Confirmation of intravenous catheter placement

Abstract

The catheter system includes a catheter adapter, the adapter having a distal end and a proximal end. The catheter system includes a catheter, the catheter may have a distal end, a proximal end, a catheter lumen extending through the distal end of the catheter and the proximal end of the catheter, and an inner surface forming the catheter lumen. The catheter may extend distally from the distal end of the catheter adapter. The distal end of the catheter may include one or more holes. The distal end of the catheter may include one or more channels. The holes and / or channels may facilitate visualization of vascular flashback, indicating that the catheter has been placed within a patient's vein.

Description

Technical Field

[0005] ,

[0004] , , , ,

[0006]

[0001] The present disclosure generally relates to vascular access devices and related systems and methods.

Background Art

[0002] Catheters are commonly used in various infusion therapies. For example, a catheter can be used to infuse fluids such as normal saline, various medications, and total parenteral nutrition into a patient. A catheter can also be used to draw blood from a patient.

[0003] A common type of catheter is an over-the-needle peripheral intravenous catheter ("PIVC"). As its name implies, an over-the-needle PIVC is attached over an introducer needle having a sharp distal tip. The PIVC and the introducer needle can be assembled such that the distal tip of the introducer needle is angled outward from the patient's skin and extends beyond the distal tip of the PIVC. The PIVC and the introducer needle are generally inserted at a shallow angle through the skin into the patient's vein.

[0004] To confirm proper placement of the introducer needle and / or PIVC into the blood vessel, a clinician generally checks for a "flashback" of blood. More specifically, in some instances, the introducer needle can include a notch. As the sharp distal tip of the introducer needle is placed within the patient's vascular structure, blood flows proximally through the lumen of the introducer needle and exits the lumen of the needle through the notch.

[0005] Next, the blood can move proximally between the outer surface of the introducer needle and the inner surface of the PIVC, which can be transparent. Thus, the clinician can visualize the blood and thereby confirm the placement of the introducer needle within the vascular structure. Once the needle placement is confirmed, the clinician temporarily impedes the flow within the vein, removes the introducer needle, and leaves the PIVC in the same position for further blood draws and / or fluid infusions.

[0006] The subject matter claimed herein is not limited to embodiments that resolve any disadvantages or embodiments that operate only in environments such as those described above. Rather, this background art is provided only to illustrate an example of a technical area in which some of the devices described herein may be implemented. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent Application No. 15 / 946,593 [Patent Document 2] U.S. Patent Application No. 15 / 286,261 [Overview of the project]

[0008] This disclosure generally relates to vascular access devices and related systems and methods. In some embodiments, a catheter system may include a catheter adapter, which may include a distal end, a proximal end, and a catheter adapter lumen extending through the distal and proximal ends of the catheter. In some embodiments, a catheter system may include a catheter, which may include a distal end, a proximal end, a catheter lumen extending through the proximal ends of the catheter, and an inner surface forming the catheter lumen. In some embodiments, the catheter may extend distally from the distal end of the catheter adapter.

[0009] In some embodiments, the catheter system may include an introduction needle that may extend from the catheter. In some embodiments, the introduction needle may include a sharp distal tip that may be positioned distal to the distal end of the catheter. In some embodiments, the distal end of the catheter may include a distal opening through which the introduction needle may extend.

[0010] In some embodiments, the distal end of the catheter adapter may include one or more holes. In some embodiments, the catheter system may include a gap located between the outer surface of the insertion needle and the inner surface of the catheter. In some embodiments, this gap may be located within the lumen of the catheter. In some embodiments, this gap may be fluid-communicated with the hole so that blood can flow through the hole into the gap as the hole is inserted into a vein. In some embodiments, all or part of the catheter may be transparent, and the gap may include a visualization channel through which blood flows and can be seen by the clinician.

[0011] In some embodiments, the gap may be close to the hole. In some embodiments, the gap may be annular. In some embodiments, the guide needle may include one or more grooves. In some embodiments, the distal end of each groove may be close to an individual hole. In some embodiments, the gap may be located within the groove. In some embodiments, the holes may be arranged such that some of the holes are distal to others.

[0012] In some embodiments, the guiding needle may include a distal end, a proximal end, a guiding needle lumen extending through the distal and proximal ends of the guiding needle, and an inner surface forming the guiding needle lumen. In some embodiments, the catheter system may include one or more sensors. In some embodiments, the sensors may be embedded in the inner surface of the guiding needle at the distal end. In addition, or alternatively, in some embodiments, the sensors may be embedded in the inner surface of the catheter in close proximity to the gap at the distal end.

[0013] In some embodiments, the sensor may be configured to detect whether the distal end of the insertion needle and / or the distal end of the catheter is in a vein. In some embodiments, the sensor may include a bioimpedance sensor, a pressure sensor, a capacitance sensor, an infrared sensor, or other suitable type of sensor. In some embodiments, the pattern or arrangement of the sensors may vary. In some embodiments, the sensor is aligned with the inclination of the distal end of the insertion needle.

[0014] In some embodiments, individual sensors may include bioimpedance sensors comprising a first electrode and a second electrode. In some embodiments, the first electrode may be embedded in the inner surface of the insertion needle at the distal end of the insertion needle, or embedded in the inner surface of the catheter near the gap at the distal end. In some embodiments, the second electrode is configured to be fixed to the patient's skin.

[0015] In some embodiments, the inner surface of the catheter may include one or more channels that may extend from the distal opening. In some embodiments, the channels are configured to allow blood flow between the outer surface of the insertion needle and the inner surface of the catheter as the distal end of the catheter is inserted into the vein.

[0016] In some embodiments, the insertion needle may include a notch. In some embodiments, the outer surface of the insertion needle may include a channel distal to the notch. In some embodiments, the distal end of the channel may be located distal to the distal opening. In some embodiments, the proximal end of the channel may be close to a gap. In some embodiments, the gap may be fluidly connected to the channel so that blood can flow through the channel to the gap as the distal end of the channel is inserted into the vein. In some embodiments, the notch may be close to the gap.

[0017] In some embodiments, the gap may be fluidly connected to the channel and the notch. In some embodiments, the gap may be a first gap, and the catheter system may include a second gap located between the outer surface of the insertion needle and the inner surface of the catheter. In some embodiments, the second gap may be located within the catheter lumen. In some embodiments, the second gap may be fluidly connected to the notch so that, as the insertion needle is inserted into the vein, blood can flow into the insertion needle, out the notch, and into the second gap. In some embodiments, the first gap may be separate from the second gap.

[0018] In some embodiments, the absorbent material may be located within the notch and / or extend proximal within the gap. In some embodiments, the absorbent material may be porous. In some embodiments, the absorbent material may be located proximal to the notch within the lumen of the introduction needle. In some embodiments, as blood comes into contact with the absorbent material, the absorbent material may expand and cover the notch.

[0019] The above general description and the following detailed description are for illustrative and explanatory purposes only and should not be understood as limiting the invention, but rather as described in the claims. It should be understood that various embodiments are not limited to the arrangements and methods shown in the drawings. It should also be understood that embodiments can be combined, or other embodiments can be utilized, and structural variations can be made without departing from the scope of the various embodiments of the invention, unless otherwise claimed. Therefore, the following detailed description should not be taken as limiting.

[0020] Exemplary embodiments are described and explained with reference to the accompanying drawings, along with additional features and details. [Brief explanation of the drawing]

[0021] [Figure 1A] Figure 1A is a top perspective view of one example catheter system according to several embodiments. [Figure 1B] Figure 1B is a cross-sectional view of the catheter system of Figure 1A according to some embodiments. [Figure 2A] Figure 2A is a cross-sectional view of a conventional catheter and a conventional introducer needle disposed at an insertion position according to some embodiments. [Figure 2B] Figure 2B is a cross-sectional view of an example catheter and an example introducer needle disposed at an insertion position according to some embodiments, which can be used in the catheter system of Figure 1A. [Figure 3] Figure 3 is a cross-sectional view of another prior art catheter and another prior art introducer needle disposed at an insertion position according to some embodiments. [Figure 4A] Figure 4A is a top perspective view of an example distal end of the catheter system of Figure 1A according to some embodiments. [Figure 4B] Figure 4B is a bottom perspective view of the distal end of Figure 4A according to some embodiments. <舍 [Figure 4C] Figure 4C is a cross-sectional view of the distal end of Figure 4A according to some embodiments. [Figure 5A] Figure 5A is a bottom perspective view of the distal end of another example catheter according to some embodiments. [Figure 5B] Figure 5B is a cross-sectional view of another example distal end of the catheter system of Figure 1A according to some embodiments. [Figure 6A] Figure 6A is a top perspective view of the distal end of another example catheter according to some embodiments. [Figure 6B] Figure 6B is a cross-sectional view of another example distal end of the catheter system of Figure 1A according to some embodiments, illustrating the catheter of Figure 6A. [Figure 7A] Figure 7A is a cross-sectional view of another example distal end of the catheter system of Figure 1A according to some embodiments, illustrating an example sensor. [Figure 7B] Figure 7B is a cross-sectional view of another distal end of the catheter system of Figure 1A according to some embodiments. [Figure 7C]Figure 7C is an upper perspective view of the distal end of Figure 7B according to several embodiments. [Figure 7D] Figure 7D is a lower perspective view of the distal end of Figure 7B according to several embodiments. [Figure 7E] Figure 7E is a cross-sectional view of the distal end of another example of the catheter system of Figure 1A, according to several embodiments. [Figure 7F] Figure 7F is a top perspective view of the catheter system of Figure 1A inserted into a patient, according to several embodiments, illustrating one example of a sensor. [Figure 8A] Figure 8A is a distal end cross-sectional view of another example of the catheter system of Figure 1A, according to several embodiments. [Figure 8B] Figure 8B is a cross-sectional view of the distal end of another example of the catheter system of Figure 1A, according to several embodiments. [Figure 8C] Figure 8C is a cross-sectional view of the distal end of Figure 8B along the line 8C-8C in Figure 8B, according to several embodiments. [Figure 8D] Figure 8D is a cross-sectional view of the distal end of another example of the catheter system of Figure 1A, according to several embodiments. [Figure 9A] Figure 9A is a cross-sectional view of the distal end of another example of the catheter system of Figure 1A, according to several embodiments, illustrating an example of an absorbent material. [Figure 9B] Figure 9B is a cross-sectional view of the distal end of another example of the catheter system of Figure 1A, according to several embodiments, illustrating the absorbent material at the first position. [Figure 9C] Figure 9C is a cross-sectional view of the distal end of Figure 9B according to several embodiments, illustrating the absorption material at the second position. [Figure 10A] Figure 10A is an upper perspective view of the distal end of another example of the catheter system of Figure 1A, according to several embodiments. [Figure 10B] Figure 10B is a cross-sectional view of the distal end of Figure 10A along the line 10B-10B in Figure 10A, according to several embodiments. [Figure 10C]Figure 10C is a cross-sectional view of the distal end of another example of the catheter system of Figure 1A, according to several embodiments. [Figure 11A] Figure 11A is a top perspective view of an example of an introduction needle according to several embodiments. [Figure 11B] Figure 11B is an upper perspective view of the distal end of another example of the catheter system of Figure 1A, according to several embodiments, illustrating the introduction needle of Figure 11A. [Figure 12] Figure 12 is a top perspective view of an example catheter according to several embodiments, illustrating several markings on the catheter. [Figure 13] Figure 13 is a schematic diagram of one example of a catheter insertion method according to several embodiments. [Figure 14] Figure 14 is a schematic diagram of another catheter insertion method and alert patch according to several embodiments. [Modes for carrying out the invention]

[0022] (Description of the embodiment) Referring to Figures 1A-1B, in some embodiments, the catheter system 10 may include a needle assembly 12 and a catheter assembly 14. Figures 1A-1B illustrate catheter systems in an insertion position that allows for insertion into a patient's vein according to some embodiments. In some embodiments, the catheter assembly 14 may include a catheter adapter 16, which may include a distal end 18, a proximal end 20, and a catheter assembly lumen 21 extending through the distal end 18 and the proximal end 20. In some embodiments, the catheter assembly 14 may include a catheter 22 that may include a distal end 24 and a proximal end 26. In some embodiments, the catheter 22 may include a peripheral intravenous catheter ("PIVC"). In some embodiments, the proximal end 26 of the catheter 22 may be fixed within the catheter adapter 16.

[0023] In some embodiments, the needle assembly 12 may include a needle hub 28 that can be removably connected to the catheter adapter 16. In some embodiments, the needle assembly 12 may include an introduction needle 30. In some embodiments, the proximal end of the introduction needle 30 may be fixed within the needle hub 28. In some embodiments, the introduction needle 30 may extend through the catheter 22 when the catheter system 10 is in an insertion position that allows it to be inserted into a patient's vein, as illustrated, for example, in Figures 1A-1B.

[0024] In some embodiments, the needle assembly 12 may include a needle grip 32, which the clinician grasps and moves proximal to withdraw the introduction needle 30 from the vein once the catheter is positioned in the vein. In some embodiments, the catheter system 10 may include an extension tube 34. In some embodiments, the distal end of the extension tube 34 may be connected to a catheter adapter 16, and the proximal end of the extension tube 34 may be connected to an adapter 36.

[0025] In some embodiments, once the introduction needle 30 is removed from the catheter system 10, a fluid injection device is connected to the adapter 36 to deliver fluid to the patient through the catheter 22 inserted into the vein. In some embodiments, a blood collection device is connected to the adapter 36 to collect blood from the patient through the catheter 22 inserted into the vein.

[0026] In some embodiments, the catheter system 10 may be integrated to have an extension tube 34 integrated within the catheter adapter 16, such as the BD NEXIVA® Closed IV Catheter System, the BD NEXIVA® DIFFUSICS® Closed IV Catheter System, the BD PEGASUS® Safety Closed IV Catheter System, or another integrated catheter system. Examples of integrated catheter systems are illustrated in Figures 1A-1B. In some embodiments, the catheter system 10 may be non-integrated and lack the extension tube 34.

[0027] In some embodiments, the catheter system 10 is provided with an outlet to observe blood and facilitate proximal blood flow into the introduction needle 30 and / or catheter 22. In some embodiments, the catheter system 10 is provided with an outlet in any suitable manner. For example, a vent plug 38 may be connected to the adapter 36 during insertion of the catheter assembly 14 into the patient. In some embodiments, the vent plug 38 is permeable to air but not to blood. In some embodiments, the catheter 22, catheter adapter 16, extension tube 34, adapter 36, and vent plug 38 are in fluid communication. As another example, in some embodiments, the needle hub 28 may include a flash chamber, an example of which is described in U.S. Patent Application No. 15 / 946,593 filed April 5, 2018, entitled “Introducer Needle with Notches for Improved Flashback,” (Patent Document 1), which is incorporated herein by reference in its entirety.

[0028] Referring to Figure 2A, the distal end 40 of a conventional catheter 42 and the distal end 44 of a conventional insertion needle 46 are illustrated. As the conventional insertion needle 46 is inserted into the patient's vein 47, blood can flow directly from the sharp distal tip 48 of the conventional insertion needle 46 through the notch 50 of the conventional insertion needle 46 into the annular gap located between the outer surface of the conventional insertion needle 46 and the inner surface of the conventional catheter 42. The conventional catheter 42 may be transparent, allowing the clinician to visualize the blood and confirm that the sharp distal tip 48 of the conventional insertion needle 46 is positioned within the patient's vein 47.

[0029] After confirming that the sharp distal tip 48 is positioned within the patient's vein 47, the clinician is typically instructed to lower the insertion angle and advance the conventional catheter 42 a short distance before withdrawing the conventional needle 46 and inserting the conventional catheter 42, ensuring that the distal end 40 of the conventional catheter 42 is in the vein 47. The distal tip 52 of the conventional catheter 42 is separated from the proximal end of the inclination of the distal end 44 of the conventional needle 46 by a distance called the "lie distance." Since the length of the inclination varies depending on the gauge size of the conventional needle 46, the distance required for the conventional catheter 42 to travel from when the sharp distal tip 48 penetrates the vein until the distal tip 52 of the conventional catheter 42 enters the vein varies depending on the gauge and the lie distance. Many conventional catheter 42 insertions fail because the conventional needle 46 is withdrawn and the conventional catheter 42 is inserted too early.

[0030] Referring to Figure 2B, the distal end 24 of the catheter 22 and the distal end 31 of the introduction needle 30 are illustrated in insertion positions according to several embodiments. In some embodiments, the introduction needle 30 may include a sharp distal tip 48 that may be positioned distal to the distal end 24 of the catheter 22. In some embodiments, the distal end 24 of the catheter 22 may include a distal opening 56, which may include the most distal edge of the catheter 22. In some embodiments, the introduction needle 30 may extend through the distal opening 56.

[0031] In some embodiments, the introduction needle 30 may include a distal end 31, a proximal end, an introduction needle lumen 58 extending through the distal end and proximal end of the introduction needle 30, and an inner surface 60 forming the introduction needle lumen 58. In some embodiments, the wall 61 of the introduction needle 30, including the inner surface 60, may not include a notch.

[0032] In some embodiments, the catheter 22 may include a distal end 24, a proximal end 26, a catheter lumen 62 extending through the distal end 24 and the proximal end 26, and an inner surface 64 forming the catheter lumen 62. In some embodiments, the distal end 24 of the catheter 22 may include one or more holes 66.

[0033] In some embodiments, the gap 68 may be located between the outer surface of the introduction needle 30 and the inner surface 64 of the catheter 22. In some embodiments, the gap 68 may be located within the catheter lumen 62. In some embodiments, the gap 68 may be fluidly connected to the hole 66 so that blood can flow from the hole 66 to the gap 68 as the hole 66 is inserted into the vein 47. In some embodiments, all or part of the catheter 22 may be transparent, and the gap 68 may include a visualization channel through which blood flows and is visible to the clinician. In some embodiments, the gap 68 may be close to the hole 66. In some embodiments, the gap 68 may be annular.

[0034] Referring to Figure 3, the conventional catheter 70 may be mounted on a conventional introduction needle 72 so that blood does not enter the conventional catheter 70 at its distal end. This may prevent the clinician from accurately determining whether the conventional catheter 70 is in the patient's vein. In some embodiments, the land portion 71 of the conventional catheter 70 may be cylindrical.

[0035] Referring to Figures 4A-4C, in some embodiments, the inner surface 64 of the catheter 22 may include a land portion 74 that is close to the distal opening 56 and close to the gap 68. In some embodiments, the diameter of the land portion 74 is approximately equal to the outer diameter of the introduction needle 30, thereby causing the land portion 74 to contact the introduction needle 30. In some embodiments, the hole 66 may be located within the land portion 74, and the clearance 76 may connect the gap 68 to the hole 66. In some embodiments, the hole 66 and / or gap 68 may be located at the top of the catheter 22, opposite the sharp distal tip 48. In some embodiments, the hole 66 and / or gap 68 may be located at the bottom of the catheter 22, on the same side as the sharp distal tip 48, to facilitate rapid identification that the catheter 22 is in a vein. In some embodiments, the hole 66 and / or gap 68 may be located between the top and bottom of the catheter 22.

[0036] Referring to Figures 5A-5B, in some embodiments, the hole 66 may be extended so that its proximal end is positioned close to the land portion 74. In these and other embodiments, the clearance 76 (see, for example, Figure 4C) may not be present. In some embodiments, the hole 66 may be close to the gap 68.

[0037] Referring to Figures 6A-6B, in some embodiments, the inner surface 64 of the catheter 22 may include one or more channels 78 that may extend from the distal opening 56. In some embodiments, the channels 78 may be configured to allow blood to flow between the outer surface of the introduction needle 30 and the inner surface 64 of the catheter 22 as the distal end 24 of the catheter 22 is inserted into a vein. In some embodiments, blood may flow from the vein through the channels 78 into the gap 68. In some embodiments, a portion of the distal opening may come into contact with the introduction needle 30 between the channels 78.

[0038] Referring to Figure 7A, in some embodiments, a catheter system, such as the catheter system 10 in Figures 1A-1B, may include one or more sensors 80. In some embodiments, the sensor 80 may be embedded in the inner surface 60 of the introduction needle 30 at the distal end 31 of the introduction needle 30. In some embodiments, the sensor 80 may be positioned close to the lumen 58 of the introduction needle and configured to come into contact with the blood moving within the introduction needle 30.

[0039] In some embodiments, the sensor 80 may be configured to detect when the distal end 31 of the introduction needle 30 is in a vein. In some embodiments, the sensor 80 may be configured to detect when the distal end of the introduction needle 30 is withdrawn and / or partially withdrawn from the vein. In some embodiments, the sensor 80 may include a bioimpedance sensor, a pressure sensor, a capacitance sensor, an infrared sensor, or another suitable type of sensor. In some embodiments, the pattern and arrangement of the sensor 80 may vary.

[0040] In some embodiments, the sensor 80 may be connected to one or more lead wires 86 that can be embedded in the introduction needle 30. In some embodiments, the lead wires 86 may connect the sensor 80 to a monitor which may include a processor. The sensor 80 can be combined with any embodiment of this application and may facilitate the detection of the catheter 22 in the vein after the introduction needle 30 has been detected in the vein via the sensor 80.

[0041] Referring to Figures 7B to 7D, multiple sensors 80 are illustrated according to several embodiments. In some embodiments, the sensors 80 may include bioimpedance sensors, each of which may include two or more electrodes 84. In some embodiments, individual bioimpedance sensors may include a first electrode 84a and a second electrode 84b (which may be collectively referred to as "electrode 84"). In some embodiments, the electrodes 84 may be separated by a predetermined distance, generally perpendicular to the longitudinal axis. In some embodiments, the direction or orientation of the distance separating the electrodes 84 may vary.

[0042] In some embodiments, as the introduction needle 30 advances into the patient, an electric current is applied to the bioimpedance sensor, and the impedance across the electrode 84 is continuously measured. In some embodiments, it may be determined that the distal end 31 of the introduction needle 30 is placed intravenously based on the impedance measured between the electrodes 84. In some embodiments, it may be determined that the distal end 31 of the introduction needle 30 is placed intravenously depending on whether the measured impedance is above or below a threshold, or whether the change in the measured impedance exceeds another threshold.

[0043] In some embodiments, an alert may be issued in the catheter system or elsewhere when it is determined that the distal end 31 of the introduction needle 30 has been placed in a vein. In some embodiments, an alert may be issued in the catheter system or elsewhere when it is determined that the distal end 31 of the introduction needle 30 has been withdrawn or partially withdrawn from the vein. In some embodiments, the alert may include a visual alert or an audible alert. In some embodiments, the alert may include a light, an example of which will be discussed later in relation to Figure 14.

[0044] In some embodiments, the sensor 80 may be aligned with the inclination of the distal end 31 of the introduction needle 30. In some embodiments, the sensors 80 may be arranged in a zigzag pattern or spaced apart along the longitudinal axis. In some embodiments, one or more sensors 80 may be positioned more proximal to one or more other sensors 80. In some embodiments, the arrangement of the sensors 80 facilitates the clinician in identifying the depth to which the introduction needle 30 and / or catheter 22 is inserted into the vein. In some embodiments, the clinician may remove the introduction needle 30 from the catheter 22 in response to one or more sensors 80 detecting that the catheter 22 is in the vein.

[0045] Referring to Figure 7E, in some embodiments, the sensor 80 may be embedded in the outer surface of the catheter 22 at the distal end 24 of the catheter 22, close to the gap 68. In some embodiments, the introduction needle 30 may include a notch 88 that may be positioned adjacent to and / or close to the distal opening 56. In some embodiments, the sensor 80 is configured to come into contact with blood in the vein when the catheter 22 is in a vein.

[0046] In some embodiments, the sensors 80 are arranged in a zigzag pattern or spaced apart along the longitudinal axis. In some embodiments, one or more sensors 80 are positioned more proximal to one or more other sensors 80. In these embodiments, the arrangement of the sensors 80 facilitates the clinician in identifying the depth to which the catheter 22 is inserted into the vein. In some embodiments, the sensors 80 can facilitate the confirmation of one or more positions of the catheter 22 with respect to the vein, for example, the positions discussed in relation to Figure 14, i.e., the catheter entering the vein, the catheter 22 being further advanced into the vein, and the catheter being fully inserted into the vein. In some embodiments, multiple sensors 80 may be embedded in the outer surface of the catheter 22, or one sensor 80 may be embedded in the outer surface of the catheter 22.

[0047] In some embodiments, the sensor 80 may be configured to detect when the distal end 24 of the catheter 22 is in a vein. In some embodiments, the sensor 80 may be configured to detect when the distal end 24 of the catheter 22 is withdrawn or partially withdrawn from the vein. In some embodiments, while the catheter 22 and introduction needle 30 are advanced into the patient, an electric current may be applied to the bioimpedance sensor, and the impedance across the electrode 84 may be continuously measured. In some embodiments, it may be determined that the distal end 24 of the catheter 22 is positioned in a vein based on the impedance measured between the electrodes.

[0048] In some embodiments, it may be determined whether the distal end 24 of the catheter 22 is placed in a vein, depending on whether the measured impedance exceeds or falls below a threshold, or whether a change in the measured impedance exceeds another threshold. In some embodiments, an alert may be issued to the catheter system or another location depending on whether it is determined that the distal end 24 of the catheter 22 is placed in a vein. In some embodiments, an alert may be issued to the catheter system or another location depending on whether it is determined that the distal end 24 of the catheter 22 is withdrawn or partially withdrawn.

[0049] Referring to Figure 7F, in some embodiments, the individual sensors 80 may include a bioimpedance sensor that may include a first electrode 84a and a second electrode 84b. In some embodiments, the first electrode 84a may be embedded in the inner surface 68 of the introduction needle 30 at the distal end 31 of the introduction needle 30, or embedded in the outer surface of the catheter 22 close to the gap 68 at the distal end 24. In some embodiments, the second electrode 84b may be configured to be fixed to the patient's skin as a reference point.

[0050] In some embodiments, it may be determined whether the introduction needle 30 and / or catheter 22 are placed in a vein, depending on whether the impedance measured by the electrode 84 turns exceeds or falls below a threshold, or whether the change in the measured impedance exceeds another threshold.

[0051] Referring to Figure 8A, in some embodiments, the introduction needle 30 may include a notch 88. In some embodiments, the outer surface of the introduction needle 30 may include a channel 90 distal to the notch 88. In some embodiments, the distal end 92 of the channel 90 may be located distal to the distal opening 56. In some embodiments, the proximal end 94 of the channel 90 may be located proximal to the distal opening 56 and / or close to the gap 68. In some embodiments, the gap 68 may be in fluid communication with the channel 90 so that blood can flow through the channel 90 to the gap 68 as the distal end 92 of the channel 90 is inserted into the vein. In some embodiments, the notch 88 may be close to the gap 68. In some embodiments, the gap 68 may be in fluid communication with the channel 90 and the notch 88.

[0052] In some embodiments, the notch 88 and channel 90 can facilitate the visualization of two blood flashbacks by the clinician, one of which indicates intravenous insertion of the introduction needle 30 and the other indicating intravenous insertion of the catheter 22. In some embodiments, the notch 88 may be positioned more proximal than the notch 50 of the prior art introduction needle 46 (e.g., illustrated in Figure 2A), which can prevent the clinician from confusing the two blood flashbacks. In some embodiments, the notch 88 may be positioned in the middle of the introduction needle 30 or towards its proximal end. In some embodiments, the length of the channel 90 is adjusted so that the blood flowing through the channel 90 indicates that the introduction needle 30 is obscured. In some embodiments, the notch 88 may be located within the catheter adapter 16.

[0053] Referring to Figures 8B-8C, in some embodiments, the first gap 68a may be separated from the second gap 68b. In some embodiments, the second gap 68b may also be located between the outer surface of the introduction needle 30 and the inner surface 64 of the catheter 22. In some embodiments, the second gap 68b may be located within the catheter lumen 62. In some embodiments, the second gap 68b may be in fluid communication with the notch 88 so that, as the introduction needle 30 is inserted into the vein, blood flows into the introduction needle 30, out of the notch 88, and into the second gap 68b. In some embodiments, the first gap 68a and the second gap 68b prevent confusion between an indicator that the catheter 22 is in the vein and an indicator that the introduction needle 30 is in the vein.

[0054] Referring to Figure 8D, in some embodiments, the catheter 22 may be asymmetrical. An example of an asymmetrical catheter is described in U.S. Patent Application No. 15 / 286,261 (Patent Document 2), filed on October 5, 2016, entitled "Catheter with an Asymmetric Tip," which is incorporated herein by reference in its entirety.

[0055] Referring to Figure 9A, in some embodiments, the absorbent material 96 may be positioned within the notch 88 and / or extend distally within the gap 68. In some embodiments, the absorbent material 96 may be porous. In some embodiments, the absorbent material 96 may turn red when in contact with blood, providing a quick indicator of venous entry by the introduction needle 30. In some embodiments, the absorbent material 96 may prevent blood exiting the notch 88 from flowing distally through the gap 68, which prevents mixing of blood moving proximal through the channel 90 with blood exiting the notch 88, facilitating distinction and decision-making when withdrawing the introduction needle 30 and inserting the catheter 22.

[0056] Referring to Figures 9B-9C, in some embodiments, the absorbent material 96 may be positioned proximal to the notch 88 within the lumen 58 of the introduction needle. In some embodiments, the absorbent material 96 may extend along the outer surface of the introduction needle 30.

[0057] In some embodiments, the absorbent material 96 may be porous. Figure 9B illustrates the absorbent material 96 before contact with blood according to some embodiments. Figure 9C illustrates the absorbent material after contact with blood according to some embodiments.

[0058] In some embodiments, as blood comes into contact with the absorbent material, the absorbent material 96 may expand or swell to cover the notch 88. In some embodiments, once the notch 88 is covered with the absorbent material 96, the notch 88 may be closed after some initial blood has flowed from the notch 88 into the gap 68. In some embodiments, the closure of the notch 88 may prevent mixing of blood moving proximal through the channel 90 with the blood in the introduction needle 30, facilitating distinction and decision-making when withdrawing the introduction needle 30 and inserting the catheter 22.

[0059] Referring to Figure 10, in some embodiments, the catheter 22 may include multiple lumens. For example, the catheter 22 may include a catheter lumen 62 and one or more other lumens 98. In some embodiments, the other lumens 98 may be located within the wall of the catheter 22. In some embodiments, the distal end of each of the other lumens 98 may include a hole 100 that can extend through a portion of the wall of the catheter 22. In some embodiments, the proximal end of each of the other lumens 98 may include another hole 102, which may drain into the gap 68 and allow for the discharge of the other lumens 98.

[0060] In some embodiments, the catheter lumen 62 is larger than the other lumen 98 to facilitate infusion therapy through the catheter lumen 62. In some embodiments, the other lumen 98 may be located at the top of the catheter 22 opposite the sharp distal tip 48, which may facilitate visualization of blood in the other lumen 98. In some embodiments, the other lumen 98 may be located at the bottom of the catheter 22. In some embodiments, the other lumen 98 may be located between the top and bottom of the catheter 22, which also facilitates visualization of blood in the other lumen 98.

[0061] In some embodiments, the holes 100 and / or other lumens 98 may be arranged in a zigzag pattern or spaced apart along the longitudinal axis. For example, the first hole 100a and / or the first other lumen 98a may be located closer to the second hole 100b and / or the second other lumen 98b, as illustrated, for example, in Figure 10A. In some embodiments, the spacing of the holes 100 may facilitate the clinician in determining the depth to which the catheter 22 is inserted into the vein. In some embodiments, the clinician may remove the introduction needle 30 from the catheter 22 in response to visualization of blood in one or more other lumens 98.

[0062] Referring to Figures 11A-11B, in some embodiments the introduction needle 30 may include one or more grooves 103. In some embodiments, the distal end 104 of each groove 103 may be adjacent to individual holes 66 that may extend through the wall of the catheter 22. In some embodiments, gaps 68 may be located within the individual grooves 103. In some embodiments, the proximal end 106 of each hole 66 may be aligned with a gap 68.

[0063] In some embodiments, the holes 66 are arranged such that some of the holes 66 are distal to others. In some embodiments, the holes 66 and / or grooves 103 may be arranged in a zigzag pattern or spaced apart along the longitudinal axis. In some embodiments, the spacing of the holes 66 facilitates the clinician in determining the depth to which the catheter 22 is inserted into the vein. In some embodiments, the clinician can remove the introduction needle 30 from the catheter in response to visualization of blood in one or more grooves 103.

[0064] In some embodiments, the groove 103 can be located at the top of the catheter 22 opposite the sharp distal tip 48, which may facilitate the visualization of blood within the groove 103. In some embodiments, the groove 103 can be located at the bottom of the catheter 22. In some embodiments, the groove 103 can be located between the top and bottom of the catheter 22, which may also facilitate the visualization of blood within the groove 103.

[0065] Referring to Figure 12, in some embodiments, the outer surface of the catheter 22 may include one or more markings 108 which change gradually to indicate the depth of insertion of the catheter 22 into the vein to the clinician. In some embodiments, the clinician may advance the catheter 22 through several markings 108 and attach the catheter 22 forward away from the introduction needle 30. In some embodiments, the markings 108 may be evenly spaced. In some embodiments, the markings 108 may include lines that are approximately perpendicular to the longitudinal axis of the catheter 22. In some embodiments, the clinician may insert the catheter 22 so that each marking 108 aligns with or is at the same height as the outer surface of the patient's skin. In some embodiments, as each marking 108 aligns with the patient's skin, it may indicate to the clinician that the catheter 22 is being inserted into the vein. More specifically, as the individual markings 108 align with the patient's skin, they may indicate to the clinician that the catheter 22 is entering the vein or that the catheter 22 is fully inserted into the vein. In some embodiments, the catheter 22 may enter the vein when the vein wall is completely penetrated by the catheter 22. In some embodiments, the catheter 22 may be fully inserted into the vein when the catheter 22 is ready for use in infusion or blood sampling, etc.

[0066] In some embodiments, the catheter 22 may be inserted into the vein by a first amount or a first depth corresponding to the catheter 22 entering the vein, as the first marking 108 aligns with the outer surface of the patient's skin. In some embodiments, the catheter 22 may be inserted by a second amount or a second depth corresponding to the complete insertion of the catheter 22 into the vein, as the second marking 108 aligns with the outer surface of the patient's skin. In some embodiments, the second marking 108 may be more proximal to the first marking 108.

[0067] In some embodiments, the individual catheter system may include one or more of the following: a first position indicator, a second position indicator, and a third position indicator. In some embodiments, the first position indicator may include one or more of the notches 50, 88, absorbent material 96, or one or more sensors 80 as shown in the preceding figure. In some embodiments, blood flowing through or in contact with the first position indicator may indicate to the clinician that the introduction needle 30 has been inserted into the vein. In some embodiments, insertion of the introduction needle 30 into the vein may include the entry of the introduction needle 30 into the vein or the penetration of the vein wall by the introduction needle 30.

[0068] In some embodiments, the second position indicator may include one or more holes 66 in the catheter 22 that are fluidly communicating with the gap 68, one or more channels 78 that are fluidly communicating with the gap 68, one or more sensors 80 in the catheter 22, one or more other lumens 98 that are fluidly communicating with the individual holes 100, one or more grooves 103, each adjacent to an individual hole 66, or one or more markings 108. In some embodiments, the second position indicator may include the first markings 108, and the alignment of the second position indicator with the outer surface of the patient's skin may indicate to the clinician that the catheter 22 has been inserted into the vein by a first volume or a first depth. In some embodiments, blood flowing through or in contact with the second position indicator may indicate to the clinician that the catheter 22 has been inserted into the vein by a first volume or a first depth. In some embodiments, the catheter 22 may be inserted into the vein by a first volume or a first depth, depending on whether blood flows through or comes into contact with the indicator at the second position, or whether the outer surface of the skin aligns with the indicator at the second position.

[0069] In some embodiments, the third position indicator may include one or more holes 66 of the catheter 22 that are in fluid communication with the gap 68, one or more sensors within the catheter 22, one or more other lumens 98 that are in fluid communication with the individual holes 100, one or more grooves 103 adjacent to each individual hole 66, or one or more markings 108. In some embodiments, the third position indicator may include a second marking 108, and alignment of the third position indicator with the outer surface of the patient's skin can indicate to the clinician that the catheter 22 has been inserted intravenously to a second volume or second depth. In some embodiments, blood flowing through or in contact with the third position indicator may indicate that the catheter 22 has been inserted intravenously to a second volume or second depth. In some embodiments, the catheter 22 may be inserted into the vein in a second volume or to a second depth, depending on whether blood flows through or comes into contact with the indicator at the third position, or whether the indicator at the third position aligns with the outer surface of the skin.

[0070] Referring to Figure 13, in some embodiments, a clinician may observe a first flashback 110 corresponding to the entry of the vein needle 30, followed by a second flashback 112 corresponding to the entry of the catheter 22 into the vein. In some embodiments, the first blood flashback 110 may be visible to the clinician in the flash chamber within the catheter system or at another suitable location. In some embodiments, the second blood flashback 112 may be visible to the clinician in a gap between the catheter 22 and the vein needle 30, such as a gap 68 discussed with respect to at least Figures 2B and 4-10 of this application.

[0071] Referring to Figure 14, in some embodiments, the alert patch 114 may be attached to the patient's skin. In some embodiments, the alert patch 114 is configured to provide alerts, which may be further described with respect to Figures 7B–7D. In some embodiments, the alert patch 114 is configured to provide the patient with individual alerts based on the insertion stage of the catheter assembly.

[0072] In some embodiments, the alert patch 114 may be configured to give one or more of the following alerts: a first alert, a second alert, a third alert, and a fourth alert. In some embodiments, the alert patch 114 may be configured to give a first alert in response to the introduction needle 30 piercing or entering the vein. In some embodiments, the alert patch 114 may be configured to give a second alert in response to the catheter 22 entering the vein. In some embodiments, the alert patch 114 may give a third alert in response to the catheter 22 being further advanced into the vein. In some embodiments, the alert patch 114 may be configured to give a fourth alert in response to the catheter 22 being fully inserted into the vein, and this alert may be a signal that the introduction needle 30 may be removed from the catheter 22. In some embodiments, each of the first, second, third, and fourth alerts may include a different light, which may be activation, flashing, stopping flashing, changing color, etc.

[0073] In some embodiments, while a clinician physically inserts the catheter assembly, the alert patch 114 can facilitate easy visualization of the stages of catheter assembly insertion. In some embodiments, one or more alerts may change or terminate in response to one or more of the following: the introduction needle is no longer in the vein, the catheter 22 is no longer in the vein, or the catheter 22 is no longer fully inserted into the vein.

[0074] Again, the embodiments of this application can be combined. For example, the embodiments in Figures 8A to 8D may include one or more holes 66 (e.g., illustrated in Figures 2B, 4 to 5 and 7) in addition to or as alternatives to one or more channels 90. Another example is the embodiments in Figures 9A to 9C, which may include one or more holes 66 (e.g., illustrated in Figures 2B, 4 to 5 and 7) in addition to or as alternatives to one or more channels 90.

[0075] All examples and conditional terms cited herein are intended for educational purposes to help the reader understand the inventions and concepts proposed by the inventors to further advance the Art, and should be construed as not being limited to such specifically cited examples and conditions. Although embodiments of the Invention are described in detail, it should be understood that various substitutions, replacements, and modifications can be made to such embodiments without departing from the spirit and scope of the Invention.

Claims

1. A catheter adapter including a distal end and a proximal end, A catheter comprising a distal end, a proximal end, a catheter lumen extending through the distal end and the proximal end of the catheter, and an inner surface forming the catheter lumen, wherein the catheter extends distally from the distal end of a catheter adapter, and the distal end of the catheter includes a hole, An introduction needle that extends through a catheter, including an introduction needle with a sharp distal tip, A gap is located within the lumen of the catheter between the outer surface of the introduction needle and the inner surface of the catheter, wherein the gap is fluidly communicating with the hole so that blood can flow from the hole to the gap as the hole is inserted into the vein. Includes, The introduction needle includes a distal end, a proximal end, an introduction needle lumen extending through the distal end and the proximal end of the introduction needle, and an inner surface forming the introduction needle lumen, and further includes a sensor embedded in the inner surface of the introduction needle at the distal end of the introduction needle, the sensor being configured to detect that the distal end of the introduction needle is in a vein. The aforementioned sensor is a catheter system including a bioimpedance sensor, a capacitance sensor, or an infrared sensor.

2. The catheter system according to claim 1, wherein the gap is annular.

3. The catheter system according to claim 1, wherein the introduction needle includes a groove, the distal end of the groove is close to a hole, and the gap is located within the groove.

4. The catheter system according to claim 3, wherein the hole is a first hole, the groove is a first groove, the distal end of the catheter includes a second hole, the second hole is more proximal to the first hole, and the distal end of the second groove is close to the second hole.

5. The catheter system according to claim 1, further comprising a plurality of other sensors, wherein the sensor and the plurality of other sensors include bioimpedance sensors, and the sensor and the plurality of other sensors are aligned with the inclination of the introduction needle.

6. The catheter system according to claim 1, further comprising a sensor embedded in the outer surface of the catheter near the gap at the distal end of the catheter, wherein the sensor is configured to detect that the distal end of the catheter is in a vein.

7. The catheter system according to claim 6, wherein the sensor includes a bioimpedance sensor, a pressure sensor, a capacitance sensor, or an infrared sensor.

8. The catheter system according to claim 1, wherein the introduction needle includes a distal end, a proximal end, an introduction needle lumen extending through the distal end and the proximal end of the introduction needle, and an inner surface forming the introduction needle lumen, further comprising a bioimpedance sensor, the bioimpedance sensor including a first electrode and a second electrode, the first electrode being embedded in the inner surface of the introduction needle at the distal end of the introduction needle, or in the outer surface of the catheter at the distal end of the catheter within the gap, and the second electrode being fixed to the patient's skin.

Images