Implant system having a functional implant composed of degradable metal material

• US 8,623,097 B2
• Filed: 07/08/2009
• Issued: 01/07/2014
• Est. Priority Date: 07/08/2008
• Status: Active Grant

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Inventors: Gerold, Bodo, Klocke, Bjoern, Fringes, Matthias
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/499,137
• Publication Number:
  US 20100010640A1
• Time in Patent Office: 1,644 Days
• Field of Search: 623/24, 623/23.75, 623/16.11, 606/60
• US Class Current: 623/24
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30107 using materials or accessories for preventing galvanic or electrolytic corrosion
• CPC Class Codes: A61F 2002/30668 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0009 using materials or accessories for preventing galvanic or electrolytic corrosion
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0043 differing in electric properties, e.g. in electrical conductivity, in galvanic properties
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

An implant system comprising a functional implant (5, 6) that fulfills a medical function, particularly a bone implant, which is formed at least in part of a metal material that can be degraded by the body (2) of the implant wearer, as well as a control device (7) for controlling the degradation behavior of the functional implant (5, 6). The control device (7) has a counter-electrode (10) to the functional implant (5, 6), and a voltage source (8) for making available a polarization voltage (ΔU) between functional implant (5, 6, 15) and counter-electrode (10), to control the degradation behavior of the functional implant (5, 6).

Claims

1. An implant system, comprising:

a) a medical implant having a support, fixation, or hold function formed at least in part from a metal material that can be degraded by the body of the implant wearer, and

b) a control device for controlling the degradation behavior of the medical implant, the control device having

(i) at least one counter-electrode to the medical implant, the counter-electrode separate from the medical implant, and

(ii) a voltage source adapted to apply a polarization voltage (Δ

U) between medical implant and counter-electrode, to control the degradation behavior of the medical implant.

2. The implant system of claim 1, further comprising at least one reference electrode for determining the voltage (U_ref) actually applied to the medical implant.

3. The implant system of claim 2, wherein the reference electrode comprises a material selected from the group consisting of platinum, platinum-iridium alloy, gold, and carbon.

4. The implant system of claim 2, wherein the reference electrode is on the medical implant.

5. The implant system of claim 1, wherein the voltage source comprises an implantable battery.

6. The implant system of claim 1, wherein the control device has a separately implantable counter-electrode.

7. The implant system of claim 1, wherein the counter-electrode is formed by the housing of the implantable control device.

8. The implant system of claim 1, wherein the voltage source is switchable either by means of cutting the line connection to the counter-electrode or by means of explantation.

9. The implant system of claim 1, wherein the medical implant comprises one or more metal materials of the group consisting of iron, magnesium, zinc, and tungsten, and alloys of the foregoing.

10. The implant system of claim 1, wherein the counter-electrode comprises either a precious metal or a degradable metal material that is more precious than the metal material of the medical implant.

14. The implant system of claim 1, wherein either the medical implant or the control unit is coated with at least one coating that is permanent or degradable in vivo, from which coating at least one therapeutic agent or pharmacologically active substance can be released.

15. The implant system of claim 14, wherein the coating is selected from the group consisting of a polymer, a metal, an alloy and a ceramic.

20. The implant system of claim 1, wherein the voltage source is adapted to apply a first polarization voltage (Δ

U) between the medical implant and the counter-electrode to reduce or prevent degradation of the medical implant at a first time and a second polarization voltage less than the first polarization voltage to increase degradation of the medical implant at a later time.

11. An implant system, comprising:

a) a medical implant formed at least in part from a metal material that can be degraded by the body of the implant wearer, and

b) a control device for controlling the degradation behavior of the medical implant, the control device having

(i) at least one counter-electrode to the medical implant, the counter-electrode separate from the medical implant,

(ii) a voltage source adapted to apply a polarization voltage (Δ

U) between medical implant and counter-electrode, to control the degradation behavior of the medical implant, and

(iii) a telemetrical data transmission unit.

12. An implant system, comprising:

a) a medical implant formed at least in part from a metal material that can be degraded by the body of the implant wearer, and

b) a control device for controlling the degradation behavior of the medical implant, the control device having

(i) at least one counter-electrode to the medical implant, the counter-electrode separate from the medical implant,

(ii) a voltage source adapted to apply a polarization voltage (Δ

U) between medical implant and counter-electrode, to control the degradation behavior of the medical implant, and

(iii) a telemetrical data transmission unit,

wherein either measurement data concerning the status of the medical implant or control data for controlling the polarization voltage (Δ

U) generated by the voltage source can be transmitted by way of the telemetrical data transmission unit.

13. An implant system, comprising:

a) a medical implant formed at least in part from a metal material that can be degraded by the body of the implant wearer, the medical implant having at least one depot chamber filled with a therapeutic agent and

b) a control device for controlling the degradation behavior of the medical implant, the control device having

(i) at least one counter-electrode to the medical implant, the counter-electrode separate from the medical implant,

(ii) a voltage source adapted to apply a polarization voltage (Δ

U) between medical implant and counter-electrode, to control the degradation behavior of the medical implant, and

(iii) a telemetrical data transmission unit,

wherein the depot chamber is at least partly formed by a metal material whose degradation can be controlled by means of the control device.

16. An implant system, comprising:

a) a medical implant formed at least in part from a metal material that can be degraded by the body of the implant wearer, and

b) an implantable control device for controlling the degradation behavior of the medical implant, the control device having

(i) at least one implantable counter-electrode to the medical implant, the counter-electrode separate from the medical implant, and

(ii) an implantable battery adapted to apply a first polarization voltage (Δ

U) between the medical implant and the counter-electrode to reduce or prevent degradation of the medical implant at a first time and a second polarization voltage less than the first polarization voltage to increase degradation of the medical implant at a later time.

17. The implant system of claim 16, further comprising at least one reference electrode for determining the voltage (U_ref) actually applied to the medical implant.

18. The implant system of claim 17, wherein the reference electrode is embedded in the counter-electrode and wherein the reference electrode is insulated from the counter-electrode.

19. The implant system of claim 16, wherein the counter-electrode is formed by the housing of the implantable control device.