MEDICAL DEVICE AND METHOD FOR PRODUCING A MEDICAL DEVICE

• US 20170143243A1
• Filed: 02/02/2017
• Published: 05/25/2017
• Est. Priority Date: 08/06/2014
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Deck, Frank
• Granted Patent: US 10,939,858 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/6849 in combination with a needle set
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2202/21 Pharmaceuticals, e.g. medicaments, artificial body parts

Abstract

Disclosed herein is an inventive medical device. The medical device includes an implantable device, such as an electrochemical sensor. The implantable device has an implantable portion configured for insertion into a patient, a contact portion configured for connection to another device, and an interconnecting portion connecting the implantable portion and the contact portion. A housing is provided that has a first part that is removably connectable with a second part to form a sterile packaging to seal the implantable portion against a surrounding environment. The first part comprises a first sealing surface and the second part comprises a second sealing surface and the first and second sealing surfaces interact to form a sealing area. The interconnecting portion of the implantable device extends through the sealing area. An inventive method of producing the medical device is also disclosed.

Claims

1. A medical device, comprising:

an implantable device having (i) an implantable portion adapted for at least partially being implanted into a body tissue of a user, (ii) a contact portion configured for connection to a further component, and (iii) an interconnecting portion connecting the implantable portion and the contact portion; and

a housing configured to receive the implantable portion, the housing comprising a first part removably connectable with a second part to form a sterile packaging to seal the implantable portion against a surrounding environment, wherein the first part comprises a first sealing surface and the second part comprises a second sealing surface and the first and second sealing surfaces interact to form a sealing area, wherein the interconnecting portion extends through the sealing area.

2. The medical device according to claim 1, wherein the implantable device comprises at least one of:

an implantable sensor for detecting at least one analyte in one or both of a body tissue or a body fluid;

a cannula;

a tube.

3. The medical device according to claim 1, wherein the interconnecting portion is clamped between the first sealing surface and second sealing surface.

4. The medical device according to claim 1, wherein the housing is at least partially cylindrical and has a longitudinal axis, wherein the implantable portion received within the sterile packaging at least partially extends parallel to the longitudinal axis.

5. The medical device according to claim 4, wherein the contact portion is bent away from the longitudinal axis.

6. The medical device according to claim 1, wherein the first part and second part are removably connectable by one or more of:

a form-fit connection;

a force-fit connection;

a snap-fit connection.

7. The medical device according to claim 1, wherein the contact portion is adapted for providing at least one of a mechanical contact or an electrical contact to a further component associated with the implantable device, wherein the contact portion comprises at least one electrical contact, wherein the further component comprises an electronic device connected to the electrical contact outside the sterile packaging.

8. The medical device according to claim 7, wherein the implantable device comprises an electrochemical sensor for electrochemically detecting at least one analyte in one or both of a body tissue or a body fluid, wherein the electronic device is configured for one or both of measuring or recording sensor signals generated by the electrochemical sensor.

9. The medical device according to claim 1, further comprising a transcutaneous insertion element fixedly mounted to the first part of the housing.

10. An insertion kit, comprising at least one medical device according to claim 1 and further comprising at least one insertion device, wherein the insertion device is adapted for mechanically interfacing with the medical device and for at least partially implanting at least one implantable portion of the medical device into a body tissue of a user.

11. A method for producing a medical device, comprising:

providing an implantable device having (i) an implantable portion adapted for at least partially being implanted into a body tissue of a user, (ii) a contact portion configured for connection to a further component, and (iii) an interconnecting portion connecting the implantable portion and the contact portion;

providing a first housing part having a first sealing surface and providing a second housing part having a second sealing surface; and

removably connecting the first housing part to the second housing part to form a sterile packaging within which the implantable portion is disposed;

wherein the step of removably connecting the first housing part and second housing part creates a sealing area between the first and second seals, and the interconnecting portion is led through the sealing area.

12. The method according to claim 11, wherein the step of removably connecting is performed in a cleanroom or under cleanroom conditions.

13. The method according to claim 11, further comprising at least one radiation sterilization step, wherein in the radiation sterilization step the implantable portion is exposed to sterilizing radiation within the housing.

14. The method according to claim 11, further comprising:

connecting an electrical contact of the contact portion to an electronic device located outside the sterile packaging;

after receiving the implantable portion in the housing and after sealing the implantable portion against the surrounding environment, sterilizing the electronic device by chemical sterilization, whereby the implantable portion remains unaffected by the chemical sterilization.

15. The method according to claim 14, further comprising an attaching step in which the electronic device is connected to the electrical contact by one or more of welding, soldering or bonding, wherein the attaching step is performed in a non-cleanroom environment.

16. The method according to claim 15, wherein the attaching step is performed after a radiation sterilization step of the implantable device.