Continuously Visible Flashback Catheter Insertion Device

Abstract

To provide a catheter insertion apparatus having a hollow needle body connected to a needle hub, and a catheter that removably fits over the needle body.SOLUTION: In a catheter insertion apparatus, a needle body has a sharp distal needle tip for piercing a blood vessel wall. An internal flow passage of the needle hub is in fluid communication with the hollow needle body. An elongated housing is connected to the needle hub and has a lumen in fluid communication with the internal flow passage of the needle hub. An integrated guide assembly is slidably mounted to the housing and is operable to move between a retracted position and an extended position. A flashback chamber is operable to receive a continuous flow of blood before, during, and after movement of the guide assembly between its retracted and extended positions. A safety guard may provide protection from the sharp needle tip.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to catheter insertion devices, and more particularly to an integrated over-the-needle catheter insertion device operable to provide continuous blood flush visibility during catheter insertion.

[0002] REFERENCE TO RELATED APPLICATIONS This application is a claim of U.S. Provisional Patent Application No. 62 / 833,477, filed April 12, 2019, the disclosure of which is incorporated herein by reference. [Background technology]

[0003] Catheters are commonly used to withdraw or introduce fluids into a patient's blood vessels for various medical procedures. For example, radial artery catheterization may be performed to provide access to the arterial system via the radial artery for blood pressure monitoring or blood withdrawal. Catheters are often inserted into the vascular system via an integrated catheter insertion device. In a typical catheter insertion procedure, for example, to insert a catheter into a blood vessel, vascular access is first achieved by puncturing the vessel wall with a long, hollow needle. A guidewire is then threaded through the needle and into the vascular system. The guidewire serves as a track for passing the catheter to reach the target location within the blood vessel. Finally, the catheter is advanced over the guidewire to the target location within the patient's vascular system. With the catheter in place, the needle and guidewire are removed, leaving only the catheter in the blood vessel. Fluids can then be introduced into or removed from the blood vessel via the catheter by connecting a fluid source or suction device to the catheter hub.

[0004] Conventional catheter insertion devices provide a means for the physician to visualize blood flushing to indicate when the needle tip has entered the vascular system through vascular puncture. Some known catheter insertion devices offer the ability for the user to visualize blood flushing within the wire advancement tube during vascular puncture after puncturing a pressurized blood vessel, e.g., an artery, thereby allowing blood to flow through the inner diameter of the needle and then out an exit location located at or near the rear of the needle into a wire tube located proximal to the catheter body portion of the catheter insertion device. These devices allow the physician to reconfirm vascular puncture, if necessary, because the blood flushing can start, stop, and resume as the distal needle tip enters, exits, and re-enters the blood vessel during insertion. However, such devices do not allow for (1) visible blood flushing through the catheter body, or (2) confirmation of blood flushing within the device (i.e., the wire tube) during and after wire advancement.

[0005] Instead, blood flushing in conventional catheter insertion devices stops during and after subsequent wire advancement because the wire occupies too much volume within the needle, thus reducing flow. Furthermore, if the wire used in conventional devices begins advancement distal to the needle flush exit location, it will again occupy too much volume, thereby reducing blood flush flow. Therefore, the wire must begin advancement proximal to the blood flush exit location near the back of the needle; thus, the first significant portion of wire advancement results in the wire moving through the catheter from the back of the needle (located proximal to the catheter body) to the tip of the needle (located distal to the catheter body), which then advances the wire into the blood vessel, also known as the "dead length" of wire advancement (i.e., the amount of advancement that moves the tip of the wire near the needle tip before advancing the wire out of the needle). Such dead wire length is a common drawback of conventional devices because it prolongs the catheter insertion procedure by creating a significant time between observing the flush and advancing the wire into the vessel, during which time a continuous visible blood flush (and thus information regarding needle tip placement) is unavailable with conventional devices.

[0006] Other conventional catheter insertion devices offer the user the ability to visualize a blood flush through a transparent or partially translucent catheter during vascular puncture when blood enters the small volume between the inside of the hollow catheter and the outside of the hollow needle. While these devices allow the flush to be seen through the catheter as it enters this small volume, in practice, the flush is considered a one-time event because such devices do not offer the ability to initially observe the flush and then resume flushing after it very quickly fills this small volume. This aspect makes it difficult for a physician to retry an insertion that results in the needle tip becoming misaligned with or penetrating the blood vessel. Summary of the Invention [Problem to be solved by the invention]

[0007] Thus, conventional catheter insertion devices do not allow for 1) visible blood flash through the catheter body, and / or 2) confirmation of blood flash within the device (i.e., wire tract, etc.) during and after wire advancement. Accordingly, there is a need for a novel catheter insertion device that allows for continuous visible blood flashback during insertion of the catheter into a patient's blood vessel. Specifically, there is a need for a catheter insertion instrument that provides the ability to visualize the flash through the catheter and within the device (i.e., wire tract, etc.) (which also includes the ability to review the flash within the wire tract, etc.), and that also provides the ability to visualize the flash during and after wire advancement.

[0008] There is also a need for a catheter insertion instrument that provides the ability to visualize flash within the wire tract, etc. (which also includes the ability to reconfirm flash within the wire tract, etc.), and also the ability to begin advancing the wire guide inside the needle and near the needle tip, both of which reduce wire reach and reduce dead wire advancement length to improve ease and speed of catheter insertion.

[0009] Additionally, there is a need for a catheter insertion instrument that provides the ability to visualize flush within the wire advancement tube, etc. (which also includes the ability to review flush within the wire tube, etc.), and also the ability to separate the wire advancement portion of the wire tube from the blood flush chamber portion of the wire tube (thereby reducing the risk of blood exposure during insertion and cross-contamination of the outer portion of the wire with blood from the blood flush).

[0010] Additionally, there is a need for a catheter insertion device that allows for intuitive, easy, safe, and rapid placement of a catheter into a patient's vascular system. [Means for solving the problem]

[0011] The above needs are largely met by the inventive catheter insertion instrument described herein, which includes a needle including a needle body connected to a needle hub, the needle body having a longitudinal bore and a distal needle tip configured to puncture a wall of a blood vessel, the needle hub having an internal flow passage in fluid communication with the longitudinal bore of the needle body, the catheter insertion instrument further includes a catheter configured to removably fit over the needle body, the catheter including the catheter body connected to the catheter hub, the catheter insertion instrument further includes a housing including an elongated housing body connected to the needle hub, the elongated housing body having an elongated lumen in fluid communication with the internal flow passage of the needle hub. The catheter insertion instrument further includes a guide assembly slidably mounted to the housing body, the guide assembly including a guidewire having a distal guidewire tip, the guidewire movable between a retracted position in which the distal guidewire tip is disposed within the needle body and an extended position in which the distal guidewire tip is disposed outside the needle body, and a continuous flashback chamber defined by the elongated lumen of the housing body and the internal flow path of the needle hub, the continuous flashback chamber configured to provide visualization of continuous blood flow during insertion of the distal needle tip into a blood vessel.

[0012] In accordance with another aspect of the present invention, the continuous flashback chamber can accommodate a continuous flow of blood during insertion of the distal needle tip into the blood vessel when the guidewire is in the retracted position, when the guidewire is in the extended position, and during movement of the guidewire between the retracted and extended positions.

[0013] In accordance with another aspect of the invention, a flow diverter is configured to divert blood flow from the internal flow path of the needle hub into the elongated lumen of the housing body.

[0014] According to another aspect of the invention, the flow diverter includes a throughbore configured to slidably receive a guidewire.

[0015] In accordance with another aspect of the invention, the flow diverter forms a seal with a portion of the distal end of the housing body, the seal restricting blood flow from leaking out of the housing.

[0016] In accordance with another aspect of the present invention, the guide assembly further includes an actuator coupled to the proximal end of the guidewire, the actuator being movable relative to the housing and needle to correspondingly move the guidewire between retracted and extended positions relative to the housing and needle.

[0017] According to another aspect of the invention, the actuator includes a collar configured to be slidably mounted to the housing body.

[0018] According to another aspect of the invention, the actuator further includes a handle coupled to the collar for manually sliding the collar along the longitudinal length of the housing body.

[0019] According to another aspect of the invention, the housing body further includes an annular band configured to abut the collar of the actuator when the guidewire is in its retracted position.

[0020] According to another aspect of the invention, the actuator further includes a slide member extending inwardly from the collar, the slide member having a neck portion and a head portion.

[0021] In accordance with another aspect of the invention, the proximal end of the guidewire is coupled to the head portion of the sliding member.

[0022] According to another aspect of the invention, the housing body further includes a longitudinal track configured to slidably receive the head portion of the slide member.

[0023] According to another aspect of the invention, the housing body further includes a longitudinal slot configured to slidably receive the neck portion of the slide member.

[0024] In accordance with another aspect of the invention, the actuator further includes markings configured to mate with corresponding indicia along the housing body to indicate the distance traveled by the guidewire into the blood vessel during the insertion procedure.

[0025] In accordance with another aspect of the invention, the housing body is generally tubular.

[0026] According to another aspect of the invention, the housing body has a substantially crescent-shaped cross section.

[0027] In accordance with another aspect of the present invention, the housing body and needle hub are made of a transparent or translucent material.

[0028] In accordance with another aspect of the present invention, a rapid flashback chamber is configured to provide visualization of the initial flow of blood upon insertion of the distal needle tip into a blood vessel.

[0029] In accordance with another aspect of the invention, a rapid flashback chamber is formed between the needle body and the catheter body, the needle body having a side port for directing the initial flow of blood into the rapid flashback chamber.

[0030] According to another aspect of the invention, a vent plug is coupled to the proximal end of the housing body and configured to prevent leakage of blood from the lumen of the housing body.

[0031] According to another aspect of the invention, the needle hub further includes a safety guard configured to provide sharps protection for the distal needle tip.

[0032] In accordance with another aspect of the present invention, a catheter insertion instrument includes a needle body having a longitudinal bore and a sharp distal needle tip configured to puncture a wall of a blood vessel, and a needle hub coupled to the needle body, the needle hub having an internal flow passage in fluid communication with the longitudinal bore of the needle body, the catheter insertion instrument further includes a catheter configured to removably fit over the needle body, the catheter including a catheter body coupled to the catheter hub, the catheter insertion instrument further includes a housing including an elongated housing body coupled to the needle hub, the elongated housing body having a lumen in fluid communication with the internal flow passage of the needle hub, the catheter insertion instrument includes a distal guide wire received within the housing body. the catheter insertion instrument further comprises a guidewire having a needle tip, the guidewire being movable between a retracted position in which the distal guidewire tip is disposed within the needle body and an extended position in which the distal guidewire tip is disposed outside the needle body; the catheter insertion instrument further comprises a continuous flashback chamber defined by the lumen of the housing body and the internal flow path of the needle hub, the continuous flashback chamber being capable of receiving a continuous flow of blood before, during, and after movement of the guidewire between its retracted and extended positions; and the catheter insertion instrument further comprises a safety guard removably received within the needle hub and configured to provide sharps protection for the distal needle tip.

[0033] According to another aspect of the invention, the elongate housing body further includes an elongate guidewire track configured to receive a guidewire.

[0034] In accordance with another aspect of the invention, a flow diverter is configured to divert blood flow from the internal flow path of the needle hub into the elongated lumen of the housing body and further configured to prevent blood from leaking into the guidewire track.

[0035] According to another aspect of the invention, the flow diverter includes a throughbore configured to slidably receive a guidewire.

[0036] According to another aspect of the present invention, an actuator is coupled to the proximal end of the guidewire, the actuator having a sliding member with a portion configured to be slidably mounted within a track in the housing body, and the actuator can move the guidewire between a retracted position and an extended position.

[0037] According to another aspect of the invention, the housing body has a substantially crescent-shaped cross section.

[0038] In accordance with another aspect of the present invention, a rapid flashback chamber is formed between the needle body and the catheter body, the rapid flashback chamber configured to provide visualization of the initial flow of blood upon insertion of the distal needle tip into a blood vessel.

[0039] According to another aspect of the invention, the safety guard includes a safety cartridge and a safety cap that cooperate to define an internal cavity, and the safety cartridge and the safety cap are configured to slide over the needle body and along the needle body toward the distal needle tip to receive the distal needle tip within the internal cavity.

[0040] In accordance with another aspect of the present invention, a pivotable latch is disposed within the interior cavity, the pivotable latch having a distal opening and a proximal opening, both of which are sized to allow the needle body to pass therethrough.

[0041] In accordance with another aspect of the present invention, a biasing member is configured to bias the pivotable latch into locking engagement with the needle body, thereby preventing withdrawal of the distal needle tip from the internal cavity when the distal needle tip is positioned within the internal cavity.

[0042] According to another aspect of the invention, the biasing member comprises a spring configured to bias the pivotable latch to tilt about the needle body.

[0043] Thus, certain embodiments of the invention have been outlined generally in order that the detailed description of this disclosure may be better understood, and in order that the present contribution to the art may be better appreciated. Additional embodiments of the invention exist that are described below and form the subject matter of the claims appended hereto.

[0044] In this regard, before describing at least one aspect of the catheter insertion instrument in detail, it should be understood that the catheter insertion instrument is not limited in its application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The catheter insertion instrument can provide aspects in addition to those described and can be embodied and implemented in various forms. It should also be understood that the phraseology and terminology used herein, as well as the descriptions in the Abstract, are for purposes of explanation and should not be construed as limiting the invention.

[0045] As such, it will be appreciated by those skilled in the art that the teachings underlying this invention may be readily utilized as a basis for the design of other structures, methods, and systems for carrying out the several purposes of the catheter insertion device. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.

[0046] In order that the present invention may be readily understood, various aspects of a catheter insertion device are shown by way of example in the accompanying drawings, in which like parts are designated by like reference numerals throughout the specification. [Brief explanation of the drawings]

[0047] [Figure 1] 1 is a perspective view of a catheter insertion instrument according to an embodiment of the present invention; [Figure 2] FIG. 2 is a side view of the catheter insertion instrument of FIG. 1. [Figure 3] FIG. 2 is a plan view of the catheter insertion instrument of FIG. 1. [Figure 4A] 1 is a cross-sectional side view of a guide assembly of the catheter insertion device of the present invention. [Figure 4B] 1 is a cross-sectional side view of a housing assembly of the catheter insertion device of the present invention. [Figure 4C] 1 is a cross-sectional side view of a needle assembly of the catheter insertion device of the present invention. [Figure 4D] 1 is a cross-sectional side view of a catheter of the catheter insertion device of the present invention. [Figure 5A] 5A is a cross-sectional side view of the catheter insertion instrument in the retracted position taken along line 5A-5A of FIG. 3. [Figure 5B] FIG. 5B is a cross-sectional side view of the catheter insertion instrument of FIG. 5A in an extended position. [Figure 6] FIG. 2 is an enlarged side view of the actuator of the catheter insertion instrument of the present invention. [Figure 7] 7 is a cross-sectional front view of the actuator taken along line 7-7 of FIG. 6. [Figure 8A] FIG. 1 is a front perspective view of a flow diverter of the catheter insertion device of the present invention. [Figure 8B] FIG. 8B is a rear perspective view of the flow divider shown in FIG. 8A. [Figure 9] 1 is a plan view of a portion of a catheter insertion device of the present invention. [Figure 10] FIG. 5B is an enlarged cross-sectional side view of the portion of the catheter insertion instrument shown in the box in FIG. 5A, illustrating the distal end of the catheter insertion instrument of the present invention. [Figure 11] FIG. 5B is an enlarged cross-sectional side view of the portion of the catheter insertion instrument shown in the box in FIG. 5A, showing the proximal end of the needle assembly and the distal end of the housing. [Figure 12A] FIG. 1 is an enlarged plan view of an embodiment of the distal needle tip of the present invention. [Figure 12B] FIG. 10 is an enlarged plan view of another embodiment of the distal needle tip of the present invention. [Figure 13A] FIG. 1 is a top perspective view of an embodiment of the blood containment and vent plug of the present invention. [Figure 13B] FIG. 13B is a bottom perspective view of the blood containment and vent plug of FIG. 13A. [Figure 13C] FIG. 10 is a top perspective view of another embodiment of the blood containment and vent plug of the present invention. [Figure 14] 10 is a cross-sectional side view of a catheter insertion device having a needle guard according to another embodiment of the present invention. [Figure 15A] FIG. 15 is an enlarged cross-sectional side view of the needle guard of FIG. 14 in an unlocked position. [Figure 15B] FIG. 15 is an enlarged cross-sectional side view of the needle guard of FIG. 14 in the locked position. DETAILED DESCRIPTION OF THE INVENTION

[0048] As described in detail herein, the present disclosure relates to an integrated over-the-needle catheter insertion device capable of providing continuous blood flush visibility during catheter insertion. The catheter insertion device can provide continuous blood flush visibility (i.e., flush through the catheter, flush within the wire lumen, ability to review the flush within the wire lumen, and ability to view the flush within the wire lumen both during and after wire guide advancement). The catheter insertion device can also provide continuous blood flush visibility while initiating wire guide tip advancement within and near the wire tip, without causing undue blood exposure and without adversely affecting other important aspects of the insertion procedure. Thus, the catheter insertion device of the present invention improves insertion success rates and increases the physician's confidence in knowing that the needle tip is positioned within the bloodstream throughout the insertion procedure without undue blood exposure. The catheter insertion device of the present invention can be utilized for catheterization of various blood vessels, including the radial artery or other arterial vessels, as well as the venous vasculature. Additionally, the catheter insertion device of the present invention can be utilized to insert other catheters, such as introducer-type catheters used to facilitate the insertion of a PICC (peripherally inserted central catheter) or CVD (central venous catheter) or other vascular access device.

[0049] 1-3 illustrate a catheter insertion device 10 according to an embodiment of the present invention. The catheter insertion device 10 includes an over-the-needle catheter 20, a needle 30, a housing 40, and a movable integrated guide assembly 50. The catheter insertion device 10 is configured to provide continuous blood flush visibility during catheter insertion, including before, during, and after movement of the guide assembly 50.

[0050] The catheter 20 has a distal catheter end 20a and a proximal catheter end 20b. The needle 30 similarly has a distal needle end 30a and a proximal needle end 30b. The proximal end 20b of the catheter 20 is configured to fit over the distal end 30a of the needle 30 when assembled together. The catheter 20 and the needle 30 cooperate to form a first or rapid blood flashback chamber 24, as described in detail below. The housing 40 or wire tube has an elongated, generally tubular body 42 having a distal housing end 42a and a proximal housing end 42b. The housing body 42 has a longitudinal groove or channel defining an elongated guidewire track 43 configured to cooperate with the guide assembly 50. The guidewire track 43 extends from the distal housing end 42a to the proximal housing end 42b of the housing body 42. Housing body 42 further includes a longitudinal lumen 44 that cooperates with needle hub 32 of needle 30 to define a second or continuous blood flashback chamber. Guidewire track 43 and the portion of the second flashback chamber extending from distal end 42a to proximal end 42b of housing body 42 may also extend substantially parallel to one another.

[0051] The distal end 42a of the housing body 42 is secured to the proximal end 30b of the needle 30. In some cases, the needle assembly 30 may be removably coupled to the housing 40. In other cases, the needle assembly 30 may be integral with the housing 40. The distal end 42a of the housing body 42 is coupled to a flow diverter 60 configured to direct blood into the second flashback chamber and away from the guidewire track 43, thereby providing a visible, continuous or uninterrupted blood flush within the second flashback chamber. The proximal end 42b of the housing body 42 is sealed by a removable blood containment and vent plug 70, as described in further detail below. The guide assembly 50 includes an actuator 52, e.g., a slider, coupled to the proximal end 59b of the guidewire 59. The guide assembly 50 is configured to move along the longitudinal length of the housing 40 in response to sliding the actuator 52.

[0052] 4A-4D, each of the above-mentioned components of the catheter insertion device 10 are shown separately prior to assembly for illustrative purposes. Specifically, FIG. 4A shows the guide assembly 50, including the guidewire 59 and its actuator 52. FIG. 4B shows the main body 42 of the housing 40, which receives the guidewire 59 and slidably carries its actuator 52. The housing main body 42 is coupled to the needle 30, shown in FIG. 4C, which in this case has a needle hub 32 and a hollow needle body 36. The needle 30 carries an over-the-needle catheter 20, as shown in FIG. 4D, which in this case has a catheter hub 22 and a catheter body 26.

[0053] 5A, a cross-sectional view of the catheter insertion device 10 is shown in its assembled state prior to assembly, in which the housing 40 removably carries the catheter 20 on the needle 30 in an over-the-needle position, and the guide assembly 50 is in its normally retracted position. In this retracted position, the distal end 59a of the guidewire 59 is disposed within the needle body 36. The needle 30 is of a length relative to the catheter 20 such that the distal end 30a of the needle assembly 30 extends beyond the distal end 20a of the catheter 20 when the catheter 20 is secured onto the needle 30.

[0054] 5B shows a cross-sectional view of the catheter insertion device 10 during a catheter insertion procedure, with the guide assembly 50 in its fully extended position to guide the insertion of the catheter body 26 into a blood vessel. The needle 30 is coupled to the housing body 42, which also carries the actuator 52 of the guide assembly 50. The actuator 52 is shown moved along the length of the housing body 42 to distally advance the guidewire 59 from its normally retracted position to its extended position. The actuation handles or wings 53 are positioned so that a user can manipulate the actuation handles or wings 53 by placing the catheter body 26 into a blood vessel with their thumbs while grasping the housing 40 and / or needle 30 to facilitate either one-handed or two-handed actuation of the device 10. Furthermore, the flexible portion of the catheter 20 allows the catheter to bend without kinking, i.e., to a large angle after insertion into the vasculature. Additionally, auxiliary devices, such as valves or tubing, may be connected to the catheter hub 22 after insertion into the vascular system.

[0055] Referring back to FIG. 4A , the distal end 59a of the guidewire 59 has a rounded tip, e.g., a hemispherical tip, to minimize or prevent trauma to the blood vessel during insertion. The proximal end 59b of the guidewire 59 is securely attached to the actuator 52. The actuator 52 has a cylindrical collar 54 configured to slide over the tubular body 42 of the housing 40. A handle or wing 53 is coupled to the collar 54 for moving the actuator 52 and guidewire 59 along the length of the housing body 42. The handle 53 may be ergonomically shaped and may further include a non-slip surface, e.g., ridges or bumps, to provide a non-slip grip. A sliding member 55 is also coupled to the cylindrical collar 54 and configured to slide within the longitudinal groove 43 of the housing body 42.

[0056] 6 and 7, the relationship between the actuator 52 and the housing body 42 is shown. Specifically, the housing body 42 has a generally round outer wall 45 configured to cooperate with a cylindrical collar 54 and a generally oval inner or dividing wall 46 that defines a longitudinal groove 43 and is configured to slidably receive a sliding member 55. The outer and inner walls 45 and 46 further define a longitudinally extending lumen 44 that cooperates with the needle hub 32 to define a second flashback chamber. Furthermore, contiguous portions of the outer and inner walls 45 and 46 define a longitudinal slot 47 that extends parallel to and alongside the longitudinal guidewire track 43. In some cases, the lumen 44 may have a substantially crescent-shaped cross-section defined by the outer and inner walls 45 and 46. Both the outer and inner walls 45 and 46 may be transparent or translucent to allow for easy visualization of the blood flash within the flashback chamber. Centrally within housing body 42, inner or dividing wall 46 is shaped to provide a longitudinally extending central track 43 for receiving a spherical head 56 of slide member 55. Additionally, outer wall 45 of body 42 defines a slot 47 that is coextensive with and defines an opening for track 43. Slot 47 is in communication with track 43 and is also configured to receive neck 57 of slide member 55 to secure the actuator to the housing body and prevent rotation of the actuator about the housing.

[0057] 4B and 4C, the housing body 42 has a distal end 42a and a proximal end 42b. The lumen 44 and guidewire track 43 open through the proximal end 42b of the housing body 42. The open end of the lumen 44 at the distal end 42a of the housing body 42 cooperates with the internal flow path of the needle hub 32 to form a continuous flashback chamber. The proximal end 42b of the lumen 44 of the housing body 42 is closed to prevent blood flow by a porous blood containment and vent plug 70 configured to allow purging of air.

[0058] As described above, the needle 30 has a distal end 30a and a proximal end 30b, and includes a needle hub 32 and a needle body 36. The needle hub 32 has a distal end 32a and a proximal end 32b, and the needle body 36 has a sharp, beveled distal tip 36a and a proximal end 36b. The needle hub 32 may be transparent or translucent to allow visualization of blood within the needle hub. Additionally, a fluid passage extends through the needle hub 32, the fluid passage including a narrowed portion 33 and a countersunk portion 34. An internal cavity 35 is provided at the proximal end 32b of the needle hub and is configured to receive a portion of the distal end 42a of the housing body 42. The countersunk portion 34 of the fluid passage is located between the narrowed portion 33 and the internal cavity 35, through which fluid passes.

[0059] The needle body 36 has an internal lumen or bore 36c extending from its distal tip 36a to its proximal end 36b. The needle body has at least one side port 37 configured to allow blood flow into the rapid blood flashback chamber 24. The proximal end 36b of the needle body 36 is fixedly secured to the distal end 32a of the needle hub 32 such that the internal needle bore 36c is in fluid communication with the internal flow passage including the narrowed portion 33 and the countersunk portion 34. Furthermore, the internal flow passage of the needle hub cooperates with the lumen 44 of the housing body 42 to define a continuous blood flashback chamber. The needle hub 32 may further include a gripping member 39, such as a protruding rib, to assist the user in gripping the needle assembly 30 during the insertion procedure.

[0060] FIG. 4D shows a catheter 20 having a distal end 20a and a proximal end 20b. The catheter assembly 20 further includes a catheter hub 22 and a catheter body 26, the catheter body 26 having a distal tip 26a and a proximal end 26b. The catheter body 26 further has an internal lumen or bore 26c extending from the distal tip 26a to the proximal end 26b. When the catheter insertion device 10 is assembled, the distal end 42a of the housing body 42 is securely fitted within the proximal end 32b of the needle hub 32, and the catheter 20 is placed over the needle body 36 of the needle assembly 30. The elongated lumen 44 of the housing 40 is in fluid communication with the needle bore 36c through a fluid communication relationship with the internal flow passage of the needle hub 32. The distal tip 26a of the catheter body 26 may have a gradually decreasing cross-section or taper to facilitate insertion into a blood vessel. Additionally, the catheter body 26 is supported at its proximal end 26b by the catheter hub 22, which in some embodiments may have laterally projecting suture wings (not shown), although it should be understood that the catheter hub 22 may include other means for retaining the catheter assembly 20 relative to the patient after placement within the blood vessel.

[0061] A flow diverter 60 having distal and proximal ends 60a, 60b is provided within the distal end 42a of the housing body 42 and within the proximal end 32b of the needle hub 32, which closes the distal end 42a of the guidewire track 43. As shown in FIGS. 8A and 8B, the distal end 60a of the flow diverter has a sloped surface 62 configured to divert fluid flow from the internal flow path of the needle into the lumen 44 of the housing assembly 40. The flow diverter 60 further has a passageway or through-hole 64 configured to allow the guidewire 59 to slidably pass therethrough without interrupting fluid communication between the needle bore 36c and the lumen 44. As a result, blood flashback into the second flashback chamber is continuous despite movement of the guidewire along the length of the housing and needle.

[0062] Specifically, passageway 64 is formed by a wire-receiving opening extending from distal end 60a to proximal end 60b, through which guidewire 59 is threaded to permit longitudinal movement relative to housing 40. The fit between guidewire 59, which may have a uniform diameter, and passageway 64 is such that it does not interfere with easy sliding movement of guidewire 59, while at the same time not blocking or minimizing blood flow through the passageway and into guidewire track 43. This is accomplished because proximal end 60b of flow diverter 60 is configured to fit snugly within guidewire track 43 at distal end 42a of housing body 42, such that track 43 is closed at distal end 42a of housing body 42.

[0063] The guidewire track 43 remains open at the proximal end 42a of the body 42 and along its bottom surface via a longitudinally extending, coextensive slot 47 centrally located in the outer wall 45 of the housing body 42. The distal surface 60a of the flow diverter 60 thus diverts flashback blood flow into the adjacent lumen portion 44 of the continuous flashback chamber at the distal end 42a of the housing body 42. The flow diverter restricts blood flow into the guidewire track 43, thereby minimizing, if any, leakage of blood through the flow diverter passage 64 into the guidewire track 43. Additionally, other configurations of the flow diverter may include a silicone seal that forms a duckbill-type seal that creates a tight seal around the wire and achieves a similar fluid-tight seal.

[0064] In some embodiments, a continuous flashback chamber can be used to enable catheterization procedures into the venous system as well as the arterial system. The venous system has low pressure conditions that result in slow flow rates. Additionally, there is no observable pulsatile blood return in the vascular system, as there is in arteries. This increases the difficulty of observing blood flow, as it is very difficult to visually distinguish slow blood return from fast pulsatile blood return. To compensate for this, the continuous flashback chamber can have a small cross-sectional area so that blood flow can still be observed. In some aspects, the continuous flashback chamber can be spiral, helical, or have other significantly curved shapes to compensate for the small amount of blood flow within the flashback chamber.

[0065] In another embodiment, the continuous flashback chamber may have multiple vertical cavities disposed within the chamber. For example, each cavity may be spaced approximately 2 mm apart. When blood reaches a vertical cavity, it seeps upward to fill the empty space, which is easily observable by the physician. Thus, the physician can observe the blood seeping upward into the next vertical cavity in the lumen. In another embodiment, several separate pieces of gauze or paper-like material may be placed within the vertical cavities to rapidly wick blood along the length of the flashback chamber, further improving seepage capacity.

[0066] Referring again to FIG. 4C, the needle 30 has an elongated needle body 36, typically ranging in gauge from 16 to 24. The needle body 36 is attached at its proximal end 36b to a needle hub 32, which has a beveled distal tip 36a. The needle hub 32 has a proximal end 32b and a distal end 32a. The distal end 32a of the needle hub 32 has a male Luer connector, e.g., a male Luer slip tip 38, shaped and dimensioned to allow a fluid-tight but releasable connection to a corresponding female Luer connector 28 at the proximal end 20b of the catheter hub 22. The proximal end 32b of the needle hub body 32 is sized and shaped to receive a portion of the distal end 42a of the housing body 42.

[0067] The needle body 36 has a needle bore 36c of uniform cross-section for receiving the guidewire 59 with appropriate clearance, and the beveled distal tip 36a of the needle body 36 is directed upward. A flashback blood port 37 is provided on the uppermost surface of the needle body 36. In some cases, multiple blood ports 37 may be provided along the uppermost surface of the needle body 36. For example, the ports 37 may be spaced apart from one another along the length of the needle body 36. The blood ports 37 provide openings for the inflow of blood into the rapid flashback chamber 24. More specifically, the port 37 of the needle body 36 is spaced apart proximally from the beveled distal tip 36a, thereby providing an intermediate section of the elongated needle body 36 that is configured to cooperate with the elongated catheter body 26 to define the rapid flashback chamber 24 between the outer wall of the needle body 36 and the inner wall of the catheter body 26.

[0068] During catheter insertion, the guidewire actuator 52 is used to move the guidewire 59 within the guidewire track 43 of the housing body 42 by stroking it across the length of the guidewire track 43. As shown in FIG. 5B , this distal movement of the actuator 52 along the needle body 42 toward the needle 30 results in the rounded or spherical distal tip 59 a of the guidewire 59 protruding beyond the distal tip 36 a of the needle assembly 30 and into the blood vessel, thereby enabling the guidewire 59 to guide the catheter to a desired placement location within the vessel. The guidewire actuator 52 has upstanding actuation handles or wings 53 that project away from the housing body 42 and are easily accessible to the user. The actuator's cylindrical collar 54 is slidable along the outer wall 45 of the housing body 42. A sliding member 55 projects inwardly from the collar 54.

[0069] As mentioned above, sliding member 55 has a spherical head 56 and a neck 57 that slidably fit within guidewire track 43 and slot 47, respectively. Thus, head 56 and neck 57 of actuator 52 serve to prevent rotation of the actuator about housing body 42. Additionally, spherical head 56 is attached to gold end 59a of guidewire 59 for advancing and retracting the guidewire in response to movement of actuator 52 between its extreme positions.

[0070] The actuator 52 may further include indicia 58 coupled to the collar 54 and configured to mate with indicia 49 located along the length of the housing body 42 to indicate the distance the guidewire 59 has moved relative to the housing body 42 into the blood vessel during the insertion procedure. As shown in FIG. 9 , the indicia 58 and indicia 49 may be shaped to correspond to one another. For example, the indicia 58 and indicia 49 may have a chevron shape. The indicia 49 may further include alphanumeric indicia 49a spaced apart from one another to indicate specific guidewire advancement distances along the housing body 42. For example, such indicia may be spaced apart every centimeter from a home position 49b (i.e., to account for 3.5 cm of guidewire advancement along a 4 cm catheter).

[0071] Additionally, the home position 49b may include an arrow-shaped marking to help ensure that the guidewire is not being advanced during vascular puncture. The distal tip 59a of the guidewire 59 is positioned at the needle heel when the indicator 58 reaches the first mark (i.e., the "0" mark) during guidewire advancement. Additionally, the housing body 42 may include an annular band 48 having a diameter larger than the outer circumference of the body 42 to act as a bump, and the collar 54 of the actuator 52 is configured to abut and overcome this bump when the guide assembly 50 is retracted proximally from the distally extended position. For example, resistance between the annular band 48 and the collar 54 may make it difficult, but possible, for a user to retract the actuator 52 beyond the annular band 48.

[0072] 5A , at the beginning of the catheter insertion procedure, the actuator 52 is positioned in a fully retracted position. In this fully retracted position, the rounded distal tip 59a of the guidewire 59 may be positioned proximal to the distal tip 36a of the needle assembly 30 and in a clearance position relative to the distal-most needle port 37d so as not to inhibit early visualization of blood flashback into the space between the needle body 36 and the catheter body 26. Upon movement of the actuator 52 from its initial retracted position toward its fully extended position, i.e., toward the distal end 42a of the housing body 42 as shown in FIG. 5B , the indicia 58 will contact and abut the proximal end 32b of the needle hub 32. Such contact limits further movement of the actuator 52 and the corresponding extension of the distal tip 59a of the guidewire 59 beyond the needle distal tip 36a and into the blood vessel.

[0073] The annular space formed between the needle body 36 and the catheter body 26 constitutes the rapid blood flashback chamber 24. In other words, the rapid blood flashback chamber 24 has a circular cross-section and is disposed between the catheter body 26 and the needle body 36 when the catheter assembly 20 is carried on the needle assembly 30 in the over-the-needle position. With particular reference to FIG. 10 , the internal bore 26c of the catheter body 26 forms with the needle body 36 a relatively shallow, longitudinally extending well or recess 26d, with a distal portion 26e of the well 26d disposed distally of the distal-most flashback port 37d and a proximal end of the well disposed proximal of the proximal-most flashback port provided on the uppermost surface of the needle body 36.

[0074] The inner wall of the catheter body 26 and the outer wall of the needle body 36 form a fluid-tight snug fit between the distal portion 26e of the well 26d and the distal end 26a of the catheter body 26. Thus, when blood flows from the blood vessel through the needle bore 36c and through the port 37 into the first flashback chamber 24, no fluid leakage occurs between the distal end of the rapid flashback chamber 24 and the tip 36a of the needle body 36. The catheter hub 22 and the needle hub 32 similarly form a snug fit at the proximal end of the annular rapid flashback chamber 24 to prevent blood leakage. It should be understood that air can escape to the atmosphere through the proximal end of the annular rapid flashback chamber 24 and between the male slip 38 of the needle assembly 30 and the corresponding female Luer connector 28 of the catheter 20 to allow blood flow into the rapid flashback chamber.

[0075] Furthermore, in some cases, the spacing of the distal-most port 37d from the distal needle tip 36a may be such that only a relatively short flow path for blood flow exists from the beveled distal tip 36a of the needle body 36 through the needle bore 36c and into the distal-most flushback port 37d. Furthermore, as shown in FIG. 10, when the guidewire 59 is in the retracted position, its bulbous distal tip 59a may be positioned in a non-obstructing or gaping position relative to the distal-most or first blood flushback port 37d encountered by the initial blood flow into the needle bore 36c. Specifically, the distal tip 59a of the guidewire 59 is shown positioned substantially midway between the distal and proximal ends of the first flushback port 37d, thereby providing an unobstructed flow path to the first flushback port 37d, and thus the guidewire does not obstruct the flow of blood into the first flushback chamber 24. In some aspects, the rounded distal tip 59a can divert blood flow into the port 37d. It should be understood that other non-obstructive positions can be defined for the guidewire 59 relative to the first flushback port 37d.

[0076] Visualization of the blood flush occurs throughout the length of the first flashback chamber 24 due to at least one flashback port 37d in the needle body 36. Furthermore, the diameter of the guidewire 59 may be selected relative to the diameter of the needle bore 36c to provide an annular blood flow path 36d between the guidewire and the needle bore, which communicates with the first flashback chamber 24 through the spaced-apart ports 37. Thus, when the guidewire 59 is in the retracted position as shown in FIG. 10, two flow paths are established for the flashback blood. Specifically, a first flow path is established through the multiple flashback ports 37 into the first flashback chamber 24, and a second flow path is established along the longitudinal extent of the guidewire 59 from its distal tip 59a to the second flashback chamber defined by the internal flow path of the needle hub 32 and the lumen 44 of the housing body 42 via the annular blood flow path 36d.

[0077] Thus, blood flushing is possible because the outer diameter of the guidewire is small enough to allow sufficient flashback between the outer diameter of the guidewire and the inner diameter of the needle. In other embodiments, blood flushing can be possible due to other design features, such as cut grooves and / or slots formed on the inner surface of the needle that allow an increased volume of blood to flow between the inner diameter of the needle and the outer diameter of the guidewire. Similarly, cut grooves and / or slots can be formed on the outer diameter of the guidewire to allow an increased volume of blood to flow through the space between the inner diameter of the needle and the outer diameter of the guidewire. Furthermore, the cross-sectional area of the guidewire can be varied in different patterns to increase the volume when blood is passing through it. Such varying patterns can be configured to maintain the desired stiffness required for wire advancement of the guidewire along the needle. For example, when the wire is compressed flat, it has higher stiffness in the vertical direction.

[0078] 11 , the needle hub body 32 includes an internal flow passage having a narrowed portion 33 that communicates at its distal end with the needle bore 36c and at its proximal end with a countersunk portion 34 of the internal flow passage. The countersunk portion 34 communicates with a lumen 44 of the housing 42, which has a distal end 42a disposed within an internal cavity 35 formed at the proximal end 32b of the needle hub 32. The internal flow passage of the needle hub 32 cooperates with the longitudinal lumen 44 of the housing body 42 to define a continuous blood flashback chamber. More specifically, blood flow from the needle bore 36c through the narrowed portion 33 and countersunk portion 34 of the internal flow passage is diverted into the distal end 42a of the longitudinal lumen 44 of the housing body 42 via an angled surface 62 of a flow diverter 60. The flow diverter through-hole 64 is configured to allow longitudinal movement of the guidewire 59 without blocking or obstructing the blood flow path into the lumen 44, thus providing a visible, continuous flow of blood during the insertion procedure.

[0079] Thus, when the hub 32 of the needle assembly 30 is attached to the distal end of the housing body 42 and secured thereto, for example by a suitable adhesive, a continuous flow path for flashback blood is established from the beveled tip 36a of the needle body 36, through the internal flow path of the needle hub 32, via the beveled surface 62 of the flow diverter 60, and into the housing lumen 44. The needle hub 32 may further include a gripping member 39 between the distal and proximal ends 32a, 32b of the needle hub. The gripping member 39 is configured to assist a user in gripping the needle assembly during a catheter insertion procedure. The gripping member 39 may include radially extending ribs that are circumferentially spaced apart at their outermost edges to assist a user in gripping the needle hub.

[0080] As mentioned above, both the needle hub 32 and the housing body 42 may be transparent or translucent to provide visualization of the continuous blood flash within the second blood flashback chamber. For example, the needle hub 32 may be formed from a moldable plastic material. The housing body 42 may be made from a transparent or translucent, semi-rigid plastic material with sufficient elasticity while providing some flexibility so that it maintains its generally tubular configuration during use. The needle body 36 may be formed from a suitable metal, such as stainless steel. It may be a spring wire made from a metal, such as stainless steel or nitinol, to provide visualization of the flashback blood into the first flashback chamber 24. The elongated catheter body 26 may similarly be transparent or translucent to provide visualization of the blood flash within the first flashback chamber 24. For example, the catheter body 26 may be manufactured from a single-lumen catheter blank of transparent or translucent polyurethane. In some embodiments, the catheter insertion device may further include a protective cover configured to fit over the catheter body 26 when the catheter 20 is placed over the needle body 36 of the needle assembly 30 .

[0081] Thus, during a catheter insertion procedure, the user first punctures a blood vessel with the needle tip 36a of the catheter insertion instrument 10 with the guide assembly 50 in its retracted position by using a continuous and controlled forward motion to avoid penetrating the vessel wall. The user will know if successful introduction of the needle tip 36a into the blood vessel has occurred when the immediate appearance of a flash of blood is visible in the first or rapid flashback chamber 24, followed by visualization of a blood flash in the second or continuous flashback chamber.

[0082] Once the user confirms the desired position of the needle tip 36a within the vessel, they stabilize the needle assembly 30 and carefully advance the actuator 52 distally of the guidewire 59 by moving it over a relatively short forward stroke. As the guidewire 59 is advanced distally, the second flashback chamber receives a continuous flow of blood, thereby letting the user know that the desired needle placement is being maintained. If the user retracts the guidewire 59 while the needle tip is still located within the vessel due to resistance encountered during guidewire advancement, the second flashback chamber will nevertheless still receive a continuous flow of blood as long as needle tip placement is maintained within the vessel.

[0083] Once the guidewire 59 has been positioned within the blood vessel a predetermined length by the stroke performed by the actuator 52, the user grasps the catheter body 26 and advances the catheter 20 distally relative to the needle assembly 30. The distal end 20a of the catheter 20 is configured to track the position of the guidewire 59 within the blood vessel. Thereafter, while holding the catheter 20 in place within the blood vessel, the user can withdraw the needle assembly 30 from the blood vessel. Ancillary devices, such as an injection cap, a valve, or medical tubing, can then be attached to the luer connector 28 of the catheter hub 22.

[0084] In addition to the sharpened tip, the distal needle tip 36a may further include one or more echogenic features, as shown in Figures 12A and 12B. Such echogenic features may include, for example, a depression 36e, as shown in Figure 12A. Such depression 36e may enhance the echogenicity of the needle tip 36a when viewed under ultrasound. Similarly, such echogenic features may further include, for example, a through-hole 36f, as shown in Figure 12B. Such through-hole 36f may also enhance the echogenicity of the needle tip 36a when viewed under ultrasound. Visible echogenic features allow a physician to better visualize the placement of the needle body 36 using ultrasound imaging equipment.

[0085] As mentioned above, the lumen 44 and guidewire track 43 open through the proximal end 42b of the housing body 42. This open proximal end 42b of the lumen 44 of the housing body 42 is sealed by a porous blood containment and vent plug 70, which is configured to allow purging of air from within the lumen while also preventing blood flow from escaping the proximal end 42b of the lumen 44. Additionally, the plug 70 is configured not to seal the proximal end of the guidewire track 43.

[0086] 13A and 13B, an embodiment of plug 70 includes a plug body 72 configured to fit within lumen 44 at the proximal end 42b of the housing body 42. Plug 70 further includes an enlarged plug head configured to abut the proximal end 42b of the housing body when plug body 72 is inserted into lumen 44. A longitudinal channel 75 extends therethrough throughout the length of plug 70 and is configured to prevent plug occlusion of guidewire track 43 when plug body 72 is inserted into lumen 44. Accordingly, both plug body 72 and plug head 74 may have a substantially crescent-shaped cross-section corresponding to the substantially crescent-shaped cross-section of lumen 44. In another embodiment, the plug 70 may further include at least one longitudinal cylindrical vent extending through the length of the plug, which may allow for purging of air from within the lumen while also acting to prevent blood flow from leaking out the proximal end 42b of the lumen 44.

[0087] FIG. 13C shows another embodiment of a plug 70a that includes at least one ventilation through-hole 76 configured to communicate directly with the housing body lumen. In another embodiment, the plug may have a crescent-shaped hole configured to mate with the crescent shape of the housing lumen and an extruded or raised surface configured to mate with the guidewire track. Another embodiment may include a bloodless plug integrally formed with the housing body. Yet another embodiment may include a bloodless plug having a small pre-slit silicone sheet, with the guidewire operable to be pushed into the slit, which can then seal around the circumference of the guidewire. In yet another embodiment, a duckbill-shaped silicone seal may serve to allow the guidewire to be pushed through it, but when pressure from the vasculature is applied externally to the seal, the seal closes itself over the guidewire, thus preventing blood leakage.

[0088] Another embodiment may include a second chamber configured to contain blood droplets that may escape through the small gap between the plug hole and the outer circumference of the guidewire. This blood-receiving region may be an empty space that allows blood collection. Alternatively, the blood-receiving region may contain gauze or other absorbent material that prevents escaped blood from dripping out of the chamber. Another embodiment may include a wire advancer that can mate with a bloodless plug, such that, upon sufficient advancement of the wire advancer, the bloodless plug hole is further sealed to prevent blood seepage.

[0089] 14 illustrates a catheter insertion device 100 configured to provide continuous blood flash visibility during catheter insertion in accordance with another embodiment of the present invention. The catheter insertion device 100 is substantially similar to the catheter insertion device 10 described above, except that the catheter insertion device 100 includes a needle assembly 130 capable of providing sharps protection for the distal needle tip 136a. Specifically, the needle assembly 130 includes a needle hub 132 configured to removably receive a safety guard 210 capable of providing sharps protection for the distal needle tip 136a.

[0090] 15A shows a safety guard 210 removably mounted within the distal end 132a of the needle hub 132. The safety guard 210 includes a generally hollow safety cartridge 212 having a proximal opening 214 at its proximal end. The safety guard 210 further includes a safety cap 216 having a throughbore 218 configured to slidably receive the needle body 136. The safety cap 216 is configured to be releasably secured to the catheter 20. Specifically, the safety cap 216 includes a tip 217 at its distal end that includes a pair of clips configured to expand when a needle is passed through the tip 217. When the clips are expanded, they engage corresponding inner rings mounted on the interior surface of the catheter, preventing the safety assembly from being easily removed from the catheter.

[0091] The safety cartridge 212 and safety cap 216 are preferably molded from a plastic material. The safety cap 216 may be secured to the safety cartridge 212 by tab members extending from the cap and configured to securely snap into respective detents formed on the cartridge. In other embodiments, the safety cap may be secured to the safety cartridge with glue, solvent, or some other adhesive. Once secured together, the cartridge 212 and the ky-up 216 cooperate to define an interior cavity 220.

[0092] A generally U-shaped pivotable latch 222 is disposed within the interior cavity 220. The pivotable latch 222 has a proximal wall 224 defining a beveled proximal opening 226 and a distal wall 228 with a distal opening 230. The proximal wall 224 and the distal wall 228 are disposed on opposite sides of a latch body 232. The pivotable latch 222 can be made of stainless steel or spring steel, among others. In other embodiments, the pivotable latch can be molded as a single piece from a plastic material. The proximal opening 226 and the distal opening 230 of the pivotable latch 222 are sized to allow the needle body 136 to pass through the openings 226, 230. In some aspects, the proximal and distal openings 226, 230 can be circular, coaxial, and only slightly larger than the diameter of the needle body 136 to allow the needle body 136 to move through the openings 226, 230.

[0093] The distal wall 228 of the latch 222 further includes a slot 234 in communication with the distal opening 230. The slot 234 has a width that is smaller than the diameter of the distal opening 230 and the diameter of the needle body 136. The width of the slot 234 is large enough to allow the passage of the guidewire 59. The slot 234 preferably extends from the periphery of the distal opening 230 to the upper edge of the distal wall 228. In use, the slot 234 allows the needle to pivot downward while preventing the needle from being pushed through the slot. Additionally, the inner cavity of the safety cartridge may include a nub that securely secures the safety clip to the needle when the cartridge is ejected from the needle. Additionally, a binding action at the proximal end of the inner periphery of the safety clip may occur on the needle to lock the needle tip in place within the safety cartridge.

[0094] FIG. 15A shows the pivotable latch 222 in a first, or unlocked, position. A biasing member 238, e.g., a leaf spring, is provided within the interior cavity 220 and is capable of biasing the pivotable latch toward a second, or locked, position shown in FIG. 15B, which is described further below. The biasing member 238 is bent from its normally straight position toward a curved position such that the curved spring is compressed when loaded into the cartridge. As a result, the spring is able to relax to push the latch 222 downward when the needle bevel passes through the distal clip hole 230 and enters the slot.

[0095] A first end portion of the spring 238 contacts the top wall of the interior cavity 220. A second end portion of the spring 238 contacts the body 232 of the latch 222. Specifically, the second end portion of the spring 238 is welded to the body of the latch. The biasing member 238 can have a substantially rectangular central portion with an elongated opening 246 that generally aligns with the proximal opening 226 of the latch so that the needle body 136 can pass through both openings 226, 246. The opening 246 of the latch can have a diameter that is only slightly larger than the diameter of the needle body 136. The biasing member 238 can be made of a resilient material that can bite into the needle body 136 when the latch is rotated to the locked position. In other words, the latch locks into the needle when the spring rotates the clip. In some aspects, the biasing member 238 can be made of stainless spring steel.

[0096] Referring back to the unlocked position shown in FIG. 15A, in use, the needle body 136 is inserted into the safety cartridge 212 through its proximal opening 214, passing through the interior cavity 220, the proximal and distal openings 226, 230 of the pivotable latch 222, and through the through-hole 218 of the safety cap 216, such that the needle tip 136a is positioned outside the safety guard 210 during catheter insertion.

[0097] During the insertion procedure, as the catheter is advanced forward, it pulls the safety guard, along with the catheter, toward the needle tip. For example, referring to the locked position shown in FIG. 15B , when the safety guard 210 is removed from the needle hub 132 and moved toward the distal needle tip 136a, the needle body 136 is correspondingly retracted into the safety cartridge 212 and further withdrawn from the distal opening 230 of the pivotable latch 222, causing the biasing member 238 to move toward its unbent or relaxed position, thereby tilting the pivotable latch 222 about the needle body 136. Thus, initially, the safety guard is advanced forward due to catheter advancement, and the needle remains stationary. Then, after the catheter is advanced fully or at least partially forward, the catheter becomes stationary and the needle is withdrawn backward from the patient.

[0098] Because the pivotable latch 222 is made of a sufficiently rigid metallic material, such as stainless steel, and the diameter of the proximal opening of the pivotable latch 222 is only slightly larger than the diameter of the needle body 136, the pivotable latch 222 bites into the needle body 136, coupling or locking it, thereby preventing further forward or rearward movement of the needle body when the pivot member 222 is tilted about the needle body 136 after the needle tip 136a is retracted from the distal opening 230 of the latch 222 into the internal cavity 220. The biasing member 238 thus provides a means for tilting the pivotable latch about the needle when the needle tip is located within the cavity. The tilting means further engages the needle body to prevent removal of the needle body from the safety guard. For example, the needle tip is operable to drop into a slot distal to the latch to prevent forward movement of the needle, thereby locking the needle in place. The coupling of the latch to the needle body prevents rearward movement. Additionally, the internal humps of the safety cartridge further facilitate rotation of the clip and enhance the clip's engagement with the needle to further inhibit rearward movement.

[0099] As a result of the additional force applied to the needle when in the locked position, an even greater binding force is applied to the needle body 136. For example, by attempting to remove the needle body 136 from the safety guard 210 when in the locked position, the surface of the pivotable latch 222 contacts the surface of the interior cavity 220. This contact serves as a stop to reinforce the tilt of the pivotable latch 222, and causes the pivotable latch 222 to further bite into the needle body 136, thereby binding or locking the needle tip within the safety guard and preventing further movement thereof. Thus, once the pivotable latch 222 is tilted about the needle body 136, further backward movement of the needle is prevented.

[0100] Similarly, further forward movement of the needle is also prevented once the pivotable latch 222 is tilted about the needle body 136. A biasing member 238 maintains the pivotable latch 222 in its tilted position relative to the needle body 136. As a result, once the latch is tilted about the needle body 136, no relative movement is possible between the needle tip 136a and the pivotable latch 222. Thus, once the distal wall 228 of the pivotable latch 222 is pressed against the safety cap 216, neither the pivotable latch 222 nor the needle 202 can move further. Furthermore, even if the binding force of the pivotable latch 222 against the needle body 136 could be overcome, forward movement of the needle would be prevented by the latch slot 234, which is slightly smaller than the outer diameter of the needle body.

[0101] 15B, the biasing member 238 is expanded toward its unbent position. Because the slot 234 has a width smaller than the diameter of the needle body 136, needle movement is prevented and, therefore, the needle tip 136a cannot be pushed so that it extends outside the safety guard 210. However, the guidewire 59 disposed within the bore of the needle body 136 can pass through the slot 234 because the slot has a width greater than the diameter of the guidewire. Thus, the biasing member 238 positions the slot 234 so that the guidewire can exit the safety cap 216 even when the pivotable latch 222 is tilted about the needle body. Furthermore, advancement of the wire does not prevent tilting of the latch.

[0102] Therefore, in view of the above, the catheter insertion device of the present invention is operable to provide the following features: 1) visibility of blood flash through the catheter; 2) visibility of blood flash within the wire lumen prior to guidewire advancement (including the ability to re-check the flash if stopped); 3) visibility of blood flash within the wire lumen during wire advancement (including the ability to re-check the flash if stopped); 4) visibility of blood flash within the wire lumen after wire advancement (including the ability to re-check the flash if stopped); 5) the wire tip being located inside and near the needle tip at the start of the catheter insertion procedure; and 6) the wire lumen design prevents excessive blood exposure and separates blood within the wire lumen from the wire within the wire lumen.

[0103] While the catheter insertion device has been described with respect to what can be considered particular aspects, the present invention is not limited to the disclosed aspects. Additional modifications and improvements to the catheter insertion device will be apparent to those skilled in the art. Moreover, the many features and advantages of the present invention are apparent from the detailed description, and it is, thus, intended by the appended claims to cover all such features and advantages of the present invention, which are within the spirit and scope of the present invention. Moreover, it is not desired to limit the invention to the exact construction and operation shown and described; therefore, all suitable modifications and equivalents falling within the scope of the present invention may be resorted to. Accordingly, the present disclosure is to be interpreted as illustrative, and not limiting. Therefore, it is intended that the present disclosure cover various modifications and similar arrangements included within the spirit and scope of the present invention as defined by the claims, and the spirit and scope of the claims should be accorded the broadest interpretation so as to encompass all such modifications and similar structures.

Claims

1. A catheter insertion device, comprising: a needle including a needle body coupled to a needle hub, the needle body having a longitudinal bore and a distal needle tip configured to puncture a wall of a blood vessel, the needle hub having an internal flow passage in fluid communication with the longitudinal bore of the needle body; a catheter including a catheter body coupled to a catheter hub, the catheter body configured to slide over the distal needle tip of the needle body, the catheter and the needle cooperating to define a first blood flashback chamber configured to receive an initial flow of blood upon insertion of the distal needle tip of the needle into the blood vessel; a housing including a housing body coupled to the needle hub, the housing body having a lumen defining a second blood flashback chamber in fluid communication with the internal flow path of the needle hub; a guide assembly slidably mounted to the housing body, the guide assembly including a guide wire operable to move between a retracted position and an extended position, the second blood flashback chamber configured to receive a continuous flow of blood during movement of the guide wire from the retracted position to the extended position; a safety guard removably received within the distal end of the needle hub and having an internal cavity, the safety guard including a latch and a spring disposed in the internal cavity, the latch operable to pivot from an unlocked position to a locked position, and the spring operable to bias the latch to the locked position to provide sharps protection for the distal needle tip of the needle body.

2. 2. The catheter insertion apparatus of claim 1, wherein the latch comprises a proximal wall and a distal wall, the proximal wall comprising a proximal opening configured to slidably receive the needle body, and the distal wall comprising a distal opening configured to slidably receive the needle body, and the spring biases the latch to the locked position when the distal needle tip of the needle is withdrawn from the distal opening in the distal wall of the latch.

3. 3. The catheter insertion device of claim 2, wherein the proximal and distal openings are axially aligned when the latch is in the unlocked position, and the proximal and distal openings are axially misaligned when the latch is in the locked position.

4. 4. The catheter insertion device of claim 2 or 3, wherein the proximal opening is beveled.

5. The distal wall of the latch further includes a slot in communication with the distal opening. A catheter insertion device according to any one of claims 2 to 4.

6. The catheter insertion device of claim 5 , wherein the width of the slot is less than the diameter of the distal opening of the latch and the diameter of the needle body.

7. 7. The catheter insertion device of claim 5, wherein the width of the slot is greater than the diameter of the guidewire.

8. 8. The catheter insertion device of claim 5, wherein the slot extends from the distal opening to an upper edge of the distal wall of the latch.

9. 9. The catheter insertion device of claim 5, wherein the slot is configured to slidably receive the guidewire when the latch is in the locked position.

10. 10. The catheter insertion device of claim 1, wherein a first end portion of the spring contacts a safety cartridge of the safety guard and a second end portion of the spring contacts the latch to bias the latch into the locked position.

Images