WO2011058550A1

WO2011058550A1 - Female Breast Implants

Info

Publication number: WO2011058550A1
Application number: PCT/IL2010/000928
Authority: WO
Inventors: Itay Rozenman
Original assignee: Rolan Knowledge And Services Ltd.
Priority date: 2009-11-16
Filing date: 2010-11-09
Publication date: 2011-05-19
Also published as: IL202160A0

Abstract

The present invention relates to female breast implants for cosmetic purposes, for shaping and/or augmenting breasts, and/or for reconstruction purposes, for totally or partially reconstructing breasts that have been gravely damaged, possibly destroyed, by accident or by surgery e.g. for the removal of cancerous tissue. More particularly the present invention relates to implant for female breasts, which comprises an envelope and a filling, and wherein the filling comprises a gaseous phase.

Description

Female Breast Implants

Field of the Invention

This invention relates to female breast implants for cosmetic purposes, viz. for shaping and/or augmenting breasts, and/or for reconstruction purposes, viz. for totally or partially reconstructing breasts that have been gravely damaged, possibly destroyed, by accident or by surgery e.g. for the removal of cancerous tissue.

Background of the Invention

The use of breast implants for cosmetic or reconstruction purposes is generally known in the art. There are however major disagreements as to the specific type of the implants. Two types of implants, that are widely known and used, are those containing silicone gel or saline solution. However, the art finds serious drawbacks to both. In both the contents are liable to leak or bleed with time and to cause medical damage to the persons using them. They are heavy and tend to succumb to gravity and become droopy. Both kinds are radiopaque thus impeding routine mammography exams.

The literature deals extensively with defects and dangers of breast implants (see www.naturalprofiles.com/breast-implants-gone-bad.html):

"... most.new surgeries yield unnatural results. In many cases women find that their bodies do not take well to the implants and even with a successful surgery they don't look quite right"

Also, not all implants are permanent, and additional surgery might be required throughout the patient's life. he implants of this invention are less liable to suffer from those defects. Summary of the Invention

The implants of this invention comprise an envelope and a filling, wherein the filling is constituted entirely, or in substantial and preferably predominant portion, by a gas of low molecular weight, preferably helium. The nature and amount of said filling that is not low-molecular weight gas depends in each case on the particular purpose of the specific implant in question, as will appear hereinafter. Traces of atmosphere may remain within the implant as consequence of the way in which it has been made.

The envelope may be multilayered; the outermost layer is for example the silicon or polyurethane known in the art. It is essentially non distensible and will resist volume changes which usually occur as a result of pressure changes. For example, in conditions of low atmospheric pressure which occur in high altitudes and will increase the volume of distensible implants.

Additionally the envelope is essentially impervious to the gas filler whether helium or heavier, for example perfluorocarbon.

Each implant may serve cosmetic purposes, such as mastopexy or augmentation, or reconstruction purposes, wherein they may be part of reconstruction, such as after mastectomy or partial or total removal of the breast by accident or surgery. In the first case the implant envelope may be and generally will be constituted, at least prevalently, by at least one artificial, generally polymeric, layer and there may be a plurality of implants. In the second case, a single implant will generally be used for each breast and will define the volume of the reconstructed breast. It will be covered all around by layers of living host tissue.

An important property that may be required of the envelope is that it, or parts of it, be self-sealing. A structural component will be deemed herein to be self- sealing when it automatically closes, possibly with the assistance of pressure and/or heat, any perforation that is small, preferably but not necessarily having linear dimensions up to one millimeter, such as caused by a sharp needle. Said property is particularly required when the filling has been reduced with time in an existing implant and should be reported to its proper amount. Elastic polymers, natural or artificial rubber may be self-sealing Example of items with self-sealing properties are plastic containers for infusions or plastic caps of medicine bottle which self seal themselves after a needle is inserted . If the envelope is not self- sealing, an additional patch of any suitable shape of a material that is self-sealing may be attached to it, e.g. adhesively, any needed perforations will be carried out through said patch and will be self-sealed, whereby to screen the underlying perforation that will not be sealed.

Various processes are available for making the implants of the invention. For instance, a flat sheet may be generated; pieces of the appropriate shape may be cut from it and connected to make a flat/deflated pocket that will form the implant envelope. The filling gas, e.g. helium, may be injected into said pocket in the quantity required to form the desired filling, and the envelope may be sealed or allowed to seal. Alternatively, a thermoplastic material may be extruded to form the envelope from an extruder provided with an addition nozzle, a gas may be fed through said addition nozzle to form the filling by extruding it inside the envelope as it is formed by extrusion of said material, and finally said envelope may be sealed or allowed to seal. If a sufficient amount of the original skin and connective tissue remains, the envelope material may be extruded or otherwise shaped, the filling gas may fed inside said envelope in such a way and quantity as to replace all or most of the unwanted gas it contains and, if required, to press said envelope material against said connective tissue to form the desired envelope, which finally may be sealed or allowed to seal.

An additional envelope layer may also be created by dipping an implant having the proper desired shape into a solution containing a solute that will form, upon drying/polymerization an outer skin about the implant and over its-envelope, or dipping the implant into a liquid that will form, upon drying/polymerization, such an outer skin. In this way one may create a two-layer, or even a multiple-layer, envelope, which will render the implant as gas-tight as possible and also increase its resistance to volume changes under pressure. Alternatively, the liquid or solution into which the implant is dipped may be absorbed by the original envelope, so that upon drying they will not be formed an additional, outer envelope, but will modify the physical properties of the existing envelope, e.g. increase its resistance to pressure or its capability of sealing the implant content against the outside and preventing leakage of said content or penetration of other substances from the outside into the implant. Several of the above effects of dipping, or all said effects, may be achieved together.

Many process variations or alternatives may be devised by skilled persons without departing from the characteristic elements of the invention.

A factor to be considered when designing implants is the weight. Heavy implants will favor and may even cause gradual sagging. Light implants will prevent sagging. A light envelope with a helium filling (hydrogen being obviously out of the question) makes the lightest implants. Heavier gases may be added, nitrogen and C02 or perfluorocarbon being possible examples. More impervious envelopes may be double envelopes, with layers made of different materials, silicone envelopes, envelopes made out of other polymers, to stop as much gas as possible from leaking out through the envelope.

The following are among the most important advantages of the invention:

1. Conventional breast implants are filled with silicone gel, are generally radiopaque and therefore interfere with the proper X-ray breast imaging which is very important for early detection of breast cancer, obviously a major disadvantage. The gas which fills the implant of the present invention, as opposed to silicone which fills the conventional breast implant renders the implant more X-ray transparent (radiolucent) and will better allow regular breast scanning / imaging (mammography) for early detection of breast cancer.

2. Said implants are impervious to filling "bleeding" outside the envelope in the human body,

3. Said implants are very light and will not succumb to gravity and will not sag with time. 4. They will be made from such non distensible material that their volume is not affected by external pressure - for example during flight.

5. This implant can be introduced into the surgical pocket under the breast through a smaller than currently used skin incision, since it will be introduced empty and deflated into position in the breast and will be filled to the desired volume while in the breast, through a nozzle which can derive from the way the envelope is generated or can be created afterwards.

6. The volume of this implant can be changed post-implantation according to the patient's desire. Gas can be added or withdrawn through said nozzle or through the self-sealing area in the envelope / patch.

7. The implant which has a very low weight renders the breast less mobile and less droopy thereby serve as an internal support to the breast and obviate the need for a bra.

Detailed Description of Preferred Embodiments

List of figures:

Fig.1 : Coronal section through the implant.

Fig. 2: Sagital section through a subpectoral implant in situ.

Fig. 3: Sagital section through-a reconstructed breast implant in situ.

Fig-. 3 a: The multilayered envelope of the implant drawn in 3b.

Fig. 3b: A section through a multilayered implant.

Fig. 4: A section through an implant with a front pad.

Fig. 5: The implant with self sealing layers attached to the inside of the envelope.

Fig. 6: An implant with a self sealing inflation duct and nozzle.

Some of the many embodiments of the invention will now be described for illustrative purposes and without in any way limiting the scope of the invention defined by the appended claims. Example 1

Fig. 1 shows a cross-section of implant 1 immediately after being made, not yet inserted into a breast. The implant is yet in a sphere-like form with an envelope 1 and a gaseous filling 2. When the implant is mounted in a breast, it will be subject to different pressures depending on the situation of the specific breast, which are different from case to case and are not illustrated in Fig. 1.

Example 2

Fig. 2 is a schematic sagital cross-section of a breast after implantation. Number 4 indicates the chest wall; number 5 the pectoralis muscles; number 6 the skin; and number 7 the underlying connective tissue and breast gland. Number 1 indicates an envelop of an implant such as that of Fig. 1, number 2 the filling of said implant.

Example 3

Fig. 3 shows a breast reconstructed after complete damage. Number 6 is the patient's skin layer. Number 1 1 is the appropriate implant for the reconstruction of the breast, which implant has an envelope 1 and a filling 2. The envelope has been so shaped as to impart to the reconstructed breast the desired outwardly shape, and may be multi-layer though this is not shown in Fig. 3, while a small portion of an example of it is schematically shown at 14 in Fig.3a and consists in four layers a,b,c,d. The same layers are shown in Fig. 3b and indicated with the same letters. For example, the outermost layer may be made of silicone, while the other layers may comprise, in any desired succession, layers of Teflon (polytetrafluoroethylene) or aluminized Teflon, Mylar or aluminized Mylar, Kapton, Vectran, Kevlar, polyurethane, polyethylene, polyester, particularly polyethylene terephthalate. The thickness of the envelope or its component layers may vary from a few microns to hundreds of microns.

Another layer which has been shown to be very impervious is a single layer of graphene which can be used as one of the layers in the envelope of the present invention.

A good way of making multi-layer envelopes, according to a process aspect of the invention, is by dipping, once or more than once, an implant, already provided with an envelope, into a liquid or a solution and allowing the wet envelope to dry after each dripping, whereby the outer liquid layer resulting from the dipping forms an outer solid / resilient layer of the same substance that constituted the liquid or of the solute if the liquid was a solution. The original envelope of the implant can have been created by any process, and if created by extrusion the material of the implant may even have been extruded directly into the above liquid.

)

Example 4

Fig.4 schematically illustrates an implant such as that of Fig. 3, which however is provided with a surface / front pad 15 of a material that is adequately soft and elastic to give the breast a good feeling, preferable to the hard feeling that would be given by the surface 16 of envelope 1 in fig. 3, if exposed.

Example 5

Fig.5 illustrates an implant with an envelope 1 which is not self-sealing and is therefore provided with a self-sealing attachment 18 or a plurality of such attachments that adhere to said envelope so that if envelope 1 is perforated the perforation will be sealed by one such attachment.

' Example 6

Fig. 6 schematically illustrates an implant having an envelope 1 that is not self- sealing and is provided with a duct 22 having a nozzle 23. When implant 20 is mounted in place, duct 22 is placed in such a position that nozzle 23 can easily be reached from the outside, gas can be injected through duct 22, and nozzle 23 can be self-sealed when the injection has been accomplished.

The above examples are illustrative but not limitative and the invention may be carried into practice in any other ways comprised in the attached claims.

Claims

1. Implant for female breasts, which comprises an envelope and a filling, and wherein the filling comprises a gaseous phase.

2. Implant according to claim 1 , wherein the filling is prevalently constituted by a gas or a mixture of gases.

3. Implant according to claim 2, wherein the gas or mixture of gases is prevalently of low-molecular weight.

4. Implant according to claim 3, wherein the low-molecular gas is helium.

5. Implant according to claim 1 , wherein the envelope is self-sealing or carries a self-sealing attachment.

6. Implant according to claim 1, wherein the envelope carries an inlet duct for the injection / withdrawal (inflation / deflation) of gas.

7. Implant for the cosmetic / reconstruction of female breasts, which comprises an envelope and a filling at least prevalently constituted by gas, and has a profile defining the shape of the implanted / reconstructed breast.

8. Implant according to claim 1, wherein the envelope is multilayer.

9. Implant according to claim 6, further comprising a self sealing front pad of the desired elasticity covering the front thereof.

10. Implant according to claim 1, wherein the envelope is resistant to pressure elongation / distention to which it may be subjected in use.

1 1. Implant according to claim 1, wherein the envelope is impervious to any outwardly leak of the implant contents and to any penetration of the surrounding contents.

12. Implants for female breasts, substantially as described and illustrated.

13. Methods for making implants for female breasts, which comprises the steps of making a substantially empty envelope and intruding therein a gas or mixture of gases until a desired volume / pressure is reached.

14. Methods for making implants for female breasts, which, comprises concurrently forming an envelope and injecting a gas or a mixture of gases unto it.

15. Methods for improving implants for female breasts, which comprises dipping an implant into a liquid or a solution and allowing said liquid or the solvent of said solution to evaporate or polymerize and repeating said process as desired to produce a multilayer envelope.

16. Methods for making implants for female breasts having very low weight and providing an internal breast support obviating the use of a bra.

17. Methods for making implants for female breasts, substantially as described and illustrated.