Tissue distention device and related methods for therapeutic intervention

The present invention relates to devices that can be positioned within the lumen of a vessel with flexible sidewalls or within the opening of a flexible membrane, especially within the opening of patent foramen ovale. The device extends or urges the opposing portions that define the opening or form the side wall of the tube outward in the plane of the device. The outward urging causes the facing portion of the opening or side wall to be pulled inward in a direction perpendicular to the device plane, juxtaposed or brought into contact.

Resilient membranes, especially living tissues such as muscle tissue, suffer from defects, disorders or diseases, penetrating or forming unwanted openings or cavities within the tissue. It may end up. Elastic tubes with flexible sidewalls are widespread throughout the human body, such as the transfer and distribution of blood to tissues and the transport of waste matter from the digestive and urinary systems. It fulfills various biological functions. The tube may also use sphincter muscles to control the flow of material through the tube and include a one-way valve to prevent backflow of fluid. The valve, or even the tube itself, can fail to function properly due to injury, disease or abnormality. Some of the various diseases of important muscle tissue and blood vessels are illustrated below.

Mitral Valve Incompetence As shown in FIG. 1, the left atrioventricular valve, or mitral valve 2, is a bi-leaflet valve located at the orifice 4 between the left ventricle 8 and the left atrium 6 of the heart 10. Oxygen-rich blood flows from the lungs through the pulmonary veins through the left atrium 6 and through the mitral valve 2 into the left ventricle 8. Blood is then pumped into the aorta 16 and further distributed to the body. The mitral valve 2 has leaflets 18 and 20, which are juxtaposed with each other so that the surface of the valve parallel to the leaflets is defined between the leaflets. The mitral valve 2 is a one-way valve that allows leaflets 18 and 20 to move away from each other in a direction perpendicular to the valve plane 22 to allow inflow into the left ventricle 8. They then approach each other (also known as "union") in response to the pressure buildup that occurs within the left ventricle 8 as the left ventricle 8 contracts to pump blood through the aorta 16. In a healthy valve, the leaflets usually seal (fuse) each other, blocking regurgitation into the lungs through the left atrium 6. However, in diseased mitral valves, leaflets cause a prolapse into the left atrium, allowing blood to regurgitate.

Of the various valves in the heart, the mitral valve is the most susceptible to disease, and the failure of the bicuspid valve results in incomplete sealing of the mitral valve. This allows blood to flow back into the left atrium in response to the contraction of the left ventricle. Diseased valve leaflets are injured and shortened, which is one cause of valvular insufficiency. Other causes include chordae tendineae (chordae tendineae attached to the free end of the leaflet to prevent prolapse), and retraction, rigidity and deformation associated with rheumatic carditis. ..

Due to the low success rate of mitral valve replacement, bicuspid valve insufficiency is preferably treated by repair of the mitral valve requiring cardiotomy. This procedure is highly invasive, requires cardiac arrest and cardiopulmonary bypass for the patient, and often causes postoperative complications.

Venous Valve Incompetence As shown in FIG. 2, vein 24 of the human circulatory system has a system of unidirectional valves as shown in 26 and 28, with two leaflets 30 and 32. They work to facilitate the flow of blood from the end to the heart while blocking the backflow of blood to the end between heartbeats. The venous valves 26 and 28 also work together to allow muscle movement to help pump blood back to the heart from the venous side of the circulatory system. The contraction of various muscles 34 tends to cause the contraction of veins, which causes blood to drain from the veins. The venous valves 26 and 28 work together to open the valve 28 when the valve 26 remains closed, allowing only one-way flow back to the heart.

Veins can suffer from a variety of diseases associated with defects in the structure and function of their valves, known as valvular insufficiency. In addition to causing varicose veins, valvular insufficiency also causes chronic venous insufficiency, in which the thick and contracted valve leaflets make it impossible to block blood reflux. Both of these conditions can cause great discomfort, as well as edema, erythema, dermatitis, skin ulceration and cellulitis. Is.

Arterial Saccular Aneurysms As shown in FIG. 3, the small saccular aneurysm 36 is a sac-like formation of the arterial wall 42 that occurs at the bifurcation 38 of the arterial 40 of the body, outward from the bifurcation 44 between the arterial branches 40. It is postponed. The aneurysm 36 has a reduced diameter neck 46 that forms a connection with the artery 40 and is capped by a dome 48. During the process of aneurysm formation, the intra-arterial elastic plate disappears from the site of the neck 46, the wall 42 becomes thin and brittle, and connective tissue replaces smooth muscle cells. The aneurysm is fragile at the site of the dome 48, resulting in bleeding.

Rupture of a small saccular aneurysm of a cerebrovascular disease has a high mortality rate (within 10% on the first day of rupture and 25% within 3 months) and is a significant nerve even in those who survive the initial major bleeding. It is especially serious because it suffers from disability.

Patent Foramen Ovale As shown in FIG. 1, foramen 3 is the opening of muscle tissue between the left and right atriums of the heart (signs 6 and 7, respectively). This opening exists to allow blood flow between the mother and the foetation before birth. After birth, hole 3 is usually occluded to separate the atrium, allowing the infant's heart to pump blood. Patent foramen ovale is a defect in the heart that does not occlude the hole even after birth, allowing blood to leak between the atria. This defect increases the risk of pulmonary embolism and stroke.

Atrial Appendage FIG. 1B is a partial cross-sectional view along line 1B-1B in FIG. 1, showing the atrial appendage 5 extending from the left atrium 6 and adjacent to the pulmonary trunk 9. The atrial appendage 5 is approximately the size of a human thumb, and its useful function is unknown. However, it is responsible for the formation of blood clots, which is believed to be responsible for 90% of attacks associated with non-rheumatic atrial fibrillation or arrhythmias. The risk of cerebral infarction is greatly reduced by closing the cardiac ear 5 with respect to the left atrium 6.

Atrial and Ventricular Septal Defects The atrial septal defect shown in FIG. 1C is characterized by the septum that separates the left atrium 6 and the right atrium 7, the opening 13 of the wall 15. Similarly, ventricular septal defect is characterized by an opening 17 in the septum 19 that separates the left ventricle 8 and the right ventricle 11. Such an opening allows blood to flow between the atria or between the ventricles.

If untreated, the atrial septal defect stresses the right ventricle and weakens it by tensioning it. The lungs will also become hyperemic, which can also lead to pulmonary hypertension and blood clots that lead to arrhythmias and stroke. Ventricular septal defect also stresses the right ventricle, which also leads to hyperemia, pulmonary hypertension, thrombosis, stroke and arrhythmias.

<p> Thus, it can be used to cure openings in muscle tissue and tube-related disorders and abnormalities with flexible and elastic sidewalls, especially foramen ovale patency, as well as a safe and minimally invasive technique. There has been a demand for a device and a method that can reduce the impact on the patient and minimize postoperative complications by making it applicable to the patient.</p>

<p> The present invention relates to urging devices that can be positioned within the opening of a membrane such as muscle tissue or within the lumen of a tube with flexible side walls. The device urges the first opposing side wall portions outward from each other in its plane, while pulling the second opposing side wall portions closer to each other in a direction substantially perpendicular to the plane of the device. The urging device can be inserted through a catheter into an opening or lumen. In a preferred embodiment, the device comprises a pair of elastic, flexible legs extending from a common endpoint. The legs can be elastically deformed into a first shape that slides into the catheter when they are located close to each other and a second shape that is positioned apart from each other.</p><p> The first and second anchor bases are preferably arranged along the length direction of each leg at a portion away from the common end point. The anchor substrate is formed of a plurality of filamentous members attached to the legs. The anchor substrate defines a plurality of gaps between the plurality of filamentous members. The anchor base on each leg engages the first opposing side wall as the leg takes a second shape in the tube. At this time, the leg portion urges the first facing side wall portion outward, so that the second side wall portion is pulled inward.</p><p> In another embodiment, the invention comprises a pair of elastic and flexible legs that form a closed loop by having opposing ends that connect to each other at the first and second common endpoints. .. The legs can be elastically deformed into a first shape that slides into the catheter when they are located close to each other and a second shape that is positioned apart from each other.</p><p> The first and second anchor bases are preferably located opposite each other across the loop along the length direction of each leg. These anchor substrates are also formed from a plurality of filament-like members attached to the legs, and the plurality of filament-like members define a plurality of gaps. The anchor base on each leg engages the first opposing side wall as the leg takes a second shape in the tube. The leg portion urges the first facing side wall portion outward, so that the second side wall portion is pulled inward.</p><p> The device according to the invention includes a shroud, which can cover the leg segments and provide a central layer connecting the leg segments. The shroud is preferably formed from interwoven filamentous members and provides a matrix that promotes inward growth of living tissue so that the device is secured to the tissue. .. The shroud also provides a substrate for attaching the tissue to the tissue so that the tube or opening is permanently sealed.</p><p> The present invention also includes disorders and defects including patent foramen ovale, atrial appendage, atrial and ventricular septal defect, regurgitation mitral valve, cystic aneurysm, by using the urging device according to the invention. Includes methods of treating other disorders associated with tubes with flexible sidewalls. The method is (A) Steps to position the leg of the urging device within the tube or opening, such as the opening surface of the valve, the neck of a small saccular aneurysm or the opening between the left and right atria, (B) By urging the legs that are separated from each other so that the legs urge the opening or the first facing part of the tube outward, for example, the leaflet of the valve, the aneurysm. A step that allows the neck or side walls, such as the opposing sides forming the opening, to be pulled in a juxtaposed direction. To have.</p><p> When treating the valve, the legs are coplanar with the surface of the valve. If there is an anchor base, the method further comprises the step of engaging the anchor base with the opening or the first facing portion of the tube to position the device on the opening surface of the valve or the neck of the microcystic aneurysm. Eh.</p><p> In one embodiment, the present invention provides a device for urging and juxtaposing an opening or a facing side wall of a tube.</p><p> In other forms, the invention provides a device for controlling the flow of fluid or other material through a tube.</p><p> In yet another form, the invention provides a device for stopping the flow of fluid through a tube or opening.</p><p> In other forms, the invention provides a device for sealing an opening or tube by facilitating a healing reaction between the walls or sections of the tube forming the opening.</p><p> In yet another form, the invention provides a device that can be implanted in the human body through minimally invasive techniques.</p><p> In other forms, the invention provides a device that can be used to correct mitral valve insufficiency.</p><p> In other forms, the invention provides a device that can be used to correct venous valve insufficiency.</p><p> In yet another form, the invention provides a device that can be used to treat a small saccular aneurysm.</p><p> In a further form, the invention provides a device that can be used to correct foramen ovale patency.</p><p> In other forms, the invention provides a device that can be used to correct atrial and ventricular septal defects.</p><p> In other forms, the invention provides a device that can be used to close the atrial appendage.</p><p> In yet another form, the present invention provides a method for urging and juxtaposing an opening or a facing side wall of a pipe.</p><p> In other forms, the invention provides a method for controlling the flow of fluid through a tube.</p><p> These and other objectives and advantages will become apparent by considering the drawings and the detailed description of preferred embodiments.</p>

<figref num="1">FIG. 3 is a partial cross-sectional view of the human heart highlighting the left atrium, left ventricle and the mitral valve that controls blood flow between them.</figref><figref num="1A">It is sectional drawing taken along line 1A-1A of FIG. 1, and shows the urging device which concerns on this invention located in the plane of a mitral valve.</figref><figref num="1B">It is a partial cross-sectional view taken along line 1B-1B of FIG. 1 and shows the atrial appendage.</figref><figref num="1C">It is a partial cross-sectional view of the human heart, showing the left and right ventricles and the atrium.</figref><figref num="2">It is a partial cross-sectional view of the vein of the circulatory system.</figref><figref num="2A">It is sectional drawing taken along line 2A-2A of FIG. 2, and shows the urging device which concerns on this invention located in the venous valve.</figref><figref num="3">It is sectional drawing of the arterial bifurcation part with a small saccular aneurysm.</figref><figref num="3A">It is a cross-sectional view taken along the line 3A-3A of FIG. 3 and shows the urging device according to the present invention located in the neck of a small saccular aneurysm.</figref><figref num="4">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="4A">It is an enlarged plan view which shows the broken line circle part 4A of FIG. 4 in order to show the detail of the design of the device of FIG.</figref><figref num="5">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="5A">FIG. 5 is an enlarged plan view of the dashed circle 5A of FIG. 5 to show the details of the device design of FIG.</figref><figref num="6">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="7">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="8">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="9">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="10">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="11">It is sectional drawing of the urging device of the embodiment of FIG. 10 taken along line 11-11 of FIG.</figref><figref num="12">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="13">It is sectional drawing of the urging device of the embodiment of FIG. 12 taken along line 13-13 of FIG.</figref><figref num="14">It is a top view of the embodiment of the urging device which concerns on this invention.</figref><figref num="15">FIG. 6 is a cross-sectional view of the urging device of the embodiment of FIG. 14 taken along lines 15-15 of FIG.</figref><figref num="16">It is a partially broken perspective view which shows the urging device which concerns on this invention which is in a catheter to supply to a tube in a body.</figref><figref num="17">It is a breaking perspective view of the urging device according to the present invention positioned in the valve.</figref><figref num="18">It is a partially cutaway perspective view of the urging device according to the present invention positioned in the atrial appendage.</figref><figref num="19">FIG. 3 is a perspective view of an urging device suitable for feeding by a guide wire.</figref><figref num="20">It is a perspective view which shows the other embodiment of the urging device suitable for feeding by a guide wire.</figref><figref num="21">It is a top view which shows the embodiment which made the urging device which concerns on this invention removable.</figref><figref num="22">It is a top view which shows the embodiment which made the urging device which concerns on this invention removable.</figref><figref num="23">The device of FIG. 21 that is removed from the flexible tissue is shown.</figref><figref num="24">The device of FIG. 21 removed from the flexible tissue is shown.</figref><figref num="25">It is a perspective view which shows another embodiment of the urging device which was prepared from a tube.</figref><figref num="26">It is a perspective view which shows another embodiment of the urging device which was prepared from a tube.</figref><figref num="27">It is a perspective view which shows the other embodiment of the urging device which was prepared from the tube.</figref><figref num="28">It is a perspective view which shows the other embodiment of the urging device which was prepared from the tube.</figref><figref num="29">It is an end view taken along the line 29-29 of FIG. 28.</figref><figref num="30A">It is a figure which shows the frame of another embodiment of the urging device.</figref><figref num="30B">It is a figure which shows the frame of another embodiment of the urging device.</figref><figref num="30C">It is a figure which shows the frame of another embodiment of the urging device.</figref>

FIG. 4 shows an embodiment of the urging device 50 according to the present invention. The urging device comprises a pair of elastic and flexible legs 52 and 54, which extend from a common endpoint 56. The legs 52 and 54 are preferably formed from a metal such as nitinol, which is compatible with living tissue and has a relatively high yield stress, and has elastic urging properties to allow the device to function properly as described below. I have. Other metals such as stainless steel, titanium and Elgiroy can also be used. Polymers such as polyester, polypropylene, and polytetrafluoroethylene may be used to form the legs.

Anchor bases 58 and 60 are arranged along the length direction of each leg 52 and 54 at a site away from the common endpoint. As shown in detail in FIG. 4A, the anchor substrate 58 is formed of a plurality of filamentous members 62 (not shown in detail, but the same applies to the anchor substrate 60), preferably in a knitted and interwoven state. A plurality of gaps 64 are defined between the plurality of filamentous members 62. Adjusting the denier and weave density of the filamentous member 62 to create gaps 64 sized to facilitate intergrowth of living tissue within anchor substrates 58 and 60. To do. This allows the device 50 to be organically attached to the side wall of the tube into which it is inserted. Here, a polyester monofilament with 60 denier and 120 picks per inch is preferred, which allows for gaps with intersecting dimensions on the order of 0.004 inches. A 60 denier multifilament may be used to produce a more corresponding coverage. This is useful when space is limited, such as when supplying devices.

It is also possible to coat the filamentous member 62 with a number of growth factors such as thrombin, collagen, hyaluronic acid or VEGf to further promote cell elongation. They promote blood coagulation and the integration of living tissues with inert substances. In addition, the rest of the device is coated with antiproliferative agents such as Taxol, Rapamycin and Rapamune to act as a barrier to all growth and to the unwanted tissue of living tissue. It can interfere with adhesion at the site.

Polyester is a preferred material for the filamentous member 62 from the viewpoint that it can be appropriately used for a long period of time as a transplant to humans. Other polymeric materials can be used, including polypropylene, polytetrafluoroethylene and nylon. Gold is particularly preferred because it is possible to use a metal to form the filamentous member, it is compatible with human tissue and has high radiopacity. If the gold filament either constitutes a filamentous member or is in the gap between them, it acts as a marker of radiopaque, so that during and after transplantation. Fluorescence perspective technology and X-ray technology can be used to view the position and orientation of the device 50. Gold coating 66 may be optionally applied to the filamentous members 62 or to the legs 52 and 54 in a predetermined pattern. This makes it possible to determine the orientation and position of the device 50 clearly and quickly.

Filamentous members 62 can be welded, glued or interwoven with the legs 52 and 54 for the purpose of attaching the anchor bases 58 and 60 to the legs. The anchor substrate may have any practical shape, having a flat shape as shown in FIG. 4, and a cylinder coaxially arranged around the legs 52 and 54 as shown in FIGS. 5 and 6. It can also be shaped like a tube, tube or sleeve.

Hooks 68 can be placed on the legs 52 and 54 away from the common endpoint 56 to initially secure the device 50 to living tissue. Preferably, the hook 68 is co-located on each leg 52 and 54 with the anchor bases 58 and 60 and extends outward from the leg to engage the side wall of the tube into which the device 50 is implanted. Have a protrusion to do. The hook 68 engages the side wall to secure the device 50 in place and allow it to function, providing time for the anchor bases 58 and 60 to integrate with the living tissue of the tube.

The urging device 50 has a first shape in which the legs 52 and 54 are positioned close to each other so that they can slide through the lumen of the catheter, and the legs are positioned apart from each other in FIG. 4. It can be elastically deformed to the second shape shown. Preferably, the legs 52 and 54 are elastically urged to take a shape that separates them from each other in the absence of externally acting binding forces (such as those that occur when the device 50 is inside the catheter). ing. This makes it possible to expand the device and engage it with the side wall of the tube under the action of the elastic urging force at a position released from the catheter as described below.

FIG. 5 shows the urging device 70 according to another embodiment of the present invention. The device 70 has legs 52 and 54, which consist of two segments, respectively. The segments 72 and 74 are connected to each other at the common endpoint 56 and oriented at an angle to each other, forming the first segment of each of the legs 52 and 54, respectively. Segments 76 and 78, which are connected to segments 72 and 74, respectively, form the second segment. The segments 76 and 78 extend substantially parallel and are separated from each other when the legs are in the separated shape shown. As shown in FIG. 5A, device 70 has an anchor substrate as indicated by hook 68 and reference numeral 58. The anchor base 58 is formed by a filamentous member 62 that is braide or weave into a tubular sleeve, which allows living cells to bite into the device 70 in living tissue. It forms a gap 64 to promote. The same applies to the anchor substrate 60, so this is not shown in detail. With reference to FIG. 5 again, the leg segments 72 and 74 are connected to each other by a stress relaxation loop 80 located at the site of the common endpoint 56. The stress relaxation loop 80 has a predetermined radius of curvature 82, which reduces the stress on the leg segments 72 and 74 when the legs are deformed into shapes that are close to each other.

FIG. 6 shows the urging device 80 according to still another embodiment of the present invention. Here, the legs 52 and 54 are welded together by welds 86, rather than being connected together at a common endpoint 56.

7, 8 and 9, respectively, show urging devices 88, 90 and 92 according to a further embodiment of the present invention. The urging device 88 according to the embodiment of FIG. 7 has legs 52 and 54 divided into three segments, respectively. The first segments 94 and 96 are connected to each other at the first common endpoint 98. The second segments 100 and 102 are connected to the ends of the first segments 94 and 96, respectively, and are oriented in parallel so as to be separated from each other. Anchor bases 58 and 60 and hook 68 are properly placed in the second leg segments 100 and 102. The third leg segments 104 and 106 are connected to the second segments 100 and 102, respectively, and are connected and integrated with each other at the second common endpoint 108. The leg segments 94, 96, 100, 102, 104 and 106 are integrated to form a closed loop 110.

The urging device 90 according to the embodiment of FIG. 8 has leg segments 112 and 114 in tilted orientation, which are connected to each other at a common endpoint 116. At the site of the common endpoint 116 is a stress relaxation loop 118 with a predetermined radius 120 connecting the leg segments 112 and 114. The parallel oriented leg segments 122 and 124 are connected to the ends of the angularly oriented segments 112 and 114, respectively. Anchor bases 126 and 128 are placed on leg segments 122 and 124 in parallel orientation, respectively, and hook 130 is also placed with the anchor base. A pair of other angled leg segments 132 and 134 extend from parallel oriented soot segments 122 and 124, respectively. The tilted leg segments 132 and 134 are connected to each other at other common endpoints 136, for example by welding, thereby forming a closed loop 123.

FIG. 9 shows the urging device 92 according to another embodiment of the present invention, respectively. The urging device 90 according to the embodiment of FIG. 9 has leg segments 140 and 142 oriented at an angle, which are joined to each other at a common endpoint 144, for example by welding. Parallel-oriented leg segments 146 and 148 extend from angularly oriented segments 140 and 142, respectively. Anchor bases 150 and 152 are placed in parallel oriented leg segments 146 and 148, respectively, and hook 154 is also placed with the anchor base. The tilted second leg segments 156 and 158 extend from the angularly oriented segments 122 and 124, respectively, by connecting them to each other at the site of the second common endpoint 160. , A closed loop 162 is formed.

As shown in FIGS. 10 to 15, it is effective to arrange shrouds of various embodiments indicated by reference numerals 188, 190 and 192 around the urging device. The particular form, structure and shape of the shroud follows the particular function of the urging device to act on. Although the urging device of the embodiment shown by reference numerals 88, 90 and 92 includes the shroud of the embodiment shown by reference numerals 188, 190 and 192, respectively, the shroud of any embodiment may be used. It should be understood that it can be used for any of the devices of the embodiment, including the embodiments shown by reference numerals 50, 70 and 84 (see FIGS. 4 to 6), and other not specifically exemplified. It can also be used for the device of the embodiment.

The shrouds 188, 190 and 192 are properly equipped with an interlaced filamentous member 194, which is around the urging device. Interlaces of filamentous members can be made by weaving, knitting or braiding. Further, the filamentous member may have a non-woven structure such as felt. The shroud may be formed using a continuous flexible membrane with a large number of pores over a wide area.

When intended for transplantation into living tissue, filamentous members are formed from biocompatible materials such as polyester, polytetrafluoroethylene, nylon, polypropylene and the like. Also, the filamentous member may be made of a metal such as stainless steel, or expand into a predetermined shape when heated in the body, such as nitinol, an alloy of titanium and stainless steel (such as chronochrome), Elgiroy and MP35N. The shape memory metal may be formed. As the filamentous member forming the shroud, it is also possible to use a bioabsorbable material such as polylactic acid, polyglycolic acid and HCA. Similarly, candidate materials for continuous membrane shrouds include expanded polytetrafluoroethylene, silicone membranes, polyurethane and laser-drilled tubes (discussed below).

The choice of material is determined by the function of the shroud. Healing and inward extension of living tissue (for example, to permanently seal a cavity such as the atrial appendage, or an opening in tissue such as a septal defect, or a tube such as a blood vessel at the base of an aneurysm. When a shroud is used to promote ingrowth), polyester, which promotes a positive healing reaction, is the preferred material. As mentioned above, the filamentous member may be coated with thrombin, collagen, hyaluronic acid or growth factors that promote blood coagulation and cell proliferation.

However, when the shroud acts as a suppression device for controlling the flow through the pipe, for example, a material such as polytetrafluoroethylene is preferable. This is because it does not allow foreign matter to accumulate in the pipe and block it.

FIG. 10 shows an embodiment of the shroud 188 for the urging device 88 (see FIG. 7). The shroud 188 is attached by wrapping a filamentous member 194 around leg segments 94-106. It is also possible that the leg segments are interbraid or interweave with filamentous members. As best shown in FIG. 11, a single central layer 196 connects loops 100 formed by leg segments 94-106. The single central layer embodiment exemplified by Shroud 188 is preferred when the opening or tube should be sealed. A single central layer 196 provides a matrix, which promotes intergrowth of living cells, and when both sides of the opening or tube are juxtaposed with respect to the central layer 196 by the urging device 88, the opening or tube. This is because both sides of the are combined.

FIG. 12 shows a shroud 190 of another embodiment, which is placed on the urging device 90 (see FIG. 8). The shroud 190 is preferably made of a filamentous member 194 formed on a tubular sleeve 198 that surrounds leg segments 112, 114, 122, 124, 132 and 134 by weaving, braiding or knitting. The cross-sectional view shown in FIG. 13 best shows the relationship between the sleeve 198 and the leg segment. The use of shroud 190 in the form of a tubular sleeve is effective in correcting valvular insufficiency in blood vessels. In the absence of a shroud on the urging device, the leg segment exposed to the bloodstream becomes the center of thrombus formation, which can cause a stroke if detached. The shroud 190 provides a matrix that allows blood cells to attach to it, eventually sealing the urging device within living cells. With such a seal, the legs of the device no longer cause a coagulation reaction, thus minimizing or eliminating the risk of blood coagulation and stroke.

FIG. 14 shows a shroud 192 forming a substantially form fitting bag 200, in which an urging device 92 (see also FIG. 9) is enclosed. The bag 200 spans a closed loop 162 defined by leg segments forming the urging device 92. The bag 200 provides two central layers 202 and 204 that are spaced apart from each other on opposite sides of the device 92, as best shown in FIG.

Example of device usage Various usage examples of the device according to the present invention will be described below. It should be understood that the particular embodiments presented and the particular use with respect to their application do not declare or imply any limitation.

Example 1 Repair of the mitral valve FIG. 16 shows an urging device 90 housed within a shroud 190 in the form of an elastically deformed sleeve 198, with leg segments 112, 122 and 132 located near leg segments 114, 124 and 134. The device 90 is fitted and slidable within the lumen 164 of the catheter 166. Given the shape of FIG. 8, the device 90 is elastically urged so that the leg segments 112, 122 and 132 are separated from the leg segments 114, 124 and 134. When released from the catheter 166, the device 90 takes on this isolated shape, but the catheter exerts a binding force to hold the leg segment in an elastically deformed proximity shape. This elasticity of the device allows the device to be transported through the vasculature via a catheter and positioned at the site of implantation without the need for traumatic invasive surgery. The device according to the invention is then released from the catheter using a known method, eg, a push rod, takes a separable shape and urges the flexible sidewall of the tube in which it is located.

FIGS. 1, 1A and 17 show a device 90 positioned within the heart 10 to repair the mitral valve that causes regurgitation. Device 90 has its leg elements 112, 114, 122, 124, 132 and 134 stretched out and is substantially coplanar to plane 22 of valve 2. The meaning of "valve plane" is best represented in FIG. 17, which shows a perspective view of a two-pointed mitral valve with two leaflets 18 and 20 juxtaposed, where plane 22 is It is shown by a dashed line as parallel to the leaflet. As best shown in Figure 1A, the anchor bases 126 and 128 and the hook 130 are muscular. Device 90 is positioned to engage the opposing portions 168 and 170 of annulus), from which leaflets 18 and 20 extend. The device 90 is sized and has a spring constant to urge the muscular ring portions 168 and 170 outward within the valve plane 22. Since the mitral valve 2 acts as a tube with flexible side walls, by urging the opposing ring portions 168 and 170 outward, the leaflet is oriented orthogonal to the valve plane 22 as shown in FIG. Attracted to each other. The proximity of the leaflets 18 and 20 to each other allows them to effectively seal when back pressure from the left atrium 8 is applied. Thus, blood is forced through the aorta 16 (FIG. 1) toward the rest of the body, and there is no regurgitation from the left ventricle 6 to the lungs due to mitral valve 2 dysfunction. The dimensions of the device 90 for mitral valve repair can range from about 1-2 inches in length and 30-40 mm in extended diameter. The range of spring constants that represent the effective urging force for the device to extend the mitral valve is 2-3 lbs / inch. The spring constant is determined by the elastic modulus of the materials that make up the device, and similarly the area moment of inertia is also determined by its cross-sectional shape and area. It should be noted that the shroud sleeve 200 prevents the device 90 from becoming the center of thrombus formation and allows the ingrowth of blood cells that will ultimately envelop the device 90.

Example 2 Repair of venous valve 2 and 2A show the urging device 90 according to the invention implanted in vein 24, which is effective in repairing the incontinent venous valve 26. Similar to mitral valve repair, upon exiting catheter 166 (see Figure 10), device 90 extends the leg segment within vein 24 in a plane flush with plane 22 of valve 26. As shown in FIG. 2A, the valve leaflet 30 is formed by engaging the anchor bases 126 and 128 with the opposing portions 174 and 176 of the vein 24 at the sites of the leaflets 30 and 32 and urging the opposing vein portions outward. And 32 are attracted to each other in a direction orthogonal to the plane 22 of the valve 26. By positioning the leaflets 18 and 20 close to each other, as shown in FIG. 2, the leaflets 18 and 20 rather effectively seal when the muscle 34 exerts back pressure in the vein 24 as indicated by arrow 175. Will be able to do. By repairing the other uncontrollable valve, blood will flow through vein 24 in the desired direction, as indicated by arrow 177.

Example 3 Repair of small saccular aneurysm Figures 3 and 3A show device 90 located in a small saccular aneurysm. The device 90 extends out of the catheter and positions the anchor bases 126 and 128 on the neck 46 of the aneurysm 36. The anchor bases 126 and 128 engage the opposing portions 178 and 180 of the neck 46 and urge them outward to force the opposed portions 182 and 184 of the neck to each other in a direction orthogonal to the plane of device 90. Attract. The urging action of the device 90 on the neck 46 of the aneurysm 36 tightens the neck as shown in FIG. 3 and reduces the influx of blood into the aneurysm. This reduces the pressure in the dome 48, providing a stagnant area in the neck 46 to promote coagulation and finally seal the aneurysm to prevent its rupture. Preferably, the device 90 has a shroud 188 of the embodiment forming a single central layer 196. The central layer 196 provides a matrix in which cells grow from opposite cervical portions 182 and 184, allowing the aneurysm to be permanently sealed and separated from the circulatory system.

Preferred materials for shrouds include monofilament and multifilament polyester threads, which promote a positive healing effect. Further, polypropylene, polytetrafluoroethylene, foamed polytetrafluoroethylene and the like can also be mentioned. It is also possible to use wire mesh such as titanium, nitinol, stainless steel, platinum and elgiloy. A non-woven film made of a silicone film and polyurethane having a particularly perforated tube (described later) shape is also applicable to the present invention. If desired, the shroud can be coated with thrombin, collagen, hyaluronic acid and other growth factors to promote inward cell ingrowth and blood clotting, or taxol, rapamycin, rapamune, etc. It is also possible to prevent internal growth and prevent tissue adhesion by coating with an antiproliferative agent.

Example 4 Atrial and ear closure FIG. 1B shows the atrial appendage 5 located in the left atrium 6 adjacent to the pulmonary trunk 9. In order to effectively close the atrial appendage 5, for example, a urging device designated by reference numeral 88 can be inserted into the atrial appendage 5 and crushing the atrial appendage into the atrium, leading to a stroke, as shown in FIG. Remove the atrial appendage, which is thought to be the cause of coagulation. Insertion of the urging device 88 via a catheter can minimize the application of invasive techniques to enforce this cardiac defect.

Example 5 Treatment of patent foramen ovale and septal defect Openings in the muscular tissue of the heart that allow abnormal blood flow, such as patent foramen ovale (symbol 3 in Figure 1) and atrial and ventricular septal defects (symbols 13 and 17 in Figure 1C). Defects associated with can be treated by inserting the urging device of the present invention into the opening. When the urging device is inserted using a catheter and released from it, the urging device expands. This is done by the elastic urging force of the leg segment or by the unique properties of the shape memory metal that expands into a predetermined shape by heating. The urging device stretches the muscle tissue so that the opposing portions are juxtaposed and brought into contact with each other, or the facing portion of the shroud layer that allows the tissue to grow and permanently seal the opening.

Example 6 Fluid flow control Damage to the esophagus, urethra, and other tubes that guide fluids other than blood can also occur. For example, one cause of gastroesophageal reflux is a decrease in the resting tone of the lower esophageal sphincter between the esophagus and stomach. The lower esophageal sphincter allows gastric acid to flow into the esophagus and damages it, causing discomfort, commonly known as "heartburn." The leaking sphincter can be tightened by positioning the urging device according to the invention within its diameter and extending it, thereby reducing the resting opening size and preventing acid reflux.

By positioning the urging device within the urethral sphincter, it is also possible to treat bladder incontinence. By adjusting the rigidity of the device, it is possible to allow urine flow in a controlled manner and prevent unwanted leaks.

The device according to the present invention can also be used for the conception control method. For women, the urging device can be implanted in the Faropius tube and closed to prevent the egg from passing through the uterus. This transplant is less invasive than tubal ligation and can be undone because the urging device is thought to be removable under certain conditions.

Similarly, for men, positioning the urging device within the vas deferens can effectively block the passage of sperm from the testicles.

The urging devices according to the various embodiments described above and shown in the drawings can be supplied through guide wires as long as they are effective. 19 and 20 show the urging device 90 according to two examples of embodiments adapted to the guide wire 206 for supply. As shown in FIG. 19, the urging device 90 has a lug 208. The lug 208 is mounted offset from the centerline of the urging device and engages the guidewire 206 so that the device 90 slides over the guidewire 206 for accurate and convenient positioning. In FIG. 20, device 90 has an opening 210, in which the opening is positioned along the centerline of the device. The opening 210 receives the guide wire 206 and allows the device to accurately slide along the path formed by the guide wire.

The device according to the invention can be suitable for removably positioning within a flexible wall tube or an opening in a soft tissue. 21 and 22 show the device 212 of the removable embodiment according to the present invention. The device 212 comprises two separable elements, which may be formed, for example, from an upper portion 214 and a lower portion 216. The upper portion 214 has a segment 218, and the segment 218 is provided with a bore 220 for receiving the interfitting segment 222 extending from the lower portion 216. The segment 222 can be held in the bore 220 by friction, or gluing or mutual locking or detenting means, which holds the upper portion 214 and the lower portion 216 to each other as shown in FIG. However, as shown in FIG. 22, the upper portion 214 and the lower portion 216 can be separated by applying a predetermined sufficient force. Each of the upper portion 214 and the lower portion 216 of the device 212 is preferably provided with a barb 224. For removable embodiments, the branches 224 are facing inward with respect to the device 212. As shown in FIG. 23, depending on the orientation of such branches, both the upper portion 214 and the lower portion 216 are connected to each other and within the tube 226 or other flexible tissue while both portions are moving in the same direction. Device 212 is blocked from moving. However, as shown in FIG. 24, when the upper portion 214 and the lower portion 216 are moved in opposite directions as indicated by the arrow 228 in an attempt to separate them from each other, the branch 224 can no longer provide a force to resist movement, but they Being inward, it slides over soft tissue and allows the upper and lower portions 214 to separate from each other and be removed from the tube or tissue originally implanted.

As another example, the urging device according to the present invention can be formed of a thin tube. The tube is preferably made of a shape memory metal such as Nitinol or Elgiroy, but it can also be made of other metals with high elasticity and yield strength such as stainless steel and titanium.

25 and 26 show the urging device 230 according to the embodiment formed of the thin tube 232. As shown in FIG. 25, slots 234 are formed in the tube walls 236 facing each other. Slots can be formed by laser cutting or with a saw or knife blade. A further V-shaped notch is formed in the portion around the tube 90 degrees away from the slot 234 so as to face each other. The device 230 is prepared by extending the tube 232 outwards, which opens the slot 234 as shown in FIG. 26, and the tube wall 236 between the slots forms a segment 240 to form a tube or a tube into which the device is implanted. Engage in tissue and urge or expand it. Expansion of the tube 232 is preferably done with respect to the spindle while heating, which urges the device to the expansion shape shown in FIG. The flexibility and elasticity of the material forming the tube allows the device to be deformed back into a substantially tube shape, which allows it to slide within the catheter and be released from the catheter. Sometimes it expands to the shape shown in FIG. Alternatively, the device may have the tube shape shown in FIG. 25 as a normal shape and may be allowed to yield and expand outward with a balloon after implantation. The V-shaped notch 238 forms a hook that extends outward from the segment 240, and the hook engages with the soft tissue to secure the device in place, similar to the embodiments described above. It will be possible. The tube can be easily guided by the guide wire 206 for accurate positioning by the bore 244 defined by the tube wall 236.

27 and 28 show device 246 of another embodiment, which is formed of tube 248. The tube 248 has a plurality of slots 250, which are preferably asymmetrically formed on opposite sides of the tube wall 252. That is, the slots are not evenly distributed around the tube wall 252. The asymmetric distribution of the slots expands the tube into a flat shape, best shown in FIG. 29, on the opposite slot side of the tube when the area 252b adjacent to the slot area is pulled apart. Part 252a is drawn together. Slots 250 may be configured, interconnected, and shaped to form a finely intricate pattern when the tube 248 expands. The pattern may form a matrix that promotes inward growth of the cell, or the pattern provides rigidity and strength to urge the opening of the tube or tissue outward. It may have a lattice structure to be used.

30A and 30B show the preferred urging device 300, which is particularly suitable for treating patent foramen ovale. As shown in FIG. 30A, device 300 includes a frame 305 with multiple leg segments. The first set of tilted leg segments 310 and 312 are elastically connected to the first collar member 314. The second set, leg segments 316 and 318, is attached to leg segments 310 and 312 with an outward tilt. The leg segments 316 and 318 are attached to a third set of leg segments 320 and 322. The leg segments 320 and 322 tilt inward from the attachment points of the leg segments 316 and 318 and are elastically connected to the second collar member 324. A left atrial anchor 326 and a right atrial anchor 338 extending beyond the frame 305 are provided to secure the device within the opening defined by the foramen ovale. In a preferred embodiment, as shown in FIG. 30A, the left atrial anchor 326 is provided to have the same extent as the leg segments 316 and 318 in the direction of the first collar member and is closer to the first collar member 314. A hook portion 317 is formed in the portion. The right atrium anchor 326 is provided so as to have the same extent as the ends of the leg segments 320 and 322 in the direction away from the second collar member. Both the left atrium anchor 326 and the right atrium anchor 328 extend beyond frame 305. The left atrial anchor is preferably coated with a tantalum coil 329 on a Nitinol wire (not shown), which improves radiation impermeability. Further, by allowing the first color member 314 and the second color member 324 to preferably contain a tantalum marker or a tantalum coating, radiation impermeableness is improved.

In another embodiment, as shown in FIG. 30B, the leg segments 310 and 312 are attached to a portion of the left atrial anchor 326 located away from the hooked end and further, for example by welding, the right atrial anchor 328. Attached to leg segments 320 and 322 in the vicinity of the outward extension of.

In one embodiment, the urging device frame 305 is covered with a shroud 322 created and configured as described above, as shown in FIG. 30C. The shroud permanently seals the cavity by promoting healing and inward extension of living tissue. Preferred materials include polyesters that promote a positive healing reaction. As mentioned above, the filamentous member may be coated with thrombin, collagen, hyaluronic acid or growth factors that promote blood coagulation and cell proliferation.

The urging device is elastically deformable, which allows the device to slide through the lumen of the catheter. For example, when the leg segments 316 and 318 are urged to approach each other, the width of the frame 305 is narrowed so that the first collar member 314 and the second collar member 324 are pushed in opposite directions. When the urging device 300 exits the catheter, the frame 305 expands to a predetermined width. Guide wires can be fed through the centers of the first collar member 314 and the second collar member 324 to facilitate placement of the device 300.

When treating patent foramen ovale, for example, the end of the catheter tube into which the device 300 is inserted is extended from the right atrium to the left atrium through an opening defined by the foramen ovale and the catheter. The end of the is made to extend slightly into the left atrium. For example, a push tube is used to push the device 300 out of the end of the catheter, the hook portion 317 of the left atrial anchor 324 engages the opening with the surrounding left atrial tissue, and the right atrial anchor 328 with the right atrial tissue adjacent to the opening. To be pressed against. As the device 300 exits the opening, the width of the frame 305 widens, expanding the tissue around the opening.

The urging device according to the present invention is an article having a wide range of uses for repairing deformations and openings in tissues having flexible side walls and controlling the flow of fluid through the pipe. And the urging device according to the present invention can also be used to treat or repair disorders of the circulatory system and other systems in the body. These are performed using minimally invasive surgery and do not cause unnecessary injury to the patient.