Delivery Devices and Catheter Systems

Abstract

The present disclosure relates to a delivery device and a catheter system. The delivery device is used to deliver an instrument through an intravenous catheter, and the delivery device may include a housing, a rotating element arranged in the housing, and an instrument. In some embodiments, the rotating element may include a groove that extends around at least a portion of the circumference of the rotating element. In some embodiments, the instrument may be arranged in the groove and / or between the rotating element and the housing. In some embodiments, in response to rotation of the rotating element relative to the housing, the instrument may advance distally through a port of the housing. In some embodiments, the instrument may include a guide wire, a probe, a tube, or a light tube.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices. In particular, the present disclosure generally relates to delivery devices for delivering devices through intravenous catheters and related systems. Background Art

[0002] For various reasons, inserting a needle into a patient's vasculature is prone to cause anxiety for both patients and clinicians. Blood drawing is a common source of needle insertions. Attempts have been made to draw blood from a patient's vasculature using a peripheral intravenous catheter (PIVC), which can reduce the number of needle insertions a given patient experiences.

[0003] A common type of IV catheter is an over-the-needle PIVC. As the name suggests, an over-the-needle PIVC can be mounted on an introducer needle that has a sharp distal tip. The sharp distal tip can be used to puncture the patient's skin and vasculature. Insertion of the PIVC into the vasculature can be performed after the vasculature has been punctured by the needle. The needle and PIVC are typically inserted through the skin at a shallow angle into the patient's vasculature, with the bevel of the needle facing away from the patient's skin. Once placement of the needle in the vasculature is confirmed, the clinician can temporarily occlude flow in the vasculature and withdraw the needle, leaving the PIVC in place for future blood draws and / or infusions.

[0004] Current PIVC blood drawing methods may have several limitations. Current PIVC blood drawing methods can be slow and inefficient, particularly when patients have difficult venous access or veins that are not easily accessible to clinicians. Similarly, blood samples obtained via PIVC may often need to be discarded due to concerns about sample quality. Furthermore, current PIVC blood drawing methods may result in tubing kinking. Furthermore, PIVCs may narrow, collapse, or become blocked over time, leading to PIVC failure.

[0005] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or operate only in environments such as described above. Rather, this background is merely provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0006] The present disclosure generally relates to a delivery device for delivering an instrument through an intravenous catheter and related systems and methods. In some embodiments, the instrument may include a guide wire, a probe, a tube, a light tube, or other suitable instrument. In some embodiments, the instrument may include a first end and a second end.

[0007] In some embodiments, the delivery device may include a housing, which may include a port. In some embodiments, the delivery device may include a rotating element, which may be disposed within the housing. In some embodiments, the rotating element may include a channel and a groove, which may extend around at least a portion of the circumference of the rotating element. In some embodiments, the delivery device may include the instrument, which may be disposed within the groove and / or between the rotating element and the housing. In some embodiments, the instrument may be advanced through the port in response to rotation of the rotating element relative to the housing.

[0008] In some embodiments, the delivery device can include a connector that can be fixed relative to the housing. In some embodiments, the connector can include a primary fluid path and a plurality of secondary fluid paths in fluid communication with the primary fluid path. In some embodiments, the connector can be fixed to the housing and / or integrally formed with the housing as a single unit. In some embodiments, the connector can include a Luer adapter.

[0009] In some embodiments, the rotational element can be configured to rotate relative to the housing between a first position and a second position. In some embodiments, in response to the rotational element being in the first position, the second end of the instrument can be aligned with the secondary fluid path, the passageway can be out of alignment with the secondary fluid path, and the first end of the instrument can be disposed in a first location or position. In some embodiments, the second end of the instrument can be aligned with a specific one of the secondary fluid paths.

[0010] In some embodiments, in response to the rotating element being in the second position, the channel may be aligned with the secondary fluid path, the second end of the instrument may not be aligned with the secondary fluid path, and the first end of the instrument may be disposed in the second location.

[0011] In some embodiments, the instrument can be advanced distally through the port in response to rotation of the rotational element from the second position to the first position. In some embodiments, the rotational element can be rotated from the first position to the second position in response to rotation of the rotational element less than a full turn or other amount.

[0012] In some embodiments, the rotational element can be configured to rotate relative to the housing between a first position, a second position, and a third position. In some embodiments, in response to the rotational element being in the third position, the second end of the instrument can be aligned with the secondary fluid path, the channel can be aligned with the secondary fluid path, and the first end of the instrument can be disposed in the third location.

[0013] In some embodiments, in response to the rotation of the rotation element from the third position to the first position, the instrument can be advanced distally through the port. In some embodiments, in response to the rotation of the rotation element being approximately one-quarter of a full turn or other amount, the rotation element can be rotated from the first position to the third position.

[0014] In some embodiments, the first position can correspond to a blood drawing position configured to collect blood from a patient. In some embodiments, a blood collection device can be coupled to the connector. In some embodiments, the instrument can include a tube that can assist in collecting blood from a patient. In some embodiments, the tube can include a variable inner diameter and / or a variable outer diameter. In some embodiments, the second position can correspond to an infusion position configured to infuse fluid into the patient's vascular system. In some embodiments, a fluid infusion device can be coupled to the connector. In some embodiments, the third position can correspond to a flushing position configured to flush the channel and the tube. Thus, in some embodiments, the delivery device can be configured to provide multiple functions, including blood drawing, infusion, and flushing, via a single port.

[0015] In some embodiments, the catheter system may include a catheter assembly and a conveying device, and the conveying device may be coupled to the catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter and / or a catheter, and the catheter may extend distally from the catheter adapter. In some embodiments, in response to the rotating element being in a first position, the first end of the instrument may be arranged in a first location, and the first location may be distal to the distal end of the catheter. In some embodiments, in response to the rotating element being in a second position, the first end of the instrument may be arranged in a second location, and the second location may be proximal to the distal end of the catheter. In some embodiments, in response to the rotating element being in a third position, the first end of the instrument may be arranged in a third location, and the third location may be proximal to the distal end of the catheter and / or distal to the second position.

[0016] In some embodiments, the catheter system can include an extension tube, which can include a distal end and a proximal end. In some embodiments, the distal end of the extension tube can be coupled to a catheter adapter. In some embodiments, the proximal end of the extension tube can be coupled to the housing of the delivery device. In some embodiments, the proximal end of the extension tube can be integrated into a port of the housing, which can eliminate the need for manual connection of the delivery device to the extension tube. In some embodiments, the distal end of the extension tube can be integrated into a port of the catheter adapter.

[0017] In some embodiments, the groove can include a width that is approximately equal to or slightly larger than the width of the instrument, which can help support the instrument and / or reduce the risk of kinking the instrument. In some embodiments, the groove can extend inward from the circumference of the rotating element. In some embodiments, the groove can extend inward from the circumference of the rotating element to the central rotation axis of the rotating element and / or extend inward toward the central rotation axis of the rotating element. In some embodiments, the second end of the instrument can be secured within the delivery device, for example, secured within the groove.

[0018] In some embodiments, the housing may include a first port and a second port. In some embodiments, the housing may include a protrusion. In some embodiments, the rotating element may include an upper end and a lower end. In some embodiments, the upper end may include a connector. In some embodiments, the rotating element may include an inner cavity that extends through the upper end and the lower end. In some embodiments, the rotating element may include an upper diaphragm and / or a lower diaphragm disposed within the inner cavity.

[0019] In some embodiments, in response to connection of the medical device to the connector, the upper diaphragm can be configured to move toward the lower diaphragm to allow fluid to flow around the upper diaphragm. In some embodiments, in response to the rotational element being rotated to a first position: the lower diaphragm can contact the protrusion and move toward the opening; the lower diaphragm can divide the inner cavity into an upper chamber and a lower chamber sealed from the upper chamber; the upper chamber can be in fluid communication with the second end of the instrument; the instrument can extend through the first port; and the first end of the instrument can be positioned at a specific first location. In some embodiments, the second port can be in fluid communication with the lower chamber.

[0020] In some embodiments, in response to the rotational element being rotated to the second position, the lower diaphragm can move away from the opening; the upper chamber, the lower chamber, and the second end of the device can be in fluid communication; and the first end of the device can be positioned at a specific second location. In some embodiments, the inner chamber can include a spring that can push the upper diaphragm upward against the housing to prevent fluid from flowing around the upper diaphragm. In some embodiments, the delivery device can include a channel disposed between the lower end of the rotational element and the housing. In some embodiments, the channel can be in fluid communication with the lower chamber.

[0021] The objects and advantages of the embodiments will be realized and attained at least by the elements, features and combinations particularly pointed out in the claims.It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0023] Figure 1A is an upper perspective view of an example catheter system according to some embodiments;

[0024] Figure 1B According to some embodiments Figure 1A An exemplary rotating element of a catheter system;

[0025] Figure 1C According to some embodiments Figure 1A A partial enlarged cross-sectional view of an exemplary delivery device of a catheter system;

[0026] Figure 2A According to some embodiments Figure 1A A top view of a delivery device of a catheter system showing the rotation element in an exemplary first position;

[0027] Figure 2B According to some embodiments Figure 1A A top view of the catheter system showing the rotating element in a first position;

[0028] Figure 2C According to some embodiments Figure 1A a cross-sectional view of a delivery device of a catheter system showing the rotating element in a first position;

[0029] Figure 3A According to some embodiments Figure 1A a top view of a delivery device of a catheter system showing the rotational element in an exemplary second position;

[0030] Figure 3B According to some embodiments Figure 1A A top view of the catheter system showing the rotating element in a second position;

[0031] Figure 3C According to some embodiments Figure 1A a cross-sectional view of a delivery device of a catheter system showing the rotation element in a second position;

[0032] Figure 4A According to some embodiments Figure 1A A top view of a delivery device of a catheter system showing the rotation element in an exemplary third position;

[0033] Figure 4B According to some embodiments Figure 1A A top view of the catheter system showing the rotating element in a third position;

[0034] Figure 4C According to some embodiments Figure 1A a cross-sectional view of a delivery device of a catheter system showing the rotating element in a third position;

[0035] Figure 5A According to some embodiments Figure 1A An upper perspective view of a delivery device of a catheter system;

[0036] Figure 5B According to some embodiments Figure 1A a cross-sectional view of a delivery device of a catheter system;

[0037] Figure 6Ais an upper perspective view of another catheter system according to some embodiments;

[0038] Figure 6B yes Figure 6A A cross-sectional view of an exemplary delivery device of a catheter system;

[0039] Figure 6C yes Figure 6A a cross-sectional view of a delivery device of a catheter system of FIG. 1 showing an exemplary medical device coupled to an exemplary connector of the delivery device and an exemplary rotational element in an exemplary first position;

[0040] Figure 6D According to some embodiments Figure 6A an enlarged cross-sectional view of a delivery device of a catheter system showing the rotating element in a first position;

[0041] Figure 7A According to some embodiments Figure 6A an upper perspective view of a catheter system of FIG. 1 showing the rotating element in an exemplary second position;

[0042] Figure 7B yes Figure 6A a cross-sectional view of a delivery device of a catheter system showing the rotation element in a second position;

[0043] Figure 7C According to some embodiments Figure 7B an enlarged cross-sectional view of a delivery device of a catheter system showing the rotation element in a second position;

[0044] Figure 8A yes Figure 6A a cross-sectional view of a delivery device of a catheter system showing the rotating element in a first position;

[0045] Figure 8B yes Figure 6A a cross-sectional view of a delivery device of a catheter system showing the rotational element in a second position; and

[0046] Figure 8C According to some embodiments Figure 6A A partially enlarged cross-sectional view of a delivery device of a catheter system. DETAILED DESCRIPTION

[0047] As used in this disclosure, the term "distal" refers to the portion of a catheter system or its components that is away from the user, and the term "proximal" refers to the portion of a catheter system or its components that is closer to the user. As used in this disclosure, the term "user" may refer to a clinician, doctor, nurse, or any other care provider, and may include support personnel.

[0048] Referring now to FIG1 , in some embodiments, a delivery device 10 can be configured to deliver a device 11 through an intravenous catheter 12. In some embodiments, the intravenous catheter 12 can include a PIVC, a peripherally inserted central catheter (PICC), a midline catheter, or other suitable catheter. In some embodiments, the device 11 can include a guidewire, a stylet, a tube, a light, or other suitable device.

[0049] In some embodiments, the delivery device 10 can include a housing 14, which can include a port 15. In some embodiments, the delivery device 10 can include a rotational element 16, which can be disposed within the housing 14. In some embodiments, in response to rotational element 16 relative to the housing 14 in a first direction (e.g., clockwise), the instrument 11 can be advanced in a distal direction. In some embodiments, the first end 17 of the instrument 11 can be advanced and / or retracted. In some embodiments, in response to rotational element 16 relative to the housing 14 in a direction opposite to the first direction (e.g., counterclockwise), the instrument 11 can be retracted in a proximal direction.

[0050] In some embodiments, the rotational element 16 may include a connector 18, which may include a Luer adapter. In some embodiments, the Luer adapter may be coupled to a needleless connector. In some embodiments, the connector 18 may include a needleless connector that may be directly coupled to the rotational element 16. In some embodiments, the medical device 21 coupled to the connector 18 may not move along the axis of the intravenous catheter 12. In some embodiments, the medical device 21 may be integrated with the connector 18. In some embodiments, the medical device 21 may be integrally formed with the connector 18 as a single unit.

[0051] In some embodiments, the medical device 21 may include a blood collection device, an infusion device, or other medical device. In some embodiments, the blood collection device may include a syringe, a vacuum tube, a blood collection tube, a holder (e.g., Figure 1A In some embodiments, the retainer can include a cannula configured to pierce a seal of a particular blood collection device. In some embodiments, the connector 18 can be coupled to and / or integrally formed with the rotating element 16. In some embodiments, the connector 18 can be integrally formed with the rotating element 16 as a single unit. In some embodiments, the medical device 21 can rotate with the rotating element 16.

[0052] In some embodiments, by rotating the rotational element 16, the delivery device 10 can be used for multiple purposes, such as one or more of the following: blood drawing, infusion, and flushing. Furthermore, in some embodiments, the delivery device 10 can eliminate the need to connect a completely new delivery device 10 each time a blood draw is needed. In some embodiments, because the delivery device 10 can be used for multiple purposes and reduces the need to disconnect and connect the device from the catheter assembly 20, the delivery device 10 can reduce the risk of the intravenous catheter 12 being dislodged from the insertion site. In some embodiments, patients can feel more confident knowing that the delivery device 10 has multiple purposes (e.g., blood drawing, infusion, and flushing).

[0053] In some embodiments, the delivery device 10 can reduce the priming volume. In some embodiments, the delivery device 10 can facilitate the infusion of a drug through the device 11 to deliver the drug to a location in the vasculature through accelerated hemodilution. In some embodiments, the distal end 22 of the intravenous catheter 12 can include one or more diffusion holes. In these and other embodiments, the drug can be delivered through the device 11 while other fluids are delivered to the patient via the diffusion holes (which can be disposed at the distal end 22 of the intravenous catheter 12), which can facilitate dilution of the drug during delivery within the vascular system and reduce the risk of venous injury due to high drug concentrations.

[0054] In some embodiments, catheter system 24 may include catheter assembly 20 and delivery device 10, which may be coupled to catheter assembly 20. In some embodiments, catheter assembly 20 may include catheter adapter 26 and / or intravenous catheter 12, which may extend distally from catheter adapter 26.

[0055] In some embodiments, the delivery device 10 can be coupled directly to the proximal end of the catheter adapter 26. In these and other embodiments, the catheter assembly 20 can include a straight or non-integrated catheter assembly. In some embodiments, the catheter assembly 20 can include an integrated catheter assembly. More specifically, in some embodiments, the catheter adapter 26 of the catheter assembly 20 can include an integrated extension tube, such as a BD NEXIVA TM Closed IV catheter system, BD NEXIVA TM DIFFUSICS TM Closed IV catheter system, or BD PEGASUS TM Secure closed IV catheter system.

[0056] In some embodiments, the catheter system 24 can include an extension tube 28, which can include a distal end 30 and a proximal end 32. In some embodiments, the extension tube 28 can be short, which can allow the device 11 to be shorter. In some embodiments, the distal end 30 of the extension tube 28 can be coupled to the catheter adapter 26. In some embodiments, the proximal end 32 of the extension tube 28 can be coupled to the housing 14 of the delivery device 10. In some embodiments, the proximal end 32 of the extension tube 28 can be integrated into the port 15 of the housing 14, which can eliminate the need for manual connection of the delivery device to the extension tube. In some embodiments, the distal end 30 of the extension tube 28 can be integrated into the port 34 of the catheter adapter 26. In some embodiments, the delivery device 10 can reduce the number of user-initiated connections, which can reduce stress and contamination risk for the user. Furthermore, in some embodiments, the user is not limited to a small selection of needleless connectors, nor is the blood drawing experience tied to a specific connector.

[0057] Now refer to Figure 1B In some embodiments, the rotating element 16 can include a support surface or groove 36 that can extend around at least a portion of the circumference of the rotating element 16. In some embodiments, the width of the groove 36 can be approximately equal to or slightly larger than the instrument 11, which can help support the instrument 11 and / or reduce the risk of kinking the instrument 11. In some embodiments, the length of the groove 36 can extend inwardly from the circumference of the rotating element 16, such as Figure 1B As shown, this can help support the instrument 11. In some embodiments, the instrument 11 can be disposed within the recess 36 and / or between the rotating element 16 and the housing 14. In some embodiments, the top surface of the rotating element 16 can include a protrusion 38 that can be proximate to a user interface 40 configured to be grasped by a user. Figure 1B Also shown is an exemplary O-ring 50 , which will be explained in greater detail below.

[0058] In some embodiments, the delivery device 10 can include a torque limiter that can limit the torque of the user interface 40. In some embodiments, the torque limiter can limit the torque by slipping (e.g., with a friction plate slip clutch, magnetic particles, or a hysteresis torque limiter) or by completely removing the load (e.g., with a shear pin, a synchronous magnet, a ball brake, or a pawl and spring torque limiter). More specifically, in some embodiments, the user interface 40 can be coupled to the rotating element 16 and rotate with the rotating element 16 in response to a torque below a predetermined threshold.

[0059] In some embodiments, the user can grasp and turn the user interface 40 to advance and / or retract the instrument 11. In some embodiments, in response to the torque of the user interface 40 exceeding a threshold, the user interface 40 can be released from the rotation element 16 or slide relative to the rotation element 16, which can prevent the instrument 11 from causing blood vessel damage, kinking, and / or buckling. In some embodiments, when the user interface 40 is released from the rotation element 16 or slides relative to the rotation element 16, the user may not be able to rotate the rotation element 16 via the user interface 40. In some embodiments, the rotation element 16 may not include a torque limiter and / or the user interface 40. In these and other embodiments, the protrusion 38 can serve as a user grip.

[0060] In some embodiments, rotation of the rotating element 16 relative to the housing 14 can be achieved by direct user input, wherein the user can physically interact with or touch the rotating element 16. For example, the user's hand can grasp the protrusion 38 and / or the user interface 40 to rotate the rotating element 16. In other embodiments, the rotation of the rotating element 16 relative to the housing 14 can be driven by a mechanical connection. In these and other embodiments, the user may not physically interact with or touch the rotating element 16, and / or the rotation of the rotating element 16 may occur in response to a linear or non-rotational motion from the user. In some embodiments, the device can convert the user's linear or non-rotational motion into a rotation of the rotating element 16. In some embodiments, the instrument 11 can be connected to a power source via a rotatable permissive contact. In some embodiments, the housing 14 and / or the rotating element 16 may include a battery and / or a power switch.

[0061] In some embodiments, the rotating element 16 may include a channel 42. In some embodiments, the outer opening of the channel 42 may be arranged above the instrument 11 and / or the groove 36, for example, Figure 1B In some embodiments, the outer opening of channel 42 can be positioned below instrument 11 and / or recess 36. In some embodiments, the outer opening of channel 42 can be positioned within recess 36. In some embodiments, rotating element 16 can rotate or pivot about central rotation axis 44. In some embodiments, the outer opening of channel 42 can be positioned adjacent recess 36.

[0062] Now refer to Figure 1CIn some embodiments, the housing 14 can include a generally cylindrical inner surface 46 that can allow the generally cylindrical outer surface of the rotating element 16 to rotate relative to the housing 14. In some embodiments, the housing 14 can include an inner surface having a shape other than a generally cylindrical shape, and the outer surface of the rotating element 16 can include a shape corresponding to the other shape that allows the rotating element 16 to rotate relative to the housing 14. In some embodiments, the housing 14 can include an upper ledge (not shown) that can prevent the rotating element 16 from exiting the opening 48 of the housing 14. In some embodiments, the delivery device 10 can include one or more seals positioned between the generally cylindrical inner surface 46 of the housing 14 and the generally cylindrical outer surface of the rotating element 16. In some embodiments, the seals can include one or more gaskets and / or one or more O-rings 50.

[0063] like Figures 1B-1C As shown, in some embodiments, a specific O-ring 50 can be annular and extend around the circumference of the rotating element 16 and between the rotating element 16 and the housing 14. In some embodiments, the specific O-ring 50 can isolate the fluid path of the delivery device 10 (including the channel 42 and the fluid path 49, which extends around the rotating element 16 between the groove 36 and the housing 14 and around the instrument 11 and out of the port 15) from the external environment of the delivery device 10. In some embodiments, the fluid path 49 can be adjacent to the channel 42 and in fluid communication with the channel 42.

[0064] Now refer to Figures 2A-2C According to some embodiments, the rotational element 16 is shown in a first position. In some embodiments, in response to the rotational element 16 being in the first position, the first end 17 of the instrument 11 can be arranged in a first location or position, which can be distal to the distal end 22 of the intravenous catheter 12 (e.g., at Figure 1A ). In some embodiments, when the rotating element 16 is in the first position, the instrument 11 can extend directly out of the port 15 without being wrapped around the rotating element 16. In other embodiments, when the rotating element 16 is in the first position, the instrument 11 can be wrapped around all or a portion of the circumference of the rotating element 16.

[0065] In some embodiments, the housing 14 may include housing markings 54 that can be aligned with rotating element markings 56 on the rotating element 16 when the rotating element 16 is in the first position. In some embodiments, the housing markings 54 and / or the rotating element markings 56 can include indentations, protrusions, characters, etc. In some embodiments, the housing markings 54 and / or the rotating element markings 56 can include detents that provide resistance to movement of the rotating element 16 from the detents. In some embodiments, when the rotating element 16 is in the first position, the housing markings 54 can be aligned with a particular rotating element marking 56 (e.g., a "D" for "suction" or other characters, indentations, detents, protrusions, colors, etc.).

[0066] In some embodiments, the connector 18 can include a primary fluid path 58 and a plurality of secondary fluid paths 60 in fluid communication with the primary fluid path 58. In some embodiments, in response to the rotational element 16 being in the first position, the second end 62 of the instrument 11 can be aligned with the secondary fluid path 60, the channel 42 can be misaligned with the secondary fluid path 60, and the first end 17 of the instrument 11 can be disposed in the first position. Figure 2A As shown, for example, in response to the rotational element 16 being in the first position, the secondary fluid path 60a with which the second end 62 of the instrument is aligned can be out of fluid communication with the channel 42 and / or the fluid path 49 or can be fluidically isolated from the channel 42 and / or the fluid path 49. In some embodiments, the space between the groove 36 and the outer surface of the instrument 11 can be sealed so that fluid does not leak from the secondary fluid path 60a through the groove 36 surrounding the instrument 11. In more detail, in some embodiments, a seal can be disposed around the second end 62 of the instrument 11 or within the housing 14 to fill the space and prevent fluid from contacting all or a portion of the groove 36 and preventing fluid from traveling within the fluid path 49. In some embodiments, the seal can include an adhesive and / or a potting agent.

[0067] In some embodiments, the first end 17 of the instrument 11 can be movable, while the second end 62 of the instrument 11 can be fixed. For example, when the rotating element 16 is in the first position, the second end 62 of the instrument 11 can be fixed within the groove 36 and / or adjacent to the secondary fluid path 60. In some embodiments, a portion of the groove 36 disposed inwardly from the circumference can be a portion of a slit or tunnel. In some embodiments, the instrument 11 can be disposed within the groove 36 and supported on both sides of the instrument 11. In some embodiments, the groove 36 can extend toward the central rotational axis 44 of the rotating element 16.

[0068] In some embodiments, the first position can correspond to a blood drawing position configured to collect blood from a patient. In some embodiments, when the rotating element 16 is in the first position, blood can be drawn from the patient by the instrument 11 into the secondary fluid path 60a, the primary fluid path 58, and the medical device 21, which can include a blood collection device. In some embodiments, blood can be prevented from traveling elsewhere within the delivery device 10, which can save the size of the collected blood sample. In some embodiments, a blood collection device such as a syringe, a vacuum tube, a blood collection tube, a holder, etc. can be coupled to the connector 18. In some embodiments, the instrument 11 can include a tube, which can assist in collecting blood from the patient. In some embodiments, the tube can include a variable inner diameter and / or a variable outer diameter.

[0069] Now refer to Figures 3A-3C According to some embodiments, the rotational element 16 is shown in a second position. In some embodiments, the second position may correspond to an infusion position configured to infuse a fluid into the patient's vasculature. In some embodiments, a fluid infusion device may be coupled to the connector 18. In some embodiments, the rotational element 16 may be configured to rotate relative to the housing 14 between the first position and the second position.

[0070] In some embodiments, in response to the rotational element 16 being in the second position, the first end 17 of the instrument 11 can be disposed in a second location or position, which can be proximal to the distal end 22 of the intravenous catheter 12. In some embodiments, in response to the rotational element 16 being in the second position, the passage 42 can be aligned with the secondary fluid path 60, the second end 62 of the instrument 11 can be misaligned with the secondary fluid path 60, and the first end 17 of the instrument 11 can be disposed in the second location. In some embodiments, when the rotational element 16 is in the second position, the instrument 11 can be wrapped around all, a portion, or a majority of the circumference of the rotational element 16.

[0071] In some embodiments, responsive to rotational element 16 being in the second position, fluid may be injected from medical device 21 through primary fluid path 58, through secondary fluid path 60 c, into fluid path 49, through extension tube 28, and through catheter assembly 20. In some embodiments, responsive to rotational element 16 being in the second position, fluid may be prevented from flowing into instrument 11, which may not be aligned with secondary fluid path 60 and / or may be sealed relative to secondary fluid path 60.

[0072] In some embodiments, the instrument 11 can be advanced distally through the port in response to rotation of the rotational element 16 from the second position to the first position. In some embodiments, the rotational element 16 can be rotated from the first position to the second position in response to rotation of the rotational element 16 by less than a full turn or other amount. In some embodiments, the rotational element 16 can be rotated from the first position to the second position in response to rotation of the rotational element 16 counterclockwise by less than a full turn or other amount. However, it should be understood that the configuration of the delivery device 10 can be reversed, and in some embodiments, the rotational element 16 can be rotated from the first position to the second position in response to rotation of the rotational element 16 clockwise by less than a full turn or other amount. In some embodiments, when the rotational element 16 is in the second position, the housing marking 54 can be aligned with a specific rotational element marking 56 (e.g., an "I" or other character, indentation, detent, protrusion, etc. for "injection").

[0073] Now refer to Figures 4A-4C In some embodiments, the rotational element 16 can be configured to rotate relative to the housing 14 between a first position, a second position, and a third position. In some embodiments, the third position can correspond to a flushing position configured to flush the channel 42 and the instrument 11, which can include tubing. Thus, in some embodiments, the delivery device 10 can be configured to provide multiple functions, including blood withdrawal, infusion, and flushing, via a single port (e.g., port 15). In some embodiments, the groove 36 can be flushed when the rotational element 16 is in the third position.

[0074] In some embodiments, the device can include a tube that can have properties and geometries that vary along the length of the tube. In some embodiments, the properties and geometries of the tube can be varied to locally increase the stiffness or compliance of the tube, reduce the time to fill the blood collection device with blood, reduce the risk of sample degradation (hemolysis, etc.), or reduce venous trauma and associated downstream trauma.

[0075] In some embodiments, in response to the rotational element 16 being in the third position, the second end 62 of the device 11 can be aligned with the secondary fluid path 60, the channel 42 can be aligned with the secondary fluid path 60, and the first end 17 of the device 11 can be disposed in a third location or position, which can be proximal to the distal end 22 of the intravenous catheter 12 and / or distal to the second location. In some embodiments, the device 11 can be wrapped around all, a portion, or a majority of the circumference of the rotational element 16 when the rotational element 16 is in the third position.

[0076] In some embodiments, the instrument 11 can be advanced distally through the port 15 in response to rotation of the rotational element 16 from the third position to the first position. In some embodiments, the rotational element 16 can be rotated from the first position to the third position in response to approximately one-quarter of a full rotation counterclockwise or clockwise, or other amounts. In some embodiments, when the rotational element 16 is in the third position, the housing indicia 54 can be aligned with a specific rotational element indicia 56 (e.g., an "F" for "flush" or other character, indentation, detent, protrusion, etc.).

[0077] In some embodiments, in response to the rotational element 16 being in the third position, fluid can be flushed from the medical device 21 through the primary fluid path 58, through the secondary fluid path 60b, into the fluid path 49, through the extension tube 28, and through the catheter assembly 20. In some embodiments, in response to the rotational element 16 being in the third position, fluid can also be flushed from the medical device 21 through the primary fluid path 58, through the secondary fluid path 60d, and through the instrument 11. In some embodiments, all fluid paths within the delivery device 10 can be configured to be flushed in response to the rotational element 16 being in the third position.

[0078] In some embodiments, the rotational element 16 can be in a locked state in which the rotational element 16 is prevented from rotating relative to the housing 14. In some embodiments, coupling of the medical device to the connector 18 and / or activation of a manual user input feature can unlock the rotational element 16, thereby allowing rotation relative to the housing 14. In some embodiments, when the rotational element 16 is in the locked state, the instrument 11 can be partially or fully retracted. In some embodiments, when the rotational element 16 is in the locked state, the first end of the instrument 11 can be proximate to a second location. In some embodiments, the delivery device 10 can include an automatic passive feature that allows the rotational element 16 to rotate in response to coupling of the medical device 21 to the connector 18. In some embodiments, when the rotational element is in the "locked" state, the instrument 11 can be prevented from prematurely leaving the instrument 11. In some embodiments, the delivery device 10 can include a manual user input feature, such as a lever or button, that allows the rotational element 16 to rotate or prevents the rotational element 16 from rotating.

[0079] although Figure 1AA clamp is shown on the extension tube 28, but in some embodiments, the clamp may not be on the extension tube 28. In some embodiments, the rotational element 16 can be configured to rotate between a first position, a second position, a third position, and a fourth position relative to the housing 14. In some embodiments, the fourth position can correspond to a closed or sealed position in which the channel 42 and the second end 62 of the instrument 11 are not aligned with and / or sealed relative to the secondary fluid path 60. In some embodiments, in response to the rotational element 16 being in the fourth position, one or more fluid paths of the delivery device 10 can be sealed from the environment external to the delivery device 10.

[0080] In some embodiments, the fourth position can be positioned between the first and second positions, or between the second and third positions. In some embodiments, the rotatable element 16 can be rotated clockwise or counterclockwise from the first, second, or third positions to reach the fourth position. In some embodiments, when the rotatable element 16 is in the fourth position, the housing marking 54 can be aligned with a specific rotatable element marking 56 (e.g., a "C" or other character, indentation, detent, protrusion, etc., representing "closed").

[0081] Now refer to Figures 5A-5B In some embodiments, connector 18 can include a base 64 and an upper portion 66 extending upward from base 64. In some embodiments, upper portion 66 of base 64 can include a male or female Luer adapter with a Luer slip feature or a Luer lock feature, or other suitable adapter. In some embodiments, base 64 can be fixed to housing 14 and / or integrally formed with housing 14 as a single unit. In some embodiments, secondary fluid path 60 can extend along and / or through base 64 to connect to primary fluid path 58.

[0082] In some embodiments, the base 64 can include one or more seals 68 that can be configured to align with the second end 62 of the instrument 11 and / or the groove 36 near the second end 62 of the instrument 11 when the rotating element 16 is arranged in one or more specific positions. For example, when the rotating element is in the first position, a specific seal 68 can be aligned with the channel 42 to seal the channel from the secondary fluid path 60, thereby preventing blood from flowing into the channel 42, such as during blood collection. As another example, when the rotating element is in the second position, a specific seal 68 can be aligned with the second end 62 of the instrument 11 to seal the instrument 11 from the secondary fluid path 60, thereby preventing fluid from flowing through the instrument, such as during an infusion. In some embodiments, the seal 68 can include a protrusion configured to prevent fluid from flowing through the groove 36 and / or the second end 62 of the instrument 11.

[0083] In some embodiments, the rotating element 16 can rotate between one or more of the following: a first position, a second position, a third position, and a fourth position. In some embodiments, infusion can occur through the groove 36, and the rotating element 16 may not include the channel 42. Figure 5B As shown, in some embodiments, another O-ring 69 can be disposed around the base 64. In some embodiments, the O-ring 69 can be annular, surrounding the circumference of the base 64 and extending between the rotating element 16 and the housing 14. In some embodiments, the O-ring 69 can prevent fluid from leaking between the housing 14 and the rotating element 16.

[0084] Now refer to Figure 6A , shows a delivery device 70 according to some embodiments. In some embodiments, the delivery device 70 can include or correspond to the delivery device 10. In some embodiments, the delivery device 70 can be similar or identical to the delivery device 10 disclosed in Figures 1-5 of the present disclosure with respect to one or more included components and / or operation. In some embodiments, the housing 14 can include a first port 71 and a second port 72.

[0085] In some embodiments, the second port 72 can be coupled to the distal end of another extension tube 74. In some embodiments, the distal end of the extension tube 74 can be integrated into the second port 72, which can eliminate the need for manual connection of a delivery device to the other extension tube. In some embodiments, the proximal end of the other extension tube 74 can include a connector 76 that can be coupled to a medical device, such as an infusion set. In some embodiments, a blood collection set can be coupled to the connector 18 at the same time as the infusion set is coupled to the connector 76.

[0086] Now refer to Figure 6B In some embodiments, the rotating element 16 can include an upper end 78 and a lower end 80. In some embodiments, the upper end 78 can include a connector 18 and an upper opening 81. In some embodiments, the rotating element 16 can include an inner cavity 82 that can extend through the upper end 78 and the lower end 80. In some embodiments, the rotating element 16 can include an upper diaphragm 84 and / or a lower diaphragm 86 disposed within the inner cavity 82.

[0087] In some embodiments, the lower diaphragm 86 can be disposed in the tapered portion of the lumen 82, and the bottom of the lower diaphragm 86 can be wider than the top of the lower diaphragm 86, which can prevent undesired upward movement of the lower diaphragm 86. In some embodiments, the top of the lower diaphragm 86 can include a protrusion 88 configured to fit within a groove 90 of the upper diaphragm 84. In some embodiments, the protrusion 92 of the lower housing 14 can be disposed within a groove 94 at the bottom of the lower diaphragm 86, which can help center the lower diaphragm 86 within the lumen 82.

[0088] Now refer to Figure 6C In some embodiments, in response to connection of the medical device 21 to the connector 18 , the upper diaphragm 84 can be configured to move toward the lower diaphragm 86 to allow fluid to flow around the upper diaphragm 84 .

[0089] Now refer to Figures 6C-6D In some embodiments, housing 14 may include a protrusion 94. In some embodiments, in response to rotation of rotational element 16 to a first position, lower diaphragm 86 may contact protrusion 94 and move toward upper opening 81. Lower diaphragm 86 may separate lumen 82 into an upper chamber 96 and a lower chamber 98 sealed from upper chamber 96. Upper chamber 96 may be in fluid communication with second end 62 of instrument 11. Instrument 11 may extend through first port 71. First end 17 of instrument 11 may be positioned at a specific first location. In some embodiments, second port 72 may be in fluid communication with lower chamber 98.

[0090] In some embodiments, when upper diaphragm 84 moves toward lower diaphragm 86, upper chamber 96 can be in fluid communication with upper opening 81. In some embodiments, when upper diaphragm 84 is removed from connector 18 after medical device 21 is removed from connector 18, upper chamber 96 can be out of fluid communication with upper opening 81. In some embodiments, upper chamber 96 can be disposed between a lower surface of upper diaphragm 84 and an upper surface of lower diaphragm 86. In some embodiments, lower chamber 98 can be disposed between a lower surface of lower diaphragm 86 and housing 14.

[0091] Now refer to Figures 7A-7C In some embodiments, in response to rotation of rotational element 16 to the second position, lower diaphragm 86 can move away from upper opening 81; upper chamber 96, lower chamber 98, and second end 62 of instrument 11 can be in fluid communication; and first end 17 of instrument 11 can be positioned at a specific second location. In some embodiments, lumen 82 can include a spring 100 that can push upper diaphragm 84 upward against housing 14 to prevent fluid from flowing around upper diaphragm 84.

[0092] although Figure 6A and Figure 7AA clamp is shown on the extension tube 28, but in some embodiments, the clamp may not be on the extension tube 28. In some embodiments, the rotational element 16 can be configured to rotate between another position relative to the housing 14, which can correspond to a closed or sealed position. In some embodiments, when the rotational element 16 is in the closed position, one or more fluid paths of the delivery device 10 can be sealed from the environment external to the delivery device 10. For example, when the rotational element 16 is in the closed position, the upper diaphragm 84 and / or the lower diaphragm 86 can seal the passage 102 and / or the second port 72 and prevent fluid communication between the second port 72 and the lower chamber 98.

[0093] Now refer to Figure 8A , according to some embodiments, the rotating element 16 is shown in a first position. Referring now to Figure 8B , according to some embodiments, the rotating element 16 is shown in a second position. Referring now to Figure 8C In some embodiments, the delivery device 70 can include one or more seals between the generally cylindrical inner surface 46 of the housing 14 and the generally cylindrical outer surface of the rotating element 16. In some embodiments, the seals can include gaskets and / or O-rings 50.

[0094] In some embodiments, the delivery device 70 can include a passage 102 disposed between the lower end 80 of the rotating element 16 and the housing 14. In some embodiments, the passage 102 can be in fluid communication with the second port 72 and the lower chamber 98 when the rotating element 16 is in the first position and / or the second position.

[0095] All examples and conditional language listed herein are intended for teaching purposes to help readers understand the present invention and the concepts contributed by the inventors to further develop this field, and should be interpreted as not being limited to such specific examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and modifications may be made thereto without departing from the spirit and scope of the present invention.

Claims

1. A delivery device for delivering a device through an intravenous catheter, characterized in that: The conveying device comprises: a housing including a port; A connector, wherein the connector comprises: primary fluid paths; and a plurality of secondary fluid paths in fluid communication with the primary fluid path; a rotating element disposed within the housing and coupled to the connector, wherein the connector extends through the rotating element, wherein the rotating element comprises: a groove extending around at least a portion of the circumference of the rotating element; and Channels; and the instrument, the instrument comprising a first end and a second end, wherein the instrument is disposed within the recess and between the rotating element and the housing, wherein the rotating element is configured to rotate relative to the housing between a first position and a second position, wherein, in response to the rotational element being in the first position, the second end of the instrument is aligned with the plurality of secondary fluid pathways, the passageway is not aligned with the plurality of secondary fluid pathways, and the first end of the instrument is disposed in a first location; wherein, in response to the rotational element being in the second position, the passage is aligned with the plurality of secondary fluid pathways, the second end of the instrument is not aligned with the plurality of secondary fluid pathways, and the first end of the instrument is disposed in a second location.

2. The conveying device according to claim 1, characterized in that In response to rotation of the rotational element from the second position to the first position, the instrument is advanced distally through the port.

3. The conveying device according to claim 1, characterized in that The rotating element rotates from the first position to the second position in response to the rotating element rotating less than a full rotation.

4. The conveying device according to claim 1, characterized in that The rotating element is configured to rotate relative to the housing between the first position, the second position, and a third position, wherein, in response to the rotating element being in the third position, the second end of the instrument is aligned with the plurality of secondary fluid pathways, the channel is aligned with the plurality of secondary fluid pathways, and the first end of the instrument is disposed in a third location.

5. The conveying device according to claim 4, characterized in that In response to rotation of the rotational element from the third position to the first position, the instrument is advanced distally through the port.

6. The conveying device according to claim 4, characterized in that In response to the rotation of the rotation element being approximately one quarter of a full revolution, the rotation element rotates from the first position to the third position.

7. The conveying device according to claim 1, characterized in that The apparatus includes a tube.

8. The conveying device according to claim 1, characterized in that The connector includes a Luer adapter.

9. The conveying device according to claim 1, characterized in that The delivery device also includes an extension tube integrated into the port.

10. The conveying device according to claim 1, characterized in that The second end of the instrument is secured within the recess.

11. The conveying device according to claim 1, characterized in that The grooves extend inwardly from the circumference toward a central rotational axis of the rotating element.

12. A catheter system, characterized in that: The catheter system comprises: A catheter assembly, comprising: catheter adapters; and a catheter having a distal end, wherein the catheter extends distally from the catheter adapter; and a delivery device coupled to the catheter assembly, the delivery device comprising: a housing including a port; A connector, wherein the connector comprises: primary fluid paths; and a plurality of secondary fluid paths in fluid communication with the primary fluid path; a rotating element disposed within the housing and coupled to the connector, wherein the connector extends through the rotating element, wherein the rotating element comprises: a groove extending around at least a portion of the circumference of the rotating element; and Channels; and an instrument comprising a first end and a second end, wherein the instrument is disposed within the recess and between the rotating element and the housing, wherein the rotating element is configured to rotate relative to the housing between a first position and a second position, wherein, in response to the rotational element being in the first position, the second end of the instrument is aligned with the plurality of secondary fluid pathways, the passageway is not aligned with the plurality of secondary fluid pathways, and the first end of the instrument is disposed in a first location, wherein the first location is distal to the distal end of the catheter, wherein, in response to the rotational element being in the second position, the channel is aligned with the plurality of secondary fluid paths, the second end of the instrument is not aligned with the plurality of secondary fluid paths, and the first end of the instrument is disposed in a second location, wherein the second location is proximal to the distal end of the catheter.

13. The catheter system according to claim 12, wherein: The catheter system further includes an extension tube including a proximal end and a distal end, wherein the proximal end of the extension tube is integrated into the port, and wherein the distal end of the extension tube is integrated into the catheter adapter.

14. The catheter system according to claim 12, wherein: The apparatus includes a tube.

15. A delivery device for delivering a device through an intravenous catheter, characterized in that: The conveying device comprises: a housing comprising a first port, a second port, and a protrusion; a rotating element disposed in the housing, wherein the rotating element comprises: a groove extending around at least a portion of the circumference of the rotating element; an upper end, the upper end including a connector; lower end; an inner cavity extending through the upper end and the lower end; an upper diaphragm disposed within the inner cavity; a lower diaphragm disposed within the lumen, wherein, in response to connection of a medical device to the connector, the upper diaphragm is configured to move toward the lower diaphragm to allow fluid to flow around the upper diaphragm, and the instrument, the instrument comprising a first end and a second end, wherein the instrument is disposed within the recess and between the rotating element and the housing, wherein the rotating element is configured to rotate relative to the housing between a first position and a second position, wherein, in response to the rotation of the rotating element to the first position, the lower diaphragm contacts the protrusion and moves toward the opening, the lower diaphragm dividing the inner cavity into an upper chamber and a lower chamber sealed from the upper chamber, the upper chamber being in fluid communication with the second end of the instrument, the instrument extending through the first port, and the first end of the instrument being disposed in a first location, wherein the second port is in fluid communication with the lower chamber; wherein, in response to the rotation of the rotary element to the second position, the lower diaphragm moves away from the opening, the upper chamber, the lower chamber, and the second end of the instrument are in fluid communication, and the first end of the instrument is disposed in a second location.

16. The conveying device according to claim 15, characterized in that The delivery device further includes a spring disposed within the inner cavity, wherein the spring urges the upper diaphragm upward against the housing to prevent fluid from flowing around the upper diaphragm.

17. The conveying device according to claim 15, characterized in that The apparatus includes a tube.

18. The conveying device according to claim 15, characterized in that The second end of the instrument is secured within the recess.

19. The conveying device according to claim 15, characterized in that The delivery device further includes a passage disposed between a lower end of the rotating element and the housing, wherein the passage is in fluid communication with the lower chamber.

20. The conveying device according to claim 15, characterized in that The connector includes a Luer adapter.

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