Bi-directional infuser pump with volume braking for hydraulically controlling an adjustable gastric band

• US 7,374,565 B2
• Filed: 05/28/2004
• Issued: 05/20/2008
• Est. Priority Date: 05/28/2004
• Status: Expired due to Fees

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Hassler, William L. Jr., Dlugos, Daniel F. Jr.
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US10/857,763
• Publication Number:
  US 20050277960A1
• Time in Patent Office: 1,453 Days
• Field of Search: 606/151, 606/153, 600/207, 417/472, 417/15, 417/394, 604/890.1, 604/891.1, 604/99.01, 604/288.01, 604/288.02, 604/288.03, 604/288.04, 607/61
• US Class Current: 606/151
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0053 remotely adjustable

Abstract

An implantable artificial sphincter system provides long-term adjustment via transcutaneous energy transfer (TET), minimizing invasive adjustment through adding or removing fluid via a syringe. An infuser device provides bi-directional fluid transfer via a flexible conduit to a sphincter band, such as a gastric band, by a combination of thermodynamic actuation and a piezo-electrically disengaged drum brake assembly that thereby achieves a desirable small volume device. A propellant within a propellant cavity surrounds a metal bellows accumulator biased at body temperature to either expand or collapse the bellows accumulator with the opposite direction of movement effected by a thermal element that heats in combination with a negatively-biased propellant or cools in combination with a positively-biased propellant. A drum brake assembly locks the metal bellows accumulator in place between adjustments by thermodynamic actuation by activating piezo-electric stack actuators that disengage calipers from a brake drum attached to the bellows accumulator.

Claims

1. An implantable device, comprising:

an enclosure;

an accumulator comprising a cylindrical bellows contained within the enclosure and including a movable portion operably configured to vary an internal volume of the accumulator in relation to linear motion of the movable portion;

a contact surface external to the accumulator and connected to the movable portion for bi-directional movement between a collapsed accumulator position and an expanded accumulator position, the contact surface comprising a brake drum externally aligned parallel to the linear motion of the movable portion;

a braking member within the enclosure and proximally positioned and operably configured for movement between a braking contact position locking the movable portion to a present position at any selected position along a range of positions of the movable portion and a noncontact position with the contact surface allowing unimpeded linear movement of the movable portion, wherein the braking member comprises at least one brake caliper encompassing at least a portion of a circumference of the brake drum; and

a brake actuator comprising a piezo-electric stack actuator operably configured to selectively position the braking member.

2. The implantable device of claim 1, further comprising a single propellant cavity defined internal to the enclosure and external to the accumulator, the device further comprising:

a propellant having a liquid/gas phase near body temperature and present in the propellant cavity to pressure bias the accumulator for movement; and

a heat flux element operably configured to adjust a temperature of the propellant to reverse the pressure bias on the accumulator,

wherein the single propellant cavity actuates the movable portion bi-directionally.

3. The implantable device of claim 2, wherein at body temperature the propellant exerts a positive gauge pressure on the accumulator urging the movable portion toward the collapsed accumulator position, the heat flux element comprising a cooling element.

4. The implantable device of claim 2, wherein at body temperature the propellant exerts a negative gauge pressure on the accumulator urging the movable portion toward the expanded accumulator position, the heat flux element comprising a heating element.

5. An implantable device, comprising:

an enclosure;

an accumulator contained within the enclosure and including a movable portion operably configured to vary an internal volume of the accumulator;

a thermal pressure system operatively configured to vary pressure within the enclosure external to the accumulator to urge the movable portion of the accumulator to move;

a contact surface external to the accumulator and connected to the movable portion for bi-directional movement between a collapsed accumulator position and an expanded accumulator position;

a braking member within the enclosure and proximally positioned and biased into braking contact with the contact surface; and

a brake actuator operably configured to deflect the braking member from braking contact with the contact surface, wherein the brake actuator comprises a piezo-electric stack actuator.

6. The implantable device of claim 5, wherein the accumulator comprises a bellows accumulator.

7. The implantable device of claim 6, wherein the accumulator comprises a cylindrical bellows accumulator, the contact surface comprising a brake drum.

8. The implantable device of claim 7, wherein the braking member comprises at least one brake caliper encompassing at least a portion of a circumference of the brake drum.

9. The implantable device of claim 5, wherein the thermal pressure system comprises:

a single propellant cavity defined internal to the enclosure and external to the accumulator, the device further comprising;

a propellant having a liquid/gas phase near body temperature and present in the propellant cavity to pressure bias the accumulator for movement; and

a heat flux element operably configured to adjust a temperature of the propellant to reverse the pressure bias on the accumulator,

wherein the single propellant cavity actuates the accumulator bi-directionally.

10. The implantable device of claim 9, wherein at body temperature the propellant exerts a positive gauge pressure on the accumulator urging the movable portion toward the collapsed accumulator position, the heat flux element comprising a cooling element.

11. The implantable device of claim 9, wherein at body temperature the propellant exerts a negative gauge pressure on the accumulator urging the movable portion toward the expanded accumulator position, the heat flux element comprising a heating element.

12. An implanted apparatus, comprising:

a hydraulically inflatable therapeutic member; and

an infuser device in fluid communication with the hydraulically inflatable therapeutic member for adjusting a fluid volume therein, the infuser device comprising;

an enclosure;

an accumulator contained within the enclosure and including a movable portion operably configured to vary an internal volume of the accumulator;

a contact surface external to the accumulator and connected to the movable portion for bi-directional movement between a collapsed accumulator position and an expanded accumulator position;

a braking member within the enclosure and proximally positioned and biased into braking contact with the contact surface; and

a brake actuator operably configured to deflect the braking member from braking contact with the contact surface, wherein the brake actuator comprises a piezo-electric stack actuator.

13. The implanted apparatus of claim 12, wherein the hydraulically inflatable therapeutic member comprises an implantable band operably configured to encircle a bodily lumen of a patient and including an inwardly directed fluid bladder for adjusting an inner diameter.

14. The implanted apparatus of claim 13, further comprising a transcutaneous energy transfer system including a primary coil external to a patient and a secondary coil in electrical communication with the infuser device.

15. The implanted apparatus of claim 13, further comprising a thermal pressure system operatively configured to vary pressure within the enclosure external to the accumulator to urge the movable portion of the accumulator to move.