Briefly summarized, embodiments disclosed herein are directed to a stem configured to provide fluid communication between a catheter and a medical device (e.g. a port). The stem includes optimized geometry configured to maximize fluid flow through the stem lumen, while facilitating engagement with a lumen of the catheter.
Coupling catheters, or similar compliant tubular devices, with rigid stems, e.g. a port stem or the like, can be a challenging process especially within the confined, wetted environment of subcutaneous placements. Typically, the stem is urged into the lumen of the catheter, and the compliant catheter elastically deforms to engage the stem in an interference fit. Optionally a cathlock can further secure the catheter to the port stem to prevent fluid leakage. The relative sizes of the inner diameter of the catheter lumen, and the outer diameter of the stem can be critical. Where a stem tip outer diameter is too large, coupling the catheter to the stem can be challenging, leading to kinking or collapsing of the catheter. Where the stem tip outer diameter is too small, a corresponding inner diameter of the stem lumen restricts fluid flow therethrough. Further, thinner catheters (i.e. lower French size catheters) have relatively thinner walls, making the catheter more susceptible to kinking or collapse.
Disclosed herein is a stem for providing fluid communication between an access port and a catheter, the stem including an elongate body defining a body lumen, a distal opening of the body lumen having a first diameter, and a tip structure extending distally from the distal opening and having a tip lumen having a second diameter smaller than the first diameter, and a plurality of slots extending from a distal end of the tip structure to the distal opening of the body lumen.
In some embodiments, the plurality of slots define a plurality of fingers. In some embodiments, the plurality of fingers taper from a first wall thickness at a proximal end to a second wall thickness, less than the first wall thickness, at a distal end. In some embodiments, the tip structure comprises an outer surface that tapers distally from a first larger diameter to a second smaller diameter. In some embodiments, the elongate body comprises a circumferential ridge disposed along an outer surface of the elongate body.
In some embodiments, the stem is coupled to the access port with one of an interference fit, press-fit, or snap-fit engagement. In some embodiments, the slot extends through an arc distance of less than 350°. In some embodiments, a finger of the plurality of fingers extends radially through an arc distance of less than 350°.
Also disclosed is a stem for providing fluid communication between a medical device and a catheter including, a body defining a lumen extending between a proximal opening and a distal opening, the distal opening defining a first diameter, a tip structure disposed at a distal end of the body having, one or more fingers extending radially inwards and distally from the distal opening, an inner surface of a first finger of the one or more fingers extending along an axis disposed radially inward from the distal opening.
In some embodiments, the first finger extends radially through an arc distance of less than 350°. In some embodiments, the finger includes a proximal portion extending from the distal opening radially inward and distally, and a distal portion supported by the proximal portion and extending distally therefrom. In some embodiments, an inner surface of the distal portion extends parallel to the longitudinal axis and an outer surface of the distal portion extends at an angle relative to the longitudinal axis.
In some embodiments, the stem further includes a second finger of the plurality of fingers and disposed at a different radial position about the axis of the lumen, an inner surface of the first finger and an inner surface of the second finger defining a second diameter that is less than the first diameter. In some embodiments, an outer surface of the first finger and an outer surface of the second finger defines a tapered outer profile extending from the second diameter to the first diameter. In some embodiments, the first finger and the second finger define a slot extending longitudinally therebetween to the distal opening. In some embodiments, the slot extends radially through an arc distance of less than 350°.
Also disclosed is a method of coupling a catheter with a medical device including, providing a stem formed of a rigid material and defining a lumen extending between a distal opening and a proximal opening, the distal opening defining a first diameter, the stem having a distal tip structure including two or more fingers extending longitudinally distally from the distal opening, distal tip of the two or more fingers co-operating to form a second diameter, less than the first diameter, providing a catheter formed of a compliant material and defining a lumen having a third diameter that is larger than the second diameter, urging the tip structure into the catheter lumen, and elastically deforming the catheter from the third diameter to the first diameter.
In some embodiments, the third diameter of the catheter lumen is equal to or less than the first diameter of the distal opening. In some embodiments, a finger of the two or more fingers includes a proximal portion extending radially inward from the distal opening, and a distal portion extending longitudinally distally from the proximal portion and defining the inner surface. In some embodiments, an outer surface of the two or more fingers defines a tapered profile extending proximally from the second diameter to the first diameter. In some embodiments, the two or more fingers define a slot extending longitudinally therebetween from a distal tip of the tip structure and the distal opening.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.
With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.
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Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
Embodiments described herein are directed to a stem 100 including tip geometry configured to facilitate coupling a catheter 90, or similar compliant tube, with the stem 100 while maximizing fluid flow therethrough.
The catheter 90 can include an elongate tube extending longitudinally and defining a catheter lumen 92. In an embodiment, a distal tip of the catheter 90 can be disposed within a vasculature of the patient to provide fluid communication therewith. A proximal end of the catheter 90 can be coupled with the stem 100, as described in more detail herein. It will be appreciated that the catheter 90 is not intended to be limiting, and that embodiments disclosed herein can be used with various compliant, tubular devices configured to provide fluid communication. The catheter 90 can be formed of a compliant material such as a plastic, polymer, elastomer, composite, or the like. A proximal end of the catheter 90 can be configured to elastically deform and stretched over the stem 100 to provide a fluid tight seal therebetween. As will be appreciated, the exemplary environment of use is not intended to be limiting and embodiments described herein can be used with various medical tube couplings that include a compliant tube coupling with a rigid structure and require a fluid tight seal therebetween while maximizing fluid throughflow.
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In an embodiment, the stem 100 can include one or more ridges 110 extending circumferentially about the central axis 80 and disposed along an outer surface of the stem 100. The ridge 110 can define a rounded, triangular, stepped, or barbed longitudinal profile and define an increase in outer diameter of the stem 100. The ridge 110 can be configured to increase friction between the stem 110 and a catheter 90, when engaged therewith, to facilitate gripping the catheter 90 in an interference fit.
In an embodiment, the ridge 110 can be configured to facilitate coupling a cathlock with the stem 100 and catheter 90 assembly. For example, with the catheter 90 engaged with an outer surface of the stem 100, a cathlock can engage an outer surface of a portion of the catheter 90 and compress the catheter 90 thereto, further securing the catheter 90 thereto. The cathlock can include a corresponding abutment extending radially inward and configured to engage the ridge 110, optionally through the catheter 90, in a snap-fit or interference fit engagement. In an embodiment, the cathlock can engage the port 50 in a press-fit, snap-fit, or interference fit engagement.
In an embodiment, the stem 100 can include a proximal engagement portion 106 disposed adjacent the proximal opening 116. The engagement portion 106 can define a substantially cylindrical shape, extending longitudinally and defining a diameter (d4). The engagement portion 106 can be configured to engage the port 50 in a press-fit or interference-fit engagement. In an embodiment, the engagement portion 106 can include one or more protrusions, detents, pawls, ridges, barbs, or the like, configured to engage the port 50 in a snap-fit engagement. A proximal rim of the engagement portion 106 can define a beveled or chamfered edge to facilitate engagement with the port 50. In an embodiment, a diameter (d4) of the engagement portion 106 can be the same or slightly larger than a diameter of a stem receiving recess disposed in the port 50.
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In an embodiment, the stem lumen 102 can define a discontinuous change in diameter along the longitudinal length thereof. For example, as shown in
In an embodiment, the proximal opening 116 can include a beveled edge configured to facilitate a fluid flow into, or out of, the lumen 102 and minimize fluid flow turbulence. In an embodiment, a diameter of the proximal opening 116 can be the same as, or different from the diameter (d1) of the distal opening 114. In an embodiment, the diameter of the proximal opening 116 can be larger or smaller than the first diameter (d1) of the distal opening 114.
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In an embodiment, an inner surface 126 of the one or more fingers 120, e.g. a first inner surface 126A and a second inner surface 126B, can co-operate to define a lumen 108 of the tip structure 104 defining a second diameter (d2). In an embodiment, a distal tip 132 of the one or more fingers 120 can co-operate to define a second diameter (d2). In an embodiment, the second diameter (d2) can be less than the first diameter (d1). As shown in
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Advantageously, embodiments of the tip structure 104 can engage an inner surface of the catheter lumen 92, to facilitate coupling the catheter 90 with the stem 100, while mitigating any reduction in fluid flow relative to the diameter (d1) of the distal opening 114. For example, as shown in
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In an embodiment, the cross-sectional area of the second fluid flow 72 through the distal tip structure 104 (
In an embodiment, a catheter lumen diameter (d3) can be larger than a first diameter (d1) of the distal opening 114. As such, when engaging the stem 100 with the catheter lumen 92, the distal tip structure 104 can extend into the catheter lumen 92 without the catheter 90 elastically deforming. When the catheter lumen 92 engages the outer surface of the stem 100, i.e. at a point where the outer surface of the stem 100 matches the inner lumen diameter (d3), an axial force is required to elastically deform the catheter 90 to fit over the stem 100 and engage therewith in an interference fit. Advantageously, the tip structure 104 extending into the catheter lumen 92 can provide columnar support to the compliant catheter 90, as the axial force is applied. As such, the distal tip structure 104 can mitigate kinking of the catheter 90, facilitating engagement therewith, while have little to no impact of fluid throughflow, as described herein.
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While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/040715 | 7/7/2021 | WO |