1. Blood Salvage Compatible Suction Canister
University of Pittsburgh
Senior Design – BioE 1160/1161
Blood Salvage Compatible Suction Canister
Andres Correa
Adam Iddriss
Brandon Williams
April 18, 2006
Mentors:
Jonathan Waters, MD
Marina Kameneva, PhD
Good Afternoon distinguished ladies and gentleman, professor gartner, and my fellow classmates. My name is Brandon Williams and my partners are Andres Correa and Adam Iddriss. Our senior design project focused on the redesign of a blood salvage compatible suction canister. Our mentors were Dr Jonathan Waters , Chief of Anesthesiology at Magee womens hospital and Dr. Marina Kameneva from McGowen institute of regenerative medicine.

2. 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
I would know like to briefly introduce you to some of the complications that occur associated with surgeries and typical blood transfusions. At Magee Womens hospital unexpected blood loss occurs in approximately 1 in every 70 surgeries. This unexpected blood loss calls for blood to be transfused to the patient from donor blood under current methods. However, the use of donor blood has its drawbacks. Firstly, only 5% of eligible donors are making donations in the United States and also the cost of blood typing and screening is approximately $300/unit. Where as a unit of blood is 450ml. There is also an inherent risk for the infection of disease. Currently 1 in every 10,000 transfusions infects the patient with hepatitis C and 1 in every 676,000 infect the patient with HIV. The combination of these facts has lead to the development of alternative in blood management.

3. 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 patient’s 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
Currently there are two main methods of blood transfusions practiced in the united states. They are allogeneic and autologous transfusions. The combination of both allogeneic and autologous transfusions generated a 1.3 billion dollar industry in the US.
Allogeneic transfusions refer to those transfusions in which donor blood is given to the patients, contrasting this method is autologous transfusions where the patient is reinfused with their own erythrocytes
Autologous transfusions have emerged as a viable alternative to allogeneic transfusions for several reasons. They decrease immunomodulation, the body’s immune response to a foreign substance. They prevent the transmission of viral diseases. Decrease transfusions reactions associated with allogeneic transfusions, and due to religious beliefs. Jehovia Witness’s do not believe in receiving donor blood and will refuse it during surgery.

4. Cell Salvage Continued
Blood typically discarded as waste

5. Cell Salvage Continued
Blood salvaged

6. 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

7. 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

8. 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

9. 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)

10. Redesigned Suction Canister
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

11. Prototype Development
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

12. Prototype Development
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

13. Prototype Development
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

14. Prototype Fabrication+ +
Poly(ethylene) sheet
Drill pressed liner
Stainless steel washer + +
Adhesive
SLA Puncture Apparatus
Prototype

15. Rubber stopper for disposal Modified liner with membrane
Finalized Prototype + +
Rubber stopper for disposal
Puncture Apparatus
Modified liner with membrane

16. Experimental Methods
Testing of two cell salvage compatible suction canisters for:
Membrane Strength
Membrane Penetrability
Leakage of fluid from the closed system
During our testing phase we decided to focus on the functionality of our device rather than the viability of blood collected by the device, which is to be determined by the anestiologist.
We concentrated on the membrane strength, membrane penetrability, and leakage of fluid form the closed system

17. 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
During our testing we were unable to obtain pictures and could not set up another testing date in the OR. So I will briefly demonstrate each step of the testing to you.

18. 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
During our testing we encountered one minor complication. A residual volume of saline was observed in the canister upon extraction. This problem led us to consider a device to seal the canister upon the extraction of fluid. We originally considered 2 different methods.

19. 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
Our testing showed us several things. Which included:

20. 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)

21. 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

22. Competitive Analysis Strengths Weakness
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

23. 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

24. FDA Regulation TITLE 21--FOOD AND DRUGS
CHAPTER I—FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
Subpart G--General Hospital and Personal Use Miscellaneous Devices
Sec 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:

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

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

27. Questions?

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