Syringe with injectable rigid wire for the insertion of intravascular catheters

Abstract

This invention relates to a plastic catheter (2) which can be introduced intravascularly by means of a syringe with a permanently attached guide wire (8). This plastic catheter (2) has a Luer-Lock connection and remains in the vessel (or other target structure) after completion of the procedure. After inserting the syringe into a blood vessel, the wire (8) attached to the syringe is slowly advanced by slowly pressing the plunger of the syringe with the thumb. This injects the liquid and wire into the vessel. After the wire has been advanced into the vessel, the catheter (2) is inserted along the wire. The wire is withdrawn. The catheter remains in the vessel.

Description

[0001] Field of application of the invention: Medicine, in particular anesthesiology and intensive care medicine.

[0002] Solution to an underlying problem: 1. The common Seldinger technique for inserting catheters into body vessels can be performed with one hand instead of two thanks to this invention. Blood loss is also significantly reduced. With the well-known Seldinger technique, a metal cannula is first inserted into the vessel, and then a guidewire is inserted through it. Between these two steps, the metal cannula can change its intravascular position, and blood often flows out in the meantime. 2. Insertion of venous catheters can be made safer and more successful. Materials can be saved. Multiple attempts on the same patient (under sterile conditions) can be performed with a single syringe, instead of using a new venous catheter (Flexule) for each attempt.

[0003] This technique involves an intravascular catheter (plastic cannula) that can be inserted intravascularly through a syringe with a permanently attached guidewire (8). This syringe and catheter can (among other things): 1) can be used as a new method for inserting venous catheters (flexules), especially for deep veins and central veins. The catheter can be directly connected to medication lines. 2) Catheters can be calibrated arterial catheters that can be connected directly.

[0004] The catheter (2) is a plastic catheter with a Luer-Lock connector, which should remain in the vessel (or other target structure) after completion of the procedure.

[0005] The attached wire (8) is firmly connected to the rubber stopper of the syringe (3). The plunger (5), rubber stopper, and wire (8) are firmly connected together; they all move as a single unit when the plunger (5) moves into or out of the cylindrical cavity (9).

[0006] The stopper (4) prevents the distal free end of the wire from floating into the cylindrical cavity (9) when the plunger (5) is retracted (in the case of filling the needle with saline solution or draining blood when puncturing a blood vessel). Thus, the rubber plug (3) is stopped by this stopper (4) and can no longer be pulled back.

[0007] As a variant: The stopper (4) could be a constriction of the cylindrical cavity (9) so that the rubber plug (3) and the guide wire (8) cannot be retracted any further.

[0008] A mark (line or color) should be drawn on the needle tube or cylindrical cavity (9) parallel to the rubber plug (3), at the level where the wire is located directly at the cannula tip (1). This mark indicates whether the wire is distal to the cannula tip (1) or within the metal cannula (6). We could call this position of the wire the zero point.

[0009] The introducer (plastic catheter) (2) is a plastic catheter with a Luer-Lock connector that should remain in the vessel (or other target structure) after completion of the procedure.

[0010] The needle should be filled with fluid and the wire retracted to position zero or greater. The needle is purged of air and bubbles before use on the patient.

[0011] It is not always necessary to advance the entire length of the wire. In small vessels, it may be sufficient to advance only 2-3 mm of the wire to insert the catheter (2) along the wire.

[0012] A structure could be added to the needle cone (7) of the syringe to hold the wire in the center of the structure.

[0013] A longer guidewire could be inserted through the catheter (2) (after insertion), for example, for a central venous catheter (CVC). (Here, the catheter serves as a sheath.)

[0014] One possible wire variation is a wire with a flexible spiral tip to navigate the tortuous vascular anatomy and thus enable atraumatic puncture. This wire variant has a straight position while the wire is still in the metal cannula (6). Coiling only occurs at the tip of the wire when it leaves the cannula tip (1).

[0015] A second option is that the tip of the wire can be made thinner than the rest of the wire, so that the risk of perforation of the blood vessel can be reduced. Procedure for use:

[0016] Prepare the syringe by filling it with NaCl. Remove any air and bubbles. Pull the wire back to the zero point or even further.

[0017] Insert the needle under negative pressure (aspiration) or under ultrasound guidance until blood comes out of the needle or until the user is sure that the cannula tip (1) is centered in the vessel (under ultrasound, for example). The wire is then slowly advanced by slowly pressing the plunger (5) with the thumb. This injects fluid (which is already in the needle) and with it the wire is inserted into the vessel. Injected fluid could help to dilate the blood vessel and thus make it easier to advance the wire. If swelling or resistance is felt when advancing the wire, the cannula tip (1) is probably outside the vessel; the vessel should be searched for again. Users do not need to use a new syringe for each attempt. They can simply flush the system with NaCl, for example, and search for the vessel again.This is a big advantage compared to conventional IV cannulas. After the wire has been advanced into the vessel, the metal cannula (6) with the catheter (2) is advanced a few millimeters. Now, only the catheter (2) is inserted along the wire. The wire is withdrawn by pulling back the plunger (5). The catheter (2) remains in the vessel, and the rest of the syringe is withdrawn.

[0018] Use of this technology: (among others) 1. As an intravenous access or intravenous cannula. 2. As an arterial line: A calibrated arterial line should be used as the catheter. An arterial catheter can also be inserted through the catheter. 3. As a sheath for other vascular lines and wires, for example for inserting the wire of a central venous line. 4. As an insertion aid for pain catheters for local anesthesia. 5. Insertion aid for tracheostomy tubes. Advantages of this technology: 1. It can be used for more than one attempt on the same patient under sterile conditions (cost-effective): Conventional IV access needles usually have to be discarded after a failed puncture. This syringe can be rinsed with saline or another clear medical fluid, allowing it to be reused on the same patient under sterile conditions. 2. This is the first wire-based catheter syringe that allows injection and drainage of fluid or blood, and the first system that injects fluid with a guidewire in one step. 3. One-handed technique: This catheter syringe could be held with one hand, so that the user can hold the ultrasound probe with the other hand until he sees the wire inside the vessel. 4. Injecting 2-3 ml of fluid before the wire enters the vessel may facilitate wire insertion and provide an indication of whether the needle is still outside the vessel (swelling). 5. With this catheter syringe, the insertion of arterial catheters and central venous catheters can be almost bleeding-free, since the wire is not injected using the Seldinger technique but rather through a syringe. 6. This technique avoids pushing the venous catheter “para” even though the user has seen blood when puncturing the vessel. 7. Medical personnel are familiar with the handling and movements of conventional syringes; this wire syringe is no different from the handling of a regular syringe.

[0019] Although the invention is described with respect to the insertion of an intravenous catheter, the devices and methods described herein could be readily adapted for the insertion of any catheter or similar device into a vein, artery, or other internal body structure.

[0020] State-of-the-art technology: For years, there have been successive attempts to improve and redesign the technique of inserting an intravenous catheter. Some patented techniques and designs include: 1. Device for introducing an intravenous catheter Inventors Amir BelsonGregory W. HALLScott A. DanielRobert Brommer Patent No.: US9162037B2 Here, blood cannot be reused after a flush, and there's no way to inject or drain fluids or blood. It's a single-attempt device that must be discarded after a failed attempt. It's not as easy to use as the wire syringe described here. 2. Intravenous catheter device with a catheter telescoped on the outside of the puncture cannula, US3592192A, inventor Andrew Harautuneian: Same weaknesses as 1. 3. US4655750A: Closed system catheter with guidewire, Inventor Vincent L. Vaillancourt: The guidewire is manipulated forward by grasping the wire through a pocket-like sheath and advancing it forward, two-handed technique, one attempt and then discarded. 4. US9675784B2: Devices for introducing intravenous catheters and for blood sampling and method of use, inventor Amir Belson The entire design is different. Once backflow occurs, it can't be cleaned and reused with the same efficiency. 5. Device and method for advancing a guide wire US10617846B2: Inventor Jessica A. WarringAmir BelsonWinfield S. Fisher Similar to its predecessor with its weak points. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 9162037B2

[0020] US 3592192A

[0020] US 4655750A

[0020] US 9675784B2

[0020] US 10617846B2

[0020]

Claims

[1] that a syringe with a permanently attached guide wire is used to guide this catheter(2) intravascularly. The catheter (2) is a plastic catheter with a Luer-Lock connector, which should remain in the vessel (or other target structure) after completion of the procedure. [2] The attached wire (8) is firmly connected to the rubber stopper of the syringe (3). The plunger (5), rubber stopper, and the wire (8) are firmly connected together; they all move as a unit when the plunger (5) moves into or out of the cylindrical cavity (9). [3] The stopper (4) prevents the distal free end of the wire from floating into the cylindrical cavity (9) when the plunger (5) is retracted (in the case of filling the syringe with saline solution or draining blood when puncturing a blood vessel). Thus, the rubber stopper (3) is stopped by this stopper (4) and can no longer be pulled back. [4] As a variant: The stopper (4) could be a constriction of the needle tube (9) so that the rubber stopper (3) and the guide wire (8) cannot be retracted any further. [5] A mark (line or color) should be drawn on the needle tube (9) parallel to the rubber stopper (3), at the level where the wire is located directly at the cannula tip (1). This mark indicates whether the wire is distal to the cannula tip (1) or inside the metal cannula (6). We could call this position of the wire the zero point. [6] The syringe should be filled with fluid and the wire should be retracted to position zero or greater. The syringe should be purged of air and bubbles before use on the patient. [7] A structure could be added to the needle cone (7) to keep the wire always in the center. [8] One possible variation of the wire is a wire with a flexible spiral tip to navigate the tortuous vascular anatomy and thus enable atraumatic puncture. This wire variant has a straight position while the wire is still in the metal cannula (6). Coiling only occurs at the tip of the wire when it leaves the cannula tip (1). [9] A second variation is that the tip of the wire can be made thinner than the rest of the wire, so that the risk of perforation of the blood vessel can be reduced.

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