Transcatheter puncture needle system

Abstract

A puncture needle can include a puncture tip configured to pierce tissue, and a distal portion including an anchor portion and a curved puncture portion. The curved puncture portion can include a first end associated with the puncture tip and a second end coupled to the anchor portion, where the anchor portion includes a portion distal of the curved puncture portion. A puncture needle system can include the puncture needle and a delivery catheter including a lumen through which the puncture needle extends. The delivery catheter can have a side exit opening on a distal portion of the delivery catheter configured to allow at least a portion of the curved puncture portion to extend therethrough, where the anchor portion extends through a portion of the lumen distal of the side exit opening.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 902,747, filed September 19, 2019, entitled “TRANSCATHETER PUNCTURE NEEDLE SYSTEM”, the disclosure of which is expressly incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure generally relates to the field of transcatheter needles for delivering medical implants and / or therapies. Background Technology

[0004] The delivery of a puncture needle via catheter to a target blood vessel, channel, chamber, and / or organ can be performed in a minimally invasive procedure to create an opening at the target tissue site. This opening can be configured to allow medical implants and / or therapies to be delivered to the target tissue site. For example, delivery of an implantable device and / or therapy to the heart can be performed to treat elevated pressure in the left atrium. Summary of the Invention

[0005] This article describes devices, systems, and methods related to transcatheter puncture needles. Puncture needles can be used for minimally invasive procedures that create openings at target tissue sites, including the left atrial wall within the heart.

[0006] In some embodiments, the puncture needle may include a puncture tip configured to puncture tissue and an elongated portion. The elongated portion may include a distal portion comprising a curved puncture portion having a first end associated with the puncture tip and extending from the first end to a first bend having a first acute angle oriented distally; a first distal elongated portion, which intersects with the curved puncture portion at the first bend and extends from the first bend to a second bend having a second acute angle oriented proximally; and a second distal elongated portion, which intersects with the first distal elongated portion at the second bend and extends proximally from the second bend. The second bend may be distal to the curved puncture portion.

[0007] In some embodiments, the first distal elongated portion, the second distal elongated portion, and the curved puncture portion are in a plane. In some embodiments, the elongated portion is a single wire.

[0008] In some embodiments, the first distal elongated portion includes a first distal curved portion and the second distal elongated portion includes a second distal curved portion, the first distal curved portion and the second distal curved portion having the same orientation as the curved puncture portion. In some embodiments, the radius of curvature of the curved puncture portion is smaller than the radius of curvature of each of the first distal curved portion and the second distal curved portion.

[0009] In some embodiments, the puncture needle may include a puncture tip configured to puncture tissue, and an elongated portion including a distal portion comprising a curved distal elongated portion and a curved puncture portion extending from the curved distal elongated portion to the puncture tip. The curved distal elongated portion and the curved puncture portion may have the same orientation. The distal end of the curved distal elongated portion may be distal to the curved puncture portion.

[0010] In some embodiments, the radius of curvature of the curved distal elongated portion is greater than the radius of curvature of the curved puncture portion.

[0011] In some embodiments, the puncture needle may include a puncture tip configured to puncture tissue and a distal portion. The distal portion may include an anchoring 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 anchoring portion. The anchoring portion may include a portion distal to the curved puncture portion.

[0012] In some embodiments, the curved puncture portion is oriented proximally, and the puncture tip points proximally. In some embodiments, the curved puncture portion is oriented distally, and the puncture tip points distally.

[0013] In some embodiments, the curved puncture portion includes a circular segment. In some embodiments, the curved puncture portion includes a semicircle.

[0014] In some embodiments, the distal portion includes a transverse section having a rectangular shape, which is cut along a plane perpendicular to the longitudinal axis of the puncture needle.

[0015] In some embodiments, the anchoring portion is a curved anchoring portion, which 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 anchoring portion and the curved puncture portion have 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 anchoring portion. In some embodiments, the curved anchoring portion includes a curvature configured to conform to the length of the coronary sinus.

[0016] In some embodiments, the anchoring portion may include a first anchoring portion and a second anchoring portion. The first anchoring portion includes a first end and a second end, wherein the first end of the first anchoring portion is coupled to the curved puncture portion; the second anchoring portion includes a first end coupled to the second end of the first anchoring portion, and wherein the second anchoring portion extends proximally from the first end of the second anchoring portion. The first anchoring portion and the second anchoring portion may meet at a bend, wherein the bend may be proximally oriented and may be distal to the curved puncture portion. In some embodiments, the bend includes an acute angle.

[0017] In some embodiments, the curved puncture portion, the first anchoring portion, and the second anchoring portion are in a plane. In some embodiments, the first anchoring portion is a first curved anchoring portion and the second anchoring portion is a second curved anchoring portion. In some embodiments, the curved puncture portion, the first curved anchoring portion, and the second curved anchoring portion have the same orientation. In some embodiments, the radius of curvature of the curved puncture portion is smaller than the radius of curvature of each of the first curved anchoring portion and the second curved anchoring portion. In some embodiments, the first curved anchoring portion and the second curved anchoring portion each include a shape configured to conform to the curvature along the length of the coronary sinus.

[0018] In some embodiments, the first anchoring portion and the second anchoring portion are each straight portions. In some embodiments, the curved puncture portion is oriented proximally, wherein the first end of the curved puncture portion and the first end of the first anchoring portion meet at a first bend oriented distally, wherein the first anchoring portion and the second anchoring portion meet at a second bend oriented proximally.

[0019] In some embodiments, the puncture needle system may include a puncture needle and a delivery catheter. The puncture needle may include a puncture tip and a distal portion. The distal portion may include an anchoring 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 anchoring portion, the anchoring portion including a portion distal to the curved puncture portion. The delivery catheter may include a lumen and a side outlet opening on the distal portion of the delivery catheter through which the puncture needle extends, the side outlet opening being configured to allow at least a portion of the curved puncture portion to extend through it, wherein the anchoring portion extends through the distal portion of the lumen distal to the side outlet opening.

[0020] In some embodiments, the distal portion of the lumen distal to the side outlet opening includes a transverse section having a non-circular shape, the transverse section being cut along a plane perpendicular to the longitudinal axis of the delivery catheter. In some embodiments, the transverse section of the distal portion of the lumen includes the same shape as the transverse section of the anchoring portion.

[0021] In some embodiments, the system includes a medical implantable guidewire sheath configured to slidably receive a medical implantable guidewire, the medical implantable guidewire sheath including a distal portion coupled to at least a portion of a curved puncture portion.

[0022] In some embodiments, the anchoring portion is a curved anchoring portion, which includes a portion distal to the curved puncture portion and a proximal portion coupled to a second end of the curved puncture portion.

[0023] In some embodiments, the anchoring portion includes a first anchoring portion and a second anchoring portion. The first anchoring portion includes a first end and a second end, wherein the first end of the first anchoring portion is coupled to the curved puncture portion. The second anchoring portion includes a first end coupled to the second end of the first anchoring portion, and wherein the second anchoring portion extends proximally from the first end of the second anchoring portion. The first anchoring portion and the second anchoring portion may meet at a bend, wherein the bend is oriented proximally and is distal to the curved puncture portion.

[0024] In some embodiments, the curved puncture portion, the first anchoring portion, and the second anchoring portion are in a plane.

[0025] In some embodiments, the first anchoring portion is a first curved anchoring portion and the second anchoring portion is a second curved anchoring portion, wherein the curved puncture portion, the first curved anchoring portion and the second curved anchoring portion have the same orientation.

[0026] In some embodiments, the first anchoring portion and the second anchoring portion are each straight portions.

[0027] In some embodiments, when the puncture needle is in the retracted state, the puncture tip is configured to be proximal to the side outlet opening, and the anchoring portion includes a portion extending along the lumen through the side outlet opening and through a portion of the lumen distal to the side outlet opening.

[0028] In some embodiments, when the puncture needle is in the retracted state, the puncture tip is configured to be distal to the side outlet opening, and the anchoring portion extends distally through a portion of the lumen distal to the side outlet opening.

[0029] In some embodiments, a method for delivering a puncture needle may include advancing a puncture needle system into a blood vessel. The puncture needle system may include a puncture needle and a delivery catheter. The puncture needle may include a distal portion comprising an anchoring portion and a curved puncture portion, the curved puncture portion including a first end associated with a puncture tip and a second end coupled to the anchoring portion, the anchoring portion including a portion distal to the curved puncture portion. The delivery catheter may include a puncture needle lumen and a side outlet opening on a portion of the delivery catheter, the puncture needle slidably extending through the puncture needle lumen, the side outlet opening being configured to allow at least a portion of the curved puncture portion to extend through therethrough. The method may include one of: translating the puncture needle distally or proximally relative to the delivery catheter to release at least a portion of the curved puncture portion through the side outlet opening; and puncturing tissue at a target tissue site using a puncture tip extending through the side outlet opening to form an opening at the target tissue site.

[0030] In some embodiments, the system further includes a medical implantable guidewire sheath configured to slidably receive a medical implantable guidewire, the medical implantable guidewire sheath including a distal portion coupled to at least a portion of the curved puncture portion, the method further including advancing the medical implantable guidewire within the medical implantable guidewire sheath and through an opening associated with the distal end of the medical implantable guidewire sheath into an opening formed at the target tissue site.

[0031] In some embodiments, advancing the puncture needle system into the blood vessel includes advancing the puncture needle system into the coronary sinus. In some embodiments, puncturing tissue at the target tissue site includes puncturing tissue in the left atrial wall.

[0032] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features are described herein. It should be understood that not all of these advantages can necessarily be achieved according to any particular embodiment. Therefore, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein, without necessarily achieving other advantages as taught or suggested herein. Attached Figure Description

[0033] The various embodiments depicted in the accompanying drawings are for illustrative purposes and should not in any way be construed as limiting the scope of the invention. Furthermore, 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 correspondences between reference elements. However, it should be understood that the use of similar reference numerals in conjunction with multiple drawings does not necessarily imply similarity between the various embodiments associated therewith. Furthermore, it should be understood that the features in the various drawings are not necessarily drawn to scale, and the dimensions shown are presented for the purpose of illustrating aspects of the invention. Typically, some illustrated features may be relatively smaller than those illustrated in some embodiments or constructions.

[0034] Figure 1 It is a cross-sectional view of the human heart.

[0035] Figure 2 This is another cross-sectional view of the human heart.

[0036] Figure 3 An example of a puncture needle according to one or more embodiments is shown.

[0037] Figure 4 An example of a puncture needle comprising a plurality of rounded bends on the distal portion of the puncture needle, according to one or more embodiments, is shown.

[0038] Figure 5 An example of a puncture needle including an anchoring portion according to one or more embodiments is shown, the anchoring portion including a first curved anchoring portion and a second curved anchoring portion.

[0039] Figure 6 An example of a puncture needle including an anchoring portion according to one or more embodiments is shown, the anchoring portion including a first anchoring portion, a second anchoring portion, a third anchoring portion and a fourth anchoring portion.

[0040] Figure 7 An example of a puncture needle including an anchoring portion according to one or more embodiments is shown, the anchoring portion including a first anchoring portion, a second anchoring portion, a third anchoring portion and a fourth anchoring portion.

[0041] Figure 8A and Figure 8B The illustration includes, according to one or more embodiments Figure 3 The puncture needle system has the puncture needle in both a retracted and an extended state.

[0042] Figure 9 A puncture needle system including a medical implantable guidewire sheath is shown according to one or more embodiments.

[0043] Figure 10 An example of a puncture needle according to one or more embodiments is shown, the puncture needle including a curved anchoring portion and a curved puncture portion oriented proximally.

[0044] Figure 11 An example of a puncture needle according to one or more embodiments is shown, the puncture needle including a curved anchoring portion and a distally oriented curved puncture portion.

[0045] Figure 12 An example of a puncture needle according to one or more embodiments is shown, the puncture needle including an integrally formed curved anchoring portion and a curved puncture portion.

[0046] Figure 13A and Figure 13B The illustration includes references according to one or more embodiments. Figure 10 The described puncture needle system has the puncture needle in a retracted state and an extended state.

[0047] Figure 14A , Figure 14B , Figure 14C and Figure 14D Another example of a puncture needle system according to one or more embodiments is shown.

[0048] Figure 15 This is a flowchart illustrating an example of a process for deploying a puncture needle system for piercing tissue at a target tissue site, according to one or more embodiments. Detailed Implementation

[0049] The titles provided in this document are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0050] This disclosure relates to devices, systems, and methods for minimally invasive transcatheter delivery of a puncture needle to a target tissue site in a blood vessel, passageway, chamber, and / or organ. The puncture needle described herein may have a configuration that reduces or eliminates axial rotation of the puncture needle relative to a delivery catheter receiving the puncture needle, while the delivery catheter and puncture needle are advanced to the target tissue site via a tortuous anatomical path.

[0051] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, modifications, and equivalents thereof. Therefore, the scope of the claims that may arise therefrom is not limited to any particular embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process can be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as multiple discrete operations in a manner that aids in understanding certain embodiments; however, the order of description should not be construed as implying that these operations are order-dependent. Furthermore, the structures, systems, and / or apparatuses described herein may be embodied as integrated components or separate components. Certain aspects and advantages of these embodiments are described for the purpose of comparing various embodiments. Not all of these aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be performed in a manner that achieves or optimizes one or a set of advantages as taught herein, without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0052] Regarding preferred embodiments, certain standard anatomical terms of orientation are used herein to refer to anatomical structures of animals (i.e., humans). While certain spatial relative terms, such as “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe the spatial relationship between one device / element or anatomical structure and another device / element or anatomical structure, it should be understood that these terms are used herein for the convenience of describing the positional relationship between elements / structures (as illustrated in the figures). It should be understood that, in addition to the orientations depicted in the figures, spatial relative terms are intended to encompass different orientations of elements / structures in use or operation. For example, an element / structure described as “above” another element / structure may indicate a position below or beside such other element / structure relative to the subject patient or the alternating orientation of the element / structure, and vice versa.

[0053] In minimally invasive procedures, delivering a typical puncture needle via catheter to blood vessels, channels, cavities, and / or organs can be challenging due to the difficulty in reliably controlling the axial orientation of the needle. When inserted through one or more bends in the anatomical pathway to reach a target site accessible from within a blood vessel, channel, cavity, and / or organ, the needle may undesirably rotate about its longitudinal axis. The needle may be received within a delivery catheter. A typical puncture needle can rotate axially relative to the delivery catheter as the delivery catheter and / or the needle is advanced to the target tissue site, resulting in misalignment of the needle relative to the delivery catheter. This misalignment can prevent the needle from unfolding from the delivery catheter and / or alter the needle's exit trajectory as it extends from the delivery catheter, thus hindering effective puncture of tissue at the target site.

[0054] In procedures that create an opening in the left atrial wall separating the coronary sinus from the left atrium, a puncture needle can be delivered via catheter into the coronary sinus. An opening in the left atrial wall can be created for the delivery of a medical device implant and / or therapy to the left atrial wall. For example, a shunt device can be delivered into an opening in the left atrial wall to provide a blood flow channel from the left atrium to the coronary sinus for the treatment of elevated left atrial pressure. Typical needle delivery via catheter into the coronary sinus may result in undesirable axial rotation of the needle within the lumen of the delivery catheter, leading to significant deviation in needle orientation. Incorrect needle orientation within the lumen may interfere with or prevent the formation of the desired opening in the left atrial wall, potentially contributing to improper placement of the medical device implant and / or inadequate therapy delivery.

[0055] This disclosure provides apparatus, systems, and methods related to minimally invasive catheter-based delivery of a puncture needle to a target tissue site. A puncture needle is described herein configured to maintain a desired axial orientation as it is inserted into a target site via one or more bends in an anatomical pathway. In some embodiments, the puncture needle system may include a puncture needle and a delivery catheter configured to receive the puncture needle. The delivery catheter may include a puncture needle lumen and a side outlet opening on a distal portion, the puncture needle lumen being configured to receive the puncture needle and the side outlet opening being configured to allow the puncture needle to extend through therethrough to puncture tissue. The puncture needle may include one or more features configured to engage with the lumen wall of the delivery catheter 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 may include an anchoring portion and a curved puncture portion. The curved puncture portion may have a first end associated with a puncture tip configured to puncture tissue and a second end coupled to the anchoring portion. The anchoring portion may be configured to interact with the lumen wall of the delivery catheter to prevent or reduce axial rotation of the curved puncture portion. The anchoring portion may include a portion extending distal to the curved puncture portion. In some embodiments, the portion of the anchoring portion extending distal to the curved puncture portion may engage with a portion of the delivery catheter lumen wall distal to the lateral outlet opening to prevent or reduce axial rotation of the curved puncture portion.

[0056] In some embodiments, the anchoring portion may include multiple portions converging at one or more bends, such that the bend puncture portion and the anchoring portion may include a serrated shape. In some embodiments, the multiple portions of the anchoring portion may each be straight or substantially straight. For example, the multiple portions of the anchoring portion may be straight or substantially straight in a relaxed state. The straight or substantially straight portions may be flexible, such that the portions of the anchoring portion may present a curved configuration within the lumen of the delivery catheter as the delivery catheter bends during advancement through a tortuous anatomical path. In some embodiments, the anchoring portion may be a flexible portion configured to present a curved shape when positioned at or near a target tissue site. In some embodiments, the multiple portions of the anchoring portion may each be curved, for example, including a pre-formed curvature. In some embodiments, the anchoring portion may be a curved portion. For example, the anchoring portion may be a pre-formed curved portion. One or more pre-formed curved anchoring portions may be flexible to facilitate advancement of the puncture needle through a tortuous anatomical path and / or at or near a target tissue site.

[0057] In some embodiments, one or more of the puncture needles described herein may include a curved puncture portion and / or anchoring portion having a transverse cross-section with a non-circular shape to provide a reduced profile for the puncture needle. In some embodiments, the transverse cross-section may have a rectangular or substantially rectangular shape. Alternatively, in some embodiments, the transverse cross-section may have a circular, including circular or substantially circular, shape. The transverse cross-section may be cut along a plane perpendicular to or substantially perpendicular to the longitudinal axis of the puncture needle.

[0058] In some embodiments, the puncture needle and / or puncture needle system described herein may be configured for positioning within the coronary sinus to reach a target site on the left atrial wall. The puncture needle described herein may be used to create an opening in the left atrial wall, allowing a medical implantable device, including a shunt device (e.g., an expandable shunt), to be positioned on the left atrial wall. The shunt device may provide a blood flow pathway from the left atrium to the coronary sinus to alleviate elevated left atrial pressure.

[0059] The needle system can be advanced from the right atrium into the coronary sinus via the coronary ostium. The right atrium can be accessed via the superior vena cava (SVC) or the inferior vena cava (IVC). A transjugular or subclavian approach can be used to access the right atrium via the SVC. 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 path. One or more bends can tend to axially rotate the needle. For example, advancing the needle system from the right atrium into the coronary sinus via the coronary ostium may involve one or more bends, which may result in a torsional force on the needle, thus tending to rotate it. An anchoring portion can engage one or more portions of the lumen wall of the delivery catheter to reduce or eliminate axial rotation of the bends, effectively separating the axial orientation of the bends from any axial rotation of the needle portion proximal to the bends. The anchoring portion can engage with a portion of the delivery catheter lumen wall distal to the lateral outlet opening, such that the axial orientation of the curved puncture portion is unaffected or substantially unaffected by the axial rotation of the more proximal portion of the puncture needle.

[0060] In some embodiments, one or more of the puncture needles described herein may include an integrally formed anchoring portion and a curved puncture portion. In some embodiments, the anchoring portion and the curved puncture portion may be integrally formed using a single elongated portion. For example, the single elongated portion may be formed from a single material piece (e.g., a single metallic material piece, a single polymeric material piece). In some embodiments, the single material piece may be segmented to provide the anchoring portion and the curved puncture portion. For example, the curved puncture portion may be engraved and / or cut from the material piece to separate the curved puncture portion from the remaining portion of the material piece, including the anchoring portion. In some embodiments, forming the anchoring portion and the curved puncture portion from a single material piece may reduce or eliminate locations where failure is more likely, such as locations where two materials are joined together. In some embodiments, the anchoring portion and the curved puncture portion may be formed using multiple different material pieces joined together (e.g., bonded, welded, glued).

[0061] While the needle and / or needle system described herein primarily for access to the heart, it should be understood that the use of the needle and / or needle system is not limited thereto. The needle and / or needle system can be used to access any number of blood vessels, passages, chambers, and / or organs involving the advancement of the needle and / or needle system through an anatomical pathway having one or more bends that may tend to axially rotate the needle.

[0062] The term “associated” is used herein in its broad and general sense. For example, when a first feature, element, component, device, or member is described as being “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 coupled, attached, or connected to, integrated with, at least partially embedded in, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly.

[0063] The term “catheter” and / or “delivery catheter” as used herein may generally refer to or be applicable to any type of elongated tubular delivery device, including internal lumens configured to slidably receive instruments (e.g., instruments for positioning within the atrium or coronary sinus, including, for example, delivery sheaths and / or cannulas).

[0064] refer to Figure 1Various features of the heart 1 are described to aid in understanding this disclosure. The heart 1 comprises four chambers: the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. A muscular wall called the diaphragm 10 separates the left atrium 2 and the right atrium 5, as well as the left ventricle 3 and the right ventricle 4. Blood flow through the heart 1 is controlled at least partially by four valves: the mitral valve 6, the aortic valve 7, the tricuspid valve 8, and the pulmonary valve 9. The mitral valve 6 separates the left atrium 2 and the left ventricle 3 and controls the blood flow between them. The aortic valve 7 separates and controls the blood flow between the left ventricle 3 and the aorta 12. The tricuspid valve 8 separates the right atrium 5 and the right ventricle 4 and controls the blood flow between them. The pulmonary valve 9 separates the right ventricle 4 and the pulmonary artery 11 and controls the blood flow between them.

[0065] In a healthy heart, heart valves open and close appropriately in response to pressure gradients present during various phases of the cardiac cycle (e.g., diastole and systole) to at least partially control the flow of blood to corresponding areas of the heart and / or blood vessels. Deoxygenated blood arriving from other parts of the body generally flows into the right side of the heart for delivery to the lungs, while oxygenated blood from the lungs generally flows into the left side of the heart for delivery to other parts 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 to flow into the right ventricle 4, and oxygenated blood arrives from the pulmonary veins into the left atrium 2 to flow into the left ventricle 3. During ventricular systole, deoxygenated blood from the right ventricle 4 may flow into the pulmonary artery 11 for delivery to the lungs (e.g., via the left pulmonary artery 14 and right pulmonary artery 13), and oxygenated blood may flow from the left ventricle 3 into the aorta 12 for delivery to other parts of the body.

[0066] Many conditions can contribute to higher-than-normal pressure in the left atrium. Mitral valve dysfunction can contribute to elevated left atrial pressure. Conditions such as mitral regurgitation and / or stenosis can make it difficult to pump blood from the left atrium to the left ventricle, thus contributing to elevated pressure in the left atrium. Valvular stenosis can cause the valve to narrow or become blocked. Mitral stenosis can restrict blood flow from the left atrium to the left ventricle. Valvular regurgitation occurs when the valve does not close properly. For example, regurgitation can occur due to improper closure of the valve leaflets. When the left ventricle 3 contracts, mitral regurgitation can cause blood to leak from the left ventricle 3 back into the left atrium 2. Restricted blood flow from the left atrium 2 into the left ventricle 3, and blood leakage from the left ventricle 3 back into the left atrium 2, can both contribute to elevated atrial pressure. Left ventricle 3 dysfunction can also contribute to elevated left atrial pressure. Elevated left atrial pressure can lead to left atrial enlargement, causing symptoms such as exertional shortness of breath, fatigue, chest pain, syncope, abnormal heartbeat, and leg swelling.

[0067] Figure 2This is another view of the heart 1, showing the coronary sinus 18 surrounding the left atrium 2. To alleviate elevated left atrial pressure, a catheter can be provided to allow blood to flow from the left atrium 2 into a lower-pressure portion of the heart, such as the coronary sinus 18. The catheter can be formed in the wall of the left atrium 2 adjacent to the coronary sinus 18 to allow blood to 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 transferred from the left atrium 2 to the coronary sinus 18 can then be delivered into the right atrium 5. A shunt can be positioned on the left atrial wall (e.g., in an orientation accessible from the coronary sinus 18) to form a blood flow path from the left atrium 2 to the coronary sinus 18. Access to the coronary sinus 18 may include navigation into the right atrium 5 and entry through the coronary sinus ostium 17.

[0068] Figure 3 This 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 may include a curved puncture portion 120 and an anchoring portion 170. For example, the puncture needle 100 may include an elongated portion 110, and the distal portion 112 of the elongated portion 110 may include a curved puncture portion 120 and an anchoring portion 170. The puncture needle 100 may 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 anchoring portion 170 may 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 anchoring portion 170 may include a portion extending distally to the curved puncture portion 120. In some embodiments, a portion of the anchoring portion 170 extending distally to the curved puncture portion 120 may engage a corresponding portion of the wall of the delivery catheter lumen to facilitate maintaining the desired axial orientation of the curved puncture portion 120. In some embodiments, both the anchoring portion 170 and the curved puncture portion 120 may be configured to engage one or more portions of the delivery catheter lumen wall to reduce or eliminate rotation of the curved puncture portion 120. As described further in detail herein, when the puncture needle 100 is positioned within or substantially within the delivery catheter (e.g., when the puncture needle 100 is in a retracted position), the curved puncture portion 120 and the anchoring portion 170 may engage with corresponding portions of the delivery catheter lumen wall to prevent or reduce axial rotation of the curved puncture portion 120.

[0069] The curved puncture portion 120 may include a first end 122 associated with a puncture tip 180. The puncture tip 180 may be configured to puncture tissue at a target tissue site. The curved puncture portion 120 may include a second end 124 coupled to an anchoring portion 170. The radius of curvature of the curved puncture portion 120 may be selected to facilitate tissue puncture and / or the formation of a desired opening at the target tissue site. As the curved puncture portion 120 extends from the delivery catheter, the curvature may facilitate insertion of the puncture needle 100 into the tissue at the target tissue site. The curved puncture portion 120 may include a pre-formed curvature configured to facilitate access to the target tissue site when the puncture needle 100 is positioned in a blood vessel, channel, chamber, and / or organ, thereby facilitating effective puncture of the target tissue site. For example, in a relaxed state, as the curved puncture portion 120 extends from the lateral outlet opening of the delivery catheter positioned in the coronary sinus, the radius of curvature of the pre-formed curvature of the curved puncture portion 120 can facilitate access to and / or puncture of a target tissue site on the left atrial wall. The curved puncture portion 120 may include a shape memory material such that the curved puncture portion 120 can assume a curved configuration after it is released from the lumen of the delivery catheter. In some embodiments, the curved puncture portion 120 may include a circular segment. For example, the curved puncture portion 120 may include a semicircle. Reference Figure 3 The curved puncture portion 120 may be oriented proximally. For example, the inner edge of the curved puncture portion 120 may include at least a portion oriented proximally, such that at least a portion of the recessed portion of the curved puncture portion 120 is oriented proximally. In some embodiments, the puncture tip 180 may be proximally oriented. In some embodiments, the puncture tip 180 may be laterally oriented.

[0070] refer to Figure 3 The anchoring portion 170 may include a first anchoring portion 130 and a second anchoring portion 140. The first anchoring portion 130 may include a first end 132 and a second end 134. The first end 132 of the first anchoring portion 130 may be coupled to the second end 124 of the curved puncture portion 120. For example, the first end 132 of the first anchoring portion 130 may meet the second end 124 of the curved puncture portion 120 at a first bend 126. The first bend 126 may be oriented distally or substantially distally. In some embodiments, at least a portion of the recessed portion of the first bend 126 is oriented distally. For example, the first bend 126 may include an acute angle, wherein the acute angle is oriented distally or substantially distally.

[0071] The first anchoring portion 130 and the second anchoring portion 140 may meet at the second bend 136. The second anchoring portion 140 may include a first end 142, and the first end 142 of the second anchoring portion 140 may be coupled to a second end 134 of the first anchoring portion 130. The first end 142 of the second anchoring portion 140 and the second end 134 of the first anchoring portion 130 may meet at the second bend 136. The second bend 136 may be oriented proximally or substantially proximally. In some embodiments, at least a portion of the recessed portion of the second bend 136 is oriented proximally. For example, the second bend 136 may include an acute angle, and the acute angle may be oriented proximally or substantially proximally. In some embodiments, the first bend 126 and the second bend 136 may include opposite or substantially opposite orientations. In some embodiments, the first bend 126 and the second bend 136 may each include an acute angle, and the acute angle may include opposite or substantially opposite orientations. The second anchoring portion 140 may extend proximally from the first end 142.

[0072] In some embodiments, the first anchoring portion 130 and the second anchoring portion 140 may each include a straight or substantially straight portion. As described herein, the first bend 126 and the second bend 136 may each include an acute angle and have opposite or substantially opposite orientations. The curved puncture portion 120 and the anchoring portion 170 together may include a serrated shape. In some embodiments, the first anchoring portion 130 and the second anchoring portion 140 may each be a straight or substantially straight portion, such that the curved puncture portion 120 and the anchoring portion 170 together may include a “z” shape. In some embodiments, the first anchoring portion 130 and the second anchoring portion 140 may be flexible, such that the first anchoring portion 130 and the second anchoring portion 140 may have a curved configuration to conform to the curvature of the container, channel, chamber, and / or organ in which the anchoring portion 170 is positioned. In some embodiments, the flexibility of the first anchoring portion 130 and the second anchoring portion 140 may facilitate the advancement of the puncture needle 100 through a tortuous anatomical path.

[0073] In some embodiments, the curved puncture portion 120 and the anchoring portion 170 may be in the same plane and / or a parallel plane. The curved puncture portion 120 and the anchoring portion 170 may be laid flat or substantially flat when placed on their side. For example, the curved puncture portion 120, the first anchoring portion 130, and the second anchoring portion 140 may all extend along a line contained in the same plane. In some embodiments, the curved puncture portion 120, the first anchoring portion 130, the second anchoring portion 140, and the puncture tip 180 may all be in the same plane. In some embodiments, the curved puncture portion 120 and the anchoring portion 170 may include corresponding portions in the same plane. For example, corresponding portions of the curved puncture portion 120, the first anchoring portion 130, and the second anchoring portion 140 may extend along a line contained in the same plane, such that the curved puncture portion 120, the first anchoring portion 130, and the second anchoring portion 140 each include a portion extending along a line contained in a parallel plane.

[0074] In some embodiments, the curved puncture portion 120 may include a transverse section comprising a circle, including a circular or substantially circular shape. Alternatively, the transverse section may include a non-circular shape, including a polygonal shape, such as a rectangular or substantially rectangular shape. A non-circular cross-sectional shape may provide a reduced profile for the puncture needle 100. The transverse section of the curved puncture portion 120 may be cut along a plane perpendicular to or substantially perpendicular to the concavity of the curvature. In some embodiments, the anchoring portion 170 may include a transverse section comprising a circle, including a circular shape. Alternatively, the transverse section may include a non-circular shape, including a polygonal shape (e.g., a rectangular or substantially rectangular shape), for example to provide a reduced profile for the puncture needle 100. In some embodiments, a portion of the transverse section of the anchoring portion 170 may be cut along a plane perpendicular to or substantially perpendicular to the longitudinal axis of the puncture needle 100 and / or the longitudinal axis of a portion of the anchoring portion 170.

[0075] In some embodiments, the curved puncture portion 120 and the anchoring portion 170 may be integrally formed. In some embodiments, the curved puncture portion 120 and the anchoring portion 170 may be part of a single elongated portion. For example, the distal portion 112 of the elongated portion 110 may include the curved puncture portion 120, the first anchoring portion 130, and the second anchoring portion 140. The first anchoring portion 130 may be a first distal elongated portion. The second anchoring portion 140 may be a second distal elongated portion. As described herein, the curved puncture portion 120 may have a puncture tip 180 associated with a first end 122. The curved puncture portion 120 may extend from the first end 122 to a first bend 126. The first bend 126 may have a first acute angle oriented distally. The first distal elongated portion or the first anchoring portion 130 may intersect with the curved puncture portion 120 at the first bend 126. The first distal elongated portion may extend from the first bend 126 to the second bend 136. The second bend 136 may have a second acute angle oriented proximally. The first distal elongated portion may intersect with the second distal elongated portion or the second anchoring portion 140 at the second bend 136. The second distal elongated portion may extend proximally from the second bend 136. The second bend 136 may be distal to the bend puncture portion 120.

[0076] In some embodiments, the first bend 126 and the second bend 136 may each include a sharp and / or pointed bend. In some embodiments, the sharp and / or pointed bend may facilitate a reduced profile of the distal portion 102 of the puncture needle 100.

[0077] As described herein, the anchoring portion 170 may include at least a portion distal to the curved puncture portion 120. A portion of the first anchoring portion 130 and a portion of the second anchoring portion 140 may be distal to the curved puncture portion 120. For example, a second bend 136 may be distal to the curved puncture portion 120. In some embodiments, the portion of the anchoring portion 170 distal to the curved puncture portion 120 may engage with one or more portions of the lumen wall of the delivery catheter to facilitate maintaining the desired orientation of the curved puncture portion 120. The puncture needle 100 may be preloaded within the lumen of the delivery catheter, for example, the curved puncture portion 120 and the anchoring portion 170 may be positioned near or adjacent to a side outlet opening configured to allow the puncture needle 100 to extend through it.

[0078] As described in further detail herein, the anchoring portion 170 may include a portion configured to be received in the lumen of the delivery catheter in both the retracted and extended states of the puncture needle 100, the delivery catheter lumen being distal to the lateral outlet opening. Engaging and / or interacting with portions of the lumen wall distal to the lateral outlet opening (e.g., rather than with any portions of the lumen wall proximal to the lateral outlet opening) of the anchoring portion 170 may facilitate the stabilization of the axial orientation of the anchoring portion 170, thereby facilitating the stabilization of the axial orientation of the curved puncture portion 120. The desired axial orientation of the curved puncture portion 120 may be maintained or substantially maintained regardless of torsional forces applied to the puncture needle 100 and / or any rotation of the proximal portion of the puncture needle 100 as the delivery catheter is advanced through a tortuous anatomical path. Engaging the anchoring portion 170 with portions of the lumen wall of the delivery catheter distal to the lateral outlet opening may disengage any axial rotation of the proximal portion of the puncture needle 100 from the curved puncture portion 120, thereby allowing the curved puncture portion 120 to remain aligned relative to the delivery catheter. In some embodiments, when the puncture needle 100 is positioned within the lumen of the delivery catheter and when the delivery catheter is advanced to the target tissue site via a tortuous anatomical path, the curved puncture portion 120 may not exhibit rotation about the longitudinal axis of the puncture needle 100 or may exhibit reduced rotation.

[0079] In some embodiments, both the curved puncture portion 120 and the anchoring portion 170 can engage with corresponding portions of the lumen wall of the delivery catheter to prevent or reduce axial rotation of the curved puncture portion 120. For example, the bends 126, 136 in the distal portion 102 can give the curved puncture portion 120 and the anchoring portion 170 a radially extending tendency. For example, the curved puncture portion 120 and the anchoring portion 170 can be spring-loaded. The radially extending tendency can increase the 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 facilitate the fixation of the position and / or orientation of the curved puncture portion 120, reducing or preventing rotation of the curved puncture portion 120. In some embodiments, the radially extending tendency of the anchoring portion 170 and the curved puncture portion 120 can facilitate the extension of the curved puncture portion 120 through the side outlet opening when the puncture needle 100 is deployed.

[0080] Figure 4 An example of a puncture needle 200 is shown. The distal portion 202 of the puncture needle 200 may include a plurality of bends, each bend potentially having a circular configuration. The distal portion 202 of the puncture needle 200 may include a curved puncture portion 220 and an anchoring portion 270. The anchoring portion 270 may include at least a portion extending distally to the curved puncture portion 220. In some embodiments, the puncture needle 200 may include an elongated portion 210, and the distal portion 212 of the elongated portion 210 may include the curved puncture portion 220 and the anchoring portion 270.

[0081] refer to Figure 4 The curved puncture portion 220 may include a first end 222 associated with the puncture tip 280 and a second end 224 coupled to the anchoring portion 270. The curved puncture portion 220 may include a reference Figure 3 One or more features of the described curved puncture portion 120. For example, the curved puncture portion 220 may include a circular segment, such as a semicircle. In some embodiments, the curved puncture portion 220 may be oriented proximally. In some embodiments, the puncture tip 280 may be pointed proximally. In some embodiments, the puncture tip 280 may be pointed laterally.

[0082] The anchoring portion 270 may include a first anchoring portion 230 and a second anchoring portion 240. The first anchoring portion 230 includes a first end 232 and a second end 234, and the second anchoring portion 240 includes a first end 242. The first end 232 of the first anchoring portion 230 may be coupled to the second end 224 of the curved puncture portion 220. For example, the first end 232 of the first anchoring portion 230 may meet the second end 224 of the curved puncture portion 220 at a first bend 226. Figure 4 As shown, the first bend 226 may be oriented distally or substantially distally. For example, the recessed portion of the first bend 226 may ultimately include a portion oriented distally or substantially distally. The first anchoring portion 230 and the second anchoring portion 240 may meet at the second bend 236. A first end 242 of the second anchoring portion 240 may be coupled to a second end 234 of the first anchoring portion 230. The first end 242 of the second anchoring portion 240 and the second end 234 of the first anchoring portion 230 may meet at the second bend 236. In some embodiments, the first bend 226 and the second bend 236 may include opposite or substantially opposite orientations. The second bend 236 may be oriented proximally or substantially proximally. For example, the recessed portion of the second bend 236 may ultimately include a portion oriented proximally or substantially proximally. The second anchoring portion 240 may extend proximally from the second bend 236.

[0083] In some embodiments, one or both of the first bend 226 and the second bend 236 may be circular, for example, including an arcuate shape. One or both of the first bend 226 and the second bend 236 may include a circular or elliptical segment. In some embodiments, both the first bend 226 and the second bend 236 may be circular, for example, including a circular segment. In some embodiments, when in a relaxed state (e.g., when the puncture needle 200 is not within the lumen of the delivery catheter), the first anchoring portion 230 and the second anchoring portion 240 may be parallel or substantially parallel to each other. In some embodiments, the second bend 236 may include a semicircle. In some embodiments, the first bend 226 may include a semicircle. In some embodiments, the first anchoring portion 230 and the second anchoring portion 240 are not parallel to each other. In some embodiments, the second bend 236 may include an acute angle. This acute angle may be oriented proximally or substantially proximally; for example, the recessed portion of the second bend 236 may be oriented proximally or substantially proximally.

[0084] The first bend 226 and the second bend 236 may each be sized such that opposite portions of each of the first bend 226 and the second bend 236 can contact opposite portions of the lumen wall of the delivery catheter. In some embodiments, the contact between the bends 226, 236 and the lumen wall of the delivery catheter may reduce or prevent axial rotation of the distal portion 202 of the puncture needle 200, thereby maintaining the desired orientation of the bend puncture portion 220.

[0085] In some embodiments, engagement of the anchoring portion 270 and the delivery catheter lumen wall can prevent or reduce axial rotation of the curved puncture portion 220. When the puncture needle 200 is in the retracted and extended states, a portion of the anchoring portion 270 distal to the curved puncture portion 220 can be received in the portion of the delivery catheter lumen distal to the side outlet opening of the delivery catheter. A portion of the first anchoring portion 230 and a portion of the second anchoring portion 240 may be distal to the curved puncture portion 220. For example, a second bend 236 may be distal to the curved puncture portion 220. In some embodiments, the portion of the anchoring portion 270 distal to the curved puncture portion 220 may engage with one or more portions of the delivery catheter lumen wall distal to the side outlet opening to facilitate maintaining the desired orientation of the curved puncture portion 220. In some embodiments, both the curved puncture portion 220 and the anchoring portion 270 may engage with corresponding portions of the delivery catheter lumen wall to prevent or reduce axial rotation of the curved puncture portion 220.

[0086] The puncture needle 200 may include a reference. Figure 3One or more other features of the described puncture needle 100. For example, the first anchoring portion 230 and the second anchoring portion 240 may each include a straight or substantially straight portion. The first anchoring portion 230 and the second anchoring portion 240 may each be a straight or substantially straight portion. In some embodiments, the curved puncture portion 220 and the anchoring portion 270 may together form a serrated shape, including, for example, a “z” shape. In some embodiments, the first anchoring portion 230 and the second anchoring portion 240 may be flexible, such that the anchoring portions 230, 240 may have a curved configuration to conform to the curvature of the blood vessel, channel, chamber, and / or organ in which the anchoring portion 270 is positioned. The flexibility of the first anchoring portion 230 and the second anchoring portion 240 may facilitate the advancement of the puncture needle 200 through a tortuous anatomical path.

[0087] In some embodiments, the curved puncture portion 220 and the anchoring portion 270 may extend in the same plane and / or parallel planes, for example, along a line in the same plane and / or parallel planes. In some embodiments, the curved puncture portion 220, the first anchoring portion 230, the second anchoring portion 240, the first bend 226, the second bend 236, and the puncture tip 280 may all be in the same plane. The curved puncture portion 220 and the anchoring portion 270 may lie flat or substantially flat when placed on their side. In some embodiments, the curved puncture portion 220 and the anchoring portion 270 may include corresponding portions in the same plane. For example, the corresponding portions of the puncture tip 280, the curved puncture portion 220, the first anchoring portion 230, the first bend 226, the second anchoring portion 240, and the second bend 236 may extend along a line contained in the same plane, such that each of the puncture tip 280, the curved puncture portion 220, the first anchoring portion 230, the first bend 226, the second anchoring portion 240, and the second bend 236 includes a portion extending along a line contained in a parallel plane.

[0088] In some embodiments, the curved puncture portion 220 and the anchoring portion 270 may be integrally formed. In some embodiments, the curved puncture portion 220 and the anchoring portion 270 may be part of a single elongated portion. For example, the distal portion 212 of the elongated portion 210 may include the curved puncture portion 220, the first bend 226, the first anchoring portion 230, the second bend 236, and the second anchoring portion 240. The transverse section of the curved puncture portion 220, the first bend 226, the first anchoring portion 230, the second bend 236, and the second anchoring portion 240 may include a transverse section that is circular, including a circular shape. Alternatively, the transverse section may include a non-circular shape, including a polygonal shape, such as a rectangular shape. In some embodiments, the transverse sections of the curved puncture portion 220, the first bend 226, and the second bend 236 may be cut along a plane perpendicular to or substantially perpendicular to the concavity of the respective concave surface. In some embodiments, the transverse sections of the first anchoring portion 230 and the second anchoring portion 240 may be cut along a plane that is perpendicular to or substantially perpendicular to the longitudinal axis of the anchoring portion 270 and / or the corresponding portion of the puncture needle 200.

[0089] Figure 5 An example of a puncture needle 300 is shown, including an anchoring portion 370, which comprises a first curved anchoring portion 330 and a second curved anchoring portion 340. The first curved anchoring portion 330 and the second curved anchoring portion 340 may each include a pre-formed curvature. The distal portion 302 of the puncture needle 300 may include a curved puncture portion 320 and an anchoring 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 anchoring portion 370.

[0090] The curved puncture portion 320 may include a reference Figure 3 One or more features of the described curved puncture portion 120. The curved puncture portion 320 may include a first end 322 associated with the puncture tip 380 and a second end 324 coupled to the anchoring portion 370. The curved puncture portion 320 may include a circular segment, such as a semicircle. In some embodiments, the curved puncture portion 320 may be oriented proximally. In some embodiments, the puncture tip 380 may be pointed proximally. In some embodiments, the puncture tip 380 may be pointed laterally.

[0091] The first curved anchoring portion 330 and the second curved anchoring portion 340 may include the same orientation. In some embodiments, the first curved anchoring portion 330 and the second curved anchoring portion 340 may include the same orientation as the curved puncture portion 320. For example, the respective recessed portions of the first curved anchoring portion 330 and the second curved anchoring portion 340 may include at least a portion oriented proximally or substantially proximally. The radius of curvature of each of the first curved anchoring portion 330 and the second curved anchoring portion 340 may be selected based at least on the shape of the desired blood vessel, channel, chamber, and / or organ into which the puncture needle 300 is advanced for access to the target tissue site. For example, the radius of curvature of the first curved anchoring portion 330 and the second curved anchoring portion 340 may be selected based on the radius of curvature of the coronary sinus portion into which the anchoring portion 370 is advanced. The anchoring portion 370 may be shaped to follow the curvature length of the coronary sinus. In some embodiments, the radius of curvature of each of the first curved anchoring portion 330 and the second curved anchoring portion 340 may be greater than the radius of curvature of the curved puncture portion 320. For example, the curvature degree of the curved puncture portion 320 may be greater than the curvature degree of the curved anchoring portions 330 and 340, respectively.

[0092] A curved puncture portion 320 may be coupled to a first curved anchoring portion 330 at a first bend 326. A first end 332 of the first anchoring portion 330 may meet a second end 324 of the curved puncture portion 320 at the first bend 326. The first bend 326 may be oriented distally or substantially distally. The first curved anchoring portion 330 may be coupled to a second curved anchoring portion 340 at a second bend 336. A first end 342 of the second anchoring portion 340 may meet a second end 334 of the first anchoring portion 330 at the second bend 336. In some embodiments, the first bend 326 and the second bend 336 may include opposite or substantially opposite orientations. The second bend 336 may be oriented proximally or substantially proximally. In some embodiments, the first bend 326 may include an acute angle, wherein the acute angle is oriented distally or substantially distally. In some embodiments, the second bend 336 may include an acute angle, and the acute angle may be oriented proximally or substantially proximally. The second anchoring portion 340 may extend proximally from the second bend 336. In some embodiments, the first bend 326 and the second bend 336 may each include an acute angle, such that the bend piercing portion 320 and the anchoring portion 370 may include a serrated shape.

[0093] A portion of the anchoring portion 370 may be distal to the curved puncture portion 320. For example, a portion of the first anchoring portion 330 and a portion of the second anchoring portion 340 may be distal to the curved puncture portion 320. A second bend 336 may be distal to the curved puncture portion 320. In some embodiments, the portion of the anchoring portion 370 distal to the curved puncture portion 320 may engage with the lumen wall of the delivery catheter distal to the side outlet opening to prevent or reduce axial rotation of the curved puncture portion 320. In some embodiments, both the curved puncture portion 320 and the anchoring portion 370 may engage with corresponding portions of the lumen wall of the delivery catheter to prevent or reduce axial rotation of the curved puncture portion 320.

[0094] In some embodiments, the transverse cross-section of the curved puncture portion 320 and / or the anchoring portion 370 may be non-circular. The transverse cross-section may be cut along a plane perpendicular to or substantially perpendicular to the concave surface of the respective portion of the curved puncture portion 320 and / or the anchoring portion 370. The transverse cross-section may be selected to reduce the profile of the puncture needle 300. In some embodiments, the transverse cross-section may include a polygonal shape, such as a rectangular or substantially rectangular shape. In some embodiments, as further described in detail herein, the transverse cross-section of the anchoring portion 370 may be selected to correspond to the transverse cross-section of the portion of the delivery catheter lumen distal to the lateral outlet opening to facilitate engagement of the anchoring portion 370 with the lumen wall. Improved engagement between the anchoring portion 370 and the lumen wall facilitates maintaining the desired orientation of the curved puncture portion 320. The concave surface of the curved puncture portion 320 and / or the anchoring portion 370 may generally be orthogonal to the elongated plane of its rectangular cross-section, such as... Figure 5 As shown. Alternatively, the transverse cross-section of the curved puncture portion 320 and / or the anchoring portion 370 may include a circle, for example, a circular shape.

[0095] In some embodiments, the curved puncture portion 320 and the anchoring portion 370 may extend in the same plane and / or parallel plane, for example, along a line in the same plane and / or parallel plane. In some embodiments, the curved puncture portion 320, the first anchoring portion 330, the second anchoring portion 340, and the puncture tip 380 may all be in the same plane. The curved puncture portion 320 and the anchoring portion 370 may lie flat or substantially flat when placed on their side. In some embodiments, the curved puncture portion 320 and the anchoring portion 370 may include corresponding portions in the same plane. For example, corresponding portions of the curved puncture portion 320, the first anchoring portion 330, the second anchoring portion 340, and the puncture tip 380 may extend along a line contained in the same plane, such that the curved puncture portion 320, the first anchoring portion 330, the second anchoring portion 340, and the puncture tip 380 each include a portion extending along a line contained in a parallel plane. In some embodiments, the curved puncture portion 320 and the anchoring portion 370 may be integrally formed, for example, as part of a single elongated portion. For example, the distal portion 312 of the elongated portion 310 may include a curved puncture portion 320, a first anchoring portion 330, and a second anchoring portion 340. The first anchoring portion 330 may be a first distal curved portion, and the second anchoring portion 340 may be a second distal curved portion.

[0096] Figure 6An example of a puncture needle 400 including an anchoring portion 470 is shown. The anchoring portion 470 includes a first anchoring portion 430, a second anchoring portion 440, a third anchoring portion 450, and a fourth anchoring portion 460. A distal portion 402 of the puncture needle 400 (e.g., a distal portion 412 of an elongated portion 410 of the puncture needle 400) may include the anchoring portion 470. The anchoring portion 470 may be coupled to a curved puncture portion 420. The curved puncture portion 420 may intersect with the first anchoring portion 430 at a first bend 426. For example, a first end 432 of the first anchoring portion 430 may be coupled to a second end 424 of the curved puncture portion 420 at the first bend 426. The first bend 426 may be oriented distally or substantially distally. The first anchoring portion 430 may intersect with the second anchoring portion 440 at a second bend 436. The second end 434 of the first anchoring portion 430 may be coupled to the first end 442 of the second anchoring portion 440 at the second bend 436. The second bend 436 may be oriented proximally or substantially proximally. The second anchoring portion 440 may intersect with the third anchoring portion 450 at the third bend 446. For example, the second end 444 of the second bend anchoring portion 440 may be coupled to the first end 452 of the third bend anchoring portion 450 at the third bend 446. The third bend 446 may be oriented distally or substantially distally. The third anchoring portion 450 may intersect with the fourth anchoring portion 460 at the fourth bend 456. The second end 454 of the third bend anchoring portion 450 may be coupled to the first end 462 of the third bend anchoring portion 460 at the fourth bend 456. In some embodiments, the fourth bend 456 may be oriented proximally or substantially proximally. The fourth anchoring portion 460 may extend proximally from the fourth bend 456.

[0097] In some embodiments, each of the first bend 426, the second bend 436, the third bend 446, and the fourth bend 456 may each include an acute angle. In some embodiments, adjacent bends may have opposite or substantially opposite orientations. For example, the first bend 426 may include an acute angle oriented distally or substantially distally. The second bend 436 may include an acute angle oriented proximally or substantially proximally. The third bend 446 may include an acute angle oriented distally or substantially distally. The fourth bend 456 may include an acute angle oriented proximally or substantially proximally. In some embodiments, each of the first anchoring portion 430, the second anchoring portion 440, the third anchoring portion 450, and the fourth anchoring portion 460 may include a straight or substantially straight portion. For example, each of the first anchoring portion 430, the second anchoring portion 440, the third anchoring portion 450, and the fourth anchoring portion 460 may be straight or substantially straight, such that the anchoring portion 470 includes a serrated shape. In some embodiments, the first anchoring portion 430, the second anchoring portion 440, the third anchoring portion 450, and the fourth anchoring portion 460 may be flexible, such that the anchoring portions 430, 440, 450, and 460 may have a curved configuration to conform to the curvature of the vessel, channel, chamber, and / or organ in which the anchoring portion 470 is positioned. Alternatively, in some embodiments, each of the anchoring portions 430, 440, 450, and 460 may include a pre-formed curvature to conform to the curvature of the vessel, channel, chamber, and / or organ. In some embodiments, the anchoring portions 430, 440, 450, and 460 may have a curved configuration and / or a pre-formed curvature to facilitate the advancement of the puncture needle 400 through a tortuous anatomical path.

[0098] A portion of the anchoring portion 470 may be distal to the curved puncture portion 420. For example, at least a portion of each of the first anchoring portion 430, the second anchoring portion 440, the third anchoring portion 450, and the fourth anchoring portion 460 may be distal to the curved puncture portion 420. The second bend 436 and the fourth bend 456 may be distal to the curved puncture portion 420. The portion of the anchoring portion 470 distal to the curved puncture portion 420 may engage with the lumen wall of the delivery catheter distal to the side outlet opening. In some embodiments, both the curved puncture portion 420 and the anchoring portion 470 may engage with corresponding portions of the lumen wall of the delivery catheter to prevent or reduce axial rotation of the curved puncture portion 420.

[0099] Figure 6A second bend 436 is shown distal to the fourth bend 456. In some embodiments, the second bend 436 may 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 may facilitate improved engagement with the lumen wall of the delivery catheter distal to the lateral outlet opening, while maintaining a reduced distal profile of the puncture needle 400. In some embodiments, the second bend 436 and the third and fourth bends 456 may be located at similar or identical distal positions.

[0100] The curved puncture portion 420 may include a reference Figure 3 One or more features of the described curved puncture portion 120. The curved puncture portion 420 may include a first end 422 associated with the puncture tip 480. A second end 424 may be coupled to the anchoring portion 470. In some embodiments, the curved puncture portion 420 may include a circular segment, such as a semicircle. The curved puncture portion 420 may be oriented proximally or substantially proximally. In some embodiments, the puncture tip 480 may be pointed proximally. In some embodiments, the puncture tip 480 may be laterally pointed. In some embodiments, the curved puncture portion 420 and the anchoring portion 470 may be integrally formed, for example, as part of a single elongated portion.

[0101] Figure 7 An example of a puncture needle 500 is shown, which includes a curved puncture portion 520 oriented distally or substantially distally. The distal portion 502 of the puncture needle 500 may include the curved puncture portion 520 and an anchoring portion 570. The anchoring portion 570 may be coupled to the curved puncture portion 520. For example, the distal portion 512 of the elongated portion 510 of the puncture needle 500 may include the anchoring portion 570 and the curved puncture portion 520. A recessed portion of the curved puncture portion 520 may include at least a portion oriented distally or substantially distally. In some embodiments, the puncture tip 580 may be distally pointed. In some embodiments, the puncture tip 580 may be laterally pointed. The curved puncture portion 520 may include a reference... Figure 3 One or more other features of the described curved puncture portion 120. For example, the curved puncture portion 520 may include a first end 522 associated with the puncture tip 580 and a second end 524 coupled to the anchoring portion 570. In some embodiments, the curved puncture portion 520 may include a circular segment, such as a semicircle.

[0102] The puncture needle 500 may include reference Figure 6One or more other features of the described puncture needle 400. In some embodiments, the puncture needle 500 may include other features of the puncture needle 400. For example, the anchoring portion 570 may include a first anchoring portion 530, a second anchoring portion 540, a third anchoring portion 550, and a fourth anchoring portion 560. A first end 532 of the first anchoring portion 530 may be coupled to a second end 524 of the curved puncture portion 520. A second end 534 of the first anchoring portion 530 may be coupled to a first end 542 of the second anchoring portion 540 at a first bend 536. The first bend 536 may be oriented proximally or substantially proximally. A second end 544 of the second curved anchoring portion 540 may be coupled to a first end 552 of the third curved anchoring portion 550 at a second bend 546. The second bend 546 may be oriented distally or substantially distally. A second end 554 of the third curved anchoring portion 550 may be coupled to a first end 562 of the third curved anchoring portion 560 at a third bend 556. The third bend 556 may be oriented proximally or substantially proximally. The fourth anchoring portion 560 may extend proximally from the third bend 556.

[0103] In some embodiments, each of the first bend 536, the second bend 546, and the third bend 556 may include an acute angle. The first bend 536 may include an acute angle oriented proximally or substantially proximally. The second bend 546 may include an acute angle oriented distally or substantially distally. The third bend 556 may include an acute angle oriented proximally or substantially proximally. The first bend 536 may be distally, proximally, or at the same or similar distal location as the third bend 556. In some embodiments, each of the first anchoring portion 530, the second anchoring portion 540, the third anchoring portion 550, and the fourth anchoring portion 560 may include a straight or substantially straight portion. For example, each of the first anchoring portion 530, the second anchoring portion 540, the third anchoring portion 550, and the fourth anchoring portion 560 may be straight or substantially straight, such that the anchoring portion 570 includes a serrated shape. In some embodiments, the anchoring portions 530, 540, 550, and 560 may be flexible, such that they may have a curved configuration to conform to the curvature of the vessel, channel, chamber, and / or organ in which the anchoring portion 570 is positioned. Alternatively, in some embodiments, each of the anchoring portions 530, 540, 550, and 560 may include a pre-formed curvature to conform to the curvature of the vessel, channel, chamber, and / or organ. In some embodiments, the anchoring portions 530, 540, 550, and 560 may have a curved configuration and / or a pre-formed curvature to facilitate the advancement of the puncture needle 500 through a tortuous anatomical path.

[0104] refer to Figure 6 and Figure 7 The described puncture needles 400 and 500 can be used as a reference. Figure 3 One or more other features of the described puncture needle 100. For example, see reference. Figure 6 and Figure 7 The described curved puncture portions 420, 520 and the anchoring portions 470, 570 of the puncture needles 400, 500 may extend in the same plane and / or parallel plane, for example, along a line in the same plane and / or parallel plane. In some embodiments, the curved puncture portion 520, the anchoring portion 570, and the puncture tip 580 may all be in the same plane. The curved puncture portions 420, 520, and the anchoring portions 470, 570 may include corresponding portions in the same plane. The corresponding portions of the curved puncture portions 420, 520, and the anchoring portions 470, 570 may extend along a line contained in the same plane, such that the curved puncture portions 420, 520, and the anchoring portions 470, 570 each include a portion extending along a line contained in a parallel plane. In some embodiments, the curved puncture portion 520 and the anchoring portion 570 may be integrally formed, for example, as part of a single elongated portion.

[0105] refer to Figure 6 and Figure 7 The transverse sections of the described puncture needles 400 and 500 may each include a circle (e.g., a circular shape), or alternatively, a non-circular shape, such as a polygon. For example, each of the curved puncture portions 420 and 520 and the anchoring portions 470 and 570 may include a transverse section comprising a circle, including a circular shape. Alternatively, the transverse section may include a rectangular shape. The transverse sections of the curved puncture portions 420 and 520 may be taken along a plane perpendicular to or substantially perpendicular to the respective concave surface of the curved puncture portions 420 and 520. The transverse sections of the anchoring portions 470 and 570 may be taken along a plane perpendicular to or substantially perpendicular to the longitudinal axis of the respective puncture needles 400 and 500 and / or the respective anchoring portion.

[0106] Although reference Figure 6 and Figure 7 The described puncture needles 400 and 500 each include anchoring portions 470 and 570, which comprise four distinct sections, but it should be understood that anchoring portions may include more distinct sections. For example, an anchoring portion may include six distinct anchoring portions. In some embodiments, increasing the number of distinct anchoring portions may further decouple the orientation of the curved puncture portion from any rotation of the proximal portion of the puncture needle. In some embodiments, different numbers of anchoring portions may be selected to provide desired stability in the axial orientation of the curved puncture portion while providing a low-profile puncture needle.

[0107] Figure 8A and Figure 8BA puncture needle system 800 is shown. The puncture needle system 800 may include a reference Figure 3 The described puncture needle 100 and delivery catheter 802 configured to receive the puncture needle 100. Figure 8A and Figure 8B The image shows a side cross-sectional view along the longitudinal axis of the delivery catheter 802. The puncture needle 100 can be preloaded into the delivery catheter 802. For example, the puncture needle 100 can be positioned within the delivery catheter 802 before the puncture needle system 800 is positioned at the target location to reach the target tissue site (e.g., before the puncture needle system 800 is inserted into the patient). Figure 8A The puncture needle 100 is shown preloaded in the delivery catheter 802 and in a retracted state. Figure 8B The puncture needle 100 is shown in its deployed state. (Reference) Figure 8A The delivery catheter 802 may include a puncture needle lumen 804 configured to receive a puncture needle 100. The distal portion 806 of the delivery catheter 802 may include a side outlet opening 808 configured to allow the puncture needle 100 to extend through it to reach a target tissue site. In some embodiments, the delivery catheter 802 may include a guidewire lumen 810 configured to receive a guidewire (not shown). The delivery catheter 802 may be advanced along the guidewire to position the delivery catheter 802 in a desired orientation to reach the target tissue site.

[0108] Insertion of the puncture needle through one or more bends in a tortuous anatomical path may cause undesirable axial rotation of the needle. Undesirable rotation of the needle, positioned within the delivery catheter, may cause misalignment of the needle relative to the lateral outlet opening, thereby hindering the desired unfolding of the needle from the delivery catheter and / or its use in puncturing tissue at the target tissue site. In some embodiments, misalignment of the needle may impede effective tissue puncture.

[0109] Anchoring portion 170 may include a portion positioned within a portion of the puncture needle lumen 804 distal to the side outlet opening 808. In the retracted state, the second bend 136 of the puncture needle 100 may be distal to the side outlet opening 808. For example, a portion of the first anchoring portion 130 and a portion of the second anchoring portion 140 may be received within the portion of the puncture needle lumen 804 distal to the side outlet opening 808. In some embodiments, positioning the portion of anchoring portion 170 distal to the side outlet opening 808 may facilitate maintaining a desired axial orientation of the bend puncture portion 120 within the puncture needle lumen 804. Anchoring portion 170 may engage with the wall of the portion of the puncture needle lumen 804 distal to the side outlet opening 808 to reduce or eliminate unwanted rotation of the bend puncture portion 120 about the longitudinal axis of the puncture needle 100.

[0110] In the retracted state, the first curved portion 126 of the puncture needle 100 can be proximal to the side outlet opening 808. Figure 8A A puncture tip 180 is shown proximal to the side outlet opening 808. In some embodiments, the entirety or substantially the entirety of the curved puncture portion 120 may be proximal to the side outlet opening 808. For example, the puncture tip 180 and the curved puncture portion 120 may be proximal to the side outlet opening 808 and may be received within the puncture needle lumen 804. A first bend 126 may be proximal to the side outlet opening 808. An anchoring portion 170 may extend along the puncture needle lumen 804 through the side outlet opening 808. For example, the anchoring portion 170 may extend along a portion of the puncture needle lumen 804 proximal to the side outlet opening 808, through a portion of the lumen 804 at the side outlet opening 808, and along a portion of the puncture needle lumen 804 distal to the side outlet opening 808.

[0111] In some embodiments, portions of the curved puncture portion 120 and / or the anchoring portion 170 may engage with a portion of the wall of the puncture needle lumen 804 proximal to the side outlet opening 808. The distal portion 102 of the puncture needle 100, including the bends 126, 136, may tend to apply radial force to the curved puncture portion 120 and the anchoring portion 170 to provide a spring-loaded effect. This radially extending tendency may increase contact between the puncture needle 100 and the lumen wall of the delivery catheter 802, thereby facilitating the fixation of the position and / or orientation of the curved puncture portion 120. In some embodiments, the radially extending tendency of the anchoring portion 170 and the curved puncture portion 120 may facilitate the extension of the curved puncture portion 120 through the side outlet opening 808 when the puncture needle 100 is deployed. For example, when the curved puncture portion 120 is aligned with the side outlet opening 808, the radially extending tendency may facilitate the curved puncture portion 120 extending beyond the opening 808 to present its desired curved shape.

[0112] refer to Figure 8B When the puncture needle 100 is in the deployed state, at least a portion of the curved puncture portion 120 can extend through the side outlet opening 808. In some embodiments, such as Figure 8B As shown, only a portion of the curved puncture portion 120 can extend through the side outlet opening 808 in the deployed state. For example, the first bend 126 may be within the puncture needle lumen 804 proximal to the side outlet opening 808. In some embodiments, the entire or substantially the entire curved puncture portion 120 may extend beyond the side outlet 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 extend beyond the side outlet opening 808 in the deployed state. In some embodiments, the first bend 126 may be aligned with the side outlet opening 808.

[0113] The puncture needle 100 can be distally translated relative to the delivery catheter 802 to release at least a portion of the curved puncture portion 120 through the side outlet opening 808. The puncture needle 100 can be pushed to align the curved puncture portion 120 with the side outlet opening 808, such that the puncture tip 180 and at least a portion of the curved puncture portion 120 can extend through the side outlet opening 808. The curved puncture portion 120 may include a shape memory material such that once the curved puncture portion 120 is no longer constrained by the delivery catheter 802, the curved puncture portion 120 can present its desired curved configuration.

[0114] After the opening is formed at the target tissue location, the puncture needle 100 can be translated proximally to retract the curved puncture portion 120 back into the puncture needle lumen 804 through the lateral outlet opening 808. For example, the puncture needle 100 can be pulled relative to the delivery catheter 802 to retract the curved puncture portion 120 back into the lumen 804.

[0115] Alternatively, in some embodiments, when the puncture needle 100 is in the retracted state, at least a portion of the curved puncture portion 120 may be positioned within the portion of the puncture needle lumen 804 distal to the side outlet opening 808. In some embodiments, in the retracted state, the curved puncture portion 120 may be completely or substantially completely distal to the side outlet opening 808. The puncture needle 100 may be translated proximally relative to the delivery catheter 802 to release at least a portion of the curved puncture portion 120 through the side outlet opening 808. The puncture needle 100 may be pulled to align the curved puncture portion 120 with the side outlet opening 808 such that the puncture tip 180 and at least a portion of the curved puncture portion 120 extend through the side outlet opening 808.

[0116] Figure 9A puncture needle system 900 is illustrated, comprising a delivery catheter 902 and a puncture needle 100 received within the delivery catheter 902. The delivery catheter 902 may include a puncture needle lumen configured to receive the puncture needle 100. A distal portion 906 of the delivery catheter 902 may include a side outlet opening 908 configured to allow the puncture needle 100 to extend through it. The distal portion 906 may include a curved portion, for example, to facilitate positioning of the distal portion 906 to a target blood vessel, channel, cavity, and / or organ. In some embodiments, an expandable anchor 910 may be associated with the distal portion 906 of the delivery catheter 902. The expandable anchor 910 may be in an expanded state to facilitate stable positioning of the distal portion 906 in a desired orientation within the target blood vessel, channel, cavity, and / or organ. For example, 910 may be associated with the curved portion of the distal portion 906. In some embodiments, the delivery catheter 902 may include a guidewire lumen extending therethrough and configured to receive a delivery catheter guidewire. The delivery catheter 902 may be advanced along the delivery catheter guidewire to position the delivery catheter 902 in a desired orientation to reach a target tissue site.

[0117] The puncture needle system 900 may include a medical implantable guidewire sheath 950 configured to receive a medical implantable guidewire (not shown). The medical implantable guidewire sheath 950 may include a distal portion 952 configured to be coupled to a curved puncture portion 120 of the puncture needle 100. In some embodiments, the distal portion 952 may be fixedly coupled to the curved puncture portion 120 such that the distal portion 952 is translatable proximally and / or distally together with the curved puncture portion 120. The distal portion 952 of the medical implantable guidewire sheath 950 may extend and / or retract through a side outlet opening 908 together with the curved puncture portion 120 of the puncture needle 100. In some embodiments, the medical implantable guidewire sheath 950 may be coupled to a portion of the curved puncture portion 120. In some embodiments, the medical implantable guidewire sheath 950 may be coupled to the entirety or substantially the entirety of the curved puncture portion 120. The medical implantable guidewire sheath 950 can extend proximally from the curved puncture portion 120, for example, and be received in the lumen of the puncture needle of the delivery catheter 902.

[0118] The medical implantable guidewire sheath 950 may include a distal end 954 coupled to the curved puncture portion 120. The distal end 954 may be proximal to the first end 122 of the curved puncture portion 120. For example, the distal end 954 may be proximal to the puncture tip 180. In some embodiments, the distal end 954 may be located at the first end 122, for example, adjacent to the puncture tip 180. The medical implantable guidewire sheath 950 may include a distal exit opening 956 through which the medical implantable guidewire extends. The distal exit opening 956 may be located at or near the distal end 954.

[0119] After an opening is formed at the target tissue site, a medical implantable guidewire can be advanced through the medical implantable guidewire sheath 950. The distal portion of the medical implantable guidewire can extend through a distal exit opening 956 and into the opening formed at the target tissue site. A puncture needle system 900, including the medical implantable guidewire sheath 950, can retract after the medical implantable guidewire has been positioned through the opening formed at the target tissue site, thereby leaving the medical implantable guidewire in place. The medical implantable device can then be advanced along the medical implantable guidewire to the target tissue site. For example, a shunt device can be advanced along the medical implantable guidewire to an opening formed in the left atrial wall to shunt blood flow from the left atrium to the coronary sinus.

[0120] Figure 10 An example of a puncture needle 1000 is shown, which includes a curved anchoring portion 1030 and a curved puncture portion 1020 oriented proximally or substantially proximally. The distal portion 1002 of the puncture needle 1000 may include the curved puncture portion 1020 and the curved anchoring portion 1030. For example, the curved anchoring portion 1030 may include a pre-formed curvature. The puncture needle 1000 may include an elongated portion 1010, and the distal portion 1012 of the elongated portion 1010 may include the curved puncture portion 1020 and the curved anchoring portion 1030. The curved anchoring portion 1030 may include a portion extending distally to the curved puncture portion 1020. For example, the distal end 1032 of the curved anchoring portion 1030 may be distal to the curved puncture portion 1020. The curved anchoring portion 1030 may include a second end 1034 coupled to the curved puncture portion 1020. The curved puncture portion 1020 may include a first end 1022 associated with the puncture tip 1040 and a second end 1024 coupled to a second end 1034 of the curved anchoring portion 1030. The curved puncture portion 1020 may include a reference Figure 3 One or more features of the described curved puncture portion 120. For example, the curved puncture portion 1020 may include a circular segment, such as a semicircle. In some embodiments, the curved puncture portion 1020 may be oriented proximally. In some embodiments, the puncture tip 1040 may be pointed proximally. In some embodiments, the puncture tip 1040 may be pointed laterally.

[0121] The puncture needle 1000 can be received within the delivery catheter. A distal portion of the delivery catheter may include a side outlet opening through which the puncture needle 1000 can extend, for example, through a curved puncture portion 1020. A portion of the curved anchoring portion 1030 extending distally to the curved puncture portion 1020 can be configured to engage a portion of the delivery catheter lumen distal to the side outlet opening to reduce or eliminate axial rotation of the curved puncture portion 1020.

[0122] The curvature of the curved puncture portion 1020 and the curvature of the curved anchoring portion 1030 can have the same orientation. For example... Figure 10 As shown, both the curved puncture portion 1020 and the curved anchoring portion 1030 can be oriented proximally. For example, the inner edge of the curvature of the curved anchoring portion 1030 may include at least a portion that is oriented proximally.

[0123] In some embodiments, in a relaxed state, the curved puncture portion 1020 may have a radius of curvature smaller than that of the curved anchoring portion 1030. For example, the degree of curvature of the curved puncture portion 1020 may be greater than that of the curved anchoring portion 1030. The radius of curvature of the curved anchoring portion 1030 may be selected based on the curvature of the anatomical path adjacent to or near the target tissue site. For example, as described herein, the puncture needle 1000 may be configured to be inserted into the coronary sinus to puncture tissue on a portion of the left atrial wall accessible from within the coronary sinus. The radius of curvature of the curved anchoring portion 1030 may be selected based on the radius of curvature of the coronary sinus into which the curved anchoring portion 1030 is advanced. For example, the curved anchoring portion 1030 may be shaped to follow the curvature length of the coronary sinus.

[0124] In some embodiments, the curved puncture portion 1020 and the curved anchoring portion 1030 may be in the same plane and / or a parallel plane. For example, the curved puncture portion 1020 and the curved anchoring portion 1030 may extend along a line in the same plane and / or a parallel plane. The curved puncture portion 1020 and the curved anchoring portion 1030 may include corresponding portions in the same plane. The corresponding portions of the curved puncture portion 1020 and the curved anchoring portion 1030 may extend along a line contained in the same plane, such that the curved puncture portion 1020 and the curved anchoring portion 1030 each include a portion extending along a line contained in a parallel plane.

[0125] The transverse sections of the curved puncture portion 1020 and the curved anchoring portion 1030 may include non-circular shapes, such as polygonal shapes, including rectangular shapes. Alternatively, the transverse sections may include circular shapes. The transverse sections of the curved puncture portion 1020 and the curved anchoring portion 1030 may be cut along a plane that is perpendicular to or substantially perpendicular to the respective concave surfaces of the curved puncture portion 1020 and the curved anchoring portion 1030.

[0126] In some embodiments, the curved puncture portion 1020 and the curved anchoring portion 1030 may be integrally formed. For example, the distal portion 1012 of the elongated portion 1010 may include a curved distal elongated portion and a curved puncture portion 1020 extending from the curved distal elongated portion. The curved distal elongated portion may be the curved anchoring portion 1030. The curved puncture portion 1020 may extend from a second end 1034 of the curved distal elongated portion and may extend to the puncture tip 1040.

[0127] Figure 11 An example of a puncture needle 1100 is shown, which includes a curved anchoring portion 1130 and a curved puncture portion 1120 oriented distally or substantially distally. The curved anchoring portion 1120 may include a pre-formed curvature. The inner edge of the curvature of the curved puncture portion 1120 may include at least a distally oriented portion. For example, a recessed portion of the curved puncture portion 1120 may include at least a distally oriented portion. The curved puncture portion 1120 may include a reference... Figure 7 The described curved puncture portion 520 includes one or more features. 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 anchoring portion 1130. The curved anchoring portion 1130 may include the second end 1134 coupled to the curved puncture portion 1120. In some embodiments, the curved puncture portion 1120 may include a circular segment, such as a semicircle. In some embodiments, the puncture tip 1140 may be distally oriented. In some embodiments, the puncture tip 1140 may be laterally oriented.

[0128] The puncture needle 1100 may include reference Figure 10 One or more other features of the described puncture needle 1000. For example, the distal portion 1102 of the puncture needle 1100 may include a curved puncture portion 1120 and a curved anchoring portion 1130. The puncture needle 1100 may include an elongated portion 1110, and the distal portion 1112 of the elongated portion 1110 may include the curved puncture portion 1120 and the curved anchoring portion 1130. The curved anchoring portion 1130 may include a portion extending distally to the curved puncture portion 1120, including a distal end 1132 of the curved anchoring portion 1130. The curved anchoring portion 1130 may be oriented proximally. In some embodiments, the curved puncture portion 1120 may have a radius of curvature smaller than that of the curved anchoring portion 1130.

[0129] In some embodiments, the curved puncture portion 1120 and the anchoring portion 1130 may include at least some portions in the same plane and / or parallel plane. For example, the curved puncture portion 1120 and the curved anchoring portion 1130 may extend along a line in the same plane and / or parallel plane. The curved puncture portion 1120 and the curved anchoring portion 1130 may include corresponding portions in the same plane. The corresponding portions of the curved puncture portion 1120 and the curved anchoring portion 1130 may extend along a line contained in the same plane, such that the curved puncture portion 1120 and the curved anchoring portion 1130 each include a portion extending along a line contained in a parallel plane. In some embodiments, the transverse cross-section of the curved puncture portion 1120 and the curved anchoring portion 1130 may include a non-circular shape, such as a polygonal shape, including a rectangular shape. Alternatively, the transverse cross-section may include a circle, including a circular shape. In some embodiments, the curved puncture portion 1120 and the curved anchoring portion 1130 may be integrally formed. For example, the distal portion 1112 of the elongated portion 1110 may include a curved distal elongated portion and a curved puncture portion 1120 extending from the curved distal elongated portion. The curved distal elongated portion may be a curved anchoring portion 1130.

[0130] Figure 12 An example of a puncture needle 1200 including a distal portion 1202 is shown, the distal portion 1202 including an anchoring portion 1230 and a curved puncture portion 1220, wherein the anchoring portion 1230 and the curved puncture portion 1220 are integrally formed. Figure 12This is a plan view of the puncture needle 1200, showing the curved puncture portion 1220 unfolded in a straight or substantially straight configuration. The curved puncture portion 1220 may include a shape memory material such that the curved puncture portion 1220 can present its desired curved configuration once it is not constrained by the delivery catheter. The curved puncture portion 1220 may include a first end 1222 associated with the puncture tip 1240 and a second end 1224 intersecting with the anchoring portion 1230. The curved puncture portion 1220 and the anchoring portion 1230 may be formed and / or derived from a single material piece 1210. The distal portion 1212 of the material piece 1210 may be divided into two parts to provide the anchoring portion 1230 and the curved puncture portion 1220. For example, the curved puncture portion 1220 may be cut and / or engraved from the distal portion 1212 of the material piece 1210. The bent puncture portion 1220 can be cut and / or engraved from the material part 1210 such that the bent puncture portion 1220 can be released from the remainder of the material part 1210. The remainder of the material part 1210 may include an anchoring portion 1230, for example, extending from position 1234 to a distal end 1232 on the distal portion 1212. In some embodiments, the bent puncture portion 1220 can be laser-cut from the material part 1210. The released bent puncture portion 1220 can extend from position 1234 on the distal portion 1212 of the material part 1210 to a first end 1222 associated with the puncture tip 1240. Figure 12 A surface region 1250 of material 1210 released therefrom is shown from the curved puncture portion 1220. The surface region 1250 may be on the anchoring portion 1230. The anchoring portion 1230 may include a portion extending distally to the curved puncture portion 1220, including a distal end 1232 of the anchoring portion 1230. For example, the portion extending distally to the curved puncture portion 1220 may include the surface region 1250 thereon.

[0131] The curved puncture portion 1220 and the anchoring portion 1230 may include one or more features of the curved puncture portion and anchoring portion as described herein. In some embodiments, the anchoring portion 1230 may be a curved anchoring portion. In some embodiments, the anchoring portion 1230 may include a pre-formed curvature. In some embodiments, both the anchoring portion 1230 and the curved puncture portion 1220 may be oriented proximally. In some embodiments, the curved puncture portion 1220 may have a radius of curvature smaller than the radius of curvature of the curved anchoring portion. In some embodiments, the anchoring portion 1230 may be straight or substantially straight. A straight or substantially straight anchoring portion may be flexible to conform to one or more curvatures of a blood vessel, channel, chamber, and / or organ in which the puncture needle 1200 is positioned.

[0132] In some embodiments, the curved puncture portion 1220 and the anchoring portion 1230 may include at least some portions in the same plane and / or parallel plane, such as portions extending along a line in the same plane and / or parallel plane. In some embodiments, the curved puncture portion 1220 and the anchoring portion 1230 may include corresponding portions in the same plane. For example, the curved puncture portion 1220 and the anchoring portion 1230 may lie flat or substantially flat when placed on their side. The corresponding portions of the curved puncture portion 1220 and the anchoring portion 1230 may extend along a line contained in the same plane, such that the curved puncture portion 1220 and the anchoring portion 1230 each include a corresponding portion extending along a line contained in a parallel plane.

[0133] Figure 13A and Figure 13B A puncture needle system 1300 is shown. The puncture needle system 1300 may include reference... Figure 10 The described puncture needle 1000 and delivery catheter 1302 configured to receive the puncture needle 1000. Figure 13A and Figure 13B The image shows a side cross-sectional view along the longitudinal axis of the delivery conduit 1302. Figure 13A The puncture needle 1000 is shown preloaded in the delivery catheter 1302 and in a retracted state. Figure 13B The puncture needle 1000 is shown in its deployed state. (Reference) Figure 13A The delivery catheter 1302 may include a puncture needle lumen 1304 configured to receive a puncture needle 1000. The distal portion 1306 of the delivery catheter 1302 may include a side outlet opening 1308. The puncture needle 1000 may extend through the side outlet opening 1308 to reach a target tissue site.

[0134] The delivery catheter 1302 may include a guidewire lumen 1310 extending along the 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 may be advanced along the delivery catheter guidewire into a blood vessel, channel, chamber, and / or organ to position the side outlet opening 1308 at or near a target tissue site. In some embodiments, after the delivery catheter has been advanced along the delivery catheter guidewire to the desired orientation within the blood vessel, channel, chamber, and / or organ, the delivery catheter guidewire may be retracted, thereby leaving the delivery catheter in the desired orientation.

[0135] The anchoring portion 1030 may include a portion configured to be positioned within the portion of the puncture needle lumen 1304 distal to the side outlet opening 1308 in both the retracted and deployed states. For example, the distal end 1032 of the anchoring portion 1030 may remain within the portion of the puncture needle lumen 1304 distal to the side outlet opening 1308. The portion of the anchoring portion 1030 distal to the side outlet opening 1308 may engage with the wall of the portion of the puncture needle lumen 1304 distal to the side outlet opening 1308 to reduce or eliminate unwanted rotation of the bent puncture portion 1020 about the longitudinal axis of the puncture needle 1000.

[0136] refer to Figure 13A In the retracted state, the curved puncture portion 1020 can remain or substantially remain within the lumen 1304 of the puncture needle. The second end 1024 of the curved puncture portion 1020 can be proximal to the side outlet opening 1308. Figure 13A A puncture tip 1040 is shown proximal to the side outlet opening 1308. In some embodiments, the entirety or substantially the entirety of the curved puncture portion 1020 may be proximal to the side outlet opening 1308. For example, the puncture tip 1040 and the curved puncture portion 1020 may be proximal to the side outlet opening 1308 and may be received within the puncture needle lumen 1304. A second end 1024 of the curved puncture portion 1020 and a second end 1034 of the anchoring portion 1030 may be proximal to the side outlet opening 1308. The anchoring portion 1030 may extend along the puncture needle lumen 1304 through the side outlet opening 1308. For example, the anchoring portion 1030 may extend along the portion of the puncture needle lumen 1304 proximal to the side outlet opening 1308, through the portion of the lumen 1304 at the side outlet opening 1308, and along the portion of the puncture needle lumen 1304 distal to the side outlet opening 1308.

[0137] In some embodiments, both the curved puncture portion 1020 and the anchoring portion 1030 can engage with corresponding portions of the lumen wall of the delivery catheter to prevent or reduce axial rotation of the curved puncture portion 1020. For example, the curved puncture portion 1020 and the anchoring portion 1030 may have a radially extending tendency. For example, the curved puncture portion 1020 and the anchoring portion 1030 may be spring-loaded. The radially extending tendency can increase the contact between the puncture needle 1000 and the lumen wall of the delivery catheter 1302, facilitating the fixation of the position and / or orientation of the curved puncture portion 1020. In some embodiments, the radially extending tendency of the anchoring portion 1030 and the curved puncture portion 1020 can facilitate the extension of the curved puncture portion 1020 through the side outlet opening 1308 when the puncture needle 1000 is deployed.

[0138] refer to Figure 13BIn the deployed state, at least a portion of the curved puncture portion 1020 may extend through the side outlet opening 1308. In some embodiments, only a portion of the curved puncture portion 1020 extends through the side outlet opening. For example, the second end 1024 may be within the lumen 1304 and proximal to the side outlet opening 1308. Alternatively, the entire or substantially the entire curved puncture portion 1020 may extend beyond the side outlet opening 1308. For example, the second end 1024 of the curved puncture portion 1020 and the second end 1034 of the anchoring portion 1030 may be aligned with the side outlet opening 1308. The entire curved puncture portion 1020 and the puncture tip 1040 may extend through the side outlet opening 1308.

[0139] The puncture needle 1000 can be translated distally relative to the delivery catheter 1302 to release at least a portion of the curved puncture portion 1020 through the side outlet opening 1308, such as releasing the entire or substantially the entire curved puncture portion 1020. The curved puncture portion 1020 may include a shape memory material such that when aligned with the side outlet opening 1308, the curved puncture portion 1020 can extend through the side outlet opening 1308 and present its desired curved configuration. After an opening is formed at the target tissue orientation, the puncture needle 1000 can be translated proximally to retract the curved puncture portion 1020 into the puncture needle lumen 1304 through the side outlet opening 1308. For example, the puncture needle 1000 can be pulled to retract the curved puncture portion 1020 into the lumen 1304.

[0140] Alternatively, in some embodiments, when the puncture needle 1000 is in the retracted state, at least a portion of the curved puncture portion 1020 may be positioned within the portion of the puncture needle lumen 1304 distal to the side outlet opening 1308. For example, the puncture tip 1040 may be distal to the side outlet opening 1308. In some embodiments, in the retracted state, the curved puncture portion 1020 may be completely or substantially completely distal to the side outlet opening 1308. The puncture needle 1000 may be translated proximally relative to the delivery catheter 1302 to release at least a portion of the curved puncture portion 1020 through the side outlet opening 1308. The puncture needle 1000 may be pulled to align the curved puncture portion 1020 with the side outlet opening 1308 such that the puncture tip 1040 and at least a portion of the curved puncture portion 1020 may extend through the side outlet opening 1308.

[0141] Figures 14A to 14DAn example of a puncture needle system 1400 is shown, which includes a delivery catheter 1402 and a puncture needle 1500. The delivery catheter 1402 may include a puncture needle lumen 1404 configured to receive the puncture needle 1500. A distal portion 1406 of the delivery catheter 1402 may include a side outlet opening 1408 configured to allow a portion of the puncture needle 1500 to extend through it to reach a target tissue site and form an opening at the target tissue site. The delivery catheter 1402 may include a guidewire lumen 1410 configured to receive a delivery catheter guidewire (not shown). For example, the guidewire lumen 1410 may extend along the length (e.g., the entire length) of the delivery catheter 1402, allowing the delivery catheter 1402 to be advanced along the delivery catheter guidewire to a desired blood vessel, passage, 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, thereby leaving the delivery catheter 1402 in place.

[0142] Figure 14A A distal portion 1502 of a puncture needle 1500 is shown. The distal portion 1502 may include a curved puncture portion 1520 coupled to an anchoring portion 1530. For example, the distal portion 1512 of an elongated portion 1510 of the puncture needle 1500 may include a curved puncture portion 1520 extending from the anchoring portion 1530. The anchoring portion 1530 may include a distal end 1532 and a second end 1534 coupled to the curved puncture portion 1520. The curved puncture portion 1520 may include a first end 1522 associated with a puncture tip 1540 and a second end 1524 coupled to the second end 1534 of the anchoring portion 1530. The anchoring portion 1530 may include a portion extending distally to the curved puncture portion 1520, including, for example, the distal end 1532 of the anchoring portion 1530.

[0143] In some embodiments, the anchoring portion 1530 may present a straight or substantially straight configuration in a relaxed state. The anchoring portion 1530 may be flexible. For example, the anchoring portion 1530 may be curved to present a curved configuration. The anchoring portion 1530 may present a curved configuration when received within the delivery catheter 1402. For example, the anchoring portion 1530 may present a curved configuration when the delivery catheter 1402 is advanced through a tortuous anatomical path to a desired orientation to reach the target tissue site and / or when the delivery catheter 1402 is positioned at or near a desired orientation. The radius of curvature of the anchoring portion 1530 in the curved configuration may be based on the curvature of the anatomical path adjacent to or near the target tissue site, such as the length of the coronary sinus adjacent to or near the target tissue site on the left atrial wall. The radius of curvature of the curved puncture portion 1520 may be selected to facilitate effective tissue puncture when the puncture needle 1500 is positioned at the desired orientation to reach the target tissue site. For example, the radius of curvature can be predetermined such that when the puncture needle 1500 extends from the side outlet opening 1408, the curved puncture portion 1520 can achieve the desired insertion through the target tissue. In some embodiments, when positioned at or near the target tissue site, the radius of curvature of the anchoring portion 1530 in the curved configuration is greater than the radius of curvature of the curved puncture portion 1520, and the degree of curvature of the curved puncture portion 1520 is greater than the degree of curvature of the anchoring portion 1530. The curvature of the curved puncture portion 1520 and the curvature of the anchoring portion 1530 in the curved configuration when positioned at or near the target tissue site can have the same orientation, for example, proximal orientation. In some embodiments, the puncture tip 1540 can be laterally pointed. In some embodiments, the puncture tip 1540 can be proximal pointed.

[0144] like Figure 14A As shown, the transverse cross-section of the anchoring portion 1530 may have a non-circular shape, such as a polygonal shape. The transverse cross-section may be cut along a plane perpendicular to or substantially perpendicular to the longitudinal axis of the puncture needle 1500. In some embodiments, the transverse cross-section of the anchoring portion 1530 may be rectangular or substantially rectangular. In some embodiments, the transverse cross-section shape may be selected to interlock with the transverse cross-section shape of the delivery catheter lumen 1404, such that the anchoring portion 1530 does not rotate axially or substantially does not rotate axially within the lumen 1404, thereby reducing or eliminating axial rotation of the bent puncture portion 1520. The anchoring portion 1530 may include at least a portion extending distal to the side outlet opening 1408 both when the puncture needle 1500 is in a retracted state and an extended state. For example, the transverse cross-section shape of the lumen 1404 distal to the side outlet opening 1408 may be non-circular in order to interlock with the anchoring portion 1530.

[0145] In some embodiments, the transverse section of the curved puncture portion 1520 may be non-circular. The transverse section may be cut along a plane perpendicular to the concave surface of the curved puncture portion 1520. The transverse section can be selected to reduce the profile of the curved puncture portion 1520, thereby facilitating a reduced profile of the puncture needle 1500. In some embodiments, the transverse section may include a polygonal shape, including rectangular or substantially rectangular shapes. Figure 14A As shown, the concave surface of the curved puncture portion 1520 can typically be orthogonal to its long, flat surface in the form of a rectangular cross-section.

[0146] In some embodiments, the curved puncture portion 1520 and the anchoring portion 1530 may extend in the same plane and / or parallel plane, for example, along a line in the same plane and / or parallel plane. In some embodiments, the curved puncture portion 1520 and the anchoring portion 1530 may extend in the same plane. For example, the curved puncture portion 1520 and the anchoring portion 1530 may lie flat or substantially flat when placed on their side. In some embodiments, corresponding portions of the curved puncture portion 1520 and the anchoring portion 1530 may extend along a line contained in the same plane, such that the curved puncture portion 1520 and the anchoring portion 1530 each include a portion extending along a line contained in a parallel plane. In some embodiments, the curved puncture portion 1520 and the anchoring portion 1530 may be integrally formed, for example, as part of a single elongated portion. For example, the distal portion 1512 of the elongated portion 1510 may include the curved puncture portion 1520 and the anchoring portion 1530.

[0147] Figure 14B This is a transverse cross-sectional view of a portion of the delivery catheter 1402 distal to the side outlet opening 1408. The transverse section may be taken along a plane perpendicular to or substantially perpendicular to the longitudinal axis of the delivery catheter 1402. A guidewire lumen 1410 and a puncture needle lumen 1404 are shown. The guidewire lumen 1410 may include a circular, such as a circular or substantially circular shape. The transverse section of the puncture needle lumen 1404 distal to the side outlet opening 1408 may include a rectangular or substantially rectangular shape.

[0148] Figure 14CThis is a perspective view of a portion of the delivery catheter 1402 including the side outlet opening 1408. The puncture needle system 1400 is shown with the puncture needle 1500 in a retracted state. An anchoring portion 1530 is shown extending within the puncture needle lumen 1404 through the side outlet opening 1408. A second end 1524 of the curved puncture portion 1520 and a second end 1534 of the anchoring portion 1530 may be proximal to the side outlet opening 1408. The anchoring portion 1530 may extend along the portion of the puncture needle lumen 1404 proximal to the side outlet opening 1408, through a portion of the lumen 1404 at the side outlet opening 1408, and along the portion of the puncture needle lumen 1404 distal to the side outlet opening 1408. The anchoring portion 1530 may extend through the portion of the puncture needle lumen 1404 distal to the side outlet opening 1408. The curved puncture portion 1520 may be completely or substantially completely within the portion of the puncture needle lumen 1404 proximal to the side outlet opening 1408. For example, the puncture tip 1540 may be within the lumen 1404 and proximal to the side outlet opening 1408. The puncture needle 1500 may be translated distally (e.g., pushed) to release the curved puncture portion 1520 through the side outlet opening 1408 to unfold the curved puncture portion 1520. In some embodiments, the puncture tip 1540 may be within the lumen 1404 and distal to the side outlet opening 1408. The puncture needle 1500 may be translated proximally (e.g., pulled) to release the curved puncture portion 1520 through the side outlet opening 1408. The curved puncture portion 1520 may include a shape memory material such that once the curved puncture portion 1520 is no longer constrained by the delivery catheter 1402, the curved puncture portion 1520 may present its desired curved configuration.

[0149] Figure 14D A puncture needle system 1400 in an deployed state is shown. The curved puncture portion 1520 is shown extending through a side outlet opening 1408. In some embodiments, the curved puncture portion 1520 may partially extend through the side outlet opening 1408. For example, the second end 1524 of the curved puncture portion 1520 and the second end 1534 of the anchoring portion 1530 may be proximal to the side outlet opening 1408. Because the second end 1534 is within the lumen 1404 of the delivery catheter and proximal to the side outlet opening 1408, the second end 1534 is not... Figure 14D As shown in the diagram. In some embodiments, the entire or substantially the entire curved puncture portion 1520 extends through the side outlet opening. For example, the second end 1524 of the curved puncture portion 1520 and the second end 1534 of the anchoring portion 1530 may be aligned with the side outlet opening 1408. As described herein, when the puncture needle 1500 is in the deployed state, the anchoring portion 1530 may include at least a portion extending distally to the side outlet opening 1408. Figure 14DIn the diagram, the anchoring portion 1530 is shown extending through the lumen 1404 and passing through the side outlet opening 1408.

[0150] Figure 15 This is a flowchart illustrating an example of a procedure 1600 for deploying a puncture needle system for puncturing tissue at a target tissue site. The puncture needle system may include one or more features as described herein. At block 1602, procedure 1600 involves advancing the puncture needle system into a blood vessel. For example, the blood vessel may be the coronary sinus. The puncture needle system may be advanced from the right atrium through the coronary sinus ostium into the coronary sinus. A transjugular or subclavian approach may be used to access the right atrium via the superior vena cava. Alternatively, a transfemoral approach may be used to position the puncture needle system into the inferior vena cava and from there into the right atrium. Procedure 1600 may include a minimally invasive transcatheter approach.

[0151] In some embodiments, the puncture needle system can be delivered into the coronary sinus to access the left atrial wall from within the sinus. The puncture needle system can be used to access target tissue sites on the left atrial wall. The puncture needle system can be used to create an opening in the left atrial wall for delivering one or more medical therapies and / or implantable devices. For example, an opening can be formed in the left atrial wall for implanting a shunt device therein, such as to provide an artificial blood flow catheter for relieving elevated left atrial pressure.

[0152] A puncture needle system may include a puncture needle. The puncture needle may include one or more features of a puncture needle as described herein. For example, the puncture needle may include an anchoring portion and a curved puncture portion. The puncture portion may include a first end associated with a puncture tip and a second end coupled to the anchoring portion. The anchoring portion may include a portion distal to the curved puncture portion. The puncture needle system may include a delivery catheter configured to receive the puncture needle. The delivery catheter may include a puncture needle lumen, and the puncture needle slidably extends through the puncture needle lumen. A side outlet opening may be present on the distal portion of the delivery catheter, such that at least a portion of the curved puncture portion may extend through the side outlet opening.

[0153] As described herein, the puncture needle may be preloaded. For example, the puncture needle may be in a desired position within the delivery catheter before positioning the delivery catheter at the target tissue site (e.g., before inserting the delivery catheter into the patient). For example, as the delivery catheter is advanced to the target tissue site, the distal portion of the puncture needle may be at or near the side outlet opening. As the delivery catheter is advanced to the target tissue site, the puncture needle may be in a retracted position within the delivery catheter. In some embodiments, when the puncture needle is in the retracted position, at least a portion of the anchoring portion is positioned within a portion of the puncture needle lumen distal to the side outlet opening. In some embodiments, the interaction between the anchoring portion and the portion of the puncture needle lumen wall distal to the side outlet opening may facilitate maintaining the axial orientation of the curved puncture portion relative to the delivery catheter, regardless of any axial rotation of the puncture needle in any portion proximal to the curved puncture portion.

[0154] In some embodiments, when the puncture needle is in the retracted state, the curved puncture portion may be positioned proximal to the side outlet opening. In some embodiments, when the puncture needle is in the retracted state, at least a portion of the curved puncture portion may be positioned distal to the side outlet opening. For example, a portion of the curved puncture portion and the puncture tip may be within the portion of the puncture needle lumen distal to the side outlet opening. In some embodiments, the puncture tip may be within the side outlet opening, and the curved puncture portion may include at least a portion positioned within the portion of the puncture needle lumen proximal to the side outlet opening.

[0155] At block 1604, procedure 1600 involves translating a puncture needle distally or proximally relative to the delivery catheter to release at least a portion of the curved puncture portion through a side outlet opening. The puncture needle may be pushed or pulled to align the curved puncture portion with the side outlet opening, such that the puncture tip and at least a portion of the curved puncture portion can extend through the side outlet opening. For example, in the retracted state, the puncture needle, including the puncture tip distal to the side outlet opening, may be translated proximally relative to the delivery catheter to release at least a portion of the curved puncture portion through the side outlet opening. In the retracted state, the puncture needle, including the puncture tip proximal to the side outlet opening, may be translated distally relative to the delivery catheter to release at least a portion of the curved puncture portion through the side outlet opening. In some embodiments, the curved puncture portion may include a shape memory material such that once at least a portion of the curved puncture portion is no longer constrained by the delivery catheter, the curved puncture portion may tend to present its desired curved configuration.

[0156] At block 1606, procedure 1600 involves extending at least a portion of the curved puncture portion through the lateral outlet opening. In the deployed state, the puncture needle may include the entirety or substantially the entirety of the curved puncture portion extending beyond the lateral outlet opening. In some embodiments, when the puncture needle is in the deployed state, only a portion of the curved puncture portion extends beyond the lateral outlet opening. As described herein, the curved puncture portion may include a pre-formed curvature configured to facilitate access to a target tissue site when the puncture needle system is positioned in a blood vessel, thereby facilitating effective puncture of the target tissue site. For example, the pre-formed curvature of the curved puncture portion may have a radius of curvature to facilitate access to and / or puncture of a target tissue site on the left atrial wall when the curved puncture portion extends from a delivery catheter positioned in the coronary sinus.

[0157] At box 1608, procedure 1600 involves using the puncture tip of a puncture needle that has extended through the lateral exit opening to puncture tissue at the target tissue site to create an opening at the target tissue site.

[0158] In some embodiments, the puncture needle system may include a medical implant guidewire sheath configured to slidably receive a medical implant guidewire. The medical implant guidewire sheath may include a distal portion coupled to at least a portion of the curved puncture portion. The medical implant guidewire may be advanced within the medical implant guidewire sheath to a target tissue site. The medical implant guidewire may be advanced through an opening associated with the distal end of the medical implant guidewire sheath into an opening formed at the target tissue site. After the medical implant guidewire is positioned at its target location, the medical implant guidewire sheath may be retracted, thereby leaving the medical implant guidewire in place. A medical implant device (e.g., a shunt device) may then be advanced along the medical implant guidewire to the target implantation site. For example, a shunt device may be advanced along the medical implant guidewire into an opening formed in the left atrial wall.

[0159] Additional Examples

[0160] Depending on the implementation, certain actions, events, or functions of any process or algorithm described herein may be performed in a different order, or may be added, combined, or omitted entirely. Therefore, in some embodiments, not all described actions or events are necessary for the practice of the process.

[0161] Unless otherwise expressly stated, or otherwise understood to be used within the context, the conditional language used herein (e.g., in particular “can,” “could,” “might,” “may,” “for example,” etc.) is intended in its general sense and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Therefore, such conditional language is not generally intended to imply that a feature, element, and / or step is necessary in any way for one or more embodiments, or to imply that one or more embodiments must include logic for determining whether such features, elements, and / or steps are included or will be performed in any particular embodiment, with or without author input or prompting. The terms “comprising,” “including,” “having,” etc., are synonyms used in their general sense and are used inclusively in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive sense (rather than its exclusive sense); for example, when used to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Unless otherwise explicitly stated, conjunction language (such as the phrase "at least one of X, Y, and Z") is generally used in conjunction with the context to convey that an item, term, element, etc., may be X, Y, or Z. Therefore, such conjunction language is generally not intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z, respectively.

[0162] It should be understood that in the above description of the embodiments, various features are sometimes combined in a single embodiment, drawing, or description therein for the purpose of simplifying the disclosure and assisting in understanding one or more of the various inventive aspects. However, the methods of this disclosure should not be construed as reflecting an intention in any claim to require more features than are expressly detailed in that claim. Furthermore, any component, feature, or step illustrated and / or described in the specific embodiments herein may be applied to or used with any other embodiment. Moreover, for each embodiment, no component, feature, step, or group of components, features, or steps is necessary or indispensable. Therefore, the scope of the invention disclosed and claimed herein should not be limited to the specific embodiments described above, but should be determined only through a fair reading of the appended claims.

[0163] 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 physical characteristics or ordering. Therefore, as used herein, ordinal terms used to modify elements (e.g., structure, component, operation, etc.) (e.g., "first," "second," "third," etc.) do not necessarily indicate the element's priority or order relative to any other element, but generally distinguish that element from another element with a similar or identical name (if no ordinal term is used). Furthermore, as used herein, indefinite articles ("a(a)" and "an(an)") may indicate "one or more" rather than "one(one)." Additionally, operations performed "based on" conditions or events may also be performed based on one or more other conditions or events that are not explicitly detailed.

[0164] Unless otherwise specified, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments pertain. It should be further understood that terms (e.g., those defined in common dictionaries) shall be interpreted as having meaning consistent with their meaning in the context of the relevant art and shall not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0165] Spatial terms such as “external,” “internal,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms may be used herein for the purpose of describing the relationship between one element or component and another element or component as illustrated in the accompanying drawings. It should be understood that, in addition to the orientations depicted in the drawings, spatial relative terms are intended to cover different orientations of the device in use or operation. For example, in the case where the device shown in the drawings is flipped, a device positioned “below” or “below” another device may be placed “above” another device. Therefore, the illustrative term “below” can include both a lower position and an upper position. The device may also be oriented in other directions, and thus spatial relative terms may be interpreted differently depending on the orientation.

[0166] Unless otherwise explicitly stated, comparative and / or quantitative terms (such as “smaller,” “more,” “larger,” etc.) are intended to encompass the concept of equality. For example, “smaller” can mean not only “smaller” in the strictest mathematical sense, but also “less than or equal to.”

Claims

1. A puncture needle, comprising: The puncture tip is designed to puncture tissue; as well as The elongated portion, wherein the elongated portion includes a distal portion, the distal portion comprising: A curved puncture portion having a first end associated with the puncture tip; A first distal elongated portion, the curved puncture portion extending from the first end to the first distal elongated portion, and the first distal elongated portion intersecting the curved puncture portion at an acute angle oriented distally; and The second distal elongated portion, the first distal elongated portion and the second distal elongated portion meet at oppositely oriented acute angles, and the second distal elongated portion extends proximally from the oppositely oriented acute angles, wherein the proximally oriented acute angles are distal to the curved puncture portion.

2. The puncture needle according to claim 1, wherein the first distal elongated portion, the second distal elongated portion, and the curved puncture portion are in a plane.

3. The puncture needle according to claim 1 or 2, wherein the elongated portion is a single wire.

4. The puncture needle according to claim 1 or 2, wherein the first distal elongated portion includes a first distal curved portion and the second distal elongated portion includes a second distal curved portion, the first distal curved portion and the second distal curved portion having the same orientation as the curved puncture portion.

5. The puncture needle according to claim 4, wherein the radius of curvature of the curved puncture portion is smaller than the radius of curvature of each of the first distal curved portion and the second distal curved portion.

6. A puncture needle, comprising: The puncture tip is designed to puncture tissue; as well as The distal portion includes: The anchoring portion includes a first anchoring portion and a second anchoring portion; as well as The curved puncture portion includes a first end associated with the puncture tip and a second end that intersects the first anchoring portion at an acute angle oriented distally, and the second anchoring portion intersects the first anchoring portion at an acute angle oriented oppositely, wherein the anchoring portion includes a portion distal to the curved puncture portion.

7. The puncture needle of claim 6, wherein the curved puncture portion is oriented proximally, and wherein the puncture tip is directed proximally.

8. The puncture needle according to claim 6 or 7, wherein the curved puncture portion comprises a circular segment.

9. The puncture needle according to claim 8, wherein the curved puncture portion comprises a semicircle.

10. The puncture needle according to claim 6 or 7, wherein the distal portion comprises a transverse section having a rectangular shape, the transverse section being cut along a plane perpendicular to the longitudinal axis of the puncture needle.

11. The puncture needle according to claim 6 or 7, wherein: The first anchoring portion includes a first end and a second end, wherein the first end of the first anchoring portion is coupled to the curved puncture portion; as well as The second anchoring portion includes a first end coupled to the second end of the first anchoring portion, and wherein the second anchoring portion extends proximally from the first end of the second anchoring portion. The first anchoring portion and the second anchoring portion meet at the bend, the bend being oriented proximally and distal to the bend puncture portion.

12. The puncture needle of claim 11, wherein the curved portion includes an acute angle.

13. The puncture needle of claim 11, wherein the curved puncture portion, the first anchoring portion, and the second anchoring portion are in a plane.

14. The puncture needle of claim 11, wherein the first anchoring portion is a first curved anchoring portion, and the second anchoring portion is a second curved anchoring portion.

15. The puncture needle of claim 14, wherein the curved puncture portion, the first curved anchoring portion, and the second curved anchoring portion have the same orientation.

16. The puncture needle of claim 14, wherein the radius of curvature of the curved puncture portion is smaller than the radius of curvature of each of the first curved anchor portion and the second curved anchor portion.

17. The puncture needle of claim 14, wherein both the first curved anchor portion and the second curved anchor portion comprise a shape configured to conform to the curvature along the length of the coronary sinus.

18. A puncture needle system, comprising: A puncture needle, comprising a puncture tip and a distal portion, the distal portion comprising: The anchoring portion includes a first anchoring portion and a second anchoring portion, and A curved puncture portion includes a first end associated with the puncture tip and a second end that intersects the first anchoring portion at a distally oriented acute angle, and the second anchoring portion intersects the first anchoring portion at an oppositely oriented external acute angle, and the anchoring portion includes a portion distal to the curved puncture portion; and A delivery catheter includes a lumen and a side outlet opening on a distal portion of the delivery catheter, through which a puncture needle extends, the side outlet opening being configured to allow at least a portion of the curved puncture portion to extend through it, wherein the anchoring portion extends through the lumen on a distal portion distal to the side outlet opening.

19. The system of claim 18, wherein the distal portion of the lumen distal to the side outlet opening comprises a transverse section having a non-circular shape, the transverse section being cut along a plane perpendicular to the longitudinal axis of the delivery catheter.

20. The system of claim 19, wherein the transverse section of the distal portion of the lumen comprises the same shape as the transverse section of the anchoring portion.

21. The system of any one of claims 18 to 20, further comprising a medical implantable guidewire sheath configured to slidably receive a medical implantable guidewire, the medical implantable guidewire sheath including a distal portion coupled to at least a portion of the curved puncture portion.

22. The system according to claim 18 or 19, wherein: The first anchoring portion includes a first end and a second end, wherein the first end of the first anchoring portion is coupled to the curved puncture portion; as well as The second anchoring portion includes a first end coupled to the second end of the first anchoring portion, and wherein the second anchoring portion extends proximally from the first end of the second anchoring portion. The first anchoring portion and the second anchoring portion meet at the bend, the bend being oriented proximally and distal to the bend puncture portion.

23. The system of claim 22, wherein the curved puncture portion, the first anchoring portion, and the second anchoring portion are in a plane.

24. The system of claim 22, wherein the first anchoring portion is a first curved anchoring portion and the second anchoring portion is a second curved anchoring portion, wherein the curved puncture portion, the first curved anchoring portion and the second curved anchoring portion have the same orientation.

25. The system according to claim 18 or 19, wherein, While the puncture needle is in the retracted state, the puncture tip is configured proximal to the side outlet opening, and the anchoring portion includes a portion of the lumen extending through the side outlet opening and passing through the lumen distal to the side outlet opening.

26. The system according to claim 18 or 19, wherein, While the puncture needle is in the retracted state, the puncture tip is configured to be distal to the side outlet opening and the anchoring portion extends distally through the portion of the lumen distal to the side outlet opening.

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