CA1230860A - Sealable container for packaging medical articles in sterile condition - Google Patents
Sealable container for packaging medical articles in sterile conditionInfo
- Publication number
- CA1230860A CA1230860A CA000466179A CA466179A CA1230860A CA 1230860 A CA1230860 A CA 1230860A CA 000466179 A CA000466179 A CA 000466179A CA 466179 A CA466179 A CA 466179A CA 1230860 A CA1230860 A CA 1230860A
- Authority
- CA
- Canada
- Prior art keywords
- package
- vent
- inner package
- sealable
- sheet material
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
-
- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/206—Ethylene oxide
-
- 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
- A61B2050/3006—Nested casings
-
- 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
- A61B50/33—Trays
Abstract
SEALABLE CONTAINER FOR PACKAGING MEDICAL
ARTICLES IN STERILE CONDITION
ABSTRACT
There is described a double sterile package for packaging metal articles in a sterile condition which can be sterilized in one ethylene oxide sterilization cycle.
The package comprises:
(a) a sealable inner package formed of impervious sheet material, said inner package being arranged and constructed to contain said medical product, wherein the inner package has a heat sealable vent at a predetermined location thereon; and (b) a sealable outer package formed of sheet material that is impervious to bacteria, at least a portion of the outer package being formed of sheet material that is previous to sterilizing gas, the outer package being arranged and constructed to receive said inner package therein and to snugly hold the inner package in a predetermined position, wherein the outer package contains means positioned to be adjacent said vent when the inner package is contained in the outer package in said predetermined position, sand means being capable of transmitting sufficient heat therethrough to heat seal said vent without said means itself being heat sealed to said inner package.
ARTICLES IN STERILE CONDITION
ABSTRACT
There is described a double sterile package for packaging metal articles in a sterile condition which can be sterilized in one ethylene oxide sterilization cycle.
The package comprises:
(a) a sealable inner package formed of impervious sheet material, said inner package being arranged and constructed to contain said medical product, wherein the inner package has a heat sealable vent at a predetermined location thereon; and (b) a sealable outer package formed of sheet material that is impervious to bacteria, at least a portion of the outer package being formed of sheet material that is previous to sterilizing gas, the outer package being arranged and constructed to receive said inner package therein and to snugly hold the inner package in a predetermined position, wherein the outer package contains means positioned to be adjacent said vent when the inner package is contained in the outer package in said predetermined position, sand means being capable of transmitting sufficient heat therethrough to heat seal said vent without said means itself being heat sealed to said inner package.
Description
go SEALABLE CONTAINER FOR PACKAGING MEDICAL
ARTICLES IN STERILE CONDITION
The invention relates to a sealable package for packaging medical articles in a sterile condition, and is particularly adapted for packaging articles for ethylene oxide sterilization.
BACKGROUND OF THE INVENTION
-One type of packaging for sterile medical devices uses a double sterile package having a sealed primary package that contains the device and a secondary sealed package.
The primary package is contained inside the secondary package, with the contents of both packages being in a sterile condition. Certain types of materials from which medical devices are made must be sterilized by ethylene oxide, because the preferred mode of sterilizing via gamma radiation causes excessive degradation of such materials. Polypropylene and synthetic absorbable polyp mews such as polyglycolic acid and poly-(p-dioxanone) are illustrative of such materials that undergo an undesir-able degree of degradation upon exposure to a sufficient dose of gamma radiation to effect sterilization.
A typical package of this type affiliated for ethylene oxide sterilization employs a sealed metal foil pack as the primary package, and as the secondary package a relatively rigid tray having a cover of a material that is impervious to bacteria but which is previous to ethylene oxide gas. Spun bonded polyethylene (such as Dupont TYVEK) is illustrative of such materials. The So sterilization procedure used with such a package would ordinarily employ two cycles. Initially, the foil pact containing the medical device to be sterilized is partially sealed, is then sterilized with ethylene oxide gas, and the seal is completed in a sterile atmosphere.
The foil pack is then sealed in the secondary package containing an ethylene oxide-pervious cover, and the package as a whole is then subjected to a second ethylene oxide sterilization step.
This invention provides a double sterile package that can be sterilized by ethylene oxide gas in one sterilization cycle.
BRIEF SUMMARY OF THE INVENTION
___ __ The invention provides a package for encasing a sterile medical product, which comprises:
(a) a sealable inner package formed of impervious sheet material, said inner package being arranged and constructed to contain said medical product, wherein the inner package has a heat sealable vent at a predetermined location thereon; and (b) a sealable outer package formed ox sheet material that is impervious to bacteria, at least a portion of the outer package being formed of sheet material that is previous to sterilizing gas, the outer package being arranged and constructed to receive said inner package therein and to snugly hold the inner package in a predetermined position, wherein the outer package contains means positioned to be adjacent said vent when the inner package is contained in the outer package in said predetermined position, said means being capable of transmitting sù~ficient heat there through to heat seal said vent without said means itself being heat sealed to said inner package.
THE PRIOR ART
s Commutes et at., US. Patent No. 3,892,058, disclose a process for sterilizing a container composed of a metal foil layer and a heat sealable resin film 10 Daly et at., US. Patent No. 4,177,620, disclose a method for sterilizing a package which has a plastic member heat sealed around three sides to a paper member.
Schuster, US. Patent No. 4,n22,324, discloses a sealed container which is sterilized after an article has been placed therein. The container comprises a bottom tray portion, a flexible cover portion including a bacteria-impermeable panel means and a passage means, and a bacteria-impermeable, sterilizing vapor-permeable membrane.
Kemble, US. Patent Jo. 3,613,879, is an illustration of a conventional suture package having an inner and an outer envelope which is sterilized by ethylene oxide, US
ROUGH DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view of a package embodying the principles of the invention;
Fig. 2 is an exploded perspective view of the package of Fig. l;
Fig. 3 is a cross-sectional side view of a portion of the package of Fig. 1 showing the vent before it is sealed;
Fig. 4 is a view similar to Fig. 3 showing the vent sealed; and Fig. 5 is a perspective view of the package of Fig. 1 with the cover sheet removed.
DETAILED DESCRIPTION OF THE INVENTION
-Referring now to the drawings, in Figs. 1 and 2, there is shown a package I for a sterile medical product ouch as a multiple clip applier for applying absorbable ligating clips made of a polymeric material such as polydioxanone that cannot be sterilized by gamma radiation, but which must be sterilized by a sterilizing gas such as ethylene oxide. The multiple clip applier is shown in phantom in Fig. 2 as 12. The package 10 is composed of an inner package 14 and an outer package 16. The inner package 14 is made of a material such as metal foil that is come pletely sealed except for a vent 18 at one end thereof.
Conveniently, the inner package 14 is composed of a shaped bottom portion 20 and a relatively flat cover sheet 22. The cover sheet 22 is sealed to the shaped bottom portion 20 completely around the edge 24, except at the vent 18. However, there is a layer of heat seal-able material applied to either the cover sheet 22 and/orthe shaped bottom portion 20 in the area of the vent 18 so that the vent 18 can be heat sealed at an appropriate time in the sterilization cycle.
The outer package 16 is composed of a fairly rigid tray 26 composed of a thermoformable material such as high density polyethylene. The tray 26 is shaped so as to receive the inner package 14 and hold it snugly in a predetermined position, as is shown in the drawings (e.g., Fig. 5). The outer package 16 also includes a sterilizing gas-pervious cover sheet 28, which is . ,.
1~3~
impervious to bacteria, such as spun bonded polyethylene (for instance Dupont's TOKYO).
The gas previous cover sheet 28 contains a metal foil "window 30 which is located such that when the inner package I is placed in the tray 26, and the gas previous cover sheet 28 is sealed onto the tray 26, the metal foil window 30 will be positioned just over the vent I (see -Figs. 3 and 4). Therefore, when the package 10 is being employed to contain a medical article such as the multiple clip applier 12 shown in the drawings, the applier 12 is first sealed into the inner package 14, leaving only the vent 18 unsealed, the inner package 14 is placed in the tray 26 in position as shown in Fig. 5, lo and then the gas previous cover sheet 28 is heat sealed completely onto the top of the tray 26~ The entire package 10 is then exposed to an atmosphere of ethylene oxide, which permeates through the gas previous cover sheet 28 and into the interior of both the outer package 16 and through the vent 18 into the interior of the inner package 14 to thereby sterilize the medical device 12 contained therein. At the end of the ethylene oxide sterilization cycle, the sterilized package 10 is then removed to the atmosphere, which need not be sterile, and then the vent 18 is heat sealed by conventional means such as is shown in Figs. 3 and 4 wherein the package 10 is positioned such that the portion just under the vent 18 is placed on a rubber sealing base 32 and a hot sealing dye 34 is applied to the metal foil window 30 to have the heat transmitted through the metal foil window 30 and to heat seal the vent 18.
By following the principles of this invention, it is seen that one ethylene oxide sterilization cycle can be eliminated frill the prior sterilization procedure that was discussed above in the background of the Invention F,TH 598 section of this application.
* Trademark
ARTICLES IN STERILE CONDITION
The invention relates to a sealable package for packaging medical articles in a sterile condition, and is particularly adapted for packaging articles for ethylene oxide sterilization.
BACKGROUND OF THE INVENTION
-One type of packaging for sterile medical devices uses a double sterile package having a sealed primary package that contains the device and a secondary sealed package.
The primary package is contained inside the secondary package, with the contents of both packages being in a sterile condition. Certain types of materials from which medical devices are made must be sterilized by ethylene oxide, because the preferred mode of sterilizing via gamma radiation causes excessive degradation of such materials. Polypropylene and synthetic absorbable polyp mews such as polyglycolic acid and poly-(p-dioxanone) are illustrative of such materials that undergo an undesir-able degree of degradation upon exposure to a sufficient dose of gamma radiation to effect sterilization.
A typical package of this type affiliated for ethylene oxide sterilization employs a sealed metal foil pack as the primary package, and as the secondary package a relatively rigid tray having a cover of a material that is impervious to bacteria but which is previous to ethylene oxide gas. Spun bonded polyethylene (such as Dupont TYVEK) is illustrative of such materials. The So sterilization procedure used with such a package would ordinarily employ two cycles. Initially, the foil pact containing the medical device to be sterilized is partially sealed, is then sterilized with ethylene oxide gas, and the seal is completed in a sterile atmosphere.
The foil pack is then sealed in the secondary package containing an ethylene oxide-pervious cover, and the package as a whole is then subjected to a second ethylene oxide sterilization step.
This invention provides a double sterile package that can be sterilized by ethylene oxide gas in one sterilization cycle.
BRIEF SUMMARY OF THE INVENTION
___ __ The invention provides a package for encasing a sterile medical product, which comprises:
(a) a sealable inner package formed of impervious sheet material, said inner package being arranged and constructed to contain said medical product, wherein the inner package has a heat sealable vent at a predetermined location thereon; and (b) a sealable outer package formed ox sheet material that is impervious to bacteria, at least a portion of the outer package being formed of sheet material that is previous to sterilizing gas, the outer package being arranged and constructed to receive said inner package therein and to snugly hold the inner package in a predetermined position, wherein the outer package contains means positioned to be adjacent said vent when the inner package is contained in the outer package in said predetermined position, said means being capable of transmitting sù~ficient heat there through to heat seal said vent without said means itself being heat sealed to said inner package.
THE PRIOR ART
s Commutes et at., US. Patent No. 3,892,058, disclose a process for sterilizing a container composed of a metal foil layer and a heat sealable resin film 10 Daly et at., US. Patent No. 4,177,620, disclose a method for sterilizing a package which has a plastic member heat sealed around three sides to a paper member.
Schuster, US. Patent No. 4,n22,324, discloses a sealed container which is sterilized after an article has been placed therein. The container comprises a bottom tray portion, a flexible cover portion including a bacteria-impermeable panel means and a passage means, and a bacteria-impermeable, sterilizing vapor-permeable membrane.
Kemble, US. Patent Jo. 3,613,879, is an illustration of a conventional suture package having an inner and an outer envelope which is sterilized by ethylene oxide, US
ROUGH DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view of a package embodying the principles of the invention;
Fig. 2 is an exploded perspective view of the package of Fig. l;
Fig. 3 is a cross-sectional side view of a portion of the package of Fig. 1 showing the vent before it is sealed;
Fig. 4 is a view similar to Fig. 3 showing the vent sealed; and Fig. 5 is a perspective view of the package of Fig. 1 with the cover sheet removed.
DETAILED DESCRIPTION OF THE INVENTION
-Referring now to the drawings, in Figs. 1 and 2, there is shown a package I for a sterile medical product ouch as a multiple clip applier for applying absorbable ligating clips made of a polymeric material such as polydioxanone that cannot be sterilized by gamma radiation, but which must be sterilized by a sterilizing gas such as ethylene oxide. The multiple clip applier is shown in phantom in Fig. 2 as 12. The package 10 is composed of an inner package 14 and an outer package 16. The inner package 14 is made of a material such as metal foil that is come pletely sealed except for a vent 18 at one end thereof.
Conveniently, the inner package 14 is composed of a shaped bottom portion 20 and a relatively flat cover sheet 22. The cover sheet 22 is sealed to the shaped bottom portion 20 completely around the edge 24, except at the vent 18. However, there is a layer of heat seal-able material applied to either the cover sheet 22 and/orthe shaped bottom portion 20 in the area of the vent 18 so that the vent 18 can be heat sealed at an appropriate time in the sterilization cycle.
The outer package 16 is composed of a fairly rigid tray 26 composed of a thermoformable material such as high density polyethylene. The tray 26 is shaped so as to receive the inner package 14 and hold it snugly in a predetermined position, as is shown in the drawings (e.g., Fig. 5). The outer package 16 also includes a sterilizing gas-pervious cover sheet 28, which is . ,.
1~3~
impervious to bacteria, such as spun bonded polyethylene (for instance Dupont's TOKYO).
The gas previous cover sheet 28 contains a metal foil "window 30 which is located such that when the inner package I is placed in the tray 26, and the gas previous cover sheet 28 is sealed onto the tray 26, the metal foil window 30 will be positioned just over the vent I (see -Figs. 3 and 4). Therefore, when the package 10 is being employed to contain a medical article such as the multiple clip applier 12 shown in the drawings, the applier 12 is first sealed into the inner package 14, leaving only the vent 18 unsealed, the inner package 14 is placed in the tray 26 in position as shown in Fig. 5, lo and then the gas previous cover sheet 28 is heat sealed completely onto the top of the tray 26~ The entire package 10 is then exposed to an atmosphere of ethylene oxide, which permeates through the gas previous cover sheet 28 and into the interior of both the outer package 16 and through the vent 18 into the interior of the inner package 14 to thereby sterilize the medical device 12 contained therein. At the end of the ethylene oxide sterilization cycle, the sterilized package 10 is then removed to the atmosphere, which need not be sterile, and then the vent 18 is heat sealed by conventional means such as is shown in Figs. 3 and 4 wherein the package 10 is positioned such that the portion just under the vent 18 is placed on a rubber sealing base 32 and a hot sealing dye 34 is applied to the metal foil window 30 to have the heat transmitted through the metal foil window 30 and to heat seal the vent 18.
By following the principles of this invention, it is seen that one ethylene oxide sterilization cycle can be eliminated frill the prior sterilization procedure that was discussed above in the background of the Invention F,TH 598 section of this application.
* Trademark
Claims (6)
1. A package for encasing a sterile medical product, which comprises:
(a) a sealable inner package formed of impervious sheet material, said inner package being arranged and constructed to contain said medical product, wherein the inner package has a heat sealable vent at a predetermined location thereon; and (b) a sealable outer package formed of sheet material that is impervious to bacteria, at least a portion of the outer package being formed of sheet material that is pervious to sterilizing gas, the outer package being arranged and constructed to receive said inner package therein and to snugly hold the inner package in a predetermined position, wherein the outer package contains means positioned to be adjacent said vent when the inner package is contained in the outer package in said predetermined position, said means being capable of transmitting sufficient heat therethrough to heat seal said vent without said means itself being heat sealed to said inner package.
(a) a sealable inner package formed of impervious sheet material, said inner package being arranged and constructed to contain said medical product, wherein the inner package has a heat sealable vent at a predetermined location thereon; and (b) a sealable outer package formed of sheet material that is impervious to bacteria, at least a portion of the outer package being formed of sheet material that is pervious to sterilizing gas, the outer package being arranged and constructed to receive said inner package therein and to snugly hold the inner package in a predetermined position, wherein the outer package contains means positioned to be adjacent said vent when the inner package is contained in the outer package in said predetermined position, said means being capable of transmitting sufficient heat therethrough to heat seal said vent without said means itself being heat sealed to said inner package.
2. The package of claim 1 wherein said outer package is at least partially constructed of spun-bonded polyolefin.
3. The package of claim 2 wherein the spun-bonded polyolefin is spun-bonded polyethylene.
4. The package of claim 1 wherein said means comprises metal foil.
5. The package of claim 2 wherein said means comprises metal foil.
6. The package of claim 3 wherein said means comprises metal foil.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US552,511 | 1983-11-16 | ||
| US06/552,511 US4482053A (en) | 1983-11-16 | 1983-11-16 | Sealable container for packaging medical articles in sterile condition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1230860A true CA1230860A (en) | 1987-12-29 |
Family
ID=24205654
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000466179A Expired CA1230860A (en) | 1983-11-16 | 1984-10-24 | Sealable container for packaging medical articles in sterile condition |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US4482053A (en) |
| EP (1) | EP0142378B1 (en) |
| JP (1) | JPS60123372A (en) |
| AU (1) | AU564514B2 (en) |
| BR (1) | BR8405822A (en) |
| CA (1) | CA1230860A (en) |
| DE (1) | DE3471640D1 (en) |
| DK (1) | DK543784A (en) |
| ZA (1) | ZA848922B (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3229813A (en) * | 1959-05-08 | 1966-01-18 | Johnson & Johnson | Sterile package |
| US3815315A (en) * | 1971-04-29 | 1974-06-11 | American Cyanamid Co | Ethylene oxide sterilization of moisture sensitive surgical elements |
| US3819106A (en) * | 1972-04-12 | 1974-06-25 | S Schuster | Sample bag |
| US4057144A (en) * | 1975-01-17 | 1977-11-08 | Schuster Samuel J | High strength bag for storing materials in sterile condition |
| GB1531606A (en) * | 1976-08-02 | 1978-11-08 | Propper Mfg Co Inc | Sterile packs |
| US4177620A (en) * | 1977-03-23 | 1979-12-11 | Faser Industries | Method of forming a sterilizable package with tear-off indicators |
| FR2428583B1 (en) * | 1978-06-16 | 1985-07-12 | Somycel Sa | STERILIZABLE BAG MADE OF A PLASTIC SHEET FOR THE PRODUCTION OF MUSHROOM WHITE |
| US4176746A (en) * | 1978-07-10 | 1979-12-04 | Arvey Corporation | Gusset pouch with integral seal support and method of making same |
| US4203520A (en) * | 1978-08-28 | 1980-05-20 | Schuster Samuel J | Receptacle for receiving articles for storage in sterilized condition |
| US4367816A (en) * | 1981-06-10 | 1983-01-11 | Wilkes Kenneth R | Tear strip for gas sterilizable package and package |
| CH657825A5 (en) * | 1982-12-01 | 1986-09-30 | Sulzer Ag | STERILIZABLE DOUBLE PACKING. |
-
1983
- 1983-11-16 US US06/552,511 patent/US4482053A/en not_active Expired - Lifetime
-
1984
- 1984-10-24 CA CA000466179A patent/CA1230860A/en not_active Expired
- 1984-11-13 JP JP59237703A patent/JPS60123372A/en active Granted
- 1984-11-14 BR BR8405822A patent/BR8405822A/en not_active IP Right Cessation
- 1984-11-15 DE DE8484307929T patent/DE3471640D1/en not_active Expired
- 1984-11-15 DK DK543784A patent/DK543784A/en not_active Application Discontinuation
- 1984-11-15 EP EP84307929A patent/EP0142378B1/en not_active Expired
- 1984-11-15 ZA ZA848922A patent/ZA848922B/en unknown
- 1984-11-15 AU AU35463/84A patent/AU564514B2/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| DK543784D0 (en) | 1984-11-15 |
| DK543784A (en) | 1985-05-17 |
| EP0142378A2 (en) | 1985-05-22 |
| JPS60123372A (en) | 1985-07-02 |
| US4482053A (en) | 1984-11-13 |
| AU564514B2 (en) | 1987-08-13 |
| EP0142378A3 (en) | 1986-08-27 |
| DE3471640D1 (en) | 1988-07-07 |
| ZA848922B (en) | 1986-06-25 |
| BR8405822A (en) | 1985-09-17 |
| JPH0468232B2 (en) | 1992-10-30 |
| AU3546384A (en) | 1985-05-23 |
| EP0142378B1 (en) | 1988-06-01 |
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