Aortic prosthesis delivery devices and methods of use

Abstract

The hub is slidable along the straight track and the introducer sheath is secured to the hub and extends distally from the hub. The proximal handle is slidable longitudinally along the straight track and defines a helical track having a length of travel along the longitudinal axis. The hub and proximal handle interlock and rotation of the handle about the hub causes longitudinal movement of the hub and retraction of the introducer sheath from the prosthesis which is radially constrained within the introducer sheath. The hub is slidable proximally with the straight track such that at least one of movement of the hub along the helical track and proximal longitudinal movement of the proximal handle along the straight track during rotation of the proximal handle about the longitudinal axis allows retraction of the introducer sheath from the prosthesis.

Description

[Technical field]

[0001] REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 186,954, filed May 11, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] 2. Background of the Invention Arterial pathologies such as aortic aneurysms are often treated with open surgical reconstruction or, alternatively, endovascular repair, which is minimally invasive instead of open surgical repair. However, optimizing the successful outcome of endovascular repair requires evaluation of the patient's anatomy. In the case of an aortic or, more specifically, thoracic or abdominal aortic aneurysm, a suitable prosthesis spanning the proximal and distal ends of the aneurysm ensures complete exclusion of the aneurysm sack by properly securing the prosthesis to the aorta to minimize endoleaks and migration of the prosthesis within the aorta. Given the typically close quarters in which surgeons must operate, devices ancillary to the endovascular delivery of the aortic prosthesis can be cumbersome, especially if they occupy a large amount of space and are not easily manipulated during the precise orientation of the prosthesis required before it is released at the designated placement site across the aneurysm, which is often the case.

[0003] Therefore, a need exists for new and improved endovascular repair devices and methods for treating aortic pathologies, such as aortic aneurysms. Summary of the Invention

[0004] Summary of the Invention The present invention relates to an aortic prosthesis delivery system and methods of use thereof in the treatment and repair of aortic vascular injuries such as aortic aneurysms and vascular injuries associated with the aortic vital territories having arterial branches that supply blood to vital organs and tissues, e.g., thoracic aortic aneurysms, abdominal aortic aneurysms, and thoracic-abdominal aortic aneurysms; and more specifically, juxtarenal aortic aneurysms and short-neck abdominal aortic aneurysms using fenestrated endovascular aortic repair.

[0005] In one aspect, the aortic prosthesis delivery system of the invention includes a distal handle, a straight track extending along a longitudinal axis between a proximal end at a distal end of the distal handle, a hub on and movable along the straight track, and an introducer sheath secured to and extending distally from the hub, the introducer sheath extending distally from the distal handle. A proximal handle proximal to the distal handle is longitudinally slidable along the straight track. The proximal handle defines a helical track having a length of travel along the longitudinal axis of the hub and rotatable about the longitudinal axis. The hub and proximal handle are interlocked such that rotation of the proximal handle about the hub causes longitudinal movement of the hub along the length of the straight track relative to the longitudinal axis and the proximal handle, while the proximal handle remains fixed relative to the distal handle. The length of travel of the hub is limited by the length of the helical track of the hub. The hub and introducer sheath are longitudinally movable along a straight track by at least one of application of a longitudinal force directly to the proximal handle and rotation of the proximal handle about the longitudinal axis.

[0006] In another aspect, the invention relates to a method of delivering an aortic prosthesis, such as a stent graft, to a surgical site. In this aspect, an aortic prosthesis radially constrained within a distal end of an introducer sheath through an artery to an aortic aneurysm of a patient is delivered to the aortic aneurysm of the patient, where the distal end of the introducer sheath is proximal to the aneurysm. A proximal handle proximal to and adjacent the distal handle is rotated, where the proximal handle engages a hub in a helical track defined by an inner surface of the proximal handle, and the hub is fixed to the proximal end of the introducer sheath, whereby the hub is rotated to move proximally along a straight track extending within the proximal handle and distally from the distal handle adjacent the proximal handle, whereby the introducer sheath is at least partially retracted from the aortic prosthesis at the aortic aneurysm and at least partially released from radial constraint by the introducer sheath.

[0007] The present invention has many advantages. For example, the length of the handle of the delivery device is minimized by limiting the length of travel of the hub that the introducer sheath extends distally. More specifically, when the proximal and distal handles are adjacent to each other, the length of travel of the hub that the introducer sheath extends distally can be limited to the length of the proximal handle. Furthermore, by defining a helical track along which the hub can move within the proximal handle, rotation of the proximal handle about the longitudinal axis allows for movement of the hub along a straight track within the proximal handle, or alternatively retraction of the proximal handle proximally along a straight track. Thus, the hub can be moved proximally, thereby retracting the introducer sheath from the aortic prosthesis contained within the introducer sheath without extending the length of the delivery device beyond the cumulative longitudinal length of the proximal and distal handles, so long as the proximal and distal handles are adjacent to each other. This can be important during orientation of the aortic prosthesis at the surgical site and prior to complete release of the aortic prosthesis. Additionally, retraction of the introducer sheath during orientation of the prosthesis becomes more precise with rotation of the proximal handle, which applies leverage and therefore greater control over retraction of the introducer sheath. Concurrently or alternatively, the surgeon has the option of simply moving the proximal handle in a proximal direction along a straight track toward the surgeon, thereby further retracting the hub along the straight track and the introducer sheath more directly away from the surgical site. Only when the proximal handle is oriented proximally along a straight track toward the surgeon does the overall longitudinal dimension of the delivery device increase longitudinally beyond the cumulative longitudinal dimensions of the proximal and distal handles. [Brief description of the drawings]

[0008] BRIEF DESCRIPTION OF THE DRAWINGS The foregoing will be apparent from the following more particular description of illustrative embodiments, as illustrated in the accompanying drawings, in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily made to scale, emphasis instead being placed on illustrating the embodiments. [Figure 1] FIG. 1 is a prospective view of one embodiment of an aortic prosthesis delivery system of the present invention prior to retraction of an introducer sheath and thereby release of a prosthesis radially constrained by the introducer sheath. [Diagram 2] FIG. 2 is a cross-sectional perspective view of the proximal and distal handle portions of the aortic prosthesis delivery system of the present invention at the starting site shown in FIG. 1, prior to retraction of the introducer sheath from the prosthesis constrained by and within the introducer sheath. [Diagram 3] FIG. 3 is a perspective view of the aortic prosthesis delivery system of the invention shown in FIG. 2 following rotation of the proximal handle components, thereby retracting the introducer sheath from the prosthesis. [Figure 4] FIG. 4 is a perspective cross-sectional view of the embodiment shown in FIG. 3 following retraction of the introducer sheath from the prosthesis. [Diagram 5] 5 is a perspective cross-sectional view of the proximal and distal handles of FIG. 2 following proximal movement of the hub along a straight track by application of a longitudinal force directly to the proximal handle without rotation of the proximal handle. [Figure 6] 6 is a perspective cross-sectional view of the aortic prosthesis delivery system of the invention shown in FIG. 1 after retraction of the introducer sheath by application of a longitudinal force directly to the proximal handle without rotation of the proximal handle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Detailed Description of the Invention The features and other details of the invention, either as steps of the invention or as combinations of parts of the invention, are more particularly described and pointed out in the claims. It is understood that the specific embodiments of the invention are shown by way of illustration and not by way of limitation of the invention. The principal features of the invention can be employed in various embodiments without departing from the scope of the invention. It is also understood that the same numbers appearing in different drawings refer to the same items.

[0010] The present invention relates generally to an aortic prosthesis delivery system and methods of use for delivering vascular prostheses in the treatment and repair of vascular injuries, such as those associated with aortic aneurysms, such as pararenal aortic aneurysms and short neck abdominal aortic aneurysms, which include regions of the aorta having arterial branches that supply blood to vital organs and tissues.

[0011] A description of exemplary embodiments follows.

[0012] When referring to a stent graft, also referred to herein as a "prosthesis," "stent graft prosthesis" or "vascular prosthesis," that is delivered or implanted into a patient, the word "proximal" means that a portion of the prosthesis or a component of the prosthesis is relatively close to the patient's heart, and "distal" means that a portion of the prosthesis or a component of the prosthesis is relatively far away from the patient's heart.

[0013] However, when referring to a delivery system or a component of a delivery system used to deliver or implant a prosthesis, the word "proximal" as used herein means closer to the clinician using the delivery system. When referring to a delivery system or a component of a delivery system, "distal" as the term is used herein means further away from the clinician using the delivery system.

[0014] For clarity, the word "proximal" means "near" as distinct from the meanings ascribed to "proximal" or "distal" above with respect to either the prosthesis or the delivery system.

[0015] One embodiment of an aortic prosthesis delivery system of the present invention is shown in Figure 1. As shown therein, the aortic prosthesis delivery system 10 includes a proximal handle 12 having a proximal end 14 and a distal end 16, and a distal handle 18 having a proximal end 20 and a distal end 22. An introducer sheath 24 has a proximal end 26 and a distal end 28 and extends distally from the distal end 22 of the distal handle 18 to which it is attached. A prosthesis, not shown, is radially retracted within the distal end 28 of the introducer sheath 24. A guidewire catheter 32 extends through the proximal handle 12, the distal handle 18 and the introducer sheath 24.

[0016] There are two ways in which the introducer sheath 24 may be retracted from the prosthesis to expose it, thereby releasing it from radial constriction. Figure 2 is a perspective cross-sectional view of one embodiment of the proximal portion of the aortic prosthesis delivery system 10 shown in Figure 1 in a starting position prior to deployment of the prosthesis. As shown in Figure 2, the proximal and distal handles 12, 18 are in adjacent relationship to one another, and the prosthesis, not shown, is radially constricted within the distal end 28 of the introducer sheath 24, but extends circumferentially around the guidewire catheter 32.

[0017] As can be seen in FIG. 2, the distal handle 18 has a proximal end 20 and a distal end 22. The proximal end 20 and the distal end 22 define a longitudinal axis 34. A straight track 36 extends proximally from the distal handle 12 and along the longitudinal axis 34. A hub 38 is on the straight track 36 and is slidable along the straight track 36. A lip 40 is on the hub 38. The introducer sheath 24 is secured to the hub 38 and extends distally therefrom. The length of longitudinal movement of the hub 38 along the longitudinal axis 34 is limited by the length of the straight track 36. The movement of the hub 38 is also limited to movement along a helical track 42 of the proximal handle 12. The introducer sheath 24 extends distally from the distal handle 18. The proximal handle 12 is proximal to the distal handle 18 and is slidable longitudinally along the straight track 36. An inner surface 44 of the proximal handle 12 defines a helical track 42 having a length of longitudinal travel along the longitudinal axis 34. The proximal handle 12 is rotatable about the longitudinal axis 34. The proximal handle 12 and hub 38 interlock, such that rotation of the proximal handle 12 about the hub 38 moves the hub 38 longitudinally along the length of the longitudinal axis 34 and the straight track 36 relative to the proximal handle 12, while the proximal handle 12 remains longitudinally fixed relative to the distal handle 18. As shown in FIG. 2, a lip 40 of the hub 38 fits into the helical track 42 of the proximal handle 12, thereby moving the hub 38 along the straight track 36 as a result of rotation of the proximal handle 12 about the longitudinal axis 34.

[0018] 3 is a perspective cross-sectional view of the proximal handle 12 and distal handle 18 of the aortic prosthesis delivery system 10 shown in FIGS. 1 and 2 after retraction of the introducer sheath 24 ( FIG. 4 ) from a prosthesis 46 having a proximal end 30 and a distal end 50 by rotation of the proximal handle 12 ( FIG. 3 ) about a longitudinal axis 34, with the proximal handle 12 in adjacent relationship to the distal handle 18. In one embodiment of a method of use of the aortic prosthesis delivery system 10 of the present invention shown in the transition from FIG. 2 to FIG. 3 , rotation of the proximal handle 12 relative to the hub 42 and straight track 36 moves the edge 40 of the hub 38 along the helical track 42 of the proximal handle 12. As a result, depending on the direction of rotation of the proximal handle 12, the hub 38 moves proximally along the straight track 36. The introducer sheath 24 is fixed to the hub 38 so that proximal movement of the hub 38 along the straight track 36 by rotation of the proximal handle 12 causes retraction of the introducer sheath 24 and resulting exposure of the prosthesis 46, as seen in FIG.

[0019] Alternatively, the introducer sheath 24 may be retracted from the prosthesis 46 without rotating the proximal handle 12 about the longitudinal axis 34 by applying a direct longitudinal force in the proximal direction 48 relative to the proximal handle 12. In this embodiment of the method of using the aortic vascular delivery system 10 of the present invention, the hub 38 may be moved proximally along the straight track 36, thereby retracting the introducer sheath 24 from the prosthesis 46 by applying a direct longitudinal force along the straight track 36 in the proximal direction 48 relative to the proximal handle 12, toward the surgeon. As can be seen specifically in the transition from FIG. 3 to FIG. 5, the proximal handle 12 moves away from the distal handle 18, thereby moving the distal end 16 of the proximal handle 12 away from the proximal end 20 of the distal handle 18. In this embodiment, longitudinal separation of the proximal handle 12 from the distal handle 18 causes retraction of the introducer sheath 24 from the prosthesis 46 and release of the prosthesis 46 from radial constriction by the introducer sheath 24, as can be seen in FIG.

[0020] There are various embodiments of methods of use of the present invention to implant a prosthesis, such as prosthesis 46, at a vascular site. First, the proximal handle 12 and the distal handle 18 can be manipulated to orient the introducer sheath 24, which at the distal end 28 of the introducer sheath 24, radially retracts the prosthesis 46 to the surgical site spanning the aortic aneurysm. With reference to Figures 1-6, the introducer sheath 24 can then be at least partially retracted from the prosthesis 46, thereby at least partially releasing the prosthesis 46 from radial retraction within the introducer sheath 24. In one embodiment, the proximal handle 12 is rotated, thereby partially retracting the introducer sheath 24. Rotation of the proximal handle 12 to retract the introducer sheath 24 is enhanced by moving the edge 40 of the hub 38 along the helical track 42 defined by the inner surface 44 of the proximal handle 12, thereby providing control over the position of the introducer sheath 24 relative to the prosthesis 46. Such control is particularly important during orientation of the proximal end 50 of the prosthesis 46 to an optimal placement location. Once the position of the proximal end 50 of the prosthesis 46 has been optimized and the introducer sheath 24 has been sufficiently retracted to permit placement of the proximal end 50 of the prosthesis 46, retraction of the introducer sheath 24 may continue. Continued retraction of the introducer sheath 24 can be performed either by rotating the proximal handle 12, thereby continuing to move the hub 38 along the helical track 42 of the proximal handle 12, or alternatively by orienting the proximal handle 12 along a straight track 36 in the proximal direction 48, thereby allowing a direct relationship between the position of the proximal handle 12 and the degree of retraction of the introducer sheath 24 relative to the prosthesis 46.

[0021] In another embodiment of the method of use of the aortic vascular delivery system 10 of the present invention, the introducer sheath 24 may be partially retracted by rotation of the proximal handle 12 while adjacent the distal handle 18, followed by further retraction of the introducer sheath 24 by direct withdrawal of the proximal handle 12 in the proximal direction 48. Further retraction of the introducer sheath 24 may be completed, thereby fully or only partially exposing the prosthesis 46. When the further retraction by direct withdrawal along the straight track 36 of the proximal handle 12 and therefore hub 38 is partial, the proximal handle 12 may be rotated to return the proximal handle 12 to adjacent relationship with the distal handle 18, and then further rotated to continue retraction of the introducer sheath 24 while bringing it into adjacent relationship with the distal handle 18. In this manner, the leverage and control provided by the movement of the edge 40 of the hub 38 along the helical track 42 of the proximal handle 12 may be applied at intervals and interrupted by more rapid retraction permitted by direct withdrawal of the proximal handle 12 in the proximal direction 48 during the course of implantation of the prosthesis 46. The overall length of the portions of the aortic vascular delivery device 10 may thereby be minimized during implantation.

[0022] After complete release of the prosthesis at the surgical site, the aortic prosthesis delivery system 10 may be retracted from the patient. Orientation of the proximal end 50 of the prosthesis 46 relative to the surgical site is particularly important when, for example, the prosthesis 46 is fenestrated and must be rotationally oriented to align an arterial branch vessel with at least one fenestration defined by the prosthesis 46. The option for control over retraction of the introducer sheath 24 may also be advantageous when, for example, the prosthesis 46 being delivered is a bifurcated prosthesis that must be directed through the fenestrations of a previously implanted prosthesis and into the branch vessel.

[0023] The relevant teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety. ,408,734;No.9,408,735;No.8,500,792;No.9,220,617;No.9,364,314;No.9,101,506;No.8,998,970;No.9,554,929 ; No. 9,439,751; No. 9,592,112; No. 9,655,712; No. 9,827,123; No. 9,877,857; No. 9,907,686; No. 10,105,248; No. 10,307; 275;10,524,893;10,390,932;10,213,291;10,646,365;10,390,932;10,898,357;U.S. Patent Application Nos. 14 / 272,818;15 / 478,424;15 / 604,032;16 / 507,304;15 / 672,404;16 / 414,292;PCT / US2017 / 025849; The relevant teachings of Nos. 16 / 379,423; 16 / 379,490; 16 / 379,354; 16 / 391,843; 16 / 391,995; 16 / 392,443; 16 / 414,208; 16 / 414,132; 16 / 433,654; 16 / 433,823; 16 / 513,559 and 17 / 200,213 are also incorporated by reference in their entirety.

[0024] While exemplary embodiments have been particularly shown and described, it will be understood by those skilled in the art that various changes in form and detail can be made in the invention without departing from the scope of the embodiments encompassed by the appended claims.

Claims

1. a) a distal handle, wherein the distal handle has a proximal end and a distal end, the proximal end and the distal end defining a longitudinal axis; b) a straight track extending proximally from the distal handle along the longitudinal axis; c) a hub that is on a straight track and is slidable along the straight track; d) an introducer sheath secured to and extending distally from the hub, wherein the introducer sheath extends distally from the distal handle; e) a proximal handle proximal to the distal handle and longitudinally slidable along a straight track, wherein the proximal handle defines a helical track having a length of longitudinal travel along the longitudinal axis, the proximal handle is rotatable about the longitudinal axis, the hub and the proximal handle intermesh, and rotation of the proximal handle about the hub causes longitudinal movement of the hub along the length of the longitudinal axis and the straight track relative to the proximal handle, while the proximal handle remains fixed relative to the distal handle, and the length of hub travel is limited by the length of travel of the helical track of the hub, and the hub and introducer sheath are proximally movable along the straight track by at least one of rotation of a direct longitudinal force relative to the proximal handle and rotation of the proximal handle about the longitudinal axis; 1. An aortic prosthesis delivery system comprising:

2. 2. The aortic prosthesis delivery system of claim 1, wherein the hub includes a raised edge that follows a helical track of the proximal handle when the proximal handle is rotated about the longitudinal axis, thereby causing proximal movement of the hub and introducer sheath.

3. The aortic prosthesis delivery system of claim 2 , wherein the hub rim extends radially outward from the hub and from the longitudinal axis, and the helical track defines at least a portion of the interior space of the proximal handle.

4. The aortic prosthesis delivery system of claim 3 , wherein the hub is confined to an interior space of the proximal handle.

5. 5. The aortic prosthesis delivery system of claim 4, further comprising a guidewire catheter extending through the hub, the distal handle, the proximal handle and the introducer sheath.

6. An aortic prosthesis delivery system as defined in any one of claims 1 to 5 for use in a method for treating an aortic aneurysm, the system including an aortic prosthesis radially constrained within a distal end of an introducer sheath, the proximal handle being proximal to and adjacent the distal handle and engaging a hub in a helical track defined by an inner surface of the proximal handle, the hub being secured to the proximal end of the introducer sheath, the method comprising: a) delivering the aortic prosthesis through an artery to an aortic aneurysm of a patient, where a distal end of an introducer sheath is proximal to the aneurysm; b) rotating said proximal handle, thereby moving the hub proximally-most along a straight track extending into the proximal handle and distally from the distal handle adjacent the proximal handle, such that the introducer sheath is at least partially retracted from the aortic prosthesis at the aortic aneurysm and at least partially released from radial constraint by the introducer sheath; 1. An aortic prosthesis delivery system comprising:

7. 7. The system of claim 6, wherein the introducer sheath is partially retracted from the aortic prosthesis, the method further comprising the step of applying a proximal longitudinal force to the proximal handle, thereby sliding the hub proximally along the straight track and the introducer sheath, further withdrawing it from the stent graft.

8. 8. The system of claim 7, wherein the aortic prosthesis defines a fenestration and the aneurysm is in a portion of the artery that includes an arterial branch with which the fenestration must be aligned, the method further comprising the step of rotationally orienting the aortic prosthesis to align the fenestration with the arterial branch.

9. The system of claim 8 , wherein the step of applying a proximal longitudinal force to the proximal handle is performed after aligning the fenestration of the aortic prosthesis with the arterial branch.

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