Syringe with snap-in enteral connection feature
The syringe design with a non-Luer tip and enteral collar ensures safe enteral administration by preventing connection to parenteral devices, addressing the issue of misadministration and enhancing patient safety through ISO 80369-3 compliance.
Patent Information
- Application Number
- JP2022551241
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-02-26
- Filing Date
- 2021-02-24
- Publication Date
- 2025-05-20
- Estimated Expiration
- 2041-02-24
AI Technical Summary
Existing syringes lack the ability to differentiate between enteral and parenteral connections, leading to potential misadministration of fluids and medications, as they often utilize standard Luer connectors that can connect to both vascular and digestive systems.
A syringe design featuring a non-Luer tip and an enteral collar with snap-in engagement features that prevent connection to intravenous devices while allowing connection to enteral devices, ensuring compliance with ISO 80369-3 standards.
The syringe design ensures safe and accurate administration of enteral fluids and medications by preventing connection to parenteral devices, reducing the risk of misadministration and enhancing patient safety.
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Abstract
Description
[Technical field]
[0001] Aspects of the present disclosure relate to syringes with enteral connection features that prevent connection to parenteral devices. [Background technology]
[0002] Enteral nutrition involves the delivery of nutritional formulas or medications to the digestive tract. The administration of nutritional formulas to a patient can be accomplished with an enteral feeding system, assembly, or device. Enteral feeding systems typically utilize a catheter inserted into the patient's nose or mouth, through which the nutritional formula is administered to the digestive tract. A syringe or another device may be connected to the catheter to deliver the nutritional formula through the catheter. Nutritional formulas and food may also be administered directly to the patient's mouth by a syringe, which may be referred to as an "oral syringe" or "oral delivery" of medications, and does not require connection to a catheter or other device. Intravenous catheters may be inserted into a patient's vascular system to perform intravascular therapy, delivering medications through the circulatory or cardiovascular system by accessing any blood vessel. Such catheters include intravenous (IV) catheters, which are inserted into a vein, and intra-arterial catheters, which are inserted into an artery.
[0003] Syringes are used to administer liquids for various medical applications, including, for example, oral administration of nutritional formulas, storage and administration of liquids to the enteral system by enterally connecting a syringe, intravenous administration of liquids or drugs, etc. Delivery of drugs via an intravenous syringe is accomplished by connecting the distal end of the syringe to a catheter by a Luer connection. A standard male Luer tip or standard male connector has specifications provided by the International Organization for Standardization (ISO) as defined in ISO 594-1:1986 and 594-2:1998, including a 6% taper increasing from the open distal end to the proximal end, and an outer cross-sectional diameter at the tip distal end measuring between about 0.1545 inches (3.925 mm) and about 0.1570 inches (3.990 mm) for rigid materials, and between about 0.1545 inches (3.925 mm) and about 0.1585 inches (4.027 mm) for semi-rigid materials. The standard female Luer hub or standard female Luer connector may have a 6% taper decreasing from the open proximal end to the distal end and an inner cross-sectional diameter of between about 0.168 inches (4.270 mm) and about 0.170 inches (4.315 mm) at the open proximal end. For devices having a standard female Luer connector incorporating tabs or lugs for connecting to a corresponding male Luer lock connector, the outer cross-sectional diameter of the standard female Luer connector including the lugs ranges from about 0.307 inches (7.80 mm) to about 0.308 inches (7.83 mm). For devices having a standard female Luer connector that does not incorporate tabs or lugs for connecting to a corresponding male Luer lock connector, the outer cross-sectional diameter may be about 0.224 inches (5.700 mm) for rigid connectors and about 0.265 inches (6.730 mm) for semi-rigid connectors, based on the maximum outer diameter of the standard female Luer connector at the base of the ISO 584-2 lugs. The minimum length of a standard Luer tip and / or a standard Luer hub is 0.295 inches (7.500 mm) according to ISO594-1. As used herein, the phrases "standard male Luer connector", "standard male Luer tip", "standard female Luer hub" and "standard female Luer connector" shall refer to connectors having the above dimensions.
[0004] Delivery of enteral fluids, such as breast milk or formula, from a syringe having a barrel and a plunger within the barrel is accomplished by advancing the plunger into the barrel to pressurize the fluid within the barrel and expel the fluid from the distal tip of the syringe. An oral dose syringe has a barrel with a distal tip that defines a channel having a diameter substantially larger than the diameter of the needle cannula. In a typical oral syringe, the distal tip defines a smooth exterior surface that is insertable into a patient's mouth for orally introducing a medication or other fluid to the patient.
[0005] Limiting the use of standard Luer tips and connectors to vascular access systems is one consensus that has been accepted by device manufacturers and regulatory agencies. For example, the recent adoption of ISO 80369-3 provides a uniform standard for small bore connectors for enteral applications. However, the adoption of ISO 830369-3 results in a variety of syringe types for delivering fluids to patients intravenously, orally, and enterally. It is desirable to provide a syringe that can be used to connect to enteral systems with enteral connections that meet the ISO 80369-3 standard, and that can also be used on oral syringes while preventing connection to standard Luer tips and connectors. Summary of the Invention [Means for solving the problem]
[0006] A first aspect of the present disclosure is a syringe having a distal end, an open proximal end, and a sidewall extending between the distal end and the open proximal end, the sidewall defining a chamber, an outer circumferential surface, and a snap-in syringe engagement feature oriented on the outer circumferential surface adjacent the distal end; a non-luer tip oriented at the distal end of the syringe barrel, the non-luer tip being dimensioned such that the non-luer tip cannot be connected to an intravenous device, the non-luer tip defining a fluid pathway in fluid communication with the chamber; and an enteral collar defining a bore in communication with the distal end and the proximal end, the bore being complementary to and engageable with the syringe engagement feature. and an enteral collar having a snap-in enteral collar directed toward a proximal end of the enteral collar, the enteral collar engagement feature selectively biasing the syringe tip first away from the centerline of the bore upon initial axial insertion and advancement and then toward the bore centerline upon snap-in engagement with the syringe engagement feature, wherein when the syringe engagement feature is engaged with the enteral collar engagement feature, the syringe engagement feature surrounds the non-luer tip, and the enteral collar is dimensioned to allow connection to an enteral device and prevent connection to a device having a luer connector.
[0007] A second aspect of the present disclosure is a syringe having a distal end, an open proximal end, and a sidewall extending between the distal end and the open proximal end, the sidewall defining a chamber, an outer circumferential surface, and a snap-in syringe engagement feature protruding radially from the outer circumferential surface adjacent the distal end thereof; a non-luer tip directed toward the distal end of the syringe barrel, the non-luer tip being dimensioned such that the non-luer tip is incapable of connection with an intravenous device, the non-luer tip defining a fluid pathway in fluid communication with the chamber; and an enteral collar defining a bore in communication with the distal end and the proximal end, threads formed within the bore at the distal end for engaging with a threaded non-luer connector, the bore being complementary to and engageable with the syringe engagement feature, the enteral collar engagement feature being adapted to engage with the threads. and an enteral collar having an axially spaced apart snap-in enteral collar directed toward a proximal end of the enteral collar, and a concave recess formed in one engagement feature and a complementary convex protrusion formed in the other engagement feature, the enteral collar engagement feature selectively biasing the syringe tip first away from the centerline of the bore upon initial axial insertion and advancement, and then toward the bore centerline upon snap-in engagement with the syringe engagement feature, wherein when the syringe engagement feature is engaged with the enteral collar engagement feature, the syringe engagement feature surrounds the non-luer tip, and the enteral collar is sized to allow connection to an enteral device and to prevent connection to a device having a luer connector.
[0008] Another aspect of the disclosure is a syringe having a distal end, an open proximal end, and a sidewall extending between the distal end and the open proximal end, the sidewall defining a chamber, an outer circumferential surface, and a plurality of snap syringe engagement features disposed about the outer circumferential surface adjacent the distal end and projecting radially from the outer circumferential surface, each syringe engagement feature defining a recess; a non-luer tip directed toward the distal end of the syringe barrel, the non-luer tip being dimensioned such that the non-luer tip is not connectable to an intravenous device, the non-luer tip defining a fluid pathway in fluid communication with the chamber; and an enteral collar defining a bore communicating the distal and proximal ends thereof, threads formed in the bore at the distal end for engaging a threaded non-luer connector, the bore including a snap-in enteral collar engagement fuse for engaging a corresponding syringe engagement feature. and a cantilever snap joint, each cantilever snap joint including a cantilever arm and a proximal end of the arm coupled to a bore of the enteral collar and a hook coupled to a distal end of the arm, the hook protruding toward a centerline of the bore for snap-in engagement with a recess of its corresponding syringe engagement feature, the enteral collar surrounding the non-luer tip when the syringe engagement feature is engaged with the enteral collar engagement feature, the enteral collar being sized to allow connection to an enteral device and prevent connection to a device having a luer connector.
[0009] To facilitate understanding, identical reference numbers have been used, whenever possible, to designate identical elements that are common to the drawings. The drawings are not drawn to scale. [Brief description of the drawings]
[0010] [Figure 1] FIG. 1 is a perspective view of a concentrically aligned syringe and collar according to one embodiment. [Diagram 2]FIG. 2 is a side view of the syringe and collar shown in FIG. [Diagram 3] FIG. 3 is a perspective view of the syringe shown in FIG. [Figure 4] FIG. 4 is a perspective view of the collar of FIG. [Diagram 5] FIG. 5 is a perspective view of a collar according to another embodiment. [Figure 6] FIG. 6 is a perspective view of the syringe and collar shown in FIG. 1 mated together. [Figure 7] 7 is a plan axial cross-sectional view of the mating syringe and collar of FIG. 1. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0011] Before describing certain example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description as being capable of other embodiments and of being practiced or carried out in various ways.
[0012] In this disclosure, the convention is followed that the distal end of the device is the end closest to the patient and the proximal end of the device is the end away from the patient and closest to the user.
[0013] The term "unconnectable" with respect to male and female connectors refers to connectors that have a shape, size, dimension, or structure that prevents a mating connection with another connector. For example, a female luer connector has a shape, size, dimension, and / or structure that prevents a mating connection with a male non-luer connector, and therefore cannot be connected to a male non-luer connector. However, such a female luer connector has a shape, size, dimension, and / or structure that allows a mating connection to be formed with a male luer connector, and therefore can be connected to a male luer connector. In another example, a female non-luer connector has a shape, size, dimension, and / or structure that prevents a mating connection to be formed with a male luer connector, and therefore cannot be connected to a male luer connector. However, such a female non-luer connector has a shape, size, dimension, and / or structure that allows a mating connection to be formed with a male non-luer connector, and therefore can be connected to a male non-luer connector.
[0014] As used herein, the term "dimension" is intended to include the length, diameter, or width of a geometric shape or component of a geometric shape described herein. The term "cross-sectional diameter" is intended to include the measurement of the longest or greatest distance between two points on the edge of a cross-section of an object or component having a circular or non-circular cross-section.
[0015] The two points may be located on the inner or outer surface of the edge of the cross section of the object. The cross-sectional diameter of two points located on the inner surface of the edge of the cross section of an object is referred to as the "inner cross-sectional diameter" and the cross-sectional diameter of two points located on the outer surface of the edge of the cross section of an object is referred to as the "outer cross-sectional diameter". It should be appreciated that the "cross-sectional diameter" of an object having a circular cross section may be referred to as the "cross-sectional dimension" or "diameter" of the object. The terms "cross-sectional dimension", "cross-sectional diameter" and "diameter" may be used interchangeably for objects having a circular cross section.
[0016] One or more embodiments provide a syringe with an enteral collar that allows the syringe to meet ISO 80369-3 misconnection requirements. In one or more embodiments, the syringe is a non-luer tapered oral syringe with features on the barrel to accept a collar that prevents connection to an intravenous device. In one or more embodiments, the features include a snap / lock feature that allows the enteral collar to be placed and locked onto the syringe. In one or more embodiments, after the enteral collar is attached to the syringe, the collar does not translate or rotate relative to the syringe, while in other embodiments, the collar selectively translates and / or rotates relative to the syringe. According to one or more embodiments, the syringe can be utilized to withdraw, fill and administer oral medications and fluids as normal oral syringes are currently used, and after the enteral collar is attached to the syringe, the syringe is ISO 80369-3 compliant and can be utilized for enteral administration. The syringe according to one or more embodiments does not require any workflow changes at the pharmacy or patient bedside to deliver oral medications. Thus, one or more embodiments provide a syringe that can be used for two functions: oral and enteral administration.
[0017] One or more embodiments provide a syringe that can be connected to enteral feeding sets and feeding tubes. In the industry, the connection is called ENFit and complies with ISO 80369-3. According to one or more embodiments, a syringe is provided that allows the syringe to be connected to enteral devices such as enteral tubes and feeding bags, and prevents connection to parenteral devices such as intravenous lines, urinary catheters, and ventilator tubes. One or more embodiments provide an ENFit device and a syringe that complies with ISO 80369-3, where the syringe is not compatible with Luer connections, thus preventing mis-administration of enteral nutrition or medications through the wrong route. Thus, a syringe is provided with a connector that has a unique enteral-specific design that, when the collar is attached, reduces the risk of mis-connection of enteral nutrition and provides a simple way to improve patient safety. Furthermore, after the collar is connected, the collar does not allow connection with any other connector for any other clinical use, such as an intravenous device. According to one or more embodiments, a syringe is provided that when the collar is attached provides an enteral-only syringe that can be used to administer medications, flushes, hydrates, or bolus nutrition via a new ENFit feeding tube and extension set that is compliant with ISO 80369-3. One or more embodiments provide a syringe with a collar that does not connect with a standard Luer connector that is compliant with ISO standards 594 / 1 and 594 / 2. Thus, one embodiment of the present disclosure provides a syringe with a connector that has dimensions that are not compatible with standard size intravenous connectors and ports, so as to prevent accidental mechanical mating of the two connectors.
[0018] Aspects of the present disclosure relate to a syringe with an enteral collar having a male connector that prevents misconnection to other incompatible female connectors. A male connector is defined herein as a male connector that has a different shape, size, dimensions or configuration than the incompatible female connector. The incompatible female connector may include a standard female Luer connector conforming to ISO 594-1:1986 and 594-2:1998.
[0019] In one or more embodiments, the non-compatible collar with female connector may have a shape, size, dimension, or structure that does not conform to ISO 594-1:1986 or ISO 594-2:1998. In such embodiments, the non-compatible female connector may have a shape, size, dimension, or structure that prevents it from being characterized or defined as a female Luer connector as defined above or according to ISO 594-1:1986 or ISO 594-2:1998. In one or more specific embodiments, the non-compatible female connector may have a different length and / or cross-sectional diameter than a female Luer connector as defined above or according to ISO 594-1:1986 or ISO 594-2:1998. In more specific embodiments, the non-compatible female connector may have a different taper than a male Luer connector as defined above or according to ISO 594-1:1986 or ISO 594-2:1998. In more specific embodiments, the non-compatible female connector may have a less steep taper (e.g., a 5% taper) than a female Luer connector defined above or in accordance with ISO 594-1:1986 or ISO 594-2:1998, a smaller cross-sectional diameter than a female Luer connector defined above or in accordance with ISO 594-1:1986 or ISO 594-2:1998, and / or a longer length than a female Luer connector defined above or in accordance with ISO 594-1:1986 or ISO 594-2:1998.
[0020] 1-3 and 7, a syringe 10 comprises a syringe barrel 12 having a distal end 14, an open proximal end 16, and a sidewall 18 extending between the distal end 14 and the open proximal end 16. The sidewall 18 defines an interior chamber 20 and a snap-in syringe engagement feature 22 adjacent the distal end 14 of the syringe barrel 12. The syringe engagement feature 22 comprises a pair of opposing concave recesses 23, each of which comprises a trapezoidal cross-sectional shape including an undercut surface 24, as shown in this embodiment. In other embodiments, the concave recesses 23 have other cross-sectional shapes, for example, a square or semicircular or triangular shape. In some embodiments, the syringe engagement feature 22 has one concave recess or two or more recesses. In some embodiments, the concave recesses of the syringe engagement feature 22 are continuous about the circumference of the syringe barrel 12.
[0021] A syringe engagement feature 22, including an embedded concave recess 23, projects radially outward from the outer circumferential surface of the syringe barrel 12, which defines a circumferential sloped surface 25 adjacent to a tapered, non-luer tip 26. The non-luer tip 26 is at the distal end 14 of the syringe barrel 12. The syringe engagement feature 22 is located between the open proximal end 16 and the distal end 14 of the syringe barrel, adjacent to the non-luer tip 26. The non-luer tip 26 is dimensioned such that it cannot be connected to an intravenous device. The non-luer tip 26 defines a fluid pathway 29 in fluid communication with the chamber 20. In some embodiments, the syringe engagement feature 22 does not project outward from the outer circumferential surface of the syringe barrel. An anti-rotation key 28 projects from the syringe barrel 12. Some embodiments of the syringe do not have an anti-rotation key.
[0022] 3-5, the syringe 10 further comprises an enteral collar 30 having a distal end 32 and a proximal end 34. A through bore 35 defined within an inner surface of the collar 30 communicates with the distal end 32 and the proximal end 34 of the collar 30. The proximal end 34 of the enteral collar 30 has a snap-in enteral collar engagement feature 36 that is complementary to and engageable with the snap-in syringe engagement feature 22.
[0023] As illustrated in Figures 6 and 7, when the syringe engagement feature 22 engages with the enteral collar engagement feature 36, the enteral collar 30 surrounds the non-luer tip 26. The enteral collar 30 is outside the fluid path 29 and is not in fluid communication with the chamber 20. Fluid contained in the chamber 20 of the syringe 10 flows through the distal tip 27, and fluid flowing through the distal tip 27 does not contact the collar 30. Because the axial length of the non-luer tip 26 is greater than the axial length of the bore 35 of the enteral collar 30, the non-luer tip protrudes from the distal end 32 of the enteral collar after engagement of the engagement features of the respective syringe engagement feature 22 and the enteral collar 36. The enteral collar 30 is sized to allow connection to an enteral device and prevent connection to a device having a luer connector.
[0024] The enteral collar engagement feature 36 and the syringe engagement feature 22 include complementary snap-in / snap-fit mating features selected from a cantilever snap joint, a torsion snap joint, and an annular snap joint. Generally, each enteral collar engagement feature 36 and syringe engagement feature 22 in the form of a snap-in / snap-fit feature comprises a concave recess formed on one of the engagement features and a complementary mating convex protrusion formed on the other of the engagement features. With reference to the embodiment shown in Figures 4-7, each concave recess 23 of the syringe engagement feature 22 mates with a convex hook or other protuberance formed on the corresponding enteral collar engagement feature 36.
[0025] In the embodiment of FIGS. 4-7, the enteral collar engagement feature 36 is a discontinuous annular snap joint 38 including at least one opposed cantilever snap joint 40. Each of the snap joints 40 includes a cantilever arm 42 with a proximal end 44 coupled to a surface of the collar bore 35 of the enteral collar 30 and a hook 46 coupled to a distal end of the arm. Each hook 46 projects toward the centerline of the bore 35 for snap-in engagement with a corresponding concave recess 23 of the syringe engagement feature 22. Such snap-in engagement is achieved by inserting and advancing the non-luer tip 26 of the syringe barrel 12 proximally into the bore 35. As the syringe barrel 12 advances into the bore 35 on its respective angled ramp 25, the syringe engagement feature 22 abuts against the tip of its corresponding hook 46, which deflects and biases its cantilever arm 42 away from the centerline of the bore. As each hook 46 axially clears its corresponding opposing inclined ramp 25, the cantilever arm 42 self-biases and snaps into a corresponding recess 23 of the syringe engagement feature 22 (see FIG. 7 ) to achieve a snap-fit / snap-in engagement of the mating enteral collar engagement feature 36 and its associated syringe engagement feature 22. Upon snap-in engagement of the respective syringe and enteral collar engagement features 22 and 36, the undercut surface 24 abuts the corresponding axial surface 48 of the hook 46. In other embodiments, the orientation of the respective recesses and convex ridges or hooks is reversed such that the cantilever arm 42 incorporates a recess or opening while the syringe engagement feature incorporates a mating hook that projects radially outward relative to the centerline of the bore 35. Thus, in some embodiments, the syringe engagement feature comprises a recess formed in the outer circumferential surface of the barrel that captures an opposing protruding hook formed in the cantilever arm of the cantilever snap joint.
[0026] While a discontinuous annular snap joint 38 is shown in the embodiment of Figures 4 and 5, other embodiments incorporate a single cantilever snap joint or two or more cantilever snap joints. In some embodiments incorporating multiple snap joints, they are oriented circumferentially around the bore 35 of the enteral collar 30: symmetrically or asymmetrically. The enteral collar 130 of Figure 5 has a pair of opposing cantilever arms 42. The embodiment of the enteral collar 30 of Figure 4 incorporates radially oriented relief cuts 50 in its proximal end 34 between the cantilever arms 42 of the discontinuous annular snap joint 38. Thus, the collar 30 effectively comprises a total of four cantilever arms 42, one pair separated by a relief cut 50 on one circumferential side and another pair separated by a 180 degree oriented relief cut 50 on the other side. The relief cuts 50 facilitate easier radial deflection of the enteral collar 30 and deflection of its cantilever arms 42 compared to the embodiment of the enteral collar 130 of FIG. 5 that does not have a relief cut. In some embodiments, the enhanced radial deflection of the enteral collar 30 and cantilever arms 42 permitted by the relief cuts 50 facilitates insertion and advancement of the syringe barrel 12 into the collar. In other embodiments, the enhanced radial deflection and flexing of the cantilever arms 42 permitted by the relief cuts 50 improves the ability to separate the syringe barrel 12 and the enteral collar 30. Conversely, in the embodiment of FIG. 7, after engagement of the syringe engagement feature 22 and the enteral collar engagement feature 36, the enteral collar 30 cannot be removed from the syringe 10, and the abutting surfaces of the undercut surfaces 24 and the corresponding axial surfaces 48 of the hooks 46 inhibit each cantilever arm 42 from disengaging from its corresponding recess 23.In different exemplary embodiments, the overall force required to relatively advance and engage the syringe barrel 12 and collar 30 or collar 130 is selectively varied during syringe design by varying one or more of the axial length and / or cross-section of the cantilever arm 42, the dimensions of the fillet radius of the attachment of the proximal end 44 of the cantilever arm to the bore 35, and the relative engagement surface area of the axial surface 48 of the hook 46 relative to the undercut surface 24 of the recess 23. In some embodiments, shifting of the hook 46 relative to the concave recess 23 can vary the hook engagement during insertion and advancement of the collar.
[0027] Each of the enteral collar embodiments 30 and 130 of Figures 4 and 5 incorporates a keyway 52 on its respective proximal end 34 that mates with an anti-rotation key 28 (see Figure 3) of the syringe barrel 12 after insertion of the syringe barrel into the collar and mating engagement of the syringe engagement feature 22 and the enteral collar engagement feature 36. After such engagement, the enteral collar 30 or 130 is not rotatable relative to the syringe 10. In other embodiments, the anti-rotation feature is achieved by forming corresponding mating male and female asymmetric cross-sectional shapes on the outer periphery of the syringe barrel 12 and within the bore 35 of the enteral collar embodiment 30 or 130.
[0028] As illustrated in FIGS. 1, 4 and 7, the surface of the enteral collar 30 defining the bore 35 includes female collar threads 54 at the collar's distal end 32 for engaging a male-threaded non-luer connector (not shown). The threads 54 are axially spaced from an enteral collar engagement feature 36 oriented on the collar's proximal end 34. In other embodiments, the enteral collar 30 incorporates external male threads or lugs rather than internal female threads with syringe threads (not shown) adjacent the distal end 14 of the syringe barrel 12. In other embodiments, the enteral collar 30 incorporates a manifold structure (not shown) at its distal end 32 with multiple male and / or female threaded surfaces for coupling to multiple non-luer connectors. In certain embodiments, the enteral collar 30 with male threads or lugs provides an ENfit connection that complies with ISO 80369-3, providing a male connector that is matable with a female ENfit connector that complies with ISO 80369-3.
[0029] Syringes typically hold some amount of medication in the space within the chamber between the plunger and the distal end of the chamber, and these spaces are typically referred to as the "dead space" of the syringe. In one or more embodiments, if the chamber 20 of the syringe 10 has a volume of less than 5 ml and there is a dead space area that holds fluid within the chamber after the fluid is expelled from the chamber, the dead space area contains less than 0.07 ml of fluid. In one or more embodiments, a syringe 10 with a chamber 20 having a volume in the range of 5 ml and a volume less than 10 ml has a dead space area of 0.075 ml or less. In one or more embodiments, a syringe 10 with a chamber 20 having a volume less than 20 ml and more than 10 ml has a dead space area of 0.10 ml or less.
[0030] In one or more embodiments, the syringes described herein may be connected to various known enteral devices, such as feeding bags and feeding catheters, which is typically accomplished by connecting an enteral collar, as described herein, to a flexible tube. The components of the syringe 10, including the syringe barrel 12 and the enteral collars 30, 130, are made of a variety of materials suitable for medical and healthcare applications. For example, the female or male adapters can be manufactured from medical grade materials such as nylon, polypropylene, polycarbonate, polyvinylidene fluoride, acrylonitrile butadiene styrene, and polyvinyl chloride.
[0031] References throughout this specification to "one embodiment," "a particular embodiment," "one or more embodiments," or "an embodiment" mean that the particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. That is, the appearances of phrases such as "in one or more embodiments," "in a particular embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.
[0032] Although the present disclosure has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the present invention. Therefore, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.
Claims
1. A syringe, a syringe barrel having a distal end, an open proximal end, and a sidewall extending between the distal end and the open proximal end, the sidewall defining a chamber, an outer circumferential surface, and a snap-in syringe engagement feature oriented on the outer circumferential surface adjacent the distal end; a non-luer tip oriented at a distal end of the syringe barrel, the non-luer tip being dimensioned such that the non-luer tip is not connectable to an intravenous device, the non-luer tip defining a fluid pathway in fluid communication with the chamber; an enteral collar defining a distal end and a bore communicating with its proximal end, the bore having a snap-in enteral collar engagement feature oriented at the proximal end of the enteral collar that is complementary to and engageable with the syringe engagement feature, the enteral collar engagement feature selectively deflecting initially away from a centerline of the bore upon initial axial insertion to advance the tip of the syringe into the bore and then deflecting toward the centerline of the bore upon snap-in engagement with the syringe engagement feature, each of the enteral collar engagement and syringe engagement features comprising a concave recess formed in the outer circumferential surface of the barrel and a complementary mating convex protrusion configured to comprise a cantilever arm coupled to the bore of the enteral collar, the concave recess capturing an opposing protruding hook formed on the cantilever arm; A syringe sized such that when the syringe engagement feature is engaged with the enteral collar engagement feature, the enteral collar surrounds the non-luer tip, the enteral collar allowing connection to an enteral device and preventing connection to a device having a luer connector.
2. The syringe of claim 1 , wherein the enteral collar engagement feature comprises at least one cantilever snap joint.
3. The syringe of claim 2 , further comprising a plurality of cantilever snap joints oriented circumferentially around the bore of the enteral collar.
4. The syringe of claim 3 , wherein the enteral collar further comprises a relief cut formed in the proximal end thereof between a pair of cantilever snap joints.
5. 2. The syringe of claim 1, wherein the proximal end of the enteral collar includes the syringe engagement feature and the distal end of the enteral collar includes threads formed in the bore thereof for engaging a threaded non-luer connector.
6. The syringe of claim 5 , wherein all of the threads are axially separated from the enteral collar engagement feature.
7. The syringe of claim 1 , wherein the enteral collar is not separable from the syringe after mating engagement of the syringe engagement feature and the enteral collar engagement feature.
8. 2. The syringe of claim 1, further comprising mating anti-rotation features formed on the outer circumferential surface of the syringe barrel and the bore of the enteral collar, respectively, such that the enteral collar cannot rotate relative to the syringe after mating engagement of the syringe engagement feature and the enteral collar engagement feature.
9. 2. The syringe of claim 1, wherein the chamber has a volume in the range of less than 5 mL and 10 mL and has a dead space area that retains fluid in the chamber after fluid is expelled from the chamber, the dead space area containing less than 0.075 mL of fluid.
10. 2. The syringe of claim 1, wherein the axial length of the non-luer tip is greater than the axial length of the bore of the enteral collar such that the non-luer tip protrudes from the distal end of the enteral collar after engagement of the engagement features of the respective syringe and the enteral collar.
11. The syringe of claim 1 , wherein the enteral collar is external to the fluid pathway and is not in fluid communication with the chamber.
12. The syringe of claim 1 , further comprising a radial relief cut formed in the proximal end of the enteral collar.
13. A syringe, a syringe barrel having a distal end, an open proximal end, and a sidewall extending between the distal end and the open proximal end, the sidewall defining a chamber, an outer circumferential surface, and a snap-in syringe engagement feature on the outer circumferential surface adjacent the distal end; a non-luer tip oriented at a distal end of the syringe barrel, the non-luer tip being dimensioned such that the non-luer tip is not connectable to an intravenous device, the non-luer tip defining a fluid pathway in fluid communication with the chamber; an enteral collar defining a distal end and a bore in communication with a proximal end thereof and having a centerline, threads formed in the bore on the distal end thereof, the bore having a snap-in, enteral collar engagement feature oriented at the proximal end of the enteral collar, the snap-in, enteral collar engagement feature being complementary to and engageable with the syringe engagement feature for engaging a threaded non-luer connector, the enteral collar engagement feature being axially separated from the threads; a recess formed on one of the engagement features and a complementary mating convex protrusion on the other of the engagement features, the complementary mating convex protrusion comprising at least one cantilever snap joint including a cantilever arm, a proximal end of the cantilever arm coupled to the bore of the enteral collar, and a hook coupled to a distal end of the arm for snap-in engagement with the recess, the hook protruding toward the centerline of the bore; the enteral collar engagement feature being initially selectively biased away from a centerline of the bore upon initial axial insertion to advance the tip of the syringe into the bore and then biased toward the centerline of the bore upon snap-in engagement with the syringe engagement feature; A syringe, the enteral collar surrounding the non-luer tip when the syringe engagement feature is engaged with the enteral collar engagement feature, the enteral collar sized to allow connection to an enteral device and prevent connection to a device having a luer connector.
14. The syringe of claim 13 , wherein the syringe engagement feature comprises the recess.
15. 14. The syringe of claim 13, further comprising a plurality of cantilever snap joints circumferentially about the bore of the enteral collar and corresponding recesses in the syringe engagement feature.
16. 15. The syringe of claim 14, further comprising a relief cut formed in the proximal end of the enteral collar between a pair of cantilever snap joints.
17. The syringe of claim 16, wherein each of the cantilever snap joints comprises a discontinuous annular snap joint.
18. 20. The syringe of claim 17, further comprising a relief cut formed in the proximal end of the enteral collar between a pair of the cantilever snap joints.
Citation Information
Patent Citations
Syringe with enteral connection function
JP2019528991A