Device and method for inhibiting movement of a medical device in a patient

• US 10,799,621 B2
• Filed: 12/20/2012
• Issued: 10/13/2020
• 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
• Primary Examiner(s): Kremer, Matthew
• Application Number:
  US14/654,493
• Publication Number:
  US 20150328370A1
• Time in Patent Office: 2,854 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 5/6852 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, a proximal end, and a skin contact area spaced from said distal end, said distal end of said elongated body adapted for inserting into or through a skin of a patient;

an inner coating of a lubricant on said outer surface at said distal end of said elongated body;

a removable outer lubricious coating applied on said inner coating and on said skin contact area of said outer surface of said elongated body to assist insertion of said elongated body into said skin, said inner coating formed at said distal end between said outer lubricious coating and said elongated body, said outer coating being removable from said skin contact area of said elongated body and removable from said inner coating by body fluids from said patient to expose said skin contact area of said elongated body and expose said inner coating, said inner coating having a coefficient of friction greater than a coefficient of friction of said outer lubricious coating to resist movement of said elongated body with respect to said skin of said patient after the insertion into the skin and removal of said outer lubricious coating, said inner coating comprising a crosslinked silicone lubricant and said outer lubricious coating comprising a water based uncrosslinked silicone lubricant;

said outer surface of said elongated body having a coefficient of friction higher than said inner coating and higher than said outer lubricious coating, where said skin contact area of said elongated body inhibits the movement of said elongated body with respect to the skin after the insertion and after the removal of said outer coating from said skin contact area and said inner coating, and to inhibit irritation of the skin at an insertion site.

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 skin contact area has a textured surface to inhibit the movement of said elongated body with respect to said skin and inhibit the irritation of said skin after the insertion.

6. The medical device of claim 1, wherein

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

7. A biosensor probe for penetrating and inserting through a 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 with a skin contact area spaced from said distal end;

an inner coating of a lubricant applied on said outer surface at a tip of said distal end of said elongated body, and a removable outer coating of a lubricant overlying said inner coating and said skin contact area of said elongated body to assist penetration and insertion through the skin of said patient, said outer coating being removable during or after the insertion into the patient to expose said skin contact area and to expose said inner coating; and

said skin contact area of said elongated body being spaced from said inner coating at said tip, said skin contact area having a surface adapted for contacting the skin and having a coefficient of friction higher than a coefficient of friction of said inner coating and higher than a coefficient of friction of said outer coating to resist movement of said elongated body relative to the skin after the insertion and after removal of said outer coating, said inner coating comprising a crosslinked silicone lubricant having a coefficient of friction greater than said coefficient of friction of said outer coating-, and said outer coating comprising a water-based uncrosslinked silicone lubricant whereby said outer coating is removable from said inner coating and said skin contact area of said elongated body during or after the insertion of said elongated body into said skin to expose said inner coating and to expose said skin contact area to inhibit the movement of said elongated body relative to said skin at an insertion site in the patient after the removal of said outer coating.

8. The biosensor probe of claim 7, wherein

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

9. The biosensor probe of claim 7, wherein said outer coating is removable by a shearing action by the insertion of said elongated body into the skin.

10. The biosensor probe of claim 7, wherein said outer coating is removable from said elongated body during or after the insertion of said elongated body 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 elongated body and tissue.

11. The biosensor probe of claim 7, wherein

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