US5336263A — Treatment of urological and gastric fluid reflux …

Claim 1

Independent Claim 125 words

A method for long-term treatment of urological and gastric disorders comprising the step of injecting submucosally or peri-urethrally into tissue at at least one injection site a composition comprising an effective amount of relatively soft, malleable, elastic, biologically compatible prosthetic micro particles dispersed in a non-retentive compatible physiological vehicle comprising polyvinyl pyrrolidone, the micro particles of the composition further being of a designed average particle size distribution and characterized by a rough surface having a plurality of surface irregularities generally randomly formed therein, such that the effects of average particle size and average particle surface roughness cooperate in combination in an autogenous manner to essentially prevent loss of the micro particles from any injection site, the particles remaining to be incorporated as long-term tissue augmentation.

Claim 2

Independent Claim 125 words

A method for long-term treatment of urological and gastric disorders comprising the step of injecting submucosally or peri-urethrally into tissue at at least one injection site a composition comprising an effective amount of relatively soft, malleable, elastic, biologically compatible prosthetic micro particles dispersed in a non-retentive compatible physiological vehicle comprising polyvinyl pyrrolidone, the micro particles of the composition further being of a designed average particle size distribution and characterized by a rough surface having a plurality of surface irregularities generally randomly formed therein, such that the effects of average particle size and average particle surface roughness cooperate in combination in an autogenous manner to essentially prevent loss of the micro particles from any injection site, the particles remaining to be incorporated as long-term tissue augmentation.

Claim 3

Dependent Claim 29 words

A method as defined in claim 1 wherein the micro particles possess an average unidimensional particle size in the range of from about 100 microns to about 600 microns.

Claim 4

Dependent Claim 14 words

A method as defined in claim 1 wherein the micro particles comprise a polysiloxane.

Claim 5

Dependent Claim 14 words

A method as defined in claim 2 wherein the micro particles comprise a polysiloxane.

Claim 6

Dependent Claim 13 words

A method as defined in claim 2 wherein the micro particles are polydimethylsiloxane.

Claim 7

Independent Claim 163 words

A method for long-term treatment of incontinence comprising the steps of making a plurality of spaced injections into the submucosal layer of the urethra of a composition comprising an amount of relatively soft, malleable, elastic, biologically compatible prosthetic micro particles dispersed in a non-retentive compatible physiological vehicle comprising polyvinyl pyrrolidone, the micro particles of the composition further being of a designed average unidimensional particle size distribution between 30 and 3000 microns, and characterized by a rough surface having a plurality of surface irregularities generally randomly formed therein, characterized by indentations, cavities and pores forming openings upon the surface of the particles, with the dimensions of the indentations, cavities and pores being generally in a range between 10 angstroms and 500 microns, such that the effects of average particle size and average particle surface roughness cooperate in combination in an autogenous manner to essentially prevent loss of the micro particles from any injection site, the particles remaining to be incorporated as long-term tissue augmentation.

Claim 8

Independent Claim 163 words

A method for long-term treatment of incontinence comprising the steps of making a plurality of spaced injections into the submucosal layer of the urethra of a composition comprising an amount of relatively soft, malleable, elastic, biologically compatible prosthetic micro particles dispersed in a non-retentive compatible physiological vehicle comprising polyvinyl pyrrolidone, the micro particles of the composition further being of a designed average unidimensional particle size distribution between 30 and 3000 microns, and characterized by a rough surface having a plurality of surface irregularities generally randomly formed therein, characterized by indentations, cavities and pores forming openings upon the surface of the particles, with the dimensions of the indentations, cavities and pores being generally in a range between 10 angstroms and 500 microns, such that the effects of average particle size and average particle surface roughness cooperate in combination in an autogenous manner to essentially prevent loss of the micro particles from any injection site, the particles remaining to be incorporated as long-term tissue augmentation.

Claim 9

Dependent Claim 29 words

A method as defined in claim 6 wherein the micro particles possess an average unidimensional particle size in the range of from about 100 microns to about 600 microns.

Claim 10

Dependent Claim 15 words

A method is defined in claim 6 wherein the micro particles comprise a polysiloxane material.

Claim 11

Dependent Claim 14 words

A method as defined in claim 7 wherein the micro particles comprise a polysiloxane.

Claim 12

Independent Claim 170 words

A method for long-term treatment of gastric reflux comprising the steps of making a plurality of injections at spaced sites into the appropriate submucosal space selected from the esophageal-gastric junction and gastric-pyloric junction a composition comprising an amount of relatively soft, malleable, elastic, biologically compatible micro particles dispersed in a non-retentive compatible physiological vehicle comprising polyvinyl pyrrolidone, the micro particles of the composition further being of a designed average unidimensional particle size distribution between 30 and 3000 microns, and characterized by a rough surface having a plurality of surface irregularities generally randomly formed therein, characterized by indentations, cavities and pores forming openings upon the surface of the particles, with the dimensions of the indentations, cavities and pores being generally in a range between 10 angstroms and 500 microns, such that the effects of average particle size and average particle surface roughness cooperate in combination in an autogenous manner to essentially prevent loss of the micro particles from any injection site, the particles remaining to be incorporated as long-term tissue augmentation.

Claim 13

Independent Claim 170 words

A method for long-term treatment of gastric reflux comprising the steps of making a plurality of injections at spaced sites into the appropriate submucosal space selected from the esophageal-gastric junction and gastric-pyloric junction a composition comprising an amount of relatively soft, malleable, elastic, biologically compatible micro particles dispersed in a non-retentive compatible physiological vehicle comprising polyvinyl pyrrolidone, the micro particles of the composition further being of a designed average unidimensional particle size distribution between 30 and 3000 microns, and characterized by a rough surface having a plurality of surface irregularities generally randomly formed therein, characterized by indentations, cavities and pores forming openings upon the surface of the particles, with the dimensions of the indentations, cavities and pores being generally in a range between 10 angstroms and 500 microns, such that the effects of average particle size and average particle surface roughness cooperate in combination in an autogenous manner to essentially prevent loss of the micro particles from any injection site, the particles remaining to be incorporated as long-term tissue augmentation.

Claim 14

Dependent Claim 29 words

A method as defined in claim 10 wherein the micro particles possess an average unidimensional particle size in the range of from about 100 microns to about 600 microns.

Claim 15

Dependent Claim 15 words

A method is defined in claim 10 wherein the micro particles comprise a polysiloxane material.

Claim 16

Dependent Claim 15 words

A method is defined in claim 11 wherein the micro particles comprise a polysiloxane material.

Claim 17

Independent Claim 129 words

A method for long-term treatment of urological and gastric disorders comprising the step of injecting submucosally or peri-urethrally into tissue at at least one injection site a composition comprising an effective amount of relatively soft, malleable, elastic, biologically compatible prosthetic micro particles, characterized by a rough surface having a plurality of irregularities generally randomly formed therein, and dispersed in a non-retentive, non-retained compatible physiological vehicle, wherein the vehicle is eliminated from the injection site and the micro particles being an average particle size distribution and surface roughness such that the effects of average particle size and average particle surface roughness cooperate in combination in an autogenous manner to essentially prevent loss of the micro particles from any injection site, the particles remaining to be incorporated as long-term tissue augmentation.

Claim 18

Independent Claim 129 words

A method for long-term treatment of urological and gastric disorders comprising the step of injecting submucosally or peri-urethrally into tissue at at least one injection site a composition comprising an effective amount of relatively soft, malleable, elastic, biologically compatible prosthetic micro particles, characterized by a rough surface having a plurality of irregularities generally randomly formed therein, and dispersed in a non-retentive, non-retained compatible physiological vehicle, wherein the vehicle is eliminated from the injection site and the micro particles being an average particle size distribution and surface roughness such that the effects of average particle size and average particle surface roughness cooperate in combination in an autogenous manner to essentially prevent loss of the micro particles from any injection site, the particles remaining to be incorporated as long-term tissue augmentation.

Claim 19

Dependent Claim 68 words

A method as defined in claim 14 wherein the surface irregularities of the micro particles describe indentations, cavities and pores forming a very irregular surface including openings within the particles, the micro particles having an average unidimensional particle size generally between 30 and 3000 microns with the dimensions of the indentations, cavities and pores within the particles being generally in a range between 10 angstroms and 500 microns.

Claim 20

Dependent Claim 11 words

The method of claim 15 wherein the vehicle comprises polyvinyl pyrrolidone.

Claim 21

Dependent Claim 22 words

A method as defined in claim 15 wherein the micro particles possess an average unidimensional particle size of 100 microns or more.

Claim 22

Dependent Claim 35 words

A method as defined in claim 17 wherein the composition is injected into a submucosal space selected from the bladder-urethral junction, the esophageal-gastric junction and the gastric-pyloric junction using a plurality of spaced injection sites.

Claim 23

Dependent Claim 25 words

A method as defined in claim 16 wherein the composition is injected under the intravesical portion of the ureter using a plurality of spaced injections.

Claim 24

Dependent Claim 25 words

A method as defined in claim 17 wherein the composition is injected under the intravesical portion of the ureter using a plurality of spaced injections.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1997-08-08	1998-02-07	1998-08-09	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2001-08-08	2002-02-07	2002-08-09	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2005-08-08	2006-02-07	2006-08-09	$7700.00	Window Closed / Lapsed

Treatment of urological and gastric fluid reflux disorders by injection of mmicro particles

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