IP Library Granted Patent US 12702311
Granted Patent B2
US 12702311 · App. 17/676,015 · Granted Aug 11, 2026

Blood-vessel-anchored cardiac sensor

Inventor: Michael G. Valdez (Riverside, CA)
Assignee: Edwards Lifesciences Corporation
A61B5/02152A61B5/6851A61B5/686A61B5/6869A61B5/6876A61B2562/0247
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Quick Facts
Patent No.
US 12702311
App. No.
17/676,015
Granted
Aug 11, 2026
Kind
B2
Abstract

A method of sensing a physiological parameter involves advancing a delivery catheter to a right atrium of a heart of a patient via a transcatheter access path, advancing the delivery catheter through an interatrial septum wall into a left atrium of the heart, deploying a distal anchor of a sensor implant device from the delivery catheter, anchoring the distal anchor of the sensor implant device to a first pulmonary vein, withdrawing the delivery catheter away from the first pulmonary vein, thereby exposing at least a portion of a sensor module of the sensor implant device in the left atrium, deploying a proximal anchor of the sensor implant device from the delivery system, anchoring the proximal anchor of the sensor implant device to a second pulmonary vein, and withdrawing the delivery catheter from the heart.

Claims (74)

1 . A method of sensing a physiological parameter, the method comprising:

advancing a delivery system to a right atrium of a heart of a patient via a transcatheter access path;

advancing the delivery system through an interatrial septum wall into a left atrium of the heart;

deploying a distal anchor of a sensor implant device from the delivery system;

anchoring the distal anchor of the sensor implant device to a first pulmonary vein;

withdrawing the delivery system away from the first pulmonary vein, thereby exposing at least a portion of a sensor module of the sensor implant device in the left atrium, the sensor module being coupled to the distal anchor via a first arm segment;

deploying a proximal anchor of the sensor implant device from the delivery system, the proximal anchor being coupled to the sensor module via a second arm segment;

anchoring the proximal anchor of the sensor implant device to a second pulmonary vein, thereby securing the sensor module in a position adjacent to a left atrial wall portion of the left atrium between the first pulmonary vein and the second pulmonary vein; and

withdrawing the delivery system from the heart.

2 . The method of claim 1 , further comprising sensing a physiological parameter associated with the left atrium using a sensor element of the sensor module.

3 . The method of claim 2 , wherein the physiological parameter is left atrial blood pressure.

4 . The method of claim 1 , wherein the first and second arm segments are part of a unitary arm structure coupled between the distal anchor and the proximal anchor.

5 . The method of claim 4 , wherein the sensor module includes an arm engagement feature configured to attach the sensor module to the unitary arm structure.

6 . The method of claim 1 , wherein the sensor module includes a guidewire lumen configured to have a guide wire disposed therein.

7 . The method of claim 6 , further comprising advancing the guidewire lumen of the sensor module along a pre-positioned guide wire.

8 . The method of claim 1 , wherein the sensor module comprises a housing and a sensor element disposed at least partially within the housing.

9 . The method of claim 8 , wherein the sensor element is disposed at least partially within the housing such that a transducer surface of the sensor element is at least partially exposed to blood in the left atrium when the sensor implant device is disposed within the left atrium.

10 . The method of claim 9 , wherein the transducer surface is a pressure transducer diaphragm.

11 . The method of claim 1 , wherein said anchoring the distal anchor of the sensor implant device to the first pulmonary vein involves expanding a stent anchor within a conduit of the first pulmonary vein.

12 . A sensor implant device comprising:

a sensor module including a housing and a sensor element;

a first stent anchor;

a second stent anchor; and

an at least partially flat coupling arm extending from a distal portion of the first stent anchor to a proximal portion of the second stent anchor and running along entire lengths of the first stent anchor and the second stent anchor, the sensor module being attached to a medial portion of the coupling arm between the first and second stent anchors.

13 . The sensor implant device of claim 12 , wherein each of the first and second stent anchors is self-expanding.

14 . The sensor implant device of claim 12 , wherein the sensor element is configured to generate a signal indicative of a physiological parameter.

15 . The sensor implant device of claim 14 , wherein the physiological parameter is fluid pressure.

16 . The sensor implant device of claim 12 , wherein the coupling arm comprises first and second arm segments on opposite sides of the sensor module.

17 . The sensor implant device of claim 12 , wherein the sensor module includes an engagement feature configured to engage with the coupling arm.

18 . The sensor implant device of claim 17 , wherein the engagement feature is associated with an underside of the housing of the sensor module.

19 . The sensor implant device of claim 12 , wherein the sensor module includes a channel feature configured to receive therein a guide wire.

20 . The sensor implant device of claim 12 , wherein the sensor element comprises a transducer surface that is at least partially exposed external to the housing.

21 . The sensor implant device of claim 20 , wherein the transducer surface is associated with a pressure transducer diaphragm.

22 . A delivery system comprising:

an outer shaft;

a sensor implant device disposed at least partially within the outer shaft, the sensor implant device comprising:

a first anchor device disposed within the outer shaft in a first pre-deployment configuration with a first diameter;

a second anchor device; and

a sensor module physically coupled to the first anchor device and the second anchor device via respective connecting arm segments;

a distal inner shaft disposed at least partially within the outer shaft and configured to axially abut a proximal portion of the first anchor device within the outer shaft; and

a proximal inner shaft disposed at least partially within the distal inner shaft and configured to axially abut a proximal portion of the sensor module within the distal inner shaft, the second anchor device being disposed within the proximal inner shaft in a second pre-deployment configuration with a second diameter that is less than the first diameter.

23 . The delivery system of claim 22 , wherein the first anchor device is disposed distal to a distal end of the distal inner shaft and the sensor module is disposed at least partially within the distal inner shaft.

24 . The delivery system of claim 22 , wherein the second anchor device is coupled to the sensor module via one of the respective connecting arm segments that is bent such that an end portion of the second anchor device is distally oriented within the proximal inner shaft.

25 . The delivery system of claim 22 , further comprising a pusher device disposed at least partially within the proximal inner shaft and configured to axially abut the second anchor device within the proximal inner shaft.

26 . The delivery system of claim 25 , wherein the pusher device includes a central lumen configured to receive a guidewire therein.

27 . A sensor implant device comprising:

a first stent anchor;

a first arm structure connected to the first stent anchor and extending axially beyond an axial end of the first stent anchor; and

a sensor device secured to the first arm structure;

wherein the first arm structure projects from an axial end of the first stent anchor and is bent outwardly at an approximately right angle relative to an axis of the first stent anchor, such that the sensor device is positioned entirely radially outside of an outer diameter of the first stent anchor.

28 . The sensor implant device of claim 27 , wherein the first stent anchor is dimensioned so as to be configured to anchor within a pulmonary vein in an expanded deployment configuration.

29 . The sensor implant device of claim 27 , wherein the first arm structure has shape memory characteristics that cause the first arm structure to deflect radially outward with respect to the axis of the first stent anchor when the sensor implant device is deployed.

30 . The sensor implant device of claim 27 , further comprising:

a second stent anchor; and

a second arm structure connected to the second stent anchor and extending beyond an axial end of the second stent anchor;

wherein the sensor device is secured to the second arm structure.

31 . The sensor implant device of claim 30 , wherein the second arm structure has a U-shaped bend that orients an axial end of the second stent anchor towards the sensor device.

32 . The sensor implant device of claim 30 , wherein the first arm structure and the second arm structure are dimensioned to position the sensor device between a first pulmonary vein and a second pulmonary vein.

33 . The sensor implant device of claim 32 , wherein the first arm structure and the second arm structure are adapted to position the sensor device adjacent an atrial wall at a position between the first pulmonary vein and the second pulmonary vein.

34 . The sensor implant device of claim 30 , wherein the second arm structure has shape memory characteristics that cause the second arm structure to deflect radially outward with respect to an axis of the second stent anchor when the sensor implant device is deployed.

35 . A method of sensing a physiological parameter, the method comprising:

advancing a delivery system to a left atrium of a heart of a patient via a transcatheter access path;

deploying a first anchor of a sensor implant device from the delivery system;

anchoring the first anchor of the sensor implant device within a first pulmonary vein;

withdrawing the delivery system away from the first pulmonary vein;

exposing at least a portion of a sensor module of the sensor implant device in the left atrium, the sensor module being coupled to the first anchor via a first support arm segment;

allowing the first support arm segment to bend radially away from an axis of the first anchor to position the sensor module in a position abutting against a wall portion of the left atrium between the first pulmonary vein and a second pulmonary vein; and

withdrawing the delivery system from the heart.

36 . The method of claim 35 , further comprising sensing a physiological parameter associated with the left atrium using a sensor element of the sensor module.

37 . The method of claim 36 , wherein the physiological parameter is left atrial blood pressure.

38 . The method of claim 35 , further comprising:

deploying a second anchor of the sensor implant device from the delivery system; and

anchoring the second anchor of the sensor implant device to a second pulmonary vein, the second anchor being coupled to the sensor module via a second support arm segment.

39 . The method of claim 38 , further comprising allowing the second support arm portion that physically couples the sensor module to the second anchor to bend to a perpendicular orientation relative to an axis of the second anchor.