Integrated catheter system and method for collection of blood culture samples - Patents.com

Abstract

Disclosed is an integrated catheter having a body defining a channel for directing a biological fluid through it, a connection port defined in the body, where an extension tube is fluidly coupled to the connection port, a vent access port in fluid communication with the extension tube, where the vent access port is spaced from the connection port, an integrated catheter operatively coupled to the body for directing 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 biological fluid volume directed through the body is routed through the connection port into the extension tube and directed into the vent access port.

Description

[Technical field]

[0001] The present disclosure is directed to integrated catheter devices, particularly catheter devices that include a vent access port for redirecting an initial volume of biological fluid withdrawn from a patient.

[0002] This application claims priority to U.S. Provisional Application No. 63 / 316,617, entitled "Integrated Catheter System and Method for Collection of Blood Culture Samples," filed March 4, 2022, the entire disclosure of which is incorporated by reference in its entirety. [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 may also be 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 bevel of the needle facing away from the patient's skin. The catheter and introducer needle are typically inserted at a shallow angle through the skin into the patient's vascular system.

[0005] To verify proper placement of the introducer needle and / or catheter within the blood vessel, the clinician will typically confirm that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily occlude flow within the vasculature and withdraw the introducer needle, leaving the catheter in place for subsequent blood collection or transfusion.

[0006] Current catheter systems used to draw blood from patients have inherent problems with the quality of the blood culture samples drawn from the patient. In particular, many current catheter systems collect an initial volume of blood for the blood culture sample that may often contain microorganisms and other contaminants from the patient's skin that is pierced by the catheter needle. The microorganisms and contaminants may render the blood culture sample unusable or provide erroneous test results when the blood culture sample is analyzed.

[0007] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in certain environments such as those described above. Rather, this background is provided only to illustrate one example technology area in which some of the embodiments described herein may be practiced. Summary of the Invention

[0008] According to one embodiment of the present invention, a catheter having an integral extension set includes a body defining a channel therethrough for directing a biological fluid, a connection port defined in the body with an extension tube fluidly coupled to the connection port, a distal access port defined in the body, and a vent access port in fluid communication with the extension tube, the vent access port spaced from the connection port, and an initial volume of biological fluid directed through the body is directed via the extension tube to the vent access port.

[0009] In certain configurations, the integrated catheter also includes an integrated extension set operably connected to the body. The integrated catheter may also include a stabilization platform operably connected to the body to stabilize the catheter on a desired surface. In other configurations, the integrated catheter extension set may also include a Luer adapter, and the vent access port is integrated with the Luer adapter. The device may also include a vent plug integrated with at least one of the Luer adapter and the vent access port. In certain configurations, the integrated catheter extension set may include a vent plug operably connected to the vent access port at the end of the extension tube opposite the connection port.

[0010] In certain configurations, the integrated catheter may also include a clamping member disposed about 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 integrated catheter may also include a Luer lock access device fluidly connected to the distal access port. The vent access port may also include a dual port Luer adapter operatively connected to an end of the extension tube opposite the connection port.

[0011] According to another embodiment of the present invention, a catheter having an integral extension set includes a body defining a channel therethrough for directing biological fluid, a connection port to which an extension tube is fluidly coupled, a distal access port defined in the body, and a vent access port in fluid communication with the extension tube, the vent access port being spaced apart from the connection port. The integrated catheter also includes an integral extension set operably connected to the body for directing biological fluid to the body, and a distal access port defined in the body, the distal access port being configured to be in fluid communication with a removable sample collection container. An initial biological fluid volume directed through the body is routed through the connection port into the extension tube and directed into the vent access port.

[0012] In certain configurations, a portion of the biological fluid is routed to a removable sample collection container after the initial blood volume is routed to the vent access port. The integrated catheter may 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 integrated catheter may also include a stabilization platform operably connected to the body to stabilize the catheter on a desired surface. Optionally, the integrated catheter extension set may also include a Luer adapter, and the vent access port is integrated with the Luer adapter. The catheter extension set may also include a vent plug integrated with at least one of the Luer adapter and the vent access port. In other configurations, the integrated catheter may also include a clamp member disposed around a portion of the extension tube, and in a clamped position, the clamp 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. Optionally, the vent access port may also include a dual port Luer adapter operatively 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 an integrated catheter having an integrated extension set having a body defining a channel for passing the biological fluid therethrough, a connection port defined in the body where an extension tube is fluidly coupled to the connection port, a vent access port in fluid communication with the extension tube, the vent access port spaced from the connection port, and a distal access port defined in the body, the distal access port configured to be in fluid communication with a removable sample collection container. The method also includes receiving an initial volume of the biological fluid into the integrated catheter and directing the initial volume of the biological fluid through the connection port and into an extension tube fluidly connected to the connection port. The method also includes evacuating air from the initial volume of the biological fluid through the vent access port operatively connected to the extension tube and occluding the extension tube.

[0015] In certain configurations, the method further includes 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] Exemplary embodiments will be described and explained with additional specificity and detail through the use of 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 description 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 process sequences unless expressly specified to the contrary. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered as limiting.

[0020] Referring to FIG. 1, according to one non-limiting embodiment or aspect of the present disclosure, an integrated catheter device 200 may be used to extract a blood culture sample from a patient using a catheter 202 extending from the integrated catheter device 200. In this embodiment, the catheter extension device 200 is integrated with the catheter 202. "Integrated" may be understood to mean that the catheter 202 is operatively connected to the integrated catheter device 200 or is integrally formed with the integrated catheter device 200. The catheter 202 may be operatively connected to the integrated catheter device 200 via an adapter 204 provided on the catheter 202. The catheter extension device 200 may include a body 201 defining a fluid channel for passing a biological fluid therethrough. In one embodiment, the biological fluid may be blood. A stabilizing platform 203 may be provided on the body 201 to allow the integrated catheter device 200 to be stabilized on the patient's skin.

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

[0022] In one non-limiting embodiment or aspect, the integrated catheter device 200 may also include a connection port 211 defined between the adapter 204 and the distal access port 208 of the body 201. An extension tube 212 may be operatively 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, the initial volume of blood may be directed through the connection port 211 to fill the extension tube 212 up to the vent feature of the vent access port 210. The vent access port 210 may include a luer adapter 215 provided at an end of the extension tube 212 opposite the connection port 211. The luer adapter 215 may be used to operatively and fluidly connect the vent access port 210 to the extension tube 212.

[0023] In one embodiment, the vent access port 210 may also include a vent plug 216 retained therein. After the initial volume of blood is separated through the vent plug 216, the volume of blood may be routed through the distal access port 208 into the blood culture sample collection tube 213. In one embodiment, instead of the vent plug 216, the isolated blood collection device may be fluidly connected to a luer adapter 215 at the end of the extension tube 212 to receive and hold the initial volume of blood vented through the vent access port 210. In one aspect, the initial volume of blood may be vented through the extension tube 212 to ensure that a high quality blood culture is drawn 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 skin layer during the catheter insertion process. In one embodiment of the present disclosure, the initial volume of blood expelled from the integrated catheter device 200 may be greater than 0.15 mL. In one embodiment, the initial volume of blood may occupy only the vent plug 216, or may occupy the vent plug 216 and the extension tube 212 between the vent plug 216 and the clamping position of the clamping member 218 (described below).

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

[0025] In one embodiment, a clamp member 218 may 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 vent plug 216 to prevent the initial blood volume from flowing back into the catheter extension device 200. After the clamp member 218 occludes the extension tube 212, the vent plug 216 may be removed from the luer adapter 215 for disposal of the initial blood volume.

[0026] Current methods for extracting blood culture samples from patients include using non-catheter venipuncture devices with manual or passive blood diversion capabilities to separate the initial blood volume captured during venipuncture of the patient. In contrast, the integrated catheter device 200 of the present invention adds a vent access port 210, which, in combination with the following specific methods and procedural steps, allows for the collection of high quality samples for blood culture testing with significantly minimized risk of sample contamination and risk of costly false positive blood culture test results. Utilizing the integrated catheter device 200 of the present invention and procedural methods for collecting blood culture samples, eliminates or significantly reduces the need for additional patient pain, hospital costs, and procedural steps required to collect blood culture samples. By providing the integrated catheter device 200 with a vent access port 210, a physician or nurse can eliminate the need for the additional step and contamination risk of collecting a discarded blood sample prior to collecting a blood culture sample.

[0027] 1 and 2, according to one non-limiting embodiment or aspect of the present disclosure, a method of taking a blood culture sample from a patient using an integrated catheter device 200 is described. According to this method, a catheter 202 may first be inserted into a patient. Upon insertion into a patient, the catheter 202 of the integrated catheter device 200 may exhibit an initial flashback of blood, including an initial volume of blood being sent through a connection port 211 into an extension tube 212. The initial volume of blood may be directed into a vent plug 216 held by a luer adapter 215. The initial volume of blood is sent through the extension tube 212, and the vent plug 216 may optionally be used to vent air from the extension tube 212 via a vent 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 integrated catheter device 200. After an initial volume of blood has been directed through vent access port 210, catheter 202 may direct a blood culture sample through integrated catheter device 200 and out distal access port 208 to blood culture sample collection tube 213. After receiving a desired volume of the blood culture sample from distal access port 208, blood culture sample collection tube 213 may be detached from integrated catheter device 200 and the blood culture sample may be analyzed.

[0028] In one embodiment, during initial insertion of the catheter 202, due to venous blood pressure, an initial volume of blood enters the vent access port 210 at the proximal end of the fluid path of the integrated catheter device 200 and the extension tube 212. The initial volume of blood can enter the integrated catheter device 200 through the catheter 202, which can be connected to the integrated catheter device 200 via an adapter 204. The initial volume of blood can pass through an insta-flash notch defined in the catheter 202, or through the interior space between the catheter 202 and a separate flashback structure or needle. The initial volume of blood then continues through the catheter 202 and the integrated extension tube. Blood continues to pass through the integrated extension tube 212 with the needle in place and after the needle is removed by air purging until the blood reaches the vent plug 216.

[0029] In one embodiment, when the initial blood volume contacts the vent plug 216, the venting stops and blood flow to the catheter system is stopped. The vent plug 216 may be a membrane, paper, porous material, porous film, or a mechanical mechanism that allows air to pass while stopping fluid from passing. The portion of the blood volume that travels through the vent plug 216, optional adapter 204, and extension tube 212 is the initial blood volume that enters the integrated catheter device 200 during insertion and therefore carries a high risk of introducing skin flora into the blood culture sample. The integrated catheter device 200 uses a configuration that isolates this initial blood volume to significantly reduce the chance of contaminating the blood culture sample with microorganisms introduced from 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 may be operatively connected to the distal access port 208 via an extension tube 220. The extension tube 220 may be integral with the luer lock adapter device 206 or may be removably connected to the luer lock adapter device 206. The extension tube 220 allows for increased flexibility during blood draw to place the blood culture sample collection tube 213 in an upright position during blood draw. The overall fluid path of the extension tube 220 may be optimized to reduce hemolysis during the blood culture sample collection step and / or the subsequent evacuated tube or syringe-based blood sample collected after the blood culture sample is collected. In one embodiment, the overall fluid path of the extension tube 220 may include a HemoShield fluid path. In one embodiment, an example of a hemo-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] Referring to FIG. 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 sent through the extension tube 212, and the other port 228 of the dual port luer adapter 222 may hold a vent plug 216. In some embodiments, the proximal luer adapter provided at the end 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 with an integrated extension tube to create a sterile blood collection convenience kit for receiving an isolated blood volume 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 may be used with one of the ports vented with the internal volume of the vent port, the vent plug 216, larger than the isolated blood volume required, and the other port 228 reserved for blood culture sampling. In this type of use, the vent plug 216 gets wet when a blood culture sample is being collected from the other port 228, preventing air from entering the system.

[0032] In other embodiments or aspects of the disclosure, the clamp member 218 may be a pinch clamp, a slide clamp, a roller clamp, or a stopcock style clamp, among other types of clamps. The initial blood volume may be isolated within the extension tube 212 using a one-way vent / fluid valve proximate the vent access port 210. The initial blood volume may also be isolated within the extension tube 212 using a venting material that prevents air from entering the integrated catheter device 200 under vacuum during the sample collection step. The luer lock adapter device 206 or a feature on the extension tube 220 may occlude the extension tube 212.

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

[0034] The present disclosure offers many unique advantages over current blood culture sample collection devices. The number of needle sticks required for 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. All devices used are sterile packaged, reducing the risk of contamination of the blood culture sample. The integrated catheter device 200 may also provide passive blood separation, including passive or manual (clamp) diverted blood separation. By diverting the initial blood volume, the need for a blood discard sample is eliminated, as well as the need for a sterile blood discard sample. The use of the integrated catheter device 200 also reduces steps in the blood culture sample collection process, improving the physician or nurse workflow by reducing the number of connections, reducing contamination changes during blood culture sample collection. Connection to the luer lock adapter device 206 allows for vacuum tube blood draw immediately following blood culture sample collection from the patient. The integrated catheter device 200 also provides an optimized fluid path to reduce hemolysis in subsequent blood draw 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. An integrated catheter comprising: a body defining a channel for conducting a biological fluid therethrough; a connection port defined in the body, an extension tube fluidly coupled to the connection port; a distal access port defined in the body; a vent access port in fluid communication with the extension tube, the vent access port being spaced from the connection port, such that an initial volume of biological fluid directed through the body is directed through the extension tube to the vent access port; an integrated catheter operably connected to the body; An integrated catheter comprising:

2. The integrated catheter of claim 1 , further comprising a catheter adapter, the integrated catheter being operatively connected to the body via the catheter adapter.

3. The integrated catheter of claim 2 , further comprising a stabilizing platform operatively connected to the catheter adapter for stabilizing the integrated catheter on a desired surface.

4. The integrated catheter of claim 1 , further comprising a Luer adaptor, the vent access port being integral with the Luer adaptor.

5. The integrated catheter of claim 4, further comprising a vent plug integrated with at least one of the luer adapter and the vent access port.

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

7. The integrated catheter of claim 1 , including a clamping member disposed about a portion of the extension tube, wherein in a clamped position, the clamping member is configured to occlude at least a portion of the extension tube.

8. The integrated catheter of claim 1 , further comprising a luer lock access device fluidly connected to the distal access port.

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

10. 1. An integrated catheter comprising: a body defining a channel for conducting a biological fluid therethrough; a connection port defined in the body, an extension tube fluidly coupled to the connection port; a vent access port in fluid communication with the extension tube, the vent access port being spaced from the connection port; an integrated catheter operatively connected 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 An integrated catheter, wherein an initial volume of biological fluid directed through the body is routed through the connection port into the extension tube and directed into the vent access port.

11. The integrated catheter of claim 10 , wherein an initial volume of blood is directed into the vent access port, after which a portion of the biological fluid is directed into the removable sample collection container.

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

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

14. The integrated catheter of claim 10 , further comprising a catheter adapter, the integrated catheter being operatively connected to the body via the catheter adapter.

15. The integrated catheter of claim 14, further comprising a stabilizing platform operatively connected to the catheter adapter for stabilizing the integrated catheter on a desired surface.

16. The integrated catheter of claim 10, further comprising a luer adaptor, the vent access port being integral with the luer adaptor.

17. The integrated catheter of claim 16, further comprising a vent plug integrated with at least one of the luer adapter and the vent access port.

18. The integrated catheter of claim 10 , including a clamping member disposed about a portion of the extension tube, wherein in a clamped position, the clamping member is configured to occlude at least a portion of the extension tube.

19. The integrated catheter of claim 10, further comprising a luer lock access device fluidly connected to the distal access port.

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

21. 1. A method of collecting a biological fluid sample, comprising: providing an integrated catheter including: a body defining a channel for conducting a biological fluid therethrough; a connection port defined in the body, wherein an extension tube is fluidly coupled to the connection port; a vent access port in fluid communication with the extension tube, the vent access port being spaced apart from the connection port; and a distal access port defined in the body, the distal access port configured to be in fluid communication with a removable sample collection container; receiving an initial volume of the biological fluid within the integrated catheter; directing the initial volume of the biological fluid through the connection port and into the extension tube fluidly connected to the connection port; venting air from the initial volume of biological fluid via a vent access port operatively connected to the extension tube; closing the extension tube; A method comprising:

22. 22. The method of claim 21, further comprising collecting a subsequent volume of biological fluid from the integrated catheter into a blood culture sample collection tube.

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