MXPA99003345A - Method and apparatus for tissue enlargement - Google Patents

Abstract

An apparatus and method for enlargement of soft tissue, such as breast, including a vessel or dome configured to fit over the tissue which is to be enhanced or enlarged. The dome or vessel has a sealing cushion of elastic material which surrounds and encompasses the perimeter of the base of the vessel. The cushion includes a fluid compartment which is compressible. The fluid compartment is deformable such that when the vacuum is applied to the sphere, the seal material and compartment deform, isolate, and diffuse the pressure on the skin. The apparatus also includes a vacuum pump with a power source, a pressure sensor to regulate the pressure, or vacuum provided by the pump. The dome also includes a valve mechanism for controlling the ingress and egress of the vacuum to the interior of the dome. This valve will automatically close so that the pump may be removed from the dome and the pressure or vacuum therein be maintained. This valve also includes a release mechanism to remove or exhaust the vacuum in case of discomfort or emergency. The domes may also have different configurations, including rectangular, though normally they will remain as a sphere to maximize and equalize the augmentation of the flesh or tissue within the confines of the dome. The dome also is formed with a footed rim which is embedded in a deformable elastic cushion with a fluid pocket to augment the deformation and consequent reduction in the per square inch pressure applied to the tissue of the wearer.

Description

METHOD AND APPARATUS FOR TISSUE ENLARGEMENT BACKGROUND AND BRIEF DESCRIPTION OF THE INVENTION FIELD OF THE INVENTION AND RELATED TECHNIQUE Enlargement or enlargement of tissue and especially soft tissue on a person's body is often desirable, and may also be necessary to correct abnormalities or improve healing. The improvement or enlargement of breast tissues is an example of an enlargement of this type. A non-invasive and safe method of soft tissue augmentation, such as breast augmentation, is necessary. A safe method and / or apparatus is necessary, especially after recent problems with implants. There has long been an understanding of how enlarged soft tissue can occur naturally, for example, the expansion of the skin during pregnancy and other parts of the body that accommodate internal growth, including subcutaneous growths, as well as loss and / or weight gain. REF .: 29962 The devices and methods of the prior art, include surgical techniques, including the insertion of balloons and spikes for the lengthening of the limbs. A complete review of this prior art is described in U.S. Patent No. 5,536,233 as the basis for improvement described herein. The generalized method and apparatus described in U.S. Patent No. 5,536,233 is an improvement over the prior art and describes the basis for the improved invention described herein. The prior art has described that soft tissue augmentation must occur by means of vacuum. However, the prior art has not described the vacuum apparatus or valve that could provide controlled augmentation of tissue over various parts of the body. This invention produces a permanent increase in tissue, especially soft tissue, without damaging surgical or other defects on the patient. I The prior art describes the use of a vacuum to produce soft tissue augmentation. As noted in U.S. Patent No. 5,536,233, the prior art failed to achieve long-term soft tissue augmentation without damage to the soft tissue that is enlarged, as well as surrounding tissue. This damage to surrounding tissue has limited the amount of vacuum that can be applied to soft tissue for purposes of augmentation or lengthening. U.S. Patent No. 5,536,233 of the prior art has attempted to avoid this damage to surrounding tissue by the use of a flange around the periphery of the dome to which the vacuum is applied. This flange is described as having a sufficient surface area, so that the pressure applied by the flange is less than or equal to the negative pressure applied to the soft tissue under the dome. By regulating the pressure inside the dome to 381 mm (1"inches) of mercury (Hg), damage to soft tissue is avoided by using the flange.The prior art is limited to a vacuum with a magnitude less than 381 mm (1 - ^ inches) of Hg, which limits the increase.This invention overcomes that limitation, of limiting the pressure that can be used for cell augmentation by diffusion, by a novel seal, the excessive pressures that had previously been applied to the surrounding tissue, causing contusions and / or tissue damage.

The normal animal cell, including that of humans, has * in general a predefined shape and size. It has been discovered that when sufficient tension is applied, the cell will increase in size and its external structure will also be diverted to accommodate any vacuum or negative force that is applied to the cell. The proper application of vacuum to the cellular structure can induce the cell to replicate and / or accommodate the stress that is applied by the vacuum. The elasticity of the cell membranes and their support structure, as noted in the prior art and as discovered in the use of this invention, can be damaged beyond repair by applying an excessive amount of vacuum. Therefore, it is critical that the amount of vacuum be controlled and limited to avoid damage to the cells, including the internal mechanisms and membranes, which are subject to vacuum, as well as the cells in the surrounding tissue. This invention has shown that animal cell structures can accommodate vacuums of 22.86 μm (0.0009 inches) of Hg up to 381 mm (15 inches) of Hg without tissue destruction, if properly applied. Above 381 mm (15 inches) of Hg, massive destruction of healthy cells occurs. It has been shown that the total destruction of the cell membrane and the nucleus by stretching or increasing beyond its physical limits, will destroy these cells. The observation indicates that unhealthy cells that are less elastic will be destroyed at different pressures, so regeneration is not possible as with healthy cells. This can have positive health benefits due to the destruction of unhealthy cells and the increase of healthy cells. Unhealthy cells will be destroyed at any cost and care should be taken not to apply even small amounts of vacuum to unhealthy cells. In general, voids above 381 mm (15 inches) of Hg are needed to destroy most of the soft tissue cells. However, a rapid and dramatic rise in vacuum (decompression) of 0-203.2 mm (0-8 inches) of Hg can cause massive cell damage, as shown by bruises and contusions. The body system can routinely repair most, if not all, of the damage caused by light to medium amounts of vacuum. This is similar for the repair of minor contusions, discoloration and vascular infiltration caused by small amounts of vacuum, such as that which can be applied to the skin by the vacuum induced by the mouth. It has been found that the optimum pressure or optimum vacuum in inches or millimeters of Hg, necessary to produce the desired effect of induction of reproduction or cell enlargement and enlargement or augmentation of soft tissue is 254 mm (10 inches) of Hg. As a result of the experiments using this invention, it has been reported that each new generation of cell growth or enhancement improves the elasticity and firmness of cell membranes. Observations from the applicant's experiments indicate that the largest cell structure is subjected to tension by applying 25-75% of the maximum safe vacuum in millimeters (inches) of Hg over a prolonged period of time, the new cell growth is more Strong in structure and more elastic. It has also been shown from the experiments that the greater the vacuum or negative pressure of up to 254 mm (10 inches) of Hg, applied, the more firm the increased tissue will result in a shorter time.

If this method and apparatus is used, for example, a vacuum of 25.5 - 228.-6 mm (1-9 inches) of Hg, contusions or small and superficial bruises will occur at the start of the augmentation process. It has been determined that the comfort level of the vacuum should be gradually increased over a period of time, starting from approximately 25.8 - 38.1 mm (1-1 - inches) of Hg and proceg to higher vacuum values up to 216 to 268.6 mm ( 8.5 to 9 inches) maximum. The apparatus from which the tests were conducted could create a vacuum of 254 mm (10 inches) of Hg. This maximum amount is reduced by 254 mm (10 inches) of Hg for safety purposes. This invention has also been used with variation in the configuration of the dome, the sphere, or the shape of a vacuum applicator and / or the containment container. The variation of the shape of the vacuum applicator varies the forces exerted on the material or tissue enclosed in the sphere. In this way, the fabric can be lengthened, enlarged or made wider by increasing or expanding within the sphere. It has also been discovered in the use of the invention, that the more tissue there is under and in proximity to the dome, the suction force and the enlargement ratio increase. Thus, this invention provides a plurality of containers or domes with various configurations for controlling the direction and the rate of cell augmentation or enlargement. The vacuum force acts to cause the veins and arteries to become congested carrying with them the benefits of increased blood flow which is a beneficial side effect provided by this invention in conjunction with the enlargement. Although this invention has not been used, except to produce new and enlarged or enlarged soft tissue structures, it is believed that other uses of vacuum pressure to induce cell growth could be useful in other areas. This could require the development of new containers or instruments that could enclose the area or tissues that are going to be repaired, while not damaging the surrounding tissue. The increase in the flow Blood, due to enlargement in the blood vessels, could improve cells and provide more nutrients to damaged areas such as burns. It can also be useful in muscle development and bone tissue development in environments with zero gravity (0) or it may seem useful in most of any tissue that has morphotic characteristics. As noted above, the prior art devices have failed to achieve long-term soft tissue enlargement, while preventing damage to the soft tissue that is enlarged, as well as any surrounding tissue. These prior art devices have not been successful due to the amount of vacuum necessary to produce the successful enlargement of the soft tissue, which could not be achieved without damaging the surrounding tissue. The low vacuum pressure described in the prior art does not provide adequate enlargement or enlargement of the soft tissue, because the amount of pressure was limited by the ability of the device to prevent damage to the surrounding tissue. This invention allows the use of a method for enclosing the soft tissue within a containment device, by applying a substantial vacuum to the soft tissue. The downward force of the vacuum is absorbed by the new seal without damaging the surrounding tissue, against which the container reacts. The invention is capable of using a vacuum pressure that will enlarge soft tissue at higher pressures than prior art devices. The novel seal and force diffuser between the vacuum vessel and the human cells or tissues that surround the tissues that are to be augmented, allows the use of a vacuum force that will stimulate cellular activity without permanent damage to the cells and / or to user.

DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic view of the invention.

Figure 2 is a view of a container, including the breast.

Figure 3 is a view of a container with the vacuum applied.

Figure 4 is a form of the container.

Figure 5 is another embodiment of the container.

Figure 6 is a sectional view of Figure 4 without a vacuum.

Figure 7 is a sectional view of Figure 3 with applied vacuum.

Figure 8 is an exploded view of the check valve.

Figure 9 is a check valve in the evacuation mode.

Figure 10 is a check valve in the relief or release mode.

DETAILED DESCRIPTION OF THE INVENTION The tissue augmentation apparatus of this invention, which provides the augmentation method, is shown in Figure 1. This device or apparatus includes a containment vessel or containers also referred to as domes or biospheres 30. The biospheres 30 have an inlet or outlet 40 which has a novel valve assembly 50 inserted in the inlet or outlet. The sphere 30 also has a sealing pad 60 that surrounds the base of the sphere 30. The sphere 30 is designed to encompass the body portions that are to be enlarged or enlarged. Relief valve 70 and check valve 51 are incorporated in the valve assembly 50 to allow positive vacuum release or at any time deemed necessary. A vacuum source, shown as the pump 80, is connected via the line 90 to the spheres 30 and to the valve assembly 50. A power supply 100 is connected to the control valve 80 through the manual control unit 110. The optional external control valve is shown as 80A. Containers or containment spheres 30 are made of a material, preferably a plastic, which is hypo-allergenic and resistant to implosion and other destructive forces. The spheres 30, as used, were made of high impact plastic polymers. The self-sealing valve 50 inserted in the inlet or outlet 40 is designed to retain any vacuum created in the sphere. A relief valve 70 and check valve 51 are included as part of the novel valve mechanism 50 of this invention. As shown in Figure 8, the valve 50 includes the vacuum inlet 61, which is also the exhaust port 71, which releases the vacuum when the relief valve 70 is actuated. The check valve 51 and the relief valve 70 comprise a unit, although the valves could be designed to be operated separately. The check valve 51 maintains the vacuum by operation of the housing 62, the valve body, the intermediate cover 63 of the valve body, the packing 64 of the check valve, the cover 65 of the valve body, the retainer tang 66 of the package, and the retainer holes 62 of the package. The vacuum is applied to the valve via the pipe 90 from the vacuum source 80. The relief valve portion 70 comprises the relief valve tension spring 71, the seal 72, the piston 73, the exhaust gate 74, and body 75 of the relief valve. As shown in Figures 6 and 7, the cushion 60 is designed to provide an airtight seal between the sphere 30 and the body of the person wearing the sphere 30. The cushion 60 is flexible and waterproof, and it includes an integral air cushion 61. The cushion or seal 60 must be made of flexible material which is elastic and has some compressible characteristics. This air cushion 61 could also be a different fluid of air, but one that must be compressible. The air cushion 61 in its uncompressed state is one of oval shape, normally in line, with the surface 31 of the sphere. In this novel mechanism, the surface 31 of the sphere is divided into two bevels or flanges 32 and 33 in order to more evenly distribute the forces applied by the vacuum to the sphere 30. When the seal 60 is compressed, the air cushion 61 is deformed to increase the surface area below the sphere 30. This will serve to diffuse and reduce the pressure on the surface, at a level that does not cause bruises, for example, when no more than 254 are applied. mm (10 inches). 1 • . The operation of this device and the method of cell augmentation or enlargement will now be described. The operation of this device will be described with special relation to the enlargement of average women who have normal healthy breasts. As has been noted, the design of the containment container or the container to which the vacuum is to be applied is of the utmost importance. The container must be designed to encompass and direct enlargement or augmentation by vacuum. The shape of the container and the size of the container must be coordinated with the mass and shape of the tissue that is to be enlarged. It has been determined that there are several forms and designs that could be used to improve breast enlargement. The requirement and the importance of the shape of the container is that this form controls the distribution of forces and the direction of the forces by designing the container. This has been determined from an analysis of the current size of brassieres, including the shape of the cup, from 30A to 50DDD. Since such a size adjustment is critical for conformation and proper and proportional development, it is necessary for the person to take certain measures in order to determine the shape and size of the container to adequately augment the bust. The first critical measurement is the width of the bust where the outermost part of the bust is connected to the chest wall. The next most critical measurement is the size of the cup in inches for the North American market and the metric system for foreign markets. This is done by measuring the widest part of the breast appendix. Another critical measurement is the length of the bust from the ribs to the teat. Then these critical measurements can be used to determine the biosphere or optimum vessel for the breast for each adequate individual breast augmentation. As the breast or soft tissue is permanently enlarged, it may not be necessary only but it will be necessary to change the size or design of the container. There are three basic designs for the operation of this device. The diameter and height of the container or sphere will be changed according to individual needs. The basic design for the smaller breasts will normally have a diameter of the range of 7.62 cm to 22.86 cm (3 to 9 inches) and the height of the container may be in the range of 5.08 to 25.4 cm (2 to 10 inches). The following basic design could be used for people who have a current support size of 32AAA up to 50A, and, in this case, the diameter of the container will be in the range of 7.62 to 30.48 cm (3 to 12 inches) and the height of container will be in the range of 5.08 to 25.4 cm (2 to 10 inches). The third basic design could be used by people who have a current support size of 32C / D to 50D / DD. In this case, the diameter of the container will be in the range of 7.62 to 30.48 cm (3 to 12 inches), and the height in the range of 5.08 to 25.4 cm (2 to 10 inches). As the breast is enlarged and changed in shape by the use of this device, it will become necessary to redefine and re-measure breast size. This will require a change in the size and shape of the sphere or container to continue the enlargement or enlargement of the soft tissue to the desired shape. The contact area under the cushion 60 and also the lubrication of at least 5.08 cm (2 inches) outside the seal point with the skin. This is to ensure that the skin is able to move in response to the vacuum, without damaging the soft tissue, and still maintain the seal. It will also be necessary to moisten the areola and other breast tissues at the same time to increase expansion and to facilitate free movement. The person then places the container or biosphere on each breast. The vacuum pipe 90 could be connected to the valve 50. The other end of the pipe could be connected to the vacuum pump 90 through the control unit 80 or 80A. The vacuum control unit is plugged into a direct current power supply 100 which is connected to an alternating current power source. The 80 or 80A control unit has for example, a plurality of adjustment devices for vacuum pressure. These settings can be low, medium, high and maximum to allow the user to adjust the amount of vacuum to a calibration that is more comfortable and / or to maximize the augmentation process. These settings start at low and go to the maximum allowed by control unit 50 or 50A. The pump is then turned on and the setting that is most comfortable for the individual is chosen and applied to the resulting vacuum to the biosphere. Once. the level of vacuum has been reached, which can be called a comfort level, for example, the person feels comfortable with the amount of vacuum that is applied to the breasts, the tubing is removed from the container and the integral check valve 51 keeps that pressure. The user can then move freely. The user can put a brassiere or bra on the spheres or the spheres are self-supporting and the user is free to move where they want, go to bed or any other operations they want. The time of use of this active process is critical. The more vacuum time, the faster results are obtained. The excessive use of the process can cause formation of ampules and theft of the contact skin with the normal atmosphere for oxygen and evaporation of body fluids. Through testing it has been found that the process can be used as described below, but can , also be designed for the personal needs and lifestyles of individuals. The more sensitive the skin of individuals and the speed at which each individual body heals, will have a direct effect on the healthy use of this process. The recommended process is to start at the lowest level of vacuum and slowly reach the highest level and use the vacuum for 6 to 8 hours every third day. This allows time for the cells to rejuvenate and recover from the process. This should be done every third day for 8 days and then let the soft tissue rest for 3 days. Then the process begins again with the same routine. Some-individuals may use higher settings, sooner than other individuals. These recommendations have been achieved through experimentation for the average healthy person. Variations can and will take place. Permanent side effects have not been observed during the test. This process penetrates deep into the layers of the soft tissue and will also help to firm and augment the underlying muscle tissue. When the maximum application time is reached and if the user becomes uncomfortable and the user wishes to remove the containers, all that is needed is to press the release valve and this will automatically release the vacuum in the container. 1 If you want to use the containers during a routine during sleep, there is an optional cover that can be placed over the release valve to prevent accidental discharge.

Having described the preferred embodiment, other features of the present invention will undoubtedly occur to those skilled in the art, as will numerous modifications and alterations in the illustrated embodiments of the invention, all of which can be achieved without departing from the spirit and scope of the invention. the invention as defined in the appended claims.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (38)

CLAIMS Having described the invention as above, the content of the following claims is claimed as property:

1. An apparatus for augmenting living tissue, characterized in that it comprises: a) a container that encompasses the tissue to be enlarged; b) a vacuum source connected to the container; and c) a flexible mass attached to the open end of the container, to absorb the pressure exerted by the vacuum, thereby acting as a seal and force to the diffuser between the container and the tissue adjacent to the periphery of said container.

2. The apparatus according to claim 1, characterized in that the container has a shape that conforms generally to the shape of the tissue to be enlarged.

3. The apparatus according to claim 1, characterized in that the container has a volume greater than the volume of the tissue to be increased.

4. The apparatus according to claim 1, characterized in that the container has a shape that is varied to control the shape of the enlarged tissue.

5. The apparatus according to claim 1, characterized in that the container is dome-shaped and open at one end to enclose the tissue to be enlarged.

6. The apparatus according to claim 1, characterized in that the container has an opening separated from the open end for connection to a vacuum source.

7. The apparatus according to claim 1, characterized in that the flexible material surrounds an air pocket.

8. The apparatus according to claim 7, characterized in that the air bag is substantially circular and aligned with the center line of the periphery of the container.

9. The compliance apparatus "with claim 8, characterized in that the periphery of the open end of the container includes flanges at angles to the center line of said periphery.

10. The apparatus according to claim 9, characterized in that the flanges have an arched configuration.

11. The apparatus according to claim 10, characterized in that the arcuate configuration is convex with respect to the periphery of the container.

12. The apparatus according to claim 9, characterized in that the flange applies the vacuum force to the flexible mass and to the air pocket, to substantially diffuse the vacuum force applied to the base of the flexible material fixed to the container.

13. The apparatus according to claim 1, characterized in that the connection between the vacuum source and the container includes a pump mechanism.

14. The apparatus according to claim 13, characterized in that the valve mechanism includes a check valve.

15. The apparatus according to claim 13, characterized in that the valve mechanism includes a relief valve.

16. The apparatus according to claim 13, characterized in that the valve mechanism includes a check valve and a relief valve to automatically maintain the vacuum in the container and provide instantaneous release of the vacuum.

17. The apparatus according to claim 1, characterized in that the container will withstand a vacuum of 381 mm (15 inches) of Hg.

18. The apparatus according to claim 1, characterized in that the vacuum source includes a control mechanism for controlling the vacuum valve provided.

19. The apparatus according to claim 18, characterized in that the control mechanisms will control the vacuum from 254 mm (0.1 inches) of Hg to a maximum of 254 mm (10 inches) of Hg to be applied to the container.

20. An apparatus for enlarging living tissue, characterized in that it comprises: a) a container that encompasses the tissue to be enlarged; b) a vacuum source connected to the container; and c) a mass of elastic material fixed to the perimeter of the open end of the container, to transform the applied vacuum, to create a seal between the interior of the container and the material on which the container rests.

21. The apparatus according to claim 20, characterized in that the container has a shape that conforms generally to the shape of the tissue to be enlarged.

22. The apparatus according to claim 20, characterized in that the container has an interior volume greater than the volume of the tissue to be enlarged.

23. The apparatus according to claim 20, characterized in that the container has a shape that is varied to control the configuration of the resulting enlargement.

24. The apparatus according to claim 20, characterized in that the container is dome-shaped and open at one end to circularly surround the tissue to be enlarged.

25. The apparatus according to claim 20, characterized in that the container has an opening separated from the open end for connection to a vacuum source.

26. The apparatus according to claim 20, characterized in that the elastic material surrounds an air pocket.

27. The apparatus according to claim 26, characterized in that the air bag is substantially circular and aligned with the center line of the perimeter of the container.

28. The apparatus according to claim 27, characterized in that the perimeter of the open end of the container includes tabs at angles to the center line of said perimeter.

29. The apparatus according to claim 28, characterized in that the flanges have an arched configuration.

30. The apparatus according to claim 29, characterized in that the arched configuration is convex with respect to the perimeter of the container.

31. The apparatus according to claim 28, characterized in that the flanges apply the force of the vacuum to the elastic material and to the air bag, to diffuse substantially the force of the vacuum applied to the base of the elastic material.

32. The apparatus according to claim 20, characterized in that the connection between the vacuum source and the container includes a valve mechanism.

33. The apparatus according to claim 32, characterized in that the valve mechanism includes a check valve.

34. The apparatus according to claim 32, characterized in that the valve mechanism includes a relief valve.

35. The apparatus according to claim 24, characterized in that the valve mechanism includes a check valve and a relief valve to automatically maintain the vacuum in the container and provide instantaneous release of the vacuum.

36. The apparatus according to claim 20, characterized in that the container will withstand a vacuum of 381 mm (15 inches) of mercury.

37. The apparatus according to claim 20, characterized in that the vacuum source includes a control mechanism for controlling the value of the vacuum provided.

38. The apparatus according to claim 37, characterized in that the control mechanisms will limit the vacuum from 25.4 mm (1 inch) of Hg to a maximum of 254 mm (10 inches) of Hg to be applied to said container. SUMMARY OF THE INVENTION An apparatus and method for enlarging soft tissue, such as the breast, is described, including a container or dome configured to fit over the tissue which is to be enlarged or enlarged. The dome or container has a sealing cushion of elastic material that surrounds and covers the perimeter of the base of the container. The cushion includes a fluid compartment that is compressible. The fluid compartment is deformable such that, when the vacuum is applied to the sphere, the sealing material and the compartment deform, the pressure on the skin is isolated and diffused. The apparatus also includes a vacuum pump with a power source, a pressure sensor for regulating the pressure, or a vacuum provided by the pump. The dome also includes a valve mechanism to control the entry and exit of the vacuum into the interior of the dome. This valve will close automatically so that the pump can be removed from the dome and the pressure or vacuum in it will be maintained. This valve also includes a release mechanism to remove or release the vacuum in case of discomfort or emergency. The domes can also have different configurations, including rectangular, although normally these will remain as a sphere to maximize and equalize the increase of flesh or tissue within the confines of the dome. The dome is also formed with a base flange, which is embedded in a deformable elastic cushion with a fluid bag, to increase the deformation and consequent reduction in pressure applied per square centimeter (or per square inch) to the tissue of the user.