Coated sensors, and corresponding systems and methods

• US 10,130,288 B2
• Filed: 10/11/2016
• Issued: 11/20/2018
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Cell and Molecular Tissue Engineering, LLC
• Original Assignee: Cell and Molecular Tissue Engineering, LLC
• Inventors: Klueh, Ulrike W., Kreutzer, Donald L.
• Primary Examiner(s): Ketter, James S
• Application Number:
  US15/290,139
• Publication Number:
  US 20170135614A1
• Time in Patent Office: 770 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61K 38/1866 Vascular endothelial growth factor [VEGF]
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids

Abstract

Disclosed herein are sensors with a layer of dehydrated modified basement membrane preparation formed thereon. The basement membrane has been modified before dehydration of remove low molecular weight components. In some embodiments, the basement membrane is crosslinked. Methods of making and using the products also are disclosed.

Claims

1. An analyte sensor having a sensing element and a support element, at least one of the sensing element and support element having a crosslinked basement membrane preparation formed thereon, wherein the crosslinked basement membrane preparation is substantially free from glucose, amino acids, salts and vitamins having a molecular weight of 2000 daltons or less.

2. The sensor of claim 1, wherein the crosslinked basement membrane preparation is applied in multiple layers, and the crosslinked basement membrane preparation is dehydrated after application of each layer.

3. The sensor of claim 1, wherein the sensor also comprises layers of other extracellular matrices formed thereon.

4. The sensor of claim 1, wherein the crosslinked basement membrane preparation contains at least one of cells and factors.

5. The sensor of claim 4, wherein the cells and/or factors are bonded to the crosslinked basement membrane preparation.

6. The sensor of claim 5, wherein factors are bonded to the crosslinked basement membrane preparation and the factors comprise at least one type of vascular endothelial growth factor.

16. The sensor of claim 1, wherein the basement membrane is crosslinked using a polymer having at least two carbonyl groups.

17. The sensor of claim 16, wherein the basement membrane preparation is crosslinked with at least one of fibronectin and glutaraldehyde.

18. A kit comprising the sensor of claim 1 enclosed in sterile packaging.

7. A method comprising:

obtaining a basement membrane preparation containing basement membrane and at least one member selected from the group consisting of salts, glucose, individual amino acids, and vitamins,

removing at least a portion of at least one of the salts, glucose, individual amino acids and vitamins from the basement membrane to form a modified basement membrane preparation,

obtaining a sensor,

placing the modified basement membrane preparation in the form of a liquid or gel on the sensor, and

crosslinking and dehydrating the modified basement membrane preparation on the sensor.

8. The method of claim 7, further comprising:

inserting the sensor in a biological tissue, and

rehydrating the modified basement membrane preparation after insertion.

9. The method of claim 8, wherein rehydration occurs due to subcutaneous injection of fluids.

10. The method of claim 8, wherein rehydration occurs due to interstitial fluids.

19. The method of claim 7, wherein the modified basement membrane preparation is in the form of a gel at room temperature immediately before dehydration.

20. The method of claim 7, wherein the modified basement membrane preparation is in the form of a liquid at a temperature in the range of 1-15 Degrees Centigrade immediately before dehydration.

21. The method of claim 7, wherein the modified basement membrane is in the form of a gel at 15-30 Degrees Centigrade immediately before dehydration.

11. An analyte sensor having a sensing element and a support element, at least one of the sensing element and support element having a basement membrane preparation formed thereon that is crosslinked with a di-aldehyde, wherein the crosslinked basement membrane preparation is substantially free from glucose, amino acids, salts and vitamins having a molecular weight of 2000 daltons or less.

12. The sensor of claim 11, wherein the basement membrane preparation is applied in multiple layers, and the modified basement membrane preparation is dehydrated after application of each layer.

13. The sensor of claim 11, wherein the sensor also comprises layers of other extracellular matrices formed thereon.

14. The sensor of claim 11, wherein the basement membrane preparation contains at least one of cells and factors.

15. The sensor of claim 14, wherein the cells and/or factors are bonded to the basement membrane preparation.