Guidewire assemblies and intravenous catheter devices

JP7939960B2Active Publication Date: 2026-10-22BECTON DICKINSON & CO
View PDF 5 Cites 0 Cited by

Patent Information

Application Number
JP2023573198
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-05-27
Filing Date
2022-05-26
Publication Date
2026-10-22
Estimated Expiration
2042-05-26

Smart Images

  • Figure 0007939960000001
    Figure 0007939960000001
  • Figure 0007939960000002
    Figure 0007939960000002
  • Figure 0007939960000003
    Figure 0007939960000003
Patent Text Reader

Abstract

The intravenous catheter device can include a guidewire for actively repositioning the catheter tip. The guidewire assembly can be configured to allow a clinician to actively reposition the catheter tip by moving a proximal end of a segment of the guidewire. By repositioning the catheter tip, the guidewire assembly can facilitate the withdrawal of a blood sample or the injection of a fluid through the catheter, even if the catheter tip is blocked.
Need to check novelty before this filing date? Find Prior Art

Description

TECHNICAL FIELD

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 194,050, filed May 27, 2021, entitled "INTRAVENOUS CATHETER DEVICE WITH GUIDEWIRE FOR ACTIVELY REPOSITIONING CATHETER TIP", the entire disclosure of which is incorporated herein by reference.

BACKGROUND ART

[0002] Intravenous (IV) catheter devices are commonly used for various infusion therapies. For example, IV catheter devices may be used to infuse fluids such as saline, various medications, and total parenteral nutrition into a patient. IV catheter devices may also be used to collect blood from a patient.

[0003] A common type of IV catheter device includes an "over-the-needle" catheter. As its name suggests, an over-the-needle catheter can be mounted over a needle having a sharp distal tip. The catheter and the needle can be assembled such that the distal tip of the 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 needle are generally inserted at a shallow angle through the skin and into the patient's vasculature. Once the catheter is positioned within the vasculature, the catheter may become occluded, such as when a thrombus forms around the distal opening of the catheter, or when the distal opening is positioned against the vessel wall.

[0004] If an IV catheter device is not properly secured within the patient's vascular system, it can become blocked. When an IV catheter device becomes blocked, it may no longer be possible to use it for fluid infusion or blood sampling. In such cases, the IV catheter device may need to be replaced. However, replacing an IV catheter device is burdensome for the patient and increases costs. To address these issues, several devices have been developed that can be inserted through the catheter of an IV catheter device left in a body organ to remove the blockage. For example, some devices utilize a rigid tube that can be inserted through the catheter and reach distally beyond the distal opening of the catheter. With the rigid tube inserted in this manner, such a device can obtain a blood sample through the rigid tube even if the catheter is blocked. In other words, the rigid tube is used to physically penetrate any blockage that may form at or around the distal opening of the catheter, creating a separate fluid pathway from the catheter for blood sampling. When the rigid tube is used in this manner, it can become blocked as it advances through the blockage or thrombus.

[0005] The subject matter claimed herein is not limited to embodiments that resolve any disadvantage or embodiments that operate only in the environments described above. Rather, this background art is provided solely to illustrate one exemplary area of ​​technology in which some of the embodiments described herein may be carried out. [Overview of the project] [Problems that the invention aims to solve]

[0006] This disclosure relates to intravenous catheter devices having a guidewire for actively repositioning the catheter tip. The guidewire assembly may be configured to allow a clinician to actively reposition the catheter tip by moving the proximal end of a segment of the guidewire. By repositioning the catheter tip, the guidewire assembly can facilitate the collection of blood samples or the injection of fluids through the catheter, even if the catheter tip is blocked. [Means for solving the problem]

[0007] In some embodiments, the guidewire assembly may include a guidewire housing, a guidewire actuator configured to slide within the guidewire housing, and a guidewire having a first segment and a second segment. The guidewire actuator may be coupled to the proximal end of the first segment and the proximal end of the second segment so that the guidewire slides when the guidewire actuator slides within the guidewire housing. The guidewire actuator may be further configured to cause relative movement between the proximal end of the first segment and the proximal end of the second segment, thereby causing the distal end of the guidewire to be repositioned.

[0008] In some embodiments, a single wire may form the first and second segments, or multiple wires may form the first and second segments. In some embodiments, the guidewire actuator may include a first tab coupled to the proximal end of the first segment. The first tab may move relative to the body of the guidewire actuator to cause relative movement between the proximal end of the first segment and the proximal end of the second segment. In some embodiments, the first tab may move relative to the body by sliding along the body. In some embodiments, the guidewire actuator may include a second tab coupled to the proximal end of the second segment. The second tab may move relative to the body of the guidewire actuator to cause relative movement between the proximal end of the first segment and the proximal end of the second segment. In some embodiments, the first and second tabs may move relative to the body by sliding along the body.

[0009] In some embodiments, the guidewire actuator may include a body, and the proximal ends of the first segment and the proximal ends of the second segment may be coupled to the body. The body may rotate to cause relative movement between the proximal ends of the first segment and the proximal ends of the second segment. In some embodiments, the first segment and the second segment may be wrapped around the body in opposite directions.

[0010] In some embodiments, the guidewire may include a ring that maintains the spacing between the first and second segments. In some embodiments, the guidewire may include a bent portion spaced apart from the distal end. In some embodiments, the guidewire may include a dome-shaped distal end.

[0011] In some embodiments, the first segment may be a core wire, and the second segment may be a coil extending around the core wire. In some embodiments, the proximal end of the first segment may be coupled to a tab of a guidewire actuator, and the guidewire actuator may further include a spring that biases the tab in the proximal direction.

[0012] In some embodiments, the intravenous catheter device may include a catheter adapter through which a catheter extends, and a guidewire assembly coupled to the catheter adapter. The guidewire assembly may include a guidewire housing, a guidewire actuator configured to slide within the guidewire housing, and a guidewire having a first segment and a second segment. The guidewire actuator may be coupled to the proximal end of the first segment and the proximal end of the second segment so as to allow the guidewire to slide as the guidewire actuator slides within the guidewire housing, thereby positioning the distal end of the guidewire near or adjacent to the distal end of the catheter. The guidewire actuator may be further configured to cause relative movement between the proximal end of the first segment and the proximal end of the second segment, thereby causing the distal end of the guidewire to be repositioned and thus repositioning the distal end of the catheter. In some embodiments, the guidewire actuator may rotate relative to the guidewire housing, and such rotation may cause the distal end of the catheter to be repositioned. In some embodiments, the guidewire assembly may form a fluid pathway for collecting a blood sample through the catheter.

[0013] In some embodiments, the guidewire actuator may include a first tab coupled to the proximal end of the first segment. The first tab may move relative to the body of the guidewire actuator to cause a relative movement between the proximal end of the first segment and the proximal end of the second segment.

[0014] In some embodiments, the guidewire actuator may include a second tab coupled to the proximal end of the second segment. The second tab may move relative to the body of the guidewire actuator to cause a relative movement between the proximal end of the first segment and the proximal end of the second segment.

[0015] In some embodiments, the guidewire actuator may include a body, and the proximal ends of the first segment and the proximal ends of the second segment may be coupled to the body. The body may rotate to cause relative movement between the proximal ends of the first segment and the proximal ends of the second segment.

[0016] In some embodiments, a method for repositioning the distal end of an intravenous catheter may include advancing a guidewire toward the distal end of the catheter while the catheter is positioned intravenously. The guidewire may include a first segment and a second segment. In some embodiments, the method may also include moving the proximal end of the first segment relative to the proximal end of the second segment while the distal end of the guidewire is positioned toward or near the distal end of the catheter, thereby causing the distal end of the guidewire to be repositioned. Repositioning the distal end of the guidewire may also include repositioning the distal end of the catheter. In some embodiments, moving the proximal end of the first segment relative to the proximal end of the second segment may include moving the proximal end of the first segment distally or proximal; moving the proximal end of the second segment distally or proximal; moving the proximal ends of the first segment and the proximal ends of the second segment in opposite proximal and distal directions, respectively; or rotating the proximal ends of the first segment and the proximal ends of the second segment around an axis.

[0017] It should be understood that both the general description above and the detailed description below are illustrative and for illustrative purposes only, and do not limit the invention as described in the claims. It should be understood that various embodiments are not limited to the arrangements and means shown in the drawings. It should also be understood that embodiments can be combined or other embodiments can be utilized, and structural modifications can be made without departing from the scope of the various embodiments of the invention, unless otherwise stated in the claims. Therefore, the detailed description below should not be interpreted as restrictive. [Brief explanation of the drawing]

[0018] Exemplary embodiments are described and explained in more specific and detail with reference to the accompanying drawings.

[0019] Figure 1 shows an example of an IV catheter device including a guidewire assembly configured according to the present invention.

[0020] Figure 2A is a cross-sectional view of a guide wire assembly configured according to the present invention.

[0021] Figure 2B is a cross-sectional view of a guidewire assembly configured according to the present invention.

[0022] Figure 2C is a cross-sectional view of a modified example of the guidewire assembly shown in Figure 2A.

[0023] Figure 3A is a cross-sectional view of the guidewire assembly in a first position, illustrating how the catheter tip can be actively repositioned according to the present invention.

[0024] Figure 3B is a cross-sectional view of the guidewire assembly in a second position, illustrating how the catheter tip can be actively repositioned according to the present invention.

[0025] FIG. 3C is a cross-sectional view of the guidewire assembly in a third position, showing how the catheter tip can be actively repositioned in accordance with the present invention.

[0026] FIG. 4A is a schematic view of the guidewire assembly in a first position according to the present invention.

[0027] FIG. 4B is a schematic view of the guidewire assembly in a second position according to the present invention.

[0028] FIG. 4C is a schematic view of the guidewire assembly in a third position according to the present invention.

[0029] FIG. 4D is a partial perspective view of the guidewire assembly according to the present invention.

[0030] FIG. 5A is a schematic side view of the guidewire according to the present invention.

[0031] FIG. 5B is a schematic side view of the guidewire according to the present invention.

[0032] FIG. 5C is a schematic side view of the guidewire according to the present invention.

[0033] FIG. 5D is a schematic side view of the guidewire according to the present invention.

[0034] FIG. 5E is a schematic side view of the guidewire according to the present invention.

[0035] FIG. 6A is a partial front view of an IV catheter device including the guidewire assembly according to the present invention.

[0036] FIG. 6B is a partial front view of an IV catheter device including the guidewire assembly according to the present invention.

[0037] FIG. 7A is a partial side view of a guidewire assembly configured in accordance with the present invention.

[0038] Figure 7B is a partial side view of a guide wire assembly configured according to the present invention.

[0039] Figure 7C is a partial side view of a guide wire assembly configured according to the present invention.

[0040] Figure 7D is a partial side view of a guide wire assembly configured according to the present invention.

[0041] Figure 8A is a partial side view of a guide wire assembly configured according to the present invention.

[0042] Figure 8B is a partial side view of a guide wire assembly configured according to the present invention.

[0043] Figure 9A is a partial front view of an IV catheter device including a guidewire assembly configured according to the present invention.

[0044] Figure 9B is a partial front view of an IV catheter device including a guidewire assembly configured according to the present invention. [Modes for carrying out the invention]

[0045] An IV catheter device that can be used in some embodiments may include a catheter adapter to which the catheter extends distally, and one or more ports or one or more connectors for attaching other devices to the catheter adapter. Such devices may be attached to the catheter adapter before, during, or after insertion of the catheter into the patient's vascular system, and may include a needle assembly, a blood collection set, an infusion assembly, any embodiment of the guidewire assembly described herein. In some embodiments, the guidewire assembly may be integrated with the IV catheter device, as opposed to being selectively connected to the IV catheter device. Accordingly, embodiments of the present disclosure should not be limited to any particular configuration of an IV catheter device or to specific examples of IV catheter devices used herein.

[0046] Figure 1 provides an example of an IV catheter device 100 configured according to several embodiments of the present disclosure. The IV catheter device 100 includes a catheter adapter 110 from which a catheter 111 extends distally. Although not shown, a needle assembly is typically attachable to the catheter adapter 110 and is used to insert the catheter 111 into the patient's vascular system, after which it can be removed from the catheter adapter 110. The IV catheter device 100 also includes an adapter 114 connected to a side port 110a of the catheter adapter 110.

[0047] The IV catheter device 100 also includes a guidewire assembly 200 having a guidewire housing 210, the guidewire housing 210 capable of housing the guidewire 230 at least when the guidewire 230 is not extending through the catheter 111. A connector 220 may be formed at the distal end of the guidewire housing 210, and the connector 220 can function to connect the guidewire assembly 200 to the IV catheter device 100 (for example, via port 114a of the adapter 114 shown in Figure 1). However, in other embodiments, the guidewire housing 210 may be integrated with the adapter 114 or another component of the catheter adapter 110. In other words, how the guidewire assembly is connected to the catheter adapter is not critical in the embodiments of this disclosure.

[0048] The guidewire assembly 200 may also include a guidewire actuator 240, which extends outward from the guidewire housing 210 and slides along a channel 211 formed in the guidewire housing 210. The guidewire actuator 240 allows a clinician to move the guidewire 230 relative to the catheter 111 by sliding the guidewire actuator 240 along the length of the guidewire housing 210 within the channel 211. As will be described in detail below, a guidewire assembly configured according to embodiments of the present disclosure may include a guidewire that can be actively repositioned via the guidewire actuator, thereby repositioning the tip of the catheter through which the guidewire extends. In some embodiments, such as the embodiment shown in Figure 1, the guidewire actuator 240 may include a body 241 and one or more tabs 242, by which the guidewire 230 can be actively repositioned. Figure 1 shows the guidewire actuator 240 at its most distal position, and therefore the distal end of the guidewire 230 is positioned at, near, or beyond the distal opening of the catheter 111.

[0049] The IV catheter device 100 also includes an extension tube 115 and an adapter 116, where one end of the extension tube 115 is coupled to port 114b of the adapter 114, and the adapter 116 is located at the opposite end of the extension tube 115. A blood collection set 300 may be coupled to or integrated with the adapter 116. A clamp 115a may be located around the extension tube 115 to selectively block the flow of fluid through the extension tube. In contrast to what is shown in Figure 1, in some embodiments the extension tube 115 and the blood collection set 300 may be coupled to the proximal end of a guidewire assembly 200, thereby allowing blood samples to be collected via the guidewire assembly 200 or fluid to be injected via the guidewire assembly 200.

[0050] A guidewire assembly configured according to embodiments of this disclosure can be used to move the catheter tip, thereby removing any blockages that may form around the distal opening of the catheter, and / or to reposition the catheter tip if the distal opening of the catheter tip may be blocked by a blood vessel wall or other vascular structure. For example, after the catheter 111 has been inserted into the patient's vascular system, but before the guidewire 230 can be advanced and / or repositioned within the catheter 111, a thrombus may form around or near the opening of the catheter 111, preventing blood or fluid from flowing through the catheter 111. In such a case, the guidewire actuator 240 can be moved to its most distal position, allowing the guidewire 230 to be advanced near the distal end of the catheter 111, to the distal end of the catheter 111, or beyond the distal end of the catheter 111 (if it is not already present at this distal position). Next, the tab 242 is manipulated to move the guidewire 230, thereby moving the catheter 111 to remove any blockages or obstructions and / or to reposition the opening of the catheter 111 away from the source of the thrombus or other blockage (e.g., vein wall, valve, blood clot, etc.).

[0051] Figures 2A and 2B are cross-sectional views of exemplary embodiments of the guidewire assembly 200. As shown, the guidewire assembly 200 may include a guidewire housing 210, with one or more channels 211 extending along the guidewire housing 210 to allow the guidewire actuator 240 to slide distally and proximal along the guidewire housing 210. In the illustrated embodiment, the guidewire actuator 240 includes a body 241 configured to house a first tab 242a and a second tab 242b in a slidable arrangement. The guidewire 230 may include a first segment 231 and a second segment 232, the first segment 231 and the second segment 232 having distal ends connected to each other to form a distal end 233 of the guidewire 230. The proximal end 231a of the first segment 231 may be coupled to the first tab 242a, and the proximal end 232a of the second segment 232 may be coupled to the second tab 242b. Therefore, when the first tab 242a and the second tab 242b move relative to each other, the first segment 231 and the second segment 232 also move relative to each other. More specifically, since the distal ends of the first segment 231 and the second segment 232 are connected at the distal end 233, relative movement between the proximal ends 231a and 232a causes the distal end 233 to be repositioned. When the distal end 233 is positioned within the distal opening of the catheter 111, at the distal opening of the catheter 111, or near the distal opening of the catheter 111, the repositioning of the distal end 233 causes the catheter 111 to move. In some embodiments, the guide wire 230 may extend through a fluid seal 214 positioned within the guide wire housing 240.

[0052] Figures 3A to 3C illustrate how the guidewire actuator 240 is operated to reposition the distal end 233, thereby repositioning the tip of the catheter 111. In Figure 3A, the first tab 242a and the second tab 242b are aligned and positioned. Thus, assuming that the first and second segments 231 and 232 are substantially the same length, the guidewire 230 can be substantially straight. In contrast, in Figure 3B, the first tab 242a is moved to the right and the second tab 242b is moved to the left. As a result, the first segment 231 is moved to the right relative to the second segment 232, thereby causing the guidewire 230 to bend upward at the distal end 233. Similarly, in Figure 3C, the first tab 242a is moved to the left and the second tab 242b is moved to the right. As a result, the first segment 231 is moved to the left relative to the second segment 232, thereby causing the guidewire 230 to bend downward at the distal end 233. The degree of this bending may depend on the extent to which the first and second tabs 242a and 242b are moved relative to each other. In particular, this active repositioning of the distal end 233 may be caused by moving only one of the first tab 242a or the second tab 242b (i.e., a clinician may reposition the tip of the catheter 111 by causing a relative movement between the first tab 242a and the second tab 242b). Also, in some embodiments, the guidewire actuator 240 may be configured to rotate (e.g., to the right or to the left) to cause this bending to occur along different planes.

[0053] Figure 2C shows a modified version of the guidewire assembly 200 shown in Figures 2A and 2B. In this modification, the guidewire actuator 240 includes a single tab 242 to which the proximal end 231a of the first segment 231 is coupled. The proximal end 232a of the second segment 232 is fixed to the body 241. Thus, Figure 2C represents an embodiment in which the proximal end of only one of the first and second segments 231 and 232 moves, causing the distal end 233 to be repositioned.

[0054] In some embodiments, the first segment 231 and the second segment 232 may be part of the same wire. For example, the distal end 233 may be a bend in a single wire. In other embodiments, the first segment 231 and the second segment 232 may be multiple different wires joined to each other at the distal end 233 or elsewhere. One or more wires forming the guide wire 230 can be made from a variety of materials, including, for example, stainless steel, nickel-titanium alloy, or polymers, such as nylon, polytetrafluoroethylene (PTFE), and polyetherimide. In some embodiments, one or more wires may be formed from a coated core material, such as a metal core with a polymer coating. In some embodiments, the first and second segments 231 and 232 may be substantially linear. In some embodiments, the first and second segments 231 and 232 may include a bend near the distal end 233. In some embodiments, the first segment 231 may be a core wire, and the second segment 232 may be a coil wound around the first segment 231. In some embodiments, the distal end 233 may be dome-shaped or include a dome shape. Thus, the guidewire 230 can take various forms and include various features in embodiments of this disclosure.

[0055] Figures 4A to 4D provide another example of a guidewire assembly 200 configured according to one or more embodiments. In this example, the guidewire actuator 240 includes a round body 241 and a tab 242 which can be used to rotate the body 241. The first and second segments 231 and 232 extend in opposite directions around the body 241, with their proximal ends 231a and 232a fixed to the body 241. As the body 241 rotates, the first and second segments 231 and 232 move in opposite directions relative to each other, thereby causing the distal end 233 to be repositioned. Figure 3D shows that, in addition to this rotation, the guidewire assembly 240 can slide within the channel 211 to position the distal end 233 near the tip of the catheter 111, at the tip of the catheter 111, or beyond the tip of the catheter 111.

[0056] Figures 5A to 5E provide examples of how the guide wire 230 may be configured in one or more embodiments. In Figure 5A, the first segment 231 and the second segment 232 are formed from a single wire bent at the distal end 233. In Figure 5B, the first segment 231 and the second segment 232 are also formed from a single wire bent at the distal end 233, but the guide wire 230 also includes a ring 500 (or other connecting element). The ring 500 may be attached to the second segment 232 or wrapped around the first segment 231. For example, the ring 500 can be fixed to a fixed point of the second segment 232 using a weld 500a or other joining technique. The ring 500 can function to maintain the proximity of the first segment 231 to the second segment 232 when the distal end 233 is repositioned. For example, if the first segment 231 is pulled to the right relative to the second segment 232, the ring 500 may function to create a pivot point from which the distal portions of the first and second segments 231 and 232 can pivot upward. In contrast, without the ring 500, the first segment 231 tends to arch away from the second segment 232, thereby minimizing the movement of the distal end 233.

[0057] Figure 5C provides an example in which a bend 501 is formed near the distal end 233 of the first and second segments 231 and 232. The bend 501 may be formed independently of the operation of the guidewire actuator 240. In other words, the guidewire 233 may have the bend 501 formed as its default orientation. Figure 5D provides an example in which a dome 502 or other rounded shape is formed at the distal end 233. The dome 502 can minimize the possibility of damage to the vascular system when the guidewire 230 is extended from the catheter 111. Figure 5E provides an example in which the first segment 231 and the second segment 232 are formed from two separate wires joined together. In the illustrated example, a weld 503 or other joining technique or structure is formed at the distal end 233. However, multiple wires may be joined together at any other location to form the guidewire 230. The examples provided in Figures 5A to 5E should not be considered mutually exclusive.

[0058] Figures 6A and 6B show another exemplary configuration of the guidewire assembly 200 of the IV catheter device 100. In this exemplary configuration, the guidewire actuator 240 includes a first tab 242a and a second tab 242b, which are slidably coupled to opposite sides of the body 241. In addition, the body 241 (or at least the first and second tabs 242a and 242b) is configured to rotate relative to the guidewire housing 210. For example, in Figure 6B, the guidewire actuator 240 is rotated 90 degrees relative to its position in Figure 6A, and this rotation causes the guidewire 230 to reposition the tip of the catheter 111 even without the sliding movement of the first and second tabs 242a and 242b.

[0059] Figures 6A and 6B also show embodiments in which the guidewire assembly 200 is coupled to the inline port 110b of the catheter adapter 110. The septum 610 may be positioned within the inline port 110b, in which case the guidewire 230 may pass through the septum 610.

[0060] Figures 7A–7D show, individually, another exemplary configuration of the guidewire assembly 200. Compared to Figure 1, the guidewire assembly 200 in these figures includes an extension tube 700 extending from the proximal end of the guidewire housing 210. Although not shown, a blood collection set 300 or another fluid capture or fluid injection set is coupled to the extension tube 700, thereby enabling the collection of a blood sample or the injection of a fluid via the guidewire assembly 200. In other words, the guidewire housing 210 may form a fluid pathway. Figures 7A–7D also show how the guidewire 230 can be operated by sliding the guidewire actuator 240 along the guidewire housing 210, sliding the tab 242 relative to the body 241, and rotating the guidewire actuator 240 relative to the guidewire housing 210.

[0061] Figures 8A and 8B show another exemplary configuration of the guidewire assembly 200. In this exemplary configuration, the first segment 231 is in the form of a core wire, and the second segment 232 is in the form of a coil extending around the core wire. The proximal end 231a of the first segment 231 may be attached to the tab 242, and the proximal end 232a of the second segment 232 may be fixed to the body 241. In such embodiments, the guidewire actuator 240 may include a spring 800 that biases the tab 242 to a proximal position relative to the body 241. In some embodiments, the guidewire 230 can be configured to be substantially linear when the tab 242 is in this proximal position. In contrast, when the tab 242 is slid distally, the guidewire 230 can be repositioned as shown in Figure 8B. Alternatively, the guidewire 230 may be curved when the tab 242 is in a proximal position, and straightened when the tab 242 moves to a distal position. In either case, distal movement of the tab 242 relative to the main housing 241 can cause the distal end 233 of the guidewire 230 to be repositioned. The spring 800 may cause the tab 242 to return to the proximal position without external force. It should be noted that the guidewire formed by the core wire and coil can be used in any of the guidewire assemblies described herein and is not limited to the embodiments shown in Figures 8A and 8B. In particular, the guidewire formed by the core wire and coil does not need to be used with the spring 800.

[0062] In the modified embodiments shown in Figures 8A and 8B, the spring 800 can be removed, and the proximal end 232a of the second segment 232 can be extended to the tab 242. In other words, the coil formed by the second segment 232 is coupled to the tab 242 and can therefore move with the tab 242. In such embodiments, the body 241 can be configured to apply a compressive force to the second segment 232 (or otherwise hold the second segment 232) as it passes through the body 241, thereby causing the portion of the second segment 232 that is inside the body 241 to be compressed as the tab 242 moves distally. This compression of the portion of the second segment 232 can cause the tab 242 to abruptly return to the proximal position when the distal force is no longer applied to the tab 242. Thus, in such embodiments, the portion of the second segment 232 that is inside the body 241 functions similarly to the spring 800. In these embodiments, the repositioning of the guidewire 230 can be performed substantially in the same manner as shown in Figures 8A and 8B, considering that the main body 241 fixes the second segment 232 in place while the first segment 231 moves distally.

[0063] In another similar modification, the proximal end 232a of the second segment 232 can also extend to the tab 242, and the body 241 can also be configured to apply a compressive force to the second segment 232 (or otherwise hold the second segment 232) at the point where the second segment 232 passes through the body 241. However, in contrast to the above modification, the tab 242 can be configured to slide proximal to reposition the guidewire 230. In other words, a proximal force can be applied to the tab 242 to pull the distal end 233 of the guidewire 230 proximal. Due to the compressive force on the second segment 232, the portion of the second segment 232 located between the tab 242 and the point where the compressive force is applied stretches as the tab 242 slides proximal. Then, when the proximal force is no longer applied to the tab 242, this portion of the second segment 232 returns to its unstretched position. In short, in these modifications, the midpoint of the coil-shaped second segment 232 can be held in place even as the first segment 231 moves distally or proximal, thereby causing the distal end 233 to move off-axis.

[0064] Figures 9A and 9B show, respectively, another exemplary configuration of the guidewire assembly 200. In each of these examples, the guidewire assembly 200 is integrated with the catheter adapter 110. In other words, a portion of the catheter adapter 110 is used in place of the guidewire housing 210. In Figure 9A, the first tab 242a and the second tab 242b are integrated with the inline port 110b, but otherwise it functions as described above. In Figure 9B, the first tab 242a and the second tab 242b are integrated with the side port 110a, but otherwise it functions as described above. Thus, embodiments of the present disclosure include guidewire assemblies that are separate from and removable from the catheter adapter, guidewire assemblies that are separate from the catheter adapter but not removable, guidewire assemblies that are integrated with the catheter adapter, and so on.

[0065] In summary, a guidewire assembly configured according to embodiments of the present disclosure may include a two-segment guidewire having a distal end that can be moved off-axially by relative movement between the proximal ends of the two segments. Movement of the distal end of the guidewire allows for active repositioning of the catheter tip while the catheter tip is positioned in a vein. Repositioning may be performed to remove any obstruction from the catheter opening, to move the catheter opening away from the vascular wall or other obstruction, or to facilitate blood sampling or fluid infusion through the catheter. In particular, the guidewire assembly according to embodiments of the present disclosure facilitates this repositioning of the catheter tip without moving or adjusting the catheter adapter or changing the insertion depth of the catheter itself. In short, embodiments of the present disclosure provide clinicians with targeted control over the position of the catheter tip.

[0066] All examples and conditional statements listed herein are intended for educational purposes to help the reader understand the concepts to which the inventors have contributed to advance the invention and the art, and should be construed as not being limited to such specifically listed examples and conditions. While embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made herein without departing from the spirit and scope of the invention.

Claims

1. A guidewire assembly for advancing and retracting a guidewire into and out of a catheter, and for repositioning the distal end of the catheter, Guide wire housing and A connector formed at the distal end of the guidewire housing and configured to connect to an IV catheter device including the catheter, A guide wire actuator configured to slide within the guide wire housing, A guide wire having a first segment and a second segment, Equipped with, The guidewire actuator is coupled to the proximal end of the first segment and the proximal end of the second segment such that the guidewire slides when the guidewire actuator slides within the guidewire housing, and the guidewire actuator is further configured to advance the guidewire through the IV catheter device to the distal end of the catheter, causing a relative movement between the proximal end of the first segment and the proximal end of the second segment, thereby causing the distal end of the guidewire to be repositioned. Guide wire assembly.

2. The guide wire assembly according to claim 1, wherein a single wire forms the first segment and the second segment.

3. The guide wire assembly according to claim 1, wherein a plurality of wires form the first segment and the second segment.

4. The guidewire assembly according to claim 1, wherein the guidewire actuator includes a first tab coupled to the proximal end of the first segment, the first tab moving relative to the body of the guidewire actuator to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

5. The guide wire assembly according to claim 4, wherein the first tab moves relative to the body by sliding along the body.

6. The guidewire assembly according to claim 4, wherein the guidewire actuator includes a second tab coupled to the proximal end of the second segment, the second tab moving relative to the body of the guidewire actuator to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

7. The guide wire assembly according to claim 6, wherein the first tab and the second tab move relative to the body by sliding along the body.

8. The guidewire assembly according to claim 1, wherein the guidewire actuator includes a body, the proximal end of the first segment and the proximal end of the second segment are coupled to the body, and the body rotates to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

9. The guide wire assembly according to claim 8, wherein the first segment and the second segment are wound in opposite directions relative to the main body.

10. The aforementioned guide wire is A ring that maintains the spacing between the first and second segments, A bent portion spaced apart from the distal end, or Dome-shaped distal end The guide wire assembly according to claim 1, further comprising one or more of the following.

11. The guide wire assembly according to claim 1, wherein the first segment is a core wire, and the second segment is a coil extending around the core wire.

12. The guidewire assembly according to claim 11, wherein the proximal end of the first segment is coupled to a tab of the guidewire actuator, and the guidewire actuator further includes a spring that biases the tab in the proximal direction.

13. Intravenous catheter device, A catheter adapter having a distal end from which a catheter extends and equipped with a port, A guidewire assembly connected directly or via an additional adapter to the port of the catheter adapter, Equipped with, The aforementioned guide wire assembly is Guide wire housing and A guide wire actuator configured to slide within the guide wire housing, A guide wire having a first segment and a second segment, Equipped with, The guidewire actuator is coupled to the proximal end of the first segment and the proximal end of the second segment such that the guidewire slides when the guidewire actuator slides within the guidewire housing, thereby allowing the distal end of the guidewire to advance through the catheter adapter and the catheter and be positioned at or near the distal end of the catheter; the guidewire actuator is further configured to cause relative movement between the proximal end of the first segment and the proximal end of the second segment, thereby causing the distal end of the guidewire to be repositioned, thereby repositioning the distal end of the catheter. Intravenous catheter device.

14. The intravenous catheter device according to claim 13, wherein the guidewire actuator includes a first tab coupled to the proximal end of the first segment, the first tab moving relative to the body of the guidewire actuator to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

15. The intravenous catheter device according to claim 14, wherein the guidewire actuator includes a second tab coupled to the proximal end of the second segment, the second tab moving relative to the body of the guidewire actuator to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

16. The intravenous catheter device according to claim 13, wherein the guidewire actuator includes a body, the proximal end of the first segment and the proximal end of the second segment are coupled to the body, and the body rotates to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

17. The intravenous catheter device according to claim 13, wherein the guidewire actuator rotates relative to the guidewire housing, and the rotation also causes the distal end of the catheter to be repositioned.

18. The intravenous catheter device according to claim 13, wherein the guidewire assembly forms a fluid pathway for collecting a blood sample through the catheter.

Citation Information

Patent Citations

  • steerable wire guide with articulation

    JP2009516571A

  • Bending and stretching device, and bending and stretching method

    JP2015192845A

  • Vascular access instrument having a fluid permeable structure, and related devices and methods

    US20200316346A1

  • Intraluminal device with looped core wire

    US20210128877A1

  • Steerable guide wire for delivering an implantable medical device

    US7449002B1