MX2008007850A - Laser cut intraluminal medical devices - Google Patents

Abstract

Laser cut bioabsorbable intraluminal devices or stents and methods for forming such an intraluminal device or stent. A precursor sheet (100) or tube (200) of bioabsorbable material is laser cut in the presence of an inert gas to form an intraluminal medical device or stent having a desired geometry or pattern. The device or stent may comprise a helical, or other shape, having the laser cut geometry or pattern imparted thereon. The device or stent may further comprise drugs or bio-active agents incorporated into or onto the device or stent in greater percentages than conventional devices or stents. Radiopaque materials may be incorporated into, or coated onto, the intraluminal device or stent. Precise geometries or patterns are simply and readily achievable using the laser cutting methods in the presence of an inert gas while minimizing damage to the precursor materials.

Description

INTRALUMINAL MEDICAL DEVICES CUT TO LASER BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The invention relates generally to bioabsorbable interluminal medical devices that are laser cut in an inert gas atmosphere to impart a desired geometry or pattern to the device.

RELATED TECHNIQUE Intraluminal endovascular medical devices, such as stents, are well known. Such stents are often used to repair narrowed or occluded blood vessels from diseases, for example, for use within other or ducts or passages of the body. Typically the stent is percutaneously routed to a treatment site and expanded to maintain or establish the permeability of the blood vessel or other passages or ducts within which the stent is emplaced. The stent may be the self-expanding stent comprising materials that expand after insertion in accordance with the patient's body temperature or the stent may be independently expanded by a radial force directed outward from a balloon, for example, with what the strength of The balloon is exerted on an interior surface of the stent to expand the stent to an inner surface of the vessel or other passage or duct within which the stent is placed. Normally, once placed inside the vessel or other passage or duct, the stent will adapt to the contours and functions of the blood vessel or other body passage in which the stent is deployed. Even more, as in the patent of E.U.A. No. 5,464,450, it is known that stents comprise biodegradable materials, whereby the main body of the stent is degraded in a controlled and predictable manner. Stents of this type can further comprise drugs or other biologically active agents that are contained within the biodegradable materials. Thus, drugs or other agents are released as biodegradable materials from the degradation of the stent. Although such biodegradable drug-containing stents as described in the patent of E.U.A. No. 5,464,450 can be formed by mixing or solubilizing the drugs with the biodegradable polymer comprising the stent, by dispersing the drug in the polymer during extrusion of the latter or by coating the drug on an already formed film or fiber, such stents typically include relatively small amounts of drugs. For example, the patent of E.U.A. No. 5,464,450 contemplates in its stent only up to 5% of aspirin or heparin for delivery from it. In addition, such stents, as described in the patent of E.U.A. No. 4,464,450, are often made without radiopaque markers. The omission of radiopaque markers inhibits the visualization and precise placement of the stent by the attending physician. The polymers are often processed under molten conditions and at temperatures that may be higher than adequate for stability of the drugs or other agents to be incorporated into a bioabsorbable drug delivery device. Typical methods for preparing biodegradable polymeric drug delivery devices such as stents include fiber spinning, film or tube extrusion or injection molding. All these methods tend to use processing temperatures that are higher than the melting temperature of the polymers. The processing of such conditions tends to compromise the physical properties of the materials comprising the stent. Furthermore, most bioabsorbable polymers melt in process at temperatures greater than 130 ° -160 ° C, which represents temperatures at which most drugs are no longer stable and tend to degrade. Stents of different geometries are also known. For example, stents like the one described in the patent of E.U.A. No. 6,423,091 is known to comprise a helical pattern comprising a tubular member having a plurality of longitudinal struts with opposite ends. No preceding technique described combines techniques to provide a bioabsorbable intraluminal medical device, such as a stent, which is formed using laser-cutting techniques with mask projection to provide an intraluminal device or stent of desired geometry or patterns that has a greater capacity for drug delivery and radiopacity and simultaneously minimizes damage to the materials comprising the device or stent during processing. In view of the foregoing, there is a need for systems and methods that form implantable bioabsorbable polymeric drug delivery devices with desired geometry or patterns, wherein the devices have a greater and more effective capacity for drug delivery and radiopacity. In addition, by virtue of the foregoing, there is a need for systems and methods that simplify the machining and forming of said bioabsobible laser-cut intraluminal devices or stents.

BRIEF DESCRIPTION OF THE INVENTION The systems and methods of the invention provide a bioabsorbable intraluminal stent or device that is implanted within the vasculature or other passage of a patient. The device or stent is laser-cut in an inert gas atmosphere in desired geometries or patterns. The device or stent is formed in an appropriate manner, such as helical or other shape, which carries its location in a vessel or other atomic passage of a patient. The techniques for laser cutting a precursor material in the presence of inert gas simplifies and facilitates precise geometries or patterns, without compromising the resistance or performance of the intraluminal device or stent. The device or stent it preferably further comprises drugs or other bioactive agents incorporated in or applied to the device or stent in greater percentages than those normally provided in conventional devices or stents. The radiopaque material may further comprise the intraluminal device or stent, wherein said radiopaque material is incorporated into or applied to the materials comprising the device or stent. Drugs, bioactive agents or radiopaque materials can be provided before or after laser cutting of the precursor material and formation of the device or stent. In some embodiments of the systems and methods of the invention, the materials from which the intraluminal device or stent is made are provided from a precursor sheet of bioabsorbable materials, wherein the desired geometry or pattern is laser cut at the precursor sheet and the sheet is wound into a helical or other shape. The precursor sheet is produced from conventional compression molding or solvent casting techniques, for example. In other embodiments of the systems and methods of the invention, the materials from which the intraluminal device or stent is made, are provided from a precursor tube of bioabsorbable materials. The precursor tube is produced from conventional melt extrusion and solvent based processes, for example. The desired geometry or pattern is laser cut into the precursor tube.

In practice, the precursor plate or tube of bioabsorbable material is mounted to a laser processing unit and is energized from a laser beam to form an implantable device or stent having the desired geometry or pattern imparted thereon. An inert gas is provided within the atmosphere in which the laser cut occurs. A mask, having the desired geometry or pattern ultimately imparted to the device or stent, is provided on top of the bioabsorbable material and the laser beam to assist in imparting the intended geometry or pattern to the precursor material by the laser beam. The laser processing unit preferably comprises a coordinated multimode unit that moves the laser beam in one direction and the material in another direction when the material is subjected to the laser beam for cutting the material of the precursor material. The laser beam projects through the mask and ablates the bioabsorbable material, imparting to the device or stent the geometry or pattern that corresponds to the mask. The inert gas provided in the laser cutting environment minimizes, or ideally eliminates, the effects related to humidity and oxygen during laser cutting of the material. Preferably, the laser beam is further directed through a lens before reaching the precursor material. The lens intensifies the beam and imparts more precisely the desired pattern or geometry on the materials. A beam homogenizer can also be used to create a more uniform laser beam energy and maintain the energy consistency of laser beam when the beam hits the material. In this way, the laser-machined features are achieved more simply and easily in the desired geometry or pattern. The beam energy can be controlled to reduce the laser cutting time. After laser cutting the desired geometry or pattern or precursor material, the precursor material is removed from the laser cutting unit and stored until needed, in the case of the tube, or formed in the desired configuration, ie helical or other, and then stored until necessary. Varying size precursor materials can be laser cut using the techniques described herein to provide intralummal medical devices or stents having various axial and radial resistances and flexibility, or other features, to better adapt to various medical and physiological needs. The geometries or patterns imparted the precursor material may comprise helical, non-helical or combinations thereof, which extend mostly in part or at discrete intervals of the length of a device or stent formed at the end. These and other features of the invention, including various novel construction details and combinations of parts, will now be described more in particular with reference to the drawings and appended claims. It will be understood that the various example embodiments of the invention described herein are shown as illustration only and not as limitation. this. The features and principles of this invention are employed in various alternative embodiments without departing from the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS These and other features, aspects and advantages of the apparatus and methods of the invention will be better understood with respect to the following description, accompanying clauses and accompanying drawings in which: Figure 1 illustrates a precursor sheet of the bioabsorbable material according to the systems and methods of the invention. Figure 2 illustrates a precursor tube of bioabsorbable material according to the systems and methods of the invention. Figure 3 illustrates a laser processing unit for laser cutting the precursor sheet of Figure 1 or the precursor tube of Figure 2 according to the systems and methods of the invention. Figure 4 illustrates a partial view of the laser processing unit of Figure 3 including a mask through which the laser beam penetrates to impart a geometry or pattern onto a precursor sheet or tube in accordance with the systems and methods of the invention. invention. Figures 5A-5C illustrate portions of helically wound stents having a laser-cut geometry or pattern from a precursor sheet in accordance with the systems and methods of the invention.

Figure 6 illustrates portions of a stent having a laser cut geometry or pattern from a precursor tube in accordance with the systems and methods of the invention. Figures 7A-7C illustrate stents having laser-cut geometries or patterns from a precursor tube in accordance with the systems and methods of the invention. Figures 8A-8C illustrate various other geometries and patterns laser cut from a precursor material according to the systems and methods of the invention.

DETAILED DESCRIPTION OF THE INVENTION Figure 1 illustrates a precursor sheet 100 of bioabsorbable material for forming an intraluminal medical device or stent according to the systems and methods of the invention. The precursor sheet 100 is produced from conventional compression molding or solvent casting techniques, for example, which are not detailed further here since the skilled person should readily understand how such precursor sheets 100 are formed using conventional techniques. The precursor sheet 100 is provided with dimensions of length (I), width (w) and thickness (t) which can vary from sheet to sheet to suit the formation of medical devices or stents of different size. For example, when a longer anatomical vessel or passage is the intended treatment site, then it can be providing a longer length dimension (I) or when a greater radial strength is desired, then a larger thickness dimension (t) may be provided. The precursor sheet 100 comprises bioabsorbable materials such as, for example, aliphatic polyesters (polylactic acid, polyglycolic acid, polycaprolactone, polydioxanone, polytrimethylene carbonate, polyoxaesters, polyoxamides and their copolymers and mixtures, polyanhydrides include polycarboxyphenoxy hexansebacic acid, polyfoaric acid-sebacic acid, polycarboxyphenoxy hexane-sebacic acid), polyimide-sebacic acid ((50-50) and polyimide-carboxyphenoxy-hexane (33-67), poly (orthoesters (diketene-acetal-based polymers), polyamino acid tyrosine-derivative [examples: DTH polycarbonates, polyarylates and polyiminocarbonates)], phosphorus-containing polymers [eg, polyphosphoesters and polyphosphazenes]], block copolymers based on polyethylene glycol [PEG] [PEG-PLA, PEG-poly (propylene glycol), PEG-polybutylene terephthalate)], poly (a-malic acid), amide polyester and polyalkanoates [for example: polyhydroxybutyrate (HB) and polyhydro copolymer Droxivalerate (HV)]. Of course, the skilled artisan will appreciate that other known or further developed bioabsorbable materials are contemplated which lead to implantation within vasculature or anatomical passages of a patient and which comprise the medical device or stent formed in accordance with the systems and methods according to the invention. The bioabsorbable materials comprising the precursor sheet 100 and the dimensions thereof, contribute to axial and radial resistance and to the flexibility characteristics of the device or stent. Figure 2 illustrates a precursor tube 200 of bioabsorbable material according to the systems and methods of the invention. The precursor tube 200 is produced from conventional melt extrusion and solvent-based processing techniques, for example, which are not detailed here since the person skilled in the art should observe how such precursor tubes 200 are formed using conventional techniques. The precursor tube 200 is provided with dimensions of length (I), diameter (d) and weight (t) which can vary from tube to tube to adapt to the formation of medical devices or stents of different size. Precursor tubes 200 preferably comprise materials bioabsorbable, as described above with respect to the precursor sheets 100, whose materials, and their dimensions, contribute to the axial and radial resistance of the flexibility characteristics of the device or stent. Figure 3 illustrates a laser processing unit 1000 for laser cutting the precursor material according to the systems and methods of the invention The precursor material is already s Either the precursor sheet 100 of FIG. 1 or the precursor tube 200 of FIG. 2. The laser processing unit 1000, which is a non-restrictive example of a laser processing unit for laser cutting precursor material according to the various embodiments described. here, it comprises a stage X 1001, a stage Y 1002 and a stage Z 1003, wherein each stage moves independently a of the other. A laser beam 1010, shown in dashed lines in Figure 3, is provided within the housing 101 1, for example, that at least one of the stage X 1001, stage Y 1002 and stage Z 1003 is fixed. Figure 3 illustrates the housing 101 1 as fixed to the step Y 1002, for example, wherein the laser 1010 is housed there. In practice, the precursor sheet 100 is disposed in the stage X 1001 below the range of movement of the laser beam 1010. When a precursor tube 200 is used, the laser processing unit 1000 further comprises a rotating stage 1004 having an apron 1005 that extends from there. In practice, the precursor tube 200 is arranged on the mandrel 1005 below the range of motion of the laser beam 1010, wherein the rotating stage 1004 and the mandrel 1005 independently rotate the precursor tube 200 mounted therein. Thus, when a planar precursor sheet 100 is used, the rotating stage 1004 and mandrel 1005 of Figure 3 can be omitted and the precursor sheet 100 is positioned along the stage X 1001. In any case, the laser beam 1010 is moved in relation to the precursor material and preferably the precursor material also moves relative to the laser beam 1010, to direct the energy of the laser beam on the precursor material. As illustrated in Figure 3, the laser processing unit 1000 also comprises an inert gas box 1015 surrounding the precursor material (sheet 100 / Figure 1 or tube 200 // Figure 2) during the laser cutting process. The inert gas box 1015 includes an inlet 1016 and an outlet 1019 through which the inert gas flow enters respectively and leaves the inert gas box 1015. The inlet 1016 can be further connected to a supply of inert gas 1018 through a hose 1017 or other means for supplying the inert gas to the inert gas box 1015. The inert gas helps to minimize, or ideally removing imperfections or other undesirable defects in the precursor material that is subject to the laser cutting techniques described herein. The inert gas can be, for example, nitrogen. The skilled person will readily appreciate that other laser processing units can be configured differently, although comprising the same features described herein, wherein the laser beam moves relative to the precursor material and preferably the precursor material also moves relative to the laser beam. As shown in Figure 3, the stage Y 1002 is shown as having the laser beam 1010 disposed therewith within the housing 1010, although the skilled person should appreciate that any or all of the steps could also have a laser beam attached thereto or omitted from it, provided that at least one laser beam is provided. In addition, although the laser processing unit 1000 shown in Figure 3 illustrates a unit having movement in three directions, namely the x, y and z direction, the skilled person should note that the laser processing units have other capabilities of directional movement and that they are also contemplated to make devices according to the systems and methods according to the invention. For example, a coordinated 6-axis motion laser processing unit can be used with which the precursor material is moves in one direction while the laser beam moves in an opposite direction to impart the intended geometry or pattern to the material. Fig. 4 illustrates a partial view of the step Y 1002 of the laser processing unit 1000 of Fig. 3 having a flat precursor sheet 100 disposed thereunder for laser cutting. The cover Y 1002 in this case comprises the housing 101 1 in which the laser beam 1010 (dotted lines) is arranged. The housing 1011 also comprises a lens 1030 and a mask 1020 disposed therein, through which lens 1030 and mask 1020 the laser beam 1010 projects to impart a geometry or pattern on the precursor material, such as a precursor sheet 100 or tube 200. In particular, the mask 1020 includes the geometry or pattern 1021 imparted to the underlying precursor sheet 100 or tube 200 when the laser beam 1010 projects through the mask 1020 and over the protective material Although Figure 4 is shown as having a geometry or pattern 1021 of a series of generally longitudinally adjacent segments, the skilled artisan will observe that the geometry or pattern 1021 imparted to the precursor material is altered to suit medical and physiological needs. Accordingly, changing the mask 1020 to one having a different geometry or pattern imparts the different geometry or pattern to the precursor material, wherein a uniform geometry or pattern is imparted to the precursor material or different geometries or patterns can be imparted to the precursor material . Figures 5A-5C-8C illustrate various non-restrictive geometries or patterns 1021 that are imparted to materials precursors for understanding devices or stents according to the various modalities described herein. Other known geometries or patterns subsequently developed that lead to displacement or compatibility within the vasculature or other anatomical passage of a patient can be laser cut from a precursor material to form a device or stent as described herein, including exclusively helical designs. (Figure 8A), non-helical designs 800 (Figure 8B) having one or more longitudinally adjacent segments or combinations of these 900 (Figure 8C). The designs may extend the entire length of the device or stent when they are formed after the laser cut thereof or may extend only partially along the length of the device or stent after the laser cut of the latter., or they may extend at discrete intervals along the length of the device or stent after laser cutting thereof. Preferably, as also shown in Figure 4, the laser processing unit 1000 also comprises a lens 1030 through which the laser beam passes to intensify the energy of the beam 1010 and to shrink or concentrate the geometry or pattern of the target precursor material. . Although Figure 4 illustrates the lens 1030 positioned above the mask 1020, the skilled artisan will observe that the lens 1030 could alternatively be positioned below the mask 1020, to intensify the energy of the beam 1010 when it hits the precursor material. The three-dimensional machining of devices or stents that have geometries or patterns oriented with precision it is simplified as a result of imparting the geometries or patterns to them using the laser processing techniques described herein. Although not shown, a beam homogenizer can also be used to create a more uniform laser beam energy density applied to the target precursor material, ideally to achieve features machined more consistently in the device or stent. In this sense, the laser beam 1010 is thus formed prior to reaching the mask 1020, which can help to optimize the production of the designed device or stent In practice, typical conditions used to prepare the device or stent according to the systems and methods of the invention include projecting a laser beam 1010 through the lens 1030 (the beam homogenizer if provided) and the mask 1020 at a wavelength of 193 nm with an energy density of 580-600 mJ / cm2, where the laser repetition rate is within the range of 80-175 Hz, and the number of laser pulses is within the range of 390-1000 The wavelength 193 nm tends to provide cleaner edges with less thermal damage to the underlying precursor materials. The wavelength 193 nm also tends to provide higher resolutions that are more easily adapted to impart more complicated designs, geometries or patterns to the stent or device than the standard or longer wavelengths. Inert gas, like nitrogen, is used in the laser cutting atmosphere to reduce the minimum, or ideally, eliminate the effects related to humidity and oxygen during laser cutting. According to the various embodiments described herein, a polymeric precursor material is thus converted into a device or stent by laser cutting, for example by eximer laser cutting, or micromachining, the precursor material, in the presence of an inert gas by minimizing the damage to the physical properties of the precursor material. Performing laser cutting of the precursor material in the presence of the inert gas tends to minimize undesirable damage to the precursor material during processing as compared to other methods such as injection molding, extrusion or other conventional techniques. Furthermore, the laser cutting techniques described herein are of relatively short duration, for example 2-3 minutes and simple to perform compared to more conventional techniques. The flat precursors (figure 1) tend to take less time to process compared to tubular precursors (figure 2), although the laser cut either precursor, ie a flat precursor or a tubular precursor, according to the systems and methods described here tend to take less time (2-3 minutes) than conventional techniques (typically around 5-15 minutes). Furthermore, the energy of the laser beam can be controlled to vary the laser cutting time. For example the laser beam energy can be raised to decrease the laser cutting time, the laser beam energy can be lowered to increase the laser cutting time, the resistance or orientation of the lens They can be altered or the materials can be altered to control the laser cutting time. Even further, the devices or stents made in accordance with the various embodiments described herein contain drugs or other bioactive agents in greater percentages by weight than conventional metal stents coated with drug. For example, devices or stents made in accordance with the various embodiments described herein may comprise drugs or bioactive agents on a scale between 1-50% by weight, and preferably between 10-30% by weight. Drugs or other bioactive agents can be incorporated into or applied to the precursor material prior to laser cutting or prior to being incorporated into or applied to the device or stent after laser cutting and laser formation. Ideally, the drug content provided in devices or stents made in accordance with the modalities described herein remains and is substantially unaffected by laser cutting thereof. Such drugs or other bioactive agents can be for example, therapeutic agents and pharmaceuticals including: antiproliferative / antimitotic agents including natural products such as vinca alkaloids (ie vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (ie etoposide, teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin e Darubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mitramycin) and mitomycins, enzymes (L-asparaginase that metabolizes L-systemically) asparagine and restricts cells that do not have the ability to synthesize their own asparagine); antiplatelet agents such as G (GP) IIb / Illa inhibitors and vitronectin receptor antagonists; anti-proliferative / antifungal alkylating agents such as nitrogen mustards (mechlorethamine, cyclophosphamide and the like, melphalan, chlorambucil), ethylene imines and methylmelamines (hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine (BCNU and analogues, streptozocin), trazenos-dacarbazinine (DTIC) antiproliferative / antimitotic antimetabolites such as analogues of phytic acid (methotrexate), pyrimidine analogs (fluorouracil, floxuridine and cytarabine) purine analogues and related inhibitors (mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine. ), coordination complexes of platinum (cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide, hormones (ie estrogens), anticoagulants (heparin, synthetic heparin salts and other thrombin inhibitors), fibrinolytic agents (as a plasminogen activator) of tissue, streptokinase and urokinase), aspirin, dipyrid amol, ticlopyrine, clopidogrel, abciximab; anti-migratory; antisecretory (breveldine); antiinflammatories such as adrenocortical spheroids (cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6a-methylprednisolone, tnamcinolone, betamethasone, and dexamethasone), non-steroidal agents (derivatives of salicylic acid ie aspirin, paraaminophenol derivatives ie acetaminophen, indole and acetic acids of indene (indomethacin, sulindac, and etodalec), heteroaryl acetic acids (tolmentin, dichlorophena and ketorolac), arylpropionic acids (ibuprofen and derivatives), anthraquinic acids (mefenamic acid, and meclofenamic acid), enochonic acids (piroxicam, tenoxicam, phenylbutazone and oxifentatrazone), nabumetone, gold compounds (auranofin, aurothioglucose, sodium thiomalate and gold); immunosuppressants: (ciclosponna, tacro mus (FK-506), sirohmus (rapamycin), azathioprine, mycophenolate mofetil); angiogenic agents, endote vascular growth factor (VEGF), fibroblast growth factor (FGF); angiotensin receptor blockers, nitric oxide donors, antisense oligonucleotides and combinations thereof, cell cycle inhibitors, mTOR inhibitors, and inhibitors of growth factor receptor signal transduction kinase, retenoids, cyclin / CDK inhibitors; Coenzyme HMG reductase inhibitors (statin), and protease inhibitors Radiopaque marker materials may also be incorporated into or applied to all or part of the precursor material prior to laser cutting or may be incorporated into or applied to all or part of the device or stent after cutting laser and formation of this has occurred The radiopaque material must be biocompatible with the tissue in which the device is deployed Such biocompatibility minimizes the likelihood of undesirable tissue reactions with the device. Radiopaque additives may include metal powder such as tantalum or gold, or metal alloys having gold, platinum, iridium, palladium, rhodium, a combination of these or other materials known in the art. Other radiopaque materials include barium sulfate (BaS0). , subcarbonate bismuth ((Bio) 2C03), bismuth oxide and / or iodine compounds. Ideally, the radiopaque materials should preferably adhere well to the surface so that the detachment or delamination of the radiopaque material from the device is minimized or ideally does not occur. When the radiopaque materials are added to the device as metal bands, the metal bands can be corrugated into designated sections of the device. Alternatively, designated device sections can be coated with a radiopaque metal powder, while other portions of the device are free of the metal powder. Even more alternately, sections of the device can be laser cut in a cavity 701, FIG. 8A, for example, which is subsequently filled with radiopaque material. Of course, the cavity 701 may be made in locations or in forms other than that shown and may be a part of any of the various device designs or stents described herein. As the expert will observe, barium is often used as the metallic element to visualize the device using these techniques, although they are being used more and more and other fillers. The particle size of the radiopaque materials can be in the range of nanometers to microns and the amount of opaque materials can be in the range of 1-50% (% p). Figures 5A-5C illustrate portions of helically wound stents 300 having a laser cut geometry or pattern from a precursor sheet of bioabsorbable material according to the various embodiments described herein. Figures 5A-5C demonstrate stents of different dimensions or materials that have varied radial resistance characteristics. For example, coiled helical stents 300 were laser cut in the presence of an inert gas using a laser processing unit as the laser processing unit 1000 of Figures 3 and 4. After cutting, the precursor material is removed from the unit of laser processing and is wound around a mandrel, or manipulated in another way, to make the helical shape. The radial resistance of the stents of Figures 5A-5C were on the scale of 0.14 to 2.10 kg / cm2, depending on the thickness of the precursor material used and the opening of the geometry or pattern imparted to the stents. Figures 5A-5C illustrate portions of helical stents 300 of various dimensions in length and of the same diameter, wherein each is formed from different combinations of bioabsorbable materials. For example, Figure 5A illustrates a helically wound stent 300 with a length of 18 mm and an inner diameter of 3.5 mm; Figure 5B illustrates a helical stent 300 with a length of 10 mm and an inner diameter of 3.5 mm; and Figure 5C illustrates a helical stents 300 with a length of 18 mm and an inner diameter of 3.5 mm. Various bioabsorbable materials comprising PLLA, PLGA (95/5), PLGA (85/15) and PCL / PGA (35/65) were used to comprise the stents. Based on Figures 5A-5C, the stents made of PLLA and PLGA tended to have better radial strength than the other test materials, regardless of the length dimensions of the stent or device. Of course, the dimensions identified Above they can vary and can be extended according to physiological needs. Figure 6 illustrates other stents 400 made in accordance with the laser processing techniques of the invention whereby the stent 400 is fabricated from a precursor of bioabsorbable material. Figure 6 illustrates, for example, a stent 400 having a Bx VELOCITY® (stent) design with a length of 18 mm, and an internal diameter scale of 1-4 mm. The precursor material thicknesses ranged from 76 to 254 microns and various bioabsorbable materials were used, for example, PLLA, PLLA / TMC blend, PLLA / PCL blend, PCL / PGA (35/65) and PLDL. Based on FIG. 6, the stents made of PLLA and PLDL tended to have better radial strength than the other test materials, regardless of the thickness dimensions of the precursor materials of the device or stent. Of course, the dimensions identified above may vary and may be extended according to physiological needs. Figures 7A-7C illustrate several non-restrictive examples of geometry or patterns imparted to a precursor to form a device or stent in accordance with the systems and methods of the invention. Figure 7A illustrates a stent 400 having a Bx VELOCITY® (stent) design; Figure 7B illustrates a stent 500 having a S.M.A.R.T.® (stent) design and Figure 7C illustrates a stent 600 having a PALMAZ® (stent) design. Of course, the dimensions may vary and may be extended according to physiological needs.

The various exemplary embodiments of the invention as described above do not limit different embodiments of the systems and methods of the invention. The material described herein is not limited to the materials, designs, or shapes referred to herein for illustrative purposes only and may comprise various other materials, designs or forms suitable for the systems and methods described herein, as will be observed by an expert. . Although it has been shown and described what are considered preferred embodiments of the invention, it will of course be understood that various modifications and changes in form or detail could be made without departing from the essence or scope of the invention. Therefore, it is intended that the invention not be limited to the exact forms described and illustrated herein, but that they be construed to cover all modifications that may fall within the appended claims.

Claims (10)

1. NOVELTY OF THE INVENTION CLAIMS 1. - A method for forming a laser-cut interluminal device using a coordinated motion laser processing unit, the method comprising: providing a precursor material; arranging the precursor material in relation to the laser processing unit; subjecting the precursor material to energy of a laser beam in the presence of an inert gas; impart a geometry and pattern to the precursor material; and removing the precursor material from the arrangement with the laser processing unit.
2. 2. The method according to claim 1, further characterized in that it also comprises: providing a mask with the laser processing unit with coordinated movement, whereby the laser beam is projected through the mask to impart the geometry and pattern to the precursor material.
3. 3. The method according to claim 2, further characterized in that providing the precursor material comprises providing a bioabsorbable material.
4. 4. The method according to claim 1, further characterized in that it also comprises: providing a lens with laser processing unit, through whose lens the laser beam passes to intensify the energy of the laser beam directed to the precursor material.
5. 5. The method according to claim 4, further characterized in that it also comprises: providing a beam homogenizer and shaping the laser beam prior to the laser beam projecting through the mask and the precursor material.
6. 6. The method according to claim 4, further characterized in that it also comprises: projecting the laser beam through the mask and the precursor material at a wavelength of 193 nm, with an energy density of 580-600 mJ / cm2 to impart the geometry and pattern to the precursor material.
7. 7. The method according to claim 6, further characterized in that it also comprises: a laser repetition rate of about 80-175 Hz and a series of laser pulses of about 390-1000 to impart the geometry and pattern to the precursor material .
8. 8. The method according to claim 1, further characterized in that it also comprises: minimizing the effects of moisture and oxygen during laser cutting of the precursor material by the presence of the inert gas.
9. 9. The method according to claim 1, further characterized in that the inert gas is nitrogen.
10. 10. The method according to claim 1, further characterized in that the precursor material is formed in a configuration that has the geometry and pattern imparted on them after the laser cut. 1 - The method according to claim 1, further characterized in that the precursor material is a tube having the geometry and pattern imparted thereto after laser cutting. 12. The method according to claim 1, further characterized in that providing the precursor material also comprises providing a drug or bioactive agent in any or all of the precursor materials prior to laser cutting. 13. The method according to claim 12, further characterized in that the drug or bioactive agent comprises 1-50% and preferably 10-30% by weight of the device. 14. The method according to claim 1, further characterized in that it also comprises: providing a drug or bioactive agent in or on some of the precursor material before laser cutting thereof. 15. The method according to claim 1, further characterized in that it also comprises: providing a radiopaque material in or on part or all of the precursor sheet prior to laser cutting thereof. 16. The method according to claim 1, further characterized in that it also comprises: providing a material radiopaque in or on all or part of the precursor material after laser cutting of this 17 - The method according to claim 1, further characterized in that imparting the geometry and pattern comprises imparting a helical design to the precursor material by laser cutting thereof. 18 - The method according to claim 1, further characterized in that imparting the geometry and pattern comprises imparting a non-helical design to the precursor material by laser cutting thereof 19 - The method according to claim 1, further characterized by imparting the geometry and pattern comprises imparting a combination of a helical and non-helical design to the precursor material by laser cutting this 20 - The method according to claim 1, further characterized in that imparting the geometry and pattern comprises imparting the geometry and pattern onto one of a total length of the intraluminal medical device, a portion of the entire length thereof or at intervals along the entire length thereof 21 - The method according to claim 1, further characterized in that the device is a stent 22. - The method according to claim 13, further characterized in that the% by weight of the drug or bioactive agent is substantially unaffected by laser cutting of the precursor material. 23. An intraluminal medical device comprising: a bioabsorbable precursor material having a geometry or pattern imparted thereto by laser cutting in the presence of an inert gas; at least one drug or bioactive agent incorporated in or on the device; and at least one radiopaque material incorporated in or on the device. 24. The intraluminal medical device according to claim 23, further characterized in that the precursor material is a sheet formed in a configuration for intraluminal reception after the geometry or pattern has been imparted thereto. 25. The intraluminal medical device according to claim 23, further characterized in that the precursor material is a tube. 26. The intraluminal medical device according to claim 23, further characterized in that the geometry or pattern is a helical design. 27. The intraluminal medical device according to claim 23, further characterized in that the geometry or pattern is a non-helical design. 28. - The intraluminal medical device according to claim 23, further characterized in that the non-helical design is a signal of longitudinally adjacent segments. 29. The intraluminal medical device according to claim 23, further characterized in that the geometry or pattern is a combination of helical and non-helical designs. 30. The intraluminal medical device according to claim 23, further characterized in that the geometry or pattern extends fully, partially or in discrete segments of a length of the device. 31. The intraluminal medical device according to claim 23, further characterized in that the at least one drug or bioactive agent is provided between 1-50% by weight. 32. The intraluminal medical device according to claim 31, further characterized in that the at least one drug or bioactive agent is provided between 10-30% by weight. 33. The intraluminal medical device according to claim 31, further characterized in that the% by weight of the at least one drug or bioactive agent is substantially unaffected by the laser cut of the device. 34. The ntraluminal medical device according to claim 22, further characterized in that the device is a stent.