CATHETER ASSEMBLY SUPPORT DEVICE, SYSTEM AND METHOD

Abstract

A support device for supporting a catheter assembly may include a platform that may include a top surface and a bottom surface. The support device may include an extension element coupled to the top surface of the platform. The extension element may include a distal end that may include a first connector configured to couple to the catheter assembly and a proximal end that may include a second connector. The extension element may include a valve movable between a first position and a second position. In response to the valve moving to the first position, a fluid path extending through the cannula and the extension element may be open and straight. In response to the valve moving to the second position, the fluid path may be closed. The support device may include a cannula, and the cannula may be swaged into the extension element.

Description

[Background technology]

[0001] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient.

[0002] A common type of catheter is the over-the-needle peripheral intravenous catheter ("PIVC"). As the name suggests, an over-the-needle PIVC may be fitted over an introducer needle that has a sharp distal tip. The PIVC and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC, with the bevel of the needle pointing up, away from the patient's skin. The PIVC and introducer needle are generally inserted through the skin into the patient's vasculature at a shallow insertion angle.

[0003] To confirm proper placement of the introducer needle and / or PIVC within the vessel, clinicians will typically confirm the presence of a "flashback" of blood within the flashback chamber of the PIVC assembly. Once needle placement is confirmed, the clinician may temporarily block flow within the vasculature and remove the introducer needle, leaving the PIVC in place for subsequent blood withdrawal and / or infusion.

[0004] Positioning of the PIVC within the vasculature is essential for blood withdrawal and infusion, but can be difficult to maintain. Patients often desire or require a normal range of motion during PIVC insertion. External objects may also apply external forces to the PIVC, which may shift the location of the PIVC within the vasculature. In some instances, external forces may cause dynamic back and forth movement of the tip of the PIVC, or a static shift of the tip from its location within the vasculature.

[0005] The PIVC assembly may be coupled with an extension set, which allows for the connection of an infusion or blood removal device at a location remote from the PIVC insertion site. The extension set may reduce the risk of disturbing the insertion site or of the catheter becoming dislodged from the patient's vasculature, although the risk may still remain.

[0006] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where certain embodiments described herein may be practiced. Summary of the Invention

[0007] The present disclosure relates generally to support devices and associated systems and methods. In an embodiment, the present disclosure relates to a support device capable of supporting a catheter assembly. In an embodiment, the support device may include a platform that may include an upper surface and a bottom surface. In an embodiment, the bottom surface may be configured to contact the patient's skin and / or at least a portion of the upper surface may be configured to support the catheter assembly. In an embodiment, the support device may include an extension element that may be coupled to the upper surface of the platform. In an embodiment, the extension element may include a distal end and a proximal end. In an embodiment, the distal end may include a first connector configured to couple to the catheter assembly. In an embodiment, the proximal end of the extension element may include a second connector.

[0008] In an embodiment, the extension element may include a valve that may be disposed between a distal end of the extension element and a proximal end of the extension element. In an embodiment, the valve may be movable between a first position and a second position. In an embodiment, the support device may include a cannula, which may extend distally from the distal end of the extension element and may be secured within the extension element. In an embodiment, in response to the valve moving to the first position, a fluid pathway extending through the cannula and the extension element may be open and straight. In an embodiment, in response to the valve moving to the second position, the fluid pathway may be closed.

[0009] In some embodiments, the valve may include a socket and an arm. In some embodiments, the arm may include a distal end, a proximal end, and a lumen extending through the distal end of the arm and the proximal end of the arm. In some embodiments, the distal end of the arm may include a ball portion that may be configured to rotate within the socket. In some embodiments, the proximal end of the arm may include a second connector. In some embodiments, the ball portion may be generally spherical. In some embodiments, the distal end of the arm may include one or more flat surfaces.

[0010] In some embodiments, an exterior surface of the ball may include a protrusion and / or the socket may include a slot. In some embodiments, the slot may include a first end and a second end. In some embodiments, in response to the valve moving to the first position, the protrusion may be disposed at the first end of the slot. In some embodiments, in response to the valve moving to the second position, the protrusion may be disposed at the second end of the slot.

[0011] In some embodiments, the slot may include a neck that may include a narrowed diameter, in some embodiments, the protrusion may pass through the neck that may provide an audible and / or tactile indication in response to the valve moving from the second position to the first position and / or from the second position to the first position.

[0012] In some embodiments, the socket may include one or more protrusions that may contact an outer surface of the arm, hi some embodiments, the protrusions may be configured to provide resistance to moving the valve between the first and second positions.

[0013] In an embodiment, the cannula may include a distal end, a proximal end, and a lumen extending through the distal end of the cannula and the proximal end of the cannula. In an embodiment, the proximal end of the cannula may include a wedge. In an embodiment, the cannula may be swaged into the extension element. In an embodiment, the wedge may provide a fluid seal after the cannula is swaged into the pocket. In an embodiment, forming the wedge at the proximal end of the cannula may include deep drawing, stamping, coating, or three-dimensional printing. In an embodiment, an outer surface of the cannula between the distal end of the cannula and the proximal end of the cannula may include a protrusion, which may be configured to secure the cannula within the extension element or to secure the cannula within the catheter assembly.

[0014] In some embodiments, the distal end of the arm may include a generally cylindrical shape that may be configured to rotate within the socket. In some embodiments, the socket may be generally cylindrical. In some embodiments, the proximal end of the arm may include a second connector. In some embodiments, the valve may include a handle, and the handle may be disposed on an exterior surface of the valve. In some embodiments, in response to a predetermined amount of rotation of the handle, the valve may move between a first position and a second position.

[0015] In an embodiment, the platform of the support device may be wedge-shaped. In an embodiment, a portion of the top surface may include a groove configured to receive a catheter adapter of the catheter assembly. In an embodiment, the first connector may include a snap feature, which may include an arm. In an embodiment, the arm may include a protrusion configured to engage a groove of the catheter adapter in a snap fit.

[0016] In an embodiment, the method of securing the cannula may include providing a cannula. In an embodiment, the method of securing the cannula may include forming a wedge on a proximal end of the cannula. In an embodiment, the method of securing the cannula may include providing a medical device that may include a pocket configured to receive the proximal end of the cannula. In an embodiment, the medical device may include a support device. In an embodiment, the medical device may include a syringe. In an embodiment, the method of securing the cannula may include inserting a proximal end of the cannula into the pocket and swaging the proximal end of the cannula into the pocket. In an embodiment, the extension element may include a pocket, and the pocket may be disposed between a distal end of the extension element and a proximal end of the extension element.

[0017] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not intended to limit the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. It should also be understood that the embodiments may be combined or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless otherwise stated in the claims. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief description of the drawings]

[0018] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0019] [Figure 1A] 1 is a top perspective view of an exemplary support device showing an exemplary extension element and an exemplary valve, according to an embodiment. [Figure 1B] 1B is a side view of the support device of FIG. 1A showing an exemplary catheter assembly coupled to the support device, according to an embodiment. [Figure 1C] FIG. 1 is a top view of a support device and catheter assembly, according to an embodiment. [Figure 2A] 1B is a top perspective view of the support device of FIG. 1A according to one embodiment. [Figure 2B] 1B is a cross-sectional view of the support device of FIG. 1A showing a valve in an exemplary first position according to an embodiment. [Figure 2C] 1B is a cross-sectional view of the support device of FIG. 1A showing the valve in an exemplary second position, according to an embodiment. [Figure 3A] 1B is a top perspective view of the support device of FIG. 1A showing a valve in a first position and an exemplary alignment mechanism, according to an embodiment. [Figure 3B] 1B is another top perspective view of the support device of FIG. 1A showing the valve and alignment mechanism in a second position, according to an embodiment. [Figure 3C] 1B is another top perspective view of the support device of FIG. 1A showing an exemplary neck portion, according to an embodiment. [Figure 3D] 1B is a top perspective view of the proximal end of the support device of FIG. 1A showing an exemplary protrusion that may contact an outer surface of an exemplary arm of an extension element, according to an embodiment. [Figure 3E] 1B is a cross-sectional view of the support device of FIG. 1A showing another exemplary valve, according to an embodiment. [Figure 4A] 1B is a side view of the support device of FIG. 1A showing another exemplary valve, according to an embodiment. [Figure 4B] 4B is a cross-sectional view of the support device of FIG. 4A showing the other valve in a first position according to an embodiment. [Figure 4C] 4B is a cross-sectional view of the support device of FIG. 4A showing the other valve in a second position according to an embodiment. [Figure 4D] 4B is a side view of the support device of FIG. 4A showing an alignment mechanism according to one embodiment. [Diagram 5] 1B is a cross-sectional view of the support device of FIG. 1A showing an exemplary cannula and an exemplary pocket configured to receive the cannula, according to an embodiment. [Figure 6A] 6 is a side view of the cannula of FIG. 5 in accordance with an embodiment. [Figure 6B] 6 is a top perspective view of the cannula of FIG. 5 in accordance with an embodiment. [Figure 6C] 6 is a side perspective view of the cannula of FIG. 5, showing exemplary protrusions on an exterior surface of the cannula, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] 1A-1C, according to one embodiment, a support device 10 capable of supporting a catheter assembly 12 is shown. In one embodiment, the support device 10 may be coupled to a proximal end of the catheter assembly 12 and may support the catheter assembly 12 at an angle relative to the patient's skin.

[0021] In some embodiments, the catheter assembly 12 may include a catheter adapter 14 and a catheter 16. In some embodiments, the catheter 16 may be secured within the catheter adapter 14 or may extend distally from a distal end of the catheter adapter 14. In some embodiments, the catheter 16 may include a peripheral intravenous catheter ("PIVC"), a peripherally inserted central catheter ("PICC"), or a midline catheter. In some embodiments, the catheter assembly 12 may be integrated with an integral extension tube or may not be integrated with an extension tube.

[0022] In an embodiment, an introducer needle (not shown) and catheter 16 may be inserted into the patient's skin 20 at a shallow insertion angle relative to the skin 20 to position the catheter 16 within the patient's vasculature for infusion and / or blood withdrawal. In an embodiment, the insertion angle may be about 30° or less. In an embodiment, the introducer needle may be removed after confirming that the catheter 16 is within the vasculature. In an embodiment, after the introducer needle is removed, the catheter assembly 12 may be coupled to the support device 10. In an embodiment, the support device 10 may be coupled to the proximal end of the catheter adapter 14. In an embodiment, the support device 10 may be integrated with the proximal end of the catheter adapter 14 or may be monolithically formed as a single unit with the proximal end of the catheter adapter 14.

[0023] In some embodiments, the support device 10 may include a platform 22. In some embodiments, the platform 22 may include an upper surface 24 and a bottom surface 26. In some embodiments, the bottom surface 26 may be configured to contact the patient's skin 20 to support the catheter assembly 12. In some embodiments, the bottom surface 26 of the platform 22 may be substantially flat and may lie flat against the skin 20. In some embodiments, at least a portion of the upper surface 24 of the platform 22 may be inclined relative to the bottom surface 26 and / or the skin 20. In some embodiments, the platform 22 may be wedge-shaped. In some embodiments, a portion of the upper surface 24 may be configured to support the catheter adapter 14 at an angle equal to or less than the insertion angle of the catheter 16.

[0024] In one embodiment, a portion of the upper surface 24 of the platform 22 may support the catheter assembly 12 in a position in which the distal end or nose of the catheter adapter 14 is angled downward toward the patient's skin 20 and the proximal end of the catheter adapter 14 is angled upward away from the patient's skin 20, thereby facilitating insertion of instruments through the support device 10 and / or into the vasculature. In one embodiment, the instruments may include additional catheters for infusion or blood withdrawal, guidewires, probes with sensors, or light tubes for disinfection.

[0025] In an embodiment, the upper surface 24 may include a groove 28, which may be aligned with a longitudinal axis of the support device 10. In an embodiment, the catheter adapter 14 may be placed within the groove 28. In an embodiment, the thickness of the support device 10 at the proximal end of the groove 28 is greater than the thickness of the support device 10 at the distal end of the groove 28, such that the groove 28 may support the catheter adapter 14 at an angle for insertion of an introducer needle into the patient's vasculature.

[0026] In some embodiments, at least a portion of the support device 10 may be constructed from a rigid material. In some embodiments, at least a portion of the support device 10, such as the platform 22, may be constructed from a soft, flexible material that may conform to the patient's skin.

[0027] In some embodiments, the support device 10 may include an extension element 18 that may be coupled to the upper surface 24 of the platform 22. In some embodiments, the extension element 18 may be coupled to a proximal portion or end of the platform 22. In some embodiments, the extension element 18 may be monolithically formed as a single unit with the platform 22. In some embodiments, the extension element 18 may improve patient comfort and reduce the risk of disturbance at the insertion site of the catheter 16 by moving the connection site of an infusion or blood removal device away from the insertion site.

[0028] In an embodiment, the extension element 18 may include a distal end 23 that may include a first connector 30. In an embodiment, the first connector 30 may be configured to couple to the catheter assembly 12. In an embodiment, the support device 10 may be coupled to the catheter adapter 14 in a snap-fit ​​manner. In an embodiment, the first connector 30 may include a snap feature or another suitable coupling mechanism that couples the support device 10 to the proximal end of the catheter adapter 14. In an embodiment, the snap feature may include one or more arms 15, each of which may include a protrusion 17 configured to be disposed within a groove of the catheter adapter 14 when the support device 10 is coupled to the catheter adapter 14 in a snap-fit ​​manner.

[0029] In some embodiments, the extension element 18 may include a cannula 32 that may extend distally from the distal end 23 of the extension element 18. In some embodiments, the cannula 32 may be secured within the support device 10. In some embodiments, the cannula 32 may extend parallel to a portion of the upper surface 24 of the platform 22. In some embodiments, the cannula 32 may be axially aligned with the longitudinal axis or fluid path of the catheter assembly 12.

[0030] In some embodiments, the cannula 32 may include a blunt cannula that may be configured to extend through a proximal opening at the proximal end of the catheter adapter 14 and penetrate a blood control septum 34 disposed within the lumen of the catheter adapter 14. In some embodiments, the catheter adapter 14 may include a blood control septum 34, which may be multiple use or single use.

[0031] In some embodiments, the extension element 18 may include a proximal end 35, which may include a second connector 36. In some embodiments, the second connector 36 may include a luer adapter, such as a male or female luer adapter. In some embodiments, the second connector 36 may include a slip or thread luer adapter or another suitable connector.

[0032] In certain embodiments, the extension element 18 may include a valve 38 that may be disposed between the distal end 23 of the extension element 18 and the proximal end 35 of the extension element 18. In certain embodiments, the valve 38 may be movable between a first position and a second position. In certain embodiments, the valve 38 may provide a means for closing a fluid pathway 40 to the external environment, thereby preventing bacteria from entering the extension element 18.

[0033] 2A-2C, in an embodiment, the valve 38 may be movable between a first position, e.g., as shown in FIG. 2A-2B, and a second position, e.g., as shown in FIG. 2C. In an embodiment, in response to the valve 38 being in the first position, the fluid pathway 40 extending through the cannula 32 and the extension element 18 may be open and straight, thereby allowing for fluid flow and / or instrument access. In an embodiment, in response to the valve 38 being moved to the second position, the fluid pathway 40 may be closed.

[0034] In an embodiment, the valve 38 may include a socket 42 and an arm 44. In an embodiment, the arm 44 may include a distal end 45, a proximal end 47, and a lumen 49 extending through the distal end 45 of the arm 44 and the proximal end 47 of the arm 44. In an embodiment, the fluid pathway 40 may include the lumen 49. In an embodiment, the distal end 45 of the arm 44 may include a ball portion 46 that may include a generally spherical outer surface. In an embodiment, the ball portion 46 may be configured to rotate within the socket, and the socket 42 may include a generally spherical inner surface. In an embodiment, the proximal end 47 of the arm 44 may include the second connector 36.

[0035] In some embodiments, the ball 46 may rotate freely within the socket 42. In some embodiments, the ball 46 at the distal end of the arm 44 may fit within the socket 42 such that the arm 44 may move about many axes having one common center. In some embodiments, the socket 42 and the ball 46 may fit together to prevent or minimize leakage of fluid from the fluid passageway 40 through the valve 38.

[0036] In some embodiments, in response to the valve 38 being in the first position, the fluid pathway 40 may be generally straight or aligned with the longitudinal axis 51 of the support device 10. In these and other embodiments, the valve 38 may be open to allow fluid to pass through the valve 38 and the catheter adapter 14. In some embodiments, in response to the valve 38 being in the second position, the fluid pathway 40 may be closed to prevent fluid from passing through the valve 38. In some embodiments, the fluid pathway 40 may include features, such as a diameter change, a slope, a protrusion, or annular spacers, that may guide an instrument through the fluid pathway 40 and into the catheter adapter 14, reducing or eliminating any catches.

[0037] In certain embodiments, in response to the valve 38 being in the second position, the arm 44 may be angled relative to the longitudinal axis 51. For example, in response to the valve 38 being in the second position, the arm 44 may be angled between 0° and 90°, or between 30° and 60°, relative to the longitudinal axis 51.

[0038] 3A-3B, in some embodiments, the outer surface of the arm 44 may include a protrusion 48. In some embodiments, the ball portion 46 may include a protrusion 48. In some embodiments, the socket 42 may include a slot 50, which may include a first end and a second end. In some embodiments, in response to the valve 38 moving to a first position, the protrusion 48 may be disposed at a first end of the slot 50, as shown, for example, in FIG. 3A. In some embodiments, in response to the valve 38 moving to a second position, the protrusion 48 may be disposed at a second end of the slot 50, as shown, for example, in FIG. 3B. It will be appreciated that in some embodiments, the inner surface of the socket 42 may include the protrusion 48 and the outer surface of the arm 44 may include the slot 50.

[0039] In some embodiments, the protrusions 48 and the slots 50 may be visible to a clinician on the socket 42 of the valve 38. In some embodiments, the protrusions 48 and the slots 50 may not be visible to a clinician. In some embodiments, the slots 50 may include holes that may extend through the socket 42, as shown, for example, in FIGS. 3A-3B. In other embodiments, the slots 50 may include grooves or recesses that may not extend through the socket 42. In some embodiments, the slots 50 may be generally U-shaped or curved.

[0040] In some embodiments, the protrusion 48 and slot 50 may provide an alignment mechanism for the socket 42 and ball 46, thereby limiting the range of motion of the arm 44. In some embodiments, the protrusion 48 may be proximate to or in contact with a first end of the slot 50 when the valve 38 is in a first position. In some embodiments, the protrusion 48 may be proximate to or in contact with a second end of the slot 50 when the valve 38 is in a second position. Thus, in some embodiments, the protrusion 48 and slot 50 may limit the movement of the arm 44 away from the longitudinal axis 51 beyond the second position.

[0041] 3C, in an embodiment, the slot 50 may include a neck 52. In an embodiment, the neck 52 may include a narrowed diameter that may be formed by two protrusions facing each other on either side of the slot 50. In an embodiment, in response to the valve 38 moving to the first position and / or the second position, the protrusion 48 may pass the neck 52, thereby providing an audible and / or tactile indication. In an embodiment, the audible indication may include a clicking noise. In an embodiment, the audible and / or tactile indication may indicate to the clinician or patient that the valve 38 is in the first position and / or the second position.

[0042] 3D, in some embodiments, one or more bumps or protrusions 53 may be disposed between the socket 42 and the arm 44. In some embodiments, the socket 42 may include one or more bumps or protrusions 53 that may contact an outer surface of the arm 44. In some embodiments, the protrusions 53 may be configured to provide resistance in moving the valve 38 between the first and second positions, thereby preventing inadvertent movement of the valve 38. In some embodiments, a particular protrusion 53 may be disposed opposite another particular protrusion 53. In some embodiments, the arm 44 may include the protrusions 53.

[0043] 3E, in some embodiments, the distal end 45 of the arm 44 may include one or more flat surfaces 54. In some embodiments, the socket 42 may include one or more other flat surfaces 55 that may move relative to the flat surfaces 54 to move the valve 38 between the first and second positions. In some embodiments, the flat surfaces 54 of the arm 44 and the flat surfaces 55 of the socket 42 may contact one another to provide resistance to further movement.

[0044] In some embodiments, in response to the valve 38 being in a first position, a particular flat surface 54 may be aligned with the fluid path 40. In some embodiments, in response to the valve 38 being in a second position, a particular flat surface 54 may be misaligned with the fluid path 40, closing the valve 38. In some embodiments, the flat surface 54 of the ball portion 46 and / or the other flat surfaces 55 of the socket 42 may act as a series of discrete positions for the arm 44 and / or the valve 38. In some embodiments, the flat surface 54 and the other flat surfaces 55 may provide a finite number of positions for the arm 44.

[0045] In certain embodiments, the distal end 45 may include a handle 58 (see, e.g., FIG. 4A ), which may be disposed on an outer surface of the valve 38. In response to a predetermined amount of rotation of the handle 58, the valve 38 may move between a first position and a second position. In certain embodiments, the distal end 45 may include a position indicator (not shown) disposed on an outer surface of the distal end 45 that provides an indication of the position of the valve 38. In certain embodiments, the protrusion 48 and the position of the protrusion 48 within the slot 50 may provide an indication of the position of the valve 38.

[0046] 4A, in an embodiment, the extension element 18 may include a valve 56. In an embodiment, the valve 56 may include or correspond to the valve 38. In an embodiment, the distal end 45 of the arm 44 of the valve 56 may include a cylindrical portion 57 as opposed to a ball portion 46. In an embodiment, in response to rotation of the cylindrical portion 57 within the socket 42, the valve 56 may move between a first position and a second position, which may include or correspond to the first and second positions of the valve 38, respectively. In an embodiment, the inner surface of the socket 42 may be generally cylindrical and may contact the cylindrical portion 57 to prevent leakage.

[0047] 4B-4D , in some embodiments, the cylindrical portion 57 may include a protrusion 48. In some embodiments, the socket 42 may include a slot 50. In response to the valve 56 moving to a first position, the protrusion 48 may be disposed at a first end of the slot 50, and / or in response to the valve 56 moving to a second position, the protrusion 48 may be disposed at a second end of the slot 50. It will be understood that in some embodiments, an inner surface of the socket 42 may include the protrusion 48 and an outer surface of the cylindrical portion 57 may include the slot 50.

[0048] In some embodiments, the slot 50 may include a neck portion 52. In some embodiments, the socket 42 may be asymmetrical and may limit the movement of the valve 56 to a first position, a second position, and an angle between the first and second positions. In some embodiments, the socket 42 may include a protrusion 53 that may contact an outer surface of the cylindrical portion 57 to provide resistance to moving the valve 56 between the first and second positions. In some embodiments, the cylindrical portion 57 may include a protrusion 53 that may contact the socket 42 and provide resistance to moving the valve 56 between the first and second positions.

[0049] In an embodiment, the barrel 57 may include a handle 58, which may be disposed on an exterior surface of the valve 56. In an embodiment, the handle 58 may include a rigid bar, a generally cylindrical grip, or any suitable handle. In response to a predetermined amount of rotation of the handle 58, the valve 56 may move between a first position and a second position. In an embodiment, the barrel 57 may include a position indicator (not shown) disposed on an exterior surface of the valve 56 that provides an indication of the position of the valve 56. In an embodiment, the protrusion 48 and the position of the protrusion 48 within the slot 50 may provide an indication of the position of the valve 56.

[0050] In some embodiments, the extension element 18 may include any suitable type of valve. In some embodiments, the extension element 18 may include a stem valve. In some embodiments, the arm 44 may not move to open or close a particular valve of the extension element 18.

[0051] 5, in some embodiments, the support device 10 may include a fluid pathway 40 therethrough. In some embodiments, the support device 10 may further include a pocket 62. In some embodiments, the cannula 32 may be secured within the pocket 62. In some embodiments, the cannula 32 may be swaged within the pocket 62. In some embodiments, swaging may include driving the cannula 32 into the pocket 62 to form an air-tight and water-tight seal and mechanical bond between the cannula 32 and the pocket 62. In some embodiments, the conical portion of the pocket 62 may bite into the proximal end of the cannula 32, thereby creating a positional locking of the cannula 32 within the pocket 62. In some embodiments, the portion of the pocket 62 distal to the conical portion may interfere with the cannula 32, thereby supporting any rotational torque applied to the cannula 32. In these embodiments, swaging may include changing the dimensions of cannula 32 by forcing cannula 32 into a die. In certain embodiments, swaging may form grooves, ridges, or shapes in cannula 32 by forming cannula 32 in a mold.

[0052] In an embodiment, the cannula 32 may be swaged into the pocket 62 to provide a liquid-tight and air-tight seal between the cannula 32 and the pocket 62 such that fluid does not pass between the wedge 64 and a surface of the pocket 62. In an embodiment, the pocket 62 may be free of adhesive. In an embodiment, the cannula 32 is secured within the pocket 62 without adhesive and / or without UV curing. In an embodiment, the cannula 32 may be secured within the pocket by one or more of swaging, adhesive, and UV curing.

[0053] 6A-6B, in an embodiment, the cannula 32 may include a distal end, a proximal end, and a lumen extending through the distal end of the cannula 32 and through the proximal end of the cannula 32. In an embodiment, the cannula 32 may include a plastic or metal material.

[0054] In some embodiments, the proximal end of the cannula 32 may include a wedge 64. In some embodiments, the wedge 64 may be formed by deep drawing. More specifically, in some embodiments, the deep drawing may begin with a blank, which may be flat, disk-shaped, or another suitable shape. In some embodiments, the blank may then be placed over a die or cavity, and a punch portion of a machining tool may force the blank into the die to form the cannula 32 and / or the wedge 64. In some embodiments, the blank may include a cannula shape or a tube shape. In some embodiments, the blank may undergo plastic deformation to form the wedge 64.

[0055] In an embodiment, the wedge 64 may be manufactured by other processes, which may include one or more of stamping, coating, or three-dimensional printing. In an embodiment, the length and / or diameter of the wedge 64 may vary to provide more lead in the material or a larger fixation area. In an embodiment, the distal end of the cannula 32 may be rounded or may include a rounded tip. In an embodiment, the distal end of the cannula 32 may be sharp. In an embodiment, the shape of the cannula 32 may vary.

[0056] 6C, in certain embodiments, one or more post-processing steps may occur after the cannula 32 is swaged and secured within the pocket 62. For example, the cannula 32 may be pressed into a die to form a retaining feature, such as a protrusion 66, bump, retaining ring, groove, ridge, or other shape, on the cannula 32 distal to the extension element 18.

[0057] In some embodiments, the retention feature may not fit through the portion of the pocket 62 distal to the cone-shaped portion that interferes with the cannula 32. In some embodiments, the retention feature may be configured to engage a protective cover to protect the lubricating film of the cannula 32, provide sterility and cleanliness to the cannula 32, and / or protect the clinician and patient from "sticking" with the cannula 32. In some embodiments, the retention feature may be configured to secure the cannula 32 within the extension element 18 or to secure the cannula 32 within the catheter assembly 12. In some embodiments, the retention feature may be used to secure the cannula 32 to other medical devices. In some embodiments, the retention feature may include hooks or barbs that may secure the cannula 32 within the catheter assembly 12 and / or within another medical device.

[0058] In an embodiment, the protrusion 66 may be annular. In an embodiment, the cannula 32 may include a first outer diameter at a proximal end 68 of the cannula 32 and a second outer diameter at a distal end 70 of the cannula 32. In an embodiment, the first outer diameter may be greater than the second outer diameter. In an embodiment, the first outer diameter and the second outer diameter may be manufactured by deep drawing. In an embodiment, the first outer diameter and the second outer diameter may be formed by one or more of stamping, coating, three-dimensional printing, bonding, and another suitable method. In an embodiment, multiple pieces may be assembled or bonded together to form the cannula 32. In an embodiment, the cannula 32 may include multiple protrusions 66. In an embodiment, a method of securing the cannula 32 within the support apparatus 10 may include providing the cannula 32. In an embodiment, the method may include forming the protrusions 66 on an outer surface of the cannula 32.

[0059] In some embodiments, the cannula 32 may include a lubricant and / or adhesive applied to an exterior surface of the cannula 32. In some embodiments, the lubricant and / or adhesive may be allowed to harden. In some embodiments, the method may include applying a lubricant and / or adhesive to the cannula 32.

[0060] In some embodiments, the method may include forming a wedge 64 at the proximal end of the cannula 32 by deep drawing or other methods. In some embodiments, the method may include providing a medical device into which the proximal end of the cannula 32 may be secured. In some embodiments, the medical device may include a support device 10 or another suitable device. In some embodiments, the medical device may include a needle assembly, a syringe, or another suitable device to facilitate the withdrawal of blood.

[0061] In an embodiment, the medical device may include a pocket 62 that may be configured to receive a proximal end 68 of the cannula 32. In an embodiment, the proximal end 68 of the cannula 32 may be inserted into the pocket 62 and the cannula 32 may then be swaged such that the proximal end 68 of the cannula 32 may be secured within the pocket 62. In an embodiment, the wedge 64 may provide a fluid seal after the cannula 32 is swaged into the pocket 62. In an embodiment, the method may include providing one or more other medical devices that may be coupled to the medical device to provide a fluid pathway through the medical device and the other medical device. In an embodiment, the other medical device may include a catheter assembly 12.

[0062] All examples and conditional language described herein are for educational purposes to help the reader understand the concepts that the inventors have contributed to the development of the present invention and technology, and should be interpreted as not being limited to such specifically described examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. 1. A support device for supporting a catheter assembly, comprising: a platform having a top surface and a bottom surface, the bottom surface configured to contact a patient's skin and at least a portion of the top surface configured to support a catheter assembly; an extension element coupled to the top surface of the platform, a distal end comprising a first connector configured to couple to the catheter assembly; a proximal end including a second connector; and an extension element disposed between the distal end and the proximal end and including a valve movable between a first position and a second position; a cannula extending distally from the distal end of the extension element and secured within the extension element; Equipped with in response to the valve moving to a first position, a fluid path extending through the cannula and the extension element is open and straight, and in response to the valve moving to a second position, the fluid path is closed; A support device wherein the valve comprises a socket and an arm, the arm having a distal end, a proximal end and a lumen extending through the distal end of the arm and the proximal end of the arm, the distal end of the arm comprising a ball portion configured to rotate within the socket, and the proximal end of the arm comprising the second connector.

2. 2. The support device of claim 1, wherein an outer surface of the ball portion comprises a protrusion, the socket comprises a slot, the slot comprises a first end and a second end, and in response to the valve moving to the first position, the protrusion is disposed at the first end of the slot, and in response to the valve moving to the second position, the protrusion is disposed at the second end of the slot.

3. 3. The support device of claim 2, wherein the slot includes a neck, and in response to the valve being moved to the first position, the projection passes through the neck to provide an audible indication.

4. 2. The support device of claim 1, wherein the socket comprises a plurality of protrusions contacting an outer surface of the arm, the plurality of protrusions configured to provide resistance to moving the valve from the first position to the second position.

5. 2. The support device of claim 1, wherein the valve comprises a socket and an arm, the arm having a distal end, a proximal end and a lumen extending through the distal end of the arm and the proximal end of the arm, the distal end of the arm comprising a plurality of flat surfaces configured to rotate within the socket, and the proximal end of the arm comprising the second connector.

6. The support device of claim 1 , wherein the cannula comprises a distal end, a proximal end, and a lumen extending through the distal and proximal ends, the proximal end of the cannula comprising a wedge.

7. The support device of claim 1 , wherein the cannula is swaged into the extension element.

8. 2. The support device of claim 1, wherein the valve comprises a socket and an arm, the arm having a distal end, a proximal end, and a lumen extending through the distal end of the arm and the proximal end of the arm, the distal end of the arm comprising a generally cylindrical shape configured to rotate within the socket, the socket being generally cylindrical, and the proximal end of the arm comprising the second connector.

9. 2. The support device of claim 1, wherein the valve further comprises a handle disposed on an exterior surface of the valve, and in response to a predetermined amount of rotation of the handle, the valve moves between the first position and the second position.

10. The support device of claim 1 , wherein an exterior surface of the cannula comprises protrusions.

11. The support apparatus of claim 1 , wherein the platform is wedge shaped.

12. The support device of claim 1 , wherein the portion of the upper surface comprises a groove configured to receive a catheter adapter of the catheter assembly.

13. The support apparatus of claim 1 , wherein the first connector comprises a snap feature, the snap feature comprises an arm, and the arm comprises a protrusion.

14. 1. A method for securing a cannula, comprising: providing a cannula, the cannula having a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; forming a wedge on the proximal end of the cannula; providing a medical device, the medical device comprising a pocket configured to receive a proximal end of the cannula; inserting the proximal end of the cannula into the pocket; swaging the proximal end of the cannula into the pocket; Including, The medical device includes a support device for supporting a catheter assembly, the support device comprising: a platform having a top surface and a bottom surface, the bottom surface configured to contact a patient's skin and at least a portion of the top surface configured to support a catheter assembly; an extension element coupled to a top surface of the platform; and the extension element comprises: a distal end including a first connector configured to couple to the catheter assembly; a proximal end comprising a second connector; the pocket is disposed between the distal end of the extension element and the proximal end of the extension element; The method, wherein the extension element comprises a valve, the valve comprises an arm, and in response to movement of the arm, the valve is configured to move between a first position in which a fluid path extending through the cannula and the extension element is open and straight, and a second position in which the fluid path is closed.

15. The method of claim 14 , wherein the wedge provides a fluid seal after the cannula is swaged into the pocket.

16. The method of claim 14, wherein forming the wedge at the proximal end of the cannula comprises deep drawing, stamping, coating, or three-dimensional printing.

17. The method of claim 14 , wherein the distal end of the arm comprises a ball, a cylinder, or a plurality of flat surfaces.

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