Flow changing device with cover

Abstract

A flow altering device may include a plurality of struts coupled together to form a radially expandable frame having a proximal end and a distal end. The proximal end and the distal end may be radially expandable into expanded proximal and distal ends. A reduced diameter portion of the expandable frame may be disposed between the expanded proximal and distal ends, and the reduced diameter portion may include a fluid flow passage. A covering may be disposed on at least a portion of the radially expandable frame. The reduced diameter portion alters the flow of fluid through the flow altering device immediately after implantation of the flow altering device, and forms a pressure gradient between the inflow end and the reduced diameter portion.

Description

[0001] Priority claim

[0002] This patent application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62 / 795,836 filed on January 23, 2019 (Agent Docket No. 5130.020PRV) and U.S. Provisional Patent Application Serial No. 62 / 868,356 filed on June 28, 2019 (Agent Docket No. 5130.020PV2), each of which is hereby incorporated by reference in its entirety.

[0003] Cross-references to related patent documents

[0004] This application is related to U.S. Patent No. 9,364,354, the entire contents of which are incorporated herein by reference. Background Art

[0005] Blockage and / or stenosis of the coronary arteries may lead to chronic pain known as angina. Although not life-threatening, angina can lead to changes in quality of life. There are various treatments to address angina, such as medication, stenting, balloon angioplasty, and coronary artery bypass grafting (CABG). Angina, which is refractory to medication and interventional therapy, is a common and disabling medical condition and a major public health problem affecting millions of patients worldwide. Angina is common not only in patients who are not suitable for revascularization, but also in patients who have successfully undergone revascularization. After revascularization, the prevalence of angina is as high as 25% after 1 year and as high as 45% after 3 years. Various treatments for angina are currently available. Each treatment is promising, but may be limited to indications for certain uses, and therefore, new treatments are desired. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] In the accompanying drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The same reference numerals with different letter suffixes may represent different instances of similar components. The accompanying drawings generally illustrate various examples discussed in this document by way of example and not limitation.

[0007] Figure 1 is a schematic diagram showing a flow altering implant implanted in a coronary sinus vein.

[0008] Figure 2 is a schematic side view of a flow altering implant.

[0009] FIG. 3A to FIG. 3B An example of a flow altering implant is illustrated.

[0010] Figure 3Cyes Figure 3A Isometric view of a flow-altering implant mounted on a delivery catheter.

[0011] FIG. 4A to FIG. 4B Illustration of the planar layout of a slit-type flow-altering implant.

[0012] FIG. 4C to FIG. 4D Planar layout and isometric view of a slit-type flow-altering implant with smooth edges, respectively.

[0013] Figure 5 It is the vascular pathway leading to the coronary sinus.

[0014] Figure 6 is an isometric view of a dual-layer flow-altering implant.

[0015] FIG. 7A to FIG. 7G is an example of a flow altering implant.

[0016] FIG. 8A to FIG. 8B Isometric view and detail of the annular mesh flow-altering implant, respectively.

[0017] Fig. 9 is an isometric view of a mesh-type flow-altering implant with a partial covering.

[0018] Fig.10 An example of a flow altering implant is illustrated.

[0019] FIG. 11A1 to FIG. 11A3 An example of a flow altering implant is illustrated.

[0020] Figures 11B1 to 11B3 The delivery system and delivery sequence for the flow altering device are illustrated.

[0021] Fig. 11C An example of a flow altering implant is illustrated.

[0022] Fig.11D A flow altering implant is illustrated deployed in a blood vessel.

[0023] Fig.12 An example of a flow altering implant is illustrated.

[0024] FIG. 13A to FIG. 13B Diagram showing basic human heart anatomy.

[0025] FIG. 14A to FIG. 14C An example of a method of delivering a flow altering device to a treatment site is illustrated.

[0026] FIG. 15A to FIG. 15F Examples of flow altering implants having coverings on various portions of the implant are illustrated. DETAILED DESCRIPTION

[0027] In the accompanying drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The same reference numerals with different letter suffixes may represent different instances of similar components. The accompanying drawings generally illustrate various examples discussed in this document by way of example and not limitation.

[0028] Figure 1 1 is a schematic diagram showing a flow-altering implant 100 installed in a coronary sinus vein 102. The coronary sinus 102 drains a plurality of cardiac veins 106 into the right atrium 104. The cardiac cycle is typically hierarchical and includes stages of reduction (or increase) in vessel diameter. Thus, the vein 106 in turn drains a plurality of venules 108, which in turn drain a plurality of capillaries 110 after several stages. The capillaries 110 are supplied by a plurality of arterioles 112, which in turn are supplied by a plurality of coronary arteries 114 and 120 after several stages. A stenosis 116 is shown in the coronary artery 114. Although the cardiac cycle is typically hierarchical, there is some connection between the different branches. Sometimes, the presence of a stenosis 116 causes a collateral connection 118 to spontaneously form (or enlarge an existing connection) between the coronary arteries 114 and 120, bypassing the stenosis 116.

[0029] However, in some cases, this spontaneous formation does not occur. In any example, the flow altering implant 100 is placed in the coronary sinus 102 and has a significant stenosis sufficient to promote the formation of the collateral connection 118. Without being bound by any theory, it is speculated that the collateral connection 118 is caused by an increase in venous blood pressure, which in turn increases the pressure in the capillaries and / or causes retrograde flow in the capillaries and / or causes the capillaries to drain directly into the heart. However, even if this speculation is incorrect, several studies, including a large number of experiments and actual surgeries, have shown that constriction of the coronary sinus 102 generally leads to the formation of collateral circulation and / or otherwise improves the condition of patients with coronary artery obstruction. Alternative or additional speculations that may be optionally used to select the constriction effect of the flow altering implant 100 include:

[0030] (a) The flow-altering implant 100 increases pressure in the coronary capillaries upstream of the implant, thereby increasing perfusion duration.

[0031] (b) Increased resistance of the venous system leads to a redistribution of blood flow in the coronary arteries.

[0032] (c) Increased resistance of the venous system increases myocardial perfusion pressure and / or intramyocardial pressure.

[0033] (d) Increasing arterial diastolic pressure (by restricting venous drainage) causes arterial autoregulation to start working again, which is, for example, the kind described in Braunwald's textbook of cardiovascular medicine "Heart Disease", 5th edition, 1997, WB Saunders, Chapter 36, pages 1168-1169.

[0034] It should be noted that flow altering implant 100 may be selected to achieve one or more of the effects suggested above, optionally to a desired degree and / or considering safety issues, such as allowing some drainage and maximum pressure allowed by the coronary venous drainage system.

[0035] Figure 2 is a schematic side view of a flow altering implant 100 that can be used with any of the examples herein. The flow altering implant 100 includes a stenotic segment 204 and at least one flared segment 200 leading to the stenotic segment 204 (and optionally, the opposite end 202 is also flared). The segment 200 (and optionally the segment 202) includes segments 210 and 206 that are inclined relative to the wall of the coronary sinus 102 and segments 212 and 208 that are substantially parallel to the vessel wall.

[0036] In the examples and measurements shown or in any example herein, the flow-changing implant 100 can be radially expanded and can be slightly shortened during expansion: the implant can have a length of 20 mm before expansion and a length of about 18.8 mm after expansion. Alternatively, in any example, a non-shortening design can be used, such as a mesh in a peristaltic stent, such as a mesh in a peristaltic stent described in U.S. Patent No. 5,662,713, the disclosure of which is incorporated herein by reference. An example of a material thickness that can be used is 0.15 mm, however, thinner or thicker materials can be used. Other examples of implant lengths are 5 mm, 12 mm, 24 mm, 35 mm, 45 mm, and smaller, intermediate or larger sizes can be used. The length is optionally selected to match the physiological size (e.g., length and curve) of the target vein and / or to ensure good contact with the vein wall. The length of the narrow section 204 can be, for example, 0.5 mm, 1 mm, 2 mm, 3 mm, 5 mm, or any smaller, intermediate or larger length can be used to achieve desired flow dynamics. The example inner diameter of the flared section is between 2mm and 30mm, for example 5mm, 10mm, 15mm, 20mm, or any larger, smaller or intermediate diameter can be used in any example to match the vein or blood vessel diameter. The inner diameter of the stenotic section can be, for example, 1mm, 2mm, 3mm, 5mm, 10mm, or any smaller, larger or intermediate diameter can be used in any example to achieve the desired flow dynamics and / or the desired pressure difference across the flow-changing implant.

[0037] In any examples of flow altering implants, the ratio between the cross-section of the narrow section 204 of the flow altering implant 100 and the cross-section of the flared opening can be 0.9, 0.8, 0.6, 0.4, 0.2, or any larger, smaller, or intermediate ratio can be used to achieve the desired flow dynamics and / or desired pressure differential across the flow altering implant.

[0038] Although circular cross section is shown, any other cross section can be used, for example, polygonal, elliptical and ellipsoidal.The potential advantage of non-circular cross section is that implant is unlikely to be axially transferred and / or rotated.Alternatively or additionally, in any example, stream changes the outside of implant to be roughened and / or otherwise suitable for adhering to vein wall.Cross-sectional shape and / or orientation in any example can optionally change the length of implant 100 along stream.

[0039] Figure 3A The slit-type flow changes the planar layout of the implant's cutting pattern, and Figure 3B yes Figure 3AIn this planar arrangement, when flow altering implant 100 is expanded, it causes the ends of segments 200 and 202 to be parallel to the vessel wall.

[0040] In any example, the external flare of the flow altering implant 100 is formed by Figure 3B 340 and 342 shown in . Optionally, in any example, the total length of these sections defines the maximum flaring length. Alternatively or additionally, in any example, the bending area in these sections and the bending area between these sections define the relative force required to expand the flared area relative to the area near the edge. If the edge area is more difficult to expand and / or expands smaller than the adjacent area, the expansion of the flow-changing implant 100 will tend to bend the edge inward, or at least will not open outward. Alternatively, in the self-expanding flow-changing implant, the presence of sections 340 and 342 can be used to determine the final shape of the flare. Optionally in any example, an additional section 346 is provided around the circumference of the flow-changing implant 100, and the additional section 346 defines the external slit in the flow-changing implant 100, and the external slit can have the same maximum expansion as the nearby (axially inward) slit or smaller than the nearby (axially inward) slit. This design can also be used to control the shape of the flare.

[0041] The implant can be cut into a plurality of elongated axially oriented grooves substantially parallel to the longitudinal axis of the device by a hypodermic needle tube with a laser or by electrical discharge machining. Each groove is limited by a plurality of pillars, which are axially oriented pillars and are connected together with circumferentially oriented connector elements, thereby forming a series of rectangular grooves in a contracted configuration. The groove can be present on either side of the planar layout of the cutting pattern 100, and the middle portion 204 has a groove or no groove. The opposite ends of the device can have a smooth edge formed by the connector element in combination with the elongated pillar. The connector element can have an arcuate region forming an enlarged head region at the end. When a radial force such as from a balloon is applied to the inner diameter of the device, the device radially expands outward to form a flared expansion configuration.

[0042] In any example of a flow altering implant, the implant can be characterized by this maximum diameter, which can be used, for example, to select a specific flow altering implant to match a patient. Optionally in any example of an implant, during expansion, the balloon is aligned with the flow altering implant 100 so that the balloon contacts only the flared region of the flow altering implant 100 or only the non-flared region of the flow altering implant 100.

[0043] Figure 3C is a flow-altering implant 100 ( Figure 3A ) isometric view.

[0044] In any example of the implant, the flow altering implant 100 is formed by cutting from a sheet of metal or a tube, for example using a laser, water cutting, chemical etching, or metal stamping (e.g., thereby being welded to form a tube). Alternatively, the flow altering implant 100 is woven, for example, using methods known in the art (e.g., woven from metal or plastic fibers). Optionally in any example, the narrowing section 204 is made using a different method from the flared sections 200 and 202, for example, the flared sections are woven, while the narrowing section is cut from a sheet of metal. In any example, the flow altering implant may include a restraining ring that prevents the narrowing section 204 from expanding. Optionally in any example, the restraining ring may be able to plastically expand at a pressure higher than the pressure of the rest of the flow altering implant 100 that is capable of plastic deformation or self-expansion. Alternatively or additionally, in any example, the restraining ring is selected to set the desired degree of stenosis and is then mounted on the flow altering implant, stent, or stent graft for implantation. In a sleeve-type flow altering implant ( Figure 7G ), a similar effect can be achieved by suturing the stent graft.

[0045] When delivering the implant to the target treatment site, a standard balloon catheter with a single expansion zone, such as the Fox Catheter from Jomed, can be used. TM To promote the implant to reach its contour shape. When the balloon is pressed against the lumen of the implant, the stenotic segment is prevented from expanding, while the flared segments 200 and 202 expand under pressure. Various methods for preventing the stenotic segment from expanding are described below, for example, providing different mechanical properties, different designs or additional elements at the stenotic segment relative to the non-stenotic segment.

[0046] In any of the examples of implants, the flow altering implant 100 can be cut from a sheet and then twisted helically around a mandrel to form the shape of the flow altering implant 100. Alternatively, the flow altering implant 100 is cut from a tube, wherein the flared portion is a helical cut and the narrowed section is an annular cut. Alternatively, the flow altering implant 100 is formed as a helical spring having an axially varying relaxed position.

[0047] In any example of an implant, the flow altering implant 100 may be adapted for use in the coronary sinus or other coronary veins or other veins with non-muscular walls. Veins are characterized by low elasticity and relative sensitivity to tearing (compared to arteries). In any example, the edges of the flow altering implant 100 are bent or curled inwardly, such as Figure 1 130. Alternatively or additionally, in any example, in any example, the edge is folded back and / or smoothed to remove sharp edges. Alternatively, the parallel sections 208 and 212 ( Figure 2) is made long enough to support the flow altering implant 100 without damaging the coronary sinus 102. Alternatively or additionally, in any example, the flow altering implant 100 or at least the larger diameter portion thereof is made soft enough and / or has a low spring constant to prevent the flow altering implant 100 from exerting excessive pressure on the coronary flow altering implant wall. Alternatively or additionally, in any example, the flare of the flow altering implant 100 is coated with a bio-inert flexible coating, for example, a soft silicone elastomer or another soft plastic or rubber material, such as latex (Latex), Teflon (Teflon) and / or polyurethane (e.g., Angioflex, a bio-inert polyurethane plastic).

[0048] FIG. 4A to FIG. 4B The planar layout of the slit-type flow-changing implant 100 is shown in FIG. Figure 4B 4, edge 402 is defined by segments 440 and 446. As shown, these segments are designed to provide a relatively smooth edge that may have a small amount of deformation where the segments connect to segments 442 and 444 (so that edge 402 remains smooth). Segments 442, 444 and 446 together define an outer slit for edge 402. The structure of the implant, such as the struts, slots and connector elements, generally follows the same approach as previously described in the art. FIG. 3A to FIG. 3C Alternatively or additionally, in any example, there may be a connector 446 that may be in a "V" shape in the collapsed configuration. When expanded, the "V" shape may become defined as follows: Figure 4C Linear and circumferentially oriented struts with the edges best visible.

[0049] Patients who are candidates for angiogenesis-enhancing surgery may have significant vascular damage to the coronary circulation, with constriction and / or inadequate flow in one or more coronary arteries supplying blood to the coronary tissue. Invasive surgery, even with percutaneous introduction and / or positioning of a reduced implant 100 into the coronary sinus, may also result in cardiovascular events with adverse sequelae. Therefore, in some individuals it is desirable to avoid and / or limit the amount of time that the vasculature is invaded, for example, during the use of a balloon catheter.

[0050] FIG. 4C to FIG. 4D A plan view and an isometric view, respectively, of a slit-type flow altering implant 1100 with smooth edges.

[0051] In any example, the slit-type flow altering implant 1100 includes a shape memory material (e.g., Nitinol) that automatically achieves a final configuration state upon exiting, for example, a delivery catheter or sheath, thereby avoiding the use of a balloon catheter for initial deployment and implantation of the slit-type flow altering implant 1100. Alternatively, a balloon expandable material may be used, such as a material that plastically deforms upon expansion.

[0052] In any example, Figure 4C The slit-type flow-altering implant 1100 shown in plan view in FIG. 1 includes preformed slits 1102. The slits 1102 (and optionally a set of slits 1104 in a second or more rows) define rows 1122 (and rows 1124) along an outer edge 1132 of the slit-type flow-altering implant 1100, which includes at least one edge 1132 having a scalloped configuration in an unexpanded state. When expanded, for example Figure 4D , the edge 1132 becomes smooth and linear, while the slit 1102 takes on a rectangular appearance, for example, where the edge 1132 is transverse to the slit 1126. In any example of the invention, the slit of the edge is wider than the slit of the rest of the implant 1100, thereby affecting the final expanded configuration of the implant 1100.

[0053] In any example, the slit-type coronary flow altering implant 1100 is delivered to its deployed position in the coronary sinus using an introducer sheath without the concomitant balloon catheter. When the slit-type coronary flow altering implant 1100 reaches its destination and leaves its introducer sheath, the coronary flow altering implant 1100 automatically expands to its deployed position in the coronary sinus. Figure 4D The final shape is shown in FIG. In this manner, the slit-type coronary flow altering implant 1100 does not require manipulation and / or expansion using, for example, a balloon catheter.

[0054] Alternatively or additionally, in any example, for example, when the slit-type flow altering implant 1100 is made of a material that does not automatically achieve a memory shape, a balloon catheter can be used to facilitate expansion of the slit-type flow altering implant 1100. In any example, the rows of slits 1122 and / or 1124 have a length and / or orientation that facilitates the flow altering implant 1100 to form a final shape under the pressure of the balloon catheter, thereby facilitating installation with a minimal amount of time and / or stress on surrounding tissue.

[0055] In any example, the implant can have an hourglass-shaped body, wherein there are enlarged opposite ends and a contracted middle section. The enlarged end can include a flared section and an edge section. The flared section can be a monotonically increasing flared section and an edge section of constant diameter. The middle section can be roughly cylindrical. In the flared section, there are a plurality of elongated axially oriented grooves substantially parallel to the longitudinal axis of the device. Each groove is surrounded by a plurality of struts including a plurality of axially oriented struts, which are substantially parallel to the longitudinal axis and connected to one or more circumferentially oriented connector elements, thereby defining a rectangular groove. In the edge section, there are a plurality of elongated circumferentially oriented grooves substantially transverse to the longitudinal axis of the device. For example, the circumferentially oriented groove can be perpendicular to the longitudinal axis of the device. Each groove is surrounded by a plurality of struts including a plurality of circumferentially oriented struts, which are substantially transverse to the longitudinal axis and connected to one or more connector elements axially oriented and substantially parallel to the longitudinal axis of the device, thereby defining a rectangular groove. In the middle section, there are a plurality of elongated axially oriented grooves substantially parallel to the longitudinal axis of the device. Each slot is surrounded by a plurality of struts including a plurality of axially oriented struts that are substantially parallel to the longitudinal axis and connected together with one or more circumferentially oriented connector elements to define a rectangular slot. The struts in the middle region can be wider than the struts in the flared region, or the struts in the edge region, or the struts in both, to create a more rigid region that does not radially expand as much as the flared region. Similarly, the length of the struts can be longer or shorter, or adjusted to the struts in the flared region to control radial expansion. Alternatively or additionally, in the flared region, the slots can be multiple sizes with varying lengths and widths, and thus the slots can be the same or different.

[0056] In any example, the slit type coronary flow changes implant 1100 and is designed to change its shape in response to manipulation and / or expansion after installation. In any example, the slit 1138 expands to make the narrow passage 1168 automatically reach the first diameter during installation. In any example, after the slit type coronary flow changes implant 1100, the balloon catheter is introduced into the narrow passage 1168 and expands to radially outwardly squeeze on the narrow passage 1168. In any example, according to the stiffness of the component material, the pressure between 7 atmospheres and 8 atmospheres, or less than 7 atmospheres or greater than 8 atmospheres, expands the expansion slit 1138 to a larger cross section. This makes the narrow section 1168 have a larger diameter than the diameter it has just after installation.

[0057] Although not shown, some of the slits, such as slit 1138, can be tilted relative to the longitudinal axis of the implant, and therefore may require different degrees of force to expand and / or provide twisting of the deployed implant. Providing a relatively tilted slit can be used in any example to control the shortening of the implant. The tilted slit can be used to bias the implant to shorten when expanded.

[0058] In any example, when the flow-altering implant 1100 is installed, little or no blood moves through the walls of the narrow channel 1168 and / or the walls of the flared opening 1160 to contact the walls of the coronary sinus. This can be achieved by the narrow configuration of the slit. Alternatively or additionally, the length of the slit decreases near the narrow portion 1168.

[0059] In any example discussed herein, stenosis 1168 remains unexpanded or only partially expanded, and one or more flares 1160 on either end can be expanded to engage with the vessel wall to anchor the device. The diameter of a typical coronary sinus can be 4mm to 16mm, so the diameter of the flared end of the implant can be expanded to about 4mm to 16mm, but this is not intended to be restrictive. The flared end can be expanded to any size to engage and anchor the implant in the treatment area tissue. Similarly, stenosis 1168 can have a diameter of about 2mm to 4mm in diameter to provide desired flow characteristics, but this is not intended to be restrictive. Therefore, when expanded, stenosis 1168 can have a diameter of 10% to 50% of the flared diameter, or 15% to 45%, or 20% to 40%, or 25% to 35%, but this is not intended to be restrictive.

[0060] In any example, to achieve restriction and / or cessation of blood flow through the implant wall, the number of slits (e.g., not just the slits 1102 and 1104 at the edges) is increased, while the width of the slits is changed. The viscosity of the blood impedes its flow through the slits of reduced width, and the increase in the number of slits can promote expansion of the implant 100. This may result in a net reduction in blood flow through the implant wall.

[0061] Alternatively or additionally, in any example, the slit width can be used to help define the device geometry. For example, the slit (actually the space) 1104 is wider than the other slits. If the slit 1104 is made wider than the slit 1102, it may cause the edge to bend.

[0062] Also shown is optional design, wherein, slit is arranged in the alternating row of long slit and short slit.Alternatively or additionally, in any example and as shown, the size and / or density of the slit near the edge of implant 1100 is larger than the size and / or density of the slit near the center of implant 1100.Alternatively and additionally, in any example and as shown, the length of slit increases as a function of the distance from stenoses 1168.

[0063] like Figure 4D As shown in , the material of implant 1168 is distorted due to expansion. Alternatively or additionally, in any example, the slit is distorted and the material is distorted to conform to these distortions. For example, the short axial slit closest to the edge realizes a trapezoidal shape instead of a rectangular shape. In general, the expansion configuration is idealized, wherein the actual expansion shape may include a stepped distortion caused by the discrete pattern of the slits in the implant.

[0064] Figure 5 A vascular path to the coronary sinus 102 is shown, which can be used with any example of a flow altering implant. The flow altering implant 100 can be implanted using a transvascular approach, for example, from the venous system or by implanting through the inner wall of a cavity in the heart. In any example of the method, a delivery system is inserted into the right atrium 506 of the heart 500 through the jugular vein 510 or the subclavian vein 512 via the superior vena cava 508 and / or the femoral vein 502, via the inferior vena cava 504. Once in the right atrium 506, the delivery system is guided (e.g., through a sharp bend) to an opening 514 into the coronary sinus 102. In some patients, a valve is present at the entrance of the coronary sinus 102.

[0065] Figure 6 is an isometric view of a dual layer flow altering implant 1400. In this example, the dual layer flow altering implant 1400 includes a first flared section 1450 and / or a second flared section 1460. For purposes of clarity, only the components of flared 1460 will be focused on, however similar features may apply to flared section 1450.

[0066] In any example, the double layer flow altering implant 1400 includes a flared section 1460, which includes an outer cone 1420 and an inner cone 1410. For example, the double layer flow altering implant can be formed by placing any of the flow altering implants disclosed herein inside a second flow altering implant that can be any example disclosed herein. For example, the inner cone 1420 includes slits 1422 and 1426 and the outer cone 1410 includes slits 1412 and 1416, so that the cones 1410 and 1420 can be delivered to the implantation site in a non-expanded state and expanded at the implantation site. The flared portion of any example disclosed herein can be linear and monotonically increasing, with or without a flat linear plateau section, or the flared portion can be a curved flare with a linear plateau section. The struts, slots, and cross-sections are generally of the same Figure 4D The same form as in the form.

[0067] Further expansion of cones 1410 and / or 1420 may be desirable and may be incorporated into their respective designs such that cones 1410 and / or 1420 expand to a first diameter when squeezed radially outward by a balloon catheter at a first expansion pressure. Then, cones 1410 and / or 1420 may expand to a second, larger diameter when squeezed radially outward by a balloon catheter at a second, larger expansion pressure.

[0068] In any example, when slits 1422 and 1426 are circumferentially aligned with slits 1412 and 1416, respectively, blood flows in direction 1454 (e.g., in Figure 1 1432 and 1436. With the slits 1412 and 1422 and / or the slits 1416 and 1426 aligned, the flow altering implant 1400 can be implanted in a vessel having a relatively slow flow velocity and / or a relatively low pressure. For example, in the case of implantation in the coronary sinus, the stenotic region 1440 may be filled with tissue (e.g., endothelialized), which helps to anchor the implant 1400 without the risk of embolism.

[0069] Alternatively or additionally, due to flow restriction or cessation into space 132 (at Figure 1 ), a blood clot may form and stabilize in place in region 1440. The stabilized blood clot in region 1440 becomes incorporated into the surrounding tissue and against the bi-conical flow altering implant 1400, further stabilizing the blood clot in place.

[0070] In any example, slits 1422 and 1426 can be rotated relative to slits 1412 and 1416 prior to implantation so that blood flow in direction 1451 is substantially blocked to varying degrees. With slits 1422 and 1426 misaligned, reduced implant 1400 can be implanted in a vessel having a relatively high flow velocity and / or a relatively high pressure, such as the main trunk of an artery, thereby protecting the patient from the risk of embolic transfer.

[0071] In any example of the examples described in this article, the flow-changing implant has a flared end, and the flared end has a cross-sectional area larger than the cross-sectional area of ​​the middle part. Due to the continuity of the flow, the flow rate must be the same in the entire range of the flow-changing implant discussed in this article. Therefore, due to the smaller cross-sectional area of ​​the middle part, there is a higher fluid velocity and a lower pressure in the middle part, resulting in a lower velocity and a higher pressure in the inflow area and the outflow area of ​​the flared end.

[0072] The alignment of the slits 1422 and 1426 is optionally set relative to the slits 1412 and 1416 before implantation in the blood vessel to establish a predefined blood flow pattern, and the two layers expand or are allowed to expand together. In order to ensure that the cones 1410 and 1420 remain fixed in place relative to each other, the cones 1410 and / or 1420 have, for example, can include friction surface joints and / or interdigitated portions in any example. Alternatively or additionally, in any example, the two layers can be deployed in different ways, for example, the inner layer can be plastically deployed, while the outer layer is self-deployed. Possibly, the profiles of the two layers do not match along their entire length. Alternatively or additionally, in any example, the outer layer is plastically deformed by the self-deployment of the inner layer (which can also provide friction for locking). Alternatively or additionally, in any example, the cone 1420 can be rotated after implantation, for example using an appropriate internal engagement catheter.

[0073] The flared sections 1450 and 1460 may be symmetrical or the flared sections 1450 and 1460 need not be symmetrical. For example, the implant may also choose between flow obstruction at one section, flow obstruction at another section, and optionally flow obstruction at both sections. Flow only into the space 132 may assist in clot formation. Flow only out of the space 132 may assist in constricting surrounding blood vessels.

[0074] FIG. 7A to FIG. 7G Various flow altering implant variations are illustrated. Although an S-shaped flare is shown, linear or other flared designs may also be provided.

[0075] Fig. 7AIt is a flow-changing implant 900 having a narrow section 902 and a single flared section 904. The narrow section 902 can point upstream or downstream. A potential advantage of this design is that the delivery system is unlikely to get stuck inside the narrow section 902. Another potential advantage is that a completely blocked implant can be provided. However, in any example, even such a completely blocked implant has smooth sides to prevent damage to the coronary sinus. Possibly, the outer diameter of the completely blocked implant or the outer diameter of the almost completely flow-changing implant is increased to exceed the outer diameter of the coronary sinus to prevent displacement of the implant. Alternatively or additionally, in any example, one or more barbs (not shown) can be provided on the outside of the implant. Optionally, the cone-shaped flow-changing implant is provided with one or more openings for blood flow on the face of the cone, rather than at the apex of the cone as shown in the figure. For example, one or more orifices can be provided on the side wall of the device.

[0076] As an alternative to a conventional flow-altering implant, the stenosis may be a valve, for example, a valve that opens to full or partial diameter after appropriate pressure is achieved in the coronary sinus distal to the right atrium. For example, a leaflet valve or other type of vascular valve known in the heart may be provided.

[0077] Figure 7B An alternative flow altering implant 910 is shown with two narrow sections 912 and 916 and a flared section 914 sandwiched between the narrow sections 912 and 916. Optionally, the different narrow sections have different inner diameters, so one may be larger than the other. Optionally, a balloon is used to selectively expand the narrow sections to achieve a desired pressure distribution.

[0078] Figure 7C is an alternative flow altering implant 920 having three narrow sections 922, 926, and 929 and two flared sections 924 and 928 between the narrow sections.

[0079] Some blood vessels may taper along their length, forming Fig.7D 1310 is shown in FIG. 1310. For example, in the coronary sinus, there may be a vessel that changes size along its length as the coronary sinus drains into the right atrium. In a tapered vessel, it may be desirable to utilize an implant according to an example of Fig.7D The tapered flow altering implant 930 ( Fig. 7E ).

[0080] Fig.7D1 is an isometric view of an example of a tapered flow altering implant 1300 having a similar configuration to implant 930. The tapered flow altering implant includes a smaller flared section 1330, a narrow section 1340, and a larger flared section 1320. The size of the smaller flared section 1330 is controlled, for example, by one or more slits 1342 transverse to the axis of the narrow section 1340 and one or more slits 1346 substantially parallel to the longitudinal axis.

[0081] The size of the larger section 1320 is controlled, for example, by two or more slits 1322 transverse to the axis of the narrow section 1340 and two or more slits 1320 substantially parallel to the longitudinal axis.

[0082] Optionally, the slits 1342, 1346, 1322, and / or 1326 can vary in size and / or geometry to control the shape of the flared sections 1320 and / or 1330. Alternatively or additionally, in any example, the slits 1342, 1346, 1322, and / or 1326 can have various arrangements to provide different profiles to the flared sections 1320 and / or 1330 and / or the narrow section 1340.

[0083] Although openings 1330 and 1320 are shown as being round, they can have various configurations to conform to the different vessel configurations described above. In addition, the ratio between openings 1330 and 1320 can be varied to conform to any vessel diameter for implanting flow-altering implant 1300. As in other figures, the material of the implant is shown as being twisted, and in some examples, the twist may be a slit in addition to the material.

[0084] Fig. 7E is a tapered flow altering implant 930 in which one flared section 932 has a smaller diameter than a second flared section 936 but larger than a middle narrow section 936 .

[0085] exist Figure 7F In the example, the flow-altering implant 940 is not axially and / or rotationally symmetrical about its axis. In any example, the first flared section 946 is twisted relative to the axis defined by the second flared section 942 and the narrow section 944.

[0086] Optionally, flow altering implant 940 is curved. Here, the asymmetric or curved flow altering implant includes special markings, for example, including radiopaque or radiolucent areas, to assist in the correct orientation of flow altering implant 940 in the blood vessel.

[0087] Figure 7GIt is a flow-changing implant 950, wherein the narrow section 954 is a sleeve 954. The sleeve 954 is formed, for example, of a flexible graft material. Such as DACRON or GORTEX. The flow-changing implant 950 also includes at least one of two outer rings 952 and 956 for anchoring the flow-changing implant 950 in the blood vessel. The potential advantage of using a sleeve is that it can be bent to conform to the vein geometry and / or dynamics. Other flow-changing implant designs can also be bent. Optionally, the graft material is elastic, so it can be used as a pressure-limiting valve to better control the coronary sinus pressure. Optionally, a constraint ring is set on the outside of the section 954 to limit the lumen of the flow-changing implant 950. Optionally, during surgery, the ring is placed on the flow-changing implant 950 to achieve the desired narrowing effect. Alternatively or additionally, in any example, the ring can be expanded, for example, using a balloon, to allow control of the narrow section of the flow-changing implant 950. Optionally, the ring is sutured to the narrow section 954. Optionally, segment 954 is reinforced, for example using wires, as known in the art of stent graft technology. The flow altering implant can be any of the implants disclosed herein having a covering disposed thereon. In any example, the covering can be porous, semi-porous, or non-porous.

[0088] In any example, the flow altering implant 100 is provided in kit form, possibly with a delivery system, a flow altering implant diameter control system, additional flow altering implants, external bands, and / or other devices for reducing its inner diameter and including instructions for use and / or size markings. Optionally, the flow altering implant 940 is provided to be inserted into a delivery system or packaged with a delivery system.

[0089] As described above, in any example, the flow altering implant can be constrained by providing a band on the exterior of the implant.

[0090] FIG. 8A to FIG. 8B 1 and 2 are isometric views and details of an example of an annular mesh flow-modifying implant. In any example, the mesh flow-modifying implant 1500 ( Fig. 8A ) includes a flared shoulder 1502 and / or a flared shoulder 1504 of relatively long length, for example to increase the contact area between the flow-altering implant 1500 and the surrounding vessel wall. Alternatively or additionally, in any example, tissue can grow through the mesh of the flared shoulders 1502 and / or 1504, thereby providing good anchoring of the mesh-type flow-altering implant 1500. Optionally, the mesh-type flow-altering implant 1500 includes and / or is coated with a material that promotes tissue ingrowth. Also optionally, an edge 1620 is provided on each shoulder, which edge 1620 can be, for example, serrated (e.g., a scalloped edge) or smooth.

[0091] Optionally, the initial shape of the reticular flow altering implant 1500 is controlled by one or more bands 1522 and / or 1524 that constrain a region 1528 of the reticular flow altering implant 1500. In any example, the surrounding tissue collapses onto the reticular flow altering implant 1500 to alter blood flow through the wall of the constricted region 1528. Although two bands 1522 and 1524 are shown, a single band, such as only band 1522, may be used to create the constricted region 1528.

[0092] In any example, for example, the operator manually ties the ends of the ribbon together before implantation to adjust the loop formed by the ribbon 1522 and / or 1524 on the circumference. Adjusting the ribbon 1522 and / or 1524 before implantation allows the operator to establish a constriction area 1528 of a specific size to change blood flow, and thereby promote angiogenesis or otherwise redirect blood flow. Alternatively or additionally, in any example, for example, a balloon catheter is expanded in area 1562 to cause expansion of the ribbon 1522 and / or 1524, thereby expanding area 1562 to increase blood flow through area 1562. In this way, changes in blood passing through the flow-altering implant 1500 can be adjusted before and / or after the flow-altering implant 1500 is placed in a blood vessel.

[0093] In any example, the ribbon 1524 may be fragile and tear when a large expansion force is applied against it. To adjust the diameter of the region 1528 after implantation, the balloon catheter is positioned inside the region 1562 and expanded until the pressure exceeds the pressure required to tear the ribbon 1524. In the event that the ribbon 1524 is torn, the area of ​​the mesh region 1562 directly below the ribbon 1524 expands so that the diameter of the region 1562 expands so that the region 1562 has the diameter of the ring 1522.

[0094] Optionally, in any example, the ribbon 1524 has a smaller diameter than the ribbon 1522, thereby providing two-stage expansion. For example, when the balloon catheter is expanded to a first diameter, the balloon catheter expands the smaller diameter ribbon 1524, thereby increasing the diameter of the contraction region 1528 to the first expanded diameter. If a further increase in flow is required, the balloon catheter is expanded to a second diameter and the larger diameter ribbon 1524 and / or the smaller diameter ribbon 1524 are expanded, thereby increasing the diameter of the contraction region 1528 to the second expanded diameter.

[0095] Ring 1524 has, for example, a diameter of 6 millimeters, while ring 1522 has a diameter of 8 millimeters, such that region 1562 has a flow channel of 6 millimeters. By inflating the expansion balloon inside region 1562 and causing ring 1524 to tear, the region below ring 1524 will expand. However, ring 1522, which has a diameter of 8 millimeters, maintains its integrity. Thus, region 1562 now has a flow channel of 8 millimeters (minus the thickness of the mesh or other material forming the implant).

[0096] Figure 8B 1 is a detail of an example of a ring 1522 that includes an adjustable band 1540 that forms the ring 1522 and is held at a specific diameter by a buckle 1544. Alternatively or additionally, in any example, the adjustable band 1540 is held at a specific diameter by a buckle 1546. In any example, buckles 1544 and / or 1546 hold the adjustable band 1540 so that the ring 1522 is held at a specific diameter during implantation until, for example, a dilation balloon catheter resists expansion of the adjustable band 1540 and the diameter of the ring 1522 expands. In any example, buckles 1544 and 1546 include, for example, a nylon material that holds the band 1522 at a specific diameter and allows expansion of the diameter only under dilation pressure from, for example, a balloon catheter. Optionally, two buckles are provided so that no portion of the band 1540 protrudes from the ring. In any example of the invention, the buckle is "C" shaped and the strap 1540 optionally includes a protrusion that prevents the strap from sliding through the buckle. Alternatively or additionally, in any example, friction prevents such sliding.

[0097] In any example, for example, the flared shoulders 1504 and / or 1502 have a length of 0.5 cm to 1 cm, however their lengths may be less than 0.5 cm or greater than 1 cm, depending on the vessel configuration.

[0098] In any example, mesh flow altering implant 1500 includes strands including GORTEX, DACRON and / or steel forming its mesh. In addition, the material constituting the mesh can be configured to be flexible or rigid, depending on, for example, the material, the thickness of the material, based on, for example, desired flow dynamics.

[0099] Fig. 91 is an isometric view of a mesh flow altering implant 1600 with a partial cover. The mesh flow altering implant 1600 includes a cover 1614 above or within a stenotic segment 1624, which is implanted in a blood vessel 1680, shown in cross section. In any example, the mesh flow altering implant 1600 includes one or more flared shoulders 1602 that contact the blood vessel 1680 to provide anchoring. An edge 1620 is also optionally provided on each shoulder, which edge 1620 can be, for example, serrated or smooth.

[0100] Alternatively or additionally, in any example, the mesh flow altering implant 1600 includes a covering 1614 that limits blood flow through the wall surface of the flow altering implant 1600 and / or blood turbulence in the constriction region 1624, thereby reducing the risk of embolic transfer issues.

[0101] In any example, the covering 1614 includes a separate flexible layer that is attached to the flow-altering implant 1600 at several points (e.g., at the contraction area 1624 and / or the flared shoulder 1602) to prevent tearing when the implant 1600 expands. For example, before expansion, the covering 1614 is folded and / or pleated. Alternatively or additionally, in any example, the covering 1614 has a low volume and is, for example, integrally incorporated into the flow-altering implant 1600 structure, such that the covering 1614 substantially spans the open area of ​​the mesh. Examples of materials constituting the covering 1614 include GORTEX, latex, and / or silicone on the interior and / or exterior of the flow-altering implant 1600. Additional details about various configurations of coverings that can be applied to any example of the flow-altering implant disclosed herein will be disclosed later in this application.

[0102] Fig.10A flow altering device 2000 known in the art is illustrated. The flow altering device 2000 is an implantable device capable of radial expansion. In some examples, the device is formed by a plurality of connecting struts 2040 and 2030. The struts are generally axially oriented and parallel to the longitudinal axis of the device. When the device is in its radially contracted configuration, it has a low profile and can be delivered to a target treatment site by a catheter. The interconnected struts generally form a plurality of rectangular shaped cells 2040, wherein rectangular windows pass through the rectangular shaped cells 2040. When the device is radially expanded, the rectangular cells radially expand into diamond shaped cells 2030 at the proximal end 2010 and the distal end 2020 of the device. In the middle section 2050 between the proximal end 2010 and the distal end 2020, the rectangular cells 2040 can remain substantially rectangular or they can form small diamond shaped cells, depending on how large the middle section is expanded. The expanded diameter of the middle section 2050 can be any diameter, but the diameter can be between 2 mm and 4 mm. Additionally, in any example, the cells in the proximal end 2010 and the distal end 2020 have a length and a height. The height generally decreases from the proximal end 2010 and the distal end 2020 inwardly toward the middle section 2050. Additionally, due to the shortening of the cells during radial expansion, the length of the cells can decrease from the proximal end 2010 and the distal end 2020 inwardly toward the middle section 2050. Thus, the proximal end 2010 and the distal end 2020 generally flare to form a flared end, and the diameter of the proximal end 2010 and the distal end 2020 can increase monotonically from the middle section 2050 outwardly toward the proximal or distal end section. The middle section 2050 has a significantly changed diameter relative to the expanded proximal flared end and the distal flared end. Additionally, over the entire length of the device, assuming retrograde placement in the coronary sinus via the right atrium, the proximal end 2010 or downstream end can have a larger diameter than the diameter of the distal end 2020 or upstream end. In another example, the proximal end 2010 or downstream end may have a smaller diameter than the distal end 2020 or upstream end, possibly in the case of delivery in the antegrade direction. The larger diameter proximal end tapers to a varying diameter toward a central region where the diameter may be smallest, and then increases in diameter toward the smaller diameter distal end. Or, described another way, the diameter tapers from either end of the device toward the middle section. The diameter of the proximal end 2010 or the distal end 2020 may be a predetermined size or made to expand to a variable size.

[0103] The flow changing device can be balloon expandable or it can be self-expanding. Once deployed in the body cavity, the flared end of the larger diameter engages adjacent tissues and anchors the device to the vessel wall. The size of the frame can be expanded to be 10% to 20% larger than the vessel diameter, or 10% to 15%, or 15% to 20% to help ensure correct engagement and embedding in adjacent tissues. Fluid flows into the device, and due to the intermediate region of the smaller diameter, the cross-sectional area is reduced, and the flow rate is accelerated, thereby generating a pressure gradient across the device. In addition, over time, the device will become endothelialized and the tissue will grow inwardly into or on the metal struts of the device, thereby further helping to anchor the device and change the flow through the device and establish the pressure gradient on the device. In fact, high back pressure may force blood flow into other blood vessels that supply the myocardium that needs more blood supply, thereby helping to relieve ischemia and angina. Additionally, the pressure gradient generates back pressure, which can also help new blood vessels to form due to side branch opening, side branch formation, angiogenesis and angiogenesis. In any example, the proximal end 2010 of the device, which is closer to the right atrium, has a larger diameter than the distal end of the device to accommodate the natural tapering of the lumen, such as in a vessel such as the coronary sinus. However, one of ordinary skill in the art will appreciate that the proximal end 2010 can have the same diameter as the distal end 2020, or the distal end 2020 can have a larger diameter than the proximal end 2010. Further details regarding the pressure and flow altering device are disclosed in U.S. Patent No. 9,364,354, the entire contents of which are incorporated herein by reference. Fig.10 Any aspect of the expandable frame in can be applied to any example of the flow altering implant described herein.

[0104] Fig.11A1 , Fig.11A2 and Fig.11A3 Several examples of flow-modifying devices with covers are shown. The covers allow for instant flow modification upon implantation, unlike Fig.10 In the uncovered example, tissue ingrowth takes time and therefore a complete change in flow is not seen in the weeks before tissue ingrowth. Fig.11A1 A flow altering device having a full cover is included. The radially expandable frame may be Fig.109,364,354, incorporated by reference, or any other frame disclosed herein or known in the art. In this example, the covering 2060 can be any material such as a fabric, a composite such as PTFE, ePTFE, DACRON, or any other polymer, or the covering 2060 can be any tissue such as pericardial tissue or other biological tissue. The covering 2060 can be attached to the frame using sutures, adhesives, or any other technique known in the art. The covering 2060 can be disposed on the outer surface of the frame, on the inner surface, only in the open cell area, or any combination thereof. The device with a complete covering immediately changes the flow after implantation and can immediately relieve angina.

[0105] Fig.11A2 The middle example seen in illustrates a flow altering device with a partial cover. In this example, the middle section 2095 of the flow altering device remains uncovered, while the flared ends have a proximal cover 2065 and a distal cover 2070. As shown, the ends of the frame in the flared area can be completely covered, or these ends remain partially uncovered. The end of the proximal flared end can be an uncovered portion 2090, or the end of the distal flared end can be an uncovered portion 2080. This may have clinical advantages because the pressure gradient across the device will appear immediately after implantation, and therefore the anti-anginal effect and anti-ischemic effect will begin immediately after implantation of the device. In some cases, it may be advantageous to leave the flared ends at least partially uncovered because having the exposed metal struts of the device in direct contact with the vessel wall may have a smaller inflammatory response than having the covered material engage the tissue.

[0106] Fig.11A3 The bottom figure in FIG. 11A shows an example in which the covered portion of the frame is only in the middle section 2100, while the upstream end 2120 and the downstream end 2110, such as the flared trumpet end, remain uncovered so that the exposed metal engages adjacent tissue. One of ordinary skill in the art will understand that the amount of coverage can be adjusted to provide a desired flow rate, pressure gradient, or back pressure. In any example, the cover can cover the central 1 / 3, 1 / 2, or 2 / 3 of the device. Other aspects of the example shown in FIG. 11A can generally take the same form as disclosed elsewhere in this specification.

[0107] Figures 11B1 to 11B3 The sequence of schematic diagrams in illustrates a delivery system for a flow altering device. Fig.11B1 The top schematic diagram in shows a delivery catheter that may include an outer sheath 2130 and an inner shaft. The flow altering device may be crimped or otherwise loaded onto the inner shaft, and then the outer sheath is advanced over the flow altering device to constrain the flow altering device. Fig.11B2In the embodiment, once the device is delivered to the desired target treatment site, the sheath 2130 is retracted. This removes constraints on the flow altering device, allowing it to self-expand to the treatment site. The flared end helps to anchor the device in place. Fig.11B3 In the embodiment of the present invention, the sheath 2130 is fully retracted, thereby allowing the flow altering device 2140 to fully expand radially into position. The catheter can then be removed from the patient, leaving the flow altering implant 2140 in the treatment area. This method of delivering a flow altering implant can be used with any of the flow altering devices disclosed herein. In other examples of delivery systems, the delivery system can include an expandable member, such as a balloon that is configured to expand the flow altering implant balloon rather than being self-expanding.

[0108] Fig. 11C The diagram shows the general use of Fig.10 Another example of a flow altering implant of the same form as in the above, except that instead of a plurality of interconnected struts, the implant is formed of a plurality of interwoven filaments forming a mesh, which mesh is then formed into a flow altering device, and the flow altering device is similar to the previous Fig.10 The flow altering device is substantially the same as the flow altering device described in . The mesh may include a narrow middle region 2050 and two flared regions, namely, a proximal flared region 2010 and a distal flared region 2020. The flow altering device may be delivered using any of the methods disclosed herein and also have similar results in terms of altering flow and treating angina as previously disclosed.

[0109] Fig.11D The flow changing device implanted in the blood vessel 2150 is illustrated. The flow changing device can be any of those disclosed herein, and the blood vessel is the coronary sinus, the main vein that drains venous blood from the heart. As shown, the device changes the flow through the device by utilizing a smaller diameter intermediate region 2165, thereby forming a pressure gradient in which the upstream pressure is higher than the downstream pressure. As previously discussed, this can produce back pressure, which helps to redistribute blood to more needed areas of the myocardium or can stimulate collateral vessel formation or angiogenesis, thereby relieving angina. The proximal flared end 2160 can have a diameter larger than the diameter of the distal flared end 2155, or the distal flared end 2155 can have a diameter larger than the diameter of the proximal flared end 2160, or the proximal flared end 2160 and the distal flared end 2155 can have the same diameter. The device can be delivered using any of the delivery systems and methods disclosed herein.

[0110] Fig.12 An example of a flow altering implant is shown. An expandable frame and Fig.10The frame of is substantially the same, but can be any of those disclosed herein. Coverings 2185 and 2190 are then coupled to the frame at the proximal and distal ends. The covering can be any material including, but not limited to, fabric, polymer, tissue, or anything else. Examples of polymers include, but are not limited to, PTFE, ePTFE, DACRON, polyurethane, and the like. Examples of tissue include, but are not limited to, pericardial tissue or other tissue. The middle section 2200 of the frame remains uncovered, and the proximal and distal ends 2170, 2180 of the device also remain uncovered. Composite implants may also be provided and implanted. For example, multiple rings or tubular elements may be coupled together to form a flow altering implant. Each ring or tubular element may have a different geometry or structure, or may be formed from different materials. For example, Fig.12 It can be modified so that the material and structure of the covering 2190 can be different from the material and structure of the covering 2185, and there may or may not be a tubular support ring disposed under these sections. Additionally, the covering 2190 or 2185 may not be porous, so there is no risk of blood flow through the side holes in these sections, and therefore a "cover" is not actually needed. Alternatively or additionally, the covering 2190 and the covering 2185 may not be a covering, but a part of the structure of the device. For example, the coverings 2190 and 2180 may be ring sections that are coupled together by the middle section 2200 and are also coupled to the most proximal ring and the most distal ring. The coverings 2190 and 2180 used as ring sections may be fabric, metal, or a combination thereof. Alternatively or additionally, the ring members 2180, 2200, and 2170 may be fabric, metal, or a combination thereof. The implant may include different materials and sections coupled together. For example, ring 2180 can be a metal ring component coupled to ring 2190, which can be a fabric component coupled to ring 2200, which can also be a metal component. In any of the examples discussed herein, the material forming the covering 2190, 2185 or composite ring segments can be porous, semi-porous, or non-porous. Optionally, in any of the examples, the covering 2190, 2185 can have discontinuous segments within a single ring that are porous, semi-porous, or non-porous, so that the material has a variety of properties. It should be understood that in any of these examples, the material forming the covering itself can include more than one material. In this example, the upstream end has a flare diameter that is smaller than the downstream flare diameter to accommodate natural vascular tapering. However, this is not intended to be limiting, and the upstream end can have a diameter that is larger than or equal to the diameter of the downstream end. The flow altering implant can be delivered using any of the delivery devices and methods disclosed herein, and other aspects of the device are similar to those described herein. Fig.10 The aspects described in are substantially the same.

[0111] FIG. 15A to FIG. 15F An example of a cover disposed on an inflow end or an outflow end of a flow altering device, including any of those disclosed herein, is illustrated. Fig.15A 6, a cover 602 is disposed on an inflow end 606 of the device 600. Here, the cover 602 extends from an edge 604 of the inflow end toward the opposite end of the device, but ends at a tapered portion of the inflow end and does not extend beyond the midpoint of the device along the longitudinal axis of the device.

[0112] exist Fig. 15B 6, the cover 602 is still disposed on the inflow end 606 of the device 600, however here the cover does not extend all the way to the edge of the inflow end and thus there the edge of the inflow end remains uncovered. The cover then extends towards the opposite end of the device but still ends at the tapered portion of the inflow end and does not extend beyond the midpoint of the device along the longitudinal axis of the device.

[0113] The cover may extend from any point on the inflow end and towards any point along the device. Fig. 15C It is shown that the covering may begin at edge 604 of the inflow end of device 600, or the covering may begin anywhere along taper 608 and extend along the longitudinal axis of the device toward midpoint 610 of the device or even beyond midpoint 612.

[0114] exist Fig.15D In the embodiment of the present invention, a cover 614 is provided on the outflow portion of the device 600. The cover 614 may start from the edge 616 and extend toward the opposite end of the device, but the terminating edge may still be on the tapered portion 616a of the outflow end.

[0115] exist Fig.15E In the figure, a cover 614 is disposed on the outflow end of the device 600, but the cover does not extend all the way to the edge 616 of the outflow end, and the opposite end extends along the longitudinal axis of the device toward the midpoint of the device, but still ends at the tapered portion 616a of the outflow end.

[0116] The cover may extend from any point on the outflow end of the device 600, such as Fig.15F For example, the cover may be disposed on edge 616 of the outflow end, or the cover may begin at tapered portion 616a of the outflow end and extend along the longitudinal axis of the device toward midpoint 618 of the device, or may extend beyond midpoint 620.

[0117] In any of the examples disclosed herein, the covering may be a fabric such as DACRON, or a polymer such as silicone, or the covering may be a tissue such as pericardial tissue. The covering may be coupled to the device with sutures, adhesives, or other techniques known in the art.

[0118] FIG. 13A to FIG. 13B Illustration of basic human heart anatomy. Fig.13A , the left atrium LA, the right atrium RA, the left ventricle are shown together with the coronary sinus CS. The coronary sinus is the main vein that drains venous blood away from the heart.

[0119] Fig. 13B The left and right atria LA and RA are highlighted, as well as the area surrounding the left ventricle LV, including the coronary sinus CS and inferior vena cava IVC.

[0120] FIG. 14A to FIG. 14C An example of a method of delivering a flow altering implant to the coronary sinus CS as a treatment for angina pectoris using any of the implants disclosed herein is illustrated.

[0121] exist Fig.14A In the embodiment of the present invention, a delivery catheter 2300, such as any of those disclosed herein, is used to advance a flow altering implant (any of those disclosed herein) to the coronary sinus CS. The delivery catheter 2300 has a crimped flow altering implant 2320 coupled to the delivery catheter. The flow altering implant can be any of those disclosed herein.

[0122] exist Fig. 14B In the embodiment of the present invention, the balloon 2330 on the delivery catheter 2300 is radially expanded, thereby expanding the flow altering implant 2310. The flow altering implant 2310 takes on a size and shape similar to the size and shape of the balloon that expands the flow altering implant 2310.

[0123] exist Fig. 14C In the embodiment of the present invention, the balloon expands the flow altering device to engage the coronary sinus vessel wall. The balloon is then deflated and removed from the vessel, leaving the flow altering device 2310 at the target treatment site.

[0124] Any of the flow altering devices described herein may be balloon expandable or self-expanding.The flow altering devices may be placed in any target treatment area, such as in a blood vessel like the coronary sinus.

[0125] Notes and Examples

[0126] The following non-limiting examples illustrate certain aspects of the inventive subject matter to address the challenges and provide the benefits discussed herein and others.

[0127] Example 1 is a flow changing device, comprising: a plurality of struts, the plurality of struts being connected together to form a radially expandable frame having a proximal end and a distal end, wherein the proximal end and the distal end are capable of radially expanding into an expanded proximal end and an expanded distal end; a diameter reducing portion of the expandable frame, the diameter reducing portion being disposed between the expanded proximal end and the expanded distal end, wherein the diameter reducing portion includes a fluid flow channel; and a covering, the covering being disposed on at least a portion of the radially expandable frame, wherein the diameter reducing portion changes the fluid flow passing through the flow changing device immediately after the flow changing device is implanted, and forms a pressure gradient between the inflow end and the diameter reducing portion.

[0128] Example 2 is the device of Example 1, wherein the pressure gradient is greatest between the inflow end of the device and the reduced diameter portion.

[0129] Example 3 is any of the devices of Examples 1-2, wherein a velocity of the fluid flow is greatest in the reduced diameter portion.

[0130] Example 4 is any of the devices of Examples 1 to 3, wherein the expanded proximal end and the expanded distal end are flared ends.

[0131] Example 5 is any of the devices of Examples 1 to 4, wherein the radially expandable frame has an outer surface, and wherein the covering is disposed only on a portion of the outer surface.

[0132] Example 6 is any of the devices of Examples 1 to 5, wherein the radially expandable frame has an outer surface, and wherein the covering is disposed on the entire outer surface.

[0133] Example 7 is any of the devices of Examples 1 to 6, wherein the cover is disposed only on the reduced diameter portion.

[0134] Example 8 is any of the devices of Examples 1 to 7, wherein the expanded proximal end and the expanded distal end remain at least partially uncovered.

[0135] Example 9 is any of the devices of Examples 1 to 8, wherein the covering comprises a polymer, a fabric, a synthetic material, a tissue, or a combination thereof.

[0136] Example 10 is any of the devices of Examples 1 to 9, wherein the cover is centrally disposed on at least 2 / 3 of the expandable frame.

[0137] Example 11 is any of the devices of Examples 1 to 10, wherein the covering is positioned on the reduced diameter portion so that when the flow altering implant radially expands to engage a blood vessel, the covering does not directly contact the blood vessel, thereby altering or preventing an inflammatory response.

[0138] Example 12 is any of the devices of Examples 1 to 11, the device of claim 1, wherein the covering is configured to prevent or minimize an inflammatory response caused by a blood vessel wall.

[0139] Example 13 is any of the devices of Examples 1 to 12, the device of claim 1, wherein the reduced diameter portion comprises a diameter between 2 mm and 4 mm.

[0140] Example 14 is any of the devices of Examples 1 to 13, wherein, when the expandable frame is in a contracted configuration, the plurality of struts form a plurality of rectangular slots, and wherein, when the expandable frame is in a radially expanded configuration, the plurality of rectangular slots expand into a diamond shape, and wherein the diamond shape has a height and a length, and wherein the height decreases from the proximal end and the distal end toward a center point disposed between the proximal end and the distal end.

[0141] Example 15 is any of the devices of Examples 1 to 14, wherein the length decreases from the proximal end and the distal end toward the center point.

[0142] Example 16 is any of the devices of Examples 1 to 15, wherein the flow altering device is self-expanding or balloon expandable.

[0143] Example 17 is any of the devices of Examples 1 to 16, further comprising an inflow end and an outflow end, and wherein the cover is disposed only on the inflow end, or only on the outflow end.

[0144] Example 18 is a system for delivering a flow altering implant, the system comprising: a flow altering implant according to any one of Examples 1 to 17; and a delivery catheter.

[0145] Example 19 is a method for changing flow in a blood vessel, the method comprising: providing a flow changing device comprising a proximal end and a distal end; delivering the flow changing device to a target treatment area in the blood vessel; radially expanding the flow changing device so that the diameters of the proximal end and the distal end are larger than the diameter of a reduced diameter portion disposed between the proximal end and the distal end; immediately changing the blood flow passing through the flow changing device after delivery of the flow changing device, thereby forming a pressure gradient between the inflow end of the flow changing device and the reduced diameter portion, and wherein a covering disposed on the flow changing device promotes changes in blood flow.

[0146] Example 20 is the method of Example 19, further comprising maximizing the velocity of the fluid flow in the reduced diameter portion.

[0147] Example 21 is any of the methods of Examples 19 to 20, wherein radially expanding the flow altering device includes forming flared regions at the proximal end and the distal end.

[0148] Example 22 is any of the methods of Examples 19 to 21, wherein radially expanding the flow altering device includes expanding the cover, the cover being disposed on only a portion of an outer surface of the flow altering device.

[0149] Example 23 is any of the methods of Examples 19 to 22, wherein radially expanding the flow altering device includes expanding the cover, the cover being disposed over an entire outer surface of the flow altering device.

[0150] Example 24 is any of the methods of Examples 19 to 23, wherein radially expanding the flow altering device comprises expanding the cover, the cover being disposed only on a central region.

[0151] Example 25 is any of the methods of Examples 19 to 24, wherein radially expanding the flow altering device comprises expanding the covering, wherein the proximal end and the distal end remain at least partially uncovered.

[0152] Example 26 is any of the methods of Examples 19 to 25, wherein radially expanding the flow altering device comprises expanding the covering out of direct contact with the blood vessel, thereby altering or preventing an inflammatory response.

[0153] Example 27 is any method of the methods of Examples 19 to 26, wherein the radially expanding flow changing device includes forming a rhombus-shaped unit from rectangular-shaped units, and wherein the height of the rhombus-shaped unit decreases from the proximal end and the distal end toward a center point disposed between the proximal end and the distal end.

[0154] Example 28 is any of the methods of Examples 19 to 27, wherein the rhombus-shaped unit has a length, and the length decreases from the proximal end and the distal end toward the center point.

[0155] In Example 29, the apparatus or method of any one or any combination of Examples 1 to 28 can optionally be configured so that all elements of the listed options can be used or selected therefrom.

[0156] The above detailed description includes reference to the accompanying drawings that form a part of the detailed description. The accompanying drawings show specific examples that can practice the present invention by way of illustration. These examples are also referred to as "examples" in this article. Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. In addition, the inventors also contemplate examples using any combination or arrangement of those elements (or one or more aspects of elements) shown or described with respect to a specific example (or one or more aspects of a specific example) or with respect to other examples shown or described in this article (or one or more aspects of other examples).

[0157] In the event of an inconsistency in usage between this document and any document incorporated by reference, the usage of this document controls.

[0158] In this document, the terms "a" or "an" are used to include one or more than one as is common in patent documents, regardless of any other instances or uses of "at least one" or "one or more". In this document, unless otherwise stated, the term "or" is used to refer to a non-exclusive or, such as "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "including" and "in..." are used as the plain English equivalents of the corresponding terms "including" and "wherein". In addition, in the appended claims, the terms "including" and "comprising" are open-ended, that is, a system, device, article, composition, formula or process that includes elements other than those listed after the term in the claim is still considered to fall within the scope of the claim. In addition, in the appended claims, the terms "first", "second", and "third", etc. are used only as labels and are not intended to impose numerical requirements on their objects.

[0159] The above description is intended to be illustrative, rather than restrictive. For example, the above examples (or one or more aspects of the examples) can be used in combination with each other. Other examples can be used, for example, by a person of ordinary skill in the art after reading the above description. An abstract is provided to allow the reader to quickly determine the nature of the technical disclosure. The abstract is submitted with the following understanding, that is, the abstract will not be used to interpret or limit the scope or meaning of the claims. In addition, in the above detailed description, various features can be combined together to simplify the disclosure. This should not be interpreted as meaning that the disclosed features that are not claimed for protection are essential to any claim. On the contrary, the subject matter of the present invention can be less than all the features of a specific disclosed example. Therefore, the attached claims are incorporated into the detailed description as an example or multiple examples, wherein each claim exists independently as a separate example, and it is envisioned that these examples can be combined with each other in various combinations or arrangements. The scope of the present invention should be determined with reference to the attached claims and the full scope of the equivalents given by these claims.

Claims

1. A flow changing device, comprising: a plurality of struts coupled together to form a radially expandable frame having a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion are radially expandable into an expanded proximal end portion and an expanded distal end portion, wherein the flow altering device extends from an inflow end of the radially expandable frame to an outflow end of the radially expandable frame; a reduced diameter portion of the radially expandable frame, the reduced diameter portion disposed between the expanded proximal end portion and the expanded distal end portion, wherein the reduced diameter portion includes a fluid flow passageway; and a cover disposed over at least a portion of the radially expandable frame, the cover having an upstream end and a downstream end, the upstream end being spaced downstream from an edge of the inflow end portion of the radially expandable frame, and the downstream end being spaced upstream from the reduced diameter portion of the radially expandable frame such that the cover is located only over a flared portion of the distal end portion, wherein the reduced diameter portion changes the fluid flow through the flow altering device immediately after implantation of the flow altering device, and forms a pressure gradient between the inflow end of the flow altering device and the reduced diameter portion.

2. The flow changing device according to claim 1, wherein: The pressure gradient is greatest between the inflow end and the reduced diameter portion of the flow altering device.

3. The flow changing device according to claim 1, wherein: The velocity of the fluid flow is greatest in the reduced diameter portion.

4. The flow changing device according to claim 1, wherein: The expanded proximal end portion and the expanded distal end portion are flared portions.

5. The flow changing device according to claim 1, wherein: The radially expandable frame has an inner surface, and wherein the covering is disposed on only a portion of the inner surface.

6. The flow changing device according to claim 1, wherein: The radially expandable frame has an outer surface, and wherein the covering is disposed on only a portion of the outer surface.

7. The flow changing device according to claim 1, wherein: The covering comprises a polymer, a fabric, a synthetic material, a tissue, or a combination thereof.

8. The flow changing device according to claim 1, wherein: The covering is configured to prevent or minimize an inflammatory response caused by the vessel wall.

9. The flow changing device according to claim 1, wherein: The reduced diameter portion comprises a diameter between 2 mm and 4 mm.

10. The flow changing device according to claim 1, wherein: When the radially expandable frame is in a contracted configuration, the plurality of struts form a plurality of rectangular slots, and wherein, when the radially expandable frame is in a radially expanded configuration, the plurality of rectangular slots expand into a rhombus shape, and wherein the rhombus shape has a height and a length, and wherein the height decreases from the proximal end portion and the distal end portion toward a center point disposed between the proximal end portion and the distal end portion.

11. The flow changing device according to claim 10, wherein: The length decreases from the proximal end portion and the distal end portion toward the center point.

12. The flow changing device according to claim 1, wherein: The flow altering device is self-expanding or balloon expandable.

13. The flow changing device according to claim 4, wherein: The cover is tapered from the upstream end to the downstream end.

14. The flow changing device according to claim 1, wherein: The outflow end has a larger diameter than the inflow end.

15. A system for delivering a flow-modifying implant, the system comprising: The flow changing device according to claim 1; as well as Delivery catheter.

16. A flow changing device comprising: a plurality of struts coupled together to form a radially expandable frame having a proximal end portion and a distal end portion, wherein the proximal end portion and the distal end portion are radially expandable into an expanded proximal end portion and an expanded distal end portion, wherein the flow altering device extends from an inflow end of the radially expandable frame to an outflow end of the radially expandable frame; a reduced diameter portion of the radially expandable frame, the reduced diameter portion disposed between the expanded proximal end portion and the expanded distal end portion, wherein the reduced diameter portion includes a fluid flow passageway; and a cover having an upstream end and a downstream end located on the distal end portion; wherein the reduced diameter portion changes the flow of fluid through the flow altering device immediately after implantation of the flow altering device and forms a pressure gradient between the inflow end of the flow altering device and the reduced diameter portion; and Therein, the outflow end has a larger diameter than the inflow end.

17. The flow altering device of claim 16, wherein: The cover is tapered from the upstream end to the downstream end.

18. The flow changing device according to claim 16, wherein The cover is located only on the flared portion of the distal end portion.

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