MXPA00009499A - Catheters, systems and methods for percutaneous in situ arterio-venous bypass - Google Patents

Abstract

A system of catheter devices (10), and methods for forming channels or passageways between a luminal anatomical structure (e.g., a blood vessel), a target location (e.g., another blood vessel, an organ, a mass of tissue, etc.) for the purpose of rerouting blood flow or for delivering a substance or instrument, etc. to the target location.

Description

CATHETERS, SYSTEMS AND METHODS FOR PERCUTANEOUS DERIVATION ARTERIO-VENOSA IN SITU Related Request This application claims priority of the provisional US patent application. Serial number 60 / 080,196, with title Methods and Apparatus for Percutaneous in Situ Coronary Artery Bypass (Methods and Apparatus for Percutaneous Coronary Artery Bypass Si tu), presented on March 31, 1998.

Field of the Invention The present invention relates generally to medical devices and methods, and more particularly to catheter devices and methods that are usable to form channels (eg, penetration tracts) between vessels such as arteries and veins as well as between vessels and other structures. anatomical, in addition to a therapeutic purpose such as derivation of an arterial block, supply of therapeutic agents or perform other intervention procedures. Background of the Invention The applicant has invented several new intervention procedures where channels are formed (for example one or several passages for blood flow) between blood vessels, and between blood vessels and other target structures, using catheters that are transluminally advanced. These new procedures include novel percutaneous transluminal techniques to derive obstructions in coronary or peripheral arteries, through the use of the adjacent vein or veins as one or more bypass conduits in itself, and other means for revascularization of oxygen depleted tissues or to provide therapeutic substances to vessels, tissues and other organs. These methods are fully described in U.S. Pat. No. 5,830,222 and in the U.S. patent applications. Serial No. 08 / 730,496, 09 / 048,147 and 09 / 048,147. Some of these procedures can be performed by a venous approach, such as vein-to-artery, where a catheter is inserted for tissue penetration into a vein and the desired arteriovenous passage is initially formed by passing a tissue penetrating element. (for example an energy flow or elongated penetration member) of a catheter, through the wall of the vein where the catheter is placed and towards the lumen of an adjacent artery. Alternatively, some of these procedures may be performed by an artery-to-vein approach, wherein the catheter is inserted into an artery and the desired arteriovenous passage is initially formed by passing a tissue penetrating element (e.g. energy flow or elongated penetration member) from the catheter, through the wall of the artery in which the catheter is placed, and into the lumen of an adjacent vein. Both approaches have been previously described in the U.S. patent application. Serial No. 08 / 730,327. In addition, it may be advantageous to direct a penetrating element directly into other anatomical structures such as the myocardium, pericardium, heart chamber or other organs as described in the US patent application. Serial No. 09 / 048,147. Different considerations and limitations may apply, depending on which of these approaches (the "vein-to-artery approach", the "artery-to-vein" approach or a vessel structure to another anatomical structure) is employed or more generally the size and contour of the blood vessel lumen in which the operating catheters are to be placed, and the distance and / or angle between the vessels or other objective. This is partly due to the fact that in the heart as well as in other areas of the body, adjacent arteries and veins can be of significantly different diameter and significantly different dilatory capacity. In addition, depending on the procedure to be performed, for example, such as the desired angle of channel creation and between blood vessels, one approach may be preferred over the other, to promote, among other things, blood flow channels that stimulate blood flow. not turbulent. As well, the consequences associated with causing a temporary complete blockage of a vein, can be significantly less than the consequences of causing complete temporary blockage of an artery. In this way, it is convenient to design catheters for tissue penetration of the type described above, which are dimensioned, configured and / or equipped differently for use in blood vessels of different sizes, shapes and in connection with different types of pathology. Still further, it is desirable that tissue penetration catheters of the type described above be constructed and equipped for precise direction and control, as the tissue penetration element passes from the catheter through at least the wall of the blood vessel and where locate the catheter and the target site. This direction and control of the tissue penetration element ensure that it will create the desired penetration tract at the intended location with minimal damage or without damage to surrounding tissues or other structures. SUMMARY OF THE INVENTION The present invention provides methods and apparatus for performing the coronary arteriovenous shunt procedures in itself, generally described in U.S. Pat. No. 5,830,222 and the U.S. patent application. No. 08 / 730,327, and other procedures that require the use of accurately positioned catheter elements. A) Devices and Systems. According to this invention, there is provided a system for forming an initial penetration tract of the lumen of a blood vessel in which the catheter is placed at a target site (such as another blood vessel, organ or tissue of the myocardium). This system generally comprises: a) a coronary sinus guide catheter, which is inserted into the venous system of the body and into the coronary sinus of the heart; b) a tissue penetration catheter that is for advancing to a position within a coronary vein, this tissue penetration catheter comprises i) a flexible catheter body, ii) a tissue element. tissue penetration (eg a needle member, electrode or energy flow) that is passed from the catheter body, through the wall of the coronary vein where the catheter body is placed and to the lumen of a coronary artery adjacent or other objective structure, iii) an image forming lumen through which an imaging catheter can be passed (eg, a catheter for intravascular ultrasound imaging IVUS (intravascular ultrasound); and c) a training catheter separate image (e.g., an intravascular ultrasound catheter (IVUS)) that is advanced through the catheter imaging lumen for tissue penetration. In addition to the above a-c components, this catheter system may include a sub-selective and introducer liner. The sub-selective liner comprises a flexible tubular liner, having a proximal end, a distal end and a lumen extending through. The introducer is inserted through the lumen of the liner and has a tapered non-traumatizing distal portion projecting outwardly from and beyond the distal end of the liner, as well as a guidewire lumen extending longitudinally through. The tapered non-traumatic distal portion of the introducer serves to dilate lumens or blood vessel openings, through which the liner is inserted, thereby facilitating the advancement and placement of the liner at a desired location within the body. After the liner has advanced to its desired position within the body, the introducer is removed and various channel modification catheters, catheters for connection supply and / or blocker supply catheters can be advanced through the sub-selective liner . The coronary sinus guide catheter may incorporate a hemostatic valve to prevent contraflow or leakage of blood from its proximal end. Also, the coronary sinus guide catheter may include an introducer that is initially inserted through the lumen of the guiding catheter. This introducer has a tapered non-traumatizing distal portion, which projects outwardly from and beyond the distal end of the guide catheter and a guidewire lumen extends longitudinally through. The tapered non-traumatizing remote portion of the introducer serves to dilate the blood vessel lumens through which the guide catheter is inserted, thereby facilitating the advancement and placement of the coronary sinus guide catheter into the coronary sinus vein. The tissue penetration catheter can incorporate one or more of the following elements to facilitate precise direction and control of the tissue penetration element and the formation of the passage at the desired site: a) Guidance Structure: A structure of orientation may be placed or formed at the distal end of the tissue penetration catheter. This orientation structure has i) a hollow cavity or space formed in the interior, in alignment with the catheter imaging lumen and ii) a marker member placed in direct alignment with the opening in the catheter through which the tissue penetration element (or otherwise in some known spatial relationship to the path that will be followed by the tissue penetration element, as it passes from the tissue penetration catheter). The separate image formation catheter can be advanced through the imaging lumen of the tissue penetration catheter and into the receiving space of the orientation structure. Later, the image formation catheter is usable to image the objective location as well as the marker. The marker image provides a path indication that is indicative of the trajectory that the tissue penetration element will follow as it passes from the tissue penetration catheter. The operator can then adjust the rotational orientation of the tissue penetration catheter as necessary to cause the path or trajectory indication to align with or direct to the target site, thereby indicating that when the tissue penetration member is passed Subsequently from the catheter body, it will advance in the target location and not some other location. In this way, the image forming lumen, separate image formation catheter, and orientation structures that are incorporated in the catheter system of this invention operate, in combination with each other, to provide accurate rotational guidance of the tissue penetration catheter. and directing the tissue penetration element before the penetration element of advancement, thus ensuring that the tissue penetration element enters the desired target at the desired location. In particular, the orientation structure can comprise a plurality (for example 3) of longitudinal reinforcements, these longitudinal reinforcements are placed with respect to a central space in which the IVUS catheter can be advanced. One of the longitudinal reinforcements can be aligned or placed specifically in relation to the trajectory that the tissue penetration element will follow as it passes from the catheter, and from this, providing on the display of the image received from the IVUS catheter, an artifact of another indication that delineates the path or direction in which the tissue penetration element will pass. The tissue penetration catheter can then be selectively rotated to direct the tissue penetrating element into the lumen of the artery or other objective anatomical structure, in which it is intended to pass.

B) Member of Punta Distante Suave. The catheter it may incorporate a soft distal tip member that is formed or mounted at the distal end of the tissue penetration catheter (e.g., the distal aspect of the orientation structure described above). This soft tip member is preferably formed of material that is soft enough to avoid trauma to the walls of the blood vessels through which the tissue penetration catheter is passed. A lumen may extend longitudinally through the soft tip member to allow the operator to selectively advance the IVUS catheter or other device past the distal end of the tissue penetration catheter when blood vessels or other distant local structures are to be imaged. the current portion at the time of the tissue penetration catheter or perform other diagnostic functions with the IVUS catheter or other device. c) Weaving Penetration Member Stabilizer: In embodiments wherein the tissue penetrating element is a needle or other elongated member that is advanced laterally from the catheter body, the tissue penetration catheter may incorporate a stabilizer to prevent or impede that the tissue penetrating member rotates or deviates from a predetermined acceptable penetration zone (APZ = acceptable penetration zone) (hereinafter sometimes referred to as the "stabilizer"). As used herein, the term "stabilizer" shall mean any structural or functional attributes of the catheter and / or tissue penetrating member that prevent or prevent the tissue penetrating member from rotating or otherwise deviating from its intended path of advancement. within a predetermined acceptable penetration zone (APZ). Examples of these structural and / or functional attributes include but are not limited to: a curved remote housing that is formed to constitute mirror image of the curve or shape of the tissue penetrating member, projections or elements for frictional engagement between the member of tissue penetration and the catheter body, bushings or reduced diameter / narrowed lumen regions of the tissue penetration member, which serve to restrain the tissue penetration member, preventing its movement or lateral play side-by-side , permanent magnets or electro-magnets that create a magnetic field that prevents or prevents lateral or rotational movement of the tissue penetration member, etc. More specifically, for example, this stabilizer may comprise one or more of the following: i) a curved needle housing that engages (i.e., has the same direction of curvature) with a preformed curvature that becomes a needle. This coupling of the curvatures of the needle and the needle housing serve to prevent undesired rotation and resultant lateral deviation (tipping or moving or slightly shaking) of the portion of the needle extending out of the catheter body; ii) frictionally coupled surfaces formed in the needle member and surrounding catheter body (e.g., the lumen wall in which the needle member is placed) to latch or prevent rotation of the needle member relative to the catheter body); iii) A steering mechanism for causing the distal portion of the catheter body to curve in the direction in which the needle member is intended to advance to cause the preformed curve of the needle member to correspond to the induced curvature of the body of surrounding catheter; and iv) A laterally deployable needle guide member (e.g., a balloon or rigid annular structure) that is deployable from one side of the tissue penetration catheter adjacent to the exit opening through which the tissue penetration member it passes to support and prevent undesired lateral "play" or "play" of the tissue penetration member as it is advanced from the catheter. This outwardly deployable needle guide member is initially placed in a "stored" position where it does not project (or only project minimally) from the catheter body, and subsequently deploys to an "active" position where it projects laterally from the catheter body, into the area of the opening of needle exit, to provide support and / or guidance for the advancing tissue penetration element (eg, needle member or energy flow), as the tissue penetrating element 1 passes from the catheter body to the target location. This laterally deployable needle guide member may comprise a tubular fist or bend having a lumen. The lumen of this tubular fold can be formed in combination with the catheter lumen where the The tissue penetration element, a curvature corresponding to or adapted to the preformed or intended curvature of the path or path of the tissue penetration element as it passes from the catheter to the target location. In cases where the tissue penetration element is a curved needle, the curvature of the laterally deployable needle guide member and / or catheter lumen may correspond to or be the same as the curvature of the needle member. d) Needle member interlock device: The tissue penetration catheter may incorporate an apparatus that prevents or prevents rotation of the tissue penetration member within the catheter body prior to its advance from the catheter. This rotational interlocking of the tissue penetrating member while in its retracted position serves i) to maintain the desired rotational orientation of the needle member and ii) to improve or couple the transfer of torque from the proximal end of the catheter to the extreme Distant from the needle, without the addition of mass or dimension in cross-section to the catheter body. e) Catheter body construction. The tissue penetrating device may comprise an elongate catheter body 12 with proximal, middle and distant segments of varying flexibility and torque resistance as described more fully in U.S. patent application. Serial No. 08 / 837,294, incorporated herein by reference. Your catheter body may incorporate reinforcing members such as a reinforcing tissue member that imparts structural integrity / stability as well as improves the ability of the catheter body to transmit torque over its length. In addition, it may be important that the reinforcing member maintains the longitudinal integrity of the catheter body and minimizes any variability of the catheter components during operation in the body. B. Methods: In addition, according to the invention methods are provided for using the above-described catheter system to derive an obstruction in a coronary artery by forming one or more arterio-venous passages. Examples of these methods are Derivation of Percutaneous Coronary Artery In si tu (PICAB = Percutaneous In Situ Coronary Artery Bypass), as well as Percutaneous Coronary Venous Arterialization (PICVA Percutaneous Coronary Venous Arterialization). It is understood that the same orientation steps and methods can be employed to access various anatomical structures and targets for placement of a tissue penetration catheter into a blood vessel and orient the catheter in accordance with this invention. i. Derivation of Coronary Artery In If your Percutaneous (PICAB) The PICAB procedure generally comprises the following steps: 1. Introduce a coronary sinus guide catheter into the coronary sinus; 2. Pass a tissue penetration catheter of the type described above through the guiding catheter and into the coronary vein; 3. Place an IVUS catheter or ultra-sound transducer into the orientation structure of the tissue penetration catheter and use the IVUS catheter or ultra-sound transducer to see the artery in which the arteriolar passage is to be extended. venous as well as the marker denoting the path or trajectory that will be followed by the tissue penetration member, as it is advanced from the catheter body; 4. Rotate or move the tissue penetration catheter, as necessary, to cause the needle path indicator generated by the marking to align with the lumen of the artery; and 5. Pass the tissue penetration element from the catheter through the wall of the vein in which the catheter is placed and into the lumen of the artery, thereby forming an initial arterio-venous passage distant from the obstruction. arterial. In some embodiments, the tissue penetrating member has a lumen extending longitudinally through to pass a guide wire from vessel to vessel. 6. Move the catheter to a second site and repeat steps 4-6 to form an initial arterio-venous passage close to the arterial obstruction. 7. Enlarge the arterio-venous passages proximal and distant if necessary, to allow the desired volume of blood flow through these passages. 8. Place the connector (s), stents, I linings or other stent devices or connection within the proximal and / or distant passages, if necessary, to maintain the opening of the passages; and 9. Optionally, if necessary, place one or more blockers within the coronary vein or otherwise completely or partially block the flow of blood through the coronary vein, in one or several sites that drive the arterial blood to circulate from the artery, through the first passage and into the vein, through a segment of the vein, through the second passage and back into the artery (downstream of the blockage), thereby restoring arterial blood flow to the Ischemic myocardium i. Venous Coronary Venous Arterialization (PICVA) In addition in accordance with the present invention, a Percutaneous Coronary In Situ Venous Arterialization (PICVA) procedure is provided, utilizing a prior character catheter system. This preferred PICVA procedure generally comprises the steps of: 1. Introducing a coronary sinus guide catheter into the coronary sinus; 2. Pass a tissue penetration catheter of the type described above, through the guiding catheter and into the coronary vein; 3. Place an IVUS catheter or ultra-sound transducer into the orientation structure of the tissue penetration catheter and use the IVUS catheter or ultra-sound transducer to see the artery in which the arteriolar passage is to be extended. venous as well as the marker denoting the path that will be followed by the tissue penetration member, as it is advanced from the catheter body; Rotate or move the tissue penetration catheter, as necessary to cause the needle path indicator generated by the marking to align with the lumen of the artery; and Pass the tissue penetration element from the catheter through the wall of the vein in which the catheter is placed and towards the lumen of the artery, in this way forming an initial arterio-venous passage distant from arterial obstruction. In some embodiments, the tissue penetration element has a lumen extending longitudinally through for passage of a guide wire from cup to cup. Enlarge the initial arteriovenous passages, if necessary, to allow the desired volume of blood flow through this passage. 20 Place one or more connectors, stents, linings or other endoprosthesis or connection devices within the arterio-venous passage, if necessary to maintain the passage opening; and 8. Optionally if necessary place one or more blockers inside the coronary vein, or otherwise completely or partially block the flow of blood through the coronary vein, in one or several sites that move the arterial blood to flow from the artery, through the arterio-venous passage and into the vein, in such a way that the arterial blood circulates through the vein in a direction opposite to normal venous flow, thus retro-perfusing the ischemic myocardium by arterialization of the coronary vein. Additional aspects and advantages of the present invention will be apparent to those skilled in the art in reading and understanding the detailed description of the preferred embodiments set forth below and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic showing a human being having a tissue penetration catheter system of the present invention inserted percutaneously through a femoral entry site.

Figure la is an exploded side elevational view of a first embodiment of the tissue penetration catheter of the present invention. Figure Ib is an enlarged view of the distal end of the catheter of Figure la. Figure Ib 'is an exploded side view of the catheter body construction of the catheter shaft of a tissue penetration catheter of the present invention. Figure Ib "is a detailed view of the woven construction of the catheter shaft of Figure Ib". The Figure is a cross-sectional view through the row line of Figure la. Figure Id is a cross-sectional view through the Id-Id line of Figure la. Figure 1 is an enlarged side elevational view of the catheter needle stabilizer / housing structure of Figure la. Figure If is a cross-sectional view through line lf-lf of Figure le. Figure 1f 'is a cross-sectional view through line lf-lf of Figure If. Figure 2 is a representation of the intravascular ultrasound image that is obtained when the tissue penetration catheter of Figure 1 is placed within a coronary vein and oriented / directed in an appropriate manner, such that the deployment of its penetrating member will form a penetration tract (i.e. a passage) from the coronary vein to an adjacent coronary artery. Figure 3 is a representation of the intravascular ultrasound image obtained when the tissue penetration catheter of Figure 1 is placed within the coronary vein and inadequately oriented / directed, such that the deployment of its penetrating member of tissue will not form a passage from the coronary vein to the adjacent coronary artery. Figure 4 is a side elevational view of a sub-selective liner and accompanying introducer, which is used in combination with the tissue penetration catheter of the present invention. Figure 4a is a side elevational view of a dilator that is insertable through and used in conjunction with the sub-selective liner of Figure 4. Figure 5 is a partial longitudinal sectional view of the sub-selective liner of Figure 4 having a dilator of Figure 4a operatively inserted therein. Figure 5a is an enlarged cross-sectional view through line 5a-5a of Figure 5.

Figure 6 is an enlarged longitudinal sectional view of the distal portion of the sub-selective liner of Figure 4. Figure 7 is a side elevation view of the tissue piercing needle member of the tissue penetration catheter of the Figure the. Figure 8 is an enlarged side elevational view of the distal end of the needle member of Figure 7. Figure 8b is an enlarged top view of the distal end of the needle member of Figure 7. Figures 9 and 9a show the controller needle / handpiece and distal end, respectively of the tissue penetrating catheter of Figure la, with its tissue penetrating needle member in its retracted position. Figures 10 and 10a show the needle and handpiece driver and distal end respectively of the tissue penetration catheter of Figure 1, with its tissue penetration needle member in its fully advanced position. Figure 10 is a side elevational view of a key insert for rotation inhibition, optional and the corresponding keyed needle member that can be incorporated in the tissue penetration catheters of the present invention, to prevent the penetrating needle member of tissue rotate relative to the catheter body. Figure 10 is a cross-sectional view through line 10d "-10d" of Figure 10, Figure 10"is a cross-section through line 10" -10"of Figure 10d. Figure 10 is a side elevation view of an optional oval inhibitor oval insert and a corresponding oval shaped needle member that can be incorporated into the tissue penetration catheters of the present invention to prevent the needle penetration member from penetrating tissue rotate relative to the catheter body. Figure 10 is a cross-sectional view through line 10e "-10e" of Figure 10. Figure 10 is a cross-sectional view through line 10e "-10e" of Figure 10c. Figure 10F is a partial longitudinal sectional view of a tissue penetration catheter device of the present invention, incorporating an optional locking collar apparatus to prevent the tissue penetration needle member from rotating with respect to the body of the tissue penetrating needle. catheter when the needle member is in its retracted position. Figure 10"is an enlarged view of the region 10" of Figure 10Of. Figure 10 is a side elevation view of a tissue penetration catheter of the present invention having a deployable needle stabilizer laterally positioned in its "stored" position. Figure 10 is a side elevational view of a tissue penetration catheter of the present invention having a deployable needle stabilizer laterally positioned in its "active" position, Figure 11 is a side elevational view of an introducer structure. / coronary sinus guide catheter of the present invention Figure 1 a is a cross-sectional view through the callus line of Figure 11. Figure 11b is an enlarged longitudinal sectional view of the hemostatic valve / proximal end of the coronary sinus guide catheter shown in Figure 11. Figure 11c is an exploded side elevation view of the introducer of the interrupter structure / coronary sinus guide catheter.

Figure 12 is an enlarged cross-sectional view through a coronary artery and adjacent coronary vein, showing the typical difference in diameter of the artery and vein, and delineates a preferred acceptable penetration zone (APZ), where the passages of arterio-venous blood flow of the present invention are formed. Figures 13a-13x are schematic, step-by-step illustrations of a preferred method for performing a coronary arteriovenous shunt procedure in itself (PICAB) to derive a blockage in the proximal left anterior descending coronary artery using an approach of vein-to-artery Figures 14a-14m are schematic stage-by-stage illustrations of a preferred method for performing a percutaneous coronary venous arterialization procedure (PICVA), to provide a retrograde arterial blood flow through a coronary vein. Detailed Description of Preferred Modalities The following detailed description and the drawings to which it refers are provided for the purpose of describing and illustrating certain preferred embodiments or examples of the invention alone and no attempt will be made to exhaustively describe all modalities. possible or examples of the invention. For example, the tissue penetration catheter of this invention can be used at numerous sites in the body to reliably access organs, tissue or other structures to deliver therapeutic substances or procedures. Thus, the following detailed description and the accompanying drawings are not intended to limit, in any way the scope of the claims described in this patent application and any patents or patents issued therefrom. A. The Catheter System: With reference generally to Figures 1 to 12, a presently preferred catheter system of the present invention, generally comprises i) a tissue penetration catheter component 10 (Figures 1-3 and 7- 10a), ii) a sub-selective inserter / liner 100 (Figures 4-6) and iii) an introducer / coronary sinus guide catheter 200 (Figures 11-llc). Each of these components is described in substantial detail below. These components of the catheter system can be packaged together in a single kit or can be provided in separate packages to allow the operator to mix and match component sizes according to the patient's particular anatomy, the size of the channels to be formed, the types of connectors and / or stents and / or blockers to be used, etc.

X. The tissue penetrating catheter component of the system of catheter. With reference to Figures 1-3 and 7-10 a tissue penetration catheter device 10 is illustrated which is inserted into the vasculature of a mammalian patient and used to form passages (eg, perforation tracts) between the blood vessel. wherein the distal end of the catheter device 10 is located and another blood vessel or other anatomical structure. This catheter device 10 generally comprises an elongate flexible catheter body 12 having a proximal portion 12P of a first diameter O1 and a distal portion 12D of a second diameter D2, which is smaller than the first diameter D-L. The catheter body 12 has two (2) lumens 14, 16 extending longitudinally therefrom. The first lumen 14 is dimensioned and configured to allow a commercially available standard IVUS catheter (for example those available from Endosonics of Rancho Cordova, CA; CVIS of Natick, MA or Hewlett Packard of Andover, MA (interns are inserted and slid there; The second lumen 16 is dimensioned and configured to receive a tissue penetration needle member 30 (see Figures 7, 9, and 10) that is alternately movable between a) a retracted position (Figures 9-9a) wherein the Distant end D of the needle member 30 is contained within the catheter body 12 and ii) an extended position (Figures 10-10a) wherein the needle member 30 is advanced out of the catheter body 12 so as to penetrate through the the walls of the blood vessels and through any intermediate tissue located between the blood vessels. to. Orientation Structure: An orientation structure 36 and a tip member 38 are integrally formed with or mounted at the distal end of catheter body 12, as illustrated in FIGS.

Figures Ib, 9a and 10a. The orientation cage 36 comprises first 40, second 42 and third 44 reinforcing members, extending longitudinally between the distal end of the catheter body 12 and the proximal end of the distal tip member 38. The first reinforcing member 40 is in direct longitudinal alignment with a needle exit opening 46, formed on the side of the catheter body 12, through which the tissue penetration needle member 30 is advanced 30. The second and third reinforcing members 42, 44 are located at distances equally spaced from the first reinforcing member 40, while the distance between the second and third reinforcing members 42, 44 is less than the distance between any of those second and third reinforcing members 42, 44 and the first reinforcing member. reinforcement 40. This radial spacing fired (eg uneven) of these reinforcing members 40, 44 and 46 allows the operator to easily identify and distinguish the first reinforcing member 40 of the other two reinforcing members 42, 44 by the image received from an IUDS catheter placed within the orientation structure 36. Thus, in this way, the operator can selectively rotate the catheter body 12 up to that the first reinforcing member 40 is directly aligned or juxtaposed with the target blood vessel in which the needle member 30 is to be advanced. An illustration of this technique is illustrated in Figures 2 and 3. Figure 2 shows the image IVUS that is obtained when the tissue penetration catheter 10 is properly rotated, such that the first reinforcing member 40 is aligned with the target artery A and the needle member 30 is advanced in that target artery A. Figure 3 shows another situation where the tissue penetration catheter 10 is not rotated properly, the first reinforcing member 40 does not align with the target artery A and the needle member 30, if advanced, does not enter the target artery A. It will be appreciated that the distance fired from the reinforcing members 40, 42, 44, is the only possible way to cause the first reinforcing member 40 to be distinguished from the other two reinforcing members 42., 44. Alternatively, the size or configuration of the first reinforcing member may be different to produce a distinguishable ultrasound image or the material or surface characteristics of the first reinforcing member 40 may be made different from the other two reinforcing members 42. , 44, such that the first reinforcing member 40 reflects more or less ultrasound than the other two reinforcing members 44, thereby producing an ultrasound image that differs from the images produced by the other two reinforcing members 42. , 44. It will also be appreciated that only one reinforcing member may be required to provide a distinguishable element to assist in the orientation of the catheter, or alternatively two reinforcing members may be placed to delineate an area, within which the penetrating member may be deployed. of tissue or perform another procedure. Jb. Distant Tip member: Distant tip member 38 is preferably of blunt tip configuration and is formed of smooth soft material (eg PEBAX having a durometer hardness 35D) in order to minimize trauma to the vasculature conforming to the device of the tissue penetration catheter 10 is advanced or otherwise manipulated. A hollow lumen 39 may extend longitudinally through the tip member 38, in alignment with the first lumen 14 of the catheter body 12, such that an IVUS catheter or other device such as a guidewire, may be advanced from the first lumen 14 to through the orientation structure 36, through the distant tip lumen 38 and distally beyond the capital device 10. This allows the operator to use the IVUS catheter to scan areas that are forward of the distant extrusion of the penetrating catheter. tissue, without having to advance the tissue penetration catheter from the present position to the moment. It also allows the catheter device to be introduced into the vasculature in the preferred manner "over the wire". c. Tissue Penetration Needle Member: The tissue penetration member of the tissue penetration catheter may comprise a needle with a sharp tip 30 as illustrated in Figures 7, 8a and 8b. This needle 30 includes a proximal arrow 30p formed of stainless steel hypo-tubing and a resilient curved distal portion 30d formed of a resilient material or more preferably a material such as a NiTi alloy. Preferably, a lumen 31 extends longitudinally through the proximal arrow 30p and the curved remote portion 30b. The particular radius of curvature of the curved remote portion 30d can be an important factor in determining the path and path of the needle tip i as it is advanced and the point at which the needle tip stops when it is in its fully advanced position. . The distal tip of the needle member 30 is preferably tapered so as to easily penetrate through the walls of the blood vessels and any intervening tissue located therebetween. A preferred needle nose configuration is the lancet-type bezel 36t shown in Figures 8a and 8b. This lancet type bezel comprises a first radial surface 36a and a second radial surface 36b. This lancet tip 36 provides excellent tissue penetrability and retains its edge after multiple retractions within / catheter advances. In practice, it may be important that the material surrounding the lumen of the needle, particularly at the distal tip of the needle, and particularly the heel of the needle lumen 36c be smooth and free of rough edges, protuberances or burrs. This allows uniform passage of the devices such as guide wires through the needle lumen. In many applications, the control and direction capability of the needle member 30 can be improved by restricting the needle member 30 such that it remains in a preferred plane or acceptable penetration zone APZ., as illustrated in Figure 12, as it is advanced from the catheter. In embodiments wherein a curved needle member 30 is advanced out of a lateral opening in the catheter (e.g., in the embodiment shown in Figure 10a) any rotation of the needle member 30 prior to, during or after advancement of the limb member. needle 30 may cause the distal end of the curved needle member to deviate or move away from the intended plane or acceptable penetration zone APZ. In this aspect, the potential for unwanted lateral movement of the distal end of the needle member 30 can be avoided or substantially limited by providing a stabilizer to substantially prevent or limit the amount of rotation the needle member 30 can subject to the body. of catheter 12 or otherwise prevent or prevent the needle member from deviating from a predetermined acceptable penetration zone APZ (Figure 12) as it is advanced from the catheter 10. In particular, by avoiding or limiting the rotation 100 of the member of needle 30 within needle lumen 16, the curved distant portion of the needle member is prevented from bypassing the intended path of advancement as it extends laterally from catheter body 12 (see Figure 10a). This prevention or limitation of the rotational or lateral movement potential of the needle member 30 can be achieved in any convenient manner. As described in detail below, specific apparatuses that can be incorporated into the catheter device 10 to prevent or prevent rotation or lateral movement (i.e. "tipping over" or "shaking") of the needle member 30 during or after its advance from the catheter body 12, include: a) a curved needle housing 60 having a curve at its distal end, which corresponds to the preformed curvature of the needle member 30 to prevent rotation (see Figures 9 - lOf); b) coupled surfaces 76, 77 formed in the needle member 30 and the surrounding catheter body 12 to interlock or prevent rotation of the needle member 30, examples of these coupled surfaces 76, 77 including but not necessarily limited to i) a key or tongue and groove in a keyway assembly (see Figures 10B-10B ") or ii) an oval to oval mounting member (see Figures 10e-10"), etc. c) a steering mechanism for causing the distal portion of the catheter body 12 to bend in the lateral direction where the needle member 30 is intended to advance in order to cause the preformed curve of the needle member 30 to correspond with the induced curvature of the catheter body 12; and d. A needle guide member 500 projecting laterally from the catheter body 12 in the area of the needle exit aperture 46 to support the needle member 30 and / or form a lateral extension of the needle lumen 16, so as to of creating a lateral curve in the needle lumen corresponding to the preformed curvature of the needle member 30 (see Figure 10). i. Curved Needle Housing to Prevent Rotation / Lateral Deviation of the Extended Needle.

An example of a preferred curved needle housing 60 that is mounted within the needle lumen 16, is specifically illustrated in Figures lb-lf. This needle housing 60 comprises a curved rigid tube. A tubular liner 71 can be placed inside and can extend from either end of the curved needle housing 60. This tubular liner 61 can be formed of a three-layer composite, wherein the inner layer is a polymeric lubricant material (eg polytetrafluoroethylene PTFE). ), the middle layer is a structural polymer material (e.g. polyimide) and the outer layer is an adhesive material that will bond to the inner surface of the curved needle housing 60 and to the inner surface of the needle lumen 16 at either end of the housing 60 (for example polyurethane adhesive). When the needle member 30 is in its retracted position (Figures 9 and 9a) and during advancement, the needle member portion that resides within the needle housing 60 will remain in a slightly curved state in compliance with the slightly curved configuration of the housing Needle 60. It is possible to prevent rotation of the needle member 30 relative to the catheter body 12 and / or to undergo uncontrolled movement (ie "toppling") out of the intended acceptable penetration zone APZ during or after advancement of the catheter. This prevention or impediment of rotation of the needle member 60 allows the operator to control the orientation of the lancet type or other bevel formed in the needle tip, and also improves the ability of the operator to predict the precise placement of the needle tip to the eliminate or minimize uncontrolled side-to-side movement of the needle. To facilitate the location and desired orientation of the curved needle housing 60 during manufacture of the catheter 10, a locator member 62 can be connected to the needle housing 60 and incorporated into the catheter body 12 as illustrated in Figures Ib, le, lf, 11, 9a and 10a. This locator member 62 comprises a rigid disk 64 which is positioned transversely within the catheter body, having a first bore 66 and a second bore 68 extending longitudinally through. A chamfered edge 69 is formed with respect to the proximal end of the first bore 66 as illustrated in Figures lf and lf '. During fabrication of the catheter body 12, a rod or mandrel is inserted through the first perforation 66 of the locator and into the first lumen 14 of the proximal catheter body portion 12P and the curved needle housing 60 having a tubular liner. 61 which extends through and protrudes from either end and inserts through the second perforation 68 and into the second lumen 16 of the proximal catheter body portion 12P. Subsequently, a distant plastic tube is advanced with respect to the locator, a surface layer of tubular polymer 73 is applied and the compound is then heated to form the distal portion of the catheter body 12 as illustrated. ii. Frictionally Coupled Surfaces of the Member of Needle and Catheter, To Prevent Rotation / Lateral Deviation of Extended Needle: As an alternative to, or in addition to, the use of the curved needle housing 60 as a means to prevent rotation of the needle member 30 and allow further deployment Precise and stable of the needle member 30, the needle member 30 and at least a portion of the second lumen 14 can incorporate coupled surfaces, which frictionally engage each other in order to prevent or prevent rotation of the needle member 30 within the lumen Needle 16. Examples of these coupled surfaces 76, 77 include a key / keyway design shown in Figures 10O-10O "or an oval / oval design such as that illustrated in Figures 11Oe-10e". With specific reference to the illustrations of the Figures lOd-lOd ", the key / keyway method to prevent independent rotation of the needle member 30 can be effected by the use of a keyway element 76 in combination with a 30key keyed needle. The keyway element 76 comprises a tubular member having a key-shaped lumen 77, a key portion 79, extending longitudinally through. The 30key keyed needle comprises a hollow needle of the type previously described illustrated in Figures 7 -8b having a longitudinally extending key or rail member 33 formed on a segment. The key member 33 may be formed as a portion of the needle wall or may alternatively comprise a spacer member such as a hypo-tube section, fixed to the side of the needle wall. The keyed needle 30key is sized and configured to be advanced and retracted through the lumen 77 of the keyway housing, with the key member 31 being positioned within the key portion 79 of the lumen 77. In this manner, the needle member 30key keying is advanced and retracted longitudinally, but can not be rotated within the lumen 77 due to engagement of the needle key member 31 with the key portion 79 of the lumen 77. The keyway element 77 is provided as a stabilizer 78 which is substantially same as the needle housing stabilizer 72 described above and shown in FIGS. 1-lf "and the structure of the keyway element 76 / stabilizer 78 can be installed and mounted within the catheter body at the time of manufacture in the same manner as previously described with respect to the needle housing structure 60 / stabilizer 62 shown in Figures le-lf ". This keyway element assembly 76 / stabilizer 78 is typically installed and mounted to the catheter body 14 proximate the location of the needle housing structure 60 / locator 62 shown in FIGS. 1-lf, but sufficiently close to the end. Distant from the catheter device 10 to prevent the portion of the needle adjacent its distal end from being subjected to unfavorable rotation within the catheter body 12 during the catheter insertion procedure. With specific reference to the oval / oval arrangement shown in Figures 10E-10e, the device 10 may incorporate an oval-shaped needle housing 76alt in combination with an oval shaped needle 30od.The oval-shaped needle housing 76alt comprises a tubular member positioned within the needle lumen 16 and having an oval-shaped lumen 76alt extending longitudinally through.The oval shaped needle 30ob comprises a hollow needle of the type previously described and shown in Figures 7-8b having a oval, ovoid or other non-round cross-sectional configuration The oval-shaped needle 30ob is sized and configured to be advanced and retracted through the lumen 77alt of the oval shaped needle housing 76alt, but can not be rotated within the lumen 77alt to the coupling of the needle member (oval shaped 30b to the oval shaped wall of the housing lumen 77alt) The oval shaped needle housing 76alt is provided with a locator 78 which is substantially the same as the needle housing locator 62 described above and shown in FIGS. 1-lf ", and the oval-shaped needle housing structure 76alt / locator 78 can be installed and mounted within the body of the needle. catheter 12 at the time of manufacture, in the same manner as previously described with respect to the needle housing structure 60 / locator 62 shown in Figures le-lf ". This oval-shaped needle housing 76alt / locator 78 will typically be installed and mounted on the catheter body 12 near the location of the needle housing structure 60 / locator 62 shown in FIGS. near the distal end of the catheter device 10, to prevent the portion of the needle 30ob adjacent its distal end from being subjected to undesired rotation within the catheter body 12 during the catheter insertion procedure. iii. Laterally deployable needle guide for Preventing Rotation / Lateral Deviation of the Extended Needle: Figures 10O and 10O1 show an example of a needle guide member 500, which can be caused to project or extend laterally from the catheter body 12 in the area of the exit opening of the needle. needle 46 for stabilizing and guiding the advancing needle member, thereby preventing lateral or side-to-side movement of the needle member 30 and further restricting the path that will be followed by the advancing needle. The deployment of this needle guide member 500 can also result in lateral extension of the needle lumen 16 which corresponds to the preformed curve of the needle member 30, to prevent rotation of the needle member 30 in essentially the same way as the needle housing. curved needle 60 described above. The particular laterally deployable guide member 500 based on FIGS. 10g-10g 'is an inflatable annular member which is connected to a lumen of inflation fluid 502, which extends through the catheter body 12, to allow inflating fluid to infuse and withdraw from the inflatable guide member 500. When deflated (Figure 10), the guide member 500 will be housed within a depression or region of cut in the catheter exterior wall, thereby acquiring a configuration that is substantially level with the outer surface 504 of the catheter body 2. When inflated (Figure 10g ') the guide member 500 will form an annular support collar around the tissue penetrating member 30, as it advances laterally from the catheter body. The surface or surfaces of the inflatable guide member 500 that can be brushed against or contacted by the tip of the brush penetration body, as it is advanced from the exit aperture 46, can be protected or coated with a thin sheet of metal or other material that resists piercing by the tip of the tissue penetration member 30. iv. Airship Catheter Body to Prevent Rotation / Lateral Deviation of the Extended Needle Member: The catheter body 12 may be provided with a mechanism for inducing a curve or elbow in the region of the catheter body 12 proximate the needle exit aperture 46, to cause the portion of the Needle lumen 16 proximate the outlet opening 46 acquires a curvature corresponding to the curved shape to which it is derived from the needle member 30, thereby preventing rotation of the needle member 30 within the catheter in the same manner described above with respect to the curved needle housing 60. The mechanism by which the catheter body can be induced to bend can be any convenient catheter direction apparatus, known in the art, such as a spine member or internal pull wire formed alloy with shape memory that alternates between a straight configuration and a curved configuration. Y. A Rotational Interlock of the Mi embro When Retracting Rods Maintain Correct Orination and Improve Torque Transference: It is desirable that the proximal shaft of tissue penetration catheter 10 be provided with sufficient structural integrity to transmit torque to the distal end of the catheter, as it is necessary for precise rotational orientation and direction of the catheter device 10 before advancement of the needle member 30 therefrom. Also, in many applications, it is desirable that the needle member 30 be held in a predetermined rotational orientation within the catheter body 12 prior to advancement of the needle member 30 from the catheter 10. (ie, while the water member 30 is still in its retracted state). In many applications, it is also convenient to minimize the diameter of the catheter body 12 to allow it to pass through the lumens of the small blood vessel. Each of these three (3) targets can be achieved by rotational interlocking of the needle member 30 within the catheter body prior to its advance from the catheter, since this rotational interlock i) prevents unwanted needle rotation, ii) improves the torque transfer efficiency to the distal end of the catheter body 12 and thus the needle, and iii) does not add any mass or additional diameter to the catheter body 12. Figures 10F-10F 'show a needle interlock collar structure 520, comprising an enlarged region 522 formed within the needle lumen 16, wherein a first interlock collar member 524 is located and a second locking collar member 526. The first locking collar member 524 is stationary fixed to the catheter body 12 and has cavities or grooves 528 formed in its distal surface and a central opening through which the needle member 30col it can be advanced and retracted. The second interlocking collar member 526 is fixed to the needle member 30col and has projections 530 extending from its proximal surface. The projections 530 are dimensioned, located and configured to be received within the slots 528 of the first collar member 524, when the needle member 30col is in its retracted position, thereby frictionally locking the needle member 30col to prevent rotation thereof. to the catheter body 12. However, when the needle member 30col is in its extended position, the projections 530 will not be inserted into the slots 528 and the collar structure 520 will not prevent the needle member 30coi from rotating within the body of catheter 12. It will be appreciated that these stabilizing devices can be employed at various points on the length of the catheter body, including the proximal, middle, distal, or needle housing portion. d. Acru a / Handpiece Controller: A needle / handpiece controller 15 is mounted on the proximal end of the catheter body 12 and is usable to control the rotational orientation of the catheter body 12 and the advance / retraction of the catheter member 12. needle 30. Also, this handpiece / needle driver 15 has a proximal gate 27 formed at its proximal end through which a small guidewire can be advanced (eg a wire with diameter 0.003 to 0.041 cm (0.0010 - 0.016 inch)) through lumen 31 of needle member 30, a first side gate 21 through which a large guidewire (eg a wire of 0.076 to 0.102 cm (0.030-0.040 inch) diameter) can be advanced through of the first lumen 14 when this first lumen 14 is not occupied by an IVUS catheter, and a second lateral gate 23 through which a flushing solution can be infused into the second catheter lumen 16 outside the needle member 30 there placed. H.H. Catheter body: The catheter body 12 includes a relatively rigid proximal section 12a, a middle section 12b and a distal section 12c shown in Figures la and Ib. The catheter body exhibits variant flexibility and torsional strength over its length and may incorporate reinforcing members, such as a reinforcing tissue member imparting structural integrity as well as improving the ability of the catheter body to transmit torque. A hand piece 15 is connected to the proximal end of the proximal section 12a, as illustrated. In the preferred embodiment, the hand piece 15 and the proximal section 12a are approximately 115 cm long. the middle section extends approximately 25 cm terminating approximately 12 cm from the distal section 12c. The proximal and middle sections of the catheter contain a tissue component 50 as illustrated in Figures IB1 and an IB ", circumscribed in a polymeric material (e.g. PEBAX, nylon, polyurethane, polyester or PVC), extruded to form the inner lumen. 50b and the outer jacket 50a of the catheter body 12. It has been determined that the expansion of material and changes in the physical properties of certain Materials can occur after the catheter 10 is inserted into the patient's body and heated from room temperature to body temperature. This expansion of material and changes in the physical properties of certain materials can result in variation in the tolerances and sizing of the catheter 10 (for example elongation or shrinkage) and thus may result in an undesired modification of the position of the penetrating member. of tissue 30. This can, at least in certain cases interfering with the orientation and precise advancement of the tissue penetration member as desired. The figure IB "illustrates the tissue angle A and the thread count (PC = pick count) of the catheter tissue 50. The" thread count "PC of the tissue, as is well known in the art, is a function of the angle of fabric A (ie, the greater the angle of fabric, the greater the yarns per 2.54 cm (inch)). Also, the torque and stiffness transmission of the woven section 50 is a function of the woven angle (i.e. a woven angle of 90 degrees provides maximum torque transfer and a woven angle of 0 degrees provides minimal transfer of torque). Catheters employed in the present invention that have exhibited this phenomenon have tissue angles A that result in a yarn count of 50 to 70 yarns per 2.54 cm (inch). However, the applicant has determined that decreasing the tissue angle A of the tissue 50 within the proximal and middle sections of the catheter 10 results in a thread count of 20 to 30 strands per 2.54 cm (inch), it is possible to minimize or eliminating the undesirable longitudinal expansion of the catheter 10 and / or its components, while retaining sufficient torque transmission and acceptable stiffness, to achieve the procedures for which the catheter 10 is intended (examples of these procedures are illustrated in the Figures 13a-14m below). This variation in fabric angle or yarns per 2.54 cm (inch) may vary depending on the construction material of the catheter and / or the tissue fiber and the diameter of the catheter body. II. The Coronary Sinus Guiding Component of Catheter System: Figures 11-11c show a preferred coronary sinus guidewire introducer / catheter structure 200, comprising a) a flexible coronary sinus guide catheter 203 having a curved distal portion 204, a proximal structure 214 mounted thereon. proximal end of the flexible catheter body 203 and a hollow lumen 202 extending longitudinally through and b) an introducer 213 having a smooth, tapered distal portion 213d projecting out of and beyond the distal end of the guide catheter 203 and a guide wire lumen 215 extending longitudinally through the introducer 213, to allow the introducer / guide catheter structure to be advanced over a guide wire GW as described more fully below in connection with a preferred method for using the system of catheter 10. A reinforcing tissue 212, such as a wire weave, is formed within a portion of the catheter body. 3 but ends approximately 2 to 5 centimeters from the far end of DE. In this way, the reinforcement fabric 212 will prevent knotting and improve the torque resistance of the proximal portion of the catheter body 203 and its curved portion, to a site approximately 2 to 5 centimeters from its distal end DE. The proximal structure comprises a rigid body 248 through which the lumen 202 extends and over which a proximal gate 250 is formed, to allow the guide introducer 213, sub-selective liner 100 (FIGS. 4-6) tissue penetration catheter 10 (Figures 1 and 9-10) or other catheters, guidewires and / or devices (eg, blocker delivery catheter, channel connector supply catheter, channel enlarging device, etc.) , are inserted through the lumen 202 of the coronary sinus guide catheter 200. A hemostatic valve 244, such as a resilient cross-sectional membrane, a resilient slot-cut membrane or a flap or butterfly valve) is placed transversely within of lumen 202 of proximal structure 214 to prevent blood from having retro-flow from the proximal gate 250, when no catheter or other device is inserted through and to prevent or minimize the amount of blood that may leak from the proximal gate 250, when a catheter or other through device is inserted. A side gate 246 is formed in the proximal structure 214 to allow preparation fluid to be instilled or injected into or through the lumen 202. A plurality of lateral openings 210 are formed in the wall of the catheter body 203 near its distal end, so as to allow pressure relief in the event that a radiographic contrast medium or other fluid is injected. iii. The Sub-selective Liner Component of Catheter System, As illustrated in Figures 4-6, a preferred sub-selective liner 100 of the present invention comprises a flexible liner body 102 having a proximal hub 104 and a lumen 106 extending longitudinally through. A reinforcing fabric 108 is formed within the catheter body 102 to prevent entanglement and improve torque resistance. This reinforcing tissue terminates distally at 0.1-1.0 cm from the distal end of the catheter body 102. A gradual taper 110 is formed with respect to the distal end of the outer surface of the liner body, such that the liner 100 abuts on a level transition with the portion projecting away from its introducer 111. The lumen 202 has an inner diameter ID that is substantially the same as the outer diameter of the introducer 111 that is initially inserted through the lumen 106. The introducer 111 has a guidewire lumen 109 extending longitudinally through to allow the sub-selective liner structure / introducer to be advanced over a pre-inserted guidewire GW (e.g., a .035 inch guidewire). The outer diameter of liner 100 is dimensioned to advance and retract through lumen 202 of coronary sinus guide catheter 200 (Figures 11-llb). The preferred method of using this sub-selective liner 100 and introducer 111 is described in detail below with respect to the methods of the present invention. B. Preferred Methods for Using the Catheter System: The present invention also includes methods for utilizing this previously described catheter system (or any other catheter system or devices that may be suitable for carrying out the intended purpose), as a whole with other apparatus such as guidewires, canal enlargement devices / catheters, channel connection catheters / devices, and catheter devices / catheters for performing coronary arteriovenous bypass procedures per se, percutaneous by a vein approach. a-artery, this method is fully described below and illustrated in a step-by-step manner in Figures 13a-13x and 14a-14m. The catheter system previously described and shown in Figures 1-llb is usable in conjunction with a fluoroscope, an IVUS imaging catheter, a coronary sinus access catheter (for example a standard angiographic catheter), a catheter device for channel enlargement, one or more lumen locking devices, a guidewire with a diameter of .091 cm (0.35 inch), and one or more guide wire with diameter of .036 cm (0.14 inch) to perform various revascularization procedures including, as described in detail below, a Percutaneous In Situ Coronary Artery Bypass Procedure (PICAB) as well as a Venous Arterialization Procedure Coronaria In Situ Percutaneous PICVA. It will be appreciated that, in addition to the particular PICAB and PICVA examples described in detail below, the catheter system of the present invention may also be usable to perform various other procedures such as liquid drug delivery procedures, of the type described in the application. of US patent co-pending Serial No. 09 / 048,147 and other revascularization procedures. I. A preferred method for performing the PICAB method: Figures 13a-13x show, in stage-by-stage form, an example of a PICAB method wherein the catheter system 10 of the present invention is used for the purpose of deriving a blockade located in the proximal portion of the anterior descending coronary artery (LAD) of a human patient. In this PICAB procedure, a coronary sinus access catheter (e.g., a standard angiographic catheter such as the modified Simmons-type angiographic catheter available from Cook Cardiology, Bloomington, Indiana (is inserted initially through a femoral vein or an approach or external jugular vein approach using a standard percutaneous catheter insertion technique After this initial percutaneous catheter insertion has been achieved, the PICAB procedure proceeds as follows: First stage: Introduction / Breast access First Wire Coronary Guide: As illustrated in Figure 13a, an arterial block (AB = Arterial Blockage) to be derived is located in the left anterior descending coronary artery (LAD = Left Anterior Descending). The coronary sinus access catheter 500 is advanced to the coronary sinus (CS = Coronary Sinus), as illustrated in Figure 13b, to assist in the placement of a GWX guidewire with a diameter of .091 cm (.035 inch) inside. of the large coronary vein (GCV = Great Cardiac Vein) and the anterior interventricular vein (AV = Anterior Interventricular Vein). This guidewire GW] _ can be pre-loaded into the lumen of the coronary sinus access catheter 500 or can be advanced through the lumen of the coronary sinus access catheter 500, after it has been placed in the coronary sinus as a separate stage. Subsequently, the coronary sinus access catheter 500 is removed, leaving the GWX guide wire of .091 cm (.035 inch) in place. Second stage: Introduction of coronary sinus guide catheter / AIV access:. As illustrated in Figures 13c-13d, the coronary sinus guide catheter 200 with the introducer liner 100 disposed within or through its lumen 202 is advanced over the .035 inch GWX guidewire until the tip of the coronary sinus guidewire 200 passes the "mouth" of the coronary sinus. The introducer liner 100 is then removed, leaving the coronary sinus guide catheter 200 in place, in the manner shown in Figure 13d. Third stage: Introduction? Direction of Tissue Penetration Catheter: As illustrated in Figure 13e, the tissue penetration catheter 10 is then inserted over the pre-positioned .091 cm (.035 inch) GW-L guidewire, through lumen 202 of the coronary sinus guidewire 200, and is advanced using fluoroscopy to a position distant from the arterial AB block that is derived. The .035 inch GWX guidewire is then removed and removed from the first lumen 14 of tissue penetration catheter 10 and an IVUS imaging catheter (not shown) then advanced through this first lumen. 10 until the IVUS transducer resides within the hollow interior space of the orientation structure 36. The IVUS catheter is then used to receive a 360 degree ultrasound image from an advantageous point within the interior space of the orientation structure 36. This image allows the operator to see both the resident vessel (the AIV) and the target vessel (the LAD) as well as the reflections or artifacts of the three column members 40, 42 and 44 of the orientation structure 36. Due to the distance fired between the column members 40, 42 and 44, the reflections or artifacts produced by the column members will form a generally "Y" shaped image as illustrated in Figures 2 and 3 of this application. and patent. The reflection 400Ref produced by the first column member 40 is clearly distinguishable from the reflections 42Bef, 44Ref produced by the second and third column members 42 and 43 and provide an indication of the vascular direction where the needle member 30 will travel when is advanced from the needle exit aperture 46 on the body side of the catheter 12. Thus, if the reflection of the first column member 40Ref observed in the IVUS image does not extend directly into or into the lumen of the LAD (as illustrated in Figure 3), the operator will rotate the tissue penetration catheter 10 until this reflection of the first column member 40Ref observed in the IVUS image extends directly into or within the lumen of the LAD (as illustrated in FIG. Figure 2). This will ensure that the needle member 30 is properly directed to enter the LAD when it is advanced. Fourth stage: Formation of Penetration Tract Arteri - Initial Vein Distant to Blockage: As illustrated in Figures 13f-13h, the penetration needle member of tissue 30 is then advanced in the direction distant to its extended position so that it pierces through the wall of the resilient vessel (the AIV) through any tissue that may exist between the resilient vessel (the AIV) and the target vessel (the LAD) and towards the lumen of the target vessel (the LAD) at a site downstream of the AB arterial block. This maneuver results in the formation of an initial arterio-venous penetrating tract PT. With the needle member 30 in its extended position and its distal tip in the lumen of the target vessel (the LAD) a GW2 guide wire with a diameter of .355 cmm (.014 inch) is inserted through the next gate 27 of the controller needle / manual piece of fabric penetration catheter 15 and advanced through lumen 31 of needle member 30 into the target vessel (the LAD) as illustrated in Figure 14h. After the .355 cmm (.014 inch) diameter GW2 guidewire has been inserted into the target vessel (the LAD) the needle member 30 is retracted into its retracted position, leaving the guidewire with diameter at .355 cmm (.014 inch) GW2 extending through the interstitial passage formed initially to the target vessel (the LAD) as illustrated in Figure 14h. After the needle member 30 is withdrawn to its retracted position, the tissue penetration catheter 10 is removed, leaving the guide wire .355 cmm (.014 inch) in place (i.e., extending through the arteriovenous penetrating tract). venous PCs recently formed). Fifth Step: Deployment of Blocker in Vein Lumen Distant to Blockage: As illustrated in Figures 13i-13k, the sub-selective liner 100 with its inserter inserter 111 inserted is advanced through the coronary sinus guide 200 over the wire large guide GWX. Subsequently, the introducer 111 and the GWX guidewire are removed and one or more BM embolic blocking members are introduced into the proximal end of the sub-selective liner, pushing through the lumen of the sub-selective liner 100 using a push rod (not shown) ejected into the lumen. of the coronary vein (AIV) where the embolic blocker (s) expand and attach to the wall of the vein to cause substantial occlusion and block blood flow through the vein at that site. Examples of these BM blocking members and their implanting methods are described in US patent application. Serial No. 09 / 117,176. The guide wire G j. with diameter .089 cm (.035 inch) is then removed and a BM embolic blocker member is inserted into the proximal end of the sub-selective liner. A push rod is then advanced through the lumen, of the sub-selective lining, to push the embolic blocker member BM out of the distal end of the sub-selective liner and into its desired position within the lumen of the coronary vein (the AIV). . It will be noted that this blocker deployment step can be performed at this point in the procedure, or alternatively it can be delayed until a later time in the procedure. After the remote blocking member BM has been implanted in the desired location, the GWX guidewire with a diameter of .089, cm (.035 inch) is reinserted through the sub-selective liner 100 and the sub-selective liner 100 is then extract and remove as illustrated in Figure 13k. Sixth Stage: Penetration Tract Formation Initial Arterio-venous Locking: As illustrated in Figures 131-13n, the tissue penetration catheter 10 is again advanced over the guidewire with .035 cm diameter (.035 inch) GWX, under fluoroscopy, to a position close to the previously formed remote penetration tract PT. The fourth step described above is then repeated to form another initial arteriovenous penetrating tract PT close to the blockage, and to pass to a second 0.355 cmm (.014 inch) GW3 guidewire through that second tract of penetration arterio-venous PT. The tissue penetration catheter 10 is then removed and removed, leaving both .355 cmm (.014 inch) GWX and GW3 guidewires in place, in the manner shown in Figure 13n. Seventh Stage: Acrr andami nto Tract of i Distant Penetration to form Blood Flow Passage Arteri o-Venosa: As illustrated in Figure 13o, the sub-selective liner 100 and its introducer 111 are advanced through the guide catheter 203 over the second guide wire GW2 to a site where the distal end of the sub-selective liner 100 is within the AIV immediately adjacent to the distant penetration tract PT. Subsequently, the introducer 111 is removed and a catheter device for enlargement of the CEC channel, of the type described in the patent application of the U.S.A. No. 09 / 056,589, advancement is made on the .355 cm (.014 inch) GW2 guidewire extending through the distant arteriovenous penetrating tract PT, thereby dilating or enlarging that tract to form a passageway. arterio-venous blood flow PW. This stage of the procedure provides control over the diameter or size of the arteriovenous blood flow passages PW and assists in ensuring that the PW passages remain open and functional after the completion of the procedure. After this enlargement of the penetration tract to form the intended PW passage, the CEC channel enlargement catheter device is withdrawn and removed together with the sub-selective liner 100, leaving both guide wires G1 and GW3 of .355 cm (.014 inch) on site, in the manner shown in Figure 13p. Eighth Step: Displacement Placement Connector in the Distal Arterio-venous Blood Flow Passage: As an optional step, a connector device can be deployed in the PW passageway. As illustrated in Figures 13q - 13s, the sub-selective liner 100 and its introducer 111 are then advanced over the remote channel guidewire GW2, to a position where the distal end of the sub-selective liner 100 is in the AIV immediately adjacent to the distant blood flow passage PW Subsequently, the introducer 111 is withdrawn and a catheter for supplying the CDC connector device? of the type described in the U.S. patent application. Serial No. 08 / 970,694, is advanced through the sub-selective liner 100 and over the .355 cm (.014 inch) GW2 guidewire extending through the distant arteriovenous pass PW, to implant a device CD connector inside that PW passage. The CDC connector delivery catheter device is then removed, along with the sub-selective liner 100 and the distant GW2 .355 cm (.014 inch) guidewire that extended through the distant arteriovenous passageway PW, leaving the device CD distant connector in place within the distant arterio-venous passage PW in the manner shown in Figure 13s. Ninth Stage: Enlargement of the Tract of Next Penetration to form the Flow Passage of Next Arteriovenous Blood As illustrated in Figures 13t-13u, the sub-selective liner 100 and its introducer 111 are then advanced over the distant channel guidewire GW2 to a position where the distal end of the sub-selective liner 100 it is in the AIV immediately adjacent to the distant blood flow passage PW. Subsequently, the introducer 111 is removed and a catheter device for enlargement of the CS channel, of the type described in the patent application of the U.S.A. No. 09 / 056,589, advancement is made on the .355 cm (.014 inch) GW3 guidewire extending through the proximal arteriovenous penetrating tract PT, thereby dilating or enlarging this tract to form a passageway for arterio-venous blood flow next PW. This process step provides control over the diameter or size of the arteriovenous blood flow passages PW and assists in ensuring that the PW passages remain open and functional after finishing the procedure. After this enlargement of the proximal penetration tract to form the intended PW passage, the CS channel enlargement catheter device is withdrawn and removed leaving the sub-selective liner 100 and the proximal guidewire GW3 of .355 cm (.014 inch. ) on site, as illustrated in Figure 13u. Tenth Stage: Placement of Device Connector in the Artery-venous Passage Next: As an optional stage, a connection device can be deployed in the PW passage. As illustrated in Figure 13v, a CS connectivity device delivery catheter of the type described in US patent application. Serial No. 08 / 970,694, then advanced through sub-selective liner 100 and over the .355 cm (.014 inch) GW3 guidewire extending through the proximal arteriovenous passageway PW, to implant a CD connector device inside that PW passage. The connector delivery catheter device is then removed, and the sub-selective liner 100 and the GW3 .355 cm (.014 inch) guide wire are then retracted to a position within the large GCV cardiac vein proximal to the proximal PW passage. , as illustrated in Figure 13w, leaving the connector device next CV in place within the proximal arterio-venous passage. Eleventh Stage: Deployment of Blocker in the Lumen de Vena Close to the Block: As illustrated in Figure 13w, the fifth stage described above is then repeated to implant a second DV blocking device into the lumen of the large cardiac vein (GCV) close to the arterio-venous passage, next PW . This completes the procedure, and results in arterial blood flow from the circumflex artery (CX) through the proximal arterio-venous passage PW, through the large GCV cardiac vein and anterior interventricular vein in the retrograde ction, through the distant arterio-venous passage PW and into the left anterior descending coronary artery LAD, current below the AB block as illustrated by the flow indicator arrows in Figure 13x. II. A Preferred Method to Perform the FIG. 14a-14m show, in a step-by-step manner, an example of a PICBA method in which the catheter system 10 of the present invention is used for the purpose of causing arterial blood ct to the anterior interventricular vein and cause it to subsequently flow through the IVA in retrograde fashion (ie in a normal opposite ction to venous return) thereby leading to extensive blockage within the patient's anterior descending coronary artery (LAD) and perfusing the region of the myocardium that has become ischemic due to extensive blockage in the LAD. In this PIVA procedure, a coronary sinus access catheter (eg, a standard angiographic catheter such as the modified Simmons-type angiographic catheter available from CWK Cardiology, Bloomington, Indiana) is initially inserted through a femoral vein or an approach of external jugular vein, using a standard percutaneous catheter insertion technique. After this initial percutaneous catheter insertion has been achieved, the PICAV procedure continues as follows: P age Stage: Breast access Coronary / Introduction of the First Guide Wire: As illustrated in Figure 14a, an extensive AB arterial block extends across substantially the entire length of the left anterior descending coronary artery (LAD) thus making this patient unlikely candidate for the PICAB procedure described above because no open distal portion of the LAD remains available to receive the arterial blood flow bypass. It is appreciated that in cases where the diseased AB does not extend into the proximal portion of the LAD, a connection may be made between the LAD and the AIV close to the block, but there would be no opportunity to make a distant connection as required by the PICAB procedure. . As shown in Figure 14, a coronary sinus access catheter 500 is advanced to the coronary sinus CS, to assist in the placement of a GWX guidewire with a diameter of .035 cm (.035 inch) into the large cardiac vein. GCV. This GWX guide wire can be pre-loaded into the lumen of the coronary sinus access catheter 500 or can be advanced through the lumen of the coronary sinus access catheter 500 after it has been placed in the coronary sinus, as a separate step. Subsequently, the coronary sinus access catheter 500 is removed, leaving the G0 guide wire of .089 cm (.035 inch) in place. Second Stage: Catheter Introduction Guide Coronary Sinus / AIV access: As illustrated in Figures 14c-14d, the coronary sinus guide catheter 200 with the introducer liner 100 positioned within or through its lumen 202, is advanced over the GWX guidewire of .089 cm (. 035 inch) until the tip of the coronary sinus guide catheter 200 passes the "mouth" of the coronary sinus. The introducer liner 100 is then removed, leaving the coronary sinus guide catheter 200 in place, in the manner shown in Figure 14d. Third Stage: Introduction? Direction of Tissue Penetration Catheter: As illustrated in Figure 14e, the tissue penetration catheter 10 is then inserted over the pre-positioned .089 cm (.035 inch) GWX guidewire, through lumen 202 of the guide catheter of coronary sinus 200, and is advanced using fluoroscopy to a position close to the arterial block AB that is derived. The GW guidewire: .089 cm (.035 inch), then removed and removed from the first lumen 14 of the tissue penetration catheter 10 and an IVUS imaging catheter (not shown) then advanced through that first lumen 14, until the IVUS transducer resides within the image forming catheter receiver space of the orientation structure 36. The new IVUS catheter is used to receive a 360 degree ultrasound image from a vantage point in space interior of the orientation structure 36. This image allows the operator to see both the resident vessel (the GCV) and the target vessel (CX), as well as the reflections or artifacts of the three reinforcements 40, 42 and 44 of the structure orientation 36. Due to the disengagement fired between the reinforcing members 40, 42 and 44, the reflections or artifacts produced by the reinforcing members will form a generally "Y" structure image as illustrated in the Figures 2 and 3 of this patent application. The reflection 40Ref produced by the first reinforcing member 40, is clearly distinguished from the reflections 42Ref, 44Ref produced by the second and third reinforcing members 42, 43 and provides an indication of the particular direction where the needle member 30 travels when is advanced from the needle exit aperture 46 on the side of the catheter body 12. Thus, if the reflection of the first reinforcement member 40Ref observed in the IVUS image does not extend directly into or into the lumen of CX (as is illustrated in Figure 3, the operator will rotate the tissue penetration catheter 10 until the reflection of the first reinforcing member 40Ref observed in the IVUS image if it extends directly into or into the lumen of the CX "(as illustrated in FIG. Figure 2) This will ensure that the needle member 30 is properly directed to enter the CX when it is advanced Fourth Stage: Penetration Tract Formation Initial Arterio-venous to the Block: As illustrated in Figures 14f-14h, the tissue penetration needle member 30 is then advanced in the distal direction to its extended position so that it pierces through the resident vessel wall (GCV) through any tissue that may exist between the resident vessel (GCV) and the target vessel (the CX) and within the lumen of the target vessel (the CX) at a site downstream of the AB arterial block. This maneuver results in the formation of the initial arterio-venous penetrating tract PT. With the needle member 30 in its extended position and its distant tip in the lumen of the target vessel (the CX) a GW2 guide wire with a diameter of .035 cm (.014 inch) is inserted through the proximal gate 27 of the controller needle / hand piece of the tissue penetration catheter 15 and advanced through the lumen 31 of the needle member 30 into the target vessel (the CX) as illustrated in Figure 14h. After the .035 inch (.014 inch) diameter GW2 guide wire has been introduced into the target vessel (the LAD) the needle member 30 is retracted to its retracted position, leaving the guidewire GW2 with the diameter of. 035 cm (.014 inch) extending through the interstitial passage formed initially within the target vessel (CX) as illustrated in Figure 14h. Subsequently, the needle member 30 is withdrawn to its retracted position and the tissue penetration catheter 10 is withdrawn and removed leaving the .035 cm (.014 pμlgada) guidewire in place, i.e. extending to, through the blood tract. recently formed arterio-venous PT penetration (as illustrated in Figure 14h). Fifth Stage: Enlargement of the Tract of Penetration to form the Blood Flow Passage Arterio-venous: As illustrated in Figure 14i, the sub-selective liner 100 and its introducer 111 are advanced through the guide catheter 203 over the second guidewire GW2 to a site where the distal end of the sub-selective liner 100 is within the intermediate AIV adjacent to the distant PT penetration tract. Subsequently, the introducer 111 is removed and a catheter device for 'CEC channel enlargement of the type described in the US patent application. 09 / 056,589, advancement is made on the .035 cm (.014 inch) GW2 guidewire extending through the arterio-venous penetrating tract PT, thereby dilating or enlarging the tract to form a flow passage of arteriovenous blood PW. This stage of the procedure provides control over the diameter or size of the arteriovenous blood flow passages PW and assists in ensuring that the PW passages remain open and functional after the completion of the procedure. After this enlargement of the penetration tract to form the intended passage PW, the CEC channel enlargement catheter device is withdrawn and removed, leaving the sub-selective liner 100 and the second guidewire GW2 in place. Sixth Stage: Displacement Placement Connector in the Arterio-venous Blood Flow Passage: It may be convenient, in an optional step as illustrated in Figures 14j-14k, to place a connector device within the PW passageway. A catheter for the supply of a CDC connector device, of the type described in the patent application of the US. Serial No. 08 / 970,694, is advanced through the sub-selective liner 100 and over the .035 cm (.014 inch) GW2 guidewire extending through the arterio-venous passage PW, to implant a connector device CD inside that PW passage. The CDC connector delivery catheter device is then removed, and the sub-selective liner 100 and the .014 inch GW2 guidewire that has extended through the distant arteriovenous passageway PW then retracts to a position close to the PW passage. Seventh Stage: Deployment of Blocker in Lumen de Vena Next to Blockade: As illustrated in Figures 141 -14m, the guide wire GW2 is then removed and one or more embolic blocking members BM are introduced into the proximal end of the sub-selective liner 100, pushes through the lumen of the sub-selective liner 100 using a push rod (not shown) and ejects to the lumen of the large cardiac vein (GCV) close to the PW blood flow passage where this or these embolic blockers expand and attach to the vein wall, to cause substantial occlusion and blocking of blood flow through the vein in that site. Examples of these BM blocking members and their implanting methods are described in US patent application. Serial No. 09 / 117,516. The GWX wire with a diameter of .035 cm (.035 inch) is then removed and a BM embolic blocker member is inserted into the proximal end of the sub-selective liner. A push rod is then advanced through the lumen of the blocking delivery catheter, to push the embolic blocker member BM out of the distal end of the sub-selective liner and into its desired position in the coronary vein lumen (GCV). It will be noted that this blocker deployment step can be performed at that point in the procedure or it can be delayed at a later time in the process. This completes the procedure, and results in arterial blood flow from the circumflex artery (CX) through the arteriovenous PW passage, through the large GCV cardiac vein and anterior interventricular vein in the retrograde direction, in order to make perfusion of the myocardium that has become ischemic due to blockage of the left anterior descending coronary artery (LAD) as illustrated by the flow indicator arrows in Figure 14m. It will be understood and appreciated that the invention has been described herein with reference to certain currently preferred embodiments and examples only, and no effort has been made to exhaustively describe all possible embodiments and embodiments of the invention. Undoubtedly, as those skilled in the art will appreciate, various additions, deletions, modifications and variations may be made to the particular embodiments and examples previously described without departing from the intended spirit and scope of the invention. For example, when this patent application has listed the steps of a method or procedure in a specific order, it may be possible (or even desirable in certain circumstances) to change the order in which some stages are performed, and that the particular steps of the claims of the method or method set forth below are not considered as specific in order unless the specificity of order is expressly stated in the claim. Another example is that, although the specific procedures described in detail in this application involve penetrating through the tissue located within an "acceptable penetration zone", this acceptable penetration zone does not require to be occupied by tissues but rather this penetration zone acceptable may constitute all or part of an open space such as a body cavity or hollow. Accordingly, it is intended that all these additions, deletions, modifications and variations be included within the scope of the following claims.

Claims (55)

1. CLAIMS 1. A tissue penetration catheter device usable to penetrate outward from a lumen of a blood vessel where the catheter device is placed, through the wall of this blood vessel and to a target site, the device is characterized in that it comprises: i) a flexible catheter body that is inserted into the vein, the catheter body has a side wall, a proximal end, a distal end and an exit opening formed in its side wall; ii) a first lumen through which a separate image formation catheter can be inserted; iii) a second lumen extending through the exit opening; iv) a tissue penetrating member disposed within the second lumen and advancing out of the exit opening; and v) an orientation structure placed on the body of the catheter, the orientation structure having a) a space for receiving an image formation catheter there formed, in alignment with the first lumen and b) at least one marker member located on one side of catheter receptor image-forming space, the marker is at least placed and constructed to create an image display received from an image formation catheter positioned within the image-forming catheter receiver space, an indication of the route that will be followed by the tissue penetration member, as the tissue penetration member is advanced from the catheter body.
2. 2. The catheter device according to claim 1, characterized in that a guidewire lumen extends longitudinally through the tissue penetrating member.
3. 3. The catheter device according to claim 1, characterized in that the orientation structure comprises a plurality of longitudinally extending reinforcing members, at circumferentially spaced locations, with respect to the hollow outer space, a first of the reinforcing members being a ) located in a radial position that is aligned with the location of the tissue penetration member outlet opening and b) constructed to produce an ultrasound image that differs from the images produced by the one or the other of the reinforcing members, the first of the reinforcing members in this way is operative to create, in an image received through an IVUS catheter placed within the hollow interior space.
4. 4. The catheter device according to claim 1, characterized in that it further comprises: a distal tip member formed at the distal end of the orientation apparatus.
5. 5. The catheter device according to claim 4, characterized in that a lumen extends through the distal tip member in such a way that an image forming catheter can be advanced from the hollow interior space of the orientation structure, through the lumen of the distant tip member.
6. The catheter device according to claim 1, characterized in that the tissue penetrating member is resilient and has a distal portion that is preformed to a curved configuration, such that when the tissue penetrating member is in its The retracted position will adapt to the shape of the first lumen of the catheter body and when the tissue penetrating member is in its extended position, its distal position will acquire the curved configuration to which it was preformed.
7. The catheter device according to claim 6, characterized in that the distal portion of the tissue penetration member is preformed to a curved configuration having a radius of curvature.
8. 8. The catheter device according to claim 1, characterized in that the tissue penetrating member has a lancet-type bevel formed at its distal end.
9. 9. The catheter device according to claim 6, characterized in that it further comprises: a rigid tubular tissue penetrating member housing disposed within the second lumen, such that when the tissue penetrating member is in its retracted position, the distal tip of the tissue penetrating member will be placed inside the tissue member housing.
10. The catheter device according to claim 9, characterized in that the housing of the tissue penetration member is bent outwardly toward the exit length of the tissue penetration member.
11. The catheter device according to claim 10, characterized in that the catheter body is slightly bent to conform to the curvature of the housing of the tissue penetration member.
12. The catheter device according to claim 9, characterized in that a tubular liner is placed within the housing of the tubular tissue penetrating member.
13. 13. The catheter device according to claim 12, characterized in that the tubular liner is formed of plastic.
14. The catheter device according to claim 12, characterized in that the tubular liner comprises an inner lubricating layer, a medium structure layer 'and an outer adhesive layer.
15. The catheter device according to claim 12, characterized in that the tubular liner i extends out of and beyond any end of the housing of the tissue penetrating member.
16. 16. The catheter device according to claim 10, characterized in that a locator body is connected to the tubular tissue penetration member housing and positioned within the catheter body to stabilize the rotational orientation and position of the penetrating member housing of the catheter. tubular tissue.
17. The catheter device according to claim 11, characterized in that the additionally coupled surfaces are formed in the tissue penetrating member and the catheter body to prevent rotation of the tissue penetrating member relative to the catheter body.
18. 18. The catheter device according to claim 17, characterized in that the additionally coupled surfaces comprise a key formed in one of the tissue penetration member and the catheter body and a keyway formed in the other of the catheter body catheter, the The key is received within the keyway to prevent rotation of the tissue penetration member within the catheter body.
19. The catheter device according to claim 17, characterized in that the additionally coupled surfaces comprise a non-circular cross-sectional configuration of the tissue penetration member and a non-round cross-sectional configuration of at least a portion of the surrounding catheter the tissue penetrating member, such that the tissue penetrating member is prevented from rotating within the catheter body.
20. 20. A system for the creation of a penetration tract from the lumen of a coronary vein to the lumen of a coronary artery in a mammalian heart, having a coronary venous sinus, the system is characterized in that it comprises a device in accordance with the claim 1, in combination with: a coronary sinus guide catheter comprising a flexible catheter body having a proximal end, a distal end, a longitudinally extending lumen and a curvilinear segment formed near its distal end; the catheter device is passed through the lumen of the coronary sinus guide catheter and into the coronary vein.
21. The system according to claim 20, characterized in that the coronary sinus guide catheter further comprises: a hemostatic valve associated with the guide catheter lumen, the hemostatic valve is constructed to allow the catheter device to pass and the hemostatic valve is operative to i) prevent blood from flowing in the opposite direction of the coronary sinus guide catheter lumen, when the catheter device is not inserted through, and ii) forms a seal with respect to the catheter device when the catheter device is inserted through the lumen of the guide catheter to prevent blood from flowing in the opposite direction.
22. 22. The system according to claim 20, characterized in that it further comprises: a tubular introducer liner having a tapered distal end and a lumen extending longitudinally through; the introducer liner is passed through the lumen of the coronary sinus guide catheter and into the coronary vein; and the catheter device is inserted through the lumen of the introducer liner and into the coronary vein, distant to the distal end of the introducer liner.
23. 23. A tissue penetration catheter device that is placed in the lumen of a blood vessel and used to form a penetrating tract that extends from the lumen of the blood vessel, through the wall of that blood vessel, through a predetermined acceptable penetration zone and towards an objective location within the patient's body, the catheter device is characterized in that it comprises: i) a flexible catheter body that is insertable in a blood vessel, the catheter body has a proximal end, a distal end, and an exit opening; ii) a lumen extending through the exit opening; iii) a tissue penetration member positioned within the lumen, the tissue penetration member is dimensioned and configured such that when sufficiently oriented and stabilized, it will advance out of the exit gate through the wall of the blood vessel, through the zone and acceptable penetration and towards the target location; iv) a stabilizer that is configured to prevent the tissue penetration member from deviating from the acceptable penetration zone as it is advanced to the target site.
24. 24. The catheter device according to claim 23, characterized in that the guidewire lumen extends longitudinally through the tissue penetrating member.
25. 25. The catheter device according to claim 23, characterized in that the stabilizer is selected from the group of stabilizers consisting of: coupling member for frictionally coupling between the tissue penetrating member and the catheter body; bushings placed within the lumen that restrict the tissue penetration member to prevent its side-to-side movement; a region of reduced diameter of the lumen which restrains the tissue penetrating member to prevent its side-to-side movement; at least one magneto creating a magnetic that prevents side-to-side movement of the tissue penetration member; and a member that deploys laterally from the catheter adjacent to the exit opening, to prevent side-to-side movement of the tissue penetration member when advancing from the catheter.
26. 26. The catheter device according to claim 23, characterized in that the stabilizer comprises: a penetration member housing of rigid tubular tissue pooned within the second lumen, such that when the tissue penetrating member is in its poon When retracted, the distal tip of the tissue penetration member will be placed within the housing of the tissue penetration member.
27. 27. The catheter device according to claim 26, characterized in that the housing of the tissue penetrating member is bent out toward the exit opening of the tissue penetrating member.
28. 28. The catheter device according to claim 27, characterized in that the catheter body is slightly bent to adapt to the curvature of the housing of the tissue penetration member.
29. 29. The catheter device according to claim 26, characterized in that a tubular liner is placed within the housing of the tubular tissue penetrating member.
30. 30. The catheter device according to claim 29, characterized in that the tubular liner is formed of plastic.
31. 31. The catheter device according to claim 29, characterized in that the tubular liner comprises an inner lubricating layer, a middle layer and an outer adhesive layer.
32. 32. The catheter device according to claim 29, characterized in that the tubular liner extends outwardly from and beyond any end of the housing of the tubular tissue penetrating member.
33. 33. The catheter device according to claim 31, characterized in that a destabilizing body is connected to the housing of the tubular tissue penetrating member and pooned within the catheter body, to stabilize the rotational orientation and poon of the penetrating member housing. of tubular fabric.
34. 34. The catheter device according to claim 23, characterized in that the tissue penetrating member is bent so that rotation of the tissue penetrating member while advancing from the catheter will cause the penetrating member of the catheter to penetrate. tissue deviates from the acceptable penetration zone and wherein the stabilizer comprises frictionally coupled surfaces formed in the tissue penetrating member and the catheter body, to prevent rotation of the tissue penetrating member relative to the catheter body.
35. 35. The catheter device according to claim 34, characterized in that the frictionally coupled surfaces comprise a head formed in one of the tissue penetrating member and the catheter body and a keyway formed in the other of the catheter of the catheter body, the key is received within the keyway to prevent rotation of the tissue penetration member within the catheter body.
36. 36. The catheter device according to claim 34, characterized in that the frictionally coupled surfaces comprise the lateral surface of a tissue penetration member of non-round cross-sectional configuration and a corresponding non-circular cross-sectional configuration of at least a portion of the catheter surrounding the tissue penetrating member, in such a way that the tissue penetration member is prevented from rotating inside the catheter body,
37. 37. The catheter device according to claim 23, characterized in that the stabilizer comprises a laterally deployable member adjacent to the outlet gate, the laterally deployable member is initially placed in a stored position, whereby it is substantially non-projecting from the catheter and is subsequently deployed to a laterally extended position where it holds the tissue penetrating member and prevents the tissue penetrating member from being displaced. deviate from the zo of acceptable penetration as it progresses.
38. 38. The catheter device according to claim 1, characterized in that it further comprises a deployable member laterally adjacent the exit gate, the laterally deployable member is initially placed in a stored position where it is substantially non-projecting from the catheter and subsequently deployed to a laterally extended position where it supports the tissue penetration member and prevents the tissue penetration member from deviating from the acceptable penetration zone as it is advanced.
39. 39. The catheter according to claim 1, characterized in that it further comprises a rotational locking or latching apparatus for preventing at least a portion of the tissue penetrating member from rotating inside the catheter while the tissue penetrating member is in its position retracted
40. 40. The catheter according to claim 23, characterized in that it further comprises a rotational locking apparatus for preventing at least a portion of the tissue penetrating member from rotating within the catheter while the tissue penetrating member is in its retracted position .
41. 41. The catheter device according to claim 40, characterized in that the rotational locking apparatus comprises a first member formed in the body of the catheter and a second member formed in the tissue penetration member, such that when the member of tissue penetration is in its retracted position, the first and second members frictionally engage each other to prevent rotation of at least a portion of the tissue penetration member that is distant to the second member.
42. 42. A catheter system for forming a penetrating tract from the lumen of a coronary blood vessel of a mammalian patient to an objective site within the patient's body, the catheter system being characterized in that it comprises: a) a guide catheter coronary sinus having a distal end, the coronary sinus guide catheter is configured to advance transluminally through the patient's venous vasculature until its distant end is placed in the patient's coronary venous sinus; b) a tissue penetration catheter that is inserted through the coronary sinus guide catheter lumen, the tissue penetration catheter comprises: i) a flexible catheter body having a proximal end and a distal end and a gate exit formed on one side; ii) a lumen extending through the exit gate; and iii) a tissue penetration member positioned within the lumen and advancing out of the exit gate; c) a sub-selective liner comprising a tube having a lumen and a distal end, the tube is sized to advance through the lumen of the coronary sinus guide catheter.
43. 43. The system according to claim 42, characterized in that it further comprises a coronary sinus guide introducer having a tapered distal portion and a guidewire lumen extending longitudinally through, the coronary sinus guide introducer is inserted through the lumen of the coronary sinus guide catheter, such that its tapered distal portion projects beyond and beyond the distal end of the coronary sinus guide catheter.
44. 44. The system according to claim 42, characterized in that it further comprises: a sub-selective liner introducer having a tapered distal portion and a longitudinally extending guidewire lumen, the sub-selective liner introducer is inserted. through the lumen of the sub-selective liner, such that its tapered distal portion projects out of and beyond the distal end of the sub-selective liner.
45. 45. A method for performing percutaneous coronary in situ venous arterialization, the method is characterized in that it comprises: A) providing a catheter system that includes: i) a coronary sinus guide catheter having a distal end, the sinus guide catheter coronary is configured to advance transluminally through the patient's venous vasculature, until its distant end is placed in the patient's coronary venous sinus; ii) a tissue penetration catheter comprising a) a flexible catheter body having a proximal end, a distal end and an exit gate that is fortified on one side; d) a lumen extending through the exit gate; and e) a tissue penetrating member having a lumen extending longitudinally through, the tissue penetrating member is placed inside the lumen and advanced outside the exit gate; iii) a sub-selective liner having a distal end and a lumen extending longitudinally through, the liner is sized to advance through the lumen of the coronary sinus guide catheter; B) inserting a first guide wire having a proximal end and a distal end, such that the distal end of the first guide wire is in the coronary venous vasculature and its proximal end is outside the patient's body; C) advancing the coronary sinus guide catheter over the first guide wire to a position where the distal end of the coronary sinus guide catheter is within the coronary sinus; D) advancing the tissue penetration catheter through the lumen of the coronary sinus guide catheter and over the first guidewire, to a position within a coronary vein; E) rotationally orienting the tissue penetration catheter to orient the tissue penetrating member at a site within the lumen of an artery; F) advancing the tissue penetration member from the catheter to form a penetrating tract through a predetermined acceptable penetration zone, including penetration through the wall of the vein and the wall of an artery, such that the distal end of the tissue penetration member is in the lumen of the artery; G) passing a second guidewire through the lumen of the tissue penetrating member and into the lumen of the artery; H) retracting the tissue penetration member within the tissue penetration catheter and removing the tissue penetration catheter, leaving the second guide wire in place; I) subsequently, advance the sub-selective lining through the lumen of the coronary sinus guide catheter and over the second guidewire, to a position where the distant end of the sub-selective liner is located within the vein adjacent to the tract penetration formed in step F; J) provide a tract enlargement catheter, advance the traction ligation catheter through the sub-selective lining and use the tract enlargement catheter to enlarge the penetration tract formed in step F, to create a passage of flow of blood between the vein and the artery, K) remove the tract enlargement catheter, leaving the sub-selective lining and the second guidewire in place; L) provide a connector supply catheter and a connector that is deployed in the blood flow passage, to maintain the blood flow passage after completing the operating procedure and to pass the connector supply catheter through the sub liner -selective and supply the connector in the blood flow passage; M) removing the connector supply catheter leaving the sub-selective liner and the second guidewire in situ; N) retracting the sub-selective liner to a location within the vein that is close to the location of the blood flow passage; O) remove the second guidewire; P) supplying through the sub-selective lining a blocking member, to block the lumen of the vein close to the location of the blood flow passage; and Q remove the sub-selective lining and the coronary sinus guide catheter.
46. 46. The method according to claim 45, characterized in that the catheter system provided in step A further comprises: a coronary sinus guide introducer having a tapered distal portion and a longitudinally extending guidewire lumen, the coronary sinus guide introducer is inserted through the lumen of the coronary sinus guide catheter, such that its tapered distal portion projects out of and beyond the distal end of the coronary sinus guide catheter; and wherein step C) comprises: placing the coronary sinus guide introducer through the lumen of the coronary sinus guide catheter, such that at least past its tapered distal portion projects out of the distal end of the guide catheter; inserting the proximal end of the first guidewire into the guiding wire lumen of the coronary sinus guide introducer and advancing the coronary sinus guide catheter and the coronary sinus guide introducer onto the first guide wire, until the distal end of the guiding catheter coronary sinus is in the coronary sinus; and removing the coronary sinus guide introducer leaving the coronary sinus guide catheter and the first guidewire in place.
47. 47. A method according to claim 45, characterized in that the catheter system provided in step A further comprises: a sub-selective liner introducer having a tapered distal portion and a guidewire lumen extending longitudinally through, the sub-selective liner introducer is inserted through the lumen of the sub-selective liner, such that its tapered distal portion projects out of and beyond the distal end of the sub-selective liner; and wherein step G comprises: placing the sub-selective liner introducer through the lumen of the sub-selective liner, such that at least part of its tapered distal portion projects out of the distal end of the sub-selective liner; Insert the proximal end of the second guidewire into the guidewire lumen of the sub-selective liner and advance the sub-selective liner and the sub-selective liner over the first guidewire until the distal end of the sub-selective liner selective is placed in the coronary vein adjacent to the penetration tract; and removing the sub-selective liner introducer leaving the sub-selective liner and the second guidewire in place.
48. 48. The method according to claim 45, characterized in that step G is eliminated and the tract enlargement catheter of step G is advanced in position and used without sub-selective lining.
49. 49. The method according to claim 45, characterized in that steps I and J comprise: I. removing the tract enlargement catheter and the sub-selective liner, leaving the second guide wire in place; J. Providing a connector delivery catheter and a connector that is deployed in the blood flow passage to maintain the blood flow passage after completing the operating procedure, advancing the connector delivery catheter over the second guide wire and Supply the connector in the blood flow passage.
50. 50. The method according to claim 45, characterized in that the tissue penetration catheter provided in step A further comprises: an image forming catheter lumen through which the separate image formation catheter can be inserted; and an orientation structure positioned on the catheter body, the orientation structure has an image formation catheter receiver space there formed in alignment with the first lumen and at least one marker member located on one side of the catheter receiver space of image formation, where the marker. at least one is placed and constructed to create in an image display received from an image forming catheter positioned within the image forming catheter receiver space, an indication and wherein stage E comprises: inserting an image forming catheter through the image-forming catheter lumen and within the image-forming catheter receiver space; using the image forming catheter to image the target location within the artery; rotating the tissue penetration catheter as necessary to cause indication of the path that will follow the tissue penetration member, as the tissue penetration member is advanced from the body of the catheter to indicate that the penetrating member of the catheter tissue pass into the target location within the artery.
51. 51. The method according to claim 45, characterized in that the tissue penetration catheter provided in the lid A further comprises: a stabilizer which is configured to prevent the tissue penetration member from deviating from the acceptable penetration zone as it is advanced to the target site; and wherein step F comprises: advancing the tissue penetration member while using the stabilizer to prevent the tissue penetration member from deviating from the acceptable penetration zone, thereby forming a penetration tract through the tissue. acceptable penetration zone including penetration through the wall of the vein and artery wall, such that the distal end of the tissue penetration member is in the lumen of the artery.
52. 52. Method for performing a percutaneous coronary artery bypass, the method is characterized in that it comprises: AA) providing a catheter system that includes: i) a coronary sinus guide catheter having a distal end, the coronary sinus guide catheter is it is configured to advance transluminally through the patient's venous vasculature, until its distant end is placed in the patient's coronary venous sinus; ii) a tissue penetration catheter comprising a) the flexible catheter body having a proximal end, a distal end and an exit gate formed on one side; b) a lumen extending through the exit gate; and c) a tissue penetrating member having a lumen extending longitudinally through, the tissue penetrating member is positioned within the lumen and advanced outside the exit gate; iii) a sub-selective liner having a distal end and a lumen extending longitudinally through, the liner is sized to advance through the lumen of the coronary sinus guide catheter; AB) inserting a first guidewire having a proximal end and a distal end into the patient, such that the distal end of the first guidewire is in the coronary venous vasculature and its proximal end is outside the patient's body; AC) advancing the coronary sinus guide catheter over the first guide wire to a position where the distal end of the coronary sinus guide catheter is within the coronary sinus; AD) advancing the tissue penetration catheter through the lumen of the coronary sinus guide catheter and over the first guidewire, to a first position within a coronary vein; AE) rotationally orienting the tissue penetration catheter, to direct the tissue penetration member to a first objective orientation within the lumen of an artery; AF) advancing the tissue penetration member from the catheter to form a first penetration tract distant from the obstruction, the first penetration tract extending through a predetermined acceptable penetration zone including penetration through the wall the vein and artery wall, such that the distal end of the tissue penetration member enters the lumen of the artery; AG) passing a second guidewire through the lumen of the tissue penetrating member and into the lumen of the artery; AH) retracting the tissue penetration member to the tissue penetration catheter and removing the tissue penetration catheter, leaving the second guide wire in situ; AI) advancing the sub-selective liner on the first guide wire to a site that is distant to the first penetration tract formed in the AF stage; AJ) supplying through the sub-selective lining a blocking member to block the lumen of the vein distant to the first penetration tract; AK) remove the sub-selective liner leaving the first guide wire in situ; AL) advancing the tissue penetration catheter through the lumen of the coronary sinus guide catheter and over the first guidewire, to a second position within a coronary vein; AM) rotationally orienting the tissue penetration catheter to direct the tissue penetrating member to a second target site within the lumen of an artery; AN) advancing the tissue penetration member from the catheter to form a second penetration tract close to the obstruction and the second penetration tract extends through a predetermined acceptable penetration zone, which includes penetration through the wall of penetration. the vein and artery wall, such that the distal end of the tissue penetration member enters the lumen of the artery; AO) passing a third guidewire through the lumen of the tissue penetrating member and into the lumen of the artery; AP) retract the tissue penetration member into the tissue penetration catheter and remove the tissue penetration catheter, leaving the third guidewire in place; AQ) advancing the sub-selective lining through the lumen of the coronary sinus guide catheter and over the second guidewire to a position where the distal end of the sub-selective liner is located within the vein adjacent to the first penetrating tract formed in the AF stage; AR) provide a tract enlargement catheter, advance the tract enlargement catheter through the sub-selective lining and use the tract enlargement catheter to enlarge the first penetration tract formed in the AS stage to create a flow passage of blood between the vein and the artery distant from the obstruction; AS) remove the tract enlargement catheter, leaving the sub-selective liner and second guide wire in situ; AT) provide a connector supply catheter and a connector that is deployed from the blood flow passage, to maintain the blood flow passage after completing the operating procedure and to pass the connector supply catheter through the sub liner. -selective and supply the connector to the blood flow passage; AU) remove the connector supply catheter, sub-selective liner and second guidewire; AV) advancing the sub-selective lining through the lumen of the coronary sinus guide catheter and over the third guide wire to a position where the distal end of the sub-selective liner is located within the vein adjacent to the second penetrating tract formed in the AN stage; AW) provide a tract enlargement catheter, advance the tract enlargement catheter through the sub-selective lining and use the tract enlargement catheter to enlarge the second penetration tract formed in the AN stage, to create a passage of near blood flow between the vein and artery close to the obstruction; AX) remove the tract enlargement catheter, leaving the sub-selective liner and the third guidewire in situ; AY) provide a connector supply catheter and a connector that is deployed in the proximal blood flow passage to maintain the blood flow passage after completing the operative procedure and passing the connector supply catheter through the sub liner -selective and supply the connector to the next blood flow passage; AZ) remove the connector supply catheter; BA) retracting the sub-selective lining to a site within the vein that is close to the site of the blood flow passage; BB) removing the third guidewire; BC) supplying through the sub-selective liner a blocking member for the lumen of the vein proximate the location of the proximal blood flow passage; and BD) remove the sub-selective lining and coronary sinus guide catheter.
53. 53. • A method according to claim 52, characterized in that the catheter system provided in step AA further comprises: a coronary sinus guide introducer having a tapered distal portion and a longitudinally extending guidewire lumen, the coronary sinus guide introducer is insertable through the lumen of the coronary sinus guide catheter, such that its tapered distal portion projects out of and beyond the distal end of the coronary sinus guide catheter; wherein step H comprises: placing the coronary sinus guide introducer through the lumen of the coronary sinus guide catheter I, such that at least part of its tapered distal portion projects out of the distal end of the guide catheter; inserting the proximal end of the first guide wire into the guidewire lumen of the coronary sinus guide introducer and advancing the coronary sinus guide catheter and coronary sinus guide introducer over the first guidewire, until the distal end of the sinus guide catheter coronary is in the coronary sinus; and removing the coronary sinus guide introducer leaving the coronary sinus guide catheter and first guidewire in place.
54. 54. The method according to claim 52, characterized in that the catheter system provided in step AA further comprises: a sub-selective liner introducer t having a tapered distal portion and a longitudinally extending guidewire lumen. , the sub-selective liner introducer is inserted through the lumen of the sub-selective liner, such that its tapered distal portion projects out of and beyond the distant end of the sub-selective liner.; wherein the step AQ comprises: placing the sub-selective liner introducer through the lumen of the sub-selective liner, such that at least part of its tapered distal portion projects out of the distal end of the sub-selective liner; Insert the proximal end of the second guidewire into the guidewire lumen of the sub-selective liner and advance the sub-selective liner and sub-selective liner over the first guidewire until the distant end of the sub-selective liner it is placed in the coronary vein adjacent to the first penetration tract formed in the AF stage; and removing the sub-selective liner introducer leaving the sub-selective liner and the second guide wire in place; and wherein step AK comprises: placing the sub-selective liner introducer through the lumen of the sub-selective liner, such that at least part of its tapered distal portion projects out of the distant end of sub-selective lining; Insert the proximal end of the third guidewire into the guidewire lumen of the sub-selective liner and advance the sub-selective liner and sub-selective liner over the first guidewire, until the far end of the liner sub -selective is placed in the coronary vein adjacent to the second penetration tract formed in the AN stage; and removing the sub-selective liner introducer leaving the sub-selective liner and third guide wire in place.
55. 55. A method according to claim 52, characterized in that the stages AQ and AV are eliminated and the tract enlargement catheter of the stages AR and AW is advanced in position and used without the sub-selective lining.