WO2014144534A1

WO2014144534A1 - Flow loop medical device testing system and methods of use

Info

Publication number: WO2014144534A1
Application number: PCT/US2014/028990
Authority: WO
Inventors: Curtis Franklin; Alexander Parker WOOD
Original assignee: Pryor Medical Devices, Inc.
Priority date: 2013-03-15
Filing date: 2014-03-14
Publication date: 2014-09-18

Abstract

A fluid flow loop tester system for simulating human vasculature to test medical device efficacy and a method of use, wherein the system comprises a cardiac duplicator, a tubing array including an occlusion test zone and an access site, at least one pressure sensor disposed at an end of the occlusion test zone, and a fluid source, wherein the cardiac duplicator, tubing array, and fluid reservoir are in fluid flow communication with one another.

Description

TITLE

FLOW LOOP MEDICAL DEVICE TESTING SYSTEM AND METHODS OF USE

BACKGROUND

[001] The invention generally relates to systems and methods for simulating in vitro blood flow conditions for testing medical devices. More particularly, the present invention relates to systems and methods for simulating a human vascular system for testing intraluminal or endovascular devices, including occlusion devices, stents, embolic protection devices, vena cava filters, cardiac or venous valves, delivery systems or the like.

[002] Non-compressible sites of torso vascular injury remain one of the leading causes of potentially preventable death in both active duty troops during wartime conflict and in civilian trauma centers. An example of this type of torso vascular injury is a gunshot wound to the abdomen with a central site of bleeding and a patient in shock. Unlike an extremity injury, wherein a tourniquet could be used for vascular control or direct pressure could be held at select arterial pressure points, vascular injuries to the torso require surgical exposure followed by the often difficult application of vascular clamps for hemorrhage control. In a patient group presenting in shock, the time it takes to achieve such exposure and control may mean the difference between life and death. Specifically, the end stages of shock from hemorrhage or cardiac or neurologic causes are accompanied by critically low blood pressure and circulation to the brain and heart, which eventually lead to neurological death, cardiac arrest, or both.

[003] The use of a compliant balloon as a potentially effective treatment to emergency thoracotomy has been quietly explored for decades. The earliest reports describing this exploration in animal models were in the 1950s. The technique of balloon occlusion in the thoracic aorta of young trauma victims continues to be inadequate, at least in part because of deficient balloon design. It is not generally possible to test balloon occlusion devices in victims of hemorrhagic shock. However, substantial testing is necessary in order to develop and improve these occlusion devices.

[004] On a related note, in addition to testing and simulating the vascular flow environment for testing or simulating arterial or venous occlusion, the inventive vascular simulation system is useful in both testing and practicing clinical procedures for delivery, deployment, use and retrieval of many different endovascular or intraluminal medical device systems under simulated vascular flow conditions. For example, the inventive system may be used to help train clinicians in the delivery, deployment, use and retrieval of vena cava filters, wherein clot capture may be simulated, stent deployment and repositioning may be simulated, angioplasty techniques may be simulated, distal protection techniques associated with angioplasty or stenting, such as with an embolic filter, may be simulated, and valve delivery and placement may be simulated.

[005] What is needed is a system for simulating human vasculature and hemorrhage conditions under simulated vascular compliance conditions in a controllable and repeatable manner. The present invention addresses these needs.

SUMMARY OF THE INVENTION

[006] Provided herein are systems and methods for a fluid flow loop tester for simulating in vitro blood flow conditions of human vasculature in order to test intraluminal or endovascular devices, including occlusion devices, stents, embolic protection devices, vena cava filters, cardiac or venous valves, delivery systems or the like.

[007] Generally, the fluid flow loop tester system comprises a tubing array and a cardiac duplicator. The tubing array further comprises an occlusion test zone and an access site. At least one sensor is operably coupled to the tubing array. At least one sensor may be a pressure sensor, a flow sensor or any other sensor that measures a condition within the tubing array proximal or distal to the device being tested. The cardiac duplicator is configured to simulate a human heart. The tubing array may be configured to simulate the central human vasculature. For example, on the arterial circuit this could include the aortic arch, the descending aorta, celiac trunk, superior/inferior mesenteries, renals and femoral branches. It will be understood by those skilled in the art that the tubing array may be configured to simulate either the arterial system or the venous system. In one embodiment, the tubing array is configured to simulate the human aorta.

[008] In some embodiments, the tubing array may further comprise a hemorrhage segment for simulation of non-compressible torso hemorrhage.

[009] In some embodiments, the system may further comprise an expansion reservoir that imparts a compliance factor to the system, where the expansion reservoir serves to provide a compliance pressure to the tubing array between strokes of the cardiac duplicator, simulating the diastolic pressure of human vasculature.

[010] In one embodiment, the fluid flow loop tester is designed to be as simple as possible. For example, all supra occlusion vessels have been summed into one large vessel with a valve. In an alternative embodiment, a more complex model may be used that is structurally more similar to the human arterial system, such as for testing the introduction path of an occlusion device or other intraluminal or endovascular device. For example, the tubing array may comprise more realistic regions of diameter, transition, angulation, and/or the like. In some embodiments, a compliance factor may be built into the tubing array.

[Oil] In still another embodiment, the system may comprise a plurality of coupled tubing array "loops," wherein each "loop" provides at least one testing function. For example, a second loop may comprise a tubing array made of a material such as silicone to provide advancement and vessel compliance testing.

[012] In another aspect, the present invention comprises a method of testing an occlusion device in simulated in vitro conditions, comprising the steps of: providing a fluid flow loop tester; operating the flow loop tester, such that an initial state is established and measured by at least one sensor; simulating a hemorrhagic shock event within the fluid flow loop tester; disposing the occlusion device within the occlusion test zone via the access site; expanding the occlusion device within the occlusion test zone; and determining a change in pressure or flow in the fluid flow loop tester, so as to permit evaluation of the efficacy of the occlusion device.

[013] In another embodiment, the present invention may comprise a method for simulating a vascular flow and testing an occlusion device within the vascular flow, comprising the steps of: establishing a pulsatile fluid flow within a tubing array, said pulsatile fluid flow having a first pressure representative of a systolic pressure and a second pressure representative of diastolic pressure; simulating a vascular hemorrhage from the vascular flow by releasing fluid flow from the tubing array; introducing and deploying an occlusion device within the tubing array at a position to occlude fluid flow from the simulated vascular hemorrhage; and determining a change in at least one of fluid pressure or fluid flow across the occlusion device within the tubing array. The method may further comprise the step of maintaining hydrostatic pressure within the tubing array during a drop in pulsatile fluid flow.

[014] The systems, apparatuses, and methods are set forth in part in the description which follows, and in part will be obvious from the description, or can be learned by practice of the methods, apparatuses, and systems. The advantages of the methods, apparatuses, and systems will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the methods, apparatuses, and systems as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[015] In the accompanying figures, like elements are identified by like reference numerals among the several preferred embodiments of the present invention.

[016] FIG. 1 is an anatomical representation of the human body, illustrating arterial torso vascular anatomy.

[017] FIG. 2 is an illustration of one embodiment of a fluid flow loop tester system, in accordance with the present invention.

[018] FIG. 3 is an expanded view of a portion of the loop portion a fluid flow loop tester system, in accordance with one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[019] The foregoing and other features and advantages of the invention are apparent from the following detailed description of exemplary embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention rather than limiting, the scope of the invention being defined by the appended claims and equivalents thereof.

[020] As used herein, the terms proximal and distal are from the perspective of a cardiac duplicator at one end of a fluid flow loop tester, such that proximal describes a direction towards the cardiac duplicator, while distal describes a direction away from the cardiac duplicator.

[021] Referring now to Fig. 1, arterial torso vascular anatomy is illustrated with various landing zones within the thoracic aorta 47. For example, a thoracic aortic zone 137 is disposed below a region adjacent to the left subclavian artery 17 along a descending thoracic aorta 47. An aortic zone 138 represents the para visceral aorta between the celiac and the lowest renal artery. An infrarenal aortic zone 139 is disposed between left renal artery 25 and the iliac artery 45, and a common iliac artery zone 141 is disposed between the aortic bifurcation 37 and a distal end of the femoral artery 13. Additional key points of anatomical interest include: the right renal artery 35 and the iliac artery bifurcation 39. The inventive occlusion system may be configured to simulate a hemorrhage in any of the foregoing vessels or zones. For example, an occlusion device may be deployed at a location 21 inferior of the left subclavian artery 17 at the aortic arch, in an effort to augment or support heart and brain perfusion in the setting of end-stage shock resulting from non-compressible torso hemorrhage.

[022] Examples of an occlusion device that may be tested are more fully discussed in commonly assigned and co-pending U.S. Patent Application Serial No. 13/777,667, filed February 26, 2013, which is hereby incorporated by reference.

[023] FIG. 2 illustrates one particular embodiment of a fluid flow loop tester system 100, in accordance with the present invention. Generally speaking, the fluid flow loop tester 100 is a system for simulating a human vascular system in order to test intraluminal or endovascular devices, including occlusion devices, stents, embolic protection devices, vena cava filters, cardiac or venous valves, delivery systems or the like. For purposes of example only, the operation of the fluid flow loop tester 100 will be described with reference to its use with an occlusion device; however, those skilled in the art will understand that the following description is also relevant to testing and/or simulation of other types of intraluminal or endovascular devices.

[024] The fluid flow loop tester 100 generally comprises a cardiac duplicator 200 and a tubing array 300, in fluid flow communication with each other and a fluid source 500. The fluid flow loop tester 100 pumps a fluid from the fluid source 500 through the tubing array 300, by means of the cardiac duplicator 200. The efficacy of an occlusion device/system may be tested with the fluid flow loop tester system of the present invention, by measuring a pressure change caused by the occlusion device in a simulated hemorrhagic shock patient. Alternatively, a flow rate change may be measured to evaluate the occlusion device.

[025] The cardiac duplicator 200 may comprise a stroked phase pump configured to simulate a human heart. The pump may have a variable speed motor 210 to permit simulation of a desired heart rate. The pump may further have an adjustable stroke volume to permit simulation of different ejection fractions associated with different patient conditions (e.g., young or old, fit or out of shape, etc.). In one embodiment, the adjustable stroke volume is achieved with a plurality of tap holes 225 in a disc 220, such that the pump piston 230 and pump chamber 235 may be adjusted to a plurality of stroke lengths and thereby a plurality of stroke volumes. In an alternative embodiment, the length of the piston 230 may be adjusted or a piston of a different length may be attached to alter the ejection fraction. In still another embodiment, the volume of the pump chamber 235 may be adjustable, such as by using a piston/internal pump chamber of a different diameter to alter the ejection fraction. Other means of achieving an adjustable stroke volume, as known in the art, may also be used.

[026] The cardiac duplicator 200 draws a fluid from the fluid source 500 and pumps said fluid through the tubing array 300, the pressure generated during the pumping action simulating the systolic pressure of human vasculature. In one embodiment, the fluid may be water. In another embodiment, it may be necessary to add a solution (e.g., soap, glycerin, etc.) to increase lubricity of the tubing to closer simulate human vasculature. In still other embodiments, the fluid may be blood, blood substitute or some other fluid as known in the art. The cardiac duplicator 200 is coupled to the tubing array 300 such that a phased pump simulating a human heartbeat is obtained. In one embodiment, the cardiac duplicator 200 is coupled to the tubing array 300 between a first one-way valve 310 and a second one-way valve 311, such that when the cardiac duplicator 200 is drawing fluid from the fluid source 500 between stroke phases, fluid is drawn through the first one-way valve 310, but the second one-way valve 311 prevents fluid beyond the valve 311 from being drawn back into the cardiac duplicator 200. Similarly, when the cardiac duplicator 200 is pumping fluid into the tubing array 300 during a stroke phase, the first one-way valve 310 prevents fluid back flow through the valve 310 to the fluid source 500, while the second one-way valve 311 permits fluid flow into the tubing array 300. In this manner, the cardiac duplicator 200 is configured to simulate the pumping of blood by a human heart. In an alternative embodiment, any means known in the art to permit phased pumping of fluid into the tubing array 300 from the cardiac duplicator 200 may be used, as known in the art.

[027] The tubing array 300 generally serves to simulate human vasculature. To most accurately simulate human vasculature, the tubing array 300 may comprise tubing of comparable diameter to major arteries and/or veins of human vasculature. The tubing array 300 comprises a plurality of tubing segments, which may be joined together by connectors or may be formed as a molded integral array unit with the junctions being molded rather than joined by connectors. The tubing array 300 is operably connected to the fluid source 500 and the cardiac duplicator 200. The cardiac duplicator 200 pumps fluid from the fluid source 500 through the tubing array 300 and back to the fluid source 500. Alternatively, the fluid may be pumped to a second fluid collection point rather than the fluid source 500.

[028] The tubing array 300 may generally be understood as comprising a plurality of sections: an occlusion test zone 350, a cumulative supra occlusion zone segment 330, a cumulative infra occlusion zone segment 335, and a hemorrhage simulation segment 333. In one embodiment, the tubing array 300 is configured to simulate the aorta of a human patient, such that the occlusion test zone 350 simulates the aorta between the thoracic descending aorta and the abdominal descending aorta (see FIG. 1). In another embodiment, the tubing array 300 may be configured to simulate the central human vasculature, including the aortic arch, the descending aorta, celiac trunk, superior/inferior mesenteries, renals and femoral branches. It will be understood by those skilled in the art that the tubing array may be configured to simulate either the arterial system or the venous system.

[029] In some embodiments, the cumulative supra segment 330 simulates the vascular system above the occlusion test zone 350 (e.g., zone 137 in FIG. 1), and the cumulative infra segment 335 simulates the vascular system below the occlusion test zone 350 (e.g., zones 139 and 141 in FIG. 1). In one particular embodiment, the cumulative supra segment 330 simulates the combination of all arterial vasculature departing the aorta above the occlusion site under simulation (i.e., right subclavian, carotids, coronaries, left subclavian, etc.). Similarly, in one particular embodiment, the cumulative infra segment 335 simulates the combination of all arterial vasculature below the occlusion site under simulation. A resistance or impedance valve 320 may be disposed at a distal end of each of the cumulative supra occlusion zone segment 330, the cumulative infra occlusion zone segment 335, and the hemorrhage simulation segment 333, to maintain a desired pressure within the tubing array 300. The resistance valves 320 serve to maintain a pressure in the tubing array 300 during the stroke phase of the cardiac duplicator 200, by restricting the rate of fluid flow through the tubing array 300. In restricting the rate of fluid flow through the tubing array 300, the resistance valves 320 simulate the function of capillaries in human vasculature. The resistance valves 320 may be adjustable across a range of resistances to simulate variable rates of flow.

[030] Additionally, the resistance valve 320 associated with the hemorrhage simulation segment 333 may be alternated between a closed and an open position, wherein the closed position simulates no hemorrhage and the open position simulates a hemorrhage. Similarly the resistance valve 320 may be adjustable across a range of resistances to simulate variable rates of flow or hemorrhagic flow through the resistance valve 320. When the hemorrhage segment 333 has its resistance valve 320 closed, fluid is driven through the tubing array 300 by the cardiac duplicator 200 through both the supra and infra segments 330 and 335, but not the hemorrhage segment 333. To simulate a non-compressible torso hemorrhage, the hemorrhage segment 333 may have its resistance valve 320 opened, such that fluid is driven through the tubing array 300 by the cardiac duplicator 200 through the supra segment 330 and the remaining fluid flow is split between the hemorrhage segment 333 and the infra segment 335. The hemorrhage segment 333 may be operably coupled to a hemorrhage fluid collection reservoir 510, separate from the fluid source 500. Alternatively, the hemorrhage segment 333 may be operably coupled to the fluid source 500, rather than a separate collection reservoir 510.

[031] The tubing array 300 further comprises an access site 360, wherein the access site 360 is configured to permit insertion of an occlusion device under test into the occlusion test zone 350. The access site 360 is disposed distal from the occlusion test zone 350, simulating a femoral artery approach. Alternatively, the access site 360 may be located proximal from the occlusion test zone 350.

[032] At least one pressure or flow sensor 370 is coupled to the tubing array 300. In one particular exemplary embodiment, a pressure sensor 370 may be disposed at a proximal end 351 or a distal end 352 of the occlusion test zone 350. Pressure sensors may be used to measure the initial pressure state of the system 100, and also to measure a change in pressure after utilization of an occlusion device within the occlusion test zone 350. In some embodiments, pressure sensors 370 may be disposed at both the proximal end 351 and distal end 352 of the occlusion test zone 350, or at other locations in the tubing array 300 where pressure sensing would be desired. Flow sensors may be used to measure the initial state and rates of fluid flow within the system 100, and also to measure a change in flow after utilization of an occlusion device within the occlusion test zone 350. In some embodiments, flow sensors 370 may be disposed at one or both of the proximal end 351 and distal end 352 of the occlusion test zone 350, or at other locations in the tubing array 300 where flow sensing would be desired.

[033] To more accurately simulate the conditions of human vasculature, an expansion reservoir 400 is operably coupled to the tubing array 300. The expansion reservoir 400 may be coupled to the tubing array 300 distal to cardiac duplicator 200 and proximal to the occlusion test zone 350. The expansion reservoir 400 may be coupled to the tubing array 300 by a tubing segment branching from an insertion segment that receives fluid pumped into the tubing array 300 from the cardiac duplicator 200. The expansion reservoir 400 serves to provide pressure to the tubing array 300 between strokes of the cardiac duplicator 200, simulating the diastolic pressure of human vasculature. Generally speaking, the expansion reservoir 400 serves to store energy during the phase of the cardiac duplicator 200, and release that energy between phases of the cardiac duplicator 200. In one embodiment, the expansion reservoir 400 may comprise a chamber operably coupled to the tubing array 300. The chamber is partially filled with liquid, and partially filled with gas, such as air or some other compressible fluid. In some embodiments, the liquid may be the same as the fluid used in the system 100. The chamber is adapted to prevent the gas within the chamber from escaping. In one embodiment, when the cardiac duplicator 200 undergoes a pump/stroke/beat, a volume of fluid within the tubing array 300 is forced into the chamber of the expansion reservoir 400, applying pressure to the gas within the chamber. Because the gas is a compressible fluid and the liquid/fluid is non-compressible, the gas can be pressurized to equal the pressure of the liquid/fluid during the systolic phase of the duplicator 200 stroke cycle. When the cardiac duplicator 200 is refilling (diastole, i.e., between phased strokes), the pressure of the gas can be temporarily higher than the liquid/fluid, causing a portion of the liquid/fluid to be forced out of the chamber of the expansion reservoir 400 and into the tubing array 300. In this manner, the fluid flow loop tester 100 is constantly under at least some pressure to more accurately simulate in vitro conditions of human vasculature. Alternatively, the expansion reservoir 400 may comprise any means, as known in the art, for storing pressure during a stroke phase of the cardiac duplicator 200 and releasing that pressure into the tubing array 300 between stroke phases of the cardiac duplicator 200, so as to improve simulation of human vasculature by providing a diastolic pressure.

[034] In one embodiment, the fluid flow loop tester 100 is designed to be as simple as possible. For example, all supra occlusion vessels have been summed into one large vessel (330) with a valve 320. In an alternative embodiment, a more complex model may be used that is structurally more similar to the human arterial system, such as for testing the introduction path for an occlusion device or other intraluminal or endovascular device. For example, the tubing array 300 may comprise more realistic regions of diameter, transition, angulation, and/or the like. In some embodiments, the tubing, itself, may be compliant, such as by using silicone tubing that has a modulus of elasticity that can be selected to be comparable to that of an anatomical vessel, in which case the use of reservoir 400 to add a pressure compliance feature to the tubing array 300 may or may not be employed. [035] In still another embodiment, the system 100 may comprise a plurality of coupled tubing array "loops," wherein each "loop" provides at least one testing function. For example, a second loop may comprise a tubing array made of a material such as silicone to provide improved advancement and vessel compliance testing.

[036] FIG. 3 illustrates an expanded view of a loop portion of a fluid flow loop tester system 100 in one embodiment of the present invention. Arrows drawn within the tubing array 300 illustrate the direction of fluid flow in the tube bearing the arrow during operation of the system.

[037] In use, the fluid flow loop tester 100 may be operated such that the cardiac duplicator 200 pumps a fluid through the tubing array 300, simulating blood flow in human vasculature. The fluid pressure or flow may be at a desired region of the tubing array 300, which may be measured by at least one pressure or flow sensor 370 to establish a pre -occlusion pressure or flow measurement. To simulate a hemorrhage situation, the resistance valve 320 for the hemorrhage segment 333 may be opened, thereby simulating a non-compressible torso hemorrhage. Thus, at least some fluid will flow through the hemorrhage segment 333, and may be collected in the hemorrhage fluid collection reservoir 510. Alternatively, the hemorrhage segment 333 may return fluid back to the fluid source 500. An occlusion device being tested may then be inserted through the access site 360 such that the occlusion device is disposed within the occlusion zone 350. The occlusion device may then be utilized to occlude the tubing of the occlusion test zone 350. Depending upon the efficacy of the occlusion device, the fluid flow through the hemorrhage segment 333 will be halted or reduced. The pressure or flow at a desired region of the tubing array 300 may be measured after the occlusion device is utilized. In one embodiment, the pressure supra the occlusion device and occlusion test zone 350 after operation of the occlusion device may be determined, as measured by a pressure sensor 370 proximal the occlusion test zone 350. The changes in the measured pressure or flow proximal and/or distal the occlusion device tested, or at any other region of the tubing array 300, may be analyzed to evaluate the efficacy of the occlusion device.

[038] To simulate patients having different conditions, the cardiac duplicator 200 may be set to any of a plurality of speeds, thereby simulating various heart rates. Further, the cardiac duplicator 200 may be set to any of a plurality of stroke volumes to simulate different ejection fractions of a patient's heart (e.g., low stroke volume for elderly or out of shape, high stroke volume for younger or in shape, etc.). [039] Alternatively, the present invention may comprise a method for simulating a vascular flow and testing an occlusion device within the vascular flow, comprising the steps of: establishing a pulsatile fluid flow within a tubing array, said pulsatile fluid flow having a first pressure representative of systolic pressure and a second pressure representative of diastolic pressure; simulating a vascular hemorrhage from the vascular flow by releasing fluid flow from the tubing array; introducing and deploying an occlusion device within the tubing array at a position to occlude fluid flow from the simulated vascular hemorrhage; and determining a change in at least one of fluid pressure or fluid flow across the occlusion device within the tubing array. The method may further comprise the step of maintaining hydrostatic pressure within the tubing array during a drop in pulsatile fluid flow.

[040] While the invention has been described in connection with various embodiments, it will be understood that the invention is capable of further modifications. This application is intended to cover any variations, uses or adaptations of the invention following, in general, the principles of the invention, and including such departures from the present disclosure as come within the known and customary practice in the art to which the invention pertains.

Claims

CLAIMS What is claimed is:

1. A fluid flow loop tester, comprising:

a. A cardiac duplicator;

b. A tubing array including an occlusion test zone and an access site, the tubing array in fluid flow communication with the cardiac duplicator;

c. At least one sensor operably coupled to the tubing array; and

d. A fluid source in fluid flow communication with the cardiac duplicator and the tubing array.

2. The fluid flow loop tester of claim 1, further comprising an expansion reservoir at least partially filled with a non-compressible liquid and at least partially filled with a compressible fluid, wherein the expansion reservoir imparts a pressure to the fluid flow loop tester between strokes of the cardiac duplicator.

3. The fluid flow loop tester of claim 2, wherein the expansion reservoir is configured to build up a stored pressure during a stroke phase of the cardiac duplicator and release said stored pressure between stroke phases of the cardiac duplicator.

4. The fluid flow loop tester of claim 2, wherein the expansion reservoir is configured such that during a stroke phase of the cardiac duplicator additional non-compressible liquid enters the chamber and compresses the compressible fluid, and between stroke phases of the cardiac duplicator the compressed compressible fluid pushes the additional non- compressible liquid into the tubing array.

5. The fluid flow loop tester of claim 1, wherein the cardiac duplicator is coupled to the tubing array between a first one-way valve and a second one-way valve.

6. The fluid flow loop tester of claim 1, wherein the tubing array further comprises:

a. A supra occlusion segment;

b. A hemorrhage simulation segment; and

c. An infra occlusion segment.

7. The fluid flow loop tester of claim 6, further comprising a resistance valve operably coupled to each of the supra occlusion segment, hemorrhage simulation segment, and infra occlusion segment. The fluid flow loop tester of claim 6, wherein the supra occlusion segment and the infra occlusion segment are operably coupled to the fluid reservoir.

The fluid flow loop tester of claim 6, wherein the hemorrhage simulation segment is operably coupled to a hemorrhage fluid collection reservoir.

The fluid flow loop tester of claim 1 , wherein the access site is configured to permit insertion of a medical device within the occlusion test zone.

The fluid flow loop tester of claim 10, wherein the medical device comprises an occlusion device.

The fluid flow loop tester of claim 1 , wherein the cardiac duplicator comprises a pump having an adjustable stroke volume.

The fluid flow loop tester of claim 1 , wherein the cardiac duplicator comprises a pump having an adjustable stroke speed.

The fluid flow loop tester of claim 1 , wherein the sensor comprises at least one pressure sensor or a flow sensor.

The fluid flow loop tester of claim 1 , wherein the tubing array is configured to simulate human vasculature.

A fluid flow loop tester system, comprising:

a. A cardiac duplicator, wherein the cardiac duplicator comprises a stroke-phased pump; b. A tubing array in fluid flow communication with the cardiac duplicator , the tubing array comprising a plurality of segments and including an occlusion test zone and an access site, wherein the plurality of segments comprise at least a supra occlusion segment, a hemorrhage simulation segment, and an infra occlusion segment;

c. At least one sensor operably coupled to the tubing array;

d. A fluid source in fluid flow communication with the cardiac duplicator and the tubing array; and

e. An expansion reservoir at least partially filled with a non-compressible liquid and at least partially filled with a compressible fluid, wherein the expansion reservoir imparts a pressure to the fluid flow loop tester between strokes of the cardiac duplicator.

The fluid flow loop tester of claim 16, wherein the cardiac duplicator has an adjustable stroke volume. The fluid flow loop tester of claim 16, wherein the cardiac duplicator has an adjustable stroke speed.

The fluid flow loop tester of claim 16, wherein the sensor comprises at least one of a pressure sensor or a flow sensor.

The fluid flow loop tester of claim 16, wherein the tubing array is configured to simulate human vasculature.

A method of testing an occlusion device in simulated in vitro conditions, comprising the steps of:

a. Operating a fluid flow loop tester, such that an initial state is established and

measured by at least one sensor;

b. Simulating a hemorrhagic shock event within the fluid flow loop tester;

c. Disposing the occlusion device within an occlusion test zone of the fluid flow loop tester;

d. Deploying the occlusion device within the occlusion test zone; and

e. Determining a change in pressure or flow in the fluid flow loop tester, so as to permit evaluation of the efficacy of the occlusion device.

A method for simulating a vascular flow and testing an occlusion device within the vascular flow, comprising the steps of:

a. Establishing a pulsatile fluid flow within a tubing array, said pulsatile fluid flow

having a first pressure representative of a systolic pressure and a second pressure representative of diastolic pressure;

b. Simulating a vascular hemorrhage from the vascular flow by releasing fluid flow from the tubing array;

c. Introducing and deploying an occlusion device within the tubing array at a position to occlude fluid flow from the simulated vascular hemorrhage; and

d. Determining a change in at least one of fluid pressure or fluid flow across the

occlusion device within the tubing array.

The method of Claim 22, further comprising the step of maintaining hydrostatic pressure within the tubing array during a drop in pulsatile fluid flow.