Multi-destination delivery needle

Abstract

A needle for accessing the vasculature of a patient is disclosed. The cannula includes a fluid lumen extending from a distal end to a proximal end and a guideway lumen extending proximally away from the distal end. The guideway lumen is configured such that a guidewire is disposed within the guideway lumen. A guideway slot extends radially through the guideway lumen wall and along the guideway lumen to the distal end. A sheath is disclosed covering the cannula. The sheath includes a separable portion through which the guidewire passes laterally. Also disclosed is a collar rotatably positionable between a guidewire secured position and a guidewire released position.

Description

TECHNICAL FIELD

[0001] The present invention relates to a needle for accessing the vasculature of a patient.

BACKGROUND ART

[0002] Various intravascular devices, including guidewires, catheters, vascular snares, or other percutaneous instruments, are inserted into a patient's vasculature to detect and / or treat various health problems. Placement of percutaneous instruments within the vasculature typically requires several steps. These steps may generally include accessing the blood vessel through the skin by puncturing the skin and inserting the tip of the needle into the blood vessel. A typical procedure may include establishing and maintaining negative pressure within the needle during the needle insertion process to prevent introduction of foreign objects into the patient including the blood vessel. Accordingly, a syringe is typically coupled with the needle to provide negative pressure. After the tip of the needle is inserted into the blood vessel, the clinician can draw blood from the blood vessel into the syringe (commonly referred to as a drawing flash) to confirm that the needle tip is within the blood vessel. Thereafter, the syringe is disconnected from the hub of the needle. The clinician can then insert a guidewire or other percutaneous instrument through the needle cannula into the blood vessel. The percutaneous instrument is inserted into the blood vessel, and the needle is removed from the instrument by sliding the needle off the proximal end of the instrument.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0003] The typical vascular access process described above presents several peculiar problems. For example, care must be taken to ensure that the needle tip remains within the blood vessel until the guidewire is inserted through the needle into the vessel. Maintaining the needle tip within the blood vessel while detaching the syringe from the needle can be difficult for clinicians, especially if the vessel is small. Therefore, clinicians may inadvertently move the needle tip out of the blood vessel. Furthermore, once the syringe is detached from the needle, it is impossible for clinicians to reconfirm that the needle tip remains within the blood vessel.

[0004] During the process of accessing vascular structures, the needle cannula serves two purposes: as described above, the cannula (1) defines fluid access to the blood vessel and (2) defines a guided passage for the instrument. However, since the needle contains a single cannula, both purposes may not be fulfilled simultaneously. In other words, when the needle is coupled to a syringe, the cannula cannot be used as an instrument passage, and when the instrument is inserted through the cannula, the needle cannot be used as fluid access.

[0005] Furthermore, current vascular access processes complicate or restrict the design of percutaneous devices. For example, devices must be adapted to detach the needle from the device by moving the proximal end of the device through a cannula.

[0006] This specification discloses novel devices, systems, and methods for accessing a patient's vascular structure and for improving the safety and practicality of placing percutaneous devices within the patient's vascular structure. [Means for solving the problem]

[0007] This specification discloses a needle for accessing a patient's vascular structure. The needle comprises a sharp tip at its distal end and a connecting hub at its proximal end, the hub being configured to connect to a syringe. The needle further comprises a cannula extending from its distal end to its proximal end. The cannula comprises a fluid lumen extending from its distal end to its proximal end and a guideway lumen extending proximally away from the distal end. The guideway lumen is configured such that a guidewire is positioned within it, and the guideway lumen comprises a guideway slot extending along the length of the guideway lumen, the guideway slot extending radially through the guideway lumen wall and along the guideway lumen to the distal end. The width of the guideway slot may be approximately equal to or less than the diameter of the guideway lumen.

[0008] The needle may further comprise a sheath positioned on the cannula along the length of the cannula extending away from the distal end, the sheath configured to hold the guidewire within the guideway lumen. The sheath may comprise a sheath wall having a separable portion extending from the distal end to the proximal end of the sheath. The sheath may be rotatable around the cannula between a first angular position and a second angular position. In the first position, the separable portion is positioned adjacent to the guideway slot, and in the second position, the separable portion is positioned away from the guideway slot. In some embodiments, the separable portion is configured for the guidewire to pass through, and in some embodiments, the separable portion is configured for the cannula to pass through. The separable portion may comprise a slit.

[0009] In some embodiments, the guideway lumen wall includes a deflectable portion that extends at least partially across the guideway slot. The deflectable portion is configured to hold the guidewire within the guideway slot when the deflectable portion is in a non-deflected state, and to allow the guidewire to pass out of the guideway slot when the deflectable portion is in a deflected state.

[0010] In some embodiments, the fluid lumen comprises a fluid lumen slot extending radially through the fluid lumen wall, the fluid lumen slot extending along the length of the cannula away from the distal end, and the width of the fluid lumen slot being approximately equal to or less than the diameter of the guideway lumen. The guideway lumen wall extends across the fluid lumen slot and defines a portion of the fluid lumen wall. The guideway lumen wall and the fluid lumen wall may be formed of different materials, and the guideway lumen wall may be more flexible than the fluid lumen wall. In some embodiments, the fluid lumen has a non-circular cross-section.

[0011] In some embodiments, the guideway slot comprises a first slot portion having a first slot width and a second slot portion having a second slot width, wherein the second slot width is greater than the first slot width. The first slot portion may be positioned distal to the second slot portion, and the first slot portion may extend distally to the distal end of the needle. The first slot width may be less than the diameter of the guidewire, and the second slot width may be greater than the diameter of the guidewire.

[0012] In some embodiments, the cannula has a non-circular cross-section, and in some embodiments, the cannula has an oval or triangular cross-section. In some embodiments, the needle comprises a collar coupled to a cannula, the cannula positioned within an opening in the collar, the opening extending from the distal end to the proximal end of the collar, and the collar preventing the guidewire from moving laterally out of the guidewire lumen. The collar may also comprise a collar slot extending radially outward from the opening to the outer surface of the collar, the collar slot extending from the distal end to the proximal end of the collar, and the collar slot is configured to allow the guidewire to pass laterally through the collar slot.

[0013] The collar may be rotatably positioned on the cannula in a guidewire release position where the collar slot aligns with the guideway slot. When the collar is in the release position, the guidewire can be removed laterally from the guideway lumen, and when the collar is rotated away from the release position, lateral removal of the guidewire from the guideway lumen is prevented. The collar may also be rotatably positioned on the cannula in a guidewire fixed position, so that when the collar is in the guidewire fixed position, longitudinal movement of the guidewire within the guideway lumen is prevented, and when the collar is rotated away from the guidewire fixed position, longitudinal movement of the guidewire within the guideway lumen is permitted. In some embodiments, when the collar is in the guidewire fixed position, rotation of the guidewire relative to the needle is prevented, and when the collar is rotated away from the guidewire fixed position, rotation of the guidewire relative to the needle is permitted. The collar may be positioned on the cannula such that the second slot portion is located between the distal end and the proximal end of the collar. The collar may also be coupled to the sheath so as to define co-rotation with the sheath.

[0014] This specification also discloses a system for accessing a patient's vascular structure, the system comprising a needle and a guidewire. The needle comprises a sharp tip at its distal end and a connecting hub at its proximal end, the hub configured to connect to a syringe. The needle further comprises a cannula extending from its distal end to its proximal end. The cannula comprises a fluid lumen extending from its distal end to its proximal end and a guideway lumen extending proximally away from the distal end. The guideway lumen is configured such that a guidewire is positioned within it, and the guideway lumen comprises a guideway slot extending along the length of the guideway lumen. The guidewire is positioned within the guideway lumen. The system may further comprise a syringe coupled to the needle.

[0015] In some embodiments of the system, the needle further comprises a sheath positioned on the cannula along the length of the cannula extending away from the distal end, the sheath being configured to hold the guidewire within the guideway lumen. The sheath has a sheath wall having a separable portion extending from the distal end to the proximal end, the separable portion being configured for the guidewire to pass through. The sheath may be rotatable around the cannula between a first angular position and a second angular position, the separable portion being positioned adjacent to the guideway slot in the first position and away from the guideway slot in the second position.

[0016] In some embodiments of the system, the guideway lumen wall comprises a deflectable portion that extends at least partially across the guideway slot, the deflectable portion being configured to hold the guidewire within the guideway slot when the deflectable portion is in a non-deflected state, and the deflectable portion being configured to allow the guidewire to pass out of the guideway slot when the deflectable portion is in a deflected state.

[0017] The guideway slot comprises a first slot portion having a first slot width and a second slot portion having a second slot width, wherein the second slot width is greater than the first slot width. The first slot width can be smaller than the diameter of the guide wire, and the second slot width can be larger than the diameter of the guide wire.

[0018] In some embodiments of the system, the guide wire comprises a first diameter portion having a first diameter and a second diameter portion having a second diameter, wherein the first diameter is greater than the first slot width and the second diameter is less than the first slot width.

[0019] In some embodiments of the system, the needle further comprises a collar coupled to a cannula, the cannula positioned within an opening in the collar, and the collar prevents the guidewire from moving laterally out of the guideway lumen. The opening extends from the distal end to the proximal end of the collar. The collar comprises a collar slot extending radially outward from the opening to the outer surface of the collar, the collar slot extending from the distal end to the proximal end of the collar. The collar slot is configured to allow the guidewire to pass laterally through it.

[0020] In some embodiments of the system, the collar is rotatably positioned on the cannula in a guidewire release position where the collar slot aligns with the guideway slot, so that when the collar is in the guidewire release position, the guidewire can be removed laterally from the guideway lumen, and when the collar is rotated away from the release position, the guidewire cannot be removed laterally from the guideway lumen.

[0021] The collar may also be rotatably positioned on the cannula at the guidewire fixation position, so that when the collar is in the guidewire fixation position, the guidewire is prevented from moving longitudinally within the guideway lumen, and when the collar is rotated away from the guidewire fixation position, the guidewire is allowed to move longitudinally within the guideway lumen. When the collar is in the guidewire fixation position, rotation of the guidewire relative to the needle may also be prevented, and when the collar is rotated away from the guidewire fixation position, rotation of the guidewire relative to the needle may be allowed.

[0022] This specification also discloses a method for positioning a guidewire within a patient's vascular structure. This method includes the steps of: inserting a needle through the patient's skin such that the tip of the needle is positioned within a blood vessel; drawing blood from the blood vessel into a syringe coupled to the needle through the fluid lumen of the needle; advancing the guidewire along the blood vessel through the guideway lumen of the needle; and separating the guidewire laterally from the needle through a slot extending along the guideway lumen. The separation step may be performed while the syringe remains coupled to the needle.

[0023] The method may further include the step of positioning the guidewire in the guideway lumen such that the distal tip of the guidewire is positioned close to the tip of the needle, and the positioning step may be performed before the insertion step.

[0024] The method may further include, before the insertion step, rotating the needle collar to the guidewire fixing position to prevent the guidewire from moving longitudinally within the guideway lumen during the insertion step. The method may further include, before the advancement step, rotating the collar away from the fixing position.

[0025] In some embodiments of the method, the separating step includes moving the guidewire laterally through the separable portion of the sheath disposed on the cannula. In other embodiments, the separating step includes moving the reduced-diameter portion of the guidewire longitudinally through the slot.

[0026] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which illustrate specific embodiments of such concepts in greater detail. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] A more detailed description of the present disclosure will be made by referring to specific embodiments of the present disclosure illustrated in the accompanying drawings. It is understood that these drawings only show typical embodiments of the present invention and therefore shall not be regarded as limiting the scope of the present invention. The exemplary embodiments of the present invention will be described and explained in further specificity and detail with reference to the accompanying drawings. [Figure 1A] A diagram illustrating a vasculature access system according to some embodiments. [Figure 1B] A detailed perspective view of the distal portion of the needle of Figure 1A, according to some embodiments. [Figure 1C] A detailed perspective view similar to Figure 1B, further showing the sheath according to some embodiments. [Figure 1D] A detailed perspective view similar to Figure 1C, further showing the separable portion of the sheath according to some embodiments. [Figure 2A] A detailed perspective view of the distal portion of another embodiment of a needle according to some embodiments. [Figure 2B] A detailed perspective view of the distal portion of another embodiment of the needle of Figure 2A having a flexible wall portion, according to some embodiments. [Figure 2C] A detailed perspective view of the distal portion of another embodiment of the needle of Figure 2A having a sheath, according to some embodiments. [Figure 3]Detailed perspective view of the distal portion of another embodiment of a needle having a guideway lumen positioned within a fluid lumen, according to several embodiments. [Figure 4] Detailed perspective view of the distal portion of another embodiment of a needle having a septum defining a fluid lumen and a guideway lumen within the cannula wall, according to several embodiments. [Figure 5] Detailed perspective view of the distal portion of another embodiment of a needle having a guideway lumen with a flexible wall, according to several embodiments. [Figure 6A] Detailed perspective view of the distal portion of another embodiment of a needle having an oval shape, according to several embodiments. [Figure 6B] End view of the needle in Figure 6A, according to several embodiments. [Figure 7A] Detailed perspective view of the distal portion of another embodiment of a needle having a triangle, according to several embodiments. [Figure 7B] End view of the needle in Figure 7A, according to several embodiments. [Figure 8A] Detailed perspective view of the proximal portion of another embodiment of a needle having a slot with an expanded portion, according to several embodiments. [Figure 8B] A detailed perspective view of the proximal portion of the needle in Figure 8A illustrating a guide wire positioned within a slot according to several embodiments. [Figure 9A] Detailed perspective view of the proximal portion of another embodiment of a needle having a rotatable collar coupled to the needle, according to several embodiments. [Figure 9B] A posterior perspective view of the proximal portion of the needle in Figure 9A, according to several embodiments. [Figure 9C] Front view of the proximal portion of the needle in Figure 9A, in which the collar is rotated to the guidewire fixing position, according to several embodiments. [Figure 9D] Cross-sectional view of the proximal portion of the needle in Figure 9A, cut along the dividing line 9D-9D in Figure 9C, according to several embodiments. [Figure 9E] Front view of the proximal portion of the needle in Figure 9A, in which the collar is rotated to the open position, according to several embodiments. [Figure 9F]Cross-sectional view of the proximal portion of the needle in Figure 9A, cut along the dividing line 9F-9F in Figure 9E, according to several embodiments. [Figure 9G] Perspective view of the needle of Figure 9A, including the sheath, according to several embodiments. [Figure 10A] A diagram illustrating another embodiment of a vascular structure access system according to several embodiments. [Figure 10B] Detailed perspective views of the distal portion of the needle in Figure 10A, according to several embodiments. [Figure 10C] A perspective view of the proximal portion of the needle in Figure 10A, showing a guidewire inserted through the expanded portion of the slot according to several embodiments. [Figure 10D] A perspective view of the proximal portion of the system in Figure 10A, which shows a guide wire having a reduced diameter portion according to several embodiments. [Modes for carrying out the invention]

[0028] Before disclosing some specific embodiments in more detail, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that certain embodiments disclosed herein may be easily decoupled from their specific embodiments and may have features that can be optionally combined with or substituted for features of any of the other embodiments disclosed herein.

[0029] Regarding the terminology used herein, it should be understood that each term is intended to describe a particular embodiment and does not limit the scope of the concepts presented herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify features or processes that are different from each other within a group of features or processes, and do not impose any orderly or numerical limitations. For example, the "1st," "2nd," and "3rd" features or processes do not necessarily have to appear in this order, and a particular embodiment containing such features or processes does not necessarily have to be limited to three features or processes. Notations such as "left," "right," "up," "down," "front," and "back" are used for convenience and do not, for example, imply any particular fixed position, orientation, or direction. Rather, such notations are used to indicate, for example, relative position, orientation, or direction. Unless it is clearly indicated in the context that otherwise, singular forms represented by "a," "an," and "the" include plural forms.

[0030] The directional terms “proximal” and “distal” are used herein to refer to opposing positions in a medical device. The proximal end of the device is defined as the end of the device that is closest to the end user and furthest from the patient when the device is used by the end user. The distal end is the end of the device opposite the proximal end along its longitudinal direction, or the end that is furthest from the end user and closer to the patient.

[0031] The phrases "to be connected to" and "to be coupled to" refer to any form of interaction between two or more entities, including mechanical and fluid interactions. Two components can be connected or coupled to each other even if they are not in direct contact with each other. For example, two components can be coupled to each other via an intermediate component.

[0032] Any method disclosed herein includes one or more steps or actions for carrying out the described method. The method steps and / or actions are interchangeable. In other words, the order and / or use of any particular steps and / or actions may be changed unless a particular order of steps or actions is required for the proper operation of the embodiment. Furthermore, only a subroutine or part of a method described herein may constitute an independent method within the scope of this disclosure. In other words, some methods may include only a portion of the steps described in a more detailed method.

[0033] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art. Figure 1A illustrates a vascular structure access system 10 including a needle 100, a syringe 20, and a guidewire 30. The needle 100 may be used to provide access for the guidewire 30 within a blood vessel 15. The needle 100 is coupled to the syringe 20 by a hub 115 located at the proximal end 102 of the needle 100, and the needle 100 has a sharp tip 113 at its distal end 101. The needle 100 includes a cannula 110 extending from the proximal end 112 adjacent to the hub 115 to the tip 113. The cannula 110 may be made of any hard material such as stainless steel or hard plastic. As will be further described below, the needle 100 includes a fluid lumen that defines a fluid communication between the syringe 20 and the blood vessel 15.

[0034] During use, the clinician inserts the tip 113 of the needle 100 into the blood vessel 15 through the skin. In some cases, the clinician may draw blood from the blood vessel 15 by pulling the plunger 21 of the syringe 20 to confirm a visual "blood flush" that the tip 113 is inside the blood vessel 15. The blood flush may be visible in the syringe 20, along the cannula 110 if the cannula 110 is translucent / transparent, or in some other chamber. In other cases, the blood flush may include blood dripping from the needle hub 115 when the syringe 20 is detached from the hub 115. After confirming that the tip 113 is inside the blood vessel 15, the clinician may move the guidewire distally into the blood vessel.

[0035] Figures 1B to 1D illustrate detailed perspective views of the distal portion of the needle 100, showing additional details, components, and features of the needle 100. As shown in Figure 1B, the cannula 110 includes a fluid lumen 120 having an open end adjacent to the tip 113. The fluid lumen 120 extends from the tip 113 at the distal end 101 to the hub 115 at the proximal end 102, defining a fluid passage along the entire length of the needle 100. The hub 115 facilitates the physical attachment of the needle 100 to the syringe 20 and establishes a fluid connection between the fluid lumen 120 and the syringe 20.

[0036] The cannula 110 further comprises a guideway lumen 130 extending along the length of the cannula 110 from its tip 113 to its proximal end 112. The guideway lumen 130 is sized to accommodate the placement of the guidewire 30 into the guideway lumen 130. The cannula 110 comprises a slot 135 extending longitudinally along the length of the guideway lumen 130. The slot 135 extends radially through the guideway lumen wall 131 and defines a slot width 135A. The slot width 135A may be sized to accommodate the lateral passage of the guidewire 30 through the slot 135 in and out of the guideway lumen 130. In some embodiments, the slot width 135A may be approximately equal to the diameter of the guideway lumen 130. In other embodiments, the slot width 135A may be smaller than the diameter of the guideway lumen 130. As shown, when in use, the guidewire 30 may be positioned in the guideway lumen 130 such that the distal end 31 of the guidewire 30 is positioned close to the tip 113.

[0037] In the illustrated embodiment shown in Figure 1C, the needle 100 may comprise an elongated sheath 140 positioned around the cannula 110. The sheath 140 may be sized to restrain the guidewire 30 within the guideway lumen 130. More specifically, the sheath 140 may prevent the guidewire 30 from moving laterally out of the guideway lumen 130. In some embodiments, the sheath 140 may be slidably coupled to the cannula 110 so that the sheath 140 can slide and / or rotate longitudinally relative to the cannula 130. The sheath 140 may be sized and positioned on the cannula 130 such that a sharp tip 113 extends distally beyond the distal end of the sheath 140. Although not shown, the guideway lumen 130 extends proximal beyond the proximal end of the sheath 140. Sheath 140 can be made from medical-grade plastic materials such as polypropylene, polyethylene, polytetrafluoroethylene (PTFE), or other materials suitable for forming a thin tubular sheath.

[0038] Figure 1D is a detailed perspective view similar to Figure 1C, showing a separable portion 141 of the sheath 140 that may extend along the entire length of the sheath 140. The separable portion 141 may be a slit or a longitudinal portion of a weakened sheath structure, such as a thin-walled section or perforation. When in use, the separable portion 141 may facilitate the lateral removal of the guidewire 30 from the guideway lumen 130 by a deliberate guidewire removal action by a clinician. The separable portion 141 may also facilitate the retention of the guidewire 30 within the guideway lumen 130 when a deliberate guidewire removal action by a clinician is not performed. In some embodiments, a deliberate guidewire removal action may involve pulling the guidewire with sufficient tensile force to cause separation of the separable portion 141, thereby allowing the guidewire 30 to be removed laterally from the guideway lumen 130. In some embodiments, the separable portion 141 may also facilitate the lateral removal of the sheath 140 from the cannula 110.

[0039] In some embodiments, the separable portion 141 may be a slit having a width greater than the diameter of the guidewire 30. In such embodiments, the sheath 140 can hold the guidewire 30 within the guideway lumen 130 when the sheath 140 is rotatably positioned such that the separable portion 141 is positioned away from the slot 135. In this embodiment, an intentional guidewire removal operation may involve rotating the sheath 140 to align the separable portion 141 with the slot 135, thereby facilitating the lateral removal of the guidewire 30 from the guideway lumen 130.

[0040] Figures 2A–2C illustrate embodiments of needle 200 that may be similar in certain respects to components of needle 100 described in relation to Figures 1A–1D. It will be understood that all the embodiments illustrated may have similar features. Therefore, similar features are indicated by similar reference numbers, with the leading digit incremented to "2". For example, a cannula is indicated as "110" in Figures 1A–1D, and a similar cannula is indicated as "210" in Figures 2A–2C. Accordingly, relevant disclosures described above with respect to similarly identified features may not be repeated hereafter. Furthermore, certain features of needle 100 and related components shown in Figures 1A–1D may not be shown in the drawings, not identified by reference numbers, or not specifically discussed in the following description. However, such features may be clearly identical or substantially identical to features shown in other embodiments and / or features described in relation to such embodiments. Therefore, relevant descriptions of such features apply equally to the features of the needle in Figures 2A–2C. Any suitable combination of features and variations of features described with respect to the needle 100 and components illustrated in Figures 1A to 1D can be used in conjunction with the needle and components of Figures 2A to 2C, and vice versa. The patterns of this disclosure are equally applicable to further embodiments shown in subsequent figures and described later.

[0041] Figures 2A and 2C are detailed perspective views of the distal portion of the needle 200, showing its details, components, and features. The needle 200 comprises a cannula 210 having a cannula wall 211. As shown in Figures 1A and 1B, the cannula 210 comprises a fluid lumen 220 having an open end adjacent to the tip 213. The fluid lumen 220 extends from the tip 213 to the hub (not shown, see Figure 1A) at the proximal end, defining a fluid passage along the entire length of the needle 200. The fluid lumen 220 is defined by a fluid lumen wall 221 that forms around the fluid lumen 220. Thus, the fluid lumen wall 221 can define a separate fluid conduit located inside the cannula, which is defined by the cannula wall 211.

[0042] The cannula wall 211 and the fluid lumen wall 221 combine to define a guideway lumen 230 that extends along the length of the cannula 210 from the tip 213 to the proximal end of the cannula 210. The guideway lumen 230 is sized to accommodate the placement of the guidewire 30 into the guideway lumen 230. The cannula 210 has a longitudinal slot 235 that extends along the length of the cannula 210 from the distal tip 213 to the hub. The slot 235 extends radially through the cannula wall 211 and defines a slot width 235A. The slot width 235A can be sized to accommodate the lateral passage of the guidewire 30 in and out of the guideway lumen 230. As shown, in use, the guidewire 30 can be positioned in the guideway lumen 230 such that the distal end 31 of the guidewire 30 is positioned close to the tip 213.

[0043] As shown in Figure 2B, the cannula wall 211 may have one or more flexible extensions 211A. The flexible extensions 211A extend partially across the slot 235, defining a reduced slot width 235B. The reduced slot width 235B can be smaller than the diameter of the guidewire 30, so that the flexible extensions 211A can facilitate the retention of the guidewire 30 within the guideway lumen 230. The flexible extensions 211A can also facilitate the lateral removal of the guidewire 30 from the guideway lumen 230 by a clinician's intentional guidewire removal action.

[0044] In some embodiments, the cannula 210 may be made of metal, plastic, or other suitable material, and the flexible extension 211A may be an extended portion of the cannula wall 211. In other embodiments, the flexible extension 211A may be a separate component attached to the cannula 210. In such embodiments, the flexible extension 211A may be formed of any appropriately flexible material such as an elastomer or soft plastic, including silicone, ethylene propylene diene monomer (EPDM), rubber, etc.

[0045] In the illustrated embodiment shown in Figure 2C, the needle 100 may comprise a long sheath 240 positioned around the cannula 210. The sheath 240 may be sized to restrain the guidewire 30 within the guideway lumen 230. More specifically, the sheath 140 may prevent the guidewire 30 from moving laterally out of the guideway lumen 230. In some embodiments, the sheath 240 may be slidably coupled to the cannula 210 so that the sheath 240 can slide and / or rotate longitudinally relative to the cannula 210. The sheath 240 may be sized and positioned on the cannula 230 such that a sharp tip 213 extends distally beyond the distal end of the sheath 240. Although not shown, the guideway lumen 230 extends proximal beyond the proximal end of the sheath 240.

[0046] The sheath 240 may include a separable portion 241 that may extend along the entire length of the sheath 240. The separable portion 241 may be, for example, a slit or a longitudinal portion of a weakening structure such as a thin-walled section or a perforation. When in use, the separable portion 241 may facilitate the lateral removal of the guidewire 30 from the guideway lumen 230 by a deliberate guidewire removal action by a clinician. The separable portion 241 may also facilitate the retention of the guidewire 30 within the guideway lumen 230 when no deliberate action is performed by a clinician. In some embodiments, the deliberate action may include pulling the guidewire with sufficient tensile force to cause separation of the separable portion 241, thereby allowing the guidewire 30 to be removed laterally from the guideway lumen 230. In some embodiments, the separable portion 241 may also facilitate the lateral removal of the sheath 240 from the cannula 210.

[0047] In some embodiments, the separable portion 241 may be a slit having a width greater than the diameter of the guidewire 30. In such embodiments, the sheath 240 can hold the guidewire 30 within the guideway lumen 230 when the sheath 140 is rotatably oriented such that the separable portion 241 is positioned away from the slot 235. In this embodiment, intentional action may include rotating the sheath 240 to align the separable portion 241 with the slot 235, thereby facilitating the lateral removal of the guidewire 30 from the guideway lumen 230.

[0048] Figure 3 is a detailed perspective view of the distal portion of the needle 300. The needle 300 comprises a cannula 310 having a cannula wall 311, the cannula wall 311 defining the interior of the cannula 310. A guideway lumen 330, having a guideway lumen wall 331, is located inside the cannula 310 and extends along the length of the cannula 310 from the tip 313 to the proximal end of the cannula 310. The cannula wall 311 and the guideway lumen wall 331 combine to define a fluid lumen 320. The cannula wall 311 and the guideway lumen wall 331 are sealed together to form a closed circumferential wall of the fluid lumen 320. The fluid lumen 320 extends from the tip 313 to the hub (not shown, see Figure 1A) at the proximal end and defines a fluid passage along the entire length of the needle 300. As shown, the fluid lumen 320 extends at least partially around the guideway lumen 330.

[0049] The guideway lumen 330 is dimensioned to accommodate the placement of the guidewire 30 into the guideway lumen 330. The cannula wall 311 and the guideway lumen wall 331 are provided with a longitudinal slot 335 that extends along the length of the cannula 310 from the distal tip 313 to the hub. The slot 335 extends radially through the guideway lumen wall 331 and the cannula wall 311, defining a slot width 335A. The slot width 335A can be dimensioned to accommodate the lateral passage of the guidewire 30 in and out of the guideway lumen 330. As shown, in use, the guidewire 30 can be positioned in the guideway lumen 330 such that the distal end 31 of the guidewire 30 is positioned close to the tip 313.

[0050] Figure 4 is a detailed front perspective view of the distal portion of the needle 400. The needle 400 comprises a cannula 410 having a cannula wall 411, the cannula wall 411 defining the interior of the cannula 410. Within this interior is a septum 450 attached to the cannula wall 411. The septum 450 may be formed of a flexible material such as silicone, ethylene propylene diene monomer (EPDM), rubber, or soft plastic. The septum 450 and the cannula wall 411 combine to define a fluid lumen 420. More specifically, the septum 450 and the cannula wall 411 combine to form a circumferential fluid lumen wall 421. The fluid lumen 420 extends from the tip 411 to the hub (not shown, see Figure 1A) at the proximal end, defining a fluid passage along the entire length of the needle 400.

[0051] The septum 450 forms a guideway lumen 430, which includes a guideway lumen wall 431. The guideway lumen 430 extends along the length of the cannula 410, from the tip 413 to the proximal end of the cannula 410. The guideway lumen 430 is sized to accommodate the placement of the guidewire 30 into the guideway lumen 430. The cannula wall 411 includes a longitudinal cannula slot 435 that extends along the length of the cannula 410, from the distal tip 413 to the hub. The cannula slot 435 extends radially through the cannula wall 411 and defines a slot width 435A. The slot width 435A can be sized to accommodate the lateral passage of the guidewire 30 in and out of the guideway lumen 430. As shown, when in use, the guidewire 30 may be positioned in the guideway lumen 430 such that the distal end 31 of the guidewire 30 is positioned close to the tip 413.

[0052] The septum 450 extends into the cannula slot 435 and may define one or more flexible extensions 450A of the septum 450. The flexible extensions 450A extend partially across the cannula slot 435 and define a reduced slot width 435B. The reduced slot width 435B can be smaller than the diameter of the guidewire 30, so that the flexible extensions 450A can facilitate the retention of the guidewire 30 within the guideway lumen 430. The flexible extensions 450A can also facilitate the lateral removal of the guidewire 30 from the guideway lumen 430 by a clinician's intentional guidewire removal action.

[0053] Figure 5 is a detailed front perspective view of the distal portion of the needle 500. The needle 500 comprises a cannula 510 having a cannula wall 511, the cannula wall 511 defining the interior of the cannula 510. Within this interior, at least partially, is a septum 550 attached to the inner surface of the cannula wall 511. In some embodiments, a portion of the septum 550 may be attached to the outer surface of the cannula wall 511. The septum 550 may be formed from a flexible material such as silicone, ethylene propylene diene monomer (EPDM), rubber, or soft plastic. The septum 550 and the cannula wall 511 combine to define a fluid lumen 520. More specifically, the septum 550 and the cannula wall 511 combine to form a circumferential fluid lumen wall 521. The fluid lumen 520 extends from the tip 513 to the hub (not shown, see Figure 1A) at the proximal end, defining a fluid passage along the entire length of the needle 500.

[0054] The septum 550 forms a guideway lumen 530, which includes a guideway lumen wall 531. The guideway lumen 530 extends along the length of the cannula 510, from the tip 511 to the proximal end of the cannula 510. The guideway lumen 530 is sized to accommodate the placement of the guidewire 30 into the guideway lumen 530. The cannula wall 511 includes a longitudinal slot 535 that extends along the length of the cannula 510, from the distal tip 511 to the hub. The cannula slot 535 extends radially through the cannula wall 511 and defines a slot width 535A. The slot width 535A can be sized to accommodate the lateral passage of the guidewire 30 in and out of the guideway lumen 530. As shown, when in use, the guidewire 30 may be positioned in the guideway lumen 530 such that the distal end 31 of the guidewire 30 is positioned close to the tip 511.

[0055] The septum 550 may extend into the cannula slot 535. The septum 550 includes a slit 555 that extends longitudinally along the septum 550. The slit 555 is positioned in alignment with the slot 535. The slit 555 extends radially through the guideway lumen wall 531 to define one or more flexible extensions 550A of the septum 550. The flexible extensions 550A result in the retention of the guidewire 30 within the guideway lumen 530 unless a deliberate guidewire removal action is performed by the clinician. The flexible extensions 550A can also facilitate the lateral removal of the guidewire 30 from the guideway lumen 530 by a deliberate guidewire removal action by the clinician. In other words, the clinician can pull the guidewire 30 through the slit 555.

[0056] Figures 6A and 6B illustrate the needle 600. Figure 6A is a detailed perspective view of the distal portion of the needle 600, and Figure 6B is an end view of the distal portion of Figure 6A. The needle 600 comprises an oval-shaped cannula 610 that defines a fluid lumen 620 having a fluid lumen wall 621 and a guideway lumen 630 having a guideway lumen wall 631. The fluid lumen 620 and the guideway lumen 630 are arranged in parallel to define the oval shape. The fluid lumen 620 extends from the tip 613 to the hub (not shown, see Figure 1A) at the proximal end, defining a fluid passage along the entire length of the needle 600.

[0057] The guideway lumen 630 extends along the length of the cannula 610 from the tip 613 to the proximal end of the cannula 610. The guideway lumen 630 is sized to accommodate the placement of the guidewire 30 into the guideway lumen 630. The guideway lumen wall 631 has a longitudinal slot 635 that extends along the length of the cannula 610 from the distal tip 613 to the hub. The cannula slot 635 extends radially through the guideway lumen wall 631 and defines a slot width 435A. As shown, when in use, the guidewire 30 can be positioned in the guideway lumen 630 such that the distal end 31 of the guidewire 30 is positioned close to the tip 613.

[0058] In the exemplary embodiment, the slot width 635A can be smaller than the diameter of the guidewire 30 so that the guidewire 30 is held within the guideway lumen 630. The guideway lumen wall 631 may include a deflectable portion 632 configured to deflect outward to increase the width 635A sufficiently to allow the guidewire 30 to pass laterally out of the guideway lumen 630. When in use, the deflectable portion 632 may facilitate holding the guidewire 30 within the guideway lumen 130 unless a deliberate guidewire removal action is performed by the clinician. The deflectable portion 632 may also facilitate the lateral removal of the guidewire 30 from the guideway lumen 630 by a deliberate guidewire removal action by the clinician, such as pulling the guidewire 30.

[0059] Figures 7A and 7B illustrate the needle 700. Figure 7A is a detailed perspective view of the distal portion of the needle 700, and Figure 7B is an end view of the distal portion of Figure 7A. The needle 700 comprises a triangular cannula 710 that defines a fluid lumen 720 having a fluid lumen wall 721 and a guideway lumen 730 having a guideway lumen wall 731. The fluid lumen 720 and the guideway lumen 730 are arranged in parallel. The guideway lumen 730 may have a circular cross-section, and the cross-section of the fluid lumen 720 may be defined by the triangular shape of the cannula 710. The fluid lumen 720 extends from the tip 713 to the hub (not shown, see Figure 1A) at the proximal end, defining a fluid passage along the entire length of the needle 700.

[0060] The guideway lumen 730 extends along the length of the cannula 710 from the tip 713 to the proximal end of the cannula 710. The guideway lumen 730 is sized to accommodate the placement of the guidewire 30 into the guideway lumen 730. The guideway lumen wall 731 has a longitudinal slot 735 that extends along the length of the cannula 710 from the distal tip 713 to the hub. The cannula slot 735 extends radially through the guideway lumen wall 731 and defines a slot width 735A. As shown, when in use, the guidewire 30 can be positioned in the guideway lumen 730 such that the distal end 31 of the guidewire 30 is positioned close to the tip 713.

[0061] In the exemplary embodiment, the slot width 735A can be smaller than the diameter of the guidewire 30 so that the guidewire 30 is held within the guideway lumen 730. The guideway lumen wall 731 may include one or more deflectable portions 732 configured to deflect outward to increase the width 735A sufficiently to allow the guidewire 30 to pass laterally out of the guideway lumen 730. When in use, the deflectable portions 732 may facilitate holding the guidewire 30 within the guideway lumen 730 unless a deliberate guidewire removal action is performed by the clinician. The deflectable portions 732 may also facilitate the lateral removal of the guidewire 30 from the guideway lumen 730 by a deliberate guidewire removal action by the clinician, such as pulling the guidewire 30.

[0062] Figure 8A is a detailed perspective view of the proximal portion of the needle 800. A cannula 810 is shown extending distally away from the hub 815. The cannula 810 comprises a guideway lumen 830 having a guideway lumen wall 831. The guideway lumen 830 extends along the length of the cannula 810 from the distal end to the proximal end 812 of the cannula 810. The guideway lumen 830 is sized to accommodate the placement of the guidewire 30 into the guideway lumen 830. The guideway lumen wall 831 comprises a longitudinal slot 835 extending along the length of the cannula 810 from the distal end to the hub 815. The slot 835 extends radially through the guideway lumen wall 831, defining a slot width 835A. The slot 835 comprises an expanded portion 836 defining an expanded slot width 835B.

[0063] Figure 8B illustrates a needle 800 having a guidewire 30 positioned within a slot 835. In the illustrated embodiment, the slot width 835A is smaller than the diameter of the guidewire 30 so that the guidewire 30 is held within the guideway lumen 830. Conversely, the expanded slot width 835B is larger than the diameter of the guidewire 30 so that the guidewire 30 can exit the guideway lumen 830 through the expanded portion 836. As shown, the expanded portion 836 may be positioned close to the proximal end 812 of the cannula 810.

[0064] Figures 9A to 9G illustrate another embodiment of the needle 900 according to several embodiments. Figure 9A is a perspective view of the proximal portion of the needle 900, which includes a rotatable collar 960 coupled to a cannula 910. As shown, the collar 960 may be positioned close to the hub 915. The collar 960 defines a distal end 961, a proximal end 962, and an outer surface 963. The collar 960 may include a handle 965 to facilitate the clinician rotating the collar 960 relative to the hub 915. The collar 960 includes a cylindrical opening 970 (i.e., a hole) extending through the collar 960 from the distal end 961 to the proximal end 962, through which the cannula 910 is inserted. The opening 970 is sized to provide rotational and / or sliding fit with the cannula 910, and is also sized to prevent the guidewire 30 from moving laterally out of the guideway lumen 930 through the guideway lumen slot 935.

[0065] The collar 960 is configured to rotate between a guidewire fixed position illustrated in Figures 9B–9D and a guidewire released position illustrated in Figures 9E–9F. Figure 9B is a rear perspective view of the proximal portion of the needle 900 showing the rear of the collar 960. The collar 960 includes a collar slot 975 extending radially outward from the opening 970 to the outer surface 963. The collar slot 975 also extends from the distal end 961 to the proximal end 962. As similarly shown, the guidewire 30 may be positioned within the passage 980 of the collar 960.

[0066] Figure 9C is a front view of the proximal portion of the needle 900. The minimum width 976 of the collar slot 975 is sized to be small enough to prevent the cannula 910 from moving laterally outward from the opening 970, and large enough to allow the guidewire 30 to move laterally outward from the opening 970.

[0067] Figure 9D is a cross-sectional view of the proximal portion of the needle in Figure 9A, cut along the dividing line 9D-9D in Figure 9C, illustrating a guidewire fixation mechanism for the needle 900 according to several embodiments. Figure 9D shows that the guidewire 30 is positioned within the guideway lumen 930 along the distal portion of the collar 970. It is also shown that the guidewire 30 exits (excitates) the guideway lumen 930 at the proximal end 932 of the guideway lumen 930. Figure 9D further shows that the guidewire 30 is positioned within a passage 980 along the proximal portion of the collar 970.

[0068] The guidewire fixing mechanism may include a cam surface 981 defined by a portion of the passage 980. The cam surface 981 is located close to the proximal end 932 of the guideway lumen 930 and defines a variable gap 985 between the cam surface 981 and the cannula 910. The cam surface 981 may be configured such that the gap 985 is reduced when the collar 960 is rotated toward the guidewire fixing position, and the gap 985 is increased when the collar 970 is rotated toward the guidewire release position. When the collar 960 is rotated toward the guidewire fixing position, the gap 985 may be reduced sufficiently to define a clamping force 982 on the guidewire 30. The clamping force 982 may be sufficient to prevent longitudinal movement and / or rotation of the guidewire 30 relative to the needle 900.

[0069] Figure 9E is a front view of the proximal portion of the needle 900, and Figure 9F is a cross-sectional view of the proximal portion of the needle 900 cut along the dividing line 9F-9F in Figure 9E with the collar 970 rotated to the guidewire release position. As shown in Figure 9E, when the collar 970 is rotated to the guidewire release position, the collar slot 975 aligns with the slot 935 of the guideway lumen 930. Thus, the collar slot 975 allows the guidewire 30 to be removed laterally from the guideway lumen 930 through the slot 935. As shown in Figure 9F, the guidewire 30 is removed from the passage 980. With the collar 970 rotated to the guidewire release position, the clinician can laterally separate the needle 900 from the guidewire 30. In other words, the clinician can separate the guidewire 30 from the needle 900 without removing the needle 900 from the proximal end of the guidewire 30.

[0070] In some embodiments, the guidewire 30 can be separated from the needle 900 by sliding the collar 970 distally away from the distal end of the cannula 910, and then passing the guidewire 30 laterally through the slot 935. In some embodiments, the collar 970 may be formed of a flexible material, or may have one or more flexible portions (e.g., hinge portions), so that the minimum width 976 of the slot 975 can be widened by deformation of the collar 970. In such embodiments, the minimum width 976 of the slot 975 may be increased to facilitate the lateral movement of the cannula 910 through the slot 975.

[0071] Figure 9G is a perspective view of the needle 900 with a sheath 940. The sheath 940 is positioned along the cannula 910 to restrain the guidewire 30 within the guideway lumen 930. The sheath 940 may also include a detachable portion 941 (hidden on the bottom side of the sheath 940 in Figure 9G) that extends along the length of the sheath 940. The sheath 940 may be coupled with the collar 970 such that it co-rotates with the collar 970, i.e., the sheath 940 rotates when the clinician rotates the collar 960. The sheath 940 may be coupled with the collar 970 such that the detachable portion 941 is angularly aligned with the collar slot 975. During use, the clinician can remove the guidewire 30 from the guideway lumen 930 by rotating the collar 960 to the guidewire release position and pulling the guidewire radially outward through the slot 935, the collar slot 975, and the detachable portion 941.

[0072] Figure 10A illustrates another embodiment of the vascular structure access system 1010, including a needle 1100, a syringe 1020, and a guidewire 1030. The needle 1100 is coupled to the syringe 1020 by a hub 1115 located at the proximal end 1102 of the needle 1100 and has a sharp tip 1113 at the distal end 1101. The needle 1100 includes a cannula 1110 extending from the proximal end 1112 to the tip 1113 of the cannula 1110 adjacent to the hub 1115. The cannula 1110 may be formed of any hard material such as stainless steel or hard plastic. The needle 1100 is used to provide access for the guidewire 1030 within the blood vessel 15. As will be further described below, the needle 1100 includes a fluid lumen that defines a fluid communication between the syringe 1020 and the blood vessel 15.

[0073] Figure 10B is a detailed perspective view of the distal portion of the needle 1100, showing additional details, components, and features of the needle 1100. As shown in Figure 10B, the cannula 1110 includes a fluid lumen 1120 having an open end adjacent to the tip 1113. The fluid lumen 1120 extends from the tip 1113 of the distal end 1101 to the hub 1115 of the proximal end 1102, defining a fluid passage along the entire length of the needle 1100. The hub 1115 facilitates the physical attachment of the needle 1100 to the syringe 1020 and also establishes a fluid connection between the fluid lumen 1120 and the syringe 1020.

[0074] The cannula 1110 further comprises a guideway lumen 1130 that extends along the length of the cannula 1110 from its tip 1113 to its proximal end 1112. The guideway lumen 1130 is sized to accommodate the placement of the guidewire 1030 into the guideway lumen 1130. The cannula 1110 comprises a slot 1135 that extends longitudinally along the length of the guideway lumen 1130. The slot 1135 extends radially through the guideway lumen wall 1131 and defines a slot width 1135A.

[0075] Figure 10C is a detailed perspective view of the proximal portion of the needle 1100, including a portion of the guidewire 1030 having a diameter of 1030A. The slot width 1135A is dimensioned to be smaller than the diameter 1030A of the guidewire 1030. Figure 10C shows the guidewire 1030, having a diameter of 1030A, inserted into the guideway lumen 1030 through the expanded portion 1136 of the slot 1135. The expanded portion 1136 defines the expanded slot width 1135B (see Figure 10D). The expanded slot width 1135B is dimensioned to be larger than the diameter 1030A of the guidewire 1030.

[0076] Figure 10D illustrates a general portion 1033 of a guide wire 1030 having a diameter 1030A and a reduced portion 1034 of a guide wire 1030 having a reduced diameter 1030B. The change in the diameter of the guide wire 1030 from diameter 1030A to the reduced diameter 1030B occurs at the transition portion 1036. The reduced diameter 1035B is dimensioned to be smaller than the slot width 1135A. In summary, the general portion 1033 having a diameter 1030A cannot pass laterally through the slot 1135 having a width 1135A, but it can pass through the expanded portion 1136 of the slot 1135 having a width 1135B. Similarly, the reduced portion 1034 of the guide wire 1030 having a reduced diameter 1030B can pass laterally through the slot 1135 having a width 1135A.

[0077] During use, the guidewire 30 can be inserted distally into the guideway lumen 1130 through the expanded portion 1136. As the general portion 1033 extends through the expanded portion 1136 of the slot 1135, the guidewire 30 can be further advanced along the guideway lumen 1130 into the vascular structure. This advancement may continue until the narrowed portion 11134 of the guidewire 30 is positioned close to the proximal end 1112 of the cannula 1110. At this point, the needle 1100 may be moved proximal to the guidewire 30 so that the narrowed portion 1134 moves longitudinally within the slot 1135. The proximal movement of the needle 1100 may continue until the narrowed portion 1134 moves longitudinally along the slot 1135 and exits from the distal end of the slot 1135, establishing separation of the needle 1100 from the guidewire 30.

[0078] A method for positioning the guidewire 30 within the vascular structure of patient 50 may include the following steps or processes: The guidewire can be inserted into the guideway lumen of the needle such that the distal end of the guidewire is positioned close to the distal end of the needle. The needle can be inserted through the skin of patient 50 such that the tip of the needle is positioned within the blood vessel. With the tip of the needle positioned within the blood vessel, blood can be drawn into a syringe through the fluid lumen of the needle to confirm that the tip of the needle is within the blood vessel. The guidewire can be advanced along the blood vessel through the guideway lumen of the needle. The needle can be separated laterally from the guidewire while the syringe remains attached to the needle. The step of inserting the guidewire into the guideway lumen may be performed before the step of inserting the needle through the skin.

[0079] Before the insertion step, the collar can be rotated to secure the guidewire to the needle, preventing it from moving longitudinally within the guideway lumen during needle insertion through the skin. The collar can also be rotated away from its fixed position to allow the guidewire to advance through the needle.

[0080] This method may include using a needle having a sheath, and this method may further include separating the needle from the guidewire by moving the guidewire laterally through a detachable portion of the sheath. When separating the needle from the guidewire, the guidewire can be moved laterally through a slot in the collar.

[0081] While several specific embodiments are disclosed herein, and some embodiments are disclosed in some degree of detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be understood by those skilled in the art. In broader embodiments, these adaptations and / or modifications are also encompassed. Thus, one may deviate from specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A needle for accessing the vascular structure of a patient, The sharp tip at the distal end, A connection hub at the proximal end, configured to connect to a syringe, A cannula extending from the distal end to the proximal end, comprising a cannula containing a fluid lumen extending from the distal end to the proximal end, A guideway lumen is provided in the cannula and extends parallel to the fluid lumen along the length of the cannula, and is configured such that a guidewire is positioned within the guideway lumen, A guideway slot extends through the outer wall of the cannula into the guideway lumen and defines the slot width. Equipped with, The slot width is sized to accommodate the lateral passage of the guidewire through the guideway slot into and out of the guideway lumen of the needle.

2. In the needle according to claim 1, A guideway slot is a needle that extends radially through the wall of the guideway lumen.

3. In the needle according to claim 1 or 2, The guideway slot is a part of the needle that extends along the lumen of the guideway to the distal end.

4. In the needle according to any one of claims 1 to 3, The width of the guideway slot can be approximately equal to or smaller than the diameter of the guideway lumen, for a needle.

5. The needle according to any one of claims 1 to 4 is further, It comprises a sheath positioned on the cannula along the length of the cannula that extends away from the distal end, A needle, with a sheath configured to hold the guidewire within the lumen of the guideway.

6. In the needle according to claim 5, A needle having a sheath wall with a separable portion extending from the distal end of the sheath to the proximal end of the sheath.

7. In the needle according to claim 6, The sheath is rotatable around the cannula between a first angular position and a second angular position. The detachable portion is positioned adjacent to the guideway slot in the first position. The detachable part is the needle, which is positioned away from the guideway slot in the second position.

8. In the needle according to any one of claims 5 to 7, A needle, in which the detachable portion is configured such that a guide wire passes through the detachable portion.

9. In the needle according to any one of claims 5 to 8, The detachable portion is a needle, configured such that the cannula passes through the detachable portion.

10. In the needle according to any one of claims 6 to 9, The detachable part is a needle with a slit.

11. In the needle according to any one of claims 1 to 10, The guideway lumen wall has a deflectable portion that extends at least partially across the guideway slot, The deflection portion is configured to hold the guide wire within the guideway slot when the deflection portion is in a non-deflection state. A needle whose deflection portion is configured to allow the guidewire to pass out of the guideway slot when the deflection portion is in a deflected state.

12. In a needle according to any one of claims 1 to 11, The fluid lumen comprises fluid lumen slots extending radially through the fluid lumen wall, The fluid lumen slot extends along the length of the cannula, away from the distal end. The width of the fluid lumen slot is approximately equal to or smaller than the diameter of the guideway lumen. A guideway is a needle that extends across the fluid lumen slot and defines a portion of the fluid lumen wall.

13. In a needle according to any one of claims 1 to 12, The guideway lumen wall and the fluid lumen wall are formed of different materials, like a needle.

14. In the needle according to claim 13, The guideway lumen wall is more flexible than the fluid lumen wall, as is the case with needles.

15. In a needle according to any one of claims 1 to 14, A needle with a fluid lumen having a non-circular cross-section.

16. In a needle according to any one of claims 1 to 15, The guideway slot is, A first slot portion having a first slot width, It comprises a second slot portion having a second slot width, The second slot width is larger than the first slot width for the needle.

17. In the needle according to claim 16, The first slot portion is a needle located distal to the second slot portion.

18. In the needle according to claim 16 or 17, The first slot portion extends distally to the distal end of the needle; this is the needle.

19. In a needle according to any one of claims 16 to 18, The first slot width is smaller than the diameter of the guide wire. The second slot width is larger than the diameter of the guide wire, for the needle.

20. In a needle according to any one of claims 1 to 19, A cannula is a needle with a non-circular cross-section.

21. In the needle according to claim 20, A cannula is a needle with an oval cross-section.

22. In the needle according to claim 20, A cannula is a needle with a triangular cross-section.

23. The needle according to any one of claims 1 to 19 is further, Equipped with a collar attached to the cannula, The cannula is placed inside the opening of the collar. The opening extends from the distal end of the collar to the proximal end of the collar. The collar is a needle that prevents the guidewire from moving laterally out of the guidewire lumen.

24. In the needle according to claim 23, The collar has collar slots that extend radially outward from the opening to the outer surface of the collar. The collar slot extends from the distal end of the collar to the proximal end of the collar. A color slot is a needle configured so that the guide wire passes laterally through the color slot.

25. In the needle according to claim 24, The collar is rotatably positioned on the cannula in a guidewire release position where the collar slot aligns with the guideway slot. When the collar is in the released position, the guidewire can be removed laterally from the guideway lumen. When the collar is rotated away from the release position, it prevents the guidewire from being removed laterally from the guideway lumen, thus preventing the needle from being pulled out.

26. In the needle according to any one of claims 23 to 25, The collar can be rotatably positioned on the cannula at the guidewire fixing position. When the collar is in the guidewire fixation position, the guidewire is prevented from moving longitudinally within the guideway lumen. A needle in which, when the collar is rotated away from the guidewire's fixed position, the guidewire can move longitudinally within the guideway lumen.

27. In the needle according to claim 26, When the collar is in the guide wire fixing position, rotation of the guide wire relative to the needle is prevented. A needle in which the guide wire can rotate relative to the needle when the collar is rotated away from the guide wire's fixed position.

28. In the needle according to any one of claims 23 to 27, The collar is a needle positioned on the cannula such that the second slot portion is located between the distal end and the proximal end of the collar.

29. In the needle according to any one of claims 23 to 28, The collar is the hand, which is attached to the sheath in such a way that it rotates in conjunction with the sheath.

30. A system for accessing the vascular structure of a patient, It is a needle, The sharp tip at the distal end, A connection hub at the proximal end, configured to connect to a syringe, A cannula extending from the distal end to the proximal end, comprising a cannula containing a fluid lumen extending from the distal end to the proximal end, A guideway lumen is provided in the cannula and extends parallel to the fluid lumen along the length of the cannula, and is configured such that a guidewire is positioned within the guideway lumen, A guideway slot extends through the outer wall of the cannula into the guideway lumen and defines the slot width. Including needles, A guide wire placed inside the guideway lumen, Equipped with, The slot width is sized to accommodate the lateral passage of the guidewire through the guideway slot into and out of the guideway lumen.

31. The system described in claim 30 further, A system comprising a syringe connected to a connection hub.

32. In the system according to claim 30 or 31, The needle further comprises a sheath positioned on the cannula along the length of the cannula extending away from the distal end, The sheath is configured to hold the guidewire within the guideway lumen. The sheath comprises a sheath wall having a separable portion extending from the distal end of the sheath to the proximal end of the sheath. A system in which a guide wire is configured to pass through a detachable section.

33. In the system described in claim 32, The sheath is rotatable around the cannula between a first angular position and a second angular position. The detachable portion is positioned adjacent to the guideway slot in the first position. The detachable part is positioned away from the guideway slot in the second position of the system.

34. In the system described in any one of claims 30 to 33, The guideway lumen wall has a deflectable portion that extends at least partially across the guideway slot, The deflection portion is configured to hold the guide wire within the guideway slot when the deflection portion is in a non-deflection state. A system in which a deflectionable portion is configured to allow the guide wire to pass out of the guideway slot when the deflectionable portion is in a deflected state.

35. In the system described in any one of claims 30 to 34, The guideway slot is, A first slot portion having a first slot width, It comprises a second slot portion having a second slot width, The second slot width is greater than the first slot width in the system.

36. In the system described in claim 35, The first slot width is smaller than the diameter of the guide wire. The second slot width is larger than the diameter of the guide wire in this system.

37. In the system according to claim 35 or 36, The guide wire is, A first diameter portion having a first diameter, It comprises a second diameter portion having a second diameter, The first diameter is greater than the first slot width. The second diameter is smaller than the first slot width in this system.

38. In the system described in any one of claims 30 to 37, The needle further includes a collar attached to the cannula. The cannula is positioned within the opening of the collar, and the opening extends from the distal end of the collar to the proximal end of the collar. A collar is a system that prevents the guidewire from moving laterally out of the guideway lumen.

39. In the system described in claim 38, The collar has collar slots that extend radially outward from the opening to the outer surface of the collar. The collar slot extends from the distal end of the collar to the proximal end of the collar. A color slot is a system configured so that the guide wire passes laterally through the color slot.

40. In the system according to claim 38 or 39, The collar is rotatably positioned on the cannula in a guidewire release position where the collar slot aligns with the guideway slot. When the collar is in the guidewire release position, the guidewire can be removed laterally from the guideway lumen. A system in which the collar is rotated away from the release position, preventing the guidewire from being removed laterally from the guideway lumen.

41. In the system described in any one of claims 38 to 40, The collar can be rotatably positioned on the cannula at the guidewire fixing position. When the collar is in the guidewire fixation position, the guidewire is prevented from moving longitudinally within the guideway lumen. A system in which, when the collar is rotated away from the guidewire's fixed position, the guidewire can move longitudinally within the guideway lumen.

42. In the system described in claim 41, When the collar is in the guide wire fixing position, rotation of the guide wire relative to the needle is prevented. A system in which the guide wire can rotate relative to the needle when the collar is rotated away from the guide wire's fixed position.

Images