CN116916996A - Wire and catheter placement device - Google Patents

Abstract

A device 10 for interfacing with a syringe body 14 and plunger 20 to deliver a wire 24 into a tissue working space 84 includes a needle 32 configured to couple with the syringe body 14 and having an aperture 33 for guiding a proximal end of the wire into the working space 84. The housing 12 is configured to couple with the syringe body 14 for engagement by a user. The slider 18 is configured to couple with the syringe plunger 20 and is engageable by a user to move the syringe plunger between the forward and retracted positions. The slider 18 is releasably coupled to the distal end 28 of the wire to move the distal end of the wire and advance the proximal end 26 of the wire forward in the needle 32 as the slider 18 moves the plunger 20 from the forward position to the retracted position.

Description

Wire and catheter placement device

Cross Reference to Related Applications

The present application claims the benefit of U.S. provisional patent application Ser. No. 63/125,913 (pending) filed on 12/15/2020 and U.S. provisional patent application Ser. No. 63/215,493 (pending) filed on 27/2021, 6, both of which are incorporated herein by reference in their entireties.

Technical Field

The present application relates to a device for positioning a guidewire into tissue and in particular into a working space (e.g. vasculature) in tissue to position other elements for performing a medical procedure.

Background

Commonly found in medicine and surgery, it is necessary to position elements such as catheters and other elements into a working space within tissue, such as the vasculature. Percutaneous puncture (Seidinger) techniques are commonly used for such positioning of guidewires. Typically, in such techniques, a needle is inserted into a vein, artery, or other body cavity or working space. Typically, a syringe is attached to the needle and as the needle is advanced into the skin and tissue, the user pulls back the syringe to create a negative pressure. As the needle passes through the skin and subcutaneous tissue, the lumen or bore of the needle is blocked and the user can only pull the plunger back a small distance due to the vacuum and the negative pressure created within the syringe. Once the needle tip or aperture has entered the target space, e.g., inside a blood vessel, the syringe is filled with blood, air, or other fluid under negative pressure. The user inserting the needle can see this and thus know that the needle has been placed correctly.

Once the needle tip is in the target space, the syringe is removed from the needle. From there, the flexible wire passes through the needle into the target space. The needle may then be slid back and removed from the wire. The dilator is a solid piece of plastic that is passed through the wire into the tissue and working space and then removed. A catheter, typically the same size as the dilator but more flexible, may then be placed into the target space over the wire, which is guided by the wire.

One of the current drawbacks of the prior art is that several problems may occur at various stages from removing the syringe from the needle to feeding the wire into the needle and into the working space. Moving and manipulating the wire may be awkward and difficult for the user. The wire is thin and often shakes. Thus, if a portion of the wire encounters an object outside of the sterile field, the wire may become non-sterile. It can also be difficult to place the wire into the back of the needle. The needle may also be moved when the syringe is removed from the needle and when the user stretches the wire and penetrates it into the needle. In this case, the needle may be pulled out of the target space, thereby causing the wire to be unable to advance. The needle may also be advanced farther than desired. This may lead to complications. For example, in the case of jugular intravenous central venous catheter placement, the carotid artery is typically located posteriorly. If the penetration depth of the needle into the vein is beyond what is expected, the needle tip may enter the artery without the user's knowledge. The wire enters the artery. The artery may then dilate. This can lead to serious complications given the just larger holes in the high pressure arterial system.

Accordingly, there is a need for devices and methods that can improve the safety and time efficiency in percutaneous techniques and similar techniques for positioning wires in a body working space. There is also a need for improved ergonomics and to allow the user to more easily aspirate negative pressure and receive feedback during wire placement.

Disclosure of Invention

A device for interfacing with a syringe body and a plunger to deliver a wire into a tissue working space includes a needle configured to couple with the syringe body and having at least one aperture for guiding a proximal end of the wire into the working space. The housing is configured to couple with the syringe body and includes a portion, such as one or more grip portions, for engagement by a user. The slider is configured for coupling with a syringe plunger to move the syringe plunger between a forward position and a retracted position. The slider also includes a portion for engagement by a user for movement thereof. The user may grasp the housing and the slider to engage and manipulate the syringe. The slider is releasably coupled with the distal end of the wire to move the distal end and advance the proximal end of the wire forward in the needle as the slider moves the syringe plunger from the forward position to the retracted position. For example, the slider may include a wire gripping structure for releasably gripping the distal end of the wire to move the distal end of the wire when the syringe plunger is moved. To advance the proximal end of the wire in the needle when the slider moves the syringe plunger to the retracted position, one embodiment includes a wire advancement mechanism for translating movement of the distal end of the wire to advance the proximal end of the wire as the syringe plunger moves to the retracted position.

Drawings

Fig. 1 is a perspective view of a wire and catheter placement device according to an embodiment of the present invention.

Fig. 1A is an exploded perspective view of a wire and catheter placement device according to an embodiment of the present invention.

Fig. 2A is a side view of the wire and catheter placement device of fig. 1 in a forward position according to an embodiment of the present invention.

Fig. 2B is a side view of the wire and catheter placement device of fig. 1 in a retracted position in accordance with an embodiment of the present invention.

Fig. 3A is a top view of the wire and catheter placement device of fig. 1 in a forward position according to an embodiment of the present invention.

Fig. 3B is a top view of the wire and catheter placement device of fig. 1 in a retracted position according to an embodiment of the invention.

Fig. 4A is a side view of the wire and catheter placement device of fig. 1 in a forward position for inserting the wire into tissue in accordance with an embodiment of the present invention.

Fig. 4B is a side view of the wire and catheter placement device of fig. 1 in a retracted position to insert the wire into a working space in tissue in accordance with an embodiment of the present invention.

Fig. 4C is a side view of the wire and catheter placement device of fig. 1 showing a catheter arrangement for insertion into a working space in tissue via the wire.

Fig. 4D is a side view showing a catheter arrangement for a working space inserted into tissue via an inserted wire, according to an embodiment of the invention.

Fig. 4E is a side view illustrating a catheter arrangement for insertion into a working space in tissue via an inserted wire, according to an embodiment of the invention.

Fig. 4F is a side view illustrating a catheter for insertion into a working space in tissue via an inserted wire, according to an embodiment of the invention.

Fig. 5 is a perspective view of a wire and catheter placement device according to another embodiment of the present invention.

Fig. 6A is a side view of the wire and catheter placement device of fig. 5 in a forward position with the wire and catheter arrangement placed in the device.

Fig. 6B is a side view of the wire and catheter placement device of fig. 5 in a forward position with the wire and catheter arrangement in the device.

Fig. 6C is a side view of the wire and catheter placement device of fig. 5 moved to a retracted position to advance the wire for placement of a catheter arrangement.

Fig. 6D is a side view of the wire and catheter placement device of fig. 5 in a retracted position with the advanced wire used to place the catheter arrangement.

Fig. 6E is a top view, partially in cross-section, of the wire and catheter placement device of fig. 5 in a retracted position with the advanced wire used to place the catheter arrangement.

Fig. 6F is a top view, partially in cross-section, of the wire and catheter arrangement of fig. 6E, with the wire and catheter placement device of fig. 5 largely removed.

Fig. 6G is a top view, partially in cross-section, of the wire and catheter arrangement of fig. 6F to be inserted into a working space in tissue via an inserted wire in accordance with an embodiment of the present invention.

Fig. 6H is a top view, partially in cross-section, of the wire and catheter arrangement of fig. 6G to be inserted into a working space in tissue with the needle removed.

Fig. 6I is a top view, partially in cross-section, of the wire and catheter arrangement of fig. 6G inserted into a working space in tissue.

Fig. 6J is a top view, partially in cross-section, of the wire and catheter arrangement of fig. 6I having been inserted into a working space in tissue, with the dilator removed.

Fig. 7 is a perspective view of a wire and catheter placement device according to another embodiment of the present invention.

Fig. 8A is a top view of the wire and catheter placement device of fig. 7 in a forward position according to an embodiment of the present invention.

Fig. 8B is a top view of the wire and catheter placement device of fig. 7 in a retracted position in accordance with an embodiment of the present invention.

Fig. 9 is a perspective view of a wire and catheter placement device according to another embodiment of the present invention.

Fig. 10 is a side view of the wire and catheter placement device in a forward position.

FIG. 11 is a perspective view of an alternative needle for the wire and catheter placement device of an embodiment of the present invention.

Fig. 12 is another perspective view of the alternative needle of fig. 11.

Fig. 13 is a top view of the alternative needle of fig. 11.

Fig. 14 is a top view of an alternative device of the present invention.

Detailed Description

Fig. 1 illustrates an embodiment of a device 10 for advancing a wire into a body space or working space, such as the vasculature of an animal (e.g., human). Such wire advancement may be used in many different medical procedures and is commonly referred to as percutaneous puncture techniques. The term vasculature is generally used herein to refer generally to space or working space in tissue within the body, but the use of the present invention is not limited to just wire placement in the vasculature. Furthermore, while the embodiments discussed are for placement of a guidewire to position other elements in a body working space, the device may insert other wire structures, and thus the elements are referred to herein as "wires.

The device 10 includes a housing 12 that includes or is configured to be coupled to a syringe body 14. The housing defines portions for engagement by a user, such as one or more grip portions 16. The housing provides a way to hold the syringe body. A slide element or slide 18 is positioned along the exterior of the housing and is configured for coupling with a syringe plunger 20. For example, the syringe plunger 20 moves inside the syringe body 14 between a forward position as shown in fig. 2A and a retracted position as shown in fig. 2B. The slider 18 also includes a grip portion 22 for engagement by a user to move the slider 18 and syringe plunger 20 relative to the housing 12 and syringe body 14. The slide serves as an extension of the plunger. In particular, the slider 18 provides a way for the user to more easily engage the syringe plunger 20 and move it from the forward position to the retracted position during use of the device 10.

The device 10 maneuvers and includes a wire 24 for delivery and placement into a tissue working space. The wire 24 includes a proximal end 26 and a distal end 28. The slider is releasably coupled to the distal end of the wire for moving the distal end to advance the proximal end forward in the needle when the slider moves the plunger from the forward to the retracted position. The slider 18 in one embodiment as shown in fig. 1 includes a wire gripping structure 30 that releasably engages or grips the distal end 28 of the wire to facilitate movement of the wire with the plunger, as described herein. In accordance with a feature of the present invention, the needle 32 is coupled with the syringe body 14 and is also configured with an aperture for guiding the proximal end 26 of the wire into the vasculature or another working space. More specifically, rearward movement of the slider 18 and the coupled syringe plunger 20 to a retracted position away from the needle 32 in the syringe body will draw negative pressure in the needle. Movement of the slider 18 releasably holding the wire will also attempt to advance the wire 24 through the needle 32 into the vasculature. To this end, as shown in FIG. 1, a wire advancing mechanism 34 is generally coupled between the slider 18 and the housing 12. The wire advancing mechanism 34 acts on the wire to translate movement in one direction into movement in the other direction. The mechanism 34 is configured to translate movement of the distal end of the wire into movement for advancing the proximal end 26 of the wire into and through the needle 32 as the slider 18 moves the syringe plunger 20 from the forward position to the rearward or retracted position as shown in fig. 2B.

The purpose of the wire advancing mechanism is to reverse or translate the rearward movement of the slider 18 and the concomitant movement of the syringe plunger 20 to the retracted position and to produce, in one movement stroke, movement of the proximal end of the wire 24 forward into and through the needle. As shown in fig. 2A and 2B, a human operator's hand 40 engages the gripping portions 16 and 22 of the housing 12 and slider 18, respectively, and moves the slider along the housing to a retracted position, as shown in fig. 2A and 2B. The wire gripping structure 30 of the slider 18 in fig. 1 releasably grips the distal end 28 of the wire, thereby coupling the slider and wire together. Movement of the slider 18 and syringe plunger 20 to the retracted position causes the distal end of the wire to move toward the wire advancing mechanism 34. The wire advancement mechanism 34 reverses or translates the rearward movement of the wire distal end into a forward or advancement movement of the wire proximal end 26 into and through the needle 32. As the slider 18 and plunger 20 are moved further to the retracted position, the proximal end 26 of the wire is advanced further through the needle and eventually into the vasculature or another working space into which the needle is inserted.

Thus, the device 10 of the present invention provides a single movement of the wire through the needle 32 and into the vasculature and a unique and smooth forward movement as the plunger is moved to the retracted position and negative pressure is drawn and released relative to the syringe plunger 20 moved by the slide 18. The slider 18 is coupled to both the wire and the plunger and moves both the syringe plunger 20 and the wire 24 in a single stroke or motion of the slider 18, as further described herein.

The needle 32 is configured for coupling with a syringe body and has at least one base or lumen for guiding the proximal end of a wire. The device 10 further includes a hub 50 for coupling the needle 32 with the device. Needle hub 50 couples needle 32 with syringe body 14 and wire 24. Fig. 3A and 3B show a cross-sectional top view of the device with the slider and syringe plunger in a forward position and then the slider and syringe plunger in a retracted position for advancing the wire 24. Needle hub 50 includes a guide channel 52 coupled with needle bore 33 for guiding movement of wire 24 into and through needle 32. The needle hub 50 also includes a vacuum channel 54 coupled with the syringe body 14 to create a negative pressure in the needle bore when the syringe plunger is moved to the retracted position shown in fig. 3B. As described herein, movement of the slider and syringe plunger to the retracted position shown in fig. 3B will aspirate negative pressure within needle 32 through needle hub 50. The negative pressure will generally prevent significant rearward movement of the slider and syringe plunger to the retracted position under the force of the gripping hand on the gripping portions 16 and 22 of the housing and slider, respectively, as long as the needle is blocked by tissue. The slide and plunger may be moved slightly to create negative pressure with hand pressure but will be prevented from moving easily to the fully retracted position. Once the needle tip pierces the tissue and vasculature and the negative pressure is broken, the slider and syringe plunger can be more easily aspirated or moved to a retracted position in the device 10. At the same time, movement of the slide and plunger also moves the wire gripping structure 30 rearward relative to the needle 32. This pushes the wire 24 through the wire advancement mechanism 34 and turns or reverses or translates the wire movement and then advances the proximal end 26 of the wire through the needle 32, as shown in fig. 3B.

In the embodiment of the invention shown in fig. 1-3B, hub 50 creates an airtight passageway in both vacuum passageway 54 and guide passageway 52. Needle 32 is hollow and includes a bore 33 sized to allow wire 24 to pass therethrough. The holes 33 are also sized to allow air and/or fluid to pass through the needle 32 simultaneously as the wire 24 moves within the needle. The needle hub 50 forms a vacuum channel 54, the needle bore 33, and the intersection 60 of the guide channel 52 of the wire 24. The syringe body 14 forms an airtight seal with the needle hub 50 and the passageway 54. In one embodiment of the invention shown in the drawings, the syringe body 14 includes a tip 15 that fits into a suitably formed opening or cavity 17 in the hub. The vacuum channel 54 provides a connection between the needle 32 and the interior space 19 of the syringe body through engagement with the intersection section 60 and the needle aperture 33, as shown in fig. 3B. When the user pushes the syringe plunger 20 into the retracted position, as indicated by arrow 62, pressure is generated to draw gas or fluid through the needle 32, through the vacuum channel 54 and into the interior space 19 of the syringe body. To ensure that such a negative pressure is created in the needle 32 and in particular in the bore 33 of the needle, the channel 52 of the guide wire 24 in the embodiment of fig. 1 must also be airtight. To this end, the hub includes a sealing mechanism 64 engaged with the guide channel 52 and the wire 24 for providing an airtight seal in the guide channel. That is, as the wire 24 passes through the sealing mechanism and into the guide channel 52, the sealing mechanism 64 engages the wire, thereby maintaining the negative pressure and the wire 24 may simultaneously move through the guide channel of the needle hub and through the needle 32 while the negative pressure is being extracted by the movement of the plunger 20 within the syringe body 14. In one embodiment, the sealing mechanism 64 may require a rubber or silicone element with holes for passing through the wire. The wire 24 may be a smooth wire or a coiled wire. The coiled wire may have a coating thereon, or may have a substance applied as a coating material, such as petrolatum.

In the present invention, the needle hub 50 is shown separating the fluid/air passage of the syringe from the wire passage. This allows the syringe to be removed while the guidewire is still in the needle and a Fabian test to be performed when the guidewire has been positioned or advanced. This can verify if the guidewire is in an artery rather than the intended vein.

Hub 50 has a syringe passageway adjacent to but not in line with the needle. Instead, the guide channel is aligned with the needle to move the wire straight into the needle. This reduces friction and provides easier propulsion. In another embodiment, as shown in fig. 14, the syringe or vacuum channel is aligned and the wire enters at an angle. The preformed needle may be used in a needle mount. Alternatively, the needle may be manufactured directly with the needle base. In one embodiment, the needle mount may be made of a transparent material or include a transparent region to be more easily visible when fluid enters the needle.

As can be appreciated, the syringe plunger 20 may be configured similar to a typical syringe plunger having an elongated body portion that is terminated in a rubber or plastic stopper 21 that seals with the interior wall of the syringe body 14 and creates a gas and fluid seal. The force provided on the end 23 of the syringe plunger 20 in the direction of arrow 62 will move the syringe plunger 20 and stopper 21 to the retracted position, as shown in fig. 3B. Fig. 3A shows the syringe plunger 20 and stopper 21 in a forward position, against the end of the syringe body 14 and adjacent the tip 15. If the needle tip is blocked, a negative pressure is created in the syringe.

According to one aspect of the invention, the housing 12 is configured for coupling with a syringe body. In one embodiment, the syringe body 14 may be formed as a unitary structure with the housing, wherein the syringe body includes an integrally molded housing and grip portion. In another embodiment of the invention, the housing 14 may be configured to house a separate syringe body 14, with the syringe body in place relative to the grip portion 16 of the housing. Similarly, the slider 18 may be formed and configured for coupling with a syringe plunger, or the slider may be formed with the syringe plunger or as a single piece as an extension of the syringe plunger such that the slider and grip portion move as one piece with the syringe plunger. Alternatively, the slider 18 may be formed and configured to couple to a separate syringe plunger so as to couple movement of the slider to the syringe plunger. As such, the housing 12 and the slider 18 may be configured and dimensioned to receive and utilize a typical syringe having a syringe body and a syringe plunger.

To this end, fig. 1A shows an embodiment of the device 10 in which the housing 12 includes a generally cylindrical channel 17 configured to receive the syringe body 14 for coupling with the syringe body. The slider 18 is configured to slide on or adjacent to the housing 12 and is positioned generally parallel to the housing. The guide element 11 on the housing 12 may engage the slider 18 to ensure linear movement of the slider relative to the housing and syringe body to the retracted position. The slider 18 has an end 25 with a recess 29 or other structure for engaging the end 23 of the syringe plunger 20 to retain the end 23 and couple the slider and plunger. The engagement of the plunger and slide may be a friction fit or the plunger end 23 may be retained in the recess by one or more tabs 37 that snap onto the end 23. In this way, the slider acts as an extension of the plunger to move the plunger.

The housing 12, syringe body 14, slider 18 and syringe plunger 20 may be formed of a suitable material, such as a lightweight and sterilizable plastic material. This material provides sufficient rigidity for movement of the plunger in the syringe body and for clamping and guiding of the wire 24.

According to one feature of the invention, the wire advancing mechanism 34 is configured to advance the proximal end of the wire into and through the needle as the slider moves the syringe plunger from the forward position to the retracted position. That is, the wire advancing mechanism 34 is used to turn or redirect the wire such that moving the syringe plunger back to the retracted position away from the needle effectively simultaneously advances the wire into and through the needle and ultimately into the vasculature where the needle pierces, as described herein. This is done in a single fluid motion in which the plunger is moved to the retracted position while advancing the wire into the needle.

Fig. 1-3B illustrate a wire advancing mechanism 34 that includes a loop guide 70 for reversing or converting the direction of wire movement in accordance with an embodiment of the present invention. The ring guide is typically positioned between the slider 18 and the housing 12 so as to provide reversal or translation in the direction of wire movement relative to movement of the slider 18 and syringe plunger. Specifically, referring to fig. 1, wire advancing mechanism 34 includes a loop guide 70 having an input or distal end 72 positioned to receive wire from wire gripping structure 30 of slider 18 and an output or proximal end 74 for guiding the proximal end of wire 24 and outputting the wire into hub 50 and ultimately into needle 32. The ring guide 70 may be a closed tube, as shown in fig. 1. Alternatively, the loop guide may be open and form a suitable structure for capturing and guiding the wire 24 from the distal end 72 to the proximal end 74. As shown in fig. 1, the housing 12 may be suitably formed to include mounting sections 76, 78 that interface with and receive the distal and proximal ends 72, 74, respectively, of the ring guide 70. Depending on the length of the housing and the length of the ring guide 70 and the length of the syringe body, slide and syringe plunger, one or more additional mounting sections 80 may be implemented in the housing 12 to retain a portion of the ring guide 70 between the distal end 72 and the proximal end 74. As shown in fig. 2A, the wire 24 is received by a loop guide 70 that reverses the direction of movement of the wire 24 and the slider 18, as indicated by reference arrow 62, and changes the direction of movement of the proximal end 26 of the wire 24 in the direction of arrow 63. In this way, by rearward movement of the slider 18 and plunger in the direction of arrow 62, a negative pressure or vacuum can be drawn through the syringe body 14 and, at the same time, when pressure is released, the proximal end 26 of the wire will advance in the direction of arrow 63 or in the direction of movement of the needle 26 into the working space, as described herein.

The terms proximal and distal, particularly with respect to the wire 24 and its end or section, as used herein, are used to indicate that one end of the body is approaching, the end traveling through the needle and into the working space, and the other end is disengaged from the needle and held and urged by movement of the slider 18 and plunger. It generally refers to sections or portions of the wire relative to each other, and not specifically to the tip or terminating end of the wire. Thus, the proximal end 26 of the wire 24 refers to the portion or section of the wire that moves into and/or through the needle, while the distal end 28 of the wire refers to the portion or section of the wire that is releasably coupled to and moved by the slider 18 to push the proximal end of the wire into position in the tissue working space.

Figures 4A-4F illustrate other techniques for using the present invention and inventive methods to perform percutaneous puncture techniques or for positioning wires and other elements (e.g., catheters) into the vasculature or some other lumen or working space of a patient. The device 10 is held by the hand 40 of the user to engage the syringe. In particular, the fingers of the hand are positioned at the different gripping portions 16 and 22 of the elements that are coupled to or part of the syringe. Typically, the gripping portion 16 of the housing is held by the user's hand 40 and fingers while the index finger or another finger is positioned adjacent the gripping portion 22 of the slider 18 to move the slider relative to the housing. In this way, the syringe body and plunger engage for movement.

Fig. 4A shows the vasculature of an animal (e.g., human) that includes one or more layers of skin or tissue 82 that bound or define an internal passageway (working space) 84 that carries blood of a patient. The device 10 is held and the needle 32 is positioned against the skin 82 and pushed in the direction of arrow 86 into the skin and subcutaneous tissue reflected by the reference element 82. The tip 33 of the needle 32 and its bore are initially blocked by the skin and subcutaneous tissue 82. As the needle tip becomes occluded, the retractive force of the user's finger on the grip portion 22 in the direction of arrow 62 will move the plunger and create and aspirate a negative pressure within the syringe body 14. Typically, movement of the slider 18 as shown will attempt to move the plunger 20 from the forward position to the retracted position and thus attempt to draw air or fluid into the needle 32. However, since the needle tip 33 is within the subcutaneous tissue or skin 82, no air or fluid may enter the needle 32. Thus, as the user attempts to move the slider 18 and draw in fluid/air, a negative pressure or vacuum is created within the syringe body 14 and, in particular, within the interior space 19 of the syringe body. Typically, the wire 24 is threaded into the needle 32 and may be threaded a distance sufficient to access the tip 33 at the beginning of the procedure. As shown in fig. 4A, the proximal end of the wire may be located just at or behind the tip 33 as the wire passes into the tissue 82. The slide 18 may move slightly in the direction of arrow 62 before the plunger encounters significant resistance from the evacuation within the syringe body 14. Since movement of the plunger 18 and associated wire gripping structure 30 will move the wire 24 slightly, it is generally desirable to position the tip of the wire proximal end 26 or the terminal end of the wire slightly rearward of the needle tip 33 at the beginning of the procedure so that the needle does not come out of the needle upon brief initial aspiration of the plunger and vacuum. This distance may be determined by the size of the syringe body/plunger and may be adjusted by the user as needed by manually moving the wire within the gripping structure 30 so that the device 10 may be customized to the desired amount of negative pressure and slider movement before the distal end of the wire removes the tip of the needle 33. In some embodiments, the wire may be 1-2 cm back from the tip. Space 84, such as a working space within the vasculature defined by tissue 82, is the ultimate target for the tip of needle 33 and wire 24.

Referring to fig. 4B, once needle 32 passes through tissue 82 and into space 84, fluid/air may be aspirated and no negative pressure or vacuum may exist. Thus, the slider 18 and the syringe plunger 20 may be more easily moved in the direction of arrow 62. That is, when the needle tip 33 is in the space 84 and there is no vacuum, the slider and syringe plunger may be further aspirated back into the retracted position, as shown in fig. 4B. With this movement, the distal end 28 of the wire 24 moves toward the wire advancing mechanism 34. That is, for the ring guide 70 embodiment shown in fig. 4A-4F, the wire is moved toward and through the ring guide 70 and the direction is reversed to move the proximal wire end 26 in the direction of the needle, as reflected by arrow 86 shown in fig. 4B. That is, according to one aspect of the present invention, the wire advancing mechanism is configured to translate or reverse the wire motion and advance the proximal end 26 of the wire into and through the needle as the slider 18 moves the syringe plunger 20 from the forward position to the retracted position. It should be appreciated that the retracted position may be any position in the syringe body that is rearward of the foremost position of the evacuation. Thus, the retracted position is typically relative to the forward position, rather than the absolute rearward position of the syringe plunger in the syringe body. The user controls retraction of the slide and plunger. As the distal end 28 of the wire moves rearward with the slider 18, the proximal end of the wire 24 is advanced through the needle 32 and into the target space 84. As described above, although the examples set forth herein discuss movement of a wire into the vasculature, the target space may be any suitable vessel, abscess, or other target of a body cavity or patient, and thus the use of the device 10 is not limited to a particular vasculature, although vasculature is used herein as a term generically representing a target space of a wire within a patient.

Once the wire 24 has been advanced into the target space, the distal end 28 of the wire may be removed from the wire gripping structure 30. To this end, the clamping structure 30 may include a lever arm 31, as shown in FIG. 1, that may be compressed to open the wire clamping structure 30 to release the distal end 20 of the wire 24. Thereafter, the wire 24 is free to be manipulated by the user rather than being coupled to the slider 18 and plunger. Because the wire 24 is already well within the target space 84, small, unintended movements of the wire by the user will not remove it from the target space 84. Referring to fig. 4B, the wire 24 may generally be grasped at an exposed section reflecting the distal end 28 and at the portion of the wire located behind the proximal end 26 near the housing 12. The user can grasp the wire at any exposed position for further manipulation. For example, when the device 10 is held by one hand, the other hand of the user may be used to further advance the wire. Once the wire has advanced a desired distance within the space 84, it may be used to insert other elements into the target space 84. For example, a wire may be used to advance a catheter with a dilator into the space.

Referring to fig. 4C, the device 10 and in particular the needle 32 and hub 50 may be removed from the wire. However, it may be desirable initially to remove only the syringe body and the remainder of the device from the hub and leave the needle in place for additional procedures. For example, the fischer test may be performed by connecting the tubing to an opening in a hub coupled to the vacuum channel 54, or to a channel initially coupled to the syringe body 14. For procedures such as positioning of catheter 100, device 10, including needle 32 and hub 50, is removed and the wire is pulled up, as shown in fig. 4C. Specifically, the device 10 and needle 32, as well as the needle hub 50, may be removed from the wire 24 positioned in the space 84 in the direction of arrow 90. In one use, the wire 24 may be used for the purpose of guiding and positioning a catheter into the target space 84 such that the wire 24 is used for guiding. Referring again to fig. 4C, once the device 10 and needle 32 are removed, the catheter 100 surrounding the dilator 102 will be threaded onto the distal end 28 of the wire.

Referring to fig. 4D, once the wire 24 has been threaded into the dilator 102 and catheter 100, these elements can be slid through the opening in the tissue 82 and the same opening for insertion of the wire. As shown in fig. 4E, dilator 102 and catheter 100 may then be positioned in space 84 for further procedures. The wire 24 and/or dilator 102 may then be removed from the catheter 100 and space 84, as shown in fig. 4F. The wire 24 may be removed first and then the dilator 102 removed, or both may be removed to leave the catheter 100 in place for performing further procedures within the target space 84 (e.g., vasculature).

The device 10 provides significant advantages over techniques for introducing and advancing wires and other elements within a target space of a patient. The device 10 directly couples retraction of the syringe plunger to advancement of the wire 24 through the releasable wire gripping structure 30. The force for moving the slider and plunger is typically the same as the force for moving the wire into the needle and working space. That is, there is no intervening mechanism in the device 10 so that the wire motion haptic feedback is directly to the plunger and slider and the user's finger. Once the needle tip enters any target vessel, abscess, body cavity, or other space, the wire may be advanced. The user can position the wire within the target space with a single hand. The function of the syringe body 14 and the movement of the syringe plunger therein by the slider 18 and the movement of the wire by the ring 70 are the only resistances encountered by the user and thus allow for greater tactile feedback in the process. The direct coupling between the movement of the syringe plunger and the simultaneous advancement of the wire allows the user to better feel how the wire is advanced and provides faster feedback that the wire may not be properly advanced. For example, if the wire is advanced into a vessel wall or occlusion, or if the needle is withdrawn from the target space prior to advancement of the wire, the user is fed back instantaneously via the housing and slider and grip portions 16 and 22 provided on the housing 12 and slider 18. In addition, the wire 24 is advanced outside of the syringe housing 12 or syringe plunger, as shown in fig. 1. This allows other elements to be preloaded onto the wire for placement using the wire in the target space 84, as discussed further herein.

The present device 10 and other alternative embodiments of the present invention described herein may be held in one hand for providing substantially a single motion. In alternative embodiments, a robot may be used for engagement instead of a hand. The same hand or motion that pulls the syringe plunger may be used to advance the wire. The user is controlling the advancement of the wire and no springs, lever intervention, or other mechanism removes the user's control. If the wire encounters resistance felt in the device, the user may stop moving the plunger and advance the wire. Furthermore, an additional advantage is that the device 10 and its associated embodiments allow for the use of longer wires. The wire advancement mechanism 34, and in particular the loop guide 70 or other guide structure, may be configured and sized based on the desired length of wire. Additional wires may then allow the catheter/sheath and dilator to be preloaded onto the wires for introduction through the wires into the target space, as discussed further herein. According to another feature of the present invention, different sized syringe bodies 14 may be used with different amounts of fluid from a target space associated with greater or lesser movement of the wire based on movement of the slide and wire gripping structure 30. That is, if a syringe body 14 and syringe plunger with a larger diameter are used, more air/fluid is required to transition the slider back and move the syringe plunger to a retracted position a distance. Smaller diameter syringe bodies 14 and syringe plungers 20 may be used if it is preferred to pass a smaller amount of air/fluid through the syringe to advance the wire a desired distance. The wire and syringe are decoupled so that the wire can be advanced independently of the fluid suction and the ability to accommodate the fluid suction is useful if the target space is small. This ability to move the wire without too much suction or independent of further suction is advantageous if significant fluid suction can collapse the target space.

In the present invention, access to the target space is determined using a single hand of the user, and the slider 18 and syringe plunger 20 are moved back to the retracted position while the wire is advanced simultaneously and typically in a single stroke. Furthermore, the force for advancing the wire is directly generated by the user and can therefore be applied more sensitively and accurately than other mechanisms such as springs or levers that advance the wire. That is, there is typically a 1:1 force ratio using the device 10 to pull the plunger and advance the wire. This provides very sensitive feedback in the use of the device by the user's hand and the movement of the wire to the user.

The present device 10 and other disclosed embodiments may be used with a range of needle sizes, syringe body sizes, and wire sizes. A tapered wire may be used for the wire element to allow fluid in the needle to pass easily through the wire into the syringe body. In addition, a wire having a wound wire tip with the remainder of the wire smooth may be used. In this way, the seal around the wire may be airtight, but fluid/air may more easily bypass the tip of the wire into the needle. As noted, the housing 12 and the syringe body 14 may be formed such that they are one piece. Similarly, the slider 18 and the syringe plunger 20 may be formed together as a single piece. The syringe plunger and wire gripping structure with the gripping portion will then engage the syringe body with its own gripping portion to provide the desired interaction of the components. Alternatively, the housing 12 and the slider 18 may be configured separately from the syringe assembly. In this case, the syringe body 14 would mate or snap or otherwise couple with the appropriately configured housing 12, while the syringe plunger 20 would mate or snap or otherwise appropriately couple with the slider, with the slider 18 and syringe plunger interacting as disclosed.

The wire gripping structure 30 shown in fig. 1 and 2A may be a clamp type structure having opposed clamp ends 33, 35 biased together to frictionally grip or clamp the wire 24 at its distal end 28. The lever structure 31 shown in fig. 1 can be operated to open and close the clamp ends 33, 35 to clamp or release the wire 24. A pair of clamp ends may be used to releasably clamp the distal end of the wire. The grip should be tight enough to provide the necessary movement of the wire when the slider 18 and plunger are moved to the retracted position under the force of the user's hand. Other wire gripping or wire gripping structures may be used as long as the wire can be released from the plunger/slider motion.

The present invention provides ergonomic advantages and stability that utilize a single hand of a user. For example, a grip portion 16 extending from the housing 12 allows a thumb and one or more middle fingers to grip the device and stabilize the syringe body. The gripping portion 22 positioned at the forward end of the slider 18 allows the index finger of the same hand to easily and comfortably move the plunger and aspirate negative pressure, and then subsequently advance the wire as the needle enters the target space. The thumb and one or more middle fingers can firmly support the device 10 and syringe body, while the index finger can control the movement of the slider, syringe plunger and wire individually. This allows the user to keep the needle tip very stable to prevent removal of the needle from the target space while simultaneously advancing the wire.

Fig. 5 shows an alternative embodiment of a device 110 that is similar to the device 10 but provides for advancing and positioning a wire preloaded with a catheter, dilator, or other element into a target space in tissue, such as into the vasculature of a person. As with other embodiments of the present invention, such wire advancement may be used in a variety of different medical procedures. Similar elements between devices 10 and 110 will share some common reference numbers for common elements. The device 110 includes a housing 112 that includes or is configured to be coupled with the syringe body 14 and the grip portion 16 for engagement by a user. As with device 10, the housing and grip portion may be part of the unitary syringe body or separate from the body. The slider 18 is positioned adjacent the housing 14 and is part of a plunger or is configured to couple with a syringe plunger 20. For example, the syringe plunger 20 moves inside the syringe body 14 between a forward position as shown in fig. 6B and a retracted position as shown in fig. 6C. The slider 18 also includes a grip portion 22 for engagement by a user to move the slider 18 and syringe plunger 20 relative to the housing 112. Specifically, the slider 18 moves the syringe plunger 20 from the forward position to the retracted position during use of the device 10. As described herein, the housing 112 may be sized to receive a catheter arrangement in front of the wire advancing mechanism.

The device 110 also includes a wire 24. The wire 24 includes a proximal end 26 and a distal end 28. The slider 18 also includes a wire gripping structure 30 that releasably grips the distal end 28 of the wire to facilitate movement of the wire, as described herein. In the embodiment of the device 110 shown in fig. 5, the wire 24 is preloaded with other components that are guided by the wire to be inserted into the target space in the tissue. Specifically, as shown in fig. 5, the dilator 102 and catheter 100 (i.e., catheter device) are loaded onto the wire. Catheter 100 may include one or more ports 104 that are fed into the catheter according to the medical procedure for which the catheter is to be used. In accordance with features of the present invention, needle 132 is coupled to syringe body 14 and is also configured for guiding proximal end 26 of the wire into a working space, such as a vasculature space. Similar to the device 10, movement of the slider 18 and syringe plunger 20 rearwardly away from the needle 132 and body will draw negative pressure and will also attempt to advance the wire 24 through the bore of the needle 132 into the vasculature or other target space in a single movement.

To this end, as shown in FIG. 1, a wire advancing mechanism 134 is generally coupled between the slider 18 and the housing 112. The wire advancement mechanism 134 guides the wire and is configured to advance the proximal end 26 of the wire into the needle 132 as the slider 18 moves the syringe plunger 20 from the forward position to the retracted position, as shown in fig. 6C.

The purpose of the wire advancing mechanism is to reverse or shift the rearward movement of the slider 18 to the retracted position and the concomitant movement of the syringe plunger 20 and create a forward movement of the wire 24 into and through the needle 134 in one movement stroke. As described herein, the operator's hand or some other mechanism (e.g., a robot) engages the respective housing and the respective gripping portions 16 and 22 of the slider and moves the slider 18 back along the housing toward the retracted position, as shown in fig. 6B and 6C. The wire gripping structure 30 of the slider 18 grips the distal end 28 of the wire. Movement of the slider 18 and syringe plunger 20 to the retracted position causes the distal end 28 of the wire to move past the wire advancing mechanism 134. The wire advancement mechanism reverses or translates the rearward movement of the wire distal end into forward movement of the wire proximal end 26 into and through the needle 132. With the slider 18 and plunger 20 moved to the retracted position, the proximal end 26 of the wire is simultaneously advanced through the needle and eventually into the target space into which the needle is inserted, as described herein.

In the embodiment shown in fig. 5-6J, the housing 112 is configured to space the wire advancing mechanism 134 further rearward of the housing 112. In accordance with the present invention, wire advancing mechanism 134 operates similarly to mechanism 34 and guides the wire and is configured to advance the proximal end of the wire into and through the needle as the slider moves the syringe plunger from the forward position to the retracted position. The wire advancement mechanism 134 is positioned to allow other elements (e.g., the dilator 102 and catheter 100) to be pre-threaded or pre-positioned onto the wire prior to insertion of the wire into the working space. The housing is configured to secure the catheter arrangement. The catheter is then presented for placement immediately after placement of the guidewire. The wire advancing mechanism 134 also includes a ring guide 170 and is generally positioned between the slider 18 and the housing 112 to provide forward translation of the wire proximal end relative to the rearward or retracting movement of the slider 18 and the syringe plunger. Specifically, referring to fig. 5, wire advancing mechanism 134 includes a loop guide 170 having an input or distal end 172 positioned to receive wire from wire gripping structure 30 of slider 18 and an output or proximal end 174 for guiding the proximal end of wire 24 and outputting the wire into and through catheter 100, ultimately into and through hub 150, and then ultimately into and through needle 132. The ring guide 170 may be a closed tube, as shown in fig. 5. Alternatively, the loop guide may be open, having a suitable configuration and structure for capturing the wire 24 and guiding it through the loop guide from the distal end 172 to the proximal end 174. As shown in fig. 5, the housing 12 may be suitably formed to include mounting portions 176, 178 that interface with and receive the distal and proximal ends 172, 174, respectively, of the ring guide 170. In the embodiment 110 of the device, the housing 112 includes an extension section 201 that extends rearward on the housing to position the mounting portion 178 rearward from the mounting portion 176 due to the clearance required when handling the catheter arrangement. In this way, space is created in front of the mounting portion 178 to position the catheter arrangement 100, 102 in front of the wire advancing mechanism 134 so that the wire can pass through the catheter arrangement on its way to the needle 132. That is, the wire advancing mechanism is located rearward of the catheter arrangement. More specifically, the output or proximal end 174 of the mechanism 134 is positioned behind the catheter arrangement so that the wire can exit the output end and directly into the catheter arrangement. To secure the catheter arrangement, one or more additional mounting sections 180 may be implemented in the housing 12 and/or on the extension section 201 for holding a portion of the catheter arrangement. Referring to fig. 5, the additional mounting section 180 may have a slot 181 formed therein for receiving elements that make up the catheter arrangement. The catheter arrangement may snap into slot 181 or otherwise be secured. In a similar manner to device 10, negative pressure or vacuum may be drawn through syringe body 14 by movement of the slider/plunger in the direction of arrow 62, and at the same time, proximal end 26 of the wire will advance into the vasculature or another working space in the direction of arrow 63 or in the direction of movement of needle 32, as described herein.

In the embodiment of the device 110, the needle structure must accommodate the fact that: it cannot slide off and be removed from the wire in the same manner as the device 10. This is because the catheter arrangement 100, 102 is behind the needle and prevents the needle from sliding back and being removed from the wire. Instead, device 110 implements needle 132 and hub 150 that can be broken or disassembled for removal from the wire. More specifically, hub 150 may include a weakened section, such as along score line 151, which would allow the hub to be divided into two halves or smaller sections to be removed from wire 24, and then allow the catheter arrangement to be slid down to the position where the wire is inserted into the working space. Needle 132 is also in the form of a peel-off or broken needle to facilitate removal of the entire hub 150 and needle 132.

More specifically, device 110 includes a suitable hub 150 for coupling needle 132 with the device. In particular, hub 150 couples needle 132 with syringe body 14 and wire 24 simultaneously. Referring to fig. 6E, hub 150 includes a guide channel 152 for guiding movement of wire 24 into and through needle 132. Hub 150 also includes a vacuum channel 154 coupled with syringe body 14 to create a negative pressure in the needle when the syringe plunger is moved to the retracted position shown in fig. 6E. Movement of the slider and syringe plunger to the retracted position draws negative pressure within needle 132 through hub 150 to prevent rearward movement of the slider and syringe plunger to the retracted position, as described herein. Once the needle tip penetrates the tissue into the vasculature or other working space, the needle tip is no longer blocked or occluded and the negative pressure is broken so that air/fluid from the working space is drawn into the needle and syringe body. As fluid/air is pulled through the needle, the slider and syringe plunger can then be easily pulled back into the retracted position in the device 110. The movement of the slide/plunger also simultaneously moves the wire gripping structure 30 rearward relative to the needle 132 and thus pushes the wire 24 through the wire advancing mechanism 134. This turns or reverses or translates the wire movement and advances the proximal end 26 of the wire through the needle 132, as shown in fig. 6D.

In the embodiment of the invention shown in fig. 5, hub 150 creates an airtight passageway in both vacuum passageway 154 and guide passageway 152. The needle 132 is sized so that as the wire 24 moves forward within the needle, the needle bore allows the wire 24 to pass in addition to simultaneously allowing air and/or fluid to pass rearward through the needle 132. Hub 150 forms vacuum channel 54, needle interior channel 133, and intersection 160 with guide channel 52 of wire 24. Thus, the mount 150 operates similarly to the hub 50 shown in fig. 1. To this end, hub 150 also includes a sealing mechanism 164 that engages guide channel 152 and wire 24 for providing an airtight seal therein. That is, as the wire 24 passes through the sealing mechanism and into the guide channel 152, the sealing mechanism engages the wire so that the wire 24 may move through the guide channel of the needle mount and through the needle 32 while fluid and air are aspirated by movement of the plunger 20 within the syringe body 14, as shown in fig. 6E.

According to one aspect of the invention, the housing 112 and the syringe body 14 may be formed as a unitary structure, with the housing being part of the syringe body. In another embodiment of the invention, the housing is configured to couple with a separate syringe body, wherein the syringe body is in position relative to the housing gripping portion 16. Similarly, the slider 18 may be formed as a single piece with the syringe plunger such that the slider and wire gripping structure move as the syringe plunger is moved. Alternatively, the slider 18 may be formed to couple to a separate syringe plunger so as to couple movement of the slider to the syringe plunger and movement of the wire to the plunger. Thus, a device having a housing 12 and a slider 18 may utilize a typical syringe having a syringe body and a syringe plunger, as shown in FIG. 1A.

Fig. 6A-6J illustrate the use of the embodiment of the device 110 illustrated in fig. 5. The device 110 provides an integrated solution for delivering guide wires, catheters and other elements to a target space. Referring to fig. 6A, in use, the device 110 is loaded with the catheter 100, dilator 102, and other elements, such as the port 104 preloaded or positioned on the wire 24. It should be noted that the examples and elements shown in fig. 6A are not limiting, and other elements may be preloaded onto the wire 24. The housing 112 includes a mounting section 180 into which the catheter assembly may be loaded. For example, the mounting section 180 may be clipped onto the catheter 100. The wire 24 may then be passed through the advancement mechanism 134 and through the catheter arrangement and into the needle 132. The wire gripping structure 30 may be manipulated to grip the distal end while the proximal end of the wire penetrates into the needle 132. Fig. 6B shows the device 110 loaded with a catheter arrangement and wire such that the catheter arrangement and wire are in line with the housing 112 for performing a procedure with the device 110. As shown in fig. 6C, when the device 110 is in use, the grip portions 16 and 22 engage and pressure is applied to the slider 18 and grip portion 22 by movement of the user's finger in the direction of arrow 62. The wire 26 may be advanced into the target space. As discussed herein with respect to fig. 4B, once the negative pressure is released and the plunger and slide 18 are able to slide more freely rearward relative to the syringe body and housing 112, the wire will advance into the target space. As shown in fig. 6D, as the slider 18 moves further in the opposite direction toward the retracted position, the wire will advance in the direction of arrow 63. This then positions the guide wire in line with the catheter arrangement to further insert the catheter arrangement into the target space. Referring to fig. 6E and 6F, once the wire is positioned into the working space, the device 110 may be removed from the catheter arrangement and wire 26.

Fig. 6E and 6F illustrate that after the needle has been inserted into the target space and any air or fluid has been drawn into the syringe body 14 (as indicated by arrow 15), the device 110 is no longer needed once the wire has been properly positioned within the target space. The catheter arrangement may be removed from the device 110. The device may be removed from needle 132 and hub 150. Fig. 6F shows the exposed catheter 100, dilator 102, and wire 24 with the device 110 removed. Hub 150 is held in place with needle 132. Needle hub 150 and needle 132 cannot simply slide off of wire end 24 due to the in-line position of the catheter and dilator on and behind the wire 24 portion of the working space. For this reason, when using the device 110 with a wire and in-line catheter arrangement, the hub 150 and needle 132 must be detached or torn from the wire 24.

Referring to fig. 6G, once the needle and wire have been advanced through tissue 82 into working space 84, such as through access point 83, the needle may be withdrawn as indicated by arrow 85 and only wire 24 left in place within working space 84. However, hub 150 and needle 132 must be disassembled to allow catheter 100 and dilator 102 or any other element of the catheter arrangement to be advanced over wire 24. The catheter arrangement may then be advanced in the direction of arrow 87, as shown in fig. 6H. To this end, the end of hub 150 may be grasped and torn open, as shown in fig. 6H. Typically, the needle 132 will be a separable or peelable needle that can be separated or have at least one side broken to release the wire 24. The needle mount will also be weakened, such as along score line 151, to be separated, as shown in fig. 6H. The two portions of hubs 150a and 150b and the respective halves of needle 132 may be pulled apart in the direction of arrow 89, as shown in fig. 6H. If a double needle is used, as shown in fig. 11-13, one side of the needle may fall off. The needle and hub are then removed. Dilator 102 and catheter 100 may be slid along wire 24 into working space 84, for example through the same tissue entry point 83 created by the needle. Referring to fig. 6I, dilator 102 and catheter 100 are shown in place along wire 24 within working space 84. Once the catheter 100 is properly positioned, the wire 26 and dilator 102 may be withdrawn, as shown in fig. 6J, and then the catheter 100 and any corresponding ports 104 are in place and may be used for the desired medical procedure.

One advantage of the preloaded catheter arrangement of fig. 5 is that the stop structure 13 can be placed on the rear or distal end of the wire. Such a stop structure 13 may prevent the catheter arrangement from falling off the back of the wire or may prevent the rear end of the wire from being pulled through the skin. The stop arrangement may be implemented because the needle and hub break or flake off, so that it is not necessary to slide the needle off the wire. Other embodiments of the present invention may utilize a differently positioned and operated wire advancing mechanism, as well as alternative syringe bodies and needles and needle beds, for advancing the wire 26 in a direction opposite the motion of the plunger. Referring specifically to fig. 7-8B, an alternative device 210 is implemented having a housing 212, a grip portion 16, a slider 218, and a wire gripping structure 30 for simultaneous movement of a syringe plunger and wire. However, in the embodiment of the device 210 shown in fig. 7-8B, the wire advancement mechanism 234 is configured to advance the wire distal end 24 through the end 25 of the slider 18 and through the plunger 20. As shown in fig. 8A, the plunger 20 may include an internal passageway 27 through which the wire 24 may be advanced. As shown, the ring guide 270 of the wire advancement mechanism 234 may terminate at the end 25 of the slider that coincides with the end of the plunger, and as the slider 18 and plunger move in the direction of arrow 62, the wire may be guided through the syringe plunger 20 and syringe body 14 to engage the needle hub 250 and needle 232. As shown in fig. 8A, the wire 24, and in particular the distal end 28 of the wire, moves with the slider 18 and its direction is changed by the wire advancement mechanism 234 to advance through the syringe plunger 20, the syringe body 14 and through the needle 232 into the appropriate working space, as shown in fig. 8B. That is, as the slider and plunger move in the direction of arrow 62, the wire moves through needle 232 in the direction of arrow 63, as discussed in various embodiments herein.

According to alternative embodiments of the present invention, different wire advancing mechanisms may be utilized. Figures 1 and 5 show a version with a ring guide. Fig. 9 and 10 illustrate alternative versions configured to actively advance the proximal end of the wire into the needle of the device as the slider moves the syringe plunger from the forward position to the retracted position. In the embodiment of the device 310 shown in fig. 9 and 10, the advancement mechanism is an active mechanism, rather than a passive mechanism as in the ring guide 70. Specifically, the housing 312 is configured to include a movable rack 330. The slider 318 is configured to include opposing racks 332. The rack 330 is configured to transition along the housing 312 in the direction of arrow 63 when the slider 318 and rack 332 are moved to the retracted position in the direction of arrow 62, as shown in fig. 10. Pinion 340 is rotatably mounted relative to housing 312 between two racks 330, 332. As the rack 332 on the slide 318 transitions during movement of the slide and plunger, the pinion rotates in the direction of arrow 341. Further, the pinion 340 acts on the movable rack 330 which is shifted in the direction of the arrow 63. The movable rack 330 includes a wire gripping structure 331 that grips the distal end 28 of the wire 24. In accordance with features of the present invention, as the slider 318 and plunger are moved to the retracted position, the movable rack 330 and wire gripping structure 331 transition in the direction of arrow 63, thereby transitioning the wire 24 through the needle hub 50 and needle 32. Thus, the wire advancing mechanism 334 as shown in fig. 9 and 10 illustrates an embodiment that incorporates active forward movement of the wire rather than passive redirection upon retraction of the plunger. Thus, the wire advancing mechanism as shown and described herein may actively move the wire rather than passively reversing its direction from that of the slider and plunger. An additional use of the active or geared version of the wire advancement mechanism is that the racks and pinions may be adjusted and configured to increase feedback to the user so that when the slider and plunger are moved to the retracted position, the hand movement may be a force feedback that adjusts the speed (increase or decrease) of the wire movement in the working space and the wire movement (increase or decrease) to the user's hand. The passive wire advancing mechanisms currently in use can provide a hand force to wire movement force ratio of 1:1. For example, an active wire propulsion mechanism as shown in fig. 9-10 may provide a higher or lower force ratio based on the transmission.

Fig. 11-13 illustrate alternative embodiments of a hub and needle in accordance with an aspect of the present invention. For example, the needle hubs 50 and 150 shown in fig. 1 and 5 incorporate a sealing mechanism 64 for providing a seal against the movable wire 24 such that as the wire moves through the same bore, negative pressure may be drawn through the needle hub of the syringe body 14 and the plunger 20 through the bore of the needle. Alternatively, a needle having a plurality of channels may be employed such that the channel for sucking the negative pressure is different from the channel for advancing the wire. Referring to fig. 11-13, a double needle for this purpose is shown. Specifically, the dual needle 500 incorporates a needle portion or channel 502 for drawing negative pressure or vacuum with the syringe body 14. In accordance with the present invention, a separate needle portion or channel 504 receives wire 24 for advancement as the slider/plunger is moved to the retracted position. To this end, the hub 506 is configured such that negative pressure may be drawn through the needle channel 502 while the wire 24 is simultaneously advanced through the needle channel 504. To this end, the channels 502, 504 are generally parallel and share a common tip 510 for penetrating tissue and working space. The hub 506 incorporates a suitable aperture 512 for coupling with the tip of the syringe body 14 for initially drawing negative pressure and then subsequently releasing the slider/plunger when the needle is properly placed to move the plunger to the retracted position and move the wire 24 forward into the needle.

Fig. 14 shows another alternative embodiment of a hub and needle arrangement for the device of the present invention. Hub 650 mounts needle 32 in line with the syringe rather than in line with the advancing wire. For this purpose, the vacuum channel 654 is straight and leads to the tip 15 of the syringe. According to the present invention, the wire guide channel 652 is arcuate or otherwise angled to simultaneously feed advancing wire into the needle 32.

While the present invention may be used to place a wire as a guidewire for placement of a central venous catheter, it may be used for other purposes and techniques as well. For example, it may be used for placement of a pigtail chest tube, a pigtail drainage tube for fluid collection, for thoracocentesis and laparoscopy, and for other uses employing percutaneous puncture techniques or for placement of wires or catheters within the body. For example, it may also be used for, but is not limited to, angiographic guidewire placement, central venous wire placement, arterial wire placement, image-guided percutaneous gastrostomy tube placement, small-bore chest tube placement, pacemaker lead wire insertion, central venous pressure insertion monitor, cardiac ablation surgery, percutaneous drainage placement, PICC placement, implantable cardioverter defibrillator insertion, REBOA (aortic resuscitation balloon occlusion), endovascular dialysis fistulization and other endovascular procedures (EVAR, TEVAR, TAVR, thromboembolic resection, intravascular stent placement, thrombolysis). The placed wire may be used as a guide wire to guide other elements into place, or the wire may be an element left in the working space for a medical procedure.

While the present invention has been illustrated by a description of various embodiments and while these embodiments have been described in some detail, the inventors do not intend to limit the scope of the appended claims or to limit in any way thereto. Accordingly, additional advantages and modifications will readily appear to those skilled in the art. The various features of the invention may be used alone or in any combination depending on the needs and preferences of the user.

Claims (20)

1. A device for interfacing with a syringe body and a plunger to deliver a wire into a tissue working space, the device comprising:

a needle configured to couple with the syringe body and having at least one aperture for guiding a proximal end of the wire into the working space;

a housing configured to couple with the syringe body and including at least one portion for engagement by a user;

a slider configured to couple with the syringe plunger for moving the syringe plunger between a forward position and a retracted position, the slider including at least one portion for engagement by a user;

the slider is releasably coupled with a distal end of the wire to move the distal end and advance the proximal end of the wire forward in the needle when the slider moves the syringe plunger from the forward position to the retracted position.

2. The device of claim 1, wherein the slider comprises a wire gripping structure for releasably gripping the distal end of the wire to move the distal end of the wire with the syringe plunger.

3. The device of claim 1, further comprising a wire advancing mechanism for translating movement of the distal end of the wire as the slider moves the syringe plunger from the forward position to the retracted position to advance the proximal end of the wire in the needle.

4. The device of claim 3, wherein the wire advancement mechanism comprises a loop guide for reversing the direction of the wire movement and translating the movement of the wire distal end to advance the wire proximal end.

5. The device of claim 4, wherein the loop guide has a distal end positioned to receive wire from the gripping structure of the slider and a proximal end for guiding the proximal end of the wire into the needle.

6. The device of claim 1, further comprising a needle hub including a guide channel coupled with the at least one needle aperture to guide movement of the wire in the needle and a vacuum channel for coupling with the syringe body to create negative pressure in the at least one needle aperture when the syringe plunger is moved to the retracted position.

7. The device of claim 6, wherein the guide channel is airtight.

8. The device of claim 6, wherein the guide channel is positioned in line with the needle for movement of the wire in the needle.

9. The device of claim 6, wherein the needle comprises two channels, a first of the needle channels being coupled with the guide channel and a second of the needle channels being coupled with the vacuum channel.

10. The device of claim 1, wherein the wire advancement mechanism comprises a gear system releasably coupling the distal end of the wire with the slider such that movement of the syringe plunger from the forward position to the retracted position moves the proximal end of the wire forward in the needle.

11. A device for interfacing with a syringe body and a plunger to deliver a catheter into a tissue working space, the device comprising:

a wire;

a conduit threaded onto the wire;

a needle configured to couple with the syringe body and having at least one aperture for guiding a proximal end of the wire into the working space;

A housing configured to couple with the syringe body and including at least one portion for engagement by a user, the housing releasably securing the catheter;

a slider configured to couple with the syringe plunger for moving the syringe plunger between a forward position and a retracted position, the slider including at least one portion for engagement by a user;

a slider releasably coupled with the distal end of the wire for moving the distal end and advancing the proximal end of the wire through the catheter and the needle into the working space when the slider moves the syringe plunger from the forward position to the retracted position;

the catheter is configured to be released from the housing and slid into the working space along the wire.

12. The device of claim 11, wherein the slider comprises a wire gripping structure for releasably gripping the distal end of the wire to move the distal end of the wire with the syringe plunger.

13. The device of claim 11, further comprising a wire advancing mechanism for translating movement of the distal end of the wire as the slider moves the syringe plunger from the forward position to the retracted position to advance the proximal end of the wire in the catheter and the needle.

14. The device of claim 13, wherein the wire advancement mechanism comprises a loop guide for reversing the direction of the wire movement and translating the movement of the wire distal end to advance the wire proximal end.

15. The device of claim 11, further comprising a dilator threaded onto the needle with the catheter.

16. The device of claim 11, further comprising a needle hub including a guide channel coupled with the at least one needle aperture to guide movement of the wire in the needle and a vacuum channel for coupling with the syringe body to create a negative pressure in the at least one needle aperture when the syringe plunger is moved to the retracted position.

17. The device of claim 11, wherein the needle and hub are detachable from the wire to slide the catheter along the wire into the working space.

18. The device of claim 16, wherein the guide channel is positioned in line with the needle for movement of the wire in the needle.

19. The device of claim 16, wherein the needle comprises two channels, a first of the needle channels being coupled with the guide channel and a second of the needle channels being coupled with the vacuum channel.

20. The apparatus of claim 13, wherein the wire advancement mechanism has an output end positioned behind the catheter such that wire can exit the output end of the wire advancement mechanism and enter the catheter.