Drug delivery device

• US 6,571,125 B2
• Filed: 02/12/2001
• Issued: 05/27/2003
• Est. Priority Date: 02/12/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson, David L.
• Primary Examiner(s): Derakshani, Philippe
• Application Number:
  US09/781,750
• Publication Number:
  US 20020111601A1
• Time in Patent Office: 834 Days
• Field of Search: 604/891.1, 604/20, 128/260
• US Class Current: 604/20
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An Implantable Medical Device (IMD) for controllably releasing a biologically-active agent such as a drug to a body is disclosed. The IMD includes a catheter having one or more ports, each of which is individually controlled by a respective pair of conductive members located in proximity to the port. According to the invention, a voltage potential difference generated across a respective pair of conductive members is used to control drug delivery via the respective port. In one embodiment of the current invention, each port includes a cap member formed of a conductive material. This cap member is electrically coupled to one of the conductive members associated with the port to form an anode. The second one of the conductive members is located in proximity to the port and serves as a cathode. When the cap member is exposed to a conductive fluid such as blood, a potential difference generated between the conductors causes current to flow from the anode to the catheter, dissolving the cap so that a biologically active agent is released to the body. In another embodiment of the invention, each port is in proximity to a reservoir or other expandable member containing a cross-linked polymer gel of the type that expands when placed within an electrical field. Creation of an electric field between respective conductive members across the cross-linked polymer gel causes the gel to expand. In one embodiment, this expansion causes the expandable member to assume a state that blocks the exit of the drug from the respective port. Alternatively, the expansion may be utilized to assert a force on a bolus of the drug so that it is delivered via the respective port. Drug delivery is controlled by a control circuit that selectively activates one or more of the predetermined ports.

Claims

1. A device to provide the controlled release of a biologically-active agent contained therein to a body, comprising:

a cap member, formed of a conductive material, preventing the agent from passing outward from the device to the body;

a first conductor electrically and mechanically coupled to the cap member; and

a second conductor electrically and mechanically isolated from the cap member, the first conductor and the second conductor forming a circuit when a voltage potential difference is generated between the first conductor and the second conductor, the voltage potential difference causing ionization of the cap member to enable the biologically-active agent to pass outward from the device to the body.

2. The device of claim 1, wherein the conductive material forming the cap member is one of copper, gold, silver and zinc.

3. The device of claim 1, wherein the conductive material forming the cap member is a polymer material.

4. The device of claim 1, further comprising a control circuit coupled to the device to selectably generate the voltage potential difference between the first conductor and the second conductor.

5. The device of claim 4, further comprising at least one electrode carried by the device to provide electrical stimulation to the body.

6. The device of claim 5, wherein the control circuit includes processing means for coordinating the delivery of the biologically-active agent with the electrical stimulation.

7. The device of claim 6, wherein the electrode is adapted to provide cardioversion/defibrillation stimulation, and wherein the processing means controls the delivery of the biologically-active agent prior to delivery of the cardioversion/defibrillafion stimulation to reduce patient discomfort associated with the cardioversion/defibrillation stimulation.

8. The device of claim 1, further comprising at least one biological sensor carried by the device to provide a signal indicative of a physiological condition.

9. The device of claim 8, wherein the control circuit includes processing means to control the delivery of the biologically-active agent in response to the signal indicative of the physiological condition.

10. A device to provide the controlled release of a biologically-active agent to a body, comprising:

an outer portion extending from a proximal assembly to a tip portion of the device and defining a plurality of ports through which the biologically-active agent is released from the device to the body;

a plurality of reservoirs containing the biologically-active agent, the plurality of reservoirs formed along the outer portion in fluid communication with the plurality of ports;

a plurality of cap members, formed of a conductive material, positioned over the plurality of reservoirs and preventing the agent from passing outward to the body from the plurality of reservoirs through the plurality of ports;

a plurality of conductor pairs, each of the plurality of conductor pairs including a first conductor, extending from the proximal assembly to the tip portion and electrically and mechanically coupled to one reservoir of the plurality of reservoirs, and a second conductor extending from the proximal assembly to the tip portion and electrically and mechanically isolated from the one reservoir, the first conductor and the second conductor forming a circuit when a voltage potential difference is generated between the first conductor and the second conductor, the voltage potential difference causing ionization of a corresponding one of the plurality of cap members to enable the biologically-active agent to flow from the one reservoir to the body through a corresponding port of the plurality of ports.

11. The device of claim 10, wherein the conductive material forming the plurality of cap members is one of copper, gold, silver and zinc.

12. The device of claim 10, wherein the plurality of cap members are formed of a polymer material.

13. The device of claim 10, further comprising a control circuit coupled to the device to selectably generate the voltage potential difference between the first conductor and the second conductor.

14. The device of claim 13, further comprising at least one electrode carried by the device to provide electrical stimulation to the body.

15. The device of claim 14, wherein the control circuit includes processing means for coordinating the delivery of the biologically-active agent with the electrical stimulation.

16. The device of claim 15, wherein the electrode is adapted to provide cardioversion/defibrillation stimulation, and wherein the processing means controls the delivery of the biologically-active agent prior to delivery of the cardioversion/defibrillation stimulation to reduce patient discomfort associated with the cardioversion/defibrillation stimulation.

17. The device of claim 16, further comprising at least one biological sensor carried by the device to provide a signal indicative of a physiological condition.

18. The device of claim 17, wherein the control circuit includes processing means to control the delivery of the biologically-active agent in response to the signal indicative of the physiological condition.

19. The device of claim 10, wherein the plurality of reservoirs include a first reservoir and a second reservoir, and the biologically-active agent corresponds to a first compound within the first reservoir and to a second compound, different from the first compound within the second reservoir.

20. A method of delivering a biologically-active agent to a body, comprising the steps of:

positioning a device providing the controlled release of the biologically-active along a predetermined location within the body, the device having at least one cap member, formed of a conductive material, preventing the agent from passing outward from the device to the body; and

generating a voltage potential difference between a first conductor electrically and mechanically coupled to the cap member, and a second conductor electrically and mechanically isolated from the cap member, the voltage potential difference causing ionization of the cap member to enable the biologically-active agent to pass outward from the device to the body.