Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 10/870,288, filed Jun. 16, 2004, now U.S. Pat. No. 7,190,984 which is a continuation of U.S. application Ser. No. 10/194,156, filed Jul. 12, 2002, now U.S. Pat. No. 6,763,255 which is a divisional of U.S. application Ser. No. 09/750,670, filed Dec. 28, 2000, now U.S. Pat. No. 6,430,423, which is a divisional of U.S. application Ser. No. 09/085,698, filed May 27, 1998, now U.S. Pat. No. 6,173,196, which is a continuation of U.S. application Ser. No. 08/611,151, filed Mar. 5, 1996, now U.S. Pat. No. 5,797,841, the disclosures of which are incorporated by reference herein. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to pulse oximeter sensors, and in particular to methods and apparatus for preventing the shunting of light between the emitter and detector without passing through blood-perfused tissue. 
     Pulse oximetry is typically used to measure various blood flow characteristics including, but not limited to, the blood-oxygen saturation of hemoglobin in arterial blood, the volume of individual blood pulsations supplying the tissue, and the rate of blood pulsations corresponding to each heartbeat of a patient. Measurement of these characteristics has been accomplished by use of a nor-invasive sensor which scatters light through a portion of the patient&#39;s tissue where blood perfuses the tissue, and photoelectrically senses the absorption of light in such tissue. The amount of light absorbed is then used to calculate the amount of blood constituent being measured. 
     The light scattered through the tissue is selected to be of one or more wavelengths that are absorbed by the blood in an amount representative of the amount of the blood constituent present in the blood. The amount of transmitted light scattered through the tissue will vary in accordance with the changing amount of blood constituent in the tissue and the related light absorption. For measuring blood oxygen level, such sensors have typically been provided with a light source that is adapted to generate light of at least two different wavelengths, and with photodetectors sensitive to both of those wavelengths, in accordance with known techniques for measuring blood oxygen saturation. 
     Known non-invasive sensors include devices that are secured to a portion of the body, such as a finger, an ear or the scalp. In animals and humans, the tissue of these body portions is perfused with blood and the tissue surface is readily accessible to the sensor. 
     One problem with such sensors is the detection of ambient light by the photodetector, which can distort the signal. Another problem is the shunting of light directly from the photo-emitter to the photodetector without passing through blood-perfused tissue.  FIG. 1  illustrates two different types of light shunting that can interfere with proper detection of oxygen saturation levels. As shown in  FIG. 1 , a sensor  10  is wrapped around the tip of a finger  12 . The sensor includes a light emitter  14  and a light detector  16 . Preferably, light from emitter  14  passes through finger  12  to be detected at detector  16 , except for amounts absorbed by the blood-perfused tissue. 
     A first type of shunting, referred to as type  1  shunting, is shunting inside the sensor body as illustrated by light path  18 , shown as a wavy line in  FIG. 1 . Light shunts through the sensor body with the sensor body acting like a light guide or light pipe, directing light from the emitter to the detector. 
     A second type of shunting, referred to as type  2  shunting, is illustrated by line  20  in  FIG. 1 . This type of light exits the sensor itself, but reaches the detector without passing through the finger. In the embodiment shown, the light can go around the side of the finger, perhaps by being piped by the sensor body to the edges of the sensor and then jumping through the air gap between the two edges which are wrapped around the side of the finger. 
     The problem of light shunting can be exacerbated by layers placed over the emitter and detector. Often, it is desirable not to have the emitter and detector in direct contact with the patient&#39;s skin because motion artifacts can be reduced by placing a thin layer of adhesive between these components and the skin. Thus, the emitter and detector are typically covered with a clear layer which isolates them from the patient, but allows light to transmit through. The feature of allowing light to transmit through the layer also provides the capability for the clear layer to provide a wave guide effect to shunt light around the finger to the detector. 
     Such layers covering the emitter and detector can be originally included in the sensor, or can be added during a reinforcing or modifying procedure, or during a remanufacture of the sensor. In a remanufacture of a sensor, a sensor which has been used may have its outer, adhesive transparent layer removed. Such a layer is shown in  FIG. 2  as a transparent layer  22  over a sensor  10 . Layer  22  is an adhesive, transparent layer placed over a substrate layer  24 , upon which emitter  14  and detector  16  are mounted, along with any other associated electronics. Layer  22  thus serves both to protect the emitter and detector from the patient, and to adhere the sensor to the patient. During remanufacture, this layer can be stripped off, and a new layer placed thereon. 
     Alternately, layer  22  may be left in place. Such a sensor, with an adhesive outer layer, may be a disposable sensor, since it would not be desirable to have the same adhesive used from one patient to another, and an adhesive is difficult to clean without removing the adhesive. Accordingly, a modification of such a sensor may involve laminating sensor  10  to cover over the adhesive, by adding an additional lamination layer  23  (shown partially broken away) over layer  22 . The lamination layer is itself another layer for shunting light undesirably from the emitter to the detector. Once laminated, in one method, the sensor is then placed into a pocket  26  of a sheath  32 . Sheath  32  includes a transparent cover  28  on an adhesive layer  30 . Layer  30  is adhesive for attaching to a patient. Layer  28  may also optionally be adhesive-coated on the side which faces the patient. Such a modified sensor can be reused by using a new sheath  32 . Transparent layer  28  forms yet another shunting path for the light. 
     A commercially available remanufactured sensor, similar in design to the sensor of  FIG. 2 , is available from Medical Taping Systems, Inc. Another example of a sheath or sleeve for a sensor is shown in U.S. Pat. No. 4,090,410, assigned to Datascope Investment Corp. 
     In addition, when a sheath such as  32  is folded over the end of a patient&#39;s finger, it has a tendency to form wrinkles, with small air gaps in-between the wrinkled portions. The air gaps can actually exacerbate the shunting problem, with light jumping more easily through the air gaps from one portion of the transparent layer to another. 
     Other types of sensors have not used a solid transparent layer  22  as shown in  FIG. 2 . For instance, the Nellcor Puritan Bennett R-15 Oxisensor® and N-25 Neonatal/Adult Oxisensor products use a white-colored substrate with separate transparent strips placed over the emitter and detector (such as strips  11  and  13  illustrated in  FIG. 1 ). The transparent strips are adhesive for adhering to the patient. Since two strips are used, an air gap (gap  15  in  FIG. 1 ) occurs between the transparent layers. As noted above, light can jump such an air gap, and thus a gap by itself may not eliminate all shunting problems. The use of a dark-colored substrate may reduce the amount of shunting, if the selected color is opaque to the wavelengths of interest from the emitter, 650 nm red and 905 nm infrared in a typical implementation. However, the white substrate typically used in the R-15 and N-25 sensors is substantially translucent and thus has limited light blocking qualities. 
     It has been found that shunted light can significantly affect the accuracy of oxygen saturation readings using a pulse oximeter. Accordingly, there is a need to develop a barrier to such light to improve the accuracy of pulse oximeter sensors. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention provides a sensor having an emitter(s) and a detector, with a layer having a first portion over the emitter and a second portion over the detector. A shunt barrier is included between the first and second portions of the overlying layer to substantially block transmission of radiation of the wavelengths emitted by the emitter(s). Preferably, the shunt barrier reduces the radiation shunted to less than 10% of the total radiation detected, and more preferably to less than 1% of the total radiation detected, when the sensor is used on patients having the most opaque tissue of all patients in the target population. 
     In particular for a remanufactured or reinforced or modified sensor, the barrier is added in at least one, and more preferably in all, of the extra layers added or replaced during the remanufacturing, reinforcing or modifying process. The barrier of the present invention may take a number of specific forms. In one embodiment, a woven or fiber material is included between the emitter and detector. In another embodiment, the layer in-between the emitter and detector is pigmented with a color which is substantially opaque for the wavelengths of interest, while the portion above the emitter and detector is substantially transparent. In another embodiment, the entire layer is partially opaque, but is thin enough so that light transmitted through is able to penetrate the partially opaque layer, while light traveling the length of the layer would have a greater distance to travel and would be substantially absorbed. 
     Another shunt barrier is the insertion of perforations in the layer between the emitter and detector. The perforations may provide air gaps, which still will shunt some light, or may be filled with other material or have the insides of the perforations colored with an opaque color. 
     In another embodiment, the layer between the emitter and detector is made very thin, such as by embossing, welding or heat sealing. The thinness of the material will limit its effectiveness as a light pipe in the wavelengths of interest, red and infrared. 
     In another embodiment, a deformable, opaque material, such as foam, is included between the emitter and detector, to be compressed upon application to a finger or other body part and fill any gap that might otherwise form through wrinkles or otherwise upon application of the sensor. 
     In another embodiment, an adhesive is applied in a gap between two layers over the emitter and detector, to cause an underlying layer to come in contact with the patient, thus filling the air gap and preventing shunting along that path. 
     While most of the illustrative examples given in this specification are shown as sensors adapted to be wrapped onto a digit, so that light is transmitted through the digit, it will be clear to those skilled in the art that the design principles illustrated may be applied to any “transmittance” or “reflectance” sensors for pulse oximetry. A typical reflectance sensor is the Nellcor Puritan Bennett RS-10. 
     For a further understanding of the nature and advantages of the invention, reference should be made to the following description taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a diagram illustrating the shunting that occurs upon the placement of a sensor over a finger; 
         FIG. 2  is a diagram of a sensor being placed within a reusable sheath in a sensor modification operation; 
         FIGS. 3A and 3B  are diagrams of one embodiment of a shunt barrier showing an opaque film abutting both an air gap and another layer; 
         FIG. 4  is a diagram of a sensor with a woven or fiber material for a shunt barrier; 
         FIG. 5  is a diagram of a sensor with a partially opaque material for a shunt barrier, with a trade-off between transmission intensity and preventing shunting; 
         FIG. 6  is a diagram of a sensor using perforations as a shunt barrier; 
         FIG. 7  is a diagram of a sensor with a thinned layer between emitter and detector as a shunt barrier; 
         FIG. 8  is a diagram of a sensor using differential coloring as a shunt barrier; 
         FIG. 9  is a diagram of a sensor using an adhesive in a gap between layers over the emitter and detector for a shunt barrier; 
         FIG. 10  is a diagram of a sensor using a foam pad between the emitter and detector as a shunt barrier; 
         FIG. 11  is a diagram of a sensor using a solid barrier as a shunt barrier; 
         FIG. 12  is a diagram of a sensor showing the use of overlapping layers as a shunt barrier; 
         FIG. 13  is a diagram of a sensor using a barrier of metal traces forming a tortuous path between emitter and detector as a shunt barrier; and 
         FIG. 14  is a diagram of a sheath incorporating a colored ring around the emitter and detector windows as a shunt barrier. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIGS. 3A and 3B  illustrate the use of an opaque film adjacent another layer or an air gap to absorb shunting light.  FIG. 3A  shows the opaque film  34 , before assembly being placed over layers  36 ,  36 ′ separated by an air gap  38 . Layers  36 ,  36 ′ may be mounted on a common substrate (not shown). Holes  40  and  42  are shown for the emitter and detector. Alternately, these can be windows or simply a solid portion of a transparent layer.  FIG. 3B  shows the assembled lower layer and opaque film layer  34 . As light attempts to shunt from emitter area  40  to detector area  42 , either passing through the air gap  38  or through layers  36  and  36 ′, it will bounce back and forth between the boundaries of the layer and through the air gap. Some of the light that would normally hit the top end of layer  36  or  36 ′ and bounce back into the middle of the layer, will instead pass into and be absorbed by opaque layer  34 , which is tightly coupled to the layers  36  and  36 ′. 
       FIG. 4  illustrates the use of a woven or fiber material  44  on layers  36  and  36 ′, and filling the air gap  38  of  FIG. 3A . Fibers in the material will absorb light, thus attenuating light attempting to shunt from emitter area  40  to detector area  42 . An additional cover layer  46  may be placed over the assembly, and which will need to be at least partially transparent for light to escape and be detected. Layer  46  can function as another shunting layer. By abutting up against the woven or fiber material  44 , light will be absorbed out of that layer in the same manner as the opaque film  34  of  FIGS. 3A  and B. Alternately, the fiber and woven material can be inserted into layer  46  between the emitter and detector. 
       FIG. 5  shows an alternate embodiment in which a layer  50  is used with an emitter  52  placed on top of it. Alternately, layer  50  could have holes  54  and  56  over the emitter and detector, with the emitter  52  being placed through hole  54  onto an underlying layer. A partially opaque layer  58  is placed above emitter  52  in the embodiment shown. Layer  58  may extend a portion of the way or all of the way over to where the detector is. The opacity of layer  58  is chosen in conjunction with its thickness to allow transmission of substantially all of the light from emitter  52  through the layer, while substantially reducing the amount of light shunted in a path transverse through the layer from the emitter to the detector. Layer  58  preferably attenuates the shunted light so that it is less than 10%, and more preferably less than 1% of the total light received by the detector. Additionally, of the light detected by the detector and converted into electrical signal, the portion of the electrical signal due to shunted light is preferably less than 10% and more preferably less than 1% of the signal value. 
     The layer may be made substantially opaque through coloring. One such color would be a gray created by suspension of carbon black particles in the base material of the layer. This would be substantially opaque to both red and infrared. 
       FIG. 6  shows another embodiment of the invention in which a layer  60  over an emitter  62  and detector  64  has a series of perforations  66 . These perforations block the light path and scatter the light attempting to shunt between the emitter  62  and detector  64  through layer  60 . Although light tends to jump air gaps, by providing multiple air gaps in different orientations, the light can be somewhat effectively scattered. Alternately, the perforations could be filled with a colored filling material or putty to block the light that might otherwise jump the air gaps, or could have the inside walls of the perforations colored. Alternately, embossing (or other variations in thickness) could be used rather than perforations. 
       FIG. 7  illustrates a layer  70  having an emitter  72  and detector  74 , covered by another layer  76 . Layer  76  may be partially transparent for light to exit from emitter  72  and re-enter to detector  74 . Layer  76  has a thinned portion  78 , and layer  70  has a corresponding thinned portion  79 . These portions make the layers thin in that area, thus limiting the amount of light that may be shunted. The layer could be made thin by a number of techniques, such as embossing, welding or heat sealing. The width of the thinned area could be varied, and the shape could be varied as desired. For instance, the thinned area could extend around the sides of the emitter and detector, to prevent shunting of light from the edges of the layers when they are wrapped around a finger. 
     The thinness of the layer contributes to absorption of the light because light which is traveling in a thin layer will more often bounce off the layer boundaries than it would in a thick layer. This provides more chances to escape the layer and be lost or absorbed in an adjoining layer with absorption characteristics. 
     The thickness is preferably less than 0.25 mm and more preferably no more than 0.025 mm. The length of the thin section is preferably greater than 1 mm and more preferably greater than 3 mm. 
     The thin layer approach could be applied to a re-manufacture or other modification of a sensor which involves adding a layer over the emitter and detector. The entire layer could be made thin, preferably less than 0.25 mm, more preferably no more than 0.025 mm, in order to limit its shunting effect. 
       FIG. 8  shows a sensor having a layer  80  for an emitter  81  and a detector  82 , having transparent windows  83  and  84 , respectively. A substrate layer  85  supports the emitter and detector, with light being transmitted through transparent window  83  and received through window  84 . In one embodiment, the entire layer  80  is opaque, leaving transparent portions  83  and  84 . Alternately, the entire layer  80  may be transparent, or of one color with the windows of another or transparent. In addition, a portion  86  of layer  80  between the emitter and detector may be colored a substantially opaque color to prevent the shunting of light of the wavelengths of interest. In alternate embodiments, portion  86  may be of different shapes, and may partially or totally enclose the windows for the emitter and detector. 
       FIG. 9  shows another embodiment of a sensor according to the present invention mounted on a finger  90 . Two portions of a first layer,  91 ,  91 ′ have the emitter  92  and detector  93 , respectively, attached to them. A break between layers  91  and  91 ′ is provided in between the emitter and detector, which will be at the tip of finger  90 . Normally, this gap would provide an air gap through which light can be shunted between the emitter and detector across the top of the finger. However, by using a backing layer  94 , with an adhesive in the portion between layers  91  and  91 ′, this layer can stick to the tip of finger  90 , removing the air gap and thus substantially preventing shunting between the layers. 
     An alternate embodiment is shown in  FIG. 10 , with the finger  100  having a sensor with layers  91  and  91 ′ and emitter  92  and detector  93  as in  FIG. 9 . Here, however, a separate layer  94  is provided with a foam or other resilient or compressible pad  96  mounted on layer  94  between layers  91  and  91 ′. This material will compress against the tip of the finger, thus also blocking the air gap and preventing the shunting of light if the material is made of a substantially opaque material, such as a color that is substantially opaque to the wavelengths of interest (e.g., red and infrared), or is made of woven material or other material opaque to the light. 
       FIG. 11  is another embodiment of the present invention showing a layer  110  having an emitter  112  and a detector  114  mounted thereon. A covering, transparent layer  116  provides a covering and a window for the transmission and detection of light. Shunting of light is prevented by crimping the layers with a metal or other crimp  118 ,  120 . The metal or other material is substantially opaque to the shunted light of the wavelengths of interest, and completely penetrates the layer, or substantially penetrates the layer. 
       FIG. 12  shows an alternate embodiment in which a layer  121  has an emitter  122  and a detector  124  (both shown in phantom) mounted thereon. Over the emitter area is a first transparent layer  126 , with a second transparent layer  128  over the detector  124 . As can be seen, the two layers are overlapping, with the end  129  of layer  128  being on top of layer  126 . Thus, instead of an air gap, any shunted light from layer  128  is deflected to be above layer  126 , and vice versa. Alternately, since the light will originate from the emitter, it may be more preferable to have the layer overlaying the emitter be on top of the layer overlaying the detector. In the overlapping portion, a radiation blocking layer may be included, such as a colored adhesive. 
       FIG. 13  shows an alternate embodiment of the present invention in which a flexible circuit is printed onto a layer  130 . As shown, emitter  132  and detector  134  are mounted on the flexible layer  130 . A covering layer  133  is provided. Layers  130  and  133  may be partially or substantially opaque to prevent the shunting of light. In between the layers, metal traces  136  and  138  can be used to block the shunting of light. Instead of making these traces run lengthwise, leaving a clear path between the emitter and detector, they instead follow a tortuous path. This tortuous path not only goes lengthwise, but also goes across the width of the layer  130 , thus providing a barrier to block shunting the light between the emitter and detector. 
       FIG. 14  shows another embodiment of the present invention for modifying a sheath such as sheath  32  of  FIG. 2 .  FIG. 14  shows a sheath  140  having a first, adhesive layer  142 , and a second layer  144  being transparent and forming a pocket for the insertion of a sensor. Layer  144  has opaque colored rings  146  and  148  surrounding windows  147  and  149 , respectively. These windows allow the transmission of light to and from the emitter and detector, while the opaque rings prevent the shunting of light through transparent layer  144 . Alternately, more or less of the transparent layer  144  could be colored with an opaque color to prevent the shunting of light. 
     Alternately, in the embodiment of  FIG. 14 , windows  147  and  149  could be one color, while areas  146  and  148 , which may extend over the rest of the layer  144 , could be of a second color. The second color would be chosen to prevent shunting, while the first color would be chosen to allow the transmission of light while also being of a color which is compatible with the calibration data for an oximeter sensor. If the color over the emitter and detector is not chosen properly, it may interfere with the choice of a proper calibration curve in the oximeter sensor for the particular wavelength of the emitter being used. Typically, LEDs of slightly varying wavelengths are used, with a coding resistor indicating the exact wavelength. The coding resistor is used to choose a particular calibration curve of coefficients in the oximeter sensor. Thus, by using a differentially-colored sheath or reinforcing laminate or other layer, with the layer near the emitter and detector chosen to be white, clear or other color which does not interfere with the calibration, shunting can be prevented while allowing the sensor to be used without affecting its standard calibration. Preferably, the regions over the emitter and detector have a radius extending at least 2 mm. beyond the borders of the emitter and detector, and preferably at least 5 mm beyond the borders of the emitter and detector. 
     Any of the shunt barriers described above could be incorporated into layer  144  of sheath  140  of  FIG. 14 . Alternately, or in addition, the shunt barriers could be incorporated into a lamination or other layer placed over a sensor in a modifying process. Such a modifying process may, for instance, place a non-adhesive layer over an adhesive layer to convert a disposable sensor into a reusable sensor. The shunt barriers described above may also be in an original layer in a sensor, or in a replacement layer added in a remanufacturing process for recycling disposable sensors. 
     As will be understood by those of skill in the art, the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Accordingly, the foregoing description is intended to be illustrative, but not limiting, of the scope of the invention which is set forth in the following claims.

Technology Category: 1