Medical Skin Mountable Device And System

• US 20090131860A1
• Filed: 04/07/2006
• Published: 05/21/2009
• Est. Priority Date: 04/13/2005
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Nielsen, Ole Christian
• Granted Patent: US 8,298,172 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/6833 Adhesive patches
• 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 2005/1581 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 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A medical device is provided comprising a transcutaneous device unit and a process unit. The transcutaneous device unit may comprise a transcutaneous device for transporting a fluid through a skin portion of a subject, and a mounting surface adapted for application to the skin of the subject. The process unit may comprise a reservoir adapted to contain a fluid drug, the reservoir comprising an outlet means allowing the transcutaneous device to be arranged in fluid communication with an interior of the reservoir, and an expelling assembly for expelling a fluid drug out of the reservoir and through the skin of the subject via the transcutaneous device. The transcutaneous device unit and the process unit further comprise coupling means allowing the reservoir unit to be secured to the transcutaneous device unit in the situation of use. By this arrangement a two-unit system is provided which can be used in a convenient and cost-effective manner.

Claims

1. A medical device, comprising a transcutaneous device unit (2, 502, 700, 900, 1010, 1850) and a process unit (5, 505, 1050, 1860),

a) the transcutaneous device unit comprising:

a mounting surface (904, 1020), adapted for application to the skin of a subject,

a transcutaneous device (530, 651, 771, 951, 1017, 1852) comprising a distal end adapted to be inserted through the skin of a subject, the distal end being moveable between an initial position in which the distal end is retracted relative to the mounting surface, and an extended position in which the distal end projects relative to the mounting surface,

b) the process unit comprising;

a process assembly (300, 595, 1861) adapted to cooperate with the transcutaneous device,

wherein the transcutaneous device unit and the process unit are adapted to be secured to each other to form a unitary device.

2. A medical device as in claim 1, wherein the transcutaneous device (651, 771, 951, 1852) is provided in combination with a pointed insertion needle (661, 761, 932, 1853) being retractable relative to the transcutaneous device.

3. A medical device as in claim 2, wherein the insertion needle is a hollow needle (932) arranged coaxially with and outside the transcutaneous device (951) and being axially moveable relative thereto, the needle comprising a distal portion adapted to penetrate the skin of the subject, wherein the medical device is transformable between:

a first state in which the transcutaneous device and the needle are retracted relative to the mounting surface,

a second state in which the transcutaneous device and the needle are extended relative to the mounting surface with the distal end of the needle projecting relative to the distal portion of the transcutaneous device thereby allowing the transcutaneous device to be introduced through the skin of the subject, and

a third state in which the distal end of the needle is retracted relative to the distal portion of the transcutaneous device.

4. A medical device as defined in claim 1, wherein the transcutaneous device unit comprises actuation means (520, 658, 751, 960) for moving the distal end of the transcutaneous device between the initial and the extended position when the actuation means is actuated.

5. A medical device as in claim 1, wherein the transcutaneous device is in the form of a transcutaneous sensor device (1852), and the process assembly comprises a processor (1861) adapted to transmit and/or process data acquired via the sensor device.

6. A medical device as in claim 1, wherein the transcutaneous device is in the form of a transcutaneous access device, and the process assembly comprises a reservoir (595) 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.

7. A medical device as in claim 1, wherein the process unit is adapted to be releasably coupled to the transcutaneous device unit thereby, in a situation of use, substantially covering an introduction site of the transcutaneous device through the skin, and wherein at least partial removal of the process unit from the transcutaneous device unit at least partially uncovers the introduction site.

8. A medical device as in claim 1, the transcutaneous device unit (1010) comprising a housing portion (1015) to which the transcutaneous device is mounted, and a flexible sheet member (1019) provided with an adhesive layer on its lower surface (1020), this allowing the transcutaneous device unit to be attached to the skin of the subject.

9. A system comprising:

a medical device as in claim 1, and

a remote control unit (1830, 1940) comprising a processor, the medical device and the remote control unit being adapted to transmit data therebetween.

10. A system as in claim 9, wherein the remote control unit is adapted to receive externally supplied values and to calculate a bolus amount of drug to be infused based upon the externally supplied values.

11. A system as in claim 10, wherein the remote control unit is adapted to calculate a bolus amount of drug to be infused based upon externally supplied values representing material to be ingested by the body of the subject.

12. A system as in claim 10, further comprising a first analyte sensor (1830, 1831) device adapted to provide data indicative of a concentration of the first analyte in the user, the remote control unit comprising an infusion calculator for calculating a bolus or infusion rate on the basis of data supplied by the first analyte sensor.

13. A system as in claim 12, further comprising a second analyte sensor device (1810) adapted to provide data indicative of a concentration of the second analyte in the user, the remote control unit comprising an infusion calculator for calculating a bolus or infusion rate on the basis of data supplied by the first and second analyte sensors.

14. A system as in claim 13, wherein the first and second analytes are blood glucose, the first analyte sensor is a BGM, the second analyte sensor is a CGM, and the remote control unit is adapted to calculate an amount or infusion rate of insulin.

15. A system comprising:

a first transcutaneous device unit (1930) and a first process unit (1920) as defined in claim 1,

at least one further transcutaneous device unit being different from the first transcutaneous device unit, whereby each combination of a transcutaneous device unit and a process unit provides different capabilities.

16. A system comprising:

a first transcutaneous device unit (1930) and a first process unit (1920) as defined in claim 1,

at least one further process unit (1911, 1912, 1913) being different from the first process unit, whereby each combination of a transcutaneous device unit and a process unit provides different capabilities.

17. A medical device or system as defined in claim 1, comprising releasable mating coupling means (506, 511, 1013, 1052) for securing the transcutaneous device unit and the process unit to each other to form a substantially rigid connection there between.

18. A method comprising the steps of:

providing a transcutaneous device unit (502, 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 end projects relative to the mounting surface,

providing a process unit (505, 1050) comprising a process assembly adapted to cooperate with the transcutaneous device,

mounting the mounting surface to a skin surface of a subject,

inserting the transcutaneous device into the subject by moving the transcutaneous device from the retracted position to the extended position,

assembling the transcutaneous device unit and the process unit to form a unitary device and provide a functional communication between the process assembly and the inserted transcutaneous device.

19. A method comprising the steps of:

providing a transcutaneous device unit (502, 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 end projects relative to the mounting surface,

providing a process unit (505, 1050) comprising a process assembly adapted to cooperate with the transcutaneous device,

mounting the mounting surface to a skin surface of a subject,

assembling the transcutaneous device unit and the process unit to form a unitary device and provide a functional communication between the process assembly and the inserted transcutaneous device,

inserting the transcutaneous device into the subject by moving the transcutaneous device from the retracted position to the extended position.

20. A method as in claim 19, wherein the transcutaneous device is moved from the retracted position to the extended position automatically when the transcutaneous device unit and the process unit are assembled.

21. A method comprising the steps of:

providing a transcutaneous device unit (502) 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 end projects relative to the mounting surface,

providing a process unit (505) comprising a process assembly adapted to cooperate with the transcutaneous device,

assembling the transcutaneous device unit and the process unit to form a unitary device and provide a functional communication between the process assembly and the inserted transcutaneous device,

mounting the mounting surface to a skin surface of a subject,

inserting the transcutaneous device into the subject by moving the transcutaneous device from the retracted position to the extended position.