WO2010136840A2

WO2010136840A2 - Breast prosthesis having a position indicator and a textured base and including a peripheral reinforcing ring

Info

Publication number: WO2010136840A2
Application number: PCT/IB2009/005866
Authority: WO
Inventors: Ernesto Miguel Andrade Carrasco
Original assignee: Ernesto Miguel Andrade Carrasco
Priority date: 2009-05-27
Filing date: 2009-05-27
Publication date: 2010-12-02
Also published as: WO2010136840A3

Abstract

The invention relates, in general, to a breast prosthesis having a position indicator and a textured base and including a peripheral ring. In particular, the invention comprises a breast prosthesis including a cover or shell with a hollow interior and made from an elastic material, whereby the front face of said cover forms a dome and the rear face thereof forms the base, thereby forming a body having a similar shape to that of the female breast, which body is filled and sealed and includes a symmetrically centred tip on the dome. Said tip serves as a guide point positioning element in order to facilitate the positioning of the implant inside the breast pocket during implantation. In addition, the base has a different texture to that of the surface of the dome in order to improve adhesion to the base of the breast pocket. The invention further includes a peripheral reinforcing ring which encircles and seals the intersection between the dome and the base, with the purpose of strengthening the points subjected to the most stress during implantation, in order to reduce any loss of projection of the implants while inside the breast pocket.

Description

BREASTFEEDING WITH POSITION INDICATOR AND TEXTURIZED BASE THAT INCLUDES A PERIMETER RING OF

REINFORCEMENT

D E S C R I P C I Ó N

OBJECT OF THE INVENTION

This invention is generally related to a breast prosthesis with position indicator and textured base that includes a perimeter ring. Particularly, the invention comprises a breast prosthesis constructed from a cover or envelope with an internal cavity, based on an elastic material, which has an anterior face that forms a dome and a posterior face that forms the base, a configuration body that resembles the female breast that is filled and closed tightly, which includes a symmetrically centered crest on the dome whose purpose is as a guide point positioning element, in order to facilitate the location of the implant within the breast pocket during

The implantation, additionally including in the base a different texturing configuration to the surface of the dome to improve the adherence to the base of the breast pocket, also including a perimeter reinforcement ring that closes and surrounds the intersection between the dome and the base, designed in order to improve the points of more effort during The implantation, as well as to reduce the loss of projection of the implants during the time spent in the breast pocket.

FIELD OF THE INVENTION

The present invention has application within the medical area, particularly for use in female breast augmentation surgeries by implanting breast prostheses. Likewise, the present invention relates to means for detecting the position of the implant during surgery, as well as guaranteeing the immobility of the prosthesis during use and increasing resistance to unwanted pressures and deformations. This invention is generally related to a breast prosthesis with position indicator and a textured area that includes a perimeter ring.

BACKGROUND OF THE INVENTION

The breast augmentation is the specific indication for breast implants. This surgical indication comes within the field of cosmetic reconstructive and plastic surgery.

In terms of breast prostheses, the developments date back more than 30 years. However, there are still incidents related to the surgical procedure, directly concerning the position of the implant, its adjustment, its changes of position within the breast bag during the term of use, etc.

US Patent US3852832 by McGhan et al. Discloses an implant prosthesis in the human body to fill a cavity where the prosthesis has a fixation means around which the tissue will grow to hold the prosthesis in place. An optional flexible, inelastic loop provides temporary fixation until the tissue has grown around the fixation means. The fixing means can be made of an elastomeric silicon, which is compatible with the fabric. The fixing means, for example, can take the form of a perforated body similar to a spaced sheet of the outer wall of the prosthesis, or of a body similar to a button supported by a stem to the outer wall. Although this solution provides for an arrangement that can benefit the immobility of the prosthesis, it is also known that not all tissues adequately accept and receive additional means such as portions increased in thickness with full texture changes.

Research has been done on elastic and resistant wraps with long-term reliability, as well as the use of high cohesive elastic filling gel. Despite these developments, they are not going aimed at the characteristics related to facilitating the surgical procedure and preventing future complications thereof.

Due to the technological development and the wide existing market for said product, it is determined to venture into the manufacture of breast implants that somehow guarantee effective surgical procedures.

Breast augmentation using breast implants should be performed in a surgical environment (surgery rooms) by surgeons specializing in plastic surgery. Among the surgical techniques, to perform this type of surgery, the surgeon must use routes of entry depending on the area of the scar. The most used route is the route of the halo (around the nipple). A second modality is the axillary route (in the axilla) and a third commonly used is the sub-mammary route practiced in the region in the lower fold of the bust.

As such, the implant must be placed in one of two sites available in the human body, the pre-pectoral located between the mammary gland and behind the large pectoral muscle; and, retro-pectoral, behind the mammary gland and behind the large pectoral muscle. As such, it is the responsibility of the surgeon to evaluate the size and shape of the implant, the site of the incision in the bust, the approach and the criteria for the positioning of the implant as a function of the patient's anatomy and the desired aesthetic results. A clear definition of the objectives will constitute an integral part of the preparation for surgery to ensure that there is a mutual understanding between the surgeon and his patient. The surgeon must comply with current surgical techniques to minimize the risk of an unwanted reaction.

Likewise, it has been concluded that there are no specific contraindications for the use of breast implants. However, there may be contraindications related to the conduct of a non-urgent surgical operation, such as instability, psychological instability may be a contraindication for surgery, pregnancy, tumor in the benign or malignant man, conditions that contraindicate any procedure Non-urgent surgical, such as biological, immunological, cardiovascular or respiratory abnormalities.

There are also some problems inherent in the body such as types of inappropriate or damaged tissue cover. On the other hand, another resident problem is that during the surgery, the breast implants can be damaged, so that an accidental traumatic rupture of the implant can occur as a result of undue pressures, perforations of the envelope with scissors, a needle or general instrumentation.

Another problem that is no less relevant is the incorrect positioning of the implant, both during surgery and in the term of life due to subcutaneous detachment of the implant, so that the body can reject it. With incorrect positions, additional circumstances such as loss of bust sensitivity may develop; and among many others, the retractable fibrosis. Improper positioning is caused by difficulty in orienting and locating the implant three-dimensionally during surgery, and by its subsequent mobility within the organism.

There are textured implants that are chosen based on the patient's needs. However, it has been discovered that breast implants with integral texturing are not suitable since the patient's breast bag tissue varies around it. In the same way if there is retractibility, any non-understandable body will tend to become spherical as a result of the retractibility of the surrounding fibrosis, since the area of the surface of the sphere is minimal for a given volume.

All implants will eventually lose their shape within the limits defined by the virtual space created by the implant positioning on the site (retrograndular or retropectoral). The two anterior or posterior sides of the implant are naturally more compressed than the circumference.

Thus, the recent needs of breast implants is the construction of an implant that presents possibilities to detect its position during surgery and that guarantees its immobility during its use, as well as additional elements so that the implant is effectively fixed to The breast bag.

There is also a need to define implants with effective reinforcements to avoid unwanted formations, capsules, pressures, etc. Therefore, a first object of the present invention is to avoid the disadvantages of the prior art. More particularly, an object of the present invention is to create an arrangement of an implant that presents possibilities to detect its position during surgery and that guarantees its immobility during its use. A no less important object of the arrangement of an implant that guarantees its immobility and is effectively fixed to the breast bag.

Additionally, another important object exists in the need to create an implant with effective reinforcements to avoid unwanted formations, capsules, pressures, etc.

The present invention meets these needs and provides other related advantages.

DESCRIPTION OF THE INVENTION

This invention generally relates to a breast prosthesis with position indicator and textured base that includes a perimeter ring.

DESCRIPTION OF THE FIGURES.

To further clarify the invention and its advantages compared to the known art, the possible forms of illustrative and non-limiting embodiments of the application of said principles are described below with the aid of the attached drawings. FIG. 1 Shows a side view of the breast implant of the present invention.

FIG. 2 Illustrates a front view of breast implant of the present invention. FIG. 3 Shows a rear view of breast implant of the present invention.

PREFERRED EMBODIMENT OF THE INVENTION.

Particularly, based on Figure 1, the invention comprises a breast prosthesis 1 constructed from a cover or envelope with inner cavity, based on an elastic material constituting a body 2.

According to figures 1, 2 and 3, said prosthesis 1 comprises a body 2 formed an anterior face that forms a dome 3 and a posterior face that forms the base 4, configuration body 2 that resembles the female breast. Said body 2 is gel filled. As such, the body is closed tightly, to the environment so that the gel must not be evacuated for any reason outside the implant.

According to the present invention, the body 2 of the implant includes a crest centered 5 symmetrically on the dome 3.

The purpose of said centered crest 5, is a guide point positioning element. From this guide point it is possible to verify by touch, the implant position in the breast bag during implantation, as well as the position with respect to the other side (symmetry) and other external anatomical reference points such as midline, sternum , clavicle, etc). Thus, its location is detectable and guaranteed.

Similarly, from this centered crest 5 during the use of the implant over the years, it is possible to guarantee its immobility so that it does not change its position with respect to the axis on which the implant should be positioned within the breast bag.

Likewise, to guarantee the end of life, the implant of the invention comprises a change in texturing.

For this purpose, the present invention includes in the base or dome or integral body assembly, a configuration of a texturing zone 6. In preferred embodiments, the texturing zone may comprise a configuration in the base different from the texturing of the surface of the dome to improve the adherence to the base of the breast pocket. This avoids subcutaneous detachment of the implant inside the breast pocket only in the back part that makes contact with the adjacent tissue.

As such, said texturing can comprise a corrugated surface or the like so that the subcutaneous tissue can adhere effectively. With this, it is also possible to guarantee the immobility that the implant does not rotate on its axis.

Likewise, said texturing may comprise a portion centered on the base 4 or said base may be textured on its entire surface.

On the other hand, the implant of the invention comprises a reinforcement ring 7 that surrounds perimetrically the intersection between dome 3 and base 4. This reinforcement ring is configured to improve the points of more effort that affects the implantation, to decrease the loss of projection of the implants during the time spent inside the breast pocket. Likewise, said reinforcement ring protects against the deformation forces of the capsular contracture and the pressures of the anatomical site where it is located, decreasing or preventing the deformity of the Implant during use. Said reinforcing ring 7 is configured so that it forms a lip that surrounds perimeter and reinforces the body of said prosthesis at the intersection between the dome and the base. As such, the implant of the present invention must comprise several sizes to balance the differences in the form of bust, offering the surgeon a wider range of options. The volumes vary from 210 to 575 cubic centimeters (ce.) For high profiles; These configurations are available with a smooth and textured surface.

Normally, the dome 3 and the base 4 that make up the body 2 are joined and sealed to each other by sealing by pneumatic pressure and temperature of the sealing discs.

The traceability of breast prostheses is individual, since each implant of the same manufacturing lot receives a specific number that indicates the manufacturing batch, and its characteristics. The implant is monitored at each stage of its manufacture by recording all the steps it has undergone and the established parameters.

To be able to track the implant throughout its life until its destruction and be able to record any incident that is produce, in the patch of each implant the essential information related to it must be recorded.

The implant filling product may comprise, not limited to, but by way of illustration, a silicone gel with a clear appearance, specific gravity @ 25 ⁰ C: 0.98; a refractive index @ 25 ⁰ C: 1,406; and, a penetration: 0.3 mm: 150.

Due to manufacturing needs, the silicone used is the product manufactured and sold by NUSIL Technology® (ISO 9001 certificate).

Claims

1. Breast prosthesis constructed from a cover or envelope with a sealed inner cavity that constitutes a body forming an anterior face that forms a dome and a posterior face that forms the base, characterized in that the implant body includes a crest symmetrically centered on the dome; and, a reinforcement ring that surrounds the intersection between the dome and the base perimeter.

2. Breast prosthesis according to claim 1 characterized in that said centered crest is a guide point positioning element.

3. Breast prosthesis according to claim 2 characterized in that additionally the dome comprises a textured area on its surface.

4. Breast prosthesis according to claim 2 characterized in that additionally the base comprises a textured area on its surface.

5. Breast prosthesis according to claim 2 characterized in that additionally the base and the dome comprise a textured area on its surface.

6. Breast prosthesis according to claim 3, 4 or 5 characterized in that the reinforcement ring is configured so that It forms a lip that surrounds perimeter and reinforces the body of said prosthesis at the intersection between the dome and the base.