US5322161A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Clear package for bioabsorbable articles
Assignee: United States Surgical Corp
•
Filing: 1992-11-30
•
Granted: 1994-06-21
•
Expires: 2012-11-30
Abstract
Abstract A flexible package of low moisture permeability suitable for packaging moisture sensitive materials and devices such as bioabsorbable surgical staples and clips and instruments containing these devices includes a first panel fabricated from a substantially transparent polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, the first panel having a measurable moisture vapor transmission rate and being bonded along its edges to the edges of a second panel fabricated from either (i) a transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel; or (ii) an opaque, flexible metal foil laminate to form a contents-enclosing pouch therebetween, the pouch containing a quantity of desiccant and at least one sterile moisture-sensitive material or device, e.g., the aforesaid bioabsorbable staples, clips or instruments containing such staples or clips.
Inventors
- 👤 Daniel Shichman
- 👤 David L. Brown
- 👤 Stanley J. Malinowski
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 11:48
CPC Classifications
A; A61; A61L; A61L2/00; A61L2/16; A61L2/20; A61L2/206; B; B32; B32B; B32B15/00; B32B15/04; B32B15/08; B32B15/088; A61B; A61B50/00; A61B50/30; B32B15/082; B32B27/00; B32B27/06; B32B27/32; B32B27/34; B65; B65D; B65D81/00; B65D81/24; B65D81/26; B65D81/266; A61B17/00; A61B17/064; A61B17/068; A61B17/08; A61B17/083; A61B2017/00004; A61B2017/0688; A61B2050/005; A61B2050/0065; A61B2050/3004; A61B2050/3015; A61B50/33; B32B2307/00; B32B2307/70; B32B2307/724; B32B2307/7242; B32B2307/7246; B32B2311/00; B32B2311/24; B32B2323/00; B32B2323/04; B32B2323/046; B32B2379/00; B32B2379/08; B32B2439/00; B32B2439/80
Claims Analysis
Total Claims: 46
Claim 1
Independent Claim
178 words
A flexible package which comprises a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, said first panel having a measurable moisture vapor transmission rate, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-enclosing pouch therebetween, the pouch containing a quantity of desiccant and at least one sterile moisture-sensitive device or material, the desiccant being provided as at least one discrete desiccant unit loosely contained within the pouch or in a fixed location therein, the desiccant unit itself comprising a pouch made from a material having a moisture vapor transmission rate of about 1 g/100 in 2 /24 hrs with the desiccant contained within a pouch of the desiccant unit.
Claim 2
Dependent Claim
178 words
A flexible package which comprises a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, said first panel having a measurable moisture vapor transmission rate, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-enclosing pouch therebetween, the pouch containing a quantity of desiccant and at least one sterile moisture-sensitive device or material, the desiccant being provided as at least one discrete desiccant unit loosely contained within the pouch or in a fixed location therein, the desiccant unit itself comprising a pouch made from a material having a moisture vapor transmission rate of about 1 g/100 in 2 /24 hrs with the desiccant contained within a pouch of the desiccant unit.
Claim 3
Dependent Claim
43 words
The package of claim 1 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halopolymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin.
Claim 4
Dependent Claim
22 words
The package of claim 1 wherein at least said first panel transparent polymeric laminate film includes a layer formed from polyethylene terephthalate.
Claim 5
Dependent Claim
33 words
The package of claim 1 wherein the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide.
Claim 6
Dependent Claim
29 words
The package of claim 1 wherein the inorganic moisture vapor transmission barrier layer is formed from at least one oxide of silicon, aluminum and zirconium containing a metal dopant.
Claim 7
Dependent Claim
16 words
The package of claim 1 wherein the second panel is fabricated from an aluminum foil laminate.
Claim 8
Dependent Claim
32 words
The package of claim 1 wherein the second panel is fabricated from an aluminum foil laminate possessing a low density polyethylene layer on one side and a polyamide layer on the other.
Claim 9
Dependent Claim
29 words
The package of claim 1 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.1 g/100 in 2 /24 hrs.
Claim 10
Dependent Claim
29 words
The package of claim 1 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.05 g/100 in 2 /24 hrs.
Claim 11
Dependent Claim
29 words
The package of claim 1, wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.025 g/100 in 2 /24 hrs.
Claim 12
Dependent Claim
24 words
The package of claim 1 wherein the desiccant is at least one material selected from the group consisting of silica gel and molecular sieve.
Claim 13
Dependent Claim
30 words
The package of claim 1 wherein the desiccant includes a material which indicates by change of color when the capacity of the desiccant for absorbing moisture has been effectively exhausted.
Claim 14
Dependent Claim
101 words
The package of claim 1, wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate and the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve.
Claim 15
Dependent Claim
32 words
The package of claim 1 wherein the first panel is bonded to the second panel through a heat sealable coating composition applied to one or both mutually contacting surfaces of the panels.
Claim 16
Dependent Claim
15 words
The package of claim 1, wherein the first panel is peelable from the second panel.
Claim 17
Dependent Claim
18 words
The package of claim 1 wherein the moisture sensitive device is a bioabsorbable hemostatic or wound closure device.
Claim 18
Dependent Claim
16 words
The package of claim 1 wherein the moisture sensitive device is a bioabsorbable clip or staple.
Claim 19
Dependent Claim
26 words
The package of claim 1 wherein the moisture sensitive device is a bioabsorbable clip or staple stored within an apparatus for applying the clip or staple.
Claim 20
Dependent Claim
112 words
The package of claim 1 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.
Claim 21
Dependent Claim
164 words
A flexible package which comprises a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, said first panel having a measurable moisture vapor transmission rate, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-enclosing pouch therebetween, the pouch containing a quantity of desiccant and at least one sterile moisture-sensitive device or material, and a removable header at least partially fabricated from a gas permeable sheet material which is a barrier to microorganisms, one end of the header being attached to the opening of the package and the other end of the header being open or sealed.
Claim 22
Dependent Claim
164 words
A flexible package which comprises a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, said first panel having a measurable moisture vapor transmission rate, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-enclosing pouch therebetween, the pouch containing a quantity of desiccant and at least one sterile moisture-sensitive device or material, and a removable header at least partially fabricated from a gas permeable sheet material which is a barrier to microorganisms, one end of the header being attached to the opening of the package and the other end of the header being open or sealed.
Claim 23
Dependent Claim
17 words
The package of claim 20 wherein the gas permeable sheet of the header is a spunbonded polyethylene.
Claim 24
Dependent Claim
22 words
The package of claim 20 from which the header has been removed with the exception of a residual strip of header material.
Claim 25
Dependent Claim
112 words
The package of claim 20 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.
Claim 26
Independent Claim
196 words
A method of packaging a moisture-sensitive device or material which comprises: a) providing an open flexible package comprising a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-receiving open pouch therebetween; b) placing at least one moisture-sensitive device or material and a quantity of desiccant within the pouch, the desiccant being provided as at least one discrete desiccant unit loosely contained within the pouch or in a fixed location therein, the desiccant unit itself comprising a pouch made from a material having a moisture vapor transmission rate of about 1 g/100 /in 2 /24 hrs with the desiccant contained within a pouch of the desiccant unit; c) sealing the pouch; and, d) sterilizing the contents of the package.
Claim 27
Independent Claim
196 words
A method of packaging a moisture-sensitive device or material which comprises: a) providing an open flexible package comprising a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-receiving open pouch therebetween; b) placing at least one moisture-sensitive device or material and a quantity of desiccant within the pouch, the desiccant being provided as at least one discrete desiccant unit loosely contained within the pouch or in a fixed location therein, the desiccant unit itself comprising a pouch made from a material having a moisture vapor transmission rate of about 1 g/100 /in 2 /24 hrs with the desiccant contained within a pouch of the desiccant unit; c) sealing the pouch; and, d) sterilizing the contents of the package.
Claim 28
Dependent Claim
42 words
The method of claim 24 wherein at least said first transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halopolymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin.
Claim 29
Dependent Claim
21 words
The method of claim 24 wherein at least said first transparent polymeric laminate film includes a layer formed from polyethylene terephthalate.
Claim 30
Dependent Claim
33 words
The method of claim 24 wherein the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide.
Claim 31
Dependent Claim
29 words
The method of claim 24 wherein the inorganic moisture vapor transmission barrier layer is formed from at least one oxide of silicon, aluminum and zirconium containing a metal dopant.
Claim 32
Dependent Claim
16 words
The method of claim 24 wherein the second panel is fabricated from an aluminum foil laminate.
Claim 33
Dependent Claim
32 words
The method of claim 24 wherein the second panel is fabricated from an aluminum foil laminate possessing a low density polyethylene layer on one side and a polyamide layer on the other.
Claim 34
Dependent Claim
29 words
The method of claim 24 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.1 g/100 in 2 /24 hrs.
Claim 35
Dependent Claim
29 words
The method of claim 24 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.05 g/100 in 2 /24 hrs.
Claim 36
Dependent Claim
29 words
The method of claim 24 wherein the moisture vapor transmission rate of the inorganic moisture vapor transmission barrier layer does not exceed about 0.025 g/100 in 2 /24 hrs.
Claim 37
Dependent Claim
24 words
The method of claim 24 wherein the desiccant is at least one material selected from the group consisting of silica gel and molecular sieve.
Claim 38
Dependent Claim
30 words
The method of claim 24 wherein the desiccant includes a material which indicated by change of color when the capacity of the desiccant for absorbing moisture has been effectively exhausted.
Claim 39
Dependent Claim
112 words
The method of claim 24 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.
Claim 40
Dependent Claim
32 words
The method of claim 24 wherein the first panel is bonded to the second panel through a heat sealable coating composition applied to one or both mutually containing surfaces of the panels.
Claim 41
Dependent Claim
15 words
The method of claim 24 wherein the first panel is peelable from the second panel.
Claim 42
Dependent Claim
112 words
The method of claim 24 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.
Claim 43
Independent Claim
224 words
A method of packaging a moisture-sensitive device or material which comprises: a) providing an open flexible package comprising a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) a substantially transparent flexible polymeric film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-receiving open pouch therebetween, and a header at least partially fabricated from a gas permeable sheet material which is a barrier to microorganisms, one end of the header being attached to the opening of the package and the other end of the header being open; b) placing at least one moisture-sensitive device or material and a quantity of desiccant within the open pouch; c) sealing the open end of the header; d) introducing a sterilizing gas into the pouch through the gas permeable sheet of the header to sterilize the contents of the package; e) removing the sterilizing gas from the pouch following sterilization of its contents; f) sealing the package; and, g) removing at least part of the header.
Claim 44
Independent Claim
224 words
A method of packaging a moisture-sensitive device or material which comprises: a) providing an open flexible package comprising a first panel fabricated from a substantially transparent flexible polymeric laminate film possessing an inorganic moisture vapor transmission barrier layer, the first panel being bonded along its edges to the edges of a second panel fabricated from a material selected from the group consisting of (i) a substantially transparent flexible polymeric film possessing an inorganic moisture vapor transmission barrier layer which is the same as, or is different from, the film of the first panel and (ii) an opaque, flexible metal foil laminate, to form a contents-receiving open pouch therebetween, and a header at least partially fabricated from a gas permeable sheet material which is a barrier to microorganisms, one end of the header being attached to the opening of the package and the other end of the header being open; b) placing at least one moisture-sensitive device or material and a quantity of desiccant within the open pouch; c) sealing the open end of the header; d) introducing a sterilizing gas into the pouch through the gas permeable sheet of the header to sterilize the contents of the package; e) removing the sterilizing gas from the pouch following sterilization of its contents; f) sealing the package; and, g) removing at least part of the header.
Claim 45
Dependent Claim
17 words
The method of claim 40 wherein the gas permeable sheet of the header is a spunbonded polyethylene.
Claim 46
Dependent Claim
112 words
The method of claim 40 wherein at least said first panel transparent polymeric laminate film includes a layer formed from a polymer selected from the group consisting of polyester, polyamide, polyolefin, halogenated polymer, polyimide, polycarbonate, polyurethane, polystyrene, hydrolyzed ethylene-vinyl acetate copolymer and cellulosic resin, the inorganic moisture vapor transmission barrier layer is formed from at least one oxide selected from the group consisting of silicon oxide, aluminum oxide and zirconium oxide, the metal foil laminate is an aluminum foil laminate, the desiccant unit contains at least one desiccant material selected from the group consisting of silica gel and molecular sieve and the moisture-sensitive device is a bioabsorbable hemostatic or wound closure device.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-06-20 | 1997-12-20 | 1998-06-21 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-06-20 | 2001-12-20 | 2002-06-21 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-06-20 | 2005-12-20 | 2006-06-21 | $7700.00 | Window Closed / Lapsed |