Devices, systems, and methods for epicardial cardiac monitoring

• US 10,165,947 B2
• Filed: 12/26/2017
• Issued: 01/01/2019
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Sr., Jose A.
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US15/854,272
• Publication Number:
  US 20180116517A1
• Time in Patent Office: 371 Days
• Field of Search: 600509, 600375
• CPC Class Codes: A61B 2560/066 catheters therefor
• 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: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/688 using adhesives
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

Devices, systems, and methods for remotely monitoring physiologic cardiovascular data are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for the delivery of the sensor to the epicardial surface of the heart. In addition, various disclosed embodiments provide for a memory device capable of receiving the physiologic cardiovascular data collected by the sensors and transmitting such data wirelessly to a remote location.

Claims

1. A sensor assembly for collecting physiologic data from a targeted tissue, the sensor assembly comprising:

a scaffold assembly having a body comprising a top portion, a bottom portion, and a first delivery channel, the bottom portion having a plurality of openings therein and the first delivery channel in fluid communication with the plurality of openings in the bottom portion;

a delivery catheter, the delivery catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;

the first lumen comprising a second delivery channel in fluid communication with the first delivery channel of the scaffold assembly, and the second lumen comprising a wire channel in communication with the bottom portion of the scaffold assembly;

at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor coupled within the body of the scaffold assembly; and

a connecting wire for transferring physiologic data collected by the at least one sensor, the connecting wire comprising a distal end coupled with the at least one sensor and a proximal end encased within the wire channel of the delivery catheter;

wherein the first delivery channel of the scaffold assembly, the second delivery channel of the delivery catheter, and the number of openings in the bottom portion of the scaffold assembly are capable of allowing an adhesive substance to flow therethrough and onto the targeted tissue.

2. The sensor assembly of claim 1, wherein the scaffold assembly is comprised of a flexible material.

3. The sensor assembly of claim 2, wherein the scaffold assembly is capable of shifting between a first folded position comprising a first perimeter dimension and a second open position comprising a second perimeter dimension, wherein the first perimeter dimension is smaller than the second perimeter dimension.

4. The sensor assembly of claim 1, wherein the body of the scaffold assembly further comprises a plurality of magnetic beads embedded therein.

5. The sensor assembly of claim 1, wherein the body of the scaffold assembly surrounds a periphery of the at least one sensor.

6. The sensor assembly of claim 1, wherein the targeted tissue comprises an epicardial surface of a heart.

12. The sensor assembly of claim 1, wherein the at least one sensor is configured for placement on a surface of the targeted tissue.

13. The sensor assembly of claim 1, wherein when the adhesive substance is inserted into the second delivery channel, the adhesive substance can advance from the second delivery channel to the first delivery channel and through the plurality of openings in the bottom portion of the scaffold assembly.

14. The sensor assembly of claim 1, wherein the first delivery channel and the second delivery channel are configured to deliver the adhesive substance therethrough.

15. A method for attaching a sensor assembly to a surface of a targeted tissue comprising the steps of:

positioning the at least one sensor of the sensor assembly of claim 1 on the surface of the targeted tissue.

16. The method of claim 15, further comprising the step of:

inserting the adhesive substance into the second delivery channel of the delivery catheter.

17. The method of claim 16, further comprising the step of:

applying the adhesive substance to the targeted tissue surface by advancing the adhesive substance through the second delivery channel of the delivery catheter, the first delivery channel of the scaffold assembly, and through the plurality of openings in the bottom portion of the scaffold assembly.

18. The method of claim 17, further comprising the step of:

allowing the adhesive substance to adhere to the targeted tissue surface and the bottom portion of the scaffold assembly.

7. A method for attaching a sensor assembly to a surface of a targeted tissue comprising the steps of:

providing a sensor assembly comprising;

a scaffold assembly having a body comprising a top portion, a bottom portion, and a first delivery channel, the bottom portion having a plurality of openings therein and the first delivery channel in fluid communication with the plurality of openings in the bottom portion,

a delivery catheter, the delivery catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;

the first lumen comprising a second delivery channel in fluid communication with the first delivery channel of the scaffold assembly, and the second lumen comprising a wire channel in communication with the bottom portion of the scaffold assembly,

at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor coupled within the body of the scaffold assembly, and

a connecting wire for transferring physiologic data collected from the at least one sensor, the connecting wire comprising a distal end coupled with the at least one sensor and a proximal end encased within the wire channel of the delivery catheter,

wherein the first delivery channel of the scaffold assembly, the second delivery channel of the delivery catheter, and the number of openings in the bottom portion of the scaffold assembly are capable of allowing an adhesive substance to flow therethrough and onto the targeted tissue;

positioning the at least one sensor of the sensor assembly on a targeted tissue surface;

inserting the adhesive substance into the second delivery channel of the delivery catheter;

applying the adhesive substance to the targeted tissue surface by advancing the adhesive substance through the second delivery channel of the delivery catheter, the first delivery channel of the scaffold assembly, and through the plurality of openings in the bottom portion of the scaffold assembly; and

allowing the adhesive substance to adhere to the targeted tissue surface and the bottom portion of the scaffold assembly.

8. The method of claim 7, wherein the adhesive substance is selected from the group consisting of a ferromagnetic adhesive, a biological adhesive, and a nonbiological adhesive.

9. The method of claim 7, wherein the scaffold assembly is comprised of a flexible material and is capable of shifting between a first folded position comprising a first perimeter dimension and a second open position comprising a second perimeter dimension, wherein the first perimeter dimension is smaller than the second perimeter dimension, and wherein the step of positioning the at least one sensor of the sensor assembly on a targeted tissue surface further comprises the steps of:

shifting the scaffold assembly of the sensor assembly into the first folded position;

inserting the sensor assembly into a catheter comprising a proximal end and a distal end; and

delivering the distal end of the catheter containing the sensor assembly via catheterization and percutaneous methods to the targeted tissue.

10. The method of claim 9, further comprising the steps of:

advancing the sensor assembly through the distal end of the catheter;

shifting the scaffold assembly of the sensor assembly into the second open position; and

positioning the at least one sensor of the sensor assembly on the targeted tissue surface.

11. The method of claim 10, further comprising the step of:

withdrawing the catheter.