Pericardiotomy Devices and Related Methods

Abstract

Pericardiotomy devices are disclosed. An example of a pericardiotomy device includes an elongate shaft and an end effector disposed distally on the shaft. The end effector includes a tip portion and a piercing element. The tip portion includes an opening configured to engage a target portion of the pericardium and is configured to separate the target portion of the pericardium from an exterior surface of the heart upon application of a vacuum to the tip portion. The piercing element is disposed within the tip portion such that upon application of a vacuum to the tip portion, the piercing element acts to create an opening in the target portion of the pericardium.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Non-provisional Patent Application No. 17 / 588,227, filed January 29, 2022, and U.S. Provisional Patent Application No. 63 / 294,455, filed December 29, 2021, both of which are incorporated by reference. [Background technology]

[0002] The present disclosure is directed to medical instruments and devices and associated methods, and in particular to surgical devices and associated methods for creating an opening in the pericardium.

[0003] The present disclosure contemplates that some internal anatomical structures may be at least partially covered by one or more layers of tissue. For example, in mammals, the heart is partially surrounded by a sac-like tissue called the pericardium.

[0004] Further, 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 gain access to such anatomical structures. For example, in connection with some cardiac procedures, it may be necessary to penetrate the pericardium to allow surgical instruments to directly access the heart. As used herein, a "pericardiotomy" may refer to a surgical procedure in which an opening is made through a patient's pericardium. A pericardiotomy may be performed to allow a surgeon to access a patient's heart, such as in connection with cardiac ablation to treat atrial fibrillation and / or occlusion of the left atrial appendage.

[0005] The present disclosure contemplates that, particularly in the context of minimally invasive procedures, surgeons may face challenges when performing a pericardial incision. For example, it is generally desirable to create an opening through the pericardium without substantially affecting (e.g., cutting or burning) the underlying epicardium (i.e., heart wall). In addition, when a pericardial incision is performed with the patient's heart beating (e.g., without cardiopulmonary bypass), movement of the heart and / or pericardium may increase the complexity of the procedure.

[0006] Although pericardiotomy has been performed using known devices and techniques, improvements in the structure and operation of pericardiotomy devices would be beneficial to users (e.g., surgeons) and patients. The present disclosure includes various improvements that may improve the structure, operation, and methods of use of pericardiotomy devices.

[0007] It is an aspect of the present disclosure to provide a pericardiotomy device configured to create an opening through the pericardium. The pericardiotomy device may include an elongate shaft and an end effector disposed distally on the shaft. The end effector may include a tip portion including an opening configured to engage a target portion of the pericardium. The tip portion may be configured to separate the target portion of the pericardium from an exterior surface of the heart upon application of a vacuum to the tip portion. The end effector may include at least one piercing element disposed within the tip portion such that the at least one piercing element may act to create an opening in the target portion of the pericardium upon application of a vacuum to the tip portion.

[0008] In detailed embodiments, the piercing element may be disposed at a fixed position within the tip portion. The opening may include a distal opening and / or the piercing element may be retracted proximally relative to the distal opening within the tip portion. The piercing element may include a generally triangular blade and / or the blade may be generally diametrically oriented within the tip portion and / or may include a distally oriented sharp point. The blade may include at least one obliquely oriented cutting edge. The pericardiotomy device may include externally visible indicia indicating the orientation of the blade's cutting edge.

[0009] In detailed embodiments, the piercing element may be movably disposed relative to the tip portion. The piercing element may be movably disposed distally relative to the tip portion. The piercing element may include a needle. The pericardiotomy device may include a handle disposed proximally on the shaft, and / or the handle may include a needle release actuator operable to release the needle from a retracted proximal position to a distal extended position. The handle may include a needle retraction actuator operable to move the needle from an extended position to a retracted position. The handle may include a needle depth actuator operable to adjust the longitudinal position of the needle's extended position. In some embodiments, the needle may include a hollow needle.

[0010] In detailed embodiments, the penetrating element may be rotatably and movably disposed relative to the tip portion. The penetrating element may include a needle. The pericardiotomy device may include a handle disposed proximally on the shaft and / or the handle may include a needle rotation actuator operable to rotate the needle from a retracted proximal position to a distally extended position. The end effector may include a needle manipulation mechanism that may include a needle mount rotatably disposed on the axle. The needle may be disposed on the needle mount. The pericardiotomy device may include a linkage operatively coupling the needle rotation actuator and the needle manipulation mechanism. In some embodiments, the needle may include a curved needle.

[0011] In detailed embodiments, the tip section may be formed in a bell shape such that a proximal portion of the tip section has an outer diameter approximately the same as the outer diameter of the shaft, and a distal end of the tip section has an outer diameter larger than the outer diameter of the shaft, hi some embodiments, the outer diameter of the distal end of the tip section may be approximately twice the outer diameter of the shaft.

[0012] In a detailed embodiment, the pericardiotomy device may include at least one vacuum connector fluidly coupled to the tip portion and configured to fluidly couple to a vacuum source.

[0013] It is an aspect of the present disclosure to provide a method of creating an opening through the pericardium, the method including the steps of applying a vacuum to an opening in a tip portion of an end effector of a pericardiotomy device while the end effector is proximate to the pericardium, the end effector including a penetrating element positioned proximate to the opening, increasing the distance between the target portion of the pericardium and the exterior surface of the heart by applying vacuum to the tip portion to result in a penetration distance, and / or penetrating the target portion of the pericardium to create an opening therethrough by contacting the target portion of the pericardium with the penetrating element while the penetration distance is maintained.

[0014] In a detailed embodiment, the piercing element may be disposed in a fixed position relative to the tip portion. Contacting the target portion of the pericardium with the piercing element may include retracting the target portion of the pericardium proximally to the tip portion into contact with the piercing element. The method may include enlarging the opening after contacting the target portion of the pericardium with the piercing element. Enlarging the opening may include cutting the pericardium laterally with the piercing element by moving an end effector of the pericardiotomy device laterally relative to the pericardium. The enlarging operation may be performed while a vacuum is maintained at the tip portion.

[0015] In a detailed embodiment, the piercing element may be movably disposed distally relative to the tip portion. Contacting the target portion of the pericardium with the piercing element may include moving the piercing element distally relative to the tip portion to pierce the target portion of the pericardium. Moving the piercing element distally relative to the tip portion to pierce the target portion of the pericardium may include releasing the piercing element from a proximal retracted position to a distal extended position. The method may include moving the piercing element proximally from the extended position to a retracted position and holding the piercing element in the retracted position prior to moving the piercing element distally relative to the tip portion. Moving the piercing element distally relative to the tip portion may include manipulating a needle release actuator. The method may include manipulating a needle depth actuator to adjust a longitudinal position of the piercing element in the extended position prior to moving the piercing element distally relative to the tip portion.

[0016] In a detailed embodiment, the piercing element may be rotatably and movably disposed relative to the tip portion. Contacting the target portion of the pericardium with the piercing element may include rotating the piercing element relative to the tip portion to pierce the target portion of the pericardium. Rotating the piercing element relative to the tip portion to pierce the target portion of the pericardium may include rotating the piercing element from a proximal retracted position to a distal extended position. The piercing element may include a curved needle. Rotating the piercing element relative to the tip portion to pierce the target portion of the pericardium may include rotating the curved needle about a diametrically oriented axle. Rotating the piercing element relative to the tip portion to pierce the target portion of the pericardium may include manipulating a needle rotation actuator disposed on a handle portion of the pericardiotomy device.

[0017] In detailed embodiments, rotating the piercing element from a proximal retracted position to a distal extended position may include rotationally rotating the piercing element from the proximal retracted position to a partially extended position between the retracted position and the extended position to engage the piercing element with a target portion of the pericardium, verifying engagement of the piercing element with the target portion of the pericardium, and / or rotating the piercing element from the partially extended position to the extended position to cut the target portion of the pericardium to create an opening therethrough. In detailed embodiments, the method may include moving the pericardiotomy device proximally to further increase the distance between the target portion of the pericardium and the exterior surface of the heart prior to rotating the piercing element from the partially extended position to the extended position.

[0018] It is an aspect of the present disclosure to provide a method of creating an opening through the pericardium, comprising the steps of engaging an opening of a tip portion of an end effector of a pericardiotomy device with the pericardium, the end effector having a tip portion and at least one penetrating element disposed proximate to the tip portion, separating a target portion of the pericardium from the heart by applying a vacuum to the tip portion, and / or creating an opening through the target portion of the pericardium by penetrating the target portion of the pericardium with the penetrating element.

[0019] In detailed embodiments, the piercing element may include a fixed piercing element disposed in a fixed position relative to the tip portion. Penetrating the target portion of the pericardium with the piercing element may include using a vacuum to draw the target portion of the pericardium into contact with the fixed piercing element by moving the end effector laterally over the pericardium. The method may include enlarging the opening by moving the end effector laterally over the pericardium.

[0020] In a detailed embodiment, the penetrating element may include a distally movable penetrating element. Penetrating the target portion of the pericardium with the penetrating element may include releasing the distally movable penetrating element from a proximal retracted position to a distal extended position.

[0021] In a detailed embodiment, the penetrating element may include a rotatable penetrating element. Penetrating the target portion of the pericardium with the penetrating element may include rotating the penetrating element from a proximal, retracted position to a distal, extended position.

[0022] It is an aspect of the present disclosure to provide a method of engaging tissue that includes repositioning an end effector proximate to a tissue surface, longitudinally rotating a penetrator from a retracted position not in contact with the tissue surface to an engaged position in contact with and extending into the tissue surface, and / or repositioning the end effector in a direction away from the tissue surface to tension the tissue.

[0023] In detailed embodiments, the method may further include continuing to rotate the penetrator longitudinally from the engaged position to a piercing position where the penetrator pierces the tissue. The method may further include applying a vacuum to the end effector as the end effector is proximate the tissue surface. Repositioning the end effector proximate the tissue surface may include positioning the end effector to form a seal between the end effector and the tissue surface.

[0024] It is an aspect of the present disclosure to provide any method, operation, process, system, device, and / or apparatus in connection with any of the preceding aspects or described elsewhere herein.

[0025] It is an aspect of the present disclosure to provide any combination of any one or more elements of any of the preceding aspects or described elsewhere herein.

[0026] Example embodiments are described in conjunction with the accompanying drawings, all in accordance with at least some aspects of the present disclosure. [Brief description of the drawings]

[0027] [Figure 1] FIG. 1 is a perspective view of an example of a pericardiotomy device including a fixed blade. [Diagram 2] FIG. 2 is a detailed perspective view of a proximal portion of the pericardiotomy device of FIG. 1. [Diagram 3] FIG. 2 is a detailed perspective view of a distal portion of the pericardiotomy device of FIG. 1. [Figure 4] FIG. 2 is a detailed perspective view of a distal portion of the pericardiotomy device of FIG. 1. [Diagram 5] 2 is a simplified cross-sectional view of a distal portion of the pericardiotomy device of FIG. 1. [Figure 6] 13 is a perspective view of an alternative example of a pericardiotomy device including a distally movable needle. [Figure 7] FIG. 7 is a detailed perspective view of a proximal portion of the pericardiotomy device of FIG. [Figure 8] 7 is a detailed perspective view of a distal portion of the pericardiotomy device of FIG. 6 with the needle in the extended position. FIG. [Figure 9] FIG. 7 is a detailed perspective view of a distal portion of the pericardiotomy device of FIG. 6 with the needle in a retracted position. [Figure 10] FIG. 7 is a detailed side perspective view of a distal portion of the pericardiotomy device of FIG. 6 with the needle in the extended position. [Figure 11] 7 is a simplified cross-sectional view of a distal portion of the pericardiotomy device of FIG. 6. [Figure 12] FIG. 7 is a simplified perspective view of a needle mechanism of the pericardiotomy device of FIG. [Figure 13] 13 is a perspective view of an alternative example of a pericardiotomy device including a rotatable needle. [Figure 14] FIG. 14 is a detailed perspective view of a distal portion of the pericardiotomy device of FIG. 13 with the needle in a retracted position. [Figure 15] FIG. 14 is a detailed perspective view of a distal portion of the pericardiotomy device of FIG. 13 with the needle in the extended position. [Figure 16] FIG. 14 is a detailed perspective view of a distal portion of the pericardiotomy device of FIG. 13. [Figure 17] 14 is a simplified cross-sectional view of a distal portion of the pericardiotomy device of FIG. 13. [Figure 18] FIG. 14 is a simplified perspective view of a needle mechanism of the pericardiotomy device of FIG. [Figure 19] FIG. 14 is a cross-sectional view of the handle of the pericardiotomy device of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Examples of embodiments according to the present disclosure are described and illustrated below, including devices, methods, and techniques related to medical and surgical procedures, such as for creating an opening through the pericardium. Of course, it will be apparent to those skilled in the art that the embodiments discussed below are examples and may be reconfigured without departing from the scope and spirit of the present disclosure. It should also be understood that variations of the example embodiments contemplated by those skilled in the art naturally also comprise part of the present disclosure. However, for clarity and precision, the example embodiments discussed below may include any steps, methods, and features that a person skilled in the art should recognize as not essential to fall within the scope of the present disclosure. Unless otherwise expressly stated, any feature or function described in connection with any example embodiment may be utilized with a feature or function described in connection with any other example embodiment. Repeated descriptions of similar features and functions are omitted for brevity.

[0029] FIG. 1 is a perspective view of an example pericardiotomy device 100 including a fixed blade, FIG. 2 is a detailed perspective view of a proximal portion of the pericardiotomy device 100 of FIG. 1, FIG. 3 is a detailed perspective view of a distal portion of the pericardiotomy device 100 of FIG. 1, FIG. 4 is a detailed perspective view of a distal portion of the pericardiotomy device 100 of FIG. 1, and FIG. 5 is a simplified cross-sectional view of a distal portion of the pericardiotomy device 100 of FIG. 1, all according to at least some embodiments of the present disclosure. In general, the pericardiotomy device 100 may be similar in structure and operation to other pericardiotomy devices described herein, and a repeated description of similar elements will be omitted for brevity. With reference to FIGS. 1 and 5, the pericardiotomy device 100 may be used in connection with a pericardiotomy procedure that includes the creation of an opening through a patient's pericardium 10, such as to gain access to the patient's heart 12. With reference to FIG. 1, a pericardiotomy device 100 may be operatively coupled to a vacuum source 14 .

[0030] For clarity, the following description refers to a distal direction 16 and a proximal direction 18. The proximal direction 18 may be generally opposite the distal direction 16. As used herein, "distal" may refer to a direction generally away from an operator (e.g., a surgeon) of a system or device, such as a direction toward the most distal end of the device that is inserted into the patient's body. As used herein, "proximal" may refer to a direction generally toward an operator (e.g., a surgeon) of a system or device, such as a direction away from the most distal end of the device that is inserted into the patient's body. However, it will be understood that the example directions referenced herein are for purposes of illustration and clarity only and should not be considered limiting.

[0031] 1, 3, 4, and 5, in the illustrated embodiment, the pericardiotomy device 100 includes an elongated, generally tubular shaft 102 and an end effector 104 disposed generally distally on the shaft 102. In some example embodiments, the shaft 102 may have an outer diameter 103 of about 12 mm. The shaft 102 may be configured to be substantially rigid, elastically deformable, and / or plastically deformable (when subjected to forces consistent with normal intended use of the device 100), and such characteristics may vary over the proximal-distal length of the shaft 102. In the illustrated embodiment, the shaft 102 is in the form of a tubular right cylinder defining an interior channel 132 extending longitudinally therethrough.

[0032] 3-5, in the illustrated embodiment, the end effector 104 includes a tip portion 110 and a piercing element, such as one or more blades 106, configured to create an opening through the pericardium 10. In the illustrated embodiment, the blades 106 are fixed relative to the tip portion 110. That is, the blades 106 are disposed in a fixed position relative to the tip portion 110, such as generally within the tip portion 110, and the blades 106 do not move relative to the tip portion 110 during use of the pericardiotomy device 100. The blades 106 may be disposed at least partially within the tip portion 110. In the illustrated embodiment, the blades 106 may be generally oriented diametrically. With reference to FIG. 3, in some embodiments, the blades 106 may be generally triangular in shape with a distally directed sharp point. In some embodiments, the blades 106 may include one or more cutting edges 106A, which may be generally oriented obliquely.

[0033] 1, 3, 4 and 5, the tip portion 110 may include an opening, such as a distal opening 112, configured to engage the pericardium 10 and allow the pericardium 10 to contact the blade 106. In some example embodiments, the distal opening 112 may be generally circular. In some example embodiments, the tip portion 110 may be constructed from a substantially transparent material (e.g., a substantially optically transparent material), which may facilitate visibility through the tip portion 110, such as visualization of the blade 106. In other embodiments, at least a portion of the tip portion 110 may be constructed at least in part from a translucent and / or opaque material, such as, but not limited to, a radiopaque material.

[0034] 1 and 2, the pericardiotomy device 100 may include at least one vacuum connector 122 that may be used to fluidly connect the pericardiotomy device 100 to a vacuum source 14. In the illustrated embodiment, the vacuum connector 122 is disposed generally proximally on the shaft 102, and the vacuum connector 122 is configured to mate with a vacuum line 124 that includes one or more lumens. In other embodiments, the vacuum line 124 may extend from the pericardiotomy device 100, and the vacuum connector 122 may be disposed on an end of the line 124 that is attached to the vacuum source 14. Examples of vacuum sources 14 include a vacuum pump and a connection to a central vacuum system, such as may be available at a hospital or surgical facility.

[0035] 1 and 5, vacuum from vacuum source 14 may be selectively applied to tip portion 110, such as through an internal channel 132 of shaft 102. Channel 132 may be configured as a vacuum conduit fluidly interposed between tip portion 110 and vacuum connector 122. Application of vacuum to tip portion 110 (e.g., through vacuum connector 122 and internal channel 132) may act to draw target portion 10A of pericardium 10 into tip portion 110, as indicated by arrow 134. In this embodiment, drawing of target portion 10A of pericardium 10 into tip portion 110 by application of vacuum brings pericardium 10 into contact with blade 106. In the illustrated embodiment, blade 106 is retracted proximally a distance indicated by arrow 134 within tip portion 110. In other embodiments, the blade 106 may be positioned at other proximal-distal locations within the tip portion 110, such as substantially flush with the distal end of the tip portion 110 (e.g., zero distance retraction). In the illustrated embodiment, the blade 106 is retracted proximally within the tip portion 110, so that the application of a vacuum to draw the pericardium 10 proximally into the tip portion 110 also creates and / or increases the distance between the surface of the heart 12 and where the blade 106 is used to cut through the pericardium 10. This may reduce the possibility of damage to the heart 12 (e.g., due to contact with the blade 106).

[0036] 5, in the illustrated embodiment, the tip portion 110 may be formed in a narrow bell shape. For example, the proximal portion of the tip portion 110 may have an outer diameter approximately the same as the outer diameter 103 of the shaft 102 (e.g., about 12 mm). The distal end 111 of the tip portion 110 may have an outer diameter 111A that is larger than the outer diameter 103 of the shaft 102 (e.g., about 13 mm). In some embodiments, the radially outer surface of the tip portion 110 may be continuously curved, such as generally concavely curved, between the proximal portion of the tip portion 110 near the shaft 102 and the distal end 111 of the tip portion 110.

[0037] 4, some example embodiments may include externally visible indicia 160 that may be configured to indicate to a user the orientation of the pericardiotomy device 100, such as the orientation of the blade 106. In the illustrated embodiment, the indicia 160 indicates a radial direction generally aligned with the beveled cutting edge 106A of the blade 106.

[0038] 1 and 5, in use, the pericardiotomy device 100 may be positioned such that the distal end 111 of the tip portion 110 is in contact with the pericardium 10. A vacuum may be applied to the tip portion 110, causing the target portion 10A of the pericardium to be drawn proximally to the tip portion 110. The target portion 10A of the pericardium may be drawn proximally into contact with the blade 106 (e.g., a distally facing point), causing the target portion 10A of the pericardium to be cut through to create an opening through the pericardium 10. If it is desired to enlarge the opening through the pericardium 10, the end effector 104 of the pericardiotomy device 100 may be moved laterally relative to the pericardium, such as while the vacuum is maintained, causing the blade 106 to cut the pericardium 10 laterally. For example, pericardiotomy device 100 can be moved generally in the direction indicated by indicia 160 to cut through pericardium 10 using cutting edge 106A of blade 106 to create an elongated opening. The vacuum can be discontinued and pericardiotomy device 100 can be moved away from the target portion 10A of the pericardium.

[0039] FIG. 6 is a perspective view of an alternative example pericardiotomy device 200 including a distally movable needle; FIG. 7 is a detailed perspective view of a proximal portion of the pericardiotomy device 200 of FIG. 6; FIG. 8 is a detailed perspective view of a distal portion of the pericardiotomy device 200 of FIG. 6 with the needle in an extended position; FIG. 9 is a detailed perspective view of a distal portion of the pericardiotomy device 200 of FIG. 6 with the needle in a retracted position; FIG. 10 is a detailed side perspective view of the distal portion of the pericardiotomy device 200 of FIG. 6 with the needle in an extended position; FIG. 11 is a simplified cross-sectional view of the distal portion of the pericardiotomy device 200 of FIG. 6; and FIG. 12 is a simplified perspective view of a needle mechanism of the pericardiotomy device 200 of FIG. 6, all according to at least some embodiments of the present disclosure. In general, the pericardiotomy device 200 may be similar in structure and operation to other pericardiotomy devices described herein, and a repeated description of similar elements will be omitted for brevity. With reference to Fig. 11, the pericardiotomy device 200 may be used in connection with a pericardiotomy procedure that includes creating an opening through a patient's pericardium 10, such as to gain access to the patient's heart 12. With reference to Fig. 6, the pericardiotomy device 200 may be operatively coupled to a vacuum source 14.

[0040] 6-11, in the illustrated embodiment, the pericardiotomy device 200 includes an elongated, generally tubular shaft 202, an end effector 204 disposed generally distally on the shaft 202, and a handle 250 disposed generally proximally on the shaft 202. In some example embodiments, the shaft 202 may have an outer diameter 203 of about 5.0 mm. The shaft 202 may be configured to be substantially rigid, elastically deformable, and / or plastically deformable (when subjected to forces consistent with normal intended use of the device 200), and such characteristics may vary over the proximal-distal length of the shaft 202. In the illustrated embodiment, the shaft 202 is in the form of a tubular right cylinder defining an interior channel 232 extending longitudinally therethrough.

[0041] 8 and 11, in the illustrated embodiment, the end effector 204 includes a tip portion 210 and a piercing element, such as one or more needles 206, configured to create an opening through the pericardium 10. The needles 206 may be movably positioned, including but not limited to, rotationally and / or longitudinally (proximal-distal), to selectively extend at least partially within the tip portion 210. With reference to FIGS. 8, 10, and 12, in some embodiments, the needles 206 may be hollow and / or have a beveled sharp point.

[0042] 6 and 8-11, the tip portion 210 may include an opening, such as a distal opening 212, configured to engage the pericardium 10 and allow the needle 206 to contact the pericardium 10. In some example embodiments, the distal opening 212 may be generally circular. In some example embodiments, the tip portion 210 may be constructed from a substantially transparent material (e.g., a substantially optically transparent material), which may facilitate visibility through the tip portion 210, such as visualization of the needle 206. In other embodiments, at least a portion of the tip portion 210 may be constructed at least in part from a translucent and / or opaque material, such as, but not limited to, a radiopaque material.

[0043] 6 and 7, the pericardiotomy device 200 may include at least one vacuum connector 222 that may be used to fluidly connect the pericardiotomy device 200 to a vacuum source 14. In the illustrated embodiment, the vacuum connector 222 is disposed generally proximally on the shaft 202, and the vacuum connector 222 is configured to mate with a vacuum line 124 that includes one or more lumens. In other embodiments, the vacuum line 124 may extend from the pericardiotomy device 200, and the vacuum connector 222 may be disposed on an end of the line 124 that is attached to the vacuum source 14. Examples of vacuum sources 14 include a vacuum pump and a connection to a central vacuum system, such as may be available at a hospital or surgical facility.

[0044] 6 and 11, vacuum from vacuum source 14 may be selectively applied to tip portion 210, such as through internal channel 232 of shaft 202. Channel 232 may be configured as a vacuum conduit fluidly interposed between tip portion 210 and vacuum connector 222. Application of vacuum to tip 210 (e.g., through vacuum connector 222 and internal channel 232) may act to draw target portion 10A of pericardium 10 into tip portion 210, as indicated by arrow 234. In this embodiment, drawing of target portion 10A of pericardium 10 into tip portion 210 by application of vacuum pulls pericardium 10 into the operative range of needle 206. In the illustrated embodiment, at its most distal extended position, needle 206 is retracted proximally a distance indicated by arrow 234 in tip portion 210. In other embodiments, needle 206 may be positioned at other proximal-distal locations within tip portion 210, such as substantially flush with the distal end of tip portion 210 (e.g., zero distance retraction). In the illustrated embodiment, because needle 206 is proximally retracted within tip portion 210 even in its most distal extended position, drawing pericardium 10 proximally into tip portion 210 by application of vacuum also creates and / or increases the distance between the surface of heart 12 and the location where needle 206 is used to puncture pericardium 10. This may reduce the possibility of damage to heart 12 (e.g., due to contact with needle 206).

[0045] 11, in the illustrated embodiment, the tip portion 210 may be formed in a wide bell shape. For example, the proximal portion of the tip portion 210 may have an outer diameter approximately the same as the outer diameter 203 of the shaft 202 (e.g., about 5.0 mm). The distal end 211 of the tip portion 210 may have an outer diameter 211A that is substantially larger than the outer diameter 203 of the shaft 202. In some embodiments, the radially outer surface of the tip portion 210 may be continuously curved, such as generally concavely curved, between the proximal portion of the tip portion 210 near the shaft 202 and the distal end 211 of the tip portion 210. For example, the maximum outer diameter 211A of the tip portion 210 (e.g., proximate the distal end 211) may be approximately 10.5 mm. Thus, in some embodiments, the maximum outer diameter 211A of the tip portion 210 may be approximately twice the outer diameter 203 of the shaft 202.

[0046] 6 and 7, in the illustrated embodiment, the handle 250 includes a grip portion 252 that may be configured to be grasped by a user (e.g., a surgeon). The handle 250 includes a proximally disposed needle retraction actuator 254 that may be manipulated (e.g., pulled generally proximally) to move the needle 206 from the extended position (FIGS. 10 and 11) to the retracted position 206A (FIG. 9). The handle 250 includes a needle release actuator 256 that may be manipulated to release the needle from the retracted position 206A (FIG. 11) to the extended position (FIGS. 10 and 11). In the illustrated embodiment, the needle release actuator 256 includes a button disposed proximate to the grip portion 252. The handle 250 includes a needle depth actuator 258 that may be manipulated to adjust the longitudinal (e.g., proximal-distal) position of the extended position of the needle 206. In the illustrated embodiment, the needle depth actuator 258 includes a generally cylindrical rotatable element disposed concentrically with and / or distally relative to the grip portion 252. The handle 250 may include needle depth indicia 260 provided to indicate various predetermined positions of the needle depth actuator 258. The actuators 254, 256, 258 are operatively coupled to a distal portion of the pericardiotomy device 200 (e.g., end effector 204) such as by one or more suitable mechanical linkages 262 ( FIG. 11 ).

[0047] In some example embodiments, the pericardiotomy device 200 may include a needle manipulation mechanism, such as in the handle 250 and / or in the end effector 204, that may be configured to hold the needle 206 in a retracted position and / or extend the needle 206 upon operation of the needle release actuator 256. Generally, the needle 206 may be placed in the retracted position by operating the needle retraction actuator 254. In some example embodiments, retracting the needle 206 may elastically deform a spring that forms part of the needle manipulation mechanism. The needle 206 may remain in the retracted position (with the spring elastically deformed) until the needle release actuator 256 is operated. Once the needle release actuator 256 is operated, the needle 206 may be released and the spring may drive the needle 206 to the extended position.

[0048] In use, the pericardiotomy device 200 may be prepared for use by manipulating the needle retraction actuator 254 to move the needle 206 from the extended position to the retracted position 206A. The needle depth actuator 258 may be manipulated to select a desired longitudinal position of the extended position of the needle 206. The pericardiotomy device 200 may be positioned such that the distal end 211 of the tip portion 210 contacts the pericardium 10. A vacuum may be applied to the tip portion 210, thereby drawing the target portion 10A of the pericardium proximally to the tip portion 210. The needle release actuator 256 may be manipulated to release the needle from the retracted position 206A to the extended position, thereby causing the needle to penetrate the target portion 10A of the pericardium to create an opening through the pericardium 10. The vacuum may be discontinued and the pericardiotomy device 200 may be moved away from the target portion 10A of the pericardium.

[0049] FIG. 13 is a perspective view of an alternative example pericardiotomy device 300 including a rotatable needle, FIG. 14 is a detailed perspective view of the distal portion of the pericardiotomy device 300 of FIG. 13 with the needle 306 in a retracted position, FIG. 15 is a detailed perspective view of the distal portion of the pericardiotomy device 300 of FIG. 13 with the needle 306 in an extended position, FIG. 16 is a detailed perspective view of the distal portion of the pericardiotomy device 300 of FIG. 13, FIG. 17 is a simplified cross-sectional view of the distal portion of the pericardiotomy device 300 of FIG. 13, FIG. 18 is a simplified perspective view of the needle mechanism of the pericardiotomy device 300 of FIG. 13, and FIG. 19 is a cross-sectional view of the handle of the pericardiotomy device 300 of FIG. 13, all according to at least some aspects of the present disclosure. In general, the pericardiotomy device 300 may be similar in structure and operation to other pericardiotomy devices described herein, and a repeated description of similar elements will be omitted for brevity. With reference to Fig. 17, the pericardiotomy device 300 may be used in connection with a pericardiotomy procedure that involves creating an opening through a patient's pericardium 10, such as to gain access to the patient's heart 12. With reference to Fig. 13, the pericardiotomy device 300 may be operatively coupled to a vacuum source 14.

[0050] 13-17, in the illustrated embodiment, the pericardiotomy device 300 includes an elongated, generally tubular shaft 302, an end effector 304 disposed generally distally on the shaft 302, and a handle 350 disposed generally proximally on the shaft 302. In some example embodiments, the shaft 302 may have an outer diameter 303 of about 10.0 mm. The shaft 302 may be configured to be substantially rigid, elastically deformable, and / or plastically deformable (when subjected to forces consistent with normal intended use of the device 300), and such characteristics may vary over the proximal-distal length of the shaft 302. In the illustrated embodiment, the shaft 302 is in the form of a tubular right cylinder defining an interior channel 332 extending longitudinally therethrough.

[0051] 14, 15, and 17, in the illustrated embodiment, the end effector 304 includes a tip portion 310 and a piercing element, such as one or more needles 306, configured to create an opening through the pericardium 10. The needles 306 may be longitudinally and / or radially movably disposed to permit selective longitudinal rotation at least partially within the tip portion 310. In some embodiments, the needles 306 may be curved and / or have an angled sharp point. In alternative embodiments, the needles 306 may be movable and / or repositionable in any direction and / or about any axis relative to the tip portion 310. For example, the needles 306 may be rotatable about a longitudinally oriented axis.

[0052] The tip portion 310 may include an opening, such as a distal opening 312, configured to engage the pericardium 10 and allow the needle 306 to contact the pericardium 10. In some example embodiments, the distal opening 312 may be generally circular. In some example embodiments, the tip portion 310 may be constructed from a substantially transparent material (e.g., a substantially optically transparent material), which may facilitate viewability through the tip portion 310, such as visualization of the needle 306. In other embodiments, at least a portion of the tip portion 310 may be constructed at least in part from a translucent and / or opaque material, such as, but not limited to, a radiopaque material.

[0053] 13, the pericardiotomy device 300 may include at least one vacuum connector 322 that may be used to fluidly connect the pericardiotomy device 300 to a vacuum source 14. In the illustrated embodiment, the vacuum connector 322 is disposed generally proximally on the shaft 302, and the vacuum connector 322 is configured to mate with a vacuum line 124 that includes one or more lumens. In other embodiments, the vacuum line 124 may extend from the pericardiotomy device 300, and the vacuum connector 322 may be disposed on an end of the line 124 that is attached to the vacuum source 14. Examples of vacuum sources 14 include a vacuum pump and a connection to a central vacuum system, such as may be available at a hospital or surgical facility.

[0054] 13 and 17, vacuum from vacuum source 14 may be selectively applied to tip portion 310, such as through an internal channel 332 of shaft 302. Channel 332 may be configured as a vacuum conduit fluidly interposed between tip portion 310 and vacuum connector 322. Application of vacuum to tip 310 (e.g., via vacuum connector 322 and internal channel 332) may act to draw target portion 10A of pericardium 10 into tip portion 310, as indicated by arrow 334. In this embodiment, drawing of target portion 10A of pericardium 10 into tip portion 310 by application of vacuum pulls pericardium 10 into the operating range of needle 306. In the illustrated embodiment, at its most distal extended position, needle 306 is retracted proximally a distance indicated by arrow 334 in tip portion 310. In other embodiments, needle 306 may be positioned at other proximal-distal locations within tip portion 310, such as substantially flush with the distal end of tip portion 310 (e.g., zero distance retraction). In the illustrated embodiment, because needle 306 is proximally retracted within tip portion 310 even in its most distal extended position, drawing pericardium 10 proximally into tip portion 310 by application of vacuum also creates and / or increases the distance between the surface of heart 12 and the location where needle 306 is used to puncture pericardium 10. This may reduce the possibility of damage to heart 12 (e.g., due to contact with needle 306).

[0055] 17, in the illustrated embodiment, the tip portion 310 may be formed in a relatively narrow bell shape. For example, the proximal portion of the tip portion 310 may have an outer diameter approximately the same as the outer diameter 303 of the shaft 302 (e.g., about 10.0 mm). The distal end 311 of the tip portion 310 may have an outer diameter 311A ​​that is greater than the outer diameter 303 of the shaft 302. In some embodiments, the radially outer surface of the tip portion 310 may be continuously curved, such as generally concavely curved, between the proximal portion of the tip portion 310 near the shaft 302 and the distal end 311 of the tip portion 310. For example, the maximum outer diameter 311A ​​of the tip portion 310 (e.g., proximate the distal end 311) may be about 11.5 mm.

[0056] 13, in the illustrated embodiment, the handle 350 includes a grip portion 352 that may be configured to be grasped by a user (e.g., a surgeon). The handle 350 includes a proximally disposed needle rotation actuator 354 that may be manipulated (e.g., pulled generally proximally) to longitudinally rotate the needle 306 from a retracted position (FIG. 14) to an extended position (FIG. 15). The actuator 354 is operatively coupled to a distal portion of the pericardiotomy device 300 (e.g., end effector 304), such as by one or more suitable mechanical linkages 362 (FIG. 17).

[0057] 13-15, and 17-19, in some example embodiments, the pericardiotomy device 300 may include a needle manipulation mechanism 364, such as in the end effector 304, that may be configured to longitudinally extend / retract and / or rotate the needle 306 upon manipulation of a needle rotation actuator 354. Generally, the needle 306 may be disposed on a mount 366, which may be rotatably disposed on a diametrically oriented axle 368. Manipulation of the needle rotation actuator 354 on the handle 350 may act to rotate the mount 366 and the needle 306 about the axle 368.

[0058] In the illustrated embodiment, the needle 306 may be in a retracted position when the needle rotation actuator 354 is in the extended position 370. Gripping the needle rotation actuator 354 in a depressed position 372 toward the grip portion 352 may act to rotate the mount 366 and needle 306 to the extended position. For example, in the illustrated embodiment, gripping the needle rotation actuator 354 toward the grip portion 352 acts to move the actuator arm 356 generally downward as shown in FIG. 19. Moving the actuator arm 356 downward (as indicated by the arrow in FIG. 19) pulls the cable 358, which comprises a portion of the linkage 362, generally proximally, thereby causing rotation of the mount 366 and needle 306 to the extended position (see FIG. 18). Releasing the needle rotation actuator 354 so that it may move away from the grip portion 352 of the handle 350 allows distal movement of the cable 358. A tension spring 360 is coupled to a second cable 374, which comprises a portion of the linkage 362. The second cable 374 is operatively coupled to the rotatable mount 366 such that rotation from the retracted position to the extended position moves the cable 374 distally, thereby extending the spring 360. When the needle rotation actuator 354 is released, the spring 360 pulls the second cable 374 proximally, rotating the mount 366 and needle 306 to the retracted position and pulls the cable 358 distally, moving the actuator arm 356 and needle rotation actuator 354 to the retracted position. Generally, in the extended position, the needle 306 may extend distally further than when the needle is in the retracted position.

[0059] In use, the pericardiotomy device 300 can be positioned so that the distal end 311 of the tip portion 310 is in contact with the pericardium 10. A vacuum can be applied to the tip portion 310, thereby drawing the target portion of the pericardium 10A proximally to the tip portion 310. The needle rotation actuator 354 can be operated to longitudinally rotate the mount 366 and needle 306 to an extended position, thereby piercing the target portion of the pericardium 10A and creating an opening through the pericardium 10. The vacuum can be discontinued and the pericardiotomy device 300 can be moved away from the target portion of the pericardium 10A.

[0060] Some example embodiments may be configured for multiple stages of longitudinal rotation of the needle 306. For example, after applying a vacuum to the tip portion 310 and drawing the target portion 10A of the pericardium proximally to the tip portion 310, the needle 306 may be rotated from the retracted position to a partially extended position (e.g., rotationally between the retracted and fully extended positions). In the partially extended position, the needle 306 may engage and / or hold (e.g., puncture) the pericardium 10 without cutting completely through the pericardium 10. Thus, with the needle 306 in the partially extended position, the user may see where the pericardium is engaged and / or pull the pericardiotomy device 300 proximally to further tension the pericardium 10 away from the heart 12. If the positioning and / or engagement of the pericardium 10 is not satisfactory, the needle 306 may be returned to the retracted position, thereby releasing the pericardium 10. When the positioning and / or engagement of the pericardium 10 is satisfactory, the needle 306 may be rotated from a partially extended position to a fully extended position, thereby cutting the pericardium 10 to create an opening through the pericardium 10. Similarly, in some embodiments, the movement and / or rotation of the needle 306 may be used to enlarge the opening, such as by cutting tissue to create an elongated and / or generally circular opening.

[0061] An example method of creating an opening through the pericardium 10 according to at least some aspects of the present disclosure may include one or more of the following operations, in any combination: The method of creating an opening through the pericardium 10 may include applying a vacuum to an opening 112, 212, 312 in a tip portion 110, 210, 310 of an end effector 104, 204, 304 of a pericardiotomy device 100, 200, 300 while the end effector 104, 204, 304 is proximate to the pericardium 10 to draw the pericardium 10 to the opening 112, 212, 312. The end effector 104, 204, 304 may include a piercing element 106, 206, 306 disposed proximate to the opening 112, 212, 312. By applying a vacuum to tip portion 110, 210, 310, the distance 134, 234, 334 between the target portion 10A of the pericardium 10 and the exterior surface of the heart 12 may be increased to provide a penetration spacing. By contacting the target portion 10A of the pericardium 10 with the piercing element 106, 206, 306 while the penetration spacing is maintained, the target portion 10A of the pericardium 10 may be pierced to create an opening therethrough.

[0062] In some embodiments, the piercing element 106 may be positioned at a fixed position relative to the tip portion 110. Bringing the target portion 10A of the pericardium 10 into contact with the piercing element 106 may include retracting the target portion 10A of the pericardium 10 proximally to the tip portion 110 to contact the piercing element 106. After contacting the target portion 10A of the pericardium 10 with the piercing element 106, the opening may be enlarged. Enlarging the opening may include cutting the pericardium 10 laterally with the piercing element 106 by moving the end effector 104 of the pericardiotomy device 100 laterally relative to the pericardium 10. The enlarging operation may be performed while a vacuum is maintained at the tip portion 110.

[0063] In some embodiments, the piercing element 206 may be repositionable longitudinally and / or radially relative to the tip portion 210. Contacting the target portion 10A of the pericardium 10 with the piercing element 206 may include moving the piercing element 206 distally relative to the tip portion 210 to penetrate the target portion 10A of the pericardium 10. Moving the piercing element 206 distally relative to the tip portion 210 to penetrate the target portion 10A of the pericardium 10 may include releasing the piercing element 206 from a proximal retracted position to a distal extended position. Prior to moving the piercing element 206 distally relative to the tip portion 210, the piercing element 206 may be moved proximally from the extended position to a retracted position, and the piercing element 206 may be held in the retracted position. Moving the piercing element 206 distally relative to the tip portion 210 may include operating a needle release actuator 256. Prior to moving the piercing element 206 distally relative to the tip portion 210, the needle depth actuator 258 may be manipulated to adjust the longitudinal position of the piercing element 206 in the extended position.

[0064] In some embodiments, the piercing element 306 is rotatable longitudinally relative to the tip portion 310. Contacting the target portion 10A of the pericardium 10 with the piercing element 306 may include rotating the piercing element 306 longitudinally relative to the tip portion 310 to pierce the target portion 10A of the pericardium 10. Rotating the piercing element 306 relative to the tip portion 310 to pierce the target portion 10A of the pericardium 10 may include rotating the piercing element 306 longitudinally from a proximal retracted position to a distal extended position. The piercing element 306 may include a curved needle 306. Rotating the piercing element 306 relative to the tip portion 310 to pierce the target portion 10A of the pericardium 10 may include rotating the curved needle 306 about a diametrically oriented axle 3. The step of rotating the penetrating element 306 relative to the tip portion 310 to penetrate the target portion 10A of the pericardium 10 may include manipulating a needle rotation actuator 354 disposed on the handle portion 350 of the pericardiotomy device 300.

[0065] A method of creating an opening through the pericardium 10 may include engaging an opening 112, 212, 312 of a tip portion 110, 210, 310 of an end effector 104, 204, 304 of a pericardiotomy device 100, 200, 300 with the pericardium 10. The end effector 104, 204, 304 may include a tip portion 110, 210, 310 and at least one piercing element 106, 206, 306 disposed proximate to the tip portion 110, 210, 310. By applying a vacuum to the tip portion 110, 210, 310, a target portion 10A of the pericardium 10 may be separated from the heart 12. An opening through the target portion 10A of the pericardium 10 may be created by piercing the target portion 10A of the pericardium 10 with the piercing element 106, 206, 306.

[0066] In some embodiments, the piercing element 106 may include a fixed piercing element 106 disposed in a fixed position relative to the tip portion 110. Penetrating the target portion 10A of the pericardium 10 with the piercing element 106 may include using a vacuum to draw the target portion 10A of the pericardium 10 into the tip portion 110 of the end effector 104 into contact with the fixed piercing element 106. The opening may be enlarged by moving the end effector 104 laterally over the pericardium 10.

[0067] In some embodiments, the penetrating element 206 may include a distally movable penetrating element 206. Penetrating the target portion 10A of the pericardium 10 with the penetrating element 206 may include releasing the distally movable penetrating element 206 from a proximal retracted position to a distal extended position.

[0068] In some embodiments, the piercing element 306 includes a rotatable piercing element 306. Penetrating the target portion 10A of the pericardium 10 with the piercing element 306 may include rotating the piercing element 306 from a proximal retracted position to a distal extended position.

[0069] The method of engaging tissue may include repositioning the end effector 304 proximate the tissue surface 10. The penetrator 306 may be rotated longitudinally from a retracted position, out of contact with the tissue surface 10, to an engaged position, in contact with and extending into the tissue surface 10. The end effector 304 may be repositioned away from the tissue surface 10 to tension the tissue 10.

[0070] In some embodiments, the penetrator 306 may be further rotated longitudinally from the engaged position to a piercing position where the penetrator 306 pierces the tissue 10. A vacuum may be applied to the end effector 304 as the end effector 304 is proximate to the tissue surface 10. Repositioning the end effector 304 proximate to the tissue surface 10 may include positioning the end effector 304 to form a seal between the end effector 304 and the tissue surface 10.

[0071] Unless otherwise indicated, it will be understood that any structural, functional, and / or methodological description of any exemplary embodiment herein may apply to any other exemplary embodiment. More generally, it is within the scope of the present disclosure to utilize any one or more features of any one or more other exemplary embodiments described herein in conjunction with any other one or more features of any other one or more other exemplary embodiments described herein. Thus, any combination of any features or embodiments described herein is within the scope of the present disclosure.

[0072] From the above description and summary of the invention, it should be apparent to one of ordinary skill in the art that the methods and apparatus described herein constitute exemplary embodiments according to the present disclosure, but that the scope of the disclosure contained herein is not limited to the precise embodiments described above, and that modifications may be made without departing from the scope defined by the following claims. Likewise, it should be understood that it is not necessary to satisfy any or all of the specific advantages or objectives disclosed herein in order to fall within the scope of the claims, since there may be inherent and / or unexpected advantages, even if not expressly discussed herein.

Claims

1. 1. A pericardiotomy device configured to create an opening through the pericardium, comprising: An elongated shaft; an end effector disposed distally on the shaft, a tip portion including an opening configured to engage a target portion of the pericardium and configured to separate the target portion of the pericardium from an exterior surface of the heart upon application of a vacuum to the tip portion; at least one piercing element disposed within the distal portion such that when a vacuum is applied to the distal portion, the at least one piercing element operates to create an opening in the target portion of the pericardium; An end effector comprising: A pericardiotomy device comprising:

2. The pericardiotomy device of claim 1 , wherein the at least one piercing element is disposed at a fixed position within the tip portion.

3. the opening includes a distal opening; The pericardiotomy device of claim 2 , wherein the at least one piercing element is retracted proximally relative to the distal opening within the tip portion.

4. the at least one piercing element includes a generally triangular blade; The pericardiotomy device of claim 3 , wherein the blades are generally oriented diametrically within the tip portion, the blades including distally directed sharp points.

5. The pericardiotomy device of claim 4 , wherein the blade comprises at least one obliquely oriented cutting edge.

6. The pericardiotomy device of claim 5, further comprising externally visible indicia indicating an orientation of the cutting edge of the blade.

7. The pericardiotomy device of claim 1 , wherein the at least one piercing element is movably disposed relative to the tip portion.

8. The pericardiotomy device of claim 7 , wherein the at least one piercing element is movably disposed distally relative to the tip portion.

9. The pericardiotomy device of claim 8 , wherein the at least one piercing element includes a needle.

10. a handle disposed proximally on the shaft; The pericardiotomy device of claim 9 , wherein the handle comprises a needle release actuator operable to release the needle from a proximal retracted position to a distal extended position.

11. The pericardiotomy device of claim 10 , wherein the handle comprises a needle retraction actuator operable to move the needle from the extended position to the retracted position.

12. The pericardiotomy device of claim 10 , wherein the handle comprises a needle depth actuator operable to adjust the longitudinal position of the extended position of the needle.

13. The pericardiotomy device of claim 9 , wherein the needle comprises a hollow needle.

14. The pericardiotomy device of claim 7 , wherein the at least one piercing element is rotatably and movably disposed relative to the tip portion.

15. The pericardiotomy device of claim 14 , wherein the at least one piercing element includes a needle.

16. a handle disposed proximally on the shaft; The pericardiotomy device of claim 15, wherein the handle comprises a needle rotation actuator operable to rotate the needle from a retracted proximal position to a distal extended position.

17. The end effector includes a needle manipulation mechanism, the needle manipulation mechanism comprises a needle mount rotatably disposed on an axle; The needle is disposed on the needle mount; The pericardiotomy device of claim 16, comprising a linkage operatively coupling the needle rotation actuator and the needle manipulation mechanism.

18. The pericardiotomy device of claim 15 , wherein the needle comprises a curved needle.

19. 2. The pericardiotomy device of claim 1, wherein the tip portion is formed in a bell shape such that a proximal portion of the tip portion has an outer diameter approximately the same as an outer diameter of the shaft and a distal end of the tip portion has an outer diameter larger than the outer diameter of the shaft.

20. 20. The pericardiotomy device of claim 19, wherein the outer diameter of the distal end of the tip portion is approximately twice the outer diameter of the shaft.

21. The pericardiotomy device of claim 1 , further comprising at least one vacuum connector fluidly coupled to the tip portion and configured to fluidly couple to a vacuum source.

22. 1. A method of creating an opening through the pericardium, comprising: applying a vacuum to an opening in a distal portion of an end effector of a pericardiotomy device while the end effector is proximate to the pericardium to draw the pericardium to the opening, the end effector including a piercing element disposed proximate to the opening; increasing the distance between the target portion of the pericardium and an exterior surface of the heart by applying a vacuum to the tip portion to provide a penetration distance; and penetrating the target portion of the pericardium to create an opening therethrough by contacting the target portion of the pericardium with the piercing element while the penetration interval is maintained.

23. the piercing element is disposed in a fixed position relative to the tip portion; 23. The method of claim 22, wherein contacting the target portion of the pericardium with the piercing element comprises retracting the target portion of the pericardium proximally toward the tip portion into contact with a piercing element.

24. enlarging the opening after contacting the target portion of the pericardium with the piercing element; 24. The method of claim 23, wherein enlarging the opening comprises cutting the pericardium laterally with the piercing element by moving the end effector of the pericardiotomy device laterally relative to the pericardium.

25. 25. The method of claim 24, wherein the expanding operation is performed while a vacuum is maintained on the tip portion.

26. the piercing element is movably disposed distally relative to the tip portion; 23. The method of claim 22, wherein contacting the target portion of the pericardium with the piercing element comprises moving the piercing element distally relative to the tip portion to pierce the target portion of the pericardium.

27. 27. The method of claim 26, wherein moving the piercing element distally relative to the tip portion to penetrate the target portion of the pericardium comprises releasing the piercing element from a proximal retracted position and moving it to a distal extended position.

28. 28. The method of claim 27, further comprising the steps of moving the piercing element proximally from the extended position to the retracted position and maintaining the piercing element in the retracted position prior to moving the piercing element distally relative to the tip portion.

29. 28. The method of claim 27, wherein moving the piercing element distally relative to the tip portion comprises manipulating a needle release actuator.

30. 28. The method of claim 27, further comprising manipulating a needle depth actuator to adjust a longitudinal position of the piercing element in the extended position prior to moving the piercing element distally relative to the tip portion.

31. the piercing element is rotatably and movably disposed relative to the tip portion; 23. The method of claim 22, wherein contacting the target portion of the pericardium with the piercing element comprises rotating the piercing element relative to the tip portion.

32. 32. The method of claim 31, wherein rotating the piercing element relative to the tip portion comprises rotating the piercing element from a proximal, retracted position to a distal, extended position.

33. the piercing element comprises a curved needle; 33. The method of claim 32, wherein rotating the piercing element relative to the tip portion to pierce the target portion of the pericardium comprises rotating the curved needle about a diametrically oriented axle.

34. 33. The method of claim 32, wherein rotating the penetrating element relative to the tip portion to penetrate the target portion of the pericardium comprises manipulating a needle rotation actuator disposed on a handle portion of the pericardiotomy device.

35. The step of rotating the penetrating element from the proximal retracted position to the distal extended position comprises: rotationally rotating the piercing element from the proximal retracted position to a partially extended position between the retracted position and the extended position to cause the piercing element to engage the target portion of the pericardium; verifying engagement of the piercing element with the target portion of the pericardium; and rotating the piercing element from the partially extended position to the extended position to cut the targeted portion of the pericardium to create the opening therethrough.

36. 36. The method of claim 35, further comprising the step of moving the pericardiotomy device proximally to further increase the distance between the target portion of the pericardium and the exterior surface of the heart before rotating the piercing element from the partially extended position to the extended position.

37. 1. A method of creating an opening through the pericardium, comprising: engaging an opening in a distal portion of an end effector of a pericardiotomy device with the pericardium, the end effector comprising the distal portion and at least one piercing element disposed proximate to the distal portion; separating a targeted portion of the pericardium from the heart by applying a vacuum to the tip portion; and creating an opening through the target portion of the pericardium by penetrating the target portion of the pericardium with the piercing element.

38. the piercing element includes a fixed piercing element disposed in a fixed position relative to the tip portion; 38. The method of claim 37, wherein penetrating the target portion of the pericardium with the piercing element comprises using a vacuum to draw the target portion of the pericardium into the distal portion of the end effector and into contact with the fixed piercing element.

39. 40. The method of claim 38, further comprising enlarging the opening by moving the end effector laterally on the pericardium.

40. the piercing element includes a distally movable piercing element; 38. The method of claim 37, wherein penetrating the target portion of the pericardium with the penetrating element comprises releasing the distally movable penetrating element from a proximal retracted position to a distal extended position.

41. the piercing element comprises a rotatable piercing element; 38. The method of claim 37, wherein penetrating the target portion of the pericardium with the piercing element comprises rotating the piercing element from a proximal, retracted position to a distal, extended position.

42. 1. A method of engaging tissue, comprising: repositioning the end effector adjacent to the tissue surface; longitudinally rotating the penetrator from a retracted position not in contact with the tissue surface to an engaged position in contact with and extending into the tissue surface; and repositioning the end effector away from the tissue surface to tension the tissue.

43. 43. The method of claim 42, further comprising continuing to rotate the penetrator longitudinally from the engagement position to a piercing position in which the penetrator pierces the tissue.

44. 43. The method of claim 42, further comprising applying a vacuum to the end effector as the end effector is proximate to the tissue surface, and wherein repositioning the end effector proximate to the tissue surface comprises positioning the end effector to form a seal between the end effector and the tissue surface.

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