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Details
Inventors: Berg, Eric P.;
Assignee: American Medical Systems, Inc. (Minnetonka, MN)
Primary Examiner: Cannon; Alan W.
Assistant Examiner:
Attorney, Agent or Firm: Richardson; Peter C., Akers; Lawrence C., Dryer; Mark

An injectable composition comprising a plurality of discrete physiologically-compatible, non-biodegradable, polymeric bodies, said bodies having (i) an average outside diameter of from about 0.005 to 0.20 inch, (ii) reversible deformability of about 20 to 75% of their unstressed outside diameter, and (iii) a lubricious surface; a process for the preparation of said composition and a method for treating a tissue condition in a patient using said composition.

DETAILED DESCRIPTION OF THE INVENTION The injectable composition of the invention consists of discrete bodies of a particular size and possessing unique characteristics which enable them to be injectable, i.
e.
to be introduced into and contained within a hypodermic needle, without the aid of a carrier or solvent.
Thus the injectable composition may not be in the form of a traditional solution, suspension or paste, but merely may comprise a plurality of the above-described discrete bodies themselves.
The injectability of the bodies is particularly surprising because in many instances the average size of the bodies is greater than the inside diameter of the needle in which they are to be used.
Thus, as more particularly described hereinafter, when the bodies are in the preferred form of macrodisks, the average outside diameter of the macrodisks may be up to about three times the inside diameter of a hypodermic needle through which they may be successfully passed without undergoing observable damage.
The unique and surprising injectability of the discrete bodies which form the composition of the invention may be attributed primarily to the characteristics which are defined herein as reversible deformability and lubricious surface.
As used herein the term "reversible deformability" means that the bodies are sufficiently flexible to be deformed into virtually any shape by folding, compression or both when subjected to the physical stress required to produce the relevant deformation, for example the deformation required to introduce the bodies into a hypodermic needle, but return to their original shape and size when said stress is removed, e.
g.
when they are expressed from the needle.
It is also essential that each discrete body has a lubricious surface, i.
e.
said surface must be sufficiently smooth and slippery so that the bodies do not stick to any surface with which they come into contact during the performance of the invention, for example, the inside surface of a hypodermic needle, nor do they stick to themselves



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