Device and Method for Inhibiting Movement of a Medical Device in a Patient

• US 20150328370A1
• Filed: 12/20/2012
• Published: 11/19/2015
• Est. Priority Date: 12/20/2012
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Petisce, James, McCaffrey, Nathaniel, Limaye, Amit
• Granted Patent: US 10,799,621 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 5/6852 Catheters
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 2430/00 Materials or treatment for tissue regeneration
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: F04C 2270/041 Controlled or regulated
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A medical device such as a cannula, catheter, needle or biosensing probe includes an elongated body for penetrating, inserting and/or positioning in or through the skin of a patient. The elongated body has an outer surface that when positioned in the patient with a coefficient of friction sufficient to inhibit movement between the elongated body on the skin at the insertion site to inhibit irritation at the infusion site. A lubricious coating is provided on the elongated body to assist in penetration and/or insertion of the elongated body into the patient. The lubricious coating can be removed by a shearing action by the insertion of the elongated body into the patient and/or by absorption of the lubricious coating to expose the outer surface of the elongated member.

Claims

1. A medical device comprising:

an elongated body having an outer surface, a distal end and a proximal end, said distal end of said device adapted for inserting into or through the skin of a patient;

an outer lubricious coating applied at least at said distal end on said outer surface to assist insertion of said elongated body into said skin;

said outer surface of said elongated body having at least a portion thereof with a coefficient of friction higher than said lubricious coating to inhibit movement of said elongated body with respect to the skin after insertion and to inhibit irritation of the skin.

2. The medical device of claim 1, wherein

said elongated body is selected from the group consisting of a cannula, sensor and probe.

3. The medical device of claim 1, wherein

said elongated body is a glucose monitoring probe adapted for positioning in or below the skin of the patient to monitor glucose blood levels.

4. The medical device of claim 1, wherein

said medical device comprises an intravenous needle.

5. The medical device of claim 1, wherein

said outer lubricious coating is removable from said elongated body during or after insertion to expose said outer surface of said elongated body.

6. The medical device of claim 5, wherein

said outer lubricious coating comprises a water based uncrosslinked lubricant.

7. The medical device of claim 5, wherein

said outer lubricious coating is removable from said elongated body by contact with body fluids to expose said outer surface of said elongated body.

8. The medical device of claim 5, wherein

said outer lubricious coating is removable from said elongated body by a shearing action upon insertion of said elongated body in the skin.

9. The medical device of claim 1, wherein

said outer surface of said elongated body has an inner coating between said outer lubricious coating and said elongated body, said inner coating having a coefficient of friction greater than a coefficient of friction of said outer lubricious coating.

10. The medical device of claim 1, wherein

said outer surface of said elongated body has a contact area adapted for contacting the skin after insertion, said contact area having a textured surface to inhibit movement of said elongated body with respect to said skin and inhibit irritation of said skin after insertion.

11. The medical device of claim 10, wherein

said contact area of said outer surface of said elongated body includes an inner coating that is at least partially bioabsorbable to form said textured surface after insertion of said elongated body.

12. The medical device of claim 1, wherein

said outer surface of said elongated body includes at least one component for promoting tissue growth at an insertion site of said elongated body.

13. A biosensor probe for penetrating and inserting intravenously or into or through the skin of a patient, said biosensor probe comprising:

an elongated body having a sensor for detecting an analyte, a proximal end, a distal end and an outer surface;

a lubricious coating applied at least to said distal end of said elongated body to assist penetration of and insertion intravenously or into the skin of said patient; and

said elongated body having at least one contact area with a surface adapted for providing a coefficient of friction higher than a coefficient of friction of said lubricious coating to resist movement of said cannula relative to the skin after insertion.

14. The biosensor probe of claim 13, wherein

said lubricious coating is removable from said elongated body during or after insertion of said elongated body into said skin to expose said outer surface.

15. The biosensor probe of claim 14, wherein

said lubricious coating comprises a crosslinked silicone polymer provided at said distal end, and

said elongated body includes an outer coating of an uncrosslinked silicone lubricant overlying said lubricious coating at said distal end and said contact area.

16. The biosensor probe of claim 13, wherein

said outer coating comprises a silicone lubricant.

17. The biosensor probe of claim 15, wherein

said outer coating is removable from said elongated body by contact with body fluids of the patient to expose the outer surface of the elongated body.

18. The biosensor probe of claim 14, wherein

said lubricious coating is removed by a shearing action by insertion of said cannula in the skin.

19. The biosensor probe of claim 14, wherein

said outer surface of said elongated body has an inner coating between said elongated body and said lubricious coating, said inner coating having a coefficient of friction higher than a coefficient of friction of said lubricious coating and having a coefficient of friction sufficient to inhibit movement of said elongated body with respect to the skin and inhibit irritation of the skin by sliding movement.

20. The biosensor probe of claim 14, wherein

said lubricious coating is removable from said elongated body during or after insertion of said cannula to expose said outer surface of said elongated body, and where said elongated body has a textured surface to define said outer surface with a coefficient of friction sufficient to inhibit movement between said biosensor and the tissue and to a lubricity sufficient to allow removal of said biosensor with reduced irritation to the patient.

21. The biosensor probe of claim 14, wherein

said outer surface of said elongated body has a coating that is at least partially bioabsorbable upon insertion of said cannula into the skin, said bioabsorbable coating forming a textured surface to inhibit movement of said probe with respect to the skin upon insertion in the skin.

22. The biosensor probe of claim 13, wherein

said outer surface of said elongated body includes at least one tissue growth promoting component for promoting tissue growth at an insertion site of said cannula.

23. A method of inhibiting movement of a medical device inserted through the skin of a patient, said method comprising the steps of:

providing the medical device with an elongated body having a distal end, a proximal end, an outer surface and a lubricious coating on said outer surface at least at said distal end, said outer surface of said elongated body having a coefficient of friction greater than a coefficient of friction of said lubricious coating;

inserting said elongated body into or through the skin of the patient such that the lubricious coating assists insertion of the elongated body into the skin and said outer surface of said elongated body contacts the skin to inhibit movement of the elongated body with respect to the skin after insertion.

24. The method of claim 23, wherein

said medical device is selected from the group consisting of a cannula and a biosensor probe.

25. The method of claim 23, wherein

said medical device is a glucose monitoring probe having a glucose detecting component, said method comprising

inserting said glucose monitoring probe in the patient and monitoring blood glucose levels in the patient.

26. The method of claim 23, said method further comprising

inserting said medical device subcutaneously or intravenously into the patient.

27. The method of claim 23, wherein

said lubricious coating is removable, and said method comprises

removing said lubricious coating upon insertion of said elongated body in the patient to expose said outer surface of said elongated body and bringing said outer surface into contact with said skin to inhibit movement of said elongated body relative to said skin.

28. The method of claim 27, wherein

said lubricious coating comprises an uncrosslinked silicone lubricant.

29. The method of claim 23, wherein

said lubricious coating is removable from said elongated body by contact with body fluids and said method comprises

inserting said elongated body into the skin for sufficient time to remove said lubricious coating to expose said outer surface of said elongated body and inhibit movement of said elongated body with respect to said skin.

30. The method of claim 27, comprising

removing said lubricious coating by a shearing action upon insertion of said elongated body in said skin.

31. The method of claim 23, wherein

said elongated body has an inner coating between said lubricious coating and said outer surface of said elongated body, said method comprising

removing said lubricious coating during or after insertion of said elongated body into the skin to expose said inner coating.

32. The method of claim 31, wherein

said inner coating is a crosslinked silicone lubricant applied at the distal end of the medical device, and the outer coating is an uncrosslinked silicone lubricant overlying the inner coating and overlying at least a portion of a contact area of the medical device.

33. The method of claim 31, wherein

said inner coating is at least partially bioabsorbable and said method comprises

inserting said elongated body in the skin for a time sufficient to erode at least part of a surface thereof to form a roughened surface in contact with said skin to inhibit movement of said elongated body with respect to said skin.

34. The method of claim 23, wherein

said outer surface of said elongated body includes a tissue growth promoting component, and where said method comprises

inserting said elongated body in said skin for sufficient time to remove said lubricious coating to expose said tissue growth promoting component to said skin to promote tissue growth at an insertion site to inhibit movement of said elongated body with respect to said skin and inhibit irritation at said insertion site.