project advisors david h j wang ph d douglas e smith ph d dennis kopilec marlin h mickle ph d
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University of Pittsburgh Senior Design – BioE 1160. Pressure Sensing Transseptal Cannula for use with TandemHeart ™ PTVA System. Project Advisors: David H.J. Wang, Ph.D. Douglas E. Smith, Ph.D. Dennis Kopilec Marlin H. Mickle, Ph.D.

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project advisors david h j wang ph d douglas e smith ph d dennis kopilec marlin h mickle ph d

University of Pittsburgh

Senior Design – BioE 1160

Pressure Sensing Transseptal Cannula for use with TandemHeart™ PTVA System

Project Advisors:David H.J. Wang, Ph.D.Douglas E. Smith, Ph.D.Dennis KopilecMarlin H. Mickle, Ph.D.

Team Members:Mihoko HashimotoLauren KokaiNitin NarayanaKatie O’Callaghan

February 17, 2004

overview
Overview

Problem:

Unmonitored changes in LA pressure of patients on the TandemHeart™ PTVA System (below a certain pressure threshold) may pose a threat to the patient due to a potential “suck down” of tissue (overdrainage of LA). This causes tissue damage and reduced blood flow.

Solution:

Real time pressure readings in the LA can possibly prevent the tissue “suck down”.

  • Incorporate a pressure sensor into the tip of the Transseptal Cannula along with the use of either RF-technology or wire attachment for signal transmission.
  • Effectively determine an appropriate pump speed depending on patient’s conditions without further invasive processes.
original goals
Original Goals

The ultimate goal is to enable real-time measurements of Left Atrial Pressure (LAP) with TandemHeart use, by placing an absolute pressure sensor chip at the tip of the cannula.

+ Study the feasibility of the incorporation of RF transmitter complex to transmit the real-time measurements without need for wiring.

High Level Timing Goals

  • Analysis of pressure sensor properties & manufacturing limitations
  • Establish that device redesign meets PDS under simulated clinical use conditions
original personal responsibilities
Original Personal Responsibilities

Project Criteria: Milestone 1 (30%) Milestone 2 (30%)

Milestone 3 (10%) Milestone 4 (10%)

Milestone 5 (5%) Milestone 6 (7.5%)

Milestone 7 (7.5%)

updated schedule goals
Updated Schedule / Goals
  • Feasibility
    • Pressure sensor comparison report
    • Summaries of regulatory considerations
  • Preliminary Prototype Design
    • Assemble preliminary prototype  sketch/drawing of cannula redesign
    • Design circuit; assess power source options  circuit diagram
  • Preliminary Prototype Testing
    • Test sensor accuracy for intended range of use
    • Test for quick response time
    • Simulate suction conditions & characterize sensor response
deliverables
Deliverables
  • Pressure sensor comparison chart
  • Summary of regulatory considerations
  • Drawing of preliminary prototype
  • Circuit diagram
  • Test Protocols & Test Reports for all tests conducted on prototype
  • DHF
  • SBIR application
  • 510(k) application?
completed tasks
Completed Tasks
  • Pressure Sensor Product Summary Comparison Chart
  • FDA regulations regarding pressure sensing catheter
    • 21 CFR § 870.2870 – Catheter tip pressure transducer
    • 21 CFR § 870.2850 – Extravascular blood pressure transducer
    • 21 CFR § 870.2060 – Transducer signal amplifier and conditioner
    • 21 CFR § 870.1110 – Blood pressure computer
  • FCC regulations regarding intentional emission of RF
    • “Regulations pertaining to intentional emitters for the purpose of energy harvesting”
    • “Passive E-Field Telemetry: A new wireless transmission principle in minimally Invasive Medicine” Neukomm et al.
    • 47 CFR § 2.1093 – Radio frequency radiation exposure evaluation: portable devices
    • OET Bulletin No.65, Evaluating Compliance with FCC Guidelines for Human Exposure to Radio frequency Electromagnetic Fields
  • EMC (Electromagnetic Compatibility) considerations
    • “Electromagnetic Compatibility in Medical Equipment: A Guide for Designers and Installers” (Kimmel and Gerke)
fcc regulatory summary
FCC Regulatory Summary

The FCC limits the maximum permissible exposure limits for the maximum rate at which energy can be transferred to a square cm of a person’s body over a period of time.

  • For occupational/controlled exposure (100 kHZ – 6 GHz)
    • Average limit for occupational/controlled exposure is 0.4 W/kg over the whole-body and spatial peak specific absorption rate not exceeding 8 W/kg as averaged over any 1 gram of tissue (defined as a tissue volume in the shape of a cube).

(47 CFR § 2.1093)

  • Predicted calculations for RF field strength (PG) and power density adhere to the following equations (single radiating antenna/worst-case prediction):
    • S = PG / πR2 (S = power density; P = power input to antenna; G = power gain of antenna; R = distance to the center of radiation)
further information needed re rf
Further Information Needed Re: RF
  • Identify RF transmitter supplier
  • Determine sampling frequency (.1 – 2 Hz)
  • Determine required signal strength for signal transmission through chest cavity
project successes to date
Project Successes to Date
  • Identified fiber optics pressure transducer (FISO FOP-MIV) and contacted company for sample
  • Comparison evaluation of several other possible pressure sensors
  • Obtained Motorola chip and transducer testing circuit
  • Progress on regulatory considerations (FCC, FDA, EMF)
  • Updated DHF documents
wrenches in the works
Wrenches in the Works
  • Communication: slow response from companies regarding system elements
  • Budget
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