System, method, and apparatus for massaging eyelids

Abstract

To suppress invasiveness and improve comfort for the patient. 【Solution means】 The device massages the eyelid to move the meibomian gland in one direction through the meibomian gland duct towards the gland duct orifice at the eyelid margin in order to remove the meibomian gland duct blockage within the gland duct. The device is configured to periodically apply pressure to the application area of the eyelid, move the applied pressure in the flow direction towards the gland duct orifice, and release the pressure applied to the application area of the eyelid. This device includes an elongated massage arm configured to support a massage tip configured to apply pressure to the application area of the eyelid. The cam is rotatable about a rotation axis and includes a cam surface. The follower includes a follower surface that slidably engages with the cam surface. The follower is configured to impart a massage motion to the massage arm in response to the rotation of the cam. The cam surface has a curved configuration of a constant width. The cam is configured such that the center of the cam surface is offset from the rotation axis of the cam.

Description

Technical Field

[0001] The present disclosure relates to systems, methods, and apparatuses for massaging eyelids.

Background Art

[0002] The ocular surface of the eye is generally coated with a three-layered film called the tear film or tears. As shown in FIGS. 1 and 2, the three layers of the tear film are the mucin layer that adheres to the ocular surface (epithelium), the middle aqueous layer, and the upper / lateral lipid meibomian layer. The mucin layer and the aqueous layer are produced by the lacrimal gland and other glands within the conjunctiva of the eye. The meibomian layer is produced by the meibomian glands within the eyelids. Tears flow from the ocular surface through the nasolacrimal duct, which drains into the back of the nose and throat.

[0003] The mucin layer of the tear film is hydrophilic, which helps to spread the aqueous layer evenly over the ocular surface. Together, the mucin layer and the aqueous layer help to maintain lubrication across the ocular surface and reduce shear stress during blinking or friction. The meibomian forms the outermost layer of the tear film. Since it is mainly lipid in composition, the meibomian layer has a lower surface tension and forms an outer film that reduces the rate of aqueous evaporation. This keeps the aqueous layer more uniform and free of dry spots, thereby lubricating the ocular surface for a longer period without the need for refreshment. The tear film is antibacterial and helps to maintain the health of the eye and remove any contaminants or particles that may come into contact with the eye.

[0004] Dry eye disease, i.e., DED, affects millions of people worldwide. According to some studies, the third most common reason for visiting an ophthalmologist's clinic is due to the symptoms of dry eye disease. Recently, it has been shown that up to 80% of dry eye cases also have an element called meibomian gland dysfunction or MGD. Normally, the lipid layer produced by the meibomian glands spreads evenly over a thin (about 200 nm thick) protective film that covers the air-tear interface on the cornea.

[0005] Each time the eye blinks, a small amount of meibomian lipid protective film spreads. However, there are many conditions where sufficient meibomian does not spread across the aqueous tear film. The root causes include hormonal changes in meibomian gland oil production that affect properties such as viscosity, glands covered by the eyelid margin, skin mites that live on the eyelashes, long-term infections such as chalazia that are difficult to remove, general inflammation (blepharitis), autoimmune diseases or allergic reactions, and more recently, inappropriate blinking from excessive screen time known as computer vision syndrome (CVS), but are not limited to these.

[0006] In the absence of an appropriate outer protective lipid layer, the evaporation time of the tear film covering the eye is shortened, and dry patches may occur on the corneal epithelium. This is quantitatively measured as a so-called tear film break-up time measurement criterion abbreviated as TBUT or TFBUT.

[0007] In the past, mild MGD has been addressed by warm compresses, using eyelid cleansing compounds, and gently massaging the eyelids. However, these approaches have not been shown to be clinically effective in most cases of severe dry eye.

[0008] More recent treatments involve heating the meibomian glands from the inside of the eyelid to melt or soften the clogged oil. When the eyelid is heated from the inside, heat is delivered directly to the meibomian glands. In some examples, an air bag is also used to massage the meibomian glands to help squeeze out the softened oil blockage from the meibomian glands. However, such procedures can still be highly invasive and expensive procedures that require a specialist ophthalmologist and multiple treatments per year. Other known eye treatments include using a heating pad to heat the outside of the eyelid. In this type of procedure, the ophthalmologist still has to use forceps with intermediate pressure to effectively squeeze the glands. Such treatments can also be invasive and uncomfortable for the patient. SUMMARY OF THE INVENTION

[0009] The system, method, and apparatus are configured to treat MGD by massaging the eyelid or eyelids to move the meibomian in one direction through the meibomian gland towards the meibomian gland orifice at the eyelid margin. The system, method, and apparatus can further be configured to heat the meibomian gland while massaging the eyelid. The system, method, and apparatus implement an eye shield that at least partially covers the eyeball to protect the eye and assist in fixing the position of the apparatus relative to the eye. A retractable massage arm engages the eyelid and has a soft massage tip that applies a massage motion to squeeze the meibomian from the meibomian gland through the gland orifice.

[0010] Through the motion imparted by the massage arm, the massage tip applies a massage treatment in a rectangular motion according to the following series of motions, which are repeated throughout the treatment session. ● The massage tip moves linearly towards the eyelid and engages the eyelid surface under pressure. ● The massage tip pivots downward (when massaging the upper eyelid) or upward (when massaging the lower eyelid) to squeeze the meibomian from the meibomian gland towards the outlet gland orifice. ● The massage tip disengages from the engagement with the eyelid and moves linearly away from the eye (i.e., retracts). ● While disengaged, the massage tip pivots upward (for the upper eyelid) or downward (for the lower eyelid) to return to the starting position.

[0011] The movement of the massage tip is provided by a massage arm through a cam / follower mechanism configured to convert the rotational movement imparted by the drive system into a series of movements of the massage arm outlined above. The cam has a rounded polygonal configuration with a cam surface that forms a constant-width curve similar to the triangle of a roulette. The follower has a square configuration with a square follower surface having a width approximately equal to the width of the constant curve of the cam. Thus, the cam fits within the follower and can rotate within the follower, and the cam surface maintains a constant engagement with the follower surface. The axis of rotation of the cam is offset from its center so as to produce an eccentric movement during rotation. Through this eccentric movement, in combination with the respective configurations of the cam and the follower, the movement of the massage tip is generated.

[0012] According to one aspect, the device massages the eyelid to move the meibomian gland in one direction through the meibomian gland duct towards the gland duct orifice at the eyelid margin in order to remove a blockage of the meibomian gland in the gland duct. The device is configured to periodically apply pressure to an application area of the eyelid, move the applied pressure in the flow direction towards the gland duct orifice, and release the pressure applied to the application area of the eyelid. The device includes an elongated massage arm configured to support a massage tip configured to apply pressure to an application area of the eyelid. The cam is rotatable about a rotation axis and includes a cam surface. The follower includes a follower surface that slidably engages the cam surface. The follower is configured to impart a massage movement to the massage arm in response to rotation of the cam. The cam surface has a constant-width curve configuration. The cam is configured such that the center of the cam surface is offset from the rotation axis of the cam.

[0013] According to another aspect, the cam and the follower can be configured such that the massage movement follows a rectangular path.

[0014] According to another aspect, the rectangular path is axially directed towards the eyelid to engage with the application area, linearly follows the eyelid in the flow direction of the meibomian gland duct while engaged with the application area, axially departs from the eyelid to disengage from the application area, and can be continuously configured to be linear in a direction opposite to the flow direction in a state of being disengaged from the application area.

[0015] According to another aspect, the cam and the follower are such that the massaging movement of the massage ● includes a first movement that moves from the initial position to engage with the application area of the eyelid and applies pressure to the application area of the eyelid, ● includes a second movement that moves in the flow direction towards the gland duct orifice while applying pressure to the application area, ● includes a third movement that moves away from the eyelid to disengage from the eyelid, ● and includes a fourth movement that returns to the initial position, and can be configured to include such movements.

[0016] According to another aspect, the surface of the follower may be the surface of the massage arm.

[0017] According to another aspect, the follower can include an opening within the massage arm, and the cam can be positioned within the opening. The opening can have a width larger than the width of a constant-width curve on the cam surface. The width of the opening can be configured to allow the cam to rotate within the opening while engaging with the surface of the follower.

[0018] According to another aspect, the opening can generally have a square shape.

[0019] According to another aspect, the cam can be configured such that the cam surface is always maintained in contact with all four sides of the square opening of the follower.

[0020] According to another aspect, the device can also include a pin / slot mechanism that supports the massage arm on the housing. The pin / slot mechanism can include a fixed pin supported on the housing and a slot on the massage arm through which the pin extends. The massage arm can be configured to pivot about the fixed pin and slide along the length of the slot on the fixed pin.

[0021] According to another aspect, the cam and the follower can be configured such that the rotational movement of the cam generates a rectilinear movement of the massage tip.

[0022] According to another aspect, the device can also include at least one infrared light source configured to heat the meibomian glands within the eyelid meibomian gland ducts through the massage tip, either independently of the massage movement of the massage tip or simultaneously with the movement of the massage tip.

[0023] According to another aspect, the infrared light can be emitted at a wavelength of about 900 nm to 1100 nm, preferably about 985 nm to 1015 nm.

[0024] According to another aspect, the device can also include an eye shield configured to engage and cover at least a portion of the eye and disposed between the eye and the eyelid to shield the eye from the infrared light.

[0025] According to another aspect, the eye shield can also include at least one temperature sensor configured to sense the temperature in the area of the eye and eyelid exposed to the infrared light.

[0026] According to another aspect, the eye shield can include a translucent portion through which visible light can pass. The translucent portion can be configured to enable a camera to image the eyelid during treatment.

[0027] According to another aspect, the massage tip can be configured to pass infrared radiation and apply heat to the eyelid.

[0028] According to another aspect, the device can also include a latch arm having a latch tip, wherein the latch tip is configured to move toward each other to a latched state that latches the tab portion of the eye shield to fix the eye shield to the device and restrict movement of the eye shield relative to the massage arm.

[0029] According to another aspect, the device can also include a treatment arm that is operable from a retracted position to a treatment position. The treatment arm can be configured to move the latch arm to a latched state when in the treatment position. The treatment arm can also be configured to move the latch arm to a released state when in the retracted position. The treatment arm also includes a spring member configured to bias the treatment arm to the retracted state when released so that quick release of the eye shield tab portion is automatically achieved.

[0030] According to another aspect, the treatment lever can also be configured to control the operation of a front positioning carriage that carries the massage arm. The treatment lever can be configured to linearly move the front positioning carriage to position the massage arm between a retracted state when no massage motion is applied and an extended position for applying a massage motion to the eyelid.

[0031] According to another aspect, the device can also include an LED array arranged to provide light for optical heating. The LED array can be configured to adjust its brightness to provide high-contrast imaging light for video imaging of the meibomian glands during a short period of heating.

[0032] According to another aspect, the LED heating array can be supported on a PCBA connected to a heat sink. The PCBA can also support the attachment of a micro camera.

[0033] According to another aspect, the eye shield can also include a transparent portion including one or more embedded mirror surfaces. The mirror surfaces can be configured to redirect the main converging light rays of the micro camera towards the upper eyelid margin and the lower eyelid margin, enabling the micro camera to view the eyelid and the meibomian gland duct orifice laterally.

[0034] According to another aspect, the device can also include a fan and a heat sink for cooling the LED array.

[0035] According to another aspect, the device can also include a magnetic sensor electronically coupled to a kill switch for turning off the LED array in response to the release of the treatment arm. The magnetic sensor can activate the kill switch by sensing the proximity of one or more magnets attached to the treatment arm.

[0036] According to another aspect, the periodically applied pressure can be configured to be 8 psi or less.

Brief Description of the Drawings

[0037] The present invention is shown by way of example and not limitation in the accompanying drawings.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10A

Figure 10B

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

DETAILED DESCRIPTION OF THE INVENTION

[0038] The system, method, and apparatus are configured to treat MGD by massaging one or both eyelids so as to move the meibomian glands in one direction through the meibomian glands towards the meibomian gland orifices at the eyelid margins. The system, method, and apparatus can further be configured to heat the meibomian glands while massaging the eyelids. An exemplary configuration of the MGD treatment system 10 including the MGD treatment device 20, which is configured to implement a method for treating MGD, is illustrated in FIGS. 3 - 25.

[0039] The device 20 includes a housing 22 that supports the components described herein. The battery pack 24 supplies power for operating the device 20. For example, as shown in FIGS. 4, 5, 6 - 8, and 11, the treatment lever 30 is operable to activate the device from a retracted state (FIGS. 4, 6, 7) to an extended state (FIGS. 5, 8, 11). The retracted and extended states of the device 20 refer to the state of the massage arm 50 (FIG. 6) to which a massage movement is applied to the eyelids via the massage tip 70 attached to the end of the massage arm. In the configuration shown in the figures, the device 20 includes upper and lower massage arms and can massage the upper and lower eyelids of a subject suffering from MGD through these associated massage tips 70 (see FIG. 16). As shown, the device 20 can be in a compact form to facilitate ease of use. The device 20 may not be larger than, for example, a handheld camcorder of a similar shape used by videographers and may be lightweight.

[0040] The device 20 also includes an eye shield 80 that serves several purposes. First, the eye shield 80 shields the interior of the eye, including the retina and cornea, from infrared (IR) light applied via an array of light-emitting diodes (LEDs), herein referred to as the LED array 100. The LED array 100 is attached to a printed circuit board assembly (PCBA) 101 incorporated into the device 20. The LED array 100 is configured to heat the eyelid to soften and / or relax clogged meibomian glands and improve meibomian flow. Excessive heat reaching the eye cup 82 disposed on the inner side of the eyelid is reflected towards the meibomian glands. Second, the eye shield 80 helps to adjust the relative position of the device 20 with respect to the eye / eyelid and maintain that relative position throughout the treatment session. Finally, the eye shield 80 prevents the squeezing pressure during the milking operation on the eyelid from being transmitted to the eyeball inside the eye socket.

[0041] The eye shield 80 is easily attachable / detachable to / from the device 20, which allows it to be applied to the eye while the eye shield 80 is removed. With the eye shield 80 in place over the eye, the eye shield 80 can be connected to the device 20 via a quick-release mechanism described in detail below. When the eye shield 80 is installed, the device 20 is positioned in the extended position via the treatment lever 30 for treatment.

[0042] The eye shield 80 is shown in detail in FIGS. 10A and 10B. As shown, the eye shield 80 includes a scleral-shaped eye cup 82 configured to be positioned slightly above the surface of the cornea in a manner similar or identical to a hard contact lens (FIG. 16). The shape of the eye cup 82 may be spherical or parabolic and may include a flare 84 at the temple or nasal edge to enhance coverage and protection. The eye cup 82 is composed of a biocompatible material that reflects IR light to protect the eye. The eye cup 82 can be composed of, for example, poly(methyl methacrylate) or "PMMA" material.

[0043] The I-Shield 80 also includes an integrated structure in the form of a tab 86 that supports the eye cup 82 and makes it much easier to place in or remove from the eye. The I-Shield tab 86 is configured to be latched by a quick release mechanism 98 that includes a latch arm 90 having a latch tip 108 configured to capture the I-Shield 80 by latching around the angled edge of the I-Shield tab 86. The latch arm 90 is supported on a forward positioning carriage 92 within the housing 22, and the latch arm 90 is connected to the forward positioning carriage 92. Specifically, the end 106 (see FIG. 12) of the latch arm opposite the capture tip 108 is pivotally connected to the forward positioning carriage 92. Between the end 106 and the latch tip 108, the latch arm 90 includes a slot 94 that receives a fixed pin (not shown), whereby the latch arm can slide along the pin and pivot with respect to the pin.

[0044] Forward movement of the forward positioning carriage 92 moves the latch tips 108 forward and out of the housing 22 and towards each other simultaneously. Conversely, rearward movement of the forward positioning carriage 92 moves the latch tips 108 away from each other simultaneously and retracts them into the housing 22. The quick release mechanism 98 is configured to be actuated through the actuation of a treatment lever 30 that causes the forward / backward sliding movement of the forward positioning carriage 92.

[0045] In the forward lock position of the treatment lever 30, generally indicated by arrow F in FIG. 6, the quick release latch arm 90 captures the shield tab 86 of the shield along the angled edge outside the shield tab 86. In the rear release position of the treatment lever 30, generally indicated by arrow R in FIG. 6, the quick release mechanism latch arm 90 slides rearward along 92 and thus opens along the edge of the shield tab 86, releasing the eye cup 80 from the hand-held treatment device 20. The torsion spring 99 biases the treatment lever 30 toward the retracted position, such that quick release of the shield 80 occurs automatically and rapidly in response to release of the treatment lever 30.

[0046] To facilitate the capture function of the shield and ensure quick release of the eye cup 80, the tip 108 of the latch arm 90 has interfacing surfaces with keyed surfaces 96 (see FIG. 12) that reach over the outer edge of the shield tab 86 and interlock with each other. Further, a horizontal receiving slot 95 (see FIG. 3) vertically constrains the shield tab 86 when the tip 108 of the latch arm 90 is interlocked. Conversely, quick release of the eye cup 80 is achieved by pulling the latch arm 90 away when the treatment lever 30 is placed in the rear position. Thus, as soon as the treatment lever 30 moves rearward toward the release position, the resulting movement of the keyed surfaces 96 away from each other causes immediate release of the shield tab 86. As described above, the torsion spring 99 ensures that the treatment lever 30 moves rearward as soon as it is released by the user.

[0047] When the latch arm 90 is in the position shown in FIG. 12, the eye shield tab 86 is captured by the latch arm as shown in FIG. 26. In this state, the inclined surface 83 of the eye shield tab 86 is constrained by a complementary surface 85 on the tip 108 of the latch arm 90. The trailing edge 87 of the eye shield tab 86 is constrained by a complementary surface 89 on the housing 22. As described above, the up and down movement of the eye shield tab 86 is constrained by complementary surfaces of the housing 22 that define the slot 95 (see FIG. 3). "Constrained" means that it represents the fact that the connection of the eye shield tab 86 to the device 20 is not rigid. Instead, the tab 86 is constrained such that some degree of freedom of movement of the eye shield 80 relative to the rest of the device 20 is allowed. This freedom of movement accounts for the slight movement of the device 20 when held by a physician during use.

[0048] When supported on the massage device 20, the eye cup 82 is provided facing forward as shown in the figure. The eye shield tab 86 can also include an internal thin near-field communication radio frequency identification (NFC RFID) flex circuit that can wirelessly authenticate the eye shield and communicate the temperatures of temperature sensors embedded in the top and bottom of the eye cup during treatment. The wireless technology is similar to that used for wireless credit card payment transactions. The eye shield tab 86 can be composed of a medical grade plastic overcoating for biocompatibility. Finally, an optional transparent insert 88 can be provided to enable real-time visualization of the eyelid margin and meibomian gland expression during treatment via an integrated IR microcamera mounted on the PCBA 101.

[0049] The eye shield tab 86 is captured by an outer latch arm so as to be supported with respect to an internal massage support structure known as the housing 22 and the massage carriage 170. The device 20 includes two massage carriages 170, one associated with each of the massage arms 50 (upper and lower). In this way, the massage arms 50 and the massage tips 70 move with respect to both the housing 22 and the eye shield 80 and are finely adjusted as described herein to compress the eye shield and the eyelid with the required pressure without compressing the eye socket.

[0050] As shown in the figure, the eye shield 80 is positioned at the front end of the massage device 20 with which the subject's eye is engaged to position the massage tip 70 in an appropriate relative position during use of the device 20. When the eye shield 80 is attached to the patient's eye, the handheld unit is operated to position the quick release mechanism 98 on the eye shield tab 86. The treatment lever 30 is then operated to capture the eye shield tab 86 within the quick release mechanism 98 and move the massage arm 50 forward to the extended position, whereby the massage tip 70 can perform a massage motion on the eyelid when the device 20 is operated.

[0051] In the upper part of the housing 22, the IR heating control unit 110 enables the physician using the device to control the heat setting for the IR heat applied via the LED array 100 and the cooling provided by the cooling fan 102. Both the LED array 100 and the cooling fan 102 are supported between the upper and lower pairs of the massage arms 50 by the upper and lower pairs of the massage arms 50. Excessive resistive heat is transferred from the back side of the PCBA 101 to the fan 102 via a metal heat spreader connected to the fins 103 (FIG. 13). As shown in FIG. 20, at the rear of the housing 22, the power / massage control unit 112 enables the ophthalmologist to turn on the power of the device and can optionally have up and down arrows for adjusting setting parameters such as pressure, temperature, or treatment time before starting the treatment.

[0052] Using a rear mount display 114 with a size of about 1 inch or more, several measurement criteria such as the time remaining for treatment, battery level, which eye and eyelid are being treated, and the current eyelid treatment temperature can be shown. In addition, the wireless video connection can be used to project a large display of MGD treatment during the process using an internal micro camera 104 (see FIG. 16) such as a wafer scale micro camera from OmniVision Technologies, Inc. or others. In one example, the camera 104 can be mounted on the same PCBA 101 as the LED array 100 (see, for example, FIGS. 17-19).

[0053] The massage carriage 170 and arm 50 support several components that facilitate the application of heat and massage movement while monitoring the progress of treatment via a video screen. The LED array 100 and their associated cooling fans 102 are attached to the rear of the massage tip 70. These tips 70 are constructed from materials such as silicone or polyurethane that allow IR energy to pass through their structure and heat the eyelid. Thus, the IR energy can be applied directly to the eyelid at the exact location where the massage treatment is applied. In fact, the massage tip 70 can be configured to direct and / or focus the IR energy to a specific portion of the eyelid, whereby the blockage of the meibomian glands and gland orifices can be heated both before and during the massage treatment. The LED array 100 may be stationary relative to the massage arm 50, but the movement of the massage arm / massage tip is small enough that the light from the LED array is sent through the massage tip.

[0054] The micro camera 104 of the massage carriage 170 can be directly attached to the PCBA 101 and thus does not move with the massage arm / tip. In one exemplary configuration, the camera 104 can be directed towards an angled mirror 87 inside the optical insert 88 that directly captures scattered IR light returning from the eyelid margin back to the micro camera 104 by imaging through the transparent insert 88. The main central ray 74 is shown in dotted lines in FIG. 16 for each camera. This allows the physician to view the progress of the treatment in real time via a screen attached at the rear or, more conveniently, via a large external display. Alternatively, the micro camera 104 could potentially be attached somewhere else at a different location in order to directly focus on the eyelid.

[0055] The massage device 20 includes a sliding massage carriage 170 that holds the massage arm 50, and the massage arm 50 can be driven by a motor 160 and a gear 162 to perform a "milking motion" relative to the position of the ridge carriage 170. There are two massage carriages 170, one associated with each pair of massage arms 50, that is, one is associated with the upper massage arm and one is associated with the lower massage arm. The massage carriage 170 is fixed to the massage arm 50. The massage carriage 170 can slide forward or backward, that is, towards or away from the eye shield, using a sliding foot 171 that slides inside a guide rail 172 in the housing (FIG. 21). As best shown in FIGS. 13 and 19, each massage carriage 170 supports drive train components including a motor 160 for generating a rotational motion, a reduction gear mechanism 162, and a gear mechanism 164 such as a miter gear for translating the rotational axes of the motor and the reduction gear mechanism along different axial directions. The drive train components and the way the drive train components impart rotational movement to the massage device 20 are not particularly important, and alternative mechanisms, components, etc. can be implemented. Additionally, instead of individual sets of drive train components for each pair of massage arms 50, the device 20 can include a single set of drive train components configured to impart movement to both the upper and lower pairs of massage arms.

[0056] Each pair (upper and lower) of the massage arms 50 supports the massage tip 70. The massage tip 70 is configured to include a soft portion or pad 72 that physically engages the eyelid, at least in part. The massage tip 70 can be formed from a soft IR-permeable material such as silicone rubber that is flexible and suitable for direct engagement with the eyelid skin / tissue. The massage tip 70 can be formed from a single piece of homogeneous material such that the pad 72 is integral with the massage tip. Alternatively, the pad 72 can be composed of a material such as silicone rubber and can be attached to a more rigid material at a base 71 that can be fixed to the massage arm 50 via a pin connection (see FIGS. 18-19). The massage pad 72 can have a shape on the eyelid contact side 72 configured to mimic and conform to the typical anatomical structure of an average eyelid and can be flexible enough to conform to any shape.

[0057] The movement imparted to the massage arm 50 by the drive train 170 is described with reference to FIG. 14, which is a schematic view of the massage arm. The massage arm 50 extends along a longitudinal axis referred to herein as Axis A T for the reason that this is the axis along which the translational movement of the massage arm occurs, as generally indicated by the arrow labeled L in FIG. 14. The massage arm 50 is supported by a pin / slot mechanism formed by a fixed pin 54 and an elongated slot 52 within the massage arm through which the pin extends. The pin 54 defines a pivot axis A P and the massage arm 50 can pivot or rotate about this pivot axis, as generally indicated by the arrow labeled P in FIG. 14. The slot 52 is configured to extend along the length of the massage arm 50, i.e., along Axis A T . Thus, the movement of the massage arm 50 imparted by the drive train 170 can be a linear movement L along Axis A T , a pivoting movement about pivot axis A P , or a combination of linear and pivoting movements.

[0058] The massage device 20 also includes a cam / follower mechanism 150 configured to convert the rotational motion provided by the drive train 170 into linear and pivotal movement of the massage arm 50. The cam / follower mechanism 150 is schematically shown in FIG. 14. As shown in FIG. 14, the massage arm 50 linearly slides back and forth along a linear axis A, generally indicated by arrow L, via a pin / slot slider mechanism, and pivots about a pivot axis A, generally indicated by arrow P, via a pin / slot slider mechanism. The cam / follower mechanism 150 includes a cam 152 disposed within a follower 154. As shown in FIG. 14, the follower 154 may be an opening extending within / through the massage arm 50. T along the linear axis A via a pin / slot slider mechanism, and pivots about a pivot axis A P via a pin / slot slider mechanism, as generally indicated by arrow P. The cam / follower mechanism 150 includes a cam 152 disposed within a follower 154. As shown in FIG. 14, the follower 154 may be an opening extending within / through the massage arm 50.

[0059] The cam 152 has a rounded polygonal configuration with a cam surface 156 forming a constant-width curve similar to a roulette triangle. The follower 154 has a square configuration with a square follower surface 158 having a width approximately equal to the width of the constant curve of the cam 152. Thus, the cam 152 fits within the follower 154 and can rotate within the follower, and the cam surface 156 maintains a constant engagement with the follower surface 158. The materials used to construct the cam 152 and the follower 154 can be selected to facilitate sliding engagement between the cam surface 156 and the follower surface 158 with minimal friction and minimal wear. The cam / follower materials can be, for example, the plastic Delrin® acetal homopolymer (polyoxymethylene POM) commercially available from Dupont de Nemours, Inc., or a similar material with natural dry lubrication. Lubricants such as grease can also be used additionally.

[0060] The cam 152 is rotatable about a rotation axis A, as generally indicated by the arrow labeled R in FIG. 14. The rotation axis A of the cam 152 R is rotatable about the rotation axis A of the cam 152 RIt is offset from its center so as to cause eccentric motion during rotation. Since the cam surface 156 is configured to maintain engagement with all four sides of the follower surface 158, the cam 152 acts as a positive motion cam. The eccentric rotational motion of the cam 152 imparts motion to the massage arm 50, and the motion can be linear motion (arrow L), pivotal motion (arrow P), or a combination of linear motion and pivotal motion.

[0061] The motion of the massage arm 50 generated by the cam / follower mechanism 150 is configured to generate a desired massage motion at the massage tip 70 of the massage arm 50. Advantageously, the massage motion is in the shape of a rectangle. The characteristics of the massage motion can be controlled individually or in combination through the configuration / adjustment of the following parameters. ● The size and / or constant curve shape / width of the cam 152. ● The offset distance between the center of the cam and the rotation center A R ● The distance of the pin / slot slider mechanisms 52, 54 from the rotation center A R ● The length of the massage arm 50.

[0062] By configuring / adjusting these parameters, a wide variety of rectangular shapes for the path of the massage tip can be achieved.

[0063] In an exemplary configuration, the massage assembly can be configured to generate a rectangular path at the massage tip with a linear back-and-forth movement of 1 mm towards and away from the eyelid, and a pivotal up-and-down squeezing motion between 1 mm and 2 mm. This operation generates a rectangular motion of the massage pad that engages the eyelid to massage the eyelid to treat MGD. This movement is shown in FIG. 15, which shows a series of views showing the state of the massage device at various rotational angles of the cam 152. In these views, the cam 152 rotates clockwise. The linear left / right movement is shown as a negative value for left / down and a positive value for right / up.​​

[0064] From the 0° position, the cam rotates counterclockwise as indicated by the line indicator on cam 152 passing through the positions shown in the table. Axis of rotation A R Due to the offset of R axis of rotation A, the portion of the cam surface 156 on the side opposite to it, surface S, imparts motion to the massage arm. Since the cam surface S is circular, the movement imparted by the cam surface S is constant through engagement with any one of the four sides of the follower surface 158. This generates distinct linear / pivoting movements of the massage arm 50 over a specific angular range of cam rotation shown in FIG. 15, which are translated into corresponding distinct movements of the massage tip 70.

[0065] In the example of FIG. 15, the movement of the pivoting tip is defined as 2.0 mm by the configuration of the massage assembly, with +1.0 mm being the upper position and -1.0 mm being the lower position. The linear movement of the tip is defined as 1.0 mm by the configuration of the massage assembly, with +0.5 mm being the left position of the tip and -0.5 mm being the right position of the tip.

[0066] As shown in FIG. 15, at the 0° cam position, the massage tip is linearly at the central 0 mm position and the tip is pivoted 1.0 mm above. As the cam rotates to the 45° position (clockwise in this example), the tip moves to the left -0.5 mm position and is maintained in the upper position. As the cam rotates to the 90° position, the tip is maintained in the left position and moves to the -1.0 mm lower position. As the cam rotates to the 135° position, the tip is maintained in the left and lower positions. As the cam rotates to the 180° position, the tip moves to the central position and is maintained in the lower position. As the cam rotates to the 225° position, the tip moves to the +0.5 right position and is maintained in the lower position. As the cam rotates to the 270° position, the tip is maintained in the right position and moves to the upper position. As the cam rotates to the 315° position, the tip is maintained in the right and upper positions. Next, the cycle is repeated at the 0° position.

[0067] In practice, the movement of the massage arm 50 described above is advantageous for treating a subject having MGD. This is schematically shown in FIG. 16, which is an enlarged view of a massage device arranged for treating a subject having MGD. As shown, the massage device 20 is positioned against the eye with the eye shield 80 positioned over the eyeball. In this state, the eye shield 80 serves the dual purpose of controlling the position of the massage arm with respect to the eye and the eyelid, while at the same time shielding the eye from IR radiation emitted from the LED array 100. For added safety, the eye shield can include a temperature sensor configured to control the LED array 100 to maintain a desired temperature or turn off the LED array if the temperature gets too high.

[0068] The relative position of the eye shield with respect to the massage arm can be finely adjusted so that a desired amount of pressure is applied to the eyelid during the massage session. For example, it may be desirable to massage the eyelid with a pressure of 2 psi. For this purpose, the device 20 can be configured to finely adjust the position of the massage arm 50 with respect to the eye shield 80, which in practice controls the position of the massage tip 70 with respect to the patient's eyelid. This is important because the distance of the massage tip 70 from the eye shield 80 required to apply the desired pressure varies between patients due to differences in anatomical structure from patient to patient. This fine adjustment helps to accurately control the pressure applied to the patient's eyelid via the massage tip 70 by the massage arm 50.

[0069] The forward movement of the massage tip 70 can be precisely adjusted via a forward movement carriage 92 that is linked to the massage carriage 170 so as to achieve an accurate pressure on the eyelid. Referring to FIGS. 21 and 22, the forward movement carriage 92 includes an upper half and a lower half interconnected via attachment pins / holes 97, whereby the forward movement carriage 92 slides within the housing 22 along the guide rail 172 via the feet 93 as a unit. The massage carriage 170 is separated and is individually slidable along the guide rail 172 via its respective feet 171. The massage carriage 170 carrying the massage arms 50 and their respective drive train components is movable individually relative to the forward movement carriage 92.

[0070] The forward movement carriage 92 includes a pin 31 that engages a slot 33 of an internal lever 32 that is operable via a treatment lever 30 to pivot relative to the housing 22 about a shaft 34. Forward actuation of the treatment lever 30 causes forward rotation (arrow F) of the internal lever 32. Rearward actuation of the treatment lever 30 causes rearward rotation (arrow R) of the internal lever 32. Through the engagement of the pin 31 within the slot 33, forward rotation of the internal lever 32 moves the forward movement carriage 92 and the massage carriage 170 forward along the guide rail 172. Rearward rotation of the internal lever 32 moves the forward movement carriage 92 and the massage carriage 170 rearward along the guide rail 172. Thus, when actuated to the forward position, the treatment lever 30 moves the forward movement carriage 92 and the massage carriage 170 to a forward extended position (see, e.g., FIGS. 5, 8, 11, 21, and 22). Similarly, when actuated to the rearward position (e.g., via a torsion spring 99 when released), the treatment lever 30 moves the forward movement carriage 92 and the massage carriage 170 to a rearward retracted position (see, e.g., FIGS. 3, 4, 6, and 7).

[0071] Referring to FIGS. 23 and 24, the forward movement carriage 92 carries a stepper motor 180 configured to individually bias the massage carriage 170 forward and backward relative to the forward movement carriage to achieve individual fine adjustments of the housing 22, the eye piece 80, and the massage arm 50 with respect to the patient's eyelids. FIGS. 23 and 24 show the lower half of the forward movement carriage 92 and its associated massage carriage 170, massage arm 50, and other components, but it will be understood that the upper half of the forward movement carriage and its associated components are configured and operate in the same manner.

[0072] The stepper motor 180 is operable to move the associated drive block 182 back and forth along the forward movement carriage 92. As shown in FIG. 24, the drive block 182 is received within a slot or channel 184 within the massage carriage 170 such that the drive block moves the massage forward and backward with respect to the forward movement carriage. A force sensor 186 is disposed within the channel 184. When the stepper motor 180 moves the drive block 182 forward, the drive block 182 engages the force sensor 186 and applies a moving force to the force sensor attached to the carriage 170. Thus, the forward movement of the massage carriage 170 is transmitted from the forward movement of the carriage 92 through the force sensor 186. The force sensor 186 can be configured from firmware to stop the fine adjustment provided by the stepper motor when a predetermined force level is sensed due to the back action compression of the massage tip. This level can be calibrated for a given pressure that squeezes the eyelid and the massage tip by performing verification and validation tests. Thus, when the device 20 is latched and the position of the massage arm 50 is finely adjusted via the operation of the stepper motor in situ using the eyepiece 80 placed on the patient's eye, the stepper motor 180 can adjust the position of the massage tip 70 until a desired pressure (e.g., 2 psi) is reached. This fine adjustment can be performed individually for each of the upper and lower eyelids so that the device 20 can be finely adjusted to the patient's anatomical structure.

[0073] Once the device 20 is finely adjusted to apply a desired pressure to the eyelid, the device can be operated to apply a massage movement to the eyelid. The massage movement is configured to compress the meibomian gland, apply the massage movement in a single discharge direction, release the compression, and return to the starting point, where the compression is applied again and the massage movement is repeated, and can thus be generally described as a "milking" movement.

[0074] In the exemplary configuration disclosed herein, the milking massage motion is a square massage motion generally indicated by the square arrows in FIG. 16. The massage motion follows that described in the sequence shown in the table of FIG. 15. Noting that the motion is different for the upper and lower eyelids, i.e., opposite, the motion shown in FIG. 15 is the motion of the massage arm for the lower eyelid. The motion for the upper eyelid is opposite to that for the lower eyelid and can be interpolated from FIG. 15. The upward and downward motions can be easily achieved by inverting the massage carriage 170 and the components supported therein upside down. This rotational symmetry has the effect of rotating the cam in the opposite direction, e.g., clockwise for the lower eyelid and counterclockwise for the upper eyelid. Thus, both the upper and lower massage carriages 170, as well as the respective components supported therein, can be constructed with the same motor connection and the same inherent specifications, which means that there is no need for separate upper and lower 172 slider inventory management.

[0075] Referring to FIGS. 16 and 17-19, the LED array 100 can be arranged to direct light straight through a transparent massage tip 70 that can be constructed, for example, of silicone or polyurethane. In one exemplary configuration, the LED array 100 can be arranged in one or more parallel rows oriented to project light straight through the massage tip 70 as shown.

[0076] While a massage movement is being applied to the eyelid, the orifice of the Meibomian gland can be heated via the LED array 100. This heating reduces the viscosity of the Meibomian in the gland, which promotes the removal of blockages in the Meibomian flow in response to the massage movement applied via the massage arm 50. As shown in FIG. 16, the upper massage arm 50 moves in a square motion in the order of left, down, right, up. Similarly, the lower massage arm moves in the opposite square motion in the order of right, down, left, up. Through these movements, the massage effect on the eyelid, particularly the Meibomian gland, is a periodic application of pressure similar to a milking motion that squeezes the eyelid / gland and then moves in the direction of the gland orifice to discharge blockages, move the Meibomian, and then release the squeeze and return to the initial position so that the movement can be repeated.

[0077] From the foregoing description, those skilled in the art will understand improvements, changes, and modifications. These and other such improvements, changes, and modifications within the skill of those skilled in the art are intended to be encompassed by the appended claims.

Claims

1. An apparatus for massaging the eyelid to move the meibomian gland in one direction through the meibomian gland duct toward the gland duct orifice at the eyelid margin in order to remove blockage of the meibomian gland in the gland duct, the apparatus being configured to periodically apply pressure to an application area of the eyelid, move the applied pressure in a flow direction toward the gland duct orifice, and release the pressure applied to the application area of the eyelid, the apparatus comprising: An elongated massage arm configured to support a massage tip, the massage tip being configured to apply the pressure to the application area of the eyelid; A cam rotatable about a rotation axis and having a cam surface; A follower having a follower surface that slidably engages the cam surface; Comprising; The follower is configured to impart a massage motion to the massage arm in response to rotation of the cam; The cam surface has a curved configuration of a constant width; The cam is configured such that the center of the cam surface is offset from the rotation axis of the cam. An apparatus for massaging the eyelid.

2. The apparatus according to claim 1, wherein the cam and the follower are configured such that the massage motion follows a rectangular path.

3. The rectangular path is axially directed toward the eyelid to engage the application area, linearly follows the eyelid in the flow direction of the meibomian gland duct while engaged with the application area, axially departs from the eyelid to disengage from the application area, and is linearly formed in a direction opposite to the flow direction in a state of being disengaged from the application area. The apparatus according to claim 2, which is continuously configured.

4. The cam and the follower are configured such that the massage motion of the massage includes, in a repetitive cycle, A first movement including moving from an initial position to engage the application area of the eyelid and applying pressure to the application area of the eyelid; A second movement including moving in the flow direction toward the gland duct orifice while applying pressure to the application area; A third movement including moving away from the eyelid and disengaging from the eyelid; A fourth movement including returning to the initial position; The apparatus according to claim 1, which is configured to include the movement of.

5. The device according to claim 1, wherein the surface of the follower includes the surface of the massage arm.

6. The follower has an opening in the massage arm, the cam is positioned within the opening, the opening has a width greater than the width of the constant-width curve of the cam surface, and the width of the opening is configured to allow the cam to rotate within the opening while engaging the surface of the follower. The device according to claim 1.

7. The device according to claim 6, wherein the opening generally has a square shape.

8. The device according to claim 7, wherein the cam is configured such that the cam surface is always maintained in contact with all four sides of the square opening of the follower.

9. The device according to claim 1, further comprising a pin / slot mechanism for supporting the massage arm on the housing, the pin / slot mechanism including a fixed pin supported on the housing and a slot on the massage arm through which the pin extends, the massage arm being configured to pivot about the fixed pin and slide along the length of the slot on the fixed pin.

10. The device according to claim 1, wherein the cam and the follower are configured such that the rotational movement of the cam generates a rectangular movement of the massage tip.

11. The device according to claim 1, further comprising at least one infrared light source configured to heat the meibomian glands within the eyelid meibomian gland ducts through the massage tip, either independently of the massage movement of the massage tip or simultaneously with the movement of the massage tip.

12. The device according to claim 11, wherein the infrared light is emitted at a wavelength of about 900 nm to 1100 nm, preferably about 985 nm to 1015 nm.

13. The device according to claim 11, further comprising an eye shield configured to engage and cover at least a portion of the eye and disposed between the eye and the eyelid to shield the eye from the infrared light.

14. The device according to claim 13, wherein the eye shield further comprises at least one temperature sensor configured to sense the temperature in the area of the eye and eyelid exposed to the infrared light.

15. The device according to claim 13, wherein the eye shield comprises a translucent portion through which visible light can pass, and the translucent portion is configured to enable a camera to image the eyelid during treatment.

16. The device according to claim 12, wherein the massage tip is configured to allow infrared radiation to pass through and apply heat to the eyelid.

17. The device according to claim 13, further comprising a latch arm having a latch tip, wherein the latch tip is configured to move towards each other to a latched state in which the latch tip latches a tab portion of the eye shield to fix the eye shield to the device and restrict movement of the eye shield relative to the massage arm.

18. The device according to claim 17, wherein the device comprises a treatment arm operable from a retracted position to a treatment position, the treatment arm being configured to move the latch arm to the latched state when in the treatment position and to move the latch arm to the released state when in the retracted position, and the treatment arm includes a spring member configured to bias the treatment arm to the retracted state when released so that quick release of the eye shield tab portion is automatically achieved.

19. The device according to claim 18, wherein the treatment lever is also configured to control the operation of a forward positioning carriage carrying the massage arm, and the treatment lever is configured to linearly move the forward positioning carriage to position the massage arm in a retracted state when no massage motion is applied and in an extended position for applying a massage motion to the eyelid.

20. The device according to claim 1, further comprising an LED array arranged to provide light for optical heating, the LED array being configured to adjust its brightness to provide high-contrast imaging light for video imaging of the meibomian glands during a short period of heating.

21. The device according to claim 20, wherein the LED heating array is supported on a PCBA connected to a heat sink, and the PCBA also supports the attachment of a micro camera.

22. The device according to claim 21, wherein the eye shield further comprises a transparent portion including one or more embedded mirror surfaces, and the mirror surfaces are configured to redirect the main converging light rays of the micro camera toward the upper eyelid margin and the lower eyelid margin so that the micro camera can view the eyelid and the meibomian gland duct orifice laterally.

23. The device according to claim 20, further comprising a fan and a heat sink for cooling the LED array.

24. The device according to claim 20, further comprising a magnetic sensor electronically coupled to a kill switch for turning off the LED array in response to release of the treatment arm, the magnetic sensor actuating the kill switch by sensing the proximity of one or more magnets mounted on the treatment arm.

25. The device according to claim 1, wherein the periodically applied pressure is configured to be 8 psi or less.

Images