Non-integrated catheter and extension set system and method for blood culture sample collection - Patents.com

Abstract

A catheter extension set is disclosed that includes a body defining a flow path for conducting a biological fluid, a connection port defined in the body, where an extension tube is in fluid communication with the connection port, an exhaust access port in fluid communication with the extension tube, where the exhaust access port is spaced apart from the connection port, a non-integral catheter removably connectable to the body for conducting the biological fluid into the body, and a distal access port defined in the body, where the distal access port is configured to be in fluid communication with a removable sample collection container. An initial volume of biological fluid conducted through the body is conducted through the connection port to the extension tube and to the exhaust access port.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 316,596, entitled "Non-Integrated Catheter and Extension Set System and Method for Blood Culture Sample Collection," filed March 4, 2022, the entire disclosure of which is incorporated herein by reference.

[0002] SUMMARY The present disclosure relates to catheter extension devices, and more particularly to catheter extension devices that include a drainage access port for redirecting an initial volume of biological fluid withdrawn from a patient. [Background technology]

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

[0004] A common type of catheter device is what is called an "over-the-needle" catheter. As the name suggests, an over-the-needle catheter may be mounted over an introducer needle with a sharp distal tip. The catheter assembly may include a catheter adapter, a catheter extending distally from the catheter adapter, and an introducer needle extending through the catheter. 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 with the needle bevel pointing away from the patient's skin. The catheter and introducer needle are typically inserted into the patient's vascular system at a shallow angle from the skin.

[0005] To verify proper placement of the introducer needle and / or catheter within the vasculature, the clinician will typically confirm the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block flow through the vasculature and remove the introducer needle, leaving the catheter in place for future blood draws or infusions.

[0006] Current catheter systems used to draw blood from patients present inherent challenges to the quality of blood culture samples drawn from patients. In particular, many current catheter systems draw an initial volume of blood for blood culture samples that often contains microorganisms and other contaminants from the patient's skin pricked by the catheter needle. The microorganisms and contaminants can render the blood culture sample unusable and can lead to erroneous test results when the blood culture sample is analyzed. Summary of the Invention [Problem to be solved by the invention]

[0007] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments, but rather this background is provided only to illustrate one example technology area in which some of the embodiments described herein may be practiced. [Means for solving the problem]

[0008] According to one embodiment of the invention, a catheter extension set includes a body defining a flow path for conducting biological fluid, a connection port defined in the body, where an extension tube is in fluid communication with the connection port, a distal access port defined in the body, and an exhaust access port in fluid communication with the extension tube, where the exhaust access port is spaced from the connection port, and an initial volume of biological fluid conducted through the body is conducted via the extension tube to the exhaust access port.

[0009] In certain configurations, the catheter extension set also includes a non-integral catheter removably connectable to the body. The catheter extension set can also include a stabilization platform operably connected to the body for stabilizing the catheter extension set on a desired surface. In other configurations, the catheter extension set can also include a Luer adapter, and the exhaust access port is integrated with the Luer adapter. The device can also include an exhaust plug integrated with at least one of the Luer adapter and the exhaust access port. In certain configurations, the catheter extension set can include an exhaust plug operably connected to the exhaust access port at an end of the extension tube opposite the connection port.

[0010] In certain configurations, the catheter extension set may also include a clamping member disposed on a portion of the extension tube, where in a clamped position, the clamping member is configured to occlude at least a portion of the extension tube. The catheter extension set may also include a luer lock access device fluidly connected to the distal access port. The exhaust access port may also include a dual port luer adapter operably connected to an end of the extension tube opposite the connection port.

[0011] According to another embodiment of the present invention, a catheter extension set includes a body defining a flow path for conducting a biological fluid, a connection port defined in the body, where an extension tube is in fluid communication with the connection port, and an exhaust access port in fluid communication with the extension tube, where the exhaust access port is spaced from the connection port. The catheter extension set also includes a non-integral catheter removably connectable to the body for conducting the biological fluid into the body, and a distal access port defined in the body, where the distal access port is configured to be in fluid communication with a removable sample collection container. An initial volume of biological fluid conducted through the body is conducted through the connection port to the extension tube and to the exhaust access port.

[0012] In certain configurations, an initial blood volume is directed to the exhaust access port, after which a portion of the biological fluid is directed to a removable sample collection container. The catheter extension set can also include a removable sample collection container in fluid communication with the distal access port.

[0013] In certain configurations, the removable sample collection container is a blood culture sample collection tube. The catheter extension set can also include a stabilizing platform operably connected to the body for stabilizing the catheter extension set on a desired surface. Optionally, the catheter extension set can include a luer adapter, and the exhaust access port is integral with the luer adapter. The catheter extension set can also include an exhaust plug integral with at least one of the luer adapter and the exhaust access port. In other configurations, the catheter extension set also includes a clamping member disposed on a portion of the extension tube, and in the clamped position, the clamping member is configured to occlude at least a portion of the extension tube. The catheter extension set can include a luer lock access device fluidly connected to the distal access port. Optionally, the exhaust access port can include a dual port luer adapter operably connected to an end of the extension tube opposite the connection port.

[0014] According to another embodiment of the present invention, a method of collecting a biological fluid sample includes providing a catheter extension set having a body defining a channel for directing the biological fluid therein, a connection port defined in the body, where an extension tube is in fluid communication with the connection port, an exhaust access port in fluid communication with the extension tube, where the exhaust access port is spaced apart from the connection port, and a distal access port defined in the body, where the distal access port is configured to be in fluid communication with a removable sample collection container. The method also includes receiving an initial amount of the biological fluid into the catheter extension set and directing the initial amount of the biological fluid through the connection port and into the extension tube in fluid communication with the connection port. The method also includes evacuating air from the initial amount of the biological fluid through the exhaust access port operably connected to the extension tube and occluding the extension tube.

[0015] In certain configurations, the method further includes the step of collecting a subsequent volume of the biological fluid from the catheter extension set into a blood culture sample collection tube. [Brief description of the drawings]

[0016] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of a catheter extension set with an attached blood collection device according to one non-limiting embodiment or aspect of the present disclosure. [Diagram 2] FIG. 2 is a perspective view of the catheter extension set of FIG. 1 with the blood collection device removed. [Diagram 3] FIG. 3 is a perspective view of a catheter extension set with an extension tube for a blood collection device according to one non-limiting embodiment or aspect of the present disclosure. [Figure 4] FIG. 4 is a perspective view of a catheter extension set with a dual port luer lock adapter according to one non-limiting embodiment or aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0018] Unless expressly indicated otherwise, the use of numerical values ​​in the various ranges specified in this application includes approximations within the stated ranges. In this manner, slight variations above and below the stated ranges can be used to achieve substantially the same results as the values ​​within the ranges. Also, unless otherwise indicated, the disclosure of these ranges is intended as a continuous range including all values ​​between the minimum and maximum values. For the definitions provided herein, the definitions refer to word forms, cognates, and grammatical variations of those words or phrases.

[0019] The figures accompanying this application are representative in nature and should not be construed to imply any particular scale or orientation unless specifically indicated. For purposes of explanation hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "vertical" and their derivatives refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative variations and sequences of steps unless expressly specified to the contrary. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0020] Referring to FIG. 1, according to one non-limiting embodiment or aspect of the present disclosure, a catheter extension device 200 may be used to extract a blood culture sample from a patient using a catheter 202 extending from the catheter extension device 200. The catheter extension device 200 may be used with any straight, ported, or non-integral catheter, with or without blood control technology. In this embodiment, the catheter extension device 200 is non-integral with the catheter 202. "Non-integral" may be understood to mean that the catheter 202 is not initially connected to the catheter extension device 200, but instead is operatively connected to the catheter extension device 200 after the catheter 202 is placed in the patient. The catheter 202 is operatively connected to the catheter extension device 200 via a catheter adapter 204 provided on the catheter 202. The catheter extension device 200 may include a body 201 defining a fluid channel for directing a biological fluid thereto. In one embodiment, the biological fluid is blood. To stabilize the catheter extension device 200 on the patient's skin, the body 201 may be provided with a stabilizing platform 203.

[0021] The catheter extension device 200 can receive the blood sample from the catheter 202 and direct the blood sample to a luer lock adapter device 206 into which a blood culture sample collection tube 213 is inserted, as is conventionally known. The catheter extension device 200 can define a patient distal access port 208 opposite the catheter adapter 204. The distal access port 208 can be configured to mate with a luer lock adapter device 206 configured to receive a blood culture sample collection tube 213. The blood culture sample collection tube 213 can be removably inserted into the luer lock adapter device 206 to receive a blood sample collected through the catheter 202. After a sufficient blood sample has been collected from the catheter 202, the blood culture sample collection tube 213 can be removed from the luer lock adapter device 206 in a conventional manner. Multiple blood culture samples can be collected by removing and connecting multiple blood culture sample collection tubes 213 with the luer lock adapter device 206. After all desired blood culture and other blood samples have been collected using the catheter extension device 200, the luer lock adapter device 206 and blood culture sample collection tube 213 can be removed from the distal access port 208 and the remaining blood volume can be flushed out of the distal access port 208 or the drainage access port 210 (described below) to remove the blood volume from the catheter 202.

[0022] In one non-limiting embodiment or aspect, the catheter extension device 200 can also include a connection port 211 defined between the catheter adapter 204 and the distal access port 208 in the body 201 of the catheter extension device 200. The extension tube 212 is operably connected to the connection port 211 to receive an initial blood sample from the catheter 202. In one embodiment, when an initial volume of blood from the patient enters the catheter 202 and the catheter extension device 200, the initial volume of blood is directed through the connection port 211 to fill the extension tube 212 up to the exhaust function of the exhaust access port 210. The exhaust access port 210 can include a luer adapter 215 provided at an end of the extension tube 212 opposite the connection port 211. The luer adapter 215 can be used to operably and fluidly connect the exhaust access port 210 to the extension tube 212.

[0023] In one embodiment, the drain access port 210 may also include a drain plug 216 retained therein. After the initial volume of blood is separated through the drain plug 216, the blood volume is directed through the distal access port 208 to the blood culture sample collection tube 213. In one embodiment, instead of the drain plug 216, an isolated blood collection device may be in fluid communication with a luer adapter 215 at the end of the extension tube 212 to receive and retain the initial volume of drained blood through the drain access port 210. In one aspect, the initial volume of blood may be drained into the extension tube 212 to ensure that a high quality blood culture is collected from the catheter 202 into the blood culture sample collection tube 213. The initial volume of blood received from the catheter 202 may be at high risk of introducing undesirable microorganisms into the blood culture sample due to bacteria introduced by contact with the patient's skin and dermal layer during the catheter insertion process. In one embodiment of the present disclosure, the initial volume of blood drained from the catheter extension device 200 may be greater than 0.15 mL. In one embodiment, the initial volume of blood may occupy only the drain plug 216, or only the drain plug 216 and extension tube 212 between the drain plug 216 and the clamping position of the clamping member 218 (described below).

[0024] In one embodiment, a flashback of blood may be observed within the catheter extension device 200 as an initial volume of blood is directed into the extension tube 212. During this time, air is removed from within the drainage access port 210, including the extension tube 212 and the drainage plug 216.

[0025] In one embodiment, a clamping member 218 can be provided on the extension tube 212 to occlude the extension tube 212 and isolate the initial blood volume within the extension tube 212 and / or the drain plug 216 to prevent the initial blood volume from flowing back into the catheter extension device 200. After the clamping member 218 occludes the extension tube 212, the drain plug 216 can be removed from the luer adapter 215 in order to discard the initial blood volume.

[0026] Current methods of extracting blood culture samples from patients include using non-catheter venipuncture devices with manual or passive blood diversion to separate the initial volume of blood drawn during venipuncture of the patient. In contrast, the catheter extension device 200 of the present invention, by adding an exhaust access port 210, in combination with following certain methods and procedural steps, can obtain high quality samples for blood culture testing while significantly minimizing the risk of sample contamination and costly false positive blood culture results. Utilizing this catheter extension device 200 and procedural method to obtain blood culture samples eliminates or significantly reduces the need for additional patient discomfort, hospital costs, and procedural steps required to obtain blood culture samples. By providing the catheter extension device 200 with an exhaust access port 210, a physician or nurse can eliminate the need for the additional step and risk of contamination of a waste sample of blood prior to obtaining a blood culture sample.

[0027] 1 and 2, a method of using a catheter extension device 200 to obtain a blood culture sample from a patient is described according to one non-limiting embodiment or aspect of the present disclosure. According to this method, first, a catheter 202 is inserted into the patient. The catheter 202 is then operatively connected to the catheter extension device 200 using a catheter adapter 204. When the catheter 202 is connected to the catheter extension device 200, a flashback of blood, including an initial volume of blood, is directed through the connection port 211 into the extension tube 212. The initial volume of blood may be directed to a drain plug 216 held in a luer adapter 215. The initial volume of blood is directed through the extension tube 212, and the drain plug 216 may optionally be used to drain air from the extension tube 212 via the drain access port 210. A clamp member 218 may then be applied to the extension tube 212 to occlude the extension tube 212 and prevent the initial volume of blood from flowing back into the catheter extension device 200. After the initial blood volume is directed through the outlet access port 210, the catheter 202 can direct the blood culture sample through the catheter extension device 200 and out the distal access port 208 to a blood culture sample collection tube 213. After a desired volume of the blood culture sample has been received from the distal access port 208, the blood culture sample collection tube 213 can be removed from the catheter extension device 200 for analysis of the blood culture sample.

[0028] In one embodiment, during the catheter placement process and after connection of the catheter extension device 200, an initial volume of blood flows into the drain access port 210 at the proximal end of the fluid path of the catheter extension device 200 and the extension tube 212 due to venous blood pressure. When the catheter 202 is connected to the catheter extension device 200 using the adapter 204, the initial volume of blood enters the catheter extension device 200. The initial volume of blood enters the inner diameter of the needle and then passes through an insta-flash notch on the needle into the space between the catheter 202 and the needle. The initial volume of blood then passes through the catheter 202, the catheter adapter 204, and is stopped by the blood control valve (if used). After the needle is removed from the patient's vein, the catheter extension device 200 is connected to the catheter 202, and the initial volume of blood flows through the catheter extension device 200 toward the drain plug 216 on the drain access port 210.

[0029] In one embodiment, when the initial blood volume contacts the drain plug 216, drainage and blood flow into the catheter system is stopped. The drain plug 216 may be a membrane, paper, porous material, porous film, or mechanical feature that allows air to pass while preventing fluid from passing therethrough. The portion of the blood volume that travels through the drain plug 216, the catheter adapter 204, and the extension tube 212 is the initial blood volume that enters the catheter extension device 200 during insertion, and therefore, is at high risk of introducing skin flora into the blood culture sample. The catheter extension device 200 uses a configuration that isolates this initial blood volume, greatly reducing the chance of contaminating the blood culture sample with microorganisms introduced through the skin during the catheter insertion process.

[0030] 3, in another non-limiting embodiment or aspect of the present disclosure, the luer lock adapter device 206 can be operatively connected to the distal access port 208 via an extension tube 220. The extension tube 220 can be integral with the luer lock adapter device 206 or can be removably connected to the luer lock adapter device 206. The extension tube 220 allows for increased flexibility during blood collection and allows the blood culture sample collection tube 213 to be placed in an upright position during blood collection. The overall fluid path of the extension tube 220 can be optimized to reduce hemolysis during the blood culture sample collection step and / or subsequent evacuated tube or syringe-based blood samples collected after the blood culture sample is collected. In one embodiment, the overall fluid path of the extension tube 220 can include a hemoshield fluid path. In one embodiment, an example of a blood shield fluid pathway is disclosed in U.S. Patent Application Publication No. 2021 / 0186394, published on June 24, 2021, the disclosure of which is incorporated by reference in its entirety.

[0031] 4, in another non-limiting embodiment or aspect of the present disclosure, the extension tube 212 may also include a dual port proximal luer adapter 222. One port 224 of the dual port proximal luer adapter 222 may include an end cap 226 for connection to an isolated blood collection device configured to receive an initial volume of blood directed through the extension tube 212, and the other port 228 of the dual port proximal luer adapter 222 may hold the drain plug 216. In some embodiments, the proximal luer adapter provided at the tip of the extension tube 212 may be single, dual, or triple port. The isolated blood collection device may include a luer lock access device, a luer lock access device with an extension tube, or a luer lock access device integrated with an extension tube to create a sterile blood collection convenience kit that receives an isolated volume of blood from the extension tube 212. In one embodiment, the extension tube 212 may include a luer lock access device pre-attached near the connection port 211 defined in the body 201 of the catheter extension device 200. The dual port proximal luer adapter 222 has an internal volume of the drained port and drain plug 216 that is larger than the required isolated blood volume, allowing one port to be used in a drained configuration and the other port 228 to be reserved for blood culture sampling. In this type of use, the drain plug 216 becomes wet when a blood culture sample is being taken from the other port 228, preventing air from entering the system.

[0032] In other embodiments or aspects of the present disclosure, the clamping member 218 may be a pinch clamp, a slide clamp, a roller clamp, or a stopcock clamp, among other types of clamps. The initial blood volume may be isolated within the extension tube 212 using a one-way drain / fluid valve proximal to the drain access port 210. The initial blood volume may also be isolated within the extension tube 212 using a drainage material that can wet the catheter extension device 200 under vacuum during the sample collection step and prevent air from entering. The luer lock adapter device 206 or features of the extension tube 220 may occlude the extension tube 212.

[0033] In one embodiment or aspect, the internal volume of the drain plug 216 may be 0.15 mL or more to ensure that a sufficient amount of the initial blood sample is diverted and separated. Alternatively, the internal volume of the drain plug 216 and the luer adapter 215 connected to the drain access port 210 may be 0.15 mL or more. In another embodiment, the internal volume of the extension tube 212 proximal to the clamping position may be 0.15-2.0 mL or more. In another embodiment, the internal volume of the extension tube 212 proximal to the clamping member 218 near the drain access port 210 may be 0.15-2.0 mL or more. In some embodiments, the initial blood volume isolated should be 0.1-5.0 mL or more.

[0034] The present disclosure provides many unique advantages over current blood culture sample collection devices. The number of needle sticks required by the patient is reduced, improving the patient experience. The catheter extension device 200 incorporates automatic and passive diversion features to capture the initial blood flow. The risk of contamination of the blood culture sample is reduced because all instruments used are sterile packaged. The catheter extension device 200 also provides passive blood diversion, including passive or manual (clamping) diverted blood isolation. Diverting the initial blood volume eliminates the need for a blood waste sample and also eliminates the need for a sterile blood waste sample. The use of the catheter extension device 200 also improves the physician or nurse workflow in that it reduces steps in the blood culture sample collection process and reduces the number of connections, thereby reducing contamination changes during blood culture sample collection. Connection to the luer lock adapter device 206 allows for evacuated tube blood collection immediately after blood culture sample collection from the patient. The catheter extension device 200 also provides an optimized fluid path to reduce hemolysis in subsequent blood collection samples.

[0035] Although the invention has been described in light of the above detailed description, those skilled in the art will appreciate that modifications can be made which remain within the spirit of the invention.

Claims

1. 1. A catheter extension set comprising: a body defining a flow path for conducting a biological fluid; a connection port defined within the body, the connection port being in fluid communication with an extension tube; a distal access port defined in the body; an exhaust access port in fluid communication with the extension tube, the exhaust access port being spaced apart from the connection port; Equipped with A catheter extension set, wherein an initial volume of biological fluid directed through the body is directed via the extension tube to the evacuation access port.

2. The catheter extension set of claim 1 , further comprising a non-integral catheter removably connectable to the body.

3. The catheter extension set of claim 1 , further comprising a stabilizing platform operably connected to the body for stabilizing the catheter extension set on a desired surface.

4. Further comprising a lure adapter; The catheter extension set of claim 1 , wherein the exhaust access port is integral with the luer adapter.

5. 5. The catheter extension set of claim 4, further comprising a drainage plug integral with at least one of the luer adapter and the drainage access port.

6. 10. The catheter extension set of claim 1, further comprising a drainage plug operably connected to the drainage access port at an end of the extension tube opposite the connection port.

7. a clamp member disposed on a portion of the extension tube; The catheter extension set of claim 1 , wherein the clamping member is configured to occlude at least a portion of the extension tube in a clamped position.

8. The catheter extension set of claim 1 , further comprising a luer lock access device in fluid communication with the distal access port.

9. 10. The catheter extension set of claim 1, wherein the exhaust access port comprises a dual port luer adapter operably connected to an end of the extension tube opposite the connection port.

10. 1. A catheter extension set comprising: a body defining a flow path for conducting a biological fluid; a connection port defined within the body, the connection port being in fluid communication with an extension tube; an exhaust access port in fluid communication with the extension tube, the exhaust access port being spaced apart from the connection port; a non-integral catheter removably connectable to the body for directing biological fluid into the body; a distal access port defined in the body, the distal access port configured to be in fluid communication with a removable sample collection container; Equipped with A catheter extension set, wherein an initial volume of biological fluid directed through the body is directed through the connection port, into the extension tube, and into the evacuation access port.

11. The catheter extension set of claim 10, wherein after the initial blood volume is directed to the exhaust access port, a portion of the biological fluid is directed to the removable sample collection container.

12. The catheter extension set of claim 10, further comprising the removable sample collection container in fluid communication with the distal access port.

13. 13. The catheter extension set of claim 12, wherein the removable sample collection container is a blood culture sample collection tube.

14. The catheter extension set of claim 10, further comprising a stabilizing platform operably connected to the body for stabilizing the catheter extension set on a desired surface.

15. Further comprising a lure adapter; The catheter extension set of claim 10, wherein the exhaust access port is integral with the luer adapter.

16. 16. The catheter extension set of claim 15, further comprising a drainage plug integral with at least one of the luer adapter and the drainage access port.

17. a clamp member disposed on a portion of the extension tube; The catheter extension set of claim 10 , wherein the clamping member is configured to occlude at least a portion of the extension tube in a clamped position.

18. The catheter extension set of claim 10, further comprising a luer lock access device in fluid communication with the distal access port.

19. The catheter extension set of claim 10, wherein the exhaust access port comprises a dual port luer adapter operably connected to an end of the extension tube opposite the connection port.

20. 1. A method for obtaining a biological fluid sample, comprising: providing a catheter extension set comprising: a body defining a flow path for conducting a biological fluid; a connection port defined within the body, the connection port being in fluid communication with an extension tube; an exhaust access port in fluid communication with the extension tube, the exhaust access port being spaced apart from the connection port; and a distal access port defined within the body, the distal access port configured to be in fluid communication with a removable sample collection container; receiving an initial amount of the biological fluid into the catheter extension set; directing an initial amount of the biological fluid through the connection port and into the extension tube in fluid communication with the connection port; evacuating air from the initial volume of biological fluid through the evacuation access port operably connected to the extension tube; and c) occluding the extension tube.

21. 21. The method of claim 20, further comprising the step of collecting a subsequent amount of biological fluid from the catheter extension set into a blood culture sample collection tube.

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