Device for enabling the cannulation of a wire

Abstract

A system for deploying a preloaded guidewire to access a heart is disclosed. The system includes a device comprising an elongate body having a body length, a proximal end, and a distal end portion terminating at a distal tip, and a lumen extending through the elongate body and sized to slidably receive the preloaded guidewire. The system further includes a guidewire control device located on the device configured to physically communicate with the preloaded guidewire and cause the preloaded guidewire to longitudinally advance within the lumen. The preloaded guidewire includes an untriggered state and a triggered state. In the triggered state, the preloaded guidewire extends longitudinally within the lumen toward the distal tip of the device.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 568,974, filed March 22, 2024, entitled “DEVICE ENABLING WIRECANNULATION”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to medical systems and methods for accessing tissue within a patient's heart. More specifically, this disclosure relates to medical systems and methods for deploying a pre-loaded guidewire to access the heart and subsequent tissue within the heart. Background Technology

[0004] Typically, during cardiac surgery, the user may use several devices simultaneously or sequentially (e.g., transseptal needles, dilators, sheaths, multiple sutures, catheters, therapeutic devices, or combinations thereof) to access the heart and subsequent tissues within it. Operating multiple devices requires the user to be close to specific anatomical structures within the heart, maintain control of the devices, and keep them in the correct position relative to each other. Potential consequences of unintentional movement of the hand or fingers on these devices may include accidental tissue puncture, suboptimal transseptal puncture location that may increase surgical complexity, cardiac tamponade, accidental aortic puncture, and loss of the transseptal approach requiring a second puncture.

[0005] In these situations, it may be difficult to simultaneously insert a new filament through the sheath of a device (e.g., through a dilator) into the newly entered space. However, it is highly beneficial, and in many cases necessary, to supply filament into the newly entered space, for example, after a needle-based puncture, as it ensures access to that space and serves as a track for the sheath, dilator, and treatment device. Against this backdrop, there has been an industrial need for improved devices and methods for achieving access to and puncture of tissue within a patient's heart. Therefore, the object of the present invention is to provide such a device. Summary of the Invention

[0006] In Example 1, a system for deploying a preloaded guidewire to approach the heart includes a device comprising: an elongated body having a body length, a proximal end, and a distal end portion terminating at a distal end, and a lumen extending through the elongated body and sized to slidably receive the preloaded guidewire. The system also includes a guidewire control device located on the device, configured to physically communicate with the preloaded guidewire and to longitudinally advance the preloaded guidewire within the lumen; wherein the preloaded guidewire includes an untriggered state and a triggered state, and wherein, in the triggered state, the preloaded guidewire extends longitudinally within the lumen toward the distal end of the device.

[0007] Example 2 is the system described in Example 1, wherein the device is a puncture wire, and wherein the pre-loaded guide wire is inserted into the puncture wire through a lumen cannula of the puncture wire.

[0008] Example 3 is the system of any one of Examples 1-2, further comprising an expander that defines an expander lumen and has a handle at a proximal end portion of the expander, wherein the guidewire control device is located on the expander handle, and wherein the puncture wire is advanced through the expander lumen.

[0009] Example 4 is the system described in Example 1, wherein the device is an expander having a handle at the proximal end of the elongated body, and wherein the guidewire control device is located on the expander handle.

[0010] Example 5 is the system described in Example 1, wherein the guidewire control device includes a trigger feature, and wherein, when the trigger feature is actuated, the preloaded guidewire is in the trigger state.

[0011] Example 6 is the system described in Example 5, wherein the trigger feature is a button located on the device.

[0012] Example 7 is the system described in Example 1, wherein the guide wire control device is a position dial.

[0013] Example 8 is the system described in Example 7, wherein the position dial includes a traction element, and wherein the frictional force applied by the position dial to the preloaded guidewire causes the preloaded guidewire to advance longitudinally within the lumen.

[0014] Example 9 is the system described in Example 8, wherein the position dial is physically connected to a pre-loaded guidewire within the lumen, and wherein, when the position dial is rotated, the guidewire travels forward toward the distal end of the device.

[0015] Example 10 is the system described in Example 8, wherein the speed at which the position dial rotates is correlated with the speed at which the preloaded guidewire extends through the lumen.

[0016] Example 11 is the system described in Example 8, wherein a user can control the forward and backward movement of the preloaded guidewire by rotating the position dial.

[0017] Example 12 is the system described in Example 4, wherein the preloaded guidewire includes at least one or more grooves on the body of the preloaded guidewire, wherein the guidewire control device is a knob having a top portion extending from the dilator handle and a bottom portion located within the lumen, and wherein, when the knob is aligned with one of the at least one or more grooves on the preloaded guidewire, the user longitudinally advances the top portion of the knob onto the dilator, thereby advancing the preloaded guidewire longitudinally within the lumen.

[0018] Example 13 is the system described in Example 1, wherein the guidewire control device is an auxiliary device.

[0019] Example 14 is the system described in Example 13, wherein the auxiliary device is locked in the device and physically communicated with the pre-loaded guidewire, thereby controlling the longitudinal movement of the pre-loaded guidewire within the lumen.

[0020] Example 15 is the system described in Example 1, wherein the guidewire control device allows the preloaded guidewire to be advanced through the device with minimal manual movement.

[0021] In Example 16, a system for deploying a preloaded guidewire to approach the heart includes a tubular device comprising: an elongated body having a body length, a proximal end, and a distal end portion terminating at a distal end; and a lumen extending through the elongated body and sized to slidably receive the preloaded guidewire. The system also includes a guidewire control device located on the device, physically communicated with the preloaded guidewire, and controlling lateral movement of the preloaded guidewire within the lumen; wherein the preloaded guidewire includes an untriggered state and a triggered state, and wherein, in the triggered state, the preloaded guidewire extends longitudinally within the lumen toward the distal end of the device.

[0022] Example 17 is the system described in Example 16, wherein the device is a puncture wire, and wherein the pre-loaded guide wire is inserted into the puncture wire through a lumen cannula of the puncture wire.

[0023] Example 18 is the system described in Example 17, further including a dilator that defines a dilator lumen and has a handle at a proximal end portion of the dilator, wherein the guidewire control device is located on the dilator handle, and wherein the puncture wire is advanced through the dilator lumen.

[0024] Example 19 is the system described in Example 16, wherein the device is an expander having a handle at the proximal end of the elongated body, and wherein the guidewire control device is located on the expander handle.

[0025] Example 20 is the system described in Example 16, wherein the guidewire control device includes a trigger feature, and wherein, when the trigger feature is actuated, the preloaded guidewire is in the trigger state.

[0026] Example 21 is the system described in Example 20, wherein the trigger feature is a button on the handle.

[0027] Example 22 is the system described in Example 16, wherein the guidewire control device is a position dial on the handle.

[0028] Example 23 is the system described in Example 22, wherein the position dial includes a traction element, and wherein a frictional force applied by the position dial to the preloaded guidewire causes the preloaded guidewire to advance longitudinally within the lumen.

[0029] Example 24 is the system described in Example 22, wherein the position dial is physically connected to a pre-loaded guidewire within the lumen, and the guidewire travels forward toward the distal end of the device when the position dial is rotated.

[0030] Example 25 is the system described in Example 22, wherein the speed at which the position dial rotates is correlated with the speed at which the preloaded guidewire travels through the lumen.

[0031] Example 26 is the system described in Example 22, wherein a user can control the forward and backward movement of the preloaded guidewire by rotating the position dial.

[0032] Example 27 is the system described in Example 16, wherein the guidewire control device allows the preloaded guidewire to be advanced through the device with minimal manual movement.

[0033] In Example 28, a device for deploying a pre-loaded guidewire to approach the heart includes a means comprising: an elongated body having a body length, a proximal end, and a distal end portion terminating at a distal end; and a lumen extending through the elongated body and sized to slidably receive the pre-loaded guidewire. The device further includes a guidewire control means located on the means, configured to physically communicate with the pre-loaded guidewire and to longitudinally advance the pre-loaded guidewire within the lumen; wherein the pre-loaded guidewire includes an untriggered state and a triggered state; wherein, in the triggered state, the pre-loaded guidewire extends longitudinally within the lumen toward the distal end of the means; and wherein the means is a puncture wire, and wherein the pre-loaded guidewire is inserted into the puncture wire through a lumen cannula.

[0034] Example 29 is the apparatus described in Example 28, further comprising a dilator defining a dilator lumen and having a handle at a proximal end portion of the dilator, wherein the guidewire control device is located on the dilator handle, and wherein the puncture wire is advanced through the dilator lumen.

[0035] Example 30 is the apparatus described in Example 28, wherein the guidewire control device includes a trigger feature, and wherein, when the trigger feature is actuated, the preloaded guidewire is in the trigger state.

[0036] Example 31 is the device described in Example 30, wherein the trigger feature is a button on the expander handle.

[0037] Example 32 is the device described in Example 28, wherein the preloaded guidewire includes at least one or more grooves on the body of the preloaded guidewire, wherein the guidewire control device is a knob having a top portion extending from the dilator handle and a bottom portion located within the lumen, and wherein, when the knob is aligned with one of the at least one or more grooves on the preloaded guidewire, the user longitudinally advances the top portion of the knob onto the dilator, thereby advancing the preloaded guidewire longitudinally within the lumen.

[0038] Example 33 is the apparatus described in Example 28, wherein the guidewire control device is an auxiliary device.

[0039] Example 34 is the device described in Example 33, wherein the accessory is locked in the expander handle and physically communicates with the pre-loaded guidewire, thereby controlling the longitudinal movement of the pre-loaded guidewire within the expander lumen.

[0040] In Example 35, a method for deploying a preloaded guidewire includes providing an apparatus comprising an elongated body having a body length, a proximal end and a distal end portion terminating at a distal end, and a lumen extending through the elongated body and sized to slidably receive the preloaded guidewire. The method further includes providing a guidewire control device located on the apparatus, the guidewire control device being configured to physically communicate with the preloaded guidewire and to longitudinally advance the preloaded guidewire within the lumen; wherein the preloaded guidewire includes an untriggered state and a triggered state, and wherein, in the triggered state, the guidewire control device is physically communicated with the preloaded guidewire, and the preloaded guidewire extends longitudinally within the lumen toward the distal end of the apparatus.

[0041] While several embodiments have been disclosed, other embodiments of this disclosure will become apparent to those skilled in the art from the following detailed description of the illustrative embodiments shown and described herein. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive. Attached Figure Description

[0042] Figure 1A-1B This is a schematic diagram of a medical procedure in a patient's heart for achieving access to the interatrial septum and epicardial space and for ablating cardiac tissue, according to an embodiment of the present disclosure.

[0043] Figure 2 This is an illustration of a system for deploying a preloaded guidewire within an expander, according to an embodiment of the present disclosure.

[0044] Figure 3 It is located according to the embodiments of this disclosure. Figure 2 A schematic diagram of an exemplary guidewire control device for controlling the advance of a preloaded guidewire on an expander.

[0045] Figures 4A-4B The embodiment shown is located in accordance with the present disclosure. Figure 2 An exemplary guidewire control device for controlling the advance of a preloaded guidewire on an expander.

[0046] While this disclosure may have various modifications and alternatives, specific embodiments are shown by way of example in the accompanying drawings and are described in detail below. However, this disclosure is not intended to limit the disclosure to the specific embodiments described. Rather, this disclosure is intended to cover all modifications, equivalents, and alternatives that fall within the scope of protection of this disclosure as defined by the appended claims. Detailed Implementation

[0047] To facilitate understanding of the principles of this disclosure, reference is now made to the examples illustrated in the accompanying drawings, which are described below. The examples shown herein are not intended to be exhaustive or to limit this disclosure to the precise forms disclosed in the following detailed description. Rather, these exemplary embodiments were chosen and described to enable others skilled in the art to use their technical teachings. Applying multiple (e.g., all) features from a given example to all other examples does not exceed the scope of this disclosure. Therefore, no single drawing should be construed as having any dependence on or necessity for any individual component or combination of components shown therein. Furthermore, in the examples, various components depicted in a given drawing may be integrated with various components in other components (and / or components not shown) depicted therein, all of which are considered to fall within the scope of this disclosure.

[0048] Figure 1A-1B This is a schematic diagram of a medical procedure performed within a patient's heart to achieve access to the interatrial septum and epicardial space, according to an embodiment of the present disclosure. Figure 1A This is a diagram of a medical procedure 10 performed within a patient's heart 20 using a transatrial septal approach system 50. As is known, the human heart 20 has four chambers: the right atrium 55, the left atrium 60, the right ventricle 65, and the left ventricle 70. Separating the right atrium 55 and the left atrium 60 is the atrial septum 75, and separating the right ventricle 65 and the left ventricle 70 is the ventricular septum 80. As further known, deoxygenated blood from the patient's body returns to the right atrium 55 via the inferior vena cava (IVC) 85 or the superior vena cava (SVC) 90.

[0049] Various medical procedures have been developed to diagnose or treat physiological disorders originating from the left atrium 60 and related structures. Exemplary such procedures include, but are not limited to, the deployment of a diagnostic or mapping catheter within the left atrium 60 to generate electroanatomical mappings or diagnostic images of it. Other exemplary procedures include endocardial catheter-based ablation (e.g., radiofrequency ablation, pulsed field ablation, cryoablation, laser ablation, high-frequency ultrasound ablation, etc.) of targeted sites within the chamber or adjacent vessels (e.g., pulmonary veins and their openings) to terminate arrhythmias such as atrial fibrillation and atrial flutter. Other exemplary procedures may include the deployment of a left atrial appendage (LAA) occlusion device. Of course, the above examples of procedures within the left atrium 60 are merely illustrative and are by no means limiting of this disclosure.

[0050] Procedures providing access to the left atrium 60 utilize transseptal access systems and devices for subsequent deployment of the aforementioned diagnostic and / or therapeutic devices within the left atrium 60. In these procedures, the target tissue site may be defined by tissue on the atrial septum 75. Access to the target site is made via the inferior vena cava (IVC) 85, for example, through the femoral vein, according to conventional catheter insertion techniques. In other embodiments, a superior approach may be used to access the target site on the atrial septum 75, wherein the transseptal access system 50 is advanced into the right atrium 55 via the superior vena cava (SVC) 90.

[0051] The transseptal approach system procedure may include a number of devices, such as an insertion sheath 100, a dilator 105, a puncture device having a distal end portion 112 terminating at a terminal electrode 115, and a guidewire. In various embodiments, the puncture device 110 is a mechanical puncture device (e.g., a needle) or an RF puncture device. In one embodiment, the puncture device 110 may be disposed within the dilator 105, which itself may be disposed within the sheath 100. In another embodiment, the dilator 105 and the sheath 100 may be integrated into a single device, and the puncture device 110 may be disposed within said device. In other embodiments, the dilator 105 and the puncture device 110 may be integrated into a single device and subsequently inserted into the sheath 100. In one embodiment, the transseptal approach system 50 is deployed into the right atrium 55 via IVC 85, and the user introduces a guidewire (not shown) into the femoral vein (typically the right femoral vein) and advances it toward the heart 20. The sheath 100 may then be introduced over the guidewire into the femoral vein and advanced toward the heart 20. In one embodiment, the distal ends of the guidewire and sheath 100 are then positioned in the SVC 90. These steps can be performed with the assistance of an imaging system, such as fluoroscopy or ultrasound imaging. The dilator can be fully inserted into the sheath before entering the body, and both can be advanced toward the heart simultaneously. Alternatively, the dilator can then be introduced into the sheath on the guidewire and advanced through the sheath into the SVC.

[0052] Once the guidewire, sheath 100, and dilator 105 are positioned in the SVC 90, the guidewire is removed from the body, and the sheath 100 and dilator 105 are retracted such that their distal ends are positioned in the right atrium 55. In one embodiment, the described puncture device 110 can then be introduced into the dilator 105 and advanced toward the heart 20. In another embodiment, the puncture device 110 can be introduced before the sheath 100 and dilator 105 are retracted from the SVC into the right atrium. In one embodiment, the puncture device 110 is subsequently positioned such that the distal electrode 115 is aligned with or slightly protrudes from the distal end of the dilator 105. In embodiments where the puncture device 110 is an RF puncture device, the distal electrode 115 and dilator 105 are located at the target site, and energy is delivered from an energy source (e.g., an RF generator) through the RF puncture device 110 to the distal electrode 115 and the target site. In some embodiments, energy is delivered at a power of at least about 5 W and a voltage of at least about 565 V (peak-to-peak) to vaporize cells near the terminal electrode, thereby creating a gap or perforation through the tissue at the target site. The user then applies force to the RF perforation device 110 to advance the terminal electrode 115 at least partially through the perforation. In these embodiments, energy delivery ceases when the terminal electrode 115 has penetrated the target tissue, that is, when the terminal electrode has reached the left atrium 60. In some embodiments, the energy delivery step occurs within a time period of approximately 1 second to approximately 5 seconds. In other embodiments, the energy delivery step occurs within a time period of approximately 300 milliseconds (ms).

[0053] like Figure 1B As shown, another medical procedure 10 developed for the diagnosis or treatment of physiological disorders originating within the heart 20 includes epicardial ablation to help restore a regular heart rhythm. As illustrated, the heart 20 comprises a pericardium 40, a pericardial cavity 42, and myocardium 44. The subxiphoid approach is typically used to access the heart 20. The epicardial approach is achieved by puncturing one layer of the pericardium 40 while avoiding the myocardium 44 of the heart. The pericardium 40 is a strong, double-walled fibroelastic sac that encloses the heart 20 and the roots of the great vessels. The pericardium 40 comprises two layers: an outer layer formed of strong connective tissue, commonly referred to as the fibrous pericardium, and an inner layer formed of serous membrane, commonly referred to as the serous pericardium. The mesothelial cells or mesothelial cells constituting the serous pericardium also act as an epicardium covering the myocardium of the heart, thus forming a continuous serous membrane that folds back into two opposing surfaces, such as covering the fibrous pericardium 40 and the heart 20. This creates a pouch-like virtual or potential space around the heart 20, which is surrounded between two opposing serous membrane surfaces and is commonly referred to as the pericardial space or pericardial cavity 42.

[0054] In some embodiments, the pericardium 40 can be punctured using a puncture device 110, such as a needle (or other mechanical puncture device). Once punctured, a dilator 105 is advanced to dilate the perforation created by the needle passing through the pericardium 40. In some embodiments, a sheath 100 may be advanced simultaneously with the dilator 105. In other embodiments, the sheath 100 may be advanced subsequently. The sheath 100 and dilator 105 can then be withdrawn to leave the guidewire 104 in the pericardial cavity 42. The diagnosis and treatment of various arrhythmias and other conditions require minimally invasive access to the epicardium. During epicardial ablation, tiny scars are created on the outside of the heart to produce transmural damage. In other words, tissue ablation is achieved through the thick muscle of the heart.

[0055] This disclosure describes novel systems and methods for providing safe access to the heart. As will be explained in more detail herein, embodiments of this disclosure improve complex cardiac procedures by providing a pre-loaded guidewire deployment mechanism.

[0056] Figure 2 This is an illustration of a system for deploying a pre-loaded guidewire 210, integrated with a dilator 205, according to an embodiment of the present disclosure, to approach the heart. As shown, the dilator 205 includes an elongated dilator body 220 having a body length, a dilator handle 224 having a handle length, and a dilator lumen 230 extending longitudinally through the handle 224 and the dilator body 220. Furthermore, the dilator body 220 includes a proximal end portion 221 and an opposing distal end portion 222 terminating at a distal end 226. In one embodiment, the handle 224 is connected to the proximal end portion 221 of the dilator body 220. In one embodiment, the body length and handle length together define the dilator length. Furthermore, as shown, the lumen 230 of the dilator 205 is sized to slidably receive the guidewire 210. In some embodiments, the guidewire 210 may be pre-loaded into the dilator 205 when the procedure requires its use.

[0057] from Figure 2 It can also be seen that the pre-loaded guidewire 210 includes a guidewire body having a proximal portion 260 and a distal portion 266, the distal portion extending from the proximal portion 260 and terminating at a distal end 268. It should be understood that in some embodiments, the length of the guidewire 210 is greater than the length of the dilator 205, such that when the distal portion 266 (particularly the distal end 268) extends distally from the dilator 205, a portion of the proximal portion 260 of the guidewire 210 extends proximally from the handle 224, thereby allowing the user to manipulate the proximal portion 260 as needed. In some embodiments, the pre-loaded guidewire 210 can be inserted into the dilator 205 and pass through another medical device, such as a transatrial septal needle.

[0058] In another embodiment, the system for deploying the preloaded guidewire 210 may include a puncture wire (not shown) comprising an elongated body having a body length, a proximal end, and a distal end portion terminating at a distal end, and a hollow lumen extending through the elongated body and sized to slidably receive the preloaded guidewire 210. In one embodiment, the preloaded guidewire 210 may be inserted into the puncture wire through a hollow lumen cannula. In some embodiments, the puncture wire itself may then be advanced through a dilator lumen 230 through a dilator 205. In one embodiment, as described above... Figure 1A-1B After puncturing the target tissue through the hollow lumen of the puncture filament, the pre-loaded guidewire 210 can then be immediately advanced through the hollow lumen of the puncture filament via a guidewire control device 270 positioned on the dilator 205 to ensure proximity to the puncture site created by the puncture filament. In one embodiment, the puncture filament is a mechanical puncture device (e.g., a needle). In another embodiment, the puncture filament is an RF puncture device.

[0059] from Figure 2 As can be further seen and explained in more detail below, the system further includes a guidewire control device 270 located on the dilator 205. In some embodiments, the guidewire control device 270 may be located on the dilator handle 224. In one embodiment, the guidewire control device 270 is configured to physically communicate with a pre-loaded guidewire 210 and to longitudinally advance the pre-loaded guidewire 210 within the dilator lumen 230. In other embodiments, where the pre-loaded guidewire 210 is cannulated into a puncture wire integrated with the dilator 205, the guidewire control device 270 is configured to physically communicate with the pre-loaded guidewire 210 within the puncture wire and to longitudinally advance the pre-loaded guidewire 210 within the hollow lumen of the puncture wire. Therefore, in some embodiments, the guidewire control device 270 may include an upper portion extending from the dilator 205 for user manipulation, and a lower portion extending through the dilator handle 224 and into the dilator lumen 230, and in some cases, the lower portion extends through the puncture wire lumen and is physically in communication with the pre-loaded guidewire 210. In some embodiments, the pre-loaded guidewire 210 includes an untriggered state in which the guidewire 210 is located within the dilator lumen 230, such as... Figure 2As shown. In one embodiment, in the untriggered state, the distal portion 266 of the preloaded guidewire 210 may be located in the dilator lumen 230, near the dilator handle 224 or near the proximal end 221 of the dilator body 220. In some embodiments, the preloaded guidewire 210 further includes a triggered state in which, due to actuation of the guidewire control device 270, the preloaded guidewire 210 is advanced longitudinally within the dilator lumen 230 toward the distal end 226 of the dilator 205 or distal to the distal end 226 of the dilator 205. In some embodiments, the guidewire control device 270 may be a lever, wheel, screw, button, or any other structure that may be positioned on and within the dilator 205 and configured to be in physical communication with the preloaded guidewire 210 to advance longitudinally within the dilator lumen 230 and, in some cases, through the puncture wire lumen.

[0060] In one embodiment, the guidewire control device 270 may include a trigger feature, wherein when the trigger feature is actuated, the preloaded guidewire 210 is in a triggered state. In one embodiment, the trigger feature may be a button located on the expander handle 224. In one embodiment, the trigger feature may be actuated by user manipulation (i.e., pressing a button, rotating a wheel, or lever, etc.).

[0061] Figure 3 This is a schematic diagram of a position dial 372 located on the expander 305 to control the advance of a preloaded guide wire 310 according to an embodiment of the present disclosure. In one embodiment, Figure 2 The guide wire control device 270 may include a position dial 372 located on the expander handle 324. As shown, the position dial 372 includes a top portion extending from the expander handle 324 for user manipulation, a middle portion located within the expander handle 324, and a bottom portion extending into the expander lumen 330 and physically communicating with the pre-loaded guide wire 310. In one embodiment, the position dial 372 may include a traction element, wherein frictional forces applied by the position dial 372 to the pre-loaded guide wire 310 cause the guide wire 310 to advance longitudinally within the expander lumen 330 and, in some cases, through the puncture wire lumen. Thus, in one embodiment, as shown, when the user rotates the position dial 372, the traction element on the dial 372 causes the pre-loaded guide wire 310 to advance longitudinally within the expander lumen 330, thereby triggering the pre-loaded guide wire 310. In some embodiments, the user may rotate the position dial 372 with their fingers (i.e., with minimal involvement of the palm and / or several fingers).

[0062] In one embodiment, when the user rotates the dial 372 counterclockwise, the guide wire 310 can be advanced toward the distal end 326 of the dilator 305, such as... Figure 3 As shown. In other embodiments, when the user rotates the position dial 372 clockwise, the guidewire 310 can be advanced toward the distal end 326 of the dilator 305. In one embodiment, the rotation speed of the position dial 372 can be correlated with the speed at which the guidewire 310 travels through the dilator lumen 330. In other embodiments, the user can rotate the position dial 372 in the opposite direction to retract the guidewire 310 back into the dilator lumen 330 and render it untriggered. In yet another embodiment, the user can rotate the position dial 372 in the opposite direction to completely remove the pre-loaded guidewire 310 from the dilator 305. Thus, in one embodiment, the user can control the forward and backward longitudinal movement of the pre-loaded guidewire 310 by rotating the position dial 372. In one embodiment, the position dial 372 can be made of a polymer, metal, or a combination thereof. In some embodiments, a feature may be added to the surface of the expander lumen 330 opposite to the position dial 372 to reduce any frictional damage to the guide wire 310 that may be caused by the rolling of the traction element and the dial 372 on the guide wire 310. In one embodiment, the feature may be included in the region opposite the traction element. In another embodiment, the feature may be included in a section that includes but extends beyond the region opposite the traction element, for example, the entire lumen 330 or a portion of the lumen 330. In some embodiments, the feature may be a lubricating material, such as silicone, or may be a layer or coating, such as PTFE. In yet another embodiment, the feature may also include a moving element, such as a bearing, roller, or wheel, to facilitate translation of the guide wire.

[0063] Figures 4A-4B A guidewire control device according to an embodiment of the present disclosure and a pre-loaded guidewire 410 having at least one or more grooves 415 are shown. In one embodiment, located at Figure 2 The guidewire control device 270 on the expander 205 may include a knob 474 having a top portion extending from the expander handle 424 and a bottom portion located within the expander lumen 430. In one embodiment, the preloaded guidewire 415 may include at least one or more grooves 415 located on the body of the preloaded guidewire 410. In one embodiment, the shape of at least one or more grooves 415 may match the shape of the bottom portion of the knob 474, such that in the triggered state, the bottom portion of the knob 474 can be aligned with at least one or more grooves 415 of the preloaded guidewire 410.

[0064] In some embodiments, Figure 4AThe diagram depicts a pre-loaded guidewire 410 in an untriggered state, in which the knob 474 is not actuated and therefore not aligned with at least one or more grooves 415 on the guidewire 410. In one embodiment, the knob 474 can be actuated by a user by pressing down on the knob 474, while also slightly advancing the pre-loaded guidewire 474 within the dilator lumen if necessary, to align the knob 474 with at least one or more grooves 415 on the guidewire 410. In other embodiments, when the knob 474 is aligned with one of at least one or more grooves 415 on the pre-loaded guidewire 410, the user can longitudinally advance the top portion of the knob 474 onto the dilator handle 424, thereby advancing the pre-loaded guidewire 410 longitudinally within the dilator lumen 430. In one embodiment, a 1 mm movement of the knob 474 can translate to a 1 mm movement of the guidewire 410. In another embodiment, a 1 mm movement of the knob 474 can translate to a 3 mm movement of the guidewire 410.

[0065] In some embodiments, Figure 2 The guidewire control device 270 may be an accessory that can be attached to the expander handle and physically communicate with the pre-loaded guidewire. In one embodiment, the accessory can control the longitudinal movement of the pre-loaded guidewire within the expander lumen. In another embodiment, the guidewire control device allows the guidewire to be advanced through the expander with minimal manual movement.

[0066] As is well known, methods comprising one or more steps are not limited by the order listed in the claims unless expressly or implicitly stated otherwise in the specification or the claims themselves. It is also well known that the methods shown are merely some examples among the many disclosed examples, and certain steps may be added or omitted without departing from the scope of this disclosure. These steps may include combining apparatus, systems, or methods or components thereof, as well as those known, conventional, and routine in the art.

[0067] The connecting lines shown in the various figures contained herein are intended to illustrate exemplary functional relationships and / or physical connections between various elements. It should be noted that many alternative or additional functional relationships or physical connections may exist in actual systems. However, any benefit, advantage, solution to a problem, and any element that may cause any benefit, advantage, or solution to occur or become more apparent should not be construed as a critical, essential, or fundamental feature or element. Therefore, the scope is limited only by the appended claims, wherein, unless expressly stated otherwise, reference to a singular element does not mean "one and only one," but rather "one or more." Furthermore, when phrases such as "at least one of A, B, or C" are used in the claims, such phrases are intended to be interpreted as meaning that A exists alone in one embodiment, B exists alone in one embodiment, C exists alone in one embodiment, or any combination of elements A, B, or C may exist in a single embodiment; for example, A and B, A and C, B and C, or A and B and C. The terms “couples”, “coupled”, “connection”, “attachment” and their variations are used to describe arrangements that include two or more components in direct physical contact and arrangements in which two or more components are not in direct contact with each other (e.g., components are “coupled” via at least a third component) but still cooperate or interact with each other.

[0068] In the detailed description herein, references to "one embodiment," "an embodiment," "exemplary embodiment," etc., indicate that the described embodiment may include specific features, structures, or characteristics, but each embodiment does not necessarily include those specific features, structures, or characteristics. Furthermore, these phrases do not necessarily refer to the same embodiment. Moreover, when specific features, structures, or characteristics are described in connection with embodiments, it is understood that those skilled in the art, with the benefit of this disclosure, can apply those features, structures, or characteristics to other embodiments (whether explicitly described or not). After reading the description, those skilled in the art will understand how to implement this disclosure in alternative embodiments.

[0069] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the above embodiments relate to specific features, the scope of this disclosure also includes embodiments with different combinations of features and embodiments that do not include all of the stated features. Therefore, the scope of this disclosure is intended to encompass all such substitutions, modifications, and variations falling within the scope of the claims, as well as all their equivalents.

Claims

1. A system for deploying a pre-loaded guidewire to approach the heart, the system comprising: The device includes: an elongated body having a body length, a proximal end, and a distal end portion terminating at a distal end; and a lumen extending through the elongated body and sized to slidably receive the pre-loaded guidewire; and A guidewire control device located on the device, the guidewire control device being configured to be physically connected to the preloaded guidewire and to advance the preloaded guidewire longitudinally within the lumen; The preloaded guidewire includes an untriggered state and a triggered state, wherein, in the triggered state, the preloaded guidewire extends longitudinally within the lumen toward the distal end of the device.

2. The system according to claim 1, wherein, The device is a puncture wire, wherein the pre-loaded guide wire is inserted into the puncture wire through the lumen cannula of the puncture wire.

3. The system according to any one of claims 1-2, further comprising an expander defining an expander lumen and having a handle at a proximal end portion of the expander, wherein, The guide wire control device is located on the expander handle, and the puncture wire is advanced through the expander lumen.

4. The system according to claim 1, wherein, The device is an expander having a handle at the proximal end of the elongated body, wherein the guidewire control device is located on the expander handle.

5. The system according to claim 1, wherein, The guidewire control device includes a trigger feature, wherein when the trigger feature is actuated, the preloaded guidewire is in the trigger state.

6. The system according to claim 5, wherein, The trigger feature is a button located on the device.

7. The system according to claim 1, wherein, The guide wire control device is a position dial.

8. The system according to claim 7, wherein, The position dial includes a traction element, and wherein the frictional force applied by the position dial to the preloaded guidewire causes the preloaded guidewire to advance longitudinally within the lumen.

9. The system according to claim 8, wherein, The position dial is physically connected to a pre-loaded guidewire within the lumen, and wherein, when the position dial is rotated, the guidewire travels forward toward the distal end of the device.

10. The system according to claim 8, wherein, The speed at which the position dial rotates is related to the speed at which the pre-loaded guidewire extends through the lumen.

11. The system according to claim 8, wherein, The user can control the forward and backward movement of the preloaded guidewire by rotating the position dial.

12. The system according to claim 4, wherein: The preloaded guidewire includes at least one or more grooves located on the body of the preloaded guidewire; The guidewire control device is a knob having a top portion extending from the dilator handle and a bottom portion located within the lumen; and When the knob is aligned with one of the grooves on the preloaded guidewire, the user pushes the top portion of the knob longitudinally onto the expander, thereby advancing the preloaded guidewire longitudinally within the lumen.

13. The system according to claim 1, wherein, The guidewire control device is an auxiliary device.

14. The system according to claim 13, wherein, The auxiliary device is locked in the device and physically communicates with the pre-loaded guidewire, thereby controlling the longitudinal movement of the pre-loaded guidewire within the lumen.

15. The system according to claim 1, wherein, The guidewire control device allows the pre-loaded guidewire to be advanced through the device with minimal manual movement.

16. A system for deploying a pre-loaded guidewire to approach the heart, the system comprising: A tubular device comprising: an elongated body having a body length, a proximal end, and a distal end portion terminating at a distal end; a lumen extending through the elongated body and sized to slidably receive the pre-loaded guidewire; and A guidewire control device located on the device, the guidewire control device being physically connected to the pre-loaded guidewire and controlling the lateral movement of the pre-loaded guidewire within the lumen; The preloaded guidewire includes an untriggered state and a triggered state, wherein, in the triggered state, the preloaded guidewire extends longitudinally within the lumen toward the distal end of the device.

17. The system according to claim 16, wherein, The device is a puncture wire, wherein the pre-loaded guide wire is inserted into the puncture wire through the lumen cannula of the puncture wire.

18. The system of claim 17, further comprising an expander defining an expander lumen and having a handle at a proximal end portion of the expander, wherein, The guide wire control device is located on the expander handle, and the puncture wire is advanced through the expander lumen.

19. The system according to claim 16, wherein, The device is an expander having a handle at the proximal end of the elongated body, wherein the guidewire control device is located on the expander handle.

20. The system according to claim 16, wherein, The guidewire control device includes a trigger feature, wherein when the trigger feature is actuated, the preloaded guidewire is in the trigger state.

21. The system according to claim 20, wherein, The trigger feature is the button on the handle.

22. The system according to claim 16, wherein, The guidewire control device is the position dial on the handle.

23. The system according to claim 22, wherein, The position dial includes a traction element, and wherein the frictional force applied by the position dial to the preloaded guidewire causes the preloaded guidewire to advance longitudinally within the lumen.

24. The system according to claim 22, wherein, The position dial is physically connected to a pre-loaded guidewire within the lumen, and wherein, when the position dial is rotated, the guidewire travels forward toward the distal end of the device.

25. The system according to claim 22, wherein, The speed at which the position dial rotates is related to the speed at which the pre-loaded guidewire travels through the lumen.

26. The system according to claim 22, wherein, The user can control the forward and backward movement of the preloaded guidewire by rotating the position dial.

27. The system according to claim 16, wherein, The guidewire control device allows the pre-loaded guidewire to be advanced through the device with minimal manual movement.

28. A device for deploying a pre-loaded guidewire to approach the heart, the device comprising: The device includes: an elongated body having a body length, a proximal end, and a distal end portion terminating at a distal end; and a lumen extending through the elongated body and sized to slidably receive the pre-loaded guidewire; and A guidewire control device positioned on the device, the guidewire control device being configured to be physically connected to the preloaded guidewire and to advance the preloaded guidewire longitudinally within the lumen; The pre-loaded guidewire includes an untriggered state and a triggered state, wherein, in the triggered state, the pre-loaded guidewire extends longitudinally within the lumen toward the distal end of the device; and The device is a puncture wire, and the pre-loaded guide wire is inserted into the puncture wire through the lumen cannula of the puncture wire.

29. The apparatus of claim 28, further comprising a dilator defining a dilator lumen and having a handle at a proximal end portion of the dilator, wherein, The guide wire control device is located on the expander handle, and the puncture wire is advanced through the expander lumen.

30. The apparatus according to claim 28, wherein, The guidewire control device includes a trigger feature, wherein when the trigger feature is actuated, the preloaded guidewire is in the trigger state.

31. The apparatus according to claim 30, wherein, The trigger feature is a button on the expander handle.

32. The apparatus according to claim 28, wherein: The preloaded guidewire includes at least one or more grooves located on the body of the preloaded guidewire; The guidewire control device is a knob having a top portion extending from the dilator handle and a bottom portion located within the lumen; and When the knob is aligned with one of the grooves on the preloaded guidewire, the user pushes the top portion of the knob longitudinally onto the expander, thereby advancing the preloaded guidewire longitudinally within the lumen.

33. The apparatus according to claim 28, wherein, The guidewire control device is an auxiliary device.

34. The apparatus according to claim 33, wherein, The accessory device is locked in the expander handle and physically communicates with the pre-loaded guidewire, thereby controlling the longitudinal movement of the pre-loaded guidewire within the expander lumen.

35. A method for deploying a pre-loaded guidewire, the method comprising: Provides an apparatus comprising: an elongated body having a body length, a proximal end, and a distal end portion terminating at a distal end; and a lumen extending through the elongated body and sized to slidably receive the pre-loaded guidewire; and A guidewire control device is provided on the device, the guidewire control device being configured to be physically connected to the preloaded guidewire and to advance the preloaded guidewire longitudinally within the lumen; The preloaded guidewire includes an untriggered state and a triggered state, wherein, in the triggered state, the guidewire control device is physically connected to the preloaded guidewire, and the preloaded guidewire extends longitudinally within the lumen toward the distal end of the device.

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