Patent Application
20250082907
This disclosure generally relates to medical devices for transacting fluids in a body of a patient, not by way of limitation, to an intravenous access device for administering intravenous fluid.
Intravenous (IV) catheters play a critical role in modern healthcare by enabling healthcare professionals to administer fluids, medications, and other treatments directly into a patient's bloodstream. However, the insertion and management of IV catheters present certain challenges, particularly in terms of preventing accidental needlestick injuries and ensuring patient and healthcare worker safety. Traditional IV catheters lack adequate safety mechanisms to prevent unintentional needlestick injuries, which can lead to the transmission of bloodborne pathogens and other infections.
Incidentally, on an average, the workers suffer from approximately 30 needle stick injuries per 100 hospital beds per year. Most common cases of sharp injuries are unexpected patient reactions, shortage of staff, rushing, distraction, collision with another healthcare worker or passing equipment. These factors can't be controlled accidental needle stick injuries can happen to anyone. These injuries may cause of serious and potential fatal transmission of Hepatitis B or C viruses (HBV, HCV) or HIV. In fact nearly 90,000 healthcare workers worldwide contract Blood-borne injections annually (HBV, HCV, HIV).
Therefore, there is a need for an improved IV catheter with an innovative safety mechanism to address these concerns.
In one embodiment, an intravenous access device for administering intravenous fluids is disclosed. The intravenous access device comprises a tube having a proximal end and a distal end. The distal end includes a beveled tip and is inserted into veins to access veins for administering intravenous fluids. The intravenous access device further comprises a hub attached to the proximal end of the tube. The hub provides gripping support for the intravenous access device when fielded. The intravenous access device further comprises a needle inside the tube and extending through the proximal end and distal end of the tube. The intravenous access device further comprises a clip configured to encapsulate a tip of the needle during removal of the needle. The clip comprises a base having a first set of fins, a plurality of crosspieces connected to the first set of fins. The plurality of crosspieces are operably connected to each other and are arranged in an X-cross section position. Upon exertion of a passive force, the plurality of crosspieces are capable of encapsulating the tip of the needle during removal of the needle. The clip further comprises a second set of fins connected to the first set of fins via the plurality of crosspieces. The second sets of fins are arranged at a top of plurality of the crosspieces. The intravenous access device further comprises a cage configured to encapsulate the clip during removal of the needle. The cage comprises a first aperture, a second aperture formed in a direction opposite to a location of the first aperture and slightly lower to the location of the first aperture, and a plurality of slits formed at a bottom of the cage.
The design of the IV catheter takes patient comfort into consideration. The catheter features a tapered and polished tip that facilitates smooth insertion into the vein, reducing patient discomfort during the process. Additionally, the catheter hub is ergonomically designed, providing a comfortable grip for healthcare professionals during insertion and activation of the safety mechanism.
The IV catheter with safety mechanism is designed to be compatible with standard IV administration sets and equipment, ensuring seamless integration into existing healthcare workflows. Passive force activated safety mechanism is for easy access and intuitive use, enabling healthcare professionals to quickly adopt the new safety technology without extensive training.
The safety mechanism is engineered to function reliably and consistently, minimizing the risk of malfunctions that could compromise patient safety or healthcare worker effectiveness.
The IV catheter design allows for different sizes and configurations to accommodate various patient populations and clinical scenarios. This customization ensures that the safety mechanism remains effective across diverse healthcare contexts.
Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating various embodiments, are intended for purposes of illustration only and are not intended to necessarily limit the scope of the disclosure.
The present disclosure is described in conjunction with the appended figures:
In the appended figures, similar components and/or features may have the same reference label. Further, various components of the same type may be distinguished by following the reference label by a second alphabetical label that distinguishes among the similar components. If only the first reference label is used in the specification, the description is applicable to any one of the similar components having the same first reference label irrespective of the second reference label.
The ensuing description provides preferred exemplary embodiment(s) only, and is not intended to limit the scope, applicability or configuration of the disclosure. Rather, the ensuing description of the preferred exemplary embodiment(s) will provide those skilled in the art with an enabling description for implementing a preferred exemplary embodiment. It is understood that various changes may be made in the function and arrangement of elements without departing from the spirit and scope as set forth in the appended claims.
Embodiments described herein are generally related devices for administering intravenous fluid in the body of a patient. In particular, some embodiments of the disclosure describe processes for removing a needle from the body of the patient without causing pain, discomfort and injury to the patient and a medical operator performing a task of administering intravenous fluids from the body of the patient.
The disclosure specifically indicates that upon retracting of the needle, how a clip encapsulates a tip of the needle and further how clip is encapsulated by a cage of the intravenous access device. This eliminates the risk of accidental needlestick injuries to the patient or a medical operator during the removal of the needle.
Referring to
For administering intravenous fluids, a medical professional operates the intravenous access device 100, where the tube 102 has a proximal end 102a and a distal end 102b. In some embodiments, the intravenous access device 100 may refer to the intravenous (IV) catheter or IV cannula and may be used interchangeably for the clarity of the description of embodiments. The IV cannula is a sterile, non-toxic, and pyrogen-free medical device used to deliver nutritional fluids, saline, medications, or blood products to patient's vascular system. The IV cannula is intended for single-use. The IV cannula is intended to be used for all patients. The needle 106 of IV cannula, which is inserted in the body of the patient during venipuncture may have been exposed to infectious agents. For example, a patient infected with the Acquired Immune Deficiency Syndrome (AIDS) which is frequently or practically fatal in nature, or other dangerous infectious conditions such as Hepatitis B and C virus, there is a constant danger or hazard that the clinical personnel or the para-medical staff may accidentally stick themselves with the used needle after withdrawal from the body of the patient, with the possibility of infection or even death resulting therefrom.
The term “tube” typically refers to the flexible plastic tubing that may be connected to the hub 104 on one end and to a fluid source on the other end. The role of the tube 102 in an IV catheter is to serve as a conduit through which fluids can flow from the source (such as an IV bag or syringe) into the patient's bloodstream. The distal end 102b includes a beveled tip, and the distal end 102b is inserted into veins to access veins for administering the intravenous fluids. Overall, the tube 102 in an IV catheter plays a critical role in delivering fluids, medications, electrolytes, and other therapeutic substances directly into the patient's circulatory system. This method of administration is efficient and rapid, making it suitable for situations where timely and precise delivery of fluids or medications is required. In some embodiments, the tube 102 is made from at least one of a polyvinyl chloride (PVC), polyethylene (PE), polypropylene etc, however the choice of tubing material depends on factors such as the intended use of the tubing, the specific medical application, biocompatibility requirements, regulatory standards to ensure patient safety and device effectiveness, and the types of fluids or medications that will flow through the tube 102.
The hub 104 also known as catheter hub is attached to the proximal end 102a of the tube 102. The hub 104 provides gripping support for the intravenous access device 100, when fielded. The catheter hub 104 is the part of the IV catheter that contains parts inserted into the patient's vein. The catheter hub 104 may include a small plastic hub with a needle or catheter tube extending from it.
In some embodiments, the intravenous access device 100 includes a regulator or a flow control device on the tube 102 that may be adjusted to regulate the rate of fluid infusion. This allows healthcare providers to control the flow rate and ensure that fluids are administered at the appropriate speed. In some embodiments, an external housing 112 of the tube 102 is usually equipped with a mechanism to secure the tube in place, such as a winged grip or adhesive.
The needle 106 is arranged inside the tube 102, and extends through the proximal end 102a and the distal end 102b of the tube 102. The clip 108 is configured to encapsulate a tip of the needle 106 during removal of the needle 106. Additionally the cage 110 is configured to encapsulate the clip 108 during removal of the needle 106.
In some embodiments, the external housing 112 is configured to accommodate the tube 102. In some embodiments, the external housing is made from (PP) Polypropylene Random Copolymer K-RESIN (clear styrene-butadiene block copolymer). The stabilizer 114 is connected to the hub 104 for stabilizing the intravenous access device 100 during insertion and removal.
In some embodiments, the intravenous access device 100 further comprises a cover body configured to cover the hub 104 and a sealing mechanism configured to seal the cover body for intravenous fluids. To prevent fluid leakage from IV catheter tubes, various types of seals and connections are used to ensure a secure and leak-free connection between different components. These seals are crucial to maintaining the integrity of the IV system and preventing any contamination or fluid loss. In some examples, the sealing mechanism may be chosen from at least one of a threaded stopper, luer-lock connector, gasket seals, press-fit seals bayonet locks and adhesive seals.
In some embodiments, the intravenous access device 100 further comprises an indicator to visually indicate proper encapsulation of the clip 108 and the needle 106 inside the cage 110. For example, the indicator may be a transparent window through which healthcare providers can visually confirm that the needle is retracted and locked. This can provide a clear view of the needle's status without the need for direct handling. In another example, a portion of indicator may change color once the needle 106 is safely retracted and locked, providing a visible confirmation. In another example, the indicator may be an audible indicator, such as a click or sound, can provide feedback when the needle is successfully retracted and locked. This auditory cue can be reassuring to healthcare providers. The indicators are designed to give healthcare providers clear and immediate feedback that the needle 106 has been safely retracted and locked after use. The exact design and implementation of the indicators may vary according to application attributes.
The intravenous access device 100 further comprises a release mechanism arranged inside the tube 102 to perform locking of the clip 108 to encapsulate the tip of the needle 106, and encapsulating of the clip 108 by the cage 110 during removal of the needle 106. In some embodiments, the release mechanism comprises two secure-elements, each of the secure elements configured to function on an unlocking angle to perform locking of the clip 108 to encapsulate the tip of the needle 106 upon exertion of a passive force. In an example, each one of the secure elements operate in the range of 287 degrees to 293 degrees. The Teflon holder 120 helps to the joint of the device 100 and the housing 112 and avoids leakage of the blood.
Referring to
The clip 108 has primary functions of needle retraction and locking needle tip. In some embodiments the clip 108 includes an activation system to ensure that the clip 108 is activated by a deliberate action taken by the healthcare provider, such as applying passive force. The clip 108 has structural components to perform needle retraction and locking.
The clip 108 comprises a base 200 having a first set of fins 202a, 202b. A plurality of crosspieces 204a, 204b is connected to the first set of fins 202a, 202b. The plurality of crosspieces 204a, 204b are operably connected to each other and are arranged in an X-cross position. Upon exertion of a passive force, the plurality of crosspieces 204a, 204b are capable of encapsulating the tip of the needle 106 during removal of the needle 106. The clip further comprises a second set 206 of fins connected to the first set of fins 202a, 202b via the plurality of crosspieces 204a, 204b. The second set of fins are arranged at a top of plurality of the crosspieces.
In some embodiments, the base 200 has the first set of fins that is operably connected to the crosspieces via a pivot-joint mechanism. The pivot-joint mechanism may refer to a type of mechanical linkage that enables two components to rotate around a common axis. It allows for relative motion between the two components while maintaining a fixed point of rotation. This type of mechanism is often used in various devices to achieve controlled rotation or angular movement. In such case, the first set of fins and the crosspieces may have a common mechanical linkage that enables the first set of fins and the crosspieces to rotate around a common axis.
In some embodiments, the plurality of crosspieces 204a, 204b comprises arms 208a, 208b to lock the tip of the needle during removal of the needle in the X-cross position. In lock position, the plurality of crosspieces 204a, 204b are secured by the arms 208a, 208b. In some embodiments, the clip 108 is made of steel. In some embodiments, the plurality of crosspieces comprises two arms having equal lengths. In some embodiments, the two arms are operably connected to each other via a spring-mechanism, and the spring mechanism is configured to maintain a default position of the arms. In some embodiments, the crosspieces comprise two arms having variable lengths.
Referring to
The cage 110 is configured to encapsulate the clip 108 during removal of the needle 106. The cage 110 refers to an additional protective mechanism that is used in conjunction with the clip 108 to enhance needlestick prevention and minimize the risk of accidental injuries. This cage 110 adds an extra layer of physical protection over the needle 106 and the clip 108, further reducing the potential for needlestick incidents. In other words, a combination of the clip 108 and the cage 110 provide a passive safety technology with double protection.
In some embodiments, the cage 110 is typically designed to fit securely over the clip 108, enclosing the needle 106 and clip 108 within a protective housing. In some embodiments, the cage 110 may use a hinging mechanism that allows the cage 110 to be easily opened and closed like a clamshell. In some other embodiments, the cage 110 may have a snap-on design that fits tightly over the clip 108.
In some embodiments, the cage 110 is made of durable materials, such as plastic, that provide a physical barrier to prevent accidental contact with the needle 106. In some embodiments, the cage 110 is made of materials selected from a group of polypropylene random copolymer, polypropylene homopolymer, high-density polyethylenek-resin (clear styrene-butadiene block copolymer), polycarbonate, polyoxymethylene, and acrylonitrile butadiene styrene.
In some embodiments, the cage 110 may have mechanisms to securely lock the needle 106 in place, ensuring that the needle 106 remains covered and protected until it is intentionally removed by the healthcare professional.
The cage 110 comprises a first aperture 300 and a second aperture 302. The second aperture 302 is formed in a direction opposite to a location of the first aperture 300 and slightly lower to the location of the first aperture 300. The cage further comprises and one or more slits 304 formed at a bottom of the cage 110. The one or more slits 304 affixes the cage 110 to the hub 104. In some embodiments, the first aperture 300 and the second aperture 302 may have a circular shape. In some other embodiments, the first aperture 300 and the second aperture 302 may have a square shape. In some embodiments, each of the first aperture 300 and the second aperture 302 may have an interchangeably square shape or circular shape. Specifically, in the embodiment of
In some embodiments, the cage 110 has a frustum-conical structure and comprises a top surface 306 having a hole 308. In some embodiments, the hole 308 has a diameter in a range from 0.1 mm to 0.5 mm. In some embodiments, the hole 308 has a diameter in a range from 0.2 mm to 0.4 mm. In some embodiments, the hole 308 has a diameter 0.3 mm. In other words, the dimensions of the first aperture 300, the second aperture 302, and the hole 308 are formed corresponding to the dimensions of structural components of clip 108, such that each of the structural components of clip 108 are complimented and are able to fit inside the cage 110 during both locking and unlocking position of the arms of the cage. In some embodiments, the cage 110 has a cylindrical structure.
The cage 110 further comprises a lateral surface 310. The first aperture 300 is formed at the lateral surface 310 and near to the top surface 306. In some embodiments, the first set of fins forms interlocking with the one or more slits and the second set of fins forms interlocking with the first aperture and the second aperture of cage 110 to stop rotational movement of the clip 108 and a lateral movement of cage 110.
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This ensures that the needle is safely concealed within the double safety mechanism, significantly reducing the risk of accidental needlestick injuries.
To summarize the above, when the needle 106 is pulled backwards, the needle 106 comes in contact with the clip 108 to lock the tip of the needle in an X-Cross position to completely prevent further axial or rotational movement with respect to each other. This leads to fixing of a needle dent on a backside of the clip 108 and thus forward and backward direction of the needle 106 is interlocked. Further, when the needle 106 is withdrawn in a backward direction, the cage 110 gets activated, and the tip of the needle 106 is covered by the cage 110. At this position, the cage 110 and the clip 108 are in an irreversible locking position.
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The present disclosure relates to an innovative intravenous (IV) catheter with an integrated dual-safety mechanism designed to reduce the risk of needlestick injuries, enhance patient comfort, and streamline the catheter insertion process. The IV catheter with safety mechanism combines advanced engineering and user-centric design to provide a comprehensive solution for healthcare settings.
While particular embodiments have been described and illustrated, it should be understood that the scope of the disclosure is not limited to these specific examples. Variations and modifications within the scope of the appended claims will be readily apparent to those skilled in the art. Therefore, the present disclosure is not to be limited to the embodiments disclosed herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Accordingly, the present disclosure should not be construed as limited by the foregoing description, but rather construed in accordance with the appended claims. Specific details are given in the above description to provide a thorough understanding of the embodiments. However, it is understood that the embodiments may be practiced without these specific details. Also, it is noted that the embodiments may be described as a process which is depicted as a schematic representation. Although a depiction may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently.
The systems and devices discussed herein are examples. Various configurations may omit, substitute, or add various procedures or components as appropriate. For instance, in alternative configurations, the methods may be performed in an order different from that described, and/or various stages may be added, omitted, and/or combined. Also, features described with respect to certain configurations may be combined in various other configurations. Different aspects and elements of the configurations may be combined in a similar manner. Also, technology evolves and, thus, many of the elements are examples and do not limit the scope of the disclosure or claims. Additionally, the techniques discussed herein may provide differing results with different types of context awareness classifiers.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly or conventionally understood. As used herein, the articles “a” and “an” refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element. “About” and/or “approximately” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, encompasses variations of +20% or +10%, +5%, or +0.1% from the specified value, as such variations are appropriate to in the context of the systems, devices, circuits, methods, and other implementations described herein. “Substantially” as used herein when referring to a measurable value such as an amount, a temporal duration, a physical attribute (such as frequency), and the like, also encompasses variations of +20% or +10%, +5%, or +0.1% from the specified value, as such variations are appropriate to in the context of the systems, devices, circuits, methods, and other implementations described herein.
As used herein, including in the claims, “and” as used in a list of items prefaced by “at least one of” or “one or more of” indicates that any combination of the listed items may be used.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202321061663 | Sep 2023 | IN | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IN2023/050995 | 10/30/2023 | WO |
