Probe advancement device, related system, and method

Abstract

The probe advancement device may be configured to couple to a catheter assembly. The probe advancement device may include a flexible housing, which may include a proximal end and a distal end. The probe advancement device may include a probe advancement element coupled to the proximal end of the flexible housing. The probe advancement element may include a probe extending distally within the flexible housing. The flexible housing may be configured to collapse along an axis in response to the probe being advanced distally. The probe may include a tube for blood collection, a guidewire, or other suitable element.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application Serial No. 63 / 135,377, filed on January 8, 2021, entitled "Probe Advancement Devices and Related Systems and Methods", the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] Background Catheters are generally used to inject fluids into a patient's vasculature. For example, catheters may be used to inject normal saline, various pharmaceuticals, or total parenteral nutrition. Catheters may also be used to draw blood from a patient.

[0003] Catheters may include over - the - needle peripheral intravenous (IV) catheters. In this case, the catheter may be mounted on a introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the needle bevel faces away from the patient's skin. The catheter and the introducer needle are inserted as a whole into the patient's vasculature at a shallow angle from the skin.

[0004] To confirm proper placement of the introducer needle and / or catheter within the blood vessel, the operator generally checks for a "flash - back" of blood in the flash - back chamber of the catheter assembly that includes the catheter. After the needle placement is confirmed, the operator may remove the needle and leave the catheter in place for future blood aspiration or fluid injection.

Summary of the Invention

Problems to be Solved by the Invention

[0005] A catheter typically provides an access port, which may allow other devices to access the catheter while it is in place in the patient's vascular system. These other devices may be employed to perform a variety of tasks, such as obtaining blood samples, injecting fluids, performing measurements, and monitoring. Often, the catheter of an IV catheter device can become occluded (e.g., due to a thrombus or fibrin sheath), which can prevent such tasks from being performed. If a catheter becomes occluded, the practitioner may attempt to remove the occlusion by inserting a needle, wire, or other structure through the catheter. However, removing occlusions with currently available techniques is not always effective, is often difficult to perform, and can cause trauma to the patient's vascular system.

[0006] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or embodiments that operate only in the environment described above. Rather, this background is provided merely to illustrate an example of the technical field in which some of the embodiments described herein may be implemented.

[0007] overview This disclosure, as a whole, relates not only to probe advancement devices that facilitate the advancement of a probe within a catheter, but also to related systems and methods. In some embodiments, a probe advancement device may be employed to perform a variety of tasks, including obtaining a blood sample. Often, the catheter of an IV catheter device becomes occluded (e.g., due to a thrombus or fibrin sheath), which can prevent successful blood aspiration. In some embodiments, the probe may be advanced by a probe advancement device to remove the occlusion or provide a path through the occlusion.

[0008] In some embodiments, the probe advancer may be configured to be coupled to a catheter assembly. In some embodiments, the probe advancer may include a flexible housing, which may include a proximal end and a terminal end. In some embodiments, the probe advancer element may be coupled to the proximal end of the flexible housing. In some embodiments, the probe advancer element may include a probe that extends terminally within the flexible housing. In some embodiments, the flexible housing may be configured to collapse along its axis in response to the probe being advanced terminally.

[0009] In some embodiments, the probe may include either a guidewire or a tube. In some embodiments, the proximal end of the probe advancement element may be configured to be coupled to a blood collection device.

[0010] In some embodiments, the probe advancement device may include a support element located within a flexible housing. In some embodiments, the terminal end of the support element may be equipped with a male luer, and the proximal end of the support element may be equipped with a female luer. In some embodiments, the probe may extend through the support element.

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

[0012] In some embodiments, the end connector may be located at the terminal end of the flexible housing, and another connector may be located at the base end of the flexible housing. In some embodiments, the end connector may be configured to couple to the other connector in response to the probe advancing terminally and the flexible housing collapsing. In some embodiments, the end connector may include a female Luer adapter, and the other connector may include a male Luer adapter.

[0013] In some embodiments, the probe advancement device may include an alignment rod located within a 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 may be transparent so that the probe is visible through the flexible housing.

[0014] In some embodiments, the probe advancement device may include a bias member positioned within the flexible housing between the probe advancement element and the end end of the flexible housing. In some embodiments, the bias member may be configured to bias the probe to the retracted position. In some embodiments, the probe advancement element may be configured to compress the bias member in the end direction in response to the probe being advanced in the end direction, thereby crushing the flexible housing along its axis.

[0015] In some embodiments, the probe advancement device may include a proximity access gripping element positioned within the flexible housing toward the terminal end of the flexible housing. In some embodiments, the proximity access gripping element may be configured to manipulate the position of the probe within the flexible housing. In some embodiments, the proximity access gripping element may include a first end and a second end configured to elastically clamp together, with the probe held between them. In some embodiments, the proximity access gripping element may be configured to selectively translate along or parallel to an axis within the flexible housing.

[0016] In some embodiments, the probe advancement system may include a blood collection device, a flexible housing, and a probe advancement element. In some embodiments, a fluid path may extend through the flexible housing and / or into the blood collection device. In some embodiments, the probe advancement system may include a catheter assembly, which may be coupled to the terminal end of the flexible housing and in fluid communication with the fluid path. In some embodiments, the catheter assembly may be configured to receive the probe through it.

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

[0018] In some embodiments, the method for advancing the probe for blood aspiration may include coupling a probe advancer to a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, which may include a proximal end, a terminal end, and a lumen extending therethrough. In some embodiments, the catheter assembly may include a catheter extending from the terminal end of the catheter adapter, which may be intravenous. In some embodiments, the method may include coupling a blood collection device to the probe advancer. In some embodiments, the probe may be advanced terminally to form a fluid path through the catheter assembly. In some embodiments, after the probe has been advanced terminally, the blood collection device may be activated to collect blood from the patient through the fluid path.

[0019] It should be understood that both the general description above and the detailed description below are illustrative and descriptive, and do not limit the invention as described in the claims. It should also be understood that the various embodiments are not limited to the arrangements and fixtures shown in the drawings. Furthermore, embodiments may be combined, or other embodiments may be utilized, and structural modifications may be made without departing from the scope of the various embodiments of the invention, unless otherwise claimed. Therefore, the detailed description below should not be taken as restrictive.

[0020] Brief explanation of the drawing Exemplary embodiments will be described in more specific and detail with reference to the accompanying drawings. [Brief explanation of the drawing]

[0021] [Figure 1A] Figure 1A is a perspective view of an exemplary probe advancement device according to several embodiments. [Figure 1B] Figure 1B is an overhead perspective view of an exemplary probe advancement system according to several embodiments. [Figure 2A]FIG. 2A is a cross-sectional view of another exemplary probe advancement device showing an exemplary probe including a tube, according to some embodiments. [Figure 2B] FIG. 2B is a cross-sectional view of another exemplary probe advancement device showing an exemplary probe including a guide wire, according to some embodiments. [Figure 3] FIG. 3 is a perspective view of another example of a probe advancement device, according to some embodiments. [Figure 4] FIG. 4 is a cross-sectional view of another probe advancement device configured according to some embodiments. [Figure 5] FIG. 5 is a cross-sectional side view of an exemplary support element disposed within an exemplary flexible housing, according to some embodiments. [Figure 6A] FIG. 6A is a cross-sectional view of an example of a septum disposed within an exemplary adapter, according to some embodiments. [Figure 6B] FIG. 6B is a cross-sectional view of the septum of FIG. 6A showing another example of a probe, according to some embodiments. [Figure 6C] FIG. 6C is a cross-sectional view of another example of a septum disposed within an adapter, according to some embodiments. [Figure 6D] FIG. 6D is a cross-sectional view of another example of a septum disposed within an adapter, according to some embodiments. [Figure 6E] FIG. 6E is a cross-sectional view of the septum of FIG. 6D showing an example of a probe advanced through the septum, according to some embodiments. [Figure 7A] FIG. 7A is a top perspective view of a proximal access gripping element, according to some embodiments. [Figure 7B] FIG. 7B is a side view of the proximal access gripping element of FIG. 7A. [Figure 7C] FIG. 7C is a perspective view of the proximal access gripping element of FIG. 7A and an exemplary probe, according to some embodiments. [Figure 7D] FIG. 7D is a perspective view of the proximal access gripping element of FIG. 7A actuated to grip a probe, according to some embodiments. [Figure 7E] Figure 7E is a perspective view of the proximity access gripping element of Figure 7A, which is operated to translate the probe through an exemplary septum according to several embodiments. [Modes for carrying out the invention]

[0022] Description of the Embodiment In this specification and in the claims, the term “catheter assembly” should be interpreted as any device including an IV catheter. The term “probe advancer” should be interpreted as any device configured to advance and / or retract a probe within an IV catheter. In some embodiments, the probe advancer may be a separate device from the catheter assembly on which the probe advancer may be used. In other embodiments, the probe advancer may include the catheter assembly or may be formed monolithically as a single unit with the catheter assembly.

[0023] Figures 1A and 1B show a probe advancer 30 for advancing the probe 46 within the catheter 72. In some embodiments, the probe 46 may include a tube through which blood may flow. In other embodiments, the probe 46 may include a guidewire, such as a nickel-titanium guidewire.

[0024] Various embodiments of the probe advancer 30 may be employed to perform various tasks, including, for example, obtaining a blood sample. For example, in some embodiments, the probe advancer 30 may deliver the probe 46 through the catheter assembly 62 to clean a portion of the catheter 72 that is occluded (e.g., due to a thrombus or fibrin sheath). Failure to clean such an occlusion may prevent successful blood aspiration. Some embodiments presented herein may shorten the effective length of the buckling column of the probe 46 and / or reduce the resistance when the probe 46 is advanced to the terminal.

[0025] Referring here to Figure 1A, in a first set of exemplary embodiments, the probe advancement device 30 may include a flexible housing 32 having a proximal end 36 and a terminal end 38. In some embodiments, the flexible housing 32 may include a flexible biocompatible plastic material or other suitable flexible medical-grade polymer, such as one or more of polyethylene, PEEK, polycarbonate, polyetherimide, polysulfone, polypropylene, and polyurethane. In some embodiments, the flexible housing 32 may include a transparent material to facilitate visualization of obstacles and / or the advancement or of the probe 46 therein. In some embodiments, the flexible housing 32 may include an accordion-like structure that forms a collapsible lumen or fluid path. In some embodiments, the flexible housing 32 may be aligned with an axis 42. In some embodiments, the axis 42 may include a central or longitudinal axis of the flexible housing 32, which may extend through the proximal end 36 and the terminal end 38.

[0026] In some embodiments, the probe advancement element 44 may be coupled to the base end of the flexible housing 32. In some embodiments, the probe advancement element 44 may include a rigid or elastic material. In some embodiments, the probe advancement element 44 may include a shape that substantially matches the cross-sectional shape of the flexible housing 32. As shown in the figure, for example, the flexible housing 32 may form a cylinder, while the probe advancement element 44 may form a circle having a diameter that substantially matches the diameter of the cylinder. In this way, in some embodiments, the probe advancement element 44 may substantially close the base end 36 of the flexible housing 32. In some embodiments, the probe advancement element 44 may include any suitable shape for substantially closing the base end 36 of the flexible housing 32.

[0027] In some embodiments, the proximal end 36 of the probe advancer 30 may include a Luer adapter or other coupling feature configured to couple to a corresponding Luer adapter or coupling feature located on the terminal end 38. Thus, in some embodiments, the flexible housing 32 may be compressed or completely compressed by coupling the coupling feature of the proximal end 36 to the corresponding coupling feature of the terminal end 38. In some embodiments, the proximal end 36 of the probe advancer 30 may include a male Luer, which may include a shaft 81 configured to couple to a female Luer on the terminal end 38.

[0028] In some embodiments, the probe 46 may extend terminally from a probe advancement element 44 within a flexible housing 32. In some embodiments, the probe 46 may include a guide wire or a tube. In some embodiments, the tube may be cylindrical. In some embodiments, the flexible housing 32 may be configured to collapse along the axis 42 as the probe 46 is advanced terminally. For example, in some embodiments, the accordion-like structure of the flexible housing 32 may result in a flexible housing 32 having a length that gradually shortens in response to the probe 46 advancing terminally.

[0029] In some embodiments, the probe advancement device 30 may further include a proximity access gripping element 52, as will be described in more detail below. In some embodiments, the proximity access gripping element 52 may be positioned within the flexible housing 32 and / or near the terminal end 38. Some embodiments of the proximity access gripping element 52 may be configured to manipulate the position of the probe 46 within the flexible housing 32. In this way, the probe 46 may advance through part or all of the catheter (see, for example, catheter 72 in Figure 1B) to clear obstacles, thereby facilitating successful blood aspiration.

[0030] In some embodiments, a seal, such as an O-seal or a suitable rubber or plastic seal, may be positioned 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 may be coupled to or integrated with the probe advancement element 44. In these embodiments and other embodiments, the Luer adapter or other coupling feature may form a seal at the proximal end 36. Thus, in some embodiments, the probe 46 may include a guidewire and / or the flexible housing 32 may form an airtight fluid path from which blood can be aspirated using a VACUTAINER® LUER-LOK® access device ("LLAD," available from Becton Dickinson & Company, Franklin Lake, New Jersey), a syringe, or other suitable blood collection device.

[0031] In some embodiments, the probe 46 may include a tube, which may extend from the probe advancement element 44. In some embodiments, when the tube is advanced toward the end through the flexible housing 32, the tube may form a fluid path through which blood can be drawn using a blood collection device 60, such as an LLAD or syringe.

[0032] In some embodiments, the probe 46 may clean an obstruction by moving the tip of the catheter 72, removing a thrombus or other obstruction from the catheter 72, extending a new fluid pathway to a new blood source, suppressing a thrombus, opening one or more valves, and moving the catheter 72 away from the obstruction. In some embodiments, the position and / or placement of the probe 46 may be adjusted after the initial deployment to facilitate cleaning of the pathway for blood aspiration. In some embodiments, the probe advancer 30 may provide the user with tactile and / or auditory feedback indicating that the initial advance of the probe 46 is complete.

[0033] Referring here to Figure 1B, the probe advancement system 78 may include a blood collection device 60, a probe advancement device 30, and a catheter assembly 62. In some embodiments, the catheter assembly 62 may include a catheter adapter 64 having a proximal end 68, a terminal end 70, and a catheter 72 extending from the terminal end 70. In some embodiments, an extension tube 66 may extend from a side port of the catheter adapter 64. Figure 1B shows the probe advancement system 78 in some embodiments, immediately before the male Luer is inserted into the proximal end 68 or connector 69 to connect the probe advancement device 30 to the catheter assembly 62.

[0034] In some embodiments, the probe advancement element 44 may be located at the proximal end 36 of the flexible housing 32 and coupled to the blood collection device 60. In some embodiments, the probe advancement element 44 may include a probe 46 that extends terminally within the flexible housing 32. In some embodiments, the flexible housing 32 may be configured to collapse along the axis 42 in response to the probe 46 being advanced terminally.

[0035] In some embodiments of the flexible housing 32, a collapsible fluid path can be formed that is in fluid communication with the blood collection device 60. In these embodiments and other embodiments, blood may flow around the probe 46, which may include a guide wire. In other embodiments, the probe 46 may include a tube, and blood may flow through the tube without flowing between the tube and the inner surface of the flexible housing 32.

[0036] In some embodiments, the probe advancement device 30 may include a connector element 50 located within a flexible housing 32 and configured to connect to an end connector 54 at the end end 38 of the flexible housing 32. In some embodiments, at least a portion of the flexible housing 32 may be transparent so that the probe 46 is visible through the outer surface 34. In some embodiments, the shaft 81 and / or the probe 46 may be configured to mate through a hole in the connector 50 or to connect to a corresponding luer of the connector 50. In some embodiments, the connector 50 may include a circular disk as a whole and / or an extension extending from the circular disk as a whole to the end connector 54, to which the extension may be attached.

[0037] As will be discussed in more detail below, in some embodiments, the proximity access gripping element 52 may be positioned within the flexible housing 32 near the terminal end 38. In some embodiments, the proximity access gripping element 52 may be fixed to an extension of the connector element 50. Some embodiments of the proximity access gripping element 52 may be configured to manipulate the position of the probe 46 within the flexible housing 32.

[0038] In some embodiments, a bias member 56, such as a spring, may extend between the connector element 50 and the base end 36 to bias the probe 46 to a retracted position. In some embodiments, the bias member 56 may be compressed when the probe 46 is advanced toward the terminal. In some embodiments, the bias member 56 may be configured to automatically retract the probe 46 toward the base.

[0039] In some embodiments, the catheter assembly 62 may be coupled to the terminal end 38 of the flexible housing 32. In some embodiments, the catheter assembly 62 may be coupled to the probe advancer 30 and be in fluid communication with a collapsible fluid path and / or a fluid path through the probe 46. In some embodiments, the catheter assembly 62 may be configured to receive the probe 46 through it.

[0040] Referring here to Figures 2A-2B, in some embodiments, advancement of the probe 46 may be achieved by grasping the proximal end 36 of the probe advancer 30 and moving the probe 46 toward and / or distally through the catheter 72. In some embodiments, the proximal end 36 of the probe advancer 30 may include a shape and / or texture that facilitates grasping the proximal end 36 to manipulate the position of the probe 46. In some embodiments, it is understood that one or more features of Figure 2 may be combined with one or more features of Figures 1A and / or 1B. Figure 2A shows the probe 46 as a tube according to some embodiments. In some embodiments, the tube may be fixed in a fluid-tight manner, such as via adhesive or other suitable method. Figure 2B shows the probe 46 as a guidewire, which may be fixed to the shaft 81 via adhesive or other suitable method. In some embodiments, the guidewire may be embedded in the shaft 81. In some embodiments, the guidewire may include various shapes to facilitate thrombectomy. In some embodiments, the guidewire may include a straight portion and / or a helical portion 79. In some embodiments, the end of the guidewire may include a blunt element 81, which may include a ball, a rounded surface, or another blunt element to avoid damage to the vein.

[0041] In some embodiments, the probe 46 may be advanced terminally through the catheter assembly and into the patient's vascular system or vein. In some embodiments, the proximal end 36 of the probe advancer 30 may be rotated or otherwise adjusted to facilitate the flexible housing 32 in order to further advance the probe 46 terminally. In some embodiments, the probe 46 may be advanced terminally until it extends through the catheter 72 (see, for example, Figure 1B).

[0042] In some embodiments, the probe 46 may encounter obstacles that hinder its advancement, such as a thrombus formed inside the tip of the catheter 72 or an S-curve of the catheter 72 that occurs when the catheter 72 is inserted into the skin. In these embodiments, a proximity access gripping element 52 located near the terminal end 38 may be used to support and advance the probe 46. In some embodiments, the proximity access gripping element 52 may be made easier to manipulate by providing a reduced buckling column length.

[0043] In fact, in some embodiments, the probe 46 may have a small moment of inertia when it passes through the catheter 72 or catheter assembly 62. In some embodiments, a portion of the tube or probe 46 may be well supported by the catheter assembly 62 in the extended position, while other portions may not be supported. As a result, these unsupported portions may buckle when an insertion load is applied.

[0044] In this regard, Euler's buckling formula demonstrates: Pcr = pi^2 EI / L^2 Here, the moment of inertia I is equal to I = pi^4 / 4 for solid wires or guide wires, and to I = pi(Ro^4-Ri^4) / 4 for tubes. In some embodiments, the probe 46 must pass through the inner diameter of the catheter 72, so the R value may be very small, resulting in a very flexible column that is prone to buckling. However, in some embodiments, shortening the insertion distance may cause the column to become significantly stiffer to support the required insertion force.

[0045] In some embodiments, the proximity access gripping element 52 may include 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 proximity access gripping element 52 may facilitate the translation of the probe 46. In some embodiments, the proximity access gripping element 52 may include external features that can be felt and / or manipulated by the user through the flexible housing 32. In some embodiments, the proximity access gripping element 52 may further include one or more surfaces configured to interconnect or engage with the probe 46. For example, in some embodiments, the surface may include one or more grooves, recesses, or other textures or materials to facilitate a secure interconnection between the proximity access gripping element 52 and the probe 46.

[0046] In some embodiments, the user may operate the proximity access gripping element 52 to grip at least a portion of the length of the probe 46. In some embodiments, the user may move the proximity access gripping element 52 to move the probe 46. In some embodiments, the proximity access gripping element 52 may be translated or moved along the axis 42 to advance or retract the probe 46 within the catheter 72. In some embodiments, the user may operate the proximity access gripping 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.

[0047] In some embodiments, the end connector 54 may include an adapter 80, which may include a proximal female Luer adapter and / or an end male Luer adapter. In some embodiments, the proximal end 36 of the probe advancer 30 may include a Luer adapter, such as a male Luer as illustrated in Figure 2, which may include a width 57. In some embodiments, in response to the advancement of the probe 46 to the end and the collapse of the flexible housing 32, the male Luer may be configured to insert into the female Luer of the end connector 54 so that the male Luer seals the end connector 54. In some embodiments, the width or shape of the female Luer may accommodate the width or shape of the male Luer. In some embodiments, the male Luer may contact the inner surface of the adapter 80 to form a seal, which may reduce or prevent the flow of fluid through the adapter 80 when the probe 46 is advanced to the end and the flexible housing 32 is collapsed. In some embodiments, the flexible housing 32 may be compressed or completely compressed by coupling the male Luer to the female Luer. In some embodiments, the probe advancement device 30 may not include a septum, which may reduce the resistance of the probe 46. In other embodiments, the probe advancement device 30 may include a septum.

[0048] In some embodiments, the method for advancing the probe 46 for blood aspiration may include coupling a probe advancer 30 (see, for example, Figures 1-7) to a catheter assembly 62 (see, for example, Figure 2B). In some embodiments, the catheter assembly 62 may include a catheter adapter 64 having a proximal end 68, a terminal end 70, and a catheter 72 extending from the terminal end 70.

[0049] Some embodiments of the probe advancement device 30 may include a flexible housing 32 and a probe advancement element 44. In some embodiments, the flexible housing 32 may include a base end 36 and a terminal end 38. In some embodiments, the flexible housing 32 may form a collapsible fluid path between the base end 36 and the terminal end 38 and / or around the probe 46, which may include a guide wire. In other embodiments, as shown in Figure 2, the fluid path may extend through the probe 46, which may include a tube. In these embodiments, the fluid path does not have to extend between the tube and the flexible housing 32.

[0050] In some embodiments, the probe advancement element 44 may be coupled to the proximal end 36 of the flexible housing 32. Some embodiments of the probe advancement device 30 may include a probe 46 extending terminally within the flexible housing 32. In some embodiments, the flexible housing 32 may be configured to collapse along the axis 42 in response to the probe 46 being advanced terminally.

[0051] In some embodiments, the method may include coupling the blood collection device 60 to the probe advancement device 30. In some embodiments, the probe 46 may be translated toward the terminal direction to form a fluid path through the catheter assembly 62. Finally, in some embodiments, the blood collection device 60 may be activated to collect blood from the patient through the fluid path.

[0052] Referring next to Figure 3, in some embodiments, the alignment mechanism 58 may be located within the flexible housing 32 to maintain alignment between the proximal end 36 and the terminal end 38 of the flexible housing 32. In some embodiments, the first end 59 of the alignment mechanism 58 may be slidably coupled to the probe advancement element 44. In some embodiments, the second end 61 of the alignment mechanism 58 may be coupled to the end connector 54. In some embodiments, the end connector 54 may include an adapter 80, or be coupled to the adapter 80 to create a fluid path between the probe advancement device 30 and the catheter assembly 62 or another device. In some embodiments, the adapter 80 may include a male Luer or other suitable adapter.

[0053] As illustrated, in some embodiments, the alignment mechanism 58 may include a rigid or flexible rod or other suitable structure extending along or parallel to the axis 42 between the probe advancement element 44 and the end connector 54. In this manner, in some embodiments, the probe advancement element 44 may slide terminally along the alignment mechanism 58 as the flexible housing 32 is compressed to advance the probe 46. Similarly, in some embodiments, the probe advancement element 44 may slide proximal along the alignment mechanism 58 as the probe 46 is retracted.

[0054] Referring now to Figure 4, in some embodiments, the probe 46 may include a guidewire which may have various shapes to facilitate thrombus removal. In some embodiments, the guidewire may include a straight portion and / or a spiral portion. In some embodiments, the terminal end of the guidewire may include a ball or another blunt element to avoid damage to the vein.

[0055] In some embodiments, the proximity access gripping element 52 may include a clamping element, which may be configured to clamp the probe 46, similar to a clothing pin or other clamping mechanism. In some embodiments, opposing sides of the clamping element may be brought together by the user to clamp the probe 46, which may facilitate its advance if the path of the probe 46 is obstructed.

[0056] In some embodiments, the shaft 81 of the male luer of the probe advancement element 44 may be long enough to reach from the proximity access gripping element 52 to the interior of the adapter 80 (with the flexible housing 32 compressed) and seal the probe advancement device 30. In some embodiments, the space between the opposing sides of the gripping element may be large enough to allow the shaft 81 to pass through, or may be larger than the width of the shaft 81. In some embodiments, blood may flow through the probe advancement device 30 to the proximal end and through the shaft 81 to the proximal end for collection. In some embodiments, the probe 46 may include a guide wire, which may extend from the shaft 81 and / or be bent to align with the longitudinal axis of the probe advancement device 30.

[0057] Referring now to Figure 5, in some embodiments, the probe advancement device 30 may include one or more support elements 51a-c (which may be collectively referred to as “support elements 51” in this disclosure), which may be located within a flexible housing 32 between a proximal end 36 and an end connector 54 at a terminal end 38. In some embodiments, each of the support elements 51 may include a mating lure and a sealing lure. More specifically, in some embodiments, each terminal end of the support elements 51 may include a male lure, and each proximal end of the support elements 51 may include a female lure. In some embodiments, the support elements 51 may be configured to connect to one another. In some embodiments, the terminal end of a first support element 51 may be connected to the proximal end of a second support element 51 that is immediately terminal to the first support element 51. In some embodiments, the proximal end of a first support element 51 may be connected to the proximal end of a third support element 51 that is immediately terminal to the first support element 51. In some embodiments, the probe 46 may extend through a support element 51, which may support the probe 46 and reduce buckling as the probe 46 advances toward the terminal.

[0058] In some embodiments, each of the support elements 51 may be configured to lock and unlock. In some embodiments, the support elements 51 may be configured to lock in response to user gripping, similar to the proximity access gripping elements 52. In some embodiments, when a particular support element 51 is locked, it may grip the probe 46 so that movement of the support element 51 moves the probe 46. In some embodiments, when a particular support element 51 is unlocked, it may not grip the probe 46, allowing the probe 46 to slide through the support element 51. In some embodiments, a third support element 51 may be coupled to a first support element 51 which may be locked relative to the first support element 51 and advanced to the end and / or unlocked. In some embodiments, the first support element 51 may then be locked, the third support element 51 may be unlocked, and subsequently the first support element 51 and the probe 46 may advance to the end. In some embodiments, the first support element 51 may be advanced to the end relative to the second support element 51, and / or coupled together with the second support element 51. In some embodiments, the first support element 51 may then be unlocked, the second support element 51 may be locked, and subsequently the second support element 51 and the probe 46 may advance to the end. In some embodiments, the support element 51 may facilitate the advancement of the probe 46 when the probe 46 encounters an obstacle that hinders its advancement.

[0059] In some embodiments, the support element 51 may provide several advantages, including supporting the probe 46 at various points along the length of the probe 46, which may reduce buckling during the advancement of the probe 46. Also in some embodiments, the support element 51 between the terminal end 38 and the proximal end 36 may reduce the amount of blood flowing through the flexible housing 32. In some embodiments, there may be fewer (or no) septums positioned within the adapter 80, as it may be difficult for blood to pass through the support element 51, which may reduce the tension on the probe 46 as it is advanced. In some embodiments, the tension caused by the septum may increase the likelihood of buckling of the probe 46.

[0060] Referring here to Figures 6A, 6B, and 6C, in some embodiments, a septum 88 (or multiple septums 88) may be located within the adapter 80. In some embodiments, the septum 88 may facilitate adjustment of the probe 46 after its initial placement into or through the catheter 72 (see, for example, Figure 1B). As shown in Figure 6A, in some embodiments, the shaft 81 and / or the probe 46 may move through the septum 88 in response to the collapse of the flexible housing 32 and the terminal movement of the probe 46. Figure 6A shows the probe 46 moving terminally through the septum 88 according to some embodiments.

[0061] In some embodiments, the probe 46 may include a tube, as illustrated in Figure 6A, for example, and may be configured to aspirate blood when it extends through the catheter 72. In some embodiments, the probe 46 may include a guidewire, as illustrated in Figure 6B, for example, and may extend from and / or be embedded in the shaft 81.

[0062] As shown in Figure 6C, in some embodiments, in response to the deformation of the flexible housing 32 and the movement of the probe 46 toward the end, the probe 46, which may include a guide wire, may move through the septum 88. In these embodiments and other embodiments, the probe 46 may be embedded in the shaft 81 and / or off-center. Therefore, in some embodiments, the septum 88 may include an off-center slit.

[0063] In some embodiments, one or more O-rings 89 may be located within the adapter 80 and / or at the proximal end of the septum 88. In some embodiments, the elastomer region 90 of the O-rings 89 and / or the septum 88 may facilitate support for the probe 46 and fluid sealing while facilitating the movement of the probe 46 between a number of different axial positions. In some embodiments, the O-rings and elastomer region 90 may form a seal around the tube or shaft 81.

[0064] In some embodiments, the septum 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 septum 88 may also prevent blood from flowing into the lumen surrounded by the flexible housing 32 while the probe 46 is in the position of the catheter 72 that penetrates and extends through it, and / or during the retraction of the probe 46. In some embodiments, the septum 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 between the shaft 81 and the adapter 38 provided by the septum 88 may generate sufficient retention, allowing the user to release the proximal end 36 while the user is aspirating blood through the blood collection device 60 and adjusting the position of the probe 46, such as through axial advancement. In some embodiments, if there is an obstruction in the fluid pathway flowing into the probe 46 or the tube, adjusting the position of the probe 46 may open the fluid pathway and facilitate the flow of blood into the probe 46 and / or the blood collection device 60.

[0065] As shown in Figures 6A-6E, the shape of the septum 88 may vary. Referring here to Figures 6D-6E, the inner surface of the septum 88 may include a bump 91 and / or other bumps 93, which may provide a function similar to that of the O-ring 89 and the elastomer region 90. More specifically, the bump 91 and / or other bumps 93 may form a seal around the probe 46 or shaft 81 and / or support the probe 46 or shaft 81. In some embodiments, the bump 91 may be on one side of the folded portion of the septum, and the other bump 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 provide a seal around the shaft 81. In some embodiments, the proximal end of the septum 88 may include a lead-out or tapered portion 95 to facilitate guidance of the probe 46. In some embodiments, the septum 88 may include an H-shaped cross-section, as illustrated in Figures 6D-6E, and the intermediate portion of the H-shaped cross-section and the septum 88 may open in response to the shaft 81 and / or probe 46 moving through the septum 88. In these embodiments, the intermediate portion may fold toward the elastomer region 90.

[0066] Referring here to Figures 7A-7E, in some embodiments, the proximity access gripping element 52 may include an elastic material having a hinge 86, configured to grip or clamp the probe 46 between a first end 74 and a second end 76. In some embodiments, the hinge 86 may be formed to have a spring tendency to maintain the first end 74 and the second end 76 in an open position. In some embodiments, the proximity access gripping element 52 may include a bias mechanism integrated with or coupled to it to maintain the open position between the first end 74 and the second end 76. In some embodiments, the proximity access gripping element 52 may be visible through the flexible housing 32 and may include a size and shape that facilitates viewing and / or operating the proximity access gripping element 52 through the flexible housing 32.

[0067] In some embodiments, if the advance of the probe 46 is obstructed, the proximity access gripping element 52 may be actuated to grip the probe 46. In some embodiments, the proximity access gripping element 52 and the probe 46 may be manually translated toward the terminal to move the probe 46 over or around an obstacle. In some embodiments, the probe advance element 44 and / or the proximity access gripping element 52 may advance the probe 46 further after passing or otherwise overcoming an obstacle. In some embodiments, the probe advance element 44 and / or the proximity access gripping element 52 may be used to retract the probe 46 toward the proximal end within the flexible housing 32.

[0068] It is understood that one or more embodiments of Figures 1 to 7 may be combined. For example, the probe advancement device 30 of Figure 1A may be similar to or identical to the probe advancement device 30 of Figure 1B in terms of one or more features and / or operation. As another example, the probe advancement device 30 of Figure 1A may be similar to or identical to the probe advancement device 30 of Figure 2 in terms of one or more features and / or operation. As yet another example, the probe advancement device 30 of Figure 3 may be similar to or identical to the probe advancement device 30 of Figure 4 in terms of one or more features and / or operation.

[0069] All embodiments and conditional statements incorporated herein are intended for educational purposes to help the reader understand the concepts to which the inventors have contributed to further the invention and the art, and are construed as not being limited to such specifically incorporated embodiments and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made herein without departing from the spirit and scope of the invention.

Claims

1. A probe advancement device configured to be coupled to a catheter assembly, wherein the probe advancement device is A flexible housing having a base end and a terminal end, A probe advance element coupled to the base end of the flexible housing, wherein the probe advance element comprises a probe extending in the terminal direction within the flexible housing, and the flexible housing is configured to collapse along its axis in response to the probe advancing in the terminal direction, and A support element disposed within the flexible housing, wherein the probe extends through the support element, the distal end of the support element is provided with a male luer, and the proximal end of the support element is provided with a female luer. A probe advancement device equipped with the above.

2. The probe advancement device according to claim 1, wherein the probe comprises one of a guide wire and a tube.

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

4. A probe advancement device configured to be coupled to a catheter assembly, wherein the probe advancement device is A flexible housing having a base end and a terminal end, A probe advance element coupled to the base end of the flexible housing, wherein the probe advance element comprises a probe extending in the terminal direction within the flexible housing, and the flexible housing is configured to collapse along its axis in response to the probe advancing in the terminal direction, and A plurality of support elements spaced apart within the flexible housing, the probe extending through the plurality of support elements, each of the terminal ends of the support elements having a male luer, each of the proximal ends of the support elements having a female luer, and the plurality of support elements reducing the amount of blood flowing through the flexible housing to the proximal end, A probe advancement device equipped with the above.

5. The probe advancement device according to claim 1 or 4, further comprising an adapter positioned at the terminal end of the housing and configured to connect to a catheter assembly, wherein no septum is located within the adapter.

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

7. The probe advancing device according to claim 1, further comprising an end connector located at the terminal end of the flexible housing and another connector located at the base end of the flexible housing, wherein the end connector is configured to connect to the other connector in response to the probe being advanced in the terminal direction and the flexible housing being compressed.

8. The probe advancement device according to claim 7, wherein the end connector is equipped with a female Luer adapter and the other connector is equipped with a male Luer adapter.

9. A probe advancement device configured to be coupled to a catheter assembly, wherein the probe advancement device is A flexible housing having a base end and a terminal end, A probe advance element coupled to the base end of the flexible housing, wherein the probe advance element comprises a probe extending in the terminal direction within the flexible housing, and the flexible housing is configured to collapse along its axis in response to the probe advancing in the terminal direction. An end connector located at the end end of the flexible housing, and another connector located at the base end of the flexible housing, wherein the end connector is configured to connect to the other connector in response to the probe being advanced toward the end and the flexible housing being compressed, and An alignment rod disposed within the flexible housing to maintain alignment between the probe advance element and the end connector, A probe advancement device equipped with the above.

10. The probe advancing device according to claim 1, wherein at least a portion of the flexible housing is transparent, and the probe is visible through the flexible housing.

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

12. The probe advancing device according to claim 11, wherein the probe advancing element is configured to compress the bias member in the terminal direction in response to the probe being advanced in the terminal direction, thereby crushing the flexible housing along the axis.

13. The probe advancement device according to claim 1, further comprising a proximity access gripping element disposed within a flexible housing toward the terminal end, wherein the proximity access gripping element has a first end and a second end configured to be elastically clamped together, and the probe is held between them.

14. The probe advancing device according to claim 13, wherein the proximity access gripping element is configured to selectively translate along or parallel to the axis within the flexible housing.

15. A probe advancement system, Blood collection device, A flexible housing comprising a base end and a fluid path extending through it, and A probe advance element positioned at the proximal end and coupled to the blood collection device, wherein the probe advance element comprises a probe extending in the terminal direction within the flexible housing, and the fluid path is in fluid communication with the blood collection device, A support element disposed within the flexible housing, wherein the probe extends through the support element, the terminal end of the support element is provided with a male lure, and the base end of the support element is provided with a female lure, and A catheter assembly coupled to the terminal end of the flexible housing and in fluid communication with the fluid path, wherein the catheter assembly is configured to receive the probe through it, A probe advancement system equipped with the following features.

16. The probe advancement system according to claim 15, wherein the fluid path is configured to collapse along the axis of the flexible housing in response to the probe being advanced toward the terminal.

17. The probe advancement system according to claim 15, wherein the probe comprises a tube and the fluid path extends through the tube.

18. The probe advancement system according to claim 17, wherein the base end of the flexible housing is provided with a connector, the connector is provided with a shaft, and the tube extends from the shaft to its end.

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

20. A probe advancement system, Blood collection device, A flexible housing comprising a base end and a fluid path extending through it, and A probe advance element positioned at the proximal end and coupled to the blood collection device, wherein the probe advance element comprises a probe extending in the terminal direction within the flexible housing, and the fluid path is in fluid communication with the blood collection device, A plurality of support elements spaced apart within the flexible housing, the probe extending through the plurality of support elements, each of the terminal ends of the support elements having a male luer, each of the proximal ends of the support elements having a female luer, and the plurality of support elements reducing the amount of blood flowing through the flexible housing to the proximal end, and A catheter assembly coupled to the terminal end of the flexible housing and in fluid communication with the fluid path, wherein the catheter assembly is configured to receive the probe through it, A probe advancement system equipped with the following features.

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