HK1237685A1 - Caps for needles and catheters - Google Patents

Description

Cap for needles and catheters

Technical Field

The disclosed invention relates generally to medical devices such as introducer needles and over-the-needle catheters, and more particularly to needles and catheters having a cap cover for covering the needle prior to use, wherein the cap cover includes a stabilizing platform to secure the catheter after successful venipuncture.

Background

Catheters are often used for a variety of infusion therapies, including infusing fluid into a patient, withdrawing blood from a patient, or detecting various parameters of the patient's vascular system. The catheter is typically connected to a catheter adapter that is adapted to attach IV tubing to the catheter. Needles used with catheter tubes have a sharp tip, which is typically covered by a cap during packaging of the catheter assembly. The sharp tip of such needles poses a safety risk, which is often overcome by including a removable cap covering the needle tip and at least a portion of the assembly in a thermoplastic wrap or vacuum bag. After removal of the encapsulation material, the cap is often removed and discarded. After the catheter tube is placed into the patient's blood vessel and before or after the catheter hub is connected to the IV fluid source, the hub is secured, for example by adhering the catheter hub to the patient's skin, to protect the access site from inadvertent movement.

Disclosure of Invention

Aspects of the present disclosure relate to a needle assembly comprising: a needle having a needle shaft attached to a needle hub; and a protective cap positioned to overlie the needle shaft, the protective cap comprising a first section and a second section; the first section having a bore with a needle shaft positioned therein and the second section including a base covering at least a portion of the needle hub; and a frangible section formed between the first section and the second section; and wherein the frangible section is breakable to separate the first section from the second section.

Another aspect of the present disclosure relates to a needle assembly comprising a needle attached to a needle hub and a protective cap positioned to overlie at least a portion of the needle, and wherein the protective cap is separable along a detachment line into at least two distinct sections, a first section and a second section, and wherein one of the two sections can be reused as a fixation device.

The needle assembly may comprise a catheter hub attached to a catheter tube, and wherein the shaft of the needle protrudes through the catheter tube.

The catheter hub may comprise an opening or a protrusion and wherein the cap may comprise the other of said opening or said protrusion. The protrusion may protrude through the opening. The projection may comprise a mushroom-shaped head, arrow, barb, or rotatable lug.

A stabilizing element may be included and may be folded over the second section of the protective cap. An adhesive pad may be attached to each stabilization element. Each adhesive pad may include a release layer.

When two stabilizing elements are folded, an adhesive may be included to hold the folded ends in the folded position, or the stabilizing elements may be sufficiently soft and pliable to hold the fold without the aid of an adhesive.

A needle guard may be positioned within the catheter hub. The needle guard may include a proximal wall having an opening and two arms. The two arms may intersect and the two arms may each comprise a distal wall.

The second section of the cap may have two side walls and have a top wall with a tapered distal section. The top wall may be flat, may include texture, may include angles, may include ribs, or a combination thereof.

The first section of the protective cap may include an elongate tubular or barrel portion and an expanded or enlarged proximal body portion. The elongate tube and the enlarged proximal body portion may have a bore for receiving a needle.

The needle assembly may further include an adhesive pad formed in a U-shape, a portion of the adhesive pad being attachable to the stabilization element.

The needle assembly may include wings having adjustable portions, such as portions that may be trimmed or removed to change the shape of the wings.

The needle assembly may include means to attach the first section to the second section at a detachment line. The tool may include a perforation, a weakened portion, or one or more mechanical interengagement. The detachment line may be straight, may be curved, or may be wavy. The mechanical interengagement, which may also be referred to as a coupling means, may include a combination of protrusions and receptacles or a combination of lugs and receptacles, similar to the interlocking lugs on a puzzle. The protrusion may be a post, a rounded section, or a hemispherical section.

In some examples, the receptacle may be formed on a tab, and the tab may extend out of the proximal end of the first section or out of the distal end of the second section.

A glider may be used to help guide the lug into engagement with the receptacle. The first section may be utilized to form a sliding aid. The second section is slidable on the sliding aid when the lug and the receptacle of the attachment are engaged.

In an example, the detachment line may have a residue of a torn or broken surface when the first segment is separated from the second segment. In other examples, the tear line may have a flush edge, such as an edge formed by molding. For example, when the bonding apparatus is separated to separate the first section from the second section, the edges on the first and second sections may be clean and may be free of marks or residue of torn or broken surfaces.

The wings may be integrally formed to the base portion of the second section or formed separately and subsequently attached to the base portion, for example by welding or by gluing.

In some examples, when separating the first section from the second section, the proximal end of the first section may have a tab extending proximally of the proximal end of the first section. In other examples, the proximal end of the first section may have lugs each with at least one receptacle that extend proximally of the proximal end of the first section.

Aspects of the present disclosure also relate to a needle assembly, comprising: a catheter hub; a catheter tube extending from the distal end of the catheter hub; a needle disposed at least partially within the catheter tube; a needle hub attached to the needle; a needle cap positioned to overlie the needle and the catheter tube; the needle cap comprises a first section and a second section, the first section comprising an elongate sleeve having a bore and the second section comprising a base portion comprising an upper opening and a lower opening and covering at least a portion of a catheter hub; at least one stabilizing element extending laterally of the base portion; and wherein the engagement element on the catheter hub is sized and shaped to extend through the upper opening of the base portion after separating the first section from the second section along the detachment line.

The needle assembly may further comprise an adhesive pad attached to the at least one stabilizing element.

The needle assembly, wherein the at least one stabilizing element may be a first wing, and wherein a second wing extending from the base portion may be included.

The needle assembly may further include a tab on the proximal end of the second section sized and shaped to assist in removing the second section from the catheter hub.

The needle assembly may further include an adhesive pad formed in a U-shape, a portion of the adhesive pad being attached to each of the two wings.

The needle assembly, wherein the upper opening of the second section may be a slot.

The needle assembly, wherein the engagement element may comprise a hook.

A needle assembly, wherein the joining means can join the first section to the second section at a detachment line.

The needle assembly wherein the binding means may comprise two or more projections engaging two or more receptacles or two or more lugs engaging two or more receptacles.

The needle assembly wherein the line of detachment may be narrow or wavy.

A needle assembly wherein the binding may be guided by one or more sliding aids.

The needle assembly wherein the receptacle may be positioned on a lug extending at the proximal end of the first section.

Yet another additional feature of the present disclosure is a method of stabilizing a puncture site, the method comprising: separating the first section of the protective cap from the second section along the detachment line; the first section comprises an elongate sleeve having a bore and the second section has a base portion comprising two side walls and comprising a top wall; placing the second section over the catheter hub such that a base portion of the second section covers at least a portion of the catheter hub; and using an adhesive to secure the base portion against inadvertent removal.

The method may further include securing two wings with an adhesive, the two wings extending laterally of the base portion.

The method may further include placing a lug on the catheter hub through a slot on the base section.

The method wherein adhesive may be applied to each of the two wings.

The method wherein the line of detachment may be a frangible section positioned between the first section and the second section.

The present disclosure also relates to a method of manufacturing a needle assembly as disclosed elsewhere herein.

Still additional features of the present disclosure include a needle assembly comprising: a needle having a needle shaft attached to a needle hub, the needle shaft including a needle tip; and a protective cap positioned to overlie the needle shaft, the protective cap comprising a first section and a second section; the first section having a bore with a needle shaft positioned therein and the second section including a base covering at least a portion of the needle hub; and a detachment line formed between the first section and the second section; and wherein the detachment line is a weakened section configured to be broken to separate the first section from the second section.

Yet another aspect of the present disclosure includes a method of stabilizing a puncture site. The method may comprise: separating the protective cap into a first section and a second section along a detachment line; the first section comprises an elongate sleeve having a bore and the second section has a base portion comprising two side walls and comprising a top wall; placing the second section over the catheter hub such that a base portion of the second section covers at least a portion of the catheter hub; and using an adhesive to secure the base portion against inadvertent removal.

Drawings

These and other features and advantages of the apparatus, systems, and methods of the present invention will be appreciated, as the same becomes better understood with reference to the specification, claims, and accompanying drawings, in which:

figure 1A shows a perspective view of the device with the protective cap still attached;

FIG. 1B shows a partially exploded perspective view of the device of FIG. 1A;

FIG. 2 shows a top view of a device with a stabilization element;

FIG. 3 shows a side view of the device of FIG. 2;

FIG. 4A shows a side view of an embodiment of the device just prior to separation;

FIG. 4B shows a side view of an embodiment of the device after detachment;

FIG. 5 shows a perspective view of a second section of the device;

FIG. 6 shows a top view of the second section attached to the catheter hub; and is

FIG. 7 shows a perspective view of an embodiment of a device having a dressing;

figure 8 shows the securing means being part of the cap after removal of the first section of the protective cap;

9A-9D illustrate alternative protective caps at different viewing angles and in different cross-sections;

fig. 10A-10D show alternative protective caps at different viewing angles and in different cross-sections.

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 the needle assembly provided in accordance with aspects of the devices, systems, and methods of the present invention, and is not intended to represent the only forms in which the devices, systems, and methods of the present invention may be constructed or utilized, the needle assembly having a cap with stabilizing features. The description sets forth the features and the steps for constructing and using embodiments of the apparatus, system, and method of the present invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the disclosure. As noted elsewhere herein, the same reference numerals are intended to indicate the same or similar elements or features.

Fig. 1A shows a perspective view of a needle assembly 500, the needle assembly 500 comprising a catheter over-needle assembly 120 and a cover or cap 5, the cover or cap 5 being typically frictionally and/or positively engaged (posively engaged) to and removable from the catheter assembly. The cover or cap 5 may be used to cover the needle 15 with a sharp or distal tip 37 and act as a protective cap to cover the needle 15 until use. In an example, the cover 5 may comprise two or more sections 10, 20, the two or more sections 10, 20 being joined together, e.g. integrally formed with each other or mechanically fixed to each other. The first segment 10 generally covers the needle 15 and catheter tube 76 of the catheter assembly 120 when placed over the catheter assembly 120 prior to use (e.g., when the assembly is enclosed in a plastic wrap or vacuum bag). The needle 15 has a needle shaft 23, a tip 37, and optionally a change in profile for interacting with the needle guard, such as a crimp or bump near the needle tip 37.

The second section 20 of the cap 5 is attached to the first section 10 and covers the catheter hub 75 or at least a portion of the catheter hub, and may engage or frictionally grip (grip) the catheter hub 75 to secure the cap 5 to the catheter assembly 120. In some examples, the second section 20 may catch a flange or lug on the needle hub 35. As discussed further below, the second segment 20 may be referred to as an anchoring or fixation device, and the first segment 10 may be referred to as a protective sleeve. After the cap 5 is removed from the catheter assembly 120, the two sections 10, 20 may be separated or detached from each other at a detachment line 30, which is positioned between the distal and proximal ends of the cap 5. The tear line 30 may be a frangible or weakened section and may be configured to tear or separate easily under relatively low forces. The tear line 30 may be a perforation, a thinner section that is more weakened than the rest of the cover, a groove or any other structural design that inherently weakens the structural integrity of the cap and results in splitting into at least two separate sections 10, 20 when a sufficient level of force is applied. The severance lines 30 may be linear or straight, curved, zig-zag, or a combination thereof. Alternatively, as discussed further below, the at least two separate sections 10, 20 may be removably connected using a snap-fit arrangement, an engagement arrangement, a detent arrangement, or a combination thereof, and the detachment line 30 between the two sections 10, 20 may be separated by: disengaging the snap fit, disengaging the engagement arrangement, or disengaging the pawl.

In some examples, when the needle 15 is withdrawn from the catheter hub and catheter tube 76, such as after a successful venipuncture, a needle guard may be positioned within the catheter hub 75 so as to cover the needle tip 37. An exemplary needle guard may include a proximal wall having a perimeter defining an opening, two arms extending distally of the proximal wall, and a distal wall positioned on each arm to block a needle tip. When viewed from the side, the two arms may intersect each other in two positions: ready for use on a patient and in a protective position where the needle guard covers the needle tip to prevent inadvertent needle sticks. The needle guard may interact with a contour-changing portion on the needle shaft. For example, when the needle is withdrawn from the catheter hub after a successful venipuncture, the change in profile can engage a boundary on the proximal wall to withdraw the needle guard away from the catheter hub. In some examples, the cap 5 is used with a needle device without a catheter tube, such as a hypodermic needle or an epidural needle. Exemplary needle guards that can be used with needle assembly 500 of the present disclosure include the needle guard disclosed in U.S. patent No.8,647,313, the contents of U.S. patent No.8,647,313 being expressly incorporated herein by reference as if fully set forth herein.

The first section 10 of the cap 5 is generally elongate and has apertures for receiving and covering the needle 15 and the catheter tube 76 to prevent accidental needle sticks by the user prior to use and/or to protect the plastic wrap when the needle device 500 is positioned within the package. As shown, the first section 10 is generally cylindrical in cross-section, but may also embody other shapes, such as conical, oval, compound, irregular, polygonal, and the like. The distal tip 12 of the first section 10 is shown, the distal tip 12 sometimes also referred to as a tip, the distal tip 12 being configured to cover the tip of the needle, the distal tip 12 having a flat wall surface with one or more optional openings for venting air. The main body portion 14 of the first section 10 is sized and shaped to cover the length of the needle 15 and catheter tube 76. The length of the first section 10 may be longer than the length of the needle 15 protruding out of the catheter hub 75 to ensure sufficient clearance, space or clearance with the needle tip 37. When the first section 10 takes a relatively long length, it will allow the cap 5 to be used on different assemblies having different needle lengths. In some examples, the cap 5 is configured to cover or house a needle without a catheter tube, such as an injection needle or an epidural needle. The exact portion of the length of the needle and catheter tube that is covered by the body portion 14 can vary and can depend on various design factors. In one embodiment, the diameter of the body portion 14 is substantially constant along its longitudinal axis. In other embodiments, the diameter may taper away from or toward the distal tip 12. The body portion 14 of the cap 5 has a proximal body portion 16, the proximal body portion 16 transitioning the body portion 14 from a smaller diameter cross-section at a distal end 18 (fig. 2) to an enlarged cross-sectional area at a proximal end 19, the proximal end 19 being attached to a second section 20 of the cap 5, as discussed further below. Thus, as shown, the first section 10 of the cap 5 has an elongated body portion or elongated sleeve 17 and a proximal body portion 16, the proximal body portion 16 having a distal end 18 and a proximal end 19.

In some examples, the proximal body portion 16 includes a shoulder 33 (fig. 2) at the distal end 18 of the proximal body portion. Shoulder 33 rises to a larger cross-sectional dimension and the dimension of this larger portion remains constant for the proximal end, varying dimensions are also contemplated. In embodiments having a tapered proximal body portion 16, the taper begins at the distal end 18 of the proximal portion. From this point, the inner and outer dimensions of the taper increase along the longitudinal axis of the proximal body portion 16 until they match the inner and outer dimensions of the base portion 40 of the second section 20 (fig. 2) discussed below, the base portion 40 sometimes being referred to simply as the "base". The tapered proximal body portion 16 has two side walls 22, 24, the two side walls 22, 24 transitioning from vertical to horizontal at a top 122 to meet at a seam 124, the tapered proximal body portion 16 having an opening 26 located opposite the top 122 (fig. 1A). In some examples, seam 124 is simply a raised section or crest line at top 122. In other examples, the seam is omitted or not readily perceptible. This configuration of the side walls 22, 24 with the lower side opening 26 is configured to accommodate attachment of the cap 5 to the rest of the catheter assembly and removal of the cap 5 from the rest of the catheter assembly for disengagement from engagement with the catheter hub 75, the needle hub 35, or both.

The second section 20, when positioned to overlie the catheter assembly 120, substantially covers the catheter hub 75 and optionally a portion of the needle hub 35. In addition to covering the catheter hub 75, the second section 20 has additional functions not appreciated, or disclosed by any known prior art. In the present disclosure, the second section 20 doubles as a stabilization platform in addition to serving as a cover for the catheter hub and/or the needle hub. The second section 20 has a base portion 40, a top surface section or upper panel 56, and an opening 105 (fig. 5) opposite the top surface section 56, the base portion 40 being sized and shaped to cover the catheter hub 75. In other embodiments, the base portion 40 is of sufficient size to cover all or part of the needle hub 35, the catheter hub 75, or both. After venipuncture is successful and the catheter hub 76 is placed within the blood vessel, the second section 20 can be separated from the first section 10 and can be placed over the catheter hub 75 again without the first section 10 to stabilize the puncture site. The second section 20 may be provided with adhesive, applied with adhesive, or both, in order to anchor the hub, such as a needle hub or a catheter hub, within the second section 20 and against or to the patient. When used with a needle without a catheter hub, such as a Seldinger needle, the second section 20 can be placed over the needle hub to stabilize the needle hub.

Fig. 1B shows the cap 5 separated from the catheter assembly 120 of fig. 1A, for example, before use of the catheter assembly. Needle 15, needle hub 35, catheter tube 76, and catheter hub 75 remain connected for venipuncture. The cap 5 of fig. 1A and 1B may include wings or stabilizing elements 42, 44, the wings or stabilizing elements 42, 44 extending laterally of the second section 20, as discussed further below.

Fig. 2 shows a top view of the cover 5 of fig. 1A and 1B with wings 42, 44. The tear line 30 is visible at the intersection between the proximal body portion 16 of the first section 10 and the base portion 40 of the second section 20. In the illustrated embodiment, the detachment line 30 is a perforation formed during injection molding to form the cover, which may be made of many known thermoplastics and is generally made using a translucent finished product with a transparent cover (or an opaque cover is also contemplated). Alternatively, the perforation lines may be formed in a post-molding process, such as using laser techniques to weaken sections of the protective cover to facilitate separation. In some examples, the line of detachment 30 includes a weakened section (e.g., a thin section) that is easily torn to separate the first section 10 from the second section 20. In still other examples, the first and second sections 10, 20 may be disassembled along a disassembly line by removing or disengaging mechanical interengagement, as discussed further below. The inclusion of the tear line 30 allows a user to easily separate the first section 10 from the second section 20 by physical means, such as by shearing, tearing, deforming, cutting, untwisting, removing, or twisting. The disassembly process will be discussed in more detail below.

Extending laterally from both sides 130, 132 of the base portion 40 are stabilizing elements 42, 44, which stabilizing elements 42, 44 may also be referred to as wings. In an example, the stabilizing elements 42, 44 are flat and pliable such that they can be folded around the base section 40 when enclosed in a sock, and unfolded to form an anchor point for attaching the second section 20 overlying the catheter hub to a patient using one or more pieces of medical tape, as further discussed with reference to fig. 8. The stabilizing elements 42, 44 may be embodied as wings having any number of features formed thereon, including openings or holes, bumps or protrusions for gripping, and/or design features for aesthetics. Instead of, or in addition to, using external or separate medical tape, each stabilizing element 42, 44 may include an adhesive layer 26 (fig. 3) with a peelable release layer on a bottom surface 48 (fig. 3) of each element 42, 44 or without any adhesive layer. The pliability of the stabilizing elements 42, 44 allows them to be folded over the base portion 40 so as to fold about the longitudinal axis of the cap and wrap over the top surface of the second section 20 during packaging and storage of the catheter assembly, as will be discussed further below. In other embodiments, the stabilizing elements 42, 44 are relatively stronger, stiffer, or rigid so that they do not fold over the second section 20 during packaging and storage. Alternatively, the sock can be sized and shaped to receive an assembly having the wings in an extended state, as shown. In still other embodiments, the stabilizing elements are omitted and the medical tape is applied directly on the base portion 40 of the second section 20 without any stabilizing elements. In another embodiment, the stabilizing elements or wings 42, 44 are made of a soft material without any tacky material. In yet another embodiment, the fixation device 20 and wings 42, 44 are made of a single soft material, such as a soft plastic, that is molded together as a single piece. The fixation device 20 and wings 42, 44 being formed as a single piece from a soft material allows the fixation device 20 and wings 42, 44 to bend, flex, or otherwise be flexible to fit to a medical device or against a patient. In another embodiment, the fixation device and wings are made of a single hard material (e.g., a hard plastic) that is molded together as one piece. Each wing 42, 44 may be formed as a single piece structure that is formed to the base portion 40, or each wing 42, 44 may be formed from two or more components that are bonded together using an adhesive, welding, or other bonding technique.

The wings 42, 44 may be formed to have any size and shape that will allow a user to attach the wings 42, 44 to the patient 110 or otherwise secure the wings to the patient 110 (fig. 7). In the illustrated embodiment, the wings 42, 44 may optionally include frangible or adjustable portions 52, 54 along or near the outer edges 62, 64 of each stabilization element 42, 44. The wing frangible or adjustable portions 52, 54 allow the wings 42, 44 to be resized (e.g., reduced in area) to match the size of the area on the patient or the size of the patient where the catheter is placed. In still other examples, wings 42, 44 may include rows of frangible lines or adjustable lines to allow for various choices of resizing depending on which frangible line is chosen for separation. For embodiments without any wings, the tape may be applied directly to the base portion 40 of the second section 20. A slot or opening 55 (fig. 2) is provided in a top surface portion or upper panel 56 of the base portion 40 near a proximal end 58 of the base portion 40. The slot or opening 55 is configured for mechanical engagement between the second section 20 and the catheter hub 75, as will be discussed in more detail below.

Fig. 3 shows a side view of the cover 5 of fig. 2. Shown in this view of the cover 5 is the first side wall 22 of the proximal body portion 16 of the first section 10, the first side wall 22 having a wall surface that tapers outwardly from the longitudinal axis and from the maximum outside dimension of the tube portion 60. The tapered proximal body portion 16 includes a corresponding second sidewall 24 on the opposite side (fig. 1A). The first sidewall 22 of the tapered proximal portion 16 transitions to the top surface 122 of fig. 3, the top surface 122 connecting to the second sidewall 24. At the top surface 122, a ridge 62 is provided, the ridge 62 defining a centerline of the top surface that runs along the longitudinal axis. An upper panel 56, which may be flat or have a curved portion, is positioned at the proximal end of the second section 20, which forms the top of the base portion 40. Lugs 64 are formed on the flat panel 56 at the proximal end 58, the lugs 64 being embodied in one example as vertical walls, with tapered walls also being contemplated. The tab 64 provides a means of assistance (riverage) for the user to grasp when the cover 5 is removed from the catheter assembly or needle device prior to use. The tab 64 also provides the user with some additional aid to separate, advance, disengage and/or rotate the proximal body portion 16 of the first section 10 to disengage the catheter assembly to remove the cap therefrom. Additionally, the tabs 64 may provide stability to the stabilization elements 42, 44 when the stabilization elements 42, 44 are folded over the top panel 56 of the base portion 40 of the second segment 20 during packaging and storage. In other embodiments, the lugs 64 may be omitted, may be made taller, shorter, wider, or may have other shapes or curvatures. The adhesive pad 46 shown with the stabilizing element 42 has a removable liner (e.g., a release layer) to protect the adhesive as is widely known in the art. In other embodiments, the adhesive pad 46 may be omitted and medical tape may instead be used to adhere the stabilization elements 42, 44 (fig. 2) to the patient. In still other embodiments, a dressing may be used in place of or in combination with medical tape. The dressing is discussed in more detail below.

Fig. 4A shows the cap 5 after removal from the needle and needle hub, and fig. 4B shows the first section 10 of the cap 5 separated from the second section 20 at a detachment point or line 30. After successful venipuncture using the catheter assembly 120 of fig. 1A and 1B and removal of the needle and needle hub from the catheter tube and catheter hub, the cap 5 may be used to stabilize the catheter hub 75 on the patient to stabilize and/or secure the catheter hub and puncture site. As shown in fig. 4B, the cap 5 is separated into two sections 10, 20 along a tear-off line 30. The tear line 30 is frangible and is configured to be easily torn or separated. The detachment line 30 may be a perforation, a thinner section that is more weakened than the rest of the cover, a groove, or any other structural design that would cause inherent weakening and cause splitting or breaking into at least two separate sections 10, 20 at the detachment line when a sufficient level of force is applied. Alternatively, the first and second sections 10, 20 may be mechanically secured to one another at the detachment line 30 and both may be separable from one another by undoing, releasing, unbuckling, or otherwise separating the mechanical connection at the detachment line 30. Preferably, the detachment line 30 is configured such that the level of force that occurs by chance will not be sufficient to cause the cap to split or separate into the two sections 10, 20. However, without departing from the scope of the present disclosure, the level of force required to separate the caps at the detachment line 30 may be adjusted, for example, by increasing the gap or length between perforations or increasing or decreasing the material thickness of the weakened section. To cause separation of the two sections 10, 20, the user applies a force to increase the tension along the underside 140 of the cap 5. Once the material of the cap 5 begins to tear along the tear line 30, the user continues to apply force until the tear progresses to the top of the cap 5. At that point, the user applies a force to tear the material across the top of the cap 5 along the tear line 30. Of course, other ways of disconnecting the first section from the second section may be used, such as using scissors.

After separation, the first section 10 may be discarded or recycled. With the first section 10 detached from the second section 20, the second section 20 can be reused as a fixture. In an example, the second section 20 includes a base portion 40, a sidewall 130, and an opening 105 on a side opposite the top surface 56, the second section 20 being sized and shaped to couple with the catheter hub 75 (fig. 1) to secure the catheter hub after venipuncture. By securing the catheter hub 75, undesired movement of the puncture site caused by movement of the catheter hub may be prevented. Thus, aspects of the present disclosure include a portion of the cap 5 used to cover the needle during packaging that is retained for subsequent use after removal of the cap from the needle. For example, the second section 20 may be detached from the first portion 10 and retained for reuse, for example by placing the second section 20 over a catheter hub to stabilize the catheter hub. If stabilizing elements 42, 44 are included and stabilizing elements 42, 44 are folded, they are moved from the folded position to a second, standby or extended position, as shown in fig. 4B of fig. 5. In this embodiment, after removal of the removable liner 78 from each adhesive pad 46, the soft adhesive pad 46 with the two wings disposed together may be used to secure the wings or stabilization elements 42, 44 to the patient. In other embodiments, external medical tape is used to secure the stabilization members 42, 44 to the patient. In still other examples, both adhesive pads 46 on both wings 42, 44 and external medical tape are used to secure the second section 20 to the patient. The second section 20 may also be secured to the patient using a mechanical engagement or connection between the catheter hub 75 and the base portion 40. For example, lugs or threads on the catheter hub may protrude through slots 55 (fig. 2 and 5) on the second section 20 to mechanically engage the catheter hub and the second section 20, which may be referred to as anchors or fixation devices.

Fig. 5 shows the second section, anchor or fixation device 20 after separation from the first section 10, and the second section, anchor or fixation device 20 is oriented such that the stabilization elements 42, 44 extend away from the base portion 40 and the opening 105 on the underside of the base portion 40 faces toward the bottom of fig. 5, which generally corresponds to its normal use position when positioned overlying the catheter hub 75. Fig. 6 shows the second section 20 placed overlying the catheter hub 75, for example, after venipuncture is successful and the catheter tube 76 is placed into the patient's blood vessel. To ensure that base portion 40 of anchor portion 20 is aligned with catheter hub 75 and that the two engage to provide sufficient stability to the catheter hub, a slot or opening 55 on top surface section 56 of base portion 50 just distal of lug 64 may be placed around engagement element 82, which engagement element 82 may be a protrusion, lug, rib, or threaded portion formed on catheter hub 75. In some embodiments, the positions of the slots/openings 55 and projections 82 may be reversed, i.e., the catheter hub includes a recess and the base portion 40 includes a projection for projecting into the recess on the catheter hub. The height of the two side walls 130, 132 can be selected such that at least a portion of the inner wall of the top surface section 56 pushes against the catheter hub 75 to securely fix the catheter hub within the interior chamber or space 144 of the anchor portion 20. In other examples, the two sidewalls 130, 132 are selected such that the inner wall of the top surface section 56 does not push against the catheter hub. By placing the second section 20 overlying the catheter hub 75, the catheter hub is protected or secured against undesired movement or at least prevented from excessive movement. In some embodiments, the engagement elements 82 may comprise simple vertical lugs or ribs. In another example, the engagement element 82 may include a shaped lug that includes two structural members 90, 92. The first member 90 may include a vertical section or base and the second member 92 may include a radially extending section, which may be an angled section like a rib, barb, or hook. This allows the engagement member or element 82 to form a more secure mechanical engagement with the slot 55 when the hook 92 is placed through the slot 55. In this way, the catheter hub 75 is mechanically joined to the base portion 40 and the fixation is not solely based on adhesive or tape.

In other embodiments, the engaging element 82 may comprise a single "T" shaped element, wherein the cross-bar of the "T" shaped element compresses as it enters the slot 55 and then expands once it exits the slot 55. Other alternative engagement elements 82 may include a stem extending from the catheter hub 75 having a hemispherical structure as a top, similar to a mushroom head. The hemispherical structure will compress radially as it enters slot 44 (which may be circular) and then expand back as it exits the slot. A slit or slot may be provided on the hemispherical structure to facilitate buckling. In yet another embodiment, a rotatable latch may be used to secure catheter hub 75 to anchor 20. In yet another example, the engagement element 82 is sized such that it frictionally engages the slot 55 or an interference fit within the slot 55.

Fig. 7 illustrates an alternative embodiment in which adhesive pads are used to secure the stabilization elements 42, 44 of the anchor 20 to the patient, which may be the same or substantially the same as the anchors discussed elsewhere herein. In this embodiment, an "U" -shaped adhesive pad or dressing 146 may be used to attach the stabilization elements 42, 44 extending from the base portion 40 to the patient 110. The adhesive pad or dressing 146 is "U" shaped with a base 180 that is placed distal to where the catheter hub 76 enters the patient 110. The two sides 182, 184 of the "U" shape extend proximally from the base 180 and extend across the stabilizing elements or wings 42, 44. In some embodiments, the sides 182, 184 of the "U" shaped pad may be narrower than the width of the stabilization element, may have the same width as the stabilization element, or may be wider than the width of the stabilization element. The two sides 182, 184 should extend proximally sufficiently beyond the ends of the two wings so that they can contact the patient's skin to more securely hold the wings 42, 44 to the patient. In some embodiments, the dressing 146 is sized and shaped such that it covers all of the stabilizing elements 42, 44. In other embodiments, the dressing may leave some of one or both stabilizing elements 42, 44 exposed and uncovered. In still other embodiments, the dressing 146 may be positioned short of the side or proximal edge of the stabilization elements 42, 44. Other embodiments may use other shaped dressings, including "V" shaped dressings, "D" shaped dressings, or dressings extending from each stabilizing element 42 in a wide variety of shapes, including square, rectangular, triangular, and semi-circular.

In some embodiments, the dressing 146 is made integral with the base portion 40 of the second section or anchor 20, and the stabilizing element 42 (e.g., wings) may be omitted. For example, the sides 182, 184 of the "U" shaped pad may be pre-attached to the sides of the base portion 40 of the second segment anchor 20. In use, after insertion of a catheter, the user separates the two sections 10, 20 of the protective cap 5 and then places the base portion 40 of the second section 20 onto the catheter hub 75 and detaches the release liner 78 from the dressing 146 and attaches the dressing to the skin of the patient. The dressing may be made of a soft material to provide additional stabilization by firmly adhering to the patient's skin with a greater contact surface area with the catheter. In one example, the sides 182, 184 of the dressing 146 are unrolled from the sides of the base portion 40, the release liner is removed from each side, and then firmly applied to the patient's skin.

Fig. 8 shows an exemplary embodiment of the second segment, fixation device or anchor 20 detached from the first segment 10, and wherein the stabilizing elements 42, 44 (e.g., wings) are folded over the base portion 40 of the second segment 20. Stabilizing elements 42, 44 may be folded as shown to help encapsulate cap 5 mounted over a needle device or catheter assembly with anchor 20 of fig. 8. The folded configuration of the wings provides a relatively smaller width profile and, therefore, a relatively smaller packaging of the needle device. The stabilization elements 42, 44 are each shown with an adhesive pad 46 and a release liner 78. The stabilization elements 42, 44 may be flexible and maintained in the folded configuration as shown without any restraint or retention measures. In other examples, repositionable adhesive or other removable adhesive may be used to hold the distal end of each wing in a folded state.

Fig. 9A shows a protective cap 5 having a first section 10 and a second section 20, similar to other protective caps discussed elsewhere herein. In this embodiment, the first and second sections 10, 20 may be mechanically secured to each other along the detachment line 30 or near the detachment line 30 using a bonding device. The joining means for joining the first section 10 to the second section 20 may be included inside the cap 5, so that a smooth profile is provided outside for aesthetic purposes. In an example, the bonding means is sized and shaped to provide a smooth outer transition at the two outer bonding surfaces 220a, 220b at or near the detachment line 30. Markings or markings 232 may be provided on the exterior of the base section 40 to aid in aligning the components of the bonding apparatus, as discussed further below.

Fig. 9B shows a sectional side view of the cap 5 taken in the longitudinal direction of the cap shown in fig. 9A. In an example, two coupling means 222 (only one shown) may be provided inside the cap 5. For example, one coupling means 222 may be provided on each longitudinal half of the cap, for example along a section of one of the inner side wall 224 of the base portion 40 and the inner side wall 226 of the proximal body portion 16 of the first section 10. The coupling devices 222 may each include one or more protrusions 228 to engage corresponding receptacles 230, similar to a hole and pin or snap-fit configuration. In the illustrated embodiment, for each coupling device 222, two projections 228 are provided with the base portion 40 so as to project into two receptacles 230 provided with the proximal body portion 16. However, the position of the protrusion and receptacle may be reversed, i.e., the protrusion is with the proximal body portion 16. The engagement between each pair of projections 228 and receptacles 230 may be a tight fit, a friction fit, or an interference fit. In an example, two tabs 228 may be formed directly with the inner sidewall 224 of the second section 20, and the receptacle 230 may be provided on a lug or extension 234 extending from the end of the first section 10.

To separate the first section 10 from the second section 20, the user simply splays the two side walls 130, 132 away from each other or presses the two side walls 130, 132 together, depending on whether the protrusion 228 is with the base portion 40 or the proximal body portion 16. This will separate the protrusion 228 from the receptacle 230 to allow the first and second sections 10, 20 to be separated from each other at the detachment line 30. Once separated, the second portion 20 may be used to secure a catheter hub, as discussed elsewhere herein.

Fig. 9C shows the first section 10 of the cap 5 shown in fig. 9A separated from the second section 20.

Fig. 9D shows the second section 20 of the cap 5 of fig. 9A separated from the first section 10. In an example, the projections 228 are embodied as short pegs or posts. In other examples, the protrusion 228 is embodied as a dome-shaped section or a partial spherical surface, as shown in fig. 9D.

Fig. 10A shows a protective cap 5 having a first section 10 and a second section 20, similar to other protective caps discussed elsewhere herein. In this embodiment, the first and second sections 10, 20 may be mechanically secured to each other along the detachment line 30 or near the detachment line 30 using the coupling device 222. As shown, the unraveling line of the present embodiment may not be straight, for example, curved or wavy. The joining means 222 for joining the first section 10 to the second section 20 may be included in the wall surface of the cap 5 and engaged such that a smooth profile is provided on the outside for aesthetic purposes.

In an example, the coupling device 222 may include a plurality of interlocking lugs 240, the plurality of interlocking lugs 240 engaging a plurality of corresponding receptacles 246, similar to the interlocking lugs on a puzzle. In the example shown, there are four lugs 240 to engage four corresponding receptacles 246. In other examples, there may be fewer than four lugs 40, such as three or two lugs, or there may be more than four lugs, such as five or six or more lugs, to engage the same number of receptacles 246. In an example, one tab may be included along each side of the cap and two tabs may be included on the upper section 56 of the cap 5.

Fig. 10B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction shown in fig. 10A. In an example, a coupling device 222 including a plurality of interlocking lugs and receptacles may be formed (e.g., molded) directly at the proximal end of the proximal body portion 16 and at the distal end of the base member 40. The tab and receptacle may be snapped together to mate as shown in fig. 10A and 10B.

To facilitate guiding the lug 240 to the receptacle 246 or guiding the receptacle 246 to the lug 240 to assemble the first and second sections 10, 20 together, one or more sliding aids 250 (only one shown) may optionally be provided inside the cap 5. As shown, a sliding aid 250 is shown that may be embodied as a ramp or lug, the sliding aid 250 having surface features to guide the lug and receptacle. The sliding aid 250 may extend from the first section 10 and provide a surface against which the base member 40 slides when the lug and receptacle are engaged together to join the first and second sections together. When included, the presence of the sliding aid 250 also helps prevent the first and second sections 10, 20 from moving laterally relative to each other to dislodge or separate the lug from the receptacle.

To separate the first section 10 from the second section 20, the user simply splays the two side walls 130, 132 of the base member 40 away from each other and raises the base member 40 relative to the first section 10 or lowers the first section 10 relative to the second section to separate the first and second sections 10, 20 along the separation line 30. This will disengage the lug 240 from the receptacle 240 to allow the first and second sections 10, 20 to be separated from each other at the detachment line 30. Once separated, the second portion 20 may be used to secure a catheter hub, as discussed elsewhere herein. In other examples, the first and second sections 10, 20 may simply be pulled in opposite directions to separate the first and second sections 10, 20 along the tear line.

Fig. 10C shows the first section 10 of the cap 5 shown in fig. 10A separated from the second section 20.

Fig. 10D shows the second section 20 of the cap 5 of fig. 10A separated from the first section 10.

Methods of making and using the needle devices and caps and their components disclosed elsewhere herein are within the scope of the present disclosure.

Although limited embodiments of the protective cap and catheter assembly and their components have been specifically described and illustrated herein, many modifications and changes will be apparent to those skilled in the art. Also, while the cap is described in connection with a catheter assembly, the same cap may be used on other needle devices, such as hypodermic needles, seldinger needles, and epidural needles, to name a few. Thus, it is to be understood that the protective caps and catheter assemblies and their components constructed in accordance with the principles of the disclosed devices, systems and methods may be embodied differently than as specifically described herein. The disclosure is also defined in the appended claims.

Claims (22)

1. A needle assembly (500) comprising:

a needle (15), the needle (15) having a needle shaft (23) attached to a needle hub (35), the needle shaft (23) including a needle tip (37); and

a protective cap (5), said protective cap (5) being positioned overlying said needle shaft (23), said protective cap (5) comprising a first section (10) and a second section (20); the first section (10) having a bore within which the needle shaft (23) is positioned, and the second section (20) comprising a base (40), the base (40) covering at least a portion of the needle hub (35); and

a tear-off line (30), the tear-off line (30) being positioned between the first section (10) and the second section (20); and is

Wherein the tear line (30) is a weakened section or seam held together by a joining means (222), and the tear line (30) is configured to be separable to separate the first section (10) from the second section (20).

2. The needle assembly (500) of claim 1, further comprising a catheter hub (75), the catheter hub (75) being attached to a catheter tube (76), and wherein the needle shaft (23) protrudes through the catheter tube (76).

3. The needle assembly (500) of claim 2, wherein the catheter hub (75) comprises an opening (55) or a protrusion (82), and wherein the cap (5) comprises the other of the opening (55) or the protrusion (82).

4. The needle assembly (500) of claim 3, wherein the projection (82) projects through the opening (55).

5. The needle assembly (500) according to any one of the preceding claims, wherein a stabilizing element (42, 44) extends from the second section (20).

6. The needle assembly (500) of claim 5, further comprising an adhesive pad (46), the adhesive pad (46) being attached to each stabilization element (42, 44).

7. The needle assembly (500) of any of claims 2-6, further comprising a needle guard positioned within the catheter hub (75).

8. The needle assembly (500) according to any one of the preceding claims, wherein the second section (20) comprises two side walls (130, 132) and comprises a top wall (56), the top wall (56) having a tapered distal section.

9. The needle assembly (500) of any of the preceding claims, further comprising an adhesive pad (146) formed in a U-shape, a portion of the adhesive pad being attached to the stabilizing element (42, 44).

10. The needle assembly (500) of any of the preceding claims, wherein the bonding means (222) comprises two or more protrusions (228) engaging two or more receptacles (230) or two or more tabs (240) engaging two or more receptacles (246).

11. A needle assembly (500) comprising:

a catheter hub (75);

a catheter tube (76), the catheter tube (76) extending from a distal end of the catheter hub (75);

a needle (15), the needle (15) being at least partially disposed in the catheter tube (76);

a needle hub (35), the needle hub (35) being attached to the needle (15);

a needle cap (5), the needle cap (5) being placed over the needle (15) and the catheter tube (76); the needle cap (5) comprises a first section (10) and a second section (20), the first section (10) comprising an elongated sleeve (17), the elongated sleeve (17) having a bore, and the second section (20) comprising a base portion (40), the base portion (40) comprising an upper opening (55) and a lower opening (105) and covering at least a portion of the catheter hub (75);

at least one stabilizing element (42 or 44), the at least one stabilizing element (42 or 44) extending laterally of the base portion (40); and is

Wherein the engagement element (82) on the catheter hub (75) is sized and shaped to extend through the upper opening (55) of the base portion (40) after the first section (10) is separated from the second section (20) along a detachment line (30).

12. The needle assembly (500) of claim 11, further comprising an adhesive pad (46), the adhesive pad (46) being attached to at least one stabilization element (42 or 44).

13. The needle assembly (500) of claim 11 or 12, wherein the at least one stabilizing element (42 or 44) is a first wing (42) and further comprises a second wing (44), and wherein the first wing (42) and the second wing (44) extend from the base portion (40).

14. The needle assembly (500) of any of claims 11-13, further comprising a tab (64) on a proximal end of the second section (20), the tab (64) sized and shaped to aid in removal of the second section (20) from the catheter hub (75).

15. The needle assembly (500) of claim 13 or 14, further comprising an adhesive pad (146) formed in a U-shape, a portion of the adhesive pad (146) being attached to each of the two wings (42, 44).

16. The needle assembly (500) according to any one of claims 11 to 15, wherein the upper opening (55) of the second section (20) is a slot.

17. The needle assembly (500) according to any one of claims 11-16, wherein the engagement element (82) comprises a hook.

18. A method of stabilizing a puncture site comprising:

separating the protective cap (5) along a detachment line (30) into a first section (10) and a second section (20); the first section (10) comprises an elongated sleeve (17), the elongated sleeve (17) having a bore, and the second section (20) has a base portion (40), the base portion (40) comprising two side walls (130, 132) and comprising a top wall (56);

placing the second section (20) over a catheter hub (75) such that a base portion (40) of the second section (20) covers at least a portion of the catheter hub (75); and

the base portion (20) is secured against inadvertent removal using an adhesive.

19. The method of claim 18, further comprising securing two wings (42, 44) with an adhesive, the two wings (42, 44) extending laterally of the base portion (40).

20. The method of claim 18 or 19, further comprising placing a lug (82) on the catheter hub (75) through a slot (55) on the base section (40).

21. The method of claim 19 or 20, wherein the adhesive is applied to each of the two wings (42, 44).

22. The method according to any one of claims 19-21, wherein the tear line (30) is a frangible section positioned between the first section (10) and the second section (20).