Patent Application
20120071742
The present disclosure relates generally to remanufacturing disposable medical sensors and, more particularly, to remanufacturing, i.e., reconstructing, used stacked adhesive medical sensors.
This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.
A wide variety of devices have been developed for non-invasively monitoring physiological characteristics of patients. For example, a pulse oximetry sensor system may non-invasively detect various patient blood fluid characteristics, such as the blood-oxygen saturation of hemoglobin in arterial blood, the volume of individual blood pulsations supply the tissue, and/or the rate of blood pulsations corresponding to each heart beat of a patient. To determine these physiological characteristics, light may be emitted into patient tissue, where the light may be scattered and/or absorbed in a manner dependent on such physiological characteristics.
Many pulse oximeter medical sensors may be disposable and originally intended for use on a single patient. One such disposable medical sensor may be a stacked adhesive medical sensor such as the Max-Fast sensor by Nellcor, which may include multiple stacked adhesive layers for multiple reapplications onto patient tissue. In particular, a medical practitioner may first attach a stacked adhesive medical sensor to a patient tissue site via an outermost of the stacked adhesive layers. When the medical practitioner checks the sensor site at a later time, causing the medical sensor to lift away from the patient tissue, the outermost adhesive layer may be removed to expose a new, fresh adhesive layer underneath. The stacked adhesive medical sensor may be reattached to the tissue site using the newly exposed adhesive layer. When all of the adhesive layers have been removed or when the patient no longer needs monitoring, the stacked adhesive medical sensor is discarded.
A summary of certain embodiments disclosed herein is set forth below. It should be understood that these aspects are presented merely to provide the reader with a brief summary of these certain embodiments and that these aspects are not intended to limit the scope of this disclosure. Indeed, this disclosure may encompass a variety of aspects that may not be set forth below.
Embodiments of the present disclosure relate to remanufactured medical sensors and methods for remanufacturing used stacked adhesive medical sensors. Such a remanufactured sensor may include certain components from a used stacked adhesive medical sensor and certain new components. For example, a remanufactured medical sensor may include an exterior foam layer, a mask layer, an emitter and a detector, a semi-rigid optical mount to hold the emitter and the detector in place, optical windows, and an interior foam layer. At least the emitter and the detector may derive from the used stacked adhesive medical sensor, while at least one of the exterior foam layer, the mask layer, the semi-rigid optical mount, the optical windows, or the interior foam layer may be new.
Various refinements of the features noted above may exist in relation to various aspects of the present disclosure. Further features may also be incorporated in these various aspects as well. These refinements and additional features may exist individually or in any combination. For instance, various features discussed below in relation to one or more of the illustrated embodiments may be incorporated into any of the above-described aspects of the present disclosure alone or in any combination. Again, the brief summary presented above is intended only to familiarize the reader with certain aspects and contexts of embodiments of the present disclosure without limitation to the claimed subject matter.
Various aspects of this disclosure may be better understood upon reading the following detailed description and upon reference to the drawings in which:
One or more specific embodiments will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
When introducing elements of various embodiments of the present disclosure, the articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Also, as used herein, the term “over” or “above” refers to a component location on a medical sensor that is closer to patient tissue when the medical sensor is applied to the patient. For example, a stacked adhesive layer of a stacked adhesive medical sensor may be understood to be “over” or “above” the emitter or detector, as will be described below.
Present embodiments relate to remanufacturing used stacked adhesive medical sensors. As discussed above, a stacked adhesive medical sensor, when new, may include several stacked layers of adhesive that may be individually removed to extend the life of the medical sensor. By way of example, the Max-Fast pulse oximeter sensor by Nellcor represents such a stacked adhesive medical sensor. These medical sensors are generally known to be one-time-use medical sensors that may be disposed after use by one patient or after all of the stacked adhesive layers have been used. Though disposable, some components of used stacked adhesive medical sensors may be employed in the reconstruction of stacked adhesive medical sensors. As discussed in greater detail below, such components may include, for example, a cable, memory, an emitter and detector, components that hold the emitter and detector in place, and various layers that surround the emitter and detector. Reusing such components to reconstruct a stacked adhesive medical sensor may reduce waste, consequently reducing an impact on the environment, while accordingly reducing costs.
Thus, embodiments of the present disclosure involve remanufacturing used stacked adhesive medical sensors that may have various reusable components. For example, in some embodiments, foam layers encapsulating an emitter and detector may be reused while new stacked adhesive layers are replaced, with or without a new non-patient-contacting-side covering layer. In other embodiments, no stacked adhesive layers may be added, but other adhesives, such as gels, bandages, and/or adhesive dots may be applied to the covering of patient-contacting-side covering layer or headband-adhering-material may be attached to the exterior of a used stacked adhesive sensor. In certain embodiments, the electronic components and a non-patient-contacting side foam layer may be reused from a used stacked adhesive medical sensor and a patient-contacting-side foam layer and the stacked adhesive layers may be replaced. In still other embodiments, only certain electronic components such an emitter and a detector and/or accompanying components may be reused and all other layers may be replaced. The embodiments discussed above also may reuse certain electrical components, such as a cable, connector, and memory, which may be used to join the emitter and the detector to a patient monitor.
With the foregoing in mind,
The stacked adhesive medical sensor 14 may attach to pulsatile patient tissue (e.g., a patient's forehead). An emitter 20 and a detector 22 may operate to generate non-invasive pulse oximetry data for use by the patient monitor 12. In particular, the emitter 20 may transmit light at certain wavelengths into the tissue and the detector 22 may receive the light after it has passed through or is reflected by the tissue. The amount of light and/or certain characteristics of light waves passing through or reflected by the tissue may vary in accordance with changing amounts of blood contingents in the tissue, as well as related light absorption and/or scattering.
The emitter 20 may emit light from two or more light emitting diodes (LEDs) or other suitable light sources into the pulsatile tissue. The light that is reflected or transmitted through the tissue may be detected using the detector 22, which may be a photodetector (e.g., a photodiode), once the light has passed through or has been reflected by the pulsatile tissue. When the detector 22 detects this light, the detector 22 may generate a photocurrent proportional to the amount of detected light, which may be transmitted through the cable 16 to the patient monitor 12. The patient monitor 12 may convert the photocurrent from the detector 22 into a voltage signal that may be analyzed to determine certain physiological characteristics of the patient.
The remanufactured stacked adhesive medical sensor 14 may include certain new components and certain existing components from a used stacked adhesive medical sensor. Turning to
Additionally or alternatively, other recycle indicators may be present on the remanufactured stacked adhesive medical sensor 14. For example, embossing 28 may represent one recycle indicator, here indicating three remanufacturing times. Ink marks 30 on the cable 16, on the layers 24, or any other location may provide a similar indication, as may a cord tag 32. A cord clip 34 may be new or used and may attach to patient clothing or bedding during operation to secure this remanufactured stacked adhesive medical sensor 14 to the patient. In some embodiments, the clip 34 and/or an outermost non-patient-contacting-side layer 24 may indicate how many times the remanufactured stacked adhesive medical sensor 14 has been remanufactured (e.g., via ink marks or a specific coloring).
In certain embodiments, the remanufactured stacked adhesive medical sensor 14 may be held in place on a patient tissue site by an elastic headband 36, as shown in
As mentioned above, the remanufactured stacked adhesive medical sensor 14 may reuse certain existing components from a stacked adhesive medical sensor that has been used and/or discarded. Indeed, all of the embodiments of the remanufactured stacked adhesive medical sensor 14 may reuse the communication cable 16, the associated connector 26, and memory 27. In particular, the embodiments represented in
As shown in
Both the emitter 20 and the detector 22 may be attached to the mask layer 42. A Faraday shield 44 may be present around the detector 22 to reduce the effect of electrical fields on resulting photodetector signals. A semi-rigid optical mount 46 also may be present on the mask layer 42, surrounding and holding the emitter 20 and the detector 22 in a fixed manner while allowing a certain minimal amount of flexing and twisting to occur. This semi-rigid optical mount 46 also may be referred to as a “kayak” because of the way it holds the emitter 20 and the detector 22 in place. It should be noted that the semi-rigid optical mount 46 may prevent torque from causing orientation changes between the emitter 20 and the detector 22, which might interfere with the accuracy of measurements obtained by the detector 22 due to motion-induced artifacts and changes in calibration. Moreover, the optical mount 46 may serve as a shunt barrier between the emitter 20 and detector 22, and may be made of a black polypropylene material. Transparent windows 48 may couple to the semi-rigid optical mount 46 over the emitter 20 and detector 22.
A patient-contacting-side interior foam layer 50 may attach to the exterior foam layer 40 such that cutouts 52 fit around the optical windows 48 over the emitter 20 and detector 22. Like the exterior foam layer 40, the interior foam layer 50 may be formed from PVC foam or a urethane foam such as the as the PORON™ family of urethane foams. The interior foam layer 50 may attach to the exterior foam layer 40 using a pressure-sensitive adhesive or any other suitable adhesive. A number of stacked adhesive layers 54A-C may attach to the interior foam layer 50. The lowermost stacked adhesive layer 54A may attach to the interior foam layer 50 through an acrylic transfer adhesive or another suitable form of adhesive. Although only three stacked adhesive layers 54A-C are shown, it should be appreciated that any suitable number of stacked adhesive layers 54 may be present on the stacked adhesive medical sensor 14.
As shown in
As noted above, the remanufactured stacked adhesive medical sensor 14 of
Similarly,
As will be discussed below, to obtain the remanufactured stacked adhesive medical sensors 14 shown in
In another embodiment, represented by
The examples of stacked adhesive medical sensors 14 described above with reference to
The remanufactured stacked adhesive medical sensors 14 described above with reference to
The used stacked adhesive medical sensor next may be inspected preliminarily for apparent deficiencies that would make the sensor unsatisfactory for remanufacturing (block 74). If the used stacked adhesive medical sensor appears unsatisfactory (decision block 76), the sensor may be simply discarded (block 78). Otherwise, if the used stacked adhesive medical sensor does not preliminarily appear unsatisfactory (decision block 76), the number of times the used stacked adhesive medical sensor has been recycled may be determined (block 80).
The number of sensor recycle times may be determined in block 80 visually or by examining certain data stored in memory 27 in the connector 26 of the used stacked adhesive medical sensor. For example, in carrying out block 80, certain visual recycle indicators may be examined to ascertain a total recycle count for the used stacked adhesive medical sensor. For such embodiments, the number of times that the used stacked adhesive medical sensor has been used may appear in embossing 28, an ink indicator 30, on a cord tag 32, and/or as an exterior cover layer 64, and so forth. Additionally or alternatively, a recycle counter stored in the memory 27 of the connector 26 of the used stacked adhesive medical sensor may indicate the number of times the used stacked adhesive medical sensor has previously been recycled. If the used stacked adhesive medical sensor has already been recycled too many times (decision block 82), the used stacked adhesive medical sensor may be discarded (block 84). Otherwise, if the number of times the used stacked adhesive medical sensor has been recycled falls beneath a threshold (e.g., five times), the remanufacturing process of flowchart 70 may continue.
That is, in some embodiments, unused stacked adhesive layers 54A-C remaining on the used stacked adhesive medical sensor may be removed (block 86). Specifically, block 86 may take place to generate the remanufactured stacked adhesive medical sensors 14 illustrated in
In some embodiments, the obtained used stacked adhesive medical sensor may store certain patient trend data in memory 27 located on the connector 26. If this trend data were to remain, the remanufactured stacked adhesive sensor 14 could wrongly indicate the subsequent patients' history. Accordingly, the trend data stored in the memory 27 on the connector 26 may be clear or overwritten and/or the trend feature may be disabled, for example, by setting a flag bit in a register of the memory 27 of the connector 26 (block 90).
In some embodiments, such as the embodiment discussed above with reference to
Having attached the new components 60 to the existing components 58 of the used stacked adhesive medical sensor, a series of sensor diagnostic tests may be performed (block 96). Such tests may include, for example, electrical tests (e.g., open-short, connectors, solder joint integrity, and so forth), detector 22 integrity tests, and/or tests on the wavelength of the emitter 20. A test for detector noise may indicate whether the Faraday shield 44 remains intact and at the proper placement. Additionally, in some embodiments, the emitter 20 wavelength may be tested to ensure that the wavelength of light emitted by the emitter 20 has not shifted beyond a point permitted by a calibration coefficient, which may be stored on the memory 27 of the connector 26. Although the used stacked adhesive medical sensor may not include a resistor indicating a bin to which the emitter 20 wavelength is assigned, data stored on the memory 27 of the connector 26 may be detected and, based on such data, the wavelength of the emitter 20 may be determined. From this determined wavelength, it may become apparent whether the wavelength of light currently being emitted by the emitter 20 has shifted beyond a point permitted by the calibration coefficient.
If any of the diagnostic tests of block 96 result in failure (decision block 98), the used stacked adhesive medical sensor may be sent to a further inspection procedure 100, such as described in greater detail below (block 100). Otherwise, if the used stacked adhesive medical sensor as past the sensor diagnostic tests of block 96 (decision block 98), the remanufacturing process may be completed and the remanufactured stacked adhesive medical sensor 14 may be prepared for use by a medical facility. Specifically, a recycle counter indicator of the remanufactured stacked adhesive medical sensor 14, such as the embossing 28, an ink indicator 30, a cord tag 32, and/or an exterior cover layer 64 may be incremented or memory 27 stored on the connector 26 may be incremented (block 102). Thereafter, the cord 16 may be wrapped, the remanufactured stacked adhesive medical sensor 14 may be placed into a package, and the package may be sterilized, pasteurized, or otherwise cleaned in any suitable manner (block 104). The remanufactured stacked adhesive medical sensor 14 then may be sent to a medical facility.
In some embodiments, the remanufactured stacked adhesive medical sensor 14 may not include any additional stacked adhesive layers 54A-C. Rather, as shown by
As shown in
Remanufacturing a used stacked adhesive medical sensor to produce the remanufactured stacked adhesive medical sensors 14 shown in by
Blocks 146-152 also may be performed in substantially the same manner as blocks 96-102 of
In some embodiments, the remanufactured stacked adhesive medical sensor 14 may reuse existing components 58 between and including the exterior foam layer 40 through the windows 48, but not the interior foam layer 50. That is, the new components 60 of the remanufactured stacked adhesive medical sensor 14 of
Because the interior foam layer 50 may be replaced in the remanufactured stacked adhesive medical sensor 14 shown in
Thereafter, the windows 48, semi-rigid optical mount 46, and mask layer 42 may be exposed. In this configuration, the windows 48 and/or the semi-rigid optical mount 46 may be inspected for damage or debris (block 180). If any damage or debris is detected (decision block 182), the used stacked adhesive medical sensor may be sent away for further inspection (block 184).
If no problems with the windows 48 or the semi-rigid optical mount 46 are detected (decision block 182), a new interior foam layer 50 may be attached to the exterior foam layer 40 over the emitter 20 and detector 22, such that the cutouts 52 surround the respective windows 48 (block 186). New stacked adhesive layers 54A-C in a release liner next may be attached to the new interior foam layer 50 (block 188). In some embodiments, in lieu of block 188, adhesive dots may be applied or other adhesives supplied in the package with the remanufactured stacked adhesive medical sensor 14. Blocks 190-196 may be performed in substantially the same manner as blocks 96-102 of
Another embodiment of the remanufactured stacked adhesive medical sensor 14 is represented by
Such a remanufacturing process is described by a flowchart 210 of
The exposed components (the emitter 20, the detector 22, the Faraday shield 44, the semi-rigid optical mounts 46, and the windows 48) next may be carefully separated from the mask layer 42 and the exterior foam layer 40 (block 232). With all of the electrical components visible, the solder joints next may be inspected (block 234). If a problem is apparent (decision block 236), the solder joints may be repaired (block 238). Additionally, the windows 48 may be inspected for signs of damage or debris and, if such damage or debris is found, the used stacked adhesive medical sensor may be sent away for additional inspection (block 240).
The Faraday shield 44 over the detector 22 next may be visually inspected through a window 48 over the detector 22 (block 242). If the Faraday shield appears damaged (decision block 244), the used stacked adhesive medical sensor may be discarded or may be sent away for further inspection (block 246) (e.g., for remanufacturing according to the method of
Finally, in some embodiments, substantially only the emitter 20 and detector 22 (as well as the cord 16 and connector 26) may be existing components 58 from a used stacked adhesive medical sensor that are reused in a remanufactured stacked adhesive medical sensor 14, as shown in
A flowchart 260 of
The number of times the used stacked adhesive medical sensor has been recycled next may be determined (block 270) in substantially the same manner as block 80 of
Next, any unused stacked adhesive layers 54A-C remaining on the used stacked adhesive medical sensor, the exterior foam layer 40, the interior foam layer 50, and any remaining mask layer 42 material around the electronic components may be removed (block 278). With the electronic components of the used stacked adhesive medical sensor exposed, the windows 48 may be removed (block 280) before the emitter 20 and detector 22 are removed from the semi-rigid optical mount 46 (the “kayak”) (block 282). At this point or another point, these remaining components may be cleaned by, for example, wiping the sensor with 70 percent isopropyl alcohol or any other suitable cleaning solution, or by other means such as pasteurization or application of ethylene oxide (EtO).
With the emitter 20 and detector 22 exposed, the solder joints and/or the Faraday shield 44 next may be inspected (block 284). If a problem is apparent (decision block 286), the solder joints may be repaired and/or the Faraday shield 44 replaced (block 288). The emitter 20 and the detector 22 may be replaced into a new semi-rigid optical mount 46 (a new “kayak”) (block 290) and new windows 48 placed over the emitter 20 and detector 22 (block 292). Thereafter, the used stacked adhesive medical sensor may be cleaned according to any suitable technique, such as those mentioned above. These inspected existing components 58 of the used stacked adhesive medical sensor may now form a basis around which the remanufactured stacked adhesive medical sensor 14 may be completed. In particular, the remanufactured stacked adhesive medical sensor 14 may be completed using any suitable manufacturing protocol (block 294), which may include the same standard manufacturing techniques used to manufacture an original stacked adhesive medical sensor, except that recycle indicators may be updated and/or trend data may be cleared or disabled. In some embodiments, block 294 of
The specific embodiments described above have been shown by way of example, and it should be understood that these embodiments may be susceptible to various modifications and alternative forms. It should be further understood that the claims are not intended to be limited to the particular forms disclosed, but rather to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure.
