Thermo-Chemically Activated Implantable Apparatus and Method
The present invention provides an implantable device, a portion of which is formed of a material which is a combination of copolymers PCLM-12 and SMC-7, and nucleating agent A-6. The implantable device may be an intramedullary bone fixation device. The implantable device may have a body with a composite portion including a thermo-chemically activated matrix formed from the copolymer material, and a support structure formed from a second material. The body may be deformable at a first thermo-chemical state and hardened at a second thermo-chemical state. The implantable device may be heated to reach the deformable first thermo-chemical state, deformed, inserted into the intramedullary canal of a fractured bone, and cooled to reach the hardened second thermo-chemical state, providing rigid support during healing of the fractures.
1 . A device configured to be implantable in a mammal, the implantable device comprising:
a body, at least a portion of which is formed of a material comprising:
a percentage by weight ranging from about 95% to about 99.9% of a blend, the blend comprising a percentage by weight ranging from about 30% to about 70% of PCLM-12 and a percentage by weight ranging from about 30% to about 70% of SMC-7; and
a percentage by weight ranging from about 0.1% to about 5% of A-6.
2 . The device of claim 1 , wherein the device comprises an intramedullary bone fixation device, wherein the body comprises an elongated shape.
3 . The device of claim 1 , wherein the body is thermo-chemically activated.
4 . The device of claim 1 , wherein the body is configured to be deformable at a first thermo-chemical state and hardened at a second thermo-chemical state.
5 . The device of claim 1 , wherein the body comprises a composite portion, the composite portion comprising the material and a support structure.
6 . The device of claim 1 , wherein the material comprises:
98% by weight of the blend, wherein the blend comprises 45% by weight of PCLM-12 and 55% by weight of SMC-7;
and 2% by weight of A-6.
7 . A composite device configured to be implantable in a mammal, the composite device comprising:
a thermo-chemically activated thermoplastic matrix material, comprising a blend of PCLM-12, SMC-7, and A-6; and
a support structure comprising a second material coupled to the thermo-chemically activated thermoplastic matrix material to structurally support the thermo-chemically activated thermoplastic matrix material.
8 . The composite device of claim 7 , wherein the thermo-chemically activated thermoplastic matrix material comprises:
30 to 70% by weight of PCLM-12; and
30 to 70% by weight of SMC-7.
9 . The composite device of claim 7 , wherein the thermo-chemically activated thermoplastic matrix material comprises:
98% by weight of a blend of 45% by weight of PCLM-12 and 55% by weight of SMC-7; and
2% by weight of A-6.
10 . The composite device of claim 7 , wherein the second material is not identical to the thermo-chemically activated thermoplastic matrix material, wherein the second material comprises a biocompatible material selected from the group consisting of: metals, metal alloys, ceramics, and polymers.
11 . The composite device of claim 7 , wherein the thermo-chemically activated thermoplastic matrix material is configured to be deformable at a first thermo-chemical state and hard at a second thermo-chemical state.
12 . The composite device of claim 7 , wherein the support structure is embedded in the thermo-chemically activated thermoplastic matrix material.
13 . A composite bone fixation device comprising:
a body formed at least partially of a thermo-chemically activated thermoplastic matrix material, the thermo-chemically activated thermoplastic matrix material comprising a blend of PCLM-12, SMC-7, and A-6;
wherein the body comprises an elongated shape selected to permit implantation of the device in an intramedullary canal of a bone.
14 . The composite bone fixation device of claim 13 , wherein the thermo-chemically activated thermoplastic matrix material comprises:
30 to 70% by weight of PCLM-12; and
30 to 70% by weight of SMC-7.
15 . The composite bone fixation device of claim 13 , wherein the thermo-chemically activated thermoplastic matrix material comprises:
98% by weight of a blend of 45% by weight of PCLM-12 and 55% by weight of SMC-7; and
2% by weight of A-6.
16 . The composite bone fixation device of claim 13 , further comprising:
a support structure having an elongated shape, wherein the support structure is configured to be embedded in the thermo-chemically activated matrix material to structurally support the thermo-chemically activated matrix material.
17 . A device configured to be implantable in a mammal, the implantable device comprising:
a first thermo-chemically activated composite portion comprising a thermo-chemically activated thermoplastic matrix material and a support structure, the thermo-chemically activated thermoplastic matrix material comprising a blend of PCLM-12, SMC-7, and A-6; and
a second non-composite portion.
18 . The composite device of claim 17 , wherein the first thermo-chemically activated composite portion is configured to be deformable at a first thermo-chemical state and hard at a second thermo-chemical state.
19 . The implantable device of claim 17 , wherein the second non-composite portion comprises a material selected from the group consisting of: metals, metal alloys, ceramics, and polymers.
20 . The implantable device of claim 17 , further comprising a third non-composite portion comprising the thermo-chemically activated thermoplastic matrix material.
21 . The composite bone fixation device of claim 17 , wherein the thermo-chemically activated thermoplastic matrix material comprises:
30 to 70% by weight of PCLM-12; and
30 to 70% by weight of SMC-7.
22 . The composite bone fixation device of claim 17 , wherein the thermo-chemically activated thermoplastic matrix material comprises:
98% by weight of a blend of 45% by weight of PCLM-12 and 55% by weight of SMC-7; and
2% by weight of A-6.
23 . A method of stabilizing a fractured bone, comprising:
implanting a device in the intramedullary canal of the fractured bone, the device comprising:
a body, at least a portion of which is formed of a material comprising:
a percentage by weight ranging from about 95% to about 99.9% of a blend, the blend comprising a percentage by weight ranging from about 30% to about 70% of PCLM-12 and a percentage by weight ranging from about 30% to about 70% of SMC-7; and
a percentage by weight ranging from about 0.1% to about 5% of A-6.
24 . The method of claim 23 , wherein the material is thermo-chemically activated, wherein the body is configured to be deformable at a first thermo-chemical state and hard at a second thermo-chemical state.
25 . The method of claim 24 , further comprising:
increasing a temperature of the material to transform the body from the second thermo-chemical state to the first thermo-chemical state;
deforming the body, and
decreasing a temperature of the material to transform the body from the first thermo-chemical state to the second thermo-chemical state.
26 . The method of claim 23 , wherein the body further comprises a composite portion, the composite portion comprising the material and a support structure comprising a second material.
27 . The method of claim 23 , wherein the material comprises:
98% by weight of the blend, wherein the blend comprises 45% by weight of PCLM-12 and 55% by weight of SMC-7;
and 2% by weight of A-6.