METHODS, DEVICES, AND SYSTEMS FOR OBESITY TREATMENT

Abstract

Methods and systems for detecting wall breach in inflatable prostheses rely on intrusion of a body fluid or inflation medium to electrically alter a signaling circuit. In one embodiment, an open portion of a circuit is closed to enable or modify a transmitted signal In another embodiment, electrical current is generated to power an electrical transmission.

Claims

1. (canceled)

2. An obesity treatment system for deployment in a stomach of a patient, comprising: a plurality of adjacent, non-concentric, spaced apart inflatable space-filling compartments, wherein each compartment of the plurality of inflatable space-filling compartments has a respective inflated state volume during treatment of the patient; and at least two valves to introduce at least one fluid into the compartments of the plurality of inflatable space-filling compartments and to retain, after inflation, fluid in the plurality of inflatable space-filling compartments, wherein each valve is a one-way valve and wherein at least one of the at least two valves has a proximal end configured to removably attach to an inflation tube; wherein the plurality of inflatable space-filling compartments form, upon at least partially filling the plurality of inflatable space-filling compartments, a dual balloon system that floats within the stomach; wherein, upon inflation, the dual balloon system floats within the stomach without exerting pressure at any point in the stomach sufficient to cause ulceration.

3. The obesity treatment system of claim 2, wherein an outer surface of each of the inflatable space-filling compartments abuts a greater or lesser curvature of the stomach.

4. The obesity treatment system of claim 2, wherein the plurality of inflatable space-filling compartments are untethered in the stomach after inflation.

5. The obesity treatment system of claim 2, further comprising a flexible central spine structure spanning a gap between and connecting the plurality of adjacent, spaced apart inflatable space-filling compartments.

6. The obesity treatment system of claim 5, wherein the flexible central spine structure is in fluid communication with the valve system.

7. The obesity treatment system of claim 6, wherein the flexible central spine structure encloses an inflation lumen for introducing the fluid into the plurality of inflatable space-filling compartments.

8. The obesity treatment system of claim 2, wherein fluid in each of the plurality of inflatable space-filling compartments is a same type of gas.

9. The obesity treatment system of claim 2, further comprising chemicals adapted to be reacted to produce a gas that inflates at least one of the plurality of adjacent, spaced apart inflatable space-filling compartments.

10. A method for deploying a dual balloon system in a gastric cavity of a patient, comprising: introducing a least a first gastric balloon and a second gastric balloon to the gastric cavity, each of said balloons having a respective fill volume and a respective inflation lumen; at least partially filling each of the first gastric balloon and the second gastric balloon with the same type of fluid such that the first and second gastric balloons cooperatively form a dual balloon system that floats within the gastric cavity; wherein the first gastric balloon and a second gastric balloon are non-concentric and adjacent, wherein the inflation lumen of the first gastric balloon is separate from the inflation lumen of the second gastric balloon, wherein at least partially filling each of the first gastric balloon and a second gastric balloon comprises introducing fluid into the respective balloon via its respective inflation lumen.

11. The method of claim 10, wherein the dual balloon system, upon inflation, floats within the gastric cavity without exerting pressure at any point in the gastric cavity sufficient to cause ulceration.

12. The method of claim 11, wherein at least partly filling the first gastric balloon and second gastric balloon comprises: releasably attaching an inflation tube to at least one of the first and second gastric balloons; and introducing a fluid into the first gastric balloon and second gastric balloon.

13. The method of claim 12, wherein introducing a least the first gastric balloon and the second gastric balloon to the gastric cavity comprises introducing each gastric balloon through an esophagus of the patient.

14. The method of claim 13, wherein a diameter of each of the first and second gastric balloons is no larger than 2 centimeters prior to inflation.

15. The method of claim 10, wherein after inflation an outer surface of each of the first and second gastric balloons abuts against greater or lesser curvature of the gastric cavity.

16. The method of claim 10, wherein neither of the first and the second gastric balloon is tethered in the gastric cavity after inflation.

17. The method of claim 10, wherein a flexible central spine structure spans a gap between and connects the first gastric balloon and the second gastric balloon.

18. The method of claim 17, wherein the flexible central spine structure is in fluid communication with the valve system.

19. The method of claim 10, wherein at least partially filling each of the first gastric balloon and the second gastric balloon comprises reacting chemicals to produce a gas that inflates each of the first gastric balloon and the second gastric balloon.

20. A system for treating obesity, comprising: a first means for, upon inflation, occupying a first volume of a patient's stomach and floating in the patient's stomach; and a second means for, upon inflation, occupying a second volume of the patient's stomach adjacent to and abutting the first volume and floating in said patient's stomach; wherein the first means for occupying and floating includes a first means for receiving and retaining a gas such that the first means for occupying and floating occupies said first volume; wherein the second means for occupying and floating includes a second means for receiving and retaining a gas such that the second means for occupying and floating occupies said second volume adjacent to and abutting the first volume; wherein the first means for occupying and floating and the second means for occupying and floating are adapted to be removed after deflation through the esophagus of the patient.

21. The system of claim 20, wherein the first means for occupying and floating and the second means for occupying and floating are configured to float with without exerting pressure at any point in the stomach sufficient to cause ulceration.

22. The system of claim 21, wherein undue pressure against the stomach is avoided in part by a buoyancy provided by the gas.

23. The system of claim 20, further comprising a means for flexibly connecting the first means for occupying and floating and the second means for occupying and floating.

24. The system of claim 20, further comprising a means for producing an inflation gas through a chemical reaction.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] FIG. 1 illustrates a gastric balloon having the wall breach detections system of the present invention incorporated therein.

[0034] FIG. 2 illustrates a breast implant having the wall breach detection system of the present invention incorporated therein.

[0035] FIG. 3 illustrates a multi-layer wall structure useful for the prostheses of the present invention.

[0036] FIG. 4 illustrates a passive transponder system which may be utilized in the wall breach detection systems of the present invention.

[0037] FIG. 5 illustrates a hand-held interrogation unit useful with the systems of the present invention.

[0038] FIGS. 6A through 6I illustrate leads and connectors used in electronic stimulators having the covering breach detection system of the present invention incorporated therein.

[0039] FIGS. 7 illustrate solid device components having the wall breach detection system of the present invention incorporated therein.

DETAILED DESCRIPTION OF THE INVENTION

[0040] Referring now to FIG. 1, the gastric balloon 100 includes two electric probes. Probe 130 is on the external surface in contact with the surrounding tissues, body fluids, and contents of the stomach. Probes 130 and 110 can have any of a variety of shapes or configurations, including circular plates, lattices, films, and the like, cover all or a portion of the balloon or other device. Probe 110, shown here in a lattice configuration, provides the second probe incorporated in the wall of the balloon. The probe material could be any metal, polymer, fiber, or combination thereof, with or without any coating that can generate an electrical charge or enable flow of electric current when in contact with the stomach contents. The probes are connected electronically to the wireless transmitter 140, but are separated from each other by at least one layer of non-conductive material in the balloon wall. The transmitter can be a simple wireless signal generator triggered by an electric current or preferably is an unpowered transponder using well-established RFID technology which produces a wireless signal in response to an interrogating signal. In the intact state when the wall is not breached, components 130, 110, and 140 comprise an open electrical circuit and the transmitter is inactive, disabled, or enabled to transmit a base signal.

[0041] Referring now to FIG. 2, a breast implant 200 may be similarly formed with a lattice 210 formed within the breast wall, an external electrically conductive probe 230 formed on or over the exterior surface of the implant, and a transmitter 240 connected to both the lattice and exterior probe. In the case of breast implants filled with low conductivity materials, such as silicone gel, it may be desirable to provide conductive materials to enhance conductivity upon leakage.

[0042] As magnified in FIG. 3, the second internal probe comprises both a fine lattice 110 and a thin film configuration 112 in the wall of the balloon in between, at the minimum two layers, an outermost layer 102 and innermost layer 104. The second internal probe can be also disposed in any enclosed space in the device (not shown). In the configuration described in FIG. 1, probes 130 and 110 and transponder 140 represent one open circuit and probes 130 and 112 and transponder 140 represent a second open circuit. Each open circuit is available to power or enable the transmitter or may enable the transponder to alter a base signal.

[0043] After the balloon is deployed in the stomach, the external probe 130 is in contact with the surrounding tissue and body fluids and stomach contents. Upon a breach in the integrity of the wall, such as a tear in the outermost layer 102, the leakage of physiologic fluid or stomach contents with electrolytes into the tear forms a salt bridge that closes the circuit formed probes 130 and 112 and transponder 140. Once the circuit is closed, a toggle is switched in the transponder, which will be enabled to transmit a layer 102 breach signal. Tears through layer 106 in the balloon wall will allow leakage of physiologic fluid or stomach contents with electrolytes into the tear forming a salt bridge that closes the circuit formed probes 130 and 110 and transmitter 140. Closing this circuit switches another toggle in the transponder, which will be enabled to transmit a layer 106 breach signal.

[0044] The preferred radiofrequency identification circuit is shown schematically in FIG. 4. The circuit comprises a transmitter component 300 which includes transponder circuitry 302, typically formed as an integrated circuit, and a tuned antenna-capacitor circuit 304. An interrogator reader 310 comprises circuitry 312 including the power supply (typically a battery) demodulator circuitry, decoder circuitry, and the like. An antenna 314 is tuned so that it can communicate wirelessly with the antenna 304 of the transponder 300. Operation of this circuitry is generally conventional and provides for energizing, demodulating, and decoding signals between the external and implanted components. The transponder circuitry, however, will be modified so that the conductive elements implanted in the wall, such as film 320 and lattice 330 may enable or alter the signal emitted by the transponder when the conductive elements are bridged by body fluids or inflation medium. In the preferred embodiments described above, electrical coupling of the conductors 320 and 330 will alter the signal that is produced by the transponder 302. In that way, the patient or other user will be able to interrogate the transponder and receive a base or normal response signal when no wall breach has occurred. In the event of a wall breach, the signal emitted by the transponder will be altered so that the breach will be made evident.

[0045] An exemplary reader module 120 is shown in FIG. 5 and includes LEDs to indicate normal or on function, failure, and emergency failure. An audible the alarm 126 could also be provided to alert with beeping sounds, or sensory, such as vibrations, or preferably a combination of any or all of the above. Optionally, the detector could have different auditory, visual, sensory, or different combinations to identify the source of the detected breach, especially with more than one chemical substance used. The alarm could further indicate the seriousness of the breach. For example, when breaches are detected, the volume of the alarm would increase to a higher level.

[0046] Referring now to FIG. 6A, an electrical lead 600 with a functional conductor 650 which is useful for cardiac or neuro stimulators may be similarly formed with an electrically conductive lattice 610 embedded within an insulating covering 605, an external electrically conductive cable coil 630 attached to the exterior surface of the implant, and a transmitter 640 connected to both the lattice 610 and external coil 630. As shown in the cross section FIG. 6B, the lattice 610 is preferably formed coaxial to the conductor 650 and separated from the conductor and the surrounding environment by inner and outer annular portions of the cover 605. The cross section of FIG. 6C shows conductive probes 610 and 620 in lattice form both embedded in the covering. The cross section of FIG. 6D shows a plurality of conducting probes 610 and 620 which are embedded coaxially in the insulating covering 605. In this embodiment, a current flow enabled by electrolytes between external probe 630 and 610 or 620 or the functional conductor 650 could indicate the extent of the breach. An alternative configuration is shown as lead 601 in FIG. 6E and FIG. 6F with two functional conductors 650a and 650b connected at their ends but electrically isolated from each other along their length so that each can serve as a backup for the other. In this configuration, the probes 610 and 620 do not have to be separated from but are in contact with the functional conductors.

[0047] In the case of detecting a breach of the functional conductor, a lead 602 is shown with two electrically conductive probes 660 and 670 coupled to two ends of the functional conductor 650, as shown in FIG. 6G.

[0048] In the case where the functional conductor 650 is connected to another functional electrical conductor 680, as shown in FIG. 6H, a lead 603 is shown with a transmitter 640 with two probes, 660 and 670. Probe 660 is coupled to the functional conductor 650 and 670 to the other functional conductor 680, in this embodiment an electrical connector. One or both of the probes 660 and 670 are attached after the connection is made. Both probes 660 and 670 can be embedded in the functional conductor connection housing in either the male or female side, as shown in FIG. 6I. In this embodiment of a female connector 604, functional conductor 650 passes through and is electrically coupled to functional conductor 680. In this embodiment as electrically isolated rings inside the female connector 604, probe 670 is coupled to 680 and probes 660a and 660b coupled to 650. Such a configuration would enable detection of a partial detachment of the male member 649 when the circuit between 670 and 660b is closed but that between 660a and 660b is open and a possible complete lead detachment when all the detection circuits are open. The placement and physical length of the probes 660a and 660b would determine the amount of detachment necessary to open the circuit and enable the system to signal a breach.

[0049] While the leads and connectors incorporating the detection system are illustrated independently above, they may be configured independent to each other in a device system or together in any combination using one or more common detecting or signaling circuits.

[0050] Referring now to FIG. 7, two solid prosthetic device forms are shown. Cylindrical shaped 701 and a flat triangular shaped 702 are shown with a transmitter 740, an electrically conductive lattice 710, and an external electrically conductive probe 730. 701a and 702a are cross sections of each respectively. Any wear and tear or fracture deep to the lattice 710 is detected as a breach. It can be appreciated that the principle can be applied to a solid object of any shape. In the case of an object holding other parts of the device in place or within a range of motion (not shown), such as functioning like a ligamentous or cartilagecartilaginous structure in the body, respectively, detecting a breach of the object would indicate a potential dislocation of the other parts.

[0051] While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.