HK1139880B - Catheter assembly and components thereof - Google Patents

Description

Catheter assembly and components thereof

Catheter assemblies are generally discussed herein, and in particular extend to discussions of catheter assemblies having a tip protector, a valve opener, and optionally a needle wiper.

Background

The insertion procedure for an IV (intravenous) catheter assembly comprises four basic steps: (1) the healthcare worker inserts the needle and catheter together into the patient's vein; (2) after inserting the needle tip into the vein, the healthcare worker advances the catheter into the patient's vein by pushing the catheter with his or her finger; (3) the health care provider withdraws the needle by grasping the end of the hub (hub) (opposite the needle tip end) while applying pressure with his or her free hand to the patient's skin at the insertion site to prevent blood flow through the catheter; and (4) the health care provider then taped the exposed end of the catheter (the catheter hub) to the patient's skin and connected it to a source of fluid to be infused into the patient's vein.

The problem is that immediately after withdrawing the needle from the patient's vein, the healthcare worker (which is now associated with at least two urgent procedures) must place the exposed needle tip in a nearby location and process the tasks required to withdraw the needle. It is at this time that the exposed needle tip poses a risk of accidental needle sticks, which in this case leaves the healthcare worker vulnerable to the transmission of various dangerous blood-borne pathogens, including AIDS and hepatitis.

Other needle types similarly expose healthcare workers to the risk of accidental needle sticks. For example, a physician administering an injection using a straight needle, a Huber needle, a epidural needle, or the like, may place the used needle on a tray for subsequent disposal by a nurse. The time between placing the used needles on the tray or table and discarding the used needles is a potential source of disease transmission for those working near or around the needles.

Therefore, all needles must be covered immediately after use to ensure better personnel safety. Ideally, the procedure for covering the needle tip must be passive, self-activating, or at least easy to perform. Furthermore, the means for covering the needle must be reliable and robust.

More advantageously, a valve should be incorporated into the catheter assembly to minimize blood exposure after successful catheter insertion. In addition, since blood comes into contact with and deposits on the needle, the needle assembly should further incorporate a mechanism for wiping the needle with the deposited blood when the needle is withdrawn.

SUMMARY

According to aspects of the present invention, there is provided a catheter assembly, including: a first hub comprising a housing including an outer surface and an inner surface defining an interior cavity; a tube attached to the first hub and extending distally of the first hub; a second hub comprising a housing comprising an outer surface and an inner surface defining an interior cavity; a needle having a needle tip attached to the second hub and projecting distally of the second hub and into the tube; a valve including a top surface, a rim depending therefrom, and an opening in the top surface through which the needle projects; a valve opener including an actuating end, at least one leg extending proximally from the actuating end; and a wiper including a perimeter defining an opening and with which the needle is in contact for wiping the needle as it is pulled back away from the tube.

Other aspects of the invention include a catheter assembly comprising: a) a catheter hub comprising a housing comprising an outer surface and an inner surface defining an interior cavity; b) a catheter tube attached to the catheter hub and extending distally of the catheter hub; c) a needle hub including a housing; d) a needle having a needle tip attached to the needle hub and projecting distally of the needle hub and into the catheter tube; e) a valve disposed in the interior cavity of the catheter hub for limiting backflow of blood; f) a valve opener disposed on a proximal side of the valve for opening the valve; and g) a tip protector for blocking the needle tip arranged adjacent the valve opener, wherein the tip protector comprises: (1) a tip protector housing having an inner surface; (2) a first arm extending from a distal wall of the tip protector housing biased toward an inner surface of the catheter hub; (3) a second arm extending from the proximal wall of the tip protector housing biased toward the inner surface of the catheter hub; and (4) a third arm extending from the proximal wall of the tip protector housing, biased against a side of the needle.

According to other aspects of the present invention, there is provided a catheter assembly comprising: a catheter hub comprising a housing defining an interior cavity and having a catheter tube extending distally thereof; a needle hub including a housing defining an interior cavity and having a needle with a needle tip extending distally thereof; the needle projects into the catheter body; a hemostasis valve having an opening disposed within the interior cavity of the catheter hub; a valve opener disposed adjacent the hemostasis valve and including an actuation end including a tapered portion and a pair of legs defining a gap extending proximally thereof; a wiper for passing the needle therethrough to wipe the needle as it is withdrawn from the catheter tube; and wherein a tip protector comprising an arm and a wall, the wall comprising an opening, the tip protector being arranged in a gap defined by two legs.

According to still other aspects of the invention, alignment of a pair of legs on the valve opener with the catheter hub is provided by forming two axially extending undercuts in an inner wall surface of the catheter hub for cooperation with the two legs.

In a preferred embodiment of the invention, a raised bump or protrusion is formed within the interior cavity of the catheter hub to retain the tip protector within the catheter hub during retraction of the needle hub away from the catheter hub.

In other aspects of the invention, a wiper in the form of an O-ring is used to wipe blood deposits from the needle.

Other aspects and features of the catheter assemblies provided herein will be better understood and appreciated with reference to the specification, claims, and drawings.

Brief Description of Drawings

The drawings comprise:

FIG. 1 is a cross-sectional side view of a catheter assembly provided in accordance with aspects of the present invention;

FIG. 2 is a cross-sectional side view of the catheter of FIG. 1 with the needle and needle hub removed therefrom;

FIG. 3 is a partial cross-sectional side view of a safety catheter assembly including a valve, a valve opener and a tip protector provided in accordance with aspects of the present invention;

FIG. 4 is a partial cross-sectional side view of the safety catheter assembly of FIG. 3 with the needle hub, needle and tip protector removed therefrom;

FIG. 5A is a cross-sectional side view of the catheter assembly of FIG. 4 with the IV set luer connector coupled to the catheter hub and the valve opener pushed distally into the valve;

fig. 5B is a cross-sectional side view of an alternative catheter assembly similar to that of fig. 3-5A wherein the valve opener does not incorporate barbs to allow disengagement with the valve upon withdrawal of the IV set luer connector.

FIG. 6 is a cross-sectional side view of the needle hub and needle with the tip protector covering the needle tip;

FIG. 7 is a perspective view of the tip protector of FIG. 6;

FIG. 8A is a top view of a wiper including two cut-outs provided in accordance with aspects of the present invention;

FIG. 8B is a perspective view of a valve opener provided in accordance with aspects of the present invention having a wiper in accordance with FIG. 8A attached to a proximally facing attachment surface;

FIG. 8C is a cross-sectional side view of a catheter assembly having the valve opener of FIG. 8B including a wiper disposed inside a catheter hub provided in accordance with aspects of the present invention;

FIG. 9A is a top view of a first alternative wiper provided in accordance with aspects of the present invention;

FIG. 9B is a top view of a second alternative wiper provided in accordance with aspects of the present invention;

FIG. 9C is a top view of a third alternative wiper provided in accordance with aspects of the present invention;

FIG. 9D is a cross-sectional side view of a catheter assembly having a wiper disposed distal of a valve and valve opener provided in accordance with aspects of the present invention;

FIG. 10A is a perspective view of a needle being projected by a valve opener having a wiper attached thereto for wiping the needle;

FIG. 10B is a partial perspective view and a cross-sectional view of the valve opener of FIG. 10A;

FIG. 11 is a partial perspective and sectional view of an alternative valve opener having a needle and O-ring like wiper passing therethrough;

FIG. 12 is a partial perspective and sectional view of an alternative valve opener having a needle therethrough and a wiper aligned with the annular groove;

FIG. 13 is a cross-sectional side view of yet another alternative catheter assembly provided in accordance with aspects of the present invention that includes a third housing disposed between the catheter and the needle hub; and

fig. 14 is a cross-sectional side view of the catheter assembly of fig. 13 taken along an orthogonal plane.

Detailed Description

The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of a catheter assembly for use with a valve and tip protector provided in accordance with aspects of the present invention and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the features and steps for constructing and using the catheter assembly of the present invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures that may be accomplished by different embodiments are also intended to be encompassed within the spirit and scope of the invention, especially those that incorporate combinations of features shown in the different embodiments that are encompassed herein. As indicated elsewhere herein, the same element numbers are intended to indicate the same or similar elements or features.

Referring now to FIG. 1, a partial cross-sectional side view of a catheter assembly provided in accordance with aspects of the present invention is shown and generally designated 10. The catheter assembly 10 includes a catheter tube 12 attached to a catheter hub 14 having a needle 16, the needle 16 attached to a needle hub 18, and the needle 16 protruding through the catheter tube 12 in a ready-to-use position. The needle 16 has a sharpened tip 72 and a crimp, bump or clip engagement (clip engage) portion 73. Catheter hub 14 includes an outer surface 20 and an inner surface defining an interior cavity. Needle hub nose portion 26 preferably projects into the interior cavity of catheter hub 14 and engages in a combination recess and projection (not shown) between catheter hub 14 and needle hub 18 to fix relative angular rotation therebetween.

In an exemplary embodiment, a pair of diametrically opposed grooves 28 are formed in the inner wall surface 22 of the catheter hub 14. The grooves 28 are formed as recesses in the inner wall surface 22 of the catheter hub and each have a length measured from about 20% to about 85% of the length of the catheter hub measured from the proximal threads 30 to the distal shoulder 32 adjacent the frusto-conical nose portion 34. The groove 28 may be formed by known injection molding techniques.

In an exemplary embodiment, a pair of projections 36 are incorporated into the interior cavity 24 of catheter hub 14. The two projections 36 are preferably symmetrical about the central axis of the catheter hub 14 and each include two ends 38 that contact the two grooves 28. In an alternative embodiment, the two ends 38 may be spaced from the two grooves 28, and each projection 36 may be a notch rather than a raised projection. Thus, in a preferred embodiment, the interior cavity 24 of the catheter hub has a diameter, measured from one projection to the other projection (referred to as the projection diameter) at the two projections or projections 36 that is less than the diameter of the interior cavity of the catheter hub 14, measured from a point 40 adjacent the two projections (referred to as the aperture diameter). Also at the two projections or bosses 36, the interior cavity 24 of the catheter hub 14 has a diameter measured from one groove 28 to the other groove 28 (referred to as the average groove diameter) that is greater than the boss diameter and the bore diameter 40.

Fig. 2 is a cross-sectional side view of catheter hub 14 of fig. 1 taken along a transverse plane with needle 16 and needle hub 18 removed therefrom. While the relative position of the groove 28 to the hub 14 and the relative position of the projection 36 to the groove 28 are shown, they may each be varied proximally toward the proximal opening 42, distally toward the nose portion 34 and relative to each other, or may be rotated relative to the needle bevel without departing from the spirit and scope of the present invention.

Referring now to FIG. 3, a partial cross-sectional side view of a safety IV catheter assembly, generally designated 44, provided in accordance with aspects of the present invention is shown. In one exemplary embodiment, the catheter assembly 44 includes a hemostasis valve 46, a valve opener 48, and a tip protector 50 disposed inside the internal cavity 24 of the catheter hub 14 of fig. 1. The tip protector 50 may be identical to one of many tip protectors shown and described in U.S. Pat. No.6,616,630 to Woehr et al, the contents of which are expressly incorporated herein by reference in a manner similar to that set forth in its entirety. The tip protector 50 is housed within the internal cavity 24 by moving the tip protector distally in the direction of the needle tip 72 until the elbow portions 74 (only one shown) between the two arms 76 and two fingers or distal walls 78 (only one shown) are moved distally of the ledge 36 inside the catheter hub. Alternatively, two recesses may be incorporated in place of two protrusions to interact with the two elbow portions 74.

The hemostasis valve 46 can be made of a thermoplastic elastomer (TPE), such as polyisoprene or silicone rubber, and the hemostasis valve 46 generally includes a rim portion 52 and a top portion 54, the top portion 54 having a slit 56 that includes a plurality of slits (e.g., three slits similar to a triangular star or a single slit) to expand the slit as it deflects. The hemostatic valve 46 is commonly commercially available and is a well known component in the relevant art. In accordance with aspects of the present invention, a plurality of protrusions, elongated ridges or protuberances may be incorporated around the outer periphery of rim portion 52 to ensure adequate air flow between valve rim 52 and catheter hub inner surface 22 for flashback purposes. In other aspects of the invention, the cutout 56 is provided with sufficient clearance to allow air movement for the purpose of flashback. In the latter alternative embodiment, there is preferably a hermetic seal between the outer edge portion and the inner surface 22 of the catheter hub.

The valve opener 48 includes an actuating end 58 and a pair of legs 60. In one exemplary embodiment, the actuation end 58 includes a frustoconical distal end configured to project against the top 54 of the valve 46, as further described below with reference to fig. 5. In accordance with aspects of the present invention, the actuation end 58 includes one or more undulating surfaces or barbs 62 for mating engagement with the notches 56 and the plurality of slits on the hemostasis valve.

In one exemplary embodiment, the valve opener 48 is formed of a hard plastic material, which may be a polycarbonate material, a polyoxomethylene (polyoxomethylene) material, or the like. The two legs 60 are formed such that they are spread radially outward with respect to the needle shaft 16. In one particular aspect of the invention, the two legs 60 are aligned with and aligned with the two slots 28. The length and geometry of the valve opener 48 is such that the nose portion 58 abuts the edge portion 52 of the valve 46 and such that the valve exerts a reaction force that pushes the two proximal ends 64 of the two legs 60 against the proximal flange 66 of each respective slot 28 (see, e.g., fig. 9D). The rim portion 52 is thus in a slightly compressed state caused by the nose portion 58 of the valve opener 48 pushing against the rim portion. Alternatively, in the ready-to-use position, the nose portion 58 may be spaced from the valve 46 and not contact the valve 46 (fig. 3).

The two legs 60 are preferably aligned with the two slots 28 without radial compression. In other words, the most radial end 68 of each leg 60 is not biased against the wall surface 70 of the corresponding slot 28. However, slight radial compression may be practiced without departing from the spirit and scope of the present invention.

Referring now to fig. 4, the safety IV catheter assembly of fig. 3 is shown with the needle 16, tip protector 50 and needle hub 18 removed. In practice, this represents the position of the catheter after a successful catheterization. As disclosed in the Woehr et al' 630 patent, when the needle 16 is withdrawn after catheter insertion, the tip protector 50 is withdrawn with the needle and remains with the needle to block the needle tip 72. In certain aspects of the invention, a crimp, projection or clip engaging portion 73 is used to engage an opening in the tip protector 50 to secure the tip protector to the needle. U.S. patent application Ser. No.11/496,769, entitled Needle Assembly and Componentments Thereof, to Kevin Woehr, discloses a tip protector including a sidewall for surrounding a Needle tip that may be used with a catheter Assembly provided in accordance with aspects of the present invention. The contents of the' 769 application are expressly incorporated herein by reference. In other aspects of the invention, the tip protector 50 incorporates a flip to grip the opening of the needle. Exemplary tip protectors that are turned over to grip the Needle are disclosed in U.S. patent No.6,709,419 to Kevin Woehr, patent application entitled Protective Needle Clips by Pat lattana, serial No.10/677,810, and patent application entitled Protective Clips by Matthew Kohler, serial No.10/954,041. The contents of each of the above references are expressly incorporated herein by reference.

As shown in fig. 4, when the top portion 54 of the valve 46 is no longer deflected by the needle, it retracts and the slit 56 closes to form a seal. Thus, the flow of blood in the direction from the catheter tube 12 is stopped. Although not depicted, the outer periphery of the valve 46 is tucked into the internal cavity and the valve is under compression caused by the interference fit. When blood flow has ceased, the health care provider may connect the IV set luer connector to catheter hub 14 leisurely, tape-secure the catheter hub to the patient, and dispose of the used needle without leaking too much blood through the catheter hub. Alternatively, the valve may provide a semi-permeable seal that gives the healthcare worker sufficient time to make the required connections, fixings and handling of the used needle before blood will exit catheter hub 14 at proximal end 42.

Assuming that the opening 42 of the hub 14 defines a plane 83, in one exemplary embodiment, the end surfaces 80 of the two legs 60 at the two proximal ends 64 are positioned at an angle to the plane 83. The two legs 60 should also project radially inward toward the nominal inner diameter (i.e., bore diameter 40) of the catheter hub 14 at a location just proximal to the two proximal ends 64. As discussed further below with reference to fig. 5, the projection provides a contact surface on each proximal end 64 of the valve opener 48 to be pushed by the IV set Luer connector. In an alternative embodiment, the end surface is generally parallel to the plane 83 defined by the opening 42.

Fig. 5A depicts the IV set Luer connector 86 being pushed into the opening 42 of the catheter hub 14. When the connector 86 is pushed forward distally, its distal end 88 abuts both end faces 80 of the seal opener 48 and advances the opener 48 forward distally. The opener 48 in turn moves into the sealed top area 54 and forces the slits 56 to deflect. The combined friction and barbs 62 on the actuating end 58 of the valve opener 48 allow the valve opener 48 and the actuating end 58 to remain engaged. The valve 46 remains open and fluid communication is provided between the catheter tube 12 and the interior cavity 24 of the catheter hub 14. Medication, IV solution, or other fluid may now be introduced through connector 86 and catheter 12. If the IV set luer connector 86 is subsequently withdrawn from the catheter hub 14, the valve 46 will remain open and thus there may be a blood leak. Alternatively, the actuation end 58 does not incorporate the barb 62 as shown in FIG. 5B, thereby allowing the valve top portion 54 to separate from the actuation end 58. This allows the valve opener 48 to move proximally by action of the resilient top portion, while allowing the incision to reseal itself.

Fig. 6 is a cross-sectional side view of needle hub 90, which needle hub 90 has a needle 92 attached at its end and a tip protector 94 covering a needle tip 96. As is known in the art, a flashback plug (not shown) is typically placed in the proximal end of the needle hub 90. Tip protector 94 is as shown and described in application serial No.11/496,769, which was previously incorporated herein by reference. As disclosed in the' 769 application, the tip protector 94 includes a first protector body 98 surrounded by a second protector body 100. The first protector body includes a short arm 102 and a long arm 104, both of which have portions that extend at least partially to one side of the centerline of the needle 92. The second protector body 100 (fig. 7) partially encloses the first protector body and includes a deflector plate 106, a front wall 108 having an opening 110, and two side walls 112 (only one shown). When the tip protector 94 is in the protective position over the needle tip (fig. 6), the needle tip is surrounded by a plurality of walls.

In one exemplary embodiment, the combination needle hub 90, needle 92 and tip protector 94 of fig. 6 may be used with the catheter shown in fig. 4. The projection 36 on the hub 14 will be disposed proximally relative to the apex 115 of the long arm 104 of the tip protector 94 to retain the tip protector 94 in the catheter hub 14. Alternatively, the tab 36 may be omitted and the arm 102 and deflector plate 106 resiliently engage the inner wall surface 22 to retain the tip protector 94 to the catheter hub.

Generally, when the needle is withdrawn from the catheter tube after a successful catheterization, residual blood may be deposited on the needle shaft. The visibility and presence of blood on the withdrawn needle is undesirable and may be contagious. Thus, in accordance with aspects of the present invention, a wiper is provided to wipe the needle as it is withdrawn from the catheter. Fig. 8A, 9B, and 9C are top views of four different wipers 176, 116, 118, and 120 provided according to aspects of the present invention. As discussed further below with reference to fig. 8B and 9D, the wiper is configured to attach to a valve opener or catheter hub to scrape or wipe fluid from the surface of the needle as it is withdrawn from the catheter tube.

Fig. 8A shows a wiper 176 made from a liquid impermeable film (e.g., a blown PE film) that includes a generally circular configuration with two cuts 178. The cutout 178 is sized and shaped to allow fitting over the valve opener, and the cutout 178 is incorporated along the perimeter of the wiper. Thus, the shape of the cut-out and the overall configuration of the wiper may vary depending on the mounting surface of the valve opener. In one exemplary embodiment, wiper 176 has a solid central portion (i.e., no central opening) configured for being pierced by a needle during assembly, as discussed further below.

8B is a perspective view of a valve opener 180 provided according to aspects of the present invention. In one exemplary embodiment, the valve opener includes an actuation end 182 and two legs 184 connected to and extending proximally of the actuation end. Like valve opener 48 shown in fig. 3, actuation end 182 includes a frustoconical configuration and incorporates barbs (not shown in fig. 8B) and a channel for receiving a needle. In a particular aspect of the invention, the channel is funnel-shaped in shape. Although the two legs 184 are shown extending parallel to and offset from the axis defined by the center of the channel, the two legs 184 may be angled radially outward as they extend proximally. The two legs may also incorporate a slight arc or bend, such as that shown in fig. 3.

In one exemplary embodiment, a proximally facing wall surface 186 on the actuation end is provided and serves as a mounting surface for the wiper. The wiper 176 of fig. 8A may be attached to a mounting surface 186 with the cut-outs 178 aligned with the two legs 184. The wiper may be soldered to the mounting surface or adhered to the mounting surface with a suitable adhesive, such as a cyanoacrylate or UV curable adhesive. In practice, the valve opener 180 and wiper 176 may be mounted as shown in fig. 8C, and when the needle 16 is inserted, the needle tip 72 penetrates the wiper, and the wiper then provides a wiping function for the needle. When the wiper 176 is penetrated by the needle tip 72, the needle 16 will cause the wiper to open and expand, placing the needle in close contact relationship with the wiper 176. Thus, when the upstream portion 146 of the needle 16 (i.e., upstream of the wiper) is exposed to blood from the flashback and then withdrawn proximally (i.e., to the right of fig. 8C) to remove the needle 16, the close contacting relationship between the wiper 176 and the needle 16 allows the wiper to wipe blood deposits from the needle as it is withdrawn. Thus, when the needle is fully withdrawn from the valve opener, the needle will appear clean or at least visually invisible for the most part, and the tip protector surrounding the needle tip will likely remain visually invisible.

Fig. 9A shows a wiper 116 having a generally circular configuration (which may be a microporous plastic film filter) of a first wiper material 122 surrounding an inner layer 124 of plastic (e.g., a Polyethylene (PE) blown film layer). The outer wiper material 122 is preferably air permeable to allow for flashback. The film may be made of PP (polypropylene) or PA (polyamide or polyamide)) Spun bond fibers (spun bond field), such as those known in the art from blood flashback plugs.In a preferred embodiment, inner layer 124 is a plastic film configured for being pierced by a needle when the combined needle hub and needle are assembled on a catheter hub (such as the one shown in fig. 3 with a wiper attached to the valve opener). The wiper should be thin enough so as not to damage the needle tip as it passes therethrough. The inner and outer layers may be welded to each other.

In one exemplary embodiment, the wiper 118 shown in FIG. 9B is the same as the wiper 116 shown in FIG. 9A, except for the pre-formed openings 126. The opening 126 is preferably sized to be the same as the needle diameter. In other words, the opening is sized to have zero clearance around the outer diameter of the needle. More preferably, the opening 126 is sized to be the same as the inner diameter of the catheter tip, which is slightly smaller than the outer diameter of the needle.

FIG. 9C illustrates yet another wiper embodiment 120 provided in accordance with aspects of the present invention. In one exemplary embodiment, the wiper includes a single film layer 128 having an opening 126 that has the same diameter size as the inner diameter of the catheter tip. A plurality of micro-holes are formed in the film layer 128 to facilitate venting. The pores are each sized from about 3 μm (microns) to about 8 μm. The film can be made of PE or spunbond PA or PP.

FIG. 9D is a cross-sectional side view of an alternative safety IV catheter assembly, generally designated 188, provided in accordance with aspects of the present invention. Catheter assembly 188 is similar to catheter assembly 44 of fig. 3 and includes catheter tube 12 and hub 14, needle 16 and needle hub 18, tip protector 50, valve opener 48, and valve 46. However, in an alternative safety IV catheter assembly 188, an air permeable and fluid impermeable wiper 190 is incorporated distal to the valve 46. In an exemplary embodiment, the wiper 190 may be one of the wipers 116, 118 or 120 shown in fig. 9A, 9B or 9C and may be attached to the tube hub 192 to retain the catheter tube 12 to the catheter hub 14. The tube bushing 192 is preferably made of a thermoplastic material to facilitate attachment of the wiper 90 thereto, such as by bonding or welding. In an alternative embodiment (not shown), a shoulder or seat may be provided within the interior cavity of catheter hub 14 to accommodate wiper 190.

Fig. 10A is a partial perspective view of the needle 130 protruding through the valve opener 132 (with the wiper 134 attached thereto). The valve opener 132 is similar to the valve opener shown and described with reference to fig. 3-5. Fig. 10A and 10B-12, discussed further below, may be considered a safety catheter assembly, such as the assembly of fig. 3, without showing the catheter hub, needle hub, or tip protector for clarity and for purposes of discussing only the function of the wiper. It will therefore be appreciated that the components shown in fig. 10A, as well as those of fig. 10B-12, are suitable for use with catheter hubs, needle hubs and tip protectors in the same manner as those described with reference to fig. 1-5. Further, the tip protector is not limited to those shown, but also includes those expressly incorporated herein by reference.

In an exemplary embodiment, the valve opener 132 includes two legs 136 extending proximally of a frustoconical actuation end 138. Although not shown, the actuation end 138 may include undulating surfaces or barbs for gripping engagement with the hemostasis valve. The actuation end 138 includes a generally planar, proximally facing surface 140 and a channel or lumen 142 for receiving the needle 130. The two legs are radially spaced from the needle 130 with a gap 143 therebetween to accommodate the tip protector.

Fig. 10B is a partial perspective partial cross-sectional rotated and enlarged view of the valve opener 132 of fig. 10A. The valve opener is shown with a wiper 134 having a ring or cylinder in a recessed portion of the actuation end 138. The wiper 134 may be insert-molded in the opener 132. The tab 144 is the material that remains between the wiping ring and the chamber door. Alternatively, the wiper may be integral with the actuation end 138. The wiper 134 includes a channel 152 having a first diameter slightly larger than the outer diameter of the needle 130, and a lip 154 having a second diameter, preferably sized to the inner diameter of the catheter tip of the catheter tube in which the needle 130 is configured to be disposed. As discussed above with reference to fig. 8C and 9D, as the needle 130 is withdrawn proximally, blood deposits along the upstream end (distal) 146 of the needle are wiped away by the wiper 150.

Fig. 10B shows the valve opener 132 with a single leg 136. However, a valve opener with two legs with a gap between them is more preferred. The gap between the two legs 136 is configured to receive the tip protector 50, such as shown in fig. 3 and 9D.

Fig. 11 is a partial perspective partial cross-sectional side view of an alternative valve opener 156 provided in accordance with aspects of the present invention. The valve opener 156 is shown with the needle 130 protruding through the actuation end 138. In the embodiment shown, a well or recessed area 158 is incorporated to accommodate a wiper in the form of an O-ring 160, which O-ring 160 may be made of an elastomeric or TPE material. An O-ring 160 may be slid into the well 158 and a retaining ring 162 urged against the O-ring to retain the O-ring therein. The retaining ring 162 is secured to the well 158 using a simple interference fit. In an alternative embodiment, the retaining ring 162 is welded to the valve opener.

As previously mentioned, the O-ring 160 is preferably in contacting relationship with the needle 130 so that it wipes the needle as it is withdrawn proximally (to the right in FIG. 11) away from the valve opener 156. The opener 156 is shown with a gap between the two legs 136 to accommodate a tip protector (not shown). The opener 156 and needle 130 are configured for use with a catheter hub in the same manner as the opener and needle shown in fig. 3.

Fig. 12 is a partial cross-sectional perspective view of yet another alternative valve opener 166 provided in accordance with aspects of the present invention. In the illustrated embodiment, an annular groove 168 is incorporated in the well 158 to accommodate an elastomeric or TPE wiper 170. The wiper 170 resembles a flat O-ring like donut, but in practice it may also be an O-ring. This configuration enables a conventional valve opener to be used with a variety of needle outer diameters and O-ring inner diameters. The wiper 170 is retained within the well 158 without a separate retaining ring (e.g., ring 162 in fig. 11). The wiper 170 may snap fit into the groove 168 during assembly.

FIG. 13 is a cross-sectional side view of yet another alternative catheter assembly provided in accordance with aspects of the present invention, which is generally designated 200. Catheter assembly 200 incorporates components similar to the assembly shown in fig. 8C and 9D, including catheter tube 12 attached to catheter hub 14, needle 16 attached to needle hub 18, hemostasis valve 46, valve opener 48 including a pair of legs 60 (only one shown) disposed in corresponding slots 28 in catheter hub 14, a wiper (not shown) attached to either of catheter hub 14 and valve opener 48, and tip protector 202 for blocking needle tip 72. However, rather than placing tip protector 202 in the gap defined by the two legs 60 in valve opener 48, a third housing 204 is incorporated to accommodate the tip protector. Additionally, a wiper (not shown) may be attached to the third housing 204 distal to the tip protector 202 to wipe the needle as it is withdrawn after insertion of the catheter.

In an exemplary embodiment, the third housing 204 incorporates a back plate or panel 206 that is attached to a closed housing portion 208 to close an opening 207 in the closed housing portion 208. An opening 207 in the closed housing portion 208 allows the tip protector 202 to be placed therein during assembly. The back plate 206 may be attached to the housing portion 208 by using an adhesive, welding, or detent. Alternatively, the closed housing portion 208 may incorporate an opening on a side orthogonal to the back plate 206.

The third housing 204 incorporates a pair of arms 210 each including a hook 212. Two hooks 212 are configured to engage two projections 36 to hold third housing 204 on catheter hub 14 in a ready-to-use position. The two arms 210 are preferably flexible to provide a clamping force against the two projections 36 that is higher than the frictional force of withdrawing the needle through the tip protector 202, hemostasis valve 46, and catheter 12. Alternatively, the two arms 210 may be biased radially outward to increase the clamping force. Additionally, the two arms may be biased axially inward against the needle to reduce the clamping force after the needle is withdrawn proximally of the arms 210.

After successful insertion of the catheter, the needle 16 is pulled back proximally away from the catheter tube 12 in the same manner as described above (i.e., to the right in fig. 13 and 14). As the needle tip 72 moves proximally toward the distal wall 214 of the tip protector 202, the tip protector 202 engages the needle 16, and further proximal movement of the needle 16 pulls the tip protector 202 over the back plate 206 of the third housing 204, which then disengages the two hooks 212 from the two projections 36. Thus, the clamping force between the two hooks 212 and the two projections 36 should be less than the clamping force between the tip protector 202 and the needle 16.

Referring now to fig. 14, the tip protector 202 includes a proximal wall 216, an arm 220, and a distal wall 214; the proximal wall 216 includes an opening 218, the arm 220 includes an opening 222 (fig. 13), and the distal wall 214 is located at a distal end of the arm 220. The proximal wall 216 and the arm 220 define an angle □ therebetween. In a ready-to-use position (not shown), end edge 224 of tip protector 202 is biased against a side of needle 16, and angle □ has a ready angle value □_{Then is turned on Thread guide}. When in the activated position (fig. 13 and 14), the angle □ increases to a protected angle value □_{To be received Protection of}Greater than the ready angle value □_{Ready for}. When this occurs, the arm is further tilted and the opening 222 in the arm grips the needle so that the needle is not engaged by the crimp.

Fig. 15 shows a longitudinal section of a further embodiment of a valve opener 193. The actuating end 194 is connected to two legs 195, one of which is shown in FIG. 15. In the channel 196 for receiving the needle, a wiper in the form of an annular lip 197 is provided, wherein this annular lip 197 tapers in the distal direction. This lip 197 may be integrated with the actuation end 194 by injection molding. It is also possible to provide an annular lip 197 made of a suitable material different from the actuation end 194, wherein the annular lip 197 can be connected to the actuation end by two-component injection molding. The channel 196 has the following on the proximal side: a portion with a larger taper of 60 deg. followed by a portion with a taper of 4 deg..

While limited catheter assembly embodiments and components thereof have been particularly described and illustrated, many modifications, combinations, and variations will be apparent to those skilled in the art. For example, the length, size, color and appearance of the needle hub and catheter hub may be modified, tip protectors other than those specifically incorporated herein may be used, and a single leg or two legs of different lengths may be used in addition to two equally long legs on the valve opener. Additionally, instead of placing the tip protector in the catheter hub to block the needle tip, a third housing may be incorporated to house the tip protector, and the third housing may be disposed between the catheter hub and the needle hub, as described in U.S. application serial No.10/109,797, entitled "SAFETY SPRINGCATHETER INTRODUCER ASSEMBLY", filed 3.29.2002, the contents of which are expressly incorporated herein by reference in a manner similar to that set forth in full. The third housing and tip protector may also be constructed as described in U.S. application Ser. No.10/468,923, entitled "NEEDLE ASSEMBLY WITHPROTECTIVE ELEMENT," and U.S. Pat. No.7,125,397, the contents of which are expressly incorporated herein by reference. Further, it is understood and contemplated that features specifically discussed for one valve embodiment, wiper, valve opener or tip protector may be employed for inclusion with another valve embodiment, so long as the functions are compatible. For example, although the overall combination is not clearly discussed, the needle and tip protector of fig. 6, the valve opener and wiper of fig. 10A, and the hemostatic valve of fig. 8C may be used with the catheter hub of fig. 2. Accordingly, it will be appreciated that catheter assemblies and components thereof constructed in accordance with the principles of the present invention may be implemented in ways other than those specifically described herein. The invention is also defined in the appended claims.

Claims (30)

1. A catheter assembly, comprising:

a first hub comprising a housing comprising an outer surface and an inner surface defining an interior cavity;

a tube attached to the first hub and extending distally of the first hub;

a second hub comprising a housing comprising an outer surface and an inner surface defining an interior cavity;

a needle having a needle tip attached to the second hub and projecting distally of the second hub and into the tube;

a valve comprising a top surface, a rim depending therefrom, and an opening in the top surface through which the needle projects;

a valve opener including an actuating end from which at least one leg extends proximally, an

A wiper including a perimeter defining an opening and with which the needle is in contact for wiping the needle as it is pulled back away from the tube.

2. The catheter assembly of claim 1, further comprising a tip protector disposed in the internal cavity of the first hub.

3. The catheter assembly of claim 1, wherein the wiper is attached to the valve opener.

4. The catheter assembly of claim 1, wherein the wiper is attached directly or indirectly to the first hub.

5. The catheter assembly of claim 1, wherein the wiper is liquid impermeable.

6. The catheter assembly of claim 1, wherein the needle includes a clip engaging portion.

7. The catheter assembly of claim 2, wherein the tip protector includes two arms that intersect.

8. The catheter assembly of claim 2, wherein the tip protector includes a first protector body surrounded by a second protector body.

9. The catheter assembly of claim 2, wherein the tip protector includes two arms extending at least partially to one side of the needle.

10. The catheter assembly of claim 1, wherein the first hub is a catheter hub and includes an internal protrusion.

11. The catheter assembly of claim 1, wherein the second hub is a needle hub.

12. The catheter assembly of claim 1, further comprising at least one groove formed on an inner surface of the first hub.

13. The catheter assembly of claim 1, wherein the at least one leg is disposed within the at least one slot.

14. The catheter assembly of claim 1, wherein the wiper is an O-ring.

15. A catheter assembly, comprising:

a) a catheter hub comprising a housing, the housing comprising an outer surface and an inner surface defining an interior cavity;

b) a catheter tube attached to the catheter hub and extending distally of the catheter hub;

c) a needle hub including a housing;

d) a needle having a needle tip, the needle attached to the needle hub and projecting distally of the needle hub and into the catheter tube;

e) a valve disposed in the interior cavity of the catheter hub for limiting backflow of blood;

f) a valve opener disposed on a proximal side of the valve for opening the valve; and

g) a tip protector disposed adjacent to the valve opener for blocking the needle tip, wherein the tip protector comprises:

(1) a tip protector housing having an inner surface;

(2) a first arm extending from a distal wall of the tip protector housing biased toward an inner surface of the catheter hub;

(3) a second arm extending from a proximal wall of the tip protector housing biased toward an inner surface of the catheter hub; and

(4) a third arm extending from a proximal wall of the tip protector housing biased against a side of the needle.

16. The catheter assembly of claim 15, further comprising a wiper for wiping the needle as the needle is pulled back away from the catheter tube.

17. The catheter assembly of claim 16, wherein the wiper is attached to the valve opener.

18. The catheter assembly of claim 16, wherein the wiper is attached to the catheter hub either directly or indirectly.

19. The catheter assembly of claim 15, further comprising a crimp on the needle.

20. The catheter assembly of claim 15, wherein the valve opener comprises an actuation end for opening the valve.

21. The catheter assembly of claim 20, wherein the valve opener comprises at least one leg extending proximally of the actuation end.

22. The catheter assembly of claim 21, wherein the catheter hub comprises at least one slot, and wherein the at least one leg is disposed within the at least one slot.

23. A catheter assembly, comprising:

a catheter hub comprising a housing defining an interior cavity and having a catheter tube extending distally thereof;

a needle hub including a housing defining an interior cavity and having a needle with a needle tip extending distally thereof; the needle projects into the catheter tube;

a hemostasis valve having an opening disposed within the interior cavity of the catheter hub;

a valve opener disposed adjacent the hemostasis valve and including an actuation end including a tapered portion and a pair of legs defining a gap extending proximally thereof;

a wiper for passing the needle therethrough for wiping the needle as it is withdrawn from the catheter tube; and

wherein a tip protector comprising an arm and a wall, the wall comprising an opening, and the tip protector is disposed in a gap defined by the two legs.

24. The catheter assembly of claim 23, wherein the wiper is attached to the valve opener.

25. The catheter assembly of claim 23, wherein the wiper is attached directly or indirectly to the catheter hub.

26. The catheter assembly of claim 23, wherein the wall is configured to be tilted from a first upward position to a tilted position so that the opening grips the needle.

27. The catheter assembly of claim 23, wherein the needle comprises a crimp.

28. The catheter assembly of claim 23, wherein the wiper is an O-ring.

29. The catheter assembly of claim 23, wherein the tip protector includes a first protector body surrounded by a second protector body.

30. The catheter assembly of claim 23, wherein the valve opener is in engaging contact with the hemostasis valve in a ready-to-use position.