MXPA97008078A - Fabric and implanta of seno permeable to flu - Google Patents

Abstract

The present invention relates to a prosthesis implant comprising a biocompatible fabric shell permeable to the growth of tissue and bodily fluids in the general configuration of a cone, a plurality of permeable partitions extending transversely within the shell and dividing the shell in a series of cameras and biocompatible fibrous masses placed inside said camera

Description

FABRIC AND IMPLANTA OF BREAST PERMEABLE TO FLUID Background of the Invention The present invention is directed to a prosthesis device and specifically to an improved composite prosthesis intended to be implanted in a female breast after separation of a diseased body tissue. Even more particularly, the invention is directed to a biocompatible breast implant characterized by following an initial period after implantation providing a patient with a close simulation to a natural breast.

Previous Technique Numerous attempts have been made to provide an implantable breast prosthesis that resembles both the patient and others, a close simulation of the normal breast. The use of liquid silicone implants is contraindicated in view of the harmful effects that can result from the silicone spill. Implants comprised of silicone bags filled with saline or the like are deficient in many aspects. Specifically, since the bag must only be partially filled to prevent rupture, the weight of the liquid forms the inadequate bag within visible folds. Also, the temperature of the liquid is retained for prolonged periods so that when the patient moves from a cold to a warm environment, for example, the implant will continue to feel cold. It is also possible, on exposure to the sun, that the actinic rays penetrate the bag and damage the tissues normally protected by the healthy breast. Attempts have been made to manufacture implants from biocompatible materials, for example DACRON (a registered trademark of Dupont Corporation). By way of example, 4,936,858 discloses a composite implant comprised of a biocompatible web-like bag comprising an additional bag filled with a gel in a silicone bag. The fabric material is selected to allow substantial growth of body tissues, to fix the prosthesis at the site of the implant. No. 3,293,633 discloses the use of a porous tissue-permeable polyester fabric secured to the back surface of a bag filled with silicone, the functioning fabric, to the growth of the fabric, to anchor the prosthesis. No. 3,189,921 discloses a foam-type implant having a sponge shell whose outer surface is permeable to fibrous tissue and blood, the shell having an inner surface that is permeable to body fluids but impermeable to the cellular structure. The reference notes that the implants of the prior art were undesirable in that they allowed the growth of fibrous tissues through the foam resulting in a hardening implant. Each of the approaches noted to provide a "natural" breast implant has failed, for one or more reasons, to achieve commercial success.

Brief Description of the Invention The present invention can be summarized as directed to a prosthesis device specifically intended for use as a breast implant and characterized in that it presents no risk to health, is not subject to migration from the implant site, is comfortable for the patient and presents , both from the point of view of appearance and touch, the characteristics of a natural female breast. An important feature of the device of the invention is that to a limited degree the implant is capable of increasing and decreasing its size in accordance with the gain or loss of weight of the patient. Since new blood vessels and tissue will develop through the structure of the device, normal body temperature will be maintained at the site of the structure in contrast to the prosthesis filled with known fluid that varies from body temperature when subjected to cold or cold environments. hot Briefly, the prosthesis device of the invention is comprised of a homopolymer polyester, Illustratively the identified Fortrel fiber, type 302 polyester, manufactured by WELLMAN INC. A feature of the device of the invention is that the prosthesis is comprised of a generally conical structure preferably of deformable warp knitted fabric internally subdivided into series of generally spaced apart parallel fabric separators which generally extend perpendicularly to the fabric. axis of the conical structure. The separators are preferably resistant to the stretched form of the interior of the structure in a series of chambers, the chambers each containing a filling of biocompatible fibers. The fibers and fabric that subdivide the chambers are selected in a manner that provides controlled permeability to both body tissues and tissue growth, tissue growth in particular being controlled by fiber density and to a lesser extent, the permeability of the spacers so that the growth of the tissue within several cells or chambers is greater in the previous chambers, the growth of the tissue within related chambers progressively in a subsequent manner being progressively less. The structure of the device is intended to promote a relatively high degree of tissue growth in the anterior chambers filled with lower density fiber with progressively smaller growth in the more densely packed fiber-filled chambers located posteriorly. More particularly, the fiber filling in the back chambers is effected to a higher density, with the respective chambers towards the anterior chamber or adjacent nipple which is filled to a lower fiber density. Both the external surface of the prosthesis and the spacers are permeable to body fluids, the external surface of the prosthesis which is preferably made of a type of compliant cord and, to a degree, the deformable knitted structure to ensure that the Rapid tissue growth provides stability to the device quickly after implantation. Accordingly, it is a primary object of the invention to provide a breast prosthesis that can be permanently implanted and that reproduces, as closely as possible, the characteristics of a natural breast. A further object of the invention is the provision of a prosthesis comprised of biocompatible fabrics that eliminate the disadvantageous aspects of the prostheses known hitherto. A further object of the invention is the provision of a breast prosthesis characterized in that it is divided into a series of progressively increasing base size chambers in the generally truncated conical configuration, further characterized in that the chambers are all receptive to growth of tissue as well as permeable to bodily fluids and in which the subsequently located chambers are filled with progressively denser fiber materials and are, therefore, less receptive to tissue growth than the chambers listed above thereby providing a device which reproduces closely the characteristic of a natural breast Another object of the invention is the provision of a prosthesis of the type described having an external surface comprised of corduroy knit material thereby promoting the rapid growth of tissue inside the knitting structure p to locate the prosthesis quickly and permanently A further object of the invention is the provision of a breast prosthesis that, to a certain degree, is enabled to expand and contract in accordance with the gain or loss of weight of the patient so that the body defines the shape of the structure, instead of the structure defining the shape of the body. Another object of the invention is the provision of a prosthesis of the type described that has a life expectancy coinciding with the life of the patient, to eliminate the need for adjustment or replacement as is the case with implants known so far Brief Description of the Drawings Fig. 1 is a schematic view of a prosthesis according to the invention implanted within the breast. Fig. 2 is a schematic enlarged plan view of a preferred knit material intended for use as the external component of the implant.

Detailed Description of the Drawings An implant or prosthesis 10 according to the invention is illustrated in Fig. 1. The details of the specific fibers and similar materials will be described in an additional section of the present application. Referring to Fig. 1, the prosthesis 10 is comprised of a generally conical configuration that includes a stretchable fabric of warp knitted fabric 11, the external configuration of the front portion 12 being generally configured in a convex manner that molds generally to the desired configuration of the external surface 13 of the sinus. As will be obvious, the size and shape of the prosthesis will be varied according to the patient's requirements. The interior of the prosthesis 10 is divided into a series of chambers 14, 15, 16, 17, 18 and 19 in the illustrative embodiment, it is understood that as many as two chambers can be provided and that 6 represents the maximum possible.

The chambers 14 to 19 are defined by transversely directed fabric separators 14 'to 18', the separators being less extensible than the fabric 11. The chambers 14 to 19 contain filler fibers as will be described more fully below, the fiber density within the chambers increasing progressively from the most anterior chamber 14 to the rearmost chamber 19, the fibers F as illustrated in Fig. 1 are schematically illustrated as being placed in parallel to illustrate the variations in concentration, it being understood that in the structure current fiber bundles are preferably oriented randomly. The dividing fabrics 14 'to 18' are comprised of permeable material, both to body fluids and to the growth of fibrous tissue. The outer fabric 12 is permeable in a manner similar to the fluid and the fabric growth, the fabric 12 preferably including an outer surface similar to corduroy or interlaced. For this purpose, Fig. 2 is described as a representative example, a plan view of a warp knitted fabric 12 a moving line of interlacing or braid stitches that are dotted to emphasize the defined wide interlaces 20 on the external surface of the braid as an inherent element thereof. While a warp knitting is illustrated, equally satisfactory results can be obtained by the use of a Raschel unit, the important characteristics of the fabric 12 being the extension capacity and the existence of similar external interlacing. While braided extensible fabrics are preferred, it is feasible to employ certain woven fabrics such as those described in U.S. Patent 4,892,539 issued to one of the inventors named herein, as well as U.S. Patent 4,517,687, both patents being incorporated herein by reference. It is understood that the fabrics of the cited patent references are used herein in an entirely different environment than that named by the patents and, specifically, are intended to be permeable to fluids and tissue growth in the current environment, considering that the environment described in the patents (vascular grafts) the tubular increases of the fabrics become impermeable by infusion with the blood of the patient which coagulates on the internal surfaces. While the woven fabric of the patent references is structurally acceptable, the woven fabrics thereof have the disadvantage of limited spreading ability with the result that the fold lines or bends in the prosthesis may not be avoidable.

Description of the Best Mode In complying with the requirements of the Patent Laws, the best mode currently known to applicants with respect to the characteristics of the fabric and the filling for the implant is described hereinbelow. It is understood that the materials are described by way of example and not by way of limitation, and that it is anticipated that other materials, known or subsequently created, would function properly in the environment of the prosthesis device. A preferred yarn for manufacturing the exterior 12 is a homopolymer polyester with minimal additives or contaminants. Suitable fillers are manufactured by Dupont Corporation and identified as DACRON TYPE 76T and by WELLMAN INC. Under the trademark FORTREL (TYPE 302). The fibers used in the formation of the interlaced shell 12 are preferably comprised of a 50 denier type 56 multifilament textured dacron, the yarn being comprised of 47 filament fibers that make up the bundle. The filaments that make up the yarn of the preferred example are 1.06 denier in filament diameter, with successful results anticipated with the fibers in the 0.4 to 3 denier scale. The interlacing is performed to provide a fabric that has a weight of 50,858 to 203,433 grams / m2, with an optimum of 84,764 grams / m2. The braiding of the interlaced within the weight scales annotated provides a liquid permeability of the resulting fabric from a minimum of approximately 50 cc / cm2 / min to a standard 120 mm mercury pressure for the less dense woven material up to approximately 10000 cc / cm2 / min for the minimum density material. A preferred permeability value for the fabric 12 is approximately 2000 cc / cm2 / min. The inner layers 14 'to 18' are preferably of high permeability, ie, greater than 2000 cc / cm2 / min. The inner layers 14 'to 18' are preferably, though not necessarily, woven. The use of stretchable or ductile outer fabric 12 in combination with the fabric and thus the more pronounced internal retaining dividers provide a unique structure that is capable of expanding and contracting with minimal distortion of the radial direction. The polyester polymer sides used for various fabrics can be texturized or non-textured, with texturing preferred as they increase tissue growth. With respect to the fiber used in filler chambers 14 to 19, the Well man 302 type is preferred. The denier of the fiber filaments can vary from anywhere between 0.4 to about 3.5 denier. A preferred value comprises fabric cut into lengths of approximately 3.81 cm with a weight of approximately 2.25 denier. The fiber lengths can vary from 1.27 cm to 10. 16 cm with the shorter fibers used in the cameras located earlier. With respect to the density of fi ber fillers, fiber density will increase in chambers located posteriorly to approximately 0.36 grams per cubic centimeter of polyester staple fiber. The fiber density in the most anterior chamber can be as small as 0.01 grams per cubic centimeter. The densities noted are calculated based on the fibrous materials of lengths of 3.81 cm and 2.25 denier. From the foregoing, it will be appreciated that a new and improved breast prosthesis is provided in accordance with the invention which is permanent and which, after implantation, in all respects closely resembles a human breast. When constructed from the fabric in some preferred extensible manner, due to the distension capability of the device and the improved growth of tissue and body fluids, a degree of volumetric distension and contraction of the prosthesis as well as limited contour variation is possible coordinate the size of the prosthesis with the gain or loss of weight of the patient. Compared to known prostheses in which the size of the device controls the shape of the body, in the current device the body controls the size of the prosthesis. It is important to note that each of the chambers defined by the internal partitions provide an environment for the growth of body tissue, the amount of tissue growth and fluid retention being controlled in accordance with the density of the fiber filler inside the chambers respective divisions. By providing the chambers that have different fiber densities in combination with a highly permeable retention structure, a prosthetic sinus implant is created for the first time that can be adapted to the specific requirements of the patient to allow the desired cosmetic and tactile final results. Since the interior of the prosthesis will ultimately be permeated with living tissue, the implant will be retained essentially at body temperature and the thermally induced discomfort inherent in the use of devices filled with liquid is eliminated. As will be apparent to those skilled in the art and familiar with the present disclosure, numerous variations may be made in the details of construction and selection of materials without departing from the spirit of the invention. Accordingly, the invention is to be considered broadly within the scope of the appended claims.

Claims (9)

1. A prosthetic implant comprising a biocompatible fabric shell permeable to tissue growth and body fluids in the general configuration of a cone, a plurality of permeable partitions extending transversely within the shell and dividing the shell into a series of cameras, and biocompatible fibrous masses placed inside said chambers.

2. A prosthesis according to claim 1, wherein the density of said fibrous masses progressively increases in the chambers furthest from the apex of the shell.

3. A prosthesis according to claim 1, wherein the shell includes an outer surface portion of corduroy.

4. A prosthesis according to claim 1, wherein the shell and the fibrous filler are comprised of a homopolymer polyester material.

A prosthesis according to claim 1, wherein the shell comprises a woven fabric that includes on the outer surface thereof warp ends that extend multiple fillers to define braids.

6. A prosthesis according to claim 1, wherein the partitions are comprised of open woven fabric.

7. A prosthesis according to claim 1, wherein the shell comprises a stretchable braided fabric so that it can increase and decrease in volume.

8. A prosthesis according to claim 7, wherein the partitions are made of woven fabric and are less extensible than the shell fabric, so that the prosthesis is susceptible to greater growth in the direction of the axis of the cone than in the radial direction.

9. A prosthesis according to claim 8, which includes at least two partitions that divide the interior of the prosthesis in at least three chambers, the concentration of the fibrous masses increasing progressively in the chambers furthest from the vertex of the prosthesis. shell.