Method and apparatus for inserting a catheter tube

Abstract

The present invention relates to a catheter insertion system comprising: an IV catheter comprising a distal cannula attached to a proximal hollow cannula hub; a forward arm interconnected to a proximal portion of said IV catheter or element connected thereto and extending distally therefrom; a frame wherein the cannula passes from within said frame; an unsplittable fingers grip placed at the distal end of said frame; a needle configured to pass through and protrude from said cannula. The present invention also relates to a corresponding method of insertion of the catheter insertion system.

Description

[0001] METHOD AND APPARATUS FOR INSERTING A CATHETER TUBE

[0002] Field of the Invention

[0003] The present invention relates to intravascular catheter devices. More particularly, the invention relates to methods and apparatuses for facilitating the insertion of an IV catheter.

[0004] Background of the Invention

[0005] It is known in the art to provide peripheral intravenous therapy using a catheter having a cannula or catheter tube to provide access into subcutaneous veins thereby to introduce medication, drugs, chemotherapy, nutrition and various other fluids into a vein of a subject. The present procedure includes inserting a hypodermic needle together with a catheter having an in-dwelling cannula into a suitable vein, withdrawing the needle and leaving the in-dwelling cannula in the vein. Such a catheter is typically provided with a suitable closure and various adapter mechanisms to enable the aseptic introduction of fluid medicaments from a hypodermic syringe or from an intravenous drip.

[0006] Inserting a cannula into the intravenous system can be difficult and is prone to complications. Skilled medical personnel must puncture the skin correctly at a correct location and insert the cannula in a correct blood vessel. Between the puncturing stage and the insertion stage the medical personnel must have the skill to hold the catheter insertion system in place prior to the insertion. Many times, the medical personnel accidentally “pulls out” the cannula, losing the ideal insertion point location resulting in further attempts to puncture the subject to insert the catheter. This causes in addition to the expended effort, unnecessary pain and discomfort for the patient and unnecessary additional stress for the medical personnel.

[0007] It has been shown that insertion of a longer cannula, 7- 10cm, especially if it is made from polyurethane, reduces some of the noted complications typically associated with shorter catheters and reduces the appearance of phlebitis. Long catheters, however, are difficult to insert as the grip is quite far from the insertion site, a fact that reduces the stability of the operator and makes the insertion of a catheter to the vein more difficult.

[0008] The Powerglide Midline Catheter 2012 IFU of C.R. Bard Inc., provides a putative solution for the reduction of complicated insertions, by including in its catheter insertion system a guidewire. When the catheter is inserted into a blood vessel, a guidewire is inserted into the blood vessel, as well. Afterwards, the medical personnel can calmly arrange the next steps of the procedure because the guidewire is already in the desired blood vessel and there is no threat of an early pull out. Then the catheter tube is inserted distally along the guide wire.

[0009] A considerable disadvantage to this catheter device stems from the requirement to needlessly initially insert a guidewire to prevent an early pullout and loss of the desired blood vessel insertion location.

[0010] US 5,512,052 relates to catheterization set for placing a catheter in a blood vessel, comprising a needle with a needle hub carrying a grip device, a catheter surrounding the puncture needle and having a catheter hub.

[0011] US 7,291,128 relates to a sheath with a stationary deflector disposed on the path of the slider so that contact between the slider and the deflector causes the slider to be inclined and consequently causes the needle to be inclined inside the sheath.

[0012] EP 1437155 relates to a catheter with a needle and a cannula for the introduction thereof by means of only one hand into the blood conduits of a living being's body.

[0013] US 4,231,367 relates to an infusion catheter assembly, which includes a catheter unit and an insertion needle unit, provided with fins extending from the head of the insertion needle unit. The fins may be gripped by the fingers and pivoted inward to firmly engage the catheter unit during insertion of the catheter unit into a vein. WO 2016 / 020923 relates to a method and apparatus for inserting a catheter tube.

[0014] The prior art devices do not provide sufficient means for a suitable insertion.

[0015] It is therefore an object of the present invention to provide methods and means for the controlled, safe aseptic insertion of an intravascular catheter tube into a peripheral blood vessel.

[0016] It is another object of the present invention to provide an intravascular catheter insertion system comprising means for preventing accidental withdrawal of the catheter system.

[0017] It is a further object of the present invention to provide an intravascular catheter insertion system without the need of a guidewire or other guiding means.

[0018] Other objects and advantages of the invention will become apparent as the description proceeds.

[0019] Summary of the Invention

[0020] The present invention provides a catheter insertion system that may be used for the controlled, aseptic insertion of catheters and similar indwelling tubular elements into the vasculature by means of the transcutaneous route.

[0021] The catheter insertion system comprises a fingers grip allowing catheter advancement without the need of releasing the hand grasp from the fingers grip, thus the fingers grip being a single operating point throughout the entire insertion procedure. Thus, the insertion may be done with one hand. According to one embodiment, the catheter insertion system also comprises stabilizing arms that adapt to a hold the catheter centrally while penetrating the skin and subsequently are displaced, to move out of the way when catheter hub passes therethrough. The present invention comprises a single operating point, i.e., the fingers of the user hold the fingers grip throughout the entire insertion procedure and removal thereafter allowing the penetration of the skin and the removal of the system frame, fingers grip and forward arm from the catheter and patient body without the need to release the fingers allowing ease of use, stability and reduced training time for the medical personnel.

[0022] The single operating point is achieved by the fact that the fingers grip does not split, brake or have any geometry change throughout the procedure adding a great advantage over other prior art insertion systems.

[0023] It should be noted that the term "proximal" is used herein to refer to elements of the catheter device which are located in relative proximity to the operator, and the term, "distal" is used herein to refer to elements of the catheter device the location of which is relatively distant from the operator.

[0024] The present invention relates to a catheter insertion system comprising:

[0025] - an IV catheter comprising a distal cannula attached to a proximal hollow cannula hub;

[0026] - a forward arm interconnected to a proximal portion of said IV catheter or element connected thereto and extending distally therefrom;

[0027] - a frame wherein the cannula passes from within said frame;

[0028] - an unsplittable fingers grip placed at the distal end of said frame;

[0029] - a needle configured to pass through and protrude from said cannula.

[0030] In some embodiments, the forward arm comprises a distal forward grip.

[0031] In some embodiments, the distal forward grip extends upwards vertically from the distal end of the forward arm.

[0032] In some embodiments, the forward arm comprises a plurality of tabs extending upwards from the top of the forward arm. In some embodiments, the tabs are evenly spaced apart from one another.

[0033] In some embodiments, the tabs are in the form of peaks each having a vertical proximal side.

[0034] In some embodiments, the forward end of the fingers grip comprises a recess such that a most distal tab of the plurality of tabs is placeable within said recess.

[0035] In some embodiments, the forward arm comprises a safety capsule connected at its proximal side (typically at its bottom); wherein the safety capsule is connected to the proximal side of the catheter proximal cannula hub in a luer connection; wherein the needle passes through said safety capsule; and wherein said safety capsule is associated with a safety needle mechanism.

[0036] In some embodiments, the frame is in the form of an elongated straight hollow tube.

[0037] In some embodiments, the frame comprises a top slot along its length.

[0038] In some embodiments, the system comprises a splitable distal tube placed distal to the frame.

[0039] In some embodiments, the fingers grip element comprises a first side plate and a second side plate; wherein the splitable distal tube comprises a first half tube connected to a first side arm which is connected to the distal portion of said first side plate; wherein the splitable distal tube comprises a second half tube connected to a second side arm which is connected to the distal portion of said second side plate; wherein the first side arm is connected to the first side plate by means of a hinge joint; and wherein the second side arm is connected to the second side plate by means of a hinge joint.

[0040] In some embodiments, the needle comprises a proximal needle hub; and wherein the proximal end of the frame is fixedly connected to the proximal needle hub.

[0041] In some embodiments, the fingers grip element comprises two substantially diagonal side plates.

[0042] In some embodiments, the fingers grip element plates are curved in a convex manner.

[0043] In some embodiments, each side plate comprises a plurality of slots and / or a plurality of apertures.

[0044] In some embodiments, the system further comprises a blood stop element placeable within the cannula hub via its proximal end; wherein the blood stop element comprises: a distal cylindrical stopper member placeable within the cannula hub; two side arms extending proximally from the blood cylindrical stopper member; and two side flaps, each extending proximally from a respective side arm of the two side arms; wherein at least said distal cylindrical stopper member comprises soft material.

[0045] In some embodiments, the forward arm comprises a safety capsule connected at its bottom; wherein the safety capsule is connected to the proximal side of the catheter proximal cannula hub in a luer connection; wherein the needle passes through said safety capsule; and wherein said safety capsule is associated with a safety needle mechanism; wherein the side flaps extend proximally out of the cannula hub; and wherein the safety capsule comprises two side recesses wherein each flap is inserted within a respective recess of said recesses.

[0046] In some embodiments, the forward arm comprises a plurality of spaced apart folding slots placed along the bottom of the forward arm.

[0047] In some embodiments, the frame geometry is unchangeable.

[0048] In some embodiments, the fingers grip geometry is unchangeable.

[0049] In some embodiments, the fingers grip is a single operating point.

[0050] In some embodiments, the catheter further comprises side wings; wherein the frame comprises two side arms attached at their proximal ends to a mount connected to a needle hub and connected at their distal ends to the fingers grip element.

[0051] The present invention relates to a method for inserting an IV catheter (e.g. of the catheter insertion system as explained herein) into a blood vessel of a patient comprising the steps of:

[0052] A) providing a forward arm connected to a safety capsule that is connected to a proximal hub (e.g. the cannula hub explained herein) of said IV catheter, said forward arm extending distally therefrom;

[0053] B) providing a catheter insertion system fingers grip interconnected to a needle passing through said IV catheter;

[0054] C) grasping the fingers grip (as a single operating point) by means of a user’s fingers;

[0055] D) puncturing the patient's blood vessel by means of moving the fingers grip distally;

[0056] E) advancing said forward arm distally thus inserting the cannula into the blood vessel until it is in place; F) proximally retracting the fingers grip until the needle tip is encapsulated in the safety capsule;

[0057] G) maneuvering the fingers grip proximally until the needle, the safety capsule and the forward arm are removed away from the catheter;

[0058] H) releasing the grasp of the fingers grip.

[0059] I) fixing the IV catheter to the patient's skin.

[0060] In some embodiments, step E comprises: providing that the forward arm comprises a plurality of spaced apart tabs on its top, advancing said forward arm distally by means of periodically distally pushing a respective tab of said tabs.

[0061] The present invention relates to a method for inserting an IV catheter into a blood vessel of a patient comprising the steps of:

[0062] A) providing a forward arm connected to a catheter proximal hub (e.g. the cannula hub explained herein) or other element that is connected to said IV catheter, said forward arm extending distally therefrom;

[0063] B) providing a catheter insertion system fingers grip interconnected to a needle passing through said IV catheter;

[0064] C) grasping the fingers grip by means of a user’s fingers;

[0065] D) puncturing the patient's blood vessel by means of moving the fingers grip distally;

[0066] E) advancing said forward arm distally thus inserting the cannula into the blood vessel until it is in place;

[0067] F) proximally retracting the fingers grip until the needle tip proximally passes the catheter hub or other element that is connected to said IV catheter and is removed away from the catheter;

[0068] G) releasing the grasp of the fingers grip;

[0069] H) disconnecting and removing the forward arm from the catheter hub or from the other element that is connected to said IV catheter; I) fixing the IV catheter to the patient's skin.

[0070] In some embodiments, step E comprises: providing that the forward arm comprises a plurality of spaced apart tabs on its top, advancing said forward arm distally by means of periodically distally pushing a respective tab of said tabs.

[0071] Brief Description of the Drawings

[0072] The present invention is illustrated by way of example in the figures of the accompanying drawings, in which like references indicate similar elements and in which:

[0073] Fig. 1A illustrates a perspective view of an IV catheter according to an embodiment of the present invention.

[0074] Fig. IB illustrates a perspective view of an IV catheter according to an embodiment of the present invention.

[0075] Fig. 2A illustrates a perspective view of a forward arm according to an embodiment of the present invention.

[0076] Fig. 2B illustrates a side view of a forward arm according to an embodiment of the present invention.

[0077] Fig. 2C illustrates a side view of a forward arm according to an embodiment of the present invention.

[0078] Fig. 2D illustrates a side view of a forward arm according to an embodiment of the present invention.

[0079] Fig. 2E illustrates a perspective view of a forward arm according to an embodiment of the present invention.

[0080] Fig. 3 illustrates a perspective view of a forward arm connected to an IV catheter according to an embodiment of the present invention.

[0081] Figs. 4A-4D illustrate a perspective view of various positions of the catheter insertion system according to an embodiment of the present invention.

[0082] Figs. 5A-5B illustrate a top view of the catheter insertion system fram and fingers grip according to an embodiment of the present invention. Figs. 6A-6E show various configurations of the blood stop element according to embodiments of the present invention.

[0083] Figs. 7A-7E show various configurations of the forward arm (or portions thereof) according to embodiments of the present invention.

[0084] Fig. 8 shows a catheter insertion system according to an embodiment of the present invention.

[0085] Detailed Description of Preferred Embodiments

[0086] The present invention is primarily directed to a catheter insertion system comprising:

[0087] • an IV catheter that comprises: a) a hollow cannula suitable for insertion into a peripheral blood vessel; b) a proximal hub portion connected to the distal end of the cannula;

[0088] • a forward handle attachably interconnected to the IV catheter and configured to maneuver the IV catheter distally;

[0089] • a fingers grip for the user / operator to firmly grasp, manipulate and position the system;

[0090] • a frame (e.g. single frame) protecting the cannula;

[0091] • a needle for puncturing a patient’s blood vessel for insertion of the IV catheter within the patient’s blood vessel.

[0092] The needle, typically connected to a hub element, is inserted into the cannula all the way through wherein the needle extends beyond the distal end of the cannula, thus the system being ready for use.

[0093] The needle punctures the skin and is inserted with the cannula distal tip into the venous system. Typically, a flow of blood flows up the distal tip within the lumen of the cannula indicating a correct positioning within the blood vessel. At this stage Prior Art devices require the medical personnel to then insert the cannula into the body by means of a grip located at the proximal end of a device, which sometimes leads to losing the forward grip of the device, what can cause a pullout of the cannula from the body. The present invention comprises a forward grip arm interconnected to the cannula that enables the insertion of the cannula into the body without further moving the inserting hand. This reduces the possibility of losing the vein by unintentionally allowing the tip of the catheter to move out of the hole in the vein prior to the insertion of the cannula.

[0094] The present invention is particularly useful when using a long IV catheter. In cases of long IV catheters the grip located at the proximal end of a device is located at an even more proximal location, what causes even more discomfort and loss of stability. Thus, the chances of accidental pullout increase.

[0095] WO 2016 / 020923 teaches of a forward arm attachably connected to a proximal portion of an IV catheter or element connected thereto, which extends distally therefrom. However, grasping the catheter system therein may not be firm and stable enough and there is a need to improve control and maneuverability of a catheter system in conjunction with a forward arm.

[0096] The present invention provides a system with the ability to be firmly grasped and the insertion carried out with the user / operator in full control of the insertion steps that include delicate displacements. The present invention fingers grip enables the user to have a firm grasp of the system. The firm grasp is executed one time at the beginning of the procedure and the grasp does not change or move and is not released throughout the entire procedure, i.e., the fingers grip is a single operating point. The fingers grip does not split and the user does not need to release the fingers grip until the end of the procedure. The extraction of the needle is carried out from the same point of grasp. Furthermore, the system structure enables the user to perform delicate insertion steps as described herein. Thus, the system provides useful means that enables a user to carry out the insertion in a most successful manner, avoiding unintentional pullouts and can possibly be fully maneuvered and operated with one hand.

[0097] Fig. 1A shows a perspective view of an IV catheter 1 of the present invention catheter insertion system. In this preferred embodiment the intravascular IV catheter 1 comprises a hollow cannula 2 and a proximal hollow cannula hub 5 connected to the proximal end of the cannula 2. The cannula hub 5 allows connection to an intravenous infusion line and capping in between uses. The cannula hub 5 is hollow enabling the insertion of a needle 3 therethrough, and through the cannula 2 as will be explained herein.

[0098] Fig IB shows another embodiment of an IV catheter 1’. The IV catheter 1’ further comprises side wings 5a and 5b for manual handling and securing the catheter with adhesives. The wings 5a and 5b extend from the proximal cannula hub 5’, which allows connection to an intravenous infusion line, and capping in between uses. The cannula hub 5’ is hollow enabling the insertion of a needle 3 therethrough, and through the cannula 2’ as will be explained herein.

[0099] The present invention comprises a forward arm adapted to be interconnected to the IV catheter 1. The forward arm is an elongated element which is configured to maneuver the IV catheter distally and proximally. The forward arm 10 (Fig. 2A), in some embodiments, comprises a distal forward grip for advancing the IV catheter 1 distally. The forward grip is an element graspable by the user (and maneuverable by the user) and attached to the forward arm, such that when pushing / pulling the forward grip it moves the forward arm accordingly. The term "forward arm" and "forward handle" are used herein interchangeably. According to one embodiment, distal forward grip 12 extends upwards vertically from the distal end of the forward arm 10.

[0100] Fig. 2A shows a perspective view of the forward arm 10 comprising a safety capsule 6 (typically connected to its bottom at proximal portion thereof and will explained in detail hereinafter). The safety capsule 6 in Fig. 2A is an integral part of the forward arm 10 (e.g. formed by a single mold injection altogether). Fig. 2B is a side view of Fig 2A.

[0101] Fig 2C shows another embodiment of the forward arm 10’ wherein the forward arm 10’ is not an integral part of the safety capsule 6’ but rather connectable thereto (e.g. by a snap clip, by a dedicated connecting element, by a snap-on tube clip connection, or other connecting means). Fig. 2D is a side view of the embodiment of Fig. 2C while it is in its connecting mode. Fig. 2E is a perspective view of the embodiment of Fig. 2D. When connected, forward arm 10’ can maneuver the safety capsule 6’ which is connected to the cannula hub 5, thus the forward arm 10’ maneuvers the catheter 1. It should be noted that in other embodiments (e.g. in an embodiment without a safety capsule) that the forward arm 10’ may be connectable to the cannula hub 5 (in a similar manner as connectable to the safety capsule 6’ as explained hereinabove) thereby being capable of maneuvering the catheter 1.

[0102] The present invention comprises extensions that extend in a different direction from the forward arm than that of the longitudinal axis of the forward arm, in some embodiments, perpendicularly, but any acceptable angle is envisioned. According to an embodiment of the present invention, the forward arm 10 comprises a plurality of tabs extending upwards from the top of the forward arm 10. The tabs are elements firmly attached to the forward arm such that they can maneuver the forward arm. The tabs may be firm surfaces attached to the top of the forward arm or extending upwards therefrom. The tabs 11 are, in some embodiments, evenly spaced apart from one another. These tabs 11 allow for a user grasping the catheter insertion system by the fingers grip, to use another finger (of the same hand with the fingers on the fingers grip) to push a tab distally thereby pushing the entire forward arm 10 distally. After the respective tab has been pushed (e.g. to the full extent of the distance which the pushing finger reaches) the user can move his finger back proximally to a second tab which is proximal to the first tab (which has just been pushed) and push the second tab distally thereby pushing the entire forward arm 10 distally, and so on and so forth, until the canula is fully inserted. This will be better understood in conjunction with the figures explained hereinafter. Further elements of the forward arm 10, 10’ will be explained with reference to other figures hereinafter.

[0103] The tabs 11 may be in various sizes and configurations, e.g. in the form of peaks (e.g. triangular) each optionally having a vertical proximal side which makes it easy for a user / operator to push distally. In this manner the user / operator may insert the IV catheter with just one hand and without releasing the grasp on the fingers grip, thus contributing to a very stable insertion. This surely contributes to a successful insertion and decreases the chances of an accidental pullout or of a negligent insertion. Figure 3 shows the forward arm 10 interconnected to the catheter 1. According to this embodiment, the forward arm 10 comprises the safety capsule 6 (sometimes referred to as safety slider). The safety capsule is associated with a safety needle mechanism used. Safety vascular access needles are designed to obtain access to the vasculature of the patient along with providing protection to the medical personnel making it safe for them, such that the needle tip is protected thus preventing accidental needlestick to the medical personnel. The safety capsule 6 is a hollow preferably cylindrical tubular element which allows passage of needle 3 therethrough (the distal tip of needle 3 is shown in Fig. 3). The needle 3 is freely slidable in relation to safety capsule 6 (and the safety capsule 6 is slidable along needle 3). The safety capsule 6 automatically senses the end of the needle 3 and instantly locks out to fully encapsulate the distal needle tip of needle 3, when the needle tip passes therethrough. The safety capsule 6 is connected to the proximal side of the proximal cannula hub 5 preferably, in a luer connection. The forward arm 10, comprising the safety capsule 6, (Shown in Fig. 3) is connected to the catheter proximal cannula hub 5 and can thus maneuver the catheter 1 distally or in some cases proximally, if needed. Thus, the catheter 1 is typically positioned beneath the forward arm 10 and parallel thereto.

[0104] According to other embodiments, the forward arm may be attached as an integral part of the cannula hub 5.

[0105] An example of the mechanism of the safety needle mechanism is such that the needle passes through a self-closing straight tweezers element. A portion of the needle a few millimeters before its point edge comprises a thicker portion such that when pulled proximally the thicker portion cannot pass through the proximal portion of the tweezers element. The thick portion is placed such that when it reaches the proximal portion of the tweezers element the distal edges of the distal closing arms of tweezers element close on the tip edge of the needle and the whole tweezers element sits on the distal portion of the needle, thus preventing accidental needlestick. According to some embodiments, the safety capsule 6 formed as an integral part of the forward arm 10, is adapted and constructed to function with the safety mechanism (by adding the self-closing straight tweezers element, springs, etc. after the external capsule 6 is formed).

[0106] Fig. 4A shows the catheter insertion system 100 ready for use to be inserted within a patient. The catheter insertion system 100 comprises a frame through which the catheter 1 passes through. The frame is a firm elongated element that provides protection to the cannula passing from within (protection from the user from engaging the cannula and protection from other external items / factors from engaging the cannula). Preferably, the frame 30 is in the form of an elongated straight hollow tube. The frame 30 comprises a top slot 30s along its length. The forward arm 10 is placed above and parallel to the frame 30 whereas the cannula 2 extends through the frame 30. The forward arm 10 is interconnected to the catheter 1 where the connection item between the two passes along the slot 30s. The proximal end of the frame 30 is typically fixedly connected to the needle proximal hub 7. The needle 3 extends from the needle hub 7 to within the interior of the frame 30, through the safety capsule 6, through the cannula hub 5, through the cannula 2. The needle 3 moves distally / proximally with accordance to the distal / proximal movement of the frame 30. Preferably, the needle hub 7 is connected to the proximal portion of frame 30 (thus the distal / proximal movement of the needle is the same as that of the frame). Element 8 is a filter that prevents the blood from shooting up the needle and out of it (only air permeable).

[0107] The catheter insertion system 100 further comprises a fingers grip element placed at the distal end of the frame 30. The fingers grip element, connected and placed distal to the frame, is a firm element which a medical personnel user can firmly grip and maneuver the catheter insertion system. The fingers grip element 20 is typically an integral part of the frame 30 (e.g. formed by a single injection molding). The fingers grip comprises side extensions that are preferably, comfortably, graspable by the user. According to one embodiment, the fingers grip 20 comprises two substantially diagonal side plates 20p, preferably extending upwards from an imaginary surface, the imaginary surface being at the height of the middle of the frame 30. The side plates are preferably curved in a convex manner (a line between two given points on the plates being above the curve of the plate between those two points) contributing to enable a firm grasp by the user’s fingers. Preferably, the side plates 20p each comprise a plurality of slots 20s (preferably parallel one to another) along the width of each plate 20p which contribute to firmly grasp the fingers grip element 20. The plates 20p curvature allows the fingers to be in organic shape as they are curved forming a lower lip of the fingers grip 20 prevents the fingers from touching the skin of the patient. Other embodiments may include a plurality of apertures instead of the slots that contribute to the firm grasp. A distal portion of the frame 30 is placed beneath the side plates 20p. The forward arm 10 passes beneath the elongated apex line portion of the grip element 20, i.e. beneath where the side plates 20p engage each other. The forward arm 10 actually passes through a space within the fingers grip element 20, and the catheter 1 beneath the forward arm 10. The catheter 1 is positioned such that it passes through fingers grip element 20 (or in some embodiments beneath it). The fingers grip element 20 is an integral single portion, either by the entire element being constructed by a single mold or by the plates being connected one to the other. The fingers grip element 20 does not split.

[0108] The present invention frame geometry is preferably unchangeable, i.e. the shape of the frame does not change throughout the entire insertion procedure (e.g. does not split, portions thereof do not move one in relation to the other, portions thereof do not break off). Also, the present invention fingers grip geometry is preferably unchangeable, i.e. the shape of the frame does not change throughout the entire insertion procedure (e.g. does not split, portions thereof do not move one in relation to the other, portions thereof do not break off).

[0109] Fig. 4B shows the catheter insertion system 100 with the catheter 1 partially maneuvered distally. The advancement of the catheter 1 is typically carried out as follows. First, the catheter insertion system 100 is in the configuration of Fig. 4A. The user / operator (a right-hand user) grasps the fingers grip 20 with his right-hand thumb engaging the left side plate 20p and with his right-hand middle finger engaging the right-side plate 20p. Then, the distal forward grip 12 is pushed distally by the right-hand index finger. After the distal forward grip 12 has been pushed (e.g. to the full extent of the distance which the index finger reaches) the user moves his finger back proximally to a first tab Ila which is proximal to the distal forward grip 12 (which has just been pushed) and pushes the first tab Ila distally with the index finger (thereby pushing the entire forward arm 10 distally). After the first tab Ila has been pushed (e.g. to the full extent of the distance which the index finger reaches) the user moves his finger back proximally to a second tab 11 which is proximal to the first tab Ila (which has just been pushed) and pushes the second tab 11 distally with the index finger (thereby pushing the entire forward arm 10 distally). Similarly, the user then pushes a third tab 11 (proximal to the second tab 11), and so on and so forth, until the canula 2 is fully inserted.

[0110] After the canula 2 is fully inserted, the frame 30 is pulled proximally by the user, and thus the needle 3 (in the embodiment wherein needle hub 7 is connected to the proximal portion of frame 30) connected thereto moves proximally out of the cannula 2, out of the cannula hub 5 and caught in the safety capsule 6 (position shown in Fig. 4C). The safety capsule 6 is released from the cannula hub 5 and the interconnected elements that include the forward arm 10, the safety capsule 6, the needle 3, the frame 30 and the fingers grip 20 are removed as a whole (shown in Fig. 4D) and typically disposed of. Then, the catheter 1, typically held by the second hand of the user / operator, is fixed to the patient (with the cannula 2 inserted within the blood vessel).

[0111] Optionally (according to one embodiment), the removal of the safety capsule 6 from cannula hub 5 is such that the safety capsule 6 is maintained connected to cannula hub 5 by friction greater than the force needed to slide the needle 3 back through it. When the needle 3 is locked within capsule 6 the pulling force is greater that the friction force and the capsule 6 is pulled / retrieved away from the cannula hub 5.

[0112] According to an embodiment of the present invention the forward end of the fingers grip 20 comprises a recess 20r such that the first tab Ila is placed within the recess 20r (as shown in Fig. 4A). This is an addition type of safe-operation mechanism, that does not allow the catheter 1 to prematurely advance distally, before the operator / user is ready to puncture and insert the catheter 1 into the patient blood vessel. Thus, the user can grasp the fingers grip 20 without being concerned of an accidental distal advancement, as the finger cannot engage the tab Ila (as it is within recess 20r) in a manner to advance it. There is less concern of an accidental distal advancement of catheter 1 by pushing handle 12 (which is more remote to the finger of the user and typically necessitates more planning to advance distally). Optionally, the first tab Ila may have a size different (e.g. greater) than that of the other tabs 11.

[0113] According to an embodiment of the present invention the catheter insertion system comprises a splitable distal tube placed substantially distal to the frame and fingers grip. The splitable tube is configured to hold the catheter in approximately mid length, stiffening the catheter and essentially supplying a support point to reduce flexibility but allowing the catheter to pass through a hollow pass and slide smoothly through it. The splitable distal tube 70 (shown in top view in Figs. 5A and 5B) comprises 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 respective first side plate 20p by means of a hinge joint such that the first side arm 71a and first half tube 70a are configured to swing open along a horizontal plane. Also, the second side arm 71b is connected to the respective second side plate 20p by means of a hinge joint such that the second side arm 71b and first half tube 70b are configured to swing open along a horizontal plane. The spliable distal tube 70 provides additional support and protection to the cannula 2 which passes therethrough. When the catheter cannula hub 5 moves distally and engages the proximal end of the splitable distal tube 70 it causes the splitable distal tube 70 to split open wherein the side arms 71a and 71b move distally around each respective hinge joint. The splitable distal tube 70 is also configured to hold a needle cover that is removed before use.

[0114] According to an embodiment of the present invention, the catheter insertion system comprises a blood stop element placeable within a catheter cannula hub. The blood stop element comprises material to form a plug and is configured to plug the cannula hub and prevent blood leaking out proximally therefrom. The blood stop element 60 is placed within the cannula hub 5 via its proximal end. The blood stop element 60 comprises a distal cylindrical stopper member 61 which is placed within the cannula hub 5 (within a dedicated recess), two side arms 62 extending proximally from the blood cylindrical stopper member 61 (also placed within cannula hub 5) and two side tabs / flaps 63, each extending proximally from a respective side arm 62 of the two side arms 62. The side flaps 63 extend proximally out of the cannula hub 5 and engage the sides of the safety capsule 6 (in cases with the embodiment comprising the safety capsule 6). The safety capsule 6 comprises two side recesses wherein each flap 63 is inserted within a respective recess, which is preferably complementary in size and shape. When the safety capsule 6 is removed proximally from cannula hub 5 cylindrical stopper member 61 remains within cannula hub 5 and the flaps 63 depart from the recesses (which typically have open distal ends).

[0115] The needle 3 passes through the cylindrical stopper member 61 (typically via its center), as shown in Fig. 6B. The blood stop element 60 preferably comprises soft material from the group consisting of rubber, silicon and EVA. Alternatively, any other suitable elastomer may be used. According to other embodiments, the portions 62 and 63 may be rigid and only the portion 61 (or the center portion of 61 which engages the needle 3) may comprise soft material.

[0116] Thus, the material of the cylindrical stopper member 61 closes tightly on the needle 3 and provides an excellent seal. Even when the needle 3 is proximally removed from the blood stop element 60 the material closes the hole caused by the needle 3 thereby sealing the cannula hub 5 and the blood does not exit the cannula hub 5. However, the friction between the cylindrical stopper member 61 material and the needle 3 is not big enough to cause the pulling out of the cylindrical stopper member 61 when the needle 3 is removed proximally, and the blood stop element 60 stays in place within cannula hub 5. When an intravenous infusion line is to be connected to cannula hub 5, the blood stop element 60 is pulled out proximally (by the flaps 63). The blood stop element 60 may be introduced in cannula hub 5 again for capping in between infusion line uses. Fig. 6C shows the blood stop element 60 placed within cannula hub 5 with the flaps 63 sticking out proximally. Fig. 6D shows the blood stop element 60 placed within cannula hub 5 and shows the safety capsule 6 connected to the cannula hub 5 and the flaps 63 at the sides of the safety capsule 6. The forward arm 10 is also shown interconnected. Fig. 6E shows the cylindrical stopper member 61 comprising a cylindrical recess at its proximal end.

[0117] Figs. 7A-7D show an embodiment of the present invention where the forward arm 10” comprises a plurality of folding slots 18. The folding slots 18 are spaced apart along the bottom of the forward arm 10” enabling the forward arm 10” to bend upwards. Fig. 7A shows the forward arm 10” in a bent configuration. Fig. 7B shows the forward arm 10” in a straight configuration. Fig. 7C shows a close up of a single folding slot 18 from Fig. 7A. Fig. 7D shows a close up of a single folding slot 18 from Fig. 7B.

[0118] Fig. 7E shows an embodiment of forward arm 10”’ being an embodiment with a plurality of tabs 11 adjacent to one another along most of the forward arm 10”’ (or with a minimal distance between each one being, e.g. 2mm, 3mm, 4mm, 5mm, 7mm, 10, mm). The embodiment of Fig. 7A is such that it is manufactured with an upward bend (partial arc form) and is forced to be straightened when assembled causing an upward spring action making it curve as it advances distally (as it remains with the “will” to move upwards and retain its original arc shape thus promoting the folding upwards of the portion exiting the fingers grip element 20, effectively having a spring like motion).

[0119] Fig 8 shows another embodiment of a catheter insertion system 200 of the present invention with a non-cylindrical frame 35 comprising two side arms 35a and 35b. The two side arms 35a and 35b provide further protection of cannula 2, and generally prevent fingers from touching cannula 2. It should be noted that portions of the frame 35 may be circular / cylindrical (e.g. the proximal portion thereof) but is not cylindrical along its entire length (rather it has elongated side arms). This assembly allows the use of a winged catheter (e.g. as explained with reference to Fig. IB). This embodiment does not limit the size of the wings on the catheter which can provide a robust fixation to the body after insertion. The side arm 35a and 35b are attached at their proximal ends to mount 36 mounted on the needle hub 7, and connected at their distal ends to the fingers grip element 20. Preferably, the needle hub 7 is connected to the proximal portion of frame 35 (or may be an integral part thereof). Elements 7, 35 and 36 may be a single integral part or interconnected thereto.

[0120] According to an embodiment of the present invention the IV catheter is a standard IV catheter such as Introcan Safety® catheter of the B Braun company. According to an embodiment, the catheter insertion system 100, 200 elements 2, 20, 10, 10’, 10”, 11, Ila, 12, 30, 35, 5, 5’, 5a, 5b, 6, 6’, 70, 71a, 71b and 7 comprise material from the group consisting of Polypropylene, Polyurethane, PTFE, Polyethylene and Nylon. Other polymers with similar qualities may also be used. The needle 3 preferably comprises material from the group consisting of stainless steel 304, 316 and 316L. Optionally, the forward arm 10, 10’, 10’’ comprises of flexible material (allowing the pulling of the cannula in various angles (between the forward arm and the cannula)). This assists in preventing the hand of the user clinician to be blocked by the patient’s hand, and enables the user to pull at a higher angel. These elements herein are constructed / manufactured via conventional means, e.g., mold formation, machining, etc.

[0121] The IV catheter cannula 2 diameter is preferably between 0.5mm to 2mm, and length preferably between 4- 15cm, most preferably 8cm. The sizes of the wings, cannula hub, end portion and valve are such as in standard existing catheters.

[0122] The safety capsule 6, 6’ may (alternatively or in addition to the materials indicated herein) comprises material from the group consisting of steel, titanium and a polymer. A commercial example of such capsule 6 is Healcath™ Passive Safety Straight IV Cannula. Another commercial example is ECOCANN S: Safety IV Cannula.

[0123] The sizes of the catheter system known elements, e.g., the cannula, hubs, needle, wings, safety capsule are preferably according to the sizes of standard used similar elements as known in the art (according to several size variations known in the art). Other elements, such as the frame, forward arm, fingers grip, plates, may be of various sizes, for example, sizes as shown in the figures relative to the known catheter system elements that appear in the figures. However, it should be understood that these other elements may vary in size (length, width, thickness, height, diameter) which are not necessarily bounded to such as they appear in the figures.

[0124] The present invention also relates to a method for insertion of an IV catheter into a blood vessel of a patient in connection with the device explained hereinabove in accordance with all the embodiments (and all combinations thereof). Portions of the method were explained hereinabove.

[0125] The present invention relates to a method for inserting an IV catheter into a blood vessel of a patient. The method further comprises steps as explained herein with regard to the present invention system. The present invention method comprises the steps of:

[0126] A) providing a forward arm (e.g. 10) connected to a safety capsule (6) that is connected to a proximal cannula hub (5) of said IV catheter (1), said forward arm extending distally therefrom;

[0127] B) providing a catheter insertion system fingers grip (20) interconnected to a needle (e.g. the needle hub connected to the frame) passing through said IV catheter;

[0128] C) grasping the fingers grip by means of a user’s fingers (e.g. a thumb at one end and the middle finger at the other end);

[0129] D) puncturing the patient's blood vessel by means of moving the fingers grip distally;

[0130] E) advancing said forward arm distally thus inserting the cannula into the blood vessel until it is in place;

[0131] F) proximally retracting the fingers grip until the needle tip is encapsulated in the safety capsule (as explained herein);

[0132] G) maneuvering the fingers grip (which is interconnected to the needle and after the needle was encapsulated by the safety capsule, the fingers grip is also interconnected to the safety capsule and thus to the forward arm) proximally until the needle, the safety capsule and the forward arm are removed away from the catheter (and typically disposed of); H) releasing the grasp of the fingers grip.

[0133] I) fixing the IV catheter to the patient's skin.

[0134] In some embodiments, step E comprises: providing that the forward arm comprises a plurality of spaced apart tabs (11, Ila) on its top, advancing said forward arm distally by means of periodically distally pushing (e.g. by means of the index finger) a respective tab of said tabs (as explained herein).

[0135] According to another embodiment, the present invention method comprises the steps of:

[0136] A) providing a forward arm (e.g. 10) connected to a catheter proximal cannula hub (5) or other element that is connected to said IV catheter (1), said forward arm extending distally therefrom;

[0137] B) providing a catheter insertion system fingers grip (20) interconnected to a needle (e.g. the needle hub connected to the frame) passing through said IV catheter;

[0138] C) grasping the fingers grip by means of a user’s fingers (e.g. a thumb at one end and the middle finger at the other end);

[0139] D) puncturing the patient's blood vessel by means of moving the fingers grip distally;

[0140] E) advancing said forward arm distally thus inserting the cannula into the blood vessel until it is in place;

[0141] F) proximally retracting the fingers grip until the needle tip proximally passes the catheter hub or other element that is connected to said IV catheter and is removed away from the catheter;

[0142] G) releasing the grasp of the fingers grip;

[0143] H) disconnecting and removing the forward arm from the catheter hub or from the other element that is connected to said IV catheter;

[0144] I) fixing the IV catheter to the patient's skin.

[0145] In some embodiments, step E comprises: providing that the forward arm comprises a plurality of spaced apart tabs (11, Ila) on its top, advancing said forward arm distally by means of periodically distally pushing (e.g. by means of the index finger) a respective tab of said tabs (as explained herein).

[0146] The above examples and description have of course been provided only for the purpose of illustration, and are not intended to limit the invention in any way. As will be appreciated by the skilled person, the invention can be carried out in a great variety of ways, employing more than one technique from those described above, all without exceeding the scope of the invention.

Claims

CLAIMS1. A catheter insertion system comprising:- an IV catheter comprising a distal cannula attached to a proximal hollow cannula hub;- a forward arm interconnected to a proximal portion of said IV catheter or element connected thereto and extending distally therefrom;- a frame wherein the cannula passes from within said frame;- an unsplittable fingers grip placed at the distal end of said frame;- a needle configured to pass through and protrude from said cannula.

2. The catheter insertion system according to claim 1 , wherein the forward arm comprises a distal forward grip.

3. The catheter insertion system according to claim 2, wherein the distal forward grip extends upwards vertically from the distal end of the forward arm.

4. The catheter insertion system according to claim 1 , wherein the forward arm comprises a plurality of tabs extending upwards from the top of the forward arm.

5. The catheter insertion system according to claim 4, wherein the tabs are evenly spaced apart from one another.

6. The catheter insertion system according to claim 4, wherein the tabs are in the form of peaks each having a vertical proximal side.

7. The catheter insertion system according to claim 4, wherein the forward end of the fingers grip comprises a recess such that a most distal tab of the plurality of tabs is placeable within said recess.

8. The catheter insertion system according to claim 1, wherein the forward arm comprises a safety capsule connected at its bottom; wherein the safety capsule is connected to the proximal side of the catheter proximal cannula hub in a luer connection; wherein the needle passes through said safety capsule; and wherein said safety capsule is associated with a safety needle mechanism.

9. The catheter insertion system according to claim 1, wherein the frame is in the form of an elongated straight hollow tube.

10. The catheter insertion system according to claim 9, wherein the frame comprises a top slot along its length.

11. The catheter insertion system according to claim 10, comprising a splitable distal tube placed distal to the frame.

12. The catheter insertion system according to claim 11, wherein the fingers grip element comprises a first side plate and a second side plate; wherein the splitable distal tube comprises a first half tube connected to a first side arm which is connected to the distal portion of said first side plate; wherein the splitable distal tube comprises a second half tube connected to a second side arm which is connected to the distal portion of said second side plate; wherein the first side arm is connected to the first side plate by means of a hinge joint; and wherein the second side arm is connected to the second side plate by means of a hinge joint.

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

14. The catheter insertion system according to claim 1, wherein the fingers grip element comprises two substantially diagonal side plates.

15. The catheter insertion system according to claim 14, wherein the fingers grip element plates are curved in a convex manner.

16. The catheter insertion system according to claim 14, wherein each side plate comprises a plurality of slots and / or a plurality of apertures.

17. The catheter insertion system according to claim 1, further comprising a blood stop element placeable within the cannula hub via its proximal end; wherein the blood stop element comprises: a distal cylindrical stopper member placeable within the cannula hub; two side arms extending proximally from the blood cylindrical stopper member; and two side flaps, each extending proximally from a respective side arm of the two side arms; wherein at least said distal cylindrical stopper member comprises soft material.

18. The catheter insertion system according to claim 17, wherein the forward arm comprises a safety capsule connected at its bottom; wherein the safety capsule is connected to the proximal side of the catheter proximal cannula hub in a luer connection; wherein the needle passes through said safety capsule; and wherein said safety capsule is associated with a safety needle mechanism; wherein the side flaps extend proximally out of the catheter hub; and wherein the safety capsule comprises two side recesses wherein each flap is inserted within a respective recess of said recesses.

19. The catheter insertion system according to claim 1, wherein the forward arm comprises a plurality of spaced apart folding slots placed along the bottom of the forward arm.

20. The catheter insertion system according to claim 1, wherein the frame geometry is unchangeable.

21. The catheter insertion system according to claim 1, wherein the fingers grip geometry is unchangeable.

22. The catheter insertion system according to claim 1. wherein the fingers grip is a single operating point.

23. The catheter insertion system according to claim 1, wherein the catheter further comprises side wings; wherein the frame comprises two side arms attached at their proximal ends to a mount connected to a needle hub and connected at their distal ends to the fingers grip element.

24. A method for inserting an IV catheter into a blood vessel of a patient comprising the steps of:A) providing a forward arm connected to a safety capsule that is connected to a proximal hub of said IV catheter, said forward arm extending distally therefrom;B) providing a catheter insertion system fingers grip interconnected to a needle passing through said IV catheter;C) grasping the fingers grip by means of a user’s fingers;D) puncturing the patient's blood vessel by means of moving the fingers grip distally;E) advancing said forward arm distally thus inserting the cannula into the blood vessel until it is in place;F) proximally retracting the fingers grip until the needle tip is encapsulated in the safety capsule;G) maneuvering the fingers grip proximally until the needle, the safety capsule and the forward arm are removed away from the catheter;H) releasing the grasp of the fingers grip.I) fixing the IV catheter to the patient's skin.

25. The method according to claim 24, wherein step E comprises: providing that the forward arm comprises a plurality of spaced apart tabs on its top, advancing said forward arm distally by means of periodically distally pushing a respective tab of said tabs.

26. A method for inserting an IV catheter into a blood vessel of a patient comprising the steps of:A) providing a forward arm connected to a catheter proximal hub or other element that is connected to said IV catheter, said forward arm extending distally therefrom;B) providing a catheter insertion system fingers grip interconnected to a needle passing through said IV catheter;C) grasping the fingers grip by means of a user’s fingers;D) puncturing the patient's blood vessel by means of moving the fingers grip distally;E) advancing said forward arm distally thus inserting the cannula into the blood vessel until it is in place;F) proximally retracting the fingers grip until the needle tip proximally passes the catheter hub or other element that is connected to said IV catheter and is removed away from the catheter;G) releasing the grasp of the fingers grip;H) disconnecting and removing the forward arm from the catheter hub or from the other element that is connected to said IV catheter;I) fixing the IV catheter to the patient's skin.

27. The method according to claim 26, wherein step E comprises: providing that the forward arm comprises a plurality of spaced apart tabs on its top, advancing said forward arm distally by means of periodically distally pushing a respective tab of said tabs.

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