Catheter insertion device

Abstract

A tool for inserting a catheter into a patient is provided. The tool comprises: a housing in which at least a portion of the conduit is initially disposed; a needle extending distally from the housing, at least a portion of the catheter disposed on the needle; a guidewire initially partially disposed within the needle; and an advancement assembly for distally advancing the catheter. The housing includes: a first portion including a distal portion and a proximal portion; and a second portion engaged with the first portion; wherein the distal portion of the first portion is configured to slide distally relative to the second portion to release engagement between the first portion and the second portion. The advancement assembly includes a helmet initially disposed over the needle and configured to lock to the housing when sliding distally to a position that isolates the tip of the needle within the helmet.

Description

[0001] Case information

[0002] This application is a divisional application of the invention patent application with application number 202111592246.9 filed on April 27, 2017 and invention name “Catheter Insertion Device”, which is a divisional application of the invention patent application with application number 201710288072.4 filed on April 27, 2017 and invention name “Catheter Insertion Device”. Technical Field

[0003] The present invention relates to medical devices, and more particularly, to a catheter insertion device for inserting a catheter into a patient's body. Summary of the invention

[0004] Embodiments of the present invention relate to an insertion tool for inserting a catheter or other tubular medical device into a patient's body. In one embodiment, the insertion tool integrates a needle inserter, a guidewire pusher, a needle extending distally from a housing, and a catheter inserter in a single device to provide a catheter placement process.

[0005] In one embodiment, the catheter insertion tool of the present invention includes a housing, a safety cap slidable along a needle, wherein the safety cap is configured to be locked to the housing when slid distally to a position isolating the tip of the needle within the safety cap.

[0006] In one embodiment, the safety cap includes a first portion enclosing the needle and a second portion slidably attached to a guide rail, the guide rail being an integral part of the housing or fixed to the housing. In an optional embodiment, the catheter insertion tool also includes a catheter sleeve, which is connected to the safety cap until it is locked to the housing when the safety cap is slid distally to a position that isolates the tip of the needle.

[0007] In one embodiment, the housing of the catheter insertion tool of the present invention includes a first part having a distal portion and a proximal portion and a second part engaged with the first part, wherein the distal portion of the first part is configured to be able to slide distally relative to the second part to release the engagement between the first part and the second part.

[0008] In an alternative embodiment, the proximal portion of the first part of the housing is fixed to the second part. In an alternative embodiment, a hook is provided on the inner surface of the distal portion of the first part, the hook having a tip extending toward the proximal end of the housing, and a slot is provided on the second part of the housing, wherein the slot receives the hook when the first and second parts are engaged, and the hook is released from the slot when the distal portion of the first part slides distally, so that the first part is released from the second part.

[0009] In an optional embodiment, the proximal end of the distal portion of the first part of the housing is configured to be axially locked to the second part of the housing, and the distal portion of the first part is configured to be able to slide distally relative to the second part when the lock between the proximal end of the distal portion of the first part and the second part is released so as to release the engagement between the first part and the second part. In an optional embodiment, the proximal end of the distal portion of the first part is flexible and is biased toward the second part when the proximal end of the distal portion of the first part is axially locked to the second part. In an optional embodiment, the proximal end of the distal portion of the first part is biased toward the second part by a slider, and wherein when the slider is moved distally to a specific position, the proximal end of the distal portion of the first part is not biased, and the lock between the proximal end of the distal portion of the first part and the second part is released.

[0010] In an optional embodiment, the first protrusion extends from the proximal end of the distal portion toward the second portion of the shell, and the second protrusion extends from the second portion to the proximal end of the distal portion of the first portion of the shell, and when the proximal end of the distal portion of the first portion is biased toward the second portion and the first protrusion is proximal relative to the second protrusion, the proximal end of the distal portion of the first portion is axially locked to the second portion.

[0011] In one embodiment, the barrier of the catheter insertion tool of the present invention includes a cylindrical body and a first protrusion extending from a central portion of a top surface of the body.

[0012] In an optional embodiment, the barrier of the present invention further comprises a slit formed in the barrier along the longitudinal axis of the barrier. Optionally, the slit is formed in the first protrusion. Optionally, the slit extends through the barrier. Optionally, the slit is enlarged when the needle extends through the slit, and the slit is closed when the needle is withdrawn from the barrier. Optionally, the outer diameter of the body of the barrier is greater than the inner diameter of the lumen of the catheter insertion tool before the barrier is installed in the lumen. In an optional embodiment, the barrier of the present invention further comprises a second protrusion extending from a central portion of the bottom surface of the body opposite the top surface.

[0013] In one embodiment, a barrier for a catheter insertion tool of the present invention comprises: a circular end and a tubular portion extending from the periphery of the circular end. In an optional embodiment, the barrier of the present invention further comprises a protrusion extending from the central portion of the surface of the circular end opposite to the tubular portion. Optionally, a slit is formed in the end. Optionally, the slit is formed in the protrusion. Optionally, the slit extends through the end. Optionally, the slit is enlarged when the needle extends through the slit; and the slit is closed when the needle is withdrawn.

[0014] In one embodiment, the guidewire advancing device for the catheter insertion tool of the present invention comprises: a push block, comprising a hole extending through the push block from the top surface to the bottom surface of the push block, wherein the first side wall of the hole is in the form of a flat curve; and a guide rail, which comprises a groove aligned with the hole in the longitudinal direction of the catheter insertion tool. In an optional embodiment, the hole has a second side wall opposite to the first side wall, the second side wall is straight, and the minimum distance between the first side wall and the second side wall is wide enough to allow free longitudinal movement of the guide wire and narrow enough to limit the swing of the guide wire.

[0015] In an optional embodiment, the guidewire advancement device further comprises an anchor point, one end of the guidewire is fixed to the anchor point, and the guidewire extends proximally from the anchor point, enters the hole through the first portion of the guide rail, extends out of the hole and extends distally into the second portion of the guide rail.

[0016] In one embodiment, the guidewire advancement device for the catheter insertion tool of the present invention comprises: a wheel and a rack, the rack being configured to rotate the wheel so that the guidewire is driven around the wheel. Optionally, the guidewire advancement device also includes a gear coaxially fixed to the wheel, wherein the rack includes teeth engaged with the gear. Optionally, the guidewire advancement device also includes at least one idler wheel for limiting the guidewire to the peripheral surface of the wheel. Optionally, the guidewire advancement device also includes a tubular guide rail for guiding the movement of the guidewire.

[0017] In one embodiment, the insertion tool of the present invention includes: a housing in which at least a portion of the catheter is initially disposed; a needle extending distally from the housing, on which at least a portion of the catheter is disposed; and an advancement assembly for distally advancing the catheter. The housing includes: a first portion, which includes a distal portion and a proximal portion; and a second portion engaged with the first portion, wherein the distal portion of the first portion is configured to be able to slide distally relative to the second portion to release the engagement between the first portion and the second portion; and wherein the advancement assembly includes a safety cap, which is initially disposed on the needle and is configured to be locked to the housing when slid distally to a position that isolates the tip of the needle within the safety cap. In an optional embodiment, the engagement of the first and second portions of the housing is released to prepare for the safety cap to slide to a position that isolates the tip of the needle within the safety cap.

[0018] These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the embodiments of the invention as presented herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] A more detailed description of the present disclosure will be presented by reference to specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not to be considered as limiting the scope thereof. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0020] Figure 1 is a perspective view of an insertion tool according to one embodiment of the present invention;

[0021] Figure 2 yes Figure 1 a top view of a cross section of an insertion tool;

[0022] Figure 3A and 3B yes Figure 1 and Figure 2 Various exploded views of the insertion tool;

[0023] Figures 4A-4C is a side view of a housing of a catheter insertion tool according to one embodiment of the present invention;

[0024] Figure 4D Shows Figures 4A-4C the inner surface of the shell;

[0025] Figures 5A-5C is a side view of a housing of a catheter insertion tool according to one embodiment of the present invention;

[0026] Figure 5D-5F Shows Figures 5A-5C Various views of the housing;

[0027] Fig. 6A and 6B Various views showing the internal structure of an insertion tool according to one embodiment of the present invention;

[0028] Figure 6C The structure of the safety cap of the insertion tool according to one embodiment of the present invention is shown;

[0029] Fig. 7A and 7B illustrates the engagement between a catheter hub and a safety cap of an insertion tool according to one embodiment of the present invention;

[0030] Fig. 8A is a top view of a cross section of a safety cap and a guide rail of an insertion tool according to one embodiment of the present invention;

[0031] Figure 8B yes Fig. 8A A partial enlarged view of

[0032] Figure 8C yes Fig. 8Aand 8B A cross-sectional view of a hard hat;

[0033] Fig. 9 A barrier member provided in an insertion tool according to an embodiment of the present invention is shown;

[0034] Figures 10A-10D Various views showing a barrier according to one embodiment of the present invention;

[0035] Fig.11A and 11B Various views showing a barrier according to one embodiment of the present invention;

[0036] Fig. 12A and 12B Various views of a guidewire advancement assembly according to one embodiment of the present invention are shown;

[0037] Figures 13A-13C Various views of a guidewire pusher according to one embodiment of the present invention are shown;

[0038] Fig.14A and 14B Various views of a guidewire advancement assembly are shown in accordance with one embodiment of the present invention. DETAILED DESCRIPTION

[0039] Reference will now be made to the drawings, wherein like structures will be provided with like reference numerals. It should be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither restrictive nor necessarily drawn to scale.

[0040] For the sake of clarity, it should be understood that the word "near" refers to the direction relatively closer to the clinician using the device to be described herein, and the word "far" refers to the direction relatively farther from the clinician. For example, the end of the catheter placed in the patient's body is considered to be the distal end of the catheter, and the end of the catheter retained outside the body is the proximal end of the catheter. In addition, including the claims, the words "comprising", "having" and "having" used herein should have the same meaning as "including". Unless otherwise expressly stated, the term "initial" refers to a state in which the insertion tool of the present invention is delivered to a medical institution such as a hospital or clinic (or delivered to a patient for use by the patient himself or the patient's personal care assistant) while still in an assembled state, and is not operated or used. Unless otherwise stated, "axial" or "axially" refers to the longitudinal direction of the insertion tool, which is also the orientation of the needle.

[0041] Embodiments of the present invention generally relate to a kind of instrument that is used to assist catheter or other tubular medical device to be placed in patient's body.For example, catheter of various lengths is usually placed in patient's body, so that the access of entering patient's vascular system is established, and can infuse medicine or inhale body fluid.The catheter insertion tool to be described here is convenient for this catheter to be placed.It should be noted that, although the discussion below focuses on the placement of catheter of specific type and relatively short length, catheter of various types, sizes and lengths can be inserted by this device, including peripheral IV intermediate or expansibility indwelling catheter, PICC catheter, central venous catheter etc.In one embodiment, it is possible to have catheter of any length.

[0042] First reference Figure 1 and Figure 2 , Figure 1 and Figure 2 Various details of a catheter insertion tool, generally depicted at 10 (hereinafter also referred to as an "insertion tool"), are depicted according to one embodiment. Figure 1 As shown, it is a perspective view of the insertion tool. The insertion tool 10 includes a housing 12, and the housing 12 includes a first part 12A and a second part 12B.

[0043] In one embodiment, the first portion 12A of the housing 12 is detachably engaged with the second portion 12B of the housing 12. In one embodiment, the first portion 12A can slide distally relative to the second portion 12B to release the engagement. Details on engagement and release will be provided later.

[0044] Figure 2 is a top view of a cross section of an insertion tool. Figure 2 As shown, the insertion tool 10 includes a guide rail 14, which is an integral part of the housing 12, or a separate component but fixed to the housing 12. For example, the guide rail 14 can be a first portion 12A of the housing 12 (such as Figure 1 As shown) or an integral part of the second portion 12B of the housing 12, or is fixed to the housing 12 by molding or assembly.

[0045] The insertion tool 10 also includes a handle 16 for the clinician to stably hold the tool 10 while operating the tool. In one embodiment, the handle 16 extends from the guide rail 14. In other embodiments, the handle 16 extends from the housing 12, wherein the handle is disposed on the first portion 12A or the second portion 12B of the housing 12. In one embodiment, one surface of the handle 16 includes small protrusions to increase friction. In another embodiment, the surface of the handle 16 includes other structures that can increase friction, such as grooves, streaks, frosted surfaces, etc. When a user such as a clinician operates the insertion tool, such protrusions or similar structures on the surface of the handle 16 improve operational stability.

[0046] Figure 3A and Figure 3B yes Figure 1 and Figure 2 Various exploded views of the insertion tool 10. Now refer to Figure 3A , wherein a needle hub 18A supporting a hollow needle 18 is placed between housing portions 12A and 12B. Needle 18 extends distally from needle hub 18A, passes through the body of insertion tool 10 and exits the distal end of housing 12. In other embodiments, needle 18 is at least partially hollow while still being able to perform the functions described herein. In one embodiment, a notch 18B is defined through the wall of needle 18 near the distal end of needle 18. Once the patient's vascular system is entered during the catheterization process, notch 18B enables flashback of blood to leave the lumen defined by hollow needle 18. Therefore, blood leaving notch 18B can be observed by a clinician to confirm that the needle is properly inserted into the vascular system.

[0047] like Figure 2 and 3B As shown, the insertion tool 10 also includes a catheter advancement assembly 20 for advancing a catheter 22 distally into the vascular system of a patient. The proximal end of the catheter 22 is connected to a catheter sleeve 24. Both the catheter 22 and the catheter sleeve 24 are initially arranged on the needle 18. At least a portion of the catheter 22 and the catheter sleeve 24 are pre-arranged in the housing 12. In one embodiment, the distal portion of the catheter 22 extends out of the distal end of the housing 12. In one embodiment, the catheter sleeve 24 includes a handle extending from the groove 12C on the housing 12, and the handle of the catheter sleeve 24 can be used to achieve the advancement of the catheter 22 and the catheter sleeve 24. The groove 12C exists between the first part 12A and the second part 12B of the housing 12, allowing the movement of the handle of the catheter sleeve 24. In another embodiment, the handle of the catheter sleeve 24 is a branch pipe 24A extending from the catheter sleeve 24. In another embodiment, sterile protection is provided to the branch pipe.

[0048] Continue to refer Figure 2 and Figure 3B , wherein the insertion tool 10 includes a safety cap 26. The safety cap 26 is initially attached to the catheter sleeve 24 and can be separated from the catheter sleeve 24 when it slides distally to a certain position. In one embodiment, when sliding to this position, the safety cap 26 is locked to the housing 12. The details of the locking mechanism will be described below.

[0049] In one embodiment, the safety cap 26 includes a first portion 26A that encloses the needle and a second portion 26B that is slidably attached to the guide rail 14. In one embodiment, the position in which the catheter sleeve 24 and the safety cap 26 are separable is a position in which the tip of the needle 18 is isolated within the first portion 26A of the safety cap 26. In one embodiment, when the safety cap 26 slides to a position in which the tip of the needle 18 is isolated within the first portion 26A of the safety cap 26, the second portion 26B of the safety cap 26 is locked to the guide rail 14. The locking between the safety cap 26 (more specifically the second portion 26B) and the guide rail 14 prevents relative movement between the safety cap 26 and the needle 18, avoids re-exposure of the tip of the needle, and thereby eliminates the possibility of a needle stick to the clinician or patient.

[0050] refer to Figure 3B In one embodiment, the insertion tool 10 also includes at least one barrier 28 to prevent blood exposure when the needle and catheter are inserted into or removed from the patient. One or more barriers can be placed in the insertion tool 10. In one embodiment, the barrier 28 is disposed in the lumen of the catheter sleeve 24. In one embodiment, the barrier 28 is disposed on the first part 26A of the safety cap 26. In one embodiment, the barrier 28 is disposed in the lumen of the first part 26A of the safety cap 26. It should be noted that the barrier can also be disposed in other elements of the insertion tool, for example, the branch tube of the catheter sleeve 24. The size and shape of the barrier are configured to match the corresponding element or the lumen of the element, and when multiple barrier members are used, the size and shape of each barrier member can be the same or different.

[0051] Return to reference Figure 3A In one embodiment, the insertion tool 10 includes a guidewire advancement assembly 30 for advancing a guidewire 32 distally into or withdrawing it from the patient's vascular system. In one embodiment, the guidewire advancement assembly 30 also includes a pusher 34 for operating the movement of the guidewire 32 to prepare for advancement of the catheter 22.

[0052] In one embodiment, at least a portion of the guide wire 32 is disposed in the lumen of the needle 18. In an optional embodiment, the distal end of the guide wire 32 is initially disposed in the tip of the needle 18, and the other end of the guide wire 32 is fixed to an anchor point on the housing 12 or the guide rail 14. The guide wire 32 extends proximally from the anchor point, enters a hole 36 disposed on the pusher 34 and is bent by the hole 36, extends away from the hole 36 and extends distally into the lumen of the needle 18. In one embodiment, the movement of the pusher 34 applies frictional force on the curved portion of the guide wire 32 so as to advance or retract the distal portion of the guide wire. When the pusher 34 moves distally, the guide wire 32 is advanced distally by twice the distance of the movement of the pusher 34. This conveniently improves the efficiency of the guide wire advancement, which is desirable in the operation of such a medical device.

[0053] case

[0054] Figure 4A and Figure 4B 4 is a side view of the housing 40 of the catheter insertion tool of the present invention. The housing 40 includes a first portion 42 and a second portion 44 engaged with the first portion 42, the first portion 42 includes a distal portion 42A and a proximal portion 42B, wherein the distal portion 42A of the first portion 42 is configured to be able to slide distally relative to the second portion 44 to release the engagement 46 between the first portion 42 and the second portion 44.

[0055] In one embodiment, the proximal portion 42B of the first portion 42 is fixed to the second portion 44. Optionally, the proximal portion 42B of the first portion 42 is engaged with the second portion 44 via a detachable structure, such as a snap joint, a pin joint, a rivet joint, a buckle, etc. A force exceeding a threshold magnitude is required to release the detachable engagement between the proximal portion 42B of the first portion 42 and the second portion 44 to prevent accidental separation of the housing. In other embodiments, the proximal portion 42B of the first portion 42 and the second portion 44 are inseparable from each other or form a single piece.

[0056] In one embodiment, Figure 4C and Figure 4D As shown, a hook 46A is provided on the inner surface of the distal portion 42A of the first part 42 of the housing. The hook 46A has a tip extending toward the proximal end of the housing 40. A slot 46B is provided on the second part 44. When the first part 42 and the second part 44 are engaged, the slot 46B receives the hook 46A, and when the distal portion 42A of the first part 42 slides distally so that the first part 42 is released from the second part 44, the hook 46A is released from the slot 46B.

[0057] Back to Figure 4A , the first part 42 and the second part 44 of the housing 40 are engaged with each other through the engagement 46 formed by the hook 46A and the groove 46B and the engagement between the proximal part 42B of the first part 42 and the second part 44. In the direction indicated by the arrow, the distal part 42A of the first part 42 can slide distally relative to the second part 44 of the housing 40. The distal sliding of the distal part 42A of the first part 42 causes the hook 46A to move distally relative to the groove 46B. When the tip of the hook 46A reaches the distal end of the groove 46B, the hook 46A is moved to the distal end of the groove 46B. Figure 4B In the illustrated position, the hook 46A can be disengaged from the slot 46B such that the engagement 46 is released and the distal portion 42A of the first portion 42 and the second portion 44 can be separated in a perpendicular direction relative to each other.

[0058] It should be noted that although Figures 4A-4DOnly one pair of hooks 46A and slots 46B is shown, but in one embodiment, the housing 40 of the present invention includes two hooks and two slots. In order to better stabilize the joint 46, as a preferred embodiment, two hooks are arranged in parallel on the inner surface of the distal portion 42A, and correspondingly, two slots are provided on the second portion 44 in the same manner as the two hooks. Other numbers and arrangements of hooks and slots are possible within the spirit of the present invention.

[0059] like Figure 4A and 4B As shown, in one embodiment, a base 48 is disposed on the inner surface of the second portion 44 of the housing 40 for holding the proximal end of the needle 18. The proximal end of the needle 18 is fixed to the housing. In one embodiment, the base 48 includes a hole to allow a guide wire to extend into the lumen of the needle 18 via the hole.

[0060] like Figure 4D As shown, in one embodiment, a groove 45 is provided on the inner surface of at least one of the first and second parts 42 / 44, and the inner width of the groove 45 is wide enough to allow the catheter to move freely in the axial direction, and is narrow enough to limit the movement of the catheter perpendicular to the axial direction. That is, when engaged with each other, the first and second parts of the housing provide support for the distal portion of the needle 18, which limits the swing of the needle 18 when the needle 18 is inserted into or withdrawn from the patient's body.

[0061] In one embodiment, the distal portion 42A and the proximal portion 42B are always connected to each other before or after the distal movement of the distal portion 42A. The connection can be formed by an elastic or foldable or hinged connection. An example of an elastic or foldable connection can be a hinge, a spring or other flexible member.

[0062] In other embodiments, the distal portion 42A of the first portion 42 may be separated from the second portion 44 after the distal portion is slid distally to release the engagement between the first portion 42 and the second portion 44 .

[0063] Continuous reference Figures 4A-4DIn another embodiment, the proximal end of the distal portion 42A of the first part 42 includes a structure 49 sandwiched between the proximal portion 42B of the first part 42 and the second portion 44, and the movement of the structure 49 is restricted in the cavity formed by the proximal portion 42B and the second portion 44 of the first part 42. Specifically, in one embodiment, the structure 49 includes a flexible sheet 49A extending proximally from the proximal end of the distal portion 42A and two walls 49B extending vertically from both sides of the end of the flexible sheet 49A. In one embodiment, after the distal portion 42A slides distally for a certain distance, the structure 49 is blocked by the base 48 to prevent further distal movement of the distal portion 42A of the first part 42. The certain distance is also the distal movement distance of the hook 46A that allows the hook 46A to be released from the groove 46B.

[0064] In one embodiment, the tab 49A and two walls 49B of the structure 49 of the distal portion 42A engage a ridge extending from the base 48. The ridge acts as a guide for the structure 49, allowing distal movement along the ridge, but also limiting rocking of the structure 49 during distal movement.

[0065] In one embodiment, the structure 49 is clamped by the base 48 of the second part 44 and the inner surface of the proximal portion 42B of the first part 42. This prevents the distal portion 42A from being separated from the rest of the shell, and allows the distal portion 42A to open and close at a certain angle relative to the second part 44. Such a mechanism prevents the shell from falling off after use, which is beneficial to medical safety (e.g., preventing needle sticks and / or blood contamination) and user experience.

[0066] Figures 5A-5C is a side view of the housing 50 of the catheter insertion tool of the present invention. Figure 5A As shown, the housing 50 includes a first portion 52 and a second portion 54 joined to the first portion 52, wherein the first portion 52 includes a distal portion 52A and a distal portion 52A similar to Figure 4A and 4B The proximal portion of the proximal portion 42B shown. The proximal end 56 of the distal portion 52A of the first portion 52 is configured to be axially locked to the second portion 54, and the distal portion 52A of the first portion 52 is configured to be able to slide distally relative to the second portion 54 when the lock between the proximal end 56 of the distal portion 52A of the first portion 52 and the second portion 54 is released, so as to release the engagement 46 between the first portion 52 and the second portion 54.

[0067] Continue to refer Figure 5A , wherein in one embodiment, as shown in the partially enlarged view “A”, the first protrusion 56A extends from the proximal end 56 of the distal portion 52A toward the second portion 54, and the second protrusion 56B extends from the second portion 54 toward the proximal end 56 of the distal portion 52A of the first portion 52. Figure 5A In the embodiment, the proximal end 56 of the distal portion 52A of the first portion 52 is flexible and biased toward the second portion 54 (for example, by the slider 58), and the first protrusion 56A is proximal relative to the second protrusion 56B, whereby the proximal end 56 of the distal portion 52A of the first portion 52 is axially locked to the second portion 54, so that the first portion 52 cannot move axially and distally relative to the second portion 54.

[0068] Figure 5B yes Figure 5A A side view of the distal portion 52A of the first portion 52 of the housing is shown. Figure 5B The proximal end 56 of the distal portion 52A is shown in a natural, unbiased state and in the form of a ramp that is slightly inclined proximally and upwardly. The ramp can have a continuous thickness. Optionally, the thickness of the ramp can gradually increase or decrease distally, reaching a minimum or maximum thickness at the location of the first protrusion 56A (regardless of the height of the first protrusion 56A itself). This varying thickness of the ramp can help change the amount of force applied by the slider 58 to the ramp and the friction between the slider 58 and the ramp.

[0069] Figure 5C 5 is a side view of the housing 50 when the lock between the proximal end 56 of the distal portion 52A of the first part 52 and the second part 54 is released. In one embodiment, when the slider 58 moves distally, the force applied by the slider 58 on the proximal end 56 of the distal portion 52A of the first part 52 decreases, and the proximal end 56 is gradually unbiased, so that the first protrusion 56A moves upward relative to the second protrusion 56B. When the slider 58 moves distally as shown in FIG. Figure 5C In the particular position shown, the first protrusion 56A moves until reaching a position where the second protrusion 56B no longer blocks the distal movement of the first protrusion 56A, so the lock between the proximal end 56 of the distal portion 52A of the first part 52 and the second part 54 is released.

[0070] Similar to Figures 4A-4D The housing 40 in Figure 5D and 5E In one embodiment shown, the hook 46A is provided on the inner surface of the distal portion 52A of the first portion 52 of the housing 50, and the groove 46B is provided on the second portion 54 of the housing 50 at a position corresponding to the hook 46A. The hook 46A may be in a form that first protrudes vertically from the inner surface of the distal portion 52A of the first portion 52 of the housing 50 and then extends horizontally and proximally, as shown in FIG. Fig. 5FWhen the first part 52 and the second part 54 are engaged, the groove 46B receives the hook 46A, and when the lock between the proximal end 56 of the distal portion 52A of the first part 52 and the second part 54 is released and the distal portion 52A of the first part 52 slides distally, the hook 46A is released from the groove 46B, so that the first part 52 can be released from the second part 54.

[0071] Fig. 5F 5 is a side view of the insertion tool, showing the state when the engagement between the distal portion 52A of the first part 52 and the second part 54 is released. In one embodiment, the proximal end 56 of the distal portion 52A of the first part 52 includes a proximal portion ( Fig. 5F The structure 56C is provided between the first portion 52 and the second portion 54, and the movement of the structure 56C is restricted in the cavity formed by the proximal portion of the first portion 52 and the second portion 54. Specifically, in one embodiment, the structure 56C is similar to Figure 4A -C. In one embodiment, after the distal portion 52A slides distally a certain distance, the structure 56C is blocked by the base 48 to prevent further distal movement of the distal portion 52A of the first portion 52, wherein the certain distance is also the distal movement distance of the hook 46A that allows the hook 46A to be released from the groove 46B.

[0072] This locking mechanism between the proximal end 56 of the distal portion 52A of the first part 52 and the second part 54 can effectively prevent the clinician's inadvertent operation that may cause the distal movement of the distal portion of the first part of the housing, and thus prevent the undesired separation of the housing. In addition, in one embodiment, in addition to releasing the axial lock between the distal portion 52A of the first part 52 and the second part 54, the distal movement of the slider 58 is also configured to simultaneously advance the guidewire, and this configuration increases operational efficiency and safety.

[0073] Needle tip protection

[0074] Figure 2 and Fig. 6A 1 shows the internal structure of an embodiment of the insertion tool 10 of the present invention. Specifically, Figure 2 1 is a top view of the insertion tool 10 without the first portion 12A of the housing 12. In one embodiment, the insertion tool 10 of the present invention includes the housing 12, a guide rail 14 attached to the housing, a needle 18 extending distally from the housing 12, a catheter advancement assembly 20, and a guidewire advancement assembly 30, wherein the catheter advancement assembly 20 includes a catheter 22, a catheter sleeve 24, and a safety cap 26 detachably attached to the catheter sleeve 24.

[0075] Apart from Figure 2 In addition to the status shown, Fig. 6AThe safety cap 26 is shown slid distally to a position where the safety cap 26 is locked to the guide rail 14. In one embodiment, the safety cap 26 is configured to be locked to the housing 12 when slid distally to a position that isolates the tip of the needle 18 within the safety cap 26. It is noted that since the guide rail 14 can be part of the housing or attached to the housing, the safety cap 26 can also be considered to be locked to the housing 12 when it is locked to the guide rail 14. Fig. 6A The position in which the safety cap 26 is locked to the housing and the tip of the needle is isolated within the safety cap 26 is clearly shown. In this position, the relative movement between the safety cap 26 and the needle 18 is restricted to prevent the tip of the needle from being exposed again.

[0076] Figure 6B It shows that when the helmet 26 is in the Fig. 6A The position shown is a view in which the catheter sleeve 24 is separated from the safety cap 26 .

[0077] like Fig. 6A and 6B As shown, in one embodiment, when the safety cap 26 is slid to a position isolating the tip 18C of the needle 18 within the safety cap 26 , the safety cap 26 is locked to the housing 12 at position 60 and the tip 18C of the needle 18 is isolated within the safety cap 26 .

[0078] Figure 6C FIG. 2 shows the structure of a safety helmet 26 according to an embodiment of the present invention. The safety helmet 26 includes a first portion 26A and a second portion 26B. Figure 2 , Fig. 6A and Figure 6B To view, in one embodiment, the first portion 26A of the safety cap 26 encases the needle 18, and the second portion 26B of the safety cap 26 is slidably attached to the guide rail 14. Specifically, in one embodiment, the first portion 26A of the safety cap 26 includes a lumen 27 extending through the first portion 26A that contains and encases the needle 18.

[0079] In one embodiment, the first portion 26A of the safety cap 26 has two fingers 62. In one embodiment, the two fingers 62 have a slit between them that wraps around the needle 18. In another embodiment, three, four, or even more fingers are possible. In another embodiment, the fingers 62 are strip-shaped or column-shaped.

[0080] Fig. 7A and 7B The engagement between the catheter hub 24 and the safety cap 26 of one embodiment of the present invention is shown. The engagement is formed by inserting the protrusion 64 on the finger 62 into the recess 66 provided on the catheter hub 24.

[0081] refer to Fig. 7AIn one embodiment, the fingers 62 are configured to be radially biased toward the inner surface of the catheter hub 24 when the shaft of the needle 18 extends through the first portion 26A of the safety cap 26. That is, when the first portion 26A of the safety cap 26 wraps around the needle shaft, the fingers 62 are slightly biased / pressed outward by the needle 18. The radially biased fingers 62 insert their protrusions 64 into the recesses 66, and the pressure from the needle 18 helps to secure the insertion of the protrusions 64 into the recesses 66, thereby achieving engagement between the catheter hub 24 and the safety cap 26.

[0082] refer to Figure 7B In one embodiment, the fingers 62 are configured to release from the biased position when the safety cap 26 is slid distally to a position that isolates the tip of the needle 18. That is, when the pressure from the needle is lost, the fingers 62 converge toward the axis of the lumen of the catheter hub 24, and the protrusions 64 can be pulled out of the recesses 66, so that the catheter hub 24 can be separated from the safety cap 26.

[0083] refer to Fig. 7A In one embodiment, the finger 62 is configured to remain in the same position when the handle of the needle is extended through the first portion 26A of the safety cap 26 and when the safety cap 26 is slid distally to a position that isolates the tip of the needle. That is, the finger 62 remains in the same position and is not substantially biased regardless of the pressure from the needle 18. The outer diameter of the hollow cylinder formed by the finger does not change regardless of whether the needle is extended through the hollow cylinder. However, the pressure from the needle 18 facilitates the insertion between the protrusion 64 and the recess 66.

[0084] refer to Figure 7B In one embodiment, when pressure from the needle is lost, the fingers 62 remain in the same position as when biased / compressed by the needle 18. In this case, when the user of the insertion tool attempts to pull the safety cap 26 away from the catheter hub 24, the protrusion 64 is pulled out of the recess 66.

[0085] In one embodiment, each finger 62 includes a protrusion 64 and a corresponding number of recesses 66 are provided on the inner surface of the catheter hub. In one embodiment, each finger 62 may include one or more protrusions 64.

[0086] Reference now Figure 6C The proximal side of the projection 64 forms an obtuse angle relative to the surface of the finger 62 at the location of the proximal side extending from the finger 62. That is, the proximal side of the projection 64 is a bevel that allows the projection 64 to be pulled out of the recess 66 when the finger 62 is not biased / pressed by the needle 18.

[0087] refer to Fig. 8A-C, the second part 26B of the safety cap 26 is a rod 81, which slides along the guide rail 14. In one embodiment, the rod 81 includes two vertical walls 82 extending vertically from both sides of a surface 84 of the rod 81 facing the guide rail 14. Each of the two vertical walls 82 has a horizontal portion, which has a protrusion 86, which is locked in a notch 88 formed on the guide rail 14 when the safety cap 26 slides distally to a position that isolates the tip of the needle 18 in the safety cap 26, so as to lock the safety cap 26 to the housing 12.

[0088] In order to clearly illustrate the structure of the rod 81, refer to Figure 8C , Figure 8C 8 is a cross-sectional view of a plane perpendicular to the axis of the lumen of the safety helmet 26. In one embodiment, the surface 84 of the rod facing the guide rail 14 includes two vertical walls 82, and the rod 81 is connected to the first portion 26A of the safety helmet 26 on the opposite side of the surface 84. Each of the two vertical walls 82 has a horizontal portion, which has a protrusion 86. Here, the horizontal portion is substantially parallel to the surface 84, and in one embodiment, the vertical wall 82 extends over the entire length of the rod, and the horizontal portion is shorter than the entire length of the rod. In another embodiment, the vertical wall 82 extends only over a portion of the length of the rod, and the horizontal portion is shorter than the length of the vertical wall 82.

[0089] like Figure 8B As shown, in one embodiment, the notch 88 is formed between two protruding protrusions 88A and 88B provided on the guide rail. In another embodiment, the protrusion 88A on the proximal side has an inclined slope 88C on the proximal side and is substantially perpendicular to the surface of the guide rail on the distal side. In one embodiment, the distal protrusion 88B rises higher from the surface of the guide rail 14 than the proximal protrusion 88A. When the protrusion 86 slides on the inclined slope 88C of the proximal protrusion 88A, the distance between the two protrusions 86 of the rod increases along the inclined slope 88C, and the tension between the two protrusions 86 also gradually increases. When the protrusion 86 falls into the notch formed by the protruding protrusions 88A and 88B, the further movement of the protrusion 86 is blocked by the proximal side of the protruding protrusion 88B and the distal side of the protruding protrusion 88A, so the safety helmet 26 is locked on the guide rail 14.

[0090] In one embodiment, a user of the insertion tool (eg, a clinician) feels a tactile sensation when the safety cap 26 is locked to the housing 12, such as when the protrusion 86 of the rod falls into the notch 88. In one embodiment, an audible sound is produced in addition to the tactile sensation.

[0091] Partition

[0092] refer to Fig. 9In one embodiment, the insertion tool includes at least one barrier 90 to prevent blood exposure when the needle is inserted and the catheter is advanced or removed from the patient's body. In one embodiment, the barrier 90 can be disposed in a lumen within the insertion tool. For example, the barrier 90 can be placed in the lumen of the catheter sleeve 24 of the insertion tool, and / or can be placed in the lumen of the safety cap 26 of the insertion tool.

[0093] In one embodiment, barrier 90 is disposed within the lumen of catheter sheath 24. In one embodiment, barrier 100 is disposed in first portion 26A of safety cap 26. In one embodiment, barrier 110 is disposed within the lumen of first portion 26A of safety cap 26. It should be noted that barrier may also be disposed in other elements of the insertion tool, such as a branch tube of catheter sheath 24. The size and shape of barrier 26 are configured to fit the corresponding element or lumen of the element, and the size and shape of each barrier may be the same or different.

[0094] Fig. 10A -D shows a barrier 90 according to an embodiment of the present invention. Fig. 10A In one embodiment, the barrier 90 includes a cylindrical body 92 and a first protrusion 94 extending from a central portion of a top surface 94A of the body 92. In one embodiment, the thickness of the cylindrical body 92 is configured to be smaller than the distance between the tip of the needle 18 and the recess so as to reduce friction between the barrier 90 and the needle 18.

[0095] like Fig. 10B As shown, the barrier 90 has a slit 96 formed in the barrier 90 along the longitudinal axis of the barrier. In one embodiment, the slit 96 is formed in the first protrusion. In one embodiment, the slit 96 extends through the barrier. Specifically, the slit 96 can extend partially or completely through the cylindrical body 92 and the protrusion. In one embodiment, when the needle 18 extends through the slit 96, the slit 96 is enlarged, and when the needle 18 is withdrawn from the barrier 90, the slit 96 is closed. When the needle pierces the entire barrier, the slit 96 thus extends through the barrier. As a preferred embodiment, in order to ensure the sealing performance of the barrier 90, the slit 96 initially does not pass through the entire thickness of the barrier 90, so when the needle pierces the barrier 90 during assembly, the barrier 90 will tightly wrap the needle and provide a tight seal around the needle. As another example, the septum 90 is formed without a slit therethrough, and when a needle pierces the septum 90, the septum 90 tightly wraps around the needle and can provide a tighter seal around the needle than a configuration with a slit (assuming the configuration is the same in all other respects).

[0096] In one embodiment, before the septum 90 is installed in the lumen of the catheter insertion tool, the outer diameter of the body 92 of the septum 90 is slightly larger than the inner diameter of the lumen. Specifically, the outer diameter of the body 92 of the septum 90 is larger than the inner diameter of the catheter sheath 24. When the septum 90 is assembled in the lumen of the catheter sheath 24, the inner surface of the catheter sheath 24 is in close contact with the septum 90, thereby providing a better seal.

[0097] In one embodiment, the first protrusion 94 of the barrier is in the form of a circular frustum tapering from the top surface 94A of the main body 92, such as Fig. 10B And the circular frustum is coaxial with the main body 92. In one embodiment, the first protrusion 94 is integral with the main body 92.

[0098] In one embodiment, the top surface 94A of the barrier 90 is rounded at the periphery. In one embodiment, the top surface of the circular frustum is rounded at the periphery.

[0099] In one embodiment, the barrier member 90 of the present invention further includes a second protrusion 98 extending from a central portion of a bottom surface 98A of the body 92 opposite to the top surface 94A.

[0100] In one embodiment, Fig. 10A and 10B As shown, the second protrusion 98 is in the form of a circular truncated cone that tapers from the bottom surface 98A. And the circular truncated cone is coaxial with the main body 92. In one embodiment, the second protrusion 98 is integral with the main body 92 and forms a whole. In another embodiment, the second protrusion 98 is in the form of a cylinder embedded in the center of the main body 92. In another embodiment, the first protrusion 94 and the second protrusion 98 form a cylinder embedded in the center of the main body 92. In one embodiment, the slit 96 extends partially in the cylinder formed by the first protrusion 94 or the second protrusion 98. In another embodiment, the slit 96 extends on the entire cylinder.

[0101] In one embodiment, the first and second protrusions are of the same size and shape. In another embodiment, the second protrusion 98 is lower than the first protrusion 94. When the lumen of the catheter sheath 24 is filled with fluid (e.g., blood) on one side of the septum 90, the side surface of the first or second protrusion facing the fluid is subjected to the centripetal pressure from the fluid and more tightly wraps the needle when the needle extends through the septum, or more tightly closes the slit if a slit through the septum has been formed, thereby providing a better fluid seal.

[0102] Fig. 10C and 10D The barrier member 90 is shown assembled in the catheter sleeve 24. In one embodiment, as Fig. 10CAs shown, the barrier 90 is disposed at the distal end of the lumen 101 of the catheter sleeve 24, which receives the safety cap 26. The lumen 101 has a step 101A, at which the inner radial direction of the lumen 101 drops distally. Proximal to the step 101A, the outer diameter of the body 92 of the barrier 90 is large enough to provide a fluid-tight contact with the inner surface of the lumen 101 of the catheter sleeve 24. Distal to the step 101A, the first protrusion 94 of the barrier 90 extends into the lumen 101 distal to the step 101A. It is to be understood that the barrier may also be disposed at other locations within the lumen 101 of the catheter sleeve 24. In the example shown in FIG. Fig. 10D In another embodiment shown, the barrier 90 is sandwiched between two steps 101A and 101B formed in the inner surface of the lumen 101 of the catheter hub 24 .

[0103] In one embodiment, barrier 90 is made of polyisoprene, silicone rubber, polyurethane, butyl rubber, or latex.

[0104] Fig.11A and 11B FIG. 1 shows a barrier member 100 according to an embodiment of the present invention. Fig.11A In one embodiment, the barrier 100 includes a circular end 102 and a tubular portion 104 extending from the periphery of the end 102. In one embodiment, the barrier 100 is tubular in shape, having a closed end (circular end 102) at the distal end of the barrier 100 and an open end at the proximal end of the barrier 100. Specifically, in one embodiment, the end 102 is a circular thin film, and the tubular portion 104 extends from the periphery of the film in a direction perpendicular to the plane of the end 102.

[0105] In one embodiment, the barrier 100 further includes a protrusion 106 extending from a central portion of the surface of the circular end 102 opposite the tubular portion 104. In one embodiment, the protrusion 106 is in the form of a cylinder. In another embodiment, the protrusion 106 is in the form of a circular truncated cone that tapers from the bottom surface. The protrusion 106 is coaxial with the circular end 102. In one embodiment, the protrusion 106, the circular end 102 and the tubular portion 104 form a single piece.

[0106] Similar to barrier 90 , end 102 of barrier 100 may be formed with or without slits.

[0107] Fig. 11BThe barrier 100 assembled on the distal portion of the safety cap 26 is shown. In one embodiment, the barrier 100 is disposed on the fingers of the safety cap 26, wherein the sidewall of the tubular portion 104 includes at least one recess 108 that allows a protrusion disposed on the finger to extend through the recess 108. In one embodiment, the number and position of the recesses 108 disposed on the tubular portion 104 corresponds to the number and position of the protrusions disposed on the fingers of the safety cap 26. As described above, the fingers of the safety cap are separated from each other at the distal portion of the fingers and are configured to be radially offset when the needle is wrapped and to converge toward the center when the needle is pulled out therefrom. The barrier 100 is configured to cover / cover the fingers so as to provide a seal to prevent blood from leaking from the fingers of the safety cap.

[0108] Furthermore, when the finger 62 of the safety cap 26 is completely or partially located within the lumen 101 of the catheter sheath 24, for example Figure 7B , Fig. 9 or Fig. 10D As shown, the barrier 100 disposed on the finger 62 enhances the seal between the safety cap 26 and the catheter hub 24. The barrier 100 provides appropriate friction between the safety cap 26 and the catheter hub 24, and the friction requires the user / clinician to apply force to separate the catheter hub 24 and the safety cap 26 when the safety cap 26 is slid to the locked position in which the tip of the needle is isolated in the safety cap.

[0109] In addition, as another embodiment, when the safety cap 26 and the catheter hub 24 are connected, the barrier 100 provided on the finger-shaped piece of the safety cap 26 and the barrier 90 provided in the lumen 101 of the catheter hub 24 contact each other. Specifically, in one embodiment, when the finger-shaped piece portion of the safety cap 26 is fully inserted into the lumen of the catheter hub 24, the body 92 or protrusion 94 / 98 of the barrier 90 is in close contact with the protrusion 106 or end 102 of the barrier 100. Such a configuration can prevent blood leakage when the tip of the needle passes through the barrier 90 and 100, and thus prevent blood exposure when the safety cap 26 and the catheter hub 24 are separated from each other.

[0110] In one embodiment, barrier 100 is made of polyisoprene, silicone rubber, polyurethane, butyl rubber, or latex.

[0111] In one embodiment, Fig. 11B As shown, the catheter insertion tool 10 also includes a barrier 110 disposed in the lumen of the first portion 26A. Specifically, as an embodiment, the barrier 110 is cylindrical. In one embodiment, the thickness of the barrier 110 is configured to be less than the distance between the tip of the needle 18 and the notch so as to reduce the friction between the barrier 110 and the needle 18.

[0112] Similar to barrier 90 , barrier 110 may be formed with or without slits.

[0113] In one embodiment, the outer diameter of the barrier 110 is greater than the inner diameter of the lumen of the first portion 26A of the safety cap 26 before the barrier 110 is installed in the lumen.

[0114] In one embodiment, septum 110 is disposed in the proximal end of the lumen of first portion 26A to form a closed cavity with septum 100 and lumen 101. Thus, the closed cavity prevents blood from leaking when the tip of the needle is isolated within the closed cavity of safety cap 26.

[0115] In one embodiment, barrier 110 is made of polyisoprene, silicone rubber, polyurethane, butyl rubber, or latex.

[0116] Guidewire Advancement Assembly

[0117] Return to reference Figure 2 or Figure 3A In one embodiment, the insertion tool 10 includes a guidewire advancement assembly 30 for advancing a guidewire 32 distally into the patient's vascular system or withdrawing the guidewire proximally from the patient's vascular system. In one embodiment, the guidewire advancement assembly 30 also includes a pusher 34 for operating the movement of the guidewire 32 to prepare for advancement of the catheter 22.

[0118] Fig. 12A and 12B A cross-sectional view of the guidewire advancement assembly 30 is shown before and after advancement of the guidewire 32. In one embodiment, at least a portion of the guidewire 32 is disposed within the lumen of the needle 18. One end of the guidewire 32 is fixed to an anchor point 120 on the housing 12, and the guidewire 32 extends proximally from the anchor point 120, enters the hole 36 of the pusher 34 via a first portion of a guide track 122A, extends away from the hole 36, extends distally into a second portion of the guide track 122B, and ultimately extends through the needle hub into the lumen of the needle 18.

[0119] In one embodiment, guide rail 122A-B includes a groove aligned with hole 36 in the longitudinal direction of the catheter insertion tool. The groove is used to limit the guide wire 32 and prevent the guide wire 32 from shaking or bending undesirably during operation. Specifically, as an embodiment, the first part of the anchor point 120 and the guide rail 122A is arranged on the inner surface of the first part 12A of the housing 12. The upper opening of the anchor point 120, the first part of the guide rail 122A and the hole 36 of the pusher 34 are arranged in a straight line, which allows the guide wire 32 to extend straightly from the anchor point 120 to the hole 36. The second part of the guide rail 122B is arranged on the inner surface of the second part 12B of the housing 12. The bottom opening of the hole 36, the second part of the guide rail 122B and the proximal end of the needle 18 are arranged in a straight line, which enables the guide wire 32 to extend straightly from the hole 36 to the lumen of the needle 18. In another embodiment, at least a portion of the guide rail 122A-B is a pipeline.

[0120] Fig. 12A FIG. 2 shows the construction of the guidewire advancement assembly 30 before operation, wherein the pusher 34 is positioned near the proximal end of the housing. When the pusher 34 moves distally to a position close to the needle seat, as shown in FIG. Fig. 12B As shown, guidewire 32 is advanced distally a distance twice the distance that pusher 34 is moved.

[0121] Figures 13A-13C The structure of the pusher 34 is shown. Fig.13A 1 is a perspective view of an embodiment of the pusher 34, wherein the pusher 34 includes a push block 130 and a slider 132. In one embodiment, the push block 130 includes a hole 36 extending through the push block 130 from the top surface to the bottom surface of the push block 130.

[0122] Fig. 13B is a cross-sectional view of the push block 130, and Fig. 13C 1 is a perspective view of the push block 130. Fig. 13B and 13C As shown, the push block 130 includes four side walls defining the hole 36. In one embodiment, the four side walls of the hole 36 include a first side wall 134A in the form of a flat curve and a straight second side wall 134B opposite to the first side wall. The minimum distance between the first side wall 134A and the second side wall 134B is wide enough to allow free longitudinal movement of the guide wire 32 and narrow enough to limit the swing of the guide wire 32. In another embodiment, the second side wall 134B is also in the form of a flat curve, wherein the flat surface of the second side wall 134B is parallel to the flat surface of the first side wall 134A. In one embodiment, the other two side walls are straight.

[0123] Return to reference Figure 2 and Fig.13AIn one embodiment, the slider 132 is connected to the push block 130, the push block 130 is disposed inside the housing 12, and the slider 132 is partially disposed outside the housing 12. In one embodiment, a slit is formed between the second portion 12B of the housing and the proximal portion of the first portion 12A of the housing, the slit clamps the connection portion between the push block 130 and the slider 132, and allows the pusher 34 to slide relative to the housing 12.

[0124] Fig.14A and 14B Another embodiment of a guidewire advancement assembly 140 of the present invention is shown. In one embodiment, the guidewire advancement assembly 140 includes a wheel 142 and a gear 144, wherein the gear 144 is coaxially fixed to the wheel 142. The rotation of the gear 144 synchronously drives the rotation of the wheel 142. In one embodiment, the guidewire 32 is partially rolled around the outer diameter of the wheel 142.

[0125] In one embodiment, the guide wire advancement assembly 140 further includes a rack 146 that engages with the gear 144 through engagement between the teeth of the rack 146 and the teeth of the gear 144. In one embodiment, the distal end of the rack 146 is slidably attached to a guide rail disposed on the housing. The sliding movement of the rack 146 along the guide rail drives the rotation of the gear 144 and the rotation of the wheel 142, and the guide wire 32 is driven around the wheel 142 accordingly.

[0126] In one embodiment, the guidewire advancement assembly 140 further includes at least one idler wheel 148 for restraining the guidewire 32 on the peripheral surface of the wheel 142. In one embodiment, at least the peripheral surface of the wheel 142 is configured to provide sufficient friction to prevent slipping between the wheel 142 and the guidewire 32. This can be achieved by special treatment of the peripheral surface or by selecting a suitable material to form the surface.

[0127] In one embodiment, the guidewire advancement assembly 140 further includes a tubing guide for guiding the movement of the guidewire 32 .

[0128] The advancement efficiency of the guidewire advancement assembly 140 depends on the ratio between the diameters of the gear 144 and the wheel 142. For example, if the ratio between the diameters of the gear 144 and the wheel 142 is 1:3, then the ratio between the sliding distance of the rack 146 and the moving distance of the guidewire is also 1:3.

[0129] Procedure

[0130] Figures 4A-5C Various stages of operating the insertion tool 10 to place the catheter 22 in the vasculature of the patient are depicted. For clarity, the various stages are depicted without actual insertion into the patient shown. Figure 2With the insertion tool 10 of the structure shown, a user grasping the insertion tool 10 first guides the distal portion of the needle 18 through the patient's skin and into a subcutaneous blood vessel at the appropriate insertion site. Confirmation that proper vascular access has been achieved is evident by "blood flash," i.e., the presence of blood between the outer diameter of the needle 18 and the inner diameter of the catheter 22 due to blood flowing out of the hollow interior of the needle 18 through the notch. Note that in one embodiment, the presence of blood in the safety cap 26 due to blood entering the housing from the needle 18 as the blood vessel is entered serves as an auxiliary blood flash indicator.

[0131] After confirming that the needle has entered the blood vessel, the user operates the guidewire advancement assembly 30 or 140. In one embodiment, for Figures 12A-13C In the guidewire advancing assembly 30 shown, the pusher 34 is slid distally by the user's finger to distally advance the guidewire 32 initially disposed in the hollow needle 18. Figures 14A-14B In the guidewire advancement assembly 140 shown, the rack 146 is slid distally by the user's finger to distally advance the guidewire 32. The distal advancement of the guidewire continues until the pusher 34 has slid its entire stroke length distally, resulting in a predetermined length of the guidewire 32 extending beyond the distal end of the needle 18. In one embodiment, when the push block 130 contacts the needle hub, further distal advancement of the pusher 34 is prevented.

[0132] Once guidewire 32 has been extended to the patient's blood vessel fully, the user operates the catheter advancement assembly 20, wherein the catheter cover 24 is advanced distally by the user, so that catheter 22 slides distally on pin 18 and guidewire 32 and enters the patient's vascular system via the insertion site. At this stage, the further distal movement of catheter cover and catheter is prevented by the distal portion of housing. The user can then slide the first distal portion of the housing relative to the second portion of housing, to release the engagement between two housing portions. After the release, allow catheter cover and catheter to move further distally. It should be noted that in the process that catheter cover 24 slides distally, because safety cap 26 initially engages with catheter cover 24, safety cap 26 also slides with catheter cover 24.

[0133] After the catheter 22, catheter sleeve 24 and safety cap 26 are released from the housing, the user can further advance the catheter sleeve 24 distally and remove the needle 18 from the patient. These two movements can be performed simultaneously or sequentially. When the safety cap is locked to the locking point and the tip of the needle is isolated in the safety cap, the movement of the catheter sleeve and safety cap relative to the needle or housing distally is stopped.

[0134] When the tip of the needle is extracted from the finger-shaped member of the safety cap and stays in the lumen of the first part of the safety cap, the catheter cover 24 can be freely separated from the safety cap by the user. As mentioned above, the barrier in the catheter cap and the safety cap prevents the patient's blood from being exposed. Then the catheter 22 is retained in the patient's body, and the catheter cover 24 keeps close to the insertion site, and the housing 12, the needle 18, the safety cap 26 and the guide wire propulsion assembly can be removed.

[0135] In one embodiment, the insertion tool 10 of the present invention may include a cap or other protective device that is removably attached to the insertion tool prior to use to protect the needle and catheter.

[0136] Without departing from the spirit of the present disclosure, the embodiments of the present invention may be implemented in other specific forms. The described embodiments should be considered to be merely illustrative and not restrictive in all aspects. Therefore, the scope of the embodiments is indicated by the appended claims rather than the preceding description. All changes within the meaning and scope of the equivalents of the claims will be included within their scope.

Claims

1. A barrier member for a catheter insertion tool, comprising: Cylindrical body; and A first protrusion extends from a central portion of the top surface of the body.

2. The barrier of claim 1, further comprising a slit formed in the barrier along a longitudinal axis of the barrier.

3. The barrier member according to claim 2, wherein: The slit is formed in the first protrusion. The barrier of claim 2 , wherein the slit extends through the barrier.

5. The barrier member according to claim 2, wherein: When the needle extends through the slit, the slit is enlarged; and when the needle is withdrawn from the barrier, the slit is closed.

6. The barrier member according to claim 1, wherein: Before the barrier is installed in the lumen of the catheter insertion tool, the outer diameter of the body of the barrier is greater than the inner diameter of the lumen.

7. The barrier member according to claim 1, wherein: The first protrusion is in the form of a circular frustum tapering from the top surface.

8. The barrier member according to claim 7, wherein: The top surface of the circular frustum is rounded at the periphery.

9. The barrier member according to claim 1, wherein: The top surface of the barrier is rounded at the periphery.

10. The barrier member according to claim 1, wherein: The first protrusion is in the form of a cylinder.

11. The barrier member according to claim 1, further comprising: A second protrusion extends from a central portion of a bottom surface of the body opposite to the top surface.

12. The barrier member according to claim 11, wherein: The second protrusion is in the form of a circular frustum tapering from the bottom surface.

13. A tool for inserting a catheter into a patient's body, comprising: a housing in which at least a portion of the conduit is initially disposed; a needle extending distally from the housing, at least a portion of the catheter being disposed on the needle; a guide wire initially partially disposed within the needle; an advancement assembly for distally advancing the catheter; and The barrier member according to claim 1, which is disposed in the propulsion assembly.

14. A barrier member for a catheter insertion tool, comprising: Rounded ends; and A tubular portion extends from the periphery of the end portion.

15. The barrier member according to claim 14, further comprising: A protrusion extends from a central portion of a surface of the circular end portion opposite the tubular portion.

16. The barrier member according to claim 14, wherein: A slit is formed in the end portion.

17. The barrier member according to claim 16, wherein: The slit is formed in the protrusion.

18. The barrier member according to claim 16, wherein: The slit extends through the end portion.

19. The barrier member according to claim 16, wherein: When the needle is extended through the slit, the slit is enlarged; and when the needle is withdrawn the slit is closed.

20. The barrier member according to claim 14, wherein: The tubular portion includes at least one aperture.

21. A tool for inserting a catheter into a patient's body, comprising: a housing in which at least a portion of the conduit is initially disposed; a needle extending distally from the housing, at least a portion of the catheter being disposed on the needle; a guide wire initially partially disposed within the needle; an advancement assembly for distally advancing the catheter; and The barrier member according to claim 14, which is disposed in the propulsion assembly.

22. A guidewire advancement device for a catheter insertion tool, comprising: a push block including a hole extending through the push block from a top surface to a bottom surface of the push block, wherein a first side wall of the side walls of the hole is in the form of a flat curve; as well as A guide rail includes a groove aligned with the hole in the longitudinal direction of the catheter insertion tool.

23. The guidewire advancement device according to claim 22, wherein: The aperture has a second sidewall opposite the first sidewall, the second sidewall being straight, a minimum distance between the first sidewall and the second sidewall being wide enough to allow free longitudinal movement of the guidewire and narrow enough to limit swinging of the guidewire.

24. The guidewire advancement device according to claim 22, further comprising: An anchor point is secured to one end of the guide wire, the guide wire extends proximally from the anchor point, enters the hole via the first portion of the guide rail, extends out of the hole and extends distally into the second portion of the guide rail.

25. The guidewire advancement device according to claim 24, further comprising: A housing wherein the anchor point and the first and second portions of the guide rail are disposed on an inner surface of the housing.

26. The guidewire advancement device according to claim 25, further comprising: A slider is connected to the push block, wherein the push block is disposed inside the housing and the slider is partially disposed outside the housing.

27. The guidewire advancement device according to claim 26, wherein: The pushing block and the sliding block are slidable relative to the housing.

28. The guidewire advancement device according to claim 22, wherein: At least a portion of the rail is a tube.

29. A tool for inserting a catheter into a patient's body, comprising: a housing in which at least a portion of the conduit is initially disposed; a needle extending distally from the housing, at least a portion of the catheter being disposed on the needle; an advancement assembly for distally advancing the catheter; a guide wire initially partially disposed within the needle; and The guidewire advancement device according to claim 22, which is used to drive the guidewire.

30. A guidewire advancement device for a catheter insertion tool, comprising: wheel; and A rack is configured to rotate the wheel so that the guide wire is driven around the wheel.

31. The guidewire advancement device of claim 30, further comprising: A gear is coaxially fixed to the wheel, wherein the rack includes teeth that engage the gear.

32. The guidewire advancement device of claim 30, further comprising: At least one idler wheel for constraining the guidewire to a peripheral surface of the wheel.

33. The guidewire advancement device of claim 30, further comprising: A tubular guide rail is used to guide the movement of the guide wire.

34. A tool for inserting a catheter into a patient's body, comprising: a housing in which at least a portion of the conduit is initially disposed; a needle extending distally from the housing, at least a portion of the catheter being disposed on the needle; an advancement assembly for distally advancing the catheter; a guide wire initially partially disposed within the needle; as well as The guidewire advancement device of claim 30, which is used to drive the guidewire.

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