US6443988B2 — Mold apparatus and kit for in situ tissue repair

Claim 1

Independent Claim 291 words

A method for forming a prosthesis in situ comprising providing an apparatus comprising an implantable, expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of flowable biomaterial, and a) providing the implantable mold apparatus, having the conduit connecting the cavity to a biomaterial source comprising a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure, wherein the composition parts comprise: (1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts, wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material, b) inserting the mold apparatus into a tissue site, c) mixing the composition parts in order to initiate cure and delivering a quantity of the curing composition through the conduit in order to fill and expand the cavity, wherein upon mixing the biomaterial sets within about 3 to about 15 minutes and when cured exhibits a tensile strength of between about 6,000 psi and about 10,000 psi when measured in the dry state according to ASTM test method D412, d) permitting the biomaterial composition to completely cure, and e) employing the molded biomaterial in situ as a prosthesis at the tissue site, wherein the apparatus further comprises an air passageway positioned to vent the balloon in the course of filling with biomaterial.

Claim 2

Independent Claim 291 words

A method for forming a prosthesis in situ comprising providing an apparatus comprising an implantable, expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of flowable biomaterial, and a) providing the implantable mold apparatus, having the conduit connecting the cavity to a biomaterial source comprising a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure, wherein the composition parts comprise: (1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts, wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material, b) inserting the mold apparatus into a tissue site, c) mixing the composition parts in order to initiate cure and delivering a quantity of the curing composition through the conduit in order to fill and expand the cavity, wherein upon mixing the biomaterial sets within about 3 to about 15 minutes and when cured exhibits a tensile strength of between about 6,000 psi and about 10,000 psi when measured in the dry state according to ASTM test method D412, d) permitting the biomaterial composition to completely cure, and e) employing the molded biomaterial in situ as a prosthesis at the tissue site, wherein the apparatus further comprises an air passageway positioned to vent the balloon in the course of filling with biomaterial.

Claim 3

Dependent Claim 38 words

A method according to claim 1 , wherein the apparatus is adapted for use by minimally invasive means and the cavity is a provided in the form of an inflatable balloon for use in preparing an intact prosthesis.

Claim 4

Dependent Claim 18 words

A method according to claim 1 wherein the balloon is adapted for use in repairing an intervertebral disc.

Claim 5

Dependent Claim 19 words

A method according to claim 1 further comprising distal control valves for the biomaterial conduit and air passageway, respectively.

Claim 6

Dependent Claim 43 words

A method according to claim 1 wherein the apparatus is provided in the form of a balloon, collapsed or rolled within a delivery sheath in a manner that permits the balloon to be delivered from the sheath and positioned within the tissue site.

Claim 7

Dependent Claim 35 words

A method according to claim 1 wherein the apparatus is provided in the form of a balloon adapted to be collapsed by the application of vacuum in the course of delivery to the tissue site.

Claim 8

Dependent Claim 28 words

A method according to claim 1 comprising a balloon formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas.

Claim 9

Dependent Claim 23 words

A method according to claim 7 wherein the material has a thickness of on the order of 0.01 cm to about 0.05 cm.

Claim 10

Dependent Claim 20 words

A method according to claim 8 wherein the thickness is on the order of 0.02 cm to about 0.03 cm.

Claim 11

Dependent Claim 23 words

A method according to claim 1 wherein the apparatus is provided in the form of a balloon having a reinforcing material incorporated therein.

Claim 12

Dependent Claim 24 words

A method according to claim 10 wherein the reinforcing material is selected from the group consisting of meshes formed of natural or synthetic materials.

Claim 13

Dependent Claim 19 words

A method according to claim 1 , wherein the apparatus is adapted for use in repairing an intervertebral disc.

Claim 14

Dependent Claim 43 words

A method according to claim 12 wherein the apparatus is provided in the form of a balloon, collapsed or rolled within a delivery sheath in a manner that permits the balloon to be delivered from the sheath and positioned within the tissue site.

Claim 15

Dependent Claim 28 words

A method according to claim 13 comprising a balloon formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas.

Claim 16

Dependent Claim 23 words

A method according to claim 14 wherein the material has a thickness of on the order of 0.01 cm to about 0.05 cm.

Claim 17

Dependent Claim 23 words

A method according to claim 15 wherein the apparatus is provided in the form of a balloon having a reinforcing material incorporated therein.

Claim 18

Dependent Claim 45 words

A method according to claim 14 wherein the mold apparatus is between about cm to about 3 cm in its longest dimension, about 1.5 cm to about 2.5 cm in width, and about 0.5 cm to about 1.5 cm in thickness, once filled with biomaterial.

Claim 19

Dependent Claim 313 words

A surgical kit comprising a biomaterial source and a mold apparatus for forming a prosthesis in situ, the apparatus comprising an implantable, expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of flowable biomaterial, wherein the mold apparatus is adapted for use in a method that comprises the steps of: a) providing the implantable mold apparatus, having the conduit connecting the cavity to a biomaterial source comprising a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure, wherein the composition parts comprise: (1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts, wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material, b) inserting the mold apparatus into a tissue site, c) mixing the composition parts in order to initiate cure and delivering a quantity of the curing composition through the conduit in order to fill and expand the cavity, wherein upon mixing the biomaterial sets within about 3 to about 15 minutes and when cured exhibits a tensile strength of between about 6,000 psi and about 10,000 psi when measured in the dry state according to ASTM test method D412. d) permitting the biomaterial composition to completely cure, and e) employing the molded biomaterial in situ as a prosthesis at the tissue site wherein the apparatus further comprises an air passageway positioned to vent the balloon in the course of filling with biomaterial.

Claim 20

Dependent Claim 313 words

A surgical kit comprising a biomaterial source and a mold apparatus for forming a prosthesis in situ, the apparatus comprising an implantable, expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of flowable biomaterial, wherein the mold apparatus is adapted for use in a method that comprises the steps of: a) providing the implantable mold apparatus, having the conduit connecting the cavity to a biomaterial source comprising a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure, wherein the composition parts comprise: (1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts, wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material, b) inserting the mold apparatus into a tissue site, c) mixing the composition parts in order to initiate cure and delivering a quantity of the curing composition through the conduit in order to fill and expand the cavity, wherein upon mixing the biomaterial sets within about 3 to about 15 minutes and when cured exhibits a tensile strength of between about 6,000 psi and about 10,000 psi when measured in the dry state according to ASTM test method D412. d) permitting the biomaterial composition to completely cure, and e) employing the molded biomaterial in situ as a prosthesis at the tissue site wherein the apparatus further comprises an air passageway positioned to vent the balloon in the course of filling with biomaterial.

Claim 21

Dependent Claim 19 words

A kit according to claim 18 wherein the curable polyurethane composition further comprises one or more reactive hydrophobic additives.

Claim 22

Dependent Claim 27 words

A kit according to claim 19 wherein the composition provides improved cure characteristics and cured properties as compared to a comparable composition lacking the reactive hydrophobic additive.

Claim 23

Dependent Claim 71 words

A kit according to claim 19 wherein the hydrophobic polymer additive is present at a concentration of between about 1% and about 50% by weight, and is selected from the group consisting of hydroxyl- or amine-terminated compounds selected from the group consisting of poybutadiene, polyisoprene, polyisobutylene, silicones, polyethylenepropylenediene, copolymers of butadiene with acryolnitrile, copolymers of butadiene with styrene, copolymers of isoprene with acrylonitrile, copolymers of isoprene with styrene, and mixtures thereof.

Claim 24

Dependent Claim 27 words

A kit according to claim 20 wherein the improved cure characteristics include a significant reduction in the appearance of bubbles when cured in the presence of moisture.

Claim 25

Dependent Claim 26 words

A kit according to claim 18 wherein the biomaterial provides an induction period of about thirty seconds to two minutes upon mixing of the composition parts.

Claim 26

Dependent Claim 21 words

A kit according to claim 18 wherein the cured biomaterial provides a hardness of about 60 Shore to about 95 Shore.

Claim 27

Dependent Claim 87 words

A kit according to claim 18 wherein the biomaterial source comprises a curable polyurethane biomaterial composition comprising a plurality of parties adapted to be stably stored and mixed at the time of use in order to provide a flowable composition and to initiate cure, wherein the composition parts comprise: (1) a quasi-prepolymer component comprising the reaction product of one or more polyols and one or more isocyanates, and (2) a curative component comprising one or more polyols, one or more chain extenders, and one or more catalysts.

Claim 28

Dependent Claim 56 words

A kit according to claim 25 wherein the polyol component is present at a concentration of between about 2% and about 10%, by weight, based on the weight of the composition, and is selected from the group consisting of linear or branched polyols with polyether backbones of polyoxyethylene, polyoxypropylene, and polytetramethylene oxide (polyoxytetramethylene), and copolymers thereof.

Claim 29

Dependent Claim 25 words

A kit according to claim 26 wherein the polyol comprises one or more polytetramethylene oxides having molecular weights in the range of 250 to 2900.

Claim 30

Dependent Claim 36 words

A kit according to claim 25 wherein the isocyanate is present in excess in the prepolymer component and comprises an aromatic (poly)isocyanate selected from the group consisting of 2,2′-, 2,4′-, and 4,4′-diphenylmethanediisocyanate (MDI), and combinations thereof.

Claim 31

Dependent Claim 31 words

A kit according to claim 18 the mold apparatus comprises a balloon formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas.

Claim 32

Dependent Claim 23 words

A kit according to claim 29 wherein the material has a thickness of on the order of 0.01 cm to about 0.05 cm.

Claim 33

Dependent Claim 23 words

A kit according to claim 18 wherein the apparatus is provided in the form of a balloon having a reinforcing material incorporated therein.

Claim 34

Dependent Claim 20 words

A mold apparatus according to claim 18 , wherein the apparatus is adapted for use in repairing an intervertebral disc.

Claim 35

Dependent Claim 43 words

A kit according to claim 32 wherein the apparatus is provided in the form of a balloon, collapsed or rolled within a delivery sheath in a manner that permits the balloon to be delivered from the sheath and positioned within the tissue site.

Claim 36

Dependent Claim 28 words

A kit according to claim 32 comprising a balloon formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas.

Claim 37

Dependent Claim 23 words

A kit according to claim 34 wherein the material has a thickness of on the order of 0.01 cm to about 0.05 cm.

Claim 38

Dependent Claim 23 words

A kit according to claim 18 wherein the apparatus is provided in the form of a balloon having a reinforcing material incorporated therein.

Claim 39

Dependent Claim 45 words

A kit according to claim 18 wherein the mold apparatus is between about cm to about 3 cm in its longest dimension, about 1.5 cm to about 2.5 cm in width, and about 0.5 cm to about 1.5 cm in thickness, once filled with biomaterial.

Claim 40

Dependent Claim 185 words

A kit according to claim 25 wherein: a) the mold apparatus comprises a balloon, collapsed or rolled within a delivery sheath in a manner that permits the balloon to be delivered from the sheath and positioned within the tissue site, b) the balloon is formed from an extendible material selected from the group consisting of castable thermoplastic polyurethanes and castable linear urethane ureas, c) the material has a thickness of on the order of 0.01 cm to about 0.05 cm, and d) within the prepolymer of the biomaterial, the polyether component is present at a concentration of between about 2% and about 10%, by weight, based on the weight of the composition, and is selected from the group consisting of linear or branched polyols with polyether backbones of polyoxyethylene, polyoxypropylene, and polytetramethylene oxide (polyoxytetramethylene), and copolymers thereof, the polyol comprises one or more polytetramethylene oxides having molecular weights in the range of 250 to 2900, and the isocyanate is present in excess in the prepolymer component and comprises an aromatic (poly)isocyanate selected from the group consisting of 2,2′-, 2,4′-, and 4,4′-diphenylmethanediisocyanate (MDI), and combinations thereof.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2005-09-02	2006-03-04	2006-09-03	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2009-09-02	2010-03-04	2010-09-03	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2013-09-02	2014-03-04	2014-09-03	$7700.00	Window Closed / Lapsed

Mold apparatus and kit for in situ tissue repair

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