WO2003033068A2 - Electro-nerve stimulator system and methods - Google Patents

Electro-nerve stimulator system and methods Download PDF

Info

Publication number
WO2003033068A2
WO2003033068A2 PCT/US2002/033318 US0233318W WO03033068A2 WO 2003033068 A2 WO2003033068 A2 WO 2003033068A2 US 0233318 W US0233318 W US 0233318W WO 03033068 A2 WO03033068 A2 WO 03033068A2
Authority
WO
WIPO (PCT)
Prior art keywords
electrically conductive
lead wire
pulse generator
electrode
needle electrode
Prior art date
Application number
PCT/US2002/033318
Other languages
French (fr)
Other versions
WO2003033068A3 (en
Inventor
Jeffrey M. Williams
Fred Van Aart
Hans Van Den Biggelaar
Piet Van Helvoirt
Original Assignee
Cystomedix, Inc.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23314453&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2003033068(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to US10/492,578 priority Critical patent/US7536226B2/en
Priority to AT02786437T priority patent/ATE536907T1/en
Priority to EP02786437A priority patent/EP1444004B1/en
Priority to AU2002349957A priority patent/AU2002349957A1/en
Priority to DK02786437.0T priority patent/DK1444004T3/en
Application filed by Cystomedix, Inc. filed Critical Cystomedix, Inc.
Priority to ES02786437T priority patent/ES2377946T3/en
Priority to CA2463936A priority patent/CA2463936C/en
Publication of WO2003033068A2 publication Critical patent/WO2003033068A2/en
Publication of WO2003033068A3 publication Critical patent/WO2003033068A3/en
Priority to US11/804,200 priority patent/US8812114B2/en
Priority to US14/322,525 priority patent/US9056194B2/en
Priority to US14/682,564 priority patent/US9265941B2/en

Links

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
    • A61N1/36014—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
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • 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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3752—Details of casing-lead connections

Definitions

  • the present invention relates generally to electro-nerve stimulation and more particularly to electro-nerve stimulation systems utilizing transcutaneous and percutaneous electrodes. Description of the Related Art:
  • An electro-nerve stimulation system is disclosed in U.S. Patent Application No. 09/213,558 comprising a pulse generator electrically coupled by lead wires to an electrically conductive transcutaneous electrode (i.e., an electrode which does not penetrate the surface of the skin) and an electrically conductive percutaneous needle electrode (i.e., an electrode which penetrates the surface of the skin).
  • the transcutaneous electrode is positioned distally proximate the stimulation site.
  • the percutaneous electrode needle is positioned to penetrate the patient's skin and is advanced into proximity with the stimulation site.
  • electrical current pulses from the pulse generator traverse the internal stimulation site by passing from the transcutaneous electrode to the percutaneous needle.
  • This type of electro-nerve stimulation system disclosed in the '558 application has been found to be effective for both nerve and muscle stimulation for treatment of numerous conditions, including urge incontinence, chronic pain, Parkinson's disease, multiple sclerosis and for general muscle and joint rehabilitation.
  • electro-nerve stimulation system as disclosed in the above referenced '558 application serves its intended purpose, non-medical professionals who use the system for self treatment and for treating others, may not readily appreciate the health risks associated with re-using the same electrodes that may have come in contact with another person's skin and bodily fluids. Accordingly, there is a need in the industry for an electro-nerve stimulation system which provides the features and advantages disclosed in the above referenced '558 application, but which is designed to effectively prevent the electrodes from being reused for a second treatment. To the accomplishment effectively preventing reuse of the electrodes, the retail cost of disposable electrodes and their associated lead wires must be relatively inexpensive so that any perceived benefit in attempting to reuse the disposable electrodes is outweighed by the difficulty in attempting to do so.
  • the present invention is an electro-nerve stimulation system comprising a pulse generator electrically coupled by first and second electrically conductive insulated lead wires to an electrically conductive transcutaneous electrode and an electrically conductive percutaneous needle electrode, respectively.
  • One end of each of the first and second electrically conductive, insulated lead wires are preferably fixedly secured to a single male keyed connector which is matingly receivable by a single female keyed receptacle on the pulse generator.
  • the other end of the first lead wire is fixedly secured to the electrically conductive transcutaneous electrode.
  • One face of the transcutaneous electrode includes an electrically conductive medical grade adhesive to removably adhere the electrode to the patient's skin near the desired stimulation site.
  • an electrically conductive adaptor Fixedly secured to the other end of the second lead wire is an electrically conductive adaptor.
  • the electrically conductive adaptor is a tape member.
  • the electrically conductive tape member preferably includes an electrically conductive adhesive portion and a non-adhesive portion.
  • the percutaneous needle electrode is preferably fixedly securable to the tape member by folding the adhesive portion of the tape member over the end of the percutaneous needle extending from the patient's skin.
  • the transcutaneous electrode with the first lead wire secured thereto is positioned and adhered to the patient's skin distally proximate the stimulation site.
  • the percutaneous needle electrode which is not yet electrically connected to the electrically conductive tape member, is positioned to penetrate the patient's skin and is advanced into proximity with the stimulation site.
  • the first ends of the lead wires are electrically connected to the pulse generator by inserting the preferred single male connector into the mating female receptacle of the pulse generator.
  • the pulse generator is activated.
  • the end of the percutaneous needle electrode projecting outwardly from the patient's skin is placed and held in contact with the non-adhesive portion of the electrically conductive tape.
  • the position of the percutaneous needle electrode is manipulated as needed until it is determined that the percutaneous needle is at the desired location in proximity to the desired stimulation site.
  • the needle is preferably fixedly secured to the electrically conductive tape by folding the ends of the adhesive portion of the electrically conductive tape member over the projecting end of the needle electrode thereby forming an electrical connection therebetween. In this configuration, current pulses generated by the pulse generator traverse the internal stimulation site from the transcutaneous needle electrode to the percutaneous needle electrode.
  • the adhesive on the face of the transcutaneous electrode for adhering to the patient's skin is preferably a single-use adhesive in that it will lose its adhesive properties upon removal such that it will not readily re-adhere to the patient's skin, thereby effectively rendering the transcutaneous electrode to a single use.
  • the electrically conductive tape member is also preferably adapted for only a single use in that once the ends of the adhesive portion of the tape member is folder over the end of the percutaneous needle electrode, the folded ends of the tape member cannot be readily reopened for removal of the percutaneous needle adhered therein without damaging the tape member.
  • the preferred single male connector is adapted for only a single use.
  • the connector includes a fuse which will burn out after a preselected time period, thereby rendering the connector incapable of making an electrically conductive connection with the lead wire interfaces of pulse generator.
  • the pulse generator may generate a current spike to burn out the fuse.
  • a serial read/write non-volatile EPROM chip may be incorporated into the connector which is programmable to prevent an electrical connection with the lead wire interface of the pulse generator after a predetermined time period.
  • the connector may incorporate both a serial read/write non- volatile EPROM and a fuse in which the EPROM is programmable to burn out the fuse after a preselected time period or to generate a spike to burn out the fuse after expiration of a preselected time period.
  • the adaptor secured to the second end of the second lead wire may be a clip for connecting with the terminal end of the percutaneous needle electrode.
  • the clip is preferably designed to fail after one use.
  • the clip may have a bridge member movable between an open position and a closed position by depressing the plunger. As current pulses from the pulse generator traverse the bridge member, the bridge member may burn out preventing its reuse, or alternatively, the bridge member may fixedly bond or weld to the terminal end of the percutaneous needle electrode preventing reuse of the electrode and clip.
  • this embodiment may also be used with one or more of the alternative single-use connector embodiments described above. If a single-use connector is used, the clip need not be a single-use clip.
  • FIG. 1 illustrates the preferred embodiment of the electro-nerve stimulator system of the present invention.
  • FIG. 2 is an exploded cross-sectional view of the prefened embodiment of the transcutaneous electrode of the present invention.
  • FIG. 3 is an exploded cross-sectional view of the prefened embodiment of the electrically conductive tape member of the present invention.
  • FIG. 4 illustrates the positioning of the terminal end of the percutaneous needle electrode onto the adhesive portion of the electrically conductive tape member of the present invention.
  • FIG. 5 illustrates the electrically conductive tape member of the present invention fixedly adhered to the terminal end of the percutaneous needle electrode.
  • FIG. 6 is a partial cross-sectional view of the preferred embodiment of single- use connector for an embodiment of the present invention.
  • FIG. 7 is an electrical schematic for one embodiment of the single-use connector of FIG. 6.
  • FIG. 8 is an electrical schematic for another embodiment of the single-use connector of FIG. 6.
  • FIG. 9 illustrates another embodiment of a single use connector for an embodiment of the present invention.
  • FIG. 10 is an electrical schematic for one embodiment of the single-use connector of FIG. 9.
  • FIG. 11 illustrates another embodiment of a mechanical single use connector for an embodiment of the present invention.
  • FIG. 12 illustrates another embodiment of the lead wire set for use with the present invention utilizing a clip for electrically coupling the lead wire to the percutaneous needle electrode.
  • the electro-nerve stimulation apparatus 10 of the present invention comprises a pulse generator 12, a first electrically conductive, insulated lead wire 14, a second electrically conductive, insulated lead wire 16, an electrically conductive transcutaneous electrode 18 and an electrically conductive percutaneous needle electrode 20.
  • the first lead wire 14 has a first end 22 and a second end 24.
  • the first end 22 electrically couples to a first lead wire interface of the pulse generator 12.
  • the transcutaneous electrode 18 is preferably fixedly secured to the second end 24 of the first lead wire 14 as described in detail later.
  • the second lead wire 16 has a first end 30 and a second end 32.
  • the first end 30 of the second lead wire 16 electrically couples to a second lead wire interface of the pulse generator 12.
  • Fixedly secured to the second end 32 of the second lead wire is an electrically conductive adaptor.
  • the adaptor is preferably an electrically conductive tape member 38 as shown in FIG. 1.
  • the adaptor may be an electrically conductive clip 130 as illustrated in FIG. 12, for example.
  • the prefened electrically conductive tape member 38 includes an electrically conductive adhesive portion 40 and an electrically conductive non-adhesive portion 42 the purpose of which will be described in detail later.
  • first ends 22, 30 of the first and second lead wires 14, 16 are fixedly secured to a single male connector 44 which is matingly receivable by a single mating female receptacle 46.
  • the preferred single male connector 44 and single female receptacle 46 are also preferably keyed in any conventional manner to ensure that the first lead wire 14 will only electrically couple with the first lead wire interface and that the second lead wire 16 will only electrically couple with the second lead wire interface. This safeguard will ensure that the current pulses generated by the pulse generator 12 will flow from the transcutaneous electrode 18 to the percutaneous needle electrode 20 as describe in detail later. Referring now to FIG. 2, an exploded, cross-sectional view of the prefened transcutaneous electrode 18 is illustrated.
  • the prefened transcutaneous electrode 18 includes various layers sandwiched together, including a non-electrically conductive top layer 50, an intermediate electrically conductive foil 52, such as aluminum foil, and a bottom electrically conductive adhesive layer 54, preferably biocompatible and hypoallergenic, for adhering to the transcutaneous electrode 18 to the patient's skin as described later.
  • a removable backing strip 56 is preferably disposed over the lower face of the adhesive layer 54 which is then removed just prior to adhering the transcutaneous electrode 18 to the patient's skin.
  • Disposed between the lower face of the top layer 50 and the upper face of the electrically conductive layer 52 is another adhesive layer 58 which bonds the top non-conductive layer 50 to the intermediate conductive layer 54.
  • the second end 24 of the first lead wire 14 is disposed between the top non-conductive layer 50 and the intermediate conductive layer 52. A portion of the insulation is removed from the first lead wire 14 such that an electrical connection may be created with the electrically conductive layer 52.
  • the adhesive 58 preferably securely bonds the second end 24 of the first lead wire 14 to the conductive layer 52 to such that it cannot be readily removed therefrom without damaging the electrode 18.
  • the adhesive comprising the bottom adhesive layer 54 is preferably a single-use adhesive, meaning that the adhesive loses its adhesive properties upon its removal and will not readily re-adhere to the patient's skin, such that the transcutaneous electrode 18 is essentially non-reusable after one use. Referring now to FIG.
  • the tape member 38 also preferably includes various layers sandwiched together, including a non-electrically conductive top layer 70, an intermediate electrically conductive foil layer 72, such as aluminum foil, and a bottom electrically conductive adhesive layer 74 preferably extending over only a portion of the tape member 38 (see also FIG. 4). The remaining portion of the tape member 38 preferably does not include any adhesive.
  • a removable backing strip 76 is preferably disposed over the lower face of the bottom adhesive layer 74 which is then removed just prior to adhering the percutaneous needle electrode 20 thereto (discussed later).
  • Another adhesive layer 78 Disposed between the lower face of the top layer 70 and the upper face of the electrically conductive layer 72 is another adhesive layer 78 which bonds the top non-conductive layer 70 to the intermediate conductive layer 74.
  • the second end 32 of the second lead wire 16 is disposed between the top non-conductive layer 70 and the intermediate conductive layer 72. A portion of the insulation is removed from the second lead wire 16 such that an electrical connection may be created with the electrically conductive layer 72.
  • the adhesive 78 preferably securely bonds the second end 32 of the second lead wire 16 to the conductive layer 72 to such that it cannot be readily removed therefrom without damaging the tape member 38.
  • the tape member 38 is preferably adapted for only a single-use whereby the adhesive comprising the bottom adhesive layer 74 has sufficiently adhesive properties such that when the opposing ends of the tape member 38 are folded over onto each other and over the terminal end 92 of percutaneous needle electrode 20 (as discussed later) the ends of the tape member 38 cannot be readily unfolded thereby fixedly securing the percutaneous needle electrode 20 therebetween.
  • the percutaneous needle electrode 20 (FIG. 1) is preferably constructed out of medical grade stainless steel or other biocompatible electrically conductive metal.
  • The includes a first end 90 for insertion into the patient's body in proximity to the preselected internal stimulation site (discussed later) and a second end 92 to which the tape member 38 is to be electrically coupled.
  • the size of the needle electrode 20 is preferably small, for example 34G needle electrode (0.22 x 10 mm), to minimize trauma during insertion.
  • the second end 92 of the needle electrode 20 preferably includes an enlarged portion to enable the electrically conductive tape member 38 to be more easily adhered thereto (discussed later).
  • the pulse generator 12 is preferably a small handheld, battery operated pulse generator that produces small electrical current pulses, preferably between 1-10 mA, which pass between the transcutaneous electrode 18 and the percutaneous needle electrode 20.
  • the pulse generator 12 may be of the type disclosed in US Patent Application No. 09/213,558, which is incorporated herein by reference.
  • a commercially available cunent pulse generator manufactured by Finetech-Medical for the treatment of dropped foot has also been determined to be suitable for the present invention with minor modification to achieve the functionality and desired features of the present invention. Those skilled in the art would readily appreciate how to make such modifications of the Fintech-Medical pulse generator and therefore further discussion as to these modifications is not warranted.
  • the preferred pulse generator 12 includes a first dial 100 used for selecting the desired current pulse for treatment, preferably in increments of 1mA.
  • the preferred pulse generator 12 further includes a second dial 102 for setting the desired treatment time preferably in five minute increments.
  • the pulse generator 12 preferably generates an audible and/or visible signals. For example, a audible and/or visible signal may be initially generated when the pulse generator is turned on and when the dial 102 is turned past each of the predefined time increments. Additionally, an audible and/or visual signal maybe generated, for example, when one half of the remaining time selected for the treatment has expired. Also, when the time selected for the treatment expires, another audible and/or visual signal may be generated.
  • the desired internal stimulation site 104 on the patient's body 106 is determined depending on the treatment for which the electro- nerve stimulation system is to be used.
  • the first end 90 of the percutaneous needle electrode 18 is positioned to penetrate the patient's skin and is advanced into proximity with the preselected internal stimulation site.
  • the adhesive backing 56 on the transcutaneous electrode 18 is removed and the adhesive face 54 of the transcutaneous electrode 18 is pressed onto the surface of the patient's skin at the desired location, preferably distally (i.e., downstream) of the internal stimulation site .
  • the adhesive backing 76 on the electrically conductive tape member 38 is removed and the terminal end of the percutaneous needle electrode 20 (i.e.
  • the percutaneous needle electrode 20 is then preferably fixedly adhered to the tape member as shown in FIG. 5 by folding the ends of the tape member 38 over the terminal end 92 of the needle electrode 20.
  • the first and second lead wires 14, 16 are then electrically coupled to the pulse generator 12 by inserting the male connector 44 into the mating female receptacle 46.
  • the pulse generator 12 is activated to generate current pulses.
  • the cunent pulses from the pulse generator 12 traverse the internal stimulation site 104 by passing from the transcutaneous electrode 18 to the percutaneous needle electrode 20 as indicated by the arrow 108.
  • the electrically conductive tape member 38 includes a non-adhesive portion 42.
  • the user will be able to test whether the needle electrode 20 is properly positioned in proximity to the preselected internal stimulation site 104 to achieve the desired treatment results. If the needle electrode 20 is not properly positioned, the tape member 38 can simply be removed and the electrode needle repositioned or manipulated into the proper position.
  • the connector 44 may also be adapted to fail after a single use or after a predetermined time period.
  • FIGs. 6-8 illustrate possible embodiments for the connector 44 adapted for a single use.
  • the connector 44 may include two ports A and B conesponding to the first and second lead wires 14, 16 (also designated by conesponding reference letters A and B).
  • a third port C may include a fuse 120 which may be adapted to burn out after a preselected time period, thereby rendering the connector 44 incapable of making an electrical connection between the first and second lead wires 14, 16 with the lead wire interfaces of the pulse generator 12.
  • the connector 44 may include a serial read/write non- volatile erasable, programmable read only memory (EPROM) chip 122 programmable to prevent the lead wires 14, 16 from making an electrical connection with the lead wire interfaces of the pulse generator 12 after a predetermined time period.
  • EPROM erasable, programmable read only memory
  • the connector 44 may incorporate both a serial read/write non-volatile EPROM 122 and a fuse 120 in which the EPROM 122 is programmable to burn out the fuse after a preselected time period or to generate a current spike to burn out the fuse after expiration of a preselected time period.
  • An illustrative electrical schematic is shown in FIG.
  • a mechanical mechanism may be employed in which a pin 128 is biased within port C.
  • the mechanism is actuated to release the biased pin 128.
  • the released pin 128 prevents the connector from being reinserted into the female receptacle 46 thereby preventing the first and second lead wires 14, 16 from electrically coupling with the first and second lead wire interfaces of the pulse generator 12.
  • the electrically conductive adaptor may comprise a clip 130 for connecting with the terminal end 92 of the percutaneous needle electrode 20.
  • the clip 130 may have a bridge member 132 movable between an open position and a closed position by depressing the plunger 134. As cunent pulses from the pulse generator 12 traverse the bridge member 132, the bridge member may burn out preventing its reuse , or alternatively, the bridge member may fixedly bond or weld to the terminal end 92 of the percutaneous needle electrode 20 preventing reuse of the electrode and clip 130.
  • This embodiment may also be used with one or more of the alternative connector 44 embodiments described above.
  • the clip need not be a single-use clip 130 as just described.
  • the first and second lead wires 14 may include intermediate lead wire connectors 136 so the entire lead wire set does not need replacing.
  • reference to single-use adhesives, single-use connectors, or single-use adaptors as used herein does not mean that these devices must be completely incapable of reuse.
  • single-use should be understood as meaning that the disclosed structure, or its equivalent, for performing the intended function is sufficiently degraded or destroyed so that the structure does not perform its intended function as efficiently or that the structure is sufficiently degraded or destroyed to discourage or at least make it difficult to re-use the structure for its intended function.
  • the apparatus and system 10 of the present invention is particularly suited for the treatment of urinary urge incontinence.
  • the percutaneous needle electrode 20 is inserted into the patient's skin in proximity to the tibial nerve cephalic to the medial malleolus.
  • the transcutaneous electrode is adhered to the patient's skin distal to the percutaneous needle electrode.
  • the nerve stimulation system of the present invention is effective not only for the treatment of urge incontinence, but can also be effective for both nerve and muscle stimulation to treat numerous other conditions including gastro-reflux, chronic pain, Parkinson's disease, multiple sclerosis and general joint and muscle rehabilitation.

Abstract

An electro-nerve stimulation apparatus includes a pulse generator (12), first and second electrically conductive, insulated lead wires (14, 16), an electrically conductive transcutaneous electrode (18) and electrically conductive percutaneous needle electrode (20). The lead wire set includes a single-use mechanism (44) adapted to effectively discourage reuse of the electrodes.

Description

ELECTRO-NERVE STIMULATOR SYSTEM AND METHODS
BACKGROUND OF THE INVENTION
Field of the Invention: The present invention relates generally to electro-nerve stimulation and more particularly to electro-nerve stimulation systems utilizing transcutaneous and percutaneous electrodes. Description of the Related Art:
An electro-nerve stimulation system is disclosed in U.S. Patent Application No. 09/213,558 comprising a pulse generator electrically coupled by lead wires to an electrically conductive transcutaneous electrode (i.e., an electrode which does not penetrate the surface of the skin) and an electrically conductive percutaneous needle electrode (i.e., an electrode which penetrates the surface of the skin). In use, the transcutaneous electrode is positioned distally proximate the stimulation site. The percutaneous electrode needle, is positioned to penetrate the patient's skin and is advanced into proximity with the stimulation site. In this configuration, electrical current pulses from the pulse generator traverse the internal stimulation site by passing from the transcutaneous electrode to the percutaneous needle. This type of electro-nerve stimulation system disclosed in the '558 application has been found to be effective for both nerve and muscle stimulation for treatment of numerous conditions, including urge incontinence, chronic pain, Parkinson's disease, multiple sclerosis and for general muscle and joint rehabilitation.
While the foregoing electro-nerve stimulation system as disclosed in the above referenced '558 application serves its intended purpose, non-medical professionals who use the system for self treatment and for treating others, may not readily appreciate the health risks associated with re-using the same electrodes that may have come in contact with another person's skin and bodily fluids. Accordingly, there is a need in the industry for an electro-nerve stimulation system which provides the features and advantages disclosed in the above referenced '558 application, but which is designed to effectively prevent the electrodes from being reused for a second treatment. To the accomplishment effectively preventing reuse of the electrodes, the retail cost of disposable electrodes and their associated lead wires must be relatively inexpensive so that any perceived benefit in attempting to reuse the disposable electrodes is outweighed by the difficulty in attempting to do so.
SUMMARY OF THE INVENTION The present invention is an electro-nerve stimulation system comprising a pulse generator electrically coupled by first and second electrically conductive insulated lead wires to an electrically conductive transcutaneous electrode and an electrically conductive percutaneous needle electrode, respectively. One end of each of the first and second electrically conductive, insulated lead wires are preferably fixedly secured to a single male keyed connector which is matingly receivable by a single female keyed receptacle on the pulse generator. The other end of the first lead wire is fixedly secured to the electrically conductive transcutaneous electrode. One face of the transcutaneous electrode includes an electrically conductive medical grade adhesive to removably adhere the electrode to the patient's skin near the desired stimulation site. Fixedly secured to the other end of the second lead wire is an electrically conductive adaptor. In the preferred embodiment the electrically conductive adaptor is a tape member. The electrically conductive tape member preferably includes an electrically conductive adhesive portion and a non-adhesive portion. The percutaneous needle electrode is preferably fixedly securable to the tape member by folding the adhesive portion of the tape member over the end of the percutaneous needle extending from the patient's skin.
In use, the transcutaneous electrode with the first lead wire secured thereto is positioned and adhered to the patient's skin distally proximate the stimulation site. The percutaneous needle electrode, which is not yet electrically connected to the electrically conductive tape member, is positioned to penetrate the patient's skin and is advanced into proximity with the stimulation site. The first ends of the lead wires are electrically connected to the pulse generator by inserting the preferred single male connector into the mating female receptacle of the pulse generator. The pulse generator is activated. The end of the percutaneous needle electrode projecting outwardly from the patient's skin is placed and held in contact with the non-adhesive portion of the electrically conductive tape. The position of the percutaneous needle electrode is manipulated as needed until it is determined that the percutaneous needle is at the desired location in proximity to the desired stimulation site. Once it is determined that the percutaneous needle electrode is properly positioned, the needle is preferably fixedly secured to the electrically conductive tape by folding the ends of the adhesive portion of the electrically conductive tape member over the projecting end of the needle electrode thereby forming an electrical connection therebetween. In this configuration, current pulses generated by the pulse generator traverse the internal stimulation site from the transcutaneous needle electrode to the percutaneous needle electrode.
The adhesive on the face of the transcutaneous electrode for adhering to the patient's skin is preferably a single-use adhesive in that it will lose its adhesive properties upon removal such that it will not readily re-adhere to the patient's skin, thereby effectively rendering the transcutaneous electrode to a single use. The electrically conductive tape member is also preferably adapted for only a single use in that once the ends of the adhesive portion of the tape member is folder over the end of the percutaneous needle electrode, the folded ends of the tape member cannot be readily reopened for removal of the percutaneous needle adhered therein without damaging the tape member. In addition, or alternatively, the preferred single male connector is adapted for only a single use. In one alternative embodiment, the connector includes a fuse which will burn out after a preselected time period, thereby rendering the connector incapable of making an electrically conductive connection with the lead wire interfaces of pulse generator. Alternatively, after expiration of the preselected time period, the pulse generator may generate a current spike to burn out the fuse. In yet another alternative embodiment, a serial read/write non-volatile EPROM chip may be incorporated into the connector which is programmable to prevent an electrical connection with the lead wire interface of the pulse generator after a predetermined time period. In yet another alternative embodiment, the connector may incorporate both a serial read/write non- volatile EPROM and a fuse in which the EPROM is programmable to burn out the fuse after a preselected time period or to generate a spike to burn out the fuse after expiration of a preselected time period.
In still another alternative embodiment the adaptor secured to the second end of the second lead wire may be a clip for connecting with the terminal end of the percutaneous needle electrode. To prevent reuse of the needle electrode and the lead wire set, the clip is preferably designed to fail after one use. For example, the clip may have a bridge member movable between an open position and a closed position by depressing the plunger. As current pulses from the pulse generator traverse the bridge member, the bridge member may burn out preventing its reuse, or alternatively, the bridge member may fixedly bond or weld to the terminal end of the percutaneous needle electrode preventing reuse of the electrode and clip. In the alternative, or in addition thereto, this embodiment may also be used with one or more of the alternative single-use connector embodiments described above. If a single-use connector is used, the clip need not be a single-use clip.
To the accomplishment of the above objectives, features and advantages, this invention may be embodied in the forms illustrated in the accompanying drawings, attention being called to the fact, however, that the drawings are illustrative only, and that changes may be made in the specific form illustrated and described within the scope of the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates the preferred embodiment of the electro-nerve stimulator system of the present invention. FIG. 2 is an exploded cross-sectional view of the prefened embodiment of the transcutaneous electrode of the present invention.
FIG. 3 is an exploded cross-sectional view of the prefened embodiment of the electrically conductive tape member of the present invention.
FIG. 4 illustrates the positioning of the terminal end of the percutaneous needle electrode onto the adhesive portion of the electrically conductive tape member of the present invention.
FIG. 5 illustrates the electrically conductive tape member of the present invention fixedly adhered to the terminal end of the percutaneous needle electrode.
FIG. 6 is a partial cross-sectional view of the preferred embodiment of single- use connector for an embodiment of the present invention.
FIG. 7 is an electrical schematic for one embodiment of the single-use connector of FIG. 6. FIG. 8 is an electrical schematic for another embodiment of the single-use connector of FIG. 6.
FIG. 9 illustrates another embodiment of a single use connector for an embodiment of the present invention. FIG. 10 is an electrical schematic for one embodiment of the single-use connector of FIG. 9.
FIG. 11 illustrates another embodiment of a mechanical single use connector for an embodiment of the present invention.
FIG. 12 illustrates another embodiment of the lead wire set for use with the present invention utilizing a clip for electrically coupling the lead wire to the percutaneous needle electrode.
DETAILED DESCRIPTION OF THE INVENTION The electro-nerve stimulation apparatus 10 of the present invention, as illustrated in FIG. 1, comprises a pulse generator 12, a first electrically conductive, insulated lead wire 14, a second electrically conductive, insulated lead wire 16, an electrically conductive transcutaneous electrode 18 and an electrically conductive percutaneous needle electrode 20.
In the preferred embodiment of the apparatus 10, the first lead wire 14 has a first end 22 and a second end 24. The first end 22 electrically couples to a first lead wire interface of the pulse generator 12. The transcutaneous electrode 18 is preferably fixedly secured to the second end 24 of the first lead wire 14 as described in detail later.
The second lead wire 16 has a first end 30 and a second end 32. The first end 30 of the second lead wire 16 electrically couples to a second lead wire interface of the pulse generator 12. Fixedly secured to the second end 32 of the second lead wire is an electrically conductive adaptor. The adaptor is preferably an electrically conductive tape member 38 as shown in FIG. 1. In an alternative embodiment, the adaptor may be an electrically conductive clip 130 as illustrated in FIG. 12, for example. The prefened electrically conductive tape member 38 includes an electrically conductive adhesive portion 40 and an electrically conductive non-adhesive portion 42 the purpose of which will be described in detail later. In the preferred embodiment, the first ends 22, 30 of the first and second lead wires 14, 16 are fixedly secured to a single male connector 44 which is matingly receivable by a single mating female receptacle 46. The preferred single male connector 44 and single female receptacle 46 are also preferably keyed in any conventional manner to ensure that the first lead wire 14 will only electrically couple with the first lead wire interface and that the second lead wire 16 will only electrically couple with the second lead wire interface. This safeguard will ensure that the current pulses generated by the pulse generator 12 will flow from the transcutaneous electrode 18 to the percutaneous needle electrode 20 as describe in detail later. Referring now to FIG. 2, an exploded, cross-sectional view of the prefened transcutaneous electrode 18 is illustrated. The prefened transcutaneous electrode 18 includes various layers sandwiched together, including a non-electrically conductive top layer 50, an intermediate electrically conductive foil 52, such as aluminum foil, and a bottom electrically conductive adhesive layer 54, preferably biocompatible and hypoallergenic, for adhering to the transcutaneous electrode 18 to the patient's skin as described later. A removable backing strip 56 is preferably disposed over the lower face of the adhesive layer 54 which is then removed just prior to adhering the transcutaneous electrode 18 to the patient's skin. Disposed between the lower face of the top layer 50 and the upper face of the electrically conductive layer 52 is another adhesive layer 58 which bonds the top non-conductive layer 50 to the intermediate conductive layer 54. The second end 24 of the first lead wire 14 is disposed between the top non-conductive layer 50 and the intermediate conductive layer 52. A portion of the insulation is removed from the first lead wire 14 such that an electrical connection may be created with the electrically conductive layer 52. The adhesive 58 preferably securely bonds the second end 24 of the first lead wire 14 to the conductive layer 52 to such that it cannot be readily removed therefrom without damaging the electrode 18. In the preferred embodiment, the adhesive comprising the bottom adhesive layer 54 is preferably a single-use adhesive, meaning that the adhesive loses its adhesive properties upon its removal and will not readily re-adhere to the patient's skin, such that the transcutaneous electrode 18 is essentially non-reusable after one use. Referring now to FIG. 3, an exploded, cross-sectional view of the preferred electrically conductive tape member 38 is illustrated. The tape member 38 also preferably includes various layers sandwiched together, including a non-electrically conductive top layer 70, an intermediate electrically conductive foil layer 72, such as aluminum foil, and a bottom electrically conductive adhesive layer 74 preferably extending over only a portion of the tape member 38 (see also FIG. 4). The remaining portion of the tape member 38 preferably does not include any adhesive. A removable backing strip 76 is preferably disposed over the lower face of the bottom adhesive layer 74 which is then removed just prior to adhering the percutaneous needle electrode 20 thereto (discussed later). Disposed between the lower face of the top layer 70 and the upper face of the electrically conductive layer 72 is another adhesive layer 78 which bonds the top non-conductive layer 70 to the intermediate conductive layer 74. The second end 32 of the second lead wire 16 is disposed between the top non-conductive layer 70 and the intermediate conductive layer 72. A portion of the insulation is removed from the second lead wire 16 such that an electrical connection may be created with the electrically conductive layer 72. The adhesive 78 preferably securely bonds the second end 32 of the second lead wire 16 to the conductive layer 72 to such that it cannot be readily removed therefrom without damaging the tape member 38. In the preferred embodiment, the tape member 38 is preferably adapted for only a single-use whereby the adhesive comprising the bottom adhesive layer 74 has sufficiently adhesive properties such that when the opposing ends of the tape member 38 are folded over onto each other and over the terminal end 92 of percutaneous needle electrode 20 (as discussed later) the ends of the tape member 38 cannot be readily unfolded thereby fixedly securing the percutaneous needle electrode 20 therebetween.
The percutaneous needle electrode 20 (FIG. 1) is preferably constructed out of medical grade stainless steel or other biocompatible electrically conductive metal. The includes a first end 90 for insertion into the patient's body in proximity to the preselected internal stimulation site (discussed later) and a second end 92 to which the tape member 38 is to be electrically coupled. The size of the needle electrode 20 is preferably small, for example 34G needle electrode (0.22 x 10 mm), to minimize trauma during insertion. The second end 92 of the needle electrode 20 preferably includes an enlarged portion to enable the electrically conductive tape member 38 to be more easily adhered thereto (discussed later).
Referring again to FIG. 1, the pulse generator 12 is preferably a small handheld, battery operated pulse generator that produces small electrical current pulses, preferably between 1-10 mA, which pass between the transcutaneous electrode 18 and the percutaneous needle electrode 20. The pulse generator 12 may be of the type disclosed in US Patent Application No. 09/213,558, which is incorporated herein by reference. A commercially available cunent pulse generator manufactured by Finetech-Medical for the treatment of dropped foot has also been determined to be suitable for the present invention with minor modification to achieve the functionality and desired features of the present invention. Those skilled in the art would readily appreciate how to make such modifications of the Fintech-Medical pulse generator and therefore further discussion as to these modifications is not warranted. The preferred pulse generator 12 includes a first dial 100 used for selecting the desired current pulse for treatment, preferably in increments of 1mA. The preferred pulse generator 12 further includes a second dial 102 for setting the desired treatment time preferably in five minute increments. The pulse generator 12 preferably generates an audible and/or visible signals. For example, a audible and/or visible signal may be initially generated when the pulse generator is turned on and when the dial 102 is turned past each of the predefined time increments. Additionally, an audible and/or visual signal maybe generated, for example, when one half of the remaining time selected for the treatment has expired. Also, when the time selected for the treatment expires, another audible and/or visual signal may be generated.
As illustrated in FIG. 1, in use, the desired internal stimulation site 104 on the patient's body 106 is determined depending on the treatment for which the electro- nerve stimulation system is to be used. The first end 90 of the percutaneous needle electrode 18 is positioned to penetrate the patient's skin and is advanced into proximity with the preselected internal stimulation site. The adhesive backing 56 on the transcutaneous electrode 18 is removed and the adhesive face 54 of the transcutaneous electrode 18 is pressed onto the surface of the patient's skin at the desired location, preferably distally (i.e., downstream) of the internal stimulation site . The adhesive backing 76 on the electrically conductive tape member 38 is removed and the terminal end of the percutaneous needle electrode 20 (i.e. the end extending from the patient's body) is positioned at approximately the midpoint of the tape member 38 as illustrated in FIG. 4. The percutaneous needle electrode 20 is then preferably fixedly adhered to the tape member as shown in FIG. 5 by folding the ends of the tape member 38 over the terminal end 92 of the needle electrode 20. The first and second lead wires 14, 16 are then electrically coupled to the pulse generator 12 by inserting the male connector 44 into the mating female receptacle 46. The pulse generator 12 is activated to generate current pulses. The cunent pulses from the pulse generator 12 traverse the internal stimulation site 104 by passing from the transcutaneous electrode 18 to the percutaneous needle electrode 20 as indicated by the arrow 108.
It may be desirable to test whether the percutaneous needle electrode 20 is properly positioned in proximity to the internal stimulation site 104 prior to fixedly adhering the electrode 20 to the tape member 38. Accordingly, in the preferred embodiment the electrically conductive tape member 38 includes a non-adhesive portion 42. By holding the needle electrode 20 against the non-adhesive portion 42 of the electrically conductive tape member 38 while the pulse generator is activated, the user will be able to test whether the needle electrode 20 is properly positioned in proximity to the preselected internal stimulation site 104 to achieve the desired treatment results. If the needle electrode 20 is not properly positioned, the tape member 38 can simply be removed and the electrode needle repositioned or manipulated into the proper position.
In order to further ensure that the electrodes 18, 20 and associated lead wires 14, 16 are not readily re-usable after coming into contact with a patient's skin or bodily fluids, the connector 44 may also be adapted to fail after a single use or after a predetermined time period. FIGs. 6-8 illustrate possible embodiments for the connector 44 adapted for a single use. The connector 44 may include two ports A and B conesponding to the first and second lead wires 14, 16 (also designated by conesponding reference letters A and B). A third port C may include a fuse 120 which may be adapted to burn out after a preselected time period, thereby rendering the connector 44 incapable of making an electrical connection between the first and second lead wires 14, 16 with the lead wire interfaces of the pulse generator 12. Alternatively, as illustrated in FIG. 8, the connector 44 may include a serial read/write non- volatile erasable, programmable read only memory (EPROM) chip 122 programmable to prevent the lead wires 14, 16 from making an electrical connection with the lead wire interfaces of the pulse generator 12 after a predetermined time period. In yet another embodiment, as shown in FIGs 9-10, the connector 44 may incorporate both a serial read/write non-volatile EPROM 122 and a fuse 120 in which the EPROM 122 is programmable to burn out the fuse after a preselected time period or to generate a current spike to burn out the fuse after expiration of a preselected time period. An illustrative electrical schematic is shown in FIG. 10 for this embodiment which may include a resister 124 and a zenor diode 126. In yet another alternative embodiment as shown in FIG. 11, a mechanical mechanism may be employed in which a pin 128 is biased within port C. In operation, upon insertion of the connector 44 into the female receptacle 46 of the pulse generator 12 the mechanism is actuated to release the biased pin 128. Upon removal of the connector 44 from the female receptacle 46, the released pin 128 prevents the connector from being reinserted into the female receptacle 46 thereby preventing the first and second lead wires 14, 16 from electrically coupling with the first and second lead wire interfaces of the pulse generator 12.
In still another alternative embodiment as illustrated in FIG. 12, the electrically conductive adaptor may comprise a clip 130 for connecting with the terminal end 92 of the percutaneous needle electrode 20. The clip 130 may have a bridge member 132 movable between an open position and a closed position by depressing the plunger 134. As cunent pulses from the pulse generator 12 traverse the bridge member 132, the bridge member may burn out preventing its reuse , or alternatively, the bridge member may fixedly bond or weld to the terminal end 92 of the percutaneous needle electrode 20 preventing reuse of the electrode and clip 130. This embodiment may also be used with one or more of the alternative connector 44 embodiments described above. If a single-use connector 44 as identified above is used with the clip 130, the clip need not be a single-use clip 130 as just described. Also as shown in FIG. 12, the first and second lead wires 14 may include intermediate lead wire connectors 136 so the entire lead wire set does not need replacing. Naturally, it is not possible to design a system which is completely capable of preventing a determined individual from refurbishing the lead wires and or electrodes so that they may be reused. Thus, reference to single-use adhesives, single-use connectors, or single-use adaptors as used herein does not mean that these devices must be completely incapable of reuse. Rather as used herein, the term "single-use" should be understood as meaning that the disclosed structure, or its equivalent, for performing the intended function is sufficiently degraded or destroyed so that the structure does not perform its intended function as efficiently or that the structure is sufficiently degraded or destroyed to discourage or at least make it difficult to re-use the structure for its intended function.
The apparatus and system 10 of the present invention is particularly suited for the treatment of urinary urge incontinence. The percutaneous needle electrode 20 is inserted into the patient's skin in proximity to the tibial nerve cephalic to the medial malleolus. The transcutaneous electrode is adhered to the patient's skin distal to the percutaneous needle electrode. Those skilled in the art will appreciate that the nerve stimulation system of the present invention is effective not only for the treatment of urge incontinence, but can also be effective for both nerve and muscle stimulation to treat numerous other conditions including gastro-reflux, chronic pain, Parkinson's disease, multiple sclerosis and general joint and muscle rehabilitation. Although only certain exemplary embodiments of the invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the following claims.

Claims

1. An electro-nerve stimulation apparatus, comprising: a pulse generator for generating electrical pulses, said pulse generator having a first lead interface and a second lead interface; a first electrically conductive, insulated lead wire having first and second ends, said first end of said first lead wire fixedly secured to a first connector for electrically coupling with said first lead wire interface of said pulse generator, said second end of said first lead wire operably secured to an electrically conductive transcutaneous electrode for delivering electrical pulses generated by the pulse generator to a patient's skin; a second electrically conductive, insulated lead wire having first and second ends, said first end of said second lead wire fixedly secured to a second connector for electrically coupling with said second lead wire interface of said pulse generator, said second end of said second lead wire fixedly secured to an electrically conductive adaptor for electrically connecting with a terminal end of a percutaneous needle electrode, said electrically conductive percutaneous needle electrode having another end insertable into a patient's body in proximity to an internal stimulation site to receive electrical pulses from said transcutaneous electrode; a single-use mechanism comprising a part of at least one of said lead wire sets to effectively discourage re-use of the percutaneous and transcutaneous electrodes.
2. The apparatus of claim 1, wherein said electrically conductive transcutaneous electrode includes adhesive on a face thereof for removably securing said transcutaneous electrode onto said patient's body at a desired location.
3. The apparatus of claim 2, wherein said adhesive on said face of said transcutaneous electrode is a single-use adhesive such that upon removal of said transcutaneous electrode from said patient's skin said adhesive will not readily re-adhere to said patient's skin.
4. The apparatus of claim 1 wherein said electrically conductive adaptor includes an electrically conductive tape member having an adhesive portion.
5. The apparatus of claim 4 wherein said terminal end of said percutaneous needle electrode is fixedly adhered to said adhesive portion of said electrically conductive tape member, whereby said percutaneous needle electrode is not readily removable therefrom without damaging said tape member.
6. The apparatus of claim 5, wherein said electrically conductive tape member further includes a non-adhesive electrically conductive portion for testing proper placement of said other end of said percutaneous needle electrode in proximity to said internal stimulation site prior to adhering said terminal end of said percutaneous needle electrode to said adhesive portion of said electrically conductive tape member.
7. The apparatus of claim 1, wherein said first and second connectors fixedly secured to said first ends of said first and second lead wires comprise a single male connector and wherein said pulse generator includes a single mating female receptacle for electrically coupling said first and second lead wires with said first and second lead wire interfaces, and wherein said male connectors and said female receptacles are keyed to ensure proper orientation and electrical coupling of said first and second lead wires with the respective first and second lead interfaces of said pulse generator.
8. The apparatus of claim 7, wherein said single male connector is a single-use connector whereby said single male connector is not readily reusable.
9. The apparatus of claim 8 wherein said single use connector includes a fuse adapted to burn out after a preselected time period.
10. The apparatus of claim 8 wherein said single use connector includes an EPROM programmed to prevent electrical connection of said first and second lead wires with said first and second lead wire interfaces.
11. The apparatus of claim 8 wherein said single use connector includes a fuse and an EPROM programmed to burn out said fuse after a predetermined time period.
12. The apparatus of claim 8 wherein said single use connector includes a fuse and an EPROM programmed to generate a cunent spike to burn out said fuse after a predetermined time period.
13. The apparatus of claim 1 wherein said electrically conductive adaptor includes a clip having an electrically conductive bridge member movable between a first open position and a second closed position.
14. The apparatus of claim 13 wherein said terminal end of said percutaneous needle electrode is secured to said electrically conductive bridge member.
15. The apparatus of claim 14 wherein said clip is a single-use clip.
16. The apparatus of claim 15 wherein said bridge member fails after a predetermined time period of cunent pulses traverse therethrough.
17. The apparatus of claim 15 wherein said bridge member welds to said terminal end of said percutaneous needle electrode after a predetermined time period of cunent pulses traverse therethrough.
18. The apparatus of claim 13, wherein said first and second connectors fixedly secured to said first ends of said first and second lead wires comprise a single male connector and wherein said pulse generator includes a single mating female receptacle for electrically coupling said first and second lead wires with said first and second lead wire interfaces, and further wherein said single male connector and said mating single female receptacle are keyed to ensure proper orientation and electrical coupling of said first and second lead wires only with the respective first and second lead interfaces of said pulse generator.
19. The apparatus of claim 18, wherein said single male connector is a single-use connector whereby said single male connector is not readily reusable.
20. The apparatus of claim 19 wherein said single use connector includes a fuse adapted to burn out after a preselected time period.
21. The apparatus of claim 19 wherein said single use connector includes an EPROM programmed to prevent electrical connection of said first and second lead wires with said first and second lead wire interfaces.
22. The apparatus of claim 19 wherein said single use connector includes a fuse and an EPROM programmed to burn out said fuse after a predetermined time period.
23. The apparatus of claim 19 wherein said single use connector includes a fuse and an EPROM programmed to generate a cunent spike to bum out said fuse after a predetermined time period.
24. A method for electro-nerve stimulation, comprising the steps of:
(a) providing a pulse generator for generating electrical pulses, said pulse generator having a first lead interface and a second lead interface;
(b) providing a first electrically conductive, insulated lead wire having first and second ends, said first end of said first lead wire fixedly secured to a connector for electrically coupling with said first lead wire interface of said pulse generator, said second end of said first lead wire operably secured to an electrically conductive transcutaneous electrode for delivering electrical pulses generated by said pulse generator to a patient's skin;
(c) providing an electrically conductive percutaneous needle electrode, said electrically conductive percutaneous needle electrode having one end insertable into a patient's body in proximity to a preselected internal stimulation site to receive electrical pulses from said transcutaneous electrode;
(d) providing a second electrically conductive, insulated lead wire having first and second ends, said first end of said second lead wire fixedly secured to a connector for electrically coupling with said second lead wire interface of said pulse generator, said second end of said second lead wire fixedly secured to an electrically conductive adaptor; (e) providing a single-use mechanism comprising a part of at least one of said lead wire sets to effectively discourage re-use of said percutaneous and transcutaneous electrodes;
(f) penetrating said patient's skin with said one end of said percutaneous needle electrode and advancing said one end into proximity with said preselected internal stimulation site;
(g) electrically connecting a terminal end of said percutaneous needle electrode to said electrically conductive single-use adaptor;
(h) adhering said transcutaneous electrode onto said patient's skin distal to said preselected internal stimulation site;
(i) electrically coupling said first and second lead wires with said respective first and second lead wire interfaces of said pulse generator;
(j) activating said pulse generator to generate electrical pulses that traverse the preselected internal stimulation site between said transcutaneous electrode and said percutaneous needle electrode.
25. The method of claim 24, wherein said electrically conductive transcutaneous electrode includes adhesive on a face thereof for removably securing said electrode onto said skin of said patient.
26. The method of claim 25, wherein said adhesive on said face of said transcutaneous electrode is a single-use adhesive such that upon removal of said transcutaneous electrode from said patient's skin said adhesive will not readily re-adhere to said patient's skin.
27. The method of claim 24 wherein said electrically conductive adaptor includes an electrically conductive tape member having an adhesive portion.
28. The method of claim 27 wherein said step of connecting said terminal end of said percutaneous needle electrode to said adaptor includes the step of fixedly adhering said adhesive portion of said electrically conductive tape member to said terminal end, whereby said percutaneous needle electrode is not readily removable therefrom without damaging said tape member.
29. The method of claim 28, further including the step of testing proper placement of said one end of said percutaneous needle electrode in proximity to said preselected internal stimulation site prior to fixedly adhering said terminal end of said percutaneous needle electrode to said adhesive portion of said electrically conductive tape member by contacting said other end of said percutaneous needle with a non-adhesive electrically conductive portion of said electrically conductive tape member.
30. The method of claim 24, wherein said first and second connectors fixedly secured to said first ends of said first and second lead wires comprise a single male connector and wherein said pulse generator includes a single mating female receptacle for electrically coupling said first and second lead wires with said first and second lead wire interfaces, and further wherein said single male connector and said mating single female receptacle are keyed to ensure proper orientation and electrical coupling of said first and second lead wires only with the respective first and second lead interfaces of said pulse generator.
31. The method of claim 30, wherein said single male connector is a single-use connector whereby said single male connector is not readily reusable.
32. The method of claim 31 wherein said single use connector includes a fuse adapted to bum out after a preselected time period.
33. The method of claim 31 wherein said single use connector includes an EPROM programmed to prevent electrical connection of said first and second lead wires with said first and second lead wire interfaces.
34. The method of claim 31 wherein said single use connector includes a fuse and an EPROM programmed to bum out said fuse after a predetermined time period.
35. The method of claim 31 wherein said single use connector includes a fuse and an EPROM programmed to generate a cunent spike to bum out said fuse after a predetermined time period.
36. The method of claim 24 wherein said electrically conductive adaptor includes a clip having an electrically conductive bridge member movable between a first open position and a second closed position.
37. The method of claim 36 wherein said step of connecting said terminal end of said percutaneous needle electrode to said adaptor includes the step of connecting said terminal end of said percutaneous needle electrode to said electrically conductive bridge member.
38. The method of claim 37 wherein said clip is a single-use clip.
39. The method of claim 38 wherein said bridge member fails after a predetermined time period of cunent pulses traverse therethrough.
40. The method of claim 38 wherein said bridge member welds to said terminal end of said percutaneous needle electrode after a predetermined time period of cunent pulses traverse therethrough.
41. The method of claim 36, wherein said first and second connectors fixedly secured to said first ends of said first and second lead wires comprise a single male connector and wherein said pulse generator includes a single mating female receptacle for electrically coupling said first and second lead wires with said first and second lead wire interfaces, and further wherein said single male connector and said mating single female receptacle are keyed to ensure proper orientation and electrical coupling of said first and second lead wires only with the respective first and second lead interfaces of said pulse generator.
42. The method of claim 41, wherein said single male connector is a single-use connector whereby said single male connector is not readily reusable.
43. The method of claim 42 wherein said single use connector includes a fuse adapted to bum out after a preselected time period.
44. The method of claim 42 wherein said single use connector includes an EPROM programmed to prevent electrical connection of said first and second lead wires with said first and second lead wire interfaces.
45. The method of claim 42 wherein said single use connector includes a fuse and an EPROM programmed to bum out said fuse after a predetermined time period.
PCT/US2002/033318 2001-10-18 2002-10-18 Electro-nerve stimulator system and methods WO2003033068A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
CA2463936A CA2463936C (en) 2001-10-18 2002-10-18 Electro-nerve stimulator system and methods
AT02786437T ATE536907T1 (en) 2001-10-18 2002-10-18 ELECTRICAL NERVOUS STIMULATION SYSTEM AND METHOD
EP02786437A EP1444004B1 (en) 2001-10-18 2002-10-18 Electro-nerve stimulator system and methods
AU2002349957A AU2002349957A1 (en) 2001-10-18 2002-10-18 Electro-nerve stimulator system and methods
DK02786437.0T DK1444004T3 (en) 2001-10-18 2002-10-18 Electrical nerve stimulation system and methods
US10/492,578 US7536226B2 (en) 2001-10-18 2002-10-18 Electro-nerve stimulator system and methods
ES02786437T ES2377946T3 (en) 2001-10-18 2002-10-18 Electrical neurostimulation system and procedures
US11/804,200 US8812114B2 (en) 2001-10-18 2007-05-17 Lead set for nerve stimulator and method of operation thereof
US14/322,525 US9056194B2 (en) 2001-10-18 2014-07-02 Lead set for nerve stimulator and method of operation thereof
US14/682,564 US9265941B2 (en) 2001-10-18 2015-04-09 Lead set for nerve stimulator and method of operation thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US33607401P 2001-10-18 2001-10-18
US60/336,074 2001-10-18

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US10492578 A-371-Of-International 2002-10-18
US10/492,578 A-371-Of-International US7536226B2 (en) 2001-10-18 2002-10-18 Electro-nerve stimulator system and methods
US11/804,200 Continuation-In-Part US8812114B2 (en) 2001-10-18 2007-05-17 Lead set for nerve stimulator and method of operation thereof

Publications (2)

Publication Number Publication Date
WO2003033068A2 true WO2003033068A2 (en) 2003-04-24
WO2003033068A3 WO2003033068A3 (en) 2004-03-11

Family

ID=23314453

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/033318 WO2003033068A2 (en) 2001-10-18 2002-10-18 Electro-nerve stimulator system and methods

Country Status (9)

Country Link
US (1) US7536226B2 (en)
EP (2) EP1444004B1 (en)
AT (1) ATE536907T1 (en)
AU (1) AU2002349957A1 (en)
CA (1) CA2463936C (en)
DK (2) DK2308553T3 (en)
ES (2) ES2450465T3 (en)
PT (2) PT1444004E (en)
WO (1) WO2003033068A2 (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006098823A1 (en) * 2005-03-11 2006-09-21 Medtronic, Inc. Neurostimulation site screening
US7555345B2 (en) 2005-03-11 2009-06-30 Medtronic, Inc. Implantable neurostimulator device
US7668598B2 (en) 2006-05-18 2010-02-23 Uroplasty, Inc. Method and apparatus for stimulating a nerve of a patient
US7729772B2 (en) 2005-01-07 2010-06-01 Uroplasty, Inc. Implantable neuromodulation system and method
WO2012000003A1 (en) 2010-06-30 2012-01-05 Biegler Gmbh Electrical stimulation device
US20140073985A1 (en) * 2005-03-01 2014-03-13 Checkpoint Surgical, Llc Stimulation device adapter
US8812114B2 (en) 2001-10-18 2014-08-19 Uroplasty, Inc. Lead set for nerve stimulator and method of operation thereof
US9008782B2 (en) 2007-10-26 2015-04-14 Medtronic, Inc. Occipital nerve stimulation

Families Citing this family (66)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7810359B2 (en) 2002-10-01 2010-10-12 Nellcor Puritan Bennett Llc Headband with tension indicator
US7047056B2 (en) 2003-06-25 2006-05-16 Nellcor Puritan Bennett Incorporated Hat-based oximeter sensor
US8412297B2 (en) 2003-10-01 2013-04-02 Covidien Lp Forehead sensor placement
CA2553901C (en) 2004-01-22 2015-01-20 Rehabtronics Inc. Method of routing electrical current to bodily tissues via implanted passive conductors
US20100016929A1 (en) * 2004-01-22 2010-01-21 Arthur Prochazka Method and system for controlled nerve ablation
US7212865B2 (en) * 2004-05-25 2007-05-01 Philip Cory Nerve stimulator and method
CA2608397A1 (en) * 2005-06-28 2007-01-04 Bioness Development, Llc Improvements to an implant, system and method using implanted passive conductors for routing electrical current
US20070167990A1 (en) * 2006-01-17 2007-07-19 Theranova, Llc Method and apparatus for low frequency induction therapy for the treatment of urinary incontinence and overactive bladder
US9610459B2 (en) 2009-07-24 2017-04-04 Emkinetics, Inc. Cooling systems and methods for conductive coils
US9339641B2 (en) 2006-01-17 2016-05-17 Emkinetics, Inc. Method and apparatus for transdermal stimulation over the palmar and plantar surfaces
EP2024017A4 (en) * 2006-05-18 2010-01-13 Uroplasty Inc Lead set for nerve stimulator and method of operation thereof
JP2010505471A (en) 2006-10-02 2010-02-25 エムキネティクス， インコーポレイテッド Method and apparatus for magnetic induction therapy
US9005102B2 (en) 2006-10-02 2015-04-14 Emkinetics, Inc. Method and apparatus for electrical stimulation therapy
US10786669B2 (en) 2006-10-02 2020-09-29 Emkinetics, Inc. Method and apparatus for transdermal stimulation over the palmar and plantar surfaces
US11224742B2 (en) 2006-10-02 2022-01-18 Emkinetics, Inc. Methods and devices for performing electrical stimulation to treat various conditions
US8483820B2 (en) * 2006-10-05 2013-07-09 Bioness Inc. System and method for percutaneous delivery of electrical stimulation to a target body tissue
US8374673B2 (en) 2007-01-25 2013-02-12 Warsaw Orthopedic, Inc. Integrated surgical navigational and neuromonitoring system having automated surgical assistance and control
US7987001B2 (en) 2007-01-25 2011-07-26 Warsaw Orthopedic, Inc. Surgical navigational and neuromonitoring instrument
US9757554B2 (en) 2007-08-23 2017-09-12 Bioness Inc. System for transmitting electrical current to a bodily tissue
US8738137B2 (en) 2007-08-23 2014-05-27 Bioness Inc. System for transmitting electrical current to a bodily tissue
CA2697381A1 (en) * 2007-08-23 2009-02-26 Bioness, Inc. System for transmitting electrical current to a bodily tissue
US20090326602A1 (en) 2008-06-27 2009-12-31 Arkady Glukhovsky Treatment of indications using electrical stimulation
US8463383B2 (en) * 2008-08-01 2013-06-11 Ndi Medical, Inc. Portable assemblies, systems, and methods for providing functional or therapeutic neurostimulation
US8364220B2 (en) 2008-09-25 2013-01-29 Covidien Lp Medical sensor and technique for using the same
US8257274B2 (en) 2008-09-25 2012-09-04 Nellcor Puritan Bennett Llc Medical sensor and technique for using the same
US8515515B2 (en) 2009-03-25 2013-08-20 Covidien Lp Medical sensor with compressible light barrier and technique for using the same
US9486628B2 (en) 2009-03-31 2016-11-08 Inspire Medical Systems, Inc. Percutaneous access for systems and methods of treating sleep apnea
US8781548B2 (en) 2009-03-31 2014-07-15 Covidien Lp Medical sensor with flexible components and technique for using the same
AU2010275413A1 (en) 2009-07-23 2012-02-09 Emkinetics, Inc. Method and apparatus for magnetic induction therapy
AU2010313487A1 (en) 2009-10-26 2012-05-24 Emkinetics, Inc. Method and apparatus for electromagnetic stimulation of nerve, muscle, and body tissues
US8588884B2 (en) 2010-05-28 2013-11-19 Emkinetics, Inc. Microneedle electrode
US8788045B2 (en) 2010-06-08 2014-07-22 Bluewind Medical Ltd. Tibial nerve stimulation
US9457186B2 (en) 2010-11-15 2016-10-04 Bluewind Medical Ltd. Bilateral feedback
US9186504B2 (en) 2010-11-15 2015-11-17 Rainbow Medical Ltd Sleep apnea treatment
CA2839532A1 (en) 2011-06-16 2012-12-20 Advanced Uro-Solutions, Llc Percutaneous tibial nerve stimulator
US9076187B1 (en) 2011-06-16 2015-07-07 Advanced Uro-Solutions, Llc Medical device payment system
AU2012334926B2 (en) 2011-11-11 2017-07-13 The Regents Of The University Of California Transcutaneous spinal cord stimulation: noninvasive tool for activation of locomotor circuitry
WO2013111137A2 (en) 2012-01-26 2013-08-01 Rainbow Medical Ltd. Wireless neurqstimulatqrs
DE102012010262B4 (en) 2012-05-25 2014-07-03 Albrecht Molsberger Therapeutically applicable DC delivery device
WO2014087337A1 (en) 2012-12-06 2014-06-12 Bluewind Medical Ltd. Delivery of implantable neurostimulators
US9993642B2 (en) 2013-03-15 2018-06-12 The Regents Of The University Of California Multi-site transcutaneous electrical stimulation of the spinal cord for facilitation of locomotion
US10137299B2 (en) 2013-09-27 2018-11-27 The Regents Of The University Of California Engaging the cervical spinal cord circuitry to re-enable volitional control of hand function in tetraplegic subjects
ES2546651B1 (en) * 2014-03-24 2016-11-16 Ionclinics And Deionic, S.L. Device for the recovery of tendinopathies and fibrillar tears
WO2016028608A1 (en) 2014-08-17 2016-02-25 Nine Continents Medical, Inc. Miniature implatable neurostimulator system for sciatic nerves and their branches
US10751533B2 (en) 2014-08-21 2020-08-25 The Regents Of The University Of California Regulation of autonomic control of bladder voiding after a complete spinal cord injury
CA2959378A1 (en) 2014-08-27 2016-03-03 The Regents Of The University Of California Multi-electrode array for spinal cord epidural stimulation
US10004896B2 (en) 2015-01-21 2018-06-26 Bluewind Medical Ltd. Anchors and implant devices
US9597521B2 (en) 2015-01-21 2017-03-21 Bluewind Medical Ltd. Transmitting coils for neurostimulation
US9764146B2 (en) 2015-01-21 2017-09-19 Bluewind Medical Ltd. Extracorporeal implant controllers
US9782589B2 (en) 2015-06-10 2017-10-10 Bluewind Medical Ltd. Implantable electrostimulator for improving blood flow
CN108136177A (en) * 2015-08-06 2018-06-08 加利福尼亚大学董事会 For carrying out electrod-array of transcutaneous electrostimulation and application thereof to spinal cord
US11298533B2 (en) 2015-08-26 2022-04-12 The Regents Of The University Of California Concerted use of noninvasive neuromodulation device with exoskeleton to enable voluntary movement and greater muscle activation when stepping in a chronically paralyzed subject
US11097122B2 (en) 2015-11-04 2021-08-24 The Regents Of The University Of California Magnetic stimulation of the spinal cord to restore control of bladder and/or bowel
US10105540B2 (en) 2015-11-09 2018-10-23 Bluewind Medical Ltd. Optimization of application of current
US9713707B2 (en) 2015-11-12 2017-07-25 Bluewind Medical Ltd. Inhibition of implant migration
US11344722B2 (en) 2016-01-21 2022-05-31 Cala Health, Inc. Systems, methods and devices for peripheral neuromodulation for treating diseases related to overactive bladder
WO2018058057A1 (en) * 2016-09-23 2018-03-29 Falowski Steven M Method and apparatus for intraoperative monitoring of lead placement in dorsal root ganglion stimulation
US10124178B2 (en) 2016-11-23 2018-11-13 Bluewind Medical Ltd. Implant and delivery tool therefor
US20180353764A1 (en) 2017-06-13 2018-12-13 Bluewind Medical Ltd. Antenna configuration
EP3421081B1 (en) 2017-06-30 2020-04-15 GTX medical B.V. A system for neuromodulation
ES2911465T3 (en) 2018-11-13 2022-05-19 Onward Medical N V Control system for the reconstruction and/or restoration of a patient's movement
EP3695878B1 (en) 2019-02-12 2023-04-19 ONWARD Medical N.V. A system for neuromodulation
US11065461B2 (en) 2019-07-08 2021-07-20 Bioness Inc. Implantable power adapter
US11890468B1 (en) 2019-10-03 2024-02-06 Cala Health, Inc. Neurostimulation systems with event pattern detection and classification
EP3827871A1 (en) 2019-11-27 2021-06-02 ONWARD Medical B.V. Neuromodulation system
US11400299B1 (en) 2021-09-14 2022-08-02 Rainbow Medical Ltd. Flexible antenna for stimulator

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3893462A (en) * 1972-01-28 1975-07-08 Esb Inc Bioelectrochemical regenerator and stimulator devices and methods for applying electrical energy to cells and/or tissue in a living body
US3995644A (en) * 1975-09-16 1976-12-07 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Percutaneous connector device
US4408609A (en) * 1980-04-01 1983-10-11 Professional Staff Association Of The Rancho Los Amigos Hospital, Inc. Electrical muscle stimulation for treatment of scoliosis and other spinal deformities
US4406288A (en) * 1981-04-06 1983-09-27 Hugh P. Cash Bladder control device and method
US4535785A (en) * 1982-09-23 1985-08-20 Minnesota Mining And Manufacturing Co. Method and apparatus for determining the viability and survival of sensori-neutral elements within the inner ear
US4519394A (en) * 1983-03-07 1985-05-28 Trustees Of The University Of Pennsylvania Method and apparatus for cathodic potential control in electrically induced osteogenesis
US5094242A (en) * 1988-11-07 1992-03-10 Regents Of The University Of California Implantable nerve stimulation device
US5056518A (en) * 1990-07-02 1991-10-15 Electro-Biology, Inc. Optimization of bone formation at cathodes
US5557210A (en) * 1992-11-20 1996-09-17 Pacesetter, Inc. Universal cable connector for temporarily connecting implantable stimulation leads and implantable stimulation devices with a non-implantable system analyzer
US5441520A (en) * 1993-04-06 1995-08-15 Hewlett-Packard Corporation Defibrillator patient connection system with automatic identification
US5769875A (en) * 1994-09-06 1998-06-23 Case Western Reserve University Functional neuromusclar stimulation system
US5695495A (en) * 1995-11-20 1997-12-09 Ellman; Alan G. Electrosurgical electrode for sclerotherapy
US5983141A (en) 1996-06-27 1999-11-09 Radionics, Inc. Method and apparatus for altering neural tissue function
US5782892A (en) * 1997-04-25 1998-07-21 Medtronic, Inc. Medical lead adaptor for external medical device
AU8897298A (en) * 1997-08-01 1999-02-22 Harbinger Medical, Inc. System and method of noninvasevely determining a patient's susceptibility to arrhythmia
US6055453A (en) * 1997-08-01 2000-04-25 Genetronics, Inc. Apparatus for addressing needle array electrodes for electroporation therapy
US5906634A (en) * 1997-08-08 1999-05-25 Cardiac Pacemakers, Inc. Implantable device having a quick connect mechanism for leads
US5857968A (en) * 1997-11-24 1999-01-12 Benja-Athon; Anuthep Coupling device in electroacupuncture
GB2336214A (en) 1998-01-16 1999-10-13 David William Taylor Preventionof multiple use of limited use devices
US6493588B1 (en) * 1998-03-18 2002-12-10 Mmc/Gatx Partnership No. 1 Electro-nerve stimulator systems and methods
US6141585A (en) * 1998-05-08 2000-10-31 Intermedics Inc. Implantable cardiac stimulator with electrode-tissue interface characterization
US6516227B1 (en) * 1999-07-27 2003-02-04 Advanced Bionics Corporation Rechargeable spinal cord stimulator system
US6904324B2 (en) * 1999-12-01 2005-06-07 Meagan Medical, Inc. Method and apparatus for deploying a percutaneous probe
US6701190B2 (en) * 2000-10-10 2004-03-02 Meagan Medical, Inc. System and method for varying characteristics of electrical therapy

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
None
See also references of EP1444004A4

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9265941B2 (en) 2001-10-18 2016-02-23 Uroplasty, Llc Lead set for nerve stimulator and method of operation thereof
US9056194B2 (en) 2001-10-18 2015-06-16 Uroplasty, Llc Lead set for nerve stimulator and method of operation thereof
US8812114B2 (en) 2001-10-18 2014-08-19 Uroplasty, Inc. Lead set for nerve stimulator and method of operation thereof
US7729772B2 (en) 2005-01-07 2010-06-01 Uroplasty, Inc. Implantable neuromodulation system and method
US20140073985A1 (en) * 2005-03-01 2014-03-13 Checkpoint Surgical, Llc Stimulation device adapter
US11576599B2 (en) 2005-03-01 2023-02-14 Checkpoint Surgical, Llc Stimulation device adapter
US10154792B2 (en) * 2005-03-01 2018-12-18 Checkpoint Surgical, Inc. Stimulation device adapter
US7676271B2 (en) 2005-03-11 2010-03-09 Medtronic, Inc. Neurostimulation site screening
US9149628B2 (en) 2005-03-11 2015-10-06 Medtronic, Inc. Neurostimulator for treating occipital neuralgia with housing sized and curved to conform to a subcutaneous neck region
US8295936B2 (en) 2005-03-11 2012-10-23 Medtronic, Inc. Implantable neurostimulator device
US8620437B2 (en) 2005-03-11 2013-12-31 Medtronic, Inc. Method for delivery of electrical stimulation with bendable housing
US7231256B2 (en) 2005-03-11 2007-06-12 Medtronic, Inc. Neurostimulation site screening
US8744582B2 (en) 2005-03-11 2014-06-03 Medtronic, Inc. Implantable neurostimulator device with bellows-like element coupling first and second housing portions
WO2006098823A1 (en) * 2005-03-11 2006-09-21 Medtronic, Inc. Neurostimulation site screening
US7555345B2 (en) 2005-03-11 2009-06-30 Medtronic, Inc. Implantable neurostimulator device
US7664552B2 (en) 2005-03-11 2010-02-16 Medtronic, Inc. Neurostimulation site screening
US8046082B2 (en) 2006-05-18 2011-10-25 Uroplasty, Inc. Method and apparatus for stimulating a nerve of a patient
US7668598B2 (en) 2006-05-18 2010-02-23 Uroplasty, Inc. Method and apparatus for stimulating a nerve of a patient
US9427572B2 (en) 2007-10-26 2016-08-30 Medtronic, Inc. Implantable medical device with connector blocks
US9008782B2 (en) 2007-10-26 2015-04-14 Medtronic, Inc. Occipital nerve stimulation
WO2012000003A1 (en) 2010-06-30 2012-01-05 Biegler Gmbh Electrical stimulation device

Also Published As

Publication number Publication date
ES2377946T3 (en) 2012-04-03
DK1444004T3 (en) 2012-03-12
PT1444004E (en) 2012-02-17
EP1444004A2 (en) 2004-08-11
ES2450465T3 (en) 2014-03-24
EP1444004A4 (en) 2006-07-19
AU2002349957A1 (en) 2003-04-28
EP1444004B1 (en) 2011-12-14
DK2308553T3 (en) 2014-03-10
EP2308553A1 (en) 2011-04-13
CA2463936C (en) 2013-04-02
EP2308553B1 (en) 2014-01-29
US7536226B2 (en) 2009-05-19
PT2308553E (en) 2014-03-04
US20050171576A1 (en) 2005-08-04
WO2003033068A3 (en) 2004-03-11
CA2463936A1 (en) 2003-04-24
ATE536907T1 (en) 2011-12-15

Similar Documents

Publication Publication Date Title
US7536226B2 (en) Electro-nerve stimulator system and methods
US10869999B2 (en) Systems and methods for treating shoulder pain related to subacromial impingement syndrome
US9265941B2 (en) Lead set for nerve stimulator and method of operation thereof
EP2024006B1 (en) Apparatus for stimulating a nerve of a patient
AU2011248594B2 (en) Systems and methods for percutaneous electrical stimulation
US20020151951A1 (en) Electrical stimulation compress method
AU2011248594A1 (en) Systems and methods for percutaneous electrical stimulation
US8480427B2 (en) Cable connector
CN115461935A (en) Stimulation lead connection system
EP2024017A2 (en) Lead set for nerve stimulator and method of operation thereof
US20240099632A1 (en) Nerve stimulation patterns and device for detectability of nerve function and health
Fee Jr Neuro-Trace: A New Intraoperative Nerve Stimulator

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BY BZ CA CH CN CO CR CU CZ DE DM DZ EC EE ES FI GB GD GE GH HR HU ID IL IN IS JP KE KG KP KR LC LK LR LS LT LU LV MA MD MG MN MW MX MZ NO NZ OM PH PL PT RU SD SE SG SI SK SL TJ TM TN TR TZ UA UG US UZ VN YU ZA ZM

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GH GM KE LS MW MZ SD SL SZ UG ZM ZW AM AZ BY KG KZ RU TJ TM AT BE BG CH CY CZ DK EE ES FI FR GB GR IE IT LU MC PT SE SK TR BF BJ CF CG CI GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2463936

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 2002786437

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 2002786437

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 10492578

Country of ref document: US

NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP