Medical device package, kit and associated methods

• US 20050061700A1
• Filed: 09/19/2003
• Published: 03/24/2005
• Est. Priority Date: 09/19/2003
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson), LifeScan IP Holdings, LLC
• Original Assignee: Diabetes Diagnostics, Inc. (Johnson & Johnson)
• Inventors: Windus-Smith, Bryan, Allen, John
• Granted Patent: US 7,617,932 B2
• Time in Patent Office: Days
• US Class Current: 206/438
• CPC Class Codes: A61B 17/3215 Packages or dispensers for scalpel blades for sharps A61B50/3001
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150923 by means for destroying components or parts, e.g. by cutting or piercing
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 50/3001 for sharps
• CPC Class Codes: A61B 50/362 for sharps

Abstract

A medical device package for receiving, and securely and removably retaining, a medical device includes main and minor cap members. The main cap member has a proximal end, a distal end and a cavity with a cavity opening at the proximal end. The cavity is configured to receive, and to securely and removably retain, the medical device at least partially therein. The minor cap member is configured to seal the cavity opening once the medical device has been received in the cavity. Kits further include a connector adapted for engaging the medical device member and breaching the minor cap member. A method for extracting a medical device from a medical device package includes first providing a medical device package as described above, with a medical device therein, and a connector. The method also includes breaching the minor cap member with the connector such that at least a portion of the connector enters the cavity of the medical device package. Next, the medical device is engaged by the connector and extracted from the medical device package.

Claims

1. A medical device package comprising:

a main cap member with a cavity therein, the main cap member including;

a proximal end; and

a distal end; and

a minor cap member,

wherein;

the cavity has a cavity opening at the proximal end of the main cap member;

the cavity is configured to receive, and to securely and removably retain, a medical device at least partially therein, and

the minor cap member is configured to seal the cavity opening once the medical device has been received in the cavity.

2. The medical device package of claim 1, wherein the main cap member includes at least one lateral channel and wherein the medical device is securely and removably retained by a friction fit between the medical device and the at least one lateral channel.

3. The medical device package of claim 1, wherein the main cap member includes a directional marker.

4. The medical device package of claim 1, wherein the main cap member cavity is configured to receive, and to securely and removably retain, an integrated medical device that includes electrical contacts such that the electrical contacts project from the cavity opening and minor cap member.

5. The medical device package of claim 1, wherein the minor cap member includes ribs that seal the cavity opening.

6. The medical device package of claim 1, wherein the minor cap member is a breachable minor cap member.

7. The medical device package of claim 1, wherein the minor cap member is configured for permanent attachment to the medical device.

8. The medical device package of claim 1, wherein the main cap member further includes a distal end cavity configured for disabling the medical device.

9. A medical device package kit comprising:

a main cap member with a cavity therein, the main cap member including;

a proximal end; and

a distal end;

a minor cap member; and

a connector,

wherein;

the cavity has a cavity opening at the proximal end of the main cap member;

the cavity is configured to receive, and to securely and removably retain, a medical device at least partially therein;

the minor cap member is configured to seal the cavity opening once the medical device has been received in the cavity; and

the connector is configured to engage the medical device during removal of the medical device from the cavity.

10. The medical device package kit of claim 9, wherein the connector includes a connector directional marker.

11. The medical device package kit of claim 9, wherein the connector is further configured to breach the minor cap member.

12. The medical device package kit of claim 9, wherein the connector includes at least one strip engaging element for contacting electrical contacts of the medical device.

13. A method for extracting a medical device from a medical device package, the method comprising:

providing;

a medical device package with a medical device contained therein, the medical device package including;

a main cap member with a cavity therein, the main cap member including;

a proximal end; and

a distal end;

a minor cap member; and

wherein;

the cavity has a cavity opening at the proximal end of the main cap member;

the cavity is configured to receive, and to securely and removably retain, a medical device at least partially therein; and

the minor cap member is sealing the cavity opening; and

a connector;

breaching the minor cap member with the connector such that at least a portion of the connector has entered the cavity of the medical device cavity;

engaging the medical device with the connector; and

extracting the connector and engaged medical device from the cavity of the medical device package.

14. The method of claim 13, wherein the medical device is an integrated medical device that includes a tissue penetration member and a test strip.

15. A method for extracting a medical device from a medical device package and subsequently disabling the medical device, the method comprising:

providing;

a medical device package with a medical device contained therein at a first position, the medical device package including;

a main cap member with a cavity therein, the main cap member including;

a proximal end; and

a distal end;

a minor cap member; and

wherein;

the cavity has a cavity opening at the proximal end of the main cap member;

the cavity is configured to receive, and to securely and removably retain, a medical device at least partially therein;

the minor cap member is sealing the cavity opening; and

a connector;

breaching the minor cap member with the connector such that at least a portion of the connector has entered the cavity of the medical device cavity;

engaging the medical device with the connector;

extracting the connector and engaged medical device from the cavity of the medical device package; and

subsequently inserting the connector and engaged medical device into a cavity of the medical device package to a second position whereby the medical device is disabled from subsequent use.

16. The method of claim 15, wherein the inserting step includes inserting the engaged medical device into the cavity of the main cap member.

17. The method of claim 16, wherein the inserting step includes inserting the engaged medical device into a distal end cavity of the medical device package.

18. The method of claim 16 further including:

disengaging the connector from the disabled medical device; and

withdrawing the connector from the medical device package.