Catheter insertion device

Abstract

The present invention discloses a catheter insertion device that allows for single-handed insertion of a catheter into a patient's blood vessel. The catheter insertion device includes a handle, a needle cannula partially within the handle, a guide wire partially within the handle and the needle cannula, and a first actuator connected to the handle and the guide wire. The guide wire is movable relative to the handle in a distal direction away from the handle and in a proximal direction toward the handle. A catheter assembly is detachably coupled to the handle and is configured to slide over the needle cannula. A catheter base can be connected to the proximal end of the catheter, and a catheter pusher base can be releasably connected to the catheter base. The catheter insertion device can further include a needle support that is pivotally connected to the handle for supporting the needle cannula on its cantilever portion.

Description

[0001] This application is a divisional application of the patent application for "Catheter Insertion Device" with an international filing date of April 11, 2018, an international application number of PCT / US2018 / 027078, and a national application number of 201880033843.8.

[0002] Cross - reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 485,167, filed on April 13, 2017, the disclosure of which is incorporated herein by reference in its entirety. Technical field

[0004] The present disclosure generally relates to medical devices for inserting a catheter or other medical equipment into a patient's blood vessel. More particularly, the present disclosure relates to a catheter insertion device for at least partially inserting a catheter within a patient's blood vessel. Background art

[0005] Different types of medical devices (e.g., needles, introducers, cannulas, catheters, stents, angiography balloons, cutting tools, and imaging tools) can be introduced into the body for various medical procedures. For example, a catheter is used to introduce fluid into or drain fluid from a blood vessel in the body for various medical procedures. In a typical procedure, to insert a catheter into a blood vessel, first, a long hollow needle (e.g., a syringe needle) is used for aspiration to verify vascular access. Then a guide wire is passed through the needle into the blood vessel. The guide wire serves as a track for the catheter to travel to reach a target position within the blood vessel. The catheter ultimately passes over the guide wire to reach the target position in the patient's blood vessel. When the catheter is in place, the needle and the guide wire are removed, leaving only the catheter in the blood vessel. Then, a fluid source or a suction device is connected to the catheter hub to introduce or drain fluid through the catheter into the blood vessel.

[0006] There are various known devices for placing a catheter in a patient's blood vessel. Maintaining the sterility of the various components of the device is important for the use of these devices, for example, by preventing the operator's fingers from contacting the various parts of the guide wire, the catheter itself, and the needle during the operation. However, conventional catheter placement devices typically require the use of both hands for inserting the guide wire and advancing the catheter into the blood vessel, which increases the risk of contamination and also increases the risk of inadvertently damaging the blood vessel due to accidental needle movement. In addition, conventional catheter placement devices also impede the continuous use of ultrasound from the point of skin penetration, vascular access, and wire introducer insertion, such that the first distal portion of the catheter and the needle in the blood vessel are shielded. This results in such conventional catheter placement devices being less convenient to use. Additionally, the above - mentioned drawbacks of conventional catheter placement devices affect the success rate of insertion into the blood vessel.

[0007] Accordingly, there is a need for a new catheter insertion device that allows for single-handed insertion of a catheter into a patient's blood vessel. Additionally, there is a need for a catheter insertion device that allows for easy, safe, and rapid placement of a catheter into a patient's blood vessel. Summary of the Invention

[0008] Embodiments of the catheter insertion device according to the present disclosure largely meet the above needs. According to one embodiment, the catheter insertion device may include: a handle having a proximal body portion and two suspension arms, each suspension arm extending distally from the body portion; a needle cannula having a proximal end disposed within the proximal body portion of the handle, the needle cannula extending distally from the proximal body portion of the handle and defining a distal cantilever portion partially disposed between the two suspension arms of the handle; a catheter assembly removably coupled to the handle and configured to slide over the needle cannula, the catheter assembly including an elongate catheter, a catheter base connected to the proximal end of the elongate catheter, and a catheter pusher base connected to the catheter base; and a needle support having two parallel walls pivotally connected to the handle, the needle support pivoting between a first position and a second position, and when the needle support is in the first position and the needle cannula is disposed between the two parallel walls of the needle support, the needle support is configured to support the needle cannula on the cantilever portion of the needle cannula, and when the needle support is in the first position, the needle support blocks the catheter assembly from advancing distally.

[0009] In some embodiments, the catheter insertion device may include a guide wire and a guide wire actuator for extending or retracting the guide wire, wherein the needle support cannot pivot away from the first position until the guide wire actuator is moved to extend the guide wire distally past the tip of the needle cannula.

[0010] In some embodiments, the two arms of the handle include a top arm and a bottom arm, and the catheter pusher base is slidably engaged with the bottom arm of the handle.

[0011] In some embodiments, the catheter pusher base may include a guide track configured to receive the bottom arm of the handle for moving the catheter assembly in a distal direction and a proximal direction relative to the handle, wherein the guide track prevents the catheter assembly from twisting during movement of the catheter assembly in both the distal and proximal directions.

[0012] In some embodiments, the catheter pusher base may include a pair of holding arms for supporting the position of the user's blocking hand.

[0013] In some embodiments, the needle support is pivotally connected to the distal portion of the top arm of the handle and is configured to be movable relative to the handle when the catheter pusher base abuts against the needle support.

[0014] In some embodiments, the needle support is configured to pivot relative to the handle about a pivot axis perpendicular to the axis of the needle cannula.

[0015] In some embodiments, the needle support may further include a hook portion configured to releasably mate with the bottom arm of the handle when the needle portion is in a first position.

[0016] In some embodiments, moving the guidewire actuator proximally relative to the handle causes the distal end of the guidewire to move distally away from the handle, and moving the guidewire actuator distally relative to the handle causes the distal end of the guidewire to move proximally toward the handle.

[0017] In some embodiments, the catheter insertion device may include a catheter assembly actuator coupled to the handle, the catheter assembly actuator being movable relative to the handle to push the catheter assembly distally relative to the handle.

[0018] In some embodiments, the catheter pusher base may further include a seat portion configured to stably secure the catheter and the catheter base.

[0019] In some embodiments, the catheter pusher base may further include a retaining member configured to secure the catheter base.

[0020] In some embodiments, the needle support may further include a textured surface to assist in gripping.

[0021] In some embodiments, the needle cannula may further include a sharp distal tip extending distally from the handle, the distal tip having a back bevel portion defining a taper.

[0022] In some embodiments, the guidewire further has a variable stiffness.

[0023] In some embodiments, the needle cannula further includes a swaged portion having an oval cross-sectional bulge near the distal tip of the needle cannula.

[0024] In some embodiments, a catheter insertion device includes: a handle having a body portion and an arm extending distally from the body portion; a needle cannula partially located within the handle, the needle cannula including a sharp distal tip extending distally from the handle; a catheter assembly removably coupled to the handle, the catheter assembly including an elongate catheter, a catheter pusher base having a seat portion, and a catheter hub connected to the elongate catheter and matingly received within the seat portion of the catheter pusher base; and a needle support connected to the handle and movable between a first position and a second position, the needle support configured to stabilize lateral movement of the needle cannula when in the first position and further configured to block distal advancement of the catheter assembly when in the first position.

[0025] In some embodiments, the needle support is configured to allow distal advancement of the catheter assembly when in the second position.

[0026] In some embodiments, the catheter insertion device further includes a guidewire partially disposed within the handle and a first actuator connected to the handle and the guidewire, the first actuator movable between an extended position where the needle support is in the first position and the first actuator abuts the needle support and a retracted position where the needle support is in the first position and the first actuator does not abut the needle support, and wherein moving the first actuator between the extended position and the retracted position causes the guidewire to move relative to the handle.

[0027] In some embodiments, the catheter insertion device further includes a second actuator connected to the handle, the second actuator configured to move the catheter assembly distally relative to the handle and move the needle support from the first position to the second position when the first actuator does not abut the needle support.

[0028] Certain embodiments of the catheter insertion device have been outlined above so that the detailed description below can be better understood. Of course, there are additional embodiments that will be described below, which will form the subject matter of the claims. In this regard, it should be understood that the catheter insertion device is not limited in its application to the details of the construction and the arrangement of components set forth in the following disclosure or shown in the drawings. Further, it should be understood that the language and terminology used herein are for the purpose of description and should not be regarded as limiting. Accordingly, the concepts upon which this disclosure is based can readily be utilized as a basis for other structures, methods, and systems designed to achieve several purposes of the catheter insertion device. Therefore, it should be understood that the claims include such equivalent structures as long as they do not depart from the spirit and scope of this disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1A A top perspective view of an embodiment of a catheter insertion device including a catheter set and an insertion set is shown.

[0030] Figure 1B shows Figure 1A a side view of a catheter insertion device.

[0031] Figure 2A shows an exploded view of the individual components of the catheter set of the catheter insertion device.

[0032] Figure 2B shows a partially transparent perspective view of the assembled catheter set of the catheter insertion device.

[0033] Figure 3A shows a partially exploded view of the catheter insertion device.

[0034] Figure 3B shows a top perspective view of the catheter insertion device with a protective needle guard.

[0035] Figure 3C shows a side view of the catheter insertion device with a protective needle guard.

[0036] Figure 3D shows an enlarged bottom perspective view of a portion of the catheter insertion device.

[0037] Figure 3E shows an enlarged top perspective view of a portion of the catheter insertion device.

[0038] Figure 3F shows an enlarged side view of a portion of the catheter insertion device.

[0039] Figure 3G shows a catheter insertion device having a slider in a retracted position and a needle support in a vertical position.

[0040] Figure 3H shows an enlarged bottom perspective view of a portion of the catheter insertion device with a protective needle guard.

[0041] Figure 4A shows a top perspective view of the catheter pusher base and the needle support.

[0042] Figure 4B shows a top perspective view of the catheter pusher base, the needle support, and the assembled catheter set.

[0043] Figure 5A shows a cross-sectional side view of the right housing of the assembled catheter insertion device.

[0044] Figure 5B shows a cross-sectional view of the handle of the assembled catheter insertion device.

[0045] Figure 6A side view of a portion of a slider of an insertion set of a catheter insertion device is shown.

[0046] Figure 7A A partially cut-away view showing a catheter pusher base member and a release member of an insertion set of a catheter insertion device, and a portion of a handle of the catheter insertion device is shown.

[0047] Figure 7B An enlarged view of a release member of an insertion set of a catheter insertion device without the catheter pusher base member is shown.

[0048] Figure 7C A side view of the release member in an extended position is shown.

[0049] Figure 8A A perspective view of a region of an assembled catheter insertion device having a slider in a fully extended position and a release member in a fully retracted position is shown.

[0050] Figure 8B A cross-sectional side view of a region of a catheter insertion device taken along a central longitudinal plane of a handle in a pre-advancement position of a catheter set is shown.

[0051] Figure 8C A cross-sectional side view of the region of the catheter insertion device along the central longitudinal plane of the handle after a doctor actuates the slider is shown.

[0052] Figure 8D A cross-sectional side view of the region of the catheter insertion device along the central longitudinal plane of the handle after a doctor actuates the release member is shown.

[0053] Figure 8E A cross-sectional side view of the region of the catheter insertion device along the central longitudinal plane of the handle after a doctor further advances the catheter set along the handle is shown.

[0054] Figure 8F A side view of the region of the catheter insertion device after a doctor advances the catheter set from the handle is shown.

[0055] Figure 9A A perspective view of a needle safety clip at a catheter base of a catheter set mounted to a catheter insertion device is shown.

[0056] Figure 9B A rear view of the needle safety clip is shown.

[0057] Figure 9C A front view of the needle safety clip is shown.

[0058] Figure 9DShows an enlarged perspective view of a needle safety clip released from the catheter base of the catheter set of a catheter insertion device.

[0059] Figure 9E Shows a perspective view of an embodiment of a sharp needle tip of a needle according to the present disclosure.

[0060] Figure 9F Shows a sharp needle tip withdrawn from the needle safety clip.

[0061] Figure 10A Shows the insertion set being pulled proximally to a position where the sharp needle tip of the needle is located between the two distal sidewalls of the needle safety clip.

[0062] Figure 10B Shows the insertion set being pulled proximally to a position where the sharp needle tip of the needle is proximal to both of the two distal sidewalls of the needle safety clip and the sharp needle tip of the needle is inclined relative to the needle safety clip.

[0063] Figure 11A Shows a perspective view of an embodiment of a seal having two parts according to the present disclosure.

[0064] Figure 11B Shows Figure 11A the proximal part of the two - part seal.

[0065] Figure 11C Shows Figure 11A the distal part of the two - part seal.

[0066] Figure 11D Shows a partial cross - sectional view of the Figure 11A seal within the catheter base of the catheter set.

[0067] Figure 12 Shows a perspective view of the distal region of a needle showing multiple echo features.

[0068] Describes an embodiment of a catheter insertion device with reference to the accompanying drawings, where like reference numerals refer to like parts throughout the text. Detailed Description

[0069] With reference to Figure 1A and Figure 1B, an embodiment of a catheter insertion device 100 including a catheter set 102 and an insertion set 104 is shown. The insertion set 104 can be separated from the catheter set 102 after the catheter 106 is partially inserted into a patient's blood vessel. The catheter set 102 further includes an extension line assembly 108 that is in fluid communication with the catheter 106. The extension line assembly 108 can be connected to a fluid source or a suction device. The insertion set 104 includes a handle 110 that is initially connected to the catheter set 102 and that facilitates the insertion of the catheter 106 into a patient's blood vessel.

[0070] Figure 2A A exploded view of the individual components of the catheter set 102 of the catheter insertion device 100 is shown. Referring to Figure 2B , a partially transparent perspective view of the assembled catheter set 102 of the catheter insertion device 100 is shown. In its proximal region, the catheter set 102 includes an extension line assembly 108 that includes an elongate extension line 112, an extension line clip 114, and an extension line base 116. As Figure 1A shown, during the insertion of the needle, a vent plug can be further attached to the extension line base 116 and then removed before being used by a doctor (i.e., before the doctor connects a syringe to the extension line base 116). The elongate extension line 112 defines an elongate inner lumen that is in fluid communication with the inner lumen defined by the catheter 106 through the inner lumen defined by a rigid base 120. The extension line clip 114 is mounted around the elongate extension line 112 and can slide in a direction perpendicular to the longitudinal axis of the elongate extension line 112 to clamp the elongate extension line 112 closed. When the extension line clip 114 clamps the elongate extension line 112, fluid is prevented from flowing distally towards the catheter 106 or proximally towards the extension line base 116 past the extension line clip 114. The extension line base 116 defines an inner lumen that is in fluid communication with the inner lumen defined by the elongate extension line 112.

[0071] In some embodiments, the inner lumen defined by the extension line base 116 can taper from its proximal end towards its distal end, while in other embodiments, the inner lumen defined by the extension line base 116 has a uniform diameter. The proximal end of the extension line base 116 includes a connector, such as a threaded luer lock, for connection to a fluid source or a suction device. The fluid source can be a syringe or an intravenous bag, etc.

[0072] At the distal end of the catheter assembly 102, the catheter assembly includes an elongate catheter 106 connected to a catheter base 118. In particular, the proximal end of the elongate catheter 106 is connected to the distal end of the catheter base 118. A rigid base 120 is partially received within the proximal end of the catheter base 118. The rigid base 120 receives a seal 218 that acts as a valve within an internal cavity defined by the rigid base 120. The proximal end of the rigid base 120 is sealed by a rigid base cap 124. The proximal end of the rigid base cap 124 has an opening that allows a needle cannula 130 and a guide wire 132 to pass through the rigid base cap 124 to the seal 218. The elongate catheter 106 defines an elongate internal lumen that is at least partially received within a blood vessel of a patient. The catheter base 118 defines a tapered cavity that is in fluid communication with the internal lumen defined by the elongate catheter 106 and the internal lumen defined by the rigid base 120. The rigid base 120 also includes a side port portion 121 for receiving an elongate extension line 112 of an extension line assembly 108. The internal lumen defined by the side port portion 121 is in fluid communication with the internal lumen defined by the elongate extension line 112.

[0073] The seal 218 is a multi-piece seal as described in more detail below. In other embodiments, the seal may be a one-piece seal as described in U.S. Patent Application No. 14 / 306,698, filed June 17, 2014, the entire disclosure of which is incorporated herein by reference in its entirety. When the catheter assembly 102 is assembled, the seal 218 is encapsulated by the rigid base 120 and the rigid base cap 124. In some embodiments, the catheter assembly 102 may not include the extension line assembly 108, and a fluid source or a suction device may be connected to the proximal end of the rigid base 120.

[0074] Referring Figure 3A , an exploded view of the individual components of the insertion assembly 104 of the catheter insertion device 100 and a view of the assembled catheter assembly 102 are shown. Figure 3B and Figure 3C Perspective and side views, respectively, of the assembled catheter assembly 102 and insertion assembly 104 of the catheter insertion device 100 are shown. The insertion assembly 104 includes a handle 110 that is formed by a right housing 126 and a left housing 128 connected together. A top arm 127 and a bottom arm 129 are formed in the distal region of the handle 110. The needle cannula 130 is held within the handle 110, and the guide wire 132 is also held within the handle 110 and is slidable through the internal lumen defined by the needle cannula 130. The needle cannula 130 may be anchored within the handle 110 by an interference fit, an adhesive, a threaded connection, etc. within an internal channel defined by the handle 110. For example, in some embodiments, the needle cannula 130 may be a 24-gauge needle.

[0075] After the insertion set 104 is separated from the catheter set 102, the needle safety clip 134 is placed around the outer surface of the needle cannula 130 to cover the sharp needle tip 131. Prior to initial use of the catheter insertion device 100, the needle guard 137 covers the portion of the needle cannula 130 extending from the handle 110. The first actuator (e.g., slider 138) is connected to the top of the handle 110 and the guide wire 132 and enables the guide wire 132 to slide relative to the handle 110 in both the proximal and distal directions. In some embodiments, the guide wire 132 can be a spring wire guide, such as a coiled or uncoiled spring wire guide. The length of the guide wire 132 is selected such that the distal end of the guide wire does not extend beyond the sharp needle tip 131 of the needle cannula 130 before the slider 138 is actuated.

[0076] As discussed further below, the guide wire 132 can have a variable stiffness. In some embodiments, the guide wire 132 can have a substantially uniform outer diameter that is less than or equal to 0.010 inches (0.0254 cm). Preferably, when the needle cannula 130 is a 24GA needle and the elongate catheter 106 is a 22GA catheter, the guide wire 132 has an outer diameter that is less than or equal to 0.010 inches such that the guide wire 132 can fit within the lumen defined by the 22GA catheter. In other embodiments, the guide wire 132 can have a varying diameter that tapers distally such that the diameter of the guide wire 132 is smallest at the distal end of the guide wire 132. When the guide wire 132 is fully advanced, the larger diameter portion is distal of the needle 130, which helps to guide the elongate catheter 106 during advancement and to guide the movement of the catheter during the initial portion of the advancement. Additionally, the distal end of the guide wire 132 has a small outer diameter such that it is flexible enough to help the guide wire 132 pass through a tortuous path out of the needle cannula 130 and into the lumen of the blood vessel. The guide wire can also include a large diameter end, such as an end shaped like a ball, such that it is not sharp. Such a large spherical end helps the clinician to determine whether the entire guide wire has been removed after use because the clinician can see if the ball is there, indicating that no guide wire remains. Additionally, the spherical end of the distal end of the guide wire 132 is not sharp to avoid piercing the patient's blood vessel during the procedure.

[0077] In some embodiments, the guide wire 132 can be made of metal, such as a metal alloy. For example, the guide wire 132 can be made of nitinol. In some embodiments, the guide wire 132 can be coated with polysulfone, fluorocarbon, polyolefin, polyester, polyurethane, blends, and / or copolymers.

[0078] The second actuator (e.g., release member 140) is also connected to the handle 110 of the insertion set 104 and the catheter set 102. The release member is configured to slide the catheter set 102 relative to the handle 110 in the distal direction. The release member 140 includes a proximal arm 174 having an enlarged proximal end 141. The needle support 142 is attached at a proximal region of the handle 110 and is pivotable up and down relative to the handle 110. In particular, the needle support 142 is rotatably coupled to the top arm 127 by a pivot member 144.

[0079] The catheter pusher base 318 is detachably connected to the catheter base 118 and is configured to slidably engage the bottom arm 129 of the handle 110, as Figure 3D shown. The needle support 142 may include a rigid plastic material to support the needle cannula 130 against bending during insertion of the needle cannula into a patient's blood vessel. The needle support 142 includes two parallel walls 143 that are separated by a distance slightly greater than the outer diameter of the elongate catheter 106 through which the needle cannula 130 extends, for controlling the lateral movement of the needle cannula 130 during insertion of the needle into the patient's blood vessel. This control is particularly important for inserting the needle relatively deeply into the patient's tissue (e.g., within the patient's organ). Additionally, the needle support may further include a textured outer surface to assist the doctor in holding the catheter during insertion into the patient's blood vessel. Examples of such a textured outer surface include protrusions, depressions, grooves, channels, and ridges of various patterns, etc. In other embodiments, the textured surface may be formed of a different material (e.g., rubber), or may be formed directly on the needle support 142 as a rough surface. In some embodiments, such examples of the textured surface may also be added to regions of the catheter pusher base 318, such as regions of the holding arm 321 or the holding recess 322, etc., to assist in holding.

[0080] As Figure 3E and Figure 3F shown, the needle support 142 also includes a top portion 147 that abuts against the bottom surface of the slider 138 before the slider slides proximally, for preventing the needle support 142 from swinging during insertion of the catheter insertion device 100 into the patient's blood vessel. A lip 149 may be provided on the needle support 142 that defines a seat region configured to hook around the distal end of the bottom arm 129 of the housing to prevent the needle cannula 130 and / or the elongate catheter 106 from prematurely popping out of the needle support 142. Additionally, the needle support 142 may include a trapezoidal or other geometric shape and may have an extended longitudinal length, such as 2 cm, which is configured to provide additional support to the catheter.

[0081] As Figure 3GAs shown, when the slider 138 is retracted to the extent that it no longer abuts against the top portion 147 of the needle support, the needle support 142 can freely swing about the pivot member 144. The catheter pusher base 318 is configured to receive the catheter base 118 of the catheter set 102, as will be discussed in more detail below. A retaining member 323, such as a projection clip, is provided on the catheter pusher base 318, and the projection clip is configured to further fix the wings of the catheter base 118 to assist in holding the catheter base 118 at the catheter pusher base 318 during deployment.

[0082] Referring Figure 3H , the needle guard 137 includes an open channel 260 defined by two parallel side walls 262. The bottom longitudinal feature and the top longitudinal feature between the parallel side walls 262 are fixed around the needle cannula 130. Thus, the separated distance between the bottom longitudinal feature and the top longitudinal feature is slightly larger than the outer diameter of the catheter 106. A tab portion 268 may be provided at the proximal end of the needle guard 137 to allow the doctor to initially lift the needle guard 137 out of contact with the slider 138 and then push the needle guard 137 distally until the proximal ends of both the bottom longitudinal feature and the top longitudinal feature are located distal to the sharp needle tip 131. Here, the needle guard 137 is disengaged from the insertion set 104 and can be removed to expose the sharp needle tip 131.

[0083] Referring Figure 4A , the catheter pusher base 318 and the needle support 142 are shown independent of the rest of the catheter insertion device 100. Figure 4B The catheter set 102 engaged with the catheter pusher base 318 and the needle support is shown. The upper surface of the catheter pusher base 318 includes a catheter seat portion 319, and the catheter seat is configured to cooperatively receive the catheter base 118. In one embodiment, the retaining member 323 may be configured to allow the catheter base 118 to snap firmly into the catheter seat portion 319. A pair of spaced fasteners, such as pins 320, are provided within the catheter seat portion 319 for connection to respective connection holes on each wing segment extending outwardly on opposite sides of the catheter base 118. When the catheter pusher base is advanced distally during catheter insertion, the catheter base 118 remains connected to the catheter pusher base 318 and moves therewith, as will be discussed in detail below.

[0084] The catheter pusher base 318 can be disconnected from and removed from the catheter base 118 during the wrapping of the catheter 106 around the patient. The catheter pusher base 318 is also configured to stay with the catheter 106 during advancement and can be disconnected from it during wrapping. A longitudinal sliding groove 324 is provided on the bottom surface of the catheter pusher base 318, and the longitudinal sliding groove defines a guiding track configured to slidably engage the bottom arm 129 of the housing. The guiding track is configured to cause a sliding movement of the catheter pusher base 318 along the bottom arm 129 and also prevent the catheter pusher base 318 and the catheter base 118 from twisting about their longitudinal axes during the sliding movement when the catheter is being advanced forward during catheter insertion. Thus, when the catheter pusher base rides on the bottom arm 129 of the handle during catheter insertion, the guiding track is configured to prevent the twisting of the catheter pusher base 318, thereby also preventing the twisting of the catheter set 102 and its associated components.

[0085] Grip arms 321 are provided on each side of the catheter pusher base 318, and grip recesses 322 are also provided on each side of the catheter pusher base 318. The grip arms 321 and the grip recesses 322 allow the doctor to alternately hold the grip positions of the catheter pusher base 318, including the grip positions for the occluded hand. For example, in such an occluded hand position, the user can hold the catheter insertion device 100 with one hand by placing the thumb in the grip recess 322 located on the first side of the catheter pusher base 318 and placing the middle finger in the grip recess 322 located on the opposite second side of the catheter pusher base 318. Then, the user's index finger can be bent so that the index finger can manipulate the slider 138. In this occluded hand position, the user's hand position is closer to the distal end of the handle, which allows for improved control of the holding and advancing of the catheter pusher base 318 during operation. The catheter pusher base 318 can be symmetric about its longitudinal axis to allow both right-hand placement and left-hand placement by the user.

[0086] Referring Figure 5A , a cross-sectional side view of the right housing 126 including the slider 138 and the guide wire 132 is shown. The handle 110 includes an annular proximal end 151 through which the guide wire 132 passes. In particular, the guide wire 132 passes through a channel 153 defined by the handle 110. The diameter of the channel 153 is slightly larger than the diameter of the guide wire 132, such that the guide wire 132 passes through the channel 153 stably. The slider 138 can be slid proximally and distally by the doctor's finger (e.g., the index finger in an upper-handed operation or the thumb in a lower-handed operation) within a chamber 157 defined by the handle 110. The chamber 157 is sized slightly larger than the slider 138 to stabilize the movement of the slider 138 within the chamber 157.

[0087] Since the guide wire 132 forms a loop within the annular proximal end 151, the proximal movement of the slider 138 is translated into distal movement of the distal end of the guide wire 132, and vice versa. Compared with a linear geometry, the looped arrangement of the guide wire 132 also enables the catheter insertion device 100 to be operated with one hand while maintaining a continuous grip on the grip feature 148 of the handle 110. In addition, since the force applied by the doctor is indirectly applied to the guide wire 132, the looped arrangement of the guide wire 132 reduces the likelihood of the guide wire 132 piercing the patient's blood vessel during advancement.

[0088] Referring Figure 5B , a cross-sectional view of the assembled handle 110 with the guide wire 132 and the slider 138 is shown. The handle 110 includes a grip feature 148 that helps the doctor hold the handle 110 of the catheter insertion device 100. For example, a right-handed doctor can hold the grip feature 148 on the left housing 128 with his thumb and hold the grip feature 148 on the right housing with his middle finger. Alternatively, for example, a left-handed doctor can hold the grip feature 148 on the left housing 128 with his middle finger and hold the grip feature 148 on the right housing with his thumb. The handle 110 can be held by the doctor with the same fingers, either with the hand up or down. The grip feature 148 can include a plurality of recessed lines, grooves, corrugations, protrusions, or rough surfaces formed on the outer surface of the handle 110, etc. For example, protruding lines can be formed at the positions of the recessed lines, a textured surface can be formed, a plurality of protrusions can be formed, or different materials, such as rubber, can be provided in the area of the handle 110 corresponding to the grip feature 148.

[0089] Three openings are defined in the front face 150 of the handle 110. The bottom opening 152 is sized to receive the rigid base cover 124 of the catheter set 102. In particular, the diameter of the bottom opening 152 is slightly larger than the diameter of the rigid base cover 124. The middle opening 154 is sized to receive the guide wire 132 and the needle cannula 130, and the top opening 156 is sized to receive the slider 138 and the proximal arm 174 of the release member 140. The top opening 156 includes a wider bottom region that receives the slider 138 and a narrower top region that receives the proximal arm 174 of the release member 140. The bottom opening 152 and the middle opening 154 are separated by a portion of the handle 110, while the middle opening 154 and the top opening 156 are not independent to allow the bottom arm 158 of the slider 138 to slide within the middle opening 154, as explained in more detail below.

[0090] In particular, referring Figure 6, shows a transparent side view of a portion of the slider 138. The slider 138 includes a bottom arm 158 that extends from the bottom of the slider 138 in a direction perpendicular to the longitudinal axis of the slider 138. The bottom arm 158 includes a through hole 160 that receives the proximal end 133 of the guide wire 132. The proximal end 133 may include a ball 162 to anchor the tip of the proximal end of the guide wire 132 in place. The inner diameter of the through hole 160 is slightly larger than the outer diameter of the guide wire 132, but slightly smaller than the diameter of the ball 162 formed at the tip of the guide wire 132. Thus, the guide wire 132 is fixed within the through hole 160 by an interference fit. The through hole 160 does not extend along the entire length of the bottom arm 158, so the distal end of the through hole 160 is closed. Although the ball 162 is fixed within the through hole 160 by an interference fit, in some embodiments, the ball 162 may be fixed by an adhesive, by a threaded connection, etc.

[0091] Due to the interference fit between the through hole 160 and the guide wire 132, when the slider 138 moves a certain distance in the longitudinal direction, the guide wire will also move the same distance in the opposite direction, and vice versa. In other words, the portion of the guide wire 132 located between the slider 138 and the loop portion in the handle will move in the same direction as the slider itself. Conversely, the portion of the guide wire 132 located between the loop portion of the handle and the distal end will move in the opposite direction to the slider 138. The slider 138 includes one or more gripping portions 164 that allow a doctor's finger (e.g., the index finger in an upper hand operation or the thumb in a lower hand operation) to predictably actuate the slider 138 in the distal or proximal direction. In some embodiments, the gripping portion 164 may be shaped like an arrow pointing in the proximal direction. Adjacent to each gripping portion 164 may be an indicating portion 166 (e.g., a number) that indicates the relative extension amount of the guide wire 132 extending distally relative to the sharp needle tip 131.

[0092] The guidewire 132 may also include a variable stiffness that aids in the insertion of the catheter 106 into a patient's blood vessel. In one embodiment, the guidewire 132 may include a plurality of different segments, such as: a first segment defined as a thin segment having an increased flexibility; a second segment defined as a tapered transition segment; and a third segment defined as a thick and rigid segment that assists the catheter 106 in subsequent bends of the guidewire. When the variable stiffness guidewire is fully extended, the third segment closest to the catheter 106 has the greatest stiffness, which helps the catheter to more easily follow any bends of the guidewire during insertion into the patient's blood vessel. The stiffness gradually decreases towards the distal end of the guidewire such that the first segment is the most flexible region since it has the smallest diameter, which may be, for example, between 0.005 inches and 0.006 inches. The increased flexibility of the first segment allows it to easily bend when entering the blood vessel to minimize perforation through the vessel wall. As described above, the spherical distal end of the guidewire 132 also helps to minimize such perforation through the vessel wall. The lengths of the segments of the guidewire may vary. In one embodiment, for example, the lengths of the first and third segments may be approximately 1.5 centimeters and the length of the second segment may be approximately 1.0 centimeter.

[0093] Figure 7A Shows a portion of the catheter insertion device, depicting the release member 140 and the catheter pusher base 318, Figure 7B Shows a portion of the catheter insertion device, depicting the release member 140 without the catheter pusher base 318. The distal side of the release member 140 includes a recess 168 that is configured to receive the side port portion 121 of the rigid base 120. The release member 140 is sized to be received around the bottom arm 129 into the slider 138. The recess 168 is sized slightly larger than the diameter of the side port portion 121 to stably secure the side port portion 121. When the doctor actuates the release member 140 in the distal direction, for example, using his index finger, the catheter set 102 is also actuated in the distal direction by the same distance through the engagement between the recess 168 and the side port portion 121.

[0094] As Figure 7C shown, the release member 140 includes a continuous sidewall 170. When the needle cannula 130 is still in the patient's blood vessel, if the doctor's finger were to push down onto the slider 138 or the top arm 127 of the handle 110, the resulting downward movement of the needle cannula 130 could damage the patient's blood vessel. Thus, the release member 140 includes a distal lip 172 that extends radially outward from the release member to help prevent the doctor's finger from slipping past the distal end of the release member 140.

[0095] The release 140 also includes a proximal arm 174 having an enlarged proximal end 141. The proximal arm 174 slides within the top opening 156 of the handle 110. The enlarged proximal end of the release 140 is sized to be larger than the top opening 156 so that distal movement of the release 140 is limited by the length of the proximal arm 174 and so that the release 140 does not separate from the handle 110. The release 140 may also include a grip 176 that allows a physician's finger (e.g., an index finger in an overhand operation or a thumb in an underhand operation) to predictably actuate the release 140 in either a distal or proximal direction.

[0096] Reference Figure 8A , a partially transparent perspective view of an area of ​​the assembled catheter insertion device 100 is shown. The bottom arm 129 of the right housing 126 and the bottom arm 129 of the left housing 128 abut against each other to support the weight of the catheter base 118. The distance between the top arm 127 of the right housing 126 and the top arm 127 of the left housing 128 is slightly greater than the width of the needle support 142 to allow the needle support 142 to swing upward during the removal of the catheter assembly 102. The outer surface of each opposing spaced-apart parallel wall 143 of the needle support 142 includes a pivot member 144 (e.g., a hinge) that is pivotally connected to the corresponding inner surface of each spaced-apart top arm 127 of the handle.

[0097] The needle support 142 includes two parallel walls 143 that are perpendicular to the plane of the top surface of the bottom arm 129. As described above, the distance between the parallel walls 143 is slightly larger than the outer diameter of the elongated catheter 106 to stabilize the needle cannula 130 during insertion into the patient's blood vessel. In various embodiments, the size of the parallel walls 143 of the needle support 142 matches the gauge size of the catheter or needle, such as 18ga, 20ga, or 22ga, etc. The two top arms 127 also include grooves 178 that are configured to receive corresponding tongues of the needle guard 137. Before the catheter insertion device 100 is used, such tongues and grooves are stably connected to fix the needle guard 137 to the handle 110 to protect the catheter.

[0098] Figures 8A to 8F 1 and 2 show various operational positions of the catheter insertion device 100 during advancement of the catheter assembly 102 from the insertion assembly 104. When the slider 138 is in the fully extended position, as shown in FIG. Figure 8BAs shown, the top portion 147 of the needle support 142 abuts against the bottom surface of the slider 138 to block the upward swing of the needle support 142, which in turn blocks the movement of the catheter pusher base 318, thereby locking the release member 140 from actuation to hold the catheter assembly 102 in place between the needle support 142 and the release member 140. When the slider 138 slides proximally toward the handle 110, as will be discussed below, the top surface 147 of the needle support 142 becomes free because this top surface no longer abuts against the bottom surface of the slider. In addition, the release member 140 becomes unlocked such that pushing the release member distally toward the needle support 142 causes the catheter pusher base 318 to contact the needle support 142 distally. Thus, the catheter pusher base 318 causes the needle support 142 to swing upwardly about the pivot member 144, creating a gap for the entire catheter assembly 102 to disconnect from the insertion assembly 104, as Figure 8F shown such that the catheter 106 can be advanced forward into the patient's blood vessel.

[0099] Before the doctor slides the slider 138 proximally, the distal end 139 of the slider 138 extends beyond the distal end of the top arm 127. Thus, this distal end of the slider extends distally along a portion of the needle support 142 but does not extend beyond the needle support. As Figure 8B shown in the cross-sectional view along the central longitudinal plane of the handle 110 of the area of the assembled catheter insertion device 100, the needle support is positioned in the support position such that before the slider 138 slides proximally, the bottom surface of the slider 138 abuts against the top portion 147 of the needle support 142 to prevent the needle support 142 from swinging out of engagement with the catheter before inserting the catheter into the patient's blood vessel.

[0100] At this support position or pre-advancement position, the needle support 142 blocks the forward movement of the catheter pusher base 318 and the catheter set 102. The portion of the catheter 106 near the distal end of the needle support 142 is supported to resist forces from three directions, such as forces from the bottom, left, and right. The portion of the catheter 106 near the proximal end of the needle support 142 is supported by the rigid catheter pusher base 318 to resist forces from a fourth direction, such as a force from the top. Thus, the needle support 142 provides sufficient support to the catheter 106 to increase its stiffness and avoid excessive bending during insertion of the catheter into the patient's blood vessel. A lip 149 is provided on the bottom of the needle support 142, which is configured to hook around the distal end of the bottom arm 129 of the handle to prevent the catheter set 102 from accidentally popping out during use. In addition, when the needle support 142 is positioned at the support position, the catheter pusher base 318 and the catheter base 118 remain nested between the top arm 127 and the bottom arm 129 of the housing 110 and are located between the release member 140 and the needle support 142 to hold the catheter set 102 during use.

[0101] Figure 8C A cross-sectional view of a region along the central longitudinal plane of the handle 110 of the assembled catheter insertion device 100 is shown after actuation of the slider 138 by a doctor. The distal end 139 of the slider 138 slides proximally towards the needle support 142 such that the top portion 147 no longer abuts against the bottom surface of the slider 138 and can swing freely upward when the catheter set 102 is separated from the insertion set 104.

[0102] Figure 8D A cross-sectional view of a region of the assembled catheter insertion device 100 along the central longitudinal plane of the handle 110 is shown after actuation of the release member 140 by a doctor. According to another aspect, the doctor can advance the catheter without using the release member 140. As Figure 8D shown, the release member 140 is pushed forward towards the distal end of the handle, causing it to correspondingly push the rigid base 120 distally such that the catheter pusher base 318 contacts the needle support 142 and causes the needle support 142 to swing upward about the pivot member 144.

[0103] The release member 140 can be pushed forward until it reaches a stop position, after which the doctor can continue to advance the catheter set 102 by holding the catheter pusher base 318 and moving it forward. According to another aspect, the doctor can hold the extension line assembly 108, or more specifically, hold the arm of the rigid base including the extension line, to advance the catheter set 102. As discussed previously, at the position of the occluding hand, the doctor can hold each holding recess 322 of the catheter pusher base 318 to facilitate the advancement of the catheter pusher base 318. AsFigure 8E As shown, during the advancement of the catheter pusher base 318 and the catheter base 118, the needle support 142 continues to swing away from the paths of the catheter pusher base and the catheter base. Thus, the needle support 142 is moved out of the paths of the catheter pusher base 318 and the catheter base 118 to allow the distal end of the catheter pusher base 318 and the catheter base 118 to extend distally beyond the needle support 142. Thus, the catheter pusher base 318 and the catheter base 118 initially abut against the needle support 142, and once the catheter pusher base 318 causes the needle support 142 to swing upward to provide clearance for the complete deployment of the catheter assembly 102, the catheter pusher base 318 and the catheter base 118 move distally past the needle support 142, as Figure 8F shown. Thus, the catheter assembly advances distally such that the catheter assembly 102 is distal to the distal end of the handle 110. At this time, the needle safety clip 134 remains mounted at the rigid base cover 124, as described below.

[0104] Referring to Figure 9A , a perspective view of the needle safety clip 134 mounted at the rigid base 120 is shown. Referring to Figure 9B , a rear view of the needle safety clip 134 is shown. Referring to Figure 9C , a front view of the needle safety clip 134 is shown. The needle safety clip 134 includes a proximal sidewall 180 that includes a circular aperture 182 having a diameter slightly larger than the outer diameter of the needle cannula 130. In some embodiments, the circular aperture 182 may have a sharp inner surface to grip the outer surface of the needle cannula 130 when the needle cannula 130 is angled relative to the central axis of the circular aperture 182. In other words, when the needle cannula 130 is tilted relative to the needle safety clip 134, the sharp inner surface of the circular aperture 182 engages the outer surface of the needle cannula 130, as Figure 9D shown, to prevent movement of the needle cannula 130 relative to the needle safety clip 134.

[0105] Referring again to Figure 9A , a top wall 184 extends distally from the proximal sidewall 180 and defines a top opening 186. The top opening 186 allows the spring arm 188 to partially extend above the top wall 184 in its compressed state, as Figure 9AAs shown. The illustrated spring arm 188 has a C-shape. However, the spring arm 188 can be designed into other elastic shapes and can be formed, for example, into a stepped shape, a block shape, a serrated shape, or an irregular shape. The top distal portion of the spring arm 188 is connected to the distal bottom surface of the top wall 184 to fix the spring arm 188 to the rest of the needle safety clip 134. The spring arm 188 can be made of any flexible material, such as plastic, stainless steel, aluminum, or titanium. The spring arm 188 can be made of the same material as the rest of the needle safety clip 134 or of a different material with the desired properties.

[0106] The first distal wall 190 extends downward from the distal end of the top wall 184 and defines a first distal channel. The second distal wall 194 bends upward from the first distal wall 190 and defines a second distal channel. The narrow tab portion 198 extends distally from the distal end of the second distal wall 194, and the wide tab portion 200 extends distally from the narrow tab portion 198. The narrow tab portion 198 is received in the narrow recess 202 at the top of the rigid base cover 124, and the wide tab portion 200 is received in the wide recess 204 at the top of the rigid base cover 124 to mount the needle safety clip 134 to the rigid base cover 124. When the needle safety clip 134 is mounted to the rigid base cover 124, the narrow tab portion 198 prevents the lateral movement of the needle safety clip 134, while the wide tab portion 200 prevents the longitudinal movement of the needle safety clip 134.

[0107] Referring again to Figure 9C , the first distal wall 190 defines a channel having a circular top region 191 and a rectangular bottom region 192. The diameter of the circular top region 191 is slightly larger than the outer diameter of the needle cannula 130 to allow the needle cannula 130 to slide through the circular top region 191 with low friction and prevent the lateral movement of the needle cannula 130. The width of the rectangular bottom region 192 is smaller than the outer diameter of the needle cannula 130 to both maintain safety and avoid bouncing upward until the needle tip is located between the first distal wall and the second distal wall, and to block the needle cannula 130 from extending distally past the second distal wall 194, as will be explained in more detail below. The second distal wall 194 also includes a circular top region 195 and a rectangular bottom region 196 with a diameter larger than the outer diameter of the needle cannula 130. The width of the rectangular bottom region 196 can be equal to the diameter of the circular top region 195 to allow the needle cannula 130 to move downward relative to the needle safety clip 134 under the force of the spring arm 188.

[0108] Referring to Figure 9D, a perspective view of the needle safety clip 134 released from the rigid base 120 is shown. After the needle cannula 130 is withdrawn from the rigid base 120, the needle cannula passes proximally through the circular top region 195 of the second distal wall 194 and then through the circular top region 191 of the first distal wall 190. Once the circular top region 191 destabilizes the needle cannula 130 (i.e., once the width Wn of the sharp needle tip becomes smaller than the width of the rectangular bottom region 192), the needle safety clip 134 is free to tilt relative to the needle cannula 130. Then, as Figure 9D shown, the spring arm 188 expands to push the needle safety clip 134 upward. Since the needle cannula 130 is still within the circular hole 182, the needle cannula is caught by the sharp inner edge of the circular hole 182, which prevents the longitudinal movement of the needle cannula 130 relative to the needle safety clip 134. Thus, the first distal wall 190 and the second distal wall 194 cover the sharp needle tip 131 and protect the doctor from potential needle stick risks.

[0109] Referring to Figure 9E , a perspective view of the sharp needle tip 131 of the needle cannula 130 is shown. The sharp needle tip 131 can be formed by back grinding as shown, or in other embodiments, the sharp needle tip 131 can have a scalpel-shaped tip. The sharp needle tip 131 tapers in the distal direction such that the width W of the sharp needle tip at the plane along the sharp needle tip 131 n is equal to the width of the rectangular bottom region 192. Thus, when the needle safety clip 134 is released from the rigid base 120, the needle cannula 130 cannot extend distally beyond the first distal wall 190 beyond the plane where the sharp needle tip has width W n , because the needle cannula 130 is wider than the rectangular bottom region 192 proximal to this plane. However, the length L n can still extend distally beyond the first distal wall 190 because the needle cannula 130 is narrower than the rectangular bottom region 192 distal to this plane. Thus, as Figure 9F shown, to prevent the sharp needle tip 131 from being exposed beyond the second distal wall 194, the needle safety clip 134 is designed such that the distance D c along the axis aligned with the longitudinal axis of the needle cannula 130 between the first distal wall 190 and the second distal wall 194 is greater than the length L n .

[0110] As Figures 9A to 9FAs shown, the needle cannula 130 may further include a swaged portion 270 having a compressed area of metal tubing near the distal tip of the needle. The swaged portion may have a raised portion with a substantially oval or elliptical cross-section that is different from the circular cross-section of the remainder of the needle. The major diameter of the oval swaged portion 270 is less than the cut-away portions of the first distal sidewall 190 and the second distal sidewall 194 of the needle safety clip 134, but greater than the hole 182 in the proximal sidewall 180. This arrangement further ensures that the safety clip 134 is not pulled distally off the tip of the needle.

[0111] In addition, the minor diameter of the oval swaged portion is greater than the width of the cut rectangular bottom area 192 in the first distal sidewall of the needle safety clip. This ensures that even if the slot in the rectangular bottom area 192 of the needle safety clip is parallel to the swaged portion rather than perpendicular as in the normal state, the needle safety clip does not pop up when the swaged portion bypasses the first distal sidewall 190. In addition, the inner diameter of the swaged portion 270 is greater than the outer diameter of the guide wire 132 such that the guide wire 132 can pass therethrough.

[0112] Referring Figure 10A -10B, a partially transparent side view of the catheter insertion device 100 during separation of the catheter set 102 is shown. As described above in connection with Figure 8D As described, the slider 138 is initially slid proximally to provide clearance to allow the needle support 142 to swing upward, and then the release member 140 is slid distally to push the catheter pusher base 318 forward. Then, the doctor can fully advance the catheter into the patient, i.e., until the distal end of the catheter base 118 almost touches the skin. Then, the doctor uses the hand that is not holding the handle 110 to stabilize the catheter set 102. For example, the doctor can use their non-dominant hand to grasp the catheter base 118 and / or the rigid base 120 to hold the rigid base 120 in a constant position within the patient's blood vessel. Then, the doctor can pull the insertion set 104 proximally to remove the needle cannula 130 from the catheter set 102.

[0113] As Figure 10A shown, the insertion set 104 is pulled proximally to a position where the sharp needle tip 131 of the needle cannula 130 is proximal to the second distal sidewall 194 but still distal to the first distal sidewall 190. Thus, the plane of the sharp needle tip 131 having a width W n remains distal to the first distal sidewall 190, and the needle cannula 130 is stabilized within the circular top region 191. As Figure 10B shown, the width W of the sharp needle tip 131 nless than the width of the bottom region 192 of the rectangle, so that the needle safety clip can tilt freely relative to the needle cannula. Then, the spring arm 188 expands to tilt the needle safety clip upward so that the second distal side wall 194 and / or the first distal side wall 190 cover the sharp needle tip 131.

[0114] Referring to Figure 11A , a perspective view of an embodiment of the seal 218 is shown. The seal 218 is a two-piece seal including a proximal portion 220 and a distal portion 222. Referring to Figure 11B , the proximal portion 220 has a flat proximal face 224 and a proximal region 228 with a reduced diameter. The proximal portion 220 defines an internal cavity 230 that extends mostly along the longitudinal axis of the proximal portion 220. Relative to the seal 211, the internal cavity 230 reduces the surface area of the seal 218 in contact with the needle cannula 130, thereby reducing the frictional forces applied during the advancement of the catheter set and during the removal of the needle cannula 130. According to another aspect, a lubricant can be added to the internal cavity 230 to further reduce these frictional forces. Additionally, during the useful life of the device (i.e., before the cannula is removed), the cavity 230 also provides a void space for the volume of seal material transferred when the cannula is inserted into the seal for the seal material to move into. This can prevent a small portion of the seal material from migrating out of the back of the rigid cap of the catheter or distally into the catheter, i.e., into the rigid catheter base.

[0115] Referring to Figure 11C , the distal portion 222 is solid and includes a proximal region 232 with a reduced diameter. The diameter of the proximal region 232 is slightly smaller than the diameter of the internal cavity at the distal end of the proximal portion 220 to prevent lateral movement of the distal portion 222 relative to the proximal portion 220 when the seal 218 is assembled within the rigid base 120 and the rigid base cap 124. The distal portion 222 also has a tapered distal region with a diameter that decreases distally. The seal 218 can be made of an elastic material, such as silicone, rubber, polyisoprene, and the like.

[0116] Referring to Figure 11D , a partial cross-sectional view of the assembled rigid base 120, the two-piece seal 218, and the rigid base cap 124 taken along a plane defined by the diameter of the rigid base 120 and the longitudinal axis of the side port portion 121 is shown. The proximal region 228 with a reduced diameter is compressed within the rigid base cap 124 to radially inwardly press the seal material in response to the pressure applied on the flat distal face 226. The flat distal face 226 can be flush with the distal end of the rigid base cap 124 to allow for complete evacuation of the internal volume of the rigid base 120 when the flush catheter is inserted into the device 100.

[0117] As Figure 11DAs shown, the diameter of the distal seal is greater than the diameter of the mating cavity in the rigid base. This helps generate a compressive force to prevent air or fluid leakage after the needle / cannula is removed by a doctor during the normal use of the catheter (e.g., blood drawing or fluid injection). In addition, the portion of the distal seal that is made to have rounded corners (in the middle of the assembly) mates with the corresponding radius on the inside of the rigid cap to facilitate the placement and positioning of the distal seal and to resist the pressure from the extension line and the distal end inside the catheter body to keep the seal in place. The additional compressive force on the proximal side of the seal further closes the previous hole from the cannula. Also, the proximal side of the seal can be flush with the outside of the rigid cap or slightly beyond flush to allow the base to be cleaned.

[0118] Referring Figure 12 , a perspective view of the distal region of the needle cannula 130 is shown. The distal region of the needle cannula 130 includes one or more echo features, preferably eight echo features. For example, the echo features can be through holes 258 drilled inside the opposite sides of the needle cannula 130. Although the sharp needle tip 131 is echogenic when observed under ultrasound, the through holes 258 improve the echogenicity of the needle cannula 130. In particular, the through holes 258 are visible through the wall thickness of the elongate catheter 106 under ultrasound. In addition, the through holes 258 allow blood to flow from the lumen of the needle cannula 130 to the outer surface of the needle cannula. Then, the blood flows to the inner surface of the catheter 106 to allow visual observation of the blood.

[0119] The through holes 258 are angled with respect to each other. For example, the through holes 258 are drilled 90 degrees apart from each other, as Figure 12 shown. The different angles and the number of the through holes 258 result in at least two echo features being always visible under ultrasound - one echo feature is the sharp needle tip 131, and the other echo feature is at least one of the through holes 258. These two visible echo features enable the doctor to know the insertion angle of the needle cannula 130.

[0120] Many features and advantages of the catheter insertion device 100 are apparent from the detailed description herein. Accordingly, the claims cover all such features and advantages within the scope of this application. In addition, many modifications and variations are possible. Thus, it is not desired to limit the catheter insertion device 100 to the exact construction and operation described and shown. Accordingly, all suitable modifications and equivalent substitutions may fall within the scope of the appended claims.

Claims

1. A catheter insertion device, the catheter insertion device comprises: a handle having a main body portion, a top arm extending distally from the main body portion, and a bottom arm extending distally from the main body portion; a needle cannula having a proximal end located within the main body portion of the handle and a sharp distal tip extending distally from the top arm and the bottom arm; a catheter assembly detachably coupled to the handle and configured to be slidable over the needle cannula, the catheter assembly having a portion disposed in a space between the top arm and the bottom arm, the catheter assembly including an elongate catheter, a catheter base connected to the elongate catheter, and a catheter pusher base releasably connected to the catheter base, the catheter pusher base being slidably disposed between the top arm and the bottom arm, the catheter pusher base having a grip portion configured to enable the catheter assembly to be held and to advance the catheter assembly from a first position to a second position; a guide wire partially disposed within the handle; a guide wire actuator connected to the handle and to the guide wire, the guide wire actuator being configured to slide along the top arm of the handle to move the guide wire relative to the handle.

2. The catheter insertion device according to claim 1, wherein, the catheter pusher base includes a pair of laterally extending grip arms configured to assist a user in gripping the catheter assembly.

3. The catheter insertion device according to claim 2, wherein, the catheter pusher base further includes a seat portion configured to fix the catheter and the catheter base to the catheter pusher base.

4. The catheter insertion device according to claim 3, wherein, the seat portion of the catheter pusher base includes a pair of spaced fasteners for fixing the catheter pusher base to the catheter base, whereby during catheter insertion when the catheter pusher base is advanced distally, the catheter base remains connected to and moves with the catheter pusher base.

5. The catheter insertion device according to claim 2, wherein, the catheter pusher base further includes a retaining member configured to fix the catheter base to the catheter pusher base, whereby during catheter insertion when the catheter pusher base is advanced distally, the catheter base remains connected to and moves with the catheter pusher base.

6. The catheter insertion device according to claim 5, wherein, the proximal end of the guide wire is connected to the guide wire actuator.

7. The catheter insertion device according to claim 6, wherein, the top arm of the handle includes a groove, and the guide wire actuator includes a portion disposed in the groove to guide the guide wire actuator as it slides along the top arm of the handle, thereby extending or retracting the guide wire relative to the handle.

8. The catheter insertion device according to claim 1, wherein, The catheter pusher base is configured to prevent the catheter assembly from twisting during movement of the catheter assembly from the first position to the second position.

9. The catheter insertion device according to claim 8, wherein, the catheter pusher base is configured to be slidable along the bottom arm of the handle.

10. The catheter insertion device according to claim 9, wherein, the catheter pusher base includes a guiding portion configured to receive the bottom arm of the handle for guiding the catheter assembly from the first position to the second position.

11. The catheter insertion device according to claim 1, wherein, the catheter insertion device further includes a needle support member connected to the handle and movable between a closed position and an open position, the needle support member being configured to block the distal advancement of the catheter assembly when the needle support member is in the closed position, and the needle support member being further configured to allow the distal advancement of the catheter assembly when the needle support member is in the open position.

12. The catheter insertion device according to claim 11, wherein, the needle support member is further configured to stabilize the lateral movement of the needle cannula during insertion when the needle support member is in the closed position.

13. The catheter insertion device according to claim 11, wherein, the needle support member has a pair of parallel walls pivotally connected to the handle, and the needle support member is configured to support the needle cannula when the needle support member is in the closed position.

14. The catheter insertion device according to claim 13, wherein, when the needle support member is in the closed position, the needle cannula is disposed between the pair of parallel walls of the needle support member.

15. The catheter insertion device according to claim 11, wherein, the needle support member cannot move from the closed position to the open position until the guide wire actuator is moved to extend the guide wire distally relative to the handle.

16. The catheter insertion device according to claim 11, wherein, when the needle support member is in the closed position, the guide wire pusher abuts against the needle support member, and when the needle support member is in the open position, the guide wire pusher does not abut against the needle support member.

17. The catheter insertion device according to claim 11, wherein, the needle support member is pivotally connected to the distal portion of the top arm of the handle, and the needle support member is configured to move relative to the handle when the catheter pusher base abuts against the needle support member.

18. The catheter insertion device according to claim 1, wherein, the catheter insertion device further includes a catheter assembly actuator connected to the handle, the catheter assembly actuator being movable relative to the handle to slide the catheter assembly distally relative to the handle.

19. The catheter insertion device according to claim 1, wherein, the guide wire further has a variable stiffness.

20. The catheter insertion device according to claim 1, wherein, The housing of the catheter insertion device further includes a gripping surface that facilitates a user to operate the catheter insertion device with one hand.

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