IP Library › Granted Patent US 12,274,635
Granted Patent B2
US 12,274,635 · App. 17/738,916 · Granted Apr 15, 2025

Systems and methods of performing surgery using laplace's law tension retraction during surgery

Inventors: Jonathan R. Thompson (Cincinnati, OH); Mark Steven Ortiz (Milford, OH); Saylan James Lukas (Cincinnati, OH); Liam Clayton Groom (Cincinnati, OH)
Assignee: Standard Bariatrics, Inc.
A61F5/0089A61F5/0086A61M13/003A61M25/10
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Quick Facts
Patent No.
US 12,274,635
App. No.
17/738,916
Granted
Apr 15, 2025
Kind
B2
Abstract

Disclosed are embodiments of an apparatus, system, and method for performing a sleeve gastrectomy. The apparatus can include a bougie for insertion into an interior of a stomach, the bougie having a proximal bougie end and a distal bougie end, an inflation lumen having a proximal lumen end and a distal lumen end, the inflation lumen extending from the proximal bougie end through the distal bougie end, a fluid delivery system coupled with the proximal lumen end, the fluid delivery system being operably configured to deliver positive pressure in a predetermined positive pressure range into the stomach, and a monitor coupled with the proximal lumen end operably configured for the monitoring of pressure or volume within the stomach. The bougie can be operably configured to define a resection line for the sleeve gastrectomy when the predetermined positive pressure range is achieved within the stomach.

Claims (51)

1. A system for sleeve gastrectomy comprising:

(a) a first medical device comprising a shaping portion for insertion into an interior of a stomach, the shaping portion comprising at least one balloon portion, and an inflation portion, wherein the inflation portion is operably configured to provide positive pressure or negative pressure to the stomach;

(b) a second medical device comprising a stapler or clamp configured to be positioned externally on the stomach laterally adjacent to the first medical device;

(c) a control system comprising:

(i) one or more sensors configured to generate a balloon channel dataset based on detected pressure within the at least one balloon portion and a stomach channel dataset based on detected pressure within the stomach;

(ii) one or more pumps operable to selectively provide positive pressure or negative pressure to the at least one balloon portion and the inflation portion;

(iii) one or more processors in communication with the one or more sensors and configured to selectively operate the one or more pumps;

wherein the one or more processors are configured to:

(i) operate the one or more pumps to automatically inflate the at least one balloon portion to a preconfigured balloon pressure based on the balloon channel dataset;

(ii) operate the one or more pumps to automatically inflate the stomach to a preconfigured stomach pressure based on the stomach channel dataset;

(iii) while operating the one or more pumps to automatically inflate the stomach, monitor the balloon channel dataset and identify a pressure change in the balloon channel dataset that corresponds to the second medical device becoming adjacent and snug to the shaping portion; and

(iv) in response to the pressure change, provide an indication that the second medical device is adjacent and snug to the shaping portion.

2. The system of claim 1 , wherein the control system further comprises a contact indicator, and the one or more processors are further configured to provide the indication that the second medical device is adjacent and snug to the shaping portion via the contact indicator.

3. The system of claim 2 , wherein the contact indicator comprises one or more of a visual indicator and an audible indicator.

4. The system of claim 1 , wherein the one or more processors are further configured to provide the indication that the second medical device is adjacent and snug to the shaping portion by operating the one or more pumps to automatically deflate the stomach.

5. The system of claim 1 , wherein the one or more processors are further configured to, while operating the one or more pumps to automatically inflate the stomach to the preconfigured stomach pressure, cease operation of the one or more pumps before the preconfigured stomach pressure is reached based upon a time period of inflation exceeding a preconfigured maximum inflation time.

6. The system of claim 1 , wherein the control system further comprises a control interface in communication with the one or more processors and operable to provided user inputs to the one or more processors, wherein the control interface comprises a toggle automatic balloon inflation control, a toggle automatic stomach inflation control, and a manual stomach suction control.

7. The system of claim 6 , wherein the control interface further comprises a sensitivity selector control that is operable to configure a pressure change threshold, and wherein the one or more processors are further configured to identify the pressure change based on the pressure change threshold and the balloon channel dataset.

8. The system of claim 6 , wherein the control interface further comprises a balloon target pressure control that is operable to configure the preconfigured balloon pressure.

9. The system of claim 6 , wherein the control interface further comprises a stomach target pressure control that is operable to configure the preconfigured stomach pressure.

10. A method for sleeve gastrectomy comprising:

(a) providing a first medical device comprising a shaping portion for insertion into an interior of a stomach, the shaping portion comprising at least one balloon portion, and an inflation portion that is operably configured to provide positive pressure or negative pressure to the stomach;

(b) providing a second medical device comprising a stapler or clamp configured to be positioned externally on the stomach laterally adjacent to the first medical device;

(c) providing a control system comprising:

(i) one or more sensors configured to generate a balloon channel dataset based on detected pressure within the at least one balloon portion and a stomach channel dataset based on detected pressure within the stomach;

(ii) one or more pumps operable to selectively provide positive pressure or negative pressure to the at least one balloon portion and the inflation portion;

(iii) one or more processors in communication with the one or more sensors and configured to selectively operate the one or more pumps;

(d) with the one or more processors, operating the one or more pumps to automatically inflate the at least one balloon portion to a preconfigured balloon pressure based on the balloon channel dataset;

(e) with the one or more processors, operating the one or more pumps to automatically inflate the stomach to a preconfigured stomach pressure based on the stomach channel dataset;

(f) with the one or more processors and while operating the one or more pumps to automatically inflate the stomach, monitoring the balloon channel dataset and identifying a pressure change in the balloon channel dataset that corresponds to the second medical device becoming adjacent and snug to the shaping portion; and

(g) with the one or more processors and in response to the pressure change, providing an indication that the second medical device is adjacent and snug to the shaping portion.

11. The method of claim 10 , further comprising, with the one or more processors, providing the indication that the second medical device is adjacent and snug to the shaping portion via a contact indicator of the control system.

12. The method of claim 11 , wherein the contact indicator comprises one or more of a visual indicator and an audible indicator.

13. The method of claim 10 , further comprising, with the one or more processors, providing the indication that the second medical device is adjacent and snug to the shaping portion by operating the one or more pumps to automatically deflate the stomach.

14. A system for sleeve gastrectomy comprising:

(a) a first medical device comprising a shaping portion for insertion into an interior of a stomach, the shaping portion comprising at least one balloon portion, and an inflation portion, wherein the inflation portion is operably configured to provide positive pressure or negative pressure to the stomach;

(b) a second medical device comprising a stapler or clamp configured to be positioned externally on the stomach laterally adjacent to the first medical device;

(c) a controller comprising:

(i) a stomach channel configured to selectively couple an inflation source and a suction source to the inflation portion;

(ii) a balloon channel configured to selectively couple the inflation source and the suction source to the at least one balloon portion;

(iii) a pressure sensor in fluid communication with the balloon channel and configured to generate a balloon channel dataset based on detected pressure within the balloon channel;

(iv) an inflation selector operable to selectively couple the inflation source to the stomach channel or the balloon channel;

(v) a set of suction controls operable to selectively couple the suction source to the stomach channel or the balloon channel;

(vi) an inflation indicator configured to provide an inflation alert in response to the balloon channel dataset indicating that a preconfigured balloon pressure has been reached;

(vii) a contact indicator configured to provide a contact alert in response to the balloon channel dataset indicating that that a preconfigured pressure change has occurred.

15. The system of claim 14 , wherein the preconfigured pressure change is configured to correspond to an expected change in pressure when the second medical device is adjacent and snug to the shaping portion.

16. The system of claim 14 , wherein the inflation indicator and the contact indicator each comprise one or more of a visual indicator and an audible indicator.

17. The system of claim 14 , wherein the inflation indicator and the contact indicator are visual indicators that are configured to illuminate to provide the inflation alert and the contact alert.

18. The system of claim 14 , wherein the controller further comprises a battery configured to provide power to the pressure sensor, and wherein the controller is configured to be disposed of after one or several uses.

19. The system of claim 14 , wherein the controller is configured be coupled in-line and suspended by a set of tubes that couple the inflation source and the suction source to the first medical device.

20. The system of claim 14 , wherein the inflation selector and the set of suction controls are each configured to be mechanically actuated during operation.

Assignments (4)
SECURITY INTEREST Recorded Dec 20, 2022
From: STANDARD BARIATRICS, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 062173/0429 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 5, 2022
From: THOMPSON, JONATHAN R.; LUKAS, SAYLAN JAMES; GROOM, LIAM CLAYTON
To: STANDARD BARIATRICS, INC.
Reel/Frame 060397/0389 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 5, 2022
From: ORTIZ, MARK STEVEN
To: KALEIDOSCOPE INNOVATION, INC.
Reel/Frame 060397/0503 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 5, 2022
From: KALEIDOSCOPE INNOVATION, INC.
To: STANDARD BARIATRICS, INC.
Reel/Frame 060397/0943 →
Continuity (3)
Continuation In Part 17089619 · Nov 4, 2020
Provisional Application 62930254 · Nov 4, 2019
Related Publication 20220257400A1 · Aug 18, 2022
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