Probe propulsion device and related systems and methods

Abstract

The present invention relates to a probe advancement device and related systems and methods. The probe advancement device can be configured to be coupled to a catheter assembly. The probe advancement device can include a flexible housing that can include a proximal end and a distal end. The probe advancement device can include a probe advancement element coupled to the proximal end of the flexible housing. The probe advancement element can include a probe that extends in a distal direction within the flexible housing. The flexible housing can be configured to collapse along an axis in response to the probe being advanced in the distal direction. The probe can include a tube for blood collection, a guidewire, or other suitable element.

Description

TECHNICAL FIELD

[0001] The present invention relates to probe advancement devices and related systems and methods. BACKGROUND

[0002] Catheters are commonly used to infuse fluids into a patient's vasculature. For example, catheters can be used to infuse solutions of physiological saline, various medicaments, or total parenteral nutrition. Catheters can also be used to withdraw blood from a patient.

[0003] Catheters can include an over-the-needle peripheral intravenous ("IV") catheter. In this case, the catheter can be mounted on an introducer needle having a sharp distal tip. The catheter and introducer needle can be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle facing upward away from the skin of the patient. The catheter and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.

[0004] To verify proper placement of the introducer needle and / or catheter in the blood vessel, the clinician typically confirms the presence of "flashback" of blood in a flashback chamber of the catheter assembly that includes the catheter. After the placement of the needle has been confirmed, the clinician can remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.

[0005] Catheters often provide an access port through which other devices can gain access to the catheter while the catheter is positioned in the patient's vasculature. These other devices can be used to perform various tasks, such as obtaining a blood sample, injecting a fluid, performing a measurement, monitoring, etc. In many cases, the catheter of an IV catheter device can become occluded (e.g., by a thrombus or fibrin sheath), which can hinder performance of such tasks. If the catheter has become occluded, the clinician can attempt to remove the occlusion, such as by inserting a needle, wire, or other structure through the catheter. However, removal of the blockage using currently available techniques is not always effective, is often difficult to perform, and can cause trauma to the patient's vasculature.

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

[0007] The present disclosure relates generally to a probe advancement device that facilitates advancement of a probe within a catheter, and related systems and methods. In some embodiments, the probe advancement device can be used to perform various tasks, including obtaining a blood sample. In many cases, a catheter of an IV catheter device can become occluded (e.g., by a thrombus or fibrin sheath), which can prevent successful blood withdrawal. In some embodiments, a probe can be advanced by the probe advancement device to remove the occlusion or provide a path through the occlusion.

[0008] In some embodiments, the probe advancement device can be configured to couple to a catheter assembly. In some embodiments, the probe advancement device can include a flexible housing that can include a proximal end and a distal end. In some embodiments, a probe advancement element can be coupled to the proximal end of the flexible housing. In some embodiments, the probe advancement element can include a probe that extends within the flexible housing in a distal direction. In some embodiments, the flexible housing can be configured to collapse along an axis in response to the probe being advanced in the distal direction.

[0009] In some embodiments, the probe can include one of a guidewire and a tube. In some embodiments, the proximal end of the probe advancement element can be configured to couple to a blood collection device.

[0010] In some embodiments, the probe advancement device can include a support element disposed within the flexible housing. In some embodiments, a distal end of the support element includes a male luer and a proximal end of the support element includes a female luer. In some embodiments, the probe can extend through the support element.

[0011] In some embodiments, the probe advancement device can include a plurality of support elements spaced apart within the flexible housing. In some embodiments, the probe can extend through the support elements. In some embodiments, a distal end of each support element can include a male luer and a proximal end of each support element can include a female luer. In some embodiments, each support element can be configured to lock onto the probe.

[0012] In some embodiments, an end connector can be disposed at the distal end of the flexible housing and another connector can be disposed at the proximal end of the flexible housing. In some embodiments, the end connector can be configured to couple to the other connector in response to the probe being advanced in the distal direction and the collapse of the flexible housing. In some embodiments, the end connector can include a female luer adapter and the other connector can include a male luer adapter.

[0013] In some embodiments, the probe advancement device can include an alignment rod disposed within the flexible housing to maintain alignment between the probe advancement element and the end connector. In some embodiments, at least a portion of the flexible housing can be transparent such that the probe is visible through the flexible housing.

[0014] In some embodiments, the probe advancement device can include a biasing member disposed within the flexible housing between the probe advancement element and the distal end of the flexible housing. In some embodiments, the biasing member can be configured to bias the probe in a retracted position. In some embodiments, the probe advancement element can be configured to compress the biasing member in a distal direction to cause the flexible housing to collapse along the axis in response to the probe being advanced in the distal direction.

[0015] In some embodiments, the probe advancement device can include a proximal access gripping element disposed within the flexible housing toward the distal end of the flexible housing. In some embodiments, the proximal access gripping element can be configured to manipulate the position of the probe within the flexible housing. In some embodiments, the proximal access gripping element can include a first end and a second end configured to be elastically pinched together such that the probe is held between the first end and the second end. In some embodiments, the proximal access gripping element can be configured to selectively translate within the flexible housing along or parallel to the axis.

[0016] In some embodiments, the probe advancement system can include a blood collection device, a flexible housing, and a probe advancement element. In some embodiments, a fluid pathway can extend through the flexible housing and / or into the blood collection device. In some embodiments, the probe advancement system can include a catheter assembly that can be coupled to the distal end of the flexible housing and in fluid communication with the fluid pathway. In some embodiments, the catheter assembly can be configured to receive a probe therethrough.

[0017] In some embodiments, the fluid pathway can extend around the probe and / or between the probe and an inner surface of the flexible housing. In these embodiments, the fluid pathway can be configured to collapse along the axis of the flexible housing in response to the probe being advanced in a distal direction. In some embodiments, the probe can include a tube, and the fluid pathway can extend through the tube. In some embodiments, the proximal end of the flexible housing can include another connector. In some embodiments, the other connector can include a shaft, and the tube can extend distally from the shaft. In some embodiments, the distal end of the flexible housing can include an end connector, and the shaft can be configured to be inserted into the end connector to form a fluid-tight seal.

[0018] In some embodiments, a method of advancing a probe for blood extraction can include coupling a probe advancement device to a catheter assembly. In some embodiments, the catheter assembly can include a catheter adapter that can include a proximal end, a distal end, and a lumen extending therethrough. In some embodiments, the catheter assembly can include a catheter extending from the distal end of the catheter adapter, and the catheter can be an intravenous catheter. In some embodiments, the method can include coupling a blood collection device to the probe advancement device. In some embodiments, the probe can be advanced in a distal direction to create a fluid passageway through the catheter assembly. In some embodiments, after the probe is advanced in the distal direction, the blood collection device can be actuated to collect blood from the patient via the fluid passageway.

[0019] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application as claimed. It should be understood that various embodiments are not limited to the arrangements and instrumentalities shown in the attached drawings. It should also be understood that embodiments can be combined or that other embodiments can be utilized, and that structural changes can be made without departing from the scope of the various embodiments of the present application unless so claimed. Accordingly, the following detailed description is not to be understood as limiting. BRIEF DESCRIPTION OF DRAWINGS

[0020] Example embodiments will be described and explained with additional specificity and detail by the use of the accompanying drawings in which:

[0021] FIG. 1A is a perspective view of an example probe advancement device according to some embodiments;

[0022] FIG. 1B is a top perspective view of an example probe advancement system according to some embodiments;

[0023] FIG. 2A is a cross-sectional view of another example probe advancement device according to some embodiments showing an example probe including a tube;

[0024] FIG. 2B is a cross-sectional view of another example probe advancement device according to some embodiments showing an example probe including a guidewire;

[0025] FIG. 3 is a perspective view of another example probe advancement device according to some embodiments;

[0026] FIG. 4 is a cross-sectional view of another probe advancement device configured according to some embodiments;

[0027] FIG. 5 is a cross-sectional side view of an example support element disposed within an example flexible housing according to some embodiments;

[0028] FIG. 6A is a cross-sectional view of one example of a septum disposed within an example adapter according to some embodiments;

[0029] FIG. 6B is a cross-sectional view of a septum according to some embodiments; FIG. 6A is a cross-sectional view of a septum showing another example probe;

[0030] FIG. 6C is a cross-sectional view of another example of a septum disposed within an adapter according to some embodiments;

[0031] FIG. 6D is a cross-sectional view of another example of a septum disposed within an adapter according to some embodiments;

[0032] FIG. 6E is a cross-sectional view of a septum according to some embodiments; FIG. 6D is a cross-sectional view of a septum showing an example probe being advanced through the septum;

[0033] FIG. 7A is a top perspective view of a proximity access grip element according to some embodiments;

[0034] FIG. 7B is a side view of a proximity access grip element of FIG. 7A

[0035] is a perspective view of a proximity access grip element and an example probe according to some embodiments; FIG. 7C FIG. 7A is a perspective view of a proximity access grip element of

[0036] FIG. 7D is a perspective view of a proximity access grip element of FIG. 7A

[0037] is a perspective view of a proximity access grip element of FIG. 7E FIG. 7A is a perspective view of a proximity access grip element of DETAILED DESCRIPTION

[0038] In the specification and claims, the term "catheter assembly" shall be construed to include any device that includes an IV catheter. The term "probe advancement device" shall be construed to include any device configured to advance and / or retract a probe within an IV catheter. In some embodiments, the probe advancement device can be a separate device from the catheter assembly, which can be used with the catheter assembly. In other embodiments, the probe advancement device can include or can be integrally formed with the catheter assembly as a single unit.

[0039] FIG. 1A and FIG. 1B ​​A probe advancement device 30 for advancing a probe 46 within a catheter 72 is shown. In some embodiments, the probe 46 can include a tube through which blood can flow. In other embodiments, the probe 46 can include a guidewire, such as, for example, a nickel-titanium guidewire.

[0040] Various embodiments of the probe advancement device 30 can be used to perform various tasks, including, for example, obtaining a blood sample. For example, in some embodiments, the probe advancement device 30 can deliver a probe 46 through the catheter assembly 62 to clear a portion of the catheter 72 that has become occluded (e.g., due to a thrombus or fibrin sheath). Failure to clear such an occlusion can prevent successful blood withdrawal. Some embodiments presented herein can shorten the effective length of a flexed column of the probe 46 and / or reduce drag as the probe 46 is advanced distally.

[0041] Reference is now made to FIG. 1A In a first set of example embodiments, the probe advancement device 30 can include a flexible housing 32 having a proximal end 36 and a distal end 38, which, in some embodiments, can include a flexible biocompatible plastic material or other suitable flexible medical grade polymer, such as, for example, one or more of the following: polyethylene, PEEK, polycarbonate, polyetherimide, polysulfone, polypropylene, and polyurethane. In some embodiments, the flexible housing 32 can include a transparent material to facilitate viewing of an obstruction and / or a probe 46 advanced or therein. In some embodiments, the flexible housing 32 can include an accordion-like structure forming a collapsible lumen or fluid passageway. In some embodiments, the flexible housing 32 can be aligned with an axis 42. In some embodiments, the axis 42 can include a central or longitudinal axis of the flexible housing 32, which can extend through the proximal end 36 and the distal end 38.

[0042] In some embodiments, the probe advancement element 44 can be coupled to the proximal end of the flexible housing 32. In some embodiments, the probe advancement element 44 can include a rigid or resilient material. In some embodiments, the probe advancement element 44 can include a shape that substantially matches a cross-sectional profile of the flexible housing 32. As shown, for example, the flexible housing 32 can form a cylinder, while the probe advancement element 44 can form a circle having a diameter that substantially matches a diameter of the cylinder. In this way, in some embodiments, the probe advancement element 44 can substantially occlude the proximal end 36 of the flexible housing 32. In some embodiments, the probe advancement element 44 can include any suitable shape to substantially occlude the proximal end 36 of the flexible housing 32.

[0043] In some embodiments, the proximal end 36 of the probe advancement device 30 can include a luer adapter or other coupling feature configured to couple to a corresponding luer adapter or coupling feature disposed at the distal end 38. In this way, in some embodiments, the flexible housing 32 can be compressed or fully compressed by coupling the coupling feature at the proximal end 36 to the corresponding coupling feature at the distal end 38. In some embodiments, the proximal end 36 of the probe advancement device 30 can include a male luer that can include a shaft 81 configured to couple to a female luer at the distal end 38.

[0044] In some embodiments, the probe 46 can extend within the flexible housing 32 from the probe advancement element 44 in a distal direction. In some embodiments, the probe 46 can include a guidewire or a tube. In some embodiments, the tube can be cylindrical. In some embodiments, the flexible housing 32 can be configured to collapse along the axis 42 as the probe 46 is advanced in the distal direction. For example, in some embodiments, the accordion-like structure of the flexible housing 32 can cause the flexible housing 32 to have a length that gradually shortens in response to the probe 46 being advanced in the distal direction.

[0045] In some embodiments, as discussed in greater detail below, the probe advancement device 30 can also include a proximity access grasping element 52. In some embodiments, the proximity access grasping element 52 can be disposed within the flexible housing 32 and / or proximate to the distal end 38. Some embodiments of the proximity access grasping element 52 can be configured to manipulate the position of the probe 46 within the flexible housing 32. In this way, the probe 46 can be advanced through part or all of a catheter (e.g., see catheter 72 in FIG. 1) to clear an obstruction, thereby facilitating successful blood extraction. FIG. 1B

[0046] In some embodiments, a seal, such as, for example, an O-ring seal or other suitable rubber or plastic seal, can be disposed between the probe advancement element 44 and the proximal end 36 of the flexible housing 32. In some embodiments, a luer adapter or other coupling feature can be coupled to or integrated with the probe advancement element 44. In these and other embodiments, the luer adapter or other coupling feature can form a seal at the proximal end 36. In this way, in some embodiments, the probe 46 can include a guidewire and / or the flexible housing 32 can form a gas-impermeable fluid pathway through which blood can be drawn using the LAD (“LLAD,” available from Becton Dickinson & Company of Franklin Lakes, New Jersey), a syringe, or other suitable blood collection device. LUER-LOK TM access device (“LLAD,” available from Becton Dickinson & Company of Franklin Lakes, New Jersey), a syringe, or other suitable blood collection device.

[0047] ​In some embodiments, the probe 46 can include a tube, and the tube can extend from the probe advancement element 44. In some embodiments, as the tube is advanced in the distal direction through the flexible housing 32, the tube can form a fluid path through which blood can be drawn using the blood collection device 60, such as an LLAD or, for example, a syringe.

[0048] In some embodiments, the probe 46 can clear the obstruction by one or more of the following: moving the catheter 72 tip; removing a thrombus or other obstruction from the catheter 72; extending a new fluid path to a new source of blood; holding thrombus at bay; opening one or more valves; and moving the catheter 72 away from the obstruction. In some embodiments, the site and / or position of the probe 46 can be adjusted after initial deployment to facilitate clearing a path for blood draw. In some embodiments, the probe advancement device 30 can provide tactile and / or audible feedback to the user to indicate that initial advancement of the probe 46 is complete.

[0049] Referring now to FIG. 1B , the probe advancement system 78 can include the blood collection device 60, the probe advancement device 30, and the catheter assembly 62. In some embodiments, the catheter assembly 62 can include a catheter adapter 64 having a proximal end 68, a distal end 70, and a catheter 72 extending from the distal end 70. In some embodiments, an extension tube 66 can extend from a side port of the catheter adapter 64. FIG. 1B A probe advancement system 78 is shown just prior to coupling the probe advancement device 30 to the catheter assembly 62 by inserting a male luer into the proximal end 68 or connector 69, in accordance with some embodiments.

[0050] In some embodiments, the probe advancement element 44 can be disposed at the proximal end 36 of the flexible housing 32 and can be coupled to the blood collection device 60. In some embodiments, the probe advancement element 44 can include a probe 46 extending in the distal direction within the flexible housing 32. In some embodiments, the flexible housing 32 can be configured to collapse along the axis 42 in response to the probe 46 being advanced in the distal direction.

[0051] Some embodiments of the flexible housing 32 can form a collapsible fluid passageway in fluid communication with the blood collection device 60. In these and other embodiments, blood can flow around the probe 46, which can include a guide wire. In other embodiments, the probe 46 can include a tube, and blood can flow fluidly through the tube rather than between the tube and an inner surface of the flexible housing 32.

[0052] In some embodiments, the probe advancement device 30 can include a connector element 50 disposed within the flexible housing 32 and configured to couple to an end connector 54 at the distal end 38 of the flexible housing 32. In some embodiments, at least a portion of the flexible housing 32 can be transparent such that the probe 46 is visible through the outer surface 34. In some embodiments, the shaft 81 and / or the probe 46 can be configured to fit through a bore of the connector 50, or can be configured to couple to a corresponding luer of the connector 50. In some embodiments, the connector 50 can include a generally circular disk and / or an extension that extends distally from the generally circular disk to the end connector 54, which can be attached to the end connector.

[0053] As discussed in greater detail below, in some embodiments, a proximity access gripping element 52 can be disposed within the flexible housing 32 proximate the distal end 38. In some embodiments, the proximity access gripping element 52 can be fixed to the extension of the connector element 50. Some embodiments of the proximity access gripping element 52 can be configured to manipulate the position of the probe 46 within the flexible housing 32.

[0054] In some embodiments, a biasing member 56, such as, for example, a spring, can extend between the connector element 50 and the proximal end 36 such that the probe 46 is biased in a retracted position. In some embodiments, the biasing member 56 can be compressed as the probe 46 is advanced distally. In some embodiments, the biasing member 56 can be configured to automatically retract the probe 46 in a proximal direction.

[0055] In some embodiments, a catheter assembly 62 can be coupled to the distal end 38 of the flexible housing 32. In some embodiments, the catheter assembly 62 can be coupled to the probe advancement device 30 and in fluid communication with a collapsible fluid passageway and / or a fluid passageway through the probe 46. In some embodiments, the catheter assembly 62 can be configured to receive the probe 46 therethrough.

[0056] Referring now to FIG. 2A-FIG. 2B In some embodiments, advancement of the probe 46 can be achieved by gripping the proximal end 36 of the probe advancement device 30 and moving the probe 46 distally toward and / or through the catheter 72. In some embodiments, the proximal end 36 of the probe advancement device 30 can include a shape and / or texture that facilitates gripping of the proximal end 36 to manipulate the position of the probe 46. It will be appreciated that one or more features of FIG. 2 can be combined with one or more features of FIG. 1A and / or FIG. 1B FIG. 1, in some embodiments. FIG. 2A A probe 46 as a tube is shown in accordance with some embodiments. In some embodiments, the tube can be fixed within the shaft 81 in a fluid-tight manner, such as by adhesive or other suitable method. FIG. 2BA guidewire is shown as a probe 46 that can be secured to the shaft 81 by adhesive or other suitable method. In some embodiments, the guidewire can be embedded in the shaft 81. In some embodiments, the guidewire can include various shapes to facilitate thrombus removal. In some embodiments, the guidewire can include a straight portion and / or a helical portion 79. In some embodiments, the distal end of the guidewire can include a blunt element 81 that can include a ball, rounded surface, or other blunt element to avoid damage to the vein.

[0057] In some embodiments, the probe 46 can be moved in a distal direction through the catheter assembly and into the patient's vasculature or vein. In some embodiments, the proximal end 36 of the probe advancement device 30 can be rotated or its orientation can otherwise be adjusted to facilitate the flexible housing 32 to facilitate further advancement of the probe 46 in the distal direction. In some embodiments, the probe 46 can be advanced in the distal direction until it extends through the catheter 72 (see, e.g., FIG. 5). FIG. 1B ).

[0058] In some embodiments, the probe 46 can encounter an obstruction that inhibits advancement, such as a thrombus formed within the tip of the catheter 72 or an S-curve in the catheter 72 caused when the catheter 72 is inserted into the skin. In these embodiments, the access access gripping element 52 located near the distal end 38 can be used to support and advance the probe 46. In some embodiments, the access access gripping element 52 can facilitate easier manipulation of the probe 46 by providing a reduced buckling column length.

[0059] Indeed, in some embodiments, the probe 46 can have a small moment of inertia as it passes through the catheter 72 or catheter assembly 62. In some embodiments, while the tube or portions of the probe 46 can be well supported in the extended position by the catheter assembly 62, other portions can not. As a result, these unsupported portions can buckle when an insertion load is applied.

[0060] In this regard, the Euler buckling equation states:

[0061] Pcr = pi^2 E I / L^2

[0062] where the bending moment of inertia I is equal to I = pi r^4 / 4 for a solid wire or guidewire and I = pi (Ro^4 - Ri^4) / 4 for a tube. In some embodiments, since the probe 46 must pass through the inner diameter of the catheter 72, the R value can be very small, resulting in a very flexible column that can be prone to buckling. However, in some embodiments, shortening the push distance can result in a column that is significantly more rigid such that it can support the required insertion force.

[0063] In some embodiments, the access access grip element 52 can comprise rubber, plastic, metal, or any other suitable material to grip and / or manipulate the probe 46 within the flexible housing 32. In some embodiments, the access access grip element 52 can facilitate translation of the probe 46. In some embodiments, the access access grip element 52 can comprise external features that can be felt and / or manipulated by a user through the flexible housing 32. In some embodiments, the access access grip element 52 can further comprise one or more surfaces configured to interface or engage with the probe 46. For example, in some embodiments, the surfaces can comprise one or more grooves, notches, or other textures or materials to facilitate a secure interface between the access access grip element 52 and the probe 46.

[0064] In some embodiments, a user can manipulate the access access grip element 52 to grasp at least a portion of the length of the probe 46. In some embodiments, a user can move the access access grip element 52 to move the probe 46. In some embodiments, the access access grip element 52 can be translated or moved along the axis 42 to advance or retract the probe 46 within the catheter 72. In some embodiments, a user can manipulate the access access grip element 52 simultaneously with the proximal end 36 of the flexible housing 32 to move the probe 46 toward and / or through the catheter 72.

[0065] In some embodiments, the end connector 54 can comprise an adapter 80, which can comprise a female luer adapter on a proximal side and / or a male luer adapter on a distal side. In some embodiments, the proximal end 36 of the probe advancement device 30 can comprise a luer, such as, for example, the male luer shown in FIG. 2, which can comprise a width 57. In some embodiments, in response to advancement of the probe 46 distally and collapse of the flexible housing 32, the male luer can be configured to be inserted into the female luer of the end connector 54 such that the male luer seals the end connector 54. In some embodiments, the width or shape of the female luer can receive the width or shape of the male luer. In some embodiments, the male luer can contact an inner surface of the adapter 80 to form a seal that can reduce or prevent fluid flow through the adapter 80 when the probe 46 is advanced distally and the flexible housing 32 is collapsed. In some embodiments, by coupling the male luer to the female luer, the flexible housing 32 can be compressed or fully compressed. In some embodiments, the probe advancement device 30 can not comprise a septum, which can reduce drag on the probe 46. In other embodiments, the probe advancement device 30 can comprise a septum.

[0066] In some embodiments, a method of advancing a probe 46 for blood extraction can comprise coupling a probe advancement device 30 (e.g., see FIGS. 1-7) to a catheter assembly 62 (e.g., see FIGS. 8-10) to form a catheter assembly 62 and probe advancement device 30 combination. In some embodiments, the method can further comprise advancing the probe 46 distally within the catheter 72 to a desired location within the catheter 72. In some embodiments, the method can further comprise collapsing the flexible housing 32 to advance the probe 46 distally within the catheter 72. FIG. 2B). In some embodiments, the catheter assembly 62 can include a catheter adapter 64 having a proximal end 68, a distal end 70, and a catheter 72 extending from the distal end 70.

[0067] Some embodiments of the probe advancement device 30 can include a flexible housing 32 and a probe advancement element 44. In some embodiments, the flexible housing 32 can include a proximal end 36 and a distal end 38. In some embodiments, the flexible housing 32 can form a collapsible fluid pathway between the proximal end 36 and the distal end 38 and / or around a probe 46, which can include a guidewire. In other embodiments, as shown in FIG. 2, the fluid pathway can extend through the probe 46, which can include a tube. In these embodiments, the fluid pathway can not extend between the tube and the flexible housing 32.

[0068] In some embodiments, the probe advancement element 44 can be coupled to the proximal end 36 of the flexible housing 32. Some embodiments of the probe advancement device 30 can include a probe 46 extending in a distal direction within the flexible housing 32. In some embodiments, the flexible housing 32 can be configured to collapse along the axis 42 in response to the probe 46 being advanced in the distal direction.

[0069] In some embodiments, the method can include coupling the blood collection device 60 to the probe advancement device 30. In some embodiments, the probe 46 can be translated in the distal direction to form a fluid path through the catheter assembly 62. Finally, in some embodiments, the blood collection device 60 can be actuated to collect blood from the patient via the fluid path.

[0070] Referring now to FIG. 2, a cross-sectional view of the probe advancement device 30 is shown. In some embodiments, the probe advancement device 30 can include a flexible housing 32 having a proximal end 36 and a distal end 38. In some embodiments, the flexible housing 32 can include a probe 46 extending between the proximal end 36 and the distal end 38. In some embodiments, the probe 46 can include a guidewire. In other embodiments, the probe 46 can include a tube. FIG. 3 In some embodiments, an alignment mechanism 58 can be disposed within the flexible housing 32 to maintain alignment between the proximal end 36 and the distal end 38 of the flexible housing 32. In some embodiments, a first end 59 of the alignment mechanism 58 can be slidably coupled to the probe advancement element 44. In some embodiments, a second end 61 of the alignment mechanism 58 can be coupled to the end connector 54. In some embodiments, the end connector 54 can include an adapter 80 or can be coupled to an adapter 80 to form a fluid path between the probe advancement device 30 and the catheter assembly 62 or other device. In some embodiments, the adapter 80 can include a male luer or other suitable adapter.

[0071] As shown, in some embodiments, the alignment mechanism 58 can include a rigid or elastic rod or other suitable structure that extends along or parallel to the axis 42 between the probe advancement element 44 and the end connector 54. In this way, in some embodiments, when the flexible housing 32 is compressed to advance the probe 46, the probe advancement element 44 can slide in the distal direction along the alignment mechanism 58. Similarly, in some embodiments, when the probe 46 is retracted, the probe advancement element 44 can slide in the proximal direction along the alignment mechanism 58.

[0072] Referring now to FIG. 4 In some embodiments, the probe 46 can include a guidewire, which can include various shapes to facilitate thrombus removal. In some embodiments, the guidewire can include a straight portion and / or a spiral portion. In some embodiments, the distal end of the guidewire can include a ball or other blunt element to avoid damage to the vein.

[0073] In some embodiments, the access grip element 52 can include a pinch element, which can be configured to pinch the probe 46 similar to a clothespin or other pinch mechanism. In some embodiments, the opposing sides of the pinch element can be brought together by the user to pinch the probe 46, which can facilitate its advancement when its path is obstructed.

[0074] In some embodiments, the shaft 81 of the male luer of the probe advancement element 44 can be long enough to reach the interior of the adapter 80 from the access grip element 52 (with the flexible housing 32 compressed) to seal the probe advancement device 30. In some embodiments, the space between the opposing sides of the pinch element can be large enough to allow the shaft 81 to pass through or greater than the width of the shaft 81. In some embodiments, blood can flow proximally through the probe advancement device 30 and proximally through the shaft 81 for collection. In some embodiments, the probe 46, which can include a guidewire, can extend from the shaft 81 and / or can be bent to align with the longitudinal axis of the probe advancement device 30.

[0075] Referring now to FIG. 5In some embodiments, the probe advancement device 30 can include one or more support elements 51a-c (which can be collectively referred to as "support elements 51" in this disclosure) that can be disposed within the flexible housing 32, between the end connectors 54 at the proximal end 36 and the distal end 38. In some embodiments, each support element 51 can include a mating and sealing luer. In more detail, in some embodiments, the distal end of each support element 51 can include a male luer, and the proximal end of each support element 51 can include a female luer. In some embodiments, the support elements 51 can thus be configured to be coupled together. In some embodiments, the distal end of a first support element 51 can be coupled to the proximal end of a second support element 51 that is immediately distal to the first support element 51. In some embodiments, the proximal end of the first support element 51 can be coupled to the distal end of a third support element 51 that is immediately proximal to the first support element 51. In some embodiments, the probe 46 can extend through the support elements 51, which can support the probe 46 and reduce buckling during advancement of the probe 46 in the distal direction.

[0076] In some embodiments, each of the support elements 51 can be configured to lock and unlock. In some embodiments, the support elements 51 can be configured to lock in response to a pinch by a user similar to the proximal access grip element 52. In some embodiments, when a particular support element 51 is locked, the particular support element 51 can pinch the probe 46 such that movement of the particular support element 51 moves the probe 46. In some embodiments, when a particular support element 51 is unlocked, the particular support element 51 can not pinch the probe 46 and can allow the probe 46 to slide through the particular support element 51. In some embodiments, a third support element 51 can be locked and advanced distally and / or coupled to a first support element 51 that can be unlocked. In some embodiments, the first support element 51 can then be locked, the third support element 51 can be unlocked, and subsequently the first support element 51 and the probe 46 are advanced distally. In some embodiments, the first support element 51 can be advanced distally to and / or coupled together with a second support element 51. In some embodiments, the first support element 51 can be unlocked, the second support element 51 can be locked, and subsequently the second support element 51 and the probe 46 are advanced distally. In some embodiments, the support elements 51 can facilitate advancement of the probe 46 when the probe 46 encounters an obstruction that inhibits advancement.

[0077] In some embodiments, the support element 51 can provide several advantages, including supporting the probe 46 at various points along the length of the probe 46, which can reduce buckling during advancement of the probe 46. In addition, in some embodiments, the support element 51 between the distal end 38 and the proximal end 36 can reduce blood flow through the flexible housing 32. In some embodiments, because blood can have difficulty passing through the support element 51, fewer (or no) septums can be provided within the adapter 80, which can reduce resistance on the probe 46 as it is advanced. In some cases, resistance created by septums can increase the likelihood of buckling of the probe 46.

[0078] Referring now to FIG. 6A , FIG. 6B and FIG. 6C , in some embodiments, a septum 88 (or multiple septums 88) can be disposed within the adapter 80. In some embodiments, the septum 88 can facilitate adjustment of the probe 46 after initial placement into the catheter 72 or through the catheter (see, e.g., FIG. 1B ). As shown in FIG. 6A , in some embodiments, the shaft 81 and / or the probe 46 can move through the septum 88 in response to collapse of the flexible housing 32 and movement of the probe 46 in a distal direction. FIG. 6A A probe 46 moving distally through a septum 88 is shown in accordance with some embodiments.

[0079] In some embodiments, the probe 46 can include a tube, for example as shown in FIG. 6A , and can be configured to draw blood when extended through the catheter 72. In some embodiments, the probe 46 can include a guidewire, for example as shown in FIG. 6B , and can extend from and / or be embedded within the shaft 81.

[0080] As shown in FIG. 6C , in some embodiments, the probe 46, which can include a guidewire, can move through the septum 88 in response to collapse of the flexible housing 32 and movement of the probe 46 in a distal direction. In these and other embodiments, the probe 46 can be embedded within the shaft 81 and / or can be off-center. Accordingly, in some embodiments, the septum 88 can include an off-center slit.

[0081] In some embodiments, one or more O-rings 89 can be disposed within the adapter 80 and / or proximal of the septum 88. In some embodiments, the O-rings 89 and / or the elastomeric region 90 of the septum 88 can facilitate movement of the probe 46 between a plurality of different axial positions while also facilitating support and fluidic sealing of the probe 46. In some embodiments, the O-rings and the elastomeric region 90 can form a seal around the tube or shaft 81.

[0082] In some embodiments, the diaphragm 88 may prevent blood from flowing into the lumen surrounded by the flexible housing 32 before and during the advancement of the probe 46. In some embodiments, the diaphragm 88 may also prevent blood from flowing into the lumen surrounded by the flexible housing 32 during the residence of the catheter 72 as the probe 46 extends through the catheter and / or during the retraction of the probe 46. In some embodiments, the diaphragm 88 may provide a seal between the shaft 81 and the adapter 38, which may facilitate the application of aspiration for blood collection when the probe 46 is a guidewire. In some embodiments, the seal provided by the diaphragm 88 between the shaft 81 and the adapter 38 may provide sufficient retention to allow the user to release the proximal end 36 and adjust the position of the probe 46, such as by axial advancement, while the user is drawing blood via the blood collection device 60. In some embodiments, if there is an obstruction in the fluid passage into the probe 46 or the tubing, adjusting the position of the probe 46 may open the fluid passage and facilitate blood flow through the probe 46 and / or into the blood collection device 60.

[0083] like FIG. 6A-FIG. 6E As shown, the shape of diaphragm 88 can be changed. Now refer to FIG. 6D-FIG. 6E The inner surface of the diaphragm 88 may include ridges 91 and / or other ridges 93 that can provide a function similar to that of the O-ring 89 and the elastomer region 90. More specifically, the ridges 91 and / or other ridges 93 may form a seal around the probe 46 or shaft 81, and / or may support the probe 46 or shaft 81. In some embodiments, the ridge 91 may be on one side of a folded portion of the diaphragm, while the other ridges 93 may be on the opposite side of the folded portion. In some embodiments, the folded portion may perform the same or similar function as the elastomer region 90 and may provide a seal around the shaft 81. In some embodiments, the proximal end of the diaphragm 88 may include an inlet or tapered portion 95 to facilitate guiding the probe 46. In some embodiments, the diaphragm 88 may include an H-shaped cross-section, and the H-shaped cross-section and the middle portion of the diaphragm 88 may open in response to movement of the shaft 81 and / or the probe 46 through the diaphragm 88, as... FIG. 6D-FIG. 6E As shown. In these embodiments, the middle portion can be folded 90 degrees toward the elastomer region.

[0084] Now for reference FIG. 7A-FIG. 7EIn some embodiments, the proximity access gripping element 52 can include a resilient material with a hinge 86 such that the proximity access gripping element 52 can be configured to grasp or pinch the probe 46 between the first end 74 and the second end 76. In some embodiments, the hinge 86 can be formed to have a spring tendency to hold the first end 74 and the second end 76 in an open position. In some embodiments, the proximity access gripping element 52 can include a biasing mechanism integrated therewith or coupled thereto to hold the open position between the first end 74 and the second end 76. In some embodiments, the proximity access gripping element 52 can be visible through the flexible housing 32 and can include a size and shape to facilitate viewing and / or manipulation of the proximity access gripping element 52 through the flexible housing 32.

[0085] In some embodiments, the proximity access gripping element 52 can be actuated to grasp the probe 46 in the event that advancement of the probe 46 is impeded. In some embodiments, the proximity access gripping element 52 and the probe 46 can be manually translated in the distal direction to move the probe 46 to overcome or bypass the obstacle. In some embodiments, the probe advancement element 44 and / or the proximity access gripping element 52 can further advance the probe 46 after passing or otherwise overcoming the obstacle. In some embodiments, the probe advancement element 44 and / or the proximity access gripping element 52 can also be used to retract the probe 46 in the proximal direction within the flexible housing 32.

[0086] It can be appreciated that embodiments of one or more of FIGS. 1-7 can be combined. For example, FIG. 1A The probe advancement device 30 of FIG. 1 can be similar or identical to the probe advancement device 30 of FIG. 1B FIG. 2 in one or more features and / or operations. As another example, FIG. 1A The probe advancement device 30 of FIG. 1 can be similar or identical to the probe advancement device 30 of FIG. 3 FIG. 2 in one or more features and / or operations. As another example, FIG. 4 The probe advancement device 30 of FIG. 1 can be similar or identical to the probe advancement device 30 of

[0087] All examples and conditional language recited herein are intended to be construed to teach solely the means for accomplishing the stated examples and conditions and are not intended to limit the scope of the invention to only those examples and conditions. While the embodiments of the present invention have been described in detail, it should be apparent that various modifications, substitutions, and alterations can be made to the embodiments without departing from the spirit and scope of the present invention.

Claims

1. A probe advancement device configured to be coupled to a catheter assembly, characterized in that, The probe advancement device comprises: a flexible housing comprising a proximal end and a distal end; a probe advancement element coupled to the proximal end of the flexible housing, the probe advancement element comprising a probe extending within the flexible housing in a distal direction, wherein the flexible housing is configured to collapse along an axis in response to the probe being advanced in the distal direction; at least one support element disposed within the flexible housing, wherein the probe extends through the support element, and wherein a distal end of the support element comprises a male luer and a proximal end of the support element comprises a female luer.

2. The probe advancement device of claim 1, wherein, The probe comprises one of a guidewire and a tube.

3. The probe advancement device of claim 1, wherein, A proximal end of the probe advancement element is configured to be coupled to a blood collection device.

4. The probe advancement device of claim 1, wherein, The at least one support element comprises a plurality of support elements spaced apart within the flexible housing, wherein the probe extends through the plurality of support elements, wherein a distal end of each support element comprises a male luer and a proximal end of each support element comprises a female luer, wherein the plurality of support elements reduces an amount of blood flowing proximally through the flexible housing.

5. The probe advancement device of claim 4, wherein, Further comprising an adapter disposed at a distal end of the flexible housing and configured to be coupled to a catheter assembly, wherein no septum is disposed within the adapter.

6. The probe advancement device of claim 4, wherein, Each of the plurality of support elements is configured to lock onto the probe.

7. The probe advancement device of claim 1, wherein, Further comprising an end connector disposed at a distal end of the flexible housing and another connector disposed at a proximal end of the flexible housing, wherein the end connector is configured to be coupled to the other connector in response to the probe being advanced in the distal direction and the collapse of the flexible housing.

8. The probe advancement device of claim 7, wherein, The end connector comprises a female luer adapter and the other connector comprises a male luer adapter.

9. The probe advancement device of claim 7, wherein, Further comprising an alignment rod disposed within the flexible housing to maintain alignment between the probe advancement element and the end connector.

10. The probe advancement device of claim 1, wherein, At least a portion of the flexible housing is transparent such that the probe is visible through the flexible housing.

11. The probe advancement device of claim 1, wherein, Further comprising a biasing member disposed within the flexible housing between the probe advancement element and the distal end of the flexible housing, wherein the biasing member is configured to bias the probe in a retracted position.

12. The probe advancement device of claim 11, wherein, The probe advancement element is configured to compress the biasing member in a distal direction in response to the probe being advanced in the distal direction to collapse the flexible housing along the axis.

13. The probe advancement device of claim 1, wherein, Further comprising a proximal access gripping element disposed within the flexible housing toward the proximal end, wherein the proximal access gripping element comprises a first end and a second end configured to be elastically pinched together such that the probe is held between the first end and the second end.

14. The probe advancement device of claim 13, wherein, The proximal access gripping element is configured to be selectively translated within the flexible housing along or parallel to the axis.

15. A probe propulsion system characterized by, comprises: a blood collection device; a flexible housing comprising a proximal end and a fluid passageway extending through the flexible housing; and a probe advancement element coupled to the proximal end of the flexible housing, the probe advancement element comprising a probe extending within the flexible housing in a distal direction, wherein the flexible housing is configured to collapse along an axis in response to the probe being advanced in the distal direction. a probe advancement element disposed at the proximal end and coupled to the blood collection device, the probe advancement element including a probe extending within the flexible housing in a distal direction, wherein the fluid passageway is in fluid communication with the blood collection device; at least one support element disposed in the flexible housing; and a catheter assembly coupled to a distal end of the flexible housing and in fluid communication with the fluid passageway, the catheter assembly configured to receive the probe therethrough, wherein the probe extends through the at least one support element, and wherein a distal end of the at least one support element includes a male luer and a proximal end of the at least one support element includes a female luer.

16. The probe advancement system of claim 15, wherein, the fluid passageway is configured to collapse along an axis of the flexible housing in response to the probe being advanced in the distal direction.

17. The probe advancement system of claim 15, wherein, the probe includes a tube, wherein the fluid passageway extends through the tube.

18. The probe advancement system of claim 17, wherein, the proximal end of the flexible housing includes a connector, wherein the connector includes a shaft, wherein the tube extends distally from the shaft.

19. The probe advancement system of claim 18, wherein, the distal end of the flexible housing includes an end connector, wherein the shaft is configured to be inserted into the end connector to form a fluid-tight seal.

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