ASSEMBLY OF DISPOSABLE PULSE OXY ETRO AND PROTECTIVE COVER FOR THE SAMEFIELD OF THE INVENTION The invention focuses on a method and device for measuring the oxygenation of blood in areas where body fluids can compromise the electrical components. More particularly, the invention relates to a disposable pulse oximeter assembly that includes a protective cover and a disposable pulse oximeter.
BACKGROUND OF THE INVENTIONWith a few exceptions, tradition and technology have favored pulse oximetry by transillumination, in the area of operations. The operating principle of the pulse oximeter is quite simple but arguably is the most important development in themonitoring of anesthesia in the twentieth century. two wavelengths of light (usually 660 nm and 940 nm) are used to determine spectrophotometrically noninvasively, the proportion of oxidized hemoglobin respect to reduced hemoglobin and to determineplethysmographically the pulsation capacity of the blood. Currently the most common application of this, in the area of'& ^ £ 1? * & , Z ~, ..._, AfeüaaBfcAM; ... - ...... i ,. -, - r | ^ tjj¡ ^ jt | ^ jj ^ ___ I__ _ t ^ operations, is through the transillumination through the capillary bed of a peripheral digit. However, it is not usual for patients with multiple trauma and thermal injury, who have either severe peripheral vasoconstriction or have peripheral vascular beds severely damaged (or missing due to amputation). Reflectance oximetry, instead of transillumination oximetry, was the first form of investigation of the technique. Pulse oximetry by transillumination, is undoubtedly the most effective way when oximetry is obtained through the skin. However, when the skin is not interposed as a barrier for access to the capillary bed, pulse oximetry by reflectance can be easily achieved, with very accurate results. The effect is achieved by backscattering incoming bispectral light that passes through and, with reflection from non-absorbing collagenous tissues, re-traverses the elements formed in the blood to return to the oximetric detector. Rather than impersonating pulse oximetry by transillumination, this technique broadens the scope of potential monitoring sites, adding to the armamentarium of physicians. Conventional pulse oximetry in patients with severe burns can be a significant challenge, but these data are vital in the operating room and intensive care facilities. Most of the- '•••• "^ ----» • U --- n ^^ ^^^ g & I Common oximetry approaches depend on peripheral sites available that allow transillumination oximetry and indeed this method is sufficient to most conditions and surgical procedures. Unfortunately 5 patients with severe burns often have few sites for the effective placement of the sensor of the pulse oximeter transillumination. Moreover, these patients often have a severe circulatory compromise that causes the oximeter Peripheral pulse measurement is less efficient A variety of studies have shown that pulse oximeter sensors are sensitive more quickly and reliably than peripheral pulse oximeter sensors, but many of these studies use oximetry. pulse by transillumination, oral, staying in place 15 through complex devices or improvised malleable metal parts. Oral secretions, breakdowns in the equipment, and the difficulty of placement often make these techniques ineffective. Reflectance oximetry can be a useful tool where a capillary bed can be easily accessed. In fact, it is used in a common and effective way in intrapartum and neonatal patients, whose capillary beds can be easily accessed through their skin. The technique has also been applied to adult patients 25 and pediatric patients, with burns, by placing the^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^ - ^ # ^ ** ^ reflectance sensor in wounds or on hyperemic sites such as healed scars with partial thickness. A variety of other useful capillary beds will exist that will provide better and more accurate data and that can not be easily obtained with common disposable pulse oximeter sensors. The body fluids that contact sensors pulse oximeters, disposable, standard manufacturing insertion in an open wound or body cavity, adversely affect the operation of sensors pulse oximeters. Disposable pulse oximeter sensors, such as the NellcorMR OxisensorMR II D-25, will start to malfunction electrically over time, because fluid from the body cavity or wound will start to break the protective material that It is located around the electrical components and will then leak into the area around the electrical components and short-circuit the disposable pulse oximeter sensor, causing the sensor to malfunction. It is difficult to predict when a disposable pulse oximeter sensor will malfunction due to the exposure of its electrical components. Accordingly, there is a need to protect disposable, standardized pulse oximeter sensors with a disposable protective cover for use in fluid areas.
DESCRIPTION OF THE INVENTIONThis invention solves the current problems of using pulse oximeter sensors, disposable, of normalized manufacture, in cavities filled with liquids and / or wounds, either in humans or animals. The invention, while addressing the problems of the prior art, obtains advantages that could not be achieved with the devices of the prior art. The invention encompasses a protective cover for protecting a pulse oximeter sensor, of standard manufacture, disposable. An object of the invention is to obtain oximetric measurements from more areas in addition to the internal sites, either with a complex or multi-purpose apparatus, or at external sites. Another object of the invention is to allow lingual placement of a disposable pulse oximeter sensor for reflectance readings and to provide pulse oximetry measurements that are efficient and clinically accurate. Another object of the invention is to allow the, & , ^, ^ J £ s? ..- > . ^^ í .. ^. ^. " -, ^^^ - ", _. ^," .. ^ .. ^ ^ ,. .?. £. ^. ^ Oral placement of a disposable sensor pulse oximeter, for reflectance readings and provide measurements of pulse oximetry, efficient and clinically accurate. An advantage of the invention is an improvement in the quality of care, resulting from the elimination of the need to have and assemble complex apparatus for taking measurements and internal oximetry readings. Another advantage of the invention is improved pulse oximetry readings for pulse oximeter sensors, disposable, because the pulse oximeter sensors will be protected from body fluids, while maintaining the flexibility of the sensors of the pulse oximeters. pulse oximeters. Another advantage of the invention is readings pulse oximeters, improved, for sensors pulse oximeters, disposable, because when the invention is internally used within an individual or animal, the skin protect the sensor pulse oximeter , at least of certain lighting coming from the surrounding environment. Another advantage of the invention is that a specialized probe and / or equipment is not required to take internal oximetry readings. Another advantage of the invention is that pulse oximetry by reflectance, which uses the lingual surfaceSuperior and a sensor. "Pulse oximetry, disposable, standard, is a viable way, efficient and effective, from the point of view of cost, to monitor patients difficult to monitor during surgery. Another advantage of the invention is that pulse oximetry by reflectance, which uses the buccal surface and a disposable, standard pulse oximetry sensor, is a viable, efficient, and cost-effective way of monitor difficult-to-monitor patients, 10 during surgery. The invention achieves the above objects and achieves the advantages. The invention easily adapts to a wide variety of situations. Given the following description of the drawings, the apparatus will be apparent to a person of ordinary skill in the art.
BRIEF DESCRIPTION OF THE DRAWINGSFigure 1 illustrates a plan view of a preferred embodiment. Figure 2 illustrates a side view of the embodiment shown in Figure 1. Figures 3a and 3b represent alternate embodiments of the protective cover in accordance withinvention. Figure 4 illustrates a plan view of the embodiment shown in Figure 1, covering a disposable pulse oximeter sensor. Figure 5 illustrates a side view of the embodiment shown in Figure 1, covering a disposable pulse oximeter sensor. Figure 6 illustrates an end view of the embodiment shown in Figure 1, covering a disposable, 0 pulse oximeter sensor.
THE BEST WAYS TO CARRY OUT THE MODALITIESDESCRITESIn accordance with the present invention, a combination pulse oximeter sensor assembly is provided, which includes a pulse oximeter sensor and a protective cover. Figures 1 and 2 illustrate a preferred embodiment of the protective cover. Figures 5 and 6 represent the preferred embodiment of the pulse, disposable, combination pulse oximeter sensor assembly. The same reference numbers in the figures represent and refer to the same element. With reference to figures 1 and 4, the protective cover 10 may include a condom, a shell or^^^^^^^^^^^ j ^^ r ^ r ^^^ - ^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^ translucent rubber, or a material ^ Similar. Preferably the protective cover 10 includes a substantially transparent section to be placed adjacent to the light source and - *a light detector of a pulse oximeter sensor 20, to facilitate the transmission of light to and from the pulse oximeter sensor 20. The protective cover 10 preferably includes a top surface 11 and a bottom surface 12. The protective cover 10 further includes aproximal end 14 and a distal end 13 having a pocket formed therebetween. The distal end 13 is preferably sealed while the proximal end 14 includes an opening to allow insertion of the pulse oximeter sensor 20. The pulse oximeter sensor 20 includes a light source, a light detector, wiring, probe fixing tape and / or covers 22 of plastic tape, and a connector cable 24. The light source may consist of one or more light emitters such as electroluminescent diodes(LED), a bispectral emitter, a dual spectral emitter, a light emitter, or a semiconductor die. The light detector may be one of the following: a photoelectric receiver, a photodetector, or a semiconductor die. The wiring includes conductive lines and contact electrodes. In accordance with the invention, the sensor 20 of thej-ana ? M ».. *! & **«. - ~ «. H.H! S2 £ & t & . * *. *. ....pulse oximeter may be placed inside the protective cover 10. To facilitate insertion, removal and storage of the pulse oximeter sensor 20 in the protective cover 10, the proximal end 14 of the cover"Protector 5" is preferably wider than distal end 13. In a preferred embodiment the width of the pocket formed between the distal and proximal ends 13 and 14 increases along the length of the protective cover 10. In accordance with a featureParticularly preferred of the invention, the change in the width of the opening, along the length of the protective cover 10, is about half a centimeter. How a person of experience will understandIn the art, the protective cover 10 can be implemented in a variety of geometries. For example, according to one aspect of the invention, the protective cover 10 may include first and second edges 15 and 17. In one embodiment, as shown in FIG. 1, theThe first edge 15 may be angularly offset relative to the axis of the protective cover 10. In another embodiment, each of the first and second edges 15 and 17 may be angularly offset from the axis of the protective cover, as shown in FIG. figure 3Still in another mode, as illustrated in the figureWhen the first edge 15 can include a first section that is angularly displaced from the axis of the protective cover 10 near the distal end 13 and a second section that is substantially parallel to the axis of the protective cover 10 near the proximal end 14. The second edge 17 can be an image in the mirror of the first edge 15 or the second edge can be parallel to the axis of the protective cover 10 along the entire length of the protective cover 10 (not shown). A person of ordinary skill in the art will appreciate that the foregoing constitutes only a representative sample of suitable geometries for the protective cover. The angularly displaced edges increase the convenience of using pulse oximeter sensors, of standardized manufacture, because the adhesive portions 22 can be folded inward without mutilating the pulse oximeter sensor, by removing or cutting the adhesive portions. In addition, the protective cover 10 is preferably bilaminar in nature to contain a substantially rectangular pulse oximeter sensor 20, with probe fastening tape and / or plastic sheet covers 22 folded back. The proximal end 14 may include a flap that extends, either from the upper surface 11 or from the surface of the bottom 12 to fold backward and seal the protective cover 10 or certain type** .. *** ^. *. ~ ~ ^, .. ^ A ^ .. .... ... ... > A «^. > ..-.... ^. - > ^ - ^ ._ ^ .. ^^ A-aftfr-t- & _ ..of adhesive within the bag, near the jppb% imal end 14 to seal the protective cover 10. The protective cover 10 preferably covers and encloses the pulse oximeter sensor 20 and a portion of the connector wire 24 extending from the sensor 20 of the pulse oximeter. In commercial applications it is expected that the protective cover 10 is disposable. The protective cover 10 can serve as an envelope type structure for the pulse oximeter sensor 20 to be inserted in for use. In particular, the structure of the protective cover 10 can be a bilaminar, flat blind bag. As a result, the protective cover 10 isolates the sensor 20 from the pulse oximeter, from direct contact with body fluids or related to surgery, consequently protecting the electrical components of the pulse oximeter sensor 20 against the fluid. The protective cover 10 is easily manufactured. According to a preferred manufacturing method, the first step is to lay flat two polypropylene sheets, or a similar non-reactive material, on a substantially flat surface, such that the two sheets overlap in the area where they are placed. they will form the protective covers. Subsequently, using a sealer or thermal gun, the sheets can be subdivided into individual protective covers. The sealer or gunthermal will allow the manufacturer subdivided the surface area of the sheets, into individual protective covers that will have their sides formed by merging the two sheets together to form seams. A person of ordinary skill in the art will appreciate that the two polypropylene sheets can be replaced with a large polypropylene bag or similar material. A person of ordinary skill in the art will also appreciate that the two polypropylene sheets can be replaced with a sheet of polypropylene or similar material, folded in such a way that the fold line forms the side of the protective covers formed along the length of the sheet. the crease line The protective cover 10 will allow the sensors 20 of the pulse oximeter, disposable, of normalized manufacture, are used in a greater number of sites within patients or animals. In particular, oximetry will be able to be carried out in the oral cavity on the lingual or buccal mucosa, the palate or the posterior pharynx, as well as on the intravaginal or intrarectal capillary beds. However, it is not easy to take readings in the intra-rectal capillaries due to the presence of fecal waste and iron in the rectum. Also, pulse oximetry in any area where bodily or surgical fluids may otherwise cause contamination of the parts. x ~ ...,. - £ _Bé_-¿.r. «? ^ A ~ .. ,,. -, - - ^^ j ^ fcr -. ^^^ - ^^^^ afifa. ^ A, Dielectric of the sensor 20 of a pulse oximeter. The protective cover 10 will also increase the disposal possibilities of the sensors of the pulse oximeter of standard manufacture, in veterinary medicine. An example of a disposable pulse oximeter sensor 20, which will have an increased use, is the Nellcor ™ Oxisensor ™ II line of pulse oximeter probes and sensors (Nellcor Puritan Bennett *, Inc., Pleasanton, California). With regard to the lingual and buccal mucosae, pulse oximetry by reflectance will be carried out more easily without the use of complex and specialized probes. The insulation aspects of the protective cover 10 will allow the use of pulse oximeter sensors 20 to perform perioral, perilingual, sublingual, peripalatal, periphyreal, peri-vaginal, perirectal, and surgical site oximetry. To take readings of the oral surface, the jaw of the patient must be opened to allow access to the oral surface. The protective cover 10 with the pulse oximeter sensor 20, inserted, can be placed against the buccal surface. When the jaw is closed, the muscles will contract and close around the protective cover 10, thus holding the protective cover 10 and the sensor 20 of the pulse oximeter, against the buccal surface. It is possible to obtain a tighter adjustment, due to the flexible nature of the^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^ combination of the protective cover 10 and the sensor 20 of the pulse oximeter. This assembly is capable of performing lingual oximetry as described by the following'5 analysis. There is a capillary bed that is often not considered, which can be easily accessed in most adult patients with burns, which is so favorable to practice reflectance oximetry, asthe forehead of a premature infant. The tongue of a patient with burns is rarely compromised, no matter how severe the burns are, and the capillary bed is located near the surface of the tongue. Pulse oximetry by transillumination, of the tongue, hashas been documented as a viable monitoring method, but not everyone has the equipment available to place a pulse oximeter by transillumination, on the tongue. A reflectance pulse oximeter sensor has the light source and the light detector in a side-by-side configurationside, instead of one opposite the other. A disposable pulse oximeter probe, such as the Nellcor ™ Oxisensor ™ II D-25, can be easily placed in this manner. The device can be placed in a flat position on an appropriate capillary bed and in this way it becomes a sensor ofpulse oximeter by reflectance. In this way, a sensorThe pulse oximeter, disposable, standard, for finger, can simply be placed in a flat position on the tongue, without the need for fasteners or tapes, thus converting it into a reflectance device instead of a transillumination device."5 A method for taking readings of the pulse oximeter from the lingual and buccal surfaces within a patient has been subjected to the actual analysis in the population described below and in accordance with the following protocols: 10 Regarding the study of the readings of the pulse oximeter, of the lingual surface, data were reviewed for eight patients difficult to monitor, who had been monitored through pulse oximetry by reflectance, lingual, through 25 proceduresconsecutive surgeries, all consisting of removal of the burn and graft. The age of the patients varied from 26 to 57 years (Mean = 36.0, Standard Deviation (SD) = 10.3). The burn area of the patients varied from 20% to 92% of the total surface area of the body (% TBSA) (Mean = 66.75%, SD= 26.42). The number of operations per patient varied from one to five (Mean = 3.13, SD = 1.55). Six of these eight patients arrived at the tubed operating room for all operations in this study. Two patients were induced and intubated in a standard manner. 25 In each case, a NellcorMR OxisensorMR II D-25 willplaced centered in a flat position on the upper lingual surface, where the detector and the bispectral emitter were oriented towards the lingual surface. This orientation of the pulse oximeter was used for the duration of* 5 each case. When clinically indicated, a sample of arterial blood gas (ABG) was withdrawn and the Sp02 value (oxygen saturation in hemoglobin) was recorded for clinical monitoring and before transfusion in each case. All received multiple ABG extractions and allpatients were transfused. In each case the Sa02 (oxygen saturation of arterial blood) value of the ABG was noted. The descriptive statistics and a concordance ratio were calculated, as well as a t test for the correlated means, between the values Sp02 and Sa02.obtained simultaneously. The difference between the values Sp02 and Sa02 was insignificant by means of the test t for the correlated means (t = 1.25, df = 24, NS). By inspection, the stockings were very close and the standard deviations were very small, just likewere the SEM, suggesting all this very little difference or variability between these two measures of oxygen saturation. A concordance rate of 92% (+ 1.5%) was calculated, showing a high degree of relationship between lingual Sa02 and ABG. 25 These data suggest that oximetry byLingual reflectance is a simple and accurate means to monitor arterial oxygen saturation in the patient with severe burns, where oxymetric monitoring presents a challenge. In this study, a disposable, existing pulse oximeter 5 was used, saving the cost of specially designed equipment. Since it has been demonstrated that central oximetry is more quickly sensitive to the variability of oxygen saturation than peripheral oximetry, there are few disadvantages and a benefitconsiderable from this method. One disadvantage is that the technique is probably limited to tube patients, since awake and extubated patients may find the presence of a lingual pulse oximeter irritating. However, this limitation would be in accordance withthe pulse oximetry by lingual transillumination, as such. In addition to operating room considerations, ventilated patients in intensive care facilities may benefit from this technique, especially due to the faster response of an oximeterof pulse placed centrally, with respect to a peripheral one. In relation to the pulse oximeter readings, under study, of the oral surface, nine patients were monitored through pulse oximetry byreflectance, oral, through 20 proceduresconsecutive surgeries, procedures that consisted of removing the burns and grafting. The age of the patients varied from 23 to 56 years (Mean = 34.8, SD = 11.2) and the areas with burns ranged from 17% to 75% of TBSA 5 (Mean = 44.3%, SD = 28.9). Each patient received from one to eight operations (Mean = 4.01). Five of these nine patients arrived at the tubed operating room, for all operations in this study. Four patients were induced and intubated in a standard manner, toall surgical procedures. A Nellcor "11 Oxisensor ™ D-25 was inserted intraorally between the lower teeth and the left or right buccal surface of the cheek and lip, with the bispectral emitter and sensor, oriented towards the surfacebuccal This configuration of the pulse oximeter was used for the duration of each case. In addition, a similar disposable oximetric probe was placed over a peripheral digit in the commonly accepted transillumination configuration. The values for both oximetric probes were coded in theanesthesia record at five minute intervals throughout the case. The differences between peripheral and buccal SP02 values were insignificant through the t tests for the correlated means. For all thecases were calculated proportions of concordance aspercentage agreements. The average percentage agreement was 84%, varying from 25% to 100%. Three of the 20 samples had percentage agreements lower than 91%. In each of these cases, the peripheral pulse oximeter seems to have failed,'5 in two cases secondary to sepsis, and in another secondary to peripheral vasoconstriction despite an infusion of norepinephrine. Oral SpO2 readings, in all three cases, continued to be 97% or greater. These data suggest that the oximetry ofBuccal reflectance is a simple and accurate means to monitor arterial oxygen saturation in patients with severe burns, where oximetric monitoring presents a challenge. Since central oximetry has shown, in numerous studies, to be fastersensitive to the variability of oxygen saturation, than peripheral oximetry, as well as more directly reflecting the central oxygen saturation, there are few disadvantages and a considerable benefit of this method. Indeed, in the three examples in this study, where thepercentage agreements were low, peripheral oxymetric probes were providing apparently erratic and / or generally low values, while oximetric buccal readings remained at a value of 97% or higher. All three of these patients had a vascular compromisesecondary peripheral to sepsis and / or to an agentvasoconstrictor (infusion of norepinephrine). From the results of the study it might seem, at first glance, that a wide range of Sp02 values was not analyzed and that the continuously high Sp02 readings are false for the technique. On the contrary, in order to obtain an Sp02 value greater or less than 85%, a very specific set of relations must be present in relation to the bispectral emitter and the light-detecting oximetric elements. In this way, falsely high values, in particular, do not occur consistently. High values of Sp02 require the presence of saturated hemoglobin. Unlike lingual oximetry, this technique is not necessarily limited to tube patients, since a disposable, flat oxymetric probe could be placed between the cheeks and teeth of an awake patient. In addition to the considerations of the operating room, patients ventilated in intensive care facilities could benefit from this technique, especially given the faster response of a pulse oximeter placed centrally, in relation to a peripheral one.
INDUSTRIAL APPLICABILITYThe invention is particularly useful for. ^ ** ^ * ^ "*. . , ftf * éAA? (tn &. ...:... ^ ^ aad? mS? s8? 3 & amp; amp; l: monitor the oxygen content in the blood of a subject. be used by hospital staff, emergency medical groups, medical personnel at home, laboratory and veterinary personnel, and medical personnel in battlefields.It will be appreciated by those skilled in the art that various adaptations and modifications of the preferred embodiments described can be configured. previously, without departing from the scope and spirit of the invention.
Therefore, it should be understood that, within the scope of the appended claims, the invention may be practiced and constructed in a manner different from that specifically described herein.fifteentwenty