CA1277848C - Optical catheter calibrating assembly - Google Patents
Optical catheter calibrating assemblyInfo
- Publication number
- CA1277848C CA1277848C CA000521131A CA521131A CA1277848C CA 1277848 C CA1277848 C CA 1277848C CA 000521131 A CA000521131 A CA 000521131A CA 521131 A CA521131 A CA 521131A CA 1277848 C CA1277848 C CA 1277848C
- Authority
- CA
- Canada
- Prior art keywords
- catheter
- enclosure
- distal end
- reference element
- passage
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/47—Scattering, i.e. diffuse reflection
- G01N21/4785—Standardising light scatter apparatus; Standards therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1495—Calibrating or testing of in-vivo probes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/02—Operational features
- A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
- A61B2560/0228—Operational features of calibration, e.g. protocols for calibrating sensors using calibration standards
- A61B2560/0233—Optical standards
Abstract
Abstract of the Disclosure A calibrating device for an optical catheter is provided in order to calibrate the catheter for use in a catheter oximeter system. The calibrating device includes a tube having a reference block therein which is spring-loaded into compliant engagement with the distal end of the catheter carrying the fiberoptic light transmitting and receiving guides. A releasable strap tightly secures the catheter to the calibrating device. The packaged catheter is therefore ready for calibration by simply removing the proximal end thereof from a sealed package while the calibrating device and major length of the catheter remain in their sealed and sterilized condition and connecting it to a processor for performing the calibration operation.
Description
lZ7784~
1 Backqround of the Invention 2 1. Field of the Invention 3 This invention relates to a calibration device and 4 calibrating system for optical catheters used in a catheter oximetry system, and more particularly, it relates to a calib--6 rating device which may remain with the sealed and sterilized 7 distal end of the catheter within a package while the proximal B end of the catheter is plugged into a computer or processor 9 in order to perform the calibrating operation.
2. Description of the Prior Art 11 A catheter oximetry system provides accurate, continu-12 ous, real-time measurement of mixed venous oxygen saturation 13 using multiple wavelength reflection spectrophotometry. The 14 color of red blood cells progressively changes from scarlet to purple as the amount of oxygen the red blood cells are carry-16 ing decreases. When light of different selected wavelengths 17 illuminates the blood, the amount of light backscattered, or 18 reflected, at each wavelength depends upon the color, and 19 therefore, oxygen level of the blood. Careful choice of wave-lengths in the transmittal light allows accurate measurement 21 of oxygenated hemoglobin with minimal interference by other 22 blood characteristics such as temperature, pH, and hematocrit.
23 Approximately 98% of the oxygen in the blood is chemi-24 cally combined with hemoglobin in red blood cells. The absorption of red and infr~red light substantially differs for 26 oxygenated and deoxygenated hemoglobin, and it varies for dif-27 ferent wavelengths of light within this red/infrared spectrum.
28 Therefore, the relative amounts of oxygenated hemoglobin and 29 deoxygenated hemoglobin in the blood can be determined by 3~ measuring the relative absorption of light at different .; i 1 selected wavelengths. The percentage of hemoglobin which is 2 in the oxygenated form is defined as the oxygen saturation of 3 the blood in the equation:
4 Oxygen Saturation = HbO2 x 100 Hb + HbO2 6 where HbO2 is the oxygenated hemoglobin concentration and Hb 7 is the deoxygenated hemoglobin concentration.
6 A widely used catheter oximetry system consists of 9 three basic components: (1) a disposable fiberoptic pulmonary artery catheter that has a distal end adapted to be inserted 11 into a vein of a patient and that interfaces at its other end 12 with (2) an optical module containing light emitting diodes, a 13 photodetector and associated electronics, which in turn, 14 interfaces with the electrical leads of (3) a computer-based instrument that performs all of the data processing and con-16 trol functions with displays, alarms and associated read-out 17 devices. The instrument ~and optical module may be reused many 18 times with different patients, but the catheter is used only 19 with a single patient during a single operation or monitoring process. Thus, the catheters are disposable and are arranged 21 to be separately packaged in sealed aseptic packages each with 22 a specially designed optical connector plug adapted to be 23 plugged into the optical module when the catheter is readv for 24 use.
2~ Since the total amount of light reflected back from the 26 blood under test during the catheter oximetry measurements is 27 relatively low, and since variations in the manufacturing of 28 the optical components (particularly the fiberoptics) create 29 differences in transmission which affect the output readings, it is important that each catheter be separately calibrated 1;~77848 1 immediately before it is used so as to relate the actual light 2 intensities received from the sample under test to the unknown 3 concentrations of the substances being quantified in the ~ sample under test. This may be accomplished by initially - 5 measuring a given sample of blood with the catheter and then 6 wholly independently measuring the same blood in the labora-7 tory by a different techni~ue in order ~o match the laboratory B calculated actual oxygen saturation content with the instru-9 ment calculated content and adjusting the latter accordingly.
Such a technique has the obvious disadvantage, however, that 11 the time required for making the laboratory tests causes an 12 undesirable delay between the time of catheter placement and 13 the time at which the oxygen saturation measurements can be 14 u~ilized with assurance of their correctness. In order to ~15 overcome this obvious disadvantage, various techni~ues have 16 been proposed whereby the catheter is initially calibrated 17 using a reference material such as suspensions of milk of 18 magnesia combined with dyes or filters or various light 19 reflective targets which the distal end of the catheter can be initially directed to and which have known reflectivity 21 characteristics.
22 One method of initial catheter calibration which has 23 found wide acceptance in the field is disclosed in United 24 States patent 4,322,164 to Robert F. Shaw et al. Briefly, 2~ this method involves a reference bloc~ formed as a solid 26 compliant mass having a plurality of light reflective 27 particleæ embedded therein. This reference block is received 28 within an enclosed tube, and, in the initial packaging of the 29 catheter, the distal end thereof is inserted into the tube adjacent to but spaced from the reference block and gripped to 1~7848 1 restrain further movement. The reference block is then spring2 loaded but restrained by a releasable catch so that it can be 3 released into resilient engagement with the end of the 4 catheter at the time that the calibration measurements are - 5 made. Once the calibration readings have been obtained, the 6 catheter can be pulled loose from the tube and reference block 7 and placed in a patient for obtaining blood oxygen saturation 8 measurements in the manner intended. The initial calibration g readings are obtained with the reference block and catheter remaining in the package in a sealed and sterilized condition 11 while the connector plug end of the catheter is connected to 12 the optical module and oximetry processor.
13 While the aforedescribed catheter calibration scheme 14 has met with considerable success, there have been some prob-lems from time to time. Thus, it may be inconvenient for the 16 doctor or nurse to perfcrm the separate operation of releasing 17 the reference block into engagement with the catheter tip, or, 1~ such operation may fail or expose the catheter to possible 19 contamination prior to its actual time of use.
Summary of the Invention 21 With the optical catheter assembly package of the 22 present invention, a catheter having transmitting and 23 receiving light guides therein is arranged to be packaged in a 24 tray with the distal end of the catheter being received in a calibrating device. The calibrating device includes a tubular 26 enclosure within which a reference element is urged into 27 compliant engagement with the distal end of the catheter and 28 w~th means being provided for tiqhtly gripping and holding the 29 catheter to the enclosure so that the catheter and calibrating device are ready for an immediate calibration operati~n in the 1~7848 1 package without any additional movement of either catheter or 2 reference block being required.
3 The package is sealed with a cover material that 4 encloses the catheter and calibrating device in the tray in a sealed and sterile condition. When the catheter is ready for 6 use, a portion of the sealing material can be removed while 7 the remainder is left in its sealed and sterile condition so 8 as to only expose the optical connector at the proximal end of 9 the catheter permitting it to be connected to an oximetry system to provide a calibration reading for the catheter --11 all while the distal end and insertable major length of the 12 catheter remains in a sealed, sterile condition. Upon the 13 conclusion of the calibration process and the recording of the 14 résults within the oximetry system, the remainder of the sealing material can be removed, the calibrating device 16 readily removed from the distal end of the catheter, and the 17 ca~heter placed directly in the patient for continuous blood 18 oxygen saturation readings.
19 Brief DescriPtion of_t~c~ 3g~
-Figure 1 is an isometric view of the calibrating device 21 of the present invention with the distal end of an oximetry 22 catheter being shown inserted and clamped therein.
23 Figure 2 is an enlarged section taken along line 2-2 of 24 Figure 1.
Figure 3 is an enlarged longitudinal section through 26 the calibrating device and catheter of Figure 1.
27 Figures 4-6 are schematic views illustrating the 2~ packaging of the catheter and calibrating device of the 29 present invention and particularly showing the manner in which the calibrating operation is carried out.
~Z77848 1 Description of the Preferred Embodiment 2 The calibrating device 10 of the present invention is 3 shown in Figures 1-3 wherein it will be seen to be comprised 4 of a cylinder 12 which is closed at one end 13 and open at the 5 other end thereof (Fig. 3). Received within the open end of 6 the cylinder 12 is a plug 15 which is provided near the center 7 thereof with a circumferencially extending rib 17 adapted to 8 be received within a detent 18 just within the open end of the g cylinder 12. The plug is inserted in the cylinder during the assembly of the calibrating device, and, as indicated in 11 Figure 3, it is snapped into snug engagement therewith.
12 The distal end of an optical catheter 20 is adapted to 13 be inserted through the plug 15 within an axial passage 22 14 extending therethrough. As seen in Figure 3, the axial 15 passage 22 is just slightly larger than the outer diameter of 16 the catheter and its balloon 21 so as to snugly confine the 17 catheter therewithin. Positioned within the inner end of the 18 tubular member 12 is a reference block 24 and a coil spring 25 19 with the spring urging the reference block into firm engage-20 ment with the flat distal end 20a of the catheter 20 at a posi-21 tion spaced inwardly from the end of the plug 15.
22 The reference block 24 is the same as that shown and 23 described in the aforementioned prior United States Patent No.
24 4,322,164 to Robert ~. Shaw et al. ~riefly, the reference 2~ block comprises a solid cylindrical element ,ormed of a sili-26 cone resin and having a plurality of tiny particles scattered 27 throughout its mass to provide scattering and reflecting 28 surfaces for the light beams transmitted by the catheter 20.
29 The particles will typically have dimensions within the range of from about 0.02 to about 20 microns and should be uniformly dis-1~48 1 persed within the solid mass of the reference block 24. The 2 mass is translucent is nature and has compliant character-3 istics at the surface thereof so that it will yield when 4 pressed against the rigid surface 20a of the catheter thereby ~ insuring a snug fit which will not become easily dislodged -6 during handling of the catheter and attached calibrating 7 device.
8 As shown in Figures 1-3 the catheter 20 comprises a 9 conventional optical catheter useful in oximetry measurements having a pair of separated lumens with a transmitting light 11 guide 28 formed of a single fiber and a receiving light guide 12 29 likewise formed of a single fiber extending side-by-side 13 along the length of the catheter to an exposed position at the 14 flattened surface 20a at the very end of the catheter. Light carried along the transmitting fiber 28 is directed into the 16 reference block 24 where it is backscattered and a portion 17 thereof is reflected back into the receiving fiber 29 for 18 transmission back to the oximetry processing apparatus to 19 provide readings useful for calibrating the catheter and associated optical components.
21 Since it is critical that the ~atheter remain in snug 22 engagement with the compliant reference block from the time 23 that it is initially packaged up until and through the time 24 when the calibr-tion readings are obtained, means are provided ,or insuring that this condition will be maintained. Thus, it 26 will be seen that the outer end of plug 1~ is removed so as to 27 provide a short axially extending section 32 which exposes the 28 longitudinally extending passage 22 through the plug. A pair 29 of prongs 34 are provided at opposed sides of the section 32 of the plug and extend outwardly therefrom. A strap 36 formed 1 of a highly resilient and elastomeric material is stretched 2 between the prongs 34 so as to tightly engage one side of the 3 catheter 20 and force it into tight engagement with the longi-4 tudinally exposed section of the passage 22 wherein it will S remain until the strap is removed. This is accomplished by 6 providing a pair of apertures 38 ~one only being shown in Figure 1) at one end of the strap which apertures are spaced B apart by a distance less than the distance between the prongs 9 34. One aperture is then forced over one of the prongs 34 and the strap is stretched until the other aperture can be 11 received upon the opposed prong 34. Also, as shown, the strap 12 includes an enlarged tab 40 at the outwardly projecting end 13 thereof which tab is of a size whereby it can be readily 14 g~ipped between the fingers in order to pull the strap loose 1~ from the prongs at the conclusion of the calibration operation 16 in order to release the catheter from the calibrating device.
17 The use of the calibrating device 10 of the present 18 invention in a catheter oximetry system is shown sequentially 19 in Figures 4, 5 and 6. With reference to Figure 4, it will be seen that the catheter 20 is arranged to be packaged within 21 conforming recesses set in a rectangularly shaped plastic tray 22 42. A piece of plastic sealing material 44 is laid atop the 23 tray and sealed thereto, and the tray and enclosed catheter 24 are then sterilized using conventional sterilization tech-niques. The di~tal end of the catheter is connected directly 26 to the calibrating device 10 in the aforedescribed manner and 27 clamped thereto by the strap 36 with the tab 40 of the strap 28 extending to the side in a position adapting it to ready 29 removability. The proximal end of the catheter includes the optical connector plug 46 and a plurality of other conven~
1 tional output connections including lumen connections for 2 pressure readings, samplings, or infusion, a thermistor con-3 nection for cardiac outputs and a mechanism connected to pres-4 surize the balloon 21 at the tip of the catheter -- all of such - 5 elements being conventional with the details thereof having no 6 relevance with respect to the present invention.
7 As shown in Figure 5, the first step in the calibration ~ operation is to remove the plastic sealing material 44 from g atop the tray to allow the fiberoptic connector plug 46 to be removed and coupled to the computer or processor 48. As can ~1 be seen, however, the sealing material 44 is provided with two 12 sections separated by a seam or scoreline 43 whereby only one 13 portion thereof is removed during the initial peeling of the 14 material, as shown in Figure 5, exposing only the proximal end of the catheter and the connections thereto (including the 16 connector plug 46) but leaving the main body of the catheter, 17 which will later be placed in the patient, within the package 18 in its original sealed and sterilized condition. The connec-19 tor plug can then be placed in a receptacle in an optical module 50 which provides the electro-optical coupling between 21 the connector plug 44 and the processing circuitry of the 22 computer 48. When this is accomplished, the compu'er is 23 turned on to provide signals to the optical module ~0 creating 24 the light sources which are directed via the cou?ling 46 down the length of the catheter to the reference block 24 wherein 26 the light is backscattered and reflected back to the ~ptical 27 module. The dule then converts these light signals int~
2B electrical signals for processing by the computer. In this 29 way the appropriate calibration readings are obtained and stored in the computer.
_g_ ~ Once the relevant calibration readings have been 2 obtained the catheter is calibrated and immediately ready for 3 use in monitoring the blood oxygenation of a patient. As ~ shown in Figure 6, the remainder of the sealing material 44 is 5 then removed, and a simple pulling away of the strap 36 from 6 its secured position on the calibrating device 10 leaves the 7 catheter 20 free from its locked engagement therewith. The 8 nurse ~r doctor can then directly take the catheter and place g it in the patient.
It will be seen that the calibrating device of the 11 present invention permits the catheter to be directly locked 12 to a calibrating device and packaged in such manner so that no 13 additional steps are required other than to connect the proxi-14 mal end of the catheter to suitable processing circuitry in 15 order to obtain appropriate calibration readings. Once the 16 readings have been obtained, the catheter is ready for 1~ immediate use, and the protective and sealing material can be 18 removed to permit the catheter to be immediately used. It has 19 been found that the packàging method as aforedescribed will 20 stand up under repeated jostling or dropping without dis-21 lodging the reference block from the catheter.
22 Although the best mode contemplated for carrying out 23 the present invention has been herein shown and described, it 24 will be apparent that ~odification and variation can be made -2~ without departing fro~ what is re~arded to be the subject 2~ matter of the invention.
1 Backqround of the Invention 2 1. Field of the Invention 3 This invention relates to a calibration device and 4 calibrating system for optical catheters used in a catheter oximetry system, and more particularly, it relates to a calib--6 rating device which may remain with the sealed and sterilized 7 distal end of the catheter within a package while the proximal B end of the catheter is plugged into a computer or processor 9 in order to perform the calibrating operation.
2. Description of the Prior Art 11 A catheter oximetry system provides accurate, continu-12 ous, real-time measurement of mixed venous oxygen saturation 13 using multiple wavelength reflection spectrophotometry. The 14 color of red blood cells progressively changes from scarlet to purple as the amount of oxygen the red blood cells are carry-16 ing decreases. When light of different selected wavelengths 17 illuminates the blood, the amount of light backscattered, or 18 reflected, at each wavelength depends upon the color, and 19 therefore, oxygen level of the blood. Careful choice of wave-lengths in the transmittal light allows accurate measurement 21 of oxygenated hemoglobin with minimal interference by other 22 blood characteristics such as temperature, pH, and hematocrit.
23 Approximately 98% of the oxygen in the blood is chemi-24 cally combined with hemoglobin in red blood cells. The absorption of red and infr~red light substantially differs for 26 oxygenated and deoxygenated hemoglobin, and it varies for dif-27 ferent wavelengths of light within this red/infrared spectrum.
28 Therefore, the relative amounts of oxygenated hemoglobin and 29 deoxygenated hemoglobin in the blood can be determined by 3~ measuring the relative absorption of light at different .; i 1 selected wavelengths. The percentage of hemoglobin which is 2 in the oxygenated form is defined as the oxygen saturation of 3 the blood in the equation:
4 Oxygen Saturation = HbO2 x 100 Hb + HbO2 6 where HbO2 is the oxygenated hemoglobin concentration and Hb 7 is the deoxygenated hemoglobin concentration.
6 A widely used catheter oximetry system consists of 9 three basic components: (1) a disposable fiberoptic pulmonary artery catheter that has a distal end adapted to be inserted 11 into a vein of a patient and that interfaces at its other end 12 with (2) an optical module containing light emitting diodes, a 13 photodetector and associated electronics, which in turn, 14 interfaces with the electrical leads of (3) a computer-based instrument that performs all of the data processing and con-16 trol functions with displays, alarms and associated read-out 17 devices. The instrument ~and optical module may be reused many 18 times with different patients, but the catheter is used only 19 with a single patient during a single operation or monitoring process. Thus, the catheters are disposable and are arranged 21 to be separately packaged in sealed aseptic packages each with 22 a specially designed optical connector plug adapted to be 23 plugged into the optical module when the catheter is readv for 24 use.
2~ Since the total amount of light reflected back from the 26 blood under test during the catheter oximetry measurements is 27 relatively low, and since variations in the manufacturing of 28 the optical components (particularly the fiberoptics) create 29 differences in transmission which affect the output readings, it is important that each catheter be separately calibrated 1;~77848 1 immediately before it is used so as to relate the actual light 2 intensities received from the sample under test to the unknown 3 concentrations of the substances being quantified in the ~ sample under test. This may be accomplished by initially - 5 measuring a given sample of blood with the catheter and then 6 wholly independently measuring the same blood in the labora-7 tory by a different techni~ue in order ~o match the laboratory B calculated actual oxygen saturation content with the instru-9 ment calculated content and adjusting the latter accordingly.
Such a technique has the obvious disadvantage, however, that 11 the time required for making the laboratory tests causes an 12 undesirable delay between the time of catheter placement and 13 the time at which the oxygen saturation measurements can be 14 u~ilized with assurance of their correctness. In order to ~15 overcome this obvious disadvantage, various techni~ues have 16 been proposed whereby the catheter is initially calibrated 17 using a reference material such as suspensions of milk of 18 magnesia combined with dyes or filters or various light 19 reflective targets which the distal end of the catheter can be initially directed to and which have known reflectivity 21 characteristics.
22 One method of initial catheter calibration which has 23 found wide acceptance in the field is disclosed in United 24 States patent 4,322,164 to Robert F. Shaw et al. Briefly, 2~ this method involves a reference bloc~ formed as a solid 26 compliant mass having a plurality of light reflective 27 particleæ embedded therein. This reference block is received 28 within an enclosed tube, and, in the initial packaging of the 29 catheter, the distal end thereof is inserted into the tube adjacent to but spaced from the reference block and gripped to 1~7848 1 restrain further movement. The reference block is then spring2 loaded but restrained by a releasable catch so that it can be 3 released into resilient engagement with the end of the 4 catheter at the time that the calibration measurements are - 5 made. Once the calibration readings have been obtained, the 6 catheter can be pulled loose from the tube and reference block 7 and placed in a patient for obtaining blood oxygen saturation 8 measurements in the manner intended. The initial calibration g readings are obtained with the reference block and catheter remaining in the package in a sealed and sterilized condition 11 while the connector plug end of the catheter is connected to 12 the optical module and oximetry processor.
13 While the aforedescribed catheter calibration scheme 14 has met with considerable success, there have been some prob-lems from time to time. Thus, it may be inconvenient for the 16 doctor or nurse to perfcrm the separate operation of releasing 17 the reference block into engagement with the catheter tip, or, 1~ such operation may fail or expose the catheter to possible 19 contamination prior to its actual time of use.
Summary of the Invention 21 With the optical catheter assembly package of the 22 present invention, a catheter having transmitting and 23 receiving light guides therein is arranged to be packaged in a 24 tray with the distal end of the catheter being received in a calibrating device. The calibrating device includes a tubular 26 enclosure within which a reference element is urged into 27 compliant engagement with the distal end of the catheter and 28 w~th means being provided for tiqhtly gripping and holding the 29 catheter to the enclosure so that the catheter and calibrating device are ready for an immediate calibration operati~n in the 1~7848 1 package without any additional movement of either catheter or 2 reference block being required.
3 The package is sealed with a cover material that 4 encloses the catheter and calibrating device in the tray in a sealed and sterile condition. When the catheter is ready for 6 use, a portion of the sealing material can be removed while 7 the remainder is left in its sealed and sterile condition so 8 as to only expose the optical connector at the proximal end of 9 the catheter permitting it to be connected to an oximetry system to provide a calibration reading for the catheter --11 all while the distal end and insertable major length of the 12 catheter remains in a sealed, sterile condition. Upon the 13 conclusion of the calibration process and the recording of the 14 résults within the oximetry system, the remainder of the sealing material can be removed, the calibrating device 16 readily removed from the distal end of the catheter, and the 17 ca~heter placed directly in the patient for continuous blood 18 oxygen saturation readings.
19 Brief DescriPtion of_t~c~ 3g~
-Figure 1 is an isometric view of the calibrating device 21 of the present invention with the distal end of an oximetry 22 catheter being shown inserted and clamped therein.
23 Figure 2 is an enlarged section taken along line 2-2 of 24 Figure 1.
Figure 3 is an enlarged longitudinal section through 26 the calibrating device and catheter of Figure 1.
27 Figures 4-6 are schematic views illustrating the 2~ packaging of the catheter and calibrating device of the 29 present invention and particularly showing the manner in which the calibrating operation is carried out.
~Z77848 1 Description of the Preferred Embodiment 2 The calibrating device 10 of the present invention is 3 shown in Figures 1-3 wherein it will be seen to be comprised 4 of a cylinder 12 which is closed at one end 13 and open at the 5 other end thereof (Fig. 3). Received within the open end of 6 the cylinder 12 is a plug 15 which is provided near the center 7 thereof with a circumferencially extending rib 17 adapted to 8 be received within a detent 18 just within the open end of the g cylinder 12. The plug is inserted in the cylinder during the assembly of the calibrating device, and, as indicated in 11 Figure 3, it is snapped into snug engagement therewith.
12 The distal end of an optical catheter 20 is adapted to 13 be inserted through the plug 15 within an axial passage 22 14 extending therethrough. As seen in Figure 3, the axial 15 passage 22 is just slightly larger than the outer diameter of 16 the catheter and its balloon 21 so as to snugly confine the 17 catheter therewithin. Positioned within the inner end of the 18 tubular member 12 is a reference block 24 and a coil spring 25 19 with the spring urging the reference block into firm engage-20 ment with the flat distal end 20a of the catheter 20 at a posi-21 tion spaced inwardly from the end of the plug 15.
22 The reference block 24 is the same as that shown and 23 described in the aforementioned prior United States Patent No.
24 4,322,164 to Robert ~. Shaw et al. ~riefly, the reference 2~ block comprises a solid cylindrical element ,ormed of a sili-26 cone resin and having a plurality of tiny particles scattered 27 throughout its mass to provide scattering and reflecting 28 surfaces for the light beams transmitted by the catheter 20.
29 The particles will typically have dimensions within the range of from about 0.02 to about 20 microns and should be uniformly dis-1~48 1 persed within the solid mass of the reference block 24. The 2 mass is translucent is nature and has compliant character-3 istics at the surface thereof so that it will yield when 4 pressed against the rigid surface 20a of the catheter thereby ~ insuring a snug fit which will not become easily dislodged -6 during handling of the catheter and attached calibrating 7 device.
8 As shown in Figures 1-3 the catheter 20 comprises a 9 conventional optical catheter useful in oximetry measurements having a pair of separated lumens with a transmitting light 11 guide 28 formed of a single fiber and a receiving light guide 12 29 likewise formed of a single fiber extending side-by-side 13 along the length of the catheter to an exposed position at the 14 flattened surface 20a at the very end of the catheter. Light carried along the transmitting fiber 28 is directed into the 16 reference block 24 where it is backscattered and a portion 17 thereof is reflected back into the receiving fiber 29 for 18 transmission back to the oximetry processing apparatus to 19 provide readings useful for calibrating the catheter and associated optical components.
21 Since it is critical that the ~atheter remain in snug 22 engagement with the compliant reference block from the time 23 that it is initially packaged up until and through the time 24 when the calibr-tion readings are obtained, means are provided ,or insuring that this condition will be maintained. Thus, it 26 will be seen that the outer end of plug 1~ is removed so as to 27 provide a short axially extending section 32 which exposes the 28 longitudinally extending passage 22 through the plug. A pair 29 of prongs 34 are provided at opposed sides of the section 32 of the plug and extend outwardly therefrom. A strap 36 formed 1 of a highly resilient and elastomeric material is stretched 2 between the prongs 34 so as to tightly engage one side of the 3 catheter 20 and force it into tight engagement with the longi-4 tudinally exposed section of the passage 22 wherein it will S remain until the strap is removed. This is accomplished by 6 providing a pair of apertures 38 ~one only being shown in Figure 1) at one end of the strap which apertures are spaced B apart by a distance less than the distance between the prongs 9 34. One aperture is then forced over one of the prongs 34 and the strap is stretched until the other aperture can be 11 received upon the opposed prong 34. Also, as shown, the strap 12 includes an enlarged tab 40 at the outwardly projecting end 13 thereof which tab is of a size whereby it can be readily 14 g~ipped between the fingers in order to pull the strap loose 1~ from the prongs at the conclusion of the calibration operation 16 in order to release the catheter from the calibrating device.
17 The use of the calibrating device 10 of the present 18 invention in a catheter oximetry system is shown sequentially 19 in Figures 4, 5 and 6. With reference to Figure 4, it will be seen that the catheter 20 is arranged to be packaged within 21 conforming recesses set in a rectangularly shaped plastic tray 22 42. A piece of plastic sealing material 44 is laid atop the 23 tray and sealed thereto, and the tray and enclosed catheter 24 are then sterilized using conventional sterilization tech-niques. The di~tal end of the catheter is connected directly 26 to the calibrating device 10 in the aforedescribed manner and 27 clamped thereto by the strap 36 with the tab 40 of the strap 28 extending to the side in a position adapting it to ready 29 removability. The proximal end of the catheter includes the optical connector plug 46 and a plurality of other conven~
1 tional output connections including lumen connections for 2 pressure readings, samplings, or infusion, a thermistor con-3 nection for cardiac outputs and a mechanism connected to pres-4 surize the balloon 21 at the tip of the catheter -- all of such - 5 elements being conventional with the details thereof having no 6 relevance with respect to the present invention.
7 As shown in Figure 5, the first step in the calibration ~ operation is to remove the plastic sealing material 44 from g atop the tray to allow the fiberoptic connector plug 46 to be removed and coupled to the computer or processor 48. As can ~1 be seen, however, the sealing material 44 is provided with two 12 sections separated by a seam or scoreline 43 whereby only one 13 portion thereof is removed during the initial peeling of the 14 material, as shown in Figure 5, exposing only the proximal end of the catheter and the connections thereto (including the 16 connector plug 46) but leaving the main body of the catheter, 17 which will later be placed in the patient, within the package 18 in its original sealed and sterilized condition. The connec-19 tor plug can then be placed in a receptacle in an optical module 50 which provides the electro-optical coupling between 21 the connector plug 44 and the processing circuitry of the 22 computer 48. When this is accomplished, the compu'er is 23 turned on to provide signals to the optical module ~0 creating 24 the light sources which are directed via the cou?ling 46 down the length of the catheter to the reference block 24 wherein 26 the light is backscattered and reflected back to the ~ptical 27 module. The dule then converts these light signals int~
2B electrical signals for processing by the computer. In this 29 way the appropriate calibration readings are obtained and stored in the computer.
_g_ ~ Once the relevant calibration readings have been 2 obtained the catheter is calibrated and immediately ready for 3 use in monitoring the blood oxygenation of a patient. As ~ shown in Figure 6, the remainder of the sealing material 44 is 5 then removed, and a simple pulling away of the strap 36 from 6 its secured position on the calibrating device 10 leaves the 7 catheter 20 free from its locked engagement therewith. The 8 nurse ~r doctor can then directly take the catheter and place g it in the patient.
It will be seen that the calibrating device of the 11 present invention permits the catheter to be directly locked 12 to a calibrating device and packaged in such manner so that no 13 additional steps are required other than to connect the proxi-14 mal end of the catheter to suitable processing circuitry in 15 order to obtain appropriate calibration readings. Once the 16 readings have been obtained, the catheter is ready for 1~ immediate use, and the protective and sealing material can be 18 removed to permit the catheter to be immediately used. It has 19 been found that the packàging method as aforedescribed will 20 stand up under repeated jostling or dropping without dis-21 lodging the reference block from the catheter.
22 Although the best mode contemplated for carrying out 23 the present invention has been herein shown and described, it 24 will be apparent that ~odification and variation can be made -2~ without departing fro~ what is re~arded to be the subject 2~ matter of the invention.
Claims (10)
1. A calibrating device for use with an optical oximetry catheter comprising a tubular enclosure having a passage therein for reception of the distal end of the catheter, a solid reference element for receiving a light beam from a transmitting light guide in said catheter and for scattering and reflecting light back to a receiving light guide in said catheter in a manner similar to that of blood, said reference element being received within the passage in said enclosure and having a compliant surface characteristic, means for urging said reference element into compliant engagement with the distal end of said catheter, and a resilient strap stretched across the entrance of said passage and removably fastened to the enclosure so as to provide a gripping force on said catheter to prevent movement thereof with respect to the enclosure.
2. A calibrating device according to Claim 1 wherein said tubular enclosure is comprised of a tubular member having a closed end and an open end and a plug received within the open end of the tubular member, said reference element and said means for urging being received within the tubular member, said plug having a narrow axial passage therethrough for receiving the catheter in close confining engagement, the reference element being urged into engagement with the end of the catheter at a position spaced from the inner end of the plug within the tubular member.
3. A calibrating devide according to Claim 2 wherein said axial passage in the plug is longitudinally exposed for a short distance at the outer end of the plug positioned outside of said tubular member, said strap being releasably mounted upon said plug within the longitudinally exposed axial passage section thereof so as to clamp the catheter to the plug.
4. A calibrating devide according to Claim 3 including a pair of prongs extending laterally at opposed sides of the longitudinally exposed axial passage section of the plug, said strap having a pair of spaced apertures adapted to be received by said prongs when the strap is stretched therebetween to clamp the catheter to the plug.
5. An optical catheter assembly ready for use in a catheter oximetry system, said assembly comprising an optical catheter having at least a pair of light guides therein extending to the distal end thereof with one of said guides adapted to transmit light to the distal end of the catheter and with the other of said guides adapted to receive light reflected back from the material at said distal end, and a calibrating device attached to said distal end of the catheter for providing an ititial calibration reading for the catheter, said calibrating device comprising a tubular enclosure having a passage therein for reception of the distal end of the catheter, a solid reference element for receiving a light beam from the transmitting light guide in said catheter and for scattering and reflecting light back to the receiving light guide in said catheter in a manner similar to that of blood, said reference element being received within the passage in said enclosure and having a compliant surface characteristic, means for urging said reference element into compliant engagement with the distal end of said catheter, and a resilient strap stretched across the entrance of said passage and removably fastened to the enclosure so as to provide a gripping force on said catheter to prevent movement thereof with respect to the enclosure and reference element therein.
6. An optical catheter assembly according to Claim 5 wherein said passage in the tubular enclosure is relatively narrow at the end of the passage in which the catheter is inserted for close confinement of the catheter and wherein said passage is relatively wide in the inner portion of the tubular enclosure for securing said reference element.
7. An optical catheter assembly according to Claim 6 wherein said axial passage is longitudinally exposed for a short distance at the outer end of the tubular enclosure, said strap being releasably mounted upon the longitudinally exposed axial passage section of the enclosure so as to clamp the catheter thereto.
8. An optical catheter assembly according to Claim 5 including a pair of prongs extending laterally at opposed sides of the entrance of the enclosure, said strap having a pair of spaced apertures adapted to be received by said prongs when the strap is stretched therebetween to clamp the catheter to the enclosure.
9. An optical catheter assembly package providing a sealed and sterilized catheter ready for use in a catheter oximetry system, said package comprising a tray; an optical catheter having at least a pair of light guides therein extending from an optical connector at one end thereof throughout the length of the catheter to the distal end thereof with one of said guides adapted to transmit light to the distal end of the catheter and with the other of said guides adapted to receive light reflected back from the material at said distal end, said catheter being received in said tray; a calibrating device attached to said distal end of the catheter for providing an initial calibration reading for the catheter, said calibrating device comprising a tubular enclosure having a passage therein for reception of the distal end of the catheter, a solid reference element for receiving a light beam from the transmitting light guide in said catheter and for scattering and reflecting light back to the receiving light guide in said catheter in a manner similar to that of blood, said reference element being received within the passage in said enclosure and having a compliant surface characteristic, means for urging said reference element into compliant engagement with the distal end of said catheter, and means removably fastened to the enclosure for providing a gripping force on said catheter to prevent movement thereof with respect to the enclosure and reference element therein; and a flexible sealing material covering and enclosing the catheter and calibrating device in the tray in a sealed and sterile condition, a portion of said sealing material being removable while the remainder of the sealing material remains in its sealed and enclosing condition to expose the optical connector of the catheter thereby permitting it to be connected to an oximetry system to provide a calibration reading for the catheter based on the reflected light received from the reference element.
10. An optical catheter assembly package according to Claim 9 including a pair of prongs extending laterally at opposed sides of the entrance of the enclosure, said means for providing a gripping force comprising a strap having a pair of spaced apertures adapted to be received by said prongs when the strap is stretched therebetween to clamp the catheter to the enclosure.
2433j
2433j
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US06/791,706 US4650327A (en) | 1985-10-28 | 1985-10-28 | Optical catheter calibrating assembly |
| US791,706 | 1985-10-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1277848C true CA1277848C (en) | 1990-12-18 |
Family
ID=25154545
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000521131A Expired - Fee Related CA1277848C (en) | 1985-10-28 | 1986-10-22 | Optical catheter calibrating assembly |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US4650327A (en) |
| EP (1) | EP0220534B1 (en) |
| JP (1) | JPH0667382B2 (en) |
| CA (1) | CA1277848C (en) |
| DE (1) | DE3679369D1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4322164A (en) * | 1976-10-18 | 1982-03-30 | Oximetrix, Inc. | Sterilizable, disposable optical scattering reference medium and container assembly |
| CA1094341A (en) * | 1976-10-18 | 1981-01-27 | Robert F. Shaw | Sterilizable, disposable optical scattering reference medium |
| US4416285A (en) * | 1978-11-29 | 1983-11-22 | Oximetrix, Inc. | Improved optical catheter and method for making same |
-
1985
- 1985-10-28 US US06/791,706 patent/US4650327A/en not_active Expired - Lifetime
-
1986
- 1986-10-03 EP EP86113656A patent/EP0220534B1/en not_active Expired
- 1986-10-03 DE DE8686113656T patent/DE3679369D1/en not_active Expired - Fee Related
- 1986-10-22 CA CA000521131A patent/CA1277848C/en not_active Expired - Fee Related
- 1986-10-28 JP JP61254828A patent/JPH0667382B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP0220534B1 (en) | 1991-05-22 |
| US4650327A (en) | 1987-03-17 |
| EP0220534A3 (en) | 1987-12-09 |
| DE3679369D1 (en) | 1991-06-27 |
| EP0220534A2 (en) | 1987-05-06 |
| JPS62102737A (en) | 1987-05-13 |
| JPH0667382B2 (en) | 1994-08-31 |
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