Method of soft tissue augmentation

Inactive Publication Date: 2005-10-13
Q MED AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0038] In a preferred embodiment of the invention, the particles have a size in the range of from 1 to 2.5 mm, such as from 1.5 to 2 mm, in the presence of a physiological salt solution. These particles are suitable for administration to subcutaneous, submuscular or supraperiostal tissue. In particular, they are suitable for administration to tissues covered by skin that is exposed in public, such as facial tissue, since the particles and needles that are suitable for this particle size range are not likely to cause bruises or other discolorations. In a preferred embodiment, these particles are administered to deep subcutaneous or to submuscular/supraperiostal tissue, optionally in more than one layer. Deep subcutaneous or submuscular/supraperiostal administration further prevents or diminishes migration of the particles away from the desired site. According to this embodiment, a major volume, or more than 50% (v/v), preferably more than 70% (v/v), more preferably more than 90% (v/v), of the particles are within the given size limits under physiological conditions.
[0039] In another embodiment of the invention, the particles have a size in the range of from 2.5 to 5 mm, such as from 3 to 4 mm, in the presence of a physiological salt solution. Implants comprising such particles further prevents or diminishes migration of the particles away from the desired site. According to this embodiment, a major volume, or more than 50% (v/v), preferably more than 70% (v/v), more preferably more than 90% (v/v), of the particles are within the given size limits under physiological conditions.
[0040] Particle size may be determined i

Problems solved by technology

Some known soft-tissue augmentation treatments involving implantation of viscoelastic materials occasionally suffer from the drawback that the implant, or part thereof, migrates away from the desired site of treatment.
Another problem with some known tissue augmentation treatments involving implantation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of Gel Particles of Non-animal Stabilized Hyaluronic Acid

[0062] As previously exemplified in e.g. U.S. Pat. No. 5,827,937, 10 g of hyaluronic acid prepared by fermentation of Streptococcus was dissolved in 100 ml of 1% NaOH, pH>9. Cross-linking agent in the form of 1,4-butanediol diglycidyl ether was added to a concentration of 0.2%. The solution was incubated at 40° C. for 4 h.

[0063] The incubated solution was diluted with an acidic water solution to reach neutral pH under mixing, yielding a final hyaluronic acid concentration of 20 mg / ml, and again incubated for 12 h at 70° C. The viscoelastic slurry that resulted from this second incubation was then cooled to room temperature and mashed to its final particle size, approximately 1.5-2 mm.

example 2

Cheek and Chin Augmentation

Materials

[0064] A clear, colorless, viscoelastic gel consisting of non-animal stabilized hyaluronic acid (20 mg / ml) dispersed in physiological saline solution. The gel is obtainable e.g. by the method of example 1. The sterilized study material (2 ml) was supplied in a 3 ml glass syringe and was injected subcutaneously and / or supraperiostally using a sterilized 16 G×7 or 9 cm Coleman infiltration cannula with a blunt tip (Byron Medical Inc., Tucson, Ariz., USA).

Patient Selection and Study Design

[0065] Adult outpatients (>18 years of age) of either gender seeking cheek and / or chin augmentation therapy for aesthetic purposes. For study inclusion, patients were required to agree to abstain from other cosmetic procedures (e.g., further augmentation therapy, botulinum toxin injections, laser or chemical skin resurfacing or facelift procedures) for the duration of the study. Patients who had undergone facial tissue augmentation therapy or laser / chemical pe...

example 3

Preparation of Gel Particles of Non-animal Stabilized Hyaluronic Acid With Longer Duration

[0068] Ten grams of hyaluronic acid prepared by fermentation of Streptococcus was dissolved in 100 ml of 1% NaOH, pH>9. Cross-linking agent in the form of 1,4-butanediol diglycidyl ether was added to a concentration of 0.2%. The solution was incubated at 40° C. for 4 h.

[0069] The alkaline gel was divided in two portions, which were individually diluted with an acidic water solution to reach neutral pH under mixing, yielding final hyaluronic acid concentrations of 20 mg / ml and 25 mg / ml, respectively. The gels were incubated for 12 h at 70° C. and cooled to room temperature. The two gel portions were combined and mashed to the final particle size, approximately 3-4 mm.

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Abstract

Particles according to the invention are made of a viscoelastic medium, are injectable gel particles, and have a size, when subjected to a physiological salt solution, in the range of from 1 to 5 mm. The particles are useful in a soft tissue augmentation implant. The implant comprises particles of a viscoelastic medium, wherein a major volume of the particles are injectable gel particles according to the invention. The implant is useful in a method of soft tissue augmentation in a mammal, including man, comprising subepidermal administration at a site in said mammal where soft tissue augmentation is desirable, of an implant according to the invention.

Description

FIELD OF THE INVENTION [0001] The present invention relates to the fields of esthetics and plastic surgery, including cosmetic and reconstructive surgery. More specifically, the invention is concerned with a method of soft tissue augmentation in a mammal, including man. Moreover, the invention is directed to use of particles of a viscoelastic medium for the manufacture of a medicament for therapeutic soft tissue augmentation in a mammal, including man. The invention is also concerned with particles of a viscoelastic medium, production thereof, and use thereof in an implant. BACKGROUND TO THE INVENTION [0002] An implant material that is useful for soft-tissue augmentation should ideally be capable of providing adequate and sustained aesthetic and / or therapeutic correction without migration and displacement; natural-looking and non-palpable; easy to administer and, if necessary, remove; non-immunogenic; and devoid of chronic inflammatory reactions (Krauss M C, Semin Cutan Med Surg 199...

Claims

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Application Information

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IPC IPC(8): A61F2/00A61L15/20A61L15/52A61L15/58
CPCA61L15/20A61L15/52A61L27/50A61L27/20A61L15/58A61P43/00
Inventor AGERUP, BENGT
Owner Q MED AB
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