Bifurcation-integrated prosthesis system and method

Abstract

Various concepts involve an iliac bifurcation prosthesis extending a length between the proximal and distal ends, which bifurcates from the main flow channel into two flow channels. Various concepts also involve methods for deploying an in-situ prosthesis system to treat aortic aneurysms, including deploying the iliac bifurcation prosthesis into the ipsilateral leg of the bifurcation main prosthesis or into the contralateral opening of the bifurcation main prosthesis.

Description

[0001] Cross-reference related applications

[0002] This application claims priority to U.S. Application No. 18 / 937,795, filed November 5, 2024, claims the benefit of Provisional Application No. 63 / 716,077, filed November 4, 2024, and also claims the benefit of Provisional Application No. 63 / 597,235, filed November 8, 2023, the entire contents of which are incorporated herein by reference for all purposes. Background Technology

[0003] Endovascular devices are used in various parts of the human body to support a variety of anatomical lumens, such as blood vessels, respiratory tracts, and gastrointestinal tracts. These devices are typically deployed at the desired treatment site to treat conditions such as diseases or defects of the aforementioned anatomical lumens, including those affecting the patient's vascular system. Treatment of vascular conditions involving bifurcated lumens is more challenging than treatment of non-bifurcated sites. For example, the abdominal aorta bifurcates into the common iliac artery at its primary branch, which then further bifurcates into the external iliac artery and internal iliac artery (or inferior iliac artery) at their respective secondary branches. Treating such primary and secondary branching anatomy increases surgical complexity due to the addition of modular components and associated delivery systems. For instance, to address more challenging branching anatomy, modular in-body prostheses have been developed, comprising a main in-body prosthesis and one or more branch in-body prostheses that can be assembled in vivo with the main body.

[0004] If the anatomical structure to be treated includes further bifurcation, an in-body prosthesis system including additional modular components can be used. For example, G. Oderich et al., in their article "Technique for Intravascular Aortoiliac Artery Repair Using Iliac Branch In-Body Prostheses" published in the August 2017 issue of Endovascular Treatment Today (Vol. 16, No. 8 Supplement), described the use of bilateral femoral artery access combined with a modular in-body prosthesis system (including the Gore® Excluder® Iliac Branch In-Body Prosthesis) to treat complex multibranched aneurysms.

[0005] The purpose of developing iliac branch devices is to maintain perfusion of the internal iliac artery when a common iliac artery aneurysm requiring isolation is present. Despite their practicality, a large number of patients are excluded from in-label treatment due to the small size of the common iliac artery and / or, depending on the requirements of some iliac branch devices, the excessively short total treatment length from the inferior renal artery to the internal iliac artery. The latter is because a contralateral limb is required to bridge the iliac branch device to the main trunk—an ipsilateral in-situ prosthesis. Summary of the Invention

[0006] Various embodiments relate to in-situ prosthesis systems and methods for delivering bifurcation in-situ prostheses (e.g., iliac bifurcation in-situ prostheses) to patients with short total treatment lengths (multiple). In some examples, the bifurcation in-situ prosthesis can be directly deployed into the contralateral gate of the bifurcation body in-situ prosthesis (e.g., the GORE® EXCLUDER® AAA in-situ prosthesis from Gore Ltd.), thereby eliminating any need for a contralateral limb bridging in-situ prosthesis between the bifurcation in-situ prosthesis and the bifurcation body in-situ prosthesis. Similarly, in some embodiments, the bifurcation in-situ prosthesis can be directly deployed into the ipsilateral limb of the bifurcation body in-situ prosthesis (e.g., the GORE® EXCLUDER® AAA in-situ prosthesis), thereby eliminating any need for a contralateral limb bridging in-situ prosthesis between the bifurcation body in-situ prosthesis when performing bilateral procedures (i.e., procedures that involve bilateral placement of in-situ prostheses in the patient, as associated with AAA system procedures).

[0007] According to one example (“Example 1”), a bifurcation prosthesis extends a length between a proximal and a distal end, branching from a main flow channel into two flow channels. The bifurcation prosthesis includes a main trunk defining the main flow channel at the proximal end; a first leg extending from the main trunk and defining an opening for receiving a branch prosthesis; and a second leg extending from the main trunk to the distal end, the opening and the second leg defining two flow channels, the first leg and the second leg branching from the main trunk in a bifurcation region with a diameter greater than that of the main trunk.

[0008] According to another example (“Example 2”), further, in Example 1, the trunk has a substantially uniform diameter, and optionally, the substantially uniform diameter is about 16 mm.

[0009] According to another example (“Example 3”), further, in Example 1 or 2, the trunk is constructed to be received in the opposite opening of the body-embedded prosthesis.

[0010] According to another example (“Example 4”), further, in any of the aforementioned examples, the length of the trunk is at least 3 centimeters.

[0011] According to another example (“Example 5”), further, in any of the foregoing examples, the first leg defining the opening for receiving the branch-in-place prosthesis is substantially shorter than the second leg, and the opening defined by the first leg optionally defines a diameter of about 8 mm and optionally has a length of about 2.5 cm.

[0012] According to another example (“Example 6”), further, in any of the foregoing examples, wherein the second leg is configured to be anchored in the patient’s external iliac artery, the second leg has a proximal length portion near the bifurcation region, the proximal length portion having a diameter near the bifurcation region that transitions distally to a larger diameter portion near the end of the first leg along the length of the second leg corresponding to the location defining an opening for receiving a branch-in-place prosthesis, the larger diameter portion extending distally.

[0013] According to another example (“Example 7”), further, in Example 1, the first leg defining an opening for receiving a branch-embedded prosthesis includes an end bracket at the distal end of the first leg and a body bracket proximal to the end bracket, the trunk includes one or more brackets, and the second leg includes one or more brackets, and further, wherein the bracket density defined by the end bracket and the body bracket is lower than that of the brackets of the trunk and the second leg.

[0014] According to another example (“Example 8”), further, in any of the foregoing examples, the first leg has a first segment, a second segment, and an intermediate segment extending from the bifurcation region, the first segment having a first diameter that is substantially constant along the first segment, the second segment having a second diameter that is substantially constant along the second segment and is smaller than the first diameter, and the diameter of the intermediate segment tapering between the first segment and the second segment.

[0015] According to another example (“Example 9”), further, in Example 8, the bifurcation built-in prosthesis includes a branch built-in prosthesis received in a complementary mating manner in an opening defined by the first leg, the branch built-in prosthesis engaging with at least a middle segment of the first leg.

[0016] According to another example (“Example 10”), further, in Example 9, the branch-built-in prosthesis is joined with the first segment, the second segment and the intermediate segment.

[0017] According to another example (“Example 11”), further, in any of Examples 8 to 10, the first leg is self-expanding.

[0018] According to another example (“Example 12”), further, in Example 11, the branch-embedded prosthesis is cyst-expandable.

[0019] According to another example (“Example 13”), further, in any of Examples 8 to 12, the first leg defines a retaining shoulder for enhancing the retaining force of the branch-built prosthesis within the first leg.

[0020] According to another example (“Example 14”), a method for deploying an in-situ prosthesis system to treat an aortic aneurysm includes deploying an iliac bifurcation in-situ prosthesis into an opening on the opposite side of the bifurcation body in-situ prosthesis.

[0021] According to another example (“Example 15”), further, in Example 14, the method includes deploying a main in-body prosthesis in the patient’s aorta, and optionally, wherein the main in-body prosthesis is a trunk-ipsilateral abdominal aortic aneurysm (AAA) in-body prosthesis configured for repairing an abdominal aortic aneurysm (AAA).

[0022] According to another example (“Example 16”), further, in Example 14 or 9, the method also includes: inserting a guide wire into a contralateral opening; advancing the iliac bifurcation prosthesis along the guide wire and through an inlet sheath into the contralateral opening; and aligning the iliac bifurcation prosthesis with the contralateral opening using radiopaque markings on the contralateral opening and radiopaque markings on the iliac bifurcation prosthesis.

[0023] According to another example (“Example 17”), further, in any of Examples 14 to 16, the iliac bifurcation in-situ prosthesis is fully extended from the proximal end located within the contralateral opening to the distal end located within the external iliac artery.

[0024] According to another example (“Example 18”), a method for deploying an in-situ prosthesis system to treat an aortic aneurysm includes deploying an iliac bifurcation in-situ prosthesis into the ipsilateral leg of the bifurcation body in-situ prosthesis.

[0025] According to another example (“Example 19”), further, in Example 18, the method also includes: advancing the guide wire through the deployed ipsilateral leg of the body-embedded prosthesis and reversing the guide wire to advance distally and return proximally along the opposite side opening of the body-embedded prosthesis.

[0026] According to another example (“Example 20”), further, in Example 19, advancing the guide wire includes using a tamperable sheath and / or snare to reverse the guide wire.

[0027] According to another example (“Example 21”), further, in Example 20, a reversed guide suture is passed through the patient’s groin and inserted into the internal iliac opening of the iliac bifurcation prosthesis before unfolding the iliac bifurcation in-body prosthesis.

[0028] According to another example (“Example 22”), further, in Example 21, the delivery system for the iliac bifurcation implant is used to advance the iliac bifurcation implant along a guide wire passing through the aorta at the anterior end and along a reverse guide wire passing through the first leg of the unexpanded bifurcation implant.

[0029] According to another example (“Example 23”), further, in Example 21, the reversed guide wire is used as a track guide to advance an appropriately sized inlet sheath upward and over the main body prosthesis from the side opposite to the iliac bifurcation built-in prosthesis and into the internal iliac opening of the iliac branch device, and further, wherein a second guide wire advances via the inlet sheath upward and over the main body and into the internal iliac opening for cannulation of the internal iliac artery.

[0030] According to another example (“Example 24”), further, in Example 23, the internal iliac branch implant is delivered upward and over the main implant through an introductory sheath and into the internal iliac opening of the iliac bifurcation implant and the internal iliac artery, and further, wherein the internal iliac branch implant unfolds in the internal iliac artery and the internal iliac opening of the iliac bifurcation implant.

[0031] According to another example (“Example 25”), a bifurcated in-body prosthesis extending a length between a proximal and distal end branches from a main flow channel into two flow channels, and includes: a trunk defining the main flow channel at the proximal end; a first leg extending from the trunk and defining an opening for receiving the branched in-body prosthesis; and a second leg extending from the trunk to the distal end, the first leg and the second leg defining two flow channels extending from the main flow channel, the first leg and the second leg branching from the trunk in a bifurcation region, the first leg having a first segment, a second segment, and an intermediate segment located between the first segment and the second segment, the first segment having a first diameter that is substantially constant along the first segment, the second segment having a second diameter that is substantially constant along the second segment and is smaller than the first diameter, and the intermediate segment having a diameter that tapers between the first segment and the second segment.

[0032] According to another example (“Example 26”), further, in Example 25, the bifurcation built-in prosthesis also includes a branch built-in prosthesis received in a complementary mating manner in an opening defined by the first leg, the branch built-in prosthesis engaging with at least a middle segment of the first leg.

[0033] According to another example (“Example 27”), further, in Example 26, the branch-built-in prosthesis is joined with the first segment, the second segment and the intermediate segment.

[0034] According to another example (“Example 28”), further, in any of Examples 25 to 27, the first leg is self-expanding.

[0035] According to another example (“Example 29”), further, in Example 28, the branch-embedded prosthesis is cystically expandable.

[0036] According to another example (“Example 30”), further, in any of Examples 25 to 29, the first leg defines a retaining shoulder for enhancing the retaining force of the branch-built prosthesis within the first leg.

[0037] According to another example (“Example 31”), further, in any of Examples 25 to 30, the branch-in-place prosthesis is an internal iliac branch-in-place prosthesis.

[0038] According to another example (“Example 32”), further, in any of Examples 25 to 31, it is constructed as an iliac bifurcation in-body prosthesis.

[0039] According to another example (“Example 33”), a method for deploying an in-situ prosthesis system to treat an aortic aneurysm includes: deploying an iliac bifurcation in-situ prosthesis within an opening on the opposite side of the main in-situ prosthesis; and forming a complementary fit between a retaining shoulder of the first leg of the iliac bifurcation in-situ prosthesis and an internal iliac branch in-situ prosthesis received within the first leg.

[0040] According to another example (“Example 34”), further, in Example 33, the internal iliac branch implant includes a cystic expandable stent, and forming a complementary fit includes cystic expansion of the internal iliac branch implant.

[0041] According to another example (“Example 35”), further, in Example 33 or 34, wherein the first leg has a first segment, a second segment and an intermediate segment located between the first segment and the second segment, the first segment having a first diameter that is substantially constant along the first segment, the second segment having a second diameter that is substantially constant along the second segment and is smaller than the first diameter, and the intermediate segment having a tapering diameter between the first segment and the second segment, wherein the intermediate segment defines a retaining shoulder of the first leg, and forming a complementary engagement includes engaging an internal iliac branch prosthesis with the first segment, the intermediate segment and the second segment.

[0042] The various examples provided in this patent specification should not be construed as limiting or otherwise narrowing the scope of any inventive concept presented in this disclosure. While several examples are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples. Therefore, the drawings and detailed description are to be regarded as illustrative rather than restrictive in nature. Attached Figure Description

[0043] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and, together with the description, serve to explain the principles of the present disclosure.

[0044] Figure 1 A bifurcation built-in prosthesis according to some embodiments is shown.

[0045] Figures 2 to 7 A method for deploying an in-situ prosthesis system in the abdominal aorta, according to some embodiments, is shown.

[0046] Figures 8 to 11 Another deployment method for an in-situ prosthesis system deployed in the abdominal aorta, according to some embodiments, is shown.

[0047] Figures 12A to 14 Additional features of the bifurcation-embedded prosthesis according to some embodiments are shown. Detailed Implementation

[0048] Definitions and Terms

[0049] This disclosure should not be read in a restrictive manner. For example, the terms used in this application should be understood broadly in the context of the meanings that those skilled in the art would assign to them.

[0050] Regarding imprecise terminology, the terms "about" and "approximately" are used interchangeably to refer to measurement results that include the measured value and also any measured value that is reasonably close to the measured value. A measurement result that is reasonably close to the measured value has a reasonably small deviation from the measured value, as understood and readily determined by one of ordinary skill in the art. For example, such deviation may be attributed to measurement errors, differences in the calibration of measuring and / or manufacturing equipment, human error in reading and / or setting the measured value, minor adjustments to performance and / or structural parameters to account for measurement differences related to other components, specific implementation scenarios, imprecise adjustments and / or operations performed on the object by personnel or machines, and / or the like. If the value of such a reasonably small difference is not readily determined by one of ordinary skill in the art, the terms "about" and "approximately" may be understood as plus or minus 10% of the value.

[0051] The methods and apparatuses of various embodiments provided in this description, including the accompanying drawings, can be used in conjunction with vascular treatment methods, such as the treatment of aortic aneurysms (abdominal aortic aneurysms (AAA)). Although specific applications in aortic aneurysms have been described, other treatments using the designs and related methods described herein are also contemplated.

[0052] Branch-in-body prosthesis design

[0053] Figure 1A bifurcation implant 100 (e.g., an iliac bifurcation implant) is illustrated according to some embodiments. The bifurcation implant 100 is formed of one or more graft components and one or more frame or support components. In various examples, the bifurcation implant 100 is designed to be self-expanding, and the bifurcation implant includes one or more self-expanding support components. According to some embodiments, the bifurcation implant 100 may be formed of similar materials and similarly configured to be self-expanding like the GORE® EXCLUDER® iliac branch implant.

[0054] As shown in the figure, the bifurcated prosthesis 100 branches from the main flow channel into two bifurcated flow channels. The bifurcated prosthesis 100 extends a length between the proximal end 102 and the distal end 104. The bifurcated prosthesis 100 includes a main stem 110 defining the main flow channel at the proximal end 102, a first leg 112 extending from the main stem 110, and a second leg 114 extending from the main stem to the distal end 104. These two legs 112 and 114 define the two bifurcated flow channels, and these two legs 112 and 114 bifurcate from the main stem 110 at the bifurcation region 116.

[0055] As shown in the figure, the trunk 110 has a substantially uniform diameter D1 (e.g., approximately 16 mm), although various shapes, sizes, and dimensions can be considered. Typically, the size, shape, and construction of the trunk 110 are designed to accommodate a prosthesis embedded within the body (e.g., Figure 3 Within, for example, the GORE® EXCLUDER® AAA implant. In some embodiments, the trunk 110 is approximately 4 cm long, or at least 3 cm long, to provide sufficient overlap for sealing and connection with the body implant, although various sizes may be considered.

[0056] As shown in the figure, the first leg 112 is substantially shorter than the second leg 114. The first leg serves as an opening or connecting feature for the branch-in-place prosthesis 250 (e.g., an internal iliac branch-in-place prosthesis). The first leg 112 defines a diameter D3 of approximately 8 mm and a length of approximately 1.5 cm in some examples, although various sizes are possible. As described below, in some embodiments ( Figures 12 to 14 The first leg 112 includes a tapered profile that helps to enhance retention. As an example, the first leg 112 may be defined with an initial diameter D0 of 9 mm near the bifurcation region 116 and tapered to a diameter D3 of approximately 7 mm and a length of approximately 2 cm, although various sizes are possible and the foregoing dimensions are not intended to limit all tapered embodiments.

[0057] The second leg 114 may be optionally configured to be placed and anchored in a blood vessel and may serve as an external iliac leg placed and anchored in the external iliac artery. For example, the second leg 114 has a proximal portion near or adjacent to the bifurcation region 116, the portion having a diameter D2 of 10 mm, and may transition distally to a portion having a larger diameter D4, the larger diameter portion being near the end of the first leg 112 and extending to the distal end 104. In some embodiments, D4 is approximately 10 mm, 12 mm, 14.5 mm, or other desired dimensions to facilitate fixation in the external iliac artery. For example, the length of the proximal (smaller diameter) portion of the second leg 114 may be approximately 20 mm, and the length of the distal (larger diameter) portion of the second leg 114 may be approximately 30 mm. For example, the length of the tapering region between the two portions may be approximately 10 mm. While some specific dimensional values ​​are provided, these are provided by way of example and not all embodiments of the second leg 114 should be limited to these example values.

[0058] As shown in the figure, the bifurcation region 116 itself (e.g., a tapering or diameter-increasing portion from the main trunk 110 to the first and second legs 112, 114) may have a larger diameter than the main trunk 110.

[0059] In some embodiments, the stent(s) of the first leg 112 may include an end stent 130 and a body stent 132 located proximal to the end stent 130. As shown, the end stent 130 and body stent 132 may define a relatively lower stent density (e.g., less stent material per unit length) than the stent components of the trunk 110 and the second leg 114. In various examples, a lower stent density in the first leg 112 is sufficient because the branch-in-place prosthesis 250 fixed within the first leg 112 (e.g., an internal iliac branch prosthesis) employs a capsule-expandable (as opposed to self-expanding) design.

[0060] like Figures 12 to 14 As shown, according to some embodiments, some embodiments of the bifurcation-embedded prosthesis 100 can be configured to further enhance or facilitate greater engagement and fixation within the first leg 112, thus requiring less bracing reinforcement for the first leg 112. Specifically, Figures 12 to 14 A bifurcated internal prosthesis 100 is shown, whose first leg 112 has a relative to Figure 1 The design shown is a modified tapered structure. Additionally, the main body 110, the first leg 112, and the second leg 114 each have modified frame patterns, which will be described in more detail below.

[0061] like Figures 12 to 14 As shown, the overall shape of the main trunk 110 is cylindrical, similar to... Figure 1The design of the main trunk 110. The main trunk 110 may have a nominal diameter of approximately 16 mm and a length of approximately 30 mm, although various sizes are possible, and not all embodiments of the main trunk 110 should be limited to these examples. The second leg 114 and... Figure 1 The design is essentially similar, except for the bracket or frame pattern, which will be discussed in more detail below, and will not be described further. The first leg 112 has a relative to Figure 1 The modified overall shape is shown, but similar to the embodiments described above, with the first leg 112 serving as an opening or connecting feature for the branch-in-body prosthesis 250 (e.g., an internal iliac branch-in-body prosthesis). While some specific dimensional values ​​are provided, these are provided as examples and not all embodiments of the trunk 110 should be limited to these example values.

[0062] As shown in the figure, the first leg 112 has a first segment 112a extending from the bifurcation region 116, a second segment 112b generally extending in the direction of the distal end 104, and an intermediate segment 112c located between the first segment 112a and the second segment 112b. The first segment 112a has a first diameter Da that is substantially constant along the first segment 112a. The second segment 112b has a second diameter Db that is substantially constant along the second segment 112b. As shown in the figure, the second diameter Db is smaller than the first diameter Da. The intermediate segment 112c tapers in diameter between the first segment 112a and the second segment 112b. The intermediate segment 112c helps to define the retaining shoulder or retaining feature to enhance the retaining force of the branch-in-body prosthesis 250. Specifically, the branch-embedded prosthesis 250 can be expanded (e.g., cystic expansion) to form a complementary fit with at least the intermediate segment 112c and the second segment 112b, and preferably with the first segment 112a, the second segment 112b and the intermediate segment 112c.

[0063] The first diameter Da of the first segment 112a may be approximately 10%, approximately 20%, approximately 30%, or any value or range between the aforementioned values ​​and the second segment 112. In some embodiments, the first diameter Da of the first segment 112a may be approximately 9 mm. The first diameter Da may be the inner diameter of the first segment 112a. In some embodiments, the second diameter Db of the second segment 112b may be approximately 7 mm. The second diameter Db may be the inner diameter of the second segment 112b. The length of the first leg 112 may be approximately 20 mm. Although some specific dimensional values ​​are provided, these are provided by way of example and not all embodiments of the first leg 112 should be limited to these example values. In some embodiments, the first segment 112a and the second segment 112b are supported by one or more supports, while the intermediate segment 112c is not supported by supports. Although some specific dimensional values ​​are provided, these are provided by way of example and not all embodiments of the first leg 112 should be limited to these example values.

[0064] like Figures 12 to 14 As shown, the main trunk 110 has a support 136 (e.g., a self-expanding spiral-wound support). Figure 12A This is a schematic diagram of the potential winding pattern of the support 136. As shown, the support 136 has a proximal row 136a, a proximal transition row 136b, multiple body rows 136c, a distal transition row 136d, and a distal row 136e. In some examples, the wire diameter of the support 136 is approximately 0.01 inches. Each row of the support 136 may have approximately 7 vertices with a radius of curvature of approximately 0.040 inches, a pitch of approximately 0.18 inches (4.5 mm) between adjacent row vertices, an amplitude of approximately 5 mm, and an interlocking or overlap between rows of approximately 0.6 mm. The distal transition row 136d may be a partial row (e.g., less than a full turn or rotation). As shown, the end rows (the rows closest to the proximal and distal ends) are typically square or perpendicular to the longitudinal axis of the trunk 110. While some specific dimensional values ​​are provided, these are provided as examples and not all embodiments of the trunk 110 should be limited to these example values.

[0065] like Figures 12 to 14 As shown, the first leg 112 has an end bracket 130 (e.g., corresponding to the second segment 112b) and a body bracket 132 (e.g., corresponding to the first segment 112a). Figure 12B This is a schematic diagram showing the unfolded potential winding pattern of the end bracket 130 and the body bracket 132. The wire diameter of the body bracket 132 and the end bracket 130 can be approximately 0.01 inches. As shown, each of the end bracket 130 and the body bracket 132 can have approximately 5 vertices. The amplitude of the end bracket 130 can be approximately 6 mm, and the amplitude of the body bracket 132 can be approximately 12 mm. For example, the vertices of the end bracket 130 and the body bracket 132 can have a radius of curvature of approximately 0.02 inches. In various examples, relatively short bracket struts and overall amplitude (e.g., approximately 50% or less) may result in greater circumferential strength or resistance to expansion of the end bracket 130 and therefore the second segment 112b. In some examples, the end bracket 130 and the body bracket 132 do not overlap or interlock, and there is a gap of approximately 2 mm between them. Although some specific dimensional values ​​are provided, these are provided as examples and not all embodiments of the first leg 112 should be limited to these example values.

[0066] like Figures 12 to 14 As shown, the second leg 114 has a support 142 (e.g., a self-expanding spiral-wound support). Figure 12CThis is a schematic diagram of the potential winding pattern of the support 142, including proximal rows 142a, proximal transition rows 142b, multiple body rows 142c, distal transition rows 142d, and distal rows 142e. In some examples, the wire diameter of the support 142 is approximately 0.01 inches. Each row of the support 136 may have approximately seven vertices, each vertex having a radius of curvature of approximately 0.020 inches, a pitch of approximately 0.18 inches (4.5 mm) between vertices of adjacent rows, and an amplitude of approximately 5 mm. The proximal rows 142a may define an interlock or overlap with the support 144 of the bifurcation region 116. As shown, the proximal transition rows 142b may have at least one vertex defining a substantial interlock (global or complete overlap) with one of the multiple body rows 142a, and each body row 142c may have at least one vertex defining a substantial interlock (global or complete overlap) with an adjacent one of the multiple body rows 142a. The distal transition row 142d can be a partial row (e.g., less than a full circle or turn). For example, the distal body row 142c can interlock with or overlap the distal row 142e by approximately 3 mm. As shown, the end rows corresponding to the proximal row 142a and the distal row 142e (the rows closest to the proximal end and the rows closest to the distal end) are typically square or perpendicular to the longitudinal axis of the second leg 114. Although some specific dimensional values ​​are provided, these are provided as examples and not all embodiments of the second leg 114 should be limited to these example values.

[0067] like Figures 12 to 14 As shown, the bifurcation region 116 has a support 144 (e.g., a self-expanding spiral-wound support or a non-spiral annular support). The wire diameter of the support 144 can be approximately 0.01 inches. For example, the support 144 can have approximately 7 vertices and a single row. While some specific dimensional values ​​are provided, these are provided as examples and not all embodiments of the bifurcation region 116 should be limited to these example values.

[0068] delivery method

[0069] Figures 2 to 7 A method for deploying an in-situ prosthesis system to treat a patient's abdominal aorta A is shown, comprising deploying a bifurcation in-situ prosthesis 100 to a bifurcation body in-situ prosthesis 202. Figure 3 In particular, it extends into the opposite opening 204 of the built-in prosthesis 202 of the bifurcated body.

[0070] like Figure 2 and Figure 3As shown, according to some methods, after preparing the patient according to standard surgical practice (visualization of the guide filament from the initial arterial access to the target vessel), the main body in-situ prosthesis 202 (e.g., trunk-ipsilateral AAA in-situ prosthesis) is deployed to the contralateral opening 204 using the main body delivery system 310. The ipsilateral leg 206 of the main body in-situ prosthesis 202 is then deployed.

[0071] like Figure 4 and Figure 5 As shown, once guided by a wire (e.g., not shown, but optionally in a similar manner), Figure 8 After cannulation of the contralateral opening 204 (as shown in GW1), the bifurcation implant 100 (the iliac bifurcation implant shown) is advanced along the guide suture and into the contralateral opening 204 via the delivery sheath using the iliac bifurcation implant delivery system 320. The guide suture can be reversed or bent, for example, extending upward from the external iliac artery, passing through the ipsilateral leg 206 of the main implant 202, then downward back through the ipsilateral leg 206, and exiting from the contralateral external iliac artery (e.g., again, not shown, but optionally in a manner similar to...). Figure 8 (As shown in GW1). For example, the guide suture can be accessed from two access points on either side of the patient. The guide suture delivery and reversal procedure can be performed according to known methods, including the use of a diverting catheter and / or a guide suture snare. The undeployed bifurcation in-body prosthesis 100, particularly the first leg 112, may be pre-inserted with a removable guide suture cannula to facilitate the introduction of the guide suture through the first leg 112. In some embodiments, the reversible guide suture is passed through the patient's groin and inserted into the pre-inserted first leg 112 of the undeployed bifurcation in-body prosthesis 100 (e.g., as an internal iliac orifice). The bifurcation in-body prosthesis 100 is then advanced along the aortic guide suture passing through the delivery system tip of the iliac bifurcation in-body prosthesis 100 and along the reversible guide suture passing through the first leg 112 of the undeployed bifurcation in-body prosthesis 100. In some methods, a radiopaque marker 208 is used on the contralateral opening 204 of the main body in-body prosthesis 202 ( Figure 4 (An example of which is shown for visualization purposes) Aligns the bifurcation-embedded prosthesis 100 with the main body-embedded prosthesis 202. This marking may be associated with one or more radiopaque markings 108 at the anterior end (e.g., proximal end 102) or other locations on the main trunk 110 (examples are shown in...). Figure 1 and Figure 12 (In the design) Alignment. Then, the bifurcation-integrated prosthesis 100 is fully extended from the proximal end 102 located within the contralateral opening 204 to the distal end 104 located within the external iliac artery EI.

[0072] like Figure 6 and Figure 7As shown, after the delivery system is withdrawn, according to some embodiments, in the guide wire reversal step, the guide wire (not shown) is reversed in one direction within the body-embedded prosthesis 202 from the ipsilateral leg 206 back to the contralateral opening 204, and in a second direction through the first leg 112 (internal iliac opening) of the deployed bifurcated body-embedded prosthesis 100 (e.g., advancing distally and then returning proximally relative to the access point). Various embodiments, as described below, include using a guide wire reversal system (e.g., including a steerable sheath and / or snare) to achieve the reversal of the guide wire. The reversed guide wire is then advanced into the internal iliac artery II. An appropriately sized inlet sheath (e.g., similar to...) is then inserted... Figure 11 The infeeding sheath 600 (shown) is advanced along the reverse guide suture and into the internal iliac artery II. Using a branch delivery system 330 (e.g., an internal iliac branch delivery system), the branch-in-place prosthesis 250 (e.g., an internal iliac branch-in-place prosthesis) is advanced through the infeeding sheath and into the internal iliac artery II. The branch-in-place prosthesis 250 is aligned using appropriate radiopaque markings on the first leg 112 (internal iliac orifice) of the bifurcated infeeding prosthesis 100.

[0073] In some examples (e.g., including the use of, for example) Figure 12 (Examples of the designs shown) The method includes forming a complementary fit between a retaining shoulder defined by a middle section 112c of the first leg 112 of the bifurcated built-in prosthesis 100 and a branch built-in prosthesis 250 received within the first leg 112. The method may include cystic expansion of the branch built-in prosthesis 250 to form the complementary fit such that the branch built-in prosthesis 250 engages with the first leg 112. For example, the branch built-in prosthesis 250 may include a cystic expandable stent (plastically deformable), and forming the complementary fit includes cystic expansion of the branch built-in prosthesis 250 to engage with the first leg (e.g., the retaining shoulder).

[0074] After deploying the branch implant 250 and withdrawing the associated delivery system 330, the proximal end of the branch implant 250 is dilated using an appropriately sized sac within the first leg 112 (internal iliac orifice). Then, the distal end of the branch implant 250 located within the internal iliac artery II is dilated using an appropriately sized sac. The reversed guide suture is then withdrawn from the internal iliac artery II and returned through the first leg 112 (internal iliac orifice) of the bifurcation implant 100. In some methods, the proximal end 102 of the bifurcation implant 100 deployed in the contralateral opening 204 of the main implant 202 and the distal end 104 deployed in the external iliac artery EI are then dilated using the guide suture. Additional steps may be taken according to standard surgical practice.

[0075] Figures 8 to 11Another method for deploying an in-situ prosthesis system to treat a patient’s abdominal aorta A is shown, comprising deploying the bifurcation in-situ prosthesis 100 into the bifurcation body in-situ prosthesis 202, particularly into the ipsilateral outrigger 206 of the bifurcation body in-situ prosthesis 202.

[0076] like Figure 8 As shown, after preparing the patient according to standard surgical practice (e.g., visualization of the guide suture from the initial arterial access to the target vessel), the main in-body prosthesis 202 is deployed to the contralateral opening 204. Once cannulation is performed with the guide suture at the contralateral opening 204, the main in-body prosthesis 202 and the deployed assembly 500 are deployed along one side of the contralateral opening 204. The assembly 500 includes a bifurcation in-body prosthesis 100' (e.g., an iliac bifurcation in-body prosthesis), a branch in-body prosthesis 250' (an internal iliac branch in-body prosthesis), and a contralateral extension in-body prosthesis 400.

[0077] Once the deployed component 500 is in place, guide the wire GW1 (e.g., Figure 8 The guide wire advances through the same-side support leg 206 of the deployed main body prosthesis 202 and reverses direction. In the guide wire reversal step, it advances and returns in one direction within the main body prosthesis 202, then descends in a second direction into the opposite-side opening 204 of the main body prosthesis 202 (e.g., advancing distally and then returning proximally relative to the access point). Various embodiments include using a guide wire reversal system (e.g., including a steerable sheath and / or snare) to achieve guide wire reversal. For ease of reference, the guide wire GW1 is... Figure 8 It is shown in the figure and omitted from the rest of the figures to facilitate observation of the rest.

[0078] The undeployed bifurcation prosthesis 100, particularly the first leg 112, may be pre-inserted with a removable guide suture tube (not shown) to facilitate the introduction of the guide suture GW1 through the first leg 112. In some embodiments, the reversed guide suture is passed through the patient's groin and inserted into the pre-inserted removable guide suture tube in the first leg 112 (internal iliac orifice) of the undeployed bifurcation prosthesis 100. The bifurcation prosthesis 100 is then guided along the aortic guide suture GW2 (e.g., through the delivery system tip of the iliac bifurcation prosthesis 100) to the front of the delivery system. Figure 8 It moves forward and along the reverse guide wire GW1 that passes through the first leg 112 of the unexpanded forked built-in prosthesis 100.

[0079] The bifurcated internal prosthesis 100 is advanced through the inlet sheath and into the ipsilateral leg 206 of the main internal prosthesis 202. Optionally, the bifurcated internal prosthesis 100 is positioned using one or more radiopaque markers on the main internal prosthesis 202, these markers being aligned with radiopaque markers on the front end of the bifurcated internal prosthesis 100. The bifurcated internal prosthesis 100 is then deployed (expanded) in the unfolding direction from the proximal end 102 located within the ipsilateral leg 206 toward the first leg 112 of the bifurcated internal prosthesis 100.

[0080] like Figure 10 As shown, in some embodiments, the reversed guide wire GW1 can be used as a track guide to advance an appropriately sized inlet sheath 600 upward and over the main body prosthesis 202 from the side opposite to the bifurcation inlet prosthesis 100, and into the first leg 112 of the bifurcation inlet prosthesis 100. The second guide wire GW2 is then advanced through the inlet sheath, upward and over the main body 102, and into the first leg 112 for cannulation of the internal iliac artery II.

[0081] The branch implant 250 (internal iliac branch implant) is then delivered upwards and over the main implant 202 via an overpass insertion sheath, into the first leg 112 and the internal iliac artery II. In some embodiments, the branch implant 250 is properly aligned within the first leg 112 using radiopaque markings on the first leg 112 of the bifurcation implant 100. After deploying the branch implant 250 and withdrawing the associated delivery system, the proximal end of the branch implant 250 is enlarged within the first leg 112 using an appropriately sized capsule. Then, the distal end of the branch implant 250 located within the internal iliac artery II is enlarged / expanded using an appropriately sized capsule. The reversed guide filament GW2 is then withdrawn from the internal iliac artery II and returned through the first leg 112 of the bifurcation implant 100. Then, using the guide suture GW1, the cyst catheter is guided to dilate the proximal 102 of the bifurcated in-body prosthesis 100, which extends into the ipsilateral leg 206 of the main in-body prosthesis 202, and the distal 104, which extends into the external iliac artery EI. The procedure is then performed according to standard surgical practice.

[0082] When a bilateral iliac branch device (e.g., two branch-embedded prostheses 100) is required and the total treatment length on the ipsilateral side of the main implanted prosthesis 202's proximal leg 206 is shorter than the length required to accommodate all deployed components, the above combination can be used. Figures 2 to 7 and / or Figures 8 to 11 The method of description. It can be combined with something similar to the above. Figures 2 to 7 or Figures 8 to 11The bifurcation implant 100 is deployed in a manner described. In such an example, the bifurcation implant 100 is deployed before the main implant 202 is fully deployed, while the branch implant 250 (internal iliac branch implant) is delivered upwards and over the bifurcation implant 100. Alternatively, in a manner similar to fusion... Figures 8 to 11 The described method is that after the main built-in prosthesis 202 is fully deployed, the branch built-in prosthesis 250 is delivered upward and across the main built-in prosthesis 202 to deploy the branch built-in prosthesis 100.

[0083] Material

[0084] Materials used for graft components associated with various built-in prostheses can include any material suitable for use as a graft within a selected body cavity. Graft components for various built-in prostheses can be composed of the same or different materials. Graft components can include multiple layers of material, which can be the same or different materials. Graft components can have a layer formed as a tube (innermost tube) and an outermost layer formed as a tube (outermost tube).

[0085] Many graft materials are known, especially those that can be used as vascular grafts. Graft materials can be extruded, coated, or formed from wrapping membranes, or a combination thereof.

[0086] Polymers, biodegradable materials, and natural materials can be used for specific applications. In particular, biocompatible materials for various graft components are considered. In some cases, graft components may include fluoropolymers, such as polytetrafluoroethylene (PTFE) polymers or expanded polytetrafluoroethylene (ePTFE) polymers. In some cases, graft components may be formed from, but are not limited to, polyesters, silicones, polyurethanes, polyethylene terephthalate, or another biocompatible polymer or combinations thereof. In some cases, bioresorbable or bioabsorbable materials, such as bioresorbable or bioabsorbable polymers, may be used. In some cases, the graft may include polyester, polyolefins, carboxymethyl cellulose fabrics, polyurethane, or other woven, nonwoven, or film elastomers.

[0087] Biocompatible materials can be used for various frame or scaffold components associated with the implanted prostheses described herein. For example, nickel-titanium alloy (NiTi) can be used as a material for frames or scaffolds (and any frames discussed herein), but other materials, such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other suitable biocompatible material and combinations thereof, can be used as frame materials. The hyperelasticity and flexibility of NiTi can enhance the conformability of the scaffold. Furthermore, NiTi can be shaped to a desired shape. That is, NiTi can be shaped such that when the frame is unconstrained, such as when the frame is deployed from the delivery system, it tends to self-expand into the desired shape. Self-expanding scaffold component materials and capsule-expandable scaffold component materials are considered.

[0088] The invention described above has been presented in both general and specific terms. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of this disclosure. Therefore, it is intended that the embodiments cover modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. A bifurcated internal prosthesis extending a length between a proximal and a distal end, the bifurcated internal prosthesis branching from a main flow channel into two flow channels, the bifurcated internal prosthesis comprising: The main flow channel is defined at the proximal end; A first leg extends from the main trunk and defines an opening for receiving a branch-embedded prosthesis; as well as The first leg extends from the main trunk to the distal end of the second leg, the opening and the second leg defining the two flow channels, the first leg and the second leg branching from the main trunk in a bifurcation region having a diameter greater than that of the main trunk.

2. The bifurcation-embedded prosthesis according to claim 1, characterized in that, The trunk has a substantially uniform diameter, and optionally, the substantially uniform diameter is about 16 millimeters.

3. The bifurcation-embedded prosthesis according to claim 1 or 2, characterized in that, The main structure is received into the opposite opening of the built-in prosthesis of the main body.

4. The bifurcation-embedded prosthesis according to any one of the preceding claims, characterized in that, The length of the main trunk is at least 3 centimeters.

5. The bifurcation-embedded prosthesis according to any one of the preceding claims, characterized in that, The first leg defining the opening for receiving the branch-in-place prosthesis is substantially shorter than the second leg, and the opening defined by the first leg optionally has a diameter of about 8 mm and optionally has a length of about 2.5 cm.

6. The bifurcation-embedded prosthesis according to any one of the preceding claims, characterized in that, The second leg is constructed to be anchored in the patient's external iliac artery. The second leg has a proximal length portion near the bifurcation region, which has a diameter near the bifurcation region that transitions distally to a larger diameter portion. The larger diameter portion is located near the end of the first leg along the length of the second leg, corresponding to the opening for receiving the branch-in-place prosthesis, and extends distally.

7. The bifurcation-embedded prosthesis according to claim 1, characterized in that, The first leg defining the opening for receiving the branch-in-place prosthesis includes an end bracket at the distal end of the first leg and a body bracket proximal to the end bracket, the trunk includes one or more brackets, and the second leg includes one or more brackets, and further, wherein the bracket density defined by the end bracket and the body bracket is lower than that of the brackets of the trunk and the second leg.

8. The bifurcation-embedded prosthesis according to any one of the preceding claims, characterized in that, The first leg has a first segment, a second segment, and an intermediate segment extending from the bifurcation region, the first segment having a first diameter that is substantially constant along the first segment, the second segment having a second diameter that is substantially constant along the second segment and is smaller than the first diameter, and the diameter of the intermediate segment tapers between the first segment and the second segment.

9. The bifurcation-embedded prosthesis according to claim 8, characterized in that, It also includes the branch-in-place prosthesis received in the opening defined by the first leg in a complementary manner, the branch-in-place prosthesis engaging with at least the middle section of the first leg.

10. The bifurcation-embedded prosthesis according to claim 9, characterized in that, The branch-embedded prosthesis is engaged with the first segment, the second segment, and the intermediate segment.

11. The bifurcation-embedded prosthesis according to any one of claims 8 to 10, characterized in that, The first leg is self-expanding.

12. The bifurcation-embedded prosthesis according to claim 11, characterized in that, The branch-embedded prosthesis is cystically expandable.

13. The bifurcation-embedded prosthesis according to any one of claims 8 to 12, characterized in that, The first leg defines a retaining shoulder for enhancing the retention force of the branch-in-body prosthesis within the first leg.

14. A method for deploying an in-situ prosthesis system to treat an aortic aneurysm, the method comprising: The iliac bifurcation implant is unfolded into the opening on the opposite side of the main iliac bifurcation implant.

15. The method according to claim 14, characterized in that, The method includes deploying the main implant in the patient's aorta, and optionally, the main implant is a trunk-ipsilateral abdominal aortic aneurysm (AAA) implant configured for repairing an abdominal aortic aneurysm (AAA).

16. The method according to claim 14 or 15, characterized in that, Also includes: The opposite opening is described by inserting a guide wire into the conduit; The iliac bifurcation implant is advanced along the guide wire and enters the opposite opening via the inlet sheath; as well as Align the iliac bifurcation prosthesis with the contralateral opening using the radiopaque markings on the contralateral opening and the radiopaque markings on the iliac bifurcation prosthesis.

17. The method according to any one of claims 14 to 16, characterized in that, The iliac bifurcation implant extends fully from its proximal end, located within the contralateral opening, to its distal end, located within the external iliac artery.

18. A method for deploying an in-situ prosthesis system to treat an aortic aneurysm, the method comprising: The iliac bifurcation implant is deployed into the same side of the prosthesis as the main iliac bifurcation implant.

19. The method according to claim 18, characterized in that, Also includes: The guide wire is advanced through the same-side support leg of the unfolded main body prosthesis and then reversed to advance distally and return proximally downward into the opposite opening of the main body prosthesis.

20. The method according to claim 19, characterized in that, Advancing the guide wire includes using a steerable sheath and / or looper to reverse the guide wire.

21. The method according to claim 20, characterized in that, Before deploying the iliac bifurcation implant, the reversed guide suture is passed through the patient's groin and inserted into the internal iliac opening of the iliac bifurcation implant.

22. The method according to claim 21, characterized in that, The delivery system for the iliac bifurcation implant is used to advance the iliac bifurcation implant along a guide wire passing through the anterior end of the aorta and along a reverse guide wire passing through the first leg of the undeployed bifurcation implant.

23. The method according to claim 21, characterized in that, The reversed guide wire serves as a track guide to advance an appropriately sized inlet sheath upward and over the main body prosthesis from the side opposite to the iliac bifurcation inlet prosthesis and into the internal iliac opening of the iliac branch device, and further wherein a second guide wire advances via the inlet sheath upward and over the main body and into the internal iliac opening for cannulation of the internal iliac artery.

24. The method according to claim 23, characterized in that, The internal iliac branch implant is delivered upward through the inlet sheath and across the main implant, and enters the internal iliac opening of the internal iliac bifurcation implant and the internal iliac artery, and further, wherein the internal iliac branch implant unfolds in the internal iliac artery and the internal iliac opening of the internal iliac bifurcation implant.

25. A bifurcated internal prosthesis extending a length between a proximal and a distal end, the bifurcated internal prosthesis branching from a main flow channel into two flow channels, the internal prosthesis comprising: The main flow channel is defined at the proximal end; A first leg extends from the main trunk and defines an opening for receiving a branch-embedded prosthesis; as well as A second leg extending from the main trunk to the distal end, the first leg and the second leg defining the two flow channels extending from the main flow channel, the first leg and the second leg branching from the main trunk at a bifurcation region, the first leg having a first segment, a second segment, and an intermediate segment extending from the bifurcation region, the first segment having a first diameter that is substantially constant along the first segment, the second segment having a second diameter that is substantially constant along the second segment and is smaller than the first diameter, and the diameter of the intermediate segment tapering between the first segment and the second segment.

26. The bifurcation-embedded prosthesis according to claim 25, characterized in that, It also includes the branch-in-place prosthesis received in the opening defined by the first leg in a complementary manner, the branch-in-place prosthesis engaging with at least the middle section of the first leg.

27. The bifurcation-embedded prosthesis according to claim 26, characterized in that, The branch-embedded prosthesis is engaged with the first segment, the second segment, and the intermediate segment.

28. The bifurcation-embedded prosthesis according to any one of claims 25 to 27, characterized in that, The first leg is self-expanding.

29. The bifurcation-embedded prosthesis according to claim 28, characterized in that, The branch-embedded prosthesis is cystically expandable.

30. The bifurcation-embedded prosthesis according to any one of claims 25 to 29, characterized in that, The first leg defines a retaining shoulder for enhancing the retention force of the branch-in-body prosthesis within the first leg.

31. The bifurcation-embedded prosthesis according to any one of claims 25 to 30, characterized in that, The prosthesis in the branch is an internal iliac branch prosthesis.

32. The bifurcation-embedded prosthesis according to any one of claims 25 to 31, characterized in that, The bifurcation-integrated prosthesis is a bifurcation-integrated prosthesis.

33. A method for deploying an in-situ prosthesis system to treat an aortic aneurysm, the method comprising: The iliac bifurcation implant is deployed within the opening on the opposite side of the main implant; A complementary fit is formed between the retaining shoulder of the first leg of the iliac bifurcation implant and the internal iliac branch implant received within the first leg.

34. The method according to claim 33, characterized in that, The internal iliac branch implant includes a cystic expandable stent, and forming the complementary fit includes cystic expansion of the internal iliac branch implant.

35. The method according to claim 33 or 34, characterized in that, The first leg has a first segment, a second segment, and an intermediate segment located between the first segment and the second segment. The first segment has a first diameter that is substantially constant along the first segment. The second segment has a second diameter that is substantially constant along the second segment and is smaller than the first diameter. The intermediate segment tapers in diameter between the first segment and the second segment. The intermediate segment defines the retaining shoulder of the first leg. Forming the complementary engagement includes engaging the internal iliac branch implant with the first segment, the intermediate segment, and the second segment.

Images