Wire and catheter placement device

Abstract

A guidewire introduction system includes a housing body, a sheath retainer, and an actuator operably connected to the housing body and to the sheath retainer. The actuator is configured to move between a first position and a second position, where the sheath retainer is configured to retain the sheath in the first position and where the sheath retainer is configured to release the sheath in the second position.

Description

WIRE AND CATHETER PLACEMENT DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 675,018, filed July 24, 2024. The disclosure of the prior application is considered part of (and is incorporated by reference in) the disclosure of this application.TECHNICAL FIELD

[0002] This disclosure describes systems, devices, and methods for the introduction of elongate instruments including catheters, guidewires, and other instruments and more particularly to the introduction of catheters, guidewires, and other instruments into small diameter blood vessels, deep vessels, central veins, arteries, and those visualized by ultrasound.BACKGROUND

[0003] Catheter introduction systems can be used to insert and guidewires, catheters, and other instruments into vessels of a subject. Catheter introduction sets can involve the use of two hands (e.g., both of the user’s hands) to operate the device. One hand is utilized to insert a needle and catheter, and a second hand to feed the guidewire. In imaging implementations such as ultrasonic imaging, the user removes one hand from the imaging probe to feed the guidewire. Consequently, a single user cannot visualize the guidewire directly while advancing and guiding a guidewire or other instrument, which increases the possibility of misplacement of the guidewire or other instrument. A procedure can include insertion and navigation of a guidewire to a target area, and subsequent treatment at that area involving one or more additional instruments that can be exchanged over the wire.SUMMARY

[0004] This disclosure describes systems, devices, and methods for the introduction ofelongate instruments including catheters, guidewires, and other instruments. In particular implementations, the systems, devices, and methods described herein can include a wire introduction system that facilitates precise control of the wire and additionally facilitates interchanging of other instruments while maintaining control of the position of the guidewire.

[0005] Among other benefits, some systems and methods described herein can advantageously provide a secure and controlled approach to introducing a wire and other instruments into vessels of a subject. Additionally, some embodiments described in more detail below can achieve an efficient and secure solution to removing and interchanging devices over a guidewire while maintaining a position of the guidewire. Some embodiments described in more detail below can achieve an efficient and secure approach to removing a guidewire from the introducer system.

[0006] Some embodiments described herein include a wire introduction system for introducing a guidewire into a body of a patient. The system can include a housing body including a rear opening, a sheath configured to extend through the rear opening and over the guidewire to connect to the housing body, an actuator coupled with the housing and configured to translationally engage and disengage with a distal end of the sheath, wherein in an engaged position, the actuator restricts removal of the sheath from the rear end opening, and wherein, in an unengaged position, the actuator facilitates removal of the sheath from the rear housing opening, and a pin assembly connected to the housing body and including a pin configured to engage and disengage contact with the guidewire.

[0007] Such a system can include one or more of the following optional features. The sheath is configured to apply compression forces to the pin to engage contact between the guidewire and a drive wheel. Responsive to removal of the sheath, the compressive forces are removed from the pin and the pin disengages contact between the guidewire and drive wheel. The pin assembly is spring-loaded such that, responsive to compressive forces at a pin arm from thedistal end of the sheath, the pin arm actuates the pin to engage contact betw een the guidewire and the drive wheel. The pin assembly is spring-loaded such that, responsive to a removal of compressive forces at a pin arm from the distal end of the sheath, the pin arm actuates the pin to disengage contact between the guidewire and the drive wheel. Disengagement of the drive wheel and the guidewire prevents advancement of the guidewire by the drive w heel. Disengagement of the drive wheel and the guidewire permits removal the guidewire from the patient and the wire introduction system. With the actuator in an engaged position, the sheath is configured to be removed, the compressive forces from the sheath at the pin assembly are configured to be removed, and the drive wheel is configured to be disengaged from the guidewire. With the actuator in a disengaged position, the sheath is restricted from removal, the sheath applies compressive forces at the pin assembly, and the drive wheel is engaged with the guidewire. The actuator comprises an actuator key that is configured to engage with a notch in the distal end of the sheath. In the engaged position, the actuator key is engaged with the notch. In the disengaged position, the actuator key is translated past and disengaged with the notch. The actuator comprises an actuator channel, the sheath is configured to extend through the actuator channel in both the engaged and disengaged positions. The actuator is spring-biased into the disengaged position. The system includes one or more guides positioned inside the housing body to guide and support the guidewire. The system includes a front opening at a front end of the housing body, wherein the guidewire extends through the front opening and the rear opening. The housing body has a front end portion projecting forward from the housing and configured to receive a needle having a central opening, wherein the guidewire extends through the central opening of the needle. The system is configured for single-handed operation, whereby a user can hold the system in a single hand and operate the a drive wheel with an index finger of the hand. The system includes a guide wheel rotatably coupled with the housing body, and a drive wheel rotatably coupled with thehousing and rotatably engaged with the guide wheel, the drive wheel coupled with the guidewire and configured to advance the guidewire into the patient body upon rotation of said guide wheel. The guide wheel has teeth and the drive wheel has teeth, wherein the guide wheel teeth are engaged with the drive wheel teeth.

[0008] Some embodiments described herein include a sheath removal method. The method includes receiving a sheath within a housing body at a sheath retainer, restraining the sheath from translational motion with an actuator in a first position, moving the actuator from a first position to a second position, and releasing the sheath from the sheath retainer with the actuator in the second position.

[0009] Such a method can include one or more of the following optional features. The method can include extending a guidewire through a housing body. The actuator is biased into the first position. The method can include compressing a pin into engagement with a guidewire and a drive wheel.

[0010] Some embodiments described herein include a guidewire release method. The method can include extending a guidewire through a housing body, compressing a pin into engagement with the guidewire and a drive wheel with the pin in a first position, moving the pin from the first position into a second position, releasing the engagement between the guidewire and the pin, and removing the guidewire from the housing body.

[0011] Some embodiments described herein include a guidewire fixation method. The method can include extending a guidewire through a housing body, compressing a pin into engagement with the guidewire and a drive wheel with the pm in a first position, and restraining the guidewire from translation during engagement between the pin and the guidewire.

[0012] Some embodiments include a guidewire introduction system for introducing a guidewire into a body of a patient. The system can include a housing body, a sheath retainer.and an actuator operably connected to the housing body and to the sheath retainer, wherein the actuator is configured to move between a first position and a second position, wherein the sheath retainer is configured to retain a sheath in the first position and wherein the sheath retainer is configured to release the sheath in the second position.

[0013] Such a system can include one or more of the following optional features. The actuator comprises a button, a switch, a slider, or a lever.

[0014] Some embodiments include a guidewire introduction system for introducing a guidewire into a body of a patient. The system incudes a housing body, a wheel positioned in the housing body, a pin positioned in the housing body, and an actuator operably connected to the housing body and to the pin, wherein the actuator is configured to move between a first position and a second position to move the pin from a first pin location proximate the wheel in the first position to a second pin location further from the wheel in the second position.

[0015] Such a system can include one or more of the following optional features. The actuator comprises an arm extending from the pin to an arm location proximate a receptacle configured to receive a sheath. The system can include a sheath, wherein the actuator extends between the sheath and the pin such that removal of the actuator from the housing body facilitates the actuator moving from the first position to the second position to move the pin from the first pin location to the second pin location.

[0016] Some embodiments include a guidewire introduction system for introducing a guidewire into a body of a patient. The system can include a housing body defining a guidewire path, and an actuator operably connected to the housing body, a sheath retainer, and a pin, wherein the actuator is configured to move between a first position and a second position, wherein the sheath retainer is configured to retain the sheath in the first position and wherein the sheath retainer is configured to release the sheath in the second position, wherein the pin is configured to move from a first pin location proximate the wheel in the firstposition to a second pin location further from the wheel in the second position.

[0017] Some embodiments include a guidewire introduction system configured to release a sheath in response to actuation of a button, switch, or other actuator.

[0018] Some embodiments include a guidewire introduction sy stem configured to move a guidewire retention pin away from a wheel in response to removal of a sheath from a housing body.

[0019] Some embodiments include a guidewire introduction system configured to fix a guidewire in position in response to actuation of a button, switch, or other actuator.

[0020] Such a system can include one or more of the following optional features. The button, switch, or other actuator controls a position of a sheath in relation to a guidewire retention pin.

[0021] Particular implementations can, in certain instances, realize one or more of the following advantages. The systems, devices, and methods described herein can be operated by one hand to advance a guidewire, a catheter, and other instruments. The single-handed use of the device facilitates user comfort and flexibility to perform other operations with a free other hand. The systems, devices, and methods herein can facilitate improved patient outcomes and medical treatment by making IV placement more efficient and more accurate, and reducing pain. Additionally, the systems, devices, and methods facilitate fixation of a guidewire in position, removal of a sheath, and deactivation of a gear and drive wheel based on interaction with an actuator at the handle. These steps can enhance a user’s control of the system and provide the user with additional flexibility to utilize and exchange additional instruments over the guidewire. The guidewire can also be removed from the system, when controlled by the user to disengage the guidewire.DESCRIPTION OF DRAWINGS

[0022] FIG. 1 is a side view of an introducer system, consistent with some embodiments ofthis disclosure.

[0023] FIG. 2 is a perspective cross-sectional view of the introducer system of FIG. 1.

[0024] FIG. 3 is a perspective view of the introducer system of FIG. 1, with the cover show n separate.

[0025] FIG. 4 is a side view of the introducer system of FIG. 1.

[0026] FIG. 5 is another side view of the introducer system of FIG. 1.

[0027] FIG. 6 is another side view of the introducer system of FIG. 1.

[0028] FIG. 7 is a perspective view of an actuator of the introducer system of FIG. 6.

[0029] FIG. 8 is a perspective cross-sectional view of the actuator of FIG. 7 in a disengaged position.

[0030] FIG. 9 is a perspective cross-sectional view of the actuator of FIG. 7 in an engaged position.

[0031] FIG. 10 is a perspective cross-sectional view of the actuator of FIG. 9 with a sheath partially removed.

[0032] FIG. 11 is a cross-sectional view' of the introducer system of FIG. 6 w ith the actuator in the position of FIG. 8.

[0033] FIG. 12 is a cross-sectional view' of the introducer system of FIG. 6 w ith the actuator in the position of FIG. 10.

[0034] Like reference symbols in the various drawings indicate like elements.DETAILED DESCRIPTION

[0035] Referring to FIGS. 1-6, an introducer system 600 is shown in accordance with another embodiment of the invention. The system 600 generally includes a housing 602. a drive wheel assembly 610. one or more retainer assemblies 640, 650. 660, a leaf spring assembly620, and an actuator 670.

[0036] The housing 602 includes a front end housing 604 and a rear end housing 606. The rear end housing 606 of the housing 602 has a curved ergonomic shape to be easily grasped and held by a user with the palm about the rear end housing 606 and the finger (such as the index finger) or thumb resting on or about the guide wheel assembly 610. The housing 602 has an internal space that houses the components and protects the user from interfering with the operation of those components or being injured.

[0037] The drive wheel assembly 610 has two drive wheels 61 la, 61 lb and a spacer plate 613. The drive wheel assembly 610 is positioned at an opening formed at the front end 604 of the housing 602 and extends to a top of the housing 602. The drive wheel assembly 610 is aligned so that it rotates in a direction Y that is parallel to the longitudinal axis of the system 600. The drive wheel assembly 610 can be centered with respect to the width of the housing 602 so that the drive wheel assembly 610 is aligned with the central longitudinal axis of the system 600. The drive wheel assembly 610 has two wheels 611 that can be rotated by the user in the direction Y, which is toward the forward end 604 and away from the user. The drive wheels 611 each have a number of teeth 612 positioned along its outer circumference, with channels 614 formed between the teeth 12. The teeth 612 provide a tactile response and friction for the user to better rotate the drive wheels 611. The outer edges of the teeth 612 are slightly rounded so that they are comfortable to push by the user, and can be coated with a rubber or other material that enhances the user’s ability to grip the teeth 612 with a finger or thumb.

[0038] The spacer plate 613 extends outward from the inward-facing side of a first wheel 611a. The spacing plate 613 defines a space or gap 615 between the two wheels 6 I la. 61 lb having a distance sufficient to facilitate the guidewire 603 to pass between the two wheels 611a. 61 lb unobstructed. Accordingly, the plate 613 can be wider than the diameter of the guidewire 603. The spacer plate 613 has an outer diameter that is smaller than the outerdiameter of the wheels 611, so that the gap 615 is formed and the guidewire 603 can pass between the two wheels 61 la, 61 lb. The two wheels 61 la, 61 lb can be separate from one another, as shown. Alternatively, the wheel assembly 610 can be a single integral piece, whereby the two wheels 61 la, 61 lb are integrally formed with the center spacer plate 613. In some embodiments, the wheel assembly 610 can have a single wheel and the guidewire 603 can pass to the side of the single wheel. In addition, w hile the wheel assembly 610 is described as having two wheels 61 la, 611b and a spacer plate 613, some embodiments can include a single integral wheel having a central channel.

[0039] A drive wheel 616 is provided adjacent to the guide wheel assembly 610. The drive wheel 616 has teeth 618 and a wheel plate 617 and is formed as a single integral member. The teeth 618 interlock with and cooperatively engage the teeth 612 of the first wheel 61 la. In some embodiments, responsive to rotation of the drive w heel 611a, the guide wheel teeth 612 operate the drive wheel teeth 618 to rotate the drive wheel 616. The wheel plate 617 has an outer facing surface extending about the outer circumference of the plate 617. A rubber gasket 619 is positioned about the outer surface (or the outer surface can be made of rubber or coated with a rubber material). The outer surface or rubber gasket 619 contacts and engages the guidewire 603. The rubber material of the rubber gasket 619 grips the guidew ire 603 so that when the drive wheel 616 moves, the rubber gasket 619 pushes the guidewire 603 forward (to the left in the embodiment of FIGS. 1-5) out of the system 600. Thus, the guidewire 603 moves in the same direction Y that the user moves the guide wheel 610.

[0040] The guide wheel 610 and the drive wheel 616 are each rotatably mounted to the interior sides of the housing 602 by respective pins. The pins can be fixed to or formed at the outer-facing side of the wheels 61 la, 61 lb, and both outer-facing sides of the drive wheel 616 and extend transversely outward with respect to the outer-facing sides of the wheels 61 la. 611b, 616. The pins are received in mating circular openings formed in the sides of thehousing 602. For instance, the channels can be formed directly in the side of the housing, or formed in a support member that projects outward from the side (inward with respect to the housing). The pins can rotate within the circular openings so that the wheel assembly 610 and the drive wheel 616 can freely rotate with respect to the housing 602.

[0041] A leaf spring assembly 620 is provided adjacent the drive wheel 616. The leaf spring assembly 620 has a bracket 625 and a leaf spring 628. The bracket 625 attaches the assembly 620 to the inside of the housing 602. The leaf spring 628 is an elongated and thin piece of metal. The leaf spring 628 extends from the bracket 625 toward the drive wheel 616. In some embodiments, the leaf spring 628 is aligned with the drive wheel teeth 618 and the distal end of the leaf spring 628 extends into the channels between the drive wheel teeth 618. The leaf spring 628 can include a rigid material, such as steel, and the leaf spring 628 can be thin and narrow so that the spring 628 moves from channel to channel between the teeth as the drive wheel 616 advances. That action provides an auditor}' click and a tactile measure of movement. The leaf spring 628 can be formed integral with the bracket 625 and bent at a right angle so that the bracket 625 can be screwed to posts 622 that extend from the side and / or top of the housing 602, as shown. Spring mounts 626 can be provided that keep the spring 628 properly positioned and support the spring 628. The mount 626 has a groove that receives the spring 628.

[0042] In addition, the spring 628 can be utilized to prevent backward motion of the guidewire 603. The stiffness of the spring 628 material (and / or curvature of the spring 628) prevents the spnng 628 from bending in a backward direction, which in turn prevents backward movement of the drive wheel 616 by preventing the teeth 618 from moving in reverse beyond the spring 628. Thus, the user cannot inadvertently rotate the guide wheel assembly in a reverse direction to the forward direction Y, since the spring 628 prevents that operation via its interaction with the drive wheel 616. It is noted, however, that the drivewheel 616 is not under tension from a drive wire (since there is no drive wire), so there is no tension on the guidewire 603 to move in reverse.

[0043] In some embodiments, the retainer or guide assemblies 630, 640, 650, 660 can be positioned along the length of the guidewire 603 inside the housing 602. The guide assemblies 630, 640, 650, 660 have arms that form ribs 634, 644, 654, 664, respectively. The guide ribs 634, 644, 654, 664 extend about the guidewire 603 and provide support for the guidewire 603 at various points in the housing 602 to keep the guidewire 603 from slipping or moving off of the drive assembly 616. For instance, the rib 634 extends entirely around the sheath 601 to support the sheath 601 and the wire 603 inside the sheath 601, and hold them in place. The rib 644 can be positioned near the sheath 601 and extend completely around the wire 603 with the wire 603 extending through an opening in the rib 644. The rib 654 can be to both the sides (with one rib 654 show n to one side) of the guidewire 603, and the rib 664 can be beneath the wire 603. The ribs 634, 644, 654, 664 can be made of polycarbonate, polyeurethane or ABS. The ribs can be are molded features of the housing, and not separate pieces.

[0044] In addition, a contact peg 652 can be provided to hold the guidewire 603 in place against the drive w eel 616 and gasket 619. The peg 652 can be provided at the top of the post that holds the rib 654. The peg 652 is aligned with the drive wheel 616, so that the guidewire 603 is positioned between the drive wheel gasket 619 and the outer circumferential surface of the peg 652. The peg 652 can be rotatably mounted to at the top of the post so that the peg 652 rotates as the guidewire 603 moves. The outer surface of the peg 652 can be made of or coated with rubber material or have a rubber gasket. The peg 652 is positioned between two posts that are respectively coupled with the sides of the housing, though only one post is shown on the housing halves in the embodiments of FIGS. 2-3. The peg 652 and drive wheel 616 prevent the guidewire 603 from moving up / down in the embodimentsshown, and the ribs 654, 664 prevent the guidewire 603 from moving in / out of the apparatus in the embodiments shown. Any suitable number of ribs and pegs can be provided, having any suitable shape, to keep the guidewire 603 properly positioned.

[0045] The front end housing 604 extends forward from the rear end housing 606. The front housing 604 is generally tubular. A support plate 696 is provided at the back side of the front end housing 604. The support plate 696 has a central opening through which the guidewire603 extends. A spring 694 is positioned next to the support plate 696. The spring 694 pushes against the support plate 696 and the support plate 696 supports the spring 694 to allow the spring 694 to compress and expand.

[0046] A needle mating apparatus is provided at the front end housing 604. The needle mating apparatus includes a needle mating tip 680, a slip connector 682, and a spring 694. The needle mating apparatus is configured to receive and mate w ith a needle assembly 700. The needle assembly 700 includes a needle 704, a cannulated housing or flash chamber 701 and a hub 706. The flash chamber 701 is tubular and has a front end portion that mates with the hub 706 and rear end portion that mates with the slip connector 682. The needle mating tip 680 extends inside the flash chamber 701 and mates with the needle 704.

[0047] The slip connector 682 is a single piece device that has a front end portion, midportion and rear end portion. The front end portion of the connector 682 extends out of the front end housing 604, is elongated and tapered inward from the proximal end to the distal end. The front portion and the mid-portion of the slip connector 682 share the same internal bore. The mid-portion is received inside the front end housing 604. A channel is provided about the outer circumference of the slip connector 682 at the mid-portion of the slip connector 682. The channel receives a mating lock protrusion 683 in the front end housing604 to keep the slip connector 682 in place within the front end housing 604. The mating lock protrusion 683 extends inwardly from the interior side wall of the front end housing 604.Thus, the slip connector 682 is locked to the front end housing 604 so that it does not move. The mid-portion and the rear end portion of the slip connector 682 share the same outer diameter, which is larger than the outer diameter of the front portion of the slip connector 682. The rear end portion of the slip connector 682 has an interior central bore that has a wider diameter than the internal bore of the mid-portion and front end portion of the slip connector 682, forming a lip 691 therebetween.

[0048] The needle mating tip 680 is an elongated one-piece member having a front end portion and a rear end portion. The front end portion is elongated and has a uniform outer diameter and a central bore extending therethrough. The rear end portion has a larger outer diameter than the front end portion and has an angled surface 681 that is angled downward from the rear end portion to the front end portion.

[0049] The rear end portion 684 of the needle tip 680 has a channel that receives a gasket 690. The gasket 690 is made of rubber to prevent fluid from passing. The guidewire 603 passes through the gasket 690 and prevents blood or fluid from flowing back into the housing 602 during operation. Another rubber gasket can be fitted about the guidewire 603 and stay inside the rear end of the needle mating tip 680 to further prevent blood or fluid from flowing back into the housing 602 during operation. The proximal or rear end portion 684 of the needle tip 680 has a reduced end portion that forms an internal lip 688. The spring 694 extends around the reduced end portion inside the slip connector 682 and pushes against the lip 688. Thus, the spring 694 biases the needle tip 680 outward and compresses inward when the needle tip 680 is pushed by the user, to ensure that the needle connector 680 remains properly mated with the needle.

[0050] A central bore extends through the needle mating tip 680 to receive the guidewire 603. The rear end portion of the needle mating tip 680 has an enlarged internal central bore with a gasket 692. The gasket 692 is made of rubber and also prevents blood or fluid fromflowing back into the housing 602. The enlarged bore section can be tapered to guide the guidewire 603 through the needle mating tip 680.

[0051] The mating tip 680 is at least partially positioned inside the slip connector 682. More specifically, the elongated front end portion of the needle mating tip 680 extends through the central bore of the front end portion and mid-portion of the slip connector 682. The rear end portion of the needle mating tip 680 remains in the rear end portion of the slip connector 682. The spring 694 pushes against the lip 688 of the reduced outer rear end portion of the slip connector 682 to bias the needle mating tip 680 forward in the slip connector 682. The spring 694 can push the needle mating tip 680 to the forward-most position, where the angled surface 681 of the needle mating tip 680 contacts the lip 691 of the slip connector 682, as shown.

[0052] Thus, the slip connector 682 receives the needle mating tip 680 and restricts, restrains, or prevents the needle mating tip 680 from falling out of the front end housing 604. In addition, the slip connector 682 facilitates inward and outward movement of the needle mating tip 680 under force of the spring 694.

[0053] Referring to FIGS. 4 and 5, the flash chamber 701 is frictionally fit to the slip connector 682. More specifically, the rear end of the flash chamber 701 slides over the top of the front end portion of the needle mating tip 680 and is frictionally received by the outer surface of the tapered front end portion of the slip connector 682. When the needle assembly 700 is fit to the slip connector 682, the internal bore of the needle mating tip 680 is aligned with the distal end 705 of the needle 704, which protrudes backward from the inside of the hub 706. The distal end 705 enters a small hole 685 in the nose of the needle mating tip 680. The hole 685 is tapered inward to guide the needle end 705 toward the bottom of the hole 685. Accordingly, the guidewire 603 is aligned with the proximal rear end 705 of the needle 704. Thus, when the user moves the guide wheel assembly 610 forward in direction Y, theguidewire 603 moves forward in the needle mating tip 680 into the central bore of the needle 704.

[0054] In some embodiments, the distal end of the needle mating tip 680 is aligned with and abuts or nearly abuts the extreme proximal end of needle 704, so that that guidewire 603 can enter the needle 704 without stubbing the needle 704. The needle mating apparatus is able to mate with flash chambers 701 of different lengths. When the flash chamber 701 is pressed onto the slip connector 682, the flash chamber 701 can push the needle mating tip 680 backward or inward into the front housing 604 against the force of the spring 694. The amount that the needle mating tip 680 is pushed is dependent on the length of the flash chamber 701. A longer flash chamber 701 will not push the mating tip 680 very far, and shorter flash chambers 701 will push the mating tip 680 further. The spring 694 ensures that the needle end 705 remains reliably seated in the hole 685 and abutted against the bottom of the hole 685 of the needle mating tip 680 and that the needle end 705 is aligned with the central bore of the needle mating tip 680.

[0055] Referring to FIGS. 1-6, a sheath 601 is positioned outside the housing 602 and extends into an opening at the rear end housing 606. The sheath 601 protects the guidewire603. The guidewire 603 extends through the sheath 601, the housing 602 and the male end connector 680. More specifically, the guidewire 603 extends through the entire housing 602. It enters together with the sheath 601 through an opening in the rear end housing 606. The sheath 601 terminates once inside the housing 602, and the wire 603 continues from the rear end housing 606 to the front end housing 604. where it is supported by the guides 630. 640, 650, 660 and passes through the gap 615 in the wheels 61 la, 61 lb. At the front end housing604, the wire 603 passes through the support plate 696 opening, through the spring, and into the enlarged bore at the rear end portion of the needle mating tip 680. The guidewire 603 then passes through the central bore of the needle mating tip 680 and out of the front of thetip 680. As the wire 603 passes through the rear end housing 606, it extends through the retainer assemblies 630, 640, 650, 660, and between the drive wheel 616 and the peg 652.

[0056] Referring to FIGS. 1-7, the system 600 includes the actuator 670. The actuator 670 is operably connected to the housing 602. In some embodiments, the actuator 670 is operably connected to the housing 602 at the rear end housing 606. The actuator 607 is configured to engage and disengage with a distal end of the sheath 601. Engagement of the actuator 670 and the distal end of the sheath 601 restrains the sheath 601 in position. Disengagement of the actuator 670 and the distal end of the sheath 601 facilitates a release of the sheath 601 from the housing 602.

[0057] The actuator 670 can be positioned along the housing 602 such that a user operates the system 100 with a single-hand. For example, the user can actuate and engage with both the drive wheel 611 and the actuator 670 using one hand. The process of exchanging instruments along with securing the guidewire in position can be difficult to manage and can involve multiple hands to secure the guidewire and other instruments in position. This process can be insecure and increase total procedure time. Single-handed operation of the system 600 advantageously frees another hand of the user, improves security of the system 600 and associated instruments (e.g., guidewire 603, sheath 601, and other instruments that can be exchanged over the guidewire 603). In some embodiments, the actuator 670 can be positioned along a side of the rear end housing 606 and aligned with a longitudinal axis of the system 600 such that the actuator 670 is aligned with the guidewire 603 and the sheath 601 (in examples where the sheath 601 is present).

[0058] The system 600 can be made of a plastic (e.g.. medical grade polymers and UV cure adhesives), and the guidewire 603 can include a metal (such as stainless steel, 300 series). The entire introducer can be sterilized and packaged in a sterilized container, such as being heat sealed in a plastic bag.

[0059] In operation, the slip connector 682 and needle mating tip 680 are inserted into the tubular front end housing 604 and locked in place. The needle mating tip 680 is advanced to the point at which the needle mating tip 680 comes into contact with the back end of the needle. This mating tip then slides through the slip connector 682. The spring 694 keeps the tip flush against the needle to guide the wire 603 during normal operation. As show n in FIGS. 4 and 5, the needle assembly 700 can then be placed over the needle mating tip 680 and / or connector interlock 682. The needle assembly 700 is aligned with the needle mating tip 680 so that the orifices are aligned. The needle assembly 700 fits snugly over the connector interlock 682 and the needle mating tip 680 fits snug against the back of the needle. This aligns the needle 704 with the nose of the needle mating tip 680, so that the rear end 705 of the needle 704 is seated in the hole 685 at the nose of the needle mating tip 680. The guidewire 603 can then be extended through the housing 602 and into the rear end of the needle mating tip 680. After the needle assembly 700 is in place, the wire 603 can then be extended through the catheter 702 by operation of the w heel assembly 610.

[0060] The user then places the needle 704 into the patient, such as the vein or artery lumen. Once the needle 704 is placed, the user rotates the guide wheel assembly 610 in the insertion direction Y (FIG. 2). This can be done using a single hand of the user. Since the needle is already positioned in the vein, the user rotates the wheel 610, which is easy to reach because it is at the front end of the housing 602. Thus, the user can hold the rear end housing 606 in the palm of the hand and (without moving their hand) operate the w heel assembly 610 with a single finger (such as the index finger). In addition, the user holds the system 600 steady (e.g.. the housing 602 remains stationary while the user rotates the wheel assembly 610) and facilitates the movement of the wheel 610 to advance the guidewire 603, enabling single- handed operation. Single-handed operation is further facilitated by the contour shape of the hub. Thus, the user can hold another instrument (e.g.. an ultrasound probe) in the other handto assist placement of the guidewire 603 and catheter.

[0061] That action by the user causes the wheel 610 to rotate in direction Y with respect to the housing 602, which in turn moves the drive wheel 616 by operation of the guide wheel teeth 612 and the drive wheel teeth 618. The gasket 619 on the outer surface of the drive wheel 616 forces the guidewire 603 forward, through the housing 602 and into the patient.

[0062] Once the guidewire 603 has entered the user’s vein (e.g., about 1-2.5 inches depending on catheter length), the user pushes the hub 706 forward to force the catheter 702 off the needle 704 and into the patient. The catheter can be pushed into the patient further than the needle and / or guidewire 603 since it is more flexible and won’t puncture the side of the vein or vessel. The user can then remove the needle 704 and guidewire 603 from the patient, leaving the catheter 702 and hub 706 properly placed in the patient. The user can then connect a syringe, IV device or other medical instrument at the rear end of the hub 706.

[0063] It is noted that the system 600 is described as having a guide wheel assembly 610 and a separate drive wheel 616. In some embodiments, the guide wheel 610 can contact the guidewire 603 and move the guidewire 603 forward. For instance, the outer circumference of the wheel 61 1 can be coated with rubber or the like that directly contacts the guidewire 603 to move the guidewire 603 forward. In some embodiments, the outer circumference of the spacing plate 613 can be coated with rubber or have a rubber materials, and that surface can directly contact the guidewire 603 to move the guidewire forward.

[0064] Referring to FIGS. 6-10, the actuator 670 is configured to translationally engage and disengage with a distal end 673 of the sheath 601. The actuator 670 can be (or include) a button, a switch, a lever, a slider, a handle, a tab, a hook, a wheel, a touch screen interface, combinations thereof, or other actuators. For example, the actuator 670 can be a spring-biased button that is biased (e.g., by a spring 674) into an engaged position where the actuator 670 is engaged with a distal end of the sheath 601 (see, e.g., FIG. 8). In some embodiments, theactuator 670 can interface with a finger of the user (e.g., a thumb, an index finger, or another finger) where the user can press and hold down the actuator 670 against a spring-bias.Responsive to the release of pressure by the user, the actuator 670 can return to the biased position (e.g., the engaged position). In another example, the actuator 670 can be a switch that a user toggles between an engaged position and an unengaged position. In another example, the actuator 670 can be a wheel that the user rotates between an engaged and an unengaged position. Other example actuators 670 can be implemented, where the actuator 670 controls engagement and disengagement of the sheath and / or guidewire.

[0065] In some embodiments, the actuator 670 includes or is connected to a sheath retainer 672. The sheath retainer 672 can be operably connected to the actuator 670 such that movement at the actuator 670 translates to movement at the sheath retainer 672. The actuator 670 is configured to extend outwardly from the housing 602, and the sheath retainer 672 is within the housing 602. The sheath retainer 672 includes a frame that connects to the actuator 670, an actuator key 675, and a spring arm 676 that extends from the frame to contact and engage with the spring 674.

[0066] In some embodiments, the actuator key 675 is configured to engage with a notch 677 in the distal end 673 of the sheath 601. For example, the actuator key 675 can extend from the frame of the sheath retainer 672 and extend around the distal end 673 of the sheath 601. A low er portion of the actuator key 675 includes tabs 679 on respective sides of the actuator key 675 that extend radially inward towards each other to define a narrow ed region that interfaced with the notch 677 of the sheath 601. The tabs 679 on respective sides of the actuator key 675 are configured to restrict translational movement of the sheath 601. For example, while the sheath 601 is positioned in the sheath retainer 672, the tabs 679 extend around the notch 677 and restrict or prevent translational movement of the sheath 601.

[0067] An upper portion of the actuator key 675 defines an actuator channel 678 that definesa wider opening than the opening between the tabs 679. The actuator channel 678 is configured to receive the sheath 601 (e.g., the full diameter of the sheath 601) and permit movement of the sheath 601 when the sheath 601 is aligned with the actuator channel 678 (see e.g., FIGS, and 10).

[0068] FIGS. 8-10 illustrate an example sequence of the actuator 670 moving between a first position in FIG. 8 (e.g., engaged position) to a second position in FIGS. 9 and 10 (e.g., disengaged position). In the example sequence, the sheath 601 is removed from the housing 602.

[0069] FIG. 8 illustrates the actuator 607 extended from the housing 602 in an engaged position. This first position is a biased position that the spring 674 exerts pressure on the spring arm 676 to hold the sheath retainer 672 in position engaged with the notch 677. For example, if a user exerted forces on the sheath 601 (e.g., pulled on the sheath 601), the notch 677 would engage with the tabs 679 and the sheath retainer 672 would restrict movement of the sheath 601. In some instances, this engagement of the tabs 679 with the notch 677 prevents removal of the sheath 601.

[0070] FIG. 9 illustrates the actuator 607 engaged into or flush with the housing 602 in a second or disengaged position. In some embodiments, a user can engage with the actuator 607 and apply a force that overcomes the bias of the spring 674. While the user continues to maintain the force at the actuator 670, the sheath retainer 672 is actuated such that the tabs 679 extend beyond the notch 677 and disengage from the sheath 601. In this position, the sheath 601 is positioned within the actuator channel 678, which facilitates translation of the sheath 601.

[0071] FIG. 10 illustrates the actuator 607 engaged in the same position as FIG. 9. with the sheath 601 removed from the sheath retainer 672. In the disengaged position, the sheath 601 can translate out of the actuator channel 678 (e.g.. when a user exerts a force on the sheath601 to remove the sheath 601). The tabs 679 are actuated beyond the sheath 601 and are disengaged from restraining the movement of the sheath 601 in the disengaged position. The actuator 670 is biased into the engaged position via the spring 674, and when the user releases the force at the actuator 670, the actuator returns to the first position shown in FIG. 8.

[0072] FIGS. 11 and 12 illustrate a pin assembly 720 that interfaces with the sheath 601 and guidewire 603. The pin assembly 720 can be connected to the housing 602, and can include a pin 721, a pin arm 722, a spring 723, and a shaft 724. The pin assembly 720 controls the position of the pin 721 in relation to the drive wheel 616 and guidewire 603. In some aspects, the pin 721 is configured to move within a pin channel 725, as controlled by the pin assembly 720.

[0073] The pin 721 can be configured to engage and disengage contact between the guide wire 603 and the drive wheel 616. In some embodiments, the shaft 724 is configured to engage with a distal end of the sheath 601 (e g., as in FIG. 8 and FIG. 11 where the sheath 601 is present). In some embodiments, the pin 721 is configured to rotate within the pin channel 725. For example, while engaged with the drive wheel 616, the pin 721 can rotate along with the drive wheel to facilitate translation of the guidewire 603. In some embodiments, the pin 721 is fixed and restricted from rotational movement. In such examples, engagement of the pin 721 with the drive wheel 616 and the guidewire 603 locks the guidewire 603 in position.

[0074] The distal end of the sheath 601 compresses the shaft 724 against the spring 723 and actuates the pin arm 722 and the pin 721 into a first (e.g., engaged) position shown in FIG.11. The shaft 724 can be an actuator, a switch, a lever, a slider, a handle, a tab. a hook, a wheel, or combinations thereof. The shaft 724 translates compressive forces from the sheath 601 to the pin assembly 720. In the first position, the pin 721 is proximate to the drive wheel616 and can facilitate engagement between the drive wheel 616 and the guidewire 603. With the actuator 670 in the first (e.g.. engaged) position shown in FIGS. 8 and 11, the sheath 601 is restricted from removal from the housing 602, the sheath 601 applies compressive forces at the pin assembly 720, and the drive wheel 616 is engaged with the guidewire 603.

[0075] In some embodiments, the distal end of the sheath 601 can be removed (e.g., as in FIGS. 10 and 12). With the sheath 601 removed, the compressive forces at the shaft 724 against the spring 723 are removed. The spring 723 is biased such that the pin assembly 720 actuates away from the drive wheel 616 when the compressive forces are removed. The second (disengaged) position illustrated in FIG. 12 shows the pin 721 further from the drive wheel 616. In this position, the engagement between the guidewire 603 and the drive wheel 616 is removed. In the second (disengaged) position shown in FIGS. 9, 10, and 12, the sheath 601 is configured to be removed, the compressive forces from the sheath 601 at the pin assembly 720 are configured to be removed, and the drive wheel 616 is configured to be disengaged from the guidewire 603. In some embodiments, disengagement of the drive wheel 616 and the guidewire 603 restricts, limits, or prevents advancement of the guidewire 603 by the drive wheel 616. In some embodiments, disengagement of the drive wheel 616 and the guidewire 603 permits removal the guidewire 603 from the patient and the wire introduction system 600.

[0076] In some embodiments, the pin 721 can be engaged and disengaged from the drive wheel 616 independent of the sheath 601. For example, the pin assembly 720 can be connected to the actuator 670. Movement of the actuator 670 between the first position and the second position can control the engagement and disengagement of the pin 721.

[0077] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of the disclosed technology or of what may be claimed, but rather as descriptions of features that may be specific to particular embodimentsof particular disclosed technologies. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment in part or in whole. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described herein as acting in certain combinations and / or initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.Similarly, while operations may be described in a particular order, this should not be understood as requiring that such operations be performed in the particular order or in sequential order, or that all operations be performed, to achieve desirable results. Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims.

[0078] Accordingly, other implementations are within the scope of the following claims.

Claims

AMENDED CLAIMS received by the International Bureau on 30December 2025 (30.12.2025)1. A wire introduction system for introducing a guidewire into a body of a patient, the system comprising: a housing body including a rear opening; a sheath configured to extend through the rear opening and over the guidewire to connect to the housing body; an actuator coupled with the housing and configured to translationally engage and disengage with a distal end of the sheath, wherein in an engaged position, the actuator facilitates removal of the sheath from the rear end opening, and wherein, in an unengaged position, the actuator restricts removal of the sheath from the rear housing opening; and a pin assembly connected to the housing body and including a pin configured to engage and disengage contact with the guidewire.. wherein the sheath is configured to apply compression forces to the pin to engage contact between the guidewire and a drive wheel; wherein, with the actuator in a disengaged position, the sheath is restricted from removal, the sheath applies compressive forces at the pin assembly, and the drive wheel is engaged with the guidewire.

2. (Cancelled)3. The wire introduction system of claim 1, wherein, responsive to removal of the sheath, the compressive forces are removed from the pin and the pin disengages contact between the guidewire and drive wheel.

4. The wire introduction system of claim 3, wherein the pin assembly is spring- loaded such that, responsive to compressive forces at a pin arm from the distal end of the sheath, the pin arm actuates the pin to engage contact between the guidewire and the drive wheel.

5. The wire introduction system of claim 3 or claim 4, wherein the pin assembly is spring-loaded such that, responsive to a removal of compressive forces at a pin arm from the distal end of the sheath, the pin arm actuates the pin to disengage contact between the guidewire and the drive wheel.

6. The wire introduction system of claim 5, wherein disengagement of the drive wheel and the guidewire prevents advancement of the guidewire by the drive wheel.

7. The wire introduction system of claim 5 or claim 6, wherein disengagement of the drive wheel and the guide wire permits removal the guidewire from the patient and the wire introduction system.

8. The wire introduction system of any one of claims 5 to 7, wherein, with the actuator in an engaged position, the sheath is configured to be removed, the compressive forces from the sheath at the pin assembly are configured to be removed, and the drive wheel is configured to be disengaged from the guidewire.

9. (Cancelled)10. The wire introduction system of any one of claims 2 to 8, wherein the actuator comprises an actuator key that is configured to engage with a notch in the distal end of the sheath.

11. The wire introduction system of claim 10, wherein in the engaged position, the actuator key is engaged with the notch.

12. The wire introduction system of claims 10 or 11, wherein in the disengaged position, the actuator key is translated past and disengaged with the notch.

13. The wire introduction system of any one of claims 10 to 12, wherein the actuator comprises an actuator channel, the sheath is configured to extend through the actuator channel in both the engaged and disengaged positions.

14. The wire introduction system of claim 1, wherein the actuator is spring- biased into the disengaged position.

15. The wire introduction system of claim 1, further comprising one or more guides positioned inside the housing body to guide and support the guidewire.

16. The wire introduction system of claim 1, further comprising a front opening at a front end of the housing body, wherein the guidewire extends through the front opening and the rear opening.

17. The wire introduction system of claim 1, wherein the housing body has a front end portion projecting forward from the housing and configured to receive aneedle having a central opening, wherein the guidewire extends through the central opening of the needle.

18. The wire introduction system of claim 1, wherein the system is configured for single-handed operation, whereby a user can hold the system in a single hand and operate the a drive wheel with an index finger of the hand.

19. The wire introduction system of claim 1, further comprising: a guide wheel rotatably coupled with the housing body; a drive wheel rotatably coupled with the housing and rotatably engaged with the guide wheel, the drive wheel coupled with the guidewire and configured to advance the guide wire into the patient body upon rotation of said guide wheel.

20. The wire introduction system of claim 1, wherein the guide wheel has teeth and the drive wheel has teeth, wherein the guide wheel teeth are engaged with the drive wheel teeth.

21. A sheath removal method comprising: receiving a sheath within a housing body at a sheath retainer; restraining the sheath from translational motion with an actuator in a first position; moving the actuator from a first position to a second position; and releasing the sheath from the sheath retainer with the actuator in the second position. wherein the actuator extends between the sheath and a pin in the housing body such that removal of the actuator from the housing body facilitates the actuator moving from the first position to the second position to move the pin from the first pin location to the second pin location.

22. The sheath removal method of claim 21, further comprising: extending a guidewire through a housing body.

23. The sheath removal method of claim 21 or claim 22, wherein the actuator is biased into the first position.

24. The sheath removal method of any one of claims 21 to 23, further comprising compressing the pin into engagement with a guidewire and a drive wheel.

25. (Cancelled)26. (Cancelled)27. A guidewire introduction system for introducing a guidewire into a body of a patient, the system comprising: a housing body; a sheath retainer; an actuator operably connected to the housing body and to the sheath retainer, wherein the actuator is configured to move between a first position and a second position, wherein the sheath retainer is configured to retain a sheath in the first position and wherein the sheath retainer is configured to release the sheath in the second position; and a sheath, wherein the actuator extends between the sheath and a pin in the housing body such that removal of the actuator from the housing body facilitates the actuator moving from the first position to the second position to move the pin from a first pin location to the second pin location.

28. The guidewire introduction system of claim 27, wherein the actuator comprises a button, a switch, a slider, or a lever.

29. A guidewire introduction system for introducing a guidewire into a body of a patient, the system comprising: a housing body; a wheel positioned in the housing body; a pin positioned in the housing body; an actuator operably connected to the housing body and to the pin, wherein the actuator is configured to move between a first position and a second position to move the pin from a first pin location proximate the wheel in the first position to a second pin location further from the wheel in the second position; and a sheath, wherein the actuator extends between the sheath and the pin such that removal of the actuator from the housing body facilitates the actuator moving from the first position to the second position to move the pin from the first pin location to the second pin location.

30. The guidewire introduction system of claim 29, wherein the actuator comprises an arm extending from the pin to an arm location proximate a receptacle configured to receive a sheath.

31. (Cancelled)32. A guidewire introduction system for introducing a guidewire into a body of a patient, the system comprising: a housing body defining a guidewire path; an actuator operably connected to the housing body, a sheath retainer, and a pin, wherein the actuator is configured to move between a first position and a second position, wherein the sheath retainer is configured to retain the sheath in the first position and wherein the sheath retainer is configured to release the sheath in the second position, wherein the pin is configured to move from a first pin location proximate the wheel in the first position to a second pin location further from the wheel in the second position; and a sheath, wherein the actuator extends between the sheath and the pin such that removal of the actuator from the housing body facilitates the actuator moving from the first position to the second position to move the pin from the first pin location to the second pin location.

33. (Cancelled)34. (Cancelled)35. (Cancelled)36. (Cancelled)This page intentionally left blank.IN THE INTERNATIONAL BUREAU OF WIPOInternational Application No.: PCT / US2025 / 038864International Filing Date: 23 July 2025Applicant: Sonostik LLCTitle: WIRE AND CATHETER PLACEMENT DEVICEVIA ePCTInternational Bureau of WIPO 34, chemin des Colombettes 1211 Geneva 20SwitzerlandDear Sir / Madam:In response to the International Search Report and Written Opinion mailed on 30October 2025, please amend the claims as follows:Claim 1 is amended.Claim 2 is cancelled.Claim 3 is amended.Claims 4-8 are unchanged.Claim 9 is cancelled.Claim 10 is amended.Claims 11-13 are unchanged.Claims 14-21 are amended.Claims 22-23 are unchangedClaim 24 is amended.Claims 25-26 are cancelled.Claim 27 is amended.Claim 28 is unchnaged.Claim 29 is amended.Claim 30 is unchanged.Claim 31 is cancelled.Claim 32 is amended.Claims 33-36 are cancelled.Applicants make amendments to the claims which add no new matter and are enclosed by way of an Article 19 Amendment, which includes Substitute Sheets 24-29.Claim 1 is amended to include the subject matter of original claims 2 and 9.Claim 2 is cancelled.Claim 3 is amended to depend from claim 1 instead of now canceled claim 2.Claims 4-8 are unchanged.Claim 9 is cancelled.Claim 10 is amended to depend from any one of claims 2 to 8 in view of the cancellation of claim 9.Claims 11-13 are unchanged.Claims 14-21 are amended to depend from claim 1 instead of including multiple dependencies.Claims 22-23 are unchangedClaim 24 is amended to include subject matter from original claim 31.Claims 25-26 are cancelled.Claim 27 is amended to include subject matter from original claim 31.Claim 28 is unchnaged.Claim 29 is amended to include subject matter from original claim 31.Claim 30 is unchanged.Claim 31 is cancelled.Claim 32 is amended is amended to include subject matter from original claim 31.Claims 33-36 are cancelled.REMARKSThe Article 19 Amendments are being timely filed within 2 months from the mailing date of the International Search Report and Written Opinion of the International Searching Authority. Original claims 4-8, 11-13, 22-23, 28, and 30 are unchanged, claims 1, 3, 10, 14-21, 24, 27, 29, and 32 are amended, and claims 2, 9, 25-26, 31, and 33-36 are cancelled. Replacement pages 24-29 are attached.Please apply any charges or credits to Deposit Account No. 22980. If any further information is required, please do not hesitate to contact me.Respectfully submitted,Date: December 30, 2025 / Vincent E. Beacom / Vincent E. Beacom, Reg. No. 76,667 Agent for ApplicantFish & Richardson P C.P.O. Box 1022Minneapolis, MN 55440-1022Telephone: +1 (612) 766-2081Facsimile: (877) 769-7945Email: apsii@fr.com

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