Transcatheter medical implant delivery

Abstract

A medical implant delivery system may include a puncture needle, a medical implant delivery catheter configured to slidably advance the puncture needle through a puncture needle lumen of the catheter, a medical implant device positioned on the catheter, and an outer delivery catheter with a medical implant delivery lumen, the implant delivery catheter configured to slidably extend through the lumen. A medical implant delivery system may include a puncture needle, a medical implant delivery catheter configured to slidably extend through a puncture needle lumen of the catheter, a medical implant device positioned on the catheter, an elongate housing adjacent the catheter, and an outer sheath around a portion of the catheter and the elongate housing.

Description

【Technical Field】 【0001】 Cross - reference to related applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 935,214, filed on November 14, 2019, entitled "TRANSCATHETER MEDICAL IMPLANT DELIVERY", the disclosure of which is hereby incorporated by reference in its entirety for all purposes. 【0002】 This disclosure generally relates to the field of transcatheter delivery of medical implant devices and / or treatments. 【Background Art】 【0003】 Transcatheter delivery of medical implant devices and / or treatments to target vasculature, passages, chambers, and / or organs can be performed to treat various diseases. Transcatheter delivery of medical implant devices and / or treatments to the heart can be performed to address various cardiac conditions, including elevated left atrial pressure. 【Prior Art Documents】 【Patent Documents】 【0004】 【Patent Document 1】 U.S. Patent Application Publication No. 15 / 335,891 【Summary of the Invention】 【Means for Solving the Problems】 【0005】 Described herein are systems and methods for providing minimally invasive transcatheter delivery of medical implant devices and / or treatments, including delivery of a medical implant device to the left atrial wall to reduce elevated left atrial pressure. 【0006】 In one implementation, a medical implant delivery system may comprise a puncture needle, a medical implant delivery catheter, a medical implant device, and an external delivery catheter. The puncture needle comprises an elongated portion and a puncture component associated with the distal end of the elongated portion, the puncture component being configured to perforate and form an opening in the target tissue wall. The medical implant delivery catheter may comprise a puncture needle lumen, the puncture needle being configured to advance through the puncture needle lumen, and the puncture component being configured to extend through a puncture needle exit opening associated with the distal portion of the medical implant delivery catheter. The medical implant device may be positioned on the medical implant delivery catheter. The external delivery catheter may comprise a medical implant delivery lumen, the medical implant delivery catheter being configured to advance through the medical implant delivery lumen, the distal portion of the medical implant delivery catheter being received into the medical implant delivery lumen and configured to extend through a lateral exit opening associated with the distal portion of the external delivery catheter. 【0007】 In one embodiment, the medical implant delivery system may include a puncture needle sheath configured to pass through a puncture needle lumen, and the puncture needle is configured to pass through the lumen of the puncture needle sheath. A radially expandable member can be associated with the distal portion of the puncture needle sheath, and the radially expandable member is positioned within an opening formed in the target tissue wall and is configured to enlarge the opening when the radially expandable member is in an expanded configuration. In one embodiment, the medical implant delivery system may include a medical implant delivery guide wire, which is configured to slide forward through the lumen of the puncture needle sheath and is configured to be interchangeable with the puncture needle. 【0008】 In one embodiment, the distal portion of a medical implant delivery catheter is configured to be inserted into an opening formed in the wall of a target tissue, and the distal portion has a predetermined diameter configured to enlarge the opening. 【0009】 In one embodiment, the medical implant delivery system may include an external delivery catheter guide wire, and the external delivery catheter includes a guide wire lumen configured to receive the external delivery catheter guide wire. In one embodiment, the external delivery catheter guide wire lumen extends along a longitudinal axis offset from the center of the external delivery catheter. 【0010】 In one embodiment, the distal portion of the medical implant delivery catheter has a cross-section configured to interlock with the shape of the lateral outlet opening at the distal portion of the outer delivery catheter in order to orient the medical implant delivery catheter as it extends through the lateral outlet opening, the cross-section extending along the transverse dimension of the distal portion of the outer delivery catheter. 【0011】 In one embodiment, the medical implant delivery catheter comprises a first tapered distal section having a first pre-formed curve, and the external delivery catheter comprises a second tapered distal section having a second pre-formed curve, wherein the first and second curves have the same orientation. In one embodiment, the first pre-formed curve has a radius of curvature smaller than that of the second pre-formed curve. In one embodiment, the second pre-formed curve has a shape configured to coincide with at least a portion of the curve along the length of the coronary sinus. In one embodiment, the lateral outlet opening is located on the inner edge of the second pre-formed curve of the external delivery catheter. 【0012】 In one embodiment, the puncture needle has a third pre-formed curve at its distal end. In another embodiment, the third pre-formed curve has a radius of curvature smaller than the radius of curvature of the first pre-formed curve of the medical implant delivery catheter. 【0013】 In one embodiment, the medical implant delivery system may include an expandable anchoring portion, the expandable anchoring portion and the lateral exit opening located on the opposite side of the external delivery catheter, and the expandable anchoring portion is configured to expand in order to position the external delivery catheter against the target tissue wall. In one embodiment, the external delivery catheter has a second tapered distal portion with a second pre-formed curve, and the anchoring portion is located on the outer edge of the second pre-formed curve. 【0014】 In one implementation, a method for delivering a medical implant device may include the steps of advancing a guide wire into a blood vessel and advancing a medical implant delivery system along the guide wire into the blood vessel. The medical implant delivery system may comprise an external delivery catheter having a medical implant delivery lumen, a medical implant device positioned thereon, and a medical implant delivery catheter having a puncture needle lumen extending therethrough, the medical implant delivery catheter being slidably extended through the medical implant delivery lumen, and a puncture needle being slidably extended through the puncture needle lumen, the puncture component of the puncture needle extending through a distal exit opening at the distal end of the medical implant delivery catheter. The method may include advancing the medical implant delivery catheter through a lateral exit opening at the distal end of the external delivery catheter and puncturing the tissue using the puncture component extending through the distal exit opening to form an opening in the tissue at the target tissue site. The distal end of the medical implant delivery catheter can be extended through an opening formed in the tissue, and the medical implant device positioned at the distal end of the medical implant delivery catheter can be deployed into the opening formed in the tissue. 【0015】 In one embodiment, the method may include the steps of inserting a radially expandable member, positioned distal to a puncture needle sheath, into an opening formed in tissue, and expanding the radially expandable member to enlarge the opening, wherein the puncture needle sheath extends slidably through the puncture needle lumen, and the puncture needle extends slidably through the lumen of the puncture needle sheath. 【0016】 In one embodiment, the method may include the step of replacing the puncture needle with a medical implant delivery guide wire and inserting the medical implant delivery guide wire through the lumen of the puncture needle sheath. 【0017】 In one embodiment, the method may include the step of inserting the distal end of a medical implant delivery catheter into an opening in order to enlarge the opening formed at the target tissue site. 【0018】 In one embodiment, the method may include the step of oriented the distal portion of a medical implant delivery catheter within a medical implant delivery lumen and extending the distal portion through a lateral exit opening, wherein oriented includes rotating the distal portion of the medical implant delivery catheter to match the shape of the cross section of the distal portion with the shape of the lateral exit opening, the cross section extending along the lateral dimension of the distal portion of the lateral delivery catheter. 【0019】 In one embodiment, the method may include the step of expanding the expandable anchoring portion at the distal end of the external delivery catheter in order to bring the expandable anchoring portion into contact with the wall of a blood vessel. 【0020】 In one embodiment, positioning the guide wire into a blood vessel includes positioning the guide wire transfemorally into the coronary sinus through the right atrium via the hilum of the coronary sinus. In another embodiment, the step of perforating tissue at a target tissue site includes perforating tissue in the left atrial wall to form an opening in the left atrial wall, and the step of deploying a medical implant device includes deploying the medical implant device into the opening formed in the left atrial wall. 【0021】 In one embodiment, the medical implant delivery system may comprise a puncture needle, a medical implant delivery catheter, a medical implant device, an elongated housing, and an outer sheath. The puncture needle may comprise an elongated portion and a puncture component at the distal end of the elongated portion, the puncture component being configured to perforate tissue to form an opening in the tissue. The medical implant delivery catheter comprises a puncture needle lumen, the puncture needle being configured to extend slidably through the puncture needle lumen, and the puncture component being configured to extend through a puncture needle exit opening at the distal end of the medical implant delivery catheter. The medical implant device may be supported on the medical implant delivery catheter. The elongated housing is adjacent to the medical implant delivery catheter and slidable relative to the medical implant delivery catheter, with the distal end of the elongated housing distal to the distal end of the medical implant delivery catheter when the medical implant delivery catheter is in a retracted configuration. An outer sheath may be present around a portion of the medical implant delivery catheter and the elongated housing to maintain the medical implant delivery catheter adjacent to the elongated housing, and the outer sheath is slidable relative to the medical implant delivery catheter and extends to cover the distal end of the medical implant delivery catheter when the medical implant delivery catheter is in a retracted configuration. 【0022】 In one embodiment, the elongated housing includes a recess along at least a portion of the length of the elongated housing, and a portion of the medical implant delivery catheter is received within the recess. In one embodiment, the elongated housing includes a guide wire lumen configured to receive an elongated housing guide wire, and the distal end of the elongated housing includes a guide wire exit opening configured to allow the elongated housing guide wire to extend through the elongated housing. 【0023】 In one embodiment, the medical implant delivery catheter includes a first tapered distal portion having a first preformed curvature, and the elongated housing includes a second tapered distal portion having a second preformed curvature, and the first preformed curvature and the second preformed curvature have the same orientation. In one embodiment, the first preformed curvature has a radius of curvature smaller than the radius of curvature of the second preformed curvature. In one embodiment, the second preformed curvature has a shape configured to conform to a curvature along the length of the coronary sinus. 【0024】 In one embodiment, the medical implant delivery system can include an expandable anchor at the distal portion of the elongated housing opposite a portion of the elongated housing adjacent to the medical implant delivery catheter, and the expandable anchor is configured to take an expanded configuration to position the medical implant delivery catheter against a target tissue site. In one embodiment, the elongated housing includes a second tapered distal portion having a second preformed curvature, and the expandable anchor is at an outer edge of the second preformed curvature. 【0025】 In one embodiment, the medical implant delivery system can include a puncture needle sheath slidably extending through a puncture needle lumen, and a puncture needle slidably extending through the puncture needle sheath. A radially expandable member can be at the distal portion of the puncture needle sheath and is configured to expand an opening formed in the tissue. 【0026】 In one embodiment, the puncture needle is configured to be replaceable with a medical implant delivery guide wire. 【0027】 In one implementation, a method for delivering a medical implant device can include positioning a guide wire into a blood vessel and advancing a medical implant delivery system along the guide wire into the blood vessel. The medical implant delivery system can include an elongate housing, a medical implant delivery catheter adjacent to the elongate housing that carries a medical implant device and includes a puncture needle lumen, a puncture needle slidably extending through the puncture needle lumen, where a puncturing component of the puncture needle extends through a distal exit opening at a distal end of the medical implant delivery catheter, and an outer sheath around the elongate housing and the medical implant delivery catheter. The method can include sliding the outer sheath proximally to release a distal portion of the medical implant delivery catheter, sliding the medical implant delivery catheter distally relative to the elongate housing, puncturing tissue to form an opening in the tissue at a target tissue site using the puncturing component extending through the distal exit opening of the medical implant delivery catheter, extending the distal portion of the medical implant delivery catheter through the opening in the tissue, and deploying the medical implant device carried by the medical implant delivery catheter into the opening. 【0028】 In one embodiment, the method can include positioning a radially expandable member at a distal portion of the puncture needle sheath at an opening formed in the tissue and expanding the radially expandable member to expand the opening, where the puncture needle sheath slidably extends through the puncture needle lumen and the puncture needle slidably extends through the lumen of the puncture needle sheath. In one embodiment, the method can include replacing the puncture needle with a medical implant delivery guide wire and inserting the medical implant delivery guide wire through the lumen of the puncture needle sheath. 【0029】 In one embodiment, the method may include the step of inserting the distal end of a medical implant delivery catheter into an opening in order to enlarge the opening formed at the target tissue site. 【0030】 In one embodiment, the method may include the step of expanding the expandable anchoring portion at the distal end of the elongated housing in order to bring the expandable anchoring portion into contact with the wall of a blood vessel. 【0031】 In one embodiment, the step of positioning the guide wire into a blood vessel includes positioning the guide wire transfemorally into the coronary sinus through the right atrium via the hilum of the coronary sinus. In another embodiment, the step of perforating tissue at a target tissue site includes perforating tissue in the left atrial wall, and the step of deploying a medical implant device includes deploying the medical implant device into an opening formed in the left atrial wall. 【0032】 For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features are described herein. It will be understood that not all such advantages can necessarily be achieved by any particular embodiment. Accordingly, the embodiments disclosed may be carried out in a manner that achieves or optimizes one advantage or set of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein. 【0033】 Various embodiments are depicted in the accompanying drawings for illustrative purposes, but should not be construed as limiting the scope of the invention. Furthermore, various features of different embodiments disclosed can be combined to form additional embodiments which are part of this disclosure. Reference numerals may be reused throughout the drawings to indicate correspondences between reference elements. However, it should be understood that the use of similar numerals in relation to multiple drawings does not necessarily imply similarity between the respective embodiments associated with them. Furthermore, it should be understood that the features in each drawing are not necessarily to the same scale, and their illustrated sizes are presented for illustrative purposes of aspects of the invention. In general, some of the illustrated features may be relatively smaller than those illustrated in a particular embodiment or configuration. [Brief explanation of the drawing] 【0034】 [Figure 1] This is a cross-section of a human heart. [Figure 2] This is another cross-section of a human heart. [Figure 3] This is a side view of an example of a medical implant delivery system according to one or more embodiments. [Figure 4] This is another side view of the medical implant delivery system of Figure 3 according to one or more embodiments. [Figure 5] This is a side view of the external delivery catheter of the medical implant delivery system shown in Figure 3, according to one or more embodiments. [Figure 6] This is a side view of a medical implant delivery catheter of the medical implant delivery system of Figure 3 according to one or more embodiments. [Figure 7] Figure 3 shows a proximal handle of a medical implant delivery system according to one or more embodiments. [Figure 8A] This is a longitudinal cross-sectional view of the medical implant delivery system of Figure 3 in a first configuration, according to one or more embodiments. [Figure 8B]This is a longitudinal cross-sectional view of the medical implant delivery system of Figure 3 in a second configuration, according to one or more embodiments. [Figure 9] This is a cross-sectional view of the external delivery catheter shown in Figure 5, according to one or more embodiments. [Figure 10A] This is a top view of an external delivery catheter, an example of a medical implant delivery system according to one or more embodiments. [Figure 10B] This is a longitudinal cross-sectional view of an external delivery catheter of an example of a medical implant delivery system according to one or more embodiments. [Figure 10C] Figures 10A and 10B show top views of a medical implant delivery catheter for a medical implant delivery system according to one or more embodiments. [Figure 10D] Figures 10A and 10B are side views of a medical implant delivery catheter for a medical implant delivery system according to one or more embodiments. [Figure 11] This diagram illustrates the insertion of a guide wire into the coronary sinus according to one or more embodiments. [Figure 12] Figure 3 shows the advance of one or more embodiments of a medical implant delivery system into the coronary sinus. [Figure 13] This figure shows the use of a puncture needle of the medical implant delivery system shown in Figure 3 for puncturing tissue at a target tissue site in the left atrial wall, according to one or more embodiments. [Figure 14] Figure 3 shows a puncture needle for a medical implant delivery system inserted into the left atrium, according to one or more embodiments. [Figure 15] This figure shows the deployment of a shunt device to the left atrial wall using the medical implant delivery system of Figure 3, according to one or more embodiments. [Figure 16] This figure shows the withdrawal of the medical implant delivery system from the coronary sinus after deployment of the medical implant device into the left atrial wall according to one or more embodiments. [Figure 17]This is a flowchart illustrating an example of the process for deploying the medical implant delivery system shown in Figure 3 to deliver a medical implant device, according to one or more embodiments. [Figure 18] This is a side view of another example of a medical implant delivery system according to one or more embodiments. [Figure 19] Figure 18 is a side view of a medical implant delivery system comprising a puncture needle in an extended configuration, according to one or more embodiments. [Figure 20] Figure 18 is a side view of a medical implant delivery system in which the outer sheath is translated proximal to the outside, according to one or more embodiments. [Figure 21] Figure 18 shows the advance of a medical implant delivery system into the coronary sinus according to one or more embodiments. [Figure 22] Figure 18 shows the proximal translation of the outer sheath of the medical implant delivery system and the distal translation of the medical implant delivery catheter while the medical implant delivery system is positioned in the coronary sinus according to one or more embodiments. [Figure 23] Figure 18 shows a puncture needle for a medical implant delivery system inserted into the left atrium, according to one or more embodiments. [Figure 24] This figure shows the deployment of a shunt device to the left atrial wall using the medical implant delivery system of Figure 18, according to one or more embodiments. [Figure 25] This is a flowchart illustrating an example of the process for deploying the medical implant delivery system of Figure 18 to deliver a medical implant device according to one or more embodiments. [Modes for carrying out the invention] 【0035】 The titles provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed inventions. 【0036】 This disclosure relates to a system and method for providing minimally invasive transcatheter delivery of medical implants and / or treatments to target tissue sites in blood vessels, passages, ventricles, and / or organs, including the delivery of shunt devices to target tissue walls such as the left atrial wall. 【0037】 While certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the explicitly disclosed embodiments to other alternative embodiments and / or uses, as well as their variations and equivalents. Therefore, the claims that may arise from this specification are not limited by any of the specific embodiments 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 specific order disclosed. Various operations may be described successively as multiple separate operations in a manner that may help in understanding a particular embodiment, but the order of description should not be interpreted as meaning that these operations are order-dependent. Furthermore, the structures, systems, and / or apparatus described herein may be embodied as integrated components or as separate components. For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any specific embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one or more advantages, as taught herein, without necessarily achieving other embodiments or advantages, as may also be taught or proposed herein. 【0038】 Specific standard anatomical terms for location are used herein with reference to the biological structures of animals, i.e., human biological structures, in relation to preferred embodiments. Certain spatially relative terms, such as “outside,” “inside,” “above,” “below,” “below ~,” “above ~,” “vertical,” “horizontal,” “up,” “down,” and similar terms, are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, but it is understood that these terms are used herein for ease of description to describe the positional relationships between elements / structures, as shown in the drawings. It should be understood that the spatially relative terms are intended to cover different orientations of elements / structures in use or operation, in addition to the orientations depicted in the drawings. For example, an element / structure described as “above” another element / structure may represent a position below or beside such other element / structure with respect to an alternative orientation of the subject or element / structure, and vice versa. 【0039】 Various features of the heart 1 are described with reference to Figure 1 to help understand this disclosure. The heart 1 comprises four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. A muscular wall called the septum 10 separates the left atrium 2 from the right atrium 5 and separates the left ventricle 3 from the right ventricle 4. Blood flow through the heart 1 is at least partially controlled 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 from the left ventricle 3 and controls blood flow between them. The aortic valve 7 separates the left ventricle 3 from the aorta 12 and controls blood flow between them. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4 and controls blood flow between them. The pulmonary valve 9 separates the right ventricle 4 from the pulmonary artery 11 and controls blood flow between them. 【0040】 In a healthy heart, the heart valves can open and close appropriately in response to the pressure gradients present during the different stages of the cardiac cycle (e.g., relaxation and contraction) to control, at least partially, the flow of blood to each region of the heart and / or to the blood vessels. Deoxygenated blood coming from other parts of the body generally flows to the right side of the heart for transport to the lungs, and oxygenated blood from the lungs generally flows to the left side of the heart for transport to other parts of the body. During ventricular diastole, deoxygenated blood arrives in the right atrium 5 from the inferior vena cava 15 and superior vena cava 16 and flows into the right ventricle 4, while oxygenated blood arrives in the left atrium 2 from the pulmonary veins and flows into the left ventricle 3. During ventricular contraction, deoxygenated blood from the right ventricle 4 can flow into the pulmonary artery 11 for transport to the lungs (e.g., via the left pulmonary artery 14 and right pulmonary artery 13), and oxygenated blood can flow from the left ventricle 3 into the aorta 12 for transport to other parts of the body. 【0041】 Several conditions can contribute to higher-than-normal pressure in the left atrium. Mitral valve dysfunction can contribute to increased left atrial pressure. Conditions such as mitral valve regurgitation and / or stenosis can make it difficult to pump blood from the left atrium to the left ventricle, potentially contributing to increased pressure in the left atrium. Valve stenosis can narrow or block the valve. Mitral stenosis can restrict blood flow from the left atrium to the left ventricle. Valve regurgitation occurs when the valve does not close properly. For example, regurgitation can occur due to improper joining of the valve lobes. Mitral regurgitation can result in leakage of blood flow from left ventricle 3 back to left atrium 2 when left ventricle 3 contracts. Both restricted blood flow from left atrium 2 to left ventricle 3 and leakage of blood flow back from left ventricle 3 to left atrium 2 can contribute to increased atrial pressure. Dysfunction in left ventricle 3 can contribute to elevated left atrial pressure. This elevated pressure can lead to left atrium enlargement, potentially causing symptoms such as shortness of breath during exertion, fatigue, chest pain, syncope, abnormal heartbeat, and swelling of the legs and feet. 【0042】 Figure 2 is another diagram of the heart 1, showing the coronary sinus 18 around the left atrium 2. To alleviate the increase in left atrial pressure, a conduit may be provided to allow blood flow from the left atrium 2 to a lower-pressure portion of the heart, such as the coronary sinus 18. The conduit may be formed in the wall of the left atrium 2 adjacent to the coronary sinus 18 to allow blood flow from the left atrium 2 to the coronary sinus 18. The coronary sinus 18 receives blood from the coronary veins and flows into the right atrium 5. The blood delivered from the left atrium 2 to the coronary sinus 18 may then be delivered to the right atrium 5. A shunt device, including an expandable shunt device, may be positioned in a location on the left atrial wall, such as a location accessible from the coronary sinus 18, to form a pathway for blood flow from the left atrium 2 to the coronary sinus 18. Access to the coronary sinus 18 may include leading to the right atrium 5 and entering through the coronary sinus hilum 17. 【0043】 Conventional minimally invasive transcatheter deployment of medical implant devices and / or treatments to a target tissue site may involve advancing a needle delivery catheter and a medical implant delivery catheter separately, including transcatheter delivery of a shunt device to the left atrial wall. After an opening is formed at the target tissue site using a needle, the needle delivery catheter may be replaced with a medical implant delivery catheter to deliver the medical implant device and / or treatment. Medical implant devices and / or treatments may be delivered to a target tissue site in the heart to alter blood flow in the heart in order to treat a variety of abnormal cardiac conditions. For example, a shunt device may be delivered to the left atrial wall to provide a pathway for blood flow between the left atrium and the coronary sinus to reduce elevated left atrial pressure. Delivery of a shunt device to the left atrial wall may require the formation of an opening in the left atrial wall. Typically, the needle delivery catheter and the shunt device delivery catheter are introduced separately to form an opening at the target tissue site and to position the shunt device at the opening, respectively. The puncture needle delivery catheter may be retracted and replaced with a shunt device delivery catheter. Replacing the puncture needle delivery catheter with a shunt device delivery catheter may result in undesirable trauma to the patient, increased procedure complexity, and / or increased procedure time. 【0044】 This disclosure provides systems and methods for minimally invasive transcatheter delivery of medical implant devices and / or treatments to a target tissue site. In some embodiments, described herein is a medical implant delivery system configured to enable the simultaneous positioning of both a puncture needle for puncturing tissue at a target tissue site and a medical implant device and / or treatment for deployment to the target tissue site at or near the target tissue site. The puncture needle and the medical implant device and / or treatment can be delivered together at or near the target tissue site without the need to replace the puncture needle delivery catheter with a delivery catheter for delivering the medical implant device and / or treatment. Delivering the puncture needle and the medical implant device and / or treatment together at the target tissue site without the need to advance the puncture needle delivery catheter and the delivery catheter for the medical implant device and / or treatment separately can facilitate a reduction in trauma to the patient, provide a simplified procedure, and / or improve procedure time. In some embodiments, the use of one or more systems described herein can facilitate a reduction of up to 50% in procedure time. 【0045】 In some embodiments, provided herein is a medical implant delivery system for delivering a puncture needle and a shunt device, such as an expandable shunt device, to a target tissue wall, including the left atrial wall. In some embodiments, the medical implant delivery system may be configured to position itself into the coronary sinus to access a portion of the left atrial wall from within the coronary sinus. For example, the medical implant delivery system may be advanced from the right atrium through the coronary sinus hilum into the coronary sinus. The right atrium may be accessed via the superior vena cava (SVC) or via the inferior vena cava (IVC). Transcervical or transclavicular techniques can be used to access the right atrium via the superior vena cava. Alternatively, transfemoral techniques may be used to position the medical implant delivery system into the inferior vena cava and from the inferior vena cava into the right atrium. 【0046】 In one embodiment, a medical implant delivery system as described herein may comprise an external delivery catheter and a medical implant delivery catheter slidably extending through a medical implant delivery lumen of the external delivery catheter. The medical implant delivery catheter may comprise a puncture needle lumen configured to slidably receive a puncture needle. The puncture needle may extend through an opening at the distal end of the medical implant delivery catheter. A medical implant device may be positioned on the medical implant delivery catheter, such as at the distal end of the medical implant delivery catheter. For example, a shunt device, such as an expandable shunt device, may be positioned circumferentially around the distal end of the medical implant delivery catheter. 【0047】 The external delivery catheter can be advanced into the coronary sinus along a guide wire. The distal end of the medical implant delivery catheter can be positioned at or near the exit opening of the external delivery catheter. In some embodiments, the medical implant delivery catheter can be pre-assembled into the external delivery catheter. In some embodiments, the medical implant delivery catheter does not need to be pre-assembled and can be advanced from the proximal end of the external delivery catheter to the exit opening after the external delivery catheter has been positioned at the desired location in the coronary sinus. The distal end of the medical implant delivery catheter can be extended through the exit opening to allow contact between the puncture needle and the target tissue site to form an opening in the target tissue site. After the puncture needle has perforated the tissue, the medical implant delivery catheter can be further extended so that the delivery catheter for deploying the shunt device can be deployed without replacing the delivery catheter for delivering the puncture needle, by extending the distal end of the medical implant delivery catheter through the opening formed in the target tissue site to deploy the shunt device to the opening. 【0048】 In one embodiment, the medical implant delivery system described herein may comprise an elongated housing, a medical implant delivery catheter extending alongside the elongated housing, and an outer sheath around the elongated housing and the medical implant delivery catheter. The medical implant device may be positioned on the medical implant delivery catheter, including a shunt device such as an expandable shunt device. For example, the shunt device may be circumferential around the distal end of the medical implant delivery catheter. The medical implant delivery catheter may include a puncture needle lumen, through which a puncture needle may be slidably extended. The puncture needle may be configured to extend through an opening at the distal end of the medical implant delivery catheter. 【0049】 The elongated housing and medical implant delivery catheter can be advanced along a guide wire into the coronary sinus. While being advanced to the desired location within the coronary sinus, the outer sheath can be positioned to cover the distal end of the medical implant delivery catheter to keep it aligned with the elongated housing. Subsequently, the outer sheath can be translated proximal to the medical implant delivery catheter to release it. The medical implant delivery catheter can be extended distally to allow contact between the puncture needle and the target tissue site to form an opening in the target tissue site. After the puncture needle has perforated the tissue, the medical implant delivery catheter can be further extended so that the distal portion of the medical implant delivery catheter extends through the opening formed in the target tissue site to deploy the shunt device, thereby enabling the deployment of the shunt device without the need to replace the delivery catheter used to deliver the puncture needle. 【0050】 The term “association” is used herein in accordance with its broad, ordinary meaning. For example, when a first feature, element, component, apparatus, or member is described as “associated” with a second feature, element, component, apparatus, or member, such description should be understood to indicate that the first feature, element, component, apparatus, or member is physically joined, physically attached, physically connected, integrated, at least partially embedded, or otherwise related to the second feature, element, component, apparatus, or member, whether directly or indirectly. 【0051】 References to “catheter” and / or “delivery catheter” herein generally refer to or may apply to any type of elongated tubular delivery device having an internal lumen configured to slidably receive instruments, such as a delivery sheath and / or cannula, for positioning within the atrium or coronary sinus. 【0052】 Figure 3 is a side view of an example of a medical implant delivery system 100 comprising an external delivery catheter 200 and a medical implant delivery catheter 300 slidably extending through a medical implant delivery lumen of the external delivery catheter 200. The medical implant delivery catheter 300 may include a puncture needle lumen configured to slidably receive a puncture needle 400. In one embodiment, the medical implant delivery system 100 may include a puncture needle sheath (not shown) extending through the puncture needle lumen, and the puncture needle 400 may extend through the puncture needle sheath. The puncture needle 400 can be delivered to a target tissue site to form an opening in the tissue. A medical implant device 350 (not shown) may be positioned on the medical implant delivery catheter 300 for deployment to a target tissue site. The medical implant device 350 may be positioned on the medical implant delivery catheter 300 such that the delivery catheter for delivering the puncture needle 400 does not need to be replaced with a delivery catheter for delivering the medical implant device 350. 【0053】 In Figure 3, the distal portion 302 of the medical implant delivery catheter 300 is shown extending through a lateral exit opening 214 in the distal portion 202 of the external delivery catheter 200, and the puncture needle 400 is shown having a portion extending beyond the distal end 310 of the medical implant delivery catheter 300. The distal portion 202 of the external delivery catheter 200 is shown in Figure 3. As shown in the figure, the distal portion 202 may be equipped with a pre-formed curve 204. The pre-formed curve 204 may be configured to facilitate the positioning of the external delivery catheter 200 to a blood vessel, passage, chamber, and / or organ to access a target tissue site. The target tissue site may be part of the same blood vessel, passage, chamber, and / or organ, or a different blood vessel, passage, chamber, and / or organ. The target tissue site may be located in the wall of a blood vessel, passage, chamber, and / or organ. For example, the external delivery catheter 200 may be positioned towards the coronary sinus to access a portion of the left atrial wall accessible from within the coronary sinus. The lateral exit opening 214 may be located on the medial edge 206 of a pre-formed curve 204. In one embodiment, the distal portion 202 may include one or more radiopaque markers to facilitate visualization of the external delivery catheter 200 in order to position it at a desired location within a blood vessel, passage, chamber, and / or organ. 【0054】 The guide wire 50 may be slidably extended through the guide wire lumen of the outer delivery catheter 200. The guide wire 50 is shown in Figure 3 as extending beyond the distal end 210 of the outer delivery catheter 200. The guide wire 50 may be positioned toward a blood vessel, passage, chamber, and / or organ so that the outer delivery catheter 200 can later advance toward a blood vessel, passage, chamber, and / or organ along the guide wire 50. 【0055】 In one embodiment, the external delivery catheter 200 may include an expandable anchoring section 250. In one embodiment, the expandable anchoring section 250 may include an expandable balloon anchoring section. The expandable anchoring section 250 may include any number of configurations that enable controlled activation and / or operation so that it can move from a flattened state to an expanded state, and from an expanded state to a flattened state. The expandable anchoring section 250 is shown in the flattened state in Figure 3. The expandable anchoring section 250 may be located on the outer edge 208 of a pre-formed curve 204. For example, the expandable anchoring section 250 may be located on the portion of the external delivery catheter 200 opposite the portion of the lateral exit opening 214. In one embodiment, the expandable anchoring section 250 may be inserted into or near the target tissue site in a flattened configuration. Subsequently, the expandable anchoring section 250 may be activated and / or operated to take an expanded configuration to contact the tissue near the target tissue site in order to facilitate stable positioning of the external delivery catheter 200. Reliable positioning of the external delivery catheter 200 relative to the target tissue site can facilitate tissue puncture at the target tissue site. In some embodiments, the expandable anchoring portion 250 can press against tissue near the target tissue site, including tissue at a location opposite the target tissue site. Expansion of the expandable anchoring portion 250 can push the delivery catheter 200 toward tissue adjacent to the target tissue, for example, by pressing the delivery catheter 200 against tissue adjacent to the target tissue. The portion of the internal edge 206 of the external delivery catheter 200 with the lateral exit opening 214 can be positioned against tissue adjacent to the target tissue site so that the puncture needle 400 can be reliably positioned at the target tissue site as the puncture needle 400 is advanced through the lateral exit opening 214. In some embodiments, the expandable anchoring portion 250 can be expanded so that the internal edge 206 of the delivery catheter 200 can be pressed against a portion of the left atrial wall adjacent to the target tissue site. This allows the lateral outlet opening 214 to be reliably positioned in and around the target tissue site in the left atrial wall. The expandable anchoring portion 250 can be re-contracted for retraction from the target tissue site. 【0056】 In some embodiments, the external delivery catheter may not have an expandable anchoring portion. In some embodiments, an external delivery catheter with an expandable anchoring portion may be selected for patients with blood vessels, passages, chambers, and / or organs having a larger diameter at or near the target tissue site. 【0057】 Figure 4 is another side view of the medical implant delivery system 100. The distal portion 302 of the medical implant delivery catheter 300 is shown extending beyond the lateral exit opening 214. The expandable anchoring portion 250 is shown in the expanded state in Figure 4. As described in further detail herein, the medical implant delivery catheter 300 may include a pre-formed curve 304 configured to facilitate the delivery of the puncture needle 400 to the target tissue site and / or the deployment of the medical implant device 350 positioned in the medical implant delivery catheter 300. 【0058】 The puncture needle exit opening 312 may be associated with the distal portion 302 of the medical implant delivery catheter 300, including the distal end 310. The puncture needle 400 may have an elongated portion 402. The distal portion 404 of the elongated portion 402 is shown extending through the puncture needle exit opening 312. A puncture component 408 associated with the distal end 406 of the elongated portion 402 may be used to perforate tissue at the target tissue site to form an opening in the tissue. In some embodiments, the distal portion 404 of the puncture needle 400 may have a pre-formed curve 410. In some embodiments, the pre-formed curve 410 of the puncture needle 400 can facilitate perforation of tissue at the target tissue site. The target tissue site may face the side of the lateral delivery catheter 200 (for example, at or near the lateral exit opening 214). As described herein, the medical implant delivery catheter 300 can be advanced through the lateral exit opening 214 to access the target tissue site. The puncture needle 400 can be advanced through the puncture needle exit opening 312 of the medical implant delivery catheter 300 to puncture tissue. The curve in the pre-formed curve 410 facilitates access to the target tissue site on the side of the lateral delivery catheter 200 when the puncture needle 400 is advanced through the puncture needle exit opening 312. This improved access of the puncture needle 400 to the target tissue site facing the side of the lateral delivery catheter 200 can provide effective tissue puncture. 【0059】 In one embodiment, the pre-formed curve 410 may have the same or similar orientation as the pre-formed curve 204 of the external delivery catheter 200. In one embodiment, the pre-formed curve 410 may have the same or similar orientation as the pre-formed curve 304 of the medical implant delivery catheter 300. In one embodiment, the pre-formed curve 410 may have a radius of curvature smaller than that of the pre-formed curve 304. 【0060】 In one embodiment, the medical implant delivery catheter 300 may be pre-assembled into the medical implant delivery lumen of the outer delivery catheter 200. The pre-assembled medical implant delivery catheter 300 can remain within the outer delivery catheter 200 until the outer delivery catheter 200 is positioned at or near the target tissue site. For example, the distal end 310 of the medical implant delivery catheter 300 may remain within the medical implant delivery lumen and not extend beyond the lateral exit opening 214 until the outer delivery catheter 200 is positioned within the desired blood vessel, passage, chamber, and / or organ. The distal end 310 of the medical implant delivery catheter 300 may not extend beyond the lateral exit opening 214 while the medical implant delivery catheter 300 is in a retracted configuration. In the retracted configuration, the distal end 310 may be positioned proximal to, on, or distal to the lateral exit opening 214. As described herein, the distal end 310 of the medical implant delivery catheter 300 may be pre-assembled and positioned adjacent to the lateral outlet opening 214 and proximal to the lateral outlet opening 214. In some embodiments, the distal end 310 of the medical implant delivery catheter 300 may be pre-assembled and positioned adjacent to the lateral outlet opening 214 and distal to the lateral outlet opening 214. In some embodiments, the medical implant delivery catheter 300 may not be pre-assembled and may be advanced from the proximal end of the lateral delivery catheter 200 to the lateral outlet opening 214 after the lateral delivery catheter 200 has been positioned in the desired blood vessel, passage, chamber, and / or organ. 【0061】 In one embodiment, the puncture needle 400 may be pre-assembled into the puncture needle lumen of the medical implant delivery catheter 300. In one embodiment, the puncture needle 400 may remain within the medical implant delivery catheter 300 until the outer delivery catheter 200 is positioned at or near the target tissue site. For example, the puncture component 408 may be prevented from extending beyond the puncture needle exit opening 312 until the outer delivery catheter 200 is positioned within a blood vessel, passage, chamber, and / or organ. The puncture component 408 may remain within the medical implant delivery catheter 300 while the puncture needle is in a retracted configuration. In one embodiment, while the puncture needle 400 is in a retracted configuration, a portion of the puncture needle 400 may extend through the puncture needle exit opening 312, but a portion of the puncture needle 400 may remain within the outer delivery catheter 200. For example, the puncture component 408 may extend through the puncture needle exit opening 312 while the puncture needle 400 is in a retracted configuration. The puncture component 408 extending beyond the puncture needle exit opening 312 may be located within the medical implant delivery lumen of the outer delivery catheter 200 until the outer delivery catheter 200 is positioned in the desired vessel, passage, chamber, and / or organ, including after the lateral exit opening 214 is positioned in the desired location within the vessel, passage, chamber, and / or organ. In some embodiments, the puncture needle 400 may not be pre-assembled and may be advanced from the proximal portion of the medical implant delivery catheter 300 to the puncture needle exit opening 312 after the outer delivery catheter 200 has been positioned in the desired vessel, passage, chamber, and / or organ. 【0062】 In one embodiment, the distal portion 404 of the puncture needle 400 may include a shape memory material. As described herein, the distal portion 404 may remain in the medical implant delivery catheter 300 until the outer delivery catheter 200 is positioned at or near a target tissue site, such as the lateral exit opening 214 of the outer delivery catheter 200. While received in the medical implant delivery catheter, the distal portion 404 may have a configuration with a gentle curve. In one embodiment, the distal portion 404 may have a linear or substantially linear configuration while received in the medical implant delivery catheter. After the extension of the distal portion 404 through the puncture needle exit opening 312, the pre-formed curve 410 in the distal portion 404 may take on a curved configuration. After retraction back into the medical implant delivery catheter 300, the distal portion 404 may again take on a configuration with a gentle curve, including a linear or substantially linear configuration. 【0063】 In one embodiment, the medical implant delivery system 100 may include a radially expandable member (not shown) configured to be inserted into and expand an opening formed in tissue by a puncture needle 400. The expansion of the opening facilitates the positioning of a medical implant device 350 (not shown) into the opening. The radially expandable member may be associated with the distal portion of a puncture needle sheath (not shown). For example, the puncture needle sheath may extend through the puncture needle lumen of a medical implant delivery catheter 300, and the puncture needle 400 may extend through the puncture needle sheath. For example, at least a portion of the puncture needle 400 may extend within the puncture needle sheath, and at least a portion of the puncture needle sheath may extend within the medical implant delivery catheter 300. In one embodiment, the distal portion 302 of the medical implant delivery catheter 300 may be configured to provide a desired expansion of the opening. For example, the distal portion 302 may be inserted into the opening to expand it. The distal portion 302 may have a size and / or shape to facilitate the expansion of the opening, such as having a predetermined diameter configured to provide a desired expansion. In some embodiments, both the radially expandable member and the distal portion 302 may be used to expand the opening. For example, the radially expandable member may be used to provide an initial expansion of the opening and to facilitate the insertion of the distal portion 302 into the opening to provide any desired remaining expansion of the opening. 【0064】 In one embodiment, the puncture needle 400 can be replaced with a medical implant guide wire configured to be inserted through an opening formed in the target tissue site to guide the deployment of the medical implant device 350. For example, the puncture needle 400 can be retracted, and the medical implant guide wire can be advanced through the puncture needle lumen or puncture needle sheath extending through the puncture needle lumen. The medical implant delivery catheter 300 can be advanced along the medical implant guide wire so that the distal portion 302 of the medical implant delivery catheter 300 can be inserted through the opening and the medical implant device 350 can be positioned in the opening. In one embodiment, the puncture needle 400 can be advanced further into the opening after the opening has been formed to guide the subsequent advance of the medical implant delivery catheter 300, rather than the guide wire. The medical implant delivery catheter 300 can be advanced along the puncture needle 400 so that the medical implant device 350 can be positioned in the opening. 【0065】 Figure 5 is a side view of the distal portion 202 of the external delivery catheter 200. The guide wire exit opening 212 may be associated with the distal end 210 of the external delivery catheter 200. For example, the guide wire exit opening 212 may be located at the distal end 210. As described herein, the guide wire 50 may extend through the guide wire lumen of the external delivery catheter 200. The guide wire lumen may extend along the length of the external delivery catheter 200 so that the external delivery catheter 200 can be guided along the guide wire 50 to advance the external delivery catheter 200 to a desired location in a blood vessel, passage, chamber, and / or organ. In some embodiments, the guide wire lumen may extend along the entire length or substantially the entire length of the external delivery catheter 200. For example, the guide wire 50 may extend along the entire length or substantially the entire length of the external delivery catheter 200 and exit through the guide wire exit opening 212 at the distal end 210. 【0066】 The lateral exit opening 214 may be located in the distal portion 202 of the external delivery catheter 200. As described herein, the distal portion 202 of the external delivery catheter 200 may be provided with a pre-formed curve 204. The lateral exit opening 214 may be located on the pre-formed curve 204, for example, on the inner edge 206 of the pre-formed curve 204. For example, after the external delivery catheter 200 has been advanced to a desired location in a desired blood vessel, passage, chamber, and / or organ, the inner edge 206 can be oriented toward the target tissue site, thereby oriented the lateral exit opening 214 toward the target tissue, so that the medical implant delivery catheter 300 can be extended toward the target tissue site through the lateral exit opening 214. The puncture needle 400 can be deployed to make contact with the tissue at the target tissue site. The outer edge 208 of the pre-formed curve 204 may be oriented toward a location opposite to the target tissue site, or otherwise oriented toward a location opposite to the target tissue site. 【0067】 In some embodiments, the distal portion 202 may be tapered. The size of the distal portion 202 can be tapered towards the distal end 210. For example, the diameter of the external delivery catheter 200 may be tapered towards the distal end 210. The tapering in the distal portion 202 and / or pre-formed curve 204 may be configured to facilitate the positioning of the external delivery catheter 200 to a blood vessel, passage, chamber, and / or organ. In some embodiments, the radius of curvature and / or length of the pre-formed curve 204 may be selected at least in part based on the shape and / or dimensions of a desired blood vessel, passage, chamber, and / or organ. In some embodiments, the medical implant delivery system 100 may be configured to be positioned within the coronary sinus. As further described herein, the medical implant delivery system 100 may be positioned into the coronary sinus via the coronary sinus hilum. The external delivery catheter 200 may be positioned within the coronary sinus to access a site in the left atrial wall accessible from within the coronary sinus. The tapering at the distal portion 202 facilitates insertion into narrower portions of the coronary sinus. The length of the pre-formed curve 204 may be selected at least partially based on the distance of the target tissue site from the coronary sinus hilum. The radius of curvature of the pre-formed curve 204 may be selected at least partially based on the shape of the coronary sinus, including the degree of curvature of the coronary sinus in which the lateral delivery catheter 200 is positioned. The radius of curvature of the pre-formed curve 204 may be selected so that the pre-formed curve 204 can match or substantially match the curvature of the adjacent coronary sinus curve in which the lateral delivery catheter 200 is positioned. The pre-formed curve 204 may be positioned such that its medial edge 206 is oriented toward a portion of the left atrial wall, and its lateral edge 208 is oriented toward a portion of the coronary sinus wall, such as the opposite portion of the coronary sinus wall. For example, the pre-formed curve 204 can follow a curve, or can substantially follow a curve. In one embodiment, the distal portion 202 of the external delivery catheter 200 may include a shape memory material. For example, a pre-formed curve 204 is curved after the external delivery catheter 200 has been advanced into the coronary sinus. You can take it. 【0068】 Figure 6 is a side view of the distal portion 302 of the medical implant delivery catheter 300 and the puncture needle 400 extending through a puncture needle exit opening 312 associated with the distal end 310 of the medical implant delivery catheter 300. The medical implant delivery catheter 300 may have a pre-formed curve 304 in the distal portion 302. The pre-formed curve 304 may have the same or similar orientation as the pre-formed curve 204 of the lateral delivery catheter 200. For example, when the medical implant delivery catheter 300 is positioned in the coronary sinus, the inner edge 306 of the pre-formed curve 304 may be oriented toward the left atrial wall, and the outer edge 308 of the pre-formed curve 304 may be oriented toward the opposite portion of the coronary sinus wall. In some embodiments, the pre-formed curve 304 may have a smaller radius of curvature than the pre-formed curve 204. 【0069】 The medical implant device 350 may be supported by a medical implant delivery catheter 300. Referring to Figure 6, in one embodiment, the medical implant device 350 may be positioned on a pre-formed curve 304. The medical implant device 350 may be circumferentially positioned around the distal portion 302, including on the pre-formed curve 304 of the pre-formed curve. In one embodiment, the medical implant device 350 may include a shunt device, including an expandable shunt device. For example, the expandable shunt device may be configured for delivery to the left atrial wall to address elevated left atrial pressure. The expandable shunt device may be positioned around a portion of the distal portion 302, such as around a portion of the pre-formed curve 304 of the distal portion 302. 【0070】 An expandable shunt device may have several configurations. In one embodiment, the expandable shunt device may comprise an expandable tubular shunt device. An example of a suitable expandable shunt device for a medical implant delivery system 100 is provided in U.S. Patent Application No. 15 / 335,891, entitled "Systems for Deploying an Expandable Cardiac Shunt," which is incorporated herein in its entirety. 【0071】 The pre-formed curve 304 can facilitate the assessment of the target tissue site while the medical implant delivery system 100 is positioned in a blood vessel, passage, chamber, and / or organ. For example, the pre-formed curve 304 can facilitate the proper positioning of the puncture needle 400 at the target tissue site when the medical implant delivery catheter 300 is extended through the lateral exit opening 214 of the outer delivery catheter 200. As described herein, the target tissue site may face the side of the outer delivery catheter 200 (e.g., proximal to the lateral exit opening 214). The curve of the distal portion 302 of the implant delivery catheter 300 facilitates access to the target tissue site on the side of the delivery catheter 200 when the distal portion 302 is advanced through the lateral exit opening 214, thereby facilitating the proper positioning of the puncture needle 400. Proper positioning of the puncture needle 400 can enable effective puncture of the target tissue site. 【0072】 In some embodiments, the distal portion 302 may be tapered. The size of the distal portion 302 can be tapered towards the distal end 310. For example, the diameter of the medical implant delivery catheter 300 may be tapered towards the distal end 310. In some embodiments, the tapering and / or pre-formed curvature 304 of the distal portion 302 can facilitate the desired deployment of the medical implant device 350 into the target tissue site. As described in further detail herein, the distal portion 302 may be further extended through an opening formed in the target tissue site so that the medical implant device 350 can be positioned and deployed within the opening. The tapering in the distal portion 302 can facilitate the insertion of the distal portion 302 through the opening formed in the tissue. When the distal portion 302 is extended through the lateral exit opening 214 of the external delivery catheter 200 to access a target site facing the side of the external delivery catheter 200, and so that the distal portion 302 can be inserted into the opening, the pre-formed curve 304 allows the distal portion 302 to follow a predetermined trajectory. 【0073】 In one embodiment, the distal portion 302 of the medical implant delivery catheter 300 may include a shape memory material. As described herein, the distal portion 302 may remain within the outer delivery catheter 200 until the outer delivery catheter 200 is positioned at or near a target tissue site. While retracted within the outer delivery catheter, the pre-formed curve 304 of the distal portion 302 may have a configuration having a gentle curve relative to its relaxed state, such as when it is extended through the lateral exit opening 214. In one embodiment, the distal portion 302 may have a linear or substantially linear configuration while received within the outer delivery catheter 200. After extension of the distal portion 302 through the lateral exit opening 214, the pre-formed curve 304 in the distal portion 302 may take on a curved configuration. After retraction back into the outer delivery catheter 200, the pre-formed curve 304 may again take on a gentle curve configuration, including a linear or substantially linear configuration. In one embodiment, the external delivery catheter 200, the medical implant delivery catheter 300, and / or the puncture needle 400 may be flexible so that they can conform to the shape of the anatomical pathway as the medical implant delivery system 100 is advanced through a winding path. 【0074】 Figure 7 is a perspective view of an example of a proximal handle 500 of a medical implant delivery system 100. The proximal handle 500 may be configured to provide control for the deployment of the medical implant delivery system 100. The proximal handle 500 may include control mechanisms for both puncturing tissue at a target tissue site using a puncture needle 400 and deploying a medical implant device 350 positioned on a medical implant delivery catheter 300. The use of a single proximal handle for both tissue puncture and medical implant device deployment simplifies the process for the operator and thereby facilitates shortening the procedure. 【0075】 The advancement device 502 in the proximal handle 500 may be configured to translate proximal and / or distally through the posterior bracket 504. The advancement and / or retraction of the medical implant delivery catheter 300 and the lateral delivery catheter 200 may be controlled by the advancement device 502. For example, the advancement device 502 may be translated distally to advance the medical implant delivery catheter 300 and the lateral delivery catheter 200. The medical implant delivery catheter 300 and the lateral delivery catheter 200 may extend through a locking nut 506. The locking nut 506 may be fixed to the anterior bracket 508 so that the advancement device 502, the medical implant delivery catheter 300, and the lateral delivery catheter 200 can be fixed to the proximal handle 500. The proximal handle 500 may include a pair of flexible arms 510 configured to allow controlled deployment of the medical implant device 350. For example, a pair of flexible arms 510 may be used to initiate and / or operate the controlled release of a medical implant device 350 from a medical implant delivery catheter 300 to an opening formed in a target tissue site. 【0076】 Figures 8A and 8B show longitudinal cross-sectional views of the medical implant delivery system 100 in a first and second configuration, respectively. The longitudinal cross-sectional view may include a cross-sectional view of the outer delivery catheter 200 along its longitudinal axis. The distal portion 302 of the medical implant delivery catheter 300 is shown as being received within the medical implant delivery lumen of the outer delivery catheter 200. A guide wire 50 may extend through the guide wire lumen 220 of the outer delivery catheter 200. The medical implant device 350 may be positioned at the distal portion 302 of the medical implant delivery catheter 300. The expandable anchoring portion 250 is shown in the expanded state in Figures 8A and 8B. As described herein, the medical implant delivery catheter 300 may be pre-assembled into the outer delivery catheter 200 so that it can be advanced together with the outer delivery catheter 200 into a desired blood vessel, passage, chamber, and / or organ. Figure 8A shows the medical implant delivery catheter 300 pre-assembled in a first retraction configuration, and Figure 8B shows the medical implant delivery catheter 300 pre-assembled in a second retraction configuration. As shown in Figure 8A, in the first retraction configuration, the distal end 310 of the medical implant delivery catheter 300 is distal to the lateral exit opening 214. Before deploying the medical implant delivery catheter 300, for example, while advancing the lateral delivery catheter 200 along the guide wire 50 to a desired location, the distal end 310 may be distal to the lateral exit opening 214. In some embodiments, the distal end 310 may be adjacent to the lateral exit opening 214 distally (for example, adjacent to and in contact with the lateral exit opening 214). The medical implant delivery catheter 300 may be translated proximal to the lateral delivery catheter 200 in order to extend its distal end 310 through the lateral exit opening 214 toward deployment of the medical implant delivery catheter 300. Referring to Figure 8B, the distal end 310 of the medical implant delivery catheter 300 may be positioned proximal to the lateral exit opening 214.In one embodiment, the distal end 310 may be adjacent to the lateral outlet opening 214 proximal to the lateral outlet opening 214 (for example, it may be adjacent to and in contact with the lateral outlet opening 214). To deploy the medical implant delivery catheter 300, the medical implant delivery catheter 300 may be translated distally to the lateral delivery catheter 200. The distal end 310 may be adjacent to the lateral outlet opening 214 to shorten or minimize the distance required to advance or retract the medical implant delivery catheter 300 for deployment. 【0077】 In one embodiment, the guide wire lumen of the outer delivery catheter 200 may extend along an off-center longitudinal axis. Referring to Figure 9, a cross-sectional view of the outer delivery catheter 200 is shown. The cross-section may be cut along a plane that is perpendicular or substantially perpendicular to the longitudinal axis of the outer delivery catheter 200. The cross-section may include the width of the outer delivery catheter 200. As shown, the guide wire lumen 220 may extend off-center from the central longitudinal axis (C) of the outer delivery catheter 200. Thereafter, a medical implant delivery catheter 300 (not shown) may be advanced through the outer delivery catheter 200 off-center from the central longitudinal axis (C). For example, the medical implant delivery lumen may be off-center from the central longitudinal axis (C). The off-center guide wire lumen 220 can reduce or prevent axial rotation of the medical implant delivery catheter 300 while positioning the medical implant delivery catheter 300 within the lumen 220. For example, by advancing the medical implant delivery catheter 300 along a path offset from the central longitudinal axis (C), it is possible to easily maintain the axial rotation orientation of the medical implant delivery catheter 300 while it is extended through a winding anatomical path. Maintaining the desired rotation orientation of the medical implant delivery catheter 300 facilitates the desired exit trajectory of the medical implant delivery catheter 300 when it is extended through the lateral exit opening 214 (not shown). Maintaining the desired exit trajectory of the medical implant delivery catheter 300 facilitates effective tissue puncture at the target tissue site using a puncture needle 400 (not shown). 【0078】 Figures 10A to 10D show another example of the medical implant delivery system 1000. The medical implant delivery system 1000 may comprise an external delivery catheter 1100 and a medical implant delivery catheter 1200. At least a portion of the medical implant delivery catheter 1200 may be slidably received within the external delivery catheter 1100. In one embodiment, at least a portion of the medical implant delivery catheter 1200 may be passed through at least a portion of the external delivery catheter 1100. Figure 10A shows a top view of the external delivery catheter 1100, and Figure 10B shows a lateral cross-sectional view of the external delivery catheter 1100. Figure 10C shows a top view of the medical implant delivery catheter 1200, and Figure 10D shows a side view of the medical implant delivery catheter 1200. A puncture needle (not shown) may be slidably received within the medical implant delivery catheter 1200. The puncture needle may be configured to extend through a puncture needle exit opening 1212 associated with the distal portion 1202 of the medical implant delivery catheter 1200, including its distal end 1210. In one embodiment, at least a portion of the puncture needle may pass through at least a portion of the medical implant delivery catheter 1200 and extend through the puncture needle exit opening 1212. 【0079】 In one embodiment, the medical implant delivery catheter 1200 may be pre-assembled within the external delivery catheter 1100. In another embodiment, the puncture needle may be pre-assembled within the medical implant delivery catheter 1200. The medical implant delivery system 1000 may or may not be used in combination with a puncture needle sheath. For example, the puncture needle sheath may extend slidably within the puncture needle lumen of the medical implant delivery catheter 1200, and the puncture needle may extend slidably within the lumen of the puncture needle sheath. The puncture needle may be pre-assembled within the puncture needle sheath, and the puncture needle sheath may be pre-assembled within the medical implant delivery catheter 1200. Alternatively, the medical implant delivery catheter 1200, the puncture needle, and / or the puncture needle sheath may not be pre-assembled. 【0080】 The distal end 1102 of the external delivery catheter 1100 may be provided with a lateral exit opening 1114. Deployment of the medical implant delivery catheter 1200 may include extending the medical implant delivery catheter 1200 through the lateral exit opening 1114. The distal end 1102 may be provided with a pre-formed curve 1104. The pre-formed curve 1104 may be configured to facilitate the positioning of the external delivery catheter 1100 to a blood vessel, passage, chamber, and / or organ to access a target tissue site. The lateral exit opening 1114 may be located on the inner edge 1106 of the pre-formed curve 1104. The inner edge 1106 may be oriented toward the target tissue site, while the external delivery catheter 1100 is positioned at the target site in a desired orientation. The outer edge 1108 of the pre-formed curve 1104 may be oriented toward the target tissue site, such as toward a location opposite to the target tissue site. The distal portion 1202 of the medical implant delivery catheter 1200 may be provided with a pre-formed curve 1204. In some embodiments, the pre-formed curve 1204 may have the same orientation as the pre-formed curve 1104 when the medical implant delivery catheter 1200 is in an unfolded configuration, such as when the distal portion 1202 extends beyond the lateral exit opening 1114. The pre-formed curve 1204 may be configured to facilitate access to the target tissue site while the outer delivery catheter 1100 is positioned at the target location. In some embodiments, the outer delivery catheter 1100 and / or the medical implant delivery catheter 1200 may be flexible so that they can conform to the shape of the anatomical pathway when the medical implant delivery system 1000 is advanced through a winding path. In some embodiments, the medical implant delivery catheter 1200 may include a gently curved configuration while retracted into the outer delivery catheter 1100. In one embodiment, the medical implant delivery catheter 1200 may have a linear or substantially linear configuration while retracted into the outer delivery catheter 1100, and may adopt a curved configuration after being released from the outer delivery catheter 1100.In one embodiment, the medical implant delivery catheter 1200 and / or external delivery catheter 1100 may include shape memory material in the distal portions 1202, 1102, etc. 【0081】 The lateral outlet opening 1114 may have a shape to facilitate the extension of the medical implant delivery catheter 1200 through the lateral outlet opening 1114 in a desired orientation. For example, the distal portion 1202 of the medical implant delivery catheter 1200 may be configured to engage with the lateral outlet opening 1114 when the distal portion 1202 is extended through the lateral outlet opening 1114. In some embodiments, the lateral outlet opening 1114 may have asymmetry about its central axis. The asymmetry can reduce or prevent rotation of the distal portion 1202 when it is extended through the lateral outlet opening 1114. The distal portion 1202 may have a corresponding shape for engaging with the shape of the lateral outlet opening 1114. For example, the distal portion 1202 may be configured to engage with the asymmetry of the lateral outlet opening 1114 when at least a portion of the distal portion 1202 is advanced through the lateral outlet opening 1114. In one embodiment, the shape of the distal portion 1202 can be matched to the shape of the lateral outlet opening 1114, for example, being the same as or similar to it. The match between the distal portion 1202 and the lateral outlet opening 1114 can facilitate mutual locking between the two. 【0082】 The lateral outlet opening 1114 may comprise a proximal portion 1114a and a distal portion 1114b. The proximal portion 1114a and / or the distal portion 1114b may have a shape for interlocking with the distal portion 1202. In some embodiments, the distal portion 1114b may have a width narrower than the width of the proximal portion 1114a. In some embodiments, the distal portion 1114b may have an elongated extension. In some embodiments, the distal portion 1114b may have a "V" shape. In some embodiments, the proximal portion 1114a may have a circular portion. In some embodiments, the proximal portion 1114a may have an elliptical portion. 【0083】 In one embodiment, the distal portion 1202 of the medical implant delivery catheter 1200 may have a shape that interlocks with the shape of the lateral outlet opening 1114. The distal portion 1202 may have a cross section having a shape configured to interlock with the shape of the lateral outlet opening 1114, and the cross section may extend along the transverse dimension of the distal portion of the lateral delivery catheter 1100. In one embodiment, the shape of the cross section, such as the shape of the cross section of the distal portion 1202, may have a shape configured to interlock with the shape of the lateral outlet opening 1114 in order to orient the medical implant delivery catheter 1200 when it is extended through the lateral outlet opening 1114. The distal portion 1202 can be rotated before extending it through the lateral outlet opening 1114 in order to properly orient it toward the lateral outlet opening 1114, for example, so that the shape of the cross section of the distal portion 1202 matches the shape of the lateral outlet opening 1114. In one embodiment, the cross section can be cut along a plane that divides the medical implant delivery catheter 1200 into an upper and a lower portion, the upper portion having an inner edge 1206 of a pre-formed curve 1204, and the lower portion having an outer edge 1208 of a pre-formed curve 1204. The cross section can be cut along a cross-sectional plane that extends along the longitudinal axis of the medical implant delivery catheter 1200 and is parallel or substantially parallel to a plane that includes at least a portion of the lateral outlet opening 1114. For example, the cross section can divide the medical implant delivery catheter 1200 into an upper and a lower portion. For example, the distal portion 1202 may have a slender distal end 1214. The slender distal end 1214 can be oriented toward the distal portion 1114b of the lateral outlet opening 1114 and / or aligned with the distal portion 1114b of the lateral outlet opening 1114 so as to guide the orientation of the medical implant delivery catheter 1200 when the medical implant delivery catheter 1200 is extended through the lateral outlet opening 1114. For example, interlocking the distal portion 1202 with the lateral outlet opening 1114 can allow the inner edge 1206 of the pre-formed curve 1204 to be oriented proximal and the outer edge 1208 of the pre-formed curve 1204 to be oriented distally when the distal portion 1202 is deployed. 【0084】 The medical implant delivery system 1000 may have the same or similar features as those of the medical implant delivery system 100, as described with reference to Figures 3 to 9. For example, a puncture needle (not shown) may be received in the puncture needle lumen of the medical implant delivery catheter 1200. The puncture needle may be extended through a puncture needle exit opening 1212 associated with the distal end 1210 of the medical implant delivery catheter 1200 to puncture tissue at a target tissue site. The medical implant device 1250 may be positioned distally 1202 such that the delivery catheter for delivering the puncture needle does not need to be replaced with a delivery catheter for delivering the medical implant device 1250. The medical implant device 1250 may be deployed to the tissue opening formed by the puncture needle. The external delivery catheter 1100 may include a guide wire lumen 1120 configured to receive a guide wire. A guide wire may extend through a guide wire exit opening 1112 associated with the distal end 1110 of the outer delivery catheter, so that the outer delivery catheter 1100 can be advanced along the guide wire for positioning to a desired blood vessel, passage, ventricle, and / or organ. For example, a medical implant delivery system 1000 may be configured for positioning from the right atrium to the coronary sinus via the coronary sinus hilum, so that a puncture needle extending through a medical implant delivery catheter 1200 can be used to form an opening in a portion of the left atrial wall accessible from within the coronary sinus. The medical implant device 1250 may be a shunt device. The shunt device can be deployed to an opening to treat elevated atrial pressure. The medical implant delivery catheter 1200 can be further advanced into an opening formed in the left atrial wall so that the medical implant device 1250 can be positioned into the opening. 【0085】 Figures 11–16 illustrate various steps of an example of the process for deploying a medical implant device 350 using a medical implant delivery system 100 as described herein. Referring to Figure 11, the guide wire 50 can be inserted from the right atrium 5 through the coronary sinus hilum 17 into the coronary sinus 18. The right atrium 5 can be accessed via the superior vena cava or the inferior vena cava. For example, a transcervical or transclavicular technique can be used to access the right atrium 5 via the superior vena cava. The medical implant delivery system 100 can be inserted into the subclavian or jugular vein and advanced into the superior vena cava. Alternatively, a transfemoral technique can be used to position the medical implant delivery system 100 into the inferior vena cava. 【0086】 As shown in Figure 12, the medical implant delivery system 100 can be advanced along the guide wire 50 into the coronary sinus 18. The medical implant delivery system 100 can be advanced along the guide wire 50 until it reaches a desired location relative to the left atrial wall. For example, the lateral delivery catheter 200 can be advanced along the guide wire 50 to position its lateral outlet opening 214 at or near the target tissue site in the left atrial wall. The pre-formed curve 204 of the lateral delivery catheter 200 can be positioned to follow the curvature of the coronary sinus 18. For example, the pre-formed curve 204 can be positioned such that its inner edge 206 is oriented toward a portion of the left atrial wall and its outer edge 208 is oriented toward the opposite portion of the wall of the coronary sinus 18. 【0087】 As described herein, in one embodiment, the medical implant delivery system 100 may have an expandable anchoring portion 250 on the outer edge 208 of the curve 204. After the outer delivery catheter 200 is positioned in the desired location, the expandable anchoring portion 250 may be activated and / or actuated to take an expanded configuration. In the expanded configuration, the expandable anchoring portion 250 may contact the wall of the coronary sinus 18 to push the outer delivery catheter 200 toward the left atrial wall. For example, the expandable anchoring portion 250 may contact the wall of the coronary sinus 18 so that the outer delivery catheter 200 can be positioned against the wall of the left atrium 2, thereby facilitating the stable positioning of the medical implant delivery system 100 in the desired location. In one embodiment, the inner edge 206 of the pre-formed curve 204 may contact the left atrial wall so that the lateral outlet opening 214 is positioned in and / or around the target tissue site. In one embodiment, the inner edge 206 does not need to be in contact with the left atrial wall while the expandable anchoring portion 250 is in an expanded state. 【0088】 As shown in Figure 12, the medical implant delivery catheter 300 can be pre-assembled into the medical implant delivery catheter lumen of the outer delivery catheter 200, and the puncture needle 400 can be pre-assembled into the puncture needle lumen of the medical implant delivery catheter 300. While the outer delivery catheter 200 is advanced to the desired location, the medical implant delivery catheter 300 can be received into the medical implant delivery catheter lumen of the outer delivery catheter 200. For example, the distal end 310 of the medical implant delivery catheter 300 can be received into the medical implant delivery catheter lumen while the outer delivery catheter 200 is advanced to the desired location. The puncture needle 400 can be pre-assembled into the puncture needle lumen of the medical implant delivery catheter 300 so that the puncture component 408 is positioned within the puncture needle lumen, or alternatively, so that the puncture component 408 extends through a puncture needle exit opening 312 associated with the distal end 310 of the medical implant delivery catheter 300. While being advanced towards the target tissue site, the puncture component 408 can extend through the puncture needle exit opening 312 and remain within the medical implant delivery catheter lumen of the external delivery catheter 200. 【0089】 Referring to Figure 13, after the external delivery catheter 200 is positioned in the desired location, the medical implant delivery catheter 300 may be extended through the lateral exit opening 214. After the external delivery catheter 200 is positioned in the desired location, the distal portion 302 of the medical implant delivery catheter 300, including the distal end 310, may be extended through the lateral exit opening 214. In one embodiment, the distal portion 302 may be rotated to properly orient the distal portion 302 with respect to the lateral exit opening 214 before extending the distal portion 302 through the lateral exit opening. 【0090】 As described herein, the puncture needle 400 can be pre-assembled within the puncture needle lumen of the medical implant delivery catheter 300. The puncture needle can be pre-assembled such that the puncture component 408 is associated with the distal end 310 and extends through the puncture needle exit opening 312. The implant delivery catheter 300 may be extended through a lateral exit opening 214 so that the puncture component 408 can be used to contact the wall of the left atrium 2 and puncture the tissue. In some embodiments, the puncture needle 400 may be further extended to complete the formation of the opening. In some embodiments, the puncture component 408 may be received within the puncture needle lumen of the implant delivery catheter 300 while the lateral delivery catheter 200 is inserted into the desired location. The puncture component 408 may be substantially extended through the puncture needle exit opening 312 so that it can be used to contact the target tissue site. 【0091】 The pre-formed curve 304 (not shown) of the medical implant delivery catheter 300 can provide a desired trajectory for the distal portion 302 (not shown) of the medical implant delivery catheter 300 when advanced through the lateral exit opening 214. For example, the pre-formed curve 304 can facilitate contact between the puncture needle 400 and the target tissue site in the left atrial wall when positioned laterally to the medical implant delivery system 100. The pre-formed curve 304 can facilitate the subsequent insertion of the distal portion 302 into the opening formed in the target tissue site. The pre-formed curve 410 (not shown) of the puncture needle 400 facilitates the insertion of the distal portion 404 (not shown) of the puncture needle 400 into the tissue at the target tissue site, thereby providing effective puncture of the tissue at the target site when positioned laterally to the medical implant delivery system 100. 【0092】 As described herein, the expandable anchoring portion 250 can take on an expanded configuration after the external delivery catheter 200 has been positioned in a desired location within the coronary sinus 18. In some embodiments, expansion of the expandable anchoring portion 250 can facilitate reliable positioning of the external delivery catheter 200 against the wall of the coronary sinus. In some embodiments, the external delivery catheter 200 may be pushed toward the left atrial wall, for example, so that the inner edge 206 of a pre-formed curve 204 contacts the left atrial wall. In some embodiments, positioning of the external delivery catheter 200 against the left atrial wall can facilitate tissue puncture using the puncture component 408 when the puncture needle 400 is extended through the lateral exit opening 214. In some embodiments, the medical implant delivery system 100 may not have an expandable anchoring portion 250 and / or the inner edge 206 is not positioned in contact with the left atrial wall. For example, the puncture needle 400 can be advanced further through the lateral exit opening 214, compared to the degree to which the puncture needle 400 can be advanced when the expandable anchoring portion 250 is used, so that the puncture component 408 can contact and press against the left atrial wall, thereby perforating the tissue at the target tissue site. 【0093】 In one embodiment, the medical implant delivery system 100 may comprise a puncture needle sheath. A puncture needle 400 may extend along the puncture needle lumen of the puncture needle sheath. The puncture needle sheath may be received within a medical implant delivery catheter 300. For example, at least a portion of the puncture needle sheath may be configured to pass through at least a portion of the puncture needle lumen of the medical implant delivery catheter 300, and at least a portion of the puncture needle 400 may pass through at least a portion of the lumen of the puncture needle sheath. In one embodiment, the medical implant delivery system 100 may comprise a radially expandable member associated with the distal portion of the puncture needle sheath, the radially expandable member being configured to enlarge an opening formed in tissue. The distal portion of the puncture needle sheath can be advanced through the opening so that at least a portion of the radially expandable member is positioned within the opening. Subsequently, the radially expandable member may be activated and / or actuated to take an expansion configuration to provide a desired enlargement of the opening. The radially expandable member can be deflated and retracted from the opening after the desired expansion has been achieved. In one embodiment, the distal portion 302 of the medical implant delivery catheter 300 can be inserted into the opening to expand it, for example, without using a radially expandable member associated with a puncture needle sheath. In one embodiment, both the radially expandable member and the distal portion 302 of the medical implant delivery catheter 300 can be used to expand the opening. 【0094】 Referring to Figure 14, as described herein, in one embodiment, the puncture needle 400 may extend into the left atrium 2 to serve as a guide wire that can be advanced along the medical implant delivery catheter 300 to deploy the medical implant device 350. Alternatively, the puncture needle 400 may be retracted after an opening has been formed in the left atrial wall. The puncture needle 400 can be replaced with a medical implant guide wire. The medical implant guide wire can be advanced into the left atrium 2 through the puncture needle lumen of the medical implant delivery catheter 300. In one embodiment, the medical implant guide wire can be advanced through a puncture needle sheath extending through the puncture needle lumen. In one embodiment, the puncture needle 400 may be replaced with a medical implant guide wire before or after the desired enlargement of the opening in the left atrial wall has been achieved. For example, the puncture needle 400 may be retracted, and the medical implant guide wire may be inserted into its predetermined position before the radially expandable anchoring portion is activated and / or activated. 【0095】 Figure 15 shows the deployment of the medical implant device 350. The medical implant delivery catheter 300, including its distal portion 302, can be advanced through an opening in the left atrial wall so that the medical implant device 350 can be positioned at the opening. The medical implant delivery catheter 300 is shown being advanced along a puncture needle 400 extended into the left atrium 2. As described herein, the medical implant device 350 may include an expandable shunt device. The expandable shunt device can be positioned at an opening to shunt blood flow from the left atrium 2 to the coronary sinus 18 to alleviate elevated left atrial pressure. An example of the process for deploying the expandable shunt device into the left atrial wall is provided in U.S. Patent Application No. 15 / 335,891, entitled "Systems for Deploying an Expandable Cardiac Shunt," which is incorporated herein in its entirety. 【0096】 Figure 16 shows the retraction of the medical implant delivery system 100 from the coronary sinus 18 along the guide wire 50 after the medical implant device 350 has been positioned at an opening in the left atrial wall. As described herein, the medical implant device 350 may include an expandable shunt device. Referring to Figure 16, the expandable shunt device deployed at an opening formed in the left atrial wall can enable blood flow from the left atrium 2 to the coronary sinus 18. The blood flow can then flow out into the right atrium 5. Thus, creating a blood flow pathway from the left atrium 2 to the coronary sinus 18 can reduce elevated left atrial pressure. After the expandable shunt device has been deployed at the left atrial wall, the puncture needle 400 (not shown) and the medical implant delivery catheter 300 (not shown) can be retracted to return to the external delivery catheter 200. For example, the puncture needle 400 can be retracted to return to the puncture needle lumen of the medical implant delivery catheter 300, and the medical implant delivery catheter 300 can be retracted to return to the lateral delivery catheter 200. The expandable anchoring portion 250 can be in a collapsed and / or condensed state before being retracted from the coronary sinus 18. Alternatively, if a medical implant guide wire is used, the medical implant guide wire can be retracted. Subsequently, the lateral delivery catheter 200 can be retracted out of the coronary sinus along the guide wire 50. 【0097】 Figure 17 is a flowchart of an example of process 1600 for deploying a medical implant delivery system to deliver a medical implant device. The medical implant delivery system may have one or more features as described herein. The medical implant delivery system may comprise an external delivery catheter and a medical implant delivery catheter configured to extend through the lumen of the external delivery catheter. The medical implant delivery system may comprise a puncture needle extending through the lumen of the medical implant delivery catheter. In block 1602, process 1600 may include advancing the medical implant delivery system along a guide wire into a blood vessel, passage, chamber, and / or organ. For example, the medical implant delivery system may be positioned into the coronary sinus. The guide wire can be advanced into the coronary sinus, and the medical implant delivery system can be advanced into the coronary sinus along the already positioned guide wire. The external delivery catheter may comprise a guide wire lumen, and the guide wire may extend slidably through the guide wire lumen. 【0098】 In block 1604, process 1600 may include advancing the medical implant delivery catheter through the lateral outlet opening of the lateral delivery catheter. After the medical implant delivery system is positioned at a desired location within the coronary sinus, the medical implant delivery catheter may be deployed. For example, the medical implant delivery catheter may be extended through the lateral outlet opening of the lateral delivery catheter so that a puncture needle can be used to perforate the tissue at the target tissue site. In block 1606, process 1600 may include extending a puncture component through the distal outlet opening of the medical implant delivery catheter to perforate the tissue at the target tissue site and form an opening in the tissue. The target tissue site may be a portion of the left atrial wall accessible from within the coronary sinus. 【0099】 In block 1608, process 1600 may include extending the distal portion of a medical implant delivery catheter through an opening formed in the tissue. The distal portion can be advanced through the opening to position the medical implant device in the opening. In one embodiment, the distal portion may be configured to enlarge the opening in the tissue. The distal portion may have a predetermined diameter to provide a desired enlargement of the opening. In one embodiment, the medical implant delivery system may include a puncture needle sheath configured to slide through the puncture needle lumen of the medical implant delivery catheter, the puncture needle configured to slide through the lumen of the puncture needle sheath. A radially expandable member may be associated with the distal portion of the puncture needle sheath. The radially expandable member may be positioned within an opening formed in the wall of the target tissue site to enlarge the opening when the radially expandable member is in an expanded configuration. 【0100】 In block 1610, process 1600 may include deploying a medical implant device positioned in a medical implant delivery catheter into an opening formed in the tissue. For example, an expandable shunt device may be deployed into an opening formed in the left atrial wall. 【0101】 Figures 18–20 show side views of another example of the medical implant delivery system 1700. Referring to Figure 18, the medical implant delivery system 1700 may comprise an elongated housing 1800, a medical implant delivery catheter 1900 extending alongside the elongated housing 1800, and an outer sheath 2200 around the elongated housing 1800 and the medical implant delivery catheter 1900. A puncture needle sheath 2100 may extend slidably through the puncture needle lumen of the medical implant delivery catheter 1900. A puncture needle 2000 may extend slidably through the puncture needle sheath 2100. In one embodiment, the puncture needle 2000 may extend through the puncture needle lumen of the medical implant delivery catheter 1900 without the puncture needle sheath 2100. 【0102】 The medical implant device 1950 can be positioned on the medical implant delivery catheter 1900. The medical implant device 1950 can be positioned on the medical implant delivery catheter 1900 such that the delivery catheter for delivering the puncture needle does not need to be replaced with a delivery catheter for delivering the medical implant device 1950. In one embodiment, positioning the medical implant delivery catheter 1900 alongside the elongated housing 1800, rather than extending the medical implant delivery catheter 1900 through the outer delivery catheter, can provide improved maneuverability when deploying the medical implant delivery catheter 1900. The medical implant delivery catheter 1900 can be guided along tighter curves when deployed, for example, to facilitate improved access to the target tissue site. The ability to advance the medical implant delivery catheter 1900 toward and / or toward an opening formed in the target tissue without having to extend the medical implant delivery catheter 1900 through the lateral exit opening of the outer delivery catheter can facilitate guidance through tighter curves. This allows guidance through tighter curves to improve access to the target tissue site. For example, the ability to guide through narrower curves can enable controlled puncture of the target tissue and / or delivery of the medical implant device 1950 in patients with smaller and / or narrower anatomical features in and / or near the target tissue site. 【0103】 The elongated housing 1800 and the medical implant delivery catheter 1900 can be positioned to slide alongside each other. For example, the medical implant delivery catheter 1900 can be translated proximal and / or distal to the elongated housing 1800. In one embodiment, the elongated housing 1800 and the medical implant delivery catheter 1900 can be adjacent to and in contact with each other. The outer sheath 2200 may be around the elongated housing 1800 and the medical implant delivery catheter 1900 to maintain their positions side by side. 【0104】 The medical implant delivery system 1700 can be advanced along the guide wire 50 to a target location and / or retracted from the target location. For example, an elongated housing 1800 may include a guide wire lumen extending through itself and configured to receive the guide wire 50. In one embodiment, the guide wire lumen may extend along the entire length of the elongated housing 1800 and may extend through a guide wire exit opening 1812 associated with the distal end 1810 of the elongated housing 1800. 【0105】 In Figure 18, the outer sheath 2200 is shown positioned proximal to the medical implant device 1950. For example, the distal end 2202 of the outer sheath 2200 is shown proximal to the medical implant device 1950. As described herein, the distal end 2202 may be positioned distal to the medical implant device 1950, such as while the medical implant delivery system 1700 is advanced to the target location. In some embodiments, the outer sheath 2200 may cover and maintain the medical implant device 1950 before the deployment of the medical implant delivery catheter 1900 and / or the medical implant device 1950. The outer sheath 2200 may be slidable relative to the elongated housing 1800 and the medical implant delivery catheter 1900. The outer sheath 2200 may be translated proximal and / or distally relative to the medical implant delivery catheter 1900 and the elongated housing 1800. For example, the outer sheath 2200 can be translated proximal to the medical implant delivery catheter 1900 and the elongated housing 1800 to facilitate the release of the corresponding portion of the medical implant delivery catheter 1900 from being positioned adjacent to the elongated housing 1800. In one embodiment, after delivery of the medical implant device 1950, the outer sheath 2200 can be translated distal to the medical implant delivery catheter 1900 and the elongated housing 1800 to position the medical implant delivery catheter 1900 adjacent to the elongated housing 1800 before the medical implant delivery system 1700 is retracted. 【0106】 In one embodiment, the distal portion 1802 of the elongated housing 1800 may have a taper. The size of the distal portion 1802 can taper towards the distal end 1810. For example, the diameter of the elongated housing 1800 may taper towards the distal end 1810. In one embodiment, the distal portion 1802 of the elongated housing 1800 may have a pre-formed curve 1804. The pre-formed curve 1804 and / or taper in the distal portion 1802 may be configured to facilitate the positioning of the elongated housing 1800 to a blood vessel, passage, chamber, and / or organ in order to deliver the medical implant device and / or treatment to an accessible target site from within the blood vessel, passage, chamber, and / or organ. The radius of curvature and / or length of the pre-formed curve 1804 may be selected at least in part based on the shape and / or dimensions of the blood vessel, passage, chamber, and / or organ, such as the coronary sinus. In some embodiments, the length of the pre-formed curve 1804 may be predetermined based at least partially on the distance of the target tissue site from the coronary sinus hilum. In some embodiments, the radius of curvature of the pre-formed curve 1804 may be predetermined based at least partially on the shape of the coronary sinus, including the degree of curvature of the portion of the coronary sinus in which the elongated housing 1800 is positioned. The radius of curvature of the pre-formed curve 1804 may be selected so that the pre-formed curve 1804 can match or substantially match the curvature of the coronary sinus. For example, when positioned in the coronary sinus, the pre-formed curve 1804 may be positioned such that its medial edge 1806 is oriented toward a portion of the left atrial wall, and its lateral edge 1808 is oriented toward the opposite portion of the coronary sinus wall. In some embodiments, the elongated housing 1800 may include a shape memory material, including a distal portion 1802. The distal portion 1802 can adopt a gently curved configuration while being advanced towards the target tissue site. The pre-formed curve 1804 can adopt a curved configuration after positioning at the target site. The tapering at the distal portion 1802 facilitates insertion into the narrower portion of the coronary sinus.In one embodiment, the distal portion 1802 may include one or more radiopaque markers to facilitate visualization of positioning the elongated housing 1800 at a desired location within a blood vessel, passage, chamber, and / or organ, such as a coronary sinus. 【0107】 The elongated housing 1800 may include a recess 1814 configured to receive at least a portion of a medical implant delivery catheter 1900. The recess 1814 may extend along at least a portion of the length of the elongated housing 1800. For example, the recess 1814 may extend from a proximal portion, including the proximal end of the elongated housing 1800, to a distal portion 1802. In some embodiments, the distal end 1816 of the recess 1814 may be proximal to a pre-formed curve 1804. In some embodiments, the distal end 1816 of the recess 1814 may be on the pre-formed curve 1804. The recess 1814 may open along the same side as the inner edge 1806 of the pre-formed curve 1804. 【0108】 In one embodiment, the elongated housing 1800 may have an expandable mooring portion 1850 at its distal end 1802. The expandable mooring portion 1850 is shown in its retracted state in Figure 18. In one embodiment, the expandable mooring portion 1850 may be on the same side as the outer edge 1808 of a pre-formed curve 1804. In one embodiment, the expandable mooring portion 1850 may be on the pre-formed curve 1804. For example, the expandable mooring portion 1850 may be on the outer edge 1808 of a pre-formed curve 1804. In one embodiment, the expandable mooring portion 1850 may be on the portion of the elongated housing 1800 opposite the distal end 1816 of the recess 1814. In one embodiment, the expandable mooring portion 1850 may be on the proximal portion of the elongated housing 1800 opposite the pre-formed curve 1804. 【0109】 The expandable anchoring portion 1850 can be inserted into or near the target tissue site in a collapsed configuration. Subsequently, the expandable anchoring portion 1850 can be activated and / or actuated to take an expanded configuration to contact the tissue near the target tissue site in order to facilitate stable positioning of the elongated housing 1800 relative to the target tissue site. In some embodiments, expansion of the expandable anchoring portion 1850 can facilitate reliable positioning of the elongated housing 1800 by pressing it against a tissue portion opposite to the tissue portion of the target tissue site. In some embodiments, expansion of the expandable anchoring portion 1850 can press the elongated housing 1800 and / or the medical implant delivery catheter 1900 against the tissue adjacent to the target tissue site. Reliable positioning of the elongated housing 1800 at the target tissue site can facilitate the desired deployment of the puncture needle 2000 to form an opening. In some embodiments, the elongated housing 1800 may not have the expandable anchoring portion 1850. The puncture needle 2000 can be further extended, compared to the degree to which the puncture needle 2000 can be advanced when the expandable anchoring portion 1850 is used, so that the puncture component 2008 can contact and press against a target tissue site to facilitate efficient tissue puncture. For example, the puncture needle 2000 can be further extended to contact and press against the left atrial wall in order to perforate tissue in the left atrial wall. 【0110】 Referring again to Figure 18, the distal portion 1902 of the medical implant delivery catheter 1900 may have a tapered shape. The size of the distal portion 1902 may taper towards the distal end 1910, and the diameter of the medical implant delivery catheter 1900 will taper towards the distal end 1910. In one embodiment, the medical implant delivery catheter 1900 may have a pre-formed curve 1904 in the distal portion 1902. The pre-formed curve 1904 may have the same or similar orientation as the pre-formed curve 1804 of the elongated housing 1800. For example, when the medical implant delivery catheter 1900 is positioned in the coronary sinus, the inner edge 1906 of the pre-formed curve 1904 may be oriented toward the left atrial wall, and the outer edge 1908 of the pre-formed curve 1904 may be oriented toward the wall of the coronary sinus. In one embodiment, the pre-formed curve 1904 may have a smaller radius of curvature than the pre-formed curve 1804. 【0111】 In one embodiment, the tapering of the distal portion 1902 and / or the pre-formed curve 1904 can facilitate evaluation of the target tissue site while the medical implant delivery system 1700 is positioned in a blood vessel, passage, chamber, and / or organ. The tapering can facilitate effective puncture of the target tissue site and / or deployment of the medical implant device 1950 positioned in the medical implant delivery catheter 1900. The distal portion 1902 can be further extended through an opening formed in the target tissue site so that the medical implant device 1950 can be positioned and deployed within the opening. The tapering in the distal portion 1902 can facilitate insertion of the distal portion 1902 through the opening formed in the tissue. The pre-formed curve 1904 can cause the distal portion 1902 to follow a predetermined trajectory in order to facilitate extension of the distal portion 1902 through the opening. 【0112】 The medical implant delivery catheter 1900 may include a puncture needle lumen configured to slidably receive a puncture needle 2000. The puncture needle 2000 may extend through a puncture needle exit opening 1912 associated with the distal portion 1902 of the medical implant delivery catheter 1900, including a distal end 1910. In one embodiment, a pre-formed curve 1904 can facilitate proper positioning of the puncture needle 2000 at the target tissue site as the medical implant delivery catheter 1900 is advanced against the elongated housing 1800. Proper positioning of the puncture needle 2000 can enable effective puncture of the target tissue site. 【0113】 In one embodiment, the medical implant delivery system 1700 may include a puncture needle sheath 2100 configured to allow a puncture needle 2000 to pass through and extend. The puncture needle 2000 may extend through a puncture needle exit opening 2104 associated with the distal end 2106 of the puncture needle sheath 2100. The puncture needle sheath 2100 may extend slidably through the puncture needle lumen of a medical implant delivery catheter 1900. In one embodiment, at least a portion of the puncture needle sheath 2100 may pass through at least a portion of the puncture needle lumen of the medical implant delivery catheter 1900. In one embodiment, at least a portion of the puncture needle 2000 may pass through at least a portion of the lumen of the puncture needle sheath 2100. In one embodiment, the distal end 2102 of the puncture needle sheath 2100 may be associated with a radially expandable member 2150 configured to enlarge an opening formed in a target tissue site. The radially expandable member 2150 can be activated and / or operated after being positioned towards the opening in order to take an expandable configuration to enlarge the opening. In one embodiment, the radially expandable member 2150 may include an inflatable balloon positioned circumferentially around the distal portion 2102 of the puncture needle sheath 2100. 【0114】 In one embodiment, the distal portion 1902 of the medical implant delivery catheter 1900 may be configured to provide a desired expansion of the opening. For example, the distal portion 1902 may be inserted into the opening to enlarge it. The distal portion 1902 may have a size and / or shape to facilitate the expansion of the opening, such as having a predetermined diameter configured to provide a desired expansion. In one embodiment, the distal portion 1902 may be used to expand the opening instead of the radially expandable member 2150. For example, the puncture needle sheath 2100 and / or the radially expandable member 2150 may not be included. In one embodiment, the puncture needle 2000 may be positioned in the puncture needle lumen of the medical implant delivery catheter 1900 without the puncture needle sheath 2100. In one embodiment, the distal portion of the puncture needle 2000 may be configured to enlarge the opening. The distal portion may be inserted into the opening to enlarge it. For example, the distal portion may have a predetermined diameter to provide a desired expansion of the opening. In one embodiment, one or more of the puncture needle 2000, the distal portion 1902, and the radially expandable member 2150 can be used to expand an opening formed in the target tissue. 【0115】 In one embodiment, the puncture needle 2000 may be replaced with a medical implant guide wire. For example, the puncture needle 2000 may be used to perforate tissue, and after an opening is formed, the puncture needle 2000 may be retracted. The medical implant guide wire may be advanced through the puncture needle lumen instead of the puncture needle 2000. The medical implant device 1950 may be advanced along the medical implant guide wire to a target tissue site. For example, an expandable shunt device may be advanced along the medical implant guide wire to an opening formed in the left atrial wall. In one embodiment, the medical implant guide wire may be advanced through a puncture needle sheath 2100. In one embodiment, the medical implant delivery system 1700 may not have a puncture needle sheath 2100. For example, the puncture needle 2000 and / or the medical implant guide wire may extend through the puncture needle lumen of the medical implant delivery catheter 1900 without a puncture needle sheath 2100. 【0116】 The medical implant device 1950 may be positioned at the distal portion 1902 of the medical implant delivery catheter 1900. In some embodiments, the medical implant device 1950 may include a shunt device, including an expandable shunt device. As described in further detail herein, the distal portion 1902 may be further extended through an opening formed in the target tissue site so that the medical implant device 1950 may be positioned within and deployed. In some embodiments, the medical implant device 1950 may be positioned at a pre-formed curve 1904. The medical implant device 1950 may be circumferentially positioned around the distal portion 1902, including at the pre-formed curve 1904. 【0117】 An expandable shunt device may have several configurations. In one embodiment, the expandable shunt device may comprise an expandable tubular shunt device. An example of a suitable expandable shunt device for the medical implant delivery system 1700 is provided in U.S. Patent Application No. 15 / 335,891, entitled "Systems for Deploying an Expandable Cardiac Shunt," which is incorporated herein in its entirety. 【0118】 Figure 19 is a side view of the medical implant delivery system 1700, in which the puncture needle 2000 is further extended through the puncture needle exit opening 1912. A portion of the puncture needle 2000 is shown extending through the puncture needle exit opening 2104 associated with the distal end 2106 of the puncture needle sheath 2100. The puncture needle sheath 2100 is shown extending through the puncture needle exit opening 1912 associated with the distal end 1910 of the medical implant delivery catheter 1900. The expandable anchoring portion 1850 of the elongated housing 1800 is shown in an expanded state. 【0119】 The puncture needle 2000 may comprise an elongated portion 2002. The distal portion 2004 of the elongated portion 2002 extends through the puncture needle exit opening 1912 of the medical implant delivery catheter 1900. The puncture needle 2000 may comprise a puncture component 2008 associated with the distal end 2006 of the elongated portion 2002, the puncture component 2008 being configured for tissue perforation. The puncture needle 2000 may comprise a pre-formed curve 2010 in the distal portion 2004. The pre-formed curve 2010 may have the same or similar orientation as the pre-formed curve 1904 of the medical implant delivery catheter 1900. In some embodiments, the pre-formed curve 2010 may have a smaller radius of curvature than the pre-formed curve 1904. In some embodiments, the pre-formed curve 2010 may have the same or similar orientation as the pre-formed curve 1804 of the elongated housing 1800. In one embodiment, the pre-formed curve 2010 can facilitate effective tissue puncture at the target tissue site while the medical implant delivery system 1700 is positioned in a blood vessel, passage, chamber, and / or organ. 【0120】 In one embodiment, the distal portion 2004 of the puncture needle 2000 may include a shape memory material. The distal portion 2004 can remain in the medical implant delivery catheter 1900 before the medical implant delivery system 1700 is positioned at or near the target tissue site, and / or after the distal portion 2004 has been retracted to return to the medical implant delivery catheter 1900. In one embodiment, the pre-formed curve 2010 may take on a less curved configuration while retracted into the medical implant delivery catheter 1900 and / or the puncture needle sheath 2100. In one embodiment, the distal portion 2004 may take on a straight or substantially straight configuration while received into the medical implant delivery catheter 1900 and / or the puncture needle sheath 2100. The pre-formed curve 2010 in the distal portion 2004 can take on a curved configuration after extension of the distal portion 2004 through the puncture needle exit opening 1912 and / or through the puncture needle exit opening 2104 associated with the distal end 2106 of the puncture needle sheath 2100. 【0121】 Figure 20 is another side view of the medical implant delivery system 1700. The outer sheath 2200 is positioned to cover the medical implant device 1950. For example, the medical implant device 1950 is not shown in Figure 20 because the distal end 2202 of the outer sheath 2200 is distal to the medical implant device 1950 and thus extends over the medical implant device 1950. The distal end 1910 of the medical implant delivery catheter 1900 is shown as extending distally to the outer sheath 2200. The puncture needle 2000 and puncture needle sheath 2100, including the radially expandable member 2150, are shown extending from the puncture needle exit 1912 associated with the distal end 1910 of the medical implant delivery catheter 1900. The lancet 2000 is shown extending from a lancet exit opening 2104 associated with the distal end 2106 of the lancet sheath 2100. 【0122】 In one embodiment, while the medical implant delivery catheter 1900 is in a retracted configuration, the outer sheath 2200 may be positioned to cover the distal end 1910 of the medical implant delivery catheter 1900. The distal end 2202 of the outer sheath 2200 may be distal to the distal end 1910 of the medical implant delivery catheter 1900. In one embodiment, the distal portion 1902 may include a shape memory material. For example, a pre-formed curve 1904 can take a less curved configuration, including a linear configuration or a substantially linear configuration, while the outer sheath 2200 is positioned around the pre-formed curve 1904. The outer sheath 2200 positioned around the pre-formed curve 1904 can maintain the pre-formed curve 1904 in a linear configuration or a substantially linear configuration. In one embodiment, the outer sheath 2200, the elongated housing 1800, and / or the medical implant delivery catheter 1900 may be flexible so that they can conform to the shape of the anatomical path as the medical implant delivery system 1700 is advanced through a winding path. The outer sheath 2200 can hold the medical implant delivery catheter 1900 in a recess 1814 of the elongated housing 1800. The outer sheath 2200 may be configured to translate proximal to the implant delivery catheter 1900 in order to release the medical implant delivery catheter 1900. For example, the distal portion 1902 can be displaced from the recess 1814. A pre-formed curve 1904 may be made capable of taking on a curved configuration, such as after being released from the recess 1814. The medical implant delivery catheter 1900 may be able to translate distally to the outer sheath 2200 and / or the elongated housing 1800 in order to position the medical implant device into an opening formed in the tissue. 【0123】 The expandable anchoring portion 1850 is shown in the expanded state in Figure 20. The expandable anchoring portion 1850 may remain collapsed until the medical implant delivery system 1700 is positioned at or near the target tissue site. The expandable anchoring portion 1850 may remain collapsed while the medical implant delivery catheter 1900 is in the retracted configuration. In one embodiment, while the medical implant delivery catheter 1900 is in the retracted configuration, the outer sheath 2200 may cover and position the expandable anchoring portion 1850. The distal end 2202 of the outer sheath 2200 may be distal to the expandable anchoring portion 1850. In one embodiment, while the medical implant delivery catheter 1900 is in the retracted configuration, the outer sheath 2200 may remain proximal to the expandable anchoring portion 1850. 【0124】 In one embodiment, the puncture needle 2000 and / or the puncture needle sheath 2100 may be pre-assembled into the puncture needle lumen of the medical implant delivery catheter 1900. In one embodiment, the pre-assembled puncture needle 2000 and the pre-assembled puncture needle sheath 2100 may remain in the medical implant delivery catheter 1900 until the medical implant delivery system 1700 is positioned at or near the target tissue site. For example, the puncture component 2008 may not extend beyond the puncture needle exit opening 1912 until the medical implant delivery system 1700 is positioned in a blood vessel, passage, chamber, and / or organ. The puncture component 2008 may remain in the medical implant delivery catheter 1900 while the puncture needle 2000 is in a retracted configuration. In one embodiment, a portion of the puncture needle 2000 may extend through the puncture needle exit opening 1912 while the puncture needle 2000 is in a retracted configuration. In one embodiment, a puncture component 2008 extending beyond the puncture needle exit opening 1912 may be located proximal to the distal end 2202 of the outer sheath 2200 when the puncture needle 2000 is in a retracted configuration. For example, the puncture component 2008 may be received in a recess 1814 of the elongated housing 1800 until the medical implant delivery system 1700 is positioned into a blood vessel, passage, chamber, and / or organ. In one embodiment, the puncture needle 2000 and / or puncture needle sheath 2100 may be advanced from the proximal end of the medical implant delivery catheter 1900 to the puncture needle exit opening 1912 after the medical implant delivery system 1700 has been positioned into the desired blood vessel, passage, chamber, and / or organ. 【0125】 Figures 21–24 illustrate various steps of an example process for delivering a medical implant device, such as an expandable shunt device, from the coronary sinus to the left atrial wall using a medical implant delivery system 1700 as described herein. Referring to Figure 21, the medical implant delivery system 1700 can be advanced into the coronary sinus 18 along a guide wire 50. As described herein, the guide wire 50 can be inserted from the right atrium 5 through the coronary sinus hilum 17 into the coronary sinus 18. In some embodiments, a transcervical or transclavicular technique can be used to access the right atrium 5 via the superior vena cava. Alternatively, a transfemoral technique can be used to position the medical implant delivery system 1700 into the right atrium 5 via the inferior vena cava. The medical implant delivery system 1700 can then be positioned at a desired location within the coronary sinus 18. While the medical implant delivery system 1700 is advanced along the guide wire 50 to a desired location in the coronary sinus 18, the outer sheath 2200 may be positioned over the distal end 1910 (not shown) of the medical implant delivery catheter 1900 (not shown). The medical implant delivery catheter 1900 may be retained in a recess 1814 of the elongated housing 1800. The outer sheath 2200 may be proximal to the expandable anchoring portion 1850. In one embodiment, while the medical implant delivery system 1700 is positioned to a desired location, the outer sheath 2200 may be positioned over the expandable anchoring portion 1850. In one embodiment, the distal end 2202 of the outer sheath 2200 may be distal to the distal end 1816 of the recess 1814 or distal to it while the medical implant delivery system 1700 is advanced along the guide wire 50. 【0126】 In Figure 22, after the medical implant delivery system 1700 has been advanced to the desired location, the outer sheath 2200 may be translated proximally relative to the medical implant delivery catheter 1900 and the elongated housing 1800. The outer sheath 2200 may be slid proximally to release the distal portion 1902 of the medical implant delivery catheter 1900. The distal end 2202 of the outer sheath 2200 may be translated proximally so that at least a portion of the distal portion 1902 can be released from the recess 1814 of the elongated housing 1800. For example, a pre-formed curve 1904 may take on a curved configuration after the distal portion 1902 has been released. The medial edge 1906 of the pre-formed curve 1904 may be oriented toward the wall of the left atrium 2, and the lateral edge 1908 of the pre-formed curve 1904 may be oriented toward the wall of the coronary sinus 18. As described herein, in one embodiment, the puncture needle 2000 may be pre-assembled such that a puncture component 2008 extends through the puncture needle exit opening 1912 of the medical implant delivery catheter 1900. In one embodiment, the puncture component 2008 may extend beyond the puncture needle exit opening 2104 of the puncture needle sheath 2100. For example, the puncture component 2008 may extend beyond the puncture needle exit opening 2104 and the puncture needle exit opening 1912 while the medical implant delivery system 1700 is advanced to its target location, leaving the proximal end 2202 of the outer sheath 2200 unattended. Alternatively, the puncture component 2008 may extend through the puncture needle exit opening 1912 and / or the puncture needle exit opening 2104 after the medical implant delivery system 1700 has been positioned at or near the desired location. After the distal portion 1902 is released, the medical implant delivery catheter 1900 can be advanced distally so that the puncture component 2008 can contact the left atrial wall and be used to perforate tissue at a target tissue site in the left atrial wall. In one embodiment, the puncture needle sheath 2100 can be advanced relative to the medical implant delivery catheter 1900, etc., to facilitate contact between the puncture component 2008 and the left atrial wall.The puncture needle 2000 can be further advanced into the medical implant delivery catheter 1900 and / or puncture needle sheath 2100, etc., to form an opening in the left atrial wall. 【0127】 In one embodiment, a pre-formed curve 1904 of the medical implant delivery catheter 1900 can facilitate the positioning of the puncture needle 2000 at the target tissue site in the left atrial wall, and / or the subsequent insertion of the distal portion 1902 of the medical implant delivery catheter 1900 into an opening formed in the target tissue site. The pre-formed curve 1904 can provide a desired trajectory for the medical implant delivery catheter 1900 when it is advanced distally so that the puncture needle 2000 can contact the target tissue site in the left atrial wall in a lateral position relative to the medical implant delivery system 1700, and the distal portion 1902 of the implant delivery catheter 1900 can be inserted into an opening formed in the target tissue site. 【0128】 In one embodiment, the expandable anchoring portion 1850 can be activated and / or actuated to take an expanded state after the medical implant delivery system 1700 has been positioned in or near a desired location within the coronary sinus. In the expanded configuration, the expandable anchoring portion 1850 can come into contact with the wall of the coronary sinus 18 to facilitate the stable positioning of the medical implant delivery system 1700 at the desired location. Stable positioning of the medical implant delivery system 1700 can facilitate tissue puncture at the target tissue site and / or reliable deployment of the medical implant device 1950 into the opening. In one embodiment, expansion of the expandable anchoring portion 1850 can provide stable positioning of the elongated housing 1800 against the coronary sinus 18 to facilitate reliable puncture of the target tissue site in the left atrial wall. 【0129】 Referring to Figure 23, the puncture needle sheath 2100 may be extended toward an opening formed in the left atrial wall so that a radially expandable member 2150, associated with the distal portion 2102 of the puncture needle sheath 2100, can be positioned toward the opening to enlarge it. Enlarging the opening can facilitate the subsequent positioning of the medical implant device 1950 toward the opening. The radially expandable member 2150 may be activated and / or actuated after being positioned toward the opening to take an expanded configuration to enlarge the opening. As described herein, in one embodiment, the distal portion 1902 of the medical implant delivery catheter 1900 may be inserted toward the opening to provide the desired enlargement of the opening. 【0130】 The puncture needle 2000 can be advanced further through the puncture needle exit opening 2104 associated with the distal end 2106 of the puncture needle sheath 2100. The puncture needle 2000 can also be used as a guide wire along which the medical implant delivery catheter 1900 can be advanced so that the medical implant device 1950 (not shown) can be positioned at the opening in the tissue. Alternatively, the puncture needle 2000 can be replaced with a medical implant guide wire. For example, the puncture needle 2000 can be retracted after the opening has been formed in the left atrial wall. The medical implant guide wire can be advanced into the left atrium 2 through the puncture needle lumen of the medical implant delivery catheter 1900, and the implant delivery catheter 1900 can be advanced along the medical implant guide wire into the left atrium 2 to deploy the medical implant device 1950. Figure 23 shows that the outer sheath 2200 remains covering the medical implant device 1950 while the opening is formed in the left atrial wall. In one embodiment, the medical implant device 1950 may be distal to the lateral sheath 2200 while an opening is formed in the left atrial wall. 【0131】 Referring to Figure 24, the distal portion 1902 of the medical implant delivery catheter 1900 can be advanced through an opening formed in the left atrial wall so that the medical implant device 1950 can be positioned into the opening. The medical implant delivery catheter 1900 can be advanced along the puncture needle 2000 positioned in the left atrium 2 to position the medical implant device 1950 into the opening. An example of the process for deploying an expandable shunt device into the left atrial wall is provided in U.S. Patent Application No. 15 / 335,891, entitled "Systems for Deploying an Expandable Cardiac Shunt," which is incorporated herein in its entirety. 【0132】 The expandable shunt device, deployed into an opening formed in the left atrial wall, allows blood to flow from the left atrium 2 to the coronary sinus 18 and then to the right atrium 5, thereby reducing the elevated left atrial pressure. After the expandable shunt device is deployed into the left atrial wall, the puncture needle 2000 and the medical implant delivery catheter 1900 can be retracted. Subsequently, the medical implant delivery system 1700 can be retracted out of the coronary sinus along the guide wire 50. 【0133】 Figure 25 is a flowchart of an example of the process 2400 for deploying a medical implant delivery system to deliver a medical implant device. The medical implant delivery system may have one or more features as described herein, such as the features of the medical implant delivery system 1700 described with reference to Figures 18 to 24. 【0134】 In block 2402, process 2400 may include advancing a medical implant delivery system along a guide wire into a blood vessel, passage, venule, and / or organ. For example, a medical implant delivery system may be advanced along a guide wire into the coronary sinus. The medical implant delivery system may be used to access a target tissue site in a target blood vessel, passage, venule, and / or organ. For example, a medical implant delivery system may be used to access a target tissue site in a portion of the left atrial wall from within the coronary sinus. The medical implant delivery system may comprise an elongated housing, a medical implant delivery catheter extending alongside the elongated housing, and an outer sheath around the elongated housing and the medical implant delivery catheter. A medical implant device may be positioned on the medical implant delivery catheter for deployment to a target blood vessel, passage, venule, and / or organ. For example, a shunt device, including an expandable shunt device, may be carried on the medical implant delivery catheter for deployment to the left atrial wall. 【0135】 After the medical implant delivery system is positioned at the desired location within the coronary sinus, the puncture needle can be deployed to perforate the tissue at the target tissue site. The puncture needle may extend slidably through the puncture needle lumen of the medical implant delivery catheter. In block 2404, process 2400 may include translating the outer sheath distally to release the distal portion of the medical implant delivery catheter. As described herein, the distal portion of the medical implant delivery catheter may have a pre-formed curve. The distal portion may be provided with a shape memory material so that the outer sheath can assume a curved configuration after it has been slid proximal so that it is no longer present around the distal portion in order to position the distal portion alongside the elongated housing. 【0136】 In block 2406, process 2400 may include translating the medical implant delivery catheter distally to the elongated housing. The medical implant delivery catheter can be advanced distally so that the puncture needle can contact the target tissue. In one embodiment, the puncture component of the puncture needle may extend through a puncture needle exit opening associated with the distal end of the medical implant delivery catheter to facilitate contact between the puncture component and the target tissue. In block 2408, process 2400 may include perforating tissue to form an opening in the tissue at the target tissue site using the puncture component extending through the distal exit opening of the medical implant delivery catheter. 【0137】 In block 2410, process 2400 may include extending the distal portion of a medical implant delivery catheter through an opening formed in the tissue. The distal portion of the medical implant delivery catheter can be advanced through the opening so that a medical implant device supported for medical implant delivery can be positioned into the opening. In some embodiments, the distal portion may be configured to enlarge the opening in the tissue. For example, the distal portion may have a predetermined diameter to provide a desired enlargement of the opening. In some embodiments, the medical implant delivery system may include a puncture needle sheath configured to extend slidably through the puncture needle lumen of the medical implant delivery catheter, the puncture needle configured to slide slidably through the lumen of the puncture needle sheath. A radially expandable member may be associated with the distal portion of the puncture needle sheath. At least a portion of the radially expandable member may be positioned in the opening formed in the tissue and expanded to enlarge the opening. 【0138】 In block 2412, process 2400 may include deploying a medical implant device positioned in a medical implant delivery catheter into an opening formed in the tissue. For example, a shunt device may be deployed in the left atrial wall. 【0139】 Additional Embodiments Depending on the embodiment, any particular action, event, or function of any of the processes or algorithms described herein may be performed in a different order, added, merged, or even excluded. Therefore, in a particular embodiment, not all described actions and events are necessarily required for the execution of the process. 【0140】 In particular, conditional words used herein, such as “can,” “get,” “may,” “may,” and “for example,” are intended in their original sense unless otherwise explicitly stated or otherwise inferred in the context in which they are used, and are generally intended to convey that a particular embodiment includes a particular feature, element, and / or step, without other embodiments. Therefore, such conditional words are generally not intended to mean that the feature, element, and / or step are required in any form for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without input or motivation of the author, whether these features, elements, and / or steps are included in any particular embodiment or implemented in any particular embodiment. Terms such as “equip,” “include,” and “have” are synonyms and are used in their usual sense, comprehensively, and in an open-ended manner, without excluding additional elements, features, actions, etc. The term “or” is used in its comprehensive sense, for example, when used to connect a list of elements, to mean one, some, or all of the elements in the list. Conjunctions such as “at least one of X, Y, and Z” are generally understood to be used in contexts where, unless otherwise explicitly stated, they indicate that an item, term, element, etc., may be one of X, Y, or Z. Therefore, such conjunctions are generally not intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z, respectively. 【0141】 It should be understood that in the earlier descriptions of embodiments, various features have sometimes been combined in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various aspects of the invention. However, this method of disclosure is not to be construed as reflecting an intention that any claim requires more features than expressly proposed in that claim. Furthermore, any component, feature, or step illustrated and / or described in the specific embodiments herein may be applied to or used in conjunction with any other embodiment. Moreover, any component, feature, or step, or group of components, features, or steps, is not required or essential for each embodiment. Accordingly, it is intended that the scope of the invention disclosed herein and later claimed should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the subsequent claims. 【0142】 It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference, but do not necessarily imply physical characteristics or rank. Therefore, as used herein, ordinal terms used to modify elements such as structure, components, and actions (e.g., “first,” “second,” “third,” etc.) do not necessarily indicate the priority or order of an element relative to any other element, but rather generally distinguish an element from another element having a similar or identical name (due to the use of ordinal terms). Also, as used herein, the indefinite article ("a, an") may indicate “one or more” rather than “one.” Furthermore, actions performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly proposed. 【0143】 Unless otherwise specified, all terms used herein (including technical and scientific terms) have the same meaning as those generally understood by those skilled in the art in the art to which the example embodiments belong. Terms such as those defined in commonly used dictionaries should be interpreted as having the meaning consistent with their meaning in the context of the art in which they relate, and it should be further understood that, unless expressly defined herein, they should not be interpreted in an ideal or overly formal sense. 【0144】 Spatially relative terms such as “outside,” “inside,” “above,” “below,” “below ~,” “above ~,” “vertical,” “horizontal,” and similar terms may be used herein for ease of description to describe the relationship between one element or component and another, as shown in the drawings. It should be understood that spatially relative terms are intended to cover different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, if the device shown in the drawing is turned upside down, a device positioned “below” or “below” another device may be positioned “above” another device. Thus, the illustrated term “below ~” may include both the below and above positions. The device may be oriented in other directions, and therefore, spatially relative terms may be interpreted differently depending on the orientation. 【0145】 Unless otherwise explicitly stated, comparative and / or quantitative terms such as “less,” “more,” and “greater” are intended to cover equivalent concepts. For example, “less” can mean “less” in a strict, mechanical sense, but it can also mean “smaller or equal to.” [Explanation of symbols] 【0146】 1. Heart 2 left atrium 3 left ventricle 4 Right ventricle 5 Right atrium 6. Mitral valve 7. Aortic valve 8. Tricuspid valve 9. Pulmonary valve 10 septum 11 Pulmonary artery 12 Aorta 13 Right pulmonary artery 14 Left pulmonary artery 17 Coronary sinus portal 18. Coronary sinus 50 Guide wires 100 Medical Implant Delivery Systems 200 External delivery catheter 202 Distal part 204 Pre-formed curvature 206 Inner edge 210 Distal end 212 Guide wire exit opening 214 Side exit opening 220 guide wire lumens 250 Expandable mooring section 300 Medical implant delivery catheters 302 Distal part 304 Pre-formed curvature 306 Inner edge 310 Distal end 312 Puncture needle exit opening 350 Medical Implant Devices 400 puncture needle 402 Slender part 404 Distal part 406 Distal end 408 Puncture Component 410 Pre-formed curvature 500 Proximal handle 502 Advancement device 504 Rear bracket 506 Locking nut 508 Front Bracket 510 Flexible Arm 1000 Medical Implant Delivery System 1100 External delivery catheter 1102 Distal part 1104 Pre-formed curvature 1106 Inner edge 1108 Outer edge 1110 Distal end 1112 Guide wire exit opening 1114 Side exit opening 1114a Proximal part 1114b Distal part 1120 Guide Wire Lumens 1200 Medical implant delivery catheter 1202 Distal part 1204 Pre-formed curvature 1206 Inner edge 1208 Outer edge 1210 Distal end 1212 Puncture needle exit opening 1214 Distal end 1250 Medical Implant Devices 1700 Medical Implant Delivery System 1800 Slim Casing 1802 Distal part 1804 Pre-formed curvature 1806 Inner edge 1808 Outer edge 1810 Distal end 1812 Guide wire exit opening 1814 recess 1850 Expandable mooring section 1900 Medical implant delivery catheter 1902 Distal part 1904 Pre-formed curvature 1906 Inner edge 1908 Outer edge 1910 Distal end 1912 Puncture needle exit opening 1950 Medical implant device 2000 puncture needle 2002 Elongated section 2004 Distal part 2008 Puncture Components 2010 Pre-formed curvature 2100 Puncture needle sheath 2102 Distal part 2104 Puncture needle exit opening 2106 Distal end 2150 Radially expandable member 2200 Outer sheath 2202 Distal end C. The central longitudinal axis of the external delivery catheter 200.

Claims

[Claim 1] A puncture needle comprising an elongated portion and a puncture component at the distal end of the elongated portion, wherein the puncture component is configured to perforate the tissue in order to form an opening in the tissue, A medical implant delivery catheter comprising a puncture needle lumen, wherein the puncture needle is configured to extend slidably through the puncture needle lumen, and the puncture component is configured to extend through a puncture needle exit opening at the distal end of the medical implant delivery catheter, A medical implant device supported on the aforementioned medical implant delivery catheter, An elongated housing adjacent to the medical implant delivery catheter and slidable relative to the medical implant delivery catheter, wherein when the medical implant delivery catheter is in a retracted configuration, the distal end of the elongated housing is distal to the distal end of the medical implant delivery catheter; An outer sheath for a portion of the medical implant delivery catheter and around the elongated housing, for maintaining the medical implant delivery catheter adjacent to the elongated housing, wherein the outer sheath is slidable relative to the medical implant delivery catheter and extends to cover the distal end of the medical implant delivery catheter when the medical implant delivery catheter is in the retracted configuration. Equipped with, A medical implant delivery system comprising an elongated housing having a recess along at least a portion of the length of the elongated housing, wherein a portion of the medical implant delivery catheter is received in the recess. [Claim 2] The system according to claim 1, wherein the elongated housing comprises a guide wire lumen configured to receive an elongated housing guide wire, and the distal end of the elongated housing comprises a guide wire exit opening configured to allow the elongated housing guide wire to extend through the elongated housing. [Claim 3] The system according to claim 1 or 2, wherein the medical implant delivery catheter comprises a first tapered distal portion having a first pre-formed curve, and the elongated housing comprises a second tapered distal portion having a second pre-formed curve, and the first pre-formed curve and the second pre-formed curve have the same orientation. [Claim 4] The system according to claim 3, wherein the first pre-formed curve has a radius of curvature smaller than the radius of curvature of the second pre-formed curve. [Claim 5] The system according to claim 3, wherein the second pre-formed curvature is shaped to coincide with a curvature along the length of the coronary sinus. [Claim 6] The system according to any one of claims 1 to 5, wherein, opposite to a portion of the elongated housing adjacent to the medical implant delivery catheter, the system further comprises an expandable anchoring portion distal to the elongated housing, the expandable anchoring portion being configured to expand in order to position the medical implant delivery catheter against a target tissue site. [Claim 7] The system according to claim 6, wherein the elongated housing comprises a second tapered distal portion having a second pre-formed curve, and the expandable mooring portion is located on the outer edge of the second pre-formed curve. [Claim 8] A puncture needle sheath that extends slidably through the puncture needle lumen, wherein the puncture needle sheath extends slidably through the puncture needle, A radially expandable member in the distal portion of the puncture needle sheath, configured to enlarge the opening formed in the tissue, and The system according to any one of claims 1 to 7, further comprising the above. [Claim 9] The system according to claim 8, wherein the puncture needle is configured to be replaceable with a medical implant delivery guide wire.

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