Blood Salvage Compatible Suction Canister

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Blood Salvage Compatible Suction Canister
University of Pittsburgh Senior Design BioE
1160/1161
Andres Correa Adam Iddriss Brandon
Williams April 18, 2006 Mentors Jonathan
Waters, MD Marina Kameneva, PhD
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Unexpected Blood Loss

• Unexpected blood loss occurs in approximately
  1/70 surgeries (Magee Hospital)
• Challenges of blood transfusions
• 5 of eligible donors making donations
• costs of blood typing and screening (300/unit)
• Risk of disease transmission
• 1/10,000 for Hepatitis C
• 1/676,000 for HIV
• This has led to the development of alternatives
  in blood management

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Cell Salvage

• Allogeneic and autologous blood transfusions
  generate 1.3 billion in US
• Allogeneic transfusions involve the infusion of
  blood from a donor
• Autologous transfusions involve the re-infusion
  of the patients own erythrocytes
• Autologous transfusions have emerged as a viable
  alternative to allogeneic transfusions
• decrease immunomodulation
• prevent transmission of viral diseases
• decrease transfusion reactions associated with
  the more traditional technique
• religious beliefs

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Cell Salvage Continued
Blood typically discarded as waste
http//www.haemonetics.com/site/flash/cell_saver.h
tml
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Cell Salvage Continued
Blood salvaged
http//www.haemonetics.com/site/flash/cell_saver.h
tml
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Suction Canisters

• Suction canisters are plastic containers used
  during irrigation to remove excess fluids from
  patients and provide a clear surgical site for
  operations
• US market 94 million
• Annual growth rate of 0.4
• Unit cost 1.22
• Market distribution
• Allegiance 58
• Abbott 20
• Bemis 15

Frost Sullivan, 2003
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Problem Statement

• Current methods of blood management do not
  adequately meet transfusion needs
• 12-14 million blood transfusions annually in the
  US
• Increased need for blood (38,000 units /day)
• Lack of donations
• High cost of blood management
• Risks of transfusion

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Our Project

• Redesign suction canister liner to incorporate
  the use of a cell salvage system
• Decrease the dependency on donated blood
• Increase patient confidence
• Improve safety
• Provide a cost-effective means of transfusing
  patients in emergency situations

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Design Requirements

• Perform as a typical suction canister
• Leak-proof
• Transparent for visual blood inspection
• Viable under closed suction system
• Collection, retention, and disposal standards
• Easy connection to cell salvage system
• Injection port for heparin delivery
• Sterile
• Economical (4.00)

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Proposed Solution

• Redesigned Suction Canister
• Must have membrane capable of withstanding vacuum
  pressure of at least 200 mmHg
• Membrane must be penetrable by a simple device
• Puncture device must be able to connect to cell
  salvage vacuum tubing
• Must be able to have heparin introduced to the
  blood volume

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Prototype Development
Prototype 1.1

• Complicated design due to the need for a membrane
  valve
• Re-modification of vacuum canister housing
• Decreased blood volume due to reduction in size
  of canister

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Prototype Development
Prototype 1.2

• Better design than Prototype 1.1 due to stopcock
  valve to prevent flow
• Re-modification of vacuum canister housing
• Decrease collected blood volume due to reduction
  in size of canister

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Prototype Development
Prototype 2.0

• Polyethylene membrane capable of withstanding
  vacuum pressure of
• 200 mmHg
• Membrane penetrable by puncture apparatus
• Best design due to no need for vacuum canister
  housing modification and original canister volume
  is maintained

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Prototype Fabrication


Poly(ethylene) sheet
Drill pressed liner
Stainless steel washer


Adhesive
SLA Puncture Apparatus
Prototype
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Finalized Prototype


Rubber stopper for disposal
Puncture Apparatus
Modified liner with membrane
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Experimental Methods

• Testing of two cell salvage compatible suction
  canisters for
• Membrane Strength
• Membrane Penetrability
• Leakage of fluid from the closed system

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Experimental Methods

• Testing
• Canister was connected to Cobe Brat II and vacuum
  pressure was placed at maximum pressure (200
  mmHg)
• Membrane was observed to make sure it withstood
  pressure
• 1000cc of saline was suctioned into the cell
  salvage compatible canister at vacuum pressure of
  200 mmHg
• Canister was removed from its housing (membrane
  withheld)
• Membrane was penetrated by puncture apparatus and
  no observed leaking of saline occurred
• The saline was then vacuumed to the cell salvage
  filter

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Experimental Methods

• Complications During Testing
• A residual volume of saline was observed in the
  cell salvage canister upon extraction
• This problem led us to consider a device to seal
  the canister upon
• extraction of fluid
• Model a device similar to our puncture apparatus
  that does not have a hollow tube and ends at the
  circular washer
• 6 mm rubber stopper plug

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Discussion

• Our testing showed
• The polyethylene membrane withstood 200 mmHg
• No leaks were present during the suction of the
  saline
• Need for a device to prevent leakage of residual
  volume

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Economic Considerations

• Cost analysis
• 1 unit of blood 300
• Average suction canister 1.22
• Modified suction canister 4.00
• Drainage hole and polyethylene covering membrane
• 2,500 for membrane and hole tooling
• .15 for membrane incorporation
• Puncturing device
• 10,000 for injection molding mold
• 0.10 per puncturing device
• Sterilization
• Plasma sterilization 2 per canister
• Proportion of unexpected blood loss 1/70
  surgeries
• (Magee Womens Hospital)

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Economic Feasibility

• Price spent on current canisters
• 1.22/canister x 70 canisters/day x 365 days/year
  31,171/year on canisters
• Price spent on re-designed canisters
• 4.00/canister x 70 canisters/day x 365 days/year
  102,200/year on canisters
• Assume a minimum of 1 unit of blood is lost per
  70 surgeries
• 300/unit of blood 365 days/year
  109,500/year on blood
• 70/ cell salvage 365 days/year 25,550/ year
  on cell salvage
• Summation of canister cost and blood cost
• 109,500/year 31,171/year (102,200/year
  25,550/ year) 12,921 saved per year assuming
  only 1 unit of blood is salvaged every 70
  surgeries
• Data from Magee Hospital extrapolated to national
  level
• 12,921/year x 5,794 hospitals in the US 75
  million annually

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Competitive Analysis

• Strengths
• Compatible with the cell salvage system
• The potential to save the hospital money
• Reduces complications associated with allogeneic
  blood transfusions
• Weakness
• The modified canister is more expensive
• There is a chance for blood leakage and
  contamination of the OR environment due to the
  blood transfer to the cell salvage system

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Constraints Limiting Phase I Testing

• Economic
• 500 budget from the bioengineering department
• Cost of sterilization
• Biocompatibility testing
• Cytotoxicity
• Thrombi formation analysis
• Regulatory
• Institutional Review Board (IRB) for human
  clinical testing
• Blood-borne pathogens regulations

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FDA Regulation

• TITLE 21--FOOD AND DRUGS
• CHAPTER IFOOD AND DRUG ADMINISTRATION
  DEPARTMENT OF HEALTH AND HUMAN SERVICES
• SUBCHAPTER H--MEDICAL DEVICES
• Subpart G--General Hospital and Personal Use
  Miscellaneous Devices
• Sec. 880.6740 Vacuum-powered body fluid suction
  apparatus. .
• (a) Identification. A vacuum-powered body fluid
  suction apparatus is a device used to aspirate,
  remove, or sample body fluids. The device is
  powered by an external source of vacuum. This
  generic type of device includes vacuum
  regulators, vacuum collection bottles, suction
  catheters and tips, connecting flexible
  aspirating tubes, rigid suction tips, specimen
  traps, noninvasive tubing, and suction regulators
  (with gauge).
• (b) Classification. Class II (performance
  standards).
• US Food and Drug Administration
  http//www.accessdata.fda.gov/scripts/cdrh/cfdocs/
  cfcfr/CFRSearch.cfm?FR870.2700

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Project Distribution
Andres Adam Brandon
Fault Tree Initial Hazard Analysis FMEA
PDS Ordering Materials SolidWorks Model
Contacting companies Product manufacturing Product Testing
SolidWorks Model Competition Entry Human Factors Analysis
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Acknowledgements

• Dr. Jonathan Waters
• Dr. Marina Kameneva
• Mark Gartner
• Department of Bioengineering
• Department of Chemistry
• Pittsburgh Life Sciences Greenhouse
• Drs. Hal Wrigley Linda Baker

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Questions?
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Blood Viability
Collection Type Storage Temperature Expiration Special Conditions
Acute nomovolemic hemodilution (whole blood) Room temperature 8 hours from start of collection None
Acute nomovolemic hemodilution (whole blood) 1-6 C 24 hours from start of collection Storage at 1-6 C shall begin within 8 hours of start of collection
Intraopeerative blood recovered with processing Room temperature 4 hours from completion of processing None
Intraopeerative blood recovered with processing 1-6 C 24 hours from start of collection Storage at 1-6 C shall begin within 8 hours of start of collection
American Association of Blood Banks Annual Report
(2005)