Medical device and method for producing a medical device

Patent metadata

Field	Value
Publication number	US-10939858-B2
Application number	US-201715423245-A
Country	US
Kind code	B2
Filing date	Feb 2, 2017
Priority date	Aug 6, 2014
Publication date	Mar 9, 2021
Grant date	Mar 9, 2021

Abstract

An inventive 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.

First claim

What is claimed is:

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 and second parts are configured such that removing the first part from the second part exposes the implantable portion for insertion in the body tissue of the user, 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 and wherein the contact portion is folded away from a longitudinal axis of the housing.

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 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 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.

6. 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.

7. The medical device according to claim 6 , 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.

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

9. 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 the body tissue of a user.

10. 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;
removably connecting the first housing part to the second housing part to form a sterile packaging within which the implantable portion is disposed; and
folding the contact portion away from a longitudinal axis of the housing;
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, wherein the first and second parts are configured such that removing the first part from the second part exposes the implantable portion for insertion in the body tissue of the user.

11. The method according to claim 10 , wherein the step of removably connecting is performed in a cleanroom or under cleanroom conditions.

12. The method according to claim 10 , 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.

13. The method according to claim 10 , 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.

14. The method according to claim 13 , 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.

15. The method according to claim 14 , wherein the attaching step is performed after a radiation sterilization step of the implantable device.

16. A medical device, comprising:
a substantially flat implantable sensor having two oppositely facing broad sides and two lateral edges, an implantable portion adapted for at least partially being implanted into a body tissue of a user, a contact portion configured for connection to a further component, and 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 and the first and second parts are configured such that removing the first part from the second part entirely removes the housing from a tip of the implantable portion and exposes the implantable portion for insertion in the body tissue of the user, 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, further wherein the first sealing surface presses onto one of the two broad sides and the second sealing surface presses onto the other of the two broad sides, whereby the interconnecting portion is sandwiched between the first and second sealing surfaces.

17. A method for producing a medical device, comprising:
providing a substantially flat implantable sensor having two oppositely facing broad sides and two lateral edges, an implantable portion adapted for at least partially being implanted into a body tissue of a user, a contact portion configured for connection to a further component, and 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;
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 first and second parts are configured such that removing the first part from the second part entirely removes the housing from a tip of the implantable portion and exposes the implantable portion for insertion in

Assignees

• Roche Diabetes Care Inc

Inventors

• Deck Frank

Classifications

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61B2562/18

  Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage · CPC title

• A61L2/206

  Ethylene oxide · CPC title

• A61B5/14865 Primary

  invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors · CPC title

• A61B2562/242

  Packaging, i.e. for packaging the sensor or apparatus before use · CPC title