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

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.

What is claimed is: 
     
         1 . A medical device comprising:
 an elongated body having an outer distal surface at a distal end and an outer proximal surface oriented proximally of said distal surface, said distal end of said device adapted for inserting into or through the skin of a patient;   an inner lubricant coating on said distal surface;   an outer lubricant coating on said inner lubricant coating and on said proximal surface to assist insertion of said elongated body into said skin, said outer lubricant coating being removable during use of said medical device to expose said inner lubricant coating and said proximal surface of said elongated body;   said proximal surface of said elongated body having at least a portion thereof with a coefficient of friction higher than said outer lubricant 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, probe, an intravenous needle, and a glucose monitoring probe adapted for positioning in or below the skin of the patient to monitor glucose blood levels.   
     
     
         3 . The medical device of  claim 1 , wherein
 said inner lubricant coating remains on said distal surface after removal of said outer lubricant coating, and said inner lubricant coating is biodegradable to form a textured surface after removal of said outer lubricant coating.   
     
     
         4 . The medical device of  claim 1 , wherein
 said outer lubricant coating is a water soluble, uncrosslinked silicone lubricant, and said inner lubricant coating is a crosslinked silicone lubricant.   
     
     
         5 . The medical device of  claim 1 , wherein
 said outer lubricant coating is removable from said elongated body during or after insertion to expose said proximal surface of said elongated body and said inner lubricant coating.   
     
     
         6 . The medical device of  claim 5 , wherein
 said outer lubricant coating comprises a water based uncrosslinked lubricant.   
     
     
         7 . The medical device of  claim 5 , wherein
 said outer lubricant coating is removable from said elongated body by contact with body fluids to expose said proximal surface of said elongated body and said inner lubricant coating.   
     
     
         8 . The medical device of  claim 5 , wherein
 said outer lubricant 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 inner lubricant coating has a coefficient of friction greater than a coefficient of friction of said outer lubricant coating to resist movement of said elongated body after insertion and removal of said outer lubricant, and a coefficient of friction less than a coefficient of friction of said proximal surface of said elongated body.   
     
     
         10 . The medical device of  claim 1 , wherein
 said proximal surface of said elongated body defines a contact area 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 1 , wherein
 said proximal surface of said elongated body includes an inner coating that is at least partially bioabsorbable to form a textured surface after insertion of said elongated body and removal of said outer lubricant coating.   
     
     
         12 . A biosensor probe for 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, said elongated body having an outer distal surface oriented at a distal end, an outer proximal surface oriented proximally of said distal surface;   an inner lubricant coating on said distal surface of said elongated body;   a removable outer lubricant coating on said inner lubricant coating and on said proximal surface, said outer lubricant being removable during use of said probe to expose said inner lubricant coating and said proximal surface of said elongated body; and   said proximal surface of said elongated body having a contact area with a surface adapted for providing a coefficient of friction higher than a coefficient of friction of said outer lubricant coating to resist movement of said probe relative to the skin after insertion, and said inner lubricant coating is at least partially bioabsorbable or biodegradable to form a textured surface after removal of said outer lubricant coating.   
     
     
         13 . The biosensor probe of  claim 12 , wherein
 said outer lubricant coating is removable from said elongated body during or after insertion of said elongated body into said skin to expose said proximal surface.   
     
     
         14 . The biosensor probe of  claim 12 , wherein
 said inner lubricant coating comprises a crosslinked silicone polymer provided at said distal end, and   said outer lubricant coating comprises an uncrosslinked silicone lubricant overlying said inner lubricant coating at said distal end and said proximal surface.   
     
     
         15 . The biosensor probe of  claim 12 , wherein
 said outer lubricant coating is removable from said elongated body by contact with body fluids of the patient to expose the proximal surface of the elongated body, or by a shearing action by insertion of said probe in the skin.   
     
     
         16 . The biosensor probe of  claim 12 , wherein
 said inner lubricant coating has a coefficient of friction higher than a coefficient of friction of said outer lubricant coating and has 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.   
     
     
         17 . The biosensor probe of  claim 12 , wherein
 said proximal surface of said elongated body has a textured 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.   
     
     
         18 . The biosensor probe of  claim 12 , wherein
 said proximal surface of said elongated body includes a tissue growth promoting component for promoting tissue growth at an insertion site of said probe.   
     
     
         19 . 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 according to  claim 1 ;   inserting said elongated body into or through the skin of the patient such that the outer lubricant coating assists insertion of the elongated body into the skin, and removing said outer lubricant coating during or after insertion to expose said proximal surface of said elongated body and inner lubricant coating to inhibit movement of the elongated body with respect to the skin after insertion.   
     
     
         20 . The method of  claim 19 , wherein
 said medical device is selected from the group consisting of a cannula, and a biosensor probe., and a glucose.   
     
     
         21 . The method of  claim 19 , wherein said medical device is a glucose monitoring probe having a glucose detecting component, said method comprising monitoring glucose levels in the patient. 
     
     
         22 . The method of  claim 19 , wherein
 said outer lubricant coating comprises an uncrosslinked silicone lubricant, and said inner lubricant coating comprises a crosslinked silicone lubricant.   
     
     
         23 . The method of  claim 19 , comprising
 removing outer lubricant coating by contact with body fluids, or removing said outer lubricant coating by a shearing action upon insertion of said medical device into the patient.   
     
     
         24 . The method of  claim 19 , 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.