Leadless implantable medical device with osmotic pump

• US 9,592,398 B2
• Filed: 05/12/2011
• Issued: 03/14/2017
• 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.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US13/106,664
• Publication Number:
  US 20120290025A1
• Time in Patent Office: 2,133 Days
• Field of Search: 607/2, 607/3
• US Class Current: 1/1
• 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 pump reservoir positioned within the housing, wherein the pump reservoir is configured to store genetic material, wherein the genetic material is configured to generate at least one of a reduced stimulation threshold or new intrinsic biological pacemaker activity at a target cardiac tissue site of a patient adjacent to the outer surface of the housing, and wherein the genetic material is configured to generate the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity by at least inducing transgene expression to generate biological pacemaker cells in the cardiac tissue of the patient, wherein the biological pacemaker cells are capable of inducing a normal cardiac rhythm autonomously;

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

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

a stimulation module within the housing and coupled to the stimulation energy delivery element, wherein the stimulation module is configured to deliver cardiac pacing to the target cardiac tissue site via the stimulation energy delivery element, the stimulation module comprising a control module configured to detect the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity in response to the delivery of the genetic material to the target cardiac tissue site via the pump and modify at least one parameter defining the stimulation in response to the detection of the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity at the target cardiac tissue site.

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 cardiac 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 cardiac 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 genetic material is configured to generate at least one of a reduced stimulation threshold or new intrinsic biological pacemaker activity by at least inducing transgene expression to reduce a stimulation threshold of cells in the cardiac tissue of the patient.

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

8. 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 cardiac tissue site of the patient.

9. The leadless IMD of claim 8, wherein the fixation element comprises a tine extending outward from the outer surface of the housing.

10. The leadless IMD of claim 1, wherein the control module is configured to detect the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity by at least determining a capture threshold of tissue at the target cardiac tissue site, and wherein the control module is configured to modify the at least one parameter defining the stimulation by at least modifying the at least one stimulation parameter defining the stimulation based on determining the capture threshold.

11. The leadless IMD of claim 1, wherein the control module is configured to detect the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity by at least implementing a capture detection algorithm to detect the reduced stimulation threshold at the target cardiac tissue site, and wherein the control module is configured to modify the at least one parameter defining the stimulation by at least modifying the at least one parameter defining the stimulation based on detecting the reduced stimulation threshold at the target cardiac tissue site.

12. The leadless IMD of claim 1, wherein the control module is configured to detect the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity by at least detecting the new intrinsic biological pacemaker activity at the target cardiac tissue site, and wherein the control module is configured to modify the at least one parameter defining the stimulation by at least decreasing or suspending delivery of stimulation to the target cardiac tissue site based on detecting the new intrinsic biological pacemaker activity at the target cardiac tissue site.

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

14. A method comprising:

delivering, via a pump of a leadless implantable medical device, genetic material to a target cardiac tissue site of a patient, wherein the genetic material is configured to generate at least one of a reduced stimulation threshold or new intrinsic biological pacemaker activity at the target cardiac tissue site of the patient, wherein the genetic material is configured to generate the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity by at least inducing transgene expression to generate biological pacemaker cells in the cardiac tissue of the patient, wherein the biological pacemaker cells are capable of inducing a normal cardiac rhythm autonomously, and wherein the leadless implantable medical device comprises;

a housing defining an outer surface and comprising an outlet,

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

the pump positioned within the housing,

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

a stimulation module within the housing and coupled to the stimulation energy delivery element, the stimulation module comprising a control module;

delivering, via the stimulation module, stimulation to the target cardiac tissue site of the patient via the stimulation energy delivery element, wherein the target cardiac tissue site is adjacent to the outer surface of the housing;

detecting, via the control module, the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity in response to the delivery of the genetic material to the target cardiac tissue site via the pump; and

modifying, via the control module, at least one parameter defining the stimulation in response to the detection of the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity at the target cardiac tissue site.

15. The method of claim 14, wherein detecting the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity comprises implementing a capture detection algorithm to detect the reduced stimulation threshold at the target cardiac tissue site, and wherein modifying the at least one parameter defining the stimulation comprises modifying the at least one parameter defining the stimulation based on detecting the reduced stimulation threshold at the target cardiac tissue site.

16. The method of claim 14, wherein detecting the at least one of the reduced stimulation threshold or the new intrinsic biological pacemaker activity comprises detecting, with the control module, the new intrinsic biological pacemaker activity at the target cardiac tissue site, and wherein modifying the at least one parameter defining the stimulation comprises decreasing or suspending delivery of stimulation to the target cardiac tissue site based on detecting the new intrinsic biological pacemaker activity at the target cardiac tissue site.

17. The method of claim 14, wherein the pump comprises an osmotic pump.