US20050113844A1 - System for packaging and handling an implant and method of use - Google Patents

Abstract

A system designed to store an implant together with the tools necessary to implant the stored implant, and a method of using said system. Such system includes an implant storage tool adapted to retain the implant within a storage container. The implant storage tool is operable to provide an implant applicator.

Description

• This application is a Continuation of application Ser. No. 10/290,721, filed on Nov. 8, 2002, which is a division of application Ser. No. 09/660,371 filed on Sep. 12, 2000, now U.S. Pat. No. 6,543,610.
FIELD OF THE INVENTION
• The present invention relates to a system for packaging, handling and applying implants. Additionally, this invention relates to a method for introducing a corneal implant to the corneal surface.
BACKGROUND OF THE INVENTION
• Current methods and devices used to store small, delicate, and normally transparent implants entail free-floating the implant in a volume of storage fluid contained within a storage bottle or other container. This manner of storage is oftentimes used to preserve retinal transplants, brain tissue transplants, corneal implants, tissue biopsies and any other delicate biological specimen. Free-floating storage, however, subjects a stored specimen or implant to fluid agitation, which can severely and irreparably damage the integrity of the stored material. In addition, isolating transparent specimens from the storage fluid is difficult to achieve.
• Corneal implants are especially susceptible to the above described problem. Corneal implants are used to correct visual disorders such as Myopia or near-sightedness, Hyperopia or far-sightedness, Presbyopia or difficulty in accommodating a change in focus, and Astigmatism. To correct these disorders, the implant is introduced into the body of the cornea in known ways, such as after a flap is formed and an under surface of the cornea is exposed. The implant, changes the shape of the cornea and alters its refractive power. These implants are generally made of various types of hydrogels, but can include other polymers, tissue implants, or the like. In the past, storing the corneal implant required free-floating the implant in a volume of storage fluid contained within a storage container. To retrieve the implant, one had to first locate the implant within the fluid, and then remove the implant using a filter device or sequestering tool. In the case of a corneal implant, locating the implant is complicated by both the size and transparency of the implant. For instance, a corneal implant generally has a diameter of about 4.0 to 7.0 mm and a center that is normally fabricated having a thickness ranging from 25 to 50 microns. Due this minuscule size, physically grasping the implant from the storage fluid using tweezers, or the like, is simply not practical.
• Successful isolation of a corneal implant, or other specimen, generally requires the use of a sieve to separate the implant from the fluid. Isolating the implant in this manner, however, subjects the implant to mechanical forces, which could lead to a loss of the implant. If not damaged, the transparent implant must still be located on the sieve surface and retrieved. The implant must therefore be grasped using tweezers, forceps, or the like. Imparting such force upon the implant, however, can also damage the implant. Using force imparting tools to hold the implant is therefore not desirable. Current isolation techniques are therefore difficult, time-consuming and create additional steps, which can also lead to implant contamination. Thus, it is desired to have an implant storage and handling system, which allows the user to rapidly and successfully retrieve the implant for prompt implantation.
• Current devices used to deposit an implant onto the cornea surface generally deposit the corneal implant onto the cornea surface in a bunched or folded conformation. Aligning the implant in planar relation to the cornea surface requires the surgeon to manipulate or tease the implant so as to remove any folds or bends in the implant. Problematically, the step of unfolding the implant on the cornea surface can cause serious trauma to the cornea surface. This trauma can lead to the formation of edema, or other deleterious responses that lead to rejection or displacement of the implant.
• Thus, there is believed to be a demonstrated need for a unitary packaging and handling system that provides the desired storage capabilities, easy retrieval of the specimen from that storage, and tools that are operable to retrieve and utilize the specimen without causing damage to the specimen or an implantation site. There is also an additional need for a more effective method for implanting a corneal implant onto a cornea surface.
SUMMARY OF THE INVENTION
• The present invention relates to an implant packaging and handling system which includes a storage bottle having an opening to receive a volume of implant storage fluid, and an implant holding tool designed to retain the implant in fluid communication with the implant storage fluid. A storage bottle stopper holds the implant holding tool, so that a portion of the implant holding tool is immersed within the storage fluid upon placement of the stopper into the bottle, placing the implant in fluid communication with the storage fluid. The implant holding tool includes a retaining member detachably mounted to an implant applicator tool. Together they define an enclosure for retaining the implant in a secure, known storage position.
• The implant applicator tool has an arcuate-shaped applicator surface with a plurality of openings. The arcuate shaped surface is contoured to correspond to the curvature of the cornea surface, which aids in the proper implantation of the implant to the cornea surface. In one embodiment, the applicator surface has one or more recessed surfaces designed to hold and center the implant on the applicator surface. One or more recessed grooves are also provided to allow fluid to flow between the implant and the applicator surface.
• The openings have numerous advantages. The openings provide continuous fluid communication between a retained implant and the implant storage fluid. Upon removal from storage, the openings enable the user to unfold and orient the implant by gently passing fluid through the openings so as to float the implant into a desired central position on the applicator tool surface. Once so positioned, the user is then able to aspirate the fluid/from between the implant and the applicator tool, thereby resting the implant firmly against the applicator tool surface. The applicator tool also includes a central opening providing the user with a reference point for centering the applicator surface, and thus, the implant onto the surface of the cornea.
• The present invention also relates to a method of implanting a corneal implant using the implant packaging and handling system. The initial step includes surgically preparing the cornea surface for implantation. Next, the implant and implant holding tool are retrieved from the storage bottle, and the retaining member removed so as to provide an applicator tool together with implant. The applicator can then be attached to a handle for ease of use. The implant is then properly aligned on the applicator tool and deposited onto the surgically prepared cornea surface. Finally, the cornea is restored.
BRIEF DESCRIPTION OF THE DRAWINGS
• A better understanding of the invention can be obtained from the detailed description of exemplary embodiments set forth below, when considered in conjunction with the appended drawings, in which:
• FIG. 1 is a partial sectional view of the implant packaging and handling system of the present invention;
• FIG. 2 is a schematic representation of the implant applicator tool fastened to a retaining member, providing the implant storage tool of the present invention;
• FIG. 3 is a schematic representation of the implant applicator tool of the present invention;
• FIG. 4 is a schematic representation of the retaining member adapted to form an implant retaining enclosure when fastened to the implant applicator tool ofFIG. 3;
• FIG. 5 is a bottom view of a stopper used to seal the storage bottle of the present invention, showing the implant storage tool engagement slot in an open position;
• FIG. 6 is a cross-sectional view through the stopper ofFIG. 5 taken on line10-10;
• FIG. 7 is a partial sectional view of the bottle stopper positioned within the storage bottle, showing the implant storage tool engagement slot in a closed position;
• FIG. 8 is a cross-section at view through the stopper and storage bottle ofFIG. 7 taken on line20-20;
• FIG. 9 is a schematic illustration of the implant applicator tool secured to a handle;
• FIG. 10 is a side view of the implant applicator tool secured to a handle, showing the curved surface of the implant applicator tool, which corresponds with the contour of the cornea surface;
• FIG. 11 is a schematic representation of an implant applicator tool having a central opening for aligning the applicator tool with the visual or pupillary axis of the eye;
• FIG. 12 is a schematic representation of an implant applicator tool having a recessed surface defining a central opening and adjacent alignment slot;
• FIG. 13 is a schematic representation of a retaining member adapted to engage with the applicator tools shown inFIGS. 9 and 12;
• FIGS. 14a,14b,14c,14dand14eare cross-sectional views of a human eye illustrating the method of introducing an implant to the cornea surface using the implant applicator tool of the present invention.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
• FIGS. 1 through 14eof the drawings show an implant packaging andhandling system10 of the present invention. As illustrated inFIG. 1, thepreferred system10 includes acylindrical storage bottle11 for holding implant storage fluid (not indicated). Thebottle11 is sealed by a stopper12 having anupper cap portion14 and aplug portion13, which is adapted to detachably couple to animplant storage tool15. A protective safety seal17 provides tamper resistance and maintains the stopper12 in sealed relation to thebottle11.
• FIGS. 2 through 4 show a retainingmember16 andimplant applicator tool19, which together define theimplant storage tool15. As illustrated, the retainingmember16 is adapted to detachably engage theimplant applicator tool19, thereby defining anenclosure41 operable to retain the implant. Both the retainingmember16 and theapplicator tool19 include a plurality ofopenings18 and22, respectively, which allow storage fluid to communicate into theimplant retaining enclosure41. As shown inFIG. 1, theimplant retaining enclosure41 is located on the end ofstorage tool15 that is distal to the stopper12 such that theenclosure41 is immersed in implant storage fluid when thestorage tool15 is inserted into thebottle11. When the implant is stored, theenclosure41 ofstorage tool15 holds the implant in the storage fluid, while also providing a user with ready access to the implant. The user simply removes the stopper12, thereby removing thestorage tool15 from thebottle11, and detaches the retainingmember16 from theapplicator19 to access the implant.
• As illustrated inFIG. 3,applicator tool19 has ahandle attachment arm20 connected through abody portion21 to animplant applicator member45. Thebody portion21 is preferably shaped to provide a broad handling surface. For instance,FIGS. 2 and 3 show abody portion21 having a broad elliptical shape, which allows a user to more easily manipulate theapplicator tool19. As shown, theimplant applicator member45 includes anapplicator surface42 having a plurality ofopenings22 to provide fluid communication between theapplicator surface42 and an implant resting thereon.Openings22 further allow the user to release the implant from theapplicator surface42. More particularly, the user can impart force upon the implant by passing through theopening22 either a flow of fluid or a cantilever so as to forcibly separate the implant from the applicator member surface42 (as is shown inFIG. 14).
• In a preferred embodiment, theapplicator surface42 has acentral opening23 to help the user align theapplicator surface42 along the visual or optical axis of the eye. As shown, the centrally positionedopening23 defines a circular opening having a diameter greater than the diameter of the surroundingopenings22. In this way, the user is provided with a central point of reference, which enables the user to align theapplicator surface42 with the optical axis of the eye, and thus, properly position the implant.
• In another embodiment, theapplicator tool19 may include anapplicator alignment notch24 positioned integral to thesurface42 of theapplicator member45. For instance,FIGS. 3 and 12 show thenotch24 extending inwardly towards the centrally positionedalignment opening23. In this embodiment, thenotch24 is used to align the implant on thecornea surface39, as well as release the implant from theapplicator surface42. Specifically, thenotch24 is dimensioned to allow a cantilever, or like instrument, to pass through the notch, thereby allowing the user to impart force against an implant held on theapplicator surface42. Specifically, the user lifts theapplication tool19 away from the cornea surface while simultaneously imparting downward force on the implant through thenotch24 so as to release the implant. One skilled in the art will understand that various notch positionings can be incorporated into theapplicator member45 without departing from the scope of the present invention.
• As shown inFIG. 2, the retainingmember16 has anouter surface44 defining a plurality ofopenings18 that provide fluid communication to an implant retained by theenclosure41.FIG. 4 shows a retainingmember16 disengaged from theapplicator tool19 shown inFIG. 3. To secure the retainingmember16 to theapplicator tool19, the retainingmember16 is provided withattachment tabs26a-cadapted to insert intocorresponding attachment slots25a-cintegral to theapplicator tool19. In use, the retainingmember16 is attached to theapplicator tool19 by simply inserting thetabs26a-cinto the respectivecorresponding slots25a-c, and then positioning the bottom surfaces28 of retainingmember side walls43 against theapplicator surface42. In a preferred embodiment, at least oneside wall43 has an overlappingflexible portion27 adapted to bend about the distal edge of theapplicator surface42, thereby securely clamping the retainingmember16 to theapplicator tool19. To remove the retainingmember16, the user merely unclamps theflexible portion27 by bending it away from theapplicator tool19, and lifting themember16 so as to disengagetabs26a-cfromslots25a-c.
• As illustrated inFIGS. 9, 11,12 and13, analternative attachment tab26 andattachment slot25 can also be used with the present invention. For instance,FIG. 12 shows anapplicator tool19 having fourseparate attachment slots25, while in comparisonFIG. 3 shows anapplicator tool19 having threeseparate attachment slots25a-c. It will be understood by those skilled in the art that various embodiments forattachment slots25 andtabs26 can be incorporated into theapplicator tool19 and retainingmember16 without deviating from the scope of the present invention.
• As illustrated inFIGS. 5 through 8, a preferred embodiment ofsystem10 includes a bottle stopper12 adapted to receive and securely hold thehandle attachment arm20 of theapplicator tool19. The stopper12 preferably includes anupper cap portion14 and aplug portion13 dimensioned to insertably seal thebottle11.FIG. 5 shows thestopper plug portion13, which is not inserted into a storage bottle opening46 (shown inFIG. 8). In comparison toFIG. 5,FIG. 7 shows theplug13 inserted into thestorage bottle opening46. As illustrated byFIGS. 5 and 7, plugportion13, when removed frombottle opening46, adopts an elliptical shape by distending in an outwardly direction along line the10-10. Likewise, inserting stopper12 into bottle opening46 causes the outer diameter ofplug portion13 to conform to the inner diameter of theinner bottle surface34. In this way, theplug portion13 becomes inwardly compressed along line30-30. Referring toFIGS. 6 and 8, cross-section views are shown ofstopper plug portion13 in an out-of-bottle elliptical shape and an in-bottle compressed circular shape, respectively. The utility of this embodiment is described in more detail below.
• Anengagement slot32 is located integral to plugportion13 in an orientation perpendicular to line10-10. As illustrated inFIGS. 5 through 8, theengagement slot32 opens or closes in response to either the removal or insertion of theplug portion13 from thebottle opening46, respectively. Referring toFIGS. 5 and 6, theengagement slot32 is shown in an open position. More particularly, when the user removes the stopper12 frombottle opening46, theplug portion13 adopts an unrestrained elliptical shape by distending outwardly along the line10-10 for openingslot32. In this way, theengagement arm20 of theapplicator tool19, which is held by the engagement theslot32, is easily separated fromslot32 once the stopper12 is removed from thestorage bottle11. By way of comparison,FIGS. 7 and 8 show theengagement slot32 adopting a closed conformation upon insertion of the stopper12 into thebottle opening46. As shown inFIG. 7, insertion of the stopper12 into thebottle11 causes theouter surface47 of theplug portion13 to conform to the inner diameter of thebottle opening surface34, which imparts force in the direction of the line30-30. In this way, theslot32 is forced into a tight, closed conformation. Thus, theengagement arm20 of theapplicator tool19 is held by aslot32 in a secure position when the stopper12 is inserted into thebottle11. The stopper12 is preferably made of silicone rubber, or other elastomeric material.
• FIGS. 9 and 10 show anapplicator tool19 attached to ahandle30. The applicatortool attachment arm20 detachably mounts to thehandle30 through ahandle fastener31. It will be understood by those skilled in the art that numerous types of handles and handle fasteners are available that can be used with theapplicator tool19 without departing from the scope of the present invention.
• As illustrated byFIG. 10, theimplant applicator member45 has acurved applicator surface42, which corresponds to the curvature of the cornea implant site. This curved surface allows the user to position thecurved applicator surface42 evenly across the cornea surface, enabling the implant to be more evenly deposited onto the cornea surface. Referring toFIGS. 9 and 12, eachapplicator member45 is shown having a recessedapplicator surface29. As shown, the recessedsurface29 is preferably circular, thereby allowing a substantially circular implant to be centrally positioned on theapplicator member45. In addition, thecentral opening23 which is centered relative to the perimeter of thecircular recess29, provides the user with a reference point for alignment of theapplicator member45 with the pupil diameter. In this way, the implant can be properly aligned on the cornea surface.
• FIG. 11 shows anapplicator tool19 having anapplicator surface42 with recessedgrooves29 to allow fluid to flow between theapplicator surface42 and an implant supported on thesurface42. It should be understood by one skilled in the art that alternatively dimensioned recesses and grooves can be formed in theapplicator surface42 without departing from the scope of the present invention. It is advantageous to provide fluid flow between thesurface42 and the implant to enable the user to more easily manipulate the implant while it is on theapplicator surface42. During storage, for example, the implant may come to rest in various folded and bunched conformations. Once the retainingmember16 is removed, the user can manipulate the implant into its desired conformation by gently passing a volume of fluid through theopenings22 and23. More particularly, the implant will overlap a small volume of fluid, thereby allowing the user to floatingly realign the implant on theapplicator surface42. After the implant is aligned, the fluid can be removed by simply touching the underside of theapplicator member45 with a cotton swab, or like absorbent material.
• FIGS. 12 and 13 show an alternative embodiment of anapplicator tool19 and a retainingmember16, respectively. In this embodiment, the retainingmember16 includes fourattachment tabs26 that detachably insert into four corresponding applicatortool attachment slots25. As shown, thetool19 and the retainingmember18 includefluid communication openings22 and18, respectively. It should be understood that various combinations of tabs, slots, alignment and openings can be incorporated into thetool19 and themember16 without deviating from the scope of the present invention.
• FIGS. 14athrough14eillustrate the steps of the claimed method of implanting an implant to an exposed surface of the cornea using the system of the present invention. The first step, shown inFIG. 14a, involves the surgical preparation of a portion of the outer surface of thecornea38 of the eye to form acorneal flap37, which remains attached to thecornea38 by way of ahinge36. This surgical step is commonly known in the art as a lamellar dissectomy, and is typically performed using a keratome (not shown). In a preferred embodiment, the flap is cut deeply enough to dissect the Bowman's membrane portion of thecornea38. Surgically preparing a corneal flap of 100 to 200 microns, typically 160 to 180 microns, operates to eliminate tension caused by the Bowman's membrane. This step reduces the possibility of implant extrusion due to pressure generated within thecornea38, which may be caused by the implant. As illustrated, it is preferable to leave thecorneal flap37 attached by way of ahinge36, thereby allowing theflap37 to be replaced in the same orientation as before the cut.
• After thesurface39 is prepared, the surgeon deposits theimplant40 onto thesurface39 using theapplicator19. To retrieve theapplicator tool19, the surgeon first removes the protective seal17 from around the bottle opening. Theimplant holding tool15 is then removed from within thebottle11 by removing the stopper12, which holds thestorage tool15. Thestorage tool15 is easily separated from the stopper12 by holding thetool15 about thebody portion21 and disengaging thetool15 from the now openedslot32. Next, thetool arm20 can be attached to ahandle30, and the retainingmember16 removed. Removing themember16 presents theimplant40 to the surgeon for implantation. The surgeon is able, therefore, to retrieve animplant40 from astorage bottle11 without having to use, at the risk of damaging or losing the implant, a grasping tool, such as tweezers or surgical forceps.
• The surgeon then properly aligns theimplant40 on theapplicator surface42 by preferably passing liquid through theopenings22. At this step, the surgeon may gently guide theimplant40 to its proper alignment on thesurface42 using acannula35, or other similar device. Theimplant40 is positioned on theapplicator surface42 by drawing off the fluid located intermediate to theimplant40 and theapplicator surface42. This can be done by placing a cotton swab, or other absorbent material, against the underside ofapplicator member45, which draws off the fluid throughopenings22.
• As shown inFIG. 14b, thecorneal flap37 is pulled away from thecornea implantation surface39. Theimplant40 is then positioned over thecornea implantation surface39 by holding theapplicator tool19 in a generally horizontal position over thesurface39 with theimplant40 facing thesurface39. As shown, theapplicator member45 has an arcuate shapedapplicator surface42, which matches the curved shaped of thecornea surface39. In this way, as illustrated inFIG. 14c, theapplicator member45 can be evenly placed over thecornea surface39, reducing trauma to thesurface39. Specifically, theimplant40 is evenly adhered to thesurface39, reducing the need for any manipulation of theimplant40 on thesurface39, which could traumatize the eye as is described above.
• Referring toFIG. 14d, theimplant40 is deposited onto thesurface39 by gently lifting theapplicator tool19 away from thesurface39. As shown, theimplant40 remains adhered to thesurface39. The use of acannula35 operable to pass a volume of fluid flow throughopening22, however, can be used to ensure proper deposition of theimplant40 ontosurface39. As shown inFIG. 14e, once the implant is deposited onto thesurface39, thecorneal flap37 is replaced.
• Various embodiments of the of the present invention have been described herein. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention as disclosed and claimed.

Claims (10)

1. A method of implanting a corneal implant, said method comprising the steps of:

separating a layer of corneal tissue to form an anterior internal surface and a posterior internal surface;

providing an implant applicator tool having a first end and a second end, said first end being adapted for holding a corneal implant, said second end adapted for handling the implant applicator tool, said first end having a retaining member detachably mounted to said first end;

removing said retaining member from said first end; and

depositing the implant on the posterior internal surface with the implant applicator tool.

2. The method ofclaim 1, wherein the first end has an applicator surface which is concave.

3. The method ofclaim 2, wherein the concave implant applicator surface has a radius of curvature that is greater than the radius of curvature of at least a portion of an implant surface.

4. The method ofclaim 2, wherein the applicator surface is a smooth or polished surface.

5. The method ofclaim 1, wherein at least a portion of the applicator surface is recessed.

6. The method ofclaim 1, wherein the applicator surface has at least one opening therethrough.

7. The method ofclaim 1, further including:

removing said implant applicator tool from a vessel having an opening, said vessel having a volume of fluid stored therein.

8. The method ofclaim 6, wherein the implant applicator tool is connected to a vessel stopper contoured to seal said vessel opening.

9. The method ofclaim 6 or7, further comprising the step of:

placing the implant applicator is the vessel so as to maintain the implant in fluid communication with the storage fluid contained therein.

10. The method ofclaim 1, wherein the depositing step comprises:

depositing the implant without using a separate device to place the implant on the posterior internal surface.

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