Optimized port stem geometry
The optimized stem geometry with a deformable tip structure addresses the challenges of kinking and fluid flow in catheter-stem coupling, ensuring secure engagement and consistent fluid flow across various catheter sizes.
Patent Information
- Application Number
- JP2024500288
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-07-07
- Publication Date
- 2025-10-20
- Estimated Expiration
- 2041-07-07
AI Technical Summary
Mating a catheter or similar compliant tubular device to a rigid stem, such as a port stem, is challenging due to issues like kinking or collapse, especially in a narrow, moist subcutaneous environment, and existing designs often compromise fluid flow or engagement stability.
A stem with an optimized geometry featuring a distal tip structure having fingers and slots that elastically deform to fit within the catheter lumen, providing a secure engagement while maintaining fluid flow, using materials like plastic, polymer, or metal, and incorporating features like ridges for additional stability.
The optimized stem geometry facilitates secure coupling of the catheter to the port stem, reducing kinking and maintaining fluid flow rates, while allowing for a wide range of catheter sizes and minimizing product inventory needs.
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Abstract
Description
[Technical Field]
[0001] The present disclosure relates to optimized port stem geometry. Summary of the Invention
[0002] 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 an optimized geometry configured to maximize fluid flow through the stem lumen while facilitating engagement with the lumen of the catheter.
[0003] Mating a catheter or similar compliant tubular device to a rigid stem, such as a port stem, can be a challenging process, especially within the narrow, moist environment of subcutaneous placement. Typically, the stem is biased into the catheter lumen, and the compliant catheter elastically deforms to engage the stem with an interference fit. Optionally, a caslock 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 important. If the stem tip outer diameter is too large, it can be difficult to couple the catheter to the stem, leading to kinking or collapse of the catheter. If the stem tip outer diameter is too small, the corresponding inner diameter of the stem lumen restricts fluid flow through the stem lumen. Furthermore, thinner catheters (i.e., catheters with smaller French sizes) have relatively thin walls, making the catheter more susceptible to kinking or collapse.
[0004] 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, the body lumen having a distal opening having a first diameter, and a tip structure extending distally from the distal opening, the tip structure 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.
[0005] 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 at a distal end that is thinner than the first wall thickness. 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 the outer surface of the elongate body.
[0006] In some embodiments, the stem is coupled to the access port with one of an interference fit, a press fit, or a snap fit engagement. In some embodiments, the slot extends an arc distance of less than 350°. In some embodiments, one finger of the plurality of fingers extends radially an arc distance of less than 350°.
[0007] Also disclosed is a stem for providing fluid communication between a medical device and a catheter, the stem comprising: a body defining a lumen extending between a proximal opening and a distal opening, the distal opening defining a first diameter; and a tip structure disposed at a distal end of the body, the tip structure having one or more fingers extending radially inward and distally from the distal opening, the inner surface of a first of the one or more fingers extending along an axis disposed radially inward from the distal opening.
[0008] In some embodiments, the first finger extends radially over an arcuate distance of less than 350°. In some embodiments, the finger includes a proximal portion extending radially inward and distally from the distal opening 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 to the longitudinal axis.
[0009] In some embodiments, the stem further includes a second finger of the plurality of fingers, the second finger being disposed at another radial position about the axis of the lumen, wherein the inner surface of the first finger and the inner surface of the second finger define a second diameter smaller than the first diameter. In some embodiments, the outer surface of the first finger and the outer surface of the second finger define 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 over an arc distance of less than 350°.
[0010] Also disclosed is a method of coupling a catheter to a medical device, the method including the steps of providing a stem formed from 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 and distally from the distal opening, the distal tips of the two or more fingers cooperating to form a second diameter smaller than the first diameter, providing a catheter formed from a compliant material and defining a lumen having a third diameter larger than the second diameter, biasing the tip structure into the catheter lumen, and elastically deforming the catheter from the third diameter to the first diameter.
[0011] 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, one finger of the two or more fingers includes a proximal portion extending radially inward from the distal opening and a distal portion extending longitudinally and distally from the proximal portion and defining an inner surface. In some embodiments, the outer surfaces of the two or more fingers define 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 between the two or more fingers from the distal tip of the tip structure and the distal opening.
[0012] A more particular description of the present disclosure will be given by reference to specific embodiments thereof that are illustrated in the accompanying drawings. It will be understood that these drawings depict only typical embodiments of the invention and therefore should not be considered as limiting the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]
[0013] [Figure 1] 1 shows a perspective view of a stem including an optimized tip geometry in an exemplary use environment according to an embodiment disclosed herein. FIG. [Figure 2A] FIG. 1 shows a perspective view of a stem including an optimized tip geometry according to an embodiment disclosed herein. [Figure 2B] FIG. 1 shows a side view of a stem including an optimized tip geometry according to an embodiment disclosed herein. [Figure 2C] 1 shows a longitudinal cross-sectional view of a stem including an optimized tip geometry according to an embodiment disclosed herein. [Figure 2D] 2D shows an enlarged detail of the stem of FIG. 2C according to an embodiment disclosed herein. [Figure 3A] 1 shows a distal end view of a stem according to an embodiment disclosed herein. [Figure 3B]1 shows a distal end view of a stem according to an embodiment disclosed herein. [Figure 3C] 1 shows a longitudinal cross-sectional view of a stem according to an embodiment disclosed herein. [Figure 3D] 3D shows a distal end view of the stem of FIG. 3C according to an embodiment disclosed herein. [Figure 4A] 10 illustrates an exemplary use of a stem including an optimized tip geometry according to embodiments disclosed herein. [Figure 4B] 10 illustrates an exemplary use of a stem including an optimized tip geometry according to embodiments disclosed herein. [Figure 5A] 1 shows an enlarged detail of a longitudinal cross section of a stem according to an embodiment disclosed herein. [Figure 5B] 5B shows a transverse cross-sectional view of the stem of FIG. 5A according to an embodiment disclosed herein. [Figure 5C] 1 shows an enlarged detail of a longitudinal cross section of a stem according to an embodiment disclosed herein. [Figure 5D] 5D shows a transverse cross-sectional view of the stem of FIG. 5C according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE INVENTION
[0014] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that are readily separable from the specific embodiment and that can optionally be combined with or substituted for features of any of the other numerous embodiments disclosed herein.
[0015] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and 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 within a group of features or steps and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," "back," etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "the" include plural references unless the context clearly dictates otherwise.
[0016] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.
[0017] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near or within a patient when the catheter is used with the patient. Similarly, for example, the "distal length" of a catheter includes a length of the catheter intended to be near or within a patient when the catheter is used with the patient. For example, the "distal end" of a catheter includes an end of the catheter intended to be near or within a patient when the catheter is used with the patient. Although the distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.
[0018] To aid in illustrating the embodiments described herein, as shown in Figures 1-2A, a longitudinal axis extends substantially parallel to the axial length of the stem 100. A lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and lateral axes. As used herein, a horizontal plane extends along the lateral and longitudinal axes. A vertical plane extends perpendicular to the horizontal plane.
[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Embodiments described herein are directed to a stem 100 including a tip geometry configured to facilitate coupling of a catheter 90 or similar compliant tube to the stem 100 while maximizing fluid flow. FIG. 1 illustrates the stem 100 including the optimized geometry in an exemplary use environment. In one embodiment, the stem 100 may be configured to provide fluid communication between the catheter 90 and a medical device, such as a port 50. The port 50 may generally include a body 52 defining a reservoir 54 in fluid communication with a lumen 102 of the stem 100. The port 50 may further include a needle-penetrable septum 56 disposed over the reservoir and configured to provide access to the reservoir. In use, an access needle may extend percutaneously through the needle-penetrable septum 56 into the reservoir 54 to provide fluid communication with the reservoir 54. It will be appreciated that port 50 is a non-limiting exemplary medical device and that the embodiments disclosed herein can be used with a variety of similar medical devices, including stems or similar structures.
[0020] The catheter 90 may include an elongate tube extending longitudinally and defining a catheter lumen 92. In one embodiment, the distal tip of the catheter 90 may be positioned within a patient's vascular system and provide fluid communication therewith. The proximal end of the catheter 90 may be coupled to a stem 100, as described in more detail herein. The catheter 90 is not intended to be limiting, and it will be understood that the embodiments disclosed herein can be used with a variety of compliant tubular devices configured to provide fluid communication. The catheter 90 may be formed from a compliant material, such as a plastic, polymer, elastomer, composite, or the like. The proximal end of the catheter 90 may be configured to elastically deform and stretch over the stem 100 to provide a fluid-tight seal between the catheter 90 and the stem 100. As will be understood, the exemplary use environment is not intended to be limiting, and the embodiments described herein can be used with a variety of medical tubing fittings, including compliant tube fittings having a rigid structure, that require a fluid-tight seal therebetween while maximizing the flow of fluid therethrough.
[0021] 2A-2D show further details of one embodiment of the stem 100. FIG. 2A shows a perspective view of the stem 100. FIG. 2B shows a side view of the stem 100. FIG. 2C shows a longitudinal cross-sectional view of the stem 100. FIG. 2D shows an enlarged detail of the distal tip structure 104 of the stem 100. In one embodiment, the stem 100 may be integrally formed with a medical device, such as the port 50. In one embodiment, the stem 100 may be formed as a separate structure (e.g., as shown in FIG. 2A) and may be coupled to the medical device using a press-fit, snap-fit, interference-fit engagement, and / or with adhesives, bonding, welding, etc. In one embodiment, the stem 100 may define a substantially rigid structure formed from a plastic, polymer, metal, alloy, composite, or similar suitable material. In one embodiment, the stem 100 may define a radially symmetrical structure extending about a central axis 80 that extends parallel to the longitudinal axis.
[0022] As shown in FIGS. 1 and 2C , in one embodiment, the stem 100 may define a lumen 102 extending longitudinally from a distal opening 114 to a proximal opening 116. In one embodiment, the distal opening 114 may define a first diameter (d1). As shown in FIG. 2C , the stem 100 may further include a tip structure 104 defining a tip lumen 108 extending distally from the distal opening 114 and having a second diameter (d2) smaller than the first diameter (d1) of the distal opening 114. In one embodiment, the inner diameter of the catheter lumen 92 in the relaxed state may define a third diameter (d3). In one embodiment, the catheter lumen diameter (d3) may be equal to or greater than the second diameter d2, as described in more detail herein. In one embodiment, the catheter lumen 92 may be elastically deformable to a diameter larger than the catheter lumen diameter (d3) in the relaxed configuration.
[0023] As shown in FIGS. 2A-2C, in one embodiment, the outer profile of the stem 100 may mirror the inner profile of the lumen 102. In one embodiment, the outer profile of the stem 100 may define a continuous or discontinuous cylindrical or tapered shape, or may include a combination thereof. In one embodiment, the outer profile of the stem 100 may include one or more transition portions defining a change in outer diameter between one or more outer diameters of the stem 100. The transition portions may include tapered or step transitions between different diameters. The step transition portions may include portions extending substantially perpendicular to the longitudinal axis.
[0024] In one embodiment, the stem 100 extends circumferentially about the central axis 80 and may include one or more ridges 110 disposed along the outer surface of the stem 100. The ridges 110 may define a rounded, triangular, stepped, or barbed longitudinal profile and define an increase in the outer diameter of the stem 100. The ridges 110 may be configured to increase friction between the stem 110 and the catheter 90 when engaged with the catheter 90, facilitating gripping the catheter 90 with an interference fit.
[0025] In one embodiment, the ridges 110 may be configured to facilitate coupling of the caslock with the assembly of the stem 100 and catheter 90. For example, with the catheter 90 engaged with the outer surface of the stem 100, the caslock may engage the outer surface of a portion of the catheter 90 to compress the catheter 90 therein and further secure the catheter 90 therein. The caslock may include a corresponding abutment that extends radially inward and is configured to engage the ridges 110, optionally through the catheter 90, in a snap-fit or interference-fit engagement. In one embodiment, the caslock may engage the port 50 in a press-fit, snap-fit, or interference-fit engagement.
[0026] In one embodiment, the stem 100 may include a proximal engagement portion 106 disposed adjacent the proximal opening 116. The engagement portion 106 may define a substantially cylindrical shape extending longitudinally and defining a diameter (d4). The engagement portion 106 may be configured to engage the port 50 in a press-fit or interference-fit engagement. In one embodiment, the engagement portion 106 may include one or more protrusions, detents, tabs, ridges, barbs, etc. configured to engage the port 50 in a snap-fit engagement. A proximal rim of the engagement portion 106 may define a beveled or chamfered edge to facilitate engagement with the port 50. In one embodiment, the diameter (d4) of the engagement portion 106 may be the same as or slightly larger than the diameter of a stem-receiving recess disposed within the port 50.
[0027] As shown in FIGS. 2C-2D , in one embodiment, the stem lumen 102 may define a cylindrical profile extending between the distal opening 114 and the proximal opening 116, i.e., the walls of the lumen 102 may extend parallel to the longitudinal axis. In one embodiment, the lumen 102 may define a continuous diameter, e.g., a first diameter (d1), along its longitudinal length. In one embodiment, the stem lumen 102 may define a tapered profile extending between the distal opening 114 and the proximal opening 116, i.e., the walls of the lumen 102 may extend at an angle relative to the longitudinal axis. In one embodiment, the lumen 102 may define a continuous change in diameter along its longitudinal length. In one embodiment, the inner diameter of the proximal opening 116 may be larger than the inner diameter of the distal opening 114, e.g., the first diameter (d1).
[0028] In one embodiment, the stem lumen 102 may define a discontinuous change in diameter along its longitudinal length. For example, as shown in FIG. 2D , the lumen 102 may include a first portion defining a first diameter (d1) disposed adjacent the distal opening 114. The lumen 102 may further include one or more second portions defining a diameter different from the first diameter (d1) of the first portion. The diameter of the one or more second portions may be larger or smaller than the first diameter (d1). Additionally, the lumen 102 may include one or more transition portions disposed between the first portion defining the first diameter (d1) and the one or more second portions defining one or more different diameters. The transition portions may be either tapered, i.e., have walls extending at an angle relative to the longitudinal axis, or stepped, i.e., have walls extending perpendicular to the longitudinal axis.
[0029] In one embodiment, the proximal opening 116 may include a beveled edge configured to facilitate fluid flow into and out of the lumen 102 and minimize turbulence in the fluid flow. In one embodiment, the diameter of the proximal opening 116 may be the same as or different from the diameter (d1) of the distal opening 114. In one embodiment, the diameter of the proximal opening 116 may be larger or smaller than the first diameter (d1) of the distal opening 114.
[0030] 2C-2D , in one embodiment, the distal opening 114 may define a continuous inner surface extending annularly about the axis 80 of the lumen 102 and may define a first diameter (d1). In one embodiment, the stem 100 may include a tip structure 104 extending distally from the distal opening 114 of the stem 100. In one embodiment, the tip structure 104 defines a tip lumen 108 having a discontinuous inner surface extending annularly about the axis 80 of the lumen 102 and may define a second diameter (d2). In one embodiment, the tip structure 104 may include one or more fingers 120 extending distally from a distal edge of the distal opening 114.
[0031] 3A-3D illustrate various configurations of a tip structure 104 including one or more fingers 120. In one embodiment, the one or more fingers 120 may be evenly spaced radially around the distal opening 114. In one embodiment, the one or more fingers 120 may be unevenly spaced radially around the distal opening 114. In one embodiment, as shown in FIG. 3A, the tip structure 104 may include four fingers 120, i.e., a first finger 120A, a second finger 120B, a third finger 120C, and a fourth finger 120D, evenly spaced radially around the distal opening 114. In one embodiment, as shown in FIG. 3B, the tip structure 104 may include two fingers 120, i.e., a first finger 120A and a second finger 120B, radially spaced around the distal opening 114. For example, the first finger 120A may be located opposite the second finger 120B across the central axis 80. 3C-3D, the tip structure 104 may include one finger 120, as described in more detail herein, although it will be understood that more or fewer fingers 120 are also contemplated.
[0032] In one embodiment, as shown in FIGS. 3B and 3D , each finger 120 may extend radially over an arc distance (θ). In one embodiment, the arc distance (θ) may be less than 360°. In one embodiment, the arc distance (θ) may be between 5° and 180°. In one embodiment, the arc distance (θ) may be between 35° and 55°. In one embodiment, the tip structure 104 may include a slot 130 extending longitudinally from the distal end of the tip structure 104. In one embodiment, two or more fingers 120 may cooperate to define the slot 130 extending longitudinally from the distal end of the tip structure 104 to the distal opening 114. In one embodiment, as shown in FIG. 3B , the slot 130 may extend radially over an arc distance (δ). In one embodiment, the arc distance (δ) may be less than 360°. In one embodiment, the arc distance (δ) may be between 5° and 180°. In one embodiment, the arc distance (δ) may be between 125° and 145°.
[0033] As shown in FIG. 2D , in one embodiment, one finger of the one or more fingers 120, for example, first finger 120A, may include a distal portion 124 extending longitudinally and supported by a proximal portion 122. The proximal portion 122 may extend from a distal edge of the distal opening 114 or from an inner surface of the distal opening 114 and may extend radially inward and distally therefrom at an angle. The distal portion 124 may be supported by the proximal portion 122 and may extend longitudinally and distally therefrom. An inner surface 126 of the distal portion 124 may extend substantially parallel to the longitudinal axis. An outer surface 128 of the distal portion 124 may extend at an angle relative to the longitudinal axis. In other words, distal portion 124 may define a first wall thickness adjacent proximal portion 122 and a second wall thickness at distal tip 132 of finger 120 that is less than the first wall thickness.
[0034] In one embodiment, the inner surfaces 126 of one or more fingers 120, e.g., first inner surface 126A and second inner surface 126B, may cooperate to define the lumen 108 of the tip structure 104, which defines a second diameter (d2). In one embodiment, the distal tips 132 of one or more fingers 120 may cooperate to define the second diameter (d2). In one embodiment, the second diameter (d2) may be smaller than the first diameter (d1). As shown in FIG. 2D , in one embodiment, the outer surfaces 128 of one or more fingers 120, e.g., first outer surface 128A and second outer surface 128B, may cooperate to define a tapered outer profile extending longitudinally from the distal tips 132 of the fingers 120.
[0035] As shown in FIGS. 4A-4B , the distal tip structure 104 can be configured to facilitate coupling of the catheter 90 to the stem 100 while maximizing fluid flow through the stem lumen 102. As shown in FIG. 4A , the catheter 90 can define a lumen 92 having a catheter lumen diameter (d3). The catheter lumen diameter (d3) can be equal to or greater than the second diameter (d2) defined by one or more fingers 120 of the tip structure 104. In one embodiment, the catheter lumen diameter (d3) can be equal to or less than the diameter (d1) of the distal opening 114. The tip structure 104 can be configured to fit within the catheter lumen 92. As shown in FIG. 4B, when the catheter 90 is urged proximally, the tapered outer profile of the tip structure 104 can elastically deform the catheter 90 from the catheter lumen diameter (d3) to the first diameter (d1) of the distal opening 114 and fit over the stem 100 to form a fluid-tight seal therebetween.
[0036] Advantageously, embodiments of the tip structure 104 can engage the inner surface of the catheter lumen 92 to facilitate coupling of the catheter 90 and stem 100 while mitigating any reduction in fluid flow compared to the diameter (d1) of the distal opening 114. For example, as shown in FIG. 3A , the diameter (d1) of the distal opening 114 can provide a first cross-sectional area and therefore a first fluid flow rate therethrough. The tip structure 104 can define a second diameter (d2) and fit within the catheter lumen diameter (d3). However, the relatively smaller diameter (d2) of the tip structure 104 can also provide a second, smaller cross-sectional area and a second, smaller fluid flow rate therethrough compared to the diameter (d1) of the distal opening 114. However, the tip structure 104 can also include a slot 130 that can provide an increase in cross-sectional area compared to the second diameter (d2) alone, mitigating any reduction in fluid flow between the distal opening 114 and the tip structure 104.
[0037] 3A, the tip structure 104 may include two or more fingers 120 defining two or more slots 130. Thus, a tip structure 104 including two or more slots 130 provides a further increase in cross-sectional area in addition to the second diameter (d2), further reducing the effect on fluid flow through the distal opening 114. In one embodiment, as shown in FIG. 3B, a decrease in the arc distance (θ) of one or more fingers 120, and thereby an increase in the arc distance (δ) of one or more slots 130, provides a further increase in cross-sectional area in addition to the second diameter (d2), further reducing the effect on fluid flow through the distal opening 114 at the first diameter (d1).
[0038] 5A-5D, a tip structure 104 including one or more slots 130 may further reduce the effect on fluid flow through the distal opening 114 by allowing fluid displaced by the fingers 120 to flow radially outward. As shown in FIGS. 5A-5B, the stem lumen 102 extending distally to the distal opening 114 at a first diameter (d1) provides a first cross-sectional area (FIG. 5B) and a first fluid flow 70 therethrough.
[0039] As shown in FIGS. 5C-5D, the tip structure 104 defines a lumen 108 having a discontinuous inner surface extending annularly; i.e., the tip structure includes one or more slots 130. Thus, even though the finger structures 120 extend radially inward to reduce the cross-sectional area over an arc distance (θ), the slots 130 allow fluid displaced by the fingers 120 to flow radially outward to provide the second fluid flow 72. In one embodiment, the second fluid flow 72 may extend radially outward to the inner diameter (d3) of the catheter lumen. In one embodiment, the inner diameter (d3) of the catheter lumen may be equal to or greater than the first diameter (d1) of the distal opening. As shown in FIG. 5D, in one embodiment, the second fluid flow 72 may flow radially outward to a diameter greater than the first diameter (d1). Thus, the reduction in cross-sectional area through the tip structure 104 from the first diameter (d1) to the second diameter (d2) is further offset by the radially outward flow 72 through the slots 130.
[0040] In one embodiment, the cross-sectional area of the second fluid flow 72 through the distal tip structure 104 (FIG. 5D) may be equal to or greater than the cross-sectional area of the first fluid flow 70 through the distal opening 114 (FIG. 5B). Thus, the distal tip structure 104 can have little or no effect on the fluid flow through the stem 100 while still facilitating coupling between the stem 100 and the catheter 90.
[0041] In one embodiment, the catheter lumen diameter (d3) may be larger than the first diameter (d1) of the distal opening 114. Thus, when the stem 100 is engaged with the catheter lumen 92, the distal tip structure 104 can extend into the catheter lumen 92 without elastically deforming the catheter 90. 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 coincides with the lumen inner diameter (d3), an axial force is required to elastically deform the catheter 90 to fit over the stem 100 and engage the stem with an interference fit. Advantageously, the tip structure 104 extending into the catheter lumen 92 can provide columnar support to the compliant catheter 90 when an axial force is applied. Thus, the distal tip structure 104 can reduce kinking of the catheter 90 and facilitate engagement with the catheter 90, while having little or no effect on the flow rate of fluid therethrough, as described herein.
[0042] In one embodiment, as shown in FIGS. 3C-3D , the tip structure 104 may include a single distally extending finger 120. The axis of the inner surface 126 of the finger 120 may be disposed radially inward relative to the edge of the distal opening 114. In one embodiment, the inner surface 126 of the finger 120 may be disposed at a radius (r2) from the central axis 80. In one embodiment, the two radii (r2) may be equal to the second diameter d2, i.e., 2(r2)=(d2). The finger 120 may extend into the catheter lumen 92 before an axial force is required to urge the catheter 90 over the stem 100. Advantageously, the finger 120 may guide the catheter 90 over the stem 100 and provide columnar support to the catheter 90 as it is urged over the stem 100, reducing kinking or collapse of the catheter lumen 92. Advantageously, a stem 100 including a tip structure 104 as described herein can be combined with a wider range of catheter sizes, increasing the versatility of the stem and reducing the product inventory that needs to be transported and stored by the user, reducing associated costs.
[0043] Some specific embodiments have been disclosed herein, and while those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and the broader aspects encompass those adaptations and / or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.
Claims
1. A stem for providing fluid communication between an access port and a catheter, comprising: an elongate body defining a body lumen, a distal opening of the body lumen having a first inner diameter; a tip structure extending distally from the distal opening, the tip structure comprising: a distal lumen having a second inner diameter smaller than the first inner diameter; a plurality of slots extending from the distal end of the tip structure to the distal opening of the body lumen; The stem, wherein the plurality of slots are configured to increase a cross-sectional area for fluid flow through the tip structure compared to a cross-sectional area corresponding to only the second inner diameter.
2. The stem of claim 1 , wherein the plurality of slots define a plurality of fingers.
3. The stem of claim 2 , wherein the fingers taper from a first wall thickness at a proximal end to a second wall thickness at a distal end that is thinner than the first wall thickness.
4. The stem of any one of claims 1 to 3, wherein the tip structure comprises an outer surface that tapers distally from a first, larger outer diameter to a second, smaller outer diameter.
5. The stem of any one of claims 1 to 4, wherein the elongate body comprises a circumferential ridge disposed along an outer surface of the elongate body.
6. The stem of any one of claims 1 to 5, wherein the stem is coupled to the access port in one of an interference fit, a press fit, or a snap fit engagement.
7. A stem according to any preceding claim, wherein the slot extends over an arc distance of less than 350°.
8. 4. The stem of claim 2 or 3, wherein one finger of the plurality of fingers extends radially over an arc distance of less than 350 degrees.
9. 1. A stem for providing fluid communication between a medical device and a catheter, comprising: a body defining a lumen extending between a proximal opening and a distal opening, the distal opening defining a first inner diameter; a tip structure disposed at a distal end of the body, the tip structure comprising one or more fingers extending radially inward and distally from the distal opening, an inner surface of a first finger of the one or more fingers extending along an axis of the lumen disposed radially inward from the distal opening; The stem defines a rigid structure formed from a rigid material.
10. The stem of claim 9 , wherein the first finger extends radially over an arc distance of less than 350°.
11. 11. The stem of claim 9 or 10, wherein the finger includes a proximal portion extending radially inward and distally from the distal opening, and a distal portion supported by the proximal portion and extending distally from the proximal portion.
12. The stem of claim 11 , wherein an inner surface of the distal portion extends parallel to the axis of the lumen and an outer surface of the distal portion extends at an angle to the axis of the lumen.
13. 13. The stem of claim 9, further comprising a second finger of the one or more fingers, the second finger being positioned at a different circumferential position around the axis of the lumen than the first finger, wherein an inner surface of the first finger and an inner surface of the second finger define a second inner diameter that is smaller than the first inner diameter.
14. 14. The stem of claim 13, wherein the outer surface of the first finger and the outer surface of the second finger define a tapered outer profile extending from a second smaller outer diameter to a first larger outer diameter.
15. 15. The stem of claim 13 or 14, wherein the first finger and the second finger define a slot extending longitudinally between the first finger and the second finger to the distal opening.
16. 16. The stem of claim 15, wherein the slot extends radially over an arc distance of less than 350 degrees.
Citation Information
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