US2008003255A1PendingUtilityA1

Method for augmenting, reducing, and repairing bone with thermoplastic materials

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Assignee: SYNTHES USAPriority: May 10, 2006Filed: May 10, 2007Published: Jan 3, 2008
Est. expiryMay 10, 2026(expired)· nominal 20-yr term from priority
Inventors:Sean KerrAli Cem Recber
A61P 29/00A61P 31/00A61K 9/0024A61B 17/8855A61B 17/8805A61B 17/1615A61P 19/08A61B 17/68A61B 17/686A61B 17/7097A61B 17/84A61B 17/8802B29C 70/84B29K 2067/00B29K 2711/06B29L 2031/7532B29C 35/08B29C 65/70B29C 2035/085B29C 73/02A61B 17/7098A61B 17/8833
56
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Claims

Abstract

A method for augmenting a tissue including introducing into the tissue a first thermoplastic material at a first condition; treating the first thermoplastic material to achieve a second condition that includes an at least partially crystalline skin; and introducing a second material into the tissue whereby the first thermoplastic material and the second material are contained by the at least partially crystalline skin. Also a method of fracture reduction in a tissue including exposing to gamma radiation a mass of polycaprolactone characterized by a first shape; heating the mass of irradiated polycaprolactone above its melting temperature; introducing the heated mass of polycaprolactone into the tissue annulus to deform it from the first shape; allowing the material to return to the first shape.

Claims

exact text as granted — not AI-modified
1 . A method for augmenting a tissue comprising the steps of: 
 introducing into the tissue a first thermoplastic material at a first condition;    treating the first thermoplastic material to achieve a second condition that includes an at least partially crystalline skin; and    introducing a second material into the tissue whereby the first thermoplastic material and the second material are contained by the at least partially crystalline skin.    
     
     
         2 . The method of  claim 1 , wherein the introducing the second material causes the at least partially crystalline skin to expand.  
     
     
         3 . The method of  claim 1  further comprising forcing the at least partially crystalline skin against at least a portion of the tissue in response to the introduction of second material into the first thermoplastic material.  
     
     
         4 . The method of  claim 1 , wherein the second material comprises thermoplastic material.  
     
     
         5 . The method of  claim 1 , wherein at least one of either the first thermoplastic material or the second material comprises polycaprolactone.  
     
     
         6 . The method of  claim 1 , wherein the first thermoplastic material and the second material comprise the same thermoplastic material.  
     
     
         7 . The method of  claim 1 , wherein the tissue comprises bone.  
     
     
         8 . The method of  claim 1 , wherein the first condition comprises a flowable state.  
     
     
         9 . The method of  claim 1 , wherein the step of treating the first thermoplastic material comprises changing the temperature of the first thermoplastic material.  
     
     
         10 . The method of  claim 1 , wherein the step of treating the first thermoplastic material comprises cooling the first thermoplastic material.  
     
     
         11 . The method of  claim 1 , wherein the second condition comprises a semi-solid state.  
     
     
         12 . The method of  claim 3 , wherein the step of forcing the at least partially crystalline skin against at least a portion of the tissue comprises displacing at least a portion of the tissue.  
     
     
         13 . The method of  claim 2 , wherein the tissue comprises cancellous bone, and wherein the method further comprises the step of compressing the cancellous bone when the crystalline skin expands.  
     
     
         14 . The method of  claim 2 , wherein the tissue comprises mobile bone fragments, and wherein the method further comprises the step of reducing the mobile bone fragments when the crystalline skin expands.  
     
     
         15 . The method of  claim 2 , wherein the tissue comprises a collapsed vertebral body, and wherein the method further comprises the step of increasing the height of the collapsed vertebral body when the crystalline skin expands.  
     
     
         16 . The method of  claim 1 , wherein at least a portion of the first thermoplastic material is partially crystallized when the first thermoplastic material is at the second condition.  
     
     
         17 . The method of  claim 1 , wherein the step of introducing the first thermoplastic material into the tissue comprises injecting the first thermoplastic material into the tissue.  
     
     
         18 . The method of  claim 1 , wherein the introduction of the second material into the tissue comprises injecting the second material into the tissue.  
     
     
         19 . The method of  claim 1 , further comprising the step of increasing the temperature of at least a portion of the tissue prior to introducing the first thermoplastic material into the tissue.  
     
     
         20 . The method of  claim 1 , further comprising the step of decreasing the temperature of at least a portion of the tissue prior to introducing the first thermoplastic material into the tissue.  
     
     
         21 . The method of  claim 1 , wherein the step of treating the first thermoplastic material comprises inserting a cooling device into the first thermoplastic material.  
     
     
         22 . The method of  claim 1 , wherein introduction of the second material occurs when the temperature of the second material is higher than the temperature of the first thermoplastic material.  
     
     
         23 . The method of  claim 1 , wherein the temperature of the first thermoplastic material at the first condition is at or above the melting point of the first thermoplastic material, and wherein the temperature of the first thermoplastic material at the second condition is below the melting point of the first thermoplastic material.  
     
     
         24 . The method of  claim 1 , wherein the second material is introduced into the tissue in a molten state.  
     
     
         25 . The method of  claim 1 , further comprising the step of irradiating the first thermoplastic material prior to introducing the first thermoplastic material into the tissue.  
     
     
         26 . The method of  claim 1 , wherein the treating step further comprises allowing the first thermoplastic material to achieve the second condition by exposure to ambient conditions in the tissue.  
     
     
         27 . The method of  claim 1 , wherein the first thermoplastic material and the second material are the same material and the treating step further comprises interrupting the introduction of the first thermoplastic material to allow the first thermoplastic material to achieve the second condition by exposure to ambient conditions in the tissue before the introduction of the second material.  
     
     
         28 . The method of  claim 1 , further comprising the step of exposing the first thermoplastic material to gamma radiation to induce a shape memory characteristic on the first thermoplastic material.  
     
     
         29 . The method of  claim 1 , further comprising the step of introducing at least a third material into the tissue.  
     
     
         30 . The method of  claim 1 , further comprising the step of cooling the first thermoplastic material and the second material after the second material is introduced into the tissue.  
     
     
         31 . The method of  claim 1 , wherein the step of introducing into the tissue a first thermoplastic material comprises introducing the first thermoplastic material into an annulus defined by the tissue.  
     
     
         32 . The method of  claim 1 , wherein at least one of either the first thermoplastic material or the second material comprises an at least partially crystalline polymer.  
     
     
         33 . The method of  claim 1 , wherein at least one of either the first thermoplastic material or the second material comprises a substantially crystalline polymer.  
     
     
         34 . The method of  claim 1 , wherein at least a portion of the first thermoplastic material surrounds at least a portion of the second material.  
     
     
         35 . The method of  claim 1 , wherein the step of introducing the second material into the tissue comprises injecting at least a portion of the second material into the first thermoplastic material.  
     
     
         36 . The method of  claim 1 , wherein at least a portion of the first thermoplastic material is in a semi-solid state when the first thermoplastic material is at the second condition, and wherein the step of introducing the second material into the tissue comprises injecting the second material into the first thermoplastic material.  
     
     
         37 . The method of  claim 1 , wherein the second material comprises osteosynthesis hardware.  
     
     
         38 . The method of  claim 1 , wherein the first thermoplastic material has a rate of crystallization that is adjusted by combining the first thermoplastic material with a substance having a radiodensity that is greater than the radiodensity of the first thermoplastic material.  
     
     
         39 . The method of  claim 38 , wherein the substance comprises at least one of a calcium compound, barium sulfate, strontium carbonate, a zirconium compound, a magnesium compound, titanium oxides and compounds, and combinations thereof.  
     
     
         40 . The method of  claim 1 , wherein prior to introducing the first thermoplastic material into the tissue, the method further comprises increasing the degree of discontinuity in the structure of the first thermoplastic material to adjust the rate of crystallization of the first thermoplastic material.  
     
     
         41 . The method of  claim 40 , wherein the step of increasing the degree of discontinuity in the structure of the first thermoplastic material comprises combining the first thermoplastic material with a radiopacifier.  
     
     
         42 . A method of fracture reduction in a tissue comprising: 
 exposing to gamma radiation a mass of polycaprolactone characterized by a first shape;    heating the mass of irradiated polycaprolactone to a temperature above its melting temperature;    introducing the heated mass of polycaprolactone into a tissue annulus in a shape deformed from the first shape; and    allowing the mass of polycaprolactone to return to a shape that approaches the first shape.    
     
     
         43 . The method of  claim 42 , wherein the gamma radiation comprises gamma radiation in the range of about 15 kGy to about 50 kGy.  
     
     
         44 . The method of  claim 42 , wherein allowing the mass of polycaprolactone to return to a shape that approaches the first shape comprises cooling the mass of polycaprolactone.  
     
     
         45 . The method of  claim 42 , wherein allowing the mass of polycaprolactone to return to a shape that approaches the first shape comprises allowing the mass of polycaprolactone to cool.  
     
     
         46 . The method of  claim 42 , wherein the first shape comprises a substantially tubular configuration having a first diameter and wherein heating the mass of irradiated polycaprolactone above its melting temperature permits the introduction of the mass into an interior aperture of a cannulated device, the interior aperture having a diameter that is smaller than the first diameter.  
     
     
         47 . A method for augmenting a tissue comprising the steps of: 
 adjusting a rate of crystallization of a thermoplastic material by combining the thermoplastic material with a substance having a radiodensity that is greater than the radiodensity of the thermoplastic material;    introducing into the tissue the adjusted thermoplastic material at a first condition; and    treating the thermoplastic material to achieve a second condition that includes an at least partially crystalline skin.    
     
     
         48 . The method of  claim 47  wherein the thermoplastic material is at least partially comprised of polycaprolactone.

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