Skin interface device having a skin attachment device and method to implant same

Abstract

The present invention provides a skin attachment device for use with implantable medical devices which extend through the skin for prolonged durations.

1 - 58 . (canceled) 
     
     
         59 . A method of implanting a skin interface device at an incision in a patient's skin, the method comprising:
 positioning a portion of the patient's skin defining the incision into a groove of an
 annular ring, the annular ring having an aperture extending therethrough along an 
 aperture axis, the annular ring comprising 
 a radially-outward surface; 
 a first flange extending from the radially-outward surface of the annular ring away from the aperture axis; and 
 a second flange extending from the radially-outward surface of the annular ring away from the aperture axis and spaced apart from the first flange along the aperture axis, _p 2  wherein the groove extends between the first flange and the second flange; 
   suturing the annular ring to the portion of the patient's skin;   coupling a fixturing assembly to the annular ring.   
     
     
         60 . The method of  claim 59 , further comprising:
 positioning the annular ring around a skin interface base such that a protrusion of the skin interface device base extends at least partially through the aperture of the annular ring.   
     
     
         61 . The method of  claim 60  wherein at least a portion of the protrusion of the skin interface device base has an outer cross-section sized and shaped to match an inner cross-section of at least a portion of the aperture of the annular ring. 
     
     
         62 . The method of  claim 60 , further comprising:
 tightening the fixturing assembly to the protrusion of the skin interface device base to form a rigid connection between the fixturing assembly and the skin interface device base.   
     
     
         63 . The method of  claim 59  wherein the radially-outward surface of the annular ring has an elliptical shape when observed along the aperture axis. 
     
     
         64 . The method of  claim 59  wherein coupling the fixturing assembly to the annular ring comprises fastening the fixturing assembly to the annular ring using one or more mechanical fasteners. 
     
     
         65 . The method of  claim 59  wherein positioning the portion of skin defining the incision into the groove comprises positioning the first flange under the skin of the patient. 
     
     
         66 . The method of  claim 59  wherein at least a portion of the groove is texturized to promote tissue growth therein. 
     
     
         67 . The method of  claim 59  wherein coupling the fixturing assembly to the annular ring comprises connecting a first portion of the fixturing assembly to a second portion of the fixturing assembly, and wherein the first and second portion of the fixturing assembly are positioned on a side of the fixturing assembly opposite the patient's skin. 
     
     
         68 . The method of  claim 67  wherein connecting the first portion of the fixturing assembly to the second portion of the fixturing assembly comprises inserting a fastener through the first portion into a threaded aperture of the second portion. 
     
     
         69 . A method of implanting a skin interface device at an incision in a patient's skin, the method comprising:
 positioning an annular ring around a skin interface base such that a protrusion of the skin interface device base extends at least partially through an aperture extending through the annular ring, the annular ring comprising:
 a radially-outward surface; 
 a first flange extending from the radially-outward surface of the annular ring away from the aperture axis; 
 a second flange extending from the radially-outward surface of the annular ring away from the aperture axis and spaced from the first flange along the aperture axis; and 
 a groove extending between the first flange and the second flange; 
   positioning a portion of the patient's skin defining the incision into the groove; and   attaching a skin interface device cap to the protrusion of the skin interface device base such that the skin interface device cap is positioned at least partially exterior to the patient's skin and the protrusion of the skin interface device is positioned at least partially under the patient's skin.   
     
     
         70 . The method of  claim 69 , further comprising communicatively coupling an electrical winding of the skin interface device cap to an electrical winding of the skin interface device base. 
     
     
         71 . The method of  claim 70 , further comprising powering one or more components of the skin interface device within the patient's body via a connection between the winding of the skin interface device cap and the winding of the skin interface device base. 
     
     
         72 . The method of  claim 70  wherein rotation of the skin interface device cap with respect to the skin interface device base does not alter electrical or magnetic coupling between the winding of the skin interface device cap and the winding of the skin interface device base. 
     
     
         73 . The method of  claim 70 , further comprising fixing the winding of the skin interface device cap laterally and axially with respect to the winding of the skin interface device base when the skin interface device cap is attached to the skin interface device base. 
     
     
         74 . The method of  claim 70 , wherein the communicatively coupling the electric winding of the skin interface device cap to the electrical winding of the skin interface device base comprises magnetically connecting the electrical winding of the skin interface device cap to the electrical winding of the skin interface device base. 
     
     
         75 . A method of implanting a skin interface device at an incision in a patient's skin, the method comprising:
 positioning a portion of the patient's skin defining the incision into a groove of an annular ring;   positioning the annular ring around a skin interface base such that a protrusion of the skin interface device base extends at least partially through an aperture of the annular ring, the skin interface base including a first winding;   attaching a skin interface device cap to the skin interface device base such that a second winding of the skin interface device cap is electrically connected to the first winding of the skin interface device base, wherein, when the skin interface device cap is attached to the skin interface device base, the skin interface device cap is positioned at least partially exterior to the patient's skin and the protrusion is positioned at least partially under the patient's skin,   wherein   the skin interface device comprises
 a processor in electrical communication with the first winding; 
 a non-transitory computer readable medium in communication with the processor; and 
 data encoded in the non-transitory computer readable medium. 
   
     
     
         75 . The method of  claim 75 , further comprising storing the data as a function of time. 
     
     
         76 . The method of  claim 76  wherein the data includes one or more of a patient medical history or a physiological parameter. 
     
     
         77 . The method of  claim 77  wherein the data includes EKG signals, a pulse of the patient, body temperature of the patient, blood pressure of the patient, and/or a blood analyte concentration of the patient. 
     
     
         78 . The method of  claim 75 , further comprising connecting an implanted EKG sensor to the skin interface device base.