The present disclosure relates to the field of infusion devices and methods of using such devices, and more particularly to intravenous (IV) catheters and methods of using such catheters.
Several types of medical therapies involve inserting a catheter into a patient's blood vessel and delivering treatment fluids into the patient's vasculature through the catheter. Catheter access to the vessel is generally accomplished through venipuncture, in which a catheter is disposed coaxially over a needle, and moves with the needle as it penetrates and is advanced through the patient's tissue so that eventually the needle and catheter distal tip are disposed within the patient's blood vessel. The needle can then be removed while the catheter distal tip remains in place, providing a conduit for fluid delivery.
A variety of fluids can be delivered to the patient's vasculature through the catheter. For example, fluids infused through catheters range from simple saline solutions to various medicaments to total parenteral nutrition. Such catheters can also be used to withdraw blood from the patient and/or to monitor various parameters of the patient's vascular system.
In some clinical circumstances it is desired to inject large quantities of fluid rapidly through the catheter and into the patient. For example, in some diagnostic imaging procedures, a “power injector” pump is used to inject viscous contrast media at a high flow rate to establish a contrast bolus or plug of contrast media in the bloodstream of the patient in order to enhance image quality. Also, in rapid infusion therapies, pressurized fluids are delivered through a catheter so that such fluid is delivered at a higher flow rate than in traditional infusion therapy. In such circumstances, increased backpressure can be expected in the infusion equipment and catheter assembly.
The catheter is often tapered at its distal tip in order to better facilitate the venipuncture process. A non-tapered catheter has increased risk of being snagged on tissues, thus increasing discomfort for the patient, and possibly fully or partially blocking the catheter from accompanying the needle into the blood vessel, which could result in a failed venipuncture attempt. In embodiments in which the catheter lumen is also tapered at the distal tip, the pressurized fluid may be accelerated as it exits the catheter, which can be undesirable. Some infusion catheters have apertures formed through a side wall of the catheter at or near the distal tip. Such apertures increase the delivery area, and can reduce exit flow speed and backpressure in the system. However, such apertures increase the risks of the catheter becoming snagged on tissue during insertion.
Catheters having one or more apertures formed through a side wall of the respective catheter at or adjacent its distal tip are disclosed, which one or more apertures are configured to avoid snagging on patient tissues during the insertion process, such as during venipuncture.
In accordance with one embodiment, a catheter assembly is provided comprising a catheter tube attached to a catheter hub. The catheter tube can comprise an elongated body defining a lumen, a distal tip defining a distal opening communicating with the lumen; and a tapered portion at and adjacent the distal tip. The tapered portion can comprise a dissolvable part and a non-dissolvable part
In accordance with another embodiment, the present invention provides a catheter assembly with a tubular catheter, which may simply be referred to as a catheter. The catheter comprises an elongated body defining a lumen, a distal tip defining a distal opening communicating with the lumen; and a tapered portion at and adjacent the distal tip. The tapered portion can comprise a dissolvable part and a non-dissolvable part.
In some such embodiments, surfaces of the non-dissolvable part and dissolvable part can be aligned so that the tapered portion has a smooth surface spanning both the non-dissolvable part and the dissolvable part. In other such embodiments, the non-dissolvable part can define the distal tip and extends from the distal tip to the elongated body. A hole can be formed through the non-dissolvable part proximal of the distal tip, and the dissolvable part can fill the hole.
In another embodiment, the non-dissolvable part can define a plurality of fingers, and the dissolvable part can be disposed between the fingers. In some such embodiments the fingers can be biased to a non-tapered configuration. The dissolvable part can hold the fingers in a tapered configuration so as to form the tapered portion. In yet further embodiments, the dissolvable part can define an outer surface of the distal tip about an entire circumference of the distal tip so that at least a portion of the fingers are covered by the dissolvable part.
In yet another embodiment, a flow rate of fluid through the catheter is greater when the dissolvable part has dissolved.
In some embodiments, the fingers can be biased outwardly relative to the elongated body. In other embodiments, the fingers can be integral with the elongate body.
In still further embodiments, the distal opening can have a first diameter, and the lumen can have a second diameter greater than the first diameter. In yet additional embodiments, the non-dissolvable part can comprise a lattice structure, and the lattice structure can support the dissolvable part.
In accordance with another embodiment, a method of delivering medical fluids is provided. The method includes advancing a distal tip of a catheter into a patient blood vessel. The catheter can have an elongated body defining a lumen. The distal tip can have a non-dissolvable part defining a primary exit opening aligned with an axis of the elongated body and communicating with the lumen, and a secondary exit opening formed through a side wall of the catheter and communicating with the lumen. A dissolvable part of the distal tip can cover the secondary exit opening. The dissolvable part of the catheter distal tip can be allowed to dissolve while within the patient's body so that the secondary exit opening is uncovered. The medical fluid can be delivered through the catheter primary and secondary exit openings after the dissolvable part has dissolved.
In some such embodiments, the primary and secondary exit opening can present a fluid exit area greater than the primary exit opening taken alone.
In additional embodiments, the secondary exit opening can be spaced from the primary exit opening.
In further embodiments, the primary and secondary exit openings can be contiguous with one another.
In yet further embodiments, the non-dissolvable part can define a plurality of fingers, and the dissolvable part can be disposed between the fingers.
In still further embodiments, the fingers can be held deflected radially inwardly by the dissolvable part, and when the dissolvable part dissolves, the fingers can move radially outwardly to a natural, at-rest position.
Yet another aspect of the present disclosure is a method of manufacturing a catheter assembly. The method can comprise: forming a catheter tube and attaching the catheter tube to a catheter hub; framing a tapered portion at a distal end of the catheter tube and terminating the distal end with a primary opening; forming an inchoate secondary opening with a dissolvable part adjacent the primary opening; and projecting a needle with a needle tip through the catheter tube so that a needle tip extends distal of the distal end of the catheter tube.
The method wherein the primary opening and the secondary opening when the dissolvable part dissolves can present a combined fluid exit area greater than the primary opening taken alone.
The method wherein the secondary opening can be spaced from the primary opening.
The method wherein the primary and secondary openings can be contiguous with one another.
The method wherein the primary opening can form with a non-dissolvable part and wherein the non-dissolvable part can define a plurality of fingers, and the dissolvable part can be disposed between the fingers.
The method wherein the fingers can be held deflected radially inwardly by the dissolvable part, and when the dissolvable part dissolves, the fingers can move radially outwardly to a natural, at-rest position.
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Preferably the plug 40 is sufficiently thick so as to maintain strength to withstand the venipuncture without failing or degrading, but sufficiently thin so that the plug 40 dissolves relatively quickly. For example, it is desired that the plug 40 dissolve in a very short time, such as within a few minutes of the catheter tip 22 entering the bloodstream. Different compounds and materials may be used in various thicknesses and percent to vary the dissolve time. Preferably the rest of the catheter is made of a material that is not substantially resorbable. Once the plug 40 has dissolved, the secondary opening 30 is available (along with the distal opening 26) for delivery of fluids F, such as contrast or other therapeutic fluids, and the fluid delivery flow rate potential of the catheter 20 can be substantially increased. More specifically, provision of secondary openings reduces fluid exit speed for a particular fluid flow delivery rate when compared to fluid exit speeds for an equivalent catheter having only the traditional distal opening 26. Thus, an aspect of the present disclosure is understood to include a catheter assembly comprising a catheter tube attached to a catheter hub and wherein the catheter tube comprises a distal opening and a side opening to permit outflows or inflows through the catheter tube from at least two different openings. The distal opening may be referred to as a first opening and the side opening may be referred to as a second opening. As disclosed in this embodiment, the side opening is an inchoate opening that forms a complete opening adequate for fluid flow following a short period to permit a plug to dissolve to form the second opening. Additional side inchoate openings, such as second or third side openings, may be incorporated each with a plug that is dissolvable.
In the illustrated embodiment the secondary opening 30 is formed in the tapered portion 24 of the catheter 20 adjacent the distal tip 22. It is to be understood that other embodiments may employ multiple secondary openings in the tapered portion 24, in the non-tapered body portion 25 proximal of the tapered portion 24, or both.
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In the illustrated embodiment, surfaces such as the leading surface 34 and the inclined proximal surface 38 can provide support for the resorbable plug 40, helping maintain the plug 40 in place during formation of the plug, insertion of the catheter during venipuncture, and for a portion of the time it takes for the resorbable material to dissolve. It is to be understood that other aperture structures can be provided to help support the plug. For example, in still other embodiments the secondary opening can include a lattice or mesh structure that helps to support the plug 40, but still enables fluid flow once the plug has dissolved. The plug may be formed by placing a stem inside the lumen of the catheter tube and coating or spraying the secondary opening 30 with a biocompatible material that dissolves when come in contact with body fluids.
Resorbable materials that are believed to be usable to implement the present catheter tubes with both a dissolvable part and a non-dissolvable part include, without limitation, Polylactides (PLA), Polyglycolides (PGA), Polycaprolactones (PCL), Polydioxanone (PDS), poly(lactide-co-glycolide) (PLGA), Poly vinyl pyrrolidone (PVP), Trimethylcarbonate (TMC), and Copolymer blends of these materials. Poly(esters) based on polylactide (PLA), polyglycolide (PGA), polycaprolactone (PCL), and their copolymers are known to have been employed as biomaterials. Degradation of these materials yields the corresponding hydroxy acids, making them safe for in vivo use. Other bio- and environmentally degradable polymers include poly(hydroxyalkanoate)s of the PHB-PHV class, additional poly(ester)s, and natural polymers, e.g., hyaluronan and particularly, modified poly(saccharide)s, e.g., starch, cellulose, and chitosan.
For other catheter assemblies and assembly components disclosed herein below, such as for other catheter tubes, it is understood that where a feature is shown but not expressly described and is otherwise the same or similar to the feature or features described elsewhere, such as above with reference to
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In the illustrated embodiment the distal portion 50 defines the entire outer surface of the tapered distal tip 24, and the fingers 60 are substantially or completely covered by the dissolvable portion 50. Of course, parts of the dissolvable portion can extend into and through the spaces 62 between the fingers 60. After the catheter 20 is placed in the patient's blood vessel, the dissolvable portion will dissolve, freeing the fingers to return to their natural position, which in the illustrated embodiment is splayed outwardly relative to the catheter body 25.
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Once the catheter is positioned in the blood vessel, the dissolvable portion will dissolve, leaving the catheter 20 with the lattice structure 70 as depicted in
The embodiments discussed above have disclosed structures with substantial specificity. This has provided a good context for disclosing and discussing inventive subject matter. However, it is to be understood that other embodiments may employ different specific structural shapes and interactions. Also, although embodiments discussed herein have been disclosed as appropriate for high pressure and flow rates (i.e., over 1 L/hr) associated with rapid infusion, it is to be understood that the principles discussed herein can be employed with catheter assemblies intended for more traditional, relatively low infusion flow rates (i.e., under 1 L/hr). Further, embodiments employing a resorbable material can be used at high or low infusion flow rates, or even when there is very little or no fluid flow or back pressure.
In some preferred embodiments, during use of any of the above-described structural embodiments and variations thereof, after venipuncture, the clinician will wait a period of time before beginning infusion in order to provide time for the resorbable material to at least partially (and preferably substantially completely) dissolve. Depending on the resorbable material, such wait times can be from a few seconds to a few or several minutes. In some other embodiments, infusion at low flow rates can begin while the resorbable material is dissolving, and flow rates can be increased over time as dissolving becomes more complete.
Methods of making and of using the various catheter assemblies and there components are understood to be within the scope of the present disclosure.
Although inventive subject matter has been disclosed in the context of certain preferred or illustrated embodiments and examples, it will be understood by those skilled in the art that the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof In addition, while a number of variations of the disclosed embodiments have been shown and described in detail, other modifications, which are within the scope of the inventive subject matter, will be readily apparent to those of skill in the art based upon this disclosure. For example, the principles discussed herein may be practiced in catheters used in clinical treatments outside the patient's bloodstream. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the disclosed embodiments may be made and still fall within the scope of the inventive subject matter. For example, in some embodiments having features resembling the embodiments illustrated in
The application claims priority to U.S. Provisional Application No. 61/932,390, which was filed on Jan. 28, 2014, the entirety of which is hereby incorporated by reference.
Number | Date | Country | |
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61932390 | Jan 2014 | US |