Catheter insertion method and device

Abstract

The present invention relates to a catheter insertion system comprising: an intravenous catheter comprising a distal cannula attached to a proximal hollow cannula seat; a forearm interconnected with a proximal portion of the intravenous catheter or an element connected to the proximal portion and extending distally therefrom; a frame, wherein the sleeve passes through the inside of the frame; the non-split finger holding part is arranged at the far end of the frame; and a needle configured to pass through the cannula and extend from the cannula. The invention also relates to a corresponding insertion method of the catheter insertion system.

Description

TECHNICAL FIELD

[0001] The present invention relates to intravascular catheter devices. More particularly, the present invention relates to methods and devices for facilitating intravenous catheterization. BACKGROUND

[0002] In the prior art, it is known to provide a peripheral venous therapy method using a catheter with a cannula or a catheter to provide access to a subcutaneous vein for the introduction of drugs, chemotherapy drugs, nutritional fluids and other fluids into the vein of a subject. The current procedure involves inserting a hypodermic needle together with a catheter with an indwelling cannula into a suitable vein, followed by withdrawing the needle and leaving the indwelling cannula in the vein. Such catheters are usually equipped with a suitable closure and various fitting mechanisms for the aseptic introduction of liquid drugs from a hypodermic syringe or an intravenous infusion device.

[0003] The insertion of the cannula into the venous system can be difficult and can lead to complications. The skilled medical practitioner must accurately puncture the skin at the correct location and insert the cannula into the correct blood vessel. Between the puncture phase and the insertion phase, the medical practitioner needs to have the skill to secure the catheter insertion system in place before insertion. Many times, the medical practitioner will accidentally "pull out" the cannula, resulting in the loss of the ideal insertion point location, which then requires a further attempt to puncture the subject for insertion of the catheter. This not only increases the workload, but also causes unnecessary pain and discomfort to the patient, as well as additional stress to the medical practitioner.

[0004] It has been shown in practice that longer cannulas, with an insertion length of 7-10 cm, especially those made of polyurethane, can reduce some of the common complications associated with shorter catheters and reduce the incidence of phlebitis. However, the insertion of longer catheters is more difficult because the holding point is further away from the insertion point, which reduces the stability of the operator and makes the insertion of the catheter into the vein more difficult.

[0005] In the Bard Powerglide Midline Catheter 2012 IFU, a solution aimed at reducing insertion complications is proposed, which catheter insertion system contains a guide wire. When the catheter is inserted into the blood vessel, the guide wire is also inserted into the blood vessel. The medical practitioner can then proceed with the subsequent steps with more confidence, as the guide wire is already in the target blood vessel and there is no risk of premature withdrawal. Subsequently, the catheter can be inserted distally along the guide wire.

[0006] This catheter device has a significant disadvantage: in order to prevent the premature withdrawal of the catheter and the loss of the ideal blood vessel insertion location, an additional guide wire needs to be inserted first, which is not necessary.

[0007] U.S. Patent No. 5,512,052 relates to a catheter insertion kit for placing a catheter in a blood vessel, the kit including a needle with a gripping device on the needle hub, and a catheter sleeved over the puncture needle and having a catheter hub.

[0008] U.S. Patent No. 7,291,128 relates to a sheath in which a fixed deflector is provided in the movement path of a slider. When the slider comes into contact with the deflector, the slider will tilt, thereby causing the needle to tilt inside the sheath.

[0009] European Patent No. 1437155 relates to a catheter with a needle and a cannula that can be inserted into a blood vessel in an organism using only one hand.

[0010] U.S. Patent No. 4,231,367 relates to an infusion catheter assembly including a catheter unit and an insertion needle unit, the tip of which extends with a flap. During insertion of the catheter unit into a vein, the user can grasp the flap with their fingers and pivot it inward to securely engage the catheter unit.

[0011] International Patent Application No. WO 2016 / 020923 relates to a catheter insertion method and apparatus.

[0012] The devices in the prior art fail to provide a sufficiently suitable means of insertion.

[0013] Therefore, one object of the present invention is to provide a method and apparatus for the controlled, safe and sterile insertion of an intravascular catheter into a peripheral blood vessel.

[0014] Another object of the present invention is to provide an intravascular catheter insertion system that includes means for preventing accidental removal of the catheter system.

[0015] Another object of the present invention is to provide an intravascular catheter insertion system that does not require a guidewire or other guiding device.

[0016] Other objects and advantages of the present invention will become apparent in the following description. Summary of the Invention

[0017] The present invention provides a catheter insertion system that allows for the controlled and sterile insertion of catheters and similar indwelling tubular elements into a vascular system via a percutaneous route.

[0018] The catheter insertion system includes a finger grip that allows the user to advance the catheter without releasing their grip, thus making the finger grip a single point of operation throughout the insertion process. This allows the insertion to be performed with one hand. According to one embodiment, the catheter insertion system also includes a stabilizing arm that keeps the catheter centered during skin puncture and subsequently shifts as the catheter hub passes through, thus not obstructing the operation.

[0019] This invention includes a single point of operation, meaning that the user holds the finger grip throughout the entire insertion and subsequent removal process, allowing for skin puncture, removal of the system frame, finger grip, and forearm without releasing the fingers, leaving the catheter in the patient's body. This design is convenient to use, highly stable, and reduces training time for medical staff.

[0020] The single operating point is achieved because the finger grip does not split, break, or undergo any geometric changes throughout the operation, which is a significant advantage over other insertion systems in the prior art.

[0021] It should be noted that, as used in this article, the term "proximal" refers to the part of the catheter device that is relatively close to the operator, while the term "distal" refers to the part of the catheter device that is relatively far from the operator.

[0022] This invention relates to a catheter insertion system, comprising:

[0023] Intravenous catheter, which includes a distal cannula attached to a proximal hollow cannula seat;

[0024] The forearm, which is interconnected with the proximal portion of the intravenous catheter or with elements connected to and extending distally therefrom;

[0025] A frame, with a sleeve passing through the interior of the frame;

[0026] An indivisible finger grip portion is located at the distal end of the frame;

[0027] A needle configured to pass through and extend from the sleeve.

[0028] In some embodiments, the forearm includes a distal forearm gripping portion.

[0029] In some embodiments, the distal forearm grip extends vertically upward from the distal end of the forearm.

[0030] In some embodiments, the forearm includes a plurality of tabs extending upward from its top.

[0031] In some embodiments, these protrusions are evenly spaced apart from each other.

[0032] In some embodiments, the protrusions are peak-shaped, and each protrusion has a vertical proximal side.

[0033] In some embodiments, the front end of the finger grip portion is provided with a groove, so that the farthest of the plurality of protrusions can be placed in the groove.

[0034] In some embodiments, the forearm includes a safety capsule attached to its proximal side (typically at its base);

[0035] The safety capsule is connected to the proximal side of the proximal cannula seat of the catheter via a Luer connection;

[0036] The needle pierces the safety capsule; and

[0037] The safety capsule is associated with the safety needle mechanism.

[0038] In some embodiments, the frame is in the form of a long, straight, hollow tube.

[0039] In some embodiments, the frame includes a top groove along its length.

[0040] In some embodiments, the system includes a splittable distal tube disposed at the distal end of the frame.

[0041] In some embodiments, the finger grip portion includes a first side plate and a second side plate;

[0042] The splittable distal tube includes a first half tube, which is connected to a first side arm, and the first side arm is connected to the distal portion of the first side plate.

[0043] The splittable distal tube includes a second half tube, which is connected to a second side arm, which is connected to the distal portion of the second side plate;

[0044] The first side arm is connected to the first side plate via a hinge joint; and

[0045] The second side arm is connected to the second side plate via a hinge joint.

[0046] In some embodiments, the needle includes a proximal needle hub; and

[0047] The proximal end of the frame is fixedly connected to the proximal pin hub.

[0048] In some embodiments, the finger grip portion includes two generally inclined side plates.

[0049] In some embodiments, the side plates of the finger grip portion are convexly curved.

[0050] In some embodiments, each side plate includes multiple slots and / or multiple holes.

[0051] In some embodiments, the system further includes a hemostatic element capable of being inserted into the cannula via the proximal end of the cannula;

[0052] The hemostatic elements include:

[0053] A distal cylindrical stop that can be placed inside a sleeve seat;

[0054] Two side arms extending proximally from the cylindrical stop; and

[0055] Two side flaps, each side flap extending proximally from the corresponding side arm of the two side arms;

[0056] Wherein, at least the distal cylindrical stop member comprises a soft material.

[0057] In some embodiments, the forearm includes a safety capsule attached to its base;

[0058] The safety capsule is connected to the proximal side of the proximal cannula seat of the catheter via a Luer connection;

[0059] The needle pierces the safety capsule; and

[0060] The safety capsule is associated with the safety needle mechanism;

[0061] The side wing extends proximally out of the sleeve seat; and

[0062] The safety capsule has two side grooves, with each side flap inserted into a corresponding groove within the groove.

[0063] In some embodiments, the forearm includes a plurality of spaced-apart folding slots positioned along the bottom of the forearm.

[0064] In some embodiments, the geometry of the frame cannot be changed.

[0065] In some embodiments, the geometry of the finger grip portion cannot be changed.

[0066] In some embodiments, the finger grip portion is a single point of operation.

[0067] In some embodiments, the catheter further includes flanks;

[0068] The frame includes two side arms, with the proximal end of the side arm connected to a mounting base connected to the needle hub, and the distal end connected to the finger grip.

[0069] This invention relates to a method for inserting an intravenous catheter (such as an intravenous catheter in the catheter insertion system described herein) into a patient's blood vessel, the method comprising the following steps:

[0070] A) Provides a forearm that is connected to a safety capsule, which is connected to a proximal seat (e.g., a cannula seat as described herein) of the intravenous catheter, from which the forearm extends distally;

[0071] B) Provides a finger grip for the catheter insertion system, which is interconnected with a needle passing through the intravenous catheter;

[0072] C) The user's fingers grip the finger grip portion (as a single point of operation);

[0073] D) Puncture the patient's blood vessel by moving the finger gripping part distally;

[0074] E) Advance the forearm distally and insert the cannula into the blood vessel until it is in place;

[0075] F) Retract the finger gripping part proximally until the needle tip is sealed inside the safety capsule;

[0076] G) Manipulate the proximal finger grip until the needle, safety capsule, and forearm are removed from the catheter;

[0077] H) Release the grip on the finger grip;

[0078] I) Secure the intravenous catheter to the patient's skin.

[0079] In some embodiments, step E includes:

[0080] The forearm is configured to include a plurality of spaced-apart tabs at its apex, and the forearm is advanced distally by periodically pushing a corresponding tab distally.

[0081] The present invention also relates to a method for inserting an intravenous catheter into a patient's blood vessel, the method comprising the following steps:

[0082] A) Provides a forearm that connects to the proximal seat of the catheter (such as the cannula seat described herein) or to other elements connected to the intravenous catheter, the forearm extending distally from the proximal seat or element;

[0083] B) Provides a finger grip for the catheter insertion system, which is interconnected with a needle passing through the intravenous catheter;

[0084] C) The user's fingers grip the finger grip portion;

[0085] D) Puncture the patient's blood vessel by moving the finger gripping part distally;

[0086] E) Advance the forearm distally and insert the cannula into the blood vessel until it is in place;

[0087] F) Retract the finger grip proximally until the needle tip passes proximally through the catheter hub or other element connected to the intravenous catheter and is removed from the catheter;

[0088] G) Release the grip on the finger grip;

[0089] H) Disconnect and remove the forearm from the catheter hub or other elements connected to the intravenous catheter;

[0090] I) Secure the intravenous catheter to the patient's skin.

[0091] In some embodiments, step E includes:

[0092] The forearm is configured to include a plurality of spaced-apart tabs at its apex, and the forearm is advanced distally by periodically pushing a corresponding tab distally. Attached Figure Description

[0093] This invention is illustrated by way of examples in the accompanying drawings, in which the same reference numerals denote similar elements, wherein:

[0094] Figure 1A A perspective view of an intravenous catheter according to an embodiment of the present invention is shown.

[0095] Figure 1B A perspective view of an intravenous catheter according to an embodiment of the present invention is shown.

[0096] Figure 2A A perspective view of the forearm is shown according to an embodiment of the present invention.

[0097] Figure 2B A side view of the forearm is shown according to an embodiment of the present invention.

[0098] Figure 2C A side view of the forearm is shown according to an embodiment of the present invention.

[0099] Figure 2D A side view of the forearm is shown according to an embodiment of the present invention.

[0100] Figure 2E A perspective view of the forearm is shown according to an embodiment of the present invention.

[0101] Figure 3 A perspective view of the forearm connected to an intravenous catheter according to an embodiment of the present invention is shown.

[0102] Figures 4A-4D A perspective view of a catheter insertion system at different positions is shown according to an embodiment of the present invention.

[0103] Figures 5A-5B A top view of the frame and finger grip of a catheter insertion system according to an embodiment of the present invention is shown.

[0104] Figures 6A-6E Various configurations of hemostatic elements according to embodiments of the present invention are shown.

[0105] Figures 7A-7E Various configurations of the forearm (or a portion thereof) according to embodiments of the present invention are shown.

[0106] Figure 8A catheter insertion system according to an embodiment of the present invention is shown. Detailed Implementation

[0107] This invention mainly relates to a catheter insertion system, comprising:

[0108] Intravenous catheters, including:

[0109] a) Hollow cannulas suitable for insertion into peripheral blood vessels;

[0110] b) The proximal end seat that connects to the distal end of the sleeve;

[0111] It can be connected to an intravenous catheter and configured with a front handle for distal manipulation of the intravenous catheter;

[0112] A finger grip portion that allows the user to firmly hold, manipulate, and position the system;

[0113] The frame of the protective sleeve (e.g., a single frame);

[0114] A needle used to puncture a patient's blood vessels in order to insert an intravenous catheter into the patient's blood vessels.

[0115] Typically, the system is ready for use when the needle connected to the base element is fully inserted into the sleeve and extends beyond the far end of the sleeve.

[0116] A needle is pierced through the skin and inserted into the venous system along with the distal tip of the cannula. Normally, blood flows from the distal tip into the cannula lumen, indicating that the cannula has been correctly positioned within the blood vessel. At this stage, existing devices require a healthcare professional to insert the cannula using a grip located at the proximal end of the device, which can sometimes cause the user to lose their forward grip, potentially leading to the cannula being pulled out of the body. This invention includes a forward grip arm interconnected with the cannula, allowing the user to insert the cannula without further movement of the inserting hand. This reduces the likelihood of losing the blood vessel due to the catheter tip accidentally dislodging from the puncture site before cannula insertion.

[0117] This invention is particularly applicable to the insertion of long intravenous catheters. For long intravenous catheters, the grip portion, located further back near the proximal end of the device, results in greater user discomfort and reduced stability during operation. Consequently, the risk of accidental dislodgement increases.

[0118] International Patent Application No. WO 2016 / 020923 discloses a forearm that can be attached to the proximal portion of an intravenous catheter or to an element thereon, the forearm extending distally from the portion. However, the catheter system disclosed in this patent may not be gripped securely and stably enough, thus requiring improvements in the controllability and operability of catheter systems with forearms.

[0119] The system provided by this invention allows the user to hold it firmly and fully control the insertion process, including precise displacement operations. The finger grip of this invention enables the user to hold the system securely. The user establishes a firm grip at the start of the operation, and this grip remains unchanged, unmoved, or released throughout the entire operation; that is, the finger grip is a single point of operation. The finger grip does not split, and the user does not need to release it before the operation ends. Needle withdrawal is also performed from the same grip point. Furthermore, the system's structure allows the user to perform the precise insertion steps described herein. Therefore, this system provides an effective means for the user to perform insertion operations in the most successful manner, avoiding accidental withdrawal, and potentially allowing for complete single-handed operation.

[0120] Figure 1A A perspective view of an intravenous catheter 1 in the catheter insertion system of the present invention is shown. In this preferred embodiment, the intravenous catheter 1 includes a hollow cannula 2 and a proximal hollow cannula seat 5 connected to the proximal end of the cannula 2. The cannula seat 5 allows connection to an intravenous infusion line and is capped between uses. The cannula seat 5 is hollow, allowing a needle 3 to pass through and enter the cannula 2, as will be described in detail below.

[0121] Figure 1B Another embodiment of the intravenous catheter 1' is shown. The intravenous catheter 1' also includes wings 5a and 5b for manual manipulation and fixation of the catheter with adhesive. Wings 5a and 5b extend from a proximal cannula seat 5', which allows connection to an intravenous infusion line and capping between uses. The cannula seat 5' is a hollow structure, allowing a needle 3 to pass through and enter the cannula 2', as will be described in detail below.

[0122] The present invention includes a forearm adapted to be interconnected with an intravenous catheter 1. The forearm is an elongated element configured to manipulate the intravenous catheter distally and proximally. In some embodiments, the forearm 10 ( Figure 2A The device includes a distal anterior grip for advancing the intravenous catheter 1 distally. The anterior grip is a component that can be held (and manipulated by the user) and attached to the forearm, so that the forearm moves when the user pushes or pulls the anterior grip. In this document, the terms "forearm" and "anterior grip" are used interchangeably. According to one embodiment, the distal anterior grip 12 extends vertically upward from the distal end of the forearm 10.

[0123] Figure 2A A perspective view of a forearm 10 is shown, which includes a safety capsule 6 (typically attached to the bottom of its proximal portion, which will be described in detail below). Figure 2A The safety capsule 6 is an integral part of the forearm 10 (e.g., formed as a single piece by injection molding). Figure 2B yesFigure 2A Side view.

[0124] Figure 2C Another embodiment of the forearm 10' is shown, wherein the forearm 10' is not an integral part of the safety capsule 6', but is connectable to the safety capsule 6' (e.g., via snap-fit, dedicated connecting element, snap-fit ​​tube clamp or other connection method). Figure 2D yes Figure 2C The illustrated embodiment is shown in a side view in the connected state. Figure 2E yes Figure 2D The illustrated embodiment is a perspective view. After connection, the forearm 10' can manipulate the safety capsule 6' connected to the cannula seat 5, thereby manipulating the catheter 1. It should be noted that in other embodiments (e.g., embodiments without a safety capsule), the forearm 10' can be connected to the cannula seat 5 in a similar manner to connecting to the safety capsule 6', thereby enabling manipulation of the catheter 1.

[0125] The present invention includes an extension extending in a direction different from the longitudinal axis of the forearm (vertical in some embodiments, but at any suitable angle). According to one embodiment of the invention, the forearm 10 includes a plurality of tabs extending upward from its top. These tabs are elements securely attached to the forearm, and a user can move the forearm by manipulating the tabs. The tabs may be planar structures securely attached to the top of the forearm or extending upward from the top. In some embodiments, the tabs 11 are evenly spaced apart from each other. These tabs 11 allow a user holding a finger grip to push the tab distally with another finger (of the same hand as the finger holding the finger grip), thereby moving the entire forearm 10 distally. Once a corresponding tab has been pushed to the maximum distance accessible to the user's finger, the user can move their finger proximally back to a second tab located proximal to that tab and push the second tab distally, thereby moving the entire forearm 10 distally, and so on, until the cannula is fully inserted. This process will be described in more detail below with reference to the accompanying drawings. Other components of the forearms 10 and 10' will be described later in conjunction with other accompanying drawings.

[0126] The tabs 11 can be of various sizes and configurations, such as being peak-shaped (e.g., triangular), and each tab may optionally have a vertical proximal side so that the user / operator can easily push the tab distally. In this way, the user / operator can insert the intravenous catheter using only one hand without releasing the grip on the finger grip, thus achieving a very stable insertion operation. This undoubtedly helps to improve the success rate of insertion and reduce the possibility of accidental withdrawal or operational errors.

[0127] Figure 3A forearm 10 interconnected with catheter 1 is shown. According to this embodiment, forearm 10 includes a safety capsule 6 (sometimes also called a safety slider). The safety capsule is associated with the safety needle mechanism used. The safety vascular puncture needle is designed to enter the patient's vascular system while providing protection for healthcare personnel by protecting the needle tip to prevent accidental needlestick injuries. The safety capsule 6 is a hollow (preferably cylindrical tubular) element that allows needle 3 to pass through it. Figure 3 The distal tip of needle 3 is shown. Needle 3 is freely slidable relative to safety capsule 6 (and safety capsule 6 is slidable along needle 3). When the needle tip passes through safety capsule 6, safety capsule 6 automatically detects the end of needle 3 and immediately locks to completely seal the distal tip of needle 3. Safety capsule 6 is preferably connected to the proximal side of proximal cannula seat 5 via a Luer connection. The forearm 10 of safety capsule 6 includes (e.g., Figure 3 (As shown) is connected to the proximal cannula seat 5 of the catheter, thus enabling distal or, in some cases, proximal manipulation of the catheter 1. Therefore, the catheter 1 is typically located below and parallel to the forearm 10.

[0128] According to other embodiments, the forearm may be an integral part of the sleeve seat 5.

[0129] An example of the working principle of the safety needle mechanism is as follows: The needle passes through a self-closing straight tweezers element. A thickened portion of the needle body a few millimeters in front of the needle tip prevents this thickened portion from passing through the proximal portion of the tweezers element when the needle is withdrawn proximally. The thickened portion is positioned such that when it reaches the proximal portion of the tweezers element, the distal edge of the distal closing arm of the tweezers element closes on the needle tip, and the entire tweezers element is locked at the distal portion of the needle, thus preventing accidental needlestick injury. According to some embodiments, the safety capsule 6, integrally formed with the forearm 10, is adapted and constructed to work in conjunction with the safety mechanism (e.g., by adding a self-closing straight tweezers element, spring, etc., after the outer capsule 6 is formed).

[0130] Figure 4AA catheter insertion system 100, ready for insertion into a patient, is shown. The catheter insertion system 100 includes a frame through which a catheter 1 passes. The frame is a robust, elongated element designed to protect the cannula passing through it (preventing the user from contacting the cannula and preventing other external objects / factors from contacting the cannula). Preferably, the frame 30 is in the form of an elongated, straight, hollow tube. The frame 30 has a top groove 30s along its length. A forearm 10 is located above and parallel to the frame 30, through which the cannula 2 passes. The forearm 10 is interconnected with the catheter 1, with a connection extending along the groove 30s between them. The proximal end of the frame 30 is typically fixedly connected to a needle proximal seat 7. The needle 3 extends from the needle seat 7 into the interior of the frame 30, passing through a safety capsule 6, a cannula seat 5, and the cannula 2. The distal / proximal movement of the needle 3 is synchronized with the distal / proximal movement of the frame 30. Preferably, the needle seat 7 is connected to the proximal portion of the frame 30 (therefore, the distal / proximal movement of the needle coincides with the movement of the frame). Element 8 is a filter used to prevent blood from spraying upwards along the needle (only air is allowed to pass through).

[0131] The catheter insertion system 100 also includes a finger grip located at the distal end of the frame 30. This finger grip, connected to and located at the distal end of the frame, is a robust component that allows healthcare personnel to firmly grip and manipulate the catheter insertion system. The finger grip 20 is typically an integral part of the frame 30 (e.g., integrally formed by a single injection molding process). The finger grip includes laterally extending portions, preferably with a structure designed for comfortable user gripping. According to one embodiment, the finger grip 20 includes two generally inclined side plates 20p, preferably extending upward from an imaginary plane located at a height at the midpoint of the frame 30. The side plates are preferably convexly curved (the line connecting any two points on the side plate lies above the curve of the side plate between those two points), facilitating a firm grip by the user's fingers. Preferably, each side plate 20p includes a plurality of slots 20s (preferably parallel to each other) along the width direction of each side plate 20p, which facilitate a firm grip of the finger grip 20 by the user. The curved shape of the side plate 20p allows the fingers to fit naturally, and the lower lip structure of the finger grip 20 prevents the fingers from contacting the patient's skin. In other embodiments, multiple holes may be used instead of slots to achieve a secure grip. The distal portion of the frame 30 is located below the side plate 20p. The forearm 10 passes below the elongated apex of the grip 20, i.e., below the point where the side plates 20p interlock. In effect, the forearm 10 passes through the space inside the finger grip 20, with the conduit 1 located below it. The conduit 1 is positioned to pass through (or below) the finger grip 20 in some embodiments. The finger grip 20 is a single-piece structure, which may be manufactured by a single injection molding process or formed by connecting the side plates together. The finger grip 20 will not split.

[0132] The geometry of the frame of the present invention is preferably immutable, that is, the shape of the frame will not change during the entire insertion process (e.g., it will not split, the parts will not move relative to each other, and no parts will break off). Similarly, the geometry of the finger gripping part of the present invention is preferably immutable, that is, the shape of the finger gripping part will not change during the entire insertion process (e.g., it will not split, the parts will not move relative to each other, and no parts will break off).

[0133] Figure 4B The diagram shows a catheter insertion system 100 with catheter 1 partially maneuvered distally. The advancement of catheter 1 is typically performed using the following steps: First, the catheter insertion system 100 is in... Figure 4A The configuration is shown. The user / operator (right-handed user) grasps the finger grip 20 with their right hand, pressing the left side plate 20p with their thumb and the right side plate 20p with their middle finger. Then, they push the distal front grip 12 distally with their right index finger. When the distal front grip 12 is pushed to the maximum distance reachable by the index finger, the user moves their finger proximally back to the first tab 11a located proximal to the distal end of the distal front grip 12 and pushes the first tab 11a distally with their index finger (thus moving the entire forearm 10 distally). When the first tab 11a is pushed to the maximum distance reachable by the index finger, the user moves their finger proximally back to the second tab 11 located proximal to the first tab 11a and pushes the second tab 11 distally with their index finger (thus moving the entire forearm 10 distally). Similarly, the user then pushes the third tab 11 (located proximal to the second tab 11), and so on, until the cannula 2 is fully inserted.

[0134] After the cannula 2 is fully inserted, the user pulls the frame 30 proximally, causing the needle 3 (in embodiments where the needle hub 7 is connected to the proximal portion of the frame 30) to move proximally, exiting the cannula 2 and cannula hub 5 and being captured by the safety capsule 6. Figure 4C (As shown in the image). The safety capsule 6 is released from the cannula seat 5, and the interconnected components, including the forearm 10, safety capsule 6, needle 3, frame 30, and finger grip 20, are removed as a whole. Figure 4D As shown), it is usually discarded. Then, the user / operator usually holds catheter 1 with the other hand and secures it to the patient (cannula 2 has been inserted into the blood vessel).

[0135] Optionally (according to one embodiment), the safety capsule 6 is separated from the cannula seat 5 by means of friction, which is greater than the force required to slide the needle 3 backward through the safety capsule 6. When the needle 3 is locked inside the capsule 6, the pulling force is greater than the friction, and the capsule 6 is pulled out / retracted from the cannula seat 5.

[0136] According to one embodiment of the present invention, the front end of the finger grip portion 20 includes a groove 20r, such that the first protrusion 11a can be placed within the groove 20r (e.g., Figure 4A (As shown). This is an additional safety mechanism that prevents the catheter 1 from being prematurely advanced distally before the operator / user is ready to puncture and insert the catheter 1 into the patient's blood vessel. Therefore, the user can hold the finger grip 20 without worrying about accidentally advancing the catheter 1 distally, because the finger cannot access the tab 11a located within the groove 20r in a way that advances the tab 11a. The risk of accidentally advancing the catheter 1 distally by pushing the handle 12 is also less (the handle 12 is farther from the user's finger and usually requires deliberate manipulation to advance distally). Optionally, the first tab 11a may be different in size from the other tabs 11 (e.g., larger).

[0137] According to one embodiment of the invention, the catheter insertion system includes a splittable distal cannula disposed distal to the frame and finger grip. The splittable cannula is configured to secure the cannula at approximately the midpoint of the cannula, enhancing its rigidity and essentially providing a support point to reduce cannula flexibility, while allowing the cannula to slide smoothly through the hollow channel. Splittable distal cannula 70 ( Figure 5A and 5B (Seen in a top view) The tube includes a first half-tube 70a connected to a first side arm 71a, which is connected to the distal portion of a first side plate 20p; and a second half-tube 70b connected to a second side arm 71b, which is connected to the distal portion of a second side plate 20p. The first side arm 71a is connected to the corresponding first side plate 20p via a hinge joint, allowing the first side arm 71a and the first half-tube 70a to swing open horizontally. Similarly, the second side arm 71b is connected to the corresponding second side plate 20p via a hinge joint, allowing the second side arm 71b and the first half-tube 70b to swing open horizontally. A split distal tube 70 provides additional support and protection for the cannula 2 passing through it. When the catheter cannula seat 5 moves distally and contacts the proximal end of the split distal tube 70, the split distal tube 70 splits open, and the side arms 71a and 71b move distally about their respective hinge joints. The split distal tube 70 is also configured to accommodate a needle sheath that needs to be removed before use.

[0138] According to one embodiment of the invention, the catheter insertion system includes a hemostatic element capable of being placed within a catheter cannula seat. This hemostatic element is made of a plug-forming material and configured to block the cannula seat, preventing blood from flowing out proximally. The hemostatic element 60 is placed within the cannula seat 5 through the proximal end of the cannula seat 5. The hemostatic element 60 includes a distal cylindrical stop 61 disposed within the cannula seat 5 (located in a dedicated recess), two side arms 62 extending proximally from the cylindrical stop 61 (also disposed within the cannula seat 5), and two side flaps / flaps 63, each side flap 63 extending proximally from a corresponding side arm 62 of the two side arms 62. The side flaps 63 extend proximally out of the cannula seat 5 and engage with the side of a safety capsule 6 (in embodiments with a safety capsule 6). The safety capsule 6 is provided with two side recesses, each side flap 63 being inserted into a corresponding recess, the size and shape of which are preferably complementary to the side flap 63. When the safety capsule 6 is removed from the sleeve seat 5 towards the proximal end, the cylindrical stop 61 remains inside the sleeve seat 5, and the side flap 63 disengages from the groove (usually the distal end of the groove is open).

[0139] Needle 3 passes through the cylindrical stop 61 (usually through its center), as... Figure 6B As shown. The hemostatic element 60 preferably comprises a soft material selected from rubber, silicone, and ethylene-vinyl acetate copolymer (EVA). Alternatively, any other suitable elastomeric material may be used. According to other embodiments, portions 62 and 63 may be rigid, and only portion 61 (or the central portion of portion 61 in contact with the needle 3) may comprise a soft material.

[0140] Therefore, the material of the cylindrical stop 61 can tightly wrap around the needle 3, forming a good seal. Even if the needle 3 is removed proximally from the hemostatic element 60, the material will close the hole created by the needle 3, thereby sealing the cannula seat 5 and preventing blood from flowing out of the cannula seat 5. However, the friction between the material of the cylindrical stop 61 and the needle 3 is insufficient to pull the cylindrical stop 61 out along with the needle 3 when it is removed proximally, and the hemostatic element 60 will remain in the cannula seat 5. When it is necessary to connect the intravenous infusion line to the cannula seat 5, the hemostatic element 60 can be pulled proximally through the side flap 63. Between two uses of the infusion line, the hemostatic element 60 can be reinserted into the cannula seat 5 for resealing. Figure 6C A hemostatic element 60 is shown, which is placed inside the cannula seat 5 and has side flaps 63 extending proximally. Figure 6D The figure shows a hemostatic element 60 placed within a cannula seat 5, and a safety capsule 6 connected to the cannula seat 5 with side flaps 63 located on the side of the safety capsule 6. An interconnected forearm 10 is also shown in the figure. Figure 6E A cylindrical stop 61 with a cylindrical groove at its proximal end is shown.

[0141] Figures 7A-7DAn embodiment of the invention is shown, wherein the forearm 10'' is provided with a plurality of folding slots 18. The folding slots 18 are spaced apart along the bottom of the forearm 10'', allowing the forearm 10'' to bend upward. Figure 7A The forearm 10'' is shown in a bent position. Figure 7B The forearm 10'' is shown in an extended position. Figure 7C It shows Figure 7A A close-up view of a single folding slot 18. Figure 7D It shows Figure 7B A close-up view of a single folding slot 18.

[0142] Figure 7E An embodiment of the forearm 10''' is shown, in which a plurality of tabs 11 are distributed adjacently along most of the length of the forearm 10''' (or the minimum distance between each tab is, for example, 2 mm, 3 mm, 4 mm, 5 mm, 7 mm, 10 mm). Figure 7A The embodiment shown has an upwardly curved shape (partially arcuate) during manufacturing and is forced straightened during assembly, thereby generating an upward elastic force that causes it to bend as it is pushed toward the distal end (since it still has the tendency to return to its original arcuate shape, it causes the portion extending from the finger grip 20 to fold upward, effectively having a spring-like motion effect).

[0143] Figure 8 Another embodiment of the catheter insertion system 200 of the present invention is shown, which employs a non-cylindrical frame 35 including two side arms 35a and 35b. The two side arms 35a and 35b provide further protection for the cannula 2 and generally prevent finger contact with the cannula 2. It should be noted that portions of the frame 35 may be circular / cylindrical (e.g., its proximal portion), but not necessarily cylindrical along its entire length (instead having elongated side arms). This assembly allows the use of winged catheters (e.g., see reference...). Figure 1B (The described catheter). This embodiment does not limit the size of the upper flanks of the catheter, which provide a secure fixation effect after insertion, securing the catheter to the patient. The proximal ends of the side arms 35a and 35b are connected to the mounting base 36 mounted on the needle hub 7, and the distal ends are connected to the finger grip portion 20. Preferably, the needle hub 7 is connected to the proximal portion of the frame 35 (or may be an integral part thereof). Elements 7, 35, and 36 may be a single integral part or interconnected to form a single unit.

[0144] According to one embodiment of the invention, the intravenous catheter is a standard intravenous catheter, such as the Introcan Safety® catheter from B. Braun, Germany. According to one embodiment, the elements 2, 20, 10, 10', 10'', 11, 11a, 12, 30, 35, 5, 5', 5a, 5b, 6, 6', 70, 71a, 71b, and 7 of the catheter insertion system 100, 200 comprise materials selected from polypropylene, polyurethane, polytetrafluoroethylene (PTFE), polyethylene, and nylon. Other polymer materials with similar properties may also be used. The needle 3 preferably comprises a material selected from 304 stainless steel, 316 stainless steel, and 316L stainless steel. Optionally, the forearms 10, 10', 10'' comprise a flexible material (allowing the cannula to be pulled at different angles (the angle between the forearm and the cannula)). This helps prevent the user's (clinician's) hand from being obstructed by the patient's hand and allows the user to pull the cannula at a greater angle. The components described in this article are manufactured / processed using conventional methods, such as molding, machining, etc.

[0145] The diameter of the intravenous catheter cannula 2 is preferably between 0.5 mm and 2 mm, and the length is preferably between 4 and 15 cm, with 8 cm being the most preferred. The dimensions of the flanks, cannula seat, end portion, and valve are the same as those of existing standard catheters.

[0146] Safety capsules 6 and 6' (in addition to or alternative to the materials described herein) may comprise materials selected from steel, titanium, and polymers. Commercial examples of such capsules 6 include the Healcath™ Passive Safety Straight Intravenous Cannula and the ECOCANN S: Safety Intravenous Cannula.

[0147] The dimensions of known components in the catheter system (e.g., cannula, seat, needle, flank, safety capsule) preferably conform to the dimensions of similar standard components in the prior art (based on various dimensional variations known in the prior art). Other components (e.g., frame, forearm, finger grip, side plate) may have various dimensions, such as those shown in the figures relative to known catheter system components appearing in the figures. However, it should be understood that the dimensions (length, width, thickness, height, diameter) of these other components are not limited to those shown in the figures and can be adjusted.

[0148] The present invention also relates to a method for inserting an intravenous catheter into a patient's blood vessel using the apparatus described in all of the above embodiments (and all combinations thereof). Some steps of this method have been described above.

[0149] This invention relates to a method for inserting an intravenous catheter into a patient's blood vessel. The method also includes the steps described herein related to the system of this invention. The method of this invention includes the following steps:

[0150] A) Provide a forearm (e.g., 10) connected to a safety capsule (6), which is connected to a proximal cannula seat (5) of the intravenous catheter (1), the forearm extending distally from the proximal cannula seat;

[0151] B) Provides a finger grip (20) for the catheter insertion system, which is interconnected with a needle (e.g., a needle hub connected to a frame) passing through the intravenous catheter;

[0152] C) Hold the finger grip with the user's fingers (e.g., press one end with the thumb and the other end with the middle finger).

[0153] D) Puncture the patient's blood vessel by moving the finger gripping part distally;

[0154] E) Advance the forearm distally and insert the cannula into the blood vessel until it is in place;

[0155] F) Retract the finger grip proximally until the needle tip is encapsulated within the safety capsule (as described herein);

[0156] G) Manipulate the proximal finger grip (which is connected to the needle and, after the needle is encapsulated by the safety capsule, is also connected to the safety capsule and the forearm) until the needle, safety capsule, and forearm are removed from the catheter (which are usually discarded).

[0157] H) Release the grip on the finger grip;

[0158] I) Secure the intravenous catheter to the patient's skin.

[0159] In some embodiments, step E includes:

[0160] The forearm is configured to include a plurality of spaced-apart tabs (11, 11a) at its apex, which are used to advance the forearm distally by periodically pushing (e.g., with an index finger) a corresponding tab (as described herein).

[0161] According to another embodiment, the method of the present invention includes the following steps:

[0162] A) Provides a forearm (e.g., 10) for connecting to the proximal cannula seat (5) of the catheter or to other elements connected to the intravenous catheter (1), the forearm extending distally therefrom;

[0163] B) Provides a finger grip (20) for the catheter insertion system, which is interconnected with a needle (e.g., a needle hub connected to a frame) passing through the intravenous catheter;

[0164] C) Hold the finger grip with the user's fingers (e.g., press one end with the thumb and the other end with the middle finger).

[0165] D) Puncture the patient's blood vessel by moving the finger gripping part distally;

[0166] E) Advance the forearm distally and insert the cannula into the blood vessel until it is in place;

[0167] F) Retract the finger grip proximally until the needle tip passes proximally through the catheter hub or other element connected to the intravenous catheter and is removed from the catheter;

[0168] G) Release the grip on the finger grip;

[0169] H) Disconnect and remove the forearm from the catheter hub or other elements connected to the intravenous catheter;

[0170] I) Secure the intravenous catheter to the patient's skin.

[0171] In some embodiments, step E includes:

[0172] The forearm is configured to include a plurality of spaced-apart tabs (11, 11a) at its apex, which are used to advance the forearm distally by periodically pushing (e.g., with an index finger) a corresponding tab (as described herein).

[0173] The examples and descriptions above are for illustrative purposes only and are not intended to limit the invention in any way. Those skilled in the art will understand that the invention can be implemented in various ways, employing one or more of the techniques described above, all without departing from the scope of the invention.

Claims

1. A catheterization system comprising: an intravenous catheter comprising a distal hub attached to a proximal hub; a forearm interconnected with a proximal portion of the intravenous catheter or an element connected thereto and extending distally therefrom; a frame, wherein the hub passes through an interior of the frame; a non-segmentable finger grip disposed at a distal end of the frame; a needle configured to pass through and extend from the hub.

2. The catheterization system of claim 1, wherein, The forearm comprises a distal front grip.

3. The catheterization system of claim 2, wherein, The distal front grip extends vertically upward from a distal end of the forearm.

4. The catheterization system of claim 1, wherein, The forearm comprises a plurality of tabs extending upward from a top of the forearm.

5. The catheterization system of claim 4, wherein, The tabs are evenly spaced from one another.

6. The catheterization system of claim 4, wherein, The tabs are peak-like, each having a vertical proximal side.

7. The catheterization system of claim 4, wherein, A front end of the finger grip comprises a recess such that a distal-most tab of the plurality of tabs can be disposed within the recess.

8. The catheterization system of claim 1, wherein, The forearm comprises a safety capsule connected at a bottom thereof; wherein the safety capsule is connected to a proximal side of the catheter proximal hub by a luer connection; wherein the needle passes through the safety capsule; and wherein the safety capsule is associated with a safety needle mechanism.

9. The catheterization system of claim 1, wherein, The frame is in the form of a long, straight, hollow tube.

10. The catheterization system of claim 9, wherein, The frame comprises a top slot along a length thereof.

11. The catheterization system of claim 10, wherein, The catheterization system comprises a segmentable distal tube disposed at a distal end of the frame.

12. The catheterization system of claim 11, wherein, The finger grip comprises a first side panel and a second side panel; wherein the segmentable distal tube comprises a first half tube connected to a first side arm connected to a distal portion of the first side panel; wherein the segmentable distal tube comprises a second half tube connected to a second side arm connected to a distal portion of the second side panel; wherein the first side arm is connected to the first side panel by a hinged joint; and wherein the second side arm is connected to the second side panel by a hinged joint.

13. The catheter insertion system according to claim 1, wherein, The needle comprises a proximal needle hub; and wherein a proximal end of the frame is fixedly connected to the proximal needle hub.

14. The catheterization system of claim 1, wherein, The finger grip element comprises two substantially oblique side panels.

15. The catheterization system of claim 14, wherein, The finger grip element panels are convexly curved.

16. The catheterization system of claim 14, wherein, Each side panel comprises a plurality of slots and / or a plurality of holes.

17. The catheter insertion system according to claim 1, wherein, The catheterization system further comprises a hemostatic element disposable within the hub through a proximal end thereof; wherein the hemostatic element comprises: a distal cylindrical stopper disposable within the hub; two side arms extending proximally from the hemostatic cylindrical stopper; and two side flaps each extending proximally from a respective one of the two side arms; wherein at least the distal cylindrical stopper comprises a soft material.

18. The catheterization system of claim 17, wherein, The forearm comprises a safety capsule connected at a bottom thereof; wherein the safety capsule is connected to a proximal side of the catheter proximal hub by a luer connection; wherein the needle passes through the safety capsule; and wherein the safety capsule is associated with a safety needle mechanism. wherein the side flaps extend proximally out of the hub; and wherein the safety capsule comprises two side recesses, each of the side flaps being disposable within a respective one of the recesses.

19. The catheter insertion system of claim 1, wherein, The forearm comprises a plurality of spaced-apart folding slots placed along the bottom of the forearm.

20. The catheter insertion system of claim 1, wherein, The geometry of the frame is not changeable.

21. The catheter insertion system according to claim 1, wherein, The geometry of the finger grip is not changeable.

22. The catheter insertion system according to claim 1, wherein, The finger grip is a single point of operation.

23. The catheter insertion system according to claim 1, wherein, The catheter further comprises a wing; Wherein the frame comprises two side arms attached at their proximal end to a mounting base connected to a needle hub and connected at their distal end to the finger grip element.

24. A method of inserting an intravenous catheter into a blood vessel of a patient, wherein, The method comprises the following steps: A) providing a forearm connected to a safety capsule connected to a proximal hub of an intravenous catheter, the forearm extending distally from the proximal hub; B) providing a finger grip of a catheter insertion system, the finger grip being interconnected with a needle passing through the intravenous catheter; C) holding the finger grip by the fingers of a user; D) puncturing a blood vessel of a patient by moving the finger grip distally; E) advancing the forearm distally, thereby inserting a cannula into the blood vessel until in place; F) retracting the finger grip proximally until the needle tip is encapsulated within the safety capsule; G) manipulating the finger grip proximally until the needle, the safety capsule and the forearm are removed from the catheter; H) releasing the grip on the finger grip; I) securing the intravenous catheter to the skin of the patient.

25. The method of claim 24, wherein, Step E comprises: providing that the forearm comprises a plurality of spaced-apart tabs at its top, the forearm being advanced distally by periodically pushing a respective one of the tabs distally.

26. A method of inserting an intravenous catheter into a blood vessel of a patient, wherein, The method comprises the following steps: A) providing a forearm connected to a proximal hub of an intravenous catheter or to another element connected to the intravenous catheter, the forearm extending distally from the proximal hub or the other element; B) providing a finger grip of a catheter insertion system, the finger grip being interconnected with a needle passing through the intravenous catheter; C) holding the finger grip by the fingers of a user; D) puncturing a blood vessel of a patient by moving the finger grip distally; E) advancing the forearm distally, thereby inserting a cannula into the blood vessel until in place; F) retracting the finger grip proximally until the needle tip passes proximally through the catheter hub or the other element connected to the intravenous catheter and is removed from the catheter; G) releasing the grip on the finger grip; H) disconnecting the forearm from the catheter hub or the other element connected to the intravenous catheter and removing it; I) securing the intravenous catheter to the skin of the patient.

27. The method of claim 26, wherein, Step E comprises: providing that the forearm comprises a plurality of spaced-apart tabs at its top, the forearm being advanced distally by periodically pushing a respective one of the tabs distally.

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