Hydrogel arthroplasty device
First Claim
1. An arthroplasty device, comprising:
- an interpenetrating polymer network hydrogel that is strain-hardened by swelling and is adapted to be held in place in a mammalian joint by conforming to a naturally or artificially prepared geometry of a bone in said mammalian joint, wherein said strain-hardened interpenetrating polymer network hydrogel is characterized by having;
(a) a first network, wherein said first network is a non-silicone network of preformed hydrophilic non-ionic telechelic macromonomers chemically cross-linked by polymerization of its end-groups;
(b) a second network, wherein said second network is a non-silicone polymer network of ionizable monomers, wherein said second network has been polymerized and cross-linked in the presence of said first network and has formed physical entanglements with said first network forming an interpenetrating polymer network hydrogel, and wherein the degree of chemical cross-linking in said second network is less than the degree of chemical cross-linking in said first network; and
(c) an aqueous salt solution having a neutral pH, wherein said aqueous salt solution has ionized and swollen said second network in said interpenetrating polymer network hydrogel, wherein said swelling of said second network is constrained by said first network, yielding the strain-hardened interpenetrating polymer network hydrogel with an initial tensile elastic modulus which is larger than the initial tensile elastic modulus of either (i) said first network of hydrophilic non-ionic telechelic macromonomers as in 1(a) swollen in pure water or in said aqueous salt solution, said second network of ionized monomers as in 1(b) swollen in pure water or in said aqueous salt solution, or (iii) or said interpenetrating polymer network hydrogel formed by the combination of said first and second network as in 1(a) and 1(b) swollen in pure water,wherein said device is characterized by having a bone-interfacing region and a bearing region opposite to said bone-interfacing region, wherein said bone-interfacing region conforms and fixates to said naturally or artificially prepared geometry of said bone in said mammalian joint.
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Accused Products
Abstract
An arthroplasty device is provided having an interpenetrating polymer network (IPN) hydrogel that is strain-hardened by swelling and adapted to be held in place in a joint by conforming to a bone geometry. The strain-hardened IPN hydrogel is based on two different networks: (1) a non-silicone network of preformed hydrophilic non-ionic telechelic macromonomers chemically cross-linked by polymerization of its end-groups, and (2) a non-silicone network of ionizable monomers. The second network was polymerized and chemically cross-linked in the presence of the first network and has formed physical cross-links with the first network. Within the IPN, the degree of chemical cross-linking in the second network is less than in the first network. An aqueous salt solution (neutral pH) is used to ionize and swell the second network. The swelling of the second network is constrained by the first network resulting in an increase in effective physical cross-links within the IPN.
188 Citations
45 Claims
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1. An arthroplasty device, comprising:
- an interpenetrating polymer network hydrogel that is strain-hardened by swelling and is adapted to be held in place in a mammalian joint by conforming to a naturally or artificially prepared geometry of a bone in said mammalian joint, wherein said strain-hardened interpenetrating polymer network hydrogel is characterized by having;
(a) a first network, wherein said first network is a non-silicone network of preformed hydrophilic non-ionic telechelic macromonomers chemically cross-linked by polymerization of its end-groups; (b) a second network, wherein said second network is a non-silicone polymer network of ionizable monomers, wherein said second network has been polymerized and cross-linked in the presence of said first network and has formed physical entanglements with said first network forming an interpenetrating polymer network hydrogel, and wherein the degree of chemical cross-linking in said second network is less than the degree of chemical cross-linking in said first network; and (c) an aqueous salt solution having a neutral pH, wherein said aqueous salt solution has ionized and swollen said second network in said interpenetrating polymer network hydrogel, wherein said swelling of said second network is constrained by said first network, yielding the strain-hardened interpenetrating polymer network hydrogel with an initial tensile elastic modulus which is larger than the initial tensile elastic modulus of either (i) said first network of hydrophilic non-ionic telechelic macromonomers as in 1(a) swollen in pure water or in said aqueous salt solution, said second network of ionized monomers as in 1(b) swollen in pure water or in said aqueous salt solution, or (iii) or said interpenetrating polymer network hydrogel formed by the combination of said first and second network as in 1(a) and 1(b) swollen in pure water, wherein said device is characterized by having a bone-interfacing region and a bearing region opposite to said bone-interfacing region, wherein said bone-interfacing region conforms and fixates to said naturally or artificially prepared geometry of said bone in said mammalian joint. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
- an interpenetrating polymer network hydrogel that is strain-hardened by swelling and is adapted to be held in place in a mammalian joint by conforming to a naturally or artificially prepared geometry of a bone in said mammalian joint, wherein said strain-hardened interpenetrating polymer network hydrogel is characterized by having;
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31. A method of making an arthroplasty device, comprising:
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providing an interpenetrating polymer network hydrogel that is strain-hardened by swelling and is adapted to be held in place in a mammalian joint by conforming to a naturally or artificially prepared geometry of a bone in said mammalian joint, wherein said strain-hardened interpenetrating polymer network hydrogel is characterized by the steps of; (a) providing a first network, wherein said first network is a non-silicone network of preformed hydrophilic non-ionic telechelic macromonomers chemically cross-linked by polymerization of its end-groups; (b) providing a second network, wherein said second network is a non-silicone polymer network of ionizable monomers; (c) polymerizing and cross-linking said second network in the presence of said first network, wherein said second network is forming physical entanglements with said first network forming an interpenetrating polymer network hydrogel, and wherein the degree of chemical cross-linking in said second network is less than the degree of chemical cross-linking in said first network; and (d) ionizing and swelling said second network in said interpenetrating polymer network hydrogel with an aqueous salt solution having a neutral pH, wherein said swelling of said second network is constrained by said first network, and wherein said ionizing and swelling yields to a strain-hardened interpenetrating polymer network hydrogel with an initial tensile elastic modulus which is larger than the initial tensile elastic modulus of either (i) said first network of hydrophilic non-ionic telechelic macromonomers as in 31(a) swollen in pure water or in said aqueous salt solution, said second network of ionized monomers as in 31(b) swollen in pure water or in said aqueous salt solution, or (iii) or said interpenetrating polymer network hydrogel formed by the combination of said first and second network as in 31(a) and 31(b) swollen in pure water; and wherein said device is characterized by having a bone-interfacing region and a bearing region opposite to said bone-interfacing region, wherein said bone-interfacing region conforms to said naturally or artificially prepared geometry of said bone in said mammalian joint. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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Specification