Claims for Patent: 8,123,716

Summary for Patent: 8,123,716

Title:	Pericardial delivery of treatment
Abstract:	An implantable cardiac therapeutic device having at least one implantable sensor arranged to sense at least one physiologic characteristic of a patient, an implantable therapeutic agent delivery assembly wherein the delivery assembly and a therapeutic agent to be delivered are configured for placement in a patient\'s pericardial space, and a controller in communication with the at least one implantable sensor and with the therapeutic agent delivery assembly wherein the controller evaluates the at least one physiologic characteristic for indications of a condition indicating administration of the therapeutic agent and wherein, upon detection of such indications, induces the therapeutic agent delivery assembly to deliver the agent. Also an implantable patient lead adapted for connection to a separable implantable therapy device, the lead including an implantable therapeutic agent delivery assembly wherein the delivery assembly and a therapeutic agent to be delivered are configured for placement in a patient\'s pericardial space.
Inventor(s):	Kroll; Mark W. (Crystal Bay, MN), Chitre; Yougandh (Valencia, CA)
Assignee:	Pacesetter, Inc. (Sylmar, CA)
Application Number:	11/768,793
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,123,716
Patent Claims:	1. An implantable cardiac therapeutic device comprising: a lead configured for at least partial placement in a pericardial space; at least one implantable sensor on the lead and arranged to sense at least one physiologic characteristic of a patient; an implantable therapeutic agent delivery assembly entirely on the lead, the delivery assembly including a structure for holding a therapeutic agent for subsequent delivery, an agent delivery dispenser coupled to the structure by a conduit and configured to deliver the agent to a target tissue, and a pressure source configured to provide pressure to the structure to induce flow of the agent from the structure to the agent delivery dispenser, wherein at least a portion of the delivery assembly is configured for placement in the pericardial space and the agent is entirely contained within the structure that is entirely on the lead; and an implantable controller configured to be connected with the lead so as to be in electrical communication with the at least one implantable sensor and with the therapeutic agent delivery assembly wherein the controller evaluates the at least one physiologic characteristic for indications of a condition indicating administration of the therapeutic agent and wherein, upon detection of such indications, induces the therapeutic agent delivery assembly to deliver the agent. 2. The device of claim 1, wherein the structure for holding the therapeutic agent comprises an agent solvent reservoir configured to hold a liquid solvent, and a solid agent packet coupled to the reservoir by a second conduit and configured to hold a solid therapeutic agent, wherein the agent delivery dispenser is coupled to the solid agent packet. 3. The device of claim 2, wherein the solid therapeutic agent comprises a powdered form of the agent. 4. The device of claim 2, wherein the agent comprises one of reteplase and alteplase. 5. The device of claim 2, wherein the structure for holding the therapeutic agent comprises a plurality of packets of the solid therapeutic agent configured such that the device delivery assembly can deliver multiple doses of the agent. 6. The device of claim 5, wherein the plurality of packets are dimensioned such that the delivery assembly can deliver different dosages of the agent. 7. The device of claim 5, wherein the plurality of packets contain different types of solid agent such that the delivery assembly can deliver different types of therapeutic agent. 8. The device of claim 2, wherein the agent delivery assembly is configured to deliver multiple doses of a therapeutic agent solution formed by the solid therapeutic agent and the liquid solvent. 9. The device of claim 1, wherein the agent delivery dispenser is configured for placement in the pericardial space. 10. The device of claim 9, wherein the agent delivery dispenser is further configured for fixation to the target tissue. 11. The device of claim 1, wherein the at least one implantable sensor comprises one or more electrodes configured to sense a potential at an implanted location within the patient. 12. The device of claim 1, wherein the agent comprises a thrombolitic agent and wherein the condition comprises myocardial ischemia. 13. The device of claim 1, wherein the controller evaluates the at least one physiologic characteristic for predictive indications of the condition and, upon detection of such predictive indications, induces the therapeutic agent delivery assembly to deliver the agent before symptomatic manifestation of the condition. 14. The device of claim 1, further comprising: an implantable pulse generator; and at least one stimulation electrode on the lead and operatively associated with the pulse generator; wherein the controller is further configured to monitor a cardiac activity of the patient for indications of cardiac arrhythmia and, upon detection of cardiac activity indicating cardiac arrhythmia, inducing the pulse generator and the at least one stimulation electrode to deliver therapeutic electrical stimulation. 15. An implantable patient lead comprising: a lead body having a distal end region configured for placement in a pericardial space; a connector at a proximal end of the lead body adapted for connection to an implantable therapy device; an implantable therapeutic agent delivery assembly entirely on the distal end region of the lead body, the delivery assembly including a structure for holding a therapeutic agent for subsequent delivery, an agent delivery dispenser coupled to the structure by a conduit and configured to deliver the agent to a target tissue, and a pressure source configured to provide pressure to the structure to induce flow of the agent from the structure to the agent delivery dispenser, wherein the delivery assembly is configured for placement in the pericardial space and the agent is entirely contained within the structure that is entirely on the lead; and one or more contacts on the connector, the one or more contacts in electrical contact with the therapeutic agent delivery assembly. 16. The lead of claim 15, further comprising at least one physiologic sensor on the distal end region of the lead body. 17. The lead of claim 16, wherein the at least one physiologic sensor is configured for placement in the pericardial space. 18. The lead of claim 16, wherein the at least one physiologic sensor is an electrode adapted to sense electrical potentials. 19. The lead of claim 15, wherein the structure for holding the therapeutic agent comprises an agent solvent reservoir configured to hold a liquid solvent, and a solid agent packet coupled to the reservoir by a second conduit and configured to hold a solid therapeutic agent, wherein the agent delivery dispenser is coupled to the solid agent packet. 20. The lead of claim 15, wherein the agent delivery dispenser is configured for placement in the pericardial space and is further configured for fixation to the target tissue. 21. The lead of claim 20, wherein the agent delivery dispenser comprises one or more of a micro-needle array, a barb having an internal passage for delivery of the agent, and a helix having an internal passage for delivery of the agent. 22. The lead of claim 15, further comprising at least one stimulation electrode on the distal end region of the lead body and configured for placement in the pericardial space and configured such that electrical stimulations generated by a separable implantable therapy device can be delivered via the lead to the target tissue.

Details for Patent 8,123,716

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172	11/13/1987		2039-03-29
Genentech, Inc.	CATHFLO ACTIVASE	alteplase	For Injection	103172	09/04/2001		2039-03-29
Chiesi Usa, Inc.	RETAVASE	reteplase	For Injection	103786	10/30/1996		2039-03-29