CA1097549A

CA1097549A - Cryosurgical probe

Info

Publication number: CA1097549A
Application number: CA283,154A
Authority: CA
Inventors: John W. Lloyd; David E. Wild; Humphry R. Evatt
Original assignee: Spembly Ltd
Current assignee: Spembly Ltd
Priority date: 1976-07-21
Filing date: 1977-07-20
Publication date: 1981-03-17
Also published as: JPS5644750B2; JPS5313579A; DE2732486C2; DE2732486A1; GB1534162A; FR2358874A1; US4207897A; NL7708092A

Abstract

ABSTRACT OF THE DISCLOSURE

A cryosurgical probe is adapted for the freezing of a nerve and is fitted with an electrode at its tip for electrical stimulation of the nerve, to enable the surgeon to know when the probe tip has been correctly placed in proximity to a particular nerve which it is desired to freeze.

Description

~75~9 BACKGROUND OF THE INVENTION

Field of the Invention This invention relates to cryosurgery, which is the use of freezing in surgery, and in particular to the freezing of nerves.
SUMMARY
In its broadest aspect, the invention is a cryosurgi-cal probe equipped with nerve-stimulating means.
From another aspect, the invention is a cryosurgical probe comprising a hollow stem of which one end is adapted to be connected to a source of cooling fluid and to exhaust and of which the other end is closed and is formed as a tip of thermally conductive material adapted to be cooled by means of the cooling fluid, which in use flows along the stem; where-by localised cooling of animal tissue in a part of a living animal (human or otherwise) can be effected by application of the tip to the tissue; the tip including, or being formed as, at least one exposed electrode; said at least one exposed electrode being electrically connectible to an electrical source for application of an electrical stimulus to the tissue in the vicinity of the electrode.
Preferably the probe is adapted to be used with a cooling fluid in the form of the gas or vapour boiled off from liquified gas having a boiling point substantially below normal ambient temperature at normal atmospheric pressure, and is adapted to be cooled at least partly due to the Joule-Thompson effect upon expansion of the gas or vapour inside

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5`~9 the stem.
The said exhaust may be directly into atmosphere (if the nature of the fluid permits) or ducted away.
Preferably the electrode and conductor are respec-tively a single electrode and a single conductor and the probe is adapted to be used in conjunction with a separate electrode applied in use to another part of the animal.
Preferably the stem has a thermally and electrically insulating outer layer, elsewhere than at the tip, for example, a layer of polytetrafluoroethylene (P.T.F.E.).

Preferably the tip incorporates the measuring junction of a thermocouple, and electrical leads of the thermocouple extend along the stem. One of said leads may be the said electrical conductor connected to the said electrode.
A preferred application of the invention is to a method of chilling or freezing a neurone, in which the electri-cal stimulus enables a surgeon or anaesthetist to locate the neurone and/or determine the extent of the chilling or freez-ing of the neurone, by observing the animal's response to the stimulus.

Preferably the tip is sharp so that it can be intruded beneath the surface of the tissue, whether it be an internal surface exposed by surgery or accident or an external surface, e.g. skin. However, the tip need not be sharp if the probe is required only for internal use during an operation or for external use.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 illustrates a cryosurgical probe and associated apparatus embodying the invention;
Figure 2 is a section through a front end portion of the stem of the probe of Figure l;

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Figure 3 illustrates use of the apparatus of Figure 1 on a patient; and Figure 4 illustrates use of a modified apparatus on a patient.
DESCRIPTION OF THE PREFER~ED EMBODIMENT
Referring to Figures 1, 2 and 3, the illustrated apparatus 10 comprises a cryosurgical probe 11, a control unit 12, a flexible lead 13 which connects the probe 11 to the control unit 12 and which contains ducts (not shown) for the supply of cooling fluid to the probe and for return flow of the cooling fluid and electrical leads. The apparatus 10 also comprises a nerve-stimulator unit 14 which is connected to the control unit 12 by a flexible electrical lead 15 and is connected to an electrode 16 by a lead 17.
The cryosurgical probe 11 comprises a handle 18 con-nected to a hollow stem 19. The end (not shown) inside the handle 18 of stem 19 is adapted to be connected to a source (not shown) of cooling fluid and to exhaust, via the lead 13.
The other end 20 of stem 19 is closed and is formed as a tip of thermally conductive material adapted to be cooled by means of the cooling fluid, which in use flows along the ste~ 19.
Referring more particularly to Figure 2, the stem 19 comprises a tube 21 of stainless steel, covered with a layer 22 of P.T.F.E. (in the form available under the Registered Trade Mark "TEFLON"). Inserted in the front end of the tube 21 is a stainless steel insert 23, sharpened to an 18 long bevel as shown, to form the tip 20 of the stem 19. Inside the tube 21 is a stainless steel gas inlet tube 24, formed at its front end with an expansion orifice 25. Cooling fluid issuing from the orifice 25 serves to cool the stainless steel insert 23, the cooling fluid returning along the interior of the tube 21, outside the tube 24, as illustrated by arrows 26.

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Another stainless steel tube 27 contains two electrical leads 28, leading to a thermocouple junction 29 at the face 30 of the bevel, the thermocouple junction 29 being electrically insulated from the stainless steel insert 23 by a plug 31 of plastics insulating material.
The stainless steel insert 23 forms an exposed electrode at the tip 20 of stem 19, and being in direct contact with the stainless steel tube 21, is electrically connected via the tube 21, lead 13, unit 12 and lead 15 to the unit 14, which is adapted to supply electrical pulses to the electrode formed by insert 23 as an electrical stimulus to the animal tissue (see Figure 3) in the vicinity of the insert 23. The layer 22 of P.T.F.E. forms a thermally and electrically insulat-ing outer layer around the stem 19, elsewhere than at the tip 20.
The lead 13 is provided with a screw-threaded coupling 32, engageable in a socket 33 in the control unit 12, for the supply and exhaust of cooling fluid. An electrical connector 34 is connected by a jumper lead 35 to the connector 32 and is engageable in a socket 36 in the control unit 12.
The illustrated apparatus is used with a bottle ~not shown) of cooling fluid in the form of liquified gas such as liquid carbon dioxide or liquid nitrous oxide, which has a boiling point substantially below normal ambient tempera-ture at normal atmospheric pressure. In use, the bottle of liquid gas (not shown) is connected by means not shown to the control unit 12, whence gas ox vapour boiled off from the liquid gas flows along lead 13 into the tube 24 inside stem 19, issuing from the orifice 25 inside the stem 19 and having the effect of cooling the tip (for example down to a temperature of -40C) at least partly due to the Joule-Thompson effect upon expansion of the gas or vapour inside the stem 19. The tempera-.~

~75-~9 ture in the region of the face 30 of the bevelled tip 20 is detected by the thermocouple junction 29 and can be read on a meter 37 on the control unit 12. The rate of flow of cooling vapour along the tube 24 can be controlled by means of a rotary control knob 38 on the control unit 12, for controlling the temperature of the tip 20. It will be appreciated that the temperature indicated by the meter 37 is at best only the tèmperature of the stem tip 20, not the temperature of the tissue to which thestem tip 20 has been applied, but neverthe-less the meter 37 provides a useful indication of the effective-ness of the probe 11 for cooling the tissue, and can show when the tip 20 has cooled down sufficiently for use, as well as (more importantly) indicating when cooling is not as rapid or effective as usual, due to some malfunction. A pressure gauge 39 on control unit 12 indicates the supply pressure of the cooling gas or vapor.
In use, referring to Figure 3, the patient (indicated by reference 40) is laid on an operating table 41, in electrical contact with the electrode 16 as shown. The surgeon or anaesthetist (indicated by reference 42) may then intrude the probe tip 20 into the patient, the tip 20 being sufficiently sharp for intrusion without unacceptable traumatic effect on the patient.
By means of the nerve stimulator unit 14, electrical pulse stimuli are applied to the patient via the stainless steel insert 23. If the probe tip 20 is close to a nerve which it is desired to freeze by means of the probe 11, the electrical stimulus has an observable effect upon the patient, for example, causing twitching of a particular muscle, whereby the surgeon or anaesthetist can ascertain the proximity or otherwise of the probe tip 20 to the desired nerve. When the surgeon or anaesthetist is reasonably sure that the probe tip 20 is as near as possible to the nerve, from observing the effect of 7S~

the electrical stimulus on the patient, the cooling fluid can be switched on to effect freezing of the nerve, during which time the probe 11 is held motionless with the probe tip 20 in close proximity to the nerve. During this time, progressively decreasing reaction of the patient to the electrical stimulus will indicate freezing of the nerve, or neurone. When the surgeon or anaesthetist is satisfied that sufficient freezing of the nerve or neurone has taken place, the flow of cooling fluid is cut off and the tip 20 is allowed to ~haw. When the tip 20 has thawed sufficiently, as indicated by the meter 37, the probe 11 may be withdrawn from the patient. It will be appreciated that the probe 11 must not be moved until it has thawed, because the frozen tip 20 will stick to adjacent tissue ïn the patient. Preferably, a first freezing and thawing cycle is followed by a second such cycle, the freezing period of each said cycle being from 1 1/2 to 3 minutes, to ensure freezing of the nerve.
The pulse repetition rate of the nerve stimulator unit 14 is one pulse per second approximately, the pulse voltage being selectively variable. Instead of nitrous oxide, the liquified gas may be carbon dioxide.
Instead of observing muscular contraction of the patient, if the patient is conscious the surgeon or anaesthetist may rely upon verbal communication with the patient. It is important for the area of contact with the patient of electrode 16 to be large enough to avoid stimulating the patient except at the location of the probe tip ~0.
Gas pressure may be around 600 pounds per square inch, in which case the minimum temperature obtainable at the probe tip bevel face 30 is -80C in air or -60C within the patient, the time to reach minimum temperature being approximately 45 seconds, a typical freeze period 1 1/2 to 3 minutes, a typical rewarm time approximately 1 minute. The length of the probe 75^~9 stem 19 is preferably about 100 millimetres, its diameter 1.8 millimetres.
The nerve stimulator unit ]4 may be a "Welcomme-Burroughs peripheral nerve stimulator unit", with a maximum output o 200 volts, giving a substantially instantaneous voltage rise to a preset level, followed by exponential de-cay with a time constant of 0.1 milliseconds, independent of load. The stimulator unit 14 is also capable of delivering a tetanic stimulation with the same voltage waveform with spikes up to 200 volts with a 28 millisecond repetition rate (i.e.
35 Hz) at a 20 Kilohm output impedance.
In the modified apparatus illustrated in Figure 4, the same control unit 12 and stimulator unit 14 are used as in Figure 3. However, a modified cryosurgical probe 11' has a modified probe tip (not shownl with two spaced-apart exposed electrodes electrically connected as shown to opposite terminals of the nerve stimulator unit 14, dispensing with the need for the electrode 16 of Figure 3. Because the electrodes at the tip of probe 11' of Figure 4 are relatively close together, compared with the distance between the probe tip 20 and electrode 16 of Figure 3, a much higher voltage is required for stimulating the patient.
In Figures 3 and 4, the electrical connections are shown purely diagrammatically.

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Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A cryosurgical device comprising a probe having a hollow stem, one end of the stem having means adapted to be connected to a source of cooling fluid and to exhaust, the opposite end of the stem being closed and having a thermally conductive tip adapted to be cooled by means of the cooling fluid which in use flows along the stem, whereby human or animal tissue at the tip may be cooled, said tip providing an exposed electrode, a further electrode separate from said probe and adapted to be applied to a part of said human or animal separate from the tissue to be cooled, and means for applying electrical nerve-stimulating voltages between the said electrodes sufficient to cause an observable muscle response in the human or animal.

2. A device as claimed in claim 1, wherein the probe is adapted to be used with a cooling fluid in the form of a gas or vapour boiled off from a liquefied gas having a boiling point substantially below normal ambient temperature at normal atmospheric pressure.

3. A device as claimed in claim 2, wherein the probe is adapted to be cooled at least partly due to the Joule-Thomson effect upon expansion of the gas or vapour inside said stem.

4. A device as claimed in claim 1, wherein the stem has a thermally and electrically insulating outer layer, elsewhere than at the tip.

5. A device as claimed in claim 4, wherein the tip incorporates the measuring junction of a thermocouple and electrical leads of the thermocouple extend along the stem.

6. A device as claimed in claim 1, wherein the tip is sharp so that it can be intruded beneath the surface of the tissue.

7. A device as claimed in claim 1, wherein the means for applying electrical nerve-stimulating voltages produces voltage pulses.

8. A cryosurgical device comprising a probe having a hollow stem, one end of the stem having means adapted to be connected to a source of cooling fluid and to exhaust, the opposite end of the stem being closed and having a thermally conductive tip adapted to be cooled by means of the cooling fluid which in use flows along the stem, whereby human or animal tissue at the tip may be cooled, said tip having a pair of exposed electrodes, and means for applying electrical nerve-stimulating voltages between the said electrodes sufficient to cause an observable muscle response in the human or animal.

9. A device as claimed in claim 8, wherein the means for applying electrical nerve-stimulating voltages produces voltage pulses.