Presentation on theme: "Blood Salvage Compatible Suction Canister"— Presentation transcript:
1Blood Salvage Compatible Suction Canister University of PittsburghSenior Design – BioE 1160/1161Blood Salvage Compatible Suction CanisterAndres CorreaAdam IddrissBrandon WilliamsApril 18, 2006Mentors:Jonathan Waters, MDMarina Kameneva, PhDGood 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.
2Unexpected Blood LossUnexpected blood loss occurs in approximately 1/70 surgeries (Magee Hospital)Challenges of blood transfusions5% of eligible donors making donationscosts of blood typing and screening ($300/unit)Risk of disease transmission:1/10,000 for Hepatitis C1/676,000 for HIVThis has led to the development of alternatives in blood managementI 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.
3Cell SalvageAllogeneic and autologous blood transfusions generate $1.3 billion in USAllogeneic transfusions involve the infusion of blood from a donorAutologous transfusions involve the re-infusion of the patient’s own erythrocytesAutologous transfusions have emerged as a viable alternative to allogeneic transfusionsdecrease immunomodulationprevent transmission of viral diseasesdecrease transfusion reactions associated with the more traditional techniquereligious beliefsCurrently 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 erythrocytesAutologous 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.
4Cell Salvage Continued Blood typically discarded as waste
6Suction CanistersSuction canisters are plastic containers used during irrigation to remove excess fluids from patients and provide a clear surgical site for operationsUS market = $94 millionAnnual growth rate of 0.4%Unit cost $1.22Market distribution:Allegiance 58%Abbott 20%Bemis 15%Frost & Sullivan, 2003
7Problem StatementCurrent methods of blood management do not adequately meet transfusion needs12-14 million blood transfusions annually in the USIncreased need for blood (38,000 units /day)Lack of donationsHigh cost of blood managementRisks of transfusion
8Our ProjectRedesign suction canister liner to incorporate the use of a cell salvage systemDecrease the dependency on donated bloodIncrease patient confidenceImprove safetyProvide a cost-effective means of transfusing patients in emergency situations
9Design Requirements Perform as a typical suction canister Leak-proof Transparent for visual blood inspectionViable under closed suction systemCollection, retention, and disposal standardsEasy connection to cell salvage systemInjection port for heparin deliverySterileEconomical ($4.00)
10Redesigned Suction Canister Proposed SolutionRedesigned Suction CanisterMust have membrane capable of withstanding vacuum pressure of at least 200 mmHgMembrane must be penetrable by a simple devicePuncture device must be able to connect to cell salvage vacuum tubingMust be able to have heparin introduced to the blood volume
11Prototype Development Complicated design due to the need for a membrane valveRe-modification of vacuum canister housingDecreased blood volume due to reduction in size of canister
12Prototype Development Better design than Prototype 1.1 due to stopcock valve to prevent flowRe-modification of vacuum canister housingDecrease collected blood volume due to reduction in size of canister
13Prototype Development Polyethylene membrane capable of withstanding vacuum pressure of200 mmHgMembrane penetrable by puncture apparatusBest design due to no need for vacuum canister housing modification and original canister volume is maintained
15Rubber stopper for disposal Modified liner with membrane Finalized Prototype++Rubber stopper for disposalPuncture ApparatusModified liner with membrane
16Experimental MethodsTesting of two cell salvage compatible suction canisters for:Membrane StrengthMembrane PenetrabilityLeakage of fluid from the closed systemDuring 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
17Experimental 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 pressure1000cc of saline was suctioned into the cell salvage compatible canister at vacuum pressure of 200 mmHgCanister was removed from its housing (membrane withheld)Membrane was penetrated by puncture apparatus and no observed leaking of saline occurredThe saline was then vacuumed to the cell salvage filterDuring 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.
18Experimental Methods Complications During Testing: A residual volume of saline was observed in the cell salvage canister upon extractionThis problem led us to consider a device to seal the canister uponextraction of fluid:Model a device similar to our puncture apparatus that does not have a hollow tube and ends at the circular washer6 mm rubber stopper plugDuring 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.
19Discussion Our testing showed: The polyethylene membrane withstood 200 mmHgNo leaks were present during the suction of the salineNeed for a device to prevent leakage of residual volumeOur testing showed us several things. Which included:
20Economic Considerations Cost analysis:1 unit of blood = $300Average suction canister = $1.22Modified suction canister = $4.00Drainage hole and polyethylene covering membrane~$2,500 for membrane and hole tooling~$.15 for membrane incorporationPuncturing device~$10,000 for injection molding mold~$0.10 per puncturing deviceSterilizationPlasma sterilization ~ $2 per canisterProportion of unexpected blood loss = 1/70 surgeries(Magee Womens’ Hospital)
21Economic Feasibility Price spent on current canisters: $1.22/canister x 70 canisters/day x 365 days/year = $31,171/year on canistersPrice spent on re-designed canisters:$4.00/canister x 70 canisters/day x 365 days/year = $102,200/year on canistersAssume 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 salvageSummation 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 surgeriesData from Magee Hospital extrapolated to national level$12,921/year x 5,794 hospitals in the US ~ $75 million annually
22Competitive Analysis Strengths Weakness Compatible with the cell salvage systemThe potential to save the hospital moneyReduces complications associated with allogeneic blood transfusionsWeaknessThe modified canister is more expensiveThere is a chance for blood leakage and contamination of the OR environment due to the blood transfer to the cell salvage system
23Constraints Limiting Phase I Testing Economic$500 budget from the bioengineering departmentCost of sterilizationBiocompatibility testingCytotoxicityThrombi formation analysisRegulatoryInstitutional Review Board (IRB) for human clinical testingBlood-borne pathogens regulations
24FDA Regulation TITLE 21--FOOD AND DRUGS CHAPTER I—FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER H--MEDICAL DEVICESSubpart G--General Hospital and Personal Use Miscellaneous DevicesSec 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:
28Blood Viability Collection Type Storage Temperature Expiration Special ConditionsAcute nomovolemic hemodilution (whole blood)Room temperature8 hours from start of collectionNone1-6 C24 hours from start of collectionStorage at 1-6 C shall begin within 8 hours of start of collectionIntraopeerative blood recovered with processing4 hours from completion of processingStorage at 1-6 C shall begin within 8 hours of start of collectionAmerican Association of Blood Banks Annual Report (2005)