Sensors, cannulas, collars and coated surgical mesh, and corresponding systems and methods

• US 9,717,583 B2
• Filed: 09/12/2014
• Issued: 08/01/2017
• Est. Priority Date: 03/13/2014
• 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, Jim
• Application Number:
  US14/485,313
• Publication Number:
  US 20150257865A1
• Time in Patent Office: 1,054 Days
• Field of Search: None
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: Y10T 29/49888 Subsequently coating

Abstract

Disclosed herein are medical products 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. 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 dehydrated modified basement membrane preparation formed thereon, wherein the modified basement membrane preparation is 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 modified basement membrane preparation is dehydrated when in the form of a gel at room temperature.

3. The sensor of claim 1, wherein the modified basement membrane preparation is dehydrated at a temperature in the range of 1-15 Degrees centigrade after being placed on the sensor tip when the basement membrane is in the form of a liquid.

4. The sensor of claim 1, wherein the modified basement membrane preparation is dehydrated at a temperature in the range of 15-30 Degrees centigrade when the basement membrane is in the form of a gel.

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

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

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

8. The sensor of claim 7, wherein the cells and/or factors are bonded to the modified basement membrane preparation.

9. The sensor of claim 8, wherein factors are bonded to the modified basement membrane preparation and the factors comprise at least one type of vascular endothelial growth factor.

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

25. The sensor of claim 1, wherein the sensor comprises a transdermal sensor.

26. The sensor of claim 25, wherein the transdermal sensor comprises a glucose sensor.

11. 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

dehydrating the modified basement membrane preparation on the sensor.

12. The method of claim 11, further comprising:

inserting the sensor in a biological tissue, and

rehydrating the modified basement membrane preparation after insertion.

13. The method of claim 12, wherein rehydration occurs due to subcutaneous injection of a physiologic liquid before or after insertion of the sensor.

14. The method of claim 12, wherein rehydration occurs due to interstitial fluids.

15. The method of claim 11, wherein the modified basement membrane preparation comprises an adenovirus vector containing a VEGF gene.

16. The method of claim 11, wherein at least a portion of at least one of the salts, glucose, individual amino acids and vitamins from the basement membrane are removed by one or more of dialysis, buffer exchange, diafiltration, precipitation, gel filtration, affinity chromatography and electrophoresis.

27. The method of claim 11, wherein the sensor that is obtained comprises a transdermal sensor.

28. The method of claim 27, wherein the transdermal sensor that is obtained comprises a glucose sensor.

17. An implantable device comprising a layer of dehydrated modified basement membrane preparation formed thereon, wherein the modified basement membrane preparation is free from glucose, amino acids, salts and vitamins having a molecular weight of 2000 daltons or less, the layer comprising at least one member selected from the group consisting of sleeve-shaped coatings for cannulas, collars for cannulas, sleeve-shaped coatings for sensors, and collars for sensors.

18. The implantable device of claim 17, wherein the device also comprises layers of other extracellular matrices formed thereon.

19. A kit comprising the implantable device of claim 17 enclosed in sterile packaging.

29. The implantable device of claim 17, wherein the implantable device comprises a transdermal sensor.

30. The implantable device of claim 29, wherein the transdermal sensor comprises a glucose sensor.

20. An implantable device having a collar configured to be disposed at an interface between tissue and the implantable device, the collar being formed from a dehydrated modified extracellular matrix preparation, wherein the modified basement membrane preparation is free from glucose, amino acids, salts and vitamins having a molecular weight of 2000 daltons or less.

21. The implantable device of claim 20, wherein the modified extracellular matrix preparation is dehydrated prior to implantation and rehydrated after implantation.

22. A kit comprising the implantable device of claim 20 enclosed in sterile, dry packaging, wherein the modified extracellular matrix preparation is in a dehydrated form.

23. 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 an implantable device comprising at least one member selected from the group consisting of cannulas and sensors,

placing the modified basement membrane preparation in the form of a liquid or gel on the implantable device to form at least one of a sleeve and a collar on the device, and

dehydrating the modified basement membrane preparation on the implantable device.

24. The method of claim 23, further comprising:

inserting the cannula or sensor in a biological tissue, and

rehydrating the modified basement membrane preparation after insertion.

31. The method of claim 23, wherein the modified basement membrane preparation is placed on a collar.

32. The method of claim 23, wherein the modified basement membrane preparation is placed only on a portion of a sleeve, and is placed only on the portion of the sleeve that is configured to be in contact with skin tissue during use.