Integrated catheter system with near-patient access port - Patents.com

Abstract

The integrated catheter system includes a catheter adapter including a catheter and an inlet, where the catheter is configured to be inserted into a patient's vascular system; a 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, where the second port includes a valve member; an intermediate tube extending between the inlet of the catheter adapter and the first port of the needleless connector; and an extension tube extending from the side port of the needleless connector, where the needleless connector includes chlorhexidine.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 63 / 298,032, filed January 10, 2022, entitled "Integrated Catheter System with Near-Patient Access Port," the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present disclosure relates to an integrated catheter system having a near patient access port.

[0003] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient.

[0004] A common type of catheter is the over-the-needle peripheral intravenous ("IV") catheter ("PIVC"). Over-the-needle catheters may be mounted on an introducer needle that has a sharp distal tip. The catheter and 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 points up, away from the patient's skin surface. The catheter and introducer needle are generally inserted at a shallow angle from the skin into the patient's vasculature. To confirm that the introducer needle and / or catheter are properly placed within the blood vessel, the practitioner will generally confirm that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the practitioner may temporarily block flow through the vasculature to remove the needle, leaving the catheter in place for future blood withdrawals or fluid injections.

[0005] Withdrawing blood using a peripheral venous catheter can be difficult for several reasons, especially if the catheter is left in place for more than a day. For example, if a catheter remains in the patient for an extended period of time, the catheter or vein may become susceptible to stenosis, collapse, kinking, obstruction by debris (e.g., fibrin or platelet clumps), and adhesion of the catheter tip to the vasculature. For this reason, catheters are often used to obtain blood samples at the time of catheter placement, but are less often used to obtain blood samples during the catheter's indwelling period.

[0006] Accordingly, blood aspirators have been developed to collect blood samples through an existing PIVC. The blood aspirator includes a flexible flow tube that is attached to the PIVC and advanced through the PIVC and into the blood vessel beyond the catheter tip to collect the blood sample. After blood collection, the blood aspirator is detached from the PIVC and discarded. One example of a blood aspirator is shown and described in U.S. Patent No. 11,090,461, which is incorporated herein by reference in its entirety. Summary of the Invention

[0007] In one aspect or embodiment, the integrated catheter system includes a catheter adapter including a catheter and an inlet, where the catheter is configured to be inserted into a patient's vascular system, and a needleless connector including a first port, a second port disposed opposite the first port, and a side port disposed between the first port and the second port, the second port including a valve member, an intermediate tube extending between an inlet of the catheter adapter and the first port of the needleless connector, and an extension tube extending from the side port of the needleless connector, where the needleless connector contains chlorhexidine.

[0008] The chlorhexidine may be at least one of chlorhexidine diacetate and chlorhexidine gluconate. The needle-free connector may include a lubricant including chlorhexidine. The needle-free connector may include a coating including chlorhexidine. The needle-free connector may include an insert received within the needle-free connector, the insert may include chlorhexidine. The needle-free connector may include a flow diversion feature, the flow diversion feature may include an insert or a coating including chlorhexidine.

[0009] The needleless connector may include a body defining 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 relative to the longitudinal axis of the body. The side port may be in fluid communication with the body of the needleless connector via an inlet, and the inlet may be offset from the longitudinal axis of the body of the needleless connector. The flow diversion feature may include a lead-in configured to guide movement of the probe through the first port and / or the second port. The lead-in may include a pyramidal surface. The chlorhexidine may be configured to elute over a predetermined period of time.

[0010] According to one embodiment of the invention, a catheter system includes a catheter adapter including a catheter and an inlet, where the catheter is configured to be inserted into a patient's vascular system, and a needleless connector including a first port, a second port disposed opposite the first port, and a side port disposed between the first port and the second port, where the second port includes a valve member and the needleless connector includes chlorhexidine.

[0011] According to an embodiment of the present invention, the chlorhexidine includes at least one of chlorhexidine diacetate and chlorhexidine gluconate.

[0012] According to an embodiment of the present invention, the needleless connector includes a lubricant that includes chlorhexidine.

[0013] According to an embodiment of the present invention, the needleless connector includes a coating that includes chlorhexidine.

[0014] According to an embodiment of the present invention, a needleless connector includes an insert received within the needleless connector, the insert including chlorhexidine.

[0015] According to an embodiment of the present invention, a needleless connector comprises a flow diversion feature, the flow diversion feature comprising an insert or coating that includes chlorhexidine. [Brief description of the drawings]

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

[0017] [Figure 1] FIG. 1 is a perspective view of an integrated catheter system according to one aspect or embodiment of the present invention. [Diagram 2] FIG. 2 is a cross-sectional view of a needleless connector of the system of FIG. 1 according to one aspect or embodiment of the present invention. [Diagram 3] FIG. 3 is a cross-sectional view of a needleless connector of the system of FIG. 1 according to a further aspect or embodiment of the present application. [Figure 4] FIG. 4 is a cross-sectional view of a needleless connector of the system of FIG. 1 according to a further aspect or embodiment of the present application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein depict exemplary embodiments of the present disclosure, and such exemplifications are not to be construed as limiting the scope of the present disclosure in any manner.

[0019] Detailed Description of the Invention Spatial or directional terms such as "left," "right," "inside," "outside," "up," and "down" are not to be considered limiting as the present invention can contemplate various alternative orientations.

[0020] In the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof, refer to the invention as oriented in the drawing figures. It should be understood, however, that the invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention.

[0021] Unless otherwise indicated, all ranges or ratios disclosed herein are understood to encompass the starting and ending values, and any and all subranges or subratios subsumed therein. For example, a range or ratio of "1 to 10" should be considered to include every subrange or subratio between (and including) the minimum value of 1 and the maximum value of 10, i.e., every subrange or subratio beginning with a minimum value of 1 or greater and ending with a maximum value of 10 or less.

[0022] The terms "first," "second," and the like are not intended to refer to a particular order or chronology, but rather to different conditions, characteristics, or elements.

[0023] As used herein, "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, C" means any one of A, B, C, or any two or more of A, B, C in combination. For example, "at least one of A, B, and C" includes one or more of A alone, or one or more of B alone, or 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] 1 and 2, an integrated catheter system 10 includes a catheter adapter 12 having a catheter 14 configured to be inserted into a patient's vascular system, 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 disposed 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 in inserting and dressing the catheter 14 and manipulating the needleless connector 16 for irrigation, 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 to allow the blood suction device 32 to extend a sufficient distance beyond the end of the catheter 14. The extension tube 20 is configured to be utilized for the introduction of intravenous fluids, medications, and the like.

[0025] In one aspect or embodiment, the intermediate tube 18 has a length of 6-8 mm. In a further aspect or embodiment, the intermediate tube 18 has a length of up to 15 mm. Increasing the length of the intermediate tube 18 improves insertion ergonomics, flexibility of access and fixation, and ease of dressing. However, increasing the length of the intermediate tube 18 reduces the distance that the blood suction device 32 can protrude from the catheter 14 unless the blood suction device 32 allows for a longer tube. In one aspect or embodiment, the intermediate tube 18 has a length that is less than the length of the extension tube 20. The intermediate tube 18 may have a length configured to allow the probe of the blood suction device 32 to extend a predetermined length beyond the tip of the catheter 14.

[0026] With reference 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 passively actuated. 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 suction device (not shown) is connected to the second port 26 of the needleless connector 16, the flow tube of the blood suction device may extend through the needleless connector 16, through the intermediate tube 18, the inlet 22 of the catheter adapter 12, and through the catheter 14. The blood suction device may be a PIVO™ blood suction device available from Velano Vascular. In one aspect or embodiment, the blood suction device is the same as or similar to the blood suction device shown in U.S. Pat. No. 11,090,461, which is incorporated herein by reference in its entirety. In one aspect or embodiment, the blood suction device may be any device that advances tubes, probes, guidewires, instruments, and / or sensors into the fluid path of the integrated catheter system 10 or beyond the tip of the catheter 14. In one aspect or embodiment, the needleless connector 16 is similar to and operates similarly to the connectors shown and described in U.S. Patent Application Publication No. 2019 / 0160275, which is incorporated herein by reference in its entirety.

[0028] 1 and 2, in one aspect or embodiment, an integrated catheter system 10 is optimized for compatibility with blood aspiration devices and to reduce the risk of injection associated with catheter access. The system 10 includes a needleless connector 16 that includes optimized cleansability features, integrated antimicrobial features, an optimized blood aspiration device or probe guide fluid path, a remote luer connection to reduce lateral manipulation, a catheter stabilization platform, and / or a direct probe access fluid path that allows the probe to be advanced into the catheter fluid path and beyond the tip of the catheter.

[0029] Referring to FIG. 2, in one aspect or embodiment, the needleless connector 16 includes chlorhexidine. In one aspect or embodiment, the chlorhexidine includes at least one of chlorhexidine diacetate and chlorhexidine gluconate. The chlorhexidine diacetate and chlorhexidine gluconate are configured to be provided at an optimal concentration and elution profile for a safe and effective antimicrobial activity profile. As shown in FIG. 2, the needleless connector 16 includes a lubricant 38 containing chlorhexidine. The lubricant 38 may be positioned on the valve member 30 of the needleless valve 16, such as on a slit in the valve member 30, although other suitable locations may be utilized. The lubricant 38 may be a silicone lubricant. In a further aspect or embodiment, the needleless connector 16 includes a coating or insert 40 received within the needleless connector 16, the coating and / or insert 40 containing chlorhexidine. The insert 40 may be formed with a shape configured to provide a compression fit of the insert 40 within the needleless connector 16 to prevent the insert 40 from moving or dislodging once inserted within the needleless connector 16. The material of the insert 40 may be hygroscopic so that the insert 40 swells when it receives a fluid, thereby enhancing the compression fit of the insert 40 within the connector 16. The material of the insert 40 may be reinforced with internal structures. The insert 40 may be formed by casting, thermoforming, or extrusion. Chlorhexidine may be included in the water-absorbent UV-curable adhesive coating, the insert, and / or the lubricant. Other antimicrobial agents may be included in the coating or in the molded part with silver or other additives.

[0030] The needleless connector 16 includes flow diverting features 42 configured to improve the cleanability of the needleless connector 16, such as by creating turbulence, swirls, and / or vortices within the connector 16. In one aspect or embodiment, the chlorhexidine is configured to elute over a predetermined period of time, such as the dwell time of the catheter 14. The chlorhexidine may be configured to elute upon exposure to fluid within the needleless connector 16. The chlorhexidine is antimicrobial and configured to kill bacteria, and may be introduced into or present in the fluid pathway of the system 10.

[0031] Suitable antimicrobial lubricants are described in U.S. Patent Nos. 9,956,379; 9,675,793; 8,426,348; and 8,754,020; and 8,691,881, each of which is incorporated herein by reference in its entirety. Suitable antimicrobial insert or coating techniques, including antimicrobial agent concentration, matrix volume, surface area, and elution profile, are described in U.S. Patent Nos. 10,792,399; 10,792,398; and 10,589,063, each of which is incorporated herein by reference in its entirety. Examples of suitable formulations and methods that can be used to apply the formulation onto needleless connectors are described in U.S. Patent Application Publication No. 2014 / 0200523, entitled "Systems and Methods for Applying Novel Antimicrobial Coating Materials to Medical Devices," which is incorporated herein by reference in its entirety.

[0032] In certain aspects and embodiments, the antimicrobial coating may be formed of a matrix that includes one or more antimicrobial agents. For example, the matrix may be a polymer or other suitable material that is cured (e.g., via UV curing) or otherwise bonded to the surface of the connector. In such coatings, the antimicrobial agents will be eluted in a controlled manner from the matrix coating. Examples of suitable matrices and methods of applying the matrix that may be employed to form an antimicrobial coating on the connector are U.S. Patent No. 8,512,294, entitled "Vascular Access Device Antimicrobial Materials and Solutions," U.S. Patent Application No. 12 / 397,760, entitled "Antimicrobial Compositions," U.S. Application No. 12 / 476,997, entitled "Antimicrobial Compositions," U.S. Application No. 12 / 490,235, entitled "Systems and Methods for Applying Antimicrobial Coatings to Medical Devices," and U.S. Application No. 12 / 831,880, entitled "Antimicrobial Coatings for Skin Invasive Devices," each of which is incorporated herein by reference in its entirety.

[0033] With reference to FIG. 3, in one aspect or embodiment, flow diversion feature 42 includes an insert or coating containing chlorhexidine.

[0034] 4, in one aspect or embodiment, the flow diversion feature 42 includes a lead-in portion 44 configured to guide movement of the probe through the first port 24 and / or the second port 26 of the needleless connector 16. The lead-in portion 44 includes a cone surface 46, although other suitable structures or features may be utilized.

[0035] 2-4, 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 between 30 and 150 degrees relative 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 relative to the longitudinal axis L of the body 62. The side port 28 extends at the angle A toward the second port 26, although other suitable arrangements may be utilized. The side port 28 is in fluid communication with the body 62 of the needleless connector 16 via an inlet 64, which is offset from the longitudinal axis L of the body 62 of the needleless connector 16. The angle A and offset of the side port 28 are configured to improve the cleanability of the needleless connector 16 by creating turbulence, swirl, and / or vortex within the connector 16.

[0036] In one aspect or embodiment, at least a portion of the needleless connector 16 is transparent. The connector components of the integrated catheter 10 may be transparent, opaque, and / or colored. In one aspect or embodiment, the needleless connector 16 includes an anti-reflux valve.

[0037] In one aspect or embodiment, the medical component 36 at the end of the extension tube 20 may be a single or dual port connector and may include a variety of connectors including a needleless connector or a needle access connector such as a PRN. The extension tube 20 may be left or right oriented. In one aspect or embodiment, in addition to a vent plug, the medical component 36 may be a removable or non-removable needleless connector or a needle access connector such as a PRN that is attached to a female luer connection provided on the extension tube 20. In one aspect or embodiment, dual female luer ports may be coupled or otherwise attached to the extension tube 20 in place of a single luer connector.

[0038] In one aspect or embodiment, the needleless connector 16 is configured to be cleaned by a single cleaning process via the side port 28.

[0039] System 10 incorporates cleanability and antimicrobial features to synergistically improve catheter performance by combining two important means of reducing infection risk, reducing the risk of device contamination and patient infection: reducing the number of bacteria in the system (improved cleanability) and reducing the viability of any remaining bacteria (antimicrobials). These benefits may be combined with other integral catheter benefits to provide integral catheter probe access with a reduced overall risk of catheter complications.

[0040] While the invention has been described in detail for the purpose of illustration based on what are presently considered to be the most practical and preferred embodiments, it is to be understood that such detail is for the purposes of illustration only, and that the invention is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the 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. The integrated catheter system a catheter adapter comprising a catheter and an inlet, the catheter 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, the second port comprising a valve member; an intermediate tube extending between the inlet of the catheter adapter and the first port of the needleless connector; and an extension tube extending from the side port of the needleless connector; A catheter system, wherein the needleless connector comprises chlorhexidine.

2. The system of claim 1 , wherein the chlorhexidine comprises at least one of chlorhexidine diacetate and chlorhexidine gluconate.

3. The system of claim 1 or claim 2, wherein the needleless connector includes a lubricant comprising the chlorhexidine.

4. The system of any of claims 1 to 3, wherein the needleless connector includes a coating that includes the chlorhexidine.

5. The system of any of claims 1 to 4, wherein the needleless connector comprises an insert received within the needleless connector, the insert containing the chlorhexidine.

6. The system of any of claims 1 to 5, wherein the needleless connector comprises a flow diversion feature, the flow diversion feature comprising an insert or coating that contains the chlorhexidine.

7. 7. The system of claim 1, wherein the needleless connector comprises 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 relative to the longitudinal axis of the body.

8. The system of any one of claims 1 to 7, wherein the side port is in fluid communication with the body of the needleless connector via an inlet, the inlet being offset from the longitudinal axis of the body of the needleless connector.

9. The system of claim 6 , wherein the flow diversion feature comprises a lead-in configured to guide movement of a probe through the first port and / or the second port.

10. The system of claim 9 , wherein the guide comprises a cone surface.

11. The system of any of claims 1 to 10, wherein the chlorhexidine is configured to elute over a predetermined period of time.

12. The catheter system a catheter adapter comprising a catheter and an inlet, the catheter configured to be inserted into a patient's vascular system; and 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, the second port comprising a valve member, the needleless connector containing chlorhexidine; A catheter system comprising:

13. 13. The system of claim 12, wherein the chlorhexidine comprises at least one of chlorhexidine diacetate and chlorhexidine gluconate.

14. The system of any of claims 12-13, wherein the needleless connector includes a lubricant comprising the chlorhexidine.

15. The system of any of claims 12-14, wherein the needleless connector includes a coating that includes the chlorhexidine.

16. The system of any of claims 12-15, wherein the needleless connector comprises an insert received within the needleless connector, the insert containing the chlorhexidine.

17. The system of any of claims 12-16, wherein the needleless connector comprises a flow diversion feature, the flow diversion feature comprising an insert or coating containing the chlorhexidine.

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