Method of delivering a biphosphonate and/or strontium ranelate below the surface of a bone

• US 8,882,740 B2
• Filed: 12/22/2010
• Issued: 11/11/2014
• Est. Priority Date: 12/23/2009
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Stryker Trauma GmbH (Stryker Corporation)
• Inventors: Procter, Philip, Jnsson, Anders, Arnoldi, Jrg
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US12/975,639
• Publication Number:
  US 20110172632A1
• Time in Patent Office: 1,420 Days
• Field of Search: 604/500, 606/92, 606/86.R
• US Class Current: 604/500
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 2017/922 Devices for impaction, impact element
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants

Abstract

A method for delivering a bisphosphonate and/or strontium ranelate below the surface of a bone using a mechanical force. The method includes the steps of combining a bisphosphonate and/or strontium ranelate with a carrier to form a delivery composition and delivering an effective amount of the delivery composition below the surface of the bone with a mechanical force. Also provided is a method for strengthening a portion of a bone. This method includes the step of delivering an effective amount of a bisphosphonate and/or strontium ranelate below the surface of a portion of a bone with a mechanical force.

Claims

1. A method for delivering a bisphosphonate, strontium ranelate or both below a recess or surface feature of a bone comprising:

a) combining the bisphosphonate, strontium ranelate or both with a carrier to form a delivery composition, wherein the delivery composition is in the form of one selected from the group consisting of a solid, particles and a aggregation of particles

b) placing the delivery composition into the recess or surface feature of the bone

c) placing an impact device atop the delivery composition or seating a fastening device into the recess or surface feature atop the delivery composition; and

d) using mechanical force of the impact device or the fastening device to crush or break the delivery composition while driving an effective amount of the delivery composition about 1 mm to about 10 mm delivering an effective amount of the delivery composition below the recess or surface feature of the bone.

2. The method as set forth in claim 1, wherein the bisphosphonate is selected from the group consisting of alendronate, clodronate, etidronate, ibandronate, neridronate, olpadronate, pamidronate, risedronate, tiludronate, and zoledronate.

3. The method as set forth in claim 2 wherein the bisphosphonate is zoledronate.

4. The method as set forth in claim 1 wherein the carrier is a bone graft material or a bone cement.

5. The method as set forth in claim 4 wherein the bone graft material is a synthetic bone substitute.

6. The method as set forth in claim 5 wherein the synthetic bone substitute comprises tricalcium phosphate and hydroxylapatite.

7. The method as set forth in claim 4 wherein the bone cement comprises hydroxylapatite.

8. The method as set forth in claim 7 wherein the bone cement is a calcium phosphate cement containing hydroxyapatite.

9. The method as set forth in claim 1 wherein the device is a screw.

10. The method as set forth in claim 1, wherein the delivery composition is driven about 2 mm to about 8 mm below the surface of the bone.

11. The method as set forth in claim 1, wherein the delivery composition is driven about 2 mm to about 5 mm below the surface of the bone.

12. The method as set forth in claim 1, wherein the delivery composition is in the shape of wafer or cylinder.

13. The method of claim 1 comprising:

a) combining the bisphosphonate, strontium ranelate, or both with the carrier to form the delivery composition, wherein the delivery composition is in the form of a wafer;

b) placing the wafer atop a tibial plateau;

c) placing the impactor atop the wafer; and

d) delivering the effective amount of the delivery composition below the surface of the bone by driving the wafer below the surface of the bone with the mechanical force using a hammer to strike the impactor.

14. The method of claim 1 comprising:

a) combining the bisphosphonate, strontium ranelate, or both with the carrier to form the delivery composition, wherein the delivery composition is in the form of a cylinder;

b) preparing a hole in the bone for receipt of a screw and placing the cylinder into the hole;

c) seating the screw into the hole; and

d) inserting the screw below the surface of the bone, thereby crushing the cylinder into particles, pushing the particles below the surface of the bone, and delivering an effective amount of the delivery composition below the surface of the surrounding bone.

15. A method for strengthening a portion of a bone comprising delivering an effective amount of bisphosphonate, strontium ranelate, or both below a recess or surface feature of a portion of a bone by:

a) placing the bisphosphonate, strontium ranelate, or both into the recess or surface feature of the bone, wherein the bisphosphonate, strontium ranelate, or both is in the form of one selected from the group consisting of a solid, particles, and an aggregation of particles;

b) placing an impact device atop the bisphosphonate, strontium ranelate, or both;

or seating a fastening device into recess or surface feature atop the bisphosphonate, strontium ranelate, or both; and

c) using the impact device or the fastening device to crush or break the bisphosphonate, strontium ranelate, or both while driving an effective amount of the bisphosphonate, strontium ranelate, or both about 1 mm to about 10 mm below the surface of the bone.

16. The method as set forth in claim 15 wherein the bisphosphonate is selected from the group consisting of alendronate, clodronate, etidronate, ibandronate, neridronate, olpadronate, pamidronate, risedronate, tiludronate, and zoledronate.

17. The method as set forth in claim 16 wherein the bisphosphonate is zoledronate.

18. The method as set forth in claim 15 wherein the device is a screw.

19. The method as set forth in claim 15 wherein the portion of a bone is the portion of a bone adjacent to a bone implant or prosthesis.