Devices and methods for treating dry eye

Abstract

The disclosure discloses a device for treating the eyelids or other body areas of a subject. The device includes a fiber bundle having a distal end and a proximal end. The proximal end is connectable to an optical coupler designed to be optically coupled to a light source. The device further includes a rigid tube and a cover member, wherein the rigid tube houses at least a portion of the distal end of the fiber bundle and the cover member is mounted around a portion of the rigid tube. The cover member is rotatable relative to the rigid tube during treatment of the eyelids of the subject. Rotation of the cover member relative to the rigid tube allows the device to be operated in different orientations as can be required during treatment of the eyelids.

Description

Technical Field

[0001] This invention relates to a medical device and method for treating dry eye syndrome. Background Technology

[0002] A major cause of dry eye is blepharitis, a chronic inflammation of the eyelid margin. This is because if the meibomian glands are inflamed for a long time, they produce too little or no secretions, leading to an unstable tear film. Chronic blepharitis is not easy to treat because it is often caused by pathogens such as bacteria and skin mites (Demodex mites).

[0003] For example, IPL (Intense Pulsed Light) treatment has been shown to have lasting effects and successfully eliminate bacteria and skin mites. IPL is a phototherapy that can be used to treat the inflammatory causes of dry eye, stimulate the meibomian glands, and accelerate healing. Other light sources, such as LEDs or lasers, can be used. The use of a light source is to generate heat and modulate the light to heat the area of ​​the meibomian glands; therefore, other heat-generating sources can be used.

[0004] U.S. Patent Nos. 9,333,370 and 10,085,814, assigned to the assignee of this invention, relate to the treatment of dry eye using light.

[0005] During treatment, several light pulses can be delivered to the patient's eyelids. Care should be taken to avoid direct light entering the cornea and to avoid exposing the eyelashes to energy (to prevent hair loss). Additionally, direct heating of the cornea and other ocular surfaces should be avoided.

[0006] Meibomian gland massage (MGX) is also a treatment method for MGD (meibomian gland dysfunction, or evaporative dry eye). It typically involves squeezing the glands after heating them with IPL energy, LED energy, or other energy sources to force out meibomian gland sebum. This is usually achieved by pressing the eyelid from the outside with a finger on a q-tip placed between the eyelid and sclera. Sometimes, special forceps or paddles are used for MGX.

[0007] Existing devices for treating dry eye are rigid during operation and may not be adjustable, for example, to change the orientation of the device, which may be necessary during treatment.

[0008] Therefore, an improved device is needed to overcome one or more of the above-mentioned limitations. Summary of the Invention

[0009] In one embodiment, the disclosed text discloses a device for treating the eyelids of a subject. The device includes a fiber bundle having a distal end and a proximal end. The proximal end is connectable to an optical coupler designed for optical coupling with a light source. The device also includes a rigid tube and a cover member, wherein the rigid tube accommodates at least a portion of the distal end of the fiber bundle, and the cover member is mounted around a portion of the rigid tube. During treatment of the subject's eyelids, the cover member is rotatable relative to the rigid tube.

[0010] In another embodiment, the disclosed text discloses a system for performing treatment on a subject's eyelids. The system may include a console. The console may include power electronics that supply power to a light-generating device such as an IPL or LED device. Where a laser is the light energy source for performing the eyelid treatment, the console may also include a laser source. The device includes a fiber bundle having a distal and a proximal end. The proximal end includes an optical coupler designed for optical coupling with a light source in the console when thus configured. The console itself may include a cavity into which the proximal end of the fiber bundle is inserted. Alternatively, the proximal end of the fiber bundle may be adapted to fit within a cavity of an IPL or other device head. Known IPL devices include a removable glass, sapphire, or other transparent member that contacts the patient's skin and is adapted to transmit light from the IPL source through the transparent member onto the patient's skin. These transparent members may be removable to accommodate transparent members of different sizes. After such a transparent member is removed, a cavity exists such that the proximal end of the fiber bundle can be inserted into the cavity through a suitable interface member. The device also includes a rigid tube and a cover member, wherein the rigid tube accommodates at least a portion of the distal end of the fiber bundle, and the cover member is mounted around a portion of the rigid tube. During treatment of the subject's eyelids, the cover component can rotate relative to the rigid tube.

[0011] In another embodiment, the disclosure discloses a method for treating blepharitis or meibomian gland dysfunction. The method includes treating the patient's eyelid with the device described above and squeezing the patient's eyelid to perform meibomian gland massage (MGX). Attached Figure Description

[0012] When read in conjunction with the accompanying drawings, the embodiments of the disclosure itself, as well as preferred modes of use, further objects, and advantages, will be best understood by referring to the following detailed description of illustrative embodiments. One or more embodiments will now be described by way of example only, with reference to the accompanying drawings, in which:

[0013] Figure 1 A non-limiting example of a device for treating a subject's eyelids, according to some embodiments of the published text, is shown in a perspective side view.

[0014] Figure 2 Some embodiments based on the published text are shown. Figure 1A perspective view of the device, showing the rotation of the cover member relative to the rigid tube.

[0015] Figure 3 Some embodiments based on the published text are shown. Figure 1 A top-view perspective view of the device, which is equipped with a switch for activating the device.

[0016] Figure 4 Some embodiments based on the published text are shown. Figure 1 A side view of the device.

[0017] Figure 5 The following are examples of connectable implementations based on the published text: Figure 1 A perspective view of a disposable plug for a rigid tube in a device.

[0018] Figure 6 Some embodiments based on the published text are shown. Figure 1 A schematic diagram of a device having electronic components for electrical connection to a control console.

[0019] Figure 7A and Figure 7B Some embodiments based on the published text are shown. Figure 1 A perspective view of the connector of the device, which can be connected to the console.

[0020] Figure 8 A perspective view of an IPL device according to some embodiments of the disclosed text is shown, the IPL device including a means for receiving Figure 7A and Figure 7B shown Figure 1 The cavity of the connector of the device.

[0021] The accompanying drawings illustrate embodiments of the disclosure for illustrative purposes only. Those skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods shown herein can be employed without departing from the principles of the disclosure described herein. Detailed Implementation

[0022] The features and technical advantages of the disclosed text have been broadly outlined above to facilitate a better understanding of the detailed description below. Those skilled in the art will understand that the disclosed concepts and specific embodiments can be readily used as the basis for modifying or designing other structures for performing the same purposes of the disclosed text. The novel features, as well as further objects and advantages, considered characteristics of the disclosed text regarding its organization and operation methods will be better understood from the following description when considered in conjunction with the accompanying drawings. However, it should be explicitly understood that each figure is provided for illustrative and descriptive purposes only and is not intended as a definition of limitation on the disclosed text.

[0023] Figure 1 A perspective side view of a device (100) for treating a subject's eyelids is shown. Here, "subject's eyelids" can generally refer to a person's eyelids; however, this should not be construed as a limitation of the published text. The device (100) can be used to treat dry eye syndrome or MGD (meibomian gland dysfunction). Figure 1 The illustrated device (100) includes a fiber bundle (101) having a distal end (101a) and a proximal end (101b). The fiber bundle (101) may be an optical fiber cable, also known as an optical fiber cable, which is a cable-like assembly but contains one or more optical fibers for transmitting light. For the light, the light source may be an intense pulsed light (IPL) or another light source, such as an LED. The fiber bundle (101) may also incorporate filters to allow wavelength selection and act as an energy damper to reduce the raw energy flow emitted by the light source to a level acceptable for eyelid treatment. In some embodiments, depending on the use, the fiber bundle (101) may be disposable or reusable. A typical fiber bundle (101) may contain thousands of optical fibers with plastic or silicone sheaths. The diameter of the achieved treatment area is in the range of 5 mm–8 mm (assuming a circular or semi-circular area).

[0024] In some embodiments, the proximal end (101b) of the fiber bundle (101) may be connected to the IPL head assembly [e.g., Figure 8 The device 107 shown, or connected to a main console having a similar socket configured to receive the proximal end (101b) of the fiber bundle (101), as described above. Furthermore, a portion near the proximal end (101b) of the fiber bundle (101) may be accommodated in a flexible member (108). The flexible member (108) may also be referred to as an umbilical cord. The fiber bundle (101) extending from the IPL device or any other console [not shown] may be accommodated within the flexible member (108) for a predetermined distance. Beyond this distance, and generally toward the distal end (101a) of the fiber, the fiber bundle (101) may be accommodated within a rigid tube (102). In some embodiments, the rigid tube (102) may be made of a metallic or plastic material. In some embodiments, the rigid tube (102) may be made of a composite material. The rigid tube (102) may be a hollow tubular member that receives the distal portion of the fiber bundle (101).

[0025] In addition, such as Figure 1As shown, the device (100) includes a cover member (103) mounted around a rigid tube (102). A cross-section of the cover member is shown in the figure to allow for the illustration of the rigid tube (102) passing through it. In some embodiments, the cover member (103) may be mounted only around the rigid tube (102) and not around the flexible member (108). The cover member (103) can be used by the operator of the device (100) to hold and handle the device (100). The cover member (103) may be made of a polymeric material, such as, but not limited to, plastic. The cover member (103) may be mounted around the rigid tube (102) such that it is freely rotatable relative to the rigid tube (102). This free rotation of the cover member (103) allows the operator to change the orientation of the device (100) as needed during treatment, thereby facilitating better treatment of dry eye in a person.

[0026] In some embodiments, free relative rotation of the cover member (103) about the rigid tube (102) can be facilitated by at least one bearing (105) installed between the rigid tube (102) and the cover member (103). The bearing (105) can be as follows: Figure 1 The bearing (105) is shown positioned on the distal side of the flexible member (108). However, the location of the bearing (105) should not be construed as a limitation of the disclosed text, as it can be installed anywhere along the intersecting path between the cover member (103) and the rigid tube (102). In some embodiments, the diameter of the rigid tube (102) may be increased to the point where the bearing (105) is positioned, and then the diameter may be reduced in the distal direction. In some embodiments, another metal tube may be mounted around the rigid tube (102) and extend to the point where the bearing (105) is positioned.

[0027] Now for reference Figure 2 This figure shows a perspective view of the device (100). As can be seen, the cover member (103) can be configured such that it can rotate freely about the longitudinal axis (AA) of the rigid tube (102). During rotation, as the name suggests, the rigid tube (102) is rigid, and only the cover member (103) can rotate about the longitudinal axis (AA) to allow the operator to operate the device (100) in different orientations during treatment. Since the cover member (103) can rotate freely about the rigid tube (102), rotating the cover member (103) will not cause the rigid tube (102) to rotate and will not generate torque on the rigid tube (102) or the fiber bundle (101).

[0028] Figure 3A switch (109) disposed on the cover member (103) of the device (100) is shown; this switch may also be implemented as a trigger or a button. During treatment, the switch (109) can be selectively operated to an on or off state as needed. The on device (100) allows light from an IPL or other source to pass through the fiber bundle (101) used for treatment. In some embodiments, the switch (109) may be permanently off and can be operated to an on state by an operator.

[0029] Figure 4 A side view of the device (100) is shown. As shown, the cover member (103) defines a distal protrusion (103a) that facilitates the connection between the cover member (103) and... Figure 5 The connection of the removable / disposable tip (104) is shown. In some embodiments, there may be more than one protrusion (103a) that allows connection between the cover member (103) and the disposable tip (104). In some embodiments, the disposable tip (104) may define one or more protrusions, and the cover member (103) may define a notch to allow assembly of the disposable tip (104) and the cover member (103), and therefore, the assembly method should not be construed as a limitation of the disclosed text. Furthermore, the rigid tube (102) may define a slit (102a) that allows the disposable tip (104) to be disposed on the rigid tube (102). The slit (102a) may extend circumferentially around the rigid tube (102). In some embodiments, the disposable tip (104) may define a slit to allow the disposable tip (104) to be disposed above the rigid tube (102).

[0030] Now for reference Figure 5 The diagram shows a frontal and rear-view perspective view of a disposable tip (104) that can be used to treat a subject's eyelid. The disposable or removable tip (104) can be made of a biocompatible, transparent or translucent material, such as silicone or polycarbonate, which allows light energy to be delivered to the eyelid. The disposable tip (104) can be provided in a clean / sterile state or packaged, for example, one per patient or one per eye, to allow for hygienic treatment of each patient. During the procedure, the package of the disposable tip can be opened, and the disposable tip (104) can be attached to the distal end (101a) of the fiber bundle (101). Attachment can be achieved using adhesives or force-fitting mechanisms (friction between the sides of the fiber bundle 101 and the annular portion of the disposable tip (104) surrounding the fiber bundle (101), snap-fit ​​and release mechanisms, or shape-fitting mechanisms (e.g., by thread).

[0031] During treatment, a light beam can be transmitted via a fiber bundle (101) from its proximal end (101b) to its distal end (101a) and then into a disposable tip (104). The disposable tip (104) transmits the light beam to the patient's eyelid via a contact surface (104a). A rounded, solid, or soft tip allows for a comfortable interface for physical contact between the disposable tip (104) and the eyelid. The contact surface (104a) of the disposable tip (104) can also be curved, such that the softness of the material distributes force and pressure across the eyelid upon contact. In some embodiments, the contact surface (104a) of the disposable tip (104) can have a concave shape, which allows for better conformation to the natural curvature of the eyelid.

[0032] like Figure 5 As shown, the disposable tip (104) may be defined with a plurality of notches (104c). As an example, there may be four notches (104c) that define the circumference of the disposable tip (104). One of these notches (104c) may be aligned with a protrusion (103a) in the cover member (103) to facilitate the connection between the disposable tip (104) and the cover member (103). Since the cover member (103) and the disposable tip (104) are assembled together, any rotation of the cover member (103) about the longitudinal axis (AA) of the rigid tube (102) will also cause the disposable tip (104) to rotate. Therefore, the cover member (103) may rotate together with the disposable tip (104) about the longitudinal axis (AA) of the rigid tube (102). As described above, such joint rotation of the disposable tip (104) and the cover member (103) will not cause the rigid tube (102) or the fiber bundle (101) to rotate or generate any torque thereon.

[0033] Advantageously, the free rotation of the disposable tip (104) and the cover member (103) allows the device (100) to be operated in different orientations during eyelid treatment, and thus the contact surface (104a) of the disposable tip (104) can contact the eyelid as needed and is suitable for treatment. For example, during treatment, if the vertical portion of the contact surface (104a) of the disposable tip (104) is set to contact the eyelid, the operator can simply adjust the rotation of the cover member (103) and the disposable tip (104) to achieve the desired contact with the eyelid. The operator can determine the orientation based on factors such as, but not limited to, the required contact area between the contact surface (104a) of the disposable tip (104) and the eyelid.

[0034] In addition, such as Figure 5As shown, the disposable tip (104) may have a protrusion (104b) defined on its inner surface. The protrusion (104b) allows the disposable tip (104) to be positioned on a rigid tube (102) at the distal end (101a) of the fiber bundle (101). The protrusion (104b) may be provided on a slit (102a) defined on the rigid tube (102) for connection between the disposable tip (104) and the rigid tube (102). In some embodiments, the rigid tube (102) may have a protrusion defined, and the disposable tip (104) may have a matching slit defined for positioning the disposable tip (104) on the rigid tube (102) while still allowing the disposable tip (104) to rotate freely relative to the rigid tube (102).

[0035] Figure 6 A top view of the device (100) is shown. The enclosure component (103) can be configured to house multiple electronic components (110), such as, but not limited to, a processor chip, radio frequency identification (RFID), and one or more batteries. These components can allow the device to connect to an external console via wired or wireless means. Wired / wireless connections can aid in tasks such as, but not limited to, data transmission. The electronic components within the device (100) may include Bluetooth or Wi-Fi or other components. Because the flexible component (108) contains only optical fibers, this is important when there is no wired connection between the device (100) and the console, and thus, the on / off switch (109) needs to be connected to a device that will activate an IPL or other light source when pressed or moved. On the console, it is possible to... Figure 6 The so-called encryption lock (111) shown is capable of intercepting over-the-air Bluetooth or other wireless signals and enabling the activation of IPL or other light sources. In some embodiments, the wireless connection can utilize infrared (IR) signals, in which case pressing the on / off switch (109) can emit an IR beam from an IR LED located on the device. The IR signal (beam) is received by a corresponding sensor in the console or in the room where the console is placed. The IR signal can also be transmitted to the console via one or more optical fibers within a fiber bundle (101). The wireless functionality can be powered by conventional batteries, rechargeable batteries, dedicated charging bases, and / or solar / photovoltaic cells, etc. In some embodiments, Figure 1 The fiber bundle (101) shown may have wires configured to establish an electrical connection between the device (100) and the control console.

[0036] Figure 7A and Figure 7BA connector (106) is shown that can be disposed at the proximal end (101b) of the fiber bundle (101). In some embodiments, the connector (106) can be inserted into or plugged into a cavity (107a) of the IPL head assembly (107). However, the connector (106) can also be inserted directly into a cavity defined in a control unit (not shown), and this should not be construed as a limitation of the disclosed text. Figure 7B As shown, the connector (106) may have a magnet (106a) designed to stimulate a reed switch within the IPL head assembly (107). In another example, the connector (106) may include a contact pin or RFID mechanism that inserts into a cavity of the IPL assembly or console along with the connector (106). Providing a contact pin / RFID to identify the device (100) inserted into the IPL assembly (107) allows for the initiation of activation of light energy and the extent to which it passes through the fiber bundle (101).

[0037] In some embodiments of the disclosed text, rotation of the disposable tip (104) together with the cover member (103) about the longitudinal axis (AA) of the rigid tube (102) allows the device to be operated in various orientations, thereby helping the operator to achieve the desired contact with the eyelid through the contact surface (104A) of the disposable tip (104), as may be required during treatment.

[0038] In some embodiments disclosed in the text, the device (100) is easy to use, ergonomically designed, and lightweight.

[0039] Regarding the use of virtually any plural and / or singular terms herein, those skilled in the art can convert plural to singular and / or singular to plural as needed by the context and / or application. For clarity, various singular / plural substitutions may be explicitly described herein.

[0040] Those skilled in the art will understand that, in general, the terms used herein, and are generally intended to be “open-ended” terms, such as the terms “comprising” and “including” should be interpreted as “including / including but not limited to,” and the term “having” should be interpreted as “having at least,” etc. Those skilled in the art will also understand that, to aid understanding, detailed descriptions may include the use of introductory phrases “at least one” and “one or more” to introduce the claim statement. However, the use of such words should not be construed as implying that a claim statement introduced by the indefinite article “a” or “an” limits any particular claim containing such an introductory claim statement to containing only one such feature of the invention, even though when the same claim includes the introductory phrase “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and / or “an”) should generally be interpreted as meaning “at least one” or “one or more”; the same applies to the use of definite articles to introduce the claim statement. Furthermore, even if the statement of the introduced claim explicitly describes a specific number, those skilled in the art should recognize that such a statement should generally be interpreted as meaning at least the number described. For example, a simple statement of "two statements" without any other modifiers generally means at least two statements or two or more statements.

[0041] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting; the true scope and spirit are indicated by the accompanying detailed description.

[0042] Figure label:

[0043] Figure Labels describe 100 Device for treating eyelids 101 fiber bundle 101a distal end of fiber bundle 101b Proximal end of fiber bundle 102 rigid tube 102a Slit 103 Cover components 103a Protrusions of the cover component 104 One-time top 104a Contact surface 104b protrusion 104c gap 105 bearings 106 connector 106a Contact pin 107 IPL device 107a cavity 108 Flexible components 109 switch 110 Electronic components 111 dongle

Claims

1. A device (100) for treating the eyelids of a subject, the device (100) comprising: A fiber bundle (101) having a distal end (101a) and a proximal end (101b), wherein the proximal end (101b) is capable of being connected to an optical coupler designed to be optically coupled to a light source; A rigid tube (102) that at least accommodates a portion of the distal end (101a) of the fiber bundle (101); and A cover member (103) is mounted around a portion of the rigid tube (102). The cover member (103) is rotatable relative to the rigid tube (102) during treatment of the subject's eyelids using light from the light source, and rotating the cover member (103) does not cause the rigid tube (102) to rotate and does not generate torque on the rigid tube (102) or the fiber bundle (101). The cover member (103) is configured to be connected to a disposable tip (104) that can be received by the free end of the rigid tube (102), such that when the disposable tip (104) is connected to the cover member (103), the cover member (103) and the disposable tip (104) can rotate together relative to the rigid tube (102).

2. The device (100) of claim 1, comprising the disposable tip (104) removably coupled to the cover member (103), wherein the disposable tip (104) includes a contact surface (104a) for contacting the eyelid of the subject.

3. The device (100) according to claim 1, comprising the disposable tip (104) fixedly connected to the cover member (103), wherein the disposable tip (104) includes a contact surface (104a) for contacting the eyelid of the subject.

4. The device (100) according to claim 2, wherein the contact surface (104a) of the disposable tip (104) is made of a biocompatible material.

5. The device (100) according to claim 1, wherein the cover member (103) is made of a polymer material.

6. The device (100) according to claim 1, wherein the rigid tube (102) is made of a metal component.

7. The device (100) according to claim 1, comprising at least one bearing (105) mounted between the rigid tube (102) and the cover member (103) to allow relative rotation of the cover member (103) relative to the rigid tube (102).

8. The device (100) according to claim 1, wherein the cover member (103) is configured to rotate about the longitudinal axis AA of the rigid tube (102).

9. The device (100) according to claim 1, wherein the proximal end (101b) of the fiber bundle (101) includes a connector (106) configured to be connected to the optical coupler.

10. The apparatus (100) of claim 9, wherein the light source includes a cavity (107a) that forms the optical coupler to accommodate the connector (106).

11. The device (100) according to claim 9, wherein the connector (106) is defined with at least one contact pin (106a) to sense and identify the insertion of the device (100) into the light source.

12. The device (100) according to claim 2 or 3, wherein the rigid tube (102) is defined with a slit (102a) to receive a protrusion (104b) of the disposable tip (104) and to allow the disposable tip (104) to rotate relative to the rigid tube (102).

13. The device (100) of claim 2, wherein the cover member (103) includes a protrusion (103a) and the disposable tip (104) is defined with a plurality of notches (104c) to facilitate assembly of the cover member (103) with the disposable tip (104) through at least one of the plurality of notches (104c).

14. The device (100) according to claim 1, wherein a portion of the fiber bundle (101) is received by a flexible member (108) at the proximal end (101b).

15. A system for performing treatment on the eyelids of a subject, the system comprising: The device (100) according to any one of claims 1 to 14; and A console configured to receive a light source, wherein the console is defined with a cavity to allow connection of the device (100).

16. The system of claim 15, wherein the console is configured to accommodate the IPL device (107).

17. The system of claim 16, wherein the IPL device (107) is defined having a cavity (107a) to accommodate the device (100).

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