JP2009508592A - Split type device for inlet protection - Google Patents

Abstract

An intraluminal device for placement in the side branch vessel associated with the main vessel via the inlet region. The intraluminal device includes an anchor portion (104), a cap portion (102), and a connection module (106). The anchor portion of the device is disposed within the side branch vessel, and the cap portion includes a plurality of projecting elements configured to extend into the entry ridge region. The coupling module includes a body and a connector and is configured to provide a large angular shift over a short distance and to absorb some of the linear movement of the cap portion on the anchor portion.
[Selection]
[Fig. 3]

Description

  The present invention relates to an intraluminal device for treatment in the inlet region of a blood vessel.

In today's society, many people suffer from a buildup of plaque layers that cover one or more portions of the coronary blood vessel, which pathology impedes blood flow through the blood vessel. Such accumulation is referred to as coronary artery lesions. In many cases, the disease is treated by placing a medical device or device in the patient to support a re-expanded blood vessel or other lumen in the body after cardiac balloon angioplasty.

For angioplasty, typically an intravascular or intraluminal implant known as a stent is placed in the blood vessel. The stent is usually in the shape of a tube, and has a lattice or connected tube-like structure. A stent is typically placed in a blood vessel in a compressed state and then expanded. The support structure of the stent is designed to prevent premature collapse of damaged blood vessels, weakened by angioplasty. The support structure provided by the stent prevents vascular closure called restenosis, or vasospasm immediately after angioplasty, and promotes healing of damaged vessel walls, a process that takes many months. It is done. Self-expanding and balloon-expandable stents are well known.

During the healing process, inflammation caused by angioplasty and damage due to stent implantation often leads to proliferation and regeneration of smooth muscle cells within the stent, thus leading to partial flow channel closure, or restenosis, resulting in Reduce or eliminate the beneficial effects of angioplasty / stent placement. Also, even when a biocompatible material is used to form a stent, a thrombus may be formed within the newly implanted stent due to the nature of the thrombosis on the stent surface.

While the angioplasty itself is taking place or immediately after the plastic surgery, the current methods of injecting powerful antiplatelet drugs into the blood circulation do not form large thrombi, but at least at the microscopic level of the stent surface There is always thrombosis. Such microscopic thrombosis is believed to play an important role in the early stages of restenosis, as soon as a biocompatible matrix on the stent surface is established, followed by smooth muscle cell attachment. ,Multiply.

There are stent coatings that contain bioactive agents designed to reduce or eliminate thrombosis or restenosis. Such bioactive agents may be dispersed or dissolved in either a biodurable or bioerodible polymer matrix that is attached to the surface of the stent wire prior to implantation. After implantation, the bioactive agent diffuses from the polymer matrix to the surrounding tissue over a period of at least 4 weeks, in some cases over a year. Ideally, the duration of diffusion coincides with the time course of restenosis, smooth muscle cell proliferation, thrombosis, or a combination thereof.

Some coronary artery lesions may develop in branched vessels including coronary artery bifurcations, i.e., main vessels with side branch vessels via the entrance region. Bifurcated lesions can be classified by the location of the lesion in the branched blood vessel. In one example, a type 4a bifurcation lesion may be referred to as a lesion on the main vessel wall proximal to the entrance region.

Treatment of bifurcation lesions, such as type 4a lesions using the conventional methods described above, can result in “pushing” at least a portion of the plaque layer into the side branch. Such an effect, commonly referred to as a “snow removal effect”, can lead to partial occlusion of the side branch, but can be treated by placing one or more additional stents in the branched vessel.

Conventional methods for treating bifurcation lesions include placing a first stent portion in the main branch that covers the side branch, then inflating the “Kissing Ballon” and placing the second stent portion in the side branch. Placing may include the step of configuring a “T-stent” structure. However, in such a method, the T-shaped stent may result in blocking / blocking blood flow from the main vessel to the side branch.

Other stent placement methods and / or specially designed bifurcated stents, such as the Jostent® B stent, the Invertec Bifurcation stent, the AST stent, are relatively large, limited feasibility, limited maneuverability, small diameter vessels May have limited access. In addition, other stent placement methods do not provide adequate coverage for various angle branches.

In one embodiment, the endovascular graft device has an anchor portion having a proximal end, a distal end, and an anchor body connecting the proximal end and the distal end, the anchor body having a radial force. An anchor portion comprising a series of struts configured to exert a force, a cap portion proximal to the anchor portion, and a plurality of projecting elements disposed at a proximal end of the cap portion A connection module located on the proximal side of the anchor portion and on the distal side of the cap portion, the connection module having a module body; and the module At least one compressible cap connector connecting a body to the cap portion; and at least one compressible anchor connector connecting the module body to a proximal end of the anchor portion. No.

In another embodiment, the endovascular graft device has an anchor portion having a proximal end, a distal end, and an anchor body connecting the proximal end and the distal end, the anchor body having a radial direction. An anchor portion including a series of struts configured to exert a force, a cap portion proximal to the anchor portion, and a portion of the linear movement of the cap portion toward the anchor portion And a coupling means arranged between the anchor part and the cap part to absorb the absorbed amount of the linear movement of the cap part from being transmitted to the anchor part.

In another embodiment, a method for implanting a device in a blood vessel is provided. The apparatus comprises an anchor portion having a proximal end, a distal end, and an anchor body connecting the proximal end and the distal end, wherein the anchor body is configured to exert a radial force. An anchor part, a cap part located on the proximal side of the anchor part, a plurality of projecting elements disposed at a proximal end of the cap part, and a proximal part of the anchor part A connection module located on a side and on a distal side of the cap portion, the connection module having a module body, and connecting the module body to the cap portion At least one compressible cap connector and at least one compressible anchor connector connecting the module body to a proximal end of the anchor portion. The method includes locating the anchor portion of the device in a side branch vessel, the strut of the anchor body exerting a radial force on the side branch vessel, and the cap portion between the side branch vessel and the main branch vessel. Placing at a bifurcation point; exerting a force on the cap portion to push the cap portion toward the anchor portion by a linear distance; and the anchor portion substantially within the side branch vessel Absorbing a part of the linear distance with the connecting module so as to keep the position of

In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be appreciated by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, and structures may not be described in detail to avoid obscuring the present invention.

Embodiments of the present invention selectively protect at least a portion of a predetermined region, for example, an inlet region of a branched blood vessel, and / or a drug on at least a portion of the predetermined region, as described below. Intraluminal devices configured to be distributed substantially uniformly may be included.

It is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or drawings. The invention may be practiced or carried out in other embodiments or in various ways. It is also to be understood that the expressions and terms used in this application are for purposes of explanation and should not be considered as limiting.

Furthermore, it should be understood that certain features of the invention described in the context of separate embodiments for clarity may be provided in combination in a single embodiment. On the contrary, for the sake of brevity, the various features of the invention described in the context of a single embodiment may be provided separately or in any suitable subcombination.

Next, with reference to FIG. 1, a bifurcated blood vessel 202 including a main blood vessel 204 and a side branch blood vessel 206 extending from the main blood vessel 204 will be schematically described. The bifurcated blood vessel 202 may include a target tissue, eg, a plaque layer 219 that includes the affected area (“lesion”) and blocks the flow of blood from the affected area of the blood vessel. The lesion may be located along at least a portion of the main vessel 204, the side branch vessel 206 and / or the entrance region 208 between the side branch vessel 206 and the main vessel 204. For example, the type 4a bifurcation lesion 218 may be located in the main blood vessel 204 proximal to the entrance region 208.

Next, referring to FIG. 2A, a schematic diagram of the intraluminal device 100 and a schematic diagram of the connection module 106 of the intraluminal device 100 will be described. The intraluminal device 100 includes a cap portion 102, an anchor portion 104, and a connection module 106. Anchor portion 104 is configured to fit into side branch blood vessel 206. The cap portion 102 is configured to selectively protect at least a portion of the inlet portion region 208. The connection module 106 flexibly connects the anchor portion 104 and the cap portion 102 so that various angles can be engaged between each of the three portions, as will be described in detail later. Specifically, the intraluminal device 100 can provide a large angular shift at short axial distances due to its design features.

The connection module 106 includes a cap connector 132 that connects the main body 130 of the connection module 106 and the cap portion 102, and an anchor connector 134 that connects the main body 130 of the anchor portion 104. In some embodiments, the cap connector 132 includes two connectors that are separated from each other by 180 degrees about the body 130, and the anchor connector 134 is separated from each other by 180 degrees about the body 130. Includes two connectors located approximately 90 degrees from the cap connector 132. Accordingly, the cap connector 132 can be bent back and forth or horizontally in one direction, and the anchor connector 134 can be bent back and forth or horizontally in another direction that is perpendicular to the bending direction of the cap connector 132, and the connection module. 106 provides overall multi-directional flexibility. In some embodiments, the bending of the cap connector 132 and anchor connector 134 is variable so that either or both of the cap connector 132 and anchor connector 134 can be bent in multiple directions.

In some embodiments, the cap connector 132 and the anchor connector 134 are pre-shaped at a particular angle and therefore require less force for bending at a particular angle. In some embodiments, only one cap connector 132 and / or one anchor connector 134 is used. The body 130 can be of various designs and shapes, but should be designed so that it can be creased to a smaller diameter and expandable by placement of the intraluminal device 100. Examples of such designs are described in more detail below.

Yet another function of the coupling module 106 is to provide a spring-like mechanism for correcting the axial, ie, vertical, position adjustment of the cap portion 102 within the blood vessel. Thus, when a force is applied to the cap portion 102 and the cap portion 102 is moved along the longitudinal axis of the device 100 in the E direction, ie, relative to the anchor portion 304 shown in FIG. It is absorbed by the connection module 106 and is not transmitted to the anchor unit 104. This “energy absorption” or linear position adjustment function facilitates placement of the device 100, as will be described in detail below. Such force or linear movement is absorbed by the operation of the body 130, cap connector 132, anchor connector 134 either individually or in combination with each other.

The intraluminal device 100, for example, to prevent the plaque layer 219 or a portion thereof from moving to the side branch vessel 206 due to a snow removal effect that can occur by applying an angioplasty device, as described below. In addition, the inlet region 208 and / or the side branch vessel 206 may be protected by selectively covering at least part of the inner wall of the inlet region 208.

In accordance with exemplary embodiments of the present invention, the intraluminal device 100 is generally elastic, super-elastic, in-vivo stable and / or “shape memory” material, that is, to take the originally shaped desired shape. For example, it may be formed of a material that can be formed into a desired shape at an early stage so that it is deformed by compression or the like during an initial treatment performed at a relatively high temperature. Intraluminal device 100 may be formed of a nickel and titanium alloy ("Nitinol") wire that has both superelastic and shape memory properties. The wire may have a diameter of 30 to 300 micrometers. In other embodiments, a biocompatible inelastic material, such as stainless steel, may be used.

In some embodiments, intraluminal device 100 is formed from a wire. In other embodiments, intraluminal device 100 is cut from a single tube. The intraluminal device 100 may be formed from a single piece of material or may be assembled from multiple pieces. In an alternative embodiment, the cap portion 102 may be a different material than the anchor portion 104. The cap portion 102 may be formed from any compliant material known to those skilled in the art, such as, for example, a polymer material. Further, the cap portion 102 may be formed from a non-compliant material.

According to an exemplary embodiment of the present invention, at least a portion of intraluminal device 100 is coated with a desired drug layer or material having desired properties to carry the desired drug and then apply and / or disperse. Also good. The anchor portion 104 and / or cap portion 102 may be coated with a controlled release polymer and / or drug as known in the art to reduce the likelihood of undesirable side effects such as, for example, restenosis. Good. Restenosis can occur as a result of a percutaneous procedure performed on a branched vessel 202, including, for example, inserting an angioplasty device into the branched vessel 202.

With reference now to FIG. 3, a perspective view of an intraluminal device 100 in accordance with an exemplary embodiment of the present invention will be described. The intraluminal device 100 includes an anchor unit 104, a cap unit 102, and a connection module 106 that connects the anchor unit 104 and the cap unit 102.

According to exemplary embodiments of the present invention, the anchor portion 104 may have a generally tubular shape, for example, a spring-like structure that is annularly symmetric about the central axis 103. In other embodiments, the anchor portion 104 has a geometric strut configuration, as described in detail below. In some embodiments, the anchor portion 104 has a generally conical structure and its distal portion has a smaller diameter than the proximal portion. The anchor unit 104 is configured to hold the intraluminal device 100 at a predetermined position in the blood vessel, and prevents the device from moving. The outer diameter of the anchor portion 104 may correspond to the inner diameter of the side branch blood vessel 206, that is, may be almost equal or slightly larger. According to some exemplary embodiments of the present invention, the outer diameter of the anchor portion 104 may be substantially constant along the central axis 103. According to other embodiments, for example, to improve positioning and / or to “fix” the anchor portion 104 to the side branch 206 and / or to facilitate insertion of the intraluminal device 100 into the side branch. In addition, the outer diameter of the anchor portion 104 may vary along the central axis 103. For example, the anchor portion 104 may have a generally conical shape, that is, the outer diameter of the anchor portion 104 may monotonously increase or decrease along the central axis 103.

According to an exemplary embodiment of the present invention, the cap portion 102 includes a plurality of protruding elements 109 extending in the proximal direction. In the exemplary embodiment, the plurality of protruding elements 109 are configured to extend in or in the inlet region 208. The number of protruding elements 109 is selected based on the particular anatomy in which the intraluminal device 100 is placed. Depending on the placement of the intraluminal device 100, the plurality of protruding elements 109 extend outward, form a trumpet shape, and are often not adequately protected due to known intraluminal device configurations. Protect range.

The coupling module 106 provides additional flexibility to the intraluminal device 100 by providing a configuration that allows angular shifting and axial adjustment, as described in more detail below.

With reference now to FIG. 4, an intraluminal device 300 in a top view illustrating a geometric configuration and pattern according to an exemplary embodiment of the present invention will be described. The anchor portion 304 has an anchor portion proximal end 303 and an anchor portion distal end 305 that is at least partially connected to other portions of the intraluminal device 300, as described below. The Anchor portion 304 is comprised of struts or support elements 308 and is interconnected to provide support within the side branch vessel 206. In some embodiments, the support elements 308 form a uniform or repeating cell pattern, such as a repeating diamond shape, hexagonal shape, or other pattern. In alternative embodiments, the support elements 308 form a non-uniform pattern having various pattern dimensions and / or post features. In one embodiment, the support elements 308 are comprised of a series of interconnected columns, such as columns 310-313 in FIG.

It will be readily apparent that the number of columns 310-313 may vary, and that the number of columns shown and described in this application for this embodiment is for illustration purposes only. Each column 310-313 has a sinusoidal pattern with vertices 315 and valleys 316, the vertices 315 being raised elements in a direction opposite the anchor distal end 305, and the valleys 316 are near the anchors. It is defined as an element that protrudes in a direction opposite to the distal end 303. Adjacent columns are 180 degrees out of phase in the sine wave pattern such that the apex 315 of a certain column, eg, column 310, matches the valley 316 of the adjacent column, eg, column 311. This configuration can be applied repeatedly to additional columns so that any desired number of columns can be included. Columns 310-313 are connected to each other in a contact region 318 between a column apex 315 and an adjacent column valley 316. In alternative embodiments, adjacent columns are out of phase with each other by the same phase or other degrees. The length of the anchor portion 304 may be in the range of 4 to 20 mm in the unexpanded state, and the diameter may be in the range of 2 to 6 mm in the fully expanded state.

The cap portion 302 includes, for example, a plurality of protruding elements 309 configured in a sinusoidal pattern having a cap apex 320 and a cap trough 322, the cap apex 320 being an element facing the distal side 321 of the cap portion 302. The cap valley 322 is defined as the element that faces the proximal side 319 of the cap portion 302. Cap apex 320 and cap trough 322 are such that upper section 325 is alternately connected to lower section 326 on proximal side 319 forming cap trough 322 and distal side 321 forming cap apex 320. Connected by an upper section 325 and a lower section 326 that are angled repeatedly in one direction and in the opposite direction. In alternative embodiments, the protruding elements 309 are configured in other patterns, including non-angled upper and lower sections, circular, square or other suitable configurations. In the exemplary embodiment, the plurality of projecting elements 309 are configured to be larger than the individual column support elements 308 of the anchor portion 304 and extend in or in the inlet region 208. Some protruding elements 309 further include a tip portion 324 at its proximal end. In one embodiment, only a few protruding elements 309 (eg, every other) include tip portions 324. In other embodiments, all protruding elements 309 include a tip portion 324. The tip portion 324 provides an additional surface area for delivering a drug and is suitable for placing a marker thereon. In some embodiments, the plurality of protruding elements 309 is in the range of 1 to 6 mm in length. After molding, the diameter defined by cap apex 320 may range from 3 to 10 mm.

The connection module 306 is provided between the anchor portion 304 and the cap portion 302 and includes a main body 330, a cap connector 332, and an anchor connector 334. The purpose of the coupling module 306 is to provide a minimal radius of curvature between the anchor portion 304 and the cap portion 302 so that the intraluminal device 300 can be bent at a variety of different angles without significant additional rotation. That is. Yet another object of the coupling module 306 is to provide a spring-like mechanism for correcting the axial adjustment of the cap 302 within the blood vessel. Thus, the portion to which force is applied, for example, the cap portion 302 that moves the cap portion 302 toward the anchor portion 304 in the longitudinal direction of the device 100 is absorbed by the coupling module 306, and vertical movement or movement is applied to the anchor portion 304. Not transmitted. As will be described in more detail below, this “energy absorption” or linear position correction operation facilitates placement of the apparatus 300. Energy is absorbed by manipulating the body 330, cap connector 332 and anchor connector 334 individually or in combination with each other.

The body 330 may have a geometric pattern or configuration similar to the anchor portion 304, or may have a different pattern or configuration. The length of the body 330 is minimized to obtain the maximum bending capacity. For example, the length of the main body 330 may be in the range of 0.5 to 4 mm. In one embodiment, the body 330 includes a row of connecting struts having a sinusoidal pattern with vertices 336 and valleys 338, with the vertices 336 in a direction opposite the anchor portion 304, as shown in FIG. As a raised element, the valley 338 is defined as an element that rises in a direction opposite to the cap portion 302.

In the embodiment shown in FIG. 4, the anchor connector 334 is disposed between the apex 336 of the coupling module 306 and the trough 316 of the anchor portion 304. Further, the cap connector 332 is disposed between the valley portion 338 of the connection module 306 and the vertex 320 of the cap portion 302. In the exemplary embodiment, anchor connectors 334 are spaced apart from each other to provide a high degree of flexibility between coupling module 306 and anchor portion 304, and cap connector 332 is between coupling module 306 and cap portion 302. Spaced apart from each other to provide a high degree of flexibility. For example, the anchor connector 334 may arrange every five or six vertices 336 of the coupling module 306 such that the anchor connector 334 and the cap connector 336 are alternately positioned along the body 330. May arrange every five or six valleys 338 of the coupling module 306. In some embodiments, the struts of the connection module 306 body 330 are shorter than the struts of the cap portion 302 protruding element 309. In some embodiments, anchor connector 334 and cap connector 336 are vertical connectors. In other embodiments, anchor connector 334 and cap connector 336 are curved connectors, helical connectors, or S-type connectors, as shown in FIG. In some embodiments, anchor connector 334 and cap connector 336 are preformed. In some embodiments, anchor connector 334 does not have the same configuration as cap connector 336.

The linear correction function of the device 300 operates by the functions of the cap connector 332, the anchor connector 334, and the main body 330. As shown in FIG. 4, the cap connector 332 and the anchor connector 334 each include a connector space A. When a force is applied to the cap portion 302, the space A is closed, ie, compressed, and the cap connector 332 or anchor connector 334 portion facilitates each other to accommodate movement of the cap portion 302. The full line absorption or linear correction component provided by cap connector 332 and anchor connector 334 is therefore 2 × A.

In addition, linear correction is provided by the body 330. When the force applied to the cap portion 302 or its linear movement is transmitted to the main body 330 via the cap connector 332, the main body 330 bends in a manner similar to that of a vertical beam.

When no force is applied, the body 330 has a vertical neutral circumferential axis or line 110 as shown in FIG. 11A. In response to the force applied to the body 330, each of the cap connector 332 and anchor connector 334 is compressed, and the body 330 obtains a curved neutral circumferential axis or line 110 ′, as shown in FIG. 11B. The vertex-to-vertex value Δ of the curved neutral circumferential axis or line 110 ′ as shown in FIG. 11B is the linear displacement portion absorbed by the body 330. It should be noted that the drawings of FIGS. 11A and 11B are intended for illustrative purposes only and are not intended to limit the invention. The display is not full scale, and the amount of bending is exaggerated for ease of explanation.

Therefore, the total line absorption value L can be expressed as L = 2 × A + Δ. In an exemplary embodiment, L is in the range of 1 to 2 mm.

Of course, those skilled in the art will appreciate that there is an upper limit on the linear movement or displacement of the cap portion 302 that can be absorbed by the coupling module 306.

It will be readily apparent that different numbers of connectors, as well as different configurations of struts, connectors, protruding elements, and patterns associated therewith, may be varied and all such possibilities are within the scope of the present invention. . It will also be apparent that the figures shown in this application show the structure of the intraluminal device 300 prior to molding. The intraluminal device 300 may then be shaped according to known techniques so that the plurality of protruding elements 309 bulge outwardly to form a substantially trumpet-like configuration. The trumpet shape formed by molding the intraluminal device 300 may have a bend radius in the range of 0.5 to 10 mm and a bend angle in the range of 90 to 180 degrees. Further, the shape and spacing of the main body 330, the cap connector 332, and the anchor connector 334 can be adjusted to modify the total line absorption value L.

Referring now to FIG. 5, an intraluminal device 400 in a top view illustrating a geometric configuration and pattern according to an exemplary embodiment of the present invention will be described. The anchor portion 404 has an anchor portion proximal end 403 and an anchor portion distal end 405, and the anchor portion proximal end 403 is connected to other portions of the intraluminal device 400, as described below. Anchor portion 404 is comprised of struts or support elements 408 interconnected to provide support within the side branch vessel 206. In some embodiments, the support elements 408 form a uniform or repeating cell pattern, such as a repeating diamond shape, hexagonal shape, or other pattern. In alternative embodiments, the support elements 408 form a non-uniform pattern having various pattern dimensions and / or post features. In one embodiment, support elements 408 are configured as a series of interconnected columns, for example, columns 410-413, as shown in FIG.

It will be readily apparent that the number of columns 410-413 may vary and that the number of columns shown and described herein for this embodiment is intended for illustrative purposes only. Each column 410-413 has a sinusoidal pattern with vertices 415 and valleys 416, where the vertices 415 are raised in the direction opposite the anchor distal end 405, and the valleys 416 are near the anchors. It is defined as an element that bulges in a direction opposite to the distal end 403. Adjacent columns are 180 degrees out of phase in the sinusoidal pattern such that a column apex 415, eg, column 410, is adjacent to an adjacent column valley 416, eg, column 411. This configuration can be applied repeatedly to additional columns so that any desired number of columns can be included. Columns 410-413 are connected to each other in a contact area 418 between a column apex 415 and an adjacent column valley 416. In alternative embodiments, adjacent columns are out of phase with each other by the same phase or other degrees. The length of the anchor portion 404 may be in the range of 4 to 20 mm in the unexpanded state, and the diameter may be in the range of 2 to 6 mm in the fully expanded state.

The cap portion 402 includes a plurality of protruding elements 409 configured, for example, in a sinusoidal pattern having a cap apex 420 and a cap valley 422, where the cap apex 420 is an element facing the distal side 421 of the cap portion 402. The cap valley 422 is defined as the element that faces the proximal side 419 of the cap portion 402. Cap apex 420 and cap trough 422 are such that upper section 425 is alternately connected with lower section 426 on proximal side 419 forming cap trough 422 and distal side 421 forming cap apex 420. Connected by an upper section 425 and a lower section 426 that are angled repeatedly in one direction and in the opposite direction. In alternative embodiments, the projecting elements 409 are configured in other patterns, including non-angled upper and lower sections, circular, square or other suitable configurations. In the exemplary embodiment, the plurality of protruding elements 409 are configured to extend in or in the inlet region 208 longer than the individual column support elements 408 of the anchor portion 404. Some protruding elements 409 further include a tip portion 424 at the proximal end thereof. In one embodiment, only a few protruding elements 409 (eg, every other one) include a tip portion 424. In other embodiments, all protruding elements 409 include a tip portion 424. The tip portion 424 provides an additional surface area for delivering a drug and is suitable for placing a marker thereon. In some embodiments, the plurality of protruding elements 409 are in the range of 1 to 6 mm in length. After molding, the diameter defined by the cap apex 420 may range from 3 to 10 mm.

The connection module 406 is provided between the anchor portion 404 and the cap portion 402 and includes a main body 430, a cap connector 432, and an anchor connector 434. The purpose of the coupling module 406 is to provide a minimal radius of curvature between the anchor portion 404 and the cap portion 402 so that the intraluminal device 400 can be bent at a variety of different angles without significant additional rotation. That is. Yet another object of the coupling module 406 is to provide a spring-like mechanism for correcting the axial adjustment of the cap portion 402 within the blood vessel. Thus, the portion to which force is applied, for example, the cap portion 402 that moves the cap portion 402 toward the anchor portion 404 in the longitudinal direction of the device 400 is absorbed by the coupling module 406, and the vertical motion or movement is Not transmitted. As will be described in more detail below, this “energy absorption” or linear position correction operation facilitates placement of the device 400. The energy is absorbed by the operation of the main body 430 and the cap connector 432m anchor connector 434 individually or in combination with each other.

The body 430 may have a geometric pattern or configuration similar to the anchor portion 404, or may have a different pattern or configuration. The length of the body 430 is minimized to obtain the maximum bending capacity. For example, the length of the main body 430 may be in the range of 0.5 to 4 mm. In one embodiment, the body 430 includes an array of interconnecting struts having a sinusoidal pattern with vertices 436 and valleys 438, with the vertices 436 in a direction opposite the anchor portion 404, as shown in FIG. As a raised element, the valley part 438 is defined as an element that rises in a direction opposite to the cap part 402. In this embodiment, adjacent columns 450-452 are connected to each other by an occlusal body connector 453. The occlusal body connector 453 is configured to connect with the apex 436 of the adjacent occlusal body column. In this configuration, each vertex 436 of columns 450-452 and each valley 438 of columns 450-452 are substantially aligned such that overlap of adjacent portions of occlusal body 430 is minimized in response to bending. Is done. In an alternative embodiment, the occlusal body connector 453 is configured to connect with a valley 438 of adjacent occlusal body columns. In the exemplary embodiment, the occlusal body connectors 453 are spaced apart from each other to provide a high degree of flexibility between the occlusal body columns 450-452. For example, the occlusal body connector 453 may be arranged at every 4 or 5 vertices in individual occlusion body columns so as to improve flexibility. The occlusal body connector 453 may be a vertical connector as shown in FIG. 5, or a curved connector, a helical connector, an S-type connector, or other suitable connector.

In the embodiment shown in FIG. 5, the anchor connector 434 is disposed between the apex 436 of the distal column 452 of the coupling module 406 and the apex 415 of the anchor portion 404. Further, the cap connector 436 is disposed between the apex 436 of the proximal column 450 of the coupling module 406 and the apex 420 of the cap portion 402. In the exemplary embodiment, anchor connectors 434 are spaced apart from each other to provide a high degree of flexibility between coupling module 406 and anchor portion 404, and cap connector 432 is between coupling module 406 and cap portion 402. In order to provide a high degree of flexibility. For example, the anchor connector 434 is arranged with every five or six vertices 436 in the distal column 452 of the coupling module 406 such that the anchor connector 434 and the cap connector 432 are alternately positioned along the body 430. Alternatively, the cap connector 432 may have every fifth or sixth apex 436 of the proximal column 450 of the coupling module 406. In some embodiments, the support module 406 body 430 post is shorter than the cap 402 protruding element 409 support post. In some embodiments, anchor connector 434 and cap connector 432 are vertical connectors as shown in FIG. In other embodiments, anchor connector 434 and cap connector 432 are curved connectors, helical connectors, or S-type connectors. In some embodiments, anchor connector 434 and cap connector 432 are preformed. In some embodiments, the anchor connector 434 does not have the same configuration as the cap connector 432.

The linear correction function of the device 400 works mainly by the function of the main body 430. As shown in FIG. 5, the cap connector 432 and the anchor connector 434 are each vertical connectors, and thus the connector space A = 0 and does not provide a linear correction function. When a force or linear movement is transmitted to the body 430, the body 430 operates similarly to the method described with reference to FIGS. 11A and 11B.

Thus, the total line absorption value L can be expressed as L = 2 × A + Δ, where A = 0 and L = Δ. In the exemplary embodiment of FIG. 5, L is in the range of 1 to 1.5 mm.

It will be readily apparent that different numbers of connectors, as well as different configurations of struts, connectors, protruding elements, and patterns related thereto may be varied and all such possibilities are within the scope of the present invention. Let's go. It will also be apparent that the figures shown in this application show the structure of the intracavity device 400 prior to molding. The intraluminal device 400 may then be shaped according to known techniques so that the plurality of protruding elements 409 bulge outwardly to form a substantially trumpet-like configuration. The trumpet shape formed by molding the intraluminal device 400 may have a bend radius in the range of 0.5 to 10 mm and a bend angle in the range of 90 to 180 degrees. Further, the shape and spacing of the main body 430, the cap connector 432, and the anchor connector 434 can be adjusted to modify the total line absorption value L.

Referring now to FIG. 6, an intraluminal device 500 in a plan view will be described that shows the geometry and pattern according to an alternative embodiment of the present invention. The anchor portion 504 has an anchor portion proximal end 503 and an anchor portion distal end 505, and the anchor portion proximal end 503 is connected to other parts of the intraluminal device 500, as will be described later. The anchor portion 504 includes a first anchor portion 527, a second anchor portion 529, and an anchor connection portion 531 that connects the first and second anchor portions 527 and 529. First anchor portion 527 and second anchor portion 529 are comprised of struts or support elements 508 interconnected to provide support within the side branch vessel 206. Anchor connection 531 includes at least one column of struts that are flexibly connected to each of first and second anchor portions 527 and 529, thereby providing additional flexibility to anchor portion 504. This type of design may be beneficial, for example, in vascular branches having curved or serpentine shapes. Furthermore, it is possible to use only the most distal portion (second anchor portion 529 in FIG. 6) for initial fixation during the procedure and the rest of the anchor portion 504 to be used for subsequent fixation. The anchor connection portion 531 is connected to the first and second anchor portions 527 and 529 via the anchor portion connector 560. In the exemplary embodiment, anchor portion connectors 560 are spaced apart from each other to provide a high degree of flexibility between first and second anchor portions 527 and 529. For example, the anchor portion connector 560 may be arranged at every fourth or fifth apex of the distal column 515 of the first anchor portion 527 so as to improve flexibility. The anchor connector 560 may be a vertical connector as shown in FIG. 6, or a helix or S connector, or other suitable connector.

In some embodiments, the support elements 508 form a uniform or repeating cell pattern, such as a repeating diamond shape, hexagonal shape, or other pattern. In alternative embodiments, the support elements 508 form a non-uniform pattern having various pattern dimensions and / or post features. In one embodiment, the support elements 508 of the first and second anchor portions 527 and 529 are configured as two interconnected columns 510-512, 513-515.

The number and location of columns 510-515 may vary, and it is readily apparent that the number and location of columns shown and described in this application for this embodiment is intended for illustrative purposes only. Let's go. Each column 510-515 has, for example, a sinusoidal pattern with vertices 517 and valleys 516, where the vertices 517 are raised in a direction opposite the anchor distal end 505 and the valleys 516 are anchors. Defined as an element that bulges in a direction opposite the proximal end 503. Adjacent columns are 180 degrees out of phase in the sine wave pattern such that the apex 517 of a certain column, eg, column 510, is adjacent to the adjacent column, eg, valley 516 of column 511. This configuration can be applied repeatedly to additional columns so that any desired number of columns can be included. Columns 510-512 and 513-515 are connected to each other at a contact region 518 between a column apex 515 and an adjacent column valley 516. In alternative embodiments, adjacent columns are out of phase with each other by the same phase or other degrees. The length of the anchor portion 504 may be in the range of 4 to 20 mm in the unexpanded state, and the diameter may be in the range of 2 to 6 mm in the fully expanded state.

The cap portion 502 includes a plurality of protruding elements 509 configured in a sinusoidal pattern having a cap apex 520 and a cap valley 522, the cap apex 520 being a cap facing the distal side 521 of the cap portion 502. The valley 522 is defined as the element that faces the proximal side 519 of the cap 502. Cap apex 520 and cap trough 522 are such that upper section 525 is alternately connected with lower section 526 at proximal side 519 forming cap trough 522 and distal side 521 forming cap apex 520. Connected by an upper section 525 and a lower section 526 that are angled repeatedly in one direction and in the opposite direction. In alternative embodiments, the protruding elements 509 are configured in other patterns, including non-angled upper and lower sections, circular, square or other suitable configurations. In the exemplary embodiment, the plurality of protruding elements 509 are configured to extend larger than or in the direction of the inlet region 208 than the individual column support elements 508 of the anchor portion 504. Some protruding elements 509 further include a tip portion 524 at its proximal end. In one embodiment, only a few protruding elements 509 (eg, every other) include tip portions 524. In other embodiments, all protruding elements 509 include a tip portion 524. The tip portion 524 provides an additional surface area for delivering the drug and is suitable for placing a marker thereon. In some embodiments, the plurality of protruding elements 509 are in the range of 1 to 6 mm in length. After molding, the diameter defined by cap apex 520 may range from 3 to 10 mm.

The connection module 506 is provided between the anchor portion 504 and the cap portion 502 and includes a main body 530, a cap connector 532, and an anchor connector 534. The purpose of the coupling module 506 is to provide a minimal radius of curvature between the anchor portion 504 and the cap portion 502 so that the intraluminal device 500 can be bent at a variety of different angles without significant additional rotation. That is. Yet another object of the coupling module 506 is to provide a spring-like mechanism for correcting the axial adjustment of the cap 502 within the blood vessel. Accordingly, the portion to which force is applied, for example, the cap portion 502 that moves the cap portion 502 toward the anchor portion 504 in the longitudinal direction of the device 500 is absorbed by the connection module 506, and the vertical movement or movement is applied to the anchor portion 504. Not transmitted. As will be described in more detail below, this “energy absorption” or linear position correction operation facilitates placement of the device 500. Energy is absorbed by manipulating body 530, cap connector 532, anchor connector 534 separately or in combination / sub-coupled to each other.

The body 530 may have a geometric pattern or configuration similar to the anchor portion 504, or may have a different pattern or configuration. The length of the body 530 is minimized to obtain the maximum bending capacity. For example, the length of the main body 530 may be in the range of 0.5 to 4 mm. In one embodiment, the body 530 includes a string of interconnecting struts having a sinusoidal pattern with vertices 536 and valleys 538, with the vertices 536 in a direction opposite the anchor portion 504, as shown in FIG. As a raised element, the valley part 538 is defined as an element that rises in a direction opposite to the cap part 502. In this embodiment, adjacent columns 550-552 are connected to each other by an occlusal body connector 553. The occlusal body connector 553 is configured to connect to adjacent occlusal body column vertices 536. In an alternative embodiment, the occlusal body connector 553 is configured to connect with adjacent occlusal body column troughs 538. In the exemplary embodiment, the occlusal body connectors 553 are spaced apart from each other to provide a high degree of flexibility between the occlusal body columns 550-552. For example, the occlusal body connector 553 may be arranged at every 4 or 5 vertices in individual occlusion body columns so as to improve flexibility. The occlusal body connector 553 may be a vertical connector as shown in FIG. 6, or a curved connector, a helical connector, an S-type connector, or other suitable connector.

In the embodiment shown in FIG. 6, the anchor connector 534 is disposed between the apex 536 of the distal column 552 of the coupling module 506 and the apex 517 of the anchor portion 504. Further, the cap connector 532 is disposed between the apex 536 of the proximal column 550 of the coupling module 506 and the apex 520 of the cap portion 502. In the exemplary embodiment, anchor connectors 534 are spaced from one another to provide a high degree of flexibility between coupling module 506 and anchor portion 504, and cap connector 532 is between coupling module 506 and cap portion 502. Spaced apart from each other to provide a high degree of flexibility. For example, anchor connector 534 arranges every fifth or sixth apex 536 of distal column 552 of coupling module 506 so that anchor connector 534 and cap connector 536 are arranged alternately along body 530. Alternatively, the cap connector 532 may have every fifth or sixth apex 536 of the proximal column 550 of the coupling module 506. In some embodiments, the post of the connection module 506 body 530 is shorter than the post of the protruding element 509 of the cap portion 502. In some embodiments, anchor connector 534 and cap connector 536 are vertical connectors as shown in FIG. In other embodiments, anchor connector 534 and cap connector 536 are curved connectors, helical connectors, or S-type connectors. In some embodiments, anchor connector 534 and cap connector 536 are preformed. In some embodiments, the anchor connector 534 does not have the same configuration as the cap connector 536.

The linear correction function of the device 500 works mainly by the function of the main body 530. As shown in FIG. 6, the cap connector 532 and the anchor connector 534 are each vertical connectors, and thus the connector space A = 0 and does not provide a linear correction function. However, when force or linear movement is transmitted to the body 530, the struts of the body 530 arranged in a sinusoidal manner act in a manner similar to that described with reference to FIGS. 11A and 11B.

Thus, the total line absorption value L can be expressed as L = 2 × A + Δ, where A = 0 and L = Δ. In the exemplary embodiment of apparatus 500, L is in the range of 1 to 1.5 mm.

It will be readily apparent that different numbers of connectors, as well as different configurations of struts, connectors, protruding elements, and patterns related thereto may be varied and all such possibilities are within the scope of the present invention. Let's go. It will also be apparent that the figures shown in this application show the structure of the intraluminal device 500 prior to molding. The intraluminal device 500 may then be shaped according to known techniques such that the plurality of protruding elements 509 bulge outward to form a substantially trumpet-like configuration. The trumpet shape formed by molding the intraluminal device 500 may have a bend radius in the range of 0.5 to 10 mm and a bend angle in the range of 90 to 180 degrees. Further, the shape and spacing of the body 530, cap connector 532, anchor connector 534 can be adjusted to modify the total line absorption value L.

The aforementioned intraluminal device design for various embodiments, including a coupling module disposed between the cap and the anchor portion, allows for different angles of occlusion between each of the three portions of the device, and the cap portion. Energy absorption or relaxation between the anchor portions becomes possible. This allows the use of intraluminal devices as disclosed herein at various angle branches with improved wall adhesion. Variations in flexibility may be achieved by shortening and / or extending the connection module and increasing or decreasing the strut width within the connection module.

Next, with reference to FIGS. 7A and 7B, an intraluminal device 600 according to another embodiment of the present invention will be described, respectively. The intraluminal device 600 includes an anchor unit 604, a cap unit 602, and a connection module 606 that connects the anchor unit 604 and the cap unit 602. Anchor portion 604 has an anchor portion proximal end 603 and an anchor portion distal end 605, as will be described below, anchor portion proximal end 603 is at least partially connected to other portions of intraluminal device 600. The Anchor portion 604 is comprised of struts or support elements 608 interconnected to provide support within the side branch vessel 206. In some embodiments, the support elements 608 form a uniform or repeating cell pattern, such as a repeating diamond shape, hexagonal shape, or other pattern. In alternative embodiments, the support elements 608 form a non-uniform pattern having various pattern dimensions and / or post features. In one embodiment, the support elements 608 are configured as a series of interconnected columns, for example, columns 610-613, as shown in FIG. 7B.

It will be readily apparent that the number of columns 610-613 may vary, and that the number of columns shown and described herein for this embodiment is intended for illustrative purposes only. Each column 610-613 has a sinusoidal pattern with vertices 615 and valleys 616, where the vertices 615 are raised in the direction opposite the anchor distal end 605 and the valleys 616 are near the anchors. It is defined as an element that bulges in a direction opposite to the distal end 603. Adjacent columns are 180 degrees out of phase in the sine wave pattern such that the apex 615 of a certain column, eg, column 610, coincides with the valley 616 of the adjacent column, eg, column 611. This configuration can be applied repeatedly to additional columns so that any desired number of columns can be included. The columns 610-613 are connected to each other in a contact area 618 between a column apex 615 and an adjacent column valley 616. In alternative embodiments, adjacent columns are out of phase with each other by the same phase or other degrees. The length of the anchor portion 604 may be in the range of 4 to 20 mm in the unexpanded state, and the diameter may be in the range of 2 to 6 mm in the fully expanded state.

The cap portion 602 includes a plurality of projecting elements 609 extending in a proximal direction, and the plurality of projecting elements 609 are configured to extend in or in the inlet region 208. The number of the plurality of protruding elements 609 is selected based on the specific anatomy in which the intraluminal device 600 is placed. Further, the length of each of the plurality of protruding elements 609 may be different from each other, thus providing an asymmetric cap portion 602. For example, the length of the plurality of protruding elements 609 may be different so that the angular end of the intraluminal device 600 can be formed. For example, the longest plurality of protruding elements 609 may be in the range of 4 to 10 mm in length, and the shortest plurality of protruding elements may be in the range of 1 to 5 mm in length. With these configurations, the entrance region 208 can be more protected at various angles of branching. In some embodiments, the length of the plurality of protruding elements is designed to optimally cover a branch in the range of 30 to 60 degrees, and the longest plurality of protruding elements is in the range of 6 to 10 mm in length. The shortest plurality of protruding elements is in the range of 3 to 5 mm in length. In other embodiments, the length of the plurality of protruding elements is designed to optimally cover a branch in the range of 10 to 45 degrees, with the longest plurality of protruding elements ranging in length from 6 to 12 mm. The shortest plurality of protruding elements is in the range of 1 to 5 mm in length. In other embodiments, the length of the plurality of protruding elements is designed to optimally cover the branches in the range of 60 to 90 degrees, with the longest plurality of protruding elements in the range of 4 to 10 mm in length. The shortest plurality of protruding elements is also in the range of 4 to 10 mm in length. It will also be apparent that the figures shown in this application show the structure of the intraluminal device 600 prior to molding. The intraluminal device 600 may then be shaped according to known techniques such that a plurality of protruding elements 609 bulge outwardly to form a substantially trumpet-like configuration. The trumpet shape formed by molding the intraluminal device 600 may have a bend radius in the range of 0.5 to 10 mm and a bend angle in the range of 90 to 180 degrees.

The connection module 606 is provided between the anchor portion 604 and the cap portion 602 and includes a main body 630, a cap connector 632, and an anchor connector 634. The purpose of the coupling module 606 is to provide a minimal radius of curvature between the anchor portion 604 and the cap portion 602 so that the intraluminal device 600 can be bent at a variety of different angles without significant additional rotation. That is. Yet another object of the coupling module 606 is to provide a spring-like mechanism for correcting the axial adjustment of the cap 602 within the blood vessel. Accordingly, the portion to which force is applied, for example, the cap portion 602 that moves the cap portion 602 in the longitudinal direction of the device 600 toward the anchor portion 604 is absorbed by the connection module 606, and the vertical movement or movement is applied to the anchor portion 604. Not transmitted. As will be described in more detail below, this “energy absorption” or linear position correction operation facilitates placement of the device 600. The energy is absorbed by the operation of the main body 630, the cap connector 632, and the anchor connector 634 individually or in combination with each other.

The body 630 may have a geometric pattern or configuration similar to the anchor portion 604, or may have a different pattern or configuration. The length of the body 630 is minimized to obtain the maximum bending capacity. For example, the length of the main body 630 may be in the range of 0.5 to 4 mm. In one embodiment, the body 630 includes a row of interconnected struts having a sinusoidal pattern with vertices 636 and troughs 638, with the vertices 636 facing away from the anchor portion 604, as shown in FIG. 7B. The valley portion 638 is defined as an element that protrudes in a direction opposite to the cap portion 602.

In the embodiment shown in FIG. 7B, the anchor connector 634 is disposed between the apex 636 of the coupling module 606 and the trough 616 of the anchor portion 604. Further, the cap connector 632 is disposed between the valley 638 of the connection module 606 and the apex 620 of the cap 602. In the exemplary embodiment, anchor connectors 634 are spaced apart from each other to provide a high degree of flexibility between coupling module 606 and anchor portion 604, and cap connector 632 is disposed between coupling module 606 and cap portion 602. In order to provide a high degree of flexibility. For example, the anchor connector 634 may arrange every five or six vertices 636 of the coupling module 606 such that the anchor connector 634 and the cap connector 632 are alternately positioned along the body 630. May arrange every five or six valleys 638 of the coupling module 606. In some embodiments, the struts of the connection module 606 body 630 are shorter than the struts of the cap portion 602 protruding element 609. In some embodiments, anchor connector 634 and cap connector 632 are vertical connectors. In other embodiments, anchor connector 634 and cap connector 632 are curved connectors, helical connectors, or S-type connectors, as shown in FIG. 7B. In some embodiments, anchor connector 634 and cap connector 632 are preformed. In some embodiments, anchor connector 634 does not have the same configuration as cap connector 632.

The linear correction function of the device 600 works by the functions of the cap connector 632, the anchor connector 634, and the main body 630. As shown in FIG. 7B, the cap connector 632 and the anchor connector 634 each include a connector space A. When force is applied to the cap portion 602, the space A is closed, ie, compressed, and the cap connector 632 or anchor connector 634 portion facilitates each other to accommodate movement of the cap portion 602. The portion of full line absorption provided by cap connector 634 and anchor connector 634 is therefore 2 × A.

In addition, linear correction is provided by the body 630. When the force applied to the body 630 or its linear movement is transmitted, the struts of the body 630 arranged in a sinusoid behave similarly to the method described with reference to FIGS. 11A and 11B.

Therefore, the total line absorption value L can be expressed as L = 2 × A + Δ. In an exemplary embodiment, L is in the range of 1 to 2 mm.

Of course, those skilled in the art will appreciate that there is an upper limit on the linear movement or displacement of the cap 602 that can be absorbed by the coupling module 606.

Referring now to FIGS. 8A-8H, a schematic diagram illustrating the steps of a method for placing an intraluminal device 100 according to an exemplary embodiment of the present invention will be described. Referring to FIG. 8A, a bifurcated vessel 202 is shown that includes a main vessel 204 and a side branch vessel 206 extending from the main vessel 204. Main branch guidewire 710 and side branch guidewire 712 are introduced into main vessel 204 and side branch vessel 206, respectively. As shown in FIG. 8B, a delivery system 714 for delivering and deploying the intraluminal device 100 is introduced over the side branch guidewire 712 and into the side branch vessel 206. Delivery system 714 may be any suitable delivery system, such as a sheath placement catheter, balloon placement catheter, or other system suitable for delivery of intraluminal device 100.

Next, with reference to FIG. 8C, a diagram of the delivery system 714 during placement of the intraluminal device 100 will be described. Referring to FIG. 8C, the distal portion 105 of the intraluminal device 100 is first released from the delivery device 714. However, it will be readily apparent that the proximal portion of intraluminal device 100 may be released first or the entire device substantially simultaneously. The intraluminal device 100 is shown after placement in FIG. 8D. A plurality of protruding elements 109 extend into the entrance region and provide a coating at difficult to reach locations. After deployment, the delivery system 714 is removed from the side branch vessel 206. In one embodiment, the plurality of protruding elements 109 are pre-shaped so that the shape of the inlet region can be maintained depending on the arrangement.

In one embodiment, the stent is introduced into the main vessel and is configured such that at least a portion of the plurality of protruding elements 109 are flat against the vessel wall. Thus, as shown in FIG. 8E, a main vessel stent delivery device 716 is introduced into the main vessel 204 for placement of the main vessel stent 718 therein. As shown in FIG. 8F, the balloon 720 is inflated so that the stent 718 is expanded. In an alternative embodiment, the stent 718 is a self-expanding stent and is deployed by methods other than balloon expansion, such as, for example, a removable sheath. In one embodiment, the stent 718 is a stent having a side hole that provides unhindered access to the side branch vessel 206. The placement of the stent 718 compresses at least a portion of the protruding element 109 against the vessel wall. After placement of the stent 718, the balloon 720 is deflated, as shown in FIG. 8G, and the stent delivery device 716 is removed from the blood vessel, as shown in FIG. 8H, leaving the intraluminal device 100 and the stent 718 in place. . Similar to the above, the coupling module 106 absorbs the forces of the balloon 720 and the stent 718 and prevents some of the forces from being transmitted to the anchor portion 104. Conveniently, a good contrast position is achieved around the inlet region, and the position of the device 100 in the side branch remains substantially unaffected.

In another embodiment, the intraluminal device 100 is a stand-alone device and does not require further stent placement, however, a balloon catheter is used to planarize at least some of the plurality of protruding elements 109. The In this embodiment, the method steps corresponding to FIGS. 8A-8D are performed first. Following the steps corresponding to FIG. 8D, a balloon catheter 1716 is inserted along the guide wire 710 into the main vessel, as shown in FIG. 10A. Next, as shown in FIG. 10B, the balloon 1720 is inflated. By expansion of the balloon 1720, at least a portion of the protruding element 109 is compressed against the vessel wall. Next, the balloon 1720 is deflated, as shown in FIG. 10C, and the balloon catheter 1716 is removed from the blood vessel, as shown in FIG. 10D, leaving the intraluminal device 100 in place. The balloon 1720 acts to flatten at least a part of the plurality of protruding elements 109 on the blood vessel wall around the entrance region. The connection module 106 absorbs the force of the balloon 1720 and prevents part of the force from being transmitted to the anchor portion 104. Conveniently, a good contrast position is achieved around the inlet region, and the position of the device 100 in the side branch remains substantially unaffected.

The above examples of methods corresponding to FIGS. 8A-8D and 10A-10D have been described for apparatus 100 for purposes of simplicity and are intended to limit the embodiments of the apparatus. Not. One skilled in the art will appreciate that the method is applicable to other device embodiments.

After placement of the intraluminal device 100 and stent 718 described above with reference to FIGS. 8A-8H, in some examples, to improve access to the side branch vessels, particularly when the stent 718 has no side holes. May be desirable. Next, with reference to FIGS. 9A-9D, a schematic diagram of the method steps for improving access to the side branch vessels will be described. First, as shown in FIG. 9A, a main blood vessel guide wire 710 and a side branch blood vessel guide wire 712 are introduced into the main blood vessel 204 and the side branch blood vessel 206, respectively. Next, as shown in FIG. 9B, the main vessel balloon catheter 800 and the vessel branch balloon catheter 810 are introduced onto the main vessel guide wire 710 and the side vessel guide wire 712. A main vessel balloon 812 is placed on the main vessel balloon catheter 800 and a branch vessel balloon 814 is placed on the vessel balloon catheter 810. As shown in FIG. 9C, the main vessel balloon 812 and the branch vessel balloon 814 are both inflated, preferably simultaneously, by a technique known as “Kissing Balloon”. Due to this expansion, the struts surrounding the inlet region 208 are deformed so as to improve the opening of the small holes. Main vessel balloon 812 and branch vessel balloon 814 are deflated, and main vessel balloon catheter 800 and branch vessel balloon catheter 810 are removed from the vessel, as shown in FIG. 9D, so that only intraluminal device 100 and stent 718 are in place. leave. Similarly, in this embodiment, the connection module 106 prevents some of the force applied by the balloon and / or stent from being transmitted to the anchor portion 104. Conveniently, a good contrast position is achieved around the inlet region, and the position of the device 100 in the side branch remains substantially unaffected.

Next, referring to FIGS. 12A and 12B, a schematic view of a branched blood vessel will be described. FIG. 12A shows a branched vessel 1102 that includes a main vessel 1104 and a side branch vessel 106 extending from the main vessel 1104. The angle of the branch 1105 is defined by the angle between the main vessel 1104 and the side branch vessel 106. Embodiments of the present invention are particularly beneficial for relatively small branch angles, such as angles in the range of 10 to 60 degrees. FIG. 12B shows a bifurcated blood vessel 1102 having a main blood vessel 1104 and two side branch vessels or arms 106 extending from the main blood vessel 1104. Such a branch is commonly known as a “Y” branch. The “Y” angle of the branch 1107 is defined as the angle between the two side branch vessels 106. Embodiments of the present invention are particularly beneficial for relatively small branch angles, such as angles in the range of 0 to 60 degrees. The bifurcated blood vessel 1102 may include a target tissue having a plaque layer 1119 that obstructs blood flow through the affected portion of the blood vessel, eg, the affected portion (“lesion”). The lesion may be located along at least a portion of the main vessel 1104, the side branch vessel 106 and / or the entrance region 1108 between the side branch vessel 106 and the main vessel 1104.

12C and 12D, a schematic illustration of the bifurcated vessel of FIGS. 12A and 12B having an intraluminal device 2200 located on the side branch 106 of the bifurcated vessel 1102 will now be described. The intraluminal device 1500 has an asymmetric proximal end 1501 for optimal protection of the side branch 106. In one embodiment, the main stent can be further placed within the main blood vessel 1104. In another embodiment, intraluminal device 1500 is a stand-alone device. The device of the present invention is configured to provide protection to the inlet region of the blood vessel while avoiding excessive deformation of the blood vessel.

13A-9C, a schematic diagram illustrating the shape of an intraluminal device 2200 according to various embodiments of the present invention will now be described. Intraluminal device 2200 is illustrated with respect to central axis 2203 and includes an anchor portion 2204 and a cap portion 2202. In one embodiment, the anchor portion 2204 has a relatively constant diameter d1 along the central axis 2203, as shown in FIG. 13A for the intraluminal device 2200. In another embodiment, as shown in FIG. 13B for intraluminal device 2200 ′, anchor portion 2204 ′ has a first diameter d1 at its distal end and a first diameter at its proximal end relative to central axis 2203. Has a second diameter d2. More specifically, the diameter of anchor portion 2204 ′ may increase proximally to form a substantially conical shape. In yet another embodiment, as shown in FIG. 13C for intraluminal device 2200 ", cap portion 2202" is configured in a trumpet-like shape and a portion of cap portion 2202 "adjacent to anchor portion 2204" Curved or molded outward with respect to the central axis 2203. The embodiment shown in FIG. 13C may include a substantially constant diameter along the anchor portion 2204 "as seen in the intraluminal device 2200 shown in FIG. 13A, or the intraluminal device 2200 shown in FIG. 13B. A variable diameter may be included along anchor portion 2204 ", as seen at '.

As a non-limiting example, referring now to FIG. 14A, a schematic diagram of an intraluminal device 600 disposed in a first angle bifurcation 2105, eg, a bifurcated blood vessel 2102 having 30 degrees, is shown in FIG. 14B. , A schematic diagram illustrating an intraluminal device 600 disposed in a bifurcated vessel having a second angle bifurcation 2105 ′, eg, 60 degrees, is described. As shown in the drawing, the longest plurality of protruding elements 609 are configured to cover the long hole 2111 of the small hole wall, and the shortest plurality of protruding elements 609 are configured to cover the short part 2113 of the small hole wall. Is done. As the bifurcation angle increases, the longest plurality of protruding elements 609 extend further into the main vessel 2106. Alternatively, the length of the plurality of protruding elements 609 can be designed for a particular branch angle or range of branch angles. Thus, for example, an apparatus configured for use with a branching angle of 10 to 45 degrees has a length in the range of 1 to 5 mm for the shortest plurality of protrusion elements 609 and for the longest plurality of protrusion elements 609. A first set of a plurality of protruding elements 609 having a length in the range of 4-10 mm may be included. A device configured for use with a branching angle of 30 to 60 degrees has a length in the range of 1 to 5 mm for the shortest plurality of projecting elements 609 and 3 to 8 mm for the longest plurality of projecting elements 609. A second set of projecting elements 609 having a range length may be included. It will be readily apparent that the length of the plurality of protruding elements 609 may be any length suitable for covering both sides of the stoma wall. Further, it will be apparent that any of the intraluminal devices described herein, or any other configuration of an intraluminal device having an anchor portion and a cap portion, may include similar protruding elements having variable lengths.

While some of the embodiments of the present invention described above may show an intraluminal device configured to cover a bifurcated coronary vessel and disperse a drug, an intraluminal device according to other embodiments of the present invention may be , Weakened, distorted or deformed and / or to disperse other substances in at least part of the lumen, artery or blood vessel, eg carotid artery or tracheal bifurcation, eg vascular system, bile duct system Those skilled in the art will appreciate that it may be configured to cover other branched lumens, arteries or blood vessels in the urogenital system, gastrointestinal system, respiratory system.

The medicinal coating includes, for example, one or more of paclitaxel, rapamycin, and heparin, but is not limited thereto.

While particular features of the invention have been shown and described, various modifications, substitutions, changes, and equivalents will occur to those skilled in the art. Accordingly, it is to be understood that the appended claims are intended to cover such modifications and changes as fall within the true spirit of the invention.

The foregoing and further advantages of the present invention will be better understood by reference to the following description taken in conjunction with the accompanying drawings.
FIG. 1 is a schematic view of a branched vessel including a main vessel and a side branch vessel. FIG. 2A is a schematic diagram of an intraluminal device according to an embodiment of the present invention. FIG. 2B is a schematic diagram of a connection module from the intraluminal device of FIG. 2A. FIG. 3 is a perspective view of an intraluminal device according to an exemplary embodiment of the present invention. FIG. 4 is a flattened view of the intraluminal device showing the geometry and pattern according to an exemplary embodiment of the present invention. FIG. 5 is a flattened view of an intraluminal device showing the geometry and pattern according to another embodiment of the present invention. FIG. 6 is a flattened view of an intraluminal device showing the geometry and pattern according to yet another embodiment of the present invention. FIG. 7A is a perspective view of an intraluminal device according to one embodiment of the present invention. FIG. 7B is a flattened view of the intraluminal device of FIG. 7A showing the geometry and pattern according to an embodiment of the present invention. 8A-8H are schematic diagrams illustrating steps of a method for placement of an intraluminal device according to an exemplary embodiment of the present invention. 9A-9D are schematic diagrams of a method for increasing side branch vascular access following the placement steps of FIGS. 8A-8H. 10A-10D are schematic diagrams illustrating the steps of a method of placing an apparatus according to one embodiment of the present invention. 11A and 11B are views of the body portion in a relaxed and curved configuration, respectively. 12A and 12B are schematic views of a branched vessel including a main vessel and a side branch vessel. 12C and 12D are schematic views of the bifurcated blood vessel of FIGS. 12A and 12B with an intraluminal device positioned in the side branch of the bifurcated blood vessel. 13A-13C are schematic diagrams illustrating various shapes of intraluminal devices according to embodiments of the present invention. 14A and 14B are schematic diagrams illustrating an intraluminal device positioned in a bifurcated blood vessel having a first angular bifurcation and a second angular bifurcation, respectively.

It will be understood that for simplicity and clarity of illustration, elements shown in the drawings have not necessarily been shown to scale or to scale. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity, or multiple physical components may be included in one of the functional blocks or elements. Further, for appropriateness, reference numerals may be repeated in the drawings to indicate corresponding or similar elements. Moreover, some blocks shown in the drawings may be combined into a single function.

Claims (36)

An anchor portion having a proximal end, a distal end, and an anchor body connecting the proximal end and the distal end, wherein the anchor body is a series of struts configured to exert a radial force An anchor part characterized by including,
A cap portion located on the proximal side of the anchor portion;
A plurality of projecting elements disposed at a proximal end of the cap portion;
A connection module located on the proximal side of the anchor part and on the distal side of the cap part, the connection module comprising a module body;
At least one compressible cap connector connecting the module body to the cap portion;
At least one compressible anchor connector connecting the module body to the proximal end of the anchor portion;
An intravascular graft device. The at least one compressible cap connector includes an S-type connector having a compressible space A, and the compressible space A is disposed between portions of the S-type connector. The device described. The at least one compressible anchor connector includes an S-shaped connector having a compressible space A, and the compressible space A is disposed between portions of the S-shaped connector. The apparatus in any one of thru | or 2. 4. A device according to any one of the preceding claims, wherein the body of the coupling module includes a plurality of columns of struts connected by coupling body connectors. An anchor portion having a proximal end, a distal end, and an anchor body connecting the proximal end and the distal end, wherein the anchor body is a series of struts configured to exert a radial force An anchor part characterized by including,
A cap portion located on the proximal side of the anchor portion;
It is a connecting means located between the anchor part and the cap part, and absorbs a part of the linear movement of the cap part toward the anchor part, and the absorbed part of the linear movement of the cap part is the And an intravascular graft device comprising coupling means for preventing transmission to the anchor portion. The connecting means includes
The module body;
Cap connecting means for connecting the module body to the cap portion;
Anchor connection means for connecting the module body to the anchor portion;
6. The apparatus of claim 5, comprising: 7. The apparatus of claim 6, wherein one or more of the module body, cap connection means, and anchor connection means absorb a portion of the linear movement of the cap portion. A method for implanting a device in a blood vessel, comprising:
The device is
An anchor portion having a proximal end, a distal end, and an anchor body connecting the proximal end and the distal end, wherein the anchor body is a series of struts configured to exert a radial force An anchor part characterized by including,
A cap portion located on the proximal side of the anchor portion;
A plurality of projecting elements disposed at a proximal end of the cap portion;
A connection module located on the proximal side of the anchor part and on the distal side of the cap part, the module comprising a module body;
At least one compressible cap connector connecting the module body to the cap portion;
At least one compressible anchor connector connecting the module body to the proximal end of the anchor portion;
The method
The anchor portion of the device is disposed in the side branch blood vessel, and the strut of the anchor body exerts a radial force on the side branch blood vessel, and the cap portion is disposed at the branch portion between the side branch blood vessel and the main branch blood vessel. Step to
Applying a force to the cap and pushing the cap toward the anchor by a linear distance;
Absorbing a portion of the linear distance with the connection module such that the anchor portion remains substantially in position within the side branch vessel;
A method for implanting a device in a blood vessel.
An anchor portion having a proximal end, a distal end, and an anchor body connecting the proximal end and the distal end, wherein the anchor body is configured to provide a radial force on the vessel wall. An anchor characterized by including a series of support columns;
A cap portion located on the proximal side of the anchor portion, the cap portion comprising a plurality of projecting elements extending into the invading region of the blood vessel;
An intravascular graft device comprising: a main body; at least one cap connector connecting the main body to the cap portion; and a coupling module having at least one anchor connector connecting the main body to the anchor portion;
The at least one cap connector is configured to bend in a first direction, and the at least one anchor connector is configured to bend in a second direction. The apparatus of claim 9, wherein the first direction is substantially perpendicular to the second direction. 11. An apparatus according to any one of claims 9 to 10, wherein at least one of the plurality of protruding elements is longer than at least one other of the plurality of protruding elements. The plurality of protruding elements are composed of an upper section and a lower section forming apexes and valleys, the body of the coupling module has a repeating pattern including apexes and valleys, and the at least one cap connector is The valley of the main body is connected to the apex of the cap portion, and the at least one anchor connector connects the apex of the main body to the trough of the anchor portion. A device according to the above. The device according to claim 9, wherein the plurality of projecting elements form a trumpet shape depending on the arrangement of the device. 14. The device according to claim 9, wherein the device is made of at least one of a superelastic material, a shape memory material, and an elastic material. 15. An apparatus according to any of claims 9 to 14, wherein the at least one cap connector includes two cap connectors separated from each other by approximately 180 degrees about the body of the coupling module. 16. Apparatus according to any of claims 9 to 15, wherein the at least one anchor connector comprises two anchor connectors separated from each other by about 180 degrees about the body of the coupling module. 17. A device according to any of claims 9 to 16, wherein at least a part of the device is coated with at least one layer of the desired drug. The apparatus according to claim 9, wherein at least one of the plurality of projecting elements is longer than the support column of the anchor portion. The device according to any one of claims 9 to 18, wherein the anchor portion comprises a plurality of anchor portions. An endovascular graft device,
An anchor portion having a proximal end, a distal end, and an anchor body connecting the proximal end and the distal end, the anchor body configured to provide a radial force on the vessel wall An anchor portion characterized by including a series of supported struts;
A cap portion located proximal to the anchor portion, the cap portion comprising a plurality of projecting elements extending into the ridge region of the blood vessel;
A connecting means connected between the anchor part and the cap part and bent in a first direction and a second direction;
An intravascular graft device. 21. The apparatus of claim 20, wherein the first direction is substantially perpendicular to the second direction. The plurality of protruding elements are composed of an upper section and a lower section forming apexes and valleys, and the body of the connection module has a repeating pattern including apexes and valleys, and the at least one cap connector is The valley of the main body is connected to the apex of the cap portion, and the at least one anchor connector connects the apex of the main body to the trough of the anchor portion. A device according to the above. 23. A device according to any one of claims 20 to 22, wherein the plurality of protruding elements form a trumpet shape depending on the arrangement of the device. 24. The device according to any one of claims 20 to 23, wherein the device comprises at least one of a superelastic material, a shape memory material, and an elastic material. The device according to any one of claims 20 to 24, wherein the connecting means includes two cap connectors connected to the cap portion and separated from each other by about 180 degrees around the device. 26. The device according to any one of claims 20 to 25, wherein the connecting means includes two anchor connectors connected to the anchor portion and separated from each other by about 180 degrees about the device. 27. A device according to any of claims 20 to 26, wherein at least a part of the device is coated with at least one layer of the desired drug. 28. A device according to any of claims 20 to 27, wherein at least one of the plurality of projecting elements is longer than a post of the anchor portion. 29. A device according to any of claims 20 to 28, wherein the anchor portion comprises a plurality of anchor portions. A method for providing protection to an inlet region of a bifurcated blood vessel, comprising:
An apparatus comprising an anchor portion, a cap portion located proximal to the anchor portion, the cap portion comprising a plurality of projecting elements, and a body, at least one cap connector connecting the body to the cap portion, Providing a coupling module including at least one anchor connector connected to the anchor portion;
Introducing the device into the side branch of the branched vessel;
Fixing the device to the side branch by at least partially releasing the anchor portion;
Releasing the cap and extending the plurality of projecting elements into the inlet region, the extension including providing an angular shift in accordance with the structure of the inlet region. A step characterized by:
A method for providing protection to a bifurcated blood vessel entrance region. Introducing a stent into the main branch of the branched blood vessel;
Compressing at least some of the plurality of protruding elements;
32. The method of claim 30, further comprising:
Introducing a main blood vessel balloon into the main blood vessel at the bifurcation point, and introducing a side branch blood vessel balloon into the side branch blood vessel at the bifurcation point;
Inflating the main vascular balloon and the side branch vascular balloon;
Deflating the main vessel balloon and the side branch vessel balloon;
Removing the main vessel balloon and the side branch vessel balloon from the main vessel and side branch vessel, respectively;
32. The method of claim 31, further comprising: The plurality of projecting elements are disposed circumferentially around a proximal opening of the cap portion;
21. A device according to any of claims 1, 9 and 20, characterized in that the shortest protruding element is arranged on a circumference substantially opposite the longest protruding element. A substantially cylindrical anchor having a proximal end and a distal end;
A cap portion having a proximal end and a distal end and coupled to the proximal end of the anchor portion;
A plurality of projecting elements disposed along a circumferential direction around a proximal opening at a proximal end of the cap portion, and a device for disposing at a branch point of a blood vessel,
At least one projecting element is longer than at least one other projecting element. The anchor body is substantially cylindrical with a substantially constant diameter along its length, or is cylindrical with a linear increase in diameter from the distal end to the proximal end, 35. The device of claim 34, wherein the device is either cylindrical and flared at the proximal end. 36. Apparatus according to any of claims 34 to 35, wherein the shortest protruding element is arranged on a circumference substantially opposite the longest protruding element.

Images