Source: https://patents.google.com/patent/US8858489
Timestamp: 2018-02-22 05:40:08
Document Index: 291599929

Matched Legal Cases: ['Application No. 13186508', 'Application No. 08', 'Application No. 08', 'Application No. 08', 'Application No. 13186508', 'Application No. 2013', 'Application No. 2010', 'Application No. 2010']

US8858489B2 - Conduit device and system for implanting a conduit device in a tissue wall - Google Patents
Conduit device and system for implanting a conduit device in a tissue wall
US8858489B2
US8858489B2 US13845960 US201313845960A US8858489B2 US 8858489 B2 US8858489 B2 US 8858489B2 US 13845960 US13845960 US 13845960 US 201313845960 A US201313845960 A US 201313845960A US 8858489 B2 US8858489 B2 US 8858489B2
US13845960
US20130218169A1 (en )
The present application is a continuation of copending U.S. patent application Ser. No. 12/901,810 filed Oct. 11, 2010, which is a continuation of U.S. patent application Ser. No. 11/739,151, filed on Apr. 24, 2007, now U.S. Pat. No. 7,846,123 issued on Dec. 7, 2010, which are hereby incorporated by reference in their entirety herein.
This invention relates to devices and methods for creating and maintaining a fluid conduit to establish fluid communication between opposing surfaces of a tissue wall.
Construction of an alternative conduit between the left ventricle and the aorta (an apicoaortic conduit, or AAC) to create a double-outlet left ventricle (LV) has been successfully employed to treat a variety of complex congenital LV outflow obstruction (fibrous tunnel obstruction, aortic annular hypoplasia, tubular hypoplasia of the ascending aorta, and patients with diffuse septal thickening, severe LV hypertrophy and a small LV cavity) as well as adult-onset aortic stenosis in patients with complicating preoperative conditions (previous failed annular augmentation procedures, previous infection, previous coronary artery bypass graft (CABG) with patent anterior internal mammary artery grafts, and a porcelain ascending aorta).
However, the AAC insertion procedure has been poorly accepted, primarily because of early valve failures using first-generation bioprostheses as well as the success of direct left ventricle outflow tract obstruction (LVOTO) repair and aortic valve replacement. In the United States, despite an aging population, the unadjusted mortality for isolated aortic valve operations in 2001 remained under 4%. Further, the AAC insertion operation, with or without cardiopulmonary bypass, has not been as technically straightforward as direct aortic valve replacement. For most surgeons, AAC insertion is not a familiar operation and is of historical interest only.
The current techniques and technology available to perform AAC insertion were originally designed to be performed on-pump; either with an arrested or fibrillating heart. While off-pump cases have been described, they can be technically difficult due to the shortcomings of presently available conduits and systems for installing such conduits. For example, because existing conduits require the use of sutures to reliably secure the connector in place, it is often difficult for surgeons or other clinicians to insert such sutures reliably in active cardiac and/or vascular tissue.
Some devices and methods have been devised to install an AAC conduit, such as those described generally in U.S. patent application Ser. No. 11/251,100, filed on Oct. 14, 2005, and U.S. patent application Ser. No. 10/915,691, filed on Aug. 11, 2004, both of which are hereby incorporated herein in their entirety by reference. However, these AAC conduit devices and installation systems rely on the use of a flexible flange that is inserted through a pre-defined aperture in the ventricular apex. Thus, such methods require the use of a hemostatic device (such as an occlusion balloon and/or “umbrella” device) to prevent blood loss from the aperture during installation of the AAC conduit.
Various embodiments of the present invention provide an improved system and method for the insertion of a conduit (such as an AAC conduit) that will significantly simplify the in vivo insertion of a graft into the beating cardiac apex or other tissue walls (such as other areas of the heart including the anterior, lateral, posterior walls of the left or right ventricle, the left or right atrium, the aortic wall, ascending, transverse, or descending, or other blood vessel walls), such that vascular conduit insertions (including AAC procedures) may be rendered far more attractive to clinicians. Because vascular conduits and systems of the present invention may be used to create alternate outflow tracts in “off-pump” procedures, the embodiments of the present invention may effectively reduce and/or negate the detrimental effects of both cardio-pulmonary by-pass (CPB) and global cardiac ischemia. Additionally, because some conduit embodiments of the present invention (for AAC procedures, for example) may be inserted into a ventricular or atrial free wall or cardiac apex, the conduction system of the heart may be avoided, along with the native coronary arteries and grafts from previous surgical revascularization. In some embodiments of the present invention, wherein the system is used to implant an AAC, a small size valve (19 to 21 mm for typical adult body surface areas) is usually adequate; as the effective postoperative orifice is the sum of the native and prosthetic aortic valves. Further, the present invention provides vascular conduits that may be compatible with newer generation biologic valves, such that valved conduit failure is far less likely. Various embodiments of the present invention may also provide general conduit devices (and systems for implanting) suitable for establishing fluid communication between opposing surfaces of tissue walls in a variety of applications, including the establishment of a fluid conduit through the tissue wall of a mammalian urinary bladder.
Although some embodiments of the invention described herein are directed to a conduit device 1 (see FIGS. 1 and 7, for example) and a system for implanting such a device to form an apicoaortic connector (AAC) between the cardiac apex and the aorta, it will be appreciated by one skilled in the art that the invention is not so limited. For example, aspects of the conduit device 1 and systems of the present invention can also be used to establish and/or maintain conduits in a variety of tissue structures using minimally-invasive and/or invasive delivery techniques. Furthermore, while the embodiments of the invention described herein are directed to the thoracoscopic implantation of the conduit device to form at least one port for establishing an AAC, it should be understood that the system and/or vascular conduit device embodiments of the present invention may be used to establish valved and/or open conduits (including bypass conduits) to augment native blood vessels in order to treat a variety of vascular conditions including, but not limited to: aortic valvular disease, congestive heart failure, left ventricle outflow tract obstructions (LVOTO), peripheral arterial obstructions, small vessel obstructions, and/or other conditions. Furthermore, the vascular conduit device and system of the present invention may also be used to establish a port for inter
ventricular repairs such as, for example, valve repair and/or replacement or ablation procedures. Thus, the conduit device 1 described in further detail below may also comprise a threaded fluid-tight cap, and/or a cap having at least one pawl member (for engaging corresponding ridges defined on an outer surface of the conduit device 1) for selectively sealing a proximal end of the conduit device 1 such that the inner tube 40 thereof may serve as a re-usable port for repairing and/or treating diseased portions of the cardiac anatomy. Furthermore, the conduit device 1 and system embodiments of the present invention may also be used to implant a conduit and/or port for left ventricular assist devices.
In other embodiments, as shown generally in FIG. 7, the attaching device 15 may comprise a helical spring and/or coil having a substantially constant helical diameter as the attaching device 15 extends away from the distal end of the outer tube 10. The substantially consistent helical diameter of the attaching device 15 shown generally in FIG. 7 may be useful for operably engaging the outer tube 10 with a substantially flat tissue wall 850. Furthermore, as shown generally in FIG. 7, in some embodiments, the corresponding ring 30 (and the corresponding sealing member 35 that may be operably engaged therewith) may also be configured to provide a substantially flat and/or disc
shaped sealing surface that may be suitable for seating on and/or establishing a substantially fluid-tight seal with a substantially flat first tissue surface 855 that may surround an aperture defined in a correspondingly flat tissue wall 850.
1. A system for sutureless anchoring onto a ventricular wall, the system comprising:
an attaching device configured for advancing along a helical path at least partially through the ventricular wall such that at least a portion of the attaching device becomes disposed substantially between a first surface and a second surface of the ventricular wall;
an inner tube configured for extending at least partially through the attaching device and the ventricular wall to establish fluid communication between the first surface and the second surface of the ventricular wall; and
a ventricular assist device attached to the attaching device;
wherein the attaching device and the inner tube are configured to compress at least a portion of the ventricular wall between the attaching device and the inner tube.
2. The system of claim 1, wherein the attaching device comprises a coil or a spring member.
3. The system of claim 2, wherein the coil or the spring member comprises a radially-expanding helix shape.
4. The system of claim 1, wherein the attaching device is configured to compress at least a portion of the ventricular wall inward towards an aperture extending from the first surface to the second surface of the ventricular wall.
5. The system of claim 1, further comprising a ring configured for placement against the first surface of the ventricular wall.
6. The system of claim 5, wherein the ring comprises a frusto-conical shape.
7. The system of claim 5, wherein the ring is positioned about the attaching device.
8. The system of claim 5, wherein the ring is configured for receiving at least a portion of the first surface of the ventricular wall.
9. The system of claim 5, wherein the ventricular assist device is attached to the attaching device via the ring.
10. The system of claim 1, further comprising a valved conduit.
11. The system of claim 1, further comprising a sealing element configured for sealing against the first surface of the ventricular wall.
12. The system of claim 11, wherein the sealing element is configured for positioning about an aperture extending from the first surface to the second surface of the ventricular wall.
13. The system of claim 1, wherein the attaching device is configured to prevent peri-sheath bleeding around the inner tube.
14. The system of claim 1, wherein the ventricular assist device is attached to the attaching device via the inner tube.
15. The system of claim 1, further comprising an outer tube engaged with an approximate proximal end of the attaching device.
16. The system of claim 15, wherein the ventricular assist device is attached to the attaching device via the outer tube.
17. The system of claim 1, further comprising a cutting device configured for advancing through the attaching device and through the ventricular wall to define an aperture extending from the first surface and the second surface of the ventricular wall.
18. The system of claim 17, wherein the inner tube is configured for extending at least partially through the aperture defined by the cutting device, and wherein an outer diameter of the inner tube is greater than an inner diameter of the aperture.
19. The system of claim 18, wherein the attaching device comprises a coil or a spring member.
20. The system of claim 19, wherein the coil or the spring member comprises a radially-expanding helix shape.
21. The system of claim 17, wherein the cutting device comprises a coring member configured for coring a portion of the ventricular wall in defining the aperture.
22. The system of claim 21, wherein the cutting device further comprises an expandable element configured for removing the cored portion of the ventricular wall.
23. The system of claim 1, further comprising a cap configured for closing an aperture extending from the first surface and the second surface of the ventricular wall to block fluid communication between the first surface and the second surface of the ventricular wall.
24. The system of claim 23, wherein the cap is configured for removeably closing the aperture.
25. A system for securing in a ventricular wall having a first surface and a second surface, the system comprising:
an attaching device configured for advancing at least partially through the ventricular wall such that at least a portion of the attaching device becomes disposed substantially between the first surface and the second surface of the ventricular wall;
a cap configured for closing an aperture extending from the first surface to the second surface of the ventricular wall; and
a ring configured for placement against the first surface of the ventricular wall
wherein the attaching device comprises a coil or a spring member comprising a radially-expanding helix shape;
wherein the attaching device is configured to compress at least a portion of the ventricular wall inward towards the aperture.
26. The system of claim 25, wherein the coil or the spring member has a larger helical diameter at a distal end relative to a proximal end.
27. The system of claim 25, wherein the cap is configured for removeably closing the aperture.
28. The system of claim 25, further comprising a sealing element configured for extending about the aperture and sealing against the first surface of the ventricular wall.
US13845960 2007-04-24 2013-03-18 Conduit device and system for implanting a conduit device in a tissue wall Active US8858489B2 (en)
US11739151 US7846123B2 (en) 2007-04-24 2007-04-24 Conduit device and system for implanting a conduit device in a tissue wall
US12901810 US8430836B2 (en) 2007-04-24 2010-10-11 Conduit device and system for implanting a conduit device in a tissue wall
US13845960 US8858489B2 (en) 2007-04-24 2013-03-18 Conduit device and system for implanting a conduit device in a tissue wall
US14475068 US9308015B2 (en) 2007-04-24 2014-09-02 Conduit device and system for implanting a conduit device in a tissue wall
US15058703 US20160317793A1 (en) 2007-04-24 2016-03-02 Conduit device and system for implanting a conduit device in a tissue wall
US12901810 Continuation US8430836B2 (en) 2007-04-24 2010-10-11 Conduit device and system for implanting a conduit device in a tissue wall
US14475068 Continuation US9308015B2 (en) 2007-04-24 2014-09-02 Conduit device and system for implanting a conduit device in a tissue wall
US20130218169A1 true US20130218169A1 (en) 2013-08-22
US8858489B2 true US8858489B2 (en) 2014-10-14
US11739151 Active 2028-11-03 US7846123B2 (en) 2007-04-24 2007-04-24 Conduit device and system for implanting a conduit device in a tissue wall
US12901810 Active 2028-04-06 US8430836B2 (en) 2007-04-24 2010-10-11 Conduit device and system for implanting a conduit device in a tissue wall
US13845960 Active US8858489B2 (en) 2007-04-24 2013-03-18 Conduit device and system for implanting a conduit device in a tissue wall
US14475068 Active US9308015B2 (en) 2007-04-24 2014-09-02 Conduit device and system for implanting a conduit device in a tissue wall
US15058703 Granted US20160317793A1 (en) 2007-04-24 2016-03-02 Conduit device and system for implanting a conduit device in a tissue wall
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:YOGANATHAN, AJIT;JIMENEZ, JORGE HERNAN;REEL/FRAME:030183/0965