GB2509750A

GB2509750A - Stimulating needle with plurality of electrode zones

Info

Publication number: GB2509750A
Application number: GB201300540A
Authority: GB
Inventors: Teodor Goroszeniuk
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-01-11
Filing date: 2013-01-11
Publication date: 2014-07-16
Also published as: GB201300540D0

Abstract

A stimulating needle 10 in accordance with the invention comprises a solid stiffly flexible element 12 of a conductive wire having an exposed sharpened distal end 14 and a plurality of exposed stimulating zones 22 along its length, the wire having means for connection to a signal generator or control unit 20, and a convenient finger grip 18 to allow the stimulating needle 10 to be accurately controlled during insertion into a patient. The non-stimulating zones 16 along the length of the needle 10 are conveniently masked by means of insulating material so that only the stimulating zones can in use apply a current to a patient. The needle 10 may be hollow to allow injection of pain killers and anaesthetics.

Description

IMPROVEMENTS IN AND RELATING TO STIMULATING NEEDLES

This invention relates to improvements in and relating to stimulating needles for the treatment and relief of acute and chronic pain.

A stimulating needle is a sharp needle that is connected to a signal generator or control unit that is arranged to provide a stimulating signal to locate and/or to achieve temporary or permanent relief of chronic or acute pain in a patient.

In my earlier UK patent applications numbers 2407272 and 2434547 I described implantable devices and their application to treat long-term pain by means of low intensity, low frequency electrical signals applied to stimulating electrodes. The devices were designed to be inserted in a patient through a hollow, cylindrical stimulating needle. The devices have proved very successful; their operation has been able to be controlled remotely to adapt the treatment, if necessary, to the evolution of the pain. But once inserted they require a small surgical intervention to remove or relocate them.

A stimulating needle in accordance with the invention comprises a solid stiffly flexible element of a conductive wire having an exposed sharpened distal end and a plurality of exposed stimulating zones along its length, the wire having means for connection to a signal generator or control unit, and a convenient finger grip to allow the stimulating needle to be accurately controlled during insertion into a patient. The non-stimulating zones along the length of the needle are conveniently masked by means of insulating material so that only the stimulating zones can in use apply a current to a patient.

Such a stimulating needle which may be from 10 to 20cm in length or longer can be inserted into a patient in a region where the patient is experiencing acute or chronic pain and an electrical signal applied for short duration in order to provide relief, and then withdrawn. Typically the needle will be inserted for between five and thirty minutes for the desired relief to be achieved. It can then be withdrawn and the patient can return home; relief will generally last for days, weeks, or even months. When the patient returns for further treatment, the pain may have developed, or even moved, so that the flexibility of the treatment is total.

The needle is intended to be used with a reference electrode, typically a patch of conductive silicone. The multiple treatment by means of the stimulating tip of the needle with the multiple electrodes along the needle provides exceptional relief.

Whilst the needle must be sufficiently stiff to puncture the skin, it needs to be sufficiently flexible to be able to follow a muscle or under a patient's skin, or his spine, for example. In practice this limits the diameter of the needle to 18 gauge at the silifest, and 22 gauge as the finest. 20 gauge has been found to be particularly suitable. A needle with an active' length of 15cm between the sharpened distal tip and the finger-hold at the other end appears to be an optimum.

The length of the exposed tip of the needle, and of the exposed stimulating zones along the needle may be up to 10mm in length, though the optimum length of these zones appears to be between 1 or 2 and 5mm; 3mm is particularly suitable.

In a variant of the needle, it may have a passage along its centreline to allow injection of a pain relief drug to complement the treatment. This may require a needle of a greater cross-section, for example 16 gauge or even 14 gauge to achieve a passage of sufficient diameter whilst retaining the desired stiffness.

Patients respond differently to electrical stimulation for treatment of pain. In some cases a signal at ito 50 Hz, preferably between 2 and 10 Hz provides substantial relief when a current of 1 to 15 mA, preferably 2 to 10 mA is applied. More recently I have tound that some patients respond well to higher frequencies of up to 25 kHz or highei. In general a mono polar square wave is applied with a wave-duration of 0.5 to 1 ms though treatment may be varied to obtain the optimum benefit, that may range from a duration of 0.OSms to 10 or i2 ms depending on the severity of the pain and the tolerance of the patient.

The exact location to be treated may be located either using the stimulating needle itself or a transcutaneous stimulating device.

The invention will now be further described by way of example with reference to the accompanying drawing which shows diagrammatically a stimulating needle in accordance with the invention.

A stimulating needle 10 in accordance with the invention comprises a stiffly flexible element 12 of a conducting wire having an exposed sharpened distal end 14 and a plurality of exposed stimulating zones 16 along its length. At its outer end 18, the wire has means 20 for connection to a signal generator or control unit (not shown), and a finger grip, which may be shaped as a finger hold, to allow the stimulating needle to be accurately inserted and controlled during insertion into a patient.

The needle has non-stimulating zones 22 along its length, that are masked by means of insulating material so that only the stimulating zones can in use apply a current to a patient. The stimulating zones 22 needle may be between 1 and 10mm in length axially, though more commonly are between 2 and 5mm and ideally are 3mm in length.

The length of the needle may be between 10 and 20cm though 15cm has been found to be suitable for most applications.

The needle may be made of conductive wire of a gauge of between 14 and 22 gauge. Where the needle is made of hollow wire 14 to 20 gauge is suitable; hollow 18 gauge wire is suitable to allow the injection of pain killers.

Where solid conductive wire is used between 18 gauge and 22 gauge is suitable, though 20 gauge is found to be best.

The stimulating needle may be attached to a standard stimulating unit, and used with a reference electrode, of say a sticky conductive silicone compound.

Claims

CLAIMS1. A stimulating needle cornpiising a stiffly flexible element of a conducting wire having an exposed sharpened distal end and a plurality of exposed stimulating zones along its length, the wire having means for connection to a signal geneiator oi control unit, and a finger grip to allow the stimulating needle to be accurately controlled during insertion into a patient.
2. A stimulating needle as claimed in claim 1 in which the non-stimulating zones along the length of the needle are masked by means of insulating material so that only the stimulating zones can in use apply a current to a patient.
3. A stimulating needle as claimed in claim 1 or 2 in which the stimulating zones on the needle are between 1 and 10mm in length axially.
4. A stimulating needle as claimed in claim 3 in which the stimulating zones are between 2 and 5mm in length axially.
5. A stimulating needle as claimed in claim 4 in which the stimulating zones are 3mmin length axially.
6. A stimulating needle as claimed in any preceding claim in which the length of the needle is between 10 and 20 cm.
7. A stimulating needle as claimed in claim 6 in which the length of the stimulating needle is 15 cm.
8. A stimulating needle as claimed in any preceding claim in which the outer end of the needle is provided with a finger grip to enable it to be manipulated and accurately located.
9. A stimulating needle as claimed in any preceding claim in which the needle is made of conductive wire of a gauge of between 14 and 22 gauge.
10. A stimulating needle as claimed in claim 9 in which the needle complises hollow wile of 14 to 20 gauge, pieferably 18 gauge to allow the injection of pain killers.S
11. A stimulating needle as claimed in claim 9 in which the needle comprises solid conductive wire of between 18 gauge and 22 gauge, and pieferably 20 gauge.
12. A stimulating needle as claimed in any preceding claim and substantially as heiein desciibed with reterence to the accompanying drawing.