Ideation Process Innovation Situation Questionnaire 1. Brief description of the problem design needle that injects and withdraws simultaneously 2. Information about the system 2.1 System name intravenous needle 2.2 System structure needle with 2 main lumen and 2 auxilliary lumen for sensor insertion 2.3 Functioning of the system needle will allow withdrawing of undiluted blood sample with continuous injection of IV fluid 2.4 System environment vein interior 3. Information about the problem situation 3.1 Problem that should be resolved prevent multiple needle sticks for blood withdraw reduce waste of excessive needle usage 3.2 Mechanism causing the problem necessity of repeated blood sampling during IV injection 3.3 Undesired consequences of unresolved problem health risk to workers being pricked by infected needle 3.4 History of the problem Appendix 1 Doctors need to make continuous injection of IV fluid to patients, while also making frequent blood measurements. This requires the use of a IV needle and the use of a separate needle(s) to make blood withdraw 3.5 Other systems in which a similar problem exists fluid tanks 3.6 Other problems to be solved allow optical sensors to be embedded in the needle body 4. Ideal vision of solution single needle with special head that allows selective control of pressure in one of two primary lumen. This needle will have side-embedded optical sensors for these measurements 5. Available resources computational flow dynamics software - Dr. Roselli physical test system - Dr. Giorgio 6. Allowable changes to the system distance from tip of needle to opening of secondary lumen length of needle materials for needle design stoppable IV injection 7. Criteria for selecting solution concepts cost of design comfort ease of use 8. Company business environment financial: limited funds ($300) human: three undergraduate engineers, 3 professional engineers 9. Project data Appendix 2 NAME: MedTG Needle Design OBJECTIVES: design needle capable of fluid injection and blood withdraw, as well as making optical measurements TIMELINE: December: Computational modeling, select initial design parameters Literature review, incorporate into model January: Continue computational modeling with chosen parameters Begin construction and validation of physical test system Create preliminary needle design, evaluate Adjust necessary test parameters and needle parameters February - March: Computational adjustment Physical design incorporation of computational information Continue testing April: Finish design Prepare presentation Problem Formulation 1. Build the Diagram Appendix 3 2. Directions for Innovation 12/4/2003 5:26:42 PM Diagram1 1. Find a way to eliminate, reduce, or prevent [the] (People dislike being stuck with needle) in order to avoid [the] (People are uncooperative with multiple sticks), under the conditions of [the] (Must stick patient to obtain sample). 2. Find a way to eliminate, reduce, or prevent [the] (People are uncooperative with multiple sticks) in order to avoid [the] (Physician fails his job), under the conditions of [the] (People dislike being stuck with needle). 3. Find a way to eliminate, reduce, or prevent [the] (Physician fails his job) under the conditions of [the] (People are uncooperative with multiple sticks) and (Health hazard due to excessive use and waste). 4. Find an alternative way to obtain [the] (Physician needs multiple blood samples) that offers the following: does not cause [the] (Must stick patient to obtain sample), does not require [the] (Physician must monitor blood during IV injection). 5. Try to resolve the following contradiction: The useful factor [the] (Physician needs multiple blood samples) should be in place in order to fulfill useful purpose and should not exist in order to avoid [the] (Must stick patient to obtain sample). 6. Find a way to eliminate, reduce, or prevent [the] (Must stick patient to obtain sample) in order to avoid [the] (People dislike being stuck with needle) and (Multiple needles used), under the conditions of [the] (Physician needs multiple blood samples). 7. Find an alternative way to obtain [the] (Physician must monitor blood during IV injection) that provides or enhances [the] (Physician needs multiple blood samples). 8. Find a way to eliminate, reduce, or prevent [the] (Multiple needles used) in order to avoid [the] (Health hazard due to excessive use and waste), under the conditions of [the] (Must stick patient to obtain sample). 9. Find a way to eliminate, reduce, or prevent [the] (Health hazard due to excessive use and waste) in order to avoid [the] (Physician fails his job), under the conditions of [the] (Multiple needles used). Prioritize Directions 1. Directions selected for further consideration 4. Find an alternative way to obtain [the] (Physician needs multiple blood samples) that offers the following: does not cause [the] (Must stick patient to obtain sample), does not require [the] (Physician must monitor blood during IV injection). 6. Find a way to eliminate, reduce, or prevent [the] (Must stick patient to obtain sample) in order to avoid [the] (People dislike being stuck with needle) and (Multiple needles used), under the conditions of [the] (Physician needs multiple blood samples). Appendix 4 7. Find an alternative way to obtain [the] (Physician must monitor blood during IV injection) that provides or enhances [the] (Physician needs multiple blood samples). 2. List and categorize all preliminary ideas instead of combined needle, design IV complementary system for obtaining blood sample without needle stick · Develop Concepts 1. Combine ideas into Concepts IDEAS: Obtain blood sample using catheter that is already injected for IV administration by turning off IV administration temporarily Keep separate blood draw catheter in site upstream or isolated from site of IV administration catheter COMPARISON: Both allow a limited number of initial needle sticks to solve the same problem Using just one catheter is physically superior but non-ideal because IV should not be shut off ideally Separate cathers is functionally superior but non-ideal because two catheters must be used COMBINATION: Recipient: one catheter system, derive functional improvement from source idea Source: two catheter system Recipient needs to incorporate element of separate lumen to improve functionality, design one catheter with multiple lumen Can design bilumen catheter without increasing overall size of catheter by adjusting shape of secondary lumen to "wrap" around the primary lumen RECIPIENT DESIGN: will be of similar size to original single catheter but be manufactured to have two lumen of optimized size and geometry 2. Apply Lines of Evolution to further improve Concepts must find way to manufacture a catheter with varying sizes and orientations must decide on suitable material Appendix 5 must decide on a distance to separate lumen exits Evaluate Results 1. Meet criteria for evaluating Concepts The criteria have been met thus far. We've been able to define several x-distances between a variety of lumen sizes as well as the parameters within which these xdistances function. 2. Reveal and prevent potential failures The main concept is a double lumen needle that is able to continously deliver IV fluid while drawing blood. The idea scenario for this concept is to develop a needle with two lumens spaced as close together yet still able to draw uncontaminated blood samples from the more distal lumen. If the distal lumen was unable to draw uncontaminated blood the concept would be a failure. It should be possible to eliminate the failure of a contaminated blood draw by developing a rigorous design that functions at a variety of parameters. 3. Plan the implementation The implementation phase consisted of doing both computational and physical models in order to figure out which x-distances would work under what parameters. Both sets of models tested a variety of blood draw rates, x-distances, and lumen sizes to determine which were effective combinations. Appendix 6