LEADLESS IMPLANTABLE MEDICAL DEVICE WITH OSMOTIC PUMP

• US 20120290025A1
• Filed: 05/12/2011
• Published: 11/15/2012
• Est. Priority Date: 05/12/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Keimel, John G.
• Granted Patent: US 9,592,398 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0575 with drug delivery
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Techniques for delivering genetic material to a target tissue site of a patient via a leadless implantable medical device that includes a pump and a stimulation energy delivery element are described. In some examples, delivery of genetic material to the target tissue site causes transgene expression of tissue at the target tissue site, which may result in generation of new cells or modified properties of existing cells of the target tissue site, facilitating more effective and efficient treatment of a disorder of the patient.

Claims

1. A leadless implantable medical device (IMD) comprising:

a housing defining an outer surface and comprising an outlet;

a stimulation energy delivery element positioned on or within the housing;

a stimulation module within the housing and coupled to the stimulation energy delivery element, wherein the stimulation module is configured to deliver stimulation to a target tissue site of a patient adjacent to the outer surface of the housing via the stimulation energy delivery element;

a pump reservoir positioned within the housing, wherein the pump reservoir is configured to store genetic material; and

a pump positioned within the housing, wherein the pump is configured to deliver the genetic material to the target tissue site via the outlet.

2. The leadless IMD of claim 1, wherein the stimulation module comprises an electrical signal generator configured to generate an electrical signal, and wherein the stimulation energy delivery element comprises a plurality of housing electrodes, wherein the electrical signal generator of the stimulation module is configured to deliver electrical stimulation to the target tissue site via the plurality of housing electrodes.

3. The leadless IMD of claim 1, wherein the stimulation module comprises an optical signal generator configured to generate an optical signal, and wherein the stimulation energy delivery element comprises an optical energy delivery element, wherein the optical signal generator of the stimulation module is configured to deliver optical stimulation to the target tissue site via the optical energy delivery element.

4. The leadless IMD of claim 3, wherein the optical energy delivery element comprises a portion of the housing formed from an at least partially transparent material.

5. The leadless IMD of claim 1, wherein the stimulation module comprises an electrical signal generator configured to generate an electrical signal, and wherein the stimulation energy delivery element comprises a light source, wherein the electrical signal generator is configured to deliver energy to the light source such that the light source delivers optical stimulation to the target stimulation site.

6. The leadless IMD of claim 1, wherein the target tissue site of the patient comprises cardiac tissue of the patient, and wherein the genetic material is configured to induce transgene expression to generate biological pacemaker cells in the cardiac tissue of the patient.

7. The leadless IMD of claim 1, wherein the target tissue site of the patient comprises cardiac tissue of the patient, and wherein the genetic material is configured to induce transgene expression to reduce a stimulation threshold of cells in the cardiac tissue of the patient.

8. The leadless IMD of claim 1, wherein the genetic material comprises genetic material delivered within a capsid of an adeno-associated virus.

9. The leadless IMD of claim 1, further comprising a fixation element coupled to the outer surface of the housing, wherein the fixation element is configured to secure the leadless IMD within the patient proximate to the target tissue site of the patient.

10. The leadless IMD of claim 9, wherein the fixation element comprises a tine extending outward from the outer surface of the housing.

11. The leadless IMD of claim 1, wherein the stimulation module comprises a control module, and wherein the control module is configured to control delivery of stimulation to the target tissue site of the patient via the stimulation energy delivery element.

12. The leadless IMD of claim 11, wherein the control module is configured to be remotely controlled to control delivery of stimulation by at least determining a capture threshold of tissue at the target tissue site and adjusting one or more stimulation parameters based on determining the capture threshold.

13. The leadless IMD of claim 11, wherein the control module is further configured to:

implement a capture detection algorithm to detect a reduced stimulation threshold at the target tissue site, and

modify at least one parameter defining the stimulation based on detecting the reduced stimulation threshold at the target tissue site.

14. The leadless IMD of claim 11, wherein the control module is further configured to provide demand pacing by at least:

detecting biological pacemaker activity at the target tissue site, and

decreasing or suspending delivery of stimulation to the target tissue site based on detecting the biological pacemaker activity at the target tissue site.

15. The leadless IMD of claim 1, wherein the pump comprises an osmotic pump.

16. A method comprising:

delivering genetic material to a target tissue site of a patient via a pump of a leadless implantable medical device,

wherein the leadless implantable medical device comprises;

a housing defining an outer surface and comprising an outlet,

a stimulation energy delivery element positioned on or within the housing,

a stimulation module within the housing and coupled to the stimulation energy delivery element, wherein the stimulation module is configured to deliver stimulation to a target tissue site of a patient adjacent to the outer surface of the housing via the stimulation energy delivery element,

a pump reservoir positioned within the housing, wherein the pump reservoir is configured to store genetic material, and

the pump, wherein the pump delivers the genetic material to the target tissue site via the outlet.

17. The method of claim 16, further comprising delivering stimulation to the target tissue site of the patient via the stimulation module and the stimulation energy delivery element.

18. The method of claim 17, further comprising:

implementing a capture detection algorithm to detect a modified stimulation threshold at the target tissue site; and

modifying at least one parameter defining the stimulation based on detecting the modified stimulation threshold at the target tissue site.

19. The method of claim 17, further comprising providing demand pacing, wherein providing demand pacing comprises:

detecting biological pacemaker activity at the target tissue site, and

decreasing or suspending delivery of stimulation to the target tissue site based on detecting the biological pacemaker activity at the target tissue site

20. The method of claim 16, wherein the pump comprises an osmotic pump.