WO2009023766A1 - Transport in vivo de gel de silicone à utiliser dans la reconstruction et l'augmentation des seins - Google Patents

Transport in vivo de gel de silicone à utiliser dans la reconstruction et l'augmentation des seins Download PDF

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Publication number
WO2009023766A1
WO2009023766A1 PCT/US2008/073132 US2008073132W WO2009023766A1 WO 2009023766 A1 WO2009023766 A1 WO 2009023766A1 US 2008073132 W US2008073132 W US 2008073132W WO 2009023766 A1 WO2009023766 A1 WO 2009023766A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
fluid
diaphragm
pressure chamber
pump
Prior art date
Application number
PCT/US2008/073132
Other languages
English (en)
Inventor
Jr. Walter Presz
Stanley Kowalski Iii
Bart Lipkens
Matthew Haley
Original Assignee
Flodesign, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Flodesign, Inc. filed Critical Flodesign, Inc.
Publication of WO2009023766A1 publication Critical patent/WO2009023766A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/14586—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm
    • A61M5/14593—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm the diaphragm being actuated by fluid pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue

Definitions

  • 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 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).
  • 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.
  • a saline implant is received by the surgeon evacuated of all air.
  • 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.
  • 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.
  • 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.
  • the implant may take multiple syringe loads to fill the implant to the desired level with saline solution.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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;
  • FIG. 5 including FIGs. 5a and 5b, are side views of the diaphragm valve located in the implant of FIG.l .
  • 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.
  • 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.
  • 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.
  • 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.
  • the stretchable rubber diaphragm 30 mimics the plunger in a syringe when transporting the silicone gel through the output tube 16.
  • the pressure chamber 28 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.
  • 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.
  • 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.
  • 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 dete ⁇ nine if alignment and size are what the patient expected, which is what is done today with some saline implants.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une coque d'implant de sein évacuée qui est implantée chirurgicalement dans le corps. Une extrémité d'un tube de remplissage est attachée à une soupape sur la coque, alors que l'autre extrémité du tube de remplissage est attachée à un orifice de sortie de pompe. La pompe comprend un contenant qui scelle une zone autour d'un implant de sein en silicone pré-rempli comprenant une quantité de gel de silicone à transporter vers la coque dans le corps. Un diaphragme en caoutchouc est situé sur une surface inférieure d'une chambre de pression. Un orifice d'entrée sur la portion supérieure de la chambre de pression se raccorde à une source d'air comprimé. Le diaphragme en caoutchouc est dilaté par l'air comprimé circulant dans la chambre de pression, qui amène le diaphragme à presser sur l'implant dans le contenant et force le gel de silicone dans l'implant à sortir de l'implant et à aller dans l'implant.
PCT/US2008/073132 2007-08-15 2008-08-14 Transport in vivo de gel de silicone à utiliser dans la reconstruction et l'augmentation des seins WO2009023766A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US95590907P 2007-08-15 2007-08-15
US60/955,909 2007-08-15

Publications (1)

Publication Number Publication Date
WO2009023766A1 true WO2009023766A1 (fr) 2009-02-19

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/073132 WO2009023766A1 (fr) 2007-08-15 2008-08-14 Transport in vivo de gel de silicone à utiliser dans la reconstruction et l'augmentation des seins

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019155326A1 (fr) * 2018-02-09 2019-08-15 Ethicon, Inc. Expanseur de tissu
FR3081703A1 (fr) 2018-06-01 2019-12-06 Elenita Tiguert Procede et appareil de reconstruction mammaire
US11980394B2 (en) 2017-06-05 2024-05-14 Bateman Bottle, Llc Device for removal of implants and associated method of use

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5549672A (en) * 1991-12-26 1996-08-27 Mentor Corporation Method and apparatus for filling mammary prostheses and tissue expanders
US6039091A (en) * 1998-08-03 2000-03-21 Mentor Corporation Filling device for use in manufacturing of gel filled prostheses
US20060015084A1 (en) * 2001-11-05 2006-01-19 Ian Clarke Liquid dispenser
US20060142700A1 (en) * 2003-06-20 2006-06-29 Sobelman Owen S Two-way slit valve

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5549672A (en) * 1991-12-26 1996-08-27 Mentor Corporation Method and apparatus for filling mammary prostheses and tissue expanders
US6039091A (en) * 1998-08-03 2000-03-21 Mentor Corporation Filling device for use in manufacturing of gel filled prostheses
US20060015084A1 (en) * 2001-11-05 2006-01-19 Ian Clarke Liquid dispenser
US20060142700A1 (en) * 2003-06-20 2006-06-29 Sobelman Owen S Two-way slit valve

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11980394B2 (en) 2017-06-05 2024-05-14 Bateman Bottle, Llc Device for removal of implants and associated method of use
WO2019155326A1 (fr) * 2018-02-09 2019-08-15 Ethicon, Inc. Expanseur de tissu
US11382709B2 (en) 2018-02-09 2022-07-12 Mentor Worldwide Llc Tissue expander
US11911224B2 (en) 2018-02-09 2024-02-27 Mentor Worldwide Llc Tissue expander
FR3081703A1 (fr) 2018-06-01 2019-12-06 Elenita Tiguert Procede et appareil de reconstruction mammaire

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