US20010004710A1 — Mold apparatus and kit for in situ tissue repair

Claim 1

Independent Claim 90 words

1 . A method for repairing a tissue site, the method comprising the steps of: (a) providing a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be mixed at the time of use in order to provide a flowable composition and to initiate cure, (b) mixing the composition parts in order to initiate cure and employing minimally invasive means to deliver a quantity of the curing composition to the tissue site, and (c) completely curing the delivered composition to provide a permanent repair of the tissue site.

Claim 2

Dependent Claim 90 words

1 . A method for repairing a tissue site, the method comprising the steps of: (a) providing a curable polyurethane biomaterial composition comprising a plurality of parts adapted to be mixed at the time of use in order to provide a flowable composition and to initiate cure, (b) mixing the composition parts in order to initiate cure and employing minimally invasive means to deliver a quantity of the curing composition to the tissue site, and (c) completely curing the delivered composition to provide a permanent repair of the tissue site.

Claim 3

Dependent Claim 97 words

2 . A method according to claim 1 wherein the composition parts comprise: (1) a quasi-prepolymer component comprising the reaction product of one or more polyether polyols, one or more isocyanates, and one or more reactive hydrophobic additives, and (2) a curative component comprising one or more polyether 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 by minimally invasive means and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material.

Claim 4

Dependent Claim 30 words

3 . A method according to claim 2 wherein the composition provides improved cure characteristics and cured properties as compared to a comparable composition lacking the reactive hydrophobic additive component.

Claim 5

Dependent Claim 29 words

4 . A method according to claim 3 wherein the improved cure characteristics include a significant reduction in the appearance of bubbles when cured in the presence of moisture.

Claim 6

Dependent Claim 37 words

5 . A method according to claim 1 wherein the curing composition provides an induction period of about thirty seconds to two minutes and a set time of about 3 minutes to about 15 minutes following mixing.

Claim 7

Dependent Claim 28 words

6 . A method according to claim 1 wherein the method is used to repair an orthopedic joint selected from the group consisting of diarthroidal and amphiarthroidal joints.

Claim 8

Dependent Claim 24 words

7 . A method according to claim 6 wherein the amphiarthroidal joints are selected from the group consisting of synphysoidal joints and syndemoidal joints.

Claim 9

Dependent Claim 15 words

8 . A method according to claim 7 wherein the synphysiodal joints are intervertebral joints.

Claim 10

Dependent Claim 21 words

9 . A method according to claim 6 wherein the method is performed using endoscopic/arthroscopic surgical instrumentation and under fiberoptic visualization.

Claim 11

Dependent Claim 24 words

10 . A method according to claim 9 wherein the instrumentation comprises a static mixer and delivery cannula to mix and deliver the composition.

Claim 12

Dependent Claim 118 words

11 . A curable polyurethane composition comprising a plurality of parts capable of being mixed at the time of use in order to provide a flowable composition and to initiate cure, the parts comprising: (1) a quasi-prepolymer component comprising the reaction product of one or more polyether polyols, one or more isocyanates, and one or more reactive hydrophobic additives, and (2) a curative component comprising one or more polyether polyols, one or more chain extenders, and one or more catalysts, wherein the composition is sufficiently flowable to permit it to be delivered to a tissue site by minimally invasive means and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material.

Claim 13

Dependent Claim 118 words

11 . A curable polyurethane composition comprising a plurality of parts capable of being mixed at the time of use in order to provide a flowable composition and to initiate cure, the parts comprising: (1) a quasi-prepolymer component comprising the reaction product of one or more polyether polyols, one or more isocyanates, and one or more reactive hydrophobic additives, and (2) a curative component comprising one or more polyether polyols, one or more chain extenders, and one or more catalysts, wherein the composition is sufficiently flowable to permit it to be delivered to a tissue site by minimally invasive means and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material.

Claim 14

Dependent Claim 29 words

12 . A composition according to claim 11 wherein the composition provides improved cure characteristics and cured properties as compared to a comparable composition lacking the reactive hydrophobic additive.

Claim 15

Dependent Claim 73 words

13 . A composition according to claim 12 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 16

Dependent Claim 29 words

14 . A composition according to claim 12 wherein the improved cure characteristics include a significant reduction in the appearance of bubbles when cured in the presence of moisture.

Claim 17

Dependent Claim 37 words

15 . A composition according to claim 11 wherein the curing composition provides an induction period of about thirty seconds to two minutes and a set time of about 3 minutes to about 15 minutes following mixing.

Claim 18

Dependent Claim 42 words

16 . A composition according to claim 12 wherein the improved cured properties include a hardness of about 60 Shore to about 95 Shore, and a tensile strength (measured in the dry stage) of between about 6,000 psi and about 10,000 psi.

Claim 19

Dependent Claim 61 words

17 . A composition according to claim 13 wherein, within the prepolymer, 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.

Claim 20

Dependent Claim 27 words

18 . A composition according to claim 17 wherein the polyol comprises one or more polytetramethylene oxides having molecular weights in the range of 250 to 2900.

Claim 21

Dependent Claim 39 words

19 . A composition according to claim 13 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 22

Dependent Claim 30 words

20 . A kit comprising a plurality of compositions according to claim 11 , the compositions providing different hardnesses in their cured form, for use in preparing a heterogeneous implant.

Claim 23

Dependent Claim 103 words

21 . A method according to claim 1 , wherein the method comprises the further steps of: a) providing an implantable mold apparatus comprising an expandable cavity adapted to receive and contain the flowable biomaterial composition and a conduit adapted to connect the cavity to a source of curable, flowable biomaterial composition, b) inserting the mold apparatus to the tissue site, c) mixing and delivering biomaterial composition to the mold in order to fill the cavity to a desired extent, d) permitting the biomaterial composition to completely cure, and e) employing the molded biomaterial in situ as a prosthesis at the tissue site.

Claim 24

Dependent Claim 31 words

22 . A method according to claim 21 wherein the steps of inserting the mold apparatus, delivering the biomaterial composition, and curing the composition are each performed by minimally invasive means.

Claim 25

Dependent Claim 30 words

23 . A method according to claim 21 wherein the cavity is provided in the form of an inflatable balloon and the method is used to prepare an intact prosthesis.

Claim 26

Dependent Claim 18 words

24 . A method according to claim 23 wherein the method is used to repair an intervertebral disc.

Claim 27

Dependent Claim 17 words

25 . A method according to claim 23 wherein the method is used to resurface a knee.

Claim 28

Dependent Claim 26 words

26 . A method according to claim 21 wherein the cavity is provided in tubular form and the method is used to prepare a tubular implant.

Claim 29

Dependent Claim 28 words

27 . A method according to claim 26 wherein the tubular implant is used to form an implant selected from the group consisting of stents, shunts and grafts.

Claim 30

Dependent Claim 22 words

28 . A method according to claim 27 wherein the tubular implant comprises a prosthetic implant for repairing an abdominal aortic aneurysm.

Claim 31

Dependent Claim 96 words

29 . A method according to claim 21 wherein the composition parts comprise: (1) a quasi-prepolymer component comprising the reaction product of one or more polyether polyols, one or more isocyanates, and one or more reactive hydrophobic additives, and (2) a curative component comprising one or more polyether polyols, one or more chain extenders, one or more catalysts, wherein the composition is sufficiently flowable to permit it to be delivered to the tissue site by minimally invasive means and there undergo complete cure in situ under physiologically acceptable conditions in order to provide a biocompatible material.

Claim 32

Dependent Claim 37 words

30 . A method according to claim 29 wherein the curing composition provides an induction period of about thirty seconds to two minutes and a set time of about 3 minutes to about 15 minutes following mixing.

Claim 33

Dependent Claim 42 words

31 . 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.

Claim 34

Dependent Claim 42 words

31 . 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.

Claim 35

Dependent Claim 40 words

32 . An apparatus according to claim 31 , 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 36

Dependent Claim 20 words

33 . An apparatus according to claim 32 wherein the balloon is adapted for use in repairing an intervertebral disc.

Claim 37

Dependent Claim 28 words

34 . An apparatus according to claim 33 wherein the apparatus further comprises an air passageway positioned to vent the balloon in the course of filling with biomaterial.

Claim 38

Dependent Claim 21 words

35 . An apparatus according to claim 33 further comprising distal control valves for the biomaterial conduit and air passageway, respectively.

Claim 39

Dependent Claim 29 words

36 . An apparatus according to claim 32 wherein the balloon provides a knee prosthesis and is adapted to be permanently positioned and filled in apposition to subchondral bone.

Claim 40

Dependent Claim 41 words

37 . An apparatus according to claim 36 wherein the balloon comprises a surface for contact with subchondral bone, the surface being provided with one or more foot pads adapted to be implanted into corresponding anchor points drilled within subchondral bone.

Claim 41

Dependent Claim 40 words

38 . An apparatus according to claim 36 wherein the balloon comprises a surface for contact with subchondral bone, the surface being fenestrated in order to permit the passage of biomaterial from the cavity to contact with the subchondral bone.

Claim 42

Dependent Claim 37 words

39 . A surgical kit comprising an apparatus according to claim 37 in combination with a template for use in drilling anchor points in subchondral bone at positions corresponding to those of foot pads on the apparatus.

Claim 43

Dependent Claim 61 words

40 . A surgical kit for use in preparing a prosthesis in vivo, the kit comprising (a) an implantable mold apparatus comprising an expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of curable, flowable biomaterial and (b) a supply of a curable, flowable polyurethane biomaterial composition.

Claim 44

Dependent Claim 61 words

40 . A surgical kit for use in preparing a prosthesis in vivo, the kit comprising (a) an implantable mold apparatus comprising an expandable cavity adapted to receive and contain a flowable, curable biomaterial, and a removable conduit adapted to connect the cavity to a source of curable, flowable biomaterial and (b) a supply of a curable, flowable polyurethane biomaterial composition.

Claim 45

Dependent Claim 54 words

41 . A prosthesis for repairing an intervertebral disc, the prosthesis comprising an expanded mold cavity containing a cured, biocompatible, polyurethane biomaterial composition, the prosthesis providing a hardness of about 60 Shore to about 95 Shore, and a tensile strength (measured in the dry stage) of between about 6,000 psi and about 10,000 psi.

Claim 46

Dependent Claim 54 words

41 . A prosthesis for repairing an intervertebral disc, the prosthesis comprising an expanded mold cavity containing a cured, biocompatible, polyurethane biomaterial composition, the prosthesis providing a hardness of about 60 Shore to about 95 Shore, and a tensile strength (measured in the dry stage) of between about 6,000 psi and about 10,000 psi.

Claim 47

Dependent Claim 50 words

42 . A prosthesis for repairing the surface of a knee joint, the prosthesis comprising a cured, biocompatible, polyurethane biomaterial composition providing a hardness of about 60 Shore to about 95 Shore, and a tensile strength (measured in the dry stage) of between about 6,000 psi and about 10,000 psi.

Claim 48

Dependent Claim 50 words

42 . A prosthesis for repairing the surface of a knee joint, the prosthesis comprising a cured, biocompatible, polyurethane biomaterial composition providing a hardness of about 60 Shore to about 95 Shore, and a tensile strength (measured in the dry stage) of between about 6,000 psi and about 10,000 psi.

Claim 49

Dependent Claim 31 words

43 . A prosthesis according to claim 42 wherein the prosthesis is heterogeneous, comprising a plurality of cured polyurethane compositions, in order to provide layers having one or more different properties.

Claim 50

Dependent Claim 32 words

44 . A prosthesis according to claim 42 wherein the cured biomaterial is provided within a mold cavity and the prosthesis is adapted to be permanently positioned in apposition to subchondral bone.

Claim 51

Dependent Claim 50 words

45 . A prosthesis according to claim 43 wherein the mold cavity is provided in the form of a balloon comprising a surface for contact with subchondral bone, the surface being provided with one or more foot pads adapted to be implanted into corresponding anchor points drilled within subchondral bone.

Mold apparatus and kit for in situ tissue repair

Abstract

Inventors

Bibliographic Details

Claims Analysis

References Cited (Backward Citations)

USPTO Annuity & Maintenance Windows

Assigned Categories & Tags

Assign Category Tag