JP6147344B2 - Needle guard - Google Patents

Description

[Cross-reference of related applications]
This application is a continuation-in-part of US patent application Ser. No. 13 / 037,164, filed Feb. 28, 2011.

The invention disclosed in the present application relates to a safety needle guard ( safety needle guard, needle safety guard, injection needle safety guard, needle safety device, injection needle safety device, injection needle safety protection device ) .

Many US patents describe several safety IV (intravenous and intravascular) catheters ( safety IV catheters, protective IV catheters, IV catheters with safety devices ) , in those catheters after use the distal tip of the needle (distal tip) are to some extent provided with a function to protect, they patent, U.S. Patent No. 5,135,504 of McLees U.S. Patent No. 5,797,880 of Erskine, Woehr U.S. Pat. No. 6,287,278, Bialecki et al. U.S. Pat. No. 6,652,486, McGurk U.S. Pat. No. 7,291,130, Rhad et al. U.S. Pat. No. 7,303,548, US Pat. No. 7,731,687 to Menzi et al. And US Pat. No. 7,828,774 to Harding et al.

Some of the conventional safety catheters (safety catheters, IV catheters with protective functions, IV catheters with safety devices) have one or more drawbacks, which can be used by medical personnel and others. , After the needle tip is covered by a safety mechanism, percutaneous or non-percutaneous blood or body fluid exposure (patient blood or body fluid adheres to medical personnel) Could potentially be at risk. For many practical safety IV catheters, the needle tip itself is covered after its use, but the entire needle tip is not fully contained after its use, As a result, blood or bodily fluid remaining in the lumen of the needle may leak into the workplace or otherwise escape and contact the health care worker. For example, scattered blood can enter the mucosal area of the eyes, nose, or mouth of a health care worker close to the location of the scattering. When such exposure occurs, then reports are performed, further, post-exposure treatment, disease prevention (prophylaxis) and continuity management (follow Stay up-) is performed, whereby the expense for the facility, It causes anxiety for the individual medical staff with the blood in question. In addition, for some commercially available needle guards, inadvertent accidents can occur if the part can no longer protect or shield the contaminated needle tip. When this happens, the needle guard can simply become useless.

1-5 show a safety needle guard 10 similar to that disclosed in US Pat. No. 6,287,278. As shown in FIG. 1, the needle guard 10 is composed of a part of a certain material, and is formed so as to have a plurality of configurations (a plurality of shapes) shown in FIGS. Has been. 2 and 3 show the needle guard 10 in different side views and with the distal tip 18 of the needle 15 in an unprotected ready position. 4 and 5 show that the needle guard 10 is actuated so that the needle guard 10 covers the distal tip 18 in a different side view and covers the distal tip 18. The state is shown. As shown in FIGS. 4 and 5, the very tip of the distal tip 18 of the needle 15 is protected, but the open lumen 17 in the bevel 16 of the needle 15. But still exposed. Another problem associated with this needle guard 10 is that the arms 11 and 12 of the needle guard arms 11 and 12 have their arms 11 and 12 respectively pushed out in order to push them outward. And that force can be applied to several positions. This can result in the distal arm segments 13 and / or 14 not protecting the distal tip 18.

According to some embodiments, an IV (Intravenous, Intravascular) catheter assembly is provided, the IV catheter assembly having a hollow body portion, the hollow body portion comprising: A catheter having a proximal end and a distal end and defining an interior space, and a proximal end and a distal end, wherein the proximal end of the catheter is A needle connected to the proximal end of the catheter hub and having a needle shaft and a distal tip, the ready position and the retracted position; At a position where the needle is stored in the needle guard), and in the preparation position, the distal tip of the needle extends distally from the distal end of the catheter. On the other hand, in the retracted position, the distal tip of the needle is placed in a position located in the proximal direction with respect to the proximal end of the catheter, and the needle shaft has a profile changing portion where the profile changes. (A change in profile) and a needle guard having an arm, the arm extending in a distal direction from the base, the base having an opening formed therein The needle guard is slidably mounted on the needle shaft in a state where the needle shaft passes through the opening formed in the base, and the opening is Engaging the profile change of the needle shaft, thereby moving the needle proximally relative to the needle guard Having a size that limits movement, the arm having an elastic material and having a proximal section, a central section and a distal section, the distal section of the arm having the needle in the ready position And is pressed against the side of the needle shaft, the needle guard further including an elongated member, the longitudinal member having its proximal and distal ends The longitudinal member extends distally from the same or near position as the base and the needle moves between the ready position and the retracted position. Is slidable along the needle shaft as it is moved, and the longitudinal member has a length that is determined by the profile changing portion. The entire distal tip of the needle is disposed within the longitudinal passage of the longitudinal member when substantially engaged with the opening in the base and distal of the arm It is realized that the section is detached from the needle shaft and moves radially inward, thereby at least partially covering ( covering, protecting ) the distal end of the longitudinal member. The longitudinal member restricts the needle from moving axially relative to the needle guard when the arm at least partially covers the distal end of the longitudinal member. IV catheter assembly with sufficient rigidity to define the limit.

  In accordance with some other embodiments, an IV (intravenous, intravascular) catheter assembly is provided, wherein the IV catheter assembly is a catheter hub having a hollow body portion, the hollow body portion. Is a catheter having a proximal end and a distal end and defining an interior space, and a proximal end and a distal end, the proximal end of the catheter being connected to the catheter hub. A needle coupled to the proximal end and having a needle shaft and a distal tip, the needle being movable between a ready position and a retracted position; A distal tip extends distally from the distal end of the catheter, while in the retracted position, the distal tip of the needle is located proximal to the proximal end of the catheter. And the needle shaft includes a profile changing portion whose profile changes, and a needle guard having first and second arms, the first and second arms being remote from the base. The base has an opening formed therein, and the needle guard is in a state in which the needle shaft passes through the opening formed in the base. A slidably mounted on the needle shaft, the opening engaging the profile changing portion of the needle shaft, thereby moving the needle proximally relative to the needle guard Each of the first and second arms has an elastic material and has a proximal section and a central section. And the first and second arms extend from different positions of the base and intersect each other along a respective intermediate section, whereby the first and second arms Each distal section of the two arms is deployed when the needle is in the ready position and is pressed against each side of the needle shaft, the needle guard further including a longitudinal member; The longitudinal member has a through passage extending between its proximal and distal ends, the longitudinal member extending distally from the same or near position as the base, and the needle Slidable along the needle shaft as it is moved between a ready position and a retracted position; The material has a length such that when the profile change portion substantially engages the opening in the base, the entire distal tip of the needle is the length of the longitudinal member. A distal section of at least one of the first and second arms is moved away from the needle shaft and moved radially inwardly, thereby being positioned in a through-passage, It is intended to at least partially cover (clog, protect) the distal end of the longitudinal member, wherein the longitudinal member has at least one of the first and second arms. Stiff enough to restrict the needle from moving axially relative to the needle guard when covering at least partially the distal end of the longitudinal member IV catheter assembly having sex.

  According to some embodiments, the needle guard has a single structure such that the elongate member is integrally formed with the base of the needle guard.

  According to some embodiments, the needle is stopped by a part or feature in the retracted position, the part or feature being incorporated into the distal end of the longitudinal member, or other method Thus, the longitudinal member is disposed at the same position as or near the distal end of the longitudinal member.

According to some embodiments, the proximal section of said elongate member, said needle guard to a small diameter portion smaller in diameter than the other portion (reduced diameter portion) and / or truncated cone-shaped portion (frustoconical Portion) Above has what is available to assist in self-centering the needle.

According to another embodiment, a safety needle device is provided, the safety device comprising a needle having a needle shaft and a distal tip. shaft is a profile change unit profile is changed at the distal tip needle guard is caused to transition between the one having a position in the vicinity, a ready state (ready state) and the working state (activated state) of, In the ready state, the distal tip of the needle is in an unprotected state where the distal tip is not protected by the needle guard, but in the working state the distal tip of the needle A tip in a protected state in which the distal tip is protected by the needle guard; The base includes an arm extending in a distal direction from the base, the base having an opening formed therein, and the needle guard includes the opening formed in the base. Slidably mounted on the needle shaft with the shaft passing therethrough, the arm having an elastic material and having a proximal section, a central section and a distal section; the needle guard further comprising: A longitudinal member that extends distally from the same or near position as the base, and wherein the needle guard is in the ready position and the working state. The length of the needle shaft along its side as it is moved between its activated position And the longitudinal member has a proximal end, a distal end, and a through passage extending between the proximal end and the distal end, the through passage being slidable along the needle shaft A first portion located at the same position as or near the proximal end of the longitudinal member restricts the needle from moving proximally with respect to the needle guard. The length of the longitudinal member has a length, the length of the longitudinal member being defined by the profile change portion of the through-passage. When engaging with the first part, the entire distal tip of the needle is disposed so as to be placed in the through-passage of the longitudinal member. The member includes a proximal section and Having a distal section, the proximal section of the longitudinal member having a base on the proximal section of the longitudinal member (on, in contact) at a first position and distally from the first position Positioned within the opening of the base in a slidable manner between a second position, the proximal section of the elongate member is configured to move the first when the needle guard is in the ready state. When the needle guard is in the second position when the needle guard is in the working state and the needle guard is in the ready state, the distal section of the arm is the longitudinal member On the distal section of the longitudinal member (on, in contact) and in the vicinity of the distal end of the longitudinal member, wherein at least a portion of the distal section of the arm is the longitudinal The needle guard is pressed against the outer side (outer side surface) of the member, and when the base moves from the first position to the second position, the needle guard changes from the preparation state to the operation state. The distal section of the longitudinal member in a distal direction along the outer side of the distal section of the longitudinal member Wherein the distal section of the arm is moved radially inward to at least partially cover (cover, occlude, protect) the distal end of the longitudinal member; A longitudinal member is formed when the distal section of the arm at least partially covers (covers, occludes, protects) the distal end of the longitudinal member. It has sufficient rigidity to limit to move axially (the restrict, defining the movement limit) relative.

  In some other embodiments, a number of needle guards are provided, in which a number of biasing members are one or more of the needle guards. Acting on the other arm, thereby assisting the biasing of the arms against the needle shaft or the longitudinal member, which is performed when the needle guard is in the ready state. It may be broken.

  Many other embodiments are disclosed herein and are considered subject of the present invention. Furthermore, it is important to note that some inventions disclosed herein are not limited to safety IV catheters, but apply to any of a variety of needle related products. These needle-related products include guidewire introducers, blood collection devices, etc., but they include It is not limited.

1-5 show one conventional needle guard.

FIGS. 6A-6C illustrate one flat stock that can be used to form a plurality of needle guards as disclosed herein and contemplated as the subject of the present invention. 2 shows a plurality of embodiments of the material in a flat unfolded state.

7-10 illustrate one needle guard assembly according to one embodiment.

Figures 11-17 illustrate a plurality of protective longitudinal members according to various embodiments.

18 and 19 show one needle guard assembly according to another embodiment.

20-23 illustrate one needle guard assembly according to another embodiment.

FIG. 24 illustrates one needle guard assembly according to another embodiment.

Figures 25A-25D illustrate a plurality of needle guard longitudinal members according to various embodiments.

FIGS. 26-29 show one needle guard assembly according to another embodiment. FIG. 30 shows the needle guard assembly of FIGS. 26-29. FIG. 31 shows the needle guard assembly of FIGS. 26-29.

32-34 show one needle guard assembly according to another embodiment.

Figures 35-37 illustrate one needle guard assembly according to another embodiment.

Figure 39-Figure 40 shows one safety intravenous (intravenous, intravascular indwelling) catheter assembly according to another embodiment.

FIG. 38 illustrates a safe intravenous catheter assembly according to one embodiment.

  FIG. 41 illustrates a needle guard assembly according to another embodiment.

42A-42D illustrate one safe intravenous catheter assembly according to another embodiment.

43A-43D show how the needle guard of FIG. 42 can take action.

44A-44D show one needle guard according to another embodiment being used in an intravenous catheter assembly.

45A-45D show one needle guard according to another embodiment being used in an intravenous catheter assembly.

FIG. 46 shows a longitudinal member according to one embodiment.

  FIG. 47 illustrates a longitudinal member according to one embodiment.

FIG. 48 illustrates a longitudinal member according to one embodiment.
FIG. 49A shows one safe intravenous catheter assembly according to another embodiment.
FIG. 49B shows the safe intravenous catheter assembly of FIG. 49A.

FIG. 49C shows the safe intravenous intravascular catheter assembly of FIG. 49A. 49D shows the safe intravenous catheter assembly of FIG. 49A.

  FIG. 50 illustrates a longitudinal member according to one embodiment.

FIG. 51 shows a longitudinal member according to one embodiment.

  FIG. 52 illustrates a longitudinal member according to one embodiment.

  FIG. 53 illustrates a longitudinal member according to one embodiment.

  FIG. 54 illustrates a longitudinal member according to one embodiment.

  FIG. 55A illustrates a longitudinal member according to one embodiment.

  FIG. 55B illustrates a spring clip base according to one embodiment having a keyhole provided to receive the proximal end of the longitudinal member of FIG. 55A.

FIG. 56A shows a longitudinal member according to one embodiment.

  56B shows a spring clip base according to one embodiment having a keyhole provided to receive the proximal end of the longitudinal member of FIG. 56A.

  57A and 57B show a spring clip base according to another embodiment.

  58A-58C illustrate one longitudinal member having a seal member at the distal end thereof.

  FIG. 59 shows a seal member according to another embodiment.

FIGS. 60A-60C illustrate one needle guard assembly according to another embodiment that is incorporated within a guidewire introducer.

FIG. 61 illustrates a needle guard assembly according to another embodiment.

62A and 62B show one needle guard assembly according to another embodiment having spring means integrally formed with the spring clip. 62C and 62D show the needle guard assembly of FIGS. 62A and 62B.

63A, 63B, and 63D show one needle guard according to another embodiment. FIG. 63C shows the needle guard of FIGS. 63A, 63B and 63D.

FIGS. 64A-64C illustrate one needle guard according to another embodiment.

  FIG. 65 shows one needle guard according to another embodiment.

  66A-66C show one needle guard according to another embodiment.

67A and 67B show one needle guard according to another embodiment.

  68A and 68B show one needle guard according to another embodiment.

69A-69C show one needle guard according to another embodiment.

  70A and 70B show one needle guard according to another embodiment.

FIG. 71 shows one needle guard according to another embodiment.

  6-11 illustrate a needle guard 100 according to some embodiments. According to one embodiment, the first portion 110 of the needle guard 100 is manufactured from a flat material having elastic properties, as shown in FIG. 6A or 6B, and is used in multiple uses as shown in FIGS. Although having a shape for taking in-use configurations, the second portion 150 (shown in FIGS. 11 and 12) of the needle guard 100 defines a longitudinal member 152, which A through passage 153 extending between a proximal end (proximal end) 154 and a distal end (distal end) 156. 7 and 8 show the needle guard 100 in different side views, the needle guard 100 being located at a first axial position on the needle 130, where the needle 130 The distal end 134 is in an unprotected state. FIGS. 9 and 10 show the needle guard 100 in different side views, the needle guard 100 being in a second axial position on the needle 130, here the distal end 134. Those including the whole of the inclined portion (bevel, inclined surface, groove) 136 are in a protected state (protected, contained, not exposed).

In one embodiment, the first portion 110 of the needle guard 100 has first and second arms 101 and 102, each having elasticity, wherein each arm 101, 102 has a proximal end 103 and 104, central sections 105 and 106, and distal ends 107 and 108. When the needle guard 100 is in the first axial position, the respective lip segments 111 and 112 of the distal sections 107 and 108 are disposed on both sides of the needle shaft 131 and The first and second arms 101 and 102 extend distally from a plurality of different positions of the base 118 along the central sections 105 and 106 of the arms 101 and 102 so that they are pressed against both sides. Cross each other. The first portion 110 of the needle guard 100 is slidably mounted on the needle shaft 131, and the needle shaft 131 passes through the opening 119 formed in the base 118. In one embodiment, the opening 119 is sized to engage the profile change portion 132 on the needle 130, the purpose of which is when the needle guard 100 is in the second axial position. The purpose is to limit movement in the first direction between the needle 130 and the needle guard 100. The profile changing portion 132 is a crimp (crimp, pleat portion, wavy portion, crushing portion, embossed portion, crimping portion, obstruction portion) on the needle shaft 131 or an enlarged portion (see FIG. 33 and FIG. 35). (enlargement, enlarged portion, expanded portion, enlarged diameter portion) may be of any type.

As shown in FIG. 7, the longitudinal member 152, the ready position the needle guard 100 (ready position, said first axial position) when in the proximal end 154 of the longitudinal member 152 includes a base 118 While located at or near the same location, the distal end 156 of the longitudinal member 152 is disposed on the needle guard 100 with the lip segment 111 of the arm 101 located at or near the lip segment 111. . In some embodiments, the longitudinal member 152 is substantially coaxial with the needle 130, wherein the diameter or cross-section area of the through passage 153 is such that the longitudinal member 152 is the profile change portion 132. It is large enough to be able to slide over. In some other embodiments, the longitudinal member 152 is substantially coaxial with the needle 130, wherein the diameter or cross-sectional area of the entire through passage 153 or its proximal portion is the profile change portion 132. Is smaller than the cross-sectional area. In some embodiments, the cross-sectional area of all or part of the through-passage 153 is smaller than the cross-sectional area of the profile changing portion 132. In those embodiments, the through-passage 153 is the same as that shown in FIG. In addition, it is configured to be expandable (expandable) on the profile changing unit 132 (when trying to get over). In some embodiments, in the sections of the longitudinal member 152, the cross-sectional area of the through passage 153 is smaller than the cross-sectional area of the profile changing portion 132, and each section of the through passage 153 includes the profile changing portion 132. After crossing, it has elasticity to cause the cross-sectional area of the through passage 153 to contract inward. In some embodiments, as will be described in more detail below, only the proximal end 154 of the expandable member 152 (longitudinal member) has a reduced cross-sectional area than other sites. And its reduced cross-sectional area is elastically expandable on the profile change portion 132 (when trying to get over). During use, the longitudinal member 152 has a first portion 110 in a state associated with the needle guard 100 (in conjunction with, in conjunction, integrally), along the axial direction along the shaft 131 of the needle 130 Moving. In some embodiments, the longitudinal member 152 rides with the first portion 110 of the needle guard 100, at which time the proximal end 154 abuts the base 118 ( abut, you are hitting). In some other embodiments, the proximal end 154 of the longitudinal member 152 is attached to the base 118. In some other embodiments, the proximal portion or all of the longitudinal member 152 is integrated with the base 118.

  9 and 10 show a needle guard 100, which is in the second axial position on the needle 130, at which time the needle tip 134 is shown. And what includes the whole oblique part 136 is covered. In one embodiment, when needle guard 100 is moved over needle 130 and lip segments 111 and 112 are moved distally from needle tip 134, profile change 132 on needle 130 is at base 118. By engaging with the opening 119, the needle guard 100 is stopped at the second axial position. Several other embodiments for stopping are described below. The length of the longitudinal member 152 is selected as follows, with the selection being such that the profile change 132 engages an opening 119 in the base 118, for example, the distal tip 134 and the bevel of the needle 130. 136 is positioned so that it is entirely located within the through-passage 153 and at least one of the distal sections 107 and 108 of the arms 101 and 102 completely extends the distal end 156 of the longitudinal member 152. Or for disengagement with the needle 130 for the purpose of at least partially covering (covering, protecting), the engagement with the side of the needle 130 is released. It is done so that it is possible to move forward.

In one embodiment, as shown in FIG. 7, when the needle guard 100 is in the ready position (the first axial position), the distal section 107 of the arm 101 is relative to the needle axis (center line). The distal section 108 of the arm 102 is configured to have a second angle with respect to the needle axis when the needle guard 100 is in the ready position. At this time, the second angle is larger than the first angle. Furthermore, as shown in FIG. 9, when the needle guard 100 is in the second axial position, the distal section 107 of the arm 101, the vertical axis of the elongate member 152 (Longitudinal axis, the center line of the longitudinal members 152 ) And biased so as to take a positional relationship that is substantially perpendicular to. In some embodiments, the cross-sectional area of the distal section 107 covers the entire distal end 156 of the longitudinal member 152 (covers, covers, protects). ) Is large enough. In some other embodiments, less than all of the distal end 156 of the longitudinal member 152 is covered by the distal section 107.

  As described above, the distal end (distal section) 107 of the arm 101 is such that when the needle guard 100 assumes the second axial position, the distal end (distal section) 107 is downward / proximal. A force acting in the direction can be biased to act on the distal end 156 of the longitudinal member 152. In one embodiment, the biasing is achieved by an elastic hinge in the region (hinge) 117. Applying a force acting in the downward / proximal direction assists in the formation of a complete or partial seal, which has led to the needle guard 100 taking the second axial position. Later, it is possible to limit or prevent contaminants in the respective lumens of the needle 130 and the longitudinal member 152 from leaking out of the needle guard 100. In some embodiments, the distal end (distal section) 108 of the arm 102 has an angled angle with respect to the distal end (distal section) 107 and certain forces are applied to the distal end ( And is biased to act on the distal section) 107 and in a direction toward the distal end 156 of the longitudinal member 152.

  In some embodiments, the needle guard 100 forms part of an intravenous catheter (catheter assembly) 700, as shown in FIG. 117 and 116 are formed on arms 101 and 102, respectively, for the purpose of releasably securing needle guard 100 within catheter hub 702 when catheter assembly 700 is in the ready position. Engaging with one or more features 703 within the catheter hub 702.

As mentioned above, the problem with the conventional spring clip type ( a type that utilizes elastic clips ) needle guard devices is that several forces are applied to some of the several spring clip type arms. Acting on that part, which is why some distal arm sections (distal sections of the arms) are urged outward . This prevents some distal arm sections from protecting the needle tip after the needle guard has reached a protected position (protected position). There is a possibility of moving away from. To address this problem, in some embodiments of the present invention, the first portion 110 of the needle guard 100 is arm segments 113 and 114, each being completely or substantially linear. And the arm segments 113 and 114 are located proximal to the distal arm sections 107 and 108, respectively. As shown in FIG. 9, when the needle guard 100 takes the second axial position on the needle 130, the arm segments 113 and 114 abut against both sides of the outer surface of the longitudinal member 152, respectively, Arm segments 113 and 114 are positioned so that they are positioned laterally (laterally with respect to the side) at positions on either side of the outer surface of member 152. The arm segments 113 and 114 occupy several positions between the distal sections 107 and 108 and the intersection 126 of the arms 101 and 102 when the needle guard 100 is in the second axial position. Are arranged as follows. In one embodiment, arm segments 113 and 114 are positioned adjacent to distal sections 107 and 108, respectively, and spaced a distance away from intersection 126 of arms 101 and 102. Has been. In one embodiment, the distance D1 at which the arm segment 113 is distally separated from the intersection 126 is equal to or greater than L1 · sin β, where L1 is the intersection 126 and the arm 101 is Is approximately equal to the distance between the intersecting positions, and β is a straight line extending through the arm 101 and passing through the intersection 126 and perpendicular to the longitudinal axis (center line) of the longitudinal member 152. Is the angle between. Although not essential, the arm segments 114, substantially in the axial direction (Longitudinally, longitudinally) are aligned (aligned with, the position in the vertical direction coincide with each other) relative to the arm segment 113 so In addition, it is desirable to move away from the intersection 126 in the distal direction.

  In some embodiments, the respective width dimensions of arm segments 113 and 114 are substantially the same as the respective width dimensions of distal sections 107 and 108, respectively. In some other embodiments, as shown in FIG. 6B, arm segments 113 and 114 have a width dimension that is less than the width dimension of distal sections 107 and 108, respectively. In some other embodiments, one or both of the arm segments 113 and 114 can have an arcuate portion that is the outer curve of the longitudinal member 152. , Curvature portion, curvature, curvature of outer peripheral surface) at least partially match (confirm, conform in shape, fit, geometric fit). The effect of such an arrangement is that at least a partial conformal fit of arm segments 113 and 114 to the outer surface of longitudinal member 152 when an improper force is applied to one or both of arms 101 and 102. Confirmability means that the arm segments 113 and 114 act to increase the stability around the longitudinal member 152 (do not move freely around the longitudinal member 152). That is, the at least partial conformability described above is such that when an improper force is applied to the arms 101 and / or 102, the arms 101 and / or 102 are sideways over the outer surface of the longitudinal member 152. The possibility of slipping along the circumferential surface, which is the outer surface, in the circumferential direction thereof and on the outer surface in a direction away from the outer surface) is reduced. As an example, and with reference to FIG. 6A, the outer edges 121 and 122 of the arm segment 113 curve inwardly along the cutting lines 123 and 124, respectively, inward. , Whereby the outer edges 121 and 122 take a configuration that is partially curvilinear.

  The first portion 110 and the second portion 150 of the needle guard 100 can take any of a variety of configurations. Referring again to FIGS. 6A and 6B, in one embodiment, the respective central sections 105 and 106 of the arms 101 and 102 are narrow enough to accommodate the longitudinal member 152, at which time the first portion 110. 7-10, when formed to be spring-loaded clips (elastic clips), there is a clearance between the central sections 105 and 106 and the outer surface of the longitudinal member 152. . The broken lines in FIGS. 6A and 6B indicate a plurality of folding locations for generating a plurality of bends and / or a plurality of hinges during execution of the spring clip manufacturing method. Show.

In some embodiments, the elongate member 152 has one or more materials that are sufficiently rigid to withstand buckling during use. The one or more materials can be a variety of compositions of materials, such as metals, elastomers / plastics, braided structures, irregularly bundled structures ( random stranded structure), combinations thereof, and the like. The longitudinal member 152 can have a plurality of portions or sections that are coupled together to form the longitudinal member 152.

The longitudinal member 152 can be manufactured, for example, using a deep-draw fabrication process, in which the metal material is work hardened during the drawing process. hardened), which eliminates the need for a secondary heat treatment of the surface of the finished part. The elongate member 152 can further include, for example, an extruded portion of elastomer / plastic tubing (extruded product).

  According to some other embodiments, the through-passage 153 in the proximal portion of the longitudinal member 152 that is adjacent to or adjacent to the base 118 is smaller in cross-sectional area / diameter (smaller diameter) than the other portions. Due to the smaller cross-sectional area / diameter of such other portions, the proximal portion of the through passage 153 engages the profile change portion 132 on the needle shaft 131. In one embodiment, the aforementioned small diameter portion of the through passage 153 acts as a stopper in place of the opening 119 in the base 118, the purpose of which is to limit the movement of the needle guard 100 on the needle 130. Is set to the position in the second axial direction. In some other embodiments, a small diameter bush or sleeve is located at or coupled to the proximal end 154 of the longitudinal member 152 to act as a stopper. Can be done.

According to some other embodiments, the proximal portion of the longitudinal member 152 expands or bends over the profile change portion 132 in the manner shown in FIG. It has a material that can be flexed. In one embodiment, the proximal portion of the longitudinal member 152 has an elastic material that expands over the profile change portion 132 and constrains on the profile change portion 132 (at the same time). It is possible to apply a constraining / radial force. The advantage of such an embodiment is that after the needle guard 100 is positioned over the distal end of the needle 130, the radial constraining force acting on the profile change 132 is longitudinal. This means that the movement of the member 152 is limited. This is particularly advantageous when a complete or partial seal formed between the distal section 107 or arm 101 and the distal end 156 of the longitudinal member 152 is required. According to some other embodiments, the entire longitudinal member 152 comprises a flexible material that can be used as the longitudinal member 152 is slid or moved to the distal end of the needle 130. The longitudinal member 152 can be expanded or bent on the 130 profile changing portions 132.

  FIG. 13 is a side cross-sectional view illustrating one embodiment of the longitudinal member 152, which has a proximal portion 155 with a reduced inner diameter. The elongate member 152 may have an absorbent or porous inner coating / membrane / liner or similar member 158 that contacts the outer diameter of the needle 130. As the needle 130 slides or moves past the elongate member 152, it has a size that allows it to absorb or wipe blood or bodily fluid from the outer surface of the needle 130. The absorbent / porous member 158 may absorb blood or body fluid remaining in the lumen of the needle 130. In some embodiments, the absorbent / porous member 158 contains an agent, such as, for example, an antimicrobial agent or an antibiotic agent.

  FIG. 14 is a side cross-sectional view illustrating one embodiment of a longitudinal member 152 having a small diameter or frustoconical portion 159 at the proximal end 154 and a distal flange. An outwardly projecting collar 157 is provided at the distal end 156. According to one embodiment, the distal flange 157 provides a larger contact surface 179 whose purpose is to disengage the arm 101 when the needle guard 100 is in the second axial position on the needle 130. It is to facilitate the formation of a seal between the distal section 107 and the distal end 156 of the longitudinal member 152. In some other embodiments, when the needle guard 100 reaches the second axial position on the needle 130, the lip (lip segment) 111 engages the distal flange 157 and the arm 101 The distal flange 157 and the lip (lip segment) 111 of the arm 101 are configured such that the distal section 107 is secured to the distal end 156 of the longitudinal member 152. In such embodiments, the distal flange 157 is annular, continuous, or fragmented (segmented, rather than configured as a continuous body, divided into multiple segments. ing).

  FIG. 15 is a cross-sectional view showing one embodiment of the longitudinal member 152, which has a small diameter portion or a truncated cone portion 160 that has a smaller diameter than other portions. Acts as a transition to an end section or sleeve (proximal end section) 161. The elongate member 152 may further include a flange 157 that extends radially outward. In one embodiment, proximal end section 161 is used to attach proximal end 154 of longitudinal member 152 to base 118. The mounting can be accomplished by compression molding, stamping, pressing or other mechanical fastening methods. For example, the proximal end section 161 may be inserted into and secured within an opening 119 or other opening implemented in the base 118, such as a plurality of tabs or the like. Can be fragmented (segmented, divided into a plurality of segments rather than configured as a continuum). In some other embodiments, the shape and size of the proximal end section 161 allows the proximal end section 161 to be press fit into the opening 119 and secured. It is important to note that the longitudinal member 152 of the needle guard 100 is disclosed in this specification and considered as the subject of the present invention in any of a variety of other attachment methods or combinations thereof. It can be used to attach to the base 118. These methods can include the use of adhesives, soldering, welding, mechanical mounting, and the like. As will be described in detail below, in some embodiments, the longitudinal member 152 is integrally formed with the first portion 110 of the needle guard 100.

  The advantage of realizing a plurality of areas / sections having a small diameter along a portion of the longitudinal member 152 having a certain length is that the areas / sections are coaxially disposed on the needle 130. That the coaxial arrangement does not exist when the longitudinal member 152 is moved along the needle shaft 131 unless such a coaxial arrangement is realized. The frictional force or drag force will decrease. The areas / sections also assist in forcing or maintaining the longitudinal member 152 to have a coaxial positional relationship with the needle shaft 131.

FIG. 16 is a perspective view showing one embodiment of the longitudinal member 152, which has a large diameter distal portion 164 and a small diameter proximal portion 163. FIG. 17 is a cross-sectional view illustrating one embodiment of a longitudinal member 152 according to FIG. 16, wherein the longitudinal member 152 is an inner ring or cavity held within a cavity within the large diameter distal portion 164. The bushing 165, the inner ring or bushing 165, when the needle 130 is positioned coaxially within the longitudinal member 152 and when the needle 130 is slid or axially moved to pass through the longitudinal member 152. And wiping blood or body fluid from the outer surface of the needle 130. One advantage of the large diameter distal portion 164 is that the large diameter distal portion 164 collects blood or bodily fluid that is wiped from the outer surface of the needle 130 or emerges from the lumen of the needle 130 ( reservoir , The container to be accommodated). In one embodiment, the reservoir contains a coating or absorbent that absorbs the blood or body fluid. In one embodiment, the absorbent material occupies the entire reservoir or a large portion of the reservoir and is deformable to allow the distal end of the needle 130 to be introduced into the reservoir portion of the longitudinal member 152. Or has the possibility of penetration. In some embodiments, a seal is realized between the distal end of the longitudinal member 152 and the distal arm section 107, and in those embodiments, one or more openings are in the wall of the reservoir. The purpose is to prevent fluid locking phenomenon (hydraulic lock, the fixing of mechanical parts by incompressible fluid). In one embodiment, the one or more openings in the wall of the reservoir are small enough to prevent or block blood or bodily fluid from penetrating the wall.

  In some embodiments, an inner seal member or an outer seal member is provided at the same location as or near the proximal end 154 of the longitudinal member 152.

In some embodiments, the longitudinal member 152 is one or more sealed annular rings, ribs or segments, and profile changes as the needle guard 100 is advanced over the needle 130. Some have deformation or deflection on the part 132. In some embodiments, the elongate member 152 has a plurality of elongate encapsulated portions that are the entire length of the elongate member 152. Or it extends over some length. In such embodiments, the encapsulated structures (longitudinal encapsulated portions) can be formed by using extrusion. The encapsulating members (longitudinal encapsulating portions) contain a plurality of chemicals that interact with each other as the one or more encapsulating members expand on the profile change portion 132. In addition, the chemicals are caused to solidify to secure the proximal end 154 of the longitudinal member 152 to the profile change 132 of the needle 130.

As described above, a partial or complete seal at the intersection of the distal section 107 of the arm 101 and the distal end 156 of the longitudinal member 152 when the needle guard 100 is positioned in the second axial position. It may be required to form a seal. According to some embodiments, the inner surface of the distal section 107 is coated or laminated with a material, compound or agent, and the materials are: When the distal section 107 contacts the distal end 156 of the longitudinal member 152, the distal end 156 of the longitudinal member 152 contributes to the formation of a seal. Conversely, or in conjunction with coating or laminating the inner surface of the distal arm section 107 (in combination with), the distal end 156 of the longitudinal member 152 is used to form a seal. It is also possible to coat or laminate with contributing materials (materials, sealing materials), compounds (compounds, sealing compounds) or agents (agents, sealing agents). For example, in some embodiments, one or both of the distal section 107 and a distal end 156, an elastomer to form a total or partial sealing portion (-seal) between them member (Elastomer , Rubber-like elastic bodies), and deformable materials (formable materials, materials whose shape changes, deformable materials). Some other examples contain sticky substances or adhesives. Some other examples include at least a portion of an elastomeric O-ring on the distal end 156 of the longitudinal member 152 and at least a portion of the O-ring distal to the distal end 156. Extending to position, thereby including securing the O-ring so that it mates with the contact surface of the distal arm section 107. Several other sealing methods are also considered as objects of the present invention.

18 and 19 show a needle guard 200 according to another embodiment. The needle guard 200 is similar to that of the needle guard 100 described above, except that the end of the arm 102 is located at the segment 114 and the segment 114 is attached to the outer surface of the longitudinal member 152. 100 is different. In one embodiment, the segments 114 are curvilinear to provide a mounting surface having a curvature that is the same or approximately the same as the curvature of the outer surface of the longitudinal member 152. In substantially all other respects, some embodiments of the first portion 110 and the second portion 150 of the needle guard 200 are the same as providing the distal end covering of the needle 130 as described above. Works in a way. It is important to note that the arm 102 can be secured to the outer surface of the longitudinal member 152 at several more proximal locations. For example, the arm 102 can have a shorter length dimension, with the end of the arm 102 mounted at any position along the length of the longitudinal member 152. In some other embodiments, the arm 102 is eliminated altogether, at which time the proximal end 154 of the longitudinal member 152 is rigidly coupled to the base 118.

According to some other embodiments, the first portion 110 and the longitudinal member 152 of the needle guard 100 are integrally configured. In one embodiment, this unitary structure is achieved by subjecting the base 118 of the needle guard 100 to deep drawing to form the longitudinal member 152. In this method, the longitudinal member 152 extends from an opening 119 in the base 118 (co-extensive to, extending upward from the opening 119, extending in the same direction as the opening 119). Can be described as According to one embodiment, in the monolithic fabrication process, first, as shown in FIG. 6C, a metal strip 50 is formed, so that the metal strip 50 forms the base 118 of the needle guard 100. It has a designed area 52. In some embodiments, the metal strip 50 has a uniform thickness dimension, while in other embodiments, the metal strip 50 is expanded more than other sites, at least in the region 54. The region 54 has a thickness dimension, and the region 54 is a region to be subjected to the deep drawing method in order to form the longitudinal member 152. In some embodiments, prior to deep drawing longitudinal member 152, arm sections 101 and / or 102 are formed prior to deep drawing longitudinal member 152, eg, as shown in FIG. 6A. While in other embodiments, the arm sections 101 and / or 102 are formed after the longitudinal member 152 is formed. In some embodiments, the manufacturing method begins with a metal sheet that is uniform and has an increased thickness dimension, and subsequently the metal sheet is provided with arm sections 101 and / or 102. Flattened in areas 56 and 58 that are designed to be reside. The flattening step can be performed before or after the longitudinal member 152 is formed using the deep drawing method. Of one or more areas (56, 58 ) associated with the planarization process (in conjunction with, or thinned by subsequent to the planarization process) At least a portion of is cut to produce at least a portion of arm sections 101 and / or 102.

Referring to FIGS. 13-17, one or more features 155, 159, 160, 161, 163 and 164 can be formed to be longitudinal members 152 during the deep drawing process. The deep drawing method includes one or more dies having dimensions and sizes suitable for forming the one or more features 155, 159, 160, 161, 163, and 164. Done with. For example, in one embodiment, the truncated cone 160 and the small diameter end section 161 of the longitudinal member 152 are formed during the deep drawing process. The advantage of incorporating one or both of the features 160 and 161 into the longitudinal member 152 is that they enable the proximal section of the longitudinal member 152 to be automatically placed on the needle 130 during the assembly process. It is possible to be centered.

  According to another manufacturing method, prior to a piece of metal sheet being fragmented for the purpose of forming the first portion 110 of the needle guard 100, a plurality of longitudinal members 152 are first Deep drawing is performed entirely or at least partially from a single metal sheet.

  20-23 illustrate a needle guard assembly 300 according to another embodiment. The needle guard 300 is similar to that of the needle guard 100 described above, but is different from the needle guard 100 in that the arm segments 113 and 114 are deformed to have arcuate recesses 313 and 314. The recesses 313 and 314 are configured to at least partially coincide with the curvature of the outer surface of the longitudinal member 152. In one embodiment, one or both of the recesses 313 and 314 are configured as a semi-circle that allows the needle guard 300 to protect the distal end of the needle 130. When the second axial position is at the second axial position, it has a shape that matches the outer profile of the longitudinal member 152. That the distal sections 107 and 108 of the arms 101 and 102 are pushed outward so as not to cover the distal end of the needle 130 when improper forces act on one or both of the arms 101 and 102 For the purpose of blocking, the circumferential edges of the recesses 313 and 314 rest against the outer surface of the longitudinal member 152 (rest against, supported).

As shown in FIG. 21, a method of manufacturing a needle guard according to some embodiments disclosed herein and considered as a subject of the present invention begins with the flatness of the elastic material illustrated in FIG. Forming a first portion 310 of the needle guard 300 from a single piece by stamping, cutting or otherwise. After the first portion 310 is formed, the longitudinal member 152 is axially aligned with the opening 119 in the base 118 so that the through-passage 153 is axially aligned. Be placed. A fixture that extends through the opening 119 and extends through at least a portion of the through passage 153 may be used to support the longitudinal member 152. According to some other methods, the proximal end 154 of the longitudinal member 152 is provided with an outer small diameter segment 169 that extends through the opening 119 or otherwise into the opening 119. The purpose is to support, in whole or in part, the longitudinal member 152 in a posture that is perpendicular to the first portion 310, as shown in FIG. In one embodiment, a small diameter annular ring located in the vicinity of the proximal end 154 of the longitudinal member 152 bases the proximal end 154 of the longitudinal member 152 for the purpose of securing the longitudinal member 152 to the base 118. A means for snap-fitting into the opening 119 of 118 (snap fit, fitting and fixing using the elasticity of the material) is realized. In some other embodiments, a slit or slot is implemented in the base 118, which extends from the side edge of the base 118 to the opening 119. In this manner, the longitudinal member 152 is provided with a small diameter annular ring portion in the vicinity of the proximal end 154, and the small diameter annular ring portion is intended to attach the longitudinal member 152 to the base 118. Is fixed in the opening 119 after being laterally displaced (side-loaded, moved laterally in the slit or slot). When the longitudinal member 152 is properly supported on or properly mounted on the first portion 310, the first portion 310 can be bent in whole or in part, Thereby, several necessary arm parts and hinge parts are formed in whole or in part. At this point, the first portion 310 and the longitudinal member 152 can be loaded onto the needle 130 , at which time the first portion 310 is further bent (if necessary) and needled in the manner shown in FIG. 130.

  According to some embodiments, the first portion 310 and the longitudinal member 152 of the needle guard 300 are constructed integrally.

FIG. 24 shows a needle guard 350 according to another embodiment. The needle guard 350 is similar to that of the needle guard 300 described above, except that the end of the arm 102 is located slightly away from the recess 314 in the distal direction. Is different. In such an embodiment, when the recess 314 is pressed in continuous contact with the outer surface of the longitudinal member 152, when the needle guard 350 is in the second axial position on the needle 130 , The distal section 107 of the arm 101 is positioned so as to singularly cover the distal end 156 of the longitudinal member 152. The arms 101 and 102 of the needle guard 350 that are disclosed herein and considered the subject of the present invention are a plurality of features that differ in form, as illustrated in FIG. 24, the arm 102 has a recess 314 that abuts the outer surface of the longitudinal member 152, and the arm 101 has an elongate surface (axial surface, elongated) that abuts the outer surface of the longitudinal member 152. Surface) 113.

  According to some embodiments, the first portion of needle guard 350 and longitudinal member 152 shown in FIG.

  According to some embodiments, as shown in FIG. 25A, the longitudinal member 152 has an elastic structure 170 that has longitudinal sections 171 and 172 that overlap one another. The longitudinal sections 171 and 172 are separable from each other along the length of the longitudinal member 152 to temporarily form longitudinal slits or slots so that the longitudinal member 152 is laterally After displacement (side-loaded, after the longitudinal sections 171 and 172 are laterally displaced in a direction approaching each other), they are pressed against the needle 130. FIG. 25A shows a plan view of the longitudinal member 152. When the longitudinal member 152 is pressed against the needle shaft 131 side-loaded, the elastic structure 170 is wholly or partly restored to its initial shape, whereby the outer circumference of the needle shaft 131 is restored. Fully encircle. In one embodiment, the elastic structure 170 includes an elastomeric material that is in contact with the contact surfaces of the above-described overlapping longitudinal portions 171 and 172 that are in contact with each other. It has surface properties that promote the formation of seals along 171 and 172. In some other embodiments, the elastic structure 170 comprises a metal. In some embodiments, one or both of the overlapping contact surfaces of each of the longitudinal sections 171 and 172 induces a seal along the length of the longitudinal member 152. Surface treated with other materials or otherwise coated. In some other embodiments, the seal is formed between longitudinal longitudinal portions 171 and 172 that overlap each other using an ultrasonic welding method or other similar methods.

  In some other embodiments, as shown in FIGS. 25B-25D, the longitudinal member 152 has one or more slits 175a, 175b that are lateral to the longitudinal member 152. It is separable to facilitate pressing against the needle shaft 131 after side loading. Similar to some of the embodiments shown in FIG. 25A, the elongate member 152 can include an elastomeric material that contacts the contact surfaces of the slits 175a, 175b. The slits 175a and 175b have a property of promoting the formation of a seal portion between mating surfaces. In some other embodiments, one or both of the contact surfaces of each of the slits 175a, 175b is surface treated with a material that induces the formation of a seal along the length of the longitudinal member 152. Or otherwise coated. In some other embodiments, the seal is formed between the mating surfaces of the slits 175a, 175b using an ultrasonic welding method or other similar method.

  26-31 illustrate a needle guard assembly 400 according to another embodiment. The needle guard 400 is similar to that of the needle guard 100 described above, except that the arm segments 113 and 114 are formed to have a formed portion (pre-formed portion, predetermined shape). (Parts) 413 and 414 are different from the needle guard 100 in that they are deformed so that the molded parts 413 and 414 at least partially coincide with the curvature of the outer surface of the longitudinal member 152. It is configured. The proximal section of the longitudinal member 152 further includes a frustoconical portion 160 and a small diameter portion 161, similar to that shown in FIG. In one embodiment, the proximal edges 415 and 416 of the molded parts 413 and 414, respectively, when the needle guard 400 is in the second axial position to protect the distal end of the needle 130. One or both of them has a shape that matches the outer profile of the longitudinal member 152. In fact, as shown in FIG. 29, the distal sections 107 and 108 of arms 101 and 102 do not cover the distal end of needle 130 when an improper force is applied to one or both of arms 101 and 102. When the needle guard 400 is in the second axial position, the inner surfaces of the molded parts 413 and 414 lean against the outer surface of the longitudinal member 152 for the purpose of preventing the outer parts from being pushed outward. Rest against (rested against, supported) FIG. 30 is a perspective view showing the needle guard assembly 400 in the first axial position on the needle 130. FIG. 31 is a perspective view showing the needle guard assembly 400 in the second axial position on the needle 130.

  According to some embodiments, the first portion 410 and the longitudinal member 152 of the needle guard 400 are integrally configured.

  Similar to the embodiment described above in connection with FIG. 24, the needle guard 400 can be deformed such that the end of the arm 102 is located just distally away from the molded part 414. It is understood that there is. In such an embodiment, the molded part 414 is pressed in continuous contact with the outer surface of the longitudinal member 152, at which time the distal section 107 of the arm 101 causes the needle guard 400 to be on the needle 130. When in the second axial position, it is positioned to cover the distal end 156 of the longitudinal member 152 alone.

  FIG. 61 shows a needle guard assembly that is similar to that shown in FIG. 30, but with some different features (distinguising features). Is also present. The first different feature is the configuration of the needle. In the assembly of FIG. 30, the discrete profile change 132 is located in the distal end section of the needle in the vicinity of the distal tip 134. 61. In the assembly of FIG. 61, the limiting means is an elongate section whose diameter is larger than that of the peripheral portion (elongate). section having a length) having a proximal shoulder 402 of those located at the distal end of the needle. Another different feature is the configuration of the longitudinal member. In the embodiment of FIG. 30, the proximal section of the longitudinal member 152 has a small diameter portion 161 that is smaller in diameter than the periphery, which has a needle guard with a needle guard distal tip 134. The needle guard is configured to act on the profile changing portion 132 on the needle for the purpose of stopping the needle guard on the needle when the needle guard is actuated to cover the needle. In the embodiment of FIG. 61, the longitudinal member 408 has a diameter invariant structure that is uniform in diameter, and the diameter invariant structure has a tongue 409 that has a tongue 409. Is cut into the proximal end section of the longitudinal member 408. Once formed, the tongue 409 is crimped inward (crimped, corrugated, creased) so that at least a portion of the tongue 409 remains in the longitudinal member 408. Or bent (bent). The portion of the tongue 409 that remains in the longitudinal member 408 stops the needle guard on the needle when the needle guard is actuated to cover the distal tip 403 of the needle. It is configured to engage a shoulder 402 on the needle for the purpose of. In some embodiments, two or more tongues are provided.

  It is important to note that among the many guard guard features disclosed herein (disclosed forward and backward from this position) that relate to needle guard features. Many are interchangeable among the many embodiments disclosed herein and considered as the subject of the present invention. For example, each embodiment discloses features 113 and 114, other features 313 and 314, and other features 413 and 414, but these features 113, 114, 313, and 314 are disclosed. It is understood that 413, 414 can be incorporated into a single needle guard in accordance with the multiple inventions disclosed herein. Further, by way of example, the various elongate members 152 and elongate features disclosed herein are among the many embodiments disclosed herein and considered the subject of the present invention. Replace with each other.

  FIGS. 32-34 illustrate a needle guard assembly 500 that is similar to the needle guard assembly 300 described above, except that the distal end 502 of the longitudinal member 152 is A point having an orientation that is inclined with respect to the longitudinal axis of the longitudinal member 152 and the distal end of the arm 101 when the needle guard assembly 500 is in the second axial position as shown in FIG. The needle guard guard described above, with the section 107 having an angularly oriented orientation for the purpose of taking the above-described tilted orientation of the distal end 502 of the longitudinal member 152. Different from the assembly 300. The proximal section of the longitudinal member 152 further includes a frustoconical portion 160 and a small diameter portion 161, similar to that shown in FIG. The distal section 107 is preferably configured to exert a force at the distal end 502 of the longitudinal member 152 when the needle guard 500 is in the second axial position. A lip 504 located at the distal end of the distal section 107 is further oriented downward (oriented in a downward facing position), and the angled distal opening of the longitudinal member 152 The position of the arm 101 is positioned so that the compression force, i.e. the "pinch", acts on one or both of the arms 101 and 102. The purpose is to provide a mechanical stop mechanism that prevents the distal section 107 from separating from the distal end 502 of the longitudinal member 152.

  According to some embodiments, the first portion of the needle guard 500 and the longitudinal member 152 are integrally configured.

  The distal section 107 of the arm 101 separates from the distal end 502 of the longitudinal member 152 when a compressive force or “pinch” is applied to one or both of the arms 101 and 102. In an effort to prevent this, in various embodiments disclosed herein, a downward facing lip can be placed at the distal end of the distal section 107. In some embodiments, an indentation or kerf is provided on the distal end of the longitudinal member 152 to interlock with a lip disposed at the distal end of the distal section 107. Provided at the distal end 502.

  35-37 illustrate a needle guard 600 according to another embodiment. The needle guard 600 has a first portion 610 in which a longitudinal member 652 is incorporated. In one embodiment, the first portion 610 includes a first arm 601 and a second arm 602 that extend from opposite sides of the base 618, respectively. The first portion 610 is preferably manufactured from a single piece of elastic material, which includes a base 618, arms 601 and 602, and their distal section 607. And 608 to form. An opening (not shown) in the base 618 accommodates the proximal portion 136 of the needle 130 and the needle guard 600 is remote from the first axial position (shown in FIGS. 35 and 36). Having a size to accomplish guiding the needle guard 600 along the needle shaft as it transitions to a second axial position (shown in FIG. 37) to protect the distal end 134 . The arms 601 and 602 are hinged at the position of the base 618 and the needle guard 600 is in the first axial position when the distal end 134 of the needle 130 is not protected. It is comprised so that it may have the positional relationship contact | abutted with the outer surface of 130. FIG. The longitudinal member 652 has a proximal end 654 and a distal end 656 with a through passage 653 as an internal passage extending between the proximal end 654 and the distal end 656. Provided. Needle 130 has a proximal shaft portion 136 and a flared distal shaft portion 138 having an increasing diameter. In use, the longitudinal member 652 is positioned to be disposed within the first portion 610 and between the base 618 and the distal section 608. In one embodiment, the longitudinal member 652 is advanced so that the distal end 656 of the longitudinal member 652 can extend to or beyond the distal tip of the needle 130. In order to stop the needle guard 600 at the second axial position as shown in FIG. 37 in a state where the entire inner passage (through passage) 653 of the longitudinal member 652 has a large diameter, The opening is sized to engage the flared distal shaft portion 138. In another embodiment, the proximal end 654 of the longitudinal member 652 has a portion that acts to stop the needle guard 600 at the second axial position and has an inner diameter that is smaller than other portions. Is provided. In another embodiment, a sleeve or bushing is disposed at the proximal end 654 of the longitudinal member 652, and the sleeve or bushing is sufficient to act as a stop for making a stop in the second axial position. With an internal bore having a uniform diameter.

  As shown in FIG. 37, arms 601 and 602 are placed with the distal end 656 of the longitudinal member 652 positioned to cover the entire distal end 134 of the needle 130 (cover, cover, protect). For the purpose of covering the distal end 656 of the longitudinal member 652, they are spaced apart from the needle shaft and are pressed against each other inwardly by stored energy (stored energy). According to one embodiment, the distal section 608 of the arm 602 is hinged at position 620, the purpose of which is to exert a downward / proximal acting force on the distal end 656 of the longitudinal member 652. There is. In one embodiment, arms 601 and 602 are provided with protrusions 619 and 620 that interact with one or more internal features of the catheter hub, thereby A needle guard 600 is releasably secured within the catheter hub in a manner similarly described in connection with FIG.

  According to some embodiments, the first portion of the needle guard 600 and the longitudinal member 652 are integrally configured.

As described above, FIG. 38 is a side view of a safe intravenous catheter assembly 700 according to one embodiment, shown in a ready to use operative position. Catheter assembly 700 has a needle 130 that has a sharp distal tip 134, when an internal lumen is connected from proximal end 140 to the distal tip. It extends to 134. As described above, the profile changing section 132 on the needle shaft (the needle shaft) functions to stop the needle guard 100 at the second axial position. The proximal end of the needle 130 is attached to a needle hub 704 having a plurality of proximal protrusions 706, the needle hub 704 having a plurality of protrusions for attaching male luer fittings. 706. The proximal end 140 of the needle 130 is disposed within the flashback chamber 708 of the needle hub 704. As described above, the protrusions 117 and 116 engage with one or more features 703 disposed on the inner wall of the catheter hub 702 so that the needle guard 100 is removably secured within the catheter hub 702. Is done. The proximal end of the catheter hub 702 is operatively engaged with the distal end of the needle hub 704. The tubular catheter 710 is distal from the distal end of the catheter hub 702 so that the needle tip (distal tip) 134 is exposed to puncture the blood vessel and introduce the tubular catheter 710 into the blood vessel. Extending in a direction (distally, away from the operator) and in a coaxial relationship with the needle 130, the end of the tubular catheter 710 is proximal to the needle tip 134 (proximal) Near). In use, when the tubular catheter 710 is properly introduced into the patient's blood vessel, the needle hub 704 is pulled proximally, thereby causing the needle tip 134 to be retracted from the patient. ) Stored in the needle guard 100. When the needle 130 is retracted, the needle guard 100 is fixed in the needle hub (catheter hub) 702 by the outward force applied by the convex portions 117 and 116. The combination of the position of the profile change portion 132 on the needle 130 and the dimensional characteristics of the needle guard 100 results in the distal state with the profile change portion 132 stopped on the needle guard 100. The tip 134 is fully contained within the longitudinal member 152. As the distal tip 134 enters the distal end 156 of the longitudinal member 152, the distal arm segments (distal sections) 107 and 108 disengage from the needle shaft and the energy stored in the arms 101 and 102 is stored. Thus, the distal sections 107 and 108 are pressed inward, respectively, such that the distal end 156 of the longitudinal member 152 is covered. At the same time, the protrusions 116 and 117 are spaced from the catheter hub 702, thereby allowing the needle guard 100 and needle 130 to be completely removed from the catheter hub 702.

39 and 40 show an intravenous catheter assembly 800 according to another embodiment. The catheter assembly 800 is similar to that of the catheter assembly 700 described above. The difference is in the manner in which the needle guard 100 is releasably secured within the catheter hub 802 (manner, manner, type). In the catheter assembly 800, instead of using the protrusions 117 and 116 formed on the arms 101 and 102, the elastic tab 810 is disposed at the same position as the base of the needle guard 100 or a position near it. And 811 project outwardly, thereby engaging one or more features 803 of the inner wall of the catheter hub 802. The outer engagement surfaces of each of the elastic tabs 810 and 811 are preferably arcuate to match the curvature of the inner wall of the catheter hub 802. The one or more features 803 may have a recess, undercut, cavity, groove, protrusion, etc. that is configured to be annular or discretely around the inner wall. . The elastic tabs 810 and 811 are configured to exert an outward force, the purpose of which is when the catheter assembly 800 is in the ready position or while the needle 130 is retracted into the needle guard 100. The engaging surfaces (the respective outer engaging surfaces of the elastic tabs 810 and 811) are to engage one or more features 803. The engaging force of the elastic tabs 810 and 811 is such that when the needle 130 engages the needle guard stopper, one or more features 803 (FIG. 40)) small enough that it is possible to leave.

  FIG. 41 shows the needle guard assembly 900 in a protected position on the Huber needle, which is near the distal end of the needle 190. It is characterized by having a change in axis, that is, a bend. Needle guard assembly 900 is similar in many respects to some of the previously described embodiments, but when needle 190 is retracted into a protected position within longitudinal member 952. An internal passage that extends through the longitudinal member 952 such that the distal portion 958 of the longitudinal member 952 can have a cant and cant around the centerline change. Is configured. In one embodiment, the proximal end section 960 of the longitudinal member 952 is a segment with a small inner diameter that is suitable for stopping the needle guard at the centerline change. The thing which has thickness is provided. In some other embodiments, a sleeve having a sufficient length dimension and a small inner diameter is attached or otherwise connected to the proximal end of the longitudinal member 952. In some other embodiments, the profile changing portion or the expanding portion is arranged at a position closer to the center line changing portion in order to function as a stopper for performing the stop.

  42A-42D illustrate an intravenous catheter assembly 210 according to some other embodiments. The intravenous catheter assembly 210 differs from the intravenous catheter assembly 700 of FIG. 38 in that the distal sections 107, 108 of the resilient arms 101, 102 are in the ready position as shown in FIG. 42A. Is not biased against the needle shaft 131, but instead is biased and biased against the longitudinal member 212. . As shown in FIG. 42D, in one embodiment, the longitudinal member 212 has a distal section 214 and a smaller diameter proximal section 216. The outer diameter of the proximal section 216 is small enough to be placed in the opening 119 in the base 118, with at least the distal section 214 being at least the proximal section 216. The outer diameter of the adjacent portion is larger than the opening 119. The outer diameter of at least a portion of the proximal section 216 is such that the base 118 of the spring clip 220 extends axially along the length of the proximal section 216, as will be described in detail later. It is large enough to be slidable.

As shown in FIGS. 42A and 42B, in the ready position, the base 118 of the spring clip 220 is in contact with (on) the proximal section 216 of the longitudinal member 212 that is smaller in diameter than the periphery. And a distance D1 provided to allow the base 118 to travel axially along a proximal section 216 that is smaller in diameter than the periphery at a position proximal to the distal section 214. Indwelling with In one embodiment, when in the ready position, the axial position of the spring clip 220 on the longitudinal member 212 causes the lip segments 111, 112 to engage within the one or more recesses 217, 218. And is releasably fixed so that the recesses 217, 218 are located near the distal end of the longitudinal member 212. In some other embodiments, other co-operable features that are capable of working in concert with other are in the ready position In order to engage the lip segments 111 and 112 to assist in determining the range of movement of the axial position and rotational position of the spring clip 220 on the longitudinal member 212 (delimit). At a location near the distal end of the longitudinal member 212. In some embodiments, the distal sections 107, 108 of the resilient arms 101, 102 are properly oriented with respect to the distal end of the longitudinal member 212. In addition, the recesses 217, 218 obstruct or limit the ability of the spring clip 220 to rotate on the longitudinal member 212. In some embodiments, only one recess (or one other feature that limits movement) determines the range of movement of the position of the spring clip 220 on the longitudinal member 212. (Delimit) is provided at a location near the distal end of the longitudinal member 212.

In one embodiment, as shown in FIG. 52, the cooperating feature on the elongate member includes an annular ring 213 that includes lip segments 111, 112. Recesses 217 and 218 on which the upper portions (upper portions) are placed. In one embodiment, as shown in FIG. 52, the plane traversed by the annular ring 213 is inclined with respect to the longitudinal axis of the longitudinal member. In some other embodiments, the longitudinal member has a distal end 223 that is substantially perpendicular to the longitudinal axis of the longitudinal member. is there. In such an embodiment, as shown in FIG. 53, the plane traversed by the annular ring 224 may also be arranged to be perpendicular to the longitudinal axis of the longitudinal member. Is possible. In each of the embodiments of FIGS. 52 and 53, each annular ring is inclined with respect to the longitudinal axis on the surface of the longitudinal member to engage each of the lip segments 111 and 112. A first section disposed and a second section disposed at a right angle to the major axis (raised, first and first) Two sections are raised from the surface of the longitudinal member) and are separated from each other (discrete, the first and second sections are spatially discrete from each other) . In some other embodiments not shown in any drawing, a plurality of raised features on the surface of the longitudinal member when the spring clip 220 is in the ready position. A plurality of pockets (pockets, holes, holes) for receiving the lip segments 111, 112 to impede the spring clip 220 moving axially and rotationally on the longitudinal member. Forming indentations and receptacles).

As described above, the spring clip 220 is releasable by the protrusions 116 and 117 engaging one or more features 703 located on the inner wall of the catheter hub 702. When possible, it is secured within the catheter hub 702. The proximal end of the catheter hub 702 is operably engaged with the distal end of the needle hub 704. The tubular catheter 710 is distal from the distal end of the catheter hub 702 so that the needle tip (distal tip) 134 is exposed to puncture the blood vessel and insert the tubular catheter 710 into the blood vessel. Extending in a direction (distally, away from the operator) and in a coaxial relationship with the needle 130, the end of the tubular catheter 710 is proximal to the needle tip 134 (proximal) Near). In use, when the tubular catheter 710 is properly inserted into the patient's blood vessel, the needle hub 704 is pulled proximally, thereby retracting the needle tip 134 from the patient. Stored in. When the needle 130 is withdrawn, the outward force exerted by the projections 117 and 116 secures the needle guard within the catheter hub 702, while at the same time the spring clip 220 engages the recesses 217 and 218. It is secured against axial movement on the longitudinal member 212 by inward forces exerted by the lip segments 111 and 112 placed in the interior of each. With the profile change portion 132 of the needle 130 stopped in the longitudinal member 212, further pulling of the needle hub 704 in the proximal direction causes the base 118 of the spring clip 220 to be pulled. , Distally over the small diameter proximal section 216 of the longitudinal member 212, the base 118 is located at the proximal end of the distal section 214 of the longitudinal member 212 / shoulder / overhang (ledge, It is advanced until it is pressed against and rested against ledges, ledges, ridges) 219 and the like. (In some other embodiments, the shoulders 219 and the like are annular rings that are radially expanded from the outer surface of the distal section 214 of the longitudinal member 212 as shown in FIG. Having a configuration, thereby restricting the base 118 of the spring clip 220 from moving axially over the longitudinal member 212 (limit defining a movement limit). The force M exerted by pulling causes the lip segments 111 and 112 to slide out of the respective recesses 217 and 218 and the distal arm segment (distal section) 107 of the spring clip arms 101 and 102. And 108 are advanced to advance beyond the distal end 221 of the longitudinal member 212. Having a sufficient size to. In one embodiment, the base 118 advances distally to the maximum extent on the proximal section 216 of the longitudinal member 212 so that the distal tip 134 of the needle 130 enters the distal end 221 of the longitudinal member 212. Occurs substantially simultaneously. At the same time, the protrusions 116 and 117 are disengaged from the catheter hub 702, thereby allowing the needle guard to be completely separated from the catheter hub 702. FIG. 42C shows the assembly with the distal tip 134 of the needle 130 secured safely (safely, non-hazardous, protected) within the needle guard longitudinal member 212. ing.

In one embodiment, as shown in FIGS. 43A-43D, the force M acting in the proximal direction is applied to the needle hub 704 with the profile change 132 of the needle 130 stopped in the longitudinal member 212. The spring clip 220 is designed to extend when acted upon. This onset of elongation occurs so that the base 118 of the spring clip 220 occurs at the same time or earlier than when the shoulder / bump 219 of the longitudinal member 212 engages. It is possible. As shown in FIG. 43B, the extension described above results in resistance between the protrusions 116 and 117 of the spring clip 220 and one or more features 703 disposed on the inner wall of the catheter hub 702. ,Occur. The initial extension is indicated by note L1 in FIG. 43B. In the embodiment of FIG. 43, the spring clip 220 is axially advanced over the small diameter proximal section 216 of the longitudinal member 212 when the base 118 of the spring clip 220 engages the shoulder / ridge 219. The length to do is not sufficient to allow the lip segments 111 and 112 to advance beyond the distal end 221 of the longitudinal member 212. Instead, the combination of axial advancement of the base 118 over the proximal end of the longitudinal member 212 and extension of the spring clip 220 (shown in FIG. The segments 111, 112 are allowed to advance beyond the distal end 221 of the longitudinal member 212. During the action process, the spring clip 220 is stretched so that when the spring clip 220 is acted to cover (close, protect) the distal end 221 of the longitudinal member 212, the distal end of the elastic arm 101 is disengaged. As the distal segment (distal section) 107 attempts to have a length that is shorter than L2 by resiliently, it exerts another downward force on the distal end 221 of the longitudinal member 212. Such closure causes the distal tip 134 of the needle 130 to be tightly confined within the longitudinal member 212.

  In another embodiment, as shown in FIGS. 44A-44D, the longitudinal member 230 does not include a proximal section 216 that is smaller in diameter than the periphery. Instead, in the ready position of the base 118, the spring clip 220 is pressed against and placed on the inside surface of the base 118 or is the same as the proximal end of the longitudinal member 230. It is fixed at the position or near position. In accordance with this embodiment, the selection of the dimensional and material properties of the spring clip 220, along with the selection of the force acting between the projections 116 and 117 and the feature 703 on the inner wall of the catheter hub 702, can When the clip 220 itself is stretched, the lip segments 111, 112 extend beyond the distal end 234 of the longitudinal member 230 because the distal tip 134 of the needle is securely received within the longitudinal member 230. It is done so that advancing is done as a result. 44A-44D illustrate the base 118 of the spring clip 220, which base 118 has the longitudinal member 230 with the proximal portion 232 of the longitudinal member 230 extending through the opening 119 in the base 118. Is attached. 45A-45D illustrate another embodiment in which the longitudinal member 230 (having a shorter length than the previous one) is located distally relative to the base 118 in its entirety. (Positioned entirely distal to the base 118). In some such embodiments, the end 236 of the longitudinal member 230 is attached to the base 118 or simply pressed against and rests on the end 236. It is possible.

  In some embodiments, the base 118 of the spring clip 220 moves along the proximal section of the longitudinal member to actuate the needle guard assembly, as described above in connection with FIGS. However, in those embodiments, other configurations for the longitudinal members are contemplated. For example, in the embodiment of FIG. 42, the axial position of the spring clip 220 on the longitudinal member 212 is a recess located near the lip segments 111, 112 of the spring clip 220 and the distal end of the longitudinal member 212. 217 and 218 are held in the ready position by interaction. In another embodiment, the spring clip 220 is wholly or at least partially due to interaction between the base 118 of the spring clip 220 and the proximal section of the longitudinal member 212. , Held in the preparation position. In some other embodiments, the spring clip 220 is generally held in the preparatory position by interaction of the base 118 and the proximal section of the longitudinal member 212 to implement them. In embodiments, recesses 217, 218 or other retaining features need not be used on distal section 214 of the longitudinal member.

  FIG. 46 illustrates an embodiment in which one or more ridges 238 are arranged circumferentially around the small diameter proximal section 216 of the longitudinal member 212. The one or more ridges 238 move the base 118 over the proximal section 216 until sufficient force is applied to overcome the resistance between the circumferential region of the opening 119 and the one or more ridges 238. To prevent axial advancement, the spring clip 220 has a size that acts in conjunction with an opening 119 in the base 118. In one embodiment, when a force acts on a circumscribed portion of the base 118 that circumscribes the opening 119 (circumscribe, which contacts the outer periphery of the opening 119) by the one or more raised portions 238, the circumscribed portion is deformed. This facilitates the advancement of the opening 119 beyond the one or more ridges 238 when the longitudinal member is pulled proximally. In some embodiments, one or more ridges 238 that are discrete from one another are replaced by a single raised annular ring.

  In some other embodiments, the spring clip 220 is at least partially retained on the longitudinal member in the ready position by use of an annular recess 254 located on the proximal section of the longitudinal member. FIG. 47 shows a longitudinal member 250 having a distal section 251 and a smaller diameter proximal section 252. The small diameter proximal section 252 generally has a diameter that is greater than the diameter of the opening 119 in the base 118 of the spring clip 220. An annular recess 254 is disposed within the small diameter proximal section 252, and the annular recess 254 is sized to accommodate a portion of the base 118 of the spring clip 220 that contacts the outer periphery of the opening 119. The portion of the base 118 that fully or partially touches the outer periphery of the opening 119 has a diameter of the opening 119 when the spring clip 220 is initially mounted on the proximal section 252 of the longitudinal member 250. It has sufficient elasticity to be able to expand. The portion of the base 118 that contacts the outer periphery of the opening 119 also moves so that the diameter of the opening 119 increases and the base 118 retracts from the annular recess 254 when a sufficient force is applied to the base 118. It also has sufficient elasticity to allow the base 118 to move distally along the small diameter proximal section 252 of the longitudinal member 250. The advantage of this configuration is that the press fit between the base 118 and the proximal section 252 of the spring clip 220 when the spring clip 220 is acted upon to close the distal end 255 of the longitudinal member 250 (see FIG. compression fit) prevents or minimizes the amount of spring clip 220 axially and radially displaced on the longitudinal member 250.

  FIG. 48 shows a longitudinal member 260, which is common to the longitudinal member 250 of FIG. To do. The difference between the longitudinal member 260 and the longitudinal member 250 is that the longitudinal member 260 has a generally uniform cross-section along its length.

FIG. 49A shows a longitudinal member 270 according to another embodiment. The longitudinal member 270 has a distal section 271 and a proximal section 272. Proximal section 272 has a proximal segment 273 that is smaller in diameter than the periphery and a frustoconical segment 274 that has a smaller diameter at the proximal end 275 of segment 274. The dimensions vary from a large diameter dimension at the distal end 276 of that segment 274. In one embodiment, the diameter at the distal end 276 is at least equal to the diameter of the distal section 271 of the longitudinal member 270 (at least equal to the diameter of the distal section 271 of the longitudinal member 270). Good). As shown in FIG. 49B, in one embodiment, the spring clip 220 is assembled to the longitudinal member 270 such that the small diameter proximal segment 273 extends through the opening 119 in the base 118. In some embodiments, the opening 119 has a diameter that is only slightly larger than the outer diameter of the proximal segment 273. In some other embodiments, the diameter of the opening 119 and the outer diameter of the proximal segment 273 is a frictional force between the periphery of the opening 119 and the outer surface of the proximal segment 273. The frictional fit is selected so that the friction fit establishes a sliding relationship between the two parts. In some other embodiments, the diameter of the opening 119 has a smaller diameter than the outer diameter of the proximal segment 273 before the spring clip 220 is assembled to the longitudinal member 270. In a manner similar to that described above, in such an embodiment, at least a portion of the base 118 that touches the outer periphery of the opening 119 completely or partially can be deformed (plastically and / or (Or elastically), thereby allowing the diameter of the opening 119 to conform to, conform to, and follow the outer diameter of the proximal segment 273. The material characteristics and dimensional characteristics of the base 118 and the proximal segment 273 are such that when a minimum axial force (minimum axial force) acts on the two parts, the two parts slide relative to each other. It is like that.

  In one embodiment, the base 118 of the spring clip 220 is placed in the position of the proximal end 275 of the frustoconical segment 274 in the ready position, while in some other embodiments, the base 118. Is placed on the proximal segment 273 as shown in FIG. 49C. In use, when the catheter 710 is properly inserted into the patient's vessel, the needle hub 704 removes the distal tip 134 for the needle from the patient and into the needle guard. To the proximal direction. As the needle is withdrawn, the needle guard is secured within the catheter hub 702 by the outward force exerted by the protrusions 116 and 117, while at the same time the spring clip 220 is as described above. The cooperation between the base 118 and the proximal section 272 of the longitudinal member 270 holds the axial position on the longitudinal member 270 from changing. In the state where the profile changing portion 132 of the needle 130 is stopped in the longitudinal member 270, if the force M acting in the proximal direction further acts on the needle hub 704, the spring clip 220 is caused as a result. The base 118 can be advanced distally to hit the frustoconical segment 274 because of the property that at least a portion of the base 118 deforms as described above. In one embodiment, the advancement of the base 118 in the distal direction continues until the base 118 reaches the distal end 276 of the frustoconical segment 274 or the proximal end of the distal section 271. The base 118 slightly precedes reaching the most distal position on the proximal section 272 of the longitudinal member 270, or at the same time, the distal tip 134 of the needle 130 is fully fully The lip segments 111 and 112 of the spring clip 220 are advanced beyond the distal end 278 of the longitudinal member 270, as shown in FIG. The distal tip 134 is secured within the longitudinal member 270 safely (in a safe and non-hazardous manner). The advantage of this configuration is that when the spring clip 220 is actuated to occlude the distal end 278 of the longitudinal member 270, the base 118 of the spring clip 220 and the distal end 276 of the frustoconical segment 274. A compression fit between the spring clip 220 is prevented or minimized in the axial and radial displacement of the spring clip 220 on the longitudinal member 270.

  FIG. 50 shows a longitudinal member 280 having a configuration in common with the longitudinal member 270. The difference is that a stopper 284 is added that is located at the same position as or near the proximal end of the distal section 271. The stopper 284 can have the form of an annular ring as shown in FIG. 50 or can have one or more raised segments disposed about the outer periphery of the longitudinal member 280. The diameter of the stopper 284 is large enough to actively prevent the base 118 of the spring clip 220 from advancing beyond the stopper 284.

  FIG. 51 shows a longitudinal member 290 that is common to the longitudinal member 270 except that the entire proximal section 272 has a frustoconical shape.

  According to some embodiments, as shown in FIG. 55A, the proximal section of the longitudinal member comprises one or more radial projections 295 that are longitudinal. In some such embodiments (in FIG. 55A, only one protrusion is shown), the opening 119 in the base 118 of the spring clip 220 has a corresponding shape as shown in FIG. 55B. An indentation or notch 296 that accommodates one or more radial protrusions 295. Many configurations can be employed. Keying the proximal section of the longitudinal member to the opening 119 in the base 118 of the spring clip 220 provides several advantages. First, during operation, the key coupling prevents the spring clip 220 from rotating over the longitudinal member as the spring clip 220 is axially advanced over the longitudinal member. Second, it becomes easy to properly determine the orientation of the spring clip on the longitudinal member in the manufacturing / assembly process. Third, it is possible to prevent the spring clip and the longitudinal member from being combined in an inappropriate pair in the assembly process. According to one embodiment, the length of the one or more radial protrusions 295 is selected such that the spring clip 220 is always prevented from rotating on the longitudinal member. That is, it is selected so that the rotation is prevented both when the needle guard is in the ready state and in the working state. In some other embodiments, the length of the one or more radial protrusions 295 is allowed for the spring clip 220 to rotate on the longitudinal member when the needle guard reaches the working state. A shorter length (shorter than the previous embodiment) to prevent the needle guard from being in the ready state or transitioning from the ready state to the working state. ) Is selected.

  56A and 56B show another key connection scheme, where FIG. 56A shows a longitudinal member with a flat side 296 and FIG. 56B shows an opening. A base 118 of a spring clip 220 having 119 is shown, the opening 119 conforming to the cross-sectional shape of the longitudinal member.

As described above, according to some embodiments, at least a portion of the base 118 of the spring clip 220 deforms when actuated by the distal section of the longitudinal member, thereby opening the opening. 119 is enlarged in the diameter direction. In some other embodiments, as shown in FIG. 57A, the base 118 has a plurality of deformable projections 298 aligned along the perimeter of the opening 119. The material properties and dimensional properties of the protrusions 298 were selected in the proximal section of the longitudinal member as the longitudinal member was pulled in the proximal direction (pulled upon). When a portion actuates the plurality of protrusions 298, the plurality of protrusions 298 are selected to bend and / or compress. For example, in the embodiment of FIG. 49, the base 118 of FIG. 57A can be used such that a similar effect is achieved. At the starting point, the size of the plurality of protrusions 298 is such that the base 118 slides along the proximal section 272 of the longitudinal member 270 until the base 118 reaches the proximal end 275 of the frustoconical segment 274. Is a size that one circle connecting the vertices of the plurality of protrusions 298 has an allowable diameter. Although not essential, it is desirable that three or more protrusions 298 evenly spaced around the perimeter of the opening 119 are connected to the base 118 during the device assembly process and during its use. Provided to assist in maintaining an orthogonal relationship with the long axis of the longitudinal member 270. That is, the state in which the base is aligned in the axial direction with respect to the longitudinal member is favorably maintained. During during activation, when the aforementioned proximal force M is applied to the needle hub 704, the proximal force M causes the base 118 of the spring clip 220 to act on the frustoconical segment 274. It is pushed in the distal direction. The applied force deforms the plurality of protrusions 298 that are deformable (ie, by compression and / or bending), thereby causing the base 118 to be distal end 276 of the frustoconical segment 274. Until the base 118 is stopped there, the base 118 can travel along the outer surface of the frustoconical segment 274. The needle guard assembly otherwise operates in the same manner as the needle guard assembly described above in connection with FIGS. 49A-49D.

  In some other embodiments, the opening 119 has the ability to expand, and in some cases, the opening 119 has the ability to contract. 57B, this is accomplished by the addition of one or more slits 299 formed by cutting into the base 118. As shown in FIG. For example, in addition to the suitability of the openings 119 and base 118 for use in the embodiment of FIGS. 49A-49D, the base 118 or opening 119 shown in FIGS. 57A and 57B. Are particularly useful in connection with some of the longitudinal members shown in FIGS. 46-48 because the opening 119 has a diameter due to the expansion and / or contraction of the opening 119. It is highly capable of adapting to variations (longitudinal member diameter variation, longitudinal member diameter variation).

  58A-58C show an elongate member 301 according to another embodiment. For ease of explanation, the drawings show the longitudinal member 301 with the spring clip omitted. FIG. 58A is a perspective view showing the longitudinal member 301 alone. FIG. 58B shows the longitudinal member 301 mounted on the needle shaft 131 in the ready position. FIG. 58C shows the longitudinal member 301 after the needle guard assembly has been acted on the needle shaft 131 with the distal tip 134 of the needle 130 fully seated within the longitudinal member 301. Shown in state. A feature of the longitudinal member 301 that is different from the plurality of longitudinal members already disclosed in this document is that the sealing member 302 installed at the same position as the distal end of the longitudinal member 301 or in the vicinity thereof. It is a point that has been added. The seal member 302 advantageously seals the distal tip 134 of the needle 130 within the longitudinal member 301 after the distal tip 134 of the needle 130 is fully retracted within the longitudinal member 301 (seal, Seal). By employing such a configuration, after the distal tip 134 of the needle 130 is inserted into the elongate member 301, the body fluid that may flow out of the distal tip 134 of the needle 130 is contained. Is promoted.

The sealing member 302 can have any of a variety of types. In one embodiment, the seal member 302, elastic insert has a 303 (Elastomeric insert, the insert made of rubber-like elastic body), the elastic insert 303, in those figures (the figures), the longitudinal members 301 It is installed in the distal end. In some embodiments, the resilient insert 303 has an outer diameter that is greater than the inner diameter of the distal end of the longitudinal member 301. In some embodiments, the elastic insert 303 is held in the longitudinal member 301 by a compressive force generated by the elastic insert 303 pressing the inner wall of the longitudinal member 301. In some embodiments, an adhesive or heat bonding is used in place of, or in combination with, the attachment methods described above. In some embodiments, the seal member 302 has an elastic cap ( elastomeric cap) 305, which is a longitudinal member 301 as shown in FIG. It is spread on the outer surface so as to cover the outer surface and is detained on the outer surface. In some embodiments, an adhesive or heat bonding is used in place of, or in combination with, the extension attachment methods described above.

In some embodiments of FIGS. 58 and 59, a slit crossing the front of the seal member 302 (face) in the diameter direction (Slit, tears, holes, gaps) 304, so that the needle 130 penetrates the sealing member 302 To help you pass through. It is possible to use several features that are different from a self-closing slit. As shown in FIGS. 58B and 58C, when the distal tip 134 of the needle 130 occupies a position within the longitudinal member 301, the slit 304 closes. In some embodiments, as shown in FIGS. 58 and 59, the distal end of the longitudinal member 301 has a large diameter distal section 306 that is larger in diameter than the periphery, and the large diameter distal section 306 Accommodates the seal member 302 or otherwise facilitates attachment of the seal member 302 to the longitudinal member 301. In the embodiment of FIG. 59, the large diameter distal section 306 provides a proximal proximal annular shoulder 307 on which the proximal portion of the elastic cap 305 rests. It is possible to rest upon. By surrounding the elastic cap 305 over the distal section 306, the elastic cap 305 is more securely fixed on the longitudinal member 301.

  In the foregoing description of FIGS. 42-59, a needle guard assembly having a spring clip portion and a longitudinal member portion has been described within the scope of an intravenous catheter application. However, it is understood that the needle guard assembly of FIGS. 42-59 may be combined with a number of other types of needle products, Including but not limited to syringes, guidewire introducers, blood collection devices and the like. In some cases, the element that distinguishes these other types of needle-related products from intravenous catheters and distinguishes them from each other is how the needle guard assembly is advanced along the needle shaft. . For example, in some cases, the mechanical thrust for advancing the needle guard assembly over the needle shaft is directly applied by the user's hand, spring, compressed air or other propulsion means. Given to. In the foregoing description of FIGS. 42-59, the spring clip has been disclosed as having first and second resilient arms 101 and 102. FIG. However, it is important to note that various configurations of clips are employed, such as one-armed clips such as the arms shown in FIGS. 18, 19 and 24. Is possible. Furthermore, as in the embodiment of FIGS. 60A and 60B described below, the arm of the clip occludes itself to cover the distal end of the longitudinal member. To do so, it depends on other means and can depend on something different from its own elasticity. Another important thing to note is that many of the features associated with several spring clips and several longitudinal members (discussed above and below) disclosed in this document are: A wide range of needle guard assemblies and safety needle products can be interchanged with each other and / or combined to properly formulate safety needle products.

60A-60C illustrate a guidewire introducer 360 according to another embodiment. The guidewire introducer 360 has a needle 361 whose proximal end is secured within a needle hub 364. The needle 361 has a profile changing portion 362 on the distal end of the needle 361 at a position near the distal tip 363 of the needle 361. In the ready position, the needle guard assembly is left in the housing 367, which housing 367 is attached to the needle hub 364 at its proximal end. The needle guard assembly has a first part 370 and a second part 380. The first part 370 has a central section that at least partially circumscribes the outer periphery of the shaft of the needle 361. A second part 380 is placed in the central section, and the second part 380 is in the form of a cylindrical elongate member that completely encloses the shaft of the needle 361. Have In one embodiment, the proximal end of the longitudinal member 380 (second part) has a raised annular ring 381 that is raised from the surroundings, the raised annular ring 381 securing the longitudinal member 380 to the first part 370. Therefore, the first component 370 is fitted in an annular recess 373 in the base end (base). In one embodiment, the first part 370 has a molded plastic structure that has an arm 371 that is a base to which the arm 371 is hinged. Extending distally from the end. The arm 371 has a distal section 372 that leans against the shaft of the needle 361 when the needle guard assembly is in the ready position (see FIG. 60A); It is also configured to cover (cover, protect) the distal end of the longitudinal member 380 when the needle guard assembly is activated (see FIG. 60B). When in the ready position, guidewire introducer 360 is coiled spring 374 within housing 367 by a retaining means (not shown in the drawings). Or the coiled spring 374 or other elastic structure is released from the retaining means, which resists the force exerted by the other elastic structure. Then, it arrange | positions so that the said guard may be extruded to a distal direction. In the example of FIGS. 60A and 60B, the proximal end of spring 374 is attached to the proximal end of housing 367, and at least a portion of the distal end of spring 374 is molded as described above. A part of the plastic structure 370 (first component), which contacts at least one of the arms 371 having at least a part thereof. In use, when the needle guard is released from the retaining means, the spring 374 in a compressed state extends distally, whereby the needle guard Are propelled forward until the distal tip 363 of the needle 361 is fully seated within the longitudinal member 380. In addition to propelling the needle guard forward along the needle 361, the spring 374 further acts to apply a compressive force against the arm 371, thereby causing the distal section 372 of the arm 371 to move. Arm 371 is biased radially inward to occlude the distal end of longitudinal member 380.

  In some other embodiments, the first and second parts 370 and 380 of the needle guard are spring clips and longitudinal members similar to the spring clips and longitudinal members described above and the spring clips and longitudinal members described below. It has a member. In some embodiments of this type and in another, the spring 374 is positioned below the base 118 of the spring clip (beneath, directly below, on the bottom, proximal) However, it is possible to install the spring clip in a position for propelling it distally along the needle shaft.

62A-62D illustrate a needle guard assembly similar to the plurality of needle guard assemblies shown, for example, in FIGS. 6-10, 20-23, and 26-29. ing. 62A and 62B are a plan view and a side view of the needle guard, respectively, and the needle guard is in a state before folding the elastic arms 422 and 423 to form the spring clip 421 . 62A and 62B, the longitudinal member 430 is shown as extending upward from the base 118. As described above, the longitudinal member 430 has a portion that is separate from the first portion 420 so that the longitudinal member 430 is attached to the base 118 or the base 118 and the resilient arms 422, 423. It can simply be placed between the distal end of The longitudinal member 430 can also be formed from the first portion 420 by the drawing process described above. Similar to the guidewire introducer 360 described above, in some cases it may be desirable that the needle guard occupies a working position so that the needle guard is propelled distally along the needle shaft. Is given. In some embodiments shown in FIGS. 60A-60C, such propulsion is effected by a coiled spring 374 that is separate from the clip itself. . In some of the needle guard assemblies of FIGS. 62A-62D, the spring means are not formed separately from the clip, but instead are the same stock material as the clip itself ( stock material, blank material before main processing, raw material before main processing). That is, the spring means is formed integrally with the clip. As shown in FIGS. 62A and 62B, a plurality of long protrusions 440 extend from the side of the base 118 and are longitudinally aligned with each other (longitudinally aligned). A hole 441 is provided. Similar to the elastic arms 422 and 423, the protruding portion 440 has elasticity, and as a result, the protruding portion 440 is folded along a plurality of lines 443 as shown in FIGS. 62C and 62D. A spring 442 is formed. An opening 446 in the base 445 of the protrusion 440 allows the plurality of slots 441 to be positioned so that the needle guard assembly can be mounted on the needle shaft when the protrusion 440 is folded. (Aligned with, aligned with a plurality of slots 441, aligned with a plurality of slots 441). For example, in the guide wire introducer as shown in FIG. 60, the base 445 of the protrusion 440 can be attached to the base of the housing 367. When the needle guard is in the ready position, the formed spring 442 is in compression within the housing 367 and acts against the base 118, so that the spring clip 421 and the longitudinal member 430 A needle guard having a radiating force is urged distally along the needle shaft toward the distal tip of the needle. When the needle guard is released from the housing 367, as shown in FIGS. 62C and 62D, a spring 442 will place the guard distally and the distal tip of the needle fully within the longitudinal member 430. Extrude until done.

  In some other embodiments, an elongate protrusion 440 simply allows the needle guard to advance distally over the needle shaft. Acts as a tether to limit (advance limit), tether, string to hold the needle guard, restraint. However, in some other embodiments, the protrusion (protrusion 440) is used to form a spring 442 and the needle guard is advanced distally over the needle shaft. It is also used to act as a limiting means that limits what is done (limit, defines a forward limit).

  63A-63D illustrate a needle guard 510 according to another embodiment. The needle guard 510 is manufactured from a substantially flat material that is elastic and is similar or identical to that shown in FIGS. 6A, 6B, 20, 26 and 32. It can be manufactured to have a certain structure. For convenience of explanation, the same reference numerals as those used in FIG. 6A are used for the same components in FIGS. 63A to 63D. It is important to note that the construction (the construction, the configuration of the embodiment shown in FIGS. 63A-63D) is not limited in any way to FIGS. 6A, 6B, 20, 26, 32 and 42. It is that it is not limited to what is shown to.

  As shown in FIG. 63A, in an as-cut or stamped configuration, the needle guard 510 includes first and second biasing members 513 having a longitudinal shape, respectively. 514. In one embodiment, longitudinal first and second biasing members 513 and 514, respectively, are disposed in generally opposite positions, and the first and second resilient arms 101 and, respectively. Substantially parallel to 102. At least the distal end 515 of the first biasing member 513 strikes a portion of the second resilient arm 102 when the needle guard 510 is formed and placed on the needle 130 ( 63B), thereby applying a biasing force that assists in pressing the second elastic arm 102 against the shaft 131 of the needle 130 (along with a biasing force unique to the second elastic arm 102). The elastic arms 102 are aligned in the longitudinal direction (aligned, aligned in a row). In a similar manner, when at least the distal end 516 of the second biasing member 514 is placed on the needle 130 with the needle guard 510 formed, the distal end 516 of the first resilient arm 101 is It strikes a part (see FIG. 63B), thereby applying a biasing force (with a biasing force unique to the first elastic arm 101) that assists in pressing the first elastic arm 101 against the shaft 131 of the needle 130. Thus, it is aligned in the longitudinal direction with respect to at least a part of the first elastic arm 101 (aligned, aligned in a line).

  63B and 63C show the needle guard in a ready position prior to the needle guard being actuated to cover (cover, protect) the distal tip 134 of the needle 130. FIG. On the other hand, FIG. 63D shows the needle guard in a working state, in which the needle guard is stopped on the profile changing portion 132 on the needle shaft 131 and elastic. The distal ends 107, 108 of the arms 101, 102 are positioned so as to cover the distal tip 134. As shown in FIG. 63D, when the needle guard is in the activated state, the distal ends 515 and 516 of the biasing members 513 and 514 are continuously engaged with the arms 101 and 102. Such engagement advantageously assists in maintaining the arms 101, 102 in their respective working positions, and once the distal tip 134 is properly covered, the arms 101, 102. The outward force that may be exerted on is suppressed (resist, a force that resists or opposes the outward force is applied).

A plurality of features for stopping and / or engaging can be externally attached to or incorporated into the arms 101, 102 and / or the biasing members 513, 514, for the purpose of the needle guard 530. This is to assist in maintaining the state in which the urging members 513 and 514 are held on the arms 101 and 102 in the operating state. 64-68 show several examples of such features. In some embodiments, although not shown, the distal ends 515, 516 of the biasing members 513, 514 are disposed on the arms 101, 102 along at least a portion of the length of the arms 101, 102. Guided by a plurality of rails. In the embodiment of FIG. 64, notches / notches 531 and 532 are provided on the inner circumference of arms 101 and 102, respectively. In use, at least a portion of each of the distal ends 515, 516 of the biasing members 513, 514 is notched at the notches 532 and 531, as shown in FIG. 64B, when the needle guard 530 is in operation. Placed therein, thereby assisting in maintaining the state in which the arms 101 and 102 are held in a position covering the distal tip 134 of the needle 130. In one embodiment, as shown in FIG. 64C (cross-sectional view along line AA), the inner edge of arms 101 and / or 102 is highly rigid to increase the rigidity of arms 101 and / or 102. It is bent to form a back 533 having a back. In the embodiment of FIG. 65, ledges, ledges, ledges, ridges / shoulders 534 and 535 are formed on the inner edges of arms 101 and 102, respectively, to provide needle guards. At least a portion of each of the distal ends 515, 516 of the biasing members 513, 514 strikes the ledge / shoulders 534 and 535 when the 540 is in the active state. In one embodiment, at least the distal ends 515, 516 of the biasing members 513, 514 each have a width dimension W1, which is greater than the respective width dimension W2 of the arms 101 and 102. Figure 66A- In the embodiment of FIG. 66C, each arm 101 and 102, along at least a portion of the length of each arm 101 and 102, a pair of indentations (indentation, indentation, embossed can be dimples) 551a, have those compression molding a 551b, they dent 551a, 551b are recessed between their recess 551a and 551b (recess, resting portion, the recess, the pair recess 551a, the 551b They are lined up in the longitudinal direction so that there is a portion 552 between which the recesses are not continuous. As shown in FIG. 66C, at least a portion of each of the distal ends 515, 516 of the biasing members 513, 514 is placed in the recess 552 at least when the needle guard is in an active state. In the embodiment of FIGS. 67A and 67B, raised features 555 disposed on the outer surfaces of arms 101 and 102, respectively, as shown in FIG. 67B, biasing members 513, 514 At least a portion of each of the distal ends 515, 516 of the first and second distal ends 515, 516 form a surface that rests and locks at least when the needle guard is in action. In the embodiment of FIGS. 68A and 68B, each of the arms 101 and 102 includes an opening 556, with each opening 556 at each of the distal ends 515, 516 of the biasing members 513, 514. The formed tabs (tabs, protrusions, knobs, ears) 557 are accommodated. As shown in FIG. 68B, at least the respective tabs 557 are placed in the respective openings 556 when the needle guard is in the active state.

  69A-69C show a needle guard similar to the needle guard shown in FIGS. 67A and 67B. The difference is in the configuration of the distal end of the biasing member 514. As shown in FIGS. 69A and 69B, a protrusion or tab 518 extends radially inward from the distal end 516 and the needle guard is in an activated state as shown in FIGS. 69B and 69C. In this case, the inclined portion (bevel, inclined surface, groove) 136 of the needle 130 is at least partially covered (covered, covered, protected).

  Similar to the embodiment of FIG. 24, the needle guard incorporating the biasing member feature includes one arm 101 configured to cover (cover) and protect the distal tip of the needle. It is also possible to have only. As shown in FIGS. 70A and 70B, in that embodiment, the arm 102 has a termination at the location of the segment 560 and the guard does not have a biasing member 513. Similar to the previous embodiments, a biasing member 514 is provided to act against the outer surface of the arm 101.

  As shown in FIG. 71, several biasing members can be incorporated into a needle guard having a longitudinal member. The example of FIG. 71 shows a modification of the needle guard 400 of FIG. 30 that includes biasing members 513 and 514.

  A number of preferred embodiments are disclosed and described herein. However, it should be understood that the present invention should in no way be construed as limited to those examples.

The present invention provides the following embodiments.

  (Aspect 1)
  A safety needle device,
  A needle having a needle shaft and a distal tip, wherein the needle shaft has a profile changing portion whose profile changes at a position near the distal tip;
  A needle guard that is transitioned between a ready state and an activated state, wherein the distal tip of the needle has its distal tip at the needle guard. In an unprotected state that is not protected by a guard, but in the working state, the distal tip of the needle is in a protected state where the distal tip is protected by the needle guard. Some
  Including
  The needle guard includes an arm extending in a distal direction from the base, the base has an opening formed therein, and the needle guard includes the opening formed in the base. Slidably mounted on the needle shaft with the needle shaft passing therethrough, the arm having an elastic material and having a proximal section, a central section and a distal section;
  The needle guard further includes a longitudinal member, the longitudinal member extending distally from the same position as or near the base, and the needle guard between the preparation position and the working position. Slidable along the side of the needle shaft along its side when moved (alongside the needle shaft);
  The longitudinal member has a proximal end, a distal end, and a through passage extending between the proximal end and the distal end, and of the through passage, the proximal end of the longitudinal member A first portion located at the same or near position is sized to engage the profile change portion of the needle shaft to restrict the needle from moving proximally with respect to the needle guard. Have
  The longitudinal member has a length such that when the profile changing portion engages the first portion of the through passage, the entire distal tip of the needle is the length of the longitudinal member. It is to be arranged to be detained in the through passage,
  The longitudinal member has a proximal section and a distal section, and the proximal section of the longitudinal member has a base that is distal to the first section and distal from the first position on the proximal section of the longitudinal member. In the opening of the base in a slidable manner between a second position and a proximal section of the longitudinal member, the proximal section of the longitudinal member when the needle guard is in the ready state Located in the first position and located in the second position when the needle guard is in the working state;
  When the needle guard is in the ready state, the distal section of the arm is placed on the distal section of the longitudinal member at a location near the distal end of the longitudinal member, wherein At least a portion of the distal section of the arm is pressed against the outer side of the longitudinal member;
  The needle guard is configured such that when the base moves from the first position to the second position, the needle guard transitions from the preparation state to the action state,
  The distal section of the arm moves distally along the outer surface of the distal section of the longitudinal member to the distal end of the longitudinal member, where the distal section of the arm is Moving radially inwardly to at least partially cover the distal end of the longitudinal member;
  The longitudinal member restricts the needle from moving axially relative to the needle guard when the distal section of the arm at least partially covers the distal end of the longitudinal member. A safety device with sufficient rigidity.

  (Aspect 2)
  The safety device according to aspect 1, wherein a shoulder is present between the proximal section and the distal section of the longitudinal member, the shoulder extending in a distal direction on the longitudinal member. A safety device that defines a limit of movement to the second position.

  (Aspect 3)
  The safety device according to aspect 1, wherein a radially extending member is disposed on the proximal section of the longitudinal member, the radially extending member having the base distally over the longitudinal member. A safety device that defines a limit of movement to the second position.

  (Aspect 4)
  The safety device of aspect 1, wherein the distal section of the elongate member includes a recess, and at least a portion of the distal section of the arm is provided with the needle guard being prepared. A safety device that is placed in the recess when in a state.

  (Aspect 5)
  The safety device according to aspect 1, wherein there is a friction fit by frictional force between the opening and the proximal section of the longitudinal member, the friction fit being such that the base is the proximal A safety device that is fit enough to allow movement along the surface of the section.

  (Aspect 6)
  The safety device according to aspect 1, further comprising:
  A safety device including a recess in the outer surface of the proximal section of the longitudinal member, wherein the opening in the base is placed in the recess when the needle guard is in the ready state .

  (Aspect 7)
  The safety device according to aspect 6, wherein the opening expands when a force acting in a distal direction acts on the base, whereby the base is withdrawn from the recess, and in a distal direction. A safety device which can be advanced to reach the second position.

  (Aspect 8)
  The safety device of aspect 1, wherein the proximal section of the elongate member includes a frustoconical segment, the frustoconical segment having a proximal end having a first diameter and a second diameter. A distal end, wherein the second diameter is greater than the first diameter;
  The first position of the base is located at the proximal end of the frustoconical segment when the needle guard is in the ready state;
  The needle guard is configured such that, in the operating state, the second position of the base is located at the distal end of the frustoconical segment;
  In the ready state, the opening in the base has a diameter that is substantially the same as or slightly larger than the first diameter;
  The safety device is configured to expand to the second diameter when the base moves distally along the frustoconical segment and reaches the second position.

  (Aspect 9)
  The safety device of aspect 7, wherein radial expansion of the opening is at least partially facilitated by one or more slits in the base, the one or more slits being A safety device extending radially outward from the inner periphery of the opening.

  (Aspect 10)
  A safety device according to aspect 8, wherein radial expansion of the opening is at least partially facilitated by one or more slits in the base, the one or more slits being A safety device extending radially outward from the inner periphery of the opening.

  (Aspect 11)
  The safety device according to aspect 4, wherein the recess is configured to prevent the arm from rotating on the longitudinal member when the needle guard is in the ready state. A safety device configured to accommodate at least a portion of the position section.

  (Aspect 12)
  The safety device according to aspect 1, wherein at least a portion of the proximal section of the longitudinal member is keyed to the opening so that the needle guard is in the ready state. A safety device that inhibits the base and arm from rotating on the longitudinal member.

  (Aspect 13)
  The safety device according to aspect 1, wherein at least a portion of the proximal section of the longitudinal member is keyed to the opening so that the needle guard is in the ready state. And a safety device that inhibits the base and the arm from rotating on the longitudinal member when the needle guard is in the working state.

  (Aspect 14)
  The safety device of aspect 1, wherein the distal section of the arm includes a wall segment having a distal end;
  The wall segment and the central section of the arm are arranged such that the angular orientation relative to the longitudinal member is different from each other;
  The wall segment is bent inwardly toward the longitudinal member;
  The distal end of the wall segment is pressed against the outer surface of the longitudinal member when the needle guard is in the ready state;
  The distal end of the wall segment is disengaged from the longitudinal member when the needle guard is in the active state, thereby at least partially covering the distal end of the longitudinal member. Composed safety equipment.

  (Aspect 15)
  The safety device of aspect 1, wherein the distal section of the arm includes a wall segment having a distal end;
  The wall segment and the central section of the arm are arranged such that their angular orientations relative to the longitudinal member are different from each other;
  The wall segment is bent inwardly toward the longitudinal member;
  The distal end of the wall segment is pressed against the outer surface of the longitudinal member when the needle guard is in the ready state;
  The distal end of the wall segment is configured to detach from the longitudinal member when the needle guard is in the operative state, thereby completely covering the distal end of the longitudinal member. Safety equipment.

  (Aspect 16)
  The safety device of aspect 14, wherein the distal end of the wall segment includes a lip.

  (Aspect 17)
  The safety device according to aspect 4, wherein the elongate member includes a feature at the same or near position as a distal end thereof, wherein the feature is when the needle guard is in the active state. A safety device cooperating with the lip to secure the distal section of the arm to the distal end of the longitudinal member.

  (Aspect 18)
  The safety device according to aspect 15, wherein the wall segment and the distal end of the longitudinal member are positioned such that the wall segment completely covers the distal end of the longitudinal member. A safety device that cooperates with each other to at least partially form a seal.

  (Aspect 19)
  19. The safety device of aspect 18, wherein one or both of the wall segment and the distal end of the elongate member are surface treated to assist in forming the seal.

  (Aspect 20)
  The safety device according to aspect 19, wherein one or both of the wall segment and the distal end of the longitudinal member are coated with a sealing agent.

  (Aspect 21)
  The safety device according to aspect 1, wherein the distal end of the elongate member includes a flange having a distal facing surface.

  (Aspect 22)
  The safety device according to aspect 1, wherein the base and the arm of the needle guard have an integral structure.

  (Aspect 23)
  The safety device according to aspect 1, wherein the feature of the longitudinal member in the vicinity of the proximal end of the through passage is in a position where the proximal section of the through passage covers the profile changing portion. In some cases, a safety device that inhibits rotational movement between the needle guard and the needle.

  (Aspect 24)
  The safety device according to aspect 1, wherein the distal end of the elongate member includes a shape-matching material having a property that conforms to the other.

  (Aspect 25)
  The safety device according to aspect 14, wherein the wall segment includes a shape-matching material having a property that conforms to the other.

  (Aspect 26)
  15. The safety device according to aspect 14, wherein each of the wall segment and the distal end of the elongate member includes a shape-matching material having a property that conforms to the other.

  (Aspect 27)
  The safety device of aspect 1, wherein the elongate member includes a reservoir for collecting blood or bodily fluid at a distal end thereof, wherein the blood or bodily fluid is in the active state of the needle guard. And a safety device that may flow out of the distal tip of the needle.

  (Aspect 28)
  28. The safety device according to aspect 27, further comprising an absorbent placed in the reservoir.

  (Aspect 29)
  29. The safety device according to aspect 28, wherein the absorbent contains an antimicrobial agent or an antibiotic.

  (Aspect 30)
  A needle assembly,
  A needle having a needle shaft and a distal tip, wherein the needle shaft has a profile changing portion whose profile changes at a position near the distal tip;
  A needle guard capable of moving between a preparation position and an action position on the needle;
  Including
  The needle guard includes an arm extending distally from the base, the base having an opening formed therein, and the needle guard including the opening formed in the base. With the needle shaft passing, it is slidably mounted on the needle shaft,
  The opening is sized to engage the profile change portion of the needle shaft to limit movement between the needle and the needle guard;
  The arm has a distal section that is pressed against the side of the needle shaft when the needle is in the ready position;
  The needle guard further includes a longitudinal member, the longitudinal member having a through passage extending between a proximal end and a distal end of the longitudinal member;
  The elongate member extends distally from the same or near position as the base and along the side of the needle shaft as the needle guard is moved between the ready position and the working position. Can slide along the length of the needle shaft (alongside the needle shaft)
  The longitudinal member has a length such that the entire distal tip of the needle is longitudinal when the profile change portion substantially engages the opening in the base. The distal section of the arm disengages from the needle shaft and moves radially inwardly, thereby causing the distal member of the longitudinal member to move inwardly. It is intended to at least partially cover the top edge,
  The longitudinal member restricts the needle from moving axially relative to the needle guard when the distal section of the arm at least partially covers the distal end of the longitudinal member. Needle assembly with sufficient rigidity.

  (Aspect 31)
  31. The needle assembly according to aspect 30, wherein the distal section of the arm is the needle assembly when the profile change portion substantially engages the opening in the base of the needle guard. A needle assembly that disengages from the shaft and completely covers the distal end of the longitudinal member.

  (Aspect 32)
  31. The needle assembly according to aspect 30, wherein the longitudinal member is applied inwardly such that any portion of the longitudinal member is directed toward the needle shaft when the needle guard is in the ready position. A needle assembly attached directly to the base so as not to be biased.

  (Aspect 33)
  31. The needle assembly according to aspect 30, wherein the arm and the elongate member are integrally formed from a single material.

  (Aspect 34)
  31. The needle assembly according to aspect 30, wherein the distal end of the elongate member includes a conformable material having a shape conformable property with a counterpart.

  (Aspect 35)
  31. The needle assembly according to aspect 30, wherein the distal section of the arm includes a conformable material having a shape-fit property with a counterpart.

  (Aspect 36)
  31. The needle assembly according to aspect 30, wherein each of the distal section of the arm and the distal end of the elongate member includes a conformable material having a shape conforming property to the other. assembly.

  (Aspect 37)
  31. The needle assembly according to aspect 30, wherein the elongate member includes a reservoir that collects blood or bodily fluid at the same location or near its distal end, the blood or bodily fluid being contained in the needle guard. Can flow out of the distal tip of the needle when
  The reservoir is configured to surround an outer periphery of the distal tip of the needle when the needle guard is in the working position;
  The reservoir has an opening facing in a distal direction, the opening of the needle guard being advanced distally from the preparation position to the working position by the opening. A needle assembly that can slide along the side of the shaft along the length of the needle shaft.

  (Aspect 38)
  31. The needle assembly according to aspect 30, wherein the elongate member is entirely disposed between the base and the distal section of the arm.

  (Aspect 39)
  A needle assembly,
  A needle having a needle shaft and a distal tip, wherein the needle shaft has a profile changing portion whose profile changes at a position near the distal tip;
  A needle guard capable of moving between a preparation position and an action position on the needle;
  Including
  The needle guard includes an arm extending distally from the base, the base having an opening formed therein, and the needle guard including the opening formed in the base. With the needle shaft passing, it is slidably mounted on the needle shaft,
  The arm has a distal section that is pressed against the side of the needle shaft when the needle is in the ready position;
  The needle guard further includes a longitudinal member, the longitudinal member having a through passage extending between a proximal end and a distal end of the longitudinal member;
  The elongate member extends distally from the same or near position as the base and along the side of the needle shaft as the needle guard is moved between the ready position and the working position. Can slide along the length of the needle shaft (alongside the needle shaft)
  The through-passage of the longitudinal member has a small cross-sectional area having a smaller cross-sectional area than other parts at a certain position on the length of the longitudinal member, and the needle guard has the function as described above. Having a size that engages the profile change of the needle shaft to limit movement of the needle relative to the needle guard when in position;
  The longitudinal member has a length that is such that the distal tip of the needle when the profile change portion substantially engages the opening in the base of the needle guard. And the distal section of the arm moves away radially from the needle shaft and thereby moves radially inwardly, thereby allowing the longitudinal member to be placed in the through passage of the longitudinal member. And at least partially covering the distal end of the longitudinal member;
  The longitudinal member restricts the needle from moving axially relative to the needle guard when the distal section of the arm at least partially covers the distal end of the longitudinal member. Needle assembly with sufficient rigidity.

  (Aspect 40)
  40. The needle assembly according to aspect 39, wherein the distal section of the arm is the needle assembly when the profile change portion substantially engages the opening in the base of the needle guard. A needle assembly that disengages from the shaft and completely covers the distal end of the longitudinal member.

  (Aspect 41)
  40. The needle assembly according to aspect 39, wherein the longitudinal member is applied inwardly such that any portion of the longitudinal member is directed toward the needle shaft when the needle guard is in the ready position. A needle assembly attached directly to the base so as not to be biased.

  (Aspect 42)
  40. The needle assembly according to aspect 39, wherein the arm and the elongate member are integrally formed from a single material.

  (Aspect 43)
  40. The needle assembly according to aspect 39, wherein the distal end of the elongate member includes a conformable material having a shape conformable property with a counterpart.

  (Aspect 44)
  40. The needle assembly according to aspect 39, wherein the distal section of the arm includes a conformable material having a shape-fit property with a counterpart.

  (Aspect 45)
  40. The needle assembly according to aspect 39, wherein each of the distal section of the arm and the distal end of the elongate member includes a conformable material having a shape conforming property to a counterpart. assembly.

  (Aspect 46)
  40. The needle assembly according to aspect 39, wherein the elongate member includes a reservoir for collecting blood or bodily fluid at the same or near position as a distal end thereof, the blood or bodily fluid being transmitted by the needle. Can flow out of the distal tip of the needle when in the working position;
  The reservoir is configured to surround an outer periphery of the distal tip of the needle when the needle guard is in the working position;
  The reservoir has an opening facing in a distal direction, the opening of the needle guard being advanced distally from the preparation position to the working position by the opening. A needle assembly that can slide along the side of the shaft along the length of the needle shaft.

  (Aspect 47)
  40. The needle assembly according to aspect 39, wherein the elongate member is entirely disposed between the base and the distal section of the arm.

  (Aspect 48)
  A guidewire introducer,
  A needle having a needle shaft and a distal tip, wherein the needle shaft has a profile changing portion whose profile changes at a position near the distal tip;
  A needle guard that is transitioned between a preparation position and an operating position, wherein the distal tip of the needle is in an unprotected state in which the distal tip is not protected by the needle guard. in the unprotected state, but in the working position, the distal tip of the needle is in a protected state in which the distal tip is protected by the needle guard.
  Including
  The needle guard includes an arm extending in a distal direction from the base, the base has an opening formed therein, and the needle guard includes the opening formed in the base. With the needle shaft passing, it is slidably mounted on the needle shaft,
  The needle guard further includes a longitudinal member, the longitudinal member extending distally from the same position as or near the base, and the needle guard between the preparation position and the working position. Slidable along the side of the needle shaft along its side when moved (alongside the needle shaft);
  The longitudinal member has a proximal end, a distal end, and a through passage extending between the proximal end and the distal end, and of the through passage, the proximal end of the longitudinal member A first portion located at or near the same position engages the profile change portion of the needle shaft to limit the needle guard from moving distally over the needle shaft. Has a size,
  The longitudinal member has a length such that when the profile changing portion engages the first portion of the through passage, the entire distal tip of the needle is the length of the longitudinal member. It is to be arranged to be detained in the through passage,
  When the needle guard is in the ready position, the distal section of the arm is pressed against the outer side of the needle shaft;
  The needle guard moves distally along the outer side of the distal section of the longitudinal member when the needle guard transitions from the ready position to the working position, Movement is such that when the needle guard reaches the working position, the distal section of the arm moves radially inward, thereby at least partially covering the distal end of the longitudinal member. Configured to be done until
  The longitudinal member restricts the needle from moving axially relative to the needle guard when the distal section of the arm at least partially covers the distal end of the longitudinal member. Guide wire introducer with sufficient rigidity.

  (Aspect 49)
  The guidewire introducer according to aspect 48, wherein a proximal end of the needle passes through the needle hub and is coupled to the needle hub.
  The guidewire introducer further includes a housing, the housing having a proximal end and an open distal end;
  The proximal end of the housing is connected to the needle hub;
  The needle guard is placed in the housing when in the ready position;
  A guide wire introducer that is placed outside the housing when the needle guide is in the working position.

  (Aspect 50)
  The guidewire introducer according to aspect 49, further comprising an elastic member located within a proximal section of the housing,
  The elastic member has a proximal end and a distal end;
  When the needle guard is in the ready position, the resilient member is in compression and is against the needle guard to bias the needle guard toward the distal tip of the needle. Guidewire introducer that is configured to work.

  (Aspect 51)
  51. A guidewire introducer according to aspect 50, wherein the needle guard is held in the preparation position in the housing by a retaining element, the retainer having a first position and a second position. Can move between
  When the retainer is in the first position, the retainer engages the needle guard to hold the needle guard in the ready position;
  When the retainer is in the second position, the retainer is disengaged from the needle guard, so that the needle guard is attached to the distal tip of the needle by the elastic member. A guide wire introducer that is propelled toward the working position.

  (Aspect 52)
  49. A guidewire introducer according to aspect 48, wherein the distal end of the elongate member includes a conformable material having a shape-fit property with a counterpart.

  (Aspect 53)
  49. A guidewire introducer according to aspect 48, wherein the distal section of the arm includes a shape-matching material having a shape-fit property with a counterpart.

  (Aspect 54)
  49. A guidewire introducer according to aspect 48, wherein each of the distal section of the arm and the distal end of the elongate member includes a conformable material having a shape-fit property with a counterpart. Guide wire introducer.

  (Aspect 55)
  49. A guidewire introducer according to aspect 48, wherein the elongate member includes a reservoir for collecting blood or bodily fluid at the same or near position as a distal end thereof, the blood or bodily fluid comprising the needle A guidewire introducer that can flow out of the distal tip of the needle when a guard is in the working position.

  (Aspect 56)
  49. A guidewire introducer according to aspect 48, wherein the longitudinal member includes a large diameter distal portion that is larger in diameter than a peripheral portion, the large diameter distal portion being the distal end of the longitudinal member. And a bush is retained in the cavity, and the needle is positioned concentrically within the longitudinal member, such that the needle passes axially through the longitudinal member. A guidewire introducer arranged to wipe blood or body fluid from the outer surface of the needle when moving.

  (Aspect 57)
  A guidewire introducer,
  A needle having a needle shaft and a distal tip, wherein the needle shaft has a profile changing portion whose profile changes at a position near the distal tip;
  A needle guard that is transitioned between a preparation position and an operating position, wherein the distal tip of the needle is in an unprotected state in which the distal tip is not protected by the needle guard. in the unprotected state, but in the working position, the distal tip of the needle is in a protected state in which the distal tip is protected by the needle guard.
  Including
  The needle guard includes an arm extending in a distal direction from the base, the base has an opening formed therein, and the needle guard includes the opening formed in the base. With the needle shaft passing, it is slidably mounted on the needle shaft,
  The opening is sized to engage the profile change portion of the needle shaft to restrict the needle guard from moving distally over the needle shaft;
  The needle guard further includes a longitudinal member, the longitudinal member extending distally from the same position as or near the base, and the needle guard between the preparation position and the working position. Slidable along the side of the needle shaft along its side when moved (alongside the needle shaft);
  The longitudinal member has a proximal end, a distal end, and a through passage extending between the proximal end and the distal end;
  The longitudinal member has a length such that when the profile changing portion engages the first portion of the through passage, the entire distal tip of the needle is the length of the longitudinal member. It is to be arranged to be detained in the through passage,
  When the needle guard is in the ready position, the distal section of the arm is pressed against the outer side of the needle shaft;
  The needle guard moves distally along the outer side of the distal section of the longitudinal member when the needle guard transitions from the ready position to the working position, Movement is such that when the needle guard reaches the working position, the distal section of the arm moves radially inward, thereby at least partially covering the distal end of the longitudinal member. Configured to be done until
  The longitudinal member restricts the needle from moving axially relative to the needle guard when the distal section of the arm at least partially covers the distal end of the longitudinal member. Guide wire introducer with sufficient rigidity.

  (Aspect 58)
  A guidewire introducer according to aspect 57, wherein a proximal end of the needle passes through the needle hub and is coupled to the needle hub.
  The guidewire introducer further includes a housing, the housing having a proximal end and an open distal end;
  The proximal end of the housing is connected to the needle hub;
  The needle guard is placed in the housing when in the ready position;
  A guide wire introducer that is placed outside the housing when the needle guide is in the working position.

  (Aspect 59)
  The guidewire introducer according to aspect 58, further comprising an elastic member located within a proximal section of the housing,
  The elastic member has a proximal end and a distal end;
  When the needle guard is in the ready position, the resilient member is in compression and is against the needle guard to bias the needle guard toward the distal tip of the needle. Guidewire introducer that is configured to work.

  (Aspect 60)
  60. A guidewire introducer according to aspect 59, wherein the needle guard is held in the ready position within the housing by a retaining element, the retainer being in a first position and a second position. Can move between
  When the retainer is in the first position, the retainer engages the needle guard to hold the needle guard in the ready position;
  When the retainer is in the second position, the retainer is disengaged from the needle guard, so that the needle guard is attached to the distal tip of the needle by the elastic member. A guide wire introducer that is propelled toward the working position.

  (Aspect 61)
  58. A guidewire introducer according to aspect 57, wherein the distal end of the elongate member includes a shape-matching material having a shape-fit property with a counterpart.

  (Aspect 62)
  58. A guidewire introducer according to aspect 57, wherein the distal section of the arm includes a shape-matching material having a shape-fit property with a counterpart.

  (Aspect 63)
  58. A guidewire introducer according to aspect 57, wherein each of the distal section of the arm and the distal end of the elongate member includes a conformable material having the property of conformally conforming to a counterpart. Guide wire introducer.

  (Aspect 64)
  58. A guidewire introducer according to aspect 57, wherein the elongate member includes a reservoir for collecting blood or bodily fluid at the same or near position as its distal end, the blood or bodily fluid being the needle A guidewire introducer that can flow out of the distal tip of the needle when a guard is in the working position.

  (Aspect 65)
  58. A guidewire introducer according to aspect 57, wherein the longitudinal member includes a large diameter distal portion having a larger diameter than a peripheral portion, the large diameter distal portion being the distal end of the longitudinal member. And a bush is retained in the cavity, and the needle is positioned concentrically within the longitudinal member, such that the needle passes axially through the longitudinal member. A guidewire introducer arranged to wipe blood or body fluid from the outer surface of the needle when moving.

Claims (12)

A safety needle device,
A needle having a needle shaft and a distal tip, wherein the needle shaft has a profile changing portion whose profile changes at a position near the distal tip;
A needle guard that is transitioned between a ready state and an activated state, wherein the distal tip of the needle has its distal tip at the needle guard. In an unprotected state that is not protected by a guard, but in the working state, the distal tip of the needle is in a protected state where the distal tip is protected by the needle guard. Including some and
The needle guard includes an arm extending in a distal direction from the base, the base has an opening formed therein, and the needle guard includes the opening formed in the base. Slidably mounted on the needle shaft with the needle shaft passing therethrough, the arm having elasticity and having a proximal section, a central section and a distal section;
The needle guard further includes a longitudinal member, the longitudinal member extending distally from the same position as or the vicinity of the base, and the needle guard between the ready state and the working state. Slidable along the side of the needle shaft along its side when moved (alongside the needle shaft);
The longitudinal member has a proximal end, a distal end, and a through passage extending between the proximal end and the distal end, and of the through passage, the proximal end of the longitudinal member A first portion located at the same or near position is sized to engage the profile change portion of the needle shaft to restrict the needle from moving proximally with respect to the needle guard. Have
The longitudinal member has a length such that when the profile changing portion engages the first portion of the through passage, the entire distal tip of the needle is the length of the longitudinal member. It is to be arranged to be detained in the through passage,
The longitudinal member has a proximal section and a distal section, and the proximal section of the longitudinal member has a base that is distal to the first section and distal from the first position on the proximal section of the longitudinal member. In the opening of the base in a slidable manner between a second position and a proximal section of the longitudinal member, the proximal section of the longitudinal member when the needle guard is in the ready state Located in the first position and located in the second position when the needle guard is in the working state;
When the needle guard is in the ready state, the distal section of the arm is placed on the distal section of the longitudinal member at a location near the distal end of the longitudinal member, wherein At least a portion of the distal section of the arm is pressed against the outer side of the longitudinal member;
The needle guard is configured such that when the base moves from the first position to the second position, the needle guard transitions from the preparation state to the action state,
The distal section of the arm moves in a distal direction along the outer surface of the distal section of the longitudinal member beyond the distal end of the longitudinal member, and in that position, the arm of the arm The distal section moves radially inward to at least partially cover the distal end of the longitudinal member;
The longitudinal member restricts the needle from moving axially relative to the needle guard when the distal section of the arm at least partially covers the distal end of the longitudinal member. With sufficient rigidity,
At least a portion of the proximal section of the longitudinal member is keyed to the opening in the base so that when the needle guard is in the ready state, the base and A safety device that inhibits the arm from rotating on the longitudinal member. The safety device of claim 1, wherein the key coupling is such that the base and arm rotate over the longitudinal member as the base is advanced axially distally over the longitudinal member. A safety device that couples the at least a portion of the proximal section of the elongate member with the opening in the base to inhibit. The safety device of claim 1, wherein there is a friction fit between the opening and the proximal section of the longitudinal member due to frictional forces, the friction fit being achieved when the base is in the longitudinal direction. A safety device that is fit enough to allow movement along the surface of the proximal section of the member . The safety device of claim 1, further comprising:
A safety device including a recess in the outer surface of the proximal section of the longitudinal member, the opening of the base being placed in the recess when the needle guard is in the ready state . 5. The safety device according to claim 4, wherein the opening expands when a force acting in a distal direction acts on the base, whereby the base is withdrawn from the recess and distally. A safety device capable of moving forward in the direction and reaching the second position.   6. The safety device of claim 5, wherein the radial expansion of the opening is at least partially facilitated by one or more slits in the base, the one or more slits being A safety device extending radially outward from the inner periphery of the opening. The safety device of claim 2, wherein at least a portion of the proximal section of the elongate member is keyed to the opening so that the needle guard is in the preparation. The base and arm rotate over the longitudinal member as the base is axially advanced distally over the longitudinal member when in the state and when the needle guard is in the active state Safety device that inhibits you. The safety device of claim 1, wherein the distal section of the arm includes a lip segment having a distal end;
The lip segment and the central section of the arm are arranged such that their angular orientation relative to the longitudinal member is different from each other;
The lip segment is bent inwardly toward the longitudinal member;
The distal end of the lip segment is pressed against the outer surface of the longitudinal member when the needle guard is in the ready state;
The distal end of the lip segment is configured to disengage from the longitudinal member when the needle guard is in the active state, thereby completely covering the distal end of the longitudinal member. Safety equipment. 9. The safety device of claim 8, wherein the lip segment and the distal end of the longitudinal member are positioned such that the lip segment completely covers the distal end of the longitudinal member. A safety device that cooperates with each other to at least partially form a seal. 10. The safety device of claim 9, wherein one or both of the lip segment and the distal end of the elongate member are surface treated to assist in forming the seal. 11. A safety device according to claim 10, wherein one or both of the lip segment and the distal end of the elongate member are coated with a sealing agent.   The safety device of claim 1, wherein the distal end of the elongate member includes a flange having a distal facing surface.

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