System and Method for Reshaping Heart

Patent metadata

Field	Value
Publication number	US-2020383786-A1
Application number	US-202017001597-A
Country	US
Kind code	A1
Filing date	Aug 24, 2020
Priority date	Dec 30, 2015
Publication date	Dec 10, 2020
Grant date	—

Abstract

The present teachings provide systems, devices, and methods for reshaping the heart and reducing valve regurgitation. A device can be positioned proximate the heart and have a delivery profile and an inflated profile. The device can have a primary cavity and a secondary cavity, and an adhesive inside the secondary cavity. An injectable medium can be injected to the primary cavity of the device. As the primary cavity is filled, the adhesive is forced out of the secondary cavity to adhere the device. The inflated device can exert pressure on the heart, change the shape of a valve annulus, and allow a better coaptation of the valve leaflets.

First claim

We claim:

1 . A system comprising:
an access sheath, configured to be introduced to a treatment location outside a heart of a subject; a delivery catheter; a device configured to be positioned at the treatment location, against the right side of the heart, the device comprising:
a tissue-binding adhesive;
a flexible outer layer encasing a primary cavity and a secondary cavity outside of the primary cavity, a portion of the flexible outer layer outside of the secondary cavity having a plurality of pores between the secondary cavity and the outside of the flexible outer layer;
a barrier separating the primary and secondary cavities, inhibiting moisture from crossing the barrier; and
wherein the device has a collapsed delivery profile and an inflated deployment profile, and in the collapsed delivery profile, the device is dimensioned to be advanced, within the access sheath, to the treatment location, while the secondary cavity contains the tissue-binding adhesive; wherein the device is inflatable to the inflated deployment profile by introducing an injection medium into the primary cavity, and wherein introducing the injection medium into the primary cavity forces at least some of the tissue-binding adhesive out of the secondary cavity via the pores.

2 . The system according to claim 1 , wherein the barrier separating the primary and secondary cavities expands more than the portion of the flexible outer layer outside of the secondary cavity when the injection medium is introduced into the primary cavity, thereby allowing the primary cavity to expand at a greater rate than the secondary cavity, thereby forcing the at least some of the tissue-binding adhesive through the pores.

3 . The system according to claim 1 , wherein the device further includes a one-way valve disposed within an injection tube used to introduce the injection medium into the primary cavity.

4 . The system according to claim 1 , wherein the barrier extends longitudinally from a distal end to a proximal end of the device which is in the form of an inflatable balloon.

5 . The system according to claim 1 , wherein the secondary cavity is disposed alongside the primary cavity.

6 . The system according to claim 1 , wherein:
the portion of the flexible outer layer is a first portion of the flexible outer layer that delineates at least part of the primary cavity, and a second portion of the flexible outer layer delineates at least part of the secondary cavity.

7 . The system according to claim 1 , wherein the primary cavity is configured to inflate into a flat shape.

8 . The system according to claim 1 , wherein the device further comprises an injection port configured to allow the injection medium to be introduced into the primary cavity.

9 . The system according to claim 8 , wherein the injection port comprises an injection tube that is disposed entirely within the primary cavity and is only in fluid communication with the primary cavity and not the secondary cavity, the injection port being configured for being detachably coupled to an inflation catheter

10 . A system comprising:
a device configured to be positioned at the treatment location, against the right side of the heart, the device comprising:
a tissue-binding adhesive;
a flexible outer layer encasing a primary cavity and a secondary cavity outside of the primary cavity, a portion of the flexible outer layer outside of the secondary cavity having a plurality of pores between the secondary cavity and the outside of the flexible outer layer;
a barrier separating the primary and secondary cavities, inhibiting moisture from crossing the barrier; and
wherein the device has a collapsed delivery profile and an inflated deployment profile, and in the collapsed delivery profile, the device is dimensioned to be advanced through a catheter to the treatment location, while the secondary cavity contains the tissue-binding adhesive; wherein the device is configured such that injecting an injection medium into the primary cavity both inflates the device to the inflated deployment profile and forces at least some of the tissue-binding adhesive out of the secondary cavity via the pores.

11 . The system according to claim 10 , wherein the barrier separating the primary and secondary cavities expands more than the portion of the flexible outer layer outside of the secondary cavity when the injection medium is introduced into the primary cavity, thereby allowing the primary cavity to expand at a greater rate than the secondary cavity, thereby forcing the at least some of the tissue-binding adhesive through the pores.

12 . The system according to claim 10 , wherein the barrier extends longitudinally from a distal end to a proximal end of the device which is in the form of an inflatable balloon.

13 . The system according to claim 10 , wherein the secondary cavity is disposed alongside the primary cavity.

14 . The system according to claim 10 , wherein:
the portion of the flexible outer layer is a first portion of the flexible outer layer that delineates at least part of the primary cavity, and a second portion of the flexible outer layer delineates at least part of the secondary cavity.

15 . The system according to claim 10 , wherein the primary cavity is configured to inflate into a flat shape.

16 . The system according to claim 10 , wherein the device further comprises an injection port configured to allow the injection medium to be introduced into the primary cavity.

17 . The system according to claim 16 , wherein the injection port comprises an injection tube that is disposed entirely within the primary cavity and is only in fluid communication with the primary cavity and not the secondary cavity, the injection port being configured for being detachably coupled to an inflation catheter

18 . The system according to claim 17 , wherein the device further includes a one-way valve disposed within the injection tube used to introduce the injection medium into the primary cavity.

Assignees

• Edwards Lifesciences Corp

Inventors

• Sutherland Michael W
• Cahalane Steven D
• House Morgan

Classifications

• A61F2250/0003

  having an inflatable pocket filled with fluid, e.g. liquid or gas · CPC title

• A61F2/2481 Primary

  Devices outside the heart wall, e.g. bags, strips or bands · CPC title

• A61B17/12136

  Balloons · CPC title

• A61M2025/1054

  having detachable or disposable balloons · CPC title

• A61F2230/001

  Figure-8-shaped, e.g. hourglass-shaped · CPC title