WO2018053633A1 - Catheter advancement device - Google Patents

Catheter advancement device Download PDF

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Publication number
WO2018053633A1
WO2018053633A1 PCT/CA2017/051110 CA2017051110W WO2018053633A1 WO 2018053633 A1 WO2018053633 A1 WO 2018053633A1 CA 2017051110 W CA2017051110 W CA 2017051110W WO 2018053633 A1 WO2018053633 A1 WO 2018053633A1
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WO
WIPO (PCT)
Prior art keywords
medical instrument
drive mechanism
wheel
instrument
receiving
Prior art date
Application number
PCT/CA2017/051110
Other languages
French (fr)
Inventor
Ben SAFA
Original Assignee
Sunnybrook Health Sciences Centre
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sunnybrook Health Sciences Centre filed Critical Sunnybrook Health Sciences Centre
Publication of WO2018053633A1 publication Critical patent/WO2018053633A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M25/09041Mechanisms for insertion of guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113Mechanical advancing means, e.g. catheter dispensers

Definitions

  • the present disclosure is related to devices for advancement of a catheter or guidewire, or other medical instrument.
  • the present disclosure may be applicable for one-handed advancement of a wire, catheter or other medical instrument, and may be suitable for any procedures involving placement of such instruments, such as in regional anesthesia and continuous peripheral nerve catheter insertion .
  • Ultrasound imaging for needle placement in various medical procedures is commonly used, particularly for peripheral nerve blocks wherein a drug is delivered to a target site within a patient via a catheter.
  • an ultrasound probe may be used to identify the target region and to provide an image of needle advancement to the target region .
  • the drug may be delivered through the needle.
  • the physician advances an infusion catheter through the needle so that the tip of the catheter is also placed in the target region .
  • the needle may then be removed and drug delivery commenced through the catheter.
  • the physician In a conventional procedure using ultrasound imaging guidance, the physician generally uses one hand to hold and manipulate the ultrasound probe against the patient, while using the other hand to guide the needle to the identified target region . Once the needle tip has been placed and verified within the target region, the physician holds the needle as steady as possible. A separate assistant then threads a catheter through the needle, while the physician holds the needle steady and controls the ultrasound probe. Alternatively, the physician forgoes live imaging and releases the ultrasound probe in order to stabilize the needle and advance the catheter. This procedure may be tedious, cumbersome, and typically requires multiple persons or else requires abandoning the live ultrasound imaging.
  • the present disclosure provides a device for advancement of a medical instrument.
  • the device may include a body and a drive mechanism.
  • the body may include an attachment portion for attaching the device to a receiving instrument.
  • the drive mechanism may be provided on the body for advancing the medical instrument in the receiving instrument.
  • the mechanism may include at least one wheel for frictionally engaging the medical instrument, the at least one wheel being moveable to enable disengagement of the drive mechanism from the medical instrument.
  • the present disclosure provides a kit that may include the device described above, the medical instrument, and the receiving instrument.
  • the present disclosure provides a method of advancing a medical instrument.
  • the method may include : positioning a receiving instrument in a patient; attaching the device described above to a proximal end of the receiving instrument; engaging the drive mechanism of the device with the medical instrument; advancing the medical instrument in the receiving instrument to a desired position, using the drive mechanism; disengaging the drive mechanism from the medical instrument while the medical instrument is at the desired position; and detaching the device from the receiving instrument.
  • the receiving instrument may be a Tuohy needle, the medical instrument may be a catheter or a guidewire.
  • Examples described in the present disclosure may be suitable for use in various procedures involving the placement of wires, catheters or other similar medical instruments.
  • procedures in which single-handed advancement of a wire, catheter or similar medical instrument would be beneficial e.g., where the other hand is used to hold an imaging probe or is otherwise occupied
  • FIG . 1 is a top view of an example of a catheter advancement device, engaged with a needle and a catheter;
  • FIG . 2 is a perspective view of the example device of FIG. 1, separated from the needle and catheter;
  • FIG . 3 is another perspective view of the example device of FIG. 1;
  • FIG . 4 is a perspective view of a body for the example device of FIG. 1 ;
  • FIG . 5 is a perspective view of a wheel of a drive mechanism for the example device of FIG. 1;
  • FIG . 6 is a side view of another example of a catheter advancement device, engaged with a catheter
  • FIG . 7 is a top view of the example device of FIG. 6, engaged with a catheter;
  • FIG . 8 is a top view of another example of a catheter advancement device, with a wheel disassembled;
  • FIG . 9 is a top view of the example device of FIG. 8, engaged with a catheter;
  • FIG . 10 is a top view of another example of a catheter advancement device
  • FIG . 11 is a perspective view of another example of a catheter advancement device
  • FIG . 12 is a top view of the example device of FIG . 11, moved into a disengaged configuration
  • FIG . 13 is a top view of the example device of FIG . 11, in an engaged configuration
  • FIG . 14 is a perspective view of another example of a catheter advancement device
  • FIG . 15 is a top view of the example device of FIG . 14;
  • FIG . 16 is a front view of the example device of FIG. 14.
  • FIG . 17 is a side view of the example device of FIG. 14.
  • the present disclosure provides a catheter or guidewire advancement device.
  • the present disclosure may refer to the device in some instances as a catheter advancement device, however it should be understood that examples of the device may be used to advance any suitable medical instrument including, for example, catheters and guidewires. References to a catheter or guidewire in the present disclosure should be understood to be generally applicable to any suitable medical instrument.
  • the device may be brought into engagement with the needle and the catheter or guidewire at any point during the medical procedure. Further, the device may be removable from the needle and catheter or guidewire at any point in the procedure, with little or no disturbance to the catheter or guidewire.
  • the device includes a drive mechanism for advancing the catheter or guidewire. The drive mechanism may also be used to retract the catheter or guidewire.
  • FIGS. 1-5 illustrate an example of the device in which the drive mechanism includes two wheels. The catheter or guidewire may be engaged between the two wheels.
  • At least one wheel may be removably attached to the device by an attaching mechanism configured so that the at least one wheel may be readily removed from the device, thus releasing the device from the catheter or guidewire without disturbing the catheter or guidewire. In some examples, at least one wheel may be readily moved away from the catheter or guidewire to disengage the catheter or guidewire.
  • FIG . 1 illustrates an example of the device attached to a Tuohy needle and engaged with a catheter.
  • FIG. 1 shows the device attached to a Tuohy needle
  • the device may be readily adapted to be used with other needles or other instruments providing access (e.g., an access port or hollow tube).
  • the size of the device may be readily adapted to accommodate different needle sizes and/or needles having different proximal ends.
  • the example device 3 may attach to a receiving instrument 1 , such as a Tuohy needle, with an attachment portion 4.
  • the device 3 may engage a medical instrument 2, such as a catheter or a guidewire, with a drive mechanism 5.
  • FIGS. 2 and 3 show the example device 3 detached from the catheter and the Tuohy needle.
  • the example device 3 includes a body 8, which is shown separated from the drive mechanism 5 in FIG . 4.
  • the distal end of the body 8 may be attached to the proximal hub of the receiving instrument 1.
  • the body 8 includes an attachment portion 4 for attaching the device 3 to the receiving instrument 1.
  • the attachment portion 4 includes two walls 9 on two opposing edges of the attachment portion 4, having a gap between the two walls 9.
  • the walls 9 extend substantially vertically from the body 8, and the receiving instrument 1 may be clipped on or otherwise positioned between the walls 9.
  • the body 8 and/or the attachment portion 4 may be adapted for use with different receiving instruments 1 (e.g. , differently sized needles), for example the body 8 and/or the attachment portion 4 may be manufactured to different sizes.
  • At least the walls 9 may be made of a flexible material, such as a plastic.
  • the attachment portion 4 may be pushed onto the receiving instrument 1 because of the inherent flexibility of the walls 9. Once pushed into place, the two walls 9 may latch onto the receiving instrument 1 by the tendency of the walls 9 to return to their undeformed configuration. When it is desired to remove the device 3 from the receiving instrument 1, the device 3 may simply be pushed off.
  • the attachment portion 4 may have other configurations.
  • the walls 9 may be substantially parallel to each other, or the walls 9 may be in other arrangements (e.g., curved or slanted towards each other) to enable adequate attachment to the receiving instrument 1.
  • the attachment portion 4 is shown in FIGS. 1-5 as having walls 9, the attachment portion 4 may include other configurations in addition to or in place of the walls 9 to enable the device 3 to be removably attached to the receiving instrument 1.
  • FIGS. 1-5 show the walls 9 as formed in one piece with the body 8.
  • the attachment portion 4 and/or the walls 9 may be provided on the body 8 by other means (e.g., assembled from separate components).
  • the device 3 also includes a drive mechanism 5.
  • the drive mechanism 5 includes two wheels 6.
  • the drive mechanism 5 may include greater or fewer number of wheels 6, as discussed further below.
  • the device mechanism 5 is configured to advance the medical instrument 2 (e.g ., catheter or guidewire). In operation, the medical instrument 2 is frictionally engaged between the two wheels 6. In some examples the medical instrument 2 may be threaded in between the wheels 6 by an operator.
  • the medical instrument 2 may be disposed between the wheels by any suitable method.
  • the operator may turn at least one of the wheels 6.
  • At least one of the wheels 6 may be configured with teeth, ridges or other patterns on a surface intended for contact with the medical instrument 2, to increase friction .
  • the other wheel 6 may have the same, complementary or similar patterns on a surface intended for contact with the medical instrument 2.
  • each wheel 6 may have features complementary to each other (e.g., complementary teeth, protrusions and/or recesses), to enable rotation of one wheel 6 to drive rotation of the other wheel 6.
  • the wheels 6 may simply frictionally engage each other.
  • at least one of the wheels 6 may have an annular groove 11 around the outer surface intended contact with the medical instrument 2, as shown in FIG. 5.
  • the groove 11 may be configured to partially receive the medical instrument 2 and to limit the movement of the medical instrument 2 when received.
  • the two wheels 6 do not contact each other, having a gap between the wheels 6 for receiving the medical instrument 2.
  • the gap may be narrower than the diameter of the medical instrument 2, to enable a frictional engagement.
  • the wheels 6 may be configured to ensure the medical instrument 2 is frictionally engaged therebetween, while avoiding excessive compression or damage to the medical instrument 2.
  • At least one wheel 6 may be moveable to enable disengagement of the drive mechanism 5 from the medical instrument 2.
  • at least one wheel 6 may be readily removed from the drive mechanism 5.
  • each wheel 6 is attached to the drive mechanism 5 by an axle 7.
  • at least one axle 7 comprises two prongs 10 extending along the axis of rotation with a gap between the prongs 10. More prongs 10 may be used, for example, three, four or more prongs 10. The wheel 6 may be removed from the axle 7 by squeezing the prongs 10 together, or may be removed from the axle 7 by exertion of sufficient force.
  • the prongs 10 may have enlarged portions 12.
  • the enlarged portions 12 may be located close to the ends of the prongs 8 away from the body 8, such that when the wheel 6 is fitted over the axle 7, the enlarged portions 12 limit the range of movement allowed for the wheel 6 and help to maintain the wheel 6 in place.
  • FIGS. 6 and 7 illustrate an example of the device 3 in which the drive mechanism 5 includes a single wheel 6.
  • the wheel 6 may frictionally engage the medical instrument 2 against another surface or part of the device 3, such as a surface on the body 8.
  • a projection (not shown) on the body 8 that urges the medical instrument 2 against a surface of the wheel 6.
  • the wheel 6 may be disposed so that the wheel 6 engages the medical instrument 2 against an upper surface of the body 8.
  • the wheel 6 and/or the surface of the body 8 against which the medical instrument 2 is intended to be engaged may have a groove for receiving the medical instrument 2.
  • the wheel 6 may be removable from the drive mechanism 5 together with the axle 7.
  • the drive mechanism 5 may include three wheels 6.
  • two of the wheels 6 may be disposed to frictionally engage the medical instrument 2 therebetween, similar to that described above with reference to FIGS. 1-5.
  • the third wheel 6 may engage one of the other two wheels 6 (e.g ., frictionally or via complementary features on the wheels 6) .
  • the third wheel 6 may be turned to cause the other two wheels 6 to turn. It may be useful to provide the third wheel 6 so that the operator's action of rotating the third wheel 6 is more intuitively in agreement with the direction of the movement of the medical instrument 2.
  • the drive mechanism 5 may be disengaged from the medical instrument 2 by removing at least one wheel 6 from the drive mechanism 5.
  • the wheel 6 may be removed from an axle 7 (e.g., as described with reference to FIGS. 1-5) or the wheel 6 may be removed together with the axle 7 (e.g., as described with reference to FIGS. 6-7) .
  • FIGS. 8 and 9 illustrate an example of the device 3 in which at least one wheel 6 may be moveable by sliding along a track 13 defined in the body 8.
  • the wheel 6 may be slide into and out of engagement with the medical instrument 2, without having to remove the wheel 6 from the drive mechanism 5 (see FIG . 9) .
  • the wheel 6 may also be removed from the drive mechanism 5 by sliding the wheel 6 out of the track 13 (see FIG. 8).
  • at least one wheel 6 may be tiltable relative to the body 8 to enable the drive mechanism 5 to engage and disengage the medical instrument 2.
  • at least one axle 7 that receives the wheel 6 may be moveable outwardly away from the medical instrument 2, thus allowing the medical instrument 2 to be released without disturbing the position of the medical instrument 2. When thus tilted, the wheels 6 no longer share a common plane.
  • the device 3 may be integrated with the receiving instrument 1, while retaining the ability to engage and disengage the medical instrument 2 readily as described above.
  • the device 3 may be configured to enable the device 3 to be inserted into the Tuohy needle, similar to a slip tip.
  • An example of such a configuration is illustrated in FIG . 10.
  • the attachment portion 4 is configured to snugly fit into the proximal end of the receiving
  • FIGS. 11- 13 illustrate an example of the device 3 in which the body 8 may be moved between engaged and disengaged configurations to engage and disengage, respectively, the drive mechanism 5 from the medical instrument 2.
  • the body 8 may be provided in two parts 8a, 8b, which may be individually attached to the receiving instrument 1.
  • each part 8a, 8b may have a respective attachment portion 4a, 4b to clip onto the proximal end of the receiving instrument 1.
  • the attachment portion 4a, 4b may include a hinge that may be removably or permanently attached to the receiving instrument 1.
  • the drive mechanism 5 includes two wheels 6, each wheel 6 being separately provided on a respective separate part 8a, 8b of the body 8.
  • the body 8 is in the disengaged configuration, in which the wheels 6 are moved apart from each other.
  • the drive mechanism 5 can be disengaged from the medical instrument (not shown) .
  • the separate parts 8a, 8b of the body 8 can be brought together into the engaged configuration (see FIG. 13), for example by pivoting the parts 8a, 8b on the hinge of the attachment portion 4a, 4b.
  • the wheels 6 of the drive mechanism 5 can frictionally engage the medical instrument (not shown) to enable advancement/retraction of the medical instrument, as described above.
  • the parts 8a, 8b of the body 8 may be provided with a fastening mechanism (e.g., complementary parts of an interlocking system, such as a snap-fit) to ensure the body 8 stays in the engaged configuration.
  • a fastening mechanism e.g., complementary parts of an interlocking system, such as a snap-fit
  • FIGS. 11-13 illustrate the drive mechanism 5 having two wheels 6, it should be understood that the drive mechanism 5 may have fewer or greater number of wheels 6, as discussed above.
  • FIGS. 14- 17 illustrate another example of the device 3.
  • the body 8 includes a pivotable portion 8c that pivots relative to the main body 8, to enable the body 8 to move between engaged and disengaged
  • FIGS. 14- 17 show the example device 3 in the disengaged configuration .
  • One wheel 6 of the drive mechanism 5 is mounted on the pivotable portion 8c and the other wheel 6 is mounted on the main body 8.
  • Each wheel 6 may have protrusions, teeth or other complementary feature that engage with each other, when in the engaged configuration, to help ensure that the wheels 6 are aligned and/or that rotation of one wheel 6 causes rotation of the other wheel 6.
  • the annular groove 11 of each wheel 6 has a concave profile, so that, when in the engaged configuration, the grooves 11 together define a passage for the medical instrument 2 to be threaded therethrough.
  • the grooves 11 may be configured such that they define a passage that is slightly narrower than the diameter of the medical instrument 2, to ensure that the medical instrument 2 is frictionally engaged, without excessively compressing the medical instrument 2.
  • the wheels 6 may be designed to not be removable from the body 8. Instead of axles 7 mounting the wheels 6, each wheel 6 may be provided with a post 14. Each post 14 may rotate with the respective wheel 6, or may be stationary when the respective wheel 6 rotates.
  • the posts 14 may be configured with a rounded surface, as in the example shown, to improve comfort and ergonomics when the device 3 is held by an operator. In some examples, the posts 14 may be omitted.
  • the pivotable portion 8c may be provided with a clip 15 or other fastening mechanism to enable the pivotable portion 8c to be fastened to the main body 8 when in the engaged configuration . This may help to ensure that the pivotable portion 8c does not accidentally disengage from the engaged
  • the clip 15 may fit over the side of the main body 8. In other examples, the clip 15 may fit into a recess defined on the underside of the main body 8. Other fastening mechanisms may be used, or the fastening mechanism may be omitted.
  • Engagement of the pivotable portion 8c with the main body 8 may also be assisted by a protrusion 16 of the pivotable portion 8c that fits into a recess 17 defined in the main body 8 when in the engaged configuration.
  • the protrusion 16 and recess 17 may engage each other in a friction fit, for example, and may help to ensure that the pivotable portion 8c does not accidentally disengage from the engaged configuration.
  • the protrusion 16 and recess 17 may also help to ensure the wheels 6 are aligned with each other when in the engaged configuration.
  • the protrusion 16 may be provided on the main body 8 and the recess 17 may be defined in the pivotable portion 8c instead.
  • protrusion 16 and recess 17 may thus provide another fastening mechanism for maintaining the body 8 in the engaged configuration .
  • only the protrusion 16 and recess 17 may be provided and the clip 15 omitted; in other examples, only the clip 15 may be provided and the protrusion 16 and recess 17 omitted; in other examples, the clip 15 as well as the protrusion 16 and recess 17 may be omitted; in other examples, one or more other fastening mechanisms may be used .
  • the device 3 may be provided with the pivotable portion 8c already pivotably attached to the main body 8. In other examples, the device 3 may be provided with the pivotable portion 8c separate from the main body 8 and these pieces may be attached together by the operator.
  • the device 3 may be configured (e.g. , with an open top) to enable visualization of the medical instrument 2 when it is engaged in the device 3.
  • Examples of the device 3 may be provided as a kit together with the receiving instrument 1 (e.g., Tuohy needle) and medical instrument 2 (e.g. , nerve catheter or guidewire).
  • the kit may be provided for a regional anaesthesia procedure, ultrasound guided vascular access, placement of a guidewire or catheter, or other similar procedure.
  • the device 3, along with the entire kit, may be sterilizable and/or disposable.
  • the catheter advancement device may be attached to a receiving instrument (e.g., Tuohy needle) after the receiving instrument has been positioned in the patient (e.g. , with assistance from ultrasound guidance).
  • the medical instrument e.g., catheter or guidewire
  • the operator may advance the medical instrument by manipulating the drive mechanism, for example using one hand while holding an ultrasound probe with the other hand. In this way, ultrasound guidance can be maintained when advancing the medical instrument.
  • the drive mechanism may be disengaged from the medical instrument and the device may be detached, all while the inserted medical instrument is undisturbed.
  • the catheter advancement device may be incorporated into the receiving instrument (e.g., formed together with the proximal end of the receiving instrument), and may not be removable from the receiving instrument.
  • the device still enables the medical instrument to be advanced or retracted by manipulating the drive mechanism using one hand, and enables the medical instrument to be engaged or disengaged from the drive mechanism at any time without disturbing the position of the medical instrument.
  • the device does not require an attachment portion and would not need to be attached to the receiving instrument during the medical procedure.
  • the disclosed catheter advancement device may be used for placement of any wire, catheter or similar medical instrument, and may be used for any procedure involving placement of such instruments.
  • the present disclosure may be applicable for placement of a wire for access to blood vessels and/or hollow organs, such as in the Seldinger technique under ultrasound guidance.
  • the embodiments of the present disclosure described above are intended to be examples only. The present disclosure may be embodied in other specific forms. Alterations, modifications and variations to the disclosure may be made without departing from the intended scope of the present disclosure.

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Abstract

A device for advancement of a medical instrument is provided. The device includes a drive mechanism that engages and drives the medical instrument, to advance the medical instrument into a receiving instrument. The drive mechanism readily engages and disengages the medical instrument.

Description

CATHETER ADVANCEMENT DEVICE
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This disclosure claims priority from U.S. provisional patent application no. 62/398,234, entitled "CATHETER ADVANCEMENT DEVICE", filed September 22, 2016, the entirety of which is hereby incorporated by reference.
FIELD
[0002] The present disclosure is related to devices for advancement of a catheter or guidewire, or other medical instrument. In particular, the present disclosure may be applicable for one-handed advancement of a wire, catheter or other medical instrument, and may be suitable for any procedures involving placement of such instruments, such as in regional anesthesia and continuous peripheral nerve catheter insertion .
BACKGROUND
[0003] Ultrasound imaging for needle placement in various medical procedures is commonly used, particularly for peripheral nerve blocks wherein a drug is delivered to a target site within a patient via a catheter. With such procedures, an ultrasound probe may be used to identify the target region and to provide an image of needle advancement to the target region . Once location of the needle tip within the target region is verified, the drug may be delivered through the needle. In certain procedures, such as where long-term or continuous drug delivery is needed, the physician advances an infusion catheter through the needle so that the tip of the catheter is also placed in the target region . The needle may then be removed and drug delivery commenced through the catheter.
[0004] In a conventional procedure using ultrasound imaging guidance, the physician generally uses one hand to hold and manipulate the ultrasound probe against the patient, while using the other hand to guide the needle to the identified target region . Once the needle tip has been placed and verified within the target region, the physician holds the needle as steady as possible. A separate assistant then threads a catheter through the needle, while the physician holds the needle steady and controls the ultrasound probe. Alternatively, the physician forgoes live imaging and releases the ultrasound probe in order to stabilize the needle and advance the catheter. This procedure may be tedious, cumbersome, and typically requires multiple persons or else requires abandoning the live ultrasound imaging.
SUMMARY
[0005] In some examples, the present disclosure provides a device for advancement of a medical instrument. The device may include a body and a drive mechanism. The body may include an attachment portion for attaching the device to a receiving instrument. The drive mechanism may be provided on the body for advancing the medical instrument in the receiving instrument. The drive
mechanism may include at least one wheel for frictionally engaging the medical instrument, the at least one wheel being moveable to enable disengagement of the drive mechanism from the medical instrument.
[0006] In some examples, the present disclosure provides a kit that may include the device described above, the medical instrument, and the receiving instrument.
[0007] In some examples, the present disclosure provides a method of advancing a medical instrument. The method may include : positioning a receiving instrument in a patient; attaching the device described above to a proximal end of the receiving instrument; engaging the drive mechanism of the device with the medical instrument; advancing the medical instrument in the receiving instrument to a desired position, using the drive mechanism; disengaging the drive mechanism from the medical instrument while the medical instrument is at the desired position; and detaching the device from the receiving instrument. [0008] The receiving instrument may be a Tuohy needle, the medical instrument may be a catheter or a guidewire.
[0009] Examples described in the present disclosure may be suitable for use in various procedures involving the placement of wires, catheters or other similar medical instruments. In particular, procedures in which single-handed advancement of a wire, catheter or similar medical instrument would be beneficial (e.g., where the other hand is used to hold an imaging probe or is otherwise occupied) may benefit from the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS [0010] Reference will now be made, by way of example, to the accompanying drawings which show example embodiments of the present application, and in which :
[0011] FIG . 1 is a top view of an example of a catheter advancement device, engaged with a needle and a catheter;
[0012] FIG . 2 is a perspective view of the example device of FIG. 1, separated from the needle and catheter;
[0013] FIG . 3 is another perspective view of the example device of FIG. 1;
[0014] FIG . 4 is a perspective view of a body for the example device of FIG. 1 ;
[0015] FIG . 5 is a perspective view of a wheel of a drive mechanism for the example device of FIG. 1;
[0016] FIG . 6 is a side view of another example of a catheter advancement device, engaged with a catheter;
[0017] FIG . 7 is a top view of the example device of FIG. 6, engaged with a catheter; [0018] FIG . 8 is a top view of another example of a catheter advancement device, with a wheel disassembled;
[0019] FIG . 9 is a top view of the example device of FIG. 8, engaged with a catheter;
[0020] FIG . 10 is a top view of another example of a catheter advancement device;
[0021] FIG . 11 is a perspective view of another example of a catheter advancement device;
[0022] FIG . 12 is a top view of the example device of FIG . 11, moved into a disengaged configuration;
[0023] FIG . 13 is a top view of the example device of FIG . 11, in an engaged configuration;
[0024] FIG . 14 is a perspective view of another example of a catheter advancement device;
[0025] FIG . 15 is a top view of the example device of FIG . 14;
[0026] FIG . 16 is a front view of the example device of FIG. 14; and
[0027] FIG . 17 is a side view of the example device of FIG. 14.
[0028] Similar reference numerals may have been used in different figures to denote similar components.
DESCRIPTION OF EXAMPLE EMBODIMENTS
[0029] In various examples described herein, the present disclosure provides a catheter or guidewire advancement device. The present disclosure may refer to the device in some instances as a catheter advancement device, however it should be understood that examples of the device may be used to advance any suitable medical instrument including, for example, catheters and guidewires. References to a catheter or guidewire in the present disclosure should be understood to be generally applicable to any suitable medical instrument.
[0030] The device may be brought into engagement with the needle and the catheter or guidewire at any point during the medical procedure. Further, the device may be removable from the needle and catheter or guidewire at any point in the procedure, with little or no disturbance to the catheter or guidewire. In examples described herein, the device includes a drive mechanism for advancing the catheter or guidewire. The drive mechanism may also be used to retract the catheter or guidewire. [0031] FIGS. 1-5 illustrate an example of the device in which the drive mechanism includes two wheels. The catheter or guidewire may be engaged between the two wheels.
[0032] In some examples, at least one wheel may be removably attached to the device by an attaching mechanism configured so that the at least one wheel may be readily removed from the device, thus releasing the device from the catheter or guidewire without disturbing the catheter or guidewire. In some examples, at least one wheel may be readily moved away from the catheter or guidewire to disengage the catheter or guidewire.
[0033] FIG . 1 illustrates an example of the device attached to a Tuohy needle and engaged with a catheter. Although FIG. 1 shows the device attached to a Tuohy needle, the device may be readily adapted to be used with other needles or other instruments providing access (e.g., an access port or hollow tube). For example, the size of the device may be readily adapted to accommodate different needle sizes and/or needles having different proximal ends. [0034] The example device 3 may attach to a receiving instrument 1 , such as a Tuohy needle, with an attachment portion 4. The device 3 may engage a medical instrument 2, such as a catheter or a guidewire, with a drive mechanism 5. FIGS. 2 and 3 show the example device 3 detached from the catheter and the Tuohy needle.
[0035] The example device 3 includes a body 8, which is shown separated from the drive mechanism 5 in FIG . 4. In this example, the distal end of the body 8 may be attached to the proximal hub of the receiving instrument 1.
[0036] The body 8 includes an attachment portion 4 for attaching the device 3 to the receiving instrument 1. In the example of FIGS. 1-5, the attachment portion 4 includes two walls 9 on two opposing edges of the attachment portion 4, having a gap between the two walls 9. The walls 9 extend substantially vertically from the body 8, and the receiving instrument 1 may be clipped on or otherwise positioned between the walls 9. The body 8 and/or the attachment portion 4 may be adapted for use with different receiving instruments 1 (e.g. , differently sized needles), for example the body 8 and/or the attachment portion 4 may be manufactured to different sizes.
[0037] In some examples, at least the walls 9 may be made of a flexible material, such as a plastic. The attachment portion 4 may be pushed onto the receiving instrument 1 because of the inherent flexibility of the walls 9. Once pushed into place, the two walls 9 may latch onto the receiving instrument 1 by the tendency of the walls 9 to return to their undeformed configuration. When it is desired to remove the device 3 from the receiving instrument 1, the device 3 may simply be pushed off.
[0038] Depending on the configuration of the portion of the receiving instrument 1 that to be attached at the attachment portion 4, the attachment portion 4 may have other configurations. For example, the walls 9 may be substantially parallel to each other, or the walls 9 may be in other arrangements (e.g., curved or slanted towards each other) to enable adequate attachment to the receiving instrument 1. Although the attachment portion 4 is shown in FIGS. 1-5 as having walls 9, the attachment portion 4 may include other configurations in addition to or in place of the walls 9 to enable the device 3 to be removably attached to the receiving instrument 1. [0039] FIGS. 1-5 show the walls 9 as formed in one piece with the body 8. In other examples, the attachment portion 4 and/or the walls 9 may be provided on the body 8 by other means (e.g., assembled from separate components).
[0040] The device 3 also includes a drive mechanism 5. In the example of FIGS. 1-5, the drive mechanism 5 includes two wheels 6. In general, the drive mechanism 5 may include greater or fewer number of wheels 6, as discussed further below. The device mechanism 5 is configured to advance the medical instrument 2 (e.g ., catheter or guidewire). In operation, the medical instrument 2 is frictionally engaged between the two wheels 6. In some examples the medical instrument 2 may be threaded in between the wheels 6 by an operator.
Alternatively, the medical instrument 2 may be disposed between the wheels by any suitable method. To advance or retract the medical instrument 2, the operator may turn at least one of the wheels 6.
[0041] In some examples, at least one of the wheels 6 may be configured with teeth, ridges or other patterns on a surface intended for contact with the medical instrument 2, to increase friction . The other wheel 6 may have the same, complementary or similar patterns on a surface intended for contact with the medical instrument 2. In some examples, each wheel 6 may have features complementary to each other (e.g., complementary teeth, protrusions and/or recesses), to enable rotation of one wheel 6 to drive rotation of the other wheel 6. In other examples, the wheels 6 may simply frictionally engage each other. In some embodiments, at least one of the wheels 6 may have an annular groove 11 around the outer surface intended contact with the medical instrument 2, as shown in FIG. 5. The groove 11 may be configured to partially receive the medical instrument 2 and to limit the movement of the medical instrument 2 when received. In some examples, the two wheels 6 do not contact each other, having a gap between the wheels 6 for receiving the medical instrument 2. The gap may be narrower than the diameter of the medical instrument 2, to enable a frictional engagement. The wheels 6 may be configured to ensure the medical instrument 2 is frictionally engaged therebetween, while avoiding excessive compression or damage to the medical instrument 2.
[0042] In some examples, at least one wheel 6 may be moveable to enable disengagement of the drive mechanism 5 from the medical instrument 2. For example, at least one wheel 6 may be readily removed from the drive mechanism 5. In the example of FIGS. 1-5, each wheel 6 is attached to the drive mechanism 5 by an axle 7. In some examples, as shown in FIG . 4, at least one axle 7 comprises two prongs 10 extending along the axis of rotation with a gap between the prongs 10. More prongs 10 may be used, for example, three, four or more prongs 10. The wheel 6 may be removed from the axle 7 by squeezing the prongs 10 together, or may be removed from the axle 7 by exertion of sufficient force.
[0043] In some examples, as shown in FIG. 4, the prongs 10 may have enlarged portions 12. The enlarged portions 12 may be located close to the ends of the prongs 8 away from the body 8, such that when the wheel 6 is fitted over the axle 7, the enlarged portions 12 limit the range of movement allowed for the wheel 6 and help to maintain the wheel 6 in place.
[0044] FIGS. 6 and 7 illustrate an example of the device 3 in which the drive mechanism 5 includes a single wheel 6. The wheel 6 may frictionally engage the medical instrument 2 against another surface or part of the device 3, such as a surface on the body 8. For example, there may be a projection (not shown) on the body 8 that urges the medical instrument 2 against a surface of the wheel 6. In some examples, the wheel 6 may be disposed so that the wheel 6 engages the medical instrument 2 against an upper surface of the body 8. In some examples, the wheel 6 and/or the surface of the body 8 against which the medical instrument 2 is intended to be engaged may have a groove for receiving the medical instrument 2. In the example of FIGS. 6 and 7, the wheel 6 may be removable from the drive mechanism 5 together with the axle 7. [0045] In some examples, the drive mechanism 5 may include three wheels 6. In such examples, two of the wheels 6 may be disposed to frictionally engage the medical instrument 2 therebetween, similar to that described above with reference to FIGS. 1-5. The third wheel 6 may engage one of the other two wheels 6 (e.g ., frictionally or via complementary features on the wheels 6) . The third wheel 6 may be turned to cause the other two wheels 6 to turn. It may be useful to provide the third wheel 6 so that the operator's action of rotating the third wheel 6 is more intuitively in agreement with the direction of the movement of the medical instrument 2.
[0046] In some examples, the drive mechanism 5 may be disengaged from the medical instrument 2 by removing at least one wheel 6 from the drive mechanism 5. For example, the wheel 6 may be removed from an axle 7 (e.g., as described with reference to FIGS. 1-5) or the wheel 6 may be removed together with the axle 7 (e.g., as described with reference to FIGS. 6-7) .
[0047] FIGS. 8 and 9 illustrate an example of the device 3 in which at least one wheel 6 may be moveable by sliding along a track 13 defined in the body 8. The wheel 6 may be slide into and out of engagement with the medical instrument 2, without having to remove the wheel 6 from the drive mechanism 5 (see FIG . 9) . The wheel 6 may also be removed from the drive mechanism 5 by sliding the wheel 6 out of the track 13 (see FIG. 8). [0048] In some examples, at least one wheel 6 may be tiltable relative to the body 8 to enable the drive mechanism 5 to engage and disengage the medical instrument 2. For example, at least one axle 7 that receives the wheel 6 may be moveable outwardly away from the medical instrument 2, thus allowing the medical instrument 2 to be released without disturbing the position of the medical instrument 2. When thus tilted, the wheels 6 no longer share a common plane.
[0049] In some examples, the device 3 may be integrated with the receiving instrument 1, while retaining the ability to engage and disengage the medical instrument 2 readily as described above.
[0050] In some examples, the device 3 may be configured to enable the device 3 to be inserted into the Tuohy needle, similar to a slip tip. An example of such a configuration is illustrated in FIG . 10. In this example, the attachment portion 4 is configured to snugly fit into the proximal end of the receiving
instrument 1, with an opening or gap to permit the medical instrument 2 to be threaded through into the receiving instrument 1. The drive mechanism 5 in FIG. 10 is illustrated as having two wheels 6, however any suitable configuration of the drive mechanism 5 may be used. [0051] FIGS. 11- 13 illustrate an example of the device 3 in which the body 8 may be moved between engaged and disengaged configurations to engage and disengage, respectively, the drive mechanism 5 from the medical instrument 2. The body 8 may be provided in two parts 8a, 8b, which may be individually attached to the receiving instrument 1. For example, each part 8a, 8b may have a respective attachment portion 4a, 4b to clip onto the proximal end of the receiving instrument 1. In some examples, the attachment portion 4a, 4b may include a hinge that may be removably or permanently attached to the receiving instrument 1.
[0052] In the example shown, the drive mechanism 5 includes two wheels 6, each wheel 6 being separately provided on a respective separate part 8a, 8b of the body 8. In FIG. 12, the body 8 is in the disengaged configuration, in which the wheels 6 are moved apart from each other. In this configuration, the drive mechanism 5 can be disengaged from the medical instrument (not shown) . The separate parts 8a, 8b of the body 8 can be brought together into the engaged configuration (see FIG. 13), for example by pivoting the parts 8a, 8b on the hinge of the attachment portion 4a, 4b. In the engaged configuration, the wheels 6 of the drive mechanism 5 can frictionally engage the medical instrument (not shown) to enable advancement/retraction of the medical instrument, as described above. The parts 8a, 8b of the body 8 may be provided with a fastening mechanism (e.g., complementary parts of an interlocking system, such as a snap-fit) to ensure the body 8 stays in the engaged configuration. Although FIGS. 11-13 illustrate the drive mechanism 5 having two wheels 6, it should be understood that the drive mechanism 5 may have fewer or greater number of wheels 6, as discussed above.
[0053] FIGS. 14- 17 illustrate another example of the device 3. In this example, the body 8 includes a pivotable portion 8c that pivots relative to the main body 8, to enable the body 8 to move between engaged and disengaged
configurations. FIGS. 14- 17 show the example device 3 in the disengaged configuration .
[0054] One wheel 6 of the drive mechanism 5 is mounted on the pivotable portion 8c and the other wheel 6 is mounted on the main body 8. Each wheel 6 may have protrusions, teeth or other complementary feature that engage with each other, when in the engaged configuration, to help ensure that the wheels 6 are aligned and/or that rotation of one wheel 6 causes rotation of the other wheel 6. In this example, the annular groove 11 of each wheel 6 has a concave profile, so that, when in the engaged configuration, the grooves 11 together define a passage for the medical instrument 2 to be threaded therethrough. The grooves 11 may be configured such that they define a passage that is slightly narrower than the diameter of the medical instrument 2, to ensure that the medical instrument 2 is frictionally engaged, without excessively compressing the medical instrument 2. Other configurations, including convex or flat profiles, may also be possible. [0055] In this example, the wheels 6 may be designed to not be removable from the body 8. Instead of axles 7 mounting the wheels 6, each wheel 6 may be provided with a post 14. Each post 14 may rotate with the respective wheel 6, or may be stationary when the respective wheel 6 rotates. The posts 14 may be configured with a rounded surface, as in the example shown, to improve comfort and ergonomics when the device 3 is held by an operator. In some examples, the posts 14 may be omitted.
[0056] The pivotable portion 8c may be provided with a clip 15 or other fastening mechanism to enable the pivotable portion 8c to be fastened to the main body 8 when in the engaged configuration . This may help to ensure that the pivotable portion 8c does not accidentally disengage from the engaged
configuration . In the example shown, the clip 15 may fit over the side of the main body 8. In other examples, the clip 15 may fit into a recess defined on the underside of the main body 8. Other fastening mechanisms may be used, or the fastening mechanism may be omitted.
[0057] Engagement of the pivotable portion 8c with the main body 8 may also be assisted by a protrusion 16 of the pivotable portion 8c that fits into a recess 17 defined in the main body 8 when in the engaged configuration. The protrusion 16 and recess 17 may engage each other in a friction fit, for example, and may help to ensure that the pivotable portion 8c does not accidentally disengage from the engaged configuration. The protrusion 16 and recess 17 may also help to ensure the wheels 6 are aligned with each other when in the engaged configuration. In some examples, the protrusion 16 may be provided on the main body 8 and the recess 17 may be defined in the pivotable portion 8c instead. In some examples, other complementary features may be used instead of protrusion 16 and recess 17, for example bumps and recesses that fit with each other, but not necessary engage in a friction fit. The protrusion 16 and recess 17 may thus provide another fastening mechanism for maintaining the body 8 in the engaged configuration . In some examples, only the protrusion 16 and recess 17 may be provided and the clip 15 omitted; in other examples, only the clip 15 may be provided and the protrusion 16 and recess 17 omitted; in other examples, the clip 15 as well as the protrusion 16 and recess 17 may be omitted; in other examples, one or more other fastening mechanisms may be used . [0058] The device 3 may be provided with the pivotable portion 8c already pivotably attached to the main body 8. In other examples, the device 3 may be provided with the pivotable portion 8c separate from the main body 8 and these pieces may be attached together by the operator.
[0059] In some examples, the device 3 may be configured (e.g. , with an open top) to enable visualization of the medical instrument 2 when it is engaged in the device 3.
[0060] Examples of the device 3 may be provided as a kit together with the receiving instrument 1 (e.g., Tuohy needle) and medical instrument 2 (e.g. , nerve catheter or guidewire). The kit may be provided for a regional anaesthesia procedure, ultrasound guided vascular access, placement of a guidewire or catheter, or other similar procedure. The device 3, along with the entire kit, may be sterilizable and/or disposable.
[0061] Although certain examples of the device 3 have been described, it should be understood that variations are possible within the scope of this disclosure. For example, features described with respect to a particular example may be used in combination with another example.
[0062] The catheter advancement device, as described in various examples herein, may be attached to a receiving instrument (e.g., Tuohy needle) after the receiving instrument has been positioned in the patient (e.g. , with assistance from ultrasound guidance). The medical instrument (e.g., catheter or guidewire) to be advanced may then be engaged by the catheter advancement device. The operator may advance the medical instrument by manipulating the drive mechanism, for example using one hand while holding an ultrasound probe with the other hand. In this way, ultrasound guidance can be maintained when advancing the medical instrument. Once the medical instrument is advanced to a desired position, the drive mechanism may be disengaged from the medical instrument and the device may be detached, all while the inserted medical instrument is undisturbed.
[0063] In some examples, the catheter advancement device may be incorporated into the receiving instrument (e.g., formed together with the proximal end of the receiving instrument), and may not be removable from the receiving instrument. In such a configuration, the device still enables the medical instrument to be advanced or retracted by manipulating the drive mechanism using one hand, and enables the medical instrument to be engaged or disengaged from the drive mechanism at any time without disturbing the position of the medical instrument. Where the device is incorporated into the receiving instrument, the device does not require an attachment portion and would not need to be attached to the receiving instrument during the medical procedure.
[0064] Although described in the context of certain medical instruments and certain medical procedures, it should be understood that the present disclosure is not limited to such examples. The disclosed catheter advancement device may be used for placement of any wire, catheter or similar medical instrument, and may be used for any procedure involving placement of such instruments. For example, the present disclosure may be applicable for placement of a wire for access to blood vessels and/or hollow organs, such as in the Seldinger technique under ultrasound guidance. [0065] The embodiments of the present disclosure described above are intended to be examples only. The present disclosure may be embodied in other specific forms. Alterations, modifications and variations to the disclosure may be made without departing from the intended scope of the present disclosure. While the systems, devices and processes disclosed and shown herein may comprise a specific number of elements/components, the systems, devices and assemblies could be modified to include additional or fewer of such elements/components. For example, while any of the elements/components disclosed may be referenced as being singular, the embodiments disclosed herein could be modified to include a plurality of such elements/components. Selected features from one or more of the above-described embodiments may be combined to create alternative embodiments not explicitly described. All values and sub-ranges within disclosed ranges are also disclosed. The subject matter described herein intends to cover and embrace all suitable changes in technology. All references mentioned are hereby incorporated by reference in their entirety.

Claims

1. A device for advancement of a medical instrument, the device comprising :
a body;
a drive mechanism provided on the body for advancing the medical instrument in a receiving instrument, the drive mechanism comprising at least one wheel for frictionally engaging the medical instrument, the at least one wheel being moveable to enable disengagement of the drive mechanism from the medical instrument.
2. The device of claim 1 wherein the drive mechanism comprises a single wheel for frictionally engaging the medical instrument against a surface of the body.
3. The device of claim 1 wherein the drive mechanism comprises two wheels for frictionally engaging the medical instrument therebetween.
4. The device of claim 3 wherein the drive mechanism further comprises a third wheel for driving the two wheels.
5. The device of claim 3 or 4 wherein each wheel comprises features
complementary to features of each other wheel, to enable alignment of the wheels with each other.
6. The device of any one of claims 3 to 5 wherein each of the two wheels have a respective groove that together define a passage for the medical instrument.
7. The device of any one of claims 1 to 6 wherein the at least one wheel is removable from the drive mechanism to enable disengagement of the drive mechanism from the medical instrument.
8. The device of any one of claims 1 to 6 wherein the at least one wheel is moveable along a track defined in the body to enable disengagement of the drive mechanism from the medical instrument.
9. The device of any one of claims 1 to 6 wherein the at least one wheel is tiltable relative to the body to enable disengagement of the drive mechanism from the medical instrument.
10. The device of any one of claims 1 to 6 wherein the body is moveable between a disengaged configuration and an engaged configuration, wherein the at least one wheel is moveable to enable disengagement of the drive mechanism by moving the body to the disengaged configuration.
11. The device of claim 10 wherein the body comprises at least one fastening mechanism to fasten the body in the engaged configuration.
12. The device of any one of claims 1 to 11 wherein the body comprises an attachment portion for attaching the device to the receiving instrument.
13. The device of claim 12 wherein the attachment portion is configured to be insertable into a proximal end of the receiving instrument.
14. The device of any one of claims 1 to 11 wherein the body is incorporated into a proximal end of the receiving instrument.
15. A kit comprising :
the device of any one of claims 1 to 14;
the medical instrument; and
the receiving instrument.
16. The kit of claim 15 wherein the receiving instrument is a Tuohy needle.
17. The kit of claim 15 or claim 16 wherein the medical instrument is a catheter.
18. The kit of any one of claims 15 to 17 wherein the kit is for a regional anaesthesia procedure.
19. The kit of claim 15 or claim 16 wherein the medical instrument is a guidewire.
20. A method of advancing a medical instrument, the method comprising:
positioning a receiving instrument in a patient;
providing the device of any one of claims 1 to 14 at a proximal end of the receiving instrument; engaging the drive mechanism of the device with the medical instrument; and
advancing the medical instrument in the receiving instrument to a desired position, using the drive mechanism.
21. The method of claim 20, further comprising :
disengaging the drive mechanism from the medical instrument while the medical instrument is at the desired position.
22. The method of claim 20 or claim 21 wherein the receiving instrument is a Tuohy needle.
23. The method of any one of claims 20 to 22 wherein the medical instrument is a nerve catheter.
24. The method of any one of claims 20 to 22 wherein the medical instrument is a guidewire.
PCT/CA2017/051110 2016-09-22 2017-09-21 Catheter advancement device WO2018053633A1 (en)

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US62/398,234 2016-09-22

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WO2006085331A2 (en) * 2005-02-14 2006-08-17 Flexicath Ltd. Method and apparatus for inserting a catheter device

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WO1994016762A1 (en) * 1993-01-25 1994-08-04 Imagyn Medical, Inc. Controller for manipulating instruments within a catheter
WO2000012167A1 (en) * 1998-08-26 2000-03-09 Microcatheters Pty. Ltd. Catheter guide
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