Hublock for tissue perforation devices

Abstract

A puncture system for accessing a location within or near the heart of a patient is disclosed. The system includes a puncture device having a proximal portion and a distal portion including a distal tip. The system further includes an elongated introducer that defines a lumen adapted to receive the puncture device and allow its longitudinal movement, the elongated introducer having a proximal introducer portion and a distal introducer portion, the proximal introducer portion including a fixation hub. The fixation hub includes a slot and a mating surface, and is configured so that the proximal portion can be positioned in the slot and against the mating surface to generate a fixation friction force between the proximal portion and the mating surface. This fixation friction force is large enough to prevent longitudinal movement of the puncture device relative to the elongated introducer.

Description

Technical Field

[0001] The present invention generally relates to methods and devices for accessing anatomical structures within a patient's body. More specifically, the present invention relates to a hub block for use in combination with a tissue piercing system.

Background Art

[0002] Currently, there are devices for creating punctures, channels, or perforations within tissue located within a patient's body. In the case of a radiofrequency (RF) guide wire used to access a location within or near a patient's heart (e.g., epicardial or transseptal access), the RF guide wire is inserted into the opening at the proximal end of the introducer, and the introducer is guided through until the guide wire exits the distal end of the introducer and the RF electrode at the tip of the RF guide wire protrudes from the distal end of the introducer. In this case, the RF guide wire can move freely back and forth within the introducer. To accurately and repeatedly puncture the target site, it is necessary to accurately position the electrode tip of the RF guide wire.

[0003] Some currently available devices feature a collar positioned behind the tip electrode of the RF guidewire, which is used as a hard stop to precisely position the electrode relative to the rigid sheath. Thus, when the user is ready to advance the RF guidewire using the rigid sheath, the force advancing the rigid sheath is transmitted to the RF guidewire via the electrode collar, thereby maintaining the correct electrode position at the target site relative to the rigid sheath while the force advancing the rigid sheath into the patient is being applied. Other current devices are positioned using a proximal marker. However, such devices lack a mechanism to ensure that the electrode tip remains in place at the tip of the introducer even when a force acting on the tip electrode away from the introducer sheath is being applied. This force may include the electrode being pinched or caught in tissue when the introducer is retracted, or the user unintentionally pushing the RF guidewire forward. Furthermore, the tip electrode may be pushed back into the introducer, and once inside the introducer and / or dilator, the tip will no longer be in contact with tissue and will not be able to puncture or perforate it.

[0004] Against this backdrop, there is a continuing need in the industry to provide improved locking mechanisms for radiofrequency drilling devices and methods. Therefore, an object of the present invention is to provide such methods and devices. [Overview of the project]

[0005] In Example 1, a puncture system for accessing a location within or near the patient's heart includes a puncture device having a proximal puncture device portion and a distal puncture device portion including a distal tip, and an elongated introducer defining a lumen adapted to receive the puncture device and allow its longitudinal movement, wherein the elongated introducer has an introducer proximal portion and an introducer distal portion, the introducer proximal portion including a fixing hub, the fixing hub including a slot and the fixing hub including the fixing hub including the fixing hub including the fixing hub including the fixing hub, the fixing hub including the fixing hub including the fixing hub, the fixing hub including the fixing hub, the fixing hub including the fixing hub, the fixing hub including the fixing hub, the fixing hub including the fixing hub, the fixing hub including the fixing hub, the fixing hub including the fixing hub, and the fixing hub including the fixing hub, the fixing hub is sufficient to prevent the longitudinal movement of the puncture device relative to the elongated introducer.

[0006] Example 2 is the same drilling system as in Example 1, but with a J-shaped opening for the slot. Example 3 is a drilling system of either Example 1 or 2, wherein the slot further includes an entry slot.

[0007] Example 4 is a drilling system of any of Examples 1-3, wherein the slot further includes fixed slots. Example 5 is a puncture system from Examples 1-4 in which the proximal portion of the puncture device can be positioned within the entry slot and can also be bent toward the fixed slot.

[0008] Example 6 is a puncture system from any of Examples 1 to 5, in which the proximal portion of the puncture device is bent at approximately 45 to 90 degrees relative to the fixed hub. Example 7 is a puncture system according to any of Examples 1 to 5, wherein the puncture device is an RF puncture wire having an electrically active distal tip, and the proximal portion of the RF puncture wire is inserted into the slot through an entrance slot and manipulated by the user into a fixed slot, thereby fixing the RF puncture wire within the fixed slot.

[0009] Example 8 is the drilling system of Example 1, in which a long introducer may include multiple slots on a fixed hub. Example 9 is the puncture system of Example 1, wherein the puncture device is a nitinol radiofrequency guidewire.

[0010] Example 10 is the drilling system of Example 1, wherein the long introducer further includes a dilator. Example 11 is the puncture system of Example 1, in which the interlocking surfaces increase friction with the puncture device.

[0011] Example 12 is the puncture system of Example 1, wherein the interlocking surface is the inner surface of the slot that interlocks with the proximal portion of the puncture device. Example 13 is the puncture system of Example 1, in which the interlocking surface is the inner surface of a fixing slot that secures the puncture device.

[0012] Example 14 is the same puncture system as in Example 1, but the mating surfaces are made of a material with a high coefficient of friction in order to increase the frictional force between the mating surfaces and the puncture device. Example 15 is the puncture system of Example 1, which includes a surface finish that increases friction between the interlocking surfaces and the puncture device.

[0013] In Example 16, a radiofrequency puncture system for accessing a location within or near the patient's heart includes a radiofrequency puncture wire having a proximal wire portion and a distal wire portion including an electrically active distal tip. The radiofrequency puncture system also includes an elongated introducer that defines a lumen adapted to receive the radiofrequency puncture wire and allow its longitudinal movement, the elongated introducer having an introducer proximal portion and an introducer distal portion, the introducer proximal portion including a fixation hub, the fixation hub including a slot and the fixation hub including the fixation hub including the fixation hub configured to position the proximal wire portion within the slot and against the fixation hub, thereby generating a fixation friction force between the proximal wire portion and the fixation hub, the fixation friction force being sufficient to prevent longitudinal movement of the radiofrequency puncture wire relative to the elongated introducer.

[0014] Example 17 is the radiofrequency drilling system of Example 16, wherein the slot is a J-shaped opening. Example 18 is the radiofrequency drilling system of Example 17, wherein the slot further includes an entry slot.

[0015] Example 19 is the radiofrequency drilling system of Example 18, wherein the slots further include fixed slots. Example 20 is a radiofrequency drilling system of Example 19 in which the proximal end of the wire can be positioned in the entrance slot and bent toward the fixed slot.

[0016] Example 21 is a radiofrequency drilling system of Example 20 in which the proximal end of the wire is bent at approximately 45 to 90 degrees relative to the fixed hub. Example 22 is a radiofrequency drilling system of Example 16 in which a long introducer may include multiple slots on a fixed hub.

[0017] Example 23 is the radiofrequency drilling system of Example 16, wherein the radiofrequency drilling wire is a nitinol radiofrequency guidewire. Example 24 is the radiofrequency puncture system of Example 16, wherein the interlocking surface is the inner surface of the slot that interlocks with the proximal end of the RF puncture wire.

[0018] Example 25 is a radiofrequency drilling system of Example 16, in which the mating surfaces are made of a material with a high coefficient of friction in order to increase the frictional force between the mating surfaces and the RF drilling wire. In Example 26, a puncture system for epicardial or transseptal access includes a dilator having a dilator body and a tapered distal tip defining a dilator lumen; a puncture device having a proximal portion and a distal portion including the distal tip; and an elongated introducer defining a lumen adapted to receive the puncture device and allow its longitudinal movement, wherein the elongated introducer has an introducer proximal portion and an introducer distal portion, the introducer proximal portion including a fixing hub, the fixing hub including a slot and the fixing surface configured to allow the proximal portion to be positioned within the slot and against the fixing surface, thereby generating a fixing friction force between the proximal portion and the fixing surface, the fixing friction force being sufficient to prevent longitudinal movement of the puncture device relative to the elongated introducer.

[0019] Example 27 is the same drilling system as in Example 26, but with a J-shaped opening for the slot. Example 28 is the drilling system of Example 27, wherein the slot further includes an entry slot and a fixed slot.

[0020] Example 29 is a puncture system of Example 28, in which the proximal portion of the puncture device is inserted into the slot through an entrance slot and then manipulated by the user into a fixed slot, thereby fixing the puncture device within the fixed slot.

[0021] Example 30 is a drilling system of Example 29 in which the proximal portion is bent at approximately 45 to 90 degrees relative to the fixed hub. Example 31 is a drilling system of Example 26 in which a long introducer may include multiple slots on a fixed hub.

[0022] Example 32 is the puncture system of Example 26, wherein the puncture device is a radiofrequency puncture wire. Example 33 is the puncture system of Example 26, wherein the interlocking surface is the inner surface of the slot that interlocks with the proximal portion of the puncture device.

[0023] Example 34 is the piercing system of Example 26 where the mating surface is made of a material with a high coefficient of friction to increase the frictional force between the mating surface and the piercing device. In Example 35, a method of manufacturing a radio wave piercing system for accessing a location within or near a patient's heart includes providing a radio wave piercing wire having a wire proximal portion and a wire distal portion including an electrically active distal tip. The method of manufacturing a radio wave piercing system also includes advancing a long introducer defining a lumen adapted to receive the radio wave piercing wire and allow its longitudinal movement, the long introducer having an introducer proximal portion and an introducer distal portion, the introducer proximal portion including a fixed hub; the fixed hub including a slot and the mating surface configured to place the wire proximal portion within the slot and against the mating surface, whereby a fixed frictional force is generated between the wire proximal portion and the mating surface, the fixed frictional force being sufficient to prevent longitudinal movement of the radio wave piercing wire relative to the long introducer.

[0024] Although multiple embodiments are disclosed, still other embodiments of the invention will be apparent to those skilled in the art from the following detailed description which illustrates exemplary embodiments of the invention. Thus, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[0025] [Figure 1A] It is a schematic diagram of a medical procedure for accessing an intra-septal cavity within a patient's heart according to an embodiment of the present disclosure. [Figure 1B] It is a schematic diagram of a medical procedure for accessing an epicardial cavity within a patient's heart according to an embodiment of the present disclosure. [Figure 2] It is a perspective view of a radio wave piercing wire inserted into an introducer having a fixed hub according to an embodiment of the present disclosure. [Figure 3A]Figures 3A to 3E are partial perspective views and enlarged views of the fixing hub and radiofrequency puncture wire of Figure 2 according to embodiments of the present disclosure. [Figure 3B] Same as above. [Figure 3C] Same as above. [Figure 3D] Same as above. [Figure 3E] Same as above. [Modes for carrying out the invention]

[0026] While various modifications and alternative forms are possible with respect to the present invention, specific embodiments are shown as examples in the drawings and will be described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. On the contrary, the present invention is intended to encompass all modifications, equivalents, and alternatives that fall within the scope of the present invention as defined by the appended claims.

[0027] Detailed explanation Figures 1A and 1B are schematic diagrams of medical procedures for accessing the transseptal and epicardial spaces within a patient's heart according to embodiments of the present disclosure. Figure 1A shows a medical procedure 10 within a patient's heart 20 using a transseptal access system 50. As is well 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. The atrial septum 75 separates the right atrium 55 from the left atrium 60, and the ventricular septum 80 separates the right ventricle 65 from the left ventricle 70. As is also known, deoxygenated blood from the patient's body is returned to the right atrium 55 via the inferior vena cava (IVC) 85 or the superior vena cava (SVC) 90.

[0028] Various medical procedures have been developed to diagnose or treat physiological conditions occurring within the left atrium 60 and related structures. Examples of such procedures include, but are not limited to, the placement of a diagnostic or mapping catheter within the left atrium 60 to generate an electroanatomical map or diagnostic image thereof. Other exemplary procedures include endocardial catheter-based ablation of a target site within the cardiac chamber or adjacent vessels (e.g., pulmonary veins and their venous orifices) to cessate cardiac arrhythmias such as atrial fibrillation and atrial flutter (e.g., radiofrequency ablation, pulsed-field ablation, cryoablation, laser ablation, radiofrequency ultrasound ablation, etc.). Yet another exemplary procedure is the placement of a left atrial appendage (LAA) closure device. However, the foregoing examples of procedures within the left atrium 60 are merely illustrative and do not limit the scope of this disclosure.

[0029] In procedures providing access to the left atrium 60, a transseptal access system and devices are used to subsequently deploy the aforementioned diagnostic and / or therapeutic devices into the left atrium 60. In these procedures, the extent of the target tissue site can be defined by the tissue on the atrial septum 75. The target site is accessed, for example, through the femoral vein and via the inferior vena cava (IVC) 85 according to conventional catheter insertion techniques. In other embodiments, access to the target site on the atrial septum 75 can be achieved using an upper approach, which involves advancing the transseptal access system 50 into the right atrium 55 via the superior vena cava (SVC) 90.

[0030] Transseptal access system procedures may include many devices, such as an introducer sheath 100, a dilator 105, a puncture device having a distal end 112 ending with a tip 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. The puncture device 110 may also be located within the dilator 105, and the dilator 105 itself may be located within the sheath 100. In one embodiment in which the transseptal access system 50 is deployed into the right atrium 55 via the IVC 85, the user introduces a guidewire (not shown) into the femoral vein, typically the right femoral vein, and advances it toward the heart 20. Next, the sheath 100 is introduced into the femoral vein along the guidewire and advanced toward the heart 20. In one embodiment, the distal ends of the guidewire and sheath 100 are located within the SVC 90. These steps may be performed with the help of imaging systems such as fluoroscopy or ultrasound imaging. Next, the dilator can be inserted into the sheath along the guidewire and advanced through the sheath to the SVC. Alternatively, the dilator can be fully inserted into the sheath before insertion into the body, allowing both to be advanced towards the heart simultaneously.

[0031] Once the guidewire, sheath 100, and dilator 105 are positioned within the SVC 90, the guidewire is removed from the body and the sheath 100 and dilator 105 are withdrawn so that their distal ends are positioned within the right atrium 55. The puncture device 110 described above can then be introduced into the dilator 105 and advanced toward the heart 20. The puncture device 110 is then positioned so that the tip electrode 115 is aligned with or slightly protruding from the distal end of the dilator 105. In embodiments where the puncture device 110 is an RF puncture device, with the tip electrode 115 and dilator 105 positioned at the target site, energy is delivered from an energy source, such as an RF generator, through the RF puncture device 110 to the tip electrode 115 and the target site. In some embodiments, the energy is delivered with a voltage of at least about 75V (peak-to-peak) and a power of at least about 5W, which functions to create a void or perforation in the tissue of the target site by vaporizing cells near the tip electrode. Next, the user applies force to the RF piercing device 110 to advance the tip electrode 115 at least partially through the piercing. In these embodiments, energy delivery is stopped once the tip electrode 115 has passed through the target tissue, i.e., reached the left atrium 60. In some embodiments, the energy delivery step is performed over a period of about 1 second to about 5 seconds.

[0032] Another medical procedure 10 developed to diagnose or treat physiological pathologies occurring within the heart 20 includes epicardial ablation to restore a regular heart rhythm, as shown in Figure 1B. As illustrated, the heart 20 includes the pericardium 40, the pericardial cavity 42, and the myocardium 44. Access to the heart 20 is usually performed using a subxiphoid approach. Access to the epicardium is achieved by puncturing the layer of the pericardium 40 while avoiding the myocardium 44 of the heart. The pericardium 40 is a double-walled, tough fibrous elastic sac that surrounds the heart 20 and the base of the great blood vessels. The pericardium 40 has two layers: the outer layer is made of strong connective tissue, also called the fibrous pericardium, and the inner layer is made of serosal tissue, also called the serous pericardium. The mesothelium or mesothelial cells that make up the serous pericardium also cover the cardiac myocardium as the epicardium, resulting in continuous serosal invagination as two opposing surfaces, such as over the fibrous pericardium 40 and over the heart 20. This creates a sac-like virtual or potential space around the heart 20, surrounded by the two opposing serosal surfaces, which is also called the pericardial space or pericardial cavity 42.

[0033] In some embodiments, the pericardium 40 can be punctured with a puncture device 110, such as a needle (or other mechanical puncture device). After puncture, the puncture site created by the needle is expanded through the pericardium 40 by advancing a dilator 105. In certain embodiments, the sheath 100 may be advanced simultaneously with the dilator 105. In other embodiments, the sheath 100 may be advanced afterward. The sheath 100 and dilator 105 can then be withdrawn, leaving the guidewire 104 in the pericardial cavity 42. Minimally invasive access to the epicardium is necessary for the diagnosis and treatment of various arrhythmias and other conditions. Epicardial ablation creates a transmural wound by making a small incision on the outside of the heart. In other words, it ablates tissue by penetrating the thick muscle of the heart.

[0034] This disclosure describes novel devices and methods for providing safe access to the heart, specifically transseptal and epicardial access, using radiofrequency energy. As described in more detail herein, embodiments of this disclosure simplify the means of puncturing the heart, provide a mechanism to ensure that the tip electrode of a guidewire remains securely in place, and improve user operability.

[0035] Figure 2 is a perspective view of a puncture device 240 inserted into a long introducer 210 to access a target region within a patient's heart, according to an embodiment of the present disclosure. Hereinafter referred to as an RF puncture wire, in various embodiments the puncture device 240 is a mechanical puncture device (e.g., a needle). As shown, the RF puncture wire 240 includes a proximal wire portion 246 and a distal wire portion 214 terminated at an electrically active distal tip electrode 242. Furthermore, as shown, the long introducer 210 defines a lumen and includes a proximal introducer portion 216 and a distal introducer portion 214. The introducer lumen (not shown) extends longitudinally through the introducer 210 from the proximal introducer portion 216 to the distal introducer portion 214. The introducer 210 serves to receive the RF puncture wire 240 and allow its longitudinal movement. As shown in the figure, the fixing hub 220 is connected to the nearest end of the introducer proximal section 216. In some embodiments, the fixing hub 220 may include a tapered distal section and be configured to connect to an auxiliary device. In the illustrated embodiment, a rigid sheath 215 defining the lumen is connected to the distal end of the fixing hub 220. In some embodiments, as shown in Figure 2, a dilator 217 may be connected to the distal end of the sheath 215. As shown in Figure 2, the RF puncture wire 240 may be inserted into the introducer proximal section 216 of the introducer 210 via the fixing hub 220 and exit from the introducer distal section 214.

[0036] In some embodiments, the introducer 210 may also include a side tube 230 connected to a stopcock supply valve 235. The introducer 210 stopcock 235 can be connected to at least one inlet line of the introducer 210 and, by further connection to a fluid source, can provide an operable delivery interface from the fluid source to the introducer 210. In one embodiment, access to the RF puncture wire 240 can be confirmed by delivering a contrast agent / medium into space. In one embodiment, the user can know the location of the RF puncture wire 240 by how the contrast agent is depicted under fluoroscopy. In one embodiment, the contrast agent includes, but is not limited to, iodine-based contrast agents, gadolinium-based contrast agents, microbubble contrast agents, iron oxide nanoparticles, etc. In some embodiments, the sheath 215 is preferably a tubular member having a substantially uniform outer shape at the proximal end of the sheath 215. In certain embodiments, the sheath 215 may further have a distal taper that tapers at the distal portion 214 of the introducer. In some embodiments, the dilator 217 may further include a distal taper that narrows at the distal portion 214 of the introducer. In some embodiments, the introducer 210 may be used without the dilator 217.

[0037] Figures 3A–3E are partial perspective and enlarged views of an introducer 310 having a proximal portion 316 according to embodiments of the present disclosure. The introducer 310 in Figures 3A–3E is functionally and structurally similar to the introducer 210 in Figure 2. The introducer 310 includes a fixed hub 320 having a distal taper that defines a lumen (not shown) and connects to a sheath 315. The introducer lumen extends longitudinally through the introducer 310. As shown in Figure 3B, the introducer 310, and therefore the fixed hub 320, serve to receive the RF puncture wire 340 and allow its longitudinal movement. As shown in Figures 3B and 3C, in certain embodiments, the fixed hub 320 operates to hold the proximal portion 346 of the RF puncture wire 340 in place. The fixing hub 320 includes a mating surface 321 and a J-shaped slot 322 having an entry slot 324 and a fixing slot 326. In certain embodiments, as shown in Figures 3B and 3C, the mating surface 321 includes the inner surface of the slot 322 and is the entire region within the fixing hub 320 that mates with the proximal portion 346 of the RF puncture wire 340 when the RF puncture wire 340 is inserted into the fixing hub 320. In other embodiments, the mating surface 321 is the inner surface of the fixing slot 326 above the slot 322, which secures the RF puncture wire 340.

[0038] As shown in Figure 3B, during use, the proximal end 346 of the RF puncture wire 340 is inserted into the J-shaped slot 322 via the entrance slot 324, and then the RF puncture wire 340 is fixed therein by being operated by the user and inserted into the fixed slot 326. In some embodiments, the slot 322 and the interlocking surface 321 of the fixed hub 320 are configured such that when the proximal end 324 of the RF puncture wire is positioned in the slot 322 and strikes the interlocking surface, a fixing friction force is generated between the proximal end 346 of the wire and the interlocking surface 321. In some embodiments, the fixing friction force is sufficient to prevent longitudinal movement of the RF puncture wire 340 relative to the elongated introducer 310. As shown in Figure 3D, when the RF puncture wire 340 is inserted into the fixed hub 320, the RF puncture wire is in a first initial unlocked position. As described above and as shown in Figure 3E, when the RF puncture wire 340 is moved into the fixed slot 326, it enters a second locked position. Therefore, in some embodiments, the contact points between the RF puncture wire 340 and the fixed hub 320 are the contact point 323 at the bottom of the J-shaped slot 322 and the contact point 325 on the upper surface of the fixed slot 326 when the RF puncture wire is in the locked position.

[0039] In certain embodiments, the slot 322 secures the distal end of the RF puncture wire 340, and therefore the active tip electrode, in a predetermined position relative to the introducer, thereby ensuring accurate and repeatable puncture to the target tissue as needed. Thus, any opposing force from the introducer acting on the RF puncture wire 340 is counteracted by the locking mechanism of the fixing hub 320, allowing the tip electrode of the RF puncture wire 340 to maintain an ideal position relative to the introducer 310. In some embodiments, the RF puncture wire 340 includes an appropriate combination of rigidity, the angle at which it is hooked and secured, and a sufficient distance between the slot and where the wire exits the introducer. In some embodiments, the interlocking surface 321 is made of a material with a high coefficient of friction to increase the frictional force between the interlocking surface 321 and the RF puncture wire 340. In one embodiment, the increased frictional force may be provided on the introducer hub. In other embodiments, the increased frictional force may be provided at specific locations along the puncture wire 340. In these embodiments, the mating surfaces 321 may be made from polyurethane, which is known to have excellent friction properties; acrylonitrile butadiene styrene (ABS), a thermoplastic resin known to have high strength and durability; polycarbonate, a transparent and impact-resistant plastic that can be modified to enhance friction properties; or polypropylene, a versatile and cost-effective plastic used in a wide range of medical applications.

[0040] Similarly, in some embodiments, the interlocking surface 321 includes a surface finish (e.g., texture) that facilitates friction with the RF puncture wire. In these embodiments, the interlocking surface 321 may have a textured or rough surface. Adding texture to the plastic or creating a rough surface can increase friction. This can be achieved by methods such as embossing, etching, or the use of abrasives during the molding process. Depending on the required level of friction, the texture can range from fine to coarse. In other embodiments, the interlocking surface 321 may include a microstructured surface, which involves creating a fine pattern or feature on the plastic surface. These microstructures (such as grooves or ridges) can increase the contact area between the surface and the object in contact, thus improving friction. In yet another embodiment, the interlocking surface 321 may have a matte or stained finish, which provides a certain level of friction. These finishes have a slightly rougher texture compared to a glossy finish and can enhance grip and friction. In yet another embodiment, the interlocking surface 321 may include surface treatments such as corona treatment or plasma treatment that can modify the surface properties of the plastic. These processes can increase surface energy and improve adhesion to other materials. This can indirectly affect friction by influencing the interaction between the surface and objects in contact. In various embodiments, the interlocking surfaces may be located on a portion of the RF wire, in addition to or instead of an interlocking surface located on the introducer hub.

[0041] In some embodiments, once the RF puncture wire 340 is hooked and secured (see Figure 3E), the wire bends at an angle of approximately 10 to 60 degrees relative to the fixing hub 320. In certain embodiments, the RF wire 340 bends at an angle of approximately 20 to 50 degrees relative to the fixing hub 320. In some embodiments, the RF puncture wire 340 may be made of nitinol RF guidewire to allow for the flexibility required for bending and the rigidity required to maintain its position within the fixing hub 320. In further embodiments, the introducer 310 can be provided with a plurality of slots 322 on the fixing hub 320 to ensure further stability of the RF puncture wire 340.

[0042] In one embodiment, the puncture wire 340 may include line markers positioned at specific locations on the puncture wire 340. In some embodiments, the line markers on the puncture wire 340 can indicate the position of the fixed puncture wire 340. In one embodiment, the line markers may be made of heat-shrinkable material. In some embodiments, each line marker is separated by a specific distance from other line markers so that the user can accurately indicate the position where the puncture wire 340 is fixed and the amount of puncture wire 340 inserted.

[0043] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to certain features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the features described. Accordingly, the scope of the invention is intended to encompass all alternatives, modifications, and changes included in the claims, along with all their equivalents.

Claims

1. A perforation system for accessing a location inside or near the heart of a patient, wherein the system is A puncture device having a proximal portion of the puncture device and a distal portion of the puncture device including a distal tip, A long introducer defining a lumen adapted to receive the puncture device and allow its longitudinal movement, wherein the long introducer has a proximal introducer portion and a distal introducer portion, the proximal introducer portion including a fixing hub, and Includes, A puncture system in which the fixing hub includes a slot and a mating surface configured to allow the proximal portion of the puncture device to be positioned within the slot and in contact with the mating surface, thereby generating a fixing friction force between the proximal portion of the puncture device and the mating surface, the fixing friction force being sufficient to prevent the longitudinal movement of the puncture device relative to the elongated introducer.

2. The drilling system according to claim 1, wherein the slot is a J-shaped opening.

3. The drilling system according to claim 1 or 2, wherein the slot further includes an entrance slot.

4. The drilling system according to any one of claims 1 to 3, wherein the slot further includes a fixed slot.

5. The puncture system according to any one of claims 1 to 4, wherein the proximal portion of the puncture device can be positioned in the entrance slot and can be further bent toward the fixed slot.

6. The puncture system according to any one of claims 1 to 5, wherein the proximal portion of the puncture device is bent at an angle of approximately 45 to 90 degrees relative to the fixed hub.

7. The puncture system according to any one of claims 1 to 5, wherein the puncture device is an RF puncture wire having an electrically active distal tip, the proximal portion of the RF puncture wire is inserted into the slot through the entrance slot, and the RF puncture wire is fixed in the fixing slot by being manipulated by the user into the fixing slot.

8. The drilling system according to claim 1, wherein the elongated introducer may include a plurality of slots on the fixed hub.

9. The puncture system according to claim 1, wherein the puncture device is a nitinol radiofrequency guidewire, and the puncture device includes at least one line marker along the elongated body of the puncture device.

10. The drilling system according to claim 1, wherein the elongated introducer further includes a dilator.

11. The puncture system according to claim 1, wherein the interlocking surfaces increase friction with the puncture device.

12. The puncture system according to claim 1, wherein the engaging surface is the inner surface of the slot that engages with the proximal portion of the puncture device.

13. The puncture system according to claim 1, wherein the interlocking surface is the inner surface of the fixing slot for fixing the puncture device.

14. The puncture system according to claim 1, wherein the interlocking surfaces are made of a material with a high coefficient of friction in order to increase the frictional force between the interlocking surfaces and the puncture device.

15. The puncture system according to claim 1, wherein the interlocking surfaces include a surface finish that increases friction with the puncture device.

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