Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/372—Arrangements in connection with the implantation of stimulators
  • A61N1/37211—Means for communicating with stimulators
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
  • A61B5/0031—Implanted circuitry
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
  • A61B5/036—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems

Definitions

• the invention relates generally to the field of bio-feedback methods and systems, and specifically to methods and systems for treating irritable bowel syndrome using bio-feedback data.
• IBS Irritable Bowel Syndrome
• Ultrichlora a disorder that interferes with the normal functions of the large intestine (colon/bowel). IBS causes stomach pain, bloating, and abnormal bowel movements. People with IBS often have chronic diarrhea, constipation, or both. Some patients have no abdominal pain in the morning, and get stomachaches in the afternoon. Others go for two weeks without pain, and then have a day of crippling pain. [0003] It is estimated that as many as one in five Americans has IBS, making it one of the most common disorders diagnosed by doctors. Generally, LBS is more common in women than in men and usually begins around age 20. [0004] IBS causes a great deal of discomfort and distress.
• IBS IBS symptoms
• bowel and colon are used interchangeably. Research suggests that people with IBS seem to have a bowel that is more sensitive and reactive than usual to a variety of things, including certain foods and stress. IBS symptoms result from the bowel not working properly. For example, the bowel can be spasmodic or can even stop temporarily. Spasms within the bowel are sudden strong muscle contractions that come and go.
• the epithelium appears to work properly but fast movement of the bowel's contents can overcome its absorptive capacity.
• the bowel responds strongly to stimuli, such as food or stress, that would not bother most people. It has been found that stress, emotions, and diet can strongly affect the bowel's functioning and play a significant role in the onset of the pain experienced by IBS sufferers.
• Bowel motility the contraction of the bowel muscles and the movement of its contents, is controlled by nerves and hormones and by electrical activity in the bowel muscle. If the muscles of the bowel do not contract in a coordinated way, or if they contract in an irregular way or with increased force (i.e. pressure), the contents within the bowel do not move smoothly, resulting in abdominal pain, cramps, constipation or diarrhea, and/or a sense of incomplete stool movement. [0008] No cure has been found for IBS.
• Litronex alosetron hydrochloride
• Zelnorm tegaserod maleate
• laxatives laxatives
• antidepressants are used to treat IBS, these medications are not effective in all people and do not entirely prevent the onset of LBS symptoms. Moreover, some of these medications have serious side effects, such as severe constipation or decreased blood flow to the bowel. Laxatives can be habit forming if
• Solid state manometry probes and water perfused manometry probes exist are designed to take pressure measurements within hollow organs. While these manometry apparatus exist, no one has ever used these probes in a way to solve the above need.
• Another object is to provide a system and method for treating IBS that informs a patient of an aggravated state in his/her bowel in sufficient time so that he/she can take remedial action.
• Yet another object is to provide a system and method for treating IBS that informs a patient of an aggravated state in his/her bowel so that he/she can realize that their discomfort is from IBS.
• Still another object is to provide a system and method for treating IBS that informs a patient of an aggravated state in his/her bowel so that he/she can identify the source of stress and/or dietary intake causing IBS symptoms.
• a further object is to provide a system and method for treating IBS that informs a patient of an aggravated state in his/her bowel so that he/she can recognize patterns in their LBS symptoms.
• Another object is to provide a system and method for treating IBS that informs a patient of an aggravated state in his/her bowel in sufficient time so that remedial action can be taken.
• a still further object is to provide a system and method for treating IBS that gives a patient confidence to partake in normal social activities.
• a method for treating IBS comprising: inserting a probe into a bowel of a patient having IBS, the probe adapted to measure pressure at one more locations within the bowel and obtain pressure data; transmitting the pressure data to a receiver having a processor; processing the pressure data with the processor to determine an aggravated state; and signaling the aggravated state to the patient.
• the method further comprises the step of instructing the patient to take measures to alleviate, reduce, or delay onset of the aggravated state.
• measures can include performing relaxation exercises, resting, meditating, massaging an abdomen of the patient, and relating the aggravated state to ingestion of certain foods.
• the method of the present invention is preferably performed by affixing either a solid state manometry probe or a water perfused manometry probe to a wall of the bowel.
• the probe can be affixed used any known method in the art, such as gluing, suturing, stapling, or using tacks, pins, elastic bands, or other attachments that at least partially capture or penetrate the wall of the bowel.
• the probe once affixed, preferably transmits the pressure data it obtains to the receiver via wireless means, such as a radio frequency transmitter. Alternatively, the pressure data obtained by the probe can be transmitted to the receiver via a wire within a catheter.
• the receiver can signal the patient of the presence of the aggravated state by creating an audio signal through a speaker, displaying an image on a display screen/area, illuminating a light source such as an LED, vibrating, or displaying the measured pressure data on the receiver.
• the invention is a system for treating IBS comprising: a pressure probe adapted to be inserted into a bowel of a patient having LBS, the pressure probe having means to measure pressure at one more locations within the bowel and obtain pressure data and means to transmit the pressure data; a receiver having means to receive the pressure data transmitted by the pressure robe; a processor programmed to process the pressure data to determine an aggravated state; and means to signal the aggravated state to the patient.
• the system preferably has means to instruct the patient to take measures to alleviate, reduce, or delay onset of the aggravated state.
• the means to instruct the patient can be an image on a display area of the receiver.
• the measure can include instructing the patient to perform relaxation exercises, rest, meditate, or avoid foods causing increased bowel pressure.
• the means to signal the patient of the aggravated state can be a speaker, an image display, a light source, a vibration source, or a pressure display. It is further preferable that the means to signal be located on the receiver.
• the pressure probe can be a solid state manometry probe or a water perfused manometry probe.
• the pressure probe be wireless and adapted to be fixed to a wall of the bowel. In this embodiment wireless technology is used and the means to transmit the pressure data can be a radio frequency transmitter and the means to receive the pressure data can be a radio frequency receiver. Alternatively, the means to transmit the pressure data can be a wire within a catheter.
• the invention is a method for treating IBS comprising: inserting a probe into a bowel of a patient having IBS, the probe adapted to measure pressure at one more locations within the bowel and obtain pressure data; inserting a colon pace-setter into the bowel, the colon pace-setter adapted to regulate muscle contractions of the bowel upon receipt of a regulation signal; transmitting the pressure data to a receiver having a processor; processing the pressure data with the processor to determine an aggravated state; upon determination of an aggravated state, generating the regulation signal with the processor; and transmitting the regulation signal to the colon pace-setter.
• the colon pace-setter and the probe can be contained within a single device.
• the regulation signal is preferably transmitted from the receiver to the colon-pace setter via wireless means.
• Figure 1 is a side view of a section of a colonoscope coupled to a delivery cable positioning a solid state manometry probe to the wall of a bowel according to the present invention.
• Figure 2 is a schematic of the solid state manometry probe of FIG. 1 communicating via radio frequency with a receiver according to the present invention.
• Figure 3 is a perspective view of the receiver shown in FIG. 2.
• Figure 4 is a schematic of the electronics within the receiver of FIG. 3.
• Figure 5 is a flowchart of an embodiment of a method of treating IBS according to the present invention. Modes for Carrying Out the Invention
• colonoscope 10 is coupled to delivery cable 11.
• Delivery cable 11 comprises niche 12 and colonoscope light 16.
• Tape 17 is used to connect colonoscope 10 to delivery cable 11 for insertion into the bowel cavity 15 of a patient 100 (Fig. 2) having IBS.
• Niche 12 is adapted to receive solid-state manometry probe 13.
• Niche 12 holds solid-state manometry probe 13 during the insertion of colonoscope 10 and delivery cable 11 into bowel cavity 15.
• Colonoscope light 16 provides illumination so that solid-state manometry probe 13 can be properly positioned on bowel/mucosoal wall 14 of bowel cavity 15.
• Solid state manometry probe 13 comprises aspiration orifice 18 and radio frequency transmitter 19.
• Colonoscope 10 and delivery cable 11 are fed into bowel cavity 15 until the position is reached where it is desirable to affix solid- state manometry probe 13 to bowel wall 14 for monitoring the bowel wall 14 and bowel cavity 15 for irregular or increased pressure fluctuations caused by muscle contractions related to IBS. Once the proper position is reached, colonoscope 10 and delivery cable 11 are manipulated so that solid-state manometry probe 13 contacts the bowel wall 14 of bowel cavity 15. Aspiration orifice 18 is then activated, pulling in a mucosoal portion 20 of the bowel wall 14 of bowel cavity 15.
• Solid-state manometry probe 13 is adapted to measure pressure within bowel cavity 15 and can detect changes in pressure during stimulation (i.e., muscle contraction).
• Solid-state manometry probe 13 preferably has several measurement ports spaced at defined intervals (not illustrated). Each measurement port comprises a miniaturized solid state transducer that can measure and detect changes in pressure.
• the coordination of contractile activity along wall 14 of bowel 15 can be measured as well as pressure in the bowel cavity 15.
• a water-perfused manometry probe can be used in replace of a solid-state manometry probe.
• Water-perfused manometry probes rely on an assembly of thin, water-perfused tubes with side holes spaced a various distances. These thin catheters are glued together forming a tube. To record pressure changes, the catheter is connected to a low compliance multi-channel perfusion system. The low compliance of both the perfusion system as well as the catheter is critical to minimize measurement artifacts as high compliance would blunt the amplitude of pressure change and significantly limit the rate at which such changes can be properly recorded.
• solid-state manometry probe 13 is properly placed in the bowel 15 of5IBS patient 100.
• Solid-state manometry probe 13 is in wireless communication with receiver 50 via RF signals 40.
• RF radio frequency
• Such communication technology is known in the art and is disclosed in United States Patent 6,285,897, which is incorporated herein by reference in its entirety.
• RF radio frequency
• Receiver 50 comprises an RF receiver 51 that is adapted to receive RF signals 40 from solid-state manometry probe 13.
• Receiver 50 comprises RF receiver 51, processor 52, display screen 53, LED 54, vibration source 55, speaker 56, and bus 57.
• RF receiver 51 receives RF signal 40 from solid-state manometry probe 13.
• RF signal 40 represents the pressure data collected from solid-state manometry probe 13.
• RF receiver 51 converts incoming RF signal 40 to an electrical signal and transmits this electrical signal (i.e., the pressure data) to processor 52.
• Processor 52 receives the pressure data measurements retrieved by solid-state manometry probe 13 and process/analyzes the pressure data to determine whether the data represents an aggravated state. This can be achieved by properly programming processor 52 in a variety of ways. For example, processor 52 can be programmed to receive pressure data from solid-state manometry probe 13 over a period of time when the bowel of patient 100 is functioning normally. Processor 52 will then recognize pressure measurements within a certain range of the normal measurements as being a non-aggravated state. Normalcy can be based upon the magnitude, frequency, spasmodic nature, or pattern of contraction pressures created in bowel 15. Alternatively, processor 52 can be pre-programmed to correlate specified pressure data parameter ranges as being non-aggravated. [0038] Upon processor 52 processing the pressure data and detecting an
• processor 52 generates and sends a warning signal to one or all of display screen 53, LED 54, speaker 56, or vibration source 55 via bus 57.
• the appropriate component 53, 54, 56, 55 will respond accordingly.
• LED 54 may be illuminated upon receiving the warning signal; speaker 56 may output a warning sound/tome, vibration source 55 may vibrate receiver 50, and/or display screen 53 may display an image, text, or pressure data relaying the aggravated state to the user.
• any combination of or single component 53, 54, 56, or 55 can be used to signal the aggravated state to the user.
• receiver 50 can be designed in any shape or form.
• receiver 50 can be designed to attach to be worn around the waist of a user or can be designed to be worn like a watch.
• receiver 50 comprises display screen 53, LED 54, and speaker 56.
• Processor 52 (Fig. 4) can be programmed to display a variety of images or text messages on display screen 53 that can either warn patient 100 of the aggravated state or instruct patient 100 to take measures to alleviate, reduce, or delay onset of the symptoms related to IBS.
• display screen 53 may instruct patient 100 to perform relaxation exercises, rest, or massage the abdomen.
• processor 50 can be programmed to correlate the aggravated state to the ingestion of certain foods via dietary inputs from patient 100 or from a doctor.
• processor 50 can be programmed to correlate the aggravated state to the ingestion of certain foods via dietary inputs from patient 100 or from a doctor.
• the present invention can be used to regulate the muscle contractions of bowel wall 14 upon determination of the aggravated through the use of a colon-pace setter. Regulation of the muscle contractions of bowel wall 14 with a colon pace-setter will reestablish normalcy of frequency, magnitude of contraction, and pattern of contraction, similar to a heart pace-maker but adapted to colon physiology. Such regulation will help alleviate the aggravated state and may help IBS symptoms subside or be reduced. [0041]
• the regulation aspect of the invention can be carried out using conventional pace-maker technology used in heart pace-makers, only adapted for colon/bowel physiology. An example of such technology can be found in United
• the colon pace-setter is preferably incorporated into solid-state manometry probe 13. However, it is possible for the colon pace-setter to be a separate device inserted into bowel cavity 15. [0042] Referring now to FIGS. 1 and 4, when the colon pace-setter is incorporated into state manometry probe 13, state manometry probe 13 will further comprise a regulation signal receiver 60. Regulation signal receiver 60 can be a radio frequency receiver. When the system is adapted to regulate colon muscular contractions, receiver 50 will function as described above. However, upon processor 52 determining an aggravated state, processor 52 will send an activation signal to regulation signal transmitter 62.
• regulation signal transmitter 62 will generate and transmit regulation signal 63 to regulation signal receiver 60 (FIG. 2).
• the colon pace-setter which is incorporated into solid-state manometry probe 13, will be activated.
• a properly programmed processor within solid-state manometry probe 13 will control the operations of the colon pace-setter.
• the colon pace-setter will use electrical impulses to control/regulate the muscle contractions of bowel wall 14. The exact electrical impulses that bowel wall 14 will be subjected to by the colon pace-setter will be based on what is determined to be normal muscle activity in that patient when in a healthy non-aggravated state.
• FIG. 5 is a flowchart of an embodiment of the method of using the system illustrated and described above in relation to FIGS. 1-4. hi order to avoid redundancy, a detail explanation of steps 600-660 will be omitted in light of the above disclosure.
• any method of data transmission can be used to transmit the pressure data from the probe to the receiver.
• pressure data can be transmitted to the receiver via a wire connection running through a catheter.

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• 2003
  • 2003-05-06 EP EP03817095A patent/EP1620009A1/de not_active Withdrawn
  • 2003-05-06 AU AU2003232040A patent/AU2003232040A1/en not_active Abandoned
  • 2003-05-06 WO PCT/US2003/013773 patent/WO2004105605A1/en active Application Filing

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