Distal tip port opening

Abstract

A high-frequency drilling device is disclosed. The device includes an elongated member defining a lumen, the elongated member extending from a proximal portion including a hub to a distal portion including a distal tip electrode and a slot having a distal surface defining a distal opening. The device also includes an outer insulating layer covering a portion of the outer surface of the elongated member but not covering the distal tip electrode. Finally, the device includes an inner insulating layer covering at least the distal portion of the lumen.

Description

Technical Field

[0001] The present invention generally relates to methods and devices that can be used to deliver energy into a patient's body. More particularly, the present invention relates to a high-frequency perforation device.

Background Art

[0002] Currently, there are devices for creating punctures, channels, or perforations within tissue located within a patient's body. One such device is the Brockenbrough (trademark) needle, which is commonly used to puncture the atrial septum of the heart. This device is a rigid, elongated needle that is introduced into the patient's body via the femoral vein and is configured to be directed towards the heart. This device relies on the use of mechanical force to pass the sharp tip through the septum.

[0003] Alternatively, there are also currently devices for access to the epicardial space. Access to the space can be initiated using a mechanical puncture device using a large-bore needle such as a Tuohy-type needle. These needles for accessing the epicardial space are associated with a high clinical complication rate. In addition, the design of epicardial access needles typically includes a lateral port and does not include an anterior-facing lumen opening. Devices having an anterior-facing opening are generally superior to lateral port devices in facilitating the use of a guidewire.

[0004] In view of this background, there has been a continuing need in the industry to provide improved high-frequency perforation devices and methods for accessing the epicardial and transseptal spaces. Accordingly, an object of the present invention is to provide such a high-frequency perforation device.

Summary of the Invention

[0005] In Example 1, the high-frequency drilling device includes an elongated member defining a lumen, extending from a proximal portion including a hub to a distal portion including a distal tip electrode having a distal surface defining a distal opening and a slot. The high-frequency drilling device also includes an outer insulating layer covering a portion of the outer surface of the elongated member but not covering the distal tip electrode. The high-frequency drilling device further includes an inner insulating layer covering at least the distal portion of the lumen.

[0006] Example 2 is the same high-frequency drilling device as in Example 1, but with a distal surface that forms a C-shaped electrode profile. Example 3 is a high-frequency drilling device of either Example 1 or 2, in which a C-shaped electrode is fitted to form a C-shaped incision in the tissue of the target site.

[0007] Example 4 is a high-frequency drilling device of Example 1, in which the inner insulating layer extends through the slot and bonds to the outer insulating layer. Example 5 is a high-frequency drilling device according to any of Examples 1-3, wherein a C-shaped electrode profile is formed by the inner insulating layer extending beneath the outer insulating portion.

[0008] Example 6 is the high-frequency drilling device of Example 1, in which fluorinated ethylene propylene (FEP) is placed in the slot between the inner insulating layer and the outer insulating layer. Example 7 is a high-frequency drilling device of Example 1 in which the inner insulating layer and the outer insulating layer extend within the slot and are bonded within the slot.

[0009] Example 8 is the same high-frequency drilling device as in Example 1, but with a dome-shaped tip for the distal electrode. Example 9 is the same high-frequency drilling device as in Example 1, but with a beveled tip for the distal electrode. Example 10 is the high-frequency drilling device of Example 1, wherein the outer insulating layer is formed from a heat-shrinkable material.

[0010] Example 11 is the high-frequency drilling device of Example 1, wherein the inner insulator is formed from fluorinated ethylene propylene (FEP). Example 12 is the same high-frequency drilling device as in Example 1, but with a port opening where the distal opening faces forward.

[0011] Example 13 is a high-frequency drilling device of any of Examples 1-12, in which a forward-facing port opening facilitates the use of guide wires on the device. Example 14 is a high-frequency drilling device of any of Examples 1-13, wherein the C-shaped electrode profile is larger at the top of the electrode tip.

[0012] Example 15 is a radiofrequency drilling device of Example 1, wherein the distal portion is conductive and capable of transmitting radiofrequency energy supplied by an external RF generator to the distal tip electrode, and then delivering it to target tissue.

[0013] In Example 16, the high-frequency drilling device includes an elongated member defining a lumen, extending from a proximal portion including a hub to a distal portion including a distal tip electrode having a distal surface defining a distal opening and a slot. The high-frequency drilling device also includes an outer insulating layer covering a portion of the outer surface of the elongated member but not covering the distal tip electrode. The high-frequency drilling device further includes an inner insulating layer covering at least the distal portion of the lumen.

[0014] Example 17 is the high-frequency drilling device of Example 16, wherein the distal surface forms a C-shaped electrode profile. Example 18 is a radiofrequency drilling device of Example 17, in which a C-shaped electrode is fitted to form a C-shaped incision in the tissue of the target site.

[0015] Example 19 is a high-frequency drilling device of Example 16 in which the inner insulating layer extends through the slot and bonds to the outer insulating layer. Example 20 is a high-frequency drilling device of Example 19 in which a C-shaped electrode profile is formed by the inner insulating layer extending beneath the outer insulating portion.

[0016] Example 21 is the high-frequency drilling device of Example 16, in which fluorinated ethylene propylene (FEP) is placed in the slot between the inner and outer insulating layers. Example 22 is a high-frequency drilling device of Example 16 in which the inner and outer insulating layers extend within the slot and are bonded within the slot.

[0017] Example 23 is the high-frequency drilling device of Example 16, wherein the outer insulating layer is formed from a heat-shrinkable material. Example 24 is the high-frequency drilling device of Example 16, wherein the inner insulator is formed from fluorinated ethylene propylene (FEP).

[0018] Example 25 is a high-frequency drilling device of Example 16, in which the distal opening is a port opening facing forward. In Example 26, the epicardial or transseptal transverse system includes a dilator having a dilator body defining a dilator lumen and a tapered distal tip. The transverse system includes an elongated member defining the lumen, which extends from a proximal portion including a hub to a distal portion including a distal tip electrode having a distal surface defining a distal opening and a slot. The transverse system further includes an inner insulating layer covering at least the distal portion of the lumen, and the elongated member is adapted to advance through the dilator lumen and deliver RF energy to the distal tip electrode.

[0019] Example 27 is a transverse system of Example 26 in which the distal surface forms a C-shaped electrode profile. Example 28 is a transverse system of Example 27 in which a C-shaped electrode is fitted to form a C-shaped incision in the tissue of the target site.

[0020] Example 29 is a transverse system of Example 26 in which the inner insulating layer extends through the slot and bonds to the outer insulating layer. Example 30 is a transverse system of Example 29 in which a C-shaped electrode profile is formed by the inner insulating layer extending beneath the outer insulating portion.

[0021] Example 31 is the cross-sectional system of Example 26 in which fluorinated ethylene propylene (FEP) is disposed within a slot between an inner insulating layer and an outer insulating layer. Example 32 is the cross-sectional system of Example 26 in which an inner insulating layer and an outer insulating layer extend into and are joined within a slot.

[0022] Example 33 is the cross-sectional system of Example 26 in which the distal tip electrode is a dome-shaped tip. Example 34 is the cross-sectional system of Example 26 in which the distal tip electrode is a bevel-shaped tip. Example 35 is a method of epicardial or transseptal crossing. The method includes providing an elongate member defining a lumen and extending from a proximal portion including a hub to a distal portion including a distal tip electrode having a distal face defining a distal opening and a slot. The method also includes advancing the elongate member into a patient's heart such that the distal tip electrode contacts the septum of the heart. The method further includes supplying RF energy to the distal electrode such that the distal electrode penetrates the septum and enters the left atrium of the heart.

[0023] Although multiple embodiments are disclosed, further embodiments of the present invention will become apparent to those of ordinary skill in the art from the following detailed description which illustrates and describes exemplary embodiments of the invention. The drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[0024] [Figure 1A] Figures 1A - 1D are schematic diagrams showing medical procedures within a patient's heart to gain access to the transseptal and epicardial spaces, according to embodiments of the present disclosure. [Figure 1B] Figures 1A - 1D are schematic diagrams showing medical procedures within a patient's heart to gain access to the transseptal and epicardial spaces, according to embodiments of the present disclosure. [Figure 1C] Figures 1A - 1D are schematic diagrams showing medical procedures within a patient's heart to gain access to the transseptal and epicardial spaces, according to embodiments of the present disclosure. [Figure 1D] Figures 1A to 1D are schematic diagrams illustrating intracardiac medical procedures in a patient to obtain access to the transseptal and epicardial spaces according to embodiments of the present disclosure. [Figure 2] Figure 2 is a schematic diagram of the dilator and high-frequency drilling device of the transseptal access system shown in Figures 1A to 1D, according to an embodiment of the present disclosure. [Figure 3A] Figures 3A to 3C are schematic diagrams of the distal end portion of a high-frequency drilling device having an insulated distal tip port opening according to an embodiment of the present disclosure. [Figure 3B] Figures 3A to 3C are schematic diagrams of the distal end portion of a high-frequency drilling device having an insulated distal tip port opening according to an embodiment of the present disclosure. [Figure 3C] Figures 3A to 3C are schematic diagrams of the distal end portion of a high-frequency drilling device having an insulated distal tip port opening according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0025] The present invention follows various modifications and alternative forms, but specific embodiments are shown in the drawings as examples and are described in detail below. However, the intent 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 invention as defined by the appended claims.

[0026] Figures 1A to 1D are schematic diagrams illustrating an intracardiac medical procedure in a patient's heart to obtain access to the transseptal and epicardial spaces according to embodiments of the present disclosure. Figures 1A to 1C illustrate a medical procedure 10 in a patient's heart 20 using a transseptal access 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. The right atrium 55 and the left atrium 60 are separated by the atrial septum 75, and the right ventricle 65 and the left ventricle 70 are separated by the ventricular septum 80. 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.

[0027] Various medical procedures have been developed to diagnose or treat physiological disorders occurring within the left atrium 60 and associated structures. Exemplary procedures include, but are not limited to, the placement of diagnostic or mapping catheters within the left atrium 60 for use in generating electroanatomical maps or diagnostic images. Other exemplary procedures include endocardial catheter-based ablation (e.g., radiofrequency ablation, pulsed field ablation, cryoablation, laser ablation, radiofrequency ultrasound ablation, etc.) of target sites within cardiac chambers or adjacent vessels (e.g., pulmonary veins and their orifices) to terminate cardiac arrhythmias such as atrial fibrillation and atrial flutter. Further exemplary procedures may include the placement of left atrial appendage (LAA) closure devices. Naturally, the foregoing examples of procedures within the left atrium 60 are illustrative and do not limit this disclosure in any way.

[0028] The medical procedure 10 shown in Figures 1A to 1C is an exemplary embodiment for providing access to the left atrium 60 using a transseptal access system 50, and then positioning the aforementioned diagnostic and / or therapeutic device within the left atrium 60. As shown in Figures 1A to 1C, the target tissue site may be defined by tissue on the atrial septum 75. In the illustrated embodiment, the target site is accessed, for example, via the IVC 85 through the femoral vein, according to conventional catheter insertion techniques. In other embodiments, access to the target site on the atrial septum 75 may be achieved using a superior approach in which the transseptal access system 50 is advanced into the right atrium 55 via the SVC 90.

[0029] In the illustrated embodiment, the transseptal access system 50 includes an introducer sheath 100, a dilator 105 having a dilator body 107 and a tapered distal tip portion 108, and a radio frequency (RF) puncture device 110 having a distal end portion 112 terminated at a tip electrode 115. As shown, in the assembled and used state shown in Figures 1A-1C, the RF puncture device 110 can be placed inside the dilator 105, and the dilator 105 itself can be placed inside the sheath 100. In one embodiment in which the transseptal access system 50 is placed inside 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. The sheath 100 can then be introduced into the femoral vein on the guidewire and advanced toward the heart 20. In one embodiment, the guidewire and the distal end of the sheath 100 are then placed inside the SVC 90. These steps may be performed using an imaging system, such as fluoroscopy or ultrasound imaging. The dilator 105 is then introduced into the sheath 100 and advanced into the SVC 90 through the sheath 100 along the guidewire. Alternatively, the dilator 105 may be fully inserted into the sheath 100 before entering the body, and both may be advanced simultaneously toward the heart 20. 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 retracted so that their distal ends are positioned within the right atrium 55. The RF puncture device 110 described above can then be introduced into the dilator 105 and advanced toward the heart 20. In certain embodiments, the dilator may be introduced into the body without the need for the sheath 100.

[0030] Next, the user may bring the distal end of the dilator 105 into contact with the atrial septum 75, which may be done under imaging guidance. The RF puncture device 110 is then positioned so that its tip electrode 115 is aligned with the distal end of the dilator 105 or slightly protruding from the distal end of the dilator 105. The dilator 105 and RF puncture device 110 are dragged along the atrial septum 75 and may be brought into contact with, for example, the fossa ovale of the atrial septum 75 under imaging guidance. Various additional steps may be performed, such as measuring one or more properties of the target site, e.g., electrographic or ECG (electrocardiogram) tracing and / or pressure measurement, or delivering material to the target site, e.g., delivering a contrast agent. Such steps can facilitate the positioning of the tip electrode 115 at the desired target site. In addition, tactile feedback provided by the medical RF puncture device 110 can be used to facilitate the positioning of the tip electrode 115 at the desired target site.

[0031] 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, to the tip electrode 115 and the target site through an RF perforation device 110. 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 vaporize cells in the vicinity of the tip electrode 115, thereby creating a void or perforation through the tissue of the target site. The user then applies force to the RF perforation device 110 to advance the tip electrode 115 at least partially through the perforation. In these embodiments, energy delivery is stopped when the tip electrode 115 has passed through the target tissue, i.e., when it has reached the left atrium 60. In some embodiments, the energy delivery process takes place over a period of time between about 1 second and about 5 seconds.

[0032] With the tip electrode 115 of the RF perforation device 110 traversing the atrial septum 75, the dilator 105 can be advanced forward, and the tapered distal tip portion 108 operates to gradually enlarge the perforation, allowing the distal end of the sheath 100 to advance into the left atrium 60.

[0033] In some embodiments, the distal end portion 112 of the RF puncture device 110 may be pre-formed to take a non-traumatic shape, such as a J-shape, a pigtail shape, or other shape selected to orient the tip electrode 115 away from the endocardial surface of the left atrium 60. Examples of such RF puncture devices can be found, for example, in U.S. Patent Applications 16 / 445,790 and 16 / 346,404, assigned to Baylis Medical Company, Inc. The aforementioned pre-formed shapes can advantageously serve to minimize the risk of unintended contact between the tip electrode 115 and tissue within the left atrium 60, and can also act to anchor the distal end portion 112 within the left atrium 60 during subsequent treatment steps. For example, in some embodiments, the RF puncture device 110 may be structurally configured to function as a delivery rail for positioning a relatively large-bore therapeutic delivery sheath and associated dilators. In such embodiments, the dilator 105 and sheath 100 are withdrawn after the distal end portion 112 of the RF perforation device 110 has been positioned in the left atrium 60. The pre-formed anchoring function of the distal end portion 112 prevents unintended retraction of the distal end portion 112 and loss of access to the perforated site on the corresponding atrial septum 75 during such withdrawal.

[0034] As shown in Figure 1D, yet another medical procedure 10 developed to diagnose or treat physiological disorders occurring within the heart 20 includes epicardial ablation to help restore a regular heart rhythm. As illustrated, the heart includes the pericardium 40, the pericardial cavity 42, and the myocardium 44. The heart 20 is typically approached using a subxiphoid approach. Access to the epicardium is achieved by puncturing a layer of the pericardium 40 while avoiding the myocardium 44 of the heart. The pericardium 40 is a tough, double-walled fibrous elastic sac surrounding the heart 20 and the roots of the great blood vessels. The pericardium 40 consists of two layers: an outer layer made of tough connective tissue, often called the fibrous pericardium, and an inner layer made of serous membrane, often 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 a continuous serosal membrane that invaginates itself as two opposing surfaces, such as on the fibrous pericardium 40 and on the heart 20. This forms a pouch-like virtual or latent space around the heart surrounded between the two opposing serosal surfaces, which is often called the pericardial space or pericardial cavity 42.

[0035] In some embodiments, the pericardium 40 can be punctured with a needle. Once punctured, the dilator 105 is advanced to expand the puncture created by the needle through the pericardium 40. In some embodiments, the sheath 100 may be advanced together with the dilator 105. In other embodiments, the sheath 100 may be advanced afterward. The sheath 100 and dilator 105 are then withdrawn, leaving the guidewire 104 in the pericardial cavity 42. Minimally invasive access to the epicardium is required for the diagnosis and treatment of various arrhythmias and other conditions. During epicardial ablation, small scars are formed on the outside of the heart, forming damage that penetrates the wall. In other words, it forms cauterized tissue that penetrates the thick muscle of the heart.

[0036] This disclosure describes novel devices and methods for providing safe access to the heart, specifically transseptal and epicardial access, using radiofrequency energy. As will be described in further detail herein, embodiments of this disclosure simplify the means of puncturing the heart while preventing the possibility of coring and improving user operability.

[0037] Figure 2 shows a dilator 205 and an RF drilling device 210 according to one embodiment of the present disclosure. As shown, the dilator 205 includes a dilator body 220, a dilator hub 224, and a dilator lumen 230 extending longitudinally through the hub 224 and the dilator body 220. In addition, the dilator body 220 has a proximal end portion 221 and an opposite distal end portion 222 terminating at a distal tip 246. The hub 224 is attached to the proximal end portion 221 of the dilator body 220. Although the drilling device in Figure 2 is described as a high-frequency drilling device, in some embodiments the drilling device may be a mechanical drilling device.

[0038] As can be seen further from Figure 2, the RF puncture device 210 includes a proximal portion 260 and a distal portion 266 extending from the proximal portion 260 and terminating at a distal functional tip 270 (e.g., the tip electrode described above in relation to Figures 1A-1C). As can be understood, the length of the RF puncture device 210 is greater than the length of the dilator 205, and as a result, when the distal portion 266, in particular the functional tip 270, extends distal to the dilator 205, a portion of the proximal portion 260 of the RF puncture device 210 extends proximal to the hub 224, thus allowing the proximal portion 260 to be manipulated by the user as needed.

[0039] In some embodiments, the proximal portion 260 of the RF drilling device 210 has an electrically insulated outer surface. Therefore, even when the RF drilling device 210 is energized, the proximal portion 260 can be directly handled by the user. In some embodiments, the proximal portion 260 has a monolithic structure formed entirely of an electrically insulating material. One exemplary class of materials for the construction of the proximal portion can include, among other things, various grades of polytetrafluoroethylene (PTFE) and polyetheretherketone (PEEK). In some embodiments, the proximal portion 260 further includes reinforcing elements, such as polymer braids or coils, which can improve structural properties, such as rigidity, torque transmission capability, etc. In some embodiments, the proximal portion is formed from a metal (e.g., a metal hypotube) and includes an outer electrically insulating layer.

[0040] In the illustrated embodiment, the distal portion 266 is conductive and can transmit high-frequency energy supplied by an external RF generator to the functional tip 270, which can then be subsequently delivered to the target tissue in transseptal or epicardial ablation procedures as described above. Any biocompatible conductive material can be selected for the construction of the distal portion 266. Exemplary materials may include stainless steel, nickel-titanium alloy, and the like. Furthermore, for ease of explanation, in Figure 2 the distal portion 266 is depicted as a single solid structure, but the structure of the distal portion 266 can be modified to adapt to the specific structural requirements of the RF piercing device 210, as will be further described below. For example, in some embodiments, the distal portion 266 may be configured as a solid rod, tube, or coil.

[0041] In addition, in some embodiments, the distal portion 266 can be constructed of multiple segments, for example, a solid rod or hypo tube in the region closest to the proximal portion 260 and a coiled structure further distally, which can improve flexibility and torque transmission. In some embodiments, the distal portion can have a composite structure, for example, a solid or tubular core conductor surrounded by a wire coil. In addition, in the illustrated embodiments, the proximal portion 260 and the distal portion 266 are substantially of equal diameter, but this is not a strict requirement in all embodiments.

[0042] Figures 3A to 3C are schematic diagrams of the distal end portion 366 of an RF drilling device terminating at a distal tip 320 having a distal surface, according to embodiments of the present disclosure. The RF drilling devices of Figures 3A to 3C may be substantially structurally and functionally identical to the RF drilling devices of Figures 1A to 1D and 2, except in respects described in relation to Figures 3A to 3C. The RF drilling device includes an elongated member defining a lumen, the elongated member extending from a proximal portion including a hub to the distal portion 366, as shown in Figure 2. As shown, the distal portion 366 of the RF drilling device includes a distal tip electrode 315 having a distal surface defining a distal opening 305. In some embodiments, the distal portion 366 also includes a slot 325, as shown in Figures 3B to 3C. As shown in Figures 3A to 3C, the RF drilling device further includes an outer insulating layer 321 that covers a portion of the outer surface of the elongated member but does not cover the distal tip electrode 315. In addition, as shown, the RF drilling device includes an inner insulating layer 322 that covers the distal portion 366 of the lumen. In some embodiments, the inner insulating layer 322 extends along part or all of the length of the RF drilling device. In other embodiments, the inner insulating layer 322 extends to cover only the end portion (or tip portion) of the RF drilling device.

[0043] In some embodiments, the outer insulating layer 321 does not extend to the distal tip. In some embodiments, as shown in Figures 3A–3C, the distal tip 320 includes a distal surface defining a distal opening 305, thereby forming a distal port. In some embodiments, the forward-facing distal port opening 305 facilitates the use of a guide wire on the device. In some embodiments, the inner insulating layer 322 and the outer insulating layer 321 may be used to further facilitate the delivery of the guide wire on the device. In various embodiments, the electrically insulated inner layer 322 and outer layer 321 may be formed from a heat-shrinkable material, including, for example, one or more of polyolefins, fluoropolymers (such as FEP, PTFE, or Kynar), PVC, or neoprene. In some embodiments, the inner layer and / or outer layer are formed from fluorinated ethylene propylene (FEP). In some embodiments, the distal portion 366 is conductive and can transmit high-frequency energy supplied by an external RF generator (not shown) to the tip electrode 315, which can then be subsequently delivered to the target tissue in transseptal or epicardial ablation procedures.

[0044] In some embodiments, the slot 325 at the distal tip 320 forms the distal surface. In some embodiments, the distal surface forms a C-shaped electrode profile. To insulate the RF drilling device and the slot 325, the inner insulating layer 322 and the outer insulating layer 321 surround the RF drilling device, with only the tip electrode 315 of the device exposed, as shown in Figures 3A-3C. In some embodiments, the slot 325 may be insulated by placing reflowed fluorinated ethylene propylene (FEP) between the inner insulating layer 322 and the outer insulating layer 321. In some embodiments, the reflow of the FEP can fix both the inner insulating layer 322 and the outer insulating layer 321 of PTFE together. In other embodiments, the slot 325 may be insulated by mechanically laminating the layers. In yet another embodiment, the slot 325 may be insulated by folding the inner insulating layer 322 over the outer insulating layer 321, as shown in Figure 3A. In some embodiments, as shown in Figure 3C, the distal tip is beveled with a rounded edge to minimize unintended mechanical punctures, thereby increasing the surface area which provides better bumping when the RF puncture device is in contact with the target tissue.

[0045] In some embodiments, as shown in Figure 3A, the distal tip 320 is a dome-shaped tip, where the inner insulating layer 322 is wound under the outer insulating layer 321 to form a C-shaped electrode profile of the tip electrode 315. In some embodiments, as shown in Figure 3B, the distal tip 320 is a dome-shaped tip with a slot 325 that allows the inner insulating layer 322 and the outer insulating layer 321 to come into contact to form a C-shaped electrode profile of the tip electrode 315. Finally, in some embodiments, as shown in Figure 3C, the distal tip 320 is a bevel-shaped tip with a rounded edge that forms a bumper with a slot 325 that allows the inner insulating layer 322 and the outer insulating layer 321 to come together to form a C-shaped electrode profile of the tip electrode 315.

[0046] In some embodiments, to minimize the possibility of premature mechanical puncture, the edge of the tip electrode 315 may be blunted and introduced through the distal opening aperture 305. This increases the surface area at the distal tip and forms a bumper. To prevent coring, which occurs when a tissue core is formed inside the lumen due to the circumferential RF profile of the RF puncture device tip, a C-shaped electrode profile, as shown in Figures 3A-3C, may be designed. This creates a C-shaped incision in the tissue at the target site when gaining access to the epicardium or transseptal space. In some embodiments, to achieve this, a slot 325 is formed at the distal tip where both the inner insulating layer 322 and the outer insulating layer 321 can converge. Thus, in some embodiments, the slot 325 at the distal tip is created to generate a C-shaped electrode profile. In some embodiments, a larger C-shaped profile at the apex is more ideal in preventing coring. In some embodiments, the tip electrode 315 may have a shape other than a C-shaped electrode profile.

[0047] 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 specific features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of the invention is intended to encompass all such alternatives, modifications, and variations that fall within the scope of the claims, along with all their equivalents.

Claims

1. A high-frequency drilling device, An elongated member defining a lumen, the elongated member extending from a proximal portion including a hub to a distal tip electrode having a distal surface defining a distal opening and a distal portion including a slot, An outer insulating layer that covers a portion of the outer surface of the elongated member but does not cover the distal tip electrode, An inner insulating layer covering at least the distal portion of the lumen and A high-frequency drilling device equipped with the following features.

2. The distal surface forms a C-shaped electrode profile, according to claim 1, the high-frequency drilling device.

3. The high-frequency drilling device according to claim 1 or 2, wherein the C-shaped electrode is adapted to form a C-shaped incision in the tissue of a target site.

4. The high-frequency drilling device according to claim 1, wherein the inner insulating layer extends through the slot and is bonded to the outer insulating layer.

5. The high-frequency drilling device according to any one of claims 1 to 3, wherein the inner insulating layer extends below the outer insulating portion to form the C-shaped electrode profile.

6. The high-frequency drilling device according to claim 1, wherein fluorinated ethylene propylene (FEP) is disposed in the slot between the inner insulating layer and the outer insulating layer.

7. The high-frequency drilling device according to claim 1, wherein the inner insulating layer and the outer insulating layer extend within the slot and are joined within the slot.

8. The high-frequency drilling device according to claim 1, wherein the distal tip electrode has a dome-shaped tip.

9. The high-frequency drilling device according to claim 1, wherein the distal tip electrode has a bevel-shaped tip.

10. The high-frequency drilling device according to claim 1, wherein the outer insulator is formed from a heat-shrinkable material.

11. The high-frequency drilling device according to claim 1, wherein the inner insulator is formed from fluorinated ethylene propylene (FEP).

12. The high-frequency drilling device according to claim 1, wherein the distal opening is a port opening facing forward.

13. The high-frequency drilling device according to any one of claims 1 to 12, wherein the forward-facing port opening facilitates the use of a guide wire on the device.

14. The high-frequency drilling device according to any one of claims 1 to 13, wherein the C-shaped electrode profile is larger at the top of the electrode tip.

15. The radio frequency drilling device according to claim 1, wherein the distal portion is conductive and capable of transmitting radio frequency energy supplied by an external RF generator to the distal tip electrode, and then delivering it to target tissue.

16. A high-frequency drilling device, An elongated member defining a lumen, the elongated member extending from a proximal portion including a hub to a distal tip electrode having a distal surface defining a distal opening and a distal portion including a slot, An outer insulating layer that covers a portion of the outer surface of the elongated member but does not cover the distal tip electrode, An inner insulating layer covering at least the distal portion of the lumen and A high-frequency drilling device equipped with the following features.

17. The distal surface forms a C-shaped electrode profile, according to claim 16, the high-frequency drilling device.

18. The high-frequency drilling device according to claim 17, wherein the C-shaped electrode is adapted to form a C-shaped incision in the tissue of a target site.

19. The high-frequency drilling device according to claim 16, wherein the inner insulating layer extends through the slot and is bonded to the outer insulating layer.

20. The high-frequency drilling device according to claim 19, wherein the inner insulating layer extends below the outer insulating portion to form the C-shaped electrode profile.

21. The high-frequency drilling device according to claim 16, wherein fluorinated ethylene propylene (FEP) is disposed in the slot between the inner insulating layer and the outer insulating layer.

22. The high-frequency drilling device according to claim 16, wherein the inner insulating layer and the outer insulating layer extend within the slot and are joined within the slot.

23. The high-frequency drilling device according to claim 16, wherein the outer insulator is formed from a heat-shrinkable material.

24. The high-frequency drilling device according to claim 16, wherein the inner insulator is formed from fluorinated ethylene propylene (FEP).

25. The high-frequency drilling device according to claim 16, wherein the distal opening is a port opening facing forward.

26. An epicardial or transseptal transverse system, A dilator body that defines the dilator lumen and a dilator having a tapered distal tip, An elongated member defining a lumen, the elongated member extending from a proximal portion including a hub to a distal tip electrode having a distal surface defining a distal opening and a distal portion including a slot, An outer insulating layer that covers a portion of the outer surface of the elongated member but does not cover the distal tip electrode, An inner insulating layer covering at least the distal portion of the lumen and Equipped with, A transverse system in which the elongated member advances through the dilator lumen and is adapted to deliver RF energy to the distal tip electrode.

27. The transverse system according to claim 26, wherein the distal surface forms a C-shaped electrode profile.

28. The transverse system according to claim 27, wherein the C-shaped electrode is adapted to form a C-shaped incision in the tissue of the target site.

29. The transverse system according to claim 26, wherein the inner insulating layer extends through the slot and is bonded to the outer insulating layer.

30. The transverse system according to claim 29, wherein the inner insulating layer extends below the outer insulating portion to form the C-shaped electrode profile.

31. The transverse system according to claim 26, wherein fluorinated ethylene propylene (FEP) is disposed in the slot between the inner insulating layer and the outer insulating layer.

32. The transverse system according to claim 26, wherein the inner insulating layer and the outer insulating layer extend within the slot and are joined within the slot.

33. The transverse system according to claim 26, wherein the distal tip electrode has a dome-shaped tip.

34. The transverse system according to claim 26, wherein the distal tip electrode has a bevel-shaped tip.

35. A method involving the epicardium or transseptal crossing, To provide an elongated member that defines a lumen, extending from a proximal portion including a hub to a distal tip electrode having a distal surface that defines a distal opening and a distal portion including a slot, The elongated member is advanced into the patient's heart so that the distal end electrode contacts the septum of the heart. The method involves supplying RF energy to the distal electrode so that the distal electrode penetrates the septum and enters the left atrium of the heart. Methods that include...

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