Vascular Device Insertion System and Equipment

Abstract

The present invention relates to a vascular device insertion system, comprising a support catheter having a seat, a flexible, slender member extending distally from the seat, and a catheter lumen extending through the seat and the flexible, slender member. The insertion module housing is configured to accommodate a motor having a hollow motor shaft. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongated opening extending from the proximal end to the distal end. The distal end portion of the hollow motor shaft is configured to be coupled to the seat of the support catheter. The elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous channel. The motor controller is electrically coupled to the motor and configured to cause the hollow motor shaft to rotate and oscillate so as to thereby cause the support catheter to rotate and oscillate.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] none. Technical Field

[0003] The present invention relates to vascular access devices, and more particularly to vascular device insertion systems and apparatus. Background Art

[0004] Some vascular surgeries require placement of a guidewire in the blood vessel as an initial step in the vascular surgery. However, sometimes it can be difficult for the doctor to manually maneuver the guidewire through the blood vessel, such as in areas where the blood vessel is partially or completely occluded.

[0005] There is a need in the art for vascular device insertion systems and apparatus that can be used to facilitate the insertion and placement of guidewires and / or vascular catheters within a blood vessel. Summary of the Invention

[0006] The present invention provides vascular device insertion systems and apparatus that can be used to facilitate the insertion and placement of a guidewire and / or a vascular catheter in a blood vessel.

[0007] In one form, the present invention is directed to a vascular device insertion system. The system includes a support catheter, an insertion module housing that houses a motor, and a motor controller. The support catheter has a seat, a flexible, slender member extending distally from the seat, and a catheter lumen extending through the seat and the flexible, slender member. The motor has a hollow motor shaft arranged along a longitudinal axis. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongated opening extending from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft is configured to be coupled to the seat of the support catheter. The elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous channel. The motor controller is electrically coupled to the motor. The motor controller is configured to control the motor to cause the hollow motor shaft to rotate and oscillate about the longitudinal axis and thereby cause the support catheter to rotate and oscillate.

[0008] In another embodiment, the present invention is directed to a vascular device insertion system. The system includes a support catheter, an insertion module housing housing a motor, a guidewire, and a motor controller. The support catheter has a seat, a flexible, elongated member extending distally from the seat, and a catheter lumen extending through the seat and the flexible, elongated member. The motor has a hollow motor shaft arranged along a longitudinal axis. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongated opening extending from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft is configured to couple to the seat of the support catheter. The elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous channel. The guidewire has a first end and a second end. The guidewire is positioned in the continuous channel defined by the elongated opening in the hollow motor shaft and the catheter lumen of the support catheter, with the first end portion of the guidewire proximal to the proximal end of the hollow motor shaft. The continuous channel is configured so that the guidewire can be freely manually moved within the continuous channel by manually manipulating the first end portion of the guidewire. The motor controller is electrically coupled to the motor. The motor controller is configured to rotationally oscillate the hollow motor shaft about the longitudinal axis to thereby rotationally oscillate the support conduit.

[0009] In yet another form, the present invention is directed to a vascular device insertion apparatus for advancing a support catheter and a guidewire in a blood vessel. The support catheter has a seat, a flexible, elongated member extending distally from the seat, and a catheter lumen extending through the seat and the flexible, elongated member. The vascular device insertion apparatus includes an insertion module housing configured to house a motor having a hollow motor shaft arranged along a longitudinal axis. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongated opening extending from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft is configured to couple to the seat of the support catheter. The elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous channel. The continuous channel is configured to receive the guidewire. A motor controller is electrically coupled to the motor. The motor controller is configured to cause the hollow motor shaft to rotate and oscillate about the longitudinal axis so as to thereby cause the support catheter to rotate and oscillate.

[0010] One advantage of the present invention is that the rotational oscillations provided by the motor shaft to the supporting catheter help to longitudinally advance the guidewire through the occlusion in the blood vessel.

[0011] Another advantage of the present invention is that longitudinal reciprocating motion can be applied to the motor simultaneously with rotational oscillation, thereby causing the support catheter to both longitudinally reciprocate and rotationally oscillate within the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The above and other features and advantages of the present invention and the manner in which they are achieved will become more apparent, and the present invention will be better understood, by referring to the following description of the embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0013] Figure 1 is a schematic diagram of a vascular device insertion system of the present invention, which includes a vascular device insertion apparatus and a support catheter that can be used to assist in the insertion and placement of a guidewire and / or a vascular catheter; and

[0014] Figure 2 yes Figure 1 Schematic diagram of a vascular device insertion system comprising a Figure 1 An ultrasound system is used in conjunction with and coupled to the vascular device insertion apparatus and support catheter.

[0015] Corresponding reference characters indicate corresponding parts throughout the several views.The examples set out herein illustrate at least one embodiment of the invention, and such examples should not be construed as limiting the scope of the invention in any way. DETAILED DESCRIPTION

[0016] Referring now to the drawings, and more particularly to the Figure 1 , shows a vascular device insertion system 10, which generally includes a vascular device insertion apparatus 12 and a vascular device 14. The vascular device 14 can be, for example, a support catheter 16, and it can be accompanied by a guidewire 18 and / or a vascular catheter, such as an ultrasonic catheter 20. Figure 1 , the vascular device 14 and the support catheter 16 are arranged along a longitudinal axis 22 .

[0017] Support catheter 16 includes a seat 16-1 and a flexible, elongated member 16-2 extending distally from seat 16-1. A catheter lumen 16-3 extends through seat 16-1 and flexible, elongated member 16-2, i.e., throughout the entire length of support catheter 16. Seat 16-1 includes a mounting aperture 16-4, which forms a proximal portion of catheter lumen 16-3. Mounting aperture 16-4 of seat 16-1 has an enlarged diameter relative to the remainder of catheter lumen 16-3 and, in this embodiment, includes a distally extending inner tapered portion 16-5 (e.g., frustoconical). Flexible, elongated member 16-2 has a distal end portion 16-6.

[0018] The guidewire 18 has a first end 18-1 and a second end 18-2. The guidewire 18 is a typical guidewire known in the art and may be, for example, a flexible metal wire or wire, such as a Nitinol wire or wire.

[0019] exist Figure 1In the embodiment of the present invention, the angiocatheter, which is an ultrasound catheter 20 in this embodiment, has a catheter proximal portion 20-1, a catheter distal portion 20-2, and a guidewire lumen 20-3. The guidewire lumen 20-3 is configured, for example, in size and shape to receive the guidewire 18 so that the angiocatheter, such as the ultrasound catheter 20, can be guided to the area of interest by advancing the angiocatheter in the distal direction 36 over the guidewire 18. In this embodiment, the ultrasound catheter 20 may include a core wire 20-4 that is configured to transmit vibration energy to a working head 20-5 at the catheter distal portion 20-2.

[0020] The vascular device insertion apparatus 12 includes an insertion module housing 24, a motor 26, a motor controller 28, and a slider 30. The motor 26 and the motor controller 28 may be battery operated, and the battery may be housed in the insertion module housing 24.

[0021] The plug-in module housing 24 includes a motor housing 24-1 and a base housing 24-2. The motor housing 24-1 of the plug-in module housing 24 may include a cavity for accommodating and mounting the motor 26. The base housing 24-2 of the plug-in module housing 24 may include a cavity for accommodating and mounting the motor controller 28.

[0022] The motor 26 is slidably mounted to the motor housing 24-1 of the plug module housing 24, for example, by a guide rail, such that the motor 26 can move longitudinally along the longitudinal axis 22 relative to the plug module housing 24. A slider 30 can be mounted to the side wall 24-3 of the plug module housing 24. The slider 30 is connected to the motor 26 by a connecting rod 32 such that longitudinal movement of the slider 30 in a proximal direction 34 or a distal direction 36 causes corresponding longitudinal movement of the motor 26 in the proximal direction 34 or the distal direction 36. In other words, the slider 30 is configured to cause the motor 26 to reciprocate longitudinally along the longitudinal axis 22, i.e., to move alternately in the proximal direction 34 and the distal direction 36, through reciprocating lateral movement of the slider 30 relative to the plug module housing 24.

[0023] The plug-in module housing 24 may also include a plurality of mounting features 38 for connecting to auxiliary devices, such as Figure 2 In this embodiment, the plurality of mounting features 38 can be constructed and arranged as a set of proximally extending posts, and the plurality of mounting features 38 can be magnetic. In this embodiment, the individual mounting features of the plurality of mounting features 38 are identified as mounting feature 38-1, mounting feature 38-2, and mounting feature 38-3.

[0024] The motor 26 can be, for example, a DC motor, such as a stepper motor. The motor 26 has a hollow motor shaft 40 arranged along the longitudinal axis 22. The hollow motor shaft 40 has a proximal end 40-1, a distal end 40-2, a distal end portion 40-3, and an elongated opening 40-4. The elongated opening 40-4 extends along the longitudinal axis 22 from the proximal end 40-1 to the distal end 40-2. In other words, the elongated opening 40-4 extends through the entire length of the hollow motor shaft 40. In this embodiment, for example, the elongated opening 40-4 can have a cylindrical shape that extends through the entire length of the hollow motor shaft 40.

[0025] The distal end portion 40-3 of the hollow motor shaft 40 is configured to couple to the seat 16-1 of the support catheter 16. In the present embodiment, the hollow motor shaft 40 has a distally extending outer tapered portion 40-5 that is sized and shaped to frictionally engage the distally extending inner tapered portion 16-5 of the seat 16-1 of the support catheter 16 to releasably connect the hollow motor shaft 40 of the motor 26 to the seat 16-1 of the support catheter 16.

[0026] When the distal end portion 40-3 of the hollow motor shaft 40 is coupled to the hub 16-1 of the support catheter 16, the elongated opening 40-4 of the hollow motor shaft 40 and the catheter lumen 16-3 of the support catheter 16 collectively define a continuous passage 42 that extends longitudinally through the combination of the support catheter 16 and the hollow motor shaft 40 of the motor 26. A guidewire 18 can be positioned, e.g., advanced, through the continuous passage 42 defined by the elongated opening 40-4 in the hollow motor shaft 40 and the catheter lumen 16-3 of the support catheter 16, with the first end portion 18-3 of the guidewire 18 proximate the proximal end 40-1 of the hollow motor shaft 40. The continuous channel 42 is configured, for example, in size and shape, such that, by manually manipulating the first end portion 18-3 of the guidewire 18, the guidewire 18 can freely move longitudinally in the continuous channel 42, such that the second end 18-2 of the guidewire 18 can extend distally from the distal end portion 16-6 of the support catheter 16. As used herein, the term "freely moveable" means encountering insubstantial resistance to movement, where substantial resistance would cause a longitudinally moving member to buckle or bend.

[0027] As an alternative to or in addition to the guidewire 18, a vascular catheter, such as an ultrasonic catheter 20, can be positioned in a continuous channel 42 defined by an elongated opening 40-4 in the hollow motor shaft 40 and the catheter lumen 16-3 of the support catheter 16, with the catheter proximal portion 20-1 of the ultrasonic catheter 20 proximate the proximal end 40-1 of the hollow motor shaft 40. The continuous channel 42 is configured, for example, in size and shape, such that, by manual manipulation of the catheter proximal portion 20-1 of the ultrasonic catheter 20, the ultrasonic catheter 20 can be freely moved longitudinally in the continuous channel 42, such that the catheter distal portion 20-2 of the ultrasonic catheter 20 can be extended distally from the distal end portion 16-6 of the support catheter 16.

[0028] The motor controller 28 is electrically coupled to the motor 26. For example, the motor controller 28 may be electrically coupled to the motor 26 via electrical wires 44. The motor controller 28 is configured to control the motor 26, for example, via hardwired logic or programmable logic, so as to cause the hollow motor shaft 40 to rotate and oscillate about the longitudinal axis 22, and thereby cause the support conduit 16 to rotate and oscillate, for example, alternating clockwise and counterclockwise. For example, in an embodiment where the motor 26 is a stepper motor, the motor controller 28 would be a stepper motor controller.

[0029] In one embodiment, for example, the rotational oscillation of the hollow motor shaft 40 can be less than one full rotation of the hollow motor shaft 40, and optionally, the rotational oscillation can vary with respect to the range of rotation. For example, the rotational oscillation of the hollow motor shaft 40 can vary between one-eighth of a rotation and one-half of a rotation, alternating between clockwise and counterclockwise rotation directions. Consequently, the support conduit 16 will also rotate and oscillate in accordance with the rotational oscillation of the hollow motor shaft 40.

[0030] The hollow motor shaft 40 of the motor 26 and the support catheter 16 are rotationally oscillated by the motor 26 and / or longitudinally reciprocated by the slider 30, and the guidewire 18 can be manually manipulated and advanced by a user through the continuous channel 42-4 formed by the elongated opening 40 in the hollow motor shaft 40 and the catheter lumen 16-3 of the support catheter 16. For example, in vascular surgery, the rotational oscillation and / or longitudinal reciprocating movement of the distal end portion 16-6 of the flexible elongated member 16-2 of the support catheter 16 is intended to help advance the second end 18-2 of the guidewire 18 so as to pass through and extend beyond a vascular occlusion (partial or complete) in a blood vessel.

[0031] As an alternative to or in addition to the guidewire 18, a vascular catheter, such as an ultrasonic catheter 20, can be manually manipulated and advanced by a user through a continuous channel 42 formed by an elongated opening 40-4 in the hollow motor shaft 40 and the catheter lumen 16-3 of the support catheter 16. For example, during vascular surgery, the rotational oscillation and / or longitudinal reciprocating motion of the distal end portion 16-6 of the flexible elongated member 16-2 of the support catheter 16 can be used to assist a user in manually longitudinally advancing the working tip 20-5 of the catheter distal portion 20-2 of the ultrasonic catheter 20 into engagement with and past a vascular occlusion (partial or complete) in a blood vessel.

[0032] Also refer to Figure 2 , shows a vascular device insertion system 10 configured to include an ultrasound system 50. The ultrasound system 50 includes an ultrasound signal generator 52 and an ultrasound device 54.

[0033] The ultrasonic signal generator 52 is a typical ultrasonic signal generator known in the art and may be configured to generate an ultrasonic electrical signal in the form of an ultrasonic excitation signal, for example in the frequency range of 20 kHz-40 kHz, which is provided to the ultrasonic device 54 via an excitation signal line 56 .

[0034] In this embodiment, the ultrasonic device 54 includes a device housing 58, an ultrasonic transducer 60, and an ultrasonic catheter 20. The core wire 20-4 of the catheter proximal portion 20-1 of the ultrasonic catheter 20 (see FIG. Figure 1 ) is operably coupled to the ultrasonic transducer 60, such as by an acoustic coupling 62. The device housing 58 houses the ultrasonic transducer 60, which is mounted within the interior of the device housing 58. The device housing 58 can be configured as a handpiece to be held by a user, for example, wherein the device housing 58 has a shape and size that facilitates grasping by a user during a medical procedure, such as a procedure related to vascular occlusion.

[0035] The ultrasonic transducer 60 may be, for example, a piezoelectric transducer. The ultrasonic transducer 60 of the ultrasonic device 54 is electrically connected to the ultrasonic signal generator 52 via an excitation signal line 56, and the ultrasonic transducer 60 is configured to receive the ultrasonic excitation signal generated by the ultrasonic signal generator 52 and convert it into ultrasonic vibration energy, which may be within a frequency range corresponding to the frequency range of the ultrasonic excitation signal generated by the ultrasonic signal generator 52. For example, if the frequency of the ultrasonic excitation signal generated by the ultrasonic signal generator 52 and provided to the ultrasonic transducer 60 is 20 kHz, the vibration frequency of the output of the ultrasonic transducer 60 may be correspondingly 20 kHz, which in turn is provided to the core wire 20-4 of the ultrasonic catheter 20 (see FIG. 2 ). Figure 1 ). As mentioned above Figure 1More fully described, the continuous channel 42 of the vascular device insertion apparatus 12 is configured to enable the ultrasonic catheter 20 to move therein so as to extend distally from the support catheter 16 .

[0036] The device housing 58 includes a plurality of mounting features 64. The plurality of mounting features 64 of the device housing 58 are configured to releasably connect to the plurality of mounting features 38 of the insert module housing 24 to releasably mount the device housing 58 to the insert module housing 24. In the present embodiment, the plurality of mounting features 64 can be constructed and arranged as a set of posts or post receptacles (e.g., holes) extending toward the proximal end. In the present embodiment, each of the plurality of mounting features 64 is identified as mounting feature 64-1, mounting feature 64-2, and mounting feature 64-3, which are configured (e.g., in terms of size, shape, and function) to releasably connect to the mounting feature 38-1, mounting feature 38-2, and mounting feature 38-3, respectively, of the insert module housing 24.

[0037] In one embodiment, for example, the plurality of mounting features 38 of the insert module housing 24 and the plurality of mounting features 64 of the device housing 58 can be constructed and arranged to couple together via magnetic attraction. In one embodiment, for example, the opposing paired mounting features of each of the plurality of mounting features 38 of the insert module housing 24 and the plurality of mounting features 64 of the device housing 58 (e.g., mounting feature 38-1 paired with mounting feature 64-1) can be magnets such that magnetic attraction is achieved via a north / south magnetic arrangement to facilitate magnetic coupling of the device housing 58 of the ultrasound device 54 to the insert module housing 24 of the vascular device insertion apparatus 12. In another embodiment, for example, one of the opposing paired mounting features (e.g., mounting feature 38-1 paired with mounting feature 64-1) can be magnetic, while the other can be (or include) a magnetic material, such as iron, to facilitate magnetic coupling of the device housing 58 of the ultrasound device 54 to the insert module housing 24 of the vascular device insertion apparatus 12.

[0038] When the device housing 58 is moved into engagement with the insertion module housing 24, the ultrasound catheter 20 moves longitudinally in the continuous passage 42, for example, through the elongated opening 40-4 of the hollow motor shaft 40 and the catheter lumen 16-3 of the support catheter 16, in the distal direction 36. In embodiments where the continuous passage 42 includes a guidewire 18, the guidewire 18 can be received in the guidewire lumen 20-3 of the ultrasound catheter 20 (see FIG. Figure 1 ) such that when the ultrasonic catheter 20 moves longitudinally in the distal direction 36, the ultrasonic catheter 20 moves distally along the guidewire 18 through the continuous channel 42.

[0039] like Figure 1As depicted in FIG, the operation of the vascular device insertion apparatus 12 will now be described with respect to a vascular procedure in which a guidewire 18 is positioned within a patient's blood vessel. The support catheter 16 is connected to the hollow motor shaft 40 of the motor 26 to establish a continuous passage 42 of the vascular device insertion system 10. The support catheter 16 is inserted into the patient's blood vessel, and the guidewire 18 is subsequently threaded into the elongated opening 40-4 (of the hollow motor shaft 40), which forms the initial portion of the continuous passage 42 of the vascular device insertion system 10. The motor 26 is then actuated by the motor controller 28 such that the hollow motor shaft 40 of the motor 26 and the support catheter 16 (including the distal end portion 16-6 of the flexible elongated member 16-2 of the support catheter 16) rotate and oscillate in unison to assist in advancing the support catheter 16 distally through the blood vessel to the site of the vascular occlusion. Optionally, the motor 26 and the support catheter 16 may also be longitudinally displaced, for example, by a slider 30, alone or in combination with the rotational oscillation, such as by a reciprocating motion. As the hollow motor shaft 40 of the motor 26 and the support catheter 16 rotate and oscillate, the guidewire 18 is manually manipulated and advanced by the physician through the continuous passage 42 formed by the elongated opening 40-4 in the hollow motor shaft 40 and the catheter lumen 16-3 of the support catheter 16, and the second end 18-2 of the guidewire 18 is advanced into engagement with the vascular occlusion in the blood vessel. The rotational oscillation and / or longitudinal reciprocating motion of the distal end portion 16-6 of the flexible elongated member 16-2 of the support catheter 16 assists the physician in further advancing the second end 18-2 of the guidewire 18 to pass through and extend beyond the vascular occlusion (partial or complete) in the blood vessel.

[0040] Reference Figure 1 and 2 , after the guidewire 18 is placed at the desired position in the patient's blood vessel, the first end 18-1 of the guidewire 18 can then be inserted into and passed through the guidewire lumen 20-3 of the ultrasonic catheter 20 of the ultrasonic device 54, so that when the ultrasonic catheter 20 moves longitudinally in the distal direction 36, the ultrasonic catheter 20 can be advanced distally along the guidewire 18 through the continuous channel 42. The ultrasonic signal generator 52 can then be activated to send an ultrasonic excitation signal to the ultrasonic transducer 60. The ultrasonic transducer 60 receives the ultrasonic excitation signal and converts it into ultrasonic vibration energy, which is in turn provided to the core wire 20-4 of the ultrasonic catheter 20 (see Figure 1 ), thereby transmitting vibration energy to the working head 20-5, which engages the proximal end cap of the vascular occlusion and drills into the proximal end cap.

[0041] Although in some of the above examples and embodiments, the structure and operation of the vascular device insertion apparatus 12 have been described with respect to assisting in inserting a guidewire 18 into a desired location in a blood vessel to, for example, guide the positioning of a vascular catheter, such as an ultrasonic catheter 20, it should be understood that in some procedures, if desired, the vascular device insertion apparatus 12 can be used to assist in inserting a vascular catheter directly into a desired location in a blood vessel without the use of a guidewire 18.

[0042] The following items also relate to the present invention:

[0043] In one form, the present invention relates to a vascular device insertion system that can be configured to advance a support catheter in a blood vessel to facilitate the positioning of an auxiliary device, such as a guidewire and / or an ultrasound catheter. The system can include a support catheter having a seat, a flexible, elongated member extending distally from the seat, and a catheter lumen extending through the seat and the flexible, elongated member. The support catheter can be arranged along a longitudinal axis. The system can also include an insertion module housing that can (be configured to) accommodate a motor having a hollow motor shaft arranged along the longitudinal axis. In other words, the system can include a motor. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongated opening that can extend from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft can be configured to be coupled to the seat of the support catheter, for example, in a directly connected manner. The elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous channel. A motor controller can be electrically coupled to the motor. The motor controller can be configured to control the motor to cause the hollow motor shaft to rotate and oscillate about the longitudinal axis and thereby cause the support conduit to rotate and oscillate. Thus, the system is configured so that the motor can (is configured to) cause the hollow motor shaft to rotate and oscillate about the longitudinal axis and thereby cause the support conduit to rotate and oscillate. In other words, the hollow motor shaft and the support conduit can (are configured to) be rotated and oscillated in unison about the (common) longitudinal axis by the motor.

[0044] In some embodiments, the slider can be coupled to the motor.The slider can be configured to reciprocate the motor longitudinally along the longitudinal axis.

[0045] In some embodiments, the system can be configured to facilitate positioning of a guidewire. The guidewire has a first end and a second end. The guidewire can be positioned in a continuous channel defined by an elongated opening in the hollow motor shaft and a catheter lumen of the support catheter, wherein the first end portion of the guidewire can be proximal to the proximal end of the hollow motor shaft. The continuous channel can be configured such that the guidewire can be manually moved in the continuous channel to extend distally from the support catheter.

[0046] In some embodiments, the system may include an ultrasonic catheter having a proximal catheter portion and a distal catheter portion. The ultrasonic catheter may be positioned in a continuous channel defined by an elongated opening in the hollow motor shaft and a catheter lumen of the support catheter, wherein the proximal catheter portion of the ultrasonic catheter may be proximal to a proximal end of the hollow motor shaft. The continuous channel may be configured such that the ultrasonic catheter can be moved in the continuous channel to extend distally from the support catheter.

[0047] In embodiments comprising an ultrasonic catheter, the ultrasonic catheter may include a guidewire lumen configured to receive a guidewire.

[0048] In some embodiments, the system may include an ultrasound device. The ultrasound device may include an ultrasound transducer, a device housing configured to house the ultrasound transducer, and an ultrasound catheter having a proximal catheter portion and a distal catheter portion. The proximal catheter portion is operably coupled to the ultrasound transducer. The continuous channel may be configured such that the ultrasound catheter can move within the continuous channel to extend distally from the support catheter.

[0049] In the embodiment of the previous paragraph, the ultrasound catheter can have a guidewire lumen configured to receive the guidewire.The system can be configured such that when the ultrasound catheter moves in a distal direction over the guidewire, the ultrasound catheter can be guided through the continuous channel along the guidewire.

[0050] In an embodiment including an insert module housing and a device housing, the insert module housing may include a plurality of first mounting features and the device housing may include a plurality of second mounting features. The plurality of first mounting features may be configured to releasably connect to the plurality of second mounting features to mount the device housing to the insert module housing. The system may be configured such that the plurality of first mounting features may be configured to releasably connect to the plurality of second mounting features to mount the device housing to the insert module housing.

[0051] In the embodiment of the preceding paragraph, the plurality of first mounting features of the plug-in module housing and the plurality of second mounting features of the device housing can be configured to form a magnetic connection, for example, can be magnetic.

[0052] In some embodiments that include an ultrasonic transducer as part of a system, the system can include an ultrasonic signal generator electrically coupled to the ultrasonic transducer. The ultrasonic signal generator can be configured to provide an electrical excitation signal to the ultrasonic transducer.

[0053] In another embodiment, the present invention relates to a vascular device insertion system that may include a support catheter having a seat, a flexible, elongated member extending distally from the seat, and a catheter lumen extending through the seat and the flexible, elongated member. The insertion module housing may be configured to house a motor having a hollow motor shaft disposed along a longitudinal axis. The hollow motor shaft has a proximal end, a distal end, a distal end portion, and an elongated opening extending from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft may be configured to couple to the seat of the support catheter. The elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous channel. A guidewire has a first end and a second end, wherein the guidewire may be positioned in the continuous channel defined by the elongated opening in the hollow motor shaft and the catheter lumen of the support catheter. The first end of the guidewire may be proximal to the proximal end of the hollow motor shaft. The continuous channel may be configured such that the guidewire can be freely manually moved within the continuous channel by manually manipulating the first end portion of the guidewire. A motor controller may be electrically coupled to the motor. The motor controller may be configured to rotationally oscillate the hollow motor shaft about the longitudinal axis so as to thereby rotationally oscillate the support conduit.The features of paragraph

[0042] also apply to this form of the invention.

[0054] In some embodiments, the slider can be coupled to the motor, wherein the slider can be configured to reciprocate the motor longitudinally along the longitudinal axis.

[0055] In some embodiments, the system may include an ultrasonic device, which may include an ultrasonic transducer, a device housing configured to accommodate the ultrasonic transducer, and an ultrasonic catheter having a proximal catheter portion, a distal catheter portion, and a guidewire lumen. The proximal catheter portion may be operably coupled to the ultrasonic transducer. The guidewire lumen may be configured to receive the guidewire. The system may be configured so that when the ultrasonic catheter moves longitudinally, the ultrasonic catheter moves longitudinally in a continuous channel along the guidewire.

[0056] In any embodiment having an insert module housing and a device housing, the insert module housing can include a plurality of first mounting features and the device housing can include a plurality of second mounting features. The plurality of first mounting features can be configured to releasably connect to the plurality of second mounting features to mount the device housing to the insert module housing.

[0057] In an embodiment according to the preceding paragraph, the first plurality of mounting features of the plug-in module housing and the second plurality of mounting features of the device housing may be configured to form a magnetic connection, for example, may be magnetic.

[0058] In any embodiments having a device housing, the device housing may be a handpiece configured to be held by a user.

[0059] In any embodiment including an ultrasonic transducer, the system can include an ultrasonic signal generator electrically coupled to the ultrasonic transducer. The ultrasonic signal generator can be configured to provide an electrical excitation signal to the ultrasonic transducer.

[0060] In another form, the present invention relates to a vascular device insertion apparatus that can be configured to advance a support catheter and a guidewire in a blood vessel. The support catheter can have a seat, a flexible, elongated member extending distally from the seat, and a catheter lumen extending through the seat and the flexible, elongated member. The vascular device insertion apparatus can include an insertion module housing configured to accommodate a motor having a hollow motor shaft arranged along a longitudinal axis. The hollow motor shaft can have a proximal end, a distal end, a distal end portion, and an elongated opening extending from the proximal end to the distal end along the longitudinal axis. The distal end portion of the hollow motor shaft can be configured to couple to the seat of the support catheter, wherein the elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous channel. The continuous channel can be configured to receive a guidewire. A motor controller can be electrically coupled to the motor. The motor controller can be configured to cause the hollow motor shaft to rotate and oscillate about the longitudinal axis so as to thereby cause the support catheter to rotate and oscillate. This form of the invention is directed to the vascular device insertion system of paragraph

[0042] , wherein the continuous channel can be configured to receive a guidewire. The features of paragraphs

[0042] to

[0051] also apply to this form of the invention.

[0061] In some embodiments, the slider can be coupled to the motor.The slider can be configured to cause the motor to reciprocate longitudinally along the longitudinal axis.

[0062] In any embodiment, the plug-in module housing may optionally include a plurality of mounting features configured to mount to the device housing of the ultrasound transducer.

[0063] As used herein, degree words are relative modifiers that are intended to indicate the permissible variation from the property so modified. Such terms are not intended to be limited to the absolute value of the property they modify, but rather to have more physical or functional properties than the opposite property.

[0064] Although the present invention has been described with respect to at least one embodiment, the present invention may be further modified within the spirit and scope of the present disclosure. Therefore, this application is intended to cover any variation, use or modification of the present invention using its general principles. In addition, this application is intended to cover deviations from the present disclosure that fall within known or customary practices in the field to which the present invention pertains and that fall within the limitations of the appended claims.

Claims

1. A vascular device insertion system comprising: a support catheter having a seat, a flexible elongated member extending distally from the seat, and a catheter lumen extending through the seat and the flexible elongated member; an insert module housing configured to house a motor having a hollow motor shaft disposed along a longitudinal axis, the hollow motor shaft having a proximal end, a distal end, a distal end portion, and an elongated opening extending along the longitudinal axis from the proximal end to the distal end, the distal end portion of the hollow motor shaft configured to couple to the seat of the support catheter, and wherein the elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous passageway; and A motor controller is electrically coupled to the motor, the motor controller being configured to control the motor to rotationally oscillate the hollow motor shaft about the longitudinal axis and thereby rotationally oscillate the support conduit.

2. The vascular device insertion system of claim 1, comprising a slider coupled to the motor, the slider configured to cause the motor to reciprocate longitudinally along the longitudinal axis.

3. A vascular device insertion system according to claim 1 or 2, comprising a guide wire having a first end and a second end, wherein the guide wire is positioned in the continuous channel defined by the elongated opening in the hollow motor shaft and the catheter lumen of the support catheter, wherein the first end portion of the guide wire is close to the proximal end of the hollow motor shaft, and the continuous channel is configured so that the guide wire can be manually moved in the continuous channel to extend distally from the support catheter.

4. A vascular device insertion system according to claim 3, comprising an ultrasonic catheter having a proximal catheter portion and a distal catheter portion, wherein the ultrasonic catheter is positioned in the continuous channel defined by the elongated opening in the hollow motor shaft and the catheter lumen of the support catheter, wherein the proximal catheter portion of the ultrasonic catheter is close to the proximal end of the hollow motor shaft, and the continuous channel is configured to enable the ultrasonic catheter to move in the continuous channel to extend distally from the support catheter. 5 . The vascular device insertion system of claim 4 , wherein the ultrasonic catheter comprises a guidewire lumen configured to receive the guidewire.

6. The vascular device insertion system according to claim 1 or 2, further comprising an ultrasound device, the ultrasound device comprising: Ultrasonic transducer; a device housing configured to house the ultrasonic transducer; and an ultrasound catheter having a catheter proximal portion and a catheter distal portion, the catheter proximal portion operably coupled to the ultrasound transducer, The continuous channel is configured such that the ultrasonic catheter can move in the continuous channel to extend distally from the supporting catheter.

7. A vascular device insertion system according to claim 6, wherein the ultrasonic catheter has a guidewire lumen configured to receive a guidewire, and the vascular device insertion system is configured so that when the ultrasonic catheter moves in a distal direction over the guidewire, the ultrasonic catheter is guided along the guidewire through the continuous channel.

8. The vascular device insertion system of claim 6, wherein: The insert module housing includes a first plurality of mounting features; and the device housing including a plurality of second mounting features, Wherein the plurality of first mounting features are configured to releasably connect to the plurality of second mounting features to mount the device housing to the plug-in module housing.

9. The vascular device insertion system of claim 8, wherein the plurality of first mounting features of the insertion module housing and the plurality of second mounting features of the device housing are magnetic.

10. The vascular device insertion system of claim 6, further comprising an ultrasonic signal generator electrically coupled to the ultrasonic transducer, the ultrasonic signal generator configured to provide an electrical excitation signal to the ultrasonic transducer.

11. A vascular device insertion system comprising: a support catheter having a seat, a flexible elongated member extending distally from the seat, and a catheter lumen extending through the seat and the flexible elongated member; an insert module housing configured to house a motor having a hollow motor shaft disposed along a longitudinal axis, the hollow motor shaft having a proximal end, a distal end, a distal end portion, and an elongated opening extending along the longitudinal axis from the proximal end to the distal end, the distal end portion of the hollow motor shaft configured to couple to the seat of the support catheter, and wherein the elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous passageway; a guidewire having a first end and a second end, the guidewire positioned in the continuous channel defined by the elongated opening in the hollow motor shaft and the catheter lumen of the support catheter, wherein the first end portion of the guidewire is proximate the proximal end of the hollow motor shaft, and the continuous channel is configured such that the guidewire can be freely manually moved therein by manual manipulation of the first end portion of the guidewire; and A motor controller is electrically coupled to the motor, the motor controller being configured to rotationally oscillate the hollow motor shaft about the longitudinal axis to thereby rotationally oscillate the support conduit.

12. The vascular device insertion system of claim 11, comprising a slider coupled to the motor, the slider configured to reciprocate the motor longitudinally along the longitudinal axis.

13. The vascular device insertion system according to claim 11 or 12, further comprising an ultrasound device, the ultrasound device comprising: Ultrasonic transducer; a device housing configured to house the ultrasonic transducer; and an ultrasound catheter having a catheter proximal portion operably coupled to the ultrasound transducer, a catheter distal portion, and a guidewire lumen configured to receive the guidewire; The vascular device insertion system is configured such that when the ultrasonic catheter is moved longitudinally, the ultrasonic catheter moves longitudinally in the continuous channel along the guidewire.

14. The vascular device insertion system of claim 13, wherein: The insert module housing includes a first plurality of mounting features; and the device housing including a plurality of second mounting features, Wherein the plurality of first mounting features are configured to releasably connect to the plurality of second mounting features to mount the device housing to the plug-in module housing.

15. The vascular device insertion system of claim 14, wherein the plurality of first mounting features of the insertion module housing and the plurality of second mounting features of the device housing are magnetic.

16. The vascular device insertion system of claim 13, wherein the device housing is a handpiece configured to be held by a user.

17. The vascular device insertion system of claim 13, further comprising an ultrasonic signal generator electrically coupled to the ultrasonic transducer, the ultrasonic signal generator configured to provide an electrical excitation signal to the ultrasonic transducer.

18. A vascular device insertion apparatus for advancing a support catheter and a guidewire in a blood vessel, the support catheter having a seat, a flexible, elongated member extending distally from the seat, and a catheter lumen extending through the seat and the flexible, elongated member, the vascular device insertion apparatus comprising: an insertion module housing configured to house a motor having a hollow motor shaft disposed along a longitudinal axis, the hollow motor shaft having a proximal end, a distal end, a distal end portion, and an elongated opening extending along the longitudinal axis from the proximal end to the distal end, the distal end portion of the hollow motor shaft configured to couple to the seat of the support catheter, wherein the elongated opening of the hollow motor shaft and the catheter lumen of the support catheter together define a continuous passage, and the continuous passage is configured to receive the guidewire; and A motor controller is electrically coupled to the motor, the motor controller being configured to rotationally oscillate the hollow motor shaft about the longitudinal axis to thereby rotationally oscillate the support conduit.

19. The vascular device insertion apparatus of claim 18, comprising a slider coupled to the motor, the slider configured to reciprocate the motor longitudinally along the longitudinal axis.

20. The vascular device insertion apparatus of claim 18 or 19, wherein the insertion module housing includes a plurality of mounting features configured to mount to a device housing of an ultrasound transducer.

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