1. Field of the Invention
The present invention relates to a turbulence minimizing connector for allowing multiple streams of liquid to enter the connector, flow together therein, and exit the connector with minimal mixing.
2. Description of the Prior Art
Heretofore, multiple fluid-carrying lumens (also referred to as extensions, catheters or multi-lumen catheters) have been proposed for mixing components therein prior to delivery of the mixture to a patient, i.e., a human body.
At a distal end 30 of the extension 12 is a coupling connector 32 that includes a mixing or “common” chamber 33 illustrated in FIGS. 2 to 4. Distal connectors existing prior to the '167 Patent were realized by an industry standard connector, referred to as a luer connector 32. The '167 Patent supplied the connector 32 to provide a fluidic interface between the extension 16 and an infusion needle or intravenous catheter 34. The outlet of the connector 32 is connected to the needle/catheter 34, which is inserted into the body 38 and is, typically, held therein by a wing tape or bandage 40.
FIGS. 2 to 4 illustrate that the mixing chamber 33 in the connector 32 has an outer cylindrical wall or tubular portion 42 that is received over the distal end 30 of the multi-lumen intravenous extension tubing 12.
With multi-lumen medical tubing (e.g., the multi-lumen intravenous extension 12 of the '167 Patent), fluids exit the connector 14 (or the extension 16) along with the fluid passing through the main lumen 52. It would be beneficial to have these fluids not intermix and remain separated for as long as possible, prior to vascular entry. If such intermixing is prevented, then the intended additionally added medication is administered with a minimal degree of dilution and/or interaction with other medications until it enters the vessel intended to receive such medications. As such, unwanted boluses of medication and interactions are avoided. It is known that medications, especially, injected anesthesia, should be administered with constancy and control, and not with randomly sized or chaotic boluses because differential administration of such medicines can have serious, if not deadly, consequences.
Based upon the above considerations, it would be beneficial to provide a device that minimizes turbulence of the co-delivered fluids.
It is accordingly an object of the invention to provide a turbulence minimizing device for multi-lumen fluid delivery systems and a method for minimizing turbulence in such systems that overcome the hereinafore mentioned disadvantages of the heretofore-known devices and methods of this general type and that are configured to integrate with existing standardized infusion systems to minimize chaotic admixing of fluids that are to be transfused concomitantly.
The present invention is an improvement upon prior art connectors for infusion systems. In one exemplary embodiment, the present invention improves upon the multi-lumen intravenous extension described in the '167 Patent. This extension is used for transmitting liquids in a body and for infusing the fluids individually undiluted and unprecipitated as close as possible to the point where they are injected into the blood stream, for example. While the turbulence minimizing device of the present invention can be used with the multi-lumen extension of the '167 Patent, it is not limited to use with this device. The present invention, however, is particularly useful when combined with the '167 device and, therefore, portions of the '167 disclosure are included herein. For clarity, the '167 disclosure is incorporated by reference herein in its entirety. Inclusion of the '167 catheter herein should not be taken as applicable only to this exemplary embodiment of a medical fluid infusing device. Those having ordinary skill in the art of such devices will appreciate the improvement that the present invention may provide to other prior art devices that deliver medicinal fluids.
The connector of the present invention is positioned between an intra-vascular or intravenous access site and an infusion system typically including a steady supply of saline and syringes or syringe connectors or medicinal fluid pumps predetermined for injecting amounts of drugs, medications, or other liquids. The connector of the present invention allows for organized and controllable delivery and administration of a wide variety of medications and pharmaceutical agents with a minimal amount of medication intermixing prior to entry into a body.
The mixing connector forms the male half of a luer lock connector. The mixing connector has a size equal to the medical industry standard for insertion into a vascular access device. The term “standard,” as it is used herein, relates to the industry standard corresponding to ISO 594-1:1986.
When used with the multi-lumen intravenous extension of the '167 Patent, the connector of the present invention replaces the connector 32, which is positioned between the intra-vascular or intravenous access site and the multi-lumen intravenous extension 12.
The Coanda Effect, also known as “boundary layer attachment”, is the tendency of a stream of fluid to stay attached to a convex surface, rather than follow a straight line in its original direction even if the surface's direction of curvature is directed away from the axis of the stream of fluid. The mixing connector of the invention utilizes the Coanda Effect when directing the stream of liquids exiting a multi-lumen interface (such as the distal end 30). In particular, the fluids exiting secondary lumens that are disposed adjacent the inner wall of the mixing connector will travel along that surface and remain substantially coherent along the convex surface with little or no mixing with the fluid exiting the primary lumen or other fluid(s) exiting secondary lumen(s). This laminar flow is maintained most or all of the way through the mixing connector. It can be appreciated that this laminar flow is enhanced when guiding fins project inwardly from the surface over which the fluids travel. The mixing connector contains features to take advantage of the Coanda Effect. In this way, different medications can be kept separate, independent of carrier flow rate and boluses. Because differing drugs are sometimes incompatible, e.g., due to differing drug solubilities that can cause undesirable precipitant or can cause drug inactivation, it is desirable to keep the drugs separate before introduction into a patient. Such separation is important to drugs like Dilantin/phenytoin, which precipitates when piggybacked into any dextrose-containing solution. The phenomenon relates, often, to the solute and the solvent (pH, concentration, temperature in solution, protein binding, etc.). Amphotericin B (Fungizone) similarly precipitates with solutions containing sodium chloride and Dopamine (Intropin, Revimine) is inactivated in solutions with a high pH and must not be piggybacked into any solution containing sodium bicarbonate. The mixing connector of the invention reduces the possibility of drug incompatibility to a point where mixture and common exposure is substantially eliminated and the possibility of drug precipitation is minimized.
The mixing connector can be used in a number of medical applications, such as with delivery of anesthesia during operations. The mixing connector allows for infusion of anesthetic agents, vaso-active agents, antibiotics, and antiarrhymics, whether in adults or children (both neonatal and pediatric) and can be used with a patient controlled analgesia (PCA) pump. Also, the mixing connector can be used in an intensive care unit for vaso-active medications, antiarrhymics, potassium, antibiotics, insulin, etc.
The '167 Patent describes an over-pressure danger that exists at a vascular entry point when fluid is being introduced into a patient. As can be understood from the description of the mixing connector herein, replacement of the '167 connector 32 with the mixing connector does not adversely impact the over-pressure protection that exists when the mixing connector is utilized with the '167 system 10 and, therefore, is particularly suited for improving that system 10.
Because turbulence of the intermixed fluids at the mixing connector is minimized, all of the advantages provided by the '167 system remain with the connector of the present invention. More specifically, delivering the pharmaceutical agents with less change to the normal fluid dynamics improves patient safety as compared to prior art infusion systems. Additionally, the infusion of liquid agents through the satellite lumens remains independent upon carrier fluid rates for delivery. Because the liquids from the satellite lumens are delivered with greater control in volume, time of onset of the action of the agents delivered is decreased and the concentration of those agents remains virtually constant. Less intermixing of the fluids also means that delivery of the agents infused through the satellite lumens will not be altered by the carrier fluid rate. Like the '167 system, the mixing connector decreases priming volume even more by further reducing the “tubing dead space.” The mixing connector also allows and enhances independent infusion of multiple agents and reduces carrier fluid rate requirements.
Other features that are considered as characteristic for the invention are set forth in the appended claims.
Although the invention is illustrated and described herein as embodied in a turbulence minimizing device for multi-lumen fluid infusing devices and a method for minimizing turbulence in such systems, it is, nevertheless, not intended to be limited to the details shown because various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.
The construction and method of operation of the invention, however, together with additional objects and advantages thereof, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawing.
In the following, the invention will be described in more detail by exemplary embodiments and the corresponding figures. By schematic illustrations that are not true to scale, the figures show different exemplary embodiments of the invention. The same or equally functioning parts are characterized with the same reference numerals. Shown are sections in schematic cross-section.
As shown in
Referring now to the drawings in greater detail, there is illustrated in
The connector 100 has an outer diameter that can be of a standard size to fit multi-lumen supply lines such as the three-lumen configuration 18, 26, 27 illustrated in
The body of the connector 100 defines an interior chamber 110 having two parts, a proximal connection portion 120 and a distal intermixing portion 130.
The proximal connection portion 120 has a substantially cylindrical interior cavity 122 for receiving therein one or more of the fluid supplying lumens, for example, the primary and secondary lumens 18, 26, 27 illustrated in
The interface between the proximal cavity 122 and the distal intermixing portion 130 can include a limiting shelf 124 having an internally projecting radial extent less than or equal to a distance D between the outer circumference of the distal end of the multi-lumen tube assembly and the radially outer-most edge of an opening of any of the lumens within the distal end 140. For example, if there is a distal end 140 with three lumens aligned along a single diameter as shown in
The distal intermixing portion 130 is the downstream portion of the chamber 110. This region receives the fluids that exit the fluid supplying lumens. In one exemplary embodiment illustrated in
Consistent with the Coanda Effect, the fluids exiting secondary lumens that are disposed adjacent the inner wall 132 of the funnel will travel along that surface and remain substantially coherent along the inwardly curved/slanted wall 132 with little or no mixing with the primary lumen fluid (or other secondary fluids). This laminar flow is maintained due to the streamlining (described as the Coanda Effect above) that is created by the wall 132 of the proximal intermixing portion 130 from the lumen exit to the bore 106.
It can be appreciated that laminar flow can be enhanced if guiding fins 134 project inwardly from the inner wall 132. Such fins 134 are illustrated, first, within the distal cavity 132 of the connector 100 illustrated in
In the exemplary embodiment of
The fins 134 have differing configurations depending upon the spatial orientation of the primary and secondary lumens. FIGS. 6 to 13 illustrate various exemplary configurations of the fins 134 within the distal cavity 132 numbering fins from 2 to 6. Of course, manufacturing limitations and needs of the user will determine whether or not a given number of fins 134 is practical for the desired use.
The interior edges of the fins 134 can be sharpened with a beveled edge 136 like a knife to improve segregation and decrease turbulence thereat. Such an embodiment is shown, for example, in
Each of the fins 134 in FIGS. 6 to 11 and 13 are illustrated as being disposed to a side of a secondary lumen. If desired, one or more fins 134 can bisect one or more of the secondary lumens.
The shape of the sides of the fins 134 can take many forms, triangular, rectangular, polygonal, blade- or knife-shaped, and/or a combination of one or more shapes.
In the fins 134 extend all the way to the distal surface 146 of the distal end 140 of the fluid supplying lumens, then the fins 134 can abut the distal surface 146 (as shown at the lower of the two fins 134 of
FIGS. 14 to 16 illustrate another alternative embodiment of a connector 200 of the present invention.
The desired orientation of the multi-lumens with respect to the fins 134, 234, 334, may require exact placement of the distal end 140 of the multiple lumens. Exact rotational orientation can be assured by providing at least one recess on the exterior surface of the distal end 140 of the multi-lumen plug that is to be inserted into the proximal cavity 132, 232, 332 of the connector 100, 200, 300. If the proximal cavity 132, 232, 332 is provided with at least one protrusion extending radially inward into the center of the cavity 132, 232, 332, then the distal end 140 of the lumens to be inserted therein will not occur unless the protrusion is aligned with the recess—much like a key and keyhole. Of course, this configuration can be reversed if desired. If only one recess and only one protrusion is provided according to such a configuration, then the distal end 140 cannot enter the proximal cavity 132, 232, 332 except in proper rotational alignment. An example of this single recess/protrusion assembly 400 is illustrated in the cross-section of
The protrusion on the inside of the chamber 132, 232, 332 can be displayed to the user, if desired, in directions for use or can be permanently marked on the connector 100, 200, 300.
There are many kinds of luer connector fittings that can be used with the connector 100, 200, 300. Only a few exemplary embodiments are illustrated in the figures of the drawings and, therefore, the possible luer fittings should not be limited to that which is shown. The fittings typically include round male and female interlocking tubes, slightly tapered to hold together better with a simple pressure or twist fit, referred to in the art as a luer slip and a luer lock. In the latter configuration, an outer threading rim improves the secure, fluid-tight connection of the luer connector.
One advantage to each of the above-mentioned configurations over the '167 device is that the volume of the intermixing chamber 132, 232, 332 is smaller than the pill-shaped chamber 32. Therefore, the amount of medicinal fluid necessary to fill the chamber 132, 232, 332 is reduced, thereby, decreasing the time for any injectate to exit the connector and enter the catheter 34. Also the volume of priming/flushing fluids is reduced as well as the time taken to prime or flush.
The connector 100 of the present invention can be used in a number of medical applications. For example, it can be used in anesthesia during operations for infusion of anesthetic agents, vaso-active agents, antibiotics, and antiarrhymics, whether in adults or children (both neonatal and pediatric). The connector 100, 200, 300 also can be used with a PCA pump and can be used in an intensive care unit for vaso-active meds, antiarrhymics, potassium, antibiotics, insulin, etc.
The '167 Patent describes an over-pressure danger that exists at a vascular entry point when fluid is being introduced into a patient. As can be understood from the description of the connector 100, 200, 300, replacement of the '167 connector 32 with the connector 100, 200, 300 does not adversely impact the over-pressure protection that exists when the connector 100, 200, 300 is utilized with the '167 system 10 and, therefore, is particularly suited for improving that system 10.
Because turbulence of the intermixed fluids at the connector 100, 200, 300 is minimized, all of the advantages provided by the '167 system remain with the connector 100, 200, 300. More specifically, delivering the pharmaceutical agents with fewer changes to the normal fluid dynamics improves patient safety as compared to prior art infusion systems. Additionally, the infusion of liquid agents through the satellite lumens remains independent of carrier fluid rates for delivery. Because the liquids from the satellite lumens are delivered with greater control in volume, the time of the onset of the action of the agents delivered is decreased and the concentration of those agents remains virtually constant. Less intermixing of the fluids also means that delivery of the agents infused through the satellite lumens will not be altered by the carrier fluid rate. Like the '167 system, the connector 100, 200, 300 of the present invention decreases priming volume even more by further reducing the “tubing dead space.” The connector 100, 200, 300 also allows and enhances independent infusion of multiple agents and reduces carrier fluid rate requirements.
From the foregoing description, it will be appreciated that the connector of the present invention provides a number of advantages, some of which have been described above and others of which are inherent in the invention.
This application claims the priority, under 35 U.S.C. § 119, of U.S. Provisional Patent Application No. 60/851,035 filed Oct. 11, 2006, the entire disclosure of which is hereby incorporated herein by reference in its entirety.
Number | Date | Country | |
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60851035 | Oct 2006 | US |