |
| US20120029269A1 (en) | Apparatus and method for inserting an adjustable implantable genitourinary device | |
| EP1079765B1 (en) | Radiation protective device | |
| US6645138B2 (en) | Adjustable implantable genitourinary device | |
| US6572532B1 (en) | Implant positioning system and method | |
| CA1121553A (en) | Self-sealing valve for breast prosthesis | |
| CZ263794A3 (en) | Implantable port | |
| GB2180159A (en) | Mammary implant | |
| JPH0337078A (en) | Catheter connector and catheter assembly |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |