Patent Description:
<CIT> discloses tools and methods for epicardial access.

The surgical device according to the invention is defined in claim <NUM>. The present disclosure is further directed to medical instruments and devices, and, more specifically, to surgical devices for accessing a pericardial space. The methods of operation disclosed are not covered by the wording of the claims, and their disclosure is considered useful for understanding the invention.

In an example, there is provided a surgical device for accessing a pericardial space of a patient including an elongated, 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 capable of selectively accepting an obturator and a needle guide system therein; a handle disposed at the proximal end of the tubular body; and/or a selectively deployable suction skirt movable between a retracted configuration in which the skirt is radially contracted and an extended configuration in which the skirt is radially expanded and includes a distal edge defining a distal opening. In the extended configuration, the distal edge of the skirt may be configured to sealingly engage a surface of a tissue layer, the distal opening of the skirt may be diametrically wider than the distal end of the tubular body, and/or the skirt may be configured to accept a portion of the tissue layer proximally therein when suction is applied to the skirt via the tubular body.

In the retracted configuration, the skirt may be at least partially within the tubular body and, in the extended configuration, the skirt may extend distally beyond the distal end of the tubular body. In the extended configuration, the skirt may be generally frustoconical. The skirt may include at least one positioner operatively coupled an actuator disposed on the handle, wherein the at least one positioner may be configured to move the skirt between the retracted configuration and the extended configuration. When moving from the retracted configuration to the extended configuration, the at least one positioner may move the skirt distally and/or expand the skirt radially. In the extended configuration, a width of the distal opening of the skirt may be at least about <NUM> times a width of the distal end of the tubular body. The obturator may include a distally oriented, at least partially transparent, blunt-tipped dissecting point and/or an endoscope arranged to view through the point. The skirt may be constructed of nitinol wires braided into a mesh and/or may be at least partially covered in silicone. At least some of the wires of the mesh may be oriented at about <NUM> degrees with respect to a longitudinal axis of the tubular body such that pulling proximally on the distal edge of the skirt causes the skirt to expand radially.

In an example, there is provided a method of obtaining pericardial access including advancing a distal end of a pericardial access device towards a pericardium, wherein a blunt dissecting point of an obturator extends distally from the distal end of the pericardial access device; withdrawing the point of the obturator at least partially within the pericardial access device; repositioning a selectively deployable skirt proximate a distal end of the pericardial access device from a retracted radial configuration to an extended radial configuration, wherein, in the extended radial configuration, the skirt extends distally beyond the pericardial access device and includes a distal edge defining a distal opening; sealingly engaging the distal edge of the skirt against the pericardium; drawing a portion of the pericardium proximally into the skirt by applying suction to the skirt so that the pericardium is displaced from an epicardium to form a working volume not otherwise present; inserting a needle guide system into the pericardial access device so that a working end of the needle guide system extends into the skirt; puncturing the pericardium by extending a hollow needle of the needle guide system; extending a guide wire through the hollow needle and into a pericardial space; releasing suction on the skirt; repositioning the skirt from the extended radial configuration to the retracted radial configuration; and/or withdrawing the pericardial access device away from the pericardium while leaving the guide wire extending into the pericardial space.

Repositioning the selectively deployable skirt from the retracted radial configuration to the extended radial configuration may include extending the skirt distally and/or repositioning the skirt from the extended radial configuration to the retracted radial configuration may include retracting the skirt proximally. The advancing operation may include visualizing the pericardium using an endoscope arranged to view through the dissecting point, the dissecting point being at least partially transparent. Repositioning the selectively deployable skirt may include operating an actuator on a handle of the pericardial access device. The distal opening of the skirt may be wider than the distal end of a tubular body of the pericardial access device. The method may include, prior to releasing suction on the skirt, withdrawing the hollow needle.

There is provided a surgical device for accessing a pericardial space of a patient including an elongated, tubular body including a proximal end and a distal end, the tubular body including a longitudinal first channel configured to accept an endoscope therein and a longitudinal second channel configured to accept a pericardial needle therethrough; and/or an at least partially transparent, repositionable tip disposed at the distal end of the tubular body, the tip including a substantially blunt, distally oriented dissection point and a proximal repositionable connector, the proximal repositionable connector repositionably engaging the tubular body near the distal end of the tubular body so that the tip is repositionable 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 may extend distally beyond the distal end of the tubular body. In the open configuration, the tip may be positioned at least partially beside the distal end of the tubular body so that a distal face of the tubular body is exposed.

The proximal repositionable connector may include a pivot connector and/or the tip may be pivotable about a tip pivot axis that is generally perpendicular to a longitudinal axis of the tubular body between the closed configuration and the open configuration. 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 a longitudinal axis of the tubular body. The first longitudinal channel may include a stop, the stop being positioned to limit distal movement of the endoscope. The pericardial needle may not extend beyond the distal face of the tubular body. The pericardial needle may be rotatable. The device may include a longitudinal third channel, the third channel being fluidicly coupled to a suction port near the proximal end of the tubular body.

In an example, there is provided a method of obtaining pericardial access including directing a pericardial access device including a tubular body and a tip towards a pericardium, the tip being repositionable between a closed configuration and an open configuration and including a blunt-tipped dissecting point; visualizing the pericardium using an endoscope arranged to view through the dissecting point, the dissecting point being at least partially transparent; repositioning the tip from the closed configuration to the open configuration, wherein, in the open configuration, a distal face of the tubular body is exposed; sealingly engaging the distal face of the tubular body against the pericardium; drawing a portion of the pericardium into a suction cavity defined at least partially by the distal face by applying suction to the suction cavity so that the pericardium is displaced from an epicardium to form a working volume not otherwise present; puncturing the pericardium by extending a pericardial needle into the suction cavity; extending a guide wire through the pericardial needle into a pericardial space; releasing suction on the suction cavity; and/or withdrawing the pericardial access device away from the pericardium while leaving the guide wire extending into the pericardial space.

Repositioning the tip from the closed configuration to the open configuration may include pivoting the tip about a tip pivot axis. During the visualizing operation, the endoscope may be positioned within a first channel extending through the tubular body and/or, during the puncturing operation, the pericardial needle may be positioned within a second channel extending through the tubular body. The method may include, prior to releasing suction on the suction cavity, withdrawing the pericardial needle. The repositioning operation may include pressing the tip laterally against an anatomical structure to reposition the tip to the open configuration. In the closed configuration, the tip may substantially cover a distal end of the tubular body. The puncturing operation may include rotating the pericardial needle.

There may be provided any apparatus, or combination thereof as disclosed herein.

Example embodiments are described in conjunction with the accompanying drawing figures in which:.

Example embodiments according to the present disclosure are described and illustrated below to encompass devices, methods, and techniques relating to medical procedures. Of course, it will be apparent to those of ordinary skill in the art that the embodiments discussed below are examples and may be reconfigured without departing from the scope of the present disclosure. It is also to be understood that variations of the example embodiments contemplated by one of ordinary skill in the art shall concurrently comprise part of the instant disclosure. However, for clarity and precision, the example embodiments as discussed below may include optional steps, methods, and features that one of ordinary skill should recognize as not being a requisite to fall within the scope of the present disclosure.

The present disclosure includes, inter alia, medical devices and instruments and related methods, and, more specifically, surgical instruments and related methods that may be used to provide pericardial access. The present disclosure contemplates that in connection with some surgical procedures, such as minimally invasive procedures (e.g., endoscopic procedures), it may be necessary to obtain access to internal anatomic structures that may be covered by a layer of tissue. For example, in connection with some minimally invasive heart surgeries, it may be necessary to penetrate the pericardium to allow surgical instruments to directly access the epicardium. Example minimally invasive cardiac procedures requiring access to the epicardium may include cardiac ablation to treat atrial fibrillation and occlusion of the left atrial appendage.

The present disclosure contemplates that it may be desirable to improve safety and/or ease of use of some existing surgical instruments and methods associated with obtaining pericardial access. For example, it may be desirable to provide apparatus and methods that allow a surgeon to reach a desired pericardial access point and accommodate patient anatomic differences, limit trauma to adjacent anatomical structures (e.g., during insertion, manipulation, and/or removal), and/or allow visualization of various aspects (e.g., device placement, pericardial surface, and/or adjacent structures).

<FIG> is a side elevation view of an example pericardial access system <NUM>. System <NUM> may include a pericardial access device <NUM>, which may be configured for use in connection with an obturator/endoscope <NUM> and/or a needle guide system <NUM>.

In some example embodiments, device <NUM> may include an elongated, generally tubular body <NUM> having a longitudinal axis <NUM>, a proximal end <NUM>, and/or a distal end <NUM>. Body <NUM> may include at least one longitudinal channel <NUM> (<FIG>) extending therethrough from proximal end <NUM> to distal end <NUM>. Although the following description refers to channel <NUM>, some example embodiments may include a plurality of similar longitudinal channels. A handle <NUM> may be disposed at the proximal end <NUM> of tubular body <NUM>. A suction port <NUM> may be fluidicly coupled to channel <NUM> to draw a vacuum through the at least one longitudinal channel <NUM> when a suction source is coupled to suction port <NUM>.

In some example embodiments, channel <NUM> may be configured to accept obturator/endoscope <NUM> therein. When inserted in channel <NUM>, a working end <NUM> of obturator/endoscope <NUM> may extend distally from distal end <NUM> of device <NUM>. For example, obturator/endoscope <NUM> may include a distally oriented, at least partially transparent, blunt-tipped dissecting point <NUM> disposed at a distal end of a shaft <NUM>. Point <NUM> may extend at least partially distally from distal end <NUM> of tubular body <NUM> of device <NUM> when obturator/endoscope <NUM> is inserted therein (see also <FIG>). Obturator/endoscope <NUM> may include a coupling <NUM>, which may be configured to releasably engage a corresponding coupling <NUM> on a proximal portion of handle <NUM>. Obturator/endoscope <NUM> may include an endoscope <NUM> arranged to view through point <NUM>.

In some example embodiments, channel <NUM> may be configured to accept needle guide system <NUM> therein. When inserted in channel <NUM>, a working end <NUM> of needle guide system <NUM> may extend distally from distal end <NUM> of tubular body <NUM> of device <NUM> (see <FIG> and <FIG>). Needle guide system <NUM> may be configured to insert a guide wire <NUM> into the pericardial space through a shaft <NUM> and via channel <NUM> when device <NUM> accepts needle guide system <NUM>. Needle guide system <NUM> may include a coupling <NUM>, which may be configured to releasably engage corresponding coupling <NUM> on the proximal portion of handle <NUM>.

In some example embodiments, handle <NUM> may include an actuator <NUM>, such as a rotatable knob, configured to reposition a movable feature of device <NUM>. <FIG> are perspective views of distal end <NUM> of device <NUM> showing an example selectively deployable skirt <NUM> movable between a retracted configuration (<FIG>), an intermediate configuration (<FIG>), and/or an extended configuration (<FIG>). In some example embodiments, in the retracted configuration, skirt <NUM> may be at least partially within tubular body <NUM>.

In some example embodiments, in the extended configuration, skirt <NUM> may extend distally beyond distal end <NUM> of tubular body <NUM>. In the extended configuration, skirt <NUM> may have a generally frustoconical shape and/or may have a distal edge <NUM> defining a distal opening <NUM> having a width <NUM>. In the extended configuration, width <NUM> of distal opening <NUM> may be greater than a width <NUM> of tubular body <NUM>. For example, width <NUM> of distal opening <NUM> of skirt <NUM> may be at least about <NUM> times, at least about <NUM> times, at least about <NUM> times, at least about <NUM> times, and/or at least about <NUM> times width <NUM> of tubular body <NUM>. In some example, embodiments, such as the illustrative embodiment shown in <FIG>, distal opening <NUM> of skirt <NUM> may be about <NUM> to <NUM> times width <NUM> of tubular body <NUM>.

In some example embodiments, skirt <NUM> may be movable between the retracted configuration (<FIG>) and the extended configuration (<FIG>) by at least one positioner <NUM>, <NUM>, <NUM>, <NUM>, which may be operably coupled to actuator <NUM> of handle <NUM>. In the retracted configuration, skirt <NUM> may be radially contracted. In the extended configuration, skirt <NUM> may be radially expanded. For clarity, the following description of the extension and retraction of skirt <NUM> focuses on positioner <NUM>; however, it is to be understood that other positioners <NUM>, <NUM>, <NUM> (if any) may operate in a similar manner.

Referring to <FIG>, showing skirt <NUM> in the retracted configuration, skirt <NUM> may be positioned wholly or substantially within tubular body <NUM>. For example, skirt <NUM> may be positioned within an inner tube <NUM>, which may be disposed wholly or substantially within and/or extend distally from tubular body <NUM>. Positioner <NUM> may extend from outside of inner tube <NUM>, may fold around a distal end <NUM> of inner tube <NUM>, and/or may extend proximally to skirt <NUM> within inner tube <NUM>. In some example embodiments, positioner may be coupled to skirt <NUM> at or near distal edge <NUM> (<FIG>).

Referring to <FIG>, showing the intermediate configuration, repositioning positioner <NUM> proximally (e.g., by action of actuator <NUM>) may cause positioner <NUM> to radially expand and/or extend distally from inner tube <NUM>. This movement of positioner <NUM> may pull skirt <NUM> distally outward from inner tube <NUM>.

Referring to <FIG>, showing the extended configuration, further withdrawing positioner <NUM> proximally (e.g., by action of actuator <NUM>) may cause positioner <NUM> to further widen distal opening <NUM>, such as to make width <NUM> of distal opening <NUM> greater than width <NUM> of tubular body <NUM>. In some example embodiments, withdrawing positioner <NUM> proximally (e.g., by action of actuator <NUM>) may cause positioner <NUM> to pull distal edge <NUM> of skirt <NUM> proximally, axially shortening skirt <NUM>. Skirt <NUM> may be constructed so that axial shortening causes radial expansion, generally in a manner similar to a device known as a "Chinese finger trap" (e.g., a cylindrical, helically wound biaxial braid that radially narrows under axial tension and radially expands under axial compression). Accordingly, in the extended configuration, width <NUM> of distal opening <NUM> may be greater than a width <NUM> of tubular body <NUM>. In some example embodiments, one or more of positioners <NUM>, <NUM><NUM>, <NUM> may be selectively controllable (e.g., extendable and/or retractable) so that distal edge <NUM> of skirt <NUM> may be tilted, angled, and/or biased with respect to longitudinal axis <NUM>, which may facilitate sealingly engaging distal edge <NUM> of skirt <NUM> with a pericardium <NUM>, as described below (<FIG>). For example, one or more of positioners <NUM>, <NUM><NUM>, <NUM> may be further retracted while other positioners <NUM>, <NUM><NUM>, <NUM> are not further retracted and/or are extended, thus causing distal edge <NUM> to tilt generally towards the positioner(s) <NUM>, <NUM><NUM>, <NUM> that were retracted. <FIG> is a detailed cutaway perspective view of a distal end <NUM>' of an example pericardial access device <NUM>' (which may be generally similar to pericardial access device <NUM>, showing an angled skirt <NUM>'. In <FIG>, positioner <NUM>' has been further retracted and/or positioner <NUM>' has been further extended, thereby angling distal edge <NUM>' of skirt <NUM>' toward positioner <NUM>'. It is within the scope of the disclosure to utilize externally disposed positioners <NUM>, <NUM>, <NUM>, <NUM> as shown in <FIG> and/or internally disposed positioners <NUM>', <NUM>' as shown in <FIG>.

Referring to <FIG>, skirt <NUM> may be moved between the radially and axially retracted and extended configurations by operation of actuator <NUM> on handle <NUM>. Generally, extension may proceed as described above. Skirt <NUM> may be retracted in generally the opposite sequence (e.g., <FIG>, then <FIG>). For example, beginning in the extended configuration shown in <FIG>, actuator <NUM> may be operated to extend positioner <NUM> distally, which may cause positioner <NUM> to push distal edge <NUM> of skirt distally. Distal movement of distal edge <NUM> of skirt <NUM> may cause radial contraction of distal opening <NUM> of skirt <NUM> as shown in <FIG>. Further distal movement of positioner <NUM> may cause positioner <NUM> to radially contract, such as within inner tube <NUM>. Positioner <NUM> may return skirt <NUM> to the retracted configuration as shown in <FIG>.

In some example embodiments, skirt <NUM> may be constructed of wires, filaments, and/or strands <NUM> (e.g., nitinol), which may be woven into a braided mesh <NUM>, and/or which may be at least partially covered by a low permeability or substantially non-permeable covering <NUM> (e.g., silicone), which may make skirt substantially fluid tight. It is within the scope of the disclosure to utilize materials other than nitinol and/or silicone that have similar properties. For example, other materials having similar bending characteristics to nitinol and/or other materials having similar elongation characteristics to silicone may be utilized. In some example embodiments, at least a portion of skirt <NUM> (e.g., covering <NUM>) may include a lubricious coating, such as parylene. In some example embodiments, wires <NUM> forming mesh <NUM> may be configured and/or oriented so that axial shortening of skirt <NUM> causes radial expansion of skirt <NUM> in the extended configuration (<FIG>). For example, at least some of wires <NUM> may be oriented at about <NUM> degrees relative to longitudinal axis <NUM> (<FIG>). In some example embodiments, in the extended configuration, some wires <NUM>, such as near distal edge <NUM>, may be nearly circumferentially oriented. In some example embodiments, in the extended configuration, some wires <NUM>, such as near distal end <NUM> of tubular body <NUM>, may be nearly axially oriented.

An example method of using pericardial access system <NUM> (<FIG>) is described with reference to <FIG>. <FIG> is a detailed side elevation view of distal end <NUM> of tubular body <NUM> showing blunt dissecting point <NUM> of obturator/endoscope <NUM> extending at least partially distally beyond distal end <NUM> of tubular body <NUM>, <FIG> is a detailed side elevation view of distal end <NUM> of tubular body <NUM> after obturator/endoscope <NUM> has been withdrawn, <FIG> is a detailed side elevation view of distal end <NUM> of tubular body <NUM> showing skirt <NUM> in the extended configuration, <FIG> is a detailed side elevation cutaway view of distal end <NUM> of tubular body <NUM> showing working end <NUM> of needle guide system <NUM> extending therefrom, <FIG> is a detailed side elevation cutaway view of distal end <NUM> of tubular body <NUM> showing guide wire <NUM> extending therefrom, and <FIG> is a detailed side elevation view of distal end <NUM> of tubular body <NUM> showing withdrawal of pericardial access device <NUM> leaving guide wire <NUM> in place.

Referring to <FIG>, pericardial access device <NUM> with obturator/endoscope <NUM> inserted therein (<FIG>) may be directed towards a target tissue, such as a pericardium <NUM>, to obtain access to a pericardial space <NUM>. At least partially transparent, blunt-tipped dissecting point <NUM> of obturator/endoscope <NUM> may facilitate obtaining access to and/or visualizing an appropriate access location on pericardium <NUM>. Additionally, fluoroscopy, ultrasound, and/or other imaging technologies may be utilized to guide device <NUM> into the desired position proximate pericardium <NUM>. One or more components of pericardial access device <NUM> may be constructed of materials that are visible using such imaging technologies and/or may include markers that are visible using such imaging technologies.

Referring to <FIG>, obturator/endoscope <NUM> may be at least partially withdrawn from pericardial access device <NUM>. For example, obturator/endoscope <NUM> may be partially withdrawn so that dissecting point <NUM> may be within channel <NUM>. Referring to <FIG>, skirt <NUM> may be placed into the extended configuration as described above with reference to <FIG>. Distal edge <NUM> of skirt <NUM> may be placed against pericardium <NUM>. Distal edge <NUM> of skirt <NUM> may be configured to sealingly engage the outer surface of pericardium <NUM>.

Referring to <FIG>, suction may be applied to skirt <NUM>, such as via suction port <NUM> (<FIG>) and/or tubular body <NUM>, which may pull a portion of pericardium <NUM> proximally into skirt <NUM> and away from underlying tissues (e.g., the heart) so that the pericardium <NUM> is displaced from an epicardium <NUM> to form a working volume <NUM> not otherwise present. Needle guide system <NUM> may be inserted into pericardial access device <NUM> (<FIG>) while suction continues to be applied to pericardium <NUM> so that its working end <NUM> extends distally beyond distal end <NUM> of tubular body <NUM>. A hollow needle <NUM> of needle guide system <NUM> may be extended to puncture pericardium <NUM>. Referring to <FIG>, <FIG>, generally frustoconical skirt <NUM> may include an at least partially curved outside profile (e.g., a bell shape), which may improve the strength of skirt <NUM>. For example, a distal portion of skirt <NUM> may include a generally cylindrical portion proximate distal edge <NUM>. From there, skirt <NUM> may curve radially inward and then proximally towards distal end <NUM> generally in an S-shape. Such a configuration, particularly the generally cylindrical portion, may increase the hoop strength of skirt <NUM>, which may prevent collapse of skirt <NUM> when suction is applied. Accordingly, it is within the scope of the disclosure for generally frustoconical skirt <NUM> to include a curved outside profile.

Referring to <FIG>, post puncturing pericardium <NUM>, guide wire <NUM> may be extended through hollow needle <NUM> and through pericardium <NUM> into pericardial space <NUM>. Upon positioning guide wire <NUM> through pericardium <NUM>, needle <NUM> may be at least partially withdrawn. Suction within skirt <NUM> may thereafter be released, allowing pericardium <NUM> to relax and withdraw distally from within skirt <NUM>.

Referring to <FIG>, guide wire <NUM> may remain extending into pericardial space <NUM> through pericardium <NUM>. Skirt <NUM> may be placed in the retracted configuration as described above with respect to <FIG>. Pericardial access device <NUM> may be repositioned away from pericardium <NUM>, leaving guide wire <NUM> in place. Guide wire <NUM> may be utilized as desired in connection with procedures requiring access to the epicardium, such as cardiac ablation to treat atrial fibrillation and/or occlusion of the left atrial appendage, such procedures being known to those skilled in the art.

<FIG> is a flow diagram illustrating an example method <NUM> of obtaining pericardial access. The reference numerals are provided only in exemplary fashion and the method is not necessarily tied to the specific structures referenced. Operation <NUM> may include advancing the distal end <NUM> of a pericardial access device <NUM> towards a pericardium <NUM>, such as through an incision or a trocar, wherein a blunt dissecting point <NUM> of an obturator <NUM> extends distally from the distal end <NUM> of the pericardial access device <NUM>. The advancing operation may include visualizing the pericardium <NUM> using an endoscope <NUM> arranged to view through the dissecting point <NUM>, the dissecting point <NUM> being at least partially transparent. Operation <NUM> may include withdrawing the point of the obturator <NUM> at least partially within the pericardial access device <NUM>. Operation <NUM> may include repositioning a selectively deployable skirt <NUM> proximate a distal end of the pericardial access device from a radial retracted configuration to an extended radial configuration, wherein, in the extended radial configuration, the skirt <NUM> extends distally beyond the pericardial access device <NUM> and includes a distal edge <NUM> defining a distal opening <NUM>. The moving operation may include operating an actuator <NUM> on a handle <NUM> of the pericardial access device <NUM>. Operating the actuator <NUM> may include moving proximally a positioner <NUM> coupled to the skirt <NUM>, which may radially expand the distal edge <NUM> of the skirt defining the distal opening <NUM>. The distal opening of the skirt <NUM> may be wider than the distal end <NUM> of a tubular body <NUM> of the pericardial access device <NUM>. Operation <NUM> may include sealingly engaging a distal edge <NUM> of the skirt against the pericardium <NUM>. Operation <NUM> may include drawing a portion of the pericardium <NUM> proximally into the skirt <NUM> by applying suction to the skirt <NUM> so that the pericardium <NUM> is displaced from an epicardium <NUM> to form a working volume <NUM> not otherwise present. Operation <NUM> may include inserting a needle guide system <NUM> into the pericardial access device <NUM> so that a working end <NUM> of the needle guide system <NUM> extends into the skirt <NUM>. Operation <NUM> may include puncturing the pericardium <NUM> by extending a hollow needle <NUM> of the needle guide system <NUM>. Operation <NUM> may include extending a guide wire <NUM> through the hollow needle <NUM> and into the pericardial space <NUM>. Operation <NUM> may include releasing suction on the skirt <NUM>. Prior to releasing suction on the skirt <NUM>, the hollow needle <NUM> may be withdrawn. Operation <NUM> may include repositioning the skirt <NUM> from the extended radial configuration to the retracted radial configuration. Operation <NUM> may include withdrawing the pericardial access device <NUM> away from the pericardium <NUM> while leaving the guide wire <NUM> extending into the pericardial space <NUM>.

An alternative example pericardial access device <NUM> is described in connection with <FIG>. <FIG> is a perspective view of pericardial access device <NUM> in a closed configuration, <FIG> is a side elevation view of pericardial access device <NUM> in an open configuration and including a distal face that is generally inclined at an angle from the longitudinal axis of the tubular structure, <FIG> is a detailed cutaway perspective view of a distal end of pericardial access device <NUM> in the open configuration, <FIG> is a detailed cutaway perspective view of the distal end of pericardial access device <NUM> with a pericardial access needle extended, and <FIG> is a detailed cutaway perspective view of the distal end of pericardial access device <NUM> with a guide wire deployed,.

Referring to <FIG>, in some example embodiments, pericardial access device <NUM> may include an elongated, tubular body <NUM> having a longitudinal axis <NUM>, a proximal end <NUM>, and/or a distal end <NUM>. Tubular body <NUM> may include a longitudinal first channel <NUM> configured to accept an endoscope <NUM> therein and/or a longitudinal second channel <NUM> configured to accept a pericardial needle <NUM>, which may be hollow. Some example embodiments may be configured for use with commercially available pericardial needles, such as those known as Tuohy, Whitacare, and/or Sprotte needles.

In some example embodiments, pericardial access device <NUM> may include a repositionable tip <NUM> disposed at distal end <NUM> of tubular body <NUM>. Tip <NUM> may include a substantially blunt, distally oriented dissection point <NUM>. Tip <NUM> may be pivotably coupled to tubular body <NUM> by a pivot connection <NUM>. Pivot connection <NUM> may be disposed on tubular body <NUM> near distal end <NUM>. Tip <NUM> may include one or more arms <NUM>, <NUM>, which may engage laterally opposing sides of tubular body <NUM>. For example, pivot connection <NUM> may engage proximal portions of arms <NUM>, <NUM>. In some example embodiments, pivot connection <NUM> may include at least one laterally extending boss disposed on tubular body <NUM> that may be received within a corresponding hole on one or more arms <NUM>, <NUM> of tip <NUM>. In some example embodiments, pivot connection <NUM> may include such a boss/hole arrangement on opposed lateral sides of tubular body <NUM>, such as a boss corresponding to a hole on each of arms <NUM>, <NUM>. Some example embodiments may include a generally opposite arrangement: one or more of arms <NUM>, <NUM> may include a laterally inwardly facing boss arranged to engage a corresponding hole disposed on tubular body <NUM>. Pivot connection <NUM> may facilitate pivoting tip <NUM> about a tip-pivot axis <NUM> that may be generally perpendicular to longitudinal axis <NUM> of tubular body <NUM>.

In some example embodiments, tip <NUM> may be pivotable between a closed configuration (<FIG>) and an open configuration (<FIG>). In the closed configuration, tip <NUM> may substantially cover distal end <NUM> of tubular body <NUM>. In the open configuration, tip <NUM> may be positioned at least partially beside distal end <NUM> of tubular body <NUM> so that a distal face <NUM> of tubular body <NUM> is exposed. In some example embodiments, pericardial access device <NUM> may include one or more biasing member (e.g., a torsion spring) arranged to bias tip <NUM> towards the open configuration and/or the closed configuration. In some example embodiments, pericardial access device <NUM> may include one or more retention features associated with tip <NUM> to releasably secure tip <NUM> in the open configuration and/or the closed configuration. <FIG> is a side elevation view of an example pericardial access device <NUM>" (which may be generally similar to pericardial access device <NUM>) including an example retention feature <NUM>. Generally, retention feature <NUM> may include a spring arm <NUM> extending from tip <NUM>". Spring arm <NUM> may slidably engage a boss <NUM> formed on tubular body <NUM>" as tip <NUM>" pivots about pivot connection <NUM>". Spring arm <NUM> and/or boss <NUM> may be correspondingly shaped so that retention feature <NUM> forms an over-center mechanism to retain tip <NUM>" in the closed configuration and/or the open configuration. Other example retention features may include friction and/or detent engagements between tip <NUM> and tubular body <NUM>.

In the example embodiment illustrated in <FIG>, distal face <NUM> may be inclined with respect to longitudinal axis <NUM> of tubular body <NUM>. Such a configuration may be advantageous for certain surgical procedures, access locations, and/or target anatomies. For example, in some circumstances, an inclined distal face <NUM> may be advantageous because it may be larger than a perpendicularly oriented distal face and/or because it may facilitate a desired approach angle to the heart (e.g., more tangential). <FIG> is a side elevation view of an alternative example pericardial access device <NUM>', which may be generally similar to pericardial access device <NUM>, and which may include a distal face <NUM>' that is generally perpendicular to a longitudinal axis <NUM>' of a tubular body <NUM>'. Such a configuration may be advantageous for other surgical procedures, access locations, and/or target anatomies. It is within the scope of the disclosure to utilize a distal face <NUM>, <NUM>' at any angle with respect to longitudinal axis <NUM>, <NUM>'.

In some example embodiments, tip <NUM> may be at least partially formed of a substantially transparent (e.g., optically clear) material. For example, substantially the entirety of tip <NUM> may be formed of a substantially transparent plastic. Generally, some example suitable materials for tip <NUM> may include biocompatible, injection moldable, optically clear plastics, such as polycarbonates and/or acrylics. In some example embodiments, dissection point <NUM> and/or other parts of tip <NUM>, such as arms <NUM>, <NUM>, may be formed from a substantially transparent material or a non-transparent (e.g., translucent and/or opaque) material. In some example embodiments, an at least partially transparent tip <NUM> may facilitate viewing through tip <NUM> using endoscope <NUM> when tip <NUM> is in the closed configuration. For example, in some surgical procedures, a surgeon may utilize the images obtained by endoscope <NUM> through tip <NUM> to guide insertion of pericardial access device <NUM>, which may include blunt dissection using dissection point <NUM>.

Referring to <FIG>, in some example embodiments, longitudinal first channel <NUM>, which may be configured to accept endoscope <NUM> therein, may include one or more stops <NUM>. Stop <NUM> may be disposed generally distally in first longitudinal channel <NUM> to prevent over-insertion of endoscope <NUM>. For example, stop <NUM> may include a projection into the bore of first longitudinal channel <NUM> that is operative to obstruct distal movement of endoscope <NUM> beyond stop <NUM>.

In some example embodiments, distal end <NUM> of tubular body <NUM> (e.g., distal face <NUM>) may at least partially define a suction cavity <NUM>. For example, an internal distal face <NUM> may be recessed proximally with respect to distal face <NUM> to form suction cavity <NUM>. Internal distal face <NUM> may include openings for one or more channels extending though tubular body <NUM>, such as first longitudinal channel <NUM> and/or second longitudinal channel <NUM>. Some surgical devices, such as pericardial needle <NUM> and/or a guide wire <NUM>, may be selectively extended distally beyond internal distal face <NUM>. Some surgical devices, such as pericardial needle <NUM>, may be configured for extension beyond internal distal face <NUM> but not beyond distal face <NUM>. Some surgical devices, such as guide wire <NUM>, may be configured for extension beyond internal distal face <NUM> and/or distal face <NUM>. Some surgical devices, such as endoscope <NUM>, may be configured to remain proximal to internal distal face <NUM> (e.g., by operation of stop <NUM>).

Referring to <FIG>, in some example embodiments, pericardial access device <NUM> may be configured so that pericardial needle <NUM> is rotatable. For example, needle <NUM> may be extended from proximal to internal distal face <NUM> into suction cavity <NUM> with one side (e.g., a flat side <NUM>) facing generally away from inclined distal face <NUM> (e.g., round side <NUM> facing generally towards inclined distal face <NUM>). Needle <NUM> may be rotated so that flat side <NUM> faces generally toward inclined distal face <NUM> (e.g., round side <NUM> faces generally away from inclined distal face <NUM>). In some example embodiments, a generally opposite approach may be used. For example, needle <NUM> may be extended with another side (e.g., round side <NUM>) facing generally away from inclined distal face <NUM> (e.g., flat side <NUM> facing generally towards inclined distal face <NUM>). Needle <NUM> may be rotated so that round side <NUM> faces generally inclined distal face <NUM> (e.g., flat side <NUM> faces generally away from inclined distal face <NUM>). In some example embodiments, rotation of needle <NUM> may facilitate puncturing pericardium <NUM> in a desired manner, may facilitate insertion of guide wire <NUM> in a desired direction, and/or reduce the risk of needle <NUM> extending into heart tissue (e.g., a ventricle).

Referring to <FIG>, in some example embodiments, pericardial access device <NUM> may include a generally proximally disposed suction port <NUM>, which may be fluidicly coupled to suction cavity <NUM> via one or more of first channel <NUM> and/or second channel <NUM>, or another longitudinal channel. For example, referring to <FIG>, in some example embodiments, tubular body <NUM> may include one or more additional longitudinal channels, such as third channel <NUM> and/or fourth channel <NUM>. One or more of third and fourth channels <NUM>, <NUM> may be utilized, for example, to couple suction port <NUM> to suction cavity <NUM>.

An example method of using pericardial access device <NUM> (<FIG>) is described with reference to <FIG>. <FIG> is a detailed side elevation view of distal end <NUM> of tubular body <NUM> showing tip <NUM> in the closed configuration approaching a pericardium <NUM>, <FIG> is a detailed side elevation view of distal end <NUM> of tubular body <NUM> in the open configuration approaching pericardium <NUM>, <FIG> is a detailed side elevation view of distal end <NUM> of tubular body <NUM> in contact with pericardium <NUM>, <FIG> is a detailed side elevation cutaway view of distal end <NUM> of tubular body <NUM> showing a portion of pericardium <NUM> drawn into suction cavity <NUM>, <FIG> is a detailed side elevation cutaway view of distal end <NUM> of tubular body <NUM> showing needle <NUM> puncturing pericardium <NUM>, <FIG> is a detailed side elevation cutaway view of distal end <NUM> of tubular body <NUM> showing extension of guide wire <NUM> into a pericardial space <NUM>, and <FIG> is a detailed side elevation view of distal end <NUM> of tubular body <NUM> showing the withdrawal of pericardial access device <NUM> leaving guide wire <NUM> in place.

Referring to <FIG>, pericardial access device <NUM> with tip <NUM> in the closed configuration may be directed towards a target tissue, such as pericardium <NUM>, to obtain access to pericardial space <NUM>. At least partially transparent, blunt-tipped dissecting point <NUM> of tip <NUM> may facilitate obtaining access to and/or visualizing an appropriate access location on pericardium <NUM>. Additionally, fluoroscopy, ultrasound, and/or other imaging technologies may be utilized to guide device <NUM> into the desired position proximate pericardium <NUM>. One or more components of pericardial access device <NUM> may be constructed of materials that are visible using such imaging technologies and/or may include markers that are visible using such imaging technologies.

Referring to <FIG>, tip <NUM> may be pivoted from the closed configuration to the open configuration. For example, tip <NUM> may be pressed laterally against pericardium <NUM> and/or another anatomical structure to pivot tip <NUM> to the open configuration.

Referring to <FIG>, distal face <NUM> may be placed against pericardium <NUM>. Distal face <NUM> may be configured to sealingly engage the outer surface of pericardium <NUM>.

Referring to <FIG>, suction may be applied to suction cavity <NUM>, such as via suction port <NUM> (<FIG>) and/or tubular body <NUM>, which may pull a portion of pericardium <NUM> proximally into suction cavity <NUM> and away from underlying tissues (e.g., the heart) so that the pericardium <NUM> is displaced from an epicardium <NUM> to form a working volume <NUM> not otherwise present.

Referring to <FIG>, pericardial needle <NUM> may be extended distally beyond internal distal face <NUM> and through pericardium <NUM>. In some example embodiments, needle <NUM> may be extended from proximal to internal distal face <NUM> into suction cavity <NUM> (e.g., through pericardium <NUM>) with a flat side <NUM> facing generally away from inclined distal face <NUM> (e.g., round side <NUM> facing generally towards inclined distal face <NUM>). In some example embodiments, other needle <NUM> orientations and/or rotations may be used.

Referring to <FIG>, needle <NUM> may be rotated so that flat side <NUM> faces generally toward inclined distal face <NUM> (e.g., round side <NUM> faces generally away from inclined distal face <NUM>) (see also <FIG>). In some example embodiments, other needle <NUM> orientations and/or rotations may be used. Guide wire <NUM> may be extended through needle <NUM> and the puncture in pericardium <NUM> into pericardial space <NUM>.

Referring to <FIG>, needle <NUM> may be at least partially withdrawn from pericardium <NUM> and/or device <NUM>. Suction within suction cavity <NUM> may be released, allowing pericardium <NUM> to relax and withdraw distally from within suction cavity <NUM>. Guide wire <NUM> may remain extending into pericardial space <NUM> through pericardium <NUM>. Pericardial access device <NUM> may be withdrawn away from pericardium <NUM>, leaving guide wire <NUM> in place. Tip <NUM> may be pivoted to a partially closed configuration during withdrawal. Guide wire <NUM> may be utilized as desired in connection with procedures requiring access to the epicardium, such as, without limitation, cardiac ablation to treat atrial fibrillation and/or occlusion of the left atrial appendage.

<FIG> is a flow diagram illustrating an example method <NUM> of obtaining pericardial access. The reference numerals are provided only in exemplary fashion and the method is not necessarily tied to the specific structures referenced. Operation <NUM> may include directing a pericardial access device <NUM> including tubular body <NUM> and a tip <NUM> towards a pericardium <NUM>. The tip <NUM> may be repositionable between a closed configuration and an open configuration and may include a blunt-tipped dissecting point <NUM>. Operation <NUM> may include visualizing the pericardium <NUM> using an endoscope <NUM> arranged to view through the dissecting point <NUM>, and the dissecting point <NUM> may be at least partially transparent. In the closed configuration, the tip <NUM> may substantially cover a distal end <NUM> of the tubular body. During this operation, the endoscope <NUM> may be positioned with the first channel <NUM> extending through the tubular body <NUM>. Operation <NUM> may include repositioning the tip <NUM> from the closed configuration to the open configuration. In the open configuration, a distal face <NUM> of the tubular body <NUM> may be exposed. This operation may include pressing the tip <NUM> laterally against an anatomical structure to reposition the tip <NUM> to the open configuration and/or pivoting the tip <NUM> about a tip pivot axis <NUM>. Operation <NUM> may include sealingly engaging the distal face <NUM> of the tubular body <NUM> against the pericardium <NUM>. Operation <NUM> may include drawing a portion of the pericardium <NUM> into a suction cavity <NUM> defined at least partially by the distal face <NUM> by applying suction to the suction cavity <NUM> so that the pericardium <NUM> is displaced from the epicardium <NUM> to form a working volume <NUM> not otherwise present. Operation <NUM> may include puncturing the pericardium <NUM> by extending a pericardial needle <NUM> into the suction cavity <NUM>. During this operation, the pericardial needle <NUM> may be positioned within second channel <NUM> extending through the tubular body <NUM>. This operation may include rotating the pericardial needle <NUM>. Operation <NUM> may include extending a guide wire <NUM> through the pericardial needle <NUM> into a pericardial space <NUM>. Operation <NUM> may include releasing suction on the suction cavity <NUM>. This operation may be preceded by withdrawing the pericardial needle <NUM>. Operation <NUM> may include withdrawing the pericardial access device <NUM> away from the pericardium <NUM> while leaving the guide wire <NUM> extending into the pericardial space <NUM>.

Claim 1:
A surgical device (<NUM>) for accessing a pericardial space of a patient, comprising:
an elongated, tubular body (<NUM>) including a proximal end (<NUM>) and a distal end (<NUM>), the tubular body including a longitudinal first channel (<NUM>) configured to accept an endoscope (<NUM>) therein; and
a repositionable tip (<NUM>) disposed at the distal end (<NUM>) of the tubular body (<NUM>), the tip including a substantially blunt, distally oriented dissection point (<NUM>) and a proximal repositionable connector, the proximal repositionable connector repositionably engaging the tubular body near the distal end of the tubular body so that the tip is repositionable between a closed configuration and an open configuration;
wherein, in the closed configuration, the tip (<NUM>) substantially covers the distal end (<NUM>) of the tubular body (<NUM>) and extends distally beyond the distal end of the tubular body; and
wherein, in the open configuration, the tip (<NUM>) is positioned at least partially beside the distal end (<NUM>) of the tubular body (<NUM>) so that a distal face (<NUM>) of the tubular body is exposed,
characterised by the repositionable tip (<NUM>) being at least partially transparent; and
the tubular body (<NUM>) including a longitudinal second channel (<NUM>) configured to accept a pericardial needle (<NUM>) therethrough.