Integrated catheter system having a near-patient access port and a visual display

Abstract

The integrated catheter system includes a needleless connector including a catheter adapter, a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port, an intermediate tube extending between the inlet of the catheter adapter and the first port of the needleless connector, an extension tube extending from the side port of the needleless connector, a first indicator provided on the first portion or the second portion of the needleless connector, and a second indicator provided on the first portion or the second portion of the needleless connector. The first indicator has a first color, and the second indicator includes at least one of a maximum rated pressure label, a flow capacity label, and a catheter length label.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 389,173, filed on July 14, 2022, entitled "Integrated Catheter System with a Proximal Patient Access Port and Visual Display", the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background of the Invention Field of the Invention This disclosure relates to an integrated catheter system having a proximal patient access port and visual display.

[0003] Description of the Related Art Catheters are commonly used in various infusion therapies. For example, catheters are used to infuse patients with fluids such as normal saline, various pharmaceuticals, total parenteral nutrition, and contrast agents under high pressure. Catheters are also used to draw blood from patients.

[0004] A common type of catheter is the over - the - needle peripheral intravenous ("IV") catheter ("PIVC"). The over - the - needle catheter may be placed over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle faces upward away from the patient's skin surface. The catheter and the introducer needle are generally inserted into the patient's vascular system from the skin at a shallow angle. To confirm that the introducer needle and / or the catheter are properly positioned within the blood vessel, the operator generally checks for a "flashback" of blood in the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the operator may temporarily occlude the flow of the vascular system and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.

[0005] Withdrawal of blood using a peripheral intravenous catheter (PIVC) can be difficult for several reasons, especially when the catheter dwell time exceeds one day. For example, if the catheter remains inserted in the patient for an extended period, the catheter or vein may be more susceptible to effects such as stenosis, collapse, kinking, occlusion by debris (e.g., fibrin or platelet clots), and adherence of the catheter tip to the vasculature. For this reason, while catheters are often used to collect blood samples during catheter placement, they are not often used to collect blood samples during the catheter dwell period.

[0006] Accordingly, blood aspiration devices have been developed for collecting blood samples through existing PIVCs. The blood aspiration device includes a flexible flow tube that is attached to the PIVC and advanced through the PIVC beyond the catheter tip into the blood vessel to collect a blood sample. After blood collection, the blood aspiration device is removed from the PIVC and discarded. An example of a blood aspiration device is shown and described in U.S. Patent No. 11,090,461, which is hereby incorporated by reference in its entirety. SUMMARY OF THE INVENTION

[0007] In one aspect or embodiment, the integrated catheter system includes a catheter and a catheter adapter having an inlet, the catheter adapter configured such that the catheter is inserted into a patient's vasculature, and a needleless connector having a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port, the second port having a valve member, the needleless connector including a first portion and a second portion. The system further includes an intermediate tube extending between the inlet of the catheter adapter and the first port of the needleless connector, an extension tube extending from the side port of the needleless connector, a first indicia provided on the first portion or the second portion of the needleless connector, the first indicia including a first color, and a second indicia provided on the first portion or the second portion of the needleless connector, the second indicia including at least one of a maximum rated pressure marking, a flow rate capacity marking, and a catheter length marking.

[0008] The first portion of the needleless connector may include the first port and the side port, and the second portion of the needleless connector may include the second port. The first indicia may be provided on the first portion of the needleless connector. The first color of the first indicia may indicate a high pressure injection capability. The second indicia may include a catheter length marking provided on the first portion of the needleless connector. The second indicia may include a maximum rated pressure marking and a flow rate capacity marking provided on the second portion of the needleless connector.

[0009] The first indicia may be provided on the second portion of the needleless connector, and the first color of the first indicia may indicate a high pressure injection capability.

[0010] The first indicator may include a second color different from the first color, with the first color of the first indicator provided on the second part of the needleless connector and the second color of the first indicator provided on the first part of the needleless connector. The first color of the first indicator may indicate high-pressure injection ability, and the second color of the second indicator may indicate blood suction ability. The second indicator may include a catheter length marker provided on the first part of the needleless connector and a flow rate ability marker provided on the second part of the needleless connector.

[0011] The first indicator may be provided on the first part of the needleless connector, and the first color of the first indicator may indicate blood suction ability. The first indicator may be provided on the second part of the needleless connector, and the first color of the first indicator may indicate blood suction ability.

[0012] The system may include a third indicator provided on the intermediate tube, and the third indicator may include at least one of a maximum rated pressure marker, a flow rate ability marker, and a catheter length marker. The body of the needleless connector may be opaque or transparent. The catheter may include a perforated tip.

[0013] The needleless connector includes a body that defines a longitudinal axis extending between a first port and a second port, and the side port may extend from the body at an angle of 30 to 150 degrees with respect to the longitudinal axis of the body. The side port is in fluid communication with the body of the needleless connector through an inlet, and the inlet may be offset from the longitudinal axis of the body of the needleless connector.

[0014] In one aspect or embodiment, the integrated catheter system includes a catheter adapter having a catheter and an inlet, the catheter being configured to be inserted into a patient's vasculature, the needleless connector including a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port, the second port including a valve member, the needleless connector including a first portion and a second portion, an intermediate tube extending between the inlet of the catheter adapter and the first port of the needleless connector, an extension tube extending from the side port of the needleless connector, and a first indicator provided on the first portion or the second portion of the needleless connector. The first indicator includes at least one of a first color.

[0015] The first indicator is a first color, and the first color may be provided on the first portion and the second portion of the needleless connector. The catheter may include a perforated tip.

Brief Description of the Drawings

[0016] The above and other features and advantages of the present disclosure, and the manner in which they are achieved, will become more apparent by reference to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings, and the present disclosure itself will be better understood.

[0017]

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[0018] Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein are illustrative of exemplary embodiments of the disclosure and are not to be construed as limiting the scope of the disclosure in any way.

DETAILED DESCRIPTION OF THE INVENTION

[0019] Detailed Description of the Invention Spatial or directional terms such as "left", "right", "inner", "outer", "upper", and "lower" are not considered limiting because the present invention can envision various alternative directions.

[0020] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and their derivatives shall relate to the present invention as oriented in the drawing figures. However, it should be understood that the present invention can envision various alternative variations, unless explicitly specified to the contrary. Also, it should 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.

[0021] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to include the starting and ending values, as well as any and all sub - ranges or sub - ratios subsumed therein. For example, a range or ratio of "1 to 10" is considered to include any and all sub - ranges or sub - ratios between (and including) the minimum value of 1 and the maximum value of 10, that is, all sub - ranges or sub - ratios that begin with a value of 1 or more and end with a value of 10 or less.

[0022] Terms such as "first", "second", etc. are not intended to refer to a particular order or sequence of events, but rather to different conditions, characteristics, or elements.

[0023] As used herein, "at least one" is synonymous with "one or more". For example, the expression "at least one of A, B, and C" means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of A alone, one or more of B alone, one or more of C alone, or one or more of A and one or more of B, or one or more of A and one or more of C, or one or more of B and one or more of C, or one or more of all of A, B, and C.

[0024] Referring to FIG. 1, the integrated catheter system 10 includes a catheter adapter 12 having a catheter 14 configured to be inserted into a patient's vasculature, a needleless connector 16, an intermediate tube 18, and an extension tube 20. The catheter adapter 12 includes an inlet 22. The needleless connector 16 includes a first port 24, a second port 26 positioned opposite the first port 24, and a side port 28 positioned between the first port 24 and the second port 26. The second port 26 includes a valve member 30. The intermediate tube 18 extends between the inlet 22 of the catheter adapter 12 and the first port 24 of the needleless connector 16. The extension tube 20 extends from the side port 28 of the needleless connector 16. The intermediate tube 18 is configured to provide flexibility when inserting and bandaging the catheter 14 and when manipulating the needleless connector 16 for cleaning, blood aspiration, and / or other procedures without disturbing the catheter insertion site. The proximity of the needleless connector 16 to the catheter adapter 12 is configured such that a blood aspiration device can project a sufficient distance beyond the end of the catheter 14. The extension tube 20 is configured to be utilized for introducing intravenous fluids, medications, and the like.

[0025] In one aspect or embodiment, the intermediate tube 18 has a length of 6-8 mm, although other suitable lengths may be utilized. A longer length of the intermediate tube 18 improves the ergonomics of insertion, the flexibility of access and fixation, and the ease of bandaging. However, increasing the length of the intermediate tube 18 shortens the distance that a blood aspiration device can project from the catheter 14 unless the blood aspiration device can accommodate a longer tube. In one aspect or embodiment, the intermediate tube 18 has a length shorter than the length of the extension tube 20. The intermediate tube 18 may have a length configured to allow a probe of the blood aspiration device to extend a predetermined length beyond the tip of the catheter 14.

[0026] Referring to FIG. 1, in one aspect or embodiment, the integrated catheter system 10 includes a needle hub assembly (not shown) and a medical component 36 such as a luer port connector. The needle hub assembly is assembled with the catheter adapter 12 by inserting a needle (not shown) into the lumen of the catheter 14. In one aspect or embodiment, the needle hub assembly includes a needle shield configured to secure the tip of the needle within the needle shield after use. The needle shield may be actuated passively. In one aspect or embodiment, the catheter adapter 12 includes one or more wings configured to engage the patient's skin surface as shown. In another aspect or embodiment, the catheter adapter 12 does not include wings.

[0027] When a blood aspiration device (not shown) is connected to the second port 26 of the needleless connector 16, the flow tube of the blood aspiration device can extend through the needleless connector 16, the intermediate tube 18, the inlet 22 of the catheter adapter 12, and the catheter 14. The blood aspiration device may be a PIVO (trademark) blood aspiration device commercially available from Becton Dickinson. In one aspect or embodiment, the blood aspiration device is the same as or similar to the blood aspiration device shown in U.S. Patent No. 11,090,461, which is hereby incorporated by reference in its entirety. In one aspect or embodiment, the blood aspiration device may be any device that advances a tube, probe, guidewire, instrument, and / or sensor within the fluid path of the integrated catheter system 10 or beyond the tip of the catheter 14.

[0028] The system 10 includes a needleless connector 16 having an optimized cleaning capacity feature, an optimized line aspiration device or probe guidance fluid path, a remote luer connection to reduce side operations, a catheter stabilization platform, and / or a direct probe access fluid path for advancing a probe within the catheter fluid path and beyond the catheter tip.

[0029] Referring to FIGS. 2 - 4, in one aspect or embodiment, the needleless connector 16 includes a body 62 that defines a flow path extending between a first port 24 and a second port 26. The side port 28 is offset from the center of the flow path. The offset of the side port 28 is configured such that fluid entering the body 62 through the side port 28 enters along the inner surface of the body 62 and creates a vortex within the body 62 to assist in cleaning the needleless connector 16. In one aspect or embodiment, the body 62 of the needleless connector 16 further includes an internal structure 66 configured to create a vortex when fluid enters the needleless connector 16 through the side port 28. In one aspect or embodiment, the offset and vortex - creating features are the same as or similar to the cleaning features shown and described in U.S. Patent Application Publication No. 2021 / 0220548, which is hereby incorporated by reference in its entirety.

[0030] Referring again to FIGS. 2 - 4, in one aspect or embodiment, the body 62 of the needleless connector 16 defines a longitudinal axis L extending between the first port 24 and the second port 26, and the side port 28 extends from the body 62 at an angle A of 30 - 150 degrees with respect to the longitudinal axis L of the body 62. In one aspect or embodiment, the side port 28 extends from the body 62 at an angle of 60 degrees with respect to the longitudinal axis L of the body 62. The side port 28 extends at an angle A towards the second port 26, although other suitable arrangements may be utilized. The body 62 of the needleless connector 16 includes a first portion 70 and a second portion 72 connected to the first portion 70. In some aspects or embodiments, the first portion 70 of the body 62 is fixedly secured to the second portion 72 of the body 62. In some aspects or embodiments, the body of the needleless connector is opaque or transparent.

[0031] Referring to FIGS. 1 - 15, in one aspect or embodiment, the system 10 includes a first indicia 80 provided on the first portion 70 or the second portion 72 of the needleless connector 16, and a second indicia 82 provided on the first portion 70 or the second portion 72 of the needleless connector 16. The first indicia 80 is of a first color, and the second indicia 82 includes at least one of a maximum rated pressure marking 84, a flow capacity marking 86, and a catheter length marking 88. The system 10 is configured to be used for high - pressure injection procedures, and the first and second indicia 80, 82 are configured to provide the capabilities of the system 10 to medical personnel, similar to an indication of which port to use for high - pressure injection procedures and / or aspiration or other procedures. In some aspects or embodiments, the first portion 70 of the needleless connector 16 includes a first port 24 and a side port 28, and the second portion 72 of the needleless connector 16 includes a second port 26, although the second portion 72 may also include a side port 28. In some aspects or embodiments, the catheter 14 includes a perforated tip 90.

[0032] Referring to FIG. 1, in one aspect or embodiment, the first indicia 80 is provided on the first portion 70 of the needleless connector 16. The first color of the first indicia 80 may indicate high - pressure injection capability. In one aspect or embodiment, the first color is purple, although other distinct or contrasting colors may be utilized. As shown in FIG. 1, the second indicia 82 includes a catheter length marking 88 provided on the first portion 70 of the needleless connector 16, and a maximum rated pressure marking 84 and a flow capacity marking 86 provided on the second portion 72 of the needleless connector 16.

[0033] Referring to FIG. 5, in one aspect or embodiment, the first indicator 80 includes a second color different from the first color. The first color of the first indicator 80 is provided on the second portion 72 of the needleless connector 16, and the second color of the first indicator 80 is provided on the first portion 70 of the needleless connector 16. The second color of the second indicator 82 indicates the blood suction ability. As shown in FIG. 5, the first color is purple and the second color is red, but other distinct or contrasting colors may be used. The second indicator 82 includes a catheter length indicator 88 provided on the first portion 70 of the needleless connector 16 and a flow capacity indicator 86 provided on the second portion 72 of the needleless connector 16. The system 10 includes a third indicator 92 provided on the intermediate tube 18, and the third indicator 92 may include at least one of the maximum rated pressure indicator 84, the flow capacity indicator 86, and the catheter length indicator 88. As shown in FIG. 5, the third indicator 92 is the maximum rated pressure indicator 84.

[0034] Referring to FIG. 6, in one aspect or embodiment, the first indicator 80 is provided on the first portion 70 of the needleless connector 16, and the second indicator 82 is the catheter length indicator 88 provided on the first portion 70 of the needleless connector 16.

[0035] Referring to FIG. 7, in one aspect or embodiment, the first indicator 80 is provided on the second portion 72 of the needleless connector 16, and the first color of the first indicator 80 indicates the high-pressure injection ability.

[0036] Referring to FIG. 8, in one aspect or embodiment, the first indicator 80 is provided on the first portion 70 of the needleless connector 16, and the second indicator 82 is the catheter length indicator 88 and the flow capacity indicator 86 provided on the first portion 70 of the needleless connector 16.

[0037] Referring to FIG. 9, in one aspect or embodiment, the first indicator 80 is provided on the first portion 70 of the needleless connector 16, and the second indicator 82 is the catheter length indicator 88 provided on the first portion 70 of the needleless connector 16 and the flow rate capacity indicator 86 provided on the second portion 72 of the needleless connector 16.

[0038] Referring to FIG. 10, in one aspect or embodiment, the first indicator 80 is provided on the first portion 70 of the needleless connector 16, and the second indicator 82 is the catheter length indicator 88 and the flow rate capacity indicator 86 provided on the second portion 72 of the needleless connector 16.

[0039] Referring to FIG. 11, in one aspect or embodiment, the first indicator 80 is provided on the second portion 72 of the needleless connector 16, and the second indicator 82 is the catheter length indicator 88 provided on the first portion 70 of the needleless connector 16 and the flow rate capacity indicator 86 provided on the second portion 72 of the needleless connector 16. In the aspects or embodiments shown in FIGS. 6 to 11, the first indicator 80 is a first color indicating high-pressure injection ability, such as purple.

[0040] Referring to FIG. 12, in one aspect or embodiment, the first indicator 80 is provided on the first portion 70 of the needleless connector 16, and the second indicator 82 is the catheter length indicator 88 provided on the first portion 70 of the needleless connector 16 and the flow rate capacity indicator 86 provided on the second portion 72 of the needleless connector 16.

[0041] Referring to FIG. 13, in one aspect or embodiment, the first indicator 80 is provided on the second portion 72 of the needleless connector 16, and the second indicator 82 is the catheter length indicator 88 provided on the first portion 70 of the needleless connector 16 and the flow rate capacity indicator 86 provided on the second portion 72 of the needleless connector 16.

[0042] Referring to FIG. 14, in one aspect or embodiment, the first indicator 80 is a second color provided on the first portion 70 of the needleless connector 16 and a first color provided on the second portion 72 of the needleless connector 16. As described above, the first color, such as purple, indicates high-pressure injection ability, and the second color, such as red, indicates blood suction ability or the ability to be used as an arterial catheter.

[0043] Referring to FIG. 15, in one aspect or embodiment, the first indicator 80 is a second color provided on the first portion 70 of the needleless connector 16, and the second indicator 82 is a catheter length marker 88 provided on the first portion 70 of the needleless connector 16 and a flow rate ability marker 86 provided on the second portion 72 of the needleless connector 16.

[0044] The present invention has been described in detail for the purpose of explanation based on what is currently considered to be the most practical and preferred embodiments, but such details are for that purpose only, and the present invention is not limited to the disclosed embodiments. On the contrary, it should be understood that it is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. An integrated catheter system comprising a catheter adapter having an inlet and a catheter configured to be inserted into a patient's vasculature, a needleless connector having a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port, wherein the second port comprises a valve member, and the needleless connector comprises a first portion and a second portion, an intermediate tube extending between the inlet of the catheter adapter and the first port of the needleless connector, an extension tube extending from the side port of the needleless connector, a first indicator provided on the first portion or the second portion of the needleless connector, the first indicator having a first color, and a second indicator provided on the first portion or the second portion of the needleless connector, the second indicator including at least one of a maximum rated pressure label, a flow capacity label, and a catheter length label, The system comprising.

2. The system of claim 1, wherein the first portion of the needleless connector includes the first port and the side port, and the second portion of the needleless connector includes the second port.

3. The system of claim 2, wherein the first indicator is provided on the first portion of the needleless connector.

4. The system of claim 3, wherein the first color of the first indicator indicates a high-pressure injection capacity.

5. The system of claim 3, wherein the second indicator includes a catheter length label provided on the first portion of the needleless connector.

6. The system of claim 5, wherein the second indicator includes the maximum rated pressure label and the flow capacity label provided on the second portion of the needleless connector.

7. The system of claim 2, wherein the first indicator is provided on the second portion of the needleless connector, and the first color of the first indicator indicates a high-pressure injection capacity.

8. The system according to claim 2, wherein the first indicator has a second color different from the first color, the first color of the first indicator is provided on the second portion of the needleless connector, and the second color of the first indicator is provided on the first portion of the needleless connector.

9. The system according to claim 8, wherein the first color of the first indicator indicates a high-pressure injection ability, and the second color of the second indicator indicates a blood suction ability.

10. The system according to claim 9, wherein the second indicator includes the catheter length marker provided on the first portion of the needleless connector and the flow capacity marker provided on the second portion of the needleless connector.

11. The system according to claim 2, wherein the first indicator is provided on the first portion of the needleless connector, and the first color of the first indicator indicates a blood suction ability.

12. The system according to claim 2, wherein the first indicator is provided on the second portion of the needleless connector, and the first color of the first indicator indicates a blood suction ability.

13. The system according to claim 1, further including a third indicator provided on the intermediate tube, the third indicator including at least one of a maximum rated pressure marker, a flow capacity marker, and a catheter length marker.

14. The system according to claim 1, wherein the body of the needleless connector is opaque or transparent.

15. The system according to claim 1, wherein the catheter has a perforated tip.

16. The system according to claim 1, wherein the needleless connector includes a body defining a longitudinal axis extending between the first port and the second port, and the side port extends from the body at an angle of 30 to 150 degrees with respect to the longitudinal axis of the body.

17. The system according to claim 1, wherein the side port is in fluid communication with the body of the needleless connector through the inlet, and the inlet is offset from the longitudinal axis of the body of the needleless connector.

18. An integrated catheter system includes a catheter adapter having a catheter and an inlet, the catheter being configured to be inserted into a patient's vascular system. A needleless connector comprising a first port, a second port positioned opposite the first port, and a side port positioned between the first port and the second port, wherein the second port comprises a valve member, and the needleless connector comprises a first portion and a second portion, needleless connector An intermediate tube extending between the inlet of the catheter adapter and the first port of the needleless connector An extension tube extending from the side port of the needleless connector, and A first indicator provided on the first portion or the second portion of the needleless connector, the first indicator including at least one of a first color, a maximum rated pressure label, a flow capacity label, and a catheter length label, first indicator A system comprising

19. The system according to claim 18, wherein the first indicator comprises a first color, and the first color is provided on the first portion and the second portion of the needleless connector

20. The system according to claim 18, wherein the catheter comprises a perforated tip

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