WO1980002794A1

WO1980002794A1 - Fixation ring for transcutaneous gas sensor probe

Info

Publication number: WO1980002794A1
Application number: PCT/US1980/000769
Authority: WO
Inventors: C Dali; D Rich
Original assignee: Novametrix Med Syst Inc
Priority date: 1979-06-20
Filing date: 1980-06-20
Publication date: 1980-12-24
Also published as: US4280505A; EP0030965A1

Abstract

A fixation ring (19) for a transcutaneous gas sensor probe (1) has structure for removably mounting the ring on the probe with a bore in the ring communicating with the electrodes (5, 7) of the probe. The fixation ring includes a membrane (29) and structure for tensioning the membrane in cooperation with the probe when the fixation ring is attached to the probe at which time the membrane permits only gases to which it is permeable to pass through the bore in the fixation ring and into an ion solution in contact with the electrodes of the probe. A cap member (38) removably mountable on the fixation ring is provided with an element (41) for depressing the membrane to prevent excessive ion solution and any entrapped air from accumulating adjacent to the electrodes.

Description

FIXATION RING FOR TRANSCUTANEOUS GAS SENSOR PROBE

Background of the Invention

This invention relates to transcutaneous gas sensor probes used for the measurement of transcutaneous gases emitted through the skin of a living body. More specifically, the invention concerns a fixation ring upon which a membrane permeable to the gas to be measured but impermeable to an ion solution can be premounted and packaged under clean conditions to be later connected to the active portion of a transcutaneous gas sensor probe without need for special handling, instruments or skill.

It is known in the medical art of non-invasive blood gas content monitoring and measurement to apply to the surface of the skin of a person whose blood gas content is to be monitored and measured, a probe having a barrier permeable to the gas to be measured or monitored and impermeable to other gases as well as to an ion solution in which the gas which is to be monitored and measured is soluable. Such probes generally include a first electrode or anode, a second electrode or cathode, an ion solution in contact with the anode and cathode and a membrane spanning a region between the anode and cathode and maintaining a supply of the ion solution in contact with the anode and cathode. A particular gas which is emitted from the skin of a living body is permitted to permeate through the membrane and into the ion solution where it has an effect on the flow of current between the cathode and anode foT permitting an electrical mea¬ surement indicative of the quantity of the gas emitted from the skin.

In the use of conventional transcutaneous gas probes, membranes are at¬ tached to the probes by the physician or technician applying each probe before its application. This requires difficult handling by highly skilled personnel who must use special tools to install the membranes with a fastener, such as an O- ring. Such preparation is required with each use of the probe. The membranes are small, light, susceptible to damage from improper handling, and generally difficult to install in a transcutaneous gas probe. Once installed, the membranes

^'_> are likely to shift relative to the electrodes, thereby resulting in displacement of the electrolyte and upsetting the calibration, sensitivity and stability of the probe. Also, the difficulty in changing the membranes on prior art probes en¬ courages the repeated use of membranes which should be changed after each use thereby creating unsanitary conditions.

It is known in the prior art to employ a separate attachment ring with a transeutaneous gas sensor probe which attachment ring can be attached to the skin of a patient and which is adapted to receive the active part of the probe. Such attachment rings are beneficial in that they obviate the need to sterilize the probe between patient uses. Since only the attachment ring is brought into contact with the skin of the patient, only it need be sterilized between uses. Such attachment rings can also be provided with adhesive coatings on their sur¬ faces adapted to engage the skin of the body for securing a transcutaneous gas sensor probe in place on the surface of the skin. A transcutaneous gas sensor probe having a removable attachment ring with an adhesive coating is disclosed in German patent specification no. 27 24 461, issued to Radiometer A/S of Co¬ penhagen, Denmark, for a sensor for transcutaneous electrochemical measureme Although the probe disclosed in the German patent obviates the need for sterili ing the entire probe with each use and provides a positive method of affixing t probe to the skin surface of a patient, it does not solve the above described problem of attaching the membrane to the probe without the performance of a relatively difficult operation. Moreover, prior art probes do not provide for a sufficiently positive engagement of the membrane by the sensor to prevent sub¬ stantial movement between the membrane and electrodes which can degrade measurement readings and necessitate reealibration of the probe.

Summary of the Invention

_

The present invention overcomes the problems .of the prior art in providing a transcutaneous gas sensor probe having a removable fixation ring to which the probe membrane can be affixed prior to application of the fixation ring to the sensor probe. Specifically, the present invention teaches the construction and u of a fixation ring adapted to be mounted on a transcutaneous gas sensor probe having a cathode and anode and ion solution in . contact with the cathode and anode. The fixation ring has mounted within it a membrane for maintaining th solution in engagement with the cathode and anode and permitting a gas to be measured to permeate into the ion solution. The fixation ring further includes housing having .£ probe end and a body end with a bore running from the probe end to the body end of the housing, means for removably mounting the fixation ring on the probe with the probe end of the fixation ring in engagement with t probe, and means for mounting the membrane on the fixation ring proximate th body end and in sealing relationship with the bore so that only a gas to which the membrane is permeable can pass through the bore from the body skin surfa

OOMM at which it is emitted and into the sensor probe. The invention provides for the mounting of a cover ring on the fixation ring which helps compress the periphery of the membrane to tension it and provides a skin engaging surface which can optionally be provided with an adhesive coating for adherence to the skin. The fixation ring is dimensioned so that the body end of the probe, which is urged against the membrane when the fixation ring is attached to the probe extends slightly beyond the cover member thereby tensioning the membrane against the holding force of the cover ring to limit movement of the membrane with respect to the probe and thus ensure the precision and accuracy of transcutaneous gas measurements. A cap member can be removably attached to the fixation ring for protecting the membrane prior to use, and resiliently urging the membrane toward the electrodes to bleed any entrapped air from the system and displace excess electrolyte between the membrane and the electrodes, and to cause the membrane to conform to the profile of the electrode surfaces thereby further en¬ hancing gas measurements.

Other and further objects of the invention will be apparent from the follow¬ ing drawings and description of a preferred embodiment of the invention in which like reference numerals are used to indicate like parts in the various views.

Description of the Drawings

Figure 1 is a sectional elevation of a fixation ring, embodying the invention in its intended environment.

Figure 2 is an enlarged fragmentary sectional elevation of a portion of the preferred embodiment of the invention in its intended environment.

Figure 3 is an exploded perspective view of the apparatus of the preferred embodiment of the invention.

Description of the Preferred Embodiment

Referring now to Figure 1 of the drawings, there is shown a transcutaneous gas sensor prope 1, including a housing 3 in which there is mounted an anode 5 formed from a solid billet of a conductive material such as silver and a cathode 7, which for purposes of illustration is shown to be a hollow cylindrical glass tube partially filled with an electrolyte solution in which there is suspend¬ ed a silver-silver chloride wire electrode 9. Such electrodes are known for use in measuring carbon dioxide gas emitted through the skin of a living body. However, it is to be appreciated that the present invention is not to be limited to use with probes for measuring carbon dioxide and will have application with probes used for measurement of other transcutaneous gases such as oxygen. In the case of an oxygen probe, for example, the cathode may differ from the one shown in Figure 1 and will often include a plantinum wire mounted within a solid glass rod with the end of the wire substantially coextensive with the end of the rod.

Also shown mounted within the transcutaneous gas sensor probe of Figure 1 is a temperature sensitive element 11 which can be a thermistor or a field ef¬ fect transistor for generating a signal indicative of the temperature of the anode 5. The anode 5, cathode 7 and the thermister 11 are connected to elec ¬ tronic circuitry for processing and amplification, part of which can be housed in a module 13 within the housing of the probe, and are connected by wires 15 extending from the probe housing 3 to external processing circuitry and monitor¬ ing devices.

The housing 3 has a cylindrical upper portion of enlarged diameter forming a grasping end at which the probe 1 can be conveniently held and a lower cylin¬ drical body portion of lesser diameter terminating in a body end adapted to be urged against the skin of a living body. On the exterior wall of the lower cylindrical body portion, there are provided threads 17 adapted to mate with corresponding threads in the interior bore of a housing 19 of a removable fixatio ring. The fixation ririg has a probe end 21 which engages the shoulder formed a the juncture of the enTarged diameter and lesser diameter portions of the probe housing 3 when the fixation ring is fully threaded on the housing 3 and a body end 23 adapted to be urged towards the skin of the body of a patient when the probe 1 is applied for transcutaneous gas measurement. The second hosuing 19, that is the housing of the fixation ring, has a circular bore running its full lengt from the probe end 21 to the body end 23 of the fixation ring. The bore of the housing 19 tapers slightly outwardly toward the body end while the outer circum¬ ference of the lesser diameter portion- of the first or probe housing 3 tapers slightly inwardly toward its body end, thereby leaving a void between the outer wall of the hoysing 3 and the adjacent inner wall of the fixation ring housing 19.

As can be seen with the additional aid of Figure 3, the fixation ring hous¬ ing 19 has axially directed outer and inner circumferential ridges 25 and 27 respectively. The inner circumferential ridge 27 of the fixation ring housing 19 is adapted to support the overlapping periphery of a membrane 29 which can be affixed to the inner ridge 27 by means of a resiliency expandable O-ring or snap-ring 31. The snap-ring 31 can be forced over the peripheral surface region of the membrane 29 and onto the outer circumference of the inner ridge 27 to affix the membrane 29 to the housing 19 in a tensioned state thereby sealing the bore at the body end of the housing 19. The membrane 29, when so affixed, prevents substantially all matter, except that to which the membrane 29 is permeable, from passing into the bore in the housing 19 and entering an ion solution which is maintained within the probe 1 in contact with the anode 5 and cathode 7 by the ion impermeable membrane 29.

The membrane 29 is selected according to the transcutaneous gas which is to be mesaured. For example, if the gas is oxygen, a polypropylene material may be used for the membrane 29, whereas if the transcutaneous gas is carbon dioxide, a teflon membrane may be used. In order to control the amount of ion solution at the measuring surface at the cathode 7, an absorbant spacer element 33 can be disposed between the membrane 29 and the probe end of the fixation ring housing 19. The spacer element 33 is preferably formed from an absorbant material, such as cellulose. The element 33 absorbs the ion solution above the membrane 29 and provides a controlled amount of the solution, which is depen¬ dent upon the dimensions and absorbaney of the spacer 33, between the anode 5 and cathode 7 so that accurate and precise gas measurements can be made. The spacer element 33 and membrane 29 are mounted together on the ridge 27 by means of the snap-ring 31 with their adjacent surfaces in intimate contact.

The snap-ring -31 holds both the membrane 29 and spacer 33 securely on the fixation ring 19 by compressing the respective edges of the membrane 29 and spacer 33 against the interior ridge 27 of the housing 19. The exterior wall of the interior ridge 27 is frustoconical and slopes radially inwardly in a direction from the body end to the probe end of the fixation ring housing 19. The sloping wall prevents the snap-ring 31 from becoming dislodged from the ridge 27 once it is forced onto the ridge and into position to hold the membrane 29 and spacer 33 in place as shown in Figure 1.

A cover ring 35 is attached to the body end of the fixation ring 19 after the membrane_i_ 29 and spacer 33 are assembled to the housing 19 with the aid of the snap-ring 31. The cover ring 35 has an aperture at its center which is in alignment with the bore in the fixation ring housing 19 so that the central portion of the membrane 29 is exposed to the skin of the body to which the probe 1 is applied.

The plane of the membrane 29 is normally slightly recessed from the body surface of the cover ring 35 prior to attachment of the fixation ring housing 19 to the probe housing 3. However, the dimensions of the fixation ring are such that the distance from the probe end 21 to the body end 23 of the fixation ring housing 19 is slightly less than the distance of the probe hoasing shoulder abutted by the fixation ring probe end 21 to the body end of the probe housing 3. As a result of this relationship between the probe housin 3 and the fixation housing 19, the membrane engaging surface at the body end of the probe housing 3 extends slightly beyond the skin engaging surface at the body end of the fixation ring so that when the skin engaging surface at the body end of the cover ring 35 is held in contact with the surface of the skin, the body end of the housing 3 urges the spacer 33 and membrane 29 firmly against the skin, thereby enhancing the accuracy and precision of the measurement and obviating the possibility of relative movement between the body end of the probe 1 at whibh the gas sensing is accomplished and the skin. The body end of the cover ring 35 can be provided with a layer of an adhesive material 37 to adhere the probe 1 to the surface of the skin. The adhesive material 37 can be protected by a cover sheet (not shown) which has a lesser affinity for the adhesive material 37 than does the cover ring 35.

The cover ring 35, in addition to providing at its body end, a skin engagin surface for the probe 1, further aids in tensioning the membrane 29 and spacer 33 so that the membrane and spacer are drawn taut to conform to the body en of the probe 1 and are not subject to movement relative to the body end of th probe 1. Referring to Figure 2 of the drawings, it is seen that when the fixa¬ tion ring housing 19 is -threaded onto the probe housing 3, the body end of the probe housing 3 extends beyond a beveled membrane engaging edge 24 of the cover ring 35, which acts as a bearing surface for the membrane 29. As a result of this configuration, when the affixation ring with membrane installed is threaded onto the probe housing 3, the body end of the probe housing 3 and th body ends of the anode 5 and cathode 7 exert a force on the central portions of the spacer 33 and membrane 29 in a direction toward the body end of the probe while the cover ring 37 exerts an opposite force, that is in the probe direction, on the exterior portions of the membrane 29 and spacer 33. The opposing parallel but laterally displaced forces exerted on the membrane 29 and

•* spacer 33 by the body end of the probe housing 3, anode 5 and cathode 7, and by the cover ring 35, respectively, cause the membrane 29 and spacer 33 to be drawn to a taut condition in which they occupy a plane substantially conformin to the planar surface defined by the body ends of the probe housing 3, anode 5 and cathode 7. The retension and stretching of the membrane 29 and spacer 3

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^' result in a highly stable configuration obviating the need for reealibration of the probe with time and movement of the patient while the probe is attached as is often required with prior art probes.

A cap member 38 (Figure 3) can be removably connected to the body end of the fixation ring 19 to protect the membrane 29 until it is to be applied to a patient and to prevent a buildup of ion solution adjacent the cathode 7. The cap member 38 has a flange 39 which can be snapped over the outer ridge 25 of the fixation ring housing 19. Inserted in the cap member 38 is a resilient disc 41 which, in the preferred embodiment of the invention, is made from a resilient elastic material such as a spongy foam. The distance from the flange 39 of the cap member to the resilient disc is such that when the cap member is installed on the fixation ring housing 19, the resilient disc 41 urges the mem¬ brane 29 and spacer 33 into a concave configuration when viewed from the body end of the fixation ring by pressing the center of the membrane 29 and spacer 33 toward the probe end of the fixation ring, thereby forcing the ion solution and any entrapped air away from the eenter of the probe, that is, away from the cathode 7 when the fixation ring is attached to the probe housing 3. The ion solution forced away from the eenter of the probe can occupy space within the probe including voids provided beneath the anode 5 and the voids provided between the lesser diameter portion of the probe housing 3 and fixation ring housing 19. The forcing of ion solution away from the center of the probe enhances measurement precision and accuracy and reduces pressure sensitivity by leaving a controlled amount of ion solution absorbed by the spacer 39 adjacent the cathode 7.

It is to be appreciated from the foregoing description that the preferred embodiment of the invention can be altered or modified without departing from the spirit and scope of the invention which is set forth in the following claims.

Claims

WHAT IS CLAIMED IS:

1. A fixation ring for removably mounting on a transcutaneous gas sen sor probe having first and second electrodes adapted to contact an ion solution a membrane for maintaining said solution in engagement with said electrodes and permitting said gas to permeate into said solution comprising said electrod and permitting said gas to permeate into said solution comprising a housing having a bore therethrough, a probe end and a body end, means for removably mounting said fixation ring on said probe with said probe end adjacent said probe, and means for mounting said membrane on said fixation ring proximate said body end and in sealing relationship with said bore so that only matter to which said membrane is permeable can pass through said bore when said fixati ring is attached to said probe.

2. Apparatus according to claim 1 wherein said housing has a first ridg circumscribing said bore and further comprising a ring adapted to be snuggly fitted over said ridge for compressing the periphery of said membrane between said ring and said ridge.

3. Apparatus according to claim 2 further comprising a cover member mounted on said housing and having an aperture in alignment with said bore, there being defined at the inner perimeter of said aperture a bearing surface for tensioning said membrane as said probe is urged against said membrane wh said fixation ring is -attached to said probe.

4. Apparatus according to elaim 1 further^ comprising a cap member removably connected to the body end of said housing, said cap member being adapted to resiliently engage said membrane for urging said membrane into a concave configuration when viewed from the body end of said housing for pres ing the eenter of said membrane toward the probe end of said housing thereby forcing said ion solution and any entrapped air away from center of said probe when said fixation ring is attached to said probe.

5. Apparatus according to claim 4 wherein said cap member comprises layer of a resilient material adapted to be compressed against said membrane when said cap member is -attached to said housing.

6. Apparatus according to claim 5 wherein said resilient material urges said membrane to conform to the profile of the surfaces of said electrodes.

7. In a transcutaneous gas probe for sensing a gas emitted through the skin of a living body including a first housing having a body end and a graspin end, first and second electrodes mounted in said housing, and a membrane im-

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WIPO permeable to an ion forming solution and permeable to the gas to the measured for maintaining said solution in contact with said electrodes and permitting said gas to permeate therethrough and into said solution, the improvement which comprises a second housing having a body end, a probe end, a bore therethrough, means for removably attaching said first housing to said second housing, and means for mounting said membrane on said second housing adjacent the body end thereof in sealing relationship with the bore therein.

8. Apparatus according to claim 7 wherein said attaching means includes threads formed on said second housing, said first housing having complementary threads adapted to engage said second housing threads.

9. Apparatus according to claim 7 wherein said second housing has a ridge circumscribing one end of said bore and said mounting means includes a ring adapted to be fitted over said ridge with a portion of said membrane being held between said ridge and said ring.

10. Apparatus according to claim 9 wherein said ridge includes a wall which tapers radially inwardly in a direction from the body end of said second housing toward the probe end of said second housing, said ring being resiliently expandable so that it can be forced over said ridge and then contracted thereby forming a seal against said ridge.

11. Apparatus according to claim 9 further comprising a cover member having an aperture and mounted on said second housing with said aperture in alignment with said bore for exposing a surface of said membrane.

12. Apparatus according to claim 11 wherein said cover member has one surface in engagement with said membrane and another surface adapted to engage the skin of the body.

13. Apparatus according to claim 12 wherein said one surface exerts a force on said membrane having a component in opposition to a component of the force exerted on said membrane by said first housing when said second housing is attached to said first housing thereby tensioning said membrane for limiting movement of said membrane relative to said electrodes.

14. Apparatus according to claim 13 wherein said membrane engaging surface of said first housing extends beyond said skin engaging surface of said second housing for urging said membrane firmly against the skin when said skin engaging surface of said second housing is held in contact with the skin surface.

15. Apparatus according to claim 14 and further comprising an absorbant spacer element mounted adjacent said membrane for absorbing a controlled

OMPI amount of said ion solution, said spacer element adapted to engage said first and second electrodes.