GB2570906A

GB2570906A - Methods and systems for treating chronic or acute constipation

Info

Publication number: GB2570906A
Application number: GB1802101.4A
Authority: GB
Inventors: Morliere Camille; Bentsur Lior; Lampert Shalom
Original assignee: Vibrant Ltd
Current assignee: Vibrant Ltd
Priority date: 2018-02-08
Filing date: 2018-02-08
Publication date: 2019-08-14
Also published as: GB201802101D0

Abstract

The treatment of constipation using a vibrating ingestible capsule 130 which vibrates in the presence of a patient to be treated prior to ingestion of the capsule by the patient. A separate control unit 100 has a processor 104 to provide a signal to the capsule via a transmitter 110 to trigger demonstrative vibration of the capsule. The capsule itself contains a vibration motor 135 and associated controller 136 with a receiver or transceiver 138, a battery or capacitor 140, and preferably a timer 134. The control unit may be used to program the capsule with a vibration protocol via a short-range wireless method. A patient may input to the control unit a desired frequency, intensity and duration of vibration and a desired delay time prior to the initiation of vibration. The time delay is preferably between one and eight hours. The control unit may have a display showing instructions for the patient.

Description

METHODS AND SYSTEMS FOR TREATING CHRONIC OR ACUTE CONSTIPATION

FIELD OF THE INVENTION

The present invention relates in general to medical devices, particularly to methods and systems for treating disorders of the gastrointestinal tract, such as chronic or acute constipation.

SUMMARY OF THE INVENTION

In accordance with embodiments of the present invention, there is provided a method for treating a human patient suffering from chronic or acute constipation using a vibrating ingestible capsule, the method including:

providing the vibrating ingestible capsule to the patient;

triggering demonstrative vibrations of the vibrating ingestible capsule, in the presence of the patient, such that the patient observes or feels the demonstrative vibrations; and subsequently, ingesting the vibrating ingestible capsule by the patient.

In some embodiments, the method further includes pre-programming the vibrating ingestible capsule with at least one pre-defined vibration protocol prior to the triggering.

In some embodiments, the method further includes providing, using a control unit functionally associated with the vibrating ingestible capsule, information or an instruction regarding a vibration protocol to be used.

In some embodiments, the information regarding the vibration protocol includes an indication or selection of a specific vibration protocol pre-programmed into the vibrating ingestible capsule.

In some embodiments, the control unit generates the vibration protocol and provides the vibration protocol to the vibrating ingestible capsule as the information.

In some embodiments, the control unit receives, prior to generating the vibration protocol, input relating to at least one desired parameter of treatment with the vibrating ingestible capsule, and generates the vibration protocol based on the received input. In some such embodiments, the at least one desired parameter includes at least one of a desired vibration intensity, a desired vibration frequency, a desired length of vibration, and a desired delay time prior to initiating vibration.

In some embodiments, the input is received from the patient. In some embodiments, the input is received from at least one of a medical practitioner treating the patient, and a medical facility at which the patient is treated.

In some embodiments, the control unit provides the vibration protocol by remotely transmitting the vibration protocol to the vibrating ingestible capsule. In some such embodiments, the control unit provides the vibration protocol by transmitting to the vibrating ingestible capsule a list of vibration parameters for effecting the vibration protocol. In some such embodiments, the control unit provides the vibration protocol by transmitting to the vibrating ingestible capsule executable code for effecting the vibration protocol.

In some embodiments, the triggering includes providing an activation signal to the vibrating ingestible capsule, the activating signal activating the vibrating ingestible capsule to carry out the vibration protocol following the demonstrative vibrations.

In some embodiments, the activating includes remotely transmitting the activation signal, from the control unit to the vibrating ingestible capsule, using a short range wireless communication method.

In some embodiments, activating the vibrating ingestible capsule includes activating a timer of the vibrating ingestible capsule to immediately begin effecting the vibration protocol.

In some embodiments the method further includes, prior to the patient ingesting the vibrating ingestible capsule, providing to the patient reinforcing information about treatment with the vibrating ingestible capsule.

In some embodiments the method further includes engaging the patient in at least one psychosomatic neutralizing activity relating to the vibrating ingestible capsule.

In some embodiments the method further includes, following the patient ingesting the vibrating ingestible capsule, the vibrating ingestible capsule vibrating in the gastrointestinal tract of the patient.

In some embodiments the vibrating ingestible capsule is a placebo capsule and the method further includes, following the patient ingesting the vibrating ingestible capsule, the vibrating ingestible capsule not vibrating in the gastrointestinal tract of the patient.

In accordance with embodiments of the present invention, there is further provided a method for treating a patient suffering from chronic or acute constipation using a vibrating ingestible capsule, the method including:

engaging the patient in at least one psychosomatic neutralizing activity relating to the vibrating ingestible capsule; and subsequently, ingesting the capsule by the patient.

In some embodiments, engaging the patient in at least one psychosomatic neutralizing activity includes providing to the patient reinforcing information about treatment with the vibrating ingestible capsule. In some such embodiments, providing reinforcing information includes providing the reinforcing information via at least one media channel selected from a group of: written media, audible media, and video.

In some embodiments, the vibrating ingestible capsule is functionally associated with a control unit, and engaging the patient in at least one psychosomatic neutralizing activity includes receiving from the patient, at the control unit, user input relating to at least one desired parameter of treatment with the vibrating ingestible capsule.

In some embodiments the method further includes, at the control unit, receiving input relating to the treatment with the vibrating ingestible capsule from at least one of a medical practitioner treating the patient and a medical facility at which the patient is treated.

In some embodiments, the at least one desired parameter includes at least one of a desired vibration intensity, a desired vibration frequency, a desired length of vibration, and a desired delay time prior to initiating vibration.

In some embodiments, engaging the patient in at least one psychosomatic neutralizing activity includes allowing the patient to observe or feel vibration of the vibrating ingestible capsule.

In accordance with embodiments of the present invention, there is additionally provided a system for treating a patient suffering from chronic or acute constipation, the system including:

a vibrating ingestible capsule, including:

a housing;

a vibration motor disposed within the housing and adapted to effect vibration of the housing;

a controller configured to control vibration of the vibration motor; and a receiver, functionally associated with the processor; and a control unit, functionally associated with the vibrating ingestible capsule and including a processor adapted to provide at least one signal to the vibrating ingestible capsule via a transmitter;

wherein the processor of the control unit is adapted to provide to the vibrating ingestible capsule a signal triggering demonstrative vibration of the vibrating ingestible capsule.

In some embodiments, the control unit further includes a user input module functionally associated with the processor, adapted to receive input regarding at least one desired parameter of treatment with the vibrating ingestible capsule.

In some embodiments, the at least one desired parameter includes at least one vibration frequency, vibration intensity, length of vibration, and delay time between ingestion of the capsule and initiation of vibration.

In some embodiments, the signal triggering vibration includes an activation signal activating the controller of the vibrating ingestible capsule to effect a vibration protocol.

In some embodiments, vibration of the vibrating ingestible capsule in accordance with the vibration protocol begin at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, at least 5 hours, at least 6 hours, at least 7 hours or at least 8 hours after the demonstrative vibrations.

In some embodiments, the vibration protocol is pre-programmed into the controller of the vibrating ingestible capsule.

In some embodiments, the processor of the control unit is adapted to program the vibrating ingestible capsule with the vibration protocol.

In some embodiments, the processor of the control unit is adapted to program the vibrating ingestible capsule by remotely transmitting to the vibrating ingestible capsule, via the transmitter, information or an instruction relating to the vibration protocol. In some embodiments, the information relating to the vibration protocol includes a list of vibration parameters for effecting the vibration protocol. In some embodiments, the information relating to the vibration protocol includes executable code for effecting the vibration protocol.

In some embodiments, the processor of the control unit is adapted to generate the vibration protocol. In some embodiments, the processor is adapted to generate the vibration protocol based on input provided from the patient. In some embodiments, the processor is adapted to generate the vibration protocol based on input provided from a medical practitioner treating the patient or a medical facility at which the patient is treated.

In some embodiments, the vibrating ingestible capsule includes a timer and the activation signal is adapted to activate the timer to immediately begin effecting the vibration protocol.

In some embodiments, the control unit further includes a display, functionally associated with the processor and adapted to exhibit information to the patient, the processor is further adapted to provide data to be displayed on the display, and the processor is adapted to exhibit, on the display, instructions for the patient to at least one of hold and view the vibrating ingestible capsule, and to provide the signal triggering demonstrative vibration of the vibrating ingestible capsule within five minutes of finishing the instructions.

BRIEF DESCRIPTION OF THE FIGURES

The foregoing discussion will be understood more readily from the following detailed description of the invention, when taken in conjunction with the accompanying Figures (1-2), in which:

Figures 1 is a schematic block diagram of a system for treatment of a disorder in the gastrointestinal tract of a subject according to an embodiment of the present invention; and

Figure 2 is a schematic flowchart of a method for treatment of a disorder in the gastrointestinal tract of a subject according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The principles of the inventive system and method for treatment of a disorder in the gastrointestinal tract of a subject, and specifically for treatment of chronic constipation, may be better understood with reference to the drawings and the accompanying description.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

It has long been known to medical personnel, and particularly to gastrointestinal specialists, that psychosomatics play a significant part in some disorders of the gastrointestinal tract, such as chronic constipation. In many cases, patients suffering from chronic constipation have tried multiple treatment types, often having significant side effects, and which often afford little and/or diminishing relief.

It is further known that various medications and treatments currently available on the market have relatively low success rates, and relatively high incidence of side effects. For example, “Best Response Distribution of 12-Week Treatment with Prucalopride (RESOLOR) in patients with Chronic Constipation: Combined Results of Three Randomised, Double-Blind, Placebo-Controlled Phase III Trials” (Gut 2011 60: A159-A160) to Stanghellini et al, shows a success rate of approximately 23%, accompanied by a 15% side effect rate. In other words, 23% of the patients participating in the study and treated with Prucalopride showed an increased rate to spontaneous bowel movements during the treatment period, but 15% of the patients suffered from side effects, such as diarrhea.

Additionally, many currently available treatments, even when successfully treating the patient and providing an increase in the frequency of spontaneous bowel movements, tend to lose efficacy as the treatment continues, requiring increased dosages or transitioning to a new type of treatment, and often causing the patient pain or discomfort. Furthermore, such treatments typically treat the symptoms causing constipation and not the cause of constipation, and thus provide no relief to the patient once the treatment is stopped.

Another known characteristic of existing medications for treatment of constipation, is a placebo effect rate in the range of 3% to approximately 40%. For example, “Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trial of Eubiprostone, a Eocally-Acting Type-2 Chloride Channel Activator, in Patients With Chronic Constipation” (Am J Gastroenterol. (2008) 103, 170-177) to Johanson et al describes a minimal placebo effect rate of 3.46%, and a maximal placebo effect rate of 36.9%. “Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis” (UEG J 2013: 1(1) 48-59) to Tack et al shows a minimal placebo effect rate of 11%, and a maximal placebo effect rate of 38.4%.

Due to all of the limitations above, many chronic constipation patients have a negative, or skeptical, attitude towards treatments offered to them by their medical practitioners.

Without wishing to be bound by theory, it is considered that in some cases, the negative or skeptical attitude of the patients, may psychosomatically exacerbate their symptoms, or inhibit the treatment from attaining full efficacy, for example due to stress experienced by the patient when taking the treatment.

The inventors have discovered that when patients suffering from chronic constipation are treated with a vibrating capsule as described hereinbelow, the treatment success rate may be around 50% or even higher. Furthermore, the inventors have discovered that when the patients saw the capsule vibrate prior to ingesting the capsule, the placebo effect rate was higher than 45%.

Without wishing to be bound by theory, the inventors believe that the high efficacy of treatment with a vibrating capsule as described hereinbelow is at least in part due to the fact that the capsule induces contractions within the gastrointestinal tract, and thus “reminds” the body how to generate spontaneous bowel movements, or otherwise induces the body to generate such spontaneous bowel movements. The inventors further believe that treatment with a vibrating capsule as described herein may “reset” the internal pacemaker controlling contractions of the large intestine, allowing for more naturally-occurring contractions of the large intestine, and generation of more spontaneous bowel movements, even when the treatment is terminated.

Additionally, without wishing to be bound by theory, the inventors surmise that due to the high involvement of psychosomatic effects in chronic constipation symptoms, symptoms frequently can be alleviated, or at least improved, by removing the psychological negativity at the base of the psychosomatic symptoms. For example, the patient may receive treatment, be it an active treatment or a placebo, following an event which gives the patient a positive attitude towards the treatment, or at least neutralizes the negativity towards the treatment, which is at the base of psychosomatically generated symptoms.

The inventors have found that, for treatment with a vibrating capsule as described hereinbelow, such a positive attitude can be generated by the medical practitioner providing to the user information regarding the way that the treatment works, the high success rates, the lack of side effects, and explaining that there is a chance that the efficacy of the treatment would increase with time, and possibly even continue once the treatment is stopped.

Similarly, a positive attitude may be generated by the capsule vibrating prior to being swallowed by the patient, such that the patient sees the capsule vibrating, or even holds the capsule in his hand and feels the capsule vibrate, such that the patient knows for certain that the capsule can vibrate. A positive attitude may further be generated by the patient being able to, to some degree, control capsule functionality, for example by being able to personalize the vibration intensity of the capsule.

For the purposes of this application, the term “subject” relates to a human or mammal.

For the purposes of this application, the term “patient” relates to a human or mammal suffering from chronic constipation.

For the purposes of this application, the term “chronic constipation” relates to a spontaneous bowel movement frequency (SBM) of at most 3 SBMs per week,

For the purposes of this application, the term “acute constipation” relates to a subject suffering from a specific event of constipation, without suffering from chronic constipation.

For the purposes of this application, the term “placebo effect rate” relates to the percentage of subjects or patients in a study or medical trial, receiving a placebo treatment, who showed a positive response to the placebo as they were expected to show had they received the actual treatment. Such a positive response may be expressed as an increase, of at least a threshold value, in the number of SBMs per unit time.

For the purposes of this application, the term “attitude neutralizing activity” relates to an activity that at least removes the negative attitude, concern, stress, or worry associated with a treatment for chronic constipation, with possible side effects or placebo effect of such treatment, and possibly generates a positive attitude or expectation toward such treatment.

For the purposes of this application, the term “vibrating ingestible capsule” relates to an ingestible capsule adapted to vibrate, for a cumulative duration of at least one minute, in accordance with internal vibration parameters of the capsule.

For the purposes of this application, the term “short range wireless communication method” relates to any wireless communication method or protocol in which signals are communicated up to a maximum range of at most 1 kilometer or less, at most 500 meters, at most 300 meters, at most 200 meters, at most 100 meters, at most 50 meters, or at most 10 meters such as, for example, Bluetooth communication, Wi-Fi communication, RFID signal communication, and the like.

For the purposes of this application, the term “intermittent vibration motor” refers to a vibration motor which vibrates and is operative at certain times, and does not vibrate at other times, the activation times being selected by a processor or other control unit controlling the vibration motor.

For the purposes of this application, the terms “vibrating capsule”, “vibrating ingestible capsule”, and the like relate to capsule which includes a vibration motor and is capable of producing vibrations.

Referring now to the drawings, Figure 1 is a schematic block diagram of a system for treatment of a disorder in the gastrointestinal tract of a person according to an embodiment of the present invention.

As seen in Figure 1, a control unit 100 includes a user input module 102, a processor 104, a programming module 106, and a verification and activation module 108. In some embodiments, the control unit 100 further includes a transceiver 110. The control unit further includes at least one power source 112 providing power to user input module 102, processor 104, programming module 106, verification and activation module 108, and/or transceiver 110.

It will be appreciated that control unit 100 may be any suitable control unit, including a suitably programmed computing device such as a smartphone, a tablet computer, laptop computer, desktop computer, and the like, or may be a dedicated control unit, e.g. forming part of another medical device.

Control unit 100 is configured to control, program, verify, and/or activate a programmable vibrating ingestible capsule 130. Programmable vibrating ingestible capsule 130 includes a timer 134; a motor, such as an intermittent vibration motor 135; a controller 136, functionally associated with timer 134 and with vibration motor 135; a receiver or transceiver 138 functionally associated with the controller 136; and at least one power source 140 providing power to timer 134, vibration motor 135, controller 136, and/or receiver/transceiver 138.

Power source 140 may be any suitable power source, such as, for example, one or more alkaline or silver oxide batteries, primary batteries, rechargeable batteries, capacitors and/or super capacitors. Additional details and functionality of programmable vibrating ingestible capsule 130 are described hereinbelow.

The user input module 102 is configured to receive input from a user, be it input relating to the treatment, such as a desired vibration frequency, or input to facilitate tracking the effects of the treatment, such as information regarding the occurrence of a spontaneous bowel movement (in order to facilitate tracking of the frequency of spontaneous bowel movements).

The user input module 102 may be any suitable input module, and may include, for example, a keyboard, a pointing device such as a mouse, a touchscreen, or a touchpad configured to receive input entered directly by the patient, a caretaker of the patient, medical personnel treating the patient, or any other input provider.

In some embodiments, the control unit 100 further includes a display, functionally associated with the processor 104 and/or with the user input device, which display is adapted to exhibit to the user one or more questions to be answered, the answers provided as input to the user input module 102. For example, the display may exhibit a scale from 1-10, and ask the patient to indicate the desired vibration intensity by indicating a specific level on the scale, which indication may be provided to user input module 102.

As another example, the user input module may be operable by a medical practitioner or a caregiver of the patient.

Processor 104 is configured to receive the user input from user input module 102, and to use the received input to track the bowel movement frequency of the user, and/or to determine one or more characteristics of a desired treatment to be provided by a specific capsule, such as the vibration frequency, the vibration intensity, and the like. Based on the provided input and on pre-programmed information available to the processor 104, the processor may generate a vibration treatment protocol for the patient, the protocol including vibration parameters to be programmed into programmable vibrating ingestible capsule 130.

It will be appreciated that the generated vibration protocol may also be a placebo protocol, which, when programmed into capsule 130 does not cause the capsule 130 to vibrate following ingestion of the capsule, or would include minimal vibration following ingestion. In some embodiments of the placebo protocol, the capsule 130 may vibrate prior to ingestion thereof so that the patient sees, or feels, the capsule vibrate.

The programming module 106 is configured to receive the vibration treatment protocol from the processor 104, and to program controller 136 of programmable vibrating ingestible capsule 130 to implement the vibration treatment protocol upon activation thereof. In some embodiments, the programming module 106 includes a transmitter, or is functionally associated with a transmitter, such as transmitter/transceiver 110, for transmission of the vibration treatment protocol to the receiver/transceiver 138 of capsule 130.

In some embodiments, the programming module 106 transmits the protocol to the capsule 130 as a sequence of parameter signals, such as digits, indicating time frames from activation and vibration parameters to be used at those time frames. In some embodiments, the programming module 106 transmits the protocol to the capsule 130 as executable code to be used by the controller 136 to automatically activate vibration motor 135 in accordance with the protocol.

In some embodiments, controller 136 of capsule 130 is pre-programmed with a pre-defined vibration treatment protocol. In some such embodiments, the processor 104 need not generate a vibration treatment protocol, and programming module 106 need not program capsule 130, and may, in some embodiments, even be obviated.

In some embodiments, controller 136 of capsule 130 is pre-programmed with multiple pre-defined vibration treatment protocols. In some such embodiments, the processor 104 or programming module 106 may instruct the controller 136 of capsule 130 which of the vibration treatment protocols should be used.

In some embodiments, controller 136 of capsule 130 is pre-programmed with one or more pre-defined vibration treatment protocols each including one or more variables. In some such embodiments, processor 104 generates suitable values to be used for the variables, and programming module 106 programs the controller 136 with the selected values.

The activation module 108 is configured to activate the programmable vibrating ingestible capsule 130 for operation. In some embodiments, activation of the capsule 130 includes immediate activation of the timer 134 to start counting time (i.e., a countdown) until activation of the vibration motor. Such embodiments assume that the capsule 130 is activated shortly before the patient ingests the capsule.

In some embodiments, the activation module 108 includes a transmitter, or is functionally associated with a transmitter or transceiver such as transmitter/transceiver 110, and activates the capsule 130 by providing an activation signal thereto.

In some embodiments, the activation module 108 also includes a verification module, configured to verify that the capsule 130 received the vibration treatment protocol and is capable of effecting the protocol without error. In some embodiments, the verification module includes, or is functionally associated with a receiver, receiving from the capsule 130 a verification signal indicating that the capsule has received the protocol.

In some embodiments, the verifications signal comprises the capsule 130 vibrating in accordance with a specific vibration pattern indicative of verification thereof, the verification module includes a vibration sensor, sensing the vibration of the capsule 130.

In some embodiments, the vibration of the capsule 130 in accordance with a specific vibration pattern, is visible to the patient prior to ingestion of the capsule. In some embodiments, the display of the control unit 100 instructs the user to hold the capsule prior to providing the activation signal to the capsule 130, such that when the capsule 130 vibrates, the user feels the vibration in his hand.

In some embodiments, the input module 102 of control unit 100 is configured to continue receiving input from the patient regarding excretions thereby or a frequency of excretions during and after treatment with the capsule 130 based on the vibration treatment protocol generated by processor 104. In such embodiments, processor 104 is further configured to use such additional input to identify a change in a frequency of excretions for the patient being treated, and/or to update the vibration treatment protocol for the patient based on such a change.

Reference is now made to Figure 2, which is a schematic flowchart of a method for treatment of a disorder in the gastrointestinal tract of a subject according to the present invention. It will be appreciated that, for clarity, the method of Figure 2 is described with respect to the system of Figure 1, though it may be implemented using any suitable system, and implementation is not limited to the specific system shown in Figure 1.

As seen at step 200, the patient may receive reinforcing information about the treatment, for example from medical personnel such as a nurse or a doctor, or independently by reading about the treatment or by watching a video clip or other media presentation about the treatment. Such reinforcing information may include:

an indication of the clinically established success rate of treatment, shown by the inventors to be approximately 50% as compared to a success rate in the range of 20%-25% obtained by the currently available pharmaceutical treatments;

an indication of the lack of side effects during treatment with a vibrating ingestible capsule as described hereinabove;

an explanation of the method by which the vibrating ingestible capsule provides treatment, explaining that the capsule is thought to generate naturally-occurring contractions within the gastrointestinal tract, and thus “reminds” the body how to function naturally, or otherwise induces the body to generate such spontaneous bowel movements; an explanation as to the expected increase in efficacy of the treatment as the treatment continues, as discussed hereinabove; and/or an indication that in some cases the treatment may cause the pacemaker controlling contractions within the gastrointestinal tract and/or large intestine to “reset”, such that the relief provided by the treatment may continue even after treatment is terminated, as discussed hereinabove.

It will be appreciated that the patient receiving such reinforcing information about the treatment may significantly reduce the patient’s stress and/or negativity regarding ingesting the capsule and being treated thereby, and may even cause the patient to be optimistic regarding the treatment, thus neutralizing possible psychosomatically-induced symptoms or other psychosomatic effects that prevent or disrupt efficacious treatment.

As seen at step 202, the patient may provide input to processor 104 of control unit 100 regarding desired vibration parameters during treatment, for example via user input module 102. In some embodiments, parameters that may be provided by the user include vibration intensity, vibration frequency, length of vibration and/or delay time until vibration begins, within a predetermined range that would not disrupt the functionality of the capsule. For example, the display of control unit 100 may exhibit to the user a question, such as “what should the vibration intensity be for your capsule”, and the user may be able to provide the input by selecting a desired vibration intensity, either between several discrete options, such as “low”, “medium” and “high”, or along a continuum, such as by setting a pointer to any point between the numbers 1 and 10, where 1 represents low intensity and 10 represents high intensity.

It will be appreciated that the patient being able to provide such input may allow the patient a measure of control of the treatment, which may relieve stresses experienced by the user when thinking about the treatment, and thus may neutralize psychosomatic effects or symptoms that may occur due to such stresses. For example, if the patient is worried about feeling uncomfortable by the vibration, they may set the vibration intensity to a lower value thereby alleviating such concern.

It will be appreciated that a similar neutralizing effect may be achieved if another person, such as a caretaker or medical practitioner, provides the input to control unit 100 via the input module 102, provided that the input being provided is selected or controlled by the patient. For example, the patient’s caretaker or medical practitioner may ask the patient what vibration intensity they desire, and then input the vibration intensity desired by the patient.

In some embodiments, processor 104 of control unit 100 may obtain additional information regarding the patient or the capsule. For example, the medical practitioner may provide information regarding symptoms experienced by the patient, for example via user input module 102. As another example, the processor 104 may obtain additional information regarding the patient or the desired treatment from a remote location, such as a remotely located medical facility or a suitable database, for example via transceiver 110.

At step 204, a vibration treatment protocol is generated for the patient at the control unit 100, based on the input received from the user via user input module 102 and on additional input obtained by processor 104, for example from a medical practitioner or from a database. The vibration treatment protocol is programmable into a programmable vibrating ingestible capsule, such as capsule 130.

In some embodiments, the generated protocol specifies times at which the capsule should vibrate, and parameters for such vibration.

In some embodiments, the input obtained from a medical practitioner or medical facility indicates that the capsule should function as a placebo capsule. In some such embodiments, the treatment protocol specifies that the capsule should not vibrate following ingestion thereof.

Turning to step 206, it is seen that a programmable vibrating ingestible capsule is programmed to implement the vibration treatment protocol generated at step 204. In some embodiments, programming includes wirelessly transmitting the vibration treatment protocol from the programming module 106 of the control unit 100 to a transceiver or receiver 138 of the programmable vibrating ingestible capsule via transceiver 110 of the control unit, substantially as described hereinabove.

It will be appreciated that, in some embodiments, one or more vibration treatment protocols may be pre-programmed into a vibrating ingestible capsule, such as capsule 130. In some such embodiments, step 204 may be obviated. In embodiments in which a single vibration treatment protocol is pre-programmed into the capsule, step 206 may also be obviated. In embodiments in which the capsule is pre-programmed with multiple vibration treatment protocols, programming the capsule at step 206 includes indicating to the capsule which of the pre-programmed vibration treatment protocols should be used.

At step 208, the programmed programmable vibrating ingestible capsule is verified and activated to carry out the vibration treatment protocol. In some embodiments, verifying and activating the capsule includes transmitting a wireless activation signal from the control unit 100 to the capsule 130, for example via transceivers 110 and 138, and observing a response of the capsule 130 which is indicative of the capsule receiving the signal and being properly programmed and ready for operation. In some embodiments, the response of the capsule includes the capsule vibrating for a predetermined duration or in accordance with a specific pattern which is indicative of the capsule receiving the activation signal and being ready for operation.

It is a particular feature of the teachings herein that if the capsule is verified and activated, as described hereinabove, in the presence of the patient, the patient can see, and if he is holding the capsule in his hand can even feel, that the capsule actually works, or vibrates.

It will be appreciated that the patient being able to observe or feel vibration of the capsule prior to ingesting the capsule, and to see that the capsule in fact functions as it is supposed to, may relieve concerns regarding the efficacy of the treatment and or about the treatment not working as promised, and thus may neutralize psychosomatic effects or symptoms. It will be appreciated that such neutralizing of psychosomatic effects occur even in a study setting, when the patient does not know if he is in the study or placebo group, and regardless of whether or not the capsule actually vibrates in the patient’s body or is a placebo. Without wishing to be bound by theory, it is surmised that the patient observing the vibration of the capsule leads the patient to subconsciously believe that the capsule will also vibrate within their body, and thus removes psychosomatic effects and enables an improvement of the patient’s symptoms, even if the capsule is in fact a placebo capsule.

At step 210 the programmed, verified, and activated capsule is provided to the subject for ingestion, after the user has experienced at least one psychosomatic neutralizing activity as described with respect to steps 200, 202, and 208. It will be appreciated that step 210 is included in embodiments in which steps 200-208 occur in a medical facility, factory, or other such location. However, in some embodiments, the capsule may be provided to the patient for use in the comfort of their own home, prior to steps 200-208, or in between two of these steps. In such embodiments, step 210 may be obviated. Subsequently, at step 212, operation of the vibration treatment protocol by components of the capsule begins following ingestion thereof by the subject.

It will be appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification, including GB1522740.8 and PCT/IB2013/000203, are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

1. A method for treating a human patient suffering from chronic or acute constipation using a vibrating ingestible capsule, the method comprising:

providing the vibrating ingestible capsule to the patient;

triggering demonstrative vibrations of the vibrating ingestible capsule, in the presence of the patient, such that the patient observes or feels said demonstrative vibrations; and subsequently, ingesting the vibrating ingestible capsule by the patient.

2. The method of claim 1, further comprising pre-programming the vibrating ingestible capsule with at least one pre-defined vibration protocol prior to said triggering.

3. The method of claim 1, further comprising providing, using a control unit functionally associated with said vibrating ingestible capsule, information or an instruction regarding a vibration protocol to be used.

4. The method of claim 3, wherein said information regarding said vibration protocol includes an indication or selection of a specific vibration protocol preprogrammed into said vibrating ingestible capsule.

5. The method of claim 3, wherein said control unit generates said vibration protocol and provides said vibration protocol to said vibrating ingestible capsule as said information.

6. The method of claim 5, wherein said control unit receives, prior to generating said vibration protocol, input relating to at least one desired parameter of treatment with said vibrating ingestible capsule, and generates said vibration protocol based on said received input.

7. The method of claim 6, wherein said at least one desired parameter comprises at least one of a desired vibration intensity, a desired vibration frequency, a desired length of vibration, and a desired delay time prior to initiating vibration.

The method of claim 6 or claim 7, wherein said input is received from said patient.

9. The method of claim 6 or claim 7, wherein said input is received from at least one of a medical practitioner treating said patient, and a medical facility at which the patient is treated.

10. The method of any one of claims 5 to 9, wherein said control unit provides said vibration protocol by remotely transmitting said vibration protocol to said vibrating ingestible capsule.

11. The method of claim 10, wherein said control unit provides said vibration protocol by transmitting to said vibrating ingestible capsule a list of vibration parameters for effecting said vibration protocol.

12. The method of claim 10, wherein said control unit provides said vibration protocol by transmitting to said vibrating ingestible capsule executable code for effecting said vibration protocol.

13. The method of any one of claims 2 to 12, wherein said triggering includes providing an activation signal to said vibrating ingestible capsule, said activating signal activating said vibrating ingestible capsule to carry out said vibration protocol following said demonstrative vibrations.

14. The method of any one of claims 8 to 13, wherein said activating comprises remotely transmitting said activation signal, from said control unit to said vibrating ingestible capsule, using a short range wireless communication method.

15. The method of any one of claims 8 to 14, wherein said activating said vibrating ingestible capsule includes activating a timer of said vibrating ingestible capsule to immediately begin effecting said vibration protocol.

16. The method of any one of claims 1 to 15, further comprising, prior to said patient ingesting said vibrating ingestible capsule, providing to the patient reinforcing information about treatment with said vibrating ingestible capsule.

17. The method of any one of claims 1 to 16, further comprising engaging the patient in at least one psychosomatic neutralizing activity relating to said vibrating ingestible capsule.

18. The method of any one of claims 1 to 17, further comprising, following said patient ingesting said vibrating ingestible capsule, said vibrating ingestible capsule vibrating in the gastrointestinal tract of said patient.

19. The method of any one of claims 1 to 17, wherein said vibrating ingestible capsule is a placebo capsule, the method further comprising, following said patient ingesting said vibrating ingestible capsule, said vibrating ingestible capsule not vibrating in the gastrointestinal tract of said patient.

20. A method for treating a patient suffering from chronic or acute constipation using a vibrating ingestible capsule, the method comprising:

engaging the patient in at least one psychosomatic neutralizing activity relating to said vibrating ingestible capsule; and subsequently, ingesting the capsule by the patient.

21. The method of claim 20, wherein said engaging said patient in at least one psychosomatic neutralizing activity comprises providing to the patient reinforcing information about treatment with said vibrating ingestible capsule.

22. The method of claim 21, wherein said providing reinforcing information includes providing said reinforcing information via at least one media channel selected from a group of: written media, audible media, and video.

23. The method of any one of claims 20 to 22, wherein said vibrating ingestible capsule is functionally associated with a control unit, and wherein said engaging said patient in at least one psychosomatic neutralizing activity comprises receiving from said patient, at said control unit, user input relating to at least one desired parameter of treatment with said vibrating ingestible capsule.

24. The method of claim 23, further comprising, at said control unit, receiving input relating to said treatment with said vibrating ingestible capsule from at least one of a medical practitioner treating said patient and a medical facility at which the patient is treated.

25. The method of claim 23 or claim 24, wherein said at least one desired parameter comprises at least one of a desired vibration intensity, a desired vibration frequency, a desired length of vibration, and a desired delay time prior to initiating vibration.

26. The method of any one of claims 21 to 25, wherein said engaging said patient in at least one psychosomatic neutralizing activity comprises allowing said patient to observe or feel vibration of said vibrating ingestible capsule.

27. A system for treating a patient suffering from chronic or acute constipation, the system comprising:

a vibrating ingestible capsule, including:

a housing;

a vibration motor disposed within said housing and adapted to effect vibration of said housing;

a controller configured to control vibration of said vibration motor; and a receiver, functionally associated with said processor; and a control unit, functionally associated with said vibrating ingestible capsule and including a processor adapted to provide at least one signal to said vibrating ingestible capsule via a transmitter;

wherein said processor of said control unit is adapted to provide to said vibrating ingestible capsule a signal triggering demonstrative vibration of said vibrating ingestible capsule.

28. The system of claim 27, said control unit further comprising a user input module functionally associated with said processor, adapted to receive input regarding at least one desired parameter of treatment with said vibrating ingestible capsule.

29. The system of claim 28, wherein said at least one desired parameter comprises at least one vibration frequency, vibration intensity, length of vibration, and delay time between ingestion of said capsule and initiation of vibration.

30. The system of any one of claims 27 to 29, wherein said signal triggering vibration comprises an activation signal activating said controller of said vibrating ingestible capsule to effect a vibration protocol.

31. The system of claim 30, wherein vibration of said vibrating ingestible capsule in accordance with said vibration protocol begin at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, at least 5 hours, at least 6 hours, at least 7 hours or at least 8 hours after said demonstrative vibrations.

32. The system of claim 30 or claim 31, wherein said vibration protocol is preprogrammed into said controller of said vibrating ingestible capsule.

33. The system of claim 30 or claim 31, wherein said processor of said control unit is adapted to program said vibrating ingestible capsule with said vibration protocol.

34. The system of claim 33, wherein said processor of said control unit is adapted to program said vibrating ingestible capsule by remotely transmitting to said vibrating ingestible capsule, via said transmitter, information or an instruction relating to said vibration protocol.

35. The system of claim 34, wherein said information relating to said vibration protocol includes a list of vibration parameters for effecting said vibration protocol.

36. The system of claim 34, wherein said information relating to said vibration protocol includes executable code for effecting said vibration protocol.

37. The system of any one of claims 33 to 36, wherein said processor of said control unit is adapted to generate said vibration protocol.

38. The system of claim 37, wherein said processor is adapted to generate said vibration protocol based on input provided from said patient.

39. The system of claim 37 or claim 38, wherein said processor is adapted to generate said vibration protocol based on input provided from a medical practitioner treating said patient or a medical facility at which said patient is treated.

40. The system of any one of claims 30 to 39, said vibrating ingestible capsule including a timer and wherein said activation signal is adapted to activate said timer to immediately begin effecting said vibration protocol.

41. The system of any one of claims 27 to 40, wherein said control unit further comprises a display, functionally associated with said processor and adapted to exhibit information to said patient, wherein said processor is further adapted to provide data to be displayed on said display, and wherein said processor is adapted to exhibit, on said display, instructions for said patient to at least one of hold and view said vibrating ingestible capsule, and to provide said signal triggering demonstrative vibration of said vibrating ingestible capsule within five minutes of finishing said instructions.