Granted Patent B2

US 10,786,380 · App. 15/844,111 · Granted Sep 29, 2020

Inventors: Randal S. Baker (Ada, MI); James A. Foote (Ada, MI); Paul R. Kemmeter (Ada, MI); Frederick J. Walburn (Grand Rapids, MI); Peter M. Wilson (Killingworth, CT); Adam I. Lehman (Northford, CT); Barry J. Smith (Kennett Square, PA); Robert J. Chappolini (Phoenix, MD)

Assignee: BFKW, LLC

A61F5/0079A61B17/00234A61B17/0401A61B17/0469A61B17/064A61B17/0643A61F2/04A61F5/0076A61F5/0083A61B2017/00818A61B2017/0404A61B2017/0464A61B2017/0647A61B2017/0649A61F2002/045

Abstract

Claims (51)

1. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach by proximately withdrawing the deployment device to pull the cardiac member against the cardiac portion of the stomach; and

further deploying the bariatric device from the deployment device in the esophagus.

2. The method as claimed in claim 1 , including guiding the deployment device transorally into the stomach via a guide wire.

3. The method as claimed in claim 1 , wherein the deployment device comprises a tubular member having a cross section configured to be smaller than the recipient's esophagus.

4. The method as claimed in claim 3 , wherein, prior to guiding the deployment device to the stomach, the bariatric device is compressed within the tubular member of the deployment device.

5. The method as claimed in claim 4 , wherein deploying the bariatric device in the stomach includes unfurling the cardiac member from the tubular member.

6. The method as claimed in claim 4 , wherein the cardiac member unfolds from a compressed state to an expanded state when the cardiac member is clear from the distal end portion of the tubular member.

7. The method as claimed in claim 3 , wherein the further deploying the bariatric device includes unfurling the esophageal member from the tubular member.

8. The method as claimed in claim 1 , wherein the bariatric device is at least partially deployed from the distal end portion of the deployment device in the stomach utilizing a pusher inserted within the deployment device.

9. The method as claimed in claim 1 , further including deploying the esophageal member in the esophagus.

10. The method as claimed in claim 1 , wherein after deploying the cardiac member in the stomach, the deployment device is withdrawn proximally to position the cardiac member against the cardiac portion of the stomach.

11. The method as claimed in claim 1 , wherein the deployment device is withdrawn proximally to deploy the esophageal member from the deployment device.

12. The method as claimed in claim 1 , wherein prior to deploying the esophageal member, the cardiac member is oriented in the stomach by rotating the deployment device.

13. The method as claimed in claim 12 , wherein the cardiac member is oriented in the stomach by visualizing a marker on the deployment device.

14. The method as claimed in claim 12 , wherein the cardiac member is oriented in the stomach utilizing fluoroscopy.

15. The method as claimed in claim 1 including anchoring the bariatric device to the recipient after deploying the bariatric device.

16. The method as claimed in claim 15 , wherein the recipient includes a gastro-esophageal junction pseudo-sphincter between the esophagus and the stomach and wherein said anchoring comprises passing at least one tether through the esophageal member, outside of the gastro-esophageal junction pseudo-sphincter through the walls of the esophagus and stomach and through the cardiac member.

17. The method as claimed in claim 15 , wherein said anchoring comprises growing tissue in openings in the bariatric device.

18. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach; and

further deploying the bariatric device from the deployment device in the esophagus, wherein the deployment device comprises a tubular member and wherein the bariatric device is folded into the tubular member with the cardiac member rolled and the esophageal member radially compressed.

19. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach;

further deploying the bariatric device from the deployment device in the esophagus; and

causing strain to be applied by the cardiac member to the cardiac portion of the stomach in the absence of food, including anchoring the esophageal member to the esophagus of the recipient to resist distal migration of the esophageal member with respect to the esophagus, wherein the connector transmits force between the esophageal member and the cardiac member.

20. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach;

further deploying the bariatric device from the deployment device in the esophagus; and

positioning the cardiac member with respect to the cardiac portion of the stomach with at least one line extending outside of the recipient from the bariatric device, wherein at least one line comprises suture material.

21. The method as claimed in claim 20 , including removing at least one line after said positioning.

22. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach;

further deploying the bariatric device from the deployment device in the esophagus; and

positioning the cardiac member with respect to the cardiac portion of the stomach with at least one line extending outside of the recipient from the bariatric device, wherein said at least one line is attached to the esophageal member and is used to snug the cardiac member against the cardiac portion of the stomach.

23. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach;

further deploying the bariatric device from the deployment device in the esophagus; and

positioning the cardiac member with respect to the cardiac portion of the stomach with at least one line extending outside of the recipient from the bariatric device, wherein said at least one line is attached to cardiac member and is used to laterally adjust the cardiac member.

Continuity (9)

Cited By (1)

US 12,599,493