An illumination unit and methods

Abstract

The invention relates to a illumination unit for ophthalmic surgery, comprising a fiber having a distal end for entering the eye and a proximal end connectable to a light source. The illumination unit further comprises an annular shaped connector traversed by the fiber. Here, the annular shaped connector is provided with a coupling structure for coupling with a trocar module for ophthalmic surgery such that, in a coupled state, the fiber extends into the trocar module.

Description

[0001] Title: An illumination unit and methods

[0002] The invention relates to an illumination unit for ophthalmic surgery, comprising a fiber having a distal end for entering the eye and a proximal end connectable to a light source.

[0003] Such eye illumination units are known from practice and from patent publication NL 1 031 588 in the name of the applicant disclosing an illumination unit wherein the fiber is provided with a stop that is movable along its longitudinal axis so as to flexibly set an insertion part of the fiber to be inserted into the eye.

[0004] During eye surgery, a surgeon typically uses a variety of instruments to be inserted into the eye, preferably using the same or a limited number of surgery openings in the sclera of the eye. Inherently, an illumination unit and other surgery instruments are repeatedly inserted and removed, via the surgery opening, into and from the eye. As a consequence, a relative large number of instrument handling steps are performed by surgeon, apart from the proper surgery acts.

[0005] It also appears that fibers may be difficult to insert into the sclera. Thus, inserting the fibers properly needs a considerable amount of surgery skill. Also, undesirably, the fiber may pull out of the sclera undesirably as trocar modules, such as the module known from International Application W02022 / 075840, do not apply a lot of friction to the fiber.

[0006] Further, a pulling or pushing force needed for setting or adjusting a desired axial position of the instrument or fiber relative to the sclera may change during the surgery process as physical or physiological characteristics of the surgery opening may change.

[0007] It is an object of the invention to provide an illumination unit wherein the above mentioned disadvantages are counteracted. In particular, it is a further objection of the invention to provide an illumination unit that is more flexible in use. Thereto, according to an aspect of the invention, an illumination unit for ophthalmic surgery is provided, comprising a fiber having a distal end for entering the eye and a proximal end connectable to a light source, the illumination unit further comprising an annular shaped connector traversed by the fiber, wherein the annular shaped connector is provided with a coupling structure for coupling with a trocar module for ophthalmic surgery such that, in a coupled state, the fiber extends into the trocar module.

[0008] According to another aspect of the invention, an assembly for ophthalmic surgery is provided, the assembly comprising an annular shaped connector traversable by a fiber, wherein the annular shaped connector is provided with a coupling structure for coupling with a trocar module for ophthalmic surgery, wherein the annular shaped connector is further provided with a holding structure constructed and arranged to surround the fiber.

[0009] By coupling the illumination unit with a trocar unit, the illumination unit can be easily inserted and removed from the eye, while the trocar unit can further be used for inserting and removing further surgical instruments such as a laser unit, an infusion connector, a vitrectome, and a forceps, thereby improving flexibility of the illumination in use, reducing the number of instrument handling steps during surgery.

[0010] As a further advantage, a friction force exerted on the fiber can be set to remain constant during surgery, especially by providing the annular shaped connector with a holding structure surrounding the fiber. As the axial position of the fiber relative to the holding structure can be adjusted in a simple but precise manner, also the length of the fiber protruding into the eye can be set such that the illuminated light in the eye can be directed better to a desired location in the eye providing an adjustable chandelier.

[0011] The invention is at least partly based on the insight that the holding structure enables more precise directing, while surprisingly, precisely by virtue of the simple and controlled adjustability of the projecting part of the fiber, a desired safety is maintained.

[0012] In a preferred embodiment, the fiber is movable in a longitudinal direction through the holding structure upon exerting a pulling or pushing force exceeding a friction force value applied by the holding structure. Then, the axial position of the fiber can precisely be set, e.g. by gripping the fiber manually or by using a pair of tweezers.

[0013] The length of the protruding part of the fiber into the eye can be adjusted so that a distal end of the fiber can be moved closer to the location in the eye to be lighted, or further away from it. To this end, for instance before but also during insertion of the protruding part into the eye, the fiber can be moved through the holding structure of the annular shaped connector.

[0014] Preferably, the holding structure can be held in an outer casing of the annular shaped connector, either permanently or removably, e.g. either attached using a moulding process or inserted as a separate element.

[0015] Advantageously, the holding structure is made from a resilient material and prestressed by the outer casing to set a predefined friction force to the fiber.

[0016] Further advantageous embodiments according to the invention are described in the following claims.

[0017] It should be noted that the technical features described above or below may each on its own be embodied in an illumination unit or in a method, i.e. isolated from the context in which it is described, separate from other features, or in combination with only a number of the other features described in the context in which it is disclosed. Each of these features may further be combined with any other feature disclosed, in any combination.

[0018] The invention will be further elucidated on the basis of exemplary embodiments which are represented in the drawings. The exemplary embodiments are given by way of non-limitative illustration of the invention. In the drawings:

[0019] Fig. 1 shows a schematic view of an illumination unit according to the invention, in an uncoupled state;

[0020] Fig. 2 shows a schematic cross sectional view of the illumination unit shown in Fig. 1, in a coupled state wherein a distal end of a fiber protrudes by a first length;

[0021] Fig. 3 shows a schematic cross sectional view of the illumination unit shown in Fig. 1, in a coupled state wherein the distal end of the fiber protrudes by a second length;

[0022] Fig. 4 shows a schematic view of another illumination unit according to the invention, in a disassembled and uncoupled state;

[0023] Fig. 5 shows a schematic cross sectional view of the illumination unit shown in Fig. 4, in a coupled state;

[0024] Fig. 6 shows a flow chart of a method for connecting an illumination unit,

[0025] Fig. 7 shows a flow chart of a method for disconnecting an illumination unit, and

[0026] Fig. 8 shows a view of the illumination unit of Fig. 1 and a trocar module.

[0027] In the figures identical or corresponding parts are represented with the same reference numerals. The drawings are only schematic representations of embodiments of the invention, which are given by manner of non-limited examples.

[0028] Figure 1 shows a schematic view of an illumination unit 1 according to the invention, in an uncoupled state. The illumination unit 1 is provided with a fiber 2 having a distal end 3 and a proximal end 4 (see also Figure 8). The fiber has a longitudinal axis Li. During use of the illumination unit 1 the proximal end 4 is connected to a light source, while the distal end 3 enters the interior of the eye, for illumination during surgery.

[0029] The illumination unit 1 is further provided with an annular shaped connector 5 traversed by the fiber 2, wherein the annular shaped connector 5 has a coupling structure 6 for coupling with a trocar module 10 for ophthalmic surgery, also shown in Fig. 1, such that, in a coupled state of the annular shaped connector 5 and the trocar module 10, the fiber 2 extends into the trocar module 10, in particular such that a portion of the fiber 2 extends into the trocar module 10, the fiber 2 then partly or completely traversing the trocar module 10. In this regard it is noted that, in the coupled state, the distal end 3 of the fiber 2 may extend into the trocar module 10, or the distal end 3 of the fiber 2 may have been advanced further, such that the distal end 3 of the fiber 2 protrudes from the trocar module 10 outwardly e.g. inwardly into the interior of the eye, as explained in more detail below. It is noted that the term “annular” is to be understood as surrounding or enclosing e.g. with a circle-shaped or polygon-shaped contour.

[0030] The coupling structure 6 of the annular shaped connector 5 is provided with an annular shaped connector body 7 defining radially inwardly a cavity 8 for receiving at least a portion of a valve unit of the trocar module 10, in the coupled state, as explained in more detail below. In the shown embodiment, the connector body 7 is advantageously provided with openings 7a for improving a coupling force with the trocar module 10.

[0031] The trocar module 10 has a tubular shaped cannula 11 having a distal part 12 and a proximal part 13 that are preferably together formed as an integral element. The distal part 12 is arranged for insertion into the eye, through the eye’s sclera. The proximal part 13 of the tubular shaped cannula 11 is arranged for receiving a distal part of another ophthalmic surgery instrument, in a coupled state, such as a fluid connector e.g. an infusion connector, a vitrectome, a forceps, a laser unit or an illumination unit. The cannula 11 has a mainly constant diameter apart from the proximal part 13 of the tubular shaped cannula 11 having a double tapered contour tapering towards the cannula portion having a mainly constant diameter. However, as an alternative, the proximal part 13 of the tubular shaped cannula 11 has another contour, e.g. a single tapered contour.

[0032] Typically, the cannula 11 may have a wall thickness ranging from circa 0.04 mm to circa 0.05 mm.

[0033] In the shown embodiment, the proximal part 13 of the tubular shaped cannula 11 is arranged for receiving the fiber 2, during a coupling process.

[0034] The trocar module 10 also has a valve unit 15 arranged at the proximal part 13 of the cannula 11 for sealing the cannula 11 in an uncoupled state, and for sealingly surrounding the fiber 2 when received in the cannula 11, in the coupled state.

[0035] In the uncoupled state, the valve unit 15 seals the cannula 11, i.e. sealingly closes off the proximal part 13 of the tubular shaped cannula 11 to counteract fluid leakage flowing from the interior of the eye. Here, the valve unit 15 is integrally formed, having an annular shaped body that is open at a first axial end and sealingly closed at a second axial end, opposite to the first axial end. The sealingly closed axial end may include a multiple number of flanges that mutually overlap, are biased against each other and individually partially cover the proximal part of the tubular shaped cannula 11, as described in patent publication NL 2 026 624.

[0036] Preferably, the valve unit 15 is removable, e.g. for enabling irrigation fluid or silicone oil to flow outwardly from the eye during specific surgery conditions. However, the valve unit 15 may be permanently mounted to the tubular shaped cannula 11. In another embodiment, the valve unit 15 does not circumscribe the cannula 11, however sealingly closing off the proximal part 13 of the tubular shaped cannula 11. The valve unit 15 sealingly closes the cannula 11 when no instrument or fiber 2 is inserted into the cannula 11. Further, the valve unit 15 may minimize leakage when an instrument or fiber 2 is inserted into the cannula 11.

[0037] Further, the trocar module 10 is provided with a collar 16 arranged around the cannula 11 and provided, at its exterior side with a circumferential groove 17 for engaging the sclera so as to stabilize the collar’s position in the eye and for serving as an engaging structure that can be clamped by a forceps or another surgical instrument handling the trocar module 10. Alternatively, another collar 16, e.g. without circumferential groove, or another engaging structure can be applied.

[0038] In the shown embodiment, the tubular shaped cannula 11 has a mainly circular cylindrical shape being mainly rotationally symmetric with respect to its longitudinal axis L2. Also the valve unit 15 and the collar 16 are rotationally symmetric, concentric to the longitudinal axis L2.

[0039] The cannula 11 can e.g. be made from a metal or a metal alloy. Further, the valve unit 15 may be made from an elastic material such as a silicone material.

[0040] Figure 2 shows a schematic cross sectional view of the illumination unit 1 shown in Fig. 1, in a coupled state with the trocar module 10 wherein the distal end 3 of a fiber 2 protrudes by a first length dl. As shown, in the coupled state, the annular shaped connector body 7 of the coupling structure 6 of the annular shaped connector 5 defining radially inwardly the cavity 8 has received at least a portion of the valve unit 15 of the trocar module 10, thereby realizing a stable and reliable coupling, while, on the other hand, the fiber 2 can still be shifted along the longitudinal axis Li.

[0041] In the coupled state, shown in Fig. 2, the fiber 2 has entered the cannula 11 of the trocar module 10 such that the distal end 3 of the fiber 2 protrudes from the distal part 12 of the cannula 11 outwardly by a first length dl. Figure 3 shows a schematic cross sectional view of the illumination unit 1 shown in Fig. 1, in a coupled state with the trocar module 10 wherein the distal end of the fiber protrudes by a second length d2. Here, the fiber 2 has been advanced further through the trocar module 10 along the longitudinal axis Li in a distal direction D.

[0042] As especially shown in Figs. 2 and 3, the annular shaped connector is further provided with a holding structure 9 surrounding the fiber 2, such that the fiber 2 traverses said holding structure 9. In particular, the fiber 2 is movable in the longitudinal direction Li through the holding structure 9 upon exerting a pulling or pushing force in said longitudinal direction Li exceeding a friction force value applied by the holding structure 9. Then, when no or only a minor pulling or pushing force is exerted, the fiber 2 remains stationary in said holding structure 9. However, when a user exerts a pulling or pushing force that is large enough to exceed the threshold friction force value, the axial position of the fiber 2 in the holding structure 9 can advantageously be adopted as desired.

[0043] As shown, an assembly for ophthalmic surgery is provided, the assembly comprising an annular shaped connector 5 traversable by a fiber 2, wherein the annular shaped connector 5 is provided with a coupling structure 6 for coupling with a trocar module 10 for ophthalmic surgery, wherein the annular shaped connector 5 is further provided with a holding structure 9 constructed and arranged to surround the fiber 2.

[0044] In the shown embodiment, the annular shaped connector 5 has an outer casing 9’ such that the holding structure 9 is permanently or removably received in the outer casing 9’. The outer casing 9’ may be integrally formed with the annular shaped connector body 7 of the connector 5, or may be mounted thereon, preferably axially aligned with said connector body 7. In a first embodiment, shown in Figs. 1-3, the holding structure 9 is attached to the outer casing 9’, e.g. using a 2k moulding process or another moulding process.

[0045] In a second embodiment, shown in Figs. 4-5, the holding structure 9 is formed as a separate holding element or so-called H-ring received in the outer casing 9’, e.g. such that due to geometry and dimensions the holding element 9 is locked in said outer casing 9’.

[0046] The holding structure or holding element 9 can be made from a resilient material such as a thermoplastic elastomer or other elastic material, preferably a silicone or polysiloxane material, a rubber material, or a polyvinyl chloride material, as described e.g. in https: / / en.wikipedia.org / wiki / Silicone. The materials are typically colorless oils or rubber-like substances. Silicones are typically used in sealants, adhesives, lubricants, medicine, cooking utensils, thermal insulation, and electrical insulation. Some common forms include silicone oil, grease, rubber, resin, and caulk. Advantageously, the holding structure 9 can be prestressed by the outer casing 9’ of the annular shaped connector 5 so as to exert a stationary friction force on the fiber 2 traversing the holding structure 9.

[0047] In the shown embodiment, the holding structure 9 is provided with a central passage 9a that is traversed by the fiber 2. The central passage 9a may be located concentrically with respect to the radial outer contour of the holding structure 9. Typically, the diameter of the central passage 9a in the prestressed holding structure 9 can be circa 0.2 mm, for example, while the fiber 2 may have a diameter of circa 0.4 mm, for example, facilitating 25 gauge and 27 gauge dimensions. Generally, the fiber diameter is matched with the diameter of the central passage 9a, as well as with general dimensions of the holding structure 9, materials of the holding structure etc. so as to provide a desired friction force exerted on the fiber 2 as described above. Figure 4 shows a schematic view of another illumination unit 1 according to the invention, in a disassembled and uncoupled state. Here, the illumination unit 1 is decoupled from the trocar unit 10 while also the fiber 2 has been removed from the annular shaped connector 5. Further, the separate holding element or H-bridge 9 has been removed from the outer casing 9’.

[0048] Figure 5 shows a schematic cross sectional view of the illumination unit 1 shown in Fig. 4, in an assembled and coupled state. Here, the separate holding element or H-bridge 9 has been inserted into the outer casing 9’, while the fiber 2 now traverses said H-bridge 9, the cavity 8 defined by the annular shaped connector body 7 and the cannula 11 of the trocar unit 10 coupled to the annular shaped connector 5 of the illumination unit 1.

[0049] In the coupled state of the illumination unit 1, the fiber 2 may be set in a desired axial position relative to the holding element 9 so as to select a user selectable length of the fiber 2 protruding from the distal part 12 of the cannula 11 radiating an adjustable chandelier illumination bundle. Also, the axial position of the fiber 2 relative to the holding structure 9 can be adjusted during surgery thereby modifying the length of the fiber 2 protruding exterior from the distal part 12 of the cannula 11 into the eye such that the illuminated light in the eye can be directed better to a desired location in the eye providing an adjustable chandelier. The protruding fiber portion can be moved back and forth along the longitudinal axis Li.

[0050] Figure 8 shows a view of the illumination unit 1 of Fig. 1 and a trocar module 10. As shown, the fiber 2 has a distal end 3 and a proximal end 4. The distal end 3 of the fiber 2 is arranged for entering the interior of the eye, via the trocar module 10. The proximal end 4 of the fiber 2 is arranged for connection to a light source.

[0051] Figure 6 shows a flow chart of a method 100 according to the invention. The method is used for connecting an illumination unit to a trocar unit. The method 100 comprises a step of coupling 110 the coupling structure of the annular shaped connector with the valve unit of the trocar unit, and a step of advancing 120 the fiber through the holding structure of the annular shaped connector until the fiber extends into the cannula of the trocar unit.

[0052] The method 100 may further comprise a step of advancing the fiber further through the holding structure of the annular shaped connector until the fiber protrudes from the distal end of the cannula outwardly..

[0053] Figure 7 shows a flow chart of a method 200 according to the invention. The method is used for disconnecting an illumination unit from a trocar. The method 200 comprises a step of decoupling 210 the coupling structure of the annular shaped connector from the valve unit of the trocar unit.

[0054] The invention is not restricted to the embodiments described herein. It will be understood that many variants are possible.

[0055] It is noted that the trocar module described above can not only be used for coupling to an annular shaped connector, but also for being traversed by other ophthalmic surgical devices such as a laser device, a vitrectome, a forceps or a capillary tube of a fluid connector.

[0056] These and other embodiments will be apparent for the person skilled in the art and are considered to fall within the scope of the invention as defined in the following claims. For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments. However, it will be appreciated that the scope of the invention may include embodiments having combinations of all or some of the features described.

Claims

Claims1. An assembly for ophthalmic surgery, the assembly comprising an annular shaped connector traversable by a fiber, wherein the annular shaped connector is provided with a coupling structure for coupling with a trocar module for ophthalmic surgery, wherein the annular shaped connector is further provided with a holding structure constructed and arranged to surround the fiber.

2. An assembly according to claim 1, wherein the annular shaped connector has an outer casing and wherein the holding structure is permanently or removably received in the outer casing.

3. An assembly according to claim 1 or 2, wherein the holding structure is formed as a holding element received in the outer casing.

4. An assembly according to claim 1, 2 or 3, wherein the holding structure is made from a resilient material such as a thermoplastic elastomer or other elastic material, preferably silicone, a rubber material, or a polyvinyl chloride material.

5. An illumination unit for ophthalmic surgery including an assembly according to any of the preceding claims 1-4, wherein the fiber has a distal end for entering the eye and a proximal end connectable to a light source, wherein the annular shaped connector is traversed by the fiber, and wherein, in a coupled state, the fiber extends into the trocar module.

6. An illumination unit according to claim 5, wherein the annular shaped connector is further provided with a holding structure surrounding the fiber.

7. An illumination unit according to claim 6, wherein the fiber is movable in a longitudinal direction through the holding structure upon exerting a pulling or pushing force exceeding a friction force value applied by the holding structure.

8. An illumination unit according to claim 6 or 7, wherein the annular shaped connector has an outer casing and wherein the holding structure is permanently or removably received in the outer casing.

9. An illumination unit according to claim 8, wherein the holding structure is attached to the outer casing using a molding process.

10. An illumination unit according to claim 9, wherein the holding structure is formed as a holding element received in the outer casing.

11. An illumination unit according to any of claims 5 to 10, wherein the holding structure is made from a resilient material such as a thermoplastic elastomer or other elastic material, preferably silicone, a rubber material, or a polyvinyl chloride material.

12. An illumination unit according to any of claims 5 to 11, wherein the holding structure is prestressed by the outer casing of the annular shaped connector.

13. An illumination unit according to any of claims 5 to 12, wherein the holding structure is provided with a central passage traversed by the fiber.

14. An illumination unit according to any of claims 5 to 13, wherein the trocar module includes a tubular shaped cannula having a distal part for insertion through the eye’s sclera and a proximal part for receiving the fiber, in the coupled state, with said the annular shaped connector of the illumination unit, and wherein the trocar module further includes a valve unit arranged at the proximal part of the cannula for sealing said cannula in an uncoupled state.

15. An illumination unit according to any of claims 5 to 14, wherein the coupling structure of the annular shaped connector is provided with an annular shaped connector body defining radially inwardly a cavity for receiving at least a portion of the valve unit of the trocar module, in the coupled state.

16. A method for connecting an illumination unit according to claim 14 or 15 to a trocar unit, the method comprising the steps of:- coupling the coupling structure of the annular shaped connector with the valve unit of the trocar unit, and- advancing the fiber through the holding structure of the annular shaped connector until the fiber extends into the cannula of the trocar unit.

17. A method according to claim 16, further comprising a step of advancing the fiber further through the holding structure of the annular shaped connector until the fiber protrudes from the distal end of the cannula outwardly.

18. A method for disconnecting an illumination unit according to claim 14 or 15 from the trocar, the method comprising the step of decoupling the coupling structure of the annular shaped connector from the valve unit of the trocar unit.

Images