Sutureless anastomosis connection device

Abstract

1. A prosthetic anastomosis fixation device comprising: an inner support structure; and an outer support structure positioned about the inner support structure and coupled to a prosthetic device, wherein the inner support structure comprises an expandable structure radially movable between an unexpanded configuration and an expanded configuration, wherein in the expanded configuration, the inner support structure provides a radially outward force toward an inner surface of the outer support structure, and the inner and outer support structures are sized and configured to receive a portion of a biological conduit between the inner support structure and the outer support structure such that in the expanded configuration, the portion of the biological conduit is fixedly secured between the inner surface of the outer support structure and the outer surface of the inner support structure.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 291,063, filed December 17, 2021, which is incorporated by reference in its entirety herein.

[0002] SUMMARY The present disclosure relates to anastomosis devices for connecting native blood vessels to vascular grafts and other prosthetic devices. [Background technology]

[0003] Resection and replacement of the aorta for aneurysmal disease and dissection is a common procedure in which the use of handsewn anastomoses to connect vascular grafts to the native vessels remains the standard of care. In ascending aortic dissection, replacement is necessary because the mortality rate with nonoperative treatment is very high (1% mortality / hour). The exact incidence of aortic replacement for dissection is not known, but population-based studies suggest an incidence of 30,000-80,000 cases per year in the United States. In dissection, the integrity of normal tissue is compromised, making the creation of a standard handsewn anastomosis one of the most challenging procedures in cardiac surgery. As a result, the time to create this anastomosis is often long, suture line bleeding is common, and can be very difficult to manage. Furthermore, these procedures require a period of hypothermic circulatory arrest to perform the distal aortic anastomosis. The time to create the anastomosis often significantly prolongs the period of circulatory arrest, and prolonged periods of circulatory arrest are associated with increased neurological events and end-organ dysfunction.

[0004] Elective resection of aortic aneurysms is also a common procedure in which handsewn anastomoses are typically used. The exact number of elective resections of aortic aneurysms is unknown, but estimates from the Society of Thoracic Surgeons suggest 15,000-20,000 cases per year in the United States. A similar number of procedures are performed in the EU. These patients often have thin-walled aortas and require periods of hypothermic circulatory arrest. Rapid creation of a hemostatic anastomosis with the devices described herein that eliminate the need for needles and sutures prevents problems associated with delicate native tissue and eliminates problems associated with long periods to create anastomoses. Furthermore, this approach can potentially improve patient outcomes by allowing the surgeon to safely extend the extent of the aortic resection. Up to 30% of patients who have their ascending aorta resected will require treatment for progressive aneurysmal disease of the aortic arch. The rapid and effective anastomosis device described herein allows the surgeon to extend the resection to include the aortic arch and then perform a rapid and safe anastomosis to the proximal descending thoracic aorta. Rapid anastomosis to the arch branch vessels can then be performed, eliminating concerns about progression of aortic arch disease.

[0005] Heart failure is another exemplary procedure in which hand-sewn anastomosis is used to connect the native atrium to an artificial heart. While prognosis remains poor, the incidence of heart failure continues to increase, with few options available for patients who fail medical therapy. Heart transplants are limited to fewer than 6,000 per year worldwide. The National Institutes of Health continues to identify the need for improved mechanical circulatory support (MCS) devices, estimating that up to 175,000 patients could benefit immediately from MCS. Current generation left ventricular assist devices (LVADs) have improved outcomes but are still associated with significant morbidity, including high stroke rates (8% at 1 year) and mortality (5-year survival rate 46%). Importantly, continuous-flow total artificial hearts (TAHs) have been developed, but a major problem associated with TAH implantation is the scope of surgical therapy. Creation of the anastomosis of the native atrium to the atrial cuff of the TAH is particularly challenging due to the thin atrial tissue with frequent lacerations to the tissue and / or pinhole bleeding. Time-consuming double sutures are often used to avoid both bleeding and air entrainment through the sutures with the potential for cerebral pneumoembolism. The development of a TAH atrial cuff described herein that can be rapidly anastomosed to native atrial tissue and provides improved hemostasis (1) reduces surgical complexity, (2) reduces intraoperative and perioperative bleeding, and (3) shortens cardiopulmonary bypass time. Prolonged cardiopulmonary bypass time increases both intraoperative morbidity and mortality.

[0006] In summary, there is a need in the art for a quickly and easily implanted sutureless anastomosis for connecting native blood vessels to vascular grafts, total artificial heart devices, or other biological conduits, such as the bile ducts, ureters, and / or fallopian tubes. Summary of the Invention

[0007] Certain examples of the present disclosure provide a sutureless anastomosis fixation device.

[0008] The prosthetic anastomosis fixation devices disclosed herein comprise an inner support structure and an outer support structure positioned around the inner support structure and coupled to the prosthetic device, the inner support structure comprising an expandable structure radially movable between an expanded configuration and an unexpanded configuration, wherein in the expanded configuration the inner support structure provides a radially outward force toward an inner surface of the outer support structure, the inner and outer support structures being sized and configured to receive a portion of a patient's blood vessel between the inner support structure and the outer support structure such that in the expanded configuration, the portion of the patient's blood vessel is fixedly secured (e.g., in a circumferential direction) between the inner surface of the outer support structure and the outer surface of the inner support structure.

[0009] A method of attaching a prosthetic anastomosis device to a patient's blood vessel using the fixation devices disclosed herein includes advancing a prosthetic fixation device to a treatment site at an opening of the patient's blood vessel, the prosthetic fixation device including an inner support structure with an expandable structure radially movable between an unexpanded configuration and an expanded configuration, and an outer support structure positioned about the inner support structure and coupled to a distal end of the prosthetic device. The method further includes advancing the inner support structure in the unexpanded configuration within the opening of the patient's blood vessel, positioning the outer support structure adjacent to an outer surface of the patient's blood vessel, and radially expanding the inner support structure toward the expanded configuration such that the inner support structure provides a radially outward force against an inner surface of the outer support structure, thereby fixing a portion of the patient's blood vessel between the inner surface of the outer support structure and the outer surface of the inner support structure.

[0010] Further implementations of the prosthetic anastomosis fixation devices disclosed herein include an inner support structure and an outer support structure positioned about the inner support structure and coupled to the prosthetic device, the inner support structure being sized and configured to receive a portion of the biological conduit between the inner support structure and the outer support structure such that, in the expanded configuration, the inner support structure provides a radially outward force toward an inner surface of the outer support structure, and the inner and outer support structures are sized and configured to receive a portion of the biological conduit between the inner support structure and the outer support structure such that, in the expanded configuration, the portion of the biological conduit is fixedly secured between the inner surface of the outer support structure and the outer surface of the inner support structure.

[0011] Another embodiment of the prosthetic anastomosis fixation device disclosed herein comprises an inner support structure coupled to the prosthetic device and an outer support structure positioned about the inner support structure, where the inner support structure comprises an expandable structure radially movable between an unexpanded configuration and an expanded configuration, where in the expanded configuration the inner support structure provides a radially outward force toward an inner surface of the outer support structure, and the inner and outer support structures are sized and configured to receive a portion of a patient's cardiac tissue (e.g., atrium, blood vessel) between the inner support structure and the outer support structure such that in the expanded configuration, the portion of the patient's cardiac tissue (e.g., atrium, blood vessel) is secured between the inner surface of the outer support structure and the outer surface of the inner support structure.

[0012] Another method of attaching a prosthetic anastomosis device to a patient's blood vessel using the fixation devices disclosed herein includes advancing the prosthetic fixation device to a treatment site at an opening of the patient's blood vessel, the prosthetic fixation device comprising an inner support structure coupled to the prosthetic device, the inner support structure comprising an expandable structure radially movable between an unexpanded configuration and an expanded configuration, and an outer support structure configured to be positioned about the inner support structure. The method further includes advancing the inner support structure in the unexpanded configuration within the opening of the patient's blood vessel, positioning the outer support structure adjacent an outer surface of the patient's blood vessel, and radially expanding the inner support structure toward the expanded configuration such that the inner support structure provides a radially outward force against an inner surface of the outer support structure, thereby fixing a portion of the patient's blood vessel between the inner surface of the outer support structure and the outer surface of the inner support structure.

[0013] A further method of attaching a prosthetic anastomosis device to a patient's blood vessel using the fixation devices disclosed herein includes advancing a prosthetic fixation device to a treatment site at an opening of the patient's blood vessel, the prosthetic fixation device including an inner support structure coupled to the prosthetic device, the inner support structure comprising an expandable structure radially movable between an unexpanded configuration and an expanded configuration, and an outer support structure configured to be positioned around the inner support structure. The method further includes attaching the outer support structure to the blood vessel, advancing the inner support structure in the unexpanded configuration within the opening of the patient's blood vessel, positioning the outer support structure adjacent to an outer surface of the patient's blood vessel, and radially expanding the inner support structure toward the expanded configuration such that the inner support structure provides a radially outward force against an inner surface of the outer support structure, thereby fixing a portion of the patient's blood vessel between the inner surface of the outer support structure and the outer surface of the inner support structure.

[0014] The details of one or more embodiments of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims. [Brief description of the drawings]

[0015] [Figure 1] 1 is a schematic diagram of a patient anatomy having a prosthetic fixation device, according to some examples. [Diagram 2] 2 is a perspective view of the exemplary prosthetic fixation device of FIG. 1. [Diagram 3] 2 is a partial perspective view of the exemplary prosthetic fixation device of FIG. 1 in a closed / expanded configuration and including adjacent patient anatomy. [Figure 4] 2 is a perspective view of the exemplary prosthetic fixation device of FIG. 1. [Diagram 5] 2 is a partial cross-sectional view of the distal end of the exemplary prosthetic fixation device of FIG. 1. [Figure 6] 2 is a partial cross-sectional view of the distal end of the exemplary prosthetic fixation device of FIG. 1, including adjacent patient anatomy in an open / unexpanded configuration. [Figure 7] 7 is a partial cross-sectional view of the distal end of the exemplary prosthetic fixation device of FIG. 6, including the adjacent patient anatomy in a closed / expanded configuration. [Figure 8] 1 is a schematic diagram of a patient anatomy with a prosthesis fixation device according to another example.

[0016] Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Disclosed herein is a rapid sutureless anastomosis that offers significant advantages over current hand-sewn techniques aimed at improving patient outcomes. The present disclosure provides devices and methods that allow rapid, hemostatic sutureless anastomosis in both cardiac and vascular surgery, as well as other procedures involving the attachment of grafts or other materials to hollow organs, such as urological or intestinal procedures. For example, the disclosed devices and methods can be used to anastomose a graft to a native heart, native blood vessel, or any hollow organ, and can also benefit patients requiring placement of a total artificial heart. As described herein, the anastomosis fixation device rapidly creates an anastomosis without any tissue penetrating the native tissue in a much faster manner compared to traditional hand-sewn techniques. Furthermore, the elimination of pinhole bleeding and reduced operative time leads to improved patient outcomes.

[0018] 1 shows a schematic diagram of a patient with an exemplary prosthetic anastomosis fixation device 10. The prosthetic fixation device 10 includes an inner support structure 20 and an outer support structure 30 circumferentially positioned about the inner support structure 20. A prosthetic device 50 is coupled to the inner support structure 20 and / or the outer support structure 30. The exemplary prosthetic device 50 includes a graft material and / or other biological conduit.

[0019] The inner and outer support structures 20, 30 are sized and configured to receive a portion of the patient's anatomy 40 (e.g., a blood vessel) between the inner support structure 20 and the outer support structure 30 such that the portion of the patient's anatomy (e.g., a blood vessel) is fixedly secured between the inner surface 32 of the outer support structure 30 and the outer surface 22 of the inner support structure 20. For example, the patient's blood vessel is secured circumferentially between the inner support structure 20 and the outer support structure 30.

[0020] The inner support structure 20 defines an annular, generally ring-shaped structure having a central lumen 24 extending therethrough. As shown in Figures 1-7, the inner support structure 20 and the outer support structure 30 are coupled at their proximal ends 26, 36 to a prosthetic device 50. The inner support structure 20 comprises an expandable structure that is radially movable between an unexpanded configuration (Figures 5, 6) and an expanded configuration (Figures 1, 3, 7).

[0021] 5 and 6, in the unexpanded configuration, the diameter of the inner support structure 20 at the proximal end 26 is larger than the diameter of the inner support structure 20 at the distal end 28. In the expanded configuration, the diameter of the inner support structure 20 at the distal end 28 corresponds to the diameter at the proximal end 26. In the expanded configuration, the inner support structure 20 provides a radially outward force toward the inner surface 32 of the outer support structure 30, thereby securing the patient's anatomy between the inner surface 32 of the outer support structure 30 and the outer surface 22 of the inner support structure 20. For example, in the expanded configuration, the inner support structure 20 is sized and configured to fit snugly inside the patient's anatomy 40 (e.g., the inner surface of a blood vessel). In some examples, the inner support structure 20 has an expanded diameter in the range of 1 mm to 100 mm, including exemplary values ​​of 1 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, and 100 mm. In still further embodiments, the diameter can have any value between any of the aforementioned values. For example, the diameter can be between 15 mm to 50 mm, 18 mm to 36 mm, 50 mm to 55 mm, 50 mm to 100 mm (and inclusive).

[0022] As shown in Figures 1, 4 and 7, the axial length of the inner support structure 20 in the expanded configuration corresponds to the length of the outer support structure 30. Alternatively, in the expanded configuration, the inner support structure 20 can have a length that is greater or less than the length of the outer support structure 30. In some examples, the inner and outer support structures 20, 30 have a length in the range of 0.5 cm to 6.5 cm, including exemplary values ​​of 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, 4.5 cm, 5.0 cm, 5.5 cm, 6.0 cm, 6.5 cm. In still further embodiments, the length of the inner and outer support structures 20, 30 has any value between any of the aforementioned values. For example, the length can be between 2.0 cm and 6.0 cm (and inclusive).

[0023] The inner and outer support structures 20, 30 can have the same or varying thickness (measured radially between the inner and outer surfaces of the corresponding inner and outer support structures 20, 30). In some examples, the thickness of each of the inner and outer support structures 20, 30 ranges from 0.5 mm to 3 mm, with exemplary values ​​of 0.5 mm, 1 mm, 1.5 mm, 2.0 mm, 2.5 mm, and 3.0 mm. In still further embodiments, the thickness of the inner and outer support structures 20, 30 has any value between any of the aforementioned values. For example, the thickness can be between 1.0 mm and 2.5 mm (and inclusive). In some examples, the inner support structure 20 comprises an expandable stent coupled at a proximal end to the prosthetic device 50. Generally, as the stent-like proximal end 26 of the inner support structure 20 is coupled to the prosthetic device 50, when the inner support structure 20 expands the diameter of the distal end 28 of the stent-like inner member, the diameter of the proximal end of the stent line inner member remains constant, but the diameter of the distal end of the stent-like inner member expands. In some instances, in the unexpanded configuration, the distal end portion of the stent-like inner member is more crimped and has a smaller diameter than the proximal end portion of the stent-like inner member so that the patient's anatomy 40 can be advanced between the inner support structures 20, 30 and the outer support structure 30. The distal end portion of the stent-like inner member is then expanded from the unexpanded configuration to the expanded configuration. As a result, the patient's anatomy 40 is secured between the stent-like inner member (the inner support structure 20) and the outer support structure 30.

[0024] The inner support structure 20 can include an exposed / uncovered expandable stent such that the inner support structure 20 does not include a covering and / or coating on all or a portion of its interior or exterior surfaces. For example, the inner support structure 20 can include a bare metal expandable stent. In further embodiments, the inner support structure 20 includes a covering material (e.g., fabric), for example, the inner support structure 20 comprises a fabric covered expandable stent. The covering material prevents damage to the patient's anatomy 40 and also enhances grip / resistance between the inner support structure 20 and the patient's anatomy 40 when securing the fixation device 10.

[0025] As discussed above, the prosthetic fixation device 10 includes an outer support structure 30 circumferentially disposed about the inner support structure 20. As shown in Figures 1-7, the outer support structure 30 defines a generally annular, ring-shaped structure having a central lumen 34 extending therethrough.

[0026] As described above, the prosthetic device 50 is coupled to the inner support structure 20 and / or the outer support structure 30. In some examples, the prosthetic device 50 is coupled to both the inner support structure 20 and the outer support structure 30. In other examples, the prosthetic device 50 is coupled to the outer support structure 30 and is separate from the inner support structure 20. In this example, the outer support structure 30 (and the prosthetic device 50) is positioned adjacent to a corresponding portion of the patient's anatomy 40. Once positioned, the inner support structure 20 is advanced within the central lumen of the patient's anatomy / vessel and expanded to secure the anatomy between the inner support structure 20 and the outer support structure 30.

[0027] In a further example, the prosthetic device 50 is coupled to the inner support structure 20 and separate from the outer support structure 30. In this example, the inner support structure 20 (and the prosthetic device) is positioned adjacent to a corresponding portion of the patient's anatomy 40. Once the inner support structure 20 is positioned, the outer support structure 20 is separately advanced and positioned over the patient's anatomy / vessel, and the inner support structure is expanded to secure the anatomy 40 between the inner support structure 20 and the outer support structure 30. The outer support structure 30 may be separately coupled to the outer surface of the patient's anatomy 40. For example, the outer support structure 30 is coupled to the outer surface of the vessel, e.g., the atrial tissue. In some examples, the outer support structure 30 is coupled to the vessel using mechanical and / or chemical fasteners (e.g., an adhesive such as BioGlue™ by CryoLife). In some embodiments, the outer support structure 30 includes a material (e.g., a felt material) that is coupled to the vessel atrial tissue using an adhesive. In the exemplary fixation device 10, the inner surface 32 of the outer support structure 30 includes a textured surface and / or coating to improve grip between the fixation device 10 and the patient's anatomy 40. The textured surface and / or coating may also allow for tissue ingrowth between the outer support structure 30 and the patient's anatomy 40. It is contemplated that the outer surface 22 of the inner support structure 20 may also include a textured surface and / or coating to improve grip with and / or allow for tissue ingrowth between the inner support structure 20 and the patient's anatomy 40. Exemplary textured surfaces include flocked surfaces, laser etched surfaces, deposited texture materials, adhesives deposited on the surfaces of the inner and / or outer support structures 20, 30, and combinations thereof.

[0028] The outer support structure 30 is sized and configured to fit snugly around the outside of the patient's anatomy, for example, in a circumferential direction, around the outer surface of the patient's blood vessel. In some examples, the outer support structure 30 does not provide a radially inward force, and the patient's anatomy 40 is secured to the outer support structure 30 by the radially outward force of the inner support structure 20. In other examples, the outer support structure 30 provides a radially inward force to compress the patient's anatomy 40 between the inner support structure 20 and the outer support structure 30. In further examples, the inner support structure 20 provides an outward force, and the outer support structure 30 provides an inward force to secure the patient's anatomy 40 between adjacent layers of the fixation device 10.

[0029] The outer support structure 30 is sized and configured to conform to the outer surface of the patient's anatomy 40 (e.g., the outer surface of a blood vessel). In some examples, the outer support structure 30 has a diameter ranging from 1 mm to 100 mm, including exemplary values ​​of 1 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, 100 mm. In still further embodiments, the diameter can have any value between any of the aforementioned values. For example, the diameter can be between 15 mm and 50 mm, 50 mm and 100 mm (and inclusive).

[0030] The outer support structure 30 is configured to fit snugly around a patient's anatomy (e.g., a blood vessel), but may be constructed from a material that allows the outer support structure 30 to be removed from and / or repositioned on the inner support structure 20. For example, as described below, the outer support structure 30 may be constructed from a polymeric material, including an elastomeric polymeric material, configured to expand to a larger diameter and contract toward an initial unexpanded diameter. The outer support structure 30 may further include weakened structures, such as scorelines and / or etchings, that allow the outer support structure 30 to tear or stretch along the weakened structures. The outer support structure 30 may include multiple weakened structures spaced around the circumference of the outer support structure 30. During use, the outer support structure 30 is positioned over the patient's anatomy 40 in a position corresponding to the inner support structure 20. If it becomes necessary to reposition or remove the medial and / or lateral support structures 20, 30, the physician can tear or stretch the outer support structure 30 along the weakened structures / score lines and remove the outer support structure 30 from the patient's anatomy 40.

[0031] It is contemplated that the fixation device 10 will include fixation structures (i.e., inner and outer support structures 20, 30) coupled to both ends of the prosthetic device 50 such that the fixation device 10 may be used to join adjacent portions of a patient's anatomy, for example, linking the prosthetic device 50 between adjacent segments of a patient's blood vessel.

[0032] For example, the fixation device 10 includes a first inner support structure 20a and an outer support structure 30a coupled to a proximal end 52 of the prosthetic device 50, and a second inner support structure 20b and an outer support structure 30b at a distal end 53 of the prosthetic device 50. The second inner support structure 20b and the outer support structure 30b can include similar designs and functions as the first inner support structure 20a and the outer support structure 30a. For example, the second inner support structure 20b can include an expandable structure (e.g., a radially expanding stent) that is radially movable between an unexpanded configuration and an expanded configuration. The second outer support structure 30b is positioned circumferentially around the second inner support structure 20b. The distal end 54 of the prosthetic device 50 can be coupled to either the second inner support structure 20b and / or the second outer support structure 30b. Similar to the fixation structure at the proximal end 52 of the prosthetic device 50, the second inner and outer support structures 20b, 30b are sized and configured to receive a second portion of the patient's anatomy 40 (e.g., a second opening of the patient's blood vessel) between the second inner support structure 20b and the second outer support structure 30b, whereby the portion of the patient's anatomy 40 (e.g., the blood vessel) is fixedly secured between the inner support structure 20b and the outer support structure 30b. For example, in the expanded configuration, the second inner support structure 20b provides a radially outward force toward the inner surface of the second outer support structure 30b that fixes the second opening of the patent's anatomy 40 between the second inner support structure 20b and the second outer support structure 30b.

[0033] Generally, the inner support structure 20 and the outer support structure 30 are constructed from biologically inert materials. For example, the inner support structure 20 and / or the outer support structure 30 are constructed from at least one of a metal (e.g., stainless steel, nitinol) and a polymer (e.g., polyethylene, Teflon®). In some examples, the outer support structure 30 is constructed from a felt material reinforced with an adhesive.

[0034] In some examples, the inner support structure 20 is constructed from a magnetic material and / or includes magnetic elements that are magnetically attracted to the outer support structure 30. Alternatively, the outer support structure 30 can be constructed from a magnetic material and / or includes magnetic elements that are magnetically attracted to the inner support structure 20.

[0035] As discussed above, the exemplary prosthetic device 50 includes graft materials and / or other prosthetic biological conduits. In one particular example, the prosthetic device 50 includes a vascular graft. The prosthetic device 50 is constructed from a biocompatible synthetic material. Examples of biocompatible synthetic materials include polytetrafluoroethylene (PTFE), polyester (e.g., Dacron®, Gortex®), silk fibroin, polyurethane, and / or any other material known in the art that is suitable as a replacement for a biological conduit.

[0036] In some examples, in the anastomosis fixation device 10, the prosthetic device 50 is impregnated with a material to promote sealing and / or prevent infection. For example, the impregnating material can include a sealant (e.g., gelatin, collagen) to promote sealing between the patient's vasculature and the prosthetic device 50. Additionally / alternatively, the impregnating material can include additives (e.g., antibiotics, disinfectants) that inhibit bacterial infection. In one particular example, the prosthetic device 50 is a gelatin-impregnated woven polyester vascular graft.

[0037] The use of an exemplary sutureless anastomosis fixation device 10 for aortic and other vascular surgery is described below. As explained above, the use of the anastomosis fixation device described herein allows for rapid hemostatic anastomosis techniques that improve the outcome of complex surgeries such as dissection of the ascending aorta and resection of aortic aneurysms. The target patient anatomy includes the patient's blood vessels, including, for example, arterial segments, venous segments, and / or atrial structures. It is further contemplated that the target patient anatomy may include any other biological conduit, such as the bile duct, ureter, or fallopian tube. Although the method for positioning the fixation device 10 within the patient anatomy is described with reference to the patient's blood vessels, a similar method may be used to connect the prosthetic device 50 to any other biological conduit.

[0038] First, an opening is made in the patient's blood vessel, for example, by cutting a patent blood vessel. The diameter of the blood vessel may be measured to identify inner and outer support structures 20, 30 having a diameter corresponding to the measured diameter of the patient's blood vessel.

[0039] The fixation device 10 and corresponding prosthetic device 50 are coupled to the patient's anatomy by advancing the fixation device 10 to a treatment site at an opening in the patient's blood vessel. The inner support structure 20 is advanced in an unexpanded configuration within the opening in the patient's blood vessel. The outer support structure 30 is positioned adjacent the outer surface of the patient's blood vessel (adjacent the opening) in a position corresponding to the inner support structure 20.

[0040] In some examples, traction stitches are used to position the fixation device 10. For example, traction stitches are placed in the patient's blood vessel, e.g., single or multiple stitches are placed at various circumferential locations around the blood vessel. As shown in Figs. 2 and 4, the outer support structure 30 includes a window 38 extending from an outer surface to an inner surface of the outer support structure 30. The outer support structure 30 can include a single window 38 or multiple windows 38 spaced around the outer support structure 30 in a circumferential direction. In some examples, the window 38 includes a circular or linear shaped opening. In further examples, the window 38 includes a longitudinally extending opening slot extending from an end of the outer support structure 30 toward the prosthetic device 50. Positioning the inner support structure 20 and / or the outer support structure 30 in the opening of the patient's blood vessel includes positioning or otherwise seating the traction stitch in the window 38. For example, when the blood vessel includes the aorta, a traction stitch is placed on the aorta to ensure that the aorta is well seated within the inner and outer support structures 20, 30. The traction stitch may be removed after the fixation device 10 is secured to the patient's blood vessel.

[0041] Once the inner support structure 20 and the outer support structure 30 are positioned, the inner support structure 20 is radially expanded toward the expanded configuration such that the inner support structure 20 provides a radially outward force against the inner surface 32 of the outer support structure 30. As a result, a portion of the patient's blood vessel is secured between the inner surface 32 of the outer support structure 30 and the outer surface 22 of the inner support structure 20. In some embodiments, the outer support structure 30 includes a textured inner surface that grips the outer surface of the patient's blood vessel.

[0042] In embodiments where the blood vessel includes the aorta, positioning the outer support structure 30 adjacent to an exterior surface of the patient's blood vessel includes positioning the inner surface 32 of the outer support structure 30 adjacent to the adventitia of the aorta. Radial expansion of the inner support structure 20 secures aortic tissue between the inner support structure 20 and the outer support structure 30.

[0043] As explained above, the fixation device 10 includes fixation structures (inner and outer support structures 20, 30) at both ends of the prosthetic device 50 so that the fixation device 10 can be used to join adjacent portions of the patient's anatomical structure, i.e. link the prosthetic device 50 between adjacent segments of the patient's blood vessel. Thus, the fixation device 10 includes a first inner and outer support structure 20a, 30a provided at the proximal end 52 of the prosthetic device 50 and a second inner and outer ring 20b, 30b provided at the distal end 54 of the prosthetic device 50. As explained above, the fixation structure at the proximal end 52 is first coupled to the patient's anatomical structure. Then, the fixation structure at the distal end 54 of the prosthetic device 50 is coupled to the patient's blood vessel by advancing the second inner support structure 20b in an unexpanded configuration within a second opening in the patient's blood vessel 40. The second outer support structure 30b is positioned adjacent to the outer surface of the patient's blood vessel. The second inner support structure 20b is then radially expanded toward the expanded configuration such that the second inner support structure 20b provides a radially outward force against the inner surface 32 of the second outer support structure 30b. As a result, a second portion of the patient's blood vessel is secured between the inner surface 32 of the second outer support structure 30b and the outer surface 22 of the second inner support structure 20b.

[0044] The inner support structure 20a, 20b is manually radially expanded against the inner surface of the patient's blood vessel. In some embodiments, radially expanding the inner support structure 20a, 20b includes positioning a balloon expansion device within the central lumen of the inner support structure 20a, 20b and inflating the balloon to expand the inner support structure 20a, 20b. After the inner support structure 20a, 20b is secured against the blood vessel and the blood vessel is secured against the outer support structure 30a, 30b, the balloon expansion device is deflated and moved away from the inner support structure 20a, 20b and the patient's blood vessel. In some embodiments, the balloon expansion device is coupled to the inner support structure 20a, 20b and / or the outer support structure 30a, 30b. For example, the balloon expansion device is coupled to the inner and / or outer support structures 20, 30, and the support structures are positioned within the patient's anatomy at the treatment site, and accordingly the balloon expansion device is positioned to expand the inner support structure 20a, 20b. In a further embodiment, the balloon expansion device is separate from the inner and / or outer support structures 20,30.

[0045] In an exemplary process, when a portion of a patient's blood vessel is secured between the outer support structure 30a, 30b and the inner support structure 20a, 20b, a liquid-tight seal is formed between the inner support structure 20a, 20b, the blood vessel, and the outer support structure 30a, 30b. The seal between the inner support structure 20a, 20b, the blood vessel, and the outer support structure 30a, 30b is tested by flowing a fluid (e.g., saline, blood) through the prosthetic device 50. For example, the clamp upstream of the prosthetic device 50 is released and blood is flowed through the fixation device 10 / prosthetic device 50. If a leak at the fixation device is determined, i.e., there is no liquid-tight seal between the inner support structure 20a, 20b, the blood vessel, and the outer support structure 30a, 30b, the clamp is reapplied and the inner support structure 20a, 20b is additionally expanded to increase the radially outward pressure exerted by the inner support structure 20a, 20b toward the outer support structure 30a, 30b. For example, additional inflation of the balloon may be used to further expand the inner support structures 20a, 20b to achieve complete hemostasis.

[0046] 8 shows a schematic diagram of a patient having a prosthesis fixation device 10 according to another example. In this example, the artificial heart device 50 includes at least one of an artificial heart valve, a cardiac assist pump, and an artificial heart. For example, as presented in FIG. 8, the prosthetic device 50 is an atrial cuff of a total artificial heart.

[0047] The fixation device of Figure 8 includes similar structures and materials as the fixation devices of Figures 1-7. Like element numbers are used to identify like structures. Differences between the fixation devices of Figures 1-7 and the device of Figure 8 are presented in more detail below.

[0048] The fixation device 10 of FIG. 8 includes an inner support structure 20 coupled to a prosthetic device 50 (i.e., an atrial cuff) and an outer support structure 30 positioned around the inner support structure 20. Similar to the devices described above, the inner support structure 20 comprises an expandable structure that is radially movable between an unexpanded configuration and an expanded configuration. In the expanded configuration, the inner support structure 20 provides a radially outward force against the patient's anatomy and toward the inner surface 32 of the outer support structure 30. The inner and outer support structures 20, 30 are sized and configured to receive a portion of the patient's heart tissue (e.g., atrium). Thus, in the expanded configuration, this portion of the patient's atrium is secured between the inner surface 32 of the outer support structure 30 and the outer surface 22 of the inner support structure 22.

[0049] The inner support structure 20 and the outer support structure 30 each have an annular shape with a corresponding central lumen extending therethrough. In some examples, the cross-sectional shape of the central lumen of each of the inner and outer support structures 20, 30 corresponds to the cross-sectional shape (e.g., the cross-sectional shape of a transverse cross section) of the atrium.

[0050] In the expanded configuration, the inner support structure 20 is sized and configured to fit snugly within the atrium of the patient. The diameter / width of the inner support structure 20 ranges from 20 mm to 100 mm, including exemplary values ​​of 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, 100 mm. In still further embodiments, the diameter / width may have any value between any of the aforementioned values. For example, the diameter may be between 20 mm to 70 mm, 30 mm to 70 mm (and inclusive). As shown in FIG. 8, the length of the inner support structure 20 in the expanded configuration is greater than the length of the outer support structure 30. In other examples, the length of the inner support structure 20 in the expanded configuration corresponds to the length of the outer support structure 30.

[0051] The use of an exemplary sutureless anastomosis fixation device 10 for aortic surgery and implantation of a total artificial heart is described below. As mentioned above, the anastomosis fixation device described herein allows for a rapid hemostatic technique for creating an anastomosis of the native atrium to the atrial cuff of a total artificial heart.

[0052] First, an opening is made in the patient's atrium, e.g., the heart is removed to expose the open atrium, and the diameter and / or width of the opening is measured to identify inner and outer support structures 20, 30 having corresponding diameters and / or widths.

[0053] The fixation device 10 and corresponding prosthetic device 50 are coupled to the patient's atrium by advancing the fixation device 10 to the treatment site of the opening in the patient's atrium. The inner support structure 20 is advanced in an unexpanded configuration within the opening such that the outer surface 22 of the inner support structure 20 is adjacent the inner surface of the atrium. The outer support structure 30 is positioned adjacent the outer surface 32 of the atrium at a location corresponding to the inner support structure 20 such that atrial tissue is positioned between the inner support structure 20 and the outer support structure 30.

[0054] In some instances, traction stitches are used to position the fixation device 10. For example, the traction stitches are placed in the atrium, e.g., single or multiple stitches may be placed at various circumferential locations around the atrium. The outer support structure 30 includes a window 38 extending through the outer support structure 30. As explained above, the outer support structure 30 may include a single window 38 or multiple windows 38 spaced circumferentially around the outer support structure 30. Positioning the inner support structure 20 and / or the outer support structure 30 within the opening of the patient's atrium includes positioning or otherwise seating a traction stitch within the window 38.

[0055] Once the inner support structure 20 and the outer support structure 30 are positioned, the inner support structure 20 is then radially expanded toward the expanded configuration such that the inner support structure 20 provides a radially outward force against the atrium and the inner surface 32 of the outer support structure 30. As a result, a portion of the patient's atrium is secured between the inner surface 32 of the outer support structure 30 and the outer surface 22 of the inner support structure 20. In some examples, the inner and / or outer support structures 20, 30 include textured surfaces to improve grip with atrial tissue.

[0056] In some embodiments, radially expanding the inner support structure 20 includes manually expanding the inner support structure 20 against the inner surface of the patient's atrium.

[0057] In some embodiments, radially expanding the inner support structure 20 includes positioning a balloon expansion device within a central lumen of the inner support structure 20 and inflating the balloon to expand the inner support structure 20. After the inner support structure 20 is anchored to the atrium and the atrium is anchored to the outer support structure 30, the balloon expansion device is deflated and removed from the inner support structure 20 and the patient's atrium.

[0058] In an exemplary process, a portion of the patient's atrium is secured between the outer support structure 30 and the inner support structure 20, forming a fluid-tight seal between the inner support structure 20 and the atrium and between the inner support structure 20 and the outer support structure 30. The seal between the inner support structure 20 and the atrium and the outer support structure 30 is tested by flowing fluid through the prosthetic device 50. For example, an occluder is introduced into the central lumen of the atrial cuff. A Foley catheter is advanced upstream of the prosthetic device and inflated to occlude blood flow through / from the pulmonary veins. Fluid (e.g., blood, saline) is provided into the central lumen of the atrial cuff and leakage around the inner and outer support structures 20, 30 is determined.

[0059] If a leak in the fixation device is determined, i.e., there is no fluid-tight seal between the inner support structure 20 and the atrium and the outer support structure 30, the inner support structure 20 is expanded additionally to increase the radially outward pressure exerted by the inner support structure 20 towards the outer support structure 30. For example, additional inflation of a balloon may be used to further expand the inner support structure 20 to achieve complete hemostasis.

[0060] While several embodiments of the invention have been disclosed in the foregoing specification, it will be understood by one skilled in the art that many modifications and other embodiments of the invention to which this invention pertains will come to mind having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. It is understood, therefore, that the invention is not limited to the specific embodiments disclosed above, and that many modifications and other embodiments are intended to be included within the scope of the appended claims. Moreover, although specific terms have been employed in the specification, as well as in the claims that follow, they are used in a generic and descriptive sense only and not for the purpose of limiting the invention described or the claims that follow. We therefore claim as our invention all that comes within the scope and spirit of these claims.

Claims

1. 1. A prosthesis fixation device comprising: an inner support structure; an outer support structure positioned around the inner support structure and coupled to the prosthetic device; the inner support structure comprises an expandable structure radially movable between an unexpanded configuration and an expanded configuration; the inner support structure provides a radially outward force toward an inner surface of the outer support structure in the expanded configuration; A device, wherein the inner support structure and the outer support structure are sized and configured to receive a portion of the biological conduit between the inner support structure and the outer support structure such that in the expanded configuration, the portion of the biological conduit is fixedly secured between the inner surface of the outer support structure and the outer surface of the inner support structure.

2. a second inner support structure comprising an expandable structure radially movable between the unexpanded configuration and the expanded configuration; and a second outer support structure positioned around the second inner support structure and coupled to a distal end of the prosthetic device; the second inner support structure provides a radially outward force toward an inner surface of the second outer support structure in the expanded configuration; 2. The device of claim 1, wherein the second inner support structure and the second outer support structure are sized and configured to receive the second portion of the biological conduit between the second inner support structure and the second outer support structure such that in the expanded configuration, the second portion of the biological conduit is fixedly secured between the inner surface of the second outer support structure and the outer surface of the second inner support structure.

3. the outer support structure is coupled to the prosthetic device at a proximal end of the outer support structure; The device of claim 1 , wherein the inner support structure is coupled to the prosthetic device at a proximal end of the inner support structure.

4. The device of claim 3 , wherein a proximal end diameter of the inner support structure is greater than a distal end diameter of the inner support structure in the unexpanded configuration.

5. The device of claim 1 , wherein the inner support structure and the outer support structure each define an annular ring shape.

6. The device of claim 1 , wherein the inner support structure is an expandable stent.

7. 7. The device of claim 6, wherein a distal end portion of the expandable stent expands from an unexpanded configuration to an expanded configuration, and in the unexpanded configuration, the distal end portion is more crimped than a proximal end portion of the expandable stent.

8. The device of claim 1 , wherein the inner support structure comprises a fabric-covered expandable stent.

9. The device of claim 1 , wherein the inner support structure is magnetically attracted to the outer support structure.

10. the inner support structure is sized and configured to fit snugly inside the biological conduit in the expanded configuration; The device of claim 1 , wherein the outer support structure is sized and configured to fit snugly against the outside of the biological conduit.

11. The device of claim 1 , wherein the length of the inner support structure in the expanded configuration corresponds to the length of the outer support structure.

12. The device of claim 1 , wherein the length of the inner support structure is greater than or less than the length of the outer support structure.

13. The device of claim 1 , wherein the inner surface of the outer support structure includes a textured surface for gripping the biological conduit.

14. 14. The device of claim 13, wherein the textured surface comprises at least one of a flocked surface, a laser-etched surface, a textured material deposited on the inner surface of the outer support structure, or an adhesive deposited on the inner surface of the outer support structure.

15. The device of claim 1 , wherein the prosthetic device comprises at least one of a graft material, a biological conduit, a vascular graft, a prosthetic heart valve, a cardiac assist pump, or an artificial heart.

16. 10. The device of claim 1, wherein the prosthetic device is impregnated with an impregnation material comprising at least one of a sealant to promote a seal between the patient's vasculature and the prosthetic device, including gelatin, collagen, or an additive to inhibit bacterial infection.

17. 1. A method of attaching a prosthetic device to a biological conduit, comprising: a prosthesis fixation device advanced to the opening of the biological conduit, an inner support structure comprising an expandable structure radially movable between an unexpanded configuration and an expanded configuration; an outer support structure disposed about the inner support structure and coupled to a distal end of the prosthetic device; advancing the inner support structure in the unexpanded configuration within the opening of the biological conduit; positioning the outer support structure adjacent an exterior surface of the biological conduit; and radially expanding the inner support structure toward the expanded configuration such that the inner support structure provides a radially outward force against an inner surface of the outer support structure to secure a portion of the biological conduit between the inner surface of the outer support structure and the outer surface of the inner support structure.

18. the prosthetic fixation device further includes a second inner support structure comprising an expandable structure radially movable between the unexpanded configuration and the expanded configuration, and a second outer support structure positioned around the second inner support structure and coupled to a distal end of the prosthetic device; 18. The method of claim 17, further comprising: advancing the second inner support structure in the unexpanded configuration within a second opening of the biological conduit; positioning the second outer support structure adjacent to an outer surface of the biological conduit; and radially expanding the second inner support structure toward the expanded configuration such that the second inner support structure provides a radially outward force against an inner surface of the second outer support structure to secure a second portion of the biological conduit between the inner surface of the second outer support structure and the outer surface of the second inner support structure.

19. radially expanding the inner support structure includes positioning a balloon expansion device within a central lumen of the inner support structure and inflating the balloon to expand the inner support structure; 20. The method of claim 18, wherein after the inner support structure is secured to the biological conduit and the biological conduit is secured to the outer support structure, the balloon expansion device is deflated and moved away from the inner support structure and the biological conduit.

20. securing the portion of the biological conduit between the outer support structure and the inner support structure forms a fluid-tight seal between the inner support structure, the biological conduit, and the outer support structure; a seal between the inner support structure, the biological conduit, and the outer support structure is tested by flowing a fluid through the prosthetic device; 18. The method of claim 17, wherein if the fluid-tight seal between the inner support structure, the biological conduit, and the outer support structure is not determined, the inner support structure is additionally expanded.

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