Single approach delivery method and system for branch vessel therapy

Abstract

The present disclosure generally relates to methods for delivering an expandable endoluminal prosthetic device through a single access site. More particularly, the present disclosure relates to methods for placing an endoprosthesis to treat the aneurysm general iliac artery.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of Provisional Patent Application No. 63 / 543,373, filed on October 10, 2023, the full text of which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to methods for delivering an embedded prosthesis to a treatment location within a patient's body cavity using a single-access site. More specifically, this disclosure relates to a single-access site delivery method for treating branch vessels, and associated apparatus and systems. Background Technology

[0004] Endovascular devices are used in various locations within the human body to support a variety of anatomical lumens, such as blood vessels, the respiratory tract, and the gastrointestinal tract. These devices are typically deployed at the desired treatment site to treat conditions such as those involving anatomical lumens of the patient's vascular system, as described above. Treatment of vascular conditions involving bifurcated lumens is more challenging than treatment of non-bifurcated sites. For example, the abdominal aorta bifurcates at its main branch into the common iliac artery, which further branches at opposing secondary branches into the external iliac artery and the internal iliac artery (or inferior iliac artery). Treatment of such main and secondary branch anatomy structures increases the complexity of the procedure due to the addition of modular components and associated delivery systems. For instance, to address more challenging branching anatomy structures, 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. In cases where the anatomical structure to be treated includes additional bifurcations, an in-body prosthesis system incorporating additional modular components can be employed. For example, G. Oderich et al., in their article "Techniques of Endovascular Aortoiliac Repair Using an Iliac Branch Endoprosthesis" published in Supplement to Endovasc. Today, Volume 16, Issue 8, August 2017, described the use of a bilateral femoral artery approach combined with a modular in-situ prosthesis system (including the Gore® Excluder® Iliac Branch In-Situ Prosthesis) to treat complex multi-branch aneurysms. Summary of the Invention

[0005] This specification relates to built-in prosthesis delivery systems and methods for delivering built-in prostheses to endovascular treatment sites including branch vessels. These methods can be used to treat a range of diseases in branch vessels, including abdominal aortic aneurysms, common iliac artery aneurysms, external iliac artery aneurysms, and / or internal iliac artery aneurysms. In various embodiments, the delivery systems and methods disclosed herein allow for simplified endovascular implantation procedures suitable for complex target sites, such as those extending through branch vessel anatomy with multiple branching levels. In various examples, these simplified methods include implantation of the built-in prosthesis using a single approach site (e.g., a femoral artery approach site).

[0006] According to a first example (“Example 1”), a method of delivering a device to a target vascular location includes: advancing a primary implantable prosthesis to a location adjacent to a bifurcation of a major blood vessel via an external access point in the patient’s body, the primary implantable prosthesis including a body branching into a first leg and a second leg, wherein the major blood vessel branches into a first branch and a second branch at the bifurcation; deploying the primary implantable prosthesis; advancing a guide reversal system from the external access point through the first branch of the major blood vessel into the first leg of the primary implantable prosthesis; advancing a guide member through the external access point through the first branch of the major blood vessel into the first leg of the primary implantable prosthesis and into the body of the primary implantable prosthesis; guiding the guide member back into the second leg of the primary implantable prosthesis and into the second branch of the major blood vessel using the guide reversal system; advancing an auxiliary implantable prosthesis via the external access point on the guide member and into the second leg of the primary implantable prosthesis; and deploying the auxiliary implantable prosthesis.

[0007] According to another example (“Example 2”) that is further than Example 1, the main vessel is the descending aorta.

[0008] According to another example (“Example 3”) that is further than Example 1 or 2, using a guide reversal system to guide the guide member back into the second leg of the main built-in prosthesis and into the second branch of the main blood vessel includes: guiding the guide member back into the second branch with a steering sheath and / or snagging the guide member with a snare and pulling the guide member back into the second branch with the snare.

[0009] According to another further example (“Example 4”) relative to any of Examples 1 to 3, the auxiliary built-in prosthesis includes a body that branches into a first leg and a second leg.

[0010] According to another further example (“Example 5”) relative to any of Examples 1 to 4, the auxiliary implant is deployed in the first leg of the main implant to connect the main implant and the auxiliary implant.

[0011] According to another further example (“Example 6”) relative to any of Examples 1 to 5, the method further includes: guiding the second guiding member through the external access site and the first branch of the main blood vessel into the second leg of the main implanted prosthesis.

[0012] According to another example (“Example 7”) that is further relative to Example 6, the method further includes: advancing the second auxiliary built-in prosthesis into the second leg of the main built-in prosthesis via an external access portion on the second guide member; and deploying the second auxiliary built-in prosthesis in the second leg of the main built-in prosthesis to connect the second auxiliary built-in prosthesis and the main built-in prosthesis.

[0013] According to another example (“Example 8”) that is further relative to Example 7, the second auxiliary built-in prosthesis includes a body that branches into a first leg and a second leg.

[0014] According to another further example (“Example 9”) relative to any of Examples 1 to 8, the method further includes: using a guide reversal system to guide the guide member back through the first leg of the auxiliary implant to the second leg of the main implant and into the second branch of the main blood vessel; advancing the third auxiliary implant, including the main lumen, into the first leg of the auxiliary implant via an external access site; and deploying the third auxiliary implant in the first leg of the auxiliary implant to connect the auxiliary implant and the third auxiliary implant.

[0015] According to another example (“Example 10”) that is further relative to Example 9, the third auxiliary built-in prosthesis includes a main body cavity without any branches.

[0016] According to another further example (“Example 11”) relative to any of Examples 1 to 10, the method further includes: using a guide reversal system to guide the guide member back through the second leg of the auxiliary implant to the second leg of the main implant and to the second branch of the main blood vessel; advancing the fourth auxiliary implant into the second leg of the auxiliary implant via an external access site on the guide member; and deploying the fourth auxiliary implant in the second leg of the auxiliary implant to connect the auxiliary implant and the fourth auxiliary implant.

[0017] According to another example (“Example 12”) that is further than Example 11, the fourth auxiliary built-in prosthesis includes a main body cavity without any branches.

[0018] According to another example (“Example 13”) that is further than Example 11 or 12 which includes the features of Example 9 or 10, the fourth auxiliary built-in prosthesis is substantially similar to the third auxiliary built-in prosthesis.

[0019] According to another further example (“Example 14”) of any of 9 to 13 relative to Example 7 or 8 or including the features of Example 7 or 8, the method further includes: guiding a guide member through the first leg of the second auxiliary implant back into the first leg of the main implant using a guide reversal system, and guiding it into the first branch of the main blood vessel; advancing a fifth auxiliary implant into the first leg of the second auxiliary implant via an external access site on the guide member; and unfolding the fifth auxiliary implant in the first leg of the second auxiliary implant to connect the second auxiliary implant and the fifth auxiliary implant.

[0020] According to another example (“Example 15”) that is further relative to Example 14, the fifth auxiliary built-in prosthesis includes a main body cavity without any branches.

[0021] According to another further example (“Example 16”) of any of 9 to 15 relative to Example 7 or 8 or including the features of Example 7 or 8, the method further includes: guiding a guide member through the second leg of the second auxiliary implant back into the first leg of the main implant using a guide reversal system, and guiding it into the first branch of the main blood vessel; advancing a sixth auxiliary implant into the second leg of the second auxiliary implant via an external access site on the guide member; and unfolding the sixth auxiliary implant in the second leg of the second auxiliary implant to connect the second auxiliary implant and the sixth auxiliary implant.

[0022] According to another example (“Example 17”) that is further relative to Example 16, the sixth auxiliary built-in prosthesis includes a main cavity.

[0023] According to another example (“Example 18”), a delivery system for delivering a device to a target vascular location via a single external access site includes: a primary implantable prosthesis configured to be implanted via an external access site in the patient’s body at a location adjacent to a first branch and a second branch of a major vascular vessel, the primary implantable prosthesis including a body branching into a first leg and a second leg; a guide member capable of advancing via the external access site through the first branch of the major vascular vessel into the first leg of the primary implantable prosthesis and into the body of the primary implantable prosthesis; a guide reversal system capable of advancing from the external access site through the first branch of the major vascular vessel into the first leg of the primary implantable prosthesis and configured to guide the guide member back into the second leg of the primary implantable prosthesis and into the second branch of the major vascular vessel; and an auxiliary implantable prosthesis capable of advancing via the external access site over the guide member into the second leg of the primary implantable prosthesis.

[0024] According to another example (“Example 19”) that is further relative to Example 18, the main built-in prosthesis is configured to be implanted into the descending aorta via an external access site.

[0025] According to another example (“Example 20”) that is further relative to Example 18 or 19, the system also includes a steering sheath and / or snare configured to guide the guiding member back into the second leg of the main built-in prosthesis and into the second branch of the main blood vessel.

[0026] According to another further example (“Example 21”) relative to any of Examples 18 to 20, the auxiliary built-in prosthesis includes a body that branches into a first leg and a second leg.

[0027] According to another further example (“Example 22”) relative to any of Examples 18 to 21, the auxiliary implant can be deployed through an external access site into the first leg of the main implant to connect the main implant and the auxiliary implant.

[0028] According to another further example (“Example 23”) relative to any of Examples 18 to 22, the system also includes a second guiding member capable of being guided through the external access site and the first branch of the main blood vessel into the second leg of the main implanted prosthesis.

[0029] According to another example (“Example 24”) that is further relative to Example 23, the system also includes a second auxiliary built-in prosthesis that is capable of advancing through an external access portion on a second guide member into a second leg of a main built-in prosthesis and is capable of unfolding in the second leg of the main built-in prosthesis to connect the second auxiliary built-in prosthesis and the main built-in prosthesis.

[0030] According to another example (“Example 25”) that is further relative to Example 24, the second auxiliary built-in prosthesis includes a body that branches into a first leg and a second leg.

[0031] According to another further example (“Example 26”) relative to any of Examples 18 to 25, the system also includes a third auxiliary built-in prosthesis that can be guided on a guide member via an external access portion into a first leg of the auxiliary built-in prosthesis and deployed in the first leg of the auxiliary built-in prosthesis to connect the auxiliary built-in prosthesis and the third auxiliary built-in prosthesis.

[0032] According to another example (“Example 27”) that is further relative to Example 26, the third auxiliary built-in prosthesis includes a main body cavity without any branches.

[0033] According to another further example (“Example 28”) relative to any of Examples 18 to 27, the system also includes a fourth auxiliary built-in prosthesis that can be guided on the guide member via an external access portion into the second leg of the auxiliary built-in prosthesis and can be deployed in the second leg of the auxiliary built-in prosthesis to connect the auxiliary built-in prosthesis and the fourth auxiliary built-in prosthesis.

[0034] According to another example (“Example 29”) that is further relative to Example 28, the fourth auxiliary built-in prosthesis includes a main body cavity without any branches.

[0035] According to another example (“Example 30”) that is further than Example 28 or 29 which includes the features of Example 26 or 27, the fourth auxiliary built-in prosthesis and the third auxiliary built-in prosthesis are substantially similar.

[0036] According to another further example (“Example 31”) relative to any of Examples 24 to 25, the system also includes a fifth auxiliary built-in prosthesis that is capable of advancing on the guide member via an external access portion into the first leg of the second auxiliary built-in prosthesis and is capable of unfolding in the first leg of the second auxiliary built-in prosthesis to connect the second auxiliary built-in prosthesis and the fifth auxiliary built-in prosthesis.

[0037] According to another example (“Example 32”) that is further relative to Example 31, the fifth auxiliary built-in prosthesis includes a main body cavity without any branches.

[0038] According to another further example (“Example 33”) relative to any of Examples 24 to 25, the system also includes a sixth auxiliary built-in prosthesis that is capable of advancing on the guide member via an external access portion into the second leg of the second auxiliary built-in prosthesis and is capable of unfolding in the second leg of the second auxiliary built-in prosthesis to connect the second auxiliary built-in prosthesis and the sixth auxiliary built-in prosthesis.

[0039] According to another example (“Example 34”) that is further relative to Example 33, the sixth auxiliary built-in prosthesis includes a main cavity.

[0040] According to another example (“Example 35”), a delivery system for delivering a device to a target vascular location via a single external access site includes: a main delivery system for advancing a primary implantable prosthesis to a location adjacent to a bifurcation of a major blood vessel via an external access site in the patient’s body, and for deploying the primary implantable prosthesis, the primary implantable prosthesis including a body branching into a first leg and a second leg, wherein the major blood vessel branches into a first branch and a second branch at the bifurcation. The system also includes a guidance reversal system capable of advancing from the external access site through the first branch of the major blood vessel into the first leg of the primary implantable prosthesis, and a guide member capable of advancing through the external access site through the first branch of the major blood vessel into the first leg of the primary implantable prosthesis and into the body of the primary implantable prosthesis, such that the guide member can be guided back to the second leg of the primary implantable prosthesis and into the second branch of the major blood vessel using the guidance reversal system. The system also includes an auxiliary delivery system for advancing an auxiliary implantable prosthesis via the external access site onto the guide member into the second leg of the primary implantable prosthesis and deploying the auxiliary implantable prosthesis.

[0041] According to another example (“Example 36”) that is further relative to Example 35, the main vessel is the descending aorta.

[0042] According to another example (“Example 37”) that is further than Example 35 or 36, the guide reversal system is configured to guide the guide member back into the second leg of the main implant and into the second branch of the main vessel by turning the guide member back into the second branch using a steering sheath. In some further examples, the system optionally includes a snare for snagging the guide member with the snare and pulling the guide member back into the second branch with the snare.

[0043] According to another further example (“Example 38”) relative to any of Examples 35 to 37, the auxiliary built-in prosthesis includes a body that branches into a first leg and a second leg.

[0044] According to another further example (“Example 39”) relative to any of Examples 35 to 38, the auxiliary built-in prosthesis can be deployed in the first leg of the main built-in prosthesis by an auxiliary delivery system to connect the main built-in prosthesis and the auxiliary built-in prosthesis.

[0045] According to another further example (“Example 40”) relative to any of Examples 35 to 39, the system also includes a second guiding member capable of being guided through the external access site and the first branch of the main blood vessel into the second leg of the main implanted prosthesis.

[0046] According to another example (“Example 41”) that is further relative to Example 40, the system includes a second auxiliary built-in prosthesis that is capable of advancing through an external access portion on a second guide member into a second leg of a main built-in prosthesis, and is capable of unfolding in the second leg of the main built-in prosthesis to connect the second auxiliary built-in prosthesis and the main built-in prosthesis.

[0047] According to another example (“Example 42”) that is further relative to Example 7, the second auxiliary built-in prosthesis includes a body that branches into a first leg and a second leg.

[0048] According to another further example (“Example 43”) relative to any of Examples 35 to 42, the guiding member can be guided back to the second leg of the main implantable prosthesis via the first leg of the auxiliary implantable prosthesis using a guiding reversal system, and guided into the second branch of the main blood vessel. Furthermore, the system includes a third auxiliary implantable prosthesis, which includes a main lumen and is capable of advancing over the guiding member into the first leg of the auxiliary implantable prosthesis via an external access site. The system includes a third auxiliary prosthesis delivery system configured to deploy the third auxiliary prosthesis within the first leg of the auxiliary implantable prosthesis to connect the auxiliary implantable prosthesis and the third auxiliary implantable prosthesis.

[0049] According to another example (“Example 44”) that is further relative to Example 43, the third auxiliary built-in prosthesis includes a main body cavity without any branches.

[0050] According to another further example (“Example 45”) relative to any of Examples 35 to 44, the guiding member can be guided back to the second leg of the main implantable prosthesis via the second leg of the auxiliary implantable prosthesis using a guiding reversal system and guided to the second branch of the main blood vessel. The system also includes a fourth auxiliary implantable prosthesis delivery system configured to advance a fourth auxiliary implantable prosthesis into the second leg of the auxiliary implantable prosthesis via an external access site on the guiding member. The fourth auxiliary implantable prosthesis can be deployed in the second leg of the auxiliary implantable prosthesis to connect the auxiliary implantable prosthesis and the fourth auxiliary implantable prosthesis.

[0051] According to another example (“Example 46”) that is further relative to Example 45, the fourth auxiliary built-in prosthesis includes a main body cavity without any branches.

[0052] According to another further example (“Example 47”) relative to Example 45 or 46 which are dependent on claims 43 or 44, the fourth auxiliary built-in prosthesis is substantially similar to the third auxiliary built-in prosthesis.

[0053] According to another further example (“Example 48”) relative to (i) Example 41 or 42, or any of (ii) Examples 43 to 47 which are subordinate to Example 41 or 42, wherein the guiding member can be guided back to the first leg of the main implant using a guiding reversal system via the first leg of the second auxiliary implant and guided to the first branch of the main blood vessel, the system also includes a fifth auxiliary implant delivery system configured to advance the fifth auxiliary implant into the first leg of the second auxiliary implant via an external access site on the guiding member and unfold the fifth auxiliary implant in the first leg of the second auxiliary implant to connect the second auxiliary implant and the fifth auxiliary implant.

[0054] According to another example (“Example 49”) that is further relative to Example 48, the fifth auxiliary built-in prosthesis includes a main body cavity without any branches.

[0055] According to another further example (“Example 50”) relative to (i) Example 41 or 42, or any one of (ii) Examples 43 to 49 which are subordinate to Example 41 or 42, wherein the guiding member can be guided back to the first leg of the main implant using a guiding reversal system via the second leg of the second auxiliary implant and guided to the first branch of the main blood vessel, and the system further includes a sixth auxiliary implant delivery system configured to advance the sixth auxiliary implant into the second leg of the second auxiliary implant via an external access site on the guiding member and unfold the sixth auxiliary implant in the second leg of the second auxiliary implant to connect the second auxiliary implant and the sixth auxiliary implant.

[0056] According to another example (“Example 51”) that is further relative to Example 50, the sixth auxiliary built-in prosthesis includes a main cavity.

[0057] The various embodiments should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by this disclosure. While numerous examples have been 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 should be considered illustrative in nature and not restrictive. Attached Figure Description

[0058] The accompanying drawings are included to provide a further understanding of this disclosure, and are incorporated in and form a part of this specification, illustrating embodiments and serving, together with the specification, to explain the principles of this disclosure. The drawings are not necessarily drawn to scale, but may be enlarged to illustrate various aspects of this disclosure, and in this respect, the drawings should not be construed as limiting.

[0059] Figures 1-20 Various features associated with systems and methods for deploying an embedded prosthesis into a branch vascular system using a single (e.g., unilateral) approach point are shown.

[0060] Figure 1 High-level process diagrams are provided related to a method for implanting a multi-branch built-in prosthesis system using a single access point, according to some embodiments.

[0061] Figure 2 A method is illustrated according to some embodiments, including introducing a guiding member into a patient P's vascular system from an access site S.

[0062] Figure 3 A primary built-in prosthesis system according to some embodiments is shown, which includes a primary built-in prosthesis and a primary delivery system, the primary built-in prosthesis being associated with the primary delivery system for delivery to a desired location.

[0063] Figure 4 A main built-in prosthesis according to some embodiments is shown, which includes a body branching into a first leg and a second leg.

[0064] Figure 5 A first assistive implant system according to some embodiments is shown, which includes a first assistive implant and a first assistive delivery system, the first assistive implant being associated with the first assistive delivery system for delivery to a desired implantation site.

[0065] Figure 6 A second built-in prosthesis according to some embodiments is shown, which is deployed such that the distal end of the second built-in prosthesis expands into the second leg of the main built-in prosthesis.

[0066] Figure 7 A second assistive built-in prosthesis system according to some embodiments is shown, which includes a second assistive built-in prosthesis and a second assistive delivery system.

[0067] Figure 8 A second auxiliary implant prosthesis according to some embodiments is shown, which is deployed such that the distal end of the second auxiliary implant prosthesis expands into the first leg of the main implant prosthesis.

[0068] Figure 9 A guided reversal system according to some embodiments is shown, which advances along a first guide member within a first branch of the main blood vessel into the first leg of the main implanted prosthesis.

[0069] Figure 10 A guided reversal system according to some embodiments is shown, which guides a first guiding member into the second leg of the main implant, into the second branch of the main blood vessel, and into the first leg of the first auxiliary implant.

[0070] Figure 11 A third assistive built-in prosthesis system according to some embodiments is shown, which is moved into place on a first guide member and inserted into the first leg of a first assistive built-in prosthesis.

[0071] Figure 12 A third auxiliary implant prosthesis according to some embodiments is shown, which is deployed such that the distal end of the third auxiliary implant prosthesis extends into the first leg of the first auxiliary implant prosthesis.

[0072] Figure 13 A first guide member according to some embodiments is shown, which is fully withdrawn from the third auxiliary built-in prosthesis and partially withdrawn from the first auxiliary built-in prosthesis.

[0073] Figure 14 A first guide member according to some embodiments is shown, which is fully withdrawn from the fourth auxiliary implant and from the first auxiliary implant, and guided back into the first leg of the main implant and the first leg of the second auxiliary implant.

[0074] Figure 15 A fifth assistive implant, according to some embodiments, is shown, which advances along a first guide member into the first leg of a second assistive implant.

[0075] Figure 16 A first guide member is shown that is completely withdrawn from a fourth auxiliary implant and from a second auxiliary implant, according to some embodiments.

[0076] Figure 17 A sixth assistive built-in prosthesis system according to some embodiments is shown, which is moved into place on a first guide member and inserted into the second leg of a second assistive built-in prosthesis.

[0077] Figure 18 A guide reversal system according to some embodiments is shown, which includes a snare operable to capture the distal portion of a first guide member.

[0078] Figure 19 According to some embodiments, a retracted snare is shown, in which air guides a first guiding member into the first leg of the main internal prosthesis.

[0079] Figure 20 A guide sheath of a guide reversal system according to some embodiments is shown, which advances along a first guide member, within a first branch of the main blood vessel, into the first leg of the main implanted prosthesis, and guides the first guide member along a desired path. Detailed Implementation

[0080] This disclosure is not intended to be interpreted in a restrictive manner. For example, the terms used in the application should be interpreted broadly within the context in which those skilled in the art would assign meaning to such terms.

[0081] Regarding imprecise terminology, the terms "about" and "approximately" are used interchangeably to refer to a measurement that includes the measured value and also includes any measured value reasonably close to the measured value. A measured value reasonably close to the measured value deviates from the measured value by a reasonably small amount, as understood and readily determined by one of ordinary skill in the art. Such deviations can be attributed to, for example, measurement errors, differences in the measurement value and / or manufacturing device calibration, human error in reading and / or setting the measurement value, fine-tuning to optimize performance and / or structural parameters taking into account differences in measurement values ​​related to other components, specific implementation scenarios, imprecise adjustments and / or manipulations of the object by humans or machines, and / or the like. If it is determined that 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" can be understood to mean plus or minus 10% of the value.

[0082] Figure 1 High-level process diagrams are provided related to a method for implanting a multi-branched in-body prosthesis system using a single access point, according to some embodiments. As shown, the method typically includes, in a single-access guided delivery step 1002, obtaining access to the patient's vascular system from a single access point (e.g., the femoral artery) using an endovascular device guide (e.g., a guide filament). A primary in-body prosthesis, such as a branch body in-body prosthesis (e.g., the GORE® EXCLUDER® AAA in-body prosthesis), is delivered from the single access point into the patient's vascular system (e.g., within the suprenal aorta and / or inferrenal aorta) in a primary in-body prosthesis delivery step 1012.

[0083] As described below, one or more additional guides can be introduced into the vascular system from the approach point for delivering one or more additional built-in prostheses into the vascular system for coupling with the primary built-in prosthesis. According to some embodiments, as part of the overall method, in guide reversal step 1022, at least one guide is reversed in direction to pass through the primary built-in prosthesis in one direction and return through the primary built-in prosthesis in a second direction (e.g., in a distal direction, and then in a proximal direction defined relative to the approach point).

[0084] As described below, various embodiments include the use of a guided reversal system (e.g., including a steerable sheath, such as the bidirectional steerable guided sheath sold by Oscor Inc. under the trade name "DESTINO") and / or a snare (e.g., the intravascular snare system sold by Merit Medical under the trade name "EN SNARE") to reverse the guide as part of guided reversal step 1022. One or more auxiliary in-situ prostheses (e.g., the GORE® EXCLUDER® iliac branch in-situ prosthesis) are delivered from a single approach point using an associated delivery system introduced over the reversed guide and through the main in-situ prosthesis to treat one or more branch vessels (e.g., the common iliac artery, internal iliac artery, and / or external iliac artery).

[0085] Figures 2 to 20 Features of a multi-level branch built-in prosthesis (MLBE) system and associated delivery methods according to various examples are illustrated. As shown, the MLBE system includes a guide member 10 ( Figure 1 ), second guide component 20 ( Figure 6 ), main built-in prosthesis system 30 ( Figure 3 ), First auxiliary built-in prosthesis system 40a ( Figure 5 ) and the second auxiliary built-in prosthesis system 40b ( Figure 7 ), Third auxiliary built-in prosthesis system 50a ( Figure 11 The system includes a fourth auxiliary built-in prosthesis system (not shown, optionally substantially similar to system 50a), a fifth auxiliary built-in prosthesis system (not shown, optionally substantially similar to system 50a), and a sixth auxiliary built-in prosthesis system (not shown, optionally substantially similar to system 50a), and a guidance reversal system 70. Figure 10 As shown in the figure, the MLBE system can be used to treat a site or region of the vascular system that spans multiple branching levels, such as the extension shown through the aorta “A” (e.g., the subrenal aorta), the first branching level of the aorta at (one or more) common iliac arteries “CI”, and the second branching level at (one or more) internal iliac arteries “II” and (one or more) external iliac arteries “EI”.

[0086] The primary guiding member 10 and the second guiding member 20 are optionally guiding wires or similar flexible members, along which suitable in-body prosthesis delivery systems and similar endovascular devices can be traced through the vascular system of the patient P. Figure 2 ).

[0087] like Figure 3As shown, the primary implant system 30 includes a primary implant 32 and a primary implant delivery system 34, the primary implant 32 being associated with the primary implant delivery system 34 for delivery to the desired location. In some embodiments, the primary implant system is a GORE® EXCLUDER® AAA implant, including appropriate delivery accessories (e.g., an introduction sheath and other components). Figure 4 As shown, the main internal prosthesis 32 includes a main body 320 that branches into a first leg 322 and a second leg 324. Figure 3 As shown, the main implantable prosthesis 32 can be prepared for implantation and associated in a compact state with the main implantable prosthesis delivery system 34 (e.g., a delivery catheter). The main implantable prosthesis 32 can then be deployed from the main implantable prosthesis delivery system 34 such that the main implantable prosthesis 32 expands into the main vessel (e.g., the aorta A), which bifurcates into a first branch and a second branch (e.g., the common iliac artery CI).

[0088] Similarly, such as Figure 5 As shown, the first assistive implantable prosthesis system 40a includes a first assistive implantable prosthesis 42a and a first assistive delivery system 44a, the first assistive implantable prosthesis 42a being associated with the first assistive delivery system 44a for delivery to the desired implantation site. As shown, the first assistive implantable prosthesis 42a has a bifurcated configuration, having a body 420 branching into a first leg 422 and a second leg 424. Similar to the main implantable prosthesis 32, the first assistive implantable prosthesis 42a is prepared for implantation outside the patient. For example, the first assistive implantable prosthesis 42a may be configured in a compact state and carried by the first assistive delivery system 44a (e.g., a delivery catheter). The first assistive implantable prosthesis 42a may subsequently unfold from the first assistive delivery system 44a, such that the first assistive implantable prosthesis 42a expands into a first branch vessel (e.g., the common iliac artery CI), the first branch vessel further bifurcating into additional branch vessels (e.g., the internal and external iliac arteries on the patient's P side).

[0089] like Figure 7 As shown, the second auxiliary in-body prosthesis system 40b includes a second auxiliary in-body prosthesis 42b and a second auxiliary delivery system 44b. The first auxiliary in-body prosthesis 42a and the second auxiliary in-body prosthesis 42b, along with the associated delivery system, may be substantially similar (e.g., identical, mirror images of each other, or otherwise substantially similar). In some embodiments, the first auxiliary in-body prosthesis system 40a and the second auxiliary in-body prosthesis system 40b are similar to the GORE® EXCLUDER® iliac branch in-body prosthesis system, including in-body prostheses with different or substantially the same leg length (e.g., as shown), and including appropriate delivery attachments.

[0090] like Figure 11 As shown, the third assistive implant system 50a includes a third assistive implant 52a and a third assistive delivery system 54a, wherein the third assistive implant 52a is associated with the third assistive delivery system 54a to deliver it to the desired implantation site. Similarly, the fourth, fifth, and sixth assistive implant systems include a fourth assistive implant 52b, a fifth assistive implant 52c, and a sixth assistive implant 52d, respectively. Figure 17 The third to sixth auxiliary in-situ prostheses, and their associated delivery systems (not shown), are optionally substantially similar and are therefore optionally described cumulatively by the features of the third auxiliary in-situ prosthesis 50a. In some embodiments, the third to sixth auxiliary in-situ prostheses 50a, 50b, 50c, and 50d are configured to resemble the internal iliac artery component of the GORE® EXCLUDER® iliac branch in-situ prosthesis system, with legs of different or equal lengths as required. One or more of the third to sixth auxiliary in-situ prostheses may be configured to resemble the GORE® VBX stent graft, the GORE® VIABAHN® device, the GORE® EXCLUDER® AAA in-situ prosthesis component, the GORE® EXCLUDER® iliac branch in-situ prosthesis component, etc. As shown, the third auxiliary in-situ prosthesis 52a, the fourth auxiliary in-situ prosthesis 52b, the fifth auxiliary in-situ prosthesis 52c, and the sixth auxiliary in-situ prosthesis 52d each optionally have a body and are unbranched, or define a single lumen.

[0091] Figures 9 to 15 The features and usage of guided reversal systems, based on various examples, are illustrated. As shown, guided reversal systems assist in guiding multi-branched built-in prostheses to a target location within a patient's body. Guided reversal systems are particularly suitable for navigating tortuous anatomical structures, such as vascular system regions spanning multiple branch levels. Guided reversal systems may include a steerable sheath that can be actuated using one or a combination of several actuation mechanisms to bend through curves, such as tendon actuation mechanisms, magnetic navigation mechanisms, or soft material actuation mechanisms (e.g., shape memory effect, conductive polymer actuation mechanisms, and hydraulic actuation mechanisms).

[0092] like Figure 2 As shown, the method includes introducing the guide member 10 into the vascular system of the patient P from the access site S. The access site S can be a unilateral access site (on one side of the patient P), such as one of the femoral arteries leading to one of the corresponding external iliac arteries (EI).

[0093] like Figure 3As shown, the method also includes delivering the main in-body prosthesis system 30, particularly the main in-body prosthesis 32, through an external access site S in the patient's body to a location adjacent to the bifurcation of the main vessel (e.g., into the bifurcation of the aorta A adjacent to the common iliac artery CI) on the guide member 10 (or otherwise using the guide member 10 as a guide).

[0094] like Figure 4 As shown, once positioned as needed, the primary implant 32 is dilated (partially or completely) into the vascular system near the first branch level (e.g., adjacent to the common iliac artery CI). The primary implant 32 can be dilated by active dilation (e.g., applying dilation force to the primary implant 32 using a balloon deployment system) or self-dilation (e.g., dilation upon release from the primary implant delivery system 34) or a combination thereof.

[0095] Similarly, as Figure 4 As shown, the second guiding member (e.g., the second guiding wire) 20 is guided through the external access site S, through the first branch of the main blood vessel (e.g., through the external iliac artery and the common iliac artery), and into the second leg 324, exiting from the body 320 of the main implant 32. Furthermore, as shown, according to some embodiments, after the main implant 32 is partially or fully deployed and the main implant delivery system 34 is removed, the guiding member 10 remains in place, extending through the first leg 322 and the body 320 of the main implant 32.

[0096] like Figure 5 As shown, the first auxiliary implant system 40a is moved into place on the second guide member 20 and enters the second leg 324. The second implant 120 advances along the second guide member 20, within the first branch 102 of the main blood vessel, and into the second leg 118 of the main implant. Figure 6 As shown, the second internal prosthesis 120 is deployed such that its distal end expands into the second leg 118 of the main internal prosthesis. The second guide member 110 is then fully retracted. Although it is shown that the second auxiliary internal prosthesis 42b is deployed next, it should be understood that in other embodiments, the third auxiliary internal prosthesis 52a and the fourth auxiliary internal prosthesis 52b are deployed first (e.g., using the methods described in association with those components).

[0097] refer to Figure 7 The second auxiliary implantable prosthesis system 40b is moved into place on the guide member 10 and enters the first leg 322 of the main implantable prosthesis 32. The second auxiliary implantable prosthesis 42b advances along the guide member 10, advances within the first branch 102 of the main blood vessel, and advances into the first leg 322 of the main implantable prosthesis 32. Figure 8As shown, the second auxiliary implant 42b is deployed, such that the distal end of the second auxiliary implant 42b expands into the first leg 322 of the main implant 32.

[0098] refer to Figure 9 The guide reversal system 70 (e.g., including a steerable sheath 72) advances along the guide member 10 within the first branch 102 of the main blood vessel into the first leg 322 of the main implanted prosthesis 32. Figure 10 As shown, the guide reversal system 70 guides the first guide member into the second leg 118 of the main implant 32, within the second branch 104 of the main blood vessel, and into the first leg 422 of the first auxiliary implant 42a.

[0099] refer to Figure 11 The third auxiliary implant system 50a is moved into place on the guide member 10 and enters the first leg 422 of the first auxiliary implant 42a. The third auxiliary implant 52a advances along the guide member 10 into the first leg 422 of the first auxiliary implant 42a. Figure 12 As shown, the third auxiliary implant 52a is deployed, such that the distal end of the third auxiliary implant 52a expands into the first leg 422 of the first auxiliary implant 42a.

[0100] refer to Figure 13 The guide member 10 is completely withdrawn from the third auxiliary implant 52a and partially withdrawn from the first auxiliary implant 42a. The guide reversal system 70 guides the guide member 10 into the second leg 424 of the first auxiliary implant 42a. The fourth auxiliary implant system 50b is moved into place on the guide member 10 and enters the second leg 424 of the first auxiliary implant 42a. The fourth auxiliary implant 52b advances along the guide member 10 into the second leg 424 of the first auxiliary implant 42a. The fourth auxiliary implant 52b is deployed such that the distal end of the fourth auxiliary implant 52b expands into the second leg 424 of the first auxiliary implant 42a.

[0101] refer to Figure 14 The guide member 10 is completely withdrawn from the fourth auxiliary implant 52b and from the first auxiliary implant 42a. The guide reversal system 70 guides the guide member 10 back into the first leg 322 of the main implant 32, and then into the first leg 402 of the second auxiliary implant 42b. As shown, the guide reversal system 70 is positioned above the bifurcation in the main implant 32 to assist in cannulation of the first leg 322 with the guide member 10. The fifth auxiliary implant system 50c is moved into place on the guide member 10 and enters the first leg 402 of the second auxiliary implant 42b. Figure 15As shown, the fifth auxiliary implant 52c advances along the guide member 10 into the first leg 402 of the second auxiliary implant 42b. The fifth auxiliary implant 52c is deployed such that the distal end of the fifth auxiliary implant 52c expands into the first leg 402 of the second auxiliary implant 42b.

[0102] refer to Figure 16 The guide member 10 is completely withdrawn from the fourth auxiliary internal prosthesis 52b and from the second auxiliary internal prosthesis 42b. (As...) Figure 17 As shown, the sixth assistive implant system 50d is moved into place on the guide member 10 and enters the second leg 404 of the second assistive implant 42b. The sixth assistive implant 52d advances along the guide member 10 into the second leg 404 of the second assistive implant 42b. The sixth assistive implant 52d is deployed such that the distal end of the sixth assistive implant 52d expands into the second leg 404 of the second assistive implant 42b. The sixth assistive delivery system (not shown) can then be withdrawn from the patient P's body along with the guide member 10.

[0103] like Figure 19 As shown, the guide reversal system 70 may include various additional or alternative features of the aforementioned steerable sheath 72. As shown, the guide reversal system 70a includes a snare 210 operable to capture the distal portion of the guide member 10, such as... Figure 18 As shown. Specifically, the snare 210 can be guided from a single-entry point through the second leg 324 of the main built-in prosthesis 32. The guide member 10 and the snare 210 can be manipulated such that the guide member 10 is captured in the end of the snare 210. As... Figure 19 As shown, the snare 210 is withdrawn, guiding the guide member 10 into the first leg 322 of the main built-in prosthesis 32. The delivery method can then be carried out in a similar manner to that previously described with respect to the steerable sheath 72.

[0104] Figure 20 A guide sleeve 70b is shown, which can be flexible and trackable without the aid of any steering mechanism (e.g., having an offset at its distal end toward a curved or bow-shaped form). Figure 20 As shown, the guide sheath 70b of the guide reversal system 70a can advance along the guide member 10, within the first branch 102 of the main blood vessel, and into the second leg 324 of the main implanted prosthesis 32. The guide reversal system 70a can then be used in conjunction with the above. Figures 6-17 The guide member 10 is guided in a similar manner to allow the first to sixth auxiliary built-in prosthesis systems 40a, 40b, 50a, 50b, 50c, 50d to advance along the guide member 10 as previously described. For example, except... Figure 20Outside the position of the guide member 10 shown in the diagram, as indicated by the dashed line, the guide sleeve 70b can be used with... Figures 14 to 17 The delivery step shown is associated with guiding the guide member 10 back into the first leg 322 of the main implant 32. As shown, the guide sheath 70b is positioned above or beyond the branch or bifurcation in the main implant 32 to facilitate reintubation of the first leg 322 with the guide member 10 and return to the common iliac artery via the guide member 10.

[0105] It should be understood that although certain methods and apparatuses are described below, other methods or apparatuses that are determined to be suitable by a person skilled in the art may be used instead.

[0106] Biocompatible materials may be used for the graft components discussed herein. In some cases, the graft may comprise a fluoropolymer, such as polytetrafluoroethylene (PTFE) polymer or expanded polytetrafluoroethylene (ePTFE) polymer. In some cases, the graft may be formed of, for example, but not limited to, polyester, silicone, urethane, polyethylene terephthalate, or another biocompatible polymer or combinations thereof. In some cases, bioresorbable or bioabsorbable materials may be used, such as bioresorbable polymers or bioabsorbable polymers. In some cases, the graft may comprise polyester, polyolefin, carboxymethyl cellulose fabric, polyurethane or other woven, nonwoven, or (thin) film elastomers.

[0107] The frame or scaffold used in any implanted prosthesis described herein, and therefore the implanted prosthesis itself, may be configured to be self-expanding, expandable (e.g., balloon expandable), or a combination thereof. Various scaffold or frame materials are envisioned, including NiTi, which can be used as a material for the frame or scaffold (and any frame discussed herein), but other materials such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy nonmagnetic alloys, or any other suitable biocompatible materials 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, the frame tends to self-expand into the desired shape.

[0108] The invention of this application has been described above with general reference to specific embodiments. 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, the embodiments are intended to cover modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. A method for delivering a device to a target blood vessel location, the method comprising: The main implant is advanced to the bifurcation of the main blood vessel via an external access site in the patient's body. The main implant includes a main body that branches into a first leg and a second leg, wherein the main blood vessel branches into a first branch and a second branch at the bifurcation. Expand the main internal prosthesis; The guide reversal system is advanced from the external access site through the first branch of the main blood vessel into the first leg of the main implant; The guide member is advanced through the first branch of the main blood vessel via the external access site into the first leg of the main implant and into the body of the main implant; The guiding reversal system is used to guide the guiding member back into the second leg of the main implant and into the second branch of the main blood vessel; The auxiliary implant is advanced into the second leg of the main implant via the external access point on the guide member; and Expand the aforementioned auxiliary built-in prosthesis.

2. The method according to claim 1, characterized in that, The main blood vessel mentioned is the descending aorta.

3. The method according to claim 1 or 2, characterized in that, Using the guide reversal system to guide the guide member back into the second leg of the main built-in prosthesis and into the second branch of the main blood vessel includes: (i) turning the guide member back into the second branch with a steering sleeve and / or (ii) locating the guide member with a snare and pulling the guide member back into the second branch with the snare.

4. The method according to any one of claims 1 to 3, characterized in that, The auxiliary built-in prosthesis includes a main body that branches into a first leg and a second leg.

5. The method according to any one of claims 1 to 4, characterized in that, The auxiliary implant is deployed within the first leg of the main implant to connect the main implant and the auxiliary implant.

6. The method according to any one of claims 1 to 5, characterized in that, Also includes: The second guiding member is guided through the external access site and the first branch of the main blood vessel into the second leg of the main implant.

7. The method according to claim 6, characterized in that, Also includes: The second auxiliary implant prosthesis is advanced into the second leg of the main implant prosthesis via the external access point on the second guide member; as well as The second auxiliary implant is deployed into the second leg of the main implant to connect the second auxiliary implant and the main implant.

8. The method according to claim 7, characterized in that, The second auxiliary built-in prosthesis includes a main body that branches into a first leg and a second leg.

9. The method according to any one of claims 1 to 8, characterized in that, Also includes: The guiding reversal system is used to guide the guiding member through the first leg of the auxiliary implant back to the second leg of the main implant, and then to the second branch of the main blood vessel; Through the external access portion, the third auxiliary implantable prosthesis, including the main cavity, is advanced onto the first leg portion of the auxiliary implantable prosthesis via the guide member; as well as The third auxiliary implant is deployed into the first leg of the auxiliary implant to connect the auxiliary implant and the third auxiliary implant.

10. The method according to claim 9, characterized in that, The third auxiliary built-in prosthesis includes a main cavity without any branches.

11. The method according to any one of claims 1 to 10, characterized in that, Also includes: The guiding reversal system is used to guide the guiding member back through the second leg of the auxiliary implant to the second leg of the main implant, and then to the second branch of the main blood vessel; The fourth auxiliary implant prosthesis is advanced into the second leg of the auxiliary implant prosthesis via the external access point on the guide member; as well as The fourth auxiliary implant is deployed into the second leg of the auxiliary implant to connect the auxiliary implant and the fourth auxiliary implant.

12. The method according to claim 11, characterized in that, The fourth auxiliary built-in prosthesis includes a main cavity without any branches.

13. The method according to claim 11 or 12, which is dependent on claim 9 or 10, characterized in that, The fourth auxiliary implant is substantially similar to the third auxiliary implant.

14. The method according to claim 7 or 8, or any one of claims 9 to 13, wherein, Also includes: The guiding reversal system is used to guide the guiding member back through the first leg of the second auxiliary implant to the first leg of the main implant, and then to the first branch of the main blood vessel; The fifth auxiliary implant prosthesis is advanced into the first leg of the second auxiliary implant prosthesis via the external access point on the guide member; as well as The fifth auxiliary implant is deployed within the first leg of the second auxiliary implant to connect the second auxiliary implant and the fifth auxiliary implant.

15. The method according to claim 14, characterized in that, The fifth auxiliary implant includes a main cavity without any branches.

16. The method according to claim 7 or 8, or any one of claims 9 to 15, wherein, Also includes: The guiding reversal system is used to guide the guiding member back through the second leg of the second auxiliary implant to the first leg of the main implant, and then to the first branch of the main blood vessel; The sixth auxiliary implant prosthesis is advanced into the second leg of the second auxiliary implant prosthesis via the external access point on the guide member; as well as The sixth auxiliary implant is deployed within the second leg of the second auxiliary implant to connect the second auxiliary implant and the sixth auxiliary implant.

17. The method according to claim 16, characterized in that, The sixth auxiliary built-in prosthesis includes a main cavity.

18. A delivery system for delivering a device to a target vascular location via a single external access site, the system comprising: The main implant is configured to be inserted into the bifurcation of a major blood vessel into a first branch and a second branch via an external access site in the patient's body. The main implant includes a main body that branches into a first leg and a second leg. A guiding member, which can advance through the external access point via the first branch of the main blood vessel into the first leg of the main implant and into the body of the main implant; A guidance reversal system is configured to advance from the external access site through the first branch of the main blood vessel into the first leg of the main implant, and to guide the guiding member back into the second leg of the main implant and into the second branch of the main blood vessel; as well as An auxiliary internal prosthesis is capable of advancing through the external access portion onto the guide member into the second leg of the main internal prosthesis.

19. The system according to claim 18, characterized in that, The main built-in prosthesis is configured to be implanted into the descending aorta through the external access site.

20. The system according to claim 18 or 19, characterized in that, It also includes a steering sleeve and / or a snare configured to guide the guiding member back into the second leg of the main implant and into the second branch of the main blood vessel.

21. The system according to any one of claims 18 to 20, characterized in that, The auxiliary built-in prosthesis includes a main body that branches into a first leg and a second leg.

22. The system according to any one of claims 18 to 21, characterized in that, The auxiliary implant can be deployed through the external access portion into the first leg of the main implant to connect the main implant and the auxiliary implant.

23. The system according to any one of claims 18 to 22, characterized in that, It also includes a second guiding member that can be guided through the external access site and the first branch of the main blood vessel into the second leg of the main implant.

24. The system according to claim 23, characterized in that, It also includes a second auxiliary implant, which is capable of advancing through the external access portion on the second guide member into the second leg of the main implant, and is capable of unfolding in the second leg of the main implant to connect the second auxiliary implant and the main implant.

25. The system according to claim 24, characterized in that, The second auxiliary built-in prosthesis includes a main body that branches into a first leg and a second leg.

26. The system according to any one of claims 18 to 25, characterized in that, It also includes a third auxiliary implant, which can be guided through the external access portion onto the guide member into the first leg of the auxiliary implant, and unfolded into the first leg of the auxiliary implant to connect the auxiliary implant and the third auxiliary implant.

27. The system according to claim 26, characterized in that, The third auxiliary built-in prosthesis includes a main cavity without any branches.

28. The system according to any one of claims 18 to 27, characterized in that, It also includes a fourth auxiliary implant, which can be guided through the external access portion onto the guide member into the second leg of the auxiliary implant, and can be deployed into the second leg of the auxiliary implant to connect the auxiliary implant and the fourth auxiliary implant.

29. The system according to claim 28, characterized in that, The fourth auxiliary built-in prosthesis includes a main cavity without any branches.

30. The system according to claim 28 or 29, which is dependent on claim 26 or 27, is characterized in that, The fourth auxiliary implant is substantially similar to the third auxiliary implant.

31. The system according to claim 24 or 25, characterized in that, It also includes a fifth auxiliary implant, which can advance through the external access portion onto the guide member into the first leg of the second auxiliary implant, and can unfold within the first leg of the second auxiliary implant to connect the second auxiliary implant and the fifth auxiliary implant.

32. The system according to claim 31, characterized in that, The fifth auxiliary implant includes a main cavity without any branches.

33. The system according to claim 24 or 25, characterized in that, It also includes a sixth auxiliary internal prosthesis, which can advance through the external access portion onto the guide member into the second leg of the second auxiliary internal prosthesis, and can unfold in the second leg of the second auxiliary internal prosthesis to connect the second auxiliary internal prosthesis and the sixth auxiliary internal prosthesis.

34. The system according to claim 33, characterized in that, The sixth auxiliary built-in prosthesis includes a main cavity.

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