Pericardial access

Abstract

To meet the need to access internal anatomic structures that may be covered by a layer of tissue.SOLUTION: Medical devices and medical measuring instruments, particularly pericardial access systems and pericardial access devices and related methods are disclosed. Some example pericardial access devices may include a distally located, expandable skirt configured to engage the pericardium. When extended, the skirt may be wider than the tubular body of the device. Some example pericardial access devices may include an at least partially transparent, repositionable tip.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 695,422, filed Jun. 9, 2018, which is incorporated herein by reference.

[0002] The present disclosure is directed to medical devices and medical devices and related methods, and more particularly to surgical devices and related methods for accessing the pericardial cavity.

Summary of the Invention

Means for Solving the Problems

[0003] A first aspect of the present disclosure provides a surgical device for accessing a patient's pericardial cavity, the device being an elongate generally tubular body including a proximal end and a distal end, the tubular body including at least one longitudinal channel extending from the proximal end to the distal end, the at least one longitudinal channel being selectively receptive of an obturator and a needle guide system, a handle disposed at the proximal end of the tubular body, and / or a selectively deployable suction skirt movable between a radially - reduced collapsed configuration and a radially - expanded expanded configuration including a distal edge defining a distal opening. In the expanded configuration, the distal edge of the skirt may be configured to sealingly engage the surface of a tissue layer, the distal opening of the skirt may be wider in the diametrical direction than the distal end of the tubular body, and / or the skirt may be configured to receive a portion of the tissue layer proximally when a suction force is applied by the tubular body.

[0004] In a more detailed embodiment of the first aspect, the skirt may be at least partially present inside the tubular body in the contracted configuration and may extend distally beyond the distal end of the tubular body in the expanded configuration. In the expanded configuration, the skirt may be generally frustoconical. The skirt may include at least one positioner operably coupled to an actuator disposed on the handle, and the at least one positioner may be configured to move the skirt between the contracted and expanded configurations. The at least one positioner may move the skirt distally and / or expand the skirt radially when moving the skirt from the contracted configuration to the expanded configuration. In the expanded configuration, the width of the distal opening of the skirt may be at least about 1.5 times the width of the distal end of the tubular body. The obturator may include a blunt-tipped dissecting point that is at least partially transparent and oriented distally and / or an endoscope positioned to observe through this point. The skirt may be constructed from nitinol wire braided into a mesh and / or may be at least partially covered with silicone. At least some of the wires of the mesh may be oriented at about 45 degrees with respect to the longitudinal axis of the tubular body such that pulling the distal edge of the skirt proximally causes the skirt to expand radially.

[0005] A second aspect of the present disclosure provides a method of accessing the pericardium, the method comprising advancing a distal end of a pericardial access device toward the pericardium, the advancing step comprising the obturator's blunt dissecting point extending distally from the distal end of the pericardial access device; retracting the obturator's dissecting point at least partially into the pericardial access device; repositioning a selectively deployable skirt proximal to the distal end of the pericardial access device from a radially contracted configuration to a radially expanded configuration, the repositioning step comprising, in the radially expanded configuration, the skirt extending distally beyond the pericardial access device and including a distal edge defining a distal opening; sealingly engaging the distal edge of the skirt with the pericardium; applying a suction force to the skirt to draw a portion of the pericardium proximally into the skirt, displacing the pericardium from the epicardium to create a previously non-existent range of motion; inserting a needle guide system into the pericardial access device such that a working end of the needle guide system extends into the skirt; extending a hollow needle of the needle guide system to pierce the pericardium; extending a guide wire through the hollow needle into the pericardial cavity; releasing the suction force on the skirt; repositioning the skirt from the radially expanded configuration to the radially contracted configuration; and / or withdrawing the pericardial access device from the pericardium while leaving the guide wire extended into the pericardial cavity.

[0006] In a more detailed embodiment of the second aspect, the step of repositioning the selectively deployable skirt from a radially contracted configuration to a radially expanded configuration may include extending the skirt distally and / or the step of repositioning the skirt from a radially expanded configuration to a radially contracted configuration may include contracting the skirt proximally. The advancing step may include visualizing the pericardium using an endoscope positioned to observe through at least a partially transparent incision point. The step of repositioning the selectively deployable skirt may include operating an actuator on the handle of the pericardial access device. The distal opening of the skirt may be wider than the distal end of the tubular body of the pericardial access device. The method may include retracting the hollow needle before releasing the suction force in the skirt.

[0007] A third aspect of the present disclosure provides a surgical device for accessing a patient's pericardial cavity, the device being an elongate tubular body including a proximal end and a distal end, the tubular body including a longitudinal first channel configured to receive an endoscope and a longitudinal second channel configured to receive a pericardial needle, and / or at least a partially transparent and repositionable tip disposed at the distal end of the tubular body, the tip including a distally oriented substantially round incision point and a proximal repositionable connector, the proximal repositionable connector being repositionably engaged with the tubular body near the distal end of the tubular body such that the tip can be repositioned between a closed configuration and an open configuration. In the closed configuration, the tip may substantially cover the distal end of the tubular body and / or extend distally beyond the distal end of the tubular body. In the open configuration, the tip may be disposed at least partially beside the distal end of the tubular body such that the distal surface of the tubular body is exposed.

[0008] In a more detailed embodiment of the third aspect, the proximal relocatable connector may include a pivot connector and / or the tip may be rotatable between a closed configuration and an open configuration about a tip pivot axis that is generally perpendicular to the longitudinal axis of the tubular body. The distal end of the tubular body may include a distal end surface that is inclined with respect to the longitudinal axis. The distal end of the tubular body may include a distal end surface that is generally perpendicular to the longitudinal axis of the tubular body. The first longitudinal channel may include a stop disposed to limit distal movement of the endoscope. The pericardial needle may not extend beyond the distal surface of the tubular body. The pericardial needle may be rotatable. The device may include a third longitudinal channel fluidly coupled to a suction port near the proximal end of the tubular body.

[0009] A fourth aspect of the present disclosure provides a method of accessing the pericardium, the method comprising guiding a pericardial access device including a tubular body and a tip including a rounded incision point that is relocatable between a closed configuration and an open configuration, toward the pericardium; visualizing the pericardium using an endoscope disposed to observe through the at least partially transparent incision point; repositioning the tip from the closed configuration to the open configuration in which the distal surface of the tubular body is exposed; sealingly engaging the distal surface of the tubular body with the pericardium; displacing the pericardium from the epicardium to form a previously non-existent range of motion by applying a suction force to a suction cavity at least partially defined by the distal surface, thereby drawing a portion of the pericardium into the suction cavity; puncturing the pericardium by extending a pericardial needle into the suction cavity; extending a guide wire through the pericardial needle into the pericardial cavity; releasing the suction force in the suction cavity; and / or withdrawing the pericardial access device from the pericardium while leaving the guide wire extended into the pericardial cavity.

[0010] In a more detailed embodiment of the fourth aspect, the step of repositioning the tip from the closed configuration to the open configuration may include the step of rotating the tip about the tip pivot axis. During the visualization step, the endoscope may be disposed inside a first channel extending through the tubular body, and / or during the puncturing step, the pericardial needle may be disposed inside a second channel extending through the tubular body. The method may include the step of retracting the pericardial needle before releasing the suction force in the suction cavity. The repositioning step may include the step of pressing the tip laterally against the anatomical structure to reposition the tip to the open configuration. In the closed configuration, the tip may substantially cover the distal end of the tubular body. The puncturing step may include the step of rotating the pericardial needle.

[0011] The fourth aspect of the present disclosure provides any device, method, or combination, such as embodiments in two or more and / or any combination of the above aspects disclosed herein, and / or any combination of any elements of any of the above.

[0012] Exemplary embodiments are described with reference to the accompanying drawings.

Brief Description of the Drawings

[0013]

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DETAILED DESCRIPTION OF THE INVENTION

[0014] Exemplary embodiments according to the present disclosure are described and illustrated below as encompassing devices, methods, and techniques related to medical procedures. Of course, the embodiments discussed below are examples, and it will be apparent to those skilled in the art that they can be reconfigured without departing from the scope and spirit of the present disclosure. It should also be understood that variations contemplated by those skilled in the art of the exemplary embodiments simultaneously include a part of this disclosure. However, for clarity and accuracy, the exemplary embodiments as discussed below may include optional steps, methods, and mechanisms that one should recognize are not necessary conditions for those skilled in the art to fall within the scope of the present disclosure.

[0015] The present disclosure includes, among other things, medical devices and medical measuring instruments and related methods, and more specifically, surgical instruments and related methods that can be used for pericardial access. The present disclosure contemplates that in some surgical procedures, such as minimally invasive procedures (e.g., endoscopic procedures), there may be a need to access internal anatomical structures that may be covered by layers of tissue. For example, in some minimally invasive cardiac surgeries, it may be necessary to penetrate the pericardium in order for a surgical instrument to be able to directly access the epicardium. Exemplary minimally invasive cardiac procedures that require access to the epicardium may include cardiac ablation for treating atrial fibrillation and occlusion of the left atrial appendage.

[0016] It is contemplated that it would be desirable to improve the safety and / or ease of use of some existing surgical instruments and methods related to pericardial access. For example, providing devices and methods that enable a surgeon to reach a desired pericardial access point and adapt to the patient's anatomical differences, limiting damage to adjacent anatomical structures (e.g., during insertion, manipulation, and / or resection), and / or enabling visualization of various aspects (e.g., device placement, pericardial surface, and / or adjacent structures) would be desirable.

[0017] FIG. 1 is a side view of an exemplary pericardial access system 10 according to at least some aspects of the present disclosure. The pericardial access device 100 that the system 10 may include may be configured to be used in relation to an obturator / endoscope 200 and / or a needle guide system 300.

[0018] In some exemplary embodiments, device 100 may include an elongated generally tubular body 102 having a longitudinal axis 104, a proximal end 106, and / or a distal end 108. The tubular body 102 may include at least one longitudinal channel 110 (FIG. 8) extending from the proximal end 106 to the distal end 108. The following description refers to channel 110, although some exemplary embodiments may include multiple similar longitudinal channels. A handle 112 may be disposed at the proximal end 106 of the tubular body 102. A suction port 114 may be fluidly coupled to the channel 110 for evacuating through at least one longitudinal channel 110 when a suction source is coupled to the suction port 114.

[0019] In some exemplary embodiments, channel 110 may be configured to receive an obturator / endoscope 200. The working end 202 of the obturator / endoscope 200 may extend distally from the distal end 108 of the device 100 when inserted into the channel 110. For example, the obturator / endoscope 200 may include a rounded cutting point 204 that is at least partially transparent and distally oriented and disposed at the distal end of the shaft 206. When the obturator / endoscope 200 is inserted into the tubular body 102 of the device 100, the cutting point 204 may extend at least partially distally from the distal end 108 of the tubular body 102 (see also FIG. 5). A coupling 208 that the obturator / endoscope 200 may include may be configured to releasably engage a corresponding coupling 116 on the proximal portion of the handle 112. The obturator / endoscope 200 may include an endoscope 210 disposed to observe through the point 204.

[0020] In some exemplary embodiments, channel 110 may be configured to receive needle guide system 300. When the working end 302 of needle guide system 300 is inserted into channel 110, it may extend distally from the distal end 108 of the tubular body 102 of device 100 (see FIGS. 8 and 9). Needle guide system 300 may be configured to insert guide wire 304 through channel 110 and through shaft 306 into the pericardial cavity when device 100 receives needle guide system 300. Coupling 308, which needle guide system 300 may include, may be configured to releasably engage a corresponding coupling 116 on the proximal portion of handle 112.

[0021] In some exemplary embodiments, handle 112 may include an actuator 118, such as a rotary knob, configured to reposition the movable mechanism of device 100. FIGS. 2-4 are perspective views of the distal end 108 of device 100 and show an example of a selectively deployable skirt 120 that can move between a collapsed configuration (FIG. 2), an intermediate configuration (FIG. 3), and / or an expanded configuration (FIG. 4), according to at least some aspects of the present disclosure. In some exemplary embodiments, in the collapsed configuration, skirt 120 may be at least partially within the tubular body 102.

[0022] In some exemplary embodiments, the skirt 120 may extend distally beyond the distal end 108 of the tubular body 102 in an extended configuration. In the extended configuration, the skirt 120 may have a generally frustoconical shape and / or may have a distal edge 122 that defines a distal opening 124 having a width 126. In the extended configuration, the width 126 of the distal opening 124 may be greater than the width 128 of the tubular body 102. For example, the width 126 of the distal opening 124 of the skirt 120 may be at least about 1.5 times, at least about 2.0 times, at least about 2.5 times, at least about 3.0 times, and / or at least about 3.5 times the width 128 of the tubular body 102. In some exemplary embodiments, such as the exemplary embodiment shown in FIG. 4, the distal opening 124 of the skirt 120 may be about 2.5 times to 3.0 times the width 128 of the tubular body 102.

[0023] In some exemplary embodiments, the skirt 120 can be moved between a collapsed configuration (FIG. 2) and an extended configuration (FIG. 4) by at least one positioner 130, 132, 134, 136 that is operably coupled to the actuator 118 of the handle 112. In the collapsed configuration, the skirt 120 can be radially reduced. In the extended configuration, the skirt 120 can be radially expanded. For clarity, the following description of the expansion and contraction of the skirt 120 focuses on the positioner 130, but it should be understood that the other positioners 132, 134, 136 (if present) can operate in a similar manner.

[0024] Referring to FIG. 2 showing the skirt 120 in a contracted configuration, the skirt 120 can be disposed entirely or substantially inside the tubular body 102. For example, the skirt 120 may be disposed inside the inner tube 138, which may be disposed entirely or substantially inside the tubular body 102 and / or may extend distally from the tubular body 102. The positioner 130 may extend from the outside of the inner tube 138, may fold around the distal end 140 of the inner tube 138, and / or may extend proximally of the skirt 120 inside the inner tube 138. In some exemplary embodiments, the positioner may be coupled to the skirt 120 at or near the distal edge 122 (FIGS. 3 and 4).

[0025] Referring to FIG. 3 showing an intermediate configuration, when the positioner 130 is repositioned proximally (e.g., by the action of the actuator 118), the positioner 130 expands radially and / or extends distally from the inner tube 138. This movement of the positioner 130 can cause the skirt 120 to be pulled distally outward from the inner tube 138.

[0026] Referring to FIG. 4 showing the expanded configuration, when the positioner 130 is further retracted (e.g., by the action of the actuator 118), the distal opening 124 is further expanded so that the width 126 of the distal opening 124 is greater than the width 128 of the tubular body 102. In some exemplary embodiments, when the positioner 130 is retracted proximally (e.g., by the action of the actuator 118), the positioner 130 pulls the distal edge 122 of the skirt 120 proximally, and the skirt 120 becomes shorter axially. The skirt 120 can be constructed to expand radially when shortened axially in a manner generally similar to a device known as a "Chinese finger trap" (e.g., a two-axis assembly wound helically around a cylinder that narrows radially when pulled axially and expands radially when compressed axially). Therefore, in the expanded configuration, the width 126 of the distal opening 124 can be greater than the width 128 of the tubular body 102. In some exemplary embodiments, one or more of the positioners 130, 132, 134, 136 can be selectively controllable (e.g., expandable and / or telescopic) such that the distal edge 122 of the skirt 120 can be inclined, angled, and / or biased with respect to the longitudinal axis 104, thereby facilitating a sealed engagement of the distal edge 122 of the skirt 120 with the pericardium 400 as described below (FIG. 7). For example, one or more of the positioners 130, 132, 134, 136 can be further retracted without further retraction and / or extension of the other positioners 130, 132, 134, 136, and thus the distal edge 122 is generally inclined towards the retracted positioners 130, 132, 134, 136. FIG. 24C is a detailed cross-sectional perspective view of the distal end 108' of an exemplary pericardial access device 100' (which may be generally similar to the pericardial access device 100) according to at least some aspects of the present disclosure, showing an inclined skirt 120'. In FIG. 24C, the positioner 130' has been further retracted and / or the positioner 134' has been further extended, thereby inclining the distal edge 122' of the skirt 120' towards the positioner 130'.It is within the scope of the present disclosure to utilize external positioners 130, 132, 134, 136 arranged as shown in FIGS. 2 to 4 and / or internal positioners 130', 134' arranged as shown in FIG. 24C.

[0027] Referring to FIGS. 2 to 4, skirt 120 can be moved between a contracted configuration and an expanded configuration in the radial and axial directions by the operation of actuator 118 on handle 112. Overall, the expansion may proceed as described above. Skirt 120 can contract in an overall reverse order (e.g., FIG. 4, FIG. 3, then FIG. 2). For example, starting from the expanded configuration shown in FIG. 4, actuator 118 may operate to extend positioner 130 distally, whereby positioner 130 can push the distal edge 122 of the skirt distally. As the distal edge 122 of skirt 120 moves distally, the distal opening 124 of skirt 120 can radially contract as shown in FIG. 3. As positioner 130 moves further distally, it can radially contract, such as inside inner tube 138. Positioner 130 may return skirt 120 to the contracted configuration as shown in FIG. 2.

[0028] In some exemplary embodiments, the skirt 120 may be constructed from wires, filaments, and / or strands 142 (such as Nitinol), which may be woven into a mesh-like mesh 144 and / or at least partially covered by a low magnetic permeability or substantially non-permeable cover 146 (such as silicone), whereby the skirt can be substantially fluid-sealed. It is within the scope of the present disclosure to utilize materials having similar properties other than Nitinol and / or silicone. For example, other materials having bending properties similar to Nitinol and / or other materials having elongation properties similar to silicone may be utilized. In some exemplary embodiments, at least a portion of the skirt 120 (such as the cover 146) may include a lubricious coating such as parylene. In some exemplary embodiments, the wires 142 forming the mesh 144 may be configured and / or oriented such that the skirt 120 expands radially in the expanded configuration (Figure 4) when axially shortened. For example, at least some of the wires 142 may be oriented at approximately 45 degrees with respect to the longitudinal axis 104 (Figure 1). In some exemplary embodiments, in the expanded configuration, some of the wires 142 may be oriented substantially circumferentially, such as near the distal edge 122. In some exemplary embodiments, in the expanded configuration, some of the wires 142 may be oriented substantially axially, such as near the distal end 108 of the tubular body 102.

[0029] With reference to FIGS. 5-10, an exemplary method of using a pericardial access system 10 (FIG. 1) according to at least some aspects of the present disclosure is described. FIG. 5 is a detailed side view of the distal end 108 of the tubular body 102, showing the rounded incision point 204 of the obturator / endoscope 200 that extends at least partially distally beyond the distal end 108 of the tubular body 102. FIG. 6 is a detailed side view of the distal end 108 of the tubular body 102 after the obturator / endoscope 200 has been retracted. FIG. 7 is a detailed side view of the distal end 108 of the tubular body 102, showing the skirt 120 in an expanded configuration. FIG. 8 is a detailed side cross-sectional view of the distal end 108 of the tubular body 102, showing the working end 302 of the needle guide system 300 extending from the distal end 108. FIG. 9 is a detailed side cross-sectional view of the distal end 108 of the tubular body 102, showing the guide wire 304 extending from the distal end 108. FIG. 10 is a detailed side view of the distal end 108 of the tubular body 102, showing the pericardial access device 100 being pulled away while leaving the guide wire 304 in place, all according to at least some aspects of the present disclosure.

[0030] Referring to FIG. 5, a pericardial access device 100 (FIG. 1) with an inserted obturator / endoscope 200 can be guided towards a target tissue such as the pericardium 400 to access the pericardial cavity 402. The at least partially transparent and rounded incision point 204 of the obturator / endoscope 200 can facilitate accessing and / or visualizing an appropriate access position on the pericardium 400. Additionally, fluoroscopy, ultrasound, and / or other imaging techniques can be utilized to guide the device 100 to a desired position near the pericardium 400. One or more components of the pericardial access device 100 can be constructed from a material that appears to use such imaging techniques and / or can include markers that appear to use such imaging techniques.

[0031] Referring to FIG. 6, the obturator / endoscope 200 can be at least partially retracted from the pericardial access device 100. For example, the obturator / endoscope 200 may be partially retracted such that the incision point 204 comes inside the channel 110. Referring to FIG. 7, the skirt 120 can be arranged in an expanded configuration as described above with reference to FIGS. 2-4. The distal edge 122 of the skirt 120 can be disposed in contact with the pericardium 400. The distal edge 122 of the skirt 120 can be configured to engage the outer surface of the pericardium 400 in a sealed manner.

[0032] Referring to FIG. 8, a suction force may be applied to the skirt 120, such as by the suction port 114 (FIG. 1) and / or the tubular body 102, whereby a portion of the pericardium 400 can be pulled proximally away from the underlying tissue (e.g., the heart) and into the skirt 120, resulting in displacement of the pericardium 400 from the epicardium 401 and formation of a movement range 403 that did not exist before. The needle guide system 300 may be inserted into the pericardial access device 100 (FIG. 1) while maintaining a suction force on the pericardium 400, such that its working end 302 extends distally beyond the distal end 108 of the tubular body 102. The hollow needle 310 of the needle guide system 300 may be extended to make a hole in the pericardium 400. Referring to FIGS. 4, 7, and 8, the generally frustoconical skirt 120 can include at least a partially curved (e.g., bell-shaped) outer profile, which can improve the strength of the skirt 120. For example, the distal portion of the skirt 120 can include a generally cylindrical portion near the distal edge 122. From there, the skirt 120 can bend radially inward and then proximally toward the distal end 108, becoming generally S-shaped. In particular, such a configuration of the generally cylindrical portion can improve the hoop strength of the skirt 120 and prevent collapse of the skirt 120 when a suction force is applied. Therefore, it is within the scope of the present disclosure for the generally frustoconical skirt 120 to include a curved outer profile.

[0033] Referring to FIG. 9, after making a hole in the pericardium 400, the guide wire 304 can be extended through the hollow needle 310 and the pericardium 400 into the pericardial cavity 402. When positioning the guide wire 304 through the pericardium 400, the needle 310 may be at least partially retracted. Thereafter, the suction force inside the skirt 120 may be released, allowing the pericardium 400 to be loosened and retracted distally from inside the skirt 120.

[0034] Referring to FIG. 10, the guide wire 304 may remain extended through the pericardium 400 into the pericardial cavity 402. The skirt 120 may be placed in a constricted configuration as described above with respect to FIGS. 2 - 4. The pericardial access device 100 may be repositioned away from the pericardium 400, leaving the guide wire 304 in place. The guide wire 304 can be used as required in procedures that require access to the epicardium, such as cardiac ablation for treating atrial fibrillation and / or occlusion of the left atrial appendage, which are known to those skilled in the art.

[0035] FIG. 11 is a flow diagram showing an exemplary method 500 for accessing the pericardium according to at least some aspects of the present disclosure. The reference numerals are given only by way of example, and the method is not necessarily tied to the particular structures referenced. Step 501 is a step of advancing the distal end 108 of the pericardial access device 100 towards the pericardium 400, such as through an incision or a trocar, and may include the step that the round incision point 204 of the obturator 200 extends distally from the distal end 108 of the pericardial access device 100. The advancing step may include the step of visualizing the pericardium 400 using an endoscope 210 disposed to observe through at least partially transparent incision point 204. Step 502 may include the step of at least partially retracting the point of the obturator 200 inside the pericardial access device 100. Step 503 is a step of repositioning a selectively deployable skirt 120 proximal to the distal end of the pericardial access device from a radially contracted configuration to a radially expanded configuration, and in the radially expanded configuration, the skirt 120 extends distally beyond the pericardial access device 100 and includes a distal edge 122 defining a distal opening, and the repositioning step may be included. The moving step may include the step of operating an actuator 118 on the handle 112 of the pericardial access device 100. The step of operating the actuator 118 may be a step of moving a positioner 130 coupled to the skirt 120 proximally, and may include the step of radially expanding the distal edge 122 of the skirt defining the distal opening 124. The distal opening of the skirt 120 may be wider than the distal end 108 of the tubular body 102 of the pericardial access device 100. Step 504 may include the step of sealingly engaging the distal edge 122 of the skirt to the pericardium 400. Step 505 may include the step of applying a suction force to the skirt 120 to draw a portion of the pericardium 400 proximally into the skirt 120, displacing the pericardium 400 from the epicardium 401 to form a previously non-existent movable range 403. Step 506 may include the step of inserting a needle guide system 300 into the pericardial access device 100 such that the working end 302 of the needle guide system 300 extends into the skirt 120.Procedure 507 may include puncturing the pericardium 400 by extending the hollow needle 310 of the needle guide system 300. Procedure 508 may include extending the guide wire 304 through the hollow needle 310 and into the pericardial cavity 402. Procedure 509 may include relieving the suction force at the skirt 120. The hollow needle 310 may be retracted before relieving the suction force at the skirt 120. Procedure 510 may include repositioning the skirt 120 from a radially expanded configuration to a radially contracted configuration. Procedure 511 may include detaching the pericardial access device 100 from the pericardium 400 while the guide wire 304 remains extended into the pericardial cavity 402.

[0036] Alternative examples of the pericardial access device 600 according to at least some aspects of the present disclosure are described in connection with FIGS. 12-25. FIG. 12 is a perspective view of an exemplary pericardial access device 600 in a closed configuration, FIG. 13 is a side view of an exemplary pericardial access device 600 in an open configuration including a distal surface that is generally inclined at a predetermined angle from the longitudinal axis of the tubular structure, FIG. 14 is a detailed cross-sectional perspective view of the distal end of an exemplary pericardial access device 600 in an open configuration, FIG. 15 is a detailed cross-sectional perspective view of the distal end of an exemplary pericardial access device 600 with the pericardial access needle extended, FIG. 16 is a detailed cross-sectional perspective view of the distal end of an exemplary pericardial access device 600 with the guide wire deployed, all according to at least some aspects of the present disclosure.

[0037] Referring to FIGS. 12-16, in some exemplary embodiments, the pericardial access device 600 may include an elongate tubular body 602 having a longitudinal axis 604, a proximal end 606, and / or a distal end 608. The tubular body 602 may include a longitudinal first channel 610 configured to receive an endoscope 612 and / or a longitudinal second channel 614 configured to receive a pericardial needle 616 that may be hollow. Some exemplary embodiments may be configured to use commercially available pericardial needles such as those known as Tuohy needles, Whitacare needles, and / or Sprotte needles.

[0038] In some exemplary embodiments, the pericardial access device 600 may include a repositionable tip 618 disposed at the distal end 608 of the tubular body 602. The tip 618 may include a substantially round cutting point 620 oriented distally. The tip 618 may be pivotally coupled to the tubular body 602 by a pivot connection 622. The pivot connection 622 may be disposed on the tubular body 602 near the distal end 608. One or more arms 624, 626 that the tip 618 may include may engage both lateral sides of the tubular body 602. For example, the pivot connection 622 may engage the proximal portions of the arms 624, 626. In some exemplary embodiments, at least one laterally extending protrusion disposed on the tubular body 602 and that may be included in the pivot connection 622 may be received into corresponding holes on one or more arms 624, 626 of the tip 618. In some exemplary embodiments, the pivot connection 622 may include such a protrusion / hole mechanism on both sides of the tubular body 602, such as protrusions corresponding to the holes of each of the arms 624, 626. Some exemplary embodiments may include an overall reverse mechanism and may include laterally inward protrusions configured to engage corresponding holes disposed on the tubular body 602 on one or more of the arms 624, 626. The pivot connection 622 may facilitate pivoting of the tip 618 about a tip pivot axis 628 that may be generally perpendicular to the longitudinal axis 604 of the tubular body 602.

[0039] In some exemplary embodiments, the tip 618 may be rotatable between a closed configuration (FIG. 12) and an open configuration (FIGS. 13-16). In the closed configuration, the tip 618 may substantially cover the distal end 608 of the tubular body 602. In the open configuration, the tip 618 may be disposed at least partially beside the distal end 608 of the tubular body 602 such that the distal surface 630 of the tubular body 602 is exposed. In some exemplary embodiments, the pericardial access device 600 may include one or more biasing members (such as a torsion spring) configured to bias the tip 618 in one direction toward the open configuration and / or the closed configuration. In some exemplary embodiments, the pericardial access device 600 may include one or more retention mechanisms associated with the tip 618 to releasably protect the tip 618 in the open configuration and / or the closed configuration. FIG. 24B is a side view of an exemplary pericardial access device 600 (which may be generally similar to the pericardial access device 600) including an exemplary retention mechanism 690 according to at least some aspects of the present disclosure. Generally, the retention mechanism 690 may include a spring arm 692 extending from the tip 618". The spring arm 690 may slidably engage a protrusion 694 formed on the tubular body 602" when the tip 618" rotates about the pivot connection 622". The spring arm 692 and / or the protrusion 694 may be shaped to correspond to the formation of an overcenter mechanism by the retention mechanism 690 to hold the tip 618" in the closed configuration and / or the open configuration. Other exemplary retention mechanisms may include frictional engagement and / or anti-rotation engagement between the tip 618 and the tubular body 602.

[0040] In the exemplary embodiments shown in FIGS. 12-16, the distal face 630 may be inclined with respect to the longitudinal axis 604 of the tubular body 602. Such a configuration may be advantageous for certain surgical procedures, access positions, and / or target anatomical structures. For example, in some environments, the inclined distal face 630 may be larger than a vertically oriented distal face and / or may facilitate a desired (e.g., more tangential) approach angle to the heart. FIG. 24 is a side view of an alternative exemplary pericardial access device 600' according to at least some aspects of the present disclosure, which may be generally similar to the pericardial access device 600 and may include a distal face 630' that is generally perpendicular to the longitudinal axis 604' of the tubular body 602'. Such a configuration may be advantageous for other surgical procedures, access positions, and / or target anatomical structures. It is within the scope of the present disclosure to utilize the distal faces 630, 630' at any angle with respect to the longitudinal axes 602, 602'.

[0041] In some exemplary embodiments, the tip 618 may be at least partially formed from a substantially transparent (e.g., optically transparent) material. For example, substantially the entire tip 618 may be formed from a substantially transparent plastic. Generally, materials suitable for some exemplary tips 618 may include biologically compatible, injection moldable, optically transparent plastics such as polycarbonate and / or acrylic resin. In some exemplary embodiments, other portions such as the incision point 620 and / or the arms 624, 626 of the tip 618 may be formed from a substantially transparent material or a non-transparent (e.g., translucent or opaque) material. In some exemplary embodiments, the at least partially transparent tip 618 may facilitate observation through the tip 618 using the endoscope 612 when the tip 618 is in the closed configuration. For example, in some surgical procedures, the surgeon may utilize the image obtained through the tip 618 by the endoscope 612 to guide the insertion of the pericardial access device 600, which may include a blunt dissection using the incision point 620.

[0042] Referring to FIGS. 14-16, in some exemplary embodiments, the first longitudinal channel 610 may be configured to receive the endoscope 612 and may include one or more stops 632. To prevent over-insertion of the endoscope 612, the stop 632 may generally be disposed distally within the first longitudinal channel 610. For example, a protrusion into a hole of the first longitudinal channel 610 that the stop 632 may include functions to prevent the endoscope 612 from moving distally beyond the stop 632.

[0043] In some exemplary embodiments, the distal end 608 (e.g., the distal surface 630) of the tubular body 602 may at least partially define a suction cavity 634. For example, the inner distal surface 636 may be recessed proximally relative to the distal surface 630 to form the suction cavity 634. The inner distal surface 636 may include openings for one or more channels such as the first longitudinal channel 610 and / or the second longitudinal channel 614 that extend through the tubular body 602. Some surgical devices such as the pericardial needle 616 and / or the guide wire 638 may be selectively extended distally beyond the inner distal surface 636. Some surgical devices such as the pericardial needle 616 may be configured to extend beyond the inner distal surface 636 without exceeding the distal surface 630. Some surgical devices such as the guide wire 638 may be configured to extend beyond the inner distal surface 636 and / or the distal surface 630. Some surgical devices such as the endoscope 612 may be configured to remain proximal to the inner distal surface 636 (e.g., by the action of the stop 632).

[0044] Referring to FIG. 15, in some exemplary embodiments, the pericardial access device 600 may be configured such that the pericardial needle 616 can rotate. For example, the needle 616 may extend, with an entirety of a one-sided surface (e.g., a flat surface 640) facing away from the inclined distal surface 630 (e.g., with an entirety of a rounded surface 644 facing towards the inclined distal surface 630), from the proximal to the inner distal surface 636 and into the suction cavity 634. The needle 616 may be rotated such that the flat surface 640 faces towards the inclined distal surface 630 (e.g., such that the rounded surface 644 faces away from the inclined distal surface 630). In some exemplary embodiments, an overall reverse approach may also be used. For example, the needle 616 may extend, with an entirety of another surface (e.g., a rounded surface 644) facing away from the inclined distal surface 630 (e.g., with an entirety of a flat surface 640 facing towards the inclined distal surface 630). The needle 616 may be rotated such that the rounded surface 644 faces towards the inclined distal surface 630 (e.g., such that the flat surface 640 faces away from the inclined distal surface 630). In some exemplary embodiments, rotating the needle 616 may facilitate piercing the pericardium 652 in a desired manner, may facilitate inserting the guide wire 638 in a desired direction, and / or may reduce the risk of the needle 616 extending into the heart tissue (e.g., the ventricle).

[0045] Referring to FIGS. 12-16, in some exemplary embodiments, the pericardial access device 600 may include a suction port 646 disposed generally proximally, which may be fluidly coupled to the suction cavity 634 by one or more of the first channel 610 and / or the second channel 614 or another longitudinal channel. For example, referring to FIGS. 14-16, in some exemplary embodiments, the tubular body 602 may include one or more additional longitudinal channels such as a third channel 648 and / or a fourth channel 650. One or more of the third channel 648 and the fourth channel 650 may be utilized, for example, to couple the suction port 646 to the suction cavity 634.

[0046] With reference to FIGS. 17-23, an exemplary method of using the pericardial access device 600 (FIG. 12) according to at least some aspects of the present disclosure is described. FIG. 17 is a detailed side view of the distal end 608 of the tubular body 602, showing the tip 618 in a closed configuration approaching the pericardium 652. FIG. 18 is a detailed side view of the distal end 608 of the tubular body 602 approaching the pericardium 652 in an open configuration. FIG. 19 is a detailed side view of the distal end 608 of the tubular body 602 in contact with the pericardium 652. FIG. 20 is a detailed side cross-sectional view of the distal end 608 of the tubular body 602, showing a portion of the pericardium 652 drawn into the suction cavity 634. FIG. 21 is a detailed side cross-sectional view of the distal end 608 of the tubular body 602, showing the needle 616 piercing the pericardium 652. FIG. 22 is a detailed side cross-sectional view of the distal end 608 of the tubular body 602, showing the guide wire 638 extending into the pericardial cavity 654. FIG. 23 is a detailed side view of the distal end 608 of the tubular body 602, showing the pericardial access device 600 being withdrawn while leaving the guide wire 638 in place, all according to at least some aspects of the present disclosure.

[0047] Referring to FIG. 17, a pericardial access device 600 having a distal tip 618 in a closed configuration can be directed towards a target tissue such as the pericardium 652 to access the pericardial cavity 654. The at least partially transparent and rounded distal tip 620 of the distal tip 618 can facilitate accessing and / or visualizing an appropriate access location on the pericardium 652. Additionally, fluoroscopy, ultrasound, and / or other imaging techniques can be utilized to direct the device 600 to a desired location near the pericardium 652. One or more components of the pericardial access device 600 may be constructed from a material that appears to use such imaging techniques and / or may include markers that appear to use such imaging techniques.

[0048] Referring to FIG. 18, the distal tip 618 can be rotated from a closed configuration to an open configuration. For example, the distal tip 618 may be laterally pressed against the pericardium 652 and / or another anatomical structure to rotate the distal tip 618 to the open configuration.

[0049] Referring to FIG. 19, the distal surface 630 can be disposed in contact with the pericardium 652. The distal surface 630 can be configured to engage the outer surface of the pericardium 652 in a sealed manner.

[0050] Referring to FIG. 20, a suction force may be applied to the suction cavity 634, such as by the suction port 646 (FIG. 12) and / or the tubular body 602, whereby a portion of the pericardium 652 can be pulled proximally away from the underlying tissue (e.g., the heart) and into the suction cavity 634. As a result, the pericardium 652 is displaced from the epicardium 653, forming a movement range 655 that did not exist previously.

[0051] Referring to FIG. 21, the pericardial needle 616 may extend distally through the pericardium 652 beyond the internal distal surface 636. In some exemplary embodiments, the needle 616 may direct the flat surface 640 generally in a direction opposite the inclined distal surface 630 (e.g., direct the rounded surface 644 generally toward the inclined distal surface 630) and extend proximally into the internal distal surface 636 and into the suction cavity 634 (e.g., through the pericardium 652). In some exemplary embodiments, other orientations and / or rotations of the needle 616 may be used.

[0052] Referring to FIG. 22, the needle 616 may be rotated such that the flat surface 640 is generally directed toward the inclined distal surface 630 (see also FIG. 15, e.g., the rounded surface 644 is generally directed in a direction opposite the inclined distal surface 630). In some exemplary embodiments, other orientations and / or rotations of the needle 616 may be used. The guide wire 638 may extend through the holes in the needle 616 and the pericardium 652 and into the pericardial cavity 654.

[0053] Referring to FIG. 23, the needle 616 may be at least partially retracted from the pericardium 652 and / or the device 600. The suction force inside the suction cavity 634 may be released, allowing the pericardium 652 to relax and retract distally out of the interior of the suction cavity 634. The guide wire 638 may remain extending through the pericardium 652 and into the pericardial cavity 654. The pericardial access device 600 may be detached from the pericardium 652, leaving the guide wire 638 in place. During detachment, the tip 618 may be rotated to a partially closed configuration. The guide wire 638 may be used as required in procedures that require access to the epicardium, such as, but not limited to, cardiac ablation and / or occlusion of the left atrial appendage for treating atrial fibrillation.

[0054] FIG. 25 is a flowchart showing an exemplary method 700 for accessing the pericardium according to at least some aspects of the present disclosure. The reference numerals are provided only by way of example, and the method is not necessarily tied to the particular structures referenced. Step 701 may include guiding a pericardial access device 600 including a tubular body 602 and a tip 618 toward the pericardium 652. The tip 618 may include a rounded incision point 620 and may be repositionable between a closed configuration and an open configuration. Step 702 may include visualizing the pericardium 652 using an endoscope 612 positioned to observe through an incision point 620 that may be at least partially transparent. In the closed configuration, the tip 618 may substantially cover the distal end 608 of the tubular body. During this step, the endoscope 612 may be positioned using a first channel 610 extending through the tubular body 602. Step 703 may include repositioning the tip 618 from the closed configuration to the open configuration. In the open configuration, the distal surface 630 of the tubular body 602 may be exposed. This step may include pressing the tip 618 laterally against an anatomical structure to reposition it to the open configuration and / or rotating it about a tip pivot axis 628. Step 704 may include sealingly engaging the distal surface 630 of the tubular body 602 with the pericardium 652. Step 705 may include applying a suction force to a suction cavity 634, at least partially defined by the distal surface 630, to displace a portion of the pericardium 652 from the epicardium 653 to form a previously non-existent movement range 655. Step 706 may include piercing the pericardium 652 by extending a pericardial needle 616 into the suction cavity 634. During this step, the pericardial needle 616 may be positioned inside a second channel 614 extending through the tubular body 602. This step may include rotating the pericardial needle 616. Step 707 may include extending a guidewire 638 through the pericardial needle 616 into the pericardial cavity 654. Step 708 may include releasing the suction force in the suction cavity 634. A step of retracting the pericardial needle 616 may precede this step.Procedure 709 may include separating the pericardial access device 600 from the pericardium 652 while extending the guide wire 638 into the pericardial cavity 654.

[0055] The methods and apparatuses described herein constitute exemplary embodiments according to the present disclosure in accordance with the above description and summary of the invention. However, it should be apparent to those skilled in the art that the scope of the present disclosure contained herein is not limited to the above exact embodiments and may be modified without departing from the scope as defined by the following claims. Similarly, although not explicitly discussed herein, there may be inherent and / or unforeseen advantages, so it should be understood that it is not necessary to meet any or all of the identified advantages or objectives disclosed herein in order to fall within the scope of the claims.

Description of Reference Numerals

[0056] 10 Pericardial access system 100 Pericardial access device 102 Tubular body 104 Longitudinal axis 106 Proximal end 108 Distal end 110 Channel 112 Handle 114 Suction port 116 Coupling 118 Actuator 120 Skirt 122 Distal edge 124 Distal opening 126 Width 128 Width 130 Positioner 132 Positioner 134 Positioner 136 Positioner 138 Inner tube 140 Distal end 142 Strand 144 Mesh 146 Cover 200 obturator / endoscope 202 working end 204 incision point 206 shaft 208 coupling 210 endoscope 300 needle guide system 302 working end 304 guide wire 306 shaft 308 coupling 310 needle 400 pericardium 401 epicardium 402 pericardial cavity 403 movable range 600 pericardial access device 602 tubular body 604 longitudinal axis 606 proximal end 608 distal end 610 first channel 612 endoscope 614 second channel 616 pericardial needle 618 tip 620 incision point 622 pivot connection part 624 arm 626 arm 628 tip pivot axis 630 distal surface 632 stop part 634 suction cavity 636 distal surface 638 guide wire 640 flat surface 644 rounded surface 646 suction port 648 third channel 650 fourth channel 652 pericardium 653 epicardium 654 pericardial cavity 655 movable range 690 holding mechanism 692 Spring Arm 694 Protrusion 100’ Pericardial Access Device 120’ Skirt 122’ Distal Edge 130’ Positioner 134’ Positioner 600’ Pericardial Access Device 602’ Tubular Body 604’ Longitudinal Axis 630’ Distal Surface 600” Pericardial Access Device 602” Tubular Body 618” Tip 622” Pivot Connection

Claims

1. A surgical device for accessing a patient's pericardial cavity, comprising: an elongated tubular body having a proximal end and a distal end, the tubular body including a longitudinal first channel configured to receive an endoscope and a longitudinal second channel configured to receive a pericardial needle; a distal tip disposed at the distal end of the tubular body, the tip being at least partially transparent and repositionable, the tip including a rounded incision point directed distally and a proximal repositionable connector, the proximal repositionable connector being repositionably engaged with the tubular body near the distal end of the tubular body such that the tip can be repositioned between a closed configuration and an open configuration; and wherein in the closed configuration, the tip substantially covers the distal end of the tubular body and extends distally beyond the distal end of the tubular body; a surgical device, wherein in the open configuration, the tip is disposed at least partially beside the distal end of the tubular body such that the distal surface of the tubular body is exposed.

2. The device of claim 1, wherein the proximal repositionable connector comprises a pivot connector, and the tip is rotatable between the closed configuration and the open configuration about a tip pivot axis that is generally perpendicular to the longitudinal axis of the tubular body.

3. The device of claim 1, wherein the distal end of the tubular body comprises a distal end surface that is inclined with respect to the longitudinal axis of the tubular body.

4. The device of claim 1, wherein the distal end of the tubular body comprises a distal end surface that is generally perpendicular to the longitudinal axis of the tubular body.

5. The device of claim 1, wherein the longitudinal first channel comprises a stop disposed to limit distal movement of the endoscope.

6. The device of claim 1, wherein the pericardial needle does not extend beyond the distal surface of the tubular body.

7. The device of claim 1, wherein the pericardial needle is rotatable.

8. The device of claim 1, further comprising a longitudinal third channel fluidly coupled to a suction port near the proximal end of the tubular body.

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