Non-penetrating tissue separator

Abstract

The present invention relates to devices and methods for separating tissue to create an anatomical access space in vivo, particularly for providing access to the space between the pericardium and the epicardium.

Description

Technical Field

[0001] The present invention relates to devices and methods for separating tissue to create an anatomical access space in vivo, and in particular for providing access to the space between the pericardium and the epicardium. Background Art

[0002] The access to the internal and external structures of the heart may be desirable for treating cardiovascular diseases. One way to access the heart for device delivery is through an intravascular method. However, the intravascular access to the heart may not be suitable for delivering larger devices, nor for situations where the external structures of the heart are targeted. In this case, the heart can be accessed through an opening or perforation in the pericardium, which can provide a direct access to the outer (epicardial) surface of the heart. For this reason, it is desirable to provide sufficient and safer access to the space between the pericardium and the epicardium (referred to as the pericardial space), through which surgical tools, drugs and other medical devices can be passed, such as on a guidewire, to perform a surgical operation, or independently operated without a guidewire. Such a surgical operation can include device delivery (such as coronary artery bypass grafting), drug delivery, left atrial appendage treatment, fibrotic tissue ablation, treatment of arrhythmias, placement of ECG leads or other sensors, reduction of bleeding by pressure application, pericardial drainage (pericardial puncture), gene therapy, etc.

[0003] The space between the pericardial tissue and the epicardial tissue, called the pericardial space, is in most cases only a potential space filled with pericardial fluid. U.S. Application Publication No. 2012 / 238968 discloses a device configured to engage and penetrate the pericardial sac via a helical tissue spring that can rotate about its axis and has a distal tip configured to be screwed into the pericardial sac. U.S. Application Publication No. 2015 / 065898 discloses an instrument for differentially dissecting complex tissues, the instrument being provided with a dissecting wheel having protrusions that are configured to tear apart individual fiber components in order to dissect and penetrate the tissue into the pericardial sac. Therefore, there is a need in the art for a safe and easy-to-use device and method that achieves separation between the pericardial layer and the epicardial layer to create a passage space with sufficient volume and safe passage, preferably without cutting or penetrating the epicardium or myocardium, thereby avoiding potential damage to the heart. Summary of the invention

[0004] The following embodiments and aspects of these embodiments are described and illustrated in conjunction with systems, apparatus and methods that are intended to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments involve other advantages or improvements.

[0005] According to some embodiments, devices and methods are provided for separating between tissue layers (such as the pericardium and the epicardium) to provide an access space between the tissue layers. The device generally includes an outer shaft and an inner shaft that are axially movable relative to each other, wherein the inner shaft is attached to a grasping element at its distal edge.

[0006] The grasping element is equipped with surface features that are configured to contact and engage tissue (such as the pericardium), thereby facilitating the engagement of the tissue around the grasping element to wind around the grasping element when rotating about the central axis of the grasping element. Then, the device can be manipulated to retract the grasping element together with the wound tissue, thereby creating an access space between the grasped pericardial tissue and the epicardium.

[0007] Advantageously, the grasping element, which is configured as a non-damaging element, engages, winds, and retracts the pericardium without cutting or penetrating the pericardium. For example, the surface features and all edges of the grasping element can be blunt to avoid undesired damage to the pericardial tissue during winding or retracting the pericardial tissue to create a working space.

[0008] According to one aspect, a non-penetrating tissue separator is provided, which includes an outer shaft, an inner shaft having an inner shaft lumen, and a grasping element attached to the distal edge of the inner shaft.

[0009] The outer shaft includes an outer shaft lumen, an outer shaft distal portion, and an outer shaft distal lip.

[0010] The grasping element includes a grasping element distal surface, a grasping element circumferential surface, a grasping element inner opening, and surface features provided along at least one of the grasping element distal surface and the grasping element circumferential surface.

[0011] At least a portion of the outer shaft is disposed around at least a portion of the inner shaft to enable relative axial movement between the inner shaft and the outer shaft, thereby facilitating the positioning of the grasping element between a first state and a second state.

[0012] The grasping element is rotatable about the central axis of the grasping element, wherein the central axis of the grasping element is oriented in a distally oriented direction and is orthogonal to the grasping element distal surface.

[0013] The surface features are non-damaging surface features that are configured to releasably engage and grasp tissue via the surface features during rotational movement of the grasping element about the central axis of the grasping element without cutting, slicing, or penetrating the tissue, and to hold the engaged tissue after the rotational movement stops.

[0014] According to another aspect, a non-penetrating tissue separator is provided, which includes an outer shaft, an inner shaft having an inner shaft lumen, and a grasping element attached to the distal edge of the inner shaft.

[0015] The outer shaft includes an outer shaft lumen, a distal portion of the outer shaft, and a distal lip of the outer shaft.

[0016] The grasping element includes a distal surface of the grasping element, a proximal surface of the grasping element, a circumferential surface of the grasping element, an inner opening of the grasping element, and surface features disposed along at least one of the distal surface of the grasping element, the proximal surface of the grasping element, or the circumferential surface of the grasping element.

[0017] At least a portion of the outer shaft is disposed around at least a portion of the inner shaft to enable relative axial movement between the inner shaft and the outer shaft, thereby facilitating positioning of the grasping element between a first state and a second state.

[0018] The grasping element is rotatable about a central axis of the grasping element, wherein the central axis of the grasping element is oriented in a distally directed direction and is orthogonal to the distal surface of the grasping element.

[0019] The surface features are atraumatic surface features configured to releasably engage and grasp tissue via the surface features during rotational movement of the grasping element about the central axis of the grasping element without cutting, slicing, or penetrating the tissue and to hold the tissue engaged therewith after the rotational movement stops.

[0020] According to some embodiments, the non-penetrating tissue dissector further includes a handle attached to at least one of the inner shaft and the outer shaft, wherein the handle is configured to facilitate relative axial movement between the inner shaft and the outer shaft and wherein the handle is configured to facilitate rotation of the grasping element.

[0021] According to some embodiments, the handle further includes a steering knob that engages the inner shaft and is configured to facilitate at least one of axial movement or rotational movement of the inner shaft.

[0022] According to some embodiments, the steering knob is configured to rotate about a central axis of the steering knob and wherein the inner shaft is threadedly engaged with the steering knob.

[0023] According to some embodiments, the handle further includes a first handle recess, wherein the steering knob is disposed within the first handle recess.

[0024] According to some embodiments, the steering knob includes a steering knob inner bore configured to receive the inner shaft extending therethrough such that the inner shaft is configured to axially move through the steering knob inner bore.

[0025] According to some embodiments, the inner shaft is configured to act axially within the steering knob inner bore via a roller bearing attached to the inner shaft.

[0026] According to some embodiments, the handle further includes a second handle recess configured to visually expose at least a portion of the inner shaft extending through the second handle recess.

[0027] According to some embodiments, the non-penetrating tissue dissector further includes a first shaft spring disposed between the inner shaft and the handle, the first shaft spring being configured to provide resistance to proximal displacement of the inner shaft.

[0028] According to some embodiments, the non-penetrating tissue dissector further includes a second shaft spring disposed between the inner shaft and the handle, the second shaft spring being configured to provide resistance to distal displacement of the inner shaft.

[0029] According to some embodiments, the non-penetrating tissue dissector further includes a marker for indicating at least one of the following: the position of the grasping element, the force exerted by the grasping element when pressed against the outer surface, whether the tissue provides resistance to proximal pulling of the grasping element, or whether the tissue has been grasped by the grasping element.

[0030] According to some embodiments, the inner shaft includes a structural feature or a marker that can be compared with the marker.

[0031] According to some embodiments, the non-penetrating tissue dissector further includes a lid configured to at least cover the second handle recess.

[0032] According to some embodiments, the non-penetrating tissue dissector further includes a latching mechanism including a rod pivotally movable about a pivot of a rod support body and a grooved element including at least two axially spaced grooves, wherein the rod support body is fixedly attached to the outer shaft, and wherein each groove is configured to receive an end portion of the rod, and wherein the grooved element is fixedly attached to the handle.

[0033] According to some embodiments, the latching mechanism further includes a knob connected to an end of the rod and a knob spring disposed between the knob and the rod support body.

[0034] According to some embodiments, relative axial movement between the inner shaft and the outer shaft is facilitated by a threaded engagement between the inner shaft and the outer shaft.

[0035] According to some embodiments, relative axial movement between the inner shaft and the outer shaft is facilitated by a threaded engagement between the inner shaft and the handle.

[0036] According to some embodiments, the outer diameter of the grasping element is smaller than the diameter of the outer shaft lumen such that the grasping element is configured to be inserted into the outer shaft lumen.

[0037] According to some embodiments, the non-penetrating tissue separator further includes an inner shaft retraction limiting mechanism configured to limit the maximum retraction of the grasping element in the proximal direction.

[0038] According to some embodiments, the outer shaft lumen includes a distal tapered portion of the outer shaft that tapers radially inward in the proximal direction from the distal lip of the outer shaft.

[0039] According to some embodiments, the outer shaft lumen includes a distal slot of the outer shaft that extends between the distal lip of the outer shaft and the distal slot shoulder of the outer shaft.

[0040] According to some embodiments, the non-penetrating tissue separator further includes a vertebral head attached to the distal portion of the outer shaft and having a distal lip of the vertebral head that defines an opening of the vertebral head.

[0041] According to some embodiments, the vertebral head further includes a plurality of wings configured to switch between a non-expanded state and an expanded state.

[0042] According to some embodiments, the wings are spring-biased radially inwardly, and wherein the wings are configured to radially expand outwardly due to an internal thrust applied to the inner surface of the vertebra during axial movement of the grasping element along the inner surface of the vertebra.

[0043] According to some embodiments, the vertebral head is threadedly engaged with the grasping element, and wherein the plurality of wings are configured to radially expand outwardly to an expanded state when the grasping element is threadedly transferred from a first state to a second state.

[0044] According to some embodiments, the vertebral head is formed as a rigid non-deformable structure.

[0045] According to some embodiments, the vertebral head is formed as at least one helical coil having a plurality of spaced-apart turns.

[0046] According to some embodiments, the non-penetrating tissue separator further includes a delivery shaft disposed around at least a portion of the outer shaft to enable relative axial movement between the outer shaft and the delivery shaft.

[0047] According to some embodiments, the vertebral head is configured to tilt relative to the outer shaft to transition between a non-tilted vertebral state and a tilted vertebral state.

[0048] According to some embodiments, the vertebral head is pivotally attached to the outer shaft.

[0049] According to some embodiments, at least a portion of the vertebral head includes at least one of a flexible material or a shape memory material.

[0050] According to some embodiments, the grasping element is disc-shaped such that the axial length of the grasping element is shorter than the outer diameter of the grasping element.

[0051] According to some embodiments, the grasping element is elongate such that the axial length of the grasping element is equal to or longer than the outer diameter of the grasping element.

[0052] According to some embodiments, the inner shaft includes a bendable inner shaft portion and a rigid inner shaft portion such that the distal end of the inner shaft is configured to bend relative to the outer shaft.

[0053] According to some embodiments, the bendable inner shaft portion includes a material that is more flexible than the material of the rigid inner shaft portion.

[0054] According to some embodiments, the bendable inner shaft portion includes a spring.

[0055] According to some embodiments, the bendable inner shaft portion includes slots or bellows that render the bendable inner shaft portion flexible.

[0056] According to some embodiments, the inner shaft further includes an inner shaft threaded portion that extends proximally from the connection interface of the inner shaft and the grasping element.

[0057] According to some embodiments, the non-penetrating tissue separator further includes at least one optical sensor.

[0058] According to some embodiments, the non-penetrating tissue separator further includes at least one ECG electrode.

[0059] According to another aspect of the present invention, there is provided a kit that includes a non-penetrating tissue separator according to any one of the foregoing embodiments, and a passage device that is capable of passing through the inner shaft lumen and through the inner opening of the grasping element and is configured to pierce, cut, or penetrate the pericardium.

[0060] According to some embodiments, the passage device is a needle that includes a distal needle portion.

[0061] According to some embodiments, the needle further includes a needle limiting element that is configured to limit the penetration depth of the needle.

[0062] According to some embodiments, the distal needle portion is curved.

[0063] According to some embodiments, the passage device includes a threaded portion having a circumferentially oriented sharp end that is configured to pierce or penetrate the pericardium from a lateral direction during rotation of the threaded portion.

[0064] According to some embodiments, the kit further includes a guide wire.

[0065] In another aspect of the present invention, there is provided a kit, which includes a non-penetrating tissue separator according to any one of the foregoing embodiments, and a balloon catheter configured to inflate a balloon distal to the non-penetrating tissue separator.

[0066] In yet another aspect of the present invention, there is provided a method of using a non-penetrating tissue separator, the method comprising the steps of:

[0067] providing a non-penetrating tissue separator according to any one of the foregoing embodiments,

[0068] while the grasping element is in a first state, advancing the distal portion of the non-penetrating tissue separator in a distal direction,

[0069] manipulating the non-penetrating tissue separator to move the grasping element from the first state to a second state,

[0070] manipulating the non-penetrating tissue separator to rotate the grasping element, and

[0071] manipulating the non-penetrating tissue separator to pull the grasping element in a proximal direction.

[0072] In yet another aspect of the present invention, there is provided a method of using a non-penetrating tissue separator, the method comprising the steps of:

[0073] providing a non-penetrating tissue separator according to any one of the foregoing embodiments,

[0074] while the grasping element is in the second state, advancing the distal portion of the non-penetrating tissue separator in a distal direction,

[0075] manipulating the non-penetrating tissue separator to rotate the grasping element, and

[0076] manipulating the non-penetrating tissue separator to pull the grasping element in a proximal direction.

[0077] Certain embodiments of the present invention may include some or all of the above advantages or may not include any of the above advantages. Those skilled in the art can readily appreciate further advantages from the drawings, the description, and the claims included herein. Aspects and embodiments of the present invention are further described in the following description and the appended claims herein.

[0078] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the present patent specification, including definitions, will control. As used herein, the indefinite article "a" means "at least one" or "one or more", unless the context clearly dictates otherwise.

[0079] The following embodiments and aspects of these embodiments are described and illustrated in connection with systems, tools, and methods that are intended to be exemplary and illustrative, without limiting the scope. In various embodiments, one or more of the above problems have been reduced or eliminated, while other embodiments relate to other advantages or improvements. BRIEF DESCRIPTION OF THE DRAWINGS

[0080] Some embodiments of the present invention are described herein with reference to the accompanying drawings. This description, together with the drawings, enables one of ordinary skill in the art to understand how some embodiments may be implemented. The drawings are for the purpose of illustrative description and are not intended to show structural details of the embodiments in more detail than is necessary for a basic understanding of the present invention. For clarity, some of the objects depicted in the drawings are not drawn to scale.

[0081] In the drawings:

[0082] Figure 1A A perspective view of a non-penetrating tissue separator according to some embodiments.

[0083] Figure 1B Comprising Figure 1A A cross-sectional side view of the non-penetrating tissue separator.

[0084] Figure 1C Comprising in a first state Figure 1A A perspective enlarged cross-sectional view of the distal region of the non-penetrating tissue separator.

[0085] Figure 1D Comprising Figure 1A A perspective enlarged cross-sectional view of the distal region of the non-penetrating tissue separator, where the wings of the vertebral head are expanded.

[0086] Figure 1E Comprising in a second state Figure 1A A perspective enlarged cross-sectional view of the distal region of the non-penetrating tissue separator.

[0087] Figure 1F Comprising Figure 1A An enlarged cross-sectional side view of the distal region of the non-penetrating tissue separator.

[0088] Figures 2A to 2FPerspective views of different embodiments of the grasping element.

[0089] Figures 3A to 3E Illustrates different steps of a method of using a non-penetrating tissue separator according to some embodiments.

[0090] Figure 4A Perspective view of a non-penetrating tissue separator according to some embodiments.

[0091] Figure 4B Comprising Figure 4A Cross-sectional side view of the non-penetrating tissue separator of.

[0092] Figures 5A to 5D Illustrates different steps of a method of using a non-penetrating tissue separator according to some embodiments.

[0093] Figures 6A to 6B Magnified cross-sectional side view of different steps of separation between anatomical heart tissues according to some embodiments.

[0094] Figure 7A Magnified perspective view of the distal region of a non-penetrating tissue separator without a vertebral head according to some embodiments.

[0095] Figure 7B Comprising in a first state Figure 7A Cross-sectional side view of the distal region of the non-penetrating tissue separator of.

[0096] Figure 7C Comprising in a second state Figure 7A Cross-sectional side view of the distal region of the non-penetrating tissue separator of.

[0097] Figure 8A Cross-sectional side view of the distal region of a non-penetrating tissue separator without a vertebral head in a first state according to some embodiments.

[0098] Figure 8B Comprising in a second state Figure 8A Cross-sectional side view of the distal region of the non-penetrating tissue separator of.

[0099] Figure 9A Magnified perspective view of the distal region of a non-penetrating tissue separator without a vertebral head according to some embodiments.

[0100] Figure 9B Comprising in a first state Figure 9A Cross-sectional side view of the distal region of the non-penetrating tissue separator of.

[0101] Figure 9C Comprising in a second stateFigure 9A Cross-sectional side view of the distal region of a non-penetrating tissue separator.

[0102] Figures 10A to 10C Illustrates different steps of a method of using a non-penetrating tissue separator according to some embodiments.

[0103] Figure 11A Cross-sectional side view of a non-penetrating tissue separator in a first state according to some embodiments.

[0104] Figure 11B Comprises a cross-sectional side view of a non-penetrating tissue separator in a second state Figure 11A of.

[0105] Figure 12A Cross-sectional side view of a non-penetrating tissue separator in a first state according to some embodiments.

[0106] Figure 12B Comprises a cross-sectional side view of a non-penetrating tissue separator in a second state Figure 12A of.

[0107] Figure 13A Cross-sectional side view of a non-penetrating tissue separator in a first state according to some embodiments.

[0108] Figure 13B Comprises a cross-sectional side view of a non-penetrating tissue separator in a second state Figure 13A of.

[0109] Figure 14A Cross-sectional side view of a non-penetrating tissue separator in a first state according to some embodiments.

[0110] Figure 14B Comprises a cross-sectional side view of a non-penetrating tissue separator in a second state Figure 14A of.

[0111] Figure 15 Perspective view of a grasping element according to some embodiments.

[0112] Figure 16A Cross-sectional side view of the distal region of a non-penetrating tissue separator in a first state according to some embodiments.

[0113] Figure 16B Comprises a cross-sectional side view of a non-penetrating tissue separator in a second state Figure 16A of the distal region of.

[0114] Figure 17ACross-sectional side view of the distal region of a non-penetrating tissue separator in a first state according to some embodiments.

[0115] Figure 17B Cross-sectional side view of the distal region of a non-penetrating tissue separator in a second state Figure 17A of.

[0116] Figure 18A Cross-sectional side view of the distal region of a non-penetrating tissue separator in a first state according to some embodiments.

[0117] Figure 18B Cross-sectional side view of the distal region of a non-penetrating tissue separator in a second state Figure 18A of.

[0118] Figures 19A to 19C Illustrates different steps of a method of using a non-penetrating tissue separator according to some embodiments.

[0119] Figure 20A Cross-sectional side view of the distal region of a non-penetrating tissue separator in a first state according to some embodiments.

[0120] Figure 20B Cross-sectional side view of the distal region of a non-penetrating tissue separator in a second state Figure 20A of.

[0121] Figures 21A to 21C Illustrates different steps of a method of using a non-penetrating tissue separator according to some embodiments.

[0122] Figure 22A Perspective view of a non-penetrating tissue separator according to some embodiments.

[0123] Figure 22B Cross-sectional side view of a non-penetrating tissue separator in a first state Figure 22A of.

[0124] Figure 22C Cross-sectional side view of a non-penetrating tissue separator in a second state Figure 22A of.

[0125] Figure 23A Perspective view of a non-penetrating tissue separator according to some embodiments.

[0126] Figure 23B Cross-sectional side view of a non-penetrating tissue separator in a first state Figure 22A of.

[0127] Figure 23CA cross-sectional side view of a non-penetrating tissue separator configured in a second state. Figure 23A

[0128] Figure 24A A perspective view of an inner shaft having a roller bearing according to some embodiments.

[0129] Figure 24B Configured Figure 24A A cross-sectional view of the inner shaft taken along direction 24B-24B.

[0130] Figure 25 Configured Figure 23C A cross-sectional view of the non-penetrating tissue separator taken along direction 25-25.

[0131] Figure 26A A perspective view of a balloon catheter having an inflated balloon distal to a non-penetrating tissue separator according to some embodiments.

[0132] Figure 26B Configured Figure 26A A cross-sectional side view of the balloon catheter.

[0133] Figures 27A to 27D Illustrates different steps of a method of using a non-penetrating tissue separator according to some embodiments.

[0134] Figure 28A A perspective view of a non-penetrating tissue separator according to some embodiments.

[0135] Figure 28B A cross-sectional side view of a non-penetrating tissue separator configured in a first state. Figure 28A

[0136] Figure 28C A cross-sectional side view of a non-penetrating tissue separator configured in a second state. Figure 28A

[0137] Figure 29A A cross-sectional side view of a distal portion of a non-penetrating tissue separator equipped with a tiltable vertebral head in a non-tilted vertebral state according to some embodiments.

[0138] Figure 29B A cross-sectional side view of a distal portion of a non-penetrating tissue separator equipped with a tiltable vertebral head in a tilted vertebral state according to some embodiments.

[0139] Figure 30 A cross-sectional side view of a distal portion of a non-penetrating tissue separator equipped with a flexible inner shaft according to some embodiments.

[0140] Figure 31Cross-sectional side view of the distal portion of a non-penetrating tissue separator equipped with a bendable inner shaft according to some embodiments.

[0141] Figure 32 Cross-sectional side view of the distal portion of a non-penetrating tissue separator equipped with a bendable inner shaft according to some embodiments.

[0142] Figure 33A Cross-sectional side view of the distal portion of a non-penetrating tissue separator equipped with a bendable inner shaft in an unbent shaft state according to some embodiments.

[0143] Figure 33B Cross-sectional side view of the distal portion of a non-penetrating tissue separator equipped with a bendable inner shaft in a bent shaft state according to some embodiments.

[0144] Figure 34A Cross-sectional side view of the distal portion of a non-penetrating tissue separator equipped with a spring coil vertebral head retained within a delivery shaft according to some embodiments.

[0145] Figure 34B Cross-sectional side view of the distal portion of a non-penetrating tissue separator equipped with a spring coil vertebral head extending distally from the delivery shaft while in a first state according to some embodiments.

[0146] Figure 34C Cross-sectional side view of the distal portion of a non-penetrating tissue separator equipped with a spring coil vertebral head extending distally from the delivery shaft while in a second state according to some embodiments.

[0147] Figure 34D Constructed with Figure 34C Perspective view of the distal portion of a non-penetrating tissue separator with a spring coil vertebral head. Detailed Description

[0148] In the following description, various aspects of the present disclosure will be described. For purposes of illustration, specific configurations and details are set forth to provide a thorough understanding of the different aspects of the present disclosure. However, it will be apparent to those skilled in the art that the present disclosure may be practiced without the specific details presented herein. Additionally, well-known features may be omitted or simplified to avoid obscuring the present disclosure. In the drawings, the same reference numerals always refer to the same components.

[0149] In all of the figures of the drawings, different superscripts for the same reference numeral are used to denote different embodiments of the same element. Embodiments of the disclosed apparatus and system may include any combination of different embodiments of the same element. Specifically, any reference to an element without a superscript may refer to any alternative embodiment of the same element denoted with a superscript. To avoid excessive clutter caused by having too many reference numerals and leads on a particular figure, some components will be introduced via one or more figures without being explicitly identified in each subsequent figure that includes the component.

[0150] Now referring to Figures 1A to 1F . Figure 1A and Figure 1B constitute a perspective view and a cross-sectional side view of a non-penetrating tissue separator 100 according to some embodiments. The non-penetrating tissue separator 100 includes an outer shaft 120, an inner shaft 140 disposed within a lumen 132 of the outer shaft 120, and a grasping element 190 attached to a distal edge of the inner shaft 140.

[0151] The outer shaft 120 includes an outer shaft proximal portion 122, an outer shaft distal portion 124 having an outer shaft distal lip 126, an outer shaft outer surface 128, and an outer shaft inner surface 130 defining the outer shaft lumen 132. The inner shaft 140 includes an inner shaft proximal portion 142, an inner shaft distal portion 144, an inner shaft outer surface 148, and an inner shaft inner surface 150 defining the inner shaft lumen 152.

[0152] At least a portion of the outer shaft 120 is disposed concentrically about at least a portion of the inner shaft 140 such that at least one of the inner shaft 140 or the outer shaft 120 can move axially relative to the outer shaft 120 or the inner shaft 140, respectively, e.g., move axially relative to the outer shaft 120 or the inner shaft 140 in a telescoping manner.

[0153] According to some embodiments, the inner shaft 140 can move distally while the outer shaft 120 is stationary, thereby causing the grasping element 190 attached to the distal edge of the inner shaft 140 to move distally relative to the outer shaft distal lip 126. According to some embodiments, the outer shaft 120 can move proximally while the inner shaft 140 is stationary, thereby causing the outer shaft distal lip 126 to move proximally relative to the grasping element 190.

[0154] According to some embodiments, the inner shaft 140 can slide freely within the outer shaft lumen 132. According to some embodiments, the outer shaft 120 can slide freely on the inner shaft outer surface 148.

[0155] In the context of the present application, the term "distal" generally refers to the side or end of any device or component of a device that is closer to the heart tissue during use. More specifically, the distal end of the non-penetrating tissue separator 100 is the end that is closer to the pericardial surface 14, such as the end that is closer to the pericardial surface 14 along the grasping element 190.

[0156] In the context of the present application, the term "proximal" generally refers to the side or end of any device or component of a device that is opposite to the "distal end" and is farther from the heart tissue or closer to the operator of the non-penetrating tissue separator 100 during use.

[0157] The grasping element 190 is capable of rotating about a central axis of the grasping element 190, wherein the central axis of the grasping element 190 is oriented in a direction that is distal and orthogonal to the distal surface 196 of the grasping element. According to some embodiments, the inner shaft 140 is configured to rotate about a central axis of the inner shaft 140 within the outer shaft lumen 132. According to some embodiments, the grasping element 190 is attached to the distal end of the inner shaft 140 such that rotation of the inner shaft 140 causes the grasping element 190 to rotate in the same direction.

[0158] According to some embodiments, the non-penetrating tissue separator 100 further includes a handle 102. The handle 102 includes a proximal handle portion 104 and a distal handle portion 106. At least one of the inner shaft 140 and the outer shaft 120 is attached to the handle 102 such that the handle 102 is configured to facilitate relative axial movement between the inner shaft 140 and the outer shaft 120.

[0159] According to some embodiments, the inner shaft 140 is connected to the handle 102 such that the handle 102 is configured to facilitate relative axial movement between the inner shaft 140 and the outer shaft 120. According to some embodiments, the outer shaft 120 is connected to the handle 102.

[0160] The handle is also configured to facilitate rotation of the grasping element 190, such as by facilitating rotation of the inner shaft 140 to facilitate rotation of the grasping element 190.

[0161] According to some embodiments, at least a portion of the inner shaft 140 extends through at least a portion of the handle 102. According to some embodiments, the proximal inner shaft portion 142 extends through at least a portion of the handle 102. According to some embodiments, the handle includes a handle inlet 107. According to some embodiments, the distal handle portion 106 includes the handle inlet 107. According to some embodiments, the proximal inner shaft portion 142 is configured to extend through the handle inlet 107. According to some embodiments, the handle inlet 107 is configured to provide access to the inner shaft lumen 152.

[0162] According to some embodiments, the handle 102 further includes a first handle recess 108 disposed between the proximal portion 104 and the distal portion 106 of the handle (see Figures 1A to 1B ). According to some embodiments, the handle 102 further includes a steering knob 110. According to some embodiments, the steering knob 110 is attached to the inner shaft and is configured to facilitate axial movement of the inner shaft 140 in the distal and proximal directions.

[0163] According to some embodiments, the steering knob 110 is disposed within the handle recess 108. According to some embodiments, the steering knob 110 is formed as a steering wheel configured to rotate about a central axis of the steering knob 110. According to some embodiments, the steering knob 110 includes a steering knob bore 112 sized to receive the inner shaft 140 extending therethrough.

[0164] According to some embodiments, the inner shaft 140 engages the steering knob 110 such that the inner shaft 140 is movably or fixedly connected to the steering knob 110, or alternatively, is held via direct or indirect contact with the steering knob 110.

[0165] According to some embodiments, the inner shaft 140 is connected to the steering knob bore 112. According to some embodiments, the steering knob bore 112 includes a steering knob thread portion 114, and a portion of the outer surface of the inner shaft 148 includes a matching inner shaft thread portion 154 such that the inner shaft 140 is threadedly engaged with the steering knob 110. In such an embodiment, rotation of the steering knob 110 in one direction can cause the inner shaft 140 to axially translate in the distal direction 92 relative to the handle 102, thereby causing the position of the grasping element 190 to translate distally along the direction 92 (see Figure 1E ).

[0166] According to some embodiments, the number and pitch of the threads of the steering knob thread portion 114, and thus the matching threads of the inner shaft thread portion 154, and the axial lengths of the steering knob thread portion 114 and / or the inner shaft thread portion 154 can be selected to provide a desired degree of travel for the grasping element 190.

[0167] According to some embodiments, the outer shaft 120 is connected to the handle 102. According to some embodiments, the outer shaft 120 is fixedly attached to the handle 102. According to some embodiments, the outer shaft 120 is immovable or stationary relative to the handle 120. According to some embodiments, the proximal portion 122 of the outer shaft is fixedly attached to the distal portion 106 of the handle, for example, by gluing, welding, etc.

[0168] Now refer to Figures 1C to 1F , Figures 1C to 1FAn enlarged view of the distal region of the non-penetrating tissue separator 100 in different states according to some embodiments. According to some embodiments, the non-penetrating tissue separator 100 further includes a vertebral head 160 attached to the distal portion 124 of the outer shaft. The vertebral head 160 includes a proximal vertebral portion 164 connected to the distal portion 124 of the outer shaft, a distal vertebral portion 166 having a distal vertebral lip 174, and an inner vertebral surface 178. The distal vertebral lip 174 defines a vertebral opening 168. According to some embodiments, the vertebral head 160 is attached to the outer shaft 120 such that the distal vertebral lip 174 is positioned distal to the distal portion 124 of the outer shaft.

[0169] The distal outer edge of the non-penetrating tissue separator 100 is defined as the farthest distal edge between the distal lip 126 of the outer shaft and the distal vertebral lip 174. For example, if the non-penetrating tissue separator 100 does not include the vertebral head 160, the distal lip 126 of the outer shaft can be used as the distal outer edge. Alternatively, for embodiments including a vertebral head 160 attached to the distal portion 124 of the outer shaft, the distal vertebral lip 174 can be used as the distal outer edge.

[0170] According to some embodiments, the non-penetrating tissue separator 100 is capable of moving between a first state and a second state. The first state of the non-penetrating tissue separator 100 is defined as the state in which the distal surface 196 of the grasping element 190 is positioned close to or flush with the distal outer edge, and the second state of the non-penetrating tissue separator 100 is defined as the state in which the distal surface 196 of the grasping element 190 is positioned distal to the distal outer edge. According to some embodiments, the second state is further defined as the state in which the proximal surface 194 of the grasping element 190 is spaced distally from the plane defined by the distal outer edge.

[0171] Any reference throughout the specification to the non-penetrating tissue separator 100 capable of moving between a first state and a second state is equivalent to the grasping element 190 capable of moving between a first state and a second state.

[0172] At least a portion of the outer shaft 140 is disposed around at least a portion of the inner shaft 120 to enable relative axial movement between the inner shaft 120 and the outer shaft 140, thereby moving the grasping element 190 in a distal or proximal direction relative to the distal lip 126 of the outer shaft.

[0173] At least a portion of the outer shaft 140 is disposed around at least a portion of the inner shaft 120 to enable relative axial movement between the inner shaft 120 and the outer shaft 140, thereby transitioning the grasping element 190 between the first state and the second state, or between any state between the first state and the second state.

[0174] According to some embodiments, at least a portion of the outer shaft 140 is disposed concentrically about at least a portion of the inner shaft 120. According to some embodiments, the outer shaft 140 and the inner shaft 120 are coaxial.

[0175] According to some embodiments, the inner shaft 120 and the outer shaft 140 are configured to slide axially relative to each other by pushing the inner shaft 120 in the distal direction relative to the outer shaft 140.

[0176] According to some embodiments, the inner shaft 120 and the outer shaft 140 are configured to slide axially relative to each other by pulling or retracting the outer shaft 140 in the proximal direction relative to the inner shaft 120.

[0177] According to some embodiments, the handle 102 can be manipulated by an operator to transition the non-penetrating tissue separator 100 between a first state and a second state - including states between the first state and the second state. According to some embodiments, the internal threads of the steering knob thread portion 114 are configured to engage the external threads of the inner shaft thread portion 154 such that rotation of the steering knob 110 causes corresponding axial movement of the grasping element 190 toward the first state or the second state depending on the direction of rotation of the steering knob 110.

[0178] Figure 1C An enlarged perspective view of the distal region of the non-penetrating tissue separator 100 in the first state is shown, wherein the grasping element 190 is positioned proximal to the distal vertebral lip 174. Figure 1D An enlarged view of the Figure 1C transition state between the first state and the second state is shown. Figure 1E An enlarged view of the Figure 1C in the second state is shown, wherein the grasping element 190 is distally spaced from the distal vertebral lip 174. Figure 1F An enlarged cross-sectional side view of the distal portion of the non-penetrating tissue separator 100 is shown, the non-penetrating tissue separator 100 being in a state Figure 1E before or after such that the grasping element 190 is positioned distal to the distal vertebral lip 174, but its proximal surface 194 is not distally spaced from the distal vertebral lip 174.

[0179] According to some embodiments, the vertebral head 160 is connected to the outer shaft 120 via an intermediate connector 162 (see Figure 1F ), wherein the intermediate connector 162 is fixedly attached to the distal portion 124 of the outer shaft, and the proximal vertebral portion 164 is attached to the intermediate connector 162.

[0180] According to some embodiments, such as Figures 1A to 1FIn the illustrated embodiment, the vertebral head 160 includes a plurality of wings 170 oriented in the distal axial direction, such as wings 170a, 170b, 170c, and the plurality of wings 170 are separated by notches between the plurality of wings 170. Each wing 170 includes a wing distal lip 172, and the plurality of wing distal lips 172, such as wing distal lips 172a, 172b, 172c, together form a vertebral distal lip 174. The vertebral head 160 and the wings 170 are configured to switch between a non-expanded state (see Figure 1C ) and an expanded state (see Figures 1D to 1E ).

[0181] According to some embodiments, the wings 170 have internal flexibility such that the wings 170 are spring-biased radially inwardly (see Figure 1C ), and can be pushed radially outwardly by a force applied to the wings 170 (see Figure 1D ), such that the wing distal lips 172 expand radially away from each other to form a vertebral opening 168 that is wider than the non-expanded posture with respect to Figure 1C .

[0182] According to some embodiments, the vertebral body 160 further includes a wing bending point 176 located between the proximal portion 164 of the vertebral body and the distal portion 166 of the vertebral body at the proximal end of the notch between the wings. The wing bending point 176 can be formed as a notched groove having a diameter slightly larger than the width of the notch, and is configured to provide additional flexibility for the wings.

[0183] According to some embodiments, each wing 170 further includes a wing proximal straight surface 180 extending distally from the region of the bending point 176 (see Figure 1F ), a first wing inclined portion 182 extending distally from the wing proximal straight surface 180 and radially inwardly inclined, a wing inner shoulder 184 extending distally from the first wing inclined portion 182, and a second wing inclined portion 186 extending distally from the wing inner shoulder 184 and radially outwardly inclined, which terminates at the wing distal lip 172. The wing proximal straight surface 180, the first wing inclined portion 182, the wing inner shoulder 184, and the second wing inclined portion 186 together form the inner vertebral surface 178.

[0184] Figure 1C A grasping element 190 is shown in a first state, and the grasping element 190 is positioned proximal to the wing distal lip 172, and more specifically, adjacent to or in contact with the outer shaft distal lip 126. The vertebral head 160 and the wings 170 are shown in Figure 1C in a non-expanded state, in which the wings 170 are biased radially inwardly towards each other such that the diameter of the vertebral opening 168 is smaller than the diameter of the grasping element 190.

[0185] The vertebral head 160 and the wings 170 are inFigure 1D is shown in an expanded state, in which the wings 170 are bent radially outward. According to some embodiments, the non-penetrating tissue separator 100 includes a mechanism configured to radially expand the wings 170 outwardly, such as a cable or thread attached to the outer surface of the wings 170 or the wing lip 172, and the mechanism can be pulled in the proximal direction, for example, by pulling the proximal end of the cable or thread at the handle 102, to expand the wings 170 (not shown in the embodiments).

[0186] According to some embodiments, the wings 170 are configured to radially expand outwardly due to an internal thrust applied to the inner surface 178 of the vertebral body during axial movement of the grasping element 190 along the inner surface 178 of the vertebral body, such as moving towards the second state.

[0187] The wing proximal straight surface 180 is configured to enable the grasping element 190 to translate axially along the wing proximal straight surface 180 without expanding the wings 170. The axial length of the wing proximal straight surface 180 defines a path extending from the distal portion 126 of the outer shaft, and the axial movement of the grasping element 190 along this path does not apply any force to the wings 170.

[0188] When the grasping element 190 is further pushed distally along the first wing inclined portion 182, the wings slide on the circumferential surface 198 of the grasping element 190 and radially expand outwardly. As the grasping element 190 continues to advance in the distal direction 92, the grasping element 190 further slides past the inner wing shoulder 184 and the second wing inclined portion 186 until the grasping element 190 exits the cone head 160 through the cone opening 168. Figure 1E The grasping element 190 is shown positioned distally spaced from the wing distal lip 172 in the second state. The grasping element 190 can also be pulled back in the proximal direction 94.

[0189] According to some embodiments, the inner wing shoulder 184 is configured to abut or press against the outer surface 148 of the inner shaft when the grasping element 190 exits the cone head 160 through the cone opening 168, and the second wing inclined portion 186 is inclined at an angle defining the outer diameter of the vertebral opening 168, and the outer diameter of the vertebral opening 168 is smaller than the outer diameter of the grasping element 190. In this way, when the grasping element 190 retracts in the proximal direction 94 from the second state, the proximal surface 194 of the grasping element 190 is prevented from re-entering the cone head 160 (see Figure 1F ).

[0190] According to some embodiments, the second wing ramp 186 is angled to define an outer diameter of the vertebral body opening 168 that is greater than the outer diameter of the grasping element 190 when the medial wing shoulder 184 abuts the outer surface 148 of the inner shaft, to allow the grasping element 190 to potentially retract proximally back into the vertebral head 160 toward the first posture.

[0191] According to some embodiments, the wings 170 are plastically deformable such that when the wings 170 are bent radially outward, the wings 170 remain in that position and do not attempt to bend back toward each other.

[0192] According to some embodiments, the vertebral head 160 provides an atraumatic interface configured to avoid tissue damage. According to some embodiments, the distal vertebral lip 174 is blunt rather than sharp, for example, rounded.

[0193] According to some embodiments, the non-penetrating tissue dissector 100 further includes an atraumatic end cap (not shown) configured to cover the distal end of the device 100 to provide an atraumatic distal interface that reduces tissue damage during advancement of the device 100 toward the patient's heart. According to some embodiments, the atraumatic end cap is attached to or covers the distal outer edge.

[0194] According to some embodiments, the atraumatic end cap includes a flap that allows the grasping element 190 or other instrument to be pushed distally and passed through.

[0195] According to some embodiments, the grasping element 190 is transitioned between the first state and the second state by retracting the outer shaft 120 along with the vertebral head 160 in the proximal direction rather than advancing the inner shaft 140 in the distal direction. In such an embodiment, the relative interaction between the grasping element 190 and the vertebral head 160 is the same as the relative interaction between the elements described above, which includes an optional radial displacement of the wings 170 that slide over the grasping element 190.

[0196] Now referring to Figures 2A to 2F , which shows different embodiments of the grasping element 190. The grasping element 190 includes a grasping element inner opening 192, a grasping element proximal surface 194, a grasping element distal surface 196, and a grasping element circumferential surface 198.

[0197] According to some embodiments, the grasping element inner opening 192 is substantially equal to the diameter of the inner shaft lumen 152. According to some embodiments, the grasping element inner opening 192 and the inner shaft lumen 152 are coaxial.

[0198] As used herein, the term "substantially" means a maximum optional deviation of 10% from the reference value.

[0199] According to some embodiments, the grasping element 190 further includes surface features 188 disposed along at least one surface of the grasping element 190. According to some embodiments, the surface features 188 are disposed along at least one of the distal surface 196 of the grasping element and the circumferential surface 198 of the grasping element. According to some embodiments, the surface features 188 are disposed along the proximal surface of the grasping element.

[0200] According to some embodiments, the grasping element 190 is disc-shaped.

[0201] Figure 2A An embodiment of the grasping element 190 provided with surface features 188 in the form of radial ridges is illustrated a is shown: The radial ridges extend along the distal surface 196 of the grasping element a a extends. Figure 2B An embodiment of the grasping element 190 provided with surface features 188 in the form of dimples is illustrated b is shown: The dimples project from the distal surface 196 of the grasping element b b protrude.

[0202] Figure 2C An embodiment of the grasping element 190 provided with surface features 188 in the form of radial extensions is illustrated c is shown: The radial extensions are disposed along the distal surface 196 of the grasping element c and project distally from the distal surface 196 of the grasping element, and are disposed along the circumferential surface 198 of the grasping element c c and project distally from the circumferential surface 198 of the grasping element c c protrude distally. Figure 2D An embodiment of the grasping element 190 having surface features 188 in the form of radial extensions is shown d is shown: The radial extensions are spaced farther apart from each other than the surface features 188 d c and project farther distally from the distal surface 196 of the grasping element and farther radially from the circumferential surface 198 of the grasping element d d respectively.

[0203] Figure 2E An embodiment of the grasping element 190 provided with surface features 188 in the form of radial extensions is illustrated e is shown: The radial extensions are disposed along the distal surface 196 of the grasping element e e and project distally from the distal surface 196 of the grasping element e ​​​​​​​projects distally and is disposed circumferentially along the grasping element surface 198 e is disposed from the circumferential surface 198 of the grasping element e projects distally and is chamfered along the transition corner between the axial projection and the radial projection.

[0204] Figure 2F illustrates an embodiment of a grasping element 190 having surface features 188 in the form of circumferentially curved atraumatic serrations f ; the atraumatic serrations are disposed along the distal surface 196 of the grasping element f projects distally from the distal surface 196 of the grasping element f and is disposed circumferentially along the circumferential surface 198 of the grasping element f projects distally from the circumferential surface 198 of the grasping element f is disposed and projects distally. f

[0205] Figures 2A to 2F The illustrated embodiment shows an exemplary configuration. Alternative configurations will be apparent to those skilled in the art.

[0206] The surface feature 188 is an atraumatic surface feature configured to engage tissue in a releasable manner without cutting, slicing, or penetrating the tissue. To this end, the surface feature 188 is formed as a blunt rather than a sharp feature. According to some embodiments, the grasping element 190 is shaped as an atraumatic element configured to engage tissue without cutting, slicing, or penetrating the tissue. According to some embodiments, all edges of the grasping element 190 (including all edges of the surface feature 188) are blunt rather than sharp, e.g., rounded.

[0207] Regarding the engagement between the atraumatic surface feature 188 and the tissue with which it contacts, the term "engage in a releasable manner" means that the shape of the atraumatic surface feature is such that tissue can be grasped and wound when the grasping element 190 is rotated about the central axis of the grasping element 190 in one direction, whereas when the grasping element 190 is rotated in the opposite direction, the tissue can be released (i.e., disengaged or unwound) from the grasping element 190 such that the tissue remains uninjured by the atraumatic surface feature when released from the engagement with the atraumatic surface feature. The term "uninjured" means that the tissue is not cut, sliced, or penetrated by the grasping element 190.

[0208] The grasping element 190 is configured to engage and grasp tissue through the surface features 188 during rotation of the grasping element 190 without cutting or penetrating the tissue. The surface features 188 are also configured to: hold the tissue engaged with the grasping element 190 once its rotational movement stops, that is to say, prevent the tissue from sliding around the grasping element 190 and prevent the tissue from disengaging from the grasping element after the rotation of the grasping element 190 stops, unless the grasping element rotates in the opposite direction.

[0209] According to some embodiments, the surface features 188 include a rough surface that is configured to engage and grasp tissue by applying frictional force during the rotational movement of the grasping element 190.

[0210] Advantageously, since the surface features 188 do not penetrate the tissue, rotation of the grasping element 190 in a direction opposite to the tissue engagement direction can easily, quickly, conveniently, and safely achieve disengagement of the tissue from the grasping element.

[0211] According to some embodiments, the inner opening 192 of the grasping element does not have the surface features 188, that is to say, the inner opening 192 of the grasping element includes a relatively smooth surface without extensions such as tabs, recesses, teeth, etc., because the inner opening 192 of the grasping element is not configured to grasp tissue, but provides a passage for other devices that can pass through the passage and enter the tissue towards the tissue, and the tissue is grasped by the surface features 188 along at least one of the distal surface 196 of the grasping element or the circumferential surface 198 of the grasping element.

[0212] According to some embodiments, the surface features 188 are oriented in the axial direction or radially outward, but not radially inward. That is to say, none of the surface features 188 are oriented towards each other.

[0213] According to some embodiments, at least one of the distal surface 196 of the grasping element or the proximal surface 194 of the grasping element is formed as a curved surface (not shown in the embodiment).

[0214] According to some embodiments, the distal surface 196 of the grasping element is concave. According to some embodiments, both the distal surface 196 of the grasping element and the proximal surface 194 of the grasping element are concave. This configuration advantageously forms a non-damaging shape of the grasping element 190.

[0215] According to some embodiments, both the distal surface 196 of the grasping element and the proximal surface 194 of the grasping element are convex.

[0216] Advantageously, a curved surface, such as a convex or concave distal surface 196 of the grasping element, provides a larger tissue grasping area.

[0217] Now refer to Figures 3A to 3E , which illustrates different steps of a method of using a non-penetrating tissue separator 100 according to some embodiments. Figure 3A Illustrates the first step of the method, in which a distal region of the non-penetrating tissue separator 100, including at least a portion of the outer shaft 120 and the inner shaft 140, the grasping element 190, and the vertebral head 160, is inserted into the patient's body and advanced distally towards the patient's heart 10 when the non-penetrating tissue separator 100 is in a first state - in other words, when the grasping element 190 is positioned proximal to the distal outer edge of the non-penetrating tissue separator 100.

[0218] When the distal outer edge approaches the heart 10 such that the distal outer edge is at or near the pericardium 14, the operator maneuvers the non-penetrating tissue separator 100 to move the grasping element 190 from the first state to the second state. If the vertebral head 160 includes a plurality of wings 170, the plurality of wings 170 radially expand during the displacement of the grasping element 190 from the first state to the second state (see Figure 3B ). According to some embodiments, the grasping element 190 is positioned in the second state such that the grasping element 190 is distally spaced from the vertebral distal lip 174 (see Figure 3B ).

[0219] According to some embodiments, the grasping element 190 is moved from the first state to the second state by advancing the inner shaft 140 distally relative to the outer shaft 120, for example by rotating the steering knob 110. According to some embodiments, the grasping element 190 is moved from the first state to the second state by retracting the outer shaft 120 proximally relative to the inner shaft 140. According to some embodiments, the grasping element 190 is moved from the first state to the second state by pushing the inner shaft 140 in the distal direction relative to the outer shaft 120.

[0220] If the grasping element 190 has not contacted the pericardium 14 after transitioning to the second state, the grasping element 190 is further advanced distally to contact or bear against the pericardium 14. When the grasping element 190 contacts the pericardium 14, the operator maneuvers the non-penetrating tissue separator 100 to rotate the grasping element 190 about the central axis of the grasping element 190. According to some embodiments, the rotation of the grasping element 190 is achieved by rotating the inner shaft 140.

[0221] According to some embodiments, the handle 102 further includes a knob (not shown), which is disposed, for example, within the first handle recess 108 or near the proximal portion 106 of the handle and is fixedly attached to the outer surface 148 of the inner shaft such that rotation of the knob facilitates rotation of the inner shaft 140 and the grasping element 190.

[0222] The tension applied to the pericardium 14 via the surface feature 188 during the rotational movement of the grasping element 190 causes tissue to wrap around the grasping element 190 as Figure 3B shown, without being cut or punctured by the grasping element. The grasping element 190 is rotated at least until the pericardium 14 wraps around at least a portion of the circumferential surface 198 of the grasping element. According to some embodiments, the grasping element 190 is further rotated such that the pericardium 14 wraps around the circumferential surface 198 and the proximal surface 194 of the grasping element.

[0223] Once the tissue of the pericardium 14 is wrapped around the grasping element 190, the operator manipulates the non-penetrating tissue separator 100 to pull the grasping element 190 in the proximal direction 94, thereby creating a passage space or working space 16 formed between the proximally wrapped portion of the pericardial wall layer 14 and the epicardial surface 12.

[0224] As used herein, the terms "pericardium" and "pericardial wall layer" are interchangeable.

[0225] According to some embodiments, the entire non-penetrating tissue separator 100 is pulled in the proximal direction 94 to form the pericardial space 16, with no relative movement between the inner shaft 140 and the outer shaft 120.

[0226] According to some embodiments, the pericardial space 16 is formed by pulling the inner shaft 140 relative to the outer shaft 120 in the proximal direction 94. According to some embodiments, the grasping element 190 is pulled in the proximal direction 94 until the pericardium 14 wrapped around the grasping element 190 is squeezed between the grasping element 190 and at least a portion of the vertebral head 160, thereby locking the wrapped pericardial tissue 14 between the grasping element 190 and the said at least a portion of the vertebral head 160.

[0227] According to some embodiments, as Figure 3C shown, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal lip 174 of the vertebra. According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element and the inner surface 178 of the vertebra.

[0228] According to some embodiments, the grasping element 190 is pulled in the proximal direction 94 until the pericardium 14 wrapped around the grasping element 190 is squeezed between the grasping element 190 and at least a portion of the outer shaft 120, thereby locking the wrapped pericardial tissue 14 between the grasping element 190 and the said at least a portion of the outer shaft 120.

[0229] According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal lip 126 of the outer shaft. According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element and a portion of the inner surface 130 of the outer shaft.

[0230] According to some embodiments, a kit is provided that includes a non-penetrating tissue separator 100 and an access device configured to pierce, cut, or penetrate the pericardium 14 to provide access to the working space 16. According to some embodiments, the access device is sized and shaped to pass through the inner shaft lumen 152 and exit the inner opening 192 of the grasping element.

[0231] According to some embodiments, the access device includes a needle 20 that includes a needle shaft having a proximal needle portion 22 and a sharp distal needle portion 24. Figure 3D The following steps are shown: advancing the distal needle portion 24 in the direction 92 to pierce that portion of the pericardium 14 that extends along the inner opening 192 of the grasping element, thereby providing access to the working space 16.

[0232] According to some embodiments, the pericardium 14 is wrapped around the grasping element 190 such that the pericardium 14 extends against the inner opening 192 of the grasping element, thereby enabling the pericardium 14 to be more easily pierced.

[0233] According to some embodiments, the proximal needle portion 22 includes a needle limiting element 26 that is configured to abut against a portion of the proximal part of the handle 104, such as the handle inlet 107. According to some embodiments, the outer diameter of the needle limiting element 26 is greater than the inner diameter of the handle inlet 107, thereby preventing the needle 20 from advancing further distally to limit the penetration depth of the needle 20 and avoid piercing the epicardial surface.

[0234] Although Figure 3D the needle 20 in Figure 27D is shown as penetrating the pericardial space 16 such that the distal tip of the needle 20 extends distally beyond the grasping element 190, according to some embodiments, the needle is prevented from moving distally beyond the distal lip 174 of the vertebral body (see

[0235] According to some embodiments, the distal needle portion 24 is bent or curved to an extent such that the direction of the sharp tip of the distal needle portion 24 is offset from the longitudinal axis or centerline of the needle shaft (see Figure 3D ). Such an embodiment can advantageously provide a perpendicular access of the distal needle portion 24 to the pericardium 14 or other tissue of interest whenever the distal portion of the non-penetrating tissue separator 100 is angled relative to the pericardium 14 or other tissue of interest. Advantageously, the bent / curved distal needle portion 24 further supports its anterior or posterior approach.

[0236] Other types of access devices may be provided in the kit. The inventors' international application publication WO 2018 / 235072 discloses an access device that includes a thread having a circumferentially oriented sharp end, the thread being configured to pierce or penetrate the pericardium from a lateral direction during its rotation. Such an access device can be used instead of a needle. According to some embodiments, the access device provided in the kit together with the non-penetrating tissue separator 100 is in the form of the access device disclosed in WO 2018 / 235072.

[0237] According to some embodiments, an access device having a distal piercing element, such as a distally oriented sharp tip formed at the distal end of an axial thread, may be provided in the kit. Such an access device can be delivered through the inner shaft lumen 152 to the pericardium 14, which is used to pierce the pericardium 14 held by the non-penetrating tissue separator 100, for example, by rotating the access device to facilitate piercing of the pericardium 14 by the distally oriented sharp tip and piercing the pericardium 14 held by the non-penetrating tissue separator 100.

[0238] According to some embodiments, a kit is provided that includes a non-penetrating tissue separator 100, an access device, and a guide wire. Figure 3E A further step of introducing the guide wire 30 into the working space 16 through an incision or puncture hole formed in the pericardium by the access device is shown. According to some embodiments, the guide wire 30 is advanced through the lumen of the access device, such as the lumen of the needle 20.

[0239] According to some embodiments, once an incision or puncture hole is formed in the pericardium, the access device, such as the needle 20, is retracted and removed from the non-penetrating tissue separator 100. According to some embodiments, the guide wire 30 is advanced through the inner shaft lumen 152 and the inner opening 192 of the grasping element.

[0240] According to some embodiments, the non-penetrating tissue separator 100 further includes a coupling, such as a Luer lock, that is near the proximal portion 104 of the handle and is used to provide access to an external device, such as the guide wire 30. According to some embodiments, the Luer lock is attached to the handle inlet 107 (not shown in the embodiment).

[0241] As used herein, the terms "centerline," "central axis," or "longitudinal axis" of an element are interchangeable and refer to the set of centroids of all cross-sections of the element. The centerline may be curved such that the orientation of the centerline changes along the length of the centerline. A "local" centerline refers to the tangent to the centerline at or approximately near the point of interest.

[0242] According to some embodiments, any one of the outer shaft 120, the inner shaft 140, or the vertebral head 160 may be made of a lubricated or low-friction material, or may have an outer layer (along the respective outer surface) made of a lubricated or low-friction material such as PTFE.

[0243] According to some embodiments, a non-penetrating tissue separator 100 is provided, the non-penetrating tissue separator 100 including a vertebral head 160 n threadedly engaged with a threaded grasping element 190 n (not shown in the embodiment). The vertebral head 160 n includes a plurality of wings 170 n , the wings 170 n oriented in the distal axial direction and separated by notches between the wings 170 n . Each wing 170 n includes a wing distal lip 172 n , wherein the plurality of wing distal lips 172 n together form a vertebral distal lip 174 n . At least a portion of the inner vertebral surface 178 n (e.g., at least a portion formed by at least a portion of the inner surface of the wings 170 n ) includes internal threads.

[0244] The grasping element circumferential surface 198 n includes external threads that match the internal threads of the vertebral head 160 n . The external threads of the grasping element 190 n engage with the internal threads of the vertebral head 160 n . According to some embodiments, when the grasping element 190 n is in a first state, the vertebral head 160 n is arranged such that the wings 170 n of the vertebral head 160 n are in an unexpanded state (similar to the state of the wings 170 in Figure 1C ) and are configured to expand when the grasping element 190 n is threadedly conveyed distally to a second state.

[0245] In use, when the grasping element 190 n is rotated in one direction during its distal conveyance, the rotational threaded engagement promotes the radial expansion of the wings 170 n . According to some embodiments, the wings 170 n are provided with inclined or skewed inner surfaces that are configured to, when the grasping element 190 nPromote its desired radial expansion during the threading movement along the inner surface. According to some embodiments, the wing 170 n is also configured to radially contract inwardly when the grasping element 190 n retracts proximally towards the first state.

[0246] According to some embodiments, at least some and possibly all of the steps of advancing and operating the non-penetrating tissue separator 100 are facilitated by at least one imaging or sensing device. According to some embodiments, the non-penetrating tissue separator 100 includes at least one sensor (not shown in the embodiments) that facilitates at least one of its functions.

[0247] According to some embodiments, the non-penetrating tissue separator 100 includes at least one optical sensor. According to some embodiments, the non-penetrating tissue separator 100 includes at least one impedance sensor. According to some embodiments, the non-penetrating tissue separator 100 includes at least one ultrasonic sensor. According to some embodiments, the non-penetrating tissue separator 100 includes at least one mechanical sensor, such as a spring-based sensor.

[0248] According to some embodiments, the non-penetrating tissue separator 100 includes at least one electrical sensor, such as an ECG electrode, configured to be in electrical communication with an ECG monitor. The sensor can be used as an electrode to sense and record electrical signals in cardiac tissue. In such an embodiment, the ECG monitor can provide feedback to the operator of the non-penetrating tissue separator 100 to facilitate its operation. According to some embodiments, the ECG monitor can provide feedback regarding the current posture of a particular part or element of the non-penetrating tissue separator 100.

[0249] Now refer to Figures 4A to 4B . Figure 4A and Figure 4B respectively constitute a perspective view and a cross-sectional side view of the non-penetrating tissue separator 100 according to some embodiments. The non-penetrating tissue separator 100 a is similar to the non-penetrating tissue separator 100 described above, except that the vertebral head 160 a does not have expandable wings. a Specifically, the vertebral head 160

[0250] is formed as a rigid and non-deformable structure that includes a proximal vertebral portion 164 attached to the distal portion 124 of the outer shaft a and a distal vertebral portion 166 extending distally from the proximal vertebral portion 164 a and the distal vertebral portion 166 a extends distally from the proximal vertebral portion 164 a , and the distal vertebral portion 166 aIncreases radially outwardly such that the diameter of its vertebral body opening 168a is greater than the diameter of the outer shaft 120. The vertebral head 160 a Operates and includes all embodiments described above for the vertebral head 160 that do not involve relative movement or operation of the wings 170.

[0251] Now refer to Figures 5A to 5D , which depicts different steps of a method of using a non-penetrating tissue separator 100 according to some embodiments a . Figure 5A Illustrates the first step of the method, in which a distal portion of the non-penetrating tissue separator 100 including at least a portion of the outer shaft 120 and the inner shaft 140, the grasping element 190, and the vertebral head 160 a Is inserted into the patient and advanced distally towards the patient's heart 10 when the non-penetrating tissue separator 100 a Is in a first state - in other words, when the grasping element 190 is positioned proximal to the distal vertebral lip 174 a .

[0252] When the distal outer edge approaches the heart 10 such that the distal outer edge is at or near the pericardium 14, the operator manipulates the non-penetrating tissue separator 100 a To move the grasping element 190 from the first state to the second state. According to some embodiments, the grasping element 190 is positioned in the second state such that the grasping element 190 is spaced distally from the distal vertebral lip 174 a (see Figure 5B ).

[0253] The grasping element 190 is advanced distally in the second state to contact the pericardium 14. When the grasping element 190 is at the pericardium 14, the operator manipulates the non-penetrating tissue separator 100 a To cause the grasping element 190 to rotate about the central axis of the grasping element 190.

[0254] During the rotational movement of the grasping element 190, the surface features 188 cause tissue such as Figure 5B To wrap around the grasping element 190 as shown without being cut or pierced by the grasping element. Once the tissue of the pericardium 14 is wrapped around the grasping element 190, the operator manipulates the non-penetrating tissue separator 100 a To pull the grasping element 190 in the proximal direction to create a working pericardial space 16 (see Figure 5C ).

[0255] According to some embodiments, the grasping element 190 is pulled in the proximal direction 94 until the pericardium 14 wrapped around the grasping element 190 is squeezed between the grasping element 190 and the vertebral head 160a until at least a portion thereof, thereby locking the wrapped pericardial tissue 14 between the grasping element 190 and the vertebral head 160 a between at least a portion of said.

[0256] According to some embodiments, as Figure 5C shown, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal lip 174 of the vertebral body a therebetween. According to some embodiments, as Figure 5C and Figure 5D both shown, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element and the inner surface 178 of the vertebral body a therebetween.

[0257] According to some embodiments, the grasping element 190 is pulled in the proximal direction 94 until the pericardium 14 wrapped around the grasping element 190 is squeezed between the grasping element 190 and at least a portion of the outer shaft 120, thereby locking the wrapped pericardial tissue 14 between the grasping element 190 and at least a portion of the outer shaft 120.

[0258] According to some embodiments, as Figure 5D shown, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal lip 126 of the outer shaft.

[0259] According to some embodiments, a method of using the non-penetrating tissue separator 100 is provided, wherein the operator manipulates the non-penetrating tissue separator 100 to move the grasping element 190 from a first state to a second state before inserting the non-penetrating tissue separator 100 into the patient. The distal portion of the non-penetrating tissue separator 100 including at least a portion of the outer shaft 120 and the inner shaft 140, the vertebral head 160 a and the grasping element 190 is then inserted into the patient and advanced distally toward the patient's heart 10. The remaining steps are similar to those described above for Figures 5B to 5D as described.

[0260] Now refer to Figures 6A to 6B . Figure 6A and Figure 6BAn enlarged cross-sectional view of the distal region of the non-penetrating tissue separator 100 and the corresponding anatomical heart tissue in two successive steps of creating the pericardial space 16. The ventricle 11 is surrounded by several layers of tissue. The pericardial space 16 is formed by further separating the pre-existing narrow chamber between the heart wall and the pericardium 14 using the non-penetrating tissue separator 100. The heart wall covering the ventricle 11 includes several tissue layers: the endocardium 13, the myocardium 15, and the epicardium 12. The pericardium 14 itself also consists of fibrous pericardial tissue 14a covering the pericardial wall layer 14b.

[0261] Typically, the pericardium 14 and the heart wall are in close contact, separated only by a thin layer of pericardial fluid. When the grasping element 190 is advanced to contact the pericardium 14 and then rotated about the centerline of the grasping element 190, the pericardium 14, including both the fibrous layer 14a and the wall layer 14b, is wound around the grasping element 190. In Figure 6A the exemplary embodiment shown, the pericardium 14 is wound around the grasping element 190 such that the pericardium 14 engages the distal surface 196 of the grasping element, the circumferential surface 198 of the grasping element, and the proximal surface 194 of the grasping element. In other embodiments, the grasping element 190 can be rotated such that the pericardium 14 engages and is wound around only one or some of the surfaces of the grasping element 190 - such as the distal surface 196 of the grasping element and the circumferential surface 198 of the grasping element.

[0262] The separation between the layers is achieved by pulling the grasping element 190 in the proximal direction 94, thereby spacing the pericardium 14 distally away from the heart wall, and specifically spacing the pericardial wall layer 14b away from the epicardial surface 12 to create an enlarged pericardial space 16 between the pericardial wall layer 14b and the epicardial surface 12. According to some embodiments, the grasping element 190 is pulled until the grasping element 190 can no longer move in the proximal direction 94 under the action of a conventional pulling force applied to the grasping element 190 - such as a manual pulling force applied by the operator of the non-penetrating tissue separator 100.

[0263] In Figure 6B the exemplary embodiment shown, the grasping element 190 is retracted until the pericardium 14 is squeezed between the circumferential surface 198 of the grasping element and the inner surface 178 of the vertebral body a therebetween.

[0264] In other embodiments, the grasping element 190 is pulled until the pericardium 14 is squeezed between at least one or some of the surfaces of the grasping element 190 and at least one or some of the distal lip 174 of the vertebral body, the inner surface 178 of the vertebral body, the distal lip 126 of the outer shaft, and the inner surface 130 of the outer shaft.

[0265] Advantageously, the procedure of grasping the pericardium 14 and pulling the pericardium 14 in the proximal direction 94 to create an enlarged pericardial space 16 is performed without cutting or perforating any tissue in any tissue including the pericardium 14 or the heart wall - such as the epicardium 12, the myocardium 15, and the endocardium 13.

[0266] It will be appreciated that although other figures of the present specification - such as Figures 3B to 3E , Figures 10A to 10C , Figures 19A to 19C , Figures 21A to 21C , Figures 27A to 27D , Figures 29A to 29B and Figures 33A to 33B - may illustrate the pericardial space 16 formed between the pericardium 14 and the epicardial surface 12 for simplicity, the pericardium 14 represents both the fibrous layer 14a and the parietal layer 14b as shown in Figures 6A to 6B , and the epicardial surface 12 represents the layer covering the remaining layers of the heart wall - including the endocardium 13 and the myocardium 15 as shown in Figures 6A to 6B .

[0267] According to some embodiments, the non-penetrating tissue separator 100 does not necessarily have to include the vertebral head 160. Now referring to Figures 7A to 10C , which illustrates an embodiment of the non-penetrating tissue separator 100 without the vertebral head 160.

[0268] Figure 7A Is a perspective view of the non-penetrating tissue separator 100 according to some embodiments. Figure 7B And Figure 7C Respectively constitute Figure 7A The non-penetrating tissue separator 100 is respectively in a cross-sectional side view in the first state and the second state. Except for the absence of the vertebral head 160, the non-penetrating tissue separator 100 includes all other components that are structurally and functionally similar to the non-penetrating tissue separators disclosed throughout the present specification.

[0269] According to some embodiments, the outer diameter of the grasping element 190 is smaller than the diameter of the outer shaft lumen 132, such that the grasping element 190 can be inserted into the outer shaft lumen 132. In such an embodiment, the outer shaft distal lip 126 serves as the distal outer edge. Figure 7B Illustrates the grasping element 190 positioned in the first state such that the distal surface 196 of the grasping element 190 is close to or flush with the outer shaft distal lip 126.

[0270] According to some embodiments, the non-penetrating tissue separator 100 further includes an inner shaft retraction limiting mechanism configured to limit the maximum retraction of the grasping element 190 in the proximal direction up to a specific position, for example, to limit the movement of the grasping element 190 so that the grasping element 190 does not advance too far proximally into the outer shaft lumen 132 (not shown in the embodiment). This can be beneficial to ensure that the grasping element 190 is flush with or only spaced apart by a relatively short desired distance from the outer shaft distal lip 126 in the first posture.

[0271] As an example, an exemplary inner shaft retraction limiting mechanism may include an outer protrusion extending radially outward from the outer surface 148 of the inner shaft, which is positioned distally of a corresponding inner protrusion extending radially inward from the inner surface 130 of the outer shaft and is configured to engage with the corresponding inner protrusion, thereby preventing further proximal movement of the inner shaft 140 relative to the outer shaft 120, or preventing further distal movement of the outer shaft 120 relative to the inner shaft 140 (not shown in the exemplary embodiment).

[0272] Figure 7C The grasping element 190 is illustrated in a second state, in which the proximal surface 194 of the grasping element 190 is spaced distally from the outer shaft distal lip 126. According to some embodiments, Figure 7C the second state shown in is achieved by pushing the inner shaft 140 together with the grasping element 190 relative to the outer shaft 120 in the distal direction 92. According to some embodiments, Figure 7C the second state shown in is achieved by pulling the outer shaft 120 relative to the grasping element 190 in the proximal direction 94.

[0273] According to some embodiments, such as Figures 7A to 7C the embodiment shown in, the outer shaft lumen 132 has a uniform diameter along the length of the outer shaft 120 or at least along the length of the outer shaft distal portion 124. According to some embodiments, the outer shaft 120 further includes an outer shaft distal tapered portion 136.

[0274] Figure 8A and Figure 8B constitute cross-sectional side views of the non-penetrating tissue separator 100 equipped with the outer shaft 120 a in the first state and the second state, respectively. The outer shaft 120 a is similar to Figures 7B to 7C the outer shaft 100 shown in, except that the outer shaft lumen 132 of the outer shaft 120 a also includes an outer shaft distal tapered portion 136 a which extends from the outer shaft distal lip 126 a a ​Tapers radially inwardly towards the proximal until a boundary from which the remainder of the outer shaft lumen 132 a may be provided with a uniform diameter that is greater than the outer diameter of the inner shaft 140.

[0275] According to some embodiments, the outer diameter of the grasping element 190 is less than the diameter of the distal end of the distal tapered portion 136 of the outer shaft a such that the grasping element 190 can be inserted into the distal portion of the distal tapered portion 136 of the outer shaft a of the outer shaft. Figure 8A Illustrates the grasping element 190 positioned in a first state such that the distal surface 196 of the grasping element 190 is adjacent to or a flush with the distal lip 126 of the outer shaft a of the outer shaft.

[0276] According to some embodiments, the distal tapered portion 136 of the outer shaft a serves as an inner shaft retraction limiting mechanism such that at least the proximal portion of the distal tapered portion 136 of the outer shaft a has a tapered diameter that is less than the outer diameter of the grasping element 190. Thus, the distal tapered portion 136 of the outer shaft a is configured to receive the grasping element 190 within the distal tapered portion 136 of the outer shaft a in a first position while preventing further proximal retraction of the grasping element 190 when the grasping element 190 engages the inner surface of the distal tapered portion 136 of the outer shaft a of the outer shaft.

[0277] Figure 8B Illustrates the grasping element 190 positioned in a second state in which the proximal surface 194 of the grasping element 190 is distally spaced from the distal lip 126 of the outer shaft a of the outer shaft. According to some embodiments, Figure 8B the second state shown is achieved by pushing the inner shaft 140 together with the grasping element 190 relative to the outer shaft 120 a in the distal direction 92. According to some embodiments, Figure 8B the second state shown in is achieved by pulling the outer shaft 120 a relative to the grasping element 190 in the proximal direction 94.

[0278] Figure 9A Comprises a perspective view of a non-penetrating tissue separator 100 equipped with an outer shaft 120 b according to some embodiments. Figure 9B and Figure 9C Comprises Figure 9A cross-sectional side views of the non-penetrating tissue separator 100 in the first and second states respectively. The outer shaft 120 bSimilar to Figures 7B to 7C the outer shaft 100 shown, except that the outer shaft 120 b has an outer shaft lumen 132 b and further includes an outer shaft distal slot 135 that extends between the outer shaft distal lip 126 b and the outer shaft distal slot shoulder 137 b . The outer shaft distal slot 135 b has a uniform outer diameter that is larger than the outer diameter of the remainder of the outer shaft lumen 132 b that extends proximally from the outer shaft distal slot shoulder 137 b . b

[0279] Figure 9B Illustrated is the grasping element 190 positioned in a first state such that the distal surface 196 of the grasping element 190 is adjacent to or flush with the outer shaft distal lip 126 b . The outer diameter of the grasping element 190 is less than the inner diameter of the outer shaft distal slot 135 b and greater than the inner diameter of the remainder of the outer shaft lumen 132 b . b

[0280] According to some embodiments, the axial length of the outer shaft distal slot 135 b defined between the outer shaft distal lip 126 b and the outer shaft distal slot shoulder 137 b is equal to or greater than the axial length of the grasping element 190 defined between the distal surface 196 and the proximal surface 194 of the grasping element, and this axial length is configured to accommodate the grasping element 190 therein in the first state.

[0281] According to some embodiments, the outer shaft distal slot shoulder 137 b serves as an inner shaft retraction limiting mechanism such that when the proximal surface 194 of the grasping element abuts or engages the outer shaft distal slot shoulder 137 b , further proximal retraction of the grasping element 190 is prevented.

[0282] Figure 9C Illustrated is the grasping element 190 positioned in a second state, wherein the proximal surface 194 of the grasping element 190 is distally spaced from the outer shaft distal lip 126 b . According to some embodiments, Figure 9C the second state shown in is achieved by pushing the inner shaft 140 together with the grasping element 190 relative to the outer shaft 120 b in the distal direction 92. According to some embodiments, Figure 9C ​​The second state shown in FIG. is achieved by pulling the outer shaft 120 in the proximal direction 94 relative to the grasping element 190 b as follows.

[0283] Now referring to Figures 10A to 10C , which depicts various steps of a method of using a non-penetrating tissue separator 100 without a vertebral head 160 according to some embodiments. Figure 10A The first step of the method is shown, where a distal portion of the non-penetrating tissue separator 100, including at least a portion of the outer shaft 120 and the inner shaft 140 and the grasping element 190, is inserted into a patient and advanced distally towards the patient's heart 10 while the non-penetrating tissue separator 100 is in a first state - in other words, when the grasping element 190 is positioned proximal to the distal lip 126 of the outer shaft.

[0284] When the distal outer edge approaches the heart 10 such that the distal outer edge is at or near the pericardium 14, the operator maneuvers the non-penetrating tissue separator 100 to move the grasping element 190 from the first state to the second state. According to some embodiments, the grasping element 190 is positioned in the second state such that the grasping element 190 is distally spaced from the distal lip 126 of the outer shaft (see Figure 10B ).

[0285] The grasping element 190 is advanced distally to contact the pericardium 14. When the grasping element 190 is at the pericardium 14, the operator maneuvers the non-penetrating tissue separator 100 to rotate the grasping element 190 about the central axis of the grasping element 190.

[0286] During the rotational movement of the grasping element 190, the surface features 188 cause tissue, as Figure 10B shown, to wrap around the grasping element 190 without being cut or pierced by the surface features. Once the tissue of the pericardium 14 is wrapped around the grasping element 190, the operator maneuvers the non-penetrating tissue separator 100 to pull the grasping element 190 in the proximal direction, thereby creating a working pericardial space 16 (see Figure 10C ).

[0287] According to some embodiments, the grasping element 190 is pulled in the proximal direction 94 until the pericardium 14 wrapped around the grasping element 190 is squeezed between the grasping element 190 and at least a portion of the outer shaft 120, thereby locking the wrapped pericardial tissue 14 between the grasping element 190 and the at least a portion of the outer shaft 120.

[0288] According to some embodiments, the outer diameter of the wrapped pericardial tissue 14 is greater than the inner diameter of the outer shaft lumen 132 such that upon retraction, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal lip 126 of the outer shaft, as Figure 10C shown. According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element and the inner surface 130 of the outer shaft.

[0289] It will be appreciated that Figures 10A to 10C the outer shaft 120 shown in Figures 7A to 7C can be the outer shaft 120 from Figures 9A to 9B or the outer shaft 120 from a or the outer shaft 120 from Figures 10A to 10C in any of the embodiments of b According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element and the distal tapered portion 136 of the outer shaft a therebetween. According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal tapered portion 136 of the outer shaft a therebetween.

[0290] According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element and the distal slot 135 of the outer shaft b therebetween. According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal slot shoulder 137 of the outer shaft b therebetween.

[0291] According to some embodiments, the axially slidable movement between the inner shaft 140 and the outer shaft 120 is facilitated by the engagement between the internal threads of the outer shaft thread portion 134 along at least a portion of the inner surface 130 of the outer shaft and the mating external threads of the inner shaft thread portion 154 along at least a portion of the outer surface 148 of the inner shaft.

[0292] According to some embodiments, the relative axial movement between the inner shaft 140 and the outer shaft 120 is facilitated by the engagement between the internal steering knob threads 114 along at least a portion of the inner bore 112 of the steering knob and the mating external threads of the inner shaft thread portion 154 along at least a portion of the outer surface 148 of the inner shaft.

[0293] Now refer to Figures 11A to 11B . Figure 11A and Figure 11B constitute cross-sectional side views of a non-penetrating tissue separator 100 in a first state and a second state, respectively, according to some embodiments. c Figure 12A and Figure 12BComprising a non-penetrating tissue separator 100 according to some embodiments d Cross-sectional side views in a first state and a second state, respectively. Figure 13A and Figure 13B Comprising a non-penetrating tissue separator 100 according to some embodiments e Cross-sectional side views in a first state and a second state, respectively. Figure 14A and Figure 14B Comprising a non-penetrating tissue separator 100 according to some embodiments f Cross-sectional side views in a first state and a second state, respectively.

[0294] Non-penetrating tissue separator 100 c Similar to the non-penetrating tissue separator 100 described in any other embodiment throughout the present specification, except that the inner shaft 140 c and the outer shaft 120 c The relative axial movement between them is facilitated by the threaded engagement between the inner shaft 140 c and the outer shaft 120 c between them.

[0295] According to some embodiments, the threaded engagement between the inner shaft 140 c and the outer shaft 120 c includes the engagement between the internal threads of the outer shaft threaded portion 134 along at least a portion of the proximal portion 122 of the outer shaft c and the mating external threads of the inner shaft threaded portion 154 along at least a portion of the outer surface 148 of the inner shaft c c c

[0296] According to some embodiments, the proximal portion 122 of the outer shaft c includes the outer shaft threaded portion 134 along at least a portion of the inner surface 130 of the proximal portion 122 of the outer shaft c c and a portion of the outer surface 148 of the inner shaft c includes a mating inner shaft threaded portion 154 c such that the inner shaft 140 c is threadedly engaged with the outer shaft 120 c c In such an embodiment, the rotation of the inner shaft 140 in one direction is converted into the axial movement of the inner shaft 140 c relative to the outer shaft 120 in the distal direction 92, thereby causing the position of the grasping element 190 to translate distally in the direction 92. c c

[0297] ​​​​​​​According to some embodiments, the inner shaft 140 c is fixedly connected to the steering knob 110 c 。According to some embodiments, the inner shaft 140 c is fixedly connected to the inner bore 112 of the steering knob c 。In such an embodiment, rotation of the steering knob 110 c in one direction can cause the inner shaft 140 c to rotate with the steering knob 110 c and axially translate relative to the outer shaft 120 c in the distal direction 92, thereby causing the position of the grasping element 190 to translate distally in the direction 92.

[0298] According to some embodiments, the outer shaft 120 c is connected to the handle 102 c 。According to some embodiments, the outer shaft 120 c is fixedly attached to the handle 102 c 。According to some embodiments, the outer shaft 120 c is immovable or stationary relative to the handle 120 c 。According to some embodiments, the proximal portion 122 of the outer shaft c is fixedly attached to the distal portion 106 of the handle, such as by gluing, welding, etc. c 。In such an embodiment, the displacement of the grasping element 190 from the first state to the second state is facilitated by causing the inner shaft 140 c to move axially relative to the outer shaft 120 c in the distal direction.

[0299] According to some embodiments, the outer shaft 120 c is capable of axially sliding within the bore of the handle 102 c 。According to some embodiments, the outer shaft 120 c is capable of axially sliding within the bore of the distal portion 106 of the handle c 。In such an embodiment, the displacement of the grasping element 190 from the first state to the second state is facilitated by causing the outer shaft 120 c to move axially relative to the inner shaft 140 c in the proximal direction.

[0300] The non-penetrating tissue separator 100 d is similar to the non-penetrating tissue separator 100 described in any other embodiment throughout the present specification, except that the axially slidable movement between the inner shaft 140 d and the outer shaft 120 d is along the distal portion 124 of the outer shaft dAt least a portion of the outer shaft threaded portion 134 d The inner thread is connected to the inner shaft distal portion 144 d At least a portion of the inner shaft threaded portion 154 d The engagement between the matching external threads is promoted.

[0301] According to some embodiments, the outer shaft distal portion 124 d The distal portion 124 of the outer shaft includes d The inner surface 130 d At least a portion of the outer shaft threaded portion 134 d , and the inner shaft distal portion 144 d The inner shaft includes a distal portion 144 d The outer surface 148 d At least a portion of the mating inner shaft threaded portion 154 d , so that the inner shaft 140 d With external shaft 120 d In such an embodiment, the inner shaft 140 d The rotation in one direction is converted into an inner shaft 140 d Relative to the outer axis 120 c Axial movement in distal direction 92 causes the position of grasping element 190 to translate distally along direction 92 .

[0302] According to some embodiments, the inner shaft 140 d Fixedly connected to the steering knob 110 d According to some embodiments, the inner shaft 140 d Fixedly connected to the inner hole 112 of the steering knob d In such an embodiment, the steering knob 110 d Rotation in one direction may cause the inner shaft 140 to d With steering knob 110 d rotates together and relative to the outer shaft 120 d Axially translated in distal direction 92 , thereby causing the position of grasping element 190 to translate distally in direction 92 .

[0303] According to some embodiments, the outer shaft 120 d Connect to handle 102 d According to some embodiments, the outer shaft 120 d Fixedly attached to handle 102 d According to some embodiments, the outer shaft 120 d Relative to handle 120 d According to some embodiments, the outer shaft proximal portion 122 dFixedly attached to the distal portion 106 of the handle, for example, by gluing, welding, etc. d . In such an embodiment, the shift of the grasping element 190 from the first state to the second state is achieved by causing the inner shaft 140 d to axially move relative to the outer shaft 120 d in the distal direction.

[0304] According to some embodiments, the outer shaft 120 d is capable of axially sliding within the bore of the handle 102 d . According to some embodiments, the outer shaft 120 d is capable of axially sliding within the bore of the distal portion 106 of the handle d . In such an embodiment, the shift of the grasping element 190 from the first state to the second state is achieved by causing the outer shaft 120 d to axially move relative to the inner shaft 140 d in the proximal direction.

[0305] The non-penetrating tissue separator 100 e is similar to the non-penetrating tissue separator 100 described in any other embodiment throughout the present specification, except that the handle 102 e does not have the first handle recess 108, and the axial slidable movement between the inner shaft 140 e and the outer shaft 120 e is facilitated by the engagement between the internal thread of the steering knob thread portion 114 e along at least a portion of the inner bore 112 of the steering knob e and the mating external thread of the inner shaft thread portion 154 e along at least a portion of the proximal portion 142 of the inner shaft e .

[0306] According to some embodiments, the steering knob 110 e is provided at or near the proximal portion 102 of the handle e . According to some embodiments, the steering knob 110 e includes the inner bore 112 of the steering knob e , the size of which is set to receive the inner shaft 140 e extending through the inner bore 112 of the steering knob e . According to some embodiments, the inner bore 112 of the steering knob e includes the steering knob thread portion 114 e , and the outer surface 148 e of the proximal portion 142 of the inner shaft e ... e ... eA portion of which includes mating inner shaft threaded portion 154 e such that inner shaft 140 e is threadedly engaged with steering knob 110 e In such an embodiment, rotation of steering knob 110 e in one direction can cause inner shaft 140 e to axially translate relative to handle 102 e in the distal direction 92, thereby causing the position of grasping element 190 to translate distally in direction 92.

[0307] According to some embodiments, outer shaft 120 e is connected to handle 102 e According to some embodiments, outer shaft 120 e is fixedly attached to handle 102 e According to some embodiments, outer shaft 120 e is immovable or fixed relative to handle 120 e According to some embodiments, outer shaft proximal portion 122 e is fixedly attached to handle distal portion 106 e such as by gluing, welding, etc. In such an embodiment, the displacement of grasping element 190 from the first state to the second state is facilitated by causing inner shaft 140 e to axially move relative to outer shaft 120 e in the distal direction.

[0308] According to some embodiments, outer shaft 120 e is axially slidable within the bore of handle 102 e According to some embodiments, outer shaft 120 e is axially slidable within the bore of handle distal portion 106 e In such an embodiment, the displacement of grasping element 190 from the first state to the second state is facilitated by causing outer shaft 120 e to axially move relative to inner shaft 140 e in the proximal direction.

[0309] Non-penetrating tissue separator 100 f is similar to non-penetrating tissue separator 100 described in any other embodiment throughout the present specification, except that handle 102 f does not have a steering knob 110, and the relative axial movement between inner shaft 140 f and outer shaft 120 f is facilitated by the threaded engagement between inner shaft 140 f and handle 102 f ​

[0310] According to some embodiments, the inner shaft 140 f and the handle 102 f The threaded engagement therebetween includes an external shaft threaded portion 134 along at least a portion of the distal portion 124 of the external shaft f and an internal threaded engagement with a mating external thread along at least a portion of the internal shaft threaded portion 154 along the distal portion 144 of the internal shaft f f f

[0311] According to some embodiments, the distal portion 124 of the external shaft f includes an external shaft threaded portion 134 along at least a portion of the inner surface 130 along the distal portion 124 of the external shaft f and the distal portion 144 of the inner shaft f includes a mating internal shaft threaded portion 154 along at least a portion of the outer surface 148 along the distal portion 144 of the inner shaft f such that the inner shaft 140 f is threadedly engaged with the external shaft 120 f In such an embodiment, rotation of the inner shaft 140 in one direction is converted into axial movement of the inner shaft 140 relative to the external shaft 120 f in the distal direction 92, thereby causing the position of the grasping element 190 to translate distally in the direction 92 f f f d d f

[0312] According to some embodiments, the external shaft 120 f is connected to the handle 102 f According to some embodiments, the external shaft 120 f is fixedly attached to the handle 102 f According to some embodiments, the external shaft 120 f is immovable or stationary relative to the handle 120 f According to some embodiments, the proximal portion 122 of the external shaft is fixedly attached to the distal portion 106 of the handle, for example, by gluing, welding, etc f f In such an embodiment, the displacement of the grasping element 190 from the first state to the second state is facilitated by axially moving the inner shaft 140 relative to the external shaft 120 f f

[0313] According to some embodiments, the external shaft 120 f is capable of being in the handle 102 f ​​​​​​​​​​​​​axially slide within the bore. According to some embodiments, outer shaft 120 f is capable of axially sliding within the bore of the distal portion 106 of the handle f . In such an embodiment, the displacement of the grasping element 190 from the first state to the second state is facilitated by axially moving the outer shaft 120 f relative to the inner shaft 140 f in the proximal direction.

[0314] It will be appreciated that the axial movement between the inner shaft 140 and the outer shaft 120 throughout the specification can be a two-way movement, i.e., movement in the distal or proximal direction relative to each other. Similarly, it will be appreciated throughout the specification that whenever a first component can be rotated in a first direction to facilitate distal movement of the same first component or a different second component, the rotation of the first component can also be performed in the opposite direction to facilitate proximal movement of the same first component or a different second component.

[0315] It will be appreciated that any combination of embodiments of the different components of the non-penetrating tissue separator 100 can be available, such as, but not limited to, the separator 100 with or without the steering knob 110, with or without the first handle recess 108, with or without the vertebral head 160, with or without a threaded engagement between the inner shaft 120 and the outer shaft 140, with or without a threaded engagement between the inner shaft 120 and the steering knob 110, and so on.

[0316] Although some of these embodiments illustrate a threaded engagement between the inner shaft 120 and the outer shaft 140 along the proximal portion 122 or the distal portion 124 of the outer shaft, it will be appreciated that such a threaded engagement can be located along any region of the outer shaft 140 and can extend along the entire length of the outer shaft 140.

[0317] According to some embodiments, the inner shaft 140 does not have an inner shaft threaded portion 154 such that the relative axial movement between the inner shaft 140 and the outer shaft 120 is facilitated by pushing the outer shaft 120, for example, in a telescoping manner relative to the outer shaft 120 in the distal direction 92, or alternatively by pulling the outer shaft 120 relative to the inner shaft 140 in the proximal direction 94. According to some embodiments, the inner shaft 140 is further fixedly connected to the steering knob 110, such as the steering knob inner bore 112. In such an embodiment, pushing or pulling the inner shaft 140 in the axial direction can be facilitated by pushing or pulling the steering knob 110.

[0318] Now referring to Figures 15 to 18B . Figure 15 A perspective view of the grasping element 190 according to some embodiments g . Figure 16A and 16BComprising a non-penetrating tissue separator 100 equipped with an outer shaft 120 and a grasping element 190 according to some embodiments g in a cross-sectional side view in a first state and a second state, respectively. Figure 17A and Figure 17B Comprising a non-penetrating tissue separator 100 equipped with an outer shaft 120 a and a grasping element 190 g in a cross-sectional side view in a first state and a second state, respectively. Figure 18A and Figure 18B Comprising a non-penetrating tissue separator 100 equipped with an outer shaft 120 b and a grasping element 190 g in a cross-sectional side view in a first state and a second state, respectively.

[0319] The grasping element 190 g As compared with the grasping element 190 a to 190 e (see Figures 2A to 2F ), the embodiments are different in that, for example, the grasping element 190 g is not disk-shaped but is longer in the axial direction and has the shape of a bolt. According to some embodiments, the disk-shaped shape of the grasping element 190 means that the axial length of the grasping element is shorter than the outer diameter of the grasping element. According to some embodiments, the disk-shaped shape of the grasping element 190 means that the axial length of the grasping element is shorter than the outer radius of the grasping element. According to some embodiments, the elongated shape of the grasping element 190 means that the axial length of the grasping element is equal to or longer than the outer diameter of the grasping element.

[0320] Figure 15 Shows a grasping element 190 provided with surface features 188 in the form of radially extending portions g which are provided along the circumferential surface 198 of the grasping element g and project distally from the circumferential surface 198 of the grasping element g and may be provided along the distal surface 196 of the grasping element g and project distally from the distal surface 196 of the grasping element g According to some embodiments, the surface features 188 g are in the form of blunt teeth, each tooth being provided along an axial bending path between the proximal surface 194 of the grasping element g and the distal surface 196 of the grasping element g without surrounding the circumferential surface 198 of the grasping element g . g

[0321] According to some embodiments, the surface features 188g is formed to create a helical groove between surface features 188 g configured to receive a portion of tissue when tissue such as pericardium 14 is wound along the helical groove.

[0322] Advantageously, relative to the grasping element 190 of the disc-shaped configuration g , the elongate grasping element 190 g provides a larger circumferential surface 198 of the grasping element for winding the pericardium 14 g , thereby providing an improved grasping or engagement between the elongate grasping element 190 g and the pericardium 14.

[0323] According to some embodiments, the grasping element 190 is provided with a non-uniform diameter along the length of the grasping element 190 (illustrated in the embodiment). According to some embodiments, the grasping element 190 tapers between the distal surface 196 of the grasping element and the proximal surface 194 of the grasping element to form a frustoconical profile.

[0324] According to some embodiments, the diameter of the distal surface 196 of the grasping element is smaller than the diameter of the proximal surface 194 of the grasping element. According to some embodiments, the diameter of the distal surface 196 of the grasping element is larger than the diameter of the proximal surface 194 of the grasping element.

[0325] According to some embodiments, the outer diameter of the grasping element 190 g is smaller than the diameter of the outer shaft lumen 132 such that the grasping element 190 g can be inserted into the outer shaft lumen 132. In such an embodiment, the distal lip 126 of the outer shaft serves as the distal outer edge. Figure 16A Illustrated is the grasping element 190 g positioned in a first state such that the distal surface 196 of the grasping element 190 g is adjacent to or flush with the distal lip 126 of the outer shaft.

[0326] According to some embodiments, the grasping element 190 and the inner shaft 140 are integrally formed such that the proximal surface 194 of the grasping element is not visible as a separate surface but is continuous with the distal lip of the inner shaft 120.

[0327] According to some embodiments, the grasping element 190 forms the distal portion of the inner shaft 120, for example, by forming a distal region along the inner shaft, the distal region including surface features 188 that include at least one of the distal lip of the inner shaft 120 that constitutes the distal surface 196 of the grasping element in such an embodiment or at least a portion of the circumferential surface 198 of the grasping element that constitutes the inner shaft distal portion 144 in such an embodiment.

[0328] Figure 16B illustrates the grasping element 190 g positioned in a second state, wherein the grasping element 190 g proximal surface 194 g is distally spaced from the distal lip 126 of the outer shaft. According to some embodiments, Figure 16B the second state in is achieved by pushing the inner shaft 140 together with the grasping element 190 g distally relative to the outer shaft 120 in the distal direction 92. According to some embodiments, Figure 16B the second state shown in is achieved by pulling the outer shaft 120 proximally relative to the grasping element 190 g in the proximal direction 94.

[0329] Figures 17A to 17B The outer shaft 120 shown a is similar to Figures 8A to 8B the outer shaft 120 a which includes a distal tapered portion 136 of the outer shaft a . Figure 17A illustrates the grasping element 190 g positioned in a first state such that the grasping element 190 g distal surface 196 g is close to or flush with the distal lip 126 of the outer shaft a or the distal lip 126 of the outer shaft a .

[0330] According to some embodiments, the distal tapered portion 136 of the outer shaft a serves as an inner shaft retraction limiting mechanism such that at least a proximal portion of the distal tapered portion 136 of the outer shaft a has a tapered diameter smaller than the outer diameter of the grasping element 190 g . Thus, the distal tapered portion 136 of the outer shaft a is configured to receive the grasping element 190 g in the distal tapered portion 136 of the outer shaft a while preventing the grasping element 190 g from further retracting proximally when the grasping element 190 a engages the inner surface of the distal tapered portion 136 of the outer shaft g .

[0331] Figure 17B illustrates the grasping element 190 g positioned in a second state, wherein the grasping element 190 g proximal surface 194 g is distally spaced from the distal lip 126 of the outer shaft a According to some embodiments,Figure 8B The second state shown in is achieved by pushing the inner shaft 140 together with the grasping element 190 g relative to the outer shaft 120 a in the distal direction 92. According to some embodiments, Figure 17B the second state shown in is achieved by pulling the outer shaft 120 a relative to the grasping element 190 g in the proximal direction 94.

[0332] Figures 18A to 18B The illustrated outer shaft 120 b is similar to Figures 9A to 9C the outer shaft 120 b and includes an outer shaft distal slot 135 b . Figure 18A Illustrated is the grasping element 190 g positioned in the first state such that the distal surface 196 g of the grasping element 190 g is close to or flush with the outer shaft distal lip 126 b or the outer shaft distal lip 126 b . The outer diameter of the grasping element 190 g is less than the diameter of the inner diameter of the outer shaft distal slot 135 b and greater than the inner diameter of the remainder of the outer shaft lumen 132 b .

[0333] According to some embodiments, the axial length of the outer shaft distal slot 135 b defined between the outer shaft distal lip 126 b and the outer shaft distal slot shoulder 137 b is equal to or greater than the axial length of the grasping element 190 g defined between the grasping element distal surface 196 g and the grasping element proximal surface 194 g , and this axial length is configured to accommodate the grasping element 190 g in this axial length in the first state.

[0334] According to some embodiments, the outer shaft distal slot shoulder 137 b serves as an inner shaft retraction limiting mechanism such that when the grasping element proximal surface 194 g abuts or engages the outer shaft distal slot shoulder 137 b , further proximal retraction of the grasping element 190 g is prevented.

[0335] Figure 18B Illustrated is the grasping element 190 gPositioned in the second state, wherein the grasping element 190 g has a proximal surface 194 g that is distally spaced from the distal lip 126 of the outer shaft b . According to some embodiments, Figure 18B the second state shown in g is achieved by pushing the inner shaft 140 together with the grasping element 190 b distally relative to the outer shaft 120 along the distal direction 92. According to some embodiments, Figure 18B the second state shown in b is achieved by pulling the outer shaft 120 g proximally relative to the grasping element 190.

[0336] Now refer to Figures 19A to 19C , which depicts different steps of a method of using a non-penetrating tissue separator 100 equipped with an elongate grasping element 190 g . Figure 19A shows the first step of the method, wherein a distal portion of the non-penetrating tissue separator 100 including at least a portion of the outer shaft 120 and the inner shaft 140 and the elongate grasping element 190 g is inserted into a patient and advanced distally toward the patient's heart 10 while the non-penetrating tissue separator 100 is in the first state - in other words, when the elongate grasping element 190 g is positioned proximal to the distal lip 126 of the outer shaft.

[0337] When the distal outer edge approaches the heart 10 such that the distal outer edge is at or near the pericardium 14, the operator maneuvers the non-penetrating tissue separator 100 to move the elongate grasping element 190 g from the first state to the second state. According to some embodiments, the elongate grasping element 190 g is positioned in the second state such that the elongate grasping element 190 g is distally spaced from the distal lip 126 of the outer shaft (see Figure 19B ).

[0338] The elongate grasping element 190 g is advanced distally in the second state to contact the pericardium 14. When the elongate grasping element 190 g is at the pericardium 14, the operator maneuvers the non-penetrating tissue separator 100 to rotate the elongate grasping element 190 g about the central axis of the elongate grasping element 190 g .

[0339] While the elongate grasping element 190 gDuring the rotational movement, the surface feature 188 g causes tissue to wrap around the elongated grasping element 190 Figure 19B as shown, without being cut or pierced by the surface feature. Once the tissue of the pericardium 14 wraps around the elongated grasping element 190 g , the operator manipulates the non-penetrating tissue separator 100 to pull the elongated grasping element 190 g in the proximal direction, thereby creating a working pericardial space 16 (see g ). Figure 19C )

[0340] According to some embodiments, the elongated grasping element 190 g is pulled in the proximal direction 94 until the wrapped pericardium 14 along the elongated grasping element 190 g is squeezed between the elongated grasping element 190 g and at least a portion of the outer shaft 120, thereby locking the wrapped pericardial tissue 14 between the elongated grasping element 190 g and the at least a portion of the outer shaft 120.

[0341] According to some embodiments, the outer diameter of the wrapped pericardial tissue 14 is greater than the inner diameter of the outer shaft lumen 132 such that upon retraction, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element g and the distal lip 126 of the outer shaft, as Figure 19C shown. According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element g and the inner surface 130 of the outer shaft.

[0342] It will be appreciated that Figures 19A to 19C the outer shaft 120 shown in Figures 16A to 16B can be the outer shaft 120 from Figures 17A to 17B , the outer shaft 120 from a or the outer shaft 120 from Figures 18A to 18B of any one of the embodiments in b . According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element g and the distal tapered portion 136 of the outer shaft a during retraction. According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element g and the distal tapered portion 136 of the outer shaft a during retraction.

[0343] According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping elementg and the distal slot 135 of the outer shaft b therebetween. According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element g and the distal slot shoulder 137 of the outer shaft b therebetween.

[0344] Now refer to Figures 20A to 20B . Figure 20A and Figure 20B constitute a cross-sectional side view of a non-penetrating tissue separator 100 equipped with an outer shaft 120 h and a grasping element 190 attached to the inner shaft 140 h in a first state and a second state, respectively. g

[0345] According to some embodiments, the distal portion 124 of the outer shaft h includes an outer shaft thread portion 134 along at least a portion of the inner surface 130 h of the distal portion 124 of the outer shaft d , and the distal portion 144 of the inner shaft h includes a mating inner shaft thread portion 154 along at least a portion of the outer surface 148 h of the distal portion 144 of the inner shaft h , such that the inner shaft 140 h is threadedly engaged with the outer shaft 120 h . According to some embodiments, the outer shaft thread portion 134 h extends proximally from the distal lip 126 of the outer shaft h . According to some embodiments, the inner shaft thread portion 154 h extends proximally from the interface where the inner shaft thread portion 154 h is connected to the grasping element 190 h (see g ). Figures 20A to 20B )

[0346] According to some embodiments, the rotation of the inner shaft 140 h in one direction is converted into an axial movement of the inner shaft 140 h relative to the outer shaft 120 h in the distal direction 92, thereby causing the position of the grasping element 190 g to translate distally along the direction 92.

[0347] According to some embodiments, the outer diameter of the grasping element 190 g is substantially equal to the outer diameter of the inner shaft thread portion 154 h . According to some embodiments, the inner shaft thread portion 154h has an outer diameter greater than that of the grasping element 190 g of the outer diameter. According to some embodiments, the grasping element 190 g and the inner shaft threaded portion 154 h are constructed such that tissue such as the pericardium 14, when wrapped around the grasping element 190 g is capable of further wrapping around at least a portion of the inner shaft threaded portion 154 g during continued rotation of the grasping element 190 h and the inner shaft threaded portion 154 h .

[0348] Advantageously, the total length of the grasping element 190 g and the inner shaft threaded portion 154 h provides a greater surface area along which the pericardium 14 can be wrapped, thereby providing improved grasping or engagement between the pericardium 14 and the surface.

[0349] Figure 20A Illustrates the grasping element 190 g positioned in a first state such that the distal surface 196 g of the grasping element 190 g is adjacent to or flush with the distal lip 126 of the outer shaft h or the distal lip 126 of the outer shaft h .

[0350] Figure 20B Illustrates the grasping element 190 g positioned in a second state, wherein the proximal surface 194 g of the grasping element 190 g is distally spaced from the distal lip 126 of the outer shaft h and wherein at least a portion of the inner shaft threaded portion 154 h also extends distally beyond the distal lip 126 of the outer shaft h .

[0351] Now referring to Figures 21A to 21C , which depicts various steps of a method of using a non-penetrating tissue dissector 100 equipped with an outer shaft 120 h and a grasping element 190 attached to an inner shaft 140 h according to some embodiments. g Figure 21A Shows a first step of the method, wherein the outer shaft 120 h and the inner shaft 140 h and at least a portion of the elongate grasping element 190 g ​The distal portion of the non-penetrating tissue separator 100 is inserted into the patient's body and advanced distally toward the patient's heart 10 when the non-penetrating tissue separator 100 is in the first state - in other words, when the elongated grasping element 190 g is positioned proximal to the distal lip 126 of the outer shaft h .

[0352] When the distal outer edge approaches the heart 10 such that the distal outer edge is at or near the pericardium 14, the operator manipulates the non-penetrating tissue separator 100 to move the elongated grasping element 190 h from the first state to the second state. According to some embodiments, the elongated grasping element 190 h is positioned in the second state such that the elongated grasping element 190 h is distally spaced from the distal lip 126 of the outer shaft h , and such that a portion of the inner shaft threaded portion 154 h also extends distally beyond the distal lip 126 of the outer shaft h (see Figure 21B ).

[0353] The elongated grasping element 190 g is advanced distally to contact the pericardium 14. When the elongated grasping element 190 g is located at the pericardium 14, the operator manipulates the non-penetrating tissue separator 100 to cause the elongated grasping element 190 g to rotate about the central axis of the elongated grasping element 190 g .

[0354] During the rotational movement of the elongated grasping element 190 g , the surface features 188 g cause tissue to wrap around the elongated grasping element 190 g without being cut or pierced by the surface features. According to some embodiments, further rotation of the inner shaft 140 h together with the elongated grasping element 190 g causes the tissue of the pericardium 14 to further wrap along the entire length of the grasping element 190 g and along a portion of the length of the inner shaft threaded portion 154 h , as Figure 21B shown.

[0355] Once the tissue of the pericardium 14 is wrapped around the elongated grasping element 190 g and possibly along the inner shaft threaded portion 154 h , the operator manipulates the non-penetrating tissue separator 100 to move the elongated grasping element 190g Pulled in the proximal direction to create a working pericardial space 16 (see Figure 21C ).

[0356] According to some embodiments, the elongate grasping element 190 g and the inner shaft threaded portion 154 h are pulled in the proximal direction 94 until the pericardium 14 wrapped around the elongate grasping element 190 g and the inner shaft threaded portion 154 h is squeezed between the elongate grasping element 190 g and at least a portion of the outer shaft 120, thereby locking the wrapped pericardial tissue 14 between the elongate grasping element 190 g and the said at least a portion of the outer shaft 120.

[0357] According to some embodiments, the elongate grasping element 190 g and the inner shaft threaded portion 154 h are pulled in the proximal direction 94 until the pericardium 14 wrapped around the elongate grasping element 190 g and the inner shaft threaded portion 154 h is squeezed between the inner shaft threaded portion 154 h and at least a portion of the outer shaft 120, thereby locking the wrapped pericardial tissue 14 between the inner shaft threaded portion 154 h and the said at least a portion of the outer shaft 120.

[0358] According to some embodiments, the outer diameter of the wrapped pericardial tissue 14 is greater than the inner diameter of the outer shaft lumen 132, such that upon retraction, the wrapped pericardial tissue 14 is squeezed between a portion of the inner shaft threaded portion 154 h and the outer shaft distal lip 126 h . According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the inner shaft threaded portion 154 h and the outer shaft threaded portion 134 h .

[0359] According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the grasping element circumferential surface 198 g and the outer shaft inner surface 130 h . According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the grasping element circumferential surface 198 g and the outer shaft threaded portion 134 h .

[0360] According to some embodiments, the non-penetrating tissue separator 100 is equipped with an outer shaft 120 h and attached to the inner shaft 140 hThe disc-shaped grasping element 190 (such as the grasping element 190 a through 190 e )(not shown in the embodiment). In such an embodiment, the disc-shaped grasping element 190 is configured to grasp the tissue 14 during rotation of the disc-shaped grasping element 190 and facilitate winding of the tissue 14 around the disc-shaped grasping element 190, and further facilitate winding of the tissue along at least a portion of the length of the inner shaft thread portion 154 h during further rotation. Except that the length of the disc element 190 is shorter than the length of the elongate grasping element 190 g , the structures, operations, and all embodiments described for Figures 20A to 21C are similarly applicable.

[0361] Now refer to Figures 22A to 25 . Figure 22A A perspective view of a non-penetrating tissue separator 100 according to some embodiments i . Figure 22B and Figure 22C constitute cross-sectional side views of the non-penetrating tissue separator 100 i in a first state and a second state, respectively.

[0362] According to some embodiments, the non-penetrating tissue separator 100 i includes a latch mechanism configured to shift the relative axial position between the outer shaft 120 i and the inner shaft 140 i between a first state and a second state.

[0363] According to some embodiments, the latch mechanism includes a rod 156 pivotally movable about a pivot 157, a rod support body 158 including the pivot 157, and a grooved element 138 including at least two axially spaced grooves 139 - such as a distal groove 139a and a proximal groove 139b. Each groove 139 is configured to receive an end portion of the rod 156.

[0364] According to some embodiments, the grooved element 138 is fixedly attached to the handle 102 i , for example, attached to the distal portion 106 of the handle i . According to some embodiments, the rod support body 158 is fixedly attached to the outer shaft 120 i , for example, attached to the outer surface 128 of the outer shaft i . According to some embodiments, the rod support body 158 is fixedly attached to the distal portion 124 of the outer shaft i .

[0365] According to some embodiments, the grooved element 138 is fixedly attached to the handle 102 i, such as being attached to the distal portion 106 of the handle i . According to some embodiments, the grooved element 138 includes a bore through which the inner shaft 140 i can extend axially.

[0366] . According to some embodiments, the latch mechanism further includes a knob 118 that is connected to an end of the rod 156 opposite the end where it engages with the groove 139 of the grooved element 138. According to some embodiments, the latch mechanism further includes a knob spring 119 disposed between the knob 118 and the rod support body 158.

[0367] . According to some embodiments, the rod support body 158 includes a first portion attached to the outer surface 128 of the outer shaft i and a second portion radially spaced from the outer surface 128 of the outer shaft i , and the two portions are connected to each other via an intermediate shoulder. According to some embodiments, the first portion of the rod support body 158 is formed as a cylinder attached around the outer surface 128 of the outer shaft i . According to some embodiments, the second portion of the rod support body 158 is formed as a cylinder configured to cover at least a portion of the grooved element 138 when positioned in at least one of a first state and a second state.

[0368] . According to some embodiments, the intermediate shoulder of the rod support body 158 includes a pivot 157. According to some embodiments, the knob spring 119 is disposed between the knob 118 and the first portion of the rod support body 158 (see Figures 22B to 22C ).

[0369] Figure 22B shows the non-penetrating tissue separator 100 i in a first state, in which the grasping element 190 is positioned proximal to the distal lip 174 of the vertebral body a . The rod 156 is spring-biased into the distal groove 139a via the spring 119. Since the rod 156 is attached to the outer surface 128 of the outer shaft via the pivot 157 and the rod support body 158 i , as long as the rod 156 remains in place, the rod 156 will prevent the outer shaft 120 i and the vertebral head 160 attached to the outer shaft 120 i from moving axially relative to the handle 102 a . If the inner shaft 140 i also remains stationary relative to the handle 102 i , the grasping element 190 remains positioned in the first state. i

[0370] Push the knob 118 to contract the knob spring 119 to pivot the rod about the pivot 157, thereby releasing the rod 156 from the distal groove 139a and causing the outer shaft 120 i to be axially displaceable relative to the handle 102 i . The outer shaft 120 i can be retracted in the proximal direction 94 to expose the grasping element 190, i.e., position the grasping element 190 in the second state. Then, the knob 118 can be released so that the rod 156 can engage the proximal groove 139b.

[0371] Figure 22C The non-penetrating tissue separator 100 is shown i in the second state, where the grasping element 190 is positioned distal to the vertebral body distal lip 174 a . The rod 156 is spring-biased into the proximal groove 139b via the spring 119. Since the rod 156 is attached to the outer shaft outer surface 128 via the pivot 157 and the rod support body 158 i , as long as the rod 156 remains in place, the rod 156 will prevent the outer shaft 120 i and the vertebral body head 160 attached thereto a from axially moving relative to the handle 102 i . If the inner shaft 140 i also remains stationary relative to the handle 102 i , the grasping element 190 remains positioned in the second state.

[0372] When engaged with the rod 156, the axial position of the distal groove 139a is configured to position the grasping element 190 in the first state. When engaged with the rod 156, the axial position of the proximal groove 139b is configured to position the grasping element 190 in the second state.

[0373] Although Figures 22A to 22C the embodiment of the non-penetrating tissue separator 100 shown i includes the vertebral body head 160 a , it will be apparent that any other vertebral body head 160 can be attached to the outer shaft 120 i , and the outer shaft 120 i can also be provided in a configuration without the vertebral body head 160.

[0374] Similar to Figures 22A to 22C the view of Figures 23A to 23C shows other embodiments of the non-penetrating tissue separator 100 i , where the second portion of the rod support body 158 b includes the pivot 157 b . In this exemplary embodiment, the knob 118b Positioned along the second part of the rod support body 158 b and the knob handle spring 119 b is disposed within the knob handle 118 b and an internal support within the second part of the rod support body 158 b such that the internal support may be formed as an axial extension of the first part of the rod support body 158 (see b ). Figures 23A to 23B )

[0375] According to some embodiments, the handle 102 i includes a first handle recess 108 i and a steering knob 110 disposed within the first handle recess 108 i . According to some embodiments, the steering knob 110 i includes a steering knob inner bore 112 i which is configured to receive an inner shaft 140 extending along the steering knob inner bore 112 i such that the inner shaft 140 i is configured to axially move through the steering knob inner bore 112 i . i i i

[0376] According to some embodiments, the inner shaft 140 i is configured to act axially within the steering knob inner bore 112 via a roller bearing 146 attached to the inner shaft 140 i . i Figure 24A A perspective view of the inner shaft 140 with two roller bearings 146a and 146b is shown, and the roller bearings 146a and 146b may be formed as wheels, rollers, etc. i Figure 24B Constructed Figure 24A Cross-sectional view in the direction 24B - 24B. The rod portions 145a and 145b connect the roller bearings 146a and 146b to the inner shaft 140 i .

[0377] Figure 25 Constructed as a cross-sectional view observed from the direction 25 - 25 of Figure 23C . The roller bearing 146 is configured to roll along the edge of the steering knob inner bore 112 i thereby effecting axial movement of the inner shaft 140 i .

[0378] According to some embodiments, the inner shaft 140 i includes means for facilitating or allowing the inner shaft 140 i ​​​​​Within the inner bore 112 of the steering knob i and along the inner bore 112 of the steering knob i axially move other components, such as a flat sliding bearing (not shown in the embodiment).

[0379] According to some embodiments, the inner shaft 140 i is configured to slide along the inner bore 112 of the steering knob i while there is no intermediate component between the inner shaft 140 i and the inner bore 112 of the steering knob i For example, the outer surface 148 of the inner shaft i may be provided with a lubricated or low-friction surface (not shown in the embodiment).

[0380] The roller bearings 146a and 146b are superior to other solutions because the roller bearings 146a and 146b can help provide a smoother movement of the inner shaft 140 i along the inner bore 112 of the steering knob i

[0381] According to some embodiments, the inner bore 112 of the steering knob i has an elongated profile (see Figure 25 ), wherein the height is configured to closely match the diameter of the roller bearing 146, and wherein the width of the inner bore 112 of the steering knob i is configured to accommodate the roller bearings 146a, 146b and their respective rod portions 145a, 145b.

[0382] According to some embodiments, the steering knob 110 i includes a steering knob axially extending portion 111 i , such as a distal steering knob axially extending portion 111 i a and a proximal steering knob axially extending portion 111 i b, which extend towards a mating slot in the distal axial sidewall of the first handle recess 108 i .

[0383] According to some embodiments, the proximal sidewall and the distal sidewall of the first handle recess 108 i include an inner axial hole, which is configured to allow the inner shaft 140 i to pass through the inner axial hole. According to some embodiments, the steering knob 110 i is capable of rotating within the first handle recess 108 i about the central axis of the steering knob 110 i . According to some embodiments, the steering knob 110 i is via bearings, such as sliding bearings 113 i and 155​i Connected to the first handle recess 108 i of the distal side wall and the proximal side wall.

[0384] In Figures 22B to 22C and Figures 23B to 23C In an exemplary embodiment, the distal sliding bearing 113 i a is disposed between the distal steering knob axial extension 111 i a and a mating slot within the distal side wall of the first handle recess 108 i The proximal sliding bearing 113 i b is disposed between the proximal steering knob axial extension 111 i b and a mating slot within the proximal side wall of the first handle recess 108 i The distal sliding bearing 155 i a is disposed between the distal steering knob axial extension 111 i a and an inner axial hole within the distal side wall of the first handle recess 108 i And the proximal sliding bearing 155 i b is disposed between the proximal steering knob axial extension 111 i b and an inner axial hole within the proximal side wall of the first handle recess 108 i of.

[0385] The sliding bearings 113 i a, 113 i b, 155 i a and 155 i b can help provide a smoother rotational movement of the steering knob 110 i within the first handle recess 108 i According to some embodiments, other types of bearings may be provided between the steering knob 110 i and other structural components of the handle 102 i such as roller bearings (embodiments not shown). According to some embodiments, the steering knob 110 i is configured to rotate within the first handle recess 108 i without any intermediate components with respect to other structural components of the handle 102 i For example, the steering knob axial extension 111 i may be provided with a lubricated or smooth low friction surface (embodiments not shown).

[0386] According to some embodiments, the handle 102 i further includes a second handle recess 109 i which is configured such that an extension passes through the second handle recess 109 i ​i The inner shaft 140 i At least a portion of which can be visually exposed. According to some embodiments, the second handle recess 109 i Is provided in the first handle recess 108 i Between the near side wall of the first handle recess 108 and the handle proximal portion 104 i Although Figures 22A to 23C The second handle recess 109 in the illustrated embodiment in i Is positioned proximal to the first handle recess 108 i However, according to some embodiments, the second handle recess 109 i Can be positioned distal to the first handle recess 108 (embodiment not shown). i

[0387] According to some embodiments, the handle proximal portion 104 i Includes an inner proximal hole that extends from the handle inlet 107 at the proximal edge of the handle 102 i To the second handle recess 109 i And is configured to allow the inner shaft 140 i To pass through the inner proximal hole. i

[0388] According to some embodiments, the non-penetrating tissue separator 100 i Further includes at least one shaft spring configured to provide resistance to proximal displacement of the inner shaft 140, such as a first shaft spring 116 disposed between the inner shaft 140 i And the handle 102 i i Between the first shaft spring 116.

[0389] According to some embodiments, the first shaft spring 116 is disposed around at least a portion of the inner shaft 140 i Such that one end of the first shaft spring 116 is attached to or abuts a portion of the inner shaft 140 i Or is attached to or abuts an element attached to the inner shaft 140 i And the opposite end of the first shaft spring 116 is attached to or abuts a portion of the handle 102 i

[0390] According to some embodiments, the inner shaft 140 i Includes an inner shaft spring retainer 117 i Which is fixedly attached to the outer surface 148 of the inner shaft i And extends radially outward from the outer surface 148 of the inner shaft i And extends radially outward from the outer surface 148 of the inner shaft i According to some embodiments, the handle proximal portion 104 iincluding a handle spring retainer 103 i , the handle spring retainer 103 i is attached to the inner proximal hole of the handle spring retainer 103 i and extends radially inwardly from the inner proximal hole (see Figures 22B to 22C ). According to some embodiments, a first shaft spring 116 is disposed between an inner shaft spring retainer 117 i and the handle spring retainer 103 i .

[0391] According to some embodiments, at least a portion of the shaft spring 116 is disposed along a portion of the inner shaft 140 i visible through the second handle recess 109 i .

[0392] According to some embodiments, the inner shaft 140 i does not have an inner shaft spring retainer 117 i , and the first shaft spring 116 is directly attached to the inner shaft 140 i at an end of the first shaft spring 116, for example, attached to the outer surface 148 of the inner shaft i . According to some embodiments, the handle 102 i does not have a handle spring retainer 103 i , and the first shaft spring 116 is directly attached to the handle 102 i at an end of the first shaft spring 116, for example, attached to the inner proximal hole of the proximal portion 104 of the handle i (embodiment not shown).

[0393] According to some embodiments, the first shaft spring 116 is disposed between the proximal edge of the inner shaft 140 i and a portion of the handle 102 i (embodiment not shown).

[0394] According to some embodiments, the first shaft spring 116 is disposed around at least a portion of the inner shaft 140 i such that one end of the first shaft spring 116 is attached to or abuts against a portion of the inner shaft 140 i or is attached to or abuts against an element attached to the inner shaft 140 i , and the opposite end of the first shaft spring 116 is attached to or abuts against the second recess near side wall 159 i a (annotated in Figures 28A to 28C ) (embodiment not shown).

[0395] According to some embodiments, the first shaft spring 116 is disposed around at least a portion of the inner shaft 140 i such that one end of the first shaft spring 116 is attached to or adjacent to the inner shaft 140i or attached to the inner shaft 140 i and an opposite end of the first shaft spring 116 is attached to or adjacent to the second recess distal side wall 159 i b (annotated in Figures 28A to 28C )(not shown in the embodiment).

[0396] According to some embodiments, the non-penetrating tissue separator 100 i includes a marker 105 for indicating at least one of the following: the position where the grasping element 190 is attached to the inner shaft 140 i the force exerted by the grasping element 190 when pressing against an outer surface, such as heart tissue, whether the tissue provides resistance to a proximal pull of the grasping element 190, or whether the tissue has been grasped by the grasping element 190.

[0397] According to some embodiments, the second handle recess 109 i includes a marker 105 for indicating the position where the grasping element 190 is attached to the inner shaft 140 i or the force exerted by the grasping element 190 when pressing against heart tissue. According to some embodiments, the marker 105 includes flags in the following ranges: the flags in the ranges indicate whether the current position or force exerted on the tissue by the grasping element 190 is within a safe or non-contact zone, within a desired safe contact zone, or within a risk-prone zone. According to some embodiments, the marker 105 includes color-coded flags.

[0398] In use, as long as no external force is applied to the inner shaft 140 i and the grasping element 190 attached to the inner shaft 140 i the first shaft spring 116 holds the inner shaft 140 i and the grasping element 190 attached to the inner shaft 140 i in a specific axial position. Once the distal end of the non-penetrating tissue separator 100 i reaches the heart 10 and the non-penetrating tissue separator 100 i switches from the first state to the second state, the operator can manipulate the non-penetrating tissue separator 100 i to bring the grasping element 190 close to the pericardium 14, for example, to ensure sufficient contact between the distal surface 196 of the grasping element and the pericardium 14 before rotating the grasping element 190 to wind the tissue around the grasping element 190.

[0399] It is necessary to ensure sufficient contact between the distal surface 196 of the grasping element and the pericardium 14 while avoiding applying excessive force to the tissue.

[0400] When the grasping element 190 is pressed against heart tissue, such as the pericardium 14, the pressure causes the first shaft spring 116 to contract, causing the inner shaft 140 i to shift in the proximal direction relative to the handle 102 i According to some embodiments, the inner shaft 140 i includes a marking on the outer surface 148 i of the inner shaft 140 i that can be compared to the marker 105 to indicate the position of the grasping element 190 or the force applied by the grasping element 190 on the tissue.

[0401] According to some embodiments, the inner shaft 140 i includes structural features that can be compared to the marker 105 to indicate the position of the grasping element 190 or the force applied by the grasping element 190 on the tissue. According to some embodiments, the inner shaft spring retainer 117 i serves as a structural feature that can be compared to the marker 105. According to some embodiments, the inner shaft spring retainer 117 i includes structural features that can be compared to the marker 105 to indicate the position of the grasping element 190 or the force applied by the grasping element 190 on the tissue.

[0402] According to some embodiments, the structural features of the shaft spring 116 include a metering needle that can be used in conjunction with the marking or marker 105 to indicate the position of the grasping element 190 or the force applied by the grasping element 190 on the tissue.

[0403] According to some embodiments, the structural features of the inner shaft 140 i include a metering needle that can be used in conjunction with the marking or marker 105 to indicate the position of the grasping element 190 or the force it applies on the tissue.

[0404] According to some embodiments, the lid of the handle 102 i includes a metering needle that is accompanied by a marking or marker 105 to indicate the position of the grasping element 190 or the force applied by the grasping element 190 on the tissue.

[0405] According to some embodiments, as long as the grasping element 190 does not apply a sufficient force, i.e., a force exceeding a predetermined value, on the tissue, the marking or structural features of the inner shaft 140 i can be positioned against the area of the marker 105 representing a safe, non-contact position.

[0406] According to some embodiments, when the grasping element 190 is pressed against the heart tissue, the first shaft spring 116 contracts sufficiently such that the marking or structural features of the inner shaft 140 i move proximally to a position against the area of the marker 105 representing a safe contact position.

[0407] According to some embodiments, when the grasping element 190 is pressed too hard against the heart tissue, e.g., in a manner that may damage the tissue, the first axial spring 116 further contracts such that the inner shaft 140 i 's indicia or structural features are further moved in the proximal direction to a position abutting an area of the marker 105 indicating a risk-prone location. Accordingly, the operator can readjust the force applied to the heart tissue.

[0408] According to some embodiments, the handle 102 i includes a lid that is configured to at least cover the second handle recess 109 i , thereby providing environmental protection for the exposed portion of the inner shaft 140 i (embodiment not shown). According to some embodiments, the lid includes the marker 105.

[0409] The characteristics of the at least one axial spring, such as the first axial spring 116, can be selected, such as its size, material, or spring constant k, to provide an appropriate desired resistance for indicating whether the grasping element 190 is pressed against the tissue such that the grasping element 190 applies a moderate or excessive force on the tissue.

[0410] According to some embodiments, the at least one spring, such as the first axial spring 116, is a compression spring (see Figures 22A to 23C ). According to some embodiments, the at least one spring, such as the first axial spring 116, is an expansion spring (embodiment not shown).

[0411] According to some embodiments, a kit is provided that includes the non-penetrating tissue separator 100 and the balloon catheter 40, the balloon catheter 40 being configured to inflate a balloon distal to the non-penetrating tissue separator 100 to ensure easier delivery of the distal region of the non-penetrating tissue separator 100 through a patient's organs and tissues until reaching the patient's heart 10.

[0412] Now refer to Figures 26A to 26B . Figure 26A and Figure 26B constitute a perspective view and a cross-sectional side view of the balloon catheter 40, the balloon catheter 40 having an inflatable balloon 44 distal to the non-penetrating tissue separator 100 i . The balloon catheter 40 includes an inflatable balloon 44 at its distal end. According to some embodiments, the balloon catheter 40 and the balloon 44 are configured to extend through the inner shaft lumen 152 when the balloon 44 is deflated i .

[0413] According to some embodiments, the balloon catheter 40 includes a balloon catheter opening 42 through which a gas or liquid, such as saline or carbon dioxide, can enter the interior volume of the balloon 44 to inflate the balloon 44.

[0414] According to some embodiments, the balloon includes a balloon distal portion 46 and a balloon proximal portion 48. According to some embodiments, the balloon distal portion is designed to be a tapered or dome-shaped atraumatic tip when inflated, which is configured to assist in advancing the balloon 44 together with the distal region of the non-penetrating tissue separator 100 i through the patient's organ including hard tissue without damaging the organ.

[0415] According to some embodiments, the balloon proximal portion 48 is designed to provide a relatively smooth transition between the distal end of the non-penetrating tissue separator 100 i and the balloon 44 when inflated.

[0416] According to some embodiments, when inflated, the outer diameter of the balloon is substantially equal to or greater than the outer diameter of the vertebral body distal lip 174 a .

[0417] Although the balloon catheter 40 and the balloon 44 are shown in combination with the non-penetrating tissue separator 100 Figures 26A to 26B in the exemplary embodiments, it will be apparent that the balloon catheter 40 together with the balloon 44 can be used in combination with any other embodiments or configurations of the non-penetrating tissue separator 100 disclosed throughout the specification. i

[0418] Now referring to Figures 27A to 27D , which depicts different steps of a method of using the non-penetrating tissue separator 100 with the balloon catheter 40 i according to some embodiments. Figure 27A shows the first step of the method, in which the balloon 44 is inflated distally of the distal portion of the non-penetrating tissue separator 100 i and advanced distally towards the patient's heart 10 when the non-penetrating tissue separator 100 i is in a first state - in other words, when the grasping element 190 is positioned proximal to the vertebral body distal lip 174 a and proximal to the inflated balloon 44.

[0419] When the balloon 44 approaches the heart 10, the balloon 44 is deflated and retracted from the non-penetrating tissue separator 100 together with the balloon catheter 40 i . Once the balloon catheter is retracted, the outer shaft 120 i and the inner shaft 140 i ​at least a portion of, the grasping element 190, and the vertebral head 160 a the non-penetrating tissue separator 100 i The distal portion of which can be further advanced to be placed closer to the pericardium 14.

[0420] Then, the operator can manipulate the non-penetrating tissue separator 100 i , to mobilize the grasping element 190 from the first state to the second state, for example, by using a latch mechanism to retract the outer shaft 120 i together with the vertebral head 160 a proximally, thereby exposing the grasping element 190 that is now distally spaced from the distal lip 174 of the vertebra a (see Figure 27B ).

[0421] According to some embodiments, in order to retract the vertebral head 160 a , the operator presses the knob 118 to release the rod from the distal groove 139a, pulls the rod support body 158 together with the rod 156, and then releases the knob 118 to a position where the rod 156 can engage the proximal groove 139b.

[0422] According to some embodiments, once the vertebral head 160 a retracts, the grasping element 190 is positioned in the second state but spaced from the pericardium 14. Then, the operator can manipulate the non-penetrating tissue separator 100 i , to bring the grasping element 190 closer and press the grasping element 190 against the pericardium 14 to ensure sufficient contact between the grasping element 190 and the pericardium 14.

[0423] According to some embodiments, the operator adjusts the amount of pressure applied by the grasping element 190 on the pericardium 14 based on the feedback from the marker 105. Then, the operator manipulates the non-penetrating tissue separator 100 i , to rotate the grasping element 190 about the central axis of the grasping element 190, for example, by rotating the steering knob 110 i .

[0424] During the rotational movement of the grasping element 190, the surface feature 188 causes tissue such as Figure 27B shown to wind around the grasping element 190 without being cut or pierced by the surface feature. Once the tissue of the pericardium 14 winds around the grasping element 190, the operator manipulates the non-penetrating tissue separator 100 i , to, for example, retract the outer shaft 120 i together with the vertebral head 160 aPush distally together to reposition the grasping element 190 from the second state to the first state, i.e., position the grasping element 190 within the vertebral head 160 a thereby locking the wrapped pericardial tissue 14 between the grasping element 190 and the vertebral head 160 a and the outer shaft 120 i at least one of them.

[0425] According to some embodiments, to push the vertebral head 160 a , the operator presses the knob 118 to release the rod from the proximal groove 139b, pushes the rod support body 158 together with the rod 156, and then releases the knob 118 to a position where the rod 156 can engage the distal groove 139a.

[0426] According to some embodiments, the operator manipulates the non-penetrating tissue separator 100 to retract the grasping element 190 in the proximal direction and simultaneously push the vertebral head 160 in the distal direction.

[0427] According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal lip 174 of the vertebra a (not shown in the embodiment). According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the circumferential surface 198 of the grasping element and the inner surface 178 of the vertebra a as shown in Figure 27C and Figure 27D .

[0428] According to some embodiments, the wrapped pericardium 14 is squeezed between the grasping element 190 and at least a portion of the outer shaft 120 i thereby locking the wrapped pericardial tissue 14 between the grasping element 190 and the at least a portion of the outer shaft 120 i . According to some embodiments, the wrapped pericardial tissue 14 is squeezed between the proximal surface 194 of the grasping element and the distal lip 126 of the outer shaft i .

[0429] Once the wrapped pericardium 14 is locked in place, the entire distal portion of the non-penetrating tissue separator 100 i can be pulled proximally to create the working pericardial space 16 (see Figure 27C ).

[0430] Figure 27D Shows a further step of advancing the distal needle portion 24 in the direction 92 to pierce that portion of the pericardium 14 extending along the inner opening 192 of the grasping element to provide access to the pericardial space 16.

[0431] According to some embodiments, asFigure 27D As shown, the distal needle portion 24 cannot extend beyond the distal vertebral lip 174 a —for example, due to the needle limiting element 26 preventing such extension, thereby ensuring that the needle does not cut or pierce any other tissue, such as the epicardium 12.

[0432] According to some embodiments, a needle having a curved or bent distal needle portion 24 can be rotated about its axis to orient the curved or bent distal portion 24 in a desired direction, thereby providing control over the advancement direction of a guide wire 30 passing through the needle.

[0433] Similar to Figures 22A to 22C the view of Figures 28A to 28C shows a non-penetrating tissue separator 100 i Another embodiment of i which has two opposing shaft springs 116 a , such as a first shaft spring 116 a a and a second shaft spring 116 a b. The first shaft spring 116 a a is structurally and functionally similar to the first shaft spring 116 described herein for Figures 22A to 23C . According to some embodiments, the handle 102 i does not have a handle spring retainer 103 i , and the first shaft spring 116 or 116 a a is directly attached to the handle 102 at the end of the first shaft spring 116 or 116 a a, for example, attached to the second recess near side wall 159 i a (see i ). Figures 28A to 28C )

[0434] According to some embodiments, the second shaft spring 116 a b is disposed between the inner shaft 140 i and the handle 102 i , and is configured to provide resistance to distal displacement of the inner shaft 140 i . According to some embodiments, the second shaft spring 116 a b is disposed around at least a portion of the inner shaft 140 i .

[0435] According to some embodiments, the inner shaft 140 i includes two inner shaft spring retainers 117 i a and 117 i a, and these two inner shaft spring retainers 117 i a and 117 iEach of those in a is fixedly attached to the outer surface 148 of the inner shaft i and extends radially outwardly from the outer surface 148 of the inner shaft i According to some embodiments, the first shaft spring 116 a a is disposed between the first inner shaft spring retainer 117 i a and the handle 102 i such as between the first inner shaft spring retainer 117 i a and the proximal sidewall 159 of the second recess i a, while the first shaft spring 116 a b is disposed between the second inner shaft spring retainer 117 i b and the handle 102 i such as between the second inner shaft spring retainer 117 i b and the distal sidewall 159 of the second recess i b.

[0436] According to some embodiments, the second handle recess 109 i includes a first marker 105 a which is configured to indicate proximal displacement of the inner shaft 140 a which indicates the force applied by the inner shaft in the distal direction, and a second marker 150 i which is configured to indicate distal displacement of the inner shaft 140 b which indicates the force applied by the inner shaft in the proximal direction. i

[0437] According to some embodiments, the rod support body 158 c has no second part. According to some embodiments, the first part of the rod support body 158 c is formed as a cylinder which is fixedly attached around the outer surface 128 of the outer shaft i and has a radially extending portion that projects radially outwardly and includes a pivot 157 c . In such an embodiment, the knob 118 c is positioned on the first part of the rod support body 158 c and the knob spring 119 c is disposed between the knob 118 c and the first part of the rod support body 158 c .

[0438] According to some embodiments, the outer shaft 120, the inner shaft 140, the vertebral head 160 and the grasping element 190 are coaxial in a free state which is defined as a state where no external force acts on the vertebral head 160 or the grasping element 190.

[0439] Now refer toFigures 29A to 29B 。 Figures 29A to 29B Comprising a non-penetrating tissue separator 100 equipped with a tiltable vertebral head 160 according to some embodiments b of the distal portions of which are in a non-tilted vertebral state and a cross-sectional side view in a tilted vertebral state respectively. The non-penetrating tissue separator 100 i is positioned near the heart 10 in i in Figure 29A wherein the center line of the vertebral head 160 b coincides with the center line 50 of the outer shaft 120 i . Figure 29A The non-tilted vertebral state of the vertebral head 160 shown b is a state in which the center line 50 of the outer shaft 120 also coincides with the center line of the center line of the vertebral head 160 i and is orthogonal to the anterior plane 52 of the vertebral head defined by the distal vertebral lip 174 b . b In some cases, as

[0440] shown, when the vertebral head 160 approaches the heart 10, the anterior plane 52 of the vertebral head is angled relative to the plane of the pericardium 14 adjacent to the vertebral opening 168b, such that the vertebral head 160 Figure 29A contacts the pericardium 14 along a relatively limited portion around the distal vertebral lip 174 b , for example, along less than 50% of the circumferential length of the distal vertebral lip 174 b . b According to some embodiments, the vertebral head 160 is configured to tilt or bend relative to the outer shaft 120 such that the center line of the vertebral head 160 can be angled relative to the center line of the outer shaft 120. In the tilted or bent vertebral state (as

[0441] shown), the center line of the vertebral head 160 is angled relative to the center line 50 of the outer shaft 120. The bent or tilted vertebral state can be achieved, for example, by bringing the vertebral head 160 closer to the heart wall, thereby applying pressure to the distal vertebral lip 174 Figure 29B .

[0442] According to some embodiments, the vertebral head 160 is pivotally attached to the outer shaft 120 (see Figures 29A to 29B ). According to some embodiments, the proximal vertebral portion 164 is pivotally attached to the distal portion 124 of the outer shaft

[0443] Figure 29B Shows the following embodiment of the cone head 160 b which is relative to the distal portion 124 of the outer shaft iTilting so that the front plane 52 of the vertebral head is now relative to the outer axis 120 i at an angle α with respect to the centerline 50, and the front plane 52 of the vertebral head is substantially aligned with the adjacent plane of the pericardium 14, such that the vertebral head 160 b substantially follows along the entire periphery of the distal lip 174 of the vertebra b to contact the pericardium.

[0444] According to some embodiments, at least a portion of the vertebral head 160, such as the proximal portion 164 of the vertebral body, includes a flexible material to enable it to bend relative to the distal portion 124 of the outer shaft (not shown in the embodiments). According to some embodiments, at least a portion of the vertebral head 160, such as the proximal portion 164 of the vertebral body, includes a shape memory material, such as nitinol.

[0445] According to some embodiments, the non-penetrating tissue separator 100 further includes at least one spring (not shown in the embodiments) at the attachment between the proximal portion 164 of the vertebral body and the distal portion 124 of the outer shaft.

[0446] As used herein, the tilted vertebral state or the bent vertebral state are interchangeable and refer to the state in which the centerline of the vertebral head 160 is at an angle with respect to the centerline of the outer shaft 120.

[0447] According to some embodiments, the vertebral head 160 is configured to transition between an un-tilted vertebral state or an un-bent vertebral state when no external force is applied to the vertebral head 160 and a corresponding tilted vertebral state or bent vertebral state when an external force, such as an external force pressing against the distal surface, is applied.

[0448] Although the vertebral head 160 b is shown in an exemplary embodiment in combination with the non-penetrating tissue separator 100 Figures 29A to 29B it will be apparent that the vertebral head 160 i can be used in combination with any other embodiment or configuration of the non-penetrating tissue separator 100 disclosed throughout the specification. b b

[0449] Now refer to Figures 30 to 33B . Figures 30 to 32 A cross-sectional side view of the distal portion of a non-penetrating tissue separator 100 configured according to some embodiments and equipped with bendable inner shafts 140 j 、140 k and 140 m . Figures 33A to 33B A non-penetrating tissue separator 100 configured according to some embodiments and equipped with a bendable inner shaft 140 m i ​Cross-sectional side views of the distal portions in the unbent shaft state and the bent shaft state, respectively.

[0450] Non-penetrating tissue separator 100 i In Figure 3A is positioned near the heart 10 in the second state, wherein the centerline of the grasping element 190 coincides with the centerline 50 of the outer shaft 120 i of. Figure 33A The inner shaft 140 shown m in the unbent shaft state is a state in which the centerline 50 of the outer shaft 120 i also coincides with the centerline of the grasping element 190 and is orthogonal to the front plane 54 of the grasping element defined by the distal surface 196 of the grasping element.

[0451] In some cases, as Figure 33A shown, when approaching the heart 10, the front plane 54 of the grasping element is angled relative to the plane of the pericardium 14 adjacent to the grasping element 190, such that the grasping element 190 contacts the pericardium 14 along a relatively limited portion around the distal surface 196 of the grasping element, e.g., along less than 50% of the circumferential length of the distal surface 196 of the grasping element.

[0452] According to some embodiments, the distal end of the inner shaft 140 is configured to bend relative to the outer shaft 120 such that the centerline of the grasping element 190 attached to the distal end of the inner shaft 140 can be angled relative to the centerline of the outer shaft 120. In the bent shaft state (as Figure 33B shown), the centerline of the grasping element 190 is angled relative to the centerline 50 of the outer shaft 120. The bent shaft state can be achieved, for example, by moving the grasping element 190 further towards the heart wall, thereby applying pressure to the distal surface 196 of the grasping element.

[0453] According to some embodiments, the inner shaft 140 includes a bendable inner shaft portion 147 and a rigid inner shaft portion 143. The bendable region 147 is a portion of the inner shaft 140 that bends when a force applied to that portion is higher than a first threshold F1. According to some embodiments, the rigid inner shaft portion 143 does not bend when a force higher than the first threshold F1 is applied to the rigid inner shaft portion 143. According to some embodiments, the rigid inner shaft portion 143 does not bend when a force higher than the first threshold F1 but lower than a second threshold F2 is applied to the rigid inner shaft portion 143, and may bend when a force higher than the second threshold F2 is applied to the rigid inner shaft portion 143.

[0454] According to some embodiments, in the second state, the bendable inner shaft portion 147 extends along at least a portion of the inner shaft 140 that is defined within the vertebral head 160 and / or extends distally from the vertebral opening 168. According to some embodiments, in the second state, the bendable inner shaft portion 147 extends along at least a portion of the inner shaft 140 that extends distally from the proximal vertebral portion 164. According to some embodiments, the rigid inner shaft portion 143 extends along the entire length of the inner shaft 140 proximal to the bendable inner shaft portion 147.

[0455] According to some embodiments, the bendable inner shaft portion 147 comprises a material that is more flexible than the material of the rigid inner shaft portion 143. According to some embodiments, the bendable inner shaft portion 147 comprises a spring (not shown in the embodiments). According to some embodiments, the bendable inner shaft portion 147 comprises a plurality of slots or bellows that render the bendable inner shaft portion 147 flexible.

[0456] Figure 30 An embodiment of the inner shaft 140 is shown j which inner shaft 140 j comprises a bendable inner shaft portion 147 that extends proximally from the proximal surface 194 of the grasping element j and a rigid inner shaft portion 143 that extends proximally from the proximal end of the bendable inner shaft portion 147 j j . Figure 30 The bendable inner shaft portion 147 in the exemplary embodiment shown j comprises a material that is more flexible than the material of the rigid inner shaft portion 143 j .

[0457] Figure 30 An embodiment of the inner shaft 140 is shown j which inner shaft 140 j comprises a rigid inner shaft portion 143 k , a bendable inner shaft portion 147 k and a distal rigid shaft portion 149 k . The distal rigid shaft portion 149 k extends proximally from the proximal surface 194 of the grasping element, and the bendable inner shaft portion 147 k extends between the distal rigid shaft portion 149 k and the rigid inner shaft portion 143 k . Figure 31 The bendable inner shaft portion 147 in the exemplary embodiment shown k comprises a material that is more flexible than the material of the rigid inner shaft portion 143 k and the material of the distal rigid shaft portion 149 k . According to some embodiments, the rigid inner shaft portion 143k and a distal rigid shaft portion 149 k comprise the same material.

[0458] Figure 32 shows an inner shaft 140 m of an embodiment, the inner shaft 140 m comprising a bendable inner shaft portion 147 extending proximally from the proximal surface 194 of the grasping element m and a rigid inner shaft portion 143 extending proximally from the proximal end of the bendable inner shaft portion 147 m m . Figure 32 The bendable inner shaft portion 147 in the exemplary embodiment shown m comprises a plurality of bellows that render the bendable inner shaft portion 147 m flexible.

[0459] Figure 33B shows an embodiment of the bendable inner shaft portion 147 m wherein the bendable inner shaft portion 147 m is bent relative to the outer shaft 120 i such that the front plane 54 of the grasping element, which is now at an angle β relative to the centerline 50 of the outer shaft 120 i , is substantially aligned with the adjacent plane of the pericardium 14, such that the grasping element 190 contacts the pericardium substantially along the entire periphery of the distal surface 196 of the grasping element.

[0460] According to some embodiments, the bendable inner shaft portion 147 is configured to transition between an unbent shaft state when no external force acts on the bendable inner shaft portion 147 and a bent shaft state when an external force is applied, such as when the grasping element 190 bears against the distal surface.

[0461] Although Figures 33A to 33B the grasping element 190 shown in the exemplary embodiment of m is attached to the inner shaft 140 i and is disposed within the outer shaft 120 connected to the vertebral head, it will be apparent that any inner shaft 140 having a bendable inner shaft portion 147, any outer shaft 120, and any vertebral head 160 disclosed throughout the specification can be combined.

[0462] Now refer to Figures 34A to 34D . Figures 34A to 34C A cross-sectional side view showing different states of the distal portion of a non-penetrating tissue separator 100 equipped with a spring-coiled vertebral head 160 m in accordance with some embodiments. Figure 34D Showing a non-penetrating tissue separator equipped with a spring vertebral head 160 m ​The distal portion of the non-penetrating tissue separator 100 is in Figure 34C a perspective view of a second state.

[0463] According to some embodiments, the non-penetrating tissue separator 100 of any of the embodiments disclosed throughout the specification includes a spring-coiled vertebral head 160 m , the spring-coiled vertebral head 160 m formed as at least one helical coil having a plurality of spaced-apart turns. The vertebral proximal portion 140 m is attached to the distal lip 126 of the outer shaft. According to some embodiments, the diameter of the lowermost turn of the spring-coiled vertebral head 160 m is substantially equal to the diameter of the distal lip 126 of the outer shaft.

[0464] The spring-coiled vertebral head 160 that may define a vertebral opening 168 m has an outer diameter of the lowermost turn that is larger than the diameter of the distal lip 126 of the outer shaft. According to some embodiments, each adjacent turn from the proximal end to the distal end of the spring-coiled vertebral head 160 m has an increasing diameter in the free spring state, which is defined as the state in which the spring-coiled vertebral head 160 m is not subject to any external force. m

[0465] According to some embodiments, the non-penetrating tissue separator 100 further includes a delivery shaft 121 that is coaxial with at least a portion of the outer shaft 120 and disposed around the at least a portion of the outer shaft 120 to enable relative axial movement between the outer shaft 120 and the delivery shaft 121. Specifically, at least one of the outer shaft 120 or the delivery shaft 121 can move axially relative to the delivery shaft 121 or the outer shaft 120, respectively, for example, axially move in a telescoping manner.

[0466] According to some embodiments, the outer shaft 120 can move distally while the delivery shaft 121 is stationary, thereby causing the spring-coiled vertebral head 160 attached to the distal end of the outer shaft 120 m to move distally relative to the distal lip 123 of the delivery shaft. According to some embodiments, the delivery shaft 121 can move proximally while the outer shaft 120 is stationary, thereby causing the distal lip 123 of the delivery shaft to move proximally relative to the distal portion 166 of the vertebral body m .

[0467] According to some embodiments, the outer shaft 120 can slide freely within the lumen of the delivery shaft 121. According to some embodiments, the delivery shaft 121 can slide freely on the outer shaft 120.

[0468] According to some embodiments, the spring coiled vertebral head 160 m can be fully retained within the lumen of the delivery shaft 121. According to some embodiments, the vertebral opening 168 m has a diameter greater than the diameter of the distal lip 123 of the delivery shaft.

[0469] Figure 34A shows the spring coiled vertebral head 160 m retained within the delivery shaft 121 along its entire length such that the distal portion 166 of the vertebra m is flush with or near the distal lip 123 of the delivery shaft.

[0470] According to some embodiments, at least some of the coils of the spring coiled vertebral head 160 m , mainly the distal coils, can have their diameter reduced with a suitable readjustment of the space between these adjacent coils in order to accommodate the spring coiled vertebral head 160 m within the delivery shaft 121.

[0471] Figure 34B shows the spring coiled vertebral head 160 m fully extending beyond the distal lip 123 of the delivery shaft, thereby allowing the coils of the spring coiled vertebral head 160 m to expand to its spring free state. This can be achieved by retracting the delivery shaft 121 relative to the outer shaft 120 in the proximal direction 94 or by advancing the outer shaft 120 relative to the delivery shaft 121 in the distal direction 92.

[0472] According to some embodiments, only a portion of the spring coiled vertebral head 160 m extends beyond the distal lip 123 of the delivery shaft, the length of this portion being sufficient for all the coils of the spring coiled vertebral head 160 m to expand to the spring free state such that no coil that remains surrounded by the delivery shaft 121 contacts the inner wall of the delivery shaft 121 or is squeezed by the inner wall of the delivery shaft 121.

[0473] When the spring coiled vertebral head 160 m extends fully or partially beyond the distal lip 123 of the delivery shaft, the distal edge defined by the farthest distal coil of the spring coiled vertebral head 160 m serves as the distal end of the non-penetrating tissue separator 100.

[0474] Figure 34B The grasping element 190 in is shown in a first state, close to the distal end of the non-penetrating tissue separator 100, or in other words, close to the distal edge of the spring coiled vertebral head 160 m .

[0475] Figures 34C to 34D shows the grasping element 190 in a second state, which is distal to the distal end of the non-penetrating tissue dissector 100, in other words, distal to the distal edge of the spring coiled vertebral head 160 m . This can be achieved, for example, by advancing the outer shaft 140 together with the grasping element 190 in the distal direction 92

[0476] According to some embodiments, the spring coiled vertebral head 160 m includes a single helical coil as Figures 34A to 34D shown. According to some embodiments, the spring coiled vertebral head 160 includes two concentric helical coils (not shown in the embodiment). According to some embodiments, the two coils of the spring coiled vertebral head 160 are wound in the same direction

[0477] According to some embodiments, a non-penetrating tissue dissector 100 is provided, which includes a delivery shaft 121 and a vertebral head 160o, and the vertebral head 160o includes a plurality of wings 170 0 , and the plurality of wings 170 0 are oriented in the distal axial direction and are separated by notches between the wings 170 (not shown in the embodiment). Each wing 170 0 includes a wing distal lip 172o, and the plurality of wing distal lips 172 0 together form a vertebral distal lip 174 0 0 .

[0478] Different from the wings 170 Figures 1C to 1E having internal flexibility such that the wings 170 are spring biased radially inwardly, the wings 170 0 have internal flexibility such that the wings 170 0 are spring biased radially outwardly and can be pushed radially inward by a force applied to the wings 170 0 . When no external force is applied to the wings 170 0 , the distal lips 172o of the wings 170 0 expand radially away from each other to form a wider vertebral opening 168 relative to the unexpanded (or contracted) posture 0 .

[0479] According to some embodiments, the vertebral head 160o is configured to switch between an unexpanded (or contracted) state when the wings 170 of the vertebral head 160o 0 are held within the lumen of the delivery shaft 121 and an expanded state when the wings 170 0 extend distally to the distal lip 123 of the delivery shaft ​

[0480] According to some embodiments, the outer shaft 120 may move distally while the delivery shaft 121 is stationary, thereby causing the vertebral head 160o attached to the distal end of the outer shaft 120 to move distally relative to the distal lip 123 of the delivery shaft, so that the wings 170 of the vertebral head 160o 0 radially expand outwardly to its expanded state. According to some embodiments, the delivery shaft 121 may move proximally while the outer shaft 120 is stationary, thereby causing the distal lip 123 of the delivery shaft to move proximally relative to the distal portion 166 of the vertebra 0 while the wings 170 0 expand to its expanded state.

[0481] According to some embodiments, the vertebral head 160 0 may be fully retained within the lumen of the delivery shaft 121. According to some embodiments, when the wings 170 0 are expanded, the diameter of the vertebral opening 168 0 is greater than the diameter of the distal lip 123 of the delivery shaft.

[0482] According to some embodiments, the vertebral head 160 0 is designed such that a portion of the vertebral head 160 0 is sufficient to extend beyond the distal lip 123 of the delivery shaft to fully expand the wings 170 0 to its fully expanded state.

[0483] When the vertebral head 160 0 extends fully or partially beyond the distal lip 123 of the delivery shaft, the distal vertebral lip 174o of the vertebral head 160 0 serves as the distal end of the non-penetrating tissue separator 100.

[0484] According to some embodiments, the outer shaft 120 may retract proximally while the delivery shaft 121 is stationary, thereby causing the wings 170 0 to radially contract within the lumen of the delivery shaft 121. According to some embodiments, the delivery shaft 121 may move proximally while the outer shaft 120 is stationary, thereby causing the wings 170 0 to radially contract within the lumen of the delivery shaft 121.

[0485] According to some embodiments, a non-penetrating tissue separator 100 is provided that includes a vertebral head 160o (not shown in the embodiment) attached to the inner shaft 140 rather than to the outer shaft 120. In such an embodiment, the vertebral head 160o is configured to be in an unexpanded (or contracted) state when the wings 170 of the vertebral head 160o 0 are retained within the lumen of the outer shaft lumen 132 and the wings 170 0Switch between the expanded state when the distal lip 126 of the outer shaft extends distally.

[0486] According to some embodiments, the inner shaft 140 can move distally while the outer shaft 120 is stationary, thereby causing the vertebral head 160o attached to the distal portion 144 of the inner shaft to move distally relative to the distal lip 126 of the outer shaft, so that the wings 170 of the vertebral head 160o 0 Radially expand outward to its expanded state. According to some embodiments, the outer shaft 120 can move proximally while the inner shaft 140 is stationary, thereby causing the distal lip 126 of the outer shaft to move proximally relative to the distal portion 166 of the vertebra 0 Move proximally while the wings 170 0 Expand to its expanded state.

[0487] According to some embodiments, the vertebral head 160 0 Can be fully retained within the lumen 132 of the outer shaft. According to some embodiments, when the wings 170 0 Expand, the diameter of the vertebral opening 168 0 Is greater than the diameter of the distal lip 126 of the outer shaft.

[0488] According to some embodiments, the vertebral head 160 0 Is designed such that a portion of the vertebral head 160 0 Is sufficient to extend beyond the distal lip 126 of the outer shaft so that the wings 170 0 Fully expand.

[0489] When the vertebral head 160 0 Fully or partially extends beyond the distal lip 126 of the outer shaft, the distal lip 174o of the vertebral head 160 0 Serves as the distal end of the non-penetrating tissue separator 100.

[0490] According to some embodiments, the inner shaft 140 can retract proximally while the outer shaft 120 is stationary, thereby causing the wings 170 0 To radially contract inwardly within the lumen 132 of the outer shaft. According to some embodiments, the outer shaft 120 can move proximally while the inner shaft 140 is stationary, thereby causing the wings 170 0 To radially contract inwardly within the lumen 132 of the outer shaft.

[0491] Advantageously, the expandable vertebral head 160 (such as, but not limited to, the vertebral head 160 n 、160 0The embodiment) can advance the distal end of the non-penetrating tissue separator 100 through the patient's organs or tissues in the unexpanded or contracted state of the vertebral head 160 until near the chest cavity or near the heart 10, thereby reducing the front surface area in contact with these tissues and reducing the resistance to advancing the device 100. At the same time, the vertebral head 160 can expand only when reaching near the heart 10, such as near the pericardial tissue 14, to present its conical profile.

[0492] According to some embodiments, some of the components of the non-penetrating tissue separator 100 are reusable, and some of the components of the non-penetrating tissue separator 100 are disposable. According to some embodiments, the handle 102 is reusable. According to some embodiments, at least one of the inner shaft 140, the outer shaft 120, the grasping element 190, and the vertebral head 160 is disposable and can be replaced for each surgery.

[0493] According to some embodiments, some of the components of the non-penetrating tissue separator 100 are replaceable. According to some embodiments, the shaft springs 116, 116 a a, 116 a b are replaceable. The spring constant k of the shaft springs 116, 116 a a, 116 a b can be selected to have a sufficient required expansion / contraction range and avoid high stiffness that may cause the non-penetrating tissue separator 100 to exert high pressure on the heart 10 during the surgery.

[0494] According to some embodiments, different shaft springs 116, 116 a a, 116 a b can be configured to be used with patients presenting different characteristics, anatomies, or pathologies, such that appropriate shaft springs 116, 116 a a, 116 a b can be installed in the non-penetrating tissue separator 100 according to the characteristics of the patient.

[0495] According to some embodiments, the grasping element 190 is replaceable. According to some embodiments, different grasping elements 190 can be configured to be used with patients presenting different characteristics, anatomies, or pathologies, such that appropriate grasping elements 190 can be installed in the non-penetrating tissue separator 100 according to the characteristics of the patient.

[0496] According to some embodiments, the vertebral head 160 is replaceable. According to some embodiments, different vertebral heads 160 may be configured to be used with patients presenting different characteristics, anatomies, or pathologies, such that an appropriate vertebral head 160 can be installed in the non-penetrating tissue separator 100 according to the characteristics of the patient.

[0497] According to some embodiments, the non-penetrating tissue separator 100 further includes a rotation limiting mechanism configured to limit the maximum rotation of the grasping element 190. According to some embodiments, the rotation limiting mechanism is configured to limit the rotation of the grasping element 190 within a predetermined range. According to some embodiments, the rotation limiting mechanism is configured to limit the rotation of the grasping element 190 within a range of 0 to 270 degrees. According to some embodiments, the rotation limiting mechanism is configured to limit the rotation of the grasping element 190 within a range of 0 to 180 degrees.

[0498] According to some embodiments, the rotation limiting mechanism is configured to limit the rotation of the grasping element 190 to a limited amount of rotation in at least one direction.

[0499] Advantageously, the rotation limiting mechanism can be designed to allow the maximum degree of rotation or alternatively the maximum amount of rotation that inhibits damage to the tissue being grasped, such as the pericardium 14, by the grasping element 190.

[0500] According to some embodiments, the grasping element 190 includes a ferromagnetic material, and the non-penetrating tissue separator 100 further includes a magnetic attraction component proximate to the grasping element 190, the magnetic attraction component being configured to apply a magnetic force to attract or repel the grasping element 190 (embodiments not shown).

[0501] According to some embodiments, the magnetic attraction component is attached to the inner shaft 140. According to some embodiments, the magnetic attraction component is attached to the outer shaft 120. According to some embodiments, the magnetic attraction component is disposed within the inner shaft lumen 152. According to some embodiments, the magnetic attraction component is disposed within the outer shaft lumen 132. According to some embodiments, the magnetic attraction component is disposed on the outer surface 128 of the outer shaft.

[0502] According to some embodiments, the magnetic attraction component can be axially manipulated, for example, via the handle 102 in the distal and proximal directions. According to some embodiments, the magnetic attraction component can be rotated, for example, via the handle 102 about the axis of symmetry of the magnetic attraction component.

[0503] According to some embodiments, the magnetic attraction member can be displaced between a non-attraction state in which the grasping element 190 is not attracted to the magnetic attraction member and an attraction state in which the grasping element 190 is attracted to the magnetic attraction member. According to some embodiments, an operator of the non-penetrating tissue separator 100 can control the position of the magnetic attraction member, such as the distance between the magnetic attraction member and the grasping element 190, to switch between the non-attraction state and the attraction state.

[0504] In use, the magnetic attraction member can switch to the non-attraction state or remain in the non-attraction state when the grasping element 190 moves from the first state to the second state, and the magnetic attraction member can switch to the attraction state after the pericardium 14 is sufficiently wrapped around the grasping element 190 to facilitate proximal retraction of the grasping element 190.

[0505] According to some embodiments, the inner shaft 140 includes inner shaft surface features that are disposed along at least a portion of the outer surface 148 of the inner shaft and extend proximally from the grasping element 190.

[0506] According to some embodiments, the inner shaft 140 includes inner shaft surface features that are disposed along at least a portion of the distal portion 144 of the inner shaft.

[0507] The inner shaft surface features can be in any form disclosed for the surface features 188 of the grasping element 190 and can be shaped similarly to or differently from the surface features 188 disposed along at least one surface of the grasping element 190.

[0508] Advantageously, when tissue is wrapped around the grasping element 190 and advanced proximally to further wrap around the distal portion 144 of the inner shaft, the inner shaft surface features support further wrapping and retention of the tissue.

[0509] According to some embodiments, the methods and devices of the present disclosure are used in at least one of the following therapeutic procedures: laparoscopic surgery, AV fistula access, bone biopsy, arthroscopic surgery, thoracentesis, thoracoscopic surgery, pleural puncture, amniocentesis, abscess drainage, hemodialysis, or peritoneal.

[0510] It should be understood that certain features of the invention described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, the various features of the invention described in the context of a single embodiment may also be provided separately or in any suitable sub-combination or in any other described embodiment of the invention. Any feature described in the context of an embodiment should not be considered an essential feature of that embodiment unless expressly so specified.

[0511] Although the present invention has been described in connection with specific embodiments thereof, it will be apparent that various alternatives, modifications, and variations will be apparent to those skilled in the art. It should be understood that the present invention is not necessarily limited in its application to the details of construction and arrangement of the components and / or methods set forth herein. Other embodiments may be implemented, and the embodiments may be implemented in various ways. Accordingly, the present invention encompasses all such alternatives, modifications, and variations that fall within the scope of the claims.

Claims

1. A non-penetrating tissue separator, comprising: An outer shaft having an outer shaft lumen, a distal portion of the outer shaft, and a distal lip of the outer shaft; An inner shaft having an inner shaft lumen and an outer surface of the inner shaft; A grasping element attached to a distal edge of the inner shaft and having a distal surface of the grasping element, a proximal surface of the grasping element, a circumferential surface of the grasping element, an inner opening of the grasping element, and surface features disposed along at least one of the distal surface of the grasping element, the proximal surface of the grasping element, or the circumferential surface of the grasping element; Wherein at least a portion of the outer shaft is disposed around at least a portion of the inner shaft to enable relative axial movement between the inner shaft and the outer shaft, thereby facilitating positioning of the grasping element between a first state and a second state; Wherein the grasping element is capable of rotating about a central axis of the grasping element; Wherein the central axis of the grasping element is oriented in a distally oriented direction, orthogonal to the distal surface of the grasping element; and Wherein the surface features are non-damaging surface features configured to releasably engage and grasp tissue via the surface features during rotational movement of the grasping element about the central axis of the grasping element without cutting, slicing, or penetrating the tissue, and to hold the tissue engaged therewith after the rotational movement stops and when the grasping element is pulled in the proximal direction.

2. The non-penetrating tissue separator according to claim 1, further comprising a handle attached to at least one of the inner shaft and the outer shaft, wherein, The handle is configured to facilitate relative axial movement between the inner shaft and the outer shaft, and wherein the handle is configured to facilitate rotation of the grasping element.

3. The non-penetrating tissue separator according to claim 2, wherein, The handle further includes a steering knob that engages the inner shaft and is configured to facilitate at least one of axial movement or rotational movement of the inner shaft.

4. The non-penetrating tissue separator according to claim 3, wherein, The steering knob is configured to rotate about a central axis of the steering knob, and wherein the inner shaft is threadedly engaged with the steering knob.

5. The non-penetrating tissue separator according to any one of claims 3 to 4, wherein, The handle further includes a first handle recess, and wherein the steering knob is disposed within the first handle recess.

6. The non-penetrating tissue separator according to claim 3, wherein, The steering knob includes an inner bore of the steering knob configured to receive the inner shaft extending therethrough such that the inner shaft is configured to axially move through the inner bore of the steering knob.

7. The non-penetrating tissue separator according to claim 6, wherein, The inner shaft is configured to act axially within the inner bore of the steering knob via a roller bearing attached to the inner shaft.

8. The non-penetrating tissue separator according to any one of claims 2 to 4, wherein, The handle further includes a second handle recess configured to visually expose at least a portion of the inner shaft extending therethrough.

9. The non-penetrating tissue separator according to claim 8, further comprising a first shaft spring disposed between the inner shaft and the handle, the first shaft spring being configured to provide resistance to proximal displacement of the inner shaft.

10. The non-penetrating tissue separator according to claim 9, further comprising a second shaft spring disposed between the inner shaft and the handle, the second shaft spring being configured to provide resistance to distal displacement of the inner shaft.

11. The non-penetrating tissue separator according to any one of claims 9 to 10, further comprising a marker for indicating at least one of the following: the position of the grasping element, the force exerted by the grasping element when pressed against the outer surface, whether the tissue provides resistance to proximal pulling of the grasping element, or whether the tissue has been grasped by the grasping element.

12. The non-penetrating tissue separator according to claim 11, wherein, The inner shaft includes structural features or markings that can be compared with the markings.

13. The non-penetrating tissue separator according to claim 8 further includes a lid configured to at least cover the second handle recess.

14. The non-penetrating tissue separator according to any one of claims 2 to 4 further includes a latching mechanism, the latching mechanism including: A lever pivotally movable about a pivot of a lever support body, the lever support body fixedly attached to the outer shaft; And A grooved element including at least two axially spaced grooves, wherein each groove is configured to receive an end portion of the lever, and wherein the grooved element is fixedly attached to the handle.

15. The non-penetrating tissue separator according to claim 14, wherein, The latch mechanism further includes a knob attached to an end of the lever and a knob spring disposed between the knob and the lever support body.

16. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, Relative axial movement between the inner shaft and the outer shaft is facilitated by a threaded engagement between the inner shaft and the outer shaft.

17. The non-penetrating tissue separator according to any one of claims 2 to 4, wherein, Relative axial movement between the inner shaft and the outer shaft is facilitated by a threaded engagement between the inner shaft and the handle.

18. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, The outer diameter of the grasping element is smaller than the diameter of the outer shaft lumen such that the grasping element is configured to be inserted into the outer shaft lumen.

19. The non-penetrating tissue separator according to any one of claims 1 to 4 further includes an inner shaft retraction limiting mechanism configured to limit the maximum retraction of the grasping element in the proximal direction.

20. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, The outer shaft lumen includes a distal tapered portion of the outer shaft that radially tapers inwardly in the proximal direction from the distal lip of the outer shaft.

21. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, The outer shaft lumen includes a distal slot of the outer shaft that extends between the distal lip of the outer shaft and the distal slot shoulder of the outer shaft.

22. The non-penetrating tissue separator according to any one of claims 1 to 4 further includes a vertebral head attached to the distal portion of the outer shaft and having a distal lip of the vertebral head defining an opening of the vertebral head.

23. The non-penetrating tissue separator according to claim 22, wherein, The vertebral head further includes a plurality of wings configured to switch between a non-expanded state and an expanded state.

24. The non-penetrating tissue separator according to claim 23, wherein, The wings are spring-biased radially inwardly and wherein the wings are configured to radially expand outwardly due to an internal thrust applied to the inner surface of the vertebral body during axial movement of the grasping element along the inner surface of the vertebral body.

25. The non-penetrating tissue separator according to claim 23, wherein, The vertebral head is threadedly engaged with the grasping element and wherein the plurality of wings are configured to radially expand outwardly to an expanded state when the grasping element is threadedly transferred from the first state to the second state.

26. The non-penetrating tissue separator according to claim 22, wherein, The vertebral head is formed as a rigid non-deformable structure.

27. The non-penetrating tissue separator according to claim 22, wherein, The vertebral head is formed as at least one helical coil having a plurality of spaced-apart turns.

28. The non-penetrating tissue separator according to any one of claims 1 to 4 further comprises a delivery shaft disposed around at least a portion of the outer shaft to enable relative axial movement between the outer shaft and the delivery shaft.

29. The non-penetrating tissue separator according to claim 22, wherein, The vertebral head is configured to tilt relative to the outer shaft so as to transition between a non-tilted vertebral state and a tilted vertebral state.

30. The non-penetrating tissue separator according to claim 29, wherein, The vertebral head is pivotally attached to the outer shaft.

31. The non-penetrating tissue separator according to claim 29, wherein, At least a portion of the vertebral head includes at least one of a flexible material or a shape memory material.

32. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, The grasping element is disc-shaped such that the axial length of the grasping element is shorter than the outer diameter of the grasping element.

33. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, The grasping element is elongate such that the axial length of the grasping element is equal to or longer than the outer diameter of the grasping element.

34. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, The inner shaft includes a bendable inner shaft portion and a rigid inner shaft portion such that the distal end of the inner shaft is configured to bend relative to the outer shaft.

35. The non-penetrating tissue separator according to claim 34, wherein, The bendable inner shaft portion includes a material that is more flexible than the material of the rigid inner shaft portion.

36. The non-penetrating tissue separator according to claim 34, wherein, The bendable inner shaft portion includes a spring.

37. The non-penetrating tissue separator according to claim 34, wherein, The bendable inner shaft portion includes slots or bellows that render the bendable inner shaft portion flexible.

38. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, The inner shaft further includes an inner shaft threaded portion that extends proximally from its connection interface with the grasping element.

39. The non-penetrating tissue separator according to any one of claims 1 to 4, wherein, The inner shaft further includes inner shaft surface features disposed along at least a portion of the outer surface of the inner shaft.

40. The non-penetrating tissue separator according to any one of claims 1 to 4 further comprises at least one ECG electrode.

41. A kit comprising the non-penetrating tissue separator according to any one of claims 1 to 40, and a passage device capable of passing through the inner shaft lumen and through the inner opening of the grasping element and configured to pierce, cut or penetrate the pericardium.

42. The kit according to claim 41, wherein, The access device is a needle that includes a distal needle portion.

43. The kit according to claim 41 further comprises a needle limiting element configured to limit the penetration depth of the needle.

44. The kit according to any one of claims 42 to 43, wherein,The distal needle portion is curved.

45. The kit according to claim 41, wherein, The access device includes a threaded portion having a circumferentially oriented sharp end configured to pierce or penetrate the pericardium from a lateral direction during rotation of the threaded portion.

46. The kit according to claim 41, further comprising a guide wire.

47. A kit comprising a non-penetrating tissue separator according to any one of claims 1 to 40 and a balloon catheter configured to inflate a balloon distal to the non-penetrating tissue separator.

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