Devices, systems, and methods for endoluminal puncture

Abstract

Disclosed are devices, systems, and methods for an intraluminal puncture system. A first catheter has a flexible positioning arm extending from its distal end and is configured for delivery within an anatomical vessel. The flexible positioning arm is configured to transition between a collapsed orientation and an extended orientation. A second catheter is disposed within the first catheter and has an open distal end secured to the positioning arm such that the open distal end faces the wall of the anatomical vessel when the flexible positioning arm is in the extended orientation. An elongate shaft can extend through the second catheter. A tissue piercer is located on the distal end of the elongate shaft. The tissue piercer is configured to advance axially within the second catheter and is operably connected to the open distal end of the second catheter.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is based on and claims the benefit of priority from U.S. Provisional Patent Application No. 63 / 384,517, filed November 21, 2022, the contents of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to endoluminal surgical tool delivery systems and methods, and more particularly to endoluminal systems and methods for delivery within a blood vessel to puncture a wall from within the blood vessel. [Background technology]

[0003] With advances in minimally invasive surgery, surgical tools are often delivered through a lumen to work within the lumen. However, piercing a lumen from the inside can present challenges. Such challenges can arise, for example, when the target puncture site is a blood vessel wall. Because the diameter of a blood vessel is relatively small, positioning a tool guide to guide a puncture tool at an acute angle relative to the blood vessel wall may seem like a reasonable option. However, when a blood vessel has a certain degree of curvature or contains fragile anatomical tissue on the opposite side of the blood vessel wall, an acute angle of delivery may be associated with risks. Furthermore, the limited working diameter inside the blood vessel can make it difficult to increase the angle of the tool guide positioned to deliver the puncture tool.

[0004] Furthermore, as the needle penetration angle from within the delivery device at the vessel wall increases, several additional risks emerge, including axial displacement of the delivery device. Therefore, there is a need for an intraluminal puncture system capable of controlled, nearly perpendicular puncture relative to the longitudinal axis of the delivery system. The devices, systems, and methods described herein address at least some of the shortcomings of conventional surgical tools. Such devices, systems, and methods may reduce the risk of erroneous or unintentional puncture, particularly in curved vessels, using, for example, the ability to control the angle of the tool guide at the target vessel. While the devices, systems, and methods described herein may be used for orthogonal or near-orthogonal intraluminal wall puncture, it should be understood that the inventive concepts described herein are not so limited. Depending on the particular application, the principles of the present disclosure may be applied to orthogonal and non-orthogonal punctures without departing from the scope and spirit of the present disclosure. Summary of the Invention [Problem to be solved by the invention]

[0005] Embodiments consistent with the present disclosure provide devices, systems, and methods for endoluminal puncture. [Means for solving the problem]

[0006] Some embodiments include an intraluminal puncture system. Such a system may include a first catheter having a flexible positioning arm extending from a distal end and configured for delivery within an anatomical vessel. The flexible positioning arm may be configured to transition between a collapsed orientation and an extended orientation. Some embodiments may also include a second catheter disposed within the first catheter. The second catheter may have an open distal end secured to the positioning arm such that the second catheter faces a wall of the anatomical vessel when the flexible positioning arm is in the extended orientation. Some embodiments may further include an elongate shaft extending through the second catheter and / or a tissue piercer located at the distal end of the elongate shaft. The tissue piercer may be configured for axial advancement within the second catheter and operably connected to the open distal end of the second catheter.

[0007] Some embodiments include a method for puncturing the wall of an anatomical vessel. Such a method may include advancing a flexible catheter having an open distal end within the anatomical vessel and manipulating the open distal end so that the open distal end faces a target location on the wall of the anatomical vessel. Bracing the open distal end within the vessel may be provided to limit movement of the open distal end. A tissue piercer may be advanced through the flexible catheter to puncture the wall of the anatomical vessel at the target location.

[0008] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate various disclosed embodiments and, together with the description, serve to explain the disclosed embodiments. The details shown are merely examples for purposes of illustrating exemplary embodiments of the present disclosure. The description, taken together with the drawings, will make apparent to those skilled in the art how embodiments of the present disclosure may be practiced. [Brief explanation of the drawings]

[0009] [Figure 1]1 is a side view of a portion of an exemplary endoluminal puncture system within a blood vessel consistent with certain embodiments of the present disclosure.

[0010] [Figure 2A] 10A-10C are side views of various configurations of flexible positioning arms consistent with certain embodiments of the present disclosure. [Figure 2B] 10A-10C are another side view of various configurations of flexible positioning arms consistent with certain embodiments of the present disclosure.

[0011] [Figure 3] FIG. 1 is a cross-sectional side view of the internal structure of an exemplary second catheter, consistent with certain embodiments of the present disclosure.

[0012] [Figure 4] FIG. 1 is a perspective view of a distal end of an exemplary endoluminal puncture system having multiple flexible support arms, consistent with certain embodiments of the present disclosure.

[0013] [Figure 5] FIG. 1 is a side perspective view of an example of a distal end of an endoluminal puncture system with a blade-shaped tissue piercer for piercing a vessel wall, consistent with some embodiments of the present disclosure.

[0014] [Figure 6] FIG. 1 is a side perspective view of a portion of an endoluminal puncture system having controls for radial and axial manipulation of each of an elongate shaft, a first catheter, and a second catheter, consistent with some embodiments of the present disclosure.

[0015] [Figure 7] FIG. 10 is a side perspective view of an exemplary hollow tube within a second catheter configured to act as a placeholder during replacement of a puncture device with a guidewire, consistent with certain embodiments of the present disclosure.

[0016] [Figure 8A]FIG. 1 is a side perspective view of a portion of an endoluminal puncture system prior to tissue puncture, consistent with some embodiments of the present disclosure. [Figure 8B] FIG. 10 is another side perspective view of a portion of the endoluminal puncture system after tissue puncture, consistent with some embodiments of the present disclosure.

[0017] [Figure 9] 1 is a flowchart of an exemplary process for puncturing a wall of an anatomical vessel, consistent with certain embodiments of the present disclosure.

[0018] [Figure 10A] 1 is a side perspective view of a portion of an endoluminal puncture system at a stage of deployment during a method for puncturing a wall of an anatomical vessel, consistent with some embodiments of the present disclosure. FIG. [Figure 10B] FIG. 10 is another side perspective view of a portion of an endoluminal puncture system at a next stage of deployment during a method for puncturing a wall of an anatomical vessel, consistent with some embodiments of the present disclosure. [Figure 10C] FIG. 10 is another side perspective view of a portion of an endoluminal puncture system at a next stage of deployment during a method for puncturing a wall of an anatomical vessel, consistent with some embodiments of the present disclosure. [Figure 10D] FIG. 10 is another side perspective view of a portion of an endoluminal puncture system at a next stage of deployment during a method for puncturing a wall of an anatomical vessel, consistent with some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] Exemplary embodiments are described with reference to the accompanying drawings. The drawings are not necessarily drawn to scale. While examples and features of the disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Additionally, the words "comprising," "having," "containing," "including," and other similar forms are intended to be equivalent in meaning and open-ended in that the one or more items following any one of these words are not intended to be an exhaustive listing of such one or more items or to be limited to only the listed one or more items. It should also be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Furthermore, relational terms such as "first" and "second" herein are used only to distinguish one entity or operation from another and do not require or imply an actual relationship or order between those entities or operations.

[0020] As used herein, unless expressly stated otherwise, the term "or" includes all possible combinations unless impracticable. For example, if it is stated that a component can include A or B, the component can include A or B, or A and B, unless expressly stated otherwise or impracticable. As a second example, if it is stated that a component can include at least one of A, B, or C, the component can include A, B, or C, or A and B, or A and C, or B and C, or A, B, and C, unless expressly stated otherwise or impracticable.

[0021] This disclosure uses open-ended permissive language, such as indicating that some embodiments "may" use, "may" be accompanied by, or "may include" a particular feature. Use of the term "may" and other open-ended terms is intended to indicate that not all embodiments necessarily use a particular disclosed feature, but that at least one embodiment does use a particular disclosed feature.

[0022] In the following description, various examples are provided for illustrative purposes. However, it should be understood that the present disclosure may be practiced without one or more of these details. Reference will now be made in detail to non-limiting examples of the present disclosure, examples of which are illustrated in the accompanying drawings. The examples are described below by reference to the drawings, in which like reference numbers refer to like elements. Where like reference numbers are shown, corresponding descriptions will not be repeated and the interested reader is referred to previously discussed figures for descriptions of like elements.

[0023] Some disclosed embodiments include an endoluminal puncture system. An endoluminal puncture system refers to any device or structure configured to puncture, pierce, enter, or otherwise access the interior of a tubular structure within a body, such as a blood vessel, the digestive tract, or other hollow organ. Examples of endoluminal puncture systems include a needle configured for insertion into a vein, a catheter configured to puncture an artery, or a blade configured to cut into tissue of a hollow organ. For example, FIG. 1 illustrates an exemplary endoluminal puncture system 100 consistent with some embodiments of the present disclosure. The system 100 may include a first catheter 102 having multiple arms, including a flexible support arm 116 and a flexible positioning arm 112. The flexible positioning arm 112 may include a puncture positioning structure 113 defining an orifice 114 at a distal end configured to position a tissue puncture device 118 against a target surface, such as the wall of an anatomical vessel. The second catheter 104 may be configured to control the transition between the two operable orientations of the system (i.e., the collapsed orientation and the extended orientation) via axial movement. The system 100 may include a second catheter 104 having a flexible distal end configured to shift the puncture positioning structure 113 (i.e., the periphery defining the orifice 114) from a collapsed orientation perpendicular to the longitudinal axis of the first catheter 102 to an angle away from that perpendicular axis, such as an extended orientation, to position the tissue piercer 118 relative to the target surface. The puncture positioning structure 113 may include a flat surface for purposes of defining the above-mentioned perpendicular and angle away from perpendicular. System 100 may include a second catheter 104 configured to shift the center of orifice 114 or puncture positioning structure 113 from a collapsed orientation in which the center of orifice 114 is generally aligned with the longitudinal axis of first catheter 102 to an expanded orientation in which the central axis of orifice 114 is offset relative to the longitudinal axis of first catheter 102. System 100 may also include a sheath 106 configured to collapse and expand arms 116 and 112 during deployment.The system 100 may also include a proximal end 108 of the first catheter 102 for radial and axial control of the distal end of the first catheter 102. The system may further include a proximal end 111 of the second catheter 104 for controlling radial movement of the open distal end 126. The system may additionally or alternatively include a proximal end 108 of the first catheter 102 for controlling radial movement of the distal end of the first catheter 102. The sheath 106 and the proximal ends 108 and 111 may be individually controlled by a controller 110.

[0024] Some disclosed embodiments include a first catheter configured for delivery within an anatomical vessel, the first catheter having a flexible positioning arm extending from its distal end, the flexible positioning arm configured to transition between a collapsed and an expanded orientation. A catheter refers to any elongated, hollow, or tubular medical device configured to access or traverse a body cavity, duct, or vessel. Examples of catheters include straight-tip catheters, curved-tip catheters, J-tip catheters, radiopaque-tip catheters, split-tip catheters, balloon-tip catheters, microcatheters, guide catheters, and catheters with side holes. For example, the first catheter may include a tube with a straight, open-ended tip, such as a straight-tip catheter. For example, in FIG. 1 , the endoluminal puncture system 100 includes a tubular first catheter 102 with an open end. A flexible positioning arm refers to any branch, protrusion, extension, or structure configured to bend, twist, or move. Examples of flexible positioning arms include bendable, malleable, flexible, or otherwise yielding rods, wings, stents, or articulating sections. For example, in FIG. 1 , the first catheter 102 has a flexible positioning arm 112. In this example, the flexible positioning arm 112 is shown as a thin, malleable extension configured to bend toward and away from the first catheter 102. The flexible positioning arm may be made of any suitable biocompatible material. Non-limiting examples include nitinol, shape memory polymers, stainless steel, titanium and titanium alloys, polymer-based materials, and composite materials. Extending from the distal end refers to originating or extending outward from the farthest, outermost, or peripheral side, region, or edge of the first catheter. Examples of extending from the distal end include a structure emanating from, originating at, reaching out from, or attached to the distal end. For example, in FIG. 1, the flexible positioning arm 112 extends from the distal end 120 of the first catheter 102 by emanating from the distal end 120 in a direction away from the first catheter 102 .While the illustrative example shows emanating from the farthest distal edge, this is merely one example. Because the distal end may be a region, one or more arms may emanate from a location other than the farthest edge (i.e., extending from the end region), or may be part of a non-arm structure connected to the distal end and still be considered to extend from the distal end. A first catheter configured for delivery within an anatomical vessel refers to the first catheter being shaped or specifically manufactured to be introduced or placed within an anatomical vessel, such as a blood vessel, artery, vein, or other tubular structure within the human body, or to smoothly axially translate within another tubular or hollow structure, such as a sheath. This may include being constructed of a biocompatible material, such as PVC, silicone, latex, polyurethane, Teflon, nylon, or any other material or substance capable of performing its desired function within the body without eliciting an immune response, rejection, or adverse reaction. Other examples of the first catheter being configured for delivery within an anatomical vessel include the first catheter having a diameter small enough to enter the vessel, the first catheter being configured to compress to the diameter of the vessel, or the first catheter being shaped to move along the curvature of the vessel. In some examples, the first catheter may be configured for delivery within an anatomical vessel having a diameter of less than 10 mm, 8 mm, 6 mm, or 4 mm. For example, in FIG. 1 , the first catheter 102 may have a diameter smaller than 10 mm to enter a 10 mm diameter vessel. In some embodiments, the anatomical vessel may be a blood vessel. In some embodiments, the anatomical vessel may be a lumen within the human body. In some embodiments, the system is configured for delivery within an anatomical vessel having a diameter between 3 mm and 6 mm. A collapsed orientation refers to the state or position of a structure when its maximum distance, width, or span from a central axis is compressed, folded, reduced, or retracted to a smaller or more compact form. Examples of folded orientations include reducing the maximum distance, width, or span from the central axis of the structure, moving components of the structure closer together, and folding the structure inward.For example, FIGS. 2A and 2B illustrate various configurations of flexible positioning arms consistent with embodiments of the present disclosure. In some examples, in the collapsed orientation, the maximum diameter of the first catheter can be established when the flexible positioning arm is fully collapsed or compressed inward. This can occur, for example, when the arm is positioned within a catheter or sheath. For example, as shown in FIG. 2A, a sheath 204 maintains the arm 200 in a compressed state. When the arm 200 (made of a shape-memory material in this example) exits the sheath, the arm recovers to its predesigned shape. In such examples, the maximum radius of the first catheter from the central radius of the first catheter may be less than 5 mm, 4 mm, 3 mm, or 2 mm. As shown in the example of FIG. 2A, the flexible positioning arm 200 is in the collapsed orientation when folded inward or compressed such that the maximum distance, width, or span from the central axis of the flexible positioning arm 200 is minimized. The expanded orientation refers to the state or position of the structure when fully deployed, stretched, or extended to a greater maximum distance, width, or span from the central axis. For shape-memory materials, the expanded orientation may refer to achieving shape memory recovery. Examples of the expanded orientation include a structure that has been pulled, opened, or bent to a greater maximum distance, width, or span from the central axis. In some examples, the expanded orientation may establish the maximum diameter of the first catheter when the flexible positioning arms are fully extended outward. In such examples, the maximum radius of the first catheter from the central radius of the first catheter may be less than 10 mm, 9 mm, 7 mm, 6 mm, 5 mm, 4 mm, or 3 mm. For example, in FIG. 2B, the flexible positioning arm 200 is in the expanded orientation when it reaches its outermost position (i.e., the positioning arm 200 achieves maximum extension). The flexible positioning arm being configured to transition between a folded orientation and an extended orientation refers to the ability of the flexible positioning arm to change from a compact, compressed, or minimized state or position to a fully deployed, extended, or stretched state or position.Examples of flexible positioning arms configured to transition between the collapsed and expanded orientations include the flexible positioning arm being unfoldable, twistable, bendable, or otherwise subject to a change in configuration. The flexible positioning arm may transition between the collapsed and expanded orientations on its own or with an external input, such as mechanical and / or electrical control. For example, instead of a shape memory material mechanism for effecting expansion, in alternative embodiments, an electronic actuator may cause expansion, or a balloon may be inflated to cause expansion. With any such mechanism, an arm, such as flexible positioning arm 200, may be moved from a collapsed orientation, as shown in FIG. 2A, to an expanded orientation, as shown in FIG. 2B, by unfolding outward.

[0025] Consistent with some disclosed embodiments, the sheath, into which the first catheter is disposed and configured to move axially relative to the first catheter, is configured to hold the flexible positioning arms in a folded orientation and to allow the flexible positioning arms to transition to an extended orientation when the flexible positioning arms exit the sheath. The sheath into which the first catheter is disposed refers to a covering or encasement configured to surround or shield the first catheter. Examples of sheaths include an arterial sheath, a central venous sheath, a urinary catheter sheath, a pediatric catheter sheath, a neurovascular sheath, a gastrointestinal sheath, a vascular closure sheath, a peripherally inserted central catheter sheath, a dialysis sheath, a venous thrombectomy sheath, a thoracic sheath, or any other tubular structure for insertion into a blood vessel or body cavity. For example, FIG. 1 illustrates an example of a sheath 106 into which the first catheter 102 is disposed. In this example, the sheath 106 may be a central venous sheath used to access an anatomical vessel 122, which may be a vein. A sheath configured to move axially relative to the first catheter refers to the sheath being shaped or positioned to be inserted and moved relative to the first catheter. Examples of a sheath configured to move axially relative to the first catheter include a sheath that is movable proximally and distally outside the first catheter and a sheath configured to follow the curvature of the first catheter. When a sheath is part of a device configured to be used for relative axial movement, the sheath is positioned and configured for relative axial movement. For example, in FIG. 1 , sheath 106 is positioned on first catheter 102 and configured to move the first catheter up and down. A sheath configured to hold flexible positioning arms in a folded orientation refers to the sheath being positioned or shaped to maintain, support, hold, or preserve the flexible positioning arms in a folded orientation.Examples of sheaths configured to hold flexible positioning arms in a folded orientation include sheaths that include the flexible positioning arms, limit the movement of the flexible positioning arms, or fold the flexible positioning arms inward. For example, FIG. 2A shows a sheath 204 configured to move in a direction 206 away from the flexible positioning arms 200. In this example, the sheath 204 may hold the flexible positioning arms 200 in a folded orientation by keeping the flexible positioning arms 200 compressed within the diameter of the sheath 204 when the flexible positioning arms 200 are positioned within the sheath 204. A sheath configured to allow the flexible positioning arms to transition to an extended orientation when they exit the sheath refers to the ability to achieve relative movement between the sheath and the flexible positioning arms (e.g., by either allowing ejection of the positioning arms from the sheath or by a configuration that allows retraction of the sheath from the positioning arms) to allow the positioning arms to transition to an extended orientation without constraint by the sheath. 2B , as the sheath 204 slides away from the flexible positioning arm 200, the expansion of the flexible positioning arm 200 is no longer restricted. In this example, the unrestricted expansion of the flexible positioning arm 200 transitions the flexible positioning arm 200 to an unfolded, uncompressed, or extended orientation. In some embodiments, the sheath 204 is configured to hold the flexible positioning arm and the at least one flexible support arm in a folded orientation and to allow the flexible positioning arm and the at least one flexible support arm to move to their respective extended orientations when the flexible positioning arm and the at least one flexible support arm 200 exit or are pushed out of the sheath 204 or when the sheath 204 is retracted from the housing of the flexible positioning arm and the at least one flexible support arm.Some embodiments may include a sheath within which the first catheter is positioned, the sheath configured to move axially relative to the first catheter to hold the flexible positioning arm and the at least one flexible support arm in a collapsed orientation and to allow the flexible positioning arm and the at least one flexible support arm to move to their respective expanded orientations as they exit the sheath.

[0026] Consistent with some disclosed embodiments, the endoluminal puncture system may be configured to pierce one or more obstructions during delivery. For example, the endoluminal puncture system may include a serrated surface, a sharpened edge, or a rigid boundary for piercing or removing one or more obstructions. Examples of obstructions include plaque, thrombus, or foreign material in the sheath along a pathway, such as within an anatomical vessel.

[0027] Some disclosed embodiments include a second catheter disposed within a first catheter, the second catheter having an open distal end secured to the flexible positioning arm such that the second catheter faces the wall of the anatomical vessel when the flexible positioning arm is in an extended orientation. A second catheter refers to a catheter other than the first catheter, as previously described and illustrated. For example, in FIG. 1 , the endoluminal puncture system 100 includes a tubular, bendable second catheter 104. In some embodiments, the second catheter 104 is bendable at its distal end. As used herein, a second catheter having a bendable distal end may be referred to as a flexible catheter. Bendability may refer to the ability to form a bend radius of less than 6 mm or less than 4 mm. The bendable feature may be provided by forming the layers of the second catheter from a series of interconnected laser cutting units, or alternatively, by forming the second catheter from a flexible material. Disposing a second catheter within a first catheter refers to the second catheter being placed, inserted, or otherwise positioned within the first catheter. Examples of a second catheter being disposed within a first catheter include a second catheter being mounted within the first catheter, a second catheter being slidable within the first catheter, and / or a second catheter being disposed within the first catheter. For example, in FIG. 1 , the second catheter 104 is disposed within the first catheter 102, and therefore the second catheter 104 is disposed within the first catheter 102. A second catheter having an open distal end refers to the most distal or terminal portion of the second catheter being uncovered, exposed, or accessible. Examples of a second catheter having an open distal end include the distal end having a hole, multiple openings, or cavity therein. For example, in FIG. 1 , the second catheter 104 includes a distal end 126 that is an open distal end that allows for the entry of the tissue piercer 118. In some embodiments, the open distal end of the second catheter is configured to bend radially and axially.The open distal end being secured to the positioning arm refers to the open distal end being attached or fixed to the positioning arm. Examples of the open distal end being secured to the positioning arm include the open distal end and the positioning arm being connected by adhesive, welding, or a mechanical connection, or the open distal end and the positioning arm being interconnected components of a single structure. Exemplary securing structures include a threaded connector, a snap-fit ​​connector, a bayonet connector, a sleeve (mechanically joined by friction or adhesive or other bonding), a ferrule, or any other structure or mechanism that can be used to facilitate connection. For example, in FIG. 1 , the open distal end 126 is connected to the flexible positioning arm 112 by attaching the flexible positioning arm 112 to an orifice 114 disposed around the open distal end 126. The open distal end facing the wall of the anatomical vessel when the flexible positioning arm is in the expanded orientation refers to the open distal end being in direct contact with, engagement with, or proximity to the outer boundary or surface of the anatomical vessel when the flexible positioning arm is in the expanded orientation. Examples of the open distal end facing the wall of the anatomical vessel include the open distal end fully or partially touching the wall or being within a certain distance of the wall when the flexible positioning arms are in the extended orientation. For example, FIG. 1 shows an anatomical vessel 122, such as a vessel having a wall 124. In this example, when the flexible positioning arms 112 are extended outward, the open distal end 126 presses against the wall 124. The open distal end 126 contacts the wall 124 in the extended orientation because as the flexible positioning arms 112 extend toward the wall 124, they also pull the connected open distal end 126 toward the wall 124.

[0028] Consistent with some disclosed embodiments, at least one flexible support arm is movable from a collapsed orientation to an expanded orientation to cooperate with the flexible positioning arm to secure the distal end opening of the second catheter against the wall of the blood vessel. A flexible support arm refers to any component shaped or arranged to flexibly or adjustably support, hold, or position a structure. Examples of flexible support arms include bendable, malleable, flexible, or otherwise yielding rods, wings, stents, tabs, leaves, flaps, articulations, or any other appendages. For example, FIG. 1 shows the flexible support arm 116 shaped as a thin, malleable extension configured to bend toward and away from the first catheter 102. In some embodiments, at least one flexible support arm and flexible positioning arm include markers for radial and axial positioning of the system, the first catheter, or the second catheter. In some embodiments, at least one flexible support arm and flexible positioning arm include orientation markers. In some embodiments, at least one flexible support arm and the flexible positioning arm have a common length. In some embodiments, at least one flexible support arm and the flexible positioning arm have different lengths. In some embodiments, the flexible positioning arm is substantially less flexible than the at least one flexible support arm. The collapsed and extended orientations may be understood as previously described and illustrated. For example, in FIG. 2A , the flexible support arm 202 is in the collapsed orientation when compressed inward, minimizing the maximum distance, width, or span from the central axis of the flexible support arm 202. This minimum amount allows for smooth axial movement within the vessel. As another example, in FIG. 2B , the flexible support arm 200 is in the expanded orientation when expanded outward, minimizing the maximum distance, width, or span of an axis perpendicular to the central axis of the flexible support arm 200. This increase is typically sufficient to allow bracing or engagement of the vessel wall in the expanded orientation of the flexible support arm 200.At least one flexible support arm cooperating with a flexible positioning arm to secure the distal end opening of the catheter against the wall of the blood vessel refers to the at least one flexible support arm and the flexible positioning arm moving or functioning together to lock, secure, settle, secure, or otherwise enable or maintain contact between the distal end opening and the wall. Examples of such cooperation include the at least one flexible support arm and the flexible positioning arm moving, rotating, extending, folding, twisting, or pressing against the wall to maintain the position of the distal end opening relative to the wall. For example, in FIG. 1, flexible support arm 112 and flexible positioning arm 116 are both in an extended orientation such that flexible support arm 112 and flexible positioning arm 116 press against wall 124. The airtight seal created by flexible support arm 112 and flexible positioning arm 116 of FIG. 1 pressing against wall 124 holds distal end opening 126 in place against wall 124 .

[0029] Consistent with some disclosed embodiments, at least two flexible support arms are configured to cooperate with the flexible positioning arm to secure the open distal end of the second catheter against the wall of the blood vessel. "At least two flexible support arms" refers to two or more flexible support arms of the same or different types. Examples of "at least two flexible support arms" include one arm shaped as a wing and the other arm shaped as a rod, both arms shaped as wings, or three arms including a wing, a rod, and a flat sheet. In another example, "at least two flexible support arms" includes two similar flexible support arms. The arms are configured to cooperate when they collectively engage the blood vessel wall to stationary or secure the open distal end against the blood vessel wall. "Securing" in this context refers to support, stabilization. Three-point coordination, for example, may involve three separate arms engaging the blood vessel wall at three different locations to stabilize the position of the open distal end. Cooperation may refer to working together to create a friction fit, interference fit, brace, or wedge within the vessel. In some embodiments, the flexible support arms may have a larger contact surface, such as a wider or more extensive surface, to increase contact with the vessel wall. In other embodiments, an increased number of flexible support arms or other structures may be used to improve fixation purposes. FIG. 4 shows an example of a three-point arrangement, in which a positioning arm 400 is assisted by a first flexible support arm 402 and a second flexible support arm 410 to fix the open distal end 404 of the second catheter against the vessel wall 406. In this example, the three arms 400, 402, and 410 press firmly against the wall 406 with a friction or interference fit.

[0030] Consistent with some disclosed embodiments, the flexible positioning arm includes an orifice therein, and the open distal end of the second catheter is connected to the orifice. An orifice refers to an opening, a hole, or a bore. Examples of an orifice include an inlet, a mouth, a gap, a perforation, a slit, a cavity, a slot, or an orifice. For example, in FIG. 4 , the flexible positioning arm 412 includes an orifice 416 in the shape of a circular opening. The flexible positioning arm may include a puncture positioning structure, which defines the orifice and has a two-dimensional surface facing the target wall in the expanded orientation. The open distal end 404 of the second catheter is connected to or contiguous with the orifice 416. This connection can be achieved in any manner, including bonding, welding, adhesive bonding, integral formation, mechanical attachment, or any other method of adhesion or joining. The open distal end may be formed in various shapes, such as oval, circular, or rectangular. In such examples, the orifice may be shaped to correspond to or otherwise connect to an oval, circular, or rectangular open distal end. In the example shown in FIG. 1, the open distal end 126 is connected to the orifice 114 by the orifice being disposed around the open distal end 126. As one example, the connection shown in FIG. 1 may be a mechanical link or a weld between the open distal end 126 and the orifice 114. As another example, the connection shown in FIG. 1 may include an adhesive that attaches the open distal end 126 to the orifice 114. In another example, the open distal end 126 and the orifice are a single unit or a continuous portion.

[0031] Consistent with some disclosed embodiments, the second catheter includes a proximal end configured to allow axial movement of the open distal end. Being configured to allow axial movement can occur in any number of ways, such as the proximal end extending from a sheath and / or being engaged with a control means (e.g., a control handle). Consistent with some disclosed embodiments, the second catheter includes a proximal end configured to allow control of the open distal end extending from a sheath. The proximal end extending from the sheath includes an end positioned in a direction opposite the distal end that protrudes, emanates from, or is otherwise spaced apart from the sheath. Examples of a proximal end extending from a sheath include an end of the second catheter opposite the distal end protruding from the sheath and a portion of the second catheter facing in a direction opposite the distal end that is spaced a distance from the sheath entrance. During a procedure, the proximal end can be located outside the body, providing the surgeon with the ability to control the distal end by manipulating the proximal end. For example, FIG. 1 shows a control handle 110 connected to the proximal end of the second catheter 104 for radial and axial control of the second catheter 104. In this example, a control device 140 is connected to the proximal end of the second catheter 104 and protrudes from the sheath 106. A proximal end configured to allow control of the open distal end refers to the proximal end allowing management, adjustment, or direction of the movement or function of the open distal end. Examples of a proximal end configured to allow control of the open distal end include electrical or mechanical control of the movement, angle, attachment, speed, flexion, extension, or rotation of the open distal end. For example, in FIG. 1, the proximal end 111 of the second catheter 104 may control the radial movement of the open distal end 126 around the circumference of the wall 124 by controlling the rotation of the open distal end 126.

[0032] Consistent with certain disclosed embodiments, the flexible positioning arm and the at least one flexible support arm are configured to fold and expand radially relative to the central axis of the system. Configuring the flexible positioning arm and the at least one flexible support arm to fold and expand radially relative to the central axis of the system refers to the arms being configured to move radially inward and outward relative to the central axis of the sheath. Examples of arms configured to fold and expand in this manner include arms that bend, such as arms made of shape-memory or other bendable materials. In alternative embodiments, hinged connections, swivels, or other flexible mechanical connections may be used, as long as they are biocompatible. For example, in FIG. 2B , the flexible positioning arm 200 and the flexible support arm 202 are configured to open and close toward the central axis 208. In this example, the flexible positioning arm 200 and the flexible support arm 202 may be constructed from a foldable and expandable Nitinol material or frame.

[0033] Consistent with certain disclosed embodiments, at least one flexible support arm and one flexible positioning arm cooperate in their respective extended orientations to engage the wall at different locations. Cooperation of at least one flexible support arm and one flexible positioning arm in their respective extended orientations to engage the wall at different locations refers, as previously mentioned, to the at least one flexible support arm and one flexible positioning arm moving or functioning together to contact, touch, or interact with the wall at dissimilar locations. Examples of cooperation of at least one flexible support arm and one flexible positioning arm in this manner include extending the at least one flexible support arm and one flexible positioning arm the same distance away from the central axis, extending the at least one flexible support arm and one flexible positioning arm the same angle away from the central axis, or controlling the movement or positioning of one of the at least one flexible support arm and one flexible positioning arm based on the other's engagement with the wall. For example, in FIG. 4 , flexible support arm 402 and flexible positioning arm 400 cooperate in their respective extended orientations relative to each engaging wall 406 at different locations 414 and 412. The different locations may relate to different circumferential positions along the wall. In this example, flexible support arm 402 and flexible positioning arm 400 may cooperate by extending in different directions from the collapsed orientation at a common distance relative to the central axis. As another example, flexible support arm 402 and flexible positioning arm 400 may cooperate by extending away from the collapsed orientation at a common rate.

[0034] Consistent with certain disclosed embodiments, the open distal end is adjustable between 0 and 180 degrees relative to the elongate axis of the system by axial movement of the second catheter relative to the first catheter. The open distal end may be adjustable between 0 and 150 degrees relative to the elongate axis of the system. An open distal end adjustable between 0 and 180 degrees relative to the elongate axis of the system by axial movement of the second catheter relative to the first catheter refers to a configuration in which linear or translational movement of the second catheter relative to the first catheter influences, adjusts, or otherwise affects the angle of the open distal end within a range of 0 to 180 degrees. For example, when the second catheter is moved linearly (e.g., within the first catheter) with its open end connected to the adjustable arm, the orientation of the angled open distal end changes. Because the distal end is constrained by the flexible arm, advancing the second catheter distally causes the catheter to bend toward the wall of the blood vessel. Examples of such adjustable angles include moving the second catheter within the first catheter to change the angle, moving both the first and second catheters to change the angle, or relative movement of the second catheter affecting movement of another component operably connected to the open distal end, such as a flexible positioning arm, thereby adjusting the angle of the open distal end. For example, in FIG. 8A , axial movement 806 of the second catheter 812 relative to the first catheter 810 causes bending of the second catheter 812 to adjust the angle of the open distal end 804 between 0 and 180 degrees relative to the elongate shaft 802. As shown in FIG. 8B , such axial movement 806 of the second catheter 812 may be used to position the open distal end 804 against a tissue wall 808. In some embodiments, the second catheter is configured to form a bend radius of less than 6 mm. In some embodiments, the at least one flexible support arm and the second catheter are configured to cooperate to form a bend radius of less than 4 mm and to cooperate with the tissue piercer to enable tissue puncture with a bend radius of less than 4 mm.

[0035] Some disclosed embodiments include an elongated shaft that can extend through a second catheter. An elongated shaft that can extend through a second catheter refers to an elongated rod, cylinder, or tubular structure having a length greater than its diameter and configured to be inserted, positioned, or otherwise disposed within the second catheter. Such an elongated shaft allows a tissue piercer to be inserted through the second catheter using a tool configured to be inserted and withdrawn through the lumen of the shaft to reach or access specific locations within the body, or to perform specific tasks requiring precise control over the length or reach of the shaft, such as the delivery of a guidewire after puncture. The elongated shaft also allows for control (e.g., mechanical control) by an operator or surgeon from the opposite or proximal end. Examples of elongated shafts that can extend through a second catheter include a conduit within the second catheter, a guidewire, a tubular cylindrical structure within the second catheter, or a lumen of any cross-sectional shape within the second catheter. As one example, FIG. 3 illustrates the internal structure of an exemplary second catheter consistent with embodiments of the present disclosure. In this example, the second catheter 300 includes a tube-shaped elongated shaft 302 that extends inside the second catheter 300. The elongated shaft 302 may be used to insert or control a tool, such as a tissue piercer 304, within the second catheter 300.

[0036] Consistent with certain disclosed embodiments, at least one controller is configured for radial and axial manipulation of each of the elongate shaft, the first catheter, and the second catheter. The at least one controller includes any device, interface, or manually operable control configured to adjust, orient, or position in at least two degrees of freedom (i.e., radial and axial). Examples of such controllers include hardware and / or software interfaces. Such controllers may include one or more of handles, levers, dials, wheels, screws, locks, and / or any other mechanical or electrical actuators. For example, FIG. 6 illustrates an example of an endoluminal puncture system 600 having a controller 602 for radial and axial manipulation of each of the elongate shaft 604, the first catheter 606, and the second catheter 608, consistent with embodiments of the present disclosure. In this example, the controller 602 may be a single robotic controller configured to control the radial and axial movement of the elongate shaft 604, the first catheter 606, and the second catheter 608. As another example, the control device 602 may include a lever for controlling the movement of the elongate shaft 604, a handle for controlling the movement of the first catheter 606, and an electronic control for controlling the movement of the second catheter 608. Alternatively, as shown in FIG. 1, the controller 110 may include a handle that may include one or more knobs, buttons, or levers for individually controlling different degrees of freedom of movement. In the simplest example, turning the handle may control the radial orientation of the opening 126, and radial movement of the handle relative to a sheath adjacent the handle may control the angle of incidence of the opening 126 with respect to the vessel wall.

[0037] Consistent with certain disclosed embodiments, the at least one control device further includes a lock configured to prevent radial or axial manipulation of at least one of the elongate shaft, the first catheter, and the second catheter. A lock configured to prevent radial or axial manipulation of at least one of the elongate shaft, the first catheter, and the second catheter refers to a device or system configured to limit or inhibit radial or axial movement. Examples of locks include mechanical fixation devices that prevent relative movement (either axial or radial) of one catheter with respect to the other. Other examples of locks include electronic locking interfaces, torque control devices, fixed-length catheters, guidewire locks, locking hubs or connectors, screws, position locking rings, and magnetic locks. For example, in FIG. 6, the control device 602 may be an electronic controller configured to control the radial and axial movement of the elongate shaft 604, the first catheter 606, and the second catheter 608. In this example, the controller 602 may include software instructions that prohibit further radial and axial manipulation once a particular position or angle is achieved by any of the elongate shaft, the first catheter, and the second catheter.

[0038] Some disclosed embodiments include a tissue piercer located at the distal end of the elongate shaft, configured to advance axially within the second catheter and operably connected to the open distal end of the second catheter. A tissue piercer refers to any device or component configured to puncture, cut, penetrate, ablate (e.g., chemically, laser, or cryoablation), or otherwise create a hole, incision, erode, chip, vaporize, or break in tissue. A location on the distal end of the elongate shaft refers to a location on the furthest or outermost region of the elongate shaft. Examples of tissue piercers include needles, blades, lancets, sharp edges, or any other structure capable of piercing tissue. For example, in FIGS. 1 and 3 , each tissue piercer 118 and 304 is shaped as a needle (the needle can be pointed or blunt-tipped, as long as it is capable of piercing tissue). The tissue piercer being configured to advance axially within the second catheter refers to the tissue piercer being shaped or positioned to be inserted into and moved in a single file within the second catheter. Examples of the tissue piercer being configured to advance axially within the second catheter include the tissue piercer sliding within the lumen of the second catheter or the tissue piercer following the curve of the second catheter through an elongate shaft within the second catheter. For example, in FIG. 3 , the tissue piercer 304 may be moved within the second catheter 300 by pushing or pulling the tissue piercer 304 inside the elongate shaft 302. This may occur, for example, by operating a lever or other advancement mechanism on the control device 110 ( FIG. 1 ). The tissue piercer being operably connected to the open distal end of the second catheter refers to a functional relationship or connection between the tissue piercer and the open distal end of the second catheter that configures the tissue piercer and the open distal end to work together or to move or function in a coordinated manner.Examples of operably connecting a tissue piercer to the open distal end of the second catheter include connecting the two structures such that movement of the open distal end affects movement of the tissue piercer, or such that movement of the tissue piercer affects movement of the open distal end, either through connection of the two structures or through coordinated movement or operation of the two structures. For example, in FIG. 1 , open distal end 126 houses tissue piercer 118 such that when the open distal end faces wall 124, tissue piercer 118 is positioned to penetrate wall 124 and puncture anatomical vessel 122. Puncturing may be accomplished when a needle is advanced, such as by control on handle 110 or in control unit 602. In some embodiments, the tissue piercer may be or include a needle, hollow tube, or wire. In some embodiments, the tissue piercer may have an outer diameter of less than 4 mm, 3 mm, 2 mm, 1 mm, or 0.5 mm.

[0039] Consistent with some disclosed embodiments, the elongate shaft includes a proximal end extending from the second catheter and configured to enable control of the tissue piercer. The proximal end extending from the second catheter includes an end opposite the distal end of the second catheter that protrudes, emanates, or is otherwise spaced apart from the second catheter. Examples of proximal ends extending from a catheter include an end of an elongate sheath that is opposite the distal end of the second catheter and protrudes from the second catheter, and a portion of the elongate sheath that faces away from the distal end of the second catheter and is spaced a distance from the inlet of the second catheter. For example, FIG. 1 illustrates a control device 110 for radial and axial control of the second catheter 104. As an example, the control device 110 may be configured to manipulate the proximal end of the elongate sheath 106 that houses the first catheter 102 and the second catheter 104. Additionally or alternatively, the control device 110 may be configured to operate a proximal end of the first catheter 104 or the first catheter 102, which may protrude from the sheath 106. The proximal end being configured to allow control of the tissue piercer refers to the proximal end being configured to allow manipulation of the tissue piercer. Examples of the proximal end being configured to allow control of the tissue piercer include electrical or mechanical control of the movement, angle, attachment, speed, bending, extension, or rotation of the tissue piercer. For example, in FIG. 1 , the controller 110 may control the movement of the tissue piercer 118 along the length of the wall 124 by controlling the bending or angle of the tissue piercer 118.

[0040] Consistent with certain disclosed embodiments, the tissue piercer includes a sharp edge or blade configured to pierce tissue. A sharp edge or blade configured to pierce tissue refers to any cutting, penetrating, or pointed structure configured to penetrate or incise tissue, such as skin, muscle, blood vessels, or organs. Examples of sharp edges configured to pierce tissue include scalpels, needles, and serrated surfaces. Examples of sharp edges include straight blades, serrated blades, dropping point blades, clip point blades, tanto blades, boi blades, hackbill blades, spy blades, blunt tip needles, and needle point blades. For example, FIG. 5 illustrates an example of an intraluminal piercing system 500 having a sharp tissue piercer 502 consistent with certain embodiments of the present disclosure. In this example, the tissue piercer 502 has a flat shape with a beveled edge, forming a sharp surface that facilitates piercing tissue.

[0041] Consistent with certain disclosed embodiments, a dilator is configured to dilate the opening in the vessel wall caused by the tissue puncture. A dilator configured to dilate the opening in the vessel wall refers to a structure or device configured to further open, enlarge, or widen the opening to accommodate the insertion of another medical instrument or tool. Examples of dilators include a Seldinger dilator, a valve rotome, a balloon, an expanding stent, or any other structure that expands and widens the opening when received in the opening. For example, FIG. 5 shows an example of a balloon dilator 504 configured to dilate the opening in the vessel wall 506 caused by the tissue puncture 502. In this example, the balloon dilator 504 may be incorporated into any portion of the endoluminal puncture system 500, such as the elongate shaft or the distal tip of a second catheter. Once the tissue puncture device 502 has created an opening in the vessel wall 506 by cutting into it, the balloon expander 504 may be inflated, such as by actuating an integrated inflation port that allows inflation with a syringe, or by injecting sterile saline or contrast dye into the balloon through the elongate shaft. As the balloon expander 504 expands, it expands radially, pressing against the opening in the vessel wall 506 and further widening the opening. Control of the expander may be via a controller 110 or 602, as shown in Figures 1 and 6, respectively.

[0042] Consistent with certain disclosed embodiments, the dilator is configured to be delivered over an elongate shaft. Configuring a dilator for delivery over an elongate shaft refers to the dilator being shaped or positioned to be introduced or delivered to a particular location or anatomical structure by being advanced or inserted over the shaft. Examples of dilators configured for delivery over an elongate shaft include introducing the dilator over the elongate shaft and designing the shaft with the dilator configured to move up and down the exterior of the shaft. Such movement can occur by pushing a guidewire connected to the structure to which the balloon dilator is attached. Such movement may be controlled via a standalone guidewire or via the controller 110 or 602. Alternatively, the dilator may be pre-positioned adjacent to the puncture device. In one embodiment, the dilator may be movable with the puncture device to enter the puncture site following the initial puncture as the dilator is advanced. FIG. 3 shows an example of a dilator 306 in the form of an inflatable balloon configured to be delivered over an elongate shaft 302. In this example, a dilator 306 may be advanced over the elongate shaft 302 from the proximal end of the second catheter 300 .

[0043] Consistent with some disclosed embodiments, the hollow tube in the second catheter is configured to function as a placeholder during replacement of the puncture device with a guidewire. Replacing the puncture device with a guidewire refers to replacing or exchanging the puncture device with a long, thin, or flexible wire or tube configured for insertion into the body. The use of a placeholder during replacement of the puncture device can be important immediately after puncturing the hole and before placing a medical device, such as a shunt, in the puncture hole. Examples of replacing the puncture device with a guidewire include axially sliding the hollow tube over the puncture device, partially retracting the puncture device within the hollow tube, sliding the guidewire through, along, or over the puncture device and through the hollow tube, and optionally completely retracting the tissue puncture device from the system. The hollow tube in the second catheter is configured to function as a placeholder during replacement of the puncture device with a guidewire. A hollow tube refers to a tubular or elongated three-dimensional structure having a hollow, hollow, perforated, or sunken interior. Examples of hollow tubes include round, rectangular, square, oval, triangular, hexagonal, octagonal, teardrop, D-shaped, and C-shaped tubes. For example, FIG. 7 illustrates an exemplary hollow tube 704 within a second catheter 708 configured to serve as a placeholder while the puncturer 702 is replaced with a guidewire 706, consistent with certain embodiments of the present disclosure. In one example, the hollow tube 704 may be a cylindrical tube disposed at the distal end of the second catheter 708. In other embodiments, the hollow tube 704 may be disposed in other locations or extend along the length of the second catheter 708. As one example, the puncturer 702 may be replaced with the guidewire 706 by withdrawing the puncturer 702 from the second catheter 708 and then inserting the guidewire 706 into the second catheter 708. In this example, hollow tube 704 may hold the distal end of second catheter 708 open or wide enough for guidewire 706 to be inserted. As another example, hollow tube 704 may be retracted after replacing piercer 702 with guidewire 706.In some embodiments, hollow tube 704 may be used to introduce or retrieve other structures. In other embodiments, hollow tube 704 may be configured as a dilator. In this embodiment, following replacement of the puncture device with hollow tube 704, the hollow tube may be dilated or inflated to dilate the puncture hole, for example, prior to deploying a shunt.

[0044] Consistent with certain disclosed embodiments, the angle of the open distal end is adjustable between 0 and 180 degrees relative to the central axis of the system to enable tissue puncture at a selected angle between 0 and 150 degrees. Adjusting the angle of the open distal end between 0 and 180 degrees relative to the central axis to enable tissue puncture at a selected angle between 0 and 150 degrees refers to the angle being variable, adaptable, or otherwise changeable relative to the central axis within the range of 0 and 180 degrees so that tissue can be cut, incised, or drilled at a desired angle within the range of 0 and 150 degrees. Examples of the angle of the open distal end being adjustable in this manner include the open distal end being variable between 0 and 180 degrees, or a connected structure, such as a second catheter, being configured to move the open distal end between positions corresponding to angles between 0 and 180 degrees. For example, FIGS. 8A and 8B show an example of an endoluminal puncture system 800 before and after tissue puncture, consistent with embodiments of the present disclosure. 8A, the angle of the open distal end 804 of the second catheter 812 is adjustable between 0 and 180 degrees relative to the central axis 802 to enable puncture of the tissue wall 808 at a selected angle between 0 and 150 degrees. In this example, the angle of the open distal end 804 of the second catheter 812 may be adjustable by moving the second catheter 812 toward or away from the tissue wall 808.

[0045] Consistent with certain disclosed embodiments, the distal end of the second catheter is configured to bend toward the wall to allow the tissue piercer to puncture the wall at a right angle. Configuring the second catheter to bend toward the wall to allow the tissue piercer to puncture the wall at a right angle refers to the second catheter bending or curving so that the tissue piercer is positioned or angled to puncture the wall vertically or at a right angle. Such bending mechanisms are discussed elsewhere herein. Examples of configuring the second catheter to bend in this manner include rotating, bending, pivoting, folding, or curling the second catheter while it is operably connected to the tissue piercer. For example, in FIG. 8A , the second catheter 812 may be configured to bend left or right 814 of its central axis to allow the tissue piercer 816 to puncture the wall 808 at a right angle. In this example, the second catheter 812 may be made of a bendable material. Bending can occur as a result of advancement of second catheter 812 along axis 802. Because the connection between opening 804 and flexible positioning arm 818 limits the axial movement of open end 804, axial advancement of second catheter 812 bends second catheter 812, thereby moving opening 804 toward vessel wall 808.

[0046] Consistent with certain disclosed embodiments, the at least one flexible support arm is configured to be positioned relative to the wall to allow the tissue piercer to pierce the wall at a right angle. This refers to the at least one flexible support arm being movable or adjustable relative to the wall so that the tissue piercer can be positioned or angled to pierce the wall perpendicularly or at a right angle. Blood vessels do not always extend in a straight line, and therefore, reference to orthogonal is not meant to imply a perfect 90-degree puncture every time. Rather, orthogonal in this context generally refers to piercing the wall head-on, rather than intentionally piercing at an obviously acute angle. Examples of configuring the at least one flexible support arm to be positioned relative to the wall to allow the tissue piercer to pierce the wall at a right angle include rotating, bending, pivoting, folding, or curling the at least one flexible support arm. 1, flexible support arm 116 may be configured to expand and press against wall 124 to allow tissue piercer 118 to pierce wall 124 at a right angle. In this example, the pressure of flexible support arm 116 against wall 124, in addition to the pressure of flexible positioning arm 112, holds system 100 in place, allowing the tissue piercer to pierce wall 124 at a right angle.

[0047] Some disclosed embodiments include a method for puncturing the wall of an anatomical vessel. A method for puncturing the wall of an anatomical vessel refers to any procedure or technique used to create an intentional opening or penetration in the wall of a biological vessel within the human body. FIG. 9 is a flowchart of an exemplary process 900 for puncturing the wall of an anatomical vessel, consistent with some embodiments of the present disclosure. Process 900 is not limited to any particular structure other than those listed in the flowchart. As an example, this process may be performed by an endoluminal puncture system (e.g., endoluminal puncture system 100 of FIG. 1 , endoluminal puncture system 500 of FIG. 5 , endoluminal puncture system 600 of FIG. 6 , endoluminal puncture system 700 of FIG. 7 , or endoluminal puncture system 800 of FIG. 8 ) to perform the operations or functions described herein. Consistent with some disclosed embodiments, the anatomical vessel includes a coronary sinus. For example, anatomical vessel 122 shown in FIG. 1 may be the coronary sinus, and wall 124 is the wall of the coronary sinus.

[0048] Some disclosed embodiments include advancing a flexible catheter having an open distal end within an anatomical vessel. Referring to FIG. 9 , process 900 includes step 902 of advancing a flexible catheter having an open distal end within an anatomical vessel. A flexible catheter refers to a catheter, as previously described and illustrated, that is configured to bend or conform to a curve or passageway within the body. An open distal end may be understood as previously described and illustrated with respect to a second catheter having an open distal end. Advancing a flexible catheter having an open distal end within an anatomical vessel refers to moving or navigating a flexible catheter (i.e., a second catheter having a bendable distal catheter) into the anatomical vessel through a natural or surgically formed opening. Examples of advancing a catheter include inserting a catheter into the anatomical vessel and guiding the catheter within the anatomical vessel. For example, FIGS. 10A-10D illustrate an example of a method for puncturing a wall of an anatomical vessel, consistent with some embodiments of the present disclosure. In Figure 10A, a flexible catheter 1000 having an open distal end 1002 may be guided into an anatomical vessel 1004, such as a blood vessel. The flexible catheter 1000 may be incorporated into an endoluminal puncture system such as those previously described and illustrated, including the endoluminal puncture system 100 of Figure 1, the endoluminal puncture system 500 of Figure 5, the endoluminal puncture system 600 of Figure 6, the endoluminal puncture system 700 of Figure 7, and the endoluminal puncture system 800 of Figure 8. The flexible catheter 1000 may be further understood in light of the previously described and illustrated figures. For example, the flexible catheter 1000 may be equivalent to the second catheter 104 of the endoluminal puncture system 100 of FIG. 1, the second catheter 608 of the endoluminal puncture system 600 of FIG. 6, the second catheter 708 of the endoluminal puncture system 700 of FIG. 7, or the second catheter 812 of the endoluminal puncture system 800 of FIG. 8.

[0049] Some disclosed embodiments include manipulating the open distal end so that it faces a target location on a wall of an anatomical vessel. Referring to FIG. 9 , process 900 includes step 904 of manipulating the open distal end so that it faces a target location on a wall of an anatomical vessel. The target location refers to a specific point, location, or site for an intended purpose, such as puncture. Examples of target locations on a wall of an anatomical vessel include a point on the wall, a side of the wall, a cross-section of the wall, or a location corresponding to a type of tissue on the wall. Alternatively, the target location may correspond to an organ outside the vessel at the target location. In some use cases, the perforation forms an opening both in the vessel wall and in an adjacent organ. In FIGS. 10A-10B , target location 1006 is shown as a region of wall 1004. Having the open distal end facing the target location refers to the open distal end being positioned or oriented to face or be directed toward the target location. Examples of the open distal end facing the target location include the open distal end facing the target location, the open distal end extending toward the target location, or the open distal end being positioned near the target location. For example, in FIG. 10B , the open distal end 1002 may face the target location 1006 by facing it. Manipulating the open distal end so that it faces the target location on the wall of an anatomical vessel refers to adjusting or positioning the open distal end. Examples of manipulating the open distal end include moving the open distal end axially, changing the angle of the open distal end or its flat surface, or extending the configuration of the open distal end relative to the central axis of the system (i.e., changing the angle of its flat surface). For example, the open distal end 1002 in FIG. 10A may be manipulated by axial and radial movement of a second catheter, which is further secured to or operably connected to the first catheter (or its orifice). This axial and radial movement allows controlled movement toward a target location 1006 such that the open distal end 1002 faces the target location 1006 on the wall 1004, as shown in FIG. 10B.

[0050] Consistent with certain disclosed embodiments, manipulating the open distal end includes bending a flexible positioning arm to which the distal open end is connected. The flexible positioning arm may be understood as previously described and illustrated. For example, FIG. 1 shows an example of a flexible positioning arm 112 to which the distal open end 126 is connected. Bending the flexible positioning arm may include changing the shape or orientation of the flexible positioning arm. Examples of bending the flexible positioning arm include curving, bending, twisting, folding, extending, or rotating the flexible positioning arm, regardless of the mechanism of manipulation. For example, in FIG. 8A , the open distal end 804 is connected to a flexible positioning arm 818. In this example, bending the flexible positioning arm 818 away from the central axis 802 may reposition the open distal end 804 so that it faces the vessel wall 808, as shown in FIG. 8B . In some embodiments, the step of manipulating the open distal end may include expanding the flexible positioning arm by bending or curving the flexible positioning arm as it transforms from a straight configuration to a bent or curved configuration.

[0051] Consistent with certain disclosed embodiments, the manipulating step includes adjusting the angle of the open distal end. Adjusting the angle of the open distal end refers to changing the orientation or alignment of the open distal end relative to the central axis. Examples of adjusting the angle of the open distal end include moving the open distal end by manual control of the flexible catheter or by an electronic controller configured to control movement of the flexible catheter. For example, the open distal end 1002 of FIG. 10A may be manipulated by increasing the angle of the open distal end 1002 relative to the central axis of the flexible catheter to a larger angle, as shown in FIG. 10B. In this example, increasing the angle of the open distal end 1002 may be achieved by pushing the flexible catheter 1000 or by moving a connecting structure, such as the expandable arm 1005. In another example, increasing the angle of the open distal end 1002 may be achieved by removing a sheath to expand a portion of the expandable arm 1005 and pushing the flexible catheter 1000.

[0052] Consistent with certain disclosed embodiments, the step of manipulating includes adjusting the angle of the flexible positioning arm. Adjusting the angle of the flexible positioning arm refers to changing the orientation or alignment of the flexible positioning arm. Examples of adjusting the angle of the flexible positioning arm include moving the flexible positioning arm by manual control of the flexible catheter or flexible positioning arm (e.g., by using a handheld controller such as controller 110 of FIG. 1 ) or by an electronic controller configured to control movement of the flexible catheter or flexible positioning arm (e.g., through the use of any other controller, electronic or otherwise, such as controller 602 of FIG. 6 ). For example, flexible positioning arm 200 of FIG. 2A may be adjusted to a wider angle away from central axis 208 by being pulled outward from central axis 208, as shown in FIG. 2B . Adjusting the angle of the flexible positioning arm may include adjusting the positioning of a puncture positioning structure, such as puncture positioning structure 113 of FIG. 1 . For example, the puncture positioning structure 113 may be moved outward from the central axis of the system 100 to adjust the angle of the flexible positioning arm 112, or the puncture positioning structure 113 may be moved radially by rotating the first catheter 102.

[0053] Consistent with some disclosed embodiments, the manipulating step includes adjusting the distance of the open distal end from the wall. Adjusting the distance of the open distal end from the wall refers to changing the spacing or proximity between the open distal end and the wall. Examples of adjusting the distance of the open distal end from the wall refer to moving the open distal end radially away from the wall or moving the open distal end axially away from the wall. For example, the distance of the open distal end 1002 from the wall 1004 in FIG. 10A may be reduced by moving the open distal end 1002 closer to the wall 1004, as shown in FIG. 10B.

[0054] Consistent with certain disclosed embodiments, the manipulating step includes adjusting the distance of the flexible positioning arm from the wall. Adjusting the distance of the flexible positioning arm from the wall refers to changing the spacing or proximity between the flexible positioning arm and the wall. Examples of adjusting the distance of the flexible positioning arm from the wall include pulling the flexible positioning arm radially away from the wall or moving the flexible positioning arm axially away from the wall. For example, the flexible positioning arm 200 of FIG. 2A may be adjusted to be closer to the surrounding wall by being pulled outward from the central axis 208, as shown in FIG. 2B.

[0055] Consistent with certain disclosed embodiments, the manipulating step includes axial or radial manipulation of the flexible catheter. Axial or radial manipulation of the flexible catheter includes managing, adjusting, or directing the movement or function of the flexible catheter along or perpendicular to the central axis. Examples of axial or radial manipulation of the flexible catheter include sliding the flexible catheter up or down, rotating the flexible catheter, bending the flexible catheter, or twisting the flexible catheter. For example, the flexible catheter 1000 of FIG. 10A may be pushed distally so that the open distal end 1002 faces the target location 1006 on the wall 1004, as shown in FIG. 10B.

[0056] Some disclosed embodiments include bracing the open distal end within the vessel to limit movement of the open distal end. The bracing step may include any form of fixation. Examples include three-point positioning, interference fitting, or wedging. With reference to FIG. 9 , process 900 includes step 906 of bracing the open distal end within the vessel to limit movement of the open distal end. Limiting movement of the open distal end refers to limiting, controlling, or preventing movement of the open distal end. Examples of limiting movement of the open distal end include locking the open distal end in position or limiting the range of movement of the open distal end by one of the techniques discussed above. For example, movement of the open distal end may be axially limited by blocking axial movement of the flexible catheter at one or more locations. Bracing the open distal end within the vessel to limit movement of the open distal end refers to supporting or stabilizing the distal end within the vessel. In some embodiments, bracing the open distal end within the vessel may also or alternatively include using a primed flexible arm, an anchor, an inflatable balloon, or a hook. As one example, the flexible positioning arm is secured to the open distal end of the second catheter such that, when the flexible positioning arm is in an extended orientation, the open distal end is braced within the anatomical vessel. In this manner, the open distal end is at the distal end of the flexible catheter, which is fixed in place by a puncture positioning structure 113 defining an orifice 114 within the second catheter 104. In another example, bracing the open distal end within the vessel may include inflating an inflatable balloon near the open distal end. In this example, the expanded balloon may exert pressure against the vessel wall, maintaining the open distal end in place.

[0057] Consistent with some disclosed embodiments, the bracing step includes expanding multiple flexible braces against different locations on the vessel wall. Multiple flexible braces refer to two or more support structures or components configured to provide stability, reinforcement, or flexibility. Examples of flexible braces include wings, flaps, arms, or any other structure mentioned herein. For example, in FIG. 4 , the multiple flexible braces may include first flexible support arm 402 and second flexible support arm 410. Expanding the multiple flexible braces against different locations on the vessel wall refers to expanding or spreading the flexible braces toward or contacting various locations or regions on the vessel wall. Examples of expanding the multiple flexible braces against different locations on the vessel wall include the braces opening outward, changing shape, or being pulled toward the vessel wall. For example, as shown in FIG. 4, the first flexible support arm 402 and the second flexible support arm 410 may open toward different positions on the vessel wall 406 by moving them away from the central axis of the endoluminal puncture system.

[0058] Some disclosed embodiments include advancing a tissue piercer through a flexible catheter to puncture the wall of an anatomical vessel at a target location. Referring to FIG. 9 , process 900 includes step 908 of advancing a tissue piercer through a flexible catheter to puncture the wall of an anatomical vessel at a target location. The tissue piercer may be understood as previously described and illustrated. For example, FIG. 10D shows an example of a tissue piercer 1008 in the form of a needle. Advancing a tissue piercer through a flexible catheter to puncture the wall of an anatomical vessel at a target location refers to moving or advancing the tissue piercer within the flexible catheter to puncture the wall or delivering the tissue piercer to a position that allows the tissue piercer to puncture the wall at the target location. Examples of advancing a tissue piercer through a flexible catheter include inserting the tissue piercer into the flexible catheter and / or guiding at least a portion of the tissue piercer within the flexible catheter. 10D , tissue piercer 1008 may be advanced through flexible catheter 1000 to target location 1006 to puncture wall 1004 at target location 1006. The tissue piercer may be pre-positioned within flexible catheter 1000 such that advancing involves only a relatively short movement through opening 1002.

[0059] Consistent with certain disclosed embodiments, the tissue lancet includes a needle. A needle refers to an elongated, pointed, or cylindrical device, whether or not it is pointed. Examples of needles include a round needle, a tapered needle, a cutting needle, a reverse-cutting needle, a tapered cutting needle, a spatula needle, or a blunt-tip needle. For example, FIG. 1 shows a tissue lancet 118 shaped as a round needle. In some embodiments, the tissue lancet may include a hollow tube. In some embodiments, the tissue lancet may have a diameter of less than 20 mm, 10 mm, or 7 mm. In some embodiments, the tissue lancet may include a sharp blade.

[0060] Consistent with certain disclosed embodiments, the method includes dilating an opening in the wall of an anatomical vessel caused by a tissue puncture instrument. Dilating an opening in the wall of an anatomical vessel caused by a tissue puncture instrument refers to enlarging or widening a hole, perforation, or incision caused by the tissue puncture instrument. Examples of dilating an opening in the wall of an anatomical vessel caused by a tissue puncture instrument include widening or widening a Seldinger dilator, a valve rotome, a balloon, an expanding stent, and / or any other structure capable of widening a hole in tissue. FIG. 5 illustrates an example of dilating an opening in a vessel wall 506 caused by a tissue puncture instrument 502. In this example, the balloon dilator 504 may be incorporated into any portion of the endoluminal puncture system 500, such as the elongate shaft or the distal tip of a second catheter. Once the tissue puncture device 502 has created an opening in the vessel wall 506 by cutting into it, the balloon expander 504 may be inflated, such as by activating an integrated inflation port that allows inflation with a syringe, or by injecting sterile saline or contrast dye into the balloon through the elongate shaft. As the balloon expander 504 expands, it expands radially, pressing against the opening in the vessel wall 506 and further widening the opening.

[0061] Consistent with certain disclosed embodiments, dilating includes advancing a dilator over the tissue piercer. The dilator may be understood as previously described and illustrated. For example, FIG. 3 shows a dilator 306 in the form of an inflatable balloon. Advancing the dilator over the tissue piercer refers to introducing or delivering the dilator around or outside the tissue piercer. Examples of advancing the dilator over the tissue piercer include the dilator being introduced over the tissue piercer or the tissue piercer being designed with the dilator moving up and down the outside of the tissue piercer. For example, in FIG. 3 , the dilator 306 may be an inflatable balloon advanced over the elongate shaft 302. In this example, the dilator 306 may be advanced over the tissue piercer 304.

[0062] Consistent with certain disclosed embodiments, the method includes positioning a tissue piercer near a target location by expanding multiple extendable arms on the distal end of a first catheter. The multiple extendable arms refer to two or more structures configured to extend beyond their current state. Examples of multiple extendable arms include bendable, malleable, flexible, or otherwise yielding rods, wings, stents, articulations, or any other structures mentioned herein. For example, expanding the multiple extendable arms on the distal end of the first catheter may refer to transitioning between the collapsed orientation of FIG. 2 and the expanded configuration of FIG. 4, where the flexible positioning arm 412 (optionally the first flexible support arm 402 and the second flexible support arm 410) are on the distal end of the first catheter 418. Positioning the tissue piercer near the target location by expanding the multiple expandable arms on the distal end of the first catheter refers to extending or widening the expandable arms to move or pivot the tissue piercer to or near the target location. Examples of positioning the tissue piercer near the target location by expanding the multiple expandable arms on the distal end of the first catheter include moving, rotating, or twisting the expandable arms near the target location. For example, FIG. 10B shows that the expandable arms 1005 and 1010, once released from the sheath 1012, can be expanded, such as by moving outward from the central axis of the system, to secure the position of the tissue piercer 1008 near the target location 1006. In addition to the expandable arm 1010, there may be multiple expandable arms that engage the vessel wall at multiple positions. The multiple engagement positions with the vessel wall may refer to multiple positions longitudinally or circumferentially. For additional stability, the multiple expandable arms may engage the wall longitudinally or circumferentially.

[0063] Consistent with some disclosed embodiments, the method includes sliding a sheath to radially expand the plurality of expandable arms so that at least one of the plurality of expandable arms contacts at least a portion of a wall of the anatomical vessel. The sheath may be understood as previously described and illustrated. For example, FIG. 10 shows a sheath 1012 in the form of a tube. Sliding the sheath to radially expand the plurality of expandable arms so that at least one of the plurality of expandable arms contacts at least a portion of a wall of the anatomical vessel refers to moving or translating the sheath to expose primed arms, which may be formed, for example, from a shape-memory material. By sliding the sheath, the arms extend circularly or radially outward away from the first catheter or its central axis to contact one or more portions of the wall. Examples of sliding the sheath include moving the sheath up and down on the first catheter by manual control of the sheath or by an electronic controller configured to control the movement of the sheath. For example, the sheath 1012 may be slid from the position shown in Figure 10A to the position shown in Figure 10B by pulling the sheath 1012 downward, away from the first catheter 1014. In this example, the expandable arms 1010 and 1005 are no longer constrained by the surrounding presence of the sheath 1012, as shown in Figure 10B. Thus, the expandable arms 1005 and 1010 shown in Figure 10B expand radially outward to touch opposing portions of the wall 1004 of the anatomical vessel.

[0064] Consistent with some disclosed embodiments, the method includes sliding the sheath to radially collapse the multiple expandable arms within the sheath. Sliding the sheath to radially collapse the multiple expandable arms within the sheath refers to a relative axial sliding movement between the arms and the sheath such that the arms are radially compressed within the sheath, or moving the sheath to reduce the maximum distance, width, or span of the expandable arms from the central axis in an inward or radial direction. Examples of sliding the sheath to radially collapse the multiple expandable arms within the sheath include pushing the arms toward the first catheter or pushing the arms toward each other via pressure of the sheath surrounding the arms. For example, the expandable arms 1005 and 1010 of FIG. 10B may be radially collapsed into the configuration shown in FIG. 10A by sliding the sheath 1012 distally toward the expandable arms 1005 and 1010. In this example, sliding the sheath 1012 causes the extendable arms 1005 and 1010 to be forced distally toward each other and collapse radially.

[0065] Consistent with certain disclosed embodiments, forming a puncture at the target location includes forming a hole in the wall between the coronary sinus and the left atrium. Forming a hole in the wall between the coronary sinus and the left atrium includes cutting or creating an incision in the wall to generate an opening, perforation, or orifice in the wall. Examples of forming a hole in the wall between the coronary sinus and the left atrium include ablating tissue in the wall or cutting into the wall. For example, in FIG. 8B , a tissue puncturer may form a hole in the wall 808 between the coronary sinus and the left atrium by cutting a hole in the wall 808. The hole may extend through both the coronary sinus and the left atrium.

[0066] Consistent with certain disclosed embodiments, the tissue piercer comprises a hollow structure. A hollow structure refers to an object or component having an empty space or void within it. Examples of hollow structures include a tube, a hollow needle, or a perforated cylinder. For example, FIG. 1 illustrates an example of a tissue piercer 118, which may be shaped as a needle with an empty space within it. The hollow space may be sized to allow a guidewire to pass through. In this way, when the needle is withdrawn, the guidewire remains in place and may be used to deliver other structures over the wire.

[0067] Consistent with certain disclosed embodiments, the tissue piercer comprises a solid structure. A solid structure refers to an object or component that does not contain an internal void or empty space. Examples of solid structures include a flat sheet, a blade, a solid needle, or a pin. For example, FIG. 5 shows an example of a tissue piercer 502 that may be shaped as a blade with no internal empty space.

[0068] Consistent with some disclosed embodiments, the method includes retracting the flexible catheter to move the distal end of a first arm of the plurality of expandable arms away from the target penetration site. Retracting the flexible catheter to move the distal end of the first arm of the plurality of expandable arms away from the target penetration site refers to withdrawing or pulling the flexible catheter from the target penetration site. Examples of retracting the flexible catheter include pulling the flexible catheter by manual control of the flexible catheter or by an electronic controller configured to control movement of the flexible catheter. For example, the distal end of the expandable arm 818 in FIG. 8B may be moved away from the target penetration site by pulling the catheter 812 away from the wall 808, as shown in FIG. 8A.

[0069] Consistent with certain disclosed embodiments, the method includes exchanging the puncture device with a guidewire through the dilator. Exchanging the puncture device may be understood as previously described and illustrated to replace the puncture device with a guidewire. For example, FIG. 7 shows a puncture device 702 that may be exchanged with a guidewire 706. Exchanging the puncture device with a guidewire through the dilator refers to removing the puncture device and inserting a guidewire into or inside the dilator. Examples of exchanging the puncture device with a guidewire through the dilator include introducing a guidewire inside the dilator and designing the dilator with a guidewire configured to move up and down within it. For example, the dilator 306 of FIG. 3 may include a cavity through which the puncture device 304 can be withdrawn and a guidewire can be inserted.

[0070] Consistent with some disclosed embodiments, orientation markers are used to guide the axial and rotational orientation of any portion of the system or the entire system. The use of orientation markers to guide the axial and rotational orientation of any portion of the system or the entire system refers to the use of visual or tactile cues, symbols, or indicators to determine the position or alignment of a portion or system. Examples of orientation markers include radiopaque bands, directional arrows, color coding, length markings, numerical gradations, raised or textured surfaces, or side holes or ports. For example, orientation markers may include heavy metals such as platinum or gold configured to appear bright in medical imaging, such as x-rays or fluoroscopy, to aid in visualizing the position or alignment of a flexible catheter within the body.

[0071] The following provisions are also disclosed herein: Clause 1. An intraluminal puncture system, comprising: a first catheter configured to be delivered within an anatomical vessel, the first catheter having a flexible positioning arm extending from a distal end thereof, the flexible positioning arm configured to transition between a collapsed orientation and an expanded orientation; a second catheter disposed within the first catheter, the second catheter having an open distal end secured to the flexible positioning arms such that the second catheter faces a wall of the anatomical vessel when the flexible positioning arms are in an extended orientation; an elongate shaft extendable through the second catheter; and a tissue piercer located at the distal end of the elongate shaft, the tissue piercer configured to advance axially within the second catheter and operably connected to the open distal end of the second catheter. Clause 2. The intraluminal puncture system of clause 1, further comprising at least one flexible support arm movable from a folded orientation to an extended orientation to cooperate with the flexible positioning arm to fix the distal end opening of the second catheter against the wall of the blood vessel. Clause 3. The endoluminal puncture system of any preceding clause, further comprising at least two flexible support arms for cooperating with the flexible positioning arms to secure the open distal end of the second catheter against the wall of the blood vessel. Clause 4. The intraluminal puncture system of any of the preceding clauses, wherein the flexible positioning arm includes an orifice therein, and the open distal end of the second catheter is connected to the orifice. Clause 5. The endoluminal puncture system of any preceding clause, further comprising a sheath within which the first catheter is positioned, the sheath configured to hold the flexible positioning arm in a collapsed orientation for axial movement relative to the first catheter and to allow the flexible positioning arm to transition to an expanded orientation when the flexible positioning arm exits the sheath. Clause 6. The intraluminal puncture system of any preceding clause, wherein the second catheter includes a proximal end configured to enable control of the open distal end extending from the sheath. Clause 7. The intraluminal puncture system of any preceding clause, wherein the elongate shaft includes a proximal end extending from the second catheter and configured to enable control of the tissue puncture device. Clause 8. The intraluminal puncture system of any of the preceding clauses, wherein the tissue puncture device includes a sharp edge or sharp blade configured to puncture tissue. Clause 9. The endoluminal puncture system of any preceding clause, wherein the flexible positioning arm and the at least one flexible support arm are configured to fold and expand radially relative to a central axis of the system. Clause 10. The endoluminal puncture system of any preceding clause, further comprising at least one control device for radial and axial manipulation of each of the elongate shaft, the first catheter, and the second catheter. Clause 11. The endoluminal puncture system of any preceding clause, wherein the at least one control device further includes a lock configured to prevent radial or axial manipulation of at least one of the elongate shaft, the first catheter, and the second catheter. Clause 12. The endoluminal puncture system of any preceding clause, further comprising a dilator configured to dilate the opening in the vessel wall caused by the tissue puncture device. Clause 13. The intraluminal puncture system of any preceding clause, further comprising a hollow tube within the second catheter, the hollow tube configured to act as a placeholder during replacement of the puncture device with a guidewire. Clause 14. The intraluminal puncture system of any preceding clause, wherein the dilator is configured for delivery over an elongate shaft. Clause 15. The endoluminal puncture system of any preceding clause, wherein the at least one flexible support arm and the flexible positioning arm cooperate in their respective extended orientations to respectively engage the wall at different locations. Clause 16. The intraluminal puncture system of any of the preceding clauses, wherein the angle of the open distal end is adjustable between 0 and 180 degrees relative to a central axis of the system to enable tissue puncture at a selected angle between 0 and 150 degrees. Clause 17. The endoluminal puncture system of any of the preceding clauses, wherein the open distal end is adjustable between 0 degrees and 180 degrees relative to the elongate axis of the system by axial movement of the second catheter relative to the first catheter. Clause 18. The intraluminal puncture system of any of the preceding clauses, wherein the second catheter is configured to bend toward the wall to enable the tissue puncture device to puncture the wall at a right angle. Clause 19. The intraluminal puncture system of any preceding clause, wherein the at least one flexible support arm is configured to be positioned relative to the wall to enable the tissue puncture device to puncture the wall at a right angle. Clause 20. A method for puncturing the wall of an anatomical vessel, alone or in combination with any of the preceding clauses, comprising: advancing a flexible catheter having an open distal end within an anatomical vessel; manipulating the open distal end so that the open distal end faces a target location on a wall of an anatomical vessel; bracing the open distal end within the vessel to limit movement of the open distal end; and advancing a tissue piercer through the flexible catheter to pierce a wall of the anatomical vessel at the target location. Clause 21. The method of the preceding clause, wherein the step of manipulating the open distal end includes bending a flexible positioning arm to which the distal open end is connected. Clause 22. The method of any preceding clause, wherein the bracing step includes expanding a plurality of flexible braces to different locations on the vessel wall. Clause 23. The method of any of the preceding clauses, wherein the tissue lancing device includes a needle. Clause 24. The method of any of the preceding clauses, further comprising the step of dilating the opening in the wall of the anatomical vessel caused by the tissue piercer. Clause 25. The method of any of the preceding clauses, wherein the dilating step includes advancing a dilator over the tissue piercer. Clause 26. The method of any preceding clause, wherein the method further includes the step of positioning a tissue piercer near the target location by expanding a plurality of extendable arms at a distal end of the first catheter. Clause 27. The method of any of the preceding clauses, wherein the method further includes sliding the sheath to radially expand the plurality of expandable arms such that at least one of the plurality of expandable arms contacts at least a portion of a wall of the anatomical vessel. Clause 28. The method of any preceding clause, wherein the method further includes sliding the sheath to radially collapse the plurality of extendable arms within the sheath. Clause 29. The method of any of the preceding clauses, wherein the anatomical vessel includes the coronary sinus. Clause 30. The method of any of the preceding clauses, wherein the step of forming a puncture at the target location includes forming a hole in the wall between the coronary sinus and the left atrium. Clause 31. The method of any of the preceding clauses, wherein the tissue piercer comprises a hollow structure. Clause 32. The method of any of the preceding clauses, wherein the tissue piercer comprises a non-hollow structure. Clause 33. The method of any preceding clause, wherein the method further includes the step of retracting the flexible catheter to move a distal end of a first arm of the plurality of expandable arms away from the target penetration site. Clause 34. The method of any of the preceding clauses, wherein the manipulating step includes axial or radial manipulation of the flexible catheter. Clause 35. The method of any of the preceding clauses, wherein the manipulating step includes adjusting the angle of the open distal end. Clause 36. The method of any of the preceding clauses, wherein the manipulating step includes adjusting the angle of the flexible positioning arm. Clause 37. The method of any of the preceding clauses, wherein the operating step includes adjusting a distance of the open distal end from the wall. Clause 38. The method of any of the preceding clauses, wherein the operating step includes adjusting a distance of the flexible positioning arm from the wall. Clause 39. The method of any of the preceding clauses, further comprising the step of replacing the puncture device with a guidewire through the dilator. Clause 40. The method of any of the preceding clauses, wherein the orientation marker is used to guide the axial and rotational orientation of any part of the system or the entire system. Clause 41. An intraluminal puncture system, alone or in combination with any of the preceding clauses, comprising: a first catheter configured to be delivered within an anatomical vessel, the first catheter having a flexible positioning arm extending from a distal end thereof, the flexible positioning arm configured to transition between a collapsed orientation and an expanded orientation; a second catheter disposed within the first catheter, the second catheter having an open distal end secured to the flexible positioning arms such that the second catheter faces a wall of the anatomical vessel when the flexible positioning arms are in an extended orientation; an elongate shaft extendable through the second catheter; a tool located at the distal end of the elongate shaft, the tool configured to advance axially within the second catheter and operably connected to the open distal end of the second catheter. Clause 42. A system of any of the preceding clauses in which the tool includes a balloon. Clause 43. A system of any of the preceding clauses in which the tool includes an excision device. Clause 44. A system according to any of the preceding clauses, in which the tool comprises an endoscope. Clause 45. A system of any of the preceding clauses in which the tool includes a basket. Clause 46. A system of any of the preceding clauses in which the tool includes a snare. Clause 47. A system of any of the preceding clauses in which the tool includes a gripper. Clause 48. A system according to any of the preceding clauses, in which the tool includes forceps.

[0072] The disclosed embodiments, whether implemented as a system, device, and / or method, may include any one of the following itemized features, alone or in combination with one or more other itemized features. Intraluminal puncture system a first catheter having a flexible positioning arm extending from a distal end thereof; The first catheter is configured to be delivered within the anatomical vessel. The flexible positioning arm is configured to transition between a collapsed orientation and an extended orientation. A second catheter placed within the first catheter The second catheter has an open distal end secured to the positioning arm. When the flexible positioning arm is in the extended orientation, the open distal end faces the wall of the anatomical vessel. An elongated shaft that can extend through the second catheter A tissue piercer located at the distal end of an elongated shaft The tissue piercer is configured to be advanced axially within the second catheter. a tissue piercer operably connected to the open distal end of the second catheter; A tool located at the distal end of an elongated shaft The tool is configured to be advanced axially within the second catheter. The tool is operably connected to the open distal end of the second catheter. Tools include balloons Tools include ablation devices Tools include endoscopes Tool basket included Tools include snare The tool includes a gripper Tools include forceps At least one flexible support arm The at least one flexible support arm is movable from a collapsed orientation to an extended orientation. For cooperation with flexible positioning arms To fix the distal opening of the second catheter against the wall of the blood vessel. At least two flexible support arms at least two flexible support arms for cooperating with the flexible positioning arms; To secure the open distal end of the second catheter against the wall of the blood vessel. The flexible positioning arm includes an orifice therein. The open distal end of the second catheter is connected to the orifice. A sheath in which the first catheter is located The sheath is configured to move axially relative to the first catheter. The sheath is configured to hold the flexible positioning arm in a folded orientation. The sheath is configured to allow the flexible positioning arm to transition to an extended orientation when the flexible positioning arm exits the sheath. The second catheter includes a proximal end extending from the sheath. The proximal end is configured to allow control of the open distal end The elongate shaft includes a proximal end extending from the second catheter. The proximal end is configured to allow control of the tissue piercer. The tissue lancing device includes a sharp edge or blade configured to pierce tissue. The flexible positioning arm and the at least one flexible support arm are configured to fold and expand radially relative to a central axis of the system. at least one control device for radial and axial manipulation of each of the elongate shaft, the first catheter, and the second catheter; At least one control device further includes a lock The lock is configured to prevent radial or axial manipulation of at least one of the elongate shaft, the first catheter, and the second catheter. The dilator is configured to dilate the opening in the vessel wall caused by the tissue puncture device. A hollow tube within the second catheter The hollow tube is configured to act as a placeholder while replacing the puncture device with a guidewire. The dilator is configured to be delivered over an elongate shaft The at least one flexible support arm and the flexible positioning arm cooperate in their respective extended orientations to respectively engage the wall at different locations. The angle of the open distal end can be adjusted between 0 and 180 degrees relative to the central axis of the system. To allow tissue puncture at selected angles between 0 and 150 degrees The open distal end is adjustable between 0 and 180 degrees relative to the elongated axis of the system by axial movement of the second catheter relative to the first catheter The second catheter is configured to bend toward the wall to allow the tissue piercer to pierce the wall at a right angle. The at least one flexible support arm is configured to be positioned against the wall to allow the tissue piercer to pierce the wall at a right angle. A method for puncturing the wall of an anatomical vessel advancing a flexible catheter having an open distal end within the anatomical vessel; -Operating the open distal end The open distal end is positioned against the target location on the wall of the anatomical vessel. Bracing the open distal end within the vessel To limit the movement of the open distal end Advancing a tissue piercer through the flexible catheter To puncture the wall of an anatomical vessel at the target location The step of manipulating the open distal end includes bending a flexible positioning arm to which the distal open end is connected. The bracing step includes expanding a plurality of flexible braces against different locations on the vessel wall. The tissue lancing device includes a needle Dilating the opening in the wall of an anatomical vessel caused by a tissue puncture device The dilating step includes advancing a dilator over the tissue puncture. Positioning the tissue piercer near the target location. by extending a plurality of extendable arms on the distal end of the first catheter. Sliding the sheath to radially expand the plurality of expandable arms. At least one of the plurality of expandable arms comes into contact with at least a portion of a wall of an anatomical vessel. Sliding the sheath to radially collapse the plurality of extendable arms within the sheath. Anatomical vessels include the coronary sinus The step of forming a puncture at the target location includes forming a hole in the wall between the coronary sinus and the left atrium. The tissue puncture device includes a hollow structure The tissue puncture device includes a non-hollow structure Retracting the flexible catheter to move a distal end of a first arm of the plurality of extendable arms away from the target penetration site. The manipulating step includes axial or radial manipulation of the flexible catheter. The manipulating step includes adjusting the angle of the open distal end. The operating step includes adjusting an angle of the flexible positioning arm. The operating step includes adjusting a distance of the open distal end from the wall. The operating step includes adjusting a distance of the flexible positioning arm from the wall. - Replacing the puncture device with a guide wire through the dilator Orientation markers are used to guide the axial and rotational orientation of any part of the system or the entire system

[0073] Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the disclosed embodiments being indicated by the appended claims.

Claims

1. An intraluminal puncture system, comprising: a first catheter configured for delivery within an anatomical vessel, the first catheter having a flexible positioning arm extending from a distal end, the flexible positioning arm configured to transition between a collapsed orientation and an expanded orientation; a second catheter disposed within the first catheter, the second catheter having an open distal end secured to the flexible positioning arm such that the second catheter faces a wall of the anatomical vessel when the flexible positioning arm is in the expanded orientation; an elongate shaft extendable through the second catheter; a tissue piercer located at a distal end of the elongate shaft, the tissue piercer configured to advance axially within the second catheter and operably connected to the open distal end of the second catheter.

2. 10. The endoluminal puncture system of claim 1, further comprising at least one flexible support arm movable from a collapsed orientation to an expanded orientation to cooperate with the flexible positioning arm to secure the distal end opening of the second catheter against the wall of the blood vessel.

3. The endoluminal puncture system of claim 1 , further comprising at least two flexible support arms for cooperating with the flexible positioning arms to secure the open distal end of the second catheter against the wall of the blood vessel.

4. The endoluminal puncture system of claim 1 , wherein the flexible positioning arm includes an orifice therein, and the open distal end of the second catheter is connected to the orifice.

5. 3. The endoluminal puncture system of claim 1, further comprising a sheath within which the first catheter is positioned, the sheath configured to hold the flexible positioning arm in the folded orientation for axial movement relative to the first catheter and to allow the flexible positioning arm to transition to the expanded orientation when the flexible positioning arm exits the sheath.

6. The endoluminal puncture system of claim 5 , wherein the second catheter includes a proximal end extending from the sheath and configured to allow control of the open distal end.

7. The endoluminal puncture system of claim 1 , wherein the elongate shaft includes a proximal end extending from the second catheter and configured to allow control of the tissue piercer.

8. The endoluminal puncture system of claim 1 , wherein the tissue piercer includes a sharp edge or blade configured to pierce tissue.

9. The endoluminal puncture system of claim 2 , wherein the flexible positioning arm and the at least one flexible support arm are configured to fold and expand radially relative to a central axis of the system.

10. The endoluminal puncture system of claim 1 , further comprising at least one control device for radial and axial manipulation of each of the elongate shaft, the first catheter, and the second catheter.

11. 11. The endoluminal puncture system of claim 10, wherein the at least one control device further comprises a lock configured to prevent radial or axial manipulation of at least one of the elongate shaft, first catheter, and second catheter.

12. The endoluminal puncture system of claim 1 , further comprising a dilator configured to dilate the opening in the vessel wall caused by the tissue puncture device.

13. The endoluminal puncture system of claim 1 , further comprising a hollow tube within the second catheter, the hollow tube configured to act as a placeholder during replacement of the puncture device with a guidewire.

14. The endoluminal puncture system of claim 12 , wherein the dilator is configured to be delivered over the elongate shaft.

15. The endoluminal puncture system of claim 2 , wherein the at least one flexible support arm and the flexible positioning arm cooperate in their respective extended orientations to respectively engage the wall at different locations.

16. 10. The endoluminal puncture system of claim 1, wherein the angle of the open distal end is adjustable between 0 and 180 degrees relative to a central axis of the system to enable tissue puncture at a selected angle between 0 and 150 degrees.

17. 2. The endoluminal puncture system of claim 1, wherein the open distal end is adjustable between 0 and 180 degrees relative to an elongate axis of the system by axial movement of the second catheter relative to the first catheter.

18. 2. The endoluminal puncture system of claim 1, wherein the distal end of the second catheter is configured to bend toward the wall upon axial manipulation to enable the tissue piercer to pierce the wall at a right angle.

19. The endoluminal puncture system of claim 2 , wherein the at least one flexible support arm is configured to be positioned relative to the wall to allow the tissue piercer to pierce the wall at a right angle.

20. 1. A method for puncturing a wall of an anatomical vessel, comprising: advancing a flexible catheter having an open distal end within the anatomical vessel; manipulating the open distal end so that the open distal end faces a target location on the wall of the anatomical vessel; bracing the open distal end within the vessel to limit movement of the open distal end; and advancing a tissue piercer through the flexible catheter to pierce the wall of the anatomical vessel at the target location.

21. 21. The method of claim 20, wherein manipulating the open distal end comprises bending a flexible positioning arm to which the distal open end is connected.

22. 21. The method of claim 20, wherein the bracing step includes expanding multiple flexible braces to different locations on the vessel wall.

23. 21. The method of claim 20, wherein the tissue piercer comprises a needle.

24. 21. The method of claim 20, further comprising the step of dilating an opening in the wall of the anatomical vessel caused by the tissue piercer.

25. 25. The method of claim 24, wherein the dilating step comprises advancing a dilator over the tissue piercer.

26. 21. The method of claim 20, further comprising positioning the tissue piercer near the target location by expanding a plurality of expandable arms on a distal end of a first catheter.

27. 21. The method of claim 20, wherein the method further comprises sliding a sheath to radially expand the plurality of expandable arms such that at least one of the plurality of expandable arms contacts at least a portion of a wall of the anatomical vessel.

28. 28. The method of claim 27, further comprising sliding the sheath to radially collapse the plurality of extendable arms within the sheath.

29. 21. The method of claim 20, wherein the anatomical vessel comprises the coronary sinus.

30. 21. The method of claim 20, wherein forming a puncture at the target location comprises forming a hole in the wall between the coronary sinus and the left atrium.

31. 21. The method of claim 20, wherein the tissue piercer comprises a hollow structure.

32. 21. The method of claim 20, wherein the tissue piercer comprises a solid structure.

33. 21. The method of claim 20, further comprising retracting the flexible catheter to move the distal end of a first arm of the plurality of expandable arms away from the target penetration site.

34. 21. The method of claim 20, wherein the manipulating step comprises axial or radial manipulation of the flexible catheter.

35. 21. The method of claim 20, wherein the manipulating step includes adjusting the angle of the open distal end.

36. 22. The method of claim 21, wherein the manipulating step comprises adjusting an angle of the flexible positioning arm.

37. 21. The method of claim 20, wherein the manipulating step includes adjusting a distance of the open distal end from the wall.

38. 21. The method of claim 20, wherein the manipulating step comprises adjusting a distance of the flexible positioning arm from the wall.

39. 26. The method of claim 25, further comprising exchanging the piercer for a guidewire through the dilator.

40. The method of claim 20 , wherein orientation markers are used to guide the axial and rotational orientation of any part of the system or the entire system.

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