Patch-Like Infusion Device

• US 20080215015A1
• Filed: 08/12/2004
• Published: 09/04/2008
• Est. Priority Date: 08/12/2003
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Vedrine, Lionel, Sonderegger, Ralph, Harding, Weston, Cindrich, Chris, Howell, Glade, Lastovich, Alex
• Granted Patent: US 8,444,604 B2
• Time in Patent Office: Days
• US Class Current: 604/257
• CPC Class Codes: A61M 2005/14256 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16804 Flow controllers

Abstract

A system and method for a patch-like, self-contained substance infusion device (700) which provides one or more substantially hidden patient needles (760) which can be placed in fluid communication with a fluid reservoir assembly (710) that includes a rigid bladder portion (712) used in conjunction with a non-distensible bladder film (740), such as a metallized film. The device (700) can be attached to a skin surface via an adhesive contact surface and a push button (780) activation assembly can then be used to remove an interlock (730), allowing a disk, or Belleville spring (735) assembly to apply an essentially even and constant pressure to the contents of a fluid reservoir assembly (710). The push button (780) activation assembly further allows the release of one or more spring-loaded patient needles (760) into the skin surface, and establishes a fluid communication path between the patient needles (760) and the pressurized fluid reservoir contents thereby delivering an infusion into the skin. The push button (780) activation assembly further allows the release of one or more improved safety mechanisms (794) after use which are driven by spring (793) and released by trap-door (790).

Claims

1. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface adapted to contact the skin of a patient, a needle aperture on said bottom surface and a top surface;

an injection needle adapted for penetration of tissue and for movement through the needle aperture;

a reservoir, disposed within said housing, said reservoir in fluid communication to the injection needle;

a pressurization system for pressurizing the reservoir;

a shielding member adapted for movement away from the bottom surface, the shielding member having a covering portion disposed about the needle aperture, and at least one stanchion protruding from the covering portion, the shielding member having a first position wherein the stanchion of the shielding member is initially disposed within the housing and the covering portion is substantially co-planar with the bottom surface of the housing, and a second position wherein the stanchion of the shielding member is partially withdrawn from the housing and the covering portion at least partially covers the needle;

a biasing element disposed within the housing adapted to contact the shielding member and bias the shielding member towards the second position of the shielding member; and

a movable interposer having a first position, which prevents movement of the shielding member, and a second position, which allows movement of the shielding member;

wherein when the device is placed upon the skin of the patient and activated, the interposer is moved from a first position to a second position and the biasing element is allowed to bias the shielding member into the second position, thereby, as the device is removed from the skin, the shielding member emerges from the housing and at least partially covers the needle.

2. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface adapted to contact the skin of a patient, a needle aperture on said bottom surface and a top surface;

an injection needle adapted for penetration of tissue and for movement through the needle aperture;

a reservoir, disposed within said housing, said reservoir in fluid communication to the injection needle;

a pressurization system for pressurizing the reservoir; and

a shielding member adapted for movement substantially perpendicular to the bottom surface, the shielding member having a skin contacting portion disposed about the needle aperture and is substantially covered with adhesive, and at least one stanchion protruding from the skin contacting portion, the shielding member having a first position wherein the stanchion of the shielding member is initially disposed within the housing and the skin contacting portion is substantially co-planar with the bottom surface of the housing, and a second position wherein the stanchion of the shielding member is partially withdrawn from the housing and the shielding member at least partially covers the needle;

wherein when the device is placed upon the skin of the patient, the skin contacting portion of the shielding member is temporarily adhered to the skin and when the device is removed from the skin, the adhesion of the shielding member to the skin is sufficient to move the shielding member from the first position to the second position.

3. A device for delivering a medicament into the body of a patient by injection into or through the skin of a patient, comprising:

a housing having a bottom surface, a needle aperture on said bottom surface and a top surface;

an injection needle adapted for penetration of tissue and for movement through the needle aperture;

a reservoir, disposed within said housing, said reservoir in fluid communication to the injection needle;

a pressurization system for pressurizing the reservoir; and

a shielding member adapted for rotational movement along an arcuate path substantially perpendicular to the bottom surface, the shielding member having a skin contacting portion disposed about the needle aperture and is substantially covered with adhesive, and a pivot, the shielding member having a first position wherein shielding member is substantially co-planar with the bottom surface of the housing, and a second position wherein the shielding member is rotated about the pivot and the shielding member at least partially covers the needle;

wherein when the device is placed upon the skin of the patient, the skin contacting portion of the shielding member is temporarily adhered to the skin and when the device is removed from the skin, the adhesion of the shielding member to the skin is sufficient to rotate the shielding member about the pivot from the first position to the second position.