NL2016032A - Illuminated localization device for brachytherapy of intraocular tumors. - Google Patents

Illuminated localization device for brachytherapy of intraocular tumors. Download PDF

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Publication number
NL2016032A
NL2016032A NL2016032A NL2016032A NL2016032A NL 2016032 A NL2016032 A NL 2016032A NL 2016032 A NL2016032 A NL 2016032A NL 2016032 A NL2016032 A NL 2016032A NL 2016032 A NL2016032 A NL 2016032A
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Netherlands
Prior art keywords
illuminated
localization device
eye
brachytherapy
shaped part
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NL2016032A
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Dutch (nl)
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NL2016032B1 (en
Inventor
Coliene Dam-Huisman Adriaantje
Ferdinand Eckardt Claus
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Crea Ip B V
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Priority to NL2016032A priority Critical patent/NL2016032B1/en
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Publication of NL2016032B1 publication Critical patent/NL2016032B1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/0008—Apparatus for testing the eyes; Instruments for examining the eyes provided with illuminating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/306—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using optical fibres

Abstract

Illuminated localization device with a holder body (2), an optical assembly (3) extending from the holder body (2) and comprising an optical radiation conductor (5) and a surrounding sleeve (3a, 3b) of a shape retaining material. The optical assembly (3) has a straight part (3a) and a ring shaped part (3b), the ring shaped part (3b) being positioned remote from the holder body (2) and having a main ring surface (7). The ring shaped part (3b) has light exit apertures (4) directed normal to the main ring surface (7). The ring shaped part (3b) may further have marker elements (6) extending in a direction normal to the main ring surface (7).

Description

Illuminated localization device for brachytherapv of intraocular tumors Field of the invention
The present invention relates to an illuminated localization device, comprising a holder body, an optical assembly extending from the holder body and comprising an optical radiation conductor (e.g. an optical fiber) and a surrounding sleeve of a shape retaining material.
Prior art
American patent publication US-A-5,582,608 discloses an apparatus for illuminating an eye undergoing eye surgery, the apparatus comprising light emitting means, e.g. in the arms of an eyelid speculum assembly, for providing a lamellar illumination of the eye. In one embodiment the light emitting means are provided in a fixation ring applied in eye surgery.
Summary of the invention
The present invention seeks to provide an easy to use illuminated localization device, especially suited for determining the location and extension of the basis of an intraocular tumor and projecting this information on the eye’s external surface (sclera). This information is used in brachytherapy of intraocular tumors in order to place (and fixate) a radioactive plaque in a correct position at the outer sclera.
According to the present invention, an illuminated localization device according to the preamble defined above is provided, wherein the optical assembly has a straight part and a ring shaped part, the ring shaped part being positioned remote from the holder body and having a main ring surface, the ring shaped part comprising a plurality of light exit apertures directed normal to the main ring surface. This allows a surgeon to accurately determine the position of a tumor, and mark the sclera accordingly for further steps in a brachytherapy procedure.
In a further aspect, the present invention relates to a method of using an illuminated localization device according to any one of the embodiments disclosed herein, comprising positioning the ring shaped part of the illuminated localization device in contact with a patient’s eye, with the light apertures directed to the eye, observing light points from the light apertures inside the eye, positioning the ring shaped part around an eye tissue part to be treated by brachytherapy, and attaching a brachytherapy plaque to cover the eye tissue part to be treated. This allows precise positioning of the brachytherapy plaque and hence a better efficient treatment of the tumor.
Short description of drawings
The present invention will be discussed in more detail below, using a number of exemplary embodiments, with reference to the attached drawings, in which
Fig. 1 shows a side view of an illuminated localization device according to an embodiment of the present invention;
Fig. 2 shows a partial view of the illuminated localization device of Fig. 1 in use;
Fig. 3 shows an enlarged view of a ring shaped part of a further embodiment of the illuminated localization device;
Fig. 4 shows a cross sectional view of the ring shaped part of Fig. 3 along the lines IV-IV; and
Fig. 5 shows a cross sectional view of the ring shaped part of Fig. 3 along the lines V-V.
Detailed description of exemplary embodiments
The present invention relates to a medical tool, in particular an illuminated localization device, which can be used for improving efficiency and accuracy in radiation treatment of an eye tumor, such as an eye melanoma. The radiation is usually delivered to the tumor by placing a radioactive plaque on a patient’s eye, directly over the tumor in a procedure called brachytherapy. The plaque is held in place with sutures. The plaque may comprise ruthenium or may comprise radioactive seeds, e.g. iridium or iodine. The plaque remains in place for a couple of days before it is removed. The exact localization of the tumor and the projection of its basis on the sclera is a precondition for a successful brachytherapy. Common techniques for localization are: Observing the intraocular tumor and surrounding retina using ophthalmoscopy while at the same time indenting the sclera with a small handheld instrument (indentor). This allows to identify the rim (borders) of the tumors which can then be marked on the sclera by a color pen. According to the marking the plaque is fixated on the sclera. Another technique of tumor localization is the so called diaphanoscopy where the outer surface of the sclera is observed by the surgeon while the inner structures of the eye are illuminated by a light fiber placed onto the cornea. The thick mass of an intraocular tumor prevents the light to shine through the sclera so that the basis of the tumor appears as a dark area on the outer sclera whereas the sclera outsides the surrounding sclera is brightened by the illumination. This allows the surgeon to mark the basis of the tumor on the sclera.
In Fig. 1 a side view is shown of an illuminated localization device according to an embodiment of the present invention. The illuminated localization device comprises a holder body 2 allowing the user to control the orientation of an optical assembly 3 extending from the holder body 2. The optical assembly 3 comprises an optical radiation conductor 5, and a surrounding sleeve 3a, 3b of a shape retaining material (see also the cross sectional views of Fig. 4 and 5 and the description thereof below). The optical assembly 3 has a straight part 3a and a ring shaped part 3b, the ring shaped part 3b being positioned remote from the holder body 2 and having a main ring surface 7. The ring shaped part 3b comprises a plurality of light exit apertures 4 for directing light exiting from the apertures 4 (substantially) normal to the main ring surface 7.
The optical radiation conductor 5 is implemented as an optical fiber in a further embodiment. The optical fiber is e.g. a glass fiber, a plastic fiber, etc. which allows a proper guidance of light energy towards the light exit apertures 4.
The surrounding sleeve 3a, 3b is made of a metal, such as (medical grade) stainless steel or of a plastic material. This allows to shape the optical assembly 3 correctly for its intended use during manufacturing and to keep that shape also during actual use. By correctly selecting the thickness and type of material, it would even be possible to make small alterations in the specific shape of the optical assembly prior or during actual use.
In a further embodiment, the plurality of light apertures 4 comprises at least three apertures 4, e.g. six as shown in the embodiment of Fig. 1. By placing the device onto the sclera the light from the apertures illuminates the sclera punctually. These light points (or spots) can be easily identified by the surgeon from the inner aspect of the eye using ophthalmoscopy. In case the light points, however, are placed onto the sclera underlying a tumor the mass of the tumor prevents the visibility of the light points. By moving the device to all sides on the sclera and observing the light points during ophthalmoscopy the surgeon has to find a position of the device where all light points encircle the tumor. In case one or more light points are not visible on the eyes internal eye (retina) they are occluded by the tumor mass and repositioning of the device is needed. Once all light points are clearly visible at the outer border of the tumor the surgeon marks the location of the ring on the outer sclera, e.g. using a color pen.
The illuminated localization device may further comprise a light source 8 connectable to the optical radiation conductor 5. The light source 8 may be integrated in the holder body 2 (even including a power source such as batteries), or the light source 8 may be positioned external to the holder body, as shown in the embodiment of Fig. 1. The optical radiation is then transferred to the optical radiation conductor 5 via an optical cable 2a.
Fig. 2 shows a partial view of the illuminated localization device of Fig. 1 during an actual us thereof. Actual use of the illuminated localization device comprises positioning the ring shaped part 3b of the illuminated localization device in contact with (or near to) a patient’s eye 10, with the light apertures 4 directed towards the eye 10, i.e. substantially normal to a main surface of the ring shaped part 3b. The user can then observe light points emanating from the light apertures 4 inside the eye 10 (via the eye’s lens), and scan an entire eye wall (sclera, choroid and retina) for possible presence of tumorous tissue by repositioning the illuminated localization device. The method further comprises positioning the ring shaped part 3b around an eye tissue part to be treated by brachytherapy, and attaching a brachytherapy plaque to cover the eye tissue part to be treated (e.g. using sutures). As the apertures 4 emit very specific spots of light, which are perfectly visible on the eye’s internal wall (retina), the proper position of tumorous tissue can be located very easily and accurately.
Fig. 3 shows an enlarged view of a ring shaped part 3b of a further embodiment of the illuminated localization device (with also a part of the straight part 3a still visible). The light exit apertures 4 are positioned to direct light away from the ring shaped part, i.e. out of the planar surface of the ring shaped part 3b. Fig. 4 shows a cross sectional view along the line IV-IV in Fig. 3, showing the optical radiation conductor 5 (optical fiber), surrounded by the ring shaped part 3b of the surrounding sleeve 3a, 3b. Also, the main ring surface 7 is indicated in this cross sectional view, and the orientation of the light exit aperture 4 (i.e. normal to the planar main ring surface 7 of the ring shaped part 3b). Also shown in this embodiment is that the light exit aperture 4 extends into the optical radiation conductor 5, with an indentation 5a. This embodiment ensures a proper manner of coupling light out of the optical radiation conductor 5 into a direction out of the light exit aperture 4. By properly dimensioning the diameters of the optical radiation conductor 5, sleeve 3a, 3b, the dimensions and shape of the light exit apertures 4, and the indentations 5a, it is possible to obtain sufficient and uniform light exiting the illuminated localization device form all light exit apertures 4, in a direction generally perpendicular to the main ring surface 7.
Furthermore, Fig. 3 shows an embodiment, wherein the ring shaped part 3b further comprises a plurality of marker elements 6 extending in a direction normal to the main ring surface 7. Fig. 5 shows a cross sectional view of the ring shaped part 3b at a positioned where such a marker element 6 is present. These marker elements 6 allow to make a visible mark in the sclera by pressing the illuminated localization device onto the eye 10, which remains there for a time period sufficient for performing a marking with a color pen. The method thus may further comprise exerting pressure to the illuminated localization device, removing the illuminated localization device, and attaching the brachytherapy plaque with sutures at the position of the sclera indicated by the impressions made by the marker elements 6. Using this embodiment of the present invention illuminated localization device, the user can thus take out the illuminated localization device, freeing up a hand for other procedural steps in the eye treatment.
In a further embodiment, each of the plurality of marker elements 6 is a blunt shaped part attached to the ring shaped part 3b. The shape of the marker element 6 may be a pyramid (see cross sectional view of Fig. 5), or as an alternative may be a truncated cone, a cylinder shape, a bullet point shape, etc. These shapes allow for a proper impression of the sclera which will remain visible at the inside surface of the eye (retina) for a period long enough to allow for further procedural steps e.g. in eye surgery.
The plurality of marker elements 6 comprises at least two marker elements 6. This would allow to indicate exactly the minimum of two suture positions for an iridium disc used in a brachytherapy procedure.
In view of the above description of exemplary embodiments the present invention can be summarized as a number of interdependent embodiments, defined as follows:
Embodiment 1. Illuminated localization device, comprising a holder body (2), an optical assembly (3) extending from the holder body (2) and comprising an optical radiation conductor (5) and a surrounding sleeve (3a, 3b) of a shape retaining material, the optical assembly (3) having a straight part (3a) and a ring shaped part (3b), the ring shaped part (3b) being positioned remote from the holder body (2) and having a main ring surface (7), the ring shaped part (3b) comprising a plurality of light exit apertures (4) directed normal to the main ring surface (7).
Embodiment 2. Illuminated localization device according to embodiment 1, wherein the light exit apertures (4) extend into the optical radiation conductor (5). Embodiment 3. Illuminated localization device according to embodiment 1 or 2, wherein the optical radiation conductor (5) is an optical fiber.
Embodiment 4. Illuminated localization device according to any one of embodiments 1-3, wherein the sleeve (3 a, 3b) is made of a metal, such as stainless steel.
Embodiment 5. Illuminated localization device according to any one of embodiments 1-4, wherein the plurality of light exit apertures (4) comprises at least three apertures (4), e.g. five.
Embodiment 6. Illuminated localization device according to any one of embodiments 1-5, further comprising a light source (8) connectable to the optical radiation conductor (5).
Embodiment 7. Illuminated localization device according to any one of embodiments 1-6, wherein the ring shaped part (3b) further comprises a plurality of marker elements (6) extending in a direction normal to the main ring surface (7). Embodiment 8. Illuminated localization device according to embodiment 7, wherein each of the plurality of marker elements (6) is a blunt shaped part attached to the ring shaped part (3b).
Embodiment 9. Illuminated localization device according to embodiment 7 or 8, wherein the plurality of marker elements (6) comprises at least two marker elements (6).
Embodiment 10 Method of using an illuminated localization device according to any one of embodiments 1-9, comprising positioning the ring shaped part (3b) of the illuminated localization device in contact with a patient’s eye (10), with the light exit apertures (4) directed to the eye (10), observing light points from the light exit apertures (4) inside the eye (10), positioning the ring shaped part (3b) around an eye tissue part to be treated by brachytherapy, and attaching a brachytherapy plaque to cover the eye tissue part to be treated.
Embodiment 11. Method according to embodiment 10, wherein the illuminated localization device is a device according to any one of embodiments 7-9, the method further comprising exerting pressure to the illuminated localization device, removing the illuminated localization device, attaching the brachytherapy plaque with sutures at the position of the sclera as indicated by the impressions made by the marker elements (6).
The present invention embodiments have been described above with reference to a number of exemplary embodiments as shown in the drawings. Modifications and alternative implementations of some parts or elements are possible, and are included in the scope of protection as defined in the appended claims.

Claims (11)

1. Verlichte lokalisatie inrichting, omvattende een houderlichaam (2), een optisch samenstel (3) dat uitsteekt vanuit het houderlichaam (2) en een optische straling geleider (5) en een omgevende mantel (3a, 3b) van een vormbehoudend materiaal omvat, waarbij het optisch samenstel (3) een recht gedeelte (3 a) en een ringvormig gedeelte (3b) heeft, het ringvormig gedeelte (3b) is gepositioneerd op afstand van het houderlichaam (2) en een hoofdringoppervlak (7) heeft, en het ringvormig gedeelte (3b) een veelvoud lichtuittreeopeningen (4) omvat die loodrecht zijn uitgericht top het hoofdringoppervlak (7).An illuminated locating device comprising a holder body (2), an optical assembly (3) protruding from the holder body (2) and an optical radiation conductor (5) and a surrounding sheath (3a, 3b) of a shape-retaining material, wherein the optical assembly (3) has a straight portion (3a) and an annular portion (3b), the annular portion (3b) is positioned at a distance from the container body (2) and has a main ring surface (7), and the annular portion portion (3b) includes a plurality of light exit openings (4) that are perpendicular to the main ring surface (7). 2. Verlichte lokalisatie inrichting volgens conclusie 1, waarbij de lichtuittreeopeningen (4) zicht uitstrekken in de optische straling geleider (5).Illuminated location device according to claim 1, wherein the light exit openings (4) extend into the optical radiation guide (5). 3. Verlichte lokalisatie inrichting volgens conclusie 1 of 2, waarbij de optische-straling geleider (5) een optische vezel is.Illuminated localization device according to claim 1 or 2, wherein the optical radiation conductor (5) is an optical fiber. 4. Verlichte lokalisatie inrichting volgens één van de conclusies 1-3, waarbij de mantel (3a, 3b) vervaardigd is van een metaal, zoals roestvrij staal.The illuminated location device according to any of claims 1-3, wherein the sheath (3a, 3b) is made of a metal, such as stainless steel. 5. Verlichte lokalisatie inrichting volgens één van de conclusies 1-4, waarbij het veelvoud lichtuittreeopeningen (4) ten minste drie openingen (4) omvat, bijvoorbeeld vijf.Illuminated locating device according to any of claims 1-4, wherein the plurality of light exit openings (4) comprises at least three openings (4), for example five. 6. Verlichte lokalisatie inrichting volgens één van de conclusies 1-5, verder omvattende een lichtbron (8) die te verbinden is met de optische-straling geleider (5).Illuminated localization device according to any of claims 1-5, further comprising a light source (8) connectable to the optical radiation conductor (5). 7. Verlichte lokalisatie inrichting volgens één van de conclusies 1-6, waarbij het ringvormig gedeelte (3b) verder een veelvoud markeerelementen (6) omvat die zich uitstrekken in een richting loodrecht op het hoofdringoppervlak (7).The illuminated locating device of any one of claims 1-6, wherein the annular portion (3b) further comprises a plurality of marker elements (6) extending in a direction perpendicular to the main ring surface (7). 8. Verlichte lokalisatie inrichting volgens conclusie 7, waarbij elk van het veelvoud markeerelementen (6) een bot gevormd gedeelte is dat bevestigd is aan het ringvormig gedeelte (3b).The illuminated location device of claim 7, wherein each of the plurality of marker elements (6) is a bone-shaped portion attached to the annular portion (3b). 9. Verlichte lokalisatie inrichting volgens conclusie 7 of 8, waarbij het veelvoud markeerelementen (6) ten minste twee markeerelementen (6) omvat.The illuminated location device according to claim 7 or 8, wherein the plurality of marker elements (6) comprises at least two marker elements (6). 10 Werkwijze voor het gebruik van een verlichte lokalisatie inrichting volgens één van de conclusies 1-9, omvattende positioneren van het ringvormig gedeelte (3b) van de verlichte lokalisatie inrichting in contact met een oog (10) van een patiënt met de lichtuittreeopeningen (4) gericht naar het oog (10), observeren van lichtpunten van de lichtuittreeopeningen (4) binnen het oog (10), positioneren van het ringvormig gedeelte (3b) rond een weefselgedeelte van het oog dat behandeld dient te worden met brachytherapie, en bevestigen van een brachytherapieplak teneinde het weefselgedeelte van het oog te bedekken.Method for using an illuminated localization device according to any of claims 1-9, comprising positioning the annular portion (3b) of the illuminated localization device in contact with an eye (10) of a patient with the light exit openings (4) facing the eye (10), observing light points from the light exit openings (4) within the eye (10), positioning the annular portion (3b) around a tissue portion of the eye to be treated with brachytherapy, and attaching a brachytherapy slice to cover the tissue portion of the eye. 11. Werkwijze volgens conclusie 10, waarbij de verlichte lokalisatie inrichting een inrichting volgens één van de conclusies 7-9 is, waarbij de werkwijze verder omvat uitoefenen van druk op de verlichte lokalisatie inrichting, verwijderen van de verlichte lokalisatie inrichting, bevestigen van de brachytherapieplak met hechtingen op de positie van de sclera zoals aangegeven door de indrukken die gemaakt zijn door de markeerelementen (6).The method of claim 10, wherein the illuminated localization device is a device according to any of claims 7-9, wherein the method further comprises applying pressure to the illuminated localization device, removing the illuminated localization device, attaching the brachytherapy slice with sutures at the position of the sclera as indicated by the impressions made by the marker elements (6).
NL2016032A 2015-12-24 2015-12-24 Illuminated localization device for brachytherapy of intraocular tumors. NL2016032B1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5582608A (en) * 1995-04-11 1996-12-10 Brown; Alan W. Lamellar illumination apparatus for eye surgery
US6267752B1 (en) * 1999-08-05 2001-07-31 Medibell Medical Vision Technologies, Ltd. Multi-functional eyelid speculum
WO2011083358A1 (en) * 2010-01-11 2011-07-14 Eye Tech Care Device for treating an ocular pathology by applying doses of laser energy
US20140379054A1 (en) * 2013-06-25 2014-12-25 TECLens, LLC Apparatus for phototherapy of the eye

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5582608A (en) * 1995-04-11 1996-12-10 Brown; Alan W. Lamellar illumination apparatus for eye surgery
US6267752B1 (en) * 1999-08-05 2001-07-31 Medibell Medical Vision Technologies, Ltd. Multi-functional eyelid speculum
WO2011083358A1 (en) * 2010-01-11 2011-07-14 Eye Tech Care Device for treating an ocular pathology by applying doses of laser energy
US20140379054A1 (en) * 2013-06-25 2014-12-25 TECLens, LLC Apparatus for phototherapy of the eye

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