Implantation Compositions for Use in Tissue Augmentation

Abstract

A composition of matter and method for preparation of a tissue augmentation material. A polysaccharide gel composition is prepared with rheological properties selected for a particular selected application. The method includes preparing a polymeric polysaccharide in a buffer to create a polymer solution or gel suspending properties in the gel and selecting a rheology profile for the desired tissue region.

1 . A method of preparing an implant with a desired rheological property selected to be compatible with at least one tissue rheological feature and at least one acceptable tissue rheological range at a tissue site of implantation, the method comprising:
 establishing at least one of a particular rheological feature and an acceptable rheological range characteristic of the tissue at the tissue implantation site;   identifying an implant having at least one of the at least one particular rheological feature and the acceptable range; and   preparing the implant having the desired rheological property.   
     
     
         2 . The method as defined in  claim 1  wherein the step of identifying an implant with the at least one particular rheological feature and acceptable rheological range comprises;
 collecting data for a plurality of test implants, the data being characteristic of chemical variables and rheological variables for each of the plurality of test implants; and   mapping the data to define at least one of characteristic phase lines and characteristic closed phase region which meet the at least one particular rheological feature and acceptable rheological range for the rheological property   
     
     
         3 . The method as defined in  claim 1  wherein the step of mapping the data comprises establishing the characteristic closed phase region within which a plurality of the chemical variables provide the implant having a plurality of associated rheological properties compatible with the tissue at the implantation site. 
     
     
         4 . The method as defined in  claim 1  wherein the step of identifying an implant includes establishing sensitivity of changes in the rheological property of the implant as a function of change in chemical variables. 
     
     
         5 . The method as defined in  claim 1  further including the step of establishing statistical boundaries for at least one of the characteristic phase lines and the characteristic closed phase region. 
     
     
         6 . The method as defined in  claim 1  wherein the particular rheological feature comprises a cross-over of functionality of G′ and G″. 
     
     
         7 . The method as defined in  claim 1  wherein the rheological property comprises compatibility of phase angle versus frequency for the implant and the tissue. 
     
     
         8 . The method as defined in  claim 1  wherein the implant comprises a polysaccharide polymer. 
     
     
         9 . The method as defined in  claim 1  wherein the implant comprises a polysaccharide polymer having an Fo value of at least about 22. 
     
     
         10 . The method of  claim 9 , wherein the polysaccharide polymer is selected from the group consisting of an alginate polysaccharide, a cellulose polysaccharide and a hemicellulose polysaccharide. 
     
     
         11 . The method of  claim 9 , wherein the cellulose based polysaccharide polymer is selected from the group consisting of: sodium carboxymethylcellulose, hydroxyethyl cellulose, ethylhydroxyethyl cellulose, carboxymethyl cellulose, carboxyethylhydroxyethyl cellulose, hydroxypropylhydroxyethyl cellulose, methyl cellulose, methylhydroxylmethyl cellulose, methylhydroxyethyl cellulose, carboxymethylmethyl cellulose, and modified derivatives thereof. 
     
     
         12 . The method as defined in  claim 1  wherein the step of preparing the implant includes addition of a buffer. 
     
     
         13 . The method of  claim 12  wherein the buffer comprises a potassium phosphate. 
     
     
         14 . The method as defined in  claim 1  wherein the step of preparing the implant includes adding a lubricant. 
     
     
         15 . The method as defined in  claim 14  wherein the lubricant comprises glycerin. 
     
     
         16 . The method as defined in  claim 1  wherein the step of preparing the implant comprises adding particles. 
     
     
         17 . The method as defined in  claim 16  wherein the particles comprise a ceramic. 
     
     
         18 . The method as defined in  claim 17  wherein the ceramic particles have a size range of about 20 to 200 microns and have a volume percent of about 5 to 65 percent. 
     
     
         19 . A tissue implant product for a tissue site comprising:
 a polysaccharide polymer having an Fo value between about 22 and 34 and a buffer component, wherein rheology parameters of the implant product include a cross-over of G′ and G″ and phase frequency functionality of the implant product exhibits a behavior in three regions of tissue functionality of the same category as the tissue site.   
     
     
         20 . The tissue implant product as defined in  claim 19  further including the feature that phase frequency functionality of the implant product exhibits a behavior in three regions of tissue functionality of the same category as the tissue site. 
     
     
         21 . The tissue implant product as defined in  claim 19  further including a rheological feature requirement for the implant product of being within a phase region meeting a plurality of rheological parameters characteristic of the tissue site. 
     
     
         22 . An implant having a rheological properly selected to be compatible with tissue at an implant site, prepared in accordance with a method comprising the steps of:
 establishing at least one required rheological feature for the tissue at the implant sites;   identifying an implant having the required rheological feature; and   preparing the implant having the required rheological feature so as to be compatible with the tissue at the implant site.   
     
     
         23 . The implant as defined in  claim 22  wherein the steps of identifying an implant includes establishing at least one chemical variable associated with the required rheological feature. 
     
     
         24 . The implant as defined in  claim 22  wherein the step of identifying an implant having the required rheological feature comprises mapping the at least one required rheological feature versus a plurality of chemical variables to identify a combination of the chemical variables which enables meeting the at least one required rheological feature. 
     
     
         25 . The implant as defined in  claim 24  wherein the at least one required rheological feature comprises G′ and G″ functional behavior intersecting each other between about 0.1-10 Hz tissue response. 
     
     
         26 . The implant as defined in  claim 25  wherein G″ is greater than G′ until intersection. 
     
     
         27 . The implant as defined in  claim 24  wherein the step of mapping the at least one required rheological feature comprises statistical analysis of changing the chemical variables to establish at least one of a line and a volume of desirability associated with an implant rheological feature which is compatible with the at least required rheological feature. 
     
     
         28 . A method for identifying an implant for a selected tissue implant site of a particular type of patient, the method comprising:
 a supplier providing a clinician rheological data for tissue of a particular type of patient at a prospective tissue implant site; and   a clinician reviewing data from the supplier of a plurality of potentially useful implant products, the data from the supplier providing (a) information on the rheological properties of each of the plurality of the implant products and (b) further indicating whether the rheological properties will meet compatibility requirements for the particular type of patient tissue at the implant site.   
     
     
         29 . The method as defined in  claim 28  wherein the data from the supplier includes information on change of a rheological parameters for the implant as a function of change of chemical variables of the implant. 
     
     
         30 . A method of implanting a tissue augmentation product in a patient, comprising the steps of:
 characterizing a tissue in a particular type of patient;   reviewing data from a supplier which includes identifying a tissue augmentation product having rheological properties compatible with the tissue of the particular type of patient; and   implanting the tissue augmentation product in the patient in accordance with the data from the supplier.   
     
     
         31 . A method of establishing a treatment protocol for implantation of a tissue augmentation product which is compatible with a patient tissue site, comprising the steps of:
 identifying particular rheological properties associated with tissue of a particular type of patient;   providing implant rheological data for a plurality of tissue augmentation products; and   identifying selected tissue augmentation products which have implant theological data which is indicative of being compatible with the tissue of the particular type of patient.   
     
     
         32 . The method as defined in  claim 31  wherein the tissue of the particular type of patient is selected from the group consisting of:
 vocal fold, nasolabial folds, marionette lines, cheek augmentation, lips, urinary tract, and wrinkles and folds.