Redesign of an Intraosseous Needle University of Pittsburgh Senior Design – BioE 1160/1161 Jonathan Hughes Michael Audette Christopher Sullivan April 18, 2006 Mentor: James Menegazzi, Ph.D.

The Intraosseous Needle Intraosseous (IO) needle Access to venous system via IO pathway Components Needle (14-16 gauge) Trocar Plastic housing Insertion Technique Placed through cortex Fluid delivery to marrow Driven by hand, spring, or drill action Cook Critical Care, Inc. 2000

IO Access Major IO Infusion Sites Pediatric Proximal tibia (1-5 yrs.) Adult Sternum Tibia (proximal or distal) Alternate sites Iliac crest Distal shaft of the femur Jamshidi IO needle

Proximal Tibia Infusion

IO Applications Emergency medicine Limited access to venous system Severe burns, trauma, hypovolemic shock, etc. Fluid and pharmacological resuscitation Bolus infusion (rapid delivery) Continuous infusion Supplemental therapy Marrow sampling Clinical settings

Problem Statement Problem: Insertion technique and location may result in IO needle occlusion Requires reinsertion 15 gauge IO needle redesign: Facilitate infusion by providing alternate flow paths Addition of distal side ports Maintain mechanical strength of needle Occluded IO Insertion

Competitive Analysis Competitors Manual insertion Cook Jamshidi Mechanical insertion EZ-IO (VidaCare) Bone Injection Gun (WaisMed) Strengths Allows the provider to continue to deliver drugs in the event of needle end occlusion The manual needle, which is our focus, can be used multiple times while spring-loaded devices (i.e., Bone Injection Gun) can only be used once Weaknesses With the use of the automatic injection devices, occlusion is not a major problem, although it still happens (~2%)

FDA Regulation Code of Federal Regulations TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 880 – GENERAL HOSPITAL AND PERSONAL USE DEVICES Subpart F--General Hospital and Personal Use Therapeutic Devices Sec Hypodermic single lumen needle. (a) Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set. Class II(b) Classification. Class II (performance standards). US Food and Drug Administration:

Project Goals Redesign a manual 15 gauge intraosseous needle that will allow for continued flow in case of needle tip occlusion (through the addition of distal sideports) Specific goals Maintain mechanical stability of the IO needle - CosmosWorks and In vitro testing If properly inserted, our IO needle should have the same functionality as current IO needles Capable of delivering 200 cc/min of fluids If not properly inserted (tip occlusion), our IO needle should still allow for the delivery of meds through the sideports This additional functionality is not present in current IO needles Minimize extravasation Sideports cannot be too far distal - lead to extravasation during occluded infusion Sideports cannot be too proximal - lead to extravasation during normal infusion

Basic Project Timeline

Design Selection Tree Addition of Sideports One set of sideportsTwo sets of sideports 3+ sets of sideports, 2+ sets of long sideports CircularElongatedInlineOffset Model AModel CModel BModel D How many sideports to add and where?

FEA Testing Finite Element Analysis testing was done in Solidworks and Floworks Scenarios to model: Normal infusion Occluded infusion (simulated with ideal wall at tip) Compare models to each other without the need for costly prototype iterations Allowed for design parameters to easily be changed and retested

Normal Infusion Flow TrajectoriesIn-hole Cut Plot Locations In normal infusion, ~99% of the flow leaves through the tip (essentially no flow through sideports) Therefore, during normal infusion, our needle designs function the same as current IO needles 75 velocity flow trajectories, none leave through the sideports Velocity Profile Cutplot (red = higher v)

Occluded Functionality – One sideport – Model A Heavy backflow (15-20% of overall flow) High flow velocities out of sideports – could possibly result in hemolysis Models B and D have more desirable flow patterns Eliminated 75 flow trajectories (velocity) Velocity Profile Cutplot (red = higher v)

Model A Flow Trajectory Video

Occluded – One sideport – Model C Light backflow Flow profile is similar to Models B and D Eliminated because Models B and D yield similar results, but are cheaper to manufacture Velocity Profile Cutplots (red = higher v) 75 flow trajectories (velocity)

Occluded – Two sideports – Model B Light backflow (2-3%) ~60% of flow out of distal sideport, ~40% out of proximal sideport Essentially all flow has left the needle by the end of the most distal sideport Prototyped 75 flow trajectories (velocity) Velocity Profile Cutplots (red = higher v)

Model B Flow Trajectory Video

Occluded – Two sideports – Model D Light backflow (2-3%) Very similar flow profile to Model B Essentially all flow has left the needle by the end of the most distal sideport Could be prototyped and compared to Model B (future work) 75 flow trajectories (velocity) Velocity Profile Cutplots (red = higher v)

Model D Flow Trajectory Video

Prototype Two prototypes of Model B were produced Manufactured by Vitaneedle out of 316 Stainless Steel 316 Stainless steel is the material used in current needles A Luer Lock hub was attached to the proximal end The device was modeled to make use of the current Jamshidi needle holder for testing purposes since PIM was not feasible

Constraints limiting testing Our trocar did not fit properly into the lumen of the needle prototype Modification of the trocar without compromising tip occlusion was not possible As a result, direct insertion of our prototype into bone was not feasible To compensate, a pilot hole using a current needle was first drilled and then our needle was inserted Our planned in vitro mechanical stability testing was not possible However, our trocarless hollow needle was hammered into bone to model total tip occlusion and showed no mechanical deformation when removed

Experimental Methods Flow Rate Determination Time (in seconds) elapsed to infuse 200 mL of 0.9% saline solution was measured Steady pressure drop of 275 mm Hg to 300 mm Hg maintained by a pressure infusion bag Five cases: Current Jamshidi IO needle (no sideports) without occlusion Current Jamshidi IO needle with occlusion Redesigned IO needle without occlusion Redesigned IO needle with occlusion from rubber stopcock Redesigned IO needle with simulated occlusion in distal end of porcine tibia bone cortex 10 Trials of each case

In-Vitro Testing

In-Vitro Testing II

In-Vitro Testing III

Results Case Mean Time (s) S.D. for Time Mean Flow Rate (cc/min) S.D. for Flow Rate Normal Jamshidi IO needle (no sideports, no occlusion) Normal Jamshidi IO needle with tip occlusion --0- Non-occluded IO needle with sideports IO needle with sideports; tip occluded by rubber stopcock IO needle with sideports; simulated occlusion in porcine tibia

Discussion of Results Over 10 trials, our redesigned IO needle was able to deliver ~300 cc/min of fluid in the event of both cases of tip occlusion Very similar to non-occluded cases 300 cc/min more than adequately satisfies our baseline goal of 200 cc/min Therefore, there appeared to be virtually no difference in infusion time of 200 mL of fluid Obviously, when the tip is occluded in the current IO needle (without sideports), flow is blocked, and there is no path for infusion In the case of the non-occluded needle with sideports, we noticed that all flow passed through the open end even with the sideport openings Minimal Extravasation

Testing (con’t) Dr. Menegazzi used our prototype in testing a deceased porcine test subject The result was that there happened to be needle tip occlusion inadvertently, but aspiration still took place This shows that the sideports provided an alternate path for fluid flow

Human Factors Device does not require the device user population to be highly skilled in needle operation techniques Training with device will consist of the formal training that is standard to normal intraosseous needle use Familiarization of users with the slight differences between the new design and current products of which the users already have experience using Device will be used in the field in emergency care and thus may be used in any location Hospitals Stationary and or Moving Vehicles (i.e., ambulances)

Member Responsibilities JonChrisMike Literature Searches Initial Model Design Fault Tree Floworks Analysis Cosmosworks Analysis IHA FMEA PDS Prototyping In Vitro Testing Results

Acknowledgements James Menegazzi, PhD Steven Abramowitch, PhD VitaNeedle University of Pittsburgh Department of Bioengineering Generous donation from Drs. Hal Wrigley & Linda Baker Mark Gartner

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