Device for percutaneous catheterization of central vessels in hypovolemic patients

Abstract

FIELD: medical equipment.SUBSTANCE: invention relates to medical equipment, namely to a device for central vein catheterization. The device for central vein catheterization contains a puncture needle and a catheter attached to it, as well as a mechanism that limits the complete withdrawal of the needle from the catheter lumen, which is made in the form of an elastic spiral or thread with distal and proximal fixators located in the device connector. The distal tip of the catheter is made with a semi-drop extension on the upper plane and a beveled cut on the lower plane.EFFECT: use of the invention makes it possible to increase the effectiveness, safety and speed of central vein catheterization in patients with hypovolemia.1 cl, 2 dwg

Description

[0001] The invention relates to medical equipment, in particular to devices for vascular catheterization, and can be used for placing central venous catheters (CVC), primarily in the internal jugular vein, in patients in critical condition accompanied by hypovolemia.

[0002] Various devices for central venous catheterization based on the Seldinger technique are known. A typical device includes a puncture needle, a catheter attached to the needle, a guidewire, and a dilator. After the vessel is punctured with the needle, a catheter is advanced through the needle into the lumen. The needle is then removed, a guidewire is inserted through the catheter, and the catheter and needle are then removed, followed by the insertion of an indwelling catheter (RU 2573337 C1).

[0003] The device comprises a needle with a tube attached to it, which features a flow switch. The flow switch is a plug made of an elastic material with a self-compressing channel to prevent vessel embolism. The plug is secured to the conically expanded non-working end of the tube (SU 1805976 A3).

[0004] The disadvantage of this needle is the inability to ensure precise localization in the lumen of the vessel. The fact is that during puncture, in particular, of the internal jugular vein in hypovolemic patients, there is a very high probability of a through puncture and / or exit from the lumen of the vessel, which is associated with a high index of vein collapse, which can lead to damage to adjacent anatomical structures, bleeding and the formation of hematomas (Nigmatullina A.R., Kasatkin A.A., Urakov A.L. Dependence of the value of central venous pressure on the index of collapse of the internal jugular vein in patients with trauma and blood loss / / Politravma. 2017. No. 1. URL: https: / / suberleninkа.ru / article / n / zavisimost-velichiny-tsentralnogo-venoznogo-davleniya-ot-indeksa-kollabirovaniya-vnutrenney-yaremnoy-veny-u-patsientov-s-travmoy-i (date (Accessed: 28.12.2025)). The known needle contains a catheter placed on the needle, which, when a vessel is punctured, is pushed into the lumen of the vein and allows the insertion of a J-guide.At the same time, when removing the needle from the catheter lumen, there is a high probability that the catheter itself will exit the lumen of the vessel, which, first of all, will not allow the insertion of a J-shaped catheter, and will also lead to a number of significant complications:.

[0005] • High risk of through puncture and / or exit of the needle and catheter from the lumen of the collapsed vessel due to a high vein collapse index (Nigmatullina A.R., Kasatkin A.A., Urakov A.L. Dependence of the value of central venous pressure on the collapse index of the internal jugular vein in patients with trauma and blood loss / / Politravma. 2017. No. 1. URL: https: / / cyberleninka.ru / article / n / zavisimost-velichiny-tsentralnogo-venoznogo-davleniya-ot-indeksa-kollabirovaniya-vnutrenney-yaremnoy-veny-u-patsientov-s-travmoy-i (date of access: 10 / 31 / 2023)).

[0006] • Difficulty in holding the catheter in the lumen of the vessel at the moment of needle removal, which can lead to the catheter being pulled out of the vessel and the inability to insert the guidewire (Mey U. et al. Evaluation of an ultrasound-guided technique for central venous access via the internal jugular vein in 493 patients. Support Care Cancer 2003; 11: 148-155).

[0007] • Risk of perforation of the posterior wall of the vein when advancing the catheter.

[0008] • Risk of air embolism when disconnecting the syringe or removing the needle.

[0009] The objective of the invention is to improve the efficiency, safety and speed of central vein catheterization in patients with hypovolemia.

[0010] The technical result is achieved through a new design of the distal end of the catheter and the introduction of a limiting mechanism.

[0011] The essence of the invention is as follows. A polyurethane flexure catheter is attached to a standard puncture needle (Seldinger needle). The distal (working) tip of the catheter is modified: its upper surface is shaped like a semi-droplet, and its lower surface is beveled (Fig. 1). Furthermore, the device is equipped with an elastic coil mechanism that physically prevents the needle from being completely removed from the catheter (Fig. 2).

[0012] The semi-droplet extension at the tip of the catheter serves several functions:

[0013] • Allows the operator to tactilely feel the “gap” when entering the lumen of the vessel (“gap feeling”), which increases the accuracy of the puncture.

[0014] • Prevents the catheter from accidentally slipping out of the lumen of a collapsed vein, especially when the patient inhales, acting as a kind of “anchor”.

[0015] • Improves visualization of the catheter tip during ultrasound guidance in both longitudinal (in-plane) and transverse (out-plane) scanning by creating a more pronounced acoustic interface.

[0016] The beveled lower edge of the catheter tip facilitates its easier sliding along the inner wall of the vessel during advancement and reduces the risk of falling into the puncture hole and perforating the posterior wall of the vein in the event of inadvertent over-advancement. A mechanism that limits complete needle withdrawal prevents two major problems:

[0017] • Air embolism: the needle cannot be completely removed from the catheter until the guidewire is inserted, which prevents air from entering the lumen of the catheter connected to the vein.

[0018] • Loss of access: fixing the needle inside the catheter prevents accidental displacement and removal of the entire system from the vessel during manipulation.

[0019] Brief description of drawings:

[0020] Fig. 1. Design of the distal end of the catheter.

[0021] 1 - Needle;

[0022] 2 - Semi-drop extension;

[0023] 3 - Catheter.

[0024] Fig. 2. Design of the proximal end of the catheter.

[0025] 1 - Needle;

[0026] 3 - Catheter;

[0027] 4 - Catheter connection;

[0028] 5 - Catheter part of the connector;

[0029] 6 - Distal thread stopper in the thread chamber;

[0030] 7 - Needle part of the connector;

[0031] 8 - Proximal thread stopper;

[0032] 9 - Thread limiter;

[0033] 10 - Needle connection;

[0034] 11 - Flow switch plug;

[0035] 12 - Port for conductor;

[0036] 13 - Syringe port with cap;

[0037] 14 - Wings.

[0038] The method of using the device is as follows:

[0039] 1. Select a vein for catheterization and perform ultrasound visualization of the vein.

[0040] 2. After standard preparation of the surgical field and ultrasound visualization of the target vein (e.g., internal jugular), local anesthesia is performed.

[0041] 3. The device, attached to a syringe, is advanced under ultrasound guidance to the anterior wall of the vein. The puncture is performed as the patient exhales.

[0042] 4. After free flow of venous blood is obtained in the syringe, stop aspiration.

[0043] 5. Holding the needle still, gently advance the catheter sagittally forward 2-3 mm into the vessel lumen. A tactile sensation of "drop" confirms the presence of the expanded tip in the vein.

[0044] 6. The needle is carefully pulled back until its tip is inside the catheter, but not completely out of it, which is blocked by the limiting mechanism.

[0045] 7. A J-shaped guidewire is inserted into the lumen of the vessel through an additional port on the needle cannula.

[0046] 8. Next, fixing the conductor, the device is completely removed.

[0047] 9. A permanent central venous catheter is inserted through the guidewire, using a dilator if necessary.

[0048] We present a clinical example of the device’s use.

[0049] Patient M., 30 years old, with a body mass index of 27 kg / m 2A patient with clinical signs of hemorrhagic shock was admitted to the anesthesiology and intensive care unit for emergency diagnostic and treatment procedures. The patient was diagnosed with multiple trauma, a ruptured spleen, and internal bleeding. Due to clinical signs of hemorrhagic shock (blood pressure 80 / 50 mmHg, heart rate 130 bpm), the need for massive infusion and transfusion therapy, and vasopressor support), a decision was made to catheterize the central vein. Ultrasound examination of the internal jugular veins on the right and left revealed 70% collapse. A standard attempt at catheterization of the internal jugular vein on the right using the Seldinger technique resulted in a through-and-through puncture and hematoma formation. A decision was made to re-attempt catheterization of the internal jugular vein on the opposite (left) side. For this purpose, ultrasound imaging of the left internal jugular vein was performed. The surgical field was treated as usual and local anesthesia was administered under ultrasound guidance.The device, attached to a syringe, was advanced to the anterior wall of the vein under continuous ultrasound guidance. The puncture was performed as the patient exhaled. After free blood flow was achieved, the catheter was inserted 3 mm into the left internal jugular vein through the needle. A "drop" was felt. Using ultrasound guidance, the catheter was positioned within the left internal jugular vein. The needle was then gently pulled until movement was limited. The tip of the needle entered the catheter lumen but did not fully exit. A J-shaped guidewire was inserted into the vessel through an additional port on the cannula. After securing the J-shaped guidewire, the devices were removed. An indwelling catheter was inserted through the guidewire without the use of a dilator and secured with a ligature. The puncture and placement of the central venous catheter were completed quickly and without complications.

[0050] Thus, the proposed device, due to the new design of the distal end of the catheter and the restrictive mechanism for the needle, allows for increased accuracy, safety and efficiency of central vein catheterization in patients with hypovolemia, and reduces the number of complications and puncture attempts.

Claims

A device for catheterization of central veins, comprising a puncture needle and a catheter placed on it, characterized in that it contains a mechanism that limits the complete withdrawal of the needle from the lumen of the catheter, made in the form of an elastic spiral or thread with distal and proximal fixators located in the connector of the device, and the distal tip of the catheter is made with a semi-droplet expansion on the upper plane and a beveled cut on the lower plane.

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