Adhesive-coated protective caps for needle devices and related methods

Abstract

A needle assembly (100) includes a catheter hub (102), a catheter (105), a needle hub (104), a needle (106), a needle tip (108) extending out of the catheter (105). A protective cap (200, 300, 400) covers the catheter (105) and the needle tip (108). The protective cap (200, 300, 400) has a housing (210, 310) with a first opening (214) at a proximal end of the housing (219, 319), a proximal lumen (220) having a needle tip (108) and a catheter (105) located in the proximal lumen (220), a second opening (212) at an opposite end of the first opening (214) and opening into a distal lumen (230, 330). A cover (260, 360) is removably attached to the rim (211, 336) at the second opening (212) to seal the solution inside the distal cavity (230, 330). Solution can be dispensed from the distal lumen (230, 330).

Description

Technical Field

[0001] The present disclosure relates generally to needle devices, and more particularly to a protective cap for a needle device and related methods, the protective cap having an adhesive stored in the protective cap for securing a catheter after a successful venipuncture. Background Art

[0002] An intravenous ("IV") catheter assembly or needle set is a common medical invasive device that is routinely used for a variety of infusion therapies, including infusing fluids into a patient, drawing blood from a patient, or monitoring various parameters of a patient's vascular system. An IV catheter assembly is inserted in the majority of all hospitalized patients during their hospital stay and is frequently used in many emergency situations.

[0003] IV catheter assemblies use needles with sharp tips that are typically covered by a cap during the packaging of the catheter assembly. The sharp tips of such needles pose a safety hazard that is often overcome by including a removable protective cap or cover within the thermoplastic wrap or vacuum packaging that covers the needle tip and at least a portion of the assembly. After removal from the packaging material and before the needle and catheter are inserted into a patient, the cap is typically removed and discarded.

[0004] After removing the protective cap, the IV catheter assembly insertion process involves four basic steps: (1) the healthcare provider inserts the needle and catheter together into the patient's vein; (2) with the needle tip inserted into the vein, the healthcare provider pushes on the catheter with his or her fingers, advancing the catheter into the patient's vein; (3) the healthcare provider withdraws the needle by grasping the needle hub end (opposite the needle tip) while using his or her free hand to apply pressure to the patient's skin at the insertion site to slow or stop blood flow through the catheter; and (4) the healthcare provider then tapes the exposed end of the catheter or catheter hub to the patient's skin and connects it to a source of fluid to be infused into the patient's vein.

[0005] Catheters have a very high failure rate, primarily due to inadequate fixation of the catheter to the patient's skin. For example, a catheter can be accidentally pulled out by the patient or medical staff, or simply fall out, potentially causing blood to leak onto the patient's skin, clothing, or bedding. This can cause pain to the patient, infection, and potential health risks to medical staff exposed to blood. Furthermore, inserting a replacement catheter can be uncomfortable or painful. Therefore, a significant reduction in intravenous catheter failure rates is expected to have a beneficial impact on patient comfort and outcomes, as well as hospital processes and costs. Summary of the Invention

[0006] Aspects of the present disclosure include needle assemblies or devices and related methods of forming and using needle assemblies and components thereof.

[0007] An exemplary needle assembly may be a needle set or an IV catheter assembly. The needle assembly may also be an over-the-needle catheter assembly.

[0008] The needle device may have the configuration described in the various embodiments, or may be varied by combining features from the described embodiments.

[0009] In an example, the needle assembly may include a first hub or catheter hub, a catheter extending distally from the catheter hub, and a second hub or needle hub having a needle tip extending out of the catheter, and a protective cap positioned with the catheter hub and covering the catheter and needle tip.

[0010] The protective cap may be securely connected to the needle device by friction engagement and / or positive engagement.

[0011] The catheter may have a lumen or bore for receiving the needle and have a distal opening or distal end opening.

[0012] The needle may have a needle tip and may include a change in profile proximal to the tip for use with a needle guard.

[0013] The needle tip may extend distally of the distal opening of the catheter in a ready to use position, wherein the profile is changed for use with a needle guard located proximal of the distal tube opening.

[0014] The change in profile may be an enlarged section, such as a crimp, a bulge, or an accumulation of material having a different profile than other diameter sections of the needle shaft.

[0015] The change in profile may be used to interact with the opening through the wall of the needle guard during needle retraction.

[0016] A needle guard may be provided in the inner cavity of the first interface for covering the needle tip in a protected position.

[0017] In some examples, the needle guard may include a proximal wall and two arms extending distally from the proximal wall. In a ready-to-use position and a protective position in which the needle guard covers the needle tip, the two arms may intersect with each other as viewed from the side. In some examples, the two arms of the needle guard may extend in a distal direction without intersecting with each other.

[0018] The protective cap may include a shell having a housing, a first opening at a proximal end, a needle lumen having a needle tip and a catheter located therein, a second opening at a distal end leading to an adhesive lumen, and a rim at the second opening.

[0019] A cover may be removably attached to the rim at the second opening to seal the adhesive solution within the adhesive cavity.

[0020] After removal of the cover, the adhesive solution may be able to dispense from the adhesive cavity.

[0021] The binder solution may be in uncured form.

[0022] The needle cavity may be separated from the adhesive cavity by a barrier.

[0023] A nozzle may project radially outward from the adhesive cavity to facilitate application of the adhesive to the patient.

[0024] The cover may be a film comprising a sealing body and a tab protruding from the sealing body. The tab may be sized and shaped to provide a gripping surface for a user to peel the cover off the protective cap before applying the adhesive.

[0025] The tabs may have a rough texture on opposing surfaces of the tabs.

[0026] The cover may include a cap removably attached to the rim at the second opening and a handle extending from an outer surface of the cap.

[0027] The handle may have a concave surface at the end.

[0028] The base may extend from the inner surface of the cover and into the adhesive cavity.

[0029] The base of the cover may be scalloped to enable the adhesive solution to be scooped from the adhesive cavity.

[0030] The adhesive cavity may include a wall structure defining an adhesive retainer attached to the housing.

[0031] Another aspect of the present disclosure may include a protective cap positioned with a needle device. The protective cap may include a shell having a housing, a first opening at a proximal end, a needle lumen having a needle tip and a catheter positioned therein, a second opening at a distal end leading to an adhesive lumen, and a rim at the second opening.

[0032] A cover may be removably attached to the rim at the second opening to seal the adhesive solution within the adhesive cavity.

[0033] After removal of the cover, the adhesive solution may be able to dispense from the adhesive cavity.

[0034] The barrier may separate the needle cavity from the adhesive cavity.

[0035] A nozzle may project radially outward from the adhesive cavity to facilitate application of the adhesive to the patient.

[0036] The cover may be a film including a sealing body and a tab protruding from the sealing body.

[0037] The tabs may be sized and shaped to provide a gripping surface for a user to peel the cover from the protective cap prior to applying the adhesive.

[0038] The tabs may have a rough texture on opposing surfaces of the tabs.

[0039] The cover may include a cap removably attached to the rim at the second opening and a handle extending from an outer surface of the cap.

[0040] The handle may have a concave surface on the end.

[0041] The base may extend from the inner surface of the cover and into the adhesive cavity.

[0042] The base of the cover may be scalloped to enable the adhesive solution to be scooped from the adhesive cavity.

[0043] The adhesive cavity may include a wall structure defining an adhesive retainer attached to the housing.

[0044] The needle device may include a catheter hub, a catheter extending distally from the catheter hub, and a needle hub having a needle with a needle tip extending out of the catheter.

[0045] Another aspect of the present disclosure includes a method of securing a catheter of a needle assembly to a patient. The method may include removing a protective cap from the needle assembly to expose the catheter and the needle tip, inserting the catheter and the needle with the needle tip extending from the catheter into the patient, removing the needle from the patient, removing a cover removably attached to a rim at a second opening to access an adhesive solution sealed within an adhesive cavity, and dispensing the adhesive solution from the adhesive cavity into the catheter and the patient to secure the catheter to the patient.

[0046] The protective cap includes a shell having a housing, a first opening at a proximal end, a needle lumen having a needle tip and a catheter located therein, a second opening at a distal end leading to an adhesive lumen, and a rim at the second opening.

[0047] The adhesive solution can be dispensed from the adhesive chamber by tilting the protective cap so that the adhesive flows out of the adhesive chamber under the effect of gravity.

[0048] The adhesive solution may be removed from the adhesive cavity by scooping out the adhesive solution using a hood.

[0049] Additional aspects of the present invention may include a needle assembly, which may include: a catheter hub, a catheter extending distally from the catheter hub, and a needle hub having a needle, the needle having a needle tip extending out of the distal end of the catheter; a protective cap at least partially positioned on the catheter hub and covering the catheter and the needle tip, the protective cap comprising: a shell having a housing, a first opening at a proximal end, a proximal cavity having the needle tip and the catheter positioned therein, a second opening distal to the first opening and leading to an opening in the distal cavity, and a rim at the second opening; and a cover removably attached at the second opening to seal a solution inside the distal cavity; and wherein the solution is capable of being dispensed from the distal cavity after the cover is separated from the housing.

[0050] The protective cap may be positioned at least partially around or over the catheter hub by having a cutout at the proximal section that may accommodate wings on the catheter hub.

[0051] The storage cavity or holder of the protective cap may be located remotely from the proximal opening, such as spaced apart.The storage cavity or holder may be located at a distal end of the housing of the protective cap.

[0052] The barrier may separate the proximal lumen from the distal lumen.

[0053] A nozzle may be provided at the distal lumen to facilitate application or dispensing of the solution to the patient.

[0054] The cover may be a film comprising a sealing body and a tab protruding from the sealing body; the tab may be sized and shaped to provide a gripping surface for a user to peel the cover from the protective cap prior to applying the solution.

[0055] The tabs may have a rough texture on opposing surfaces of the tabs.

[0056] The cover may include a cap removably attached to the rim at the second opening and a handle extending from an outer surface of the cap.

[0057] The base of the cover may have a scallop shape to enable solution to be scooped out of the distal cavity.

[0058] Yet another aspect of the present invention may include a protective cap positioned with a needle device, the protective cap comprising: a shell having a housing, a first opening at a proximal end, a proximal cavity having a needle and a tip positioned therein, a second opening distal to the first opening and leading to a distal cavity, and a rim at the second opening; a cover removably attached at the second opening to seal a solution within the distal cavity; and wherein the solution is capable of being dispensed from the distal cavity after the cover is separated from the shell.

[0059] Yet another aspect of the present disclosure is a method of manufacturing a needle assembly. The method may include: forming a catheter hub and attaching a catheter having a distal opening to the catheter hub; coupling a needle hub having a needle with a needle tip to the catheter hub so that the needle extends beyond the distal end of the catheter; placing a protective cap at least partially over the catheter hub and covering the catheter and the needle tip, the protective cap comprising: a shell having a housing, a first opening at a proximal end, a proximal cavity having the needle tip and the catheter positioned therein, a second opening distal to the first opening and leading to the distal cavity, and a rim at the second opening; and a cover removably attached to the second opening to seal a solution within the distal cavity; wherein after the cover is separated from the housing, the solution can be dispensed from the distal cavity.

[0060] The method may include incorporating a needle guard that surrounds or around the needle to cover the needle in a use position, such as after removal of the needle following a successful venipuncture.

[0061] The protective caps described herein may be assembled to a needle device or needle assembly by engaging or grasping features on the needle device, such as features on the catheter hub, the needle hub, or both, to secure the protective cap to the needle device.

[0062] The protective cap can prevent accidental contact with the needle tip and can prevent the needle from being dislodged from the catheter hub prior to use, such as to prevent premature detachment. In an example, the protective cap can engage or grip a flange or tab of the needle hub. The protective cap can be provided for the needle device while it is in its product packaging, such as a peelable plastic case or blister pack.

[0063] When the needle device is ready for use, the needle device and protective cap can be removed from the product packaging, and then the protective cap can be removed from the needle device by pulling the protective cap and needle device away from each other until sufficient tension is achieved to overcome the engagement between the protective cap and the needle device. With the protective cap separated from the needle device, the needle tip and catheter can then be exposed and ready for the user to access the patient's vascular system.

[0064] The point at which the needle and catheter are inserted through the patient's skin is called the insertion point. After a successful venipuncture, the needle hub can be retracted proximally away from the catheter needle to remove the needle from the patient, with the catheter remaining implanted in the patient's peripheral vein. Typically, once removed from the needle device, a conventional protective cap is discarded. However, the protective cap described herein can be retained and used after venipuncture.

[0065] The protective cap of the present disclosure can protect a person from unwanted needle sticks and also serve as a storage unit for storing solutions, fluids, or objects. The storage unit can have a cover to seal the solution or object for storage. The cover can be peeled off from the protective cap and can also be twisted to separate from the protective cap.

[0066] The protective cap may include three components, namely, a housing, an adhesive, fluid, or object carried by a storage unit of the protective cap, and a seal or cover for closing an opening of the storage unit (also referred to as a cavity holder or distal cavity). In an example, the housing may have a body that defines an interior space for accommodating the needle and a storage space, unit, or cavity for carrying the fluid.

[0067] The adhesive fluid or solution can be carried in a cavity or retainer of the housing, and a cover or seal can be removably attached to the housing to enclose the adhesive fluid. When the cover or seal is removed, the adhesive liquid can be accessed. In an example, the cover or seal is incorporated into the housing to enclose in a storage space or unit and to retain the adhesive fluid therein. In other examples, the cover or seal can be press-fitted into the housing or pivotally attached to the housing. The terms "storage space," "storage unit," "storage cavity," "distal cavity," "holding space," or "storage retainer" are used interchangeably to refer to a space formed with or attached to a protective cap that can be enclosed by a cover to seal a liquid, solution, or object.

[0068] The protective cap of the present disclosure not only serves as a cover to shield the needle and enclose the catheter prior to use, but the protective cap may also incorporate a receptacle to store a quantity of adhesive solution that can then be used to secure the catheter to the patient. While the adhesive solution or fluid is disclosed as being stored in the storage space or cavity of the housing, it is contemplated that other items besides adhesive may be stored in the storage cavity of the housing, such as tape, string, elastic band, ink, local anesthetic cream, and the like.

[0069] The adhesive stored in the storage cavity of the housing may be a topical skin adhesive or tissue adhesive that polymerizes in a short period of time after exposure to water or a water-containing substance (such as human tissue). The adhesive is configured to secure the catheter to the patient's skin at the insertion point to anchor the catheter and prevent the catheter from being accidentally removed from the patient after a successful venipuncture. The adhesive solution may also be used to secure the catheter interface to the patient. In an example, the topical skin adhesive is Adhesive type.

[0070] The outer shell of the protective cap can be made of plastic. In one example, the outer shell is made of a hard, flexible, transparent plastic such as polystyrene, polyethylene, polypropylene, polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polymethylpentene (TP), acrylic butadiene styrene (ABS), and polycarbonate (PC). If used in a clinical environment, the plastic material should be medical grade.

[0071] The housing may include a shell having a first section and a second section. The first section may alternatively be referred to as a distal section, and the second section may alternatively be referred to as a proximal section located proximal to the distal section. The distal section and the proximal section may be formed individually or separately and subsequently joined together to form the shell of the housing.

[0072] The distal segment can include a generally elongated distal segment body having an aperture for receiving and covering the needle and catheter to protect the user from accidental needle sticks prior to use and during packaging, to prevent contamination of the needle and catheter, and to protect the plastic wrap from being punctured when the needle device is within the packaging. The distal segment body can be sized and shaped to cover at least the length of the exposed portion of the needle and catheter, but can have other lengths to accommodate needles of other sizes or to accommodate a range of needle sizes.

[0073] The cross-section of the body of the distal section may be generally conical, but may embody other shapes such as cylindrical, conical, elliptical, complex, irregular or polygonal. The user may use the distal section body to grasp the protective cap and remove it from the needle device.

[0074] The distal segment body may or can optionally include one or more viewing slots or vents. When more than one viewing slot is incorporated, the slots may be formed around the perimeter of the distal segment body of the housing near the distal end. The one or more viewing slots may allow a user to quickly identify the presence of a needle tip in the needle device. The viewing slots may also facilitate ventilation during assembly of the protective cap to the needle device. There may be four elongated, trapezoidal viewing slots, equally spaced around the distal end of the distal segment body.

[0075] The shape of the viewing slot is not limited to a trapezoidal shape and may be an elliptical, rectangular, polygonal, irregular, or any other shape. Furthermore, the location of the one or more viewing slots is not limited to being near the distal end and may be provided at any location on the first and / or second portions of the housing, including being randomly located on the cap and not equally spaced from one another.

[0076] The length of the distal segment body can be longer than the length of the needle extending from the catheter hub to ensure adequate clearance, spacing or clearance from the needle tip. The length of the distal body portion can allow the protective cap to be used on different assemblies with different needle lengths. In other words, the protective cap can be a standard cap for a range of needle devices with different needle lengths. In some examples, the protective cap is configured to cover or contain a needle, such as an injection needle or an epidural needle, in the absence of a catheter. The solution stored in the protective cap can also be a topical skin adhesive that is used for wound closure applied to the insertion point after the needle is removed from the patient. The exact portion of the length of the needle and catheter that the distal segment body covers can vary and can depend on various design factors.

[0077] In one embodiment, the diameter of the distal segment body of the protective cap is substantially constant along its longitudinal axis. In other embodiments, the diameter of the distal segment body may taper from the distal end of the distal segment body away from or toward the proximal segment. That is, the distal segment body of the housing may transition from a smaller diameter section at the distal end to an increased cross-sectional area at the proximal end of the proximal segment attached to the housing.

[0078] The distal section of the housing may have an elongated distal section body or an elongated sleeve that transitions into a larger proximal section body of the proximal section. The second or proximal section may have a proximal section body that substantially covers the catheter hub and optionally covers a portion of the needle hub. The shape of the proximal section body may closely match the shape of portions of the catheter hub and the needle hub. The proximal section body of the housing may also serve as a grip for the user when removing the protective cap from the needle device.

[0079] The proximal section body can have a proximal opening at the proximal end, and this proximal opening can be open along a single plane. The proximal section can have an enlarged body, and this body can have a larger width, height and / or diameter than the body of the distal section, to accommodate a catheter interface, a needle interface or both. In other examples, the proximal opening is not limited to a single plane. That is, the part of the proximal opening can be at the most proximal end, and can extend through the part of the proximal section body that is not formed with the entire circumference. This irregular opening (rather than a single plane opening) can allow the protective cap to be fitted on an irregularly shaped interface body, such as an interface body with wings.

[0080] The protective cap may have a needle cavity for covering the catheter (if used with a trocar device) and for covering the needle tip of the needle, which extends distally from the proximal opening through the proximal segment body and into the distal segment body to the distal end of the housing, the housing having a web or barrier that forms part of the storage space for the adhesive solution, as discussed further below. The needle cavity may be large enough to cover or at least partially surround the catheter hub, the catheter, the needle tip, and optionally the needle hub. In an example, the proximal segment body surrounds the flange of the needle hub, and a cutout is provided at the proximal segment to accommodate the wing.

[0081] A guide lip having an inclined or tapered surface may be located at the proximal end of the proximal opening. The guide lip may be formed to provide the user with an additional grip for removing or attaching the protective cap from the needle device. When attaching the cap to the needle device, the tapered surface of the guide lip may help guide the cap onto the needle device.

[0082] As previously discussed, the proximal opening may also extend distally a distance along the side of the housing to accommodate features of a needle device. In other words, the cutout may extend a distance from the proximal plane of the proximal opening along the side of the proximal and, if desired, distal section bodies of the housing.

[0083] The proximal opening can extend distally along the bottom sides of the proximal and distal segment bodies to accommodate a pair of wings extending laterally from the catheter hub of the needle device. The extension of the proximal opening along the side of the housing can also support the operation of an engagement feature on the protective cap for engaging a feature of the needle device. In examples, the engagement feature can be a catch, one or more slots, a detent, or a combination of features that is used to locate and retain the feature of the needle device, such that the protective cap can be released from the needle device by applying a force to either the protective cap or the needle device.

[0084] The engagement feature can be a groove located near the proximal end around the inner periphery of the proximal section body to engage a flange on the needle hub. Because the proximal opening can extend partially along the side of the housing, when a tensile force is applied, the proximal end can expand radially outward, thereby moving the groove radially outward until the flange is no longer captured by the groove, allowing the protective cap to be disengaged from the needle device. The location of the engagement feature is not limited to being near the proximal end of the housing and can engage a feature of the catheter hub rather than the needle hub to secure the protective cap to the needle device before use. Other engagement mechanisms for securing the protective cap to the needle device are contemplated.

[0085] Referring again to the distal section of the housing, the distal section body has a distal opening at the distal end of the cap. The distal opening can be distal to the proximal opening of the protective cap. The distal opening can lead to a storage space or cavity. This feature is unique compared to prior art protective caps, which lack distal openings or, if they do include a venting opening, have relatively small dimensions and communicate with the needle lumen, meaning there is no web or barrier separating the distal cavity from the proximal cavity.

[0086] In an example, the storage cavity for storing the adhesive may extend proximally from the distal opening of the housing to a barrier or web formed within the body of the distal section of the housing. In other words, starting from the distal end of the protective cap, the distal cavity for storing the adhesive is connected, and the distal cavity has a cavity bottom defined by the barrier or web.

[0087] Thus, the adhesive cavity can be considered the distal cavity, and the inner cavity or needle cavity for receiving the needle can be considered the proximal cavity. The distal cavity and the proximal cavity can be separated from each other by a barrier or web. In examples, the distal cavity and the web can be sized and shaped to receive and retain the fluid so that the fluid does not leak into the proximal cavity. Thus, the barrier can serve as an end wall between the adhesive cavity and the needle cavity.

[0088] In an alternative embodiment, an adhesive holder or storage holder having a wall structure defining an adhesive cavity can be directly attached to the distal end of the outer shell of a conventional protective cap to form a distal cavity for storage. The adhesive holder or storage holder can have a cup-like shape with side walls and a bottom wall to form a barrier for storage, such as fluid or cream. In an example, the barrier separating the needle cavity from the adhesive cavity can be the bottom wall of the adhesive or storage holder and / or the distal wall of the outer shell. In still other examples, the distal cavity can have a partition wall to define two different distal chambers. The two distal chambers can store two different materials. In an example, one of the two distal chambers can store an adhesive solution, and the other distal chamber can store adhesive remover, alcohol, lotion, etc.

[0089] The distal end at the distal opening can serve as the rim of the adhesive chamber. The adhesive chamber or distal chamber can be sized and shaped to store a certain amount of adhesive solution or other objects, such as topical creams or inks, and is configured to facilitate easy dispensing of the adhesive solution. The adhesive chamber or distal chamber can have a bowl-like or cup-like shape, with a bottom wall substantially parallel to the rim and a frustoconical side wall extending between the rim and the bottom wall. In an example, the bottom wall can be angled relative to the rim. In another example, the transition from the adhesive chamber or side wall of the adhesive chamber to the rim can have a sharp edge, but can be a chamfered edge or a rounded edge. In still other examples, the rim can be angled so that the plane defined by the rim is angled relative to the longitudinal axis of the protective cap.

[0090] The shape of the rim can be generally circular in end view. However, the rim can have other shapes to facilitate pouring, such as oval, polygonal, or irregular shapes. In yet another example, the shape of the rim can include a spout or pouring portion to facilitate pouring the adhesive solution from the cavity along the spout. In another example, more than one spout can extend from the rim of the adhesive cavity.

[0091] The distal end of the housing can be the rim of the adhesive cavity. This distal end can be flat or planar so that a cap or seal can be attached to the distal end or second opening of the protective cap. For example, a cap or seal can be attached to the rim to seal the solution within the adhesive cavity or distal cavity. In another less preferred embodiment, the rim can be non-planar.

[0092] The seal can be attached to the distal end of the housing or the rim of the adhesive chamber by adhesive, interference fit, threaded engagement, ultrasonic welding, or other active engagement methods. The seal can be made of a material similar to the housing, a harder material, or a relatively softer material. In an example, the seal can be made of a multi-layer peelable layer having a metal layer and a polymer layer for bonding to the rim. In another example, the seal can be made of a single layer of plastic material. In other examples, the seal can be made of a material that will not react with the adhesive stored in the adhesive chamber.

[0093] The peelable seal or cover described herein may include a seal and a tab extending from the seal, which may embody the distal end of the protective cap described herein. The tab may extend or fold along the side surface of the shell and may have a variety of shapes, such as circular, square, oval, etc. The seal may be attached to the edge of the adhesive cavity. The seal may be directly attached to the edge and may have an overhang extending above the distal opening to cover the adhesive cavity and seal the adhesive solution inside the adhesive cavity. The cover or seal may be attached to the edge by an adhesive that is different from the adhesive in the adhesive cavity. The seal may be welded or heat-sealed to the edge instead. The surface of the seal may have texture, may have decorative features, and / or may have a mark with information.

[0094] The distal opening of the shell and the edge around the outer periphery of the adhesive chamber can be circular with a flat end. The shape of the edge and the distal opening is not limited and can be any shape, including oval, polygonal and irregular. As shown, the sealing body can also be circular to match the circular shape of the edge. The lug protrudes from the side of the sealing body and provides a grip for the user to remove the seal from the cap. That is, the lug of the sealing body can be configured to allow the user to grasp and pull to separate the seal from the shell, and more particularly, to separate the seal from the edge around the adhesive chamber to approach the adhesive therein. The shape of the lug can be slightly smaller than, equal to or larger than the sealing body.

[0095] The seal and tabs can be made of a thin film material or a multilayer film. In an example, the thin film material can be an elastic plastic film material with a metal film layer. The thickness of the film is not limited and can be any thickness as long as it has sufficient strength to resist tearing to enable the seal to be peeled off the cap. In addition, the thickness of the cover or seal can vary along the seal. In another example, the seal may or may not have a tab attached to the seal so that the seal can be pierced by a tool to access the adhesive solution inside the adhesive cavity. To assist in dispensing the adhesive, the protective cap, adhesive retainer, or distal cavity can be made of an elastic material to allow the wall surrounding the adhesive cavity to be squeezed to force the adhesive through the punctured seal.

[0096] The seal body may have an inner surface for facing the adhesive cavity when attached to the rim and an outer surface opposite the inner surface that is exposed to the environment. The outer and inner surfaces of the seal body may have a rough texture or a smooth texture. The tab may similarly have an inner and outer surface with a smooth texture or a rough texture. In an example, the inner surface may have a smooth texture to resist adhesion of the adhesive to the inner surface, and both the inner and outer surfaces may have a rough texture to provide friction for the user when grasping and holding the tab to prevent the tab from slipping out of the user's fingertips.

[0097] A coating may also be applied to the interior surface to resist adhesion of the adhesive solution to the interior surface. In an example, the coating may be a plastic film applied to the interior surface to resist adhesion and react with the adhesive.

[0098] In use, after the cover or seal is removed or separated from the rim, the protective cap can be tilted to cause the adhesive solution to flow from the adhesive cavity under the action of gravity to be dispensed to a desired location on the patient, such as an insertion point, to secure the catheter to the patient. In some examples, the protective cap is tilted to the side of the cap having a spout or notch.

[0099] The protective cap may include a pouring portion or spout incorporated into the rim or distal end of the housing. That is, the spout may have an extension extending outwardly from the edge of the rim to define a flow channel to help pour adhesive from the adhesive cavity.

[0100] A raised lip may be provided at a rim having a surface defining a boundary of the rim, including a spout. The rim may be circular with a projection extending from a circular portion to form a spout through which adhesive may be poured. More particularly, after the seal attached to the rim is removed from the rim and the protective cap is tilted, the spout may protrude radially outward from the interior of the adhesive cavity under the action of gravity to facilitate the pouring of adhesive from the adhesive cavity. The spout may protrude radially outward to allow adhesive to flow out of the adhesive cavity in a directed manner along the direction of the spout. Compared to a similar cap without a spout, with the spout, less tilting of the protective cap is required before adhesive flows out of the adhesive cavity.

[0101] In one embodiment, the seal can be attached to the edge of adhesive or distal cavity, to cover and keep adhesive in the adhesive cavity. The seal can include a seal body and a protruding tab from the seal body. In the embodiment shown, the seal body can be circular, but its size is large enough to be attached to the edge that comprises the edge portion with spout. Alternatively, the seal body can be shaped as the edge of the matching adhesive cavity, comprises an extension for covering the spout. The seal can be attached to the edge, wherein the tab is away from the spout at the side of the spout, so that the user can provide a grip.

[0102] In an example, the adhesive or storage holder is formed separately and subsequently attached to the distal end of the housing of the protective cap. That is, the housing may include a housing 319 and an adhesive holder that is secured to the distal end of the housing, such as by gluing, bonding, or welding, rather than by a single injection molding. Alternatively, the adhesive holder may be formed integrally or individually with the housing, such as by a single injection molding.

[0103] In a separately formed adhesive holder or storage holder, the storage holder includes a holder body having a rim surrounding a distal opening at a distal end. If the holder body does not have a bottom wall, the adhesive cavity may extend proximally from the distal opening of the adhesive holder to the bottom wall of the adhesive holder or to the distal end of the housing. If the holder body has a bottom wall defining the bottom of the distal cavity, the housing may also have a distal wall at the distal end, or the distal end may not have a distal wall.

[0104] The adhesive retainer or storage retainer may have a multi-point star shape and may include one or more pouring portions or spouts extending radially outward from the retainer body along the entire length of the axial retainer body. Six spouts may be equally spaced around the adhesive retainer to form a six-sided star pattern. When the protective cap is tilted, the spouts allow the adhesive to be guided along the one or more spouts to the insertion point. One or more observation slots or vents may also be provided through the housing to ventilate or provide visual access to the needle end. The side walls of the retainer body may taper inwardly so that the outer dimensions at the edge decrease in a proximal direction toward the bottom of the retainer body.

[0105] The cover for use with the adhesive holder of this embodiment may include: a cover removably attached to the edge of the adhesive holder; and a handle extending from the outer surface of the cover away from the adhesive cavity. The handle may be cylindrical with a concave surface at the end of the cylindrical handle to provide a gripping surface for the user to grasp and remove the cover from the housing. The gripping surface may also have a rough texture to provide a better grip. The handle may be lifted by providing an upper rod between the handle and the cover. The cover can be separated from the edge by pulling, twisting, or shearing the cover from the edge.

[0106] The base can be attached to the lower rod from the inner surface of the cover, and the lower rod extends from the cover to the adhesive cavity. From different angles, the upper rod and the lower rod can be formed as a single rod as a whole, and the cover and the single rod are molded together or integrally molded. The rod can have a surface and can be similar to a cylindrical shaft. When the cover is attached to the edge of the adhesive cavity, the base can contact the bottom of the adhesive cavity or be spaced apart from the bottom of the adhesive cavity. The diameter of the base is greater than the diameter of the lower rod so that the adhesive can be supported on the lower rod and the base to apply the adhesive directly to the insertion point. In addition, when the cover is removed from the housing, the base and the lower rod can be used as a stirring device for mixing the adhesive solution before use and application.

[0107] In another example, a cover for use with a protective cap may include a cover, an upper stem, and a handle. The protective cap may include: a housing having an adhesive cavity at a distal end; and a cover having a cover attached to the distal end of the housing to seal the adhesive within the adhesive cavity. The distal cavity may be formed separately from the housing and may include a web to divide the housing into a distal cavity and a proximal cavity. The handle may extend from the cover away from the adhesive cavity to form a gripping surface for a user to separate the cover from the distal end of the housing, thereby providing access to the adhesive in the adhesive cavity.

[0108] In another example, a cover for use with a protective cap may include a lower stem or base extending into the adhesive cavity, the lower stem or base being scalloped to enable adhesive to be scooped inside the adhesive cavity for application directly to the insertion point using a transfer means. Additionally, upon removal of the cover from the housing, the scalloped lower stem or base may serve as a stirring device for mixing the adhesive prior to use and application.

[0109] Other features and aspects of the disclosure are further described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0110] These and other features and advantages of the present apparatus, systems, and methods will become apparent (as they become better understood) with reference to the specification, claims, and drawings, in which: Figure 1 is a perspective view of an embodiment of a needle assembly having a protective cap removably connected to a needle device; Figure 2 yes Figure 1 A schematic cross-sectional top view of a needle assembly; Figure 3 yes Figure 1 A schematic cross-sectional side view of a needle assembly; Figure 4 yes Figure 1 An enlarged view of the circular portion X in FIG. 1 shows an embodiment of the protective cap; Figure 5 yes Figure 4 A partial schematic cross-sectional view of a protective cap; Figure 6 is a partial perspective view of another embodiment of a protective cap including a seal and a housing having an easy-pour spout; Figure 7 yes Figure 6 A partial perspective view of the protective cap of FIG. 1 , showing the case where the seal is not attached to the housing; Figure 8 yes Figure 1 A partial perspective view of yet another embodiment of a protective cap comprising a seal and an outer cavity attached to a distal end of a housing; Figure 9yes Figure 8 A partial schematic cross-sectional view of a protective cap; Figure 10 yes Figure 8 A partial perspective view of the housing of the protective cap; Figure 11 yes Figure 8 A perspective view of a seal of a protective cap; Figure 12 is a partial perspective view of another embodiment of a needle assembly including a protective cap including a seal attached to a housing; Figure 13 yes Figure 12 A partial schematic cross-sectional view of a needle assembly; Figure 14 is a partial schematic cross-sectional view of another embodiment of a needle assembly including a protective cap including a seal having a scalloped end; and Figure 15 yes Figure 14 A perspective view of the seal. DETAILED DESCRIPTION

[0111] The detailed description set forth below in conjunction with the accompanying drawings is intended to be a description of the currently preferred embodiments of the protective cap for a needle assembly or needle device provided according to aspects of the present device, system, and method, and is not intended to represent the only form in which the present device, system, and method can be constructed or used. The description proposes features and steps for constructing and using the embodiments of the present device, system, and method in conjunction with the illustrated embodiments. However, it is to be understood that the same or equivalent functions and structures can be implemented by different embodiments, which are also intended to be included in the spirit and scope of the present disclosure. As indicated elsewhere herein, similar element numbers are intended to indicate similar or analogous elements or features.

[0112] Figure 1 A perspective view of an IV catheter assembly or needle assembly 100 is shown, which includes a needle guard or protective cap 200 that is removably connected to the catheter hub or needle hub of the catheter assembly. For example, the protective cap 200 can be at least partially positioned on the catheter hub 102 and cover the catheter 105 and the needle tip 108. The IV catheter assembly 100 can alternatively be referred to as an over-the-needle catheter device or IV catheter device or needle device. The needle device 100 can generally have a needle that extends through the catheter, wherein the needle tip extends out of the distal end of the catheter. The catheter can extend distally from the catheter hub, and the needle extends distally from the needle hub. As used herein, the term proximal should be understood to refer to the end or side closer to the practitioner, and the term distal is the opposite end or side. The protective cap 200 can shield the needle tip and cover the catheter before use (such as during packaging and storing the assembly in plastic wrap or vacuum packaging) to avoid accidental puncture or puncture before use.

[0113] Now refer to Figure 2 and Figure 3 , and continue to refer to Figure 1 , protective cap 200 can be securely attached to needle device 100 via frictional engagement and / or positive engagement (such as via a detent). Needle device 100 may include a first hub or catheter hub 102 having an over-the-needle catheter or tubing 105 attached thereto, and a second hub or needle hub 104 having a needle 106 attached thereto. Catheter 105 may have a lumen or bore for receiving the needle and a distal opening or distal end opening. Needle 106 has a needle tip 108 and may include a change in profile 110 located proximal to needle tip 108 for use with a needle guard 120. Needle tip 108 extends distally of the distal end opening of catheter 105 in the ready-to-use position, with profile 110 (if included) being changed for use with needle guard 120 located proximal to the distal tubing opening. The change in profile 110 may be an enlarged section, such as a crimp, a ridge, or a material accumulation having a profile that differs from other diameter sections of the needle shaft.

[0114] As discussed further below, the change in profile 110 can be used to mate with an opening 125 ( 126 ) formed in the wall of the needle guard 120 during retraction of the needle 106. Figure 3 ) interaction. A vent plug 112 is provided at the proximal open end 148 of the second interface 104 and has a vent filter 114 at its proximal end, which is conventional. As shown, the tube 105 is attached to the first interface 102 by a ferrule or metal bushing 116.

[0115] Needle guard 120 is optional and can be positioned within lumen 118 of first interface 102 to cover needle tip 108 in a protected position. When incorporated, needle guard 120 can be one of the needle guards disclosed in U.S. Patent No. 6,616,630, the contents of which are expressly incorporated herein by reference. In some examples, needle guard 120 can be omitted. If so, the change in profile 110 can also be omitted. In still other examples, a needle guard can be included without also including a change in the needle profile. In yet other examples, needle guard 120 can be positioned within the third housing between the first and second interfaces. An exemplary needle guard positioned within the third housing is disclosed in U.S. Patent No. 8,597,249, the contents of which are expressly incorporated herein by reference.

[0116] In an example, the needle guard 120 may include a proximal wall and two arms extending distally of the proximal wall. In the ready-to-use position and the protection position in which the needle guard covers the needle tip, and as viewed from the side, the two arms may intersect each other. In some examples, the two arms of the needle guard 120 may extend in the distal direction without intersecting each other. Two distal walls may be combined, one on each arm, to block the needle tip. The two distal walls may be biased outwardly by the needle 106 in the ready-to-use position and disposed in the profile 122 ( Figure 3 ) distal to the internal changes.

[0117] The internal change in profile 122 can be a section of reduced diameter located immediately adjacent to the larger inner diameter section. Each distal wall on each arm can include a curved lip to eliminate any blunt-angled edges that would contact the side of the needle, facilitating relative movement between the needle guard and the needle during needle retraction. When in the ready-to-use position, at the intersection between each arm and its corresponding distal wall, the dimension measured between the two joints of each arm or elbow is larger than the inner diameter of the internal change in profile 122 of the catheter hub, preventing the needle guard 120 from moving proximally until the radial dimensions of the two elbows of the needle hub 120 decrease. Once the needle tip 108 moves proximally of the two distal walls, the two arms are allowed to move radially inward, and one or both distal walls can close over the needle tip in the protective position to block the needle tip. At that point, the dimension between the two joints decreases and becomes smaller than the inner dimension of the internal change in profile 122, allowing the needle guard 120 to move proximally and be removed from the catheter hub 102 along with the needle 106.

[0118] The first interface 102 has a proximal opening 124 at its proximal end to receive a nose section 126 of the second interface 104 disposed therein. The proximal opening 124 may have a concave luer piece for receiving a male luer tip, such as a syringe, an IV tubing interface, a luer extension, or the like. External threads 130 may be provided on the outer surface of the proximal end of the first interface 102 for threaded engagement with a threaded collar of the male luer tip. Pairs of stabilizing wings 132 may extend radially of the first interface 102 to facilitate securing or anchoring the first interface 102 to the patient after a successful venipuncture. Optionally, wings 132 may be omitted. The first interface 102 may be embodied as a standard IV catheter interface without a tubing port. In other examples, the first interface may include a tubing port. In still other examples, the first interface 102 may include a side fluid port, also known as a port catheter.

[0119] The second interface 104 has a body 140, and the body 140 has an inner cavity 144 ( Figure 3), the inner cavity 144 has the proximal end 142 of the needle 106 extending therein. The inner cavity 144 can serve as a primary blood return chamber. The proximal opening 148 of the body 140 can have a female Luer piece for accommodating the vent plug therein, and the exterior can be threaded or unthreaded. In an example, the exterior of the body 140 of the second interface 104 is generally cylindrical and unthreaded. The first interface and the second interface can be made of a plastic material, such as by plastic injection. The body of the second interface 104 can have some ergonomic grips or bends, such as a flange extending outward from the body 140 near the distal end to serve as a lever during venipuncture.

[0120] The first interface 102 is removably secured to the second interface 104, which has a nose section 126 of the second interface in its proximal opening 124. A flange or extension 134 can be provided on the second interface 104 and, together with the nose section 126, define a gap 136 having a portion of the first interface positioned therein. Alternatively, the flange or extension 134 can be omitted and a stub or other surface-matching feature can be provided to limit the extent to which the second interface 104 can be inserted into the first interface 102. In examples, a rib or annular flange can also extend from the nose section 126 of the second interface 104 to limit the extent to which the nose section 126 can be inserted into the first interface 102.

[0121] The protective cap 200 can be assembled to the needle device by engaging or gripping features on the needle device 100 (such as features on the catheter hub 102, the needle hub 104, or both) to secure the protective cap 200 to the needle device 100. The cap 200 prevents accidental contact with the needle tip and can prevent the needle hub 104 from separating from the catheter hub 102 prior to use, such as to prevent premature separation. In an example, the protective cap 200 can engage or grip the flange 134 or tab of the needle hub 104, the details of which are further discussed below. The protective cap 200 can be provided with the needle device 100 when the needle device is in its product packaging (such as a peelable plastic shell or blister pack).

[0122] When preparing to use needle device 100, can first remove needle device and protective cap from product packaging, then can remove protective cap 200 from needle device 100 by pulling protective cap 200 and needle device 100 away from each other until reaching enough pulling force to overcome the engagement between protective cap 200 and needle device 100. When protective cap 200 is separated from needle device 100, needle end and catheter are now exposed and ready for user to enter patient's vascular system. The point where needle 106 and catheter 105 are inserted through patient's skin is called insertion point. After successful venipuncture, needle hub 104 can be retracted proximally from catheter hub 102 to remove needle 106 from patient, wherein catheter remains implanted in patient's peripheral vein. Typically, once removed from needle device 100, conventional protective cap is discarded. However, as further described below, protective cap 200 described herein can be retained and used after venipuncture.

[0123] In addition, refer to Figure 1-3 The protective cap 200 may include three components: a housing 210, an adhesive or fluid carried by the protective cap, and a seal or cover for enclosing the fluid. In an example, the housing 210 may have a body 219 that defines an interior space for accommodating the needle and a storage space or cavity for carrying the fluid. The adhesive fluid or solution may be carried in a cavity or retainer 230 of the housing 210, and a cover or seal 260 may be removably attached to the housing 210 to enclose the adhesive fluid. When the cover or seal is removed, the adhesive liquid can be accessed. In an example, the cover or seal 260 is coupled to the housing 210 to enclose the storage space and retain the adhesive fluid therein. In other examples, the cover or seal 260 may be press-fitted to the housing 210 or pivotally attached to the housing 210.

[0124] The protective cap 200 of the present disclosure not only serves as a cover to shield the needle 106 and enclose the catheter 105 prior to use, but the protective cap 200 can also incorporate a receptacle to store a quantity of adhesive solution that can then be used to secure the catheter to the patient. While the adhesive solution or fluid is disclosed as being stored in the storage space or cavity 230 of the housing 210, it is contemplated that other items besides adhesive may be stored in the storage cavity 230 of the housing 210, such as tape, string, elastic band, ink, local anesthetic cream, and the like.

[0125] The adhesive stored in the cavity of the housing 210 can be a topical skin adhesive or tissue adhesive that polymerizes in a short period of time after exposure to water or a water-containing substance (such as human tissue). The adhesive is configured to secure the catheter 105 to the patient's skin at the insertion point to anchor the catheter and prevent the catheter from being accidentally removed from the patient after a successful venipuncture. The adhesive solution can also be used to secure the catheter interface to the patient. In an example, the topical skin adhesive is Adhesive type.

[0126] The outer shell 210 of the protective cap 200 can be made of plastic. In one example, the outer shell 210 is made of a hard, flexible, transparent plastic such as polystyrene, polyethylene, polypropylene, polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polymethylpentene (TP), acrylic butadiene styrene (ABS), and polycarbonate (PC). If used in a clinical environment, the plastic material should be medical grade.

[0127] The outer housing 210 includes a housing 219 that may have a first section 205 and a second section 206. The first section 205 may alternatively be referred to as a distal section 205, and the second section 206 may alternatively be referred to as a proximal section 206 located proximal to the distal section 205. The distal section 205 and the proximal section 206 may be formed singly or separately and subsequently joined together to form the housing 219 of the outer shell 210.

[0128] The distal segment 205 may include a generally elongated distal segment body 215 having an aperture for receiving and covering the needle 106 and catheter 105 to protect the user from accidental needle sticks prior to use and during packaging, to prevent contamination of the needle 106 and catheter 105, and to protect the plastic wrap from puncture when the needle device 100 is in the packaging. The distal segment body 215 may be sized and shaped to cover at least the length of the exposed portion of the needle 106 and catheter 105, but may have other lengths to accommodate needles of other sizes or a range of needle sizes. As shown, the distal segment body 215 may have a generally conical cross-section, but may also embody other shapes, such as cylindrical, conical, elliptical, complex, irregular, or polygonal. The user may use the distal segment body 215 to grasp and remove the protective cap 200 from the needle device 100.

[0129] The distal segment body 215 may or can optionally include one or more viewing slots or vents 217. When multiple viewing slots 217 are incorporated, the slots may be formed around the perimeter of the distal segment body 215 of the housing 210 near the distal end 211. The one or more viewing slots 217 may allow a user to quickly identify the presence of the needle tip 108 in the needle device 100. The viewing slots 217 may also facilitate ventilation during assembly of the protective cap 200 to the needle device 100. As shown, there are four elongated, trapezoidal viewing slots 217, equally spaced around the distal end 211 of the distal segment body 215. The shape of the viewing slots 217 is not limited to trapezoidal and may be oval, rectangular, polygonal, irregular, or any other shape. Furthermore, the location of the one or more viewing slots 217 is not limited to near the distal end 211 and may be provided anywhere on the first portion 205 and / or second portion 206 of the housing 210, including randomly located on the cap and unequally spaced from one another.

[0130] The length of the distal segment body 215 can be longer than the length of the needle 106 extending out of the catheter hub 102 to ensure sufficient clearance, spacing or clearance from the needle tip 108. The length of the distal body portion 215 can allow the protective cap 200 to be used on different assemblies with different needle lengths. In other words, the protective cap 200 can be a standard cap for a range of needle devices. In some examples, the protective cap 200 is configured to cover or accommodate a needle, such as an injection needle or an epidural needle, in the absence of a catheter. The adhesive stored in the protective cap 200 can also be a topical skin adhesive that is used for wound closure applied to the insertion point after the needle 106 is removed from the patient. The exact portion of the length of the needle 106 and catheter 105 that the distal segment body 215 covers can vary and can depend on various design factors.

[0131] In one embodiment, the diameter of the distal segment body 215 is substantially constant along its longitudinal axis. In other embodiments, the diameter of the distal segment body 215 can taper from the distal end 211 of the distal segment body 215 away from or toward the proximal segment 216. That is, as discussed further below, the distal segment body 215 of the housing 210 can transition from a smaller diameter section at the distal end 211 to an increased cross-sectional area at the proximal end of the proximal segment 216 attached to the housing 210. As shown, the distal segment 205 of the housing 210 has an elongated distal segment body 215 or elongated sleeve that transitions to a larger proximal segment body 216 of the proximal segment 206. The second or proximal segment 206 has a proximal segment body 216 that substantially covers the catheter hub 102 and optionally covers a portion of the needle hub 104. The shape of the proximal segment body 216 can closely match the shapes of portions of the catheter hub 102 and the needle hub 104. The proximal section body 216 of the housing 210 may also serve as a grip for the user when removing the protective cap 200 from the needle device 100 .

[0132] like Figure 2 As shown in FIG, the proximal section body 216 has a proximal opening 214 at the proximal end 213, which can open along a single plane. The proximal section can have an enlarged body that has a larger width, height, and / or diameter than the body 215 of the distal section to accommodate a catheter hub, a needle hub, or both. In other examples, the proximal opening is not limited to a single plane. That is, as Figure 3 As shown in FIG, a portion of the proximal opening 214 may be proximal-most and may extend through a portion of the proximal segment body 216 that is not formed with a full circumference. This irregular opening (rather than a single planar opening) may allow the protective cap to fit over an irregularly shaped interface body, such as an interface body with wings.

[0133] The protective cap has a needle cavity 220 for covering the catheter 105 and shielding the needle tip 108, which extends distally from the proximal opening 214 through the proximal segment body 216 and into the distal segment body 215 to the distal end of the housing 210, which has a web or barrier 225 that forms part of the storage space for the adhesive solution, as discussed further below. The needle cavity 220 can be large enough to cover or at least partially surround the catheter hub 102, the catheter 105, the needle tip 108, and optionally the needle hub 104. In the example, the proximal segment body 216 surrounds the flange 134 of the needle hub 104, and a cutout is provided at the proximal segment 216 to accommodate the wing 132.

[0134] A guide lip 218 having an inclined or tapered surface is located at the proximal end 213 at the proximal opening 214. The guide lip 218 can be formed to provide an additional grip for the user to remove or attach the protective cap 200 from the needle device 100. When the cap is mounted to the needle device, the tapered surface of the guide lip 218 can help guide the cap onto the needle device.

[0135] As previously discussed, the proximal opening 214 can also extend distally along the side of the housing 210 a distance to accommodate features of the needle device 100. In other words, the cutout can extend a distance from the proximal plane of the proximal opening 214 along the side of the proximal segment body 216 and (if desired) the distal segment body 215 of the housing 210. As shown, the proximal opening 214 extends distally along the bottom side of the proximal segment body 216 and the distal segment body 215 to accommodate the pair of wings 132 extending laterally outward from the catheter hub 102 of the needle device 100. The extension of the proximal opening 214 along the side of the housing 210 can also support the operation of the engagement feature 207 located on the protective cap 200 for engaging features of the needle device 100. In an example, the engagement feature 207 can be a catch, one or more slots, a detent, or a combination of features that is used to locate and retain a feature of the needle device 100 so that the protective cap 200 can be released from the needle device 100 by applying a force to either the protective cap 200 or the needle device 100. As shown, the engagement feature 207 is a slot located near the proximal end 213 around the inner periphery of the proximal segment body 216 to engage the flange 134 on the needle hub 104. Because the proximal opening 214 can extend partially along the side of the housing 100, when a pulling force is applied, the proximal end can expand radially outward, thereby moving the slot radially outward until the flange 134 is no longer captured by the slot, allowing the protective cap 200 to be released from the needle device 100. The location of the engagement feature 207 is not limited to being near the proximal end 213 of the housing 210 and can engage a feature of the catheter hub 102 rather than the needle hub 104 to secure the protective cap 200 to the needle device 100 before use.

[0136] Referring again to the distal section 205 of the housing 210, the distal section body 215 has a distal opening 212 at the distal end 211 of the cap. The distal opening 212 can be distal to the proximal opening of the protective cap. This feature is unique compared to prior art protective caps, which either lack a distal opening or, if they include an opening for venting, have a relatively small size and communicate with the needle lumen 220, meaning there is no web or barrier separating the distal lumen from the proximal lumen. In an example, a cavity 230 for storing adhesive can extend proximally from the distal opening 212 of the housing 210 to a barrier or web 225 formed within the distal section body 215 of the housing 210. In other words, starting from the distal-most end of the protective cap, in conjunction with the distal storage cavity 230, the distal cavity has a cavity bottom defined by the barrier or web 225.

[0137] Thus, the adhesive cavity 230 can be considered to be the distal cavity, and the inner cavity or needle cavity 220 for receiving the needle can be considered to be the proximal cavity. The distal cavity 230 and the proximal cavity 220 are separated from each other by a barrier or web 225. In an example, the distal cavity and the web can be sized and shaped to receive and retain fluid so that the fluid does not leak into the proximal cavity. Thus, the barrier 225 can serve as an end wall of the adhesive cavity 230 and the needle cavity 220. In an alternative embodiment, an adhesive holder or storage holder 235 having a wall structure defining the adhesive cavity 230 can be directly attached to the distal end of the housing of a conventional protective cap to form a distal cavity for storage. The adhesive holder can have a cup-like shape having side walls and a bottom wall to form a barrier for storage, such as fluid or cream. In this example, as will be referenced later Figure 8-11 As discussed, the barrier 225 separating the needle cavity 220 from the adhesive cavity 230 can be the bottom wall of the adhesive or storage holder 235 and / or the distal wall of the housing 210. In yet other examples, the distal cavity 230 can have a dividing wall to define two distinct distal chambers. The two distal chambers can store two different materials. In an example, one of the two distal chambers can store an adhesive solution, and the other distal chamber can store adhesive remover, alcohol, lotion, etc.

[0138] The distal end 211 at the distal opening 212 can serve as the rim of the adhesive chamber 230. The adhesive chamber or distal chamber 230 can be sized and shaped to store a certain amount of adhesive solution or other objects, such as topical creams or inks, and is configured to facilitate easy dispensing of the adhesive solution. As shown, the adhesive chamber or distal chamber 230 has a bowl-like or cup-like shape, wherein a bottom wall 232 is substantially parallel to the rim 211 and a frusto-conical sidewall extends between the rim 211 and the bottom wall 232. In an example, the bottom wall 232 can be angled relative to the rim 211. In another example, the transition from the adhesive chamber 230 or the sidewall of the adhesive chamber 230 to the rim 211 is shown as a sharp edge, but can be a chamfered edge or a rounded edge. In still other examples, the rim 211 can be angled so that the plane defined by the rim is angled relative to the longitudinal axis of the protective cap.

[0139] From an end view, the shape of the edge 211 can be generally circular. However, the edge 211 can have other shapes to facilitate pouring, such as oval, polygonal, or irregular shapes. In yet another example, as described below with reference to Figure 6 and Figure 7 As discussed, the shape of the rim 211 may include a spout or pouring portion 233 for easily pouring the adhesive solution out of the cavity along the spout 233. In another example, as described below with reference to Figure 8-10 As discussed, more than one orifice 233 may extend from the rim 211 of the adhesive cavity 230 .

[0140] The distal end 211 of the housing 210, which is also the rim 211 of the adhesive chamber 230, can be flat or planar so that a cover or seal 260 can be attached to the distal side or second opening of the protective cap. For example, the cover or seal 260 can be attached to the rim 211 to seal the solution inside the adhesive chamber or distal chamber 230. In another less preferred example, the rim 211 can be non-planar. The seal 260 can be attached to the distal end of the housing 210 or the rim 211 of the adhesive chamber 230 by adhesive, interference fit, threaded engagement, ultrasonic welding, or other active engagement methods. The seal 260 can be made of a material similar to the housing 210, a harder material, or a relatively soft material. In an example, the seal 260 can be made of a multi-layer peelable layer having a metal layer and a polymer layer for bonding to the rim. In another example, the seal can be made of a single layer of plastic material. In other examples, seal 260 may be made of a material that will not react with the adhesive stored in adhesive cavity 230 .

[0141] Now refer to Figure 4 and Figure 5 , showing a peelable seal or cover 260, which includes a seal body 265 and a tab 270 extending from the seal body 265a, the tab 270 may be embodied as Figure 1-3 The distal end of the protective cap of any one of the housings 210. The tab 270 can extend or fold along the side surface of the housing 210 and can have a variety of shapes, such as circular, square, oval, etc. The seal 265 is shown attached to the rim 211 of the adhesive cavity 230. The seal 265 is directly attached to the rim 211 and has an overhang that extends over the distal opening 212 to cover the adhesive cavity 230 and seal the adhesive solution inside the adhesive cavity 230. The cover or seal 260 can be attached to the rim 211 with an adhesive that is different from the adhesive in the adhesive cavity. The seal can instead be welded or heat sealed to the rim 211. The surface of the seal 260 can be textured, can have decorative features and / or can have markings with information.

[0142] As shown, the distal opening 212 of the housing 210 and the rim 211 surrounding the outer periphery of the adhesive chamber 230 are circular with flat ends. The shapes of the rim 211 and the distal opening 212 are not limited and can be any shape, including oval, polygonal, and irregular. As shown, the sealing body 265 is also circular to match the circular shape of the rim 211. A tab 270 protrudes from the side of the sealing body 265 and provides a grip for the user to remove the seal from the cap. That is, the tab 270 of the sealing body 265 is configured to allow the user to grasp and pull to separate the seal 260 from the housing, and more particularly, to separate the seal from the rim 211 surrounding the adhesive chamber 230 to access the adhesive therein. The shape of the tab 270 can be slightly smaller than, equal to, or larger than the sealing body 265.

[0143] The seal body 265 and the tab 270 can be made of a thin film material or a multilayer film. In an example, the thin film material can be an elastic plastic film material with a metal film layer. The thickness of the film is not limited and can be any thickness as long as it has sufficient strength to resist tearing to enable the seal to be peeled off the cap. In addition, the thickness of the cover or seal 260 can vary along the seal body 265. In another example, the seal 260 may or may not have a tab 270 attached to the seal body 265, so that the seal body 265 can be pierced by a tool to access the adhesive solution inside the adhesive cavity 230. To assist in dispensing the adhesive, the protective cap 210, the adhesive retainer, or the distal cavity can be made of an elastic material to allow the wall surrounding the adhesive cavity 230 to be compressed to force the adhesive through the punctured seal body 265.

[0144] The seal body 265 may have an inner surface 266 that faces the adhesive cavity 230 when attached to the rim 211, and an outer surface 267 that is opposite the inner surface 266 and is exposed to the environment. The outer surface 267 and the inner surface 266 of the seal body 265 may have a rough texture or a smooth texture. The tab 270 may similarly have an inner surface 271 and an outer surface 272 with a smooth texture or a rough texture. In an example, the inner surface 266 may have a smooth texture to resist adhesion of the adhesive to the inner surface 266, and both the inner surface 271 and the outer surface 272 may have a rough texture to provide friction for the user when grasping and holding the tab 270, thereby preventing the tab 270 from slipping off the user's fingertips. A coating may also be applied to the inner surface 266 to resist adhesion of the adhesive solution to the inner surface. In an example, the coating may be a plastic film applied to the inner surface 266 to resist adhesion and react with the adhesive.

[0145] In use, and after removing the cover or seal 260 from the rim 211, the protective cap 210 can be tilted to allow the adhesive solution to flow from the adhesive cavity 230 under the action of gravity to be dispensed to a desired location on the patient, such as an insertion point, to secure the catheter 105 to the patient. In some examples, the protective cap 210 is tilted to the side of the cap having a spout or notch.

[0146] Figure 6 and Figure 7 Another embodiment of a protective cap 200 is shown. Figure 6 and Figure 7 The protective cap and Figure 4 and Figure 5 The protective cap 200 is similar to and can be used with respect to Figure 4 and Figure 5 The needle device described uses a pouring portion or spout 275, except that it is incorporated into the rim 211 or the distal end of the housing 210. That is, the spout 275 has an extension extending outward from the edge of the rim to define a flow channel to facilitate pouring the adhesive from the adhesive chamber 230. A raised lip can be provided at the rim, which has a surface defining the boundary of the rim, including the spout. As shown, the rim 211 is circular, with a protrusion extending from the circular portion to form the spout 275 through which the adhesive can be poured. More specifically, after the seal 260 attached to the rim is removed from the rim and the protective cap 200 is tilted, the spout 275 can protrude radially outward from the interior of the adhesive chamber 230 under the action of gravity to facilitate pouring the adhesive from the adhesive chamber 230. The spout 275 protrudes radially outward to allow the adhesive to flow out of the adhesive chamber in a directional manner in the direction of the spout 275. With spout 275 , less tilting of protective cap 200 is required before adhesive flows out of adhesive cavity 230 compared to a similar cap without a spout.

[0147] Figure 6 and Figure 7 The cover or seal 260 is also similar to Figure 4 and Figure 5 Seal 260. Seal 260 is attached to rim 211 of adhesive cavity 230 to cover and retain adhesive in adhesive cavity 230. Seal 260 includes a sealing body 265 and a tab 270 protruding from sealing body 265. In the illustrated embodiment, sealing body 265 is circular, but is large enough to attach to rim 211 including a portion of rim 211 with spout 275. Alternatively, sealing body 265 can be shaped to match rim 211 of adhesive cavity 230, including an extension portion for covering spout 275. Figure 7 As shown in FIG, seal 260 may be attached to rim 211 with tabs 270 at the sides of spout 275 away from spout 275 to provide a grip for the user.

[0148] Figure 8-11 Another embodiment of a protective cap 300 is shown. The protective cap 300 includes a housing 310 having a shell 319 and a seal or cover 360. The housing 310 is similar to Figure 4-5 and Figure 6-7 The housing 210 is similar to the housing 210 of FIG. 1 and can be used with a needle device as described, except that the adhesive cavity 330 for storing the adhesive solution is formed in an adhesive or storage holder 335, which is formed separately and then attached to the distal end 311 of the housing 319. That is, the housing 310 includes the housing 319 and the adhesive holder 335 fixed to the distal end 311 of the housing 319. Alternatively, the adhesive holder 335 can be integrally or unitarily formed with the housing 319, such as by injection molding.

[0149] In the illustrated embodiment, the adhesive or storage holder 335 includes a holder body 334 having a rim 336 surrounding a distal opening 332 at a distal end 311. If the holder body 334 does not have a bottom wall, the adhesive cavity 330 may extend proximally from the distal opening 332 of the adhesive holder 335 to the bottom wall of the adhesive holder 335 or to the distal end 311 of the housing 319. If the holder body 334 has a bottom wall defining the bottom of the distal cavity 330, the housing 319 may also have a distal wall at the distal end 311, or the distal end may not have a distal wall. The adhesive or storage holder 335 may have a multi-point star shape and may include one or more pouring portions or spouts 333 extending radially outward from the holder body 334 along the entire length of the axial holder body 334. As shown, six spouts 333 are equally spaced around the adhesive holder 335 to form a six-sided star pattern. As mentioned above Figure 6 and Figure 7 As discussed above with respect to the nozzles 275, the nozzles 333 allow the adhesive to be directed along one or more nozzles 333 to the insertion point when the protective cap is tilted. Figure 4 and Figure 5 One or more viewing slots 317, similar to the one or more viewing slots 217 of the housing 319, may also be provided through the housing 319 for ventilation or to provide visual access to the needle tip 108. The sidewalls of the retainer body 334 may taper inwardly such that the outer dimension at the rim 336 decreases in a proximal direction toward the bottom of the retainer body 334.

[0150] The cover 360 of this embodiment for use with the adhesive holder 335 may include: a cover 364 removably attached to the rim 311 of the adhesive holder 335; and a handle 362 extending from the outer surface of the cover 364 away from the adhesive cavity 330. The handle 362 may be cylindrical with a concave surface at the end of the cylindrical handle to provide a gripping surface for the user to grasp the cover 360 and remove it from the housing 319. The gripping surface may also have a rough texture to provide a better grip. The handle 362 may be lifted by providing an upper rod 363 between the handle 366 and the cover 364. The cover 360 can be separated from the rim 311 by pulling, twisting, or shearing the cover 360 from the rim 311.

[0151] From the inner surface of the cover 364, the base 366 is attached to the lower rod 365 extending from the cover 364 to the adhesive chamber 330. From a different perspective, the upper rod 363 and the lower rod 365 can be formed as a single rod, and the cover 364 can be molded together or integrally molded with the single rod. When the cover 334 is attached to the rim 336 of the adhesive chamber 330, the base 366 can contact the bottom of the adhesive chamber 330 or be spaced apart from the bottom of the adhesive chamber 330. The diameter of the base 366 is greater than the diameter of the lower rod 365, so that the adhesive can be supported on the lower rod 365 and the base 366 to apply the adhesive directly to the insertion point. In addition, when the cover 360 is removed from the housing 310, the base 366 and the lower rod 363 can be used as a stirring device for mixing the adhesive solution before use and application.

[0152] Figure 12 and Figure 13 Another embodiment of a protective cap 400 is shown. The protective cap 400 includes a Figure 4-7 The housing 210 and the housing 210 are similar to Figure 9-11 The cover 360 of the cover 360 does not have the base 366 and the lower rod 365. Figure 4-7 and Figure 9-11 As described, the present protective cap 400 can be used with a needle device.

[0153] The cover 360 may include a cap 364, an upper rod 363, and a handle 362. The protective cap 400 may include: a housing 210 having an adhesive cavity 230 at a distal end 211; and a cover 360 having a cap 364 attached to the distal end 211 of the housing 210, thereby sealing the adhesive within the adhesive cavity 230. The distal cavity 230 may be formed integrally with the housing 210 and may include a web to separate the housing into a distal cavity and a proximal cavity. The handle 362 extends from the cap 364 away from the adhesive cavity 230 to form a gripping surface for a user to separate the cover 360 from the distal end 211 of the housing 210, thereby providing access to the adhesive in the adhesive cavity 230.

[0154] Figure 14 and Figure 15 Another embodiment of a protective cap 400 is shown. The protective cap 400 includes a protective cap similar to Figure 4-7 The housing 210 and the housing 210 are similar to Figure 9-11 The cover 360 of the embodiment of the present invention is scalloped except that the lower stem 365 or base 366 extending into the adhesive cavity 230 is scalloped to enable adhesive to be scooped inside the adhesive cavity 230 so that the adhesive can be applied directly to the insertion point using a transfer means. In addition, when the cover 360 is removed from the housing 210, the scalloped lower stem 365 or base 366 can be used as a stirring device for mixing the adhesive prior to use and application. As shown in FIG. Figure 4-7 and Figure 9-11 As described, the present protective cap 400 can be used with a needle device.

[0155] Needle assemblies or devices including a protective cap having a proximal lumen and a distal lumen, and methods of making and using components thereof are within the scope of the present invention.

[0156] Although limited embodiments of needle devices, protective caps, and their components are specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, various protective caps may be combined with other accessories, etc. In addition, it is understood and contemplated that features specifically discussed for one protective cap embodiment may be used for inclusion in another protective cap embodiment, as long as the functions are compatible. For example, a cover or seal of one protective cap may be used in another embodiment having a different housing. This allows the cover or seal to be interchangeably used with different housings. Therefore, it is understood that needle devices, protective caps, and their components constructed according to the principles of the devices, systems, and methods disclosed herein may be embodied in a manner different from that specifically described herein. The present disclosure is also defined in the following claims.

Claims

1. A needle assembly (100), comprising: a catheter hub (102); a catheter (105) extending distally from the catheter hub (102); and a needle hub (104) having a needle (106) having a needle tip (108) extending beyond the distal end of the catheter; A protective cap (200, 300, 400) is at least partially positioned on the catheter hub (102) and covers the catheter (105) and the needle tip (108), the protective cap (200, 300, 400) comprising: a housing (210, 310) having a shell (219, 319), a first opening (214) at a proximal end, a proximal lumen (220) having the needle tip (108) and the catheter (105) located therein, a second opening (212) distal to the first opening (214) and leading to a distal lumen (230, 330), and a rim (211, 336) at the second opening (212); and a cover (260, 360) removably attached at the second opening (212) to seal the solution inside the distal cavity (230, 330); and wherein after the cover (260, 360) is separated from the housing (219, 319), the solution can be dispensed from the distal cavity (230, 330).

2. The needle assembly (100) according to claim 1, characterized in that A barrier (225) separates the proximal cavity (220) from the distal cavity (230, 330).

3. The needle assembly (100) according to claim 1 or claim 2, characterized in that A nozzle (275, 333) projects radially outwardly from the distal lumen (230, 330) to facilitate application of the solution to the patient.

4. The needle assembly (100) according to any one of the preceding claims, characterized in that The cover (260) is a film comprising a sealing body (265) and a tab (270) protruding from the sealing body (265); the tab (270) is sized and shaped to provide a gripping surface for a user to peel the cover (260) off the protective cap (200) before applying the solution.

5. The needle assembly (100) according to claim 4, characterized in that The tabs (270) have a rough texture on opposing surfaces of the tabs.

6. The needle assembly (100) according to any one of the preceding claims, characterized in that The cover (360) includes a cap (364) removably attached to the rim (336) at the second opening (212) and a handle (362) extending from an outer surface of the cap (364).

7. Needle assembly according to any one of the preceding claims, characterized in that The base of the cover (360) is scalloped to enable the solution to be scooped out of the distal lumen (330).

8. A protective cap (200, 300, 400) positioned with a needle device (100), the protective cap (200, 300, 400) comprising: a housing (210, 310) having a shell (219, 319), a first opening (214) at a proximal end, a proximal cavity (220) having a needle (106) with a tip (108) located therein, a second opening (212) distal to the first opening (214) and leading to a distal cavity (230, 330), and a rim (211, 336) at the second opening (212); a cover (260, 360) removably attached at the second opening (212) to seal the solution inside the distal cavity (230, 330); and wherein after the cover (260, 360) is separated from the housing (219, 319), the solution can be dispensed from the distal cavity (230, 330).

9. The protective cap (200, 300, 400) according to claim 8, characterized in that: A barrier (225) separates the proximal cavity (220) from the distal cavity (230, 330).

10. The protective cap (200, 300, 400) according to claim 8 or claim 9, characterized in that: A nozzle (275, 333) projects radially outwardly from the distal lumen (230, 330) to facilitate application of the solution to the patient.

11. The protective cap (200, 300, 400) according to any one of claims 8 to 10, characterized in that: The cover (260) is a film including a sealing body (265) and a protruding piece (270) protruding from the sealing body (265).

12. The protective cap (200, 300, 400) according to any one of claims 8 to 11, characterized in that: The cover (360) includes a cap (364) removably attached to the rim (336) at the second opening (212) and a handle (362) extending from an outer surface of the cap (364).

13. The protective cap (200, 300, 400) according to any one of claims 8 to 12, characterized in that: The distal cavity (330) includes a wall structure defining a storage retainer (335) attached to the housing (319).

14. A method of manufacturing a needle assembly (100), comprising: forming a catheter hub (102) and attaching a catheter (105) having a distal opening to the catheter hub (102); coupling a needle hub (104) having a needle (106) with a needle tip (108) to the catheter hub (102) such that the needle tip (108) extends beyond the distal end of the catheter (105); A protective cap (200, 300, 400) is at least partially placed on the catheter hub (102) and covers the catheter (105) and the needle tip (108), the protective cap (200, 300, 400) comprising: a housing (210, 310) having a shell (219, 319), a first opening (214) at a proximal end, a proximal lumen (220) having the needle tip (108) and the catheter (105) located therein, a second opening (212) distal to the first opening (214) and leading to a distal lumen (230, 330), and a rim (211, 336) at the second opening (212); and a cover (260, 360) removably attached at the second opening (212) to seal the solution inside the distal cavity (230, 330); and wherein after the cover (260, 360) is separated from the housing (219, 319), the solution can be dispensed from the distal cavity (230, 330).

15. The method according to claim 14, characterized in that The method also includes positioning a needle guard (120) around the needle (106) to cover the needle tip (108) in a use position.

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