needle

Abstract

A device including a housing having a first chamber and a second chamber; a needle with a first lumen and a first needle end; a blunt member with a second lumen; and a piston movable within the first chamber. The blunt member is movable with respect to the needle and is at least partially positioned within the first lumen. The blunt member is coupled to the piston for movement with the piston. When in the first configuration, the blunt member is spaced from the first needle end and the second lumen is not in fluid communication with the second chamber. When in the second configuration, the blunt member extends from the needle and the second lumen is in fluid communication with the second chamber. The device moves from the first configuration to the second configuration in response to a pressure in the second lumen.

Description

NEEDLECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to U.S. Provisional Application No. 63 / 607,195, filed December 7, 2023, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Patients with end stage kidney disease utilize dialysis as a lifesaving therapy to clean and filter the patient’s blood. Dialysis patients can have a fistula, a graft, or a catheter as their vascular access site. Arteriovenous fistulas (AV fistulas) are a common type of vascular- access site because they have the highest associated longevity and lowest morbidity and mortality for dialysis patients.

[0003] Cannulation is the needle technique in which a cannula is placed inside a vein to provide venous access needed for dialysis. Dialysis infiltration is a problem that occurs when the needle inadvertently punctures through the vein after being inserted into the vein. For example, a nurse or technician may over-insert the needle and puncture both sides of a vein (e.g., “blow” a vein). One estimate states these dialysis infiltrations occur at an annual rate of 5.2% for patients with AV fistula access sites.

[0004] Infiltration causes pain, swelling and bruising and has significant physical and psychological impact on the patient. In addition, infiltration causes patients to miss lifesaving dialysis treatments and results in additional visits to the hospital. Infiltration also results in extra diagnostic tests, interventions, or procedures which results in additional avoidable expenditure and cost to the patient. At the dialysis unit level, infiltration impacts staffing, nurse allocation, increases labor and consumable costs and overall resource utilization.

[0005] Conventional dialysis needles have features that focus on protecting the technician, with locking or anti-stick features to avoid accidental technician needle sticks.

[0006] Infiltration or injury also occurs during peripheral conventional intravenous needle placement. Studies report that the incidence of infiltration ranges from 10% to 30% in adult patients, and rates as high as 33% to 50% in pediatric patients. Effects of infiltration can vary and can range from swelling to blisters, severe tissue injury, or even necrosis of tissues. Theseevents result in significant complications, delays in receiving IV medications, morbidity, and need for procedural interventions.SUMMARY

[0007] The Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

[0008] One aspect of the present disclosure provides a device including a housing having a first chamber and a second chamber, a needle with a first lumen and a first needle end, and a blunt member with a second lumen. The blunt member is movable with respect to the needle and is at least partially positioned within the first lumen. The device further includes a piston movable within the first chamber. The blunt member is coupled to the piston for movement with the piston. The device is movable between a first configuration and a second configuration. In the first configuration, the blunt member is spaced from the first needle end and the second lumen is not in fluid communication with the second chamber. In the second configuration, the blunt member extends from the needle and the second lumen is in fluid communication with the second chamber. The device moves from the first configuration to the second configuration in response to a pressure in the second lumen.

[0009] In some embodiments, the pressure in the second lumen is in response to the first needle end being placed in fluid communication with a fluid.

[0010] In some embodiments, the piston is positioned closer to the first needle end in the second configuration than in the first configuration.

[0011] In some embodiments, the housing includes a passageway extending between the first chamber and the second chamber.

[0012] In some embodiments, the first chamber defines a first chamber axis and the second chamber defines a second chamber axis, and wherein the first chamber axis is spaced from and parallel to the second chamber axis.

[0013] In some embodiments, the first chamber defines a first chamber axis and the second chamber defines a second chamber axis, and wherein the first chamber axis intersects the secondchamber axis at an angle. In some embodiments, the angle is within a range of 15 degrees to 90 degrees.

[0014] In some embodiments, the needle includes a second needle end opposite the first needle end, and wherein the second needle end is positioned within an aperture formed in the housing.

[0015] In some embodiments, the first lumen defines a first lumen axis and the second lumen defines a second lumen axis, and wherein the first lumen axis is co-axial with the second lumen axis.

[0016] In some embodiments, the first chamber defines a first chamber axis that is co-axial with the first lumen axis and co-axial with the second lumen axis.

[0017] In some embodiments, the device further includes an O-ring positioned within a groove formed in the piston.

[0018] In some embodiments, the O-ring slides along a side wall of the first chamber.

[0019] In some embodiments, the second lumen is in fluid communication with the first chamber in the first configuration and in the second configuration.

[0020] In some embodiments, the blunt member extends through an aperture formed in the piston.

[0021] In some embodiments, the device further includes a first cap coupled to the housing, wherein the first cap at least partially defines the first chamber.

[0022] In some embodiments, the first cap is movable with respect to the housing such that movement of the first cap adjusts a size of the first chamber.

[0023] In some embodiments, the device further includes a second cap coupled to the housing, wherein the second cap includes an aperture in fluid communication with the second chamber.

[0024] In some embodiments, when the device is in the first configuration, the piston is positioned at a first end of the first chamber, and when the device is in the second configuration, the piston is positioned at a second end of the first chamber, opposite the first end.

[0025] In some embodiments, when the device is in the second configuration, the first needle end is entirely blocked by the blunt member.

[0026] In some embodiments, the device moves from the first configuration to the second configuration in response to the first needle end being inserted into a blood vessel of a subject.

[0027] In some embodiments, the housing is transparent or translucent.

[0028] In some embodiments, the device further comprises a locking assembly; wherein the locking assembly, upon the device entering the second configuration, inhibits the device from moving from the second configuration to the first configuration.

[0029] In some embodiments, the locking assembly includes a lock positioned on the blunt member and a corresponding aperture formed in the needle; and wherein the lock is at least partially received within the aperture when the device is in the second configuration.

[0030] In some embodiments, the blunt member includes a rib extending radially from an outer surface, and wherein the needle includes a channel; and wherein the rib is at least partially received within the channel.

[0031] In some embodiments, the lock is a deflectable wing; and in the first configuration the deflectable wing is biased into a deflected position within the first lumen.

[0032] In some embodiments, the needle includes a connecting portion that connects to the housing, and wherein the aperture is formed in the connecting portion of the needle.

[0033] In some embodiments, the locking assembly includes a lock positioned on the needle and a corresponding aperture formed in the blunt member; and wherein the lock is at least partially received within the aperture when the device is in the second configuration.

[0034] In some embodiments, the needle includes a connecting portion that connects to the housing, and wherein the lock is positioned on the connecting portion of the needle.

[0035] In some embodiments, the lock is a deflectable bridge with a finger; and in the first configuration, the deflectable bridge is biased into a deflected position by a sidewall of the blunt member.

[0036] In some embodiments, the lock is a deflectable arm, and in the first configuration, the deflectable arm is biased into a deflected position by a sidewall of the blunt member.

[0037] In some embodiments, the deflectable arm includes a spherical -shaped end or a triangular’- shaped end.

[0038] In some embodiments, the device further comprises a wing extending from the housing and an adhesive positioned on at least one side of the wing.

[0039] One aspect of the present disclosure provides a device including a housing having a first chamber and a second chamber; a needle with a first lumen and a first needle end; and a blunt member with a second lumen. The needle is at least partially positioned within the second lumen. The device further includes a piston movable within the first chamber. The device is movable between a first configuration and a second configuration. When the device is in the first configuration, the blunt member is spaced from the first needle end and the first lumen is not in fluid communication with the second chamber. When the device is in the second configuration, the blunt member extends from the needle and the first lumen is in fluid communication with the second chamber. The device moves from the first configuration to the second configuration in response to a pressure in the first lumen.

[0040] In some embodiments, the needle includes a second needle end opposite the first needle end, and wherein the second needle end is positioned within an aperture formed in the housing.

[0041] In some embodiments, the needle further includes an aperture formed in a sidewall.

[0042] In some embodiments, the first lumen defines a first lumen axis and the second lumen defines a second lumen axis, and wherein the first lumen axis is co-axial with the second lumen axis.

[0043] In some embodiments, when in the first configuration, the piston is positioned at a first end of the first chamber, and when in the second configuration, the piston is positioned at a second end of the first chamber, opposite the first end.

[0044] In some embodiments, when in the second configuration, the first needle end is entirely blocked by the blunt member.

[0045] In some embodiments, the device moves from the first configuration to the second configuration in response to the first needle end being inserted into a blood vessel of a subject.

[0046] In some embodiments, the needle includes a side hole in fluid communication with the first lumen.

[0047] Other aspects of the disclosure will become apparent by consideration of the detailed description and accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The accompanying figures and examples are provided by way of illustration and not by way of limitation. The foregoing aspects and other features of the disclosure are explained in the following description, taken in connection with the accompanying example figures (also “FIG.”) relating to one or more embodiments.

[0049] FIG. 1 is a perspective view of a needle device.

[0050] FIG. 2 is a cross-sectional view of the needle device of FIG. 1, shown in a first configuration with a blunt member retracted.

[0051] FIG. 3 is a cross-sectional view of the needle device of FIG. 1, shown in an intermediate configuration.

[0052] FIG. 4 is a cross-sectional view of the needle device of FIG. 1, shown in a second configuration with the blunt member extended.

[0053] FIG. 5A is a cross-sectional view of a needle device, shown in a first configuration with a blunt member retracted.

[0054] FIG. 5B is a cross-sectional view of the needle device of FIG. 5A, shown in a second configuration with the blunt member extended.

[0055] FIG. 6A is a cross-sectional view of a needle device, shown in a first configuration with a blunt member retracted.

[0056] FIG. 6B is a cross-sectional view of the needle device of FIG. 6A, shown in a second configuration with the blunt member extended.

[0057] FIG. 7A is a cross-sectional view of a needle device, shown in a first configuration with a blunt member retracted.

[0058] FIG. 7B is a cross-sectional view of the needle device of FIG.7A, shown in a second configuration with the blunt member extended.

[0059] FIG. 8A is a cross-sectional view of a needle device, shown in a first configuration with a blunt member retracted.

[0060] FIG. 8B is a cross-sectional view of the needle device of FIG. 8A, shown in a second configuration with the blunt member extended.

[0061] FIG. 9A is a cross-sectional view of a needle device, shown in a first configuration with a blunt member retracted.

[0062] FIG. 9B is a cross-sectional view of the needle device of FIG. 9A, shown in a second configuration with the blunt member extended.

[0063] FIG. 10A is a cross-sectional view of a needle device, shown in a first configuration with a blunt member retracted.

[0064] FIG. 10B is a cross-sectional view of the needle device of FIG. 10A, shown in a second configuration with the blunt member extended.

[0065] FIG. 11 is a partial tear-away view of a needle device.

[0066] Before any embodiments are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways.DETAILED DESCRIPTION

[0067] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing of the present disclosure. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety.The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

[0068] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to preferred embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended, such alteration and further modifications of the disclosure as illustrated herein, being contemplated as would normally occur to one skilled in the art to which the disclosure relates.

[0069] Articles “a” and “an” are used herein to refer to one or to more than one (i.e., at least one) of the grammatical object of the article. By way of example, “an element” means at least one element and can include more than one element.

[0070] ‘ ‘About” and “approximately” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “slightly above” or “slightly below” the endpoint without affecting the desired result.

[0071] The use herein of the terms "including," "comprising," or "having," and variations thereof, is meant to encompass the elements listed thereafter and equivalents thereof as well as additional elements. As used herein, “and / or” refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as the lack of combinations when interpreted in the alternative (“or”).

[0072] Moreover, the present disclosure also contemplates that in some embodiments, any feature or combination of features set forth herein can be excluded or omitted. To illustrate, if the specification states that an apparatus comprises components A, B, and C, it is specifically intended that any of A, B or C, or a combination thereof, can be omitted and disclaimed singularly or in any combination.

[0073] Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expresslyenumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this disclosure.

[0074] “Subject” and “patient” as used herein interchangeably refers to any vertebrate, including, but not limited to, a mammal (e.g., cow, pig, camel, llama, horse, goat, rabbit, sheep, hamsters, guinea pig, cat, dog, rat, and mouse, a non-human primate (e.g., a monkey, such as a cynomolgus or rhesus monkey, chimpanzee, etc.) and a human). In some embodiments, the subject may be a human or a non-human. In one embodiment, the subject is a human. The subject or patient may be undergoing various forms of treatment.

[0075] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0076] With reference to FIG. 1, a needle device 10 includes a housing 14, a needle 18, and a blunt member 22. As detailed further herein, in the illustrated embodiment, the blunt member 22 automatically moves in response to the needle 18 entering a blood vessel (e.g., vein, vasculature, fistula, etc.) of a patient to block the needle 18 from further puncturing the blood vessel. As such, the needle device 10 reduces the rate of costly complications such as thrombosis, stenosis, aneurysm, hemorrhage, and unnecessary procedures and interventions associated with infiltrations. The needle devices disclosed herein may be utilized for dialysis treatment, peripheral IV treatment, or any other type of treatment utilizing a needle.

[0077] With reference to FIG. 2, the housing 14 includes a first chamber 26 and a second chamber 30. The first chamber 26 defines a first chamber axis 34 and the second chamber 30 defines a second chamber axis 38. In the illustrated embodiment, the first chamber axis 34 intersects the second chamber axis 38 at an angle 42. In some embodiments, the angle 42 is within a range of approximately 15 degrees to approximately 90 degrees. In some embodiments, the angle 42 is within a range of approximately 35 degrees to approximately 55 degrees. In some embodiments, the housing 14 includes a passageway 46 extending between the first chamber 26 and the second chamber 30. In some embodiments, the housing 14 is transparent or translucent such that a nurse or technician can visualize fluid within the housing 14.

[0078] With continued reference to FIG. 2, the needle 18 includes a first needle end 50 and a second needle end 54, opposite the first needle end 50. In the illustrated embodiment, the firstneedle end 50 includes a sharp bevel. In the illustrated embodiment, the second needle end 54 is positioned within an aperture 58 formed in the housing 14. The needle 18 includes a first lumen 62 extending between the first needle end 50 and the second needle end 54. The first lumen 62 defines a first lumen axis 66.

[0079] With continued reference to FIG. 2, the blunt member 22 includes a first blunt end 70 and a second blunt end 74, opposite the first blunt end 70. The blunt member 22 includes a second lumen 78 extending between the first blunt end 70 and the second blunt end 74. In other words, the blunt member 22 is hollow. The second lumen 78 defines a second lumen axis 82. In the illustrated embodiment, the first lumen axis 66 is co-axial with the second lumen axis 82. In the illustrated embodiment, the first chamber axis 34 is co-axial with the first lumen axis 66 and co-axial with the second lumen axis 82. In the illustrated embodiment, the blunt member 22 is movable with respect to the needle 18 and is at least partially positioned within the first lumen 62. In other words, the needle 18 is positioned radially outward of the blunt member 22.

[0080] With continued reference to FIG. 2, the device 10 includes a piston 86 movable within the first chamber 26 along the first chamber axis 34. In the illustrated embodiment, the blunt member 22 is coupled to the piston 86 for movement with the piston 86. In other words, the blunt member 22 translates with the piston 86 as the piston 86 moves along the first chamber axis 34 of the first chamber 26. In the illustrated embodiment, the blunt member 22 extends through an aperture 90 formed in the piston 86. As such, the second lumen 78 of the blunt member 22 is in fluid communication with the first chamber 26.

[0081] The device 10 further includes an O-ring 94 positioned within a groove 98 formed in the piston 86. The O-ring 94 seals one side of the piston 86 from the opposite side of the piston 86. In the illustrated embodiment, the O-ring 94 slides along a cylindrical sidewall 102 of the first chamber 26. In the illustrated embodiment, the O-ring 94 seals one portion of the first chamber 26 from another portion of the first chamber 26.

[0082] The device 10 further includes a first cap 106 coupled to the housing 14 and a second cap 110 coupled to the housing 14. The first cap 106 at least partially defines the first chamber 26. In the illustrated embodiment, a surface 114 of the first cap 106 at least partially defines the first chamber 26. In the illustrated embodiment, the surface 114 is positioned opposite from and in facing relationship with the second blunt end 74 of the blunt member 22. In someembodiments, the first cap 106 is movable with respect to the housing 14 such that movement of the first cap 106 adjusts a size of the first chamber 26. In the illustrated embodiment, the first cap 106 and the housing 14 form a threaded connection. The second cap 110 includes an aperture 118 in fluid communication with the second chamber 30. In some embodiments, the aperture 118 is connected to tubing, sample collection, etc. In the illustrated embodiment, the second cap 110 and the housing 14 form a threaded connection.

[0083] In some embodiments, a hydrophobic vent is coupled to the second chamber 30 that allows air to escape but blood to stay in. Venting provides for flash (e.g., visualization of blood return after venipuncture). In some embodiments, the vent is positioned with the aperture 118 of the second cap 1 10. In some embodiments, the second chamber 30 is connected to tubing via a removable vented cap. In some embodiments, the tubing includes a clamp to prevent blood loss when removing the cap to connect to a dialysis machine, for example. In other embodiments, manual occlusion is provided by the clinician. In some embodiments, the second cap 110 is removeable to attach to the dialysis machine. In some embodiments the first chamber 26 is sealed. In one embodiment, tubing is attached to the first chamber 26. In some embodiments, tubing is permanently attached to the first chamber, without a venting cap. In some embodiments, tubing could be attached after removal of the first cap 106. In some embodiments, the first cap 106 is a self-sealing injection site that tubing can puncture to create a fluid path.

[0084] In some embodiments, the device includes at least one anti-stick feature that prevents the device from being reused. For example, when the device moves to the second configuration, the blunt member and the piston are locked in position and the device is not able to move back to the first configuration. In some embodiments, the device includes a lock or detent that engages the piston when the piston moves to the second configuration.

[0085] In operation, the device 10 is movable between a first configuration (e.g., FIG. 2) with the blunt member 22 retracted within the needle 18, and a second configuration (e.g., FIG. 4) with the blunt member 22 extending from the needle 18. As detailed herein, the device 10 moves from the first configuration to the second configuration in response to a pressure in the second lumen 78. In some cases, the pressure in the second lumen 78 is in response to the first needle end 50 being placed in fluid communication with a fluid (e.g., blood in a blood vessel). In other words, pressure from a blood vessel builds in the second lumen 78 and the first chamber26 to move the piston 86 within the first chamber 26. The piston 86 is positioned closer to the first needle end 54 in the second configuration than in the first configuration. In other words, the piston 86 moves right to left along the first chamber axis 34 as viewed from FIG. 2, in response to the needle 18 entering a blood vessel.

[0086] With reference to FIG. 2, in the first configuration, the blunt member 22 is spaced from the first needle end 50, and the piston 86 is positioned at a first end 122 of the first chamber 26. In other words, the blunt member 22 is retracted within the needle 18 and the first needle end 50 is exposed and configured for piercing. In the first configuration, the second lumen 78 is in fluid communication with the first chamber 26, but the second lumen 78 is not in fluid communication with the second chamber 30 because the O-ring 94 is blocking the passageway 46.

[0087] With reference to FIG. 3, in an intermediate configuration, the device 10 moves from the first configuration to the second configuration in response to a pressure present in the second lumen 78. In the illustrated embodiment, the device 10 moves from the first configuration to the second configuration in response to the first needle end 50 being inserted into a blood vessel 130 of a subject 134. In other words, the pressure in the second lumen 78 is in response to the needle 18 entering the blood vessel 130. Blood flows through the second lumen 78 and into the first chamber 26 (indicated by arrows 138 of FIG. 3), where the increase in pressure translates the piston 86 along the first cavity axis 34.

[0088] With reference to FIG. 4, in a second configuration, the blunt member 22 extends from the needle 18, thereby preventing the needle 18 from further piercing through the blood vessel 130. In other words, the blunt member 22 at least partially blocks the first needle end 50 in the second configuration. In some embodiments, the first needle end 50 is entirely blocked by the blunt member 22 in the second configuration. In some embodiments, the blunt member 22 extends at least approximately 4 mm past the first needle end 50. In the second configuration, the piston 86 is positioned at a second end 126 of the first chamber 26, opposite the first end 122. In the illustrated embodiment, the O-ring 94 is positioned past the passageway 46 such that fluid entering the first chamber 26 from the second lumen 78 may flow through the passageway 46 to the second chamber 30 (indicated by arrows 142 of FIG. 4). As such, the second lumen 78 is influid communication with the first chamber 26 and the second chamber 30 when the device 10 is in the second configuration.

[0089] In one embodiment, the sharp outer needle 18 penetrates the patient’ s skin and establishes access to the blood vessel 130. Pressure from the blood flow entering the first chamber 26 causes movement of the piston 86 and the blunt member 22. With the blunt member 22 extended, the technician or nurse is less likely to puncture through the back wall of the blood vessel 130, causing an infiltration.

[0090] Advantageously, the needle devices disclosed herein reduced infiltrations, aids proper position, optimizes blood flow, and protects the safety of the technician or nurse. The needle devices disclosed herein helps a technician or nurse successfully and safely cannulate a dialysis patient. In some embodiments, the device provides vascular access to an AV fistula for hemodialysis; vascular access to AV graft for hemodialysis; vascular access for IV catheter insertion; vascular access for vascular catheter insertion; or any combination thereof.

[0091] In some embodiments, the needle and the blunt member positions are swapped such that the needle is positioned inside the blunt member. In some embodiments, the movable piston is coupled to the needle and the blunt member is fixedly attached to the housing. In one alternative, the needle automatically retracts in response to pressure (e.g., from a blood vessel) thereby exposing the fixed blunt member.

[0092] With reference to FIGS. 5A and 5B, a needle device 510 includes a housing 514, a needle 518, and a blunt member 522. As detailed further herein, in the illustrated embodiment, the blunt member 522 automatically moves in response to the needle 518 entering a blood vessel (e.g., vein, vasculature, fistula, etc.) of a patient to block the needle 518 from further puncturing the blood vessel. The housing 514 includes a first chamber 526 and a second chamber 530. The first chamber 526 defines a first chamber axis 534 and the second chamber 530 defines a second chamber axis 538. In the illustrated embodiment, the first chamber axis 534 is spaced from and parallel to the second chamber axis 538. In the illustrated embodiment, the housing 514 includes a passageway 542 extending between the first chamber 526 and the second chamber 530.

[0093] The needle 518 includes a first needle end 546 and a second needle end 550, opposite the first needle end 546. The needle 518 includes a first lumen 554 extending between the firstneedle end 546 and the second needle end 550. The first lumen 554 defines a first lumen axis 558.

[0094] With continued reference to FIGS. 5 A and 5B, the blunt member 522 includes a first blunt end 562 and a second blunt end 566, opposite the first blunt end 562. The blunt member 522 includes a second lumen 570 extending between the first blunt end 562 and the second blunt end 566. In other words, the blunt member 522 is hollow. The second lumen 570 defines a second lumen axis 574. In the illustrated embodiment, the first lumen axis 558 is co-axial with the second lumen axis 574. In the illustrated embodiment, the blunt member 522 is movable with respect to the needle 518 and is at least partially positioned within the first lumen 554. The device 510 includes a piston 578 movable within the first chamber 526. In the illustrated embodiment, the blunt member 522 is coupled to the piston 578 for movement with the piston 578.

[0095] The device 510 is movable between a first configuration (FIG. 5 A) and a second configuration (FIG. 5B). With reference to FIG. 5A, when the device 510 is in the first configuration, the blunt member 522 is spaced from the first needle end 546 and the second lumen 570 is not in fluid communication with the second chamber 530. With reference to FIG. 5B, when the device 510 is in the second configuration, the blunt member 522 extends from the needle 518 and the second lumen 570 is in fluid communication with the second chamber 530. The device 510 moves from the first configuration to the second configuration in response to a pressure in the second lumen 570. In some embodiments, the device 510 moves between configurations in response to a pressure in a subject vein, for example, as low as approximately 2.9 kPa.

[0096] With continued reference to FIGS. 5A and 5B, the device 510 includes a locking assembly 580. Upon the device 510 entering the second configuration, the locking assembly 580 inhibits the device 510 from moving from the second configuration to the first configuration. In other words, once the blunt member 522 is extended, the locking assembly 580 holds the blunt member 522 in the extended position and prevents retraction of the blunt member 522. In the illustrated embodiment, the locking assembly 580 includes at least one lock 582 positioned on the blunt member 522 and at least one corresponding aperture 584 formed in the needle 518. In the illustrated embodiment, the apertures 584 are non-orthogonal with respect to the first lumenaxis 558. Each lock 582 is at least partially received within the corresponding aperture 584 when the device 510 is in the second configuration (FIG. 5B).

[0097] In the illustrated embodiment, the lock 582 is a deflectable wing 586. In the first configuration the deflectable wing 586 is biased into a deflected position within the first lumen 554. In other words, the deflectable wing 586 is held in a deflected position by the needle 518 until the deflectable wing 586 aligns with the aperture 584 and is then free to return to an unbiased position that extends radially outward. Once the deflectable wing 586 is at least partially received within the aperture 584, the deflectable wing 586 inhibits subsequent retraction of the blunt member 522. In the illustrated embodiment, the blunt member 522 includes a plurality of ribs 588 extending radially from an outer cylindrical surface 590, and the needle 518 includes a corresponding plurality of channels 592 formed in an inner cylindrical surface 594. Each rib 588 is at least partially received within a corresponding channel 592, which advantageously maintains the alignment of the locks 582 and the apertures 584. In other words, the ribs 588 and the channels 592 prevent relative rotation between the blunt member 522 and the needle 518. In some embodiments, at least a portion of the locking assembly 580 is additively manufactured (e.g., 3D printed).

[0098] With reference to FIGS. 6A and 6B, a needle device 610 includes a housing 614 having a first chamber 618 and a second chamber 622, a needle 626, and a blunt member 630. The needle 626 includes a first lumen 634 and a first needle end 638. The blunt member 630 includes a second lumen 642. The blunt member 630 is movable with respect to the needle 626 and is at least partially positioned within the first lumen 634. The device 610 includes a piston 646 movable within the first chamber 618, and the blunt member 630 is coupled to the piston 646 for movement with the piston 646.

[0099] The device 610 is movable between a first configuration (FIG. 6A) and a second configuration (FIG. 6B). With reference to FIG. 6A, when the device 610 is in the first configuration, the blunt member 630 is spaced from the first needle end 638 and the second lumen 642 is not in fluid communication with the second chamber 622. With reference to FIG. 6B, when the device 610 is in the second configuration, the blunt member 630 extends from the needle 626 and the second lumen 642 is in fluid communication with the second chamber 622.The device 610 moves from the first configuration to the second configuration in response to a pressure in the second lumen 642.

[0100] With continued reference to FIGS. 6 A and 6B, the device 610 includes a locking assembly 650. Upon the device 610 entering the second configuration, the locking assembly 650 inhibits the device 610 from moving from the second configuration to the first configuration. In the illustrated embodiment, the locking assembly 650 includes a lock 654 positioned on the needle 626 and a corresponding aperture 658 formed in the blunt member 630. The locking assembly 650 may include any number of locks and corresponding apertures. The lock 654 is at least partially received within the aperture 658 when the device 610 is in the second configuration. In the illustrated embodiment, the needle 626 includes a connecting portion 662 that connects to the housing 614, and wherein the lock 654 is positioned on the connecting portion 662 of the needle 626. In some embodiments, the connecting portion 662 is formed as a separate and removable portion of the needle 626. In other embodiments, the connecting portion 662 is integral with the remaining portions of the needle 626. In the illustrated embodiment, the lock 654 is a deflectable bridge 666 with a finger 670 extending radially inward from the deflectable bridge 666. In the first configuration, the deflectable bridge 666 is biased into a deflected position by a sidewall 674 of the blunt member 630. A portion of the finger 670 extends through an aperture 678 formed on the connecting portion 662. The deflectable bridge 666 returns to an unbiased position once the aperture 658 on the needle 626 aligns with the finger 670. In some embodiments, the deflectable bridge 666 creates a seal in the second configuration to prevent any leakage through the aperture 678. In the illustrated embodiment, a plurality of ribs 680 and a corresponding plurality of channels 682 prevent relative rotation between the needle 626 and the blunt member 630. In the illustrated embodiment, the plurality of channels 682 are formed on the connecting portion 662 of the needle 626.

[0101] With reference to FIGS. 7A and 7B, a needle device 710 includes a housing 714 having a first chamber 718 and a second chamber 722, a needle 726, and a blunt member 730. The needle 726 includes a first lumen 734 and a first needle end 738. The blunt member 730 includes a second lumen 742. The blunt member 730 is movable with respect to the needle 726 and is at least partially positioned within the first lumen 734. The device 710 includes a piston 746 movable within the first chamber 718, and the blunt member 730 is coupled to the piston 746 for movement with the piston 746.

[0102] The device 710 is movable between a first configuration (FIG. 7A) and a second configuration (FIG. 7B). With reference to FIG. 7A, when the device 710 is in the first configuration, the blunt member 730 is spaced from the first needle end 738 and the second lumen 742 is not in fluid communication with the second chamber 722. With reference to FIG. 7B, when the device 710 is in the second configuration, the blunt member 730 extends from the needle 726 and the second lumen 742 is in fluid communication with the second chamber 722. The device 710 moves from the first configuration to the second configuration in response to a pressure in the second lumen 742.

[0103] With continued reference to FIGS. 7A and 7B, the device 710 includes a locking assembly 750. Upon the device 710 entering the second configuration, the locking assembly 750 inhibits the device 710 from moving from the second configuration to the first configuration. In the illustrated embodiment, the locking assembly 750 includes a lock 754 positioned on the needle 726 and a corresponding aperture 758 formed in the blunt member 730. The lock 754 is at least partially received within the aperture 758 when the device 510 is in the second configuration. In the illustrated embodiment, the needle 726 includes a connecting portion 762 that connects to the housing 714, and the lock 754 is positioned on the connecting portion 762 of the needle 726. In the illustrated embodiment, the lock 754 is a deflectable arm 766 attached at one end to the connecting portion 762. The deflectable arm 766 includes a spherical-shaped end 770 that is configured to be received within the aperture 758. In the first configuration, the deflectable arm 766 is biased into a deflected position by a sidewall 774 of the blunt member 730. The deflectable arm 766 returns to an unbiased position once the aperture 758 aligns with the spherical- shaped end 770 of the deflectable arm 766. In the illustrated embodiment, a plurality of ribs 780 and a corresponding plurality of channels 782 prevent relative rotation between the needle 726 and the blunt member 730.

[0104] With reference to FIGS. 8A and 8B, a needle device 810 is shown similar to the needle device 710 of FIGS. 7A and 7B, with only the differences discussed herein. The same reference numerals used in FIGS. 7A and 7B are used to refer to the same features in FIGS. 8A and 8B, as appropriate. In the illustrated embodiment, the needle device 810 includes a lock 812 that is a deflectable arm 814 attached at one end to the connecting portion 762. The deflectable arm 814 includes a triangular-shaped end 816. In the first configuration, the deflectable arm 814 is biased into a deflected position by the blunt member 730. The deflectable arm 814 returns to anunbiased position once the aperture 758 aligns with the triangular shaped end 816 of the deflectable arm 814.

[0105] With reference to FIGS. 9A and 9B, a needle device 910 includes a housing 914 having a first chamber 918 and a second chamber 922, a needle 926, and a blunt member 930. The needle 926 includes a first lumen 934 and a first needle end 938. The blunt member 930 includes a second lumen 942. The blunt member 930 is movable with respect to the needle 926 and is at least partially positioned within the first lumen 934. The device 910 includes a piston 946 movable within the first chamber 918, and the blunt member 930 is coupled to the piston 946 for movement with the piston 946.

[0106] The device 910 is movable between a first configuration (FIG. 9A) and a second configuration (FIG. 9B). With reference to FIG. 9A, when the device 910 is in the first configuration, the blunt member 930 is spaced from the first needle end 938 and the second lumen 942 is not in fluid communication with the second chamber 922. With reference to FIG. 9B, when the device 910 is in the second configuration, the blunt member 930 extends from the needle 926 and the second lumen 942 is in fluid communication with the second chamber 922. The device 910 moves from the first configuration to the second configuration in response to a pressure in the second lumen 942.

[0107] With continued reference to FIGS. 9 A and 9B, the device 910 includes a locking assembly 950. Upon the device 910 entering the second configuration, the locking assembly 950 inhibits the device 910 from moving from the second configuration to the first configuration. In the illustrated embodiment, the locking assembly 950 includes at least one lock 954 positioned on the blunt member 930 and at least one corresponding aperture 958 formed in the needle 926. In the illustrated embodiment, the needle 926 includes a connecting portion 962 that connects to the housing 914, and the aperture 958 is formed in the connecting portion 962 of the needle 926. Each lock 954 is at least partially received within the corresponding aperture 958 when the device 910 is in the second configuration (FIG. 9B). In the illustrated embodiment, the lock 954 is a deflectable wing 966. In the first configuration the deflectable wing 966 is biased into a deflected position within the first lumen 934. In other words, the deflectable wing 966 is held in a deflected position by the needle 926 until the deflectable wing 966 aligns with the aperture 958 at which point the deflectable wing 966 is free to return to an unbiased position that extendsradially outward. Once the deflectable wing 966 is at least partially received within the aperture 958, the deflectable wing 966 inhibits subsequent retraction of the blunt member 930. In the illustrated embodiment, a plurality of ribs 980 and a corresponding plurality of channels 982 prevent relative rotation between the needle 926 and the blunt member 930.

[0108] With reference to FIGS. 10A and 10B, a needle device 1010 includes a housing 1014 having a first chamber 1018 and a second chamber 1022, a needle 1026, and a blunt member 1030. The needle 1026 includes a first lumen 1034 and a first needle end 1038. The needle 1026 includes a second needle end 1042 opposite the first needle end 1038, and wherein the second needle end 1042 is positioned within an aperture 1046 formed in the housing 1014. In the illustrated embodiment, the aperture 1046 is formed in a first end 1050 of the first chamber 1018 such that the needle 1026 extends through the entire length of the first chamber 1018. In the illustrated embodiment, the needle 1026 further includes radial apertures 1054 formed in a sidewall 1058 that fluidly communicate the first lumen 1034 with the first chamber 1018. In some embodiments, the needle 1026 includes a side hole (also referred to as a side port) in fluid communication with the first lumen 1034. The side hole advantageously allows for the passage of blood, which improves flow and reduced the risk of clogging or damage to blood cells.

[0109] The blunt member 1030 includes a second lumen 1062. The first lumen 1034 defines a first lumen axis 1066 and the second lumen 1062 defines a second lumen axis 1070. In the illustrated embodiment, the first lumen axis 1066 is co-axial with the second lumen axis 1070. In the illustrated embodiment, the needle 1026 is at least partially positioned within the second lumen 1062. In other words, the needle 1026 is positioned radially within the blunt member 1030. The device 1010 includes a piston 1074 movable within the first chamber 1018.

[0110] The device 1010 is movable between a first configuration (FIG. 10A) and a second configuration (FIG. 10B). With reference to FIG. 10A, when the device 1010 is in the first configuration, the blunt member 1030 is spaced from the first needle end 1038 and the first lumen 1034 is not in fluid communication with the second chamber 1022. With reference to FIG. 10B, when the device 1010 is in the second configuration, the blunt member 1030 extends from the needle 1026 and the first lumen 1034 is in fluid communication with the second chamber 1022. When in the second configuration, the first needle end 1038 is entirely blocked by the blunt member 1030.

[0111] The device 1010 moves from the first configuration to the second configuration in response to a pressure in the first lumen 1034. When in the first configuration, the piston 1074 is positioned at the first end 1050 of the first chamber 1018, and when in the second configuration, the piston 1074 is positioned at a second end 1078 of the first chamber 1018, opposite the first end 1050. As detailed herein, the device 1010 moves from the first configuration to the second configuration in response to the first needle end 1038 being inserted into a blood vessel of a subject. The needle 1026 is then blunted by the blunt member 1030 in the second configuration to prevent infiltration or accidental sticks.

[0112] With reference to FIG. 11, a needle device 1110 includes at least one wing 1114 extending from a housing 1 118. The wings 1114 may be referred to as “butterfly wings.” The wings 1114 advantageously provide improve handling and securement. In some embodiments, an adhesive 1122 is positioned on at least one side (e.g., a bottom side or a top side) of the wing 1114. In some embodiments, the adhesive 1122 is a double-sided tape, with one side adhering to the patient’s skin and the other side adhering to the wing 1114. Needle devices disclosed herein advantageously prevent needle infiltration, needle stick injury, and needle dislodgment.

[0113] One skilled in the art will readily appreciate that the present disclosure is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent herein. The present disclosure described herein are exemplary embodiments and are not intended as limitations on the scope of the present disclosure. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the present disclosure as defined by the scope of the claims.

[0114] No admission is made that any reference, including any non-patent or patent document cited in this specification, constitutes prior art. In particular, it will be understood that, unless otherwise stated, reference to any document herein does not constitute an admission that any of these documents forms part of the common general knowledge in the art in the United States or in any other country. Any discussion of the references states what their authors assert, and the applicant reserves the right to challenge the accuracy and pertinence of any of the documents cited herein. All references cited herein are fully incorporated by reference, unless explicitly indicated otherwise. The present disclosure shall control in the event there are any disparities between any definitions and / or description found in the cited references.

[0115] Various features and advantages are set forth in the following claims.

Claims

CLAIMSWhat is claimed is:

1. A device comprising: a housing having a first chamber and a second chamber; a needle with a first lumen and a first needle end; a blunt member with a second lumen; the blunt member is movable with respect to the needle and is at least partially positioned within the first lumen; and a piston movable within the first chamber; wherein the blunt member is coupled to the piston for movement with the piston; wherein the device is movable between a first configuration and a second configuration, when in the first configuration, the blunt member is spaced from the first needle end and the second lumen is not in fluid communication with the second chamber; and when in the second configuration, the blunt member extends from the needle and the second lumen is in fluid communication with the second chamber; wherein the device moves from the first configuration to the second configuration in response to a pressure in the second lumen.

2. The device of claim 1, wherein the pressure in the second lumen is in response to the first needle end being placed in fluid communication with a fluid.

3. The device of claim 1, wherein the piston is positioned closer to the first needle end in the second configuration than in the first configuration.

4. The device of claim 1, wherein the housing includes a passageway extending between the first chamber and the second chamber.

5. The device of claim 1 , wherein the first chamber defines a first chamber axis and the second chamber defines a second chamber axis, and wherein the first chamber axis is spaced from and parallel to the second chamber axis.

6. The device of claim 1, wherein the first chamber defines a first chamber axis and the second chamber defines a second chamber axis, and wherein the first chamber axis intersects the second chamber axis at an angle, wherein the angle is within a range of 15 degrees to 90 degrees.

7. The device of claim 1, wherein the needle includes a second needle end opposite the first needle end, and wherein the second needle end is positioned within an aperture formed in the housing.

8. The device of claim 1, wherein the first lumen defines a first lumen axis and the second lumen defines a second lumen axis, and wherein the first lumen axis is co-axial with the second lumen axis.

9. The device of claim 8, wherein the first chamber defines a first chamber axis that is coaxial with the first lumen axis and co-axial with the second lumen axis.

10. The device of claim 1, further including an O-ring positioned within a groove formed in the piston.

11. The device of claim 10, wherein the O-ring slides along a sidewall of the first chamber.

12. The device of claim 1, wherein the second lumen is in fluid communication with the first chamber in the first configuration and in the second configuration.

13. The device of claim 1 , wherein the blunt member extends through an aperture formed in the piston.

14. The device of claim 1, further comprising a first cap coupled to the housing, wherein the first cap at least partially defines the first chamber.

15. The device of claim 14, wherein the first cap is movable with respect to the housing such that movement of the first cap adjusts a size of the first chamber.

16. The device of claim 14, further comprising a second cap coupled to the housing, wherein the second cap includes an aperture in fluid communication with the second chamber.

17. The device of claim 1, when in the first configuration, the piston is positioned at a first end of the first chamber, and when in the second configuration, the piston is positioned at a second end of the first chamber, opposite the first end.

18. The device of claim 1, when in the second configuration, the first needle end is entirely blocked by the blunt member.

19. The device of claim 1, wherein the device moves from the first configuration to the second configuration in response to the first needle end being inserted into a blood vessel of a subject.

20. The device of claim 1, wherein the housing is transparent or translucent.21 . The device of claim 1 , further comprising a locking assembly; wherein the locking assembly, upon the device entering the second configuration, inhibits the device from moving from the second configuration to the first configuration.

22. The device of claim 21, wherein the locking assembly includes a lock positioned on the blunt member and a corresponding aperture formed in the needle; and wherein the lock is at least partially received within the aperture when the device is in the second configuration.

23. The device of claim 22, wherein the blunt member includes a rib extending radially from an outer surface, and wherein the needle includes a channel; and wherein the rib is at least partially received within the channel.

24. The device of claim 22, wherein the lock is a deflectable wing; and in the first configuration the deflectable wing is biased into a deflected position within the first lumen.

25. The device of claim 22, wherein the needle includes a connecting portion that connects to the housing, and wherein the aperture is formed in the connecting portion of the needle.

26. The device of claim 21, wherein the locking assembly includes a lock positioned on the needle and a corresponding aperture formed in the blunt member; and wherein the lock is at least partially received within the aperture when the device is in the second configuration.

27. The device of claim 26, wherein the needle includes a connecting portion that connects to the housing, and wherein the lock is positioned on the connecting portion of the needle.

28. The device of claim 26, wherein the lock is a deflectable bridge with a finger; and in the first configuration, the deflectable bridge is biased into a deflected position by a sidewall of the blunt member.

29. The device of claim 25, wherein the lock is a deflectable arm, and in the first configuration, the deflectable arm is biased into a deflected position by a sidewall of the blunt member.

30. The device of claim 29, wherein the deflectable arm includes a spherical-shaped end or a triangular-shaped end.

31. The device of claim 1 , further comprising a wing extending from the housing and an adhesive positioned on at least one side of the wing.

32. A device comprising: a housing having a first chamber and a second chamber; a needle with a first lumen and a first needle end; a blunt member with a second lumen; wherein the needle is at least partially positioned within the second lumen; and a piston movable within the first chamber; wherein the device is movable between a first configuration and a second configuration, when in the first configuration, the blunt member is spaced from the first needle end and the first lumen is not in fluid communication with the second chamber; and when in the second configuration, the blunt member extends from the needle and the first lumen is in fluid communication with the second chamber; wherein the device moves from the first configuration to the second configuration in response to a pressure in the first lumen.

33. The device of claim 32, wherein the needle includes a second needle end opposite the first needle end, and wherein the second needle end is positioned within an aperture formed in the housing.

34. The device of claim 33, wherein the needle further includes an aperture formed in a sidewall.

35. The device of claim 32, wherein the first lumen defines a first lumen axis and the second lumen defines a second lumen axis, and wherein the first lumen axis is co-axial with the second lumen axis.

36. The device of claim 32, when in the first configuration, the piston is positioned at a first end of the first chamber, and when in the second configuration, the piston is positioned at a second end of the first chamber, opposite the first end.

37. The device of claim 32, when in the second configuration, the first needle end is entirely blocked by the blunt member.

38. The device of claim 32, wherein the device moves from the first configuration to the second configuration in response to the first needle end being inserted into a blood vessel of a subject.

39. The device of claim 32, wherein the needle includes a side hole in fluid communication with the first lumen.

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