MXPA97004661A - Guide thread for the liberation of farma - Google Patents

Abstract

This invention relates to a drug delivery device (10) having a dry tube (20) which is configured to serve as a guidewire for intraluminal procedures. The distal part of the tube (20) has at least one opening (32) having a diameter suitable for infusing a drug formulation therethrough. The tube (20) preferably is formed into a superelastic material such as nickel and titanium alloy. This invention also relates to various methods that use this delivery device (10) in thrombolytic procedures and other intraluminal procedures.

Description

GUIDE THREAD FOR THE RELEASE OF DRUGS BACKGROUND OF THE INVENTION The present invention relates to a device for releasing drug in the form of a hollow guidewire with at least one perforation at the distal end thereof. Balloon angioplasty is a generally effective procedure to treat vascular diseases, especially aeteroesclerosis. The formation of the plaque in the light of a blood vessel, TS say, a stenosis, produces a narrowing of the light and can in some case occlude the light if it is not treated. This situation in a coronary artery can cause a myocardial infarction, that is, a heart attack. In balloon angioplasty, a balloon placed at the distal end of a catheter is used to dilate the blood vessel and restore its non-occluded state in the area of the stenotic lesion. However, such conventional balloon angioplasty procedures may not be suitable when a stenosis substantially occludes the lumen of the blood vessel. If the outer diameter of a deflated balloon dilatation catheter is larger than the blood vessel space, the balloon can not cross the injury to allow the balloon to inflate and return the unoccupied state to the blood vessel. A similar problem occurs when a stenosis is located in a very narrow blood vessel that is not accessible to conventional balloon dilatation catheters having external diameters of about 0.081 cm to 0.107 cm along its distal portion. The occlusions can be relieved by carrying out a thrombolytic procedure. Said procedures are described in "Phar acologic Adjuncts to Percutaneous Transluminal Coronary Ongioplasty", Coronary Balloon Pngioplasty, 1994, pages 231-260: 250,000 U.I. are initially infused. of urokinase for 10 to 20 minutes for the native coronary arteries and sudden occlusions. For proximal occlusions, a catheter with an infusion guide may be used. An SOS wire or the distal lumen of a conventional balloon catheter is preferred for more distal occlusions. For distal occlusions with tenuous guidewire position, a Tracker 18 infusion catheter (Target Therapeutics, San Jose, California) or an infusion catheter with multiple holes in the wall may be used. In some cases, another dose of 250,000 U.I. of urokinase if there is no evidence of any change. After placing the infusion wire distally in the graft, 50,000 U.I./hour of urokinase is infused through the guiding and infusion catheter. Alternatively, if the guide position is stable, it can be used alone to infuse urokinase into the graft. The PTCO of underlying lesions can be treated later when the thrombus is not visible or when there is a gap to allow flow in the distal native coronary artery. In some cases, a thrombolytic procedure will only be partially successful and a thrombus will remain. In other cases, a thrombotic obstruction will be removed causing an underlying injury. In such cases, it may be desirable to perform a balloon angioplasty procedure at the site where the thrombus remains or at the site of the underlying injury. After a thrombolytic procedure, a stenosis prosthesis can be implanted to hold the vessel wall. These prostheses are used to hold and make light larger, provide a smooth surface, reinforce vessel dissections, attach tissue flaps, reduce the risk of plaque rupture, decrease the incidence of complications and reduce the incidence of reestenoeis Many different types of prostheses can be used, such as radially self-extending prostheses or extensible balloon grafts. Normally, the prosthesis is placed on the distal end of a thread-guided release catheter so that the prosthesis can be maneuvered adjacent to the treatment side and deployed therein. After unfolding, it may be necessary to expand the prosthesis further with a balloon catheter. Therefore, it is an object of the invention to provide a drug delivery device that can traverse a very narrow occlusion to the desired location and subsequently act as a guidewire for an angioplasty balloon catheter, a graft delivery device. or other devices to perform intralutal procedures.

BRIEF DESCRIPTION OF THE INVENTION These and other objects are achieved by the drug delivery device of the present invention. This drug delivery device has a hollow tube and at least one perforation at the distal end of the tube in hydraulic communication therewith. This may have a flexible dietal segment connected to the distal end of the hollow tube and / or a removable connection connected adjacent the proximal end of the hollow tube. The device will be flexible and will have a sufficient longitudinal stiffness. Flexibility is desirable for the device to travel along the sometimes tortuous path used to reach the treatment site. This is especially true when the treatment site is a blood vessel, such as the renal, carotid or coronary arteries. Longitudinal stiffness is preferred to provide "ease of pushing". This "ease of pushing" ensures that the physician can push the device through the anatomy to the appropriate treatment site. Preferably, the tube is made of a superelastic material or that maintains the shape. Said material includes alloys of nickel and titanium, nickel and its alloys and titanium and its alloys. This material allows the angioplasty device to conform to an external diameter as small as 0.025 cm, so that it can act as a conventional guide wire for a balloon dilatation catheter for PTC or a graft delivery catheter. In summary, the present invention relates to a drug delivery device having a hollow tube configured to serve as a guide wire for intraluminal devices such as a proximal part and a distal portion and defining a light therein. The distal part of the tube has at least one opening with a suitable diameter for the infusion of a drug formulation therethrough. The at least one opening is in hydraulic communication with the light. The hollow tube may be formed of a superelastic material, such as a material selected from the group consisting of the nickel-titanium alloy, nickel and its alloys, and titanium and its alloys. The tube may have an external diameter of about 0.25 cm to about 0.097 cm, preferably about 0.036 cm. The light may have a diameter of about 0.013 cm to about 0.089 cm. A flexible distal segment can be connected to the distal part of the hollow tube and this can be constituted by a central core, generally solid, which can have a spiral wound spring disposed coaxially around the solid central core. The present invention also relates to a dilation device for drug release with a hollow tube configured to act as a guide wire for intraluminal devices and having a proximal part and a distal part and defining a light therein. The distal part of the tube has at least one opening with a suitable diameter for the infusion of a drug formulation therethrough. The at least one opening is in hydraulic communication with the light. The device also has a balloon dilatation catheter with a dilatation balloon attached to a catheter and a lumen for the guidewire adapted to receive the hollow tube. The hollow tube may be formed of a superelastic material, such as a material selected from the group consisting of nickel-titanium alloy, nickel and its alloys, and titanium and its alloys. The tube may have an external diameter of about 0.25 cm to about 0.097 crn, preferably about 0.036 c. The light may have a diameter of approximately 0.089 c. The light for the guidewire of the catheter can be at least partially arranged around the hollow tube. The present invention also relates to a device for deploying a stenosis prosthesis and for drug delivery with a hollow tube shaped to serve as a guidewire for intraluminal devices and having a proximal part and a distal portion and defining a lumen in its interior. The distal part of the tube has at least one opening with a suitable diameter for the infusion of a drug formulation therethrough. The, at least one opening, is in hydraulic communication with the light. The device also has a catheter for deploying a stenosis prosthesis with a light for the guidewire adapted to accommodate the hollow tube. The hollow tube may be formed of a superelastic material, such as a material selected from the group consisting of nickel-titanium alloy, nickel and its alloys, and titanium and its alloys. The tube may have an outer diameter of about 0.25 cm to about 0.097 cm, preferably about 0.036 cm. The light may have a diameter of about 0.013 cm to about 0.089 cm. The light for the guidewire of the catheter can be at least partially arranged around the hollow tube. The present invention also relates to a method for removing a thrombotic block using a drug delivery device with a hollow tube having a proximal part and a distal part and defining a light therein, in which the distal part has a drug release part having at least one opening having a suitable diameter for the infusion of a thrombolytic agent therethrough, the opening being in hydraulic communication with the light. The method includes advancing the drug delivery device through the vasculature of a patient so that the drug release part is approximately at the site of the thrombotic obstruction. An underlying lesion may be discovered after the thrombolytic agent has been infused. The method may also include advancing a balloon dilation catheter over at least part of the hollow tube so that the balloon is positioned adjacent to the underlying lesion and dilating the underlying lesion with the dilatation balloon. The method may also include advancing a stenosis prosthesis delivery catheter having a prosthesis therein over at least part of the hollow tube and deploying the prosthesis from the prosthesis delivery catheter. The method may also include removing the prosthesis delivery catheter, advancing a balloon catheter over at least part of the hollow tube until a balloon is placed inside the prosthesis and inflating the balloon to extend the prosthesis.

BRIEF DESCRIPTION OF THE DRAWINGS The following figures have been provided to illustrate, not to limit, the present invention. Figure 1 is a side elevational view, partially in section of an embodiment of the drug delivery device of this invention; Figure 2 is a side elevational view in section of the distal portion of another embodiment of the drug delivery device of this invention; Figure 3 is a cross-sectional view taken along line 3-3 of Figure 2; Figure 4 is a cross-sectional view taken along line 4-4 of Figure 2; Figure 5 is a cross-sectional view of an alternative embodiment of the present invention; Figure 6 is a cross-sectional view of an alternative embodiment of the present invention; Figure 7 is a side elevational view in section of the distal portion of yet another embodiment of the drug delivery device of this invention; Figures 8 to 11 are schematic views showing a method of using the drug delivery device of this invention in a PTCA process; and Figures 12 to 13 are schematic views showing a method of using the drug delivery device of this invention in a method of deploying a stenosis prosthesis.

DETAILED DESCRIPTION OF THE INVENTION The drug delivery device 10 of this invention includes a hollow tube 20. To serve as a guidewire, the tube 20 should have an outer diameter of about 0.254 cm to about 0.097 cm, preferably about 0.254 cm to about 0.051 cm and more preferably about 0.036 crn. Said external diameters will allow the device 10 to be inserted into very small blood vessels and allow it to pass through very narrow lesions. In addition, conventional coronary guide wires have external diameters of 0.036 crn. In this way, the hollow tube 20 can serve as a guidewire for conventional balloon dilatation catheters used in coronary arteries. Of course, the desired external diameter of the device will depend on the particular application. In this way, a brain application will usually use diameters more than p > equeños (e.g., approximately 0.0254 cm), while applications in the upper part of the leg will generally use larger diameters (e.g., approximately 0.0889 cm). The wall thickness of the tube 20 can generally vary from about 0.01 cm to about 0.0032 cm. The wall thickness should be large enough to maintain the structural integrity of the tube 20 without unduly narrowing the lumen 22 of the tube 20. The lumen 22 should remain large enough to allow distribution of drug formulations through the openings. and at a desired pressure and for a desired period of time. The diameter of the light 22 will preferably vary from about 0.025 cm to about 0.064 cm. For the tube 20 to have a lumen 22 extending therethrough still have a sufficiently small outer diameter, it will be preferable to form the same in a material that maintains the shape or superelasticity. Said material that maintains the shape or superelastic is defined as an alloy that can be subjected to an apparent plastic deformation and that still returns to its original shape when the load is removed or when it is heated. This difference depends on the molding process of the material that maintains the shape or superelastic. It will be understood that the reference to a superelastic material from here refers to a material having the above characteristics. Suitable superelastic materials include nickel and titanium (nitinol) alloys, nickel and its alloys, and titanium and its alloys. Other examples of euperelastic materials include e.g., Silver-Cadmium (Ag-Cd), Gold-Cadmium (Au-Cd), Gold-Copper-Zinc (Ou-Cu-Zn), Copper-Aluminum-Nickel (Cu-Al-Ni), Copper-Gold-Zinc (Cu ~ Au-Zn), Copper-Zinc (Cu-Zn), Copper-Zinc-Aluminum (Cu-Zn-Al), Copper-Zinc-Tin (Cu ~ Zn-Sn), Copper-Zinc-Xenon (Cu -Zn-Xe), Beryl Iron (Fß3Be), Platinic Iron (Fß3Pt), Indian-Thallium (In-Tl), Iron-Manganese (Fe-Mn), Nickel-Titanium-Vanadium (Ni-Ti-V), Iron -Nickel-Titanium-Cobalt (Fe-Ni-Ti-Co) and Copper-Tin (Cu-Sn). For a full description of superelastic alloys see Schetsky, L. McDonald, "Shape Memory Alloys", Encyclopedia of Chemical Technology, 3_? Edition, John Uiley and Sons, 1982, vol. 20, pages 726-736. A preferred nickel-titanium alloy can be obtained from Rayche Corporation of Menlo Park, CA under the tradename Tinel7. This material shows both flexibility and longitudinal stiffness. In addition, this material is hard, resistant, biocompatible and can be joined with other components of the device 10. Alternative materials for the hollow tube include stainless steel and composite materials of polymers and metals. The distal portion of the device has a drug release part 30 with at least one opening 32 for distributing a drug formulation. Preferably, approximately 2 to approximately 40 openings 32 are present. These holes may be on the sides of the distal portion of the tube as shown in Figure 1 and, optionally, the distal end 26 of the tube 20 may also contain minus an opening 32 to allow the drug solution to be distributed therethrough. As shown in Figure 6, the distal end 26 has a wall 21 with one or more openings 32 '. In some cases, the distal end 26 of the tube 20 will contain at least one opening 32 and there will be no openings in the sides of the distal portion of the tube. The drug release part will preferably be located in the most distal segment of the tube, preferably about 7.6 ero from the end of the device and more preferably about 3.8 cm from the end of the device. The openings 32 may be perforations or slots of various shapes, such as ovoids, circles, rectangles or triangles with or without beveled edges. The procedures for molding the openings 32 are described in Kraus et al. (U.S. Patent No. 5,256,144) and Sarnson et al. (U.S. Patent No. 4,998,923). The circular openings generally have a diameter of about 0.025 cm to about 0.25 cm. In the embodiment shown in Figure 7, the distal segment 24 closes the lumen 22 of the tube 20. The solid yarn has a proximal portion attached to the distal end of the tube 20. A spiral winding is connected to the distal end of the solid yarn. The solid thread of segment die + to 24 is tapered in this configuration along the distal part to increase its flexibility. In addition, the solid thread may or may not extend to the distal end of the spiral winding depending on the characteristics desired for the distal segment 24. The solid thread and the spiral winding may be formed of stainless steel. Alternatively, the solid thread can be formed into a superelastic material and the spiral winding can be formed from tungsten. In yet another embodiment (not shown), the outer diameter of the solid wire of the distal segment 24 is constant and is substantially equal to the internal diameter of the distal part of the tube 20. A small light is present along the solid thread and in communication Hydraulic with the light 20 to provide a passage way to the openings for the drugs that are present in the solid thread. Again, the distal end of the solid thread in this configuration may or may not be comatose and may or may not extend to the distal end of the larval or spiral coil. The proximal end of the device 10 may include a removable 40 connection to allow attachment to other devices, such as inflation / deflation devices (not shown) to the device 10. A conventional Touhy Borst connection is preferred. The device 10 can be used in this way to carry out a trilbolitic process. For example, c. It can maneuver a guide catheter in the position and a device 10 can be maneuvered through the guide catheter to the site of an occlusion. See Figure 8. When the openings 32 are properly aligned approximately around the site of occlusion, the drugs can be dispensed to perform a thrombolytic procedure. See Figure 9. After a thrombolytic procedure, a balloon may be needed to dilate a remaining thrombus or an underlying lesion. This may also be desirable to dilate a stenosis located in the vicinity of the thrombotic obstruction. To perform a balloon dilatation procedure, the drug delivery portion 30 can be moved initially distally beyond the (anterior) site of the thrombotic obstruction. See Figure 10. In some cases it will not be necessary or desirable to move the drug release pair + e distally. In any case, the connection 40 can then be removed and a balloon dilatation catheter 50 guided by a wire on the device 10 can be advanced until the balloon 52 of this catheter is positioned at the desired location. The balloon 52 can then expand the lesion or obstruction. (See Figure 11). Once the procedure is completed, both the device 10 and the balloon dilatation catheter 50 can be removed. The balloon dilation devices and methods are described, e.g. in the following U.S. Patents Nos. 5,306,247, 5,295,961, 5,232,445, 5,209,729, 5,163,906, 4,947,864 and 4,762,129. (All documents cited in this application, including the above, are added here in their entirety for all purposes). The device 10 can also be used for other methods, such as for releasing antiproliferants to treat restenosis. The device 10 can also be used as a guidewire to provide support for a deployment catheter of a prosthesis. A prosthesis-releasing catheter guided by a wire can be advanced over the device 10 until the prosthesis is properly aligned at the treatment site. See Figure 12. At this point, the prosthesis can be deployed in a conventional manner from the prosthesis delivery catheter, by placing the prosthesis in place. See Figure 13. If desired, a balloon catheter can then be advanced over the device 10 until the balloon of this catheter is within the prosthesis. The balloon can then be inflated to further extend the prosthesis. Subsequently, the balloon can be deflated and the balloon catheter removed. Graft deployment devices are described, for example, in U.S. Patent No. 5,201,757. Antithromytics, antithrombin, antiplatelet, antiproliferant or any other type of drugs can be used with the present invention. The drug is usually introduced into the proximal end of the tube via a syringe. Injection is stopped after the drug has been applied, usually at low pressures (eg from about 102.3 kN / m2 to 405.3 KN / m2) and for the desired period of time (usually from about 20 seconds to about 3 minutes). , although in some cases for longer times such as one day). Specific examples of drugs that can be used with this invention are urokinase and heparin. Adjuvants can also be delivered by the present invention, such as muscle relaxants, vasodilators or any adjuvant that can be used with invasive cardiology procedures. The drug formulations to be used with the present invention will generally have viscosities from about 1 cp (centipoise) to approximately 10 cp in small diameter devices., and from approximately 1 cp to approximately 10,000 cp in devices with larger diameters. As used herein, the term "drug formulation" refers to any liquid drug, with a liquid or gelatinous base or the like. The term includes, but is not limited to, liquid suspensions, liquid emulsions, gels, suspensions, colloidal suspensions, liquid mixtures, mixtures of liquids and solids, thixotropic solutions and the like. When the drug formulations are distributed, in general, at least one opening 32 will be aligned with the occlusion. Preferably, all or most of the openings 32 will be adjacent to the blockage to preserve all of the drugs that are used. However, the present invention will generally be effective even when some or all of the openings are somewhat upstream or downstream of the occlusion at the time the drug formulations infuse. Although this invention has been described in connection with the performance of thrombolytic procedures, angioplasty and procedures for deployment of stenosis prostheses on coronary arteries, it will be understood that the invention has an applicability equal to angioplasty procedures or for the deployment of stenosis prostheses performed in other peripheral arteries such as the carotid artery, the cerebral arteries and the renal artery. The present invention can be easily adapted to be compatible with the 0.053 cm to 0.089 cm and / or 0.097 cm systems commonly used in the periphery. The present invention can also be used in different intraluminal procedures, such as the removal of stenosis using laser light energy as described in U.S. Patent No. 5,176,674. Thus, it is noted that a drug delivery device is provided that can traverse a very narrow occlusion or an extremely small blood vessel. One skilled in the art will appreciate that the described embodiments are presented for purposes of illustration and not limitation.

Claims (23)

NOVELTY OF THE INVENTION CLAIMS

1. - A drug-releasing device (10) that compresses: a hollow tube (20) configured to serve co or guide wire for intraluminal devices and having a proximal part and a distal part and defining a light (22) in its interior; the distal part of the + ubo (20) having at least one opening (32) having a suitable diameter for the infusion of a drug formulation therethrough, the opening (32) being in hydraulic communication with the lumen (22).

2. The drug delivery device (10) of claim 1, wherein the hollow tube (20) is formed into a superelastic material.

3. The drug delivery device (10) of claim 2, wherein the superelastic material is selected from the group consisting of an alloy of nickel and titanium, nickel and its alloys and titanium and its alloys.

4. The drug delivery device (10) of claim 2, wherein the tube (20) has an outer diameter of about 0.25 cm to about 0.097 cm.

5. The drug delivery device (10) of claim 4, wherein the tube (20) has an outer diameter of approximately 0.036 cm.

6. The drug delivery device (10) of claim 4, wherein the light (22) has a diameter of about 0.013 cm to about 0.089 cm.

7. The drug delivery device (10) of claim 1 further comprising a flexible distal segment (24) connected to the distal portion. of the hollow tube (20).

8. The drug delivery device (10) of claim 7 wherein the flexible distal segment (24) comprises a generally solid core.

9. The drug delivery device (10) of claim 8, further comprising a coiled elastic coil arranged coaxially around the generally solid core.

10. A device for dilating and releasing drug comprising: a hollow tube (20) configured to serve as guide wire for intraluminal devices and having a proximal part and a distal part and defining a light (22) therein the distal part of the tube (20) having at least one opening (32) having a suitable diameter for the infusion of a drug formulation therethrough, the opening (32) being in hydraulic communication with the lumen (22); and a balloon dilatation catheter (50) comprising a dilatation balloon (52) attached to a catheter, the catheter having a lumen for the guidewire adapted to receive the hollow tube (20).

11. The drug dilating and releasing device of claim 10, wherein the hollow tube (20) is formed into a superelastic material.

12. The drug dilating and releasing device of claim 11, wherein the superelastic material is selected from the group consisting of an alloy of nickel and titanium, nickel and its alloys and titanium and its alloys.

13. The drug dilating and releasing device of claim 11, wherein the tube (20) has an outer diameter of about 0.25 cm to about 0.097 crn.

14. The drug dilating and releasing device of claim 13, wherein the tube (20) has an outer diameter of about 0.036 cm.

15. The drug dilating and releasing device of claim 13, wherein the lumen (22) has a diameter of about 0.013 cm to about 0.089 cm.

16. The drug dilating and releasing device of claim 10, wherein the lumen for the guidewire of the catheter is at least partially disposed about the hollow tube (20).

17. A device for drug release and deployment of a stenosis prosthesis comprising: a hollow tube (20) configured to serve as a guidewire for intraluminal devices and having a proximal part and a distal part and defining a lumen ( 22) inside it, with the distal part of the tube (20) having at least one opening 7? (32) having a suitable diameter p > for the infusion of a drug formulation therethrough, the opening (32) being in hydraulic communication with the lumen (22); and a stenosis prosthesis deployment catheter having a lumen for the guide wire adapted to receive the hollow tube (20).

18. The device for drug delivery and deployment of a prosthesis of claim 17, wherein the hollow tube (20) is formed in a superelastic material.

19. The device for drug delivery and prosthesis deployment of claim 18, wherein the superelastic material is selected from the group consisting of an alloy of nickel and titanium, nickel and its alloys and titanium and its alloys.

20. The device for drug delivery and prosthesis deployment of claim 18, wherein the tube (20) has an external diameter of about 0.25 c to about 0.097 cm.

21. The device for drug delivery and prosthesis deployment of claim 20, wherein the tube (20) has an outer diameter of approximately 0.036 cm.

22. The device for drug delivery and prosthesis deployment of claim 20, wherein the light (22) has a diameter of about 0.013 cm to about 0.089 cm.

23. - The device for drug delivery and prosthesis deployment of claim 17, wherein the light for the guide wire of the catheter is at least partially arranged around the hollow tube (20).