Gel suitable for implantation and delivery system

a gel and implantation technology, applied in the field of medical implant devices, can solve the problems of inability to rehydrate or resolve, change to polymers, undesirable final products, etc., and achieve the effects of convenient cellular ingrowth, high viscosity, and easy cellular ingrowth

Inactive Publication Date: 2005-08-25
KENSEY NASH CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0019] A need exists for a high viscosity material suitable for injection or in-situ molding supplied in dry form, which is readily and quickly rehydratable or resolvable upon addition

Problems solved by technology

It is commonly known that high energy sterilization (e.g., gamma irradiation, e beam radiation, etc.) results in changes to polymers (e.g., molecular weight loss, cross-linking, etc.) that may be undesirable in the final product.
It is also known that these changes are more severe when the product is in a hydrated or solvated state.
Delmotte does not address the need for a material that does not require milling or grinding before the addition of

Method used

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  • Gel suitable for implantation and delivery system
  • Gel suitable for implantation and delivery system
  • Gel suitable for implantation and delivery system

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0097] A single 0.1-gram porous collagen sheet of matrix material is placed in a shallow dish and covered with 1.9 grams of buffered saline at a pH of 7.4 that is allowed to soak in and spread across the internal surfaces of the pores by capillary rehydration. After 1 minute the sheet is kneaded and compressed by hand while folding any dry areas into the moist center of the mass to create approximately 2 cc of 5% putty. A putty made in this manner has a viscoelastic property similar to soft tissue, and thus makes an ideal augmentation material.

example 2

[0098] The 5% putty from Example 1 was placed into a small container and covered with 40 cc of buffered saline at a pH of 7.4. After 4 hours the material is still intact with no sign of softening, swelling or taking on moisture. The putty is then kneaded and compressed while in contact with 1 gram of buffered saline at a pH of 7.4 to create approximately 3 cc of 3.3% putty. A putty made in this manner is easily injected through long needles and thus makes an ideal deep injection augmentation material.

example 3

[0099] A single 0.1-gram porous collagen sheet of matrix material is rolled and placed into a 10 cc syringe. Using a 14 g I.V. needle, 1.9 grams of buffered saline at a pH of 7.4 is injected from a separated delivery syringe into the bottom of the syringe containing the rolled collagen sheet. After removing the needle, the plunger to the syringe containing the rolled collagen and saline is depressed, crushing the porosity of the hydrated region of the sponge and forcing the fluid into the non-hydrated portions of the sponge. Once fully hydrated, a syringe cap is placed over the opening and the plunger compressed to pressurize the interior of the syringe and solvate the polymer. The cap is removed and smooth, homogeneous 5% putty is expelled from the syringe. This material has physical properties identical to example 1.

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Abstract

The invention concerns a dried form of a porous polymer gel material which may be rehydrated and placed under pressure or compression to induce solvation, thereby forming a high concentration gel, in the form of an injectable viscous putty or dough, which may be implantated in the body.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] This application relates generally to medical implant devices and methods of use, specifically relating to the preparation of an implantable device, the sterilization and storage of the device, and the use and delivery of the device. The material of the present invention may serve as an implantable material in order to aid tissue healing, serve as a void filler, prevent adhesions, and / or serve as a drug delivery vessel, among other beneficial uses. [0003] 2. Discussion of Related Art [0004] Hydrogels may be formed from a variety of polymeric materials and are useful in a variety of biomedical applications, for example, wound management, soft contact lens construction, surgical applications, and drug delivery applications. To be suitable for implantation in a living being, the polymer material should be sterile to minimize opportunity for infection. An implantable polymer material may be manufactured through an asept...

Claims

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Application Information

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IPC IPC(8): A61L27/20A61L27/24A61L27/52A61L27/56
CPCA61L27/20A61L27/24A61L27/52A61L27/56C08L5/08
Inventor RINGEISEN, TIMOTHY A.WATTENGEL, WILLIAM CHRISTIAN
Owner KENSEY NASH CORP
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