HK1237685B - Caps for needles and catheters - Google Patents

Abstract

Needle assemblies 500 are disclosed having a multi-purpose protective cap 5. The needle assemblies can embody a catheter assembly having a catheter hub 76 and a catheter tube 75 or a hypodermic needle 15 mounted on a needle hub. The multi-purpose cap includes a first section 10 covering the needle and a second section 20 having a base portion 40 for covering a hub, such as a needle hub or a catheter hub. The first section and the second section are separable from one another along a detachment line 30 and the second section 20 is re-useable as a securement device.

Description

Caps for needles and catheters

Technical Field

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

Background Art

Catheters are often used for various infusion therapies, including infusing fluids into a patient, withdrawing blood from a patient, or measuring various parameters of a patient's vascular system. The catheter is typically connected to a catheter connector that is suitable for attaching IV tubing to the catheter. The needle used with the catheter tubing has a sharp tip that is typically covered by a cap during packaging of the catheter assembly. The sharp tip of such a needle poses a safety risk that is often overcome by including a removable cap covering the needle tip and at least a portion of the assembly in a thermoplastic sheath or vacuum bag. After removing the packaging material, the cap is often removed and discarded. After the catheter tubing is placed in the patient's blood vessel and before or after the catheter hub is connected to the IV fluid source, the hub is secured to protect the entry site from inadvertent movement, for example by affixing the catheter hub to the patient's skin.

Summary of the 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 cover the needle shaft, the protective cap comprising a first section and a second section; the first section having a hole for positioning the needle shaft therein, and the second section comprising 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 capable of breaking 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, wherein the protective cap can be separated along a tear line into at least two distinct segments, namely a first segment and a second segment, and wherein one of the two segments can be reused as a securing device.

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

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

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

When the 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 remain folded without the aid of an adhesive.

The 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 cross and each arm may include a distal wall.

The second section of the cap may have two side walls and 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 elongated tubular body or cylindrical portion and an expanded or enlarged proximal body portion. The elongated tubular body and the enlarged proximal body portion may have a hole for accommodating a needle.

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

The needle assembly may include a wing having an adjustable portion, such as a portion that can be trimmed or removed to change the shape of the wing.

The needle assembly may include means for attaching the first segment to the second segment at the line of detachment. The means may include a perforation, a weakened portion, or one or more mechanical interengagements. The line of detachment may be straight, curved, or wavy. The mechanical interengagements, which may also be referred to as coupling means, may include a protrusion and receptacle combination or a lug and receptacle combination, similar to the interlocking lugs on a jigsaw puzzle. The protrusions may be posts, rounded segments, or hemispherical segments.

In some examples, the receptacle can be formed on a tab, and the tab can extend beyond the proximal end of the first segment or can extend beyond the distal end of the second segment.

A glider may be used to help guide the lug into engagement with the receptacle. The glider may be formed using a first section. The second section may slide over the glider when the lug of the coupling device is brought into engagement with the receptacle.

In some examples, when the first section is separated from the second section, the rip line may have a remnant of a torn or broken surface. In other examples, the rip line may have a clean edge, such as an edge formed by molding. For example, when the bonding device is separated to separate the first section from the second section, the edges on the first and second sections may be clean and may have no trace or remnant of a torn or broken surface.

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 welded or by gluing.

In some examples, the proximal end of the first segment may have tabs extending proximally from the proximal end of the first segment when the first segment is separated from the second segment. In other examples, the proximal end of the first segment may have tabs each with at least one receptacle extending proximally from the proximal end of the first segment.

Aspects of the present disclosure also relate to a needle assembly comprising: a catheter hub; a catheter tube extending from a distal end of the catheter hub; a needle at least partially disposed in the catheter tube body; a needle hub attached to the needle; a needle cap positioned to cover the needle and the catheter tube body; the needle cap comprising a first section and a second section, the first section comprising an elongated sleeve having a hole, and the second section comprising a base portion comprising an upper opening and a lower opening and covering at least a portion of the 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 the first section is separated from the second section along a detachment line.

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

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

The needle assembly may further include a tab on the proximal end of the second segment, the tab being sized and shaped to facilitate removal of the second segment 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.

The needle assembly comprises a joining device which joins the first section to the second section at a line of severance.

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

Needle assembly wherein the rip line may be narrow or wavy.

Needle assembly wherein the engagement device may be guided by one or more sliders.

The needle assembly may include a receptacle that is positionable on a tab extending at the proximal end of the first section.

Yet another feature of the present disclosure is a method of stabilizing a puncture site, the method comprising: separating a first section of a protective cap from a second section along a tear line; the first section comprising an elongated sleeve having a hole, and the second section having a base portion comprising two side walls and including a top wall; placing the second section overlying a catheter hub such that the base portion of the second section covers at least a portion of the catheter hub; and securing the base portion using an adhesive to prevent inadvertent movement.

The method may further include securing two wings using 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 segment.

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

The method, wherein the rip line 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.

Yet another feature of the present disclosure includes 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 including a first section and a second section; the first section having a hole for positioning the needle shaft therein, and the second section including a base covering at least a portion of the needle hub; and a rip line formed between the first section and the second section; and wherein the rip 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 for stabilizing a puncture site. The method may include: separating a protective cap along a tear line into a first section and a second section; the first section including an elongated sleeve having a hole, and the second section including a base portion including two side walls and a top wall; placing the second section overlying a catheter hub such that the base portion of the second section covers at least a portion of the catheter hub; and securing the base portion using an adhesive to prevent inadvertent movement.

BRIEF DESCRIPTION OF THE DRAWINGS

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

FIG1A shows a perspective view of the device with the protective cap still attached;

FIG1B shows a partially exploded perspective view of the apparatus of FIG1A ;

FIG2 shows a top view of the device with the stabilization element;

FIG3 shows a side view of the device of FIG2 ;

FIG4A shows a side view of an embodiment of the device just prior to separation;

FIG4B shows a side view of an embodiment of the device after separation;

FIG5 shows a perspective view of a second section of the device;

FIG6 shows a top view of the second section attached to the catheter hub; and

FIG7 shows a perspective view of an embodiment of a device with a dressing;

FIG8 shows the fixing means which is part of the protective cap after the first section of the cap has been removed;

9A-9D show alternative protective caps from different perspectives and in different cross-sections;

10A-10D illustrate alternative protective caps from different perspectives and in different cross-sections.

DETAILED DESCRIPTION

The specific embodiments described below in connection with the accompanying drawings are intended as descriptions of presently preferred embodiments of needle assemblies provided in accordance with aspects of the devices, systems, and methods of the present invention, and are not intended to represent the only forms in which the devices, systems, and methods of the present invention may be constructed or utilized. This description describes the features and steps for constructing and using embodiments of the devices, systems, and methods of the present invention in connection with the embodiments shown. However, it is to be understood that the same or equivalent functions and structures may be achieved by different embodiments, which are also intended to be included within the spirit and scope of the present disclosure. Like reference numerals are intended to indicate like or similar elements or features as indicated elsewhere herein.

FIG1A shows a perspective view of a needle assembly 500, which includes a needle-covered catheter assembly 120 and a cover or cap 5, which is typically frictionally and/or positively engaged to the catheter assembly and removable from the catheter assembly. The cover or cap 5 can be used to cover a needle 15 having a sharp tip or distal tip 37 and act as a protective cap to shield the needle 15 until use. In an example, the cover 5 may include two or more sections 10, 20 that are joined together, for example, integrally formed or mechanically secured to one another. When placed over the catheter assembly 120 before use (e.g., when the assembly is enclosed in a plastic sheath or vacuum bag), the first section 10 typically covers the needle 15 and catheter tubing 76 of the catheter assembly 120. The needle 15 has a shaft 23, a tip 37, and optionally a contoured portion for interacting with a needle guard, such as a corrugation or ridge 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 can engage or frictionally grip the catheter hub 75 to secure the cap 5 to the catheter assembly 120. In some examples, the second section 20 can grip a flange or lug on the needle hub 35. As discussed further below, the second section 20 can be referred to as an anchor or fixation device, and the first section 10 can be referred to as a protective sleeve. After the cap 5 is removed from the catheter assembly 120, the two sections 10, 20 can be separated or detached from each other at the detachment line 30, which is located between the distal and proximal ends of the cap 5. The detachment line 30 can be a fragile or weakened section and can be configured to tear or separate easily under the action of relatively low force. The tear line 30 can be a perforation, a thin 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 causes it to split into at least two separate sections 10, 20 when a sufficient level of force is applied. The tear line 30 can be linear or straight, curved, zigzag, or a combination thereof. Alternatively, as discussed further below, the at least two separate sections 10, 20 can be removably connected using a snap fit arrangement, an engagement arrangement, a detent arrangement, or a combination thereof, and the tear line 30 between the two sections 10, 20 can be separated by releasing the snap fit, releasing the engagement arrangement, or releasing the detent.

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

The first section 10 of the cap 5 is generally elongated and has an aperture for receiving and covering the needle 15 and catheter tubing 76, thereby protecting the user from accidental needle sticks prior to use and/or protecting the plastic sheath when the needle device 500 is positioned within the packaging. As shown, the first section 10 is generally cylindrical in cross-section, but other shapes, such as conical, oval, composite, irregular, polygonal, etc., are also possible. The distal tip 12 of the first section 10, sometimes also referred to as the end, is shown. The distal tip 12 is configured to cover the tip of the needle and has a flat wall surface with one or more optional openings for venting. The main body 14 of the first section 10 is sized and shaped to cover the length of the needle 15 and catheter tubing 76. The length of the first section 10 can be greater than the length of the needle 15 protruding from the catheter hub 75 to ensure sufficient clearance, space, or clearance from the needle tip 37. Utilizing a relatively long length for the first section 10 allows the cap 5 to be used with various assemblies having different needle lengths. In some examples, the cap 5 is configured to cover or accommodate a needle without a catheter tubing, such as an injection needle or an epidural needle. The exact portion of the needle and catheter tubing length covered by the body portion 14 can vary and 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 that transitions 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, which is attached to the 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 sleeve 17 and a 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 at the distal end 18 of the proximal body portion ( FIG. 2 ). The shoulder 33 rises to a larger cross-sectional dimension, and this larger dimension remains constant toward the proximal end, though varying dimensions are 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, sometimes simply referred to as the "base." The tapered proximal body portion 16 has two sidewalls 22 , 24 that transition from vertical to horizontal at a top 122 , meeting at a seam 124 . The tapered proximal body portion 16 has an opening 26 ( FIG. 1A ) positioned opposite the top 122 . In some examples, the seam 124 is simply a raised section or crest at the top 122. In other examples, the seam is omitted or is not easily noticeable. This configuration of sidewalls 22, 24 with underside opening 26 is configured to accommodate attachment of the cap 5 to the remainder of the catheter assembly and removal of the cap 5 from the remainder of the catheter assembly to disengage it from engagement with the catheter hub 75, the needle hub 35, or both.

When positioned over the catheter assembly 120, the second segment 20 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 segment 20 has additional functions not previously recognized, appreciated, or disclosed in any known prior art. In the present disclosure, the second segment 20, in addition to serving as a cover for the catheter hub and/or needle hub, also serves as a stabilization platform. The second segment 20 includes a base portion 40 sized and shaped to cover the catheter hub 75, a top surface segment or upper panel 56, and an opening 105 ( FIG. 5 ) opposite the top surface segment 56. In other embodiments, the base portion 40 is sufficiently sized to cover all or part of the needle hub 35, the catheter hub 75, or both. After a successful venipuncture and placement of the catheter hub 76 within a blood vessel, the second segment 20 can be separated from the first segment 10 and repositioned over the catheter hub 75 without the first segment 10 to stabilize the puncture site. The second section 20 can be provided with an adhesive, have an adhesive applied to it, or both, to anchor a 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 (e.g., a Seldinger needle), the second section 20 can be placed over the needle hub to stabilize it.

FIG1B shows the cap 5 separated from the catheter assembly 120 of FIG1A , for example, before use. The needle 15, needle hub 35, catheter tubing 76, and catheter hub 75 remain connected for venipuncture. The cap 5 of FIG1A and FIG1B may include wings or stabilizing elements 42, 44 extending laterally of the second section 20, as discussed further below.

Figure 2 shows a top view of the cover 5 of Figures 1A and 1B with wings 42 and 44. A 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 tear line 30 is a perforation formed during the injection molding process to form the cover. It can be made from many known thermoplastics and is typically manufactured using a translucent finish with a transparent cover (although opaque covers are also contemplated). Alternatively, the perforation line can be formed during a post-molding process, for example, using laser technology to weaken a section of the protective cover to facilitate separation. In some examples, the tear line 30 comprises 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, as discussed further below, the first and second sections 10, 20 can be separated along the tear line by removing or releasing a mechanical interengagement. Including the detachment 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, unraveling, removing, or twisting. The detachment process will be discussed in more detail below.

Extending laterally from either side 130, 132 of the base portion 40 are stabilizing elements 42, 44, which may also be referred to as wings. In an example, the stabilizing elements 42, 44 are flat and flexible so that they can be folded around the base section 40 when enclosed in the soft cover and can be unfolded to form anchor points for attaching the second section 20, which is covered by the catheter hub, to the patient using one or more pieces of medical tape, as further discussed with reference to FIG8 . The stabilizing elements 42, 44 can be embodied as wings having any number of features formed thereon, including openings or holes, ridges or protrusions for gripping, and/or design features for aesthetics. As an alternative to, or in addition to, using an external or separate medical tape, each stabilizing element 42, 44 may include an adhesive layer 26 (FIG. 3) with a peelable release layer on the bottom surface 48 (FIG. 3) of each element 42, 44, or may be devoid of any adhesive layer. The pliability of the stabilizing elements 42, 44 allows them to be folded over the base portion 40 so as to be folded about the longitudinal axis of the cap and wrapped around the top surface of the second section 20 during packaging and storage of the catheter assembly, as discussed further below. In other embodiments, the stabilizing elements 42, 44 are relatively stronger, stiffer, or more rigid so that they do not fold over the second section 20 during packaging and storage. Alternatively, the soft cover may be sized and shaped to receive the assembly with the wings in an extended position, as shown. In still other embodiments, the stabilizing elements are omitted and the medical tape is applied directly to the base portion 40 of the second section 20 without any stabilizing elements. In another embodiment, stabilizing element or wing portion 42,44 is made of the soft material without any sticky material. In another embodiment, fixture 20 and wing portion 42,44 are made of the single soft material through being molded together into one piece, for example, made of soft plastic. The fixture 20 and wing portion 42,44 formed into one piece by soft material allow fixture 20 and wing portion 42,44 to bend, flex or otherwise be soft to match to medical device or against patient match. In another embodiment, fixture and wing portion are made of the single hard material (for example hard plastic) through being molded together into one piece. Each wing portion 42,44 can be formed as a single piece structure, and this single piece structure is formed to base portion 40, or each wing portion 42,44 can be formed by two or more parts, and these two or more parts use adhesive, welding or other bonding technology to combine together.

The wings 42, 44 can be formed to have any size and shape that will allow a user to apply or otherwise secure the wings 42, 44 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 edge 62, 64 of each stabilizing element 42, 44. The frangible or adjustable portions 52, 54 allow the wings 42, 44 to be resized (e.g., reduced in size) to match the size of an area on the patient or the patient where a catheter is placed. In still other examples, the wings 42, 44 may include multiple lines of frangible or adjustable threads to allow for various resizing options, depending on which frangible thread is selected 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 on a top surface portion or upper panel 56 of base portion 40 near proximal end 58 of base portion 40. Slot or opening 55 is configured for mechanical engagement between second section 20 and catheter hub 75, as will be discussed in greater detail below.

FIG3 shows a side view of the cover 5 of FIG2 . Shown in this view of the cover 5 is the first sidewall 22 of the proximal body portion 16 of the first section 10. The first sidewall 22 has a wall surface that tapers outward from the longitudinal axis and from the maximum outer dimension of the tubular portion 60. The tapered proximal body portion 16 includes a corresponding second sidewall 24 ( FIG1A ) on the opposite side. The first sidewall 22 of the tapered proximal portion 16 transitions to a top surface 122 ( FIG3 ) that connects to the second sidewall 24. A ridge 62 is provided at the top surface 122, defining the centerline of the top surface extending along the longitudinal axis. An upper panel 56, which can be flat or have a curved portion, is positioned at the proximal end of the second section 20 and forms the top of the base portion 40. A lug 64 is formed on the flat panel 56 at the proximal end 58. In one example, the lug 64 is a vertical wall, although tapered walls are also contemplated. The lugs 64 provide leverage for the user to grasp when removing the cover 5 from the catheter assembly or needle device before use. The lugs 64 also provide the user with additional leverage to detach, advance, release, and/or rotate the proximal body portion 16 of the first section 10 to detach from the catheter assembly, thereby removing the cap from the catheter assembly. Additionally, the lugs 64 provide stability to the stabilizing elements 42, 44 when folded onto the top panel 56 of the base portion 40 of the second section 20 during packaging and storage. In other embodiments, the lugs 64 may be omitted, made taller, shorter, wider, or 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 stabilizing elements 42, 44 ( FIG. 2 ) to the patient. In still other embodiments, a dressing may be used in place of medical tape or in combination with medical tape. The dressing is discussed in more detail below.

FIG4A shows the cap 5 after removal from the needle and needle hub, and FIG4B shows the first section 10 of the cap 5 separated from the second section 20 at a tear-off point or line 30. After a successful venipuncture using the catheter assembly 120 of FIG1A and FIG1B and the needle and needle hub are removed from the catheter tubing and catheter hub, the cap 5 can be used to stabilize the catheter hub 75 on the patient to stabilize and/or secure the catheter hub and the puncture site. As shown in FIG4B , the cap 5 is separated into two sections 10, 20 along the tear-off line 30. The tear-off line 30 is fragile and is configured to be easily torn or separated. The tear-off line 30 can be a perforation, a thin section that is more weakened than the rest of the cover, a groove, or any other structural design that will cause inherent weakness and cause the cap 5 to split or break into at least two separate sections 10, 20 at the tear-off line when a sufficient level of force is applied. Alternatively, the first and second sections 10, 20 can be mechanically secured to each other at the tear line 30 and can be separated from each other by unfastening, releasing, undoing, or otherwise separating the mechanical connection at the tear line 30. Preferably, the tear line 30 is configured so that the level of force that occurs accidentally will not be sufficient to cause the cap to split or separate into the two sections 10, 20. However, the level of force required to separate the cap at the tear line 30 can be adjusted, for example, by increasing the gap or length between the perforations or increasing or decreasing the material thickness of the weakened section without departing from the scope of the present disclosure. To cause the two sections 10, 20 to separate, the user applies force to increase 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 develops to the top of the cap 5. At that point, the user applies force to tear the material along the tear line 30 across the top of the cap 5. Of course, other means of separating the first section from the second section can be used, such as using scissors.

After separation, the first segment 10 can be discarded or reused. If the first segment 10 is detached from the second segment 20, the second segment 20 can be reused as a securing device. In an example, the second segment 20 includes a base portion 40, a sidewall 130, and an opening 105 on a side opposite the top surface 56. The second segment 20 is sized and shaped to couple with the catheter hub 75 ( FIG. 1 ) to secure the catheter hub after a venipuncture. By securing the catheter hub 75, undesirable movement of the puncture site due to movement of the catheter hub can be prevented. Therefore, 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 the cap is removed from the needle. For example, the second segment 20 can be separated from the first segment 10 and retained for reuse, such as by placing the second segment 20 over the catheter hub to stabilize it. If stabilizing elements 42, 44 are included and 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 removing the removable liner 78 from each adhesive pad 46, the soft adhesive pads 46 provided with the wings can be used to secure the wings or stabilizing elements 42, 44 to the patient. In other embodiments, external medical tape is used to secure the stabilizing elements 42, 44 to the patient. In still other examples, both the adhesive pads 46 on the wings 42, 44 and the external medical tape are used to secure the second segment 20 to the patient. A mechanical engagement or connection between the catheter hub 75 and the base portion 40 can also be used to secure the second segment 20 to the patient. For example, tabs or threads on the catheter hub can protrude through slots 55 (FIGS. 2 and 5) on the second segment 20 to mechanically engage the catheter hub and the second segment 20, which can be referred to as anchors or securing means.

FIG5 shows the second segment, anchor, or fixation device 20 after being separated from the first segment 10 and oriented so that the stabilizing 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 FIG5 , which generally corresponds to its normal use position when positioned over a catheter hub 75. FIG6 shows the second segment 20 positioned over a catheter hub 75, for example, after a successful venipuncture and the catheter tubing 76 has been placed in a patient's blood vessel. To ensure that the base portion 40 of the anchor 20 is aligned with the catheter hub 75 and that the two are engaged to provide sufficient stability to the catheter hub, a slot or opening 55 on the top surface section 56 of the base portion 50 just distal to the lug 64 can be positioned around an engagement element 82, which can be a protrusion, lug, rib, or threaded portion formed on the catheter hub 75. In some embodiments, the positions of the slot/opening 55 and the protrusion 82 can be reversed, i.e., the catheter hub includes a notch and the base portion 40 includes a protrusion that is configured to protrude into the notch on the catheter hub. The height of the two side walls 130, 132 can be selected so that at least a portion of the inner wall of the top surface segment 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 side walls 130, 132 are selected so that the inner wall of the top surface segment 56 does not push against the catheter hub. By positioning the second segment 20 overlying the catheter hub 75, the catheter hub is protected or secured against undesirable movement or at least prevented from excessive movement. In some embodiments, the engagement element 82 can include a simple vertical tab or rib. In another example, the engagement element 82 can include a tab having a specific shape 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 similar to a rib, barb, or hook. When the hook 92 is placed through the slot 55, this allows the engagement member or element 82 to form a more secure mechanical engagement with the slot 55. In this way, the catheter hub 75 is mechanically engaged to the base portion 40 and the fixation is not based solely on adhesive or tape.

In other embodiments, the engagement element 82 may comprise a single "T" shaped element, wherein the crossbar of the "T" shaped element compresses when it enters the slot 55 and then expands once the crossbar exits the slot 55. Still other alternative engagement elements 82 may comprise a rod extending from the catheter hub 75, the rod being topped with a hemispherical structure, similar to the head of a mushroom. The hemispherical structure will radially compress when entering the slot 44 (which may be circular), and then expand back when exiting the slot. Slits or slots may be provided on the hemispherical structure to facilitate flexion. In yet another embodiment, a rotatable latch may be used to secure the catheter hub 75 to the anchor portion 20. In yet another example, the engagement element 82 is sized so that it frictionally engages the slot 55 or is an interference fit within the slot 55.

FIG7 illustrates an alternative embodiment in which an adhesive pad is used to secure the stabilizing elements 42, 44 of the anchor portion 20 to the patient, which can be the same or substantially the same as the anchor portion discussed elsewhere herein. In this embodiment, a "U"-shaped adhesive pad or dressing 146 can be used to attach the stabilizing elements 42, 44 extending from the base portion 40 to the patient 110. The adhesive pad or dressing 146 is "U"-shaped, with the base 180 of the "U" positioned distal to where the catheter hub 76 enters the patient 110. The two sides 182, 184 of the "U" 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 can be narrower than the width of the stabilizing elements, can be the same width as the stabilizing elements, or can be wider than the width of the stabilizing elements. The two side portions 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 so that it covers all of the stabilization elements 42, 44. In other embodiments, the dressing may leave some of one or both stabilization elements 42, 44 exposed and uncovered. In still other embodiments, the dressing 146 may be positioned just off the side or proximal edges of the stabilization elements 42, 44. Other embodiments may use dressings of other shapes, including "V" shaped dressings, "D" shaped dressings, or dressings extending from each stabilization element 42 in a variety of shapes, including square, rectangular, triangular, and semicircular.

In some embodiments, the dressing 146 is integrally formed with the base portion 40 of the second segment or anchor 20, and the stabilizing elements 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 inserting the catheter, the user separates the two segments 10, 20 of the protective cap 5 and then places the base portion 40 of the second segment 20 onto the catheter hub 75. The user removes the release liner 78 from the dressing 146 and applies it to the patient's skin. The dressing may be made of a soft material to provide additional stabilization by firmly adhering to the patient's skin while providing a larger surface area of contact with the catheter. In one example, the sides 182, 184 of the dressing 146 are unfolded from the sides of the base portion 40, the release liner removed from each side, and then securely applied to the patient's skin.

FIG8 shows an exemplary embodiment of a second segment, fixture, or anchor 20 separated from a first segment 10, wherein stabilizing elements 42, 44 (e.g., wings) are folded over the base portion 40 of the second segment 20. The stabilizing elements 42, 44 can be folded as shown to facilitate packaging of the cap 5 having the anchor 20 of FIG8 , mounted over a needle device or catheter assembly. The folded configuration of the wings provides a relatively smaller width profile and, therefore, a relatively smaller footprint for the needle device. The stabilizing elements 42, 44 are each shown with an adhesive pad 46 and a release liner 78. The stabilizing elements 42, 44 can be flexible and maintained in the folded configuration shown without any restraint or retention measures. In other examples, a repositionable adhesive or other removable adhesive can be used to retain the distal end of each wing in the folded state.

9A shows a protective cap 5 having a first section 10 and a second section 20, which is similar to other protective caps discussed elsewhere herein. In this embodiment, the first and second sections 10, 20 can be mechanically fixed to each other along the detachment line 30 or near the detachment line 30 using a binding device. The binding device for binding the first section 10 to the second section 20 can be included in the interior of the cap 5 so that a smooth outer profile is provided on the outside for aesthetic purposes. In the example, the size and shape of the binding device are configured to provide a smooth outer transition at two outer binding surfaces 220a, 220b at or near the detachment line 30. Markings or traces 232 can be provided on the outside of the base section 40 to help align the components of the binding device, as further discussed below.

FIG9B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction of the cap shown in FIG9A . In an example, two engagement devices 222 (only one shown) may be provided within the interior of the cap 5. For example, one engagement device 222 may be provided on each longitudinal half of the cap, such as along a section of one of the inner sidewall 224 of the base portion 40 and the inner sidewall 226 of the proximal body portion 16 of the first section 10. Each engagement device 222 may include one or more protrusions 228 for engaging corresponding receptacles 230, similar to a hole and pin or snap-fit configuration. In the illustrated embodiment, two protrusions 228 are provided with the base portion 40 for each engagement device 222, projecting into two receptacles 230 provided with the proximal body portion 16. However, the positions of the protrusions and receptacles may be reversed, i.e., with the protrusions being provided with the proximal body portion 16. The engagement between each pair of protrusions 228 and receptacles 230 may be a tight fit, a friction fit, or an interference fit. In an example, the two protrusions 228 may be formed directly with the inner sidewall 224 of the second segment 20 , and the receptacle 230 may be provided on a lug or extension 234 extending from the end of the first segment 10 .

To separate the first section 10 from the second section 20, the user simply spreads the two side walls 130, 132 away from each other or presses the two side walls 130, 132 together, depending on whether the tab 228 is with the base portion 40 or the proximal body portion 16. This will cause the tab 228 to separate from the receptacle 230, allowing the first and second sections 10, 20 to separate from each other at the rip line 30. Once separated, the second section 20 can 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 .

Figure 9D shows the second section 20 of the cap 5 of Figure 9A separated from the first section 10. In an example, the protrusion 228 is embodied as a short stake or post. In other examples, the protrusion 228 is embodied as a dome-shaped section or a partial sphere, as shown in Figure 9D.

FIG10A 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 can be mechanically secured to each other along or near the detachment line 30 using a bonding device 222. As shown, the detachment line of this embodiment may not be straight, for example, it may be curved or wavy. The bonding device 222 for bonding the first section 10 to the second section 20 may be included within the wall surface of the cap 5 and meshed so that a smooth profile is provided on the exterior for aesthetic reasons.

In an example, the coupling device 222 may include a plurality of interlocking tabs 240 that engage a plurality of corresponding receptacles 246, similar to the interlocking tabs on a jigsaw puzzle. In the example shown, there are four tabs 240 to engage four corresponding receptacles 246. In other examples, there may be fewer than four tabs 240, such as three or two tabs, or there may be more than four tabs, such as five or six or more tabs, 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.

FIG10B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction shown in FIG10A. In an example, a coupling device 222 comprising a plurality of interlocking tabs and receptacles may be formed (e.g., molded) directly at the proximal end of the proximal body portion 16 and the distal end of the base member 40. The tabs and receptacles may be snapped together to mate as shown in FIG10A and FIG10B.

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

To separate the first section 10 from the second section 20, the user simply spreads the two sidewalls 130, 132 of the base member 40 away from each other and lifts 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 section 10 and the second section 20 along the separation line 30. This will cause the tabs 240 to separate from the receptacles 240 to allow the first and second sections 10, 20 to separate from each other at the detachment line 30. Once separated, the second portion 20 can be used to secure the catheter hub, as discussed elsewhere herein. In other examples, the first and second sections 10, 20 can be simply pulled in opposite directions to separate the first and second sections 10, 20 along the detachment 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 needle devices and caps, and components thereof, 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 variations will be apparent to those skilled in the art. Furthermore, although the cap is described in connection with the catheter assembly, the same cap can be used on other needle devices, such as hypodermic needles, Seldinger needles, and epidural needles, to name a few. Therefore, it is to be understood that the protective cap and catheter assembly and their components constructed according to the principles of the disclosed apparatus, systems, and methods may be embodied differently than specifically described herein. The present disclosure is further defined in the appended claims.

Caps for needles and catheters

Technical Field

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

Background Art

Catheters are often used for various infusion therapies, including infusing fluids into a patient, withdrawing blood from a patient, or measuring various parameters of a patient's vascular system. The catheter is typically connected to a catheter connector that is suitable for attaching IV tubing to the catheter. The needle used with the catheter tubing has a sharp tip that is typically covered by a cap during packaging of the catheter assembly. The sharp tip of such a needle poses a safety risk that is often overcome by including a removable cap covering the needle tip and at least a portion of the assembly in a thermoplastic sheath or vacuum bag. After removing the packaging material, the cap is often removed and discarded. After the catheter tubing is placed in the patient's blood vessel and before or after the catheter hub is connected to the IV fluid source, the hub is secured to protect the entry site from inadvertent movement, for example by affixing the catheter hub to the patient's skin.

Summary of the 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 cover the needle shaft, the protective cap comprising a first section and a second section; the first section having a hole for positioning the needle shaft therein, and the second section comprising 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 capable of breaking 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, wherein the protective cap can be separated along a tear line into at least two distinct segments, namely a first segment and a second segment, and wherein one of the two segments can be reused as a securing device.

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

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

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

When the 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 remain folded without the aid of an adhesive.

The 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 cross and each arm may include a distal wall.

The second section of the cap may have two side walls and 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 elongated tubular body or cylindrical portion and an expanded or enlarged proximal body portion. The elongated tubular body and the enlarged proximal body portion may have a hole for accommodating a needle.

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

The needle assembly may include a wing having an adjustable portion, such as a portion that can be trimmed or removed to change the shape of the wing.

The needle assembly may include means for attaching the first segment to the second segment at the line of detachment. The means may include a perforation, a weakened portion, or one or more mechanical interengagements. The line of detachment may be straight, curved, or wavy. The mechanical interengagements, which may also be referred to as coupling means, may include a protrusion and receptacle combination or a lug and receptacle combination, similar to the interlocking lugs on a jigsaw puzzle. The protrusions may be posts, rounded segments, or hemispherical segments.

In some examples, the receptacle can be formed on a tab, and the tab can extend beyond the proximal end of the first segment or can extend beyond the distal end of the second segment.

A glider may be used to help guide the lug into engagement with the receptacle. The glider may be formed using a first section. The second section may slide over the glider when the lug of the coupling device is brought into engagement with the receptacle.

In some examples, when the first section is separated from the second section, the rip line may have a remnant of a torn or broken surface. In other examples, the rip line may have a clean edge, such as an edge formed by molding. For example, when the bonding device is separated to separate the first section from the second section, the edges on the first and second sections may be clean and may have no trace or remnant of a torn or broken surface.

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 welded or by gluing.

In some examples, the proximal end of the first segment may have tabs extending proximally from the proximal end of the first segment when the first segment is separated from the second segment. In other examples, the proximal end of the first segment may have tabs each with at least one receptacle extending proximally from the proximal end of the first segment.

Aspects of the present disclosure also relate to a needle assembly comprising: a catheter hub; a catheter tube extending from a distal end of the catheter hub; a needle at least partially disposed in the catheter tube body; a needle hub attached to the needle; a needle cap positioned to cover the needle and the catheter tube body; the needle cap comprising a first section and a second section, the first section comprising an elongated sleeve having a hole, and the second section comprising a base portion comprising an upper opening and a lower opening and covering at least a portion of the 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 the first section is separated from the second section along a detachment line.

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

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

The needle assembly may further include a tab on the proximal end of the second segment, the tab being sized and shaped to facilitate removal of the second segment 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.

The needle assembly comprises a joining device which joins the first section to the second section at a line of severance.

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

Needle assembly wherein the rip line may be narrow or wavy.

Needle assembly wherein the engagement device may be guided by one or more sliders.

The needle assembly may include a receptacle that is positionable on a tab extending at the proximal end of the first section.

Yet another feature of the present disclosure is a method of stabilizing a puncture site, the method comprising: separating a first section of a protective cap from a second section along a tear line; the first section comprising an elongated sleeve having a hole, and the second section having a base portion comprising two side walls and including a top wall; placing the second section overlying a catheter hub such that the base portion of the second section covers at least a portion of the catheter hub; and securing the base portion using an adhesive to prevent inadvertent movement.

The method may further include securing two wings using 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 segment.

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

The method, wherein the rip line 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.

Yet another feature of the present disclosure includes 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 including a first section and a second section; the first section having a hole for positioning the needle shaft therein, and the second section including a base covering at least a portion of the needle hub; and a rip line formed between the first section and the second section; and wherein the rip 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 for stabilizing a puncture site. The method may include: separating a protective cap along a tear line into a first section and a second section; the first section including an elongated sleeve having a hole, and the second section including a base portion including two side walls and a top wall; placing the second section overlying a catheter hub such that the base portion of the second section covers at least a portion of the catheter hub; and securing the base portion using an adhesive to prevent inadvertent movement.

BRIEF DESCRIPTION OF THE DRAWINGS

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

FIG1A shows a perspective view of the device with the protective cap still attached;

FIG1B shows a partially exploded perspective view of the apparatus of FIG1A ;

FIG2 shows a top view of the device with the stabilization element;

FIG3 shows a side view of the device of FIG2 ;

FIG4A shows a side view of an embodiment of the device just prior to separation;

FIG4B shows a side view of an embodiment of the device after separation;

FIG5 shows a perspective view of a second section of the device;

FIG6 shows a top view of the second section attached to the catheter hub; and

FIG7 shows a perspective view of an embodiment of a device with a dressing;

FIG8 shows the fixing means which is part of the protective cap after the first section of the cap has been removed;

9A-9D show alternative protective caps from different perspectives and in different cross-sections;

10A-10D illustrate alternative protective caps from different perspectives and in different cross-sections.

DETAILED DESCRIPTION

The specific embodiments described below in connection with the accompanying drawings are intended as descriptions of presently preferred embodiments of needle assemblies provided in accordance with aspects of the devices, systems, and methods of the present invention, and are not intended to represent the only forms in which the devices, systems, and methods of the present invention may be constructed or utilized. This description describes the features and steps for constructing and using embodiments of the devices, systems, and methods of the present invention in connection with the embodiments shown. However, it is to be understood that the same or equivalent functions and structures may be achieved by different embodiments, which are also intended to be included within the spirit and scope of the present disclosure. Like reference numerals are intended to indicate like or similar elements or features as indicated elsewhere herein.

FIG1A shows a perspective view of a needle assembly 500, which includes a needle-covered catheter assembly 120 and a cover or cap 5, which is typically frictionally and/or positively engaged to the catheter assembly and removable from the catheter assembly. The cover or cap 5 can be used to cover a needle 15 having a sharp tip or distal tip 37 and act as a protective cap to shield the needle 15 until use. In an example, the cover 5 may include two or more sections 10, 20 that are joined together, for example, integrally formed or mechanically secured to one another. When placed over the catheter assembly 120 before use (e.g., when the assembly is enclosed in a plastic sheath or vacuum bag), the first section 10 typically covers the needle 15 and catheter tubing 76 of the catheter assembly 120. The needle 15 has a shaft 23, a tip 37, and optionally a contoured portion for interacting with a needle guard, such as a corrugation or ridge 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 can engage or frictionally grip the catheter hub 75 to secure the cap 5 to the catheter assembly 120. In some examples, the second section 20 can grip a flange or lug on the needle hub 35. As discussed further below, the second section 20 can be referred to as an anchor or fixation device, and the first section 10 can be referred to as a protective sleeve. After the cap 5 is removed from the catheter assembly 120, the two sections 10, 20 can be separated or detached from each other at the detachment line 30, which is located between the distal and proximal ends of the cap 5. The detachment line 30 can be a fragile or weakened section and can be configured to tear or separate easily under the action of relatively low force. The tear line 30 can be a perforation, a thin 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 causes it to split into at least two separate sections 10, 20 when a sufficient level of force is applied. The tear line 30 can be linear or straight, curved, zigzag, or a combination thereof. Alternatively, as discussed further below, the at least two separate sections 10, 20 can be removably connected using a snap fit arrangement, an engagement arrangement, a detent arrangement, or a combination thereof, and the tear line 30 between the two sections 10, 20 can be separated by releasing the snap fit, releasing the engagement arrangement, or releasing the detent.

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

The first section 10 of the cap 5 is generally elongated and has an aperture for receiving and covering the needle 15 and catheter tubing 76, thereby protecting the user from accidental needle sticks prior to use and/or protecting the plastic sheath when the needle device 500 is positioned within the packaging. As shown, the first section 10 is generally cylindrical in cross-section, but other shapes, such as conical, oval, composite, irregular, polygonal, etc., are also possible. The distal tip 12 of the first section 10, sometimes also referred to as the end, is shown. The distal tip 12 is configured to cover the tip of the needle and has a flat wall surface with one or more optional openings for venting. The main body 14 of the first section 10 is sized and shaped to cover the length of the needle 15 and catheter tubing 76. The length of the first section 10 can be greater than the length of the needle 15 protruding from the catheter hub 75 to ensure sufficient clearance, space, or clearance from the needle tip 37. Utilizing a relatively long length for the first section 10 allows the cap 5 to be used with various assemblies having different needle lengths. In some examples, the cap 5 is configured to cover or accommodate a needle without a catheter tubing, such as an injection needle or an epidural needle. The exact portion of the needle and catheter tubing length covered by the body portion 14 can vary and 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 that transitions 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, which is attached to the 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 sleeve 17 and a 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 at the distal end 18 of the proximal body portion ( FIG. 2 ). The shoulder 33 rises to a larger cross-sectional dimension, and this larger dimension remains constant toward the proximal end, though varying dimensions are 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, sometimes simply referred to as the "base." The tapered proximal body portion 16 has two sidewalls 22 , 24 that transition from vertical to horizontal at a top 122 , meeting at a seam 124 . The tapered proximal body portion 16 has an opening 26 ( FIG. 1A ) positioned opposite the top 122 . In some examples, the seam 124 is simply a raised section or crest at the top 122. In other examples, the seam is omitted or is not easily noticeable. This configuration of sidewalls 22, 24 with underside opening 26 is configured to accommodate attachment of the cap 5 to the remainder of the catheter assembly and removal of the cap 5 from the remainder of the catheter assembly to disengage it from engagement with the catheter hub 75, the needle hub 35, or both.

When positioned over the catheter assembly 120, the second segment 20 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 segment 20 has additional functions not previously recognized, appreciated, or disclosed in any known prior art. In the present disclosure, the second segment 20, in addition to serving as a cover for the catheter hub and/or needle hub, also serves as a stabilization platform. The second segment 20 includes a base portion 40 sized and shaped to cover the catheter hub 75, a top surface segment or upper panel 56, and an opening 105 ( FIG. 5 ) opposite the top surface segment 56. In other embodiments, the base portion 40 is sufficiently sized to cover all or part of the needle hub 35, the catheter hub 75, or both. After a successful venipuncture and placement of the catheter hub 76 within a blood vessel, the second segment 20 can be separated from the first segment 10 and repositioned over the catheter hub 75 without the first segment 10 to stabilize the puncture site. The second section 20 can be provided with an adhesive, have an adhesive applied to it, or both, to anchor a 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 (e.g., a Seldinger needle), the second section 20 can be placed over the needle hub to stabilize it.

FIG1B shows the cap 5 separated from the catheter assembly 120 of FIG1A , for example, before use. The needle 15, needle hub 35, catheter tubing 76, and catheter hub 75 remain connected for venipuncture. The cap 5 of FIG1A and FIG1B may include wings or stabilizing elements 42, 44 extending laterally of the second section 20, as discussed further below.

Figure 2 shows a top view of the cover 5 of Figures 1A and 1B with wings 42 and 44. A 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 tear line 30 is a perforation formed during the injection molding process to form the cover. It can be made from many known thermoplastics and is typically manufactured using a translucent finish with a transparent cover (although opaque covers are also contemplated). Alternatively, the perforation line can be formed during a post-molding process, for example, using laser technology to weaken a section of the protective cover to facilitate separation. In some examples, the tear line 30 comprises 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, as discussed further below, the first and second sections 10, 20 can be separated along the tear line by removing or releasing a mechanical interengagement. Including the detachment 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, unraveling, removing, or twisting. The detachment process will be discussed in more detail below.

Extending laterally from either side 130, 132 of the base portion 40 are stabilizing elements 42, 44, which may also be referred to as wings. In an example, the stabilizing elements 42, 44 are flat and flexible so that they can be folded around the base section 40 when enclosed in the soft cover and can be unfolded to form anchor points for attaching the second section 20, which is covered by the catheter hub, to the patient using one or more pieces of medical tape, as further discussed with reference to FIG8 . The stabilizing elements 42, 44 can be embodied as wings having any number of features formed thereon, including openings or holes, ridges or protrusions for gripping, and/or design features for aesthetics. As an alternative to, or in addition to, using an external or separate medical tape, each stabilizing element 42, 44 may include an adhesive layer 26 (FIG. 3) with a peelable release layer on the bottom surface 48 (FIG. 3) of each element 42, 44, or may be devoid of any adhesive layer. The pliability of the stabilizing elements 42, 44 allows them to be folded over the base portion 40 so as to be folded about the longitudinal axis of the cap and wrapped around the top surface of the second section 20 during packaging and storage of the catheter assembly, as discussed further below. In other embodiments, the stabilizing elements 42, 44 are relatively stronger, stiffer, or more rigid so that they do not fold over the second section 20 during packaging and storage. Alternatively, the soft cover may be sized and shaped to receive the assembly with the wings in an extended position, as shown. In still other embodiments, the stabilizing elements are omitted and the medical tape is applied directly to the base portion 40 of the second section 20 without any stabilizing elements. In another embodiment, stabilizing element or wing portion 42,44 is made of the soft material without any sticky material. In another embodiment, fixture 20 and wing portion 42,44 are made of the single soft material through being molded together into one piece, for example, made of soft plastic. The fixture 20 and wing portion 42,44 formed into one piece by soft material allow fixture 20 and wing portion 42,44 to bend, flex or otherwise be soft to match to medical device or against patient match. In another embodiment, fixture and wing portion are made of the single hard material (for example hard plastic) through being molded together into one piece. Each wing portion 42,44 can be formed as a single piece structure, and this single piece structure is formed to base portion 40, or each wing portion 42,44 can be formed by two or more parts, and these two or more parts use adhesive, welding or other bonding technology to combine together.

The wings 42, 44 can be formed to have any size and shape that will allow a user to apply or otherwise secure the wings 42, 44 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 edge 62, 64 of each stabilizing element 42, 44. The frangible or adjustable portions 52, 54 allow the wings 42, 44 to be resized (e.g., reduced in size) to match the size of an area on the patient or the patient where a catheter is placed. In still other examples, the wings 42, 44 may include multiple lines of frangible or adjustable threads to allow for various resizing options, depending on which frangible thread is selected 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 on a top surface portion or upper panel 56 of base portion 40 near proximal end 58 of base portion 40. Slot or opening 55 is configured for mechanical engagement between second section 20 and catheter hub 75, as will be discussed in greater detail below.

FIG3 shows a side view of the cover 5 of FIG2 . Shown in this view of the cover 5 is the first sidewall 22 of the proximal body portion 16 of the first section 10. The first sidewall 22 has a wall surface that tapers outward from the longitudinal axis and from the maximum outer dimension of the tubular portion 60. The tapered proximal body portion 16 includes a corresponding second sidewall 24 ( FIG1A ) on the opposite side. The first sidewall 22 of the tapered proximal portion 16 transitions to a top surface 122 ( FIG3 ) that connects to the second sidewall 24. A ridge 62 is provided at the top surface 122, defining the centerline of the top surface extending along the longitudinal axis. An upper panel 56, which can be flat or have a curved portion, is positioned at the proximal end of the second section 20 and forms the top of the base portion 40. A lug 64 is formed on the flat panel 56 at the proximal end 58. In one example, the lug 64 is a vertical wall, although tapered walls are also contemplated. The lugs 64 provide leverage for the user to grasp when removing the cover 5 from the catheter assembly or needle device before use. The lugs 64 also provide the user with additional leverage to detach, advance, release, and/or rotate the proximal body portion 16 of the first section 10 to detach from the catheter assembly, thereby removing the cap from the catheter assembly. Additionally, the lugs 64 provide stability to the stabilizing elements 42, 44 when folded onto the top panel 56 of the base portion 40 of the second section 20 during packaging and storage. In other embodiments, the lugs 64 may be omitted, made taller, shorter, wider, or 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 stabilizing elements 42, 44 ( FIG. 2 ) to the patient. In still other embodiments, a dressing may be used in place of medical tape or in combination with medical tape. The dressing is discussed in more detail below.

FIG4A shows the cap 5 after removal from the needle and needle hub, and FIG4B shows the first section 10 of the cap 5 separated from the second section 20 at a tear-off point or line 30. After a successful venipuncture using the catheter assembly 120 of FIG1A and FIG1B and the needle and needle hub are removed from the catheter tubing and catheter hub, the cap 5 can be used to stabilize the catheter hub 75 on the patient to stabilize and/or secure the catheter hub and the puncture site. As shown in FIG4B , the cap 5 is separated into two sections 10, 20 along the tear-off line 30. The tear-off line 30 is fragile and is configured to be easily torn or separated. The tear-off line 30 can be a perforation, a thin section that is more weakened than the rest of the cover, a groove, or any other structural design that will cause inherent weakness and cause the cap 5 to split or break into at least two separate sections 10, 20 at the tear-off line when a sufficient level of force is applied. Alternatively, the first and second sections 10, 20 can be mechanically secured to each other at the tear line 30 and can be separated from each other by unfastening, releasing, undoing, or otherwise separating the mechanical connection at the tear line 30. Preferably, the tear line 30 is configured so that the level of force that occurs accidentally will not be sufficient to cause the cap to split or separate into the two sections 10, 20. However, the level of force required to separate the cap at the tear line 30 can be adjusted, for example, by increasing the gap or length between the perforations or increasing or decreasing the material thickness of the weakened section without departing from the scope of the present disclosure. To cause the two sections 10, 20 to separate, the user applies force to increase 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 develops to the top of the cap 5. At that point, the user applies force to tear the material along the tear line 30 across the top of the cap 5. Of course, other means of separating the first section from the second section can be used, such as using scissors.

After separation, the first segment 10 can be discarded or reused. If the first segment 10 is detached from the second segment 20, the second segment 20 can be reused as a securing device. In an example, the second segment 20 includes a base portion 40, a sidewall 130, and an opening 105 on a side opposite the top surface 56. The second segment 20 is sized and shaped to couple with the catheter hub 75 ( FIG. 1 ) to secure the catheter hub after a venipuncture. By securing the catheter hub 75, undesirable movement of the puncture site due to movement of the catheter hub can be prevented. Therefore, 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 the cap is removed from the needle. For example, the second segment 20 can be separated from the first segment 10 and retained for reuse, such as by placing the second segment 20 over the catheter hub to stabilize it. If stabilizing elements 42, 44 are included and 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 removing the removable liner 78 from each adhesive pad 46, the soft adhesive pads 46 provided with the wings can be used to secure the wings or stabilizing elements 42, 44 to the patient. In other embodiments, external medical tape is used to secure the stabilizing elements 42, 44 to the patient. In still other examples, both the adhesive pads 46 on the wings 42, 44 and the external medical tape are used to secure the second segment 20 to the patient. A mechanical engagement or connection between the catheter hub 75 and the base portion 40 can also be used to secure the second segment 20 to the patient. For example, tabs or threads on the catheter hub can protrude through slots 55 (FIGS. 2 and 5) on the second segment 20 to mechanically engage the catheter hub and the second segment 20, which can be referred to as anchors or securing means.

FIG5 shows the second segment, anchor, or fixation device 20 after being separated from the first segment 10 and oriented so that the stabilizing 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 FIG5 , which generally corresponds to its normal use position when positioned over a catheter hub 75. FIG6 shows the second segment 20 positioned over a catheter hub 75, for example, after a successful venipuncture and the catheter tubing 76 has been placed in a patient's blood vessel. To ensure that the base portion 40 of the anchor 20 is aligned with the catheter hub 75 and that the two are engaged to provide sufficient stability to the catheter hub, a slot or opening 55 on the top surface section 56 of the base portion 50 just distal to the lug 64 can be positioned around an engagement element 82, which can be a protrusion, lug, rib, or threaded portion formed on the catheter hub 75. In some embodiments, the positions of the slot/opening 55 and the protrusion 82 can be reversed, i.e., the catheter hub includes a notch and the base portion 40 includes a protrusion that is configured to protrude into the notch on the catheter hub. The height of the two side walls 130, 132 can be selected so that at least a portion of the inner wall of the top surface segment 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 side walls 130, 132 are selected so that the inner wall of the top surface segment 56 does not push against the catheter hub. By positioning the second segment 20 overlying the catheter hub 75, the catheter hub is protected or secured against undesirable movement or at least prevented from excessive movement. In some embodiments, the engagement element 82 can include a simple vertical tab or rib. In another example, the engagement element 82 can include a tab having a specific shape 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 similar to a rib, barb, or hook. When the hook 92 is placed through the slot 55, this allows the engagement member or element 82 to form a more secure mechanical engagement with the slot 55. In this way, the catheter hub 75 is mechanically engaged to the base portion 40 and the fixation is not based solely on adhesive or tape.

In other embodiments, the engagement element 82 may comprise a single "T" shaped element, wherein the crossbar of the "T" shaped element compresses when it enters the slot 55 and then expands once the crossbar exits the slot 55. Still other alternative engagement elements 82 may comprise a rod extending from the catheter hub 75, the rod being topped with a hemispherical structure, similar to the head of a mushroom. The hemispherical structure will radially compress when entering the slot 44 (which may be circular), and then expand back when exiting the slot. Slits or slots may be provided on the hemispherical structure to facilitate flexion. In yet another embodiment, a rotatable latch may be used to secure the catheter hub 75 to the anchor portion 20. In yet another example, the engagement element 82 is sized so that it frictionally engages the slot 55 or is an interference fit within the slot 55.

FIG7 illustrates an alternative embodiment in which an adhesive pad is used to secure the stabilizing elements 42, 44 of the anchor portion 20 to the patient, which can be the same or substantially the same as the anchor portion discussed elsewhere herein. In this embodiment, a "U"-shaped adhesive pad or dressing 146 can be used to attach the stabilizing elements 42, 44 extending from the base portion 40 to the patient 110. The adhesive pad or dressing 146 is "U"-shaped, with the base 180 of the "U" positioned distal to where the catheter hub 76 enters the patient 110. The two sides 182, 184 of the "U" 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 can be narrower than the width of the stabilizing elements, can be the same width as the stabilizing elements, or can be wider than the width of the stabilizing elements. The two side portions 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 so that it covers all of the stabilization elements 42, 44. In other embodiments, the dressing may leave some of one or both stabilization elements 42, 44 exposed and uncovered. In still other embodiments, the dressing 146 may be positioned just off the side or proximal edges of the stabilization elements 42, 44. Other embodiments may use dressings of other shapes, including "V" shaped dressings, "D" shaped dressings, or dressings extending from each stabilization element 42 in a variety of shapes, including square, rectangular, triangular, and semicircular.

In some embodiments, the dressing 146 is integrally formed with the base portion 40 of the second segment or anchor 20, and the stabilizing elements 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 inserting the catheter, the user separates the two segments 10, 20 of the protective cap 5 and then places the base portion 40 of the second segment 20 onto the catheter hub 75. The user removes the release liner 78 from the dressing 146 and applies it to the patient's skin. The dressing may be made of a soft material to provide additional stabilization by firmly adhering to the patient's skin while providing a larger surface area of contact with the catheter. In one example, the sides 182, 184 of the dressing 146 are unfolded from the sides of the base portion 40, the release liner removed from each side, and then securely applied to the patient's skin.

FIG8 shows an exemplary embodiment of a second segment, fixture, or anchor 20 separated from a first segment 10, wherein stabilizing elements 42, 44 (e.g., wings) are folded over the base portion 40 of the second segment 20. The stabilizing elements 42, 44 can be folded as shown to facilitate packaging of the cap 5 having the anchor 20 of FIG8 , mounted over a needle device or catheter assembly. The folded configuration of the wings provides a relatively smaller width profile and, therefore, a relatively smaller footprint for the needle device. The stabilizing elements 42, 44 are each shown with an adhesive pad 46 and a release liner 78. The stabilizing elements 42, 44 can be flexible and maintained in the folded configuration shown without any restraint or retention measures. In other examples, a repositionable adhesive or other removable adhesive can be used to retain the distal end of each wing in the folded state.

9A shows a protective cap 5 having a first section 10 and a second section 20, which is similar to other protective caps discussed elsewhere herein. In this embodiment, the first and second sections 10, 20 can be mechanically fixed to each other along the detachment line 30 or near the detachment line 30 using a binding device. The binding device for binding the first section 10 to the second section 20 can be included in the interior of the cap 5 so that a smooth outer profile is provided on the outside for aesthetic purposes. In the example, the size and shape of the binding device are configured to provide a smooth outer transition at two outer binding surfaces 220a, 220b at or near the detachment line 30. Markings or traces 232 can be provided on the outside of the base section 40 to help align the components of the binding device, as further discussed below.

FIG9B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction of the cap shown in FIG9A . In an example, two engagement devices 222 (only one shown) may be provided within the interior of the cap 5. For example, one engagement device 222 may be provided on each longitudinal half of the cap, such as along a section of one of the inner sidewall 224 of the base portion 40 and the inner sidewall 226 of the proximal body portion 16 of the first section 10. Each engagement device 222 may include one or more protrusions 228 for engaging corresponding receptacles 230, similar to a hole and pin or snap-fit configuration. In the illustrated embodiment, two protrusions 228 are provided with the base portion 40 for each engagement device 222, projecting into two receptacles 230 provided with the proximal body portion 16. However, the positions of the protrusions and receptacles may be reversed, i.e., with the protrusions being provided with the proximal body portion 16. The engagement between each pair of protrusions 228 and receptacles 230 may be a tight fit, a friction fit, or an interference fit. In an example, the two protrusions 228 may be formed directly with the inner sidewall 224 of the second segment 20 , and the receptacle 230 may be provided on a lug or extension 234 extending from the end of the first segment 10 .

To separate the first section 10 from the second section 20, the user simply spreads the two side walls 130, 132 away from each other or presses the two side walls 130, 132 together, depending on whether the tab 228 is with the base portion 40 or the proximal body portion 16. This will cause the tab 228 to separate from the receptacle 230, allowing the first and second sections 10, 20 to separate from each other at the rip line 30. Once separated, the second section 20 can 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 .

Figure 9D shows the second section 20 of the cap 5 of Figure 9A separated from the first section 10. In an example, the protrusion 228 is embodied as a short stake or post. In other examples, the protrusion 228 is embodied as a dome-shaped section or a partial sphere, as shown in Figure 9D.

FIG10A 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 can be mechanically secured to each other along or near the detachment line 30 using a bonding device 222. As shown, the detachment line of this embodiment may not be straight, for example, it may be curved or wavy. The bonding device 222 for bonding the first section 10 to the second section 20 may be included within the wall surface of the cap 5 and meshed so that a smooth profile is provided on the exterior for aesthetic reasons.

In an example, the coupling device 222 may include a plurality of interlocking tabs 240 that engage a plurality of corresponding receptacles 246, similar to the interlocking tabs on a jigsaw puzzle. In the example shown, there are four tabs 240 to engage four corresponding receptacles 246. In other examples, there may be fewer than four tabs 240, such as three or two tabs, or there may be more than four tabs, such as five or six or more tabs, 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.

FIG10B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction shown in FIG10A. In an example, a coupling device 222 comprising a plurality of interlocking tabs and receptacles may be formed (e.g., molded) directly at the proximal end of the proximal body portion 16 and the distal end of the base member 40. The tabs and receptacles may be snapped together to mate as shown in FIG10A and FIG10B.

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

To separate the first section 10 from the second section 20, the user simply spreads the two sidewalls 130, 132 of the base member 40 away from each other and lifts 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 section 10 and the second section 20 along the separation line 30. This will cause the tabs 240 to separate from the receptacles 240 to allow the first and second sections 10, 20 to separate from each other at the detachment line 30. Once separated, the second portion 20 can be used to secure the catheter hub, as discussed elsewhere herein. In other examples, the first and second sections 10, 20 can be simply pulled in opposite directions to separate the first and second sections 10, 20 along the detachment 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 needle devices and caps, and components thereof, 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 variations will be apparent to those skilled in the art. Furthermore, although the cap is described in connection with the catheter assembly, the same cap can be used on other needle devices, such as hypodermic needles, Seldinger needles, and epidural needles, to name a few. Therefore, it is to be understood that the protective cap and catheter assembly and their components constructed according to the principles of the disclosed apparatus, systems, and methods may be embodied differently than specifically described herein. The present disclosure is further defined in the appended claims.

Technical Field

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

Background Art

Catheters are often used for various infusion therapies, including infusing fluids into a patient, withdrawing blood from a patient, or measuring various parameters of a patient's vascular system. The catheter is typically connected to a catheter connector that is suitable for attaching IV tubing to the catheter. The needle used with the catheter tubing has a sharp tip that is typically covered by a cap during packaging of the catheter assembly. The sharp tip of such a needle poses a safety risk that is often overcome by including a removable cap covering the needle tip and at least a portion of the assembly in a thermoplastic sheath or vacuum bag. After removing the packaging material, the cap is often removed and discarded. After the catheter tubing is placed in the patient's blood vessel and before or after the catheter hub is connected to the IV fluid source, the hub is secured to protect the entry site from inadvertent movement, for example by affixing the catheter hub to the patient's skin.

Summary of the 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 cover the needle shaft, the protective cap comprising a first section and a second section; the first section having a hole for positioning the needle shaft therein, and the second section comprising 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 capable of breaking 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, wherein the protective cap can be separated along a tear line into at least two distinct segments, namely a first segment and a second segment, and wherein one of the two segments can be reused as a securing device.

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

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

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

When the 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 remain folded without the aid of an adhesive.

The 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 cross and each arm may include a distal wall.

The second section of the cap may have two side walls and 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 elongated tubular body or cylindrical portion and an expanded or enlarged proximal body portion. The elongated tubular body and the enlarged proximal body portion may have a hole for accommodating a needle.

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

The needle assembly may include a wing having an adjustable portion, such as a portion that can be trimmed or removed to change the shape of the wing.

The needle assembly may include means for attaching the first segment to the second segment at the line of detachment. The means may include a perforation, a weakened portion, or one or more mechanical interengagements. The line of detachment may be straight, curved, or wavy. The mechanical interengagements, which may also be referred to as coupling means, may include a protrusion and receptacle combination or a lug and receptacle combination, similar to the interlocking lugs on a jigsaw puzzle. The protrusions may be posts, rounded segments, or hemispherical segments.

In some examples, the receptacle can be formed on a tab, and the tab can extend beyond the proximal end of the first segment or can extend beyond the distal end of the second segment.

A glider may be used to help guide the lug into engagement with the receptacle. The glider may be formed using a first section. The second section may slide over the glider when the lug of the coupling device is brought into engagement with the receptacle.

In some examples, when the first section is separated from the second section, the rip line may have a remnant of a torn or broken surface. In other examples, the rip line may have a clean edge, such as an edge formed by molding. For example, when the bonding device is separated to separate the first section from the second section, the edges on the first and second sections may be clean and may have no trace or remnant of a torn or broken surface.

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 welded or by gluing.

In some examples, the proximal end of the first segment may have tabs extending proximally from the proximal end of the first segment when the first segment is separated from the second segment. In other examples, the proximal end of the first segment may have tabs each with at least one receptacle extending proximally from the proximal end of the first segment.

Aspects of the present disclosure also relate to a needle assembly comprising: a catheter hub; a catheter tube extending from a distal end of the catheter hub; a needle at least partially disposed in the catheter tube body; a needle hub attached to the needle; a needle cap positioned to cover the needle and the catheter tube body; the needle cap comprising a first section and a second section, the first section comprising an elongated sleeve having a hole, and the second section comprising a base portion comprising an upper opening and a lower opening and covering at least a portion of the 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 the first section is separated from the second section along a detachment line.

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

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

The needle assembly may further include a tab on the proximal end of the second segment, the tab being sized and shaped to facilitate removal of the second segment 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.

The needle assembly comprises a joining device which joins the first section to the second section at a line of severance.

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

Needle assembly wherein the rip line may be narrow or wavy.

Needle assembly wherein the engagement device may be guided by one or more sliders.

The needle assembly may include a receptacle that is positionable on a tab extending at the proximal end of the first section.

Yet another feature of the present disclosure is a method of stabilizing a puncture site, the method comprising: separating a first section of a protective cap from a second section along a tear line; the first section comprising an elongated sleeve having a hole, and the second section having a base portion comprising two side walls and including a top wall; placing the second section overlying a catheter hub such that the base portion of the second section covers at least a portion of the catheter hub; and securing the base portion using an adhesive to prevent inadvertent movement.

The method may further include securing two wings using 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 segment.

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

The method, wherein the rip line 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.

Yet another feature of the present disclosure includes 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 including a first section and a second section; the first section having a hole for positioning the needle shaft therein, and the second section including a base covering at least a portion of the needle hub; and a rip line formed between the first section and the second section; and wherein the rip 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 for stabilizing a puncture site. The method may include: separating a protective cap along a tear line into a first section and a second section; the first section including an elongated sleeve having a hole, and the second section including a base portion including two side walls and a top wall; placing the second section overlying a catheter hub such that the base portion of the second section covers at least a portion of the catheter hub; and securing the base portion using an adhesive to prevent inadvertent movement.

BRIEF DESCRIPTION OF THE DRAWINGS

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

FIG1A shows a perspective view of the device with the protective cap still attached;

FIG1B shows a partially exploded perspective view of the apparatus of FIG1A ;

FIG2 shows a top view of the device with the stabilization element;

FIG3 shows a side view of the device of FIG2 ;

FIG4A shows a side view of an embodiment of the device just prior to separation;

FIG4B shows a side view of an embodiment of the device after separation;

FIG5 shows a perspective view of a second section of the device;

FIG6 shows a top view of the second section attached to the catheter hub; and

FIG7 shows a perspective view of an embodiment of a device with a dressing;

FIG8 shows the fixing means which is part of the protective cap after the first section of the cap has been removed;

9A-9D show alternative protective caps from different perspectives and in different cross-sections;

10A-10D illustrate alternative protective caps from different perspectives and in different cross-sections.

DETAILED DESCRIPTION

The specific embodiments described below in connection with the accompanying drawings are intended as descriptions of presently preferred embodiments of needle assemblies provided in accordance with aspects of the devices, systems, and methods of the present invention, and are not intended to represent the only forms in which the devices, systems, and methods of the present invention may be constructed or utilized. This description describes the features and steps for constructing and using embodiments of the devices, systems, and methods of the present invention in connection with the embodiments shown. However, it is to be understood that the same or equivalent functions and structures may be achieved by different embodiments, which are also intended to be included within the spirit and scope of the present disclosure. Like reference numerals are intended to indicate like or similar elements or features as indicated elsewhere herein.

FIG1A shows a perspective view of a needle assembly 500, which includes a needle-covered catheter assembly 120 and a cover or cap 5, which is typically frictionally and/or positively engaged to the catheter assembly and removable from the catheter assembly. The cover or cap 5 can be used to cover a needle 15 having a sharp tip or distal tip 37 and act as a protective cap to shield the needle 15 until use. In an example, the cover 5 may include two or more sections 10, 20 that are joined together, for example, integrally formed or mechanically secured to one another. When placed over the catheter assembly 120 before use (e.g., when the assembly is enclosed in a plastic sheath or vacuum bag), the first section 10 typically covers the needle 15 and catheter tubing 76 of the catheter assembly 120. The needle 15 has a shaft 23, a tip 37, and optionally a contoured portion for interacting with a needle guard, such as a corrugation or ridge 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 can engage or frictionally grip the catheter hub 75 to secure the cap 5 to the catheter assembly 120. In some examples, the second section 20 can grip a flange or lug on the needle hub 35. As discussed further below, the second section 20 can be referred to as an anchor or fixation device, and the first section 10 can be referred to as a protective sleeve. After the cap 5 is removed from the catheter assembly 120, the two sections 10, 20 can be separated or detached from each other at the detachment line 30, which is located between the distal and proximal ends of the cap 5. The detachment line 30 can be a fragile or weakened section and can be configured to tear or separate easily under the action of relatively low force. The tear line 30 can be a perforation, a thin 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 causes it to split into at least two separate sections 10, 20 when a sufficient level of force is applied. The tear line 30 can be linear or straight, curved, zigzag, or a combination thereof. Alternatively, as discussed further below, the at least two separate sections 10, 20 can be removably connected using a snap fit arrangement, an engagement arrangement, a detent arrangement, or a combination thereof, and the tear line 30 between the two sections 10, 20 can be separated by releasing the snap fit, releasing the engagement arrangement, or releasing the detent.

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

The first section 10 of the cap 5 is generally elongated and has an aperture for receiving and covering the needle 15 and catheter tubing 76, thereby protecting the user from accidental needle sticks prior to use and/or protecting the plastic sheath when the needle device 500 is positioned within the packaging. As shown, the first section 10 is generally cylindrical in cross-section, but other shapes, such as conical, oval, composite, irregular, polygonal, etc., are also possible. The distal tip 12 of the first section 10, sometimes also referred to as the end, is shown. The distal tip 12 is configured to cover the tip of the needle and has a flat wall surface with one or more optional openings for venting. The main body 14 of the first section 10 is sized and shaped to cover the length of the needle 15 and catheter tubing 76. The length of the first section 10 can be greater than the length of the needle 15 protruding from the catheter hub 75 to ensure sufficient clearance, space, or clearance from the needle tip 37. Utilizing a relatively long length for the first section 10 allows the cap 5 to be used with various assemblies having different needle lengths. In some examples, the cap 5 is configured to cover or accommodate a needle without a catheter tubing, such as an injection needle or an epidural needle. The exact portion of the needle and catheter tubing length covered by the body portion 14 can vary and 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 that transitions 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, which is attached to the 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 sleeve 17 and a 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 at the distal end 18 of the proximal body portion ( FIG. 2 ). The shoulder 33 rises to a larger cross-sectional dimension, and this larger dimension remains constant toward the proximal end, though varying dimensions are 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, sometimes simply referred to as the "base." The tapered proximal body portion 16 has two sidewalls 22 , 24 that transition from vertical to horizontal at a top 122 , meeting at a seam 124 . The tapered proximal body portion 16 has an opening 26 ( FIG. 1A ) positioned opposite the top 122 . In some examples, the seam 124 is simply a raised section or crest at the top 122. In other examples, the seam is omitted or is not easily noticeable. This configuration of sidewalls 22, 24 with underside opening 26 is configured to accommodate attachment of the cap 5 to the remainder of the catheter assembly and removal of the cap 5 from the remainder of the catheter assembly to disengage it from engagement with the catheter hub 75, the needle hub 35, or both.

When positioned over the catheter assembly 120, the second segment 20 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 segment 20 has additional functions not previously recognized, appreciated, or disclosed in any known prior art. In the present disclosure, the second segment 20, in addition to serving as a cover for the catheter hub and/or needle hub, also serves as a stabilization platform. The second segment 20 includes a base portion 40 sized and shaped to cover the catheter hub 75, a top surface segment or upper panel 56, and an opening 105 ( FIG. 5 ) opposite the top surface segment 56. In other embodiments, the base portion 40 is sufficiently sized to cover all or part of the needle hub 35, the catheter hub 75, or both. After a successful venipuncture and placement of the catheter hub 76 within a blood vessel, the second segment 20 can be separated from the first segment 10 and repositioned over the catheter hub 75 without the first segment 10 to stabilize the puncture site. The second section 20 can be provided with an adhesive, have an adhesive applied to it, or both, to anchor a 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 (e.g., a Seldinger needle), the second section 20 can be placed over the needle hub to stabilize it.

FIG1B shows the cap 5 separated from the catheter assembly 120 of FIG1A , for example, before use. The needle 15, needle hub 35, catheter tubing 76, and catheter hub 75 remain connected for venipuncture. The cap 5 of FIG1A and FIG1B may include wings or stabilizing elements 42, 44 extending laterally of the second section 20, as discussed further below.

Figure 2 shows a top view of the cover 5 of Figures 1A and 1B with wings 42 and 44. A 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 tear line 30 is a perforation formed during the injection molding process to form the cover. It can be made from many known thermoplastics and is typically manufactured using a translucent finish with a transparent cover (although opaque covers are also contemplated). Alternatively, the perforation line can be formed during a post-molding process, for example, using laser technology to weaken a section of the protective cover to facilitate separation. In some examples, the tear line 30 comprises 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, as discussed further below, the first and second sections 10, 20 can be separated along the tear line by removing or releasing a mechanical interengagement. Including the detachment 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, unraveling, removing, or twisting. The detachment process will be discussed in more detail below.

Extending laterally from either side 130, 132 of the base portion 40 are stabilizing elements 42, 44, which may also be referred to as wings. In an example, the stabilizing elements 42, 44 are flat and flexible so that they can be folded around the base section 40 when enclosed in the soft cover and can be unfolded to form anchor points for attaching the second section 20, which is covered by the catheter hub, to the patient using one or more pieces of medical tape, as further discussed with reference to FIG8 . The stabilizing elements 42, 44 can be embodied as wings having any number of features formed thereon, including openings or holes, ridges or protrusions for gripping, and/or design features for aesthetics. As an alternative to, or in addition to, using an external or separate medical tape, each stabilizing element 42, 44 may include an adhesive layer 26 (FIG. 3) with a peelable release layer on the bottom surface 48 (FIG. 3) of each element 42, 44, or may be devoid of any adhesive layer. The pliability of the stabilizing elements 42, 44 allows them to be folded over the base portion 40 so as to be folded about the longitudinal axis of the cap and wrapped around the top surface of the second section 20 during packaging and storage of the catheter assembly, as discussed further below. In other embodiments, the stabilizing elements 42, 44 are relatively stronger, stiffer, or more rigid so that they do not fold over the second section 20 during packaging and storage. Alternatively, the soft cover may be sized and shaped to receive the assembly with the wings in an extended position, as shown. In still other embodiments, the stabilizing elements are omitted and the medical tape is applied directly to the base portion 40 of the second section 20 without any stabilizing elements. In another embodiment, stabilizing element or wing portion 42,44 is made of the soft material without any sticky material. In another embodiment, fixture 20 and wing portion 42,44 are made of the single soft material through being molded together into one piece, for example, made of soft plastic. The fixture 20 and wing portion 42,44 formed into one piece by soft material allow fixture 20 and wing portion 42,44 to bend, flex or otherwise be soft to match to medical device or against patient match. In another embodiment, fixture and wing portion are made of the single hard material (for example hard plastic) through being molded together into one piece. Each wing portion 42,44 can be formed as a single piece structure, and this single piece structure is formed to base portion 40, or each wing portion 42,44 can be formed by two or more parts, and these two or more parts use adhesive, welding or other bonding technology to combine together.

The wings 42, 44 can be formed to have any size and shape that will allow a user to apply or otherwise secure the wings 42, 44 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 edge 62, 64 of each stabilizing element 42, 44. The frangible or adjustable portions 52, 54 allow the wings 42, 44 to be resized (e.g., reduced in size) to match the size of an area on the patient or the patient where a catheter is placed. In still other examples, the wings 42, 44 may include multiple lines of frangible or adjustable threads to allow for various resizing options, depending on which frangible thread is selected 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 on a top surface portion or upper panel 56 of base portion 40 near proximal end 58 of base portion 40. Slot or opening 55 is configured for mechanical engagement between second section 20 and catheter hub 75, as will be discussed in greater detail below.

FIG3 shows a side view of the cover 5 of FIG2 . Shown in this view of the cover 5 is the first sidewall 22 of the proximal body portion 16 of the first section 10. The first sidewall 22 has a wall surface that tapers outward from the longitudinal axis and from the maximum outer dimension of the tubular portion 60. The tapered proximal body portion 16 includes a corresponding second sidewall 24 ( FIG1A ) on the opposite side. The first sidewall 22 of the tapered proximal portion 16 transitions to a top surface 122 ( FIG3 ) that connects to the second sidewall 24. A ridge 62 is provided at the top surface 122, defining the centerline of the top surface extending along the longitudinal axis. An upper panel 56, which can be flat or have a curved portion, is positioned at the proximal end of the second section 20 and forms the top of the base portion 40. A lug 64 is formed on the flat panel 56 at the proximal end 58. In one example, the lug 64 is a vertical wall, although tapered walls are also contemplated. The lugs 64 provide leverage for the user to grasp when removing the cover 5 from the catheter assembly or needle device before use. The lugs 64 also provide the user with additional leverage to detach, advance, release, and/or rotate the proximal body portion 16 of the first section 10 to detach from the catheter assembly, thereby removing the cap from the catheter assembly. Additionally, the lugs 64 provide stability to the stabilizing elements 42, 44 when folded onto the top panel 56 of the base portion 40 of the second section 20 during packaging and storage. In other embodiments, the lugs 64 may be omitted, made taller, shorter, wider, or 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 stabilizing elements 42, 44 ( FIG. 2 ) to the patient. In still other embodiments, a dressing may be used in place of medical tape or in combination with medical tape. The dressing is discussed in more detail below.

FIG4A shows the cap 5 after removal from the needle and needle hub, and FIG4B shows the first section 10 of the cap 5 separated from the second section 20 at a tear-off point or line 30. After a successful venipuncture using the catheter assembly 120 of FIG1A and FIG1B and the needle and needle hub are removed from the catheter tubing and catheter hub, the cap 5 can be used to stabilize the catheter hub 75 on the patient to stabilize and/or secure the catheter hub and the puncture site. As shown in FIG4B , the cap 5 is separated into two sections 10, 20 along the tear-off line 30. The tear-off line 30 is fragile and is configured to be easily torn or separated. The tear-off line 30 can be a perforation, a thin section that is more weakened than the rest of the cover, a groove, or any other structural design that will cause inherent weakness and cause the cap 5 to split or break into at least two separate sections 10, 20 at the tear-off line when a sufficient level of force is applied. Alternatively, the first and second sections 10, 20 can be mechanically secured to each other at the tear line 30 and can be separated from each other by unfastening, releasing, undoing, or otherwise separating the mechanical connection at the tear line 30. Preferably, the tear line 30 is configured so that the level of force that occurs accidentally will not be sufficient to cause the cap to split or separate into the two sections 10, 20. However, the level of force required to separate the cap at the tear line 30 can be adjusted, for example, by increasing the gap or length between the perforations or increasing or decreasing the material thickness of the weakened section without departing from the scope of the present disclosure. To cause the two sections 10, 20 to separate, the user applies force to increase 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 develops to the top of the cap 5. At that point, the user applies force to tear the material along the tear line 30 across the top of the cap 5. Of course, other means of separating the first section from the second section can be used, such as using scissors.

After separation, the first segment 10 can be discarded or reused. If the first segment 10 is detached from the second segment 20, the second segment 20 can be reused as a securing device. In an example, the second segment 20 includes a base portion 40, a sidewall 130, and an opening 105 on a side opposite the top surface 56. The second segment 20 is sized and shaped to couple with the catheter hub 75 ( FIG. 1 ) to secure the catheter hub after a venipuncture. By securing the catheter hub 75, undesirable movement of the puncture site due to movement of the catheter hub can be prevented. Therefore, 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 the cap is removed from the needle. For example, the second segment 20 can be separated from the first segment 10 and retained for reuse, such as by placing the second segment 20 over the catheter hub to stabilize it. If stabilizing elements 42, 44 are included and 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 removing the removable liner 78 from each adhesive pad 46, the soft adhesive pads 46 provided with the wings can be used to secure the wings or stabilizing elements 42, 44 to the patient. In other embodiments, external medical tape is used to secure the stabilizing elements 42, 44 to the patient. In still other examples, both the adhesive pads 46 on the wings 42, 44 and the external medical tape are used to secure the second segment 20 to the patient. A mechanical engagement or connection between the catheter hub 75 and the base portion 40 can also be used to secure the second segment 20 to the patient. For example, tabs or threads on the catheter hub can protrude through slots 55 (FIGS. 2 and 5) on the second segment 20 to mechanically engage the catheter hub and the second segment 20, which can be referred to as anchors or securing means.

FIG5 shows the second segment, anchor, or fixation device 20 after being separated from the first segment 10 and oriented so that the stabilizing 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 FIG5 , which generally corresponds to its normal use position when positioned over a catheter hub 75. FIG6 shows the second segment 20 positioned over a catheter hub 75, for example, after a successful venipuncture and the catheter tubing 76 has been placed in a patient's blood vessel. To ensure that the base portion 40 of the anchor 20 is aligned with the catheter hub 75 and that the two are engaged to provide sufficient stability to the catheter hub, a slot or opening 55 on the top surface section 56 of the base portion 50 just distal to the lug 64 can be positioned around an engagement element 82, which can be a protrusion, lug, rib, or threaded portion formed on the catheter hub 75. In some embodiments, the positions of the slot/opening 55 and the protrusion 82 can be reversed, i.e., the catheter hub includes a notch and the base portion 40 includes a protrusion that is configured to protrude into the notch on the catheter hub. The height of the two side walls 130, 132 can be selected so that at least a portion of the inner wall of the top surface segment 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 side walls 130, 132 are selected so that the inner wall of the top surface segment 56 does not push against the catheter hub. By positioning the second segment 20 overlying the catheter hub 75, the catheter hub is protected or secured against undesirable movement or at least prevented from excessive movement. In some embodiments, the engagement element 82 can include a simple vertical tab or rib. In another example, the engagement element 82 can include a tab having a specific shape 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 similar to a rib, barb, or hook. When the hook 92 is placed through the slot 55, this allows the engagement member or element 82 to form a more secure mechanical engagement with the slot 55. In this way, the catheter hub 75 is mechanically engaged to the base portion 40 and the fixation is not based solely on adhesive or tape.

In other embodiments, the engagement element 82 may comprise a single "T" shaped element, wherein the crossbar of the "T" shaped element compresses when it enters the slot 55 and then expands once the crossbar exits the slot 55. Still other alternative engagement elements 82 may comprise a rod extending from the catheter hub 75, the rod being topped with a hemispherical structure, similar to the head of a mushroom. The hemispherical structure will radially compress when entering the slot 44 (which may be circular), and then expand back when exiting the slot. Slits or slots may be provided on the hemispherical structure to facilitate flexion. In yet another embodiment, a rotatable latch may be used to secure the catheter hub 75 to the anchor portion 20. In yet another example, the engagement element 82 is sized so that it frictionally engages the slot 55 or is an interference fit within the slot 55.

FIG7 illustrates an alternative embodiment in which an adhesive pad is used to secure the stabilizing elements 42, 44 of the anchor portion 20 to the patient, which can be the same or substantially the same as the anchor portion discussed elsewhere herein. In this embodiment, a "U"-shaped adhesive pad or dressing 146 can be used to attach the stabilizing elements 42, 44 extending from the base portion 40 to the patient 110. The adhesive pad or dressing 146 is "U"-shaped, with the base 180 of the "U" positioned distal to where the catheter hub 76 enters the patient 110. The two sides 182, 184 of the "U" 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 can be narrower than the width of the stabilizing elements, can be the same width as the stabilizing elements, or can be wider than the width of the stabilizing elements. The two side portions 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 so that it covers all of the stabilization elements 42, 44. In other embodiments, the dressing may leave some of one or both stabilization elements 42, 44 exposed and uncovered. In still other embodiments, the dressing 146 may be positioned just off the side or proximal edges of the stabilization elements 42, 44. Other embodiments may use dressings of other shapes, including "V" shaped dressings, "D" shaped dressings, or dressings extending from each stabilization element 42 in a variety of shapes, including square, rectangular, triangular, and semicircular.

In some embodiments, the dressing 146 is integrally formed with the base portion 40 of the second segment or anchor 20, and the stabilizing elements 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 inserting the catheter, the user separates the two segments 10, 20 of the protective cap 5 and then places the base portion 40 of the second segment 20 onto the catheter hub 75. The user removes the release liner 78 from the dressing 146 and applies it to the patient's skin. The dressing may be made of a soft material to provide additional stabilization by firmly adhering to the patient's skin while providing a larger surface area of contact with the catheter. In one example, the sides 182, 184 of the dressing 146 are unfolded from the sides of the base portion 40, the release liner removed from each side, and then securely applied to the patient's skin.

FIG8 shows an exemplary embodiment of a second segment, fixture, or anchor 20 separated from a first segment 10, wherein stabilizing elements 42, 44 (e.g., wings) are folded over the base portion 40 of the second segment 20. The stabilizing elements 42, 44 can be folded as shown to facilitate packaging of the cap 5 having the anchor 20 of FIG8 , mounted over a needle device or catheter assembly. The folded configuration of the wings provides a relatively smaller width profile and, therefore, a relatively smaller footprint for the needle device. The stabilizing elements 42, 44 are each shown with an adhesive pad 46 and a release liner 78. The stabilizing elements 42, 44 can be flexible and maintained in the folded configuration shown without any restraint or retention measures. In other examples, a repositionable adhesive or other removable adhesive can be used to retain the distal end of each wing in the folded state.

9A shows a protective cap 5 having a first section 10 and a second section 20, which is similar to other protective caps discussed elsewhere herein. In this embodiment, the first and second sections 10, 20 can be mechanically fixed to each other along the detachment line 30 or near the detachment line 30 using a binding device. The binding device for binding the first section 10 to the second section 20 can be included in the interior of the cap 5 so that a smooth outer profile is provided on the outside for aesthetic purposes. In the example, the size and shape of the binding device are configured to provide a smooth outer transition at two outer binding surfaces 220a, 220b at or near the detachment line 30. Markings or traces 232 can be provided on the outside of the base section 40 to help align the components of the binding device, as further discussed below.

FIG9B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction of the cap shown in FIG9A . In an example, two engagement devices 222 (only one shown) may be provided within the interior of the cap 5. For example, one engagement device 222 may be provided on each longitudinal half of the cap, such as along a section of one of the inner sidewall 224 of the base portion 40 and the inner sidewall 226 of the proximal body portion 16 of the first section 10. Each engagement device 222 may include one or more protrusions 228 for engaging corresponding receptacles 230, similar to a hole and pin or snap-fit configuration. In the illustrated embodiment, two protrusions 228 are provided with the base portion 40 for each engagement device 222, projecting into two receptacles 230 provided with the proximal body portion 16. However, the positions of the protrusions and receptacles may be reversed, i.e., with the protrusions being provided with the proximal body portion 16. The engagement between each pair of protrusions 228 and receptacles 230 may be a tight fit, a friction fit, or an interference fit. In an example, the two protrusions 228 may be formed directly with the inner sidewall 224 of the second segment 20 , and the receptacle 230 may be provided on a lug or extension 234 extending from the end of the first segment 10 .

To separate the first section 10 from the second section 20, the user simply spreads the two side walls 130, 132 away from each other or presses the two side walls 130, 132 together, depending on whether the tab 228 is with the base portion 40 or the proximal body portion 16. This will cause the tab 228 to separate from the receptacle 230, allowing the first and second sections 10, 20 to separate from each other at the rip line 30. Once separated, the second section 20 can 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 .

Figure 9D shows the second section 20 of the cap 5 of Figure 9A separated from the first section 10. In an example, the protrusion 228 is embodied as a short stake or post. In other examples, the protrusion 228 is embodied as a dome-shaped section or a partial sphere, as shown in Figure 9D.

FIG10A 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 can be mechanically secured to each other along or near the detachment line 30 using a bonding device 222. As shown, the detachment line of this embodiment may not be straight, for example, it may be curved or wavy. The bonding device 222 for bonding the first section 10 to the second section 20 may be included within the wall surface of the cap 5 and meshed so that a smooth profile is provided on the exterior for aesthetic reasons.

In an example, the coupling device 222 may include a plurality of interlocking tabs 240 that engage a plurality of corresponding receptacles 246, similar to the interlocking tabs on a jigsaw puzzle. In the example shown, there are four tabs 240 to engage four corresponding receptacles 246. In other examples, there may be fewer than four tabs 240, such as three or two tabs, or there may be more than four tabs, such as five or six or more tabs, 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.

FIG10B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction shown in FIG10A. In an example, a coupling device 222 comprising a plurality of interlocking tabs and receptacles may be formed (e.g., molded) directly at the proximal end of the proximal body portion 16 and the distal end of the base member 40. The tabs and receptacles may be snapped together to mate as shown in FIG10A and FIG10B.

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

To separate the first section 10 from the second section 20, the user simply spreads the two sidewalls 130, 132 of the base member 40 away from each other and lifts 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 section 10 and the second section 20 along the separation line 30. This will cause the tabs 240 to separate from the receptacles 240 to allow the first and second sections 10, 20 to separate from each other at the detachment line 30. Once separated, the second portion 20 can be used to secure the catheter hub, as discussed elsewhere herein. In other examples, the first and second sections 10, 20 can be simply pulled in opposite directions to separate the first and second sections 10, 20 along the detachment 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 needle devices and caps, and components thereof, 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 variations will be apparent to those skilled in the art. Furthermore, although the cap is described in connection with the catheter assembly, the same cap can be used on other needle devices, such as hypodermic needles, Seldinger needles, and epidural needles, to name a few. Therefore, it is to be understood that the protective cap and catheter assembly and their components constructed according to the principles of the disclosed apparatus, systems, and methods may be embodied differently than specifically described herein. The present disclosure is further defined in the appended claims.

Technical Field

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

Background Art

Catheters are often used for various infusion therapies, including infusing fluids into a patient, withdrawing blood from a patient, or measuring various parameters of a patient's vascular system. The catheter is typically connected to a catheter connector that is suitable for attaching IV tubing to the catheter. The needle used with the catheter tubing has a sharp tip that is typically covered by a cap during packaging of the catheter assembly. The sharp tip of such a needle poses a safety risk that is often overcome by including a removable cap covering the needle tip and at least a portion of the assembly in a thermoplastic sheath or vacuum bag. After removing the packaging material, the cap is often removed and discarded. After the catheter tubing is placed in the patient's blood vessel and before or after the catheter hub is connected to the IV fluid source, the hub is secured to protect the entry site from inadvertent movement, for example by affixing the catheter hub to the patient's skin.

Summary of the 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 cover the needle shaft, the protective cap comprising a first section and a second section; the first section having a hole for positioning the needle shaft therein, and the second section comprising 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 capable of breaking 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, wherein the protective cap can be separated along a tear line into at least two distinct segments, namely a first segment and a second segment, and wherein one of the two segments can be reused as a securing device.

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

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

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

When the 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 remain folded without the aid of an adhesive.

The 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 cross and each arm may include a distal wall.

The second section of the cap may have two side walls and 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 elongated tubular body or cylindrical portion and an expanded or enlarged proximal body portion. The elongated tubular body and the enlarged proximal body portion may have a hole for accommodating a needle.

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

The needle assembly may include a wing having an adjustable portion, such as a portion that can be trimmed or removed to change the shape of the wing.

The needle assembly may include means for attaching the first segment to the second segment at the line of detachment. The means may include a perforation, a weakened portion, or one or more mechanical interengagements. The line of detachment may be straight, curved, or wavy. The mechanical interengagements, which may also be referred to as coupling means, may include a protrusion and receptacle combination or a lug and receptacle combination, similar to the interlocking lugs on a jigsaw puzzle. The protrusions may be posts, rounded segments, or hemispherical segments.

In some examples, the receptacle can be formed on a tab, and the tab can extend beyond the proximal end of the first segment or can extend beyond the distal end of the second segment.

A glider may be used to help guide the lug into engagement with the receptacle. The glider may be formed using a first section. The second section may slide over the glider when the lug of the coupling device is brought into engagement with the receptacle.

In some examples, when the first section is separated from the second section, the rip line may have a remnant of a torn or broken surface. In other examples, the rip line may have a clean edge, such as an edge formed by molding. For example, when the bonding device is separated to separate the first section from the second section, the edges on the first and second sections may be clean and may have no trace or remnant of a torn or broken surface.

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 welded or by gluing.

In some examples, the proximal end of the first segment may have tabs extending proximally from the proximal end of the first segment when the first segment is separated from the second segment. In other examples, the proximal end of the first segment may have tabs each with at least one receptacle extending proximally from the proximal end of the first segment.

Aspects of the present disclosure also relate to a needle assembly comprising: a catheter hub; a catheter tube extending from a distal end of the catheter hub; a needle at least partially disposed in the catheter tube body; a needle hub attached to the needle; a needle cap positioned to cover the needle and the catheter tube body; the needle cap comprising a first section and a second section, the first section comprising an elongated sleeve having a hole, and the second section comprising a base portion comprising an upper opening and a lower opening and covering at least a portion of the 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 the first section is separated from the second section along a detachment line.

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

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

The needle assembly may further include a tab on the proximal end of the second segment, the tab being sized and shaped to facilitate removal of the second segment 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.

The needle assembly comprises a joining device which joins the first section to the second section at a line of severance.

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

Needle assembly wherein the rip line may be narrow or wavy.

Needle assembly wherein the engagement device may be guided by one or more sliders.

The needle assembly may include a receptacle that is positionable on a tab extending at the proximal end of the first section.

Yet another feature of the present disclosure is a method of stabilizing a puncture site, the method comprising: separating a first section of a protective cap from a second section along a tear line; the first section comprising an elongated sleeve having a hole, and the second section having a base portion comprising two side walls and including a top wall; placing the second section overlying a catheter hub such that the base portion of the second section covers at least a portion of the catheter hub; and securing the base portion using an adhesive to prevent inadvertent movement.

The method may further include securing two wings using 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 segment.

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

The method, wherein the rip line 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.

Yet another feature of the present disclosure includes 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 including a first section and a second section; the first section having a hole for positioning the needle shaft therein, and the second section including a base covering at least a portion of the needle hub; and a rip line formed between the first section and the second section; and wherein the rip 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 for stabilizing a puncture site. The method may include: separating a protective cap along a tear line into a first section and a second section; the first section including an elongated sleeve having a hole, and the second section including a base portion including two side walls and a top wall; placing the second section overlying a catheter hub such that the base portion of the second section covers at least a portion of the catheter hub; and securing the base portion using an adhesive to prevent inadvertent movement.

BRIEF DESCRIPTION OF THE DRAWINGS

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

FIG1A shows a perspective view of the device with the protective cap still attached;

FIG1B shows a partially exploded perspective view of the apparatus of FIG1A ;

FIG2 shows a top view of the device with the stabilization element;

FIG3 shows a side view of the device of FIG2 ;

FIG4A shows a side view of an embodiment of the device just prior to separation;

FIG4B shows a side view of an embodiment of the device after separation;

FIG5 shows a perspective view of a second section of the device;

FIG6 shows a top view of the second section attached to the catheter hub; and

FIG7 shows a perspective view of an embodiment of a device with a dressing;

FIG8 shows the fixing means which is part of the protective cap after the first section of the cap has been removed;

9A-9D show alternative protective caps from different perspectives and in different cross-sections;

10A-10D illustrate alternative protective caps from different perspectives and in different cross-sections.

DETAILED DESCRIPTION

The specific embodiments described below in connection with the accompanying drawings are intended as descriptions of presently preferred embodiments of needle assemblies provided in accordance with aspects of the devices, systems, and methods of the present invention, and are not intended to represent the only forms in which the devices, systems, and methods of the present invention may be constructed or utilized. This description describes the features and steps for constructing and using embodiments of the devices, systems, and methods of the present invention in connection with the embodiments shown. However, it is to be understood that the same or equivalent functions and structures may be achieved by different embodiments, which are also intended to be included within the spirit and scope of the present disclosure. Like reference numerals are intended to indicate like or similar elements or features as indicated elsewhere herein.

FIG1A shows a perspective view of a needle assembly 500, which includes a needle-covered catheter assembly 120 and a cover or cap 5, which is typically frictionally and/or positively engaged to the catheter assembly and removable from the catheter assembly. The cover or cap 5 can be used to cover a needle 15 having a sharp tip or distal tip 37 and act as a protective cap to shield the needle 15 until use. In an example, the cover 5 may include two or more sections 10, 20 that are joined together, for example, integrally formed or mechanically secured to one another. When placed over the catheter assembly 120 before use (e.g., when the assembly is enclosed in a plastic sheath or vacuum bag), the first section 10 typically covers the needle 15 and catheter tubing 76 of the catheter assembly 120. The needle 15 has a shaft 23, a tip 37, and optionally a contoured portion for interacting with a needle guard, such as a corrugation or ridge 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 can engage or frictionally grip the catheter hub 75 to secure the cap 5 to the catheter assembly 120. In some examples, the second section 20 can grip a flange or lug on the needle hub 35. As discussed further below, the second section 20 can be referred to as an anchor or fixation device, and the first section 10 can be referred to as a protective sleeve. After the cap 5 is removed from the catheter assembly 120, the two sections 10, 20 can be separated or detached from each other at the detachment line 30, which is located between the distal and proximal ends of the cap 5. The detachment line 30 can be a fragile or weakened section and can be configured to tear or separate easily under the action of relatively low force. The tear line 30 can be a perforation, a thin 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 causes it to split into at least two separate sections 10, 20 when a sufficient level of force is applied. The tear line 30 can be linear or straight, curved, zigzag, or a combination thereof. Alternatively, as discussed further below, the at least two separate sections 10, 20 can be removably connected using a snap fit arrangement, an engagement arrangement, a detent arrangement, or a combination thereof, and the tear line 30 between the two sections 10, 20 can be separated by releasing the snap fit, releasing the engagement arrangement, or releasing the detent.

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

The first section 10 of the cap 5 is generally elongated and has an aperture for receiving and covering the needle 15 and catheter tubing 76, thereby protecting the user from accidental needle sticks prior to use and/or protecting the plastic sheath when the needle device 500 is positioned within the packaging. As shown, the first section 10 is generally cylindrical in cross-section, but other shapes, such as conical, oval, composite, irregular, polygonal, etc., are also possible. The distal tip 12 of the first section 10, sometimes also referred to as the end, is shown. The distal tip 12 is configured to cover the tip of the needle and has a flat wall surface with one or more optional openings for venting. The main body 14 of the first section 10 is sized and shaped to cover the length of the needle 15 and catheter tubing 76. The length of the first section 10 can be greater than the length of the needle 15 protruding from the catheter hub 75 to ensure sufficient clearance, space, or clearance from the needle tip 37. Utilizing a relatively long length for the first section 10 allows the cap 5 to be used with various assemblies having different needle lengths. In some examples, the cap 5 is configured to cover or accommodate a needle without a catheter tubing, such as an injection needle or an epidural needle. The exact portion of the needle and catheter tubing length covered by the body portion 14 can vary and 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 that transitions 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, which is attached to the 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 sleeve 17 and a 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 at the distal end 18 of the proximal body portion ( FIG. 2 ). The shoulder 33 rises to a larger cross-sectional dimension, and this larger dimension remains constant toward the proximal end, though varying dimensions are 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, sometimes simply referred to as the "base." The tapered proximal body portion 16 has two sidewalls 22 , 24 that transition from vertical to horizontal at a top 122 , meeting at a seam 124 . The tapered proximal body portion 16 has an opening 26 ( FIG. 1A ) positioned opposite the top 122 . In some examples, the seam 124 is simply a raised section or crest at the top 122. In other examples, the seam is omitted or is not easily noticeable. This configuration of sidewalls 22, 24 with underside opening 26 is configured to accommodate attachment of the cap 5 to the remainder of the catheter assembly and removal of the cap 5 from the remainder of the catheter assembly to disengage it from engagement with the catheter hub 75, the needle hub 35, or both.

When positioned over the catheter assembly 120, the second segment 20 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 segment 20 has additional functions not previously recognized, appreciated, or disclosed in any known prior art. In the present disclosure, the second segment 20, in addition to serving as a cover for the catheter hub and/or needle hub, also serves as a stabilization platform. The second segment 20 includes a base portion 40 sized and shaped to cover the catheter hub 75, a top surface segment or upper panel 56, and an opening 105 ( FIG. 5 ) opposite the top surface segment 56. In other embodiments, the base portion 40 is sufficiently sized to cover all or part of the needle hub 35, the catheter hub 75, or both. After a successful venipuncture and placement of the catheter hub 76 within a blood vessel, the second segment 20 can be separated from the first segment 10 and repositioned over the catheter hub 75 without the first segment 10 to stabilize the puncture site. The second section 20 can be provided with an adhesive, have an adhesive applied to it, or both, to anchor a 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 (e.g., a Seldinger needle), the second section 20 can be placed over the needle hub to stabilize it.

FIG1B shows the cap 5 separated from the catheter assembly 120 of FIG1A , for example, before use. The needle 15, needle hub 35, catheter tubing 76, and catheter hub 75 remain connected for venipuncture. The cap 5 of FIG1A and FIG1B may include wings or stabilizing elements 42, 44 extending laterally of the second section 20, as discussed further below.

Figure 2 shows a top view of the cover 5 of Figures 1A and 1B with wings 42 and 44. A 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 tear line 30 is a perforation formed during the injection molding process to form the cover. It can be made from many known thermoplastics and is typically manufactured using a translucent finish with a transparent cover (although opaque covers are also contemplated). Alternatively, the perforation line can be formed during a post-molding process, for example, using laser technology to weaken a section of the protective cover to facilitate separation. In some examples, the tear line 30 comprises 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, as discussed further below, the first and second sections 10, 20 can be separated along the tear line by removing or releasing a mechanical interengagement. Including the detachment 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, unraveling, removing, or twisting. The detachment process will be discussed in more detail below.

Extending laterally from either side 130, 132 of the base portion 40 are stabilizing elements 42, 44, which may also be referred to as wings. In an example, the stabilizing elements 42, 44 are flat and flexible so that they can be folded around the base section 40 when enclosed in the soft cover and can be unfolded to form anchor points for attaching the second section 20, which is covered by the catheter hub, to the patient using one or more pieces of medical tape, as further discussed with reference to FIG8 . The stabilizing elements 42, 44 can be embodied as wings having any number of features formed thereon, including openings or holes, ridges or protrusions for gripping, and/or design features for aesthetics. As an alternative to, or in addition to, using an external or separate medical tape, each stabilizing element 42, 44 may include an adhesive layer 26 (FIG. 3) with a peelable release layer on the bottom surface 48 (FIG. 3) of each element 42, 44, or may be devoid of any adhesive layer. The pliability of the stabilizing elements 42, 44 allows them to be folded over the base portion 40 so as to be folded about the longitudinal axis of the cap and wrapped around the top surface of the second section 20 during packaging and storage of the catheter assembly, as discussed further below. In other embodiments, the stabilizing elements 42, 44 are relatively stronger, stiffer, or more rigid so that they do not fold over the second section 20 during packaging and storage. Alternatively, the soft cover may be sized and shaped to receive the assembly with the wings in an extended position, as shown. In still other embodiments, the stabilizing elements are omitted and the medical tape is applied directly to the base portion 40 of the second section 20 without any stabilizing elements. In another embodiment, stabilizing element or wing portion 42,44 is made of the soft material without any sticky material. In another embodiment, fixture 20 and wing portion 42,44 are made of the single soft material through being molded together into one piece, for example, made of soft plastic. The fixture 20 and wing portion 42,44 formed into one piece by soft material allow fixture 20 and wing portion 42,44 to bend, flex or otherwise be soft to match to medical device or against patient match. In another embodiment, fixture and wing portion are made of the single hard material (for example hard plastic) through being molded together into one piece. Each wing portion 42,44 can be formed as a single piece structure, and this single piece structure is formed to base portion 40, or each wing portion 42,44 can be formed by two or more parts, and these two or more parts use adhesive, welding or other bonding technology to combine together.

The wings 42, 44 can be formed to have any size and shape that will allow a user to apply or otherwise secure the wings 42, 44 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 edge 62, 64 of each stabilizing element 42, 44. The frangible or adjustable portions 52, 54 allow the wings 42, 44 to be resized (e.g., reduced in size) to match the size of an area on the patient or the patient where a catheter is placed. In still other examples, the wings 42, 44 may include multiple lines of frangible or adjustable threads to allow for various resizing options, depending on which frangible thread is selected 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 on a top surface portion or upper panel 56 of base portion 40 near proximal end 58 of base portion 40. Slot or opening 55 is configured for mechanical engagement between second section 20 and catheter hub 75, as will be discussed in greater detail below.

FIG3 shows a side view of the cover 5 of FIG2 . Shown in this view of the cover 5 is the first sidewall 22 of the proximal body portion 16 of the first section 10. The first sidewall 22 has a wall surface that tapers outward from the longitudinal axis and from the maximum outer dimension of the tubular portion 60. The tapered proximal body portion 16 includes a corresponding second sidewall 24 ( FIG1A ) on the opposite side. The first sidewall 22 of the tapered proximal portion 16 transitions to a top surface 122 ( FIG3 ) that connects to the second sidewall 24. A ridge 62 is provided at the top surface 122, defining the centerline of the top surface extending along the longitudinal axis. An upper panel 56, which can be flat or have a curved portion, is positioned at the proximal end of the second section 20 and forms the top of the base portion 40. A lug 64 is formed on the flat panel 56 at the proximal end 58. In one example, the lug 64 is a vertical wall, although tapered walls are also contemplated. The lugs 64 provide leverage for the user to grasp when removing the cover 5 from the catheter assembly or needle device before use. The lugs 64 also provide the user with additional leverage to detach, advance, release, and/or rotate the proximal body portion 16 of the first section 10 to detach from the catheter assembly, thereby removing the cap from the catheter assembly. Additionally, the lugs 64 provide stability to the stabilizing elements 42, 44 when folded onto the top panel 56 of the base portion 40 of the second section 20 during packaging and storage. In other embodiments, the lugs 64 may be omitted, made taller, shorter, wider, or 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 stabilizing elements 42, 44 ( FIG. 2 ) to the patient. In still other embodiments, a dressing may be used in place of medical tape or in combination with medical tape. The dressing is discussed in more detail below.

FIG4A shows the cap 5 after removal from the needle and needle hub, and FIG4B shows the first section 10 of the cap 5 separated from the second section 20 at a tear-off point or line 30. After a successful venipuncture using the catheter assembly 120 of FIG1A and FIG1B and the needle and needle hub are removed from the catheter tubing and catheter hub, the cap 5 can be used to stabilize the catheter hub 75 on the patient to stabilize and/or secure the catheter hub and the puncture site. As shown in FIG4B , the cap 5 is separated into two sections 10, 20 along the tear-off line 30. The tear-off line 30 is fragile and is configured to be easily torn or separated. The tear-off line 30 can be a perforation, a thin section that is more weakened than the rest of the cover, a groove, or any other structural design that will cause inherent weakness and cause the cap 5 to split or break into at least two separate sections 10, 20 at the tear-off line when a sufficient level of force is applied. Alternatively, the first and second sections 10, 20 can be mechanically secured to each other at the tear line 30 and can be separated from each other by unfastening, releasing, undoing, or otherwise separating the mechanical connection at the tear line 30. Preferably, the tear line 30 is configured so that the level of force that occurs accidentally will not be sufficient to cause the cap to split or separate into the two sections 10, 20. However, the level of force required to separate the cap at the tear line 30 can be adjusted, for example, by increasing the gap or length between the perforations or increasing or decreasing the material thickness of the weakened section without departing from the scope of the present disclosure. To cause the two sections 10, 20 to separate, the user applies force to increase 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 develops to the top of the cap 5. At that point, the user applies force to tear the material along the tear line 30 across the top of the cap 5. Of course, other means of separating the first section from the second section can be used, such as using scissors.

After separation, the first segment 10 can be discarded or reused. If the first segment 10 is detached from the second segment 20, the second segment 20 can be reused as a securing device. In an example, the second segment 20 includes a base portion 40, a sidewall 130, and an opening 105 on a side opposite the top surface 56. The second segment 20 is sized and shaped to couple with the catheter hub 75 ( FIG. 1 ) to secure the catheter hub after a venipuncture. By securing the catheter hub 75, undesirable movement of the puncture site due to movement of the catheter hub can be prevented. Therefore, 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 the cap is removed from the needle. For example, the second segment 20 can be separated from the first segment 10 and retained for reuse, such as by placing the second segment 20 over the catheter hub to stabilize it. If stabilizing elements 42, 44 are included and 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 removing the removable liner 78 from each adhesive pad 46, the soft adhesive pads 46 provided with the wings can be used to secure the wings or stabilizing elements 42, 44 to the patient. In other embodiments, external medical tape is used to secure the stabilizing elements 42, 44 to the patient. In still other examples, both the adhesive pads 46 on the wings 42, 44 and the external medical tape are used to secure the second segment 20 to the patient. A mechanical engagement or connection between the catheter hub 75 and the base portion 40 can also be used to secure the second segment 20 to the patient. For example, tabs or threads on the catheter hub can protrude through slots 55 (FIGS. 2 and 5) on the second segment 20 to mechanically engage the catheter hub and the second segment 20, which can be referred to as anchors or securing means.

FIG5 shows the second segment, anchor, or fixation device 20 after being separated from the first segment 10 and oriented so that the stabilizing 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 FIG5 , which generally corresponds to its normal use position when positioned over a catheter hub 75. FIG6 shows the second segment 20 positioned over a catheter hub 75, for example, after a successful venipuncture and the catheter tubing 76 has been placed in a patient's blood vessel. To ensure that the base portion 40 of the anchor 20 is aligned with the catheter hub 75 and that the two are engaged to provide sufficient stability to the catheter hub, a slot or opening 55 on the top surface section 56 of the base portion 50 just distal to the lug 64 can be positioned around an engagement element 82, which can be a protrusion, lug, rib, or threaded portion formed on the catheter hub 75. In some embodiments, the positions of the slot/opening 55 and the protrusion 82 can be reversed, i.e., the catheter hub includes a notch and the base portion 40 includes a protrusion that is configured to protrude into the notch on the catheter hub. The height of the two side walls 130, 132 can be selected so that at least a portion of the inner wall of the top surface segment 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 side walls 130, 132 are selected so that the inner wall of the top surface segment 56 does not push against the catheter hub. By positioning the second segment 20 overlying the catheter hub 75, the catheter hub is protected or secured against undesirable movement or at least prevented from excessive movement. In some embodiments, the engagement element 82 can include a simple vertical tab or rib. In another example, the engagement element 82 can include a tab having a specific shape 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 similar to a rib, barb, or hook. When the hook 92 is placed through the slot 55, this allows the engagement member or element 82 to form a more secure mechanical engagement with the slot 55. In this way, the catheter hub 75 is mechanically engaged to the base portion 40 and the fixation is not based solely on adhesive or tape.

In other embodiments, the engagement element 82 may comprise a single "T" shaped element, wherein the crossbar of the "T" shaped element compresses when it enters the slot 55 and then expands once the crossbar exits the slot 55. Still other alternative engagement elements 82 may comprise a rod extending from the catheter hub 75, the rod being topped with a hemispherical structure, similar to the head of a mushroom. The hemispherical structure will radially compress when entering the slot 44 (which may be circular), and then expand back when exiting the slot. Slits or slots may be provided on the hemispherical structure to facilitate flexion. In yet another embodiment, a rotatable latch may be used to secure the catheter hub 75 to the anchor portion 20. In yet another example, the engagement element 82 is sized so that it frictionally engages the slot 55 or is an interference fit within the slot 55.

FIG7 illustrates an alternative embodiment in which an adhesive pad is used to secure the stabilizing elements 42, 44 of the anchor portion 20 to the patient, which can be the same or substantially the same as the anchor portion discussed elsewhere herein. In this embodiment, a "U"-shaped adhesive pad or dressing 146 can be used to attach the stabilizing elements 42, 44 extending from the base portion 40 to the patient 110. The adhesive pad or dressing 146 is "U"-shaped, with the base 180 of the "U" positioned distal to where the catheter hub 76 enters the patient 110. The two sides 182, 184 of the "U" 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 can be narrower than the width of the stabilizing elements, can be the same width as the stabilizing elements, or can be wider than the width of the stabilizing elements. The two side portions 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 so that it covers all of the stabilization elements 42, 44. In other embodiments, the dressing may leave some of one or both stabilization elements 42, 44 exposed and uncovered. In still other embodiments, the dressing 146 may be positioned just off the side or proximal edges of the stabilization elements 42, 44. Other embodiments may use dressings of other shapes, including "V" shaped dressings, "D" shaped dressings, or dressings extending from each stabilization element 42 in a variety of shapes, including square, rectangular, triangular, and semicircular.

In some embodiments, the dressing 146 is integrally formed with the base portion 40 of the second segment or anchor 20, and the stabilizing elements 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 inserting the catheter, the user separates the two segments 10, 20 of the protective cap 5 and then places the base portion 40 of the second segment 20 onto the catheter hub 75. The user removes the release liner 78 from the dressing 146 and applies it to the patient's skin. The dressing may be made of a soft material to provide additional stabilization by firmly adhering to the patient's skin while providing a larger surface area of contact with the catheter. In one example, the sides 182, 184 of the dressing 146 are unfolded from the sides of the base portion 40, the release liner removed from each side, and then securely applied to the patient's skin.

FIG8 shows an exemplary embodiment of a second segment, fixture, or anchor 20 separated from a first segment 10, wherein stabilizing elements 42, 44 (e.g., wings) are folded over the base portion 40 of the second segment 20. The stabilizing elements 42, 44 can be folded as shown to facilitate packaging of the cap 5 having the anchor 20 of FIG8 , mounted over a needle device or catheter assembly. The folded configuration of the wings provides a relatively smaller width profile and, therefore, a relatively smaller footprint for the needle device. The stabilizing elements 42, 44 are each shown with an adhesive pad 46 and a release liner 78. The stabilizing elements 42, 44 can be flexible and maintained in the folded configuration shown without any restraint or retention measures. In other examples, a repositionable adhesive or other removable adhesive can be used to retain the distal end of each wing in the folded state.

9A shows a protective cap 5 having a first section 10 and a second section 20, which is similar to other protective caps discussed elsewhere herein. In this embodiment, the first and second sections 10, 20 can be mechanically fixed to each other along the detachment line 30 or near the detachment line 30 using a binding device. The binding device for binding the first section 10 to the second section 20 can be included in the interior of the cap 5 so that a smooth outer profile is provided on the outside for aesthetic purposes. In the example, the size and shape of the binding device are configured to provide a smooth outer transition at two outer binding surfaces 220a, 220b at or near the detachment line 30. Markings or traces 232 can be provided on the outside of the base section 40 to help align the components of the binding device, as further discussed below.

FIG9B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction of the cap shown in FIG9A . In an example, two engagement devices 222 (only one shown) may be provided within the interior of the cap 5. For example, one engagement device 222 may be provided on each longitudinal half of the cap, such as along a section of one of the inner sidewall 224 of the base portion 40 and the inner sidewall 226 of the proximal body portion 16 of the first section 10. Each engagement device 222 may include one or more protrusions 228 for engaging corresponding receptacles 230, similar to a hole and pin or snap-fit configuration. In the illustrated embodiment, two protrusions 228 are provided with the base portion 40 for each engagement device 222, projecting into two receptacles 230 provided with the proximal body portion 16. However, the positions of the protrusions and receptacles may be reversed, i.e., with the protrusions being provided with the proximal body portion 16. The engagement between each pair of protrusions 228 and receptacles 230 may be a tight fit, a friction fit, or an interference fit. In an example, the two protrusions 228 may be formed directly with the inner sidewall 224 of the second segment 20 , and the receptacle 230 may be provided on a lug or extension 234 extending from the end of the first segment 10 .

To separate the first section 10 from the second section 20, the user simply spreads the two side walls 130, 132 away from each other or presses the two side walls 130, 132 together, depending on whether the tab 228 is with the base portion 40 or the proximal body portion 16. This will cause the tab 228 to separate from the receptacle 230, allowing the first and second sections 10, 20 to separate from each other at the rip line 30. Once separated, the second section 20 can 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 .

Figure 9D shows the second section 20 of the cap 5 of Figure 9A separated from the first section 10. In an example, the protrusion 228 is embodied as a short stake or post. In other examples, the protrusion 228 is embodied as a dome-shaped section or a partial sphere, as shown in Figure 9D.

FIG10A 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 can be mechanically secured to each other along or near the detachment line 30 using a bonding device 222. As shown, the detachment line of this embodiment may not be straight, for example, it may be curved or wavy. The bonding device 222 for bonding the first section 10 to the second section 20 may be included within the wall surface of the cap 5 and meshed so that a smooth profile is provided on the exterior for aesthetic reasons.

In an example, the coupling device 222 may include a plurality of interlocking tabs 240 that engage a plurality of corresponding receptacles 246, similar to the interlocking tabs on a jigsaw puzzle. In the example shown, there are four tabs 240 to engage four corresponding receptacles 246. In other examples, there may be fewer than four tabs 240, such as three or two tabs, or there may be more than four tabs, such as five or six or more tabs, 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.

FIG10B shows a cross-sectional side view of the cap 5 taken along the longitudinal direction shown in FIG10A. In an example, a coupling device 222 comprising a plurality of interlocking tabs and receptacles may be formed (e.g., molded) directly at the proximal end of the proximal body portion 16 and the distal end of the base member 40. The tabs and receptacles may be snapped together to mate as shown in FIG10A and FIG10B.

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

To separate the first section 10 from the second section 20, the user simply spreads the two sidewalls 130, 132 of the base member 40 away from each other and lifts 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 section 10 and the second section 20 along the separation line 30. This will cause the tabs 240 to separate from the receptacles 240 to allow the first and second sections 10, 20 to separate from each other at the detachment line 30. Once separated, the second portion 20 can be used to secure the catheter hub, as discussed elsewhere herein. In other examples, the first and second sections 10, 20 can be simply pulled in opposite directions to separate the first and second sections 10, 20 along the detachment 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 needle devices and caps, and components thereof, 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 variations will be apparent to those skilled in the art. Furthermore, although the cap is described in connection with the catheter assembly, the same cap can be used on other needle devices, such as hypodermic needles, Seldinger needles, and epidural needles, to name a few. Therefore, it is to be understood that the protective cap and catheter assembly and their components constructed according to the principles of the disclosed apparatus, systems, and methods may be embodied differently than specifically described herein. The present disclosure is further defined in the appended claims.

Claims (10)

1. A needle assembly (500), comprising:

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

A protective cap (5), positioned to cover the needle bar (23) and removable from the needle assembly, the protective cap (5) comprising a first section (10) and a second section (20); the first section (10) having a hole for positioning the needle bar (23) therein, and the second section (20) comprising a base (40) covering at least a portion of the needle hub (35); and

A disassembly line (30) is positioned between the first segment (10) and the second segment (20); and

The split line (30) is a weakened section or a seam held together by a connecting device (222), and the split 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 includes a catheter hub (75) attached to a catheter body (76), wherein the needle bar (23) protrudes through the catheter body (76).

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

4. The needle assembly (500) as claimed in claim 3, wherein the protrusion (82) protrudes through the opening (55).

5. The needle assembly (500) as claimed in any one of claims 1-4, wherein the stabilizing elements (42, 44) extend from the second segment (20).

6. The needle assembly (500) of claim 5 further includes an adhesive pad (46) attached to each stabilizing element (42, 44).

7. The needle assembly (500) as claimed in claim 2 or 3 further includes a needle guard positioned within the catheter hub (75).

8. The needle assembly (500) according to any one of claims 1-4, 6, wherein the second section (20) includes two sidewalls (130, 132) and a top wall (56) having a tapered distal section.

9. The needle assembly (500) of claim 5 further includes an adhesive pad (146) formed in a U-shape, a portion of which is attached to the stabilizing element (42, 44).

10. The needle assembly (500) as claimed in any one of claims 1-4, 6, and 9, wherein the coupling device (222) includes two or more protrusions (228) engaging two or more receptacles (230), or includes two or more lugs (240) engaging two or more receptacles (246).