Apparatus and methods to install, support and/or monitor performance of intraosseous devices

Abstract

Various types of supporting structures, supporting devices, attachment mechanisms and attachment techniques may be provided to support and/or stabilize an intraosseous device installed at a target site in a patient. Various methods and procedures may also be provided to releasably engage a supporting structure or supporting device proximate a target site. Apparatus and methods may be provided to monitor performance of an intraosseous device during communication of drugs, medications and/or fluids with an intraosseous space.

1 . Apparatus for supporting an intraosseous device disposed at a target site in a patient comprising: 
 a supporting structure having an opening formed therein;    the opening having a configuration and interior dimensions compatible with exterior portions of the intraosseous device; and    an attachment mechanism operable to releasably engage the supporting structure to a patient proximate a target site.    
     
     
         2 . The apparatus of  claim 1  further comprising the attachment mechanism selected from the group consisting of an elastomeric band, a strap, and a belt.  
     
     
         3 . The apparatus of  claim 1  wherein the attachment mechanism further comprises: 
 the supporting structure having a generally hollow, cylindrical portion sized to receive a portion of the intraosseous device therein;    a strap having a first end and a second end;    a first flap extending from the cylindrical portion and a second flap extending from the cylindrical portion;    an first opening formed in the first flap and a second opening formed in the second flap; and    the first opening and the second opening sized to respectively receive the first end and the second end of the strap therein.    
     
     
         4 . The apparatus of  claim 1  wherein the attachment mechanism further comprises: 
 a strap having a first end and a second end;    a first flap extending from the supporting structure and a second flap extending from the supporting structure;    a first opening formed in the first end of the strap and a second opening formed in proximate the second end of the strap; and    a first projection extending from the first flap;    the first projection sized to be releasably engaged with the first opening of the first end of the strap; and    a second projection extending from the second flap; and    the second opening formed in the second end of the strap sized to releasably receive the second projection.    
     
     
         5 . The apparatus of  claim 1  wherein the attachment mechanism further comprises: 
 a first band sized to be releasably engaged with a patient's limb when the intraosseous device is disposed at a target site in the patient's limb;    a dome attached with the band; and    the dome having an opening formed therein and sized to receive a portion of the intraosseous device therein.    
     
     
         6 . The apparatus of  claim 1  were in the attachment mechanism further comprises: 
 a band sized to be received within sized to be releasably engaged with a patient's limb;    a supporting structure having a generally hollow cylindrical portion sized to receive a portion of the intraosseous device therein;    the band operable to be releasably engaged with a patient's limb; and    a strain gage attached with the band an operable to detect increasing or decreasing the strain placed on the band.    
     
     
         7 . The apparatus of  claim 1  wherein the supporting structure further comprises 
 a generally hollow dome shaped configuration;    the dome shaped configuration having an interior diameter compatible with the exterior diameter of portions of the intraosseous device;    a strap;    the dome shaped structure mounted on the strap;    a target disposed in the dome in the opening of the dome shaped structure; and    the strap operable to be releasably engaged with a patient's limb.    
     
     
         8 . The apparatus of  claim 1  wherein the attachment mechanism further comprises: 
 a band having a first end and a second end;    a first strip of hook and loop type material disposed adjacent to the first end of the band; and a strip of hook and loop type material disposed adjacent to the second end of the band whereby the strip of hook and loop material on the first end of the band maybe releasably engaged with the strip of hook and loop type material approximate the second of the band.    
     
     
         9 . Apparatus for stabilizing an intraosseous device disposed in bone marrow comprising: 
 a supporting structure and a strap;    the strap operable to releasably secure the supporting structure proximate an insertion site for the intraosseous device;    the supporting structure having an opening formed therein and sized to receive at least a potion of the intraosseous device; and    the strap and the supporting structure cooperating with each other to minimize movement of the intraosseous device relative to the insertion site when the portion of the intraosseous device is disposed in the opening of the supporting structure.    
     
     
         10 . The apparatus of  claim 9  further comprising: 
 a sensor attached to the strap; and    the sensor operable to detect parameters associated with providing fluids to the bone marrow through the intraosseous device.    
     
     
         11 . The apparatus of  claim 9  further comprising: 
 the intraosseous device having a tip operable to be disposed in the bone marrow;    a sensor attached with the tip; and    the sensor operable to detect intraosseous pressure of the bone marrow.    
     
     
         12 . The apparatus of  claim 11  further comprising: 
 a wire extending from the intraosseous device to a monitor; and    the monitor operable to indicate the intraosseous pressure.    
     
     
         13 . The apparatus of  claim 9  wherein the opening in the supporting structure comprises a recess sized to receive a penetrator assembly and to guide the penetrator assembly into a selected insertion site in a patent.  
     
     
         14 . A system operable to monitor the performance of an intraosseous device disposed in bone marrow comprising: 
 the intraosseous device having the first end operable to be inserted into the bone marrow;    the intraosseous device having a second end extending from the bone marrow;    the intraosseous device a wire extending through the longitudinal bore of the intraosseous device and engaged with the pressure sensor; and    the wire coupled with a pressure monitor to record intraosseous pressure of the bone marrow.    
     
     
         15 . The system of  claim 14  further comprising: 
 a supporting structure having an opening formed therein;    the opening having a configuration and interior dimensions compatible with exterior dimensions of the intraosseous device; and    an attachment mechanism operable to releasably engage these supporting structure to the patient.    
     
     
         16 . A system for monitoring performance of an intraosseous device disposed in bone marrow in a patient's limb comprising: 
 the intraosseous device having a first end operable to the be disposed within the bone marrow and a second end operable to be connected with tubing;    the tubing operable to communicate fluid between a fluid source and the bone marrow;    a pressure sensor operable to monitor pressure in a compartment of the patient's limb adjacent to the bone marrow; and    the pressure sensor operable to detect any increase in pressure within the compartment of the patient's limb.    
     
     
         17 . The system of  claim 16  further comprising: 
 the fluid source having a control valve; and    the pressure sensor operable to close the control valve when pressure in the compartment sees a preset level.    
     
     
         18 . The system of  claim 16  wherein the pressure sensor further comprises: 
 a hollow needle insert into the compartment;    a hollow tube connecting the hollow needle with a pressure gauge; and    the pressure gauge connected to a pressure monitor.    
     
     
         19 . A method of providing vascular access in a patient's limb comprising: 
 inserting an intraosseous device into bone marrow at a target site in patient's limb;    releasably attaching a supporting structure with the intraosseous device; and    releasably attaching the supporting structure with the patient proximate the injection site.    
     
     
         20 . The method of  claim 19  further comprising 
 monitoring intraosseous pressure within the bone marrow.    
     
     
         21 . The method of  claim 19  further comprising: 
 monitoring tissue pressure in a compartment of the patient's limb approximate the bone marrow; and    alerting medical personnel if the tissue pressure exceeds a preset limit.    
     
     
         22 . The method of  claim 19  further comprising: 
 monitoring intraosseous pressure within the bone marrow;    alerting medical personnel when the intraosseous pressure exceeds a preset limit.    
     
     
         23 . The method of  claim 19  further comprising: 
 attaching the support structure to the patient with a strap having a strain gage operable to detect increases in the size of the patient's limb; and    alerting medical personnel if the increase in the size of the patient's leg exceeds a preset limit.    
     
     
         24 . An apparatus for penetrating a bone and associated bone marrow comprising: 
 a penetrator assembly operable to penetrate the bone and associated bone marrow;    the penetrator assembly including an outer penetrator having a first end and a second end;    the first end of the outer penetrator operable to be inserted in the bone and associated bone marrow;    the outer penetrator having a generally tapered exterior configuration extending between the first end to the second end; and    the exterior configuration of the outer penetrator selected to provide an optimum seal with adjacent portions of the bone.    
     
     
         25 . The apparatus of  claim 24  wherein the penetrator assembly further comprises: 
 an inner penetrator slidably disposed within the outer penetrator; and    the inner penetrator releasably engaged with the outer penetrator.    
     
     
         26 . The apparatus of  claim 24  further comprising: 
 a connector receptacle disposed proximate the second end of the outer penetrator; and    the connector receptacle operable to releasably engage the apparatus with a driver.    
     
     
         27 . The apparatus of  claim 24  further comprising the penetrator assembly operable to be releasably engaged with a powered driver.  
     
     
         28 . The apparatus of  claim 24  further comprising the penetrator assembly operable to be releasably engaged with a manual driver.  
     
     
         29 . An intraosseous device operable to harvest bone marrow comprising: 
 a first end and a second end;    the first end of the intraosseous device operable to penetrate bone and bone marrow;    a longitudinal bore extending between the first end and the second end;    exterior portions of the intraosseous device having a tapered configuration extending from the first end towards the second end;    a layer of sealant disposed on exterior portions of the intraosseous device extending from the first end towards the second end; and    the tapered configuration and the layer of sealant cooperating with each other to substantially reduce or eliminate leakage of any fluid between the exterior of the intraosseous device and adjacent portions of the bone.    
     
     
         30 . The intraosseous device of  claim 29  further comprising the layer of sealant selected from the group consisting of silicone and methyl methacrylate.  
     
     
         31 . An intraosseous device operable to harvest bone marrow comprising: 
 an outer penetrator having a first end and a second end;    the first end of the outer penetrator operable to penetrate bone and bone marrow;    a longitudinal bore extending between the first end and the second end;    exterior portions of the outer penetrator having a generally tapered configuration extending from the first end towards the second end; and    the generally tapered configuration of exterior portions of the outer penetrator operable to form a fluid barrier with adjacent portions of the bone and to substantially reduce or eliminate leakage of fluid between the exterior of the outer penetrator and the adjacent portions of the bone.    
     
     
         32 . An intraosseous device operable to harvest bone marrow comprising: 
 a first end and a second end;    the first end of the intraosseous device operable to penetrate bone and bone marrow;    a longitudinal bore extending between the first end and the second end; and    exterior portions of the outer penetrator having a layer of sealant disposed thereon to substantially reduce or eliminate leakage of any fluid between the exterior portions of the outer penetrator and adjacent portions of the bone.    
     
     
         33 . The intraosseous device of  claim 32  further comprising the sealant selected from the group consisting of silicone and methyl methacrylate.