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Title:
A RETRIEVAL DEVICE FOR REMOVING AN ELEMENT FROM AN EYE AND METHOD OF RETRIEVAL
Document Type and Number:
WIPO Patent Application WO/2018/007859
Kind Code:
A1
Abstract:
A retrieval device for removing an element from an eye and a method of retrieval disclosed relates to the field of ophthalmology. The retrieval device and the method of retrieval are used to remove any element from within the eye. The device and the method do not make any complication to the structure of the eye. The retrieval device comprises a plurality of wires and a sheath. The plurality of wires is connected at an operative end thereof defining a blunt end. The sheath is configured to partially cover the plurality of wires. The sheath and the plurality of wires are movable relative to each other, thereby facilitating a formation of a retrieval basket at the blunt end. The size of the retrieval basket is varied by displacing the sheath over the plurality of wires as per the size of the element to be retrieved from the eye.

Inventors:
SRINIVASAN KARTHIK (IN)
Application Number:
PCT/IB2016/055034
Publication Date:
January 11, 2018
Filing Date:
August 24, 2016
Export Citation:
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Assignee:
SRINIVASAN KARTHIK (IN)
International Classes:
A61F9/00; A61B17/00; A61F9/009
Foreign References:
US9101342B22015-08-11
US6217589B12001-04-17
US20070016225A12007-01-18
US20120083793A12012-04-05
Attorney, Agent or Firm:
DEWAN, Mohan (IN)
Download PDF:
Claims:
A retrieval device for removing an element from an eye, said retrieval device comprising: a plurality of wires connected at an operative end thereof to define a blunt end; and a sheath defining a lumen and configured to partially cover said plurality of wires, said sheath and said plurality of wires being movable relative to each other, thereby facilitating a formation of a retrieval basket at said blunt end, wherein the size of said retrieval basket can be varied, in accordance with the size of the element to be retrieved from the eye, by displacing said sheath over said plurality of wires.

The retrieval device as claimed in claim 1 , wherein each of said plurality of wires is made of a kink-resistant super elastic metallic alloy.

The retrieval device as claimed in claim 2, wherein said kink-resistant super elastic metallic alloy is nickel titanium alloy.

The retrieval device as claimed in claim 1, wherein the number of wires in said plurality of wires is four.

The retrieval device as claimed in claim 1, wherein said plurality of wires has a cross sectional configuration selected from a group consisting of D-shape, B-shape, V-shape, and semi-circular shape.

The retrieval device as claimed in claim 1, wherein at least two adjacent wires of said plurality of wires are interconnected by a wire mesh to securely capture the element to be retrieved from the eye.

The retrieval device as claimed in claim 4, wherein said plurality of wires includes: a first set of wires and a second set of wires, wherein said first set and said second set of wires are defined by two wires which are spaced 180° apart with respect to each other, such that all the wires of said first set and said second set of wires are spaced 90° apart from each other, wherein said first set of wires is adapted to move in tandem with said second set of wires to facilitate the opening and closing of said retrieval basket, thereby allowing the capture and retrieval of the element from the eye.

8. The retrieval device as claimed in claim 1, wherein said lumen is configured to receive a fragmatome equipment and/or an endo-illumination probe.

9. A method for retrieving an element from an eye, said method comprising the following steps: introducing the distal end of a retrieval device in the eye such that said distal end abuts the eye; displacing a plurality of wires relative to a sheath of said retrieval device to configure a retrieval basket at said distal end; capturing the element in said retrieval basket; and displacing said retrieval device along with the element captured in said retrieval basket away from the eye.

10. The method as claimed in claim 9, which further includes the following steps: inserting a fragmatome equipment inside a lumen of a sheath of said retrieval device; advancing said fragmatome equipment proximal to the element captured within said retrieval basket; and emulsifying, using said fragmatome equipment, the element captured within said retrieval basket.

Description:
A RETRIEVAL DEVICE FOR REMOVING AN ELEMENT FROM AN EYE AND METHOD OF RETRIEVAL

FIELD

The present disclosure relates to the field of ophthalmology. Particularly, the present disclosure relates to the field of devices used for retrieval of elements from eyes.

DEFINITIONS As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicate otherwise.

Element - The term element refers to a dislocated lens, any part of a dislocated lens, any foreign element, or any biological element within the eye. The element may be located in the eye.

Fragmatome equipment - The term fragmatome equipment refers to a device which is used for fragmentation or emulsification of the elements present in the eye.

Endo-illumination probe - The term endo-illumination probe refers to a device used to provide light for illumination of a surgical operation inside the body. BACKGROUND

Conventionally, in the field of ophthalmology, retrieval devices are used to retrieve biological or foreign element from within an eye. Such elements include a lens or any metallic or non- metallic foreign element. Dislocated lens and/or any element thereof are removed from the eye by using the retrieval device, preferably fragmatome equipment. The fragmatome equipment is used to emulsify the dislocated lens and/or any element thereof. However, the fragmatome equipment is not suitable to remove any metallic or non-metallic foreign body from within the eye. To retrieve such metallic or non-metallic foreign body from within the eye, a retrieval magnet or a forceps is used. Therefore, there is felt a need of a retrieval device and method that can be used to remove a dislocated lens as well as any foreign body from the eye and that alleviates drawbacks of the aforementioned devices and the methods.

OBJECTS Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

An object of the present disclosure is to provide a retrieval device and a method that is used to remove a dislocated lens as well as any metallic or non-metallic foreign body from within the eye. Another object of the present disclosure is to provide a retrieval device and a method for removal of an element from an eye that effectively immobilizes a dislocated lens.

Yet another object of the present disclosure is to provide a retrieval device and a method for removal of an element from an eye that does not create any complication to the structure of an eye. Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY

The present disclosure envisages a retrieval device for removing an element from an eye. The retrieval device comprises a plurality of wires and a sheath. The plurality of wires is connected at an operative end thereof to define a blunt end. The sheath defines a lumen and is configured to partially cover the plurality of wires. The sheath and the plurality of wires are movable relative to each other, thereby facilitating a formation of a retrieval basket at the blunt end. The size of the retrieval basket is varied by displacing the sheath over the plurality of wires in accordance with the size of the element to be retrieved from the eye. Each of the plurality of wires is made of a kink-resistant super elastic metallic alloy. In an embodiment, the kink-resistant super elastic metallic alloy is nickel titanium alloy. In another embodiment, the number of wires in the plurality of wires is four. The plurality of wires includes a first set of wires and a second set of wires. The first set and the second set of wires are defined by two wires which are spaced 180° apart with respect to each other, such that all the wires of the first set and the second set of wires are spaced 90° apart from each other. The first set of wires is adapted to move in tandem with the second set of wires to facilitate the opening and closing of the retrieval basket, thereby allowing the capture and retrieval of the element from the eye. The plurality of wires has a cross sectional configuration selected from a group consisting of D-shape, B-shape, V-shape, and semi-circular shape. Further, at least two adjacent wires of the plurality of wires are interconnected by a wire mesh to securely capture the element that is to be retrieved from the eye. In another embodiment, the lumen is configured to receive fragmatome equipment and/or an endo-illumination probe. In an embodiment, the sheath is of a metallic or a non-metallic material. In yet another embodiment, the retrieval basket is of a metallic or a non-metallic material, wherein the metallic material includes steel and alloys of steel.

The present disclosure also envisages a method for retrieving an element from an eye.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING A retrieval device for removing an element from an eye and method of retrieval, of the present disclosure, will now be described with the help of the accompanying drawing, in which:

Figure 1 illustrates a conventional device, which is used to retrieve an element from within the eye, in a closed state; Figure 2 illustrates the conventional device of figure 1 in an open state;

Figure 3 illustrates a photographic view of a retrieval device, in accordance with an embodiment of the present disclosure;

Figure 4 illustrates a photographic view of the retrieval device of the figure 3 with captured element; Figure 5 illustrates another photographic view of the retrieval device of the figure 3 with captured element;

Figure 6 illustrates a schematic view of the retrieval device, in accordance with another embodiment of the present disclosure; Figure 7 illustrates a schematic view of the retrieval device, in accordance with still another embodiment of the present disclosure;

Figure 8 illustrates a schematic view of the retrieval device, in accordance with yet another embodiment of the present disclosure; Figure 9 illustrates a schematic view of the retrieval device, in accordance with still another embodiment of the present disclosure; and

Figure 10a, 10b, and 10c illustrates schematic views of the retrieval device, in accordance with yet another embodiment of the present disclosure.

LIST OF REFERRAL NUMERALS USED IN DRAWING AND DETAILED DESCRIPTION

100 - Conventional device

110 - Conventional sheath

120 - Conventional basket

200 - Retrieval device of the present disclosure 210 - Sheath

210a - Distal end of the sheath

220 - Plurality of wires

221 - Wire mesh

230 - Distal end of the plurality of wires 240 - Basket 250 - Element

260 - Fragmatome equipment 270 - Light source 280 - Angulation

DETAILED DESCRIPTION

Figure 1 illustrates a conventional device 100, which is used to retrieve an element from an eye, in a closed state. Figure 2 illustrates the conventional device 100 of figure 1 in an open state.

The conventional device 100 has a sheath 110 and a retrieval assembly in a form of a basket 120. The basket 120 is configured to move in and out of the sheath 110. When the basket 120 is within the sheath 110, the basket 120 follows a collapsed profile having a reduced diameter, as shown in figure 1. If the sheath 110 is retracted relative to the basket 120 or the basket 120 is forcibly moved beyond the end of the sheath 110, the basket 120 expands in such a way that the profile of the basket 120 has a larger diameter than the diameter of the basket 120 having the collapsed profile, as shown in figure 2. Such basket 120 of the conventional device 100 has a round or oval shaped profile. However, the conventional device 100 is unsuitable for retrieving an element from within the eye, especially a dislocated lens.

The present disclosure envisages a retrieval device and a method that is to be used to remove the dislocated lens as well as any metallic or non-metallic foreign body from within the eye. The retrieval device is configured to open in order to capture the element, and to release the captured element in extended state. The retrieval device is also configured to release the captured element while the retrieval device is still positioned within the eye.

The captured element may be a dislocated lens, any part of a dislocated lens, any foreign element, or any biological element within the eye. The element may be located in the anterior, the exterior or any other part of the eye.

In accordance with the present disclosure, the retrieval device comprises a plurality of wires and a sheath. The plurality of wires is connected at an operative end thereof to define a blunt end. The sheath defines a lumen, and is configured to partially cover the plurality of wires. The sheath and the plurality of wires are movable relative to each other, thereby facilitating a formation of a retrieval basket at the blunt end. The size of the retrieval basket is varied by displacing the sheath over the plurality of wires in accordance with the size of the element to be retrieved from the eye. Different embodiments of the retrieval device, of the present disclosure, are now elaborately described with reference to figure 3 through figure 10c.

Figure 3 illustrates a photographic view of a retrieval device 200, in accordance with an embodiment of the present disclosure. Figure 4 illustrates a photographic view of the retrieval device 200 of the figure 3 with captured element 250. Figure 5 illustrates another photographic view of the retrieval device 200 of the figure 3 with captured element 250.

The retrieval device 200 comprises a plurality of wires 220 that are partially covered by a sheath 210. The plurality of wires 220 extends from an operative distal end 210a of the sheath 210. In an embodiment, each of the plurality of wires 220 is made of kink-resistant super elastic metallic alloy, which exhibits a super elastic property when maintained at a transformation temperature thereof. The transformation temperature of the plurality of wires 220 is kept below the normal operating temperature of the plurality of wires 220 to maintain the plurality of wires 220 in a super elastic state. In such a state, the plurality of wires 220 advantageously returns to their original shape when a deformation stress is removed from the plurality of wires 220. The plurality of wires 220 also increasingly resists the deformation as the stress load is increased. In an embodiment, the sheath is of a metallic or a non-metallic material.

Each of the plurality of wires 220 is made of a kink-resistant super elastic metallic alloy. In an embodiment, each of the plurality of wires 220 is defined by a single strand of the kink- resistant super elastic metallic alloy. In another embodiment, each of the plurality of wires 220 is made of a plurality of strands of a kink-resistant super elastic metallic alloy.

In a preferred embodiment, each of the plurality of wires 220 is made of nickel titanium, alloy also known as nitinol. When the plurality of wires 220, made up of nitinol, is operated below the transformation temperature thereof, the plurality of wires 220 must be heated to return to its original shape. Advantageously, the operating temperature of the plurality of wires 220, of the present disclosure, is above its transformation temperature to resist kinking and to return to its original shape without the application of any heat thereto.

The plurality of wires 220 is configured such that the plurality of wires 220 forms a basket (also interchangeably referred to as the retrieval basket) 240 at the distal portion thereof having a bulbous shape to effectively capture the lens, the foreign bodies, or any other element within the eye. In an embodiment, the basket 240 has a round or pear like shape. More specifically, the retrieval device need not be only a basket but can also be conceived to be of any shape or design with the plurality of wires, e.g., the device can be half a basket or box shaped or any conceivable form to grasp or engulf the element. In an embodiment, the retrieval basket is of a metallic or a non-metallic material, wherein the metallic material includes steel and alloys of steel.

In an embodiment, the basket 240 is formed by the plurality of wires 220 such that the plurality of wires 220 is parallel, non-overlapping and non-intersecting with each other. In an exemplary embodiment, the plurality of wires 220 is closely spaced to each other, such that the maximum distance therebetween is 2 mm. In another embodiment, the basket 240 is formed by four wires. More specifically, the number of wires in the plurality of wires 220 is four.

The basket 240 has a zero-tip or tipless configuration. In an embodiment, the plurality of wires 220 has a cross sectional configuration selected from a group consisting of D-shape, B- shape, V-shape and semi-circular shape. The plurality of wires 220 terminate at an operative distal end 230, such that the operative distal end 230 of the plurality of wires 220 has a zero- tip configuration.

The method of retrieving the element from within the eye using the retrieval device 200 is now described with reference to figure 4 and figure 5.

Initially, the retrieval device 200 is introduced either into the posterior or anterior chamber of the eye such that the distal end of the retrieval device 200 abuts the eye. During the introduction, the plurality of wires 220 is completely enclosed within the sheath 210. When an element 250, that is to be retrieved, is approached, the method involves displacing the plurality of wires 220 relative to the sheath 210 to configure the retrieval basket 240. More specifically, the distal end 230 of the plurality of wires 220 is extended beyond the distal end 210a of the sheath 210 to form the retrieval basket 240. If a larger size of the basket 240 is required, the plurality of wires 220 is further extended beyond the distal end 210a of the sheath 210. The extended portion of the plurality of wires 220 forms a loop to capture the element 250 within the basket 240. The distal end 230 of the plurality of wires 220 is advanced directly over the element 250 to be retrieved, thereby parting the plurality of wires 220 from each other to form a bigger loop. The element enters the basket 240 via an opening created by parted plurality of wires 220 at the distal end 230 thereof. Subsequent to the aforementioned steps, the retrieval device 200, along with the element 250 captured within the retrieval basket 240, is displaced away from the eye.

In an embodiment, the retrieval device 200 captures the element 250 at the side thereof through or between the loops formed by the plurality of wires 220. The captured element 250 can be released from the retrieval device 200 by extending the proximal portion (not shown in figures) of the plurality of wires 220 beyond the distal end 210a of the sheath 210. The element 250 can then be emulsified within the basket 240. If the captured element 250 is required to be held within the basket 240, the sheath 210 is advanced near to the distal end 230 of the plurality of wires 220, thereby gripping the element 250 within the basket 240. At this stage, if required, fragmatome equipment is inserted into the lumen configured within the sheath 210 and advanced into the posterior or anterior chamber of the eye proximal to the element 250 to emulsify the element 250 that is firmly held within the basket 240. After emulsifying the element 250, the retrieval device 200 is removed from the eye.

In an embodiment, as shown in figure 6, at least two adjacent wires of the plurality of wires 220 are interconnected by a wire mesh 221 to securely capture the element that is to be retrieved from the eye. More specifically, the number of plurality of wires 220 forming the basket 240 on one side is attached to each other by multiple smaller branches of the nitinol alloy to cover l/4th area of the basket 240, thereby preventing the escape of the captured element 250 from the basket 240 and also facilitating the emulsification of the element 250 using the fragmatome equipment without dropping any part of the element 250 inside the posterior chamber of the eye.

In another embodiment, as shown in figure 7, the lumen inside the sheath 210 is constructed in such a way as to allow the passage of fragmatome equipment 260 therethrough to facilitate the emulsification of the element within the basket 240. In yet another embodiment, as shown in figure 8, the lumen inside the sheath 210 is constructed in such a way that an endo-illumination probe or light source 270 can be placed inside to allow illumination of the posterior segment of the eye to enable easy capture of the element 250 without the need for an extra port for the illumination probe.

In yet another embodiment, as shown in figure 9, the configuration of the sheath 210 encapsulating the plurality of wires 220 has an angulation 280 to aid in the capture of the element 250 through the anterior chamber route without compromising on the structural integrity of the anterior chamber of the eye.

In yet another embodiment, as shown in figure 10a, 10b, and 10c, the number of wires in the plurality of wires 220 is four. The plurality of wires 220 includes a first set of wires (not exclusively labelled in figures) and a second set of wires (not exclusively labelled in figures). The first set and the second set of wires are defined by two wires which are spaced 180° apart with respect to each other, such that all the wires of the first set and the second set of wires are spaced 90° apart from each other. The first set of wires is adapted to move in tandem with the second set of wires to facilitate the opening and closing of the retrieval basket 240, thereby allowing the capture and retrieval of the element from the eye. More specifically, the plurality of wires 220 forming the basket 240 is constructed in a way such that two wires placed at a fixed 180 degree angle, i.e. horizontally placed, which is capable of opening or closing in tandem with another set of 2 wires which are placed 90 degree away from the other wires whereby this part of the 2 wires placed 90 degree away will be able to rotate on its axis from an initial resting position of 180 degree with the other 2 wires and come to its final position from that place to 90 degrees away by turning a wheel that is placed at the proximal end of the sheath which is made for that particular process. Therefore, 2 wires will be able to rotate on its axis to reach 90 degrees angle away from its primary position, and open and close in tandem with the other 2 wires. Such arrangement is used to hold or to break or to snare the dislocated lens in the anterior chamber of the eye. Once all four wires are together in a collapsed state, the retrieval device 200 is inserted into the anterior chamber and all four wires are expanded around the lens encapsulating it at 180 axis and then the wheel at the proximal end of the sheath 210 is rotated to make 2 wires rotate at its axis to 90 degrees thereby ensnaring the lens. The lens can then be removed from the eye as a whole or by breaking into smaller pieces by ensnaring each piece.

The retrieval device 200 can retrieve a biological element, a foreign body, a metallic or non- metallic element from within the eye without any complications to the structure of the eye.

TECHNICAL ADVANCEMENTS

The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a retrieval device for removing an element from an eye and method of retrieval that: • is used to remove the dislocated lens as well as any metallic or non-metallic foreign body from within the eye;

• effectively immobilizes a dislocated lens; and

• does not make any complication to the structure of an eye. The foregoing disclosure has been described with reference to the accompanying embodiments which do not limit the scope and ambit of the disclosure. The description provided is purely by way of example and illustration.

The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. The use of the expression "at least" or "at least one" suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.

Any discussion of documents, acts, elements, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.

The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.

While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.