Devices and methods for epicardial access

Abstract

Disclosed herein are systems and devices for accessing an epicardial space of a patient. The system can comprise an elongated body comprising a proximal end, a distal end, and a lumen therethrough. The system can further comprise a distal tip at the distal end of the elongated body, wherein the distal tip further comprises a distal window. The system can further comprise an endoscope positioned through the lumen, wherein an endoscope tip is positioned within the distal window, a vacuum source in fluid communication with the lumen, wherein the vacuum source is configured to draw tissue into the lumen through the distal window, a needle advanceable through the lumen, wherein the needle is configured to be advanced through the tissue, wherein the needle remains within the distal window when advanced through the tissue, and a guidewire advanceable through the needle, the guidewire being configured to advance through the tissue.

Description

TITLEDEVICES AND METHODS FOR EPICARDIAL ACCESSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 63 / 610,921 filed December 15, 2023, the entirety of which is incorporated by reference.FIELD OF TECHNOLOGY

[0002] The present disclosure relates generally to the field of epicardial access, and more specifically, accessing the pericardium safely and repeatably.BACKGROUND

[0003] There are several procedures currently being done in the epicardial space by electrophysiologists using a percutaneous approach. The state of the art for access involves using a needle and fluoroscopic guidance to access the pericardium and place a guidewire. This approach carries enough of a substantial level of risk of puncture of unintended tissue (right ventricle, liver, diaphragm) with the needle that it has proven to be a barrier to entry for some electrophysiologists.

[0004] Further, the sharpness of the needle can shave material off the guidewire during use, which can lead to particulate being left within the anatomy. Existing devices either do not provide for visualization or suction, or advance through the tissue with a needle.

[0005] Therefore, there remains a need for methods and devices for using visualization and vacuum to draw the pericardium into the device and visualize insertion of the needle into the pericardium while eliminating the possibility of inadvertent puncture and particulate remains after use.SUMMARY

[0006] Disclosed herein are systems and devices for accessing an epicardial space of a patient. The system can comprise an elongated body comprising a proximal end, a distal end, and a lumen therethrough. The system can further comprise a distal tip at the distal end of the elongated body, wherein the distal tip further comprises a distal window. The system can further comprise an endoscope positioned through the lumen, wherein anendoscope tip is positioned within the distal window, a vacuum source in fluid communication with the lumen, wherein the vacuum source is configured to draw tissue into the lumen through the distal window, a needle advanceable through the lumen, wherein the needle is configured to be advanced through the tissue, wherein the needle remains within the distal window when advanced through the tissue, and a guidewire advanceable through the needle, the guidewire being configured to advance through the tissue.

[0007] The system can further comprise a handle at the proximal end of the elongated body, wherein the handle comprises a vacuum tubing connected to the vacuum source, and wherein the handle comprises a guidewire port. The needle can be configured to flex when advanced through the lumen. The system can further comprise a needle locking mechanism, wherein the needle locking mechanism is spring loaded. The needle can be retractable into the elongated body independent from the guide wire.

[0008] The distal window can be clear. The distal window can comprise a radiopaque marker. The distal window can be made of a radiopaque material.

[0009] The distal tip can further comprise a fin configured to break through tissue. The system can further comprise a flushing port configured to remove debris from the distal window. The system can further comprise a shield to prevent tissue from entering the distal tip. The system can further comprise a liner attached to the handle, wherein the liner is configured to shield the guidewire from edges of the needle.

[0010] In some variations, the system for accessing an epicardial space of a patient can comprise an elongated body comprising a proximal end, a distal end, and a lumen therethrough; a distal tip at the distal end of the elongated body, wherein the distal tip further comprises a distal window; an endoscope positioned through the lumen, wherein an endoscope tip is positioned within the distal window; a vacuum source in fluid communication with the lumen, wherein the vacuum source is configured to draw tissue into the lumen through the distal window; a radiofrequency element advanceable through the lumen, wherein the radiofrequency element is configured to cut through the tissue; and a guidewire advanceable through the radiofrequency element, the guidewire being configured to advance through the tissue.

[0011] In some variations, a method for accessing an epicardial space of a patient can be provided. The method can comprise: advancing an elongated body to a target site,the elongated body comprising a proximal end, a distal end, and a lumen therethrough, wherein a distal tip is positioned at the distal end of the elongated body, the distal tip comprising a distal window; advancing an endoscope through the lumen, wherein an endoscope tip is positioned within the distal window; drawing a tissue at the target site into the distal window via a vacuum source in fluid communication with the lumen; puncturing the tissue with a needle advanceable through the lumen; advancing a guidewire through a lumen of the needle; and retracting the elongated body, the needle, and the endoscope such that the guidewire remains positioned through the tissue.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Fig. 1 illustrates a perspective view of an access device according to one variation of the invention.

[0013] Fig. 2 illustrates a method of accessing an epicardial space according to one variation of the invention.

[0014] Fig. 3 illustrates an access device with a spring loaded needle according to another variation of the invention.

[0015] Fig. 4 illustrates an access device with a radiofrequency enabled needle according to another variation of the invention.

[0016] Fig. 5 illustrates an access device with a roof vent according to another variation of the invention.

[0017] Figs. 6A and 6B illustrate a fixed liner within a needle according to one variation of the device.

[0018] Figs. 7 A to 7C illustrate a mechanism for a retracting liner within a needle according to one variation of the device.DETAIEED DESCRIPTION

[0019] Described here are systems, devices, and methods for accessing the epicardial space through the pericardium. While the devices and methods described here are described in reference to puncturing the pericardium to provide access to the heart of a patient, it should be understood that these devices and methods may be used to create apuncture in or otherwise facilitate access to any fluid-filled membrane or sac to access the structures therein, e.g., dura mater, peritoneum, amniotic sac, and the like.

[0020] Fig. 1 illustrates a perspective view of an access device 100 according to one variation of the invention. The device 100 can comprise a handle 101, an outer shaft or elongated body 102, and a distal tip 104 at a distal end of the outer shaft 102.

[0021] The handle 101 can comprise a needle actuator 106, a scope actuator 108, and a guide wire port 110 for introducing a guide wire 112 at a proximal end of the handle. The needle actuator 106 can be used to advance or retract a needle 212 through the lumen 206 of the outer shaft 102. In some embodiments, the needle actuator 106 can comprise a piston. The piston can be actuated by a user to control advancement of the needle 212 by proximally or distally moving the piston with respect to the outer shaft 102. Accordingly, the user can control the speed at which the needle 212 is advanced. The needle 212 can thereby be advanced into the distal tip 104 when the distal tip 104 is positioned at a desired location (i.e., at or near the outer pericardium).

[0022] In other embodiments, a wheel mechanism can be used to advance and retract the needle 212.

[0023] The needle actuator 106 can also be used to control the rotation of the needle 212 within the outer shaft 102. To rotate the needle 212, the user can rotate the piston radially with respect to the outer shaft 102. The piston can comprise grooves or ribs 114 extending axially for the user to grip during rotation of the needle 212.

[0024] The needle 212 can flex upward (i.e., away from the pericardium and the epicardium) during advancement of the needle 212. The needle 212 can thus grab tissue it can ride up a bleb of the tissue as the needle is advanced to reduce the risk of puncturing the ventricle or surrounding tissue.

[0025] The needle actuator 106 can comprise a tab that locks within the handle 101 to ensure orientation of the needle 212 when delivered. This feature provides for safety from the risk of puncturing nearby tissue during advancement of the needle 212 as the needle 212 can maintain the appropriate angle when approaching the tissue. The needle 212 can also have an atraumatic tip or edge that allows the needle 212 to contact tissue without damaging the tissue.

[0026] The needle 212 can be a 17 to 25 gauge needle with an atraumatic shape to minimize the risk of dangerous puncture in the event of ventricular stick.

[0027] The needle 212 can include a central lumen that extends therethrough, enabling advancement of the guidewire 112 through the device / needle and into the pericardium. The guidewire 112 can be advanced through the needle 212 accordingly when the needle 212 is inserted through a port on the needle actuator 106.

[0028] The handle 101 can be coupled to a vacuum port 116 for applying suction through the outer shaft 102. The vacuum port 116 can be connected to a vacuum tubing 118 and a vacuum source (not shown) in fluid communication with the outer shaft 102. A valve 120 can be positioned on the vacuum port 116 to couple the vacuum source with the handle 101. The vacuum source can apply suction to the lumen of the outer shaft 102, which draws the outer pericardium into the distal tip 104 for engagement with the needle 212.

[0029] The handle 101 can be coupled to a camera unit 122 which can be coupled to or otherwise embedded within the endoscope 210. The endoscope 210 can be introduced through an endoscope port on the handle 101. The endoscope 210 can comprise a diameter of about 3mm and can be rigid so as to not interfere with the needle 212 during the procedure but flexible to maneuver as needed through the outer shaft 102. The scope actuator 108 on the handle can rotate and / or axially advance the endoscope 210.

[0030] In some embodiments, the handle 101 can be coupled to a flushing port to aid in removing loose tissue and / or debris from the distal tip 104.

[0031] Fig. 2 illustrates a diagram of a method of accessing an epicardial space according to one variation of the invention. The distal tip 104 can be advanced to a location adjacent to a space between the outer pericardium 200 and the epicardium 202 to be accessed. Once the distal tip 104 is in the desired position, the vacuum source can apply a vacuum through the outer shaft to retract the pericardium and the epicardium into a cavity 204 of the distal tip 104.

[0032] The outer shaft 102 can house a needle and an endoscope within a lumen 206 of the outer shaft 102. In some embodiments, the outer shaft 102 can comprise a multi-lumen configuration in which the needle and the endoscope can advance within separate lumens. In some embodiments, the outer shaft 102 can comprise an inner shaft disposed within, in which the needle 212 or endoscope 210 can be disposed through while the other of the needle or endoscope is disposed in a space outside of the inner shaft and inside of the outer shaft.

[0033] The distal tip 104 of the device 100 can be clear for visualization of the surrounding anatomy during blunt dissection via the endoscope. The distal tip 104 can be radiopaque for the purposes of gross navigation and trajectory control during blunt dissection. The distal tip 104 can comprise a fin on its leading edge to aid in breaking through connective tissue during blunt dissection.

[0034] The distal tip 104 can have a clear distal window for visualization. The distal tip 104 can protect a standard endoscope from surrounding tissues enabling dissection and navigation to the pericardium through a sub-xiphoid skin incision under endoscopic visualization. The optically clear window can also include a radiopaque marker or be made from radiopaque material for the user to be able to confirm the distal-most region of the device under fluoroscopy. In some embodiments, the window 208 can have a shield to prevent unwanted tissue from entering the cavity 204 of the distal tip and obstructing the endoscopic view.

[0035] The device 100 can enable direct endoscopic visualization of the pericardium before, during, and after entry into the pericardium. The device 100 can be used with commercially available scopes and cameras. The device 100 can also position the endoscope 210 and / or camera with a scope retention mechanism.

[0036] Step 201 illustrates the distal tip 104 first delivered to the target location. The endoscope 210 can provide visualization of the target location and the distal tip 104 can be pressed against the heart (i.e., at the outer pericardium and epicardium). Step 203 illustrates when the vacuum source has applied vacuum through the outer shaft 102, resulting in the outer pericardium 200 and the epicardium 202 being retracted into the cavity 204 of the distal tip 104 through the window 208.

[0037] Step 205 illustrates the needle 212 advanced into cavity 204 to puncture the outer pericardium 200 and ultimately placed adjacent to the epicardium 202. The endoscope 210 provides visualization of the tissue throughout this process. After the needle has been successfully inserted into the outer pericardium, the guide wire can be advanced through the needle, as seen in step 207. The needle 212 is then removed while the guidewire 112 remains in place as seen in step 209. The device 100 can be removed shortly thereafter if necessary. Since the pericardium 200 is drawn into the device, the needle 212 does not exit the envelope dimensions of the distal window, eliminating the possibility of inadvertent puncture of non-target tissues.

[0038] In some embodiments, the clear, blunt dissection window of the distal tip 104 can be a variety of shapes and sizes as well as a variety of textures.

[0039] In other embodiments, an integrated chip on the tip system can be used to eliminate the need to insert an endoscope into the device. A video sensor (e.g., CMOS) can be integrated into the distal tip 104 of the device, improving the ergonomics of the system by eliminating the size and weight of the endoscope 210 and camera attached at the proximal end of the embodiment of Fig. 1. This variation can also enable use of a flexible or steerable shaft, and also may reduce the overall crossing profile of the device.

[0040] Fig. 3 illustrates an embodiment of an access device with a spring loaded needle according to another variation of the invention. The spring loaded needle can be activated by an activation button 302 on the handle 101. The needle 212 can be retracted by a retraction button 300 to reset the needle 212 in a spring-loaded state. This variation can eliminate user influence over advancement of the needle 212 as the activation button 302 and the retraction button 304 can have predetermined limits on how far the needle 212 can move through the outer shaft 102. In some variations, the needle 212 can be a beveled needle, a hypodermic needle, or the like.

[0041] Fig. 4 illustrates an access device with a radiofrequency (RF) enabled needle 400 according to another variation of the invention. First, as seen in step 401, the distal tip 104 is delivered to the target site, where it is pressed against the pericardium 200, which enters the window 208. Vacuum is then applied to retract the pericardium further into the window 208, as seen in step 403.

[0042] Radiofrequency leads (not shown) can be connected or attached to the needle 400. RF energy can be generated through the radiofrequency leads to gently cut through the pericardium 200 or coagulate as necessary after the pericardium is retracted into the cavity 204, as seen in step 405. The pericardial puncture is not based on axial force, so there is less energy buildup of the tissue and subsequent tissue recoil once the needle 400 punctures through the pericardium 200. Accordingly, there is a low advancement force of the needle 400 during the procedure. Since RF energy does not require significant pressure to gain pericardial puncture, the risk of the energy build up and recoil is reduced.

[0043] In some variations, the needle 400 can be a sharp needle, a dull needle, or a blunt hypo tube.

[0044] In some variations, RF leads can be attached to the guidewire 112 which can cut through pericardium.

[0045] In some variations of the device, a smaller needle (about 29 to about 32 Ga) can be introduced through a larger needle (about 22 Ga) to minimize risk during the pericardial puncture. The smaller needle can initially puncture the pericardium. The initial puncture of the smaller needle can inherently reduce the risk of bleeding. Once the initial puncture is made, the vacuum between the pericardium and heart can be broken, allowing air to enter the epicardial space and improving the ability of the vacuum applied to the pericardium to separate the pericardium from the ventricular surface. More separation between the pericardium and ventricular surface greatly reduces the risk of ventricular damage when the second, larger needle is inserted. After the larger needle is inserted, the smaller needle is withdrawn out of the device so that the guidewire can be delivered through the larger needle.

[0046] One technical problem encountered by the inventors is separating the pericardium from the ventricle, such that when the needle is advanced through the pericardium, the needle does not stick the ventricle. Technical solutions discovered by the applicants provide for methods of gaining separation between the pericardium and the ventricle prior to advancing the needle through the pericardium that the wire will be fed through.

[0047] Fig. 5 illustrates one variation of a distal tip with a roof vent for venting or breaking the vacuum state between the pericardium and ventricle to allow the vacuum applied by the device to separate the pericardium from the ventricle or ventricular surface. In this variation, a needle 500 (about 30 Ga) is affixed to the roof of the cavity in the distal tip 104 and communicates outside of the distal tip 104.

[0048] As the tissue is retracted into the distal tip 104 via suction, the pericardial tissue raises up into the distal tip 104. The needle 500 in the distal tip roof communicates to the outside of the device and can comprise a lumen such that the vacuum pump can overcome a leak path and still generate enough vacuum to retract the pericardium. When the pericardium retracts into the device, it contacts the needle at the roof of the suction aperture such that the needle punctures the pericardium. The epicardial space is accordingly vented and the pericardium can separate from the ventricle.

[0049] One technical problem encountered by the inventors is that advancing, and particularly retracting, a coated guide wire through a needle can result in the sharp internal edges of the distal end of the needle lumen to scrape off the guide wire coating and produce particulate. Technical solutions designed by the applicant comprise design solutions to the needle, which require less prior training for the user when retracting the guidewire.

[0050] For example, Figs. 6 A and 6B illustrate a liner 600 within a needle 212 according to one variation of the device. This variation can comprise a thin-walled polymer liner 600 installed inside a needle lumen to protect the guidewire 112 from the inner edges of the needle. The liner can be bonded in place and then laser-trimmed at the distal end to match the grind angle of the needle. The liner may be trimmed flush to the needle 212. In other embodiments, the liner can be trimmed with an intentional overhang from the needle 212 to provide additional protection.

[0051] In some embodiments, the liner 600 can be removably coupled to the needle 212.

[0052] In some embodiments, a metal hypotube can be used to puncture the pericardial tissue but is not advanced into the epicardial space. Instead, after RF cutting of the tissue, a polymer liner is advanced through the puncture site and into the epicardial space. This embodiment carries less risk of the inadvertently cutting or burning the ventricular tissue with the RF element which is not advanced into the epicardial space. Advancement of the polymer liner can create a lumen into the epicardial space to advance the guidewire 112.

[0053] Figs. 7 A to 7C illustrate a mechanism for a retracting liner within a needle according to one variation of the device. In this variation, an extending or retracting liner is attached to a liner actuator 700 at the device handle that allows the user to extend and retract the liner. The liner can be retracted during pericardial puncture so that the liner does not impact needle puncture performance.

[0054] A safety clip 702 can be employed along the liner actuator 700 to ensure that the user always extends the liner prior to advancing or retracting the guide wire. The safety clip 702 can clamp onto the liner actuator 700 such that the liner actuator 700 cannot move axially while the needle 212 is positioned within the distal tip 104, as seen in Fig. 7B.Once the safety clip 702 is removed, the liner can then be extended once the needle is in the epicardial space to provide ample protection for the guide wire, as seen in Fig. 7C.

[0055] In some embodiments, a laser process can be used to melt an inner sharp edge of the distal tip of the needle 212 to produce a smooth radius to prevent damage to the guidewire 112 from moving past the edge of the needle 212.

[0056] In some embodiments, the needle can have an adhesive applied to an inner edge thereof. In this variation, an adhesive can be applied to the inner edge of the needle to create a radius and reduce the risk of guide wire damage. In some embodiments, the adhesive can be ultraviolet-cured.

[0057] In some embodiments, the needle can be made with a deep cut during fabrication. The cut could be made by EDM, laser, waterjet, or milling to reduce the sharp edge formed by the needle manufacturing process.

[0058] In other embodiments, an abrasive slurry process could be used which involves flowing an abrasive slurry through the needle to soften the internal edge.

[0059] In other embodiments, a diamond wire grinding process can be used for fabrication of the needle. The process uses a diamond wire file to grind the opening of the needle to a smooth configuration. Accordingly, this reduces the risk of the needle shaving off particulate from the guidewire when the guidewire is passed through.

[0060] The diamond grinding process can comprise a machine for spinning the diamond wire in order to grind the inside of the needle. The diamond wire can be rotated while the needle is held by a platform that oscillates the needle back and forth. A heel attack angle, a toe attack angle, and a nominal angle all can be used for which the needle is ground to during the procedure.

[0061] A fixture setup for the grinding process can comprise a computer unit with a configurator connected to a control box. The control box can be coupled to the fixture mechanism via a wire. The control box can also be coupled to a wire connector for uploading a grinding program as desired by the user.

[0062] After grinding, the interior of the needle can have a smooth surface such that a guidewire can pass through with less risk of particulate being shaved off into the anatomy.

[0063] A number of embodiments have been described. Nevertheless, it will be understood by one of ordinary skill in the art that various changes and modifications can be made to this disclosure without departing from the spirit and scope of the embodiments. Elements of systems, devices, apparatus, and methods shown with any embodiment areexemplary for the specific embodiment and can be used in combination or otherwise on other embodiments within this disclosure. For example, the steps of any methods depicted in the figures or described in this disclosure do not require the particular order or sequential order shown or described to achieve the desired results. In addition, other steps or operations may be provided, or steps or operations may be eliminated or omitted from the described methods or processes to achieve the desired results. Moreover, any components or parts of any apparatus or systems described in this disclosure or depicted in the figures may be removed, eliminated, or omitted to achieve the desired results. In addition, certain components or parts of the systems, devices, or apparatus shown or described herein have been omitted for the sake of succinctness and clarity.

[0064] Accordingly, other embodiments are within the scope of the following claims and the specification and / or drawings may be regarded in an illustrative rather than a restrictive sense.

[0065] Each of the individual variations or embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other variations or embodiments. Modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit, or scope of the present invention.

[0066] Methods recited herein may be carried out in any order of the recited events that is logically possible, as well as the recited order of events. Moreover, additional steps or operations may be provided or steps or operations may be eliminated to achieve the desired result.

[0067] Furthermore, where a range of values is provided, every intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. For example, a description of a range from 1 to 5 should be considered to have disclosed subranges such as from 1 to 3, from 1 to 4, from 2 to 4, from 2 to 5, from 3 to 5, etc. as well as individual numbers within that range, for example 1.5, 2.5, etc. and any whole or partial increments therebetween.

[0068] All existing subject matter mentioned herein (e.g., publications, patents, patent applications) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.

[0069] Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0070] Reference to the phrase “at least one of’, when such phrase modifies a plurality of items or components (or an enumerated list of items or components) means any combination of one or more of those items or components. For example, the phrase “at least one of A, B, and C” means: (i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; or (vii) A and C.

[0071] In understanding the scope of the present disclosure, the term “comprising” and its derivatives, as used herein, are intended to be open-ended terms that specify the presence of the stated features, elements, components, groups, integers, and / or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and / or steps. The foregoing also applies to words having similar meanings such as the terms, “including”, “having” and their derivatives. Also, the terms “part,” “section,” “portion,” “member” “element,” or “component” when used in the singular can have the dual meaning of a single part or a plurality of parts. As used herein, the following directional terms “forward, rearward, above, downward, vertical, horizontal, below, transverse, laterally, and vertically” as well as any other similar directional terms refer to those positions of a device or piece of equipment or those directions of the device or piece of equipment being translated or moved.

[0072] Finally, terms of degree such as “substantially”, “about” and “approximately” as used herein mean the specified value or the specified value and a reasonable amount of deviation from the specified value (e.g., a deviation of up to ±0.1%, ±1%, ±5%, or ±10%, as such variations are appropriate) such that the end result is not significantly or materially changed. For example, “about 1.0 cm” can be interpreted to mean “1.0 cm” or between “0.9 cm and 1.1 cm.” When terms of degree such as “about” or “approximately” are used to refer to numbers or values that are part of a range, the term can be used to modify both the minimum and maximum numbers or values.

[0073] It will be understood by one of ordinary skill in the art that the various methods disclosed herein may be embodied in a non-transitory readable medium, machine-readable medium, and / or a machine accessible medium comprising instructions compatible, readable, and / or executable by a processor or server processor of a machine, device, or computing device. The structures and modules in the figures may be shown as distinct and communicating with only a few specific structures and not others. The structures may be merged with each other, may perform overlapping functions, and may communicate with other structures not shown to be connected in the figures. Accordingly, the specification and / or drawings may be regarded in an illustrative rather than a restrictive sense.

[0074] This disclosure is not intended to be limited to the scope of the particular forms set forth, but is intended to cover alternatives, modifications, and equivalents of the variations or embodiments described herein. Further, the scope of the disclosure fully encompasses other variations or embodiments that may become obvious to those skilled in the art in view of this disclosure.

Claims

CLAIMSWe claim:

1. A device for accessing an epicardial space of a patient, the device comprising: an elongated body comprising a proximal end, a distal end, and a lumen therethrough; a distal tip at the distal end of the elongated body, wherein the distal tip further comprises a distal window; an endoscope positioned through the lumen, wherein an endoscope tip is positioned within the distal window; a vacuum source in fluid communication with the lumen, wherein the vacuum source is configured to draw tissue into the lumen through the distal window; a needle advanceable through the lumen, wherein the needle is configured to be advanced through the tissue, wherein the needle remains within the distal window when advanced through the tissue; and a guidewire advanceable through the needle, the guidewire being configured to advance through the tissue.

2. The device of claim 1, further comprising a handle at the proximal end of the elongated body, wherein the handle comprises a vacuum tubing connected to the vacuum source, and wherein the handle comprises a guidewire port.

3. The device of claim 1, wherein the needle is configured to flex when advanced through the lumen.

4. The device of claim 1, further comprising a needle locking mechanism, wherein the needle locking mechanism is spring loaded.

5. The device of claim 1, wherein the needle is retractable into the elongated body independent from the guide wire.

6. The device of claim 1, wherein the distal window is clear.

7. The device of claim 6, wherein the distal window comprises a radiopaque marker.

8. The device of claim 1, wherein the distal window is made of a radiopaque material.

9. The device of claim 1, wherein the distal tip further comprises a fin configured to break through tissue.

10. The device of claim 1, further comprising a flushing port configured to remove debris from the distal window.

11. The device of claim 1, further comprising a shield to prevent tissue from entering the distal tip.

12. The device of claim 1, further comprising a liner attached to the handle, wherein the liner is configured to shield the guidewire from edges of the needle.

13. A device for accessing an epicardial space of a patient, the device comprising: an elongated body comprising a proximal end, a distal end, and a lumen therethrough; a distal tip at the distal end of the elongated body, wherein the distal tip further comprises a distal window; an endoscope positioned through the lumen, wherein an endoscope tip is positioned within the distal window; a vacuum source in fluid communication with the lumen, wherein the vacuum source is configured to draw tissue into the lumen through the distal window; a radiofrequency element advanceable through the lumen, wherein the radiofrequency element is configured to cut through the tissue; and a guidewire advanceable through the radiofrequency element, the guidewire being configured to advance through the tissue.

14. A method for accessing an epicardial space of a patient, the method comprising: advancing an elongated body to a target site, the elongated body comprising a proximal end, a distal end, and a lumen therethrough, wherein a distal tip is positioned at the distal end of the elongated body, the distal tip comprising a distal window; advancing an endoscope through the lumen, wherein an endoscope tip is positioned within the distal window;drawing a tissue at the target site into the distal window via a vacuum source in fluid communication with the lumen; puncturing the tissue with a needle advanceable through the lumen; advancing a guidewire through a lumen of the needle; and retracting the elongated body, the needle, and the endoscope such that the guidewire remains positioned through the tissue.

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