• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Device for separating the eyelid from a patient in intravitreal injection of medicinal substances procedures, comprising an ergonomic distal sector to come into contact with the corneo-scleral limbus of the patient's eye, at least one hole for introducing a needle from a syringe, presenting a hook-shaped flange to come into contact with the upper eyelid of the patient, the device further comprising a handle geometrically adapted to be held with the fingers and to exert traction on the upper eyelid of the patient by means of the shaped flange. hook with the patient in a supine position. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2768473A1
    申请号:ES201831263
    申请日:2018-12-21
    公开日:2020-06-22
    发明作者:Aramburu Gonzaga Garay；Arizmendiarrieta Xabier Sanchez
    申请人:Mizar Additive Manufacturing S L U；Administracion General de la Comunidad Autonoma de Euskadi；
    IPC主号:
    专利说明:

    [0002] DEVICE FOR THE SEPARATION OF THE PATIENT'S EYELID
    [0004] OBJECT OF THE INVENTION
    [0006] The present application refers to a device for the separation of the eyelid, location of the injection site and orientation of the needle in procedures for intravitreal injection of medicinal substances.
    [0008] BACKGROUND OF THE INVENTION
    [0010] The use of devices for eyelid separation in intravitreal injection procedures is known. Such intravitreal injections are necessary in patients with pathologies such as macular degeneration, diabetes and other retinal diseases.
    [0012] Currently, devices for separating the eyelid, called blepharostats, and different types of markers are used in the injection process. The injection should be made at 3.5 mm in patients with cataract surgery and at 4 mm in those who are not.
    [0014] In the documents known in the state of the art by the applicant, the method of separating the eyelid consists of gently pushing and thus separating the eyelid to proceed with the intravitreal injection of medicinal substances. This results in an unsafe process since it is being held by light pressure or push without preventing the patient from closing the eye during the process.
    [0016] Additionally, the devices known to the applicant have holes with a concave surface, limiting their use to certain types of syringes or needles of specific shapes.
    [0018] Known devices comprise holes with constant distances from the hole to the center of the vitreous cavity. However, for patients operated on for cataracts this distance should be less, more particularly about 3.5 mm compared to 4 mm for the rest of patients. For the Therefore, it is necessary to manufacture with different distances and geometries depending on each patient, making it difficult and expensive to produce large-scale disposable devices.
    [0020] The injection assistant "InVitria 4”, by InVitria®, designed by Arnaldo Gongalves, is based on a disposable device for intravitreal injections configured to obtain a position with a fixed injection angle. The proposed method of fixing the upper eyelid is based on in pushing the device towards the eye and turning, thus leaving the eye exposed to receive the injection through the hole designed for it. However, the InVitria® device does not have a fixed lid on the eyelid due to traction, thus offering less security against movements abrupt, in addition to the discomfort it causes the patient. The injection assistant "InVitria 4" presents a unique injection distance of 3.5mm with respect to the corneo-scleral limbus. This is valid for patients operated on for cataracts, however, this distance should preferably be 4 mm for the rest of the patients.
    [0022] Patent application EP2109425 (A1), with applicant Arnaldo Gongalves, discloses a device for intraocular administration of a substance by means of a hypodermic needle. It comprises a support element to be placed on the eye and a hole in said support, arranged perpendicular to the surface of the eye and configured to introduce the hypodermic needle. However, the proposed device does not comprise traction means to separate the upper eyelid, the proposed method of fixing said eyelid is based on the pressure applied to the support on the surface of the eye.
    [0024] Patent application EP2017266045 (A1), with applicant VISIONITY OY [FI], discloses an ocular therapeutic tool that includes a hollow body connected to a base, where said base is adapted to be placed on the surface of the eye. The invention proposed in this application also comprises an injection guide connectable to the hollow body and adapted to receive a needle. However, the proposed invention is not a one-piece tool, with the drawback of the fragility of these structures. Furthermore, the tool does not include tabs, nor other elements whose functionality is to separate the eyelid.
    [0026] Patent application AU2015201289 (A1), with applicant NAT NAT SANTE RECH MED, discloses a device for injecting an eye product, comprising a injection needle, a support configured to perform 5 movements of the needle; and where said device comprises a location mark fixed on the support that is located in contact with the eye region where the injection occurs. This device is mainly focused on a device where the injection needle has freedom of movement, however, it does not propose an additional method based on tabs or hooks to exert traction on the patient's upper eyelid.
    [0028] US patent application US2014094752 (A1), with applicant HILES JOHN [GB]; SANOFI AVENTIS DEUTSCHLAND [DE], describes a guiding device for an intraocular injection, comprising a base with an inner and an outer surface. Said base in turn comprises a handle on the outer surface and a through hole on both surfaces; and where the inner surface is adapted to be in contact with the eyeball. This invention does not propose any method of pulling the eyelid apart, nor does it provide structural differences to vary the distance with respect to the corneo-scleral limbus, at which the injection is to be performed.
    [0030] DESCRIPTION OF THE INVENTION
    [0032] The present invention aims to solve some of the problems mentioned in the state of the art.
    [0034] More specifically, the present invention describes a device that facilitates the intravitreal injection process by locating the injection point, guiding the injection needle towards the center of the vitreous cavity, providing greater safety for the patient and simplifying the process with fewer parts with with respect to the devices known in the state of the art.
    [0036] More in particular, the present invention discloses a device for separating the eyelid from a patient in intravitreal injection of medicinal substances procedures, comprising:
    [0037] - A distal sector further comprising a body and a flange, in which the body comprises a curved anterior face intended to come into contact with the corneo-scleral limbus of a patient's eye and in which said body it has at least one hole adapted for inserting a needle from a syringe.
    [0038] - An elongated handle that extends from the body of the distal end and is located at the opposite end of the distal sector of the device.
    [0040] In which the tab has a hook shape to come into contact with the upper eyelid of the patient and in which the device has a longitudinal geometry from its distal sector to the handle, capable of exerting traction on the upper eyelid of the patient by means of the hook-shaped tab with the patient in a supine position.
    [0042] By means of the technical characteristics mentioned above, the patient's upper eyelid is provided with a traction support, allowing a safer procedure.
    [0044] The device is preferably a single piece. That is, it forms a single body of a single piece, allowing a more robust device, thus avoiding mechanisms that can fracture, decouple or pieces that can be lost. Fundamentally, avoiding a possible and dangerous fracture between the pieces during intravitreal injection.
    [0046] More preferably, the device forms a curvilinear longitudinal body from the distal sector to the handle, allowing for comfortable pulling by lever with the fingers of one hand.
    [0048] Preferably the hole for introducing the syringe is straight, which allows using different types of needles with different types of shape.
    [0050] More preferably, the device has a visualization opening in the body of the distal sector, which allows examining the behavior of the eye while applying the intravitreal injection.
    [0052] The distal end adapted to come into contact with the corneo-scleral limbus of the patient's eye may be in the form of an arch.
    [0053] Preferably, the hole comprises a distance of approximately 4 mm to the junction with the corneo-scleral limbus. This distance is adequate for patients who have not undergone cataract surgery.
    [0055] More preferably, the device has a second hole with a different distance to the corneo-scleral or limbus junction, with respect to the distance from the first hole.
    [0057] Preferably, said distance from the second hole is approximately 3.5 mm. This distance being adequate for patients who have undergone cataract surgery.
    [0059] DESCRIPTION OF THE DRAWINGS
    [0061] To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, in accordance with a preferred example of practical embodiment thereof, a set of drawings is included as an integral part of said description. where, by way of illustration and not limitation, the following has been represented:
    [0063] Figure 1.- Shows a rear perspective view of the device according to a preferred embodiment of the present invention.
    [0065] Figure 2.- Shows an enlarged view of the distal sector of the eyelid separation device according to the preferred embodiment, where the through holes, the visualization opening and the hook-shaped tab of the separation device are clearly shown in the distal sector. of the eyelid.
    [0067] Figure 3.- Shows a side view of the device according to the preferred embodiment of the invention.
    [0069] Figure 4.- Shows a rear view of the distal sector according to the preferred embodiment of the device for separating the eyelid of a patient for intravitreal injections where the body is clearly shown in the distal sector, which includes the through holes and the asymmetry is also observed in the distance to the center of the vitreous cavity.
    [0070] PREFERRED EMBODIMENT OF THE INVENTION
    [0072] Figure 1 shows a perspective view of a preferred embodiment of the invention of a device (1) for the separation of the eyelid of a patient in intravitreal injection of medicinal substances procedures, comprising a distal sector (9) geometrically adapted to enter in contact with the corneo-scleral limbus of the patient's eye (8), said distal sector (9) further comprises a body (10) and a flange (2). The body (10) comprises two holes (3) in order to guide a needle of an intravitreal injection syringe to the ideal location of the center of the intravitreal cavity, each hole in the preferred embodiment presents a straight, smooth and through surface. Each hole presents different distances to the corneo-scleral junction or limbus of one eye (8) of the patient. One of the holes (3) has a distance of 3.5 mm, intended for patients who have suffered from cataracts, and the other hole (3) has a distance of 4 mm for patients who have not suffered from cataracts (see Figure 4). . The body further comprises a curved front face (6).
    [0074] Figure 2 shows an enlarged view of the distal sector (9) supported by the corneo-scleral limbus of the eye (8). Said distal sector (9), as shown in Figure 2, has a hook-shaped flange (2) to come into contact with the upper eyelid of the patient. The distal sector also includes a visualization opening (5) that transversely crosses the body (10) that allows the behavior of the eye to be examined while the intravitreal injection is applied, mainly to rule out blood vessels.
    [0076] The device (1) comprises an elongated handle (4) that extends from the body (10) and is located at the opposite end of the distal sector (9) of the device (1). The handle is ergonomically adapted to be held with the fingers and to exert traction on the upper eyelid of the patient by means of the hook-shaped tab (2) with the patient in a supine position.
    [0078] Figure 3 shows a side view of the device (1) according to the preferred embodiment of the invention. Said device (1) in the described preferred embodiment, forms a substantially curvilinear body in its longitudinal direction, that is, from the handle (4) to its distal sector (9). Preferably, it forms a curvilinear body with an odd symmetrical function, as shown in figure 3. This way it is facilitated application to the patient in the supine position and traction on the upper eyelid is facilitated by means of a lever, comfortably carried out with the fingers of one hand.
    [0080] Note, that the device (1) in the described preferred embodiment comprises a single piece, allowing a more robust device, thus avoiding mechanisms that can fracture, decouple or pieces that can be lost. Fundamentally, avoiding a possible and dangerous fracture between the pieces during intravitreal injection.
    [0082] Figure 4 shows a rear view of the device according to the preferred embodiment of which the through holes (3) in the body (10) and the asymmetry in the distance to the sclerocorneal limbus, more specifically a hole (3) approximately at 3.5 mm for patients who have undergone cataracts and the other hole (3) with a 0.5mm gap, 4 mm from the center of the vitreous cavity.
    权利要求:
    Claims (9)
    [1]
    1. Device (1) for separating the eyelid from a patient in intravitreal injection of medicinal substances procedures, comprising:
    - A distal sector (9) further comprising a body (10) and a flange (2), in which the body comprises a curved anterior face (6) intended to come into contact with the corneo-scleral limbus of an eye (8 ) of a patient and in which said body (10) has at least one hole (3) adapted to introduce a needle from a syringe (11).
    - An elongated handle (4) that extends from the body (10) and is located at the opposite end of the distal sector (9) of the device (1).
    characterized in that the flange (2) has a hook shape to contact the upper eyelid of the patient and in which the handle (4) forms a longitudinal geometry from its distal sector (9) to the handle (4), suitable to exert traction on the upper eyelid of the patient by means of the hook-shaped tab (2) with the patient in a supine position.
    [2]
    2. Device according to claim 1, characterized in that the device (1) forms a single body from a single piece.
    [3]
    3. Device according to any of the preceding claims, characterized in that it comprises a viewing opening (5) that transversely crosses the body (10) located in the distal section (9).
    [4]
    Device according to any of the preceding claims, characterized in that it forms a curvilinear longitudinal body from the distal sector (9) to the handle (4).
    [5]
    Device according to any of the preceding claims, characterized in that the curved front face (6) of the body (10) in the distal sector (9) has an arc shape.
    [6]
    Device according to any of the preceding claims, characterized in that at least one hole (3) is directed towards the center of the vitreous cavity.
    [7]
    Device according to any of the preceding claims, characterized in that the device has a second hole (3) with a distance to the corneo-scleral limbus different from that of the first hole.
    [8]
    Device according to claim 6, characterized in that the first hole has a distance of approximately 4 mm to the corneo-scleral limbus.
    [9]
    9. Device according to claim 7, characterized in that the distance of the second hole is approximately 3.5 mm.
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    同族专利:
    公开号 | 公开日
    EP3897398A1|2021-10-27|
    ES2768473B2|2021-05-21|
    WO2020127978A1|2020-06-25|
    CO2021009361A2|2021-10-29|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US5441040A|1994-02-02|1995-08-15|Williams, Jr.; Barney K.|RDS speculum|
    US5762606A|1997-05-16|1998-06-09|Minnich; Thomas E.|Combined eyelid retractor and eye flushing device|
    US20020103421A1|2001-01-29|2002-08-01|Putrino Charles R.|Eyelid retraction device|
    US6440065B1|2001-10-01|2002-08-27|The Nemours Foundation|Single-use disposable eyelid speculum, eye examination kit, and method for examining a patient's eye|
    US20070005016A1|2005-06-20|2007-01-04|Williams David F|Ocular injection device and method|
    GB2476307A|2009-12-21|2011-06-22|Norfolk & Norwich University Hospitals Nhs Foundation Trust|Ocular guide device|
    US20170042529A1|2015-08-13|2017-02-16|Shugarman Surgical Innovations, LLC|Eyelid speculum|
    NL1033357C2|2007-02-08|2008-08-11|Arnaldo Goncalves|Substance i.e. medication, intraocular administration device for e.g. human eye, has support element structured to be placed on eye and directing unit orienting hypodermic needle relative to eye, where element includes handle|
    AU2015201289B2|2008-03-14|2016-12-01|Institut National De La Sante Et De La Recherche Medicale|Eye injection device|
    US8287494B2|2009-03-23|2012-10-16|Colin Ma|Intravitreal injection devices and methods of injecting a substance into the vitreous chamber of the eye|
    EP2522318A1|2011-05-12|2012-11-14|Sanofi-Aventis Deutschland GmbH|Guide device for intraocular injection|
    NL2015198B1|2015-07-21|2017-02-07|Mechiel Hubert Schellekens Kari|Intravitreal injection device and bevacizumab for use in a method of preventing, treating or delaying macular degeneration or macular diabetic edema.|
    法律状态:
    2020-06-22| BA2A| Patent application published|Ref document number: 2768473 Country of ref document: ES Kind code of ref document: A1 Effective date: 20200622 |
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    优先权:
    申请号 | 申请日 | 专利标题
    ES201831263A|ES2768473B2|2018-12-21|2018-12-21|DEVICE FOR THE SEPARATION OF THE EYELID OF A PATIENT|ES201831263A| ES2768473B2|2018-12-21|2018-12-21|DEVICE FOR THE SEPARATION OF THE EYELID OF A PATIENT|
    EP19829202.1A| EP3897398A1|2018-12-21|2019-12-20|Device for separating a patient's eyelid|
    PCT/EP2019/086689| WO2020127978A1|2018-12-21|2019-12-20|Device for separating a patient's eyelid|
    CONC2021/0009361A| CO2021009361A2|2018-12-21|2021-07-16|Device for the separation of the eyelid of a patient|
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