Medical sensor assembly

• US 11,000,233 B2
• Filed: 01/23/2017
• Issued: 05/11/2021
• Est. Priority Date: 07/28/2014
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Frey, Stephan-Michael, Kube, Oliver, Walter, Helmut
• Primary Examiner(s): Kremer, Matthew
• Assistant Examiner(s): Kim, Samuel C
• Application Number:
  US15/412,916
• Publication Number:
  US 20170128011A1
• Time in Patent Office: 1,569 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• 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 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2025/0246 fixed on the skin having a cover for covering the holding means
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

A medical sensor assembly comprises a flexible plaster adapted for adhesion on the skin of a patient and a sensor configured for transdermal measuring a physiological parameter, wherein the sensor has a measuring part insertable into the skin and a contact part for providing a signal connection to a measuring unit. It is proposed that the plaster has a flap which is adhered to an intermediate section of the sensor between the measuring part and the contact part.

Claims

1. A medical sensor assembly, comprising:

a flexible patch configured for adhesion to skin of a patient;

a sensor configured for transdermal measuring of a physiological parameter, the sensor comprising (i) a measuring part insertable into the skin and formed as a flexible flat substrate with electrode pads or conducting paths thereon, (ii) a contact part configured for providing a signal connection to a signal transmitter, and (iii) an intermediate section between the measuring part and the contact part;

a flap formed as a partially cut-out or punched segment of the patch, the cut-out or punched segment forming an opening in the patch for passage of the sensor, the flap having a section with a surface that adheres to a side of the sensor in the intermediate section of the sensor; and

a hollow inserter cannula in which the sensor at least with its measuring part is positioned for insertion into the skin, wherein the cannula is retractable from the sensor and the patch while the sensor remains adhered to the flap.

2. Medical sensor assembly according to claim 1, wherein the flap is delimited by a U- or C-shaped cutting line so that a material bridge remains intact to bendably connect the flap to the remainder of the patch.

3. Medical sensor assembly according to claim 1, wherein a bottom side of the patch that is configured to face the skin is coated with a pressure-sensitive adhesive and the flap is fixedly connected to the intermediate section by means of the pressure-sensitive adhesive.

4. Medical sensor assembly according to claim 1, wherein the inserter cannula has a longitudinal slit at least along a distal section for reach-through of the flap and/or sensor.

5. Medical sensor assembly according to claim 1, wherein the intermediate section of the sensor is formed of a material strip having electrically conducting paths.

6. Medical sensor assembly according to claim 1, wherein the contact part of the sensor is arranged in direct abutment on an upper side of the patch configured to face away from the skin.

7. Medical sensor assembly according to claim 1, further comprising the signal transmitter, wherein the signal transmitter is directly fixed to the patch.

8. Medical sensor assembly according to claim 7, wherein the signal transmitter has a socket configured to receive the contact part of the sensor by transverse pressing against the patch or by lateral insertion.

9. Medical sensor assembly according to claim 1, wherein the patch defines at least one channel leading from the sensor to the margin of the patch configured for conducting blood emerging from a skin wound.

10. Medical sensor assembly according to claim 9, wherein the channel is formed by a gap between segments or layers of the patch.

11. Medical sensor assembly according to claim 10, wherein the channel comprises a capillary gap.

12. Medical sensor assembly according to claim 1, further comprising a performance indicator integrated in the patch to signal blood load or wear to the user.

13. Medical sensor assembly according to claim 1, further comprising an inserter configured for moving the inserter cannula into the skin, wherein the inserter is supported on an upper side of the patch by an adherend surface.

14. Medical sensor assembly according to claim 1, wherein the sensor comprises a glucose sensor adapted for continuous glucose monitoring.

15. A method of inserting a transdermal sensor into skin of a patient, comprising:

providing a flexible patch;

providing a sensor configured for transdermal measuring of a physiological parameter;

cutting out or punching out a segment of the patch to form a flap and an opening in the patch for passage of the sensor;

inserting the sensor into the opening;

adhering a side of the sensor to a side of the flap, whereby the sensor is adhered to the patch;

using an inserter cannula in which the sensor is at least partially positioned to insert the sensor into the skin of the patient;

adhering the patch to the skin of the patient; and

retracting the cannula from the sensor and the patch while the sensor remains adhered to the flap.

16. The method of claim 15, wherein the step of adhering the sensor to the flap takes place before the step of inserting the sensor into the skin of the patient.

17. The method of claim 15, wherein the step of adhering the sensor to the flap comprises adhering an intermediate portion of the sensor to the flap.

18. The method of claim 15, further comprising connecting a contact part of the sensor to a signal transmitter that is directly fixed to the patch.

19. The method of claim 18, further comprising connecting a socket of the transmitter with the contact part of the sensor by transverse pressing against the patch or by lateral insertion.

20. A medical sensor assembly, comprising:

a flexible patch configured for adhesion to skin of a patient;

a sensor configured for transdermal measuring of a physiological parameter, the sensor comprising (i) a measuring part insertable into the skin and formed as a flexible flat substrate with electrode pads or conducting paths thereon, (ii) a contact part configured for providing a signal connection to a signal transmitter, and (iii) an intermediate section between the measuring part and the contact part; and

a flap formed as a partially cut-out or punched segment of the patch, the cut-out or punched segment forming an opening in the patch for passage of the sensor, the opening having a closed periphery and the flap being adhered to a flat side of the sensor in the intermediate section of the sensor.