Utilization of biocompatible adhesive/sealant materials for securing surgical devices

• US 5,550,172 A
• Filed: 02/07/1995
• Issued: 08/27/1996
• Est. Priority Date: 02/07/1995
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Bregen, Michael F., Cooper, Kevin, Huxel, Shawn T., Rosenman, Daniel C., Regula, Donald W.
• Primary Examiner(s): Michl, Paul R.
• Assistant Examiner(s): DeWitt, LaVonda R.
• Application Number:
  US08/385,015
• Time in Patent Office: 567 Days
• Field of Search: 523/118, 606/76, 606/77, 528/354, 528/363, 524/436, 423/305, 423/308, 423/309, 423/311
• US Class Current: 523/118
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: C08L 35/04 Homopolymers or copolymers of nitriles C08L35/06, C08L35/08 take precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A process for enhancing the security of implantable surgical devices secured to bone tissue comprising implanting in bone tissue a surgical device with a biocompatible adhesive and/or sealant selected from the group consisting of: p1 (a) a material made from monomers of the formula:

CHR.sup.1 ═CX.sup.1 Y.sup.1

wherein X¹ and Y¹ are each strong electron withdrawing groups, and R¹ is hydrogen or, provided that X¹ and Y¹ are both cyano groups, a C₁ -C₄ alkyl group;

(b) a semi-crystalline aliphatic poly(ester) of the formula:

[--0--R.sup.11 --C(0)--].sub.y,

wherein R¹¹ is selected from the group consisting of --CR¹² H--, --(CH₂)₃ --0--, --CH₂ --CH₂ --O--CH₂ --, CR₁₂ H--CH₂, --(CH₂)₄ --, --(CH₂)_z --O--C(O)-- and --(CH₂)_z --C(O)--CH₂ --; R¹² is hydrogen or methyl; z is an integer in the range of from 1 to 7 and y is an integer in the range of from about 10 to about 20,000; and

(c) a slurry of water and a calcium containing compounds with the general formula:

M.sup.2+.sub.10-n N.sup.1+.sub.2n (WO.sub.4.sup.3-).sub.6 mU.sup.2-

where n is an integer from 1 to 10, and m is 2 when x is 1, or m is 1 when x is 2, M and N are alkali or alkaline earth metals; WO₄ is an acid radical and w is phosphorus, vanadium, sulfur, silicon, or is substituted in whole or part with carbonate (CO₃^2-); and U is a halide, hydroxide, or carbonate; provided in an amount effective to increase the amount of force necessary to remove the implanted surgical device. Additionally provided is a surgical device that is at least partially coated with at least one biocompatible adhesive and/or sealant.

Claims

1. A process for enhancing the security of implantable surgical devices secured to bone tissue consisting essentially of securing a surgical device with a biocompatible adhesive and/or sealant selected from the group consisting of:

(a) a bioabsorbable semi-crystalline aliphatic poly(ester) of the formula;

space="preserve" listing-type="equation">[--0--R.sup.11 --C(O)--].sub.Y,

wherein R¹¹ is selected from the group consisting of --CR¹² H--, --(CH₂)₃ --O--, --CH₂ --CH₂ --O--CH₂ --, CR¹² H--CH², --(CH₂)₄ --, --(CH₂)_z --O--C(O)-- and --(CH₂)_z --C(O)--CH₂ --;

R¹² is hydrogen or methyl;

z is an integer in the range of from 1 to 7 and y is an integer in the range of from about 10 to about 20,000; and

(b) a slurry of water and a calcium containing compound with the general formula;

space="preserve" listing-type="equation">M.sup.2 +.sub.10-n N.sup.1 +.sub.2n (WO.sub.4.sup.3-).sub.6 mU.sup.x-

where n is an integer form 1 to 10, and m is 2 when x is 1, or m is 1 when x is 2, M and N are alkali or alkaline earth metals;

WO₄ is an acid radical and W is phosphorus, vanadium, sulfur, silicon, or is substituted in whole or part with carbonate (CO₃^2--); and

U is a halide hydroxide, or carbonate;

provided in an amount effective to increase the amount of force necessary to remove the implanted surgical device.

2. The process of claim 1 wherein the sealant and/or adhesive is applied to the site where the implantable surgical device is to be secured.

3. The process of claim 1 wherein the surgical device is selected from the group consisting of screws, pins, plates, anchors, rods, clamps, clips, staples, rivets, hooks, buttons and snaps.

4. The process of claim 1 wherein the surgical device is made of a bioabsorbable polymeric material.

5. The process of claim 1 wherein the adhesive and/or sealant is a bioabsorbable semi-crystalline aliphatic poly(ester) homopolymer selected from the group consisting of poly(ε

-caprolactone), poly(p-dioxanone), and poly(trimethylene carbonate).

7. The process of claim 1 wherein the adhesive and/or sealant is applied to the implantable surgical device and the surgical device is then secured to the bone tissue.

6. A process for enhancing the security of implantable surgical devices secured to bone tissue comprising securing a surgical device to bone with a bioabsorbable semi-crystalline aliphatic poly(ester) copolymer composed of from about 100 mole percent to about 70 mole percent of ε

-caprolactone repeating units with the remainder of the polymer being a plurality of second lactone repeating unit selected from the group consisting of glycolide repeating units, lactide repeating units, 1,4-dioxanone repeating units, 1,4-dioxepan-2-one repeating units, 1,5-dioxepan-2-one repeating units, trimethylene carbonate repeating units, and combinations thereof provided in an amount effective to increase the amount of force necessary to remove the implanted surgical device.

8. An implantable surgical device consisting essential of an implantable surgical device that is at least partially coated with a biocompatible adhesive and/or sealant selected from the group consisting of:

(a) a bioabsorbable semi-crystalline aliphatic poly(ester) of the formula;

space="preserve" listing-type="equation">[--O--R.sup.11 --C(O)--].sub.Y,

wherein R¹¹ is selected from the group consisting of --CR¹² H--, --(CH₂)₃ --O--, --CH₂ --CH₂ --O--CH₂ --, CR¹² H--CH₂, --(CH₂)₄ --, --(CH₂)_Z --O--C(O)-- and --(CH₂)_z --C(O)--CH₂ --;

R¹² is hydrogen or methyl;

z is an integer in the range of from 1 to 7 and y is an integer in the range of from about 10 to about 20,000; and

(b) a slurry of water and a calcium containing compound with the general formula;

space="preserve" listing-type="equation">M.sup.2 +.sub.10-n N.sup.1+.sub.2n (WO.sub.4.sup.3-).sub.6 mU.sup.x -

where n is an integer from 1 to 10, and m is 2 when x is 1, or m is 1 when x is 2, M and N are alkali or alkaline earth metals;

WO₄ is an acid radical and W is phosphorus, vanadium, sulfur, silicon, or is substituted in whole or part with carbonate (CO₃^2-); and

U is a halide, hydroxide, or carbonate;

provided in an amount effective to increase the amount of force necessary to remove the implanted surgical device.

9. The surgical devices of claim 8 wherein the surgical device is selected from the group consisting of screws, pins, plates, anchors, rods, clamps, clips, staples, rivets, hooks, buttons and snaps.

10. The surgical device of claim 8 wherein the surgical device is made of a bioabsorbable polymeric material.

11. The surgical device of claim 8 wherein the adhesive and/or sealant that at least partially coats the surgical device is a bioabsorbable semi-crystalline aliphatic poly(ester) homopolymer selected from the group consisting of poly(ε

-caprolactone), poly(p-dioxanone), and poly(trimethylene carbonate).

12. An implantable surgical device comprising an implantable surgical device that is at least partially coated with a bioabsorbable semi-crystalline aliphatic poly(ester) copolymer composed of from about 100 mole percent to about 70 mole percent of ε

-caprolactone repeating units with the remainder of the polymer being a plurality of second lactone repeating units selected from the group consisting of glycolide repeating units, lactide repeating units, 1,4-dioxanone repeating units, 1,4-dioxepan-2-one repeating units, 1,5-dioxepan-2-one repeating units, trimethylene carbonate repeating units, and combinations thereof provided in an amount effective to increase the amount of force necessary to remove the implanted surgical device.