EP1313529A2 - Procede et sonde destinee aux cavites du corps - Google Patents

Procede et sonde destinee aux cavites du corps

Info

Publication number
EP1313529A2
EP1313529A2 EP01950195A EP01950195A EP1313529A2 EP 1313529 A2 EP1313529 A2 EP 1313529A2 EP 01950195 A EP01950195 A EP 01950195A EP 01950195 A EP01950195 A EP 01950195A EP 1313529 A2 EP1313529 A2 EP 1313529A2
Authority
EP
European Patent Office
Prior art keywords
hollow member
body cavity
probe
electrically
tissue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP01950195A
Other languages
German (de)
English (en)
Inventor
Gad Alon
Avraham Cohen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SN Sophisticated Fabrics AB
Original Assignee
SN Sophisticated Fabrics AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/631,123 external-priority patent/US6625495B1/en
Priority claimed from SE0003821A external-priority patent/SE519374C2/sv
Application filed by SN Sophisticated Fabrics AB filed Critical SN Sophisticated Fabrics AB
Publication of EP1313529A2 publication Critical patent/EP1313529A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0521—Genital electrodes
    • A61N1/0524—Vaginal electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0507—Electrodes for the digestive system
    • A61N1/0512—Anal electrodes

Definitions

  • the present invention relates to probes insertable into a body cavity for various purposes, as will be described more particularly below, and also to a method of utilizing such a probe for the various purposes described below.
  • the invention may be used to apply any combination of electrical stimulation, pressure biofeedback, and microcirculation biofeedback for therapeutic purposes as well as to make measurements of pelvic floor muscular and vascular impairments.
  • the therapeutic purposes include treating for impairments or dysfunsctions of the neuro- muscular, neuro-vascular, peripheral vascular systems associated with bladder and fecal incontinence, disuse atrophy and weakness of the pelvic floor musculature, pelvic pain, erectile dysfunction, and orgasm.
  • pelvic floor dysfunction it is well know to apply electrotherapy over the pelvic floor surface, or within the vagina or rectum, in order to improve, ameliorate or prevent impairments of the pelvic floor such as muscle disuse atrophy, urine or bowel incontinence, or pelvic pain, hereinafter collectively referred to as pelvic floor dysfunction; see for example: FALL, Magnus, Advantages and Pitfalls of Functional Electrical Stimulation, Acta Obstet Gynecol Scand 1998; Supplement 168: 77:16-21; and BO, Karl, Effect of Electrical Stimulation on Stress and Urge Urinary Incontinence, Acta Obstet Gynecol Scand 1998; Supplement 168: 77:3-11, both hereby incorporated herein by reference.
  • FALL Magnus, Advantages and Pitfalls of Functional Electrical Stimulation, Acta Obstet Gynecol Scand 1998; Supplement 168: 77:16-21
  • BO Karl, Effect of Electrical Stimulation on Stress and Urge Urinary Incontinence, Acta Obste
  • An object of the present invention is to provide a body-cavity probe having advantages in one or more of the above respects. Another object of the invention is to provide a method for utilizing such a probe in order to treat for any one of a plurality of pelvic floor dysfunctions.
  • a probe insertable into a body cavity for applying an electrical stimulation to tissue therein comprising: a hollow member of flexible biocompatible material to enable the member to be inserted into the body cavity and to substantially conform to its inner surface, and thereby, to contact the tissue therein to be stimulated; at least at a portion of the outer surface of the hollow member being electrically conductive to enable an electrical voltage to be applied thereto for electrically stimulating the tissue within the body cavity contacted by the electrically conductive surface.
  • the hollow member includes at least two sections of electrically-conductive biocompatible material separated from each other by sections of electrically-insulating biocompatible material.
  • the hollow member is made of sections of electrically-conductive and electrically- insulating silicon resin.
  • the hollow member is of tubular configuration, closed at one end and open at the opposite end to face the outer end of the body cavity to permit a fluid within the hollow member to be expelled, and thereby to permit the hollow member to substantially conform to the inner surface of the body cavity.
  • the hollow member further includes a central spine of relatively stiff material extending through the interior of the hollow member.
  • One end of the central spine includes a dome-shaped tip engaging the inner surface of the closed end of the hollow member, and the opposite end of the central spine includes a base secured to the open end of the hollow member.
  • the base of the central spine includes an enlarged plate to be located externally of the body cavity and thereby to limit the penetration of the hollow member into the body cavity.
  • the dome shaped tip of the central spine is electrically-conductive, and the closed end of the hollow member is also electrically-conductive.
  • the central spine may be used for supporting the electrical conductors to the respective electrically-conductive sections of the hollow member.
  • the base includes a tube having one end communicating with the interior of the hollow member for the passage of fluids thereinto or therefrom, and an opposite end leading out of the hollow member and of the body cavity when the hollow member is inserted therein.
  • the opposite end of the tube is connected to a fluid pressure measuring device for measuring the fluid pressure within the hollow member, and thereby the pressure applied to the hollow member by the tissue within the body cavity contacted by the hollow member.
  • a probe insertable into a body cavity for sensing a condition therein comprising: a hollow member of flexible biocompatible material such that the member, upon insertion into the body cavity, substantially conforms to the inner surface of the body cavity; at least a portion of the hollow member being optically transparent; and an optical sensor within the hollow member and aligned with the transparent section to optically sense a condition within the body cavity.
  • a method of applying electrical stimulation to tissue within a body cavity comprising: inserting into the body cavity a hollow member of flexible biocompatible material such that the hollow member substantially conforms to the inner surface of the body cavity and contacts the tissue therein to be stimulated, at least a portion of the outer surface of the hollow member being electrically conductive; and applying an electrical voltage to the electrically-conductive surface of the body member for electrically stimulating the tissue within the bocavity contacted by the electrically conductive surface.
  • a method of sensing a condition of tissue within a body cavity comprising: inserting into the body cavity a hollow member of flexible biocompatible material substantially conforming to the inner surface of the body cavity and thereby contacting the tissue therein whose condition is to be sensed, at least a portion of the hollow member being optically transparent, there being an optical sensor within the hollow member in alignment with the optically-transparent section; and utilizing the optical sensor for optically sensing a condition within the body cavity.
  • Fig. 1 is a side view illustrating one form of probe constructed in accordance with the present invention
  • Fig. 2 is a view, partly in section, more particularly illustrating the construction of a probe in accordance with the present invention
  • Fig. 3 illustrates a system, including the probe of Fig. 2, for electrically stimulating the muscles of the pelvic floor or for measuring the contractile force applied by the muscular tissue thereat;
  • Fig. 4 illustrates a system, similar to that of Fig. 3, but also including an optical sensor for sensing a condition within the body cavity, such as the flow or oxygen- content of blood flowing through tissue therein.
  • the probe illustrated in Figs. 1 - 3 of the drawings and therein generally designated 2 is designed for insertion into a body cavity, such as the vagina of a female or the anus of a female or male, for applying an electrical stimulation to the muscles of the pelvic floor, and/or for measuring a condition therein, e.g., for the treatment of any one of a plurality of pelvic floor dysfunctions, such as urine and fecal incontinence, pelvic pain, erectile dysfunction, and orgasm.
  • a body cavity such as the vagina of a female or the anus of a female or male
  • an electrical stimulation to the muscles of the pelvic floor
  • a condition therein e.g., for the treatment of any one of a plurality of pelvic floor dysfunctions, such as urine and fecal incontinence, pelvic pain, erectile dysfunction, and orgasm.
  • It includes a flexible hollow member of a flexible biocompatible material which, when inserted into the respective body cavity (e.g., vagina or anus), substantially conforms to the inner surface of the body cavity so as to be in contact with the tissue therein to be stimulated or to be examined.
  • a body cavity e.g., vagina or anus
  • a particularly suitable material is a biocompatible silicon resin, such as used in baby nipples, pacifiers, and the like, providing a structure which is substantially self- supporting but sufficiently flexible and supple so as to respond readily to changes in the surface of the body cavity into which the hollow member is inserted.
  • the flexible hollow probe 2 is substantially self-supporting, it is provided with a central spine, generally designated 3, serving to further support the hollow probe, as well as to provide other functions during the use of this probe for stimulation and/or measurement purposes, as will be described more particularly below.
  • the flexible hollow probe 2 is made of four sections, all joined together, to produce a tubular configuration closed at one end and open at the other end.
  • hollow probe 2 includes a dome-shaped section 21 at the closed end joined by two annular sections 22, 23, the latter being joined to another section 24 constituting the open end of the hollow probe.
  • All four sections 21 - 24 of the hollow probe 2 are preferably made of a biocompatible silicon resin and are joined in any suitable manner, as by a suitable adhesive.
  • Sections 21 and 23, however, of the hollow probe are made electrically-conductive, as by the provision of electrically- conductive particles, preferably carbon, in the resin. Such electrically-conductive particles are not included in the resin to produce section 22 and 24, so that those sections are electrically-insulating, and thereby insulate the two electrically-conductive sections 21 and 23 from each other.
  • the flexible hollow probe 2 may be made of medical grade silicon of a thickness of 0.1 to 2 mm, of a diameter (D) that may range from 10 mm to 40 mm, and a length (L) that may range from 30 to 150 mm, depending on the specific application of the probe.
  • the central spine 3 is made of a stiff material, such as plastic, but is not limited to this material. It may have a diameter ranging from 2 mm to 10 mm, and extends for the complete length (L) of the hollow probe 2. Its inner end or tip 31 is dome-shaped, conforming to the dome-shaped section 21 of the hollow probe, and is made of electrically-conductive material, such as copper or stainless steel, to provide good electrical contact with the electrically-conductive section 21 of the hollow probe.
  • the opposite end of the stem 3 is formed as a base 32 of stiff rigid material and is secured to the open end of the flexible hollow probe 2.
  • the base 32 is further secured to an enlarged plate 33 externally of the hollow probe 2 so as to be located externally of the body cavity in which the hollow probe is inserted, to limit the penetration of the hollow probe 2 into the body cavity.
  • the central spine 3 further includes a cable 34 having one electrical conductor connected to the electrically-conductive dome 31 in contact with the electrically- conductive end 21 of the flexible hollow probe 2, and another electrical conductor connected to the electrically-conductive section 23 of the hollow probe. As shown in Fig. 3, cable 34 is connected to an electrical stimulator 35 which applies the electrical voltages to the electrically-conductive sections 21 and 23 of the hollow probe 2 for stimulating the muscle tissue in contact with those sections of the hollow probe.
  • the flexible hollow probe 2 further includes a fluid tube 36 having one end communicating with the interior of the hollow probe, and the opposite end communicating with a pressure-measuring device, shown at 37 in Fig. 3.
  • tube 36 is connected to the pressure-measuring device 37 via a fitting 40, which may be of a Y-type or a T-type, including an inlet 41 and two outlets 42, 43.
  • Outlet 42 is connected via a valve Vi to the inlet tube 44 to the pressure measuring device 37.
  • Outlet 43 is connected via a second valve V 2 to the atmosphere.
  • Valve Vi is a simple shut-off valve which may be opened or closed; whereas valve V 2 is one-way valve which, when opened, allows fluid to pass only outwardly into the atmosphere as shown by the arrow, but may also be closed.
  • the probe illustrated in Figs. 1 - 3 may be used in the following manner. With valve Y ⁇ closed, and valve V 2 opened, the flexible hollow probe 2 is inserted into the body cavity, e.g., vagina or anus, to be electrically stimulated or examined. Since valve V 2 is opened, it permits the exit of air caused by the contraction of the probe when conforming its outer surface to the inner surface of the body cavity.
  • the body cavity e.g., vagina or anus
  • valve V 2 is closed, and valve Vi is opened, thereby establishing two-way communication between the interior of the probe and the fluid pressure measuring device 37. Accordingly, contractions or relaxations of the muscle tissue contacted by the outer surface of the probe will cause changes in pressure within the probe, which changes in pressure will be measured by the pressure measuring device 37.
  • the electrical stimulator 35 may be operated to apply electrical voltages to the electrically-conductive sections 21 and 23 of the probe, to thereby stimulate the tissue in contact with those sections of the probe.
  • the stimulator 35 may be one of the commercially available neuromuscular electrical stimulators (NMES). It can be used to stimulate the pelvic floor musculature and, simultaneously or independently, measure the contractile force of the pelvic floor musculature. The measured force may be displayed on the display unit and used to provide the subject with immediate or delayed information, analog or digital, regarding the results. It likewise provides the clinician with objective measurements of pelvic floor contractile force.
  • NMES neuromuscular electrical stimulators
  • the measuring unit 37 may also be a commercially available device.
  • Such devices commonly include pressure sensors, standard analog-to-digital circuitry that converts the pressure-generated voltage changes into digital output, and electronic displays. Examples of such devices are those supplied by Enteran Devices, Inc., of
  • the subject inserts the probe into the vagina or rectum.
  • the measuring unit is calibrated to zero (0) pressure, and the measurements of pressure changes and time of contraction are recorded and stored.
  • the subject To activate the stimulator, the subject connects the two leads of the stimulator output to the probe, and increases stimulator intensity using the appropriate stimulus parameters to induce excitation of sensory and motor nerves (or direct excitation of muscle fibers) that results in either twitch or tetanic muscle contraction.
  • the subject can then use the probe to only stimulate or to only measure volitional or spontaneous contraction force of the pelvic floor, or can combine the stimulation with the force measurements.
  • Fig. 4 illustrates a variation in the construction of the probe of Figs. 1 - 3.
  • one of the insulating sections of the probe may be made light-transparent and used for mounting an optical sensor within the probe.
  • Fig. 4 illustrates this transparent section identified by the reference numeral 52, and the optical sensor 53 mounted thereon and in optical alignment therewith.
  • the optical sensor may be, for example, an oximeter to optically sense the flow, or oxygen- content, of the blood flowing through tissue in the body cavity contacted by section 52 of the probe.
  • oximeter 53 is connected to electrical measuring system 54 for measuring the optical condition sensed by the oximeter, and for translating such measurements into blood flow, oxygen-content, or any other condition for which oximeters are commonly used.
  • the invention may be used only for one or two of the above- described functions, i.e., for applying electrical stimulation to tissues within a body cavity, and/or for using pressure-sensitive means for measuring changes in the body cavity and/or for using optical-sensing means for measuring changes in the body cavity.
  • the probe is shown as being filled with air, it could be filled with another fluid, such as a saline liquid, to make the probe more sensitive to pressure variations, but in such case the inner surfaces of the electrically-conductive sections of the probe would have to be insulated.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Une sonde (2) insérable dans une cavité du corps permet d"appliquer une stimulation électrique aux tissus de cette cavité. Cette sonde comprend un élément creux flexible (2) réalisé en matériau biocompatible et destiné à être inséré dans la cavité du corps dont il épouse sensiblement la surface interne, entrant ainsi en contact avec les tissus à stimuler. Une partie de la surface externe de l"élément creux (2) est électro-conductrice, ce qui permet d"y appliquer une tension électrique destinée à la stimulation électrique des tissus de la cavité du corps, ces tissus étant en contact avec ladite surface électroconductrice. La sonde (2) peut également comporter une section transparente et un capteur optique, tel qu"un oxymètre, destinés à l"examen optique des tissus de la cavité du corps.
EP01950195A 2000-08-02 2001-07-17 Procede et sonde destinee aux cavites du corps Withdrawn EP1313529A2 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US09/631,123 US6625495B1 (en) 2000-08-02 2000-08-02 Body-cavity probe with body conformable member
US631123 2000-08-02
SE0003821A SE519374C2 (sv) 2000-10-23 2000-10-23 Prob införbar i en kroppskavitet samt metod
SE0003821 2000-10-23
PCT/SE2001/001640 WO2002009805A2 (fr) 2000-08-02 2001-07-17 Procede et sonde destinee aux cavites du corps

Publications (1)

Publication Number Publication Date
EP1313529A2 true EP1313529A2 (fr) 2003-05-28

Family

ID=26655270

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01950195A Withdrawn EP1313529A2 (fr) 2000-08-02 2001-07-17 Procede et sonde destinee aux cavites du corps

Country Status (3)

Country Link
EP (1) EP1313529A2 (fr)
AU (1) AU2001271220A1 (fr)
WO (1) WO2002009805A2 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0523917D0 (en) 2005-11-24 2006-01-04 Femeda Ltd Devices for electrostimulation
GB0523918D0 (en) 2005-11-24 2006-01-04 Femeda Ltd Self contained device with treatment cycle for electrostimulation
GB0523916D0 (en) 2005-11-24 2006-01-04 Femeda Ltd Compressible electrodes
GB201414695D0 (en) 2014-08-19 2014-10-01 Femeda Ltd Electrostimulation related devices and methods
US10105531B2 (en) 2015-09-07 2018-10-23 Femeda Ltd. Device for electrostimulation

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5385577A (en) * 1992-11-12 1995-01-31 Empi, Inc. Electrode for activating pelvic reflexes
GB2301287B (en) * 1992-05-23 1997-02-05 Keith Edward Tippey Electrical stimulation for treatment of incontinence and other neuro-muscular disorders
FR2790379B1 (fr) * 1999-03-05 2001-06-08 Michel Guerineau Dispositif de reeducation de mesure de forces musculaires perineo-sphincteriennes

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0209805A3 *

Also Published As

Publication number Publication date
WO2002009805A3 (fr) 2002-07-18
AU2001271220A1 (en) 2002-02-13
WO2002009805B1 (fr) 2002-08-29
WO2002009805A2 (fr) 2002-02-07

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