Medical device package

Patent metadata

Field	Value
Publication number	US-9623171-B2
Application number	US-201414464195-A
Country	US
Kind code	B2
Filing date	Aug 20, 2014
Priority date	Feb 20, 2012
Publication date	Apr 18, 2017
Grant date	Apr 18, 2017

Abstract

A medical device package includes a medical device including a first end surface and a second end surface; and a medical device storage container configured to store the medical device, the medical device storage container including a container main body and a holding unit located in the storage space, and configured to hold the medical device such that the first end surface faces upward; and a sheet-like sealing member adapted to be glued to the container main body to seal an opening of the container main body. A surface of the sealing member that faces the container main body includes an adhesive applied area on which an adhesive is applied and an adhesive non-applied area on which the adhesive is not applied, the adhesive non-applied area being an area facing at least the first end surface of the medical device held by the holding unit.

First claim

What is claimed is:

1. A medical device package comprising:
a medical device including a first end surface and a second end surface; and
a medical device storage container storing the medical device, the medical device storage container comprising:
a container main body including a peripheral wall portion having an upper end portion and a lower end portion, a bottom that is continuous with the lower end portion and surrounded by the lower end portion, an opening surrounded by the upper end portion, and a storage space formed inside the peripheral wall portion and the bottom, and
a holding unit located in the storage space, and holding the medical device such that the first end surface faces upward; and
a sealing member comprising a nonwoven fabric sheet that is permeable to gas and/or vapor but impermeable to minute particles, the nonwoven fabric sheet having a lower surface that faces the container main body,

wherein the sealing member is glued to the container main body via a heat-melted adhesive to seal the opening of the container main body,
wherein the lower surface of the nonwoven fabric sheet includes an adhesive applied area on which the adhesive is applied and an adhesive non-applied area on which the adhesive is not applied, the nonwoven fabric sheet being configured such that the adhesive non-applied area faces at least the first end surface of the medical device held by the holding unit,
wherein the adhesive non-applied area is formed without bonding another sheet on the nonwoven fabric sheet, and
wherein the sealing member is deformed such that a central portion of the sealing member protrudes toward the bottom of the container main body and such that the adhesive non-applied area of the nonwoven fabric sheet contacts the first end surface of the medical device but does not contact any portion of the bottom of the container main body.

2. The medical device package according to claim 1 , wherein:
the medical device is a syringe that includes a filling opening configured to allow a drug solution to be filled in the first end surface, and
the holding unit comprises a syringe holding member that is engaged with an inner surface of the peripheral wall portion and adapted to hold the syringe such that the first end surface of the syringe faces upward.

3. The medical device package according to claim 2 , further comprising an inner sheet adapted to cover a side of the first end surface of the syringe held by the syringe holding member,
wherein the adhesive non-applied area of the nonwoven fabric sheet contacts the first end surface of the syringe via the inner sheet.

4. The medical device package according to claim 3 , wherein the adhesive non-applied area includes at least an area facing the inner sheet.

5. The medical device package according to claim 2 , wherein the syringe includes a discharge portion forming the second end surface and configured to discharge the drug solution.

6. The medical device package according to claim 1 , wherein the adhesive non-applied area includes at least an area facing the opening.

7. The medical device package according to claim 1 , wherein:
the container main body includes a flange portion that is continuous with the upper end portion and surrounds the upper end portion, and
the sealing member is glued to the flange portion.

8. The medical device package according to claim 7 , wherein the central portion of the sealing member is located lower than a portion of the sealing member adjacent to the flange.

9. The medical device package according to claim 1 , wherein:
the sealing member is permeable by a high-pressure vapor, and
the medical device stored in the container main body is a medical device that has been sterilized via a high-pressure vapor that permeates the sealing member.

10. A method of manufacturing a medical device package,
providing a medical device including a first end surface and a second end surface; and
providing a medical device storage container comprising:
a container main body including a peripheral wall portion having an upper end portion and a lower end portion, a bottom that is continuous with the lower end portion and surrounded by the lower end portion, an opening surrounded by the upper end portion, and a storage space formed inside the peripheral wall portion and the bottom, and
a holding unit located in the storage space; and
a sealing member comprising a nonwoven fabric sheet that is permeable to gas and/or vapor but impermeable to minute particles, the nonwoven fabric sheet having a lower surface that faces the container main body;

placing the medical device in the holding unit of the storage container such that the first end surface faces upward;
gluing the sealing member is to the container main body via a heat-melted adhesive to seal the opening of the container main body, such that the lower surface of the nonwoven fabric sheet includes an adhesive applied area on which the adhesive is applied and an adhesive non-applied area on which the adhesive is not applied, and such that the adhesive non-applied area faces at least the first end surface of the medical device held by the holding unit, wherein the adhesive non-applied area is formed without bonding another sheet on the nonwoven fabric sheet; and
sterilizing the package assembly by a high-temperature vapor or gas, so as to deform the sealing member with the high-temperature vapor or gas such that a central portion of the sealing member protrudes toward the bottom of the container main body and such that the adhesive non-applied area of the nonwoven fabric sheet contacts the first end surface of the medical device but does not contact any portion of the bottom of the container main body.

11. A medical device package comprising:
a medical device including a first end surface and a second end surface; and
a medical device storage container storing the medical device, the medical device storage container comprising:
a container main body including a peripheral wall portion having an upper end portion and a lower end portion, a bottom that is continuous with the lower end portion and surrounded by the lower end portion, an opening surrounded by the upper end portion, and a storage space formed inside the peripheral wall portion and the bottom, and
a holding unit located in the storage space, and holding the medical device such that the first end surface faces upward; and
a nonwoven fabric sheet being permeable to gas and/or vapor but impermeable to minute particles, and having a lower surface that faces the container main body,

wherein the nonwoven fabric sheet is glued to the container main body via a heat-melted adhesive to seal the opening of the container main body,
wherein the lower surface of the nonwoven fabric sheet includes an adhesive applied area on which the adhesive is applied and an adhesive non-applied area on which the adhesive is not applied, the nonwoven fabric sheet being configured such that the adhesive non-applied area faces at least the first end surface of the medical device held by the holding unit,
wherein the adhesive non-applied area is formed without bonding another sheet on the nonwoven fabric sheet,
wherein the nonwoven fabric sheet is deformed such that a central portion of the nonwoven fabric sheet protrudes toward the bottom of the container main body and such that the adhesive non-applied area of the nonwoven fabric sheet contacts the first end surface of the medical device but does not contact any portion of the bottom of the container main body.

12. The medical device package according to claim 11 , wherein the medical device storage container does not include an inner sheet

Assignees

• Terumo Corp

Inventors

• Okihara Hitoshi
• Koyama Shingo
• Nakamura Koji

Classifications

• B65D25/108

  Devices, e.g. plates, presenting apertures through which the articles project · CPC title

• B65D77/2024

  the cover being welded or adhered to the container · CPC title

• A61M5/001

  Apparatus specially adapted for cleaning or sterilising syringes or needles · CPC title

• A61M5/002 Primary

  Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics (needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001) · CPC title

• B65B55/18

  by liquids or gases (B65B55/14 takes precedence) · CPC title