Patent Publication Number: US-2021177574-A1

Title: Methods for small incision eye surgery

Description:
RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 16/288,355, filed Feb. 28, 2019, which is a divisional of U.S. patent application Ser. No. 15/229,695, filed Aug. 5, 2016, now U.S. Pat. No. 10,258,461, issued Apr. 16, 2019, which is a continuation of U.S. patent application Ser. No. 14/162,351, filed Jan. 23, 2014, now U.S. Pat. No. 9,433,495, issued Sep. 6, 2016, which is a continuation of U.S. patent application Ser. No. 13/901,115, filed May 23, 2013, now U.S. Pat. No. 8,673,002, issued Mar. 18, 2014, which is a continuation of U.S. patent application Ser. No. 11/626,959, filed Jan. 25, 2007, now U.S. Pat. No. 8,470,029, issued Jun. 25, 2013, which claims the benefit of priority of U.S. Provisional Application Ser. No. 60/762,452, filed Jan. 26, 2006, U.S. Provisional Application Ser. No. 60/788,221, filed Mar. 31, 2006, and U.S. Provisional Application Ser. No. 60/865,045, filed Nov. 9, 2006, the contents of which are hereby incorporated by reference as if recited in full herein. 
    
    
     FIELD OF THE INVENTION 
     The invention relates to tools that facilitate corneal surgeries to implant donor tissue. 
     BACKGROUND OF THE INVENTION 
     Conventional corneal transplantation surgery, also known as penetrating keratoplasty, uses full-thickness corneal replacement with sutures. Recently, deep lamellar endothelial keratoplasty (DLEK) has been used to place a partial-thickness corneal replacement from a healthy donor cornea into a host/recipient along with its endothelium. DLEK is also known as “stitchless” corneal transplantation. 
     Some researchers and physicians believe that DLEK is a major advance in the way that diseased human cornea is replaced with healthy donor corneal endothelium. An exemplary transplantation procedure of a conventional donor harvesting and recipient preparation is described in Thomas John,  Stitchless Corneal Transplantation , Cataract &amp; Refractive Surgery Today, pp. 27-30, August 2004. As described, a donor corneal endothelium is coated with viscoelastic material and the cornea and its attached scleral rim are placed in an artificial chamber. After excision of the anterior stromal disc, the donor corneal stroma can be flipped on itself so that the donor corneal stroma rests on a Teflon® block with the stromal side facing down and is held in place via vacuum. Trephination can be carried using a MORIA trephine. The deep stromal-endothelia donor disc can be carefully placed onto a viscoelastic-coated Ousley spatula (available from Bausch &amp; Lomb) with the endothelial side facing down. 
     More recently, a smaller incision DLEK technique has been proposed in which the donor disc (usually between about 8-8.25 mm in diameter) can be held by simple forceps. In this procedure, the surgeon folds the transplant in half (endothelial side down) and inserts the transplant material through a 5 mm incision into the host anterior chamber (under air) and onto the host bed of the pre-resected central area. Instrastromal Cindy scissors can be used in a free hand manner to excise the recipient disc using about an 8 mm circular ink mark on an epithelial surface as a visual template. A separate tool is typically used to manipulate the tissue into position. Once in the anterior chamber, the folded donor disc is irrigated with saline to remove viscoelastic material, opened further with an air bubble (which can be decreased in size), then rolled over the air bubble, thereby placing the donor stromal surface into contact with the recipient stromal bed for self-adhesion. Staining of the donor disc can help a surgeon properly align the disc in the host bed. A reverse Sinskey hook can be used for final positioning to tuck the donor edges anterior to the recipient bed edges to inhibit later dislodgement. See, Terry et al.,  Small Incision Deep Lamellar Endothelial Keratoplasty  ( DLEK )  Six Month Results in the First Prospective Clinical Study , Cornea, Volume 24, No. 1, pp. 59-65, January 2005. 
     Despite the foregoing, there is a need to provide surgical instruments that can facilitate DLEK or stitchless corneal transplantation. 
     SUMMARY OF EMBODIMENTS OF THE INVENTION 
     Embodiments of the present invention are directed to devices and methods that can facilitate small incision DLEK and/or stitchless corneal transplantation. 
     Some embodiments are directed to methods of configuring a deep stromal endothelial donor corneal disc (graft) for transplantation. The methods include: (a) providing a corneal transplantation donor disc; and (b) rolling the disc into a compact implant configuration. 
     In some methods, the donor disk may have a diameter of between about 8 mm to about 8.25 mm. The donor disc compact configuration may have a cross-sectional width that is less than about 3 mm (for example, about 2.5 mm) suitable for entering a scleral access incision sized at less than about 4 mm (for example, about 3 mm). 
     In particular embodiments, the provided corneal donor disc has a first unrolled generally planar configuration and the method can include: (a) providing a rolling tool having first and second cooperating members that define a gap space therebetween; (b) inserting a portion of the planar donor disc between the first and second cooperating members; (c) forcing the first and second members together to trap a portion of the donor disc therebetween; then (d) rotating the rolling tool to roll the donor disc about itself. 
     Other embodiments are directed to surgical transplant donor corneal disc kits. The kits include a rolled partial thickness donor corneal transplant disc held in a sterilized package. 
     Yet other embodiments are directed to systems for performing small incision DLEK. The systems include: (a) a rolled donor graft disc for endothelial replacement surgery; and (b) a rolled disc delivery device for releasably holding the rolled disc for surgical introduction in a recipient stromal bed via a small incision access site. 
     Some embodiments are directed to methods of configuring a deep stromal endothelial donor corneal tissue graft for transplantation. The methods include: (a) providing a corneal transplantation donor tissue graft; (b) optionally placing the donor tissue graft on a flexible substrate; and (c) forming the donor tissue graft into a compact implantable configuration using the flexible substrate. 
     In some methods, the donor disk may have a diameter of between about 8 mm to about 9 mm. The donor disc compact configuration may have a cross-sectional width that is less than about 3 mm (for example, about 2.5 mm) suitable for entering a scleral access incision sized at less than about 4 mm (for example, about 3 mm). 
     Some embodiments are directed to surgical transplant donor corneal disc kits that include a rolled partial thickness donor corneal transplant disc held on a flexible substrate in a sterilized package. 
     In some embodiments, the kit can include a lubricant material disposed about the rolled disc and the kit may also include a disc-holding member configured to releasably hold the rolled disc. 
     Other embodiments are directed to corneal donor disc medical tools that include: (a) a holding member with a holding chamber having a wall; and (b) a flexible substrate in cooperating relationship with the holding chamber. The flexible substrate is configured to slidably enter the holding chamber and hold a corneal donor tissue graft in the holding chamber in a rolled configuration. 
     The flexible substrate and/or the holding chamber can be configured to inhibit rotation of the tissue graft in the chamber so that a user can control orientation of the stroma and endothelial sides of the implant. The tool can be single-use disposable. 
     Some embodiments are directed to donor harvesting tool kits that optionally include a flexible substrate. The kit holds a donor corneal grafting disc in a rolled configuration for small incision DLEK. The donor disc can have a diameter between about 8-9 mm and a thickness between about 100-200 μm. 
     Still other embodiments are directed to medical products with a rolled donor corneal disc held on a flexible substrate for performing a small incision DLEK. 
     Some embodiments are directed to systems for use in small incision DLEK. The systems include: (a) a rolled donor graft disc for endothelial replacement surgery; and (b) a rolled disc delivery device for releasably holding the rolled disc for surgical introduction in a recipient stromal bed via a small incision access site. 
     Some embodiments are directed to donor harvesting tools configured to releasably engage and form a donor corneal grafting disc having a diameter between about 8-9 mm and a thickness between about 100-200 μm (typically about 150 μm) into a rolled configuration for small incision “stitchless” or self-healing DLEK. The harvesting tool can also be used as the implantation tool (i.e., a dual-use single device). The donor disk may be held on a flexible substrate during surgical delivery. 
     Other embodiments are directed to methods for delivering donor tissue to an implantation site. The methods include: (a) holding the donor tissue in a rolled configuration on a flexible substrate in a cannula; (b) positioning the cannula at the target implantation site; then (c) slidably retracting the cannula and the flexible substrate away from the implantation site, thereby releasing the donor tissue at the implantation site. 
     Additional embodiments are directed to other methods for delivering donor tissue to an implantation site. The methods include: (a) holding the donor tissue in a rolled configuration in a cannula; (b) positioning the cannula at the implantation site; then (c) pushing the donor tissue out of the cannula (typically by contact with a pushing member and/or fluid), thereby releasing the donor tissue proximate the implantation site. 
     It is noted that any of the features claimed with respect to one type of claim, such as a system, apparatus, or computer program, may be claimed or carried out as any of the other types of claimed operations or features. 
     Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the embodiments that follow, such description being merely illustrative of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a schematic illustration of a medical tool according to embodiments of the present invention. 
         FIG. 1B  is a schematic illustration of the device shown in  FIG. 1A  showing the flexible substrate and tissue graft being retracted into a holding chamber according to embodiments of the present invention. 
         FIG. 2  is a greatly enlarged cross-sectional view of the device shown in  FIGS. 1A and 1B  with a fully retracted flexible substrate with tissue graft according to some embodiments of the present invention. 
         FIG. 3  is a flow chart of operational steps that may be taken to carry out embodiments of the present invention. 
         FIGS. 4A-4C  are exemplary cross-sectional views taken along lines  4 - 4  in  FIG. 5 . 
         FIG. 5  is a partial side view of the device shown in  FIGS. 1A and 1B . 
         FIG. 6  is a schematic side view of the device shown in  FIG. 5  illustrating an implant orientation of the tissue graft in the device according to some embodiments of the present invention. 
         FIGS. 7A-7C  are side views of flexible substrates for receiving donor tissue during a harvesting procedure according to some embodiments of the present invention. 
         FIGS. 8A and 8B  are partial top views of exemplary flexible substrate configurations with releasable and integral arms, respectively, according to embodiments of the present invention. 
         FIGS. 9A-9C  are top schematic views of exemplary flexible substrate configurations according to embodiments of the present invention. 
         FIG. 10A  is a schematic top view of a flexible substrate with a collar according to some embodiments of the present invention. 
         FIG. 10B  is a lateral section view of an anti-rotation configuration of the collar shown in  FIG. 10A  according to some embodiments of the present invention. 
         FIG. 10C  is a partial longitudinal section view of an anti-rotation configuration to inhibit rotation of the substrate in the chamber according to embodiments of the present invention. 
         FIG. 10D  is a lateral cross-sectional view of the device shown in  FIG. 10C  illustrating a fin channel. 
         FIG. 11A  is a schematic partial top view of another flexible substrate configuration according to embodiments of the present invention. 
         FIG. 11B  is a greatly enlarged partial side view of a tissue graft on the flexible substrate shown in  FIG. 11A  according to some embodiments of the present invention. 
         FIG. 12  is a schematic partial top view of a holding device configured to allow a user to view internal objects to visually confirm a desired orientation of the transplant tissue graft according to embodiments of the present invention. 
         FIG. 13  is a schematic partial side view of a 2-way action medical tool according to some embodiments of the present invention. 
         FIG. 14  is a schematic partial side view of a one-way action medical tool according to other embodiments of the present invention. 
         FIG. 15  is a schematic side view of a medical tool with a cooperating flexible substrate according to embodiments of the present invention. 
         FIG. 16  is a schematic illustration of an exemplary donor harvest medical kit according to embodiments of the present invention. 
         FIG. 17  is a schematic illustration of an exemplary medical kit with a rolled donor disc preformed and ready for implantation according to other embodiments of the present invention. 
         FIGS. 18A and 18B  are partial top views of the device shown in  FIG. 1A  illustrating that the device may include visual orientation and/or alignment indicia according to embodiments of the present invention. 
         FIGS. 19A and 19B  are perspective views of a flexible substrate showing that the flexible substrate can be used to hold the donor tissue graft with other medical tool configurations according to embodiments of the present invention. 
         FIGS. 20A-20C  are schematic perspective views of a medical tool that can be used to hold and/or deliver donor disc tissue according to embodiments of the present invention. 
         FIG. 21  is a schematic of an enlarged partial perspective view of the device shown in  FIGS. 20A-20C . 
         FIG. 22  is a schematic illustration of a medical kit according to embodiments of the present invention. 
         FIG. 23  is a diagram of a data processing system that can be used to electronically assist and/or control fluid pressure for delivery of the donor disc according to some embodiments of the present invention. 
         FIG. 24A  is a side perspective view of a medical rolling tool according to embodiments of the present invention. 
         FIG. 24B  is an end view of the device shown in  FIG. 24A  illustrating a gap space between upper and lower members according to some embodiments of the present invention. 
         FIG. 25A  is a side perspective view of the device shown in  FIG. 24A  illustrating the device rolling a donor disc according to embodiments of the present invention. 
         FIG. 25B  is an end view of the device shown in  FIG. 25A , illustrating the upper and lower members abutting each other according to some embodiments of the present invention. 
         FIGS. 26 and 27  are side perspective views of the device shown in  FIGS. 24A and 25A  illustrating a sequence of operations used to roll the disc into a surgical preparation form according to embodiments of the present invention. 
         FIG. 28  is a side view of an exemplary surgical rolled donor disc according to embodiments of the present invention. 
         FIG. 29  is a side perspective partial cutaway view of the tool and rolled disc of  FIG. 27  being placed in a surgical delivery tool according to some embodiments of the present invention. 
         FIG. 30  is a side partial cutaway view of the tool shown in  FIG. 29  illustrating the rolled donor disc held therein according to embodiments of the present invention. 
         FIG. 31  is a side partial cutaway view of the tool shown in  FIG. 30  illustrating the donor disc being expelled from the chamber of the delivery device according to some embodiments of the present invention. 
         FIG. 32A  is a top view of the device shown in  FIG. 31 . 
         FIG. 32B  is an end view of the device shown in  FIG. 32A . 
         FIG. 33  is a schematic illustration of the device and rolled donor disc being delivered to a recipient stromal bed to carry out a small incision DLEK according to embodiments of the present invention. 
         FIG. 34  is a schematic illustration of an exemplary medical kit with a rolled donor disc held by the rolling tool according to embodiments of the present invention. 
         FIG. 35  is a schematic illustration of another exemplary medical kit with a rolled donor disc according to other embodiments of the present invention. 
         FIG. 36  is a schematic illustration of yet another medical kit with a rolled corneal donor disc with a holding chamber according to embodiments of the present invention. 
         FIG. 37  is a schematic illustration of yet another medical kit with a rolled corneal donor disc and delivery system according to embodiments of the present invention. 
         FIG. 38  is a side cutaway view of another delivery device for a rolled disc according to other embodiments of the present invention. 
         FIG. 39  is a side perspective partial cutaway view of the device shown in  FIG. 29  illustrating that visual alignment indicia may be used according to embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. 
     Like numbers refer to like elements throughout. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. Broken lines illustrate optional features or operations unless specified otherwise. Features described or shown with respect to one embodiment may be used with a different embodiment. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. As used herein, phrases such as “between X and Y” and “between about X and Y” should be interpreted to include X and Y. As used herein, phrases such as “between about X and Y” mean “between about X and about Y.” As used herein, phrases such as “from about X to Y” mean “from about X to about Y.” 
     Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity. 
     It will be understood that when an element is referred to as being “on”, “attached” to, “connected” to, “coupled” with, “contacting”, etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on”, “directly attached” to, “directly connected” to, “directly coupled” with or “directly contacting” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature. 
     It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise. 
     The term “rolled” and derivatives thereof refer to turning or coiling the donor tissue about an axis into a substantially rolled configuration, thus inhibiting the formation of sharp fold edges. The terms “small opening” or “small incision” means an opening that is less than about 5 mm wide and/or long, typically about 3 mm. The term “compact configuration” means that the donor disc is configured smaller than its end use configuration by at least about 40%, typically less than about 50%. For example, if the end use configuration is about an 8.25 mm diameter or width, then the compact configuration can provide a width that about or less than about 5 mm, typically about or less than 4 mm. In some configurations, the compact configuration can be about 60% less than the use or normal width, such as about 3 mm or less, and may be about 2.5 mm. 
     Turning now to the figures,  FIG. 1A  illustrates a medical tool  10  and a donor tissue graft implant  25 . The donor implant is typically a disc such as a posterior lamellar keratoplasty transplant (PLK), although other tissue grafts, particularly fragile tissue grafts, may be suitable for forming and/or delivery using devices/methods described herein. As shown in  FIG. 1A , in some embodiments, the tool  10  can cooperate with a flexible substrate carrier  15  that holds the implant  25 . The holding portion  15   e  of the flexible substrate  15  can be configured to have a substantially planar shape outside the tool  10 . 
     As shown in  FIGS. 1B and 2 , the tool  10  has a cavity  10   c  that is configured to slidably receive a flexible substrate carrier  15  that holds the donor disc  25 . As shown in  FIG. 1B , as the flexible substrate  15  enters (is retracted, withdrawn and/or pulled into) the tool cavity  10   c , the outer edges of the flexible substrate  15   a ,  15   b  are pushed upward and can also be forced to travel closer together, thereby forming the donor implant  25  into a smaller, typically compact, configuration using the flexible substrate  15 . The flexible substrate can be conformable so as to substantially conform to the shape of the cavity wall  10   w . As the flexible substrate  15  takes on a compact configuration, it forces the tissue graft  25  into a smaller, compact configuration. 
     As shown in  FIG. 2 , the flexible substrate  15  can be pushed, folded, wrapped or bent, and is typically formed to have a curvilinear cross-sectional shape  25   c  with the two opposing edge portions spaced apart to define an open center space  25   g . However, the flexible substrate  15  and donor tissue graft  25  can be formed into other shapes. The compact tissue graft shape can be a rolled shape without sharp fold creases, corners or edges. As shown, the curvilinear shape  25   c  can be substantially oval with rounded lateral edges. The cavity  10   c  can have a width W that is between about 3-6 mm, typically between about 3.5 mm to about 4 mm. The outside diameter (OD) of the disc in the shaped configuration  25   c  can be between about 2.5 mm to about 3 mm, typically about 2.87 mm for a 9 mm graft. The inside diameter (ID) of the shaped disc  25   c  can be between about 0.1 mm to about 0.5 mm less than the OD, depending on thickness of the graft  25 . For the 2.87 mm OD and a tissue graft having a thickness of about 150 μm, the ID can be about 2.84 mm. 
       FIG. 3  illustrates operational steps that can be used to configure a deep stromal endothelial donor corneal disc for transplantation. A corneal transplantation donor tissue graft can be provided (block  70 ). The tissue graft can optionally be placed on a flexible substrate (block  75 ), then the tissue graft can be formed into an implantable configuration using the flexible substrate (block  80 ). The forming can be carried out substantially (if not totally) without endothelial cell trauma.  FIG. 33  illustrates an exemplary target implantation site. 
     In some embodiments, the tissue graft has an endothelial side and an opposing stromal side, and the placing step is carried out so that the stroma side faces the flexible substrate with the endothelial side facing up (block  76 ). The holding member can be rotated so that the stromal side is facing upward and the endothelial side is facing downward before inserting the tissue graft into a patient&#39;s target anterior chamber (block  77 ). 
     In some embodiments, the tissue graft can be retracted on the flexible substrate into a holding member with a cavity, the cavity having a cross-sectional width that is less than that of the flexible substrate and tissue graft, whereby the retracting step forces the flexible substrate into the formed tissue graft implantable configuration (block  78 ). In other embodiments, a supplemental tool can help form the substrate and disc into a compact configuration, independent of, outside of and/or in cooperation with the holding member. The forming can include rolling the flexible substrate and tissue graft responsive to the retracting step (block  79 ). 
     The flexible substrate  15  can be formed from a unitary layer of biocompatible material or laminated layers of biocompatible materials. The flexible substrate  15  can comprise any suitable biocompatible material, such as elastomer, polymer, and copolymer materials and/or derivatives thereof, mylar, foil and the like, and/or combinations thereof. Biocompatible non-stick and/or antifriction coatings may be used. The flexible substrate  15  can include a first anti-friction coating on one primary surface and a different coating on the tissue-contacting surface. The flexible substrate  15  can be a thin-film substrate. 
     As shown in  FIG. 2 , the flexible substrate  15  can be thinner than the tissue graft  25 . In some embodiments, the flexible substrate  15  is less than half the thickness of the graft  25 . In particular embodiments, the flexible substrate  15  can be between about 1-200 μm thick, and more typically between about 10-100 μm thick. 
     As shown in  FIGS. 4A-4C , the curvilinear formed tissue graft shapes  25   c  and flexible substrate  15  can be configured so that respective opposing edges are spaced apart with gaps  25   g ,  15   g  axially extending about a medial portion of the holding member cavity  10   c  as shown in  FIG. 4A . Alternatively, the substrate edges  15   a ,  15   b  may contact and even overlap as shown in  FIG. 4B . Optionally, as shown in  FIG. 4C , the disc  25  may be rolled so that one edge  25   a  is under the other edge  25   b . It is noted that the cross-sectional shape of the holding cavity  10   c  is shown in  FIGS. 2 and 4A-4C  as being substantially oval or circular; however, the instant invention is not limited thereto. Other geometric shapes may also be employed, such as, for example, pentagonal, hexagonal, square, rectangle, triangular, and the like. 
       FIG. 5  is a side view of the holding device  10  with the formed disc  25  on the flexible substrate  15 . As shown, the device  10  includes an angled or tapered forward edge portion  10   e  to facilitate insertion into the anterior chamber during implantation and/or delivery. The height H of the cavity  10   c  can be between about 3-6 mm, typically between about 3.5 mm to about 4 mm.  FIG. 5  also illustrates that a plunger  50  can be disposed upstream of the formed disc  25 . Fluid from the plunger  50  and/or the plunger itself can be used to expel the tissue graft  25  from the cavity during surgical placement. Other irrigation delivery configurations may also be used. In some embodiments, the flexible substrate  15  is retained in the holding device  10  during delivery of the tissue graft  25 . In other embodiments, the flexible substrate  15  can be advanced with the disc during transplant placement in the eye. 
       FIG. 6  illustrates that the device  10  can have a harvest configuration and a delivery configuration with different orientations for holding and releasing, respectively, the transplant tissue  25 . As shown, it is typically desirable to have the endothelium side of the tissue facing upward and the stromal side oriented (facing) down during harvest or preparation, and to reverse the orientation for ease of placement upon release of the implant from the cavity  10   c . As the implant leaves the cavity  10   c  (after the device is inserted into a small incision proximate the target anterior chamber bed), the disc  25  is no longer constrained by the wall of the device  10  and can automatically unfold or unroll to a substantially planar configuration with the stroma side facing up. 
       FIGS. 7A-7C  illustrate exemplary configurations of the flexible substrate  15  when obtaining the donor tissue grant from a harvesting procedure. The donor tissue graft  25  can be placed on the substrate  15  when the carrier substrate is in the substantially planar configuration ( FIG. 7A ). In other embodiments, the carrier substrate  15  may be configured to have a concave or convex curvature as shown, for example, in  FIGS. 7B and 7C , respectively. The donor graft  25  can be placed on an upper surface of the substrate  15 , then formed into a more compact configuration. If concave or convex configurations are used, the forming may follow the direction of the curvature. For example, the outer edges  15   a ,  15   b  can be pushed upward for the configuration shown in  FIG. 7B  and the outer edges  15   a ,  15   b  can be pushed downward in the embodiment shown in  FIG. 7C . 
       FIG. 8A  illustrates that the flexible substrate  15  can be attached to an arm  16 . The arm  16  can be rigid or have increased rigidity with respect to the flexible substrate  15 . The arm  16  can be releasably attached to the substrate  15  or fixedly attached to the substrate  15 .  FIG. 8B  illustrates that the flexible substrate  15  can include an integral, rearwardly extending arm  15   r  that extends away from the forward holding portion of the substrate  15   e . The arm  15   r  may be attached to a stiffener member or may be laminated or otherwise structurally reinforced for increased rigidity. The arm  15   r ,  16  can engage the flexible substrate  15  and be used to pull the substrate into the cavity of the tool  10 . 
     Typically, the donor disc  25  is placed on a first (upper) surface of the flexible substrate  15  with the stroma side contacting the substrate  15 . The substrate  15  is then retracted into the holding cavity  10   c . The device  10  is rotated, typically about 180 degrees, to place the stroma side up, with the endothelium side facing down. The end of the device  10   e  can be inserted into the eye&#39;s anterior chamber and the tissue ejected, expelled or otherwise released. 
       FIGS. 9A-9C  illustrate exemplary flexible substrate end portion (paddle) configurations  15   e . As shown in  FIG. 9A , the flexible substrate  15  can have an elongate body with a rounded arcuate forward edge portion  15   e  that merges into two parallel side portions. As shown in  FIG. 9B , the flexible substrate forward edge portion  15   e  can be substantially circular, and as shown in  FIG. 9C , the forward edge portion  15   e  can be rectangular. The flexible substrates  15  can include visual alignment indicia  18  for facilitating proper placement during the harvesting procedure. 
     In some embodiments, the holding device  10  can be configured to inhibit rotation of the flexible substrate  15  inside the cavity  10   c  to positively control and maintain the orientation of the flexible substrate  15  as the tissue  25  is retracted and/or advanced. In this arrangement, the stromal and endothelial sides are known and controlled, oriented to a user&#39;s control, and/or positioned so that the orientation for placement can be easily determined or known. 
       FIG. 10A  illustrates that the flexible substrate  15  can be configured to slidably retract into the tool body  10 . The substrate  15  can be attached to a collar  155  that can be angled and configured to slide in a single controlled orientation within the cavity  10   c  during advancement and retraction. In some embodiments, the substrate  15  can communicate with the collar  155  to inhibit rotation inside the cavity  10   c  and to allow the substrate  15  to translate axially only in the retraction direction. As shown in  FIG. 10B , the collar  155  can receive the plunger  50  and allow the plunger  50  to advance without advancing the flexible substrate  15 . In other embodiments, the substrate  15  can advance with the plunger  50  and/or fluid to help position the disc  25  in a target location. The cross-sectional shape of the plunger  50  can also be angled to be matably received by the collar  155  to maintain the orientation of the plunger  50  with respect to the flexible substrate  15  and/or cavity  10   c . The plunger  50  may include fluid apertures (not shown) and/or fluid may enter in advance of the plunger  50  and/or via the gap spaces between the plunger  50  and collar  155 . The plunger  50  and/or fluid can be introduced over or under the arm  15   r  to force the donor disc  25  from the cavity  10   c  with the flexible substrate  15  remaining in the cavity  10   c.    
       FIG. 10C  illustrates an alternate exemplary anti-rotation configuration of the flexible substrate  15 . As shown, the flexible substrate  15  can include at least one fin  15   f  (shown as two) that can slide in a mating channel/recess  10   ch  ( FIG. 10D ) in the wall  10   w  of the tool  10 . The channel or recess  10   ch  may alternatively reside in the substrate collar  155  or other component rather than in the wall of the device. 
       FIG. 11A  illustrates that the flexible carrier substrate  15  can include a well  19 . The well  19  can be a depression formed in the substrate  15  or an aperture. The well  19  can reduce surface tension to facilitate the ability of the flexible substrate  15  to roll or wrap to a compact configuration.  FIG. 11B  illustrates the donor tissue graft  25  placed over the well  19  prior to rolling or forming. 
     As noted above, the plunger  50  can be configured to advance based on pressurized fluid and/or rod actuation. If pressurized fluid alone is used, no separate plunger arm or plunger arm channel is required (not shown). In any event, where a plunger  50  is employed, the plunger  50  may be configured directly (gently) contact a trailing edge of the rolled disc  25   c , or may be configured to push indirectly, such as by pushing an intermediate fluid such as a gel (comprising, for example, a viscoelastic material) forward, thereby pushing the disc forward. 
     Alternatively, fluid can be introduced into the chamber  10   c  and directed to flowably expel the disc  25   c  ( FIG. 2 ) into position in the anterior chamber. The plunger  50  can be advanced to help expel the disc  25   c  as needed. The delivery device  10  can include a plurality of spaced apart flow orifices (and may include micronozzles) that are configured to introduce fluid from a wall and/or from the plunger of the device into the chamber  10   c . The orifices have an associated fluid channel that can merge into the primary channel. The orifices can reside axially and circumferentially spaced apart about the chamber  10   c  or may reside substantially aligned in a rearward portion of the chamber  10   c  to help initiate the expellant flow force onto the disc  25   c . The orifices may be configured as flushing ports that can expel pressurized fluid generally inward and axially forward. Alternatively, the orifices can be configured to emit fluid under lesser pressures to inhibit adhesion to the chamber walls. 
       FIG. 12  illustrates that the holding member  10  can be configured to allow a user to view internal components to observe orientation of the graft and/or withdrawing, retracting, rolling and/or advancing action to visually confirm orientation of the graft  25 . The holding member  10  itself can be visually transmissive, such as transparent or translucent, or may include at least one viewing window. If the latter, there are typically at least two viewing windows, spaced apart so that one resides above the other. As shown, a first viewing window  10   w  (illustrated by the cross-hatch markings) can axially extend over at least a major portion of the length of the tissue graft  25 , typically a substantial length and with a width sufficient to allow a clinician to verify that the endothelial side is in position for implantation. 
     The tool  10  can be a multi-purpose, bidirectional tool that receives donor tissue, forms the donor tissue, holds the donor tissue, then is used to surgically deliver (expel) the donor implant  25 . 
     It is contemplated that rolling the donor disc  25  can reduce damage to the donor endothelium over folded configurations and/or provide for smaller entry configurations. The donor disc  25  can have a typical use diameter that is between about 8.0 mm to about 9.0 mm, typically between about 8.0 mm to about 8.25 mm; however, other suitable diameters may be used. The disc  25  may also have a thickness that is typically between about 100-300 μm thick, and more typically between about 100-200 μm thick. 
       FIG. 13  illustrates that the plunger  50  and/or flexible substrate  15  can be configured to operate with two-way action, while  FIG. 14  illustrates that the plunger  50  (and/or flexible substrate  15 ) can operate with one-way action. For the latter, the plunger  50  can translate to extend, whereas the flexible substrate  15  can translate to retract. Each may have a collar or other stop member that defines the stroke and/or directional travel. 
       FIG. 15  illustrates a thumb handle control actuator  110  with a finger post  110   f  that can be used to operate the tool  10  during a surgical procedure. Turning the thumb handle control actuator  110  can retract the flexible substrate  15  into the tool cavity  10   c  and/or push the plunger  50  forward to expel the tissue graft  25  during surgical implantation. 
     The donor disc  25  can be extracted from the donor eye in any suitable manner. Similarly, the desired size disc of the posterior corneal stroma of the recipient eye can be resected in any suitable manner, such as by using instrastomal scissors (such as “Cindy Scissors” from Bausch &amp; Lomb). 
     Typically, the tool  10  forms the disc  25  so that the lower donor stromal surface is on the outside bottom surface of the rolled body  25   c  ( FIG. 2 ). 
     To promote reliability, efficiency and/or ease in surgical placement, it is contemplated that a standard rolled orientation will be used and/or that different medical kits noting the surgeon&#39;s desired rolled orientation can be provided. The latter can allow a surgeon to order a kit that is suitable for the particular entry incision used (which may vary depending on patient eye structure) and/or for a desired unrolling technique (side to side, top to bottom, bottom to top, offset, and the like). The rolled disc  25   r  may be configured for a temporal side or a superior entry. 
     When unrolling in situ, rather than placing the rolled disc medially in the recipient stromal bed, the rolled disc  25   r  ( FIG. 5 ) may be inserted closer to a side edge portion of the eye, the side edge portion typically being the one that corresponds to the last rolled portion. The donor disc can then be unrolled in an opposite direction using physical or fluid forces. 
     To promote increased efficiency in surgical procedures, an OEM or medical company can provide the donor disc  25  preformed in the rolled configuration  25   r  ( FIG. 5 ) and ready for surgery. The rolled disc  25   c  may be held in a refrigerated storage condition prior to end use. The disc  25  may be rolled using different end use disc sizes and provided in a preformed rolled configuration for different end use sizes (between about 8 mm to about 9 mm, including about 8.25 mm). 
     The chamber  10   c  has a length L sufficient to hold the length of the disc  25  therein, and is typically between about 8.5-10 mm long, typically about 9 mm long. As noted above, pressurized fluid can be introduced into the chamber  10   c  to urge or force the rolled disc  25   c  to exit the chamber. The fluid can comprise air, oxygen, saline, water or other suitable fluid. Where a lubricant and/or viscoelastic substance (such as HEALON from Pharmacia in Nutley, N.J.) is used to preserve or protect the rolled disc  25   r , a pre-delivery flushing may be desired to prepare the rolled disc  25   r  for surgical insertion (to remove at least some of the substance from the rolled disc  25   r  or chamber  10   c  prior to placement in the body). The open-end  10   e  may be capped or sealed prior to use to help seal the disc in a sterile environment and/or placed in a sterile sealed package. 
       FIG. 16  illustrates an example of a medical tool kit  200  that can be provided to obtain donor tissue  25 . The kit  200  includes a forming tool (holding member)  10  and a flexible substrate  15  in a sterile package  90 . The kit  200  may also include fluid  21  that can be placed on the donor tissue  25  before or after insertion into a holding member  10 . The fluid  21  can comprise a quantity of biocompatible liquid that can be placed about the disc  25  in a sealable package. The liquid  21  can comprise sterile water, saline, viscoelastic material and the like. 
       FIG. 17  illustrates a medical kit  300  that includes a preformed (wrapped, folded and/or rolled) donor disc  25   c  that may be releasably held in the holding member  10 . The medical product  300  can be held in a sterile package  90 . The package  90  can be a flexible package, such as an elastomeric- or foil-backed elastomeric package, or a rigid substrate package. Combinations of flexible and rigid packaging materials can also be used. 
     A fluid channel (conduit or other fluid channel configuration) can be provided as a separate tool in the kit  300  or may be provided as one of a standard component in a surgical suite. The fluid channel can be configured to engage a pressurized fluid flow source (such as a syringe, a cylinder, or other flow source) at a surgical site. 
     The kit  200 ,  300  and/or tool  10  can be labeled as single-use disposable. The tool  10  (at least the forward body thereof) can comprise a sufficiently strong and relatively rigid elastomer, composite or ceramic or may comprise a metal, such as stainless steel. Combinations of these types of materials may also be used. In other embodiments, the tool  10  can be resiliently configured with sufficient structural rigidity to hold and form the disc  25   c.    
       FIGS. 18A and 18B  illustrate that the combination harvesting tool and delivery device  10  may be configured with visual alignment indicia  31   i ,  31   o . The alignment indicia  31   i ,  310  can comprise arrows, text, color or marked regions on an external viewable surface of the respective devices. For example, arrows or other indicia  31   i ,  310  on a forward portion of the holder body can help an operator retract (arrow in,  31   i ) and implant (arrow out,  31   o ) a disc  25   r  in a desired orientation into the anterior chamber. This can facilitate reliable and proper positioning for enhanced operative positioning of the disc in the stromal bed. In other embodiments, no indicia is needed on the delivery device  10  as the configuration can be visibly unique (i.e., the holding member body may be configured so that the implantation orientation is visually different from a side or bottom portion) and the operator can align the indicia  31  with the target orientation of the delivery device, based on the configuration of the body. 
       FIGS. 19A and 19B  illustrate another embodiment of a tool  10 ′ that can cooperate with a flexible substrate  15  to form a donor disc  25  into a compact shape for implantation according to other embodiments of the present invention. As shown, two spaced apart prongs  12 ,  14  can hold the flexible substrate and tissue graft  25  and roll the tissue and substrate into a desired configuration. A collar  30  can be advanced to lock the tool holding the rolled or formed tissue  25  and flexible substrate  15 . 
       FIGS. 20A-20C  illustrate another embodiment of a tool  10  that can hold and/or deliver the tissue  25  to a patient. As shown in  FIG. 20A , the device  10  includes a carrier substrate  15  that is configured to hold the tissue graft  25 . The carrier substrate  15  can be a biocompatible, pre-shaped carrier. The tissue graft  25  can be drawn into the cannula  60 , which can be described as a delivery barrel. The forward end portion of the cannula  60  can include a tapered end  10   e  and can have a size (cross-sectional area and/or diameter) may allow for a self-sealing entrance wound, if desired. 
     As is also shown, the tool  10  includes a first cannula  60  (which can define at least a portion of a holding chamber) that is configured to slidably receive and hold the carrier substrate  15 , and a second cannula  65  that is attached to the first cannula  60  and that can be configured to slidably retract into the tool body  10   b . The tool  10  may also include a user slide control member  72  in communication with the carrier substrate  15  and, optionally, the cannula  65 . 
     As shown in  FIG. 20B , the substrate  15  with the target implantation tissue  25  can be slidably retracted into the cannula  60  and held for subsequent delivery to a patient in this configuration. A sterile covering  90  ( FIG. 22 ), such as a biocompatible, sterile pouch or bag, may be used to encase the loaded tool  10 . The device  10  can be retained in the retracted “hold” configuration and packaged in a sterile kit for longer term storage and shipment, or the device  10  can be loaded and used at a single clinical site, even as preparation for and/or during a patient surgery. 
       FIG. 20C  illustrates that, during actual implantation, once at a target implantation site, the second cannula  65  can be retracted substantially in concert with the substrate  15  to expose the tissue  25 . As the first cannula  60  is attached to the second cannula  65 , the first cannula  60  is also retracted, leaving the tissue  25  forward of the tissue delivery member  150  and out of the device  10 . This way a surgeon can orient the implant tissue  25  (e.g., donor cornea) while held in the tool  10  inside the eye in the cannula  60 , and when the cannula  65  is retracted the tissue  25  remains substantially in the desired position at the target implantation site. 
     The slide control member  72  can be configured to translate from an empty (ready to load) position ( FIG. 20A ), to a retracted “hold” position ( FIG. 20B ), then to a second retracted “delivery” position ( FIG. 20C ). The slide control member  72  can be moved from the first to the second position to slide the tissue  25  on the substrate  15  into the first cannula  60  while the first and second cannulas  60 ,  65  and tissue delivery member  150  remain substantially stationary. During a surgical procedure, the slide control member  72  can be axially slid further away from the patient, thereby retracting the first and second cannulas  60 ,  65  and the substrate  15  and exposing the tissue  25 . To inhibit inadvertent and/or premature release and/or exposure of the implant tissue  25  from the tool  10 , the slide control member  72  can cooperate with a locking member  73 . The locking member  73  can be configured to inhibit further retraction of the substrate  15  as well as retraction of the cannulas  60 ,  65  and/or substrate  15  until actual delivery is desired. 
     As shown in  FIG. 21 , the slide control member  72  can comprise a “thumb” or finger interface (e.g., a slide button or key) which is attached to the substrate  15  with a slide extension  72   e . The tool body  10   b  can be configured with a slot  73   s  that slidably receives and matably holds the lock member  73  in position. The lock member  73  can be attached to the cannula  65  with an axially extending slide extension  61 . To disengage the lock member  73 , a user can laterally move the lock member  73  out of the slot  73   s . The slide extension  72   e  can be biased to axially translate to allow a mating segment  72   m  (such as a tab or protrusion) of the slide extension  72   e  to engage the slide extension  61  (such as via a mating slot or key form). The locking engagement of the slide extensions  72   e ,  61  can maintain a desired alignment of the cannula(s) with the substrate and donor tissue  25 . In operation, after the lock member  73  is disengaged, as the slide control member  72  retracts, the substrate  15  and the cannulas  60 ,  65 , retract substantially in concert therewith. 
     In other embodiments, two separate slide controls may be used to retract the cannulas  60 ,  65  and substrate  15  separately, either independently or dependently (not shown). Similarly, the lock member  73  can be configured in other ways to inhibit premature sliding, such as, but not limited to, having a removable external locking ring that engages a stationary tab (not shown). 
     It is also noted that, instead of two cannulas  60 ,  65  as shown, for example, in the embodiment in  FIGS. 20A-20C , a single sliding cannula may be used (not shown). If so, the single cannula may be stepped in diameter size (typically more narrow toward the penetration tip end). In any event, in some embodiments, at least the forward portion of the first cannula  60  can be visually transmissive to allow a user to confirm the position of the donor tissue and/or carrier substrate  15 . 
     As shown in  FIG. 20B , the tool  10  can also include a fluid delivery member  150  held with an end portion residing inside the first cannula  60  in communication (upstream but proximate to) with the implant material  25 . The tool  10  can be configured to provide flow-through irrigation via the delivery member  150  that may be used to deploy tissue allograft and/or maintain chamber depth. In operation, the member  150  can be configured to remain substantially stationary both during initial loading of this carrier with tissue  25  into the cannula  60 , and while the second cannula  65  and the first cannula  60  are axially retracted. The member  150  may be configured to facilitate the ejection of the tissue  25  from the tool  10 . The member  150  may be configured to deliver pressurized fluid from the syringe  95  (FIG.  22 ). The member  150  can contact the tissue  25  directly and/or flowably direct fluid to contact the tissue  25 . The member  150  can also deliver or push an intermediate fluid such as a gel (comprising, for example, a viscoelastic material) against a trailing edge of the tissue  25  to eject the tissue from the cannula  60  into a patient. 
     As shown in  FIGS. 20A-20C , a proximal end portion of the device  10   p  may also comprise a luer lock  74  configured to releasably and sealably engage a syringe with sterile fluid (shown as feature  95  in  FIG. 22 ). Sterile biocompatible fluid from the syringe  95  can be directed to flow through the device and exit the distal end portion of the device  10   d . As noted above, the fluid can be used to deploy the target tissue, maintain chamber depth, and/or introduce supplemental target material to facilitate implantation, preparation and/or healing. The sterile biocompatible fluid may comprise gas and/or liquid. The syringe  95  can be used to flush the implant site prior to release of the target tissue delivery, and the fluid for this purpose typically comprises saline. The syringe  95  may also optionally be used to “prime” the fluid channel (s) extending in the tool  10  to employ the sterile fluid to eject air from the fluid irrigation channel(s) prior to surgical penetration in the target body region. The tool  10  can be configured to accept different fluids from different or the same syringe before or during the procedure. The syringe  95  can be configured to hold and deliver through the tool  10  a therapeutic fluid treatment. The luer lock  74  can be sealed closed prior to use to inhibit contamination (not shown). Similarly, a cap can be placed over the forward end of the tool  10   e  (also not shown). 
     In some particular embodiments, the tool  10  can provide a surgeon with substantially atraumatic donor corneal tissue handling and may promote precision placement of donor corneal allograft in a recipient&#39;s anterior chamber. The donor tissue can also be substantially atraumatically unsheathed in the recipient eye. As discussed above, the tool  10  can be single-use disposable. 
       FIG. 22  illustrates another embodiment of a medical kit  400 . This medical kit  400  can comprise the tool  10  (loaded or unloaded with the donor tissue  25 ) and a biocompatible sterile 95 syringe. The syringe  95  can be configured with a male luer lock  96  sized and configured to matably engage with the female luer lock  74  on the tool  10 . Each component may be held in sterile packaging  90 . 
       FIG. 23  illustrates a data processing system that may be used to control fluid delivery and/or plunger operation in some automated or semi-automated delivery systems. Thus, as will be appreciated by one of skill in the art, embodiments of the invention may be embodied as a method, system, data processing system, or computer program product. Accordingly, particular embodiments of the present invention may take the form of an entirely software embodiment or an embodiment combining software and hardware aspects, all generally referred to herein as a “circuit” or “module.” Furthermore, certain particular embodiments of the present invention may take the form of a computer program product on a computer-usable storage medium having computer-usable program code embodied in the medium. Any suitable computer-readable medium may be utilized including hard disks, CD-ROMs, optical storage devices, a transmission media such as those supporting the Internet or an intranet, or magnetic or other electronic storage devices. 
     As such, computer program code for carrying out operations of the present invention may be written in an object oriented programming language such as Java, Smalltalk or C++. However, the computer program code for carrying out operations of the present invention may also be written in conventional procedural programming languages, such as the “C” programming language or in a visually oriented programming environment, such as VisualBasic. 
     Certain of the program code may execute entirely on one or more of the user&#39;s computer, partly on the user&#39;s computer, as a stand-alone software package, partly on the user&#39;s computer and partly on a remote computer or entirely on the remote computer. In the latter scenario, the remote computer may be connected to the user&#39;s computer through a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, some program code may execute on local computers and some program code may execute on one or more local and/or remote server. The communication can be done in real time or near real time or off-line using a volume data set provided from the imaging modality. 
     The invention is described in part herein with reference to flowchart illustrations and/or block diagrams of methods, systems, computer program products and data and/or system architecture structures according to embodiments of the invention. It will be understood that some blocks of the illustrations, and/or combinations of blocks, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general-purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the block or blocks. 
     These computer program instructions may also be stored in a computer-readable memory or storage that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory or storage produce an article of manufacture including instruction means which implement the function/act specified in the block or blocks. 
     The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions/acts specified in the block or blocks. 
     As illustrated in  FIG. 23 , embodiments of the invention may be configured as a data processing system  116 , which can be used to facilitate or carry out delivery of the disc  25 , and can include a processor circuit  100 , a memory  136  and input/output circuits  146 . The data processing system may be incorporated in, for example, the tool  10  alone and/or one or more of a personal computer, workstation, server, router or the like. The processor  100  communicates with the memory  136  via an address/data bus  148  and communicates with the input/output circuits  146  via an address/data bus  149 . The input/output circuits  146  can be used to transfer information between the memory (memory and/or storage media)  136  and another computer system or a network using, for example, an Internet protocol (IP) connection. These components may be conventional components such as those used in many conventional data processing systems, which may be configured to operate as described herein. 
     In particular, the processor  100  can be commercially available or custom microprocessor, microcontroller, digital signal processor or the like. The memory  136  may include any memory devices and/or storage media containing the software and data used to implement the functionality circuits or modules used in accordance with embodiments of the present invention. The memory  136  can include, but is not limited to, the following types of devices: ROM, PROM, EPROM, EEPROM, flash memory, SRAM, DRAM and magnetic disk. In some embodiments of the present invention, the memory  136  may be a content addressable memory (CAM). 
     As further illustrated in  FIG. 23 , the memory (and/or storage media)  136  may include several categories of software and data used in the data processing system: an operating system  152 ; application programs  154 ; input/output device drivers  158 ; and data  156 . As will be appreciated by those of skill in the art, the operating system  152  may be any operating system suitable for use with a data processing system, such as IBM®, OS/2®, AIX® or zOS® operating systems or Microsoft® Windows®95, Windows98, Windows2000 or WindowsXP operating systems Unix or Linux™. IBM, OS/2, AIX and zOS are trademarks of International Business Machines Corporation in the United States, other countries, or both while Linux is a trademark of Linus Torvalds in the United States, other countries, or both. Microsoft and Windows are trademarks of Microsoft Corporation in the United States, other countries, or both. The input/output device drivers  158  typically include software routines accessed through the operating system  152  by the application programs  154  to communicate with devices such as the input/output circuits  146  and certain memory  136  components. The application programs  154  are illustrative of the programs that implement the various features of the circuits and modules according to some embodiments of the present invention. Finally, the data  156  represents the static and dynamic data used by the application programs  154  the operating system  152  the input/output device drivers  158  and other software programs that may reside in the memory  136 . 
     The data  156  may include (electronically stored) predefined flow mode data sets  126 , such as a pre-delivery flow and an active delivery flow of one or more flow pressures and/or flow rates. As further illustrated in  FIG. 23 , according to some embodiments of the present invention application programs  154  include a Flow Control or Fluid Regulator Module  120 . The application program  120  may be located in a local server (or processor) and/or database or a remote server (or processor) and/or database, or combinations of local and remote databases and/or servers. 
     While the present invention is illustrated with reference to the application programs  154 ,  120  in  FIG. 23 , as will be appreciated by those of skill in the art, other configurations fall within the scope of the present invention. For example, rather than being application programs  120 ,  154  these circuits and modules may also be incorporated into the operating system  152  or other such logical division of the data processing system. Furthermore, while the application program  120  is illustrated in a single data processing system, as will be appreciated by those of skill in the art, such functionality may be distributed across one or more data processing systems. Thus, the present invention should not be construed as limited to the configurations illustrated in  FIG. 23 , but may be provided by other arrangements and/or divisions of functions between data processing systems. For example, although  FIG. 23  is illustrated as having various circuits and modules, one or more of these circuits or modules may be combined or separated without departing from the scope of the present invention. 
     As shown in  FIG. 24A , as discussed with respect to  FIGS. 19A and 19B , the medical tool  10  can have first and second cooperating elongate members  12 ,  14 . The elongate members  12 ,  14  may have a length that is between about 6-15 mm, typically about 8-10 mm. As shown, the tool  10  receives a side edge portion of the disc  25  as shown in  FIG. 24A . As shown in  FIG. 24B , the distal edges of the members  12 ,  14  can be spaced apart by a distance  16  during the initial positioning. The distance  16  can be greater than the thickness of the donor disc  25 . To provide for adequate separation and disc thickness variation, the distance  16  may be at least about 300 μm, typically between about 300-600 μm thick. However, other separation distances in the open configuration shown in  FIGS. 24A and 24B  may also be used. In this embodiment, the tool  10  can be described as a rolling tool  10  that rolls the disc  25  so that the lower donor stromal surface is on the outside surface  25   e  of the rolled body  25   r  ( FIG. 28 ). In the embodiment shown in  FIGS. 24A, 24B , no flexible substrate carrier is required. Also, the donor disc  25  can be rolled from a top edge portion toward a bottom edge portion. However, other rolled orientations can also be used (and the upper donor stroma may be on the outside of the rolled body). 
     As shown in  FIGS. 25A and 25B , the elongate members  12 ,  14  also have a closed configuration whereby the members  12 ,  14  close to clamp or trap a side edge portion of the donor disc therebetween. In operation, a sleeve  30  can axially slide forward to force the members  12 ,  14  together. Typically, the members  12 ,  14  gently contact when in the closed configuration without the disc  25  therebetween as shown in  FIG. 25B .  FIGS. 26 and 27  illustrate that after the sleeve  30  is moved forward to close the members  12 ,  14  together with the side edge portion of the disc  25  therebetween, the tool  10  can be rotated one or more times to form the disc  25  into a rolled compact configuration as shown in  FIG. 28 . In this exemplary configuration, the disc  25  can have a rolled body  25   r  that has a length that is between about 8-8.25 mm and a width W (or height) of less than about 3 mm, typically about 2.5 mm. 
     During the rolling, the members  12 ,  14  are spaced apart and gently contact the disc  25  in a manner that allows the members  12 ,  14  to hold the disc  25  during rolling without imparting undue force on the endothelial cells to inhibit cellular injury. 
     Other tool configurations may be used to roll the disc into the desired configuration. For example, in some embodiments, an end cap or end clamp (not shown) can be used to force the members  12 ,  14  together (not shown). Similarly, the distal end of the tool may have a closed end rather than an end that can open and close, and the disk  25  can be inserted in between the two members  12 ,  14  (also not shown). It is also contemplated that a different roller tool configuration can be used, such as a single member (rather than cooperating spaced apart members) that can roll the disc (not shown). For example, a single member may cooperate with a separate tool or even manual manipulation until a first roll is started, and/or the tool may even employ a gentle biocompatible (liquid) adhesive. 
     Although the tool  10  is particularly suitable for rolling the disc  25 , the tool  10  can be used to fold or otherwise hold the disc  25  as well. That is, it is contemplated that the tool  10  can fold the body of the disc with a lesser likelihood of endothelial damage compared to forceps where the force applied is less controlled. Indeed, the tool  10  may be used to hold the disc  25  in larger configurations for larger incision placement. 
     The elongate members  12 ,  14  can have a rounded cross-sectional shape and may have a smooth resilient contact surface, and may have a resilient body with sufficient rigidity to hold the disc during the rolling operations. The elongate members  12 ,  14  may comprise, for example, foam, sponge, cellulose, elastomer or polymer. The elongate members  12 ,  14  may also be formed of metal. The members  12 ,  14  may include surface coatings that inhibit slipping or provide lubricity to inhibit contact damage. 
     To promote reliability, efficiency and/or ease in surgical placement, it is contemplated that a standard rolled orientation will be used and/or that different medical kits noting the surgeon&#39;s desired rolled orientation can be provided. The latter can allow a surgeon to order a kit that is suitable for the particular entry incision used (which may vary depending on patient eye structure) and/or for a desired unrolling technique (side to side, top to bottom, bottom to top, offset, and the like). The rolled disc  25   r  may be configured for a temporal side or a superior entry. 
     When unrolling in situ, rather than placing the rolled disc medially in the recipient stromal bed, the rolled disc  25   r  ( FIG. 5 ) may be inserted closer to a side edge portion of the eye, the side edge portion typically being the one that corresponds to the last rolled portion. The donor disc can then be unrolled in an opposite direction using physical or fluid forces. 
     To promote increased efficiency in surgical procedures, an OEM or medical company can provide the donor disc  25  preformed in the rolled configuration  25   r  ( FIG. 28 ) and ready for surgery. The rolled disc  25   r  may be held in a refrigerated storage condition prior to end use. The disc  25  may be rolled using different end use disc sizes and provided in a pre-formed rolled configuration for different end use sizes (about 8 mm and about 8.25 mm). 
       FIG. 29  illustrates that, in some embodiments, the rolling tool  10  can insert the rolled disc  25   r  into a discrete delivery device  250 . In other embodiments, the tool  10  can hold the rolled disc  25   r  during implantation and hence, be the delivery device. As shown in  FIG. 29 , the delivery device  250  has a holding chamber  51  with a forward open portion  52 ; the forward portion  52  may have a beveled shape as shown. The chamber  51  is in fluid communication with a fluid source  75  ( FIG. 31 ). The device  250  may also include a plunger  60 . 
     In some embodiments, after the tool  10  enters the chamber  51 , the sleeve  30  is retracted, thereby depositing the disc in the chamber  51 . The tool  10  can be removed from the device  250 . The tool  10  can be sterilized for re-use or be single-use disposable. As shown in  FIG. 30 , the rolled disc  25   r  is held in the chamber  51 . The chamber  51  can have a width We that is between about 2.75 mm to about 5 mm, typically between about 3-4 mm wide, and in some embodiments about 3 mm wide. The chamber  51  has a length L sufficient to hold the length of the disc  25  therein, and is typically between about 8.5-10 mm long, typically about 9 mm long. Pressurized fluid can be introduced into the chamber  51  to urge or force the rolled disc  25   r  to exit the chamber  51 . In some embodiments, as shown in  FIG. 31 , a perforated plunger  60  can be advanced to help expel the disc  25  from the chamber  51 . The plunger  60  can allow fluid to enter the chamber through perforations or openings  66  in the plunger body. The fluid can comprise air, oxygen, saline, water or other suitable fluid. The openings  66  can be on the plunger head and/or via the arm  62 . A different fluid can be introduced via the channel or opening in the arm  62 . For example, air can be introduced through the arm  62  while a liquid can be introduced via side openings  66 . Where a lubricant and/or viscoelastic substance (such as HEALON from Pharmacia in Nutley, N.J.) is used to preserve or protect the rolled disc  25   r , a pre-delivery flushing may be desired to prepare the rolled disc  25   r  for surgical insertion (to remove at least some of the substance from the rolled disc  25   r  or chamber  51  prior to placement in the body). 
     The plunger  60  can be configured to allow a surgeon to manually advance the plunger  60  using the plunger arm  62 , and the fluid source  75  may be directed to flow to the chamber  51  from a channel  53  that merges into the channel  63  in which the plunger arm  62  travels.  FIG. 32A  illustrates the device  250  with two paths  53 ,  63  and  FIG. 32B  illustrates the open end  52  of the device  250 . This open end  52  may be capped or sealed prior to use to help seal the disc in a sterile environment. 
     In other embodiments, the plunger  60  can be configured to advance based on the pressurized fluid  75  and no separate plunger arm or plunger arm channel is required (not shown). In such a case, the channel  53  can be a straight channel (such as the plunger arm channel  63 ) to inhibit pressure drops. In any event, where a plunger  60  is employed, the plunger  60  may be configured to push indirectly, such as by pushing an intermediate fluid such as a gel (comprising, for example, a viscoelastic material) forward, thereby pushing the disc forward, or may directly (gently) contact the trailing edge of the rolled disc  25   r.    
       FIG. 33  illustrates an exemplary surgical introduction of the device  250  to insert the rolled disc  25   r  into position in a recipient. As shown, fluid can be introduced into the chamber  51  and directed to flowably expel the rolled disc into position. The plunger  60  can be advanced to help expel the disc  25   r  as needed.  FIG. 36  illustrates that the delivery device  250 ′ can include a plurality of spaced apart flow orifices  54  (and may include micronozzles) that are configured to introduce fluid from a wall of the device into the chamber  51 . The orifices  54  have an associated fluid channel  55  that can merge into the primary channel  63 . The orifices  54  can reside axially and circumferentially spaced apart about the chamber  51  or may reside substantially aligned in a rearward portion of the chamber  51  to help initiate the expellant flow force onto the disc  25   r . The orifices  54  may be configured as flushing ports that can expel pressurized fluid generally inward and axially forward. Alternatively, the orifices  54  can be configured to emit fluid under lesser pressures to inhibit adhesion to the chamber walls. 
       FIGS. 34-37  illustrate examples of preformed donor discs  25  provided as a medical product or kit  90 . The reference number  90  is used to generally denote the medical product, but with respect to each embodiment in  FIGS. 34-37 , an alphabetical suffix is used to differentiate the specific product embodiment therein (i.e.,  90   a ,  90   b ,  90   c ,  90   d ). The medical product  90  can be held in a sterile package  91 . The package  90  can be a flexible package, such as an elastomeric- or foil-backed elastomeric package, or a rigid substrate package. Combinations of flexible and rigid packaging materials can also be used. A quantity of biocompatible liquid  92  can be placed about the disc  25  in the package  91 . The liquid  92  can comprise sterile water, saline, viscoelastic material and the like. 
       FIG. 34  illustrates that the product  90   a  comprises a holding device (shown as the rolling tool itself) and the rolled disc  25   r .  FIG. 35  illustrates that the product  90   b  can be the rolled disc alone in the package  91 .  FIG. 36  illustrates that the product  90   c  can be a delivery tool  250  with the rolled disc  25   r  already in position therein. A fluid channel (conduit or other fluid channel configuration) can be provided as a separate tool in a kit or may be provided as standard components in a surgical suite.  FIG. 37  illustrates the delivery device  250  and rolled disc  25   r  as well as a length of rigid flow pipe and/or flexible flow channel  53  that is configured to engage a pressurized fluid flow source (such as a syringe, a cylinder, or other flow source) at a surgical site. 
     In the product  90 , the delivery device  250  and/or tool  10  can be labeled as single-use disposable. The portions of the product  90  that contact the body should be made from a biocompatible material and/or comprise a biocompatible coating. 
     The tool  10  and/or delivery device  250  (at least the forward body thereof) can comprise a sufficiently strong and relatively rigid elastomer, composite or ceramic or may comprise a metal, such as stainless steel. Combinations of these types of materials may also be used. In other embodiments, the tool members  12 ,  14  can be resiliently configured with sufficient structural rigidity to hold and form the rolled disc  25   r.    
       FIG. 38  illustrates that the delivery device  250 ″ may be resiliently compressible as represented by the arrows on each side of the device body. In operation, the outer wall  250   w  forming the chamber  51  can be compressed or pushed together to urge the disc  25   r  out of the chamber  51 . In operation, a clinician can compress a rearward portion of the chamber  51  and work his or her way forward to squeeze or urge the disc out of the chamber. The device  250 ″ may be configured to expel the disc  25   r  out and into position in the eye using only the compressibility of the walls, or the device  250 ″ may be optionally configured to also employ a plunger and/or pressurized fluid as for the embodiments noted above. The device chamber  51  can be defined by a plasticized polymer or other suitable elastomeric material. 
       FIG. 39  illustrates that the rolling tool  10  or the delivery device  250 ′″ (which can be used with any delivery device, such as embodiments  250 ,  250 ′,  250 ″) may be configured with visual alignment indicia  31 ,  151 . The alignment indicia  31 ,  151  can comprise arrows, color or marked regions on an external viewable surface of the respective devices. For example, arrows or other indicia  31  on the sleeve  30  or forward portion of the body, such as a forward visible portion of members  12 ,  14 , can help an operator insert the rolled disc  25   r  in a desired orientation into the chamber  51 . This can facilitate reliable and proper positioning for enhanced operative positioning of the disc in the stromal bed. Similarly, visual indicia marking  151  on the delivery device  50 ′″ can facilitate proper orientation with the incision cite and/or alignment with the tool  10  and/or  250 . In other embodiments, no indicia is needed on the delivery device  250  as the configuration can be visibly unique (i.e., the top is visually different from a side or bottom portion) and the operator can align the indicia  31  with the target orientation of the delivery device, based on the configuration of the body. 
     The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.