Patent Application
20230338703
None
This invention relates to the infusion of medications and/or fluids into a patient, and/or the removal of blood samples therefrom. More specifically, this invention relates to an apparatus, system and method of medication/fluid infusion into a patient and/or blood removal from a patient on an extracorporeal membrane oxygenation (ECMO) and/or cardiopulmonary bypass (CPB) fluid circuit such that the need for utilizing a central line on the patient is avoided, thus avoiding or minimizing the associated bloodstream infections and numerous other disadvantages associated with central line use. Additionally, this invention obviates any need for dialysis catheters as well. Finally, the invention permits for a safe and rapid access for endovascular procedures.
Patients requiring the use of ECMO due to cardiac and/or respiratory failure utilize this treatment for extended periods of time. Given that they are critically ill, the need for central venous access at all times for infusions of medication and/or fluids (for treatment), and/or removal of blood samples (for laboratory analysis), and/or administration of dialysis (due to renal failure) is necessary. Additionally, patients who undergo surgery and require CPB also benefit from central venous access for the quick delivery of medications and/or fluids and/or removal of blood samples for analysis. Moreover, central vascular access for various other procedures/monitoring performed on an urgent or continuous basis is of great importance. These may include, without limitation: imaging, including pulmonary and peripheral angiographies; hemodynamic monitoring/cardiac function analysis, including right and left heart catheterization and intermittent or continuous pressure monitoring; transvenous pacemaker insertions; and any other endovascular procedures, such as embolization etc.
However, central venous access and dialysis catheters each pose a significant risk to the patient. Central venous access and dialysis catheterization are each possible via the insertion of a central line into the patient. This central line, also known as a central venous catheter, is a catheter or tube placed by medical practitioners within the large veins of a patient's neck, chest or groin for providing medications and/or fluids to a patient during critical or intensive care periods, as well as removing and sampling blood from the patient for laboratory analysis. Central lines generally differ from peripheral intravenous catheters (i.e., PIVs), which typically provide lower volumes of medications and/or liquids into a vein located near the skin's surface (i.e., on the arm or the hand), because of their location proximal to the heart and their ability to remain in place for longer time durations.
However, the foregoing use of central lines is fraught with disadvantages. A primary disadvantage is the risk of a patient contracting a central line associated bloodstream infection (i.e., CLABSI); which occurs when bacteria, viruses and/or other germs enter the blood stream through the central line and/or insertion site. To avoid the occurrence of CLABSI, medical practitioners must follow strict protocols to ensure that both the central line and insertion site on the patient remains sterile when inserting the line. Medical practitioners must also follow stringent infection control practices when checking and/or replacing the line, as well as changing the associated dressing (i.e., bandages, etc.).
Although numerous practices exist that promote sterile central line placement and maintenance, namely, hand hygiene practices and the use of sterile barrier precautions, to include sterile gloves, gowns, caps, masks and drapes, these practices and precautions are both time consuming and inconsistent between different medical practitioners. Of course, during a given medical emergency or critical care scenario, time is of the essence; where mere minutes may affect the success of a patient's medical outcome when trying to insert a central line for the infusion of critical medications and/or fluids into a patient. The insertion of these lines usually requires the assimilation of instruments (i.e. ultrasound), drapes, preps, etc., with the central line kit having many components that make it cumbersome, time consuming and expensive. Furthermore, only specially-trained practitioners can place these lines, usually in an intensive care unit, or an emergency or operating room setting.
Another disadvantage present with the use of central lines is the potential for injury to a patient's surrounding anatomical structures, i.e., blood vessels, nerves, etc., during its placement within the body. For example, placement of the line via a central venous access in the internal jugular vein can lead to injury of the carotid artery; placement via a subclavian approach can lead to injury of the subclavian artery or result in pneumothoraces due to lung injury; and placement via a femoral approach can lead to injury of femoral arteries, nerves, and bowel (possibly resulting in life-threatening retroperitoneal hematomas or bowel perforations).
Air embolus, while uncommon, also may result in a catastrophic event during central line placement. All of these complications are further exacerbated in obese individuals, where line placement becomes severely challenging due to body habitus. Moreover, central lines may also present a risk of pseudoaneurysm or arterio-venous fistula formation, requiring extensive tissue repair. Their long-term use may also create stenotic regions within the vessels, thus dangerously limiting blood flow (venous stenosis) there-through. Similarly, upper body central lines may cause superior vena cava syndrome leading to impaired venous blood return to the heart.
Yet other disadvantages relate to the insertion process utilized during such placement. A guide-wire, utilized for guiding the line into a given blood vessel, can be lost within the vessel itself, thereafter requiring the execution of yet further time-consuming procedures to retrieve the wire from therein. Also, the existence of another line or ECMO cannula within the patient creates locational difficulties when placing these central lines, thus requiring the assistance of other modalities, such as fluoroscopy. Also, in addition to utilizing ECMO, if the patient is anti-coagulated with medications and/or has pre-existing bleeding diathesis, the likelihood of having bleeding complications from line insertion is significantly greater. Furthermore, an incorrect placement of the original central line (e.g. terminating in the contralateral internal jugular vein instead of the superior vena cava) would require that the line be repositioned or replaced, again adding to the risk of the original procedure. Additionally, central lines commonly have a lifespan of approximately 7-10 days, depending on institution protocols, after which replacement of the line becomes necessary due to risk of the aforementioned central line-associated bloodstream infection (CLABSI) occurring.
A further disadvantage of central lines relates to limitations presented by their physical structure. The lines generally utilize infusion ports that define small bore diameters (creating fluid flow or pressure restrictions there-though) and/or are limited in quantity (i.e., a maximum of four ports). This limits both the number of different infusions that can be performed due to medication compatibility restrictions, and the rate at which they can be administered. Furthermore, central lines have malfunctioned due to either a kinking of the line or a thrombus formation (blood clot), thus necessitating manipulation or replacement of the line itself. Deep venous clots may lead to pulmonary emboli which may be life-threatening. Finally, patient comfort is an important factor. Despite the use of a local anesthetic, central line placement often proves to be a painful or traumatic experience for the patient. Moreover, having a central line in the neck, chest, or groin of a patient limits the patient's mobility and comfort throughout his or her hospital stay and poses a source of infection thereafter.
Additionally, similar problems are encountered when running a hemodialysis (HI)) machine or continuous renal replacement therapy (CRRT) in cases of renal failure in critically ill hospitalized patients on ECMO. Current techniques to perform HD or CRRT on ECMO patients rely on the placement of peripherally-inserted central dialysis catheters. Not only do these catheters have the same disadvantages of central lines, such as infection, thrombus formation etc they are highly prone to obstruction/occlusion due to the dialysis catheter's small caliber; thus requiring anti-coagulants or line replacement.
Finally, obtaining vascular access for procedures such as endovascular imaging, hemodynamic monitoring/cardiac function analysis, transvenous pacing, or any other endovascular procedures are fraught with the same hazards as with obtaining central line access. And given that such procedures often require the placement of a large bore central access catheter or cannula, the dangers are even greater.
Thus, what is needed are an apparatus, system and method for infusing patients with the greater volumes of medications and/or fluids possible with central line use, as well as for removing blood samples from patients for analysis, without the need for inserting the central line itself. The apparatus, system and method should also allow for establishing HD/CRRT connections into a much larger flow channel, thus preventing any pediments to the ITD/CRRT flow due to their smaller diameter. The apparatus, system and method should further allow for exclusive external access because nothing is inserted into the patient and there is no remnant foreign object (i.e., catheter guide-wire) of concern to medical practitioners. Given that the continuous and high-volume flow of ECMO circuits minimizes bloodstream infections compared to central line placements, the apparatus, system and method should allow for long term vascular access without requiring any apparatus replacement. Moreover, the apparatus, system and method should also accommodate the simultaneous infusion of multiple medications and/or fluids, and/or the simultaneous removal of blood samples for laboratory analysis. Finally, the apparatus, system and method should eliminate or minimize blood loss through an infusion/extraction point via a lowering of its associated internal fluid (i.e., blood) pressure. The present invention satisfies these foregoing disadvantages and presents other advantages as well.
This invention relates to the infusion of medications and/or fluids into a patient, and/or the removal of blood samples therefrom. More specifically, this invention relates to an apparatus, system and method of administering such medication/fluid infusion into a patient and/or blood removal from a patient on extracorporeal membrane oxygenation (ECMO) and/or cardiopulmonary bypass (CPB) fluid circuits such that the need for utilizing central lines on the patient is avoided, thus also avoiding or minimizing the associated bloodstream infections and numerous other disadvantages associated with central line use and other means of vascular access. Additionally, this invention obviates any need for dialysis catheters as well. Finally, the invention permits for a safe and rapid access for endovascular procedures.
A system for infusing medications and/or fluids, and/or removing blood samples from a patient comprises a pump configured for fluid communication with the patient, and an oxygenator in fluid communication with the pump and configured for fluid communication with the patient, with the pump, oxygenator and associated fluid communications comprising a fluid circuit. The fluid circuit is utilized in a medical setting to receive the blood of the patient, oxygenate it, and return it to the patient. Hollow, medical grade tubing facilities the fluid communication throughout the circuit, thus carrying the blood from the patient to and/or between each component, and returning it to the patient.
At least one vessel may be located within the circuit, with the vessel comprising an axial member having forward, medial and rearward portion, and defining a member lumen in fluid communication with the fluid circuit. The member lumen extends through the forward, medial and rearward portions, terminating at forward and rearward openings.
The member lumen defines a medial cylindrical inner surface within the member's medial portion, and forward and rearward cylindrical inner surfaces terminating at the forward and rearward openings. The inner diameter of the lumen in the medial portion is smaller than that of the forward and/or rearward portions. At least one gateway unitary with the member and defining a gateway lumen through the member's medial portion and in fluid communication with the member lumen is defined therein. The at least one gateway lumen terminates at a gateway opening at an outer end of the at least one gateway, with the gateway outer end operably engageable with an input/extraction conduit for fluid communication with the gateway lumen.
According to the well-known Venturi effect, a flow of blood through the smaller inner diameter of the member lumen within the medial portion results in a reduction in fluid pressure therein, thus resulting in the creation of a vacuum point within the member lumen of the medial portion such that a medication and/or fluid additive is drawn into the opening and lumen of the at least one gateway in fluid communication therewith. The reduced pressure within the medial portion also eliminates or minimizes blood loss through the at least one gateway.
The vessel defines a member outer surface having member forward and rearward engagement surfaces located proximal to both the respective forward and rearward ends. The forward and rearward engagement surfaces create a fluid-tight frictional connection with the inner surface of the tubing facilitating the fluid communication between circuit's components. The at least one gateway also defines a gateway outer surface having a gateway engagement surface located proximal to the gateway's outer end. The gateway engagement surface of the at least one gateway creates a fluid-tight connection with an input/extraction conduit utilized for infusing medications and/or fluids into the circuit or removing blood samples from the circuit.
An alternate embodiment of the access vessel further comprises at least one selectively occludable port unitary with the member and located forwardly or rearwardly of the medial portion, Unlike the aforementioned valved cap, the selectively occludable port allows for the insertion of a catheter or guide-wire into and through the vessel while preventing flow of blood therefrom. The at least one selectively occludable port defines an occludable port lumen through the member and in fluid communication with the member lumen. The at least one occludable port lumen terminates at an occludable port opening at an outer end of the at least one selectively occludable port, with the occludable port opening configured to accept an insertion of a catheter and/or guide-wire there-through for further insertion through the member lumen and ultimately into a patient.
An inwardly expandable tubular balloon is located within the at least one selectively occludable port, adjacent to an inner surface of the occludable port lumen to facilitate the port's selective occludability. In a deflated state, the volume of the tubular balloon is minimal such that an interior volume of the occludable port lumen remains undisturbed and un-occluded to allow for the flow of fluids or the insertion of catheters and/or guide-wires through the at least one occludable port. In an inflated state, the tubular balloon expands inwardly such that the interior volume of the occludable port lumen is occluded to block any fluid flow there-though. To facilitate an operation of the at least one selectively occludable port via the inflation and deflation of the tubular balloon, the balloon is in fluid communication with an actuatable gas or liquid source. When actuated, the gas or liquid source forces gas or liquid from the source and into the tubular balloon to cause the balloon to expand within the occludable port lumen.
In other embodiments, the at least one selectively occludable port may be removably connected to the vessel, with such connection including a connection to the outer end of the at least one gateway of the vessel. While this foregoing description and accompanying figures are illustrative of the present invention, other variations in system and method are possible without departing from the invention's spirit and scope.
This invention relates to the infusion of medications and/or fluids into a patient, and/or the removal of blood samples therefrom. More specifically, this invention relates to an apparatus, system and method of administering such medication/fluid infusion into a patient and/or blood removal from a patient on extracorporeal membrane oxygenation (ECMO) and/or cardiopulmonary bypass (CPB) fluid circuits such that the need for utilizing central lines on the patient is avoided, thus also avoiding or minimizing the associated bloodstream infections and numerous other disadvantages associated with central line use and other means of vascular access. Additionally, this invention obviates any need for dialysis catheters as well. Finally, the invention permits for a safe and rapid access for endovascular procedures.
In the embodiment of
In the embodiment of
Further variations of the circuit 25 are understood in the art, to comprise cardiopulmonary bypass (i.e., CPB) and other circuits as well. Unlike prior art ECMO, CPB and other similar fluid circuits, however, the present system 5 utilizes at least one access vessel 55 within with the fluid circuit 25. As illustrated within
Referring to
In a preferred embodiment of the invention, the vessel 55 comprises rigid, medical grade plastic such as polycarbonate, polypropylene, polyethylene and/or custom-made polymers, with all of the components of the vessel 55 being unitary with one another as a result of its underlying preferred manufacture via a precise plastic injection molding process. The rigidity of the plastic allows the vessel 55 to operably engage the more flexible plastic tubing 26 of the circuit 25 that facilitates the fluid communication between the pump 15, oxygenator 20 and patient 10. It is understood, however, that the vessel 55 and all or some of its underlying components may comprise polycarbonate, aluminum, stainless steel as well as aluminum and other similar materials known in the art for providing the desired material properties.
As better illustrated in the sectional view of
Referring now to both
According to the well-known Venturi effect, a flow of blood through the smaller inner diameter of the member lumen 80 within the medial portion 70 results in a reduction in fluid pressure therein, thus resulting in the creation of a vacuum point within the member lumen of the medial portion such that a medication and/or fluid additive is drawn into the opening 145 and lumen 140 of the at least one gateway 135 in fluid communication therewith. The reduced pressure within the medial portion 70 also eliminates or minimizes blood loss through the at least one gateway 135. In one embodiment of the invention, the precise volumetric flow rate of the medication and/or fluid into and through the gateway is achieved via a control of the cross-sectional area (i.e., diameter) of the member lumen 80 within the member's medial portion 70, The relationship between the components of the vessel 55, the blood flowing there-through, and the medication and/or other fluids that is drawn to the at least one gateway 135, and/or the blood flow prevented from exiting the at least one gateway, is readily ascertained via the Bernoulli equation:
P
1+(½)ρ1υ1+ρ1g1h1==P2+(½)ρ2υ22+ρ2g2h2
Given the known value for patient blood pressure (P1) existing within the forward portion 65 of the member 60, we seek to determine the downstream pressure (P2) of the blood existing within the member's medial portion 70. Assuming equivalent values existing throughout the member 60 for blood density (ρ1=ρ2), the acceleration due to gravity (g1=g2), and the height from the ground (h1=h2), these variables cancel each other out such that P2 may be determined as follows:
P
2=(P1+(½)ρ1υ12)−(½)ρ2υ22, where υ1=Q1/(πR12) and υ2=Q2/(πR22).
We know, via clinical determination, the pressure (P1) of the blood existing within the forward portion 65 of the member 60 (i.e., between about 15 and 300 mm Hg, optimally about 240 mm Hg). We also know the flow rate (Q1) of the blood though the forward portion 65 of the member 60 (i.e., between about 3 and 5 L/min, optimally about 4 L/min), and that this flow rate remains constant (i.e., Q1=Q2) through the medial portion 70 of the member, regardless of the internal diameter of the member's lumen 80, Similarly, we additionally know the density (ρ1) of the blood (i.e. about 1 gm/ml) through the forward portion 65 of the member 60, and that this density also remains constant (i.e., ρ1=ρ2) through the medial portion 70 of the member, also regardless of the internal diameter of the member's lumen 80. Finally, we further know the radius (R1)=½ the diameter (D1; i.e. standardized circuit tubing 26 having an internal lumen diameter of about ⅜-inch and about ½-inch, respectively) of the forward portion 65.
Theoretically, we can thus vary the radius (R2;=½ the diameter of D2) of the medial portion 70 to determine to determine numerous optimal values for the pressure (P2) existing within the medial portion of the at least one vessel 55. Thus, assuming for the sake of example: P1=about 250 mm Hg; Q1=Q2=about 4 L/min=about 4000 ml/min; ρ1=ρ2=about 1 gm/ml; D1=about 0.375 in=about 0.9525 cm=about 9.525 mm for venous tubing; and D2=about 0.283 in=about 0.7189 cm=about 7.189 mm, we can calculate P2 to be about 243 mm Hg; which represents an approximate 25% reduction in lumen diameter from the forward portion 65 of the member to the medial portion 70. Similarly, utilizing an approximate 50% reduction in diameter from the forward portion 65 to the medial portion 70, namely, where D1=about 0.375 in and D2=about 0.1875 in, we calculate P2 to be about 200 mm Hg.
To verify the foregoing, tests of the vessel 55 within a closed-loop system, comprising of all components of the fluid circuit 25 of
First, upon measuring the fluid pressures at various points in the circuit 25, a pressure differential “PD” between a ½-inch inner diameter tubing 26 and the medial portion 70 of the vessel 55 was observed to be directly related to the vessel's medial portion inner diameter, namely, a 7 mm Hg drop PD for a ⅜-inch medial portion inner diameter (
For the sake of completeness, the foregoing pressure differential tests were also conducted while utilizing a one-way valve adapter (to be further discussed) to occlude the at least one gateway 135 of the vessel 55. Such valve adapters are typically utilized in drawing blood samples from a patient, via the attachment of a syringe there-through, while preventing an outflow of blood there-from in the absence of the attached syringe. Despite the vacuum present within the medial portion 70 of the vessel 55, no external air was drawn into the circuit 25 through the valve adapter. As such, the access vessel 55 is safe for use with valve adapters commonly used in facilitating blood draws/sampling from the fluid circuit 25.
The foregoing calculated pressures (P2) and associated diameters (D2) are critical because they ensure fluid pressure reductions that eliminate or minimize blood loss through the at least one gateway 135 and/or sufficient to draw medications/fluid into the at least one gateway, while also not increasing the blood velocity within the vessel's medial portion 70 to dangerous levels that may result in blood cell sheer (leading to hemolysis, for example). They further ensure the presence the desired vacuum within the vessel's medial portion 70 sufficient to draw medicine and/or fluid into the circuit 25, yet insufficient to draw undesirable air through a valve cap (to be further discussed) occluding the at least one gateway 135. Nonetheless, although about 25% and 50% diameter reductions between tubing and medial portion inner diameters are recited by example herein, other diameters (D2) are nonetheless possible as well, to include those resulting in reductions of between about 1% and 99%.
Referring again to
The at least one gateway 135 also defines a gateway outer surface 185 having a gateway engagement surface 190 located proximal to the gateway's outer end 150. The gateway engagement surface 190 of the at least one gateway 135 creates a fluid-tight connection with the input/extraction conduit 155. In the embodiment illustrated in
With regard to infusing medications and/or fluids, and/or removing of blood samples through the at least one gateway 135, utilization of the Luer Lock is preferred to allow for the standardized connection of the access vessel 55 to various embodiments of the input/extraction conduit 155, to comprise, without limitation, connection to: a syringe for quickly injecting larger volumes of medication and/or fluid into a patient during critical care scenarios; common IV drip containers for slowly infusing pre-determined volumes of such medicine and/or fluids into the patient; and/or Patient-Controlled Analgesia (i.e., PCA) pumps for administering precise units of patient-controlled pain medications, as prescribed by a qualified medical professional; and/or utilization in conjunction with a hemodialysis (HD) machine or continuous renal replacement therapy (CRRT) in cases of renal failure. As discussed earlier, current techniques to perform HD or CRRT on ECMO patients rely on the placement of peripherally inserted central dialysis catheters, which not only have the same downsides of central IV lines, but they are highly prone to complete obstruction/occlusion requiring anti-coagulants or catheter replacement. This issue occurs due to the higher resistance of the dialysis catheter's small caliber. However, the current embodiment allows the at least one gateway 135 to directly connect to a much larger flow channel thus preventing any impediments to the HD/CRRT flow.
For embodiments of the at least one vessel 55 having more, than one gateway of the at least one gateway 135, the foregoing input/extraction conduits may be connected to the respective multiple gateways for simultaneous or successive injection and/or infusion of the respective medications and/or fluids into a patient. For example, if a patient incurs a sudden drop in blood pressure through internal bleeding) while the infusion pump is infusing medications through one gateway of the vessel, a medical practitioner can rapidly inject large volumes of pressure balancing fluids, such as blood or saline, through another gateway of the vessel. Similarly, simultaneous blood sampling can also be performed.
In the vessel 55 embodiments of
Again, for embodiments of the at least one vessel 55 having more than one gateway of the at least one gateway 135, the foregoing input/extraction conduits may be connected to the respective multiple gateways for simultaneous or successive removal/sampling of blood from the patient. Similarly, input/extraction conduits may be connected to one or e gateways for simultaneous or successive injection and/or infusion of the respective medications into the patient while other input/extraction conduits may be connected to the remaining one or more gateways for simultaneous or successive removal/sampling of blood from the patient.
Referring to
The at least one occludable port lumen 215, in turn, terminates at an occludable port opening 220 at an outer end 225 of the at least one selectively occludable port 210, with the occludable port opening configured to accept an insertion of a catheter and/or guide-wire there-through for further insertion through the member lumen 80 and ultimately into a patient. To facilitate an ease of insertion of the catheter and/or guide-wire through the at least one selectively occludable port 210, into and through the member lumen 80 and ultimately into a patient, the at least one selectively occludable port is oriented at an angle in relation to an axis 226 of the member lumen 80 such that any catheter and/or guide-wire inserted through the at least one occludable port is directed ultimately into the larger-diameter cylindrical inner surfaces 115 or 125 of the respective forward or rearward portions 65 or 75. The angle of the at least selectively one occludable port 210 from the axis 226 is between about 1 degree and 179 degrees, preferably between about 25 degrees and 165 degrees, and optimally about 45 degrees from the axis 226. Directing the catheter and/or guide-wire into the smaller-diameter inner cylindrical surface 110 of the medial portion 70 is to be avoided due to the likely constriction of the medial portion about the catheter and/or guide-wire, and also because of the likelihood of the catheter and/or guide-wire's forward end catching and snagging on the interior opening 132 of the at least one gateway 135 terminating within the medial cylindrical inner surface. Although
Referring to
An outer surface 277 of the outer sheet 240 is located adjacent, and optionally secured to, the inner surface 232 of the occludable port lumen 215. The optional securement of the outer sheet 240 to the inner surface 232 can comprise an adhesive, thermal or other bonding means understood in the art as bonding two surfaces to one another. In a deflated state, closed volume 272 of the tubular balloon 275 is minimal such that the inner sheet 235 is located adjacent to the outer sheet 240 and an interior volume 280 of the occludable port lumen 215 remains undisturbed and un-occluded to allow for the flow of fluids or the insertion of catheters and/or guide-wires through the at least one occludable port 210. In the absence of a catheter and/or guide-wire located within the balloon's center 285, the interference fit of the balloon's inner sheet 235 with itself will minimize or “close” the balloon's center such that the flow of blood outwardly there-though is minimized or occluded.
In an inflated state, the inner tubular sheet 235 inwardly separates from the outer tubular sheet 240, as the internal closed volume 272 of the tubular balloon 275 fills with a gas or liquid, and expands inwardly to create an interference fit with itself such that the interior volume 280 of the occludable port lumen 215 is occluded to block any fluid flow there-though. However, because the inner tubular sheet 235, despite creating an interference fit with itself, nonetheless continues to define a tubular center 285 there-through, catheters and/or guide-wires medical devices may be inserted through the center, or otherwise remain located within that center, while the tubular balloon 275 remains inflated.
Thus, when inflated, an interference fit exists between an inner surface 290 of the inner sheet 235 of the balloon and an outer surface of the catheter or guide-wire to occlude any fluids from otherwise flowing between these surfaces and through the occludable port lumen 215 about the catheter or guide-wire. To aid in the any insertion or retraction of the catheter or guide-wire into or out of the inflatable balloon's center 285 of the inflated tubular balloon 275, the inner surface 290 of the inner tubular sheet 235 is optionally coated with a hydrophilic coating to reduce any frictional resistance between the inner sheet and the catheter or guide-wire located within the balloon's center.
To facilitate an operation of the at least one selectively occludable port 210 via the inflation and deflation of the tubular balloon 275, the balloon's closed volume 272 is in fluid communication with an actuatable gas or liquid source 295. In the embodiment of
When actuated (
Of course, when the button 355 is released (
Although
In the embodiment illustrated in
In use for infusing medications and/or fluids into a patient, a pump configured for fluid communication with a patient is provided. An oxygenator in fluid communication with the pump, and configured for fluid communication with a patient, is also provided. The pump, oxygenator and associated fluid communications comprise a fluid circuit. At least one access vessel is located within the fluid circuit, with the vessel comprising an axial member having forward, medial and rearward portions and defining a member lumen in fluid communication with the fluid circuit. The member lumen extends through the forward, medial and rearward portions of the member and defines a forward opening in the forward portion and a rearward opening in the rearward portion.
The lumen further defines an inside diameter within the medial portion that is smaller than an inside diameter defined within both the forward and rearward portions of the member. The vessel further comprises at least one gateway defining a gateway lumen through the medial portion of the member and in fluid communication with the member lumen. The gateway lumen further defines a gateway opening at an outer end of the gateway, with the gateway outer end operably engageable with an input/extraction conduit for fluid communication with the gateway lumen.
The at least one gateway of the vessel is utilized for infusing medications or other fluids into the fluid circuit, or for extracting blood samples from the circuit. An input/extraction conduit is connected to the at least one gateway for infusing medications or fluids into the circuit or extracting blood samples from the circuit.
When infusing medications or other fluids into the circuit, the input/extraction conduit may comprise, without limitation, connection to: a syringe for quickly injecting larger volumes of medication and/or fluid into patient during critical care scenarios; common IV drip containers for slowly infusing pre-determined volumes of such medicine and/or fluids into the patient; and/or Patient-Controlled Analgesia (i.e., PCA) pumps for administering precise units of patient-controlled pain medications, as prescribed by a qualified medical professional; and/or utilization in conjunction with a hemodialysis (HD) machine or continuous renal replacement therapy (CRRT) in cases of renal failure.
When extracting blood samples from the circuit, the input/extraction conduit may comprise a common syringe, or that relating to a vacuum gibe (i.e., Vacutainer). Occlusion caps and/or valved caps may be attached to the at least one gateway to facilitate the selective use of any one or more of the gateways simultaneously sequentially.
In use in another embodiment, the at least one access vessel is located within the fluid circuit, with the vessel further comprising at least one selectively occludable port defining a port lumen through the member and in fluid communication with the member lumen, and an inflatable tubular balloon defined within the port lumen. The port lumen further defines a port opening at an outer end of the port, with the tubular balloon selectively inflatable to selectively occlude the port lumen. A small amount of an actuatable gas or liquid source is pushed to inflate the tubular balloon to occlude the port lumen, and released to deflate the tubular balloon to open the port lumen. In use in yet another embodiment, the at least one selectively occludable port is removably connected to the member.
While this foregoing description and accompanying figures are illustrative of the present invention, other variations in system and method are possible without departing from the invention's spirit and scope.
