MXPA97001089A - Vibratory endoprotesis to open calcifica injuries - Google Patents

Abstract

A system for supplying stent and intraluminal catheter that uses vibratory energy to open calcified lesions. The catheter has an expandable stent mounted on a balloon portion, adapted to convey vibratory energy through the stent to a calcified region to facilitate, cross and dilate the lesion during a PTCA procedure. A source of vibratory energy is transmitted through a flexible wire to provide vibratory energy to the stent, which in turn provides vibratory energy to a calcified lesion, in order to at least partially pulverize the lesion and assist in crossing and dilating the lumen corpor

Description

VIBRATORY ENDOPROTESIS TO OPEN CALIFIED INJURIES BACKGROUND OF THE INVENTION The invention relates generally to transcutaneous coronary angioplasty (PTCA), where a dilatation catheter is used to cross a lesion and dilate the area of injury to restore blood flow to the artery. More specifically, the invention relates to a catheter and stent assembly adapted to produce vibratory energy and aid in crossing and dilating calcified lesions.In typical PTCA procedures, a guide catheter having a preconfigured distal tip is introduced percutaneously into the system. A patient's cardiovascular system is advanced until a pre-configured distal tip is disposed within the aorta adjacent to the ostium of the desired coronary artery.The guide catheter is twisted or twisted from the proximal end to rotate the Distal tip of the catheter guide so that it can be guided inside of the coronary ostium A dilatation catheter having a balloon at its distal end and a guidewire disposed unequally within an inner lumen of the dilatation catheter are introduced into and advanced through the catheter guiding its distal tip. The distal tip of the guidewire is usually manually configured (i.e., curved) before the guide wire is inserted into the guide catheter together with the dilatation catheter. The guide wire is first advanced out of the distal tip of the glide catheter into the coronary artery. patient, and twisting torque is applied to the proximal end of the guidewire, which extends outwardly of the patient, to guide the curved distal end or otherwise configured guidewire, as the guide wire is advanced into the coronary anatomy until that the configured distal end of the guide wire enters the desired artery. The advancing guiding wire within the selected artery continues until its distal end crosses the lesion to dilate. The dilatation catheter is then advanced out of the distal tip of the guide catheter over the previously advanced guidewire, until the balloon at the distal extremity of the dilatation catheter is properly positioned through the lesion. Once properly positioned, the balloon dilatation is inflated to a predetermined size with radiopaque liquid at relatively high pressures (for example 3.9-11.84 bar (4 to 12 atmospheres)) to dilate the stenotic region of the diseased artery. The balloon then deflates so that the dilatation catheter can be removed from the dilated stenosis and blood flow through the dilated artery can be resumed. More details of catheters guide, catheters of Dilatation, guidewires and other devices for angioplasty procedures can be found in U.S. Pat. No. 4,323,071 (Simpson-Robert); the U.S. Patent No. 4,439,185 (Lundquist); the U.S. Patent No. 4,468,224 (Enzmann et al.); the U.S. Patent Do not. 4,516,972 (Samsoh); the U.S. Patent No. 4,438,622 (Samson et al.); the U.S. Patent No. 4,582,185 (Samson); the U.S. Patent No. 4,616,652 (Simpson); the U.S. Patent No. 4,638,805 (Powell); the U.S. Patent Do not. 4,748,986 (Morrison et al.); the U.S. Patent No. 4,898,577 (Badger et al.); and the U.S. Patent. No. 4,827,943 (Taylor et al.). Several notable improvements have recently been made in balloon angioplasty catheters. A modification, commonly referred to as a rapid exchange catheter, is described in US Pat. No. 4,748,982 (Horzewski) wherein an inner lumen or short sleeve at least about 10 cm long is provided within the distal section of the catheter body extending from a first gate proximal to the balloon to a second gate at the end dist *** l of the catheter and which is adapted to slidably receive a guidewire. The proximal gate is not less than about 10 cm and not more than about 40 cm from the distal end of the catheter. Preferably, a groove is provided in the catheter body extending from the gate proximal to a location proximal to the proximal end of the balloon, to facilitate catheter removal from the proximal end of the guidewire extending outward from the pattern.

Another modification, which was introduced into the market by the assignee of the present application (Advanced Cardiovascular Systems, Inc.), are dilatation-type perfusion catheters that allow for long-term dilatations. to repair arterial dissections and other arterial damages. These perfusion catheters have a plurality of perfusion gates in the wall that form at least a portion of the catheter body proximal to the balloon, which is in fluid communication with an inner lumen extending to the distal end of the catheter body. A plurality of perfusion ports is preferably provided in the catheter body distal to the balloon which is also in fluid communication with the inner lumen extending to the distal end of the catheter body. When the balloon at the distal end of the dilatation catheter is inflated to dilate a stenosis, oxygenated blood is forced into the artery or aorta or both, depending on the location of the dilatation catheter within the coronary anatomy, to pass through. The proximal perfusion forces through the inner lumen of the catheter body and outward from the distal perfusion ports. This provides oxygenated blood downstream of the inflated balloon to thereby avoid or minimize ischemic conditions in tissue distal to the catheter, thereby facilitating long-term dilatations. As a result, care must be exercised in sizing the perfusion ports and the interior lumen to ensure that there is adequate flow of oxygenated blood to the distal tissue or catheter, to eliminate or minimize ischemic conditions. Commercially available infusion catheters, in general, have relatively large profiles due to the size of the inner tubular member extending through the interior of the balloon, which avoids its use in many distal coronary locations. A greater and continuous impulse in development work in the field of intravascular catheters, particularly coronary angioplasty catheters, has reduced the profile, ie transverse dimensions of the aforementioned catheters and improve their flexibility without adversely affecting the pushing ability, particularly in the distal portion of these catheters. A reduction in profile with little or no loss of thrust capability allows a dilatation catheter to advance much more in a patient's coronary vasculature and cross much narrower lesions. While the above methods and devices are suitable in most cases to perform PTCA, especially the low profile catheters of the prior art, there are certain conditions that prevent or at least make extremely difficult to perform PTCA procedures with devices of the prior art. previous technique For example, when the stenosis (or lesion) in the coronary artery is an almost total occlusion, or when the plaque becomes calcified and essentially blocks most of the blood flow, conventional guidewires and dilatation catheters are unable to cross the stenosis. Complications may also arise if the doctor tries to force the gluer wire or dilatation catheter through. of the plate. Very often, the plate only has an opening through which the blood circulates, but there are a number of fissures in the plate. If the doctor tries to force the wire through a tight injury, and instead the wire follows one of the fissures, then the artery can be perforated since the guide wire follows the fissure instead of the path of fl, μjo of blood. Whereas the guidewire and balloon can cross the stenosis, tight lesions may have calcium in them and typically require very high balloon pressures to "crack" the lesion and restore blood flow. Considering that the guidewire is able to cross a tight lesion, there is no guarantee that the dilatation catheter will be able to cross or even cross itIt can be difficult or dangerous for the patient to inflate the balloon at high pressures. Prior art devices do not offer a solution to this problem with tight lesions, apart from removing the wire and catheter and then considering alternative procedures such as cardiopulmonary bypass surgery. The present invention is designed to cross nearly occluded arteries and allow the balloon to expand a calcified lesion more easily and at lower pressures.

COMPLEX PE FACA INVENCIQH The invention provides a catheter and stent assembly adapted to open calcified lesions using vibratory energy. The intravascular catheter assembly of the invention includes an elongated tube member with proximal and distal ends and an expandable member (balloon) near the distal end. An intravascular stent is mounted on the balloon and folded down in a first collapsed condition. The balloon and stent are placed in a stenosed or contracted region that is difficult to cross and that is formed of a calcified or otherwise hardened plaque. A flexible elongate member, such as a wire, extends from outside the patient through the catheter, and its distal end is placed near or in contact with the stent. A vibrational energy source, external to the patient, provides vibration energy on the flexible wire to the stent. The vibratory energy transferred to the stent vibrates the hardened plate making it easy for the portion of the balloon-and-stent of the catheter assembly to dilate the lesion. The vibration can even partially break or pulverize the plate into small particles that will be dragged without damage with the increased blood flow. The vibratory energy can be supplied by ultrasound energy that provides waves of continuous energy, pulsed energy or irregular and non-repetitive energy, to the flexible wire and therefore to the stent. The source of vibratory energy can also be a mechanical device that produces sufficiently high energy vibrations to transmit energy on the flexible wire to the stent and thus to the plate region. It is convenient to removably connect the flexible wire to the stent, such that after the balloon and endograft has crossed the lesion and the stent has been implanted in the coronary artery, the wire can be detached from the catheter and stent assembly implanted with the stent. the wire removed from the patient. In one embodiment, the vibratory energy is generated by an auditory sound generating device that transmits sound waves through the inflation fluid in the catheter inflation lumen. After inflating fluid is injected into the inflation lumen and partially into the balloon / the audio energy source provides vibratory energy to the inflation fluid and therefore to the balloon and endograft & amp; there mounted. The vibratory energy again allows the balloon and stent to fissure the plaque and more easily dilate the lesion, and may even pulverize a portion of the plaque in the process. In the preferred method of using vibrational energy to aid in dilation of the stenosed region, the catheter with the endograft mounted therein is first placed within the stenosed region. A source of vibratory energy is delivered to the stent while in its collapsed condition, in the portion of the catheter balloon, thereby transmitting at least a portion of the vibratory energy through the stent and into the stenosed region. As the stenosed region begins to rupture and otherwise provide more than one opening for the distal end of the catheter and the stent, the catheter can be advanced distally such that the balloon and stent are placed completely within the stenosed region. A continuous supply of vibratory energy will facilitate the expansion of the balloon and stent and the opening of the body lumen to allow through blood flow. At the end of the procedure, the balloon portion of the catheter is deflated and the catheter and balloon are removed from the body lumen, leaving the stent implanted to assist in keeping the lumen open. These and other advantages of the invention will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying exemplary drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an elevational view, partially in section, of a dilatation catheter of the prior art known as a rapid exchange type catheter.

Figure 2 is an elevation view, partially in section of a dilatation catheter of the prior art having perfusion capabilities. Figure 3 is a cross-sectional view of a catheter and stent assembly embodying features of the invention. Figure 4 is a cross-sectional, transverse view of the catheter illustrated in Figure 3, taken on lines 4-4. Figure 5 is a cross-sectional, transverse view of the catheter illustrated in Figure 3, taken on lines 5-5. Figure 6 is a cross-sectional, transverse view of the catheter illustrated in Figure 3, taken on lines 6-6. Figure 7 is an elevational view, partially in section, of a rapid exchange type catheter incorporating characteristics of the invention. Figure 8 is an elevation view; partially in section of a rapid exchange type catheter illustrating a source of vibratory energy for vibrating an expandable stent. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Figure 1 illustrates a rapid exchange-type dilatation catheter of the prior art and is for use in PTCA procedures, which allow the exchange of a catheter while the guidewire remains in place within the system of a patient, to avoid loss of arterial position. This dilatation catheter is usual for the types of catheters used to open narrow lesions or partially fluid lesions. Another catheter of the prior art as illustrated in Figure 2, also opens tight lesions and has the added feature of being able to perfuse blood while the balloon portion of the catheter expands during the PTCA procedure. When prior art catheters are unable to expand or open a hardened or clenched lesion, then the present invention can be employed. With reference to Figures 3 to 7, a preferred embodiment of the catheter and stent system using vibratory energy is illustrated. Catheter 10 generally comprises an elongated catheter shaft 11, an inflation lumen 12 adapted to direct inflation fluid from the proximal end of the catheter shaft into an inflatable balloon 13, at a distal portion of the catheter shaft and an inner guide wire lumen 14, which extends there from the proximal end of the catheter shaft to a first guide wire gate 15 at the distal end of the catheter shaft. A second guide wire gate 16 which is also in communication with the guide wire lumen 14, is provided in the wall forming at least in part the arrow of the catheter 11 at a site of approximately 10 to 50 cm from the distal end of the catheter. the arrow of the catheter and a substantial distance from the end near the arrow of the catheter. As illustrated in Figures 3 to 7, the proximal section 17 and the distal section 18 of the catheter shaft 11 are of a dual lumen construction, with the inflation lumen 12 and a guidewire lumen 14 having sections circular cross sections. The inflation lumen ends at the proximal end of balloon 13 and is in fluid communication with the interior of the balloon. A tubular extension 20 of the catheter shaft 11, which partly defines the guide wire receiving lumen 14, extends to the distal end of the catheter shaft 11. The distal end of the balloon 13 is sealable with the distal end. of extension 20 by convenient means such as thermal bonding or an adhesive. The inflation lumen within the proximal section 17, preferably is provided with an inner tubular support member 21, formed of a high strength material such as polyamide, stainless steel or a convenient superelastic nickel-titanium alloy (Ni-Ti) ). The distal portion 23 of the inner tubular support member 21 can be formed of a tubular material with an inner wall as illustrated in Figure 6. The proximal waist 22 of the balloon 13 is held in a convenient manner, such as thermal bonding or by adhesive, to the outside of the distal section 18 of the arrow 11.

A proximal section 17 of the catheter shaft 11 is provided with a proximal groove 24, which extends from the proximal end of the shaft 11 to a site proximal to the guide member of the guide wire 25. This construction is typical of an exchange catheter fast on-the-convertible cable. The distal catheter shaft section 18 is also provided with a distal groove 26 extending from the second or proximal gate of guide wire 16 to a site 27 proximal to the proxirial waist 27 of the balloon 18. A guidewire 28 that is disposed slidably within the interior guidewire lumen 14, has a coil 29 at its distal end, which is illustrated in Figure 3 extending outwardly of the first guidewire gate 15, and an elongated core member 30 illustrated extends through the guide wire receiving lumen 14 and out of the second guide wire gate 16, as will be employed in a rapid exchange mode. A replacement guidewire 31 is illustrated within the guide wire lumen 14 in the proximal position of the catheter shaft 11. A multi-arm adapter 32, which is provided at the proximal end 17 of the catheter shaft 11, has a arm 33 with an inner lumen 34 which is adapted to introduce inflating fluid to the inflation lumen 12 and a second arm 35 cuts an inner lumen 36 which is adapted to receive the replacement guide wire 31 to be guided in the guide wire receiving lumen 14 within the catheter shaft 11. The proximal end of the catheter shaft 11 is provided with an insert 37 that fits inside the valve 32 as illustrated. The second arm 35 of the adapter 32 is provided with a slot 38 and the insert 37 is provided with a slot 39 both of the slots are continuous, with the slot 24 and the proximal section 17 of the arrow of the catheter 11. A portion of the insert 37 connects sealant between the inner lumen 34 with the inner inflation lumen 12 within the catheter shaft 11. The insert 37 may be formed as a separate element and then attached to the proximal end of the catheter shaft 11 or may be formed from the shaft of catheter. As illustrated in Figure 3, balloon 13 is in its deflated state to provide a low profile for crossing tight lesions. An expandable stent 40 is mounted on balloon 13, usually by compressing the stent by known means in such a manner that it is compressed tightly over the balloon. A protective liner 41 is provided to cover the stent 40 and protect the body lumen 42 from any sharp edges in the stent 40 and to assist in securing the stent 40 to the balloon 13. The protective liner 41 is particularly important when a further catheter is added. beyond a tight calcified lesion 43 as illustrated in Figure 3. Protective lugs 41 are known in the art and are described more fully in the US Patent Do not. ,458,615 commonly owned by (Klemm et al.). If a shield is used with a quick exchange catheter, the liner will require a slot for the guidewire to pass and an opening where the guidewire leaves the catheter in the gate of the guidewire 16. Following the invention as illustrated in FIG. Figures 3 to 7 illustrate a means for providing vibratory energy to the stent (and hence calcified lesion 43). A flexible wire 50 is provided for removable connection at its distal end 51 with the stent 40. The proximal end 52 of the flexible wire is connected to the source of vibratory energy 53 located external to the patient. The source of vibratory energy can be either an ultrasound device that imparts continuous energy to the flexible wire 50 or can impart pulsed energy to the flexible wire 50. The flexible wire 50 can be any metallic wire such as stainless steel or nickel titanium for example, whose materials They are capable of transmitting vibratory energy. The frequency of vibrational energy is a matter of choice and depends on numerous factors, including the hardness of the calcified lesion 43 and other conditions specific to individual patients. Also, provided that the vibrational energy source 53 alternately provides irregular, non-repetitive energy waves to the flexible wire 50, these waves are transmitted to the endoprosthesis 40 and the calcified lesion 43.

The distal end 51 of the wire 50 can be adhesively bonded to the balloon 13 and then the stent 40 can be folded over the balloon in the wire 50. After the vibrational energy is provided and the lesion is dilated, the stent remains implanted while the stent is implanted. The balloon is deflated, and together with the wire 50, the catheter is removed from the patient. In another embodiment of the invention, illustrated in Figure 8, the Vibratory energy source 53 provides vibrational energy in the form of audio sound waves. The audio sound probes are transmitted from the vibrational energy source 53 through the inflation fluid in the inflation lumen 12. The inflation fluid will transmit audio sound waves through the balloon 13 and to the stent 40, which then transmit at least partial vibrational energy to the calcified lesion 43. Following the method of use of the invention, a catheter system embodying the invention can be inserted into the patient in a conventional rapid exchange form, with the guidewire 2 pre-loaded Within the inner lumen 14 and in the distal section 18 of the catheter shaft and extending proximally away from the proximal guide wire gate 16. Alternatively, a catheter system incorporating the invention can be inserted in a conventional manner over -the wire with the guide wire extending through the entire length of the guide wire lumen 14 and out of the second arm 35 of the adapter 32. The wire g 28 and catheter 10 are advanced to the body lumen 42, for example one of the coronary arteries and the combination is advanced to a point until the calcified lesion 43. As illustrated in Figure 3, the catheter and guidewire are further advanced to be placed inside the calcified lesion 43 before inflating the balloon 13. Subsequently, the balloon 13 is inflated, which will expand the stent 40 and expand the calcified lesion 43. As the dilation procedure begins, the vibratory energy of the source of vibratory energy 53 is transmitted through the flexible wire 50, or audio sound waves are transmitted through the inflation lumen (Figure 8) to assist in the partial pulverization of the calcified lesion 43 and to make the balloon and endograft inflate an easier process. As the balloon and stent 40 expand completely, as illustrated for example in Figure 7, the calcified lesion 43 has expanded radially outward and due to the vibratory energy transmitted through the stent 40, the calcified lesion 43 is it has pulverized and disintegrated at least partially. After the body lumen 42 expands and the stent 40 expands fully and implants, the balloon 13 deflates upon removal of the inflation fluid and the catheter and guidewire are removed from the patient.

The catheter body 11 can be formed by conventional techniques, for example by extrusion of materials which are already known to be useful for producing intravacular catheters, tails such as polyethylene, polyvinyl chlorine, polyleads and composite materials. The various components of the catheter can be joined by a convenient adhesive such as the acrylonitrile-based adhesive sold under the trademark "LOCTITE 405" by Loctite Corporation. Thermal shrinkage or thermal bonding may also be employed where appropriate. The size of the catheter body 11 and the lumen guidewire interior 14 in a large proportion are determined by the size of the guidewire 28 and replacement guidewire 31 for use and the size of the artery or other body lumen through from which the catheter must pass. The catheter body 11 is long enough to extend from the proximal end of a guide catheter to a stenosis for treatment within the patient's vascular system (or other desired location in the patient's body) from about 100 to 150 cm, when a Sledinger approach through a femoral artery is used to introduce the catheter 10 to the vasculature. The wall forming the catheter should be of sufficient thickness and strength, so that it can push the guidewire 28 (or replacement guide wire 31) to the desired location within the blood vessel.

It will be understood that while PTCA has been discussed here in connection with particular embodiments of the invention, any body lumen can be treated in accordance with the method and apparatus claimed. In this manner, embodiments of the invention can be used to treat calcified or tight lesions in arteriae, veins, blood vessels, coronary arteries, carotid arteries, peripheral veins, bile ducts, the aorta and virtually any body lumen. While the invention has been described herein in terms of certain modalities currently preferred to direct satire to open calcified leeionee and to implant an endograft ah | J, those skilled in the art will recognize that the catheter of the invention can be used in a of body lumens. In addition, although a perfusion and rapid exchange type catheter was described herein, other types of catheter such as over-the-wire catheters may be employed for use with the invention to vibrate calcified leeionee. Other modifications and improvements to the invention can be made without departing from the scope thereof.

Claims (23)

1. CLAIMS 1. Apparatus for imparting vibratory energy to a stenosed region in a body lumen, characterized in that it comprises: a generally tubular and radially expandable endoprosthesis having a first collapsed condition and a second expanded condition, and adapted to be placed in contact with the region stenosated from the body lumen; a source of vibratory energy; and a flexible elongated member having a proximal end and a distal end and coupled outside the proximal end of the body to the energy source and at the end distal to the stent, whereby vibratory energy from the sources is transmitted through the endoprosthesis. of the flexible elongate member and the stent to the stenosed region.
2. 2. Apparatus according to claim 1, characterized in that the vibratory energy is generated by an ultrasound device.
3. 3. Apparatus according to claim 2, characterized in that the ultrasound device imparts continuous energy to the flexible elongate member and the endograft and therefore to the stenosed region.
4. 4. Apparatus according to claim 2, characterized in that the ultrasound device imparts pulsed energy to the flexible elongate member and the endograft and therefore to the stenosed region.
5. 5. Apparatus according to claim 2, characterized in that the ultra-sound device imparts irregular non-repetitive energy waves to the flexible elongated member and the endoprothesis and therefore to the selected region.
6. 6. Apparatus according to claim 1, characterized in that the vibratory energy is generated by a mechanical or vibratory device and wherein the flexible elongate member is a control wire coupled to the endoprosthesis.
7. 7. Apparatus according to claim 6, characterized in that the control wire is removably coupled to the endoprosthesis.
8. 8. Apparatus according to claim 1, characterized in that the vibratory energy is generated by an audio sound generating device and wherein the flexible elongated member is a lumen and inflated with an elongated catheter shaft.
9. 9. Apparatus according to claim 1, characterized in that the stent is configured to be permanently implanted in the body lumen.
10. 10. Apparatus according to claim 1, characterized in that the stent is configured to be removably implanted in the body lumen.
11. 11. Apparatus according to claim 1, characterized in that the endoprosthesis is configured to temporarily place in the body lumen.
12. 12. Apparatus according to claim 1, characterized in that the said end of the flexible elongate member is connected to the endograft.
13. 13. Apparatus according to claim 1, characterized in that the dietal end of the flexible elongate member is adjacent to the stent but not in physical contact with the stent.
14. 14. Apparatus according to claim 1, characterized in that the distal end of the flexible elongated member is in physical contact with the endoprosthesis.
15. 15. Apparatus for imparting vibratory energy to a region that is unaffected in a body lumen, characterized in that it comprises: a generally tubular and radially expandable endoprosthesis having a first collapsed condition and a second expanded condition, and adapted to be placed in contact with the stenosed region of the body lumen; a source of vibratory energy to provide vibratory energy; a catheter having a dietal end, a proximal end and an expandable region at the distal end of the catheter, and a fluid lumen extending through the catheter and in fluid communication with the expandable region, the endoprosthesis is mounted in the region expandable in the first collapsed condition; and a flexible elongate member having a proximal end and a distal end, the flexible elongate member engages outside the proximal end of the body to the vibrational energy source, and the distal end of the flexible elongate member terminates within the expandable region, whereby the inflation liquid is introduced through the fluid lumen to expand the expandable region and thereby expand the stent from the first collapsed condition to the second expanded condition and whereby the vibrational energy from the vibrational energy source transfers at least some of the vibrational energy through the inflation fluid in the expandable region to the endograft and thus to the eetenoid region.
16. 16. Apparatus according to claim 15, Characterized because vibratory energy is generated by an ultrasound device.
17. 17. Apparatus according to claim 16, characterized in that the ultra-sound device imparts continuous energy to the flexible elongate member and therefore in the stenosing region.
18. 18. Apparatus according to claim 16, characterized in that the ultrasound device imparts pulsed energy to the flexible elongated member and therefore to the stenotic region.
19. 19. Apparatus according to claim 16, characterized in that the ultrasonic device imparts an irregular non-repetitive energy wave to the flexible elongated member and, therefore, to the impaired region.
20. 20. r- Method for imparting vibratory energy to plate forming a stenosed region in a body lumen, the method is characterized in that it comprises: providing a generally tubular and radially expandable endoprosthesis having a crushed first connection and a second expanded condition; placing the stent in the squashed condition in contact with the stenosed region; supplying vibratory energy to the endograft while it is in the collapsed condition, thereby transmitting at least a portion of the vibratory energy through the stent and in the stented region; and expanding the endoprosthesis to the second expanded condition to dilate the body lumen in the area of the stenoed region.
21. 21. The method according to claim 20, characterized in that the vibrational energy is generated by an ultra-sound die.
22. 22. The method according to claim 20, characterized in that the vibratory energy is generated by a mechanical device, and in which the vibratory energy is transmitted to the endoprosthesis through a control wire connected removably to the endograft and eeta. way it will transmit to the stenotic region of the body lumen.
23. 23. A method for imparting vibratory energy to plaque forming a stenoed region in a body lumen, the method is characterized by comprising: providing a catheter having a distal end, a proximal end, an expandable region at the distal end of the catheter and a fluid lumen extending through the catheter and in fluid communication with the expandable region; providing a generally tubular and radially expandable endoprosthesis having a first collapsed condition and a second expanded condition; the stent is mounted in the expandable region in the first collapsed condition; placing the endoprosthesis and the expandable region in its collapsed condition reepectiva in the stenosed region; inserting an inflation liquid in the expandable region to partially expand the expandable region and the stent in contact with the stenoed region; e) providing ultra-sound energy to the inflation liquid in the expandable region thereby transforming vibrational energy to the stent in its partially expanded condition, and thereby additionally transmitting at least a portion of the vibrational energy to the stenoed region; expanding the endograft additionally to the second expanded condition, to dilate the detached region of the body lumen; deepen the expandable region; and removing the catheter and the expandable region of the body lumen.