Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
1999-03-17
2003-09-09
Thaler, Michael H. (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S153000
Reexamination Certificate
active
06616675
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical devices, and more particularly to methods and apparatus for making connections between blood vessels or other adjacently situated anatomical or synthetic structures having hollow lumens or cavities formed therein.
BACKGROUND OF THE INVENTION
In modern medical practice, it is often desirable to form connections between adjacent anatomical passageways, or between adjacent segments of a single anatomical passageway. The types of anatomical passageways between which such connections may be made include; blood vessels, vas deferens, fallopian tubes, intestines, lymphatic ducts, grafts, ventricular cavities of the heart or brain, etc.
Recently, applicant has devised certain in situ vascular bypass procedures wherein blood flow passageways (e.g., puncture tracts or interstitial tunnels) are formed between the lumens adjacently situated blood vessels (e.g., between an obstructed coronary artery and an adjacent coronary vein) to bypass a diseased, injured or obstructed segment of one blood vessel. These procedures have previously been described in U.S. patent application Ser. Nos. 08/730,327 and 08/730,496. Also, Provisional U.S. Patent Application Ser. No. 60/010,614 particularly describes certain minimally invasive vascular grafting procedures devised by applicant for by-passing an obstructed artery. In these grafting procedures, a tubular graft (e.g., a segment of an endogenous blood vessel or a tube graft formed of natural or synthetic material) is maneuvered into juxtaposition with the obstructed artery. One or more openings are formed in the graft and the adjacent artery. The openings formed in the graft are then connected to the openings formed in the artery, such that blood may flow between the graft and the artery.
Additionally, various procedures have been reported by others wherein implantable apparatus are used to connect or facilitate flow of bodily fluid between anatomical passageways (e.g., genitourinary ducts). One such procedure is described in U.S. Pat. No. 3,042,021 (Read) entitled BYPASS TYPE INSERT PLUG FOR BODY PASSAGEWAY.
To facilitate the connection of adjacently situated anatomical structures, as in the above-mentioned medical procedures, there exists a need in the art for the design and development of new connector apparatus which may be implanted, through transluminal catheters or probes, to form a secure connection between openings formed in adjacently situated anatomical structures and/or to maintain such openings in direct alignment and/or fluidic communication with each other.
SUMMARY OF THE INVENTION
The present invention provides apparatus for connecting or joining a first opening formed in a first anatomical structure of the type having a hollow inner space or lumen (e.g., a blood vessel, a hollow organ, a chamber of the heart, a vascular graft, etc.) with a second opening formed in a second anatomical structure which also has a hollow innerspace of similar type. In general, these connecting apparatus comprise a) a first engagement member which is engageable with the first anatomical structure, b) a second engagement member which is engageable with the second anatomical structure, and c) a connecting portion which extends or traverses between the first and second engagement members, and serves to hold the openings formed in the first and second anatomical structures in the desired alignment, typically, such that fluid may pass from one anatomical structure into the other.
Further in accordance with the invention, the connecting apparatus may be initially deployable in a radially compact state such that it may be advanced transluminally through the body to a desired implantation site, and is subsequently transitionable to a radially expanded configuration wherein the first engagement member will engage the first anatomical structure and the second engagement member will engage the second anatomical structure. Additionally or alternatively, the first and second engagement members may be initially deployed in non-operative positions (e.g., extending generally parallel to the longitudinal axis of the apparatus) to facilitate transluminal passage and/or placement of the apparatus at the desired implantation site. Thereafter, the first and second engagement members may be transitionable to a second configuration (e.g., an outwardly splayed configuration) such that the first and second engagement members will engage the first and second anatomical structures, as desired. In this manner, the apparatus may be self expanding or self splaying (e.g., formed of resilient or shape memory material) such that the radial expansion or transitioning of the engagement members will occur when surrounding constraint (e.g., constraint of a surrounding catheter wall) has been removed from the apparatus. Alternatively, the apparatus may be plastically deformable and provided with a pressure-exerting tool (e.g., a balloon) which will plastically deform the apparatus to cause the desired radial expansion and/or transitioning of the engagement members after the apparatus has been positioned in its desired implantation site.
Further in accordance with the invention, the engagement members may comprise wire loops, wire members, flanges, extensions, tongues, or any other suitable type of member which will embed into or otherwise engage the adjacent surface of an anatomical structure so as to hold the apparatus at its desired implantation site and/or to maintain the patency of the passageway as well as the length of the connection.
Still further in accordance with the invention, the connecting portion of the apparatus may comprise one or more elongate strands or members, a solid or perforated tube, or any other suitable connecting portion which will serve to link or connect the first and second engagement members and hold them at their desired spaced-apart distance. In some embodiments, the connecting portion may be elastic or biased so as to exert continual pulling force or retraction against the first and second engagement members. In other embodiments, the connecting portion may be rigid and non-elastic so as to remain at a fixed non-alterable length. Additionally, in some embodiments, the connecting portion may define a cylindrical or annular support member which will dilate, support or otherwise maintain any surrounding interstitial tissue in a desired configuration so as to prevent blockage or non-patency of the flow path formed between the first and second openings in the first and second anatomical structures.
Additionally, the connecting portion may be constructed to maintain a minimum passageway diameter between the openings in the first and second anatomical structures. Also, the connecting portion may be constructed to perform some surface modeling or customization of the surrounding tissue as by mechanical pressure exertion, application of a coating or chemical treatment, xenograft, emission of energy, etc. In this manner, the delivery catheter or delivery system used to facilitate implantation of the correct connector apparatus may by equipped with wires, or other energy transmitting members which are in contact with the connector apparatus and which will deliver energy into the connector apparatus, thereby using the connector apparatus as an energy-transferring member for causing deburring, enlargement, scarring, or other modification of the surrounding tissue with which the connector comes in contact. Examples of the types of energy which may be useable for this purpose include electrical energy, radiofrequency, ultrasound, radiation (e.g, beta, gamma, etc.), etc.
Still further in accordance with the invention, the connecting portion of the apparatus may be elastic, adjustable, telescoping, distendible or of accordion construction, etc., so as to adjust or conform to passageways of differing length. This aspect of the invention will allow a connector apparatus to be used for applications wherein the distance between the first and second openings in the first and second anatomical structures may
Evard Philip C.
Flaherty J. C.
Garibotto John T.
Macaulay Patrick E.
Machold Timothy R.
Buyan Robert D.
Stout, Uxa Buyan & Mullins, LLP
Thaler Michael H.
Transvascular, Inc.
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