PROSTHETIC HEART DEVICES HAVING DIAGNOSTIC CAPABILITIES

• US 20160045316A1
• Filed: 08/13/2015
• Published: 02/18/2016
• Est. Priority Date: 08/18/2014
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Fahim, Mina S., Moon, Loell Boyce, Ashworth, Paul E., Saikrishnan, Neelakantan, Anderl, Steven Frederick
• Granted Patent: US 10,433,791 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2210/0066 : shrinkable
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0034 : D-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0002 : for data transfer
• CPC Class Codes: A61F 2250/0004 : adjustable
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2250/0065 : telescopic

Abstract

A prosthetic device for implanting in a patient'"'"'s heart includes (i) a therapeutic device capable of restoring function to a native heart valve; and (ii) at least one sensor including a body, an inductor coil disposed within the body, and a capacitor in communication with the inductor coil, the at least one sensor being coupled to the therapeutic device, and being configured to monitor proper function of the therapeutic device within the patient'"'"'s heart.

Claims

1. A prosthetic device for implanting in a patient'"'"'s heart, comprising:

a therapeutic device capable of restoring desired function to a native heart valve; and

at least one sensor coupled to the therapeutic device and configured to monitor the function of the therapeutic device within the patient'"'"'s heart, the sensor including a body, an induction coil disposed within the body and a capacitor in electrical communication with the inductor coil.

2. The prosthetic device of claim 1, wherein the therapeutic device is a collapsible prosthetic heart valve including a stent having a proximal end and a distal end and a valve assembly disposed within the stent.

3. The prosthetic device of claim 2, wherein the stent includes an aortic section at the distal end of the stent, and the at least one sensor includes a plurality of sensors circumferentially disposed about the aortic section of the stent.

4. The prosthetic device of claim 2, wherein the stent includes a plurality of commissure features for coupling to the valve assembly, and the at least one sensor includes a plurality of sensors circumferentially disposed between adjacent ones of the plurality of commissure features.

5. The prosthetic device of claim 2, wherein the at least one sensor includes a plurality of sensors disposed on at least one of the proximal end and the distal end of the stent.

6. The prosthetic device of claim 2, wherein the at least one sensor is disposed on a lumenal surface of the stent.

7. The prosthetic device of claim 2, wherein the at least one sensor is disposed on an ablumenal surface of the stent.

8. The prosthetic device of claim 1, wherein the therapeutic device is a surgical valve including a frame having a plurality of posts, a ring-shaped cuff coupled to the frame, and tissue coupled to the plurality of posts to form a one-way valve, the at least one sensor being coupled to the ring-shaped cuff.

9. The prosthetic device of claim 1, wherein the therapeutic device is an annuloplasty ring and the at least one sensor is coupled to a lumenal surface of the annuloplasty ring.

10. A method for diagnosing the functioning of a heart, comprising:

introducing a prosthetic device into the heart, the prosthetic device including (i) a therapeutic device capable of restoring function to a native heart valve, and (ii) at least one sensor including a body, an inductor coil disposed within the body, and a capacitor in communication with the inductor coil, the at least one sensor being coupled to the therapeutic device;

acquiring cardiac measurements via the at least one sensor; and

determining the functioning of the heart based on the cardiac measurements.

11. The method of claim 10, wherein the therapeutic device is a collapsible prosthetic aortic heart valve including a stent, and a valve assembly disposed within the stent, and the step of acquiring the cardiac measurements includes collecting data related to aortic regurgitation.

12. The method of claim 11, wherein the cardiac measurements are blood pressure measurements.

13. The method of claim 11, wherein the cardiac measurements are blood flow measurements.

14. The method of claim 11, further comprising coupling the at least one sensor to a memory and a processor, and calculating an aortic regurgitation index from the cardiac measurements using the processor.

15. The method of claim 14, wherein the step of determining the functioning of the heart includes confirming proper functioning if the calculated aortic regurgitation index is greater than or equal to 25, and confirming improper functioning if the calculated aortic regurgitation index is less than 25.

16. The method of claim 15, further comprising taking a corrective measure if the aortic regurgitation index is less than 25, and recalculating the aortic regurgitation index after the corrective measure is taken.

17. The method of claim 16, wherein the corrective measure includes snaring the collapsible prosthetic aortic heart valve to readjust its position.

18. The method of claim 16, wherein the corrective measure includes performing a valve-in-valve procedure.