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. Patent Application No. 17 / 588,227, filed Jan. 29, 2022, and U.S. Provisional Patent Application No. 63 / 294,455, filed Dec. 29, 2021, both of which are incorporated herein by reference. 【Background Art】 【0002】 The present disclosure is directed to medical devices and devices and related methods, and particularly to surgical devices for creating an opening in the pericardium and related methods. 【0003】 The present disclosure contemplates that some internal anatomical structures can be at least partially covered by one or more tissue layers. For example, in mammals, the heart is partially surrounded by a sac - like tissue called the pericardium. 【0004】 Furthermore, 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 heart procedures, it may be necessary for surgical instruments to penetrate the pericardium to enable direct access to the heart. As used herein, "pericardiotomy" can refer to a surgical procedure in which an opening through the patient's pericardium is created. Pericardiotomy can be performed to enable a surgeon to access a patient's heart in connection with, for example, cardiac ablation for treating atrial fibrillation and / or occlusion of the left atrial appendage. 【0005】 This disclosure considers the challenges that surgeons may face when performing pericardiotomy, particularly in relation to minimally invasive procedures. 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., the heart wall). In addition, when pericardiotomy is performed while the patient's heart is beating (e.g., without cardiopulmonary bypass), the movement of the heart and / or pericardium can increase the complexity of the procedure. 【0006】 While pericardiotomy is 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. This disclosure includes various improvements that may improve the structure, operation, and use of pericardiotomy devices. 【0007】 One aspect of the present disclosure is to provide a pericardiotomy device configured to create an opening through the pericardium. The pericardiotomy device may include an elongated shaft and an end effector positioned distally on the shaft. The end effector may include a tip portion having 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 the outer surface of the heart when a vacuum is applied to the tip portion. The end effector may include at least one penetrating element positioned within the tip portion such that when a vacuum is applied to the tip portion, at least one penetrating element acts to create an opening in the target portion of the pericardium. 【0008】 In detailed embodiments, the penetrating element may be positioned in a fixed location within the tip portion. The opening may include a distal opening, and / or the penetrating element may be retracted proximally relative to the distal opening within the tip portion. The penetrating element may include a generally triangular blade, and / or the blade may be oriented generally diametrically within the tip portion, and / or include a distally oriented sharp point. The blade may include at least one obliquely oriented cutting edge. The pericardiotomy device may include an externally visible mark indicating the orientation of the cutting edge of the blade. 【0009】 In detailed embodiments, the penetrating element may be movably positioned relative to the tip portion. The penetrating element may be movably positioned distal to the tip portion. The penetrating element may include a needle. The pericardiotomy device may include a handle positioned proximal to 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 in the extended position. In some embodiments, the needle may include a hollow needle. 【0010】 In detailed embodiments, the penetrating element may be rotatably movable relative to the tip portion. The penetrating element may include a needle. The pericardiotomy device may include a handle located proximal to the shaft, and / or the handle may include a needle rotation actuator that can be operated to rotate the needle from a retracted proximal position to a distal extended position. The end effector may include a needle operating mechanism that may include a needle mount rotatably located on the axle. The needle may be positioned on the needle mount. The pericardiotomy device may include a linkage that operatively connects the needle rotation actuator and the needle operating mechanism. In some embodiments, the needle may include a curved needle. 【0011】 In detailed embodiments, the tip portion may be formed in a bell shape such that the proximal end of the tip portion has an outer diameter approximately the same as the outer diameter of the shaft, and the distal end of the tip portion has an outer diameter larger than the outer diameter of the shaft. In some embodiments, the outer diameter of the distal end of the tip portion may be about twice the outer diameter of the shaft. 【0012】 In a detailed embodiment, the pericardiotomy device may include at least one vacuum connector configured to be fluidly coupled to a vacuum source and to a tip portion. 【0013】 One aspect of the present disclosure provides a method for creating an opening through the pericardium, comprising the steps of: applying a vacuum to the opening of the tip portion of the end effector of a pericardiotomy device while the end effector is in close proximity to the pericardium in order to draw the pericardium to the opening, wherein the end effector includes a penetrating element positioned in close proximity to the opening; increasing the distance between a target portion of the pericardium and the outer surface of the heart by applying a vacuum to the tip portion to create a penetrating gap; and / or penetrating the target portion of the pericardium to create an opening through it by bringing the target portion of the pericardium into contact with the penetrating element while the penetrating gap is maintained. 【0014】 In detailed embodiments, the penetrating element may be positioned in a fixed position relative to the tip. The step of bringing the target portion of the pericardium into contact with the penetrating element may include the step of drawing the target portion of the pericardium proximal to the tip and bringing it into contact with the penetrating element. After bringing the target portion of the pericardium into contact with the penetrating element, the method may include the step of enlarging the opening. The step of enlarging the opening may include the step of moving the end effector of the pericardiotomy device laterally relative to the pericardium, thereby laterally cutting the pericardium with the penetrating element. The enlargement operation may be performed while a vacuum is maintained at the tip. 【0015】 In detailed embodiments, the penetrating element may be positioned to be movable distal to the tip portion. The step of bringing the target portion of the pericardium into contact with the penetrating element may include the step of moving the penetrating element distal to the tip portion to penetrate the target portion of the pericardium. The step of moving the penetrating element distal to the tip portion to penetrate the target portion of the pericardium may include the step of releasing the penetrating element from a proximal retracted position and moving it to a distal extended position. The method may include the step of moving the penetrating element proximal from the extended position to a retracted position and holding the penetrating element in the retracted position before moving the penetrating element distal to the tip portion. The step of moving the penetrating element distal to the tip portion may include the step of operating the needle release actuator. The method may include the step of operating the needle depth actuator to adjust the longitudinal position of the penetrating element in the extended position before moving the penetrating element distal to the tip portion. 【0016】 In detailed embodiments, the penetrating element may be rotatably movable relative to the tip portion. The step of bringing the target portion of the pericardium into contact with the penetrating element may include the step of rotating the penetrating element relative to the tip portion to penetrate the target portion of the pericardium. The step of rotating the penetrating element relative to the tip portion to penetrate the target portion of the pericardium may include the step of rotating the penetrating element from a proximal retracted position to a distal extended position. The penetrating element may include a curved needle. The step of rotating the penetrating element relative to the tip portion to penetrate the target portion of the pericardium may include the step of rotating the curved needle around a diametrically oriented axle. The step of rotating the penetrating element relative to the tip portion to penetrate the target portion of the pericardium may include the step of operating a needle rotation actuator located on the handle portion of the pericardiotomy device. 【0017】 In a detailed embodiment, the step of rotating the penetrating element from a proximal retracted position to a distal extended position may include the steps of: rotating the penetrating element from a proximal retracted position to a partially extended position between the retracted and extended positions to engage the penetrating element with a target portion of the pericardium; confirming the engagement between the penetrating element and the target portion of the pericardium; and / or rotating the penetrating element from the partially extended position to the extended position to cut the target portion of the pericardium and create an opening through it. In a detailed embodiment, the method may include the step of moving the pericardiotomy device proximal to further increase the distance between the target portion of the pericardium and the outer surface of the heart before rotating the penetrating element from the partially extended position to the extended position. 【0018】 One aspect of the present disclosure provides a method for creating an opening through the pericardium, comprising the steps of engaging the opening of the tip portion of an end effector of a pericardiotomy device with the pericardium, wherein the end effector comprises a tip portion and at least one penetrating element positioned adjacent 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 penetrating element may include a fixed penetrating element positioned in a fixed location relative to the tip portion. The step of penetrating the target portion of the pericardium with the penetrating element may include using a vacuum to pull the target portion of the pericardium into the tip portion of the end effector and bring it into contact with the fixed penetrating element. The method may include the step of expanding the opening by moving the end effector laterally over the pericardium. 【0020】 In detailed embodiments, the penetrating element may include a distally movable penetrating element. The step of penetrating a target portion of the pericardium with the penetrating element may include the step of releasing the distally movable penetrating element from a proximal retracted position to a distally extended position. 【0021】 In detailed embodiments, the penetrating element may include a rotatable penetrating element. The step of penetrating a target portion of the pericardium with the penetrating element may include the step of rotating the penetrating element from a proximal retracted position to a distal extended position. 【0022】 One aspect of the present disclosure provides a method for engaging tissue, comprising the steps of: repositioning an end effector in close proximity to the tissue surface; rotating a penetrating body longitudinally from a retracted position not in contact with the tissue surface to an engaging position in contact with the tissue surface and extending into the tissue surface; and / or repositioning the end effector in the direction opposite to the tissue surface in order to tension the tissue. 【0023】 In detailed embodiments, the method may further include the step of continuing to rotate the penetrating body longitudinally from the engagement position to the puncture position in which the penetrating body penetrates the tissue. The method may further include the step of applying a vacuum to the end effector when the end effector is in close proximity to the tissue surface. The step of repositioning the end effector in close proximity to the tissue surface may include the step of positioning the end effector so as to form a seal between the end effector and the tissue surface. 【0024】 One aspect of this disclosure is to provide any method, operation, process, system, device, and / or apparatus relating to any of the aforementioned aspects or described elsewhere in this specification. 【0025】 One aspect of this disclosure is to provide any combination of any of the aforementioned embodiments or any one or more elements described elsewhere in this specification. 【0026】 Examples of embodiments will be described in conjunction with the accompanying drawings, each relating to at least some aspects of the present disclosure. [Brief explanation of the drawing] 【0027】 [Figure 1] This is a perspective view of an example of a pericardiotomy device including a fixed blade. [Figure 2] It is a detailed perspective view of the proximal portion of the pericardiotomy device of FIG. 1. [Figure 3] It is a detailed perspective view of the distal portion of the pericardiotomy device of FIG. 1. [Figure 4] It is a detailed perspective view of the distal portion of the pericardiotomy device of FIG. 1. [Figure 5] It is a simplified cross-sectional view of the distal portion of the pericardiotomy device of FIG. 1. [Figure 6] It is a perspective view of an alternative example of a pericardiotomy device including a distally movable needle. [Figure 7] It is a detailed perspective view of the proximal portion of the pericardiotomy device of FIG. 6. [Figure 8] It is a detailed perspective view of the distal portion of the pericardiotomy device of FIG. 6 with the needle in the extended position. [Figure 9] It is a detailed perspective view of the distal portion of the pericardiotomy device of FIG. 6 with the needle in the retracted position. [Figure 10] It is a detailed side perspective view of the distal portion of the pericardiotomy device of FIG. 6 with the needle in the extended position. [Figure 11] It is a simplified cross-sectional view of the distal portion of the pericardiotomy device of FIG. 6. [Figure 12] It is a simplified perspective view of the needle mechanism of the pericardiotomy device of FIG. 6. [Figure 13] It is a perspective view of an alternative example of a pericardiotomy device including a rotatable needle. [Figure 14] It is a detailed perspective view of the distal portion of the pericardiotomy device of FIG. 13 with the needle in the retracted position. [Figure 15] It is a detailed perspective view of the distal portion of the pericardiotomy device of FIG. 13 with the needle in the extended position. [Figure 16] It is a detailed perspective view of the distal portion of the pericardiotomy device of FIG. 13. [Figure 17] It is a simplified cross-sectional view of the distal portion of the pericardiotomy device of FIG. 13. [Figure 18] It is a simplified perspective view of the needle mechanism of the pericardiotomy device of FIG. 13. [Figure 19] It is a cross-sectional view of the handle of the pericardiotomy device of FIG. 13. [Modes for carrying out the invention] 【0028】 Examples of embodiments of the present disclosure, including devices, methods, and techniques relating to medical and surgical procedures such as creating openings through the pericardium, are described and illustrated below. Naturally, it will be apparent to those skilled in the art that the embodiments discussed below are examples and can be reconfigured without departing from the scope and spirit of the disclosure. It should also be understood that variations of the examples of embodiments conceivable by those skilled in the art may simultaneously include parts of the disclosure. However, for clarity and accuracy, the examples of embodiments discussed below may include any steps, methods, and features that those skilled in the art should recognize as not essential to entering the scope of the disclosure. Unless otherwise expressly stated, any feature or function described in relation to any example of an embodiment may be used in conjunction with features or functions described in relation to other examples of embodiments. Repetition of descriptions of similar features and functions is omitted for brevity. 【0029】 Figure 1 is a perspective view of example 100 of a pericardiotomy device including a fixed blade; Figure 2 is a detailed perspective view of the proximal portion of the pericardiotomy device 100 of Figure 1; Figure 3 is a detailed perspective view of the distal portion of the pericardiotomy device 100 of Figure 1; Figure 4 is a detailed perspective view of the distal portion of the pericardiotomy device 100 of Figure 1; and Figure 5 is a simplified cross-sectional view of the distal portion of the pericardiotomy device 100 of Figure 1, all of which are in accordance with at least some aspects of the present disclosure. In general, the pericardiotomy device 100 may be similar in structure and operation to other pericardiotomy devices described herein, and repetition of descriptions of similar elements is omitted for brevity. Referring to Figures 1 and 5, the pericardiotomy device 100 may be used in connection with a pericardiotomy procedure that includes creating an opening through the patient's pericardium 10 to obtain access to the patient's heart 12, for example. Referring to Figure 1, the pericardiotomy device 100 can be operatively coupled to the vacuum source 14. 【0030】 For clarity, the following description refers to the distal direction 16 and the proximal direction 18. The proximal direction 18 may be generally opposite to the distal direction 16. As used herein, “distal” may refer to a direction generally away from the operator of the system or device (e.g., a surgeon), such as the direction toward the most distal end of a device inserted into the patient’s body. As used herein, “proximal” may refer to a direction generally toward the operator of the system or device (e.g., a surgeon), such as the direction toward the most distal end of a device inserted into the patient’s body. However, it should be understood that the examples of directions referred herein are for illustrative and clarification purposes only and should not be considered limiting. 【0031】 Referring to Figures 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 positioned generally distal to the shaft 102. In some 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 the normal intended use of the device 100), and such properties 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-circular column defining an internal channel 132 extending through it in the longitudinal direction. 【0032】 Referring to Figures 3-5, in the illustrated embodiments, the end effector 104 includes a tip portion 110 and a penetrating element such as one or more blades 106 configured to create an opening through the pericardium 10. In the illustrated embodiments, the blades 106 are fixed to the tip portion 110. That is, the blades 106 are positioned 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 positioned at least partially within the tip portion 110. In the illustrated embodiments, the blades 106 may be oriented generally in the diametrical direction. Referring to Figure 3, in some embodiments, the blades 106 may have a generally triangular shape with a distally pointed tip. In some embodiments, the blades 106 may include one or more cutting edges 106A that may be oriented generally obliquely. 【0033】 Referring to Figures 1, 3, 4, and 5, the tip portion 110 may include an opening, such as a distal opening 112, configured to engage with the pericardium 10 and allow the pericardium 10 to contact the blade 106. In some embodiments, the distal opening 112 may be substantially circular. In some embodiments, the tip portion 110 may be constructed from a substantially transparent material (e.g., a substantially optically transparent material), thereby facilitating visibility through the tip portion 110, such as the visibility of the blade 106. In other embodiments, at least a portion of the tip portion 110 may be constructed from at least partially translucent and / or opaque materials, such as, but not limited to, radiopaque materials. 【0034】 Referring to Figures 1 and 2, the pericardiotomy device 100 may include at least one vacuum connector 122 that can be used to fluidly connect the pericardiotomy device 100 to a vacuum source 14. In the illustrated embodiment, the vacuum connector 122 is located approximately proximal on the shaft 102 and is configured to connect to a vacuum line 124 having 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 located on the end of the line 124 that is attached to the vacuum source 14. An example of a vacuum source 14 may include a vacuum pump and a connection to a central vacuum system, such as those available in a hospital or surgical facility. 【0035】 Referring to Figures 1 and 5, a vacuum from the vacuum source 14 can be selectively applied to the tip portion 110 via an internal channel 132 of the shaft 102, for example. The channel 132 may be configured as a vacuum conduit that fluidly interposes between the tip portion 110 and the vacuum connector 122. The application of vacuum to the tip portion 110 (e.g., via the vacuum connector 122 and the internal channel 132) can act to pull the target portion 10A of the pericardium 10 into the tip portion 110, as indicated by arrow 134. In this embodiment, the pull of the target portion 10A of the pericardium 10 into the tip portion 110 due to the application of vacuum causes the pericardium 10 to come into contact with the blade 106. In the illustrated embodiment, the blade 106 is retracted proximally to the distance indicated by arrow 134 within the tip portion 110. In other embodiments, the blade 106 may be positioned at other proximal-distal locations within the tip portion 110, such as at substantially the same height as the distal end of the tip portion 110 (e.g., zero-distance retraction). In the illustrated embodiment, because the blade 106 is retracted proximal within the tip portion 110, the application of vacuum pulls the pericardium 10 proximal to the tip portion 110, creating and / or increasing the distance between the surface of the heart 12 and the location where the blade 106 is used to cut through the pericardium 10. This can reduce the possibility of damage to the heart 12 (e.g., due to contact with the blade 106). 【0036】 Referring to Figure 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 (e.g., about 12 mm) that is approximately the same as the outer diameter 103 of the shaft 102. The distal end 111 of the tip portion 110 may have an outer diameter 111A (e.g., about 13 mm) that is larger than the outer diameter 103 of the shaft 102. In some embodiments, the radially outer surface of the tip portion 110 may be continuously curved, such as curving in a generally concave shape between the proximal portion of the tip portion 110 near the shaft 102 and the distal end 111 of the tip portion 110. 【0037】 Referring to Figure 4, some embodiments may include an externally visible mark 160 that can be configured to indicate to the user the orientation of the pericardiotomy device 100, such as the orientation of the blade 106. In the illustrated embodiment, the mark 160 indicates the radial direction, which is roughly aligned with the oblique cutting edge 106A of the blade 106. 【0038】 Referring to Figures 1 and 5, when in use, the pericardiotomy device 100 may be positioned so that the distal end 111 of the tip portion 110 is in contact with the pericardium 10. Vacuum may be applied to the tip portion 110, thereby drawing the target portion 10A of the pericardium proximal to the tip portion 110. The target portion 10A of the pericardium may be drawn proximal to contact the blade 106 (e.g., the distally facing point), thereby cutting through the target portion 10A of the pericardium and creating an opening through the pericardium 10. If it is desirable 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, for example, while the vacuum is maintained, thereby allowing the blade 106 to cut the pericardium 10 laterally. For example, the pericardiotomy device 100 may be moved in the direction generally indicated by the mark 160 to cut the pericardium 10 using the cutting edge 106A of the blade 106 to create an elongated opening. The vacuum may be released and the pericardiotomy device 100 may be moved away from the target portion 10A of the pericardium. 【0039】 Figure 6 is a perspective view of an alternative example 200 of a pericardiotomy device including a distally movable needle; Figure 7 is a detailed perspective view of the proximal portion of the pericardiotomy device 200 of Figure 6; Figure 8 is a detailed perspective view of the distal portion of the pericardiotomy device 200 of Figure 6 with the needle in the extended position; Figure 9 is a detailed perspective view of the distal portion of the pericardiotomy device 200 of Figure 6 with the needle in the retracted position; Figure 10 is a detailed lateral perspective view of the distal portion of the pericardiotomy device 200 of Figure 6 with the needle in the extended position; Figure 11 is a simplified cross-sectional view of the distal portion of the pericardiotomy device 200 of Figure 6; and Figure 12 is a simplified perspective view of the needle mechanism of the pericardiotomy device 200 of Figure 6, all of which are in accordance with at least some aspects 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 repetition of the description of similar elements is omitted for brevity. Referring to Figure 11, the pericardiotomy device 200 may be used in connection with a pericardiotomy procedure that includes creating an opening through the patient's pericardium 10 to obtain access to the patient's heart 12, for example. Referring to Figure 6, the pericardiotomy device 200 may be operatively coupled to a vacuum source 14. 【0040】 Referring to Figures 6-11, in the illustrated embodiments, the pericardiotomy device 200 includes an elongated, generally tubular shaft 202, an end effector 204 positioned generally distally on the shaft 202, and a handle 250 positioned generally proximal on the shaft 202. In some 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 the normal intended use of the device 200), and such properties may vary over the proximal-distal length of the shaft 202. In the illustrated embodiments, the shaft 202 is in the form of a tubular right-circular column defining an internal channel 232 extending through it in the longitudinal direction. 【0041】 Referring to Figures 8 and 11, in the illustrated embodiments, the end effector 204 includes a tip portion 210 and a penetrating element such as one or more needles 206 configured to create an opening through the pericardium 10. The needles 206 may be movably positioned in the rotational and / or longitudinal (proximal-distal) direction, but not limited to, so as to selectively extend at least partially into the tip portion 210. Referring to Figures 8, 10, and 12, in some embodiments, the needles 206 may be hollow and / or have an inclined sharp point. 【0042】 Referring to Figures 6 and 8-11, the tip portion 210 may include an opening, such as a distal opening 212, configured to engage with the pericardium 10 and allow the needle 206 to contact the pericardium 10. In some embodiments, the distal opening 212 may be substantially circular. In some embodiments, the tip portion 210 may be constructed from a substantially transparent material (e.g., a substantially optically transparent material), thereby facilitating visibility through the tip portion 210, such as the visualization of the needle 206. In other embodiments, at least a portion of the tip portion 210 may be constructed from at least partially translucent and / or opaque materials, such as, but not limited to, radiopaque materials. 【0043】 Referring to Figures 6 and 7, the pericardiotomy device 200 may include at least one vacuum connector 222 that can be used to fluidly connect the pericardiotomy device 200 to a vacuum source 14. In the illustrated embodiment, the vacuum connector 222 is located approximately proximal on the shaft 202 and is configured to connect to a vacuum line 124 having 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 located on the end of the line 124 that is attached to the vacuum source 14. An example of the vacuum source 14 may include a vacuum pump and a connection to a central vacuum system, such as those available in a hospital or surgical facility. 【0044】 Referring to Figures 6 and 11, a vacuum from the vacuum source 14 can be selectively applied to the tip portion 210 via an internal channel 232 of the shaft 202, for example. The channel 232 may be configured as a vacuum conduit fluidly interposed between the tip portion 210 and the vacuum connector 222. The application of vacuum to the tip 210 (e.g., via the vacuum connector 222 and the internal channel 232) can act to pull the target portion 10A of the pericardium 10 into the tip portion 210, as indicated by arrow 234. In this embodiment, the pull of the target portion 10A of the pericardium 10 into the tip portion 210 by the application of vacuum pulls the pericardium 10 into the operating range of the needle 206. In the illustrated embodiment, at its most distal extended position, the needle 206 is retracted proximally to the distance indicated by arrow 234 within the tip portion 210. In other embodiments, the needle 206 may be positioned at other proximal-distal locations within the tip portion 210, such as at substantially the same height as the distal end of the tip portion 210 (e.g., zero-distance retraction). In the illustrated embodiment, since the needle 206 is retracted proximally within the tip portion 210 even in its most distal extended position, the application of vacuum pulls the pericardium 10 proximally toward the tip portion 210, creating and / or increasing the distance between the surface of the heart 12 and the location where the needle 206 is used to puncture the pericardium 10. This can reduce the possibility of injury to the heart 12 (e.g., due to contact with the needle 206). 【0045】 Referring to Figure 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 (e.g., about 5.0 mm) that is approximately the same as the outer diameter 203 of the shaft 202. 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 curving in a generally concave shape 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., near the distal end 211) may be about 10.5 mm. Thus, in some embodiments, the maximum outer diameter 211A of the tip portion 210 may be about twice the outer diameter 203 of the shaft 202. 【0046】 Referring to Figures 6 and 7, in the illustrated embodiment, the handle 250 includes a grip portion 252 which may be configured to be grasped by a user (e.g., a surgeon). The handle 250 includes a needle retraction actuator 254 located proximal to the handle. The needle retraction actuator 254 may be operated to move the needle 206 from the extended position (Figures 10 and 11) to the retracted position 206A (Figure 9) (e.g., pulled roughly proximal). The handle 250 includes a needle release actuator 256 which may be operated to release the needle from the retracted position 206A (Figure 11) to the extended position (Figures 10 and 11). In the illustrated embodiment, the needle release actuator 256 includes a button located adjacent to the grip portion 252. The handle 250 includes a needle depth actuator 258 which may be operated to adjust the longitudinal (e.g., proximal-distal) position of the needle 206 in the extended position. In the illustrated embodiment, the needle depth actuator 258 includes a generally cylindrical rotatable element positioned concentrically with and / or distal to the grip portion 252. The handle 250 may include needle depth marks 260 provided to indicate various predetermined positions of the needle depth actuator 258. The actuators 254, 256, and 258 are operatively coupled to the distal portion of the pericardiotomy device 200 (e.g., the end effector 204) by one or more suitable mechanical linkages 262 (Figure 11), etc. 【0047】 In some embodiments, the pericardiotomy device 200 may include a needle operating mechanism, which may be configured to hold the needle 206 in a retracted position and / or extend the needle 206 when a needle release actuator 256 is operated, for example, within the handle 250 and / or within the end effector 204. Generally, the needle 206 can be placed in the retracted position by operating the needle retraction actuator 254. In some embodiments, retracting the needle 206 may cause a spring forming part of the needle operating mechanism to be elastically deformed. The needle 206 may remain in the retracted position (with the spring elastically deformed) until the needle release actuator 256 is operated. When 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】 When ready for use, the pericardiotomy device 200 can be prepared by operating the needle retraction actuator 254 to move the needle 206 from the extended position to the retracted position 206A. The needle depth actuator 258 can be operated to select a desired longitudinal position of the needle 206 in the extended position. The pericardiotomy device 200 can be positioned so that the distal end 211 of the tip portion 210 is in contact with the pericardium 10. A vacuum can be applied to the tip portion 210 so that the target portion 10A of the pericardium is drawn proximally toward the tip portion 210. The needle release actuator 256 can be operated to release the needle from the retracted position 206A to the extended position so that the needle penetrates the target portion 10A of the pericardium and creates an opening through the pericardium 10. The vacuum can be released so that the pericardiotomy device 200 is moved away from the target portion 10A of the pericardium. 【0049】 Figure 13 is a perspective view of an alternative example 300 of a pericardiotomy device including a rotatable needle; Figure 14 is a detailed perspective view of the distal portion of the pericardiotomy device 300 of Figure 13 with the needle 306 in the retracted position; Figure 15 is a detailed perspective view of the distal portion of the pericardiotomy device 300 of Figure 13 with the needle 306 in the extended position; Figure 16 is a detailed perspective view of the distal portion of the pericardiotomy device 300 of Figure 13; Figure 17 is a simplified cross-sectional view of the distal portion of the pericardiotomy device 300 of Figure 13; Figure 18 is a simplified perspective view of the needle mechanism of the pericardiotomy device 300 of Figure 13; and Figure 19 is a cross-sectional view of the handle of the pericardiotomy device 300 of Figure 13, all of which are in accordance with 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 repetition of the description of similar elements is omitted for brevity. Referring to Figure 17, the pericardiotomy device 300 may be used in connection with a pericardiotomy procedure that includes creating an opening through the patient's pericardium 10 to obtain access to the patient's heart 12, for example. Referring to Figure 13, the pericardiotomy device 300 may be operatively coupled to a vacuum source 14. 【0050】 Referring to Figures 13-17, in the illustrated embodiments, the pericardiotomy device 300 includes an elongated, generally tubular shaft 302, an end effector 304 positioned generally distally on the shaft 302, and a handle 350 positioned generally proximal on the shaft 302. In some 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 the normal intended use of the device 300), and such properties may vary over the proximal-distal length of the shaft 302. In the illustrated embodiments, the shaft 302 is in the form of a tubular right-circular column defining an internal channel 332 extending through it in the longitudinal direction. 【0051】 Referring to Figures 14, 15, and 17, in the illustrated embodiments, the end effector 304 includes a tip portion 310 and a penetrating element such as one or more needles 306 configured to create an opening through the pericardium 10. The needles 306 may be arranged to move longitudinally and / or radially so as to allow selective longitudinal rotation at least partially within the tip portion 310. In some embodiments, the needles 306 may be curved and / or have an inclined sharp point. In alternative embodiments, the needles 306 may be movable and / or repositionable in any direction and / or around any axis relative to the tip portion 310. For example, the needles 306 may be rotatable around a longitudinally oriented axis. 【0052】 The tip portion 310 may include an opening, such as a distal opening 312, configured to engage with the pericardium 10 and allow the needle 306 to contact the pericardium 10. In some embodiments, the distal opening 312 may be substantially circular. In some embodiments, the tip portion 310 may be constructed from a substantially transparent material (e.g., a substantially optically transparent material), thereby facilitating visibility through the tip portion 310, such as the visibility of the needle 306. In other embodiments, at least a portion of the tip portion 310 may be constructed from at least partially translucent and / or opaque materials, such as, but not limited to, radiopaque materials. 【0053】 Referring to Figure 13, the pericardiotomy device 300 may include at least one vacuum connector 322 that can be used to fluidly connect the pericardiotomy device 300 to a vacuum source 14. In the illustrated embodiment, the vacuum connector 322 is located approximately proximal on the shaft 302 and is configured to connect to a vacuum line 124 having 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 located on the end of the line 124 that is attached to the vacuum source 14. An example of the vacuum source 14 may include a vacuum pump and a connection to a central vacuum system, such as those available in a hospital or surgical facility. 【0054】 Referring to Figures 13 and 17, a vacuum from the vacuum source 14 can be selectively applied to the tip portion 310 via an internal channel 332 of the shaft 302, for example. The channel 332 may be configured as a vacuum conduit fluidly interposed between the tip portion 310 and the vacuum connector 322. The application of vacuum to the tip 310 (e.g., via the vacuum connector 322 and the internal channel 332) can act to draw the target portion 10A of the pericardium 10 into the tip portion 310, as indicated by arrow 334. In this embodiment, the drawing of the target portion 10A of the pericardium 10 into the tip portion 310 by the application of vacuum draws the pericardium 10 into the operating range of the needle 306. In the illustrated embodiment, at its most distal extended position, the needle 306 is retracted proximally to the distance indicated by arrow 334 within the tip portion 310. In other embodiments, the needle 306 may be positioned at other proximal-distal locations within the tip portion 310, such as at substantially the same height as the distal end of the tip portion 310 (e.g., zero-distance retraction). In the illustrated embodiment, since the needle 306 is retracted proximally within the tip portion 310 even at its most distal extended position, the application of vacuum pulls the pericardium 10 proximally toward the tip portion 310, creating and / or increasing the distance between the surface of the heart 12 and the location where the needle 306 is used to puncture the pericardium 10. This can reduce the possibility of injury to the heart 12 (e.g., due to contact with the needle 306). 【0055】 Referring to Figure 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 (e.g., about 10.0 mm) that is approximately the same as the outer diameter 303 of the shaft 302. The distal end 311 of the tip portion 310 may have an outer diameter 311A ​​that is larger 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 curving in a generally concave shape 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., near the distal end 311) may be about 11.5 mm. 【0056】 Referring to Figure 13, in the illustrated embodiment, the handle 350 includes a grip portion 352 which may be configured to be grasped by a user (e.g., a surgeon). The handle 350 includes a needle rotation actuator 354 located proximal to the handle. The needle rotation actuator 354 may be operated to rotate the needle 306 longitudinally from a retracted position (Figure 14) to an extended position (Figure 15) (e.g., pulled roughly proximal). The actuator 354 is operatively coupled to the distal portion (e.g., end effector 304) of the pericardiotomy device 300 by one or more suitable mechanical linkages 362 (Figure 17), etc. 【0057】 Referring to Figures 13-15 and 17-19, in some embodiments, the pericardiotomy device 300 may include a needle manipulation mechanism 364, which may be configured to extend / retract and / or rotate the needle 306 longitudinally when a needle rotation actuator 354 is operated, for example, within an end effector 304. Generally, the needle 306 may be mounted on a mount 366, which may be rotatably positioned on a diametrically oriented axle 368. Operation of the needle rotation actuator 354 on the handle 350 may work to rotate the mount 366 and the needle 306 around 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 toward the grip portion 352 in the pressed position 372 can 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 Figure 19. Moving the actuator arm 356 downward (as indicated by the arrow in Figure 19) pulls the cable 358, which includes a portion of the linkage 362, generally proximal, thereby causing the mount 366 and needle 306 to rotate to the extended position (see Figure 18). Releasing the needle rotation actuator 354 so that it can move away from the grip portion 352 of the handle 350 allows for distal movement of the cable 358. A tension spring 360 is coupled to a second cable 374, which includes a portion of the linkage 362. The second cable 374 is operatively coupled to a rotatable mount 366 such that rotation from the retracted position to the extended position causes the cable 374 to move distally, thereby extending the spring 360. When the needle rotation actuator 354 is released, the spring 360 pulls the second cable 374 proximal, 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 can extend even further distally than when the needle is in the retracted position. 【0059】 During use, the pericardiotomy device 300 may be positioned so that the distal end 311 of the tip portion 310 is in contact with the pericardium 10. Vacuum may be applied to the tip portion 310, thereby drawing the target portion 10A of the pericardium proximal to the tip portion 310. The needle rotation actuator 354 may be operated to rotate the mount 366 and needle 306 longitudinally to the extended position, thereby penetrating the target portion 10A of the pericardium and creating an opening through the pericardium 10. Vacuum may be released, and the pericardiotomy device 300 may be moved away from the target portion 10A of the pericardium. 【0060】 Examples of several embodiments may be configured for multiple-stage longitudinal rotation of the needle 306. For example, after applying vacuum to the tip portion 310 and retracting the target portion 10A of the pericardium proximal to the tip portion 310, the needle 306 may be rotated from a retracted position to a partially extended position (e.g., rotationally between the retracted position and the fully extended position). In the partially extended position, the needle 306 can engage and / or hold (e.g., puncture the pericardium 10) the pericardium 10 without completely cutting through it. Thus, with the needle 306 in the partially extended position, the user can confirm where the pericardium is engaged and / or pull the pericardiotomy device 300 proximal to further tension the pericardium 10 away from the heart 12. If the positioning and / or engagement of the pericardium 10 is unsatisfactory, the needle 306 may be returned to the retracted position, thereby releasing the pericardium 10. If the positioning and / or engagement of the pericardium 10 is satisfactory, the needle 306 can be rotated from a partially extended position to a fully extended position, thereby cutting the pericardium 10 and creating an opening through the pericardium 10. Similarly, in some embodiments, the opening can be enlarged by using the movement and / or rotation of the needle 306 to cut the tissue and create an elongated and / or generally circular opening. 【0061】 Examples of methods for 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: A method for creating an opening through the pericardium 10 may include the step of applying a vacuum to the openings 112, 212, 312 of the tip portions 110, 210, 310 of the end effectors 104, 204, 304 of the pericardiotomy devices 100, 200, 300 while the end effectors 104, 204, 304 are in close proximity to the pericardium 10. The end effectors 104, 204, 304 may include through elements 106, 206, 306 positioned in close proximity to the openings 112, 212, 312. By applying a vacuum to the tip portions 110, 210, and 310, the distances 134, 234, and 334 between the target portion 10A of the pericardium 10 and the outer surface of the heart 12 can be increased, resulting in a penetration gap. While the penetration gap is maintained, the target portion 10A of the pericardium 10 can be brought into contact with the penetration elements 106, 206, and 306, thereby penetrating the target portion 10A of the pericardium 10 and creating an opening through it. 【0062】 In some embodiments, the penetrating element 106 may be positioned in a fixed position relative to the tip portion 110. The step of bringing the target portion 10A of the pericardium 10 into contact with the penetrating element 106 may include the step of drawing the target portion 10A of the pericardium 10 proximal to the tip portion 110 and bringing it into contact with the penetrating element 106. After bringing the target portion 10A of the pericardium 10 into contact with the penetrating element 106, the opening may be enlarged. The step of enlarging the opening may include moving the end effector 104 of the pericardiotomy device 100 laterally relative to the pericardium 10, thereby laterally cutting the pericardium 10 with the penetrating element 106. The enlargement operation may be performed while a vacuum is maintained at the tip portion 110. 【0063】 In some embodiments, the penetrating element 206 may be repositionable longitudinally and / or radially relative to the tip portion 210. The step of bringing the target portion 10A of the pericardium 10 into contact with the penetrating element 206 may include moving the penetrating element 206 distal to the tip portion 210 to penetrate the target portion 10A of the pericardium 10. The step of moving the penetrating element 206 distal to the tip portion 210 to penetrate the target portion 10A of the pericardium 10 may include releasing the penetrating element 206 from a proximal retracted position and moving it to a distal extended position. Before moving the penetrating element 206 distal to the tip portion 210, the penetrating element 206 may be moved proximal from the extended position to a retracted position, and the penetrating element 206 may be held in the retracted position. The step of moving the penetrating element 206 distal to the tip portion 210 may include operating the needle release actuator 256. Before moving the through-element 206 distal to the tip portion 210, the needle depth actuator 258 may be operated to adjust the longitudinal position of the through-element 206 in the extended position. 【0064】 In some embodiments, the penetrating element 306 is rotatable longitudinally with respect to the tip portion 310. The step of bringing the target portion 10A of the pericardium 10 into contact with the penetrating element 306 may include the step of rotating the penetrating element 306 longitudinally with respect to the tip portion 310 to penetrate the target portion 10A of the pericardium 10. The step of rotating the penetrating element 306 with respect to the tip portion 310 to penetrate the target portion 10A of the pericardium 10 may include the step of rotating the penetrating element 306 longitudinally from a proximal retracted position to a distal extended position. The penetrating element 306 may include a curved needle 306. The step of rotating the penetrating element 306 with respect to the tip portion 310 to penetrate the target portion 10A of the pericardium 10 may include the step of rotating the curved needle 306 around 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 operating a needle rotation actuator 354 located on the handle portion 350 of the pericardiotomy device 300. 【0065】 A method for creating an opening through the pericardium 10 may include the step of engaging the openings 112, 212, 312 of the tip portions 110, 210, 310 of the end effectors 104, 204, 304 of the pericardiotomy devices 100, 200, 300 with the pericardium 10. The end effectors 104, 204, 304 may include the tip portions 110, 210, 310 and at least one penetrating element 106, 206, 306 positioned adjacent to the tip portions 110, 210, 310. By applying a vacuum to the tip portions 110, 210, 310, the target portion 10A of the pericardium 10 can be separated from the heart 12. By penetrating the target portion 10A of the pericardium 10 with the penetrating element 106, 206, 306, an opening through the target portion 10A of the pericardium 10 can be created. 【0066】 In some embodiments, the penetrating element 106 may include a fixed penetrating element 106 positioned in a fixed position relative to the tip portion 110. The step of penetrating the target portion 10A of the pericardium 10 with the penetrating element 106 may include using a vacuum to pull the target portion 10A of the pericardium 10 into the tip portion 110 of the end effector 104 and bring it into contact with the fixed penetrating 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. The step of penetrating the target portion 10A of the pericardium 10 with the penetrating element 206 may include the step of releasing the distally movable penetrating element 206 from a proximal retracted position to a distally extended position. 【0068】 In some embodiments, the penetrating element 306 includes a rotatable penetrating element 306. The step of penetrating the target portion 10A of the pericardium 10 with the penetrating element 306 may include the step of rotating the penetrating element 306 from a proximal retracted position to a distal extended position. 【0069】 A method for engaging the tissue may include the step of repositioning the end effector 304 in close proximity to the tissue surface 10. The through-body 306 may be rotated longitudinally from a retracted position not in contact with the tissue surface 10 to an engaged position in contact with the tissue surface 10 and extending into the tissue surface 10. To tension the tissue 10, the end effector 304 may be repositioned in the opposite direction from the tissue surface 10. 【0070】 In some embodiments, the perforator 306 may be further rotated longitudinally from the engagement position to the puncture position, where the perforator 306 punctures the tissue 10. When the end effector 304 is in close proximity to the tissue surface 10, a vacuum may be applied to the end effector 304. The step of repositioning the end effector 304 in close proximity to the tissue surface 10 may include the step of positioning the end effector 304 so as to form a seal between the end effector 304 and the tissue surface 10. 【0071】 Unless otherwise indicated, any description of structure, function, and / or methodology relating to any exemplary embodiment herein will be understood to apply to any other exemplary embodiment. More generally, it is within the scope of this disclosure to utilize any one or more features of any one or more examples of any one or more embodiments described herein in relation to any one or more features of any one or more other embodiments described herein. Accordingly, any combination of any features or embodiments described herein is within the scope of this disclosure. 【0072】 From the above description and summary of the invention, it should be apparent to those skilled in the art that the methods and apparatus described herein constitute examples of embodiments provided herein, but the scope of disclosure contained herein is not limited to the exact embodiments described above, and that modifications may be made without departing from the scope defined by the following claims. Similarly, it should be understood that it is not necessary to satisfy any or all of the specified advantages or objectives disclosed herein in order to fall within the scope of the claims, as there may be inherent and / or unexpected advantages that are not expressly discussed herein.

Claims

[Claim 1] A pericardiotomy device configured to create an opening through the pericardium, A long, slender shaft, An end effector positioned distally on the shaft, A tip portion including a tip opening configured to engage with a target portion of the pericardium, wherein the tip portion is configured to separate the target portion of the pericardium from the surface beneath the pericardium in the heart when a vacuum is applied to the tip portion, Within the tip portion, there is at least one penetrating element positioned to rotate along an arc-shaped trajectory around the axle, and configured to rotate to create an opening that penetrates the target portion of the pericardium when a vacuum is applied to the tip portion, and The end effector comprising A pericardiotomy device equipped with the following features. [Claim 2] The aforementioned tip opening includes the distal tip opening, The pericardiotomy device according to claim 1, wherein the at least one penetrating element is retracted proximally with respect to the distal tip opening within the tip portion. [Claim 3] The at least one penetrating element includes a generally triangular blade, The pericardiotomy device according to claim 2, wherein the blade is oriented generally in the diametrical direction within the tip portion, and the blade has a distally pointed tip. [Claim 4] The pericardiotomy device according to claim 3, wherein the blade comprises at least one obliquely oriented cutting edge. [Claim 5] The pericardiotomy device according to claim 4, further comprising an externally visible mark indicating the orientation of the cutting edge of the blade. [Claim 6] The pericardiotomy device according to claim 1, wherein the at least one penetrating element includes a needle. [Claim 7] The shaft further comprises a handle positioned near the shaft, The pericardiotomy device according to claim 6, wherein the handle comprises a needle release actuator that can be operated to release the needle from a proximal retracted position to a distal extended position. [Claim 8] The pericardiotomy device according to claim 7, wherein the handle comprises a needle retraction actuator that can be operated to move the needle from the extended position to the retracted position. [Claim 9] The pericardiotomy device according to claim 7, wherein the handle comprises a needle depth actuator that is operable for adjusting the longitudinal position of the extended position of the needle. [Claim 10] The pericardiotomy device according to claim 6, wherein the needle includes a hollow needle. [Claim 11] The shaft further comprises a handle positioned near the shaft, The pericardiotomy device according to claim 6, wherein the handle comprises a needle rotation actuator that can be operated to rotate the needle from a retracted proximal position to a distal extended position. [Claim 12] The end effector is equipped with a needle operating mechanism, The needle operating mechanism includes a needle mount rotatably positioned on the axle, The needle is positioned on the needle mount, The pericardiotomy device according to claim 11, further comprising a linkage that operatively connects the needle rotation actuator and the needle operating mechanism. [Claim 13] The pericardiotomy device according to claim 6, wherein the needle includes a curved needle. [Claim 14] The pericardiotomy device according to claim 1, wherein the tip portion is formed in a bell shape such that the proximal end of the tip portion has an outer diameter substantially the same as the outer diameter of the shaft, and the distal end of the tip portion has an outer diameter larger than the outer diameter of the shaft. [Claim 15] The pericardiotomy device according to claim 14, wherein the outer diameter of the distal end of the tip portion is approximately twice the outer diameter of the shaft. [Claim 16] The pericardiotomy device according to claim 1, further comprising at least one vacuum connector configured to be fluidly coupled to the tip portion and to be fluidly coupled to a vacuum source. [Claim 17] A pericardiotomy device configured to create an opening through the pericardium, A long, slender shaft, An end effector positioned distally on the shaft, A tip portion including an opening configured to engage with the target portion of the pericardium, wherein the tip portion is configured to separate the target portion of the pericardium from the outer surface of the heart when a vacuum is applied to the tip portion, The at least one penetrating element positioned within the tip portion acts to create an opening in the target portion of the pericardium when a vacuum is applied to the tip portion. The end effector comprising, The shaft comprises a handle positioned near the shaft, The at least one penetrating element includes a needle, The at least one through element is arranged to be rotatably movable relative to the tip portion, The handle comprises (i) a needle rotation actuator that can be operated to rotate the needle from a retracted proximal position to a distal extended position, and (ii) a needle depth actuator that can be operated to adjust the longitudinal position of the needle. Pericardiotomy device. [Claim 18] The aforementioned needle includes a generally triangular blade, The pericardiotomy device according to claim 17, wherein the blade is oriented generally in the diametrical direction within the tip portion, and the blade has a distally pointed tip. [Claim 19] The pericardiotomy device according to claim 18, wherein the blade comprises at least one obliquely oriented cutting edge. [Claim 20] The pericardiotomy device according to claim 19, further comprising an externally visible mark indicating the orientation of the cutting edge of the blade. [Claim 21] The pericardiotomy device according to claim 17, wherein the handle comprises a needle release actuator that can be operated to release the needle from a proximal retracted position to a distal extended position. [Claim 22] The pericardiotomy device according to claim 21, wherein the handle comprises a needle retraction actuator that can be operated to move the needle from the extended position to the retracted position. [Claim 23] The pericardiotomy device according to claim 21, wherein the handle comprises a needle depth actuator that is operable for adjusting the longitudinal position of the extended position of the needle. [Claim 24] The pericardiotomy device according to claim 17, wherein the needle includes a curved needle. [Claim 25] The pericardiotomy device according to claim 17, wherein the tip portion is formed in a bell shape such that the proximal end of the tip portion has an outer diameter substantially the same as the outer diameter of the shaft, and the distal end of the tip portion has an outer diameter larger than the outer diameter of the shaft. [Claim 26] The pericardiotomy device according to claim 25, wherein the outer diameter of the distal end of the tip portion is approximately twice the outer diameter of the shaft. [Claim 27] The pericardiotomy device according to claim 17, further comprising at least one vacuum connector configured to be fluidly coupled to the tip portion and to be fluidly coupled to a vacuum source.

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