WO-2026096299-A1 - PHYSICIAN CONTROL OF BODILY IMPLANT

Abstract

A medical device (100) includes a bodily implant (101), a first external controller (120), and a second external controller (140). The bodily implant has a communications module (108C). The first external controller has a communications module configured to communicate with the communications module of the bodily implant. The second external controller has a communications module configured to communicate with the communications module of the bodily implant.

Inventors

• WATSCHKE, BRIAN P.
• BORGOS, NATALIE ANN
• PROZELLER, SARAH
• JOHNSON, MATTHEW
• HIEBERT, JAMES F.

Assignees

• BOSTON SCIENTIFIC SCIMED, INC.

Dates

Publication Date

20260507

Application Date

20251024

Priority Date

20251023

Claims (20)

1. 1 . A medical device, comprising: a bodily implant having a communications module; a first external controller having a communications module configured to communicate with the communications module of the bodily implant; and a second external controller having a communications module configured to communicate with the communications module of the bodily implant.
2. 2. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member.
3. 3. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the second external controller being configured to communicate with the bodily implant to set a limit on an amount of time the inflatable member remains in the inflated configuration.
4. 4. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in a deflated configuration, Atty Docket No. 0073-689W01 the second external controller being configured to communicate with the bodily implant to set a limit on an amount of time the inflatable member remains in the inflated configuration.
5. 5. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in a partially inflated configuration and a fully inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the partially inflated configuration, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the fully inflated configuration, the second external controller being configured to communicate with the bodily implant to allow the inflatable member to be placed in the partially inflated configuration, the second external controller being configured to communicate with the bodily implant to prevent the inflatable member from being placed in the fully inflated configuration.
6. 6. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in a partially inflated configuration and a fully inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the partially inflated configuration, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the fully inflated configuration, the second external controller being configured to communicate with the bodily implant to allow the inflatable member to be placed in the partially inflated configuration, the second external controller being configured to communicate with the bodily implant to prevent the inflatable member from being placed in the fully inflated configuration for a period of time. Atty Docket No. 0073-689W01
7. 7. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily- implant to cause the inflatable member to be placed in the inflated configuration, the second external controller being configured to communicate with the bodily implant to set a maximum limit on a number of times the inflatable member may be placed in the inflated configuration for a period of time.
8. 8. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the second external controller being configured to communicate with the bodily implant to set a maximum limit on a number of times the inflatable member may be placed in the inflated configuration within a 24-hour period.
9. 9. The medical device of claim 1 , wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the second external controller being configured to communicate with the bodily implant to prevent that inflatable member from being placed in the inflated configuration.
10. 10. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, Atty Docket No. 0073-689W01 the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the second external controller being configured to communicate with the bodily implant to prevent that inflatable member from being placed in the inflated configuration for a first period of time, the second external controller being configured to communicate with the bodily implant to allow the inflatable member to be placed in the inflated configuration during a second period of time different than the first period of time.
11. 11. The medical device of claim 1, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the second external controller being configured to communicate with the bodily- implant to provide implant data from the bodily implant to the second external controller.
12. 12. The medical device of any of claims 1-11, wherein the communications module of the first external controller is configured to communicate with the communications module of the bodily implant via Bluetooth.
13. 13. The medical device of any of claims 1-11, wherein the communications module of the first external controller is configured to communicate with the communications module of the bodily implant via Bluetooth, and the communications module of the second external controller is configured to communicate with the communications module of the bodily implant via Bluetooth.
14. 14. The medical device of any of claims 1-11, wherein the bodily implant is a penile implant.
15. 15. The medical device of any of claims 1-11, wherein the bodily implant is an artificial sphincter. Atty Docket No. 0073-689W01
16. 16. A medical device, comprising: a bodily implant having a communications module; a first external controller having a communications module configured to communicate with the communications module of the bodily implant; and a second external controller having a communications module configured to communicate with the communications module of the bodily implant.
17. 17. The medical device of claim 16, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member.
18. 18. The medical device of claim 16, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the second external controller being configured to communicate with the bodily implant to set a limit on an amount of time the inflatable member remains in the inflated configuration.
19. 19. The medical device of claim 16, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily- implant to cause the inflatable member to be placed in the inflated configuration, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in a deflated configuration, the second external controller being configured to communicate with the bodily implant to set a limit on an amount of time the inflatable member remains in the inflated configuration. Atty Docket No. 0073-689W01
20. 20. The medical device of claim 16, wherein the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in a partially inflated configuration and a fully inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the partially inflated configuration, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the fully inflated configuration, the second external controller being configured to communicate with the bodily implant to allow the inflatable member to be placed in the partially inflated configuration, the second external controller being configured to communicate with the bodily implant to prevent the inflatable member from being placed in the fully inflated configuration.

Description

Atty Docket No. 0073-689W01 PHYSICIAN CONTROL OF BODILY IMPLANT CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of, and claims priority to, U.S. Nonprovisional Patent Application No. 19/367,257, filed on October 23, 2025, entitled ■'PHYSICIAN CONTROL OF BODILY IMPLANT’; which claims priority to U.S. Provisional Patent Application No. 63/713,370, filed on October 29, 2024, entitled “PHYSICIAN CONTROL OF BODILY IMPLANT”, the disclosures of which are incorporated by reference herein in their entirety. [0002] This application also claims priority to U.S. Provisional Patent Application No. 63/713,370, filed on October 29, 2024, the disclosure of which is incorporated by reference herein in its entirety. TECHNICAL FIELD [0003] This disclosure relates generally to bodily implants, and more specifically to bodily implants that include a fluid control system and that can be controlled by a patient and a physician. BACKGROUND [0004] Active implantable fluid-operated inflatable devices can include one or more pumps that regulate the flow of fluid between different portions of the implantable device. One or more valves can be positioned within fluid passageways of the device to direct and control the flow of fluid to achieve inflation, deflation, pressurization, depressurization, activation, deactivation and the like of different fluid-filled components of the device. For example, flow of fluid may be directed to an inflatable member to place the inflatable member in an inflated configuration. Similarly, flow of fluid may be directed away from the inflatable member to place the inflatable member in a deflated configuration. In some implantable fluid-operated devices, an implantable pumping device may be electrically operated. For example, in some devices, the implantable pumping device may be electrically operated using a device located outside of the body of the patient. [0005] In some cases, a patient may use a device located outside of the body of the patient to control an implantable pumping device disposed within the body of the patient. Atty Docket No. 0073-689W01 There is a need for a physician to control the implantable pumping device or provide parameters within which the patient may then be able to control the implantable pumping device. SUMMARY [0006] According to a general aspect, a medical device includes a bodily implant, a first external controller, and a second external controller. The bodily implant has a communications module. The first external controller has a communications module configured to communicate with the communications module of the bodily implant. The second external controller has a communications module configured to communicate with the communications module of the bodily implant. [0007] In some implementations, the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member. [0008] In some implementations, the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the second external controller being configured to communicate with the bodily implant to set a limit on the amount of time the inflatable member remains in the inflated configuration. [0009] In some implementations, the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in an inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the inflated configuration, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in a deflated configuration, the second external controller being configured to communicate with the bodily implant to set a limit on the amount of time the inflatable member remains in the inflated configuration. [0010] In some implementations, the bodily implant includes a fluid reservoir, an inflatable member configured to receive fluid to place the inflatable member in a partially Atty Docket No. 0073-689W01 inflated configuration and a fully inflated configuration, and a pump fluidically connected between the fluid reservoir and the inflatable member, the first external controller being configured to communicate with the bodily implant to cause the inflatable member to be placed in the partially inflated configuration, the