Project Title: Variable Stiffness Guidewire for catheters

Client: Dr. Victor Houghton

Team Members: Kristi Hinner, Jeremy O’Brien, Brian Asti, John Puccinelli, Tom Pearce, Erik Birkeneder, Hart Moss, Nick Vandehey

Small Group Members: John Puccinelli, Hart Moss

Date: 10/3/01 – 10/9/01

Problem Statement: To design a guide wire of variable stiffness to be used in a catheterization procedure and in situations where the conventional guide wires fail that is when attempting to maneuver around a turn of 100 to 140degres. The wire must be of correct stiffness (soft) in order to reach the correct point in the vessel, but also provide enough force (stiff) for the catheter to follow into the vessel.

Restatement of Team Goals:

1. Meet with individual group-set up a weekly meeting time outside of class

2. Begin brainstorming ideas as individual groups

3. Develop ideas

4. Begin formulating the midsemester paper in rough form

Summary of Accomplishments:

Researched the area of catheters and guide wires for background information

Formulated ideas:

Heat sensitive device

Fluid hardness

Bead (stack of books theory)

Hydraulics

Torsion

Statement of Team Goals:

1. Finish midsemester paper and presentation

2. Develop ideas further

Project Schedule:

Week 1 (9/7- 9/11): Choose projects and form design teams; choose partners and team roles; contact client and set up client meeting.

Week 2 (9/12- 9/18): Meet with client; discuss PDS with group; begin first design steps with in pairs.

Week 3 (9/19 - 9/25): Meet with client, discuss PDS with group. Background information on project; brainstorming; work on PDS.

Week 4 (9/26 - 10/2): Brainstorming; design ideas; begin working on presentation; PDS.

Week 5 (10/3 - 10/9): Work on presentations; PDS.

Week 6 (10/15 - 10/16): Finish final paper and presentation

OCTOBER 19 - MIDSEMESTER PRESENTATIONS

Week 7 (10/17 - 10/23):

Week 8 (10/24 - 10/30):

Week 9 (10/31 - 11/6):

Week 10 (11/7 – 11/13):

Week 11 (11/14 – 11/20):

Week 12 (11/21 – 11/27):

Week 13 (11/28 – 12/4):

Week 14 (12/5 – 12/11):

Difficulties: Time constraints with Twin Cities industry tour this weekend, and exams the past week

Activities:

This week:

John – Research – 1hour

Formulating paper – 3hours

Hart – Research – 2hours

Paper – 2hours

PDS BELOW

Variable Stiffness Guidewire- PDS

Group Members: Kristi Hinner, Jeremy O’Brien, Brian Asti, Tom Pearce, Erik Birkeneder, Hart Moss, Nick Vandehey, John Puccinelli

Function: A catheter guidewire of variable stiffness to be used in a cerebral catheterization procedure and in situations where the conventional guidewires fail. The wire must be flexible enough to reach the correct point in the vessel, but stiff enough to provide stability for the catheter to follow into the vessel.

Client Requirements:

· 10-20 cm of variable stiffness between flexible tip and stiff remaining wire.

· Wire diameter of 0.97 mm.

· Guide around turns angles of 100-140° in vessels.

Design requirements:

1. Physical and Operational Characteristics

a. Performance requirements:

· Single-use.

· Change rigidity from flexible to stiff.

· Conform to existing guidewire standards.

b. Safety:

· Non-hazardous biomaterials.

· Cannot change the environment of its surroundings (e.g. temperature, size).

c. Accuracy and Reliability:

· Must maneuver through desired vessel turns effectively.

· Withstand internal conditions of human body.

d. Life in Service:

· Withstand one catheterization.

e. Shelf Life:

· 10-yr life expectancy.

f. Operating Environment:

· Blood vessels of human body.

g. Ergonomics:

· 0.97 mm in diameter

· Physician-friendly.

h. Size:

· Total length of 150 cm.

· Tip length of 3 cm.

· 10-20 cm of variable stiffness.

i. Weight:

· Cannot alter normal functions.

j. Materials:

· Stainless steel or similar material for inner portion of wire.

· Hypoallergenic, hydrophilic coating.

k. Aesthetics, Appearance, and Finish:

· Similar to existing guidewires.

2. Production Characteristics

a. Quantity:

· One.

b. Target Product Cost:

3. Miscellaneous

a. Standards and Specifications:

· Must be FDA approved.

b. Customer:

c. Patient-related concerns:

d. Competition:

· One such guidewire currently undergoing research at Cook, Inc.