MEDICAL IMPLANTS AND METHODS FOR DELIVERING BIOLOGICALLY ACTIVE AGENTS

• US 20090112315A1
• Filed: 10/28/2008
• Published: 04/30/2009
• Est. Priority Date: 10/29/2007
• Status: Abandoned Application

• Current Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Fang, Zhibin, Son, Yang W., Levine, Danny L., Vivanco, Juan, Zhang, Kai
• Application Number:
  US12/259,726
• Publication Number:
  US 20090112315A1
• Time in Patent Office: Days
• US Class Current: 623/11.110
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2310/00095 Niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00131 Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00491 Coating made of niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00544 Coating made of tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00976 Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 27/025 Other specific inorganic materials not covered by A61L27/04 - A61L27/12
• CPC Class Codes: A61L 27/04 : Metals or alloys
• CPC Class Codes: A61L 27/44 : having a macromolecular matrix
• CPC Class Codes: A61L 27/52 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body

Abstract

Medical implants, such as orthopedic implants of the type used in partial or total joint replacement procedures, for example. The implants include a porous substrate, and a bearing portion of a polymeric material, for example, which is at least partially molded within the porous substrate. The bearing portion includes a bearing surface that is exposed to an articulating component of another medical implant, and the porous metal substrate contacts the bone for osseointegration of the bone tissue into the porous substrate to anchor the implant. The porous substrate may include biodegradable carrier materials, in the form of one or more layers, that carry biologically active agents such as antibiotics and bone growth factors, for example. The layers of biodegradable carrier materials may be tailored such that, after implantation of the implants, the biologically active agents are released sequentially and/or over time into the surrounding tissue to reduce the chances of infection and/or to promote osseointegration of the implant, for example.

Claims

1. An implant comprising:

a porous substrate;

a bearing portion of polymeric material connected to the porous substrate by infiltration of the polymeric material into at least a portion of the porous substrate, the bearing portion including a bearing surface; and

at least one biologically active agent incorporated into another portion of the porous substrate.

2. The implant of claim 1, wherein the at least one biologically active agent is selected from a group consisting of antibiotics and bone growth factors.

3. The implant of claim 1, further comprising at least one biodegradable carrier material incorporated into the porous substrate, the at least one biodegradable carrier material carrying the at least one biologically active agent.

4. The implant of claim 3, wherein the at least one biodegradable carrier material is present in the form of a plurality of layers within the porous substrate.

5. The implant of claim 4, wherein the plurality of layers comprise at least a first layer and a second layer, and wherein the biodegradable carrier material of the first layer carries an antibiotic and the biodegradable carrier material of the second layer carries a bone growth factor, the second layer located between the first layer and the bearing portion of the implant.

6. The implant of claim 5, wherein the biodegradable carrier material of the first layer differs from the biodegradable carrier material of the second layer, and wherein the biodegradable carrier material of the first layer has an elution time that is less than that of the biodegradable carrier material of the second layer.

7. The implant of claim 4, wherein one of the plurality of layers comprises a barrier layer that delays release of the at least one biologically active agent, whereby the barrier layer lacks a biologically active agent.

8. A system for incorporating biologically active agents into an implant, the system comprising:

an implant comprising;

a porous substrate; and

a bearing portion of polymeric material connected to the porous substrate by infiltration of the polymeric material into at least a portion of the porous substrate, the bearing portion including a bearing surface; and

a mold comprising;

a body that conforms to a shape of the porous substrate; and

at least one channel configured to direct a fluid including at least one biologically active agent into another portion of the porous substrate of the implant.

9. The system of claim 8, wherein the body of the mold is configured to rest directly against the porous substrate of the implant.

10. The system of claim 8, wherein the channel of the mold is configured to receive the fluid under pressure and the body of the mold prevents the pressurized fluid from escaping from the porous substrate of the implant.

11. The system of claim 8, wherein the at least one biologically active agent is selected from a group consisting of antibiotics and bone growth factors.

12. The system of claim 8, wherein the fluid also includes at least one biodegradable carrier material that carries the at least one biologically active agent.

13. A method for incorporating biologically active agents into an implant comprising the steps of:

providing an implant comprising;

a porous substrate; and

a bearing portion of polymeric material connected to the porous substrate by infiltration of the polymeric material into at least a portion of the porous substrate, the bearing portion including a bearing surface; and

injecting at least one biologically active agent into another portion of the porous substrate.

14. The method of claim 13, further comprising the step of mixing the at least one biologically active agent with a biodegradable carrier material to form a viscous fluid prior to the injecting step.

15. The method of claim 13, further comprising the step of placing a mold body against the porous substrate prior to the injecting step, the mold body conforming to a shape of the implant.

16. The method of claim 13, wherein the injecting step is carried out using at least one of a syringe and an injection molding machine.

17. The method of claim 13, wherein the injecting step comprises injecting a first biodegradable carrier material into the porous substrate to form a first layer, the first biodegradable carrier material carrying the at least one biologically active agent.

18. The method of claim 17, further comprising the step of applying a solvent to the porous substrate to remove a portion of the first layer.

19. The method of claim 17, further comprising the step of injecting a second biodegradable carrier material into the porous substrate to form a second layer on top of the first layer, the second biodegradable carrier material carrying another biologically active agent.

20. The method of claim 13, further comprising the step of embedding a film in the porous substrate, wherein the injecting step comprises injecting a first biodegradable carrier material into the porous substrate between the film and the bearing portion of the implant, the first biodegradable carrier material carrying the at least one biologically active agent.

21. The method of claim 20, further comprising the steps of:

applying a solvent to the porous substrate to remove the film; and

injecting a second biodegradable carrier material into an area of the porous substrate once occupied by the film, the second biodegradable carrier material carrying another biologically active agent.