Blood collection device having a variable diameter fluid flow conduit

Abstract

A blood suction device for withdrawing blood through an intravenous catheter assembly including a catheter, the blood suction device comprising a housing, a fluid conduit received within the housing and having a proximal end portion and a distal end portion, the fluid conduit including a first conduit portion at the proximal end portion of the fluid conduit, the first conduit portion having a proximal end portion, a distal end portion, and a first diameter, and a second conduit portion at the distal end portion of the fluid conduit, the second conduit portion having a proximal end portion, a distal end portion, and a second diameter different from the first diameter, the fluid conduit being configured to be advanced from a proximal position where the second conduit portion does not extend beyond the distal end portion of the catheter to a distal position where the second conduit portion extends beyond the distal end portion of the catheter.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 389,183, filed July 14, 2022, entitled "Blood Collection Device with Variable Diameter Fluid Flow Conduit", the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background of the Invention Field of the Invention Provided herein are devices and systems for use in vascular access, and in particular, devices and systems for use in blood aspiration through an indwelling peripheral catheter.

[0003] Description of the Related Art Vascular access devices (VADs) may access a patient's peripheral vasculature. VADs may be indwelling for short periods (days), intermediate periods (weeks), or long periods (months to years). VADs may be used for infusion therapy and / or blood withdrawal.

[0004] A common type of VAD is an over - the - needle peripheral intravenous catheter (PIVC). Currently, there may be several limitations to using a PIVC for infusion or blood aspiration. The PIVC or vein may narrow, ulcerate, or become blocked over time, leading to PIVC failure. Also, the small lumen size required for the devices used to withdraw blood through a PIVC can cause low flow rates and blockages, making the process somewhat inefficient. Thus, there is a need in the art for devices and systems that allow for higher flow rates of blood when withdrawing blood through a PIVC.

Summary of the Invention

[0005] Provided herein is a blood suction device for withdrawing blood through an intravenous catheter assembly including a catheter, the blood suction device including a housing, a fluid conduit received within the housing and having a proximal end portion and a distal end portion, the fluid conduit including a first conduit portion at the proximal end portion of the fluid conduit, the first conduit portion having a proximal end portion, a distal end portion, and a first diameter, and a second conduit portion at the distal end portion of the fluid conduit, the second conduit portion having a proximal end portion, a distal end portion, and a second diameter different from the first diameter, the fluid conduit being configured to be advanced from a proximal position where the second conduit portion does not extend beyond the distal end of the catheter to a distal position where the second conduit portion extends beyond the distal end of the catheter.

[0006] Also provided herein is a catheter system including a catheter assembly including a catheter adapter having a distal end portion, a proximal end portion, and a lumen extending between the distal end portion and the proximal end portion, and a catheter fixed to the catheter adapter and extending distally from the catheter adapter, the catheter having a distal end portion and a proximal end portion, an intravenous catheter assembly, and a blood suction device for withdrawing blood through the intravenous catheter assembly, the blood suction device including a housing, a fluid conduit received within the housing and having a proximal end portion and a distal end portion, the fluid conduit including a first conduit portion at the proximal end portion of the fluid conduit, the first conduit portion having a proximal end portion, a distal end portion, and a first diameter, and a second conduit portion at the distal end portion of the fluid conduit, the second conduit portion having a proximal end portion, a distal end portion, and a second diameter different from the first diameter, the fluid conduit being configured to advance from a proximal position where the second conduit portion does not extend beyond the distal end of the catheter to a distal position where the second conduit portion extends beyond the distal end of the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0007]

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Best Mode for Carrying Out the Invention

[0008] Description of the Invention The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to one of ordinary skill in the art. All such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of the present invention.

[0009] In the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof are to relate to the present invention as oriented in the drawing figures. However, it is to be understood that the present invention can assume various alternative variations unless explicitly specified to the contrary. Also, it is to be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0010] It is to be understood that the numerical ranges provided herein are intended to include all values and subranges subsumed therein. For example, a range of "1 to 10" is intended to include all subranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., subranges having a minimum value of 1 or more and a maximum value of 10 or less.

[0011] Provided herein are devices and systems for blood aspiration via an indwelling catheter such as a peripheral intravenous catheter (PIVC). Although specific blood aspiration devices are shown in the accompanying figures and described below, one of ordinary skill in the art will understand that the variable diameter fluid conduits described herein may be useful in any number of different blood aspiration devices where a smaller diameter conduit is useful and / or necessary.

[0012] Turning to FIG. 1, shown is a system having a catheter assembly 10 and a blood suction device 100. The catheter assembly 10 may include a catheter adapter 12, which may include a distal end portion 14 and a proximal end portion 16. In some embodiments, the catheter adapter 12 may include an additional port 18. In some embodiments, the port 18 may be disposed between the distal end portion 14 and the proximal end portion 16. In some embodiments, the port 18 may be disposed at the proximal end portion 16. In some embodiments, the first catheter adapter 12 may include a first lumen 20 extending through the distal end portion 14 and the proximal end portion 16.

[0013] In some non-limiting embodiments or aspects, the catheter assembly 10 may include a catheter 22 extending from the distal end portion 14. In some embodiments, the first catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter. The catheter 22 may be formed of any suitable material and may be of any useful length, as known to those skilled in the art. In some non-limiting embodiments or aspects, the catheter assembly 10 may include a first fluid conduit 24 extending from the port 18. The first fluid conduit 24 may be formed of any suitable material known to those skilled in the art. In some non-limiting embodiments or aspects, a connector 30 may be coupled to the first fluid conduit 24. The connector 30 may be a T-connector (e.g., one side port disposed at an angle of 90 degrees with respect to the longitudinal axis of the connector 30), a Y-connector (e.g., one side port disposed at an angle of 25 degrees, 60 degrees, or 75 degrees with respect to the longitudinal axis of the connector 30), or any other type of connector known in the art, and may include therein a second lumen having any number of branches suitable for the type of connector.

[0014] In some non-limiting embodiments or aspects, the catheter assembly 10 may include an extension set that includes a second fluid conduit 34. In a non-limiting embodiment, the connector 30 may include a port to which an extension set (e.g., the second fluid conduit 34) may be connected. Extension sets 34 are known to those of ordinary skill in the art and are commercially available, for example, under the trade names MAXPLUS, MAXZERO, NEUTRACLEAR, Q-SYTE, and SMARTSITE from Becton, Dickinson and Company. In some non-limiting embodiments or aspects, the second fluid conduit 34 may include a luer connection 36 at its end. In some non-limiting embodiments or aspects, the extension set may include a clamp 40 to enable occlusion of the second fluid conduit 34. The clamp 40 and the second fluid conduit 34 may be formed of any suitable material known to those of ordinary skill in the art.

[0015] The catheter assembly 10 may include a needleless access connector 32. Needleless access connectors 32 are known to those of ordinary skill in the art and are commercially available, for example, under the product names MAXPLUS, MAXZERO, Q-SYTE, and SMARTSITE from Becton, Dickinson and Company.

[0016] Continuing to refer to FIG. 1, also shown is a blood suction device 100 having a distal end portion 102 and a proximal end portion 104. Exemplary blood suction devices are described, for example, in U.S. Patent Application Publication No. 2020 / 0316346 and U.S. Patent No. 10,300,247, the contents of which are hereby incorporated by reference in their entirety. The blood suction device 100 may include, at its distal end portion 102, one or more structures for reversibly connecting to the catheter assembly 10 via a needleless access connector 32 as shown, for example, in FIG. 1. The blood suction device 100 includes a fluid flow conduit 110 that is at least partially received within the housing of the device 100. In a non-limiting embodiment, the conduit 110 is movably received within the blood suction device 100 such that when the device 100 is coupled to the catheter assembly, the conduit 110 is capable of advancing through the catheter adapter 12 and the catheter 22 and into the patient's vasculature. As will be described in more detail below, the conduit 110 may include a first conduit portion 112 and a second conduit portion 114. The first conduit portion 112 and the second conduit portion 114 may be formed of any suitable material including polymeric materials, metals, alloys, and combinations thereof. The blood suction device 100 may include, at the proximal end portion of the first conduit portion 112, a luer lock adapter (LLA), such as an LLA 46 as shown in FIG. 1, a luer connector 116 for reversibly connecting to one or more devices for performing blood suction. The LLA 46 may receive a syringe and / or a vacuum container for withdrawing blood through the conduit 110.

[0017] Turning to FIGS. 2A-8, as described above, the conduit 110 may include a first conduit portion 112 and a second conduit portion 114. In a non-limiting embodiment, the first conduit portion 112 has a larger diameter than the second conduit portion 114, increasing the connector and at the same time enabling passage through the variable internal shape of the IV catheter as explained in Equation 1 below:

[0018]

Number

[0019] Here, Q is the flow rate, P is the pressure, r is the radius, η is the fluid viscosity, and l is the length of the tube. By increasing the radius of the tube, for example, by using a first conduit portion 112 with a larger diameter, the flow rate can be increased.

[0020] The term "conduit portion" is used herein, and those skilled in the art will understand, with particular reference to the accompanying figures, that each conduit portion may be a separate fluid conduit formed of the same material or separate materials. One or both of the first conduit portion 112 and the second conduit portion 114 may be formed of a material including polyurethane, polyimide, or other suitable materials known to those skilled in the art.

[0021] With respect to FIGS. 2A and 2B, shown is a non-limiting embodiment in which the conduit 110 includes a first conduit portion 112 having at least a first diameter and a second conduit portion 114 having a second diameter, the second diameter being smaller than the first diameter. The first conduit portion 112 may overlap the second conduit portion 114 by a first distance 120. The first fluid conduit 112 may include a taper 122 to a tip region having a smaller diameter (shown as being of the same extent as the region of the overlap 120 in FIG. 2A), where in a non-limiting embodiment, the second conduit portion 114 may be received in a fluid-impermeable manner. At one or more positions along the overlap region 120, the first conduit portion 112 and the second conduit portion 114 may be joined together, for example, by heat shrinkage, by using one or more adhesives, welding, and / or other known processes for joining two structures in a fluid-tight manner. FIG. 2B shows two different embodiments, one having a taper and a tip region and one not having a taper and a tip region.

[0022] With respect to FIGS. 2C and 2D, shown is a non-limiting embodiment of a conduit 110 for use with a blood aspiration device 100, where the second conduit portion 114 itself includes a number of portions having different inner diameters. An arrangement is illustrated where the second conduit portion 114 includes a larger diameter portion 114a, a smaller diameter portion 114b, and a transition portion 114c, but those skilled in the art will understand that, for the purpose of increasing the flow rate and increasing the diameter of the conduit 110 as quickly as possible (as described above), any number of steps with respect to the diameter of the conduit may be included at any suitable location along the second conduit portion 114 and / or the first conduit portion 112, with or without a transition portion that varies the rate of increase of the diameter. Further, at any junction between portions of the conduit having different diameters (e.g., between 114a and 114b), any of the transition portions or junctions described herein may be used.

[0023] Turning to FIGS. 3A and 3B, in the conduit embodiments disclosed herein, the distal end of the second conduit portion 114 may include one or more openings 130, for example, in its sidewall. As shown in FIG. 3A, in a non-limiting embodiment, one or more openings 130 are formed directly in the second conduit portion. In a non-limiting embodiment, as shown, for example, in FIG. 3B, one or more openings 130 may be included in a third conduit portion 132 disposed at the distal end of the second conduit portion 114. The third conduit portion 132 may be formed of nitinol or other materials described herein or known to those skilled in the art and may be coupled to the second conduit portion 114 by known means, including those described herein. In a non-limiting embodiment, the second conduit portion 114 and / or the third conduit portion 132 may be formed of stainless steel or nitinol and may be coupled to the second conduit portion 114 and / or the first conduit portion 112 by known means. In a non-limiting embodiment, the third conduit portion 132 includes a non-traumatic tip (e.g., rounded) to reduce the likelihood of damage to the vasculature.

[0024] Turning to FIGS. 4A-6, in non-limiting embodiments, the first conduit portion 112 and the second conduit portion 114 may be joined to each other by use of a joining device. Such a joining device may take the form of a sleeve, such as an expandable sleeve 140 (FIG. 4), a wedge 150 (FIG. 5), and / or a bushing 160 (FIG. 6), for example, and may provide a fluid-tight connection between the first conduit portion 112 and the second conduit portion 114. Each of the sleeve 140, the wedge 150, and the bushing 160 may be formed of any suitable material, such as metal, alloy (e.g., nitinol), plastic, etc., and each joining device may be joined to the first conduit portion 112 and / or the second conduit portion 114 by known methods, such as those disclosed herein. Although specific arrangements of the joining devices are shown in FIGS. 4A-6, those skilled in the art will understand that any joining device may be disposed on the inside of the first conduit portion 112 and / or the second conduit portion 114 or around the outer surface thereof.

[0025] With respect to FIGS. 4A-4B, as described above, the sleeve 140 may be formed of any suitable material (nitinol in non-limiting embodiments), may be of any suitable length, and may be of any arrangement in terms of the length and distance between struts, the angle of the helix, and similar parameters known to those skilled in the art. The sleeve 140 may be disposed inside the first conduit portion 112 and / or the second conduit portion 114 (FIG. 4A) and / or around the outside of the first conduit portion 112 and / or the second conduit portion 114 (FIG. 4B). In non-limiting embodiments, the sleeve 140 is joined to the first conduit portion 112 and / or the second conduit portion 114 by use of an adhesive.

[0026] With respect to FIG. 5, the wedge 150 as described above may be formed of any suitable material and may include one or more flare portions 152, 154. The flare portions 152, 154 may be conical in shape. The flare portions 152, 154 may be at different angles for joining a first fluid conduit 112 having a larger diameter to a second fluid conduit 114 having a smaller diameter. For example, the flare portion 152 may be configured such that it may be received within the smaller inner diameter of the second conduit portion 114, while the flare portion 154 may be configured such that it may be received within the larger inner diameter of the first conduit portion 112.

[0027] With respect to FIG. 6, the bushing 160 as described above may be formed of any suitable material and may include a proximal end portion 164 and a distal end portion 162. The proximal end portion 164 may be received within the larger diameter of the first conduit portion 112 (e.g., such that the diameter of the joint does not become larger than the diameter of the first conduit portion 112), while the distal end portion 162 may surround the smaller diameter of the second conduit portion 114. The bushing 160 may have a variable inner diameter, e.g., a larger diameter at the distal end portion 162, such that the second conduit portion 114 and the bushing 160 provide a substantially uniform inner diameter. Although not shown, the bushing 160 may also be disposed around the outside of the first conduit portion 112 and within the second conduit portion 114. In non-limiting embodiments, the bushing 160 may be coupled to the first and second conduit portions 112, 114 by known methods described herein and / or may be formed as one piece with one or more of the conduit portions, e.g., by overmolding. In non-limiting embodiments, the bushing 160 includes a flange(s) 166, for example, to provide a stop for the first fluid conduit 112. In non-limiting embodiments (not shown), the bushing 160 is an additional conduit portion that fills a gap when the inner diameter of the first conduit portion 112 is larger than the outer diameter of the second conduit portion 114.

[0028] Turning to FIG. 7, shown is a non-limiting embodiment in which a first conduit portion 112 and a second conduit portion 114 are joined by overmolding. The first fluid conduit 112 may have a tip region, as described above. Overmolding processes for joining two or more components are known to those skilled in the art.

[0029] Turning to FIG. 8, shown is a non-limiting embodiment in which a first conduit portion 112 and a second conduit portion 114 are joined via one or more interlock elements. For example, the first conduit portion 112 may include one or more openings 170 at or near its distal end, and the second conduit portion 114 may include one or more protrusions 172 at or near its proximal end, and the conduit portions are joined together such that one or more protrusions 172 may be received within one or more openings 170. The opening(s) 170 and protrusion(s) 172 may be of any suitable number, size, and shape.

[0030] The present disclosure has been described in detail for purposes of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects thereof, but such details are for that purpose only, and the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. It is to be understood, for example, that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A blood suction device for withdrawing blood through an intravenous catheter assembly, the blood suction device comprising: a housing, a fluid conduit displaceably received within the housing and having a proximal end portion and a distal end portion, the fluid conduit comprising: a first conduit portion at the proximal end portion of the fluid conduit, the first conduit portion having a proximal end portion, a distal end portion, and a first diameter, and a second conduit portion at the distal end portion of the fluid conduit, the second conduit portion having a proximal end portion, a distal end portion, and a second diameter different from the first diameter, the fluid conduit; comprising, the fluid conduit being configured to be advanced from a first proximal position where the second conduit portion does not extend beyond the distal end portion of the catheter of the intravenous catheter assembly to a second distal position where the second conduit portion extends beyond the distal end portion of the catheter of the intravenous catheter assembly.

2. The blood suction device according to claim 1, wherein the first diameter is larger than the second diameter.

3. The blood suction device according to claim 1, wherein the distal end portion of the first conduit portion overlaps the proximal end portion of the second conduit portion.

4. The blood suction device according to claim 3, wherein the first conduit portion includes a proximal-to-distal taper to a smaller diameter at its distal end portion.

5. The blood suction device according to claim 3, wherein the first conduit portion is joined to the second conduit portion by an adhesive, welding, and / or overmolding.

6. The blood suction device according to claim 1, wherein the first conduit portion is joined to the second conduit portion using a stent.

7. The blood suction device according to claim 6, wherein the stent is formed of nitinol.

8. The blood suction device according to claim 6, wherein the stent is joined to the first conduit portion and / or the second conduit portion by an adhesive and / or welding.

9. The blood suction device according to claim 6, wherein the stent is disposed around the outer surfaces of the first conduit portion and the second conduit portion.

10. The blood suction device according to claim 6, wherein the stent is received within the first conduit portion and the second conduit portion.

11. The blood suction device according to claim 1, wherein the first conduit portion is joined to the second conduit portion by a double-sided wedge.

12. The blood suction device according to claim 11, wherein the double-sided wedge includes a first conical end received within the first conduit portion and a second conical end received within the second conduit portion.

13. The blood suction device according to claim 11, wherein the double-sided wedge is joined to the first conduit portion and / or the second conduit portion by an adhesive and / or welding.

14. The blood suction device according to claim 1, wherein the first conduit portion is joined to the second conduit portion using a bushing having a proximal end and a distal end.

15. The blood suction device according to claim 14, wherein the proximal end of the bushing is received within the first conduit portion and the distal end of the bushing is disposed around the outer surface of the second conduit portion.

16. The blood suction device according to claim 14, wherein the bushing further includes one or more flanges, and the distal end of the first conduit portion abuts against the one or more flanges.

17. The blood suction device according to claim 14, wherein at least a portion of the inner diameter of the bushing is the same as the second diameter.

18. The blood suction device according to claim 14, wherein the bushing is joined to the first conduit portion and / or the second conduit portion by an adhesive and / or welding.

19. The first conduit portion includes one or more openings in its side wall at or near its distal end, and The blood suction device according to claim 1, wherein the second conduit portion includes one or more protrusions extending from its side wall at or near its proximal end.

20. The blood suction device according to claim 19, wherein the one or more protrusions are received within the one or more openings to lock the first conduit portion to the second conduit portion.

21. The blood suction device according to claim 1, wherein the second conduit portion includes one or more openings in its side wall at or near its distal end.

22. The blood suction device according to claim 1, further comprising a third conduit portion disposed at the distal end of the second conduit portion, the third conduit portion including one or more openings in its side wall.

23. The blood suction device according to claim 22, wherein the third conduit portion has a rounded distal end portion.

24. A catheter system comprising a catheter assembly comprising a catheter adapter having a distal end portion, a proximal end portion, and a lumen extending between the distal end portion and the proximal end portion, and a catheter fixed to the catheter adapter and extending distally from the catheter adapter, the catheter having a distal end portion and a proximal end portion, a catheter assembly, and a blood suction device for withdrawing blood through an intravenous catheter assembly, the blood suction device comprising a housing, a fluid conduit displaceably received within the housing and having a proximal end portion and a distal end portion, the fluid conduit comprising a first conduit portion at the proximal end portion of the fluid conduit, the first conduit portion having a proximal end portion, a distal end portion, and a first diameter, and a second conduit portion at the distal end portion of the fluid conduit, the second conduit portion having a proximal end portion, a distal end portion, and a second diameter different from the first diameter, a fluid conduit, and the fluid conduit is configured to be advanced from a first proximal position where the second conduit portion does not extend beyond the distal end portion of the catheter of the intravenous catheter assembly to a second distal position where the second conduit portion extends beyond the distal end portion of the catheter of the intravenous catheter assembly. A catheter system.

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