Expandable intraluminal endoprosthesis
20 claims: 7 independent, 13 dependent
- 1ほぼ均一な厚さの管壁を有した中空の管状体の前記管壁をレーザー切断、電気化学的エッチング、電気機械的放電あるいは他の適当な加工技術により切削加工して作られ、ほぼ螺旋状に連続したパターン構造を有した管状壁を持つ管状部材からなり、 前記管状壁を形成する前記パターン構造は、前記管状体の長手方向の軸に沿ってほぼ螺旋状に連続して繋がって延びる第1の波形のパターンと、螺旋状に連続して繋がって延びることにより隣接する前記第1の波形パターン同士を所定間隔をおいて一体に連結する複数の接続要素とを有して構成され、 前記接続要素が前記第1の波形パターンの延びる螺旋方向と交差する方向に繋がって延びるとともに第2の波形パターンを形成して上記交差する方向に螺旋状に延び、 前記管状部材は、体内の管腔内への前記部材の腔内配送を可能にする最初の非拡張状態における第一の直径を持ち、前記管状部材に内部から半径方向外方へ力を加えることによって、拡張及び変形して第二の直径を得ることが可能であり、この第二の直径は、前記管状部材に加えた前記力の大きさに応じて変化するため、前記管状部材を拡張し変形することによって体内の管腔を拡張することが可能であるように構成されており、 前記接続要素がそれぞれ、少なくとも前記非拡張状態において、前記管状壁内においてS字状に屈曲して形成されており、前記第二の直径までの前記管状部材の拡張および変形を容易にするように構成されていることを特徴とする拡張可能な管腔内部人工器官。
- 2前記パターン構造が前記第1の波形パターンを形成する連続的且つ螺旋状に延びた波形フィラメントからなり、前記管状壁を形成する前記波形フィラメントの第一の螺旋巻きが、前記接続要素によって、前記波形フィラメントの隣接する第二の螺旋巻きへ連結され、前記波形フィラメントが螺旋状に連結されたパターンからなる前記パターン構造が形成されることを特徴とする請求項1に記載の内部人工器官。
- 3前記波形フィラメントの隣接する 螺旋 巻きが、これらの 螺旋 巻き内の波形の数よりも少ない複数の 前記 接続要素によって相互に連結されていることを特徴とする請求項2に記載の内部人工器官。
- 4前記波形フィラメントを形成する複数の螺旋巻きにおける所定の螺旋巻きをこの所定の螺旋巻きの隣に位置する螺旋巻きに連結する第1の前記接続要素に対して、前記所定の螺旋巻きを前記隣の螺旋巻きと反対側に位置する螺旋巻きに連結する第2の前記接続要素を周方向にずらせることにより、前記接続要素が螺旋状に繋がって延びる追加の螺旋巻きパターンを形成して前記パターン構造が形成されることを特徴とする請求項2あるいは3に記載の内部人工器官。
- 5前記波形フィラメントにおける前記所定の螺旋巻きを前記隣に位置する螺旋巻きに連結する前記第1の接続要素に対して、前記所定の螺旋巻きを前記反対側に位置する螺旋巻きに連結する前記第2の接続要素を、前記波形フィラメントの波形ピッチのおよそ半波形ピッチの距離だけ周方向にずらせることを特徴とする請求項4に記載の内部人工器官。
- 6前記波形フィラメントにおける前記所定の螺旋巻きを前記隣に位置する螺旋巻きに連結する前記第1の接続要素に対して、前記所定の螺旋巻きを前記反対側に位置する螺旋巻きに連結する前記第2の接続要素を、前記波形フィラメントの波形ピッチのおよそ一波形ピッチの距離だけ周方向にずらせることを特徴とする請求項4に記載の内部人工器官。
- 7前記波形フィラメントを構成する螺旋巻きパターンおよび前記追加の螺旋巻きパターンが、前記長手方向の軸に沿って異なる螺旋方向に延びることを特徴とする請求項4~6のいずれかに記載の内部人工器官。
- 8前記 波形フィラメント が、前記 第一の螺旋 巻きにおいて第一の相互ピッチを、また、前記第二の 螺旋 巻きにおいて第二の相互ピッチを持ち、これら第一及び第二の 相互 ピッチが 互いに 異なることを特徴とする請求項2 ~ 7のいずれかに記載の内部人工器官。
- 9前記波形フィラメント の少なくとも一つの 螺旋 巻きにおける少なくとも一つの波形の少なくとも一部 の振幅が他より大きな 振幅を持ち、隣接する 螺旋 巻きにおける 波形フィラメント の少なくとも隣接部分が これより小さな 振幅を持つことを特徴とする 請求項8 に記載の内部人工器官。
- 10前記パターン構造において前記第2の波形パターンが前記第1の波形パターンと複数箇所において交差することにより、前記第1の波形パターンが前記第2のパターンにより区切られた複数の中間パターンが繋がった構成となっており、前記中間パターンにおける少なくとも一つの波の振幅が前記第2の波形パターンとの交差部における振幅より大きいことを特徴とする請求項1~9のいずれかに記載の内部人工器官。
- 11前記 パターン 構造が、前記管状体の長さの少なくとも一部に渡っ て規 則的に配置された少なくとも一連の接続要素からな り、 前記少なくとも一連の連続した接続要素が 周方向にずれて設けられて、 前記 パターン 構造内に おいて 少なくとも一つのほぼ螺旋状のパター ンを形 成することを特徴とする請求項 1~10 のいずれかに記載の内部人工器官。
- 12前記 パターン 構造に半径方向の拡張性を与えるために、前記連続した接続要素が、前記 パターン 構造の前記最初の非拡張状態における前記接続要素の直線距離よりも長い細長い部材によって相互に連結されていることを特徴とする請求項11に記載の内部人工器官。
- 13前記細長い部材がほぼSカーブの湾曲 形状を有している ことを特徴とする請求項12に記載の内部人工器官。
- 14前記ほぼSカーブの湾曲 形状 が前記管状体の長手方向の軸の中心軸にほぼ平行に 延びる部分を有して形成されて いることを特徴とする請求項13に記載の内部人工器官。
- 15少なくともいくつかの前記接続要素が、第一の前記 波形フィラメントとこれと隣接する第二の前記波形フィラメント とを対角的に相互接続するストラットからなり、このストラットは、前記 波形フィラメントと一体に形成され 、前記 パターン 構造内の前記 波形フィラメントの螺旋状のパターン の螺旋方向とは異なる方向に 延びて設けられている ことを特徴とする 請求項1~14 のいずれかに記載の内部人工器官。
- 16前記管状壁面における前記ストラットの幅が、前記第一および前記 第二の波形フィラメントの幅よりも大きいことを特徴とする請求項15に記載の内部人工器官。
- 17前 記ストラットがほぼS形の構造を持つことを特徴とする請求項15あるいは16に記載の内部人工器官。
- 18前記接続要 素が、これ が連結する 前記波形フィラメント に完全に一体であると共に互い に交 差するストラットからなることを特徴とする請求項 15~ 17のいずれかに記載の内部人工器官。
- 19前記交差ストラットの うちの 第一のストラットは、 前記波形フィラメントの螺旋状のパターンの螺旋方向とは異なる方向に延び、 前記交差ストラットの うちの第二の ストラットの幅よりも大きなストラット幅を持つことを特徴とする請求項18に記載の内部人工器官。
- 20前記管状体が、中央部分、前記管状体の両端における二つの外側部分、そして、前記中央部分と前記端部の各々との間に 位置する 少なくとも一つの中間部分からなり、 前記管状体の二つの外側部分の少なくとも一つにおける前記パターン構造内の前記波形フィラメントが、ピッチあるいはフィラメント幅の変化との組合せに関わらずに次第に減少する振幅を持ち、少なくとも前記パターン構造の前記最初の非拡張状態において、前記外側部分の自由端が互いに繋がって形成されていることを特徴とする請求項1~19 のいずれかに記載の内部人工器官。
Independent claims20
23 paragraphs, as filed
The present invention relates to an expandable internal luminal prosthesis consisting of a tubular member with first and second ends and a wall surface located between the first and second ends. This wall has a fairly uniform thickness, has a first diameter in the initial non-expanded state that allows the member to enter passages within the body, especially into the vascular cavity, and radiates out from the inside of the tubular member. By applying force towards the member, it is possible to obtain a second diameter in the expanded and deformed state. This second diameter changes in response to the force applied to the tubular member so that the tubular member can be expanded and deformed to dilate the lumen of the passageway in the body. In particular, the present invention relates to an intravascular, divisible internal prosthesis that is particularly useful for repairing or reconstructing blood vessels that have been narrowed or blocked by a disease. Generally, this type of medical device is called a vascular stent or artificial blood vessel.
A stent is an artificial tube that is implanted into a lumen to support the vessel wall and create an unobstructed flow within the lumen. This is of particular importance in the field of angioplasty, which involves the repair and reconstruction of blood vessels. In this particular area, stents are implanted in the vascular system to strengthen crushed, partially blocked, weakened, or abnormally dilated areas of blood vessels. However, more generally, it is possible to use a stent in the lumen of any living duct or duct, including arteries, veins, bile ducts, urinary tract, gastrointestinal tract, tracheal bronchi, cerebral water ducts and genitourinary system. is there. Furthermore, in addition to the human body, it is also possible to use a stent in the lumen of an animal.
Stents are generally identifiable into two types. First, there are self-expandable stents that expand automatically the moment they are released and enter a permanent mounting expansion state. These stents expand to a fixed diameter and cannot reconstruct the original vascular structure if they exceed 2 cm in length. Their drawback is that the physician must install the appropriate device and rely on the information obtained from the fluorograph and angiography equipment. The second type of stent is generally a so-called balloon expandable stent, which comprises a tubular member capable of receiving a balloon of a balloon catheter as a mounting means. The present invention specifically relates to this second type of stent.
A common technique for implanting a balloon-expandable stent into a blood vessel involves mounting a non-expandable contracted stent on a balloon-equipped catheter in a suitable supply system. The catheter is inserted through a cut into the vessel wall and slid along the vessel to place a bridge over the diseased or narrowed portion of the vessel. The stent is then expanded with a balloon catheter against the inner wall of the vessel. This may be done after the blood vessels have been pre-dilated and it is determined that a stent is needed. Alternatively, when the stent is expanded by a balloon, it is also possible to dilate the blood vessel by the stent. In either case, after the balloon has been deflated and the catheter removed, the stent remains mounted and dilated, providing permanent support for its vessels.
An extensive overview of recent vascular stents available can be found in the Handbook of Coronary Stents by Patrick W. Serruys by Patrick W. Serruys and colleagues in the Rotterdam Chest Intervention Cardiology Group. et al. Of the Rotterdam Thoraxcentre Interventional Cardiology Group). This overview is on page 21 ff. In addition, the so-called Palmaz shirt (Palmaz --Schatz Trademark) Stents are described as a standard in the field of stents. The stent consists of a plurality of continuous grooved tubes of stainless steel that are interconnected by one or more bridging means. In fact, the stent has been transplanted to more than 600,000 patients worldwide and is the most widely used and tested, but it still has some drawbacks. The biggest drawbacks are related to the uniformity of the stent-to-vessel ratio and its flexibility in contraction and attachment. The "stent-to-vessel ratio" indicates the degree to which the vessel is supported in the expanded state of the stent, but is preferably not only high, but uniform throughout the stent length. However, due to the unavoidable bridge between the adjacent tubes of the Palmatsu Shirt Stent, there are exposed areas between the adjacent segments of the attached stent, and at these locations the "stent-to-vascular ratio". Decreases to a low value. Another drawback concerns the fairly high rigidity of the stent segment in the contracted and mounted states. The stent is inflexible, and this limitation in flexibility prevents the stent from being placed in its intended location within the human body. Due to the inflexibility of the stent, if the segment is longer than 2 cm, the blood vessels will usually straighten, which usually occurs in the area where the stent is attached, approximately 6 months after surgery. It appears to be the leading cause of restenosis.
Page 63 ff. Of the same reference describes a balloon-expandable stent that has a highly uniform stent-to-vascular ratio and is highly flexible in contractile states.
<p> It involves the Cordis Coronary Stent. The device consists of a single tantalum (Ta) wire that is bent to form a continuous sine wave and spirally wound along a longitudinal axis at both ends of the wire. The part is welded. Radiological Society of North America (RSNA) A similar device was presented at the annual symposium on 11/95). Examples of this marginal stent include intermediate welding as a pattern over the length of the stent. The device is a spirally wound wire that is welded adjacent to each winding so that the wires are highly regularly distributed along the length of the device. Characteristics such as contraction shape and stent-to-vessel ratio are uniform over the entire length in the contracted and mounted states. However, due to its configuration, the device has a very low degree of design freedom when trying to add certain features or eliminate certain drawbacks. Also, the internal stress of the device after winding prevents the provision of reliable welding between adjacent windings, so welding at these welding points and at the ends of the wires is particularly important for the device. It becomes a weak point during expansion.</p><p> An object of the present invention is to provide a balloon-expandable stent with a high degree of uniformity and flexibility and excellent design performance.</p>
<p> For this purpose, according to the present invention<u style="single">Tube</u>Intracavitary artificial organs<u style="single">A hollow tubular tube wall of nearly uniform thickness is machined by laser cutting, electrochemical etching, electromechanical discharge or other suitable processing techniques to create a nearly spiral continuous pattern structure. The pattern structure, which is composed of a tubular member having a tubular wall and forms the tubular wall, has a first corrugated pattern extending substantially spirally and continuously along the longitudinal axis of the tubular body. , The first corrugated pattern is configured to have a plurality of connecting elements that are integrally connected to each other at predetermined intervals by being continuously connected and extended in a spiral shape, and the connecting element is the first. The tubular member extends in a direction intersecting the extending spiral direction of the corrugated pattern and forms a second waveform pattern and extends spirally in the intersecting direction. It has a first diameter in the first non-expanded state that allows intracavitary delivery, and can be expanded and deformed to obtain a second diameter by applying an internal to radial outward force to the tubular member. It is possible, and since this second diameter changes according to the magnitude of the force applied to the tubular member, it is possible to expand the lumen in the body by expanding and deforming the tubular member. Each of the connecting elements is formed by bending in an S shape in the tubular wall at least in the non-expanded state, and the tubular member is extended to the second diameter. And is configured to facilitate deformation.</u></p><p> This structure, which forms the wall of the tubular member, is separated from the hollow tube by, for example, laser cutting or a similar technique that can be done by a skilled person. According to this method, it is possible to make a structure including a pattern extending in a substantially spiral shape with almost no stress. This structure is highly uniform and flexible over the entire length of the device, but does not compromise design freedom, further enhances the functionality of the pattern, and is free to eliminate certain shortcomings. Can be changed to. In addition, the connecting elements, like the rest of the structure, are separated from the pipe and completely integrated with the structure, thus avoiding welding problems in devices of the prior art. A nearly spiral pattern within the structure may be designed as a type of spine for the device to form a spinal column that extends almost continuously upon mounting.</p><p> In the examples according to the invention, the structure of the internal prosthesis consists of continuous filaments separated from the tube wall, with adjacent corrugations arranged approximately spirally along the longitudinal axis of the tubular body. The first spiral winding of the filament around the longitudinal axis of the tubular member forms at least one of the nearly spiral patterns in the structure, at least one of the connecting elements which is an integral extension of the filament. Is connected to a second such winding adjacent to the filament. This example is very similar to the Cordis Coronary Stent mentioned earlier, but does not share the shortcomings of the device.</p><p> In a more specific embodiment of the internal prosthesis according to the invention, in order to improve flexibility in compression and mounting conditions of the device, adjacent windings of filaments are multiple connecting elements less than the number of waveforms in the winding. Are interconnected by. Since there is almost no limit to the degree of freedom in design in the device of the present invention, the number of interconnects between adjacent windings can be freely adapted according to the flexibility of the device. The less connections between adjacent windings, the more flexible the device. The freedom of design allows the number of interconnects between adjacent windings within the device to be varied to suit optimal operation.</p><p> In a preferred embodiment, the internal prosthesis according to the invention has the following characteristics: The structure consists of multiple windings of filament, and the connecting elements to the continuous winding are radially offset to form at least one additional nearly helical pattern of said at least one nearly helical pattern within the structure. To do. In this method, it is possible to obtain a major framework structure that supports the vessel wall while maintaining flexibility during mounting. In particular, in a preferred embodiment according to the invention, at least a portion of the structure of the internal prosthesis consists of a plurality of connecting elements that are approximately equally divided into each winding of the filament, with the connecting elements in the continuous winding having approximately one waveform pitch. It is spirally displaced by the distance of. By shifting the connecting elements by approximately one pitch distance, each continuous connecting element can be connected with a nearly complete waveform of the first pattern. This waveform introduces meaningful play in the spiral spinal column created by interconnected connecting elements, allowing the diameter to expand and allowing the device to expand very slowly across the longitudinal direction. To do. This reduces the so-called shrinkage, in which the device contracts longitudinally as it expands, narrowing the effective range of the device.</p><p> Further, in certain embodiments of the device according to the invention, at least some of the connecting elements diagonally interconnect the first side of the first adjacent waveform with the opposite side of the second adjacent waveform. Consisting of struts, the struts are completely integral with the adjacent waveform and have a direction different from the helical direction of the one nearly helical pattern in the structure. Upon implementation, this structure creates a type of spinal column that extends across a series of connecting elements in a direction different from or opposite to the direction of the one nearly spiral pattern. Such a multi-helical structure can provide considerable hoop strength, despite being flexible and conformal to the vessel wall of the human body.</p><p> Further, in the embodiment of the internal prosthesis according to the present invention, the connecting elements for continuous windings are radially offset by a distance of approximately one waveform pitch. This regular pattern of connecting elements results in one or more continuous spiraling spines formed by continuous struts and each side of the waveform they interconnect with in the mounted state of the device. Be done. These spinal columns form a scaffolding grid that uniformly supports the vessel wall while maintaining flexibility in the mounted state because they are as conformal as possible to the natural state of the vessel. In particular, the lack of the latter has been found to unnaturally straighten blood vessels over certain lengths and is a major cause of late restenosis in the stented area. The embodiments of the present invention can avoid this problem due to the flexibility in the mounting state and the highly conformal mounting shape.</p><p> In order to further improve flexibility while maintaining hoop strength, i.e. the ability to withstand inward radial forces, in certain embodiments of the internal prosthesis according to the invention, the first of the first waveforms. The side, the opposite side of the second waveform and the strut have the first filament width, the opposite side of the first waveform and the first side of the second waveform have the second filament width, the first The width of one filament is formed larger than the width of the second filament. The inventor has confirmed that by making the second filament width smaller than the first filament width, flexibility can be obtained without deteriorating the strength of the device, especially its radial hoop strength.</p><p> Further, in a particular embodiment of the internal prosthesis according to the invention, the struts connecting the opposing sides of the adjacent waveforms of continuous winding have a substantially S-shaped structure. Such a double curved structure of the connecting element gives more play between the interconnected waveforms and provides excellent expandability and stent-to-vascular ratio in the area when the prosthesis is implemented.</p><p> Moreover, in a preferred embodiment of the internal prosthesis according to the invention, the connecting elements each consist of two crossing struts that are completely integral to each of the adjacent waveforms to which they are connected and the connecting elements. During device mounting, the inventor first states that such interconnect elements first rotate around their central axis before all of the applied force acts on the intersection to pull the interconnect elements axially. I'm checking. Therefore, the device incorporates some sort of stress relief mechanism, which allows width to smaller filaments. This not only increases the flexibility of the device, but also improves the radiation opacity. In addition, the cross struts leave a scaffold area or footprint that is fairly unchanged when this structure is mounted, thus increasing the final stent-to-vascular ratio of the device compared to connecting elements that extend almost completely during mounting.</p><p> The fairly unlimited design degrees of freedom gained by the internal prosthesis according to the invention allow the characteristics of the device to be accurately tailored to meet certain requirements. Not only the shape, number and specific part of the connecting element, but also the width of the filament and the shape of the specific part can be freely adapted. By way of example, in certain embodiments of the invention, the filament waveform has a first reciprocal pitch in the first winding of the filament and a second reciprocal pitch in the second winding, the first and second. The pitch of each is different from the others. By varying the mutual pitch of the waveforms, in general, some flexibility can be gained in combination with changes in vascular support in that area.</p><p> Further, in the embodiment of the internal prosthesis according to the invention, at least a portion of at least one waveform in at least one winding of at least one nearly spiral pattern has increased amplitude and in adjacent windings. At least the adjacent portion of the adjacent waveform has a correspondingly reduced amplitude. In this case, the mechanical properties of the device, especially the method of implementation and the stent-to-vessel ratio, can be tailored by offsetting the abutment points of adjacent waveforms.</p><p> In particular, in the embodiment according to the invention, the first pair of adjacent waveforms in the structure of the internal prosthesis are connected by the first connecting element, and the second pair of adjacent waveforms in the structure is the second connecting element. Connected by, between the first and second pairs of connecting elements, at least one waveform of the intermediate pair of waveforms to connect at least a portion of the length of the first and second connecting elements. , Has an increased amplitude. In this case, the inevitable length of the connecting element between adjacent windings of the device is at least partially corrected by the increased amplitude of at least one waveform, resulting in a more uniform stent-to-vascular ratio at the time of mounting. Is obtained.</p><p> Further, it is also possible to form a nearly spirally extending pattern in the structure with a series of nearly spirally offset waveforms, or instead, by the connecting elements themselves. In this regard, in a particular embodiment of the invention, the structure of the internal prosthesis consists of at least a series of connecting elements arranged approximately regularly over at least a portion of the length of the tubular body, in at least a series. The continuous connecting elements are radially offset to form one nearly spiral pattern of said at least one nearly spiral pattern in the structure. In particular, in a preferred embodiment of an internal prosthesis according to the invention, the continuous connecting elements are longer than the linear distance between the connecting elements in the initial non-expanded state of the structure in order to give the structure radial expandability. They are connected to each other by elongated members.</p><p> In the case of this method, the spirally extending spinal column is provided on at least a part of the device and adds to the scaffolding grid of the structure, especially in the mounted state of the device. The addition of one or more such spines can provide the device with considerable hoop strength and support capability without compromising flexibility in the contracted and mounted states of the structure. By increasing the length of the elongated member, it is possible to provide expandable diameters in the individually connected connecting elements, provide additional play in the structure, improve expandability and reduce device shrinkage. This additional circumference allows side branch access beyond the maximum expansion diameter of the stent along the longitudinal axis. In this regard, in certain embodiments of the internal prosthesis according to the invention, the elongated member consists of a substantially S-curve curve. The S-curved members are evenly spaced along the spiral along the longitudinal axis of the tubular body, primarily allowing the device to expand uniformly in the radial direction, and the structure is spiral at the time of mounting. Allows you to move to. In a more specific embodiment, the curvature of the S-curve is arranged approximately parallel to the longitudinal axis of the tubular body so that the member extends uniformly at right angles to the axis. This can prevent the device from twisting and rotating on the balloon catheter as it expands.</p><p> The internal prosthesis according to the invention may have a uniform structure throughout the device, but in a preferred embodiment of the device, the tubular body is the central portion, the two outer portions at both ends of the tubular body, and It consists of at least one intermediate part located between each of the central part and the end part, and these different parts are designed according to a specific function in the device. In this embodiment, when the device is in a non-expanded state, an expanded state, or a transitional state between the non-expanded state and the expanded state, an internal artificial organ is used to accurately provide a specific function or desired action in the relevant part. It is based on the recognition that different parts of the are required to have different functions. The present invention provides the device with this type of tailoring.</p><p> In particular, in the embodiment of the internal prosthesis according to the invention, the waveform within the structure in at least one of the two outer parts of the tubular body is such that the free end of that part is tubular in at least the first non-expanded state of the structure. It has an amplitude that gradually decreases regardless of changes in pitch or combination with filament width so as to substantially cross the longitudinal axis. Such a rectangular-like tubular end of the internal prosthesis prevents the undesired cantilever-like protrusion of the last roll, which can damage the lumen wall when guiding the device to its intended position. Is. In addition, this structure improves the mechanical adhesion between the balloon of the catheter used to manipulate the device in the body and the internal prosthesis. This rectangular end is created by gradually reducing the amplitude and pitch of the last few waveforms to obtain the final smooth transition forming the desired rectangular end. By modifying the filament width in this region, it is possible to further improve the action of this portion.</p><p> Further, in the embodiment of the internal prosthesis according to the invention, the central portion of the tubular body comprises the first number of connecting elements per spiral winding of at least one nearly spiral pattern in the structure, of the intermediate portion. At least one includes a second number of connecting elements in the structure for each spiral winding of at least one nearly spiral pattern in the structure. At this time, since the first number of connecting elements is smaller than the second number of connecting elements, there is a difference in flexibility between the two parts of the tubular body. To be precise, the central portion is more flexible than the intermediate portion due to the smaller number of interconnects between adjacent windings. To adapt to this difference within the structure, in certain embodiments of the internal prosthesis according to the invention, the central and intermediate parts are the first to second number of connecting elements per spiral winding of the pattern. Each is separated from the others by the transitions in order to smoothly change the number of interconnects between adjacent windings into numbers.</p><p> Further, in a particular embodiment of the internal prosthesis according to the invention, the adjacent windings in the central portion include a plurality of equally divided connecting elements, the connecting elements in a continuous winding being only a distance of approximately one waveform pitch. It shifts in a spiral. For example, six adjacent spiral segments with three equidistant connecting elements located approximately 120 ° relative to each other, or six equidistant connecting elements located approximately 180 ° relative to each other. Two opposing spiral segments. This particular design provides the most flexible structure in the central region, both in the contracted and mounted states. After mounting, the structure aligns with the spiral lattice structure it forms, with three consecutively twisted lattice legs in the intermediate region, and only two such in the central region. Show your legs. The intermediate region exhibits greater rigidity to resist expansion by the balloon known as the "dog bone effect", where the edges of the device prematurely open outwards before mounting the central portion to counteract the amount of shrinkage during expansion. In addition, the intermediate region acts as a relief between the central region and the edges of the device.</p>
<figref num="1">FIG. 3 is a isometric view of an example of an expandable intraluminal prosthesis according to the present invention.</figref><figref num="2">It is a top view of the internal artificial organ of FIG.</figref><figref num="3">An alternative embodiment of the interconnect element incorporated into the device according to the invention is shown.</figref><figref num="4">It is an enlarged view of the end part of the internal artificial organ of FIG.</figref><figref num="5">It is a isometric view of the second embodiment of the expandable intraluminal artificial organ according to the present invention.</figref><figref num="6">It is a top view of the device of FIG. 5 in the non-expanded state.</figref><figref num="7">It is a top view of the device of FIG. 5 in the extended mounting state.</figref>
FIG. 1 is a isometric view of an expandable intraluminal prosthesis according to a particular embodiment of the present invention. The internal prosthesis (hereinafter shortly referred to as the stent) consists of a tubular member 1 made from a tubular body of suitable biocompatible material. Thus, for example, higher stainless steel (SST), nickel-titanium (NiTi) based alloys described as Nitinol, several cobalt-based alloys and niobium-titanium (NbTi) based alloys can be used. .. In this case, this material is selected because it has excellent mechanical strength and corrosion resistance, is radiation opaque, and can be confirmed by fluorescence fluoroscopy. In the initial non-expanded state, the tubular member 1 has a first diameter d that allows attachment of the member into passages within the body, especially within the lumen of blood vessels. The member 1 can be expanded and deformed to obtain a second diameter by applying a radial force from the inside, usually by means of a balloon catheter. This second diameter varies depending on the magnitude of the applied force. Inevitably, the member exhibits a certain amount of reversion, so the device retracts slightly after the balloon is removed. Therefore, the second diameter is slightly smaller than the diameter at which the stent is expanded. However, the tubular member can be expanded and deformed to expand the lumen of the passage in the body so that the flow through the lumen such as a blood vessel is not obstructed.
The wall of the stent consists of a fairly continuous configuration, in this example consisting of a continuous filament cut approximately spirally from the tube wall with a width of approximately 0.10 to 0.17 mm. This process can be performed by laser cutting, electrochemical etching, electromechanical discharge or other suitable technique, followed by an appropriate surface treatment such as etching to remove burrs and round sharp edges. Is preferable. In this example, a tubular body with an inner diameter of about 3.0 mm, a wall thickness of about 1.0 mm and a length of about 30 mm was selected as the material. However, other dimensions are also feasible within the scope of the present invention. In particular, the length can be adjusted to the affected portion of the lumen to which the stent is attached. That way, it is not necessary to use multiple stents to cover the entire area. The filament configuration consists of multiple waveforms 2 offset from each other in a spiral pattern around the central longitudinal axis I-I of the device. Continuous winding of filament to keep it in order A --H Are interconnected by one or more connecting elements 31, 32 that are cut from the same tubular body and perfectly integrated into the corrugation. To maintain flexibility in the non-expanded and mounted states, the number of connecting elements per spiral winding is less than the number of waveforms present in that winding. This is clear from FIG. 2, which shows a plan view of the device as if it were cut open. As is clear from this figure, from the connecting element 31 to the next winding, there is a deviation in the radial direction at a pitch of about half a waveform distance of 1 / 2L, and spiral patterns XX and YY are formed. Once implemented, these patterns extend into the spiral spinal column, forming the main framework of the mounting stent, the skeletal lattice. This framework is capable of uniformly and highly supporting the vessel wall over the entire length of the device and withstanding significant inward radial forces. This is called hoop strength.
At the bottom of Figure 2, a portion of the central module portion of the device is shown. The continuous winding of filaments is simply connected by two connecting elements 31 with a displacement of 180 ° from each other. Also, at the top of the figure, three evenly spaced connecting elements 31, 32 show the ends of the adjacent waveforms of the continuous winding of filaments, along with the middle part of the interconnected device. There is. Thus, the skeletal lattice of the mounted device constitutes a single spiral spine in the central region and consists of two spiral spines in the other regions. The latter is less flexible, but has better adhesion to balloon catheters that guide the device into the lumen. It can also counteract the so-called dog bone effect, which causes premature expansion at the tail end of the device. On the other hand, the central portion of the device, i.e. the lower portion of the drawing, is maximized in flexibility and adaptability due to the small number of interconnects between adjacent waveforms within this segment.
In this example, two types of connecting elements, labeled 31 and 32, respectively, are used. Both types of connecting elements include S-shaped struts 3, which are different from the torsional waveform itself, which interconnect the opposing parts of adjacent waveforms of continuous winding of filaments diagonally in the spiral direction (figure). See also 3E). These struts form part of the lattice spinal column described above and are therefore referred to as the main struts. In addition, the second type of interconnect element 32 is provided with an S-shaped second diagonal strut 4 that crosses the first strut (see Figure 3D). Due to this shape, a small force applied axially to the diagonal 3 of the connecting element when the stent is mounted causes the second type 32 interconnect element to first rotate around its central axis. Beginning, the first diagonal 3 receives full force axially only after it is perfectly aligned with the sides of the interconnected waveform. Since the mechanism for reducing looseness and stress is incorporated in this way, the strut width and filament width of the foot of the lattice can be formed thin. This is useful for reducing radiation opacity in this area and for increasing flexibility in non-expanded, contracted, mounted and expanded states. Moreover, the support area covered by this second type of connection element is hardly reduced after device mounting. Therefore, the "skeleton mark" after mounting is larger than that of other types of connecting elements shown in the figure, which are considerably extended at the time of mounting and leave only a thin main strut 3 as a "skeleton mark".
Since the present invention does not impose design restrictions on any part of the device, including interconnect shapes, other shapes are feasible in addition to the types of connection elements shown. Examples of other shapes that can be advantageously used for the device according to the invention are shown in FIGS. 3A-3G. The connecting elements of FIGS. 3A to 3C simply consist of straight struts 3 connecting adjacent waveforms, and the main struts 3 of the connecting elements shown in FIGS. 3D to 3F have a well-defined S-curve shape. This shape gives the structure more play and expandability. The longer this segment, the more play and expandability the structure, especially the spinal ladder created by the connecting elements within the final mounted device, will occur. From the expanded state, it is possible to derive a simple formula that defines the relative increase in strut length and its effect on the extended range of the device.
The main struts 3, that is, the struts that ultimately form the main skeleton or skeleton of the device after mounting, are shown in FIG. 3 by dotted hatching. In certain embodiments, the strut and the corrugated side to which it connects are formed with a first filament width w1 large enough to withstand the axial force applied during device expansion, the other corrugated side, and If possible, other struts of the connecting element are formed at least locally to a second filament width w2 to increase flexibility and reduce radiation opacity. In particular, to increase overall flexibility, the filament width in the central part of the device is modified to reduce the first filament width w1 to about 0.14 mm and the second filament width w2 to about 0.11 mm.
In order to avoid adversely affecting the vascular support of the stent due to a pair of waveforms in the continuous winding of filaments that are not interconnected by the connecting elements, the amplitude of such paired waveforms should be adjusted to the connecting elements elsewhere in the structure. It may be formed to fill the gap created to maintain the length required for the stent. This is clear from, for example, FIG. All adjacent peaks and valleys of a pair of waveforms in a continuous winding are adjacent to each other, albeit not interconnected. This is due to the matching of at least one amplitude of the waveform in such a pair of waveforms. This can be done by increasing the amplitude of both peaks and valleys, expanding only one of them without changing the other, or further increasing the amplitude of either peak or valley while decreasing the amplitude of the other. It implies that. Also, in this regard, the designer is free to adapt the stent design to the optimum response of the stent in the non-expanded, dilated and / or transition states.
The end of the device is formed so as to substantially cross the central axis of the device, avoiding the cantilever that accompanies the usual spiral shape. Therefore, it does not damage the wall of the lumen through which the stent passes. This end is shown in more detail in FIG. The particular shape is obtained by gradually reducing the amplitude of the last few waveforms and matching their mutual pitches. According to the present invention, the filament can be simply cut into a desired pattern, so that a specific shape can be obtained without introducing any stress into the device. The deviant amplitude and mutual pitch can be best confirmed from the plan view of FIG. The end module has a higher stent-to-vessel ratio than the central and intermediate parts due to the increased "metal-to-surface area" in the expanded shape. The more complex structure at the ends shrinks more in the expanded state, resulting in a dense pattern and further increasing the stent-to-vessel ratio.
A second embodiment of the device according to the present invention is shown in FIGS. 5 to 7. This device consists of tubular body 1 and was manufactured using the same technique as in the first embodiment, but in this case, it is not only wound with a single filament, but has a more complicated structure. It has become. However, as in the first embodiment, the structure of the device is composed of a nearly spiral pattern of waveforms 2 that are offset from each other, and the connecting element 33 connects several waveforms in the continuous winding of this pattern. They are connected to each other. The connecting elements in this structure mainly consist of two crossing struts of the type shown in Figure 3D.
Unlike the structure of the first embodiment, the connecting elements 33 in the continuous winding of this pattern are displaced by about one pitch distance. As a result, there is an elongated member 25 between the connecting elements 33 because the connecting elements 33 are linked to each other by a single complete waveform 25. This elongated member formed by the intermediate waveform has an S-curve curve, which is longer than the linear distance between the interconnect elements interconnected thereby, at least in the contracted state shown in FIGS. 5 and 6. For this reason, the spinal ladder formed by such a chain of connecting elements is provided with play and considerable extensibility in the mounting state shown in FIG. Further, since the bending direction of the S curve in the elongated member 25 is considerably parallel to the longitudinal axis of the main body at least in the contracted state shown in FIGS. 5 and 6, the member 25 is uniform in the direction considerably perpendicular to the axis. Allows you to extend to. As a result, the device does not twist or rotate the balloon catheter once it is expanded.
As in the first embodiment, again, the series of connecting elements connected to each other by the pitch distance form a substantially spiral pattern in the structure. Like the staggered waveform itself, these spiral rotation patterns, when expanded, result in a spiral spinal column passing through the structure (see Figure 7). However, these spines run in a different direction than the corrugated spine, in the direction shown by the straight line in Figure 7. The result is a structure with high hoop strength and excellent flexibility in non-expanded and mounted states. Since the device of the present invention has a great deal of design freedom, each part of the device can be adapted to obtain the best overall characteristics for these aspects.
Although the present invention has been described with few examples, the present invention is applicable to a wide range. For a skilled practitioner, many other examples and modifications are possible within the scope of the present invention. For example, some mutual pitches of the waveform can be varied with or without amplitude changes to obtain a suitable stent-to-vessel ratio and flexibility in the area. In addition, it is possible to add a new module portion that can be individually identified in the stent in order to add a specific function. Therefore, transient portions may be inserted between the relatively flexible central portion and the stiffer middle and end portions to reduce structural migration in those portions of the stent. It is also possible to increase the number of connecting elements in one roll of the spiral pattern and increase the number of lattice spines in the mounting device. In this case, the device has greater hoop strength and bearing capacity.
Similarly, in addition to flexibility and stent-to-vessel ratio, filament width and corrugated shape can be varied and adapted to suit specific desired properties. For example, device shrinkage, that is, the amount of length reduction as the device expands from the contracted state to the mounted state, the degree of device reversion, hoop intensity and its radiation opacity. In any case, the invention provides the designer with the greatest degree of freedom possible.
Further, the elongated member connecting a series of connecting elements as shown in the second embodiment does not have to be the same as the waveform of the pattern, and can be introduced as individual elements in the structure. Moreover, these members need not consist of a complete S-curve curve or may not include any S-curve curve. Also, there may be one or more such curves. In this regard too, the designer is completely free to tailor the device to the demand.
7 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7
Every citation, both ways
| Document | Relation | Office |
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| JP852165A | Cites | Japan |
| JP67454A | Cites | Japan |
| JP8336597A | Cites | Japan |
| GB2281865A | Cites | United Kingdom |
78 members in 11 offices
Priority claims10
| Document | Office | Kind | Date |
|---|---|---|---|
| 97201799 | European Patent Office (EPO) | A | |
| 97201799 | European Patent Office (EPO) | A | |
| 972017990 | European Patent Office (EPO) | – | |
| 98201446 | European Patent Office (EPO) | A | |
| 98201446 | European Patent Office (EPO) | A | |
| 982014466 | European Patent Office (EPO) | – | |
| 199797201799 | – | – | – |
| 199898201446 | – | – | – |
| EP19970201799 | – | – | – |
| EP19980201446 | – | – | – |
Members78
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|---|---|---|---|
| EP0884029A1 | European Patent Office (EPO) | A1 | |
| EP0890346A1 | European Patent Office (EPO) | A1 | |
| JPH11128364A | Japan | A | |
| US6117165A | United States of America | A | |
| US2002095206A1 | United States of America | A1 | |
| US2002111669A1 | United States of America | A1 | |
| WO02091958A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO03017870A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US2003149474A1 | United States of America | A1 | |
| EP1341482A1 | European Patent Office (EPO) | A1 | |
| EP1357858A1 | European Patent Office (EPO) | A1 | |
| IL157276D0 | Israel | D0 | |
| CN1479596A | China | A | |
| CN1491097A | China | A | |
| JP2004521720A | Japan | A | |
| JP2004525729A | Japan | A | |
| US6821292B2 | United States of America | B2 | |
| EP0884029B1 | European Patent Office (EPO) | B1 | |
| AT285203T | Austria | T | |
| ATE285203T1 | Austria | T1 | |
| DE69828220D1 | Germany | D1 | |
| US2005090894A1 | United States of America | A1 | |
| ES2231939T3 | Spain | T3 | |
| CN1255084C | China | C | |
| DE69828220T2 | Germany | T2 | |
| CN1267067C | China | C | |
| US7108714B1 | United States of America | B1 | |
| US2007203570A1 | United States of America | A1 | |
| US7329277B2 | United States of America | B2 | |
| EP1357858A4 | European Patent Office (EPO) | A4 | |
| US2008281406A1 | United States of America | A1 | |
| US2008281407A1 | United States of America | A1 | |
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| US2010211152A1 | United States of America | A1 | |
| EP1341482B1 | European Patent Office (EPO) | B1 | |
| AT485014T | Austria | T | |
| ATE485014T1 | Austria | T1 | |
| DE60143308D1 | Germany | D1 | |
| US2010324661A1 | United States of America | A1 | |
| US2010324662A1 | United States of America | A1 | |
| ES2350630T3 | Spain | T3 | |
| JP2011025047A | Japan | A | |
| EP2311410A1 | European Patent Office (EPO) | A1 | |
| EP2311411A1 | European Patent Office (EPO) | A1 | |
| EP2311412A1 | European Patent Office (EPO) | A1 | |
| US7942922B2 | United States of America | B2 | |
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| JP5016708B2This record | Japan | B2 | |
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| EP2311411B1 | European Patent Office (EPO) | B1 | |
| EP2926775A1 | European Patent Office (EPO) | A1 | |
| DK2311411T3 | Denmark | T3 | |
| PT2311411E | Portugal | E | |
| ES2551521T3 | Spain | T3 | |
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| EP2311410B1 | European Patent Office (EPO) | B1 | |
| EP3123984A1 | European Patent Office (EPO) | A1 | |
| EP2926775B1 | European Patent Office (EPO) | B1 | |
| EP2311412B2 | European Patent Office (EPO) | B2 |
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Numbers
- Publication
- 5016708
- Publication, DOCDB
- 5016708
- Publication, EPODOC
- JP5016708B
- Application
- 176484
- Application, DOCDB
- 2010176484
- Application, EPODOC
- JP20100176484
Titles2
- Japanese
- 拡張可能な管腔内部人工器官
- English
- Ditable intraluminal prosthesis
Classification
- CPC, 12
- A61F2/915
- A61F2/88
- A61F2/91
- A61F2002/91508
- A61F2002/91516
- A61F2002/91525
- A61F2002/91533
- A61F2002/91541
- A61F2002/9155
- A61F2002/91558
- A61F2002/91583
- A61F2230/0013
- IPC, 3
- A61F2 82
- A61F2 84
- A61F2 90
