Soft tissue substitute and method of soft tissue reformation

Abstract

A soft tissue implant material is formed from biologically-compatible polymeric particles. The particles may have a diameter of up to about 500 microns and intraparticulate pores sized for ingrowth of soft tissue. The particles may have an inner core of a first biologically-compatible polymeric material and an outer layer generally surrounding the inner core, with the outer layer comprised of a second biologically-compatible polymeric material being hydrophilic and having a composition different from the composition of the first polymeric material. The material may be utilized with collagen or other matrix materials. This material may be used in a method of reforming soft tissues by implanting the material within soft body tissues to modify soft tissue defects such as wrinkles; or oral gingival tissue defects and reshape soft tissue, e.g., for urinary bladder inconvenience.

1 . A method of augmenting soft tissue comprising: 
 a. providing a biologically compatible implant material comprised of at least partially non-resorbable biologically compatible polymeric particles having calcium hydroxide thereon, wherein said particles have interstices therebetween with dimensions effective to permit soft tissue to grow therein; and    b. implanting said implant material within soft tissue.    
   
   
       2 . Method of  claim 1  wherein said implanting step includes the step of injecting said implant material.  
   
   
       3 . Method of  claim 2  wherein said injecting step includes injecting said implant material subcutaneously into an area having a soft tissue contour defect in an amount sufficient to at least partially remove said defect.  
   
   
       4 . Method of  claim 3  wherein said soft tissue contour defect comprises wrinkles.  
   
   
       5 . Method of  claim 3  wherein said soft tissue contour defect includes gingival soft tissue defects in the mouth.  
   
   
       6 . Method of  claim 2  wherein said injecting step includes injecting said material into the sphincter surrounding the urethra in an amount sufficient to at least partially constrict said urethra.  
   
   
       7 . Method of  claim 6  wherein said injecting step includes injecting between about 2 cc and about 4 cc of said implant material.  
   
   
       8 . Method of  claim 1  wherein said particles have a diameter of up to about 500 microns.  
   
   
       9 . Method of  claim 8  wherein said particles have a diameter of about 50 to about 200 microns.  
   
   
       10 . Method of  claim 1  wherein said particles have intraparticulate pores, said pores having dimensions effective to permit soft tissue to grow therein.  
   
   
       11 . Method of  claim 10  wherein said pores comprise up to about 60 percent of said material.  
   
   
       12 . Method of  claim 11  wherein said pores comprise between about 40 and about 60 percent of said material.  
   
   
       13 . Method of  claim 10  wherein said pores have a size of less than about 100 microns.  
   
   
       14 . Method of  claim 13  wherein said pores have a size of between about 50 and about 100 microns.  
   
   
       15 . Method of  claim 1  wherein said particles have an inner core comprised of a first biologically-compatible polymeric material and an outer layer generally surrounding said inner core, said outer layer comprised of a second biologically-compatible polymeric material, said second polymeric material being hydrophilic and having a composition different from the composition of said first polymeric material.  
   
   
       16 . Method of  claim 15  wherein said first polymeric material is an acrylic polymer.  
   
   
       17 . Method of  claim 16  wherein said first polymeric material is polymethylmethacrylate.  
   
   
       18 . Method of  claim 15  wherein said second polymeric material is a polymeric hydroxyethylmethacrylate.  
   
   
       19 . Method of  claim 18  wherein said polymeric hydroxyethylmethacrylate comprises a copolymer of monomeric hydroxyethylmethacrylate and a cross-linking agent.  
   
   
       20 . Method of  claim 1  wherein the step of providing a biologically compatible implant material further comprises combining said particles with a matrix material.  
   
   
       21 . Method of  claim 20  wherein said matrix material comprises a volume of between about 30% and about 65% of the volume of said implant material.  
   
   
       22 . Method of  claim 21  wherein said matrix material comprises a volume of about 50% of the volume of said implant material.  
   
   
       23 . Method of  claim 20  wherein said matrix material is selected from the group consisting of sterile water, saline solution, adipose tissue, blood, glucose, hyaluronic acid, and collagen.  
   
   
       24 . Method of  claim 23  wherein said matrix material comprises collagen.  
   
   
       25 . Method of  claim 24  wherein said collagen comprises injectable collagen.  
   
   
       26 . Method of  claim 1  wherein the step of providing a biologically compatible implant material further comprises the step of combining said particles with at least one bioactive substance.  
   
   
       27 . Method of  claim 26  wherein the combining step includes grafting said at least one bioactive substance to said particles.  
   
   
       28 . Method of  claim 1 , wherein said implanting step comprises implanting said implant material in particulate form.  
   
   
       29 . Method of  claim 1 , wherein said polymeric particles are non-resorbable.  
   
   
       30 . A method of augmenting soft tissue comprising: 
 a. providing a biologically compatible implant material comprising particles having an inner core comprised of polymethylmethacrylate and an outer layer generally surrounding said inner core comprised of polymeric hydroxyethylmethacrylate, said particles having interstices therebetween with dimensions effective to permit soft tissue to grow therein; and    b. implanting said implant material within soft tissue in particulate form.    
   
   
       31 . Method of  claim 30  wherein said implanting step includes the step of injecting said implant material.  
   
   
       32 . Method of  claim 31  wherein said injecting step includes injecting said implant material subcutaneously into an area having a soft tissue contour defect in an amount sufficient to at least partially remove said defect.  
   
   
       33 . Method of  claim 32  wherein said soft tissue contour defect comprises wrinkles.  
   
   
       34 . Method of  claim 32  wherein said soft tissue contour defect includes gingival soft tissue defects in the mouth.  
   
   
       35 . Method of  claim 31  wherein said injecting step includes injecting said material into the sphincter surrounding the urethra in an amount sufficient to at least partially constrict said urethra.  
   
   
       36 . Method of  claim 35  wherein said injecting step includes injecting between about 2 cc and about 4 cc of said implant material.  
   
   
       37 . Method of  claim 30  wherein said particles have a diameter of up to about 500 microns.  
   
   
       38 . Method of  claim 37  wherein said particles have a diameter of about 50 to about 200 microns.  
   
   
       39 . Method of  claim 30  wherein said particles have intraparticulate pores, said pores having dimensions effective to permit soft tissue to grow therein.  
   
   
       40 . Method of  claim 30 , wherein said particles have an amount of calcium hydroxide thereon effective to induce soft tissue growth.  
   
   
       41 . Method of  claim 40  wherein said pores comprise up to about 60 percent of said material.  
   
   
       42 . Method of  claim 41  wherein said pores comprise between about 40 and about 60 percent of said material.  
   
   
       43 . Method of  claim 40  wherein said pores have a size of less than about 100 microns.  
   
   
       44 . Method of  claim 43  wherein said pores have a size of between about 50 and about 100 microns.  
   
   
       45 . Method of  claim 30  wherein the step of providing a biologically compatible implant material further comprises combining said particles with a matrix material.  
   
   
       46 . Method of  claim 45  wherein said matrix material comprises a volume of between about 30% and about 65% of the volume of said implant material.  
   
   
       47 . Method of  claim 45  wherein said matrix material comprises a volume of about 50% of the volume of said implant material.  
   
   
       48 . Method of  claim 45  wherein said matrix material is selected from the group consisting of sterile water, saline solution, adipose tissue, blood, glucose, hyaluronic acid, and collagen.  
   
   
       49 . Method of  claim 48  wherein said matrix material comprises collagen.  
   
   
       50 . Method of  claim 49  wherein said collagen comprises injectable collagen.  
   
   
       51 . Method of  claim 30  wherein the step of providing a biologically compatible implant material further comprises the step of combining said particles with at least one bioactive substance.  
   
   
       52 . Method of  claim 51  wherein the combining step includes grafting said at least one bioactive substance to said particles.