Title:
Apparatus and method for remote deflation of intragastric balloon
Kind Code:
A1


Abstract:
An intragastric balloon and apparatus for remote deflation of the balloon are disclosed. The apparatus for remote deflation allows the physician to cause the valve of the intragastric balloon to open without surgery using a remote control from outside of the body. The remote deflation mechanism may be powered internally by a battery or may be powered externally by induction. Additionally, a deflation mechanism that causes the entire valve to be separated from the intragastric balloon is disclosed.



Inventors:
Birk, Janel A. (Oxnard, CA, US)
Application Number:
11/735194
Publication Date:
10/16/2008
Filing Date:
04/13/2007
Assignee:
ALLERGAN, INC. (Irvine, CA, US)
Primary Class:
International Classes:
A61M29/00
View Patent Images:
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Primary Examiner:
DAULT, RICHARD DOUGLAS
Attorney, Agent or Firm:
ALLERGAN, INC. (2525 DUPONT DRIVE, T2-7H, IRVINE, CA, 92612-1599, US)
Claims:
I claim:

1. An inflatable intragastric balloon useful for facilitating weight loss in a patient in need thereof and suitable for remote deflation comprising: a shell for containing a volume of fluid introduced therein; a valve for adjusting the volume of fluid in said shell; a remotely-activated deflation mechanism for emptying the volume of fluid in said shell; and a remote control for communicating with said remotely-activated deflation mechanism from outside the patient's body.

2. The intragastric balloon of claim 1, wherein said remotely-activated deflation mechanism comprises a meltable sealing plug.

3. The intragastric balloon of claim 1, wherein said remotely-activated deflation mechanism comprises a shape memory element, wherein application of heat to said shape memory element causes said shape memory element to deform.

4. The intragastric balloon of claim 1 further comprising a quick fill valve.

5. The intragastric balloon of claim 1, wherein said shell comprises at least one of the following materials: diphenyl silicone, PTFE, silicone-polyurethane elastomer, HDPE, LDPE, or parylene coating.

6. The intragastric balloon of claim 3, wherein said shape memory element comprises a shape memory alloy.

7. The intragastric balloon of claim 6, wherein said shape memory element comprises NiTiNOL.

8. The intragastric balloon of claim 3, wherein said shape memory element comprises a shape memory polymer.

9. The intragastric balloon of claim 1, wherein said remotely-activated deflation mechanism further comprises a battery for powering said remote deflation mechanism.

10. The intragastric balloon of claim 1, wherein said remotely-activated deflation mechanism further comprises microelectronics for controlling said remote deflation mechanism.

11. The intragastric balloon of claim 1, wherein said remotely-activated deflation mechanism is powered by induction from outside the patient's body.

12. The intragastric balloon of claim 3, wherein said shape memory element comprises a cutting wire, wherein application of heat to said shape memory element causes said cutting wire to deform, thereby forming an opening in said shell.

13. The intragastric balloon of claim 10, wherein said shape memory element further comprises a plug proximate said cutting wire, wherein upon application of heat, said cutting wire deforms to open said plug.

14. The intragastric balloon of claim 3, wherein said shape memory element comprises a spring and a plug detachably mounted thereto, wherein upon application of heat said spring deforms to open said plug.

15. The intragastric balloon of claim 3, wherein said shape memory element comprises an actuator, and said remotely-activated deflation mechanism comprises a spring collar and an obstruction for holding said spring collar in a first position, and a slit valve, wherein upon application of heat said actuator deforms to eject said obstruction, thereby causing said spring collar to move to a second position in which said slit valve opens.

16. The intragastric balloon of claim 1, wherein the valve is in a self-contained capsule that may be ejected by a remotely-activated deflation mechanism.

17. A method for the in vivo remote deflation and removal from a mammalian body of an intragastric balloon containing a volume of fluid therein comprising the steps of: remotely activating a deflation mechanism to create an opening in the shell; allowing normal intragastric movements to drain fluid from the balloon; and allowing the deflated balloon to pass through the body.

Description:

BACKGROUND OF INVENTION

1. Field of the Invention

The present invention is directed to devices and methods that enable remote deflation of intragastric balloons used for the treatment of obesity, and in particular devices and methods that enable an implanted intragastric balloon to be remotely deflated while the device itself is in the stomach.

2. Description of the Related Art

Intragastric balloons are well known in the art as a means for treating obesity. One such inflatable intragastric balloon is described in U.S. Pat. No. 5,084,061 and is commercially available as the BioEnterics Intragastric Balloon System (sold under the trademark BIB®). These devices are designed to provide therapy for moderately obese individuals who need to shed pounds in preparation for surgery, or as part of a dietary or behavioral modification program.

The BIB System, for example, consists of a silicone elastomer intragastric balloon that is inserted into the stomach and filled with fluid. Commercially available intragastric balloons are filled with saline solution or air. The intragastric balloon functions by filling the stomach and enhancing appetite control. Placement of the intragastric balloon is non-surgical, usually requiring no more than 20-30 minutes. The procedure is performed gastroscopically in an outpatient setting, typically using local anesthesia and sedation. Placement is temporary, and intragastric balloons are typically removed after six months.

Most intragastric balloons utilized for this purpose are placed in the stomach in an empty or deflated state and thereafter filled (fully or partially) with a suitable fluid. The balloon occupies space in the stomach, thereby leaving less room available for food and creating a feeling of satiety for the patient. Clinical results with these devices show that for many obese patients, the intragastric balloons significantly help to control appetite and accomplish weight loss.

Intragastric balloons typically are implanted for a finite period of time, usually lasting approximately six months. This time period may be shortened by a treating physician who wishes to alter the patient's treatment and remove the balloon prior to the six month period. In any event, at some point after the balloon has been surgically placed in the stomach, it will become desirable to remove the balloon from the stomach. One of the means of removing the balloon is to deflate it by puncturing the balloon, and either aspirating the contents of the balloon or allowing the fluid to pass into the patient's stomach. This means of removing saline from the balloon requires surgical intervention, through the use of a gastroscopic instrument. When the balloon is deflated in this manner, the balloon itself may be surgically removed using the gastroscopic instrument.

Alternatively, if the balloon is left in place beyond its designed lifetime, the acids present in a patient's stomach may erode the balloon to the point where it self-deflates. When this occurs, the deflated balloon may pass naturally through the patient's digestive system and be expelled through the bowel.

Those experienced in the art will readily appreciate that manipulating the balloon in situ in order to deflate the balloon can be difficult. This is because the balloon is slippery and positionally unstable. The usually spherical or ellipsoidal intragastric balloons may readily rotate in the stomach, making it difficult for a surgeon to manipulate the balloon in order to find a deflation valve, or to safely puncture the balloon using a surgical instrument.

It may become desirable, then, particularly when the balloon is to be removed from the body, to cause the deflation of the balloon remotely without surgical intervention.

Therefore, the present invention is directed at overcoming the problems associated with the prior art systems. These and other objects of the present invention will become apparent from the further disclosure to be made in the detailed descriptions given below.

SUMMARY OF THE INVENTION

The present invention addresses the above-described problems by providing apparatuses and methods for the remote deflation of an intragastric balloon. The present invention allows a physician to remotely deflate an intragastric balloon from outside the body, utilizing a remote control that triggers the deflation with an activation signal.

In one preferred embodiment, the apparatus of the present invention includes a meltable wax plug that melts to cause the opening of a valve. Upon receipt of an activation signal sent by the physician from a remote control outside the body, the microelectronics contained in the valve assembly cause the temperature of heating element(s) contained within the valve to melt the wax plug. Once the wax plug has melted, thus causing the balloon valve to open, the normal movements of the stomach cause the fluid contained within the balloon to empty from the balloon, causing deflation. The patient is able to then pass the balloon.

In another preferred embodiment, the apparatus of the present invention includes a remote deflation valve having a shape memory element spring that holds a plug in place, thus sealing the valve of the intragastric balloon. The shape memory element spring may be heated remotely by induction, or the deflation mechanism may include microelectronics to cause heating of the spring. As the spring changes shape as a result of the application of heat, it removes the plug, thus causing the balloon to unseal. The fluid contained in the balloon may then flow freely out of the balloon, thus causing the balloon to deflate. The patient is then able to safely pass the deflated balloon.

According to yet another embodiment of the present invention, the intragastric balloon includes a remote deflation mechanism with a shape memory element actuator, a spring collar, an obstruction that holds the spring collar in place and a slit valve. As with the other embodiments disclosed, the shape memory element actuator may be heated remotely by induction or may alternatively include microelectronics and heating elements contained within the deflation mechanism. When the deflation mechanism is activated, the actuator pushes the obstruction out of the valve, thus allowing the spring collar to contract. The contraction of the spring collar causes the slit valve to open, which allows fluid contained in the balloon to flow out of the balloon and drain accordingly. The patient is then able to pass the deflated balloon.

In another preferred embodiment of the present invention, a shape memory element “cutting wire” is employed in the remote deflation mechanism. In this embodiment, when heat is applied to the shape memory alloy wire contained within a remote deflation valve, the wire changes shape, causing the wire to cut through a wax (or other suitable material, e.g. plastic or polymer) plug that seals the valve. Once the wax plug has been cut from the valve, fluid is able to freely flow through the valve, thus allowing the balloon to drain and pass from the body.

In still yet another preferred embodiment of the present invention, the remote deflation mechanism of the intragastric balloon includes a wire that surrounds the valve. The wire is used to break the bond between the valve and the balloon. When the bond between balloon and the valve is broken, the valve separates from the balloon, and fluid flows freely from the balloon. This preferred embodiment has the added benefit that the balloon and valve assembly may pass through the body separately, thus allowing passage to occur more easily, as the device is in two separate pieces. These and various other aspects of the invention, and its advantages, will be discussed in more detail below.

In another embodiment, the valve could be contained in a cylindrical capsule (taking the shape of a large pill, for example) that fits within a collared opening of the balloon shell to create a seal. The collared opening could include a spring or other such mechanism that would retain the size and shape of the collar. When the remote deflation mechanism is activated, the spring is released, thereby opening the collar and ejecting the cylindrical capsule from the balloon, rendering two separate components that could then easily pass through the gastrointestinal track. Alternatively, the collared opening could include a heating element, which when the remote deflation mechanism is activated, would cause the seal between the capsule and the collar to break, thereby ejecting the cylindrical capsule from the balloon. As yet a further alternative, the cylindrical capsule could contain a mechanism such as a spring (a torsional spring, for example), that retains the shape and size of the capsule, holding the capsule in place within the collared opening of the balloon shell. When the remote deflation mechanism is activated, the torsional spring collapses, causing the capsule to be ejected from the balloon.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevated side view of an intragastric balloon of the present invention.

FIG. 2a is a side cut-away view of a remote deflation valve according to one embodiment of the present invention, which shows the valve in the “closed” position.

FIG. 2b is a side cut-away view of the remote deflation valve of FIG. 2a shown in the “open” position.

FIG. 3a is a side cut-away view of a remote deflation valve according to a further embodiment of the present invention, which shows the valve in the “closed” position.

FIG. 3b is a side cut-away view of the remote deflation valve of FIG. 3a shown in the “open” position.

FIG. 4a is a side view of a remote deflation valve according to yet a further embodiment of the present invention, which shows the valve in the “closed” position.

FIG. 4b is a side cut-away view of the remote deflation valve of FIG. 4a shown in the “open” position.

FIG. 5a is a side view of the remote deflation valve of FIG. 4a which shows the valve in the “closed” position.

FIG. 5b is a side view of the remote deflation valve of FIG. 4b shown in the “open” position.

FIG. 6a is a side cut-away view of a remote deflation valve according to still a further embodiment of the present invention, which shows the valve in the “closed” position.

FIG. 6b is a side cut-away view of the remote deflation valve of FIG. 6a shown in the “open” position.

FIGS. 7a and 7b show a top view of an embodiment of the wire cutting mechanism of the remote deflation valve of FIGS. 6a and 6b.

FIGS. 7c and 7d show a further embodiment of the wire cutting mechanism of the remote deflation valve of FIGS. 6a and 6b.

FIG. 8a shows an elevated side view of an intragastric balloon of the present invention with a deflation mechanism surrounding the valve prior to the deflation mechanism being activated.

FIG. 8b shows an elevated side view of FIG. 8a after the deflation mechanism has been activated.

FIG. 9 is a front view of a remote control for activating a remote deflation valve according to the present invention.

FIG. 10a is a side cut-away view of a remote-deflating intragastric balloon according to still a further embodiment of the present invention, which shows the balloon in the “closed” position.

FIG. 10b is a side cut-away view of the remote-deflating intragastric balloon of FIG. 10a shown in the “open” position.

FIG. 11 is a side cut-away view of a remote-deflating intragastric balloon according to still a further embodiment of the present invention, which shows the balloon in the “closed” position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is directed to a method and device for remotely deflating an intragastric balloon without requiring surgical intervention.

Referring to FIGS. 1-2b, the intragastric balloon according to one preferred embodiment of the present invention is shown. The intragastric balloon 10 includes a shell 12, fill valve 14, and remote deflation valve 16.

During implantation, an un-inflated balloon 10 may be positioned in the stomach in a desired location. Once the balloon is positioned, it may be inflated using fill valve 14, and those experienced in the art will appreciate that there are several different methods for inflating the balloon, such as disclosed in commonly assigned International Application Number PCT U.S. 03/19414, entitled “Two Way Slit Valve”, the disclosure of which is incorporated in its entirety herein by reference.

After implantation, it may become desirable to remove the balloon. In order to remove the balloon it must first be deflated. Once deflated, the balloon may be allowed to naturally pass through the body upon deflation, or alternatively the balloon may be surgically removed using a minimally invasive gastroscopic procedure. The present invention is designed such that the deflated intragastric balloon and integrated remote deflation valve may naturally pass through the human body.

Referring to FIGS. 2a and 2b, a preferred embodiment of the remote deflation valve of the present invention is shown. Remote deflation valve 16 is comprised of sealing plug 30, heating element(s) 31, microelectronic control 32 and power source 33. The power source 33 may be a battery, capacitor, induction coil, kinetic energy creation by body motion stored onto a capacitor, fuel cell, power source powered by chemistry of the body, or a power source powered by temperature change. The sealing plug 30 is preferably formed of suitable medical-grade wax, such as paraffin, or may also be a lower temperature melt polymer. Any type of suitable medical-grade wax, such as paraffin, may be used for sealing plug 30.

At the time the physician desires to deflate the balloon, the patient may be brought into the physician's office in an outpatient setting. In order to open deflation valve 16, the physician activates the valve opening mechanism remotely and from outside the body, using a remote control 100 such as that depicted in FIG. 9. The physician holds remote control 100 near the stomach of the patient, and upon depression of button 101, remote control 100 sends an activation signal, which my be comprised of radio waves, sonic waves, or any other waves suitable for transmitting a small activation signal through the tissue of the abdominal cavity to the implanted balloon.

Microelectronic control 32 has an antenna (not shown) for receiving the activation signal from remote control 100. Upon receiving the activation signal, microelectronic control uses power from power source 33 to begin increasing the temperature of the heating element(s) 31. A metal film heating element, utilizing metals (such as nichrome, stainless steel, copper, gold, etc.) can be used for heating element(s) 31. As the temperature of the heating element(s) 31 begins to increase, the sealing plug 30 begins to melt. Ideally, the melting point of the sealing plug will be slightly above the temperatures in the stomach to ensure that the valve stays closed in its normal operating environment.

As the sealing plug begins to melt, it is expelled into the stomach and/or collects on wicking surfaces 34, which may be composed of a contoured reservoir. Ideally the wax will melt and be expelled into the stomach for rapid quench cooling and passage through the intestines. The collection of the wax or other sealing material on wicking surfaces 34 prevents it from clogging capillaries 35 and allows the fluid contained within intragastric balloon 10 to flow out of the balloon. Once the sealing plug is completely melted and been expelled into the stomach and/or collected on wicking surfaces 34, capillaries 35 allow the free flow of the fluid contained inside the balloon through valve opening 36 (FIG. 2b). Through the normal movements and contraction of the stomach walls, the balloon will drain of the fluid contained inside and shrink down to a size that is passable through the body. The microelectronics, heating element, and power source are safely contained within the valve structure such that they do not present any danger to the patient.

In addition to performing the function of controlling the heating element for the melting of the sealing plug, the microelectronic control 32 may communicate with the remote control 100 to confirm that the deflation mechanism has been activated. Following receipt of a confirmation signal, the physician and patient may then track the progress of the passing of the device.

Referring to FIGS. 3a and 3b, another preferred embodiment of the remote deflation valve of the present invention is shown. Remote deflation valve 26 is comprised of a shape memory spring 41, plug 42, and capillaries 43. While NiTiNOL is the preferred material for the spring utilized in the present invention, any number of shape memory alloys or polymers, or spring materials, including steels (such as stainless steel, chromium, titanium, etc.), may be used.

As with the valve mechanism discussed in the previous embodiment, at the time the physician desires to deflate the balloon, the patient may be brought into the physician's office in an outpatient setting.

In order to open deflation valve 26, the physician activates the deflation mechanism from outside the body, using a remote control (not shown). The spring may be heated remotely by induction from the remote control, or may alternatively include microelectronics for receiving an activation signal and controlling heating elements similar to those described in the previous embodiment.

Irrespective of the method of activation, when the spring 41 is heated, it contracts, pulling the plug 42 out of its resting place and into reservoir 44. This causes channel 45 to open, thus allowing the fluid contained in the balloon to flow through the capillaries 43 and open channel 45, out of the balloon. FIG. 3b shows the valve mechanism in its open position. Because of pressure normally exerted on the balloon by the stomach, the fluid contained therein will flow freely through the capillaries and open channel and into the stomach, thus causing the balloon to deflate. The deflated intragastric balloon is then allowed to pass out of the body.

As an alternative to having a shape memory spring permanently fixed to a plug, the spring may be detachably fixed to a plug comprised of wax or some other similar biodegradable material. In this way, when the spring is heated and changes shape, it may be used to eject the biodegradable plug into the stomach, thus allowing the balloon to drain. The deflated intragastric balloon would then be allowed to pass out of the body.

Referring to FIGS. 4a, 4b, 5a, and 5b, another preferred embodiment of a remote deflation valve of the present invention is shown. FIGS. 4a and 4b show a cutaway side view of remote deflation valve 56, while FIGS. 5a and 5b show the same valve in a side view. Remote deflation valve 56 is comprised of a shape memory actuator 61, obstruction 62, slit valve 63 and spring collar 64. As previously discussed, while NiTiNOL is the preferred material for the actuator of the present invention, any number of shape memory alloys or polymers may be used.

In order to open deflation valve 56, the physician activates the valve opening mechanism remotely and from outside the body, using remote control 100. The actuator 61 may be heated remotely by induction or alternatively the remote deflation valve may include microelectronics and heating elements.

Irrespective of the method of activation, the actuator 61, when activated, pushes obstruction 62 out of the valve opening. When in place, obstruction 62 serves to prevent the slit valve 63 from opening by causing spring collar 64 to be held in its open position, as shown in FIGS. 4a and 5a. Once the obstruction 62 is removed from the valve opening, spring collar 64, which is located below the slit valve 63, contracts. The contraction of spring collar 64 causes the slit valve 63 to be opened, as shown in FIG. 4b and 5b. With the slit valve 63 now open, the fluid contained in the balloon may flow through channel 65 and out through the slit valve opening 66. Again, because the intragastric balloon is under pressure, and due to the normal movements of the stomach, the fluid contained therein will flow freely through open slit valve 63 and into the stomach, thus causing the balloon to deflate. The deflated intragastric balloon is then allowed to pass out of the body.

Referring to FIGS. 6a and 6b, an interior cutaway view of another preferred embodiment of the remote deflation valve of the present invention is shown. Remote deflation valve 76 is comprised of a shape memory alloy cutting wire mechanism 81, sealing plug 82, and capillary 83. NiTiNOL is used in this preferred embodiment, however, any number of suitable shape memory alloys may be used.

As with the previous embodiments discussed, in order to open valve 76, the physician activates the valve opening mechanism remotely and from outside the body, using remote control 100 (FIG. 9). In this embodiment, the remote deflation valve 76 includes microelectronics (not shown), a battery or other power source (not shown) and heating element(s) 85 (FIGS. 7a-7d) for heating the shape memory alloy cutting wire 84 (FIGS. 7a-7d). As with the previous embodiments discussed, however, the shape memory alloy cutting wire may be heated by induction.

FIGS. 7a, 7b, 7c, and 7d show top views of the cutting wire mechanism 84. As heat is applied by the heating elements, the shape memory element begins to change shape. FIG. 7a shows the shape memory element cutting wire 84 prior to the application of heat. Prior to the application of heat, the shape memory element cutting wire 84 is in a curved L-shape, with the curved portion resting around the outside of wax plug 82. As an alternative to the L-shaped shape memory element cutting wire 84 of FIG. 7a, the cutting wire may also be in a loop shape that completely encircles the wax plug, as is shown in FIG. 7c.

In this embodiment, the shape memory element cutting wire mechanism 81 is activated by a signal received from remote control 100 (FIG. 9). Upon receiving the activation signal, the microelectronic control (not shown) uses power from the power source (not shown) to begin increasing the temperature of heating element(s) 85. As the shape memory element cutting wire 84 begins to change shape as a result of the application of heat, it slices through the sealing plug 82. FIGS. 7b and 7d show the shape memory alloy cutting wire 84 in its post-heat application deformed shape, having cut through the sealing plug 82. FIG. 7a shows a shape memory alloy cutting wire in an L-shaped configuration, while FIG. 7c shows a shape memory alloy cutting wire in a loop shaped configuration.

With the sealing plug 82 having been severed from the valve, the capillary 83 (FIG. 6b) is now open to allow fluid contained within the intragastric balloon to escape the balloon. Again, because the intragastric balloon is under pressure and due to the normal movements of the stomach, the fluid contained in the balloon will flow freely through the capillary and into the stomach, thus causing the balloon to deflate. The deflated intragastric balloon is then allowed to pass out of the body.

Referring to FIGS. 8a and 8b, another preferred embodiment of an intragastric balloon of the present invention incorporating a remote deflation mechanism is shown. Intragastric balloon 90 is comprised of shell 97, valve 91, valve/balloon bond 92, heating elements 93, cutting wire 94, microelectronic control 95, and power source 96.

Rather than using a remote deflation mechanism to open the valve of the intragastric balloon, the embodiment of the present invention shown in FIGS. 8a and 8b utilizes a deflation mechanism for separating the entire valve from the remaining portion of the balloon.

Similar to the procedures described above, at the time the physician desires to deflate the balloon, the patient may be brought into the physician's office in an outpatient setting. In order to cause the intragastric balloon 90 to deflate, the physician activates the valve opening mechanism remotely and from outside the body, using a remote control 100 (FIG. 9). The physician holds remote control 100 near the stomach of the patient, and upon depression of a button, remote control 100 sends an activation signal to the microelectronic control 95.

Microelectronic control 95 has an antenna (not shown) for receiving the activation signal from remote control 100. Upon receiving the activation signal, microelectronic control uses power from power source 96 to begin increasing the temperature of heating element(s) 93. Similar to the embodiments discussed above that incorporate heating elements, metal film heating elements utilizing materials such as nichrome, stainless steel, copper, gold, or other such materials, can be used for heating element(s) 93. As the temperature of heating element(s) 93 begin to increase, the temperature of cutting wire 94 also begins to increase. The increased temperature of the cutting wire causes the valve/balloon bond 92 to deteriorate, resulting in separation of the valve 91 from shell 97.

Once the valve/balloon bond 92 is broken and the valve is separated from the shell, fluid contained inside the balloon freely flows through the opening 98 that is created by the separation of the two portions. Through the normal movements and contraction of the stomach walls, the balloon will drain of the fluid contained inside and shrink down to a size that is passable through the human body. The microelectronics, heating element(s) and power source are safely contained within the valve structure such that they do not present any danger to the patient. Because the entire intragastric balloon may now be in two separate pieces—an empty shell and a self-contained valve assembly—the passing of the balloon and valve is facilitated.

As with the previous embodiments described, in addition to performing the function of controlling the heating elements, the microelectronic control 95 may communicate with the remote control 100 to confirm that the deflation mechanism has been activated. Following receipt of a confirmation signal, the physician and patient may then track the progress of the passing of the device.

Referring to FIGS. 10a and 10b, another preferred embodiment of an intragastric balloon of the present invention incorporating a remote deflation mechanism is shown. Intragastric balloon 109 is comprised of shell 110 and valve capsule 111. Valve capsule 111 is comprised of valve 112, shape memory torsional spring 113, and combined microelectronic control and power source 115. FIG. 10a also shows adjustment tool 121 for adjusting the volume of the intragastric balloon 109.

Rather than using a remote deflation mechanism to open the valve of the intragastric balloon, the embodiment of the present invention shown in FIGS. 10a and 10b utilizes a deflation mechanism for separating the entire valve capsule from the remaining portion of the balloon. When inflated, the valve capsule 111 is held tightly in the balloon collar 114 by pressure exerted by shape memory torsional spring 113, creating a seal between the valve capsule and the balloon collar.

Similar to the various procedures described above, at the time the physician desires to deflate the balloon, the patient may be brought into the physician's office in an outpatient setting. In order cause the intragastric balloon 109 to deflate, the physician activates the valve opening mechanism remotely and from outside the body, using a remote control 100 (FIG. 9). The physician holds remote control 100 near the stomach of the patient, and upon depression of a button, remote control 100 sends an activation signal to the combined microelectronic control and power source 115.

Combined microelectronic control and power supply 115 has an antenna (not shown) for receiving the activation signal from remote control 100. Upon receiving the activation signal, combined microelectronic control and power source uses power to begin increasing the temperature of heating element(s) (not shown) that are connected to the torsional spring 113. Similar to the embodiments discussed above that incorporate heating elements, metal film heating elements utilizing materials such as nichrome, stainless steel, copper, gold, or other such materials, can be used for the heating element(s). As the temperature of the heating element(s) begin to increase, the temperature of shape memory torsional spring 113 also begins to increase, thereby causing the spring to deform and reduce in diameter. As the diameter decreases, the seal between valve capsule 111 and balloon collar 114 is broken.

Once the seal between the balloon collar 114 and valve capsule 111 is broken and the valve capsule is separated from the shell, fluid contained inside the balloon freely flows through the opening 116 (FIG. 10b) that is created by the separation of the two portions. Through the normal movements and contraction of the stomach walls, the balloon will drain of the fluid contained inside and shrink down to a size that is passable through the human body. The combined microelectronic control and power supply and heating element(s) are safely contained within the valve capsule such that they do not present any danger to the patient. Because the entire intragastric balloon may now be in two separate pieces—an empty shell and a self-contained valve capsule—the passing of the balloon and valve is facilitated.

As with the previous embodiments described, in addition to performing the function of controlling the heating elements, the combined microelectronic control and power supply 115 may communicate with the remote control 100 to confirm that the deflation mechanism has been activated. Following receipt of a confirmation signal, the physician and patient may then track the progress of the passing of the device.

Referring to FIG. 11, another preferred embodiment of an intragastric balloon of the present invention incorporating a remote deflation mechanism is shown. Intragastric balloon 129 is comprised of shell 130 and valve capsule 131. Valve capsule 131 is comprised of valve 132, and combined microelectronic control and power source 135. Shell 130 is comprised of a collar 136, heating element 137, and shape memory cutting element 138. FIG. 11 also shows adjustment tool 141 for adjusting the volume of the intragastric balloon 129.

As with several of the other embodiments previously discussed, rather than using a remote deflation mechanism to open the valve of the intragastric balloon, the embodiment of the present invention shown in FIG. 11 utilizes a deflation mechanism for separating the entire valve capsule from the remaining portion of the balloon. When inflated, the valve capsule 131 is held tightly in the balloon collar 114 by pressure exerted by shape memory element 138, creating a seal between the valve capsule and the balloon collar.

Similar to the various procedures described above, at the time the physician desires to deflate the balloon, the patient may be brought into the physician's office in an outpatient setting. In order cause the intragastric balloon 129 to deflate, the physician activates the valve opening mechanism remotely and from outside the body, using a remote control 100 (FIG. 9). The physician holds remote control 100 near the stomach of the patient, and upon depression of a button, remote control 100 sends an activation signal to the combined microelectronic control and power source 135.

Combined microelectronic control and power supply 135 has an antenna (not shown) for receiving the activation signal from remote control 100. Upon receiving the activation signal, combined microelectronic control and power source uses power to begin increasing the temperature of heating element(s) 137 that are connected to the shape memory cutting element 138. Similar to the embodiments discussed above that incorporate heating elements, metal film heating elements utilizing materials such as nichrome, stainless steel, copper, gold, or other such materials, can be used for the heating element(s). As the temperature of the heating element(s) begin to increase, the temperature of shape memory cutting element 138 also begins to increase, thereby causing the cutting element to cut through the balloon collar 136. With the balloon collar 136 completely cut, the seal between valve capsule 131 and balloon collar 136 is broken.

Once the seal between the balloon collar 136 and valve capsule 131 is broken and the valve capsule is separated from the shell, fluid contained inside the balloon freely flows through the opening that is created by the separation of the two portions. Through the normal movements and contraction of the stomach walls, the balloon will drain of the fluid contained inside and shrink down to a size that is passable through the human body. The combined microelectronic control and power supply and heating element(s) are safely contained within the valve capsule such that they do not present any danger to the patient. Because the entire intragastric balloon may now be in two separate pieces—an empty shell and a self-contained valve capsule—the passing of the balloon and valve is facilitated. As an alternative to the cutting mechanism described herein, the remote deflation mechanism may be comprised of a mechanical system (such as a torsional spring) contained within the collar which holds the valve capsule in place until the balloon deflation mechanism is initiated.

As with the previous embodiments described, in addition to performing the function of controlling the heating elements, the combined microelectronic control and power supply 135 may communicate with the remote control 100 to confirm that the deflation mechanism has been activated. Following receipt of a confirmation signal, the physician and patient may then track the progress of the passing of the device.

To ensure the device of the present invention will pass easily, the intragastric balloon of the present invention may be constructed of a very thin, highly acid-resistant shell material. In addition, the intragastric balloon may be shaped to encourage collapse into a bullet shape for smooth passage through the intestines. This shape may be created by pre-formed convolutions in the shell that would expand into a substantially spherical or ellipsoidal shape when inflated, but would retract into its small collapsed shape when the remote deflation mechanism was triggered.

The remote control will take the form of a handheld control unit that may feature an LCD display and/or similar type of display and a control panel, such as a keyboard or touchscreen, to operate the device. The remote control may feature a series of menus that allow an operator to program (or read/determine) the microelectronics to contain in memory important information such as the intragastric balloon's size, patient's name, implanting physician, and the date it was implanted. The remote control may communicate with the sensor via telemetry through radiowaves. The FDA and globally recognized communications band (WMTS 402-405 Mhz) may be used in some embodiments, and an authentication process (e.g., digital handshake signal, PIN verification, or other similar verification process) can be used to ensure that the device cannot be accidentally accessed or controlled by another control mechanism other than the remote control. The telemetry control signal can be sent from approximately a foot or possibly a greater distance from the patient and will typically not require the patient to disrobe to query the sensor or to change its parameters. The remote control is preferably able to read and write information to the microelectronics contained in the intragastric balloon. The remote control may also be password controlled to prevent unauthorized personnel from querying the device. The display of the remote control, which may include visual and audio outputs, typically will display or output the sensed parameter of the remote deflation valve's condition or physical parameter whether this parameter is “open”, “closed”, or any other physical parameter that the remote control is adjusted to monitor.

EXAMPLES

The following examples describe various procedures using the method and device of the present invention.

Example 1

Remote Deflation of an Intragastric Balloon Containing a Sealing Plug

In this example, the patient is an overweight male who has previously had an intragastric balloon inserted into his stomach. The intragastric balloon has been implanted for a full course of treatment for six months, and the surgeon is prepared to remove the balloon.

The removal of the balloon is performed in an outpatient setting at the doctor's office. Reference is made to FIGS. 2a and 2b for the remote deflation valve utilized in this example.

In order to open deflation valve 16, the physician activates the remote deflation mechanism from outside the body using a remote control 100, such as that depicted in FIG. 9. The physician holds remote control 100 near the stomach of the patient, and upon depression of a button, remote control 100 sends an activation signal through the patient's tissue to the microelectronic control 32.

Upon receiving the activation signal, microelectronic control 32 uses power from a battery 33 to begin increasing the temperature of heating element(s) 31. As the temperature of heating element(s) 31 begins to increase, the wax plug 30 begins to melt.

As the wax begins to melt, it collects on wicking surfaces 34. The collection of the wax on wicking surfaces 34 prevents the wax from clogging capillaries 35 and allows the fluid contained within intragastric balloon 10 to flow out of the balloon. Once the wax is melted and collected on wicking surfaces 34, capillaries 35 allow the free flow of the fluid contained inside the balloon through valve opening 36. In addition, once the wax is melted, the microelectronic control 32 sends a confirmation signal to the remote control 100, informing the doctor and patient that the deflation device has been activated.

Through the normal movements and contraction of the stomach walls, the balloon drains of the saline contained inside and shrinks down to a size that is passable through the human body. The microelectronics, heating elements, and battery are safely contained within the valve structure such that they do not present any danger to the patient.

Having received the confirmation signal, the patient may now leave the doctor's office and return home. The patient tracks the passage of the intragastric balloon and informs the doctor when it has passed.

Example 2

Remote Deflation of an Intragastric Balloon Containing a Separable Valve

In this example, the patient is an overweight female who has previously had an intragastric balloon implanted. After implantation the patient has experienced significant undesired side effects resulting from the implantation, including nausea, vomiting, and general abdominal discomfort. Therefore, the patient desires to have the remote deflation mechanism activated, thus allowing the balloon to be passed.

As with the first example, the balloon removal is performed in an outpatient setting at the doctor's office. Reference is made to FIGS. 8a and 8b for the remote deflation mechanism utilized in this example.

In order to cause the intragastric balloon 90 to deflate, the physician activates the remote deflation mechanism using a remote control 100, such as that depicted in FIG. 9. The physician positions remote control 100 near the stomach of the patient, and upon depression of a button, remote control 100 sends an activation signal through the tissue of the abdominal cavity to the microelectronic control 95.

Microelectronic control 95 has an antenna for receiving the activation signal from remote control 100. Upon receiving the activation signal, microelectronic control uses power from battery 96 to begin increasing the temperature of heating element(s) 93. As the temperature of heating element(s) 93 begins to increase, the temperature of cutting wire 94 also begins to increase. The increased temperature of the cutting wire causes the valve/balloon bond 92 to deteriorate, resulting in separation of the valve 91 from shell 97.

As the valve/balloon bond 92 breaks and separates from the shell, the normal movements of the stomach cause the fluid contained inside the balloon to freely flow through the opening 98. The normal movements and contraction of the stomach walls cause the intragastric balloon to completely drain of the fluid contained inside and shrink down to a size that is passable through the human body. The microelectronics, heating elements and battery are safely contained within the valve structure such that they do not present any danger to the patient. Because the entire intragastric balloon may now comprise two separate pieces, the passing of the balloon and valve is facilitated.

Once the valve/balloon bond has been broken, the microelectronic control 95 sends a confirmation signal to remote control 100 to confirm that the deflation mechanism has been activated. Following receipt of a confirmation signal by the remote control, the procedure is complete and the patient can return home and wait until the shell and valve assembly pass through the system. The patient tracks the passage of the intragastric balloon and informs the doctor when its has passed.

Although the invention has been described and illustrated with a certain degree of particularity, it is understood that the present disclosure has been made only by way of example, and that numerous changes in the combination and arrangement of parts can be resorted to by those skilled in the art without departing from the spirit and scope of the invention, as hereinafter claimed.

Example 3

Remote Deflation of an Intragastric Balloon Containing a Valve Capsule

In this example, the patient is an overweight male who has previously had an intragastric balloon inserted into his stomach. The intragastric balloon has been implanted for a full course of treatment for six months, and the surgeon is prepared to remove the balloon.

The removal of the balloon is performed in an outpatient setting at the doctor's office. Reference is made to FIGS. 10a and 10b for the remote deflation valve utilized in this example.

In order to deflate balloon 109, the physician activates the remote deflation mechanism from outside the body using a remote control 100, such as that depicted in FIG. 9. The physician holds remote control 100 near the stomach of the patient, and upon depression of a button, remote control 100 sends an activation signal through the patient's tissue to the combined microelectronic control and power source 115.

Upon receiving the activation signal, the combined microelectronic control and power source 115 uses power to begin increasing the temperature of heating element(s) (not shown) that are connected to the torsional spring 113. As the temperature of the heating element(s) begin to increase, the temperature of shape memory torsional spring 113 also begins to increase, thereby causing the spring to deform and reduce in diameter. As the diameter decreases, the seal between valve capsule 111 and balloon collar 114 is broken. The valve capsule is separated from the shell, and fluid contained inside the balloon freely flows through the opening 116 (FIG. 10b) that is created by the separation of the two portions.

Through the normal movements and contraction of the stomach walls, the balloon drains of the saline contained inside and shrinks down to a size that is passable through the human body. The combined microelectronics control and power supply and heating element(s) are safely contained within the valve capsule such that they do not present any danger to the patient.

Having received the confirmation signal, the patient may now leave the doctor's office and return home. The patient tracks the passage of the intragastric balloon and informs the doctor when it has passed.