Patent Application
20160074054
The present invention relates generally to iris retractor assemblies used in ophthalmic surgical procedures, and particularly to a forceps for grasping an iris retractor.
There are various ophthalmic procedures that require the dilation of the pupil. For example, a lens with a cataract is typically removed from the eye by phacoemulsification. This procedure breaks up the lens typically with an ultrasonically driven tool. The tool has an aspiration port that aspirates the broken lens material from the patient's ocular-chamber. It is desirable to extend the pupil during phacoemulsification to provide the surgeon with a wide view of the lens. One technique for extending the pupil includes pulling back or retracting the iris with what is referred to as an iris retractor, and holding the iris at its outer edges.
PCT Patent Application WO/2011/053945 (PCT/US2010/055026) of the present assignee describes an iris retractor that has iris grabbing hooks disposed or formed at a distal end of slender elements. A proximal handle is at a proximal end of the slender elements. The slender elements rigidily or resiliently move between retracted and expanded positions by manipulation of the slender elements. In the retracted position, the hooks are close to one another and the slender elements are close to one another. In the expanded position, the hooks are separate and spaced apart from each other and the slender elements are separate and spaced apart from each other. The surgeon inserts the slender elements in the retracted position through a small incision near the limbus of the eye, manipulates the handle to move the slender elements to the expanded position, and grasps and retracts a portion of the iris with the hooks. The incisions for the insertion of the slender elements is made at different positions than the incision for phacoemulsification.
PCT Patent Application PCT/US2012/061513 of the present assignee describes further iris retractor assemblies. In one example, pincer interface members are located at proximal ends of the slender elements. The pincer interface members include posts that jut out of the proximal ends perpendicular to a plane of the slender elements and parallel to a pivot axis of the pivot member.
The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.
The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.
In one embodiment,the invention provides an assembly comprising: an iris retractor forceps comprising two forceps legs which join together at a proximal junction, the forceps legs comprising distal graspers for grasping an iris retractor or a holder for an iris retractor; and a locking element slidingly received in an elongated channel (or alternatively at least two grooves: distal and proximal) formed in the forceps legs, the locking element sliding between at least two positions, the at least two positions comprising: (a) a first position in which the forceps legs are spread apart, and (b) a second position in which the forceps legs are squeezed together, wherein in the second position the locking element is held in a locked position.
In one embodiment, the invention further provides a kit comprising: one or more iris retractor assemblies; a holder comprising one or more iris retractor assemblies or holding assemblies (the holding assemblies are configured to hold one or more iris retractor assemblies); an iris retractor forceps comprising two forceps legs which join together at a proximal junction, the forceps legs comprising distal graspers for grasping the holder; and a locking element slidingly received in an elongated channel (or alternatively at least two grooves) formed in the forceps legs, the locking element sliding between at least two positions, the at least two positions comprising: (a) a first position in which the forceps legs are spread apart, and (b) a second position in which the forceps legs are squeezed together, wherein in the second position the locking element is held in a locked position.
In one embodiment, the invention further provides a kit comprising: one or more iris retractor assemblies; an iris retractor forceps comprising two forceps legs which join together at a proximal junction, the forceps legs comprising distal curved grasping tips for grasping an iris retractor assembly of the one or more iris retractor assemblies; and a locking element slidingly received in an elongated channel (or alternatively at least two grooves) formed in the forceps legs, the locking element sliding between at least two positions, the at least two positions comprising: (a) a first position in which the forceps legs are spread apart, and (b) a second position in which the forceps legs are squeezed together,wherein in the second position the locking element is held in a locked position. In one embodiment, at least grooves define a first position in which the forceps legs are spread apart, and a second position in which the forceps legs are squeezed together.
In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description.
Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.
Kits, assemblies and forceps devices for ophthalmic surgical procedures are disclosed herein. Iris retractor forceps (or simply “forceps”) for grasping and holding iris retractor assemblies or a holder for such iris retractor assemblies, as described in more detail herein below, may be used with a locking element to hold an iris retractor assembly (or simply “iris retractor” or “retractor”). The locking element may enable the forceps to hold a loaded iris retractor, such as when the retractor is not yet in use or when passing the retractor from one person to another. The locking element may, in some embodiments, lock the iris retractor to the forceps. For example, loaded forceps may be left loaded and locked on the sterile table for the physician's use.
Reference is now made to
Iris retractor forceps 10 includes two forceps legs 12 which join together at a proximal junction 14 (
Each of the forceps legs 12 may be formed with grooves 32 and/or 34 one proximal and one distal, into which a flexible member 38 of locking element 30 may be slidingly received. In another embodiment, elongated channel may be formed with two or more grooves, for example grooves 32 and 34, one proximal and one distal. In one embodiment, no elongated channel is present and at least grooves (one proximal and one distal) define a first position in which the forceps legs are spread apart, and a second position in which the forceps legs are squeezed together.
In another embodiment, a locking element is slidingly received in a groove formed in the forceps legs, wherein the locking element is sliding between at least two positions: a distal position and a proximal position. In another embodiment, a locking element is slidingly received in a distal groove or a proximal groove formed in the forceps legs, wherein the locking element is slides between a distal position defined by a distal groove and a proximal position defined by a proximal groove. In some embodiments, the phrase “a distal groove and a proximal groove formed in the forceps legs” includes parallel distal grooves in each forceps leg and parallel proximal grooves in each forceps leg. In some embodiments, the phrase “a distal groove and a proximal groove formed in the forceps legs” includes a single distal groove in one of the forceps leg and a single proximal groove in the same leg. In some embodiments, the phrase “a distal groove and a proximal groove formed in the forceps legs” includes a distal groove and a proximal groove in one leg. In some embodiments, the phrase “a distal groove and a proximal groove formed in the forceps legs” includes a distal groove and a proximal groove formed in each one of the forceps leg.
In another embodiment, locking element 30 may include two pieces which mate with each other when assembled in a groove. In another embodiment, locking element 30 may include an inner rib 36 with a bulging flexible member 38. The flexible member 38 locks (“clicks”) into grooves 32 or 34.
Referring to
Referring to
Referring to
Reference is now made to
In the illustrated embodiment, holder 40 may include a base 44 on which one or more iris retractor assemblies 46 (typically a pair of iris retractors) may be positioned.
Holding assembly 46 includes two blocks 48, each formed with a groove 50. When the iris retractor 42 is held in iris retractor holding assembly 46, its slender elements 43 rest against opposing grooves 50, as seen in
The locking element 30 enables forceps 10 to hold a loaded iris retractor, without the need of holding the forceps contracted by hand, such as when the retractor is not yet in use or when passing the retractor from one person to another, or when the retractor is loaded by the assistant for postponed use. Loaded forceps may be left loaded and locked on the sterile table for postponed physician's use
Forceps 10 may be adapted to grasp iris retractor assemblies by utilizing grasping mechanisms as disclosed in WO 2013/062983. An exemplary mechanism for holding an exemplary iris retractor, as shown in
In some embodiment, a pair of iris retractors as described herein are used in kits and in medical procedures as described herein. In another embodiment, the forceps of the invention are adapted to grasp a single iris retractor in a non-expanded orientation (i.e., retracted position) and then used for placing each iris retractor in the eye. In another embodiment, adapted to grasp includes a structure for securing an iris retractor within the forceps which allows the insertion of an iris retractor in a retracted position through a small incision in the limbus. In another embodiment, the small incision is 0.5 to 2.5 mm wide. In another embodiment, the small incision is 0.7 to 1.8 mm wide. In another embodiment, the small incision is 0.8 to 1.6 mm wide. In another embodiment, the small incision is 1.0 to 1.5 mm wide.
In another embodiment, the forceps and a pair of iris retractors are utilized in various ophthalmic procedures that require the dilation of the pupil. For example, a lens with a cataract is typically removed from the eye by phacoemulsification. In another embodiment, a pair of iris retractors are inserted into an affected eye with the forceps thus extending the pupil during phacoemulsification thereby providing the surgeon with a wide view of the lens. In another embodiment, extending the pupil is retracting the iris with what is referred to as an iris retractor, and holding the iris at its outer edges.
In another embodiment, the iris retractor forceps (also referred to as forceps) specifically fit, grasp and hold a single iris retractor assembly via the retractor's handles (two handles for each iris retractor) or proximal forceps grasping means. In another embodiment, the forceps pull out a single iris retractor from its housing. In another embodiment, the forceps are used to pull out a single iris retractor from a holding assembly comprising or consisting at least one iris retractor assembly. In another embodiment, the forceps are used to pull out a single iris retractor from a holding assembly comprising or consisting two iris retractor assemblies. In another embodiment, the forceps are used to pull out a single iris retractor from a holding assembly. In another embodiment, the iris retractor is the iris retractor described in PCT Patent Application Publication WO 2013/062983 which is hereby incorporated by reference in its entirety. In another embodiment, the iris retractor is secured or semi-secured to the forceps via one or more grasping tips located at the proximal ends of each handle of the iris retractor. In another embodiment, the iris retractor is secured or semi-secured to the forceps via two two protruding ears wherein each protruding ear is disposed at the proximal end of each one the two slender elements. In another embodiment, a holder (such as a housing) comprises one or more iris retractor holding assemblies wherein each iris retractor holding assembly is configured to hold one or more iris retractor assemblies. In another embodiment, a holder (such as a housing) comprises one or more iris retractor holding assemblies wherein each iris retractor holding assembly is configured to hold one iris retractor. In another embodiment, the holder (such as a housing) and iris retractor holding assembly maintain the one or more iris retractors, sterile. In another embodiment, the holder (such as a housing) and iris retractor holding assembly protect the one or more iris retractors from damage such as but not limited to physical damage, contamination, humidity, or any combination thereof.
Proximal ends 106 may be disposed or formed at a proximal end of one or more slender elements 102. Iris grabbing hooks 112 may be disposed or formed at a distal end of one or more slender elements 102. Slender elements 102 may be pivoted about pivot member 110. Protruding ears 108 may be disposed or formed at a proximal end of one or more slender elements 102 and at edges of proximal ends 106.
Slender elements 102 may be biased against each other by biasing member 104, such as a springy, resilient wire, band, leaf spring and the like, connected to proximal ends 106 of slender elements 102.
In usage, iris tissue may be held between distal tooth 116 and proximal tooth 114, wherein distal tooth 116 may be below the iris and proximal tooth 114 may be above the iris. In another embodiment, usage, iris tissue may be held between distal tooth 116 and proximal tooth 114, wherein proximal tooth 114 may be below the iris and distal tooth 116 may be above the iris.
Optionally, distal tooth 116 may curve outwardly (outwardly in the sense of outwards from an imaginary centerline that passes through pivot member 100 and the middle of biasing member 104) and proximal tooth 114 may be tilted towards distal tooth 116, as shown in the illustrated embodiment of
In some embodiments, distal tooth 116 may be a rounded protuberance, wider than the width of slender element 102. Proximal tooth 114 may curve slightly outwardly.
The double biasing member 104 may provide a balanced and centered (symmetric) spring force on slender elements 102 of iris retractor 100. In other words, the spring force may be symmetric about pivot member 110 and this may prevent retractor 100 from twisting or bending due to asymmetric spring forces. For example, this may enable use of plastics to make retractor 100, because of the reduced or negligible spring forces on slender elements 102. In some embodiments, a biasing member which includes only one biasing element, as opposed to double biasing member 104, may be used.
Reference is now made to
In another embodiment, the phrases “iris retractor” and “iris retractor assembly” are used interchangebly.
In some embodiments, “a” is the maximal length of slender element 102 of iris retractor 100 (i.e., from protruding ear 108 to distal tooth 116). In some embodiments, “a” equals to 4.05 to 12.3 millimeters (mm). In some embodiments, “a” equals to 5.5 to 11 mm. In some embodiments, “a” equals to 7 to 9.5 mm. In some embodiments, “a” equals to 8 to 8.8 mm. In some embodiments, “a” equals to 8.1 to 8.3 mm. In some embodiments, “b” is the maximal length of slender element 102 of iris retractor 100 from pivot member 110 to distal tooth 116. In some embodiments, “b” equals to 2.55 to 7.8 mm. In some embodiments, “b” equals to 3 to 7 mm. In some embodiments, “b” equals to 3.5 to 6.5 mm. In some embodiments, “b” equals to 4.3 to 5.8 mm. In some embodiments, “b” equals to 5 to 5.4 mm.
In some embodiments, “c” is the minimal width of a portion of slender element 102 of iris retractor 100 extending from pivot member 110 to proximal tooth 114. In some embodiments, “c” equals to 0.19 to 0.63 mm. In some embodiments, “c” equals to 0.24 to 0.58 mm. In some embodiments, “c” equals to 0.29 to 0.53 mm. In some embodiments, “c” equals to 0.34 to 0.48 mm. In some embodiments, “c” equals to 0.38 to 0.43 mm.
In some embodiments, “d” is the distance between the inner edges of proximal teeth 114 of iris retractor 100. In some embodiments, “d”, when slender element 102 is in a maximal extended orientation, equals to 2.9 to 9.3 mm. In some embodiments, “d”, when slender element 102 is in a maximal extended orientation equals to 3.6 to 8.5 mm. In some embodiments, “d”, when slender element 102 is in a maximal extended orientation equals to 4.3 to 7.7 mm. In some embodiments, “d”, when slender element 102 is in a maximal extended orientation equals to 5.05 to 6.95 mm. In some embodiments, “d”, when slender element 102 is in a maximal extended orientation equals to 5.8 to 6.2 mm.
In some embodiments, “d”, when slender element 102 is in a maximal contracted orientation equals to 0.07 to 0.38 mm. In some embodiments, “d”, when slender element 102 is in a maximal contracted orientation equals to 0.11 to 0.34 mm. In some embodiments, “d”, when slender element 102 is in a maximal contracted orientation equals to 0.14 to 0.3 mm. In some embodiments, “d”, when slender element 102 is in a maximal contracted orientation equals to 0.16 to 0.27 mm. In some embodiments, “d”, when slender element 102 is in a maximal contracted orientation equals to 0.18 to 0.23 mm.
In some embodiments, “e” is the distance between a proximal edge of proximal end 106 and pivot member 110 of iris retractor 100. In some embodiments, “e”, when slender element 102 is in a maximal extended orientation, equals to 0.45 to 1.44 mm. In some embodiments, “e”, when slender element 102 is in a maximal extended orientation, equals to 0.55 to 1.34 mm. In some embodiments, “e”, when slender element 102 is in a maximal extended orientation, equals to 0.65 to 1.25 mm. In some embodiments, “e”, when slender element 102 is in a maximal extended orientation, equals to 0.75 to 1.15 mm. In some embodiments, “e”, when slender element 102 is in a maximal extended orientation, equals to 0.85 to 1.04 mm.
In some embodiments, “e”, when slender element 102 is in a maximal contracted orientation, equals to 1.47 to 4.56 mm. In some embodiments, “e”, when slender element 102 is in a maximal contracted orientation, equals to 1.87 to 4.15 mm. In some embodiments, “e”, when slender element 102 is in a maximal contracted orientation, equals to 2.2 to 3.75 mm. In some embodiments, “e”, when slender element 102 is in a maximal contracted orientation, equals to 2.6 to 3.4 mm. In some embodiments, “e”, when slender element 102 is in a maximal contracted orientation, equals to 2.8 to 3.3 mm. In some embodiments, “f” is the distance between pivot member 110 and a distal edge of distal tooth 116 of iris retractor 100. In some embodiments, “f” equals to 1.5 to 4.74 mm when slender element 102 is in a maximal extended orientation. In some embodiments, “f” equals to 1.9 to 4.3 mm when slender element 102 is in a maximal extended orientation. In some embodiments, “f” equals to 2.3 to 3 9 mm when slender element 102 is in a maximal extended orientation. In some embodiments, “f” equals to 2.7 to 3 5 mm when slender element 102 is in a maximal extended orientation. In some embodiments, “f” equals to 2.85 to 3.3 mm when slender element 102 is in a maximal extended orientation.
In some embodiments, “f” equals to 2.55 to 7 8 mm when slender element 102 is in a maximal contracted orientation. In some embodiments, “f” equals to 3.15 to 7 2 mm when slender element 102 is in a maximal contracted orientation. In some embodiments, “f” equals to 3.75 to 6.6 mm when slender element 102 is in a maximal contracted orientation. In some embodiments, “f” equals to 4.4 to 6 mm when slender element 102 is in a maximal contracted orientation. In some embodiments, “f” equals to 4.8 to 5 4 mm when slender element 102 is in a maximal contracted orientation.
In some embodiments, “g” is the maximal buldge of protruding ear 108 of iris retractor 100. In some embodiments, “g” equals to 0.13 to 0.5 mm. In some embodiments, “g” equals to 0.18 to 0.45 mm. In some embodiments, “g” equals to 0.23 to 0.4 mm. In some embodiments, “g” equals to 0.26 to 0.37 mm. In some embodiments, “g” equals to 0.28 to 0.33 mm.
In some embodiments, “h” is the maximal length of protruding ear 108 of iris retractor 100. In some embodiments, “h” equals to 0.22 to 0.83 mm. In some embodiments, “h” equals to 0.27 to 0.77 mm. In some embodiments, “h” equals to 0.32 to 0.71 mm. In some embodiments, “h” equals to 0.4 to 0.66 mm. In some embodiments, “h” equals to 0.45 to 0.58 mm. In some embodiments, “i” is the radius of Protruding ears 108. In some embodiments, “i” is 0.7 to 1.2 mm. In some embodiments, “i” is 0.8 to 1.1 mm. In some embodiments, “i” is 0.8 to 1.0 mm. In some embodiments, “i” is 0.86 to 0.9 mm.
Reference is now made to
In some embodiments, “j” is the depth or thickness of two slender elements 102 of retractor 100, as shown in
In some embodiments, “k” is the maximal depth or thickness of a middle portion of two slender elements 102 of retractor 100, as shown in
In some embodiments, “l” is the maximal depth or thickness of the upper slender element 102 (i.e., as held by a medical professional with respect to a treated iris) of two slender elements 102 of retractor 100, as shown in
In some embodiments, “m” is a depth or thickness of a middle portion of two slender elements 102 and the pivot member 110 heat formed top to connect the slender elements to each other of retractor 100, as shown in
In some embodiments, “n” is the maximal depth or thickness of protruding ear 108 of retractor 100, as shown in
In some embodiments, “o” equals to 0.8 to 2.7 mm. In some embodiments, “o” equals to 1.05 to 2.45 mm. In some embodiments, “o” equals to 1.3 to 2.2 mm. In some embodiments, “o” equals to 1.55 to 1.95 mm. In some embodiments, “o” equals to 1.65 to 1.75 mm.
Reference is now made to
In some embodiments, “p” is the length of the forceps. In some embodiments, “p” is between 60 to 200 mm. In some embodiments, “p” is between 80 to 150 mm. In some embodiments, “p” is between 90 to 120 mm. In some embodiments, “p” is between 110 to 115 mm. In some embodiments, “p” is between 112 to 113 mm.
In some embodiments, “q” is the maximal width of locking element 30. In some embodiments, “q” equals to 0.45 to 1.65 mm. In some embodiments, “q” equals to 0.6 to 1.5 mm. In some embodiments, “q” equals to 0.75 to 1.35 mm. In some embodiments, “q” equals to 0.85 to 1.2 mm. In some embodiments, “q” equals to 0.95 to 1.05 mm.
In some embodiments, “r” is the maximal width of forceps leg 12. In some embodiments, “r” equals to 0.26 to 1.01 mm. In some embodiments, “r” equals to 0.36 to 0.92 mm. In some embodiments, “r” equals to 0.46 to 0.82 mm. In some embodiments, “r” equals to 0.5 to 0.75 mm. In some embodiments, “r” equals to 0.58 to 1.65 mm.
In some embodiments, “s” is the maximal total length of locking element 30 and handle member 16. In some embodiments, “s” equals to 0.14 to 0.48 mm. In some embodiments, “s” equals to 0.17 to 0.45 mm. In some embodiments, “s” equals to 0.2 to 0.42 mm. In some embodiments, “s” equals to 0.23 to 0.38 mm. In some embodiments, “s” equals to 0.25 to 0.32 mm.
Reference is now made to
In some embodiments, “u” is the maximal width of notch 60. In some embodiments, “u” equals to 0.01 to 0.5 mm. In some embodiments, “u” equals to 0.06 to 0.45 mm. In some embodiments, “u” equals to 0.11 to 0.4 mm. In some embodiments, “u” equals to 0.2 to 0.35 mm. In some embodiments, “u” equals to 0.28 to 0.32 mm.
In some embodiments, “v” is the maximal length of distal curved grasping tip 22. In some embodiments, “v” equals to 0.8 to 2.7 mm. In some embodiments, “v” equals to 1.05 to 2.45 mm. In some embodiments, “v” equals to 1.3 to 2.2 mm. In some embodiments, “v” equals to 1.55 to 1.95 mm. In some embodiments, “v” equals to 1.65 to 1.75 mm.
Reference is now made to
In some embodiments, “w” is the distance between distal graspers 18. In some embodiments, “w” equals to 56 to 169.5 mm. In some embodiments, “w” equals to 70 to 165 mm when graspers 18 are in a maximal extended orientation. In some embodiments, “w” equals to 85 to 160 mm when graspers 18 are in a maximal extended orientation. In some embodiments, “w” equals to 95 to 145 mm when graspers 18 are in a maximal extended orientation. In some embodiments, “w” equals to 105 to 130 mm when graspers 18 are in a maximal extended orientation.
In some embodiments, “w” equals to 1 to 18 mm. In some embodiments, “w” equals to 2 to 5 mm when graspers 18 are in a maximal contracted orientation. In some embodiments, “w” equals to 2.5 to 4 5 mm when graspers 18 are in a maximal contracted orientation. In some embodiments, “w” equals to 2.2 to 4 mm when graspers 18 are in a maximal contracted orientation. In some embodiments, “w” equals to 8 to 18 mm when graspers 18 are in a maximal expanded orientation. In some embodiments, “w” equals to 10 to 16 mm when graspers 18 are in a maximal expanded orientation.
In some embodiments, “α” (or alpha) is the angle between forceps legs 12. In some embodiments, “α”(or alpha) equals to 5.75 to 17.55 degrees when forceps legs 12 are in a maximal extended orientation. In some embodiments, “α” (or alpha) equals to 7.25 to 16 degrees when forceps legs 12 are in a maximal extended orientation. In some embodiments, “α” (or alpha) equals to 8.75 to 14.5 degrees when forceps legs 12 are in a maximal extended orientation. In some embodiments, “α” (or alpha) equals to 10.25 to 13 degrees when forceps legs 12 are in a maximal extended orientation.
In some embodiments, measures/dimensions for the devices of the invention are further provided in table 1:
Reference is now made to
In some embodiments, “x” is the maximal diameter of a circle formed by the curve of distal curved grasping tip 22 of forceps, as shown in
In some embodiments, “y” is the maximal depth of distal curved grasping tip 22 of forceps, as shown in
In some embodiments, “z” is the minimal distance between the two ends of distal curved grasping tip 22 of forceps, as shown in
The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the market site, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2014/050367 | 4/18/2014 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 61813658 | Apr 2013 | US |
