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WO2007085822A1 - Ameliorations dans et liées à la neurostimulation peripherique - Google Patents

Ameliorations dans et liées à la neurostimulation peripherique Download PDF

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Publication number
WO2007085822A1
WO2007085822A1 PCT/GB2007/000237 GB2007000237W WO2007085822A1 WO 2007085822 A1 WO2007085822 A1 WO 2007085822A1 GB 2007000237 W GB2007000237 W GB 2007000237W WO 2007085822 A1 WO2007085822 A1 WO 2007085822A1
Authority
WO
WIPO (PCT)
Prior art keywords
stimulating
electrodes
patient
needle
signal
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.)
Ceased
Application number
PCT/GB2007/000237
Other languages
English (en)
Inventor
Teodor Goroszeniuk
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.)
Individual
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Publication of WO2007085822A1 publication Critical patent/WO2007085822A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • 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
    • A61N1/328—Applying electric currents by contact electrodes alternating or intermittent currents for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
    • 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
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
    • 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
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • 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
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36071—Pain

Definitions

  • This invention relates to devices for peripheral neurostimulation for the long-term management of chronic pain and for cosmetic applications, and in particular to such percutaneous devices. It also relates to a method for performing such neurostimulation.
  • Implantable percutaneous devices usually have several discrete elements: an electrode, connections or an extension and a power source.
  • the power to an electrode can be supplied from an external battery by means of a radio frequency (RF) receiver or from internally implanted IPG battery unit.
  • RF radio frequency
  • peripheral neuromodulation technique is expected to expand during this decade.
  • the available existing systems are less than satisfactory as they are often quite large and they comprise several separate components. They generally require a surgical procedure to introduce them.
  • a percutaneous stimulating device for long-term peripheral neuromodulation in pain management and cosmetic applications comprises a stimulating zone with one or more electrodes, and an integral control unit electrically connected to the electrode(s) and capable of supplying an electrical stimulating signal to the electrode(s).
  • the device is formed of an inert material and hermetically sealed and of a substantially cylindrical form so dimensioned as to be suitable for insertion into a patient through a stimulating needle.
  • an insertion wire is attached to the outer end of the stimulating device and extends outwardly from the outer end of the stimulating needle is arranged so that in use it can be used to fine tune the positioning of the stimulating device once it has been inserted into the patent.
  • the wire is arranged so that once the device is located it can be disconnected from the device, which remains in place, and withdrawn from the patient with the stimulating needle.
  • the insertion wire may also optionally be used to provide an electrical contact with the stimulating device permitting the electrodes to be used to provide electrical stimulation so that the device can be accurately located before the insertion wire is withdrawn, leaving the stimulating device in place.
  • an external stimulating probe to locate the area where pain relief by electro-stimulation is to be applied.
  • treatment may be possible by means of external stimulation alone by applying the stimulating signal externally so that it passes through the skin to the affected area.
  • the area is accurately located by means of a stimulating needle inserted through the skin. A signal is then applied through the tip of the needle to locate the region of the affected nerve or muscle.
  • the insertion wire is stiff enough to allow it to be used as a means to push or move the device to position the electrodes at the optimum stimulating location.
  • the insertion wire may also be used to provide an electrical connection to the stimulating device both for location of the device and/or for setting the parameters of the signal applied to the electrodes to treat the pain.
  • the insertion wire is used to provide the stimulating signal to the stimulating device during its location, it needs to be insulated to avoid the current from leaking to the surrounding tissue.
  • the insertion wire can also comprise a pair of conductors so that the signal is applied through the electrodes which form part of the stimulating device; in a simpler form, the insertion wire will comprise a single conductor so that the electrical reference is provided by means of a patch which is used to provide the reference contact for the stimulating needle.
  • This procedure also minimises any surgical trauma resulting from the insertion of this type of unit.
  • the use of the insertion wire to move and adjust the stimulating device permits a level of accuracy in positioning the device hitherto difficult to achieve and thus greatly enhances the efficacy of the device and the resulting pain relief.
  • the device is thus intended to remain in place permanently, or at least for many weeks or months which is made possible either by the use of suitable long-life or rechargeable batteries, or by means of a radio frequency (RF) signal to the implanted device.
  • RF radio frequency
  • the RF signal is arranged to recharge the battery to give the patient autonomy from using an external unit.
  • the RF signal is converted to the required amplitude and frequency within the stimulating device and applied to the electrode(s). It is thus possible to apply the RF output directly to control the electrodes and/or to provide the energy for the device.
  • the diameter of the device will not be greater than 2mm and preferably 1.5mm, and ideally less than 1.2mm to permit its insertion through a stimulating needle. It will be less than 70mm long so that it can be inserted through a normal stimulating needle, and preferably less than 40mm, though for cosmetic applications shorter versions of less than 20mm or even as short as 6mm may be required. As electronic components become smaller even smaller versions may become feasible, and the cost of the device is likely to decrease significantly.
  • the power supply which forms a part of the device may be chosen from a selection of different models in order to suit the application and the patient's needs.
  • the power supply is detachable from the stimulating element of the device allowing a practitioner to select a suitable power supply which can be attached to the stimulating element by means of a screw thread, clip or other means.
  • a choice may be made between long-life batteries, rechargeable batteries or an RF unit.
  • the battery or the RF unit may be too wide or bulky for it to be inserted through a stimulating needle. If this is the case, the stimulating element of the device may be inserted first through the stimulating needle and the battery or RF unit to be attached to the stimulating element in situ after it has been inserted and located (using a signal passed along the insertion wire). Such attachment and implantation of the power supply to the stimulating element may however require a small incision.
  • the preferred stimulation frequency range of the device is between 1 and 50Hz and optimally between 2 and 10Hz. This low frequency has a particularly beneficial effect on the treatment of chronic pain.
  • a current of between 0.15 and 15 mA and preferably between 2 and 10 mA is found to be very successful.
  • a square wave is used and the wave duration is typically from 0.5 to 1 ms though it may be as short as 0.05 ms, or as long as 10 or 12 ms depending on the extent and the severity of the pain to be treated, and the response of the patient to the treatment.
  • the device may fail, or otherwise need to be removed it is conveniently be provided with a drawstring at the end opposite to the stimulating zone to enable it to be removed from a patient if required without the need for a surgical procedure, although a small incision may be necessary.
  • the draw-string is ideally opaque to X- rays to facilitate its location.
  • a stimulating needle ready for percutaneous insertion into a patient is intended in practice to be supplied as an assembly with the insertion wire attached to the stimulating device already inside the needle and with all the necessary electrical connections.
  • the invention extends equally to a method of treating chronic pain by identifying the location to be treated by inserting a stimulating needle connected to an appropriate external stimulating source, applying a stimulating current or signal, and then inserting a miniature stimulating device or capsule through the needle.
  • the position of the miniature stimulating device is fine tuned by means of a rigid or semi-rigid wire connected to it and allowing it to be moved while a stimulating signal is passed down the wire or while the device itself is activated.
  • Figure 1 is a diagrammatic view of a percutaneous stimulating device in accordance with the invention in the process of being inserted into a patient.
  • a percutaneous stimulating device 10 for long-term peripheral neuromodulation in pain management and cosmetic applications comprises a stimulating element 12 with one or more pairs of electrodes including an integral control unit powered by a power supply 14.
  • the integral control unit is arranged to supply an electrical stimulating signal to the electrodes.
  • the electrodes 12 may either be arranged as pairs of electrodes or as a number of stimulating electrodes with one or more reference electrodes.
  • the device is formed of an inert material and hermetically sealed and of a substantially cylindrical form so dimensioned as to be suitable for insertion into a patient through a stimulating needle 16.
  • a semi-rigid insertion wire 18 attached to the outer end of the device 10 and extending outwardly from the outer end of the stimulating needle 16 is arranged so that in use it can be used to fine tune the positioning of the stimulating device.
  • the wire 18 is formed so that once the device is located in a patient it can be disconnected from the device which remains in place. The wire 18 is then withdrawn with the needle. The entry point of the insertion wire into the stimulating device is self-sealing maintain a hermetic seal of the device.
  • the stimulating device 10 is a self-contained permanent or long-term unit for neuromodulation in the management of chronic pain and for cosmetic applications.
  • An integral control unit 14 with a power supply is built into the outer end of the stimulating device and is capable of supplying an electrical stimulating signal to the electrodes 12 over a prolonged period of many months.
  • the body of the device is generally cylindrical having a diameter of 1.2 to 1.5mm. It is between 20 and 70mm in length depending on its intended application. For facial or cosmetic applications however it may be as short as 6mm.
  • the stimulating needle 16 is electrically connected to an external locating stimulator 20 by a lead 22 which is supplied with the stimulating needle ready for connection to the locating stimulator 20.
  • a patch 24 is also connected to the locating stimulator 20 by a wire 28 and stuck to the skin 30 of a patient to make an electrical contact as a reference electrode. In most cases an external locating device will have been used to provide an initial location of the area to be treated.
  • the locating stimulator 20 is than set to provide a low-level signal to the stimulating needle 22 which is inserted into the patient.
  • the patient feels a beneficial effect as the signal at the uninsulated end 32 of the needle as it nears the affected area.
  • the stimulating device is then activated and the final adjustment of its location is made by means of the insertion wire 18 so that the electrodes 12 on the stimulating device are optimally placed to treat the pain while a signal is transmitted through the wire or the device itself is activated to send a signal to the electrodes.
  • Equally, fine tuning of the stimulating signal in terms of power (mA), frequency and pulse duration may be adjusted by a practitioner in response to the patient.
  • the stimulating signal during location of the stimulating device 10, can either be supplied from the locating stimulator 20 to the stimulating device through the insertion wire 18 and the patch 28, by means of its own battery or by an external RF device (not shown).
  • the frequency and the intensity of the signal supplied to the tip 32 of the stimulating needle, or to the electrodes on the stimulating device can be adjusted on the stimulating locator 20 by standard means, from say 1 to 20 Hz and from 0.1 to 15mA though more usually less than 10mA, as required to produce the optimum level of relief.
  • the signal is of a square waveform and has a duration of 0.5 to 1 ms of each cycle. The actual values will be determined by a skilled practitioner according to the location, extent and severity of the pain to be treated, and will depend on the response of the patient to the treatment.
  • the applied current will depend on the severity of the pain and the duration of the pulse, ie. the applied energy, will be determined by the extent of the pain to be treated.
  • the frequency is selected by the practitioner in response to feedback from the patient on their preferences and the effectiveness of the treatment. In most cases the patient will indicate a preference for a frequency of 2 to 10 Hz.
  • the device is thus intended to remain in place permanently, or at least for many weeks or months which is made possible either by the use of suitable long-life or rechargeable batteries, or by means of a radio frequency (RF) signal to a transformer forming part of the control unit on the stimulating device.
  • RF radio frequency
  • the battery receives its charge from an external RF unit to give the patient autonomy from always having to use an external unit when treatment is required.
  • the stimulating device 10 receives its charge from an external RF source and converts the signal to the required amplitude and frequency for the electrodes. It is also possible to apply the RF output directly to control the electrodes and/or to provide the energy for the device.
  • the device As the device has a finite life and sooner or later will need to be removed, it is provided with a draw-string 36 which is buried under the skin with the device.
  • the draw-string has a loop 38 at its outer end and is opaque to X-rays so that it can be easily located to allow the device to be removed after making a small incision.
  • the power supply which forms a part of the device may be chosen from a selection of different models in order to suit the application and the patient's needs.
  • the power supply is thus detachable from the stimulating element of the device with the electrodes allowing a practitioner to select a suitable power supply which can be attached to the stimulating element by means of a screw thread, clip or other means. In practice this has the advantage of allowing the practitioner to make a choice between long-life batteries, rechargeable batteries or an RF unit as best to suit a patient's needs.
  • the battery or the RF unit may be too wide or bulky for it to be inserted through a stimulating needle. If this is the case, the stimulating element of the device with the electrodes 12 may be inserted first through the stimulating needle and the battery or RF unit to be attached to the stimulating element in situ after it has been inserted. The electrodes may nevertheless still be located by using a signal passed along the insertion wire. Such attachment and implantation of the power supply to the stimulating element may however require a small incision.
  • the percutaneous device is placed in its desired position by applying a suitable signal to a stimulating needle and preferably through the device itself as described above.
  • a specialist doctor or practitioner determines the area of implantation and the ranges of the stimulating frequency and current. Where there is an RF connection between the device and an external unit the patient has a greater choice of use of the device to provide relief. He or she will also be able to vary the frequency and current within the parameters preset by the specialist practitioner to obtain optimum relief.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Plastic & Reconstructive Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un dispositif (10) de stimulation percutanée comportant une unité intégrée à demeure ou à long terme pour la neuromodulation dans la gestion de la douleur chronique et pour des applications cosmétiques, comportant un élément stimulateur doté d'une ou plusieurs électrodes (12), et une unité de commande incorporée. Le dispositif se présente sous la forme d'un cylindre fermé d'un diamètre de moins de 1,2 à 1,5 mm et ne dépassant pas 70 mm de longueur, de sorte qu'il peut être positionné et inséré dans un patient à travers une aiguille de stimulation au moyen d'un fil d'insertion, qui peut être utilisé pour faire passer un courant stimulant jusqu'au dispositif afin de le positionner précisément. L'aiguille de stimulation et le fil d'insertion sont ensuite retirés du patient lorsque le dispositif est en place. L'invention s'étend à un procédé de gestion de la douleur à long terme au moyen d'une neuromodulation à l'aide du dispositif percutané en accord avec l'invention pour fournir un signal de stimulation entre 2 et 50 Hz.
PCT/GB2007/000237 2006-01-25 2007-01-24 Ameliorations dans et liées à la neurostimulation peripherique Ceased WO2007085822A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0601462.5 2006-01-25
GB0601462A GB2434539A (en) 2006-01-25 2006-01-25 Implanted pain relieving nerve stimulator with insertion wire acting as temporary power cable

Publications (1)

Publication Number Publication Date
WO2007085822A1 true WO2007085822A1 (fr) 2007-08-02

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ID=36060807

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2007/000237 Ceased WO2007085822A1 (fr) 2006-01-25 2007-01-24 Ameliorations dans et liées à la neurostimulation peripherique

Country Status (2)

Country Link
GB (2) GB2434539A (fr)
WO (1) WO2007085822A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10881850B2 (en) 2012-03-06 2021-01-05 Medtronic, Inc. Self-tunneling lead
US11471683B2 (en) 2019-01-29 2022-10-18 Synapse Biomedical, Inc. Systems and methods for treating sleep apnea using neuromodulation

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2546651B1 (es) * 2014-03-24 2016-11-16 Ionclinics And Deionic, S.L. Dispositivo para la recuperación de tendinopatías y roturas fibrilares

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5007902A (en) * 1988-03-09 1991-04-16 B. Braun Melsungen Ag Catheter set for plexus anesthesia
WO1997029802A2 (fr) * 1996-02-20 1997-08-21 Advanced Bionics Corporation Microstimulateur implantable ameliore et systemes d'utilisation associes
US6428368B1 (en) * 2001-03-26 2002-08-06 Pacesetter, Inc. Side actuated lead connector assembly for implantable tissue stimulation device
WO2003032807A2 (fr) * 2001-10-19 2003-04-24 Alfred E. Mann Foundation For Scientific Research Systeme et procede de retrait d'un dispositif implante
US20050085870A1 (en) * 2003-10-20 2005-04-21 Teodor Goroszeniuk Peripheral neurostimulation

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4285347A (en) * 1979-07-25 1981-08-25 Cordis Corporation Stabilized directional neural electrode lead
US6735474B1 (en) * 1998-07-06 2004-05-11 Advanced Bionics Corporation Implantable stimulator system and method for treatment of incontinence and pain
US20010025192A1 (en) * 1999-04-29 2001-09-27 Medtronic, Inc. Single and multi-polar implantable lead for sacral nerve electrical stimulation
US7949395B2 (en) * 1999-10-01 2011-05-24 Boston Scientific Neuromodulation Corporation Implantable microdevice with extended lead and remote electrode

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5007902A (en) * 1988-03-09 1991-04-16 B. Braun Melsungen Ag Catheter set for plexus anesthesia
WO1997029802A2 (fr) * 1996-02-20 1997-08-21 Advanced Bionics Corporation Microstimulateur implantable ameliore et systemes d'utilisation associes
US6428368B1 (en) * 2001-03-26 2002-08-06 Pacesetter, Inc. Side actuated lead connector assembly for implantable tissue stimulation device
WO2003032807A2 (fr) * 2001-10-19 2003-04-24 Alfred E. Mann Foundation For Scientific Research Systeme et procede de retrait d'un dispositif implante
US20050085870A1 (en) * 2003-10-20 2005-04-21 Teodor Goroszeniuk Peripheral neurostimulation

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10881850B2 (en) 2012-03-06 2021-01-05 Medtronic, Inc. Self-tunneling lead
US11471683B2 (en) 2019-01-29 2022-10-18 Synapse Biomedical, Inc. Systems and methods for treating sleep apnea using neuromodulation

Also Published As

Publication number Publication date
GB0601462D0 (en) 2006-03-08
GB0701405D0 (en) 2007-03-07
GB2434547B (en) 2011-05-11
GB2434539A (en) 2007-08-01
GB2434547A (en) 2007-08-01

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