CN111629644A - Body evaluation apparatus - Google Patents

Abstract

In a physical assessment device, an instrument head is provided for attachment to a plurality of instrument handles having different power profiles. The instrument head includes an illumination assembly including at least one LED and a drive circuit for detecting a power profile of an attached instrument handle and converting a variable voltage received from the attached instrument handle to a constant current to power the at least one LED based on the power profile. Thus, the instrument head can be used with a plurality of instrument handles, including those originally configured for use with only incandescent light sources.

Description

Body evaluation apparatus

Cross Reference to Related Applications

The present application claims priority from U.S. patent application serial No.16/248,482 entitled "body assessment device" filed on 15/1/2019 and U.S. patent application serial No.62/617,929 entitled "body assessment device" filed on 16/1/2018. The entire contents of the above application are incorporated herein by reference.

Technical Field

The present application relates generally to the field of diagnostic medicine and more particularly to an improved body assessment device (e.g., otoscope or ophthalmoscope) configured for performing diagnostic patient examinations.

Background

Body evaluation devices are well known in the diagnostic medical arts for examining patients as part of a health visit and/or routine examination. These devices include, among other things, otoscopes for diagnosing ear conditions, ophthalmoscopes for diagnosing conditions associated with the eyes of a patient, and dermoscopes for examining the skin of a patient. Each of these physical evaluation devices typically includes an instrument head releasably attached to the upper end of an instrument handle containing a set of batteries, making the device compact and capable of being operated with one hand. The instrument head may hold optics that enable an image of the medical target (e.g., ear, eye) to be viewed by a caregiver through the eyepiece, or alternatively, the image of the medical target may be transmitted to an electronic imager associated with the physical evaluation device. Appropriate illumination of the medical target of interest is provided by a resident light source (e.g., an incandescent lamp).

There is a general need in the field of diagnostic medicine to improve physical evaluation devices such as those described above.

Disclosure of Invention

According to a first aspect, there is provided an instrument head for attachment to a plurality of instrument handles having different power profiles. The instrument head includes: a lighting assembly comprising at least one LED; and a drive circuit for detecting a power curve of the attached instrument handle and converting a variable voltage received from the attached instrument handle to a constant current to power the at least one LED based on the power curve.

The drive circuit outputs Pulse Width Modulation (PWM) of the constant current to illuminate the at least one LED, wherein dimming of the at least one LED is achieved by varying the PWM duty cycle of the constant current in response to changes in the variable voltage received from the attached instrument handle.

In one form, the drive circuit outputs a constant current PWM to power the LEDs at a given illumination level when the drive circuit is connected to a first instrument handle of the plurality of instrument handles having a first power curve and a first variable voltage or a second instrument handle of the plurality of instrument handles having a second power curve and a second variable voltage, wherein the first power curve and the second power curve are different power curves.

According to another form, the drive circuit includes a buck/boost circuit that outputs a constant voltage even if the input voltage from the instrument handle is higher or lower than the constant voltage.

The drive circuit may include a rectifier including a Field Effect Transistor (FET) for converting ac power input from the instrument handle to dc power for powering the at least one LED.

In at least one form, the drive circuit includes a controller, wherein the controller detects a polarity of an instrument handle attached to the instrument head. The controller may detect a vibrational or idle state of the instrument head and, in response, may power the instrument head on or off. In at least one form, the controller uses a look-up table to determine a power curve for the instrument handle based on the power signal received at the time of attachment.

According to a preferred embodiment, the instrument head is part of a physical evaluation device. More specifically, the physical assessment device is an otoscope or ophthalmoscope, wherein at least one of the instrument handles used with the instrument hand is typically configured for use with only an incandescent light source.

According to another aspect, there is provided a physical assessment device comprising an instrument head attached to an instrument handle, wherein the instrument head has a distal end and an opposite proximal end. The illumination assembly arranged inside the instrument head comprises at least one LED as light source. An optical assembly is also disposed inside the instrument head and includes a plurality of optical components aligned along an imaging axis. For examination purposes, an accessory attached to the distal end of the instrument head is used for interfacing with the patient, wherein the optical assembly produces an entrance pupil that is sufficiently distant from the most distal optical element of the imaging assembly that the attached accessory is not within the field of view of the optical assembly.

In at least one form, the attached accessory is a speculum tip and the body evaluation device is an otoscope, wherein the speculum tip is cropped from the resulting image of the patient's ear canal due to the location of the distal entrance pupil. The optical assembly allows the entire tympanic membrane to be viewed in the field of view at one time.

The instrument head may include a pair of mating housing portions defining an instrument head interior, an inner former disposed within the interior, and a sealing member attached to the inner former to allow insufflation of a patient. According to at least one form, the sealing member is resilient and is attached to the proximal end of the inner former. Advantageously, the sealing member also provides an anti-fogging measure with respect to at least one optical component of the optical assembly.

According to another aspect, a lighting assembly includes an LED attached to a circuit board, and a component that centers and aligns the LED with respect to a defined lighting axis. The centering and alignment feature may include a domed surface configured to receive and collimate light from the LED.

According to one form, the centering and alignment feature includes an annular ring that centers the dome surface with respect to the LED, and the dome surface is a condenser lens. Advantageously, according to at least one form, the annular ring may include an externally threaded portion that provides a barrier to dirt and debris for the LED.

The illumination assembly may be used in a physical assessment device that is at least one of an otoscope or an ophthalmoscope. Preferably, the instrument head is attachable to an instrument handle having at least a power source for energizing the LED. According to one form, the instrument head is attachable to one of a different number of instrument handles, including instrument handles configured to supply power to a lighting assembly having an incandescent lamp as a light source. The circuit board may include circuitry configured to allow any of a variety of instrument handles to be attached to the instrument head and to power the LED without causing it to blink.

According to another aspect, a physical assessment device is provided that includes an instrument head having a distal end, an opposite proximal end, and an interior. An optical assembly is disposed within the instrument head and includes a plurality of optical components disposed along an optical axis. Additionally, an adapter interface member is disposed at the proximal end of the instrument head. The adapter interface member enables an accessory of the smart device to be attached and aligned with the optical axis.

In at least one form, a smart device adapter is releasably engaged with the adapter interface member, the smart device adapter having a surface sized and configured to receive a smart device.

According to at least one embodiment, the adapter interface member includes a distal end, a proximal end, and a recess between the distal end and the proximal end. At least one optical component of the optical assembly may be retained in the adapter interface member.

In at least one form, the smart device adapter includes a device engagement portion formed from a plurality of engagement surfaces engageable with the recess of the adapter interface member. The recess of the adapter interface member may include a plurality of machined flats engageable with the engagement surface of the smart device adapter. In accordance with at least one form, a smart device adapter includes a slot including a device engagement portion. The device engagement portion may include three engagement surfaces including two parallel engagement surfaces having a defined spacing and a third engagement surface orthogonal to the two parallel engagement surfaces, the three engagement surfaces forming an open clevis. According to at least one embodiment, one of the two parallel engagement surfaces is part of a sliding member that biases the engagement surface into the adapter slot.

The distal end of the adapter interface member may include a plurality of axial openings, wherein each axial opening retains a ball or similar feature biased into the recess and configured to axially engage the smart device adapter when attached. The machining of the recess of the adapter interface member also enables the smart device adapter and attached smart device to be selectively placed in a plurality of orientations about the optical axis of the physical assessment device.

In accordance with at least one form, the smart device adapter includes a slot sized and configured to receive the device engagement member. According to certain embodiments, the device engagement member comprises an adhesive tape on one side that is attachable to the smart device, and the opposite side of the device engagement member comprises a lateral groove.

The smart device adapter may include a detent member that is engageable with a transverse groove of the device engagement member when attached through the slot. In at least one embodiment, the detent member is disposed within a detent cover that is supported within a slot of the smart device adapter, wherein the detent member is biased by a spring supported by the detent cover.

The band of insulating material supported on the inner surface of the supported pawl cover is configured to provide resistance to the device engagement member when the device engagement member is attached to the smart device adapter via the slot. The smart device adapter includes an opening at the device interface that is aligned with an optical axis of the optical assembly when attached to the physical assessment device.

According to another aspect, a smart device adapter for a physical assessment device is provided. The adapter includes an adapter housing including a proximal watch sized and shaped to support the smart device, and a device engagement portion sized and configured to releasably engage the body evaluation device. A smart device engagement member having at least one feature enables releasable attachment to a smart device.

According to one form, the device engagement portion includes an arm extending from the adapter housing, the arm being suitably shaped and configured to engage a lower end of an instrument head of the physical assessment device. The arm may include an annular engagement portion sized to engage on the lower end of the instrument head, the arm being made of an elastomeric material. In at least one form, the device engagement portion includes a C-shaped engagement feature at the lower end of the adapter housing that is sized and shaped to snap-fit with a cylindrical handle of the physical assessment device.

According to another form, the device engagement portion is configured to engage the adapter engagement member at a proximal end of the body assessment device. The adapter may include a detent member engageable with the smart device engagement member when the smart device engagement member is attached to the adapter housing via the slot. The pawl member is supported by the pawl cover and is biased outwardly into the slot by a spring supported by the pawl cover.

According to another aspect, there is provided a smart device adapter for a physical assessment device, the smart device adapter comprising: a pair of housing portions defining an interior; a device engagement portion sized and configured to releasably engage a proximal end of a body evaluation device; and a smart device engagement member configured to releasably engage a slot of one of the housing portions and having at least one feature releasably attachable to a smart device.

In at least one embodiment, one of the housing portions includes a slot sized and configured to receive the smart device engagement member.

The adapter may include a detent member extending through the slot and engaging the smart device engagement member. According to at least one form, one side of the smart device engagement member includes an adhesive tape on one side engageable with the smart device. The lateral grooves of the opposing side may engage with the pawl member when the smart device engagement member is attached to the slot of the adapter.

A detent member is supported within a detent cover inside the adapter housing, the detent member being biased outwardly into the slot by a spring. According to at least one form, the device engagement portion includes a plurality of engagement surfaces formed in a slot-type configuration that enables releasable attachment to an adapter engagement member of the body assessment device. One of the engagement surfaces may be biased inwardly relative to a slot-type arrangement of the device engagement portion, and wherein the biased engagement surface is an edge surface of a slide member whose position is spring biased relative to the slot-type arrangement.

The smart device adapter also includes an opening formed in the adapter housing that is aligned with the optical component of the attached smart device.

According to another aspect, an ophthalmic apparatus is provided that includes an instrument head having a distal end and an opposing proximal end. An illumination assembly is disposed within the instrument head and includes at least one light source for illuminating a medical target of interest and a pair of fixation lights disposed in spaced relation at a distal end of the instrument head.

In at least one embodiment, a plurality of optical fibers extend from the at least one light source to the fixation lamp. The optical assembly includes an objective lens disposed at a distal end of the instrument head, wherein the fixation lamp is disposed distally relative to the objective lens.

According to a preferred embodiment, the at least one light source is an LED, wherein the fixation lamp comprises a polarizer window arranged in spaced relation. The ophthalmic device may also receive an elastomeric eye shield at a distal end thereof adjacent the fixation light.

According to another aspect, a physical assessment device is provided that includes an instrument head having a distal end, an opposite proximal end, and an interior. An illumination assembly is disposed within the instrument head and includes at least one light source and a plurality of components aligned along a defined illumination axis. The lighting assembly also includes a reflector that directs light from the at least one light source and at least one feature that enables adjustment of the reflector.

According to at least one embodiment, the body evaluation device comprises a mirror support base holding a mirror. The adjustment member is preferably accessible through the housing of the instrument head during manufacture, the adjustment member engaging the mirror mount to adjust the position of the mirror relative to the illumination axis.

In accordance with at least one form, the light source is an LED, wherein the lighting assembly further comprises a condenser lens disposed over the LED. The condenser lens is disposed in a component having features that align and center the condenser lens with the LED along the illumination axis. According to at least one form, the condenser lens is formed as a molded dome portion or surface on the alignment and centering member.

One advantage achieved by the body assessment device described herein is that a smart device, such as a smartphone, may be mechanically and optically coupled to a device, such as an otoscope or ophthalmoscope, which is typically only configured for optical observation by a caregiver.

Another advantage is that multiple accessories, such as speculum tip elements with different engagement features, can be releasably and interchangeably attached to an otoscope made in accordance with at least one embodiment.

Another advantage is that, according to at least one embodiment, the smart device can be attached to an existing body assessment device without change, such that the optical axis of the attached smart device is aligned with the optical axis of the body assessment device.

Another advantage is that an instrument head according to the present invention can be interchangeably attached to multiple instrument handles, wherein the instrument head is configured to detect the attached handle and adjust the held light source appropriately.

Another advantage achieved is that the optical system of the physical evaluation device enables attachment of an accessory, such as a speculum tip, which is not part of the field of view of the intended medical target.

These and other features and advantages will become apparent from the following detailed description, which is to be read in connection with the accompanying drawings.

Drawings

Fig. 1(a) is a side view of a body evaluation device made in accordance with an embodiment;

FIG. 1(b) is a front perspective view of the body evaluation device of FIG. 1 (a);

fig. 2(a) is a side view of an instrument head of the body evaluation device of fig. 1(a) and 1 (b);

FIG. 2(b) is a cross-sectional side view of the instrument head of FIGS. 1(a) -2 (a);

FIG. 2(c) is a rear view of the instrument head of FIGS. 1(a) -2 (b);

FIG. 2(d) is a rear perspective view of the instrument head of FIGS. 1(a) -2 (c);

FIG. 2(e) is another rear perspective view of the instrument head of FIGS. 1(a) -2 (d);

FIG. 2(f) is a side perspective view of the instrument head of FIGS. 1(a) -2 (e);

FIG. 2(g) is another side perspective view of the instrument head of FIGS. 1(a) -2 (f);

FIG. 2(h) is a bottom view of the instrument head of FIGS. 1(a) -2 (g);

FIG. 2(i) is a top view of the instrument head of FIGS. 1(a) -2 (h);

FIG. 2(j) is a left side view of the instrument head of FIGS. 1(a) -2 (i);

FIG. 2(k) is a right side view of the instrument head of FIGS. 1(a) -2 (j);

FIG. 3 is an exploded assembly view of the instrument head of FIGS. 1(a) -2 (k);

fig. 4 is an exploded view of the lens barrel mounted within the instrument head of fig. 1(a) -3;

FIG. 5(a) is a side perspective view of an instrument head according to an alternative embodiment;

FIG. 5(b) is a cross-sectional side view of the instrument head of FIG. 5 (a);

FIGS. 6 and 7 are exploded assembly views of a smart device adapter made in accordance with an exemplary embodiment;

FIG. 8(a) is a front view of the smart device adapter of FIGS. 6 and 7;

FIG. 8(b) is a cross-sectional view of the adapter taken through line 8-8 of FIG. 8 (a);

FIG. 9(a) is a rear view of the smart device adapter of FIGS. 8(a) and 8 (b);

FIG. 9(b) is a side view of the smart device adapter taken through section line 9-9 of FIG. 9 (a);

FIGS. 10(a) -10(e) illustrate sequential assembly flow diagrams of the smart device adapter of FIGS. 6-9 (b);

FIG. 11(a) is a partial cross-sectional view of a smart device adapter with an attached device engagement member;

FIG. 11(b) is a partial rear perspective view of the smart device adapter of FIGS. 6-11 (a);

FIG. 11(c) is a left side view of the smart device adapter of FIGS. 6-11 (b);

FIG. 11(d) is a right side view of the smart device adapter of FIGS. 6-11 (c);

FIG. 11(e) is a front view of the smart device adapter of FIGS. 6-11 (d);

FIG. 11(f) is a rear view of the smart device adapter of FIGS. 6-11 (e);

FIG. 11(g) is a top view of the smart device adapter of FIGS. 6-11 (f);

FIG. 11(h) is a bottom view of the smart device adapter of FIGS. 6-11 (g);

FIG. 11(i) is a front perspective view of the smart device adapter of FIGS. 6-11 (h);

FIG. 11(j) is a bottom perspective view of the smart device adapter of FIGS. 6-11 (i);

FIG. 11(k) is a rear perspective view of the smart device adapter of FIGS. 6-11 (j);

FIG. 11(l) is another bottom view of the smart device adapter of FIGS. 6-11 (k);

fig. 12(a) is a left side view of a device engagement member according to an embodiment;

FIG. 12(b) is a front view of the device engaging member of FIG. 12 (a);

FIG. 12(c) is a rear view of the device engaging member of FIGS. 12(a) and 12 (b);

FIG. 12(d) is a top view of the device engaging member of FIGS. 12(a) -12 (c);

fig. 12(e) is a bottom view of the device engaging member of fig. 12(a) -12 (d);

FIG. 12(f) is a front perspective view of the device engaging member of FIGS. 12(a) -12 (e);

FIG. 12(g) is a rear perspective view of the device engaging member of FIGS. 12(a) -12 (f);

FIG. 12(h) is another rear perspective view of the device engaging member of FIGS. 12(a) -12 (g);

fig. 13(a) is a partial side view of the smart device adapter of fig. 6-11(1) and the device engagement member of fig. 12(a) -12(h) assembled to the physical assessment device of fig. 1(a) -5;

fig. 13(b) is a side cross-sectional view of the instrument head of fig. 2(b) -2(k), the smart device adapter of fig. 6-11(1), and the device engagement member of fig. 12(a) -12(h), further illustrating a light ray trajectory of an optical system or assembly, the fiber trajectory including a distal entrance pupil produced by the optical system;

FIG. 14 is a partially assembled rear perspective view of a known physical evaluation device having a smart device adapter, which is made in accordance with another embodiment;

FIG. 15 is an exploded assembly view of the smart device adapter of FIG. 14;

FIG. 16 is a front perspective view of the body evaluation device of FIG. 14 assembled with the smart device adapter of FIG. 15 prior to being releasably attached to the smart device;

FIG. 17 shows a prior art physical assessment device (on the left) and the physical assessment device of FIGS. 1-5(b) in a side-by-side relationship;

FIG. 18 is a side perspective view of a prior art body assessment device with an attached smart device adapter, made in accordance with another embodiment;

FIG. 19 is another perspective view of a prior art physical evaluation device and the smart device adapter of FIG. 18;

FIG. 20 is a front perspective view of the smart device adapter of FIGS. 18 and 19;

FIG. 21 is a perspective view of a physical evaluation device made in accordance with another embodiment;

FIG. 22 is a perspective view of a physical evaluation device made in accordance with another embodiment;

FIG. 23 is a rear perspective view of the instrument head of the body assessment device of FIG. 21;

fig. 24(a) is a perspective view of the instrument head of the physical evaluation device of fig. 22;

FIG. 24(b) is a rear perspective view of the instrument head of FIG. 24(a) including an attached smart device;

FIGS. 25(a), 25(c) and 25(d) are partial assembled views of the instrument head of FIGS. 21 and 23, and FIG. 25(b) is an assembled view of the instrument head of FIGS. 21 and 23;

FIGS. 26(a) and 26(b) are partial assembled and assembled views of the instrument head of FIGS. 22 and 24 (a);

FIG. 27 is a cross-sectional front view of the instrument head of FIGS. 21, 23 and 25(a) -25 (d);

FIG. 28 is a cross-sectional front elevational view of the instrument head of FIGS. 22, 24(a) and 26 (b);

FIG. 29 is a perspective view of an instrument head for a body assessment device made in accordance with another embodiment;

FIG. 30 is a perspective view of an instrument head for a physical assessment device according to another embodiment;

FIG. 31 is a perspective view of the intermediate assembly band of FIGS. 29 and 30 used in the instrument head;

FIG. 32 is a partial cross-sectional view of the bottom of the instrument head showing the intermediate assembly strap of FIG. 31 secured to the instrument head;

fig. 33 is a partial perspective view of an instrument head of the physical evaluation device according to an embodiment;

FIG. 34 is an enlarged cross-sectional view of a portion of the instrument head of FIG. 33 including integral components of the illumination assembly for centering the received LED and collimating light emitted from the LED;

FIG. 35 is a top perspective view, partially in section, showing the integrated component of FIG. 34 within the instrument head relative to the remaining LEDs;

FIG. 36 is a top perspective view of the integrated component of FIGS. 34 and 35;

FIG. 37 is a cut-away side view of the body evaluation device of FIG. 21;

fig. 38 is an enlarged front view of the top of the instrument handle of the physical evaluation device according to an embodiment;

FIG. 39 is a bottom perspective view of the instrument head configured to engage the instrument handle of FIG. 38;

FIG. 40 is an enlarged portion of the instrument head of FIG. 39;

FIG. 41 is a partial cross-sectional view of the body evaluation device of FIG. 37, showing engagement between the instrument head and the instrument handle;

FIG. 42 is an enlarged view of a portion of FIG. 41;

FIG. 43 is an enlarged portion of the instrument handle of FIG. 38;

fig. 44 is a front view of an instrument handle for a physical assessment device according to an embodiment;

FIG. 45 is a partial cross-sectional view of the instrument handle of FIGS. 37 and 38;

FIG. 46 is a partial cross-sectional view of the instrument handle of FIGS. 37 and 45, illustrating aspects of a varistor assembly in accordance with an embodiment;

figure 47 is a perspective view of a detent ring member of the varistor assembly of figure 46;

FIG. 48 is a perspective view of an instrument handle made in accordance with another embodiment;

FIG. 49 is a partial cross-sectional view of the instrument handle of FIG. 48, showing a USB charging port;

FIG. 50 is a cross-sectional view of the instrument handle of FIGS. 48 and 49 showing battery charging contacts;

FIG. 51 is the cross-sectional view of FIG. 50, showing engagement of the instrument handle with the charging base or cradle;

FIG. 52 is a perspective view of a charging base or cradle having a pair of physical evaluation devices attached thereto;

FIG. 53 is a cross-sectional view of an instrument handle including features for detecting overheating of a housed battery;

fig. 54(a) shows an optical layout of the body evaluation device of fig. 13 (b);

figure 54(b) shows a comparison of the layout between the optical components and other forms of known body assessment apparatus according to various embodiments of the present invention;

fig. 55 illustrates the beneficial effects of the optical assembly of the invention of fig. 54(a) and 54(b) with respect to the attachment accessory of the body assessment device, compared to existing optical assemblies;

FIG. 56 is a layout of an alternative optical system defined as having a glass component instead of a plastic molded component;

57(a) and 57(b) are side perspective views of a body evaluation device made in accordance with another embodiment;

FIG. 58 is an exploded view of the instrument head of the body assessment device of FIGS. 57(a) and 57 (b);

FIG. 59(a) is a side view in cross-section of the instrument head of FIG. 58, further illustrating the ray traces of the housed optical components;

FIG. 59(b) is a cross-sectional side view of the instrument head of 59(a) further illustrating the light ray traces of the housed illumination assembly;

FIGS. 60(a) -60(d) are various views of the adjustable mirror mount assembly of the instrument head of FIGS. 58-59 (b);

FIG. 61 is a side view of a physical evaluation device made in accordance with another embodiment;

FIG. 62 is a partial front perspective view of a body assessment device with an attached smart device;

FIG. 63 is a front perspective view of the instrument head of the physical assessment device of FIG. 62 including an attached eye shield;

FIGS. 64(a) and 64(b) are side views in cross-section of the eye shield of FIG. 63 having a disposable annular member in accordance with an embodiment;

FIG. 65 is a cross-sectional view of an instrument head of a physical assessment device according to another embodiment;

FIG. 66 is an overall schematic view of the optical and illumination assemblies of the body evaluation device of FIG. 65;

FIG. 67 is a light ray trace diagram of the illumination assembly of the body evaluation device of FIGS. 65 and 66;

FIG. 68 is a light ray trace diagram of the optical components of the body evaluation device of FIGS. 65-67;

FIG. 69 is a front view of the distal end of the instrument head of FIG. 65, showing a pair of spaced apart fixed target illuminators;

FIG. 70 is an enlarged cross-sectional view of the lower portion of the instrument head of FIG. 65;

FIG. 71(a) is an enlarged cross-sectional view of a portion of FIG. 65;

fig. 71(b) is a perspective view of the mirror support member of fig. 71 (a);

figures 72(a) and 72(b) are perspective views in partial cross-section of a portion of an optical assembly including the rotatable diopter wheel of the instrument head of figures 65-67;

FIG. 73 shows a contrasting layout of a pair of optical assemblies for a physical assessment device;

FIG. 74 shows a body evaluation device having the optical assembly shown in FIG. 73;

FIG. 75 illustrates various light ray traces of a lighting assembly according to an embodiment compared to a prior lighting assembly;

fig. 76(a) and 76(b) illustrate an instrument head typically used for ophthalmic examinations, wherein the instrument head may be configured for otological examinations according to an exemplary embodiment;

fig. 77 is a block diagram of circuitry for controlling LED illumination in an instrument head, according to an embodiment;

fig. 78 is a flow chart illustrating a method for controlling LED illumination in an instrument head, according to an embodiment;

FIG. 79 is a circuit diagram of the controller of FIG. 77;

fig. 80 is a circuit diagram of the power conversion circuit of fig. 77;

FIG. 81 is a circuit diagram of the FET full wave bridge circuit of FIG. 77;

FIG. 82 shows a circuit diagram of a Field Effect Transistor (FET) rectifier/bridge according to another embodiment;

fig. 83(a) and 83(b) show an LED driving circuit diagram according to another exemplary embodiment;

FIG. 84 illustrates an electrical circuit that enables charging of an instrument head using a charging base or via USB, according to another embodiment;

85(a) and 85(b) are circuit diagrams that will drive both the LED and halogen-based lamp with a single varying power supply and maintain loop stability so that there is no risk of LED flicker; and

fig. 86 is a schematic diagram of a boost circuit made in accordance with an embodiment.

Detailed Description

The following relates to various embodiments of a physical evaluation device for examining a patient in general, and more particularly to an otoscope for examining a patient's ear in general and an ophthalmoscope for examining a patient's eye in general. From the description below, it will be apparent to the reader that many of the features described herein may be incorporated into physical evaluation devices other than those described. In addition, many of the features of the invention described are not limited to any particular embodiment, but are equally applicable to other described embodiments/devices. In addition, in order to provide a proper reference with respect to the drawings, a number of terms are used throughout the following description. These terms include "first," "second," "upper," "lower," "left," "right," "above," "below," "distal," "proximal," "inner," "outer," "inner," and "outer," and in particular, are not intended to limit any described inventive aspects unless specifically and explicitly indicated. Additionally, for clarity, like reference numerals are used throughout the discussion of the various embodiments.

Furthermore, the provided figures are intended to illustrate the salient features of the physical evaluation devices described herein. However, unless indicated to the contrary, the drawings are not intended to provide a scalar relationship between the various components described.

Otoscope

A first body assessment device (otoscope) is described. Fig. 1(a) and 1(b) show a side view and a front perspective view, respectively, of a body evaluation device, which according to this embodiment is an otoscope 100. Otoscope 100 is primarily designed for diagnostic examination of a patient's ear, although the body assessment apparatus 100 described herein may also be used to examine other anatomical cavities (i.e., nose, throat) of a patient. Otoscope 100 is defined by an instrument head 104 that is releasably attached to the upper end of an instrument handle or handle portion 108. The instrument handle 108 is sized and shaped to allow the otoscope 100 to be held in hand, and is also configured to hold at least one battery (not shown in these views) for powering a light source (not shown) housed within the instrument head 104. The housed light source is powered by a switch button 118 disposed on the exterior of the handle portion 108, wherein the illumination output of the housed light source may be controlled using a rheostat 117, the rheostat 117 comprising a twistable portion formed on the handle portion 108. The housed batteries are preferably charged via a charging port 119 provided at the bottom end of the handle portion 108.

As shown in fig. 2(a), the instrument head 104 according to this embodiment is defined by a body or housing having a distal or patient end 112 and an opposite proximal or caregiver end 116. A hollow speculum tip element 120 is releasably attached to the distal end 112 of the instrument head 104, the speculum tip element 120 being designed and shaped to fit a predetermined distance into the ear canal, while the proximal end 116 of the instrument head 104 includes an adapter interface member 180.

The interior of the instrument head 104 is substantially hollow and is sized and configured to hold a plurality of components. Referring to fig. 2(a) -2(k) and 3, and in accordance with this exemplary embodiment, instrument head 104 includes a pair of mating housing portions, specifically, a front housing portion 130 and a rear housing portion 134. Each housing portion 130, 134 is a shell-like structure made of a structural material such as moldable plastic. According to this embodiment, each housing portion 130, 134 is mated to one another using fasteners 136 as shown in FIG. 3, the fasteners 136 defining an interior cavity. Alternatively, the housing portions 130, 134 may be secured by welding (e.g., ultrasonic welding or other suitable means). As discussed in more detail in the later sections of this description, the lower end 131, 135 of each housing portion 130, 134 is retained at the bottom of the instrument head 104 by a retaining ring 280. According to this embodiment, a peripheral bumper 137 is disposed between the front and rear housing portions 130, 134. An inner former 138 disposed inside the front housing portion 130 includes a conical distal end 139 and a lower portion 141. The inner former 138 is substantially hollow and defines an internal cavity of the instrument head 104 to enable insufflation via a port connector (not shown) which extends outwardly to a corresponding access opening 114 as shown in figure 1(b), the access opening 114 being formed in the front housing portion 130.

Referring to fig. 2(b) -4, otoscope 100 described herein holds an optical assembly that includes a hollow barrel 152 containing a plurality of optical assemblies supported within instrument head 104 and more particularly within inner former 138. Barrel 152 is defined by opposed distal and proximal ends 154 and 156, respectively. The objective lens 160 is mounted within the distal end 154 of the barrel 152 adjacent to an optical window 161, the optical window 161 covering the distal end 154 of the barrel 152. A cylindrical hollow spacer 163 and a relay lens 166 are provided on the proximal side of the objective lens 160, and each of the spacer 163 and the relay lens 166 is disposed within the intermediate shaft portion 155 of the lens barrel 152. The barrel 152 further widens in diameter at its proximal end 156, holding an imaging lens 169 disposed relative to a field stop 170, with a coil spring 172 disposed between the field stop 170 and the imaging lens 169. A threaded retaining cap 175 at the proximal end 156 of the barrel 152 maintains pressure on the imaging lens 169. In addition, a field stop 164 is provided between the window 161 and the objective lens 160 in the barrel 152 to reduce light scattering, and an aperture plate 167 is provided in the barrel 152 near the relay lens 166.

As shown in fig. 2(b), 3 and 4, the proximal threaded portion 157 of the hollow barrel 152 engages a corresponding set of internal threads formed on the distal portion of the adapter interface member 180. The adapter interface member 180 is a substantially cylindrical portion according to the present invention having a distal end 182 that extends to the proximal end 116 of the instrument head 104, and further including an outwardly extending proximal end 188. The distal end 182 and the proximal end 188 of the adapter interface member 180 define a recess 184 therebetween, the recess 184 being sized and configured to receive a smart device adapter 300, partially shown in fig. 5. The recess 184 is substantially annular and comprises a series of machined flats 186 as shown in fig. 2(a) and 2(d) -2 (k). According to this embodiment, four (4) planes 186 are provided, but the specific number may be appropriately changed. In subsequent portions of the present application, further details regarding the smart device adapter 300 will be described in greater detail.

When assembled, the distal end 154 of the hollow barrel 152 is located at the distal end 112 of the instrument head 104, while the opposite proximal end 156 of the barrel 152 extends from an opening formed in the inner former 138. The adapter interface member 180 is threadably engaged with the proximal end 156 of the hollow barrel 152 and extends outwardly from an opening formed in the rear housing portion 134 of the instrument head 104.

A series of circumferentially spaced axial openings 183 are provided in the distal end 182 of the adapter interface member 180. Each axial opening 183 extending to the defined recess 184 receives a helical compression spring 185 and a ball 187, with a portion of the ball 187 extending into the recess 184 to provide secure engagement with the smart device adapter 300 when the ball 187 is attached. Intermediate plate 190 is positioned distally on the exterior of proximal end 156 of lens barrel 152 relative to the threaded portion of lens barrel 152 and is in contact with sealing member 142. According to this embodiment, adapter interface member 180 is further defined by an interior portion that includes an optical window 189 secured within an outwardly extending proximal portion 188. A forehead support or cap 194 covers the extended proximal end 188 of the adapter interface member 180.

The sealing member 142 is made of an elastomeric material and is disposed on the proximal end of the inner former 138 on a formed annular shoulder. When assembled, the sealing member 142 further engages over the intermediate plate 190 and the adapter interface member 180 to provide an adequate seal within the inner former 138 for insufflation of the patient.

With further reference to fig. 2(b) and 3, the distal end 154 of the hollow barrel 152 extends through the distal insert 140 such that an optical window 161 and an adjacent objective lens 160 are disposed at the distal end 154 of the distal insert 140. As previously discussed, the speculum tip element 120 is releasably attached to the distal end 112 of the instrument head 104. According to this embodiment, the speculum tip element 120 is a hollow member made of a lightweight molded plastic material, which is defined by a frustoconical shape having a distal tip opening 124 and an opposite proximal tip opening 128. The outer surface of the speculum tip element 120 comprises at its proximal end at least one engagement feature that allows the speculum tip element 120 to be releasably attached to the distal end 112 of the instrument head 104. According to this particular form, a total of three (3) engagement features are provided, each engagement feature comprising an inclined ramp having a series of closely spaced engagement teeth.

The speculum tip element 120 is arranged in an overlapping relationship on the distal insertion portion 140, which distal insertion portion 140 is defined by a substantially conical surface arranged in an overlapping relationship on the conical distal end 139 of the inner former 138. According to this exemplary embodiment, the inner former 138 may include at least one external feature shaped and configured for engaging and retaining the distal insert 140. The speculum tip element 120 is releasably fixed on a distal ring member 146, the distal ring member 146 being arranged within the distal end of the forward housing part 130, while the distal insertion part 140 extends distally beyond the distal ring member 146.

The distal annular member 146, which is arranged relative to the forward housing part 130, comprises a plurality of engagement features configured to allow releasable attachment of the speculum tip element 120. More specifically, the distal ring member 146 includes a plurality of ramped surfaces formed at circumferentially spaced locations, each ramped surface being shaped and configured to engage an external engagement feature of the speculum tip member 120. According to this embodiment, the distal ring member 146 is configured to receive one of a plurality of speculum tip elements 120, including those having instruments, each tip element 120 having external engagement features that engage with the inclined surface of the distal ring member 14.

The speculum tip element 120 is mounted on the distal insertion portion 140, and the external engagement features of the speculum tip element 120 are engaged by the angled surfaces provided on the distal annular member 146. The speculum tip element 120 is fixed and released by a suitable twisting movement. As noted, when attached, the speculum tip element 120 is designed to fit into the ear canal of the patient a predetermined distance.

The foregoing components combine to define the optical assembly of otoscope 100 described herein. As described in later sections of this application, a smart device adapter may be attached to the adapter interface member 180 to mount a smart device (e.g., a smartphone) to the instrument head 104 and enable capture of images of the ear canal, and more particularly, the tympanic membrane.

An alternative form of otoscope instrument head 104A is shown in fig. 5(a) and 5 (b). For clarity, similar parts are marked with the same reference numerals. The instrument head 104A according to this embodiment includes a front housing portion 130, a rear housing portion 134A and an inner former 138, as well as a distal insert member 140, a distal annular member 146 and a sealing member 142. However, this particular instrument form does not include a barrel or adapter interface member. Instead of these components, the instrument head 104A includes an eyepiece window 196, the eyepiece window 196 being provided at the proximal end 116 within a cover 198, the cover 198 being disposed within the rear housing portion 134A. The eyepiece window 196 may or may not be configured to provide optical power (magnification) to improve viewing of the medical target.

Referring to fig. 2(b), 3, and 5(b), the lower portion of each of the instrument heads 104, 104A described herein holds an illumination assembly. According to this form, the light source of the lighting assembly is an LED 244, which is disposed on the upper surface of the printed circuit board 240. The circuit board 240 is electrically coupled to a downwardly depending electrical contact 220, the electrical contact 220 being held in an insulating member 224 biased by a spring 254, the spring 254 being disposed with a condenser lens 250 within a lens holder 248 above the circuit board 240. The opposite ends of electrical contact 220 extend from openings formed in insulating member 224 and handle post base member 270. The fixing ring 280 is fixed above the lower end of the handle post base member 270. The handle post base member 270 includes an intermediate recess 273, the intermediate recess 273 being sized to retain the lower ends 131, 135 of the front and rear housing portions 130, 134A, 134 of the instrument head 104, the instrument head 104 being engaged by a securing ring 280. In accordance with at least one form, the retaining ring 280 can include a locking element, such as a pin (not shown) that can be inserted through a transverse opening 281 formed in the retaining ring 280.

According to this embodiment, the circuit board 240 is held on the upper shoulder of the handle post base member 270. The condenser lens 250 is integrally molded as a hemispherical portion into a lens holder 248 disposed over the LED 244 and the circuit board 240. According to this form, the lens holder 248 is made of moldable plastic. One end of the biasing spring 254 acts on a surface of the lens holder 248, allowing the LED 244 and the condenser lens 250 to be aligned and properly positioned relative to the lower portion 141 of the inner former 138, and more particularly relative to the sleeve 144, which sleeve 144 holds the polished end (not shown) of a set of optical fibers. The optical fiber travels upwardly within the inner former 138 and extends as a small loop (not shown) provided in the annular space between the distal insertion portion 140 and the conical distal end portion 139 of the inner former 138 to emit light toward the target of interest.

In operation, the received LED 244 is electrically engaged by the contact 220 biased by the retained spring 254. When the LED 244 is powered by the on/off switch 118 (shown in FIG. 1 (a)) disposed on the handle portion 108 (shown in FIG. 1 (a)), illumination from the LED 244 is directed through the condenser lens 250 and collimated light is directed to the polished proximal end of the optical fiber (not shown) at the lower end of the inner former 138. As noted, an optical fiber (not shown) is guided through the inner former 138, and the distal end of the optical fiber is disposed in a ring configuration at the distal end opening of the distal insertion portion 140 and around the periphery of the hollow barrel 152.

Intelligent device adapter

As shown in fig. 6-13(a), a smart device adapter 300 is depicted in accordance with an illustrative embodiment. The smart device adapter 300 is releasably attached to the proximal end 116 of a suitably configured body evaluation device, such as the otoscope 100 of fig. 1(a) described previously. Smart device adapter 300 according to this exemplary embodiment is defined by a housing or body 304 having a pair of housing portions, namely a front housing portion 308 and a rear housing portion 312, which combine when assembled to form an interior that is appropriately sized and shaped to hold a plurality of components. Each component of the smart device adapter 300 according to this embodiment is made of moldable plastic, but other suitable materials may be used.

Front housing section 308 of smart device adapter 300 is defined by a lower portion 320, lower portion 320 including a semicircular slot 322 provided at one end. In addition to the device engagement portion 328, the semi-circular slot 322 extends entirely through the thickness of the front housing portion 308, as best shown in fig. 8(a) and 11(e), 11(i) and 11 (j).

The device engagement portion 328 is defined by a pair of device engagement surfaces 330, 332, each engagement surface 330, 332 extending inwardly relative to the shaped slot 322 and adjacent the front surface 309 of the front housing portion 308. These engagement surfaces 330, 332 are orthogonal to each other and have a defined thickness.

The front face 309 of the front housing portion 308 also includes a recess 335, fig. 6, adjacent the semicircular slot 322 defined on the side of the slot 322 opposite one of the engagement surfaces 330. The recess 335 is sized and configured to receive the slide member 350, the slide member 350 being secured by a slide retainer 356. According to this embodiment, the slide member 350 is defined by an upper plate 352 having an edge surface 354 and a lower portion 353. The slide holder 356 is attached to the lower portion 353 of the slide member 350 using at least one fastener 358 and an engagement member between a downwardly extending tab of the lower portion 353 of the slide member 350 and a corresponding slot formed in an upper surface of the slide holder 356. When positioned within the recess 335, the edge surface 354 of the sliding member 350 is positioned on the same flat of the two device engagement surfaces 330, 332, forming a third device engagement surface. As shown in fig. 8(b), a compression spring 346 is provided within a lateral cavity formed in the lower portion 353 of the slide member 350 that engages a spring pin provided on the front housing portion 308 to bias the slide member 350 laterally, and more particularly, the edge surface 354 inwardly relative to the shaped slot 322. To facilitate movement, the underside of the upper plate 352 of the slide member 350 includes a set of guide rails 359 configured to slide within corresponding tracks 355 formed in the front housing section 308.

Referring to fig. 6, 7, 11(b), and 11(f), the rear housing portion 312 of the smart device adapter 300 includes respective inner and outer surfaces 313, 314. A slot 316 is formed in the lower end of the rear housing section 312. The slot 316 is further defined by an inner ridge 324. A peripheral boundary 326 formed on inner surface 313 extends around shaped slot 316 and the entire perimeter of rear housing portion 312. As discussed herein, the portion of the peripheral boundary 326 surrounding the slot 316 and the inner ridge 324 are sized and configured to support the pawl cover 370 and the device engaging member 360. Peripheral boundary 326 includes a semi-circular portion at the lower end of rear housing portion 312 that corresponds to semi-circular slot 322 formed in front housing portion 308 of adapter 300 described herein. A through hole 327 is also formed in the lower end of the rear housing portion 308 as part of the projection 340.

According to this embodiment, the pawl cover 370 is an elongated member having a front surface 371 and an opposing rear surface 372 that is sized and configured to fit within the shaped slot 316 of the rear housing portion 312. Molded tabs 373 are provided on the front surface 371 of the pawl cover 370 and are sized to receive the pawl members 384 as well as the pawl springs 394. The molded protrusion 373 is circular in configuration according to this exemplary embodiment and includes a pair of diametrically spaced slots 375, the slots 375 being sized to engage ears 389 formed on the detent member 384 to ensure a predetermined position within the protrusion 373. It will be appreciated that the molded protrusion 373 may take on other suitable configurations. The protrusion 373 is further defined by a through hole extending entirely through the thickness of the pawl cover 370 that enables access to the protruding pawl 391.

Adjacent to the molded protrusion 373 on the front surface 371 of the pawl cover 370 is a shaped recess 376, the recess 376 being sized and configured to receive a strip 395 of insulating material. According to this embodiment, the insulating material strip 395 is made of open cell foam such as polyurethane foam (poron), but other similar materials may be used.

The device engagement member 360 may be attached to the rear housing portion 312 of the smart device adapter 300 and, more specifically, to the molded slot 316. According to this embodiment, the device engagement member 360 is elongate and defined by opposing planar front and rear sides 361 and 362, respectively. The device engages the back side or surface 362 of the member 360 to receive an adhesive strip 363 mountable thereon. According to one form and referring to fig. 6, 7 and 12(a) -12(h), the rear side 362 of the device engagement member 360 is defined by a recess 366, the recess 366 being sized to receive and position the adhesive strip 363 into a predetermined position and orientation. According to another form, the adhesive tape may be removed and repositioned anywhere on the back side 362. The front side 361 of the device engagement member 360 includes a notch 367 formed transversely relative to the major dimension of the member 360 and adjacent one end.

Fig. 10(a) -10(e) provide an exemplary assembly flow. Referring first to fig. 10(a), a slide member 350 is attached to the front housing portion 308 and is mounted within the contoured recess 335, with a lower portion 353 of the slide member 350 extending through an access slot provided in the front face 309. The compression spring 346 is engaged within a lateral slot formed in the lower portion 353 of the slide member 350, wherein one end of the compression spring 346 is engaged with a spring pin (shown in fig. 10 (a)). As shown in fig. 10(b), the slide holder 356 is then attached to the slide member 350 through the access slot by engaging the tabs of the lower portion 353 with corresponding slots formed in the upper surface of the slide holder 356 and inserting fasteners 358 to secure the slide holder 356 and the slide member 350 within the recess 335 of the front housing portion 308.

As shown in fig. 10(c), a strip of insulating material 395 is added to the recess 376 formed in the rear housing part 312 and the detent member 384 and detent spring 394 are placed in the protruding housing 373 of the detent cover 370 with the ear portions 389 of the detent member 384 aligned with the corresponding spaced apart slots 375 formed on the protruding housing 373. Once the aforementioned components are in place, detent cover 370 is placed on the inside of rear housing part 312 and, more specifically, slot 316 of detent cover 370 having a boundary edge is placed on peripheral boundary 326.

As shown in fig. 10(d), the front housing portion 308 with the assembled slide members 350 and slide retainers 356 is then aligned and attached to the rear housing portion 312, the rear housing portion 312 having the assembled pawl cover 370, pawl members 384 and pawl springs 394 and strip 395 of insulating material.

Finally, as shown in fig. 10(e), rear housing portion 312 and front housing portion 308 are secured using a series of threaded fasteners 317 through a series of mounting holes 315 provided in each of rear housing portion 312 and front housing portion 308 of smart device adapter 300. When assembled, the detent cover 370 is clamped inside the smart device adapter 300 along with the detent member 384, detent spring 394, insulating material strip 395, and attached slide member 350 as shown.

The device engagement member 360 may then be slidably attached to the slot 316. Referring to fig. 9(a), 9(b)11(a), 11(b), and 11(k), the detent member 384 is retained within the interior detent cover 370 of the adapter 300. The pawl member 384 according to this embodiment includes a protruding pawl 391 that is sized and shaped to engage a transverse notch 367 formed on the front surface 361 of the device engaging member 360 when the device engaging member 360 is attached by sliding the device engaging member 360 within the open end of the profiled slot 316.

As shown in fig. 9(a), 9(b) and 11(a), when the device engagement member 360 is engaged within the slot 316 of the rear housing portion 312, the bias of the detent spring 394 enables the detent member 384 to move slightly forward relative to the transverse groove 367 formed in the device engagement member 360 to provide a greater retaining force when the device engagement member 360 is attached to the adapter 300. The band or pad of insulating material 395 eliminates rattle and provides a defined resistance when the user slides the device engaging member 360 into the defined slot 316. The device engagement member 360 slides an appropriate distance within the slot 316 until the front surface of the device engagement member 360 engages the spring-loaded pawl member 384. Preferably, a slight mismatch is created between the protruding detent 391 and the transverse groove 367 formed in the device engagement member 360 to bias the device engagement member 360 forward. 11(a) -11(1) depict additional views of the forward interface portion and the rear interface portion of the smart device adapter 300, illustrating each of the features previously described.

In operation, the device engagement member 360 may first be attached to the front surface of the smart device using a fixture (not shown). Preferably, when the smart device is attached, the device engagement member 360 is positioned on the smart device (e.g., smartphone) in a position that enables alignment of the optical axis of the smart device with the optical axis of the physical assessment device. When the smart engagement member 360 is attached to the smart device, the through hole 327 of the rear housing portion 312 is aligned with the optical axis of the smart device. When attached, the protrusions 340 formed on the rear housing portion 312 of the adapter 300 minimize intrusion of ambient (room) light into the system.

Referring to fig. 13(a), the smart device adapter 300 may be attached to the proximal end 116 of the physical assessment device 100 by aligning the device engagement portion 328 of the adapter 300 with the recess 184 of the adapter interface member 180. The three engagement surfaces 330, 332, and 354 have a thickness that can fit within the recess 184 of the adapter interface member 180. Further, the configuration of the three (3) device engagement surfaces 330, 332, and 354 of the smart device adapter 300 (including their lengths and relative spacing) enables the smart device adapter 300 to be releasably attached relative to the adapter interface member 180 (and more particularly, relative to the machined plane 186). Slot 322 of front housing portion 308 of adapter 300 is wide enough to accommodate proximal end portion 188 of adapter interface member 180 (including brow rest 194).

As noted, since the spring-loaded slide member biases the engagement surface 354, continuous circumferential contact of the engagement surfaces 330, 332, and 354 with the machined flat 186 is provided. Furthermore, the axial opening of the adapter engagement member, more specifically the spring loaded ball 187 of the adapter interface member 180, abuts the intermediate plate 190, further biasing the attached smart device adapter 300 in the direction of the optical axis of the physical evaluation device 100 and providing a stable mounting platform for examination.

For positioning purposes, the smart device adapter 300 (and attached smart device (not shown)) may be placed in one of four (4) different positions, each at 90 degrees around the optical axis of the body evaluation device 100. According to this embodiment, the smart device adapter 300 is removed from the body assessment device 100 and rotated prior to reengaging the slot of the adapter 300 with the machined flat 186 of the adapter interface member 180. This adjustment may be made with the smartphone attached to the smart device adapter 300 or without the smartphone attached to the smart device adapter 300. For example, it should be understood that the number of machined flats may be appropriately varied to provide a suitable number of mounting locations.

According to another embodiment, the adapter described herein may be mounted to a body evaluation device, such as an otoscope or ophthalmoscope, without the need for prior optical alignment using a calibration device. Rather than adhesively attaching or otherwise attaching the device engagement member 360 to the smart device after calibration, the device engagement member 360 is initially attached to the smart device adapter 300 by sliding the device engagement member 360 into a slot 316 provided on the rear housing portion of the adapter 300 until there is a sound or other indication that the device engagement member 360 has been placed into a predetermined position. In at least one form, an audible click or other indication such as an actuator is provided to the user. The adhesive layer 363 of the device engagement member 360 is then removed to enable the device engagement member 360 to be attached to the surface front of the smart device, wherein the visual alignment of the user aligns the through hole 327 in the adapter 300 with the optical axis of the attached smart device. The two components are then assembled by pressing the adhesive layer 363 of the device engagement member 360 against the front side of the smart device. To remove the smart device from the adapter 300, the smart device may be pulled out of the device engagement member 360. This technique allows a variety of numbers of different sized smart devices to be releasably mounted to the common smart device adapter 300.

As shown by the ray trace depicted in fig. 13(b), for a body evaluation device 100 comprising an instrument head 104 and an attached smart device adapter 300, the optical assembly of otoscope 100 described herein produces a virtual distal entrance pupil 125 within the attached speculum tip element 120 (as shown in fig. 2 (a)). According to this embodiment, the entrance pupil is formed with a position distal to the optical window and the objective lens. The entrance pupil is positioned such that the attached speculum tip element 120 is not "seen", that is, the light rays reflected from the medical target effectively pass within the tip opening of the speculum tip element 120 of fig. 2(a), while still allowing a large field of view, allowing the entire tympanic membrane to be seen all at once. As shown, light reflected from the medical target is directed along a defined optical axis towards an optical element, not shown, of the attached smart device. The beneficial effects of the entrance pupil are further illustrated in fig. 54(a) and 55.

Referring to fig. 14-16, a variation of the smart device adapter 400 is described for use with another physical evaluation device 450. For clarity, similar parts are marked with the same reference numerals. According to this embodiment, body assessment device 450 is a Pan optical commercially sold by Welch Arlin, Inc., Skanateles Falls, N.Y.<^TM>An ophthalmoscope. The ophthalmoscope 450 is defined by an instrument head 454 which is releasably attached to a handle portion (not shown). The instrument head 454 includes a distal (patient) end 456 and an opposite (caregiver) end 459. An optical system (not shown) within instrument head 454 is configured to enable examination of the patient's eye together with a housed illumination system (not shown) that includes at least one light source to illuminate the examined eye.

According to this embodiment, the smart device adapter 400 is similar in construction and function to the form previously described in fig. 6-13(a) in that the smart device adapter 400 includes a pair of housing portions 308, 312 that retain a detent cover 370 and a detent member 384, the detent member 384 being biased by a received detent spring 394. Rear housing portion 312 includes a slot 316, slot 316 configured to receive a detent cover 370 and a device engagement member 360, device engagement member 360 slidably engaged with slot 316 formed on adapter 400, and includes a transverse groove 367 that engages a detent member 384. Housing portions 308, 312 are secured to one another using a set of fasteners 317. The adapter 400 further comprises a through hole 327, as shown in fig. 16, the through hole 327 being aligned with the optical axis of the body evaluation device 450 when the adapter 400 (and the smart device 480) are attached.

The smart device adapter 400 according to this embodiment further comprises a flexible arm 420, the distal end 424 of the flexible arm 420 comprising an annular portion 428. The annular portion 428 is sized to be disposed on the downwardly extending portion 458 of the instrument head 454. The proximal end 429 of the flexible arm 420 is releasably attached to the front housing section 308 of the smart device adapter 400. In accordance with this form, the front housing portion 308 includes an opening 433, the opening 433 being sized to receive the proximal end 429 of the flexible arm 420.

Referring to fig. 17-20, a smart device adapter made in accordance with another exemplary embodiment is described herein. First, referring to fig. 17, a known body evaluation device and the otoscope 100 of fig. 1(a) are shown in a side-by-side relationship. As previously discussed, otoscope 100 includes an adapter interface member 180 at its proximal end 116 such that smart device adapter 300 of fig. 6 is releasably attached. A known evaluation device 500 is Macroview, commercially sold by Welch Allyn, Inc., of Skanateles Falls, N.Y.<^TM>Otoscopes, may also be configured with adapters to enable smart devices to be attached. The known apparatus is defined by an instrument head 554, the instrument head 554 including a distal (patient) end 556 and an opposite (caregiver) end 559, wherein the instrument head 554 is attached to an upper end of a handle portion 558. A speculum tip element 560 is attached to the distal end 556 of the instrument head 554. An optical assembly and an illumination assembly (not shown) are housed within instrument 550, instrument 550 including an eyepiece 563 provided at a proximal end 558 and a focusing wheel 562 provided on a medial outer portion of instrument head 554, focusing wheel 562 enabling relative movement of at least one housed optical element (not shown).

Referring to fig. 18-20, a smart device adapter 500 according to this embodiment includes a support plate or substrate 504 having an upper portion 508 and an opposing lower portion 512. The support plate 508 may be made of a durable molded plastic, although other structural materials may be suitably used. The upper portion 508 includes a through hole 516, and a hollow cylindrical protrusion 520 aligned with 516. A hollow protrusion 520 extends distally from upper portion 508 and is defined by a cavity sized and configured to fit over proximal end 558, and more specifically over eyepiece 563 of known physical assessment device 550. A flexible joint 522 formed at the lower portion 512 of the substrate 504 is defined by a C-shaped joint end 524. The engagement end 524 is sized and configured to releasably engage a cylindrical handle portion 558 of a known body assessment device 500. Although the known body evaluation device 550 is an otoscope, it will be apparent to those skilled in the art that other handheld medical diagnostic devices may be similarly configured for attachment.

With further reference to fig. 18-20, for attachment, the protruding cylindrical portion 520 is first mounted onto the proximal end 558 of the body assessment device 550. Such an installation still enables the caregiver to access the focusing mechanism 562 of the physical evaluation device 550. The smart device adapter 500 is then rotated until the C-shaped engagement feature 524 is aligned with the handle portion 558, allowing the C-shaped engagement feature 524 to clip onto the handle 558. The C-shaped joint 556 is angled relative to the base plate 504 to illustrate the angled configuration of the instrument head 554 of the otoscope 550.

A smart device such as a smart phone (not shown) may be attached to the proximal end of the support plate 504 in a manner similar to those previously described. Advantageously, the adapter 500 described herein can be attached to a body assessment device in seconds, thereby converting the body assessment device from an optical to a digital body assessment device without requiring any modification to the device. Once attached, the smart device allows the user to take pictures and videos using the physical assessment device 550 and then seamlessly transfer the images or videos to digital medical records or other digital storage media used in the office or hospital.

Modified otoscope

Fig. 21 and 23 illustrate an otoscope 1100 made in accordance with another exemplary embodiment. According to this embodiment, instrument head 1104 of otoscope 1100 is defined by a distal end 1112, an opposite proximal end 1116, and a downwardly extending portion 1120 attached to handle 1108, the downwardly extending portion 1120 being shown only in fig. 21. A disposable hollow speculum element 1124 is releasably attached to the distal end 1112 of the instrument head 1104, and more specifically to the tip holding element 1170, while an optical window 1128 is provided on the proximal end 1116. In use, speculum tip 1124 is shaped and configured to be inserted a predetermined distance into a patient's ear, and optical window 1128 enables viewing of a medical object of interest (e.g., the tympanic membrane) through open distal opening 1125 of speculum tip 1124.

Referring to fig. 22 and 24(a), an alternative instrument head 1204 of an otoscope 1200 is similarly defined by a distal end 1212, an opposite proximal end 1216, and a downwardly extending portion 1220. A disposable speculum tip element 1124 is releasably attached to the distal end 1212 of the instrument head 1204 and, more specifically, to the tip holding member 1170. As shown in fig. 24(b), a rear mounting member 1224 extending from the proximal end 1216 (also collectively referred to as an adapter interface member) is configured to receive a smart device 1230, such as a smartphone, using an interface member 1240 (the interface member 1240 aligning the optical axis of the instrument 1200 with an electronic imager of the smart device 1230) to digitally image an object of interest (e.g., the eardrum) through a display of the attached smart device 1230.

Fig. 25(a) -25(d) show the components of instrument head 1104. The instrument head 1104 according to this embodiment includes a pair of housing portions 1134, 1138 (one housing portion 1134 being shown in the exploded view of fig. 25 (a)) that mate with one another around an inner former 1140 that forms the internal cavity of the instrument head 1104. The interface studs 1150 extend downwardly from the inner former 1140 into a downwardly extending portion 1120 of the instrument head 1104 to enable connection to the instrument handle 1108 of fig. 21. A conically shaped distal insertion portion 1160 is provided on the distal end 1112 of the instrument head 1104, and a speculum tip 1124 is placed in overlapping relation on the distal end 1112 of the instrument head 1104 and releasably secured to the tip holding member 1170. A proximal housing member 1180 is secured to the rear end of the inner former 1140. The proximal housing member 1180 includes a mounting flange 1184 having a pair of spaced apart slots 1186 that allow for lateral attachment of the optical window 1128. Between the mounted proximal housing member 1180 and the rear of the inner former 1140 is a recess 1187 which allows for the inclusion of a sealing member (not shown). A retaining ring 1190, threaded to the interface stud 1150, secures the housing portions 1134, 1138 together, and a cover 1142, attached to the top of the instrument head 1104, covers the mating edges of the housing portions 1134, 1138.

Referring to fig. 26(a) -26(b), the assembly of the instrument head 1204 similarly incorporates housing portions 1134, 1138 that fit around an inner former 1150, the inner former 1138 forming an interior compartment of the instrument head 1204. Similarly, the assembly includes a cap 1142, a distal insertion portion 1160, a tip retaining member 1170, and an interface stud 1150, a threadingly retained retaining ring 1190, the retaining ring 1190 extending down to a narrow neck 1220. Instead of a proximal housing member holding an optical window, a rear mount (adapter interface) member 1224 is provided at the proximal end 1218 of the instrument head 1204. According to this embodiment, and similar to the previously discussed design (see 180 of fig. 1 (a)), the rear mounting member 1224 has a defined mounting flange 1226 and an annular slot 1228, the annular slot 1228 being configured to receive an interface member (smart device adapter) 1240 and an attached smart device 1230, as previously shown in the assembled form in fig. 24 (b).

Fig. 27 and 28 show cross-sectional views of assembled instrument heads 1104, 1204, respectively. Referring to fig. 27, instrument head 1104 of eyepiece 1100 of fig. 21 enables an image of a medical target (e.g., the tympanic membrane) to be seen through a proximal end 1116 of instrument head 1104, looking through an optical window 1128 supported by proximal housing member 1180. This enables viewing of a medical object (e.g., the tympanic membrane) through the interior compartment created by the inner former 1140 and the distal openings 1127, 1161 formed in the distal insertion portion 1160 and the speculum tip 1124, respectively.

Referring to fig. 28, the optical assembly is disposed inside the instrument head 1204 of the otoscope 1200 according to this exemplary embodiment. Portions of the optical assembly are held within a tubular member (also collectively referred to as a barrel) disposed in an interior compartment created by an inner former 1140, the inner former 1140 comprising a plurality of optical elements each aligned and disposed along a defined optical or visual axis of the device 1200, the device 1200 extending between the distal end 1212 and the proximal end 1216 of the instrument head 1204. The details of the optical assembly are described in more detail later in this specification. As referred to herein, "optical element" refers to lenses and prisms as well as field stops, aperture stops, polarizers, and any components for directing or transmitting light along a defined optical or visual axis. As in the form of the body evaluation device 100 previously described in fig. 1(a) and 13(b), the optical assembly according to this exemplary embodiment produces an entrance pupil distal end with respect to the most distal optical element of the optical assembly, thereby creating a field of view that allows the entire tympanic membrane (about 7mm for an average adult) to be seen at once.

Further, a seal member 1250 is disposed rearward of the inner former 1140 and engages the formed annular groove 1187. The sealing member 1250 provides sufficient sealing for the formed interior compartment of the instrument head 1204 to allow insufflation capability (insufflation port not shown in this view) and also prevents fogging of the retained optical element.

Each otoscope instrument head 1104, 1204 depicted in fig. 27 and 28 generally includes an illumination assembly disposed within the downwardly extending portion 1120, 1220, and more particularly, within the interface stud 1150. Fig. 33 more clearly shows the illumination assembly according to this embodiment, which includes the LED1270 as a light source. More specifically, the LED1270 is disposed on an upper surface 1272 of a printed circuit board 1274, the printed circuit board 1274 being electrically coupled to downwardly depending electrical contacts 1278 biased by springs 279 disposed within the inner sleeve 1280, the distal ends of the electrical contacts 1278 extending from an opening in the narrow portion of the inner sleeve 1280 and proximate to an opening 1285 formed in the bottom of the instrument head 1104, 1204. The LED1270 is positioned relative to the condenser lens 1290 and the polished proximal end of the fiber bundle 1287, and the fiber bundle 1287 travels up around the inner former 1140 and extends as a small ring of fibers (not shown) between the distal end of the distal insert 1160 and the inner former 1140 to emit light toward the target of interest.

In each of the devices 1100, 1200 described above, and as described above, a pair of housing portions 1134, 1138 may be secured to one another at respective mating edges by ultrasonic welding, and a cover 1142 introduced over the top of the instrument heads 1104, 1204.

Referring to fig. 29 and 30, and according to another exemplary embodiment, the instrument head 1304 of fig. 29 and the instrument head 1310 of fig. 30 are shown. Each of these instrument heads 1304, 1310 is similar to instrument heads 1104, 1204. The instrument heads 1304 and 1310 include a pair of mating housing shell portions 1324, 1328 that are attached to each other using an intermediate member, referred to herein as a strap 1340. For clarity, similar structural components are labeled herein with the same reference numerals. The strap 1340 according to this particular embodiment is a single member made of a flexible, structural type material and has an upper portion 1344 and a lower portion 1348.

As shown more particularly in fig. 31, the upper portion 1344 of the strap 1340 is defined by a rounded inner surface 1346 that is shaped and sized to encircle the respective first and second housing shell portions 1324, 1328 after the mating edges of the housing portions 1324, 1328 are placed in intimate contact with each other. According to this embodiment, the housing shell portions 1324, 1328 define respective halves of the instrument heads 1304, 1310. Each housing portion 1324, 1328 includes a recess 1330 formed in an outer surface in which the strap 1340 is received so that the outer surface of the strap 1340 is substantially co-extensive with the exterior of the mating housing portion 1324, 1328 when attached.

During assembly/manufacturing, the inner edges of the pair of housing portions 1324, 1328 are placed in close contact and the strap 1340 snaps through the recess 1330 onto the instrument head 1304. Referring to fig. 31 and 32, each lower extending portion 1348 of the intermediate webbing 1340 includes an annular flange 1352 formed on an inner surface thereof, and an annular shoulder 1356 formed at an end of each lower extending portion 1348. As shown in fig. 32, the annular flange 1352 of each lower extending portion 1348 is retained within an annular groove 1153 formed in the interface stud 1150 and secured by the threaded engagement of the retaining ring 1190 with the bottom of the interface stud 1150 of the instrument head 1304, with the upper end of the retaining ring 1190 engaging the shoulder 1356.

Referring to fig. 33-36, the illumination assembly is retained within a downwardly extending portion 1120 of the instrument head 1104. According to the described embodiment, the lighting assembly includes an LED1270 attached to the top or top surface 1272 of the printed circuit board 1274 in a known manner. Disposed over the LED1270 and printed circuit board 1274 is an integrated component 1420, which integrated component 1420 serves to center and align the LED1270 and also to collimate the light emitted from the LED 1270. An outer edge 1275 of printed circuit board 1274 is secured to an interior shoulder 1156 of interface stud 1150. As shown in the cutaway view of fig. 34, the integrated component 1420 is defined by a cylindrical body 1422, the cylindrical body 1422 having an upper end 1426, a lower end 1430, and a set of external threads 1434 extending along the length of the integrated component 1420. An internal flange 1438 is provided at an intermediate distance between the upper end 1426 and the lower end 1430 of the integrated component 1420, the flange 1438 having a corresponding and opposing top surface 1442 and bottom surface 1446.

A dome portion 1450 disposed at the center of the top surface 1442 of the inner flange 1438 is axially aligned with the LED1270 and acts as a condenser lens. The annular ring 1458 extending downwardly from the bottom surface 1446 of the inner flange 1438 is configured and dimensioned to surround the lens housing of the LED1270 and serves to center the dome portion 1450 with the LED1270, thereby minimizing eccentricity between the LED1270 and the dome portion 1450, as well as any associated light transmission losses. The set of external threads 1434 are configured to mate with corresponding internal threads 1460 provided in the interface stud 1150 of the instrument head 1104. This mating allows integrated component 1420 to itself secure printed circuit board 1274 within interface stud 1150, and further ensures secure electrical contact between printed circuit board 1274 and interface stud 1150. This fixation further prevents the ingress of dust and debris.

In accordance with this particular embodiment, as shown in FIG. 35, a series of notches 1468 are provided in spaced relation along the upper end 1426 of the integrated component 1420. The recess 1468 is shaped and configured to receive a protrusion provided in a complementary driving or torquing tool (not shown) for assembly. The printed circuit board 1274 according to this embodiment also includes an outer ground ring in intimate electrical contact with the metal studs. The threaded connection between the integrated component 1420 and the interface stud 1150 of the instrument head ensures a secure high pressure fit at this junction. As noted, the dome portion 1450 collimates the illumination from the LEDs 1270. Advantageously, the design of the integrated component 1420 serves to save manufacturing costs and labor, and also reduces tolerance stack-up, as well as preventing or minimizing the ingress of dust and contaminants.

The cutaway of fig. 37 illustrates an embodiment of the interconnection between the instrument head 1104 and the instrument handle 1108 of fig. 21 for the physical assessment device 1100. As shown, instrument handle 1108 is a substantially cylindrical member having an upper or top end and an opposite lower end, and at least one internal compartment sized and configured to hold at least one battery to power a light source housed within instrument head 1104. It should be noted that similar connections are provided to the instrument head previously described in this application.

Each instrument head 1104, 1204 (such as those shown in fig. 27 and 28, with an LED1270 as the housed light source) may be interchangeably attached to the instrument handle 1108 by a bayonet connection between the tip of the instrument handle 1108 and the narrow neck of the instrument head 1104. Such as those known as physical assessment devices commercially sold by Welch Allyn, provides a bayonet connection between the instrument head and the instrument handle. More specifically, a set of spaced lugs are provided on the top of the instrument handle which engage corresponding slots formed in the lower end of the instrument head when the instrument head is twisted in a predetermined direction.

As noted, each of the previously described instrument heads (including instrument heads 1104, 1204 or instrument head 104 of fig. 13(b), instrument head 104A of fig. 5 (a)) includes an LED as the light source of the housed illumination assembly.

There is a need to develop LEDs as light sources in body assessment devices to prevent the use of, among other things, some instrument handles that are connected to a wall-mounted system that does not power the instrument head equipped with halogen lamps. Halogen lamps absorb large currents and associated voltage drops through the wall power line. This voltage drop makes it difficult to comply with safety standards and forces the inclusion of further expensive electronics. On the other hand, LED systems consume relatively little current and do not have this disadvantage. With the development of instrument heads and the use of LEDs as illumination sources, it is anticipated that these instrument heads may be used with existing instrument handles. However, with the development of wall mounted systems, it is desirable to prevent the use of existing instrument heads having halogen light sources.

Referring to fig. 37-43, embodiments are described herein for making instrument handles incompatible with certain instrument heads (i.e., those having halogen lights). Referring to fig. 38, the instrument handle 1602 includes a top 1604. A pair of equidistant lugs 1612 are provided on the exterior of the top 1604 of the instrument handle 1602. Each lug 1612 according to this embodiment is defined by a width dimension represented by arrow 1616, such that the lug 1612 can fit within a defined bayonet slot of a mating instrument head.

Fig. 39 and 40 show the instrument head 1620. In this case, the body assessment device is an ophthalmoscope, but the principles are generic to other body assessment devices (e.g. the otoscopes described previously). A mating connection is provided at the bottom of the instrument head 1620 and includes an interface stud 1624 having a bottom end 1628 defining a shaped slot 1632 to provide a secure locking engagement by way of a snap-fit connection when the instrument head 1620 is rotated relative to the instrument handle 1602.

As the assembled interface is more clearly shown in fig. 41 and 42, each of the spaced lugs 1612 of the instrument handle 1602 is engaged within a shaped mating slot 1632 of the instrument head 1620. In this installed position, the electrical contacts 1640, 1646 of the device head 1620 and the device handle 1602 are positioned in contact with each other. For purposes of this embodiment and referring to fig. 42, the shaped mating slot 1632 is increased in width dimension to allow interchangeability between various instrument heads and handles. Referring to fig. 43, the width dimension of the mating lug 1612 of the instrument handle 1602 can be increased such that the lug 1612 will not fit within a mating slot (not shown) of an existing ophthalmic instrument head having a halogen light source.

Referring to fig. 44, an exemplary instrument handle 1706 is shown having an upper end 1707 including a top 1709 and an opposite bottom end 1711. FIG. 45 further illustrates a partial cross-sectional view of the upper end 1707 of the instrument handle 1706. More specifically, the upper end 1707 includes a rheostat assembly 1712 that selectively adjusts the illumination level of a retained light source (such as the at least one LED1270 of fig. 33) when attaching an instrument head (not shown) to the instrument handle 1706. The connection is made using bayonet engagement features provided on each mating part, such as those previously discussed. When connected, the LED1270 of fig. 33 is powered by coupling between the retained battery 1714 (partially shown in fig. 45), the varistor assembly 1712, the electrical contact 1717 biased by the spring 1721, and the electrical contact 1640 of fig. 40 to electrically couple the LED1270 of fig. 33 with the battery 1714.

Referring to fig. 45-48, and in accordance with one embodiment, the varistor assembly 1704 includes a twistable grip portion 1718 provided on the exterior of the instrument handle 1706. A twistable grip portion 1718 is provided on a cylindrical pawl ring member 1722 having a series of holes 1726 disposed along its periphery near a lower end 729 of the pawl ring member 1722, as shown more clearly in fig. 47. The pin member 1732 extends within an annular recess 1734 formed in the ratchet ring member 1722 and is biased to be retained within a recess 1736 formed in the inner sleeve 1750. Ball 1740 is also biasedly retained in an opening formed in inner sleeve 1750, which is diametrically opposed to the opening of pin member 1732. Ball 1740 is configured to rotate with twistable grip portion 1718 and extend ball 1740 into a hole 1726 in ratchet ring member 1732, ratchet ring member 1732 being fixed to create an audible and tactile sensation for the user. Each of the ball 1740 and the pin member 1732 is biased by a spring 1744, 1748, the springs 1744, 1748 being disposed within diametrically opposed openings in the inner sleeve 1750 that extend in a direction transverse to the main axis of the instrument handle 1706. The detent ring member 1732 includes a set of internal threads 1725 that engage a corresponding set of external threads 1757 provided on a varistor housing 1758.

In operation, the twist-grip 1718 rotates about the fixed ratchet ring member 1722. The pin member 1732 is keyed to the twist grip 1718 and rotates with the grip 1718 when twisted by the user. Spring-loaded ball 1740 also rotates with rotatable grip 1718 and snaps into one of a series of holes 1726 provided in fixed ratchet ring member 1722, depending on the rotational position of grip 1718. The properties of spring 1748 of biasing ball 1740 may be suitably varied as needed to provide the desired brake release force. The foregoing provides both audible and tactile feedback regarding the position of the varistor. This feature allows the user of the instrument to create a preferred setting that can be repeated to achieve a consistent amount of light with each use. The detent position and size and configuration of the detent stop may be varied in order to provide different sound or release intensities at different or selected positions (e.g., the zero position or other rheostat positions).

Referring to fig. 48 and 49, the instrument handle 1706 may be equipped with a USB charging or power boost port 1760. According to this embodiment, a USB port 1760 is provided on the exterior of the instrument handle 1706 near the bottom or lower end 1711. However, it should be understood that the location of the port 1760 may be suitably varied with respect to the instrument handle 1706. Referring to the cross-sectional view of fig. 49, and in accordance with this embodiment, the charging port 1760 extends to a USB connector 1768, the USB connector 1768 is mounted to a top surface of a printed circuit board 1772, the printed circuit board 1772 being disposed inside the instrument handle 1706 with contacts extending to a housed battery 1714 (partially shown in this view). According to this embodiment, a set of charging contacts extend axially from the lower end 1709 of the instrument handle 1706, enabling the instrument to be used in conjunction with the charging base or cradle 1800 of fig. 52, which enables at least one housed battery 1714 to be charged.

According to this embodiment and referring to fig. 49 and 50, a positive contact 1777 extending from the lower end 1709 of the instrument handle 1706 is soldered to a printed circuit board 1772 via a connector 1779, and a conductive spring clip 1782 is provided to act as a negative contact connecting an outer ring 1713 at the bottom end 1711 of the instrument handle 1706 with the printed circuit board 1772, the outer ring 1713 being electrically coupled to the lower contact end of a battery 1714. As such, the instrument handle 1706 described herein may be configured in a dual charging mode.

The norm in the medical industry is to charge the instrument handle (power source) through a desktop charger or more modern use USB. Referring to fig. 50, a circuit is depicted that allows one or more instrument handles to be charged via a desktop charger (e.g., base 1800 or USB charging port 1760). The charging circuit uses a charging IC and receives power through a USB input or through positive and negative contact pins.

Fig. 51 illustrates a cross-sectional view of an alternative charging mode, in which electrical contacts 1777 and 1782 are coupled to corresponding charging pins 1809 provided in charging wells 1814 of charging base 1800, only partially shown in this figure.

Fig. 52 provides a perspective view of a charging base 1800 made in accordance with an embodiment and including a pair of charging wells 1814 extending from a top surface 1811. Each charge well 1814 is sized to receive an instrument handle 1822, 1832 of a physical assessment device 1820, 1830 and provide a stable base, the charge wells 1814 having a defined height that creates a stable base for the held physical assessment device 1820, 1830. With continued reference to fig. 52, a pair of physical evaluation devices 1820, 1830 (more particularly, an ophthalmoscope and an otoscope) are typically held in separate charge wells 1814 of the charging base 1800, wherein each held device 1820, 1830 includes an attached smart device 1828, 1838, such as a smartphone. As shown, two physical evaluation devices 1820, 1830 are installed simultaneously and respective instrument handles 1824, 1834 are inserted into the charge well 1814 so that the remaining smart devices 1828, 1838 oppose each other. In this installed position, there is no interference between the installed devices or between the retained body assessment devices 1820, 1830 and the charging base 1800.

In accordance with one form and as shown in fig. 53, a thermistor, thermocouple 1790 or other temperature determining device can extend from a printed circuit board 1772 within the instrument handle 1706 through a connector 1792 and be disposed relative to a housed battery 1714. The output of the thermistor 1790 provides a direct battery temperature measurement during charging and discharging of the battery 1714, which battery 1714 may also be coupled to an indicator (not shown) on the charging base 1800 or instrument handle 1706 of fig. 52. In this way, potential overheating of a housed battery (such as an alkaline battery) can be monitored.

Due to the fact that the halogen-based and LED-based instrument heads can be used interchangeably, the instrument handle is designed to prevent overheating of the contained alkaline battery, especially if a halogen-based instrument head is installed.

An example of a circuit aimed at solving this problem, shown in fig. 53, prevents the housed battery from overheating. The circuit employs a boost design with input current limiting (e.g., Texas Instruments TPS 61251). With this circuit design, a current limit can be placed on the boost IC so that if the halogen lamp is connected to the instrument handle with an alkaline battery, the current will be limited and not exceed the limit of the battery which would cause overheating.

In addition, the boost IC will improve the performance of instrument heads equipped with LEDs as light sources and instrument heads that subsequently replace lamps with LEDs.

As discussed, the interior of at least one of the instrument head 104 of fig. 2(b), 13(b), and 1204 of fig. 28 described herein may hold an optical system or optical assembly comprising multiple components aligned along an optical axis or visual axis extending through the distal opening 124, 1125 of the hollow speculum tip element 120, 1124 releasably attached to the instrument head 104, 1204 and continuing through the interior of the instrument head 104, 1204, through the proximal end of the instrument head 1014, 1216.

Referring now to fig. 54(a), depicting the ray trajectories of the optical system or assembly 1900 of the body evaluation device 100 of fig. 2(b) and 13(b) and 54(b), a comparison is provided between three (3) additional optical assemblies 1910, 1940 and 1950 for the exemplary instrument head, including the optical assembly of instrument head 1204. The bottom-most optical component 1910 described is representative of known optical components, which are fully described in U.S. patent No. 7,399,275, and is incorporated by reference herein in its entirety.

First and referring to fig. 54(b), a known optical assembly 1910 includes a distal objective doublet 1914 to be disposed near a distal opening of a distal insertion portion 1160 (shown in fig. 28) of an instrument head 1204, the instrument head 1204 having a speculum tip element 1124 attached. A pair of aligned relay lenses 1919, 1922 is disposed at the proximal end of the objective doublet 1914, and an aperture plate 1920 is disposed between the pair of relay lenses 1919, 1922. A set of eyepiece lenses 1930 are disposed proximate to second relay lens 1922, each eyepiece lens aligned along a defined optical axis. The optical assembly 1910 produces an entrance pupil (shown as 1934) that is close to but distal with respect to objective doublet 1914 and, when optically viewed, produces a field of view that enables the entire tympanic membrane to be seen at once at the image plane of the clinician's eye or at the image plane of an attached digital imager (not shown). More specifically, the optical assembly 1910 produces a field of view of about 9mm at a working distance of about 33mm (the distance between the most distal optic and the patient), which allows the entire tympanic membrane (about 7mm) to be seen at one time. Although this optical assembly 1910 is very effective due to the increased field of view, the resulting image is affected by the attached speculum tip 1124, as shown at the top of fig. 55.

Referring to fig. 54(b), two further optical assemblies 1940 and 1950 are shown and in comparison to optical assembly 1910 of fig. 54(a), fig. 54(a) shows optical assembly 1900 of instrument head 100 of fig. 2(b), 13 (b). More specifically, optical assembly 1940 includes and is arranged, in order from distal-most to proximal-most: an objective lens 1941, a relay lens 1942, a field stop 1945, an imaging lens 1943, and a flat window 1944. Similarly, optical assembly 1950 is defined distally to proximally by objective lens 1967, relay lens 1968, field stop 1971, imaging lens doublet 1969, and plano window 1970. The optical assembly 1900 of fig. 54(a) is similar to optical assembly 1950 and is defined by the following elements from the most distal to the most proximal: an optical window 161 disposed distally relative to the objective lens 160 separated by the field stop 164 of fig. 4 (the field stop 164 reducing light scatter), a relay lens 166, an aperture plate 167 of fig. 4, the field stop 170 of fig. 4, an imaging lens 169, and a window 189 provided at the proximal end of the assembly 1900.

The optical components of each of these optical assemblies 1900, 1940, 1950 are also configured to produce an entrance pupil distal to the most distal optical element 160/161, 1941, 1967, respectively.

The overall effect is shown in the schematic comparison diagram depicted in fig. 55, comparing a known optical system 1910 with optical assemblies 1900 and 1950, where each optical assembly is disposed within an instrument head 1204 for comparison purposes. Each of optical assemblies 1900, 1950 produces a similar field of view, but the distal entrance pupil 1966 created by the latter optical assembly 1900, 1950 is moved distally towards the patient compared to the distal entrance pupil 1934. Thus, the beam cone does not cut the attached speculum tip element 1124 and allows the caregiver to still see the tympanic membrane all at once, but no portion of the speculum tip element 1124 will appear in the resulting image.

Surprisingly, thanks to the above-described optical system, the applicant has further found that the attached speculum tip element can be made optically transparent, as opposed to the typically black opaque version of these elements. The final spot produced was clear, crisp and well defined with no edge effects.

Fig. 56 schematically illustrates another alternative optical assembly 1980 based on material changes (distal entrance pupil 1966, fig. 55) that produce a similar overall effect on the resulting image of the medical target. In optical assemblies 1900 and 1950, each optical element is made of moldable plastic, while the optical element according to the latter optical assembly 1980 is made of glass. More specifically, for each of the objective lens 1982, the relay lens 1984, and the eyepiece lens 1986, two (2) glass lenses are used instead of the plastic aspherical lens, wherein the two glass lenses achieve image quality by two opposing convex lenses having a high refractive index (greater than 1.80) and an abbe number greater than 35. Optical assembly 1980 also includes a flat window 1988. It will be appreciated that similar configurations are also possible.

Ophthalmoscope

The following portion of the specification relates to the design of another body evaluation device made in accordance with various exemplary embodiments. More specifically, the physical evaluation device is an ophthalmic device configured for examining an eye of a patient. However, it will be appreciated by those skilled in the art that certain inventive aspects described herein may be applied to a variety of other medical examination or diagnostic devices.

Referring to fig. 57(a) and 57(b), the ophthalmoscope 2000 includes an instrument head 2004, the instrument head 2004 being releasably supported at an upper end of a handle or handle portion 2008 using a snap or similar connection, the handle portion 2008 enabling the instrument 2000 to be portable and configured for handheld use. The handle portion 2008 includes at least one housed battery (not shown) for powering a light source (i.e., LED-not shown) provided in the instrument head 2004. Further, a varistor 2020 is included in the rotatable portion of the handle section 2008, the varistor 2020 being configured to control the amount of illumination of the light source and the depressible switch button 2022. The housed battery is preferably rechargeable, with the lower portion of the handle portion 2008 including a charging port 2024.

The instrument head 2004 is defined by a distal (patient) end 2010 and an opposite proximal (caregiver) end 2014, and is further defined by an interior portion sized and configured to hold a plurality of components. As described in more detail below, the distal end 2010 of the instrument head 2004 receives a deformable eye shield 2030, while the proximal end 2014 of the instrument head 2004 includes an adaptor interface member 2040, similar to the adaptor interface member 180 of fig. 2(a) and the adaptor interface member 1224 of fig. 30, to enable releasable attachment of the smart device adaptor 300 of fig. 6-13 (b). The instrument 2000 further includes a rotatable diopter wheel 2050 supported between mating front and rear housing portions 2210, 2214, and a rotatable aperture wheel 2060, the aperture wheel 2060 being disposed at a lower portion of the instrument head 2004, and a portion of the aperture wheel 2050 extending outwardly from a shaped slot provided in the front housing portion 2210.

The optical assembly and the illumination assembly are generally retained within the instrument head 2004. In accordance with this embodiment and referring to fig. 58, 59(a) and 59(b), the most distal component of the optical assembly is an objective lens 2240, which is mounted near the distal end 2010 of the instrument head 2004. A rear peripheral edge 2242 of objective lens 2240 is secured to an annular shoulder 2245 formed in instrument head 2004 and is held in place by an end cap 2248, which end cap 2248 is threadably positioned on the distal end of front housing section 2016, with end cap 2248 having a corresponding set of threads 2249. After fixation, end cap 2248 is also configured to hold fixation target holders 2254, the fixation target holders 2254 being arranged circumferentially around objective 2240. O-ring 2260 forms a seal between objective 2240 and fixed target holder 2254.

An angled slot is provided on the front surface of the fixation target holder 2254 that receives a polarizer window 2256 (shown only in exploded view 58), which polarizer window 2256 may be formed of different colors (i.e., blue, red) for directing a pair of fixation targets toward the patient according to this embodiment. Polarizer window 2256 is positioned at the distal (objective) end 2010 of instrument head 2004, with the slots disposed on diametrically opposite (left/right) sides of objective 2240 where the fixed illumination target is located. When the patient is looking at a fixed target in the opposite direction relative to the eye being examined (i.e., either the right eye is looking at the left target or the left eye is looking at the right target), the patient's eye will place their optic disc near the center of the view in approximately 17 degree alignment. According to this embodiment, a set of optical fibers (not shown), preferably with polished ends, extend from the received LEDs 2356 of the illumination assembly of the ophthalmoscope 2000 to each fixation target. More specifically, the polished distal end of the fiber is placed in contact with the polarizer window 2256, with the fiber passing upwardly from the LED 2356 through the interior of the instrument head 2004, with the LED 2356 remaining in the lower portion of the instrument head 2004. According to this embodiment, the proximal end of the fixation target fiber is disposed to the side of the LED 2356, although other suitable configurations may be employed to effectively direct the desired illumination to the distally disposed fixation target.

The proximal end of eye shield 2030 is disposed above distal end 2010 of instrument head 2204 and surrounds contained objective 2240 to create a suitable working distance, according to this embodiment about 25mm, between body evaluation device 2000 and the patient's eye. Eye shield 2030 is made of an elastomeric material and is shaped and configured to allow the distal end of the eye shield to be placed over the patient's eye. The proximal end of eye shield 2030 includes at least one internal engagement feature and is shaped to be releasably and securely attached to end cap 2248, which is also suitably shaped and configured for this engagement.

At the proximal end 2014 of the instrument head 2004, the housed optical assembly includes an eyepiece holder 2270 that projects outwardly (proximally) from the instrument head 2004 and is housed within the adapter interface member 2040. According to this embodiment, the eyepiece holder 2270 is defined by an open-ended structure that holds a pair of eyepiece lenses 2280, 2284, each separated by an appropriate distance by an intermediate eyepiece spacer 2288. The eyepiece lenses 2280, 2284 are held proximally relative to the field stop holder 2290 with the eyepiece holder 2270 threadably engaged within an opening formed in the adapter interface member 2040. A field stop 2297 is held within the narrowing portion 2299 of the field stop holder 2290, the field stop 2297 being aligned with the eyepieces 2280, 2284 and the objective lens 2240 along a defined optical axis of the apparatus 2000.

A relay lens 2286 and an aperture stop 2291 are disposed between the proximal end 2010 and the distal end 2014 of the body evaluation device 2200 described herein, the relay lens 2286 being aligned along a defined visual axis, each of the aforementioned optical components being disposed intermediate the interior of the instrument head 2004 as part of an optical assembly. The relay lens 2286 is retained within the relay lens holder 2287, and more specifically, within a bore sized to retain the relay lens 2286 and align with the remaining optical components along a defined optical axis. The polarizer window is disposed immediately distal to the supported relay lens 2286. A relay lens holder 2287 is attached to the proximal end of top optical base member 2426.

With respect to the illumination assembly and referring to fig. 58, 59(a) and 59(b), the instrument head 2004 further retains a plurality of components configured for illuminating the patient's eye. The electrical contact pins 2320 are disposed within a hollow plastic insulator 2328, the hollow plastic insulator 2328 having an upper portion sized and configured to retain a coil spring 2332 for biasing the contact pins 2320. A coil spring 2332 is preferably disposed between the top or upper portion of electrical contact pin 2320 and a shoulder formed in the upper portion of insulator 2328.

When the lowermost end of contact pin 2320 is engaged with an electrical contact (not shown) in the handle (not shown) of body evaluation device 2000, the top end of contact pin 2320 is pressed into contact with the lower surface of printed circuit board 2350, printed circuit board 2350 for LED 2356 disposed on the upper surface of circuit board 2350. Circuit board 2350 is positioned on a circuit board holder 2330, which circuit board holder 2230 further holds an insulator 2328 and contact pins 2320, circuit board holder 2330 has a set of external threads 2331 which engage a corresponding set of threads provided within optical base member 2390. As described herein, circuit board 2350 can be configured with LED drive circuitry that can be compatible with various instrument handles, including handles typically configured for driving incandescent light sources. This circuit is described in the latter part of the application.

For purposes of this embodiment, the LEDs 2356 are aligned with the condenser lens 2364 along a defined illumination axis, the condenser lens 2364 is held within a lens holder 2380, which lens holder 2380 is snap fit in a manner that creates alignment with the LEDs 2356. Each of these components is then further retained in an optics base 2390, where optics base 2390 is mounted in the lower neck portion of instrument head 2004.

According to this embodiment, the aperture wheel 2060 is disposed above the condenser lens 2364 and is supported by the optical base member 2390 so as to rotate. A slot is provided in the front housing portion 2016 to allow access to an aperture wheel 2060, which aperture wheel 2060 is configured for rotational movement to selectively position each of a series of circumferentially spaced holes formed in aperture plate 2404 in alignment with LED 2356 and condenser lens 2364 along a defined illumination axis. A pair of cover portions 2062, 2064 hold rotatable aperture wheel 2060 within the recess of optical base member 2390. The cover portions 2062, 2064 hold the end of the shaft 2065, which extends through the centers of the aperture wheel 2060 and the aperture plate 2404 so as to be rotatable. More specifically, a plurality of windows are circumferentially disposed on the aperture wheel 2060, which may include a red-free filter, a blue filter, and a variable-sized aperture. Various other configurations may be readily implemented.

Above aperture wheel 2060 and optical base member 2390, the illumination assembly further includes a relay lens 2420, the relay lens 2420 according to this exemplary embodiment being retained within the upper end of optical base member 2390 and aligned with the condenser lens 2364, rotatable aperture wheel 2060 and LED 2356 along the defined illumination axis.

Polarizing window 2440 is held on the top surface of optical base member 2390, and optical base member 2390 is held above and distal with respect to relay lens 2420 and with respect to mirror 2450, which is supported by mirror mounting assembly 2453. Compression springs 2395 of fig. 60(a) are provided between top optical base member 2426 and the upper portion of optical base member 2390 to maintain pressure against polarizer window 2440 and relay lens 2420 of the illumination assembly, where the lower end of optical base member 2426 is received but not secured within the upper portion of optical base component 2390. The foregoing arrangement further maintains the alignment of the relay lens 2286 and relay lens holder 2287 of the optical assembly of the device 2000 described herein, wherein each lens is held in the top optical base member 2426 as previously discussed.

Referring to fig. 58, 59(b), and 60(a) -60(d), the mirror mounting assembly 2453 includes an elongated base 2454 having an upper end 2455 and a lower end 2456. The lower end 2456 of the nosepiece 2454 holds the nosepiece 2454 along the inclined support surface 2451. The bezel 2454 is pivotally supported within a housing 2458, which housing 2458 is provided within a top optical base member 2426. An adjustment member 2462 (e.g., a threaded fastener) extends into a shaped slot within the rear housing portion 2018 of the instrument head 2004 and further into the upper portion 2459 of the housing 2458. The distal end of the adjustment member 2462 is configured to engage a rear surface 2457 at the top of the nosepiece 2454, thereby pivoting the nosepiece 2454 and enabling the angle of the supported mirror 2450 to be adjusted to direct light from the LED 2356 of FIG. 59(b) toward the distal end of the instrument head 2004.

A nub 2466 made of an elastomeric material (e.g., polyurethane foam (poron)) is also mounted within the top of the housing 2458, with the nub 2466 abutting the front face of the mirror base 2454 that it engages. Referring to fig. 60(c), the housing 2458 according to this embodiment is defined by a generally cylindrical upper portion 2459 and a pair of lower extension legs 2460 that pin-connect the lower end 2456 of the retention bezel 2454. The upper end 2459 of the housing 2458 includes a threaded sleeve 2461 that aligns with a rear surface 2457 of the top of the mirror base 2454 that receives the adjustment member 2462. Housing 2458 according to this embodiment is supported within top optical base member 2426 along with a sealing member, such as O-ring 2470. According to this embodiment, adjustment member 2462 allows lateral adjustment of the held mirror 2450 in addition to angular (pivotal) adjustment of the mirror mount 2454, wherein an O-ring 2470 in contact with the inner surface of optical base member 2426 provides sufficient resistance to maintain lateral adjustment of the supported mirror 2450.

Referring to fig. 59(b), the illumination assembly allows light from the housed LEDs 2356 to be directed along a defined illumination axis through the aligned condenser lens 2364, aperture wheel 2060, relay lens 2420 and polarizer window 2440 to the supported mirror 2450. A reticle (not shown) may further be provided as part of the aperture wheel or otherwise provided within the optical base member. The light is then further directed toward the distal end 2012 of the instrument head 2004, more specifically through objective lens 2240, and where the light is focused at the pupil edge of the patient's eye. The position of objective 2240 may be appropriately adjusted at the time of manufacture to further counteract any tolerance mismatch other than the adjustment of the supported mirror by the mirror mounting assembly.

Referring to fig. 59(a), light reflected from the back of the patient's eye is directed through objective 2240 to the distal end of the ophthalmoscope 2000, the light in objective 2240 is then focused onto relay lens 2286, and relay lens 2286 directs the light through field stop 2297 and imaging lenses 2280, 2284 to the clinician's eye (not shown) or to an attached smart device attached to adapter interface member 2040. The adapter interface member 2040 according to this embodiment is similar in structure to the adapter interface member 180 of fig. 6-13(b) and requires no additional discussion.

Shape-changing ophthalmoscope

As shown in fig. 61, an ophthalmoscope 3100 constructed in accordance with another exemplary embodiment is described herein. As discussed herein and shown in fig. 65, the ophthalmoscope 3100 includes an instrument head 3104 releasably attached to the upper end of a handle portion 3108. The instrument head 3104 is defined by a distal (patient) end 3112 and an opposite proximal (caregiver) end 3116. The inner portion 3105 of the instrument head 3104 is sized and configured to hold an illumination assembly 3101 and an optical assembly 3102.

According to this form and as shown in fig. 62 and 63, the eye flap 3120 is attached to the distal end 3112 of the instrument head 3104. According to this embodiment, the eye flap 3120 is a flexible member, preferably made of an elastomeric material designed for direct engagement with the patient. When attached, the ocular flap 3120 establishes a working distance between the patient's eye and the first most distal lens component of the housed optical assembly.

The eyecup 3120 according to this embodiment is defined by a solid continuous member. In alternative embodiments, the eye shield may include one or more slits or openings (not shown) that do not compromise structural integrity for patient alignment purposes.

According to an embodiment and as shown in fig. 64(a) and 64(b), a disposable ring member 3124 can be provided that is configured and dimensioned to fit within the distal opening 3122 of the eye flap 3120. More specifically, the disposable toroidal member 3124 is defined by a flexible material (e.g., a foam material or polypropylene) and is defined by opposing distal and proximal openings 3125, 3127, wherein the distal opening 3125 includes an external toroidal flange 3129. When attached, the disposable ring member 3124 may be inserted into the distal opening 3125 of the eye flap 3120 while the external annular flange 3129 of the disposable ring member 3124 forms a stop.

According to one embodiment, the user may load the disposable ring member 3124 from a set of stacked rings (not shown) into a container (not shown) having an open top and engaging the distal end of the eye flap 3120 with the disposable ring member 3124 until the distal end of the eye flap 3120 engages the external annular flange 3129 of the disposable ring member 3124. The compression of the eye flap 3120 creates a secure engagement between the inner portion of the eye flap 3120 and the outer surface of the disposable ring member 3124, allowing the disposable ring member 3124 to remain attached to the eye flap 3120 when the eye flap 3120 is removed from the container. Advantageously, the disposable ring member 3124 can be attached without having to contact the ring member 3124, and wherein the disposable ring member 3124 allows for reuse of the eyewear 3120 as shown. The disposable ring member 3124 also acts as a stop, preventing the eyecup 3120 from being pressed completely against the patient's eyes.

Referring to the cross-sectional view shown in fig. 65, the instrument head 3104 according to this embodiment is manufactured using a two-part housing made of a front housing part 3109 and a rear housing part 3110 fitted to each other. The instrument head 3104 is defined by an interior space 3105, the interior space 1055 being sized and configured for holding a plurality of components including an optical component 3101 and an illumination component 3102. As exemplarily shown in fig. 66-68, the optical assembly 3101 includes a plurality of optical components or elements disposed and aligned along a defined visual or optical axis 3132, the visual or optical axis 3132 extending through the patient's eye 3130 and the distal and proximal ends 3112 and 3116 of the device 3100. As previously mentioned herein, "optical component" or "optical element" refers to lenses and prisms as well as field stops, aperture stops, polarizers, and any component for directing or transmitting light along a defined optical or visual axis.

According to this embodiment, the most distal component of the optical assembly is the objective 3140, which is mounted near the distal end 3112 of the instrument head 3104. As shown in fig. 65, the rear peripheral edge 3142 of the objective lens 3140 is secured to an annular shoulder 3145 formed in the instrument head 3104 and is secured in place by an end cap 3148, which end cap 3148 is threadably positioned on the distal end 3112 of the instrument head 3104. When secured, the end cap 3148 is also configured to hold a fixed target holder 3154, the fixed target holder 3154 being circumferentially disposed about the objective lens 3140, and as further shown in fig. 69. An angled slot is provided on the front face of the fixed target holder 3154 that receives a polarizer window according to this embodiment, which may be formed of different colors (i.e., blue, red) for guiding a pair of fixed targets to the patient.

As shown in fig. 69, the objective end of the instrument head 3104 is shown with two slots on each side (left/right) of the lens 3140 where the fixed illumination target is located. When the patient is looking at the target in the opposite direction to the eye being examined (i.e., either the right eye is looking at the left target or the left eye is looking at the right target), the patient's eyes will align with the optic disc near the center of the field of view at a position of approximately 17 degrees. According to this embodiment, a set of optical fibers, preferably with polished ends, extends from the accommodated LEDs to each fixation target. More specifically, the polished distal end of the optical fiber is placed in contact with the polarizer window, where the optical fiber is guided through the interior of the instrument head and down to the housed LED. According to this embodiment, the proximal end of the fixation target optical fiber is disposed on the side of the LED, but other configurations may be employed.

The proximal end of the eye flap 3120 is disposed on the distal end 3112 of the instrument head 3104 and is disposed around the housed objective lens 3140 to create a suitable working distance between the device 3100 and the patient, as shown in fig. 66, which is about 25mm according to this embodiment.

The proximal end 3116 of the instrument head 3104 includes an eyepiece holder 3170 that protrudes outward (proximally) from the instrument head 3104. According to this embodiment, eyepiece holder 3170 is defined by an open-ended structure that includes an annular shoulder 3172 formed on an outer (proximal) side, eyepiece holder 3170 being sized and configured to hold forehead holder 3176 for use by a clinician. Eyepiece holder 3170 holds a pair of eyepiece lenses 3180, 3184 separated by an appropriate distance by eyepiece spacer 3188. The eyepiece lenses 3180, 3184 are held in a field stop holder 3190, the field stop holder 3190 being threadedly engaged within openings formed in the eyepiece mount 3170 and the instrument head 3104. The field stop 3197 is held within a narrow portion 3199 of the field stop holder 3190 and is aligned with the eyepiece lenses 3180, 3184 and the objective lens 3140 along a defined optical axis.

Disposed between the proximal end 3112 and the distal end 3116 of the device 3100, and referring to fig. 65-68, the optical assembly 3101 described herein further includes a relay lens 3186 aligned along a defined viewing axis 3132, and an aperture stop 3191, each of the relay lens 3186 and the aperture stop 3191 disposed intermediate an interior 3105 of the instrument head 3104.

The components of the optical assembly 3101, including the objective lens 3140, the aperture stop 3191, the relay lens 3186, the field stop 3197, and the eyepiece lenses 3180 and 3184, are shown in respective arrangements according to fig. 66-68, each aligned along a visual axis 3132 relative to the clinician's eye (not shown) when brought onto the forehead rest 3176, or as shown in fig. 62, aligned relative to the interface and imaging aperture of the attached smart device 3106.

With respect to the illumination assembly 3102 and referring to fig. 70, the lower neck portion 3107 of the instrument head 3104 includes a plurality of components configured for illuminating an object of interest (an eye). The electrical contact pin 3220 is disposed within an opening 3224 formed in a plastic insulator 3228 having an upper portion 3229, the upper portion 3229 retaining a coil spring 3232 for biasing the contact pin 3220. A spring 3232 is disposed between a top or upper end 3224 of the contact pin 3220 and a shoulder 3238 formed in an upper portion 3229 of the insulator 3228.

When the lowermost end of the contact pin 3220 is engaged with an electrical contact (not shown) in the handle (not shown) of the body assessment device 3100, the tip 3224 of the contact pin 3220 is pressed into contact with the lower surface of the printed circuit board 3250 of the LED 3256, the LED 3256 being disposed on the upper surface of the circuit board 3250, as best shown in fig. 70. The circuit board 3250 is positioned in place on a circuit board holder 3230, the circuit board holder 3230 further holding the insulator 3224 and the contact pins 3220, the holder 3230 having a set of external threads that engage corresponding threads provided in the assembly support member 3290.

The LED 3256 is aligned with the condenser lens 3264 along the illumination axis 3310 of fig. 66, the condenser lens 3264 is held within a lens holder 3280, and the lens holder 3280 also holds a centering ring 3281 aligned with the LED 3256. Each of these latter assemblies is also held within an assembly support member 3290, the assembly support member 3290 being mounted within the lower neck portion 3107 of fig. 65, 70 of the instrument head 3104.

Referring to fig. 65 and 70, an aperture wheel 3300 is disposed above the condenser lens 3264. The aperture wheel 3300 is supported by the assembly support member 3290 and is configured for rotational movement so as to selectively position and position each of a series of circumferentially spaced apertures formed in the aperture plate 3304 in alignment with the LEDs 3256 and the condenser lenses 3264 along the defined illumination axis 3310 of fig. 67. More specifically, a plurality of windows 3304 are circumferentially disposed on the aperture wheel 3300, which includes a red-free filter, a blue filter, and a variable-sized aperture. It will be readily apparent that various other configurations may be readily implemented.

Referring to fig. 65 and 67, and above the aperture wheel 3300 and the assembly support member 3290, the lighting assembly further includes a relay lens 3320 according to this embodiment, the relay lens 3320 being held in a holder 3326. According to this embodiment, the relay lens holder 3326 is threadably secured to an upper portion of the assembly support member 3290 and is aligned with the condenser lens 3264, aperture wheel 3300 and LEDs 3256 along a defined illumination axis 3310.

Referring to fig. 66-68, the optical and illumination assembly components of the body evaluation device are shown in schematic form for clarity. As noted, the optical assembly 3101 includes an objective lens 3140 aligned with eyepiece lenses 3180, 3184 and field stop 3197, and a relay lens 3186 and aperture stop 3191, each aligned along a defined optical axis 3132. In addition, diopter wheel 3200 supports a plurality of optical elements 3204 of varying power sources (concave/convex). Diopter wheel 3200 is rotatably movable into and out of a defined visual axis 3132 to establish a focal point of the patient's eye 3130.

Still referring to fig. 67, the illumination assembly 3102 includes an LED 3256 aligned along a defined illumination axis with a condenser lens 3264 and a rotatable aperture wheel 3300 and an illumination relay lens 3320, each of which is disposed in alignment with an angled mirror 3350, the mirror 3350 being offset relative to an imaging axis 3132.

According to this embodiment and as shown with reference to fig. 71(a) and 71(b), the mirror support member 3354 may be threaded into a shaped port at the top of the instrument head 3104. The mirror 3350 is attached to a pivotable portion 3360, which pivotable portion 3360 is accessible and can be adjusted during manufacture. According to one form, the mirror 3350 may be adjusted using an adjustment member 3352, which adjustment member 3352 may be accessible through a port formed in the rear of the instrument head 3104. The mirror 3350 is also attached to a movable member that enables additional adjustment of the supported mirror 3350 as needed. The mirror mounting assembly described is exemplary. For example, the mirror mounting assembly 2453 (see fig. 60(a) -60(f)) described in the previous embodiment may be substituted for this form.

For purposes of this embodiment, the lighting assembly 3101 utilizes a single LED 3256, but the number of LEDs and color temperature may be varied as appropriate. According to this embodiment, a magnifying lens 3210 is provided near the window of the neck 3107 to allow the caregiver to more easily read the diopter wheel settings of the ophthalmic device 3100 described herein.

Fig. 67 illustrates an illumination light trace of an instrument 3100 described herein. According to this embodiment, and upon engagement between the lower ends of the contact pins and a battery (not shown) housed in the instrument handle (not shown), the housed LED 3256 is energized. The output of the LED 3256 passes through the centering ring 3251, the condenser lens 3260 and the aperture wheel 3300 along a defined illumination axis 3310, where the light beam passes through the relay lens 3320 and the polarizer 3340 and is directed towards the folded mirror 3350, the position of the mirror 3350 being adjustable within the mirror base during manufacture by using a threaded adjustment member.

Although the imaging elements of the assembly are also shown in this view, light does not pass through imaging axis 3132. In addition, and also not shown, a portion of the emitted light is directed through the instrument head 3104 through a set of optical fibers (not shown) and to a fixed target positioned at the distal end 3112.

Still referring to fig. 67, light emitted from the LED 3256 is reflected from an angled mirror 3350, the mirror 3350 having an angled surface that directs the light toward the distal end 3112 of the instrument head 3104, and more particularly through the objective lens 3140. The reflected light passes through the objective lens 3140 and is then focused onto the patient's eye 3130. According to this embodiment, the focus of the reflected light is off-center with respect to the front of the patient's eye 3130 (more specifically, acting as the pupil where the image is flat), and then the light spreads out to the back of the eye, and more specifically, to the retina 3137. As shown and described herein, the focus point is offline with respect to the optical axis 3132 of the device 3100.

Referring to fig. 66 and 68, an image of the target (i.e., retina 3137) is reflected from the back of the eye 3130 to the objective lens 3140, where the light is further directed along a defined optical axis 3132 through an image aperture plate 3188, where the inverted image passes through the image aperture plate 3188. The light is then directed to a relay lens 3186, field stop 3197 and through eyepiece lenses 3180, 3184, respectively, where it is focused as an erect image on the eyes of the caregiver (not shown).

Alternatively and in lieu of an eyepiece, light may be directed through a hole of a smart device 3106 (e.g., a smart phone) of fig. 62, the smart device 3106 being attached to the proximal end 3116 of the device 3100 and aligned relative to the optical axis 3132. Such attachment may be accomplished in the manner previously described with respect to fig. 6-13(b) or in accordance with the alternative techniques described in fig. 14-20.

Fig. 73 illustrates an optical layout illustrating the scaling of instrument heads 3404, 3414 such as illustrated in fig. 74. More specifically, instrument heads 3404, 3414 may include a scaled optical assembly that holds a rear end that typically includes relay lenses 3440, 3444 and eyepiece lenses 3448, while axially adjusting positions and scaling of objective lenses 3424, 3434 and aperture plates 3427, 3437, the rear end enabling a universal interface for various body assessment equipment.

The benefits of the optics of the illumination assembly are shown in fig. 75. At the top of the figure is a known ophthalmic illumination assembly where the position of the condenser lens (where the focus distance is) creates a potential problem where dust or debris on the condenser lens can interfere with the final inspection. The lower part of the figure shows the point focus relative to the front and back surfaces of the condenser lens, which effectively eliminates this problem while keeping the reticle plane focus at infinity.

A general need in the field of diagnostic medical care is to enhance versatility and interchangeability between physical evaluation devices (e.g., otoscopes and ophthalmoscopes). According to one embodiment, shown in fig. 76(a) and 76(b), the ophthalmoscope may be reconfigured to allow examination of a patient's eye. The ophthalmoscopes 3450, 3470 depicted in these figures are model 117 ophthalmoscopes and model 12800 pocket-sized ophthalmoscopes, respectively, commercially available from Welch Allyn corporation of skaneateles falls, new york. According to this exemplary embodiment, each of instrument heads 3454, 3474 is configured to allow otoscopy. More specifically, a tip attachment and release mechanism is mounted into the distal end 3456, 3476 of each ophthalmoscope 3450, 3470 such that the disposable speculum tip element 120 is releasably retained at the distal end as a patient interface in place of the eyecup. For the purpose of this conversion, each existing instrument head 3450, 3470 may be configured with a distal insert and distal ring member similar to those in otoscope 100 of 2(b) described previously.

In use and for close viewing purposes, the existing diopter wheels 3462, 3482 of each ophthalmoscope 3450, 3470 may be used to provide adjustment at a setting of about 10-15 diopters, based on the caregiver's individual vision and application/use. Each operation is performed using a rotatable diopter wheel common to known ophthalmoscopes.

According to another form, the speculum tip attachment mechanism may be mounted onto the distal ends 3456, 3476 of the instrument heads 3452, 3472 so as to preset the angle of the attached tip element 120 relative to the accommodated light source. Advantageously, this preset position of the attached speculum tip may optimize the uniformity and concentricity of the illumination light from the included light source in the handle portion of each of the depicted instruments 3450, 3470.

LED drive circuit

Current instrument heads, such as those commercially sold by Welch Allyn, are based entirely on halogen lamps. Electrically, the filament is a wire whose resistance increases with temperature. Thus, for any given input voltage, the filament heats up, which increases its resistance until the driving circuit reaches a natural equilibrium (heat/light/resistance/current for a given input voltage). When the input voltage increases, the filament becomes bright, and when the input voltage decreases, the filament becomes dark.

In contrast, all known LED controller ICs in the electronics industry are designed to ignore their input voltage. There are many justified reasons for doing so, but it is critical that a system that varies the voltage as a control light output is by definition absolutely incompatible with LED technology. Therefore, it is not recommended to change/reduce the LED brightness by changing its input voltage. With both light sources integrated into the instrument head, a solution is needed to drive and dim the halogen and LEDs.

Thus, fig. 77-81 depict exemplary embodiments of circuitry for controlling LED illumination in an instrument head. Embodiments disclosed herein provide a number of improvements over conventional lighting control circuits. For example, a typical instrument head is only compatible with a particular instrument handle, as the instrument handle provides power to the instrument head, and the power must be provided at a very specific voltage and current profile. Thus, instrument heads often cannot be used with different instrument handles, requiring a large number of instrument heads and designs.

For example, different types of lighting have different electrical characteristics. For example, dimming of LED lamps can be achieved by a constant voltage and hence a constant current that is pulse width modulated to reduce the duty cycle at which the LED is turned on, while dimming of incandescent lamps can be achieved by varying the voltage. In addition, conventional instrument heads may include an Alternating Current (AC) power source and may be compatible only with lighting devices that may use AC power, such as incandescent or halogen lamps. In addition, different instrument handles may be wired with different polarities, requiring the instrument head to be hardwired to accept a particular polarity. In addition, LEDs and LED driving circuits have stringent requirements on polarity. Current instrument handles have multiple polarities (+/-, -/+ and ac), so the input power must be rectified to a single polarity before driving the LEDs in the instrument head.

Advantageously, the circuits disclosed herein are designed to address these issues by allowing compatibility between different instrument heads and instrument handles.

Fig. 77 depicts a block diagram of a circuit 3510 for controlling or driving LED lighting. The circuit 3510 may be disposed within an instrument head, such as the instrument head 104 of the otoscope of fig. 1(a) -5 or the instrument head 2004 of the ophthalmoscope of fig. 59(b), that provides power and has buttons for controlling illumination (including turning on or off, dimming, brightening, etc.). The circuit 3510 includes a controller 3514, a buck/boost or power supply circuit 3516, and a rectifier circuit 3518. The circuit 3510 may be connected to the instrument handle 3512, and such connection may be through a 2-wire connection, a 3-wire connection, or any other suitable connection having multiple wires for voltages and/or signals. Working examples of specific embodiments of the controller 3514, the power supply circuit 3516, and the rectifier circuit 3518 are discussed below with reference to fig. 79-81.

Fig. 78 is a flow chart describing a method 3500 for controlling LED illumination in an instrument head by using the circuit 3510 of fig. 77. Referring to fig. 77-78, in one example, at block 3520, an instrument handle 3512 can be connected to an instrument head (such as instrument head 104 of the otoscope of fig. 1(a) -5 or instrument head 2004 of the ophthalmoscope of fig. 59 (b)), where the instrument head includes circuitry 3510. The connection may be by 2-wire, 3-wire or other suitable connection. In one example, a simple 2-wire connection would only allow instrument handle 3512 to provide electrical power (e.g., at a particular voltage and current) to electrical circuit 3510. In another example, the instrument head may include one or more wires (e.g., a serial port) with control signals for transmitting control signals from the instrument handle 3512 to the circuitry 3510. The signal received by the circuit 3510 from the instrument handle 3512 may be an alternating voltage or direct voltage signal having varying voltage and/or current levels.

Based on the signals received by the circuitry 3510 from the instrument handle 3512, at block 3530, a power curve of the instrument handle 3512 may be determined. For example, the controller 3514 of the circuit 3510 may be programmed to sense voltage, current, polarity, and other signals from the instrument handle 3512 and use the signals to determine which type of instrument handle is actually connected.

For example, conventional instrument handles may be designed to use voltage variation to control dimming of a halogen or other incandescent lamp. In this case, electrically, the filament is a wire whose resistance increases with temperature. Thus, for any given input voltage, the filament heats up, which increases its resistance until the driving circuit reaches a natural equilibrium (heat/light/resistance/current for a given input voltage). When the input voltage increases, the filament becomes bright, and when the input voltage decreases, the filament becomes dark. In contrast, all LED controller ICs in the electronics industry are designed to ignore their input voltage. There are many justified reasons for doing so, but it is critical that a system that varies the voltage as a control light output is by definition incompatible with LED technology. Therefore, it is not recommended to change/dim the LED brightness by changing its input voltage. By incorporating both light sources into the instrument head, the present circuitry 3510 allows for the driving of both an LED light source and an incandescent light source from a single instrument handle 3512. Thus, the controller 3514 may sense the above characteristics and determine that the attached instrument handle is of the type typically used to drive halogen or other incandescent lights, but that the instrument handle now requires driving LED lighting.

With continued reference to the method 3500 of fig. 78, at block 3540, the circuit 3510 may be configured to operate at the power curve determined at block 3530. The configuration may include configuring the controller 3514 and/or the power circuit 3516, as explained in more detail below with respect to fig. 79-81.

Advantageously, based on the automatic detection of handle characteristics, the circuit 3510 is configured to operate with the instrument handle 3512, which allows any number of different instrument handles that have been employed in the field to be used with the new instrument head described herein. Thus, advantages such as features of LED illumination may be realized even without replacing these previously employed instrument handles. This automatic detection and configuration of the instrument head for the instrument handle represents an improvement in the field of medical devices because the technology allows a clinician or other caregiver to mix and match different handles and instrument heads, thereby increasing the efficiency of treating a patient.

Next, at block 3550, the instrument handle 3512 may be used to operate and control the LED lights of the instrument handle driven by the power circuit 3516. To facilitate operation and control of the LED lighting with different instrument handles 3512 (which may have widely different electrical characteristics), the power circuit 3516 includes buck-boost voltage conversion that allows for conversion of a variable input voltage to a specified output voltage, where the input voltage may be higher or lower than the specified output voltage. The buck portion of power supply circuit 3516 reduces the higher input voltage to meet the lower specified output voltage requirement, while the boost portion of power supply circuit 3516 increases the lower input voltage to meet the higher specified output voltage requirement. The details of the power supply circuit 3516 are set forth with reference to fig. 80. In addition, operating and controlling the LED illumination with the instrument handle 3512 is also accomplished by converting the change in voltage to a change in current (at block 3550), as will be described in more detail with respect to fig. 79-81.

Further, at block 3560 of method 3500, the controller 3514 may detect an idle state of the instrument handle. After detecting the idle state, the power supply of the instrument head can be turned off. Also, at block 3570, the controller 3514 may detect a vibration state of the instrument handle and may perform a particular action based on the state, such as turning off power to the instrument head.

Another problem identified by portable physical assessment devices is the theft of the instrument handle from the charging base. The controller 3514 is used to detect a change in state and may include an anti-theft mechanism. For example, if the instrument handle is not returned within a predetermined time interval, an audible alarm may be sounded from the charging base. In addition, an LED indicator may also be provided on the charging base after the alert feature is enabled.

The circuit design may provide a controller that generates an audible alarm if the robot handle is not returned to the charging base (e.g., base 1800 of fig. 52) within a specified time.

In another embodiment, the auto-close feature will close the instrument after a predetermined period of inactivity. In such an example, the controller is programmed with a timer. If the motion sensor subsystem connected to the controller fails to report any motion (counted by the timer) during that period, the system will shut down the instrument.

Fig. 79 is a circuit diagram of the controller 3514 and the accessory circuits. In the embodiment of fig. 79, controller 3514 may be a microcontroller of type CY8C4025LQI-S401, available from Cypress Semiconductor, san jose, california. In other embodiments, discrete logic elements may be employed in place of the microcontroller.

As shown in fig. 79, the controller 3514 is connected to the input voltage that has passed through the rectifier of fig. 81. A rectifier is required because the LEDs can be powered by direct current rather than alternating current. The rectified voltage is then input to a controller 3514, which then outputs a pulse width modulation signal LED _ PWM. As shown in fig. 81, the LED _ PWM signal is input to a buck/boost or power supply circuit 3516. The circuit may use any of a variety of PWM algorithms. For example, in conventional voltage-based dimming, a voltage versus brightness curve may be described that relates a given voltage to a given brightness. The linear relationship means that if the voltage is reduced by 50% from the nominal high voltage, the brightness will be reduced by 50%. To convert this to dimming the LED, a PWM signal that is on 50% of the time will power the LED half the time, thereby achieving 50% brightness.

In other embodiments, a non-linear relationship between voltage and brightness may be observed. In one example, calibration of a conventional handle and a conventional incandescent bulb may be performed such that the conventional handle may later be used with the novel instrument head of the present disclosure. For example, the calibration process may use a conventional handle connected to a conventional incandescent bulb, and the voltage of the conventional handle may be varied from a maximum to a minimum while measuring the percentage of brightness as a function of voltage. The resulting calibration data set correlates voltage to the expected brightness percentage of the conventional handle. This calibration curve can be loaded into the controls on the instrument head of the present disclosure so that the brightness control of the conventional handle will have the same effective results when using the new instrument head.

The controller will do this by detecting the input voltage from the handle and using a look-up table containing a calibration data set to find the appropriate desired brightness percentage. Then, the input voltage is not applied to the LED, but is down/up converted to generate a constant LED current. The brightness will be controlled by a PWM signal that turns the LED on and off so that the LED remains on for a desired percentage of the brightness time, and remains off for the remainder of the time. In this manner, many different conventional handles having different voltages may be evaluated to find calibration data for the instrument head described herein.

In one embodiment, the controller 3514 receives the input voltage VIN from the instrument handle and determines its polarity. Depending on the polarity of the voltage VIN received from the instrument handle and possibly other indicia (e.g., power-on signal, initial voltage, etc.), the controller may determine the power profile for a particular instrument handle, such as by listing all known instrument handles and their known polarities, initial voltages, power-on signals, etc. using a look-up table. In this case, the controller may determine which type of instrument handle has been installed, and may then obtain a voltage calibration curve for the instrument handle that correlates voltage to the output illumination level of the LED, as described above. The LED _ PWM signal from the controller can drive the PWM signal at the correct duty cycle (e.g., percent on to off) as appropriate to achieve the brightness of the LED that corresponds to the brightness that would be output by an incandescent instrument head if the same instrument head were connected to it and driven directly with voltage. In this way, input voltage variations have been converted to a constant current PWM signal of a particular duty cycle that can be used to power and dim LEDs. In another example, a particular pin on the instrument handle may carry identification or information exchange data to inform the instrument head which handle has been connected, allowing the controller to look up the pre-loaded power curve for that handle.

In one embodiment, controller 3514 may also determine a vibration/motion or idle state of the instrument head and/or handle and perform the appropriate actions as described above with respect to method 3500. In one example, the idle state may be determined by a lack of activity indicated by the motion sensor for a predetermined period of time, and the action may be to turn off the instrument. In another example, the motion of the instrument may be detected by a motion sensor and an idle timer may be reset or other subsystems may be turned on.

Fig. 80 is a circuit diagram of a buck/boost or power supply circuit 3516. In the example of fig. 80, the power supply circuit 3516 is based on the TPS63036 buck/boost converter U5, which supports receiving the LED _ PWM signal from the controller as described above. TPS63036 is available from Texas Instruments Inc (Texas Instruments Inc., Dallas, Tex., USA). In the circuit diagram of fig. 80, we see that the input voltage is fed into converter U5, which converter U5 is also controlled using EN and PWM _ LED signals from controller 3514 to apply a PWM curve to dim the LED lighting, as described above with respect to fig. 79.

In operation, buck/boost or power supply circuit 3516 may receive an input voltage VIN and provide an output voltage VOUT that produces a fixed or constant current for powering the LED lamp. In a particular example, the output voltage VOUT may be regulated using a TPS63036 converter by appropriately setting resistors R1 and R2. When set, buck/boost or power supply circuit 3516 will output a fixed or constant current to power the LEDs and the PWM _ LED conductors of controller 3514 will be used to provide the appropriate duty cycle for the PWM signal to achieve a particular brightness. In other examples, the buck and boost portions of the circuit may be implemented separately using discrete components instead of a single buck/boost converter. In this case, the circuit will boost VIN less than VOUT by the boost sub-circuit and buck or step down VIN greater than VOUT by the buck sub-circuit.

Fig. 81 is a circuit diagram of the FET full-wave bridge circuit 3518. Rectification of a single polarity is typically accomplished with a diode Full Wave Bridge (FWB). The diode FWB typically loses 1V to 1.4V during rectification. This is a significant fraction of the LED voltage (typically 2.7V). This ratio approximates the energy loss that the battery never emits light. To minimize the losses associated with the diode full wave bridge, a FET full wave bridge is introduced, as shown in fig. 81. The FET FWB design only loses about 50mV, depending on the current and the FET selected. The energy not lost is the energy available to emit light and increase the overall battery life of the device.

The FET FWB circuit design consists of two NFETs, two PFETs and the necessary capacitors. The FET full wave bridge has considerable ESD protection, typically implemented in a capacitor between the gate-source of each FET.

According to another embodiment and referring to fig. 82, an instrument head for a body assessment device is configured with a buck converter head design that is an LED controller circuit design that can efficiently drive LEDs with a PWM (Bang-Bang) power supply without the risk of instability (LED flicker).

For the power supply, a conventional RC-hysteretic oscillator (known in the electronic world as bang-bang) will be used. The power supply will drive the halogen burner and the LED instrument head with the buck converter. For buck converter LED driver heads, the brightness is controlled, although the input voltage is sufficient. For power supplies with varying output voltage (as the drive voltage decreases (darkens)), the buck converter eventually drains the margin and the LED is driven directly by the drive voltage (in series with the parasitic resistance of the controller and mechanical system). This occurs when the input voltage approaches VF of the LED plus the induced voltage of the controller plus parasitic IR losses. For a PWM power supply, Bang-Bang dimming effectively dims the LED as long as the output voltage is greater than the VF of the LED, and no instability (flicker) occurs. For the purposes of this particular embodiment, the circuit is a PAM2804 IC LED driver recommended by the manufacturer. PAM2804 is a suitable example of an LED driver IC as it will run to a suitable voltage of 2.5V. This is an anomaly because no high brightness LED has a forward voltage of 2.5V. The DC-DC converter IC PAM2312-ADJ with a capacity of 2.5V can be reused for LED driving by dropping its reference voltage from 0.6V to 0.1V.

An alternative drive circuit is shown in fig. 83, in which R25, R26 and R27 are additionally provided to enable trimming in order to adjust the LED effective forward voltage. This function enables many LEDs to run on the instrument head and handle in a representative manner.

LEDs and LED driving circuits have stringent requirements on polarity. Current instrument handles have multiple polarities (+/-, -/+ and ac), so the input power must be rectified to a single polarity before driving the instrument head LEDs.

Unipolar rectification is typically accomplished with a diode Full Wave Bridge (FWB). The diode FWB typically loses 1V to 1.4V during rectification. This is a significant fraction of the LED voltage (typically 2.7V). This ratio approximates the energy loss that the battery never emits light. To minimize the losses associated with the diode full wave bridge, a FET full wave bridge is introduced, as shown in fig. 82. The FET FWB design only loses about 50mV, depending on the current and the FET selected. The energy not lost is the energy available to emit light and increase the overall battery life of the device.

The FET FWB circuit design consists of two NFETs, two PFETs and the necessary capacitors. The FET full wave bridge has considerable ESD protection, typically implemented in a capacitor between the gate-source of each FET.

While 2 line voltage change input is a standard method for dimming halogen or incandescent lamps, it is a problem for LED circuits, as occurs in the commercial and residential lighting industries. The most important problem is the unstable loop stability, which causes the LED to flicker. This can be a serious problem in body assessment devices such as ophthalmoscopes, otoscopes etc. Industrial LED circuits rely on pulse width modulation to dim LEDs. In order to drive LEDs and halogen lamps from a single voltage varying power supply, an electrical solution must be designed.

The circuit design shown in fig. 83(a), 83(b) described herein will drive both the LED lamp and the halogen lamp from a single variable power supply and maintain loop stability so there is no risk of LED flicker.

The circuit design starts working at first power-on, the output of the comparator is low, and the PFET is turned on. Assuming that the LED voltage is approximately constant, the voltage across the power inductor is approximately constant. Thus, the current will rise at a linear rate. This produces a positive slope voltage ramp across the sense resistor. With the present circuit, the voltage divider "masks" the detection voltage to a low level (ratio Hyst Res/(Hyst Res X Feedback Res)) at the positive input of the comparator. When the positive input voltage of the comparator reaches VREF, the comparator output goes high, turning off the PFET. This is referred to as the "upper threshold" of the hysteresis circuit. The output swing immediately reverses the voltage divider, causing the sense current at the positive input of the comparator to be high instead of low. Therefore, the current must exceed the hysteresis circuit's lower threshold before the output goes low again before crossing + VREF. When the PFET is off (comparator output is high), current continues to flow through the inductor, through the capture diode, creating a negative slope across the sense resistance.

When the current reaches the lower threshold, the output goes low, turning on the FET and the loop continues. Since the rise and fall of the detection voltage ramp are almost linear, the average current will be + VREF/SENSESISTOR. In other words, given a triangular wave, there will be half the product above and below its mean value. The circuit is regulated and controlled. The only disadvantage is that the ripple current is high, but this is not relevant for the LED, especially because the actual frequency is much higher than the frequency that can be detected by the human eye. More importantly, adding the output capacitor (C17) of the hysteretic current source will reduce the ripple current and make the slope more linear. More importantly, however, there is no high gain closed loop that is most commonly used in power control circuits (including LED drivers). Since the oscillator is simply an inductor that charges and discharges the oscillator when two predictable thresholds are reached, the instability of the oscillator period eliminates the chance that a conventional controller is prone to sub-harmonic oscillation. In other words, the connected LED does not blink.

The described circuit is stable. The circuit also does not dim with the input voltage and therefore has no other advantages compared to conventional LED driver circuits. However, if the reference voltage varies with the input voltage, which is something that conventional power supplies (including LED controllers) cannot do without creating an unstable control loop, the LED current will vary with the input voltage. Unlike the case where the high gain control loop will change its many stability parameters as the input voltage and the reference voltage change, the hysteretic controller continues to fluctuate between the upper and lower thresholds, with the average being the reference voltage. A voltage divider is added to generate + VREF and the LED voltage will vary in proportion to + VIN.

As previously discussed, another problem identified by portable body assessment devices that require base charging is the problem of theft of the instrument handle from the charging base. It is another object of the invention described herein to provide an anti-theft mechanism to be included in a charging base.

Such theft detection may include an audible alarm from the charging base if the instrument handle is not returned within a predetermined time interval. In addition, an LED indicator may also be provided on the charging base after the alert feature is enabled.

The circuit design may provide a controller that generates an audible alarm if the instrument handle is not returned to the charging base (e.g., base 1800 of fig. 52) within a specified time. According to one form, four (4) pogo pins are provided in the charging base; a positive contact, two negative contacts and a contact for instrument handle detection. The handle detection contacts will trigger a time period once the instrument handle is removed, and the timer will stop the timer once the handle is replaced into the charging base. In addition, an LED indicator light on the charging base may illuminate to alert an individual that an anti-theft alarm has been activated. This LED indicator will flash/flash when an audible alarm is given. A switch may be provided on the base or charging base to enable/disable the alarm function. The switch may be recessed into the housing of the charging dock and may only be accessible by a special tool or other access feature, such as a small piece of metal (e.g., a paperclip). There may also be other types of switches to set a defined time to activate the alarm after the handle is removed.

Other variations and modifications of the inventive concepts described herein will be apparent based upon the foregoing description and further from the appended claims.

Appendix

The following materials relate to other views of a medical device made according to embodiments of the present invention, as follows:

FIG. A-1 is a perspective view of a medical device according to another embodiment;

FIG. A-2 is another perspective view of the medical device of FIG. A-1;

FIG. A-3 is a left side perspective view of the medical device of FIGS. A-1-A-2;

FIG. A-4 is a right side view of the medical device of FIGS. A-1-A-3;

FIG. A-5 is a front view of the medical device of FIGS. A-1 through A-4;

FIG. A-6 is a rear view of the medical device of FIGS. A-1 through A-5;

FIG. A-7 is a top view of the medical device of FIGS. A-1 through A-6;

FIG. A-8 is a bottom view of the medical device of FIGS. A-1 through A-7;

FIG. A-9 is another perspective view of the medical device of FIGS. A-1-A-8 with an attached handle;

FIGS. A-10 are perspective views of a medical device made in accordance with another embodiment;

FIGS. A-11 are another perspective views of the medical device of FIGS. A-10;

FIGS. A-12 are left side views of the medical devices of FIGS. A-10 and A-11;

FIG. A-13 is a right side view of the medical device of FIGS. A-10 through A-12;

FIG. A-14 is a front view of the medical device of FIGS. A-10 through A-13;

FIG. A-15 is a rear view of the medical device of FIGS. A-10 through A-14;

FIG. A-16 is a top view of the medical device of FIGS. A-10 through A-15;

FIG. A-17 is a bottom view of the medical device of FIGS. A-10 through A-16;

FIG. A-18 is another perspective view of the medical device of FIGS. A-10-A-17 with an attached handle;

FIG. B-1 is a perspective view of a medical device made in accordance with another embodiment;

FIG. B-2 is another perspective view of the medical device of FIG. B-1;

FIG. B-3 is a left side view of the medical device of FIGS. B-1 and B-2;

FIG. B-4 is a right side view of the medical device of FIGS. B-1-B-3;

FIG. B-5 is a front view of the medical device of FIGS. B-1 through B-4;

FIG. B-6 is a rear view of the medical device of FIGS. B-1 through B-5;

FIG. B-7 is a top view of the medical device of FIGS. B-1 through B-6;

FIG. B-8 is a bottom view of the medical device of FIGS. B-1 through B-7;

FIG. B-9 is a perspective view of the medical device of FIGS. B-1 through B-8 including the instrument handle;

FIG. B-10 is a side view of the medical device of FIGS. B-1 through B-9 including the instrument handle;

FIG. B-11 is a perspective view of a medical device made in accordance with another embodiment;

FIG. B-12 is another perspective view of the medical device of FIG. B-11;

FIG. B-13 is a left side view of the medical device of FIGS. B-11 and B-12;

FIG. B-14 is a right side view of the medical device of FIGS. B-11 through B-13;

FIG. B-15 is a front view of the medical device of FIGS. B-11 through B-14;

FIG. B-16 is a rear view of the medical device of FIGS. B-11 through B-15;

FIG. B-17 is a top view of the medical device of FIGS. B-11 through B-16;

FIG. B-18 is a bottom view of the medical device of FIGS. B-11 through B-17;

FIG. B-19 is a perspective view of the medical device of FIGS. B-11 through B-18 including the instrument handle;

FIG. B-20 is a side view of the medical device of FIGS. B-11 through B-19 including the instrument handle;

fig. B-21 are perspective views of a medical device made in accordance with another embodiment;

FIG. B-22 is another perspective view of the medical device of FIG. B-21;

FIG. B-23 is a left side view of the medical device of FIGS. B-21 and B-22;

FIG. B-24 is a right side view of the medical device of FIGS. B-21 through B-23;

FIG. B-25 is a front view of the medical device of FIGS. B-21 through B-24;

FIG. B-26 is a rear view of the medical device of FIGS. B-21 through B-25;

FIG. B-27 is a top view of the medical device of FIGS. B-21 through B-26;

FIG. B-28 is a bottom view of the medical device of FIGS. B-21 through B-27;

FIG. B-29 is a perspective view of the medical device of FIGS. B-21 through B-28 including the instrument handle;

fig. B-30 is a side view of the medical device of fig. B-21 through B-29 including the instrument handle.

Claims (87)

1. An instrument head for attachment to a plurality of instrument handles having different power profiles, the instrument head comprising:

a lighting assembly comprising at least one LED; and

a drive circuit for detecting a power profile of an attached instrument handle and converting a variable voltage received from the attached instrument handle to a constant current to power at least one of the LEDs based on the power profile.

2. The instrument head according to claim 1 wherein the drive circuit outputs Pulse Width Modulation (PWM) of the constant current to illuminate at least one of the LEDs, wherein dimming of at least one of the LEDs is achieved by varying a duty cycle of the PWM of the constant current in response to changes in the variable voltage received from the attached instrument handle.

3. The instrument head of claim 2 wherein the drive circuit outputs the constant current PWM to power the LED at a given illumination level when the drive circuit is connected to a first of the plurality of instrument handles having a first power curve and a first variable voltage or a second of the plurality of instrument handles having a second power curve and a second variable voltage, wherein the first and second power curves are different power curves.

4. The instrument head of claim 1 wherein the drive circuit includes a buck/boost circuit that outputs a constant voltage despite the input voltage from the instrument handle being higher or lower than the constant voltage.

5. The instrument head of claim 1 wherein the drive circuit includes a rectifier including a Field Effect Transistor (FET) for converting alternating current input from the instrument handle to direct current to power the at least one LED.

6. The instrument head of claim 1 wherein the drive circuit comprises a controller, wherein the controller detects a polarity of the instrument handle attached to the instrument head.

7. The instrument head of claim 6 wherein the drive circuit includes a buck/boost circuit that outputs a constant current despite the input voltage from the instrument handle being higher or lower than the constant voltage, and the controller further controls the buck/boost circuit to output a constant current with Pulse Width Modulation (PWM) at a selected duty cycle to illuminate at least one of the LEDs at a particular brightness.

8. The instrument head of claim 6 wherein the controller detects a vibrational or idle state of the instrument head and in response thereto energizes or de-energizes the instrument head.

9. The instrument head of claim 6 wherein the controller uses a look-up table to determine a power curve of the attached instrument handle based on a power-up signal received at the time of attachment.

10. The instrument head of claim 1 wherein the instrument head is part of a physical assessment device.

11. The instrument head of claim 10 wherein the physical assessment device is an otoscope or ophthalmoscope, and wherein at least one instrument handle used with the instrument head is generally configured for use with only incandescent light sources.

12. A physical assessment device comprising:

an instrument head attached to an instrument handle, the instrument head having a distal end and an opposing proximal end;

an illumination assembly disposed within the instrument head and comprising at least one LED;

an optical assembly disposed within the instrument head and comprising a plurality of optical assemblies aligned along an imaging axis; and

an accessory attached to the distal end of the instrument head for inspection purposes, serving as an interface with a patient, wherein the optical assembly produces an entrance pupil that is sufficiently distant from the most distal optical element of the imaging assembly that the attached accessory is not within the field of view of the optical assembly.

13. The body evaluation device of claim 12 wherein the attachment is a speculum tip and the body evaluation device is an otoscope.

14. The physical assessment device of claim 13, wherein the speculum tip is cropped out of the resulting image of the patient's ear canal due to the position of the distal entrance pupil.

15. The physical assessment device of claim 13, wherein the instrument head further comprises a pair of mating housing portions defining an interior of the instrument head, an internal former disposed within the interior and a sealing member attached to the internal former to allow insufflation.

16. The body evaluation device of claim 15 wherein the sealing member is an elastomer and is attached to the proximal end of the inner former, the sealing member further providing an anti-fog measure relative to at least one optical component of the optical assembly.

17. An illumination assembly for a physical assessment device, the illumination assembly comprising:

an LED mounted on the circuit board; and

an assembly that centers and aligns the LED relative to a defined illumination axis, the centering and alignment assembly including a domed surface configured to receive and collimate light from the LED.

18. The lighting assembly of claim 17, wherein the centering and alignment feature comprises an annular ring that centers the domed surface with respect to the LED.

19. The lighting assembly of claim 17, wherein the domed surface is a condenser lens.

20. The lighting assembly of claim 18, wherein the annular ring includes an externally threaded portion that provides a dust and debris barrier for the LED.

21. The illumination assembly of claim 17, wherein the illumination assembly is disposed within the instrument head of the physical assessment device.

22. The lighting assembly of claim 21, wherein the physical assessment device is at least one of an otoscope or an ophthalmoscope.

23. The lighting assembly of claim 21, wherein the instrument head is attachable to an instrument handle housing at least a power source for powering the LED.

24. The lighting assembly of claim 23, wherein the instrument head is attachable to a different instrument handle, including an instrument handle configured to power a lighting assembly having an incandescent lamp as a light source.

25. The lighting assembly of claim 24, wherein said circuit board includes circuitry configured to allow any of a variety of instrument handles to be attached to said instrument head and to power said LED without flashing.

26. A physical assessment device comprising:

an instrument head having a distal end, an opposite proximal end, and an interior;

an optical assembly disposed within the instrument head comprising a plurality of optical components disposed along an optical axis; and

an adapter interface member disposed at a proximal end of the instrument head, the adapter interface member enabling a smart device to be attached to the instrument head and aligned with the optical axis.

27. The physical assessment device of claim 26, further comprising a smart device adapter releasably engaged with the adapter interface member, the smart device adapter having a surface sized and configured to engage a smart device.

28. The body assessment device of claim 27, wherein the adapter interface member comprises a distal portion, a proximal portion, and a recess therebetween.

29. The body evaluation device of claim 26 wherein the adapter interface member retains at least one optical component of the optical assembly.

30. The physical assessment device of claim 28, wherein the smart device adapter comprises a device engagement portion comprising a plurality of engagement surfaces engageable with the recess of the adapter interface member.

31. The physical assessment device of claim 30, wherein the recess of the adapter interface member comprises a plurality of machined planar surfaces engageable with the plurality of engagement surfaces of the smart device adapter.

32. The physical assessment device of claim 31, wherein the smart device adapter comprises a slot having the device engagement portion, the device engagement portion comprising three engagement surfaces, wherein two of the engagement surfaces are arranged in a spaced parallel relationship and a third engagement surface is orthogonal to the two parallel and spaced apart engagement surfaces.

33. The physical assessment device of claim 32, wherein one of the two parallel and spaced apart engagement surfaces is formed on a movable slider member which biases the engagement surface into the slot.

34. The physical assessment device of claim 33, wherein the distal end portion of the adapter interface member comprises a plurality of axial openings, each comprising a ball biased into the recess and configured to engage the smart device when attached.

35. The physical assessment device of claim 32, wherein the machined plane of the recess enables the smart device adapter to be attached in a plurality of orientations about the optical axis.

36. The physical assessment device of claim 31, wherein the smart device adapter further comprises a slot sized and shaped to receive the smart device engagement member.

37. The physical assessment device of claim 36, wherein the smart device engagement member further comprises an adhesive tape on one side, the adhesive tape being attachable to a smart device, and wherein an opposite side of the smart device engagement member comprises a lateral groove.

38. The physical assessment device of claim 37, wherein the smart device adapter comprises a detent member which, when attached through the slot, is engageable with the transverse groove of the smart device engagement member.

39. The physical assessment device of claim 38, wherein the detent member is provided within a detent cap supported within a slot of the smart device adapter, the detent member being biased by a spring supported by the detent cap.

40. The physical assessment device of claim 39, comprising: a strip of insulating material disposed on an inner surface of the supported pawl cover, the strip configured to provide resistance to the smart device engagement member when attached to the smart device adapter via the slot.

41. The physical assessment device of claim 27, wherein the smart device adapter comprises an opening at the device engagement portion that aligns with an optical axis of the optical assembly when attached to the physical assessment device.

42. A smart device adapter for a physical assessment device, the adapter comprising:

an adapter housing comprising a proximal surface sized and shaped to support a smart device; and

a device engagement portion sized and configured to releasably engage a body evaluation device; and

a smart device engagement member having at least one feature releasably attachable to a smart device.

43. The adapter of claim 42, wherein the device engagement portion comprises an arm extending from the adapter housing and configured to engage a lower end of an instrument head of the physical assessment device.

44. The adaptor of claim 43, wherein the arm further comprises an annular engagement portion sized to engage on the lower end of the instrument head, the arm being made of an elastomeric material.

45. The adapter of claim 42, wherein the device engagement portion includes a C-shaped engagement feature at a lower end of the adapter housing sized and shaped to snap-fit with a cylindrical handle of the physical assessment device.

46. The adapter of claim 42, wherein the device engagement portion is configured to engage an adapter interface member at a proximal end of the body assessment device, the adapter comprising a detent member engageable with the smart device engagement member when the smart device engagement member is attached to the adapter housing by a slot.

47. The adapter as in claim 46, wherein the detent member is supported by a detent cover, and wherein the detent member is biased outwardly into the slot by a spring supported by the detent cover.

48. The adapter of claim 46, wherein the smart device engagement member comprises an adhesive tape attachable to a smart device.

49. The adapter of claim 46, wherein the device engagement portion includes a plurality of engagement surfaces spaced and shaped to engage the adapter interface member of the body assessment device.

50. The adapter of claim 49, wherein one of the plurality of engagement surfaces of the device engagement portion is biased toward another of the engagement surfaces.

51. The adapter of claim 50, wherein the biased engagement surface is an edge surface of a slide member that is movably biased toward the other of the engagement surfaces by a compression spring.

52. The adapter of claim 46, comprising a through hole disposed relative to the device interface that aligns optics of an attached smart device with an optical axis of the body assessment device.

53. A smart device adapter for a physical assessment device, comprising:

a pair of housing portions defining an interior;

a device engagement portion sized and configured to releasably engage a proximal end of the body evaluation device; and

a smart device engagement member configured to releasably engage the slot of one of the housing portions and having at least one feature that enables releasable attachment to a smart device.

54. The adapter of claim 53, wherein one of the housing portions includes a slot sized and configured to receive the smart device engagement member.

55. The adapter of claim 54, comprising a detent member extending through the slot and engageable with the smart device engagement member.

56. The adapter of claim 55, comprising at least one feature that biases the pawl member relative to the slot to engage with the smart device engagement member.

57. The adapter of claim 56, wherein the smart device engagement member includes an adhesive strip on one side engageable with a smart device and a transverse groove on an opposite side engageable with the detent member when the smart device engagement member is attached to the slot of the adapter.

58. The adapter of claim 56, wherein the detent member is supported within a detent cap within an interior of the adapter housing, the detent member being spring biased outwardly into the slot.

59. The adapter of claim 53, wherein the device engagement portion includes a plurality of engagement surfaces formed in a slot-like configuration that enable releasable attachment to an adapter interface member of a physical assessment device.

60. The adapter of claim 59, wherein one of the engagement surfaces is inwardly offset relative to the slot configuration of the device engagement portion.

61. The adapter of claim 60, in which the biased engagement surface is an edge surface of a slide member, the position of the slide member relative to the slot arrangement being spring biased.

62. The adapter of claim 53, comprising a through-hole formed in the adapter housing, the through-hole aligned with an optic of an attached smart device.

63. An ophthalmic apparatus, comprising:

an instrument head comprising a distal end and an opposing proximal end;

an illumination assembly disposed within the instrument head including at least one light source for illuminating a medical target of interest; and

a pair of fixation lights disposed in spaced relation at a distal end of the instrument head.

64. The ophthalmic apparatus of claim 63, comprising a plurality of optical fibers extending from the at least one light source to the fixation lamp.

65. The ophthalmic apparatus of claim 63, further comprising an optical assembly including an objective lens disposed at a distal end of the instrument head, the fixation lamp disposed distally relative to the objective lens.

66. The ophthalmic apparatus of claim 63, wherein the at least one light source is an LED.

67. The ophthalmic apparatus of claim 63, wherein the fixation lamp comprises a polarizer window.

68. The ophthalmic apparatus of claim 63, further comprising an elastic eyecup releasably attached to the distal end of the instrument head.

69. An instrument handle for a physical assessment device comprising an instrument head attached to an upper end of the handle, the instrument head having an illumination assembly with at least one housed light source:

the handle includes:

at least one rechargeable battery for powering the at least one light source;

a charging port disposed at a bottom end of the handle; and

a USB power boost port.

70. The instrument handle of claim 69, further comprising a set of electrical contacts that enable a dual charging mode.

71. The instrument handle of claim 70, wherein the instrument handle is configured to operate in a first USB charging mode and a second charging mode using a charging cradle.

72. The instrument handle of claim 71, wherein the electrical contacts are provided at the bottom of the handle to allow the at least one rechargeable battery to perform the second charging mode according to one mode, and wherein the USB power boost port is chargeable in the first USB charging mode.

73. The instrument handle of claim 69, further comprising a circuit extending to the at least one rechargeable battery, the circuit configured to determine an over-temperature condition.

74. The instrument handle of claim 73, wherein an output of the circuit is directed to the charging cradle to detect overheating of the at least one housed battery during charging and discharging events.

75. A charging stand equipped to hold one or more body assessment devices that house at least one rechargeable battery for charging, the charging stand comprising: at least one charging well having contacts configured to engage corresponding contacts of a handle of at least one body assessment device, the cradle having a plurality of indicators for indicating a charging status of a held device.

76. The charging stand of claim 75, wherein at least one body assessment device held by the charging stand comprises a smart device attached to a proximal end of the instrument.

77. The charging stand of claim 76, wherein the charging stand is configured to hold a plurality of physical assessment devices with attached smart devices without interference.

78. The charging stand of claim 76, wherein the smart device is a smartphone.

79. A body assessment device holding at least one battery to power a housed illumination source, the device comprising a rheostat to adjust the illumination level of the housed light source, wherein the rheostat comprises a twistable grip portion on an instrument handle, the grip portion enabling adjustment of the position of the rheostat and wherein the twistable grip portion is provided with a series of detent stops to provide audible and tactile feedback regarding the position of the rheostat.

80. The body assessment device of claim 79, wherein the detent position of the rheostat creates a preferred arrangement that can be reused to obtain a consistent amount of light per use.

81. A physical assessment device comprising:

an instrument head having a distal end, an opposite proximal end, and an interior;

an illumination assembly disposed within the instrument head and including at least one light source and a plurality of components aligned along a defined illumination axis;

wherein at least one of the light sources is disposed within a lower end of the instrument head, the apparatus further comprising:

a reflector to direct light from the at least one light source, an

At least one feature for adjusting the mirror.

82. The physical assessment device of claim 81, further comprising:

a mirror support base for holding the mirror; and

an adjustment member accessible through the housing of the instrument head during manufacture, the adjustment member engaging the mirror support to adjust the position of the mirror relative to the illumination axis.

83. The physical assessment device of claim 82, wherein the mirror support base enables the held mirror to pivot.

84. The physical assessment device of claim 83, wherein the adjustment member enables lateral and pivotal movement of the retained mirror.

85. The physical assessment device of claim 84, wherein the mirror support base is supported within a housing, the housing having an opening to allow the adjustment member to access the first surface of the mirror support base.

86. The body assessment device of claim 85, wherein the adjustment member engages the first surface of the mirror support mount to effect pivotal movement of the retained mirror, and wherein an elastic material is provided relative to a second surface of the mirror support mount, the second surface being opposite the first surface, to provide a resistance force.

87. The physical assessment device of claim 86, wherein the housing is provided within a base member, the housing having a sealing member which generates a frictional load to maintain lateral adjustment of the retained mirror by the adjustment member.

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