MXPA96004296A - Angioplast device - Google Patents

Abstract

The invention relates to an angioplastic device (10) consisting of a metal tube (120), a fixed balloon (30) adjacent to the distal end of the tube (20) and in liquid communication with the tube opening (22) ( twenty). A flexible distal segment connected to the distal end of the tube and a removable shaft (40) connected adjacent to the proximal end of the tube (20). The tube (20) is preferably made of a superelastic material such as a titanium-nickel alloy. This invention also relates to various methods for using this angioplastic device (1

Description

NINOPLUSTIC DEVICE Background of the Invention The prese + i ition refers to an angioplastic device that may have the shape of a thread < hollow metallic juice with a glo or coupled at the distal end of the same ,. The angioplas + a lobular is an effective procedure or the + ratapuen + or vascular e fermed, especially atherosclerosis. The formation of plaque in the lumen of a blood vessel, that is, a stenosis, narrows the lumen and could possibly occlude the lumen completely if left unattended. This situation in a coronary artery is known as a myocardial infarction, that is, an attack on the heart. In the end of the appearance of the globular angioplasty, the treatment for a steno-ica lesion in a blood vessel was bypass surgery. This required the use of a,. or + or artificial or one of the blood vessels of the patient + e, to avoid diseased vessels. To adequately co-replace the replacement blood vessel, the physician needed specialized surgery to access the body part, so that the blood vessel could be sewn in the right place. F the ang globular oplastia, a balloon placed at the distal end of a catheter is used to dilate the blood vessel and re-establish its flow in the area of the lesion "• * <tentetic to existence and location of a lesion is notified is first determined- using a diagnostic catheter to inject a contrast liquid into the affected area which is examined inedLante fl oroscopi .. Rlli where the coronary artery is going to be treated, that is, through A PTCR procedure (angioplas coronary t ranslurmn l percutanea), the globular dilatation catheter is normally introduced into the body by an access area, usually by the femoral artery, away from the blood vessel treated and is carried by the vascular system to the Treatment area Before a globular dilatation catheter can be brought to the proper site, a guide catheter is inserted, usually through the femoral artery in the groin area, with a 3-coil wire. ocated within it and extending beyond the distant end, and is conducted through the vasculature, around the arch of the aorta, where the thread is extracted in 3 to the coronary artery of the coronary artery to be treated. The catheter provides support support for the advancement of the globular dilatation catheter to the treatment area. The catheter also allows adequate amounts of contrast fluid to be injected through it with the globular dilatation catheter inside so that the physician can examine the treatment area by fluoroscopy during the procedure. When a globular dilatation catheter is to be used by a wire, that is, a globular dilatation catheter on the wire or a rapid exchange globular dilatation catheter, a metallic guidewire will be guided through the guide catheter, first to the site of attachment to provide a path through which the globular dilation catheter can advance. The guidewire is inserted into the guide catheter so that it extends beyond the distal end of the guide catheter and through the stenotic lesion to be treated. This provides the globular dilatation catheter with access to the stenotic esion to be treated. When using a globular dilatation-wire catheter, an additional guiding thread is not needed. Instead the globular dilatation catheter has a fixed wire that serves to guide the globular dilatation catheter to the attachment area. A problem that can occur is when the stenosis obstructs substantially between the blood vessel Jumen. If the contour (outer diameter) of the expansion catheter "Obular is too large, it will not be able to pass through the lesion to allow the balloon to inflate and restore blood vessel flow. An associated problem occurs when the stenosis is located in a very narrow blood vessel. These lesions may be inaccessible to a standard globular dilation catheter, which has a normal outside diameter between 0.081 cm and 0.091 cm in the vicinity of its distal portion. Although guiding threads having an outside diameter between 0.035 cm and 0.045 cm can "pass through very narrow stenoses in an extremely narrow, angular vessel, said guidewires can not dilate the stenois.Another problem can occur in an angioplasty procedure. a globular dilation in which the doctor may have to use more than one globular dilation catheter, that is, change globular dilatation catheters, if the original globular dilatation catheter balloon is not of the appropriate size to treat the spherical lesion This is a major problem for globular dilation catheters guided by wire since the guide wire can remain in place - through the stenosis while the globular dilatation catheters are exchanged. If a fixed wire globular dilation catheter is used, access to the stent lesion will be lost if the catheter is removed. ioplast i co * a retaining means can be used to hold the vessel wall. The retention gods are used to increase- and maintain the lumen, to provide a smooth surface, to reinforce vessel dissections, to fix the flanges of the tissues, to reduce the risk of rupture of the plaque, to decrease the incidence of complications and reduce the incidence of stenosis. Many different types of retention means can be used, such as radially self-expandable, or globular expandable. Normally, the retaining means is placed at the distal end of a guided delivery catheter or a thread so that the retaining means can be led alongside the treatment area and deployed there. After deployment, under certain circumstances, it may be necessary to expand the retention means once it has been deployed. This requires the use of an additional thermo-globular catheter that can be conducted to the re + option so that the balloon can expand more the retention medium. Due to all the steps and the different devices needed -To perform this procedure, the risk of rauma in the patient is high. Therefore the object of this invention is to provide an angioplasty device that can traverse a very narrow stenosis or an extremely narrow blood vessel and dilate the stenotic lesion. It is also an object of this invention to provide an angioplasty device that acts as a guidewire and can predict a stenosis. It is a further object of this invention to provide an angioplast device that can be used with normal angioplast balloon dilatation catheters in which a balloon change is indicated. It is also an objective of the invention to provide an angioplastic device that minimizes the number of different intervention devices needed to perform a globular angioplasty and further dilate the retention means in the area of the angioplastic procedure.

SUMMARY OF THE INVENTION These and other objectives are achieved with the angioplastic dialysis of this invention.This angioplasty device comprises a hollow metallic tube, a fixed balloon adjacent to the former remote oar of the metallic tube. In liquid communication with it, a flexible distal segment connected to the distal end of the metal tube and a detachable shaft connected to the proximal end of the metal tube. of the treatment in the coronary artery, they should be both flexible and rigid.Preferably the metal tube will be made of a moldable material or a superelastic material.This material includes alloys nickel-titanium, nickel and its alloys and titanium and its alloys This material allows the manufacture of angioplastic devices with an outside diameter as small as about 0.025 crn so that it can act as "/ -) standard guide tube for a globular dilatation catheter PTCfl or a catheter for releasing the retention medium when the shaft is removed from its proximal end. Brief Description of the Dibulos The FTG. 1 is a partially sectioned side elevational view of a representation of the angled optic device of this invention; The FTG. 2 is a sectional side elevation view of the distal zone; of another representation 1 the device - "" "" "- igioplastico of this invention; The FTG 3 is a cross sectional view taken along the line 3-3 of the FTG 2; in sectioned side elevation of the distal region of another representation of the angioplastic device of this invention; FIG.5 is a sectional side elevational view of the distal region of another representation of the angioplastic device of this invention; a side elevation view in section of 1 to the dietal zone of another representation of the angioplastic device of this invention; FIG. 7-9 are schematic views showing a method of using the angioplastic device of this invention in a PTCO procedure; and FTG 10-12 are schematic views showing a method of using the angioplast device of this invention in a method of deploying a retention means. DETAILED DESCRIPTION OF THE INVENTION The angioplast device 10 of this invention includes a hollow metal tube 20. Preferably the tube 20 has an outer diameter less than about 0.15 cm and preferably measures about 0.036 crn. These dimensions allow the device 20 to be Insert into very small blood vessels and allow you to traverse very ~~ * st rechas lesions. In addition, the standard guide wires have an outer diameter of 0.035 crn. Therefore, by causing the outside diameter of the hollow metal tube to have this dimension, ie, 0.036 crn, the device 20 can serve as a guiding thread for standard globular dilatation catheters used in the coronary arteries. It is understood that larger dimensions may be used if the device 20 is not used as a guidewire for other globular dilatation catheters. The thickness of the par-ed of the tube 20 can vary between 0.01 c and 0.005 cm. The thickness of the wall 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 be kept large enough to allow the balloon 30 to be inflated and deflated in a Reasonable time may be 15 to 20 seconds .. For the tube 20 to have a lumen 22 that extends into it and also has an outside diameter of about 0.036"?, Should be made up of an oldeable or superelastic material. Said mouldable material or ico superellae is defined as an alloy which may be subject to a plastic deformation and which however may return to its original shape when the load is released or heated. This difference depends on the method of forming the moldable or superelastic material. It is understood that hereinafter the reference to a superelastic material means a material having the above characteristics.

"" - Appropriate super-materials include alloys or that! -t i tamo (not t mol), nickel and its alloys or titanium and its alloys. Other examples of superalloy materials include, for example, Silver-Cadmium (Ag-Cd), Gold-Cadmium (AuCd), Gold-Copper-Zinc (fiu-Cu-Zn>, Copper-Al urní n ~ o ~ N Quel (Cu-AlNi), Copper-0ro-7mc (Cu-flu-Zn), Copper-7? Nc (Cu-Zn), Copper-Zmc-Al umi nio (Cu-Zn-Al), Copper-Zmc-Tin (Cu-Zn-Sn), Copper-Zinc-Xenon (Cu-Zn-Xe), Iron Beplato (Fe3Be), Iron Platmate (Fe3Pt), Indian-Tal 10 (m-Tl), Iron-Manganese (Fe-end), Nickel-Titanium-Vanadium (N1-T1 -V), H? Er-ro ~ N? Quel-T? Tan? O-Cobalt (Fe-Ni-Ti- Co) and Copper-Tin (Cu-Sn). See Schetsl-y, L. McDonald, "Shape Memory Alloys", Encylopedia of Chemical Technology (3 ed.), John Wiley R Sons, l < 382, Vol 20. pages. 726-736 for a complete study of superelastic alloys. A preferably nickel-titanium alloy can be obtained from Raychem Corporation of Menlo Par, CA under the registered trademark TmelR. Fste .atepal shows both flexibility and rigidity. Furthermore, this material is hard, strong, biocompatible, and connectable with the other components of the device 10. A flexible distal segment 24 is connected to the distal end of the tube 20. In the representation shown in FIG. 1, the distal segment 24 includes a solid wire that is surrounded at least in its distal zone by a helical spiral. In this representation, segment 24 «list! The lumen 22 of the tube 20 closes. A lateral conduit 21 located in the lateral wall of the hub 20 places the globular cavity 12 in liquid communication with the lumen 22. The soli and the helical spiral can be made of stainless steel.

Automatically, the solid wire could be made of superplastic material and the helical spiral of Tungsten. In a second representation, see the FTG. 2, the segment 24 di such does not close the lumen 22 of the tube 20. In its place the solid wire has a proximal portion fixed to the end of the tube 20. The proximal portion of the solid tube does not completely opening 22 »This allows the inflation fluid to flow from the far end! from the tube 20 to the globular cavity 32 enclosing the distal end of the tube 20. A helical spiral is connected to the end of the solid wire. In this embodiment, the proximal neck of the balloon 30 is fixed adjacent the distal end of the tube 20 while the distal neck of the balloon 30 is connected to the helical coil.

The solid wire of distal segment 24 can be carved into shape , Only throughout its portion di pr to increase its flexibility. See FIG. 4. Furthermore, the solid wire may or may not extend to the distal end of the helical spiral depending on the characteristics desired for the segment 24 di such. See the FTG ,. 5. In another representation, see the FTG. 6, the outer diameter of the solid wire of the segment 24 di such is constant and is substantially equal to the internal diameter of the di stern portion of the tube 20. A small lumen is formed along a 1 l Solid wire connection to provide a flow path in the globular cavity pair to the inflation liquid. Again, the distal end of the solid wire in this representation may or may not be carved in a comma shape and may or may not extend to the far end! of the helical spiral. The balloon 30 can be made from any suitable material such as polyethylene phthalate ter (PET), polyolefms, for example polyethylene or polyolefin copolymers (POC), pollamides, co or nylon or polyurhane, The cilobo 30 can be joining the tube 20 and the helical spiral by means of any conventional joining technique as it may be a chemical adhesive or by welding. The proximal end of the device 10 contains a detachable axle 40 that is capable of adapting other devices, such as a device for inflating / disinfecting (not shown) the device 10. It is preferable to use a Touhy Borst est shaft. standard In this way the device 10 can be used as a guide wire when the shaft 40 is disassembled. For example, once the guide catheter has been guided to the proper position, the device 10 can be passed through the guide catheter to the place where the stenosis occurred as if it were a standard coronary guidewire. Fig. 7. Once the balloon 30 has been aligned with the stenosis, the balloon 30 can be inflated to dilate the stenosis. See F g 8. Fl device 10 can be used to "predil tie" or dilate "" "or stencil stencil. In any case, if a larger balloon is needed to fully dilate the stenosis, the balloon 30 can be moved distally past the stenosis. Preferably the balloon 30 is deflated first to facilitate the movement of the device 10 directly, then the shaft 40 is disassed and another globular dilatation catheter guided by a thread, having a balloon of different size, can be advanced through the balloon. device 10 until the balloon of that catheter is placed in the stenosis. The largest balloon will now be able to dilate the stenosis completely. See Fig <;1. Once the procedure is complete, both devices, device 10 and the other globular dilatation catheter, can be removed. In addition, the device 10 can also be used to expand a retaining means that has been deployed in the area of the lesion. After having carried out a PTCA procedure as described above, and before the device 10 is retrieved, a catheter for releasing the retention means guided by a wire can be advanced through the device 10 until the means of Retention is properly aligned in the treatment area. See FIGS. 10 and 11. At this point the retention means can be deployed in a conventional manner from the catheter for releasing the retention means. If a greater expansion of the retention means is desired, the device 10 can be brought closer by the interior of the retention means. In that moment the balloon 30 is inflated so as to further expand the tetonization means, see figure 12. Subsequently, the balloon 30 is deflated and the device withdrawn, Another advantage of the device 10 is that it allows the physician to perform Angiography, ie, diagnostic procedures, and globular angioplasty at the same time In a normal situation, a patient suffering from what may be a coronary artery disease will first undergo diagnostic tests. To determine if the patient is an andidate for a PTCA procedure, a diagnostic catheter will usually be inserted into a peripheral artery and taken to the appropriate coronary artery, then the diagnostic fluid is injected through the diagnostic catheter. to allow the physician to examine the coronary arteries by means of uoroscopy If the PTCA procedure is indicated, the diagnostic catheter will be removed and Arrive a catheter-gu to up The right position to start j. procedure a PTCA. As an alternative the patient could go later for the PTCA procedure. This situation is not completely desirable because it subjects the patient to the risk of additional trauma by removing the diagnostic catheter and introducing the guide catheter. However, this has been necessary because diagnostic catheters are not generally suitable for use as guide catheters for globular dilation catheters or for guide wires, since normal guide catheters do not have a lumen lo- "• -, It is large enough to allow the passage of both a normal globular dilation catheter and enough contrast fluid through the general catheter. The catheter is a guide comparable to these because the diagnostic catheter must have a more consistent wall to withstand the pressure when the contrast liquid is injected through it.For example, a 5 Fr. diagnostic catheter may present a lumen. With an inferno diameter of 1.11 cm, a 6 Fr diagnostic catheter can have a lumen with an internal diameter of 0.12 crn and a diagnostic catheter 7 Fr. can present a lumen with an internal diameter of 0.14 cm In comparison, the lumen diameter for guide catheters would be 0.16 cm in a guiding catheter 7 Fr. With the device 10 of this invention, a PTCA process and a diagnostic procedure can be performed at the same time. After a diagnostic procedure has confirmed the need for a PTCA procedure, the "device 10" can be inserted through the diagnostic catheter and delivered to the area of the lesion to be treated. Due to the small size of the conduit of the device 10, sufficient contrast fluid can be injected through the diagnostic catheter, keeping the device 10 there to allow the physician an adequate examination of the affected area by fl uoroscopy. In addition, the small size of the device 10 facilitates its movement through the lumen of the diagnostic catheter. Once the device 10 is properly positioned, the balloon 30 can be inflated to dilate the lesion. Although this invention has been described in association with the practice of angioplastic procedures and the deployment of retention means in coronary arteries, it is to be understood that this invention also has equal importance to angioplasty procedures and the deployment of means of retention performed in other peripheral arteries, as it may be, the carotid artery, the renal artery, and can be manufactured to be compatible with the systems of 0.053 to 0.089 c / or 0.097 cm systems used in the periphery. In this way it is verified that angioplastic device can pass through a very narrow stenosis or a narrowed blood vessel, which can act as a guidewire to predilate or totally dilate a stenosis and that also allows the use of a normal dilatation catheter. , / angioplastic oblate or a catheter for releasing the retention medium and which can also be used to dilate the retention medium after s? deployment. A person familiar with the practice will appreciate that the representations described herein are presented for the purpose of illustration and not for limitation and that this invention is limited only by the claims set forth below.

Claims (6)

NOVELTY OF THE INVENTION CLAIMS

1. An angled optic device (10) consists of: a hollow tube (20) made of a superelastic material having a proximal portion and a distal portion; and presenting a lumen (22) within it; and a balloon (10) having a globular cavity in its interior fixed in the distal portion of the hollow tube (20) and in liquid communication with the lumen (22). 2. The angular arrangement (10) of claim 1 further comprises a removable shaft connected to the proximal portion of the hollow tube. 3. The anginal optic device (10) of the re1dication 1 also comprises a segment (24) distant! flexible connected to the dural portion of the hollow tube (20). 4. The angled oplastic device (10) of claim 3 wherein the flexible distal segment (24) consists of a generally solid center wire that has a lumen with a fluid flowing through it and "? Ue it is connected to the said portion of the hollow tube (20) so that the lumen through which the liquid flows is in communication with the lumen (22) of the hollow tube (20) and with the globular cavity *. 5. The angioplastic device (10) of claim 4 further comprises a coiled spring "" lelycidal arranged coaxially with respect to the generally solid core liner. "5. The angular-optic device (10) of either claims 1-5 in which the r-> superplastic material forming the hollow tube is selected from a group consisting of an alloy of nickel-titanium, nickel and its alloys and titanium and its alloys, 7. A Angioplás device i co (10) consists of: a hollow tube (20) manufactured with a superelastic material that has a proximal portion and a distal portion and has a lumen (22) with a first cross-sectional area that is extends through it to the open end, a fixed wire in the distal portion of the hollow tube (20) having a proximal portion and a distal portion where the proximal portion has a second cross-sectional area which is less than the first cross-sectional area of the lumen (22) to allow fluid to exit the distal open end of the hollow tube; and a balloon (30) having inside it a fixed globular cavity in the distance 0 portion! of the hollow tube (20) and in liquid communication with the open distal end of the hollow tube (20). 8. The anginal optic device (10) of claim 7, wherein the distal portion of the thread is conical in shape. 9. The angioplast device (10) of both claim 7 and 8 furthermore consists of a spring in IB "helical spiral arranged coaxially + eo with respect to the area of the thread, 10. The angiopastic device (10) of claim 7 is further comprised of a removable shaft (40) connected to the proximal portion of the hollow tube (20). The angioplastic device (10) of any of the rei indications 7, 8 or 10 in which the superelastic material forming the hollow tube (20) is selected from a group consisting of a non-nickel alloy. titanium, nickel and alloys and titanium and their alloys 12. The ang ible device if (10) of claim 9 in which the perelastic material forming the hollow tube (20) is selected from a group formed by an alloy of nickel titanium, nickel and its alloys and titanium and its alloys 13. A method for carrying out a dilatation procedure using an LCO angioplast device (10) was a hollow rubo (20) It is made with a superelastic material and it has a di stal and a proximal portion and having therein a lumen (22), and a balloon (30) > which has a globular cavity in its interior fixed in the distal portion! of the hollow tube (20) and in liquid communication with the lumen (22), consists of: advancing the angioplastic device (10) through the vasculature of a patient so that the balloon (30) is placed in the area where the stenotic injury has occurred; inflate the balloon (30) "" - at least partially expand the spherical lesion; deflate * the golbo (30); advancing the angioplasty device (10) distally so that the golbo (30) is placed di ff erently with respect to the stenotic lesion; advance the globular dilatation catheter over the device to the stenotic lesion; and further dilating the stenotic lesion by means of the globular dilatation * catheter. 14. The method of claim 9 further comprises: removing the globular dilatation catheter * from the angioplastic device; advancing a catheter for releasing the retaining means with a retaining means contained therein on the angioplasti co device; deploying the retention means from the release catheter of the retention means; extracting the release catheter from the retaining means; moving the angioplast device (10) or dent of the retaining means so that the balloon is placed therein; and inflating the balloon (30) to dilate the retention mechanism. 15. A method for treating the lumen of a body consists of: advancing an angioplasty device (10) with a hollow tube f20) having in its lower one a lumen (22) and a balloon (30) having a globular cavity - in its intepriority to the hollow tube (20) and that is in liquid communication with the lumen (22) through the vasculature of a patient so that the balloon (30) is placed in the stenotic lesion; inflate the balloon (30) to dilate the stenosis; lesinflar the balloon (30); advancing the cingioplastic device (10) distally < So that the balloon (30) is placed distally with r-speci fi c lesion stenot i ca; advancing a catheter for releasing the retention means with a retention means contained within the envelope of the angioplastic device; deploying the retention means from the retention means releasing catheter so that it radially extends within the lumen of the body; extract the catheter of release of the retention medium; moving the optical device (10) within the retaining means so that the balloon (30) is placed therein; and inflating the balloon (30) to dilate- plus the retention means. L6. One method for performing both angiographic and angioplasty procedures consists of: advancing a diagnostic catheter through the patient's vasculature to the region to be diagnosed and treated; advancing an angioplastic device (10) consisting of, rt hollow tube (20) that is manufactured by a superelastic material and that has a proximal portion and a distal portion and that has a lumen (22) therein, and a balloon (30) having in its interim a fixed globular cavity in the distal portion 1 of the hollow tube (20) and in liquid communication with the lumen (22), through the diagnostic catheter so that the balloon ( 30) is placed in the stenographic lesion; inject the diagnostic fluid through the diagnostic catheter to visualize the angioplastic device (10); or inflate

2. 1 • 1 balloon (30) to dilate the stenotic lesion.