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    • 专利摘要:
    needle assembly and method for assembling needle assembly protective intravenous (iv) catheters are described herein, comprising a catheter connection (102) with a catheter tube (112), a needle with a needle connector, and a needle guard (204). the needle guard is configured to be positioned, at least partially, within an internal space of the needle connector and is retained there for mechanical engagement between the two. following removal of the needle from the catheter connection, the needle guard is configured to disengage from the catheter connection and connect over a needle tip to protect the needle tip from accidental needle sticking. the needle guard features an angled end section configured with a length and a width to secure the needle tip within a tip holding space behind the angled end section.
    公开号:BR112013002767B1
    申请号:R112013002767-3
    申请日:2011-07-26
    公开日:2021-09-14
    发明作者:Kevin Woehr
    申请人:B. Braun Melsungen Ag；
    IPC主号:
    专利说明:

    [001] This is an invention patent application based on US Priority No. 61/371,054, filed on August 5, 2010, the contents of which are expressly incorporated herein by reference. BACKGROUND OF THE INVENTION
    [002] The invention relates generally to safety needle sets and safety intravenous catheters (IV catheters) and particularly to a safety IV catheter, in which the needle tip is automatically covered after withdrawal to prevent accidental needle tip piercing. DESCRIPTION OF TECHNICAL STATUS
    [003] IV catheters are primarily used to administer fluids directly into a patient's vascular system. Typically, a catheter is inserted into a patient's vein by a healthcare professional. Immediately after removing the needle from the patient's vein, the exposed needle tip creates a risk of accidental puncture, which leaves the healthcare professional vulnerable to transmission of many dangerous blood-borne pathogens.
    [004] This danger has led to the development of safety IV catheters that cover or conceal the needle tip using many different means. However, some developed IV catheters sometimes fail to prevent unintentional needle punctures from occurring. For example, on some safety IV catheters, turning the needle during removal may cause the needle tip to slide out beyond the confines of the needle guard.
    [005] In some safety IV catheters, the engagement that typically occurs between the needle and the needle guard during needle withdrawal is unreliable. SUMMARY
    [006] The various embodiments of this safety IV catheter have several features, none of which is solely responsible for its expected attributes. The prominent features of these embodiments will now be discussed briefly, without any intention of limiting the scope of the embodiments expressed herein.
    [007] In certain embodiments, a needle guard comprising a non-metallic base portion comprising a hole, a proximally facing surface and a distally facing surface are incorporated. The needle guard further includes a first arm that includes a first free end and a second arm that includes a second free end that generally extends axially from the base portion in a distal direction. The first free end extending beyond the second free end and including an angled end section that extends toward the second arm. Where the angled distal end section comprises a length and width configured to retain a needle having a needle diameter within a tip-carrying space and where the length and width of the angled end section is greater than the needle diameter.
    [008] In other embodiments, a catheter assembly comprising a needle shield comprising a non-metallic base portion comprising a hole, a proximally facing surface and a distally facing surface is presented. The needle guard includes a first arm, which includes a first free end, and a second arm, which includes a second free end that generally extends axially from the base portion in a distal direction. The first free end extends beyond the second free end, including a terminal angled section, comprising a length and a width extending toward the second arm, and a needle having a diameter. Where the first arm and second arm are angled to move between a ready position in which the angled end section confines a needle having a needle tip and a shielded position in which the needle tip is confined in a cutting edge carrier space. Where the length and width of the angled end section is greater than the diameter of the needle.
    [009] In another embodiment, a safety IV catheter comprising a needle hub with a needle and a needle hub with a catheter tube and a tip guard is presented. The tip guard is made of a first material and has a proximal wall comprising an opening defining an orifice and two arms extending distally from the proximal wall, with at least one of the arms comprising an angled end section shaped. to cover a distal end of the other arm in a protective position. Where an insert made of a second material comprising an opening is aligned with the proximal wall opening and where the proximal wall opening requires less force to widen the insert opening.
    [0010] Another embodiment of the present assembly includes a needle assembly comprising a non-metallic base portion, comprising a wall having a hole, a hole length, a hole diameter, a proximally facing surface, and a surface. turned distally. The shield further includes a first arm that includes a first free end and a second arm that includes a second free end that generally extends axially in a distal direction from the base portion, the first free end. extending beyond the second free end and including an angled end section comprising a first side edge, a second side edge, a length and a width extending toward the second arm. The shield includes a needle tip carrier space defined at least in part by the base portion, the first arm, the second arm and the angled end section. The set also includes a needle that has a tip and a diameter. Where the first arm and second arm are angled so as to move between a ready position in which the angled end section encloses the needle, and a protected position in which the needle tip is confined within a tip-bearing space of needle tip, and where the length and width of the angled end section are greater than a needle diameter and cooperate with the hole length and the hole diameter to confine the needle tip within the needle tip-carrying space.
    [0011] Yet another feature of the present patent application is a method for assembling a needle assembly. The method comprises providing a needle having a shaft, a tip and a change in profile near the needle tip in a needle hub and placing a sliding needle guard over the needle shaft. The needle guard comprising a non-metallic base portion, which comprises a hole, a hole length, a hole diameter, a proximally facing surface and a distally facing surface. The needle guard further comprising a first arm, which includes a first free end, and a second arm, which includes a second free end, which generally extends axially in a distal direction from the portion. base, the first free end extending beyond the second free end and including an angled end section comprising a first side edge, a second side edge, a length and a width extending toward the second arm. The needle guard further comprising a needle tip carrier space defined at least in part by the base portion, the first arm, the second arm and the angled end section. Where the length and width of the angled distal end section is greater than a needle diameter and cooperate with the hole length and the hole diameter to confine the needle tip within the needle tip-carrying space. The method further comprising moving the needle shield to a proximal position on the needle shaft such that the angled end section is based on the needle shaft and spaced with respect to the needle shield. BRIEF DESCRIPTION OF THE DRAWINGS
    [0012] The various embodiments of the present sets of IV needle and catheters will be presented below, with an emphasis on highlighting the advantageous features. These embodiments describe the new and non-obvious safety IV catheters shown in the accompanying drawings, which are for illustrative purposes only. These drawings include the following figures, in which numbers indicate similar parts: FIG. 1 is a top view of a safety catheter hub having flaps, in accordance with one embodiment; FIG. 2 is a cross-sectional view of the safety catheter hub of FIG. 1 including a needle, according to one embodiment; FIG. 2A is a cross-sectional view of a modified safety catheter assembly provided in accordance with an embodiment; FIG. 3A is a side view of a needle guard, in accordance with the various embodiments; FIG. 3B is an end view of the needle guard of FIG. 3A taken along line 3B-3B; FIG. 3C is a schematic top or plan view of the needle guard of FIG. 3A depicting the relationships between FIG. 4A is a side view of a needle guard in a protected position, in accordance with various embodiments; FIG. 4B is a cross-sectional view of the needle guard of FIG. 4A; FIG. 5 is a side view of a needle guard in accordance with various embodiments; and FIG. 6 is a cross-sectional view of an alternative configuration of the needle guard of FIG. 5, according to an embodiment. DETAILED DESCRIPTION
    [0013] The detailed description set forth below in conjunction with the accompanying drawings is intended to serve as a description of the currently preferred embodiments of safety IV catheters provided in accordance with the present apparatus, system and method, and is not intended to represent only forms in the which present apparatus, system and method can be constructed or used. The description sets out the features and steps for the construction and use of the safety IV catheters of the present apparatus, system and method in connection with the illustrated embodiments. However, it should be understood that the same equivalent functions and structures can be performed by different embodiments which are also intended to be placed within the spirit and scope of the invention. Also, as noted elsewhere in this instrument, equal element numbers are intended to indicate the same or similar elements or characteristics.
    [0014] The figures and their written descriptions indicate that certain components of the embodiments are integrally formed and other components are formed as separate parts. Those of ordinary skill in the art, moreover, will recognize that the components shown and described in this instrument as being formed as separate parts may, in alternative embodiments, be integrally formed. Furthermore, as the term is used herein, the term integral describes a single piece, which can be formed in isolation or realized in isolation, while a unitary piece means monolithically formed.
    [0015] FIG. 1 is an illustration of a catheter housing 100, in accordance with one embodiment. Catheter housing 100 includes a catheter hub body 102. Catheter hub body or hub 102 defines an inner chamber 104 (FIG. 2), which extends between a proximal end 106 and a distal end 108 of the housing body. hub 102. A hollow catheter tube 112 is affixed to the distal end 108 of hub body 102 using a bushing or retainer 203 (FIG. 2), which are known in the industry. An axial or proximal opening 110 is defined in the proximal end 106 of the hub body 102. The axial opening 110 is configured to receive a hollow needle hub, which includes a needle at its distal end and a flash chamber at its proximal end. The axial opening 110 can incorporate a female Luer cone, which is typical in the industry. Alternatively, the needle hub confines the end of the proximal end 106, but does not enter the inner chamber 104. As used in this application, the term distal end or proximal end means an end at a general distal location or at a general proximal location , respectively, or more distal end or more proximal end, respectively. If only a more distal end or more proximal end is intended, the text will indicate so.
    [0016] In some embodiments, hub body 102 includes a port 114, which extends from hub body 102 in a direction generally perpendicular to the axial direction of inner chamber 104. In another embodiment, port 114 is not included. In yet another embodiment, the port comprises a valve or a piston to regulate fluid flow through the opening of port 114. For example, port 114 and the valve may incorporate a needleless access valve. Exemplary needleless access valves are disclosed in Patent Nos. 5,439.45, 6,036,171, and 6,543,745, the contents of which are expressly incorporated herein by reference. Alternatively or in addition to this, a plastic or elastomeric sleeve 82 (FIG. 2) can be used to control the flow through port 114, which is well known in the industry. Glove 82 is configured to fall off upon application of fluid pressure caused by, for example, a syringe. In some embodiments, wings 116 may be provided on hub body 102. Wings 116 may be positioned to extend outwardly from hub body in a plane perpendicular to port 114 when port 114 is positioned on hub body 102.
    [0017] FIG. 2 is a cross-sectional view of the safety catheter hub 100 of FIG. 1, according to an embodiment. In general, as shown in FIG. 2, a needle is received through the axial opening 110 and extends through the inner chamber 104. At the distal end 108 of the hub body 102, the needle 202 extends into and through the tubular catheter 112, and the needle tip extends beyond the distal end of tubular catheter 112.
    [0018] In one embodiment, a needle guard 204 is incorporated and slidably disposed in the needle 202. The needle guard 204 includes a base portion 205, which defines an orifice 207 that extends axially therethrough to receive the needle 202. As described in more detail below, the hole 207 is configured in size and shape to allow the needle 202 to be slidably received therein. Needle guard 204 also includes a first arm 206 and a second arm 208 which generally extends axially from the base portion 205.
    The base portion 205 further comprises a wall comprising proximally facing wall surfaces 60 and distally facing wall surfaces 62 (See also FIG. 3A). A gap 50 is provided between the two arms 206, 208, which are defined by the edges of the two arms and the distally facing wall surfaces 62 of the base portion 205. The first arm 206 has a first free or recessed end 210, and the second arm 208 has a second free or cantilever end 212. The first free end 210 extends beyond the second free end 212 and has an angled end section 214, which may be designated as a wall, a shield section, a locking tip or a cap. Angled end section 214 extends toward second arm 208. In the embodiment shown, angled end section 214, first arm 206, and base portion 205 are formed contiguously or unitarily with one another. Also, as used herein, the terms first and second are merely identifying and do not necessarily limit the physical characteristics of the arms. For example, when viewed from another perspective, the first arm can be called the second arm and vice versa.
    [0020] In one embodiment, the needle shield 204 is made of a unitary plastic, a thermoplastic or an elastomeric material or any combination thereof, such as a thermoplastic elastomer (TPE). For example, the needle guard 204 may be made of molded memory elastomer so that the first arm 206 self-bias towards the second arm, and the angled end section 214 overlaps the end of the second arm, at least partially. The use of molded or flexible memory material allows the needle guard 204 to tilt to a closed or guard position without external biasing forces, as discussed further below. More particularly, the first arm 206, the second arm 208, or both the first arm and the second arm are configured to pivot radially inwardly to cover the needle tip using molded memory plastic or elastic material. . After the arm movement, the gap 50 provided between the two arms is reduced. In other embodiments, the needle guard 204 is made of multiple pieces and/or is made of a combination of different materials, such as plastic or metal, for example, polycarbonate and stainless steel.
    [0021] In the ready position of the safety catheter hub 100 shown in FIG. 2, the needle guard 204 is located at the proximal end 106 of the catheter hub 102. As shown, the needle guard is located substantially within the inner chamber 104. It may also be located entirely in the inner chamber 104 or located partially outside of the axial opening 110. The needle 202 extends through the orifice of the needle guard 204 and into the inner chamber 104. The needle extends distally through the catheter 112 so that the tip of the needle 202 extends. beyond the distal end of the catheter tube 112. In the ready position, when the needle 202 extends through the needle guard 204, the angled end section 214 is supported on the needle 202, as contacted or confined by the needle, which causes the first free end 210 of the first arm 206 to be biased or biased away from the second free end 212 of the second arm 208. As shown, the end supported at a corner 212 of the second arm 208 is also tilted by the needle in the ready position.
    [0022] To axially locate the needle guard 204 within the catheter hub 102 in the ready position and, during the transition from the ready position to a used position, the needle guard incorporates a hub engagement section 64 and the hub 102 incorporates a protective engagement section 66. As shown, the hub engagement section 64 is a groove, and the protective engagement section 66 is a projection that projects from the inner wall surface of the hub 102. In another embodiment , the configuration is inverted so that the hub engagement section 64 is a projection, and the shield engagement section 66 is a groove. In one embodiment, the engagement is not circumferential but only partial around the needle guard so that only one of the arms is engaged with the hub. In another embodiment, the engagement is circumferential around the needle guard. As shown, cube 102 incorporates both a recess and a projection. In another embodiment, the hub incorporates a projection to form a reduced diameter interior cavity, but not a recess. When the angled end section 214 of the shield is in contact with the needle in the ready position, the needle pushes the angled end section radially outward with respect to the needle shaft so that the hub engagement section 64 engages the engagement section. shield 66 to retain the needle shield within the inner cavity of the hub 102.
    [0023] FIG. 2A is a cross-sectional side view of a safety IV catheter 40 provided in accordance with one embodiment of the present device and method. The IV catheter 40 is similar to the safety IV catheter 100 of FIG. 2 with some exceptions. Among other things, the interior cavity of catheter hub 104 has been modified to include an enlarged slot or recess 42 immediately distal to guard engagement section 66. This enlarged slot 42 is configured to accommodate arcuate hub engagement section 64 in the shield. of needle 44. As shown, when the needle guard 44 is in the ready position, the guard engagement section 66 is spaced apart from the hub engagement section 64. However, when the needle 202 is moved away from the catheter hub, such as after a successful venipuncture, the needle shield 44 moves relative to the catheter hub such that the hub engagement section 64 abuts or engages the guard engagement section 66 by relative movement. Engagement continues until the needle tip moves proximal to the angled end section of both the first and second arms. At that point, first arm 206 and second arm 208 move radially inward to close over the needle tip. Thus, a feature of the present embodiment is a needle guard having a hub engagement section that is spaced apart from the catheter hub in a ready position and only engages with or abuts the catheter hub after relative movement.
    [0024] If the proximal end of the needle shield 204 is flush with the proximal end 106 of the catheter hub 102, or protrudes outward from the proximal end of the catheter hub 102, the needle hub (not shown) may be mounted on the catheter hub, providing a sleeve on the needle hub to fit over the catheter hub. In an alternative configuration, the needle shield 204 is embedded within the catheter hub and space is provided for a distal end section of the needle hub to fit within the proximal end of the catheter hub.
    [0025] In one embodiment, if molded memory elastomer or non-metallic material without self-bias is used, the arms 206, 208 can be tilted together using any form of tensioning. In other embodiments, a combination of tensioning means and self-biasing non-metallic material is used. As illustrated schematically in FIG. 3A, a tensioning member 218 may be employed in a region of the needle guard 204 between the base portion 205 or proximal wall and the first and second free ends 210 and 212. In one embodiment, the tensioning member 218 may be a hoop made of an elastic material, such as rubber, silicone or similar material, which is made to fit around the first and second arms 206 and 208. The hoop exerts a restoring force on the arms when the arms are separated by the needle 202, as in the ready position. In one embodiment, the tensioning member 218 may be a spring, such as a spiral coil spring, a leaf spring, or other types of spring of similar operation. In one embodiment, tensioning member 218 cannot be a separate component of needle guard 204. In that embodiment, one or both of arms 206 and 208 can be made of a material that exhibits inherent spring properties. The inherent spring properties result in an inherent restorative force being stored in the arms when the arms are separated by needle 202, such as when in the ready position. Once the needle 202 is withdrawn from contact with the first arm 206, the arms naturally return to the protected position. One or more chamfered surfaces 80 and one or more surface features 68, such as recesses or notches, may be incorporated for aesthetic appeal and/or to facilitate greater flexibility to promote installation. In other embodiments, undercuts or other surface features may be added to facilitate assembly of the tensioning member 218. In one embodiment, a coil spring is fitted over the entire needle guard so that the axial force caused by the spring expansion force both arms to move radially and inward.
    [0026] In operation, the distal tip of needle 202 and catheter tube 112 are inserted into a patient's vein to establish venipuncture. Thereafter, the healthcare professional manually removes needle 202 from the catheter hub 102. A male Luer from an IV tube connected to the catheter hub can then be fitted with a source of a fluid that is to be administered into the vein of the patient. patient.
    [0027] While the needle 202 is withdrawn from the patient after successful venipuncture, the needle slides proximally with respect to the catheter tube while maintaining contact with the angled end section 214 of the needle guard to, upon removal, attach the needle guard to the hub. Since the tip of the needle moves proximally from the angled end section 214 of the needle guard, the first arm 206, which is now no longer forced outward by the needle, moves radially inward to separate the engagement section. from hub 64 of shield latch section 66 to cover the needle tip with angled end section 214. Further proximal needle movement causes a profile shift 402 (FIG. 2) located on the needle shaft to confine opening 207 in the proximal wall of the needle guard to stop the relative movement between the needle guard and the needle. At this point, the needle guard may be from the catheter hub due to the abutment between the profile change and the opening in the needle guard. This causes the needle guard to separate from the needle hub to protect the needle tip, which is discussed below.
    [0028] It should be understood that the general configuration and operation of the safety catheter hub 100 thus described provides a context in which the following embodiments of the needle guard can be used to ensure appropriate and adequate protection for healthcare professionals who utilize the safety catheter hub 100. It should further be understood that each of the embodiments described in this text may be used separately or in combination with one another, as appropriate and desired, where functions or characteristics are compatible.
    [0029] Referring again to FIG. 3A, in one embodiment of a needle guard 300, the length of the angled end section 214 may be designated by the variable Ln, where n is an integer, such as 1, 2, 3, and so on. The width (height) of the angled end section 214 can be designated by the variable W, which is most clearly shown in end view 3B-3B. In one embodiment, the length Ln and the width W are selected so that the angled end section 214 is configured to properly lock the needle tip when the needle guard is in the protected position. In a specific embodiment, the length Ln and width W of the needle guard are selected so that the tip is blocked or covered by the angled end section 214, even when the needle is rotated so that the tip of the bevel still faces towards end section 214 or when the needle rotates side-to-side when in the protected position. In addition, the width W and length Ln must be wide enough to prevent the needle bevel from contacting an edge of the angled end section 214, as some plastics, such as polycarbonate or ABS, can chip when hit by the bevel. of the needle. Thus, a feature of the present device, assembly and method is a needle guard having a non-metallic base portion or proximal wall comprising an orifice, a proximally facing surface and a distally facing surface, and in which the The hole and base portion can be distorted by rotating the needle, but where such rotation does not cause the needle tip to escape the confines of an angled distal end section due to the length and width of the angled distal end section. In one example, the length is about the same dimension as the width W for a wide needle guard. In another example, the length is about 1.3 greater than width W, such as 2x, 3x or 4x greater than width W. Compared to needle diameter, width W is preferably 1.25x or even larger than the needle diameter, such as 2.5x, 3x or larger than the needle diameter.
    [0030] In one embodiment, length L1 is selected such that the angled end section 214 protrudes over at least a portion of the second free end 212 when the first and second arms 206 and 208 are in the protected position. Alternatively, length L2 can be selected such that the angled end section 214 protrudes over and between at least a portion of the second free end 212 over the entirety of the second free end 212 when the first and second arms 206 and 208 are in a protected position. In another alternative embodiment, length L2 may be selected such that the angled end section 214 protrudes entirely over and beyond the second free end 212 when the first and second arms 206 and 208 are in the protected position. In this way, for example, the length Ln can be selected to make the angled end section 214 protrude over a fraction of the second free end 212, between more than a fraction of 100% of the second free end 212 or more than 100% of the second free end 212 when the first and second arms 206 and 208 are in the protected position.
    [0031] Similarly, the width W of the angled end section 214 can be selected such that the angled end section 214 is greater in width W than the width of the second free end 212 when the first and second arms 206 and 208 are in the protected position. Thus, for example, the width W can be selected to be greater than the width of the second free end 212 between a fraction about 50% greater than the width of the second free end 212 when the first and second arms 206 and 208 are in the protected position. It should be understood that selection of length Ln and width W can be independent of selection of other dimensions. As shown in FIG. 3B, width W and length Ln are always greater than the outer diameter D of needle 202, so that no matter how the needle is rotated or pivoted in hole 207 during withdrawal, the needle tip and bevel are always blocked by the angled end section 214. Thus, the angled end section 214, when in the protected position, creates a space back there that is defined by a length and width of the angled distal end section 214 greater than the outer diameter D of the needle. In one embodiment, the width is at least 125% larger than the needle diameter and the length is at least 200% larger than the needle diameter. In other embodiments, the width is about 150% to about 300% larger than the needle diameter. The length and width disclosed along with hole 207 at the proximal end are configured to retain the needle tip within open area 304 within the needle guard.
    [0032] To further facilitate needle tip protection, the angled end section 214 of the needle guard may incorporate a shield member or insert 306. The shield member 306 may be made of a puncture resistant material such as a metal insert or a hard plastic insert. The shield member 306 resists puncture of the angled end section 214 by the needle tip once the needle has been captured by the needle shield 300. For example, when the needle shield is made of an elastomeric material, the shield member bulkhead 306 may be incorporated, such as by co-molding or insert molding, to prevent exposure of the needle tip by penetrating through angled end section 214. In another embodiment, bulkhead member 306 is positioned on an outer surface of the angled end section 214, for example, at the distal surface 308 of the proximal surface 310 of the angled end section. The shield member 306 can be mounted to the outer surface using any well-known means of gluing the components, such as by gluing, soldering, and the like.
    [0033] FIG. 3B is a schematic top or plan view of needle guard 300 in a shielded or shielded position, which captures needle tip 196 within open area 304 of the needle guard. While the needle guard 300 is made, at least partially, of a non-metallic material that has less strength and hardness than a metallic material, the needle can pivot through a first angle, as shown by the dashed and dotted line. 30, or along a second angle, as shown by the dashed and dotted line 32. When pivoting, the needle may touch hole 207, points 34 and 36 and/or corresponding points on the distal edge of hole 207 and , possibly compressing or distorting part of the hole for further pivoting. When this happens, the needle tip 196 moves within the confined open space or the needle tip carrier space 304 and may slide past the side edges 38 of the needle guard, near the angled end section 214. However, as discussed above , by selecting an appropriate ratio of width W and length, the needle tip is prevented from slipping past the side edges 38. Alternatively or additionally, the inside diameter of hole 207 can be made to have a snug-fit versus the needle shaft outer diameter to minimize the amount of possible pivoting. Hole length can also be used in combination with hole diameter to minimize the amount of possible pivoting. Even further, a relatively stiffer insert can be incorporated with orifice 207 or within orifice 207 to not only increase the needle separating force, as discussed in more detail below, but also to minimize the amount of possible needle pivoting.
    [0034] FIG. 4A is a side view of a needle guard 400 located over a needle 202 in a guarded position. Needle 202 has a substantially constant cross-section, i.e., a nominal diameter, along the length of the needle, except for a profile change 402 provided near the needle tip at the distal end of needle 202. The profile change may be viewed as a needle section that has a dimension other than the nominal diameter dimension and can be created using various means. In one embodiment, profile change 402 is done by clipping a portion of needle 202, either along both sides, or symmetrically along the circumference of the needle, or, alternatively, only one side or tip on the needle. needle circumference. The stapling method creates a recess along one plane of the needle and a flare along another plane of the needle. Profile change 402 can also be formed by adding material to the outer surface of needle 202 or adding a sleeve to the needle. The added material can include an adhesive, a resin or a metal material. As such, the profile change can be referred to as a snag, which can include a needle section with added material, a clamp, a sleeve, a snag, or combinations of these.
    [0035] As shown in FIGS. 4A and 4B, the position of the profile change 402 formed on the outer surface of the needle 202 is selected such that the profile change 402 faces or comes close to the distally facing side 62 of the base portion 205 of the needle shield. needle 400 at substantially or about the same time or moment when the needle tip moves proximally to the angled end section 214 of the first arm 206. The profile change 402, or at least the widest point of the profile change, is greater than the dimension of the hole 207 of the base portion 205. In this way, the needle tip of the needle 202 is prevented from moving proximally of the base portion 205 due to the relative dimensions of the profile change 402 and the opening. of hole 207.
    [0036] In some embodiments, the pulling force, detachment force or separating force to separate the needle from the needle guard can be increased by incorporating an insert 404 into orifice 207. As shown in FIGS. 4A and 4B, rather than directly facing the material from which the needle guard 400 is made (eg, plastic, elastomer or TPE), the profile change 402 can be made to at least partially touch the insert 404, which can be made of a metal such as a stainless steel sleeve or tube. Metal-to-metal contact between profile change 402 and metal insert 404 increases the pulling force required to pull profile change 402 through hole 207 during use. In another embodiment, instead of a metal insert, the insert may be made of a harder plastic material than the base material used for forming the tip guard. By incorporating a 404 insert into hole 207 of the tip guard 300, the peel force can be increased by at least 100% over an opening made of a plastic, elastomer or TPE material.
    [0037] In one example, a detachment force to separate a needle from a polycarbonate tip guard was found to be approximately 5 Newtons (N). Whereas, with a metallic tip guard, separation is more difficult, and a peel strength of about 20N or more, such as 30N, has been found to be achievable. Thus, a feature of the present device and method is a safety IV catheter comprising a needle hub, a catheter hub and a tip guard made of a first material, which has an insert in line with a proximal opening of the tip guard. made from a second stronger material. In the event that a detachment force to separate the needle from the tip guard is at least 100% greater than a comparable safety IV catheter that has a tip guard made only of the first material. For example, the detachment force can be 200%, 300% or 400% greater than a comparable safety IV catheter that has a tip guard made only of the same material. In a specific example, the detachment force is approximately 600% greater than a comparable safety IV catheter, which has a tip protector made only from the first material. Thus, an opening in the proximal wall or base section 205 of the tip guard can be enlarged more easily by the change of profile located in the needle than for the opening of the insert, which translates to greater peel strength.
    [0038] Accordingly, one aspect of the present safety IV catheter and method is a multi-piece tip protector made of a first material, such as an elastomer or thermoplastic elastomer (TPE) material, located at least partially within a catheter hub. Where an insert comprising an insert hole made of a second material is coupled to a proximal wall of the tip guard to form a multi-piece tip guard and to increase the detachment force of the multi-piece tip guard, and a needle comprising a change in profile compared to similar safety IV catheters where no insert is incorporated. In a particular embodiment, the insert is a metal plate or sheet. Coupling can be mechanical, co-molding or insert molding, or bonding, such as by adhesive or laser. In another embodiment, the insert is a metal sleeve or tube. In yet another embodiment, the insert increases the force required to pivot the needle, unintentionally or otherwise, with respect to a proximal wall hole compared to the same IV catheters without the insert. The insert comprises a hole or an opening that is aligned with the hole or opening of the needle guard. As described above, the insert can be a plate or sleeve and can be co-molded or insert molded with the needle guard or attached to an outer surface of the needle guard.
    [0039] Another aspect of the present device and method is a safety IV catheter comprising a tip guard made of a first material, such as an elastomer or a thermoplastic elastomer (TPE), and having a proximal wall comprising an opening defining a hole and two arms extending distally from the proximal wall with one of the arms comprising an angled end section configured to cover a distal end of the other arm in a shielding position; and where an insert made of a second material comprising an opening is aligned with the opening in the proximal wall. Another feature of the safety IV catheter is a shield member made of a third material, which is different from the first material, coupled to the angled end section. In one example, the second material is the same as the third material. In yet another example, the angled end section is both longer and wider than the distal end of the other arm.
    [0040] Advantageously, the use of the 404 metal insert to increase the pulling force allows a reduction in the size of the 402 profile change. For example, when the profile change is a staple, the clamping length can be reduced when the profile change is pulled against a 205 base portion of a non-metallic needle guard that has a 404 insert. This allows the use of a more conventional catheter tube and adapter sleeve 203 (FIG. 2) used to secure the catheter tube to catheter hub compared to a similar size needle used with a non-metallic needle guard without an insert. In other words, if an insert is not incorporated, a larger clamp may be needed to prevent separation by opening the needle guard, which in turn requires a relatively wider catheter tube to accommodate the larger clamp. Thus, by incorporating an insert, the needle clamp can be made to industry standard without having to over-staple the needle in an attempt to increase the peel force, which requires a corresponding catheter tube and bushing. clamp brackets 203 oversized to accommodate an otherwise enlarged clamp. Furthermore, since the profile change can be made smaller when used with a needle guard with an insert, the internal needle profile to allow for adequate fluid flow, which can decrease due to excessive clipping, can remain relatively great. Similarly, in embodiments where the profile change is done by adding material to the needle, the amount of material added to the needle to create the profile change may also be reduced. Patients can benefit from the current model, which is configured to allow optimal staple size and detachment force without having to oversize the needle and catheter tube, which could lead to more painful venipuncture procedures. Stated differently, the current device and method allows one to use a relatively smaller needle size compared to a safety IV catheter that has a needle that is otherwise excessively stapled to work with a needle guard made of an elastomer or TPE without an insert.
    [0041] Referring again to FIG. 4A, a needle tip carrying space is defined by an area behind the angled end section 214, the free end or cantilever end 212 of the second arm 208, and the stroke length when the needle 202 pivots side-to-side. side to move in and out of the plane defined by FIG. 4A. By sizing the angled end section to an appropriate length and width, the needle tip and needle tip bevel section is retained within the needle tip carrier space 70 regardless of whether the needle pivots or rotates within hole 207 and with or without a 404 insert.
    [0042] FIG. 5 is a side view of a needle guard 500 provided in accordance with another embodiment of the present assembly and method. As shown, first arm 502 and second arm 504 may each be made wholly or partially of a metal material. For example, the first arm 502 of the needle guard 500 may be made of a metal material, but not the second arm, which may be made of a plastic, elastomer, or TPE. First metal arm 502 may be coupled to second arm 504 of needle guard 500 using previously known art means, such as insert molding, soldering or adhesive. In some embodiments, first metal arm 502 is attached to a base portion 506 of needle guard 500. In the embodiment shown, base portion 506 is made of the same material as second arm 504. In other embodiments, the portion base 506 is made of a metallic material. The base portion 506 of the various embodiments includes a hole 207 extending therethrough in the axial direction for receiving the needle 202. The base portion 506, furthermore, has distally facing 62 and proximally 60 facing wall surfaces.
    [0043] In one embodiment, the first arm 502 may be formed of a strip of sheet metal that has spring properties. In that embodiment, the first arm 502 includes a base section 508 and a flexible section 510. The base section 508 is coupled to the base section 506. In one embodiment, the base section 508 of the first arm 502 is located against an outer surface of the portion. base 506. The base section 508 of the first arm 502 can be secured to the base portion 506 using conventional methods, such as by sticking, welding or insert molding.
    [0044] In an alternative embodiment shown in FIG. 6, a proximal face 602 can be created by bending a portion of the base section 508 of the first arm 502 around the base portion 506 of the needle guard to lie against the proximal outer surface 60 of the base portion 506. In this embodiment, bottom face 602 defines a hole which fits concentrically with hole 207 to allow needle 202 to be inserted therethrough. Bottom face 602 is configured to increase the pulling force required to fully extract the profile change 402 through orifice 207 during use, i.e., the pulling force. In another embodiment, the bottom face 602 is insert molded for the needle guard and is positioned within the base portion 506 or on the distal wall surface of the base portion. Optionally, base portion 506 also includes an insert 404 in addition to bottom face 602.
    [0045] Referring again to FIG. 5, the flexible section 510 of the first arm 502 includes a distal angled end section 512. The distal angled end section 512 is angled inwardly toward the second arm 504. The angled end section 512 may have a length that extends over, at least a fraction of one percent to greater than 100% of the second arm 504. In one embodiment, the angled end section 512 may generally have a V-shape, with the peak of the V pointing in the axial and axial direction. free leg of V extending toward second arm 504.
    [0046] In one embodiment, one or more rod members 514 may be added to the first arm 502. The rod members 514 are provided on the first arm 502 to add strength to the arm. To provide additional strength, rod members 514 may extend axially along the entire length of first arm 502 or may extend only along a portion of first arm 502. For example, a rod member 514 may extend substantially along only the axial extent of flex section 510. When flex section 510 of first arm 502 is angled away from second arm 504, rod member 514a increases the amount of resistance with which the first arm resists. to the slope. In this way, when the tilt is removed, the bendable section 510 of the first arm 502 is more quickly and reliably moved back into the protected position. Furthermore, once in the protected position, the stiffening of the first arm 502 by the rod member 514a makes it more difficult to inadvertently flex the bendable section 510 of the first arm 502.
    [0047] In one embodiment the needle guard 500 may include a flap or a pair of flaps 516. The flaps 516 may be included as an extension of the first arm 502, which is flexed 90 degrees or more towards the open area 520. The flaps 516 extend from the first arm 502 to an open area 520 defined in the open space between the first arm 502 and the second arm 504. In this way, the flaps 516 provide a semi-closure for the open area 520, which helps to keep the needle tip confined behind the angled end section 512.
    [0048] Alternatively, or in addition to this, tabs 522 can be positioned on angled end section 512. Tabs 522 can be made as extensions of a top and bottom surface of angled end section 512. Tabs 516 and 522 can be integrally formed with the corresponding first arm 502 and with the angled end section 512. The tabs can also later be attached to the corresponding first arm 502 and the angled end section 512, such as by the use of an adhesive, by welding of the tabs therein or using other equally suitable methods of attachment known in the art.
    [0049] In embodiments in which the second arm 504 is made of a non-metal, metal or non-metal tabs 524 may be added to the second arm. Tabs 524 can be added using adhesives or other equally suitable bonding methods known in the art. The second arm can be made completely or partially of metal.
    [0050] In each embodiment, tabs 516, 522 and 524 are sized such that the needle tip is blocked from exiting the open area 520 when the first and second arms 502 and 504 are in the protected position. For example, tabs 516 and 524 may extend from each arm into open area 520 for a distance to or beyond the axial centerline of needle guard 500. In another example, tabs 522 may extend from the angled end section 512 into open area 520 by a distance that causes tabs 522 to protrude beyond a portion of needle 202.
    [0051] The above description presents the best considered way to establish a needle safety device and associated methods and the manner and method of making and using them in such complete, clear, concise and exact terms, of way to enable anyone versed in the art to which it belongs to make and use this device. This apparatus, however, is likely to undergo modifications and alternative constructions in relation to those discussed above and which are completely equivalent. Accordingly, such apparatus is not limited to the specific embodiments disclosed, and certain features disclosed for one embodiment may be incorporated in another embodiment, as long as their functions are compatible. On the contrary, this apparatus encompasses all modifications and alternative constructions which fall within the spirit and scope of the apparatus as generally expressed by the following claims, which particularly point out and distinctly claim the subject and purpose of the apparatus. Furthermore, the embodiments illustratively disclosed in this patent application may be properly practiced in the absence of any element that is not specifically disclosed in this text.
    权利要求:
    Claims (13)
    [0001]
    1. Needle assembly, comprising: a needle guard (300) having a non-metallic base portion (205) comprising a wall having a hole (207), a hole length, a hole diameter, an orifice facing surface. proximal mode (60) and a distally facing surface (62); a first arm (206) including a first free end (210) and a second arm (208) including a second free end (212), the first and second arms (206, 208) extending generally axially in a distal direction. from the non-metallic base portion, the first free end (210) extending beyond the second free end (212) and including an angled end section (214) extending toward the second arm (208), the section an angled end (214) comprising a first side edge and a second side edge defining a length and a width; an open area, an open space or a needle tip housing space (304) defined at least in part by the non-metallic base portion (205), the first arm (206), the second arm (208), and by the angled end section (214); and a needle (202) having a needle tip (196), a profile change (402) and a needle shaft having a needle diameter; wherein the first arm (206) and the second arm (208) are urged to move between a ready position in which the angled end section (214) abuts the needle (202) and a shielded position. , in which the needle tip (196) is confined within the open area, the open space or the needle tip housing space (304); characterized in that the length (Ln) and width (W) of the angled end section (214) are greater than the needle diameter and sized so as to confine the needle tip (196) within the open area of the open space or the needle tip housing space (304) in the protected position, as the needle guard (204) rotates or rotates and pivots; wherein the width (W) of the angled end section (214) is at least 4.25 times greater than the needle diameter; and the length (Ln) of the angled end section (214) protrudes over a fraction of the second free end (212) between 40% and 100% in the shielded position.
    [0002]
    2. Needle assembly according to claim 1, characterized in that the width (W) of the angled end section (214) is at least 1.25 times, preferably 1.5, greater than the width of the second free end (212).
    [0003]
    3. Needle assembly according to claim 1, characterized in that the length and width of the angled end section (214), the hole length and the hole diameter of the non-metallic base portion cooperate to prevent the needle tip (196) to move beyond the first side edge or the second side edge.
    [0004]
    4. Needle assembly according to claim 1, characterized in that it further comprises an insert (404) made of a metallic material.
    [0005]
    5. Needle assembly according to claim 4, characterized in that the insert is made of a material harder than the non-metallic base portion to minimize the pivoting of the needle.
    [0006]
    6. Needle assembly according to claim 3, characterized in that the insert (404) is a metallic plate comprising an opening fixed to the non-metallic base portion.
    [0007]
    7. Needle set, according to claim 4, characterized in that the profile change (402) is in contiguity with the insert (404), when the needle set is in the protected position.
    [0008]
    8. Method for assembling a needle assembly defined in any one of claims 1 to 7, characterized in that it comprises: providing the needle (202) having the profile change (402) close to the needle tip (196) in a needle cube; placing the needle guard (204, 44) slidably relative to the needle shaft; and moving the needle guard (300) to a proximal position on the needle shaft so that the angled end section (214) is pushed by the needle shaft and spaced from the needle tip (196).
    [0009]
    9. Method according to claim 8, characterized in that it comprises placing the needle shield (300), at least in part, within an interior cavity of a catheter hub (102) having a tube of catheter (112) attached to it.
    [0010]
    10. Method according to claim 8, characterized in that it comprises placing the needle shield (204, 44), at least in part, within an interior cavity of a catheter hub (102) having a catheter tube (112) attached thereto, wherein the catheter hub (102) incorporates a needle shield engagement section (66) and the needle shield contains a hub engagement section (64).
    [0011]
    11. Method according to claim 10, characterized in that the hub of the catheter (102) incorporates both a recess and a projection for engaging with the hub engagement section (64) of the needle guard (204) at a ready position, and placing the needle shield (204) at least in part into an interior cavity of the catheter hub (102) comprises placing the needle shield within the catheter hub (102) at least until the catheter hub projection engages the hub engagement section (64).
    [0012]
    12. Method according to claim 10, characterized in that placing the needle shield (204), at least in part, within an interior cavity of the catheter hub (102) comprises placing the needle shield (204 ) within the catheter hub (102) at least until the projection of the catheter hub (102) engages with the hub engagement section (64) circumferentially around the needle shield (204).
    [0013]
    13. Method according to claim 10, characterized in that the needle shaft comprises a profile change (402) to engage the metal plate.
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    同族专利:
    公开号 | 公开日
    EP3058976A1|2016-08-24|
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    CN103269739A|2013-08-28|
    EP3878496A1|2021-09-15|
    RU2020123566A|2022-01-18|
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    US10661058B2|2020-05-26|
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    RU2020123569A|2022-01-17|
    RU2016101256A|2018-11-21|
    PL2600925T3|2021-12-06|
    ZA201300873B|2014-04-30|
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    PT2600925T|2021-08-24|
    DK2600925T3|2021-08-16|
    RU2729036C2|2020-08-03|
    RU2020123569A3|2022-01-17|
    EP2600925A1|2013-06-12|
    RU2013109410A|2014-09-10|
    US20190366053A1|2019-12-05|
    RU2020123566A3|2022-01-18|
    MY163592A|2017-09-29|
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    CO6680648A2|2013-05-31|
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    EP3967344A1|2022-03-16|
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    WO2012016660A1|2012-02-09|
    DE11736297T1|2014-03-06|
    CN106943647A|2017-07-14|
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    法律状态:
    2017-04-11| B15I| Others concerning applications: loss of priority|Free format text: PERDA DA PRIORIDADE US 61/371.054 DE 05/08/2010, CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 167O E NO ART. 29 DA RESOLUCAO INPI-PR 77/2013, POR NAO ATENDER AO DISPOSTO NO ART. 28 DA RESOLUCAO INPI-PR 77/2013, POIS NAO FOI APRESENTADA CESSAO DA REFERIDA PRIORIDADE, QUE POSSUI DEPOSITANTE DIFERENTE DO DEPOSITANTE DA FASE NACIONAL. |
    2017-05-30| B12F| Other appeals [chapter 12.6 patent gazette]|
    2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-08-04| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-02-09| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2021-06-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-09-14| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 26/07/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |
    优先权:
    申请号 | 申请日 | 专利标题
    US37105410P| true| 2010-08-05|2010-08-05|
    US61/371,054|2010-08-05|
    PCT/EP2011/003746|WO2012016660A1|2010-08-05|2011-07-26|Needle safety device and assembly|
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