MX2007001753A - Drug delivery in the coronary sinus - Google Patents

Abstract

A method for delivering a therapeutic substance in a coronary sinus (28)of a patient includes inserting a catheter (30) through a vein (22) into a right atrium (26) of the patient, and advancing the catheter from the right atrium into the coronary sinus. A resilient anchor (34), which is fixed to the catheter, is released so as to anchor the catheter in the coronary sinus without blocking blood flow through the coronary sinus. The therapeutic substance is then administered from the catheter into the coronary sinus.

Description

ADMINISTRATION OF PHARMACY IN THE CORONARY SINE RECIPROCAL REFERENCE TO RELATED REQUEST This application claims the benefit of the U.S. Provisional Patent Application. 60/601, 068, filed August 12, 2004, which is incorporated herein by reference.

BACKGROUND OF THE INVENTION Methods and devices for administration of drugs in the coronary sinus are known in the art. Such methods and devices are described, for example, in the following US Patents: US 6,416,493, US 4,927,412, US 5,487,730 and US 6,709,415, the descriptions of which are incorporated herein by reference. All the devices described in these patents are designed for short-term use, such as for retrograde perfusion of a solution for cardioplegia during cardiac surgery.

BRIEF DESCRIPTION OF THE INVENTION The embodiments of the present invention provide catheters and anchoring mechanisms for such catheters that can be used to administer therapeutic substances within the coronary sinus for extended periods, typically over the course of many hours or even days. The fixation mechanism holds the catheter securely in place within the coronary sinus, generally without substantially blocking the venous flow through the coronary sinus into the right atrium and without significant trauma to the coronary sinus or other anatomical structures. In the embodiments described below in the present invention, the catheter is securely fixed regardless of the blood flow and the broad shape of the coronary sinus leading to the right atrium. The catheter can then be used to administer therapeutic substances in the coronary sinus. This arrangement is particularly useful, for example, in cell therapy, as well as in other cardiac drug treatments. Therefore, a method for administering a therapeutic substance in a coronary sinus of a patient is provided, in accordance with one embodiment of the present invention, including: inserting a catheter through a vein into a patient's right atrium, and advancing the catheter from the right atrium to the coronary sinus; releasing a resilient anchor, which is fixed to the catheter, so that it anchors the catheter in the coronary sinus without blocking the blood flow through the coronary sinus; and administering the therapeutic substance from the catheter in the coronary sinus. Also provided, in accordance with one embodiment of the present invention, is a method of administering a therapeutic substance in a coronary sinus of a patient, including: providing a catheter including a distal end that includes multiple parallel sheets formed from a collapsible material; which encloses the catheter inside a flexible cover; while the catheter is enclosed within the flexible cover, insert the catheter and cover through a vein into the right atrium of the patient, and advance the catheter and cover from the right atrium to the coronary sinus; moving the catheter distally relative to the cover so that the parallel sheets are released from the cover and causes the sheets to fold outwardly so that the sheets anchor the catheter in the coronary sinus; and administering the therapeutic substance from the catheter in the coronary sinus. Additionally, a method for administering a therapeutic substance in a coronary sinus of a patient is provided, in accordance with one embodiment of the present invention, including: inserting a catheter through a vein into a patient's right atrium, and advancing the catheter from the right atrium to the coronary sinus; inflating one or more balloons, which are fixed to the catheter, so that it anchors the catheter in the coronary sinus without blocking the blood flow through the coronary sinus; and administering the therapeutic substance from the catheter in the coronary sinus. Further provided, in accordance with one embodiment of the present invention, is a method of administering a therapeutic substance in a coronary sinus of a patient, including: implanting a stent into the coronary sinus; inserting a catheter through a vein into a right atrium of the patient, and advancing the catheter from the right atrium to the coronary sinus; releasing an anchor, which is fixed to the catheter, so that the catheter is anchored to the stent; and administering the therapeutic substance from the catheter in the coronary sinus. In addition, an apparatus for administering a therapeutic substance in a coronary sinus of a patient is provided, in accordance with one embodiment of the present invention, including: a catheter, which is adapted to be inserted through a patient's blood vessel into the coronary sinus, and which has a lumen for the administration of the therapeutic substance through it to the coronary sinus; and a resilient anchor, which is fixed to the catheter, so that it anchors the catheter in the coronary sinus without blocking the blood flow through the coronary sinus. In some embodiments, the catheter has a distal end and a channel, and the resilient anchor includes at least one resilient wire, which is arranged to pass through the channel so that it protrudes from the distal end of the catheter and engages a wall of the blood vessel. In one embodiment, the catheter has at least one first and second channels, and the at least one resilient wire includes at least one first and second wires, which are arranged to pass respectively through the first and second channels in a manner that meshes the blood vessel wall in two or more locations on different sides of the catheter. In some embodiments, the at least one resilient wire includes a shape memory material, which is held straight within the channel and is pre-formed to bend toward a predetermined shape after protruding from the distal end so as to engage the wall of the blood vessel. Typically, the predetermined shape includes at least one of a handle shape, a spiral and a zigzag shape. Additionally or alternatively, the predetermined shape includes a fold, and wherein the at least one resilient wire is adapted to be folded from the catheter into a blood vessel that connects the coronary sinus and engages the wall of the lateral blood vessel. In a described embodiment, the channel has multiple exit orifices at different locations along the distal end of the catheter, and is arranged to allow an operator of the apparatus to choose one of the exit orifices, and advance the at least one wire resilient through the chosen outlet orifice so as to mesh the wall of the blood vessel in a desired location. In some embodiments, the channel has a proximal inlet, and the at least one resilient wire has a proximal end and includes a handle, which is fixed to the proximal end of the at least one resilient wire for use by an operator of the apparatus that manipulates the wire in the channel, so that the handle engages the proximal channel inlet when the at least one resilient wire extends completely from the distal end of the catheter. Additionally or alternatively, the catheter includes a locking mechanism for securing the at least one resilient wire in place at the proximal end of the channel after the at least one resilient wire has engaged the wall of the blood vessel so as to prevent the Relative axial movement between the catheter and the at least one resilient wire. The locking mechanism may include a spring clip, which is arranged to press against the at least one resilient wire, or a set screw, which is arranged to engage the at least one resilient wire within the channel. In other embodiments, the catheter includes a flexible stent, which is arranged to enclose the catheter while containing the resilient anchor, and to be advanced with the catheter through the blood vessel, wherein the flexible cover is adapted to allow that the catheter is changed distally in relation to the cover so that the anchor is released, causing the anchor to mesh a wall of the blood vessel. In some of these embodiments, the anchor includes one or more resilient wires, which are pre-formed so that they spring outward in a predetermined manner when released from the cover. Typically, the predetermined shape includes at least one of a spiral shape, a handle and a hook. Additionally or alternatively, the catheter includes a distal end, which includes multiple parallel sheets formed from a resilient material, and which serves as the resilient anchor, such that after moving the catheter distally in relation to the cover, the plates bend outward and mesh the wall of the coronary sinus. Typically, the sheets are arranged, after bending outwardly, to block at least in part the blood flow through the coronary sinus, in a described manner, the sheets are constructed so that they deform in response to excessive blood pressure in the coronary sinus, thus allowing blood to flow out of the coronary sinus. In another embodiment, the resilient anchor is arranged to anchor the catheter when engaging a stent implanted in the coronary sinus. Further provided, in accordance with one embodiment of the present invention, is an apparatus for administering a therapeutic substance in a coronary sinus of a patient, including: a catheter, which is adapted to be inserted through a patient's blood vessel to the coronary sinus, and which has a lumen for the administration of the therapeutic substance through it to the coronary sinus, and which includes a distal end including multiple parallel sheets formed from a collapsible material; and a flexible stent, which is arranged to enclose the catheter so as to contain the flexible sheets, and to advance with the catheter through a blood vessel to the coronary sinus, wherein the flexible cover is adapted to allow the The catheter moves distally relative to the cover so that it releases the parallel sheets from the cover and causes the sheets to fold outwardly so that the sheets anchor the catheter in the coronary sinus. In one embodiment, the sheets are adapted to fold out under a pressure of blood flow in the coronary sinus. In another embodiment, the apparatus includes a balloon at the distal end of the catheter, which is inflatable so as to push the sheets outwardly. Typically, the sheets are arranged, after bending out, to at least partially block blood flow through the coronary sinus. Also provided, according to one embodiment of the present invention, is an apparatus for administering a therapeutic substance in a coronary sinus of a patient, including: a catheter, which is adapted to be inserted through a patient's blood vessel to the coronary sinus, and which has a lumen for the administration of the therapeutic substance through it to the coronary sinus; and one or more balloons, which are attached to the catheter, and which are inflatable so as to anchor the catheter in the coronary sinus without blocking blood flow through the coronary sinus. The apparatus may include at least one additional balloon, which is fixed to the catheter and is inflatable so as to adjustably lock blood flow through the coronary sinus while the catheter is anchored in the coronary sinus. Additionally, an apparatus for administering a therapeutic substance in a coronary sinus of a patient is provided, in accordance with an embodiment of the present invention, including: a stent, which is adapted to be implanted within the coronary sinus; a catheter, which is adapted to be inserted through a blood vessel of the patient towards the coronary sinus, and which has a lumen for the administration of the therapeutic substance through it to the coronary sinus; and an anchor, which is fixed to the catheter, and arranged to anchor the catheter to the stent.

In one embodiment, the stent contains a shrunken opening, and the catheter includes a distal end that is adapted to pass through the shrunken opening in the stent, and the anchor includes a balloon, which is attached to the distal end of the catheter and it is arranged to be inflated after the distal end of the catheter has passed through the shrunken opening. Alternatively or additionally, the anchor includes one or more wires, which are arranged to advance from the distal end of the catheter so that the stent engages, and the catheter is arranged to advance distally along the wires to a position in the stent The present invention will be more fully understood from the following detailed description of the modalities, taken together with the drawings in which: BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic, cutaway view of a heart into which a catheter is inserted, in accordance with an embodiment of the present invention; Figure 2 is a detailed schematic view of the distal end of a catheter within the coronary sinus, in accordance with an embodiment of the present invention; Figures 3-6 are detailed schematic views of the distal ends of the catheters, in accordance with alternative embodiments of the present invention; Figure 7 is a schematic, pictorial illustration showing an arrangement for manipulating a wire at the proximal end of a catheter, in accordance with an embodiment of the present invention; Figures 8A and 8B are schematic, pictorial illustrations showing an arrangement for attaching a wire to the proximal end of a catheter in accordance with another embodiment of the present invention; Figure 9 is a schematic, pictorial illustration showing an arrangement for securing the position of a wire within a channel in a catheter, in accordance with a further embodiment of the present invention; Figures 10A and 10B are illustrations in sections of the catheter shown in Figure 9, taken along the line marked X-X in Figure 9; Figures 11 A and 11 B are schematic, side views of a catheter within the coronary sinus, illustrating a method for anchoring the distal end of the catheter, in accordance with another embodiment of the present invention; Figure 12A is a schematic side view of a catheter in the coronary sinus, illustrating another method for anchoring the distal end of the catheter, in accordance with an alternative embodiment of the present invention; Figure 12B is a schematic, sectional view of the catheter shown in Figure 12A, taken along the line marked X11 B-X11 B; Figures 12C and 12D are schematic views, in sections of the distal end of a catheter, in accordance with alternative embodiments of the present invention; Figures 13A and 13B are schematic side views of the distal end of a catheter, in accordance with another embodiment of the present invention; and Figure 14 is a schematic side view of a coronary sinus catheter, illustrating even another method for anchoring the distal end of the catheter, in accordance with one embodiment of the present invention.

DETAILED DESCRIPTION OF THE MODALITIES Figure 1 is a schematic view, cut away from a heart 20, having a coronary sinus 28 into which a catheter 30 is inserted, in accordance with an embodiment of the present invention. The catheter in this mode is inserted percutaneously, typically via the jugular vein, into the superior vena cava 22 and therefore into the right atrium 26. Alternatively, the catheter can be inserted into the right atrium through other routes, as is known in the art, such as through the femoral vein and the inferior vena cava 24. The distal end of the catheter is manipulated within the coronary sinus 28, and then anchored in place using methods and anchoring mechanisms such as those described in FIG. following the present invention. Figure 2 is a detailed schematic view of a distal end 32 of the catheter 30 within the coronary sinus., in accordance with one embodiment of the present invention. Two anchoring wires 34 protrude through the respective channels 36. Although in the embodiments illustrated in this patent application, the channels 36 are contained within the body of the catheter, these channels may alternatively be attached externally to the catheter tube. . In addition, although each of the figures in this patent application shows a certain number of anchoring elements (such as two wires 34 in Figure 2), it will be understood that the principles of these anchoring mechanisms can be implemented using large or small numbers. of anchoring elements in each case. The anchor wires 34 comprise a biocompatible resilient material, typically a shape memory material, such as Nitinol. During the insertion of the catheter through the venous system and into the coronary sinus 28, the wires 34 are contained within the channels 36 and do not protrude out of the distal end 32. The wires extend all the way through the catheter 30 and are accessible at the proximal end of the catheter. Once the distal end of the catheter 30 has been properly located in the coronary sinus, the wires 34 are pushed forward from the proximal end, and therefore are caused to advance out of the distal end of the channels 36. The wires are pre-molded so that when they are released from the confines of the narrow channels, the wires are folded outward, as shown in Figure 2, and meshes the wall of the coronary sinus. The force of the gear is suitable to anchor the catheter 30 in place so as to support the flow of blood from the coronary veins via the sinus 28 to the atrium 26, without causing injury or significant trauma to the coronary sinus wall. Despite partial obstruction of sinus 28 by catheter 30, blood from coronary veins is still able to flow past the catheter into atrium 26. While catheter 30 is still anchored in place, it is injected a therapeutic substance, such as a drug or a means for cell therapy, within the coronary sinus through a lumen 38 in the catheter 30. Alternatively, the therapeutic substances may be pre-loaded into a suitable reservoir at the distal end 32 of the catheter 30, and then release from the reservoir when the catheter is anchored in place. Typically, the therapeutic substance is released in a gradual, continuous dose, or alternatively, in a sequence of individual doses that are spaced over time. The catheter 30 does not need to be removed from the heart during the period of treatment. After the end of the treatment, the wires 34 are retracted in the proximal direction through the channels 36, and the catheter 30 is removed from the body.

Figure 3 is a detailed schematic view of the distal end of another catheter 40, in accordance with an alternative embodiment of the present invention. In this case, a resilient wire 42 is pre-molded so as to form a handle, a zigzag or spiral shape when advancing distally out of the channel 36. The pre-formed shape is slightly longer in transverse dimension than the diameter of the coronary sinus 28 in the white location of the catheter. As a result, the wire 42 engages the wall of the coronary sinus 28 and thus anchors the catheter in place. Figure 4 is a detailed schematic view of the distal end of a catheter 50, in accordance with even another embodiment of the present invention. The anchors 54 are fixed externally to the distal end of the catheter 50. As in the preceding embodiments, the anchors comprise resilient wires. During insertion through the vasculature and into the heart, the catheter 50 is contained within a flexible stent 52. The anchors 54 are thus contained and held within the cover, against the sides of the catheter 50. Once the distal end of the cover 52 has reached the coronary sinus, the catheter 50 changes in relation to the cover in the distal direction (by advancing the catheter and / or removing the cover), so that the distal end of the catheter protrudes outside the distal end of the cover within the coronary sinus. The anchors 54 are pre-molded so that when they are released from the cover 52, the wires jump outward and engage the wall of the coronary sinus. The cover 52 can then be completely removed from the body, or alternatively left in place during the treatment. In order to remove the catheter 50 from the coronary sinus, the cover 52 advances distally over the distal end of the catheter, thereby grouping the anchors 54 back into the cover and releasing the catheter. The cover, with the catheter and the anchors kept inside, is then removed from the body. Figures 5 and 6 are detailed schematic views of the distal ends of the catheters 60 and 70, in accordance with additional embodiments of the present invention. The catheters 60 and 70 are designed to be inserted into the coronary sinus and withdrawn therefrom into a cover, such as a cover 52, as in the embodiment of Figure 4. The embodiments of Figures 5 and 6 illustrate different types of anchors: catheter 60 has a handle anchor 62, which is compressed within the cover and then expanded to its fully circular shape when released. The catheter 70 has hook anchors 72, which similarly spring outwardly when released from the cover. Figure 7 is a schematic, pictorial illustration showing the proximal end of catheter 40 (the distal end of which is shown in Figure 3), in accordance with one embodiment of the present invention. The proximal end of the wire 42 is fixed to a handle 80. Although the catheter is manipulated in place through the vascular system and into the coronary sinus, the handle 80 is separated from the proximal end of the catheter, so that the wire 42 does not protrude from the distal end of the catheter. Once the catheter is properly positioned in the coronary sinus, the handle 80 is advanced so as to mesh with the proximal end of the catheter. In this position, the distal end of the wire 42 extends out of the distal end of the catheter, as shown in Figure 3. The handle 80 can be fixed against the proximal entry of the channel 36 in this forward position with the object. to prevent relative movement between the catheter and the wire during treatment. Figures 8A and 8B are schematic, pictorial illustrations showing the proximal end of catheter 40 in accordance with another embodiment of the present invention. In this case, a spring clip 84 is provided in order to prevent relative axial movement between the catheter 40 and the wire 42 during the treatment. When the fastener 84 is retracted, as shown in Figure 8A, the wire 42 is free to move in the channel 36. After the wire 42 has advanced distally and has meshed the walls of the coronary sinus, fastener 84 slides in the proximal direction and exerts pressure on the wire 42, as shown in Figure 8B, in order to hold the wire in place relative to the catheter. Figures 9, 10A and 10B schematically illustrate another arrangement for securing the position of the wire 42 within the channel 36, in accordance with a further embodiment of the present invention. Figure 9 is a pictorial illustration, while Figures 10A and 10B are illustrations in sections taken along the line XX in Figure 9. A thumbscrew 88 rotates in a threaded hole in the proximal end of the catheter 40. As shown in Figures 10A and 10B, rotating the screw alternately releases the wire 42 to move within the channel 36 or secures the wire in place. Figures 11A and 11B are schematic, side views showing another method for anchoring the distal end of the catheter 30 (Figure 2) within the coronary sinus 28, in accordance with one embodiment of the present invention. This method is based on the presence of a stent 90 inside the coronary sinus. Stents of this type are described, for example, in the Patent Application Publication of E.U.A. US2003 / 0097172, the disclosure of which is incorporated herein by reference. As described in this patent, said stents can be implanted in the coronary sinus in order to decrease the diameter of the coronary sinus and thus restrict blood flow from the coronary veins within the heart. It has been shown that this type of restriction promotes angiogenesis. However, in the present embodiment the stent 90 is simply used as a platform for anchoring the catheter 30, and the therapeutic properties of the stent are not a material of the present invention. Therefore, the principles of the present embodiment could also be implemented using other types of vascular stents. As shown in Figures 1 A and 11 B, once the catheter 30 is placed in the coronary sinus 28, the wires 34 extend distally out of the catheter and mesh the stent 90. Typically, the stent itself comprises wires or supports , against which the wires 34 hold and hold the catheter in place.

During drug administration, the catheter 30 can be advanced distally along the wires, as shown in Figure 11B, so that the distal end of the catheter is placed within the narrowest part of the stent 90. In this position , the blood flow from the coronary veins within the heart is temporarily blocked, thus facilitating the retrograde perfusion of the therapeutic substances injected into the coronary sinus via the lumen 38 of the catheter 30. Between the treatments, the catheter 30 can be withdrawn at the proximal direction to the position shown in Figure 11 A. In this position, blood can flow out of the coronary sinus into the right atrium, but the catheter can easily be returned to the position shown in Figure 11 B for subsequent treatments. Figures 12A and 12B schematically illustrate another method for anchoring a catheter 92 within the stent 90 in the coronary sinus 28, in accordance with an alternative embodiment of the present invention. Figure 12A is a side view of the catheter, while Figure 12B is a side view taken along line X11 B-X11 B in Figure 12A. In this embodiment, a donut-shaped balloon 94 is attached to the distal end of the catheter 92. During insertion and manipulation of the catheter, the balloon 94 remains deflated. After the distal end of the catheter 92 has been inserted through the shrunken opening of the stent 90, as shown in Figure 12A, the balloon 94 is inflated via an inflation tube 95 to hold the catheter in place, thus as to block the flow of blood through the coronary sinus.

Figures 12C and 12D are schematic views, in sections through the distal end of catheter 92, in accordance with alternative embodiments of the present invention. In these embodiments, numerous separate balloons 96 are peripherally joined to the distal end of the catheter. As in the preceding embodiment, the balloons remain deflated during insertion, manipulation, and removal of the catheter, and are inflated through respective inflation tubes 95 in order to anchor the catheter when the catheter is in place. (Alternatively, a particular inflation tube can be inserted for multiple balloons.) The balloons 96 can be used in conjunction with the stent 90, as in the preceding embodiment, or alternatively can be used to anchor the catheter without the assistance of a stent. Although Figures 12C and 12D show two and four balloons, respectively, the principles of these embodiments can alternatively be applied using one or three balloons or using a larger number of balloons. The embodiment of Figure 12C is advantageous in that the balloons 96 can be anchored to the catheter 92 in place, without trauma to the blood vessel wall, while still allowing blood to flow past the catheter, into the right atrium. Alternatively, in the embodiment of Figure 12D, the balloons can be inflated in a manner suitable to substantially block blood flow. In this configuration, the inflation pressure of the balloons can be controlled in order to regulate the amount of blood flow, thereby increasing or decreasing the venous reverse pressure. For example, the two balloons above and below the catheter in Figure 12D can be inflated to a relatively high pressure in order to anchor the catheter in place, and the pressure in the balloons toward the sides of the catheter can be adjusted up and down until the desired reverse flow or pressure is reached. Figures 13A and 13B are schematic side views of the distal end of a catheter 100, in accordance with even another embodiment of the present invention. The anchors for the catheter in this case are produced by processing the distal end of the catheter 100 from a material, comprising multiple parallel sheets 102. (Although three sheets are shown in the figure, the catheter may alternatively comprise two sheets or four or more sheets of this type, or even a particular sheet protruding on one side.) In one embodiment, sheets 102 are pre-formed from a resilient material so that they fold outwards when released, as shown in Figure 13B. During insertion through the vasculature and into the heart, catheter 100 is contained within flexible cover 52, as shown in Figure 13A. When the catheter 100 is in place within the coronary sinus 28, the cover is removed, causing the sheets 102 to fold outward and the catheter is thus anchored within the coronary sinus, as shown in FIG. 13B. In this configuration, the sheets block at least a portion of the blood flow from the coronary sinus to the right atrium. The degree of blockage can be controlled by proper selection of the sizes of catheter 100 and sheets 02 and of the precise location in the coronary sinus 28 in which the sheets are released. Complete blockage of the coronary sinus is often undesirable, since it can compromise blood flow to the heart muscle and cause a heart attack. To avoid this kind of danger, sheets 102 can be made sufficiently flexible so that the overpressure in the coronary sinus will cause the sheets to deform, thus allowing blood to flow out between the sheets and relieving the blockage. In an alternative embodiment, sheets 102 are formed from a collapsible material. As a result, when the catheter 100 is in place in the coronary sinus, and the cover 52 is removed, the pressure of the blood flow in the coronary sinus pushes the sheets out toward the configuration shown in FIG. 13B. The plates then anchor the catheter in place and partially block the blood flow, as mentioned above. Alternatively, a balloon (not shown in the figures) in the center of the distal end of the catheter 100 can be inflated in order to push the sheets apart. Alternatively, additionally or additionally, the catheter 100 may be anchored in place by other means, such as one of the anchoring wires described above, and sheets 102 may be opened for the purpose of providing a desirable degree of blood flow blockage. . Figure 14 is a schematic side view of a catheter 110 in the coronary sinus 28, illustrating even another method for anchoring the distal end of the catheter, in accordance with one embodiment of the present invention. The catheter 110 comprises a channel 116 with multiple openings 118 in the vicinity of the distal end of the catheter. A resilient wire 120, which is pre-formed into a folded shape, is contained within the channel 116 during the insertion of the catheter 110 through the vasculature. Once the distal end of the catheter has been properly located in the coronary sinus, wire 120 is pushed forward from the proximal end, and is therefore caused to advance out of one of the holes 118. The catheter 110 it may comprise a suitable control mechanism (not shown) for individually opening the different orifices so that the wire 120 exits through the channel 116 through the desired orifice. Alternatively, the catheter operator can determine the hole through which the wire exits by initially aligning the end of the wire with the desired hole, and then rotating the wire into the channel until the pre-bent tip of the wire slides out to through the hole. The advantage of providing multiple orifices 118 in the channel 116 is that it provides the operator with greater flexibility in deciding where and how to anchor the catheter 110. For example, the operator can align one of the orifices 118 with a lateral blood vessel of the sinus. coronary, such as a small cardiac vein 112 or middle cardiac vein 114 (typically under fluoroscopic imaging), and can then push the wire 120 out through the hole so that it enters the selected lateral blood vessel. The bent tip of the wire engages the lateral blood vessel, as shown in Figure 4, and thus anchors the catheter in place, in this way, the operator can determine the depth of penetration of the catheter into the coronary sinus. (Even if the channel 116 has only a particular outlet orifice, the operator may still exert some control over the depth of penetration by proper selection of the lateral blood vessel into which the wire 120 is inserted.) Although the embodiments described above in the present invention specifically refer to the anchoring of catheters in the coronary sinus, the principles of the present invention can be applied similarly in the anchoring of catheters in other locations in the cardiovascular system, as well as in the anchoring of probes invasive of other types in other body passages and cavities. It will therefore be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described above in the present invention. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above in the present invention, as well as variations and modifications thereof that would occur to persons skilled in the art upon reading the same. preceding description and which are not described in the prior art.

Claims (18)

NOVELTY OF THE INVENTION CLAIMS

1. An apparatus for administering a therapeutic substance in a coronary sinus of a patient, comprising: a catheter, which is adapted to be inserted through a blood vessel of the patient into the coronary sinus, and which has a lumen for administration of the therapeutic substance through it to the coronary sinus; and a resilient anchor, which is fixed to the catheter, so that it anchors the catheter in the coronary sinus without blocking the blood flow through the coronary sinus.

2. - The apparatus according to claim 1, further characterized in that the catheter has a distal end and a channel, and wherein the resilient anchor comprises at least one resilient wire, which is arranged to pass through the channel in a manner which protrudes from the distal end of the catheter and meshes a wall of the blood vessel.

3. The apparatus according to claim 2, further characterized in that the catheter has at least one first and second channels, and wherein the at least one resilient wire comprises at least one first and second wires, which are arranged to pass respectively through the first and second channels so as to mesh the blood vessel wall in two or more locations on different sides of the catheter.

4. - The apparatus according to claim 2, further characterized in that the at least one resilient wire comprises a shape memory material, which is held straight within the channel and is pre-shaped to bend toward a predetermined shape after protruding to starting from the distal end so that the wall of the blood vessel engages.

5. - The apparatus according to claim 4, further characterized in that the predetermined form comprises at least one of a handle, a spiral and a zigzag shape.

6. The apparatus according to claim 4, further characterized in that the predetermined shape comprises a fold, and wherein the at least one resilient wire is adapted to be folded from the catheter into a blood vessel connecting the coronary sinus and engages the wall of the lateral blood vessel.

7. The apparatus according to claim 2, further characterized in that the channel has multiple exit holes in different locations along the distal end of the catheter, and is arranged to allow an operator of the device to choose one of the orifices. of exit, and advance the at least one resilient wire through the chosen outlet orifice so as to mesh the blood vessel wall in a desired location.

8. The apparatus according to any of claims 2-7, further characterized in that the channel has a proximal inlet, and wherein the at least one resilient wire has a proximal end and comprises a handle, which is fixed to the end proximal of the at least one resilient wire for use by an operator of the apparatus that manipulates the wire in the channel, such that the handle meshes the proximal inlet of the channel when the at least one resilient wire extends completely from the distal end of the catheter .

9. - The apparatus according to any of claims 2-7, further characterized in that the channel has a proximal end, and wherein the catheter comprises a fixing mechanism for securing the at least one resilient wire in place at the end. proximal of the channel after the at least one resilient wire has meshed the wall of the blood vessel so that relative axial movement between the catheter and the at least one resilient wire is prevented.

10. - The apparatus according to claim 9, further characterized in that the fixing mechanism comprises a spring fastener, which is arranged to press against the at least one resilient wire.

11. - The apparatus according to claim 9, further characterized in that the fixing mechanism comprises a fixing screw, which is arranged to engage the at least one resilient wire within the channel.

12. - The apparatus according to any of claims 2-7, further characterized in that the catheter comprises a distal end, which comprises multiple parallel sheets, and which adapt to open out to at least partially block blood flow through the coronary sinus during the administration of the therapeutic substance.

13. The apparatus according to claim 12, further characterized in that it comprises a balloon at the distal end of the catheter, which is inflatable in order to push the sheets apart.

14. The apparatus according to claim 1, further characterized in that it comprises a flexible stent, which is arranged to enclose the catheter while containing the resilient anchor, and to be advanced with the catheter through the blood vessel, wherein the flexible cover is adapted to allow the catheter to move distally relative to the cover so that the anchor is released, causing the anchor to mesh with a wall of the blood vessel.

15. The apparatus according to claim 14, further characterized in that the anchor comprises one or more resilient wires, which are pre-formed so that they spring outwardly in a predetermined manner when released from the cover.

16. - The apparatus according to claim 15, further characterized in that the predetermined form comprises at least one of a spiral shape, a handle and a hook.

17. - The apparatus according to claim 14, further characterized in that the catheter comprises a distal end, which comprises multiple parallel sheets formed from a resilient material, and which serves as the resilient anchor, so that after move the catheter distally in relation to the cover, the sheets bend outward and mesh with the wall of the coronary sinus.

18. The apparatus according to claim 17, further characterized in that the sheets are arranged, after being bent outwards, to block at least in part the blood flow through the coronary sinus. 19 - The apparatus according to claim 18, further characterized in that the sheets are constructed so that they deform in response to excessive blood pressure in the coronary sinus, thus allowing blood to flow out of the coronary sinus. 20. - The apparatus according to claim 1, further characterized in that the resilient anchor is arranged to anchor the catheter when engaging a stent implanted in the coronary sinus. 21. An apparatus for administering a therapeutic substance in a coronary sinus of a patient, comprising: a catheter, which is adapted to be inserted through a blood vessel of the patient into the coronary sinus, and which has a lumen for the administration of the therapeutic substance therethrough to the coronary sinus, and which comprises a distal end comprising multiple parallel sheets formed from a collapsible material; and a flexible stent, which is arranged to enclose the catheter so as to contain the flexible sheets, and to advance the catheter through a blood vessel to the coronary sinus, wherein the flexible cover is adapted to allow the catheter moves distally in relation to the cover so as to release the parallel sheets from the cover and cause the sheets to fold outwardly so that the sheets anchor the catheter in the coronary sinus. 22. The apparatus according to claim 21, further characterized in that the sheets are adapted to fold out under a pressure of blood flow in the coronary sinus. 23. The apparatus according to claim 21, further characterized in that it comprises a balloon at the distal end of the catheter, which is inflatable so as to push the sheets outwards. 24. - The apparatus according to any of claims 21-23, further characterized in that the sheets are arranged, after bending out, to at least partially block blood flow through the coronary sinus. 25. - An apparatus for administering a therapeutic substance in a coronary sinus of a patient, comprising: a catheter, which is adapted to be inserted through a blood vessel of the patient toward the coronary sinus, and which has a lumen for the administration of the therapeutic substance through it to the coronary sinus; and one or more balloons, which are attached to the catheter, and which are inflatable so as to anchor the catheter in the coronary sinus without blocking blood flow through the coronary sinus. 26. - The apparatus according to claim 25, further characterized in that it comprises at least one additional balloon, which is fixed to the catheter and is inflatable so that it adjustably blocks blood flow through the coronary sinus while the catheter it is anchored in the coronary sinus. 27. - An apparatus for administering a therapeutic substance in a coronary sinus of a patient, comprising: a stent, which is adapted to be implanted within the coronary sinus; a catheter, which is adapted to be inserted through a blood vessel of the patient towards the coronary sinus, and which has a lumen for the administration of the therapeutic substance through it to the coronary sinus; and an anchor, which is fixed to the catheter, and arranged to anchor the catheter to the stent. 28. The apparatus according to claim 27, further characterized in that the stent contains a shrunken opening, and wherein the catheter comprises a distal end that is adapted to pass through the shrunken opening in the stent, and wherein the The anchor comprises a balloon, which is attached to the distal end of the catheter and is arranged to be inflated after the distal end of the catheter has passed through the shrunken opening. 29. The apparatus according to claim 27, further characterized in that the catheter comprises a distal end, and wherein the anchor comprises one or more wires, which are arranged to advance from the distal end of the catheter so as to be the catheter engages, and wherein the catheter is arranged to advance distally along the wires to a position on the stent.