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Methods and Compositions for Tissue Augmentation

a tissue and composition technology, applied in the field of biphasic and single phase compositions for soft tissue volume replacement, to achieve the effect of preventing migration and preventing ingestion by macrophages

Inactive Publication Date: 2008-03-27
DYER WALLACE K
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0028] Another object of the present invention is to provide compositions comprising particles of a size that are large enough to prevent ingestion by macrophages and to prevent migration to distant sites after implantation.
[0029] It is another object of the present invention to provide methods for tissue augmentation and compositions that are moldable following implantation, but stable after remolding, and that mimic the consistency of the tissue that it replaces.

Problems solved by technology

Such polymers may remain solid within the body for a long time or may be resorbed by the body in a few weeks.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0058] The preparation of the intradermal sites to be injected are cleansed initially with a germicidal soap such as Hibiclens®. The patient is then marked in the upright position with a fine surgical marking pen and those areas marked are lightly swabbed with alcohol prior to injection with the patient in the supine position. Diffuse overhead light is the best illumination when injecting the face. A bright light directed onto the face does not allow shadows to be cast which further identify the lines, depressions, scars, etc. that are outlined in ink. The serial puncture technique is utilized: the thumb is placed one centimeter behind the index finger as both digits of the left hand (if one is right-handed) straddle and raise the affected area. The needle is repeatedly inserted (at an oblique angle) into the skin between the thumb and finger at intervals of several millimeters along the course of the wrinkle, depression or area to be augmented.

[0059] This Example is directed to in...

example 2

[0060] Common cosmetic applications include intramuscular lip augmentation and subcutaneous augmentation of the nasolabial creases. Special blunt 20-gauge cannulas measuring about 4 inches in length are attached to a leveraged “gun” that receives syringe cartridges. This gun allows very precise injection of the material in small, evenly spaced quantities of the biphasic augmentation material. First the area to be treated is outlined with a pen, and the estimated volume is recorded. This area is then injected with lidocaine with epinephrine to provide anesthesia and to minimize bleeding. Through a remote puncture site, the blunt cannula is then introduced to the subcutaneous tissue. In a scarred area such as a cleft lip, it may be necessary to pretunnel with a pencil tip trocar to create a series of sponge-like channels to accept the material without bunching or beading. In the uninjured lip for augmentation, no such pretunneling is required, and the blunt cannula is simply passed to...

example 3

[0061] Subcutaneous cosmetic augmentation of the nasolabial creases and reconstructive augmentation of iatrogenic or traumatic lipodystrophy (dents due to subcutaneous fat loss) are performed in a similar fashion. After careful demarcation of the proposed augmentation site, the entire area is injected with Xylocalne 1% with epinephrine 1:100,000, providing the local block needed as well as hemostasis. A remote puncture is then performed with a 18-gauge sharp needle on each side of the area for augmentation, peripheral to the outlined area, so that 1 to 2 cm of “no-man's land” isolates the puncture sites from the area of planned implantation. Pretunneling is done in various planes. The microparticles are then implanted from the same remote puncture site by means of the injection gun. Injection is done only on withdrawal, mimicking the path and technique of the pocar and injecting only to the midline. The cannula is kept in constant motion, and trigger pressure is gently maintained on...

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Abstract

Methods and compositions for use in tissue volume replacement are provided. The present invention comprises compositions comprising a combination of materials, comprising preferably a solid polymer particle phase and a gel phase, and also comprises single phase compositions. More particularly, preferred embodiments comprise a solid polymer particle phase made of materials comprising Gore-Tex (micronized e-PTFE), PDS II (polydioxanone, a monofilament), NUROLON (a long chain aliphatic polymer Nylon 6 or Nylon 6,6) ETHILON (a long chain aliphatic polymer Nylon 6 and Nylon 6,6), PROLENE (Polypropylene, isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin.), VICRYL (copolymer made from 90% glycolide and 10% L-lactide), silk, MONACRYL (poly ε-caprolactone.), polylactide, polyglycolide, poly lactide-co-glycolide, and BIOPOL (polyhydroxyvalerate), MEDPOR (biocompatible (micronized) polyethylene), BIOGLASS (bioactive glass particulate), NOVABONE and NOVABONE-CM, and the gel phase comprises polyvinylpyrrolidone (PVP). Preferred single phase compositions comprise PVP. Methods of the present invention comprising injection of such compositions for tissue augmentation.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional No. 60 / 229,085 filed Aug. 30, 2000, and to U.S. Provisional Application No. 60 / 229,989 filed Sep. 5, 2000, and to U.S. Provisional No. 60 / 241,636 filed Oct. 19, 2000.TECHNICAL FIELD [0002] This application relates to novel biphasic and single phase compositions for soft tissue volume replacement, and methods of use of such compositions. In addition, the present invention relates to methods for use of such compositions as material in plastic and reconstructive surgery. BACKGROUND OF THE INVENTION [0003] Plastic and reconstructive surgeons have long sought to develop a safe, predictable, and injectable material for soft tissue volume replacement. Surgeons seek not just to add bulk, but also to restore normal tissue consistency and composition. At present, injectable implant material can be designed to be tolerated by the host and to mimic the tissue it is designed to replace or augment....

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/74A61P43/00A61L27/14
CPCA61K9/0019A61L2400/06A61L27/14A61K31/74A61K8/0241A61K8/8123A61K8/8176A61K2800/91A61P43/00A61Q19/00A61Q19/08A61K8/85A61K9/1635A61K9/1647A61K2800/412A61K2800/594
Inventor DYER, WALLACE K.
Owner DYER WALLACE K
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