Medical device comprising a multipart housing

• US 9,872,642 B2
• Filed: 01/11/2013
• Issued: 01/23/2018
• Est. Priority Date: 07/12/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Deck, Frank
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/739,755
• Publication Number:
  US 20130131468A1
• Time in Patent Office: 1,838 Days
• Field of Search: 600310-344
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61B 5/688 using adhesives
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A medical device for carrying out at least one medical function, comprising at least one element that can be at least partially inserted into a body tissue of a user and further comprising at least one housing that can be placed on a skin surface of the user. The housing has a multipart design and comprises at least one functional component. The functional component can be connected to the insertable element. The housing further comprises at least one protective component. The protective component is designed to at least partially enclose the functional component. The protective component can be connected to the functional component, particularly after insertion of the insertable element.

Claims

1. A medical device for carrying out at least one medical function, comprising:

an insertable element that can be at least partially inserted into a body tissue of a user at an insertion site at which the insertable element passes through the skin surface of the user; and

a housing adapted for placement on a skin surface of the user, the housing comprising;

a functional component comprising an electronic module configured to control the insertable element, the functional component being connectable to the insertable element; and

a protective component that is connectable to the functional component and wherein the functional component and the protective component each have a self-adhesive surface adapted to contact the skin surface;

wherein, when the protective component is connected to the functional component, the protective component at least partially surrounds the functional component and the housing defines a free space for access to the insertion site from above.

2. The medical device of claim 1, wherein, when the protective component is connected to the functional component and positioned on the skin surface, the insertion site is completely surrounded by the housing.

3. The medical device of claim 1, wherein an outer edge of the protective component is adapted to completely enclose a projection of the functional component and of the insertable element onto the skin surface of the user.

4. The medical device of claim 1, wherein, when the protective component is connected to the functional component and positioned on the skin surface, the insertion site is arranged substantially centrally with respect to a contact face of the housing.

5. The medical device of claim 1, wherein the insertable element comprises a sensor for detection of at least one analyte in a body fluid or an insulin pump.

6. The medical device of claim 1, wherein at least one function of the functional component remains operable when the functional component is disconnected from the protective component.

7. The medical device as claimed in claim 6, wherein the at least one function of the functional component comprises an analysis of a body fluid that can be performed by the functional component in cooperation with the insertable element.

8. The medical device of claim 7, wherein the medical function further comprises delivering medication.

9. The medical device of claim 1, wherein the housing is flexible.

10. The medical device of claim 1, wherein the insertable element is connectable to one side of the functional component, wherein the functional component has at least one depression facing toward the one side.

11. The medical device of claim 1, wherein the housing further comprises a protective cover that at least partially covers the protective component and the functional component on a side of the housing that is adapted to face away from the skin surface.

12. The medical device of claim 1, wherein, when the protective component is connected to the functional component, the functional component is configured to cooperate mechanically, electrically or fluidically with the insertable element.

13. The medical device as claimed in claim 1, wherein the protective component has a seat with an opening configured to receive the functional component.

14. The medical device of claim 1, wherein the protective component is connectable to the functional component with a form fit and/or force fit.

15. The medical device of claim 1, wherein the protective component has an opening into which the functional component is configured to be completely or partially fitted.

16. The medical device of claim 15, wherein the shape of the opening corresponds to an outer shape of the functional component.

17. A method of using a medical device having an insertable element and a functional component that is connectable to the insertable element, the method comprising:

connecting the insertable element to the functional component;

connecting a protective component to the functional component and at least partially surrounding the functional component with the protective component;

inserting the insertable element at least partially into the skin of a user at an insertion site;

adhering the protective component directly to the skin surface and adhering the functional component directly to the skin surface of the user;

providing a free space with the housing for access to the insertion site from above; and

carrying out at least one medical function on the user with the medical device.

18. The method of claim 17, wherein the medical function comprises detection of at least one analyte in a body fluid or infusing insulin.

19. The method of claim 17, further comprising connecting the protective component to the functional component after the step of inserting of the insertable element.

20. The method of claim 17, wherein, after the protective component is connected to the functional component, the protective component borders the functional component.

21. The method of claim 20, further comprising completely surrounding the functional component with the protective component.

22. A medical device for carrying out at least one medical function, comprising:

an insertable element that can be at least partially inserted into a body tissue of a user; and

a housing adapted for placement on a skin surface of the user, the housing comprising;

a functional component comprising an electronic module for the insertable element, the functional component being connectable to the insertable element; and

a protective component configured to at least partially enclose the functional component, wherein the protective component is connectable to the functional component and wherein the functional component and the protective component each have a self-adhesive surface adapted to contact the skin surface;

wherein, the functional component is operable for analysis of a body fluid when the functional component is disconnected from the protective component.

23. A method of using a medical device having an insertable element and a functional component that is connectable to the insertable element, the method comprising:

connecting the insertable element to the functional component;

connecting a protective component to the functional component and at least partially surrounding the functional component with the protective component;

inserting the insertable element at least partially into the skin of a user at an insertion site;

adhering the protective component directly to the skin surface and adhering the functional component directly to the skin surface of the user;

carrying out at least one analysis of a body fluid; and

maintaining operation of the functional component for analysis of the body fluid when the functional component is disconnected from the protective component.