Catheter placement device including extendable needle safety feature

Abstract

An insertion device for inserting a catheter into a patient is disclosed. The insertion device combines needle insertion, guidewire advancement, catheter insertion, and needle protection into a single device. In one embodiment, the insertion device includes a housing and a hollow needle extending distally from the housing. At least a portion of a catheter is pre-disposed on the needle such that the catheter is generally disposed outside of the housing. The insertion device also includes a guidewire and an advancement assembly configured to selectively advance a distal end of the guidewire out of a distal opening of the needle in preparation for distal advancement of the catheter. The advancement assembly is also configured to enable distal advancement of the catheter prior to sheathing of the needle after use. The insertion device is configured to be grasped and used by a user with a single hand during advancement of the guidewire and catheter.

Description

[0001] Case information

[0002] This application is a divisional application of patent application No. 202110775673.4, filed on May 13, 2016, entitled "Catheter Placement Device Including an Extendable Needle Safety Component", which in turn is a divisional application of patent application No. 201680037398.3, filed on May 13, 2016, entitled "Catheter Placement Device Including an Extendable Needle Safety Component".

[0003] Cross-referencing of related patent applications

[0004] This patent application claims the benefit of U.S. Provisional Patent Application 62 / 162,548, filed May 15, 2015, entitled “Catheter Placement Device Including an End-Mounted Advancement Component,” the entire contents of which are incorporated herein by reference. Summary of the Invention

[0005] In summary, embodiments of the present invention relate to an insertion device for inserting a catheter or other tubular medical device into a patient. This insertion device integrates needle insertion, guidewire advancement, catheter insertion, and needle protection into a single device. In one embodiment, the insertion device includes a housing and a hollow needle extending distally from the housing. At least a portion of the catheter is pre-positioned on the needle such that the catheter is substantially outside the housing. The insertion device also includes a guidewire and an advancement assembly configured to selectively expel the distal end of the guidewire from a distal opening in the needle to prepare for distal advancement of the catheter. The advancement assembly is further configured to selectively advance the catheter distally. The insertion device is configured to be grasped and used by a user with one hand during the advancement of the guidewire and catheter.

[0006] In another embodiment, a continuous flash indicator is disclosed to help confirm that the needle of the catheter insertion device has been inserted into and remains in a vein or other blood-delivering vessel. In yet another embodiment, a needle safety component for use with the catheter insertion device is disclosed.

[0007] These and other features of the embodiments of the present invention will become more apparent from the following description and the appended claims, or may be learned by practicing the embodiments of the present invention as shown below. Attached Figure Description

[0008] A more specific description of the present disclosure will be given with reference to specific embodiments illustrated in the accompanying drawings. It should be understood that these drawings merely illustrate typical embodiments of the invention and should not be construed as limiting its scope. Exemplary embodiments of the invention will be described and explained in more detail using the accompanying drawings, in which:

[0009] Figures 1A to 1J Various views of a catheter insertion tool according to one embodiment are shown;

[0010] Figures 2A to 2C It shows Figures 1A to 1J Various views of the components of the catheter insertion tool;

[0011] Figures 3A to 3C It shows Figures 1A to 1J The various stages of using catheter insertion tools;

[0012] Figure 4 This is a cross-sectional side view of a blood flash indicator according to one embodiment;

[0013] Figure 5 This is a perspective view of a blood flash indicator according to one implementation scheme;

[0014] Figure 6 This is a top view of a blood flash indicator according to one implementation scheme;

[0015] Figure 7 This is a top view of a blood flash indicator according to one implementation scheme;

[0016] Figures 8A to 8H These are various views of a catheter insertion tool according to one implementation scheme;

[0017] Figures 9A to 9G These are various views of the needle safety component according to an implementation scheme;

[0018] Figure 10 It is a cross-sectional view of the needle and guidewire according to one implementation scheme;

[0019] Figure 11 It is a cross-sectional view of the needle and guidewire according to one implementation scheme;

[0020] Figure 12 It is a cross-sectional view of the needle and guidewire according to one implementation scheme;

[0021] Figure 13 This is a partial cross-sectional side view of the needle and guidewire according to one embodiment;

[0022] Figure 14 This is a partial cross-sectional side view of the needle and guidewire according to one embodiment;

[0023] Figure 15 This is a partial cross-sectional side view of the needle and guidewire according to one embodiment;

[0024] Figure 16 This is a partial cross-sectional side view of the needle and guidewire according to one embodiment;

[0025] Figure 17 This is a side view of a guidewire according to one implementation scheme;

[0026] Figure 18 This is a perspective view of the propulsion component of a conduit insertion tool according to one embodiment;

[0027] Figure 19 This is a top view of a blood flash indicator according to one implementation scheme;

[0028] Figure 20 This is a top view of a blood flash indicator according to one implementation scheme;

[0029] Figure 21 This is a top view of a blood flash indicator according to one implementation scheme;

[0030] Figure 22 This is a top view of a blood flash indicator according to one implementation scheme;

[0031] Figure 23 This is a top view of a blood flash indicator according to one implementation scheme;

[0032] Figure 24 This is a top view of a blood flash indicator according to one implementation scheme;

[0033] Figure 25 This is a top view of a blood flash indicator according to one implementation scheme;

[0034] Figures 26A to 26D These are various views of a catheter insertion tool according to one implementation scheme;

[0035] Figures 27A to 27E These are various views of a catheter insertion tool according to one implementation scheme;

[0036] Figure 28 This is a perspective view of a blood flash indicator according to one implementation scheme;

[0037] Figure 29 It is a perspective view of a catheter insertion tool according to one embodiment; and

[0038] Figure 30A and Figure 30B Various views of a blood flash indicator according to one embodiment are shown. Detailed Implementation

[0039] Referring now to the accompanying drawings, similar structures will have similar reference numerals. It should be understood that the drawings are illustrations and diagrams of exemplary embodiments of the invention, and not limitations thereof, nor are they necessarily drawn to scale.

[0040] For clarity, it should be understood that the term "proximal" refers to the direction relatively closer to the clinician using the device described herein, while the term "distal" refers to the direction relatively farther from the clinician. For example, the end of a catheter placed inside the patient is considered the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. Furthermore, the terms "comprising" and "having" as used herein (including the claims) should have the same meaning as the term "including".

[0041] Generally, embodiments of the present invention relate to a tool for assisting in the placement of catheters or other tubular medical devices into a patient. For example, catheters of various lengths are typically placed in a patient to establish access to the patient's blood vessels and to enable the infusion of medications or aspiration of fluids. The catheter insertion tool described herein facilitates such catheter placement. It should be noted that while the following discussion focuses on the placement of specific types and relatively short lengths of catheters, many types, sizes, and lengths of catheters can be inserted via this device, including peripheral venous intermediate or extended indwelling catheters, PICC catheters, central venous catheters, etc. In one embodiment, catheters with lengths between about 1 inch and about 1.9 inches can be placed, but many other lengths are also possible.

[0042] Figures 1A to 1J Various details of a catheter insertion tool (“insertion tool” or “insertion device”), generally designated 10, according to one embodiment are shown. As shown, the insertion tool 10 includes a housing 12, which itself may include a top front housing portion 12A, a top rear housing portion 12B, and a bottom housing portion 12C that engage with each other via protrusions and slots 78 or other suitable attachment modes. The housing 12 also includes an open distal end 12D and a flat bottom 12E that allows the insertion device 10 to lie flat on a surface without tilting. In another embodiment, the housing is integrally formed. In another embodiment, only the top and bottom housing portions are used. In this embodiment, the housing is made of a thermoplastic such as polycarbonate and is translucent, but other configurations are also contemplated. In this embodiment, ribs 38 extend along the longitudinal length of the bottom housing portion 12C. Figure 1B and Figure 1G As shown, the housing 12 defines a gripping surface 74 on either side of the housing so that the user can grip the insertion device 10.

[0043] The housing 12 includes a needle hub 14 that supports the hollow needle 16 (which, in one embodiment, forms part of the needle assembly). In this embodiment, as in... Figure 1I As clearly shown, the needle hub 14 and housing 12 are integrally formed within a cavity 70 defined by the housing, although the needle hub may be constructed in other ways. The needle hub 14 includes a recess 14A for receiving a portion of the needle 16 and a quantity of adhesive (e.g., a liquid or UV-curable adhesive) to secure the needle within the hub. The needle 16 extends distally from the hub 14 to extend through an open distal end 12D of the housing 12 and terminate at a distal end 16B. A notch 18 is defined to penetrate the wall of the needle 16, near the distal end of the needle. During catheter insertion procedures, the notch 18 allows blood to flow back out of the lumen defined by the hollow needle once the hollow needle 16 has entered the patient's blood vessel. Therefore, the blood flowing out of the notch 18 can be observed by the clinician to confirm proper needle placement in the blood vessel, as will be further explained below.

[0044] The conduit 42 is removably disposed on the portion of the needle 16 located outside the housing 12, such that the needle occupies the lumen of the conduit defined by the conduit body 44. The conduit body 44 extends distally from the hub 46 of the conduit 42, which is initially disposed near the open distal end 12D of the housing 12, as... Figures 1A to 1C As shown.

[0045] The insertion tool 10 also includes a guidewire advancement assembly 20 for advancing the guidewire 22 through the needle 16 and into the patient's blood vessel once needle entry is achieved. Guidewire 22 ( Figure 1I The guidewire is pre-positioned within the lumen of the needle 16. The guidewire advancement assembly 20 includes a guidewire rod 24 that selectively advances the guidewire 22 distally during use of the insertion tool 10, such that the distal portion of the guidewire extends beyond the distal end 16B of the needle 16. A finger pad 28 of the guidewire rod 24 is slidably disposed on the housing 12 via a slot 32, allowing the user's thumb and / or finger to selectively advance the guidewire 22 distally past the distal end 16B of the needle 16. Alternatively, other engagement schemes that convert user input into guidewire movement may also be employed. In this embodiment, the guidewire 22 includes a guidewire support tube 19 (… Figure 1I , Figure 1J This provides additional stiffness to the guide wire and facilitates its distal propulsion as described above.

[0046] Together Figure 1H Together, for reference Figures 2A to 2C Described Figures 1A to 1JFurther details of the insertion tool 10 are shown. Further details of the guidewire rod 24 are shown, including a rod protrusion 26 located at the proximal end of the guidewire rod, which is used as described below during distal advancement of the guidewire 22. An angled portion 24A of the guidewire rod 24 is located distal to the rod protrusion 26. A push protrusion 30 is defined below the finger pad 28 and is used to partially advance the conduit 42 distally during distal advancement of the guidewire rod 24, as will be described below.

[0047] In this embodiment, the proximal end of the guidewire 22 is attached to an anchor point 36 inside the housing 12 (or to another fixed portion of the insertion tool 10), and is arranged in a generally U-shaped configuration around the proximal end portion of the guidewire rod 24. Figure 1H This causes the distal end of the guidewire to extend distally through the distal end 16B of the needle 16 for each distance unit of movement of the finger pad 28, by two distance units.

[0048] To be more detailed, Figures 2A to 2C A curved guide surface 34 is shown defined on the proximal end of the guidewire 24, allowing the middle portion of the guidewire 22 to self-wrap near the proximal end of the device 10. The guide surface 34 constrains the flexible guidewire 22 into a loop-like, generally U-shaped configuration. The angled portion 24A of the guidewire 24 helps to keep the radius of the U-shaped portion of the guidewire 22 sufficiently large to prevent tangling / undesired bending during guidewire rewinding. The rewound middle portion of the guidewire 22 then extends toward the distal end of the device 10 within the cavity 70 of the housing 12 before entering the lumen of the needle 16 at the proximal end of the needle secured by the needle hub 14. In this embodiment, a strip 34A is positioned on the guide surface 34 to maintain contact between the guidewire 22 and the guide surface. In one embodiment, a rib 38 may include a channel in which a portion of the middle portion of the loop-shaped guidewire 22 may be located to guide the guidewire to the proximal end of the needle 16.

[0049] In this configuration, the free distal end of the guidewire 22 is initially located within the lumen of the needle 16 and is arranged to be selectively advanced by the guidewire advancement assembly 20, such that its free distal end can extend distally from the open distal end of the needle 16. In this embodiment, this selective advancement of the guidewire 22 is achieved via a finger pad 28 included on the distally moving device housing 12. Moving the finger pad 28 distally causes the guidewire rod 24 to slide distally accordingly. As the guidewire rod 24 advances, the guide surface 34 of the guidewire rod 26 pushes the bend of the guidewire 22 distally. It should be noted that the guidewire 22 has sufficient rigidity, partly due to the guidewire support tube 19, to be advanced by the guidewire rod 24 without buckling. Furthermore, the guide surface 34 and the guidewire 22 are configured such that when the finger pad 28 (or other suitable mechanism in other embodiments) slides proximally, the guidewire 22 can retract into the insertion device housing 12.

[0050] This distal sliding movement of the guidewire 24 causes the distal end of the guidewire 22 to extend distally from the open distal end 16B of the needle 16. This is due to the anchoring proximal end at the anchoring point 36 and the curved or loop-shaped U-shaped configuration ( Figure 1H The guidewire 22 is advanced distally at a linear rate approximately twice that of the finger pad 28, resulting in a guidewire extension length approximately twice the travel length of the guidewire advancement slide. This further results in a relatively longer guidewire extension into the vein or other blood vessels of the patient, allowing for more suitable insertion of the catheter 42 into the patient's body. Therefore, the guidewire advancement assembly described herein operates as a "reverse pulley" system for distally advancing the guidewire. It should be noted that, in addition to those shown and described herein, the device 10 may also include other annular configurations of the guidewire. Furthermore, in other embodiments, the guidewire extension and the movement of the advancement assembly may have different ratios.

[0051] It should be noted that the above-described structure for providing the annular guidewire is merely an exemplary structure suitable for performing the desired functions described herein. In practice, other structures can be employed to achieve the principles described in conjunction with this embodiment. Furthermore, although the proximal end of the guidewire is shown and described above as being attached to the catheter insertion device housing, the proximal end of the guidewire may be attached to other structures within / on the device, such as needle hub 14. In one embodiment, the majority of the guidewire's length comprises a nickel-titanium alloy (commonly referred to as nitinol), which has sufficient rigidity and can be configured in a U-shape configuration without retaining positional memory as the guidewire is advanced. It should be noted that other suitable guidewire materials may also be used.

[0052] The insertion tool 10 also includes a catheter advancement assembly 40 for selectively advancing a catheter 42 onto a needle 16 pre-positioned outside the housing 12 in a distal direction. Specifically, the catheter advancement assembly 40 includes an advancement member 48 initially located within the cavity 70 defined by the housing 12 and for selectively advancing the catheter 42 distally during use of the insertion tool 10 to insert the catheter into the patient's body. As shown, the advancement member 48 also functions as a needle safety component, covering the needle 16 after use of the device 10 to prevent injury to the user, as will be further described below.

[0053] Figures 2A to 2C Further details of the advance member 48 of the catheter advance assembly 40 according to this embodiment are shown. As shown, the advance member 48 defines an elongated body configured to span the needle 16 when the advance member 48 is initially disposed within the housing cavity 70. The body of the advance member 48 includes a distal portion 49. A pair of hub engagement protrusions 50 extend distally from the distal end of the distal portion 49, and each engagement protrusion includes a radially extending projection 52. When the advance member 48 is disposed within the housing 12, the needle 16 passes distally between the engagement protrusions 50, as... Figure 1H As shown. The propulsion member 48 is configured such that the needle 16 extends radially outward by a relatively small distance when positioned between the engaging protrusions 50. When positioned on the needle 16, as... Figure 1H As shown, the conduit 42 is secured relative to the distal end 12D of the open housing by the protrusion 52 of the engagement protrusion 50, thereby forming a frictional fit with the inner surface of the conduit hub 46. As will be seen further below, when the needle 16 is no longer arranged between the engagement protrusions 50, the protrusions are pulled radially inward to allow the conduit to separate from the distal end of the advance member 48.

[0054] The distal portion 49 of the propulsion member 48 also includes a propulsion protrusion 54 for assisting manual distal extension of the propulsion protrusion during deployment of the conduit 42, and a plurality of top and bottom ribs 56 extending on the body of the propulsion member to connect the two elongated arms 58, which extend longitudinally from the distal portion toward the proximal side. Figure 1G and Figure 1H The diagram shows the arm 58 spanning the needle 16 when the propulsion member 48 is initially positioned within the cavity 70 of the housing 12. Top and bottom ribs 56 are arranged such that, after the propulsion member 48 has completed its extension from the housing 12, the distal end 16B of the needle 16 is covered to prevent user contact, as discussed further below. Furthermore, the proximal end 56A of the ribs 56 ( Figure 1H It serves as a barrier against a pair of locking wedges 72 formed relative to the housing 12 to prevent the propulsion member 48 from further entering the housing cavity 70 towards the proximal end.

[0055] Each arm 58 includes an auxiliary protrusion 60 located proximal to the distal portion 49 to assist manual extension of the propulsion member 48 in a distal direction, together with the propulsion protrusion 54, by allowing the user's fingers to push the position. Near the proximal end of each propulsion member arm 58, a locking protrusion 62 is included. The locking protrusions 62 are deformable as the propulsion member 48 extends distally during distal advancement of the catheter (described below) to allow them to pass over the locking wedge 72, thereby preventing the propulsion member from re-entering the housing cavity 70. This also ensures that the distal end 16B of the needle 16 remains covered by the rib 56 of the distal portion 49 of the propulsion member. Furthermore, a stop surface 64 is included on the propulsion member arm 58 near each locking protrusion 62 to prevent the propulsion member 48 from completely disengaging from the housing 12 as the propulsion member extends distally from the housing. This is accomplished by engaging each stop surface 64 with a corresponding one of the locking wedges 72, which prevents further distal movement of the propulsion member. Therefore, after fully extending distally, the movement of the propulsion member 48 from either proximal side is locked, allowing the propulsion member to re-enter the housing cavity 70 via the engagement of the locking protrusion 62 and the locking wedge 72, or to move further distally via the engagement of the stop surface 64 and the locking wedge. In addition to these, other modes may be employed after the propulsion member has extended distally to prevent undesirable proximal and distal movement of the propulsion member.

[0056] It should be noted that in one embodiment, the outer diameter of the needle 16 and the catheter body 44 is lubricated with silicone or other suitable lubricant to enhance the sliding of the catheter body relative to the needle and facilitate catheter insertion into the patient.

[0057] Figures 3A to 3C The various stages of placing the catheter 42 into a patient's blood vessel using the insertion device 10 are illustrated. For clarity, the stages are depicted without showing actual insertion into the patient. The insertion device 10 is in... Figure 1E In the configuration shown, the user holding the insertion device 10 first guides the distal portion of the needle 16 through the skin at the appropriate insertion site and into the subcutaneous blood vessel.

[0058] After the confirmation needle enters the blood vessel, the guidewire advancement assembly 20 is actuated, wherein the finger pad 28 (located in a slot 32 defined in the housing) is advanced by the user's finger to advance the guidewire 22 initially positioned within the hollow needle 16 distally. Figure 3A It should be noted that the guidewire 22 is advanced distally by the guidewire rod 24, which is operatively attached to the sliding finger pad 28.

[0059] The distal advancement of guidewire 22 continues until finger pad 28 has slid distally a predetermined distance, resulting in guidewire 22 of a predetermined length extending past the distal end of needle 16, as... Figure 3A As shown.

[0060] At this point, the finger pad 28 slides an additional distance distally, which causes the push protrusion 30 of the guide rod 24 to ( Figure 2B The proximal end 56A of the rib 56 of the push member 48 of the guide tube push assembly 40 is located close to the guide tube push assembly 40. This, in turn, causes the push member 48 to be pushed distally out of the open distal end of the housing 12D a predetermined distance. Since it is removably attached to the distal portion 49 of the push member 48 via the hub engagement protrusion 50, the guide tube 42 is also pushed distally a predetermined distance. When the guide tube pushes the notch above the protrusion 30 into contact with the slot 32 defined in the housing 12, the guide tube 42 is pushed distally. Figure 1I When the finger pad 28 reaches the distal end of the finger pad 28, the propulsion member 48 stops pushing distally and the finger pad 28 stops sliding further distally.

[0061] Once the guidewire 24 has been fully extended distally via the sliding of the finger pad 28, this subsequently extends the guidewire 22 past the distal end 16B of the needle 16 and into the patient's blood vessel, and has advanced the advance member 48 and the connected catheter 42 distally a predetermined distance from the device housing 12. Further distal manual advancement of the advance member 48 is performed by the user's fingers by pushing the advance protrusion 54 and subsequent auxiliary protrusion 60 of the advance member, as... Figure 3B As shown. This causes the catheter body 44 to slide over the distal portion of the needle 16 and guidewire 22 and enter the patient's blood vessel through the insertion site. Therefore, it is understood that in this embodiment, the finger pad 28 serves as a first member for advancing the guidewire 22, while the advancement protrusion 54 serves as a second member for advancing the catheter 42. It is understood that in this embodiment, the finger pad 28 can slide distally to a distal termination point near the proximal start point of the second member, such that movement of the user's finger from the finger pad 28 to the advancement protrusion 54 occurs substantially without finger repositioning.

[0062] The propulsion member 48 and the connecting conduit 42 are manually advanced distally until the propulsion member has been fully extended, as shown. Figure 3BAs shown, the locking protrusion 62 slides on and locks against the locking wedge 72 defined by the housing 12, thereby locking the propulsion member to prevent further distal advancement. In this fully extended state of the propulsion member 48, the distal portion 49 is disposed on the needle 16 and covered by the rib 56. Thus, according to this embodiment, the propulsion member 48 serves as an example of a needle safety component. The engagement of the aforementioned locking protrusion 62 of the propulsion member 48 with the locking wedge 72 and the stop surface 64 prevents further distal or proximal movement of the propulsion member, thereby advantageously ensuring that the distal end 16B of the needle 16 is continuously covered.

[0063] The distal advancement of the advancing member 48 further advances the catheter body 44 distally over the needle 16 and guidewire 22 and into the patient's blood vessel until the catheter hub 46 passes through the skin close to the needle insertion site. Since the needle 16 is no longer positioned between them, the hub engagement protrusion 50 is compressed radially inward, thereby releasing the frictional engagement between the protrusion 52 and the inner surface of the catheter hub. This allows the catheter 42 to disengage from the advancing member 48, as... Figure 3C As shown. The catheter 42, now located in the patient's body, can be prepared for use and wear according to standard procedures. The insertion device 10 can then be discarded.

[0064] In view of the above, it is understood that in this embodiment, the guidewire advancement assembly 20 and the catheter advancement assembly 40 operate in cooperation with each other and thus together constitute the main advancement assembly for placing the catheter 42. It is further understood that in other embodiments, the main advancement assembly may include both or only one of the guidewire advancement assembly and the catheter advancement assembly.

[0065] It should be noted that the device 10 is configured so that the user can perform the gripping of the device and the advancement of the guidewire 22 and catheter 42 using only one hand. In this embodiment, the gripping surface 74 and the finger pad 28 are positioned to facilitate the user's gripping of the device 10, while the finger pad 28 and the guidewire advancement assembly 20 are used to advance the guidewire 22 and catheter 42 a predetermined distance, and then the process is completed by the user manually advancing the advancement member 48 with their fingers. In this embodiment, this can be performed by the user's single thumb, finger, or multiple fingers. Of course, other gripping and advancement configurations may also be used.

[0066] Now for reference Figure 4This illustrates a continuous blood flash indicator 80 for use with device 10 according to one embodiment. The flash indicator 80 is used to indicate the presence of blood in the lumen of needle 16 during use of device 10, thereby ensuring that the needle has been inserted into a vein or other desired blood vessel for delivery. As shown, the flash indicator 80 includes a generally cylindrical, translucent chamber 82 sealed at either end and configured to surround part of needle 16 such that the needle protrudes from either sealed end. In this embodiment, chamber 82 is located precisely distal to needle hub 14 within housing 12, although other locations along the needle are also possible.

[0067] Two notches—a first notch 83 and a second notch 84—are defined in the needle 16 to provide fluid communication between the lumen of the needle and the interior of the chamber 82. In one embodiment, notches 83 and 84 replace notch 18. Figure 1I In another embodiment, notches 83 and 84 are included in addition to notch 18. It is understood that in one embodiment, the blood passage through notch 18 serves as an initial indicator that the distal end 16B of the needle has entered the vein, while the embodiment shown here serves as an additional indicator to confirm that the distal end of the needle remains in the vein after initial entry.

[0068] In this embodiment, the second notch 84 is positioned precisely near the distal end of the guidewire support tube 19, although other notch locations are possible. Also as shown, the guidewire 22 passes through the lumen of the needle 16 to extend through the flash indicator 80. Figure 4 As shown, the distal end of the first notch 83 facing the chamber 82 is located distal to the second notch 84.

[0069] When blood enters a blood vessel through the distal end 16B of the needle 16, it travels proximally along the needle lumen between the inner surface of the needle and the outer surface of the guidewire 22 disposed within the needle lumen. Upon reaching a relatively more distal first notch 83 defined in the needle 16, a portion of the blood passes through the first notch and enters the chamber 82. When the chamber 82 is full of blood, the user can observe the translucent chamber and the blood within it through the translucent housing 12 of the insertion device 10, thereby confirming that blood entry has been achieved. In another embodiment, the housing 12 may be configured such that the chamber 82 can be directly observed, for example, without any insertion structures between the chamber and the user.

[0070] The second notch 84 is used to provide an air outlet in chamber 82 to balance air pressure and allow blood to continue flowing into the chamber through the first notch 83. It should be noted that the distance between the inner surface of the needle 16 and the outer surface of the guidewire support tube 19 allows air, but not blood, to pass through, thereby balancing the air pressure in chamber 82, while the blood flow does not pass through the second notch 84. Thus, the flashing indicator 80 is a continuous indicator, allowing continuous blood flow into chamber 82 when the distal end 16B of the needle is positioned in a blood vessel.

[0071] It should be noted that during the establishment of the blood vessel through needle insertion, the chamber 82 of the flash indicator 80 of this embodiment is positioned directly below the rib 56 of the distal portion 49 of the advance member 48 that has not yet been advanced. This allows the rib 56 to serve as a marker or approximate blood flow meter as blood advances proximally within the chamber 82 of the flash indicator 80; the user observing the blood in the space between the proximally advancing ribs 56 can observe the proximal blood flow during catheter placement. In another embodiment, a spring disposed in the housing 12 (such as a spring for retracting the needle 16) can also serve as a marker for measuring blood flow in the flash indicator. Thus, these and other markers for measuring blood flow in the flash indicator can be considered.

[0072] It should be noted that the catheter insertion device 10 may include more than one flashing indicator. In one embodiment and as described above, for example, the catheter insertion device may include a flashing indicator 80 and another flashing indicator (such as notch 18) that allows blood present in the lumen 17 of the needle 16 to advance proximally along the space between the outer surface of the needle and the inner surface of the catheter 42.

[0073] Figure 5 and Figure 6 Another example of a continuous flashing indicator 80 according to one embodiment is shown, wherein an absorbent component 86 capable of absorbing blood or other desired bodily fluids is wrapped / decorated around a portion of the outer surface of a needle 16 to cover the notch 18 of the needle. Figure 1I , Figure 1J Cotton, gauze, fabrics, wood products, hydrophilic materials, mesh materials, polymer materials, polyesters, woven materials, and other suitable substances—both natural and synthetic—are examples of materials that can be used for absorbent components. In one embodiment, the absorbent material is woven into a fabric such that blood fills the spaces between the woven materials. This allows for the amount of expansion of the absorbent material and the speed at which blood passes through it. It should be noted that the expansion of the absorbent material can be radial, longitudinal, a combination of both, etc.

[0074] The absorbent component preferably has a color different from red to indicate when blood has been absorbed. In one embodiment, a translucent cover 88, comprising a thermoplastic or other suitable material, may optionally be placed on the absorbent component 86 to cover the absorbent component and isolate the blood absorbed therefrom.

[0075] When blood enters a blood vessel through the distal end 16B of the needle 16, it travels proximally along the needle lumen between the inner surface of the needle and the outer surface of the guidewire 22 disposed within the needle lumen. Upon reaching the notch 18 defined in the needle 16, a portion of the blood passes through the notch and is absorbed by the absorbent component 86, which changes color due to the absorption of blood. This indicates to the user that the distal end 16B of the needle is properly positioned in the blood vessel. As the distal end 16B remains in the blood vessel, blood continues to be absorbed by the absorbent component 86, causing the absorbed blood to travel along the length of the absorbent component, thereby providing continuous blood flash indication. Figure 7 The diameter of the absorbent member 86 is shown to be variable; therefore, modifications to what has been shown and described herein are conceivable. In another embodiment, it is understood that the absorbent material may be enlarged in size when used to absorb blood or other fluids.

[0076] Figure 30A and Figure 30B It shows Figure 5 and Figure 6 Various details of variations of the blood flash indicator 80 are provided, wherein the absorbent member 86 comprises an absorbent material strip, the first portion of which is disposed above a notch in the needle 16, such as a first needle notch 83. The first portion of the absorbent material strip is connected to a second portion of the absorbent material strip extending proximally from the first notch 83, although the second portion may also extend in other directions and may have other shapes, sizes, etc. The second portion of the absorbent material strip is secured to the inner surface 70A of the housing cavity 70 and is connected by a fastener 180 covering the first portion of the first notch 83, which may also include a portion of the absorbent material. With this configuration, the absorbent member 86 absorbs blood (or other fluid) flowing out of the lumen 17 of the needle 16 through the first notch 83, such as when the distal end 16B of the needle is positioned within a patient's vein. As it continues to flow out of the first notch 83, the blood will be continuously absorbed by the absorbent member 86 and travel from the first portion of the absorbent material through the fastener 180 and proximally along the absorbent material strip, thereby providing a continuous flash indicator to the observing user. In one embodiment, the tether 180 is breakable to allow the needle 16 to retract into the housing 12. Upon retraction of the needle 16, the tether 180 will disengage, allowing a second portion of the absorbent material secured to the inner surface 70A of the housing cavity to remain in place. In one embodiment, this is combined with… Figure 30A and Figure 30BThe flash indicator 80 may be included in the flash chamber, for example, such as Figure 4 The flashover chamber 82 is shown. The absorption component can be made of various materials, including composites. Figures 5 to 7 The materials mentioned above.

[0077] Figures 8A to 8H Details of a catheter insertion device 10 according to another embodiment are shown, including a housing 12 in which a needle 16, secured within the housing by a needle hub 14, extends distally from the housing. As shown, a catheter 42 is removably positioned above the needle 16, such that the needle passes through the hub 46 and the catheter body 44. A guidewire 22 is initially positioned within the lumen of the housing and the needle 16 and can be selectively advanced.

[0078] The insertion device 10 includes a propulsion assembly 120 for selectively advancing the guidewire 22 and the catheter 42. The propulsion assembly 120 includes finger pads 28 slidably connected to the housing 12. Figure 8E and 8F As shown, the finger pad 28 is part of the telescopic portion 90 and can slide distally to push the guidewire 22 distally out of the distal end 16B of the needle 16. Once the guidewire 22 has been fully extended distally, further distal sliding of the finger pad 28 causes a portion of the telescopic portion 90 to engage the catheter hub 46. Figure 8G ) and move catheter 42 distally until the telescopic portion is fully extended ( Figure 8H At this point, the catheter 42 can be removed from the insertion device 10, and the telescopic portion 90 has extended sufficiently to cover and enclose the distal end 16B of the needle 16, thereby protecting the user from accidental needle pricks. According to one embodiment, as described herein... Figures 8A to 8H The operation of the insertion device 10 enables it to be used to access blood vessels within the patient's body, deploy guidewires and catheters into the vessels, and cover the needle 16 after use. It should be noted that... Figures 8A to 8H An example of an insertion device that uses a single finger pad and telescopic component to fully advance the guidewire and catheter is shown.

[0079] Figures 9A to 9G Details of a needle safety member 100 for use with a device having a needle, such as an insertion device discussed herein, are shown. As shown, the needle safety member 100 is operatively attached to the needle 16 and disposed within a housing 101. Figures 9E to 9G The needle safety component includes a locking element 102, which is implemented herein as a flat, elongated metal strip, wherein a wave-shaped spring element 104 is formed at one proximal end, and a hook portion 108 as a cam follower is formed at the opposite end. A D-shaped hole 106 is defined through the middle of the locking element 102, and the needle 16 initially passes through the hole and through the guide tube 42, as... Figure 9A and Figure 9BAs shown. Other hole shapes are also possible.

[0080] like Figure 9E As shown, the cam 110 is rotatably located within the housing 101 and may include a hub engagement portion 112, a biasing portion 114, and a locking portion 116. Prior to actuation, the needle safety member 100 is configured as follows: Figure 9E As shown, a needle safety component is positioned above the needle 16, allowing the needle to pass through the hole 106. The cam 110 rotates such that its hub engagement portion 112 engages the threaded portion of the hub 46 of the guide tube 42 to maintain engagement between the guide tube and the needle safety component. A bias portion 114 of the cam 110 also engages a portion of the guide tube hub 46 to further maintain engagement between the hub and the cam. It should be noted that the spring element 104 is compressed relative to the inner surface of the housing 101, and the hook portion 108 of the locking element 102 is disposed within the locking portion 116 of the cam 110.

[0081] Once catheter 42 has been placed in the patient's body, needle 16 is withdrawn from the catheter and pulled out from hole 106 in locking element 102, while catheter hub 46 disengages from cam 110, causing cam to rotate counterclockwise. This rotation of cam 110 causes hook portion 108 of locking element 102 to disengage from locking portion 116 of cam 110 and slide upward relative to the side of cam, as... Figure 9F As shown. This allows the spring element 104 to be released from its compressed state (as shown). Figure 9E As shown), thus the moving hole 106 is not aligned with the pin 16. Figure 9E (as shown), and advantageously prevents the needle from reappearing in the housing 101. The distal end 16B of the needle 16 is covered to prevent it from being touched by the user.

[0082] Figures 10 to 12 Various examples of configurations of the guidewire 22 according to exemplary embodiments are shown, which allow blood to pass more easily through the lumen 17 of the needle 16. Figure 10 In the cross-sectional view, for example, guidewire 22 is shown positioned within the lumen 17 of needle 16. Guidewire 22 defines a flat strip or generally rounded rectangular cross-sectional shape, which, for example, when the distal end 16B of needle 16 enters a patient's vein or other blood-carrying vessel, releases space within the needle lumen 17 to allow blood to pass through. This, in turn, facilitates blood flow into blood flash indicators, such as those shown and described herein.

[0083] Figure 11 A cross-sectional configuration of guidewire 22 according to another embodiment is shown, wherein the cross-sectional view of the guidewire shows two longitudinal notches 117 defined in the guidewire profile. Figure 12 Three notches 117 defined in the cross-sectional profile of guidewire 22 are shown. These and other guidewire configurations can therefore be envisioned.

[0084] Figures 13 to 17 Various examples of configurations of the distal end 22B of the guidewire 22 are shown, configurations designed to provide a damage-resistant end to prevent injury to blood vessels during catheter insertion. For example, Figure 13 A guidewire 22 extending from the distal end 16B of the needle 16 is shown. The distal portion of the guidewire 22 includes a coiled configuration near the distal end 22B of the guidewire. Figure 14 The diagram shows a guidewire configuration with a J-shaped tip, where the distal end 22B of the guidewire folds back towards itself to form the J-shaped tip. Figure 15 In this configuration, a thermoplastic or metal ball 122 is fixed to the distal end 22B of the guidewire 22. Figure 16 In the middle, a three-dimensional stirrer-shaped end 126 is provided at the distal end 22B of the guidewire 22. Figure 17 Another configuration is shown in which the distal end 22B of the guidewire includes a ball attached thereto, and the distal portion of the guidewire 22 is in a coiled configuration. Therefore, these and other modifications to the guidewire 22 are conceivable. Note that in one embodiment, the guidewire 22 is made of nitinol or other suitable material, as is conceivable.

[0085] Figure 18 A propulsion member of a catheter insertion device 10 according to another embodiment is shown, wherein the propulsion member includes an outwardly extending wing 130 at its proximal end, the outwardly extending wing being configured to prevent the propulsion member from re-entering the housing of the insertion device after full extension of the propulsion member has been performed. This is merely one example of a mode that prevents accidental re-entry of the propulsion member.

[0086] Figure 18 Also shown is a continuous blood flash indicator 80 according to one embodiment, wherein an elongated channel 134 is defined on a surface portion of the advance member 48, thereby communicating fluidly with the lumen of the needle 16 of the insertion device 10. The channel 134 is shaped to define a pathway 136, such as a tortuous pathway, for example, along which blood present in the lumen of the needle 16 can travel after exiting the needle. Although various different pathway designs are possible, Figure 18 The passage 136 shown defines a reciprocating pattern along the top of the cylindrical segment of the propulsion member 48. The user can observe the blood within the passage 136, defined by channel 134, to confirm that the distal end of the needle 16 is positioned in a patient's vein or other desired blood vessel. Because the passage 136 is relatively long, the progression of blood flow within the passage allows the flash indicator 80 to function as a continuous flash indicator. It is understood that the channel and passage can be formed using one of a variety of processes, including molding, machining, etc.

[0087] In view of the above, Figure 19A continuous flashing indicator 80 according to another embodiment is shown, wherein a channel 134 defines a wavy reciprocating passage 136 on the surface of the advance member. As previously described, the distal end of the channel 134 is in fluid communication with the lumen of the needle of the insertion device (or other medical device), allowing blood to exit the needle lumen and enter the passage 136 defined by the channel. Although shown herein as defined on the advance member 48 of the catheter insertion device, the channel 134 may be included in other structures, including the hub or other portion of the catheter, the housing of the catheter insertion device / medical device / component, valve assemblies, etc. Furthermore, although shown herein as defined on the surface of the advance member, in other embodiments the channel may include at least a portion of a tunnel or passage defined below the surface of the advance member / medical device / component. In another embodiment, the passage may be covered by a translucent cover or other covering.

[0088] Figure 20 A continuous flash indicator 80 according to another embodiment is shown, wherein channel 134 defines a main branch path 136. Figure 21 and Figure 22 In the middle, the propulsion component 48 includes a relatively thin distal portion of the propulsion component ( Figure 21 ) and relatively thick parts ( Figure 22 The upper limit is the channel 134 of the reciprocating path 136. Figure 23 Channel 134 is shown as a toothed passage 136 defining the periphery of the distal portion surrounding the propulsion member 48, while Figure 24 The passage is shown as a zigzag pattern defined at an angle. And... Figure 25 In this context, channel 134 defines the converging reciprocating path. Therefore, these and other path designs, including circular, spiral, etc., can be envisioned.

[0089] It is understood that various other configurations are contemplated for the continuous flashing indicator 80 and its forming passage. For example, the flashing indicator may be included on / with the catheter hub 46, such that blood travels through the lumen 17 of the needle 16 to the catheter hub and into the flashing indicator. In yet another embodiment, the flashing indicator 80 is included as a removable component temporarily attached to the catheter hub 46 or other parts of the insertion device 10. It is further understood that the flashing indicator described herein can also be used to indicate, for example, the presence of other fluids (including other bodily fluids) in the needle. Thus, these and other modifications are contemplated.

[0090] Figures 26A to 26D Details of a catheter insertion device 10 according to another embodiment are shown, wherein, for clarity, the housing 12 has been removed from... Figures 26A to 26CRemoved from view. The insertion device 10 here includes a needle 16 extending distally from the housing 12, wherein the conduit 42 is removably disposed above the needle such that the needle passes through the hub 46 and the conduit body 44. The guidewire 22 is initially disposed within the lumen of the housing and the needle 16 and can be selectively advanced.

[0091] The insertion device 10 includes a propulsion assembly 120 for selectively advancing the guidewire 22 and the catheter 42. The propulsion assembly 120 includes a propulsion slide 140, which in turn includes a finger pad 148 slidably connected to the housing 12. The propulsion assembly also includes a guidewire carriage 124 from which the guidewire 22 extends distally to enter the needle 16. A tail end member 158 is also included at the distal end of the housing 12 and is used to push the catheter 42 distally, as will be discussed.

[0092] The initial position of the catheter insertion device 10 is as follows: Figure 26A As shown (excluding the omitted housing 12 for clarity), the pusher slide 140 and the guide wire slide 124 are connected together, as... Figure 26C As shown. Specifically, an arm 152 extending distally from the guide wire carriage 124 is connected to an angled protrusion 150 of the advance slide 140 via a notch 154 defined by the arm. Note that the arm 154 is biased downwards, which will cause the arm to disengage the notch 154 from the angled protrusion 150; however, the housing 12 in Figure 26A The position shown is shaped as a constraint arm to maintain engagement with the angled protrusion.

[0093] When the user manually engages the finger pad 148 and slides the push slider 140 to the distal end... Figure 26B In the position shown, the above configuration allows the advance slide and guide wire carriage 124 to move distally in conjunction. As in other embodiments, this movement allows the guide wire 22 to fully extend from the distal end 16B of the needle 16. At this point, since the arm 152 is no longer constrained by the housing 12 (or other suitable structure) to maintain engagement with the angled protrusion, the notch 154 of the downwardly biased arm 152 disengages from the angled protrusion 150. Therefore, further distal movement of the guide wire 22 through the guide wire carriage 124 is prevented. In one embodiment, a locking mechanism may be included to lock the guide wire carriage 124 in place. This process is reversed by sliding the advance slide 140 proximally, causing the guide wire carriage 124 to re-engage with the advance slide by re-engaging the notch 154 of the arm 152 with the angled protrusion 150.

[0094] Next, the advance slide 140 slides further distally via the finger pad 148 to engage the tail piece 158, which in turn pushes the catheter 42 distally away from the needle 16 and into the patient's body as needed. Once fully extended distally, the advance slide 140 covers the distal end 16B of the needle 16, thereby protecting the user. Thus, this embodiment illustrates an example of an insertion device that can fully advance the guidewire and catheter using a single advance assembly.

[0095] Figures 27A to 27E Details of a catheter insertion device 10 according to another embodiment are shown, wherein the top of the housing 12 has been removed for clarity. The insertion device 10 here includes a needle 16 extending distally from the housing 12, wherein a catheter 42 is removably disposed above the needle, such that the needle passes through a hub 46 and a catheter body 44. A guidewire 22 is initially disposed within the lumen of the housing and the needle 16 and can be selectively advanced.

[0096] The insertion device 10 includes a propulsion assembly 120 for selectively advancing the guidewire 22 and the catheter 42. The propulsion assembly 120 includes a guidewire rod, which in turn includes a finger pad 148 slidable along a portion of the length of the insertion device housing 12. Two grips 162 are disposed near the distal end of the insertion device 10 to assist the user in gripping the insertion device.

[0097] The insertion device 10 also includes a catheter slide 168 that slides distally within the housing 12 to advance the catheter 42 distally during catheter insertion using the insertion device. The catheter slide 168 includes a pair of wings 166 that interact with the guidewire rod 144 to advance the catheter after the guidewire 22 has been fully advanced.

[0098] The initial position of the catheter insertion device 10 is as follows: Figure 27A As shown (excluding the omitted top housing portion of housing 12 for clarity), the guidewire 144 and its finger pad 148 have not yet been advanced distally. As in other embodiments, the user manually slides the finger pad 148 distally, causing the guidewire 144 to push the guidewire 22 distally out of the distal end 16B of the needle 16. Once the guidewire 22 is fully extended, the thinned portion 164 of the guidewire 144 is positioned near the wing 166 of the catheter slide 168, as... Figure 27B As shown. Positioned in this way, the thinned portion 164 of the guide rod 144 is continuously pressed radially outward by the guide rod up to this point. Figure 27C The wing 166 contracts radially inward. Figure 27D This allows the catheter slide 168 to be advanced distally via further distal sliding movement of the guide rod's finger pad 148, such as... Figure 27EAs shown. If necessary, this distal advancement of the catheter slide 168 pushes the catheter 42 distally away from the needle 16 and into the patient's body. Thus, this embodiment illustrates another example of an insertion device capable of fully advancing the guidewire and catheter using a single advancement assembly.

[0099] Figure 28 It shows Figures 27A to 27E The continuous flashing indicator 80 of the catheter insertion device 10 shown includes a channel 134 defining a passage 136, which is implemented as a spiral disposed within the housing 12 around the distal portion of the propulsion assembly 120.

[0100] Figure 29 Details of a catheter insertion device 10 according to another embodiment are shown, including separately deployable components: a guidewire advancement assembly 20 including a guidewire rod 24 and a catheter advancement assembly 40 including a protrusion 172 and multiple telescopic sections 170. During use of the insertion device 10, the guidewire 22 is manually extended distally via the guidewire rod 24, after which the catheter 42 is manually extended distally via the catheter advancement assembly 40 and the included protrusion 172. The telescopic sections 170 hold the catheter advancement assembly 40 attached to the housing 12 and also help to cover the needle to prevent accidental contact by the user. Note that although two are shown here, one, three, or more telescopic sections 170 may be used. Thus, this embodiment illustrates an example of an insertion device in which the guidewire and catheter can be fully advanced using separate advancement assemblies.

[0101] It should generally be noted that in one implementation, one or more advance components may be configured to prevent distal advancement of the catheter before the guidewire is fully advanced distally. In other implementations, a single advance component is used to advance both the guidewire and the catheter. For example, the finger pad of the advance component may move a first distance to advance the guidewire distally, thereafter automatically or otherwise disengaging / blocking further guidewire advancement, and initiating distal advancement of the catheter when the finger pad moves a second distance, such as... Figures 26A to 26D As shown. In another embodiment, a single finger pad moves a first distance to advance the guidewire distally, then moves a second distance to continue advancing the guidewire distally, while simultaneously advancing the catheter distally, as shown. Figures 27A to 27E As shown. Consider these and other possible configurations.

[0102] Embodiments of the present invention may be embodied in other specific forms without departing from the spirit of this disclosure. These embodiments should be considered in all respects as exemplary only and not restrictive. Therefore, the scope of these embodiments is indicated by the appended claims rather than the foregoing description. All variations falling within the meaning and scope of equivalents to the claims are to be covered by the scope of the claims.

Claims

1. A needle assembly, comprising: A needle that defines the lumen of a needle tube; A notch defined in the sidewall of the needle allows blood to pass through the needle lumen when the open distal end of the needle is positioned in a blood vessel supplying blood to the patient. as well as A flashing indicator is configured to indicate the presence of blood within the needle lumen when the open distal end of the needle is positioned in a patient's blood delivery vessel. The flashing indicator includes absorbent material disposed around the needle such that it is positioned over and covers the notch. The absorbent material is configured to absorb blood passing through the notch from the needle lumen, such that the absorbed blood is observable by the user of the needle assembly.

2. The needle assembly of claim 1, wherein the absorbent material is configured such that blood flows continuously along the absorbent material, and the open distal end of the needle is disposed in the patient's blood-carrying vessel.

3. The needle assembly of claim 1, wherein the absorbent material is generally cylindrical and comprises at least one material selected from natural and synthetic materials.

4. The needle assembly of claim 1, wherein the absorbent material extends proximally along the outer surface of the needle from the notch.

5. The needle assembly of claim 1, wherein the absorbent material comprises cotton and the absorbent material is covered by a cover.

6. The needle assembly of claim 5, wherein the cover comprises a polymer material.

7. The needle assembly of claim 1, wherein the absorbent material is configured to expand in at least one of the radial and longitudinal directions when absorbing fluid.

8. The needle assembly of claim 1, wherein a marker is placed near the absorbent material and configured to measure the amount of blood absorbed by the absorbent material.

9. A needle assembly comprising: A needle defining a lumen, the needle being at least partially disposed within a housing; A notch defined in the sidewall of the needle allows blood to pass through the needle lumen when the open distal end of the needle is positioned in a blood vessel supplying blood to the patient. as well as A flashing indicator, configured to indicate the presence of fluid in the needle lumen when the open distal end of the needle is positioned in a patient's blood delivery vessel, the flashing indicator comprising absorbent material disposed around the needle and configured to absorb fluid passing through the needle lumen via the notch, such that the absorbed fluid is observable by the user of the needle assembly, the absorbent material comprising: A first portion is positioned close to the notch, such that the first portion of the absorbent material is positioned above and covers the notch; The second portion attached to the inner surface of the housing; and The tethering portion that interconnects the first and second portions of the absorbent material.

10. The needle assembly of claim 9, wherein the needle is retractable into the housing, and the tether portion is configured to disengage upon retraction of the needle, such that the second portion of the absorbent material remains on the inner surface of the housing.

11. The needle assembly of claim 9, wherein a portion of the housing adjacent to the second portion of the absorbent material is translucent so that the user can see the fluid absorbed by the second portion of the absorbent material.

Images