Inflation and deflation mechanisms for inflatable medical devices

• US 9,604,038 B2
• Filed: 07/23/2010
• Issued: 03/28/2017
• Est. Priority Date: 07/23/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Pecor, Robert, Kwok, Jason, Ashby, Mark
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US13/386,650
• Publication Number:
  US 20120191126A1
• Time in Patent Office: 2,440 Days
• Field of Search: 604/96.01, 606191-196
• US Class Current: 1/1
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61M 2025/1022 driven by a rotary motor-activated pump
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: F04B 13/00 Pumps specially modified to deliver fixed or variable measured quantities
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F04B 43/1261 the rollers being placed at the outside of the tubular flexible member
• CPC Class Codes: F04B 49/065 and making use of computers

Abstract

According to embodiments, disclosed is an inflation and deflation device for an inflatable medical device, comprising: an inflation tubing disposed between an access block and a roller configured to rotate about an axis of a roller head; wherein the inflation tubing provides fluid communication between a container and the inflatable medical device; wherein the access block and the roller are configured to restrict flow through the inflation tubing at the area of pressure between the roller and the access block; and wherein the rotation of the roller about the axis of the roller head is configured to transport a fluid within the inflation tubing.

Claims

1. A method of controlling inflation of an inflatable medical device, comprising:

determining a target volume of a fluid to be transferred to a medical device, wherein the medical device is an inflatable intragastric balloon system implanted within a stomach of a patient;

determining an initial mass of a container and initial fluid therein;

transferring at least a portion of the fluid from the container to the medical device;

measuring a resulting mass of the container and remaining fluid therein;

calculating the volume of transferred fluid to the medical device; and

if the volume of transferred fluid is substantially equal to the target volume, ending the transferring.

2. The method of claim 1, further comprising:

transferring an excess amount of fluid from the container prior to transferring the fluid from the container to the medical device, whereby the container contains only the target volume of fluid.

3. The method of claim 1, further comprising:

if the volume of transferred fluid is less than the target volume, transferring more of the fluid from the container to the medical device.

4. The method of claim 1, further comprising:

if the volume of transferred fluid is greater than the target volume, transferring fluid from the medical device to the container.

5. The method of claim 1, further comprising:

if the volume of transferred fluid is greater than the target volume, ceasing the transferring.

6. The method of claim 1, wherein calculating the volume of transferred fluid to the medical device comprises:

subtracting the resulting mass of the container and the remaining fluid therein from the initial mass of the container and the initial fluid therein to determine the change in mass;

dividing the change in mass by the density of the fluid.

7. The method of claim 1, wherein the initial mass of a container and fluid therein is known and provided from a manufacturer.

8. The method of claim 1, wherein the target volume is the desired amount of volume to fill the medical device.

9. The method of claim 1, further comprising:

sensing a back pressure corresponding to an inflation state of the inflatable medical device and a resistance to further inflation due to interactions between the inflatable medical device and walls of the stomach; and

ceasing the transferring if the sensed back pressure corresponds to a target inflation state.

10. The method of claim 1, wherein determining the volume of a fluid in a container further comprises:

determining a mass of the fluid in the container; and

dividing the mass of the fluid by the density of the fluid.

11. The method of claim 10, wherein determining the mass of the fluid in the container further comprises:

determining a mass of only the container;

determining a combined mass of the fluid and the container; and

subtracting the mass of only the container from the combined mass of the fluid and the container.

12. The method of claim 10, wherein determining the initial mass of the container and initial fluid therein further comprises:

filling the container to the target volume.

13. The method of claim 10, wherein determining the mass of the fluid in the container further comprises:

filling the container to the target volume, wherein the container has markings for measuring volume.

14. The method of claim 10, wherein determining the mass of the fluid in the container further comprises:

receiving the container from a provider, the container being provided with the target volume.

15. The method of claim 1, further comprising filling the medical device with the fluid as part of an implantation process during a single inflation procedure.

16. A method of controlling deflation of an inflatable medical device, comprising:

determining a target volume of a fluid to be transferred from a medical device, wherein the medical device is an inflatable intragastric balloon system implanted within a stomach of a patient;

determining an initial mass of a container and initial fluid therein;

transferring at least a portion of fluid from the medical device to the container;

measuring a resulting mass of the container and resulting fluid therein;

calculating the volume of transferred fluid from the medical device; and

if the volume of transferred fluid is substantially equal to the target volume, ending the transferring.

17. The method of claim 16, further comprising:

if the volume of transferred fluid is less than the target volume, transferring more of the fluid from the medical device to the container.

18. The method of claim 16, further comprising:

if the volume of transferred fluid is greater than the target volume, transferring fluid from the container to the medical device.

19. The method of claim 16, further comprising:

if the volume of transferred fluid is greater than the target volume, ceasing the transferring.