Transcatheter Needle System

Abstract

To provide a puncture needle.SOLUTION: The puncture needle can comprise a puncture tip configured to pierce tissue, and a distal portion comprising an anchor portion and a curved puncture portion. The curved puncture portion can comprise a first end associated with the puncture tip, and a second end coupled to the anchor portion, where the anchor portion comprises a portion distal to the curved puncture portion. A puncture needle system can comprise the puncture needle and a delivery catheter comprising a lumen, the puncture needle extending through the lumen. The delivery catheter can have a side outlet opening on a distal portion of the delivery catheter, the side outlet opening configured to allow extension therethrough of at least a portion of the curved puncture portion, where the anchor portion extends through a portion of the lumen distal to the side outlet opening.SELECTED DRAWING: Figure 8B

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 902,747, entitled "TRANSCATHETER PUNCTURE NEEDLE SYSTEM," filed September 19, 2019, the disclosure of which is expressly incorporated herein by reference in its entirety for all purposes.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of transcatheter puncture needles used in the delivery of medical implant devices and / or therapies. [Background technology]

[0003] Transcatheter delivery of a puncture needle to a target vessel, channel, chamber, and / or organ can be performed in a minimally invasive procedure to form an opening at the target tissue site. The opening can be formed so that a medical implant device and / or therapy can be provided to the target tissue site. For example, delivery of an implant device and / or therapy to the heart can be performed to treat elevated pressure in the left atrium. Summary of the Invention [Means for solving the problem]

[0004] Described herein are devices, systems, and methods relating to transcatheter needles that can be used in minimally invasive procedures to create openings at target tissue sites, including above the left atrial wall within the heart.

[0005] In some implementations, the puncture needle can include a puncture tip configured to puncture tissue and an elongated portion. The elongated portion can include a distal portion including: a curved puncture portion having a first end associated with the puncture tip and extending from the first end to a first bend, the first bend having a distally oriented first acute angle; a first elongated distal portion that meets the curved puncture portion at the first bend and extends from the first bend to a second bend, the second bend having a proximally oriented second acute angle; and a second elongated distal portion that meets the first and second bends at the second bend and extends proximally from the second bend. The second bend can be distal to the curved piercing portion.

[0006] In some embodiments, the first elongate distal portion, the second elongate distal portion, and the curved piercing portion lie in one plane. In some embodiments, the elongate portion is a single wire.

[0007] In some embodiments, the first elongate distal portion includes a first curved distal portion, the second elongate distal portion includes a second curved distal portion, and the first and second curved distal portions have the same orientation as the curved piercing portion. In some embodiments, the radius of curvature of the curved piercing portion is smaller than the respective radii of curvature of the first and second curved distal portions.

[0008] In some implementations, the puncture needle can include a puncturing tip configured to puncture tissue and an elongated portion including a distal portion, the distal portion including a curved elongated distal portion and a curved puncturing portion, the curved puncturing portion extending from the curved elongated distal portion to the puncturing tip. The curved elongated distal portion and the curved puncturing portion can have the same orientation. The distal end of the curved elongated distal portion can be distal to the curved puncturing portion.

[0009] In some embodiments, the radius of curvature of the curved elongate distal portion is greater than the radius of curvature of the curved piercing portion.

[0010] In some implementations, the puncture needle can include a puncture tip configured to puncture tissue and a distal portion. The distal portion can include an anchor portion and a curved puncture portion, the curved puncture portion including a first end associated with the puncture tip and a second end coupled to the anchor portion. The anchor portion can include a portion distal to the curved puncture portion.

[0011] In some embodiments, the curved piercing portion is proximally oriented and the piercing tip points proximally, hi some embodiments, the curved piercing portion is distally oriented and the piercing tip points distally.

[0012] In some embodiments, the curved piercing portion comprises a segment of a circle, hi some embodiments, the curved piercing portion comprises a semicircle.

[0013] In some embodiments, the distal portion includes a transverse cross-section having a rectangular shape, the transverse cross-section being taken along a plane perpendicular to the longitudinal axis of the puncture needle.

[0014] In some embodiments, the anchor portion is a curved anchor portion, and the curved anchor portion includes a portion distal to the curved puncture portion and a proximal portion coupled to a second end of the curved puncture portion. In some embodiments, the curved anchor portion and the curved puncture portion include the same orientation. In some embodiments, the radius of curvature of the curved puncture portion is smaller than the radius of curvature of the curved anchor portion. In some embodiments, the curved anchor portion includes a shape configured to match the curvature of the coronary sinus along its length.

[0015] In some embodiments, the anchor portion can include a first anchor portion including a first end and a second end, where the first end of the first anchor portion is connected to the curved puncture portion, and a second anchor portion including a first end connected to the second end of the first anchor portion and extending proximally from the first end of the second anchor portion. The first anchor portion and the second anchor portion can meet at a bend, where the bend is oriented proximally and distal to the curved puncture portion. In some embodiments, the bend includes an acute angle.

[0016] In some embodiments, the curved puncture portion, the first anchor portion, and the second anchor portion lie in one plane. In some embodiments, the first anchor portion is a first curved anchor portion, and the second anchor portion is a second curved anchor portion. In some embodiments, the curved puncture portion, the first curved anchor portion, and the second curved anchor portion comprise the same orientation. In some embodiments, the radius of curvature of the curved puncture portion is smaller than the respective radii of curvature of the first curved anchor portion and the second curved anchor portion. In some embodiments, the first curved anchor portion and the second curved anchor portion each comprise a shape configured to match the curvature along the length of the coronary sinus.

[0017] In some embodiments, the first anchor portion and the second anchor portion are each linear portions, in some embodiments, the curved puncture portion is proximally oriented, the curved puncture portion and a first end of the first anchor portion meet at a distally oriented first bend, and the first anchor portion and the second anchor portion meet at a proximally oriented second bend.

[0018] In some implementations, the puncture needle system can include a puncture needle and a delivery catheter. The puncture needle can include a puncture tip and a distal portion. The distal portion can include an anchor portion and a curved puncture portion, the curved puncture portion including a first end associated with the puncture tip and a second end coupled to the anchor portion, the anchor portion including a portion distal to the curved puncture portion. The delivery catheter can include a lumen, the puncture needle extending through the lumen, the delivery catheter including a side exit opening at the distal portion of the delivery catheter, the side exit opening configured to allow at least a portion of the curved puncture portion to extend therethrough, and the anchor portion extending through a distal portion of the lumen distal to the side exit opening.

[0019] In some embodiments, the distal portion of the lumen distal to the side exit opening comprises a transverse cross-section comprising a non-circular shape, the transverse cross-section being taken along a plane perpendicular to the longitudinal axis of the delivery catheter, hi some embodiments, the transverse cross-section of the distal portion of the lumen comprises the same shape as the transverse cross-section of the anchor portion.

[0020] In some embodiments, the system includes a medical implant guidewire sheath configured to slidably receive the medical implant guidewire, the medical implant guidewire sheath including a distal portion coupled to at least a portion of the curved piercing portion.

[0021] In some embodiments, the anchor portion is a curved anchor portion, the curved anchor portion including a portion distal to the curved piercing portion and a proximal portion coupled to a second end of the curved piercing portion.

[0022] In some embodiments, the anchor portion includes a first anchor portion including a first end and a second end, the first end of the first anchor portion being coupled to the curved puncture portion, and a second anchor portion including a first end coupled to the second end of the first anchor portion and extending proximally from the first end of the second anchor portion, the first anchor portion and the second anchor portion being capable of meeting at a bend, the bend being oriented proximally and distal to the curved puncture portion.

[0023] In some embodiments, the curved piercing portion, the first anchor portion, and the second anchor portion lie in one plane.

[0024] In some embodiments, the first anchor portion is a first curved anchor portion, the second anchor portion is a second curved anchor portion, and the curved piercing portion, the first curved anchor portion, and the second curved anchor portion comprise the same orientation.

[0025] In some embodiments, the first anchor portion and the second anchor portion are each linear portions.

[0026] In some embodiments, while the puncture needle is in a retracted state, the puncture tip is configured to be proximal to the side exit opening, and the anchor portion includes a portion that extends along the lumen beyond the side exit opening and through a portion of the lumen distal to the side exit opening.

[0027] In some embodiments, while the puncture needle is in the retracted state, the puncture tip is configured to be distal to the side exit opening, and the anchor portion extends distally through a portion of the lumen distal to the side exit opening.

[0028] In some implementations, a method for delivering a puncture needle can include advancing a puncture needle system into a blood vessel. The puncture needle system can include a puncture needle and a delivery catheter. The puncture needle can include a distal portion, the distal portion including an anchor portion and a curved puncture portion, the curved puncture portion including a first end associated with the puncture tip and a second end coupled to the anchor portion, the anchor portion including a portion distal to the curved puncture portion. The delivery catheter can include a puncture needle lumen, the puncture needle extending through the puncture needle lumen, and the delivery catheter including a side exit opening in a portion of the delivery catheter, the side exit opening configured to allow at least a portion of the curved puncture portion to extend therethrough. The method can include translating the puncture needle either distally or proximally relative to the delivery catheter to release at least a portion of the curved puncture portion through the side exit opening, and using the puncture tip extended through the side exit opening to puncture tissue at the target tissue site and form an opening at the target tissue site.

[0029] In some embodiments, the system further includes a medical implant guidewire sheath configured to slidably receive the medical implant guidewire, the medical implant guidewire sheath including a distal portion coupled to at least a portion of the curved piercing portion, and the method further includes advancing the medical implant guidewire through the medical implant guidewire sheath and through an opening associated with a distal end of the medical implant guidewire sheath and into an opening formed in the target tissue site.

[0030] In some embodiments, advancing the needle system into the blood vessel comprises advancing the needle system into the coronary sinus, hi some embodiments, perforating tissue at the target tissue site comprises perforating tissue above the left atrial wall.

[0031] For purposes of summarizing the disclosure, certain aspects, advantages, and novel features have been described herein. It should be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0032] Various embodiments are shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements. However, it should be understood that the use of like reference numerals in relation to multiple drawings does not necessarily imply similarity between the respective embodiments associated therewith. Moreover, it should be understood that features in the respective drawings are not necessarily drawn to scale, and that the depicted sizes are presented for purposes of illustrating aspects of the present invention. In general, certain of the depicted features may be relatively smaller than those shown in the drawings in some embodiments or configurations. [Brief explanation of the drawings]

[0033] [Figure 1] A cross-section of the human heart. [Figure 2] FIG. 2 is another cross-sectional view of the human heart. [Figure 3] 1 illustrates an example of a puncture needle according to one or more embodiments. [Figure 4] 10A-10C illustrate examples of needles including multiple rounded bends in a distal portion of the needle, according to one or more embodiments. [Figure 5] 1A-1C illustrate examples of puncture needles that include anchor portions that include a first curved anchor portion and a second curved anchor portion, according to one or more embodiments. [Figure 6] 1A-1C illustrate examples of puncture needles including anchor portions including a first anchor portion, a second anchor portion, a third anchor portion, and a fourth anchor portion, according to one or more embodiments. [Figure 7] 1A-1C illustrate examples of puncture needles including anchor portions including a first anchor portion, a second anchor portion, a third anchor portion, and a fourth anchor portion, according to one or more embodiments. [Figure 8A] FIG. 4 illustrates a needle system including the needle of FIG. 3 in a retracted state, according to one or more embodiments. [Figure 8B] 4 illustrates a needle system including the needle of FIG. 3 in a deployed state, according to one or more embodiments. [Figure 9] 1 illustrates a puncture needle system including a medical implant guidewire sheath, according to one or more embodiments. [Figure 10] 10A-10C illustrate examples of puncture needles including a curved anchor portion and a proximally oriented curved puncture portion, according to one or more embodiments. [Figure 11] 10A-10C illustrate examples of puncture needles including a curved anchor portion and a distally oriented curved puncture portion, according to one or more embodiments. [Figure 12] 10A-10C illustrate examples of puncture needles that include integrally formed curved anchor portions and curved puncture portions, according to one or more embodiments. [Figure 13A]11 illustrates a puncture needle system including the puncture needle described with reference to FIG. 10 in a retracted state, according to one or more embodiments. [Figure 13B] 11 illustrates a puncture needle system including the puncture needle described with reference to FIG. 10 in a deployed state, according to one or more embodiments. [Figure 14A] FIG. 1 illustrates another example of a needle system according to one or more embodiments. [Figure 14B] FIG. 1 illustrates another example of a needle system according to one or more embodiments. [Figure 14C] FIG. 1 illustrates another example of a needle system according to one or more embodiments. [Figure 14D] FIG. 1 illustrates another example of a needle system according to one or more embodiments. [Figure 15] 1 is a flow diagram of an example process for deploying a needle system to perforate tissue at a target tissue site, according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0034] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0035] The present disclosure relates to devices, systems, and methods for providing minimally invasive transcatheter delivery of a puncture needle to a target tissue site on a vessel, channel, chamber, and / or organ. The puncture needle as described herein can have a configuration that reduces or eliminates axial rotation of the puncture needle relative to a delivery catheter that receives it while the delivery catheter and puncture needle are advanced through a tortuous anatomical path to the target tissue site.

[0036] Although certain preferred embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, and to modifications and equivalents thereof. Accordingly, the scope of any claims that may arise herefrom is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular sequence disclosed. Various operations may be described sequentially as multiple separate operations, in a manner that may be helpful in understanding particular embodiments. However, the order of description should not be construed to imply that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0037] Certain standard anatomical location terms are used herein to refer to animal (and, i.e., human) anatomical structures for preferred embodiments. While certain spatially relative terms (e.g., "outer," "inner," "superior," "lower," "upper," "vertical," "horizontal," "top," "bottom," and similar terms) are used herein to describe the spatial relationship of one device / element or anatomical structure to another, it is understood that these terms are used herein for ease of description to describe the positional relationships between the elements / structures as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the elements / structures in use or operation in addition to the orientation shown in the drawings. For example, an element / structure described as "above" another element / structure may represent a position below or to the side of such other element / structure, and vice versa, with respect to the intended patient or alternative orientations of the element / structure.

[0038] In minimally invasive procedures, transcatheter delivery of a typical puncture needle into a blood vessel, channel, chamber, and / or organ can be challenging due to the difficulty of reliably controlling the axial orientation of the puncture needle. The puncture needle can undesirably rotate about its longitudinal axis when inserted through one or more bends in the anatomical pathway to reach a target site accessible from within the blood vessel, channel, chamber, and / or organ. The puncture needle can be received within a delivery catheter. A typical puncture needle can rotate axially relative to the delivery catheter while the delivery catheter and / or puncture needle are advanced to the target tissue site, thereby causing the puncture needle to become misaligned with the delivery catheter. Needle misalignment can hinder deployment of the puncture needle from the delivery catheter and / or shift the puncture needle's exit trajectory as it is extended from the delivery catheter, thereby preventing effective puncture of tissue at the target tissue site.

[0039] Transcatheter delivery of a needle into the coronary sinus may be performed in a procedure to create an opening in the left atrial wall separating the coronary sinus from the left atrium. The opening in the left atrial wall may be created for the delivery of a medical device implant and / or therapy to the left atrial wall. For example, a shunt device may be delivered into the opening in the left atrial wall to provide a blood flow conduit from the left atrium into the coronary sinus to treat elevated left atrial pressure. Typical transcatheter delivery of a needle into the coronary sinus may result in undesirable axial rotation of the needle within the delivery catheter lumen, thereby causing a significant offset in the needle's orientation. Incorrect orientation of the needle within the lumen may obstruct or prevent the desired opening on the left atrial wall, which may contribute to improper placement of the medical device implant and / or insufficient therapy delivery.

[0040] The present disclosure provides devices, systems, and methods for minimally invasive transcatheter delivery of a puncture needle to a target tissue site. Described herein is a puncture needle configured to maintain a desired axial orientation as the puncture needle is inserted through one or more bends in an anatomical pathway to the target site. In some embodiments, a puncture needle system can include a puncture needle and a delivery catheter configured to accept the puncture needle. The delivery catheter can include a puncture needle lumen configured to accept the puncture needle and a side exit opening on a distal portion configured to allow the puncture needle to extend therethrough to puncture tissue. The puncture needle can include one or more features configured to engage with a delivery catheter lumen wall to prevent or reduce axial rotation of the distal portion of the puncture needle relative to the delivery catheter. In some embodiments, the distal portion of the puncture needle can include an anchor portion and a curved puncture portion. The curved puncture portion can have a first end associated with the puncture tip configured to puncture tissue and a second end coupled to the anchor portion. The anchor portion can be configured to interact with a delivery catheter lumen wall and prevent or reduce axial rotation of the curved puncture portion. The anchor portion can include a portion extending distally of the curved puncture portion. In some embodiments, the portion of the anchor portion extending distally of the curved puncture portion can engage a portion of the delivery catheter lumen wall distal to the side exit opening and prevent or reduce axial rotation of the curved puncture portion.

[0041] In some embodiments, the anchor portion can include multiple portions that meet at one or more bends, such that the curved piercing portion and the anchor portion can include a zigzag shape. In some embodiments, the multiple portions of the anchor portion can each be linear or substantially linear. For example, the multiple portions of the anchor portion can be linear or substantially linear in a relaxed state. The linear or substantially linear portion can be flexible, such that a portion of the anchor portion can assume a curved configuration within the delivery catheter lumen as the delivery catheter bends during advancement through a tortuous anatomical path. In some embodiments, the anchor portion can be a single flexible portion, configured to assume a curved shape when positioned at or adjacent to the target tissue site. In some embodiments, the multiple portions of the anchor portion can each be curved, for example, including a preformed curve. In some embodiments, the anchor portion can be a single curved portion. For example, the anchor portion can be a preformed curved portion. The one or more pre-formed curved anchor portions are flexible and can facilitate advancement of the puncture needle through tortuous anatomical pathways and / or at or near the target tissue site.

[0042] In some embodiments, one or more of the puncture needles described herein can include a curved puncture portion and / or anchor portion, which has a transverse cross-section with a non-circular shape, for example, providing a reduced profile for the puncture needle. In some embodiments, the transverse cross-section can have a rectangular or substantially rectangular shape. Alternatively, in some embodiments, the transverse cross-section can have a rounded shape (including a circular or substantially circular shape). The transverse cross-section can be taken along a plane perpendicular or substantially perpendicular to the longitudinal axis of the puncture needle.

[0043] In some embodiments, the needles and / or needle systems described herein can be configured for positioning into the coronary sinus to access a target site on the left atrial wall. A needle such as those described herein can be used to create an opening in the left atrial wall so that a medical implant device, including a shunt device (e.g., an expandable shunt device), can be positioned on the left atrial wall. The shunt device can provide a blood flow pathway from the left atrium into the coronary sinus to relieve elevated left atrial pressure.

[0044] The needle system can be advanced from the right atrium into the coronary sinus via the coronary sinus ostium. The right atrium can be accessed via the superior vena cava (SVC) or the inferior vena cava (IVC). A transjugular or transsubclavian approach can be used to access the right atrium via the superior vena cava. Alternatively, a transfemoral approach can be used to position the needle system into the inferior vena cava and from there into the right atrium. To access the coronary sinus, the needle system can traverse one or more bends in the anatomical pathway. The bend or bends may tend to rotate the needle axially. For example, advancing the needle system from the right atrium into the coronary sinus via the coronary sinus ostium may involve one or more bends, which may result in a torsional force being exerted on the needle and tend to rotate it. The anchor portion can engage one or more portions of the delivery catheter lumen wall to reduce or eliminate axial rotation of the curved puncture portion, effectively decoupling the axial orientation of the curved puncture portion from any axial rotation of a portion of the puncture needle proximal to the curved puncture portion. The anchor portion can engage a portion of the delivery catheter lumen wall distal to the side exit opening such that the axial orientation of the curved puncture portion is unaffected or substantially unaffected by axial rotation of a more proximal portion of the puncture needle.

[0045] In some embodiments, one or more of the puncture needles described herein can include an anchor portion and a curved puncture portion that are integrally formed. In some embodiments, the anchor portion and the curved puncture portion can be integrally formed using one single elongated portion. For example, the single elongated portion can be shaped from a single piece of material (e.g., a single piece of metal material, a single piece of polymeric material). In some embodiments, the single piece of material can be divided to provide the anchor portion and the curved puncture portion. For example, the curved puncture portion can be carved and / or cut from the piece of material to separate the curved puncture portion from the remainder of the piece of material, which comprises the anchor portion. In some embodiments, forming the anchor portion and the curved puncture portion from a single piece of material can reduce or eliminate more prone-to-failure locations (e.g., locations where two pieces of material are joined together). In some embodiments, the anchor portion and the curved puncture portion can be formed using multiple separate pieces of material that are joined together (e.g., bonded, welded, glued).

[0046] Although the needle and / or needle system are described herein primarily as being used to access the heart, it will be understood that the use of the needle and / or needle system is not so limited. The needle and / or needle system may be used to access any number of blood vessels, channels, chambers, and / or organs, which involves advancing the needle and / or needle system through an anatomical passage having one or more bends that may tend to rotate the needle axially.

[0047] The term "associated" is used herein in accordance with its broad ordinary meaning. For example, when a first feature, element, component, device, or member is described as "associated" with a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically linked to, attached to, connected to, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly.

[0048] References herein to a "catheter" and / or "delivery catheter" may generally refer to or apply to any type of elongated tubular delivery device (e.g., including a delivery sheath and / or cannula) that includes an inner lumen configured to slidably receive an instrument, such as for positioning within the atrium or coronary sinus.

[0049] To aid in understanding the present disclosure, various features of heart 1 will be described with reference to FIG. 1 . Heart 1 includes four chambers: left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. A muscular wall (referred to as septum 10) separates left atrium 2 from right atrium 5 and also separates left ventricle 3 from right ventricle 4. Blood flow through heart 1 is controlled, at least in part, by four valves: mitral valve 6, aortic valve 7, tricuspid valve 8, and pulmonary valve 9. Mitral valve 6 separates left atrium 2 from left ventricle 3 and controls blood flow therebetween. Aortic valve 7 separates left ventricle 3 from aorta 12 and controls blood flow therebetween. Tricuspid valve 8 separates right atrium 5 from right ventricle 4 and controls blood flow therebetween. The pulmonary valve 9 separates the right ventricle 4 and the pulmonary artery 11 and controls blood flow between them.

[0050] In a healthy heart, cardiac valves open and close appropriately in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole) to at least partially control the flow of blood to each region and / or vessel of the heart. Deoxygenated blood arriving from the rest of the body typically flows into the right side of the heart for transport to the lungs, and oxygenated blood from the lungs typically flows into the left side of the heart for transport to the rest of the body. During ventricular diastole, deoxygenated blood arrives from the inferior vena cava 15 and superior vena cava 16 into the right atrium 5 and flows into the right ventricle 4, while oxygenated blood arrives from the pulmonary veins into the left atrium 2 and flows into the left ventricle 3. During ventricular systole, deoxygenated blood from the right ventricle 4 can flow into the pulmonary artery 11 for transport to the lungs (e.g., via the left pulmonary artery 14 and right pulmonary artery 13), and oxygenated blood can flow from the left ventricle 3 to the aorta 12 for transport to the rest of the body.

[0051] Several conditions can contribute to higher-than-normal pressure in the left atrium. Mitral valve dysfunction can contribute to elevated left atrial pressure. Diseases such as mitral valve regurgitation and / or stenosis can result in difficulty pumping blood from the left atrium to the left ventricle, contributing to elevated pressure in the left atrium. Valve stenosis can cause the valve to narrow or become blocked. Mitral valve stenosis can restrict blood flow from the left atrium to the left ventricle. Valve regurgitation occurs when the valve does not close properly. For example, regurgitation can occur due to improper coaptation of the valve leaflets. Mitral valve regurgitation can result in blood leaking back into the left atrium 2 from the left ventricle 3 when the left ventricle 3 contracts. Both the restricted flow of blood from the left atrium 2 into the left ventricle 3 and the blood leaking back into the left atrium 2 from the left ventricle 3 can contribute to elevated atrial pressure. Left ventricular dysfunction can also contribute to elevated left atrial pressure, which can lead to left atrial hypertrophy and symptoms such as shortness of breath during exercise, fatigue, chest pain, fainting, arrhythmia, and swelling of the legs and feet.

[0052] FIG. 2 is another view of the heart 1, showing the coronary sinus 18 around the left atrium 2. To alleviate elevated left atrial pressure, a conduit may be provided to allow blood flow from the left atrium 2 into a portion of the heart at a lower pressure (e.g., the coronary sinus 18). A conduit may be formed on the wall of the left atrium 2 adjacent to the coronary sinus 18 to allow blood flow from the left atrium 2 into the coronary sinus 18. The coronary sinus 18 receives blood from the coronary veins and drains into the right atrium 5. Blood diverted from the left atrium 2 into the coronary sinus 18 may then be delivered into the right atrium 5. A shunt device may be positioned at a location on the left atrial wall (e.g., a location accessible from the coronary sinus 18) to create a blood flow pathway from the left atrium 2 into the coronary sinus 18. Access into the coronary sinus 18 can involve navigating into the right atrium 5 and entering through the coronary sinus ostium 17 .

[0053] FIG. 3 is a perspective view of an example of a puncture needle 100. The puncture needle 100 can be received within a delivery catheter while the delivery catheter is advanced to a target tissue site. The distal portion 102 of the puncture needle 100 can include a curved puncture portion 120 and an anchor portion 170. For example, the puncture needle 100 can include an elongated portion 110, and the distal portion 112 of the elongated portion 110 can include the curved puncture portion 120 and the anchor portion 170. The puncture needle 100 can have a configuration that eliminates or reduces axial rotation of the curved puncture portion 120 within the delivery catheter as the delivery catheter is advanced through a tortuous anatomical path. The anchor portion 170 can be configured to engage one or more portions of the lumen wall of the delivery catheter to reduce or eliminate rotation of the curved puncture portion 120 relative to the delivery catheter. The anchor portion 170 can include a portion extending distally of the curved puncture portion 120. In some embodiments, the portion of the anchor portion 170 extending distally of the curved puncture portion 120 can engage a corresponding portion of the wall of the delivery catheter lumen to facilitate maintaining a desired axial orientation for the curved puncture portion 120. In some embodiments, both the anchor portion 170 and the curved puncture portion 120 can be configured to engage one or more portions of the wall of the delivery catheter lumen to reduce or eliminate rotation of the curved puncture portion 120. As described in further detail herein, while the puncture needle 100 is positioned within or substantially within the delivery catheter (e.g., while the puncture needle 100 is in a retracted state), the curved puncture portion 120 and the anchor portion 170 can engage a corresponding portion of the wall of the delivery catheter lumen to prevent or reduce axial rotation of the curved puncture portion 120.

[0054] The curved puncturing portion 120 can include a first end 122 associated with a puncturing tip 180. The puncturing tip 180 can be configured to puncture tissue at the target tissue site. The curved puncturing portion 120 can include a second end 124 coupled to the anchor portion 170. The radius of curvature of the curved puncturing portion 120 can be selected to facilitate tissue puncture and / or formation of a desired opening at the target tissue site. The curvature can facilitate insertion of the puncturing needle 100 into tissue at the target tissue site as the curved puncturing portion 120 extends from the delivery catheter. The curved puncturing portion 120 can include a preformed curvature configured to facilitate access to the target tissue site and to facilitate effective puncture of the target tissue site while the puncturing needle 100 is positioned within a vessel, channel, chamber, and / or organ. For example, in a relaxed state, the preformed curvature radius of the curved puncturing portion 120 can facilitate accessing and / or puncturing a target tissue site on the left atrial wall while the curved puncturing portion 120 is extended from a side exit opening of a delivery catheter positioned within the coronary sinus. The curved puncturing portion 120 can include a shape-memory material, allowing the curved puncturing portion 120 to assume a curved configuration after it is released from the delivery catheter lumen. In some embodiments, the curved puncturing portion 120 can include a circular segment. For example, the curved puncturing portion 120 can include a semicircular shape. With reference to FIG. 3 , the curved puncturing portion 120 can be proximally oriented. For example, an inner edge of the curved puncturing portion 120 can include at least a portion that is proximally oriented, such that at least a portion of a concave portion of the curved puncturing portion 120 is proximally oriented. In some embodiments, the piercing tip 180 can point proximally. In some embodiments, the piercing tip 180 can point laterally.

[0055] 3 , anchor portion 170 can include first anchor portion 130 and second anchor portion 140. First anchor portion 130 can include first end 132 and second end 134. First end 132 of first anchor portion 130 can be coupled to second end 124 of curved puncture portion 120. For example, first end 132 of first anchor portion 130 can meet second end 124 of curved puncture portion 120 at first bend 126. First bend 126 can be oriented distally or substantially distally. In some embodiments, at least a portion of the concave portion of first bend 126 is oriented distally. For example, first bend 126 can include an acute angle, where the acute angle is oriented distally or substantially distally.

[0056] The first anchor portion 130 and the second anchor portion 140 can meet at a second bend 136. The second anchor portion 140 can include a first end 142, which can be coupled to the second end 134 of the first anchor portion 130. The first end 142 of the second anchor portion 140 and the second end 134 of the first anchor portion 130 can meet at the second bend 136. The second bend 136 can be oriented proximally or substantially proximally. In some embodiments, at least a portion of the concave portion of the second bend 136 is oriented proximally. For example, the second bend 136 can include an acute angle, which can be oriented proximally or substantially proximally. In some embodiments, the first bend 126 and the second bend 136 can include opposing or substantially opposing orientations. In some embodiments, the first bend 126 and the second bend 136 can each include an acute angle, and the acute angles can include opposing or substantially opposing orientations. The second anchor portion 140 can extend proximally from the first end 142.

[0057] In some embodiments, first anchor portion 130 and second anchor portion 140 can each include a linear or substantially linear portion. As described herein, first bend 126 and second bend 136 can each include an acute angle and have opposing or substantially opposing orientations. Curved puncture portion 120 and anchor portion 170 can together include a zigzag shape. In some embodiments, first anchor portion 130 and second anchor portion 140 can each be a linear or substantially linear portion such that curved puncture portion 120 and anchor portion 170 can together include a “z” shape. In some embodiments, first anchor portion 130 and second anchor portion 140 can be flexible such that first anchor portion 130 and second anchor portion 140 can assume a curved configuration and conform to the curvature of a vessel, channel, chamber, and / or organ in which anchor portion 170 is positioned. In some embodiments, the flexibility of first anchor portion 130 and second anchor portion 140 can facilitate advancement of needle 100 through tortuous anatomical pathways.

[0058] In some embodiments, the curved puncture portion 120 and the anchor portion 170 can lie in the same plane and / or parallel planes. The curved puncture portion 120 and the anchor portion 170 can lie flat or substantially flat when laid on their sides. For example, the curved puncture portion 120, the first anchor portion 130, and the second anchor portion 140 can all extend along a line contained within the same plane. In some embodiments, the curved puncture portion 120, the first anchor portion 130, the second anchor portion 140, and the puncture tip 180 can all lie in the same plane. In some embodiments, the curved puncture portion 120 and the anchor portion 170 can include corresponding portions in the same plane. For example, each portion of the curved puncture portion 120, the first anchor portion 130, and the second anchor portion 140 can extend along a line contained in the same plane, such that the curved puncture portion 120, the first anchor portion 130, and the second anchor portion 140 each include portions that extend along lines contained in parallel planes.

[0059] In some embodiments, the curved piercing portion 120 can have a transverse cross-section that includes a rounded shape (including a circular or substantially circular shape). Alternatively, the transverse cross-section can include a non-circular shape, including a polygonal shape (e.g., a rectangular or substantially rectangular shape, etc.). The non-circular cross-sectional shape can provide a reduced profile for the piercing needle 100. The transverse cross-section of the curved piercing portion 120 can be taken along a plane that is perpendicular or substantially perpendicular to the concave surface of the curvature. In some embodiments, the anchor portion 170 can have a transverse cross-section that includes a rounded shape (including a circular shape). Alternatively, the transverse cross-section can include a non-circular shape, including a polygonal shape (e.g., a rectangular or substantially rectangular shape, etc.), for example, to provide a reduced profile for the piercing needle 100. In some embodiments, a transverse cross-section of a portion of anchor portion 170 can be taken along a plane perpendicular or substantially perpendicular to the longitudinal axis of puncture needle 100 and / or to the longitudinal axis of a portion of anchor portion 170.

[0060] In some embodiments, the curved piercing portion 120 and the anchor portion 170 may be integrally formed. In some embodiments, the curved piercing portion 120 and the anchor portion 170 can be part of a single elongated portion. For example, the distal portion 112 of the elongated portion 110 can include the curved piercing portion 120, a first anchor portion 130, and a second anchor portion 140. The first anchor portion 130 can be the first elongated distal portion. The second anchor portion 140 can be the second elongated distal portion. As described herein, the curved piercing portion 120 can have a piercing tip 180 associated with the first end 122. The curved piercing portion 120 can extend from the first end 122 to a first bend 126. The first bend 126 can have a distally oriented first acute angle. The first elongated distal portion (or first anchor portion 130) can merge with the curved puncture portion 120 at a first bend 126. The first elongated distal portion can extend from the first bend 126 to a second bend 136. The second bend 136 can have a proximally oriented second acute angle. The first elongated distal portion can merge with a second elongated distal portion (or second anchor portion 140) at the second bend 136. The second elongated distal portion can extend proximally from the second bend 136. The second bend 136 can be distal to the curved puncture portion 120.

[0061] In some embodiments, the first bend 126 and the second bend 136 can each include a sharp and / or pointed bend. In some embodiments, the sharp and / or pointed bend can facilitate a reduced profile for the distal portion 102 of the puncture needle 100.

[0062] As described herein, anchor portion 170 can include at least a portion distal to curved puncture portion 120. A portion of first anchor portion 130 and a portion of second anchor portion 140 can be distal to curved puncture portion 120. For example, second bend 136 can be distal to curved puncture portion 120. In some embodiments, the portion of anchor portion 170 distal to curved puncture portion 120 can engage one or more portions of a delivery catheter lumen wall to help maintain a desired orientation of curved puncture portion 120. Puncture needle 100 can be pre-loaded into the delivery catheter lumen, for example, with curved puncture portion 120 and anchor portion 170 positioned proximate or adjacent to a side exit opening configured to allow extension of puncture needle 100 therethrough.

[0063] As described in further detail herein, the anchor portion 170 can include a portion configured to be received within a portion of the delivery catheter lumen distal to the side exit opening while the puncture needle 100 is in both the retracted and deployed states. For example, engaging and / or interacting the anchor portion 170 with a portion of the lumen wall distal to the side exit opening, rather than with any portion of the lumen wall proximal to the side exit opening, can help stabilize the axial orientation of the anchor portion 170, thereby stabilizing the axial orientation of the curved puncture portion 120. The desired axial orientation of the curved puncture portion 120 can be maintained or substantially maintained despite torsional forces exerted on the puncture needle 100 and / or any rotation of the proximal portion of the puncture needle 100 while the delivery catheter is advanced through a tortuous anatomical path. Engaging the anchor portion 170 with a portion of the delivery catheter lumen wall distal to the side exit opening can decouple any axial rotation of the proximal portion of the puncture needle 100 from the curved puncture portion 120, allowing the curved puncture portion 120 to remain aligned relative to the delivery catheter. In some embodiments, the curved puncture portion 120 can exhibit no or reduced rotation about the longitudinal axis of the puncture needle 100 while the puncture needle 100 is positioned within the delivery catheter lumen and while the delivery catheter is advanced through a tortuous anatomical path to a target tissue site.

[0064] In some embodiments, both the curved puncture portion 120 and the anchor portion 170 can engage corresponding portions of the delivery catheter lumen wall, preventing or reducing axial rotation of the curved puncture portion 120. For example, bends 126, 136 in the distal portion 102 can cause the curved puncture portion 120 and the anchor portion 170 to have a tendency to extend radially. For example, the curved puncture portion 120 and the anchor portion 170 can be spring-loaded. The tendency to extend radially can increase contact between the puncture needle 100 and the lumen wall of the delivery catheter. The increased contact between the puncture needle 100 and the lumen wall can help secure the position and / or orientation of the curved puncture portion 120 and reduce or prevent rotation of the curved puncture portion 120. In some embodiments, the tendency of the anchor portion 170 and the curved piercing portion 120 to extend radially can facilitate the extension of the curved piercing portion 120 through the side exit opening when the piercing needle 100 is deployed.

[0065] 4 shows an example of a puncture needle 200. A distal portion 202 of the puncture needle 200 can include a plurality of bends, each of which can have a rounded configuration. The distal portion 202 of the puncture needle 200 can include a curved puncture portion 220 and an anchor portion 270. The anchor portion 270 can include at least a portion extending distally of the curved puncture portion 220. In some embodiments, the puncture needle 200 can include an elongated portion 210, and a distal portion 212 of the elongated portion 210 can include the curved puncture portion 220 and the anchor portion 270.

[0066] 4, the curved piercing portion 220 can include a first end 222 associated with the piercing tip 280 and a second end 224 coupled to the anchor portion 270. The curved piercing portion 220 can include one or more features of the curved piercing portion 120 described with reference to FIG. 3. For example, the curved piercing portion 220 can include a circular segment (e.g., semicircular, etc.). In some embodiments, the curved piercing portion 220 can be oriented proximally. In some embodiments, the piercing tip 280 can point proximally. In some embodiments, the piercing tip 280 can point laterally.

[0067] The anchor portion 270 can include a first anchor portion 230 including a first end 232 and a second end 234, and a second anchor portion 240 including a first end 242. The first end 232 of the first anchor portion 230 can be coupled to the second end 224 of the curved puncture portion 220. For example, the first end 232 of the first anchor portion 230 can meet the second end 224 of the curved puncture portion 220 at a first bend 226. As shown in FIG. 4 , the first bend 226 can be oriented distally or substantially distally. For example, the concave portion of the first bend 226 can include at least a portion that is oriented distally or substantially distally. The first anchor portion 230 and the second anchor portion 240 can meet at the second bend 236. The first end 242 of the second anchor portion 240 may be coupled to the second end 234 of the first anchor portion 230. The first end 242 of the second anchor portion 240 and the second end 234 of the first anchor portion 230 may meet at a second bend 236. In some embodiments, the first bend 226 and the second bend 236 may include opposing or substantially opposing orientations. The second bend 236 may be oriented proximally or substantially proximally. For example, the concave portion of the second bend 236 may include at least a portion that is oriented proximally or substantially proximally. The second anchor portion 240 may extend proximally from the second bend 236.

[0068] In some embodiments, one or both of the first bend 226 and the second bend 236 can be rounded (e.g., include an arcuate shape). One or both of the first bend 226 and the second bend 236 can include a segment of a circle or an ellipse. In some embodiments, both the first bend 226 and the second bend 236 can be rounded (e.g., include a segment of a circle). In some embodiments, while in a relaxed state (e.g., when the puncture needle 200 is not in the delivery catheter lumen), the first anchor portion 230 and the second anchor portion 240 can be parallel or substantially parallel to each other. In some embodiments, the second bend 236 can include a semicircular shape. In some embodiments, the first bend 226 can include a semicircular shape. In some embodiments, the first anchor portion 230 and the second anchor portion 240 are not parallel to each other. In some embodiments, the second bend 236 can include an acute angle. The acute angle can be oriented proximally or substantially proximally, for example, the concave portion of the second bend 236 can be oriented proximally or substantially proximally.

[0069] The first bend 226 and the second bend 236 can each be sized so that opposing portions of the first bend 226 and the second bend 236 can contact opposing portions of the delivery catheter lumen wall. In some embodiments, the contact between the bends 226, 236 and the delivery catheter lumen wall can reduce or prevent axial rotation of the distal portion 202 of the puncture needle 200, thereby maintaining a desired orientation of the curved puncture portion 220.

[0070] In some embodiments, engagement of anchor portion 270 and the delivery catheter lumen wall can prevent or reduce axial rotation of curved puncture portion 220. A portion of anchor portion 270 distal to curved puncture portion 220 can be received within a portion of the delivery catheter lumen distal to the side exit opening of the delivery catheter while puncture needle 200 is in both the retracted and deployed states. A portion of first anchor portion 230 and a portion of second anchor portion 240 can be distal to curved puncture portion 220. For example, second bend 236 can be distal to curved puncture portion 220. In some embodiments, a portion of anchor portion 270 distal to curved puncture portion 220 can engage one or more portions of the delivery catheter lumen wall distal to the side exit opening to facilitate maintaining a desired orientation of curved puncture portion 220. In some embodiments, both the curved puncture portion 220 and the anchor portion 270 can engage with corresponding portions of the delivery catheter lumen wall to prevent or reduce axial rotation of the curved puncture portion 220.

[0071] The puncture needle 200 may include one or more other features of the puncture needle 100 described with reference to FIG. 3 . For example, the first anchor portion 230 and the second anchor portion 240 may each include a linear or substantially linear portion. The first anchor portion 230 and the second anchor portion 240 may each be a linear or substantially linear portion. In some embodiments, the curved puncture portion 220 and the anchor portion 270 may together form a zigzag shape (e.g., including a “z” shape). In some embodiments, the first anchor portion 230 and the second anchor portion 240 may be flexible, allowing the anchor portions 230, 240 to assume a curved configuration and conform to the curvature of the vessel, channel, chamber, and / or organ in which the anchor portion 270 is positioned. The flexibility of the first anchor portion 230 and the second anchor portion 240 may facilitate the advancement of the puncture needle 200 through tortuous anatomical pathways.

[0072] In some embodiments, the curved puncture portion 220 and the anchor portion 270 can be in the same plane and / or parallel planes, e.g., extending along a line in the same plane and / or parallel planes. In some embodiments, the curved puncture portion 220, the first anchor portion 230, the second anchor portion 240, the first bend 226, the second bend 236, and the puncture tip 280 can all be in the same plane. The curved puncture portion 220 and the anchor portion 270 can lie flat or substantially flat when laid on their side. In some embodiments, the curved puncture portion 220 and the anchor portion 270 can include counterparts in the same plane. For example, each portion of the piercing tip 280, the curved piercing portion 220, the first anchor portion 230, the first bend 226, the second anchor portion 240, and the second bend 236 can extend along a line contained in the same plane, such that the piercing tip 280, the curved piercing portion 220, the first anchor portion 230, the first bend 226, the second anchor portion 240, and the second bend 236 each include portions that extend along lines contained in parallel planes.

[0073] In some embodiments, the curved puncture portion 220 and the anchor portion 270 may be integrally formed. In some embodiments, the curved puncture portion 220 and the anchor portion 270 can be part of a single elongate portion. For example, the distal portion 212 of the elongate portion 210 can include the curved puncture portion 220, the first bend 226, the first anchor portion 230, the second bend 236, and the second anchor portion 240. The transverse cross-sections of the curved puncture portion 220, the first bend 226, the first anchor portion 230, the second bend 236, and the second anchor portion 240 can include transverse cross-sections that include rounded shapes (including circular shapes). Alternatively, the transverse cross-sections can include non-circular shapes, including polygonal shapes (e.g., rectangular shapes, etc.). In some embodiments, transverse cross sections of curved puncture portion 220, first bend 226, and second bend 236 can be taken along a plane perpendicular or substantially perpendicular to the concavity of their respective concavities. In some embodiments, transverse cross sections of first anchor portion 230 and second anchor portion 240 can be taken along a plane perpendicular or substantially perpendicular to the longitudinal axis of anchor portion 270 and / or the respective portions of puncture needle 200.

[0074] 5 shows an example of a puncture needle 300, which includes an anchor portion 370 including a first curved anchor portion 330 and a second curved anchor portion 340. The first curved anchor portion 330 and the second curved anchor portion 340 may each include a preformed curvature. The distal portion 302 of the puncture needle 300 may include a curved puncture portion 320 and the anchor portion 370. For example, the elongated portion 310 of the puncture needle 300 may include a distal portion 312, which may include the curved puncture portion 320 and the anchor portion 370.

[0075] The curved piercing portion 320 can include one or more features of the curved piercing portion 120 described with reference to FIG. 3. The curved piercing portion 320 can include a first end 322 associated with the piercing tip 380 and a second end 324 coupled to the anchor portion 370. The curved piercing portion 320 can include a circular segment (e.g., semicircular, etc.). In some embodiments, the curved piercing portion 320 can be oriented proximally. In some embodiments, the piercing tip 380 can point proximally. In some embodiments, the piercing tip 380 can point laterally.

[0076] The first curved anchor portion 330 and the second curved anchor portion 340 can include the same orientation. In some embodiments, the first curved anchor portion 330 and the second curved anchor portion 340 can include the same orientation as the curved puncture portion 320. For example, the corresponding concave portions of the first curved anchor portion 330 and the second curved anchor portion 340 can include at least a portion that is oriented proximally or substantially proximally. The respective radii of curvature of the first curved anchor portion 330 and the second curved anchor portion 340 can be selected based at least on the shape of the desired vessel, channel, chamber, and / or organ into which the puncture needle 300 will be advanced to access the target tissue site. For example, the radii of curvature of the first curved anchor portion 330 and the second curved anchor portion 340 can be selected based on the radius of curvature of a portion of the coronary sinus into which the anchor portion 370 will be advanced. Anchor portion 370 can be shaped to follow the length of the curvature of the coronary sinus. In some embodiments, the radius of curvature for each of first curved anchor portion 330 and second curved anchor portion 340 can be greater than that of curved puncture portion 320. For example, the degree of curvature of curved puncture portion 320 can be greater than that of curved anchor portions 330, 340, respectively.

[0077] The curved puncture portion 320 can be coupled to a first curved anchor portion 330 at a first bend 326. A first end 332 of the first anchor portion 330 can meet a second end 324 of the curved puncture portion 320 at the first bend 326. The first bend 326 can be oriented distally or substantially distally. The first curved anchor portion 330 can be coupled to a second curved anchor portion 340 at a second bend 336. A first end 342 of the second anchor portion 340 can meet a second end 334 of the first anchor portion 330 at the second bend 336. In some embodiments, the first bend 326 and the second bend 336 can include opposing or substantially opposing orientations. The second bend 336 can be oriented proximally or substantially proximally. In some embodiments, the first bend 326 can include an acute angle, where the acute angle is oriented distally or substantially distally. In some embodiments, the second bend 336 can include an acute angle, where the acute angle can be oriented proximally or substantially proximally. The second anchor portion 340 can extend proximally from the second bend 336. In some embodiments, the first bend 326 and the second bend 336 can each include an acute angle, such that the curved piercing portion 320 and the anchor portion 370 can include a zigzag shape.

[0078] A portion of anchor portion 370 can be distal to curved puncture portion 320. For example, a portion of first anchor portion 330 and a portion of second anchor portion 340 can be distal to curved puncture portion 320. Second bend 336 can be distal to curved puncture portion 320. In some embodiments, a portion of anchor portion 370 distal to curved puncture portion 320 can engage a delivery catheter lumen wall distal to the side exit opening to prevent or reduce axial rotation of curved puncture portion 320. In some embodiments, both curved puncture portion 320 and anchor portion 370 can engage corresponding portions of the delivery catheter lumen wall to prevent or reduce axial rotation of curved puncture portion 320.

[0079] In some embodiments, the transverse cross-section of the curved puncture portion 320 and / or anchor portion 370 can be non-circular. The transverse cross-section can be taken along a plane perpendicular or substantially perpendicular to the concave surface of the curved puncture portion 320 and / or the respective portions of the anchor portion 370. The transverse cross-section can be selected to reduce the profile of the puncture needle 300. In some embodiments, the transverse cross-section can include a polygonal shape (e.g., a rectangular or substantially rectangular shape, etc.). In some embodiments, as described in further detail herein, the transverse cross-section of the anchor portion 370 can be selected to correspond to the transverse cross-section of a portion of the delivery catheter lumen distal to the side exit opening, which can facilitate engagement of the anchor portion 370 with the lumen wall. Improved engagement between the anchor portion 370 and the lumen wall can facilitate maintaining a desired orientation of the curved puncture portion 320. The concave surface of the curved piercing portion 320 and / or anchor portion 370 can be generally perpendicular to the long flat surfaces of its rectangular cross-sectional form, as in the diagram of Figure 5. Alternatively, the transverse cross-section of the curved piercing portion 320 and / or anchor portion 370 can include a rounded shape (e.g., a circular shape, etc.).

[0080] In some embodiments, the curved puncture portion 320 and the anchor portion 370 can be in the same plane and / or parallel planes, e.g., extending along a line in the same plane and / or parallel planes. In some embodiments, the curved puncture portion 320, the first anchor portion 330, the second anchor portion 340, and the puncture tip 380 can all be in the same plane. The curved puncture portion 320 and the anchor portion 370 can lie flat or substantially flat when laid on their side. In some embodiments, the curved puncture portion 320 and the anchor portion 370 can include counterparts in the same plane. For example, each portion of the curved piercing portion 320, the first anchor portion 330, the second anchor portion 340, and the piercing tip 380 can extend along a line contained in the same plane, such that the curved piercing portion 320, the first anchor portion 330, the second anchor portion 340, and the piercing tip 380 each include portions extending along lines contained in parallel planes. In some embodiments, the curved piercing portion 320 and the anchor portion 370 can be integrally formed, e.g., part of a single elongated portion. For example, the distal portion 312 of the elongated portion 310 can include the curved piercing portion 320, the first anchor portion 330, and the second anchor portion 340. The first anchor portion 330 can be a first curved distal portion, and the second anchor portion 340 can be a second curved distal portion.

[0081] 6 shows an example of a puncture needle 400, which includes an anchor portion 470 including a first anchor portion 430, a second anchor portion 440, a third anchor portion 450, and a fourth anchor portion 460. A distal portion 402 of the puncture needle 400 (e.g., the distal portion 412 of the elongated portion 410 of the puncture needle 400) can include the anchor portion 470. The anchor portion 470 can be coupled to a curved puncture portion 420. The curved puncture portion 420 can merge with the first anchor portion 430 at a first bend 426. For example, the first end 432 of the first anchor portion 430 can be coupled to the second end 424 of the curved puncture portion 420 at the first bend 426. The first bend 426 can be oriented distally or substantially distally. The first anchor portion 430 can merge with the second anchor portion 440 at a second bend 436. The second end 434 of the first anchor portion 430 can be coupled to the first end 442 of the second anchor portion 440 at the second bend 436. The second bend 436 can be oriented proximally or substantially proximally. The second anchor portion 440 can merge with the third anchor portion 450 at a third bend 446. For example, the second end 444 of the second curved anchor portion 440 can be coupled to the first end 452 of the third curved anchor portion 450 at the third bend 446. The third bend 446 can be oriented distally or substantially distally. The third anchor portion 450 can meet with the fourth anchor portion 460 at a fourth bend 456. The second end 454 of the third curved anchor portion 450 can be coupled to the first end 462 of the fourth anchor portion 460 at the fourth bend 456. In some embodiments, the fourth bend 456 can be oriented proximally or substantially proximally. The fourth anchor portion 460 can extend proximally from the fourth bend 456.

[0082] In some embodiments, each of the first bend 426, the second bend 436, the third bend 446, and the fourth bend 456 can include an acute angle. In some embodiments, adjacent bends can have opposite or substantially opposite orientations. For example, the first bend 426 can include an acute angle that is distally or substantially distally oriented. The second bend 436 can include an acute angle that is proximally or substantially proximally oriented. The third bend 446 can include an acute angle that is distally or substantially distally oriented. The fourth bend 456 can include an acute angle that is proximally or substantially proximally oriented. In some embodiments, each of the first anchor portion 430, the second anchor portion 440, the third anchor portion 450, and the fourth anchor portion 460 can include a linear or substantially linear portion. For example, each of first anchor portion 430, second anchor portion 440, third anchor portion 450, and fourth anchor portion 460 can be linear or substantially linear, with anchor portion 470 including a zigzag shape. In some embodiments, first anchor portion 430, second anchor portion 440, third anchor portion 450, and fourth anchor portion 460 can be flexible, allowing anchor portions 430, 440, 450, 460 to assume a curved configuration and conform to the curvature of a vessel, channel, chamber, and / or organ in which anchor portion 470 is positioned. Alternatively, in some embodiments, each of anchor portions 430, 440, 450, 460 can include a preformed curvature and conform to the curvature of a vessel, channel, chamber, and / or organ. In some embodiments, anchor portions 430, 440, 450, 460 can have a curved configuration and / or a pre-formed curve to facilitate advancement of needle 400 through tortuous anatomical pathways.

[0083] A portion of anchor portion 470 can be distal to curved puncture portion 420. For example, at least a portion of each of first anchor portion 430, second anchor portion 440, third anchor portion 450, and fourth anchor portion 460 can be distal to curved puncture portion 420. Second bend 436 and fourth bend 456 can be distal to curved puncture portion 420. A portion of anchor portion 470 distal to curved puncture portion 420 can engage with a delivery catheter lumen wall distal to the side exit opening. In some embodiments, both curved puncture portion 420 and anchor portion 470 can engage with corresponding portions of the delivery catheter lumen wall to prevent or reduce axial rotation of curved puncture portion 420.

[0084] 6 shows the second bend 436 distal to the fourth bend 456. In some embodiments, the second bend 436 can be proximal to the fourth bend 456. In some embodiments, having one of the second bend 436 or the fourth bend 456 distal to the other can facilitate improved engagement with the delivery catheter lumen wall distal to the side exit opening while maintaining a reduced distal profile for the puncture needle 400. In some embodiments, the second bend 436 and the fourth bend 456 can be in similar or the same distal location.

[0085] The curved piercing portion 420 may include one or more features of the curved piercing portion 120 described with reference to FIG. 3 . The curved piercing portion 420 may include a first end 422 associated with a piercing tip 480. The second end 424 may be coupled to the anchor portion 470. In some embodiments, the curved piercing portion 420 may include a circular segment (e.g., including a semicircular shape). The curved piercing portion 420 may be oriented proximally or substantially proximally. In some embodiments, the piercing tip 480 may point proximally. In some embodiments, the piercing tip 480 may point laterally. In some embodiments, the curved piercing portion 420 and the anchor portion 470 may be integrally formed, e.g., part of a single elongated portion.

[0086] FIG. 7 shows an example of a puncture needle 500, which includes a curved puncture portion 520 that is oriented distally or substantially distally. The distal portion 502 of the puncture needle 500 can include the curved puncture portion 520 and an anchor portion 570. The anchor portion 570 can be coupled to the curved puncture portion 520. For example, the distal portion 512 of the elongated portion 510 of the puncture needle 500 can include the anchor portion 570 and the curved puncture portion 520. The concave portion of the curved puncture portion 520 can include at least a portion that is oriented distally or substantially distally. In some embodiments, the puncture tip 580 can point distally. In some embodiments, the puncture tip 580 can point laterally. The curved puncture portion 520 can include one or more other features of the curved puncture portion 120 described with reference to FIG. 3. For example, the curved piercing portion 520 can include a first end 522 associated with the piercing tip 580 and a second end 524 coupled to the anchor portion 570. In some embodiments, the curved piercing portion 520 can include a circular segment (e.g., including a semicircular shape).

[0087] The puncture needle 500 can include one or more other features of the puncture needle 400 described with reference to FIG. 6 . In some embodiments, the puncture needle 500 can include other features of the puncture needle 400. For example, the anchor portion 570 can include a first anchor portion 530, a second anchor portion 540, a third anchor portion 550, and a fourth anchor portion 560. The first end 532 of the first anchor portion 530 can be coupled to the second end 524 of the curved puncture portion 520. The second end 534 of the first anchor portion 530 can be coupled to the first end 542 of the second anchor portion 540 at a first bend 536. The first bend 536 can be oriented proximally or substantially proximally. The second end 544 of the second curved anchor portion 540 can be coupled to a first end 552 of a third curved anchor portion 550 at a second bend 546. The second bend 546 can be oriented distally or substantially distally. The second end 554 of the third curved anchor portion 550 can be coupled to a first end 562 of a fourth anchor portion 560 at a third bend 556. The third bend 556 can be oriented proximally or substantially proximally. The fourth anchor portion 560 can extend proximally from the third bend 556.

[0088] In some embodiments, each of the first bend 536, the second bend 546, and the third bend 556 can include an acute angle. The first bend 536 can include an acute angle oriented proximally or substantially proximally. The second bend 546 can include an acute angle oriented distally or substantially distally. The third bend 556 can include an acute angle oriented proximally or substantially proximally. The first bend 536 can be distal to, proximal to, or at the same or a similar distal location as the third bend 556. In some embodiments, each of the first anchor portion 530, the second anchor portion 540, the third anchor portion 550, and the fourth anchor portion 560 can include a linear or substantially linear portion. For example, each of first anchor portion 530, second anchor portion 540, third anchor portion 550, and fourth anchor portion 560 can be linear or substantially linear, such that anchor portion 570 includes a zigzag shape. In some embodiments, anchor portions 530, 540, 550, 560 can be flexible, such that anchor portions 530, 540, 550, 560 can assume a curved configuration to follow the curvature of a vessel, channel, chamber, and / or organ within which anchor portion 570 is positioned. Alternatively, in some embodiments, each of anchor portions 530, 540, 550, 560 can include a preformed curvature to match the curvature of a vessel, channel, chamber, and / or organ. In some embodiments, anchor portions 530, 540, 550, 560 can have a curved configuration and / or a pre-formed curve to facilitate advancement of needle 500 through tortuous anatomical pathways.

[0089] The puncture needles 400, 500 described with reference to Figures 6 and 7 may have one or more other features of the puncture needle 100 described with reference to Figure 3. For example, the curved puncture portions 420, 520 and anchor portions 470, 570 of the puncture needles 400, 500 described with reference to Figures 6 and 7 may lie in the same plane and / or parallel planes, e.g., extend along lines that lie in the same plane and / or parallel planes. In some embodiments, the curved puncture portion 520, anchor portion 570, and puncture tip 580 may all lie in the same plane. The curved puncture portions 420, 520 and anchor portions 470, 570 may include respective portions that lie in the same plane. Portions of each of the curved piercing portion 420, 520 and the anchor portion 470, 570 can extend along lines contained in the same plane, such that the curved piercing portion 420, 520 and the anchor portion 470, 570 each include portions that extend along lines contained in parallel planes. In some embodiments, the curved piercing portion 520 and the anchor portion 570 can be integrally formed, for example, part of a single elongated portion.

[0090] The transverse cross-sections of the puncture needles 400, 500 described with reference to Figures 6 and 7 can each include a rounded shape (e.g., a circular shape) or, alternatively, a non-circular shape (e.g., a polygonal shape, etc.). For example, the curved puncture portions 420, 520 and the anchor portions 470, 570 can each include a transverse cross-section that includes a rounded shape (including a circular shape). Alternatively, the transverse cross-sections can include a rectangular shape. The transverse cross-sections of the curved puncture portions 420, 520 can be taken along a plane perpendicular or substantially perpendicular to the concave surface of each of the curved puncture portions 420, 520. The transverse cross-sections of the anchor portions 470, 570 can be taken along a plane perpendicular or substantially perpendicular to the longitudinal axis of each of the puncture needles 400, 500 and / or each of the anchor portions.

[0091] While the puncture needles 400, 500 described with reference to Figures 6 and 7 each include anchor portions 470, 570 that include four individual portions, it will be understood that the anchor portions can include more individual portions. For example, the anchor portions can include six individual anchor portions. In some embodiments, increasing the number of individual anchor portions can further decouple the orientation of the curved puncture portion from any rotation of the proximal portion of the puncture needle. In some embodiments, the number of individual anchor portions can be selected to provide desired stabilization in the axial orientation of the curved puncture portion while providing a low-profile puncture needle.

[0092] FIGS. 8A and 8B show a puncture needle system 800. The puncture needle system 800 can include the puncture needle 100 described with reference to FIG. 3 and a delivery catheter 802 configured to receive the puncture needle 100. Side cross-sectional views along the longitudinal axis of the delivery catheter 802 are shown in FIGS. 8A and 8B. The puncture needle 100 can be pre-loaded into the delivery catheter 802. For example, the puncture needle 100 can be positioned in the delivery catheter 802 before positioning the puncture needle system 800 at a target location to access a target tissue site (e.g., before inserting the puncture needle system 800 into a patient). FIG. 8A shows the puncture needle 100 pre-loaded in the delivery catheter 802 and in a retracted state. FIG. 8B shows the puncture needle 100 in a deployed state. Referring to FIG. 8A, the delivery catheter 802 can include a puncture needle lumen 804 configured to receive the puncture needle 100. The distal portion 806 of the delivery catheter 802 can include a side exit opening 808 configured to allow extension of the puncture needle 100 therethrough to access the target tissue site. In some embodiments, the delivery catheter 802 can include a guidewire lumen 810 configured to receive a guidewire (not shown). The delivery catheter 802 can be advanced over the guidewire to position the delivery catheter 802 at a desired location to access the target tissue site.

[0093] Insertion of the puncture needle through one or more bends in a tortuous anatomical pathway can result in undesired axial rotation of the puncture needle. Undesired rotation of the puncture needle positioned within the delivery catheter can cause misalignment of the puncture needle relative to the side exit opening, thereby preventing the desired deployment of the puncture needle from the delivery catheter and / or preventing use of the puncture needle to penetrate tissue at the target tissue site. In some embodiments, misalignment of the puncture needle can prevent effective puncture of tissue.

[0094] The anchor portion 170 can include a portion that is positioned within a portion of the puncture needle lumen 804 distal to the side exit opening 808. In the retracted state, the second bend 136 of the puncture needle 100 can be distal to the side exit opening 808. For example, a portion of the first anchor portion 130 and a portion of the second anchor portion 140 can be received within a portion of the puncture needle lumen 804 distal to the side exit opening 808. In some embodiments, positioning a portion of the anchor portion 170 distal to the side exit opening 808 can facilitate maintaining a desired axial orientation of the curved puncture portion 120 within the puncture needle lumen 804. The anchor portion 170 engages with the wall of a portion of the puncture needle lumen 804 distal to the side exit opening 808, and can reduce or eliminate undesirable rotation of the curved puncture portion 120 about the longitudinal axis of the puncture needle 100.

[0095] In the retracted state, the first bend 126 of the puncture needle 100 can be proximal to the side exit opening 808. FIG. 8A shows the puncture tip 180 proximal to the side exit opening 808. In some embodiments, the entire or substantially the entire curved puncture portion 120 can be proximal to the side exit opening 808. For example, the puncture tip 180 and the curved puncture portion 120 can be proximal to the side exit opening 808 and can be received within the puncture needle lumen 804. The first bend 126 can be proximal to the side exit opening 808. The anchor portion 170 can extend along the puncture needle lumen 804 beyond the side exit opening 808. For example, the anchor portion 170 can extend along a portion of the puncture needle lumen 804 proximal to the side exit opening 808, through a portion of the lumen 804 at the side exit opening 808, and along a portion of the puncture needle lumen 804 distal to the side exit opening 808.

[0096] In some embodiments, a portion of the curved puncture portion 120 and / or the anchor portion 170 can engage a portion of the wall of the puncture needle lumen 804 proximal to the side exit opening 808. The distal portion 102 of the puncture needle 100, including the bends 126, 136, can tend to exert a radial force on the curved puncture portion 120 and the anchor portion 170, providing a spring-loaded effect. The tendency to extend radially can increase contact between the puncture needle 100 and the lumen wall of the delivery catheter 802, thereby facilitating fixation of the position and / or orientation of the curved puncture portion 120. In some embodiments, the tendency of the anchor portion 170 and the curved puncture portion 120 to extend radially can facilitate extension of the curved puncture portion 120 through the side exit opening 808 when the puncture needle 100 is deployed. For example, when the curved puncture portion 120 is aligned with the side exit opening 808, the tendency to extend radially can encourage the curved puncture portion 120 to extend beyond the opening 808 and assume its desired curved shape.

[0097] 8B , while the puncture needle 100 is in the deployed state, at least a portion of the curved puncture portion 120 may be extended through the side exit opening 808. In some embodiments, as shown in FIG. 8B , only a portion of the curved puncture portion 120 may be extended through the side exit opening 808 in the deployed state. For example, the first bend 126 can be within the puncture needle lumen 804 proximal to the side exit opening 808. In some embodiments, the entire or substantially the entire curved puncture portion 120 may be extended beyond the side exit opening 808. For example, the first bend 126 may be released from the puncture needle lumen 804. In some embodiments, the first bend 126 may be extended beyond the side exit opening 808 in the deployed state. In some embodiments, the first bend 126 may be aligned with the side exit opening 808.

[0098] The puncture needle 100 can be translated distally relative to the delivery catheter 802 to release at least a portion of the curved puncture portion 120 through the side exit opening 808. The puncture needle 100 can be pushed to align the curved puncture portion 120 with the side exit opening 808, allowing the puncture tip 180 and at least a portion of the curved puncture portion 120 to extend through the side exit opening 808. The curved puncture portion 120 can include a shape memory material, allowing the curved puncture portion 120 to assume its desired curved configuration when the curved puncture portion 120 is freed from the constraint of the delivery catheter 802.

[0099] After an opening at the target tissue location is formed, the puncture needle 100 can be translated proximally, retracting the curved puncture portion 120 and back into the puncture needle lumen 804 through the side exit opening 808. For example, the puncture needle 100 can be pulled relative to the delivery catheter 802, retracting the curved puncture portion 120 and back into the lumen 804.

[0100] Alternatively, in some embodiments, while the puncture needle 100 is in the retracted state, at least a portion of the curved puncture portion 120 may be positioned within a portion of the puncture needle lumen 804 distal to the side exit opening 808. In some embodiments, in the retracted state, the curved puncture portion 120 can be entirely or substantially entirely distal to the side exit opening 808. The puncture needle 100 can be translated proximally relative to the delivery catheter 802, releasing at least a portion of the curved puncture portion 120 through the side exit opening 808. The puncture needle 100 can be pulled to align the curved puncture portion 120 with the side exit opening 808, extending the puncture tip 180 and at least a portion of the curved puncture portion 120 through the side exit opening 808.

[0101] FIG. 9 illustrates a needle system 900 including a delivery catheter 902 and a needle 100 received within the delivery catheter 902. The delivery catheter 902 can include a needle lumen configured to receive the needle 100. A distal portion 906 of the delivery catheter 902 can include a side exit opening 908 configured to allow extension of the needle 100 therethrough. The distal portion 906 can include a curved portion, for example, to facilitate positioning of the distal portion 906 within a target vessel, channel, chamber, and / or organ. In some embodiments, an expandable anchor 910 can be associated with the distal portion 906 of the delivery catheter 902. The expandable anchor 910 can assume an expanded state to facilitate stable positioning of the distal portion 906 at a desired location within the target vessel, channel, chamber, and / or organ. For example, the expandable anchor 910 can be associated with a curved portion of the distal portion 906. In some embodiments, the delivery catheter 902 can include a guidewire lumen extending therethrough and configured to receive a delivery catheter guidewire. The delivery catheter 902 can be advanced over the delivery catheter guidewire to position the delivery catheter 902 at a desired location to access the target tissue site.

[0102] The puncture needle system 900 can include a medical implant guidewire sheath 950 configured to receive a medical implant guidewire (not shown). The medical implant guidewire sheath 950 can include a distal portion 952 configured to couple to the curved puncture portion 120 of the puncture needle 100. In some embodiments, the distal portion 952 can be fixedly coupled to the curved puncture portion 120 such that the distal portion 952 can be translated proximally and / or distally along with the curved puncture portion 120. The distal portion 952 of the medical implant guidewire sheath 950 can be extended and / or retracted through the side exit opening 908 along with the curved puncture portion 120 of the puncture needle 100. In some embodiments, the medical implant guidewire sheath 950 can be coupled to a portion of the curved puncture portion 120. In some embodiments, the medical implant guidewire sheath 950 can be coupled to all or substantially all of the curved piercing portion 120. The medical implant guidewire sheath 950 can extend proximally from the curved piercing portion 120, for example, being received within a piercing needle lumen of the delivery catheter 902.

[0103] The medical implant guidewire sheath 950 can include a distal end 954 coupled to the curved piercing portion 120. The distal end 954 can be proximal to the first end 122 of the curved piercing portion 120. For example, the distal end 954 can be proximal to the piercing tip 180. In some embodiments, the distal end 954 can be at the first end 122, e.g., adjacent to the piercing tip 180. The medical implant guidewire sheath 950 can include a distal exit opening 956 through which the medical implant guidewire can extend. The distal exit opening 956 can be at or adjacent to the distal end 954.

[0104] After the opening is formed at the target tissue site, a medical implant guidewire may be advanced through the medical implant guidewire sheath 950. A distal portion of the medical implant guidewire may be extended through the distal exit opening 956 and into the opening formed at the target tissue site. The puncture needle system 900 (including the medical implant guidewire sheath 950) may be retracted after the medical implant guidewire is positioned through the opening formed at the target tissue site, leaving the medical implant guidewire in place. A medical implant device may then be advanced along the medical implant guidewire to the target tissue site. For example, a shunt device may be advanced along the medical implant guidewire into the opening formed on the left atrial wall to shunt blood flow from the left atrium into the coronary sinus.

[0105] 10 shows an example of a puncture needle 1000, which includes a curved anchor portion 1030 and a curved puncture portion 1020 oriented proximally or substantially proximally. A distal portion 1002 of the puncture needle 1000 can include the curved puncture portion 1020 and the curved anchor portion 1030. For example, the curved anchor portion 1030 can include a preformed curve. The puncture needle 1000 can include an elongated portion 1010, and a distal portion 1012 of the elongated portion 1010 can include the curved puncture portion 1020 and the curved anchor portion 1030. The curved anchor portion 1030 can include a portion extending distally of the curved puncture portion 1020. For example, a distal end 1032 of the curved anchor portion 1030 can be distal to the curved puncture portion 1020. The curved anchor portion 1030 can include a second end 1034 coupled to the curved piercing portion 1020. The curved piercing portion 1020 can include a first end 1022 associated with the piercing tip 1040 and a second end 1024 coupled to the second end 1034 of the curved anchor portion 1030. The curved piercing portion 1020 can include one or more features of the curved piercing portion 120 described with reference to FIG. 3. For example, the curved piercing portion 1020 can include a circular segment (e.g., semicircular, etc.). In some embodiments, the curved piercing portion 1020 can be oriented proximally. In some embodiments, the piercing tip 1040 can point proximally. In some embodiments, the piercing tip 1040 can point laterally.

[0106] The puncture needle 1000 can be received within a delivery catheter. A distal portion of the delivery catheter can include a side exit opening through which the puncture needle 1000 can extend (e.g., curved puncture portion 1020). A portion of the curved anchor portion 1030 extending distally of the curved puncture portion 1020 can be configured to engage a portion of the delivery catheter lumen distal to the side exit opening to reduce or eliminate axial rotation of the curved puncture portion 1020.

[0107] The curvature of the curved piercing portion 1020 and the curvature of the curved anchor portion 1030 can have the same orientation. As shown in Figure 10, both the curved piercing portion 1020 and the curved anchor portion 1030 can be oriented proximally. For example, the inner edge of the curvature of the curved anchor portion 1030 can include at least a portion that is oriented proximally.

[0108] In some embodiments, in the relaxed state, the curved puncture portion 1020 can have a smaller radius of curvature than the curved anchor portion 1030. For example, the degree of curvature of the curved puncture portion 1020 can be greater than that of the curved anchor portion 1030. The radius of curvature of the curved anchor portion 1030 can be selected based on the curvature of an anatomical path adjacent to or proximal to the target tissue site. For example, as described herein, the puncture needle 1000 can be configured to be inserted into the coronary sinus and perforate tissue on a portion of the left atrial wall accessible from within the coronary sinus. The radius of curvature of the curved anchor portion 1030 can be selected based on the radius of curvature of the coronary sinus into which the curved anchor portion 1030 is advanced. For example, the curved anchor portion 1030 can be shaped to follow the length of the curvature of the coronary sinus.

[0109] In some embodiments, the curved puncture portion 1020 and the curved anchor portion 1030 can be in the same plane and / or parallel planes. For example, the curved puncture portion 1020 and the curved anchor portion 1030 can extend along a line that is in the same plane and / or parallel planes. The curved puncture portion 1020 and the curved anchor portion 1030 can include respective portions that are in the same plane. The respective portions of the curved puncture portion 1020 and the curved anchor portion 1030 can extend along a line that is contained in the same plane, such that the curved puncture portion 1020 and the curved anchor portion 1030 each include portions that extend along lines that are contained in parallel planes.

[0110] The transverse cross-sections of the curved piercing portion 1020 and the curved anchor portion 1030 can include non-circular shapes (e.g., polygonal shapes (including rectangular shapes)). Alternatively, the transverse cross-sections can include rounded shapes (including circular shapes). The transverse cross-sections of the curved piercing portion 1020 and the curved anchor portion 1030 can be taken along a plane perpendicular or substantially perpendicular to the concave surfaces of the curved piercing portion 1020 and the curved anchor portion 1030, respectively.

[0111] In some embodiments, the curved piercing portion 1020 and the curved anchor portion 1030 may be integrally formed. For example, the distal portion 1012 of the elongated portion 1010 may include a curved elongated distal portion and a curved piercing portion 1020 extending from the curved elongated distal portion. The curved elongated distal portion may be the curved anchor portion 1030. The curved piercing portion 1020 may extend from a second end 1034 of the curved elongated distal portion and may extend to a piercing tip 1040.

[0112] FIG. 11 shows an example of a puncture needle 1100 including a curved anchor portion 1130 and a curved puncture portion 1120 oriented distally or substantially distally. The curved anchor portion 1120 may include a preformed curvature. An inner edge of the curve of the curved puncture portion 1120 may include at least a portion that is distally oriented. For example, a concave portion of the curved puncture portion 1120 may include at least a portion that is distally oriented. The curved puncture portion 1120 may include one or more features of the curved puncture portion 520 described with reference to FIG. 7. The curved puncture portion 1120 may include a first end 1122 associated with the puncture tip 1140 and a second end 1124 coupled to the curved anchor portion 1130. The curved anchor portion 1130 can include a second end 1134 that is coupled to the curved piercing portion 1120. In some embodiments, the curved piercing portion 1120 can include a circular segment (e.g., semicircular, etc.). In some embodiments, the piercing tip 1140 can point distally. In some embodiments, the piercing tip 1140 can point laterally.

[0113] The puncture needle 1100 may include one or more other features of the puncture needle 1000 described with reference to FIG. 10 . For example, the distal portion 1102 of the puncture needle 1100 may include a curved puncture portion 1120 and a curved anchor portion 1130. The puncture needle 1100 may include an elongated portion 1110, and the distal portion 1112 of the elongated portion 1010 may include the curved puncture portion 1120 and the curved anchor portion 1130. The curved anchor portion 1130 may include a portion extending distally of the curved puncture portion 1120, including a distal end 1132 of the curved anchor portion 1130. The curved anchor portion 1130 may be oriented proximally. In some embodiments, the curved puncture portion 1120 may have a smaller radius of curvature than the curved anchor portion 1130.

[0114] In some embodiments, the curved puncture portion 1120 and the anchor portion 1130 can include at least some portions in the same plane and / or parallel planes. For example, the curved puncture portion 1120 and the curved anchor portion 1130 can extend along lines that are in the same plane and / or parallel planes. The curved puncture portion 1120 and the curved anchor portion 1130 can include respective portions in the same plane. Each portion of the curved puncture portion 1120 and the curved anchor portion 1130 can extend along a line contained in the same plane, such that the curved puncture portion 1120 and the curved anchor portion 1130 each include portions that extend along lines contained in parallel planes. In some embodiments, the transverse cross-section of the curved puncture portion 1120 and the curved anchor portion 1130 can include a non-circular shape (e.g., a polygonal shape (including a rectangular shape)). Alternatively, the transverse cross-section can include a rounded shape (including a circular shape). In some embodiments, the curved piercing portion 1120 and the curved anchor portion 1130 may be integrally formed. For example, the distal portion 1112 of the elongated portion 1110 may include a curved elongated distal portion and a curved piercing portion 1120 extending from the curved elongated distal portion. The curved elongated distal portion may be the curved anchor portion 1130.

[0115] FIG. 12 shows an example of a puncture needle 1200, which includes a distal portion 1202 and includes an anchor portion 1230 and a curved puncture portion 1220, where the anchor portion 1230 and the curved puncture portion 1220 are integrally formed. FIG. 12 is a plan view of the puncture needle 1200, showing the curved puncture portion 1220 extended in a straight or substantially straight configuration. The curved puncture portion 1220 can include a shape-memory material, allowing the curved puncture portion 1220 to assume its desired curved configuration upon release from the constraint of the delivery catheter. The curved puncture portion 1220 can include a first end 1222 associated with a puncture tip 1240 and a second end 1224 that merges with the anchor portion 1230. The curved piercing portion 1220 and the anchor portion 1230 may be formed and / or derived from a single piece of material 1210. The distal portion 1212 of the piece of material 1210 can be split into two portions to provide the anchor portion 1230 and the curved piercing portion 1220. For example, the curved piercing portion 1220 can be cut and / or excavated from the distal portion 1212 of the piece of material 1210. The curved piercing portion 1220 can be cut and / or excavated from the piece of material 1210 such that the curved piercing portion 1220 can be released from the remainder of the piece of material 1210. The remainder of the piece of material 1210 can include the anchor portion 1230, for example, extending from location 1234 to a distal end 1232 on the distal portion 1212. In some embodiments, the curved piercing portion 1220 can be laser cut from the piece of material 1210. The released curved piercing portion 1220 can extend from a location 1234 on the distal portion 1212 of the piece of material 1210 to a first end 1222 associated with the piercing tip 1240. A surface region 1250 of the material 1210 from which the curved piercing portion 1220 is released is shown in FIG. 12. The surface region 1250 can be on the anchor portion 1230.Anchor portion 1230 can include a distally extending portion of curved piercing portion 1220, including a distal end 1232 of anchor portion 1230. For example, the distally extending portion of curved piercing portion 1220 can include a surface region 1250 thereon.

[0116] The curved puncture portion 1220 and the anchor portion 1230 can include one or more features of the curved puncture portion and anchor portion as described herein. In some embodiments, the anchor portion 1230 can be a curved anchor portion. In some embodiments, the anchor portion 1230 can include a preformed curvature. In some embodiments, both the anchor portion 1230 and the curved puncture portion 1220 can be oriented proximally. In some embodiments, the curved puncture portion 1220 can have a smaller radius of curvature than that of the curved anchor portion. In some embodiments, the anchor portion 1230 can be linear or substantially linear. The linear or substantially linear anchor portion can be flexible and adapted to conform to one or more curvatures of the vessel, channel, chamber, and / or organ into which the puncture needle 1200 is positioned.

[0117] In some embodiments, the curved puncture portion 1220 and the anchor portion 1230 can include at least some portions in the same plane and / or parallel planes, e.g., can include portions extending along lines that are in the same plane and / or parallel planes. In some embodiments, the curved puncture portion 1220 and the anchor portion 1230 can include corresponding portions in the same plane. For example, the curved puncture portion 1220 and the anchor portion 1230 can lie flat or substantially flat when laid on their sides. Respective portions of the curved puncture portion 1220 and the anchor portion 1230 can extend along lines that are contained in the same plane, such that the curved puncture portion 1220 and the anchor portion 1230 each include respective portions that extend along lines that are contained in parallel planes.

[0118] 13A and 13B illustrate a puncture needle system 1300. The puncture needle system 1300 can include the puncture needle 1000 described with reference to FIG. 10 and a delivery catheter 1302 configured to receive the puncture needle 1000. Side cross-sectional views along the longitudinal axis of the delivery catheter 1302 are shown in FIGS. 13A and 13B. FIG. 13A illustrates the puncture needle 1000 preloaded within the delivery catheter 1302 and in a retracted state. FIG. 13B illustrates the puncture needle 1000 in a deployed state. Referring to FIG. 13A, the delivery catheter 1302 can include a puncture needle lumen 1304 configured to receive the puncture needle 1000. A distal portion 1306 of the delivery catheter 1302 can include a side exit opening 1308. The puncture needle 1000 can be extended through the side exit opening 1308 to access a target tissue site.

[0119] The delivery catheter 1302 can include a guidewire lumen 1310 that extends along a predetermined length (e.g., the entire length) of the delivery catheter 1302 and is configured to receive a delivery catheter guidewire (not shown). The delivery catheter 1302 can be advanced over the delivery catheter guidewire into a blood vessel, channel, chamber, and / or organ to position the side exit opening 1308 at or adjacent to a target tissue site. In some embodiments, after the delivery catheter is advanced over the delivery catheter guidewire to a desired location within the blood vessel, channel, chamber, and / or organ, the delivery catheter guidewire can be retracted, leaving the delivery catheter in the desired location.

[0120] The anchor portion 1030 can include a portion configured to be positioned within a portion of the puncture needle lumen 1304 distal to the side exit opening 1308 in both the retracted state and the deployed state. For example, the distal end 1032 of the anchor portion 1030 can remain within the portion of the puncture needle lumen 1304 distal to the side exit opening 1308. The portion of the anchor portion 1030 distal to the side exit opening 1308 can engage a wall of the portion of the puncture needle lumen 1304 distal to the side exit opening 1308 to reduce or eliminate undesired rotation of the curved puncture portion 1020 about the longitudinal axis of the puncture needle 1000.

[0121] 13A , in the retracted state, the curved puncturing portion 1020 can remain or substantially remain within the puncture needle lumen 1304. The second end 1024 of the curved puncturing portion 1020 can be proximal to the side exit opening 1308. FIG. 13A shows the puncturing tip 1040 proximal to the side exit opening 1308. In some embodiments, the entire or substantially the entire curved puncturing portion 1020 can be proximal to the side exit opening 1308. For example, the puncturing tip 1040 and the curved puncturing portion 1020 can be proximal to the side exit opening 1308 and can be received within the puncture needle lumen 1304. The second end 1024 of the curved puncturing portion 1020 and the second end 1034 of the anchor portion 1030 can be proximal to the side exit opening 1308. The anchor portion 1030 can extend beyond the side exit opening 1308 and along the puncture needle lumen 1304. For example, the anchor portion 1030 can extend along a portion of the puncture needle lumen 1304 proximal to the side exit opening 1308, through a portion of the lumen 1304 at the side exit opening 1308, and along a portion of the puncture needle lumen 1304 distal to the side exit opening 1308.

[0122] In some embodiments, both the curved puncture portion 1020 and the anchor portion 1030 can engage corresponding portions of the delivery catheter lumen wall, preventing or reducing axial rotation of the curved puncture portion 1020. For example, the curved puncture portion 1020 and the anchor portion 1030 can have a tendency to extend radially. For example, the curved puncture portion 1020 and the anchor portion 1030 can be spring-loaded. The tendency to extend radially can increase contact between the puncture needle 1000 and the lumen wall of the delivery catheter 1302 and facilitate fixation of the position and / or orientation of the curved puncture portion 1020. In some embodiments, the tendency of the anchor portion 1030 and the curved puncture portion 1020 to extend radially can facilitate extension of the curved puncture portion 1020 through the side exit opening 1308 when the puncture needle 1000 is deployed.

[0123] 13B , in the deployed state, at least a portion of the curved puncturing portion 1020 can extend through the side exit opening 1308. In some embodiments, only a portion of the curved puncturing portion 1020 can extend through the side exit opening. For example, the second end 1024 can be within the lumen 1304 and proximal to the side exit opening 1308. Alternatively, the entire or substantially the entire curved puncturing portion 1020 can extend beyond the side exit opening 1308. For example, the second end 1024 of the curved puncturing portion 1020 and the second end 1034 of the anchor portion 1030 can be aligned with the side exit opening 1308. The entire curved puncturing portion 1020 and the puncturing tip 1040 can extend through the side exit opening 1308.

[0124] The puncture needle 1000 is translated distally relative to the delivery catheter 1302 to release at least a portion of the curved puncture portion 1020 through the side exit opening 1308, for example, to release all or substantially all of the curved puncture portion 1020. The curved puncture portion 1020 can include a shape memory material such that when the curved puncture portion 1020 is aligned with the side exit opening 1308, the curved puncture portion 1020 extends through the side exit opening 1308 and assumes its desired curved configuration. After an opening at the target tissue location is formed, the puncture needle 1000 can be translated proximally to retract the curved puncture portion 1020 and return it through the side exit opening 1308 and into the puncture needle lumen 1304. For example, the puncture needle 1000 can be pulled, causing the curved puncture portion 1020 to retract and back into the lumen 1304.

[0125] Alternatively, in some embodiments, while the puncture needle 1000 is in the retracted state, at least a portion of the curved puncture portion 1020 can be positioned within a portion of the puncture needle lumen 1304 distal to the side exit opening 1308. For example, the puncture tip 1040 can be distal to the side exit opening 1308. In some embodiments, in the retracted state, the curved puncture portion 1020 can be entirely or substantially entirely distal to the side exit opening 1308. The puncture needle 1000 can be translated proximally relative to the delivery catheter 1302 to release at least a portion of the curved puncture portion 1020 through the side exit opening 1308. The puncture needle 1000 can be pulled to align the curved puncture portion 1020 with the side exit opening 1308, so that the puncture tip 1040 and at least a portion of the curved puncture portion 1020 can be extended through the side exit opening 1308.

[0126] 14A-14D show an example of a puncture needle system 1400, which includes a delivery catheter 1402 and a puncture needle 1500. The delivery catheter 1402 can include a puncture needle lumen 1404 configured to receive the puncture needle 1500. A distal portion 1406 of the delivery catheter 1402 can include a side exit opening 1408 configured to allow a portion of the puncture needle 1500 to extend therethrough to access and form an opening at the target tissue site. The delivery catheter 1402 can include a guidewire lumen 1410 configured to receive a delivery catheter guidewire (not shown). For example, the guidewire lumen 1410 can extend along a predetermined length (e.g., the entire length, etc.) of the delivery catheter 1402 such that the delivery catheter 1402 can be advanced along the delivery catheter guidewire into a desired vessel, channel, chamber, and / or organ. In some embodiments, the delivery catheter guidewire can be withdrawn after the delivery catheter 1402 is positioned at the target location, leaving the delivery catheter 1402 in place.

[0127] 14A shows a distal portion 1502 of a puncture needle 1500. The distal portion 1502 can include a curved puncture portion 1520 coupled to an anchor portion 1530. For example, the distal portion 1512 of the elongated portion 1510 of the puncture needle 1500 can include a curved puncture portion 1520 extending from the anchor portion 1530. The anchor portion 1530 can include a distal end 1532 and a second end 1534 coupled to the curved puncture portion 1520. The curved puncture portion 1520 can include a first end 1522 associated with a puncture tip 1540 and a second end 1524 coupled to the second end 1534 of the anchor portion 1530. The anchor portion 1530 can include a portion that extends distally of the curved piercing portion 1520 , for example, including a distal end 1532 of the anchor portion 1530 .

[0128] In some embodiments, the anchor portion 1530 can have a linear or substantially linear configuration in a relaxed state. The anchor portion 1530 can be flexible. For example, the anchor portion 1530 can bend to assume a curved configuration. The anchor portion 1530 can assume the curved configuration while received within the delivery catheter 1402. For example, the anchor portion 1530 can assume the curved configuration while the delivery catheter 1402 is advanced through a tortuous anatomical pathway to a desired location to access a target tissue site and / or while the delivery catheter 1402 is positioned at or adjacent to the desired location. The radius of curvature of the anchor portion 1530 in the curved configuration can be based on the curvature of the anatomical pathway adjacent or adjacent to the target tissue site (e.g., the length of the coronary sinus adjacent or adjacent to a target tissue site on the left atrial wall, etc.). The radius of curvature of the curved piercing portion 1520 can be selected to promote effective penetration of tissue while the puncture needle 1500 is positioned at a desired location to access a target tissue site. For example, the radius of curvature can be predetermined to enable desired insertion of the curved piercing portion 1520 through the target tissue when the puncture needle 1500 is extended from the side exit opening 1408. In some embodiments, the radius of curvature of the anchor portion 1530 in the curved configuration while positioned at or proximal to the target tissue site is greater than that of the curved piercing portion 1520, and the degree of curvature of the curved piercing portion 1520 is greater than that of the anchor portion 1530. The curvature of the curved piercing portion 1520 and the curvature of the anchor portion 1530 in the curved configuration while positioned at or proximal to the target tissue site can have the same orientation, e.g., oriented proximally. In some embodiments, the piercing tip 1540 can be laterally pointed. In some embodiments, the piercing tip 1540 can be proximally sharpened.

[0129] As shown in FIG. 14A , the transverse cross-section of the anchor portion 1530 can have a non-circular shape (e.g., a polygonal shape, etc.). The transverse cross-section can be taken along a plane perpendicular or substantially perpendicular to the longitudinal axis of the puncture needle 1500. In some embodiments, the transverse cross-section of the anchor portion 1530 can be rectangular or substantially rectangular. In some embodiments, the transverse cross-sectional shape can be selected to interlock with the transverse cross-sectional shape of the delivery catheter lumen 1404 such that the anchor portion 1530 does not or substantially does not rotate axially within the lumen 1404, thereby reducing or eliminating axial rotation of the curved puncture portion 1520. The anchor portion 1530 can include at least a portion that extends distally of the side exit opening 1408 while the puncture needle 1500 is in both the retracted and deployed states. For example, the transverse cross-sectional shape of lumen 1404 distal to side exit opening 1408 can be non-circular to interlock with anchor portion 1530 .

[0130] In some embodiments, the transverse cross-section of the curved piercing portion 1520 can be non-circular. The transverse cross-section can be taken along a plane perpendicular to the concave surface of the curved piercing portion 1520. The transverse cross-section can be selected to reduce the profile of the curved piercing portion 1520, thereby facilitating a reduction in the profile of the piercing needle 1500. In some embodiments, the transverse cross-section can include a polygonal shape (including a rectangular or substantially rectangular shape). The concave surface of the curved piercing portion 1520 can be generally perpendicular to the long flat surfaces of its rectangular cross-sectional form, as in FIG. 14A .

[0131] In some embodiments, the curved puncture portion 1520 and the anchor portion 1530 can be in the same plane and / or parallel planes, e.g., extend along lines that are in the same plane and / or parallel planes. In some embodiments, the curved puncture portion 1520 and the anchor portion 1530 can be in the same plane. For example, the curved puncture portion 1520 and the anchor portion 1530 can lie flat or substantially flat when laid on their side. In some embodiments, portions of each of the curved puncture portion 1520 and the anchor portion 1530 can extend along lines that are contained in the same plane, such that the curved puncture portion 1520 and the anchor portion 1530 each include portions that extend along lines that are contained in parallel planes. In some embodiments, the curved puncture portion 1520 and the anchor portion 1530 can be integrally formed, e.g., part of a single elongated portion. For example, the distal portion 1512 of the elongate portion 1510 can include a curved piercing portion 1520 and an anchor portion 1530 .

[0132] 14B is a transverse cross-sectional view of a portion of the delivery catheter 1402 distal to the side exit opening 1408. The transverse cross-section may be taken along a plane perpendicular or substantially perpendicular to the longitudinal axis of the delivery catheter 1402. The guidewire lumen 1410 and the puncture needle lumen 1404 are shown. The guidewire lumen 1410 can include a rounded shape (e.g., a circular or substantially circular shape, etc.). The transverse cross-section of the puncture needle lumen 1404 distal to the side exit opening 1408 can include a rectangular or substantially rectangular shape.

[0133] 14C is a perspective view of a portion of the delivery catheter 1402 including the side exit opening 1408. The puncture needle system 1400 is shown with the puncture needle 1500 in a retracted position. The anchor portion 1530 is shown extending beyond the side exit opening 1408 into the puncture needle lumen 1404. The second end 1524 of the curved puncture portion 1520 and the second end 1534 of the anchor portion 1530 can be proximal to the side exit opening 1408. The anchor portion 1530 can extend along a portion of the puncture needle lumen 1404 proximal to the side exit opening 1408, through a portion of the lumen 1404 at the side exit opening 1408, and along a portion of the puncture needle lumen 1404 distal to the side exit opening 1408. The anchor portion 1530 can extend through a portion of the puncture needle lumen 1404 distal to the side exit opening 1408. The curved puncture portion 1520 can be completely or substantially completely within a portion of the puncture needle lumen 1404 proximal to the side exit opening 1408. For example, the puncture tip 1540 can be within the lumen 1404 and proximal to the side exit opening 1408. The puncture needle 1500 can be translated (e.g., pushed) distally to release the curved puncture portion 1520 through the side exit opening 1408, causing the curved puncture portion 1520 to deploy. In some embodiments, the puncture tip 1540 can be within the lumen 1404 and distal to the side exit opening 1408. The puncture needle 1500 can be translated (e.g., pushed) proximally to release the curved puncture portion 1520 through the side exit opening 1408. The curved puncture portion 1520 can include a shape memory material such that the curved puncture portion 1520 can assume its desired curved configuration once the curved puncture portion 1520 is free from the constraint of the delivery catheter 1402.

[0134] 14D shows the puncture needle system 1400 in a deployed state. The curved puncture portion 1520 is shown extending through the side exit opening 1408. In some embodiments, the curved puncture portion 1520 can extend partially through the side exit opening 1408. For example, the second end 1524 of the curved puncture portion 1520 and the second end 1534 of the anchor portion 1530 can be proximal to the side exit opening 1408. The second end 1534 is not shown in FIG. 14D because the second end 1534 is within the delivery catheter lumen 1404 and proximal to the side exit opening 1408. In some embodiments, the entire or substantially the entire curved puncture portion 1520 extends through the side exit opening. For example, the second end 1524 of the curved puncture portion 1520 and the second end 1534 of the anchor portion 1530 can be aligned with the side exit opening 1408. As described herein, while the puncture needle 1500 is in the deployed state, the anchor portion 1530 can include at least a portion that extends distally of the side exit opening 1408. In FIG. 14D , the anchor portion 1530 is shown extending through the lumen 1404 beyond the side exit opening 1408.

[0135] FIG. 15 is a flow diagram of an example process 1600 for deploying a needle system to puncture tissue at a target tissue site. The needle system may include one or more features of the needle systems described herein. In block 1602, the procedure / process 1600 involves advancing the needle system into a blood vessel. For example, the blood vessel may be the coronary sinus. The needle system may be advanced from the right atrium through the coronary sinus ostium into the coronary sinus. A transjugular or transsubclavian approach may be used to access the right atrium via the superior vena cava. Alternatively, a transfemoral approach may be used to position the needle system into the inferior vena cava and from the inferior vena cava into the right atrium. The procedure / process 1600 may include a minimally invasive transcatheter approach.

[0136] In some embodiments, a needle system can be delivered into the coronary sinus to access the left atrial wall from within the coronary sinus. The needle system can be used to access a target tissue site on the left atrial wall. The needle system can be used to create an opening on the left atrial wall for delivery of one or more medical therapies and / or implant devices. For example, an opening can be created on the left atrial wall for implanting a shunt device therein, e.g., to provide an artificial blood flow conduit for relieving elevated left atrial pressure.

[0137] The puncture needle system can include a puncture needle. The puncture needle can include one or more features of the puncture needle described herein. For example, the puncture needle can include an anchor portion and a curved puncture portion. The puncture portion can include a first end associated with the puncture tip and a second end connected to the anchor portion. The anchor portion can include a portion distal to the curved puncture portion. The puncture needle system can include a delivery catheter configured to receive the puncture needle. The delivery catheter can include a puncture needle lumen, and the puncture needle can be slidably extended through the puncture needle lumen. A side exit opening can be at a distal portion of the delivery catheter, and at least a portion of the curved puncture portion can extend therethrough.

[0138] As described herein, the puncture needle may be pre-loaded. For example, the puncture needle can be in a desired position within the delivery catheter prior to positioning the delivery catheter at the target tissue site (e.g., prior to inserting the delivery catheter into a patient). For example, a distal portion of the puncture needle can be at or adjacent to the side exit opening while the delivery catheter is advanced to the target tissue site. The puncture needle can be in a retracted state within the delivery catheter when the delivery catheter is advanced to the target tissue site. In some embodiments, while the puncture needle is in a retracted state, at least a portion of the anchor portion is positioned within a portion of the puncture needle lumen distal to the side exit opening. In some embodiments, interaction between the anchor portion and a portion of the puncture needle lumen wall distal to the side exit opening can facilitate maintaining the axial orientation of the curved puncture portion relative to the delivery catheter, regardless of any axial rotation of any portion of the puncture needle proximal to the curved puncture portion.

[0139] In some embodiments, the curved puncture portion can be positioned proximal to the side exit opening while the puncture needle is in the retracted state. In some embodiments, at least a portion of the curved puncture portion can be positioned distal to the side exit opening while the puncture needle is in the retracted state. For example, a portion of the curved puncture portion and the puncture tip can be within a portion of the puncture needle lumen distal to the side exit opening. In some embodiments, the puncture tip can be within the side exit opening, and the curved puncture portion can include at least a portion that is positioned within a portion of the puncture needle lumen proximal to the side exit opening.

[0140] In block 1604, the procedure / process 1600 involves translating the puncture needle either distally or proximally relative to the delivery catheter to release at least a portion of the curved puncture portion through the side exit opening. The puncture needle can be pushed or pulled to align the curved puncture portion with the side exit opening, such that the puncture tip and at least a portion of the curved puncture portion can extend through the side exit opening. For example, a puncture needle with a puncture tip distal to the side exit opening in a retracted state can be translated proximally relative to the delivery catheter to release at least a portion of the curved puncture portion through the side exit opening. A puncture needle with a puncture tip proximal to the side exit opening in a retracted state can be translated distally relative to the delivery catheter to release at least a portion of the curved puncture portion through the side exit opening. In some embodiments, the curved puncture portion can include a shape memory material such that when at least a portion of the curved puncture portion is freed from the constraint of the delivery catheter, the curved puncture portion can tend to assume its desired curved configuration.

[0141] At block 1606, the procedure / process 1600 involves extending at least a portion of the curved puncture portion through the side exit opening. In the deployed state, the puncture needle can include the entire or substantially the entire curved puncture portion extending beyond the side exit opening. In some embodiments, only a portion of the curved puncture portion extends beyond the side exit opening while the puncture needle is in the deployed state. As described herein, the curved puncture portion can include a preformed curvature configured to facilitate access to the target tissue site while the puncture needle system is positioned within a blood vessel, such that the preformed curvature facilitates effective penetration of the target tissue site. For example, the preformed curvature of the curved puncture portion can have a predetermined radius of curvature to facilitate accessing and / or penetrating the target tissue site on the left atrial wall while the curved puncture portion is extended from a delivery catheter positioned within the coronary sinus.

[0142] At block 1608, the procedure / process 1600 involves puncturing tissue at the target tissue site using the puncture tip of the puncture needle extended through the side exit opening to form an opening at the target tissue site.

[0143] In some embodiments, the puncture needle system can include a medical implant guidewire sheath configured to slidably receive the medical implant guidewire. The medical implant guidewire sheath can include a distal portion coupled to at least a portion of the curved puncture portion. The medical implant guidewire can be advanced through the medical implant guidewire sheath to the target tissue site. The medical implant guidewire can be advanced through an opening associated with the distal end of the medical implant guidewire sheath and into an opening formed in the target tissue site. After the medical implant guidewire is positioned at its target location, the medical implant guidewire sheath can be retracted, leaving the medical implant guidewire in place. A medical implant device (e.g., a shunt device, etc.) can then be advanced along the medical implant guidewire to the target implantation site. For example, a shunt device can be advanced along the medical implant guidewire into an opening formed on the left atrial wall.

[0144] Additional Embodiments Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different sequence, added, combined, or omitted entirely. Thus, not all described acts or events may be required to practice a process in a particular embodiment.

[0145] Conditional language used herein (e.g., "can," "could," "might," "may," and "for example," among others) is intended to have its ordinary meaning unless specifically stated otherwise or understood otherwise within the context as used, and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are somehow required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps will be included in or implemented in any particular embodiment, with or without author input or prompting. Terms such as "comprising," "including," and "having" are synonymous and are used in their ordinary sense, and are used in an open-ended, inclusive manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in its inclusive sense (not its exclusive sense), and when used, for example, to connect a list of elements, the term "or" is intended to mean one, some, or all of the elements in the list. Conjunctive language, such as the phrase "at least one of X, Y, and Z," is generally understood in the context in which it is used to convey that an item, term, element, etc. can be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is generally not intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0146] In the foregoing description of embodiments, it should be recognized that various features may be grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in understanding one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used in conjunction with any other embodiment. Furthermore, no component, feature, step, or group of components, features, or steps is necessary or essential with respect to each embodiment. Accordingly, it is intended that the scope of the invention as disclosed herein and claimed below should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the claims that follow.

[0147] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply a physical character or order. Thus, as used herein, ordinal terms (e.g., "first," "second," "third," etc.) used to modify an element (e.g., a structure, component, operation, etc.) do not necessarily indicate a priority or order of the element relative to any other elements, but rather generally may distinguish the element from other elements having similar or identical names (except for the use of ordinal terms). Additionally, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an action performed "based on" a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

[0148] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments belong. It should be further understood that terms (e.g., as defined in commonly used dictionaries) should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0149] Spatially relative terms such as "outside," "inside," "upper," "lower," "below," "upper," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another, as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the drawings. For example, in the case where a device illustrated in the drawings is turned upside down, a device positioned "below" or "under" another device may be placed "above" another device. Thus, the exemplary term "under" can include both a lower position and an upper position. Devices may also be oriented in other directions, and thus spatially relative terms may be interpreted differently depending on the orientation.

[0150] Unless expressly stated otherwise, comparative and / or quantitative terms (e.g., "less than," "more than," and "greater than," etc.) are intended to encompass equivalence. For example, "less than" can mean "less than" in the strictest mathematical sense, as well as "less than or equal to." [Explanation of symbols]

[0151] 1. Heart 2 left atrium 3 left ventricle 4 Right ventricle 5 Right atrium 6. Mitral valve 7. Aortic valve 8 Tricuspid valve 9 Pulmonary valve 10 septum 11. Pulmonary artery 12 aorta 13 Right pulmonary artery 14 Left pulmonary artery 15. Inferior vena cava 16 Superior vena cava 17 Coronary sinus ostium 18 Coronary sinus 100 puncture needle 102 Distal portion 110 Long and thin part 112 Distal portion 120 curved puncture part 122 first end 124 Second End 126 First Bend 130 First anchor part 132 first end 134 Second End 136 Second Bend 140 Second Anchor Part 142 first end 170 Anchor part 180 Puncture tip 200 puncture needle 202 Distal part 210 Long and thin part 212 Distal part 220 Curved puncture part 222 first end 224 Second End 226 First Bend 230 First anchor part 232 first end 234 Second End 236 Second Bend 240 Second Anchor Part 242 First End 270 Anchor part 280 Puncture tip 300 puncture needle 302 Distal part 310 Long and thin part 312 Distal part 320 curved puncture part 322 first end 324 Second End 326 First Bend 330 first curved anchor portion 332 First End 334 Second End 336 Second Bend 340 Second curved anchor portion 370 Anchor part 380 Puncture tip 400 puncture needle 402 Distal part 410 Thin section 412 Distal part 420 curved puncture part 422 First End 424 Second End 426 First Bend 430 First anchor part 432 First End 434 Second End 436 Second Bend 440 Second Anchor Part 442 First End 444 Second End 446 Third Bend 450 Third Anchor Part 452 First End 454 Second End 456 Fourth Bend 460 Fourth Anchor Part 462 First End 470 Anchor part 480 Puncture tip 500 puncture needle 502 distal portion 510 Thin part 512 Distal part 520 Curved puncture part 522 first end 524 Second End 530 First anchor part 532 first end 534 Second End 536 First Bend 540 Second Anchor Part 542 first end 544 Second End 546 Second Bend 550 Third Anchor Part 552 first end 554 Second End 556 Third Bend 560 Fourth Anchor Part 562 First End 570 Anchor part 580 Puncture tip 800 Needle System 802 Delivery catheter 804 Puncture needle lumen 806 Distal part 808 Side Exit Opening 810 Guidewire lumen 900 Needle System 902 Delivery catheter 906 Distal part 908 Side Exit Opening 910 Expandable Anchor 950 Medical Implant Guide Wire Sheath 952 Distal part 954 Distal end 956 Distal Exit Orifice 1000 puncture needles 1002 Distal portion 1010 Long and thin part 1012 Distal part 1020 curved puncture part 1022 first end 1024 second end 1030 curved anchor part 1032 distal end 1034 second end 1040 Puncture tip 1100 Puncture needle 1102 Distal part 1112 Distal part 1120 curved puncture part 1122 first end 1124 second end 1130 curved anchor part 1132 distal end 1134 Second end 1140 Puncture tip 1200 puncture needle 1202 Distal part 1210 Material 1212 Distal part 1220 Curved puncture part 1222 first end 1224 Second end 1230 Anchor part 1232 distal end 1234 position 1240 Puncture tip 1250 surface area 1300 Needle System 1302 Delivery catheter 1304 Puncture needle lumen 1306 Distal part 1308 Side Exit Opening 1310 Guidewire lumen 1400 Needle System 1402 Delivery catheter 1404 Puncture needle lumen 1406 Distal part 1408 Side Exit Opening 1410 Guidewire lumen 1500 puncture needle 1502 Distal part 1510 Long and thin part 1512 Distal part 1520 curved puncture part 1522 first end 1524 Second end 1530 Anchor part 1532 distal end 1534 Second end 1540 Puncture tip

Claims

1. A puncture needle, the puncture needle comprising: a piercing tip configured to pierce tissue; The distal part and Including, The distal portion comprises: An anchor part, a curved piercing portion, the curved piercing portion including a first end associated with the piercing tip and a second end coupled to the anchor portion, the anchor portion including a portion distal to the curved piercing portion; Including, the curved piercing portion is distally oriented, the piercing tip pointing distally; A puncture needle, wherein at least a portion of an inner edge of the curve of the curved puncture portion is oriented distally.

2. The puncture needle of claim 1 , wherein the curved puncture portion comprises a circular segment.

3. The puncture needle of claim 2 , wherein the curved puncture portion comprises a semicircular shape.

4. The puncture needle according to claim 1 , wherein the distal portion includes a transverse cross-section having a rectangular shape, the transverse cross-section being taken along a plane perpendicular to a longitudinal axis of the puncture needle.

5. 5. The puncture needle according to claim 1, wherein the anchor portion is a curved anchor portion, the curved anchor portion including a portion distal to the curved puncture portion and a proximal portion connected to the second end of the curved puncture portion.

6. The puncture needle of claim 5 , wherein the curved anchor portion and the curved puncture portion include the same orientation.

7. The puncture needle according to claim 5 or 6, wherein the radius of curvature of the curved puncture portion is smaller than the radius of curvature of the curved anchor portion.

8. A puncture needle, the puncture needle comprising: a piercing tip configured to pierce tissue; an elongated portion including a distal portion, the distal portion including a curved elongated distal portion and a curved piercing portion, the curved piercing portion extending from the curved elongated distal portion to the piercing tip; Including, the curved elongate distal portion and the curved piercing portion have the same orientation; a distal end of the curved elongated distal portion distal to the curved piercing portion; the curved piercing portion is distally oriented, the piercing tip pointing distally; A puncture needle, wherein at least a portion of an inner edge of the curve of the curved puncture portion is oriented distally.

9. The puncture needle of claim 8 , wherein the radius of curvature of the curved elongate distal portion is greater than the radius of curvature of the curved puncture portion.

10. 1. A puncture needle system, comprising: A puncture needle, a delivery catheter and Including, The puncture needle includes a puncture tip and a distal portion, the distal portion including: An anchor part, a curved piercing portion, the curved piercing portion including a first end associated with the piercing tip and a second end coupled to the anchor portion, the anchor portion including a portion distal to the curved piercing portion; Including, 1. A puncture needle system, wherein the delivery catheter includes a lumen, the puncture needle extending through the lumen, the delivery catheter including a side exit opening at a distal portion of the delivery catheter, the side exit opening configured to allow at least a portion of the curved puncture portion to extend therethrough, and the anchor portion extending through a distal portion of the lumen distal to the side exit opening.

11. 11. The puncture needle system of claim 10, wherein the distal portion of the lumen distal to the side exit opening comprises a transverse cross-section that comprises a non-circular shape, the transverse cross-section being taken along a plane perpendicular to a longitudinal axis of the delivery catheter.

12. The needle system of claim 11 , wherein the transverse cross-section of the distal portion of the lumen comprises the same shape as the transverse cross-section of the anchor portion.

13. 13. The puncture needle system of claim 10, further comprising a medical implant guidewire sheath configured to slidably receive a medical implant guidewire, the medical implant guidewire sheath comprising a distal portion coupled to at least a portion of the curved puncture portion.

14. 14. The puncture needle system of claim 10, wherein the anchor portion is a curved anchor portion, the curved anchor portion including a portion distal to the curved puncture portion and a proximal portion coupled to the second end of the curved puncture portion.

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