Kit packaging of drug delivery devices with useful adjunct items

Abstract

A kit containing a complete set of items needed to implant a sustained ocular or intraocular drug delivery system, including, but not limited to, injection devices, topical and injectable medications, surgical instruments, sutures and suturing needles, and eye covers. Provision of the set of items in a kit simplifies preparation for insertion of drug delivery means, reduces the cost of such preparation, reduces the likelihood of errors in preparation or selection of appropriate items during surgery, reduces the complexity of maintenance of sterile conditions, and ultimately reduces the cost of delivering ocular care.

Description

FIELD OF THE INVENTION

[0001] This invention relates to the sterile packaging of medical implements, medications, and supporting items for surgery, and more specifically to the sterile packaging of medical implements, medications, and supporting items together in a kit to be used for ocular and intraocular surgery.

BACKGROUND OF THE INVENTION

[0002] The sterile packaging of items in a kit for use in medical treatment of a patient has become increasingly important for the following reasons: 1) the increasing complexity and variety of treatments available makes assembly of individual items a labor-intensive and error-prone task; 2) medical personnel need to meet an elevated standard for sterility due partly to the increased presence of antibiotic-resistant microbes; 3) the availability of lower-cost methods of fabricating, assembling, and packaging surgical and other treatment items more than offsets the costs of having staff locate, assemble, and lay out the same items for a treatment.

[0003] Such kits of items have been developed for certain types of surgery and treatment. U.S. Pat. No. 6,426,041 (Smith) teaches the fabrication of a multipurpose surgical instrument tray to simplify and speed presentation of any of a kit of instruments during surgery, but omits any further packaging. U.S. Pat. No. 5,931,303 (Salvadori) teaches fabrication of a compact, pocketed wrapping for a medical procedure kit, and a process for using the kit. U.S. Pat. No. 4,523,679 (Paikoff et al.) teaches the fabrication of pre-sterilized medical procedure kit packages for surgical procedures. U.S. Pat. No. 6,116,426 (Slonim) teaches an emergency medical kit containing instruments, supplies, and other items for the treatment of eye injuries. No instances of the prior art teach a kit for insertion of a capsule or suture tab for sustained ocular drug delivery. Such a kit would simplify surgical preparation and execution for ocular treatment, and cut the costs of delivering care.

SUMMARY OF THE INVENTION

[0004] The invention packages in kit form a complete set of items needed to implant a sustained ocular or intraocular drug delivery system, including, but not limited to, injection devices, topical and injectable medications, surgical instruments, sutures and suturing needles, and eye covers. The resulting kit simplifies preparation for insertion of drug delivery means, reduces the cost of such preparation, reduces the likelihood of errors in preparation or selection of appropriate items during surgery, reduces the complexity of maintenance of sterile conditions, and ultimately reduces the cost of delivering ocular care at a time when the frequency of insertion of ocular and intraocular drug delivery implants is growing.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005] FIG. 1 shows a flat layout of one embodiment of the kit.

[0006] FIG. 2 shows a box layout of an alternate embodiment of the kit.

DETAILED DESCRIPTION OF THE INVENTION

[0007] The invention is a portable kit having sterile seals for performing ocular or intraocular implanting of an ocular drug delivery system. The invention includes as its required components a portable protective container, a storage compartment in the container containing both a packaged injectable ocular drug delivery device such as a suture tab with attached capsule and a packaged injection device, and one or more compartments in the container holding packaged sutures and packaged suture needles for attaching the suture tab ocularly. See FIGS. 1 and 2. FIG. 1 shows the layout of typical compartments for the required components in a larger flat container 10, where compartment 12 contains the delivery device and the injection device, compartment 14 contains the packaged sutures, and compartment 16 contains the packaged suture needles. FIG. 2 shows the layout typical compartments for the required components in a smaller box-shaped container 20 with lid 21, where compartment 22 contains the delivery device and the injection device, compartment 24 contains the packaged sutures, and compartment 26 contains the packaged suture needles. The layouts shown in the figures represent examples of many possible layouts for the invention.

[0008] The kit's portable protective container may be formed either as a blister pack or as a clamshell, made of sterilization-safe plastics such as high-density polyethylene (HDPE), polyethylene terephthalate (PET or PETg), or polycarbonate. These plastics are not harmed by standard sterilization methods such as ethylene oxide, gamma radiation, electron beam radiation, or autoclaving. The container may have a latch and hinge, allowing closing and locking, and opening and unlocking. A protective seal, added once the kit is filled initially with its contents, protects all the contents from contamination or damage due to accidental opening and provides a first level of assurance of sterility of the contents. Two layers of protective wrappers surrounding the container provide for proper maintenance of sterile conditions when transporting the kit into a sterile environment for use. Optional external features of the container and outer wrapper such as a handle, grip, or strap provide for ease of carrying and storage.

[0009] The kit incorporates additional storage compartments for items usually required for ocular implanting of a drug delivery device. This second set of compartments may be incorporated in the kit as a separate layer (‘tray’) or group. This separation allows the surgeon or the hospital to choose either a more basic kit requiring separate provision of medications, instruments, and other surgical items, or a more complete kit including most or all medications, instruments, and other items needed for ocular implantation of a drug delivery system.

[0010] One set of the additional compartments contains medications, both injectable and topical, in sterile packaged form ready to use. The medications to be used include those specific to ocular surgery such as cycloplegics, mydriatics, and miotics; those anti-infectives and anti-inflammatory agents and steroids compatible with ocular use; and ocular anesthetics, irrigating solutions, lubricants, sterilizers, and external cleansers.

[0011] A second set of additional compartments contains packaged, sterilized surgical instruments of use in ocular surgery for implanting an ocular drug delivery device. The instruments to be used include cannulas, trocars, keratomes, scalpels, forceps, hooks, and scissors. For the ocular surgery needed for implantation of an ocular drug delivery system, instruments must be available to perform incisions, dilations, and positioning, implanting, and suturing of the drug delivery system.

[0012] A third set of added compartments contains packaged eye covers, packaged dressings and wipes, and related materials.

[0013] The fabrication of the kit begins with the making of the portable protective container by injection molding or other process suitable for use with the plastics to be used. The container may take the form of a blister pack or a clamshell. The container may be fabricated in one piece with a hinge, may have separate base and lid with a snap-in hinge, or may be fabricated as a set of ‘trays’ of compartments with a separate lid. Compartments in the container are either molded into the container or its parts in the initial fabrication process, or are separately molded to fit snugly within the container.

[0014] The required section of the container, that is, the compartments for the packaged injectable ocular drug delivery device and the packaged sutures and packaged suture needles, is set apart from the remaining three sections of compartments used for medications, instruments, and dressings. Once each section of compartments is installed in the kit, it is provisioned with the desired items for each compartment.

[0015] When all desired and required items are stored in the kit, the kit is closed. A protective seal is added to guarantee an untampered kit, and the kit is then sealed inside inner and outer protective seals to allow for sterile handling as required.

[0016] In one embodiment the kit has a minimal number of components that includes an inserter and an intraocular drug in its intraocular container. The drug container may be as small as one or several millimeter in size and the kit may include one or more drug container is different sizes. As an option, the inserter may be preloaded with a predetermined quantity of intraocular drug in its suitable intraocular container. The inserter is about the size of a ball point pen and is elongated with an opening and holding means at that one end for holding the intraocular drug container. The other end of inserter has a release mechanism that is operable to release the intraocular drug container from the one end. The inserter and the drug container may be enclosed in a sealed sterile package that could include one or more pouches of sterile material. Another package for the kit includes a plastic tray with compartments for holding the inserter, the drug containers, and other items such as sutures. The tray is sealed with medical paper or other suitable porous material that has pores large enough to allow passage of sterilizing gas but small enough to exclude microbes. Typical material such as Tyvek™ filter material could cover the top of the tray. Larger kit with more items could use the clamshell arrangement described below.

[0017] The container may have an external grip, handle, or strap added for ease of carrying and storage. The horizontal dimensions of the kit's portable protective container are in the embodiment outlined in FIG. 1 approximately eight inches by eleven inches, and in the embodiment outlined in FIG. 2 approximately four inches by five and a half inches. The vertical dimension of the kit's container is between two and three inches per layer of compartments.

Claims

1. A kit for performing ocular or intraocular implanting of an ocular drug delivery system, comprising:

a portable protective container; and

at least one first compartment in the container for storage of a packaged injectable ocular drug delivery device and a packaged injection device, containing the packaged injectable ocular drug delivery device and the packaged injection device.

2. The kit of claim 1 further comprising at least one second compartment in the container for storage of sutures and suture needles, containing one or more packaged sutures and one or more packaged suture needles.

3. The kit of claim 1 wherein the portable protective container further comprises:

a protective seal to preserve sterility of the contents of the container;

a base for the container, divided into the compartments of the container;

a lid for protecting the contents of the compartments of the container;

means for fastening the lid to the base;

means for opening, closing, locking, and unlocking the container; and

means for carrying the container securely.

4. The kit of claim 1 wherein the container comprises one or more pouches, each pouch comprising a sterile sealed compartment.

5. The kit of claim 1 wherein the package is a tray with one or more compartments with medical paper or filter material with pores large enough to admit sterilizing gas and small enough to exclude microbes.

6. The kit of claim 1 wherein the portable protective container further comprises:

an outer protective wrapper for protection during transportation and storage; and

an inner protective wrapper for maintenance of general sterility of kit contents.

7. The kit of claim 1 wherein the portable protective container further comprises a blister pack comprised of one or more plastics capable of surgical sterilization by ethylene oxide, gamma radiation, electron beam radiation, autoclave, or other methods meeting generally accepted surgical standards.

8. The kit of claim 1 wherein the portable protective container further comprises a blister pack comprised of one or more plastics selected from the group consisting of high-density polyethylene (HDPE), polyethylene terephthalate (PET or PETg), polycarbonate, polyvinyl chloride (PVC), and styrene.

9. The kit of claim 1 wherein the portable protective container further comprises a clamshell package comprised of one or more plastics capable of surgical sterilization by ethylene oxide, gamma radiation, electron beam radiation, autoclave, or other methods meeting generally accepted surgical standards.

10. The kit of claim 1 wherein the portable protective container further comprises a clamshell package comprised of one or more plastics selected from the group consisting of high-density polyethylene (HDPE), polyethylene terephthalate (PET or PETg), polycarbonate, polyvinyl chloride (PVC), and styrene.

11. The kit of claim 1 further comprising:

at least one third compartment in the container for storage of eye covers and dressings, containing one or more packaged eye covers;

at least one fourth compartment in the container for storage of medications; and

at least one fifth compartment in the container for storage of surgical instruments.

12. The kit of claim 8 wherein the at least one fourth compartment in the container for storage of medications contains one or more packaged medications from the group consisting of cycloplegics, mydriatics, and miotics.

13. The kit of claim 11 wherein the at least one fourth compartment in the container for storage of medications contains one or more packaged medications from the group consisting of anti-infectives, anti-inflammatory agents, steroids, and combination products containing anti-infectives and anti-inflammatory agents.

14. The kit of claim 11 wherein the at least one fourth compartment in the container for storage of medications contains one or more packaged medications from the group consisting of anesthetics, irrigating solutions, lubricants, sterilizers, and external cleansers.

15. The kit of claim 11 wherein the at least one fifth compartment in the container for storage of surgical instruments contains one or more packaged surgical instruments from the group consisting of cannulas, trocars, keratomes, scalpels, forceps, hooks, and scissors.

16. A method for fabricating a kit for performing ocular or intraocular implanting of an ocular drug delivery system, comprising the steps of:

fabricating a portable protective container;

fabricating at least one first compartment in the container for storage of a packaged injectable ocular drug delivery device, containing the packaged injectable ocular drug delivery device and a packaged injection device; and

fabricating at least one second compartment in the container for storage of sutures and suture needles, containing one or more packaged sutures and one or more packaged suture needles.

17. The method of claim 16 wherein the step of fabricating the portable protective container further comprises the steps of:

fabricating a protective seal to preserve sterility of the contents of the container;

fabricating a base for the container, divided into the compartments of the container;

fabricating a lid for protecting the contents of the compartments of the container;

fabricating a means for fastening the lid to the base;

fabricating a means for opening, closing, locking, and unlocking the container; and

fabricating a means for carrying the container securely.

18. The method of claim 16 wherein the step of fabricating the portable protective container further comprises the steps of:

fabricating an outer protective wrapper for protection during transportation and storage; and

fabricating an inner protective wrapper for maintenance of general sterility of kit contents.

19. The method of claim 16 wherein the step of fabricating the portable protective container further comprises the step of fabricating a blister pack comprised of one or more plastics capable of surgical sterilization by ethylene oxide, gamma radiation, electron beam radiation, autoclave, or other methods meeting generally accepted surgical standards.

20. The method of claim 16 wherein the step of fabricating the portable protective container further comprises the step of fabricating a blister pack comprised of one or more plastics selected from the group consisting of high-density polyethylene (HDPE), polyethylene terephthalate (PET or PETg), polycarbonate, polyvinyl chloride (PVC), and styrene.

21. The method of claim 16 wherein the step of fabricating the portable protective container further comprises the step of fabricating a clamshell package comprised of one or more plastics capable of surgical sterilization by ethylene oxide, gamma radiation, electron beam radiation, autoclave, or other methods meeting generally accepted surgical standards.

22. The method of claim 16 wherein the step of fabricating the portable protective container further comprises the step of fabricating a clamshell package comprised of one or more plastics selected from the group consisting of high-density polyethylene (HDPE), polyethylene terephthalate (PET or PETg), polycarbonate, polyvinyl chloride (PVC), and styrene.

23. The method of claim 16 further comprising the steps of:

fabricating at least one third compartment in the container for storage of eye covers and dressings, containing one or more packaged eye covers.

fabricating at least one fourth compartment in the container for storage of medications; and

fabricating at least one fifth compartment in the container for storage of surgical instruments.

24. The method of claim 23 wherein the step of fabricating the at least one fourth compartment in the container for storage of medications further comprises the step of storing one or more packaged medications from the group consisting of cycloplegics, mydriatics, and miotics in the at least one fourth compartment in the container.

25. The method of claim 23 wherein the step of fabricating the at least one fourth compartment in the container for storage of medications further comprises the step of storing one or more packaged medications from the group consisting of anti-infectives, anti-inflammatory agents, steroids, and combination products containing anti-infectives and anti-inflammatory agents in the at least one fourth compartment in the container.

26. The method of claim 23 wherein the step of fabricating the at least one fourth compartment in the container for storage of medications further comprises the step of storing one or more packaged medications from the group consisting of anesthetics, irrigating solutions, lubricants, sterilizers, and external cleansers in the at least one fourth compartment in the container.

27. The method of claim 23 wherein the step of fabricating the at least one fifth compartment in the container for storage of surgical instruments further comprises the step of storing one or more packaged surgical instruments from the group consisting of cannulas, trocars, keratomes, scalpels, forceps, hooks, and scissors in the at least one fifth compartment in the container.

28. A kit for performing ocular or intraocular implanting of an ocular drug delivery system, comprising:

a portable protective container;

means for storage of a packaged injectable ocular drug delivery device and a packaged injection device, containing the packaged injectable ocular drug delivery device and the packaged injection device; and

means for storage of sutures and suture needles, containing one or more packaged sutures and one or more packaged suture needles.

29. The kit of claim 28 wherein the portable protective container further comprises:

means for preserving sterility of the contents of the container;

a base for the container, divided into the compartments of the container;

means for protecting the contents of the compartments of the container;

means for opening, closing, locking, and unlocking the container; and

means for carrying the container securely.

30. The kit of claim 28 wherein the portable protective container further comprises:

means for protection during transportation and storage; and

means for maintenance of general sterility of kit contents.

31. The kit of claim 28 wherein the portable protective container further comprises storage means capable of surgical sterilization by ethylene oxide, gamma radiation, electron beam radiation, autoclave, or other methods meeting generally accepted surgical standards.

32. The kit of claim 28 further comprising:

means for storage of eye covers and dressings, containing one or more packaged eye covers.

means for storage of medications; and

means for storage of surgical instruments.

33. The kit of claim 32 wherein the means for storage of medications contains one or more packaged medications from the group consisting of cycloplegics, mydriatics, and miotics.

34. The kit of claim 32 wherein the means for storage of medications contains one or more packaged medications from the group consisting of anti-infectives, anti-inflammatory agents, steroids, and combination products containing anti-infectives and anti-inflammatory agents.

35. The kit of claim 32 wherein the means for storage of medications contains one or more packaged medications from the group consisting of anesthetics, irrigating solutions, lubricants, sterilizers, and external cleansers.

36. The kit of claim 32 wherein the means for storage of surgical instruments contains one or more packaged surgical instruments from the group consisting of a cannulas, trocars, keratomes, scalpels, forceps, hooks, and scissors.

37. The kit of claim 32 wherein the means for storage of an ocular drug delivery system contains one or more packaged suture tabs attached to an ocular drug delivery system.