Spring-loaded devices and systems for facilitating vascular access - Patent Application 20070122999

Abstract

A spring-loaded device for facilitating vascular access is provided. A catheter system may include a catheter assembly, which may include a catheter adapter. The catheter adapter may have a distal end, a proximal end, and a lumen extending through the distal end and the proximal end of the catheter adapter. The catheter assembly may include a catheter, which may extend distally from the distal end of the catheter adapter. The catheter system may include an instrument extending through a distal opening of the catheter. The instrument may include a coil spring.

Description

[Technical Field]

[0001] The present invention relates to a spring-loaded device for facilitating vascular access. [Background technology]

[0002] Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse normal saline, various medications, total parenteral nutrition, etc. Catheters may also be used to withdraw blood from a patient.

[0003] The catheter may include an over-the-needle peripheral intravenous ("IV") catheter, in which case the catheter may be mounted over an introducer needle with a sharpened distal tip. The catheter and introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle points upward, away from the patient's skin. The catheter and introducer needle are typically inserted through the skin at a shallow angle into the patient's vascular system.

[0004] To confirm proper placement of the introducer needle and / or catheter within the blood vessel, the clinician will typically check for "backflow" of blood in the backflow chamber of the catheter assembly. Once needle position is confirmed, the clinician may temporarily block flow through the vasculature and remove the needle, leaving the catheter in place for future blood draws or infusions. Summary of the Invention [Problem to be solved by the invention]

[0005] Using a catheter to withdraw or transfuse blood can be difficult for several reasons, especially when the catheter is left in the vascular system for more than a day. Leaving a catheter inserted in a patient for an extended period of time can make the catheter and vein susceptible to stenosis, collapse, kinking, or blockage by debris (e.g., fibrin, thrombus, platelet clumps), and the catheter tip can become attached to the vascular system. This can lead to poor infusion results. For this reason, catheters are often used to withdraw blood samples at the time of catheterization, but are rarely used to withdraw blood samples during the catheterization period. Therefore, when a blood sample is required, additional needle punctures are often required to gain venous access for blood collection, which can be painful for the patient and expensive in terms of materials. [Means for solving the problem]

[0006] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is provided only to illustrate one example technology area where some implementations described herein may be practiced.

[0007] The present disclosure generally relates to spring-loaded devices, systems, and methods for facilitating vascular access. In some embodiments, a spring-loaded device or system can include an instrument that can extend through a distal opening of a catheter. In some embodiments, the instrument can include a spring, such as a coil spring. In some embodiments, the coil spring can include a central guidewire extending therethrough or one or more eccentric guidewires extending therethrough. In some embodiments, the instrument can include a tube that can include a side hole and / or a closed distal tip. In some embodiments, the instrument can include a probe or a sensor.

[0008] In some embodiments, a spring-loaded device or system may facilitate blood withdrawal from a patient, fluid delivery to a patient, patient or device monitoring, or other clinical needs by utilizing an existing catheter placed within the patient's vasculature. In some embodiments, the spring-loaded device or system may reduce trauma to the vasculature, reduce blood withdrawal time, reduce the risk of hemolysis, and overcome thrombus or fibrin sheaths in or around the catheter that may prevent blood withdrawal. In some embodiments, the spring-loaded device or system may be used to extend the life of a catheter placed within the vasculature and may reduce the number of needle sticks. In some embodiments, the spring-loaded device or system may include a probe.

[0009] In some embodiments, the expansion set can be configured to couple to the vascular access device. In some embodiments, the expansion set can include a distal connector and a proximal connector. In some embodiments, the expansion set can include a housing, the housing can include a distal end coupled to the distal connector and a proximal end coupled to the proximal connector. In some embodiments, the expansion set can include a sleeve disposed within the housing and configured to move distally such that a distal end of the sleeve is located distal to the distal connector. In these embodiments, the sleeve can be configured to move distally in response to distal flushing of a liquid through the housing.

[0010] In some embodiments, the distal end of the instrument can be located distal to the distal end of the sleeve. In these and other embodiments, the instrument can be coupled to the sleeve. In some embodiments, the expansion set can include an instrument disposed within the sleeve. In some embodiments, the instrument can be configured to move distally such that the distal end of the instrument is located distal to the distal end of the sleeve. In these embodiments, the instrument can be configured to move distally in response to distal flushing of liquid through the housing.

[0011] In some embodiments, the distal connector may include an inner diameter. In some embodiments, the outer surface of the sleeve may include a feature. In some embodiments, the feature may include an outer diameter. In some embodiments, the outer diameter of the feature may be larger than the inner diameter of the distal connector to prevent the feature from moving distally through the distal connector. In some embodiments, the sleeve may include an inner diameter. In some embodiments, the proximal portion of the instrument may include an outer diameter. In some embodiments, the outer diameter of the proximal portion of the instrument may be larger than the inner diameter of the sleeve to prevent the proximal portion of the instrument from moving distally beyond the inner diameter of the sleeve.

[0012] In some embodiments, the pitch of the instrument may vary. In some embodiments, the pitch of the instrument may be uniform. In some embodiments, the outer diameter of the distal end of the instrument may be smaller than the outer diameter of the proximal portion of the instrument. In some embodiments, the sleeve may include a variable outer diameter. In some embodiments, the sleeve may include a tube. In some embodiments, the sleeve may include one or more side holes. In some embodiments, the sleeve may include one or more side holes and a closed distal tip.

[0013] In some embodiments, the vascular access device may include a catheter assembly. In some embodiments, the catheter system may include a catheter assembly, which may include a catheter adapter. In some embodiments, the catheter adapter may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter assembly may include a catheter, which may extend distally from the distal end of the catheter adapter. In some embodiments, the catheter may include a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter.

[0014] In some embodiments, the catheter system can include an instrument that can extend through a distal opening of the catheter. In some embodiments, the pitch of a portion of the instrument proximate the distal opening of the catheter can be smaller than the pitch of another portion of the instrument proximate the distal opening of the catheter. In some embodiments, the catheter system can include a sleeve that can extend through the instrument. In some embodiments, the sleeve can include an obturator that can block fluid flow through the center of the instrument to prevent the instrument from clogging with thrombi in response to insertion of the catheter into the patient's vasculature. In these and other embodiments, the outer surface of the sleeve can contact the inner surface of the instrument along the length of the instrument, preventing fluid flow between the instrument and the sleeve.

[0015] In some embodiments, the catheter system may include a connector coupled to the proximal end of the catheter adapter. In some embodiments, an instrument may be coupled to the connector and extend distally from the connector through the catheter. In some embodiments, the catheter assembly may include another expansion set. In some embodiments, the catheter adapter may include a side hole that may be coupled to the other expansion set. In some embodiments, the connector may be coupled to the other expansion set.

[0016] In some embodiments, another instrument may extend through the distal opening of the catheter. In some embodiments, the other instrument may include another coil spring. In some embodiments, the instrument and the other instrument may be wound together to limit the ability of thrombi to enter the catheter assembly during insertion of the catheter into the patient's vasculature. In some embodiments, the instrument and the other instrument may be concentric and include a central axis extending through the instrument and the other instrument. In some embodiments, the other instrument may be configured to rotate about the central axis such that the distal end of the other instrument is spaced apart from the distal end of the present instrument. For example, the other instrument may be configured to rotate about the central axis and advance distally relative to the instrument. As another example, the other instrument may be configured to rotate about the central axis and retract proximally relative to the instrument. In some embodiments, rotation of the other instrument about the central axis and movement of the other instrument distally or proximally relative to the instrument may open a fluid pathway through the instrument and the other instrument for blood collection.

[0017] In some embodiments, the straightening sleeve may be disposed within the catheter. In some embodiments, the sleeve may be disposed within the straightening sleeve. In some embodiments, the sleeve may be configured to bend into the instrument in response to removal of the distal end of the sleeve from the straightening sleeve. In some embodiments, the sleeve may be configured to advance distally relative to the straightening tube. In some embodiments, the sleeve may automatically bend into the instrument in response to distal advancement of the sleeve over the distal end of the straightening tube. In some embodiments, the straightening tube may be configured to retract proximally relative to the sleeve. In some embodiments, the sleeve may automatically bend into the instrument in response to proximal retraction of the straightening tube relative to the sleeve. In some embodiments, the sleeve may bend into the instrument in response to activation by heat or moisture.

[0018] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive, as claimed. It is to be understood that the various embodiments are not limited to the arrangement and instrumentality shown in the drawings. It is also to be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the present disclosure, unless so claimed. Accordingly, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0019] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0020] [Figure 1A] 1 is a cross-sectional view of an exemplary expansion set, according to some embodiments. [Figure 1B] FIG. 1B is an enlarged cross-sectional view of the distal end of the expansion set of FIG. 1A, according to some embodiments. [Figure 1C] FIG. 1B is a cross-sectional view of an exemplary catheter system, showing an exemplary sleeve and an exemplary device of the expansion set of FIG. 1A positioned in a distal position in response to flushing of liquid distally through the housing, according to some embodiments. [Figure 1D] FIG. 1D is an enlarged cross-sectional view of the distal end of the catheter system of FIG. 1C showing the sleeve and instrument in a distal position, according to some embodiments. [Figure 1E] FIG. 1D is an enlarged cross-sectional view of a portion of the catheter system of FIG. 1C showing the sleeve in a distal position and exemplary features on the outer surface of the sleeve, according to some embodiments. [Figure 2A] FIG. 10 is a cross-sectional view of another expansion set, according to some embodiments. [Figure 2B]2B is a cross-sectional view of an exemplary catheter system showing an exemplary sleeve and an exemplary device of the expansion set of FIG. 2A positioned in a distal position in response to flushing of liquid distally through the housing, according to some embodiments. [Figure 2C] FIG. 2C is an enlarged cross-sectional view of the distal end of the catheter system of FIG. 2B showing the sleeve and device in a distal position, according to some embodiments. [Figure 2D] 12A-12C are top perspective views of another exemplary sleeve and another exemplary device, according to some embodiments. [Figure 3A] 1 is a cross-sectional view of another exemplary catheter system showing an example of a heat-activated or moisture-activated guidewire, according to some embodiments. [Figure 3B] FIG. 3B is a cross-sectional view of the distal end of the catheter system of FIG. 3A showing the heat-activated or moisture-activated guidewire before it is heat-activated or moisture-activated. [Figure 3C] FIG. 3B is a cross-sectional view of the distal end of the catheter system of FIG. 3A showing the heat-activated or moisture-activated guidewire after heat-activated or moisture-activated. [Figure 3D] 1A-1C are cross-sectional views of an exemplary orthodontic sleeve and an exemplary guidewire, according to some embodiments. [Figure 3E] 3D is a cross-sectional view of the guidewire of FIG. 3D advanced distally or the corrective sleeve of FIG. 3D retracted, according to some embodiments. [Figure 4A] FIG. 1 is a cross-sectional view of another exemplary catheter system, according to some embodiments. [Figure 4B] FIG. 4B is an enlarged cross-sectional view of the distal end of the catheter system of FIG. 4A, according to some embodiments. [Figure 4C] FIG. 4B is a cross-sectional view of the catheter system of FIG. 4A showing an exemplary guidewire removed from the catheter system, according to some embodiments. [Figure 5A] FIG. 1 is a cross-sectional view of another catheter system, according to some embodiments. [Figure 5B] FIG. 1 is an enlarged view of a portion of one instrument and a portion of another instrument. [Figure 5C] FIG. 10 is a close-up view of another instrument advanced distally relative to the instrument, according to some embodiments. [Figure 6A] FIG. 1 is a top perspective view of the distal end of another exemplary catheter system, according to some embodiments. [Figure 6B] FIG. 6B is a cross-sectional view of the distal end of the catheter system of FIG. 6A, according to some embodiments. [Figure 7A] FIG. 1 illustrates a top perspective view of an exemplary device configured to extend through a catheter, according to some embodiments. [Figure 7B] FIG. 7B is a cross-sectional view of the device of FIG. 7A coupled to another exemplary catheter system, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0021] 1A-1B, in some embodiments, an expansion set 10 can be configured to couple to a vascular access device. In some embodiments, the expansion set 10 can include a distal connector 12 and a proximal connector 14. In some embodiments, the expansion set 10 can include a housing 16 having a distal end 18 coupled to the distal connector 12 and a proximal end 20 coupled to the proximal connector 14. In some embodiments, the expansion set 10 can include a sleeve 22 disposed within the housing 16 and configured to move distally so that a distal end 24 of the sleeve 22 is distal to the distal connector 12. In these embodiments, the sleeve 22 can be configured to move distally in response to the distal flushing of liquid or air through the housing 16. In some embodiments, a vent can allow air to escape from the expansion set 10.

[0022] In some embodiments, the sleeve 22 can include a tube, which can include an open distal end, as shown, for example, in FIGS. 1A-1B. In some embodiments, the sleeve 22 can include a tube, which can include a side hole and / or a closed distal tip. In some embodiments, the sleeve 22 can include a probe or a sensor. In some embodiments, the expansion set 10 can include an instrument 26 disposed within the sleeve 22. In some embodiments, the instrument 26 can include a spring, such as, for example, a coil spring. In some embodiments, the coil spring can be composed of a metal or another suitable material. In some embodiments, the coil spring can include a central guidewire extending therethrough or one or more eccentric guidewires extending therethrough. In some embodiments, the instrument 26 can include a tube, which can include a side hole and / or a closed distal tip. In some embodiments, the instrument 26 can include a probe or a sensor.

[0023] In some embodiments, the instrument 26 may be configured to move distally to position the distal end 28 of the instrument 26 distally of the distal end 24 of the sleeve 22. In these embodiments, the instrument 26 may be configured to move distally in response to the distal flushing of a liquid through the housing 16. In some embodiments, the proximal connector 14 may be coupled to a needleless connector 30.

[0024] 1C , in some embodiments, an infusion device 32, such as a syringe, may be coupled to the proximal connector 14. In some embodiments, the infusion device 32 may be directly coupled to the proximal connector 14. In other embodiments, the needleless connector 30 may be disposed between the infusion device 32 and the proximal connector 14. In some embodiments, the needleless connector 30 may be coupled to the infusion device 32. In some embodiments, the infusion device 32 may be activated (e.g., by depressing a plunger on a syringe) to cause fluid within the infusion device 32 to flow distally through the housing 16 and / or into a catheter assembly 34 coupled to the distal connector 12.

[0025] In some embodiments, the catheter system 36 may include a catheter assembly 34 and an expansion set 10. In some embodiments, the catheter assembly 34 may include a catheter adapter 38. In some embodiments, the catheter adapter 38 may include a distal end 40, a proximal end 42, and a lumen 44 extending through the distal end 40 of the catheter adapter 38 and the proximal end 42 of the catheter adapter 38. In some embodiments, the catheter assembly 34 may include a catheter 46 that may extend distally from the distal end 40 of the catheter adapter 38. In some embodiments, the catheter 46 may include a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter.

[0026] In some embodiments, the catheter assembly 34 may include another dilator set 48, which may be integrated with the catheter adapter 38. In some embodiments, the other dilator set 48 may include a dilator tube 50, which may be integrated with a side hole 52 of the catheter adapter 38 disposed between the distal end 40 and the proximal end 42. In some embodiments, the adapter 54 may be coupled to the proximal end of the dilator tube 50. In some embodiments, the distal connector 12 may be coupled to the adapter 54. In some embodiments, the distal connector 12 may be coupled to the proximal end 20 of the catheter adapter 38, and the sleeve 22 may be disposed generally linearly within the catheter adapter 38.

[0027] 1D-1E, in some embodiments, the distal connector 12 and / or the housing 16 can include an inner diameter 56. In some embodiments, the housing 16 can be rigid, semi-rigid, or flexible. In some embodiments, the outer surface of the sleeve 22 can include a feature 58. In some embodiments, the feature 58 can be integral or monolithically formed with the sleeve 22 as a single unit. In some embodiments, the feature 58 can be a separate component from the sleeve 22 and coupled to the sleeve 22. In some embodiments, the feature 58 can be wedge-shaped or another suitable shape. In some embodiments, the sleeve 22 can be retracted using a retraction mechanism that sandwiches the sleeve 22 and the feature 58. In some embodiments, the retraction mechanism can be disposed on the housing 16. Retraction mechanisms are further described in U.S. Patent Application No. 17 / 146,400, filed January 11, 2021, entitled "Plunger-Type Delivery Device for Facilitating Vascular Access," which is incorporated herein by reference in its entirety.

[0028] In some embodiments, the functional portion 58 may include an outer diameter 60. In some embodiments, the outer diameter 60 of the functional portion 58 may be larger than the inner diameter 56 to prevent the functional portion 58 from moving distally through the distal connector 12. In some embodiments, the sleeve 22 may include an inner diameter 62. In some embodiments, the proximal portion of the instrument 26 may include an outer diameter 64. In some embodiments, the outer diameter 64 of the proximal portion of the instrument 26 may be larger than the inner diameter 62 of the sleeve 22 to prevent the proximal portion of the instrument 26 from moving distally beyond the inner diameter 62 of the sleeve 22.

[0029] In some embodiments, in response to actuation or flushing of the infusion device 32, the sleeve 22 and the instrument 26 may be moved from a proximal position, as illustrated in FIGS. 1D-1E , to a distal position. In some embodiments, in response to the sleeve 22 and the instrument 26 being in the distal position, the sleeve 22 may be wedged within the distal connector 12 with an interference fit, since the outer diameter 60 is larger than the inner diameter 56, and / or the instrument 26 may be wedged within the distal end 24 of the sleeve 22 with an interference fit, since the outer diameter 64 is larger than the inner diameter 62. In some embodiments, in response to the sleeve 22 and the instrument 26 being in the distal position, the sleeve 22 and the instrument 26 may extend distally beyond the distal end 65 of the catheter 46. In some embodiments, the distal end 28 of the instrument 26 may extend between 0 and about 80 mm beyond the distal end of the catheter 46. In some embodiments, the distal end 28 of the device 26 may extend more than 80 mm beyond the distal end of the catheter 46. In some embodiments, the outer diameter 66 of the distal end 28 of the device 26 may be smaller than the outer diameter 64 of the proximal portion of the device 26.

[0030] 1C-1E, in some embodiments, the instrument 26 may form a fluid pathway to allow blood to enter the catheter 46 and the catheter assembly 34. In some embodiments, the infusion device 32 may function as a blood collection device (e.g., by retracting a plunger), or any other suitable blood collection device (e.g., a VACUTAINER® or VACUTAINER® LUER-LOK™ available from Becton Dickinson and Company, Franklin Lakes, New Jersey) may be coupled to the expansion set 10 to draw blood from the patient. In some embodiments, the sleeve 22 may be soft, which may reduce the likelihood of the sleeve 22 damaging the vasculature. In some embodiments, the durometer of the sleeve 22 may be less than the durometer of the catheter 46. In some embodiments, the sleeve 22 forms an isolated or closed fluid pathway for blood flow, reducing the risk of blood contamination due to drug adsorption in the catheter assembly 34. In some embodiments, the catheter 46 may function as a fluid pathway in addition to or instead of the sleeve 22. In some embodiments, the sleeve 22 may extend through the catheter 46 and the catheter adapter 38.

[0031] In some embodiments, the pitch of the fixture 26 may vary. In some embodiments, the fixture 26 may include a narrow pitch proximate the distal opening 68 of the sleeve 22 and / or adjacent the distal end of the catheter 46. In some embodiments, the narrow pitch may block blockages caused by fibrin sheaths, thrombi, or venous walls under vacuum pressure when the blood sampling device is activated. In some embodiments, the narrow pitch may prevent the catheter 46 from collapsing under vacuum pressure when the blood sampling device is activated. In some embodiments, the pitch of the fixture 26 may be uniform. In some embodiments, the fixture 26 may include a more open pitch proximal to the narrow pitch, which may promote increased blood flow and blood flow velocity compared to a closed sleeve or a narrow pitch.

[0032] In some embodiments, the device 26 may be coupled to a guidewire (not shown), which may extend through the device 26. In some embodiments, the distal end 28 of the device 26 may be rounded or curved to prevent trauma to the vein wall.

[0033] 2A-2D , an expansion set 70 is illustrated, according to some embodiments. In some embodiments, the expansion set 70 may be similar or identical to the expansion set 10 in one or more features and / or operation. In some embodiments, the distal end 28 of the instrument 26 may be located distal to the distal end 24 of the sleeve 22. In these and other embodiments, the instrument 26 may be coupled to the sleeve 22. In some embodiments, the instrument 26 may be coupled to the sleeve 22 in any suitable manner, such as by embedding, bonding, welding, adhesives, solvents, or an interference fit. In some embodiments, the instrument 26 may be wedged into the distal end 24 of the sleeve 22 with an interference fit because the outer diameter 64 is larger than the inner diameter 62. In some embodiments, the instrument 26 may be wedged into the distal end 24 of the sleeve 22 with an interference fit without flashing. In some embodiments, a guidewire (see, for example, guidewire 84 in FIGS. 6A-6B or guidewire 84 in FIGS. 4A-4C) may be coupled to and / or extend through device 26.

[0034] As shown in FIG. 2D , in some embodiments, sleeve 22 can include a variable outer diameter and a corresponding variable inner diameter. In some embodiments, the variable outer diameter and the corresponding variable inner diameter can facilitate greater blood flow through sleeve 22 in response to sleeve 22 being in a distal position. In some embodiments, the outer diameter of sleeve 22 can increase in response to an increase in the diameter of the interior geometry of catheter assembly 34. In some embodiments, device 26 can include two narrow pitch sections and a more open pitch section between the two narrow pitch sections.

[0035] 6A-6B, in some embodiments, sleeve 22 may include one or more side holes 72, which may facilitate blood withdrawal in the fluid pathway. In some embodiments, a guidewire 84 may extend through device 26 to provide rigidity and reduce the likelihood of collapse of catheter 46. As previously mentioned, in some embodiments, distal end 28 of device 26 may be rounded or curved to prevent trauma to the wall of the vein. In some embodiments, the device 26 and / or sleeve 22 may include a staged deployment, as described, for example, in U.S. patent application Ser. No. 16 / 037,246, filed July 17, 2018, entitled "Expanding Housing, Sleeve, or Intravascular Catheter," U.S. patent application Ser. No. 16 / 388,650, filed April 18, 2019, entitled "Delivery Device for Device Having Rotating Elements," U.S. patent application Ser. No. 16 / 037,319, filed July 17, 2018, entitled "Catheter Having Multiple Diameters and Related Devices and Methods," U.S. patent application Ser. No. 16 / 037,319, filed July 3, 2019, entitled "Delivery Device for Vascular Access Device," and U.S. patent application Ser. No. 16 / 502,541, entitled "Syringe-Type Delivery Device for Vascular Access Devices," filed November 21, 2019; U.S. patent application Ser. No. 16 / 691,217, entitled "Catheter Delivery Device and Related Systems and Methods," filed January 14, 2020; and U.S. patent application Ser. No. 16 / 838,831, entitled "Vascular Access Devices Having Fluid-Permeable Structures and Related Devices and Methods," filed April 2, 2020, each of which is incorporated by reference in its entirety.

[0036] 3A-3C, in some embodiments, the catheter system 36 can include a particular guidewire 74 that can bend in response to heat or moisture activation to form the device 26. FIG. 3B is a cross-sectional view of the distal end of the catheter system of FIG. 3A, showing the heat- or moisture-activated guidewire prior to heat or moisture activation, according to some embodiments. In some embodiments, the guidewire 74 can be inserted through the catheter assembly 34 to reduce blockages caused by fibrin sheaths or thrombi. In some embodiments, the guidewire 74 and / or the device 26 can be constructed of a shape memory polymer or alloy.

[0037] 3D-3E , in some embodiments, the straightening sleeve 76 may be disposed within the catheter 46. In some embodiments, the guidewire 78 may be disposed within the straightening sleeve 76, and the straightening sleeve 76 may extend through the catheter assembly 34. In some embodiments, in response to removal of the distal end 80 of the guidewire 78 from the straightening sleeve 76, the guidewire 78 may be configured to bend to form the instrument 26. In some embodiments, the guidewire 78 may be configured to be advanced distally relative to the straightening sleeve 76 for blood withdrawal. In some embodiments, in response to the guidewire 78 advancing distally beyond the distal end of the straightening sleeve 76, the guidewire 78 may automatically bend to form the instrument. In some embodiments, the straightening sleeve 76 may be configured to be retracted proximally relative to the guidewire 78 for blood withdrawal. In some embodiments, in response to the straightening sleeve 76 being retracted proximally relative to the guidewire 78, the guidewire 78 may automatically bend to form the instrument 26.

[0038] 4A-4C , in some embodiments, the catheter system 36 may include the instrument 26, which may extend through a distal opening 82 of the catheter 46. In some embodiments, the pitch of a portion of the instrument 26 proximate the distal opening 82 of the catheter 46 may be smaller than the pitch of another portion of the instrument 26 proximate the distal opening 82 of the catheter 46. In some embodiments, the catheter system 36 may include a guidewire 84, which may extend through the instrument 26. In some embodiments, the guidewire 84 may include an obstruction, such as a rounded nose, that may block fluid flow through the center of the instrument 26 to prevent clogging of the instrument 26 with thrombi in response to insertion of the catheter 46 into the patient's vasculature. In these and other embodiments, the outer surface of the guidewire 84 may contact the inner surface of the instrument 26 along all or a portion of the length of the instrument 26, preventing fluid from flowing between the instrument 26 and the guidewire 84.

[0039] In some embodiments, the catheter system 36 may include a connector 86 coupled to the catheter assembly 34. For example, the connector 86 may be coupled to the proximal end 42 of the adapter 54 or the catheter adapter 38. In some embodiments, the instrument 26 may be coupled to the connector 86 and extend distally from the connector 86 through the catheter 46. In some embodiments, the guidewire 84 may be coupled to another connector 88, which may be coupled to the connector 86. In some embodiments, the guidewire 84 may be detachable from the catheter system 36. In some embodiments, the guidewire 84 may be detachable from the catheter system 36 for blood withdrawal or infusion.

[0040] 5A-5C, in some embodiments, another device 90 may extend through the distal opening 82 of the catheter 46. In some embodiments, the device 26 and the other device 90 may be wound together to limit the ability of thrombus or other obstructions to enter the catheter assembly 34 during insertion of the catheter 46 into the patient's vasculature. In some embodiments, the device 26 and the other device 90 may be concentric and may include a central axis extending through the device 26 and the other device 90.

[0041] In some embodiments, the other instrument 26 can be configured to rotate about a central axis such that the distal end 92 of the other instrument 90 and the distal end 28 of the present instrument 26 are spaced apart. For example, the other instrument 90 can be configured to rotate about a central axis and advance distally relative to the instrument 26. In some embodiments, the instrument 26 and the other instrument 90 can be nested such that they contact each other and wrap around one another. As another example, the other instrument 90 can be configured to rotate about a central axis and retract proximally relative to the instrument 26. In some embodiments, rotation of the other instrument 90 about its central axis and movement of the other instrument 90 distally or proximally relative to the instrument 26 can open a fluid pathway through the instrument 26 and the other instrument 90 for blood withdrawal or transfusion, as shown in FIG. 5C , for example.

[0042] 7A-7B, in some embodiments, a connector 86 may be coupled to the proximal end 42 of the catheter adapter 38. In some embodiments, the device 26 may be coupled to the connector 86 and may extend distally from the connector 86 through the catheter 46 in a generally straight line. In some embodiments, the device 26 may include a coil spring. In some embodiments, the coil spring may include a central guidewire extending therethrough or one or more eccentric guidewires extending therethrough. In some embodiments, the device 26 may include a tube, which may include a side hole and / or a closed distal tip. In some embodiments, the device 26 may include a probe or a sensor.

[0043] All examples and conditional statements described herein are intended for educational purposes to aid the reader in understanding the present disclosure and the concepts provided by the inventors to advance the art, and are not to be construed as being limited to such specifically described examples and conditions. Although embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations are possible herein without departing from the spirit and scope of the present disclosure. [Explanation of symbols]

[0044] 10 Expansion Sets 12 Distal Connector 14 Proximal Connector 16 Case 22 sleeve 26 Equipment 30 Needleless Connector 32 Infusion Devices 34 Catheter Assembly 36 Catheter System 38 Catheter adapter

Claims

1. 1. An expansion set for coupling to a vascular access device, the expansion set comprising: a distal connector; a proximal connector; a housing including a distal end coupled to the distal connector and a proximal end coupled to the proximal connector; a tube disposed within the housing and configured to move distally so that a distal end of the tube is distal to the distal connector; a coil spring disposed in connection with the tube, An expansion set, wherein the distal end of the coil spring is distal to the distal end of the tube, or the coil spring is configured to move distally so that the distal end of the coil spring is distal to the distal end of the tube.

2. The expansion set of claim 1 , wherein the distal end of the coil spring is distal to the distal end of the tube.

3. The expansion set of claim 1 , wherein the coil spring is configured to move distally such that the distal end of the coil spring is distal to the distal end of the tube.

4. 2. The expansion set of claim 1, wherein the distal connector has an inner diameter, the outer surface of the tube has a feature, the feature having an outer diameter, the outer diameter of the feature being larger than the inner diameter to prevent the feature from moving distally through the distal connector.

5. 2. The expansion set of claim 1, wherein the coil spring is configured to move distally such that the distal end of the coil spring is distal to the distal end of the tube, the tube having an inner diameter and a proximal portion of the coil spring having an outer diameter, the outer diameter being larger than the inner diameter to prevent the proximal portion of the coil spring from moving distally beyond the inner diameter of the tube.

6. The expansion set of claim 1 , wherein the coil springs vary in pitch.

7. The expansion set of claim 1 , wherein the coil springs have a uniform pitch.

8. The expansion set of claim 1 , wherein the outer diameter of the distal end of the coil spring is smaller than the outer diameter of the proximal portion of the coil spring.

9. The expansion set of claim 1 , wherein the tube has a variable outer diameter.

10. The expansion set of claim 1 , wherein the tube comprises a plurality of side holes.

11. a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; and a catheter extending distally from the distal end of the catheter adapter; and A catheter system comprising: a coil spring coupled to the catheter and extending through a distal opening of the catheter.

12. 12. The catheter assembly of claim 11, wherein a pitch of a portion of the coil spring proximate the distal opening of the catheter is smaller than a pitch of another portion of the coil spring proximate the distal opening of the catheter.

13. The catheter system of claim 11 further comprising a guidewire extending through the coil spring.

14. 14. The catheter assembly of claim 13, wherein the guidewire includes an obturator, the outer surface of the obturator contacting the inner surface of the coil spring along the length of the coil spring.

15. 12. The catheter system of claim 11, further comprising another coil spring extending through the distal opening of the catheter, the other coil spring configured to rotate relative to the coil spring for distal advancement.

16. 12. The catheter system of claim 11, further comprising a connector coupled to the proximal end of the catheter adapter, the coil spring coupled to the connector and extending distally from the connector through the catheter.

17. 12. The catheter system of claim 11, wherein the catheter assembly further comprises an expansion set, the catheter adapter further comprises a side hole coupled to the expansion set, and a connector coupled to the expansion set, and the coil spring is coupled to the connector and extends distally from the connector through the catheter.

18. a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; a catheter extending distally from the distal end of the catheter adapter; and a correction tube disposed within the catheter; a guide wire coupled and disposed within the orthodontic tube; A catheter system wherein the guidewire automatically bends to form a coil spring in response to the distal end of the guidewire being removed from the straightening tube.

19. 20. The catheter system of claim 18, wherein the guidewire is configured to be advanced distally relative to the straightening tube, and wherein the guidewire automatically bends to form the coil spring in response to the guidewire being advanced distally beyond the distal end of the straightening tube.

20. 20. The catheter system of claim 18, wherein the straightening tube is configured to retract proximally relative to the guidewire, and the guidewire is configured to bend to form the coil spring in response to the straightening tube retracting proximally relative to the guidewire.

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