Wire and Catheter Placement Devices

Abstract

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

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 125,913, filed December 15, 2020 (pending), and U.S. Provisional Patent Application No. 63 / 215,493, filed June 27, 2021 (pending), the disclosures of which are incorporated by reference in their entireties herein.

[0002] The present invention is directed to a device for positioning a guidewire into tissue, and in particular into a working space in tissue such as the vasculature, for positioning other elements for the performance of a medical procedure. [Background technology]

[0003] In medicine and surgery, it is commonly necessary to position elements such as catheters and other elements into a working space in tissue, such as in the vasculature. The Seldinger technique is often 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. Often, a syringe is attached to the needle, and the user pulls the syringe back to generate negative pressure as the needle is advanced into the skin and tissue. While the needle advances through the skin and subcutaneous tissue, the lumen or bore of the needle is blocked, and the user can only pull the plunger a short distance due to the vacuum and negative pressure created in the syringe. Once the needle tip or bore enters the target space, such as inside a blood vessel, the syringe fills with blood, air, or other fluids under the force of the negative pressure. The user inserting the needle can visualize it to know that the needle is properly positioned.

[0004] Once the needle tip is located within the target space, the syringe is removed from the needle. From there, a flexible wire is threaded through the needle into the target space. The needle is then slid back and removed over the wire. A dilator, a tough plastic piece, is threaded over the wire into the tissue and working space and then removed. A catheter, roughly the same size as the dilator but more flexible, can then be guided over the wire and placed over the wire into the target space.

[0005] One of the current drawbacks of the existing technology is that several problems can occur at various stages, from removing the syringe from the needle to feeding the wire into the needle and working space. It can be awkward and difficult for the user to move and steer the wire. The wire is thin and often moves around. Therefore, the wire may not be sterile if any part of it touches something outside the sterile field. It can also be difficult to advance the wire behind the needle. The needle may move while the syringe is removed and also while the user reaches for the wire and threads it into the needle. In such a situation, the needle may be pulled out of the target space so that the wire cannot be advanced. The needle may also be advanced further than desired. This can cause complications. For example, with internal jugular central venous catheter placement, the carotid artery is often in a posterior position. Therefore, if the needle advances further in the vein than desired, the needle tip may be in the artery without the user knowing it. The wire is threaded into the artery. Therefore, the artery may be dilated. This can lead to serious complications if a larger hole is created in the high pressure arterial system. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is a need for devices and methods that can improve the safety and time efficiency of the Seldinger technique and similar techniques for positioning wires within the body workspace. There is also a need to improve ergonomics and allow the user to more easily draw negative pressure and receive feedback during the process of wire placement. [Means for solving the problem]

[0007] A device for interacting with a syringe body and plunger to deliver a wire into a tissue working space includes a needle configured to couple with the syringe body and have at least one hole for guiding a proximal end of the wire into the working space. A housing is configured to couple with the syringe body and includes a portion for engagement by a user, such as one or more gripping portions. A slider is configured to couple with the 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 said movement. A user can grip the housing and the slider to engage and steer the syringe. The slider is releasably coupled with the distal end to move the distal end of the wire and advance the proximal end of the wire forward within 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 forward within 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 wire distal end to advance the proximal end of the wire forward as a result of the syringe plunger moving to the retracted position. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 is a perspective view of a wire and catheter placement device in accordance with an embodiment of the present invention. [Figure 1A]FIG. 1 is an exploded perspective view of a wire and catheter placement device in accordance with an embodiment of the present invention. [Figure 2A] 2 is a side view of the wire-and-catheter placement device of FIG. 1 in a forward position in accordance with an embodiment of the present invention. [Figure 2B] 2 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. [Figure 3A] 2 is a top view, in partial cross section, of the wire-and-catheter placement device of FIG. 1 in a forward position in accordance with an embodiment of the present invention. [Figure 3B] 2 is a top view, in partial cross section, of the wire-and-catheter placement device of FIG. 1 in a retracted position in accordance with an embodiment of the present invention. [Figure 4A] 2 is a side view of the wire and catheter placement device of FIG. 1 in a forward position, inserting a wire into tissue. [Figure 4B] 2 is a side view of the wire and catheter placement device of FIG. 1 in a retracted position, inserting a wire into a working space in tissue. [Figure 4C] 2 is a side view of the wire and catheter placement device of FIG. 1 showing the catheter apparatus for insertion over a wire into a working space in tissue. [Figure 4D] FIG. 1 is a side view showing a catheter device prepared for insertion into a working space in tissue over an inserted wire in accordance with an embodiment of the present invention. [Figure 4E] FIG. 1 is a side view showing a catheter device inserted into a working space in tissue via an inserted wire in accordance with an embodiment of the present invention. [Figure 4F] FIG. 1 is a side view showing a catheter inserted into a working space in tissue over an inserted wire in accordance with an embodiment of the present invention. [Diagram 5] FIG. 13 is a perspective view of a wire and catheter placement device according to another embodiment of the present invention. [Figure 6A]FIG. 6 is a side view of the wire-and-catheter placement device of FIG. 5 in a forward position, with the wire-and-catheter apparatus prepared for placement in the device. [Figure 6B] FIG. 6 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. [Figure 6C] FIG. 6 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 the catheter device. [Figure 6D] FIG. 6 is a side view of the wire and catheter placement device of FIG. 5 in a retracted position, with the wire advanced for placement of the catheter apparatus. [Figure 6E] FIG. 6 is a top view in partial section of the wire-and-catheter placement device of FIG. 5 in a retracted position, with the wire advanced for placement of the catheter apparatus. [Figure 6F] 6F is a top view, in partial cross section, of the wire-and-catheter arrangement of FIG. 6E with most of the wire-and-catheter placement device of FIG. 5 removed. FIG. [Figure 6G] FIG. 6F is a top view in partial cross section of the wire and catheter device of FIG. 6F inserted into a working space in tissue via a wire inserted in accordance with an embodiment of the present invention. [Figure 6H] FIG. 6F is a top view in partial cross section of the wire and catheter device of FIG. 6G inserted into a working space in tissue with the needle removed. [Figure 6I] FIG. 6F is a top view in partial cross section of the wire and catheter device of FIG. 6G inserted into a working space in tissue. [Figure 6J] FIG. 6I is a top view in partial section of the catheter device of FIG. 6I inserted into a working space in tissue with the dilator removed. [Figure 7] FIG. 13 is a perspective view of a wire and catheter placement device according to another embodiment of the present invention. [Figure 8A]8 is a top view, in partial cross section, of the wire-and-catheter placement device of FIG. 7 in a forward position in accordance with an embodiment of the present invention. [Figure 8B] 8 is a top view, in partial cross section, of the wire-and-catheter placement device of FIG. 7 in a retracted position in accordance with an embodiment of the present invention. [Figure 9] FIG. 13 is a perspective view of a wire and catheter placement device according to another embodiment of the present invention. [Figure 10] FIG. 13 is a side view of the wire and catheter placement device in a forward position. [Figure 11] FIG. 13 is a perspective view of an alternative needle for a wire-and-catheter placement device of an embodiment of the present invention. [Figure 12] FIG. 12 is another perspective view of the alternative needle of FIG. 11. [Figure 13] FIG. 12 is a top view of the alternative needle of FIG. [Figure 14] FIG. 2 is a top view of an alternative device of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] FIG. 1 shows an embodiment of a device 10 for advancing a wire into a space or working space of a body, such as the vasculature of an animal, such as a human. Such advancement of a wire can be used for a number of different medical procedures and is generally referred to as the Seldinger technique. The term vasculature is often used herein to generally refer to a space or working space in tissue in the body, but the use of the present invention is not limited to wire placement within the vasculature alone. Additionally, although the embodiment discussed is for the placement of a guidewire to position other elements within the working space of the body, other wire structures may be inserted with the device, and therefore the elements are referred to herein as "wires."

[0010] The device 10 comprises a housing 12 that includes or is configured to couple with a syringe body 14. The housing defines portions, such as one or more gripping portions 16, for engagement by a user. The housing provides a way to grip the syringe body. A slide element or slide 18 is positioned along the exterior of the housing and is configured to couple with a syringe plunger 20. The syringe plunger 20 moves within the syringe body 14, for example, between a forward position as shown in FIG. 2A and a retracted position as shown in FIG. 2B. The slide 18 also comprises a gripping portion 22 for engagement by a user to move the slide 18 and syringe plunger 20 relative to the housing 12 and syringe body 14. The slide acts as an extension of the plunger. Specifically, slide 18 provides a way for a user to more easily engage and move syringe plunger 20 from a forward position to a retracted position during use of device 10.

[0011] The device 10 steers the wire 24 for delivery and placement within the tissue working space and comprises a wire 24. The wire 24 comprises a proximal end 26 and a distal end 28. A slider is releasably coupled to the distal end for moving the distal end of the wire and thereby advancing the proximal end forward within the needle as the slider moves the plunger from a forward position to a retracted position. The slider 18 in one embodiment as shown in FIG. 1 comprises 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. A needle 32 is coupled to the syringe body 14 and, in accordance with a feature of the present invention, is also configured with a bore for guiding the proximal end 26 of the wire into the vasculature or other working space. More specifically, rearward movement of the slide 18 and associated syringe plunger 20 to a retracted position in the syringe body away from the needle 32 draws negative pressure at the needle. Movement of the slide 18, which releasably grips the wire, attempts to advance the wire 24 through the needle 32 and into the vasculature. To that end, a wire advancement mechanism 34 is generally coupled between the slide 18 and the housing 12, as seen in FIG. 1. The wire advancement mechanism 34 acts on the wire to convert movement in one direction into movement in the other direction. The mechanism 34 is configured to convert movement of the wire distal end into movement for advancing the wire proximal end 26 forward into and through the needle 32 when the slide 18 moves the syringe plunger 20 from a forward position to a rearward or retracted position, as shown in FIG. 2B.

[0012] The purpose of the wire advancement mechanism is to reverse or translate, in one stroke of movement, the rearward movement of the slide 18 and the concomitant movement of the syringe plunger 20 to the retracted position to create forward movement of the proximal end of the wire 24 into and through the needle. As shown in Figures 2A and 2B, a human operator's hand 40 engages the gripping portions 16 and 22 of the housing 12 and slide 18, respectively, and moves the slide along the housing toward the retracted position, as shown in Figures 2A and 2B. The wire gripping structure 30 of the slide 18 in Figure 1 releasably grips the distal end 28 of the wire, and the slide and wire are coupled together. Movement of the slide 18 and syringe plunger 20 to the retracted position moves the distal end of the wire toward the wire advancement mechanism 34. The wire advancement mechanism 34 reverses or converts the rearward movement of the wire distal end into forward or forward movement of the wire proximal end 26 into and through the needle 32. As the slide 18 and plunger 20 are moved further into the retracted position, the wire proximal end 26 is advanced further forward through the needle and ultimately into the vasculature or other working space into which the needle is to be inserted.

[0013] In this manner, the device 10 of the present invention provides a single motion, characteristically smooth forward movement of the wire through the needle 32 and into the vasculature as the plunger is moved to a retracted position and negative pressure is drawn and released in conjunction with the syringe plunger 20, which is moved by the slider 18. The slider 18 is coupled to both the wire and the plunger, and moves both the wire 24 in addition to the syringe plunger 20 with a single stroke or movement of the slider 18, as described further herein.

[0014] The needle 32 is configured to couple with the syringe body and has at least one base or lumen for guiding the proximal end of the wire. The device 10 further comprises a needle mount 50 for coupling the needle 32 with the device. The needle mount 50 couples the needle 32 with both the syringe body 14 and the wire 24. FIGS. 3A and 3B show a top view in cross section of the device with the slide and syringe plunger in a forward position and a top view in cross section of the device with the slide and syringe plunger in a retracted position used for the subsequent advancement of the wire 24. The needle mount 50 comprises a guide passage 52 coupled with the needle bore 33 for directing the movement of the wire 24 into and through the needle 32. The needle mount 50 also comprises a vacuum passage 54 coupled with the syringe body 14 for creating a negative pressure at the needle bore when the syringe plunger is moved to the retracted position as shown in FIG. 3B. As described herein, movement of the slide and syringe plunger to the retracted position as shown in FIG. 3B will draw negative pressure through the needle mount 50 into the needle 32. As long as the needle is occluded by tissue, that negative pressure will generally prevent significant rearward movement of the slide and syringe plunger to the retracted position under the force of the gripper's hand on the gripping portions 16 and 22 of the housing and slide, respectively. The slide and plunger may move slightly to create negative pressure with hand pressure, but will be prevented from easily moving to the fully retracted position. Once the needle tip penetrates the tissue and vasculature and the negative pressure is cut off, the slide and syringe plunger may be more easily retracted or moved to the 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 wire 24 through wire advancement mechanism 34, reversing, reversing or translating the movement of the wire, thus advancing proximal end 26 of the wire forward through needle 32, as shown in FIG. 3B.

[0015] In the embodiment of the invention shown in Figures 1-3B, the needle mount 50 creates an airtight passageway in both the guide passageway 52 as well as the vacuum passageway 54. The needle 32 is hollow and includes a bore 33 sized to allow the passage of the wire 24. The bore 33 is also sized to allow the simultaneous passage of air and / or fluid through the needle 32 as the wire 24 moves within the needle. The needle mount 50 forms an intersection 60 with the vacuum passageway 54, the needle bore 33, and the guide passageway 52 for the wire 24. The syringe body 14 forms an airtight seal with the needle mount 50 and the passageway 54. In one embodiment of the invention as shown in the figures, the syringe body 14 includes a tip 15 that fits into a suitably formed opening or cavity 17 in the needle mount. The vacuum passageway 54 through the engagement of the intersection area 60 and the needle bore 33 provides a connection between the needle 32 and the interior space 19 of the syringe body as shown in Figure 3B. When the syringe plunger 20 is pushed by the user to the retracted position, as indicated by the arrow 62, a pressure is created to draw gas or fluid through the needle 32, through the vacuum passage 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 needle bore 33, the passage 52 guiding the wire 24 also needs to be airtight in the embodiment of FIG. 1. To that end, the needle mount includes a sealing mechanism 64 that engages the guide passage 52 and the wire 24 to provide an airtight seal in the guide passage. That is, the sealing mechanism 64 engages the wire 24 as it passes through the sealing mechanism and into the guide passage 52, such that the negative pressure is maintained and can move through the guide passage of the needle mount and the needle 32 at the same time that the negative pressure is being drawn in through the movement of the plunger 20 in the syringe body 14. In one embodiment, the sealing mechanism 64 can involve a rubber or silicone element having a hole for passing the wire. The wire 24 may be a smooth wire or a coiled wire. The coiled wire may have a coating on its surface or may have a substance applied thereto, such as petrolatum, as a coating material.

[0016] In the present invention, using the needle mount 50 as shown separates the syringe fluid / air passage from the wire passage. This allows the syringe to be removed while the wire is still in the needle and provides the ability to perform the Fabian test while the wire is already positioned or advanced. This can verify that the wire is not in an artery and not in a vein as intended.

[0017] The needle mount 50 has a syringe passage adjacent to the needle but not in line with the needle. Rather, a guide passage is in line with the needle to move the wire straight into the needle. This reduces friction and provides easier advancement. In other embodiments, such as shown in FIG. 14, the syringe or vacuum passage is in line with the needle and the wire enters at an angle. A pre-fabricated needle may be used in the needle hub. Alternatively, the needle may be built directly into the needle hub. In one embodiment, the needle hub may be made from a clear material or may include a clear area to make it easier to see as fluid enters the needle.

[0018] As can be appreciated, the syringe plunger 20 can be configured to mimic a typical syringe plunger having an elongated body portion that terminates at a rubber or plastic stop 21 that seals with the inner wall of the syringe body 14 creating an air-tight and fluid-tight seal. A force applied at the end 23 of the syringe plunger 20 in the direction of arrow 62 will move the syringe plunger 20 and stop 21 to a retracted position as shown in FIG. 3B. FIG. 3A shows the syringe plunger 20 and stop 21 in a forward position, against the end of the syringe body 14 and adjacent to the tip 15. When the needle tip is occluded, a negative pressure is created in the syringe.

[0019] According to one aspect of the invention, the housing 12 is configured to couple with a syringe body. In one embodiment, the syringe body 14 may be formed as one structure with the housing, where the syringe body includes an integrally molded housing and gripping portion. In other embodiments of the invention, the housing 12 may be configured to receive a separate syringe body 14 with the syringe body in position relative to the gripping portion 16 of the housing. Similarly, the slide 18 may be formed and configured to couple with a syringe plunger, or the slide may be formed integrally with an extension of the syringe plunger, or as such an extension, as a single element, such that the slide and gripping portion move as one element with the syringe plunger. Alternatively, the slide 18 may be formed and configured to couple with a separate syringe plunger to couple the movement of one to the other. In this manner, the housing 12 and slide 18 may be configured and dimensioned to receive and utilize a typical syringe having a syringe body and a syringe plunger.

[0020] To that end, FIG. 1A shows an embodiment of the device 10 in which the housing 12 includes a generally cylindrical passageway 17 configured to receive the syringe body 14 for coupling therewith. The slide 18 is configured to slide on or adjacent to the housing 12 and is positioned generally parallel to the housing. A guide element 11 on the housing 12 can engage with the slide 18 to ensure straight movement of the slide to a retracted position relative to the housing and syringe body. The slide 18 has an end 25 with a recess 29 or other structure for engaging with the end 23 of the syringe plunger 20 to retain the end 23 and couple the slide to the plunger. The engagement between the plunger and the slide can be an interference fit, or the end 23 of the plunger can be retained in the recess by one or more tabs 37 that snap onto the end 23. In this manner, the slide acts as an extension of the plunger to move the plunger.

[0021] The housing 12, syringe body 14, slide 18, and syringe plunger 20 may be formed from a suitable material, such as a plastic material that is lightweight and can be sterilized, that provides sufficient rigidity for movement of the plunger within the syringe body as well as gripping and guiding the wire 24.

[0022] In accordance with one aspect of the invention, the wire advancement mechanism 34 is configured to advance the proximal end of the wire forward into and through the needle as the slide moves the syringe plunger from the forward position to the retracted position. That is, the wire advancement mechanism 34 functions to translate or change the direction of the wire such that moving the syringe plunger back to the retracted position away from the needle actually simultaneously advances the wire forward into the needle, forward through the needle, and ultimately into the vasculature that the needle penetrates as described herein. This proceeds in a single, fluid motion where moving the plunger to the retracted position simultaneously advances the wire forward into the needle.

[0023] 1-3B show one wire advancement mechanism 34 according to an embodiment of the present invention that includes a loop guide 70 for reversing or changing the direction of wire travel. The loop guide is generally positioned between the slide 18 and the housing 12 to provide a reversal or change in the direction of wire travel relative to the movement of the slide 18 and the syringe plunger. Specifically, with reference to FIG. 1, the wire advancement mechanism 34 includes a loop guide 70 having an input or distal end 72 positioned to receive the wire from the wire gripping structure 30 of the slide 18, and an output or proximal end 74 for guiding the proximal end of the wire 24 and outputting the wire to the needle attachment 50 and ultimately to the needle 32. The loop 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. 1, the housing 12 may be suitably formed with mounting areas 76, 78 that interact with and accommodate the distal and proximal ends 72, 74, respectively, of the loop guide 70. Depending on the length of the housing as well as the length of the loop guide 70, the length of the syringe body, the length of the slider, and the length of the syringe plunger, one or more additional mounting areas 80 may be implemented in the housing 12 to hold a portion of the loop guide 70 between the distal and proximal ends 72, 74. As shown in FIG. 2A, the wire 24 is accommodated by the loop guide 70 which reverses the direction of movement of the wire 24 and 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 that manner, rearward movement of the slide 18 and plunger in the direction of arrow 62 can draw negative pressure or vacuum through the syringe body 14 while, when the pressure is released, the proximal end 26 of the wire advances forward in the direction of arrow 63, or in the direction of movement of the needle 32 into the working space as described herein.

[0024] With respect to the wire 24 specifically and its ends or sections, the terms proximal and distal as used herein are used to indicate one end proximal to the body which travels through the needle and into the working space, and the other end which is spaced away from the needle and is grasped and pushed by movement of the slide 18 and plunger. This refers generally to sections or portions of the wire relative to one another, rather than specifically to the tip or end of the wire. Thus, the proximal end 26 of the wire 24 refers to the portion or section which travels into and / or through the needle, while the distal end 28 of the wire refers to the portion or section of the wire which is releasably coupled to the slide 18 and is moved by the slide to push the proximal end of the wire into a position within the tissue working space.

[0025] 4A-4F show the use of the present invention and the method of the present invention for performing the Seldinger technique or other techniques for positioning wires and other elements, such as catheters, into the vasculature, some other cavity, or working space of a patient. The device 10 is grasped by a user's hand 40 for engaging the syringe. Specifically, the fingers of the hand are positioned at various gripping portions 16 and 22 of elements connected to or on a portion of the syringe. Generally, the gripping portion 16 of the housing is held by the user's hand 40 and fingers, while the index finger or other fingers are positioned adjacent to the gripping portion 22 of the slide 18 for moving the slide relative to the housing. In this manner, the syringe body and plunger are engaged for movement.

[0026] FIG. 4A shows the vasculature of an animal, such as a human, including one or more layers of skin or tissue 82 that define or define an internal passageway (work space) 84 that carries the patient's blood. The device 10 is grasped 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 the bore of the needle 32 are initially blocked by the skin and subcutaneous tissue 82. A retraction force in the direction of arrow 62 by the fingers of the user's hand on the gripping portion 22 moves the plunger, which creates and draws in a negative pressure in the syringe body 14 because the needle tip is blocked. Typically, the illustrated movement of the slide 18 is attempting to move the plunger 20 from a forward position to a retracted position, thus drawing air or fluid into the needle 32. However, air or fluid cannot enter the needle 32 because the needle tip 33 is in the subcutaneous tissue or skin 82. Thus, as the user moves the slide 18 and attempts to 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. Generally, the wire 24 may be threaded into the needle 32 and threaded a sufficient distance to be proximate to the tip 33 at the beginning of the process. As shown in FIG. 4A, the proximal end of the wire may be in position at the tip 33 or may be behind the tip when threaded into the tissue 82. The slide 18 may be allowed to move slightly in the direction of arrow 62 before the plunger meets significant resistance from the vacuum being drawn into the syringe body 14. Because movement of the plunger 18 and associated wire gripping structure 30 moves the wire 24 slightly, it is generally desirable to position the tip of the wire proximal end 26, or the terminus of the wire, slightly back from the needle tip 33 at the beginning of the procedure so that it does not move out of the needle during the short initial retraction of the plunger and vacuum. The distance can be determined by the size of the syringe body / plunger and can be adjusted as desired by the user by manually moving the wire within the gripping structure 30 so that the device 10 can be customized to the desired amount of negative pressure and sliding movement before the distal end of the wire moves out of the tip of the needle 33.In one embodiment, the wire may be backed off one to two centimeters from the tip. Space 84, such as the working space within the vasculature defined by tissue 82, is the ultimate target not only for the tip of needle 33, but also for wire 24.

[0027] 4B, once the needle 32 has been passed through tissue 82 into space 84, fluid / air can be drawn in and there is no longer a negative pressure or vacuum. Therefore, the slide 18 and syringe plunger 20 can be more easily moved in the direction of arrow 62. That is, with the needle tip 33 in space 84 and no vacuum, the slide and syringe plunger can be retracted further back to the retracted position as shown in FIG. 4B. That movement moves the distal end 28 of the wire 24 towards the wire advancement mechanism 34. That is, for the embodiment of loop guide 70 shown in FIGS. 4A-4F, the wire is moved towards and through the loop guide 70 and the direction is reversed to move the wire proximal end 26 in the direction of the needle, reflected by arrow 86 as shown in FIG. 4B. That is, according to one aspect of the invention, the wire advancement mechanism is configured to translate or reverse the wire movement as the slide 18 moves the syringe plunger 20 from a forward position to a retracted position, advancing the proximal end 26 of the wire forward into and through the needle. As will be appreciated, the retracted position can be any position of the syringe body rearward of the forward-most position at which vacuum is drawn. As such, the retracted position is not an absolute rearward position of the syringe plunger in the syringe body, but generally relative to the forward position. The user controls the retraction of the slide and plunger. When the distal end 28 of the wire is moved rearward with the slide 18, the proximal end of the wire 24 is advanced through the needle 32 and into the target space 84. As stated, while the examples described herein discuss movement of a wire into the vasculature, the target space may be any suitable blood vessel, abscess, or body cavity, or other target in a patient, and thus use of device 10 is not limited to a particular vasculature, although vasculature is used herein as a term to broadly describe the target space of a wire in a patient.

[0028] Once the wire 24 is placed into the target space, the distal end 28 of the wire can be removed from the wire gripping structure 30. To that end, the gripping structure 30 can include a lever arm 31, as shown in FIG. 1, that can be squeezed to open the wire gripping structure 30 and release the distal end 20 of the wire 24. The wire 24 is then free to be manipulated by the user, rather than being coupled to the slide 18 and plunger. Because the wire 24 is already in the target space 84, small unintentional movements of the wire by the user will not remove it from the target space 84. With reference to FIG. 4B, the wire 24 is generally graspable at the exposed area reflecting the distal end 28, as well as at a portion of the wire proximal to the housing 12, rearward of the proximal end 26. The user can grasp the wire at any of the exposed locations for further manipulation. For example, the device 10 can be held by one hand while the user's other hand can be used to further advance the wire. Once the wire has been advanced a desired distance within space 84, the wire can be used to insert other elements into the target space 84. For example, the wire can be used to advance a catheter with a dilator into the space.

[0029] Referring to FIG. 4C, the device 10, specifically the needle 32 and the needle mount 50, can be removed from the wire. However, it may be desirable to initially only remove the syringe body and the remainder of the device from the needle mount, leaving the needle in place for additional procedures. For example, a Fabian test can be performed by attaching tubing to an opening in the needle mount that is connected to the vacuum passage 54, or to a passage that is originally connected to the syringe body 14. For procedures such as positioning the catheter 100, the device 10 including the needle 32 and the needle mount 50 is removed and pulled up from the wire, as shown in FIG. 4C. Specifically, the device 10, the needle 32, and the needle mount 50 can be removed in the direction of the arrow 90 from the wire 24 that is positioned in the space 84. The wire 24 may be for the purpose of guiding and positioning the catheter into the target space 84, such that in some uses the wire 24 is used for guidance. Referring again to FIG. 4C, the catheter 100 about the dilator 102 is threaded over the distal end 28 of the wire once the device 10 and needle 32 are removed.

[0030] 4D, once the wire 24 has been threaded into the dilator 102 and catheter 100, the elements may be slid through an opening in the tissue 82 and through the same opening utilized to insert the wire. As shown in FIG. 4E, the dilator 102 and catheter 100 may be positioned within the space 84 for further treatment. 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, or they may be removed simultaneously, to leave the catheter 100 in place for performance of further treatment within the target space 84, such as the vasculature.

[0031] The device 10 offers considerable advantages over techniques for introducing and advancing wires and other elements into a target space in a patient. The device 10 directly couples the retraction of the syringe plunger to the advancement of the wire 24 through the releasable wire gripping structure 30. The same force used to move the slide and plunger is generally the same force used to move the wire into the needle and working space. That is, there are no intervening mechanisms in the device 10 so that the tactile feedback of the wire movement is directly on the plunger, slide, and the user's fingers. Thus, the wire can be advanced once the needle tip is in any target vessel, abscess, body cavity, or other space. With one hand, the user can position the wire into the target space. The function of the syringe body 14, the movement of the syringe plunger within the syringe body 14 through the slide 18, and the movement of the wire through the loop 70 are the only resistance encountered by the user, thus allowing for greater tactile feedback in the process. The direct coupling between the movement of the syringe plunger and the simultaneous advancement of the wire gives the user a better sense of how the wire is advancing and provides quicker feedback that the wire may not be advancing properly. For example, if the wire is advancing into a vessel wall or occlusion, or if the needle is withdrawn from the target space prior to wire advancement, the user has immediate feedback via the housing, slide, and gripping portions 16 and 22 on the housing 12 and slide 18. Additionally, the wire 24 advances external to the syringe housing 12 or syringe plunger as shown in FIG. 1. As discussed further herein, this allows other elements to be preloaded onto the wire for placement with the wire in the target space 84.

[0032] The device 10, and other alternative embodiments of the invention described herein, may be held in one hand for use generally providing a single movement. In alternative embodiments, a robotic engagement rather than a hand may be used. The wire may be advanced with the same hand or movement that pulls the syringe plunger. The user is in control of the advancement of the wire, and no spring, lever intervention, or other mechanism takes that control away from the user. If the wire meets resistance as felt in the device, the user may stop moving the plunger and advancing the wire. Furthermore, an additional advantage is that the device 10 and its associated embodiments permit longer wires to be used. The wire advancement mechanism 34, specifically the loop guide 70 or other guidance structure, may be configured and dimensioned based on the desired length of the wire. As such, additional wires may be preloaded with catheters / sheaths and dilators for introduction over the wire into the target space as discussed further herein. According to another feature of the invention, different sized syringe bodies 14 may be used with different amounts of fluid from the target space correlated to greater or lesser movement of the wire based on movement of the slider and wire gripping structure 30. That is, when a syringe body 14 and syringe plunger with a larger diameter is used, more air / fluid is required to translate the slider back and move the syringe plunger to a retracted position a particular distance. A smaller diameter syringe body 14 and syringe plunger 20 may be used when it is preferred to more minimally move the amount of air / fluid through the syringe to advance the wire a desired distance. The lack of coupling between the wire and the syringe and the ability to accommodate the retraction of fluid is useful when the target space is small. This ability to move the wire without excessive retraction or to move the wire independent of further retraction is advantageous when significant fluid retraction may overwhelm the target space.

[0033] In the present invention, entry into the target space can be determined with one hand of the user, and the wire is advanced forward simultaneously, generally in a single stroke, while the slide 18 and syringe plunger 20 are moved rearward to a retracted position. Furthermore, the force used to advance the wire is generated directly by the user and therefore can be applied more delicately and precisely, as opposed to other mechanisms such as springs or levers that advance the wire. That is, using device 10, there is generally a 1:1 force ratio to retract the plunger and advance the wire. This provides very responsive feedback to the user through the user's hand in using the device and in moving the wire.

[0034] The device 10 and other disclosed embodiments can be used with a range of needle sizes, syringe body sizes, and wire sizes. Tapered wires may be used for the wire elements to facilitate fluid in the needle to pass over the wire and into the syringe body. Additionally, wires with coiled wire tips may be utilized while the remainder of the wire is smooth. That way the seal around the wire can be airtight, but fluid / air can more easily pass around the tip of the wire and into the needle. As stated, the housing 12 and syringe body 14 may be formed as one element. Similarly, the slider 18 and syringe plunger 20 may be integrally formed as one element. Thus, the syringe plunger with its gripping portion and the wire gripping structure will engage the syringe body with its own gripping portion to provide the desired interaction of the components. Alternatively, the housing 12 and slider 18 may be constructed separately from the syringe components. In such a case, the syringe body 14 will fit, snap, or otherwise couple with an appropriately constructed housing 12, while the syringe plunger 20 will fit, snap, or otherwise couple with the slider 18 such that the slider and syringe plunger interact as disclosed.

[0035] The wire gripping structure 30 as shown in Figures 1 and 2A may be a clamp-type structure with opposing clamping ends 33, 35 biased together to frictionally grip or clamp the wire 24 at its distal end 28. A lever structure 31 as shown in Figure 1 may be operated to open and close the clamping ends 33, 35 to grip or release the wire 24. The pair of clamping ends may be utilized to releasably grip the distal end of the wire. The grip must be tight enough to provide the necessary movement of the wire when moving the slide 18 and plunger to the retracted position under the force of the user's hand. Other wire gripping or wire retaining structures may be used as long as the wire is releasable from the plunger / slide movement.

[0036] The present invention provides ergonomic advantages and stability by utilizing one hand of the user. The gripping portion 16 extending from the housing 12 allows, for example, the thumb and one or more of the index, middle, and ring fingers to hold the device and stabilize the syringe body. The gripping portion 22 positioned at the forward end of the slide 18 allows the index finger of the same hand to easily and comfortably move the plunger to draw negative pressure and then subsequently advance the wire in the needle that enters the target space. The thumb and one or more of the index, middle, and ring fingers can firmly support the device 10 and the syringe body, while the index finger can separately control the movement of the slide, the syringe plunger, and the wire. This allows the user to keep the needle tip very stable to prevent removal of the needle from the target space while the wire is being advanced simultaneously.

[0037] FIG. 5 illustrates an alternative embodiment of device 110, similar to device 10, but providing for advancement and positioning of a wire preloaded with a catheter, dilator, or other element into a target space in tissue, such as the human vasculature. As with other embodiments of the present invention, such wire advancement can be used for a number of different medical procedures. Similar elements between device 10 and device 110 share several common reference numbers for common elements. Device 110 comprises a housing 112 including a syringe body 14 and a gripping portion 16 for engagement by a user or configured to couple with syringe body 14 and gripping portion 16. As with device 10, the housing and gripping portion can be part of one syringe body or can be separate from the body. A slide 18 is positioned adjacent to housing 14 and is part of the plunger or configured to couple with a syringe plunger 20. The syringe plunger 20 moves within the syringe body 14, for example, between a forward position as shown in FIG. 6B and a retracted position as shown in FIG. 6C. The slide 18 also includes a gripping portion 22 for engagement by a user to move the slide 18 and syringe plunger 20 relative to the housing 112. Specifically, the slide 18 moves the syringe plunger 20 from a forward position to a retracted position during use of the device 10. As described herein, the housing 112 may be dimensioned to receive a catheter configuration in front of the wire advancement mechanism.

[0038] The device 110 also includes a wire 24. The wire 24 includes a proximal end 26 and a distal end 28. The slidable portion 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 inserted into a target space in tissue as guided by the wire. Specifically, as shown in FIG. 5, a dilator 102 and a catheter 100 (i.e., a catheter device) are loaded onto the wire. The catheter 100 may include one or more ports 104 that feed into the catheter depending on the medical procedure for which the catheter is used. A needle 132 is coupled to the syringe body 14 and is also configured to guide the proximal end 26 of the wire into a working space, such as a vasculature space, in accordance with a feature of the present invention. As with device 10, movement of slide 18 and syringe plunger 20 rearward, away from needle 132 and body, will draw in negative pressure, tending to advance wire 24 in a single movement through the bore of needle 132 and into the vasculature or other target space.

[0039] To that end, a wire advancement mechanism 134 is generally coupled between the slide 18 and the housing 112, as seen in Fig. 1. The wire advancement mechanism 134 is configured to guide the wire and advance the proximal end 26 of the wire forward into the needle 132 when the slide 18 moves the syringe plunger 20 from a forward position to a retracted position, as shown in Fig. 6C.

[0040] The purpose of the wire advancement mechanism is to reverse or translate, in one stroke of movement, the rearward movement of the slide 18 and the concomitant movement of the syringe plunger 20 to the retracted position to create forward movement of the wire 24 into and through the needle 134. As described herein, a human operator's hand, or some other mechanism such as a robot, engages the gripping portions 16 and 22 of the housing and slide, respectively, and moves the slide 18 rearward along the housing to the retracted position, as shown in FIGS. 6B and 6C. The wire gripping structure 30 of the slide 18 grips the distal end 28 of the wire. Movement of the slide 18 and syringe plunger 20 to the retracted position moves the distal end 28 of the wire towards the wire advancement mechanism 134. The wire advancement mechanism reverses or converts the rearward movement of the distal wire end into forward movement of the proximal wire end 26 into and through the needle 132. When the slide 18 and plunger 20 are moved to the retracted position, the proximal wire end 26 is simultaneously advanced through the needle and ultimately into the target space where the needle is inserted, as described herein.

[0041] In the embodiment shown in Figures 5-6J, the housing 112 is configured to pull away the wire advancement mechanism 134 further rearwardly of the housing 112. In accordance with the present invention, the wire advancement mechanism 134 operates similarly to mechanism 34 and is configured to guide the wire and advance the proximal end of the wire forward 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, such as the dilator 102 and catheter 100, to be pre-threaded or pre-positioned on the wire prior to insertion into the working space. The housing is configured to secure the catheter device, so that it provides for immediate placement of the wire in the catheter. The wire advancement mechanism 134 also includes a loop 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 retraction movement of the slider 18 and the syringe plunger. Specifically, and with reference to Figure 5, the wire advancement mechanism 134 comprises a loop guide 170 having an input or distal end 172 positioned to receive the wire from the wire gripping structure 30 of the slide 18, and an output or proximal end 174 for guiding the proximal end of the wire 24 and outputting the wire into and through the catheter 100 and ultimately into and through the needle mount 150 and ultimately into and through the needle 132. The loop guide 170 may be a closed tube as shown in Figure 5. Alternatively, the loop guide may be open with any suitable configuration and structure for capturing and guiding the wire 24 through the loop guide from the distal end 172 to the proximal end 174. 5, the housing 12 may be suitably formed with mounting portions 176, 178 that interact with and accommodate the respective distal and proximal ends 172, 174 of the loop guide 170. In device embodiment 110, due to the clearance required to handle the catheter apparatus, the housing 112 includes an extension section 201 that extends rearwardly on the housing to position the mounting portion 178 rearwardly from the mounting portion 176.In this manner, space is created in front of the mounting portion 178 to position the catheter device 100, 102 in front of the wire advancement mechanism 134 so that the wire can pass through the catheter device on its path onto the needle 132. That is, the wire advancement mechanism is located at the rear of the catheter device. More specifically, the output or proximal end 174 of the mechanism 134 is located at the rear of the catheter device so that the wire can exit the output end and enter the catheter device directly. To secure the catheter device, one or more additional mounting areas 180 may be implemented in the housing 12 and / or in the extension section 201 to hold a portion of the catheter device. With reference to FIG. 5, the additional mounting area 180 may have a slot 181 formed to receive an element that makes up the catheter device. The catheter device may be snapped into the slot 181 or otherwise secured. In a manner similar to device 10, movement of the slider / plunger in the direction of arrow 62 can draw negative pressure or vacuum through the syringe body 14 while simultaneously advancing the proximal end 26 of the wire in the direction of arrow 63, or in the direction of movement of the needle 32 into the vasculature or other working space as described herein.

[0042] In the embodiment of device 110, one must accommodate the fact that the needle structure cannot be slid off the wire in the same manner as device 10. This is because the catheter device 100, 102 is positioned behind the needle, preventing the needle from being slid backwards and removed from the wire. Rather, device 110 implements a needle 132 and needle mount 150 that can be broken off or disassembled for removal from the wire. More specifically, the needle mount 150 can incorporate a weakened area, such as along a score line 151, that allows separation of the needle mount into halves or smaller areas to remove the needle mount from the wire 24 and slide the catheter device over the wire into position in the working space. The needle 132 can also be in the form of a peel-off or break-off needle to facilitate removal of the needle mount 150 and the entire needle 132.

[0043] More specifically, the device 110 includes a suitable needle mount 150 for coupling the needle 132 to the device. Specifically, the needle mount 150 simultaneously couples the needle 132 to both the syringe body 14 and the wire 24. Referring to FIG. 6E, the needle mount 150 includes a guide passage 152 for directing the movement of the wire 24 into and through the needle 132. The needle mount 150 also includes a vacuum passage 154 that is coupled with the syringe body 14 for creating a negative pressure in the needle when the syringe plunger is moved to a retracted position as shown in FIG. 6E. As described herein, the movement of the slide and syringe plunger to the retracted position draws a negative pressure into the needle 132 through the needle mount 150 to prevent rearward movement of the slide and syringe plunger to the retracted position. Once the needle penetrates through the tissue into the vasculature or other working space, the needle tip is no longer blocked or occluded and the negative pressure is broken such that air / fluid from the working space is drawn into the needle and syringe body. Thus, the slide and syringe plunger can be easily retracted rearward in the device 110 to a retracted position as fluid / air is pulled through the needle. The movement of the slide / plunger also simultaneously moves the wire gripping structure 30 rearward relative to the needle 132, thereby pushing the wire 24 through the wire advancement mechanism 134. This reverses, reverses, or translates the movement of the wire, advancing the proximal end 26 of the wire forward through the needle 132, as shown in FIG. 6D.

[0044] In the embodiment of the invention shown in FIG. 5, the needle mount 150 creates an airtight passage in both the guide passage 152 as well as the vacuum passage 154. The needle 132 is sized such that the needle aperture permits passage of the wire 24 through the needle 132 as the wire 24 moves forward within the needle, in addition to the simultaneous rearward passage of air and / or fluid through the needle 132. The needle mount 150 forms an intersection 160 for the vacuum passage 54, the needle's internal passage 133, and the guide passage 52 for the wire 24. As such, the mount 150 operates similarly to the needle mount 50 shown in FIG. 1. To that end, the needle mount 150 also includes a sealing mechanism 164 that engages the guide passage 152 and the wire 24 to provide an airtight seal in the guide passage. That is, the sealing mechanism engages the wire 24 as it passes through the sealing mechanism and into the guide passage 152 so that the wire 24 can move through the guide passage of the needle attachment and the needle 32 at the same time as negative pressure and / or fluid and air are being drawn in through movement of the plunger 20 within the syringe body 14, as shown in FIG. 6E.

[0045] According to one aspect of the invention, the housing 112 and the syringe body 14 may be formed as one structure, with the housing being part of the syringe body. In other embodiments of the invention, the housing is configured to couple with a separate syringe body, with the syringe body in position relative to the gripping portion 16 of the housing. Similarly, the slide 18 may be formed integrally with the syringe plunger as a single element, such that the slide and the wire gripping structure are moved when the syringe plunger is moved. Alternatively, the slide 18 may be formed to couple with a separate syringe plunger, to couple the movement of one to the other and the movement of the wire to the plunger. In that way, a device with the housing 12 and slide 18 may utilize a typical syringe with a syringe body and syringe plunger as shown in FIG. 1A.

[0046] 6A-6J show an implementation of the device 110 as shown in FIG. 5. The device 110 provides an all-in-one solution for the delivery of guidewires, catheters, and other elements to a target space. Referring to FIG. 6A, during use, the device 110 is loaded with other elements, such as the catheter 100, the dilator 102, and the port 104 that are pre-loaded or positioned on the wire 24. As stated, the examples and elements shown in FIG. 6A are not limiting, and other elements may be pre-loaded on the wire 24. The housing 112 includes a mounting area 180 to which the catheter assembly may be loaded. For example, the mounting area 180 may clip onto the catheter 100. The wire 24 may be threaded through the advancement mechanism 134 and catheter configuration into the needle 132. The wire gripping structure 30 may be manipulated to grip the distal end while the proximal end of the wire is threaded into the needle 132. FIG. 6B shows the device 110 with the catheter device and wire mounted such that they are aligned with the housing 112 for the performance of a procedure utilizing the device 110. As shown in FIG. 6C, when the device 110 is used, the gripping portions 16 and 22 are engaged and pressure is applied to the slider 18 and gripping portion 22 by the movement of the user's fingers in the direction of arrow 62. The wire 26 can be advanced into the target space. As discussed herein with respect to FIG. 4B, the wire will advance into the target space when the negative pressure is released and the plunger and slider 18 can slide more freely backward relative to the syringe body and housing 112. As shown in FIG. 6D, the wire will advance in the direction of arrow 63 when the slider 18 is moved further in the opposite direction toward a retracted position. This thus positions the guidewire in line with the catheter device for further insertion of the catheter device into the target space. 6E and 6F, the device 110 may be detached from the catheter apparatus and wire 24 once the wire is positioned into the working space.

[0047] 6E and 6F show that after penetration of the target space by the needle and drawing of air or fluid into the syringe body 14 as indicated by arrow 15, the device 110 is no longer needed once the wire is properly positioned within the target space. The catheter device can be removed from the device 110. The device can be removed from the needle 132 and the needle mount 150. FIG. 6F shows the exposed catheter 100, dilator 102, and wire 24 with the device 110 removed. The needle mount 150 remains in place along with the needle 132. Due to the in-line position of the catheter and dilator on and behind the wire 24 portion of the working space, the needle mount 150 and needle 132 cannot simply slide off the end of the wire 24. Therefore, in using the device 110 with both the wire and the in-line catheter device, the needle mount 150 and needle 132 must be broken or torn off the wire 24.

[0048] 6G, once the needle and wire have entered the working space 84 through the tissue 82, such as through the entry location 83, the needle may be withdrawn as indicated by arrow 85, leaving only the wire 24 in place within the working space 84. However, the needle attachment 150 and needle 132 must be broken free to permit advancement of the catheter 100 and dilator 102, or any other element of the catheter device on the wire 24, so that the catheter device can proceed in the direction of arrow 87, as shown in FIG. 6H. To do so, the ends of the needle attachment 150 can be gripped and torn apart, as shown in FIG. 6H. Generally, the needle 132 is a break-away or peel-away needle that can be split or have at least one lateral pull-away to free the wire 24. The needle attachment can also be weakened, such as along a score line 151, to allow separation, as shown in FIG. 6H. The two parts 150a and 150b of the needle attachment, along with the respective halves of the needle 132, can be pulled apart in the direction of arrows 89 as shown in FIG. 6H. If a dual barrel needle is used as shown in FIGS. 11-13, one side of the needle may be peeled away. The needle and attachment are then removed. The dilator 102 and catheter 100 can be slid along the wire 24 into the working space 84, such as through the same tissue entry location 83 created by the needle. Referring to FIG. 6I, the dilator 102 and catheter 100 are shown in position along the wire 24 within the working space 84. Once the catheter 100 is properly positioned, the wire 26 and dilator 102 can be withdrawn as shown in FIG. 6J, so that the catheter 100 and respective ports 104 are in place and available for the desired medical procedure.

[0049] One advantage of the pre-loaded catheter device in FIG. 5 is that a stop structure 13 may be placed at the trailing or distal end of the wire. Such a stop structure 13 may prevent the catheter device from falling off the trailing end of the wire or from being pulled past the skin. A stop structure may be implemented so that the needle and attachment break or peel off, eliminating the need to slide the needle off the wire. Other embodiments of the invention may utilize alternative syringe bodies, needles, and needle attachments for advancing the wire 26 in a direction opposite to the movement of the plunger, as well as wire advancement mechanisms that are positioned and operated differently. Specifically, referring to FIGS. 7-8B, an alternative device 210 is implemented having a housing 212, a gripping portion 16, a slider 218, and a wire gripping structure 30 for simultaneous movement of the syringe plunger and wire. However, in the embodiment of device 210 shown in Figures 7-8B, wire advancement mechanism 234 is configured to present wire distal end 24 for advancement through end 25 of slide 18 and plunger 20. As shown in Figure 8A, plunger 20 may include an internal passage 27 through which wire 24 may advance. As shown, loop guide 270 of wire advancement mechanism 234 may terminate at end 25 of the slide coincident with the end of the plunger, and the wire may be guided through syringe plunger 20 and syringe body 14 to engage needle mount 250 and needle 232 when slide 18 and plunger are moved in the direction of arrow 62. As shown in Figure 8A, wire 24, and specifically distal end 28 of the wire, moves with slide 18 and its direction is changed by wire advancement mechanism 234 to advance through syringe plunger 20, syringe body 14, and needle 232 into the appropriate working space, as shown in Figure 8B. That is, as the slide and plunger move in the direction of arrow 62, the wire moves in the direction of arrow 63 through needle 232, as discussed in various embodiments herein.

[0050] According to alternative embodiments of the invention, different wire advancement mechanisms may be utilized. Figures 1 and 5 show one with a loop guide. Figures 9 and 10 show an alternative configured to actively advance the proximal end of the wire forward into the needle of the device when the slider moves the syringe plunger from a forward position to a retracted position. In the embodiment of the device 310 as shown in Figures 9 and 10, the advancement mechanism is an active mechanism rather than a passive mechanism like the loop guide 70. Specifically, the housing 312 is configured with a movable rack gear 330. The slider 318 is configured with an opposing rack gear 332. The rack gear 330 is configured to translate in the direction of arrow 63 along the housing 312 when the slider 318 and rack gear 332 are moved in the direction of arrow 62 to a retracted position as shown in Figure 10. A pinion gear 340 is rotatably mounted relative to the housing 312 between the two rack gears 330, 332. The pinion gear rotates in the direction of arrow 341 when the rack gear 332 on the slide 318 is translated during movement of the slide and plunger. In turn, the pinion gear 340 acts on a movable rack gear 330 which is translated in the direction of arrow 63. The movable rack gear 330 includes a wire gripping structure 331 which grips the distal end 28 of the wire 24. When the slide 318 and plunger are moved to a retracted position, the movable rack gear 330 and wire gripping structure 331 are translated in the direction of arrow 63, thereby translating the wire 24 through the needle mount 50 and needle 32 in accordance with a feature of the present invention. Thus, the wire advancement mechanism 334 as shown in Figures 9 and 10 illustrates an embodiment incorporating active forward movement of the wire upon retraction of the plunger, rather than a passive change of direction. In this manner, the wire advancement mechanism as shown and described herein can actively move the wire rather than passively reversing the direction of the wire from the direction of the slide and plunger.One additional use of an active or geared wire advancement mechanism is that the rack and pinion gears can be adjusted and configured to increase feedback to the user so that hand movement when moving the slider and plunger to the retracted position can be adjusted in both the speed of wire movement in the workspace (increasing or decreasing) and the feedback of the force of the wire movement to the user's hand (increasing or decreasing). Current uses of passive wire advancement mechanisms may provide a 1:1 ratio of hand force to wire movement force. An active wire advancement mechanism such as that shown in Figures 9-10 can provide a higher or lower force ratio based on, for example, gears.

[0051] 11-13 show alternative embodiments of needle mounts and needles according to aspects of the present invention. For example, needle mounts 50 and 150 as shown in Figs. 1 and 5 incorporate a sealing mechanism 64 to provide a seal against the movable wire 24 so that as the wire moves through the bore of the needle, negative pressure can be drawn through the needle mount and plunger 20 of the syringe body 14 through the same bore. Alternatively, needles with multiple passages may be implemented so that the passage used to draw negative pressure is different from the passage that advances the wire. With reference to Figs. 11-13, a dual needle is shown for that purpose. Specifically, the dual needle 500 incorporates a needle portion or needle passage 502 for drawing negative pressure or vacuum using the syringe body 14. Another needle portion or needle passage 504 receives the wire 24 for advancement by moving the slider / plunger to a retracted position according to the present invention. To that end, the needle mount 506 is configured such that negative pressure can be drawn through the needle passageway 502 while simultaneously advancing the wire 24 through the needle passageway 504. To that end, the passageways 502, 504 are generally parallel and share a common pointed tip 510 for penetration into the tissue and working space. The needle mount 506 incorporates a suitable opening 512 for coupling with the tip of the syringe body 14 to first draw in negative pressure and subsequently release the slide / plunger at proper placement of the needle to move the plunger to a retracted position and advance the wire 24 forward into the needle.

[0052] 14 shows another alternative embodiment of a needle mount and needle configuration for the device of the present invention. The needle mount 650 mounts the needle 32 in-line with the syringe rather than in-line with the advancing wire. To that end, the vacuum passage 654 is straight and feeds into the tip 15 of the syringe. The wire guide passage 652 is arced or otherwise angled in accordance with the present invention to simultaneously feed the advancing wire into the needle 32.

[0053] The present invention may be used to place wires as guidewires for central venous catheter placement, but may also be used for other purposes and techniques. For example, the present invention may be used to place pigtail chest tubes, pigtail drains for fluid withdrawal, for thoracentesis and paracentesis, and for other uses where the Seldinger technique is used or wires or catheters are placed in the body. The present invention may be used, without limitation, for the placement of wires for angiography, central venous line placement, arterial line placement, image-guided percutaneous gastrostomy tube placement, small bore chest tube placement, pacemaker lead insertion, central venous pressure monitor insertion, cardiac ablation procedures, percutaneous drain placement, PICC placement, implantable cardioverter defibrillator insertion, REBOA (resuscitation balloon occlusion of the aorta), endovascular dialysis fistula creation, and other endovascular procedures (EVAR, TEVAR, TAVR, thromboembolization, endovascular stent placement, thrombolysis). The placed wire may be used as a guidewire to guide other elements into position, or the wire may be an element that is left in the working space for the medical procedure.

[0054] While the present invention has been illustrated by the description of various embodiments, and these embodiments have been described in some detail, it is not the intention of the inventors to restrict or in any way limit the scope of the appended claims to such detail. Accordingly, additional advantages and improvements will readily occur to those skilled in the art. The various features of the present invention may be used alone or in combination, depending on the needs and preferences of the user. [Explanation of symbols]

[0055] 10 Devices 11 Guidance elements 12. Chassis 13 Stop structure 14 Syringe body 15 Tip 16 Gripping part 17 Openings, cavities and passages 18 Sliding elements, sliding parts 19 Interior Space 20 Syringe Plunger 21 Stop part 22 Gripping part 23 ends 24 Wire 25 ends 26 Wire proximal end 27 Internal passage 28 Wire Distal End 29 Dent 30 Wire holding structure 31 Lever arm, lever structure 32 needles 33 Needle hole, needle tip 33, 35 Clamp end 34 Wire advance mechanism 40 moves 50 Needle attachment part 52 Guideway 54 Vacuum passage 60 Intersection 64 Sealing mechanism 70 Loop guide 72 Input end, distal end 74 Output end, proximal end 76, 78, 80 Installation area 82 Skin, tissue, subcutaneous tissue 84 Internal passageways, work spaces, target spaces 100 Catheters 102 Expander 104 Port 110 Devices 112 Cabinet 132 needles 133 Internal passage 134 Wire advance mechanism 150 Needle attachment part 150a, 150b Needle attachment parts 151 Cut line 152 Guideway 154 Vacuum passage 160 Intersection 170 Loop guide 172 Input end, distal end 174 Output end, proximal end 176, 178 Mounting part 180 Installation Area 181 Slots 201 Extension area 210 Devices 212 Case 218 Sliding part 234 Wire advance mechanism 270 Loop Guide 310 Devices 312 Case 318 Sliding part 330, 332 Rack gear 331 Wire holding structure 340 Pinion Gear 500 Double Needle 502, 504 Needle part, needle passage 510 Tip 512 Aperture 650 Needle attachment part 652 Wire guide passage 654 Vacuum passage

Claims

1. A device for interacting with the syringe body and plunger to deliver the wire into the tissue working space, comprising: a needle configured to couple to the syringe body and having at least one aperture for guiding the proximal end of the wire into the tissue working space; a housing configured to couple with the syringe body and having at least one portion for engagement by a user; a slider configured to couple with the syringe plunger for movement therewith between a forward position and a retracted position, the slider including at least one portion for engagement by a user; Equipped with The device, wherein the slider is releasably coupled to the distal end of the wire to move the distal end of the wire and advance the proximal end of the wire forward within the needle when the slider and the syringe plunger move from the forward position toward 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 for moving the distal end of the wire with the syringe plunger.

3. 10. The device of claim 1, further comprising a wire advancement mechanism for translating the movement of the wire distal end to advance the proximal end of the wire forward within the needle as the slider and syringe plunger move from the forward position toward the retracted position.

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

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

6. 10. The device of claim 1, further comprising a needle mounting portion including a guide passageway coupled to the at least one needle hole for directing movement of the wire within the needle, and a vacuum passageway for coupling to the syringe body for creating a negative pressure in the at least one needle hole as the syringe plunger moves toward the retracted position.

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

8. The device of claim 6 , wherein the guide passage is positioned in alignment with the at least one bore of the needle for movement of the wire within the needle.

9. 7. The device of claim 6, wherein the needle includes two passages, a first of the needle passages being connected to the guide passage for guiding the proximal end of the wire, and a second of the needle passages being connected to the vacuum passage.

10. 2. The device of claim 1, wherein the wire advancement mechanism comprises a gear system that releasably couples the distal end of the wire to the slide such that movement of the slide and the syringe plunger from the forward position toward the retracted position moves the proximal end of the wire forward within the needle.

11. 1. A device for interacting with a syringe body and a plunger to deliver a catheter into a tissue working space, comprising: A wire, a catheter passed over the wire; a needle configured to couple to the syringe body and having at least one aperture for guiding the proximal end of the wire into the tissue working space; a housing configured to couple with the syringe body and having at least one portion for engagement by a user to releasably secure the catheter; and a slider configured to couple with the syringe plunger for movement therewith between a forward position and a retracted position, the slider including at least one portion for engagement by a user; Equipped with the slider is releasably coupled to the distal end of the wire to move the distal end of the wire and advance the proximal end of the wire forward through the catheter and needle and into a working space when the slider and the syringe plunger move from the forward position toward the retracted position; The device, wherein the catheter is configured to be released from the housing and slid along the wire into the working space.

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

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

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

15. The device of claim 11 , further comprising a dilator that is passed over the needle with the catheter.

16. 12. The device of claim 11, further comprising a needle mounting portion including a guide passageway coupled with the at least one needle hole for directing movement of the wire within the needle, and a vacuum passageway for coupling with the syringe body for creating a negative pressure in the at least one needle hole as the syringe plunger moves toward the retracted position.

17. The device of claim 11 , wherein the needle and needle mounting can be broken away from the wire in order for the catheter to slide along the wire into the working space.

18. The device of claim 16 , wherein the guide passage is positioned in alignment with the at least one bore of the needle for movement of the wire within the needle.

19. 17. The device of claim 16, wherein the needle includes two passages, a first of the needle passages being coupled to the guide passage for guiding the proximal end of the wire, and a second of the needle passages being coupled to the vacuum passage.

20. 14. The device of claim 13, wherein the wire advancement mechanism has an output end positioned rearwardly of the catheter so that a wire can exit the output end of the wire advancement mechanism and enter the catheter.

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