WO2009023766A1

WO2009023766A1 - In vivo transportation of silicone gel for use in breast reconstruction and augmentation

Info

Publication number: WO2009023766A1
Application number: PCT/US2008/073132
Authority: WO
Inventors: Jr. Walter Presz; Stanley Kowalski Iii; Bart Lipkens; Matthew Haley
Original assignee: Flodesign, Inc.
Priority date: 2007-08-15
Filing date: 2008-08-14
Publication date: 2009-02-19

Abstract

An evacuated breast implant shell is surgically implanted into the body. One end of a fill tube is attached to a valve on the shell, while the other end of the fill tube is attached to an output port of a pump. The pump includes a container that seals around a pre-filled silicone breast implant containing an amount of silicone gel to be transported to the shell in the body. A rubber diaphragm is located on a lower surface of a pressure chamber. An input port on the top portion of the pressure chamber connects to a source of compressed air. The rubber diaphragm is expanded by the compressed air flowing into the pressure chamber, which causes the diaphragm to press on the implant in the container and forces trie silicone gel in the implant to flow out of the implant and into the implant.

Description

IN VIVO TRANSPORTATION OF SILICONE GEL FOR USE IN BREAST RECONSTRUCTION AND AUGMENTATION

PRIORITY INFORMATION

This patent application claims priority from U.S. patent application serial number 60/955,909 filed August 15, 2007, which is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

This invention relates in general to the field of breast augmentation and reconstruction using fluid-filled implants, and in particular to a fluid transportation system that fills a breast implant with an accurate amount of a viscous fluid such as a silicone gel.

The search for more realistic materials and less invasive surgery techniques for breast augmentation and reconstruction has existed since the late 1800's and continues today. Several materials and designs have failed since that time, but two main implant types have remained - those filled with a saline solution and those filled with a silicone gel. Silicone implants had met an early demise when studies showed that silicone poisoning resulted in some cases when the implant ruptured. With the re-approval of silicone by the FDA, silicone implants are once again a competitor in the field of breast implants. An implant filled with silicone gel tends to be more desirable as compared to an implant filled with saline solution because the silicone gel provides a more realistic feel and appearance, and is therefore widely desired and used for augmentation and reconstruction purposes. The silicone gel has many properties that mimic that of a solid material and the inherent gel qualities of the silicone significantly reduces the possibility of silicone leakage if an implant ruptures.

Current manufacturing practices require the gel to be pre-filled into the silicone implant shell prior to surgical implantation. To then safely insert a filled silicone implant into a human body, a much larger incision is required as compared to that for a saline implant. This leaves a much larger scar than is typically desired. The growing demand for silicone implants and at the same time for smaller incisions has led to the practice of unsafe surgical techniques around the world where surgeons performing transaxial incisions deform the silicone implant, oftentimes to extreme conditions, to attempt to insert them through the smaller incisions. While such deformations may cause ruptures or stresses to the shell, there is little or no information provided to the surgeon on what kind of damage this deformation actually causes to the silicone shell during the surgical implant procedure. The current manufacturing process for filling the implant requires that the silicone be inserted into the shell in the uncured state. The uncured silicone has a lower viscosity, typically around 520 cP (Ceintipoise). The cure procedure requires heat and time. Typical time is lhour to 3 days and the heat required ranges from 100-200 Deg C. The cured viscosity is usually a trade secret for the implant manufacturers and viscosity can range from 1250-10OK cP (Ceintipoise).

Previous attempts have been made at moving the cured silicone gel through relatively small orifices, but the gel experienced shear forces and broke down into a cottage-cheese like material.

On the other hand, saline implants allow for a relatively smaller incision to be made due to the fact that an evacuated shell of the implant is inserted into the tissue rather than a filled implant. Saline solution is then introduced into the empty implant via an external source that is connected typically to a self-sealing valve on the surface of the implant. Specifically, a saline implant is received by the surgeon evacuated of all air. Typically a 2 centimeter incision is made on the patient in one of several possible locations. This size of incision is relatively smaller than that required for a silicone filled implant. Thus, the resulting scar is smaller. The implant shell is then rolled into a taco- like shape for insertion through the opening. This process does not usually harm the implant as the outer shell of the saline implant is typically made of a flexible silicone material. A connecting tube is attached to the diaphragm valve that is part of the implant shell, where the valve self seals when the tube is disconnected thereby retaining a smooth surface of the implant to avoid any chafing. The other, loose end of the tube is connected to a syringe and two-way check valve to allow all air to be suctioned out of the tube. Some air is generally allowable as it will diffuse through the silicone shell. Next the saline filled syringe is attached to the loose end of the tube, and the saline solution is injected through the tube and into the implant. Depending on the volume capacity of the implant, it may take multiple syringe loads to fill the implant to the desired level with saline solution. Thus, it is important for the surgeon to keep track of how much saline fluid is actually being injected into the implant shell. Oftentimes, this can be a problem if the surgeon gets distracted for some reason or if the syringe or any other part of the fluid delivery system malfunctions. When the implant is eventually filled to the appropriate level, the tube can be removed and the surgery finished. In some cases the tube can remain subdermal with another form of a self-sealing valve for post-operation size corrections by the patient. However, another problem with these saline implants is that the saline solution makes the resulting implant feel stiffer and less life-like as compared to a silicone implant.

What is needed is a safe and marketable procedure and apparatus for surgically inserting and accurately filling a silicone breast implant with silicone gel in- vivo.

SUMMARY OF THE INVENTION

Briefly, according to an aspect of the present invention, an evacuated silicone breast implant shell is surgically implanted into the human body through a relatively small incision. One end of a fill tube is attached to a diaphragm valve located on the implant shell. The other end of the fill tube is attached to an output port of a pump. The pump includes a form fitting two-part implant container that defines a cavity. When closed, the container seals around a pre-filled silicone breast implant inserted into the cavity and containing the desired amount of silicone gel to be transported to the evacuated silicone implant shell surgically implanted into the body. An upper portion of the container includes a pressure chamber. A rubber diaphragm is located on a lower surface of the pressure chamber. An input port on the top portion of the pressure chamber connects to a source of compressed air to provide air under pressure to the pressure chamber.

In operation, the rubber diaphragm is expanded by the compressed air flowing into the pressure chamber, which causes the diaphragm to press on the implant in the cavity of the container. This force provided by the diaphragm on the implant in the container causes the silicone gel in the implant to flow out of an opening in the implant and into and through the tubing connected to the valve on the surgically implanted implant and into the implant. The pump allows for a relatively even pressure distribution across the implant in the cavity of the container to insure a smooth and accurate transfer of the silicone gel into the surgically implanted implant in the body. The apparatus also provides for the transfer of cured silicone through small orifices. This major accomplishment allows for in- vivo silicone breast implant fill. Additionally, since the apparatus uses the existing cured silicone breast implant manufacturing processes for the supply, it greatly alleviates the FDA requirements. Furthermore, surgeons are more likely to adopt this procedure since it combines the advantages of saline with silicone.

These and other objects, features and advantages of the present invention will become more apparent in light of the following detailed description of preferred embodiments thereof, as illustrated in the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a shell of a silicone implant folded in preparation for surgical implantation into the human body;

FIG. 2 is a perspective view of the implant shell of FIG. 1 surgically implanted into the body and filled at least partially with silicone gel;

FIG. 3 is a perspective view, partially cutaway, of a pump according to the present invention for providing silicone gel to the implant;

FIG. 4 is a perspective view, partially in cross-section, of the pump of FIG. 3 attached to a source of compressed air; and

FIG. 5, including FIGs. 5a and 5b, are side views of the diaphragm valve located in the implant of FIG.l . DETAILED DESCRIPTION OF THE INVENTION

In the figures, like reference numerals refer to like elements. Referring to FIG. 1, an empty or evacuated shell 10 of a breast implant 12 is illustrated as being folded over in preparation for surgical implantation into the human body. The shell 10 is typically made from a flexible silicone material and is intended to contain an amount of silicone gel provided to the evacuated shell by the pump of the present invention after the shell is implanted into the body. Because the shell 10 is implanted into the body in an empty or evacuated state, a relatively small incision (e.g., 2 centimeters) is required, which is similar to the size of an incision for a saline implant which is also typically implanted into the body in an evacuated state.

Referring to FIG. 2, the implant 10 is illustrated after it has been surgically implanted into breast tissue 14 of the body and at least partially filled with silicone gel by the pump of the present invention. Emanating from the implant 12 is a portion of tubing 16 which leads to the pump of the present invention, as described in detail hereinafter. The silicone gel is provided to the implant 12 in vivo by the pump through the tubing 16.

Referring to FIGs. 3 and 4, there illustrated is a preferred exemplary embodiment of a pump 18 of the present invention. The pump 18 includes a form fitting two-part implant container comprised of upper and lower portions 20, 22 made of plastic or other suitable material. The upper and lower portions 20, 22 may be connected together by various means, such as hinges or clamps. Inside of the container is formed a cavity 24 that, when the container is closed, seals around a pre- filled silicone breast implant 26 of a typical size that contains the desired amount of silicone gel to be accurately transported to the evacuated silicone implant shell 10 surgically implanted into the body. The upper portion 20 of the container includes a pressure chamber 28 formed therein. A diaphragm 30 made of rubber or other suitable flexible material is located at a lower position of the pressure chamber 28. An input port 32 located on a top portion of the pressure chamber 28 connects to a source of compressed air 34 to provide air under pressure to the pressure chamber 28 to move the diaphragm 30 down against the implant 26.

In operation, the filled implant 26 is loaded into the cavity 24 of the container and the upper and lower portions 20, 22 of the container are locked together tightly. The rubber diaphragm 30 is expanded by the compressed air flowing from the source 34 into the pressure chamber 28. This air pressure causes the diaphragm 30 to press on the implant 26 in the cavity 24 of the container. The force provided by the diaphragm 30 on the implant 26 in the container causes the silicone gel in the implant 26 to flow out of an opening in the implant and out of an output port 36 of the container into and through the tubing 16 connected to the diaphragm valve (FIG. 5) on the surgically implanted implant 12 and into the implant shell 10. Cohesiveness of the silicone gel is unaltered by the equal-pressure force on the top half the implant 26 by the diaphragm 30. The pump 10 allows for a relatively even pressure distribution across the implant 26 in the container to insure a smooth and accurate transfer of the proper amount of silicone gel into the surgically implanted implant 12 in the body. Thus, the stretchable rubber diaphragm 30 mimics the plunger in a syringe when transporting the silicone gel through the output tube 16.

Prior to transporting the silicone gel from the implant 26 in the container to the surgically implanted implant 12, the pressure chamber 28 can be used to evacuate any air from the coaxial output tube 16 and the implant 12. In the alternative, a syringe and two- way check valve may be used to evacuate the air. Once all air is removed, air pressure can be raised in the pressure chamber 28 to expand the diaphragm 30 causing the silicone gel to flow from the implant 26 through the output tube 16 in a controlled and uniform manner. The entire pump 18 can be disposable, and will interface with any air compressor that can achieve the required pressure.

Referring to FIGs. 5a and 5b, a diaphragm valve 40 is illustrated as an integral part of the implant 12. The valve 40 in FIG. 5a is shown in relation to the implant shell 10 and connected with the fill tubing 16 attached to the pump 18 of the present invention during filling of the implant 12 with silicone. The valve 40 includes a plug 42, a stylet 44, and a tubing flange 46, which are readily accessible when filling the implant 12. These components ensure that the silicone is properly loaded into the implant shell 10 surgically implanted into the body. FIG. 5b shows the valve 40 after filling of the implant shell 10 is complete and the tubing 16 has been removed and the valve components 42-46 have been seated. The valve 40 has now self-sealed. What remains is the valve seat 48, along with the valve plug 50 which is flush with the surface of the implant shell 10. This avoids any chafing.

In some cases, a portion of the tubing 16 can remain subdermal with another form of a self-sealing valve for post-operation size corrections by the patient.

The present invention is advantageous in that it presents an alternative to current silicone implantation surgeries by providing a method and apparatus for transporting the gel to a surgically implanted evacuated implant during filling and post-operative correction procedures. The gel will survive intact unlike previous attempts at surgically implanting a pre-filled silicone gel implant. Thus, no longer will filled silicone shells need to be forcefully inserted through small incisions. This eliminates any possible damage done to the implant shell during insertion that otherwise may cause rupture or unknown damages to the shell. Further, the possibility for post-operative corrections will allow for the patient to be the quality control on her own body. This takes the responsibility away from the surgeon to deteπnine if alignment and size are what the patient expected, which is what is done today with some saline implants.

Also, no longer will different procedures need to be taught in order to adapt to the two types of implant material - silicone and saline. A uniform process of inserting the shell can be performed regardless of the implant fill material. That is, the pump of the present invention works equally well with a saline implant. All changes in surgery are contained within the pumping device used to inject the material in the implant shell. Further, the pump of the present invention requires no excessive force by the surgeon to transport the gel inside of the implant. Unlike with saline implants, a syringe is not used to inject the silicone gel. This eliminates the aforementioned problems with use of a syringe to fill an implant.

In addition, the pump allows for a less invasive surgery by allowing a similar size incision currently used with saline implants to be used with the silicone implant. This produces smaller scars and removes one of the major advantages of saline implants over silicone implants. The present invention uses FDA approved medical products in combination with a pump to transport silicone gel into the implant. Also, compatibility exists with tubing, shells, and diaphragm valves used with current saline and silicone implants. Although the present invention has been illustrated and described with respect to several preferred embodiments thereof, various changes, omissions and additions to the form and detail thereof, may be made therein, without departing from the spirit and scope of the invention.

What is claimed is:

Claims

1. Apparatus for transporting a fluid to a surgically implanted device, comprising: a pump having a container defining a cavity and a pressure chamber, where a diaphragm is located within the pressure chamber; and a tube connected with the cavity through which the fluid flows to the surgically implanted device; where when a sample containing fluid is located within the cavity and when a source of compressed air is connected with the pressure chamber to provide compressed air to the pressure chamber and onto the diaphragm, the diaphragm exerts pressure onto the sample containing fluid to force the fluid out through the tube and into the surgically implanted device.

2. The apparatus of claim 1, where the surgically implanted device comprises a breast implant.

3. The apparatus of claim 1, where the sample containing fluid comprises a breast implant filled with the fluid.

4. The apparatus of claim 1, where the fluid comprises a silicone gel.

5. The apparatus of claim 1, where the fluid comprises a saline solution.

6. The apparatus of claim 1, where the diaphragm comprises a flexible material.

7. The apparatus of claim 1 , where the diaphragm comprises rubber.

8. The apparatus of claim 1, where the container comprises two connecting pieces.

9. A method for transporting a fluid to a surgically implanted device, the method comprising the steps of: connecting one end of a tube to the surgically implanted device; connecting the other end of a tube to a pump; placing a pre-filled sample containing fluid within a cavity within the pump; connecting a source of compressed air to a pressure chamber within the pump; and causing compressed air to flow to a diaphragm located within the pressure chamber within the pump, where when the compressed air impinges on the diaphragm the diaphragm exerts a pressure on the pre-filled sample thereby causing the fluid in the sample to flow through the tube to the surgically implanted device.

10. The method of claim 9, further comprising the step of evacuating any air in the tube, the cavity and the pressure chamber prior to the step of placing a pre-filled sample.

11. The method of claim 9, where the fluid comprises a silicone gel.

12. The method of claim 9, where the fluid comprises a saline solution.

13. A method for surgically implanting a breast implant filled with a fluid in a human body, the method comprising the steps of: surgically implanting an evacuated breast implant shell in the human body; connecting one end of a tube to the surgically implanted breast implant shell; connecting the other end of the tube to a pump; placing a pre-filled breast implant sample containing the fluid within a cavity within the pump; connecting a source of compressed air to a pressure chamber within the pump; and causing compressed air to flow to a diaphragm located within the pressure chamber within the pump, where when the compressed air impinges on the diaphragm the diaphragm exerts a pressure on the pre-filled sample thereby causing the fluid in the sample to flow through the tube to the surgically implanted evacuated breast implant shell to thereby fill the shell.

14. The method of claim 13, further comprising the step of evacuating any air in the tube, the cavity and the pressure chamber prior to the step of placing a pre-filled breast implant sample.

15. The method of claim 13, where the fluid comprises a silicone gel.

16. The method of claim 13, where the fluid comprises a saline solution.