MXPA98006192A - Methods and apparatus for connecting openings formed in adjacent blood vessels or other anatomy structures - Google Patents
Methods and apparatus for connecting openings formed in adjacent blood vessels or other anatomy structuresInfo
- Publication number
- MXPA98006192A MXPA98006192A MXPA/A/1998/006192A MX9806192A MXPA98006192A MX PA98006192 A MXPA98006192 A MX PA98006192A MX 9806192 A MX9806192 A MX 9806192A MX PA98006192 A MXPA98006192 A MX PA98006192A
- Authority
- MX
- Mexico
- Prior art keywords
- connector
- tube
- coupling
- coil
- longitudinal axis
- Prior art date
Links
- 210000003484 anatomy Anatomy 0.000 title claims description 65
- 210000004204 Blood Vessels Anatomy 0.000 title abstract description 107
- 230000001808 coupling Effects 0.000 claims description 129
- 238000010168 coupling process Methods 0.000 claims description 129
- 238000005859 coupling reaction Methods 0.000 claims description 129
- 239000000463 material Substances 0.000 claims description 38
- 210000001519 tissues Anatomy 0.000 claims description 36
- 239000007943 implant Substances 0.000 claims description 25
- 239000011248 coating agent Substances 0.000 claims description 5
- 238000000576 coating method Methods 0.000 claims description 5
- 239000002184 metal Substances 0.000 claims description 5
- 229910052751 metal Inorganic materials 0.000 claims description 5
- 239000004033 plastic Substances 0.000 claims description 5
- 229920003023 plastic Polymers 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 3
- 229910045601 alloy Inorganic materials 0.000 claims description 2
- 239000000956 alloy Substances 0.000 claims description 2
- REDXJYDRNCIFBQ-UHFFFAOYSA-N aluminium(3+) Chemical class [Al+3] REDXJYDRNCIFBQ-UHFFFAOYSA-N 0.000 claims description 2
- 230000000845 anti-microbial Effects 0.000 claims description 2
- 230000002965 anti-thrombogenic Effects 0.000 claims description 2
- 230000002285 radioactive Effects 0.000 claims description 2
- 210000001513 Elbow Anatomy 0.000 claims 5
- 239000003146 anticoagulant agent Substances 0.000 claims 1
- 239000004599 antimicrobial Substances 0.000 claims 1
- 230000001404 mediated Effects 0.000 claims 1
- 230000002537 thrombolytic Effects 0.000 claims 1
- 239000002759 woven fabric Substances 0.000 claims 1
- 210000001124 Body Fluids Anatomy 0.000 abstract description 8
- 239000010839 body fluid Substances 0.000 abstract description 8
- 210000001367 Arteries Anatomy 0.000 description 10
- 210000004369 Blood Anatomy 0.000 description 10
- 239000008280 blood Substances 0.000 description 10
- 241000952661 Banana virus X Species 0.000 description 9
- 238000000034 method Methods 0.000 description 8
- 239000012530 fluid Substances 0.000 description 7
- 238000004519 manufacturing process Methods 0.000 description 6
- 230000004048 modification Effects 0.000 description 6
- 238000006011 modification reaction Methods 0.000 description 6
- 210000002216 Heart Anatomy 0.000 description 5
- 210000003462 Veins Anatomy 0.000 description 4
- 230000036760 body temperature Effects 0.000 description 4
- 230000004301 light adaptation Effects 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 238000010276 construction Methods 0.000 description 3
- 230000000875 corresponding Effects 0.000 description 3
- 239000004744 fabric Substances 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 230000000717 retained Effects 0.000 description 3
- 235000004418 Durio kutejensis Nutrition 0.000 description 2
- 230000004075 alteration Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 230000022534 cell killing Effects 0.000 description 2
- 238000005520 cutting process Methods 0.000 description 2
- 230000009089 cytolysis Effects 0.000 description 2
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 description 2
- 238000005755 formation reaction Methods 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 230000017074 necrotic cell death Effects 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 2
- 239000004810 polytetrafluoroethylene Substances 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 230000035755 proliferation Effects 0.000 description 2
- 230000002829 reduced Effects 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 238000004804 winding Methods 0.000 description 2
- 210000004556 Brain Anatomy 0.000 description 1
- 210000004351 Coronary Vessels Anatomy 0.000 description 1
- 229920004934 Dacron® Polymers 0.000 description 1
- 210000001308 Heart Ventricles Anatomy 0.000 description 1
- 210000000936 Intestines Anatomy 0.000 description 1
- 210000001503 Joints Anatomy 0.000 description 1
- 210000000088 Lip Anatomy 0.000 description 1
- 210000002751 Lymph Anatomy 0.000 description 1
- 210000004165 Myocardium Anatomy 0.000 description 1
- 210000003101 Oviducts Anatomy 0.000 description 1
- 239000004698 Polyethylene (PE) Substances 0.000 description 1
- 206010039509 Scab Diseases 0.000 description 1
- 210000001177 Vas Deferens Anatomy 0.000 description 1
- 230000001070 adhesive Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000002924 anti-infective Effects 0.000 description 1
- UIMGJWSPQNXYNK-UHFFFAOYSA-N azane;titanium Chemical class N.[Ti] UIMGJWSPQNXYNK-UHFFFAOYSA-N 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000023298 conjugation with cellular fusion Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229920002457 flexible plastic Polymers 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000000004 hemodynamic Effects 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- 230000013011 mating Effects 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000004118 muscle contraction Effects 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 230000000414 obstructive Effects 0.000 description 1
- 210000000056 organs Anatomy 0.000 description 1
- 230000036961 partial Effects 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- -1 polytetrafluoroethylene Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 230000003014 reinforcing Effects 0.000 description 1
- 230000002441 reversible Effects 0.000 description 1
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 230000021037 unidirectional conjugation Effects 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Abstract
The present invention relates to methods and apparatuses for connecting two anatomical passages, such as blood vessels, in a collateral manner. Openings are formed in the sidewalls of the passages and a connecting apparatus (10) of the present invention is implanted within such openings, and extends between the passages or blood vessels (BV1) (BV2) to connect the passages or blood vessels ( BV1) (BV2) in such a way that the openings are maintained in direct alignment with each other, by which the body fluids are allowed to pass from a passageway to the ot
Description
METHODS AND APPARATUS FOR CONNECTING OPENINGS FORMED IN ADJACENT BLOOD VESSELS OR OTHER ANATOMICAL STRUCTURES
Field of the Invention
The present invention relates in general to medical devices, and more particularly to methods and apparatuses for establishing connections between blood vessels or other adjacent synthetic or anatomical structures, having lumens or hollow cavities formed therein.
Background of the Invention
In modern medical practice, it is often desirable to form connections between adjacent anatomical passages, or between adjacent segments of a single anatomical passageway. The types of anatomical passages between which such connections can be made include; blood vessels, vas deferens, fallopian tubes, intestines, lymph ducts, grafts, ventricular cavities of the heart or brain, etc.
Ref.028001 Recently, the applicant has contemplated certain referral procedures wherein blood flow passages (eg, puncture tracts or interstitial tunnels) are formed between the lumens located adjacent to the blood vessels (e.g. between an obstructed coronary artery and an adjacent coronary vein) to derive a diseased, damaged or obstructed segment from a blood vessel. These procedures have previously been described in the U.S. Patent Applications Nos. 08 / 730,327 and 08 / 730,496. Also, U.S. Patent Application Serial No. 60 / 010,614 particularly discloses certain vascular graft procedures contemplated by the applicant to derive an obstructed artery. In these graft procedures, a tubular graft (eg, a segment of an endogenous blood vessel or a tubular graft formed of natural or synthetic material) is manipulated in juxtaposition with the obstructed artery. One or more openings are formed in the graft and in the adjacent artery. The openings formed in the graft are then connected to the openings formed in the artery, in such a way that the blood can flow between the graft and the artery. Additionally, several procedures have been reported by other people where the implantable devices are used to connect or facilitate the flow of body fluid between the anatomical passages (for example, the genitourinary ducts). One such method is described in U.S. Patent No. 3,042,021 (Read) entitled BYPASS TYPE INSERT PLUG FOR BODY PASSAGEWAY. To facilitate the connection of adjacent anatomical structures, as in the medical procedures mentioned above, there is a need in the art for the design and development of a new connector apparatus which can be implanted, by means of transluminal catheters or probes, to form a secure connection between the openings formed in the anatomical structures located adjacently and / or to maintain such openings in direct alignment and / or fluid communication with each other.
Brief Description of the Invention
The present invention provides an apparatus for connecting or joining a first aperture formed in a first anatomical structure of the type having a hollow internal space or lumen (e.g., a blood vessel, a hollow organ, a heart chamber, a vascular graft, etc.) with a second opening formed in a second anatomical structure which also has a hollow interspace of a similar type. In general, these connecting devices comprise: a) a first anatomical element which is engageable with the first anatomical structure, b) a second coupling element which is engageable with the second anatomical structure, and c) a connecting portion which crosses or extends between the first and second coupling elements, and serves to retain the openings formed in the first and second anatomical structures in the desired alignment, typically, in such a way that the fluid can pass from one anatomical structure to the other. Further in accordance with the invention, the connecting apparatus may be deployable initially in a radially compact state such that it can be transluminally advanced through the body to a desired implant site, and subsequently translatable to an expanded configuration. radially wherein the first coupling element will couple the first anatomical structure and the second coupling element will couple the second anatomical structure. Additionally or alternatively, the first and second coupling elements may be initially deployed in non-operative positions (eg, extending generally parallel to the longitudinal axis of the apparatus) to facilitate transluminal passage and / or placement of the apparatus at the desired implant site. . After this, the first and second coupling elements can be translatable to a second configuration (eg, an outwardly extended configuration) such that the first and second coupling elements will couple the first and second anatomical structures, when desired . In this way, the apparatus can be self-expanding or self-expanding (eg, formed of elastic material or with a shape memory) such that the expansion or radial transition of the coupling elements will occur when the surrounding constraints (e.g. the restriction of a surrounding catheter wall) have been removed from the apparatus. Alternatively, the apparatus may be plastically deformable and provided with a pressurizing tool (e.g., a balloon) which will plastically deform the apparatus to cause the desired transition and / or radial expansion of the coupling elements after the apparatus has been placed in your desired implant site. Further according to the invention, the coupling elements may comprise wire loops, wire elements, projections, extensions, tabs, or any other type of suitable element which will be interleaved in or otherwise coupled with the adjacent surface of an anatomical structure for retaining the apparatus at its desired implant site and / or for maintaining the opening 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 elongated cords or elements, a solid or perforated tube, or any other suitable connection portion which will serve to link or connect the first and second elements of the invention. coupling and hold them at their desired spacing distance. In some embodiments, the connection portion may be induced or biased to exert a continuous pulling force or retraction against the first and second coupling elements. In other embodiments, the connection portion may be rigid and non-resilient so that it remains in a fixed, non-alterable length. Additionally, in some embodiments, the connection portion may define an annular or cylindrical support element which will expand, support or otherwise maintain any surrounding interstitial tissue in a desired configuration to prevent blockage or non-opening of the flow path formed between the first and second openings in the first and second anatomical structures. Additionally, the connection portion can be constructed to maintain a minimum passageway diameter between the openings in the first and second anatomical structures. Also, the connection portion can be constructed to effect some modeling or surface adaptation of the surrounding tissue such as to exert a mechanical pressure, the application of a chemical treatment or coating, xenograft, energy emission, etc. In this way, the delivery catheter or the delivery system used to facilitate the implantation of the correct connector apparatus can be equipped with wires, or other energy transmitting elements which are in contact with the connector apparatus and which will supply energy to the connector apparatus, whereby using the connector apparatus as an energy transfer element to cause the scabs to come off, a lengthening, healing, or other modification of the surrounding tissue with which the connecting element comes into contact. Examples of the types of energy that may be usable for this purpose include electric power, radio frequency, ultrasound, radiation (eg, beta, gamma, etc.), etc. Still further according to the invention, the connection portion of the apparatus can be elastic, adjustable, telescopic, extensible or accordion-shaped construction, etc., to fit or conform to the passageways of different length. This aspect of the invention will allow a connecting apparatus to be used for applications where the distance between the first and second openings in the first and second anatomical structures may vary and in each specific application, maintain the first and second anatomical structures at a relatively high tension constant (that is, at a constant force). Alternatively, for the connector apparatus which does not incorporate such longitudinal elasticity, adjustability, telescopic movement capability, extensible configuration or accordion shape, the connector apparatus may be provided in a variety of different lengths and the operator may select the appropriate length of the apparatus connector prior to installation. Still further according to the invention, the leading edge of the apparatus may be a sharp cutting edge or it may be otherwise adapted to cut or separate the tissue, such that the supply and advancement of the apparatus through the openings in the anatomical structures and / or the passage created between them may additionally serve to form such openings or passageways, or to lengthen, adapt, model or otherwise alter the fabric with which it comes into contact.
Still further in accordance with the invention, a connecting apparatus is provided having a connecting portion which comprises the legs or elements which penetrate through the tissue surrounding the openings formed in the anatomical structures and / or any intervening tissue, located therebetween, such that the connecting portion of the apparatus is interspersed within the tissue of the host and is actually located outside the channel or passage formed between the first and second openings in the first and second anatomical openings. Still further in accordance with the invention, supply systems and devices are provided for supplying and implanting the connecting apparatuses of the present invention. These delivery apparatuses and devices are typically incorporated in or mounted on a transluminally advancing catheter, and comprise a retractable cover, an inflatable balloon, a push rod, appropriate shift covers, or rotating elements. which operate radially to expand or advance the connector apparatus to its desired implant position within the body. These and other elements and objects of the present invention will be understood and appreciated more fully during the reading of the detailed description of the preferred embodiments described hereinafter, and by studying the accompanying drawings in which the preferred embodiments are shown.
Brief Description of the Drawings
Figure 1 is a partial longitudinal sectional view of the two blood vessels positioned adjacently, having a passageway for the flow of blood formed therebetween, and a connector apparatus of the present invention implanted within such a passage for the flow of blood. blood, to facilitate and maintain the desired collateral connection between blood vessels. Figure 2 is a perspective view of a roll or coil type connector apparatus of the present invention. Figure 2 'is a perspective view of a modified roll or coil type connector apparatus of the present invention. Figure 2 '' is a perspective view of another modified roll or coil type connector apparatus of the present invention, having an intermediate tubular portion. Figure 2 '' 'is a perspective view of another connecting device of the roll or coil type of the present invention, having an intermediate portion fused. Figure 2"'' 'is a side elevational view of a coil or coil connecting apparatus of the present invention which is biased or tilted toward a flattened or longitudinally collapsed configuration. Figure 3 is a perspective view of the mesh type connector apparatus of the present invention. Figure 3 'is a perspective view of the mesh type connector apparatus of the present invention, having optional coupling elements formed at each end thereof. Figure 3 '' is a perspective view of the mesh type connector apparatus of Figure 3 'where the coupling elements are self-deployable. Figure 3 '' 'is a perspective view of the mesh type connector apparatus of Figure 3' wherein the coupling elements are deployable under pressure, and wherein the apparatus is shown in conjunction with a balloon-shaped catheter which exerts a pressure, which is usable to deploy the coupling elements at the desired implant site.
Figure 4 is a perspective view of a tubular type connector apparatus of the present invention. Figure 4 'of the present invention has optional coupling elements formed on either end thereof. Figure 4 '' is a perspective view of the tubular type connector apparatus shown in Figure 4 ', where the coupling elements are self-deployable. Figure 4 '' 'is a perspective view of the tubular type connector apparatus shown in Figure _', wherein the coupling elements are deployable under pressure, and wherein the apparatus is shown in conjunction with a ball-shaped catheter exerting a pressure, which is usable for the deployment of the coupling elements at the implant site wanted. Figure 5 is a perspective view of a cylindrical connector apparatus of the present invention comprising a solid (non-perforated) tubular element having optional coupling elements on either end thereof. Figure 5 'is a perspective view of a cylindrical, non-hyperbolic connector apparatus, wherein the coupling elements are self-deployable.
Figure 5 '' is a perspective view of a cylindrical connector apparatus in which the coupling elements are deployable under pressure, and wherein the apparatus is shown in conjunction with a ball-shaped catheter which exerts a pressure, which is usable to cause the deployment of the coupling elements at the desired implant site. Figure 5 '' 'is a perspective view of a cylindrical connector apparatus in which the tubular element is formed of wire mesh having a multiplicity of openings or perforations formed therein, and multiple coupling elements are formed on both ends of the tubular element; Figure 5 '' '' is a perspective view of a cylindrical connector apparatus in which the tubular member is formed of wire mesh having a multiplicity of openings or perforations formed therein, and two (2) coupling elements are formed on each end of the tubular element, the coupling elements are in direct alignment with each other; Figure _ • '' '' 'is a perspective view of a cylindrical connector apparatus in which the tubular element is formed of a solid tube, and wherein the coupling elements comprising the semicircular wire projections are mounted on either end of the tubular element; Figure 6 is a perspective view of a two-piece rivet type connector apparatus of the present invention having a first protrusion connection system in a notch formed thereon. Figure 6 'is a perspective view of an alternative two-piece rivet type connector apparatus of the present invention having a tapered friction fit coupling system formed thereon. Figure 6 '' is a perspective view of another alternate two-piece rivet type connector apparatus of the present invention, having a magnetic or protruding coupling system in a notch formed thereon . Figure 7a is a top plan view of a first elastomeric connector apparatus of the present invention comprising a tubular intermediate portion having elastomeric coupling elements formed at either end thereof. Figure 7a 'is a perspective view of the elastomeric connector apparatus of Figure 7a. Figure 7b is a top plan view of another elastomeric connector apparatus of the present invention comprising a tubular intermediate portion having a non-circular lumen and coupling lugs formed at either end thereof. Figure 7b 'is a perspective view of the connector apparatus shown in Figure 7b. Figure 7c is a perspective view of a connector apparatus of the present invention comprising an elastomeric body having wire support elements formed therein. Figure 7d is a perspective view of a wire connector apparatus of the present invention. Figure 7d 'is a perspective view of the wire connector apparatus of Figure 7d having an elastomeric or woven, cylindrical sleeve formed thereon. Figure 7d '' is a perspective view of another wire connecting apparatus formed of two of the connecting apparatuses of Figure 7d, coupled together to form a single apparatus. Figure 8 is a perspective view of a sinusoidal wire connector apparatus of the present invention in a collapsed or collapsed configuration prior to fabrication in its desired final configuration. Figure 8a is a perspective view of the sinusoidal wire connector apparatus of Figure 8 following manufacture in its final desired configuration, and showing the apparatus in a preferred implant position forming a connection between the adjacent tubular anatomical ducts . Figure 9 is a perspective view of a triple coil or coil type connector apparatus of the present invention, which shows the apparatus in a preferred implant position, which forms a connection between the adjacent tubular anatomical conduits. Figure 10 is a longitudinal sectional view of a tubular connector with projections of the present invention, in a preferred implant position, forming a connection between the adjacent tubular anatomical conduits. Figure 10a is a perspective view of a pipe segment which has been pre-cut for fabrication in a tubular connector apparatus with protrusions of Figure 10. Figure 10b is a side elevational view of the segment previously provided with notches of the pipe, shown in Figure 10a. FIGURE LIA is a perspective view of a first embodiment of a connector winding apparatus with projections of the present invention.
FIG. 11b is a perspective view of a second embodiment of a protruding winding connector apparatus of the present invention. Figure 11c is a perspective view of a cylindrical connector apparatus with projections of the present invention. Figure 12 is a perspective view showing the manner in which any of the connecting apparatuses of the present invention can be modified to form a non-perpendicular connection between the adjacent anatomical structures. Figure 13 is a perspective view of a segment of the myocardium showing an alternative application of the connector apparatus of the present invention to form a connection between a coronary blood vessel and a heart chamber. Figure 14a is a schematic view showing a delivery catheter of the retractable cover type usable for supplying the connector apparatus of the present invention. Figure 14b is a schematic view showing an inflatable ball type delivery catheter usable for supplying the connector apparatus of the present invention. Figure 14c is a schematic view showing a supply rod of the push rod type usable for supplying the connector apparatus of the present invention. Figure 14d is a schematic view showing a cover type delivery catheter with an appropriate shift slider, usable for supplying the connector apparatus of the present invention. Figure 14e is a schematic view showing a rotatable supply catheter usable for supplying and implanting the connector apparatus of the present invention. Figure 15a is a view showing a two-piece connector apparatus as described and claimed in original application Serial No. 08 / 730,327, modified to illustrate the manner in which the connecting portion of the connector apparatus can protrude through of the tissue and deposited outside the passageway which has been formed between the adjacent anatomical structures. Figure 15a 'is an exploded view of the connector apparatus shown in Figure 15a.
Detailed Description of the Preferred Modalities
The following detailed description and the drawings to which it refers, are provided for the purpose of describing and illustrating the currently preferred embodiments of the invention, and are not intended to limit the scope of the claims in any way. It is to be understood that each of the attributes of the structural elements and components shown in the drawings for one embodiment may be incorporated in or combined with any or all of the other embodiments of the invention, provided that such a denial may be carried out without denying the usefulness or functionality of this modality. In addition, it will be appreciated that no effort has been made to describe and exhaustively illustrate each and every possible embodiment of the invention that each and every possible design or structural characteristic can be combined with it. Specifically, the following elements, adaptations or structural attributes may be incorporated in any or all of the embodiments described herein, regardless of whether such elements, adaptations or attributes are specifically shown in any of the drawings. 1. Radio-opaque construction or radio-opaque markings to enable the connector to be visualized by fluoroscopy techniques, rays
X or Roentgenographic;
2. Non-obstructive or minimally obstructive to the flow of fluid through the openings in the anatomical structures between which the connection is formed; 3. Non-trogenic or antithrombogenic when used in applications where there is contact with blood and / or anti-infective and antimicrobial and / or radioactive to prevent neointimal growth or natural closure or narrowing of the passage. 4. Capable of resisting the range of pressures which will be found in the proposed anatomical application, such as pressures of 140-180 mmHg in applications where connections between the arteries or between an artery and a vein are formed; 5. Capable of being installed operatively without causing the segmental necrosis or to improve or induce the proliferation of the tissue surrounding the connecting apparatus; 6. Capable of expansion / contraction or adaptation in another way to satisfy or abide by changes between the anatomical structures connected; 7. The portions of the connector apparatus which will butt against or engage the lumenal or internal wall of each anatomical structure can be configured to conform to this lumenal or internal wall (e.g., the coupling elements or protrusions can be shaped cup or semi-cylindrical bulged shape to conform to the shape of the wall of a blood vessel to which the connection is made); 8. The connector apparatus may be structured or designed to maintain a desired cross-sectional dimension or diameter of the openings formed in the adjacent anatomical structures and any interstitial passage formed between such openings; and 9. The connector apparatus may preferably be formed of a single or continuous structural element, which has a minimum probability of rupture or dismemberment after implantation. 10. Able to incorporate a flow control element or valve (e.g., a one-way check valve) to control or maintain a specific flow configuration or type (e.g., unidirectional flow) through the passageway.
11. The connection portion of the connector apparatus can be adapted to form passageways of various shapes (eg, cylindrical, ovoid, arcuate). 12. Able to be removed after the implant. 13. The connecting apparatus may be constructed with varying amounts of structural support or scaffolding, or may incorporate structural or nonstructural elements placed intraluminally which will retard or restrict neointimal growth or natural closure or narrowing of the passage.
14. The connector apparatus will preferably be able to withstand all forces (e.g., hemodynamic pressures, muscle contractions or other forces created by body movement or impact) which will be found following the implant, without resultant adverse effect (e.g. , rupture, disengagement, sliding, movement or other undesirable alteration of the connecting device). 15. The connector apparatus can be constructed and configured so that residual forces are applied to compress or otherwise minimize the length of the passage between the first and second anatomical structures following the implant. 16. The connector apparatus may be adapted to receive and transmit the energy delivered through the delivery apparatus (e.g., the delivery catheter). Such energy can serve to modify the surrounding tissue which defines the openings in the first and second anatomical structures as well as any passage created between the interstitial tissue which resides between the anatomical structures. 17. The connector apparatus may be configured to control or define the geometric shape of the passage to maximize flow performance and / or to minimize adverse flow conditions such as turbulence. 18. The connector apparatus can be constructed to withstand twisting and twisting without adverse effects. With reference to the drawings, Figure 1 provides a general illustration of the manner in which the connector apparatus 10 of the present invention is implanted or installed without openings formed in the adjacent blood vessels BVi, BV2 to maintain the collateral connection and alignment direct from openings in the lateral wall formed in blood vessels BVlf BV2. The blood vessels BVi, BV2 may be endogenous arteries and / or veins in their natural anatomical positions, or they may constitute an endogenous artery or vein having a synthetic or biological tubular graft placed in juxtaposition therewith.
i. Roll or coil connectors
Figures 2-2 '' 'show various variations of a first embodiment 10a of the connector apparatus of the present invention. Each of the variants shown in Figures 2-2 '' 'comprise a roll or helical coil formed of flexible or superelastic wire 12, such roll or coil has opposite ends of a first diameter Di and an intermediate portion of a second diameter D2 . The second diameter D2 of the intermediate portion of the roll or coil is smaller than the first diameter Di of the ends, such that the apparatus 10a is generally of a completely hyperbolic or "hourglass" shape. However, it will be appreciated that other embodiments may also be provided, instead of the hyperbolic or hourglass shape shown in the drawings, the roll or coil is of a cylindrical or truncated cone shape and is provided with additional coupling elements. which extend laterally outwardly from the opposite ends of the roll or coil. The wire 12 of such an apparatus 10a is formed to be sufficiently flexible or superelastic in the temperature range in which the apparatus 10a is used (i.e., at room temperature and body temperature) to allow the apparatus 10a to be compressed radially initially (and longitudinally elongated concurrently) to a compact configuration, of relatively small diameter, which can be inserted into the lumen of a delivery catheter. The delivery catheter is then advanced through the desired anatomical passageway (eg, BVi, or BV2 blood vessels such that a catheter opening is located within the region between the openings of the side wall in the anatomical passages. adjacent or blood vessels BVi, or BV2. After this, the apparatus 10a is ejected out of the catheter and flexible or elastically resumes its hyperbolic or hourglass configuration, such that the ends of the first diameter Di will couple the walls of each anatomical duct or blood vessels BVi, BV2 and the diameter D2 of the intermediate portion will lie within the space or tunnel of tissue created between the lateral wall of the openings in the adjacent anatomical ducts or blood vessels BVi, BV2. connector 10a shown in Figure 2, the entire apparatus 10a is formed of a roll or coil of coiled wire tightly wound such that each adjacent convolution of the wire 12 is in close juxtaposition or in abutting contact with the adjacent convolution thereof. This provides a roll or hyperbolic coil of substantially continuous construction, as shown in Figure 2. Figure 2 'shows a variant of the first embodiment of the connector apparatus 10a wherein the flexible or superelastic wire 12 is tightly wound at any end so that the multiple adjacent convolutions of the wire are spaced closely or in direct butt contact at either end of the apparatus 10a ', while the intermediate portion of the apparatus D2 comprises a loosely wound, traversed segment 14 comprising a single cord of the wire 12 which extends from the convolutions that make butt contact at one end of the apparatus 10a ', with the convolutions that make butt contact at the other end of the apparatus 10a'.
In the variant shown in Figure 2 '', the apparatus 10a '' comprises segments of the coiled wire coil wound tightly of the generally spiral or truncated cone configuration located at either end, with a tubular sleeve 16 forming the intermediate portion of the apparatus 10a ". This tubular sleeve 16 can be formed of tubular plastic material such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polyethylene (PE), silicone, polyurethane (PU), or polyester. Alternatively, the tubular sleeve 16 may be formed of natural, autologous or xenograft material. The segments of the coiled or truncated cone wire coil located at either end of the apparatus 10a '' may comprise the opposite ends of a roll or coil of wire which extends through the lumen of the tubular sleeve 16, or may comprising two separate non-continuous roll or coil segments, each of which is fixed or mounted to one end of the tubular sleeve 16. The variant of the connecting apparatus 10a '' 'shown in Figure 2' '' comprises a roll or tightly wound helical coil, flexible or superelastic wire 12, which is similar in configuration to that shown in Figure 2, but where two or more adjacent convolutions of the wire 12 in the middle portion of the apparatus 10a "" have they have been welded, adhered or fused together to form a continuous tubular intermediate portion of diameter D2. Such fusion of the adjacent convolutions of the wire 12 forming the intermediate portion of the apparatus 10a '' 'can comprise welded joints 18, or an adhesive or any other suitable melting material, capable of adhering by welding or otherwise fusing the adjacent convolutions 12 wire each other. It will be appreciated that many of the embodiments of the connector apparatus 10 of the present invention may be constructed to be changed to a longitudinally collapsed or longitudinally compressed configuration to compress or longitudinally confine the fabric between the first and second apertures formed in the first and second structures. anatomical or blood vessels BVi, BV2. Figure 2 '' '' shows an example of this concept, as it is applied to a coil or helical coil connector of Figure 2. As shown in Figure 2 '' '', the connector 10a '' '' of roll or helical coil, when in its loose or relaxed position, has a longitudinally compact configuration wherein the first and second ends of the roll or coil are closely spaced. When this embodiment of the connecting apparatus 10a "'' 'is implanted within the first and second openings formed in the first and second anatomical structures or blood vessels BVi, BV2, the opposite ends of the connector apparatus 10a' '' 'will couple the openings in the adjacent anatomical structures or blood vessels BVi, BV2 and will conform to the length of the channel formed between them. In this way, the elastic nature of the roll or coil will tend to push or pull the opposite ends of the roll or coil inward, thereby compressing or longitudinally restricting the tissues which are located between the opposite ends of the roll or coil. It should be noted, however, that the force exerted by the roll or coil is preferably not so great as to cause undesirable tissue necrosis or an undesirable proliferation of tissues which are compressed or longitudinally restricted by this embodiment of the apparatus 10a '' ''. It will be further appreciated that the deviation or change of the connecting apparatus 10a "'' 'to such a longitudinally compact configuration will make it possible for the connecting apparatus 10a" "to be used in the channels or passageways of variable length, whereby the need is eliminated. of providing the manufacture and storage of a variety of such connecting apparatus 10a "" 'having different lengths.
ii. Mesh or Network connectors
Figures 3-3 '' 'show various variants of the tubular mesh connector apparatus 10b having inwardly arched walls (eg, hyperboloidal sidewalls). Figure 3 shows a basic hyperbolic mesh connector apparatus 10b which comprises a tube formed of wire mesh having an "hourglass" or hyperboloid configuration, internally arched. However, it will be appreciated that the wire mesh connectors may alternatively be of cylindrical or truncated cone configuration with additional coupling elements or projections extending laterally outwardly from the opposite ends of such a cylindrical or cone-shaped mesh tube. truncated. This embodiment of the connector apparatus 10b has ends remote from a first diameter Di and a second diameter D2. The diameter D2 of the intermediate portion is smaller than the diameters Di of the ends, whereby the desired hourglass or hyperbolic configuration is provided. The mesh structure of the apparatus 10b is preferably formed of a multiplicity of wire segments 18 which are intertected in the desired mesh structure. The wire segments 18 may be formed of a flexible or superelastic wire material to make the apparatus 10b radically compressible (and longitudinally elongating concurrently) to a reduced diameter capable of being placed within a delivery catheter, and to subsequently allow that the apparatus 10b is elastically self-expanding to its desired hourglass or hyperbolic hourglass configuration of the diameters Dx and D2 after they have been expelled from the restriction catheter or other delivery device. In some applications, the hyperbolic or hourglass configuration of the apparatus 10b will be such that the end portions of the diameter Di will couple the walls of the adjacent anatomical passages or blood vessels BVi, BV2, to retain the device 10b in the desired position between the anatomical passages or blood vessels BVi, BV2. In other embodiments, as shown in Figures 3 ', 3' ', and 3' '', one or more deployable coupling elements 20 can be formed at one or both ends of the wire mesh tube to facilitate the coupling of the opposite ends of the apparatus 10b to the walls of the connected anatomical passages or blood vessels BVi, BV2. Figure 3 'shows a variant of the apparatus 10b' having coupling elements 20 of the loop or loop type, formed on both ends thereof.
Initially, as shown in Figure 3 ', the coupling elements 20 of the loop or wire type will be deployed in the extended positions in such a way that they extend longitudinally from either end of the wire mesh tube and are parallel or parallel to each other. almost parallel to the longitudinal axis LA of the apparatus 10b '. These coupling elements 20 can be formed of flexible or elastic material to be self-folding (Figure 3 '') or can be formed of malleable material or that can be folded to be deployed under pressure (Figure 3 '' '). With reference to the particular variant of Figure 3 '', the elastic or self-deployable coupling elements 20, when released from the surrounding restriction of the delivery catheter, will self-extend (i.e., curve outwardly) to their mating positions. desired in which such coupling elements 20 can be generally perpendicular or almost perpendicular to the longitudinal axis LA of the device 10b ". With reference to Figure 3 '' ', in the embodiments where the coupling elements 20 are formed of a malleable or plastically deformable metal or another material which is deformable under pressure, the apparatus 10b' '' will be placed initially within the adjacent openings formed in the first and second anatomical passages or blood vessels BVi, BV2 in such a way that the coupling elements 20 formed at one end of the apparatus 10b '' 'protrude or extend towards the lumen of the first anatomical passage or blood vessel BVi and the coupling elements 20 on the opposite end of the apparatus 10b' '' protrude or extend into the lumen of the second anatomical passage or blood vessel BV2. A pressure apparatus, such as the double ball catheter 24 shown in Figure 3 '' ', is then used to exert pressure against the coupling elements 20 to cause the coupling elements to deploy or deform outwardly to the positions which are substantially perpendicular or almost perpendicular to the longitudinal axis LA of the apparatus 10b '' ', or in such a way that the coupling elements will be interleaved or hooked into the adjacent tissue of the anatomical structure. In this way, the coupling elements 20 can make butt contact against or enter the adjacent walls of the first and second passages or blood vessels BVi, or BV2. A type of double-lumen catheter 24 usable for this purpose comprises an elongated folding catheter 26 having an hourglass-shaped or singular-shaped balloon or the combination of a first balloon 28 and a second balloon 30 formed in a Place spaced away on it, as shown. The first balloon 28 and the second balloon 30 are spaced apart or separated by a distance which is equal to, or is based on a predetermined relationship with respect to, the length of the apparatus 10b '' 'such that the first balloon 28 can be placed inside and adjacent to the coupling elements 20 extended longitudinally on one end of the apparatus 10b "'' and the second balloon 30 can be placed in and adjacent to the coupling elements 20 extended longitudinally on the other end of the apparatus 10b '' '. After this, the first and second balloons 28, 30 are inflated causing them to exert a pressure against the coupling elements 20 on both ends of the apparatus 10b '' ', leading to the desired folding or unfolding of the coupling elements 20 to their coupling positions where they are generally in juxtaposition with, or interspersed with, the wall (s) of the anatomical structure on either side of the channel. After this, the first balloon 28 and the second balloon 30 are deflated and the catheter 26 is removed, leaving the connector apparatus 10b '' 'in its installed location and implanted between the first and second passages or blood vessels BVi, BV2.
iii. Tubular connectors
Figures 4-4 '' 'show several variants of a tubular connector apparatus 10c-10c' '' which generally comprises a segment of a tubular element elastic, compressible or collapsible radially having side walls in the shape of an "hourglass" "or hyperboloid, internally arched, having opposite ends of a first diameter Di and an intermediate portion of a second diameter D2. It will be appreciated, however, that the tube may alternatively be cylindrical or truncated cone shaped with additional coupling elements which extend laterally outwardly from either end of the tube, which may not require expansion for placement. Specifically, Figure 4 shows a connector apparatus 10c which comprises a tubular element 36 with hyperbolic or hourglass shape, which is movable within lateral openings formed in two adjacent anatomical passages (eg, blood vessels BVi, BV2 ) such that one end of the tubular element 36 having the diameter Di will couple the lumenal surface of one of the passages or blood vessels BVi and the other end of the tubular element 36 also of diameter Di will couple the lumenal surface of the other passageway or vessel blood BV2. The elongated or tapering diameters of the ends of the tubular elements 36 which therefore serve to couple the anatomical passages or blood vessels BVi, BV2 without the need for additional projections, projections or other coupling elements on either end of the tubular element 36 Figure 4 'shows the hyperbolic tubular element 36 of Figure 4 with optional coupling elements 20 formed on both ends thereof. These coupling elements 20 may comprise projections, lugs, or, as shown, extendable wire loops. These coupling elements 20 are initially positioned in such a way that they extend longitudinally from either end of the hyperbolic tubular element 36 and are parallel or almost parallel to the longitudinal axis LA of the tubular element 36. After the tubular element 36 has been placed in its desired position between the two anatomical passages or blood vessels BVi, BV2, the coupling elements 20 is caused to extend outwards in such a way that they become perpendicular or almost perpendicular to the longitudinal axis LA of the tubular element 36, as it is shown in Figures 4 '' and 4 '' ''. The coupling elements 20 may be formed of a spring material or having a shape, flexible, superelastic memory, to be self-deployable (Figure 4 '') or may be formed of a plastically deformable or bendable material , so that it is deployable under pressure (Figure 4"'). With reference to Figure 4' ', a self-deploying modality of the apparatus 10c comprises coupling elements 20 which, when they have enhancements of the surrounding restriction of a delivery catheter or of another supply apparatus, they will self-deploy to their outwardly deployed positions, where they are generally perpendicular or almost perpendicular to the longitudinal axis LA of the apparatus 10c ". With reference to Figure 4 '' ', there is shown a of the apparatus 10c '' 'wherein the coupling elements 20 are deployable under pressure.This embodiment of the apparatus 10c' '' is initially positioned in such a way that the elements Coupling elements 20 on one end of the apparatus 10c '' 'extend towards the lumen of an anatomical passage or blood vessel BVX, and the coupling elements 20 on the other end of the apparatus 10c' '' extend towards the lumen of the second. Anatomical catheter or blood vessel BV2. A pressurizing apparatus, such as the balloon catheter 26 described above, having first and second balloons 28, 30, is then used to exert pressure on the coupling elements 20 to cause the coupling elements to move from their positions. longitudinally extended (Figure 4 ') to their outwardly extended positions (ie, in the operative positions where they are generally perpendicular or almost perpendicular to the longitudinal axis LA of the apparatus 10c '' '). After this, the balloons 28, 30 of the balloon catheter 26 or other pressure-exerting elements of any suitable pressure-exerting tool are deflated or otherwise decoupled and the catheter 26 is removed, whereby it is left to the apparatus 10c in its desired position between the first and second anatomical passages or blood vessels BVi, BV2, with the coupling elements 20 in direct butt contact with the lumen surfaces of the respective first and second passages or blood vessels BVi, BV2.
iv. Cylindrical Connectors with a Coupling Surface
Figures 5-5 '' show several variants of a cylindrical connector apparatus 10b of the present invention. This cylindrical connector apparatus 10b generally comprises a cylindrical tubular intermediate portion 38 of substantially constant diameter, in combination with one or more coupling elements 20 formed on either end thereof. The coupling elements 20 may comprise deployable wire loops as shown in the drawings, or any other suitable type of projection, lip, lug or other element capable of embedding against the lumenal wall of an anatomical catheter or blood vessel BVX, BV2 for preventing sliding or longitudinal movement of the tubular intermediate portion in at least one direction. In this way, the formation and deployment of such a coupling element on either end of the tubular intermediate portion 38 will anchor and retain the tubular intermediate portion 38 in its desired implant position between the openings formed in the adjacent passages of the blood vessels BVi and BV2. The tubular intermediate portion 38 of the apparatus 10 may comprise a plastic, elastic, woven dacron tube, or any other suitable material which is foldable to a small diameter so that it is initially packaged within the lumen of a delivery catheter, and which it is radially expandable or subsequently deployable to a desired diameter D such that blood or other body fluid can flow through the cylindrical tubular element 38 from an anatomical passageway or blood vessel BVi into another anatomical passageway or blood vessel BV2.
Alternatively, it will be appreciated that the tubular intermediate portion 38 may be a rigid or semi-rigid tube formed of metal, carbon or alloy, which is generally non-radially expandable, but which is provided with additional coupling elements which may be deployed or extended from the opposite ends of the tubular intermediate portion 38 to be coupled or interspersed within the adjacent tissue of the anatomical structure. These intermediate tubular portions 38 rigid or semi-rigid may be of any configuration in a suitable manner, including a cylindrical, truncated or hyperbolic cone shape (eg, hourglass). The coupling elements 20 are initially initially positioned at positions where they are extended longitudinally from either end of the cylindrical tubular intermediate portion 38, generally parallel or almost parallel to the longitudinal axis LA of the apparatus 10D as shown in Figure 5. The coupling elements 20 can be formed of a flexible, superelastic spring or shape memory material, so that it "is self-folding (Figure 5) or can be formed of plastically deformable or bendable material, so that it is deployable under pressure (Figure 5 '').
With reference to Figure 5 ', a self-deploying modality of the device 10 comprises coupling elements 20 which, when raised or raised from the surrounding restriction of the delivery catheter or other delivery apparatus, will self-deploy to their outwardly deployed position. wherein they are generally perpendicular or almost perpendicular to the longitudinal axis LA of the apparatus 10b '. With reference to Figure 5 '', in the embodiments of the apparatus 10b '' wherein the coupling elements 20 are self-deployable. This embodiment of the apparatus 10b "is initially positioned in such a way that the coupling elements 20 on one end of the apparatus 10b" extend towards the lumen of an anatomical passageway or blood vessel BVi and the coupling elements 20 on the other end. of the apparatus 10b '' extend towards the lumen of the second anatomical passageway or blood vessel BV2. An apparatus that puts pressure, such as the balloon catheter 26 described above having first and second balloons 28, 30, is then used to exert pressure on the coupling elements 20 to cause the coupling elements to move from their longitudinally extended positions (Figure 5) to their outward (ie, operative) extended positions where they are generally perpendicular or almost perpendicular to the longitudinal axis LA of the apparatus 10d "(Figure 5"). After this, the balloons 28, 30 of the balloon catheter 26 or other elements that exert pressure from any tool that exerts adequate pressure, are deflated or otherwise decoupled and the catheter 26 is removed, whereby it leaves the apparatus 10d '. 'in its desired position between the first and second anatomical passages or blood vessels BVX, BV2 with the coupling elements 20 in direct butt contact with the first and second passages or blood vessels BVi, BV2.
v. Rivet Type Connector Device
Figures 6-6 '' show several variants of the rivet type connector apparatus which comprises a first tubular element 40 having a first coupling projection 44 formed thereon and a second tubular member 42 having a second coupling projection 46 formed on it. The first and second tubular elements 40, 42 are connectable with each other in such a way that the lumens of the tubular elements 40, 42 are in direct alignment whereby a singular lumen 41 is formed through the center of the apparatus 10e, 10e ', 10e ''.
Various friction coupling or snap fastening systems can be used to securely connect the first and second tubular elements 40, 42 to each other, and examples of such friction or snap-fit systems are shown in FIGS. drawings of Figures 6, 6 'and 6". With specific reference to Figure 6, an annular groove 48 is provided on the outer surface of the first tubular member 40 and a corresponding raised shoulder 50 on the outer surface of the second tubular member 42 The raised shoulder 50 is dimensioned and configured to close under pressure and settle within the notch 48 so that the first tubular member 40 is advanced into the second tubular member 42. When the annular shoulder 50 is seated within the corresponding notch 48, the respective engagement projections 44, 46 will be maintained in fixed spaced relation to each other such that the distance re the projections 44, 46 will lead to the engagement of the projections with the respective lumenal walls of the anatomical passages or blood vessels BVi, BV2 which are proposed to be connected by the device IOe. Figure 6 'shows another connecting device 10 comprising a first tubular element 40' and a second tubular element 42 '. Coupling projections 44 ', 46' are formed around the outer ends of the first and second tubular elements 40 ', 42', respectively. When the unsprung end of the first tubular member 40 'is advanced towards the end without protrusions of the second tubular member 42', the respective lumens of the two tubular elements 40 ', 42' will be in direct alignment to form a single continuous lumen 41 through the center of the apparatus 10e '. The outer surface of the first tubular element 40 is tapering inward toward the end without protrusions in such a way that when it is advanced into the second tubular member 42 'the outer surface of the first tubular member 40' will be pressed against and will frictionally couple the inner surface of the second tubular member 42 ', whereby the first and second tubular elements 40', 42 'are retained in a connected, fixed relation to each other, such that the coupling projections , 44 ', 46' are held in spaced apart relation such that the distance between them will cause the projections 44 ', 46' to be in abut contact with the respective lumenal surfaces of the first and second passages or blood vessels BVi , BV2.
saw. Elastomeric Connector Device
Figures Ia-Id 'show examples of the connecting apparatus 10, 10 of the present invention, formed of elastomeric materials such as a flexible elastomeric polymer (eg, polyurethane, silicone, etc.). In particular, Figures 7a, 7a 'show an embodiment of a connector apparatus 10 comprising a cylindrical tube 60, elastomeric, having a hollow lumen 62 extending longitudinally therethrough and four coupling elements of the nature of lugs. , formed on the opposite ends of the tube 60 and extending towards it thereof in directions which are substantially perpendicular to the longitudinal axis LA of the tube 60. FIGS. 7b7b 'show another embodiment of a connector apparatus 10 which comprises an ovoid-shaped tube element 70 formed of an elastomeric material and coupling elements 74 substantially rectangular in nature with the projections formed on either end thereof. The coupling elements 74 extend in directions which are parallel to the longitudinal axis of the oval lumen 72 of the ovoid-shaped tubular element 70, as shown. The provision of the ovoid-shaped tubular element 70 having the ovoid lumen 72, and the directional orientation and corresponding configuration of the coupling elements 74 will make it possible for this modality of the connecting device 10i to be used in the anatomical blood vessels or passageways of diameter relatively small, with openings which are elongated or ovoid to allow a greater amount of body fluid to flow through the openings than would be possible if the openings were of a circular configuration. This is due to the fact that the maximum diameter of any circular opening formed in the side wall of a passageway or blood vessel BVi, BV2 can not exceed the diameter of the passage or blood vessel BVi, BV2, while the elongated or shaped openings of ovoid may have a width which is equal to or slightly less than the diameter of the passageway or blood vessel BVX, BV2 and a length which is larger than the diameter of such passage or blood vessel BVi, BV2. This tubular element 70 can also incorporate any suitable reinforcing material, such as wire. This non-circular or ovoid-shaped configuration of the tubular member 70 and its lumen 72 can be incorporated in any of the embodiments of the invention described herein, and is not necessarily limited to the particular elastomeric embodiment shown in Figures 7b, 7b '.
In each of these elastomeric embodiments shown in Figures 7a, 7a ', 7b, 7b', the material of such apparatus 10, 10 is formed of sufficiently elastic and compressible material to be initially packed in the lumen of a delivery catheter , and is sufficiently resilient such that when the device 10 is ejected or otherwise passed out of the delivery catheter, the absence of restriction on the device 10 will allow the device to assume its fully expanded and operational configuration, as shown in the Figures. When in such an operational configuration and fully expanded, butt contact elements 64 or 74 will butt against the lumenal surfaces of the passages or blood vessels BVi, BV2, in the regions immediately surrounding the openings formed therein, and the tubular elements 60, 70 of the apparatus 10, 10 will extend between the passages or blood vessels BVX, BV2, whereby they will form a passage or passage between the openings formed in the passages or blood vessels BVi, BV2.
vii. Wire Connector Device With Optional Coverage
Figures 7c-7d 'show examples of wire connecting elements with optional covers formed thereon. These covers can cover all or any portion of the device. For example, such a cover can be formed on the connecting portion or intermediate portion of the apparatus to form a sleeve or cover which covers the passageway, while the coupling portions (eg, extensible coupling elements) of the apparatus can remain devoid of such cover. Such covers can be formed of any suitable material including, but not limited to, elastomeric material, fabrics (eg, woven polyester) or natural materials such as an autologous or xenograft material. With specific reference to the embodiment shown in Figure 7c, two generally-spaced U-shaped wire elements 80 are provided, which are interleaved or partially fused with an elastomeric tubular element 82 having a hollow lumen 84 extending longitudinally to through it. Optionally, the portions of the wire elements 80 which protrude out of the elastomeric tubular element 82 may also be covered, with the elastomeric material 86. In this manner, the wire portions 80 (with or without an elastomeric cover 86) which protruding externally from the elastomeric tubular element 82, they can serve to abut against and engage the lumenal surfaces of the passages or blood vessels BVi, BV2, immediately adjacent to the openings in the side wall formed therein, while the element Elastomeric tubular 82 will form a transverse conduit between the passages or blood vessels BVi, BV2. In this way, the protruding portions of the wire elements 80 with or without their elastomeric covers 86 will serve to anchor and retain the device lOj in its desired position between the passages or blood vessels BVi, BV2, in such a way that the body fluid can passing through the lumen 84 of the tubular element 82, from one of the passages or blood vessels BVi, to the other passageway or blood vessel BV2. Figures 7d-7d 'show another embodiment of a connector apparatus 10k which comprises a continuous segment of wire that is shaped in a configuration having four generally U-shaped projections 92 extending laterally outwardly therefrom in the same direction. opposite directions.
This lOk device can be used as a connecting device in and of itself, without any elastomeric coverage, such that the U-shaped projection 92 can be placed in abutting contact with the lumenal surfaces of the passages or blood vessels BVi , Adjacent BV2, whereby the openings formed in the passageways or blood vessels are fixed with tweezers or retained., BV2 in alignment with each other, and the desired interconnection of the passages or blood vessels BVi, BV2 is established. Figure 7d 'shows an optional elastomeric tubular element 94 having the central portion of the wire element formed therein, such that the U-shaped projections 92 extend laterally outward and away from the elastomeric tubular element 94. this way, the elastomeric tubular element is provided with a hollow lumen 96 extending longitudinally therefrom and, when the U-shaped projections 92 are in abutting contact with the lumenal surfaces of the passages or blood vessels BVi, BV2 , the elastomeric tubular element 94 will form a discrete conduit or passage through which the body fluid can pass through the lumen 96 of the tubular element 94 from a passage or blood vessel BVX to the other passage or blood vessel BV2. Optionally, the elastomeric material may also extend over and cover the U-shaped projections 92, as denoted by the dotted lines in Figure 7b '.
viii. Sine Wire Wire Connector
Figures 8-8a show a connector apparatus 101 which is formed of a wire element 100 which has been formed or bent into multiple sinusoidal waves or convolutions, some of such sinusoidal waves or convolutions are of a first size 102 and others of such sinusoidal waves or convolutions are of a second size 104. Preferably, the smaller sine waves or convolutions 102 are formed in pairs or pairs, with the larger sinusoidal waves or convolutions 104 which are also formed in pairs or pairs, which are placed alternately with the pairs or pairs of the smaller sine waves or convolutions 102. In this way, when the opposite ends of the wire element 100 are fused or coupled together by means of a sleeve element 101, the smaller sinusoidal waves or convolutions 102 will define a hollow passageway 106 and the other larger sine waves or convolutions 104 may be bent laterally outwardly from the center of passageway 106 to abut against and engage the respective lumenal surfaces of the anatomical passages or blood vessels BVi, BV2, as shown in Figure 8a. In this way, the sinusoidal wire connecting apparatus 101 shown in Figures 8, 8a serves to retain the first and second blood vessels BVX, BV2 in connection with each other in such a way that the openings of the side wall formed in such first and second second blood vessels BVi, BV2 will be maintained in direct alignment with each other, whereby body fluid is allowed to pass through passageway 106 of the connecting apparatus 101 from the lumen of a BVX blood vessel to the lumen of the other blood vessel BV2. It will be appreciated that a cover formed of any suitable material (e.g., elastomeric, woven, or natural graft material, etc.) may be formed on all or part of the device. For example, a tubular cover may be mounted on the intermediate portion formed by the smaller sine waves or convolutions 102 and the basal portions of the larger sinusoidal waves or convolutions 104, and such cover may optionally extend outwardly over all of the laterally bent portions of the larger sinusoidal waves or convolutions 104, according to the invention as described here above with reference to Figures 7c and 7d '.
ix. Triple Coil Type Connector Device
Figure 9 shows a roll-on or triple-coil type lOm connecting apparatus of the present invention, comprising a first roll or coil portion 114a, a second roll or coil portion 114b and a third roll or coil portion 114c. The apparatus 10 is formed of a continuous wire element 110 which has been wound helically to form a roll or coil wherein the adjacent convolutions of the coil are in direct abutting contact with each other, or are spaced closely from each other. The first segment 114a of the roll or coil has a first longitudinal axis LAi. The segment 114b of the coil has a second longitudinal axis LA2 which may be perpendicular to the first longitudinal axis LAi of the first segment 114a of the roll or coil. The third segment 114c of the roll or coil has a third longitudinal axis La3 which can be parallel to the first longitudinal axis LAX of the first segment 114a of the roll or coil and perpendicular to the second longitudinal axis LA2 of the first segment 114b of the roll or coil.
The length 1 of the second segment 114b of the coil may vary depending on the desired distance between the first and second passages or blood vessels BVi, BV2. The wire element 110 may be formed of any suitable material such as stainless steel, superelastic nickel-titanium alloy, etc. The apparatus 10m is preferably sufficiently foldable and resilient in such a way that the three segments 114a, 114b, 114c of the roll or coil may be placed in direct alignment with each other about a common longitudinal axis and compressed radially (and concurrently elongated) so that it can be placed within the lumen of a delivery catheter. For most intravascular applications, it will be desirable to compress the complete IOm device to a compact configuration which may be mounted in or on a delivery catheter of the type referred to in a more detailed manner hereinafter. After this, the delivery catheter can be advanced through the second blood vessel BV2, through the opening formed between the second blood vessel BV2 and the first blood vessel BVi, and into the lumen of the first blood vessel BVi. After this, the third segment 114c of the roll or coil will be ejected out of the delivery catheter and will be allowed to assume its radially expanded operative configuration, as shown in Figure 9. After this, the delivery catheter is retracted to a position within or adjacent the opening between the first blood vessel BVi and the second blood vessel BV2, and the second segment 114b of the roll or coil will be ejected or advanced outside the delivery catheter and allowed to radially expand to its configuration and operative attitude, expanded, around the second longitudinal axis LA2 as shown in Figure 9. After this, the delivery catheter is further retracted into the lumen of the second blood vessel BV2 and the first segment 114a of the roll or coil is expelled or advanced outside the delivery catheter and will be allowed to expand to its operational, expanded configuration, as shown FIG. 9. In this manner, the first and third segments 114a, 114c of the roll or coil will settle against and frictionally couple the lumenal surfaces of the first and second blood vessels BVi, BV2, respectively, and the second segment. 114b of the roll or coil will pass through any space which exists between the first and second blood vessels BVX, BV2. It will be appreciated that a tubular enclosure or enclosure may be formed on the inner and / or outer surfaces of any and / or all of the roll or coil elements 114a, 114b, 114c to provide a flow passage which is impermeable to fluid, or to improve the biocompatibility of the lOm device.
x. Tubular Type Connector Device with Projections
Figures 10-10b show a tubing type lOn connecting device with projections of the present invention. It will be appreciated that, in addition to the specific protrusion configurations shown in the drawings, such protrusions may be formed in many different configurations and designs and / or may include notches, geometries and configurational attributes designed to improve the ability of the connector apparatus to resist contractions. / longitudinal expansions and orienting / rotating movements of the surrounding tissue. The embodiment lOn shown in Figure 10 comprises a pipe segment which has been provided with notches and formed in such a way that the arched or semi-cylindrical projections 120 extend laterally outwardly from opposite sides of either end of a tubular intermediate portion. or cylindrical 122. When implanted between two blood vessels, as illustrated in Figure 10, the arched or semi-cylindrical projections 120 will butt against the lumenal surfaces of the blood vessels and will approximate the semi-cylindrical or arcuate shape of the surface of the adjacent lumenal blood vessel. The tubular or cylindrical intermediate portion 22 forms a discrete tubular conduit which extends between the openings formed in the adjacent blood vessels, whereby a conduit substantially fluid-tight through which blood or other body fluid can pass. Figures 10-10b illustrate a preferred method of manufacturing this tube type connector apparatus with lOn projections. With reference to Figure 10a, a cylindrical pipe segment formed of an elastic metal, flexible plastic, shape memory alloy or other suitable material, is precut such that two (2) longitudinal notches 124 (e.g., notches) rectangular) are formed at each end of the tube, in locations directly opposite each other, as shown. After this, two transverse grooves 126 (for example, arched or wedge-shaped notches) are formed on either side of the tube such that the center of such transverse groove 126 is approximately 90 ° from the centers of the grooves adjacent longitudinals 124 formed on each end of the tube. After this, the protruding end portions of the notched tube are deformed or bent outwards, as indicated by the arrows on Figure 10a. This leads to the formation of the connector apparatus 10 shown in Figure 10 which comprises the tubular intermediate portion 122 having the arched or semi-cylindrical protrusions 120 which extend laterally outward from each of the ends of the tubular intermediate portion 122.
xi. Cylindrical Connectors that have Grooved External Surfaces
Figs lla-llc show three embodiments of the external splined cylindrical connectors 10o, lOp, lOq of the present invention. The connector 10o shown in Figure la comprises a cylindrical tubular body 130 formed of a rolled sheet of flexible metal or plastic having overlapping ends 132 such that the rolled cylindrical body can be compressed radially to a radially compact diameter, and subsequently elastically returned to a radially expanded diameter as shown in FIG. The projections or cylindrical channels 134 are formed around any end of the rolled tube 130, as shown. In this way, the apparatus 10 can be retained in its radially compact state within an introducer or catheter and delivered to a passage formed between two anatomical structures, where it is allowed to expand radially to its operative configuration. Such radial expansion will cause the projection 134 at one end of the cylindrical roll body 130 to abut against and engage the lumenal surface of a first blood vessel or anatomical structure, which surrounds a first opening formed in this blood vessel or anatomical structure. Similarly, the projection 134b on the opposite end of the rolled tubular body 130 will abut against and engage the lumenal surface surrounding an opening formed in a second blood vessel or other anatomical structure. Figure 11b shows another corrugated connector apparatus lOp which also comprises a cylindrical body portion 136 wound, formed and configured in the same manner as that shown in Figure Ia. In this IOP apparatus, a plurality of annular protrusions or channels 138 are formed around the outer surface of the wound cylindrical body 136. When this IOP apparatus is delivered into a passageway between two blood vessels or other anatomical structures and is allowed to expand, the projections or channels 138 on the outer surface of the rolled cylindrical body will sandwich or interconnect an interstitial tissue which surrounds the cylindrical body 136, thereby retaining the IOP apparatus in its desired position between the openings formed in the blood vessels or adjacent anatomical structures. It will be appreciated that this embodiment of the lOp apparatus will be particularly useful in applications where firm interstitial tissue surrounds the passageway which extends between openings formed in adjacent blood vessels or anatomical structures. Actually, this IOP apparatus is free of any projections, projections or surfaces which will butt against or engage the lumenal surfaces of adjacent blood vessels or anatomical structures, and is supported instead of in engagement with the projections or channels. of the interstitial tissue to prevent the IOP device from disengaging or moving longitudinally following the implant. Figure 11c shows another example of a cylindrical cylindrical connector apparatus lOg comprising a continuous cylindrical tubular body 140 having a projection or helical channel 142 formed around the external surface thereof. The continuous cylindrical body 140 differs from the rolled cylindrical bodies of the embodiments 10o, lOp shown in Figures Ia and llb in that it has no overlapping ends and can not be compressed radially in a "rolled or wrapped" state. Instead, the cylindrical body 140 of this apparatus 10 is of a continuous cylindrical structure and is formed of an elastic or collapsible material that will make it possible for the apparatus 10 to be placed in a radially compact or reduced condition for delivery to a passageway. formed between the openings and adjacent blood vessels or anatomical structures. After the tubular body 140 has been supplied and expanded to its operational configuration as shown in Figure 11c, the helical projection or channel 142 will engage the interstitial tissue surrounding the passageway. As in the embodiment shown in Figure 11b, this lOg apparatus will be usable particularly in applications where the passage formed between the blood vessels or other anatomical structures has a surrounding interstitial tissue within which the projection or helical channel 142 can be fitted.
xii. Possible Modifications of Modalities to Accommodate Diagonal Passages or Connections between Different Anatomical Structures of Blood Vessels
Figures 12 and 13 are proposed to show the modifications and alternative applications which may be applicable to the connector apparatus shown in Figures 1-11. Figure 12 is illustrative of the concept forming the ends of each connecting apparatus 10 such that the ends are not perpendicular with respect to the longitudinal axis LA of the apparatus 10. Such angular cutting of the ends of the connecting apparatus 10 will be applicable when the apparatus connector 10 is placed within a diagonal or curved passage formed between the openings which are not directly opposite each other on the adjacent anatomical structures or blood vessels BVi, BV2. This aspect of the invention will be particularly applicable in certain artery bypass procedures, such as those described in US Patent Application Serial Nos. 08 / 730,327 and 08 / 730,496, when it is desired to form passageways for flow. of curved or diagonal blood, to minimize turbulence and to promote the flow of substantially laminar blood through the passageway and into the bypass vessel. Figure 13 shows a connector apparatus 10, which has the configuration of the specific apparatus lOk shown in Figure 7d, placed within a transmyocardial passage formed between a coronary blood vessel.
CBV and the left ventricle LV of the heart. In this way, Figure 13 serves as an example of an application where any or all of the connecting apparatuses 10 of the present invention can be used to form a connection between the different anatomical structures of two blood vessels.
(ie, a coronary blood vessel and a heart chamber).
xiii. Possible Modification of the Modalities to Adapt or Form the Different Length Passages
It will be appreciated by those skilled in the art that the length or distance between the first and second anatomical structures can vary considerably. Accordingly, for embodiments of the connector apparatus 10 which is of a fixed length, it may be desirable to manufacture or provide such a connector apparatus in a variety of lengths and sizes to allow the operator to select the appropriate length or size for use in the present request. Alternatively, many, if not all, of the embodiments of the present invention can be constructed in such a way that the connecting portion of the connector apparatus 10 is elastic, adjustable, telescopic, extensible, of suitable configuration or otherwise adjustable to accommodate or conform to the passageways of different length.
xiv. Supply and Implantation of the Connector Device
It should be generally understood that the connector can be supplied by any number of possible delivery mechanisms that include but are not limited to: 1. Supply mechanisms which trap the connector initially within an internal tubular element and an element external tubular wherein the movement of the first element relative to the other allows the connector to be exposed and deployed first partially to allow the first set of coupling elements to come into contact with the first lumen and then be fully deployed to allowing the second set of coupling elements to come into contact with the second lumen. Connectors which are mounted on a ball, covered or not covered by a temporary lining, and then deployed with help or forcedly directed by the ball to its engaging position. Connectors mounted between two balloons, covered or not covered initially by a liner, where the balloons act mainly to bring the coupling elements in contact with the appropriate lumens; however, the two balloons can act additionally to dilate and further deploy the connector within the channel. Two-piece connectors, such as the rivet device shown in Figure 6, can be deployable by means of two elements mounted on a central core, capable of moving with each other in such a way that the resultant force acts to couple the internal part of the two rivet components, fixing them appropriately. Supply mechanisms which retain the connector in a compressed state within a liner and deploy the connector by means of the relative movement of an internal push rod mechanism, enabling it to deploy in a first partially expanded state, and then to a state expanded completely. 6. Supply of connectors which can be rotatably inserted into the tissue, expanding them when they are advanced towards their position, and then uncoupled, allowing the connector to remain anchored within the channel that was partially improved by the delivery mechanism. 7. Supply mechanisms which use some form of thermal, electrical, fluid or chemical means to induce a conformational change in the connector during proper placement in the channel. Examples of suitable delivery catheters for implanting the connector apparatus 10 of the present invention are shown in Figures 14a-14d. Figure 14a shows a delivery catheter 100a of the removable liner type, comprising an elongate internal member 102 having a connector apparatus 10 of the present invention mounted thereon, and an outer retractable liner 104 surrounding it. The connector apparatus 10 in this embodiment is preferably self-expanding or is formed of a shape memory material which will expand radially when heated to body temperature. When the liner 104 is completely advanced over the connector apparatus 10, the liner will radially restrain and retain the connector apparatus 10 in the radially desired, compact configuration. After the catheter 100a has been advanced to the desired location, the liner 104 can then be retracted (or alternatively the internal element 102 can be advanced) whereby the surrounding restriction of the connector apparatus 10 is removed in such a way that the Connector apparatus 10 can expand radially and become implanted in the desired location. Figure 14b shows a balloon delivery catheter 100b comprising a tubular catheter body 106 and an elongate member 108 having an inflatable balloon 110 formed thereon. The connector apparatus 10 is initially mounted on the deflated balloon 110 with the connector apparatus 10 in its radially compact configuration. After the catheter 100b has been advanced to the desired implant site, the catheter 106 is withdrawn or withdrawn (or the internal member 108 is advanced) and the balloon is inflated to radially expand the connector apparatus 10 and cause the apparatus Connector becomes implanted in your desired implant site. Figure 14c shows a push rod type delivery catheter 100c comprising an outer tubular liner 112 and a push rod 114 that can be advanced. The connector apparatus 10 is initially placed in the lumen of the liner 112 of the catheter, forward of the end remote from the push rod 114, with the connector apparatus 10 which is in its radially compact configuration. After the catheter 100c has been advanced to the desired implant site, the catheter 112 can be retracted (or the push rod 114 can be advanced) to eject the connector apparatus 10 away from the far end of the catheter. In this way, the connecting apparatus 10 is enhanced or released from any surrounding restriction and is allowed to radially expand and become implanted at the desired implant site. It will be appreciated that this embodiment is particularly suitable for the self-expanding embodiments of the connector apparatus 10 or those formed of the shape memory material which will expand during heating to body temperature. A more detailed description of this type of push rod of the delivery catheter is described in the original application Serial No. 08/730, 327, filed October 11, 1996. Figure 14d shows a lOOd supply of the sliding liner type. This device comprises an internal element 120 on which the connector apparatus 10 is mounted in its radially compact configuration.
The proximal and remote liners 122a, 122b are initially withdrawn together in such a way that the remote end of the proximal lining member 122a is in abutting contact with the proximal end of the remote liner element 122b, thereby covering and providing an enclosure or restriction around the radially folded connector apparatus 10. After the catheter 100b has been advanced to the desired implant site, one or both of the proximal and remote liner elements 122a, 122b is / are moved away from each other to expose the radially compact connector apparatus 10, as shown in Figure 14b. In embodiments where the connector apparatus 10 is self-expanding or formed from the shape memory material, which will expand during heating to body temperature, such opening of the slide liners 122a 122b will allow the connector apparatus 10 to be expand and become implanted in your desired implant site. In other embodiments where the connector apparatus 10 is formed of a plastically deformable material, the radial expansion element such as an inflatable balloon will be mounted on the internal member 120 below the radially compact connector apparatus 10. Such a radial expansion or balloon can then be expanded radially (eg, inflated) so that it expands radially and elastically deforms the connector apparatus 10, when desired. Figure 14e shows a rotary delivery catheter lOOe which comprises an elongate member 130 which is itself rotatable, or which is provided with a remote rotating portion. The connector apparatus 10 is mounted on the remote portion of the elongate element 130, as shown. After the elongated element 130 has been advanced to the desired implant site, the elongate member 130 or the remote portion thereof is rotated, and the elongate member 130 is further advanced to rotationally urge and advance the connector apparatus 10 toward the desired implant site. It will be appreciated that this embodiment is particularly usable for the connector apparatus 10 which is not radially expandable, and / or for those which have helical or spiral channels on the external surface thereof (eg, Figure 11c) and / or for those having a leading edge which is sharpened or otherwise adapted to cut the tissue, to perforate and form or enlarge the passageway when the connecting apparatus is advanced. These additional connector delivery catheters shown in Figures 14a-14e are examples of the types of delivery catheter devices which may be used, in addition to the double balloon catheter shown in Figures 3 '' ', 4' '' and 5", and described in greater detail here above.
xv. Connector Apparatus Which Includes Connecting Portions for Tissue Puncture in such a way that Connection Portions can Radiate Out of the Flow Passage for Fluid
Figures 15a-15a 'show a modified rivet type connector apparatus 10e' '' of the type previously described and claimed in United States Patent Application No. 08 / 730,327. This connector apparatus 10e '' 'comprises first and second annular coupling elements 600, 602, and a plurality of connecting elements 604 which extend from the first coupling member 600 and which are adapted to be coupled and connected to the opening receiving 606 formed in the second coupling element 602. As shown in Figure 9a and 9a ', the connecting element 604 may be able to penetrate through the tissue, and may be positioned such that it will pass through. of the walls of the first and second blood vessels BVi, BV2 and through any intervening interstitial tissue in such a way that the connecting elements 604 will be deposited outside the previously formed channel or passageway, and out of the openings formed in the respective first and second blood vessels BVi, BV2. These drawings illustrate that the connecting portion of the connecting apparatus 10 does not need to extend through or reside within the passageway for fluid flow, but may actually protrude through the intervening tissue and settle out of the passageway, as shown. These delivery devices are generally capable of being advanced over a guidewire into the channel and can help passively or actively in the proper deployment of the connector. It should further be understood that various radiopaque markers or markers for imaging can be placed in important locations on the delivery mechanism to allow proper placement or verification of placement during deployment. In addition, it is also possible that various recapture mechanisms such as thread (s), hook (s) or other capture or securing means may be provided to allow reversible deployment of the connector in the case where it is found to be be inappropriately placed The invention has been described hereinabove with reference to certain currently preferred modalities in a unique manner, and no effort has been made to describe and exhaustively show all possible modalities in which the invention can take a physical form. Actually, numerous alterations, modifications and changes can be made to the modalities described above without departing from the spirit and scope of the invention. For example, specific elements or attributes of a modality may be incorporated in any or all of the other embodiments shown in the drawings, and may be exchanged or recombined in any possible combinations, and all such modifications and combinations of the elements and components of the invention described herein are proposed to be within the scope of the following claims.
It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.
Having described the invention as above, property is claimed as contained in the following
Claims (49)
1. An apparatus for connecting a first opening formed in a first anatomical structure to a second opening formed in a second anatomical structure, said first anatomical structure having an interior space which is defined at least in part by a first internal surface, and the second structure anatomical having an internal space which is defined at least in part by a second internal surface, the apparatus is characterized in that it comprises: a) a first coupling portion which is engageable with the first anatomical structure adjacent to the first opening formed in the same; b) a second coupling portion which is engageable with the second anatomical structure, adjacent to the second opening formed therein; c) a connection portion which connects the first coupling portion and the second coupling portion, the connection portion being configured to retain the first and second openings together.
2. The apparatus according to claim 1, characterized in that the connection portion is a tubular element.
3. The apparatus according to claim 1, characterized in that the connection portion is a wire element.
4. The apparatus according to claim 3, characterized in that the wire element is of a helical configuration.
5. The apparatus according to claim 1, characterized in that the connecting portion comprises a frame which will maintain an open passageway through the surrounding tissue.
6. The apparatus according to claim 1, characterized in that the connecting portion is a mesh tube.
7. The apparatus according to claim 1, characterized in that the first coupling portion is a deployable element which is initially maintained in a non-extended configuration, after being placed adjacent to the first opening formed in the first anatomical structure, is convertible to an extended configuration wherein the first coupling element will couple the inner wall of the first anatomical structure adjacent to the first opening formed therein.
8. The apparatus according to claim 1, characterized in that the second coupling portion is a deployable element that is initially held in a non-extended or unfolded configuration and, after it is placed adjacent to the second opening formed in the second anatomical structure, it is convertible to an extended or unfolded configuration wherein the second coupling element will couple the inner wall of the second anatomical structure adjacent to the second opening formed therein.
9. The apparatus according to claim 7, characterized in that the first coupling element is self-deployable and deformed or elastically returned to its deployed position.
10. The apparatus according to claim 8, characterized in that the second coupling element is self-deployable and deformed or elastically returned to its deployed configuration.
11. The apparatus according to claim 7, characterized in that the first coupling portion is plastically deformable and is initially formed in its undeployed configuration, and is subsequently deformable to its deployed configuration by exerting a pressure against the coupling element.
12. The apparatus according to claim 8, characterized in that the second coupling portion is plastically deformable and is initially formed in its undeployed configuration, and is subsequently deformable to its deployed configuration by exerting a pressure against the coupling element.
13. The apparatus according to claim 1, characterized in that the apparatus is deployable initially in a radially compact configuration, the apparatus is radially expandable immediately up to an operative configuration wherein at least the first and second coupling portions will butt against and will engage the adjacent surfaces of the first and second anatomical structures.
14. The apparatus according to claim 13, characterized in that the apparatus is self-deployable and deformed or elastically returned to its operational configuration.
15. The apparatus according to claim 13, characterized in that the apparatus is plastically deformable and is initially formed in its radially compact configuration, and is subsequently deformable to its operative configuration by exerting a radial pressure on the apparatus.
16. The apparatus according to claim 1, characterized in that it is a roll or hyperboloid helical coil.
17. The apparatus according to claim 16, characterized in that the hyperboloid helical coil or roll is formed of a multiplicity of adjacent convolutions of wire, and wherein at least some of the adjacent convolutions are fused together.
18. The apparatus according to claim 1, characterized in that the first and second coupling portions comprise truncated cone-shaped rolls or coils having internal and external ends, the outer ends of the coils or coils are larger in diameter than the internal ends of them.
19. The apparatus according to claim 18, characterized in that the connection portion of the apparatus comprises a tubular element mounted between and connecting the internal ends of the truncated cone-shaped rolls or coils.
20. The apparatus according to claim 1, characterized in that the apparatus is a tube having side walls arched internally such that the ends of the tube are of a larger diameter than the middle part of the tube, the ends of the tube form by means of of this the first and second coupling portions, and the intermediate portion of the tube forms by this connection portion.
21. The apparatus according to claim 20, characterized in that it further comprises: at least one deployable element formed on each end of the tube.
22. The apparatus according to claim 21, characterized in that at least one deployable coupling element is self-deployable and deformed or elastically returned to an outwardly deployed configuration.
23. The apparatus according to claim 21, characterized in that at least one coupling element is plastically deformable, and initially formed in a non-deployed configuration, but subsequently deformable by exerting a pressure directed outwardly against it.
24. The apparatus according to claim 20, characterized in that the tube is a solid tube.
25. The apparatus according to claim 20, characterized in that the tube is a mesh tube.
26. The apparatus according to claim 20, characterized in that the tube is formed of a material selected from the group of materials consisting of: a roll or coil of helical wire; a roll or coil of helical filament; wire mesh; an alloy with shape memory; plastic; metal; Woven fabric; elastic material; and elastomeric material.
27. The apparatus according to claim 1, characterized in that the apparatus comprises a plastic structure wherein the connecting portion comprises a tube, and wherein one of the first and second portions comprises projections which extend laterally outwards from the ends opposite of the tube.
28. The apparatus according to claim 1, characterized in that the apparatus comprises a wire clamp or clip, wherein the first and second coupling portions comprise wire projections which extend laterally outward from the center of the clamp or clip, and wherein the connecting portion comprises transverse wire segments which extend between the projections.
29. The apparatus according to claim 1, characterized in that the apparatus comprises an elongate element having a series of generally sinusoidal bends formed therein, and first and second ends, the first and second ends of the wire element are joined together to forming a ring, and at least some of the sinusoidal bends or elbows are turned outwardly therefrom to form projections which extend outwardly from the ring, the projections thereby form the first and second coupling portions, and the ring that's why it forms the connection portion.
30. The apparatus according to claim 29, characterized in that the sinusoidal bends or bends include a plurality of first sinusoidal elbows or bends of a first amplitude, and a plurality of second sinusoidal elbows or bends of a second amplitude, the second amplitude being greater than the first amplitude, and second sinusoidal elbows or bends of the second amplitude which are bent or deflected outward to form the projections, and the first sinusoidal elbows or bends of the first amplitude remain without an outward bend to form the ring.
31. The apparatus according to claim 1, characterized in that the apparatus comprises a triple roll or coil connector, comprising: a first coil or coil having a first longitudinal axis, a second coil or helical coil having a second longitudinal axis which is not parallel to the first longitudinal axis, and a third coil or helical coil having a third longitudinal axis, the third longitudinal axis is perpendicular to the second longitudinal axis but spaced away from the first longitudinal axis; the triple roll or coil connector is thus implantable within the body such that the first helical coil is within the internal space of the first anatomical structure, the third coil or coil being within the internal space of the second anatomical structure, and the second roll or helical coil extends between the first and second openings in the first and second anatomical structures.
32. The apparatus according to claim 31, characterized in that the first, second and third roll or coil elements are formed of helically wound wire.
33. The apparatus according to claim 31, characterized in that the first, second and third roll or coil elements are formed of a helically wound filament.
34. The apparatus according to claim 1, characterized in that the connector apparatus is a tube connector with projections wherein the connection portion comprises a tube, and wherein the first and second coupling portions comprise semicylindrically shaped projections which extend laterally out from the opposite ends of the tube.
35. The apparatus according to claim 34, characterized in that the tubular connector with projections is formed by a method comprising the steps of: a) providing a tube having a longitudinal axis, a cylindrical side wall positioned around the longitudinal axis, first and second ends, and a hollow lumen extending longitudinally therethrough; b) forming first and second rectangular notches in opposite locations directly at the first end of the tube, the rectangular notches having side edges which are parallel to the longitudinal axis, and one end of which is perpendicular to the longitudinal axis; c) forming the third and fourth rectangular notches in opposite locations directly at the second end of the tube, the rectangular notches having side edges which are parallel to the longitudinal axis, and one end which is perpendicular to the longitudinal axis; d) forming first and second generally arcuate notches in opposite locations directly on the cylindrical side wall of the tube, in alignment with the ends of the first and second rectangular notches; e) forming third and fourth generally arcuate notches in opposite locations directly on the cylindrical side wall of the tube, in alignment with the ends of the third and fourth rectangular notches; and, f) folding out the remaining cylindrical side walls of the tube adjacent the rectangular notches in such a way that the generally arcuate notches become substantially closed, and the portions bent outwardly in the side wall form semi-cylindrical projections which protrude towards outside from the opposite ends of the remaining intermediate portion of the tube, generally perpendicular to the longitudinal axis.
36. The apparatus according to claim 1, characterized in that the connecting portion is configured to extend through and to settle within a passage formed between the first and second openings.
37. The apparatus according to claim 1, characterized in that the connecting portion is constructed to penetrate through the tissue and is positioned to reside within the surrounding tissue and outside of a passageway which has been formed between the first and second openings.
38. The apparatus according to claim 1, characterized in that the apparatus is adapted to transmit energy to the tissue with which the apparatus comes into contact, whereby a treatment mediated by energy to the tissue is provided.
39. The apparatus according to claim 1, characterized in that the first and second coupling portions comprise annular elements, and wherein the connecting portion comprises: at least one connector element formed on the first housing portion and adapted to be inserted in the second coupling portion when the first and second coupling portions are moved toward each other.
40. The apparatus according to claim 39, characterized in that the connector portion comprises at least one elongate element.
41. The connector apparatus according to claim 1, characterized in that the apparatus further comprises at least one magnet to facilitate the connection of the first coupling portion to the second coupling portion.
42. The connector apparatus according to claim 1, characterized in that the connecting portion comprises a scaffolding to prevent growth towards the passage formed between the first and second anatomical structures.
43. The connector apparatus according to claim 1, characterized in that the connector has a leading edge, and wherein the leading edge is adapted to cut or separate the tissue when the connector is advanced.
44. The connector apparatus according to claim 1, characterized in that the connector has an external cover which is selected from the group of external covers or linings consisting of: a synthetic tubular graft; a natural tubular graft; a chemical coating; an antithrombogenic coating; a thrombolytic coating; and an antimicrobial coating.
45. The connector apparatus according to claim 1, characterized in that the connector further comprises at least one radioactive material to prevent the internal growth of the tissue following the implant.
46. The connector apparatus according to claim 1, characterized in that the connector portion is constructed to pull the first and second coupling portions together.
47. The connector apparatus according to claim 46, characterized in that the pulling of the first and second coupling elements together makes it possible for the connecting apparatus to form connections between the anatomical structures which are separated by varying distances.
48. The connector apparatus according to claim 46, characterized in that the pulling of the first and second coupling elements together serves to minimize the length of the channel wherein the connecting apparatus is implanted.
49. The connector apparatus according to claim 1, characterized in that the connecting portion of the apparatus is constructed to maintain a passageway of a predetermined minimum diameter between the first and second openings formed in the first and second anatomical structures.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US010614 | 1996-02-02 | ||
| US08730496 | 1996-10-11 | ||
| US08730327 | 1996-10-11 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MXPA98006192A true MXPA98006192A (en) | 1999-09-20 |
Family
ID=
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AU723785B2 (en) | Methods and apparatus for connecting openings formed in adjacent blood vessels or other anatomical structures | |
| US11452603B2 (en) | Device and method for modifying the shape of a body organ | |
| JP7177162B2 (en) | Heart valve docking device and system | |
| US10376364B2 (en) | Implant delivery capsule | |
| CN108348735B (en) | Perfusion balloon design | |
| AU2016203206B2 (en) | System and method for assembling a folded percutaneous valve | |
| JP4082736B2 (en) | Medical graft connectors and fasteners | |
| EP2756821B1 (en) | Vascular implant | |
| JP5055124B2 (en) | Prosthesis fixation and deployment device | |
| US20060136034A1 (en) | Delivery catheter and method | |
| US20060136035A1 (en) | Coiled endoluminal prosthesis system and delivery catheter | |
| US20010044621A1 (en) | Endoluminal coiled endoluminal prosthesis | |
| US20040010305A1 (en) | Device and method for modifying the shape of a body organ | |
| US20030057156A1 (en) | Atrial filter implants | |
| EP1951150A1 (en) | Stent with anchoring portion | |
| JP2002542880A (en) | Improved ureteral stent system apparatus and method | |
| WO2008067001A2 (en) | Retrievable implant and method for treatment of mitral regurgitation | |
| JP2002522107A (en) | Arterial repair device and method | |
| US20190015104A1 (en) | Connector and method for coupling anatomical walls | |
| US20230036965A1 (en) | Drainage device | |
| EP1887994A2 (en) | Mechanically actuated stents and apparatus and methods for delivering them | |
| CN113747861A (en) | Systems, devices, and methods for remodeling a valve annulus | |
| KR20230128073A (en) | Drainage device and method of use | |
| MXPA98006192A (en) | Methods and apparatus for connecting openings formed in adjacent blood vessels or other anatomy structures | |
| US20240081991A1 (en) | Systems, devices and methods for delivery systems |