WO2014197957A1

WO2014197957A1 - Method for producing an expansible endoprosthesis structure for the treatment of vascular diseases, and resulting improved endoprosthesis structure

Info

Publication number: WO2014197957A1
Application number: PCT/BR2014/000190
Authority: WO
Inventors: Ana Paula Gomes NOGUEIRA; Marcelo Barbosa MANDELLI; Flávio REIS; Waldemar Fernando Mello MARTINS
Original assignee: Inside Medical Indústria E Comércio De Produtos Médicos Hospitalares Ltda - Me
Priority date: 2013-06-10
Filing date: 2014-06-09
Publication date: 2014-12-18

Abstract

The invention relates to a method for producing an expansible endoprosthesis structure for the treatment of vascular diseases, and to the resulting improved endoprosthesis structure, and represents an inventive solution in the medical field, being particularly useful for the treatment of vascular diseases, especially specific pathologies such as aneurysms and aorta dissections, differing from other solutions in expansible endoprosthesis structures (A), (B), (C) or (D) in that it is designed as a mesh composed of a plurality of sections (s1), ..., (Sn-1), (Sn), which, once closed, forming vertices (v1), (v2), (v3), ... (Vn-1), (Vn) and then circles, exhibit complete freedom of movement between the interlocking vertices around the entire circumference of the plurality of connections (v) defined by the interlocking vertices (v1), (v2), (v3), ..., (vn) between adjacent sections (Sn-1) and (Sn). Moreover, this structure has outstanding fatigue resistance and as a result a long service life, since each section (Sn) is formed by a single thread (1a) which can be optionally interlaced (1a), the structure being bound-off (f) using the end portions (1b) and (1c) of the single thread (1a).

Description

PROCESS FOR OBTAINING EXPANSIBLE ENDROPTHESIS STRUCTURE FOR TREATMENT OF VASCULAR DISEASES AND RESULTING PERFORMANCE ENDROPTHESIS STRUCTURE

APPLICATION FIELD

[1] The present title patent and object of description and claim in this booklet is an inventive solution in the field of application dictated by the medical field, finding outstanding utility in the treatment of vascular diseases, especially for specific pathologies such as aortic aneurysms and dissections.

[2] However, it is noteworthy that the present invention in the form of improvements in the physical structure of the stent graft, technically referred to as a "stent", finds application in every surgical situation in which the need to use this device is defined, and even more whatever the configurative arrangement of its structure, especially the traditional straight tubular, conical tubular and even bifurcated tubular structures.

DEMAND OF INVENTION

[3] The development of improvements in stent graft structure was motivated by the imperative need that, once implanted, this structure be perfectly functional, ie, shipped with quality assurance, ensuring adequate blood flow in the vessel segment requiring intervention and consequently giving total safety to the patient, in the sense that he now has a postoperative with comfort in his cardiac activity. [4] On the other hand, the inventor does not lose sight of the concrete fact that the expandable stent graft must have a differentiated functional life span, where it must have outstanding tensile and fatigue resistance.

[5] Finally, due to the qualitative demand, it is defined as a technical need, also imperative, that the structure of the expandable stent graft is easily adaptable to the anatomy of the vessel segment undergoing intervention and particularly in vessel segments that present marked tortuosity.

REQUIREMENTS OF THE INVENTION

[6] In line with the demand of the invention the applicant has devised "improvements in the physical structure of expandable endoprosthesis" provided with novelty as it ensures the consolidation of a rich and adequate blood flow in the vessel segment (arteries, carotid arteries, coronary and iliac, after implantation, especially in highly tortuous contoured vessel segments, the inventor points out that the use of the "improved structure" expandable stent graft is not obvious or evident from other known state-of-the-art solutions. technique for structures of this nature, and its new constructive concept obtained is the result of an effort to understand disciplines in the medical sector, notably the anatomy of cardiac vessels with marked tortuosity as the technology of manipulation of alloys and the science of materials resistance. Metallic [7] Additionally, in order to make the improved expandable stent graft feasible, a novel assembly and consolidation process has been devised, which will be revealed, thus indicating that the "invention" is provided with industrial applicability and is economically viable and therefore , in view of the strictness of patentability requirements, notably as a patent for invention, as provided in the provisions of Articles 8 and 13 of Law 9.279.

TECHNICAL BACKGROUNDS

[8] In order to provide veracity to the context explained in the introductory table, a brief explanation of the state of the art for stent expandable endoprostheses will be provided, where it will be possible for a person skilled in the art to recognize both its positive and limiting aspects. , for a later moment to discuss the added advantages, with the introduction of the improvement object of claim in this cartouche.

[9] a. The expandable stent graft: Also known technically by the term "stent graft", this has revolutionized interventional practice for treating ischemic and symptomatic heart disease. In clinical practice, they are increasingly being prescribed to a larger number of patients.

[10] In 2007 alone, more than 43,000 stent graft units were used by the Unified Health System (SUS) in Brazil, where such popularization in the medical environment resides in the concrete fact that compared to conventional techniques (surgeries). treatment) through the method Endovascular therapy decreases the risks to which the patient is exposed, and generates less trauma.

[11] b. Technological basis: an expandable stent for the treatment of vascular diseases presents a constructive concept formed by a metallic tubular structure, which can be cylindrical, conical or even split, whose body is made in the form of a mesh or wire whose threads are made of metallic material. with a high degree of flexibility, allowing the expandable endoprosthesis to present a small volume when implanted, via a special catheter, and an expansive volume at the end of this implant. In addition to said structure it may receive a polymeric coating. In the state of the art there are endoprosthesis structures formed by independent sections of metallic wires, mainly nitinol and steel, which are sutured to the sheath without connection to each other.

[12] The primary function of the tubular structure is to provide support to the endoprosthesis itself near the wall of the diseased segment of the recipient vessel, so that it must ensure its perfect accommodation, while the polymeric coating is intended to redirect the stent. blood flow in this weakened segment of the vessel.

[13] c. Identification of the macro problem: the careful observation of this type of conventional solution in expandable endoprosthesis structure reveals that its constructive configuration generates limitations in the tubular structure's ability to make curves, since its curvature is restricted to the coating itself.

[14] d. Solutions to Solve the Macro Problem: In an attempt to find an effective solution to the problem of limiting adequacy of the tubular body that makes up the structure of the expandable stent graft in segments of vessels with accentuated tortuosity, numerous constructive dispositions for this structure were presented, among which the solution in which a structure formed by weaves, or mesh, technically called "wall" is highlighted. stent ", where its constructive concept is characterized by the fact that the weft is manufactured from a single wire where each vertex of the section is connected to the vertex of the adjacent section.

[15] Critical analysis of this type of solution reveals that while meeting the flexibility requirement, these structures exhibit considerable rigidity, so that on uneven surfaces they do not settle well and tend to close the lumen, thereby losing their primary function and consequently creating an imminent danger to the well-being of the patient.

[16] In addition, they generally have at least one constraint point for structural body movement in each section, notably at a section vertex connected to the adjacent section vertex, where we can technically define this as a "locked vertex". .

PROPOSAL OF THE INVENTION

[17] As evidenced in the background topic of the technique, the inventor directed the development of a new stent graft solution that eliminates the patient safety problem using an expandable stent graft implant, notably the stent graft. possibility of lumen closure due to deficient adherence of the structure to the wall of the diseased segment of the vessel to be treated, especially when this diseased segment is provided with severe tortuosity.

[18] a. Developmental paradigms: the improvements in structure for expandable stent graft, had their development based on the relationship between flexibility and constructive arrangement of the metallic structure, especially the mesh arrangement, and the imperative requirement for the new constructive arrangement of this structure is to provide the same degree of total freedom of movement in interference between all vertices formed by two adjacent sections, this being the distinguishing feature of the invention.

[19] A second paradigm to follow is to achieve a differentiated condition of improved structure durability, based on the higher tensile and fatigue strength of each section.

[20] b. Inventive constructive concept: The improved structure applied in expandable stent graft consists of a plurality of independent sections with each vertex of these sections being connected to one vertex of the adjacent section. All of its vertices are connected, but in none of them there is locking, which makes the expandable stent graft have greater adaptability to the anatomy of the vessels.

[21] In order to meet the fatigue and wear safety requirement of the improved structure, it is characterized by presenting conventional zigzag mesh sections where, however, as a distinctive feature each section is obtained. from a single wire whose resulting sections can be presented both as a single "unbraided" wire as well as a "braided" single wire, and in both configurations these sections are characterized by high tensile strength of the structure for repositioning and in addition favors the replacement of the expandable endoprosthesis in the inside the catheter.

FILE DESCRIPTION

[22] The complement the present description of the specification in order to obtain a better understanding of the characteristics of this patent, accompanying this, attached set of drawings which depicts a preferred embodiment for ^λ improvement in structure, physics stent graft "as well as its procurement process, where:

Figure 1.1 is a representation in perspective view of a first preferred embodiment for ^x improvement in physical structure expandable stent ", showing its constructivity especially its formation of a plurality of different tubular sections, revealing the total degree of freedom of movement in the interlacing region of the multiple vertices formed in these sections;

Figure .1.2 is an illustration in perspective view of a first preferred embodiment ^for, improvement in the physical structure of expandable stent "polymeric coating provided at the ends sutured;

Figure 1.3 is a pictorial representation of the first step of forming a section provided for "process of obtaining expandable stent graft structure", notably in its first embodiment of the stent graft, specifically single-ring annular conformation, at the beginning of zigzag conformation, defining a plurality of up and down vertices;

Figure 1.4 is an illustrative view of the first section forming step provided for the "process of obtaining expandable stent graft structure", notably in its first embodiment of the. stent graft, specifically single-ring annular conformation, at the end of zigzag conformation, defining a plurality of up and down vertices;

Figure 1.5 is an illustrative view of the second section forming step provided for the "process of obtaining expandable stent graft", notably in its first embodiment of the stent graft, specifically closing the annular wire conformation. single, showing the early stage of the spring-forming operation by spiral winding of the converging ends of the single wire;

Figure 1.6 is an illustrative view of the second section forming step foreseen for the "process of obtaining expandable stent graft structure", notably in its first embodiment of the stent graft, specifically closing the annular wire conformation. single, showing the intermediate stage of the spring-forming operation by spiral winding of the converging ends of the single wire;

Figure 1.7 is an illustrative view of the second section forming step, provided for "process of obtaining expandable stent graft structure", notably in its first embodiment of the stent graft, specifically closing the single-wire annular conformation, highlighting the final stage of the spring forming operation by spiral winding of the converging ends of the single wire ;

Figure 1.8 is a representation in illustrative view of the "process of obtaining expandable stent graft structure", notably in its first embodiment of the stent graft, showing the constructivity of a first finished section and beginning of the making of the second section, notably the first one. step of forming a section, specifically single-ring annular forming, in zigzag shape, defining a plurality of vertices, up and down that second section;

Figure 1.9 is an illustrative representation of the "process of obtaining expandable stent graft structure", notably in its first embodiment of the stent graft, showing the constructivity of a finished first and second section and beginning of the third section fabrication, notably the first step of forming a section, specifically single-ring annular forming, in zigzag shape, defining a plurality of vertices, up and down that third section;

Figure 2.1 is a perspective view representation of a second preferred embodiment for enhancing the physical structure of expandable endoprosthesis ", evidencing its constructivity especially its formation by a plurality ^" of differentiated tubular sections, revealing the total degree of freedom of movement. at interlacing region of the multiple vertices formed in these sections;

Figure 2.2 is a representation in perspective view of a second preferred embodiment for the improvement in physical structure ^Λ expandable stent "polymeric coating provided at the ends sutured;

Figure 2.3 is an illustrative view of the first section forming step foreseen for the "process of obtaining expandable stent graft structure", notably in its second embodiment of the stent graft, specifically forming the closure spring for each section;

Figure 2.4 is an illustrative view of the second section forming step provided for the "process of obtaining expandable stent graft structure", notably in its second embodiment of the stent graft, specifically single-ring annular conformation, at the beginning of zigzag forming, defining a plurality of up and down vertices;

Figure 2.5 is an illustrative view of the second section forming step provided for the "process of obtaining expandable stent graft structure", notably in its second embodiment of the stent graft, specifically single-ring annular conformation, at the zigzag conformation end, defining a plurality of up and down vertices;

Figure 2.6 is an illustrative view representation of the "process of obtaining expandable stent graft structure", notably in its second embodiment. endoprosthesis, showing the constructivity of a first section still open and beginning of the making of the second section, notably of the first step of forming a section, specifically of single-wire annular conformation, defining a plurality of vertices, for up and down this second section;

Figure 2.7 is an illustrative view of the "process of obtaining expandable stent graft structure", notably in its second embodiment of the stent graft, showing the constructivity of a plurality of still open sections;

Figure 2.8 is an illustrative view representation of the "process of obtaining expandable stent graft structure", notably in its second embodiment of the stent graft, specifically the third heat treatment step of the obtained mesh;

Figure 2.9 is a representation in illustrative view of the "process of obtaining expandable stent graft structure", notably in its second embodiment of the stent graft, specifically the fourth closing step of the mesh sections;

Figure 3.1 is a perspective view representation of a third preferred embodiment for enhancing the physical structure of expandable endoprosthesis, "evidencing its constructivity especially its formation by a plurality of differentiated tubular sections, revealing the total degree of freedom of movement in the interlacing region of the multiple vertices formed in these sections;

Figure .3.2 is a perspective view representation. a third preferred embodiment for the physical structure improvement of an expandable stent graft provided with a sutured polymeric coating at the ends;

Figure 3.3 is an illustrative view of the first section forming step provided for the "process of obtaining expandable stent graft structure", notably in its third embodiment of the stent graft, specifically single-ring annular conformation, at the beginning of zigzag forming, defining a plurality of up and down vertices;

Figure 3.4 is an illustrative view of the first section forming step foreseen for the "process of obtaining expandable stent graft structure", notably in its third embodiment of the stent graft, specifically single-ring annular conformation, at the zigzag conformation end, defining a plurality of up and down vertices;

Figure 3.5 is an illustrative view of the second section forming step foreseen for the "process of obtaining expandable stent graft structure", notably in its third embodiment of the stent graft, specifically single-ring annular conformation and interlaced, showing the beginning of the single-wire interlacing operation;

Figure 3.6 is an illustrative view of the second section forming step provided for the "process of obtaining expandable stent graft structure", notably in its third embodiment of the stent graft, specifically the annular wire forming. single and interlaced, showing an intermediate stage of the single-wire interlacing operation;

Figure 3.7 is an illustrative view of the second section forming step provided for the "process of obtaining expandable stent graft structure", notably in its third embodiment of the stent graft, specifically single-ring annular conformation and interlaced, showing a final stage of the single-wire interlacing operation;

Figure 3.8 is an illustrative view of the second section forming step provided for the "process of obtaining expandable stent graft ''^' , notably in its third embodiment of the stent graft, specifically closure of the annular conformation. of the single and interlaced yarn, showing the early stage of the spring-forming operation by spiral winding of the converging ends of the single yarn;

Figure 3.9 is an illustrative view of the second section forming step foreseen for the "process of obtaining expandable stent graft structure", notably in its third embodiment of the stent graft, specifically closing the annular wire conformation. unique and interlaced, showing the final stage of the spring forming operation by spiral winding the converging ends of the single wire;

Figure 3.10 is a representation in illustrative view of the "process of obtaining expandable stent graft structure", notably in its third embodiment of the stent graft, showing the constructivity of a first finished section and beginning of the making of the second section, notably the first step of shaping a section, specifically single-wire annular shaping, in zigzag shape, defining a plurality of vertices up and down of that second section as well as highlighting the interleaving condition of the vertices with respect to the first section; and

Figure 3.11 is an illustrative view of the "process of obtaining expandable stent graft structure", notably in its third embodiment of the stent graft, showing the constructivity of a finished first and second section and beginning of the third section fabrication, notably the first step of forming a section, specifically single-ring annular forming, in zigzag shape, defining a plurality of vertices, up and down that third section;

Figure 4.1 is a representation in perspective view of a fourth embodiment ^Λ for the improvement in physical expandable stent structure "having a top section with hooks;

Figure 4.2 is a perspective view representation of a variant of the fourth embodiment for upgrading the expandable stent graft "provided with 3 uncoated sections, with the hooks present in the upper section.

Figure 4.3 is a representation in perspective view of a second variant of the fourth embodiment for the improvement in physical ^λ expandable stent structure "where the fully coated stent, the hooks being present in the section nearest the upper end; Figure 4.4 shows an enlarged perspective view of a section of the expandable stent graft with the anchor system for the fourth embodiment for physical structure improvement of the expandable stent ";

Figure 4.5a shows an enlarged perspective view of the first step of shaping a hook segment forming a section with hooks, specifically shaping the closure spring for each part, which enables the fourth embodiment to be made for further improvement. physical structure of expandable stent graft "

Fig. 4.5b shows a pictorial representation of a portion of a hooked segment already folded;

Figure 4.5c shows a top view representation of a part of a hooked segment, evidencing its conformation an arc;

Fig. 4.5d shows an illustrative view of a portion of a hooked segment, showing the opposite side of the spring, where an angled cut is made to obtain a pointed end;

Fig. 4.5e shows a pictorial representation of the joining of a plurality of hooked segments for the composition of a single section, still open; and

Fig. 4.5f shows an illustrative top view representation of the joining of a plurality of hook segment parts forming a closed, already closed section.

DETAILED DESCRIPTION [23] The following detailed description is to be read and interpreted with reference to the drawings presented, representing four embodiments for the "expandable stent graft physical structure enhancements", as well as the respective procedures for obtaining each other, and is not intended. In limiting the scope of the invention, it is limited only to that set forth in the claim framework.

[24] a. Constructive concept of the stent graft structure:

[25] a.l First embodiment; As evidenced by FIG. 1.1 the improved stent tube structure (A) is preferably manufactured from heat treated self-expanding material comprising a plurality of closed and independent circular sections (S1), (S2),. . (Sn-1), (Sn) connected (v) to each other by interlacing their vertices (vl), (v2), (v3),

(vn-1), (vn), see figure. 1.7, presenting a total degree of freedom of movement between the intertwined vertices along their surrounding contour of two adjacent sections. In addition, structure (A) may be covered with polymeric material (g) such as expanded polytetrafluoroethylene where it is fixed by suture (h) only to the end sections (Sl) and (Sn) of the tubular structure (A) as shown by Figure 1.2.

[26] a.2 Constructive concept of section (Sn): This is evidenced by Figure 1.7, where each section (Sn) is fabricated using a single wire (la) whose length is defined by a plurality of vertices (vl). , (v2), (v3),.

(vn-1), (vn), in zigzag, where the ends of this single wire segment (la) have defined ends (lb) and (lc) respectively, being arranged in a convergent direction on a given section of the forming section by consolidating the closing (f) of the section (Sn), thus eliminating the use of auxiliary wires commonly used in conventional structures for expandable endoprostheses.

[27] In turn, the closing (f) of section (Sn) is unprecedented, as it is obtained by winding these ends (lb) and (lc) respectively along a single thread segment (la), specifically on the adjacent sides of a certain vertex (V), see figure 1.7, thus guaranteeing the flexibility and total return to the expanded state status of the stent graft, without any interference.

[28] a.3 Process for obtaining the section (Sn), is dictated by the sequential steps:

- Section profile conformation (El): As shown in Figure 1.3, from a single wire body (la), it has its first end (lb) attached to any point of support, whereupon the operator holds the entire segment of that single wire (1a) and manipulates the second end (1c), such that it promotes a zigzag conformation, defining a plurality of vertices (v1),

(v2), (v3), (vn-1), (vn), and completing a circular, elliptical, or correlate perimeter, where the remaining body (la) is adjacent to the segment region near the first end (lb), see figure 1.4;

Consolidation of section (E2): as evidenced by figures 1.6 and 1.7 respectively; where the operator promotes the completion of interlacing on a discrete single wire segment (la) through winding ends (lb) and (lc) in this segment, thus obtaining a double spring closure (f), see figure 1.7.

[29] a.4. Endoprosthesis obtaining process (A), is dictated by the sequential steps:

- Body Construction (El): Embedded logic lies in consolidating the construction of a section (Sl) as described in the steps of the process of making a section.

(Sn), where as evidenced by figures 1.8 and 1.9 respectively, only from a finished first section (Sl) begins the preparation of the second section (S2), and the section profile forming step (S2) is conducted in identity with the operation provided for the first section (Sl), with the differential only that the operator manipulates the single wire body (la) interlaced (V) with the respective vertices (vl) , (v2),

(v3),. . . . (vn-1), (vn) from the first section (Sl), until the completion of the section consolidation step (S2), also identical to that revealed for the first section (Sl), with this constructive logic being maintained for obtaining the subsequent sections (Sn-1), (Sn), until the stent graft (A) is obtained as revealed by Figure 1.1;

- Heat treatment (E2): where the stent graft (A) is taken to heat treatment procedure, through its exposure to high temperatures (between 300 and 550 C °) inside an oven (Fr) for a period between 10 and 40 minutes ;

- Dressing the structure (E3): as shown by figure 1.2, where the polymeric coating (g) is fixed to the body of the structure (A), this application being consolidated by applying suture (h) to the entire contour only of the extreme sections (SI) and (Sn) of this structure (A).

[30] B Second Embodiment Structure:

[31] b.l Constructive concept of the structure: As evidenced by Figure 2.1, the improved stent tubular structure (B) is preferably manufactured from self-expanding material consisting of a plurality of closed and independent circular sections.

(SI), (S2),. . . (Sn-1), (Sn) connected (v) to each other by interlacing their vertices (vl), (v2), (v3),

. . . (vn-1), (vn), see figure 2.9, showing total degree of freedom of movement between the intertwined vertices along their surrounding contour of two adjacent sections. As in the first embodiment, structure (B) may be covered with polymeric material (g) such as expanded polytetrafluoroethylene where it is fixed by suture (h) only to the end sections (SI) and

(Sn) of the tubular structure (B), see figure 2.2.

[32] b.2 Constructive concept of section (Sn), as evidenced by figure 2.9 where each section (Sn) is fabricated using a single thread (la), whose length is defined by a plurality of vertices (vl) , (v2), (v3),. . . (vn-1), (vn), zigzag, see Figure 2.4, where the ends of this single wire segment (1a) have defined a linear end (1b) and a closing spring end (1c) arranged in a convergent sense and adjacent to each other in a given segment of the conforming section (Sn), as shown in figure 2.5.

[33] The closure (f) of section (Sn) is unprecedented because it is obtained by coupling the end (lb) to end spring closure (lc), see figure 2.9, thus ensuring the flexibility feature and full return to the expanded state of the stent graft without any interference.

[34] b.3 Section obtaining process (Sn), is dictated by the sequential steps:

- Form spring end (E1): As evidenced by Figure 2.3, where a single spring end (1c) is formed from a single wire (1c), using equipment from the lathe type, and the other end (1b) of this wire (1a) is held in the form of a linear segment. The inside diameter of the spring (lc) is specified to be about 20 to 40% smaller than the diameter of the wire body (la), thus enabling a definitive fit when closing the section (Sn);

- Section profile conformation (El): as shown by figure 2.4, from a single wire body (la), it has its first end (lb) fixed to any point of support, whereupon the operator holds the entire segment of this single wire (1a) and manipulates the second spring-loaded end (1c), such that it promotes zigzag conformation by defining a plurality of vertices (v1), (v2), (v3) , (vn-1),

(vn), and completing a circular, elliptical, or related, perimeter where the spring-loaded end (1c) is adjacent to the segment region near the first end (1b), see Figures 2.4 and 2.5 respectively.

[35] The difference from the first embodiment of structure (A) lies in the fact that section (Sn) is not closed upon its conformation, which will only occur at the end of the frame mesh assembly (B) in a closing operation of all sections (Sn);

[36] b.4. Endoprosthesis obtaining process (B), is dictated by the sequential steps:

- Body construction (El): Embedded logic lies in consolidating the construction of a section (Sl) as described preliminarily in the steps of the process of making a section (Sn), where only from a first section (Sl) not When the closed section is started, the second section (S2) is made, and the section profile forming step (S2) is conducted in identity with the operation provided for the first section (Sl), with the differential that the operator manipulates the body of the single strand (1a) interlaced (V) with the respective vertices (vl), (v2), (v3),. . . . (vn-1), (vn) from the first section (Sl), until the completion of the section consolidation step (S3), also identical to that revealed for the first section (Sl), with this constructive logic being maintained for obtaining the subsequent sections (Sn-1), (Sn), until the open mesh of the stent graft (B) is obtained as revealed by Figures 2.6 and 2.7.

- Heat treatment of the mesh (E2): where the open mesh of the stent graft (B) is taken to the heat treatment procedure through its exposure to high temperatures inside an oven (Fr) as shown in figure 2.8, where the open mesh of the stent graft (B) is exposed to a temperature between 300 and 550 ° C for a period between 10 and 40 minutes;

- Mesh closure (E3): where after the open mesh of the stent graft (B) receives the appropriate heat treatment, the operator closes all sections (SI), (S2),. . . (Sn-1), (Sn) by engaging the linear ends (lb) within their respective closure spring ends (lc), as evidenced by Figure 2.9.

- Dressing the structure (E4): as shown in figure 2.2, where the polymeric coating (g) is fixed to the body of the structure (A), and this application is consolidated by applying suture (h) around the entire contour. only the end sections (SI) and (Sn) of this structure (B).

[37] C. Third embodiment structure

[38] cl Constructive concept of the structure: As evidenced by Figure 3.1, the improved endoprosthetic tubular structure (C) is preferably manufactured from heat-treated self-expanding material comprising a plurality of closed and independent circular sections (Sl), ( S2). . . (Sn-1), (Sn) connected (v) to each other by interlacing their vertices (vl), (v2), (v3),. . . (vn-1), (vn), presenting total degree of freedom of movement between the intertwined vertices in all their surrounding contour of two adjacent sections.

[39] In addition, structure (C) may be covered with polymeric material (g) such as expanded polytetrafluoroethylene where it is fixed by suture (h) only to the end sections (Sl) and ( Sn) of the tubular structure (C) as shown by Figure 3.2.

[40] c.2 Constructive concept of section (Sn): as evidenced by Figure 3.8, where each section (Sn) is fabricated using a single twisted wire (ld) whose length is defined by a plurality of vertices. (vl), (v2), (v3),. . . (vn-1), (vn), in zigzag, whose ends of this single twisted wire segment (ld) have defined ends (lb) and (lc) respectively, and are arranged in a convergent direction on a given segment of the conforming section. consolidating the closure (f) of the section (Sn), thus eliminating the use of auxiliary wires commonly used in conventional structures for expandable endoprostheses.

[41] In turn, the closing (f) of section (Sn) is unprecedented, as it is obtained by winding these ends (lb) and (lc) respectively with a single wire segment (le), see figure 3.8, ensuring thus the flexibility feature and full return to the expanded state of the stent graft without any interference.

[42] c.3 Section obtaining process (Sn), is dictated by the sequential steps:

- Section profile conformation (El): as shown by figure 3.3, from a single wire body (la), it has its first end (lb) fixed to any point of support, whereupon the operator holds the entire segment of that single wire (1a) and manipulates the second end (1c), such that it promotes a zigzag conformation, defining a plurality of vertices (v1),

(v2), (v3), (vn-1), (vn), and completing a circular, elliptical, or correlate perimeter, where the remaining body (la) hints adjacent to the segment region near the first end (lb), see figure 3.4;

- Section Interlacing (E2): As evidenced by Figure 3.5 the operator manipulates the second end (lc) adjacent to the segment region near the first end (1b) and initiates the interlacing procedure of the single-wire body (1a), at all contours of the section (Sn), thereby defining an interlaced wire (1d), as shown by figures 3.6 and 3.7 respectively; such that at the end of this interlacing the end (1c) is adjacent to the region of the single body segment (1a) near the first end (1b); and

Consolidation of section (E3): as evidenced by figures 3.8 and 3.9 respectively; where the operator promotes the interleaving on a discrete single-wire segment (le) by winding the ends (lb) and (lc) on this segment (le), thereby obtaining a spring-like closure (f), see figure 3.9 .

[43] c.4. Process of obtaining the stent graft (C), is dictated by the sequential steps:

- Construction of the body (El): Embedded logic lies in consolidating the construction of a section (Sl) as described in the steps of the process of making a section (Sn), where as evidenced by figures 3.10 and 3.11 respectively, where only from a first section

(51) finalized begins the preparation of the second section

(52), where the section profile (Sl) and section interlacing (S2) steps are conducted in identity with the operations provided for the first section (Sl), with the differential only that the operator manipulates the body of the single wire (1a) and then the interlaced wire (1d) interlaced (V) with the respective vertices (vl), (v2), (v3),. . . . (vn-1), (vn) of the first section (Sl), until the completion of the consolidation section (E3), also identical to that revealed for the first section (SI), and this constructive logic is maintained for obtaining subsequent sections (Sn-1), (Sn), until endoprosthesis (C) is obtained. as revealed by figure 3.1;

- Thermal treatment of the mesh (E2): where the open mesh of the stent (C) is taken to the heat treatment procedure through its exposure to high temperatures inside an oven (Fr) as shown in figure 2.8, where the open loop of the stent (B) is exposed to a temperature between 300 and 550 ° C for a period between 10 and 40 minutes; and

- Dressing the structure (E3): As evidenced by figure 3.2, where the polymeric coating (g) is fixed to the body of the structure (C), and this application is consolidated by applying suture (h) around the entire contour. only the end sections (SI) and (Sn) of this structure (C).

[44] D. Fourth embodiment structure

[45] d.l Brief introduction; This fourth embodiment of the endoprosthesis structure was designed to meet with maximum effectiveness the technical effect that should be measured in an endoprosthesis, where its radial force can be defined as the resistance imposed to decrease its diameter. This force, when applied to the vessel to be treated, produces a mechanical interference that acts on the stent anchorage at the selected site. For this anchorage to be adequate, it is recommended, at the moment of its selection, an oversizing of the endoprosthesis diameter in relation to the blood vessel.

[46] d.2 Technical restrictions: however Oversized endoprostheses greater than 30% are not indicated and are considered excessive as they may cause dilation in the necks of the injured vessels.

[47] In turn, the oversizing that causes a loosening between the vessel wall and the surface of the stent graft weakens the fixation of the stent, converging to a displacement of the stent graft from its previously defined position (in the vessel tissue requiring intervention). deployed.

[48] This displacement is further explained by the fact that it may occur because the required radial force between the vessel's inner wall and the stent graft's outer wall is not sufficient to resist the actuation of a cast of forces such as gravity, hemodynamic flow. , among other factors that compete against anchoring. This dislocation is technically defined as migration, which ultimately converges into complication of endovascular treatment, and therefore compromising the quality and effectiveness of the endoprosthesis implant.

[49] Given the scenario presented and even more pertinent to the restrictive aspects from the point of view of anchorage and stability of the stent when in contact with the vessel, it is the objective of the fourth embodiment of the stent to expand its anchoring capacity and consequently avoiding the undesirable. "migration" effect.

[50] Prior art anchoring systems are known in the art, usually in the form of independent hooks attached to the proximal section thereof. However, the location of most of these hooks limits the possibility of repositioning the stent Once the delivery catheter sheath is released, the hooks immediately attach to the vessel wall.

[51] In view of the limitations imposed by the anchoring solution outlined in the previous paragraph, it is the objective of the fourth embodiment to ensure anchoring capability and consequently to avoid the undesirable "migration" effect without limiting the possibility of endoprosthesis repositioning.

[52] To make the proposed objective of the fourth embodiment feasible, a differentiated anchoring system in the form of "fixation fittings" applied to the body end of a stent graft has been devised, where in a preferred embodiment it is presented in "a section provided with a plurality of anchor hooks" which is in turn incorporated into the body structure of the anchor section which is a component part of the endoprosthesis itself.

[53] In a nutshell, it is relevant as a differential that "fasteners" such as hooks are part of the anchor section that integrates the stent graft and not an independent component that needs to be attached to the structure promotes greater safety. to the device,

[54] d.3 Constructive concept of the structure in the form of an endoprosthesis with anchor section (D1), as evidenced by Figure 4.1, uncoated, consisting of two conventional sections (SI), (S2), where the In its upper part a differentiated section with hooks (Se) is applied.

[55] Alternatively, in Figure 4.2 a variant of stent (D2) with uncoated sections (SI) is shown. (S2) and (S3) where to it, in its upper part is applied a differentiated section with hooks (Se).

[56] Finally, in Figure 4.3 a second variant of the stent graft (D3) is presented, which in turn is fully coated, with the upper part being applied with a differentiated section with hooks (Se).

[57] d. From the constructive concept of the anchored section; as evidenced by Fig. 4.4 the anchored section (Se), consisting of a plurality of anchor segments (Sei). . . (Sen) which connect to each other by mechanical interference between the spring (2) of an anchor segment (Sen-1) and part of the wire segment (1) of the anchor segment (Sen).

[58] In turn, each anchor segment (Sen) is composed of a wire segment (1) of expandable metallic material, where one end has a spring defined (2a) and the other end has a pointed segment (2). 3).

[59] d5. Anchor section manufacturing process: The anchor section (Se) is constructed using templates using the following sequential steps:

- Spring formation (El): with a thread segment (1) at one end is formed the spring (2a), as shown in figure 4.5a;

- Bend formation (E2): with the wire segment (1) on a cylindrical template which gives the segment a circumferential arc shape, as shown in figure 4.5c, folds are made, which configure one or more segments in "V", whereas in the thread segment (1) at the opposite end of the spring a socket (2b) is formed as shown in Figures 4.5b and 4.5c; Heat treatment (E3): anchor segment heat treatment (Sci);

- Anchor end definition (E4): After being treated, the locking arc (2b) receives an angled cut defining a pointed end (3), as can be seen in Figure 4.5d;

Steps 1 through 4 are repeated as many times as necessary to obtain the anchor segments (Sei), (Se2), (Se3),. . . (Sen) required for mounting the anchor section (Se);

- Anchor section conformation (E5): Then the anchor segments are joined (Sei), (Se2),

(Se3),. . . (Sen) to complete the desired diameter. Joining is accomplished by wrapping the wire segment part

(1) of an anchor segment (Se2) with the spring (2) of the anchor segment (Sei), and so on, being maintained by the mechanical interference that the spring (2a) imposes on the wire segment part (1). ) as shown in Figure 4.5e;

Anchor section closure (E6): where last part of the thread segment (1) of segment (Sei) is engaged in the spring (2b ') of segment (Sen), as shown in figure 4.5f;

- Application of the anchor section (E7): after completion of the anchor section (Se), it is incorporated into the metal structure of the stent graft, which may be coated or uncoated, joining other sections (SI), (S2). ),. . . (Sn) as shown in Figure 4.1;

- Application of the polymeric coating (E8): the polymeric coating (G) is sewn over the structure as shown in Figures 4.2 and 4.3. evidencing that an endoprosthesis has an anchor section (Se), that is, provided with hooks.

[60] In addition, the anchor section (Se) may be located on any segment of the stent (D1), (D2), (D3), or (D4) metal frame to specifications for each implant type.

[61] The choice of embodiments of the invention in the form of "expandable stent graft physical structure improvements", as well as their respective procurement processes, as claimed in this booklet, described in this detail topic of the invention are provided by way of example only. for example. Changes, modifications, and variations may be made to any other embodiment of the physical structure of the stent graft and its procurement processes by those skilled in the art without, however, departing from the objective disclosed in the present application, which is exclusively defined by attached claims.

[62] It is apparent from what has been described and illustrated that the "PROCESS FOR OBTAINING EXPANSIBLE ENDOPROSTHESIS STRUCTURE FOR TREATMENT OF VASCULAR DISEASES AND RESULTANT ENDROPTHESIS" hereinafter complies with the rules governing the invention patent Industrial Property Law, deserving for what was exposed and as a consequence, the respective privilege.

Claims

CLAIM

I ( ^a ) "PERFORMANCE ENDROPTHESIS STRUCTURE" presented in tubular form of expandable endoprosthesis manufactured from self-expanding and heat-treated material, where this tubular form is shaped like a mesh, which is composed of a plurality of closed circular sections (SI), ( S2). . . (Sn-1), (Sn) connected (v) to each other by interlacing their vertices (vl), (v2), (v3),. . . (vn-1), (vn), where this structure may or may not be covered by polymeric material (g), such as expanded polytetrafluoroethylene (ePTFE), fixed to its body by suture (h), where the mesh obtained is characterized by presenting full degree of freedom of movement between the intertwined vertices (V) in all surrounding contour of their adjacent circular sections (SI), (S2),. . . (Sn-1), (Sn);

( ^A ) "PERFORMED ENDROPROSTH STRUCTURE" according to claim 1, wherein for a first embodiment of the expandable stent (A) each section (Sn) is provided with a plurality of vertices (vl), (v2), ( v3),. . . (vn-1), (vn), zigzag in a circular or elliptical outline characterized in that it is formed of a single wire segment (1a) where its ends (1b) and (1c) respectively are arranged in convergent direction in a determined section segment (Sn) in conformation;

( ^A ) "PERFORMANCE ENDROPTHESIS STRUCTURE" according to claim 2, the closure (f) of which section (Sn) is characterized by the winding of the ends (lb) and (lc) in the double spring closure segment (la) (f) ); specifically on the adjacent sides of a given vertex (V); ( ^A ) "PERFORMANCE ENDROPROTHESIS STRUCTURE" according to claim 1, wherein for a second embodiment of expandable stent graft (B) each section (Sn) is characterized by being composed of a single wire (la) where one end is defined by a linear end (lb) and the other by a closing spring end (lc);

^(A ) "PERFORMED ENDOSTHRESIS STRUCTURE" according to claim 4, the closure (f) of which section (Sn) is characterized by the engagement of the linear end (lb) of the wire (la) within its respective spring end; closure (lc);

( ^A ) "Enhanced Endoscopic Structure" according to Claim 1, wherein for the third embodiment of the expandable stent (C) the single wire (1a) is characterized by being braided (1d) throughout its contour;

^A ) "PERFORMED ENDOSTHRESIS STRUCTURE" according to claim 6, wherein for the third embodiment of the expandable stent (B) the closure (f) of the section (Sn) is characterized by the winding of the ends (lb) and ( 1c) respectively next to a single segment (1e) of single wire (1a);

^A ) "PERFORMED ENDOSTHRESIS STRUCTURE" according to claim 1, wherein for the fourth embodiment of the expandable endoprosthesis (D1) it is characterized in that at least its upper end has an anchor section (Se) composed of the union of a plurality of anchor segments (Sci). . . (Sen) which connect to each other with the spring (2) of an anchor segment (Sen-1) and the wire segment (1) of the anchor segment (Sen), whereby The anchor segment (Sen) is comprised of a wire segment (1) of expandable metal material, where one end has defined a spring (2a) and the rear end has defined a pointed segment (3);

^A ) "PROCESS FOR OBTAINING EXPANSIBLE ENDROPTHESIS STRUCTURE FOR TREATMENT OF VASCULAR DISEASES" where for the first embodiment of the expandable endoprosthesis (A) the process of obtaining the section (Sn) is characterized by the following steps:

- Section profile conformation (El), from a single wire body (la), this has its first end

(lb) fixed to any point of support, whereupon the operator holds the entire segment of that single wire (la) and manipulates the second end (lc), promoting a zigzag conformation defining a plurality of vertices (vl),

(v2), (v3), (vn-1), (vn), and completing a circular, elliptical, or related perimeter, where the remaining body (1a) is adjacent to the segment region near the first end (1b); and

- Consolidation of the section (E2) by winding the ends (lb) and (lc) in the segment (la), obtaining a double spring closure (f);

^A ) "EXPANSIBLE ENDROPTHESIS STRUCTURE PROCESSING PROCESS FOR TREATMENT OF VASCULAR DISEASES" according to claim 9, wherein the process for obtaining the first embodiment of the stent (A) is characterized by the following steps:

- Construction of the body (El), only from a finished first section (SI) begins the construction of the second section (S2), and the section profile forming step (S2) is conducted in identity with the operation provided for the first section (SI), with the operator manipulating the body of the single wire (la) interlaced (V) with the respective vertices (vl), (v2), (v3),. . . . (vn-1), (vn) from the first section (SI), until the completion of the section consolidation step (S2), also identical to how revealed for the first section (SI), and this constructive logic is maintained for obtaining the subsequent sections (Sn-1), (Sn), until endoprosthesis (A) is obtained;

- Heat treatment (E2), where the open mesh of the stent (A) is taken to the heat treatment procedure, through its exposure to high temperatures inside an oven (Fr), where the open mesh of the stent (B) is exposed to a temperature between 300 and 550 ° C for a period between 10 and 40 minutes; and

- Wear the structure (E3), where the polymeric coating (g) is fixed to the body of the structure (A), and this application is consolidated by applying suture (h) all around the edge of the end sections only (SI ) and (Sn) of this structure (A);

^A ) "PROCESS FOR OBTAINING EXPANSIBLE ENDROPTHESIS STRUCTURE FOR TREATMENT OF VASCULAR DISEASES" where for the second embodiment of expandable endoprosthesis (B) the process of obtaining the section (Sn) is characterized by the following steps:

- Forming spring end (El), where from a single wire (la) is formed a closing spring end (lc), which may be made use of mechanical lathe equipment, and the other end (lb) of this wire (1a) is held in the form of a linear segment, with the spring inside diameter (lc) being specified to be about 20 to 40% smaller than part of the wire body (1a); and

- Section profile conformation (E2), from a single wire body (la), has its first end (lb) fixed to any support point, whereupon the operator holds the entire segment of that single wire (1). 1a) and manipulates the second spring-loaded end (1c) such that it promotes zigzag conformation by defining a plurality of vertices (v1), (v2), (v3),. . .

. . (vn-1), (vn), and completing a circular, elliptical, or related perimeter, where the spring-loaded end (lc) is adjacent to the segment region near the first end (lb), where the section (Sn ) is not closed;

^A ) "EXPANSIBLE ENDROPTHESIS STRUCTURE PROCESSING PROCESS FOR TREATMENT OF VASCULAR DISEASES" according to claim 11, wherein the process for obtaining the second embodiment of the stent graft (B) is characterized by the following steps:

- Body construction (El), embedded logic lies in consolidating the construction of a section (SI) as described preliminarily in the steps of the process of making a section (Sn), where only from a first section

(51) not closed, preparation of the second section begins

(52), wherein the section profile forming step (S2) is conducted in identity with the operation provided for the first section (SI), with the differential that the operator manipulates the single wire body (la) performed interlacedly (V) with the respective vertices (vl), (v2), (v3),. . . . (vn-1), (vn) from the first section (SI), until the completion of the section consolidation step (S3), also identical to how revealed for the first section (SI), and this constructive logic is maintained for the obtaining of the following sections (Sn-1), (Sn), until the open loop of the stent (B) is obtained;

- Heat treatment of the mesh (E2), where the open mesh of the stent (C) is taken to the heat treatment procedure, through its exposure to high temperatures inside an oven (Fr) the open mesh of the stent (B) is exposed to a temperature between 300 and 550 ° C for a period between 10 and 40 minutes;

- Closure of the mesh (E3), where after the open loop of the stent (B) receives the appropriate heat treatment, the operator closes all sections (SI), (S2),. . . (Sn-1), (Sn) by engaging the linear ends (lb) within their respective closure spring ends (lc); and

- Wear the structure (E4), where the polymeric coating (g) is fixed to the body of the structure (A), and this application is consolidated by applying suture (h) around the entire contour of the extreme sections (SI) only. ) and (Sn) of this structure (B);

^A ) "PROCESS FOR OBTAINING EXPANSIBLE ENDROPTHESIS STRUCTURE FOR TREATMENT OF VASCULAR DISEASES" where for the third embodiment of expandable endoprosthesis (C) the process of obtaining the section (Sn) is characterized by the following steps:

- Section profile conformation (El), from a single wire body (la), this has its first end (lb) attached to any support point, whereupon the operator holds the entire segment of that single wire ( 1a) and manipulates the second end (1c) such that it promotes a zigzag conformation by defining a plurality of vertices (v1), (v2), (v3),. . . . . (vn-1), (vn), and completing a circular, elliptical, or related perimeter, where the remaining body (1a) is adjacent to the segment region near the first end (1b);

- Section Interlacing (E2), the operator manipulates the second end (lc) adjacent to the segment region near the first end (lb) and initiates the single wire body interlacing procedure (la) throughout the section contour (lc). Sn), thus defining an interlaced thread (Id), at the end of this interlacing the end (1c) is adjacent to the region of the single body segment (1a) near the first end (1b); and

- Consolidation of section (E3), the operator promotes the completion of interlacing in a discrete single-wire segment (le) by winding the ends (lb) and (lc) in this segment (le), thus obtaining a spring-like closure. (f);

^A ) "EXPANSIBLE ENDOSTHRESIS STRUCTURE PROCESSING PROCESS FOR TREATMENT OF VASCULAR DISEASES" according to claim 13, wherein the process for obtaining the third embodiment of the stent graft (C) is characterized by the following steps:

- Construction of the body (El), where only from a finished first section (SI) begins the preparation of the second section (S2), and the steps of forming the section profile (Sl) and interlacing the section (S2) are conducted in identity with the operations provided for the first section (Sl), where the operator manipulates the body of the single wire (la) and then the interlaced wire (ld) interlaced (V) with the respective vertices. (vl), (v2), (v3) ,. . . . (vn-1), (vn) from the first section (Sl), until the completion of the section consolidation step (E3), also identical to that revealed for the first section (Sl), with this constructive logic being maintained for the obtaining of the following sections (Sn-1), (Sn), until the stent graft (C) is obtained;

- Treatment (E2), where the open mesh of the stent graft (C) is taken to the heat treatment procedure through its exposure to high temperatures in an oven (Fr) where the stent graft (C) is exposed to a temperature between 300 and 550 ° C over a period of 10 to 40 minutes; and

- Wear the structure (E2), where the polymeric coating (g) is fixed to the body of the structure (C), and this application is consolidated by applying suture (h) around the entire contour of the extreme sections (SI only). ) and (Sn) of this structure (C).

15 ^a ) "PROCESS FOR OBTAINING EXPANSIBLE ENDOSTHRESIS STRUCTURE FOR TREATMENT OF VASCULAR DISEASES" where the process of obtaining the fourth embodiment of the stent (D), notably to obtain the anchorage section (Se) is characterized by the sequential steps :

- Spring formation (El): with a thread segment (1) at one end is formed the spring (2a);

- Bend formation (E2): with the wire segment (1) on a cylindrical template which gives the segment a circumferential arc shape, folds are made, which configure one or more "V" segments, whereas in the wire segment (1) at the opposite end of the spring is formed by a socket (2b);

Heat treatment (E3): anchor segment heat treatment (Sci);

- Definition of the anchor end (E4): After being treated, the locking arc (2b) receives an angled cut defining a pointed end (3);

Steps (E1) through (E4) are repeated as many times as necessary to obtain the anchor segments (Sei), (Se2), (Se3) ,. . . (Sen) required for mounting the anchor section (Se);

- Anchor section conformation (E5): Then the anchor segments are joined (Sei), (Se2), (Se3),. . . (Sen) in order to complete the desired diameter, where the union is performed by wrapping the wire segment part (1) of an anchor segment (Se2) with the spring (2) of the anchor segment (Sei), and so on, being maintained by the mechanical interference that the spring (2a) imposes on the thread segment part (1);

Anchor section closure (E6): where in the last part of the thread segment (1) of the segment (Sei) is fitted in the spring (2b ') of the segment (Sen);

Anchor section application (E7): After completion of the anchor section (Se), it is incorporated into the metal structure of the stent graft, which may be coated or uncoated, joining other sections (Sl), (S2). ,. . . (Sn); and

- Application of the polymeric coating (E8): The polymeric coating (G) is sewn onto the metal frame.

^A ) "EXPANSIBLE ENDOPROSTHESIS STRUCTURE" according to claims 8 and 15, characterized in that the anchor section (Se) may be located on any segment of the metal structure.