GB1591878A - Intraocular lenses - Google Patents

Description

(54) INTRAOCULAR LENSES (71) I, CHARLES D. KELMAN, of 73 Bacon Road, Old Westbury, Nassau, New York, United States of America, a Citizen of the United States of America, do hereby declare the invention, for which I pray that a Patent may be granted to me, and the method by which it is to be performed, to be particularly described in and by the following statement: This invention relates to intraocular lenses suitable for use as artifical lens implants.

Lens implantation is a surgical technique which has come into increasing use for the correction of aphakia resulting from the surgical extraction (either extracapsular or intracapsular) of the natural lens from the patient's eye because of a blindness-causing condition such as cataract. In general format, an intraocular lens consists of a medial lens body about 4 mm in diameter and a plurality of lateral lobes usually projecting from different sides of the lens body for use in fixing the lens in position in the eye.

As is well-known to those skilled in this art, even though the diameter of the lens body of an intraocular lens is only about 4 mm, for the purpose of a lens implantation, a corneo-sclerical incision considerably longer than the lens body diameter, and normally from about 8 to 9 mm in length, is required. An incision of this magnitude is mandated because the incision must be capable of being spread far enough to accommodate both the thickness and the width of the lens. In this context, "thickness" means the dimension of the lens as measured from the anteriormost plane in which any part of the lens structure (e.g. the apex of the lens body) is found, to the posterior-most plane (e.g. the plane of the position fixation elements). "Width" means the minimum length of a projection of the lens onto a plane parallel to the optical axis of the lens body, in a direction perpendicular to a projection of the optical axis on such plane, which can be achieved by rotating the lens 360" about said optical axis.

According to the present invention there is provided an intraocular lens suitable for use as an artifical lens implant, in which the lens has a medial, light-focusing lens body, and a pair of lateral position fixation elements connected with said lens body, a first of said position fixation elements having a first portion connected to and extending generally laterally outwardly from a first region of the periphery of said lens body, and a second portion extending from said first portion generally transversely thereto and at least partly peripherally of said lens body, said second portion having that part of its peripheral e edge which faces said lens body spaced from the periphery of said lens body, and a second of said position fixation elements extending generally laterally outwardly from a second region of the periphery of said lens body spaced from and generally opposite said first region and in a direction generally opposite to that of said first portion of said first position fixation element, the configurations of said position fixation elements and their location with respect to said lens body being such that the minimum length of a projection of the entire lens onto a plane parallel to the optical axis of said lens body in a direction perpendicular to a projection of said optical axis on such plane which can be achieved by rotating the lens 360" about said optical axis, is greater than the minimum length of a projection of said lens body onto said plane in a direction perpendicular to a projection of said optical axis on such plane which can be achieved by rotating said lens body 360" about said optical axis, to an extent sufficient that insertion of the lens, through an incision in the eye, by a movement which is generally radial with respect to said optical axis would require the length of such incision to be greater than the minimum possible length of the incision which, as a function of the thickness and width of said lens body, would accommodate and permit passage therethrough of said lens body alone, and the maximum dimensions of each of said position fixation elements at any part thereof being such that the element can be accommodated in and pass longitudinally through said minimum length incision in the eyc.

The present invention is an intraocular lens construction which is characterized by a medial lens body and only two position fixation elements projecting from spaced, generally opposite lateral regions of the lens body. One of these elements has a first portion extending generally laterally from the lens body and a second portion extending from the end of the first portion generally transversely thereto and at least partly peripherally of the lens body, while the other element extends generally laterally from the lens body. The maximum dimensions of any portion of either position fixation element are such that it can be accommodated in and pass through the minimum length incision which is required to accommodate and permit passage of the lens body.

Preferably, both elements are unitary with the lens body, i.e. they are not separately attached elements but are formed with the lens body by molding or machining, for example) of a single block of any suitable physiologically inert and non-toxic synthetic plastics material such as are well known to the art, e.g. polymethylmethacrylate, but the position fixation elements may, as long as they have the requisite shapes and orientations, be constituted by platinum-iridium or equivalent metal wire loops.

The first portion or leg of the first position fixation element which is connected to the lens body, extends (as stated above) generally laterally of the lens body, while the transverse second portion of the element extends from the leg of first portion at least partly peripherally of the lens body. The said second portion must, however, be at a spacing from the periphery of the lens body sufficient easily to accommodate the thickness of the cornea and sclera of the eye, and preferably its circumferential length will be sufficient for it to extend through an arc of between about 40 and about 60 along the periphery of the lens body, with the opposite cxtremitics of the second portion of the first position fixation element as viewed in the plane of the periphery of the lens body being, respectively, located on two imaginary lines which are tangent to the lens body at opposite edges thereof and intersect at a point spaced from the lens body on the side opposite to that where the first position fixation element is located.

In an intraocular lens according to one embodiment of the present invention, which is particularly suited for an implantation in which the first and second position fixation elements are to be seated behind the iris in the lower and upper regions, respectively, of the cul-de-sac of the anterior and posterior capsules; the two position fixation elements are in precisely coplanar relation with one another both anteriorly and posteriorly. The two position fixation elements are also in coplanar relation with the lens body, and the term "substantially coplanar" wherever it appears in the Specification and claims in this regard means that the fixation elements and the lens body are coplanar with each other even though the convex anterior surface of the lens body may extend slightly beyond the anterior surface planes of the position fixation elements. As a modification of this embodiment of the present invention, it is contemplated that the second position fixation element may be offset slightly anteriorly with respect to the first position fixation element, so that it would seat against the front or anterior surface of the iris rather than behind it. As a still further modification of this embodiment of the present invention, it is contemplated that the second position fixation element may be a combination of the foregoing, i.e.

it would be composed of two parallel, spaced members one of which would be in the same plane as the first position fixation element while the other would be slightly offset anteriorly relative thereto, leaving therebetween a narrow space of at most about 1 mm in width into which the iris could be fitted so as to provide a means for immobilizing the tab-like position fixation element relative to the iris that would not require suturing. In both of the two justdescribed modifications, however, the respective second position fixation elements are deemed to be in substantially coplanar relation with the lens body, and the term "substantially coplanar" whenever it appears in the Specification and claims in this regard is to be interpreted accordingly.

The second position fixation element, when made of plastics and located so as to seat either behind or in front of the iris in the upper region of the cul-de-sac of the anterior and posterior capsules, normally will also be provided with means for enabling it to be sutured to the iris to achieve complete immobilization. Such means will preferably consist of an aperture provided within the confines of the element, but as an alternative a pair of notches could be provided on opposite sides edges of the element.

In use, when a lens according to the above embodiment of the present invention is being implanted, the surgeon will first make a corneo-scleral incision in the eye only slightly longer than the diameter of the lens body, i.e. the incision will be about 5 mm in length. In order to inscrt the lens into the eye, the surgeon will then introduce the lens essentially "longitudinally" into the eye, i.e.

he will in effect snake the lens in through the incision, starting with the free end extremity of the transverse second portion of the first position fixation element and ending with the tip of the second element, until the lens is properly positioned in the eye. This means that the second portion of the first position fixation element is seated behind the iris in the lower region of the cul-de-sac of the anterior and posterior capsules, that the lens body is properly centered in the region of the pupil, and that the second position fixation element (sutured to the iris, if necessary) is seated behind the iris in the upper region of the capsular cul-de-sac (or in front of the iris or embracing it, as the case may be, if one or the other of the modified forms of the lens is used). It will be understood that the two position fixation elements, upon implanatation of the lens, will cooperate to maintain the proper disposition of the lens body relative to the pupil of the eye.

The foregoing and other objects, characteristics and advantages of the present invention will be more clearly understood from the following detailed description thereof when read in conjunction with the accompanying drawings, in which: Figure 1 is a perspective view of an intraocular lens according to one embodiment of the present invention; Figure 2 is a plan view of the lens shown in Figure 1; Figure 3 is a sectional view taken along the line 3-3 in Figure 2; Figures 3A and 3B are fragmentary sectional views, similar to Figure 3, which illustrate, respectively, two modifications of the lens according to this embodiment of the present invention; Figure 4 is a diagrammatic vertical section through a human eye and shows a lens according to the embodiment of Figures 1 to 3 implanted in the eye; and Figures 5 and 6 are diagrammatic front views of a human eye and, respectively, illustrate the lens positions at the start and completion of the lens implantation procedure.

Referring now to the drawings in greater detail, an intraocular lens 10 according to one embodiment of the present invention is shown in Figures 1 to 3. The lens 10 consists of a light-focusing lens body 11 having a convex anterior surface 11 a and a flat posterior surface 1 1b, a first position fixation element 12 which has a flat anterior and posterior surfaces 12a and 12b, and a second position fixation element 13 which has flat anterior and posterior surfaces 13a and 13b and a medial suturing aperture 13c. The thicknesses of the lens body 11 and the two position fixation elements 12 and 13 are denoted by reference characters T and t, respectively, in Figures 3. As further clearly shown in Figure 3, the posterior surfaces 12b and 13b of the position fixation elements 12 and 13 are continuous with the posterior surface 1 1b of the lens body 11.

Within the contemplation of the present invention, therefore, the position fixation elements are substantially coplanar with the lens body even though the convex anterior surface lia of the latter protrudes somewhat anteriorly beyond the plane of the anterior surfaces 12a and 13a of the position fixation elements.

The position fixation element 12 includes a first or leg portion 12 'which is connected to and extends generally laterally from the lens body 11, and a second portion 12" which is either imperforate as shown or may have a large opening (not shown) defined within its expanse to permit anterior and posterior capsulary adhesion to take place through the opening after implantation of the lens, and which extends generally transversely from the first portion 12 'to one side thereof along and spaced from the periphery of the lens body 11. The length of the second portion 12"is sufficient to cover an arc of between about 40 and about 60 relative to the center of the lens body, and overall the construction is such that the oppositely lateral extremities (denoted by the reference characters U and V in Figure 2) of the first position fixation element 12 as viewed in the plane of the periphery of lens body 11 are located on two imaginary lines, denoted by the reference characters X and Y, which are tangent to the lens body at opposite edges thereof and intersect at a point (not shown because of space limitations) spaced from the lens body on the side thereof opposite to that where the first position fixation element 13 is located.

The position fixation element 13 also extends generally laterally from the lens body 11 but from a region of the periphery of the latter generally opposite that where the portion 12 ' of the first position fixation element 12 is located. Like the element 12, the element 13 is devoid of sharp corners and edges, for obvious reasons. As shown in Figure 2, the element 13 has in its outermost region a slight inclination to one side, here in a direction opposite to that of the portion 12" of the element 12, but it should be understood that such configuration of the element 13 is not an essential characteristic and the element may instead have a slight inclination in the other direction or actually be truly radially direction. It is nevertheless contemplated that in case a deflection or inclination off the truly radial orientation is provided, it will not be more than about 15 to about 20 .

It will be understood, of course, that except insofar as the maximum widths of the two position fixation elements, denoted E and F in Figure 2, must, for a given thickness t thereof, be such that each element can be accommodated in and pass longitudinally through the minimum length incision which is required to accommodate the lens body because of its diameter and thickness T, the precise dimensions of the lens 10 are in and of themselves not critical aspects of the present invention, since the physiological make-up of the eyes of different human beings may well dictate the choice of lenses of slightly different dimensional characteristics. Merely by way of example, however, the following dimensions, denoted A to H in figure 2, might be present in a representative lens 10 according to the present invention. The lens body diameter A may be 4 mm, its maximum thickness T 0.4 mm. and the overall lens length B 9 mm, with the distance C from the center of the lens body to the end edge of the position fixation element 13 being 4 mm, and the distance D from the centre of the lens body to the end edge of the position fixation element 12 being 5 mm. The maximum widths F and F of the two position fixations elements may be 2.1 mm, their thickness t may be 0.2 mm, the diameter G of the suturing hole may be 0.75 mm, and the minimum width H ot the space between the periphery of the lens body 11 and the proximate edge of the second portion 12"of the first position fixation element 12 may be about 1 mm. With reference to a diametral line of the lens body parallel to the dimension line B, and a diametral line through the extremity V, the arc length of the second portion 12'bf the element 12 may be 45 , and the angle between that dimetral line and a line connecting the centers of the lens body and the suturing hole may be 12". The angle of inclination of the outwardmost section of the second position fixation element 13 relative to the radial direction of the section of that element contiguous to the lens body may be 150.

The manner of use of an intraocular lens 10 according to this embodiment of the present invention, when the same is to be implanted in the eye of a human being. will now be described with reference to Figures 4, 5 and 6. It is noted at this point, however that the instant application is not intended to serve as a technically and medically complete primer for lens implantation surgery.

Rather, the description and illustration of some of the surgical aspects of such an operation that are presented herein are purely diagrammatic, and they are intended only to provide basic signposts to those skilled in the art as to how such an intraocular lens is to be implanted.

Turning now to the operation itself.

assuming the patient has been properly prepared and anesthetized. the surgeon will first make a corneo-scleral incision 14 in the eyeball of the patient near the upper front region thereof, as shown in Figs. 5 and 6.

For the sake of simplicity, in those views a part of the cornea 15 is illustrated broken away, and the internal elements of the eye, such as the iris, the posterior capsules and the zonules, have been omitted entirely. The incision is made about 5 mm long, i.e. just sufficient to enable it to be spread to the degree required to accommodate both the diameter and the thickness of the lens body 11.

With the incision properly spread apart, the lens 10 is then inserted essentially "longitudinally" into the eye through the incision, i.e. starting with the free end of the second portion 12"of the first position fixation element 12 (Fig. 5). At the initial stage of the insertion. therefore, as shown in Fig.

5, the lens body 11 will be located somewhat off to one side of the incision. Once the leading end region of the portion 12'of the position fixation element 12 is disposed in the anterior chamber of the eyeball, however, the lens is in effect rotated counterclockwise, as indicated by the broken-line arrow 16, until the first portion 12 ' of the position fixation element 12 and the lens body 11 are located immediately in front of the incision 14. The remaining parts of the lens 10, i.e.

the lens body 11 and the second position fixation element 13, are then fed through the incision. During this stage, the portion 12"of the position fixation element 12 is guided (Figs. 4 and 6) into the lower region of the cul-de-sac 17 of the anterior and posterior capsules 18 and 19 behind the lower region of the iris 20, where the element fits in properly by virtue of its arcuate end edge, and the position fixation element 13 is inserted into the upper region of the cul-de-sac of the anterior and posterior capsules behind the upper region of the iris 20 and is sutured to the iris at that location by means of appropriate sutures 21. With the implantation so completed, the lens 10 will be securely seated in the eye, and the lens body 11 will be maintained in its proper position with respect to the pupil 22 of the eye by the cooperation of the two position fixation elements in providing a three-point support of the lens. Finally, of course, the incision 14 is sutured to close the wound.

In the lens according to the present invention so far described, the position fixation element 13 is adapted to seat behind the iris, as shown in Fig. 4. Should it be desired however, to suture the position fixation element 13 to the iris at the front thereof and not to have it seated in the upper region of the cul-de-sac of the anterior and posterior capsules 18 and 19, an modified intraocular lens 23 according to the invention, as shown in Fig. 3A, would be used. In the lens 23, the first position fixation element 12 (not shown in this view) is the same as shown in Figs. 1 and 2, but the second position fixation element 24 is offset slightly, to the extent of about 1 mm, anteriorly with respect to the plane of the first position fixation element.

In accordance with the present invention also, especially if suturing of the second position fixation element to the iris is to be avoided, the immobilization of that element relative to the iris may be effected by means of a further modified lens 25 such as shown in Fig. 3B. In the lens 25, where again the first position fixation element 12 (not shown) is the same as in Figs. 1 and 2, the second position fixation element 26 is in essence a combination of the elements 13 and 24 shown in Figs. 3 and 3A, in that it consists of a posterior member 26 ' coplanar with the first position fixation element 12 and an anterior member 26"slightly offset anteriorly with respect to the member 26 There is, accordingly, defined between the two members a narrow space 27, approximately 1 mm wide, into which the juxtaposed portion of the upper region of the iris can be inserted so as to be confined between the members 26' and 26" which would adhere to the iris sufficiently to immobilize the position fixation element 26 relative thereto. It will be apparent, of course, that the overall thickness of the position fixation element 26 in the lens 25 will be only about 1.4 mm, i.e. still less than the maximum thickness T of the lens body 11, so that there will be no interference with the passage of this position fixation element through the incision 14. As will further be clear to those skilled in the art, if desired one or both of the members 26 ' and 26'bf the position fixation element 26 in the lens 25 may be provided with means, such as a suturing hole, to permit suturing thereof to the iris. As previously indicated, of course, the second position fixation element in any of the lens forms so far described may, in lieu of a suturing hole be provided at its opposite side edges with a pair of appropriately arranged notches to receive the sutures.

Reference is directed to my copending application no. 46628/77 (serial number: 1591877) from which this application is divided.

WHAT WE CLAIM IS: 1. An intraocular lens suitable for use as an artifical lens implant, in which the lens has a medial, light focusing lens body, and a pair of lateral position fixation elements connected with said lens body, a first of said position fixation elements having a first portion connected to and extending generally laterally outwardly from a first region of the periphery of said lens body, and a second portion extending from said first portion generally transversely thereto and at least partly peripherally of said lens body, said second portion having that part of its peripheral edge which faces said lens body spaced from the periphery of said lens body, and a second of said position fixation elements extending generally laterally outwardly from a second region of the periphery of said lens body spaced from and generally opposite said first region and in a direction generally opposite to that of said first portion of said first position fixation element, the configurations of said position fixation elements and their location with respect to said lens body being such that the minimum length of a projection of the entire lens onto a plane parallel to the optical axis of said lens body in a direction perpendicular to a projection of said optical axis on such plane which can be achieved by rotating the lens 360" about said optical axis, is greater than the minimum length of a projection of said lens body onto said plane in a direction perpendicular to a projection of said optical axis on such plane which can be achieved by rotating said lens body 360" about said optical axis, to an extent sufficient that insertion of the lens, through an incision in the eye, by a movement which is generally radial with respect to said optical axis would require the length of such incision to be greater than the minimum possible length of the incision which, as a function of the thickness and width of said lens body, would accommodate and permit passage therethrough of said lens body alone, and the maximum dimensions of each of said position fixation elements at any part thereof being such that the element can be accommodated in and pass longitudinally through said minimum length incision in the eye.

2. An intraocular lens as claimed in claim 1, wherein said second position fixation element is provided with means to permit suturing of that element to the iris of the eye.

3. An intraocular lens as claimed in claim 2, wherein said means to permit suturing is a medial aperture provided in said second position fixation element.

4. An intraocular lens as claimed in claims 1 to 3 wherein said second position fixation element is disposed in coplanar relation with said first position fixation element.

5. An intraocular lens as claimed in claims 1 to 3 wherein said other second position fixation element is offset slightly anteriorly relative to said first position fixation element.

6. An intraocular lens as claimed in claim 1, wherein said second position fixation element includes a first member coplanar with said first position fixation element and a second member parallel to said first member and offset slightly anteriorly therefrom to define a narrow space therebetween in which a juxtaposed portion of the iris can

**WARNING** end of DESC field may overlap start of CLMS **.

Claims (14)

1. **WARNING** start of CLMS field may overlap end of DESC **.

   the extent of about 1 mm, anteriorly with respect to the plane of the first position fixation element.

   In accordance with the present invention also, especially if suturing of the second position fixation element to the iris is to be avoided, the immobilization of that element relative to the iris may be effected by means of a further modified lens 25 such as shown in Fig. 3B. In the lens 25, where again the first position fixation element 12 (not shown) is the same as in Figs. 1 and 2, the second position fixation element 26 is in essence a combination of the elements 13 and 24 shown in Figs.

   3 and 3A, in that it consists of a posterior member 26 ' coplanar with the first position fixation element 12 and an anterior member 26"slightly offset anteriorly with respect to the member 26 There is, accordingly, defined between the two members a narrow space 27, approximately 1 mm wide, into which the juxtaposed portion of the upper region of the iris can be inserted so as to be confined between the members 26' and 26" which would adhere to the iris sufficiently to immobilize the position fixation element 26 relative thereto. It will be apparent, of course, that the overall thickness of the position fixation element 26 in the lens 25 will be only about 1.4 mm, i.e. still less than the maximum thickness T of the lens body 11, so that there will be no interference with the passage of this position fixation element through the incision 14. As will further be clear to those skilled in the art, if desired one or both of the members 26 ' and 26'bf the position fixation element 26 in the lens 25 may be provided with means, such as a suturing hole, to permit suturing thereof to the iris. As previously indicated, of course, the second position fixation element in any of the lens forms so far described may, in lieu of a suturing hole be provided at its opposite side edges with a pair of appropriately arranged notches to receive the sutures.

   Reference is directed to my copending application no. 46628/77 (serial number: 1591877) from which this application is divided.

   WHAT WE CLAIM IS: 1. An intraocular lens suitable for use as an artifical lens implant, in which the lens has a medial, light focusing lens body, and a pair of lateral position fixation elements connected with said lens body, a first of said position fixation elements having a first portion connected to and extending generally laterally outwardly from a first region of the periphery of said lens body, and a second portion extending from said first portion generally transversely thereto and at least partly peripherally of said lens body, said second portion having that part of its peripheral edge which faces said lens body spaced from the periphery of said lens body, and a second of said position fixation elements extending generally laterally outwardly from a second region of the periphery of said lens body spaced from and generally opposite said first region and in a direction generally opposite to that of said first portion of said first position fixation element, the configurations of said position fixation elements and their location with respect to said lens body being such that the minimum length of a projection of the entire lens onto a plane parallel to the optical axis of said lens body in a direction perpendicular to a projection of said optical axis on such plane which can be achieved by rotating the lens 360" about said optical axis, is greater than the minimum length of a projection of said lens body onto said plane in a direction perpendicular to a projection of said optical axis on such plane which can be achieved by rotating said lens body 360" about said optical axis, to an extent sufficient that insertion of the lens, through an incision in the eye, by a movement which is generally radial with respect to said optical axis would require the length of such incision to be greater than the minimum possible length of the incision which, as a function of the thickness and width of said lens body, would accommodate and permit passage therethrough of said lens body alone, and the maximum dimensions of each of said position fixation elements at any part thereof being such that the element can be accommodated in and pass longitudinally through said minimum length incision in the eye.
2. 2. An intraocular lens as claimed in claim 1, wherein said second position fixation element is provided with means to permit suturing of that element to the iris of the eye.
3. 3. An intraocular lens as claimed in claim 2, wherein said means to permit suturing is a medial aperture provided in said second position fixation element.
4. 4. An intraocular lens as claimed in claims 1 to 3 wherein said second position fixation element is disposed in coplanar relation with said first position fixation element.
5. 5. An intraocular lens as claimed in claims 1 to 3 wherein said other second position fixation element is offset slightly anteriorly relative to said first position fixation element.
6. 6. An intraocular lens as claimed in claim 1, wherein said second position fixation element includes a first member coplanar with said first position fixation element and a second member parallel to said first member and offset slightly anteriorly therefrom to define a narrow space therebetween in which a juxtaposed portion of the iris can

   be confined.
7. 7. An intraocular lens as claimed in claims 1 to 6 wherein the length of said second portion of said first position fixation element is such that it extends along said periphery of said lens body through an are of between about 40 and about 60".
8. 8. An intraocular lens as claimed in claim 7 wherein the length of said second portion of said first position fixation element is such that it extends along said periphery of said lens body through an are of about 45".
9. 9. An intraocular lens as claimed in claim l, wherein said second position fixation element has a first portion connected to oriented generally radially of said lens body, and a second portion inclined to one side of said first portion at an angle of not more than about 20" to the radial direction.
10. 10. An intraocular lens as claimed in any of claims I to 9 wherein said position fixation elements are constructed and arranged such that said second portion of said first position fixation element and the tip end region of said second position fixation element coact to provide a three-point support for properly positioning the lens in the eye.
11. 1 1. An intraocular lens as claimed in any of claims I to 10 in which the oppositely lateral extremities of said first position fixation element as viewed in the plane of the periphery of said lens body being. respec- timely located on two imaginary lines which are substantially tangent to said lens body at opposite edges thereof and intersect at a point spaced from said lens body on the side thereof opposite to that where said first position fixation element is located, and the maximum dimensions of each of said position fixation elements at any part thereof being such that that element can be accommodated in and pass longitudinally through the minimum length incision in the eye which is required as a function of the diameter and thickness of said lens body to accommodate and permit passage of said lens body.
12. 12. An intraocular lens as claimed in claim 11 wherein said second position fixation element is disposed in coplanar relation with said first position fixation element.
13. 13. An intraocular lens as claimed in claim I 1 wherein the length of said second portion of said first position fixation element is such that it extends along said periphery of said lens body through an arc of between about 40 and about 60".
14. 14. An intraocular lens suitable for use as an artifical lens implant substantially as hereinbefore described with reference to and as illustrated in Figures 1 to 3, 5 and 6 of the accompanying drawings; or in those Figures as modified by Figure 3A or Figure 3B of the accompanying drawings.