Multimodality left atrial appendage occlusion device

• US 9,011,551 B2
• Filed: 07/11/2012
• Issued: 04/21/2015
• Est. Priority Date: 07/11/2011
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Oral, Hakan, Morady, Fred
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/546,662
• Publication Number:
  US 20130018413A1
• Time in Patent Office: 1,014 Days
• Field of Search: 606/213, 600/302, 623/23.72
• US Class Current: 623/23.72
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61N 1/057 : Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/37205 : Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37258 : Alerting the patient
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware

Abstract

A left atrial appendage occlusion device is provided that acts in conjunction with a wireless transponder unit. The occlusion device provides a seal of the left atrial appendage opening, while the transponder is inserted into the left atrial appendage to sense one or more physiological conditions and relay the sensed information over wireless communication. Further, all or part of the left atrial appendage may be filled using a biocompatible inert filling material injected into the left atrial appendage as part of deployment of the transponder unit.

Claims

1. An implantable apparatus for blocking a left atrial appendage, the apparatus comprising:

an occlusion device having a positioning stage in which the occlusion device is collapsed for positioning the occlusion device at an opening of the left atrial appendage, the occlusion device having a cover that in a deployed stage encloses the opening and a strut support structure that in a deployed stage fixedly engages the cover to enclose the opening;

a transponder unit configured to sense one or more physiological conditions and configured to wirelessly transmit sensed measurements of the one or more physiological conditions to an external receiver, wherein the transponder unit is a multimodal device having a sensing mode in which the one or more physiological conditions are sensed and a treatment mode in which the transponder unit performs a treatment operation in the left atrial appendage; and

a biocompatible, inert material in liquid phase inserted into the left atrial appendage, wherein the biocompatible, inert material freely suspends the transponder unit within the left atrial appendage.

2. The implantable apparatus of claim 1, wherein the inert material is maintained in the liquid phase within the left atrial appendage until an activation event is triggered that converts the biocompatible, inert material into a solid phase.

3. The implantable apparatus of claim 1, wherein the transponder unit is configured to simultaneously sense rhythm of the atria, pressure, transthoracic impedance, temperature, and oxygen saturation as the one or more physiological conditions.

4. The implantable apparatus of claim 1, wherein the transponder unit is further configured to simultaneously sense pH within the left atrial appendage.

5. The implantable apparatus of claim 1, wherein the transponder unit is passively powered by a power storage device within the transponder unit, the power storage device being inductively powered from an external inductive power source.

6. The implantable apparatus of claim 1, wherein the treatment operation is the application of an electrical signal to the left atrial appendage to alter the heartbeat rhythm of the heart.

7. The implantable apparatus of claim 1, wherein for the treatment operation is the release, by the transponder unit, of a pharmaceutical agent into the left atrial appendage for treatment of atrial fibrillation or heart failure.

8. The implantable apparatus of claim 1, wherein the one or more the physiological conditions comprises core body temperature.

9. The implantable apparatus of claim 1, further comprising an implantable interface unit that communicates with the transponder unit to receive reporting signals corresponding to the sensed measurements, wherein the implantable interface unit is implantable within the body of a subject.

10. The implantable apparatus of claim 9, wherein the implantable interface unit has a power supply mode in which the implantable interface unit inductively recharges the transponder unit.

11. The implantable apparatus of claim 9, wherein the implantable interface unit communicates instructions to program operation of the transponder unit.

12. The implantable apparatus of claim 1, further comprising an external interface unit that communicates with the transponder unit to receive the reporting signals, wherein the external interface unit is external to the body of a subject.

13. The implantable apparatus of claim 12, wherein the external interface unit has a power supply mode in which the external interface unit inductively recharges the transponder unit.

14. The implantable apparatus of claim 12, wherein the external interface unit communicates instructions to program operation of the transponder unit.

15. The implantable apparatus of claim 1, wherein the one or more physiological conditions comprise at least one of rhythm of the atria, pressure, transthoracic impedance, temperature, oxygen saturation, or pH.