US5765682A — Restrictive package for expandable or shape memor…

Claim 1

Independent Claim 124 words

An assembly including a medical device and a package therefor, wherein said medical device is one of a catheter and a stent device, the medical device being shaped to have a continuous passage therethrough and made of a shape memory material or an expanding material which changes shape or expands, respectively, when exposed to a predetermined condition, said predetermined condition comprising exposure to an elevated temperature or a liquid, wherein said package comprises a sheath disposed around said medical device, said sheath comprising material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, wherein said sheath is removed before said medical device is placed in a body cavity.

Claim 2

Dependent Claim 124 words

An assembly including a medical device and a package therefor, wherein said medical device is one of a catheter and a stent device, the medical device being shaped to have a continuous passage therethrough and made of a shape memory material or an expanding material which changes shape or expands, respectively, when exposed to a predetermined condition, said predetermined condition comprising exposure to an elevated temperature or a liquid, wherein said package comprises a sheath disposed around said medical device, said sheath comprising material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, wherein said sheath is removed before said medical device is placed in a body cavity.

Claim 3

Dependent Claim 42 words

The assembly of claim 1 wherein said sheath further comprises a line of weakened material disposed along its length whereby upon applying a force to said line of weakened material, said sheath is opened to expose said medical device for access thereto.

Claim 4

Dependent Claim 38 words

The assembly of claim 1 wherein said sheath further comprises a string embedded therein along the length of said sheath, whereby pulling said string causes a rupture in the sheath to expose said medical device for access thereto.

Claim 5

Dependent Claim 24 words

The assembly of claim 1 wherein said sheath further comprises a hole along its length with a patch covering said hole removably adhered thereto.

Claim 6

Dependent Claim 14 words

The assembly of claim 1 wherein said sheath is tightly constricting said medical device.

Claim 7

Dependent Claim 15 words

The assembly of claim 1 wherein said sheath surrounds said medical device with some clearance.

Claim 8

Dependent Claim 36 words

The assembly of claim 1 wherein said medical device comprises an irregularly shaped portion, and said sheath further comprises a window aligned with said irregularly shaped portion, wherebe said irregularly shaped portion extends through said window.

Claim 9

Dependent Claim 29 words

The assembly of claim 1 wherein said sheath is made of a material which has a deflection temperature of above about 65° C. at 264 pounds per square inch.

Claim 10

Dependent Claim 39 words

The assembly of claim 1 wherein said sheath is made of a material selected from the group consisting of polyvinyl chloride, polyesters, polypropylene, polyamide, aliphatic polyesters, high density polyethylene, ethylene copolymers, polyurethane, acrylonitrile butadiene styrene, ABS, nylon, and fluoropolymers.

Claim 11

Dependent Claim 12 words

The assembly of claim 1 wherein said material is a dissolvable material.

Claim 12

Dependent Claim 26 words

The assembly of claim 10 wherein said dissolvable material is a hydrophilic material selected from the group consisting of polyethethylene oxide, polyvinyl pyrrolidone and polyvinyl alcohol.

Claim 13

Dependent Claim 114 words

A package for a metallic medical device, said medical device being made of a shape memory material or an expanding material which changes shape or expands respectively when exposed to a predetermined condition, said predetermined condition comprising exposure to an elevated temperature, said package comprising a sheath enclosing the medical device, said sheath comprising a material that prevents expansion or a change in shape of the medical device upon exposure of said medical device and sheath assembly to said predetermined condition, said sheath further comprising a tear-away means of opening for providing access to said medical device disposed therein, wherein said sheath is removed before said medical device is placed in a body cavity.

Claim 14

Dependent Claim 114 words

A package for a metallic medical device, said medical device being made of a shape memory material or an expanding material which changes shape or expands respectively when exposed to a predetermined condition, said predetermined condition comprising exposure to an elevated temperature, said package comprising a sheath enclosing the medical device, said sheath comprising a material that prevents expansion or a change in shape of the medical device upon exposure of said medical device and sheath assembly to said predetermined condition, said sheath further comprising a tear-away means of opening for providing access to said medical device disposed therein, wherein said sheath is removed before said medical device is placed in a body cavity.

Claim 15

Dependent Claim 42 words

The package of claim 12 wherein said sheath further comprises a line of weakened material disposed along its length whereby upon applying a force to said line of weakened material, said sheath is opened to expose said medical device for access thereto.

Claim 16

Dependent Claim 38 words

The package of claim 12 wherein said sheath further comprises a string embedded therein along the length of said sheath, whereby pulling said string causes a rupture in the sheath to expose said medical device for access thereto.

Claim 17

Dependent Claim 24 words

The package of claim 12 wherein said sheath further comprises a hole along its length with a patch covering said hole removably adhered thereto.

Claim 18

Dependent Claim 14 words

The package of claim 12 wherein said sheath is tightly constricting said medical device.

Claim 19

Dependent Claim 29 words

The package of claim 12 wherein said sheath is made of a material which has a deflection temperature of above about 65° C. at 264 pounds per square inch.

Claim 20

Dependent Claim 156 words

An assembly including a medical device and a package therefor, wherein said medical device is a communicative device and is made of a shape memory material or an expanding material which changes shape or expands respectively when exposed to a predetermined condition, wherein said medical device has a first configuration having a first length and a first dimension and a second configuration having a second length and a second dimension, said second length being longer than said first length, said second diameter, being smaller than said first diameter, wherein said package comprises a sheath disposed around said medical device, said sheath comprising a material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, wherein said sheath holds said medical device in said second configuration, and wherein said sheath is removed before said medical device is placed in a body cavity.

Claim 21

Dependent Claim 156 words

An assembly including a medical device and a package therefor, wherein said medical device is a communicative device and is made of a shape memory material or an expanding material which changes shape or expands respectively when exposed to a predetermined condition, wherein said medical device has a first configuration having a first length and a first dimension and a second configuration having a second length and a second dimension, said second length being longer than said first length, said second diameter, being smaller than said first diameter, wherein said package comprises a sheath disposed around said medical device, said sheath comprising a material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, wherein said sheath holds said medical device in said second configuration, and wherein said sheath is removed before said medical device is placed in a body cavity.

Claim 22

Dependent Claim 42 words

The assembly of claim 18 wherein said sheath further comprises a line of weakened material disposed along its length whereby upon applying a force to said line of weakened material, said sheath is opened to expose said medical device for access thereto.

Claim 23

Dependent Claim 14 words

The assembly of claim 18 wherein said sheath is tightly constricting said medical device.

Claim 24

Dependent Claim 15 words

The assembly of claim 18 wherein said sheath surrounds said medical device with some clearance.

Claim 25

Dependent Claim 29 words

The assembly of claim 18 wherein said sheath is made of a material which has a deflection temperature of above about 65° C. at 264 pounds per square inch.

Claim 26

Dependent Claim 39 words

The assembly of claim 18 wherein said sheath is made of a material selected from the group consisting of polyvinyl chloride, polyesters, polypropylene, polyamide, aliphatic polyesters, high density polyethylene, ethylene copolymers, polyurethane, acrylonitrile butadiene styrene, ABS, nylon, and fluoropolymers.

Claim 27

Dependent Claim 166 words

A package for a medical device, said medical device is a communicative device being made of a shape memory material or an expanding material which changes shape or expands, respectively, when exposed to a predetermined condition, wherein said medical device has a first configuration having a first length and a first dimension and a second configuration having a second length and a second dimension, said second length being longer than said first length, said second dimension being smaller than said first dimension, said package comprising a sheath enclosing said medical device, said sheath comprising a material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, said sheath further comprising a tear-away means of opening for providing access to said medical device disposed therein, wherein said sheath holds said medical device in said second configuration and wherein said sheath is removed before said medical device is placed in a body cavity.

Claim 28

Dependent Claim 166 words

A package for a medical device, said medical device is a communicative device being made of a shape memory material or an expanding material which changes shape or expands, respectively, when exposed to a predetermined condition, wherein said medical device has a first configuration having a first length and a first dimension and a second configuration having a second length and a second dimension, said second length being longer than said first length, said second dimension being smaller than said first dimension, said package comprising a sheath enclosing said medical device, said sheath comprising a material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, said sheath further comprising a tear-away means of opening for providing access to said medical device disposed therein, wherein said sheath holds said medical device in said second configuration and wherein said sheath is removed before said medical device is placed in a body cavity.

Claim 29

Dependent Claim 42 words

The package of claim 24 wherein said sheath further comprises a line of weakened material disposed along its length whereby upon applying a force to said line of weakened material, said sheath is opened to expose said medical device for access thereto.

Claim 30

Dependent Claim 14 words

The package of claim 24 wherein said sheath is tightly constricting said medical device.

Claim 31

Dependent Claim 29 words

The package of claim 24 wherein said sheath is made of a material which has a deflection temperature of above about 65° C. at 264 pounds per square inch.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2001-06-15	2001-12-15	2002-06-16	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2005-06-15	2005-12-15	2006-06-16	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2009-06-15	2009-12-15	2010-06-16	$7700.00	Window Closed / Lapsed

Restrictive package for expandable or shape memory medical devices and method of preventing premature change of same

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