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WO1996013215A9 - PROCEDE ET APPAREIl DE TRANSPLANTATION SANS SUTURE D'UNE CORNEE - Google Patents

PROCEDE ET APPAREIl DE TRANSPLANTATION SANS SUTURE D'UNE CORNEE

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Publication number
WO1996013215A9
WO1996013215A9 PCT/US1995/013932 US9513932W WO9613215A9 WO 1996013215 A9 WO1996013215 A9 WO 1996013215A9 US 9513932 W US9513932 W US 9513932W WO 9613215 A9 WO9613215 A9 WO 9613215A9
Authority
WO
WIPO (PCT)
Prior art keywords
donor material
central
die
tabs
central extent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1995/013932
Other languages
English (en)
Other versions
WO1996013215A1 (fr
Filing date
Publication date
Priority claimed from US08/289,670 external-priority patent/US5584881A/en
Priority claimed from US08/329,720 external-priority patent/US5755785A/en
Priority claimed from US08/329,709 external-priority patent/US5649944A/en
Application filed filed Critical
Priority to AU40144/95A priority Critical patent/AU4014495A/en
Publication of WO1996013215A1 publication Critical patent/WO1996013215A1/fr
Publication of WO1996013215A9 publication Critical patent/WO1996013215A9/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Definitions

  • a further object of the invention is to transplant a cornea without sutures comprising (1) a donor material in the shape of a partial sphere having a central extent, the central extent being of the size and shape of the central portion of the cornea of the eye, the central extent having a periphery and an exterior surface in a convex configuration and an interior surface in a concave configuration and with an essentially common thickness throughout, the central extent having a plurality of corneal tabs extending radially from the periphery of the central extent, the tabs having exterior surfaces as a continuation of the exterior surface of the central extent and (2) a recipient eye in the shape of a partial sphere having an aperture in the cornea at its central portion, the aperture in the cornea being of a size and shape essentially that of the periphery of the central extent of the donor material, the central portion having pockets equal in number to the plurality of tabs of the donor material and aligned therewith, and with the central extent of the donor material located within the aperture of the recipient eye and with the tabs of the central extent being
  • Fig. 5 is a side elevational view of the trephine of Fig. 4 and an associated block;
  • Fig. 7 is a side elevational view similar to Figs. 5 and 6 but showing the trephine in the retracted position after the cut;
  • Fig. 9C is a transverse cross-sectional view of the upper portion of the male die illustrating the transverse cross-sectional configuration of the male die;
  • Fig. 9D is a perspective view of the upper portion of the male die with the die-cut donor material shown in phantom therein;
  • Fig. 10A is a longitudinal cross-sectional view of the female die of the outline cutter assembly of the invention taken through the cutting teeth thereof;
  • Fig. 15 is an exploded diagram of the tab shaver assembly of the invention illustrating the base support, hand support, the tab shaver punch and the spring-loaded medical syringe thereof;
  • Fig. 16 is a longitudinal cross-sectional view of Fig. 15;
  • Fig. 17 is a transverse cross-sectional view of Fig. 15;
  • Fig. 18A is a cross-sectional view of the male die of the tab shaver assembly taken through the upstanding arms thereof;
  • Figs. 18B-18E illustrate the operation of the tab shaver;
  • Figs. 19A-19C illustrate a tool for carrying out the preparation of the donor material according to an embodiment of the instant invention;
  • Figs. 21A-21D illustrate sequentially the appearance of the donor material during the corneal preparation according to a method of the instant invention
  • Figs. 22A-22C illustrate a tweezer punch according to the present invention utilized for punching a hole in the tabs of the donor material so as to form barbs extending outwardly from the upper or lower surface of the tab;
  • Figs. 23A and 23B illustrate the preferred configuration of the tabs formed in the tabs by the tweezer punch of Figs. 22A-22C. Similar reference characters refer to similar parts throughout the several views of the drawings.
  • the present invention as illustrated in Figs. 1 and 2 relates to an eye 10 with a cornea 12 repaired with minimal or no sutures.
  • the repaired cornea 12 includes two major components, the donor material 14 of living tissue and the recipient eye 10.
  • Such material is cut to a particular shape prior to being coupled with the recipient eye 10.
  • the shape is that of a partial sphere.
  • Such sphere has a generally circular central extent 16.
  • the central extent 16 is of the size and shape of the central portion of the cornea of an eye.
  • the central extent 16 has a periphery 18 of a fixed diameter of about 7.0 and 7.5 millimeters. It has an exterior surface 20 in a convex configuration. It also has an interior surface 22 in a concave configuration.
  • the central extent 16 also has an essentially common thickness throughout .
  • a plurality of symmetrically positioned diamond-shaped corneal tabs 24 Formed as part of the central extent 16 are a plurality of symmetrically positioned diamond-shaped corneal tabs 24. Four to sixteen of such tabs is the preferred number and six is the most preferred. Such tabs 24 extend radially from the periphery 18 of the central extent 16.
  • the tabs 24 have exterior surfaces 26 as a continuation of the exterior surface 20 of the central extent 16.
  • the exterior surfaces 20 and 26 of the central extent 16 and tabs 24, respectively, are preferably of a common Bowman's membrane 28 typically having a thickness of about 100 microns.
  • the next component of the repaired cornea is the recipient eye 10.
  • Such eye 10 is in the shape of a partial sphere.
  • the recipient eye 10 is formed with a circular central aperture 38 at its central portion 40.
  • the circular central aperture 38 is of a size and shape essentially that of the periphery 18 of the central extent 16 of the donor material 14 for the receipt thereof .
  • the periphery 42 of the aperture 38 is of a common thickness.
  • the central portion 40 has a plurality (four illustrated) of symmetrically positioned pockets 46.
  • the pockets 46 are simply incisions made into the thickness of the cornea, preferably just under the Bowman's membrane 28 into the periphery 42 of the aperture 38.
  • the pockets 46 each constitute between about 10 and 100 percent of the periphery 42 of the aperture 38.
  • each pocket 46 is between about 25 and 75 percent of the diameter of the aperture 38.
  • the central extent 16 of the donor material 14 is positioned within the aperture 38 of the recipient eye 10.
  • the tabs 24 of the central extent 16 are imbricated into the pockets 46 of the recipient eye 10. Forceps are preferably used for the positioning of the central extent 16 and the imbrication of each of the tabs 24 into their respective pockets 46.
  • Additional cuts are then made at the juncture between the central extent 16 and the tabs 24 to a depth of about 90 percent of the thickness of the central extent 16, thereby leaving intact the common Bowman's membrane 48 of the central extent 16 and the tabs 24 that constitutes the convex exterior surfaces 20 and 26 of the central extent 16 and the tabs 24, respectively. Finally, additional cuts are made parallel along the Bowman's membrane 28 constituting the exterior surface 26 of the tabs 24 so as to remove the corneal material from the tabs 24 while leaving intact the Bowman's membrane 28 of the tabs 24 and the central extent 16.
  • the recipient eye 10 is prepared according to the method of this invention by first marking the intended location of the pockets 46 with a conventional corneal marking tool (not shown) .
  • the circular aperture 38 is then cut into the central portion 40 of the recipient eye 10 by means of a conventional trephine or the like (not shown) which makes a circular cut through the central portion 40 whereupon the central portion 40 of the recipient eye 10 is removed and discarded.
  • the pockets 46 are then formed into the periphery 42 of the central aperture 38 and the recipient eye 10 by means of a conventional diamond knife (not shown) having a width equal to the proximal width of the openings of the pockets 46 intended to be formed in the periphery 42 of the circular aperture 38.
  • the tabs 24 may be more securely retained therein by forming a notch or otherwise nicking the tabs 24 at their juncture with the central extent 16 thereby allowing the narrower-width edges of the pocket openings to engage therein. It is also noted that to minimize astigmitation due to swelling, the pockets 46 may be cut further interiorally as shown in Fig. 3A. Without departing from the spirit of the invention, in the event that the donor material 14 shifts post operatively due to trauma or otherwise, the tabs 24 may be temporarily secured in the respective pockets 46 by means of sutures.
  • transplantation method of this invention is not limited to corneal transplantation and may be implemented in other transplantations without departing from the spirit and scope of this invention.
  • Transplantation Trephine and Method of Use In addition to the eye with a repaired cornea and the method of repairing a cornea as set forth above, the present invention also includes a trephine 52.
  • cylindrical support 56 of the invention is adapted to be held by a surgeon in the cutting of the donor material 14.
  • the trephine 52 includes a cylindrical central portion 68 with an upper edge 70 and a lower edge 72.
  • a central axis 73 extends along the length of the cylindrical support 56.
  • the plurality of circular cutting blades 58 and 60 are formed in the lower edge 72 of the cylindrical support 56.
  • the circular cutting blades 58 and 60 include an exterior continuous cutting blade 74 having a diameter between about 11 and 12 millimeters.
  • the cutting blades 58 and 60 also include an interior discontinuous cutting blade 76 having a diameter of about between 7 and 7 1/2 millimeters.
  • the radially extending blades 62 are located between the circular blades 58 and 60.
  • the exterior circular blade 60 is located closer to the upper edge 70 of the cylindrical support 56 than the interior circular blade 58 by a distance of about 100 microns equal to the thickness of the Bowman's membrane 28.
  • the radial blades 62 thus extend at an acute angle with respect to the upper edge 70 of the support 56.
  • the radial blades 62 are eight in number and arranged for cutting diamond shaped tabs 24.
  • the tabs 24 together constitute between about 10 and 100 percent of the circumvents of the inner and outer circular blades 58 and 60.
  • the radially interior edge 96 of the interior cutting blade 76 is blunt to preclude cutting of donor material 14 at the location of the tabs 24.
  • a block 64 In association with the above trephine 52, there is provided a block 64.
  • Such block 64 has a pocketed, generally spherical surface 80.
  • Such spherical surface has a radius of curvature of about 7.5 millimeters. The purpose of such surface is for constituting a support for the donor material 14 during the cutting thereof by the trephine 52.
  • the steps include providing a cylindrical support 56 of the type as described above.
  • the method then includes the step of providing a plurality of circular cutting blades 58 and 60 in the cylindrical support 56 as described above.
  • the method also includes the step of providing radially extending blades 62 between the circular blades 58 and 60 as described above.
  • the invention also includes the step of providing an associated block 64 as described above.
  • the method of the invention then includes the step of positioning donor material 14 adapted to be used in corneal transplants on the support surface 80 of the block 64 and cutting such supported donor material 14 with the trephine 52 as described above.
  • the incisions which extend generally parallel with the upper and lower surfaces of the eye 10 beneath the Bowman's membrane 28 are preferably done by a conventional diamond knife in the manner described above.
  • a trephine blade which punches out the donor material to 90 percent of the corneal thickness
  • a trephine blade which punches out the donor material at a rim of 10-12 millimeters
  • the method of securing the donor tab in the recipient rim is with forceps that allow manipulation of the tabs in the postoperative period to reduce the astigmatism and to allow for a spherical surface;
  • the recipient bed is incised in a step fashion to coapt the stroma
  • a diamond knife is provided which produces an undermined tab of Bowman's membrane
  • a corneal punch which produces donor tabs of Bowman's membrane
  • the invention also comprises an outline cutter assembly 100 as shown in Figs. 8-14 for cutting the outline of the donor material 14 inclusive of the central extent 16 and the tabs 24 and a tab shaver assembly 102 as shown in Figs. 15-18 for shaving the tabs 24 to remove the corneal material from the tabs 24 leaving the Bowman's membrane 28 of the tabs 24 intact with the Bowman's membrane 28 of the central extent 16.
  • the outline cutter assembly 100 shown in Figs. 8-14 comprises a male die 104 rigidly extending vertically from a generally-rectangular base support 106, a female die 108 rigidly supported within a hand support 110 and a tab incisor punch 112.
  • the male die 104 comprises a generally circular cylindrical member 114 having an increased diameter upper portion 116 and a reduced diameter lower portion 118.
  • Equally-spaced slots 120 are machined longitudinally along the length of the upper portion 116 to form a castellated configuration. Slots 120 are configured and dimensioned such that the cross-sectional configuration (see Fig. 9C) of the upper portion 116 of the male die 104 is the same as the desired outline configuration of the donor material 14 inclusive of its central extent 16 and tabs 24.
  • the upper portion 116 of the cylindrical member 114 is machined with six equally-spaced slots 120.
  • the sides 122 of slots 120 may be machined as radii of the cylindrical member 114.
  • the outer diameter of the upper portion 116 of the cylindrical member 114 being determined to equal the desired outer diameter of the donor material 14, the depth at which the slots 120 are machined into such upper portion 116 determines the outer diameter of the central extent 16 of the donor material 14 and thus, the relative size of its tabs 24.
  • the upper end 126 of the upper portion 116 of the cylindrical member 114 is machined concavely to a partially-spherical configuration having a radius substantially equal to the spherical radius of the exterior surface 20 of the donor material 14. It is noted that the spherical machining of the upper end 126 creates upwardly extending sharp edges 128 in an outlined configuration of the slotted upper end 126 of the upper portion 116 of the cylindrical member 114. As will become apparent below, the sharp edges 128 serve to cut the donor material 114 in an outline configuration inclusive of its central extent 116 and tabs 24.
  • the male die 104 preferably includes a central blind hole 104B extending from its lower portion 118 and into its upper portion 116, and a plurality of suction holes 104S extending from the blind hole 104B to the surface of its upper end 126.
  • a source of vacuum is fluidly connected to the blind hole 104B and the donor material 14 is positioned on the upper end 126, the vacuum in the suction holes 104S assures that the donor material 14 will remain securely seated.
  • the female die 108 comprises a generally circular cylindrical member 130 having an annular cutting rim 132 with cutting teeth 134 extending downwardly therefrom.
  • the radially outward surfaces of the annular cutting rim 132 and the cutting teeth 134 are frustro-conically shaped such that the lowermost edge 136 of the cutting rim 132 and the lowermost edges 138, as well as side edges 140, of the cutting teeth 134 define sharp cutting edges .
  • the cutting teeth 134 of the female die 108 are appropriately configured and dimensioned to axially mate with and slide into the slots 120 formed in the upper portion 116 of the male die 104 such that when the donor material 14 is positioned therebetween and the dies 104 and 106 are axially mated together, the donor material 14 is precisely die-cut into the desired outline configuration.
  • the frustro-conical shape of the cutting teeth 134 as well as the cutting rim 132 assures that the donor material 14 is cylindrically cut even though the donor material 14 (and the upper end 26 of the male die 104) are partially spherically shaped.
  • the male die 104 is supported by the base support 106
  • female die 108 is supported by the hand support 110 and the supports 106 and 108 are axially movable relative to one another by means of guide pins 14IA and 14IB.
  • base support 106 comprises a generally hollow rectangular configuration defined by rim 106R and a flat top surface 106S from which a boss 106B interiorly extends.
  • the lower portion 118 of the cylindrical member 114 of the male die 104 is rigidly positioned into a cylindrical blind hole 142 in the boss 106B of the base support 106.
  • Blind hole 142 is formed at a right angle to the flat upper surface 106S of the base support 106 such that the upper portion 116 of the male die 104 extends perpendicularly therefrom.
  • the guide pins 141A and 141B are rigidly mounted into guide holes 143A and 143B in the boss 106B of the base support 106 so as to extend parallel to each other and to the male die 104.
  • a vacuum hole 144 extends from the exterior of the boss 106B to the blind hole 142. Its opened end 144E is dimensioned to be fitted with a source of vacuum, such as a spring-loaded medical syringe 146.
  • the spring 146S of such a spring- loaded medical syringe 146 preferably includes a spring constant that creates the desired vacuum within the blind and vacuum holes 142 and 144 (and correspondingly the male die 104) so as to assure that the donor material 14 is held in its seated position within the spherical upper end 126 of the male die 104.
  • access hole 148 formed in the rim 106R of the base support 106 supports the syringe 146 in collinear alignment with the vacuum hole 144.
  • the hand support 110 in which is positioned the female die 108 (or formed integrally therewith as shown) , comprises a central bore 150 for receiving the female die 108 and a pair of side bores 152A and 152B for slideably receiving the guide pins 141A and 141B of the base support 106.
  • the central bore 150 is positioned relative to the side bores 152A and 152B such that the female die 108 is positioned in precise axial alignment with the male die 104 when the guide pins 14IA and 141B are positioned into the respective side bores 152A and 152B, thereby permitting the female die 108 to axially engage the male die 104 as shown in Figs. 11 and 12 with the hand support 110 eventually being seated on the upper surface 106S of the base support 106.
  • the longitudinal positioning of the female die 108 within the central bore 150 determines the extent by which the female die 106 mates with and extends along the length of the upper portion 116 of the male die 104.
  • the hand support 110 comprises a substantially oblong configuration that can be easily grasped by the physician performing the corneal transplantation and then conveniently oriented and aligned with the base support 106 such that the guide pins 141A and 141B engage into the side bores 152A and 152B, respectively.
  • the outer exterior surfaces of the hand support 110 may be knurled 154 to facilitate better grasping of the hand support 110 by the physician.
  • a donor material support assembly 156 is preferably provided to provide additional support to the donor material 14 when it is positioned onto the upper end 126 of the male die 104 prior to cutting. More particularly, as shown in Fig. 13, the donor material support assembly 156 comprises a generally frustro-conical spreader tool 158 having a recess 160 formed at its wide, lower end. The spreader tool 158 facilitates the positioning of an 0- ring 162 onto the male die 104 by simply positioning the recessed end 160 of the spreader tool 158 onto the upper end 126 of the male die 104 and then positioning an O-ring 162 about the tip 164 of the spreader tool 158.
  • an annular-shaped donor material supporter 166 with central hole 168 may then be positioned about the male die 104 and rested upon the O-ring 162. It is noted that the upper portion of the central hole 168 may be spherically recessed 170. In this manner, the depth of the recessed end 160 of the spreader tool 158 may be dimensioned such that the O-ring 162 is positioned about the male die 104 at a location that aligns the spherical recess 170 of the supporter 166 with the spherical upper end 126 of the male die 104.
  • the donor material supporter 166 assures that the donor material 14 retains its spherical shape while it is being die cut by the male and female dies 104 and 108.
  • central bore 150 of the hand support 110 may include a step portion 172 substantially equal in diameter to the diameter of the supporter 166.
  • Step portion 172 is preferably positioned within the central bore 150 at a position slightly below the sharp edges 138 of the cutting teeth 134 of the female die 108 such that the supporter 166 is forced downwardly by means of the step portion 172 without actually engaging the sharp edges 138 and possibly dulling the same.
  • the tab incisor punch 112 of the outline cutter assembly 100 functions to incise the circular configuration of the central extent 16 from the concave interior surface 22 thereof up to the Bowman's membrane 28 constituting the convex exterior surface 20 thereof. More particularly, the tab incisor punch 112 comprises a generally circular cylindrical configuration having an increased diameter portion 174 and a reduced diameter portion 176 that form a step 178 therebetween. A knurl 180 is formed about the outer surface of the increased diameter portion 174 to facilitate it functioning as a handle for easy grasping by the physician. The reduced diameter portion 176 is dimensioned to slideably engage into the upper portion of the central bore 150 of the hand support 110.
  • annular cutter 182 extends concentrically from the bottom 184 of the reduced diameter portion 176.
  • the annular cutter 182 is frustro-conically shaped such that its cylindrical lumen is positioned parallel and concentrically with the axis of the punch 112.
  • the relative lengths of the annular cutter 182, the reduced diameter portion 176, the central bore 150 are such that the sharp edge of the annular cutter 182 is positioned away from the spherical recess of the end 126 of the male die 104 by thickness of the Bowman's membrane 28 (e.g., 100 microns) when the hand support 110 is seated on the surface 106S of the base support 106 and when the step portion 172 is engaged with the upper edge of the central bore 150.
  • the incisor punch 112 can be easily inserted into the central bore 150 of the hand support 110 and moved downwardly until seated. When seated, a precise cut is made about the periphery of the central extent 16 through the thickness thereof up to the Bowman's membrane 28 thereof. The Bowman's membrane 28 of the central extent 16 and the tabs 24 therefore remains intact.
  • the donor material 14 may then be removed from the outline cutter assembly 100 by removing the incisor punch 112 and the hand support 110 and releasing the vacuum.
  • the donor material 14, now outlined die-cut may then be positioned within the tab shaver assembly 102 of the invention to shave off the excess donor material proximate to the Bowman's membrane 28 of the tabs 24.
  • the tab shaver assembly 102 of the invention is illustrated in Figs. 15-18 and comprises a vertically-disposed male die 190 that supports the outline die-cut donor material 14, a female die 192 that bends the tabs 24 of the donor material 14 downwardly along the length of the male die 190 when the dies 190 and 192 are engaged, and a tab shaver punch 194 that shaves the excess donor material from the tabs 24 while leaving the Bowman's membrane 28 intact.
  • many components of the tab shaver assembly 102 are similar to the corresponding components of the outline cutter assembly 100. Therefore, the similar components of the tab shaver assembly 102 are referenced by primed reference numerals and are not individually described in detail again.
  • the male die 190 of the tab shaver assembly 102 comprises a generally cylindrical castellated configuration with an increased diameter step 196 that functions to locate the male die 190 in the blind hole 142' in the boss 106B' of the base support 106' (see Fig. 16) .
  • the upper end 126' is machined to a spherical configuration having a radius substantially equal to the spherical radius of the donor material 14.
  • a plurality of arms 198 extend longitudinally from the outer circumferential surface of the male die 190. Arms 198 are preferably spaced equidistantly and each include a width substantially equal to the distance between the tabs 24 of the die- cut donor material 14. In this manner, as shown in Fig.
  • the die cut donor material 14 when the die cut donor material 14 is removed from the outline cutter assembly 100 of the invention, it can be seated upon the upper end 126' of the male die 190 with the tabs 24 thereof extending radially outwardly between the respective arms 198.
  • the donor material 14 may be secured into position by means of the vacuum hole 144', blind holes 142' and 104B 1 , suction holes 104S, and a vacuum source such as the spring-loaded medical syringe 146'.
  • the female die 192 is positioned within, or formed integrally with (as shown), the central bore 150' of the hand support 110'. As best shown in Figs. 16 and 17, the female die 192 simply comprises a central hole 200 that has a diameter appreciably greater than the diameter of the male die 190. The female die 192 is positioned vertically within the central bore 150' of the hand support 110' such that the central hole 200 bends over the tabs 24 of the donor material 14 along the length of the male die 190 as the hand support 110 is seated onto the upper surface 106S' of the base support 106'.
  • the diameter of central hole 200 is marginally greater than the diameter of the male die 190 (equal to the diameter of the central extent 16) plus twice the thickness of the Bowman's membrane 28 (e.g. 2 x 100 microns) .
  • the diameter of the male die 190 equal to the diameter of the central extent 16
  • twice the thickness of the Bowman's membrane 28 e.g. 2 x 100 microns
  • the tab shaver punch 194 is similar in design to the tab incisor punch 112 described above. Consequently, primed reference numerals are used in the drawings to refer to the similar components of the tab shaver punch 194 and are not discussed separately.
  • the annular cutter 182 ' of the tab shaver punch 194 includes an extended length (greater than that of the annular cutter 182 of the tab incisor punch 112) . Furthermore, the diameter of the lumen of the annular cutter 182 ' is slightly enlarged to be substantially equal to the diameter of the central extent 16 plus twice the thickness of the Bowman's membrane 28 (e.g. 2 x 100 microns) .
  • the annular cutter 182 ' simply shaves off the excess donor material 193 from the tabs 24 while leaving the Bowman's membrane 28 of the tabs 24 intact with the Bowman's membrane 28 of the central extent 16 (see Figs. 18D and 18E) .
  • the hand support 110' together with the tab shaver punch 194 may be removed from the base support 106'.
  • the die-cut, and shaved, donor material 14 may be removed from the male die 190, and is ready for transplantation according to the surgical method of the invention described above.
  • FIGs 19A-19C illustrate an apparatus (or tool) used for preparation of the donor material 102 ( Figure 2) according to an embodiment of the instant invention.
  • a base 201 is provided to support the tool.
  • Guide pins 207 extending up from the base 201 support a punch base 202.
  • a punch 208 (similar in design to the male die of the out cutter assembly 104 of Figs. 9A-9C) is held in place within the punch base 202.
  • the punch 208 (shown in greater detail in Figure 19C) has a shape corresponding to that of the top surface of the donor material to be prepared.
  • the surface on the top end of the punch has a concave spherical radius at its center portion 806 and tabbed portions 802 extending radially from a central axis of the system and the punch corresponding to the tabbed portions of the donor material.
  • a nest 203 having a centrally located nest hole 310, also having a shape corresponding substantially to the desired axis end is adapted to receive the punch 208 in the next hole 310.
  • the nest 203 has guide holes 312 located on the periphery of the nest in order that the periphery of the punch 208 fits closely within the nest hole 310 .
  • a die 204 is aligned along the central axis to be positioned above the nest 203 and guided by guide pins 207.
  • the die also has a hole 410 centrally located which corresponds to the shape of the donor material.
  • the die 204 (similar in design to the female die of the outline cutter assembly 104 of Figs. 10 and 10B) is provided to cut through the donor material to prepare a donor blank as more fully described below.
  • the central portion 411 of the die 204 is illustrated in greater detail in Figure 19B. Portions of an upper surface of the central portion 411 of the die 204 act as a lower scalpel guide 401. The operation of the scalpel guide will be more fully explained below.
  • the die 204 is adapted to receive the punch 208 such that the extending tabbed portions 802 (Figure 19C) of the punch 208 are received by the recessed portions 402 of the die 204.
  • the die 204 also includes guide holes 412 ( Figure 19A) which are adapted to receive the guide pins 207 for alignment.
  • a bottom portion of die 204 which defines the periphery where it intersects the hole 410 acts as a cutting edge 422 in combination with a cutting edge 822 of the punch 208 which is defined by the intersection of the surfaces 802 and 806 and the vertical outside surface 824 of the punch 208.
  • the peripheral clearance between the punch 208 and the die 204 at the recessed portions 402 should not exceed 0.0001" .
  • a hollow guide member 205 is adapted to be aligned by the guide pins 207 via guide holes 513.
  • a downwardly extending cylindrical portion 514 of the hollow guide member 205 includes a bottom end 510 adapted to engage and rest on a portion of the top surface of the die 204.
  • the hollow guide 205 also includes lateral slots 520 through a portion of the bottom end 510 which serve to form an upper scalpel guide.
  • the lateral slots 520 in the guide member 205 are aligned with the lower scalpel guide 401 ( Figure 19B) of the die 204.
  • a round trephine 206 having a round cutting edge 601 on a bottom end thereof is received by the guide member 205.
  • the guide member 205 serves to guide the punch 208 after the die 204 has been used to prepare the donor blank.
  • the trephine 6 is used to make a circular cut into the donor blank as more fully described below.
  • the cutting edge of the round trephine 206 extends through the guide member 205 and out the bottom end 510 of the guide member 205, which is in contact with the die 204, and cuts into the donor material.
  • the donor material 102 is secured in place by generating a vacuum beneath the material on the punch 108.
  • the vacuum may be produced, for example, using a syringe (not shown) connected to produce a vacuum at the surface 806 ( Figure 19C) of the punch via holes 804. It is noted that during the process, the corneal end thelium cell layer should only be touched in those areas which are eventually removed and discarded.
  • the hollow guide member 205 is assembled onto the guide pins 207.
  • the hollow guide member 205 is lowered until it bottoms out (i.e., comes into contact with the top of die 204) .
  • the tabbed blank 1021 is resting on the punch 208 with a portion of the tabbed blank 1021 extending upward above the top surface of lower scalpel guide 401 of the die 204.
  • the guide 205 and the die 204 are now completely enclosed on 4 planes by the tool. Specifically, the lower surface 1032 of the tabs 1060 is supported by the punch 208.
  • the radially extending sides 1034 of the tabs 1060 are surrounded by the die 204.
  • the top portion 1036 of the tabs 1060 is enclosed by the guide member 205.
  • a round trephine 206 is inserted into the hollow guide member 205. The round trephine is lowered using an oscillating motion until it reaches its lowest point just above the Bowman's membrane 108a, 1062. At its lowest point, the trephine 206 cuts into the stroma between the tabs 106 and the central portion 103 of the donor tabbed blank 201 down to the Bowman's membrane 108a as illustrated in Figures 20 and 21C. Specifically, an incision (or slit) 1061 is made into the tabbed blank 1021 leaving a portion 1062 of the donor material beneath the incision intact.
  • the thickness of the intact portion 1062 is equal to the desired thickness of the tabs 106 ( Figure 21D) .
  • the trephine 6 is left in place such that the tab stroma is now confined on a fifth of the six possible planes by the blade of the trephine as illustrated in Figure 20.
  • the scalpel 209 positioned by the lateral slots 520 of the guide 205 forming the upper scalpel guide and the lower scalpel guide 401 of the die 204, the stroma of the tab is cut away from the Bowman's membrane 108a of the donor blank 1021.
  • the scalpel 209 is used to trim the undesired portion of the donor blank 1021 using the scalpel guide and trephone 206 lend as support for the donor material as illustrated in Figure 20.
  • the resultant donor material now has the desired shape as illustrated in Figure 21D including thin tabbed portions 106.
  • the scalpel 209, the round trephine 206 and the guide 205 are removed.
  • the donor material 102 may then be removed from the die 204 and has the shape illustrated in Figure and 21D.
  • the donor material is placed into the recipient's eye as illustrated in Figure 18.
  • the various methods of the invention as described above preferably include the step of forming a barb 1010 in the tabs 24 by means of a tweezer punch 1001 or other tool (see Figs. 22A-22C and 23A-23B) .
  • a preferred embodiment of a tweezer punch 1001 includes a conventional tweezer design with handle 1002 and opposing tongs 1003 and 1004 biased apart from each other as shown in Fig. 22A. As best shown in Figs.
  • the distal end of one of the tongs such as 1003 includes an inwardly protruding punch 105 having a generally triangular configuration in cross-section as well as in planar view.
  • the other tong such as 1004 includes die hole 1006 having a generally triangular planar configuration.
  • cutting action is created along the cutting edges 1007 of the die hole 1006 but not along fold edge 1008. Accordingly, it should be appreciated that upon placement of material between the tongs 1003 and 1004 of the tweezer 1001 and squeezing of the tweezer 1001, the punch 1005 will form an outwardly extending barb 1010 in the material defined by cutting edges 1007 and fold edge 1008.
  • the tweezer punch 1001 may be used to form barbs 1010 on the outer or inner surfaces of one or more or all of the tabs 24 of the donor material 14.
  • barb 1010 is composed of the Bowman's membrane 28 and therefore serves to more securely retain the tabs 24 into their respective pockets 46 once they are imbricated therein.
  • the Bowman's membrane 28 constituting the barb 1010 is squeezed of a certain amount of moisture and dries to a certain degree, thereby desirably becoming more rigid and thus functioning even better as a barb 1010.
  • the pockets 46 of the recipient eye 10 are preferably formed further interiorly to provide sufficient room for the barbs 1010 once imbricated therein without causing bulging of the Bowman's membrane 28 of the recipient eye 10 as could occur if the pockets 46 were formed immediately under the Bowman's membrane as illustrated in Fig. 3.
  • the barbs 1010 may be formed to extend outwardly from the outer surface of the Bowman's membrane, from the inner surface of the Bowman's membrane, or a mixed combination thereof as shown in Figs. 23A and 23B.

Abstract

L'invention concerne un appareil et un procédé permettant de préparer une cornée de l'÷il d'un donneur et la transplanter dans l'÷il d'un receveur avec un minimum de suture, voire sans suture. La matière cornéenne du donneur est découpée suivant une configuration circulaire avec des pâtes (24) positionnées symétriquement, de préférence en forme de diamant, et s'étendant radialement depuis la périphérie (18) de l'étendue centrale (16), les pâtes étant constituées uniquement de la membrane de Bowman (28) comme prolongement de la membrane de Bowman de l'étendue centrale. L'÷il receveur (10) est coupé à l'aide d'une tréphine afin de former une ouverture circulaire (38) dans la cornée, au niveau de sa partie centrale, l'ouverture circulaire ayant une dimension et une forme correspondant essentiellement à la périphérie de l'étendue centrale de la matière cornéenne du donneur, l'ouverture ayant une épaisseur commune au niveau de la périphérie de l'ouverture, la partie centrale ayant un nombre correspondant de poches (46) positionnés symétriquement. L'étendue centrale de la matière cornéenne du donneur est positionnée dans l'ouverture ménagée dans l'÷il du receveur, puis les pâtes de l'étendue centrale sont imbriquées dans les poches respectives de l'÷il receveur, fixant ainsi la cornée transplantée du donneur dans l'÷il du receveur.
PCT/US1995/013932 1994-08-12 1995-10-26 PROCEDE ET APPAREIl DE TRANSPLANTATION SANS SUTURE D'UNE CORNEE Ceased WO1996013215A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU40144/95A AU4014495A (en) 1994-08-12 1995-10-26 Sutureless corneal transplantation apparatus and method

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US08/289,670 US5584881A (en) 1994-08-12 1994-08-12 Sutureless corneal transplantation apparatus and method
US08/329,709 1994-10-26
US08/329,720 1994-10-26
US08/329,720 US5755785A (en) 1994-08-12 1994-10-26 Sutureless corneal transplantation method
US08/329,709 US5649944A (en) 1994-08-12 1994-10-26 Apparatus for preparing cornea material for tabbed (sutureless) transplantation

Publications (2)

Publication Number Publication Date
WO1996013215A1 WO1996013215A1 (fr) 1996-05-09
WO1996013215A9 true WO1996013215A9 (fr) 1996-07-18

Family

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Country Status (2)

Country Link
AU (1) AU4014495A (fr)
WO (1) WO1996013215A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ304908B6 (cs) * 2013-05-24 2015-01-14 Pavel StodĹŻlka Trepan pro transplantaci rohovky

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4077411A (en) * 1975-04-18 1978-03-07 Ward Donald E Keratoplasty device
US4842599A (en) * 1986-10-28 1989-06-27 Ann M. Bronstein Prosthetic cornea and method of implantation therefor
US5215104A (en) * 1988-08-16 1993-06-01 Steinert Roger F Method for corneal modification
US5334213A (en) * 1993-10-15 1994-08-02 Price Jr Francis W Corneal press

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