Blood-vessel-anchored cardiac sensor

Patent metadata

Field	Value
Publication number	US-2022233084-A1
Application number	US-202217676015-A
Country	US
Kind code	A1
Filing date	Feb 18, 2022
Priority date	Aug 22, 2019
Publication date	Jul 28, 2022
Grant date	—

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.

First claim

What is claimed is:

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; 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 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 sensor implant device comprises a first arm portion that physically couples the sensor module to the distal anchor, and a second arm portion that physically couples the sensor module to the proximal anchor.

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

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

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

8 . The method of claim 7 , further comprising advancing the delivery system along a pre-positioned guide wire.

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

10 . The method of claim 9 , 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.

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

12 . 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.

13 . A sensor implant device comprising:
a sensor module including a housing and a sensor element; a first stent anchor coupled to the sensor module via a first arm structure portion; and a second stent anchor coupled to the sensor module via a second arm structure portion.

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

15 . The sensor implant device of claim 13 , wherein the sensor element is configured to generate a signal indicative of a physiological parameter.

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

17 . The sensor implant device of claim 13 , wherein the first and second arm structure portions are part of a unitary bridge structure coupled between the first stent anchor and the second stent anchor.

18 . The sensor implant device of claim 17 , wherein the sensor module includes an engagement feature configured to engage with the bridge structure.

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

20 . The sensor implant device of claim 13 , wherein the sensor module includes a channel feature configured to receive therein a guide wire.

21 . The sensor implant device of claim 13 , wherein the sensor element comprises a transducer surface that is at least partially exposed external to the housing.

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

23 . 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;
a second stent anchor device; and
a sensor module physically coupled to the first anchor device and the second anchor device; and
a distal inner shaft disposed at least partially within the outer shaft and configured to axially abut the first anchor device within the outer shaft.

24 . The delivery system of claim 23 , wherein the first anchor device is disposed without the distal inner shaft and distal to the distal inner shaft and the sensor module is disposed at least partially within the distal inner shaft.

25 . The delivery system of claim 24 , further comprising a proximal inner shaft disposed at least partially within the distal inner shaft and configured to axially abut the sensor module within the distal inner shaft.

26 . The delivery system of claim 25 , wherein:
the second anchor device is disposed at least partially within the proximal inner shaft; the proximal inner shaft has a diameter that is less than a diameter of the distal inner shaft; the second anchor device is disposed within the proximal inner shaft in an at least partially compressed configuration; and the second anchor device in the at least partially compressed configuration has a diameter that is less than a diameter of the first anchor device as configured and disposed within the outer shaft.

27 . The delivery system of claim 26 , wherein the second anchor device is coupled to the sensor module via an arm portion that is bent such that an end portion of the second anchor device is distally oriented within the proximal inner shaft.

28 . The delivery system of claim 26 , 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.

29 . The delivery system of claim 28 , wherein the pusher device includes a central lumen configured to receive a guidewire therein.

30 . A sensor implant device comprising:
a stent anchor; a first arm structure connected to the stent anchor and extending axially beyond an axial end of the stent anchor; and a sensor device secured to the first arm structure.

31 . The sensor implant device of claim 30 , wherein the stent anchor is dimensioned to anchor within a pulmonary vein in an expanded deployment configuration.

32 . The sensor implant device of claim 30 , wherein the stent anchor is dimensioned to anchor within a coronary sinus in an expanded deployment configuration.

33 . The sensor implant device of claim 30 , wherein the stent anchor is dimensioned to anchor within at least one of a superior vena cava or an inferior vena cava in an expanded deployment configuration.

34 . The sensor implant device of claim 30 , wherein the first arm structure has shape memory characteristics tha

Assignees

• Edwards Lifesciences Corp

Inventors

• Valdez Michael G

Classifications

• A61F2/966

  with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod · CPC title

• A61B2562/12

  Manufacturing methods specially adapted for producing sensors for in-vivo measurements · CPC title

• A61B5/6882

  Anchoring means · CPC title

• A61B5/0215 Primary

  by means inserted into the body · CPC title

• A61B5/14503

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence) · CPC title