Tympanic thermometer probe cover with film support mechanism

ES 2 337 488 T3

DESCRIPTION

Probe cover for an eardrum thermometer with film support mechanism.

Invention field

The present description relates generally to the field of biomedical thermometers, and more particularly, to a probe cover for an eardrum thermometer.

Background of the invention

Medical thermometers are typically used to facilitate the prevention, diagnosis and treatment of diseases, bodily ailments, etc. of humans and other animals, as is known. Thermometers are used by physicians, nurses, parents, caregivers, etc. to measure the body temperature of a subject to detect fever, scan the subject's body temperature, etc. An accurate reading of a subject's body temperature is necessary for effective use and should be taken from within or from the inner core of a subject's body. Various devices are known for measuring the temperature of a subject, such as, for example, glass, electronic, ear (eardrum).

However, glass thermometers are very slow to take measurements as they take several minutes to determine body temperature. This can be uncomfortable for the subject, and it can be very painful to take the temperature of a small child or an invalid. Furthermore, glass thermometers are susceptible to errors and are usually only accurate within a range.

Electronic thermometers have shorter measurement times and higher accuracy than glass thermometers. However, electronic thermometers still take approximately thirty (30) seconds to get an accurate reading. This can be a cause of discomfort as the thermometer device must be inserted into the subject's mouth, rectum, or armpit.

Eardrum thermometers are generally regarded by the medical community as superior for taking a subject's temperature. Eardrum thermometers provide fast and accurate internal temperature readings, thereby overcoming the disadvantages associated with other types of thermometers. Eardrum thermometers measure temperature by detecting infrared emissions from the eardrum (ear membrane) in the outer ear canal.

The temperature of the eardrum accurately represents the internal temperature of the body. Furthermore, it only takes a few seconds to measure a subject's temperature in this way.

In operation, an eardrum thermometer is prepared for use and a probe cover is mounted over a detector probe extending from a distal portion of the thermometer. The probe cover provides a sanitary barrier between the subject and the thermometer. A professional or other caregiver inserts a portion of the probe that has the probe cover mounted on it into the subject's outer ear canal to detect infrared emissions from the eardrum. Infrared light emitted by the tympanic membrane passes through a window in the probe cover and is directed to the detection probe by a guide wave. The essential feature of the window is that it is substantially transparent to infrared radiation, which allows infrared radiation from the tympanic membrane to pass through the probe cover to the heat sensing probe of the thermometer. Although an open window would be suitable for taking a temperature measurement, a film (for example a plastic film) having a thickness on the order of the wavelength of radiation in the far infrared range normally covers the window to provide a sanitary barrier.

The professional presses a button or similar device to make the thermometer take a temperature measurement. Microelectronic devices process electrical signals from the thermal sensor to determine the temperature of the ear membrane and achieve a temperature measurement in a few seconds or less. The probe is removed from the ear canal and the probe cover is discarded. A new probe cover is used each time the thermometer is used with a new subject.

Known eardrum thermometers typically include a probe that contains a thermal sensor such as a thermopile, a pyroelectric thermal sensor, etc. See, for example, US Patents No.^you 6,179,785, 6,186,959 and 5,820,264. These types of thermal sensors are especially sensitive to radiant thermal energy from the ear membrane. The accuracy with which the detector probe detects infrared radiation emitted by the ear membrane directly corresponds to the overall accuracy, repeatability, and utility of the eardrum thermometer. The detector probe has to be sensitive to the low level of infrared energy emitted by an ear membrane while providing a high level of precision, repeatability and immunity to thermal noise.

A probe cover of an eardrum thermometer is described in WO 2004/063688.

Current eardrum thermometers employ probe covers that can adversely affect the accuracy of a temperature reading. The window of the probe cover normally makes contact with the probe. For the

Therefore, the distal end of the probe may be disadvantageously heated by conductive heat transfer from the window, which is heated by its proximity to the subject. This can cause the detector probe to detect radiation emitted from the probe's distal end or from other unwanted sources causing thermal noise to cause an unwanted temperature measurement. In addition, current probe cover designs suffer from other disadvantages, such as poor retention characteristics with the probe and discomfort to the subject when inserted into the ear canal. Furthermore, the window through which infrared radiation passes can be deformed during the measurement process. Such deformations can be caused by manufacturing inconsistencies and / or by deformation of the probe cover after insertion of the probe into the cover or by insertion of the probe into the ear canal.

Other examples of eardrum thermometer probe covers are described in US Patent No. 6,022,140 and WO 00/52434. US Patent No. 6,022,140 discloses various structures that either insulate a window of a cover film from externally applied forces or develop counter forces to prevent the film from stretching, as well as the transmission of other deformation effects. In WO 00/52434 a sleeve is fitted within a probe cover to tension a probe window independent of the insertion of a thermometer probe.

Therefore, it would be desirable to overcome the disadvantages and drawbacks of the prior art with a probe cover for an eardrum thermometer that improves the accuracy and reliability of temperature measurements, for example by reducing conductive heat transfer to the probe and / or reducing errors due to deformations in the film barrier covering the window. It would also be desirable for such a probe cover to be comfortable for the subject. Furthermore, it would be highly desirable for the probe cover to be designed to facilitate stacking (eg nesting) of many probe covers for ease of storage.

Summary of the invention

The present invention provides a probe cover for a probe of an eardrum thermometer according to claim 1. Preferred features of the invention are provided according to the dependent claims.

Brief description of the drawings

Figures 1 and 2 are perspective views of one embodiment of a probe cover of the present invention from different vantage points;

Figure 3 is a perspective view of the probe cover mounted on an eardrum thermometer;

Figure 4 is a cross section of the non-inventive probe cover in a plane through each of a pair of opposite end ribs of the probe cover;

Figure 5 is an enlarged view of a portion of the probe cover in cross section shown in Figure 4;

Figure 6 is an enlarged perspective view of a portion of the probe cover in cross section shown in Figure 4 including the distal end thereof;

Figure 7 is a cross section of a non-invention probe cover in a plane extending through a protrusion on the inside of the probe cover and a pair of serrations on opposite sides of the outside of the probe cover. ;

Figure 8 is an enlarged view of a portion of the probe cover in cross section showing the bisected protrusion in the area of ​​detail indicated in Figure 7;

Figure 9 is an enlarged view of a portion of the cross section of the probe cover including one of the serrations in the area of ​​detail indicated in Figure 7;

Figure 10 is a cross section of the probe cover mounted on an eardrum thermometer;

Figure 10A is an enlarged partial view of a distal end of the probe cover in cross section and of the thermometer shown in Figure 10;

Figure 11 is an enlarged view of a portion of the probe cover in cross section showing the area of ​​detail indicated in Figure 10;

Figures 12 and 13 are perspective views of another embodiment of a probe cover of the present invention from two different vantage points;

Figure 14 is a cross section of the probe cover shown in Figures 12 and 13 in a plane through a pair of opposite end ribs;

ES 2 337 488 T3 Figure 15 is an enlarged perspective view of the probe cover in cross section shown in the Figures

12-14 showing a distal end thereof;

Figure 16 is a cross section of the probe cover shown in Figures 12-15 mounted on a thermometer probe;

Figure 16A is an enlarged partial view of a distal end of the probe cover in cross section and thermometer shown in Figure 16;

Figure 17 is a perspective view of another embodiment of a probe cover of the present invention;

Figure 18 is a cross section of the probe cover shown in Figure 17 in a plane through each of a pair of opposite end ribs;

Figure 19 is an enlarged view of a portion of the probe cover in cross section shown in Figure 18 with a thermometer probe received therein showing one of the end ribs and a portion of a film holder in the area of detail indicated in Figure 18;

Figure 20 is a perspective view of yet another embodiment of a probe cover of the present invention;

Figure 21 is a cross section of the probe cover shown in Figure 20 in a plane through each of a pair of opposite end ribs; and Figure 22 is an enlarged perspective view of a portion of the probe cover in cross section shown in Figure 21 showing a distal end thereof.

Corresponding reference characters indicate corresponding parts throughout the drawings.

Detailed description

The exemplary embodiments of the probe cover and methods of use explained and discussed in terms of medical thermometers for measuring body temperature, and more particularly, in terms of a probe cover used with an eardrum thermometer that reduces unwanted heat transfer from the probe cover to an eardrum thermometer probe. Some embodiments of the invention can limit heat transfer from the probe cover to the probe of an eardrum thermometer, alleviate the problems associated with deformation of a film membrane used to provide a sanitary barrier, improve the comfort of a subject during measurement of body temperature; protect you against the spread of bacteria and disease; and / or facilitate health care practices aimed at the prevention, diagnosis and / or treatment of diseases, bodily ailments, and the like. Some embodiments of the invention facilitate the reliable and repeatable manufacture of probe covers, particularly as regards the attachment of an infrared transparent film to the end of the probe cover.

In the discussion that follows, the term “proximal” will refer to the part of a structure that is closest to a professional in normal use, while the term “distal” will refer to the part that is furthest from the professional in normal use. . As used herein, the term "subject" refers to a human or other animal patient whose temperature is being measured. The term "professional" refers to a physician, nurse, or other caregiver who uses an eardrum thermometer to measure a subject's body temperature and may include support personnel.

The disposable component parts of the probe cover are made from materials suitable for measuring body temperature through the eardrum with a device that measures the temperature of the eardrum. These materials can include, for example, plastic materials such as, for example, polypropylene, polyethylene, etc. The materials used may vary depending on the particular application and / or temperature preference of a professional's temperature measurement. For example, a body of the probe cover can be made from high-density polyethylene (HDPE).

The probe cover has a window or film portion that can be manufactured from a material substantially transparent to infrared radiation and impervious to moisture, ear wax, etc. The film, for example, can be made from low-density polyethylene (LDPE) and can have a thickness between 12.7 and 25.4 pm (0.0005 to 0.001 inches) although other ranges are contemplated. of measurements. The film can be semi-rigid or flexible, and can be formed monolithically with the remaining part of the probe cover or connected so that it is an integral part of it, for example by means of heat welding, stamping, etc. However, one skilled in the art would realize that other suitable materials and manufacturing methods for mounting and fabricating the probe cover would be appropriate and would not deviate from the scope of the invention as defined in the appended claims.

As an introduction to the probe covers of the invention shown in Figures 10-22, some embodiments of the probe covers which are not of the invention and which are illustrated in detail in Figures 4- will be described below in greater detail. 7 accompanying. Referring first to Figures 1-11, illustrated is a

ES 2 337 488 T3 embodiment of a probe cover, generally designated 20. The probe cover 20 defines a longitudinal axis X and has a generally tubular body 22, extending in a conical configuration from a proximal end 24 to an end distal 26. This design improves the comfort of a subject (not shown) during a temperature measurement procedure. The probe cover may be generally cylindrical, frusto-conical, or of any other conical or curved shape for insertion into the subject's ear without departing from the scope of the invention. Proximal end 24 defines an opening 28 configured for reception of a heat sensing probe 34 at a distal end of an eardrum thermometer 32, as shown in Figures 3 and 10. Heat sensing probe 34 is configured to detect infrared energy emitted by the subject's eardrum membrane.

The tympanic thermometer 32 may include a waveguide to facilitate the detection of thermal energy from the tympanic membrane.

A film 36 covers a window at distal end 26 of body 22. Film 36 is substantially transparent to infrared radiation and is configured to facilitate detection of infrared emissions by heat detector probe 34. For example, the film 36 may be substantially perpendicular to the longitudinal axis X of the body 22 to allow the passage of infrared radiation through the probe cover 20 generally in the direction of the longitudinal axis to the heat detection probe 34. Film 36 is preferably impermeable to ear wax, moisture, and bacteria, which can help prevent the spread of disease.

As shown in Figures 4-7, distal end 26 includes one or more end ribs 38 (eg, a plurality of end ribs as shown in the drawings) disposed around an inner circumferential surface 40 of tubular body 22. The end ribs 38 have a longitudinal portion 46 that extends near and along the inner circumferential surface 40 of the tubular body 22. A thickness a (Figure 5) protrudes from the longitudinal portion 46 and a length b extends along the inner surface 40. The end ribs 38 also have a transverse portion 50 that protrudes along a transverse surface 51 (i.e. , generally perpendicular to the longitudinal axis X) of the film 36. Dimensions a, b, c and d are selected to facilitate bearing and engagement of end ribs 38 with heat sensing probe 34 and to limit conductive heat transfer from the probe cover to the probe as described herein.

For example, in one embodiment of the invention dimension a is between 50.8 pm (0.002 inches) and about 0.127 mm (0.005 inches) (eg, about 76.2 pm (0.003 inches)), dimension b is between between about 0.89mm (0.035 inches) and about 2.54mm (0.100 inches) (eg, about 2.1mm (0.083 inches)); dimension c is from about 0.254mm (0.010 inches) to about 0.762mm (0.030 inches) (eg 0.432mm (0.017 inches)); and the dimension d is between about 0.178mm (0.007 inches) and about 0.508mm (0.020 inches) (eg, about 0.33mm (0.013 inches)). Those skilled in the art will understand that the dimensions above are exemplary and may vary substantially, especially in view of the fact that probe covers are often designed for use with a particular ear thermometer, and there is a substantial variation in the size and shape of eardrum thermometers. The dimensions of a probe cover designed for use with the same tympanic thermometer can also vary significantly without departing from the scope of the invention as defined in the appended claims. Guidance for sizing probe covers will also be found by those skilled in the art in this description.

The transverse portions 50 of the end ribs 38 engage the heat sensing probe 34 when the probe cover is positioned over it to prevent contact of the film 36 by the heat sensing probe 34. In this regard, the transverse portions 50 of end ribs 38 are spacers that keep heat sensing probe 34 separate from film 36. The dimension c (Figure 5) of the transverse portions 50 provide the necessary depth to maintain an air / fluid space or cavity 55 (Figures 10 and 10A) between the heat sensing probe 34 and the film 36. In one embodiment dimension c is selected so that the air gap 55 is between about 0.127mm (0.005 inches) and about 0.635mm (0.025 inches) thick (eg, about 0.432mm (0.017 inches) thick) at the distal end of thermometer probe 34. Similarly, the longitudinal portions 46 of the end ribs 38 engage the heat sensing probe 34 to prevent contact of the inner circumferential surface 40 of the body 22 with the heat sensing probe. In this way, the isolation air gap 55 between the distal end of the heat detector probe 34 and the probe cover extends close to and along the side of the heat detector probe between the probe and the end ribs 38. . Limiting the contact between the distal end of the heat detector probe 34 and the probe cover 20 thus reduces the possibility of unwanted heat transfer between the probe cover and the heat detector probe, allowing measurements to be taken. more accurate temperature.

The probe cover 20 is dimensioned to provide a tight fit with the heat detector probe 34. In particular, when the longitudinal portions 46 of the end ribs 38 fit into the heat detector probe 34 when the probe cover being placed over them, the heat detecting probe slightly deforms the end ribs 38 forcing them to separate from each other slightly at the distal end of the body 22. The spacing of the end ribs 38 at the distal end of the body is transmitted to the film 36, thereby stretching the film and causing it to become radially taut. This stretching reduces deformation (eg, wrinkling) of film 36 and allows for greater precision in temperature measurement.

ES 2 337 488 T3

The tubular body 22 has an outer circumferential surface 42 that includes a curved surface 44 contiguous with the distal end 26. The curved surface 44 curves inward toward the longitudinal axis X, thus improving comfort and facilitating insertion of the probe cover 20 in a subject's ear canal. The degree of inward curvature of curved surface 44 can be varied to suit the needs of a particular application or to suit a particular preference. Furthermore, a beveled or conical shape better than a curved surface could be used without departing from the scope of the invention as defined in the appended claims.

As shown in Figures 4 and 7, the body 22 defines one or more longitudinal ribs 52 (e.g., a plurality of longitudinal ribs as shown in the drawings) that protrude from the inner circumferential surface 40 and are spaced close to each other. distal end 26 of the body and end ribs 38. Longitudinal ribs 52 project a thickness e (Figure 7) from inner circumferential surface 40 and extend a length f along inner circumferential surface 40. For example, dimension e may be between about 0.381 mm (0.015 inches). and about 1.02mm (0.040 inches), and the dimension f may range from about 2.54mm (0.10 inches) to about 7.62mm (0.30 inches). Longitudinal ribs 52 each define a transverse face 57 that is configured to engage a protrusion of heat sensing probe 34 when probe cover 20 is placed thereon. Dimensions e and f are selected to configure longitudinal ribs 52 and transverse faces 57 thereof to facilitate releasable retention of probe cover 20 on heat detector probe 34. The transverse faces 57 of the longitudinal ribs 52 can be used as thrust surfaces of the ejection mechanism of a probe cover.

As shown in Figure 7, body 22 defines one or more interior protrusions 54 (e.g., a plurality of interior protrusions as shown in the drawings) that protrude from the interior circumferential surface 40 of body 22 and are spaced closely apart. from its distal end 26. The inner protrusions 54 shown in the drawings have spacing intervals and have an elliptical configuration having a width g (Figure 4) and a height h (Figure 8). Width g is greater than height h. The inner protrusions 54 have a radial curvature projecting a thickness i (Figure 8) from the inner circumferential surface 40 to be received in an annular groove 34a (Figure 10) formed in the probe 34. When the probe cover 20 is mounted on the thermometer probe 34 the protrusions 54 rest in the groove 34a and hold the probe cover 20 by preventing movement in the direction of the longitudinal axis X relative to the probe. Like end ribs 38 and longitudinal ribs 52, inner protrusions 54 help maintain air gap 55 between heat detector probe 34 and tubular body 22, thereby reducing unwanted heating of the heat sensing probe 34 by contacting the probe cover 20. The dimensions g, h and i can be adjusted if necessary to suit the size and shape of the annular groove of any particular thermometer. The body 22 also defines one or more serrations 56 (Figure 9) on the outer circumferential surface 42 thereof, which are spaced near the distal end 26 of the body.

The probe cover 20 includes a flange 58 disposed adjacent the proximal end 24 of the body (see Figure 1). The flange 58 extends around the circumference of the proximal end 24 of the body 22 providing strength and stability for mounting the probe cover 20 on the eardrum thermometer 32.

In use, the probe cover 20 is mounted on the heat sensing probe 34 (as shown in Figures 10 and 10A) and the film 36 is separated from a direct fit with the heat sensing probe by way of the space of air 55 held by the engagement of the end ribs 38 with the heat detector probe. Likewise, the air gap 55 extends along the side of the heat detector probe 34 in the spaces between the end ribs 38 and is held close to it by engaging the interior protrusions 54 and the proximal circumferential surface 40 of the longitudinal ribs 52 with the side of the heat detecting probe. Limited contact between probe cover 20 and heat sensing probe 34 and air gap 55, which serves as an insulating layer, reduces unwanted conduction heat transfer from probe cover to probe 34 and thus reduces distorted readings as well as thermal noise interference. Therefore, the probe cover 20 facilitates a more accurate temperature measurement.

To measure a subject's body temperature (not shown), a professional (not shown) gently pulls the subject's ear back to straighten the ear canal so that the heat sensing probe 34 can receive infrared emissions directly from the ear. tympanic membrane. The eardrum thermometer 32 is manipulated by the practitioner so that a portion of the probe cover 20, which is mounted on the heat sensing probe 34, is easily and conveniently inserted into the outer canal of the subject's ear. Heat sensing probe 34 is appropriately positioned to detect infrared emissions from the tympanic membrane that are indicative of the subject's body temperature. Infrared light emitted by the eardrum membrane passes through the film 36 towards the heat detector probe 34.

The eardrum thermometer 32 is manufactured to be reused, but the probe cover 20 is disposable. Therefore, after one use the probe cover 20 is discarded and another one of the probe covers has to be mounted over the heat sensing probe 34. Therefore, the probe covers 20 provide a sanitary barrier to the heat sensing probe 34 to reduce the spread of bacteria and disease. Other methods of use of the eardrum thermometer 32 and probe cover 20 are envisaged such as, for example, alternative placement and orientation, etc. without departing from the scope of the invention as defined in the appended claims.

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Embodiments of probe covers according to the present invention will now be described. An embodiment of the probe cover, generally designated 20a, is described with reference to Figures 12-16. Another embodiment of the probe cover, generally designated 20b, is also described with reference to Figures 17-19. Another embodiment of the probe cover, generally designated 20c, is also described with reference to Figures 20-22. Although the actual designs of the probe covers 20a, 20b, and 20c are in some respects different from the embodiment of the probe cover 20 described above, the materials and manufacturing processes used to make the probe covers 20a, 20b , and 20c may be substantially the same as described for probe cover 20 except where noted. In addition, probe covers 20a, 20b, and 20c can function in substantially the same way as probe cover 20, except as indicated. Whenever possible, reference numerals used to describe elements of probe covers 20a, 20b, and 20c are based on reference numerals used to describe similar elements of probe cover 20 with the letters "a" , "B", and "c", respectively, appended thereto.

Referring to Figures 12-16 the probe cover 20a comprises a tubular body 22a defining a longitudinal axis X and extending in a conical configuration from a proximal end 24a to a distal end 26a. Proximal end 24a defines an opening 28a configured to receive a distal end 30 of an eardrum thermometer 32, such as, for example, a heat sensing probe 34. The particular conical configuration shown in the drawings is believed to be comfortable for many subjects when inserted into the ear canal, but the tubular body may have a different configuration from the conical, either generally cylindrical or frusto-conical, without departing from the scope of the ear. invention. One or more end ribs 38a (eg, a plurality of end ribs as shown in the drawings) is disposed around an inner circumferential surface 40a of the tubular body 22a at its distal end 26a.

One difference between the probe cover 20a shown in Figures 12-16 and the probe cover 20 previously described is that a thermally shrinkable film 36a, which is substantially transparent to infrared radiation, is attached to the tubular body 22 at its location. distal end 26a. In contrast to the design of the probe cover 20, the probe cover 20a is designed to substantially prevent stretching of the film 36a upon receipt of the probe of the thermometer 34 at the opening 28a. Instead, the film 36a is taut by subjecting the probe cover 20a to a heat treatment that contracts the film 36a after the film has been insert molded into the distal end 26a of the probe 20a during the formation of the probe. Shrinkage of the film 36a during heat treatment absorbs the slack in the film and results in a film that is substantially free of wrinkles and other deformations that are a concern from a thermometer performance standpoint.

End ribs 38a are configured to engage heat sensing probe 34 and keep it separate from film 36a in substantially the same way as end ribs 38 do for probe cover 20 described above. In this way, end ribs 38a maintain an insulating air gap 55a between the distal end of thermometer probe 34 and film 36a (Figure 16). The air gap 55a also extends closely between the longitudinal portions 46a of the end ribs 38a. However, unlike the probe cover 20, there is sufficient clearance between the longitudinal portions 46a of the end ribs 38a and the thermometer probe 34, so that the end ribs 38a are not needed to separate in order to accommodate the thermometer probe. Although the probe cover 20a is configured such that there is no separation of the film 36a, it is understood that it is permissible to configure a probe cover to cause some stretching of a thermally contracted film upon receipt of the probe. 34 without departing from the scope of the invention as defined in the appended claims as long as the amount of stretch is within acceptable tolerance levels.

A film holder 45a is provided at the distal end 26a of the body 22a. The object of the film support 45a is to prevent stress concentrations at the boundary between the film 36a and the contact points of the film with the body 22 at its distal end from accumulating in the film 36a during the shrinkage process. thermal. For example, the end ribs 38 of the probe cover 20 protrude into the window (best seen in Figure 16) and cause the perimeter of the window to have the corners that rotate in the plane of the window. In other words, it is possible to move the corners defined by the end ribs 38 back and forth while always remaining in the plane of the window. If the probe cover film 36 20 were subjected to a heat shrink treatment, the corners of the end ribs 38 would undesirably concentrate stresses on the film, rendering the film highly vulnerable to tearing. The concentration of stresses in the end ribs 38 also introduces deformations (eg, wrinkles) in the film 36 that interfere with accurate temperature measurement. The film support 45a of the probe cover 20a has a distally facing film support surface 53a (Figure 15). In the embodiment shown in the drawings the film support surface 53a is generally perpendicular to the longitudinal axis X. The distal ends of the end ribs 38a may converge and be coplanar with the film support surface 53a, as shown in Figures 14 and 15, in which case the end ribs may be characterized as part of the film support surface. the movie. On the other hand, a film support can be other than the end ribs without departing from the scope of the invention. In some embodiments, the film holder 45a is formed as an integral part of a piece of material with the tubular body 22a and end ribs 38a.

Film support surface 53a extends circumferentially about longitudinal axis X at distal end 26a of body 22a. Film 36a is attached to film support surface 53a (Figure

ES 2 337 488 T3

16A). For example, film 36a may be attached to a film support surface 53a at a plurality of points (eg, a substantially continuous band of attachment points). Significantly, the film support surface 53a, particularly the inner edge 53a thereof, is substantially free of sharp corners and curvatures rotating in a plane of the window. The absence of sharp corners and curvatures at the inner edge 53a 'of the film support surface 53a enhances a more balanced tensioning of the film 36a during the thermal shrinkage process. This helps prevent wrinkling and tearing of the film 36a. In contrast, the film 36 of the probe cover 20 described above is attached to the generally distal rectangular surfaces of the inward projections 50 of the end ribs 38. The projections 50 have corners that can concentrate stresses on the film 36 and be the cause of wrinkles or tears in the film, especially if the film is subjected to thermal shrinkage.

When manufacturing probe covers in which a separate film is attached to the body of a probe cover, it is desirable to fix the film to the body while the body is still hot (for example, from an injection molding process) to facilitate the attachment of the film to the body. Another advantage of the film holder 45 is that it helps to reduce the deformations that can occur when the film 36a is attached to the body 22a while it is still hot. The end ribs 38a (like the end ribs 38 of the probe cover 20 described above) retain heat longer than other parts of the body 22a due to their greater relative mass. Therefore, the relatively hotter end ribs 38a can cause localized shrinkage of the film 36a upon contact with the film. Although they are not as hot as the end ribs 38a, the portions of the film support surface 53a extend between the end ribs and are hotter than the atmosphere. During manufacture of the probe cover 20a it reduces the temperature gradients experienced by the film 36a compared to the temperature gradients that would be encountered by the film 36 in the probe cover 20 described above, thereby reducing the effect of deformations resulting from local shrinkage of the film. The relatively larger surface area of ​​the film support surface 53a and its corner-free inner edge 53a 'also reduces the effect of any local shrinkage occurring in the film 36a by making it easier for the film to form a good seal with the film. body 22a moving the perimeter of the window in and out from the parts of the film that are most affected by local shrinkage.

As best seen in Figure 15, for example, the holder 45a of the probe cover 20a is a ring at the distal end 26a of the body 22a that extends along the inner circumferential surface 40a of the intermediate body 22a and coextensive with the distal ends of end ribs 38a. It will be understood that the ring may take various shapes other than circular without departing from the scope of the present invention as defined in the appended claims. The film holder 45a extends the same distance inward in the direction of the longitudinal axis X as the end ribs 38a. In this way, the inner edge 53a of the film holder 45a is smooth and continuous. The inner edge 53a 'of the film holder 45a is also substantially free of segments having an outward curvature. Furthermore, the inner edge 53a of the film holder 45a is substantially free of inward projections (eg, towards the longitudinal axis X). In the embodiment shown in Figures 16 and 16A the film support ring has an axial thickness L, which is less than the depth c of the inward projections of the end ribs 38a, allowing the insulating air gap 55a extends between the inward projections 50a of end ribs 38.

Therefore, the probe cover 20a supports consistent and accurate temperature measurements. In one embodiment the dimension L is between 50.8 µm (0.02 inches) and about 0.203 mm (0.008 inches) (eg, about 0.127 mm (0.005 inches)). The difference between dimension L and dimension c is preferably between about 0.178mm (0.007 inches) and about 0.381mm (0.015 inches) (eg, about 0.305mm (0.012 inches)).

Another difference between the probe cover 20a shown in Figures 12-16 and the probe cover 20 previously described is that the probe cover 20a has a continuous annular rim 152a instead of the plurality of circumferentially spaced longitudinal ribs 52. around the inner circumferential surface 40 of the probe cover 20. Annular rim 152a has a proximal front platform 157a and tapering distally from the platform to meet circumferential surface 40a of body 22a. The front platform 157a of the annular rim 152a can be used as a push surface for a probe cover ejection mechanism.

Referring now to Figures 17-19 and the embodiment of probe cover 20b shown therein, it is noted that probe cover 20b is substantially the same as probe cover 20a except at its distal end 26b. . The probe cover 20b comprises a curved surface 44b at the distal end 26a of the tubular body 20b; much like the previously described probe covers 20, 20a. However, the film holder 45b joins smoothly at the curved surface 44b and there is no edge or other boundary marking the transition of the outer circumferential surface 42b of the tubular body 22b and the film support surface 53b of the holder 45b. of the movie. In addition, film 36b, which is a heat-shrinkable film substantially similar to film 36a, is attached to and extends over a curved surface 44b at the distal end of probe cover 20b. Extending film 36b outward over curved surface 44b and attaching to it provides a greater surface area for greater bond strength between body 22b and film 36b. It also reduces the possibility of grooves and tears formed on the perimeter of the film 36b (for example, when cutting the film in a manufacturing process) to propagate far enough inward to allow contaminants to enter8.

ES 2 337 488 T3 train on the probe cover 20b through the film, or otherwise interfere with the proper operation of the probe cover.

The wall thickness along the curved surface 44b may gradually decrease as the curved surface extends toward the distal end 26b to transition from a thicker wall near the distal end to a thinner wall of the bracket. 45b from the film, as shown in the drawings. This allows the insulating air gap 55b to extend between the inward projections 50b of the end ribs 38b.

In other respects, the film holder 45b is essentially the same as the film holder 45a described above. In particular, the inner edge 53b 'of the film holder 45b is substantially the same as the inner edge 53a' of the film holder 45a of the probe cover 20a and reduces stress concentrations when the film 36b is thermally contracted. and the problems associated with it in substantially the same way.

Referring now to Figures 20-22 and the embodiment of the probe cover 20c shown therein, it is noted that the probe cover 20c is substantially the same as the probe cover 20a shown in Figures 13-16 except for I warned you. A difference between the probe cover 20c and the probe cover 20a is best seen by comparing Figures 22 and 15. Referring first to Figure 15, the inner edge 53a 'of the film holder 45a is flush with the inward faces of the inward projections 50a of the end ribs 38a. In contrast, the inner edge 53c 'of the film holder 45c shown in Figure 22 extends further inward than the end ribs 38c. For example, the film support 45c can be configured to have a distal front generally flat film support surface 53c having a width m of between 0.178 mm (0.007 inches) and about 0.508 mm (0.020 inches) (for example , approximately 0.432 mm (0.017 inch)). This provides a greater surface area for bonding the film 36c to the film backing 45c. For example, the area of ​​the distal front film support surface 53c of the film holder 45c may be between about 6.45mm² (0.01 sq. In.) And approximately 12.9 mm²(0.02 square inches). In one embodiment the area of ​​the distal front film support surface 53c is at least about 20% of the total area of ​​the window defined by the inner edge 53c 'of the film support 45c. Generally, the larger the distal front surface in all embodiments the more bonding area will be provided for the film. This feature also decreases the opportunity for quality defects that can occur during the molding of the probe covers. Particularly during release from the mold there is a possibility of the film tearing or stitches forming. Although this can occur in manufacturing, the chances of them rendering the probe cover of a lower quality are reduced due to the larger bonding surface provided by the film backing.

In contrast, the film holder 45a shown in Figure 15 does not extend so far towards the longitudinal axis X out of danger (which is common in the art) that the probe cover 20a may block some of the field generally vision cone from an IR sensor (not shown) on probe 34 of the thermometer. In contrast, in the embodiment shown in Figures 20-22 the inventors have extended the film holder 45c far enough inward so that the inner edge 53c 'of the film holder 45c that defines the perimeter of the window Rest very close to the field of view of the IR sensor (broadly speaking, an electromagnetic radiation sensor).

Referring to Figure 22, for example, the intersection of the periphery of the field of view of an IR sensor at probe 34 (not shown in Figure 22) with film 36c is indicated by a dotted line 61c. Because the inner edge 53c of the film holder 45c is configured to extend further inward and invade (without entering) the IR sensor's field of view, there is relatively less annular space (designated 63c in Figure 22) between the inner edge 53c of the film holder 45c and the field of view of the IR sensor in the window. For example, annular space 63c preferably has a width that is less than about 1.27mm (0.050 inches). Annular space 63c preferably has an area that is less than about 60% of the area of ​​the window. In one embodiment the annular space has an area that is less than 51% of the area of ​​the window, in one embodiment the area of ​​the annular space is approximately 9% of the area of ​​the window.

The probe cover 20c functions in substantially the same way as the other probe covers 20, 20a and 20b described in detail herein. However, any grooves, tears, or other damage to the 36c film caused during cutting of the film in manufacturing are less likely to spread across the window or otherwise interfere with the temperature measurement due to the increased distance. they should have to spread to reach the window from the edge of the film.

Those skilled in the art will recognize that the embodiments described above are exemplary of the invention and that there is room for substantial variation in probe cover design within the scope of the invention as defined in the appended claims. In particular, the size, shape, and / or configuration of the probe cover can be modified to achieve the advantages of the invention from virtually any eardrum thermometer available. Also, the size, shape, and / or configuration of the body, curved surface, window, end ribs, film holder, and / or other elements of the probe cover can be modified from the sizes, shapes, and configurations described herein and shown in the drawings to accommodate various preferences for style, comfort, and / or other design criteria within the scope as defined by the appended claims.

ES 2 337 488 T3

Therefore, it will be understood that various modifications can be made to the embodiments discussed herein within the scope as defined by the appended embodiments. Therefore, the foregoing description should not be construed as limiting, but only as an exemplification of the various embodiments within the scope as defined by the appended claims.