WO2003005698A2 - Distal anastomosis system - Google Patents
Distal anastomosis system Download PDFInfo
- Publication number
- WO2003005698A2 WO2003005698A2 PCT/US2002/020846 US0220846W WO03005698A2 WO 2003005698 A2 WO2003005698 A2 WO 2003005698A2 US 0220846 W US0220846 W US 0220846W WO 03005698 A2 WO03005698 A2 WO 03005698A2
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- WO
- WIPO (PCT)
- Prior art keywords
- fitting
- collar
- graft
- segment
- connector
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/0206—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with antagonistic arms as supports for retractor elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B2017/0237—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for heart surgery
- A61B2017/0243—Surgical 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
Definitions
- FIELD OF THE INVENTION 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.
- 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.
- 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.
- 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.
- in-flow anastomoses are required along the main "feeder" graft and out-flow anastomoses are required to the host vessel coronary arteries.
- 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.
- the outer diameter of the aorta where a proximal anastomosis may be located ranges between about 20 mm and about 50 mm in size.
- 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.
- 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.
- 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.
- 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.
- a fitting may alone serve as a connector between a host vessel and a graft.
- 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.
- connectors and deployment devices are preferably used in peripheral and coronary artery bypass grafting procedures, particularly at a distal (out- flow) or proximal (in-flow) location
- 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.
- 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.
- Figure 1 shows a side view of an installed fitting.
- Figure 2 shows a side view of another installed fitting, this connector including a collar for securing the graft shown to a fitting.
- 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.
- Figures 4A and 4B show side and end views of a collar as may be used according to that shown in Figure 2.
- 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.
- Figure 6 shows a side-sectional view of the installed connector and collar in Figure 5.
- 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.
- 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.
- 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.
- Figures 10a and 1 Ob-show side and top views of the collar in Figures
- Figures 11a and 1 lb show bottom views of two fitting variations thermally formed to accommodate different graft to host vessel inner diameter ratios.
- 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.
- Figures 12a to 12c show side views of graft vessels as they may be prepared.
- Figure 13a shows an oblique view of a guide tool for preparing a graft vessel.
- Figure 13b shows a panel of measurement grafts useful to determine an appropriate length for the graft vessel to be prepared.
- Figures 14a to 14c show oblique, top and bottom views of a connector fitting variation at an intermediate stage of manufacture.
- Figures 15a and 15b, 16a and 16b, and 17 to 20 show projected views of optional fitting features.
- Figures 21a and 21b, 22a and 22b, 23, 24a to 24c, and 25a and 25b show projected views of optional collar features.
- 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.
- Figure 27 shows a flattened view of the connector in Figures 26a and
- Figure 28 shows a flattened view of an alternative connector embodiment.
- Figures 29a and 29b show side and perspective views of the non- formed connector in Figure 28.
- Figure 30 shows a flattened view of another connector embodiment.
- Figure 31a shows a flattened view of a collar embodiment.
- Figures 31b and 31c show side and perspective views of the collar embodiment in Figure 31a.
- Figures 32a and 32b show side and perspective views of another collar embodiment.
- Figure 33 shows a flattened view of an alternative collar embodiment.
- 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.
- 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.
- Figures 36a and 36b show a single-piece connector embodiment.
- Figures 36c shows the hinge locations of the connector in Figures 36a and 36b.
- Figures 36d and 36e show top and side views of the connector in
- Figure 37 shows an oblique view of a variation on a spreader.
- Figure 38 shows an oblique view of a variation on a stabilizer.
- Figure 39a and 39b show side and top views of a spreader specifically adapted to open a collar.
- Figure 40 shows an oblique view of another spreader adapted to open a collar.
- Figure 41a shows a side view of an instrument variation with a head adapted to deploy a connector.
- Figure 41b shows an alternate head configuration for the instrument in
- Figure 41c shows a scissors-type head configuration that may be used with the handle portion of the instrument in Figure 41a.
- Figure 42a shows a connector ready for deployment, restrained in customized Rongeur clamp.
- Figure 42b shows an oblique view of the top of a lower section of the instrument in Figure 42a.
- Figure 42c shows an oblique view of the underside of an upper section of the instrument in figure 42a.
- Figures 43a and 43b show side views of another instrument for deploying a connector, the instrument positioned in retracted and extended states, respectively.
- Figure 44 shows a side view of components to form another instrument for deploying a connector.
- Figure 45 shows an oblique view of a end portion for another instrument for deploying a connector.
- Figures 46a and 46b show the components of a loading tool used to secure a graft between a fitting and a collar.
- Figure 46c shows a perspective view of a loading tool base for use in securing a graft to the fitting and collar.
- Figure 46d shows a perspective view of a pushing tool for use with the loading tool base of Figure 46c.
- 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.
- Figures 48a to 48d show an outer frame (collar) cartridge component of a loading tool embodiment.
- 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.
- Figures 50a and 50b show an exploded view and a detailed view of a deployment tool embodiment.
- Figures 50c and 50d show side-sectional views of the deployment tool embodiment in Figures 50a and 50b.
- 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.
- Figures 52a and 52b show a perspective view and an end view of a repositioning tool.
- Figures 53a and 53b show a perspective view and an end view of a removal/repositioning tool.
- 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.
- 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.
- 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.
- CABG Coronary Artery Bypass Grafting
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- lateral portions (20) are also preferably configured such that they allow fitting (10) to flex with the wall of host vessel (8).
- 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).
- a lateral portion may be provided integrally with a form providing at least part of leading segment (16).
- 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).
- 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).
- 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.
- the connector opening (26) may have a circular bore; alternately, it may be ovalized .
- 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.
- FIG. 1 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).
- hinge section (28) includes only one torsion section (30) on each side of rear segment (18).
- 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.
- a feature such as a cut, break, groove or slit (34) in the material.
- Figures 5 and 6 show another variation of the fitting.
- 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.
- 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.
- 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.
- connection (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.
- the height or amount of material incorporated in the base of the fitting may likewise be varied.
- the connector opening (26) may have an ovalized or elliptical opening to the anastomosis or it may have a circular bore.
- 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.
- 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.
- 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.
- 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.
- the fitting (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.
- a large vessel such as the aorta, iliac, subclavian, carotid artery, femoral artery, or other supplying vessel
- 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
- 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.
- 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.
- 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.
- 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.
- rotation of members (30) in deflecting rear section forward may cause lateral portions (20) to be drawn inward to some extent.
- collar (12) 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.
- optional collar tab(s) or latch(es) (24) may assist in this regard by interfacing with optional fitting tab(s) or latch(es) (22).
- collar (12) may be made to be resihently biased against graft (6) and host vessel to hold it to fitting (10).
- interlocking members (36) 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).
- 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.
- 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.
- the shape of the bore of the collar as shown in Figure 4b should complement that of the fitting.
- 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.
- fitting bore (26) is ovalized, a corresponding shape should be utilized in collar (12).
- Figure 42a shows another collar (12) in combination with a fitting (10).
- 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.
- saphenous veins 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).
- 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.
- 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).
- band (40) is designed to bear down upon a toe portion (48) of graft (6) once inserted into a host vessel (8).
- band (40) 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).
- distal band (40) be flexible.
- a connector according to the present invention including a fitting (10) and collar (12)
- it is preferably manipulated as shown in Figure 42a.
- 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).
- 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.
- 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).
- 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 X A to X A 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.
- FIGS. 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.
- 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).
- the expanding spring members 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.
- 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.
- the shape of the bore of the collar preferably complements that of the fitting.
- 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.
- at least a mating portion of collar (12) is preferably substantially circular as well.
- a corresponding shape is preferably utilized in collar (12).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- connector (4) is preferably installed at an anastomosis site as shown in Figures 1 and 5.
- graft toe (48) preferably overlaps host vessel (8).
- a heel portion (62) may abut, overlap host vessel (8) or leave a slight gap.
- FIG. 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.
- a connector is provided with a collar (12)
- the visible result will resemble that in Figures 2 or 5.
- 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.
- 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.
- Figures 12a to 12c illustrate graft preparation configurations. Graft
- FIG. 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, ⁇ , heel (66) it is able to overlap the host vessel above at least a portion of rear segment (18) upon connector (4) insertion.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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).
- measurement members (78) provide a much more accurate gauge of the proper length of a host vessel since each more realistically spans the distance between target sites.
- each member (78) conforms to anatomy and approximates the angle(s) at one or both anastomosis sites.
- 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.
- 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..
- 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.
- FIG. 15a and 15b show splayed out views of a fitting according to the present invention.
- each flattened form represents a pattern (144) for cutting tube or flat stock to be shaped into a fitting or connector.
- fitting pattern (144) 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.
- flat stock 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 fo ⁇ ned in a fitting made from tube stock to provide such compliance to connector.
- Fitting 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.
- the variation in Figure 15a includes a nonlinear or irregular opening shape, similar to that shown in Figures 14a- 14c.
- 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.
- 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.
- a break at tab (22) is also provided.
- 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.
- 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).
- enlarged end (154) can present clearance challenges in deployment.
- 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.
- 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.
- a fitting according to the pattern shown in Figure 18 includes further distinguishing characteristics.
- rear segment (18) originates in a different manner than shown in connection with the other fittings.
- torsion sections (30) are not provided in connection with base (14) near opening (26) but are positioned adjacent lateral portions (20).
- no medial bend (32) or less bend in segment (18) is required to place rear segment end (154) in position to fulfill its task.
- segment (18) may be flexed outward from the connector body and set in shape by thermal forming by a single cycle.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Figures 22a and 22b depict similar collars, except that additional tabs
- 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 is a distal band shape intended be a mirror or complement the front portion of a matching fitting.
- 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.
- 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.
- bridge elements 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.
- the placement of the elements also results in different stiffness of band sections (176) and (178).
- the function of the connector 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.
- 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.
- the graft toe 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- FIGS 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).
- 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).
- 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).
- a graft member (6) of sufficient length may be obtained. Typically this will be a saphenous vein.
- 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 e.g. pericardium, submucosa, etc.
- 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.
- 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.
- 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.
- 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.
- 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.
- fitting (10) In placing fitting (10) into graft (6), it is to be set in relation to collar
- 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.
- a proximal connector 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.
- FIG. 12 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.
- 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).
- Advancing graft (6) through collar (12) may be accomplished with an elongate, low profile clamp or forceps to pull graft through the expanded collar.
- 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.
- 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.
- graft (6) may be trimmed to more closely conform to the shape of connector elements, particularly the distal band (39) of the collar (12).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- the deployment device in Figures 43a and 43b includes a primary handle (106) and an actuator handle (108).
- 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.
- 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.
- Figure 44 shows another type of deployment device (52).
- 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).
- 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).
- 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.
- an angled anastomosis site is prepared by creating an initial puncture, for instance, with the tip of a number 11 blade scalpel.
- 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.
- 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.
- FIG. 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.
- arms (142) of a spreader (92) as shown in figure 7.
- the deployment tool in Figures 50a-50d, 51a, and 51b incorporated pins (270) that may engage the ears (37) of the collar.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- the handle segment (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 CO 2 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.
- 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.
- the rod and/or shell may be made malleable to enable the operator to tailor the deployment tool to his/her access viewpoint.
- a compression spring (254) provides resistance to advancing the rod
- 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.
- a locking mechanism may be incorporated in the deployment tool to ensure the handle does not accidentally actuate.
- 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.
- 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.
- the stabilizer is configured to orient the toe of the connector at approximately 90 degrees to the shell.
- the stabilizer is configured to orient the heel of the connector at an acute angle ( ⁇ 90 degrees) to the shell.
- 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).
- 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.
- 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.
- Bioglue e.g., as available through Cryolife in Kemiesaw, GA
- 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).
- 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,
- 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
- 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.
- the machining may be accomplished by electron discharge machining
- 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.
- connector elements are made from a metal (e.g., titanium) or metal alloy (e.g., stainless steel or nickel titanium).
- 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.
- 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.
- 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.
- 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.
- thromboresistance substances e.g., glycoprotein Ilb/iIIa inhibitors
- antiproliferative substances e.g., rapamycin
- 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.
- 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.
- NiTi (Nitinol) tubing or flat stock may be used to produce connector components.
- 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 A f for at about -10 to - 15°C. Consequently, for typical handling and in use, the material will exhibit superelastic properties as is most desired.
- 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.
- 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.
- fitting (10) and collar (12) may be made of more typical materials such as stainless steel or plastic.
- 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.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2002320230A AU2002320230A1 (en) | 2001-07-05 | 2002-07-01 | Distal anastomosis system |
EP02749734A EP1408851A2 (en) | 2001-07-05 | 2002-07-01 | Distal anastomosis system |
CA002450407A CA2450407A1 (en) | 2001-07-05 | 2002-07-01 | Distal anastomosis system |
JP2003511527A JP2004534585A (en) | 2001-07-05 | 2002-07-01 | Distal anastomosis system |
Applications Claiming Priority (10)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/899,346 | 2001-07-05 | ||
US09/899,346 US6626920B2 (en) | 2001-07-05 | 2001-07-05 | Distal anastomosis system |
US33327601P | 2001-11-14 | 2001-11-14 | |
US60/333,276 | 2001-11-14 | ||
US09/991,469 | 2001-11-21 | ||
US09/991,469 US6858035B2 (en) | 2001-07-05 | 2001-11-21 | Distal anastomosis system |
US10/122,075 US6972023B2 (en) | 2001-07-05 | 2002-04-11 | Distal anastomosis system |
US10/122,075 | 2002-04-11 | ||
US38782402P | 2002-06-10 | 2002-06-10 | |
US60/387/824 | 2002-06-10 |
Publications (2)
Publication Number | Publication Date |
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WO2003005698A2 true WO2003005698A2 (en) | 2003-01-16 |
WO2003005698A3 WO2003005698A3 (en) | 2003-10-02 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2002/020846 WO2003005698A2 (en) | 2001-07-05 | 2002-07-01 | Distal anastomosis system |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP1408851A2 (en) |
JP (1) | JP2004534585A (en) |
AU (1) | AU2002320230A1 (en) |
CA (1) | CA2450407A1 (en) |
WO (1) | WO2003005698A2 (en) |
Cited By (7)
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 |
WO2006092724A3 (en) * | 2005-03-04 | 2007-03-08 | I & S Idee & Sviluppo S R L | Device for end-to-side anastomosis |
US8579176B2 (en) | 2005-07-26 | 2013-11-12 | Ethicon Endo-Surgery, Inc. | Surgical stapling and cutting device and method for using the device |
US9622744B2 (en) | 2006-05-19 | 2017-04-18 | Ethicon Endo-Surgery, Llc | Electrical surgical instrument with one-handed operation |
US9662116B2 (en) | 2006-05-19 | 2017-05-30 | Ethicon, Llc | Electrically self-powered surgical instrument with cryptographic identification of interchangeable part |
US10314583B2 (en) | 2005-07-26 | 2019-06-11 | Ethicon Llc | Electrically self-powered surgical instrument with manual release |
US10314592B2 (en) | 2006-05-19 | 2019-06-11 | Ethicon Llc | Electrically self-powered surgical instrument with cryptographic identification of interchangeable part |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9554803B2 (en) | 2005-07-26 | 2017-01-31 | Ethicon Endo-Surgery, Llc | Electrically self-powered surgical instrument with manual release |
Citations (1)
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 |
-
2002
- 2002-07-01 CA CA002450407A patent/CA2450407A1/en not_active Abandoned
- 2002-07-01 JP JP2003511527A patent/JP2004534585A/en active Pending
- 2002-07-01 EP EP02749734A patent/EP1408851A2/en not_active Withdrawn
- 2002-07-01 WO PCT/US2002/020846 patent/WO2003005698A2/en not_active Application Discontinuation
- 2002-07-01 AU AU2002320230A patent/AU2002320230A1/en not_active Abandoned
Patent Citations (1)
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 |
Cited By (23)
Publication number | Priority date | Publication date | Assignee | Title |
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US7182771B1 (en) | 2001-12-20 | 2007-02-27 | Russell A. Houser | Vascular couplers, techniques, methods, and accessories |
WO2006092724A3 (en) * | 2005-03-04 | 2007-03-08 | I & S Idee & Sviluppo S R L | Device for end-to-side anastomosis |
US7922733B2 (en) | 2005-03-04 | 2011-04-12 | Newman Medical Kft | Device for end-to-side anastomosis |
US9848872B2 (en) | 2005-07-26 | 2017-12-26 | Ethicon Llc | Surgical stapling and cutting device |
US8579176B2 (en) | 2005-07-26 | 2013-11-12 | Ethicon Endo-Surgery, Inc. | Surgical stapling and cutting device and method for using the device |
US8695865B2 (en) | 2005-07-26 | 2014-04-15 | Ethicon Endo-Surgery, Inc. | Surgical stapling and cutting device |
US8920435B2 (en) | 2005-07-26 | 2014-12-30 | Ethicon Endo-Surgery, Inc. | Method for operating a surgial stapling and cutting device |
US11234695B2 (en) | 2005-07-26 | 2022-02-01 | Cilag Gmbh International | Surgical stapling and cutting device |
US11172930B2 (en) | 2005-07-26 | 2021-11-16 | Cilag Gmbh International | Electrically self-powered surgical instrument with manual release |
US10314583B2 (en) | 2005-07-26 | 2019-06-11 | Ethicon Llc | Electrically self-powered surgical instrument with manual release |
US9855038B2 (en) | 2005-07-26 | 2018-01-02 | Ethicon Llc | Surgical stapling and cutting device |
US9687234B2 (en) | 2006-05-19 | 2017-06-27 | Ethicon L.L.C. | Electrical surgical instrument with optimized power supply and drive |
US9757127B2 (en) | 2006-05-19 | 2017-09-12 | Ethicon Llc | Electrical surgical instrument with optimal tissue compression |
US9713473B2 (en) | 2006-05-19 | 2017-07-25 | Ethicon Endo-Surgery, Inc. | Active braking electrical surgical instrument and method for braking such an instrument |
US9681873B2 (en) | 2006-05-19 | 2017-06-20 | Ethicon Llc | Electrical surgical stapling instrument with tissue compressive force control |
US9901340B2 (en) | 2006-05-19 | 2018-02-27 | Ethicon Endo-Surgery, Inc. | Active braking electrical surgical instrument and method for braking such an instrument |
US9675348B2 (en) | 2006-05-19 | 2017-06-13 | Ethicon Llc | Electrical surgical instrument with knife return |
US10314592B2 (en) | 2006-05-19 | 2019-06-11 | Ethicon Llc | Electrically self-powered surgical instrument with cryptographic identification of interchangeable part |
US10675022B2 (en) | 2006-05-19 | 2020-06-09 | Ethicon Llc | Electrical surgical instrument with optimal tissue compression |
US11172931B2 (en) | 2006-05-19 | 2021-11-16 | Cilag Gmbh International | Electrically self-powered surgical instrument with cryptographic identification of interchangeable part |
US9662116B2 (en) | 2006-05-19 | 2017-05-30 | Ethicon, Llc | Electrically self-powered surgical instrument with cryptographic identification of interchangeable part |
US9622744B2 (en) | 2006-05-19 | 2017-04-18 | Ethicon Endo-Surgery, Llc | Electrical surgical instrument with one-handed operation |
US11759203B2 (en) | 2006-05-19 | 2023-09-19 | Cilag Gmbh International | Electrical surgical instrument with minimum closure distance for staple firing control |
Also Published As
Publication number | Publication date |
---|---|
WO2003005698A3 (en) | 2003-10-02 |
EP1408851A2 (en) | 2004-04-21 |
JP2004534585A (en) | 2004-11-18 |
CA2450407A1 (en) | 2003-01-16 |
AU2002320230A1 (en) | 2003-01-21 |
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