CN205729570U - Ink vessel transfusing implant and implant is deployed in the delivery apparatus in health tremulous pulse - Google Patents

Abstract

The utility model relates to an intravascular implant and a delivery device for deploying the implant in a body artery. The utility model provides an intravascular implant, comprising: a first portion extending along a longitudinal axis, the first portion comprising a generally tubular graft, the generally tubular graft defining a a generally circular opening of the longitudinal axis, the first portion including a second end defining a generally elliptical opening about the longitudinal axis; and a second portion, the second portion has a first end that includes a generally tubular graft that defines a generally elliptical opening relative to the longitudinal axis to allow the first portion The second end of the second portion extends into a generally oval opening of the second portion, the second portion having a bifurcation extending into two branches extending along the longitudinal axis.

Description

Intravascular implants and delivery devices for deploying implants in arteries of the body

technical field

The utility model relates to an intravascular implant and a delivery device for deploying the implant in a body artery.

Background technique

An aneurysm is an abnormal dilation of one or more layers of the arterial wall, usually due to structural defects caused by hardening of the arterial wall or other systemic defects such as aortic dissection due to high blood pressure. The generally accepted method of treating aneurysms in the abdominal aorta (ie, "abdominal aortic aneurysm" or "AAA") is by surgical repair, which involves replacement of the aneurysmal segment with a prosthetic device. The procedure is a major undertaking but comes with high risks and high rates of mortality and morbidity.

Typical AAA surgical repair is performed through an abdominal incision to allow the physician access to the aorta. Once the aorta is accessible, the aorta can be clamped to allow the surgeon to open the aorta and suture one end of the graft close to the heart. The other end of the graft is sutured to the aorta at the location past the aneurysm. This allows blood to flow from the heart around the weak area of the aorta.

An alternative to surgical repair is the use of endovascular therapy, the catheter-directed technique used to treat aneurysms, especially for AAA. Endovascular therapy has been facilitated by the development of vascular stents, which can and have been used in conjunction with standard or thin-walled graft materials to form stent-grafts or endografts. Potential advantages of minimally invasive treatments include reduced surgical morbidity and mortality and shorter hospital and intensive care unit stays.

One problem with using AAA endografts (or endoprostheses) is that most, if not all, AAA endoprostheses are configured to present the AAA as an infrarenal AAA. The subrenal typically presents a sufficient landing zone for the graft to achieve a tight seal between the inner surface of the vessel wall of the aorta and the outer surface of the endoprosthesis. Where the distance between the renal artery and the aneurysm (ie, "neck length") is less than 15 mm, it is generally accepted that complications may arise from the use of endoprostheses designed for infrarenal presentation. Therefore, in the presentation of neck length less than 15 mm, it is generally believed that the use of existing AAA endoprostheses will inevitably lead to complications for the case of juxtarenal AAA, pararenal AAA, or suprarenal AAA.

Others in the field have attempted to overcome the deficiencies of existing AAA endoprostheses by utilizing a technique known in the art as "fenestration." This technique relies on handcrafted custom fenestrations to allow the incorporation of the renal and superior mesenteric arteries into this custom endoprosthesis for juxtrenal AAA to suprarenal AAA. In one aspect of the fenestration technique, a physician can manually open or fenestrate an off-the-shelf AAA implant. The drawbacks of the physician's modified fenestrated implant are that the implant is not FDA-cleared, thus requiring the physician to apply for an oversight waiver; and that the physician may spend several hours making the fenestrated implant. To reduce these deficiencies, manufacturers have offered custom fenestrated implants based on imaging of the aneurysm 6-12 weeks prior to scheduled implantation. However, one drawback of this technique is that the unique anatomy of the renal arteries can render custom implants useless. For example, additional renal or hepatic arteries may be involved, as well as upwardly directed renal arteries. Additionally, custom-made implants often require long cycle times during which the anatomy of the AAA can change significantly, resulting in misalignment of branch arteries with the fenestration. Although physicians are able to modify known implants on the day of implantation (to avoid the previously mentioned time-lag problem with custom implants), custom fenestrations due to angulation of the anatomical An offset from ideal alignment, therefore, such physician modified implants (as well as custom implants) may still be suboptimal.

Contents of the invention

Therefore, we have designed an implantable endoprosthesis that overcomes the shortcomings of custom fenestrations, freeing physicians from the need to hand-fabricate custom implants hours before transplant surgery. Also, the present invention overcomes the problem associated with implants made to order weeks in advance of the actual AAA procedure that the anatomy or aneurysm may have changed during the order of the implant as well as the actual implant. In brief, the present invention provides three key improvements: (1) ease of use simplifies deployment one fenestration at a time; (2) in situ alignment of each ostium with target branch arteries, leading to improved clinical outcomes; and (3) the overall profile of the endoprosthesis is ultra-low (i.e., smaller than the 16 French of the larger native artery, and in most case less than 12French).

Thus, the inventive device comprises a first part, a second part and a retaining structure for one (or even both) of the first part and the second part not heretofore available in the prior art. The first portion extends along the longitudinal axis and includes a generally tubular graft defining a generally circular opening disposed about the longitudinal axis. The first portion includes a second end defining a generally elliptical opening about the longitudinal axis. The second portion extends along the longitudinal axis and has a first end that includes a generally tubular graft that defines a generally elliptical opening relative to the longitudinal axis to allow for opening of the first portion. The second end extends into the generally oval opening of the second portion. The second part has a bifurcation extending into two branches extending along the longitudinal axis.

We have also designed another variation of the endoprosthesis, which includes a first part, a second part, and a third part communicating with a retaining structure, and the retaining structure can be used with one or all of the first part to the third part. Specifically, a first portion extends along a longitudinal axis and has a first end defining a generally circular opening orthogonal to the longitudinal axis, wherein the retaining barb is coupled to a retaining structure connected to Usually circular opening. The first portion includes a second end defining a generally elliptical opening about the longitudinal axis. The second portion extends along the longitudinal axis and has a first end defining a generally elliptical opening relative to the longitudinal axis to allow the second end of the first portion to extend into the generally elliptical opening of the second portion middle. The second portion has a second end defining a generally circular opening orthogonal to the longitudinal axis. The third portion extends along the longitudinal axis and has a first end that defines a generally elliptical opening relative to the longitudinal axis to allow the second end of the second portion to define a generally elliptical opening relative to the third portion. The opening nests here. The third portion has a bifurcation extending into two branches extending along the longitudinal axis.

In another variation, an endovascular implant is provided that includes three generally tubular sections and retaining structures for the first and third tubular sections. In particular, the first portion extends along the longitudinal axis and has a first end defining a generally circular first opening orthogonal to the longitudinal axis, wherein the retaining barb is coupled to a retaining structure connected to the to a generally circular opening. The first portion includes a second end defining a generally elliptical opening about the longitudinal axis; the second portion extends along the longitudinal axis, the second portion has a first end defined relative to the longitudinal axis A generally elliptical opening is formed to allow the second end of the first portion to extend into the generally elliptical opening of the second portion, the second portion having a second end defining a generally elliptical opening perpendicular to the longitudinal axis. The second opening is circular. The third portion extends along the longitudinal axis and has a first end that defines a generally circular third opening orthogonal to the longitudinal axis to allow the second end of the second portion to be positioned relative to the first end of the third portion. One end is nested thereto, and the first end of the third portion has a retaining member coupled to a generally circular third opening. The third portion has a bifurcation extending into two branches extending along the longitudinal axis.

In addition to the above-described embodiments, other features described below can be used in combination therewith. For example, each of the first, second, and third portions includes a plurality of stent hoops spaced apart along the longitudinal axis and attached to the graft material to define a stent-graft composite implant. body, each stent hoop having a sinusoidal configuration disposed about a longitudinal axis with apexes spaced apart along the longitudinal axis; one apex of one stent hoop disposed between two apexes of the other stent hoop; generally tubular graft comprising a synthetic material selected from the group consisting of nylon, ePTFE, PTFE, polyester, and combinations thereof; a plurality of stent hoops disposed on the inner surface of the stent graft; a first circumferential opening around The longitudinal axis of the first portion near the first end is formed through the graft material so that, when the implant is deployed in the abdominal artery, the first circumferential opening faces toward the mesenteric artery; the second circumferential opening surrounds the The longitudinal axis of the first portion is formed through the graft material so that, when the implant is deployed in the abdominal artery, the second circumferential opening faces the renal artery to allow passage from the renal artery to the second circumferential opening. fluid communication; a third circumferential opening is formed through the graft material about the longitudinal axis of the second portion such that when the implant is deployed in the abdominal artery, the third circumferential opening faces the other renal artery , to allow fluid communication from the renal artery to the third circumferential opening; the first portion is radially adjustable relative to the second portion such that the first circumferential opening on the first portion is generally aligned with the first circumferential opening on the second portion The openings are diametrically opposed and a gap is defined by the intersection of corresponding oval openings of the first and second portions; a stent-graft tubular extension is provided for insertion into each of the two branches to allow fluid flow from the first portion The first openings flow through the second and third parts, and to the respective branches and out through the respective extensions.

Description of drawings

The above and other features and advantages of the invention will become apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings.

Fig. 1 has shown the first embodiment of the present utility model with the semi-exploded perspective view;

Figure 1A shows certain parameters for joining two parts with maximum overlap;

Figure 1B shows certain parameters for joining the two parts with maximum overlap;

Figure 1C shows an arterial branch stent-graft or a bridging stent-graft;

Fig. 2 shows the second embodiment of the present utility model in half exploded view;

Fig. 3 shows a third embodiment of the present invention in a half-exploded view;

Figure 4 shows a branch extension that may be used to extend the flow channel of the bifurcated branch of Figures 1-3;

FIG. 5 is a prototype of a fourth embodiment of the present invention using components selected from the first to third embodiments;

Figure 6 shows the first embodiment as located in a representation of the abdominal aorta;

Figure 7A shows a delivery device for use in the present invention in a simplified perspective view; and

Figure 7B shows an enlarged perspective view of the distal end (the end opposite the catheter handle).

The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate presently preferred embodiments of the present utility model, and are used to explain the features of the utility model (wherein, the same Reference numerals indicate the same elements).

detailed description

The following detailed description should be read with reference to the accompanying drawings, wherein like elements are labeled with like numerals in the different drawings. The drawings, which are not necessarily drawn to scale, depict selected embodiments and are not intended to limit the scope of the invention. This detailed description illustrates the principles of the invention by way of example and not limitation. This description will clearly enable those skilled in the art to make and use the invention, and describes various embodiments, adaptations, variations, substitutions and uses of the invention, including what is presently believed to be the best way to practice the invention. best way.

As used herein, the terms "about" or "approximately" for any numerical value or range indicate that a portion or some of the components are allowed for suitable dimensional tolerances for the intended purpose as described herein. More specifically, "about" or "approximately" may refer to a value range of ±50% of the listed value, for example, "about 50%" may refer to a value range of from 51% to 99%. In addition, the terms "patient", "host", "user" and "subject" as used herein refer to any human or animal subject and are not intended to limit the system or method to human use, although the present invention Use of the novel in human patients represents a preferred embodiment. In this application, use of the terms "cranial" or "caudal" is used to indicate a relative position or orientation with respect to the individual receiving the implant. When "cranial" is used, the term indicates a position or orientation closer to the heart; while the term "caudal" indicates a position or orientation further from the subject's heart.

Figure 1 shows a first embodiment of an endovascular implant (100) that may be used with branch extensions in EVAR procedures for AAAs other than infrarenal AAAs. In other words, implant 100 may be used in AAAs that are classified as juxtarenal AAAs, pararenal AAAs, or suprenal AAAs due to their particular configuration. In particular, the implant 100 is formed as a combination of three main elements: (a) a first tubular first part; (b) a second tubular part with bifurcations; and (c) a keep part. The first portion 102 extends along the longitudinal axis L-L. The first portion 102 includes a suitable graft material, generally in the form of a tubular graft 104a. Graft 104a is configured to define a generally circular opening 105 orthogonal to longitudinal axis L-L. In this particular embodiment, a retention structure may be used to connect the retention barb 106 to the generally circular opening 105 . The first portion 102 includes a second end 108 having graft material defining a generally elliptical opening 109 about a longitudinal axis L-L. The elliptical opening 109 may be formed by dividing the generally tubular graft material at an angle other than 90 degrees relative to the longitudinal axis L-L.

Continuing in FIG. 1 , there is provided a second portion 116 extending along the longitudinal axis L-L. In this second part 116, the first end 115 is provided by a suitable graft material, generally in the form of a tubular graft 104a. Tubular graft 104a defines a generally elliptical opening 114 relative to longitudinal axis L-L to allow second end 108 of first portion 102 to extend into generally elliptical opening 114 of second portion 116 (or, conversely—elliptical). shaped opening 114 extending into the second end 108 of the first portion). As mentioned earlier, the second portion 116 has a bifurcation 118 that extends into two branches 120, 122 that may be configured to extend along the longitudinal axis.

Each branch may be connected to a corresponding extension 400a and 400b, as shown in FIG. 4 . Branch extensions 400a and 400b allow blood to flow through first portion 102, second portion 116 into branches 120 and 122, and then into respective extensions 400a and 400b, which are implanted into respective left Lateral common iliac artery and right common iliac artery.

The construction of the various parts and extensions is very similar. In particular, each of the first portion 102 and the second portion 116 may include a plurality of stent hoops (104b or 204b) spaced apart along the longitudinal axis L-L and passed through suitable Technology is attached to the graft material to define a composite stent-graft in the form of implant 100. Each stent hoop 204b may have a sinusoidal configuration disposed about the longitudinal axis with apexes AP1, AP3, AP5...APn spaced along the longitudinal axis relative to apexes AP2, AP4, AP6...APn+1 (where , n is an odd integer including 0). Note here that one apex (eg, AP2) of one stent hoop is disposed between two apexes (eg, AP1 and AP2) of the other stent hoop. In a preferred embodiment, the graft material may be a synthetic material selected from the group consisting of nylon, ePTFE, PTFE, polyester and combinations thereof. Preferably, the plurality of stent hoops 204b are disposed on inner surfaces of the stent graft, including inner surfaces of branch extensions. Details of the construction of the stent hoops and graft material are shown and described in U.S. Patent Application S.N. 14/316,151 (Attorney Docket No. CRD5524USNP), filed June 26, 2014, which is incorporated herein by reference .

In FIG. 1, a first circumferential opening 103 is formed through the material of the graft 104a around the longitudinal axis of the first portion 102 near the first end 104 so that when the implant 100 is deployed in the abdominal artery, The first circumferential opening 103 faces toward a mesenteric artery (eg, the superior mesenteric artery shown). A second circumferential opening 107 is formed through the material of the graft 104a around the longitudinal axis of the first portion 102 such that the second circumferential opening 107 faces towards the renal artery when the implant 100 is deployed in the abdominal artery. On the second portion 116, another circumferential opening 113 is passed through the material of the graft 104a around the longitudinal axis of the second portion 116 so that when the implant 100 is deployed in the abdominal artery, the circumferential opening 113 facing the other renal artery.

With our design, we were able to account for variations in the bioanatomy in which the renal arteries are oriented relative to the abdominal aorta, which connects to the heart. 6, it can be seen that the first portion 102 is radially adjustable (i.e., rotatable about the longitudinal axis L-L as indicated by “R1”) in the abdominal aorta AB relative to the second portion 116 such that the first portion 102 on the The first circumferential openings 107 are correctly oriented towards the infrarenal arteries RN1 and RN2. In most cases, the first circumferential opening 107 is oriented generally diametrically opposite the circumferential opening 113 in the second portion 116 . Regardless of whether the inferior renal arteries are diametrically opposed, the intersection of the respective oval openings 109, 114 through the first portion 102 and second portion 106 defines a gap G for blood flow to the right gonadal artery GA or the inferior mesenteric artery MA .

Referring to Figure 1A, one consideration should follow to facilitate use of this exemplary implant. Specifically, the circumferential opening (113 or 117) should be spaced a maximum distance ( y _max1 or y _max2 ). For example, the circumferential opening 113 should be at a maximum distance of y _max1 (as measured parallel to the axis LL) from the most distant point 116e on the circumferential opening of the graft 116 . Likewise, the circumferential opening 107 should be at a maximum distance of _ymax2 (as measured parallel to the axis LL) from the furthest point 102e on the circumferential edge of the graft 102 to ensure a good seal between the graft and the abdominal artery . It is to be noted that the minimum overlap distance is the minimum longitudinal distance of the overlap between the two parts that is sufficient to ensure a good seal between the two implant parts. Another consideration is the longitudinal offset distance (along axis LL) between the two renal arteries (ie, "renal offset distance"). By virtue of the invention, a given range of kidney offset distances can be covered by implants with a given maximum overlap. As an example, a kidney offset distance of 5 mm could be used with an implant with a _ymax of 10 mm, while a kidney offset of 12 mm would require an implant with a greater _ymax . Thus, there are examples where, depending on the nature of the actual anatomy, a clinic may be required to keep an inventory of a certain number of implants with different kidney offset distances. For example, a clinic may stock a first stock keeping unit (“SKU”) similar to FIG. 1A with a minimum kidney offset distance of about 5 mm and a range of kidney offset distances (in steps of, say, 2 mm) until FIG. 1B . SKUs in the configuration of . In FIG. 1B , the implant was configured with a kidney offset distance of ROD1 > y max1 and _ROD2 > y _max2 . In a preferred embodiment, each longitudinal overlap distance y _max1 or y _max2 is about 5 mm, while the kidney offset distance ROD1 or ROD2 can be up to about 40 mm and most preferably, each of ROD1 or ROD2 is about 5 mm to about 25 mm.

Although when the most distal point (116e) on the circumference of one graft (116) is aligned with the most distal point (102e) on the circumference of the ellipse for the other graft (102), the two circumferential openings are shown are diametrically relative, but it should be noted that many different radial orientations (relative to axis L-L) may be provided depending on the nature of the arterial anatomy being presented. In most cases, it is believed that the illustrated arrangement ( FIG. 1A ) with circumferential openings 113 and 107 offset by approximately 150 degrees is sufficient as the first SKU in most cases of AAA. However, as the case may be, additional SKUs may be provided for other ranges of angular distance (eg, 30-90 degrees relative to each other with respect to axis L-L).

Referring to Figure 1C, an arterial stent graft extension (or bridging stent, as is known in the art) 424 may be used for insertion into the circumferential openings 104 and 130 so that lateral arteries may be incorporated into the flow of the implant. The extension 424 has a suitable biocompatible graft material 424a similar to that of the main portion mentioned earlier. The extension is configured as a generally tubular flow-through structure. In one embodiment, extension 424 has a generally circular opening 424b on one end 425a. The extension 424 tapers from a first end 425a toward a smaller, generally circular second extension opening 424c near the other end 425b. The arterial stent graft extension 424 is configured to be inserted into at least one of the circumferential openings of the first and second portions with a retainer disposed near each end 425a and 425b to retain the extension to the implant main part or blood vessel. The arterial extension or bridging stent-graft 424 may have at least one stent cuff 426 expandable to support the arterial stent-graft 424a. Alternatively, stent hoop 426 may be a plurality of individual stent hoops connected to each other via the graft material for extension 424 .

Fig. 2 shows another embodiment of the implant of the present invention. In Figure 2, the implant 200 has four main components: (a) the cranial or first tubular section; (b) the medial tubular section 210; (c) the caudal tubular section, which bifurcates into two branches and (d) a retention structure that assists in maintaining either or both of the cranial portion and the caudal portion.

From a first portion 202 extending along the longitudinal axis L-L, the portion of the implant 200 can include a first end 204 defining a generally circular opening 205 orthogonal to the longitudinal axis L-L. A retention structure with retention barbs 206 may be provided. The retaining structure extends from the generally circular opening 205 for coupling to retaining barbs 206 . First portion 202 moving downward along longitudinal axis L-L has a second end 208 defining a generally elliptical opening 209 about longitudinal axis L-L. The elliptical opening 209 may be divided by tubular structures at angles other than 90 degrees relative to the longitudinal axis in order to provide an ellipse of suitable size.

Turning to second portion 210, this portion of implant 200 extends for a suitable length along longitudinal axis L-L, with first end 212 defining a generally elliptical opening 213 relative to longitudinal axis L-L. The oblong opening 213 formed into the tubular structure allows the second end 208 of the first part 202 to extend into the generally oblong opening 213 of the second part 210 while still leaving a gap G between the two parts. The second portion 210 moving downward along the longitudinal axis also has a second end 214 defining a generally circular opening 215 orthogonal to the longitudinal axis L-L.

A third portion 216 extending along the longitudinal axis L-L is provided. The third portion 216 has a first end 218 defining a generally elliptical opening 219 relative to the longitudinal axis L-L. Furthermore, the elliptical opening 219 allows the second end 214 of the second portion 210 to nest relative to the generally elliptical opening 219 of the third portion 216 while still leaving a gap G between the portions 210 and 216, This allows blood to flow to the appropriate artery. It will be noted that the third portion 216 has a bifurcation 220 which extends into two separate branches 222, 224 which extend along the longitudinal axis L-L.

The construction of the various parts and extensions in this second embodiment is very similar to that shown in Figure 1 and previously described in the first embodiment. Each of the first section 202, the second section 210, and the third section 216 has a plurality of individual stent hoops 204b, 210b, 226b spaced apart along the longitudinal axis L-L. and attached to the graft materials 204a, 210a to define the stent-graft composite endoprosthesis 200. As mentioned earlier, each stent hoop 204b, 210b, 226b has a sinusoidal configuration disposed about a longitudinal axis L-L, wherein the apex of each stent hoop is spaced apart along the longitudinal axis relative to the apex of an adjacent stent hoop. As in the first embodiment, one apex of one stent hoop is disposed between two apexes of an adjacent stent hoop; the generally tubular grafts 204a, 210a, 226a comprise a synthetic material selected from such group consisting of nylon, ePTFE, PTFE, Dacron, and combinations thereof; and preferably, the plurality of stent hoops 204b, 210b, 226b are disposed on the inner surface of the stent graft.

In order to facilitate the incorporation of the fluid flow of the appropriate artery, a first circumferential opening 203 is formed through the graft material 204a of the first portion 202 and around the longitudinal axis of the first portion 202 near the first end 204 so that when the implant 200 When deployed in the abdominal artery, the circumferential opening 203 faces the mesenteric artery.

Likewise, to facilitate blood flow merging of the renal arteries, a second circumferential opening 207 is formed radially around the longitudinal axis of the first portion 202 through the graft material 204a so that when the implant 200 is deployed in the abdominal artery , the circumferential opening 207 faces the renal artery. Likewise, another circumferential opening 211 is formed radially around the longitudinal axis L-L of the second portion 210 through the graft material 204a, 210a for the incorporation of the other renal artery so that when the implant 200 is deployed in the abdominal When in the artery, the circumferential opening 211 faces the other renal artery. Preferably, fenestrations or circumferential openings are provided in the open space between the longitudinally spaced apart sinusoidal stent hoops. It should be noted that the stent hoops are preferably sinusoidal (Figures 1 and 5), but need not be, and thus may be of irregular saw-tooth configuration (Figures 2 and 3). For example, as can be seen in FIGS. 2 and 3 , the stent hoops adjacent to oval openings 209 and 213 (and 309 and 313 ) are irregularly sized serrated stents to allow for a beveled configuration of the openings to be formed.

In order to allow alignment of the circumferential opening with the corresponding artery, in this case the renal artery, the first portion 202 and the second portion 210 can be rotated about the longitudinal axis, as indicated by arrow R1 . That is, the first portion 202 is radially adjustable relative to the second portion 210 (see arrow R1 ), so that the first circumferential opening 107 in the first portion 202 may generally be diametrically opposed to the circumferential opening 211 in the second portion 210 , and a gap G is defined by the intersection of the respective elliptical openings 209 , 213 of the first part 202 and the second part 210 .

Fig. 5 shows an implant 200' which is a modification of the implant 200 of Fig. 2, wherein like reference numerals in Fig. 5 refer to like elements in Fig. 2 . In this variant, we have designed the oval openings 109 and 114 of the respective sections so that they are oriented differently with respect to the circumferential openings 103 and 107 . This illustrates one of the benefits of our design in allowing customization of the implant without a device having to be tediously manufactured by hand.

As mentioned earlier with respect to the first embodiment of FIG. 1 , branch extensions 400a and 400b may be used to allow blood to flow through the first, second and third portions into the branches and branch extensions into the respective iliac arteries . In most cases, the individual circumferential openings (107, 113 in Figure 6) generally form sufficient conduits from the abdominal artery to branch arteries such that a bridging stent is not required. However, there are situations where bridging stent-graft 124 can be utilized to prevent leakage. In this case, a bridging stent-graft 324 may be used to connect the circumferential openings (eg, 211 ) on the graft to the branch arteries (RN1 and RN2) in FIG. 7 .

Referring to Fig. 3, a third modification of the prosthesis of the present invention is shown. In this variation, there is an additional retention mechanism (with barbs 321 ) for the caudal portion 316 of the implant 3000 . In other respects, the structure of implant 300 is substantially the same as that of implant 200 . However, for the sake of completeness, the implant 300 will be described in detail below.

The implant 300 includes a first portion 302 extending along a longitudinal axis L-L. The first portion 302 has a first end 304 that defines a first generally circular opening that is orthogonal relative to the longitudinal axis L-L. A scaffold in the form of a rhomboid shaped bracket is attached to the end, ie the generally circular opening 305 of the first end of the first part. The support frame is provided with retaining barbs 306 extending at an angle relative to the longitudinal axis. The first portion 302 includes a second end defining a generally elliptical opening about the longitudinal axis L-L.

The second portion 310 extends along the longitudinal axis L-L and has a first end 304 that defines a generally elliptical opening 312 relative to the longitudinal axis L-L. The oblong opening 312 allows the second end 308 of the first portion 302 to extend into the generally oblong opening 313 of the second portion 310 . The second portion 310 has a second end 314 defining a second generally circular opening 315 orthogonal to the longitudinal axis L-L. The third portion extends along the longitudinal axis L-L and has a first end 304 defining a generally circular third opening orthogonal to the longitudinal axis L-L to allow the second end of the second portion to move relative to the first end. The three-part first end 304 is nested there. Note that the first end 304 of the third portion has a retaining member 321 coupled to the generally circular third opening 319 via a rhombus-shaped bracket. The third portion 316 has a bifurcation 320 extending into two branches extending along the longitudinal axis L-L.

Each of the first, second, and third portions may include a plurality of stent hoops spaced apart along the longitudinal axis L-L and attached to the graft material to define a stent-graft composite implant. Body 100. Each stent hoop has a generally sinusoidal configuration disposed about a longitudinal axis L-L. The vertices of such stent hoops are spaced apart along the longitudinal axis L-L relative to the vertices of adjacent but individual stent hoops. As used herein, the term "separate" with respect to the stent hoop means that the hoop is not connected with a connector made of the same material as the hoop, but is connected via a different material. To allow for a thin profile prior to deployment, i.e., less than 12 French (implant pre-deployment profiles can be less than 16 French in some cases with larger native arteries), we have designed the stent cuffs as: Example in Figure 1 As shown, one apex of one stent hoop is disposed between two apexes of another stent hoop. The graft material for the tubular portion may be any suitable material, but may generally comprise a synthetic material selected from the group consisting of nylon, ePTFE, PTFE, polyester, and combinations thereof. While the stent hoops can be on the outer surface of the graft to allow the stent hoops to make direct contact with the aorta, we prefer to have the stent hoops placed on the inner surface of the graft or stent-graft material to prevent direct physical contact between the stent hoops and the aorta. touch.

Similar to the first and second embodiments, a first circumferential opening 303 is formed through the graft material around the longitudinal axis of the first portion 302 near the first end 304 so that when the implant is deployed in the abdominal When in the artery, the first circumferential opening 303 faces towards the mesenteric artery. Likewise, a second circumferential opening 307 is formed through the graft material around the longitudinal axis of the first portion 302 so that when the implant is deployed in the abdominal artery, the second circumferential opening 307 faces towards the renal artery , to allow fluid communication from the renal artery to the second circumferential opening 307 . We also designed a third circumferential opening 311 formed through the graft material around the longitudinal axis of the second portion 310 so that when the implant is deployed in the abdominal artery, the third circumferential opening 311 faces towards the other renal artery to allow fluid communication from the renal artery to the third circumferential opening 311 .

By virtue of its construction, the first portion 302 is radially adjustable by R1 relative to the second portion 310 about the longitudinal axis L-L such that the first circumferential opening 303 in the first portion 302 is generally aligned with the first circumferential opening 303 in the second portion. Diametrically opposed and defined by the intersection of respective elliptical openings 309 , 313 of the first part 302 and the second part 310 , a gap G is defined.

As in the previous embodiment, a stent-graft tubular extension 400a, 400b is provided for insertion into each of the two branches to allow fluid to flow from the first opening 305 of the first part 302 through the second and third parts. Portions 302, 310, 316 and flow to respective branches 322, 324 and out through respective extensions 400a, 400b.

It should be noted that while the circumferential opening is shown as a circular opening formed on the circumference of the implant, other shapes and configurations may be utilized within the scope of the present invention. For example, the circumferential opening may be in the shape of a truncated cone that tapers towards a smaller radius as the conical circumferential opening extends away from the longitudinal axis. Alternatively, ridges or retaining ribs may be provided on the circumference of the tapered cone to allow the ribs or ridges to open the tapered cone circumferentially without using the bridging stent graft 424. remain in the inner surface of the branching artery.

The circumferential opening or fenestration may be configured with suture 500 threaded on the circumference of the fenestration 107 (FIG. IB) to provide an initial small opening. The extra length 502 of the suture 500 can be provided at the end of the suture 500 to provide slack built into the suture so that when the opening 107 expands, the slack 502 in the suture allows the fenestration to expand for different diameters. The side branch arteries of the fenestration 107 are matched. The suture 500 may be configured with a predetermined slack length 502 to a lock stitch 504 to prevent overexpansion of the circumferential opening 107 . In addition to the seam 500 , another reinforcement in the form of a seam can also be provided on the circumference of the circumferential opening 107 . Radiopaque markers may be placed on the circumference of the circumferential opening (or interwoven into the suture 500 ), allowing the physician to visualize the actual size of the fenestration 107 . By inserting a suitable inflatable balloon catheter introduced into the fenestration via guidewire GW2, the circumferential opening can be inflated in situ (in the native artery) to the desired size (Fig. 7B). After reaching the fenestration, the airbag may gradually inflate while monitoring via the fenestration markers.

In operational deployment, the surgeon can choose from the different components exemplarily described and shown herein, rather than physically fabricating a custom fenestration on an existing design. Usually the first section is deployed first, forming the basis on which the remaining components are mounted. Thereafter, the second, third or even fourth part may be deployed sequentially, with the branch extension being deployed last. In cases where the AAA is represented as a juxtrenal AAA, the device of Figure 1 or Figure 2 can be utilized and each of the first through third sections individually can be rotated to achieve the desired merging of arteries in the body.

Referring to Fig. 7A, the delivery device 600 is shown in perspective view, with a portion of the handle 602 proximate to the operator, for manipulation by the operator, shown for simplicity. It should be noted that the distal portion 603 is provided with an outer sheath 604 through which the fenestrated tube 606 allows an inner sheath 608 to pass while being introduced by the first guide wire GW1. The fenestrated tube 606 also allows the installation of the implant (either the first part or the second part), so that the circumferential opening of the implant can be fixed to the fenestrated tube 606, so that the rotation of the fenestrated tube 606 allows the movement of the graft implant. The circumferential opening is aligned with the desired branch artery. To illustrate the unique aspects of the fenestrated tube, reference is made to FIG. 7B , which is an enlarged perspective view of the distal end of delivery device 600 .

In FIG. 7B , outer sheath 604 surrounds the outer surface of graft 302 , while the inner surface of graft 302 generally surrounds the outer surface of fenestrated tube or sheath 606 . The fenestrated sheath 606 is generally parallel to the outer surface of the inner sheath 608 that may pass through the outer sheath 604 . To ensure proper alignment of the circumferential opening 307 of the implant 302, the fenestration tube 606 has a fenestration block 612 on which the circumferential opening 307 fits such that the implant is always radially compressed at its pre-delivery position. in silhouette. It should be noted here that while the examples of implants are shown in Figures 1 to 7 in a larger deployed profile (with a concomitant larger external The implant compresses into the sheath 604 to a much smaller constraining profile (which has a smaller outer diameter as small as 14 French or less).

As is known in the art, the stent-graft graft (eg, implant 302 ) is moved to a desired location proximate to the aneurysm by way of the inner sheath 608 followed by the first guidewire GW1 . Once the implant 302 has come close to the desired location, the outer sheath 604 can be pulled back (or the implant pulled out of the sheath 604 ) to expose the fenestration block 612 . This allows the second guidewire GW2 to be pulled out of the block 612 through the lumen provided in the fenestrated tube 606 (or in another lumen built into the inner sheath 608). Under an appropriate guiding technique (eg, fluoroscopy), the second guidewire GW2 is manipulated (via translation or rotation of the fenestrated tube 606 about its longitudinal axis L-L) so that the guidewire GW2 can enter the arterial branch ( For example, in the renal artery RN1 or RN2 in Fig. 6). Insertion of the second guidewire GW2 into the arterial branch will ensure that the circumferential opening (eg, 307 ) is adequately matched to the arterial branch. If desired, a second guidewire may be used to insert the arterial extension or bridging stent. Subsequently, other implant parts (eg, 102, 202, 204, 304, or 310) can be inserted into desired locations along the first guidewire GW1 and deployed so that the other implant parts can be coupled to the first implant part.

Details of the handle and procedure used to deploy a similar AAA graft are shown and described in the instruction manual for the InCraft AAA Implant (available from Europe), which describes an InCraft The AAA stent-graft system is an endovascular stent-graft system for treating infrarenal abdominal aortic aneurysm, and the instructions also describe the specific structure, use and preparation instructions of the InCraft AAA stent-graft system. In the case of exhibiting an AAA other than the infrarenal type, the delivery device for deployment may be via the devices shown and described in US Patent No. US8771333, US Patent Application Publication Nos. US20070156224 and US20130085562, all of which are incorporated by reference incorporated into this article. It is important to note that the examples provided are intended primarily for AAA, such as, for example, in a thoracic aortic aneurysm or TAA where the angle of the artery may make it difficult to form a tight seal between the artery and the graft. Applications utilizing other arterial locations with branched arteries.

All stent hoops described herein are generally tubular elements that can be formed using any number of techniques and from any number of materials. In a preferred exemplary embodiment, all stent hoops are formed from nickel-titanium alloy (Nitinol), shape-setting laser-cut tubing.

The graft material used to cover the stent hoops may be formed from any number of suitable biocompatible materials including braided, knitted, sutured, extruded fabrics formed of polyester, polytetrafluoroethylene, silicone, polyurethane rubber, and ultra-lightweight polyethylene. Pressed or cast materials such as SPECTRADACRONPET type polymers are available under the trade name SPECTRADACRONPET.

As described above, graft material is attached to each stent hoop. The graft material can be attached to the stent hoops in any number of suitable ways. In an exemplary embodiment, the graft material is attached to the stent hoops by sutures.

Depending on the stent hoop position, different types of suture knots can be utilized. Details of various embodiments of suture knots for sutures can be found in US Patent Application Publication No. US20110071614, filed September 24, 2009, which is incorporated herein by reference.

While the invention has been described in terms of certain modifications and drawings shown, it will be understood by those of ordinary skill in the art that the invention is not limited to the described modifications or drawings. For example, while exemplified for AAA, these implants may also be used for barb-retaining thoracic aortic aneurysms (TTAs) which may not require use in TAAs. In addition, where the above methods and steps indicate certain events that occur in a certain order, those skilled in the art should understand that the sequence of certain steps can be modified, and these modifications should be in accordance with the variations of the present invention. Also, certain steps may be performed simultaneously in parallel processes, if possible, as well as sequentially as described above. Therefore, to the extent that the invention variants within the spirit of the disclosure or equivalent to the invention found in the claims, it is intended that the patent covers these variants as well.

Claims (33)

1. An intravascular implant, characterized in that it comprises: a first portion extending along the longitudinal axis, the first portion comprising a generally tubular graft defining a generally circular opening about the longitudinal axis, the first portion comprising a first two ends, the second end defining a generally elliptical opening about the longitudinal axis; and a second portion extending along the longitudinal axis, the second portion having a first end comprising a generally tubular graft defined relative to the longitudinal axis a generally elliptical opening to allow the second end of the first portion to extend into the generally elliptical opening of the second portion, the second portion having a bifurcation, the bifurcation The fork extends into two branches extending along said longitudinal axis. 2. The endovascular implant of claim 1 , wherein each of the first and second portions includes a plurality of stent hoops spaced apart along the longitudinal axis and attached to the graft material to define a stent-graft composite implant, each of said stent hoops having a sinusoidal configuration disposed about said longitudinal axis, wherein apices are spaced apart along said longitudinal axis. 3. The endovascular implant of claim 2, wherein one apex of one stent hoop is disposed between two apexes of the other stent hoop. 4. The intravascular implant of claim 2, wherein said generally tubular graft comprises a synthetic material selected from the group consisting of nylon, ePTFE, PTFE, Dacron and its combination. 5. The endovascular implant of claim 2, wherein the plurality of stent hoops are disposed on an inner surface of the stent graft. 6. The intravascular implant of claim 2, wherein a first circumferential opening is formed through the graft material about the longitudinal axis of the first portion proximate the first end, And thus, when the implant is deployed in the abdominal aorta, the first circumferential opening faces towards the mesenteric artery. 7. The intravascular implant of claim 6, wherein a second circumferential opening is formed through the graft material around the longitudinal axis of the first portion so that when the implant When the implant is deployed in the abdominal artery, the second circumferential opening faces the renal artery. 8. The intravascular implant of claim 7, wherein a first circumferential opening is formed through the graft material about the longitudinal axis of the second portion, whereby, upon implanting the When the body is deployed in the abdominal artery, the first circumferential opening faces the other renal artery. 9. The intravascular implant of claim 8, wherein said first portion is radially adjustable relative to said second portion such that said first circumferential opening in said first portion is generally aligned with The circumferential openings in the second portion are diametrically opposed and a gap is defined by the intersection of the respective elliptical openings of the first and second portions. 10. The intravascular implant according to claim 9, wherein a tubular stent-graft extension is provided for insertion into each of said two branches to allow fluid flow from said first portion to said The first circumferential opening flows through the second portion to the respective branch of the implant and out through each of the extensions. 11. The intravascular implant of claim 6, wherein the first circumferential opening is configured as a first smaller opening and is expandable to a second larger opening. 12. An intravascular implant, characterized in that it comprises: a first portion extending along the longitudinal axis, the first portion having a first end defining a generally circular opening orthogonal to the longitudinal axis, wherein the retaining barb is coupled to the retaining structure, the said retaining structure is connected to said generally circular opening, said first portion includes a second end defining a generally elliptical opening about said longitudinal axis; a second portion extending along the longitudinal axis, the second portion having a first end defining a generally elliptical opening relative to the longitudinal axis to allow the opening of the first portion A second end extends into the generally elliptical opening of the second portion, the second portion having a second end defining a generally circular shape orthogonal to the longitudinal axis. the opening of the a third portion extending along the longitudinal axis, the third portion having a first end defining a generally elliptical opening relative to the longitudinal axis to allow all openings of the second portion said second end is invaginated thereto with respect to said generally elliptical opening of said third portion, said third portion having a bifurcation extending into two branches extending along said longitudinal axis middle. 13. The endovascular implant of claim 12, wherein each of the first portion, the second portion, and the third portion includes a plurality of stent hoops, the plurality of stent hoops spaced apart along the longitudinal axis and attached to the graft material to define a stent-graft composite implant, each of the stent hoops having a sinusoidal configuration disposed about the longitudinal axis with apexes along the The longitudinal axes are spaced apart. 14. The endovascular implant of claim 13, wherein one apex of one stent hoop is disposed between two apexes of the other stent hoop. 15. The intravascular implant of claim 13, wherein said generally tubular graft comprises a synthetic material selected from the group consisting of nylon, ePTFE, PTFE, Dacron and its combination. 16. The endovascular implant of claim 13, wherein the plurality of stent hoops are disposed on an inner surface of the stent graft. 17. The endovascular implant of claim 13, wherein a first circumferential opening is formed through the graft material about the longitudinal axis of the first portion proximate the first end, Thus, when the implant is deployed in the abdominal artery, the circumferential opening faces the mesenteric artery. 18. The endovascular implant of claim 17, wherein a second circumferential opening is formed through the graft material around the longitudinal axis of the first portion so that when the implant When the implant is deployed in the abdominal artery, the circumferential opening faces the renal artery. 19. The intravascular implant of claim 18, wherein another circumferential opening is formed through the graft material around the longitudinal axis of the second portion, whereby when the The implant is deployed in the abdominal artery with the circumferential opening facing the other renal artery. 20. The intravascular implant of claim 19, wherein said first portion is radially adjustable relative to said second portion such that said first circumferential opening in said first portion is generally aligned with The circumferential openings in the second portion are diametrically opposed and a gap is defined by the intersection of the respective elliptical openings of the first and second portions. 21. The intravascular implant according to claim 20, wherein a stent-graft tubular extension is provided for insertion into each of said two branches to allow fluid flow from said first portion to said The first circumferential opening flows through the respective branches of the second and third portions to the implant and out through each of the extensions. 22. An intravascular implant, characterized in that it comprises: a first portion extending along the longitudinal axis, the first portion having a first end defining a first generally circular opening orthogonal to the longitudinal axis, wherein the retaining barb is coupled to the retaining structure , the retaining structure is connected to the generally circular opening, the first portion includes a second end defining a generally elliptical opening about the longitudinal axis; a second portion extending along the longitudinal axis, the second portion having a first end defining a generally elliptical opening relative to the longitudinal axis to allow all of the first portion The second end extends into the generally elliptical opening of the second portion, the second portion having a second end defining a generally circular shape orthogonal to the longitudinal axis. shaped second opening; and a third portion extending along the longitudinal axis, the third portion having a first end defining a generally elliptical third opening orthogonal to the longitudinal axis to allow the first The second end of the second part is nested thereto with respect to the first end of the third part, the first end of the third part has a retaining member coupled to the generally A circular third opening, said third portion having a bifurcation extending into two branches extending along said longitudinal axis. 23. The endovascular implant of claim 22, wherein each of the first portion, the second portion, and the third portion includes a plurality of stent hoops, the plurality of stent hoops spaced apart along the longitudinal axis and attached to the graft material to define a stent-graft composite implant, each of the stent hoops having a sinusoidal configuration disposed about the longitudinal axis with an apex along the longitudinal axis The axes are spaced apart. 24. The endovascular implant of claim 23, wherein an apex of one stent hoop is disposed between two apexes of another stent hoop. 25. The intravascular implant of claim 23, wherein said generally tubular graft comprises a synthetic material selected from the group consisting of nylon, ePTFE, PTFE, Dacron and its combination. 26. The endovascular implant of claim 23, wherein the plurality of stent hoops are disposed on an inner surface of the stent graft. 27. The intravascular implant of claim 23, wherein a first opening is formed through the graft material about the longitudinal axis of the first portion proximate the first end, whereby, The first opening faces the mesenteric artery when the implant is deployed in the abdominal artery. 28. The intravascular implant of claim 27, wherein a second opening is formed through the graft material around the longitudinal axis of the first portion, whereby when the implant When deployed in the abdominal artery, the second opening faces the renal artery to allow fluid communication from the renal artery to the second opening. 29. The intravascular implant of claim 28, wherein a third opening is formed through the graft material around the longitudinal axis of the second portion so that when the implant When the body is deployed in the abdominal artery, the third opening faces the other renal artery to allow fluid communication from the renal artery to the third opening. 30. The intravascular implant of claim 29, wherein the first portion is radially adjustable relative to the second portion such that the first opening in the first portion is generally aligned with the The first openings in the second portion are diametrically opposed and a gap is defined by the intersection of the respective elliptical openings of the first and second portions. 31. The intravascular implant according to claim 30, wherein a stent-graft tubular extension is provided for insertion into each of said two branches to allow fluid flow from said first portion to said The first opening flows through said second and third portions and to the respective branch and out through each of said extensions. 32. A delivery device for deploying an implant in a body artery, the device having a handle portion and a delivery portion distal to the handle, the delivery portion comprising: a first guidewire extending from the delivery section to the handle section; an inner tube in which the first guidewire extends through the inner tube to the handle portion; a fenestration tube generally parallel to the inner tube and configured to be surrounded by at least a portion of the inner surface of the implant, the fenestration tube comprising a fenestration block coupled to a circumferential opening disposed through the inner and outer surfaces of the implant; An outer sheath enclosing at least a portion of an outer surface of the implant thereby constraining the implant to a smaller outer profile than a deployed outer profile. 33. The delivery device of claim 32, further comprising a second guide wire configured to move through a lumen disposed in the fenestration tube into the fenestration block. opening to guide the second guidewire into an arterial branch of the aorta as the fenestrated tube translates and rotates about its longitudinal axis.