Catheter System with Remote Instrument Delivery

Abstract

In some embodiments, a catheter system can include a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. In some embodiments, the catheter system can further include a catheter extending distally from the distal end of the catheter adapter, an extension tube, and a connector coupled to the proximal end of the extension tube. In some embodiments, the distal end of the extension tube can be coupled to the proximal end of the catheter adapter. In some embodiments, the connector, the extension tube, the lumen, and the catheter can form a straight path for delivering an instrument to the catheter system. In some embodiments, an extension kit for a catheter assembly can include an extension tube, a connector coupled to the proximal end of the extension tube, and another connector coupled to the distal end of the extension tube.

Description

[0001] Division Explanation

[0002] This invention patent application is a divisional patent application. The original application of this divisional patent application (i.e., Parent case, matter Firm docket number IIM206100 ), is an invention patent application with an international filing date of April 17, 2019, an international application number of PCT / US2019 / 027835, a Chinese national application number of 201980034270.5, and an invention title of "Catheter System with Remote Device Delivery". Background Art

[0003] Infusion therapy is a common healthcare procedure that can be facilitated through a vascular access device. Hospitalized, home care, and other patients receive fluids, medications, and blood products via a vascular access device inserted into the vascular system. Blood drawing is another common healthcare procedure that can be facilitated through a vascular access device.

[0004] Vascular access devices can access a patient's peripheral or central vascular system. Vascular access devices can be left in place for short periods (days), medium periods (weeks), or long periods (months to years). Vascular access devices can be used for continuous infusion therapy or for intermittent therapy.

[0005] A common type of vascular access device is a peripheral intravenous catheter (PIVC) with a stylet. As the name implies, a "stylet" PIVC can be mounted on an introducer needle with a sharp distal end. The sharp distal end can be used to pierce the patient's skin and vascular system. The PIVC can be inserted into the vascular system after the needle has pierced the vascular system. The needle and PIVC are typically inserted into the patient's vascular system at a shallow angle through the skin, with the bevel of the needle away from the patient's skin. Once the placement of the needle within the vascular system has been confirmed, the clinician can temporarily occlude the flow within the vascular system and withdraw the needle, leaving the PIVC in place for future fluid infusion and / or blood drawing.

[0006] Currently, there may be several limitations to the use of PIVCs for fluid infusion or blood extraction. Over time, PIVCs can become narrowed, collapsed, or blocked, resulting in PIVC failure. In addition, due to concerns about sample quality, blood drawn from a PIVC may often need to be discarded. In addition, using a PIVC to draw blood can be slow and somewhat inefficient, especially when the patient is diagnosed with difficult intravenous access or veins that are not easily accessible to the clinician.

[0007] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or operate only in environments such as those described above. Instead, this background is provided only to illustrate an exemplary technical field in which some of the embodiments described herein may be practiced. Summary of the Invention

[0008] The present disclosure generally relates to vascular access systems, devices, and related methods. More specifically, in some embodiments, the present disclosure relates to catheter systems, devices, and related methods that facilitate the delivery of an instrument into an indwelling catheter and / or the vasculature of a patient. In some embodiments, the instrument can include a guide wire, a probe having a sensor, a tube for fluid infusion or blood withdrawal, a light tube for disinfection, or another suitable instrument. In some embodiments, the delivery of the instrument can be stabilized via one or more stabilizing platforms or features. In some embodiments, the delivery of the instrument can occur along a straight path, which can facilitate the support of the instrument and / or prevent the instrument from bending. In some embodiments, the process of inserting the instrument into the catheter can be performed remotely, which can reduce interference with the catheter insertion site in the patient's skin.

[0009] In some embodiments, the instrument can include a tube, and the act of delivering the instrument into the catheter and / or the vasculature of the patient can allow a user to withdraw a blood sample or infuse fluid through the catheter when the catheter no longer has the function or effect of collecting blood (e.g., due to debris accumulation or catheter collapse at the distal end of the catheter). Thus, in some embodiments, the act of delivering the instrument into the catheter can reduce the number of needle sticks experienced by the patient, as the second catheter can be replaced less frequently.

[0010] In some embodiments, the catheter system can include a catheter adapter having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. In some embodiments, the proximal end of the catheter adapter can be axially aligned with the distal end of the catheter adapter. In some embodiments, the catheter system can include a catheter that extends distally from the distal end of the catheter adapter. In some embodiments, the catheter can include a PIVC.

[0011] In some embodiments, the catheter system can include an extension tube having a distal end and a proximal end. In some embodiments, the distal end of the extension tube can be coupled to the proximal end of the catheter adapter. In some embodiments, the catheter system can include a connector coupled to the proximal end of the extension tube. In some embodiments, the connector, the extension tube, the lumen, and the catheter can form a straight or linear path for delivering the instrument into the catheter system. In some embodiments, the instrument can be delivered through the catheter system into the vasculature of the patient.

[0012] In some embodiments, the distal end of the extension tube may be coupled to the proximal end of the catheter adapter via a Luer adapter. In some embodiments, the Luer adapter may be selectively coupled to a corresponding Luer adapter disposed on the proximal end of the catheter adapter. In some embodiments, the distal end of the extension tube may be fixedly coupled to the proximal end of the catheter adapter. In some embodiments, the extension tube may allow for remote delivery of an instrument, which may reduce interference with the catheter insertion site.

[0013] In some embodiments, the extension tube may be rigid, semi-rigid, or flexible. In some embodiments, the gauge hardness of the extension tube may be between 70 Shore A and 95 Shore A (including 70 Shore A and 95 Shore A). In some embodiments, the extension tube may be a first extension tube. In some embodiments, the catheter system may include a second extension tube coupled to the first extension tube. In some embodiments, the second extension tube may be disposed at an angle relative to the first extension tube. In some embodiments, the hardness of the first extension tube may be greater than the hardness of the second extension tube.

[0014] In some embodiments, the connector may include a Y-shaped adapter that may include a first port and a second port. In some embodiments, the first port may be configured to couple to an instrument delivery device. In some embodiments, the second extension tube may extend from the second port of the Y-shaped adapter. In some embodiments, the connector may include a blood control diaphragm.

[0015] In some embodiments, the catheter system may include at least one stabilization feature that may be disposed between the connector and the distal end of the extension tube. In some embodiments, the extension tube may extend through the stabilization feature. In some embodiments, the stabilization feature may be fixed relative to the extension tube. In some embodiments, the stabilization feature may rotate about the longitudinal axis of the extension tube on the extension tube.

[0016] In some embodiments, the stabilization feature may include one or more platforms that may include an adhesive layer. In some embodiments, the adhesive layer may be configured to contact the patient's skin. In some embodiments, the catheter system may include a fixation fabric that may be coupled to the stabilization feature. In some embodiments, the fabric may extend outwardly from the stabilization feature. In some embodiments, the fabric may include an adhesive layer that may be configured to contact the patient's skin.

[0017] In some embodiments, the catheter assembly may include a catheter adapter and a catheter. In some embodiments, an extension kit for the catheter assembly may include an extension tube, a connector coupled to the proximal end of the extension tube, and another connector coupled to the distal end of the extension tube. The extension tube, the connector, and the other connector may form at least a portion of a straight path. In some embodiments, the straight path may be aligned with the longitudinal axis of the catheter assembly.

[0018] It should be understood that the foregoing summary description and the following detailed description are illustrative and explanatory, and not restrictive of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the drawings. It should also be understood that these embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless otherwise required. Accordingly, the following detailed description is not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Exemplary embodiments will be described and explained with additional specific details by using the drawings, in which:

[0020] Figure 1A is a top perspective view of an exemplary catheter system according to some embodiments;

[0021] Figure 1B is according to some embodiments Figure 1A of a cross-sectional view of the catheter system;

[0022] Figure 1C is according to some embodiments of the Figure 1A catheter system coupled to an exemplary device delivery device;

[0023] Figure 1D is according to some embodiments Figure 1A of a top perspective view of the catheter system, showing exemplary stabilization features;

[0024] Figure 1E is according to some embodiments Figure 1A of a bottom view of a portion of the catheter system, showing the stabilization features;

[0025] Figure 1F is according to some embodiments Figure 1A of a top perspective view of the catheter system, showing exemplary fixation fabric;

[0026] Figure 1G is according to some embodiments Figure 1A of a bottom view of a portion of the catheter system, showing the fixation fabric;

[0027] Figure 1H is according to some embodiments Figure 1A of a top perspective view of the catheter system, showing an exemplary dressing;

[0028] Figure 1I is according to some embodiments Figure 1A of a top perspective view of the catheter system, showing an exemplary connector having a distally directed port;

[0029] Figure 1J Cross-sectional view of an exemplary connector coupled to the proximal end of an exemplary extension tube, according to some embodiments;

[0030] Figure 2A According to some embodiments Figure 1A Upper perspective view of a catheter system, according to some embodiments, showing another exemplary stabilization feature;

[0031] Figure 2B According to some embodiments Figure 1A Bottom view of a portion of a catheter system, according to some embodiments, showing other stabilization features;

[0032] Figure 2C According to some embodiments Figure 1A Upper perspective view of a catheter system, according to some embodiments, showing another exemplary stabilization feature;

[0033] Figure 2D According to some embodiments Figure 1A Upper perspective view of a catheter system, according to some embodiments, showing Figure 2C a stabilization feature;

[0034] Figure 2E According to some embodiments Figure 2C Upper perspective view of a stabilization feature, according to some embodiments;

[0035] Figure 3A Upper perspective view of another catheter system, according to some embodiments, showing an exemplary connector having an exemplary diaphragm and an exemplary diaphragm actuator;

[0036] Figure 3B According to some embodiments Figure 3A Upper perspective view of a catheter system, according to some embodiments, having an exemplary clip and no diaphragm and actuator;

[0037] Figure 3C According to some embodiments Figure 3A Cross-sectional view of a catheter system, according to some embodiments, having a clip and no diaphragm and actuator; and

[0038] Figure 3D Upper perspective view of an exemplary needle shield mechanism, according to some embodiments. DETAILED DESCRIPTION

[0039] Generally, the present disclosure relates to vascular access systems, devices, and related methods. More specifically, in some embodiments, the present disclosure relates to catheter systems, devices, and related methods for facilitating the delivery of instruments into a particular catheter system and / or vascular system of a patient.

[0040] Now referring to Figures 1A - 1B, in some embodiments, the catheter system 10 may include a catheter adapter 12 having a distal end 14, a proximal end 16 axially aligned with the distal end 14, and a lumen 18 extending between the distal end 14 and the proximal end 16. In some embodiments, the catheter system 10 may include a catheter 20 that may extend distally from the distal end 14 of the catheter adapter 12. In some embodiments, the catheter assembly 22 may include the catheter adapter 12 and the catheter 20. In some embodiments, the catheter 20 may include a PIVC.

[0041] In some embodiments, the catheter system 10 may include an extension tube 24 that may include a distal end 26 and a proximal end 28. In some embodiments, the catheter system 10 may include a connector 30 coupled to the proximal end 28 of the extension tube 24. In some embodiments, the connector 30 may be configured to connect an instrument delivery device to the catheter system 10. In some embodiments, the connector 30 may selectively couple the instrument delivery device to the catheter system 10 such that the instrument delivery device may be removed from the catheter system 10. In some embodiments, the connector 30 may include a Luer adapter, such as a male Luer adapter or a female Luer adapter, or any other suitable connector. In some embodiments, the connector 30 may be a Luer-activated needleless connector or a non-Luer-activated needleless connector. In some embodiments, the connector 30 may include a SMARTSITE TM needleless connector available from Becton, Dickinson and Company, a Q-SYTE TM Luer-activated crack septum available from Baxter, an INTERLINK TM needleless system or another similar connector.

[0042] In some embodiments, the distal end 26 of the extension tube 24 may be coupled to the proximal end 16 of the catheter adapter 12. In some embodiments, another connector 34 may be configured to couple the distal end 26 of the extension tube 24 to the proximal end 16 of the catheter adapter 12. In some embodiments, the connector 34 may selectively or fixedly couple the distal end 26 of the extension tube 24 to the proximal end of the catheter adapter 12.

[0043] In some embodiments, the connector 34 may include a Luer adapter, such as a male Luer adapter or a female Luer adapter, or any other suitable connector. In some embodiments, the Luer adapter may include a rotating collar Luer lock. For example, the Luer adapter may include a freely rotating collar with threads and may be locked by rotating the collar.

[0044] In some embodiments, the catheter adapter 12 can include a side port and can be integrated, having an extension fitting extending from the side port. In some embodiments, the catheter adapter 12 can be straight or non-integrated. As shown, for example, in Figures 1A - 1B in some embodiments with a straight or non-integrated catheter, the catheter adapter 12 may not include a side port and / or an extension fitting extending from the side port. The connector 30 can include any suitable septum 38, which can prevent blood and / or other fluids from leaking out of the connector 30 in the proximal direction. In some embodiments, the septum 38 can be disposable or reusable. In some embodiments, a septum 40 can be disposed within the lumen 18, which can prevent blood and / or other fluids from leaking out of the proximal end 16 of the catheter adapter 12. Additionally, in some embodiments, a septum actuator can be disposed within the lumen 18.

[0045] In some embodiments, one or more of the following options can form a straight path 41 for delivering an instrument to the catheter system 10 and / or the vasculature: the lumen 18, the catheter 20, the connector 30, the extension tube 24, and the connector 34. In some embodiments, the straight path 41 can be aligned with the longitudinal axis 42 of the catheter assembly 22. In some embodiments, the straight path 41 can reduce the likelihood of kinking or bending of the instrument. In some embodiments, for example, in the case where the instrument includes a fitting for infusion or blood withdrawal, kinking can cause blockage, which can slow or stop the flow of fluid or blood through the fitting. In some embodiments, the straight path 41 can be unobstructed.

[0046] In some embodiments, the extension tube 24 can be rigid, semi-rigid, or flexible. In some embodiments, the extension tube 24 can allow for the delivery of an instrument in a remote manner, which can reduce interference with the catheter insertion site. In some embodiments, the extension tube 24 can be a first extension tube. In some embodiments, the catheter system 10 can include a second extension tube 44, which can be coupled to the extension tube 24. In some embodiments, the second extension tube 44 can be disposed at an angle relative to the extension tube 24.

[0047] In some embodiments, the hardness of the extension tube 24 can be greater than the hardness of the second extension tube 44. In some embodiments, the hardness of the extension tube 24 can be less than the hardness of the catheter adapter 12, which can reduce the risk of interfering with the insertion site of the catheter 20. In some embodiments, the extension tube 24 and / or the second extension tube 44 can include a clamp 39. In some embodiments, the second extension tube 44 can be coupled to the straight path 41 distal or proximal to the connector 30.

[0048] In some embodiments, the extension tube 24 may include a rigid or semi-rigid portion with a straight path 41 therethrough to facilitate delivery of the instrument into the catheter system 10, and / or the second extension tube 44 may be more flexible or compliant to cause less irritation to the patient's skin. In some embodiments, the second extension tube 44 may be rigid, semi-rigid, or flexible. In some embodiments, the durometer hardness of the extension tube 24 may be between 70 Shore A and 95 Shore A (including the endpoint values 70 Shore A and 95 Shore A of the above range). In some embodiments, the durometer hardness of the extension tube 24 may be greater than 95 Shore A. In some embodiments, the durometer hardness of the second extension tube 44 may be about 35 Shore A or between 70 Shore A and 95 Shore A. In some embodiments, the length included in the extension tube may allow the instrument placed in the catheter system 10 to reach within the catheter adapter 12, within the catheter 20, and / or beyond the catheter 20 and into the patient's vasculature.

[0049] In some embodiments, the proximal end of the second extension tube 44 or the end of the second extension tube 44 opposite the end of the second extension tube 44 that is coupled to the extension tube 24 may include a connector 46, such as a Luer adapter or another suitable connector. In some embodiments, the connector 46 may connect the second extension tube 44 to a blood collection device or an infusion member.

[0050] In some embodiments, the connector 30 may include a Y-shaped adapter, for example, as Figures 1A - 1B shown. In some embodiments, the second extension tube 44 may be coupled to the extension tube 24 via the Y-shaped adapter. In some embodiments, the first port of the Y-shaped adapter may be aligned with the longitudinal axis 42 of the catheter assembly 22. In some embodiments, the second extension tube 44 may extend from the second port of the Y-shaped adapter. In some embodiments, the catheter system 10 may include the extension tube 24 but not the second extension tube 44.

[0051] In some embodiments, the extension kit 47 for the catheter assembly 22 may include one or more of the following options: the extension tube 24, the connector 30 coupled to the proximal end 28 of the extension tube 24, the connector 34 coupled to the distal end 26 of the extension tube 24, the second extension tube 44, and the connector 46. In some embodiments, the extension tube 24, the connector 30, and the connector 34 may form at least a portion of the straight path 41.

[0052] Now refer to Figure 1C, in some embodiments, the instrument delivery device 48 can be coupled to the connector 30. In some embodiments, the instrument delivery device 48 can include any type of delivery device capable of being coupled to the connector 30. In some embodiments, the instrument delivery device 48 can include an instrument 50, such as a guide wire, a probe with a sensor, a tube for fluid infusion or blood withdrawal, a light tube for disinfection, or other suitable instruments. In some embodiments, the instrument 50 can be advanced distally into the catheter system 10 through and / or from the instrument delivery device 48. In some embodiments, the distal end of the instrument 50 can be advanced beyond the distal end 52 of the catheter 20. In some embodiments, the distal end of the instrument 50 can be advanced to a position within the catheter assembly 22 and / or the vasculature. As Figure 1C shown, in some embodiments, the instrument 50 can include a blood withdrawal tube, which can be coupled to a blood collection device, such as a blood collection tube or an adapter for a blood collection tube.

[0053] Now referring to Figures 1D - 1E , in some embodiments, the catheter system 10 can include a stabilization feature 54. In some embodiments, the stabilization feature 54 can be disposed between the connector 30 and the distal end 26 of the extension tube 24. In some embodiments, the extension tube 24 can extend through the stabilization feature 54.

[0054] In some embodiments, the stabilization feature 54 can include one or more platforms 55, which can be configured to contact the patient's skin. In some embodiments, a particular platform 55 can include one or more wings. In some embodiments, a particular platform 55 can extend on both sides of the longitudinal axis 22 and / or can include two generally parallel arms joined by a connector portion, for example, as Figure 1E shown.

[0055] In some embodiments, the stabilization feature 54 can be fixed relative to the extension tube 24. In some embodiments, the stabilization feature 54 can rotate around the longitudinal axis of the extension tube 24 on the extension tube 24. In some embodiments, the stabilization feature 54 can be integrally formed with the extension tube 24. In some embodiments, the stabilization feature 54 can be a discrete component different from the extension tube 24. In some embodiments, the stabilization feature 54 can snap onto the extension tube 24.

[0056] In some embodiments, during insertion of the instrument 50 through the extension tube 24, the stabilization feature 54 can stabilize the extension tube 24 and / or the extension kit 47. In some embodiments, during insertion of the instrument 50 through the extension tube 24, one or more fingers of the user can grasp or contact the upper surface of the platform 55 to stabilize the catheter system 10.

[0057] In some embodiments, the stabilization feature 54 may be provided on the connector 30 or the connector 34. In some embodiments, the stabilization feature 54 may be fixed relative to the connector 30 and / or the connector 34. In some embodiments, the stabilization feature 54 may rotate on the connector 30 and / or the connector 34. In some embodiments, the stabilization feature 54 may be integrally formed with the connector 30 and / or the connector 34 as a single unit or formed integrally. In some embodiments, the stabilization feature 54 may be a discrete component different from the connector 30 and / or the connector 34. In some embodiments, the stabilization feature 54 may snap onto the connector 30 and / or the connector 34. In some embodiments, the stabilization feature 54 and / or the catheter system 10 may be low-profile.

[0058] In some embodiments, the catheter system 10 may include a plurality of stabilization features 54. In some embodiments, the catheter system 10 may include stabilization features 54 on one or more of the catheter adapter 12, the connector 30, the connector 34, and the extension tube 24. Figure 1D A first stabilization feature 54a and a second stabilization feature 54b are shown. In some embodiments, the first stabilization feature 54a may be provided between the connector 30 and the distal end 26 of the extension tube (e.g., as Figure 1B shown). In some embodiments, the second stabilization feature 54b may be provided on the catheter adapter 12. The first stabilization feature 54a and the second stabilization feature 54b may be collectively referred to as "stabilization feature 54" in the present disclosure. In some embodiments, the needleless connector 53 may be coupled to one or more of the connectors 30, 34, and 46. In some embodiments, a particular needleless connector 53 may be provided between the connector 30 and the instrument delivery device 48. In some embodiments, a particular needleless connector 53 may be provided between the connector 34 and the proximal end of the catheter adapter 12.

[0059] In some embodiments, the platforms 55 may each include an adhesive layer 56 that may be configured to contact the skin of the patient. In some embodiments, the adhesive layer 56 may be covered by a removable backing layer that may be removed before fixing the stabilization feature 54 to the patient.

[0060] Now refer to Figures 1F - 1G, in some embodiments, the catheter system 10 may include a fixation fabric 58 that may be coupled to the stabilization feature 54 (such as the platform 55) and / or extend beneath the stabilization feature 54. In some embodiments, the fabric 58 may extend outwardly from the platform 55 or away from the longitudinal axis of the extension tube 24. In some embodiments, the fabric 58 may include an adhesive layer 60 that may be configured to contact the patient's skin. In some embodiments, the adhesive layer 60 may be covered by a removable backing layer that may be removed before fixing the stabilization feature 54 to the patient.

[0061] Now referring to Figure 1H , in some embodiments, the catheter system 10 may include a dressing 62. In some embodiments, the dressing 62 may be disposed on top of the fixation feature 54 and / or the fabric 58. The dressing 62 may be used to secure the catheter system 10 and / or prevent contamination or infection. In some embodiments, as a supplement to or an alternative to the adhesive layer 56 and / or the adhesive layer 60, the dressing 62 may help to stabilize or fix the fixation feature 54, the fabric 58, and / or the catheter system 10. In some embodiments, the dressing 62 may include a slit or slot that is aligned with the extension tube 24, which may allow access to the connector 30 and allow some movement of the extension tube 24 without providing a directional lever on the catheter adapter 12 at the insertion site of the catheter 20.

[0062] Now referring to Figure 1H , in some embodiments, the second extension tube 44 may be disposed at an angle relative to the extension tube 24. As Figure 1H shown, in some embodiments, the port of the connector 30 and the second extension tube 44 may be directed distally or face distally. In other embodiments, as Figure 1A shown, for example, the port of the connector 30 and the second extension tube 44 may be directed proximally or face proximally. In other embodiments, the port of the connector 30 and the second extension tube 44 may be perpendicular to the adapter catheter 12.

[0063] Now referring to Figure 1J , in some embodiments, a portion of the straight path 41 that extends through the connector 30 and / or the extension tube 24 may be smooth to prevent the instrument 50 from being interfered with by any clips (such as any sharp edges or obstruction points) within the connector 30. In some embodiments, the entire straight path 41 may be smooth without any clips, thereby allowing the instrument to move smoothly forward in the distal direction through the straight path 41 and / or retract smoothly in the proximal direction through the straight path 41. In some embodiments, any clips disposed within the connector 30 and / or at the transition between the connector 30 and the extension tube 24 may be positioned behind the smooth features and geometries to prevent the instrument 50 from getting stuck or snagged.

[0064] More specifically, in some embodiments, an inner surface of the connector 30 may form a part of the straight path 41. In some embodiments, a portion of the inner surface of the connector 30 proximal and adjacent to the proximal end 28 of the elongate tubular member 28 may be flush with or extend more inwardly than the inner surface of the elongate tube 24. This may prevent the instrument 50 from getting stuck on the proximal end 28 of the elongate tube 24 when the instrument 50 is advanced distally. In some embodiments, the inner surface of the proximal end 28 of the elongate tubular member 24 may be disposed at an equal distance from or further from the longitudinal axis of the connector 30 than a portion of the inner surface of the connector 30 proximal and adjacent to the proximal end 28 of the elongate tubular member 24. In some embodiments, the inner diameter of the straight path 41 proximal and adjacent to the proximal end 28 of the elongate tube 24 may be approximately equal to or less than the inner diameter of the elongate tube 24.

[0065] Now referring Figures 2A - 2B , in some embodiments, the stabilizing feature 54 may include one or more snap features 63, which may allow the stabilizing feature 54 to snap onto the elongate tube 24.

[0066] Now referring Figures 2C - 2E , there is shown a stabilizing feature 72 according to some embodiments. In some embodiments, the stabilizing feature 72 may include or correspond to a connector support device described in U.S. Patent Application No. 62 / 786,732, filed Dec. 31, 2018, entitled “VASCULAR ACCESS CONNECTOR SUPPORT DEVICE, SYSTEMS, AND METHODS”, which is incorporated herein by reference in its entirety.

[0067] In some embodiments, the stabilizing feature 72 may be wedge-shaped, which may facilitate supporting the connector 34 at an angle at which the catheter 20 is inserted into a patient. More specifically, in some embodiments, the upper surface 74 of the stabilizing feature 72 may include a groove 76, which may be aligned with the longitudinal axis of the catheter 20. In some embodiments, the connector 34 may rest within the groove 76. In some embodiments, the thickness of the stabilizing feature 72 at the proximal end of the groove 76 may be greater than the thickness of the stabilizing feature 72 at the distal end of the groove 76, such that the groove 76 may support the connector 34 at the insertion angle. In some embodiments, the insertion angle may be approximately 30° or less. In some embodiments, the insertion angle may be between 0° and 40°. Thus, in some embodiments, the stabilizing feature 72 may include a wedge having an angle of approximately 30° or less, or between 0° and 40°.

[0068] In some embodiments, the connector 34 may extend into and / or through a loop 78 of the stabilization feature 72, which may extend from the upper surface 74. In some embodiments, the distal end of the connector 34 may include a luer adapter, which may include a rotating collar luer lock. In some embodiments, a rotating collar luer lock that may be threaded may be provided distally of the loop 78 to facilitate access and rotation by a clinician. In some embodiments, the portion of the connector 34 proximal to the rotating collar luer lock may extend into and / or through the loop 78 of the stabilization feature 72. In some embodiments, the outer surface of the rotating collar luer lock may include one or more ribs to facilitate tightening or loosening of the rotating collar luer lock by a clinician.

[0069] In some embodiments, the loop 78 may contact the connector 34 and hold the connector 34 snugly in place. In some embodiments, the width 80 of the loop 78 may extend along all or a portion of the bridge 82, which may facilitate fixation of the connector 34. In some embodiments, the bridge 82 may engage four legs 84 of an H shape of the stabilization feature 72. In some embodiments, the stabilization feature 72 may not include a protrusion on the upper surface 74 that might otherwise contact and support a port or extension tube.

[0070] Now referring to Figures 3A - 3D , another catheter system 64 is shown. In some embodiments, the catheter system 64 may include or correspond to the catheter system 10 of FIG. 1. More specifically, the catheter system 64 may include one or more features of the catheter system 10. By way of illustration, the catheter system 64 may include one or more of the following options: a stabilization feature 54, a fabric 58, a second extension tube 44, and a connector 30. Similarly, in some embodiments, the catheter system 10 may include one or more features of the catheter system 64.

[0071] In some embodiments, the connector 30 may include a luer adapter. Now referring to Figure 3A , in some embodiments, the connector 30 may optionally include a blood control mechanism, such as a blood control diaphragm 65. In some embodiments, the connector 40 may include a diaphragm actuator 67 that may penetrate the diaphragm 65 in response to insertion of a luer device.

[0072] In some embodiments, the proximal end of the needle 68 may be fixed in the needle hub 70. In some embodiments, the catheter system 64 may include any suitable needle safety or shielding mechanism 69. In some embodiments, the safety mechanism 69 may be disposed in the needle hub 70, the catheter 12, and / or the connector 30 and / or selectively coupled to the needle hub 70, the catheter 12, and / or the connector 30. In some embodiments, the safety mechanism 69 may be disposed in another connector (e.g., a needleless connector) and / or selectively coupled to another connector (e.g., a needleless connector), and the other connector may be located between the connector 30 and the needle hub 70.

[0073] The safety mechanism 69 may be coupled or selectively coupled to the catheter system 64 in a variety of ways. For example, the safety mechanism 69 may include an external interlock (e.g., similar to the BD NEXIVA TM Closed IV Catheter System) or an internal interlock. In some embodiments, the safety mechanism 69 may be active (e.g., similar to the BD INSYTE TM AUTOGUARD TM BC Shielded IV Catheter) or passive. In some embodiments, the safety mechanism 69 may seal the sharp distal end of the needle 68 in response to the needle 68 being withdrawn proximally (e.g., similar to the BD SAF-T-INTIMA TM Closed IV Catheter System).

[0074] Now referring to Figures 3B - 3D , according to some embodiments, a clip 66 is shown, which is an illustration of a safety mechanism having an internal interlock. Although the septum 65 and the septum actuator 67 are not shown in Figures 3B - 3D , it should be understood that the connector 30 may include one or more of the following options: the septum 65, the septum actuator 67, and the clip 66. In some embodiments, in response to the needle 68 being withdrawn proximally from the catheter adapter 12, the sharp distal end of the needle 68 may be shielded in the clip 66, and the clip 66 may be detached and removed from the catheter system 64. In some embodiments, the clip 66 may be disposed within the catheter adapter 12 and / or selectively coupled to the catheter adapter 12. In some embodiments, the clip 66 may be disposed within the connector 30 and / or selectively coupled to the connector 30. In some embodiments, after the needle 68 is removed from the catheter system 64, the instrument delivery device 48 may be coupled to the connector 30.

[0075] Now referring to Figures 3A - 3D , in some embodiments, the extension tube 24 may be pre-attached to the catheter adapter 12. In these and other embodiments, the distal end 26 of the extension tube 24 may be fixedly coupled to or integrated with the proximal end of the catheter adapter 12, e.g., as Figures 3A - 3DAs shown. In some embodiments, the distal end 26 of the extension tube 24 may be disposed within the catheter adapter 12.

[0076] All of the examples and conditional language recited herein are for pedagogical purposes to aid the reader in understanding the invention and the concepts contributed by the inventor to further the art, and are to be construed as not being limited to such specifically recited examples and conditions. Although the embodiments of the invention have been described in detail, it should be understood that various changes, substitutions and alterations can be made thereto without departing from the spirit and scope of the invention.

Claims

1. A catheter system, comprising: A catheter adapter having a distal end, a proximal end axially aligned with the distal end, and a lumen extending between the distal end and the proximal end; A catheter extending distally from the distal end of the catheter adapter; A Luer adapter coupled to the proximal end of the catheter adapter; A first extension tube having a distal end and a proximal end, wherein the distal end of the first extension tube is fixedly coupled to the Luer adapter; and A connector fixedly coupled to the proximal end of the first extension tube, wherein a straight path for delivering an instrument to the catheter system is formed in the connector, the first extension tube, the lumen, and the catheter, and the straight path from the proximal end of the connector to the distal end of the first extension tube is smooth such that the instrument can move forward smoothly through the straight path; and A second extension tube coupled to the first extension tube, wherein the first extension tube is harder than the second extension tube.

2. The catheter system according to claim 1, wherein, The first extension tube is rigid or semi-rigid.

3. The catheter system according to claim 1, wherein, The distal end of the first extension tube is fixedly coupled to the proximal end of the catheter adapter.

4. The catheter system according to claim 1, wherein, The second extension tube is arranged at an angle relative to the first extension tube.

5. The catheter system according to claim 1, wherein, The connector includes a Y-shaped adapter having a first port and a second port, wherein the first port is configured to be coupled to an instrument delivery device, and the second extension tube extends from the second port of the Y-shaped adapter.

6. The catheter system according to claim 1, further comprising a stabilization feature disposed between the connector and the distal end of the first extension tube.

7. The catheter system according to claim 6, wherein, The stabilization feature includes a platform, wherein the platform includes an adhesive layer configured to contact the patient's skin.

8. The catheter system according to claim 6, further comprising a fabric coupled to and extending outwardly from the stabilizing feature, wherein, The fabric includes an adhesive layer configured to contact the patient's skin.

9. The catheter system according to claim 6, wherein, The stabilization feature rotates around the longitudinal axis of the first extension tube on the first extension tube.

10. The catheter system according to claim 6, wherein, The first extension tube extends through the stabilization feature, wherein the stabilization feature is fixed relative to the first extension tube.

11. The catheter system according to claim 1, wherein, The connector includes a blood control diaphragm.

12. The catheter system according to claim 1, wherein, The connector is removably coupled to the proximal end of the first extension tube.

13. The catheter system according to claim 1, wherein, The connector is fixedly coupled to the proximal end of the first extension tube.

14. The catheter system according to claim 6, wherein: The stabilization feature is integrally formed with the first extension tube or the connector; or The stabilization feature is a discrete component different from the first extension tube or the connector, and the stabilization feature can be snapped onto the first extension tube or the connector.

15. The catheter system according to claim 6, wherein, The stabilization feature and / or the catheter system is of low profile.

16. A catheter system, comprising: A catheter adapter having a distal end, a proximal end axially aligned with the distal end, and a lumen extending between the distal end and the proximal end; A catheter extending distally from the distal end of the catheter adapter; An extension tube having a distal end and a proximal end, wherein the distal end of the extension tube is fixedly coupled to the proximal end of the catheter adapter or is integral with the proximal end of the catheter adapter; A connector fixedly coupled to a proximal end of the extension tube, wherein a smooth straight path for delivering an instrument to the catheter system is formed in the connector, the extension tube, the lumen, and the catheter; and A stabilization feature disposed between a proximal end of the connector and a distal end of the extension tube; Wherein the extension tube is rigid or semi-rigid.

17. The catheter system according to claim 16, wherein, The straight path from the proximal end of the connector to the distal end of the extension tube is smooth such that the instrument can be smoothly advanced through the straight path.

18. The catheter system according to claim 16, wherein, The stabilization feature includes a platform, wherein the platform includes an adhesive layer configured to contact a patient's skin.

19. The catheter system according to claim 16, further comprising a fabric coupled to and extending outwardly from the stabilizing feature, wherein, The fabric includes an adhesive layer configured to contact a patient's skin.

20. The catheter system according to claim 16, wherein, The stabilization feature rotates about a longitudinal axis of the extension tube on the extension tube.

21. The catheter system according to claim 16, wherein, The extension tube extends through the stabilization feature, wherein the stabilization feature is fixed relative to the extension tube.

22. The catheter system according to claim 16, wherein: The stabilization feature is integrally formed with the extension tube or the connector; or The stabilization feature is a separate component different from the extension tube or the connector, and the stabilization feature can be snapped onto the extension tube or the connector.

23. The catheter system according to claim 16, wherein, The stabilization feature and / or the catheter system is low profile.

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