EP1408851A2 - Distal anastomosis system - Google Patents

Distal anastomosis system

Info

Publication number
EP1408851A2
EP1408851A2 EP20020749734 EP02749734A EP1408851A2 EP 1408851 A2 EP1408851 A2 EP 1408851A2 EP 20020749734 EP20020749734 EP 20020749734 EP 02749734 A EP02749734 A EP 02749734A EP 1408851 A2 EP1408851 A2 EP 1408851A2
Authority
EP
Grant status
Application
Patent type
Prior art keywords
graft
fitting
collar
connector
segment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20020749734
Other languages
German (de)
French (fr)
Inventor
Mitchell C. Barham
Sidney D. Fleischman
David P. Knight
Charles S. Love
Alexander Q. Tilson
James G. Whayne
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Converge Medical Inc
Original Assignee
Converge Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0206Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with antagonistic arms as supports for retractor elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0643Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0644Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30Surgical pincettes without pivotal connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B2017/0237Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for heart surgery
    • A61B2017/0243Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for heart surgery for immobilizing local areas of the heart, e.g. while it beats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135End-to-side connections, e.g. T- or Y-connections

Abstract

Distal anastomosis devices and associated methodology are described herein. Connector (2) and connector components as well as tools associated therewith are disclosed. The connectors (2) are preferably adapted to produce an end-to-side anastomosis at a graft/coronary artery junction. A fitting (10) alone, or a fitting (10) in combination with a collar (12) may be used as a connector (2). Each fitting (10) may be deployed by deflecting its shape to provide clearance for a rear segment (18) that rotates about adjoining hinge section (s) (28) so to fit the connector within an aperture formed in a host vessel. Upon return to a substantially relaxed position, a rear segment (18) anchors the interfacing with the host vessel/coronary artery. The collar (12) may include features complimentary to those of a fitting (10) and provisions for strain relief and securing the graft vessel.

Description

DISTAL ANASTOMOSIS SYSTEM

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional

Patent Application Serial No. 60/387,824 filed June 10, 2002; U.S. Patent Application

Serial No. 10/122,075 filed April 11, 2002, which claims the benefit of priority to

U.S. Provisional Patent Application Serial No. 60/333,276 filed November 14, 2001;

U.S. Patent Application Serial Number 09/991,469 filed November 21, 2001, and to

U.S. Patent Application Serial No. 09/899,346 filed My 5, 2001; each of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION [0002] This relates to producing end-to-side anastomoses, particularly in communication with coronary arteries, the aorta, the subclavian, iliacs, femoral arteries, popliteal arteries, radial arteries, mammary arteries, mesenteric arteries, renal arteries, carotid arteries, cerebral arteries, or other tubular structures. Accordingly, distal anastomosis connectors and associated devices are disclosed.

BACKGROUND OF THE INVENTION [0003] Current techniques for producing anastomoses during coronary artery bypass grafting procedures involve placing a patient on cardiopulmonary bypass support, arresting the heart, and interrupting blood flow in order to suture, clip or staple a bypass graft to the coronary artery and aorta. However, cardiopulmonary bypass support is associated with substantial morbidity and mortality. [0004] This invention provides devices and methods to avoid bypass support by allowing for positioning and securing bypass grafts at host vessel locations without having to stop or re-route blood flow for extended periods of time, which is a condition of conventional sutured anastomoses. In addition, this invention mitigates risks associated with suturing, clipping or stapling the bypass graft to a host vessel. This may be accomplished, in part, by features adapted to avoid bleeding at graft attachment sites and preventing the host vessel from collapsing around the incision point. Further, the invention optionally provides features to improve blood flow within a graft and increase the patency of a graft.

[0005] In performing cardiac bypass surgery, anastomosis sites are typically provided at a site along a patient's aorta, and another site along a coronary artery beyond a partial or complete occlusion. Alternatively, sequential "jumper" grafts may extend from a main bypass graft to individual coronary artery host vessels thereby requiring a single aortic anastomosis to accommodate multiple coronary anastomses. As such, in-flow anastomoses are required along the main "feeder" graft and out-flow anastomoses are required to the host vessel coronary arteries. This eliminates the need for side-side anastomoses between a single graft and multiple coronary arteries when producing sequential anastomoses from a single aortic anastomosis. Producing an effective anastomosis along a coronary artery is particularly challenging. The outer diameter of a coronary artery where a distal anastomosis may be needed can range from between about 1 mm to about 4 mm in size. By way of comparison, the outer diameter of the aorta where a proximal anastomosis may be located ranges between about 20 mm and about 50 mm in size.

[0006] The relatively small size of the site for a distal anastomosis translates to greater difficulty in a number of ways. Basic surgical challenges are encountered in dealing with the smaller vasculature. Further, an interface issue is introduced. Often, particularly for connection with the smaller coronary arteries, a graft conduit will have a larger diameter than the host vessel. This may be due to the need for a larger diameter conduit to carry adequate blood flow or the result of using a saphenous vein which must be oriented so its valving allows blood to readily flow in the desired direction from the proximal anastomosis to the distal anastomosis, thereby orienting the larger end of the graft toward the distal site. For whatever reason, the mis-match in size in joining the graft to the coronary artery must be addressed. The angled anastomotic junction created by the connector embodiments of the invention accommodate this mis-match in ratio between the host vessel and graft inner diameters.

[0007] The present invention is adapted to handle these issues as well as others as may be apparent to those with skill in the art. The distal-type connectors described herein may be employed with precision and speed, resulting in treatment efficacy not heretofore possible. SUMMARY OF THE INVENTION [0008] The invention includes various improvements in end-side anastomosis systems. Particularly, connectors for producing distal anatomoses are described. They each include a fitting comprising a rear or heel section with a trailing segment that is deflectable about a hinge region to allow for placement and securing the device. Curvilinear side and forward- facing portions are preferred. Most preferably, these portions are configured to conform to the shape of a host vessel and direct the opening (incision) through the host vessel to assume the shape defined by the fitting. Such a fitting may alone serve as a connector between a host vessel and a graft. Alternately, the connector may comprise a fitting in combination with a collar adapted to secure a graft to the fitting and optionally compress the graft and host vessel. [0009] Various features for improving the deployability of a connector, hemostasis at the connector to host vessel interface, and blood flow through the anastomoses may be provided by the invention. Further, various tools for use in preparing for and creating an end-side anastomosis may comprise part of the invention. Finally, various instruments and accessories decreasing the access to deploy the connector to enable minimally invasive surgical approaches may comprise at least part of the invention.

[0010] While connectors and deployment devices according to the present invention are preferably used in peripheral and coronary artery bypass grafting procedures, particularly at a distal (out- flow) or proximal (in-flow) location, it is to be understood that the systems described herein may be used for purposes other than creating artery-to-artery or vein-to-artery anastomoses. The systems may also be used to produce anastomoses between bypass grafts and host vessels to treat other occlusions, vascular abnormalities such as stenoses, thromboses, aneurysms, fistulas and other indications requiring a bypass graft. The system of the present invention is also useful in bypassing stented vessels that have restenosed, and saphenous vein bypass grafts that have thrombosed or stenosed. Further, the invention may have other applications, such as producing arterial to venous shunts or fistulas for hemodialysis, bypassing lesions and scar tissue located in the fallopian tubes causing infertility, attaching the ureter to the kidneys during transplants, and treating gastrointestinal defects (e.g., occlusions, ulcers, obstructions, etc.), among others. [0011] The present invention variously includes the devices as well as the methodology disclosed. Furthermore, it is contemplated that sub-combinations of features, especially of the connector features disclosed, comprise aspects of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS [0012] Each of the following figures diagrammatically illustrates aspects of the present invention. The illustrations provide examples of the invention described herein. Like elements in the various figures often are represented by identical numbering. For the sake of clarity, some such numbering may be omitted.

[0013] Figure 1 shows a side view of an installed fitting.

[0014] Figure 2 shows a side view of another installed fitting, this connector including a collar for securing the graft shown to a fitting.

[0015] Figures 3 A and 3B show side and end views of a fitting as may be used according to that shown in Figures 1 and 2.

[0016] Figures 4A and 4B show side and end views of a collar as may be used according to that shown in Figure 2.

[0017] Figure 5 shows a side view of an installed connector with a collar that secures a graft to the connector and affixes the connector and graft assembly to a vessel wall.

[0018] Figure 6 shows a side-sectional view of the installed connector and collar in Figure 5.

[0019] Figures 7a and 7b show side and isometric views of a formed connector as may be used according to that shown in Figures 5 and 6.

[0020] Figures 8a and 8b show side and isometric views of a variation of the formed fitting as may be used according to that shown in Figures 5 and 6.

[0021] Figures 9a and 9b show side and top views of a variation of the formed collar as may be used according to that shown in Figures 5 and 6. [0022] Figures 10a and 1 Ob-show side and top views of the collar in Figures

9a and 9b deflected using an external force during deployment.

[0023] Figures 11a and 1 lb show bottom views of two fitting variations thermally formed to accommodate different graft to host vessel inner diameter ratios.

[0024] Figures l ie and lid show bottom views of two collar variations, along with the fitting embodiments in Figures 11a and 1 lb, that accommodate different graft to host vessel inner diameter ratios.

[0025] Figures 12a to 12c show side views of graft vessels as they may be prepared.

[0026] Figure 13a shows an oblique view of a guide tool for preparing a graft vessel.

[0027] Figure 13b shows a panel of measurement grafts useful to determine an appropriate length for the graft vessel to be prepared.

[0028] Figures 14a to 14c show oblique, top and bottom views of a connector fitting variation at an intermediate stage of manufacture.

[0029] Figures 15a and 15b, 16a and 16b, and 17 to 20 show projected views of optional fitting features.

[0030] Figures 21a and 21b, 22a and 22b, 23, 24a to 24c, and 25a and 25b show projected views of optional collar features. [0031] Figures 26a and 26b show side and perspective views of a non- formed connector blanks, which when formed may represent the connector in Figures 8a and 8b.

[0032] Figure 27 shows a flattened view of the connector in Figures 26a and

26b.

[0033] Figure 28 shows a flattened view of an alternative connector embodiment.

[0034] Figures 29a and 29b show side and perspective views of the non- formed connector in Figure 28.

[0035] Figure 30 shows a flattened view of another connector embodiment.

[0036] Figure 31a shows a flattened view of a collar embodiment.

[0037] Figures 31b and 31c show side and perspective views of the collar embodiment in Figure 31a.

[0038] Figures 32a and 32b show side and perspective views of another collar embodiment.

[0039] Figure 33 shows a flattened view of an alternative collar embodiment.

[0040] Figures 34a and 34b show top and side views of an alternative formed fitting embodiment that locates the toe flap of the graft against the interior surface of the host vessel. [0041] Figures 35a and 35b show top and side views of a formed collar embodiment that cooperates with the fitting embodiment in Figures 34a and 34b to secure a graft to a host vessel.

[0042] Figures 36a and 36b show a single-piece connector embodiment.

[0043] Figures 36c shows the hinge locations of the connector in Figures 36a and 36b.

[0044] Figures 36d and 36e show top and side views of the connector in

Figures 36a and 36b with a graft secured.

[0045] Figure 37 shows an oblique view of a variation on a spreader.

[0046] Figure 38 shows an oblique view of a variation on a stabilizer.

[0047] Figure 39a and 39b show side and top views of a spreader specifically adapted to open a collar.

[0048] Figure 40 shows an oblique view of another spreader adapted to open a collar.

[0049] Figure 41a shows a side view of an instrument variation with a head adapted to deploy a connector.

[0050] Figure 41b shows an alternate head configuration for the instrument in

Figure 41a, this head configuration adapted for deploying a connector while holding the instrument at a different angle.

[0051] Figure 41c shows a scissors-type head configuration that may be used with the handle portion of the instrument in Figure 41a. [0052] Figure 42a shows a connector ready for deployment, restrained in customized Rongeur clamp.

[0053] Figure 42b shows an oblique view of the top of a lower section of the instrument in Figure 42a.

[0054] Figure 42c shows an oblique view of the underside of an upper section of the instrument in figure 42a.

[0055] Figures 43a and 43b show side views of another instrument for deploying a connector, the instrument positioned in retracted and extended states, respectively.

[0056] Figure 44 shows a side view of components to form another instrument for deploying a connector.

[0057] Figure 45 shows an oblique view of a end portion for another instrument for deploying a connector.

[0058] Figures 46a and 46b show the components of a loading tool used to secure a graft between a fitting and a collar.

[0059] Figure 46c shows a perspective view of a loading tool base for use in securing a graft to the fitting and collar.

[0060] Figure 46d shows a perspective view of a pushing tool for use with the loading tool base of Figure 46c. [0061] Figures 47a to 47c show a side view, an end view, and a bottom view, respectively, of an alternative inner frame (fitting) cartridge component of a loading tool embodiment.

[0062] Figures 48a to 48d show an outer frame (collar) cartridge component of a loading tool embodiment.

[0063] Figure 49 shows an exploded view of the components of a loading tool embodiment that utilizes the inner frame cartridge in Figures 47a to 47c and the outer frame cartridge in Figures 48a to 48d.

[0064] Figures 50a and 50b show an exploded view and a detailed view of a deployment tool embodiment.

[0065] Figures 50c and 50d show side-sectional views of the deployment tool embodiment in Figures 50a and 50b.

[0066] Figures 51a and 51b show side views of the deflecting mechanisms of the deployment tool embodiment in Figures 50a to 50d in the released state and deflected state respectively.

[0067] Figures 52a and 52b show a perspective view and an end view of a repositioning tool.

[0068] Figures 53a and 53b show a perspective view and an end view of a removal/repositioning tool.

[0069] Figures 54a and 54b show a perspective view and an end view of a removal tool. DETAILED DESCRIPTION OF THE INVENTION [0070] The variations of the invention discussed herein are applicable to robotic surgery, endoscopic, and other less invasive (i.e., minimally invasive) surgery. As noted above, the present invention includes variations of anastomosis connectors having features adapted to perform distal anastomoses. Anastomotic connectors, tools and associated methodology for producing in-flow (proximal) and out-flow (distal) anastomoses are described variously in, e.g., U.S. and foreign patent and applications entitled, "Percutaneous Bypass Graft and Securing System", U.S. Patent No. 5,989,276; "Percutaneous Bypass Graft and Securing System", U.S. Patent No. 6,293,955; Percutaneous Bypass Graft Securing System", PCT Publication No. WO 98/19625; "Sutureless Anastomosis Systems", U.S. Patent Application Serial No. 09/329,503; "Sutureless Anastomosis Systems", PCT Publication No. WO 99/65409; "Thermal Securing Anastomosis Systems" U.S. Patent No. 6,361,559; "Thermal Securing Anastomosis Systems", PCT Publication No. WO 99/63910; "Aortic Aneurysm Treatment Sytems", U.S. Patent Application Serial No. 09/329,658; "Aortic Aneurysm Treatment Systems", PCT Publication No. WO 00/15144; "Additional Sutureless Anastomosis Embodiments", U.S. Patent Application Serial No. 09/654,216; "Anastomosis Systems", U.S. Patent Application Serial No. 09/730,366; "End-Side Anastomosis Systems", PCT Pubhcatioin No. WO 01/416653; "Advanced Anastomosis Systems", U.S. Patent Application Serial No. 09/770,560; "Distal Anastomosis System", U.S. Patent Application Serial No. 09/899,346; "Distal Anastomosis System", U.S. Patent Application Serial No. 09/991,469; "Anastomosis Sytem", U.S. Provisional Application Serial No. 60/333,276; and "Sutureless Anastomosis System Deployment Concepts", U.S. Patent Application Serial No. 09/927,978 and applications and patents claiming benefit hereto, all of which are incorporated herein by reference in their entirety and all commonly owned by Converge Medical, Inc.

[0071] Figures 1 and 2 show distal anastomoses (2) formed by connectors (4) according to the present invention. Each connector (4) attaches a graft (6) to a host vessel (8). The host vessel may be any vessel or tubular structure to which a graft or other tubular structure is secured. During Coronary Artery Bypass Grafting (CABG) surgery, the host vessel is a coronary artery (Left Anterior Descending Artery, Diagonal, Circumflex, Obtuse Marginal, Right Coronary Artery, PDA, etc.), ascending aorta, subclavian artery or other vessel capable of bypassing an obstruction or stenosis by functioning as an in-flow or out-flow anastomotic junction. During Peripheral Grafting surgery, the host vessel is a popliteal artery, femoral artery, iliac artery, the aorta, carotid artery, radial artery, renal artery, hepatic artery, mesenteric artery, cerebral artery, saphenous vein, femoral vein, or other vessel that participates in bypassing an obstruction or stenosis by functioning as an in-flow or out-flow anastomotic junction. For CABG and peripheral vascular procedures, the graft (6) comprises an autologous vessel such as a saphenous vein, radial artery, left internal mammary artery, right internal mammary artery, other tissue (e.g. pericardium, submucosal, etc.) formed into a tubular structure, a synthetic graft (such as expanded PTFE or urethane derivatives), a genetically produced vessel, a donor vessel, or other tubular structure. In addition, one anastomoses' graft may function as another anastomoses' host vessel where connector are also used as in-flow anastomotic junctions to produce a series of jumper connections from a main graft to several spaced apart target conduits.

[0072] Referring to figure 1, various features of fitting (10) may be observed.

First, it is noted that fitting and attached graft (6) are preferably configured so its base or body (14) is at an angle with respect to host vessel (8). Connectors (2) are shown at approximately a 30° angle. Preferred angles for distal anastomosis range from about 20° to about 70°. A more preferable range is from about 25° to about 45°. More preferably, they are between about 28° and about 30°. Because of the design of' the connector, the angle helps maintain hemostasis and optimize blood flow once the anastomosis is created and retracted organs and tissue bear upon the site. Pressure created by such action will not dislodge connector (4) or kink or collapse graft (6) since the connector allows the graft (6) to extend at an acute angle such that the graft closely apposes the host vessel and lies substantially in line with the host vessel and adjacent anatomy. In addition to improving blood-carry capability of the conduit in assuring stability of the connector, including some angle in the connector enables the manner of deployment and attachment taught below. [0073] Fitting (10) may include at least a front or leading segment (16) and a rear or trailing segment (18). When situated to form an anastomosis, these segments preferably lie approximately in line with host vessel (8). So-placed, they prevent removal of the connector from the host vessel. Optional lateral or side portions (20) may also aid in this regard. This is especially the case when forming an anastomosis with a very small diameter vessel (such as a 1 to 4 mm diameter coronary artery). Furthermore, lateral portions (20) may assist in providing a physical barrier to leakage. This may be true irrespective of the size of host vessel (8). The use of one or more lateral portions (20) on each side of fitting (10) may also provide a smooth transition between the leading and trailing portions of fitting (10) to help moderate or alleviate trauma to the interior of the host vessel (8). Also, lateral portions (20) are also preferably configured such that they allow fitting (10) to flex with the wall of host vessel (8). For instance, as the heart pumps blood through the vascular system, host vessel (8) may move or undulate with the pumping action of the heart; accordingly, fitting (10) may also move or flex in part by lateral portions (20) with the natural motion of the vessel (8). The front or leading segment (16) may have a rounded toe-like configuration to also facilitate entry of the fitting (10) into the opening within the wall of the host vessel (8).

[0074] A lateral portion may be provided integrally with a form providing at least part of leading segment (16). Alternately, or additionally (as shown in figure 3 A), lateral portions (20) may be provided in discrete form. Especially when pushed toward the rear of fitting (10), such a member will work in conjunction with rear segment (18) to maintain hemostasis at connector (4). Furthermore, lateral portions (20) not only provide a smooth transition extending between the leading "and trailing portions of fitting (10), but they are configured to minimize the contact area with the inner surface of host vessel (8). The total contact area in which fitting (10) engages the host vessel (8) inner wall is preferably no greater than 5% to 35% of the inner surface area of fitting (10) against host vessel (8).

[0075] Additional optional features of fitting (10) include tabs (22) to assist in securing graft (6) and/or optional collar (12). Such tabs may be oriented to grip graft (6) as shown in figure 1. One or more tabs may also be adapted to form a locking interface with one or more complementary tabs (24) optionally included in collar (12). Also, the height or amount of material incorporated in the base of the fitting may be varied. In order to utilize as little material as possible to join the various segments, base (14) may be provided by a narrow band of material as shown in Figure 3 A, 14A- 14C or otherwise. To achieve proper relative placement of these features, base (14) may be curved or undulate.

[0076] As shown in Figure 3B, the connector opening (26) may have a circular bore; alternately, it may be ovalized . As described in further detail below, configuring fitting (10) with an ovalized opening (26) may be useful in providing an interface at a smaller host vessel. It provides a manner in which to account for the size difference between the vessel and what is often a larger opening of the graft by transitioning the diameter between the openings. The ovalization increases the available perimeter to accommodate a host vessel without increasing the lateral size of the connector. Instead, a connector may be lengthened. This will usually be an acceptable alteration in connector geometry since only the size of the arteriotomy made in the host vessel need be lengthened to fit the connector in place. [0077] Features that are preferred of fitting (10), in addition to the basic leading and trailing segment configuration, are found in connection with a hinge section (28), as shown in Figures 1, 6, 7a, 7b, 8a, 8b, 34a, 34b, 36a, and 36b. Hinge section (28) may be provided in a number of configurations. However, the configurations serve the same purpose. Each of the variations shown and described allow rear or trailing segment (18) to be displaced sufficiently to clear the host vessel wall for insertion of the connector into the host vessel by significant torsional deflection of areas between rear segment (18) and fitting body (14). In the fitting variations shown in Figures 1, 3a, 3b, 6, 7a, 7b, 8a, and 8b, a pair of torsion sections (30) are presented on each side of rear segment (18). In the variation in Figures 14a- 14c, hinge section (28) includes only one torsion section (30) on each side of rear segment (18).

[0078] To displace rear segment (18) of Figure 1 sufficiently, the primary deflection does not occur at bend (32) as with the distal connectors described, e.g., in U.S. and foreign patents and applications entitled, "Improved Anastomosis Systems", U.S. Patent Application Serial No. 09/730,366; "End-Side Anastomosis Systems", PCT Publication No. WO 01/41653; "Advanced Anastomosis Systems (II)" U.S. Patent Application Serial No. 09/770,560. Rather, rotation about torsional sections accounts for at least half, if not most or substantially all of the displacement required of rear segment (18). In the variation of the fitting shown in Figures 14a-14c. In the variation of the fitting shown in Figures 14a-14c, rotation of rear segment (18) occurs about the pair of torsional members (30), whereas in the variations, e.g., in Figures 1, 3a, and 3b, the rotation that occurs is shared between two pair of torsional sections. [0079] Such dual action provides for certain advantages notable in the variations shown in Figures 1, 3 a, and 3b. Namely, upon forward deflection of rear segment (18), the lateral portions connected to torsional sections are caused to be drawn or flexed inward. This action facilitates introduction of connector (4) into host vessel (8) by clearing portions that could otherwise interfere with entry. [0080] In the variation of the invention shown in Figure 1, it may be observed that the torsional regions may be provided either by a wire segment or simply by a portion of the base of the fitting reduced to a relatively narrow section by a feature such as a cut, break, groove or slit (34) in the material. In the variation shown in Figures 14a- 14c, no marked reduction in size relative to another portion of the fitting base is apparent.

[0081] For fittings configured similarly to that in Figures 14a-14c, it is also noted that rotation of members (30) in deflecting rear section forward will cause lateral portions (20) to be drawn inward to some extent. However, the amount of inward deflection will be less relative to the variations of the fitting shown in figures 1 and 3 A and 3B where lateral portions (20) are directly connected to torsional sections.

[0082] Figures 5 and 6 show another variation of the fitting. In this variation, a lateral portion is provided integrally with a form providing at least part of leading segment (16) and trailing segment (18). This continuous coverage helps to ensures complete tissue capture between the fitting (10) inside the host vessel and the collar (not shown) outside the host vessel. Complete coverage ensures hemostasis at the vessel to graft interface.

[0083] In the further variation as shown in Figures 8a and 8b, lateral portions

(20) may extend beyond the plane of the trailing segment (18) and interconnect with the leading segment (16) to ensure the host vessel tissue about the opening through the host vessel is completely captured around the anastomosis thereby ensuring a physical barrier to leakage. Also having one or more lateral portions (20) on each side of the fitting (10), in this variation, also provides a smooth transition between the leading and trailing portions of fitting (10) to facilitate insertion of the connector through an opening in the host vessel and help moderate or alleviate trauma to the interior of the host vessel (8) while deploying the connector. [0084] The connector in Figures 5 and 6 may be utilized as an out-flow anastomotic junction where blood passes through the graft, past the connector, and into the host vessel where it is capable of flowing antegrade and retrograde. Alternatively, the connector in Figures 5 and 6 may be utilized as an in-flow anastomotic junction where blood passed through the host vessel, past the connector, and into the graft.

[0085] The optional features of fitting (10) shown in Figures 6, 8a, and 8b may also include tabs or latches (22) to assist in securing graft (6) and or optional collar (12), as described above. Furthermore, the height or amount of material incorporated in the base of the fitting may likewise be varied. [0086] As shown in Figures 7b and 8b, the connector opening (26) may have an ovalized or elliptical opening to the anastomosis or it may have a circular bore. As will be discussed below, the connector is preferably fabricated from a raw tube that is laser cut into the desired pattern and thermally formed into the desired resting configuration as shown in Figures 7a, 7b, 8a and 8b. This inherent profile may be altered by closing the width between opposite sides of the lateral portions (20) and/or base (14) causing the connector to assume an ovalized profile with the major axis extending from the leading segment (16) towards the trailing segment (18) and the minor axis perpendicular to the major axis, as shown further in Figure 11a. Configuring fitting (10) with an ovalized opening (26) may be useful in providing an interface to a smaller host vessel. As shown in Figure 11a, ovalizing the profile at the lateral portions (20) to a width, Al, while maintaining the profile of the base (14) to a width, Bl, provides a manner in which to account for the optimal transition in the size difference between a smaller diameter host vessel and what is often a larger diameter opening of the graft by transitioning the geometry change from the ovalized anastomotic junction cross-section to the more circular graft cross-section. In this

case Al ≤ Bl. For example, a 30 degree, 3 mm connector having Bl = 0.117" and Al

= 0.110" is capable of transitioning a graft with an inner diameter from 3 mm to 5 mm to a host vessel with an inner diameter from 2 mm to 4 mm. A 30 degree, 3 mm connector having Bl = 0.117" and Al = 0.080" is capable of transitioning a graft with an inner diameter from 3 mm to 5 mm to a host vessel with an inner diameter from 1.25 mm to 2.5 mm. The ovalization increases the available perimeter to accommodate a host vessel without having to alter the diameter of the connector. Instead, a connector is lengthened by ovalizing to accommodate smaller host vessels without having to change the diameter of the base and/or graft. Ovalizing the connector is an acceptable alteration in connector geometry since only the size of the arteriotomy made in the host vessel need be lengthened to fit the connector in place. [0087] The angled connector geometry provides a further enhancement in that a single version accommodates a wide range of graft diameters. By angling the graft relative to the host vessel, the cut end of the graft, which defines the graft toe (48) and the angle the graft extends from the connector may be modified to produce a cross- section that matches the specific connector size.

[0088] As shown in Figure 1 lb, the separation between the lateral portions

(20) of the fitting (10) may be increased, A2, such that it exceeds the diameter, B2, of the base (14) to enable transitioning a larger diameter host vessel to a smaller diameter graft. This is particularly relevant when using the angled connector as an inflow anastomotic junction between a large vessel (such as the aorta, iliac, subclavian, carotid artery, femoral artery, or other supplying vessel) and a smaller diameter graft. [0089] As shown in Figures lie and lid, the collar profile matches that of the fitting to accommodate for the disparity in size between the host vessel and graft, if any. The collar of Figure 6c matches the profile of the fitting embodiment in Figure

11a such that A3 < B3 to apply compression against the host vessel and graft when the host vessel diameter is equal to or smaller than the diameter of the graft. Similarly, the collar of Figure lid matches the profile of the fitting embodiment in Figure 1 lb such that A4 > B4 to accommodate larger host vessel diameters compared to the graft.

[0090] h this variation, displacement of the rear segment (18) occurs by rotation about torsional sections, which may account for a substantial amount of the displacement required of trailing segment (18). The additional displacement may arise from bending of the trailing segment (18) relative to the junction between the trailing segment and the torsional sections. In the variation shown in Figures 28, 29a, and 29b, rotation of rear segment (18) occurs about the pair of torsional members (30), whereas in the variations in Figures 6, 7a, and 7b, the rotation that occurs is shared between two pair of torsional sections.

[0091] In addition, the inherent design of the embodiment in Figures 6, 7a, and 7b may require a pair of torsional sections on each side of the trailing section, one integrated with the base (14) and an opposite extending one integrated with the leading section (16). The embodiment in Figures 6, 7a, and 7b has the trailing section (18) cut from the base (14) and deflected approximately 30 degrees in its resting configuration. This is highlighted by the difference in shape between the laser cut manufacturing step shown in Figures 26a and 26b and the thermally formed configuration shown in Figures 7a and 7b. As such, the trailing section (18) may be integrated with the base and the leading section to provide a continuous band of support throughout the anastomosis along the interior surface of the host vessel, increase the resistance to deflection, once the connector is deployed, and providing a wedge between the trailing section (18) and the base (14) capable of increasing the compression forces that the trailing section (18) and the base (14) exert against the graft and the host vessel to ensure hemostasis at the heel of the anastomosis. [0092] For fittings configured similarly to that in Figures 29a and 29b, it is also noted that rotation of members (30) in deflecting rear section forward may cause lateral portions (20) to be drawn inward to some extent. However, the amount of inward deflection may be less relative to the variations of the fitting shown in Figures 6, 7a, and 7b where lateral portions (20) are directly connected to torsional sections. [0093] The embodiment in Figures 34a, 34b, 36a, and 36b similarly has the trailing section (18) cut from the direction of the base (14) however, the base in this embodiment has been shortened and extends from just adjacent to the trailing segment (18) to the leading segment (16). Therefore, the trailing section (18) still provides a continuous band of support throughout the anastomosis but the base does not inhibit the ability to extend the graft at a more acute angle than 28 to 30 degrees. [0094] Turning now to the features of collar (12), Figures 2, 4a, 4b, 5, 9a, 9b,

10a, 10b, 31a, and 31b illustrate features of this part of connector (4). One purpose of collar (12) is to secure graft (6) and host vessel to fitting (4) and ensure the graft produces a gasket against the host vessel throughout the periphery of the anastomosis to ensure hemostatis, particularly in the variation of Figure 5. As noted above, optional collar tab(s) or latch(es) (24) may assist in this regard by interfacing with optional fitting tab(s) or latch(es) (22). Also, collar (12) may be made to be resihently biased against graft (6) and host vessel to hold it to fitting (10). Further, interlocking members (36), such as that shown in Figures 2 and 4a, may be provided to ensure a secure fit of collar (12) about fitting (6). One or more of these interlocking members may take the form of a hook as shown in Figure 4a. Provision of a latching mechanism (36) also eliminates any perceived need to use a locking member such as a retaining clip, suture, implantable clips, staples, or other device that might be desired to ensure graft (6) is secured to fitting (4).

[0095] Collar (12) may comprise at least a proximal band (38) and a distal band (40). One or more intermediate bands or band segments (42) may also be provided, upon which optional tabs (24) may be mounted. [0096] In the variations of connector (12) shown in Figures 2, 4a, and 4b, lateral portions (44) are also provided. Preferably, they overlap or interface with corresponding lateral features (20) of a complimentary fitting (10) to form a complete seal at an anastomosis site. Likewise, the shape of the bore of the collar as shown in Figure 4b should complement that of the fitting. In instances where the fitting has a circular bore (26) as shown in Figure 3b, at least a mating portion of collar (12) should be substantially circular as well. In instances where fitting bore (26) is ovalized, a corresponding shape should be utilized in collar (12). [0097] Figure 42a shows another collar (12) in combination with a fitting (10).

In this collar, the band portions attach to opposite rib segments (46) at the rear of collar (12). No lateral portions as shown in the above-referenced figures are included in this type of fitting. This type of collar functions well with fitting like those shown in Figure 1, that only include a pair of lateral portions (20), instead of two pair like the connectors shown in Figure 3 a and 14A-14C.

[0098] In addition to the collar bands forming part of a structure to help secure graft (6) to fitting (4), at least the proximal and distal bands (38) and (40) may provide additional utility, as shown in Figure 2. Proximal band (38), possibly in connection with adjacent portions of collar (12) may be configured to provide a graft/connector transition allowing for greater blood flow and/or preservation of the character of a graft, particularly a saphenous vein graft.

[0099] When exposed to arterial blood pressure, saphenous veins may balloon, producing turbulent flow adjacent to the anastomosis site. This may lead to hyperplasia or other unwanted physiologic abnormalities. This tendency is exacerbated by any abrupt transition in stiffness along its length. Avoidance of ballooning mitigates the physiologic risks and also ensures a better flow profile within graft (6).

[0100] To reduce the tendency for a saphenous vein graft to balloon, proximal band (38) may be of a lower stiffness than adjacent bands. It is also preferable that it have a curvilinear shape like that depicted in Figures 2 and 4a. Alternately, it may follow a substantially straight line as viewed from the side as depicted in Figure 42a. Either way, it is preferred that band (38) not run a circumference perpendicular to graft (4). By setting band (38) askew or by utilizing an undulating form, graft (4) does not suddenly lack support about an area in which it may easily balloon. [0101] As for distal band (40), it may be used to help form a heriiostatic seal between host vessel (8) and graft (6) and/or connector fitting (10). Preferably, band (40) is designed to bear down upon a toe portion (48) of graft (6) once inserted into a host vessel (8). Also, it may be set to bridge any gap between graft (6) and host vessel (8). Either way, band (40) should grip graft (6) to ensure its proper location. Such interaction may be aided by the inclusion of undulating or serrated gripping features (50) in distal band (40).

[0102] In order to insert connector (4) to complete an anastomosis, it is preferred that distal band (40) be flexible. In inserting a connector according to the present invention including a fitting (10) and collar (12), it is preferably manipulated as shown in Figure 42a. Here, a modified Rongeur clamp (52) is shown retracting band (40) and advancing distal segment (18) to prepare the connector for insertion into an opening in a coronary artery or other appropriate site. Instrument (52) includes an upper finger (54) and a lower finger (56), each with relieved' interface sections (58) and (60) to accommodate band (40) and rear segment (18), respectively. Rear segment (18) extends beyond lower finger (56) to allow visualization to assist in insertion within host vessel (8).

[0103] The variations of collar (12), as shown in Figures 5, 31a, 31b, 9a, 9b,

10a, and 10b further show expansion spring members (35) which may be provided to enable expanding the diameter of the collar for placement around the fitting and returning the collar towards its preformed configuration once positioned to ensure a secure fit of collar (12) about fitting (6). The expansion spring members (35) in the embodiment in Figures 5, 31a, and 3 lb may incorporate a vertical undulating pattern which enlarges as the collar is expanded from its resting diameter towards an enlarged geometry and urges. Once the external force enlarging the collar is removed, the expanding spring members may recoil towards the undulating pattern urging the collar towards its resting, smaller diameter configuration. Figure 33 shows an alternative expansion spring member (35) which involves a horizontal undulating pattern. In this embodiment, enlargement of the expansion spring member (35) causes the central piece to deflect towards the base (14) of the fitting ensuring the collar maintains contact with the fitting despite enlargement or other deflection of the collar. This may become effective when the collar is deflected during deployment which may cause slight expansion of the collar to ensure separation between the collar components and the fitting during insertion into the host vessel, as will be discussed below. Provision of expansion spring members (35) eliminates any perceived need to use a locking member such as hook interlocking mechanism, a retaining clip, suture, implantable clips, staples, or other device that might be desired to ensure graft (6) is secured to fitting (4).

[0104] The variation of the expansion spring members (35) as shown in the

Figures 5, 9a, 9b, 10a, and 10b incorporate a vertical undulating pattern, which enlarges as the collar is expanded from its resting diameter towards an enlarged geometry. This expansion spring configuration has a middle undulation and two side undulations. The length of the middle undulation is shorter than that of the side undulations (approximately XA to XA shorter), and the widths and wall thicknesses are the same so enlarging the expansion spring first separates the side undulations without altering the middle undulation and only after substantial enlargement of the side undulations does the middle undulation separate. This helps orient the trailing segment (18) of the fitting (4) relative to the expansion spring (35) while loading the fitting and graft to the collar. Another alignment feature shown in Figures 9a, 9b, 10a, and 10b are short protrusion extending from the junction between the side undulations and the middle undulation that orients the trailing segment (18) relative to the expansion spring (35) and maintains that orientation during manipulation of the connector. [0105] This expansion spring embodiment also enables lengthening the distance from the tab or latch (24) of the collar and the location on the expansion spring to which the trailing segment of the fitting abuts. This facilitates securing the collar to the fitting around the graft by locating the tab (24) of the collar beyond the tab (22) of the fitting without having to engage and dramatically pull tab (24) past the tab (22). Upon releasing the external force deflecting the collar, the expanding spring members recoil towards the undulating pattern urging the collar towards its resting, smaller diameter configuration thereby engaging the tab (24) of the collar to the tab (22) of the fitting and compressing the collar against the base (14) of the fitting. [0106] Preferably, the variation of distal band (39), as shown in Figures 5, 9a,

9b, 10a, 10b, 1 lc, 1 Id, 31a to 33, 35a, and 35b, of the collar (12) extends completely around the anastomosis from the heel to the toe to overlap or interface with corresponding lateral features (20) of a complimentary fitting (10) to form a complete seal at an anastomosis site. Likewise, the shape of the bore of the collar preferably complements that of the fitting. For example, the shape of the bore of the collar shown in Figures l ie and lid should complement that of the fitting shown in Figures 11a and 1 lb, respectively. In instances where the fitting has a circular bore (26), at least a mating portion of collar (12) is preferably substantially circular as well. In instances where fitting bore (26) is ovalized, a corresponding shape is preferably utilized in collar (12). For instances where the fitting is tapered in geometry from a circular profile at the graft to an ovalized or enlarged profile at the anastomotic junction, the collar should also possess such features. The distal band (39) is secured to the base of the collar at the heel to enable deflecting the distal band (39) upward during deployment, e.g., as shown in Figure 10a. The semicircular nature of the distal band (39) may cause the distal band to buckle outward as it is deflected with a deployment tool, e.g., as shown in Figure 10b. This provides separation between the distal band (39) and the lateral sections (20) of the fitting to ensure host vessel tissue can enter this gap such that once positioned, the distal band may be released thereby compressing the graft and the host vessel against the fitting leading section and lateral section ensuring complete hemostasis around the periphery of the anastomosis. [0107] Another feature of the collar (12) embodiment as shown in Figures 5,

31a-31c, 5, 9a, 9b, 10a, and 10b involves side spring loops (33). These side spring loops (33) may serve dual purposes: they may enable axial extension of the tab (24) during loading of the collar over the graft and the fitting to enable placing the tab (24) of the collar into engagement with the tab (22) of the fitting without requiring significant manipulation of the fitting and collar. The side spring loops (33) may also provide an engagement point for pins of a deployment tool to stabilize the connector during deployment or a loading tool to manipulate the collar during placement of the graft and/or locking of the fitting to the collar. In the former, the side spring loops (33) may or may not be thermally formed in a radially outward configuration such that the deployment tool pins may be readily inserted from the top, front, or rear, depending on the location of the pins on the deployment tool. As shown in Figures 32a and 32b, the side spring loops (33) may alternatively be fabricated without a loop but with horizontal (or vertical) undulating members that straighten as the tab (24) is extended relative to the base of the collar.

[0108] Ears (37), shown in Figures 9a, 9b, 10a, and 10b provide an engagement point for pins of a deployment tool to stabilize the connector during deployment or a loading tool to manipulate the collar during placement of the graft and/or locking of the fitting to the collar. The ears may or may not be thermally formed in a radially outward configuration such that the deployment tool and/or loading tool pins may be readily inserted from the top, front, or rear, depending on the location of the pins on the deployment tool.

[0109] The collar embodiments in Figures 9a, 9b, 10a, 10b, 31a-31c, and 32a-

32b may also incorporate a grasping loop or link (31) that provides an exposed edge which the deployment tool may engage and deflect the distal band (39) relative to the base of the collar. The facilitates engagement and removal of the deployment tool relative to the collar.

[0110] Whether prepared in connection with a collar or not, connector (4) is preferably installed at an anastomosis site as shown in Figures 1 and 5. Here, it may be observed that graft toe (48) preferably overlaps host vessel (8). A heel portion (62) may abut, overlap host vessel (8) or leave a slight gap.

[0111] When connecting a graft to a small diameter host vessel, the graft toe

(48) preferably resides along the exterior surface of the host vessel so it doesn't substantially reduce the cross-sectional area of the host vessel. When a connector is provided with a collar (12), the visible result will resemble that in Figures 2 or 5. Still, one preferred relation of graft (6) to host vessel (8) remains similar' to that shown in Figures 2 or 5, depending on the fitting configuration selected. Alternatively, the graft toe (48) may be oriented such that it resides along the interior surface of the host vessel and the host vessel overlaps the graft toe. This is an especially suitable alternative when the connector is attaching a graft to a larger diameter host vessel. [0112] Figures 12a to 12c, illustrate graft preparation configurations. Graft

(6) shown in Figure 12a is configured like that shown in Figure 1. Graft (6) shown in Figure 12b differs by the inclusion of an "open" heel section (64); that in Figure 12c has "high" heel section (66). The open-heel configuration provides for graft side extensions (68) offering additional graft material to overlap a host vessel upon connector insertion. The high-heel configuration also provides additional graft material to overlap a host vessel upon connector insertion. By flexing heel (66) outward to form an increased angle, β, heel (66) it is able to overlap the host vessel above at least a portion of rear segment (18) upon connector (4) insertion. [0113] Figure 13a shows a die (70) with grooves (72) that may be used to guide a scalpel or other cutting instruments to trim a graft (6) placed within partial bore (74) to achieve any of the graft configuration shown in Figures 12a- 12c. For example, in preparing the graft end configuration shown in Figure 12b, a first cut is preferably made at a 45° angle to define the open heel (64). Then a 30° follow-up cut is made to define side portions (68). In preparing a graft as depicted in either of Figures 12a or 12b, it may also be desired to create a rear slit. This may be performed by taking the graft out of die (70) and manually cutting it with Potts scissors for a length up to about 4 mm to 10 mm. This allows for further advancement of graft (6) over fitting (10) to provide increased coverage.

[0114] A graft/connector combination with at least a distal connector (4) is preferably prepared before producing the arteriotomy into which this connector is preferably placed. In determining the appropriates size of connector (4) and length of graft, measurements are taken. The size of the connector depends on the size (particularly the diameter) of graft that is harvested or otherwise made available for use.

[0115] The length to which graft (6) should be cut may be determined by simply measuring the distance between anastomosis target sites. A preferred manner is, however, to take a measurement by reference to a group or panel (76) of measurement graft/connector members (78) such as shown in Figure 13b. Like a panel of different optics that an optician may use to determine the proper match for a patient, comparison of different members (78) provided in panel (76) to the relevant anatomy provides a physician with the ability to quickly and easily visualize and estimate the ideal graft length. The length of each unit is advantageously identified by printing upon each measurement members (78) or in connection with an optional container (80). Either way, utilizing measurement members (78) provides a much more accurate gauge of the proper length of a host vessel since each more realistically spans the distance between target sites. Most preferably, each member (78) conforms to anatomy and approximates the angle(s) at one or both anastomosis sites. [0116] To achieve such results, measurement members (78) preferably include a central section (82) adapted to model the compliance of a graft to be used. Each member also preferably includes an end (84) adapted to model the properties of a connector according to the present invention. The opposite end (86) of each member may be adapted to model a proximal anastomosis connector. A preferred manner of producing measurement members so-adapted or configured is with PTFE tubing ranging in diameter from about 2 mm to about 6 mm and a length between about 60 mm and about 150 mm together with actual connector members or pressed-in inserts (88). The inserts may be made of simple plastic pieces or otherwise. [0117] This being said, Figures 7a, 7b, 14a-14c, 26a, 26b, and 27 show views of a connector fitting (10) at different stages of production being made from tubing. Figure 27, for instance, shows the flattened profile of the tubing laser cutting to obtain the fitting blank. Figures 26a and 26b show the laser cut fitting blank and Figures 7a and 7b show the thermally formed fitting. The tube stock used to prepare distal connector fitting preferably has an outer diameter between 0.080 and 0.240 in (2 to 6 mm) and a wall thickness between 0.004 and 0.010 in (0.1 to 0.25 mm). Slightly larger diameter stock (or end product) will be used for each matching collar. The stock thickness for NiTi material used to form collars will typically have a wall thickness between about 0.004 in and about 0.010 in, and preferably between about 0.006 in and about 0.010 in.. Especially, for fitting (10) where it is possible to use thin stock in view of strength requirements, this will be preferred in order to minimally obstruct blood flow past the fitting. Larger connector components will typically be made of thick stock to account for increased stiffness required of such configurations relative to smaller ones.

[0118] In the piece shown in Figures 14a-14c, only rear segment (18) is show set in its final, formed position. As with the other elements, rear segment (18) is cut in the tubing and initially appears aligned with the other features. Then, a technician deflects the segment from its initial placement in accordance with the arrow associated with segment (18). To set each element in its pre-operative location, the material is stressed and held at the desired position while heated or thermally formed to set its shape. The degree of bend in rear segment show is so extreme as to require sequential deflectation and thermal forming steps. As for the other elements to be set in a deflected shape as indicated by arrows associated therewith, a single deflection/thermal-forming cycle is adequate.

[0119] Figure 15a and 15b show splayed out views of a fitting according to the present invention. In interpreting these figures and those similar to them for the collars, it need only be appreciated that each flattened form represents a pattern (144) for cutting tube or flat stock to be shaped into a fitting or connector. When fitting pattern (144) is cut in tubing, it completely wraps around the tube forming a seamless piece very similar to that in Figures 14a- 14c. When flat stock is used, another forming step is used to produce a round or ovalized body with which to work with. The ends of the body may then be joined. Alternately, any gap or split may be left open to provide a measure of especially compressibility in the fitting. What is more, it is contemplated that a gap or split may be foπned in a fitting made from tube stock to provide such compliance to connector.

[0120] One way in which a fitting according to pattern (144) in Figure 15a differs from that in Figures 14a-14c, however, is by relieved sections (146) in rear segment (18). This allows for relatively larger rear lateral portions (20). Fitting pattern (144) in Figure 15b includes similar features. It is further distinguished, however, by its smaller size suited for cutting into a smaller diameter tube (or in flat stock) to form a smaller connector (3.0 mm diameter in comparison to 3.5 mm diameter). Due to the smaller size, of the fitting, a substantially regular opening (26) is provided. In contrast, the variation in Figure 15a includes a nonlinear or irregular opening shape, similar to that shown in Figures 14a- 14c. This has been found to advantageously reduce the a wound-healing/hyperplastic response at the site. Each of the fitting patterns (144) in Figures 15a and 15b include various bands (148) and runners that provide a sort of latticework or wireform to give substance to the connector while minimizing material usage.

[0121] Figures 16a and 16b show patterns for connectors that are similarly constructed. In these, opening (26) becomes less regular as breaks in the base or body (14) of the fitting are observed. In a fitting made in accordance with Figure 16a, those breaks occur in connection with rear lateral portions (20) and at lead tab (22). The fitting pattern in Figure 16a also provides a tang (152) to grab the heel of a graft to assist in graft loading and/or placement. The switchback providing each of the lateral portions (20) not only assists in providing a non-circular or irregular shape to assist with issues of hyperplastic response, but also provides a measure of axial flexibility to a fitting including such a feature. The break in the base of the fitting at lead tab (22) provides a measure of radial compressibility to the fitting.

[0122] In the fitting variation shown in Figure 16b, a break at tab (22) is also provided. However, base (14) provides more complete support to elements around the fitting. The manner in which rear lateral portions (20) are attached to rear segment (18) is also worthy of note. As discussed variously above, such a configuration allows for actuation of lateral portions connected to the rear segment. Also, it provides a pair of torsional members (30) on each side of rear segment (18) around which to hinge.

[0123] Figures 17 and 18 show fitting patterns (144) with additional inventive features. A connector to be formed according to the pattern in Figure 17 will have a rear segment (18) that includes an enlarged end (154). The increased coverage of end (154) may provide a more secure connection or a relatively less traumatic interface with host vessel (8). However, unless finely tuned in size, enlarged end (154) can present clearance challenges in deployment. Likewise, a tight transition or outer band (156) from lead section (16) to forward side sections (20) may provide some impediment to introduction through an arteriotomy. A more preferred approach is shown in connection with figure 1 where a more gradual transition is made between lead segment (16) and side portions (20). Still, such a profile may be difficult to achieve in relatively large diameter connectors (i.e., on the order of 6 mm in diameter) such as shown in figure 19.

[0124] Regardless, it is noted that fittings as shown in Figure 1, 17, and 18 share a common feature in a relatively discrete front segment (16) as compared to other fittings shown herein. This may assist in connector penetration and dilation of an arteriotomy during insertion. A broader front section (16) as shown in Figures 15 a- 16b may, however, be more advantageous from the perspective of the hemostasis due to greater coverage area.

[0125] A fitting according to the pattern shown in Figure 18 includes further distinguishing characteristics. Here rear segment (18) originates in a different manner than shown in connection with the other fittings. In this instance, torsion sections (30) are not provided in connection with base (14) near opening (26) but are positioned adjacent lateral portions (20). Provided in this manner, no medial bend (32) or less bend in segment (18) is required to place rear segment end (154) in position to fulfill its task. In a fitting formed with a rear segment (18) oriented according to the approach in Figure 18, segment (18) may be flexed outward from the connector body and set in shape by thermal forming by a single cycle. To use the fitting, rear segment (18) is flexed backward rather than forward. Formation of the fitting in this manner provides advantages in that less stress is applied to rear segment (18) in thermal forming it as shown in connection with the other figures. This makes for a stronger fitting, with rear segment less prone to failure due to high stresses during deflection for deployment or fatigue.

[0126] The pattern in Figure 19 provides for a fitting in which a graft can be sandwiched between outer band (156) and inner band (158). In this manner, the outer band acts like collar band (40) to hold graft (6) against host vessel (8). Tab (22) is provided to help grip graft (6) as shown and described in connection with Figure 1. [0127] The pattern in Figure 20 provides for a fitting with multiple undulations adapted to provided a measure of both axial and radial flexibility. Flexible fittings work particularly well with a collar. Especially in connection with a collar having locking members, it is useful to be able to compress the fitting when locking the collar around it so that upon expansion of the collar around the fitting to its locked limit, a graft is snugly captured between the fitting and the collar. [0128] However, another feature of fitting pattern (144) shown in Figure 20, makes a fitting so configured well suited for use without a collar. The absence of a tab at medial portion (160) provides a surface upon which to apply a bioadhesive to directly attach graft (6) to the fitting.

[0129] Figures 21a-25b show patterns (162) for creating collars (12). Collars may be made in a similar fashion to the fittings as described above. Collars geometry is advantageously set to correspond in angle to the fitting chosen to form a matched set.

[0130] Figures 21a and 21b show projections to produce collars substantially as described above. A notable distinction between the two is the inclusion of locking features (36) in the later image.

[0131] Figures 22a and 22b depict similar collars, except that additional tabs

(24) are included in each. Also the manner of providing lateral portions (44) differs. The are no longer discreet members as shown in Figures 21a and 21b. Instead, in the variation shown in Figure 22a, they are provided in connection with an proximal section (164) of the collar. In the variation in Figure 22b, they are provided in connection with a distal section (166) of the collar. An advantage of the approach in Figure 22a is that a stiffer forward section results providing greater force bearing upon graft (6) for improved hemostasis. An advantage of the approach in Figure 22b is that upward deflection of distal band (40) causes, lateral portions (44) flex outward to provide additional clearance for connector insertion.

[0132] Figure 23 shows a projection or pattern (162) configured to provide a collar (12) with overlapping ends (168). This avoids the production of a significant seam at the rear of a graft, thereby providing more support and improving graft patency. Another optional feature shown in connection with Figure 23 (see also figure 25b) is a distal band shape intended be a mirror or complement the front portion of a matching fitting. [0133] Figures 24a-24c show collar projections (162) including various retention features for grasping a graft (6) in addition to any tabs (24) provided. The variation in Figure 24a includes barbs or tangs (170). The variation in Figure 24b includes elongate tabs or fingers (172). The variation in Figures 24c includes undulations or gripping features (50) as described above. The variation in Figure 24c also includes a different type of locking mechanism (36) than observed elsewhere in the figures. A lead-in feature is provided so a simple squeezing application of force the sides of the collar locks it.

[0134] Figures 25a and 25b show examples of other features that may be included in collars according to the present invention. Fittings in accordance with each of these projections utilize distal section (166) to secure a graft about a fitting. The proximal section (164) in each serves to relieve strain on the graft. By avoiding the use of a pair or rib segments (46) along the length of the collar as shown in connection with the collar in Figure 42a and instead attaching proximal section features by bridge elements (174), greater flexibility is achieved for the portion of each fitting supporting the back of a graft. In the variation shown in Figure 25 a, the placement of the elements also results in different stiffness of band sections (176) and (178). In the variation in Figure 25b, change in stiffness form one band section to the next is evident in view of the decreasing size of the material forming the same and the offset loop (180) and curl (182) features provided. Alternately, successive loops or curls may be employed. Any of these features alone, or in combination may comprise a means for strain relief on a graft. Still further optional features for collars used in the present invention may include any of those described in the references cited above.

[0135] The function of the connector (as an in-flow anastomotic junction or out-flow anastomotic junction) also impacts the location of the graft toe (48) (e.g. inside the host vessel, and/or outside the host vessel). Other aspects of the anastomotic junction also impact the location of the graft toe. For example, when securing a graft to a host vessel having a large wall thickness (e.g. aorta), the graft toe (48) is preferably located along the interior surface of the host vessel so the thick cut end of the aorta is not exposed to blood flow. As such, flow disruptions are avoided by ensuring a smooth transition from the graft to the host vessel. [0136] When everting the tissue to minimize the metal exposed to blood, the graft toe is preferably located along the interior surface of the host vessel therefore the cut end of the graft and host vessel are isolated from blood flow. As shown in Figures 36d and 36e, the cut/beveled end of the graft toe readily everts around the toe of the fitting (10); the cut bevel easily wraps around the slightly curved cross-section of the leading segment (16) by taking opposite free edges of the cut tissue and pulling them around opposite sides of the leading segment and securing them in place by use of pins (55) and/or compressing them between two components as shown in Figures 36c and 36d. On the contrary, the side of a host vessel is extremely difficult to evert because all edges of the tissue are constrained so the only way to evert is to overstretch the tissue which results in unwanted damage.

[0137] Figures 34a and 34b show an alternative fitting embodiment (10) that along with collar embodiment shown in Figures 35a and 35b produce a connector capable of producing an in-flow anastomotic junction and/or an anastomosis having a host vessel to graft inner diameter ratio » 1. As shown in Figure 34a, the separation between lateral portions (20) is increased to accommodate the larger host vessel while the separation between the sides of the base (14) accommodate the smaller graft. As described above, a latch or tab (22) on the fitting mates with the corresponding latch or tab (24) on the collar (see Figures 34a and 35a). The trailing segment (18) in this embodiment is designed to penetrate through a small puncture in the heel portion of the graft just proximal to the end of the incision (described below). This secures the heel of the graft to this fitting embodiment because the stem region at the heel of the fitting is non-existent.

[0138] Pins (55) may be used to hold the toe region of the graft against the fitting during insertion through the arteriotomy ensuring the graft toe region resides against the interior surface of the host vessel. The collar incorporates a heel segment (57) to account for the elimination of the wedge with this embodiment. A slot in the heel region accommodates insertion of the trailing segment (18) to lock the collar to the fitting at the heel. As previously stated, tab (24) may be locked to tab (22). Side springs (33) enable extension of tab (24) beyond tab (22) during loading and return towards its resting configuration when the external, extension force is removed thereby locking tab (24) to tab (22). A distal band (39) matches the leading segment (16) and lateral portions (20) of the fitting to provide compression around the anastomosis. A grasping loop (31) enables deflecting the distal band (39) as will be described below. It should be noted that this embodiment may be modified to

accommodate host vessel to graft inner diameters < 1 by thermally forming the lateral

portions (20) of fitting and separation of distal band (39) of collar to accommodate host vessel inner diameters smaller than or equal to the graft inner diameter. [0139] Figures 36a and 36b provide an all-in-one connector embodiment that incorporates the fitting and collar functions into a unitary connector. This unitary connector (11) incorporates a leading segment (16) that defines lateral portions (20) which are integrated to a trailing segment (18). As described in Figures 34a and 34b above and shown in Figure 36e, the trailing segment (18) is placed through a puncture (63) in the heel of the graft just beyond the incision through the graft that produces the graft toe. This locks the graft to the connector at the heel region. Leading segment (16) produces a hinge (61) to base (14, 41) that enables deflecting the leading segment, lateral portions, and trailing segment while placing the graft toe between the lateral portions (20) and base (14, 41).

[0140] Once positioned, the external force deflecting the lateral portions is removed allowing the lateral portions to return towards their preformed shape compressing the graft toe (48) between the lateral portions (20) and the base (14, 41). A second hinge (59) integrates the distal band (39) and the heel segment (57) to the base (14, 41). The distal band (39) is deflected during deployment, as described below, to provide a separation that host vessel tissue may enter for compressing the graft and host vessel between components of the connector. The heel segment (57) compresses the host vessel against the trailing segment (18) to maintain position of the connector in the host vessel and stabilizes the graft at the heel of the anastomosis. Pins (55) may be used to evert the graft toe (48) to lock the graft in place. The pins (55) may be used when the compression force between the lateral portions (20) and the base (14, 41) about hinge (61) is not adequate to lock the graft to the connector or when the operator wants to isolate the cut end of the graft from blood flow. Figures 36d and 36e show the unitary connector (11) with a graft toe (48) clamped between the lateral portions (20) and the base (14, 41) and everted over pins (55). Figure 36c shows the compression forces used to lock the graft and host vessel to the unitary connector. Forces (FI, F2, Gl, and G2) may be optimized by altering the stiffness and/or spring constants of hinges (61 and 59) to ensure the graft and host vessel are captured by and locked to the unitary connector (11).

[0141] Now that many of the device features of the invention have been described, the process associated therewith is set forth in the order in which it is preferred that a surgeon or surgical team take action to perform a coronary bypass procedure, peripheral bypass procedure, or other procedure associated with creating anastomoses between tubular body structures during surgical, minimally invasive, endoscopic, robotic, catheter-based, or a combination of these approaches. Variation of this procedure is, of course, contemplated. Furthermore, it is to be understood that the devices described herein may be used outside of this context. [0142] This being said, after opening a patient and taking a measurement between intended target sites for in-flow (proximal) and out-flow (distal) anastomoses or by reference to the panel of measurement members (78) discussed above, a graft member (6) of sufficient length may be obtained. Typically this will be a saphenous vein. Alternately, another harvested vessel (such as the left internal mammary artery, right internal mammary artery, or radial artery, or other autologous vessel), a synthetic graft (e.g. ePTFE, urethane, etc.), non-vascular autologous tissue (e.g. pericardium, submucosa, etc.), a genetically engineered tubular structure, or a donor tissue may be used as a graft.

[0143] Especially in the case where an organic member is used, the vessel is preferably be sized to determine the appropriate connector size. This is preferably done with reference to the inner diameter of the graft by inserting pins of increasing size (e.g. by 0.25 increments) until the graft no longer easily fits over a given pin. The size of the largest pin over which graft easily fits over sets the inner diameter of the graft. Alternatively, a "go/no-go" gauge may be used where a single connector covers a wide range of graft inner diameters. The "go/no-go" gauge would have a minimum inner diameter and a maximum inner diameter at which the inner diameter of the graft should reside to be used with the specific connector configuration. [0144] Next, a connector for producing an anastomosis at a desired angle, and having an appropriate size is chosen. The size of fitting (10) and optional collar (12) covers a range of graft inner diameters and is preferably chosen by matching the first incremental size over the inner diameter of the graft to a chart of connector sizes that accommodate the measured graft diameter. It is contemplated that connector component sizes may be sized to fit grafts of a diameter from about 2 mm to about 6 mm progressively, at 0.5 mm to 2.0 mm increments. The acute angle of the connector embodiments enables a specific connector size to accommodate a wide range of graft sizes because the graft is oriented at an angle relative to the connector bore and this relationship may alter based on the size matching between the graft and the connector. For example, a 3 mm diameter connector has been demonstrated to accommodate graft inner diameters between 3 mm and 5 mm without constricting the lumen of the graft or otherwise adversely affecting the transition from the graft to the host vessel with respect to flow barriers or disruptions.

[0145] Once appropriately sized connector components are chosen, a graft may be skeletonized about 10 mm away from the end to be used in connection with the distal anastomosis. This may be accomplished by holding the adventitia tissue away from the graft with forceps and removing selected portions with Potts or dissecting scissors. At this stage, graft (6) may be cut in such a manner as discussed above and advanced over fitting (10) into a position as depicted in Figures 1, 2, 6, or 42a. [0146] At this stage, graft (6) may be passed through the collar (12). To accomplish this, a number of optional spreading mechanisms may be used to hold collar (12) open to advance it over graft (8). Figures 37, 39a, 39b and 40 depict optional spreader devices (92). While spreader (92) in Figure 37 has additional utility as described below, those depicted in Figures 39a and 39b and 40 are more specialized. The spreader in Figures 39a and 39b include an adjustable locking feature (94) as well as grooves (96) to capture the opposite sides or rib segments (46) of a collar. The spreader variation shown in Figure 40, is a modified clamp. Bracketed ends (98) affixed to an otherwise common implement provide the means to open collar (12) to place it on graft (6) loaded onto fitting (10). Such an instrument may be more familiar to a surgeon, and therefore preferred.

[0147] In placing fitting (10) into graft (6), it is to be set in relation to collar

(12) in a complementary manner. When optional tabs (22) and (24) are provided, these features can easily be used to help align a fitting and a collar relative to each other. Either way, once collar (12) and fitting (10) are properly aligned, tabs and/or locking features (36) may be engaged with each other, collar (12) is released onto graft (6), and a final check is made to ensure accurate component placement and graft coverage.

[0148] In the event a proximal connector is to be used to complete a coronary bypass procedure, it may be connected to graft (6) in a similar fashion or as described variously in the references cited above. Still, as noted above, a distal connector may alone be used, with the proximal anastomosis to be accomplished otherwise. While it need not be the case, the distal connector will preferably be deployed before making the proximal connection.

[0149] Alternative mechanisms may additionally be used to pass graft (6) through collar (12).. The collar (12) may be housed on a loading cartridge (see Figures 46b, 48a to 48d) which, when attached to the loading tool base (see Figures 46c and 49), may be expanded by spreading the ears of the collar (12) apart thereby expanding the collar (12) at the expansion spring and providing an enlarged lumen through which to pass the graft. The loading cartridge (202) may contain a flex region, an interlock, and pins (204). The pins (204) are used to stabilize the collar (12) during shipment and expansion on the loading tool. A mating insert (206) may be used to stabilize the collar (12) relative to the outer frame cartridge (202) during shipping; this insert (206) is removed and disposed prior to placing the outer frame cartridge. The interlock enables temporarily securing the loading cartridge to the loading tool (212) during placement of the graft and latching of the fitting. The flex region provides an integrated hinge through which the loading cartridge thus the collar may be expanded. A lever (218) may be used to manually expand the collar, as shown in Figure 46c; alternatively, as shown in Figure 49, the collar automatically expands as the outer frame cartridge is locked to the loading base. [0150] The loading tool embodiment shown in Figure 49 also includes features to stabilize the deployment tool while placing the connector assembly into the deployment tool and deflecting the distal band (39) of the collar (12) and the trailing segment (18) of the fitting (10).

[0151] Advancing graft (6) through collar (12) may be accomplished with an elongate, low profile clamp or forceps to pull graft through the expanded collar. Once the graft is positioned, an incision from the free end of the graft is created to define the graft toe (48). The length of this incision depends on the diameter of the connector and the angle of the anastomosis. For a 30 degree, 3 mm connector, a 9 to 10 mm incision is created to define the graft toe (48). The graft toe (48) must completely cover the leading segment (16) of the fitting (10) and extend around the lateral portions (20). This graft toe (48) provides the interface at which the cut edges of the host vessel are clamped thereby ensuring hemostasis.

[0152] Then, the fitting (10) is inserted through the cut end of the graft until the trailing segment (18) of the fitting abuts the expansion spring (35) of the collar. This ensures that the graft is completely captured between the fitting and the collar, which is essential to ensuring hemostasis at the anastomosis. Once in place about fitting (18), graft (6) may be trimmed to more closely conform to the shape of connector elements, particularly the distal band (39) of the collar (12). [0153] The loading tool primarily facilitates these steps by utilizing the design of the collar and fitting to minimize the amount of manipulation required to engage the tabs and lock the collar to the fitting about the graft. Once the outer frame cartridge (202) is placed onto the loading tool (212), e.g., at pins (214), it is expanded so the graft may be inserted through the bore of the collar. After cutting the incision in the graft the inner frame cartridge (200) is used to advance the fitting into the cut end of the graft such that the trailing segment (18) of the fitting is oriented into engagement with the expansion spring (35) of the collar. As shown in Figures 46a and 47a to 47c, different variations of the inner frame cartridge (200) incorporates a snap (210) and a handle (208) to direct the insertion path of the fitting (10), which is placed on the end of a positioning shaft (226), such that the base (14) of the fitting passes into the cut end of the graft and under the expansion spring (35) of the collar while the trailing segment (18) of the fitting resides outside the graft and expansion spring.

[0154] Once the trailing segment (18) is appropriately positioned, the inner frame cartridge is snapped into engagement with the loading tool at dock (216). Then the inner frame cartridge is advanced using a shaft dial (220 or 318) thereby advancing the fitting relative to the collar. An indicator gauge (222) may be placed upon the loading tool (212) to indicate the distance advanced by the fitting. The expansion spring stretches at the side undulations causing the distance between, the tabs of the collar and fitting to shorten. Once the inner frame cartridge is fully advanced, the tab of the collar extends beyond the tab of the fitting. It has been demonstrated that 0.070 in to 0.150 in extension of the collar at the expansion spring using the fitting places the tab (24) of the collar beyond the tab (22) of the fitting. The loading tool is rotated 180 degrees and a pusher (224) (see Figure 46d) is used to apply downward pressure against the tab or latch of the fitting while the shaft dials of the loading tool are used to retract the inner frame cartridge allowing the expansion spring to return towards its resting undulating shape and engaging the tabs about the graft. At this point the connector and graft assembly is complete and ready for deployment.

[0155] Once the fitting and graft is assembled, deployment may be achieved through one of several alternative methods and tools. Figure 41a shows a deployment device (52) similarly adapted to draw back band (40) while advancing rear segment (18) in a manner similar to the deployment device shown in Figure 42a. Interface section (58) captures band (40) while hook (100) advances rear segment (18). To accommodate differences in anatomical access locations or paths, it is also possible to orient the end of the deployment device shown in Figure 41a at another angular orientation as shown in Figure 41b. In this case, the instrument head is shown rotated approximately 90°. It is also noted that the deployment device in Figure 41a optionally includes interlocking members (102) and sprung arms (104), that work in conjunction with each other to provide a more user-friendly device able to provide a more stable, user-friendly device to maintain a connector in a state ready for deployment.

[0156] Alternate deployment mechanisms are portrayed in Figures 43 a, 43b,

44, and 45. The deployment device in Figures 43a and 43b includes a primary handle (106) and an actuator handle (108). When actuator handle (108) is advanced, band grasping interface member (110) with interface section (58) is advanced as shown in Figure 43b. Pin (112) within opening (114) limits the extent to which it may be advanced or withdrawn. When band interface member (110) is retracted as shown in Figure 43 a, to draw band (40) back from lead segment (16), the rear segment of a fitting abuts interface section (60) to ready the connector for deployment. [0157] Figure 44 shows another type of deployment device (52). In this variation, a handle portion (116) and an actuator portion (118) to be slidably received by handle portion (116) is used by hooking rear segment (18) in retractor opening (120) and drawing it into recess (122) when connector (4) is set in receptacle section (124).

[0158] Figure 45 shows an end section (126) of yet another type of deployment device. This variation is adapted for sideways deployment of a connector. In combination with each other, top and bottom portions (128) and (130) restrain a com ector, compressing rear section (18) ready for connector deployment. A deployment mechanism incorporating side-deployment end section (126) may be advantageously used in situations where access to the host vessel is hindered by little clearance due to a small thoracic cavity or difficult vessel orientation. The graft of a graft/connector combination is received in guide section (132), and stop (134) limits how deeply the combination may be set into the deployment device end section (126). [0159] It is preferred that connector (4) be set and prepared for deployment within a deployment device, e.g., as shown in Figures 42a, 42b, 50a and 50b, before taking invasive action at the target site for an angled anastomosis. Regardless, an angled anastomosis site is prepared by creating an initial puncture, for instance, with the tip of a number 11 blade scalpel. Next, this opening is preferably extended longitudinally with scissors to about 3 mm to 7 mm in length depending on the connector size and anastomosis angle. Most often, a longitudinal slit of about 5 mm is preferred for a 30 degree, 3 mm connector. Scissors are advantageously provided in connection with an instrument. Otherwise, standard Potts scissors may be used. In one arteriotomy (or venotomy) instrument embodiment, a marker pen is used to place biocompatible ink on a marking instrument with a specified length and the marking instrument is used to tattoo an identifier as to the desired incision length. This helps direct the operator to cut the incision to the appropriate length without requiring the use of a specific blade instrument designed to only create the desired incision with a single actuation.

[0160] It may be preferred to use a stabilizing member (134) to help accomplish the arteriotomy. Figure 38 shows a suitable device. It includes a handle (136) and an endpiece (138). A bridge (140) provides clearance for a coronary artery, while feet (142) are set against the heart of a patient. Gradations or other indicators in endpiece (138) help provide a visual indication for creating appropriately long arteriotomy. Once an arteriotomy of sufficient length has been created, it is preferably held open by arms (142) of a spreader (92) as shown in figure 7. [0161] The deployment tool in Figures 50a-50d, 51a, and 51b incorporated pins (270) that may engage the ears (37) of the collar. This provides stabilization of the connector relative to the deployment tool and provides a reference from which to deflect the distal band (39) of the collar. It should be noted that the deployment tool may alternatively incorporate a clamping or other grasping mechanism to engage the base of the collar and/or fitting without having to penetrate components of either the collar or fitting. One such component is a stabilization platform (266) incorporated in the deployment tool and configured to engage the front and/or lateral surface of the connector to maintain the position of the connector during deployment. A combination of stabilization platform (266) and pins (270) are used in the embodiments shown in Figures 50a to 5 Od, 51a and 51b.

[0162] The deployment tool may also incorporates a toe deflector (264) and a heel deflector (262), which engage the elliptical loop (31) to deflect and release the distal band (39) of the collar and the trailing section (18) of the fitting during deployment. Figure 51a shows the toe deflector (264) and the heel deflector (262) in the loading or release state. Figure 51b shows the toe deflector (264) and the heel deflector (262) in the actuated state, ready for deployment of the connector. It should be noted that in Figure 51b, the components of the connector are not shown deflected; in operation, movement of the toe deflector and heel deflector may cause their counterparts on the connector to correspondingly deflect for deployment. [0163] Once deployed, the heel deflector (262) and toe deflector (264) are released enabling the trailing section (18) of the fitting and the distal band (39) of the collar to return towards their resting configuration causing the tissue (host vessel and graft) residing between the fitting and the collar to be compressed, like a gasket, and ensure hemostasis at the anastomosis. It should be noted that the toe deflector (264) and the heel deflector (262) may be actuated simultaneously; the toe deflector may be offset from heel deflection to enable full deployment of the trailing section of the fitting prior to full release of the distal band of the collar; or may be operated independently.

[0164] With the trailing segment and the distal band deflected into the deployment configuration, connector (4) is positioned into the host vessel. This is preferably performed by inserting the leading section (16) through the arteriotomoy (or venotomy if the host vessel is a vein), and then advancing the lateral features (20) of fitting (10) as maybe provided. Deflected trailing segment (18) is then advanced through the heel end of the arteriotomy and into host vessel (8); then the trailing segment (18) is released by actuating the deployment tool towards its resting configuration, as shown in Figure 6, in order to secure the connector. Particularly in those variations of the invention as described above where movement of trailing segment articulates side portions (20), movement of trailing segment (18) to an host- vessel engaging position will also cause affected side portions (20) to engage the sides of host vessel (8) to maintain connector (4) in place. [0165] In instances when a collar (12) is used in connector (4), it may also be released to compress front portion (48) of graft (6) against host vessel (8). Release of collar (12) may also result in compressing graft (6) against portions of host vessel (8) opposed by lateral fitting portions (20), especially when the lateral portions are integrated with the trailing segment.

[0166] The deployment tool embodiment shown in Figures 50a to 50d enables offsetting the movement of the toe deflector (264) relative to the heel deflector (262) with a single actuation mechanism. This offset facilitates full release of the trailing segment (18) prior to release of the distal band (39) of the collar with a single handle actuation to provide operator control of the connector release. As such the trailing segment (18) may be fully released so the operator can confirm its position within the host vessel, ensure the sides of the incision through the host vessel are appropriately positioned around the lateral portions (20) of the fitting, and/or de-air the graft prior to releasing the collar distal band (39).

[0167] The embodiment in Figures 50a to 50d includes two handle segments

(246) rotatably connected to a handle block (242) at a proximal end directly with pins (256). The handle segment (246) is secured to linkages (248) that pass through slots in the handle block (242) at a mid-section and are secured to a rod (252) that contains a luer end (244) and a flush path (240). The flush path, as shown in Figures 50c and 50d provides a conduit for flushing cleaning solution, saline, or other fluid when cleaning the deployment tool, and/or injecting saline or CO2 mist to clear the field of view from blood. The rod (252) moves within a shell (250) that is bonded to the handle block (242). The length and orientation of rod and shell are determined by the procedure specifics. For less invasive access, the rod and shell are relatively long (> 15 cm) to ensure the connector may reach the host vessel without the handle segments (246) interfering with the access points into the patient. The rod and shell may be curved to enable changing the angular pathway for inserting the comiector into the host vessel. Alternatively, the rod and/or shell may be made malleable to enable the operator to tailor the deployment tool to his/her access viewpoint. [0168] A compression spring (254) provides resistance to advancing the rod

(252) relative to shell (250) and handle block (242) and ensures the resting position of the deployment tool is in the deflected state. The compression spring (254) is stiff enough such that with the trailing segment (18) of the fitting and the distal band (39) of the collar deflected, the deployment tool may be handed to the operator without having to manually hold the handle apart or worrying that the handle may accidentally become actuated and release the connector before it is appropriately positioned. Alternatively, a locking mechanism may be incorporated in the deployment tool to ensure the handle does not accidentally actuate.

[0169] The stabilizer (266) is bonded to the shell (250) and provides a support for the connector and defines the pivots for the toe deflector (264) and the heel deflector (262). The stabilizer also determines the angle at which the connector sits relative to the rod and shell of the deployment tool. For reverse insertion the stabilizer (266) is configured to orient the toe of the connector at an acute angle (< 90 degrees) to the shell of the deployment tool. For perpendicular insertion, the stabilizer is configured to orient the toe of the connector at approximately 90 degrees to the shell. For acute insertion, the stabilizer is configured to orient the heel of the connector at an acute angle (< 90 degrees) to the shell.

[0170] The toe deflector (264) and the heel deflector (262) are rotatably attached to the stabilizer (266) with pins (256). Intermediate linkages (258 and 260) connect the proximal ends of the heel deflector (262) and the toe deflector (264) to the rod (252) with a second compression spring (254) to orient the deflectors in the appropriate resting, "deflected" orientation when released. The intermediate linkages (258 and 260) and the associated compression spring (254) enable the offset deflection of the toe deflector (264) from the heel deflector (262). As the heel deflector is actuated by squeezing the handles (246) the toe deflector (264) remains in the deflected, non-released position until the trailing segment (18) is fully released and the compression spring (254) is fully actuated such that movement of the rod engages the toe deflector linkage (260) which initiates the actuation of the toe deflector (264) and releases the distal band (39) of the collar. This two-staged release provides one additional benefit in that a tactile signal indicates the complete release of the trailing segment (18) and initiation of the release of the distal collar band (39). The toe deflector (264) provides another benefit in that it separates the ears (37) of the connector from engagement with the pins (270) once fully actuated to fully release the connector from the deployment tool and indicating completion of the angled anastomosis.

[0171] Once in place, the completed anastomosis may be inspected for leakage. This may be done before and/or after an anastomosis at the other end of the graft (if required) is complete. At a minimum, an inspection of the anastomosis is preferably made when blood is flowing through graft (6). If leakage is detected, and it cannot be remedied by adjustment of the graft or collar, the anastomosis site may be packed until bleeding terminates. Bioglue (e.g., as available through Cryolife in Kemiesaw, GA) may be applied to the anastomosis and/or a stitch of suture material may be applied.

[0172] In extremely rare instances where these steps do not prove adequate, it may be necessary to reposition or remove the connector (4). Figures 52a and 52b show a repositioning tool designed to spread the sides of the collar distal band (39) and manipulate the connector such that tissue enters the gap between the lateral portions (20) of the fitting and the distal bad (39) of the collar. Once repositioned, the repositioning tool releases the collar. The repositioning tool has two handles (276) rotatably joined at a pivot pin (278) and with a spring (274). The functional end of the repositioning tool contains extensions (280) designed to fit within the edges of the distal band (39) and spread the distal band once actuated. A stabilization bar (282) is integrated with the extensions (280) and provides a surface to advance the connector once the distal band is spread open. Figures 53a and 53b show an extraction/repositioning tool whose active end contains a toe grasping rod (284) and a heel pusher (286) having similar engagement features as the toe deflector and heel deflector discussed above. The toe grasping rod deflects the distal band (39) of the collar while the heel pusher deflects the trailing segment of the fitting. This tool may be used to partially deflect the distal band and trailing segment to reposition the connector or fully deflect those components to remove the connector from the host vessel. Figures 54a and 54b show a removal tool that differs from the embodiment in Figures 53a and 53b in that the heel pusher (286) is curved to fully advance the trailing segment (18) of the fitting as the curved end is advanced into the wedge between the base (14) of the fitting and the trailing segment (18). [0173] For less invasive approaches, bridging or endoscopic vein harvesting tools may be utilized to access the host vessel, expose the host vessel and stabilize the host vessel as the arteriotomy is created and the connector is deployed into the host vessel. Such devices include the SaphLITE® manufactured by Genzyme Surgical,

Inc. for saphenous vein harvesting. This, and other such bridging devices, may be used to access peripheral host vessels through a small incision, and enable a less invasive approach to inserting angled connectors into the popliteal artery, femoral artery, iliac artery, etc. due to the features of the connector and accessory devices. The connector may also be used in conjunction with anastomosis isolation devices

such as the eNclose® Anastomosis Assist Device manufactured by Novare Surgical, Inc. Such isolation devices clamp a region of the aorta and provide a membrane to prevent bleeding while the anastomosis is created. As such, the angled connector embodiments in this invention may readily be inserted through an incision created prior to or after deploying such isolation device and used to create the anastomosis. [0174] Now, returning to the elements of connector (4), optional inventive features and a manner of manufacture is described. A preferred manner of producing connector components according to the present invention is by machining tubing to include features that may be stressed and set into shape to produce connector elements like those depicted above. Shapes so produced may be referred to as wireforms. [0175] The machining may be accomplished by electron discharge machining

(EDM), mechanically cutting, laser cutting or drilling, water-jet cutting or chemically etching. It is to be noted that portions of the connectors may be fabricated as a separate components and bonded by spot welding, laser welding or other suitable manufacturing process to form complete structures. Typically, after whatever cutting or forming procedure is employed, the material may be set in a desired final shape. Where a metal is used, one or more flexure steps followed by heating will accomplish this. If the connector elements are made of alternate material such as a plastic or a composite, other forming procedures as would be apparent to one with skill in the art may be used.

[0176] Preferably, connector elements are made from a metal (e.g., titanium) or metal alloy (e.g., stainless steel or nickel titanium). Other materials such as thermoplastic (e.g., PTFE), thermoset plastic (e.g., polyethylene terephthalate, or polyester), silicone or combination of the aforementioned materials into a composite structure may alternatively be used. Also, connectors fabricated from nickel titanium may be clad with expanded PTFE, polyester, PET, or other material that "may have a woven or porous surface. The fittings may be coated with materials such as paralyne or other hydrophilic substrates that are biologically inert and reduce the surface friction.

[0177] To further reduce the surface tension, metallic or metallic alloy fittings may be bead blasted, chemically etched, and or electropolished. Evidence suggests that electropolishing reduces platelet adhesion because of the smooth surface. Alternatively, the fittings maybe coated with heparin, thromboresistance substances (e.g., glycoprotein Ilb/iIIa inhibitors), antiproliferative substances (e.g., rapamycin), or other coatings designed to prevent thrombosis, hyperplasia, or platelet congregation around the attachment point between the bypass graft and the host vessel. Alternatively, a material such as platinum, gold, tantalum, tin, tin-indium, zirconium, zirconium alloy, zirconium oxide, zirconium nitrate, phosphatidyl-choline, or other material, may be deposited onto the fitting surface using electroplating, sputtering vacuum evaporation, ion assisted beam deposition, vapor deposition, silver doping, boronation techniques, a salt bath, or other coating process.

[0178] A still further improvement of the fittings is to include beta or gamma radiation sources on the end-side fittings. A beta or gamma source isotope having an average half-life of approximately 15 days such as Phosphorous 32 or Paladium 103 may be placed on the base and/or petals of the end-side fitting using an ion- implantation process, chemical adhesion process, or other suitable method. Further details as to optional treatments of connectors according to the present invention are described in 10.00. Of course, connector fitting (10) and any associated collar (12) may be made differently. To avoid electrolytic corrosion, however, dissimilar metals should not be used.

[0179] Preferably, NiTi (Nitinol) tubing or flat stock may be used to produce connector components. Irrespective of material format, a preferred alloy includes a 54.5-57% Ni content, and a remainder Ti by weight (less minor amounts of C, O, Al, Co, Cu, Fe, Mn, No, Nb, Si and W) is used. Such alloy has an Af for at about -10 to - 15°C. Consequently, for typical handling and in use, the material will exhibit superelastic properties as is most desired.

[0180] Still, it is contemplated that connectors according to the present invention may utilize thermoelastic or shape memory characteristics instead, wherein the material of either or both fitting (10) and connector (12) change from a martensitic state to an austenitic state upon introduction to an anastomosis site and exposure to a sufficiently warm environment. Taking advantage of the martensitic state of such an alloy will ease deflecting rear segment (18) and distal band (39) and maintaining their positions until placement.

[0181] Utilizing either thermoelastic or superelastic properties makes for a connector that can have certain members stressed to a high degree and return without permanent deformation from a desired position. However, it is contemplated that either or both fitting (10) and collar (12) may be made of more typical materials such as stainless steel or plastic. For fitting (10), this is feasible in view of the manner in which rear segment (18) is displaced for insertion into a host vessel. Hinge section (28) may permit designs in which the stress applied by torsion is lower that applied in simply deflecting a rear petal or segment as shown and described in U.S. and foreign patents and applications entitled, "Improved Anastomosis Systems", U.S. Patent Application Serial No. 09/730,366; "End-Side Anastomosis Systems", PCT Publication No. WO 01/41653; "Advanced Anastomosis Systems (II)" U.S. Patent Application Serial No. 09/770,560.

[0182] The invention has been described and specific examples or variations of the invention have been portrayed. The use of those specific examples is not intended to limit the invention in any way. In all, it is to be understood that each of the features described in connection with the various connector components and projections for forming the same may be mixed and matched to form any number of desirable combinations. Further, it is contemplated that additional details as to the use or other aspects of the system described herein may be drawn from Abstract, Field of the Invention, Background of the Invention, Summary of the Invention, Brief Description of the Drawings, the Drawings themselves and Detailed Description and other background that is intended to form part of the present invention, including any of the patent applications cited above, each of which being incorporated by reference herein in its entirety for any purpose. Also, to the extent that there are variations of the invention which are within the spirit of the disclosure and are equivalent to features found in the claims, it is the intent that the claims cover those variations as well.

[0183] All equivalents are considered to be within the scope of the claimed invention, even those which may not have been set forth herein merely for the sake of relative brevity. Finally, it is contemplated that any single feature or any combination of optional features of the inventive variations described herein may be specifically excluded from the invention claimed and be so-described as a negative limitation.

Claims

CLAIMS What is claimed is:
1. An anastomosis connector system comprising a fitting comprising: a base adapted for attachment to a graft, a leading segment adapted for introduction into a host vessel, and a rear portion including a rear segment and a hinge zone, said rear segment comprising an elongate form with a proximal end, a distal end, first and second lateral portions, said hinge zone comprising at least one segment connecting each lateral portion of said rear segment to said base, wherein said rear portion is deflectable about said hinge zone such that said fitting can be advanced into a host vessel, and upon return to a substantially undeflected position said rear segment in conjunction with at least said leading segment prohibits retraction of said fitting for the host vessel, and wherein said base sets an angle between about 20° and about 70° between a distal end of said graft and a portion of said host vessel adjacent said fitting upon forming an anastomosis.
2. The system of claim 1, wherein said fitting further comprises lateral extensions between said leading segment and said rear segment.
3. The system of claim 2, wherein said lateral extensions are formed by portions separated from said body that are contiguous with said leading segment.
4. The system of claim 2, wherein said fitting is adapted to draw said lateral extensions inward upon deflecting said rear portion about said hinge zone.
5. The system of claim 1, wherein said base is adapted to be compressed to a reduced size.
6. The system of claim 1, wherein said rear portion is adapted for deflecting said rear segment toward said leading segment.
7. The system of claim 1, wherein said rear portion is adapted for deflecting said rear segment away from said leading segment.
8. The system of claim 1, wherein said fitting comprises a wireform.
9. The system of claim 8, wherein said wireform is produced by removing material from stock selected from a group consisting of tube stock and flat stock.
10. The system of claim 1, wherein said fitting further comprises at least one tab adapted to secure a graft to said fitting.
11. The system of claim 1, wherein said fitting further comprises at least one tab adapted to secure a collar around a graft positioned between said fitting and said collar.
12. The system of claim 1, further comprising a proximal section and a distal section, said collar being adapted for attachment to said fitting.
13. The system of claim 12, wherein said collar comprises a split member.
14. The system of claim 13, wherein said collar further comprises a latching mechanism to lock said split member in a closed position.
15. The system of claim 12, wherein said collar comprises a wireform.
16. The system of claim 15, wherein said wireform is produced by removing material from stock selected from a group consisting of tube stock and flat stock.
17. The system of claim 13, wherein said distal section is adapted to relieve stress on a graft.
18. The system of claim 17, wherein said adaptation to relieve stress on a graft comprises a means for graft stress relief.
19. The system of claim 13, wherein said collar further comprises at least two lateral extensions at said distal section, said extensions adapted to improve hemostasis of said fitting when in use.
20. The system of claim 10, wherein said distal section is adapted to grasp a graft.
21. The system of claim 20, wherein said adaptation to grasp a graft comprises a means for grasping a graft.
22. The system of claim 1, wherein said fitting comprises a biocompatable material selected from the group consisting of stainless steel, titanium and titanium alloy.
23. The system of claim 22, wherein said titanium alloy comprises NiTi.
24. The system of claim 12, wherein said collar comprises a biocompatable material selected from the group consisting of stainless steel, titanium and titanium alloys.
25. The system of claim 24, wherein said titanium alloy comprises NiTi.
26. The system of claim 1, wherein a superelastic effect returns said rear segment to its substantially undeflected position.
27. The system of claim 1, wherein a thermoelastic or shape-memory effect returns said rear segment to its substantially undeflected position.
28. The system of claim 1, further comprising an instrument adapted to hold said fitting for deployment by deflecting said rear segment.
29. The system of claim 28, wherein said instrument is further adapted to draw at least a portion of said collar distal section away from said fitting leading segment.
30. A kit for preparing a graft fitting combination comprising: a panel of tubular members modeling the compliance of a graft and varying in length from about 60mm to about 150mm.
31. The kit of claim 30, wherein at least one end of each tubular member is attached to a member modeling the geometry of an anastomosis fitting.
32. The kit of claim 31, wherein said member models a fitting according to claim 1.
33. A method of creating an anastomosis comprising: advancing a leading portion of a fitting into an opening in a host vessel wall, advancing a rear portion of a fitting in a deflected position into said opening, said deflected position occurring by torsional displacement of said rear portion about at least two sections of said fitting, and forming a connection between said host vessel and a graft upon return of said distal portion from its deflected position to a position contacting a wall of said host vessel.
34. An anastomosis connector system, comprising: a fitting comprising a base adapted for attachment to a graft, a leading segment adapted for introduction into a host vessel, and a trailing segment comprising at least one lateral portion having a proximal end and a distal end, wherein the proximal end of the lateral portion is integrally attached along a torsional region which extends between the base and the leading segment, wherein the trailing segment is deflectable about the torsional region from a first position to a second position such that at least the leading segment and the trailing segment can be advanced into the host vessel and wherein the trailing segment is adapted to return to the first position such that retraction from the host vessel is inhibited.
35. The system of claim 34 wherein the torsional region comprises at least a proximal torsional member and a distal torsional member, wherein the proximal torsional member extends between the lateral portion and the base and the distal torsional member extends between the lateral portion and the leading segment.
36. The system of claim 34 wherein the trailing segment is integrally formed with the base and the leading segment such that they form a continuous support member for placement along an interior surface of the host vessel
37. The system of claim 34 wherein the fitting defines an angle between about 20° and about 70° between a distal end of the graft and a portion of the host vessel adjacent the graft.
38. The system of claim 37 wherein the fitting defines an angle of about 30° between a distal end of the graft and a portion of the host vessel adjacent the graft.
39. The system of claim 34 wherein the fitting further comprises lateral extensions between the leading segment and the trailing segment.
40. The system of claim 39 wherein the lateral extensions are formed by portions that are contiguous with the leading segment.
41. The system of claim 39 wherein the lateral extensions are adapted to be drawn inward upon deflecting the trailing segment about the torsional region.
42. The system of claim 34 wherein the fitting is adapted to be compressed to a reduced configuration.
43. The system of claim 34 wherein the trailing segment is deflected in the second position towards the leading segment.
44. The system of claim 34 wherein the trailing segment is deflected in the second position away from the leading segment.
45. The system of claim 34 wherein the fitting further comprises at least one tab adapted to secure the graft to the base.
46. The system of claim 34 further comprising a collar which is adapted to secure the graft to the host vessel between the fitting and the collar.
47. The system of claim 46 wherein the collar further comprises a collar tab adapted to interface with a complementary tab located on the fitting for securing the graft between the fitting and the collar.
48. The system of claim 47 wherein the collar further comprises at least one side spring member which extends from a heel portion of the collar to the collar tab.
49. The system of claim 48 wherein the side spring member is formed into a looped configuration.
50. The system of claim 46 wherein the collar further comprises at least one expansion spring member which is biased to compress the collar about the fitting.
51. The system of claim 50 wherein the expansion spring member has an undulating pattern when the collar is compressed about the fitting, and wherein the expansion spring member fonns a straightened shape when the collar is in an expanded configuration.
52. The system of claim 46 wherein the collar further comprises a distal band member which extends around the graft from a heel portion and is adapted to urge the graft against the collar.
53. The system of claim 52 wherein the distal band member has a semicircular shape'.
54. The system of claim 52 further comprising a looped member disposed along the distal band member at a toe portion which is in apposition to the heel portion.
55. The system of claim 46 wherein the collar comprises a split member.
56. The system of claim 34 wherein the fitting comprises a biocompatable material selected from the group consisting of stainless steel, titanium, and titanium alloy.
57. The system of claim 56, wherein the titanium alloy comprises NiTi.
58. The system of claim 46 wherein the collar comprises a biocompatable material selected from the group consisting of stainless steel, titanium and titanium alloys.
59. The system of claim 58 wherein the titanium alloy comprises NiTi.
60. The system of claim 34 wherein a superelastic effect returns the trailing segment from the second position to the first position.
61. The system of claim 34 wherein a thermoelastic or shape-memory effect returns the trailing segment from the second position to the first position.
62. The system of claim 34 further comprising an instrument adapted to hold the fitting for deployment by deflecting the trailing segment.
63. The system of claim 34 wherein the fitting further comprises a coating selected from the group consisting of biologically inert and biologically reactive materials.
64. The system of claim 34 wherein the fitting comprises a wireform.
65. The system of claim 64 wherein the wireform is produced by a method selected from the group consisting of electron discharge machining, mechanical cutting, laser cutting, laser drilling, water-jet cutting, and chemically etching.
66. The system of claim 64 wherein the wireform is comprised of a singular integral structure.
67. The system of claim 64 wherein the wireform is produced from tubing stock or flat stock from which material is removed.
68. The system of claim 67 wherein the tubing stock or flat stock has a wall thickness between about 0.004 in and about 0.010 in.
69. The system of claim 46 wherein the collar further comprises a coating selected from the group consisting of biologically inert and biologically reactive materials.
70. The system of claim 46 wherein the collar comprises a wireform.
71. The system of claim 70 wherein the wireform is produced by a method selected from the group consisting of electron discharge machining, mechanical cutting, laser cutting, laser drilling, water-jet cutting, and chemically etching.
72. The system of claim 70 wherein the wireform is comprised of a singular integral structure.
73. The system of claim 70 wherein the wirefomi is produced from tubing stock or flat stock from which material is removed.
74. The system of claim 73 wherein the tubing stock or flat stock has a wall thickness between about 0.004 in and about 0.008 in.
75. An anastomosis connector system, comprising: a fitting comprising a base adapted for attachment to a graft, a leading segment adapted for introduction into a host vessel, and a trailing segment comprising at least one lateral portion having a proximal end and a distal end, wherein the .proximal end of the lateral portion is integrally attached along a torsional region which extends between the base and the leading segment; and a collar which is adapted to secure the graft to the host vessel between the . fitting and the collar; wherein the trailing segment is deflectable about the torsional region from a first position to a second position such that at least the leading segment and the trailing segment can be advanced into the host vessel and wherein the trailing segment is adapted to return to the first position such that retraction from the host vessel is inhibited, wherein the torsional region comprises at least a proximal torsional member, which extends between the lateral portion and the base, and a distal torsional member, which extends between the lateral portion and the leading segment.
76. The system of claim 75 wherein the collar comprises a collar tab adapted to interface with a complementary tab located on the fitting for securing the graft between the fitting and the collar.
77. The system of claim 75 wherein the collar further comprises at least one expansion spring member which is biased to compress the collar about the fitting.
78. The system of claim 75 wherein the collar further comprises a distal band member which extends around the graft from a heel portion and is adapted to urge the graft against the collar.
79. An anastomosis connector system, comprising: a fitting comprising a base adapted for attachment to a graft, a leading segment adapted for introduction into a host vessel, and a trailing segment having a proximal end and a distal end, wherein the proximal end of the trailing segment is integrally attached along a torsional region which extends between the base and the leading segment, wherein the distal end of the trailing segment is adapted to extend through a first area of the graft such that the graft is at least partially secured to the fitting, the trailing segment being deflectable about the torsional region from a first position to a second position such that at least the leading segment and the trailing segment can be advanced into the host vessel.
80. The system of claim 79 wherein the trailing segment is adapted to return to the first position after being advanced into the host vessel such that retraction from the host vessel is inhibited.
81. The system of claim 79 wherein the distal end of the trailing segment extends through a puncture defined in the graft.
82. The system of claim 79 wherein the fitting further comprises at least one fastener for securing a second area of the graft to the fitting.
83. The system of claim 82 wherein the fastener comprises at least one pin adapted to hold the graft to the fitting during introduction into the host vessel.
84. The system of claim 79 further comprising a collar which is adapted to secure the graft to the host vessel between the fitting and the collar.
85. The system of claim 84 wherein the collar comprises an elongate heel segment which defines an opening adapted to receive the trailing segment for securing the collar to the fitting.
86. The system of claim 84 wherein the collar further comprises a collar tab adapted to interface with a complementary tab located on the fitting for securing the graft between the fitting and the collar.
87. The system of claim 86 wherein the collar further comprises at least one side spring member which extends from a heel portion of the collar to the collar tab.
88. The system of claim 86 wherein the side spring member is formed into a looped configuration.
89. The system of claim 84 wherein the collar further comprises at least one expansion spring member which is biased to compress the collar about the fitting.
90. The system of claim 89 wherein the expansion spring member has an undulating pattern comprising a middle undulation and at least two adjacent side undulations, wherein the middle undulation has a length which is shorter than a length of the side undulations.
91. The system of claim 84 wherein the collar further comprises a distal band member which extends around the graft from a heel portion and is adapted to urge the graft against the collar.
92. The system of claim 79 wherein the fitting comprises a biocompatable material selected from the group consisting of stainless steel, titanium, and titanium alloy.
93. The system of claim 92, wherein the titanium alloy comprises NiTi.
94. The system of claim 84 wherein the collar comprises a biocompatable material selected from the group consisting of stainless steel, titanium and titanium alloys.
95. The system of claim 94 wherein the titanium alloy comprises NiTi.
96. The system of claim 79 wherein a superelastic effect returns the trailing segment from the second position to the first position.
97. The system of claim 79 wherein a thermoelastic or shape-memory effect returns the trailing segment from the second position to the first position.
98. The system of claim 79 further comprising an instrument adapted to hold the fitting for deployment by deflecting the trailing segment.
99. The system of claim 79 wherein the fitting further comprises a coating selected from the group consisting of biologically inert and biologically reactive materials.
100. The system of claim 79 wherein the fitting comprises a wireform.
101. The system of claim 100 wherein the wireform is produced by a method selected from the group consisting of electron discharge machining, mechanical cutting, laser cutting, laser drilling, water-jet cutting, and chemically etching.
102. The system of claim 100 wherein the wireform is comprised of a singular integral structure.
103. The system of claim 100 wherein the wireform is produced from tubing stock or flat stock from which material is removed.
104. The system of claim 103 wherein the tubing stock or flat stock has a wall thickness between about 0.004 in and about 0.010 in.
105. The system of claim 84 wherein the collar further comprises a coating selected from the group consisting of biologically inert and biologically reactive materials.
106. The system of claim 84 wherein the collar comprises a wireform.
107. The system of claim 106 wherein the wireform is produced by a method selected from the group consisting of electron discharge machining, mechanical cutting, laser cutting, laser drilling, water-jet cutting, and chemically etching.
108. The system of claim 106 wherein the wireform is comprised of a singular integral structure.
109. The system of claim 106 wherein the wireform is produced from tubing stock or flat stock from which material is removed.
110. An integral anastomosis connector system, comprising: a fitting comprising a base adapted for attachment to a graft, a leading segment adapted for introduction into a host vessel, and a trailing segment having a proximal end and a distal end; a collar comprising a distal band member which is extendable around the graft from an elongate heel segment, the distal band member being adapted to urge the graft against the fitting; a first hinge defined between the leading segment and the base, wherein the first hinge is adapted to deflect the leading segment relative to the base when securing the graft to the fitting; and a second hinge defined between the collar and the base.
111. The system of claim 110 further comprising at least one pin extending from the fitting, the at least one pin being adapted to secure an everted end of the graft to the fitting.
112. The system of claim 110 wherein each of the first and second hinges has a variable stiffness and spring constant.
113. The system of claim 110 wherein the heel segment is adapted to compress the host vessel against the trailing segment.
114. The system of claim 110 wherein the distal end of the trailing segment is adapted to extend through a first area the graft such that the graft is at least partially secured to the fitting.
115. The system of claim 110 further comprising at least one lateral portion extending between the proximal end of the trailing segment to the leading segment.
116. The system of claim 110 wherein the trailing segment is deflectable from a first position to a second position such that at least the leading segment and the trailing segment can be advanced into the host vessel.
117. The system of claim 116 wherein the trailing segment is adapted to return to the first position after being advanced into the host vessel such that retraction from the host vessel is inhibited.
118. A connector loading tool system for preparing an anastomosis connector assembly, the system comprising: a loading tool base; an outer frame cartridge comprising a flex region having an integral hinge about which a plurality of pins are attached, the pins being adapted to engage an expandable anastomotic connector collar, and an interlock adapted to secure the outer frame cartridge to the loading tool base; and an inner frame cartridge having a handle with a snap defined thereon for engaging a slidable mount positioned on the loading tool base in apposition to the outer frame cartridge, the inner frame cartridge being adapted to engage an anastomotic fitting which is configured to receivingly engage the expandable connector collar; wherein the loading tool base is configured to advance the inner frame cartridge towards the outer frame cartridge until the expandable connector collar is engaged with the fitting.
119. The tool system of claim 118 wherein the loading tool base further comprises a lever adapted to expand the connector collar when actuated.
120. The tool system of claim 118 wherein the outer frame cartridge further comprises a removable mating insert adapted to stabilize and mate with the pins.
121. The tool system of claim 118 further comprising an elongate pusher tool adapted to secure the connector collar to the fitting.
122. The tool system of claim 118 wherein the connector collar expands via an expansion spring to receivingly engage the fitting therewithin.
123. The tool system of claim 122 wherein the connector collar expands between 0.070 in to 0.150 in via the expansion spring.
124. The tool system of claim 122 wherein the connector collar engages the fitting via complementary tabs positioned on the fitting.
125. An anastomosis deployment tool assembly, comprising: a handle block having at least one actuator positioned therewithin; an elongate shell attached at a distal end of the handle block, the shell defining a lumen therethrough; an elongate rod having a proximal end, a distal end, and a length therebetween, the proximal end being positioned within the handle block and pivotally connected to the at least one actuator such that movement of the actuator conespondingly advances the rod within the shell lumen; a biasing mechanism located within the handle block which is adapted to bias the rod in a non-advanced position relative to the shell; a stabilizer attached to a distal end of the shell, wherein the stabilizer defines a first and a second pivot; and a first deflector rotatably attached to the first pivot of the stabilizer and a second deflector rotatably attached to the second pivot of the stabilizer; wherein advancing the rod distally through the shell actuates movement of the first deflector and the second deflector.
126. The deployment tool assembly of claim 125 wherein the actuator comprises at least one linkage having a proximal end attached to at least one handle and a distal end attached to the rod, wherein the linkage passes through an opening defined by the handle block.
127. The deployment tool assembly of claim 126 wherein the handle is pivotally attached to the handle block.
128. The deployment tool assembly of claim 125 wherein the rod defines a lumen therethrough such that the distal end of the rod is in fluid communication with the proximal end of the rod.
129. The deployment tool assembly of claim 125 wherein the rod and shell are adapted to conform to an arbitrary shape defined along each length.
130. The deployment tool assembly of claim 125 wherein the biasing mechanism comprises a compression spring positioned within the handle block coaxially about the rod.
131. The deployment tool assembly of claim 125 further comprising a locking mechanism for preventing movement of the rod relative to the shell.
132. The deployment tool assembly of claim 125 wherein each of the first and the second deflectors are attached to the stabilizer via pins.
133. The deployment tool assembly of claim 125 wherein the first deflector is actuated via a first intermediate linkage and the second deflector is actuated via a second intermediate linkage, each of the intermediate linkages being connected to the distal end of the rod.
134. The deployment tool assembly of claim 125 wherein the first deflector is actuated prior to the second deflector being actuated.
135. The deployment tool assembly of claim 125 wherein the first deflector and the second deflector are actuated simultaneously.
136. An anastomosis connector placement tool comprising: a handle portion; and an active portion having at least a first and a second extension extending from the handle portion, wherein the first extension is adapted to engage a trailing segment of an anastomosis connector and the second extension is adapted to engage an expandable collar of the connector and manipulate the collar via actuation of the handle portion.
137. The placement tool of claim 136 further comprising a stabilization bar integrated between the extensions.
138. The placement tool of claim 136 wherein the handle portion is rotatable relative to the active portion via a pivot connecting the portions.
139. The placement tool of claim 136 further comprising a spring connected between two members of the handle portion for providing a biasing force to the active portion.
EP20020749734 2001-07-05 2002-07-01 Distal anastomosis system Withdrawn EP1408851A2 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
US09899346 US6626920B2 (en) 2001-07-05 2001-07-05 Distal anastomosis system
US899346 2001-07-05
US33327601 true 2001-11-14 2001-11-14
US333276P 2001-11-14
US09991469 US6858035B2 (en) 2001-07-05 2001-11-21 Distal anastomosis system
US991469 2001-11-21
US10122075 US6972023B2 (en) 2001-07-05 2002-04-11 Distal anastomosis system
US122075 2002-04-11
US38782402 true 2002-06-10 2002-06-10
US387824P 2002-06-10
PCT/US2002/020846 WO2003005698A3 (en) 2001-07-05 2002-07-01 Distal anastomosis system

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Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7182771B1 (en) 2001-12-20 2007-02-27 Russell A. Houser Vascular couplers, techniques, methods, and accessories
US7922733B2 (en) 2005-03-04 2011-04-12 Newman Medical Kft Device for end-to-side anastomosis
US9662116B2 (en) 2006-05-19 2017-05-30 Ethicon, Llc Electrically self-powered surgical instrument with cryptographic identification of interchangeable part
US8579176B2 (en) 2005-07-26 2013-11-12 Ethicon Endo-Surgery, Inc. Surgical stapling and cutting device and method for using the device
US9554803B2 (en) 2005-07-26 2017-01-31 Ethicon Endo-Surgery, Llc Electrically self-powered surgical instrument with manual release
US8627995B2 (en) 2006-05-19 2014-01-14 Ethicon Endo-Sugery, Inc. Electrically self-powered surgical instrument with cryptographic identification of interchangeable part
US8038046B2 (en) 2006-05-19 2011-10-18 Ethicon Endo-Surgery, Inc. Electrical surgical instrument with optimized power supply and drive

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6152937A (en) * 1998-11-06 2000-11-28 St. Jude Medical Cardiovascular Group, Inc. Medical graft connector and methods of making and installing same

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO03005698A2 *

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WO2003005698A2 (en) 2003-01-16 application
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WO2003005698A3 (en) 2003-10-02 application
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