|Publication number||USRE35391 E|
|Application number||US 07/961,465|
|Publication date||Dec 3, 1996|
|Filing date||Oct 15, 1992|
|Priority date||Aug 30, 1984|
|Also published as||DE3573717C5, DE3573717D1, EP0174141A1, EP0174141B1, US4648880|
|Publication number||07961465, 961465, US RE35391 E, US RE35391E, US-E-RE35391, USRE35391 E, USRE35391E|
|Original Assignee||Brauman; Daniel|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (4), Non-Patent Citations (10), Referenced by (74), Classifications (13), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of U.S. patent application Ser. No. 12,583, filed Feb. 9, 1987, .Iadd.abandoned, .Iaddend.which was a divisional of earlier filed U.S. patent application Ser. No. 630,124, filed Aug. 30, 1984, now U.S. Pat. No. 4,648,880.
The present invention relates to improved implantable prostheses which resist spherical capsular contracture. More particularly, the invention pertains to improved prosthetic devices for rescoring or improving normal body contour or augmenting as well as reconstructing the female breast. It may also be used to augment or reconstructing tissue on various locations on the human body.
In recent years one of the most popular implantable procedures was a gel-filled silicon bag. This prosthesis has been employed for a number of years for breat augmentation and reconstruction. In. U.S. Pat. No. 3,293,663 to Cronin, the breast prosthesis comprises (1) a flexible container approximating the shape of the human breast, (2) a soft gel filling said container, and (3) a layer of porous material attached to one side of said container so that the tissue can grow into said porous material to another the prosthesis to the chest wall.
U.S. Pat. Nos. 4,205,401 to Frisch and 4,264,990 to Hamas reveals that when a Cronin-type of prosthesis is implanted after a certain period of time the prosthesis is surrounded by a natural capsule composed of fibrous scar tissue. Although this is a normal tissue reaction to the presence of a foreign body, it has the disadvantage in that the scar may undergo contraction during the healing process. This effect, which is known as the sperical contracture of the prosthesis, leads to a relatively rigid and tense structure. More specifically, as the tissue around the implant contracts the fixed volume of the silicon gel and material within the flexible container is forced into a shape having the smallest possible surface area, i.e. a sphere surrounded by essentially scar tissue. As pointed as by Frisch, the resulting hard spherical prosthesis results in an aesthically undesirable breast.
Both the Frisch and Hamas disclose various prior art efforts to overcome the spherical capsular contracture problem. Disadvantages of the piror art suggestions are also discussed by the patentees. Frisch's invention is to resist capsular contracture by employing a flexible container which has structural restraining means positioned within the container or the container walls which function to restrain the scar tissue pressure. On the other hand, Hamas proposes the use of a special flexible backing of an inert polymeric material which defines passageways and/or compartments into which a second material may be injected or already placed to rigidfy the backing. This is somewhat of an attempted improvement over the Cronin device which uses a back porous layer such as a Dacron fabric. There are many other proposed suggestions, but they were also found to have disadvantages and flaws.
Thus,the devices heretofore proposed for overcoming the capsular contracture problem has not been found to be effective. It is also very important that the implant can be readily removed in its entirety from the human body in the even that an infection or undesirable reaction to the implant occurs or should total repositioning or total removal be desired for whatever reason.
The present invention is directed to improved implantable prosthesis for use in the human body comprising a flexible container with a soft gel or fluid filling and an outer plastic or polymeric covering bonded to the flexible container and substantially encompassing said container. The outer plastic polymeric covering is made from Dacron or Teflon and has numerous pores or interstices as well as a rough textured external surface. It is also possible to employ a barrier film or membrane disposed between the flexible container and the outer covering or positioned within the flexible container.
One object of the present invention to provide an implantable prosthesis whichg will disperse or disorganize the force of encapsulating tissue sufficient to avoid formation of a spherical capsular contracture.
Another object of the present invention is to provide an implantable prosthesis which can readily be removed in its entirety, if desired, from the human body without encountering any untoward affects.
A further object of the present invention is to provide an improved mammary prosthesis which avoids or substantially decreases the formation of a spherical capsular contracture.
The above objects and advantages of the present invention will be more fully understood by reference to the following description and to the annexed drawing, in which:
FIG. 1 shows an implantable breast prosthesis having a soft gel filling a flexible container and an outer covering with a rough textured external surface.
FIG. 2 shows an implantable breast prosthesis having a soft gel filling, a barrier film, a flexible container, and an outer covering with a rough textured external surface.
The invention will be described more specifically with respect to a mammary proshesis including a flexible container, envelope, or sac filled with a gel or any of the other conventional materials utilized in this art. The flexible container is formed of a flexible silicon rubber or Silastic membrane and the gel, for example, is a semi-fluid silicone or liquid methylsiloxane resin capable of having a consistency which will provide resiliency and maintain the proper contour of the container. As known in the art, any suitable materials which do not cause tissue reaction and which are soft and flexible can be utilized for these purposes. For the present purposes, however, the preferred material for the flexible material is silicon rubber while the preferred gel is a silicon gel. Such material will often exhibit an elastic memory. The disclosure in column 2, line 32-46, of U.S. Pat. No. 3,293,663 is incorporated herein by reference with respect to the gel material that can be employed.
The container itself may be formed of a physiological inert elastomeric material which includes a number of known plastics. As previously stated, the use of silicon rubber is preferred, but for certain purposes organic rubbers made from butyl polymer or the natural polymer from the Hevea tree could be effectively employed. The use of dimethylsiloxane polymer to form the flexible container is also encompassed.
The thickness of the container wall will generally range from about 0.025 to 0.5 millimeters, but it can vary widely. In general, the flexible contianer is filled with a silicon gel or, if desired, with the saline solutions which have been recently proposed for this purpose, in amounts sufficiant to give the prosthesis a pilant, responsive nature as well as the desired profile.
A conventional barrier, film or membrane may be bonded laminated or adhesively connected to the internal or external wall of the flexible container to eliminate any seepage of the filler material out of the wall of the flexible container. It may be made of materials such as a vinyldene fluoridehexafluoropropylene-based fluoro-rubber as disclosed in U.S. Pat. No. 4,413,359.
The essential feature of the present invention is the use of an outer plastic or polymeric covering for the flexible bag or the flexible bag provided with a barrier film or membrane. Thus, the nature of the flexible container, the material used to fill it, and the barrier film are less important than the external surface of the plastic or polymeric covering as well as its nature. In order to overcome the spherical capsular contracture discussed above, the external or outer surface of the polymeric film or plastic film has to be rough textured as well as being able to permit tissue ingrowth. Thus, the rough texture of the external surface, which will have pores or interstices, will break up the orderly alignment of the collagen fibers in the scar or fibrous capsule surrounding the implanted prostesis. Although at this time it is not fully understood how this outer covering with the special external surface functions, it is believed that it is the orderly alignment of the collagen in the fibrous capsules around the smooth prosthesis implant which cause spherical capsular contraction. In the present invention this orderly alignment is disrupted or disorganized.
In accordance with another feature of the present invention it has been found that despite the rough textured external surface of the outer convering the implant can be completely removed without any problems in the event of an infection or otherwise indicated or undesired.
The preferred material for use as the outer covering is polyester fibers such as Dacron which is a polymerized ethylene glycol terephthalate. Although the polyester fiber may be woven, knitted, braided or formed into felt; the use of knitted polyester fiber is found to be superior because it provides more elasticity and tissue in growth. Knitted Dacron velour is the especially preferred material, since the velour structure may further assist in disrupting or disorganizing the orderly alignment of the collagen fibers. It may be crimped to additional elasticity.
In accordance with another feature of this invention it has been found that tetrafluoroethylene polymer such as Teflon, can also be utilized for the purposes of preparing an improved implantable prosthesis which will resist spherical capsular contracture. The polymeric material is most useful when it is employed in its expanded from. Such an expanded Teflon is sold commercially under the name Gortex.
The outer covering will of course be bonded, laminated or adhesively secured to the flexible container or to the outer surface of the intermediate barrier film when the later is employed in this position. The thickness of the outer covering and may vary over a wide range. Thus, for example, it may have a thickness of from about 0.01 to 1 millimeter. By a "rough textured" outer surface it is meant that the external surface of the outer covering will, by its nature, have numerous pores and/or interstices. If velour is used, fibers will project out from the external surface of the covering. Both the size and number of the pores and interstices may vary, but it is important that substantial pores and/or interstices be present in order to obtain the desired benefit or the present invention.
Although the invention has been described above with respect to certain of its more important features, it will be understood that the invention is subject to variations and modifications without departing from its broader scope. Thus, for example, in addition to mammary prosthesis the improved implantable devices of this invention can also be used for different shapes and forms for the purpose of augmenting tissue anywhere on the animal or human body for aestetic and reconstructive purposes. Augmentation of tissue include augmentation of hypoplastic or missing tissure for reconstructive purposes as well as the augmentation of tissue for aesthetic purposes. It is also possible, for example, to use silicone foam or a rough textured silicon envelope as the external covering, but at the present time they are not preferred materials for the present purposes.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3559214 *||Oct 17, 1968||Feb 2, 1971||Pangman William J||Compound prosthesis|
|US3700380 *||Oct 1, 1970||Oct 24, 1972||Tecna Corp||Surface or lining compatible with blood or other tissue|
|US4413359 *||Feb 26, 1982||Nov 8, 1983||Koken Co., Ltd.||Impermeable laminate membrane|
|US4455691 *||Oct 3, 1979||Jun 26, 1984||Minnesota Mining And Manufacturing Company||Silicone gel filled prosthesis|
|1||Barton, Jr., "Augmentation Mammaplasty" Selected Readings in Plastic Surgery, vol. 3, No. 29 (Dec. 1985) pp. 1-17.|
|2||*||Barton, Jr., Augmentation Mammaplasty Selected Readings in Plastic Surgery, vol. 3, No. 29 (Dec. 1985) pp. 1 17.|
|3||Elizabeth Ann Powell, "Changes in the Subcutaneous Tissue Response Caused by Implant Compliance and Surface Morphology", Case Western Reserve University, Cleveland, Ohio, May 1982.|
|4||*||Elizabeth Ann Powell, Changes in the Subcutaneous Tissue Response Caused by Implant Compliance and Surface Morphology , Case Western Reserve University, Cleveland, Ohio, May 1982.|
|5||McGhan, "Intrashield Mammary Implant" Medical brochure of McGhan Med. Corp. Santa Barbara, CA, Apr. 1980.|
|6||*||McGhan, Intrashield Mammary Implant Medical brochure of McGhan Med. Corp. Santa Barbara, CA, Apr. 1980.|
|7||Picha & Siedlak, "Ion-Beam Microtexturing of Biomaterials" Med. Dev. & D.I., vol. 6, No. 4 (Apr. 1984) pp. 39-42.|
|8||*||Picha & Siedlak, Ion Beam Microtexturing of Biomaterials Med. Dev. & D.I., vol. 6, No. 4 (Apr. 1984) pp. 39 42.|
|9||Taylor & Gibbons, "Effect of Surface Texture . . . " Jr of Biomedical Materials Research, vol. 17, (1983), pp. 205-207, John Wiley & Sons.|
|10||*||Taylor & Gibbons, Effect of Surface Texture . . . Jr of Biomedical Materials Research, vol. 17, (1983), pp. 205 207, John Wiley & Sons.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US6214045 *||Oct 9, 1998||Apr 10, 2001||John D. Corbitt, Jr.||Bioabsorbable breast implant|
|US6436143 *||May 12, 2000||Aug 20, 2002||Anthony C. Ross||Method and apparatus for treating intervertebral disks|
|US6605116||Apr 3, 2001||Aug 12, 2003||Mentor Corporation||Reinforced radius mammary prostheses and soft tissue expanders|
|US6638308||Apr 10, 2001||Oct 28, 2003||John D. Corbitt, Jr.||Bioabsorbable breast implant|
|US6881226||Jul 28, 2003||Apr 19, 2005||John D. Corbitt, Jr.||Bioabsorbable breast implant|
|US7244270||Sep 16, 2004||Jul 17, 2007||Evera Medical||Systems and devices for soft tissue augmentation|
|US7637948||Apr 19, 2005||Dec 29, 2009||Senorx, Inc.||Tissue marking implant|
|US7641688||Dec 22, 2005||Jan 5, 2010||Evera Medical, Inc.||Tissue augmentation device|
|US7645475||Mar 3, 2005||Jan 12, 2010||Mentor Corporation||Devices having a textured surface|
|US7846205 *||Sep 1, 2004||Dec 7, 2010||Brennan William A||System and method for breast augmentation|
|US7871438||Oct 23, 2009||Jan 18, 2011||Senorx, Inc.||Tissue marking implant|
|US7998201||Sep 30, 2008||Aug 16, 2011||Evera Medical, Inc.||Methods of forming a tissue implant having a tissue contacting layer held under compression|
|US7998202||Sep 30, 2008||Aug 16, 2011||Evera Medical, Inc.||Tissue implant having a biased layer and compliance that simulates tissue|
|US8092527||Jan 29, 2007||Jan 10, 2012||Brennan William A||System and method for breast augmentation|
|US8157862||Dec 10, 2010||Apr 17, 2012||Senorx, Inc.||Tissue marking implant|
|US8177792||Nov 18, 2009||May 15, 2012||Senorx, Inc.||Plugged tip delivery tube for marker placement|
|US8202316||Jan 28, 2009||Jun 19, 2012||Ledergerber Walter J||Modulating buttress saline mammary prosthesis|
|US8219182||Jul 10, 2012||Senorx, Inc.||Cavity-filling biopsy site markers|
|US8224424||Jul 13, 2009||Jul 17, 2012||Senorx, Inc.||Tissue site markers for in vivo imaging|
|US8277391||Aug 7, 2002||Oct 2, 2012||Devicor Medical Products, Inc.||Methods and devices for defining and marking tissue|
|US8288745||Apr 28, 2008||Oct 16, 2012||Senorx, Inc.||Method of utilizing an implant for targeting external beam radiation|
|US8311610||Jan 22, 2009||Nov 13, 2012||C. R. Bard, Inc.||Biopsy tissue marker|
|US8361082||Mar 1, 2011||Jan 29, 2013||Senorx, Inc.||Marker delivery device with releasable plug|
|US8401622||Dec 17, 2007||Mar 19, 2013||C. R. Bard, Inc.||Biopsy marker with in situ-generated imaging properties|
|US8437834||Sep 28, 2011||May 7, 2013||C. R. Bard, Inc.||Breast marker|
|US8447386||Dec 14, 2010||May 21, 2013||Senorx, Inc.||Marker or filler forming fluid|
|US8486028||Sep 30, 2011||Jul 16, 2013||Bard Peripheral Vascular, Inc.||Tissue marking apparatus having drug-eluting tissue marker|
|US8498693||Apr 8, 2011||Jul 30, 2013||Senorx, Inc.||Intracorporeal marker and marker delivery device|
|US8506627||Aug 12, 2009||Aug 13, 2013||Allergan, Inc.||Soft filled prosthesis shell with discrete fixation surfaces|
|US8541764||Aug 6, 2012||Sep 24, 2013||Senorx, Inc.||Method of utilizing an implant for targeting external beam radiation|
|US8546458||Dec 7, 2011||Oct 1, 2013||Allergan, Inc.||Process for texturing materials|
|US8579931||Sep 29, 2011||Nov 12, 2013||Bard Peripheral Vascular, Inc.||Apparatus for the percutaneous marking of a lesion|
|US8626269||Jun 8, 2011||Jan 7, 2014||Senorx, Inc.||Fibrous marker and intracorporeal delivery thereof|
|US8626270||Jun 13, 2012||Jan 7, 2014||Senorx, Inc.||Cavity-filling biopsy site markers|
|US8634899||Feb 3, 2006||Jan 21, 2014||Bard Peripheral Vascular, Inc.||Multi mode imaging marker|
|US8639315||May 16, 2013||Jan 28, 2014||Senorx, Inc.||Marker or filler forming fluid|
|US8668737||Mar 21, 2012||Mar 11, 2014||Senorx, Inc.||Tissue marking implant|
|US8670818||Dec 30, 2008||Mar 11, 2014||C. R. Bard, Inc.||Marker delivery device for tissue marker placement|
|US8679279||Nov 15, 2011||Mar 25, 2014||Allergan, Inc.||Methods for creating foam-like texture|
|US8679570||Apr 25, 2011||Mar 25, 2014||Allergan, Inc.||Foam-like materials and methods for producing same|
|US8680498||Sep 9, 2013||Mar 25, 2014||Senorx, Inc.||Method of utilizing an implant in a human breast|
|US8685296||May 10, 2011||Apr 1, 2014||Allergan, Inc.||Porogen compositions, method of making and uses|
|US8718745||May 25, 2010||May 6, 2014||Senorx, Inc.||Tissue site markers for in vivo imaging|
|US8784433||Apr 27, 2012||Jul 22, 2014||Senorx, Inc.||Plugged tip delivery tube for marker placement|
|US8877822||Sep 27, 2011||Nov 4, 2014||Allergan, Inc.||Porogen compositions, methods of making and uses|
|US8880154||Jul 19, 2013||Nov 4, 2014||Senorx, Inc.||Fibrous marker and intracorporeal delivery thereof|
|US8889751||Sep 28, 2011||Nov 18, 2014||Allergan, Inc.||Porous materials, methods of making and uses|
|US8911765||Mar 28, 2008||Dec 16, 2014||Tyrx, Inc.||Biodegradable, polymer coverings for breast implants|
|US8951596||Jul 15, 2013||Feb 10, 2015||Allergan, Inc.||Implants and methods for manufacturing same|
|US8965486||Dec 6, 2013||Feb 24, 2015||Senorx, Inc.||Cavity filling biopsy site markers|
|US9039763||Jan 28, 2014||May 26, 2015||Senorx, Inc.||Tissue marking implant|
|US9042965||Mar 6, 2013||May 26, 2015||C. R. Bard, Inc.||Biopsy marker with in situ-generated imaging properties|
|US9044162||Jan 25, 2013||Jun 2, 2015||Senorx, Inc.||Marker delivery device with releasable plug|
|US9044897||Sep 28, 2011||Jun 2, 2015||Allergan, Inc.||Porous materials, methods of making and uses|
|US9072821||Feb 4, 2011||Jul 7, 2015||Allergan, Inc.||Biocompatible structures and compositions|
|US9138308||Aug 2, 2012||Sep 22, 2015||Apollo Endosurgery, Inc.||Mucosal tissue adhesion via textured surface|
|US9138311||Jul 29, 2013||Sep 22, 2015||Allergan, Inc.||Soft filled prosthesis shell with discrete fixation surfaces|
|US9149341||Nov 21, 2011||Oct 6, 2015||Senorx, Inc||Deployment of polysaccharide markers for treating a site within a patient|
|US9155613||Feb 6, 2014||Oct 13, 2015||Allergan, Inc.||Methods for creating foam-like texture|
|US20030093151 *||Dec 19, 2002||May 15, 2003||Guangzhou Wanhe Material Co. Ltd.||Implantable mammary prosthesis with flexible sheet|
|US20050055093 *||Sep 1, 2004||Mar 10, 2005||Brennan William A.||System and method for breast augmentation|
|US20050187624 *||Apr 19, 2005||Aug 25, 2005||Corbitt John D.Jr.||Tissue marking implant|
|US20050216094 *||Mar 3, 2005||Sep 29, 2005||Prewett Donovan D||Devices having a textured surface|
|US20060058890 *||Sep 16, 2004||Mar 16, 2006||Lesh Michael D||Methods for soft tissue augmentation|
|US20070123983 *||Jan 29, 2007||May 31, 2007||Brennan William A||System and method for breast augmentation|
|US20080241212 *||Mar 28, 2008||Oct 2, 2008||Tyrx Pharma, Inc.||Biodegradable, Polymer Coverings for Breast Implants|
|US20080281388 *||Apr 28, 2008||Nov 13, 2008||John Corbitt||Method of utilizing an implant for targeting external beam radiation|
|US20080294039 *||Apr 29, 2008||Nov 27, 2008||Senorx, Inc.||Assembly with hemostatic and radiographically detectable pellets|
|USD715442||Sep 24, 2013||Oct 14, 2014||C. R. Bard, Inc.||Tissue marker for intracorporeal site identification|
|USD715942||Sep 24, 2013||Oct 21, 2014||C. R. Bard, Inc.||Tissue marker for intracorporeal site identification|
|USD716450||Sep 24, 2013||Oct 28, 2014||C. R. Bard, Inc.||Tissue marker for intracorporeal site identification|
|USD716451||Sep 24, 2013||Oct 28, 2014||C. R. Bard, Inc.||Tissue marker for intracorporeal site identification|
|USRE43434||Aug 20, 2004||May 29, 2012||Ross Anthony C||Method and apparatus for treating intervertebral disks|
|WO2008121816A2||Mar 28, 2008||Oct 9, 2008||Tyrx Pharma Inc||Biodegradable, polymer coverings for breast implants|
|International Classification||A61L27/14, A61F2/12, A61L27/34, A61F2/00|
|Cooperative Classification||A61F2/12, A61F2/0077, A61L27/14, A61L27/34|
|European Classification||A61L27/34, A61L27/14, A61F2/00L, A61F2/12|
|Apr 15, 1998||FPAY||Fee payment|
Year of fee payment: 8
|Nov 19, 2001||FPAY||Fee payment|
Year of fee payment: 12
|Feb 11, 2005||AS||Assignment|