WO2004093760A1 - Kit packaging of drug delivery devices with useful adjunct items - Google Patents
Kit packaging of drug delivery devices with useful adjunct items Download PDFInfo
- Publication number
- WO2004093760A1 WO2004093760A1 PCT/US2004/008334 US2004008334W WO2004093760A1 WO 2004093760 A1 WO2004093760 A1 WO 2004093760A1 US 2004008334 W US2004008334 W US 2004008334W WO 2004093760 A1 WO2004093760 A1 WO 2004093760A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- container
- packaged
- storage
- kit
- fabricating
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0095—Packages or dispensers for prostheses or other implants
Definitions
- 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.
- 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.
- kits of items have been developed for certain types of surgery and treatment.
- U.S. Patent 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. Patent 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. Patent No. 4,523,679 (Paikoff et al.) teaches the fabrication of pre-sterilized medical procedure kit packages for surgical procedures.
- 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.
- Fig. 1 shows a flat layout of one embodiment of the kit.
- Fig. 2 shows a box layout of an alternate embodiment of the kit.
- 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.
- compartment 22 contains the delivery device and the injection device
- compartment 24 contains the packaged sutures
- compartment 26 contains the packaged suture needles.
- the layouts shown in the figures represent examples of many possible layouts for the invention.
- 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.
- 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.
- 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 surgeiy 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.
- 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.
- instruments 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.
- a third set of added compartments contains packaged eye covers, packaged dressings and wipes, and related materials.
- 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.
- 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.
- kits 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.
- 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.
- 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.
- kits include 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 TM filter material could cover the top of the tray. Larger kit with more items could use the clamshell arrangement described below.
- 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.
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/403,809 US20040200754A1 (en) | 2003-03-31 | 2003-03-31 | Kit packaging of drug delivery devices with useful adjunct items |
US10/403,809 | 2003-03-31 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2004093760A1 true WO2004093760A1 (en) | 2004-11-04 |
Family
ID=33130467
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2004/008334 WO2004093760A1 (en) | 2003-03-31 | 2004-03-18 | Kit packaging of drug delivery devices with useful adjunct items |
Country Status (2)
Country | Link |
---|---|
US (1) | US20040200754A1 (en) |
WO (1) | WO2004093760A1 (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005065602A3 (en) * | 2003-12-22 | 2005-10-27 | Bausch & Lomb | Drug delivery device with mechanical locking mechanism |
WO2007130072A3 (en) * | 2006-05-03 | 2008-04-17 | Light Sciences Oncology Inc | Light transmission system for photoreactive therapy |
WO2007127894A3 (en) * | 2006-04-28 | 2008-07-03 | Ondine Int Ltd | Photodisinfection delivery devices & methods |
WO2012166932A2 (en) * | 2011-06-01 | 2012-12-06 | The Regents Of The University Of California | Treating tear film disorders with mesenchymal stem cells |
US9067059B2 (en) | 2008-02-13 | 2015-06-30 | Alois Bissig | Light delivery device |
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US7762044B2 (en) * | 2003-01-27 | 2010-07-27 | Medtronic Vascular, Inc. | Packaging for stent delivery systems |
US7758825B2 (en) * | 2005-08-10 | 2010-07-20 | Cook Incorporated | Tray removal handle |
US20070255224A1 (en) * | 2006-04-07 | 2007-11-01 | James Ahern | Facet injection kit |
US10531859B2 (en) | 2008-01-02 | 2020-01-14 | Arcscan, Inc. | Components for a precision ultrasonic scanning apparatus for body parts |
US8758252B2 (en) | 2008-01-02 | 2014-06-24 | Arcscan, Inc. | Innovative components for an ultrasonic arc scanning apparatus |
US7972348B1 (en) | 2009-03-11 | 2011-07-05 | Deroyal Industries, Inc. | Single use scleral marker |
EP2477573B1 (en) | 2009-09-18 | 2015-07-01 | Biomet C.V. | Disposable orthopaedic surgery kit and components |
US10390867B2 (en) | 2009-09-18 | 2019-08-27 | Biomet C.V. | Bone plate system and method |
US20110226766A1 (en) * | 2010-03-16 | 2011-09-22 | Jay Baker | Stackable plastic trays |
US8387798B1 (en) * | 2012-04-27 | 2013-03-05 | Abdulmohsen E. A. H. Al-Terki | Mutiple oral and nasal surgical procedures method and kit |
US9597059B2 (en) | 2012-05-17 | 2017-03-21 | Arcscan, Inc. | Correcting for unintended motion for ultrasonic eye scans |
US9320427B2 (en) | 2012-07-09 | 2016-04-26 | Arcscan, Inc. | Combination optical and ultrasonic imaging of an eye |
US10220194B2 (en) * | 2012-11-28 | 2019-03-05 | Advanced Resin Therapeutics, Inc. | Dual chamber applicator |
CN103070737B (en) * | 2013-01-10 | 2014-11-05 | 山东省农业科学院畜牧兽医研究所 | Animal artificial insemination apparatus box |
JP6491652B2 (en) | 2013-10-16 | 2019-03-27 | シー・アール・バード・インコーポレーテッドC R Bard Incorporated | Catheter insertion tray with integrated instructions |
CA2977756A1 (en) * | 2014-02-24 | 2015-08-27 | Arcscan, Inc. | Disposable eyepiece system for an ultrasonic eye scanning apparatus |
US10888301B2 (en) | 2015-10-13 | 2021-01-12 | Arcscan, Inc. | Ultrasonic scanning apparatus |
US11426611B2 (en) | 2015-10-13 | 2022-08-30 | Arcscan, Inc. | Ultrasound therapeutic and scanning apparatus |
WO2018142220A2 (en) * | 2017-02-03 | 2018-08-09 | Bee Sight Limited | Medical apparatus and method for sterilizing medical apparatus |
AU2018243389B2 (en) | 2017-03-31 | 2023-06-08 | C.R. Bard, Inc. | Catheter insertion-tray systems and methods thereof |
GB2562217B (en) * | 2017-05-04 | 2020-01-15 | Herhealth Ltd | Improvements in or relating to packaging |
US11490983B2 (en) | 2018-04-24 | 2022-11-08 | C. R. Bard, Inc. | Catheterization packages and methods thereof |
US11612715B2 (en) | 2018-06-20 | 2023-03-28 | C. R. Bard, Inc. | Urinary catheter-insertion kits with integrated instructions for use and methods thereof |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4216860A (en) * | 1978-12-11 | 1980-08-12 | Electro-Catheter Corporation | Medical device container and method of manufacture |
US4522302A (en) * | 1984-03-05 | 1985-06-11 | Sterling Drug Inc. | Pre-sterilized medical procedure kit packages |
US4523679A (en) | 1984-03-05 | 1985-06-18 | Sterling Drug Inc. | Pre-sterilized medical procedure kit packages |
WO1999033512A2 (en) * | 1997-12-29 | 1999-07-08 | Alza Corporation | Implanter device for subcutaneous implants |
US5931303A (en) | 1996-09-30 | 1999-08-03 | Salvadori; Lawrence A. | Compact, pocketed wrapping for a medical procedure kit and process for using same |
US6116426A (en) | 1999-10-11 | 2000-09-12 | Slonim; Charles B. | Emergency eye kit |
US6426041B1 (en) | 1999-11-23 | 2002-07-30 | Sharon G. Smith | Multipurpose surgical instrument tray |
WO2002083021A1 (en) * | 2001-04-13 | 2002-10-24 | I-Flow Corporation | Sterile container for medical applications |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4128173A (en) * | 1975-10-28 | 1978-12-05 | Harrison Lazarus | Peritoneal fluid treatment apparatus, package and method |
-
2003
- 2003-03-31 US US10/403,809 patent/US20040200754A1/en not_active Abandoned
-
2004
- 2004-03-18 WO PCT/US2004/008334 patent/WO2004093760A1/en active Application Filing
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4216860A (en) * | 1978-12-11 | 1980-08-12 | Electro-Catheter Corporation | Medical device container and method of manufacture |
US4522302A (en) * | 1984-03-05 | 1985-06-11 | Sterling Drug Inc. | Pre-sterilized medical procedure kit packages |
US4523679A (en) | 1984-03-05 | 1985-06-18 | Sterling Drug Inc. | Pre-sterilized medical procedure kit packages |
US5931303A (en) | 1996-09-30 | 1999-08-03 | Salvadori; Lawrence A. | Compact, pocketed wrapping for a medical procedure kit and process for using same |
WO1999033512A2 (en) * | 1997-12-29 | 1999-07-08 | Alza Corporation | Implanter device for subcutaneous implants |
US6116426A (en) | 1999-10-11 | 2000-09-12 | Slonim; Charles B. | Emergency eye kit |
US6426041B1 (en) | 1999-11-23 | 2002-07-30 | Sharon G. Smith | Multipurpose surgical instrument tray |
WO2002083021A1 (en) * | 2001-04-13 | 2002-10-24 | I-Flow Corporation | Sterile container for medical applications |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005065602A3 (en) * | 2003-12-22 | 2005-10-27 | Bausch & Lomb | Drug delivery device with mechanical locking mechanism |
WO2007127894A3 (en) * | 2006-04-28 | 2008-07-03 | Ondine Int Ltd | Photodisinfection delivery devices & methods |
WO2007130072A3 (en) * | 2006-05-03 | 2008-04-17 | Light Sciences Oncology Inc | Light transmission system for photoreactive therapy |
US8057464B2 (en) | 2006-05-03 | 2011-11-15 | Light Sciences Oncology, Inc. | Light transmission system for photoreactive therapy |
US8235975B2 (en) | 2006-05-03 | 2012-08-07 | Light Sciences Oncology, Inc. | Light transmission system for photoreactive therapy |
USRE47491E1 (en) | 2006-05-03 | 2019-07-09 | Light Sciences Oncology, Inc. | Light transmission system for photoreactive therapy |
US9067059B2 (en) | 2008-02-13 | 2015-06-30 | Alois Bissig | Light delivery device |
WO2012166932A2 (en) * | 2011-06-01 | 2012-12-06 | The Regents Of The University Of California | Treating tear film disorders with mesenchymal stem cells |
WO2012166932A3 (en) * | 2011-06-01 | 2013-01-31 | The Regents Of The University Of California | Treating tear film disorders with mesenchymal stem cells |
Also Published As
Publication number | Publication date |
---|---|
US20040200754A1 (en) | 2004-10-14 |
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