Portable drug delivery device having an encapsulated needle

• US 7,780,636 B2
• Filed: 01/05/2006
• Issued: 08/24/2010
• Est. Priority Date: 07/08/2003
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Radmer, Jim, Klint, Henrik Sonderskov
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Bouchelle; Laura A
• Application Number:
  US11/326,550
• Publication Number:
  US 20060200073A1
• Time in Patent Office: 1,692 Days
• Field of Search: 604/980.1, 604/93.01, 604/198, 604/192, 604/196, 604/180, 604/890.1, 604/171, 604/205
• US Class Current: 604/192
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

The present invention relates to medical devices which are adapted for application to a skin surface of a user and comprise a transcutaneous device which is supplied in a sterile condition. Thus, a medical device is provided, comprising a mounting surface adapted for application to the skin of a subject, a first portion having a first end adapted to penetrate the skin of the subject, and a second portion in fluid communication with the first portion and having a second end. The device further comprises enclosure means being transformable from an initial configuration encapsulating the first and second portions in an initial aseptic state, to a second configuration in which the ends of the first and second portions are allowed to communicate with the exterior through the enclosure means, wherein the enclosure means does not enclose the mounting surface.

Claims

1. A medical device, comprising:

a mounting surface adapted for application to the skin of a subject,

a transcutaneous device portion having a first end adapted to penetrate the skin of the subject, the transcutaneous device portion forming a first portion,

an inlet portion in fluid communication with the first portion and having a second end, the inlet portion forming a second portion, and

enclosure means being transformable from an initial configuration encapsulating the first and second portions in an initial sterile state, to a second configuration in which the first and second ends are allowed to communicate with the exterior through the enclosure means,

wherein the enclosure means does not enclose the mounting surface, wherein the device further comprises;

a generally U-formed hollow needle the legs thereof forming the first and second portions, wherein the U-formed hollow needle is moveable from an initial position, corresponding to the initial state and with the first needle portion retracted relative to the mounting surface, and a second position in which the second needle portion is in fluid communication with the interior of the reservoir and the pointed end of the first needle portion projects relative to the mounting surface, and

wherein the U-formed hollow needle is connected relative to the mounting surface by a hinge allowing the needle unit to pivot from the initial to the second position corresponding to a pivoting axis defined by the hinge, the pivoting axis being arranged substantially in parallel with the mounting surface.

2. A medical device, comprising:

a mounting surface adapted for application to the skin of a subject,

a transcutaneous device portion having a first end adapted to penetrate the skin of the subject, the transcutaneous device portion forming a first portion,

an inlet portion in fluid communication with the first portion and having a second end, the inlet portion forming a second portion, and

enclosure means being transformable from an initial configuration encapsulating the first and second portions in an initial sterile state, to a second configuration in which the first and second ends are allowed to communicate with the exterior through the enclosure means,

wherein the enclosure means does not enclose the mounting surface,

wherein the transcutaneous device portion comprises;

an insertion needle and a cannula disposed on and being axially moveable relative to the insertion needle,

wherein the transcutaneous device portion has a first state in which the first end is in a retracted position within the enclosure means, and a second state in which the first end projects through a portion of the enclosure means, a distal end of the insertion needle projecting from a distal opening in the cannula,

wherein the transcutaneous device portion has a third state in which the distal end of the insertion needle is retracted relative to the distal opening in the cannula.

3. A medical device, comprising:

a mounting surface adapted for application to the skin of a subject,

a transcutaneous device portion having a first end adapted to penetrate the skin of the subject, the transcutaneous device portion forming a first portion,

an inlet portion in fluid communication with the first portion and having a second end, the inlet portion forming a second portion, and

enclosure means being transformable from an initial configuration encapsulating the first and second portions in an initial sterile state, to a second configuration in which the first and second ends are allowed to communicate with the exterior through the enclosure means,

wherein the enclosure means does not enclose the mounting surface,

wherein the transcutaneous device portion comprises;

an insertion needle and a cannula disposed on and being axially moveable relative to the insertion needle wherein the insertion needle comprises a proximal end forming the inlet portion, a seal being formed between the insertion needle and the cannula providing a fluid communication between the proximal end of the insertion needle and the distal opening in the cannula.

4. A transcutaneous device unit, comprising:

a transcutaneous device portion having a first end adapted to penetrate the skin of a subject, the transcutaneous device portion forming a first portion,

an inlet portion in fluid communication with the first portion and having a second end, the inlet portion forming a second portion, and

enclosure means being transformable from an initial configuration encapsulating the first and second portions in an initial sterile state, to a second configuration in which the first and second ends are allowed to communicate with the exterior through the enclosure means,

wherein the transcutaneous device portion comprises an insertion needle and a cannula disposed on and being axially moveable relative to the insertion needle, wherein the transcutaneous device portion has a first state in which the first end is in a retracted position within the enclosure means, and a second state in which the first end projects through a portion of the enclosure means, a distal end of the insertion needle projecting from a distal opening in the cannula,

wherein the transcutaneous device portion has a third state in which the distal end of the insertion needle is retracted relative to the distal opening in the cannula, and

wherein the insertion needle is hollow and comprises a proximal end forming the inlet portion, a seal being formed between the insertion needle and the cannula providing a fluid communication between the proximal end of the insertion needle and the distal opening in the cannula.

5. A transcutaneous device unit, comprising:

a transcutaneous device portion having a first end adapted to penetrate the skin of a subject, the transcutaneous device portion forming a first portion,

an inlet portion in fluid communication with the first portion and having a second end, the inlet portion forming a second portion, and

enclosure means being transformable from an initial configuration encapsulating the first and second portions in an initial sterile state, to a second configuration in which the first and second ends are allowed to communicate with the exterior through the enclosure means,

wherein the transcutaneous device portion comprises an insertion needle and a cannula disposed on and being axially moveable relative to the insertion needle, wherein the transcutaneous device portion has a first state in which the first end is in a retracted position within the enclosure means, and a second state in which the first end projects through a portion of the enclosure means, a distal end of the insertion needle projecting from a distal opening in the cannula, and

wherein the transcutaneous device portion has a third state in which the distal end of the insertion needle is retracted relative to the distal opening in the cannula, and wherein the unit further comprising a deflecting structure, whereby a distal portion of the cannula is deflected relative to a proximal portion of the cannula as the cannula is moved from the retracted to the projecting position.