Medical Device with Protected Transcutaneous Device

• US 20090076451A1
• Filed: 01/24/2006
• Published: 03/19/2009
• Est. Priority Date: 01/24/2005
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Teisen-Simony, Claude, Rorvig, Simon
• Application Number:
  US11/813,433
• Publication Number:
  US 20090076451A1
• Time in Patent Office: Days
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A medical device is provided comprising a first a second units, the first unit comprising a housing with a skin-mountable surface, and a transcutaneous device having a distal portion adapted to be arranged through the skin of the subject in a situation of use in which the housing has been applied on a skin surface. The second unit is adapted to be releasably coupled to the first unit thereby, in a situation of use, substantially covering an introduction site of the transcutaneous device through the skin, whereby at least partial removal of the second unit from the first unit at least partially uncovers the introduction site. In this way the transcutaneous device can be protected during use, yet it allows the user to inspect the introduction site.

Claims

1. A medical device comprising a first unit (1010) and a second unit (1050), the first unit being a transcutaneous device unit comprising:

a housing (1015) comprising a mounting surface (1020) adapted for application towards a skin surface of a subject, and

a transcutaneous device (1017) having a distal portion adapted to be arranged through the skin of the subject in a situation of use in which the housing has been applied towards a skin surface of the subject,

the second unit being adapted to be releasably coupled to the first unit thereby, in a situation of use, substantially covering an introduction site of the transcutaneous device through the skin,

wherein at least partial removal of the second unit from the first unit at least partially uncovers the introduction site.

2. A medical device as in claim 1, wherein the distal portion is adapted to be arranged through the skin of the subject at an inclined angle relative to the mounting surface.

3. A medical device as in claim 1, wherein the distal portion is inclined towards the second unit when the first and second units are coupled to each other.

4. A medical device as in claim 1, wherein the transcutaneous device has a retracted position relative to the mounting surface, and an extended position in which the distal portion projects relative to the mounting surface.

5. A medical device as in claim 4, wherein the transcutaneous device unit comprises actuation means (960) for moving the distal portion of the transcutaneous device between the retracted and the extended position when the actuation means is actuated by a subject.

6. A medical device as in claim 1, wherein the second unit is a process unit comprising a process assembly adapted to cooperate with the transcutaneous device.

7. A medical device as in claim 6, wherein the transcutaneous device is in the form of a transcutaneous sensor device, and the process assembly comprises a processor adapted to transmit and/or process data acquired via the sensor device.

8. A medical device as in claim 6, wherein the transcutaneous device is in the form of a transcutaneous access device, and the process assembly comprises a reservoir (760) adapted to contain a fluid drug, an expelling assembly (300, 580) adapted for cooperation with the reservoir to expel fluid drug out of the reservoir and through the skin of the subject via the transcutaneous access device, and a processor for controlling the expelling assembly.

9. A medical device as in claim 8, wherein the transcutaneous access device is a flexible polymeric cannula.

10. A medical device unit (1010) adapted to be releasably coupled to a second unit, the medical device unit being a transcutaneous device unit comprising:

a housing adapted for application towards a skin surface of a subject, the housing comprising a coupling portion adapted to engage the second unit, and

a transcutaneous device (1017) having a distal portion adapted to be arranged through the skin of the subject, the distal portion projecting from the housing in the vicinity of the coupling portion.

11. A medical device comprising a first unit (1010) and a second unit (1050) adapted to be releasably coupled to the first unit corresponding to a coupling zone, the first unit being a transcutaneous device unit comprising:

a housing adapted for application towards a skin surface of a subject, and

a transcutaneous device (1017) having a distal portion adapted to be arranged through the skin of the subject, the distal portion projecting from the medical device corresponding to the coupling zone.

12. A medical device comprising a first unit (1010) and a second unit (1050) adapted to be releasably coupled to the first unit, the first unit being a transcutaneous device unit comprising:

a housing adapted for application towards a skin surface of a subject, and

a transcutaneous device having a distal portion adapted to be arranged through the skin of the subject in a situation of use in which the housing has been applied towards a skin surface of the subject, the distal portion projecting from the housing thereby allowing, in a situation of use, inspection of an introduction site of the transcutaneous device through the skin when the second unit is not coupled to the first unit,

whereby the second unit when it is coupled to the first unit fully or partly covers the introduction site.

13. A method comprising the steps of:

(a) providing a transcutaneous device unit (1010) comprising a transcutaneous device and a mounting surface, the transcutaneous device having retracted position relative to the mounting surface, and an extended position in which a distal portion projects relative to the mounting surface,

(b) providing a process unit (1050) comprising a process assembly adapted to cooperate with the transcutaneous device,

(c) mounting the mounting surface to a skin surface of a subject,

(d) inserting the transcutaneous device into the subject by moving the transcutaneous device from the retracted position to the extended position, the configuration of the transcutaneous device unit allowing a subject to inspect the introduction site through the skin,

(e) assembling the transcutaneous device unit and the process unit to provide a functional communication between the process assembly and the inserted transcutaneous device, the process unit thereby fully or partly covering the introduction site.

14. A medical device comprising:

a housing comprising a mounting surface adapted for application towards a skin surface of a subject,

a transcutaneous device having a distal portion adapted to be arranged through the skin of the subject in a situation of use in which the housing has been applied towards a skin surface of the subject, the distal portion being adapted to be arranged through the skin of the subject at an inclined angle relative to the mounting surface, the cannula being directed towards a central portion of medical device, the medical device thereby, in a situation of use, substantially covering an introduction site of the transcutaneous device through the skin, and

an opening formed in the housing allowing the introduction site to be inspected.