Syringe with snap-fit intestinal connection feature
By designing a syringe with a non-Luer tip and a complementary intestinal loop, the problem of incorrect syringe connection in intravenous and intra-intestinal delivery was solved, achieving safe intravenous delivery and compatibility with oral administration.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2021-02-24
- Publication Date
- 2026-05-26
Smart Images

Figure CN115103700B_ABST
Abstract
Description
Technical Field
[0001] Various aspects of this disclosure relate to syringes having an enteric connection feature that prevents connection to non-enteric devices. Background Technology
[0002] Enteral nutrition involves delivering nutritional formula or medications into the gastrointestinal tract. Enteral feeding systems, components, or devices can be used to administer nutrients to a patient. Enteral feeding systems typically utilize a catheter inserted into the patient's nose or mouth to deliver nutrients into the gastrointestinal tract. A syringe or other device can be attached to the catheter to deliver nutrients through it. Nutrients and food can also be given directly into the patient's mouth via a syringe, which may be referred to as an "oral syringe" or "oral delivery" for medications, and does not require connection to a catheter or other device. Intravenous catheters are inserted into a patient's vascular system for endovascular treatment, delivering medications through the circulatory or cardiovascular system by entering any blood vessel. Such catheters include intravenous (IV) catheters inserted into veins and intraarterial catheters inserted into arteries.
[0003] Syringes are used to deliver fluids for a variety of medical applications, including, for example, oral delivery of nutrients, storage and delivery of fluids to the enteral system by connecting the syringe to an enteral connector, and intravenous delivery of fluids or drugs. Drug delivery via intravenous syringes involves connecting the distal end of the syringe to a catheter via a Luer connector. Standard male Luer tips or standard male connectors have specifications provided by the International Organization for Standardization (ISO) as defined in ISO 594-1:1986 and 594-2:1998, including a 6% taper that gradually increases from the distal to the proximal end of the opening, and an outer cross-sectional diameter at the distal end of the tip that is between approximately 0.1545 inches (3.925 mm) and approximately 0.1570 inches (3.990 mm) for rigid materials and between approximately 0.1545 inches (3.925 mm) and approximately 0.1585 inches (4.027 mm) for semi-rigid materials. A standard female Luer hub or standard female Luer connector may have a 6% taper that gradually decreases from the proximal end of the opening to the distal end, and an inner cross-sectional diameter measured at the proximal end of the opening between about 0.168 inches (4.270 mm) and about 0.170 inches (4.315 mm). In an apparatus having a standard female Luer connector including tabs or lugs for connection to a corresponding male Luer locking connector, the outer cross-sectional diameter of the standard female Luer connector including the lugs is in the range of about 0.307 inches (7.80 mm) to about 0.308 inches (7.83 mm). In an apparatus having a standard female Luer connector not including tabs or lugs for connection to a corresponding male Luer locking connector, the outer cross-sectional diameter of the standard female Luer connector at the bottom of the lug, according to ISO 594-2, may be about 0.224 inches (5.700 mm) for a rigid connector and about 0.265 inches (6.730 mm) for a semi-rigid connector. According to ISO 594-1, the minimum length of a standard Luer tip and / or standard Luer hub is 0.295 inches (7.500 mm). 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] Intestinal fluids, such as breast milk or formula, are delivered from a syringe having a barrel and a plunger within it. This is achieved by advancing a plunger into a barrel to pressurize the fluid within and expelling the fluid from the distal tip of the syringe. Oral dosing syringes have a barrel with a distal tip that defines a channel whose diameter is substantially larger than the diameter of a needle cannula. In typical oral syringes, the distal tip defines a smooth outer surface that can be inserted into a patient's mouth to orally introduce medication or other fluids into the patient's body.
[0005] Restricting the use of standard Luer tips and connectors to vascular access systems is a consensus accepted by device manufacturers and regulatory agencies. For example, the recently adopted ISO 80369-3 provides a unified standard for small-hole connectors for enteral applications. However, adopting ISO 80369-3 would result in multiple types of syringes delivering fluids to patients via intravenous, oral, and enteral routes. There is a need to provide a syringe that can be used to connect to enteral systems with enteral connections conforming to ISO 80369-3, and also as an oral syringe, while preventing connection to standard Luer tips and connectors. Summary of the Invention
[0006] A first aspect of this disclosure relates to a syringe comprising: a syringe barrel having a distal end, a proximal opening end, and a sidewall extending between the distal end and the proximal opening end, the sidewall defining a chamber, an outer circumferential surface, and snap-fit syringe engagement features oriented on the outer circumferential surface near its distal end; a non-Luer tip oriented at the distal end of the syringe barrel, the non-Luer tip being sized such that it cannot be connected to an intravenous device, the non-Luer tip defining a fluid path in fluid communication with the chamber; and an intestinal ring defining an orifice communicating with its distal and proximal ends, the orifice having an orifice oriented at the proximal end of the intestinal ring. The device features a snap-fit intestinal cuff engagement feature that is complementary to and engages with a syringe engagement feature. The intestinal cuff engagement feature is selectively biased initially in a direction away from the centerline of the hole when the syringe tip is initially axially inserted and advanced into the hole, and then biased towards the centerline of the hole when snap-fitted with the syringe engagement feature. When the syringe engagement feature engages with the intestinal cuff engagement feature, the intestinal cuff surrounds the non-Luer tip, and the size of the intestinal cuff is designed to allow connection to an intestinal device and prevent connection to a device with a Luer connector.
[0007] A second aspect of this disclosure relates to a syringe comprising: a syringe barrel having a distal end, a proximal opening end, and a sidewall extending between the distal end and the proximal opening end; the sidewall defining a chamber, an outer circumferential surface, and a snap-fit syringe engagement feature projecting radially from the outer circumferential surface near its distal end; a non-Luer tip oriented at the distal end of the syringe barrel, its dimensions designed such that the non-Luer tip cannot be connected to an intravenous device, the non-Luer tip defining a fluid path in fluid communication with the chamber; and an intestinal collar defining a hole communicating with its distal and proximal ends, threads formed in the hole at its distal end for engaging a threaded non-Luer connector, the hole having a snap-fit intestinal collar engagement feature oriented at the proximal end of the intestinal collar. The intestinal collar engagement feature is complementary to and engageable with the syringe engagement feature, the intestinal collar engagement feature being axially separate from the thread; a recessed groove is formed on one of the engagement features and a complementary mating protrusion is formed on the other of the engagement features; the intestinal collar engagement feature is selectively biased first in a direction away from the centerline of the hole when the syringe tip is initially axially inserted and advanced into the hole, and then biased in a direction toward the centerline of the hole when snapped into engagement with the syringe engagement feature; and when the syringe engagement feature engages with the intestinal collar engagement feature, the intestinal collar surrounds the non-Luer tip, and the size of the intestinal collar is designed to allow connection to an intestinal device and prevent connection to a device with a Luer connector.
[0008] Another aspect of this disclosure relates to a syringe comprising: a barrel having a distal end, a proximal opening end, and sidewalls extending between the distal end and the proximal opening end; the sidewalls defining a chamber, an outer circumferential surface, and a plurality of snap-fit syringe engagement features oriented around and radially projecting from the outer circumferential surface near the distal end, each syringe engagement feature defining a recess; a non-Luer tip oriented at the distal end of the syringe barrel, sized such that the non-Luer tip cannot be connected to an intravenous device, the non-Luer tip defining a fluid path in fluid communication with the chamber; and an intestinal collar defining a hole communicating with its distal and proximal ends, threads formed in the hole at its distal end for engaging a threaded non-Luer connector, the hole... It features a snap-fit intestinal cuff engagement feature for engagement with a corresponding syringe engagement feature, the intestinal cuff engagement feature being axially separated from the thread and oriented at the proximal end of the intestinal cuff; the intestinal cuff engagement feature is formed as a discontinuous annular snap-fit connector including multiple cantilever snap-fit connectors, each cantilever snap-fit connector including a cantilever, a proximal end of the cantilever connecting to a hole in the intestinal cuff, and a hook connecting to the distal end of the cantilever, the hook protruding toward the centerline of the hole for snap-fit engagement with a groove of its corresponding syringe engagement feature; and when the syringe engagement feature engages with the intestinal cuff engagement feature, the intestinal cuff surrounds a non-Luer tip, and the size of the intestinal cuff is designed to allow connection to an intestinal device and prevent connection to a device with a Luer connector. Attached Figure Description
[0009] Figure 1 A perspective view of a concentrically aligned syringe and collar according to one embodiment;
[0010] Figure 2 for Figure 1 The side view of the syringe and collar shown;
[0011] Figure 3 for Figure 1 A perspective view of the syringe shown;
[0012] Figure 4 for Figure 1 A perspective view of the collar;
[0013] Figure 5 A perspective view of a collar according to another embodiment;
[0014] Figure 6 for Figure 1 The perspective view shown depicts the syringe and collar mating together; and
[0015] Figure 7 for Figure 1 A planar axial cross-sectional view of the syringe and collar that fit together.
[0016] For ease of understanding, the same reference numerals have been used where possible to denote common elements in the figures. These figures are not drawn to scale. Detailed Implementation
[0017] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or processes set forth in the following description. This disclosure can have other embodiments and can be practiced or implemented in various ways.
[0018] In this disclosure, a convention is followed in which the distal end of the device is the end closest to the patient, while the proximal end of the device is the end furthest from the patient and closest to the practicing physician.
[0019] The term "non-connectable" in relation to male and female connectors refers to a connector having a shape, size, dimension, or structure that prevents mating connection with another connector. For example, a female Luer connector has a shape, size, dimension, and / or structure that prevents mating connection with a male non-Luer connector and is therefore non-connectable relative to the male non-Luer connector. However, such a female Luer connector has a shape, size, dimension, and / or structure that allows mating connection with a male Luer connector and is therefore connectable relative to the male Luer connector. In another example, a female non-Luer connector has a shape, size, dimension, and / or structure that prevents mating connection with a male Luer connector and is therefore non-connectable relative to the male Luer connector. Such a female non-Luer connector has a shape, size, dimension, and / or structure that allows mating connection with a male non-Luer connector and is therefore a connectable connector relative to the male non-Luer connector.
[0020] As used herein, the term “dimension” shall include the length, diameter, or width of a geometric shape or a component with the geometric shape described herein. The term “cross-sectional diameter” shall include a measurement of the longest or maximum distance between two points on the edge of the cross-section of an object or component having a circular or non-circular cross-section.
[0021] The two points may be located on the inner or outer surface of the cross-sectional edge of the object. The cross-sectional diameter of the two points located on the inner surface of the cross-sectional edge of the object should be referred to as the "inner diameter of the cross-section," while the cross-sectional diameter of the two points located on the outer surface of the cross-sectional edge of the object should be referred to as the "outer diameter of the cross-section." It should be recognized that the "cross-sectional diameter" of an object with 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" are used interchangeably for objects with a circular cross-section.
[0022] One or more embodiments provide a syringe with an enteral loop that enables the syringe to meet the ISO 80369-3 error connection requirements. In one or more embodiments, the syringe is a non-Luer cone oral syringe with a feature on the barrel that receives a loop to prevent connection to an intravenous device. In one or more embodiments, the feature includes a snap-fit / locking feature that allows the enteral loop to be placed and locked onto the syringe. In one or more embodiments, after the enteral loop is attached to the syringe, the loop will not translate or rotate relative to the syringe; however, in other embodiments, the loop may selectively translate and / or rotate relative to the syringe. According to one or more embodiments, the syringe is capable of aspirating, filling, and administering oral medications and fluids, as with conventional oral syringes currently in use, and after attaching the enteral loop to the syringe, it will comply with ISO 80369-3 and be capable of enteral administration. The syringe according to one or more embodiments does not require any changes to the workflow at the pharmacy or bedside for the delivery of oral medications. Therefore, one or more embodiments provide a syringe that can be used for both functions (i.e., oral and enteral administration).
[0023] One or more embodiments provide a syringe capable of connecting to an enteral feeding device and a feeding tube. In the industry, this connection is referred to as ENFit and conforms to ISO 80369-3. According to one or more embodiments, a syringe is provided that allows connection to enteral tubing and enteral devices such as feeding bags, and prevents connection to non-enterolateral devices such as intravenous lines, urinary catheters, and ventilator tubing. One or more embodiments provide a syringe conforming to ENFit devices and ISO 80369-3, and this syringe is incompatible with Luer connectors, thus preventing incorrect enteral feeding or medication administration via incorrect routes. Therefore, a syringe is provided that, when a collar is attached, has a connector with a unique enteral-specific design that provides a simple way to reduce the risk of incorrect enteral tube connection and improve patient safety. Furthermore, after the collar is attached, the collar does not allow connection to any other connectors for any other clinical use (e.g., intravenous devices). According to one or more embodiments, a syringe is provided that, when attached with a collar, provides an enterospecific syringe capable of being used for drug administration, flushing, rehydration, or high-dose feeding via the new ENFit feeding tubing and extension devices conforming to ISO 80369-3. One or more embodiments provide a syringe with a collar that does not connect to standard Luer connectors conforming to ISO standards 594 / 1 and 594 / 2. Therefore, one embodiment of this disclosure provides a syringe having an intravenous connector and a port incompatible with standard sizes to prevent unintentional mechanical connection between the two.
[0024] Various aspects of this disclosure relate to a syringe having an inner collar with a male connector that prevents incorrect connection to other incompatible female connectors. A male connector herein should be defined as a male connector having a different shape, size, dimension, or structure than an incompatible female connector. Incompatible female connectors may include standard female Luer connectors conforming to ISO 594-1:1986 and 594-2:1998.
[0025] In one or more embodiments, the incompatible ferrule with the female connector may have a shape, size, dimension, or construction that does not conform to ISO 594-1:1986 or ISO 594-2:1998. In such embodiments, the incompatible female connector may have a shape, size, dimension, or construction 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 incompatible 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 incompatible female connector may have a different taper than a Luer connector as defined above or according to ISO 594-1:1986 or ISO 594-2:1998. In even more specific embodiments, incompatible female connectors may have, for example, a gentler taper (e.g., 5% taper) than female Luer connectors as defined above or according to ISO 594-1:1986 or ISO 594-2:1998, a smaller cross-sectional diameter than female Luer connectors as defined above or according to ISO 594-1:1986 or ISO 594-2:1998, and / or a longer length than female Luer connectors as defined above or according to ISO 594-1:1986 or ISO 594-2:1998.
[0026] refer to Figure 1-3 and Figure 7The syringe 10 includes a syringe barrel 12 having a distal end 14, a proximal opening 16, and a sidewall 18 extending between the distal end 14 and the proximal opening 16. The sidewall 18 defines an internal chamber 20 and a snap-fit syringe engagement feature 22 near the distal end 14 of the syringe barrel 12. The syringe engagement feature 22 includes a pair of opposing recesses 23, each including a trapezoidal cross-sectional profile as shown in this embodiment, with an undercut surface 24. In other embodiments, the recesses 23 have other cross-sectional profiles, such as square, semi-circular, or triangular profiles. In some embodiments, the syringe engagement feature 22 has one or more recesses. In some embodiments, the recesses of the syringe engagement feature 22 are continuous around the circumference of the syringe barrel 12.
[0027] A syringe engagement feature 22 (including its recessed groove 23) projects radially outward from the outer circumferential surface of the syringe barrel 12; it defines a circumferentially inclined ramp surface 25 abutting a tapered non-Luer tip 26. The non-Luer tip 26 is located at the distal end 14 of the syringe barrel 12. The syringe engagement feature 22 is located between the proximal end 16 and the distal end 14 of the syringe barrel opening, abutting the non-Luer tip 26. The non-Luer tip 26 is sized such that it cannot be connected to an intravenous device. The non-Luer tip 26 defines a fluid path 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 protrudes from the syringe barrel 12. Some embodiments of the syringe do not have an anti-rotation key.
[0028] refer to Figure 3-5 The syringe 10 further includes an intestinal loop 30 (loop) having a distal end 32 and a proximal end 34. A through hole 35 (hole) defined in the inner surface of the loop 30 communicates with the distal end 32 and the proximal end 34 of the loop 30. The proximal end 34 of the intestinal loop 30 has a snap-fit intestinal loop engagement feature 36, which is complementary to and engages with the snap-fit syringe engagement feature 22.
[0029] like Figure 6 and Figure 7As shown, when the syringe engagement feature 22 engages with the intestinal collar engagement feature 36, the intestinal collar 30 surrounds the non-Luer tip 26. The intestinal collar 30 is outside the fluid path 29 and is not in fluid communication with the chamber 20. The fluid contained in the chamber 20 of the syringe 10 flows through the distal tip 27; the fluid flowing through the distal tip 27 does not contact the collar 30. The axial length of the non-Luer tip 26 is greater than the axial length of the orifice 35 of the intestinal collar 30, such that after the respective syringe engagement feature 22 and the intestinal collar 36 engagement feature are engaged, the non-Luer tip protrudes from the distal end 32 of the intestinal collar. The size of the intestinal collar 30 is designed to allow connection to an intestinal device and to prevent connection to a device with a Luer connector.
[0030] The intestinal cuff engagement feature 36 and the syringe engagement feature 22 include complementary snap-fit / lock-fit features selected from cantilever snap-fit connectors, torsion snap-fit connectors, and annular snap-fit connectors. Typically, the intestinal cuff engagement 36 and the syringe engagement feature 22, in the form of snap-fit / lock-fit features, each include a recessed groove formed on one of the engagement features and a complementary mating protrusion formed on the other. Reference Figure 4-7 In the embodiment shown, each corresponding recessed groove 23 of the syringe engagement feature 22 engages with a protruding hook or other protrusion formed in the corresponding intestinal cuff engagement feature 36.
[0031] exist Figure 4-7 In one embodiment, the intestinal cuff engagement feature 36 is a discontinuous annular snap-fit connector 38 comprising at least a pair of opposing cantilever snap-fit connectors 40. Each snap-fit connector 40 includes a cantilever 42, wherein the proximal end 44 of the arm is engaged with the surface of the cuff hole 35 of the intestinal cuff 30, and a hook 46 is engaged with the distal end of the arm. Each hook 46 protrudes toward the centerline of the hole 35 for snap-fit engagement with its corresponding recess 23 of the syringe engagement feature 22. Such snap-fit engagement is accomplished by inserting and advancing the non-Luer tip 26 of the syringe barrel 12 proximal to the hole 35. As the syringe barrel 12 is advanced into the hole 35, each inclined ramp surface 25 of the syringe engagement feature 22 abuts against the tip of its corresponding hook 46, the hook 46 deflecting away from the centerline of the hole and biasing its cantilever 42. As each corresponding hook 46 axially passes over its corresponding opposing inclined ramp surface 25, the cantilever 42 self-biased and snaps into its corresponding recess 23 of the syringe engagement feature 22 (in Figure 7(As shown in the diagram), this completes the snap-fit / clamp-on engagement of the intestinal cuff engagement feature 36 with its associated syringe engagement feature 22. When the respective syringe engagement feature 22 and intestinal cuff engagement feature 36 snap-fit, the undercut surface 24 abuts against the corresponding axial surface 48 of the hook 46. In other embodiments, the corresponding grooves and protrusions or hooks are oriented in opposite directions, such that the cantilever 42 includes a groove or orifice, while the syringe engagement feature includes a mating hook that projects radially outward relative to the centerline of the orifice 35. Thus, in some embodiments, the syringe engagement feature includes a groove formed in the outer circumferential surface of the barrel that captures the opposing protruding hook formed in the cantilever of the cantilever snap-fit connector.
[0032] Although Figure 4 and Figure 5 The embodiments shown depict discontinuous annular snap-fit connectors 38, but other embodiments include a single cantilever snap-fit connector or two or more cantilever snap-fit connectors. In some embodiments that include multiple snap-fit connectors, they are circumferentially oriented around the holes 35 of the intestinal cuff 30: symmetrically or asymmetrically. Figure 5 The intestinal loop 130 has a pair of opposing cantilevers 42. Figure 4 An embodiment of the intestinal cuff 30 includes radially oriented release slits 50 in its proximal end 34, between the cantilever 42 of the discontinuous annular snap-fit connector 38. Thus, the cuff 30 effectively comprises four cantilever 42: a pair separated by a release slit 50 on the circumferential side, and another pair separated by 180-degree oriented release slits 50 on the opposite side. Figure 5 Compared to the embodiment of the intestinal cuff 130 without a release slit, the release slit 50 facilitates easier radial deflection of the intestinal cuff 30 and facilitates the deflection of its cantilever 42. In some embodiments, the enhanced radial deflection and cantilever 42 flexure of the intestinal cuff 30 achieved by the release slit 50 facilitate easier insertion and advancement of the syringe barrel 12 into the cuff. In other embodiments, the enhanced radial deflection and cantilever 42 flexure achieved by the release slit 50 enhance the ability to separate the syringe barrel 12 and the intestinal cuff 30. Conversely, in Figure 7In some embodiments, after the syringe engagement feature 22 and the intestinal collar engagement feature 36 engage, the intestinal collar 30 is not removed from the syringe 10; the mating surfaces of the undercut surface 24 and the corresponding axial surface 48 of the hook 46 prevent each corresponding cantilever 42 from disengaging from its corresponding recess 23. In various exemplary embodiments, the total force required to advance and engage the syringe barrel 12 and collar 30 or collar 130 relative to each other is selectively varied during syringe design by changing one or more of the axial length and / or cross-section of the cantilever 42, the radius of the fillet where the proximal end 44 of the cantilever is attached to the hole 35, and the relative engagement surface area of the axial surface 48 of the hook 46 and the undercut surface 24 of the recess 23. In some embodiments, displacement of the hook 46 relative to the recess 23 during collar insertion and advancement can alter the engagement of the hook.
[0033] Figure 4 Intestinal loop Example 30 and Figure 5 Each of the intestinal cuff embodiments 130 includes a keyway 52 on its respective proximal end 34, which engages with the anti-rotation key 28 of the syringe barrel 12 after the syringe barrel is inserted into the cuff and after the syringe engagement feature 22 and the intestinal cuff engagement feature 36 are engaged. Figure 3 (As shown in the diagram) engagement. After such engagement, the intestinal cuff 30 or 130 is non-rotatable relative to the syringe 10. In other embodiments, the anti-rotation feature is achieved by forming corresponding, mating male and female asymmetrical cross-sectional profiles on the outer circumference of the syringe barrel 12 and in the hole 35 of the intestinal cuff embodiment 30 or 130.
[0034] like Figure 1 , Figure 4 and Figure 7 As shown, the surface of the intestinal collar 30 defining the orifice 35 includes a female collar thread 54 at the distal end 32 of the collar for engaging a male threaded non-Luer connector (not shown). The thread 54 is axially spaced from an intestinal collar engagement feature 36 oriented on the proximal end 34 of the collar 30. In other embodiments, the intestinal collar 30 includes an external male thread or lug instead of an internal female thread (wherein a syringe thread (not shown) is present near the distal end 14 of the syringe barrel 12). In other embodiments, the intestinal collar 30 includes a manifold structure (not shown) at its distal end 32 having multiple male and / or female threaded surfaces for coupling to multiple non-Luer connectors. In a particular embodiment, the intestinal collar 30 with male threads or lugs provides a male connector that provides an ENfit connection conforming to ISO 80369-3 and is compatible with a female ENfit connector conforming to ISO 80369-3.
[0035] A syringe typically holds a volume of medication in the space between the plunger and the distal end of the chamber within its cavity; this space is often referred to as the syringe's "dead space." In one or more embodiments, when the chamber 20 of the syringe 10 has a volume of less than 5 ml, and a dead space region is formed that retains fluid within the chamber after it has been expelled, the dead space region contains less than 0.07 ml of fluid. In one or more embodiments, the syringe 10 having a chamber 20 with a volume ranging from 5 ml to less than 10 ml has a dead space region of less than or equal to 0.075 ml. In one or more embodiments, the syringe 10 having a chamber 20 with a volume of less than 20 ml and greater than 10 ml has a dead space region of less than or equal to 0.10 ml.
[0036] In one or more embodiments, the syringe described in this disclosure can be connected to a variety of known enteral devices, such as feeding bags and feeding catheters, typically achieved by connecting the enteral collar described herein to a flexible tubing. 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 adapter may be made of medical-grade materials such as, but not limited to, nylon, polypropylene, polycarbonate, polyvinylidene fluoride, acrylonitrile butadiene styrene, and polyvinyl chloride.
[0037] Throughout this specification, references to "one embodiment," "some embodiments," "one or more embodiments," or simply "embodiment" mean that a particular feature, structure, material, or characteristic described in connection with that embodiment is included in at least one embodiment of this disclosure. Therefore, phrases such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in an embodiment" appearing in various places throughout the specification do not necessarily refer to the same embodiment of this disclosure. Furthermore, in one or more embodiments, a particular feature, structure, material, or characteristic may be combined in any suitable manner.
[0038] Although the disclosure herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and apparatus of this disclosure without departing from the spirit and scope of this disclosure. Therefore, this disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.
Claims
1. A syringe, characterized in that, The syringe includes: 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 snap-fit syringe engagement features oriented on the outer circumferential surface near the distal end of the syringe barrel. A non-Luer tip, oriented at the distal end of the syringe barrel, is sized such that the non-Luer tip cannot be connected to an intravenous device, and the non-Luer tip defines a fluid path in fluid communication with the chamber. An intestinal cuff defining an orifice communicating with the distal and proximal ends of the intestinal cuff, the orifice having a snap-fit intestinal cuff engagement feature oriented at the proximal end of the intestinal cuff, the intestinal cuff engagement feature being complementary to and engageable with a syringe engagement feature, the intestinal cuff engagement feature selectively biased first in a direction away from the centerline of the orifice when the tip of the syringe is initially axially inserted and advanced into the orifice, and then biased in a direction toward the centerline of the orifice when snap-fitted with the syringe engagement feature, wherein the corresponding intestinal cuff engagement feature and syringe engagement feature include a recessed groove and a complementary mating protrusion formed in the outer circumferential surface of the barrel, the complementary mating protrusion including a cantilever connecting to the orifice of the intestinal cuff, and wherein the recessed groove captures an opposing protruding hook formed on the cantilever; and When the syringe engagement feature engages with the intestinal cuff engagement feature, the intestinal cuff surrounds the non-Luer tip, and the size of the intestinal cuff is designed to allow connection to an intestinal device and prevent connection to a device with a Luer connector.
2. The syringe according to claim 1, characterized in that, The intestinal loop engagement feature includes at least one cantilever snap-fit connector.
3. The syringe according to claim 2, characterized in that, The syringe further includes a plurality of cantilever snap-fit connectors circumferentially oriented around the hole of the intestinal cuff.
4. The syringe according to claim 3, characterized in that, The intestinal cuff further includes a release slit formed in the proximal end of the intestinal cuff between a pair of cantilever snap joints.
5. The syringe according to claim 1, characterized in that, The proximal end of the intestinal cuff includes the syringe engagement feature, and the distal end of the intestinal cuff includes threads formed in the hole of the intestinal cuff for engaging a threaded non-Luer connector.
6. The syringe according to claim 5, characterized in that, All of the aforementioned threads are axially separated from the intestinal collar engagement feature.
7. The syringe according to claim 1, characterized in that, After the syringe engagement feature and the intestinal cuff engagement feature are engaged, the intestinal cuff cannot be separated from the syringe.
8. The syringe according to claim 1, characterized in that, The syringe further includes mating anti-rotation features formed respectively in the outer circumferential surface of the syringe barrel and in the holes of the intestinal cuff, such that after the mating engagement of the syringe engagement feature and the intestinal cuff engagement feature, the intestinal cuff is not rotatable relative to the syringe.
9. The syringe according to claim 1, characterized in that, The chamber has a volume in the range of greater than 5 ml and less than 10 ml, and a dead space region that retains fluid in the chamber after fluid is discharged from the chamber, wherein the dead space region contains less than 0.075 ml of fluid.
10. The syringe according to claim 1, characterized in that, The axial length of the non-Luer tip is greater than the axial length of the hole in the intestinal cuff, such that after the corresponding syringe and intestinal cuff engagement features are engaged, the non-Luer tip protrudes from the distal end of the intestinal cuff.
11. The syringe according to claim 1, characterized in that, The intestinal loop is located outside the fluid path and is not in fluid communication with the chamber.
12. The syringe according to claim 1, characterized in that, The syringe further includes a radially oriented release incision formed in the proximal end of the intestinal cuff.
13. A syringe, characterized in that, The syringe includes: A syringe barrel having a distal end, a proximal opening end, and a sidewall extending between the distal end and the proximal opening end; the sidewall defines a chamber, an outer circumferential surface, and a snap-fit syringe engagement feature that projects radially from the outer circumferential surface near the distal end of the syringe barrel. A non-Luer tip, oriented at the distal end of the syringe barrel, is sized such that the non-Luer tip cannot be connected to an intravenous device, and the non-Luer tip defines a fluid path in fluid communication with the chamber. An intestinal cuff defining a hole with a centerline communicating with the distal and proximal ends of the intestinal cuff, a thread forming in the hole at the distal end of the intestinal cuff for engaging a threaded non-Luer connector, the hole having a snap-fit intestinal cuff engagement feature oriented at the proximal end of the intestinal cuff, the intestinal cuff engagement feature being complementary to and engageable with a syringe engagement feature, the intestinal cuff engagement feature being axially separate from the thread; A recessed groove is formed on one of the engagement features and a complementary mating protrusion is formed on the other engagement feature. The recessed groove includes an undercut, and the complementary mating protrusion includes at least one cantilever snap-fit connector. The at least one cantilever snap-fit connector includes a cantilever, a proximal end of the cantilever that is connected to the hole of the intestinal cuff, and a hook that is connected to the distal end of the cantilever. The hook protrudes toward the centerline of the hole for snap-fit engagement with the recessed groove. The intestinal loop engagement feature is selectively biased first in a direction away from the centerline of the hole when the tip of the syringe is initially axially inserted and advanced into the hole, and then biased towards the centerline of the hole when snap-fitted with the syringe engagement feature; and When the syringe engagement feature engages with the intestinal cuff engagement feature, the intestinal cuff surrounds the non-Luer tip, and the size of the intestinal cuff is designed to allow connection to an intestinal device and prevent connection to a device with a Luer connector.
14. The syringe according to claim 13, characterized in that, The syringe engagement feature includes the recessed groove.
15. The syringe according to claim 14, characterized in that, The syringe further includes a plurality of cantilever snap-fit connectors circumferentially surrounding the hole of the intestinal cuff and corresponding recessed grooves of the syringe engagement features.
16. The syringe according to claim 15, characterized in that, The syringe further includes a release slit formed in the proximal end of the intestinal cuff, between a pair of cantilever snap connectors.
17. The syringe of claim 15, wherein each of the cantilever snap-fit connectors comprises a discontinuous annular snap-fit connector.
18. The syringe according to claim 17, characterized in that, The syringe further includes a release slit formed in the proximal end of the intestinal cuff, between the pair of cantilever snap connectors.