US20070135714A1

Movatterモバイル変換

Info

Publication number: US20070135714A1
Application number: US11/701,654
Authority: US
Inventors: Jeffrey Steward; Mina Chow
Original assignee: Abbott Cardiovascular Systems Inc
Current assignee: Abbott Cardiovascular Systems Inc
Priority date: 2000-10-26
Filing date: 2007-02-02
Publication date: 2007-06-14
Also published as: US6554801B1; US7179249B2; US20030233065A1

Abstract

The invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient's lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

Description

FIELD OF THE INVENTION

The present invention relates to an apparatus and method for imaging the position and location of a medical device in a patient. In particular, the present invention relates to a catheter based needle drug delivery device having ultrasound imaging technology that facilitates tracking of the catheter as it is positioned within the body of a patient.

BACKGROUND

As surgical techniques continue to progress and become less invasive, an increasing number of medical procedures are performed with the aid of a catheter. In general, a catheter is a flexible tube that is inserted into narrow openings within the body and is used to deliver and/or remove fluids or substances. An example of a medical procedure that utilizes a catheter is percutaneous transluminal coronary angioplasty (PTCA).

PTCA is a catheter-based technique whereby a balloon catheter is inserted into the blocked or narrowed coronary lumen of a patient. Once the balloon is positioned at the target site, the balloon is inflated causing dilation of the lumen. The balloon is deflated and the catheter is then removed from the target site thereby allowing blood to freely flow through the unrestricted lumen.

Although PTCA procedures aid in alleviating intraluminal constrictions, such constrictions or blockages reoccur in many cases. The cause of these recurring obstructions, termed restenosis, is due to the body's immune system responding to the trauma of the surgical procedure. As a result, drug therapies are often applied in combination with the PTCA procedure to avoid or mitigate the effects of restenosis at the surgical site. The drugs are delivered to the site via a needle housed within the catheter. The term “drug(s),” as used herein, refers to all therapeutic agents, diagnostic agents/reagents and other similar chemical/biological agents, including combinations thereof, used to treat and/or diagnose restenosis, thrombosis and related conditions.

Other procedures, such as those developed to control the effects and occurrence of angiogenesis, also utilize a catheter having a drug delivery needle. Angiogenesis is a process whereby new blood vessels are grown in the body for healing wounds and for restoring blood flow to tissues after injury or trauma. Angiogenesis occurs naturally in the body, both in normal states and in disease states. For example, in females, angiogenesis occurs during the monthly reproductive cycle to rebuild the uterus lining and to mature the egg during ovulation. In addition, angiogenic growth factors are also present during pregnancy to build the placenta and create the vessels necessary for circulation between the mother and fetus.

Angiogenesis also occurs in various disease states, such as cancer, diabetic blindness, age-related macular degeneration, rheumatoid arthritis, coronary artery disease, stroke, and other disorders. In cases of excessive angiogenesis, the new blood vessels feed diseased tissues, destroy normal tissues and, with respect to cancer, allow tumor cells to escape into the circulation and lodge in other organs. Conversely, insufficient angiogenesis causes inadequate blood vessel growth thereby impeding circulation which, in turn, potentially leads to tissue death.

Although angiogenesis occurs naturally in the body, various procedures have been developed to artificially control the occurrence and effects of angiogenesis. One such procedure is Percutaneous TransMyocardial Revascularization (PTMR). PTMR utilizes a laser catheter to create small channels in the diseased tissue. The channels re-establish direct blood flow to the tissue and allow oxygen-rich blood to saturate the oxygen-starved tissue. PTMR is generally used for the treatment of severe, end-stage coronary disease.

Another catheter-based procedure used to promote angiogenesis involves gene therapy. For this procedure, genetic material is delivered directly to the diseased area of the body via a catheter. In particular, genetic material, such as Vascular Endothelial Growth Factor (VEGF), is incorporated into gene delivery vehicles called vectors, which encapsulate therapeutic genes for delivery to the diseased cells. Many of the vectors currently in use are based on attenuated or modified versions of viruses. The vectors may also be synthetic versions in which complexes of DNA, proteins, or lipids are formed into particles capable of efficiently transferring genetic material. A needle injection catheter is used to deliver the vectors containing the genetic material to the appropriate cells of the patient in a safe and efficient manner.

These and other similar catheter-based procedures require accurate tracking of needle location as the catheter and needle are maneuvered through the system to the target site in the patient. Conventional catheter-based needle drug delivery devices utilize fluoroscopic imaging methods to track catheter and needle movement in the body of a patient. In general, a radiopaque coating is applied in a thin, dense layer on a portion of the catheter and/or needle that is then viewed utilizing a fluoroscope. However, this method is limited to visualizing device placement within the artery. This is a limitation when the target for the needle-born drug/therapy is outside the delivery vessel. Further, this method produces a planar (two-dimensional image) which may not be sufficient to accurately steer or track the location of the catheter through the body of the patient. In addition, due to inadequate fluoroscopic imaging resolution and limited mass/density of radiopaque material, these devices are also limited in their effectiveness to accurately position the catheter needle at the desired target site.

SUMMARY

In view of the above, there is a need to provide a catheter-based needle drug delivery device having retractable ultrasonic imaging features that increases imaging resolution and improves catheter tracking capabilities. It is also desirable that the catheter-based needle drug delivery device be used in combination with intravascular ultrasound (IVUS) technology for mapping needle position in the body of the patient. In particular, it is preferred that the ultrasound imaging features of the present device enable a user of the device to precisely determine needle position in relation to both the host catheter as well as the vessel wall and target site for drug delivery.

In accordance with various aspects of the present invention, the invention relates to an apparatus and method for imaging and mapping various structures located at a target area within a patient's lumen using conventional IVUS technology. The mapped images are used to accurately determine and control the location of the device within the lumen relative to the target area and/or target site. Once the drug delivery device is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of a retractable needle of the device. Needle position can be precisely determined, both in relationship to the device as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the described embodiments are specifically set forth in the appended claims. However, embodiments relating to both structure and method of operation are best understood by referring to the following description and accompanying drawings, in which similar parts are identified by like reference numerals.

FIG. 1 is a perspective view of a catheter based needle drug delivery device and ultrasound imaging system;

FIGS. 2a-2eare cross-sectional views of various embodiments of a catheter based needle drug delivery device;

FIG. 2fis a detailed cross-sectional view of the distal portion of the device ofFIGS. 2a-2e;

FIG. 3 is a detailed cross-sectional view of the ultrasound transducer ofFIG. 2f;

FIG. 4 illustrates one embodiment of the catheter based needle drug delivery device positioned within a lumen;

FIG. 5 illustrates the ultrasound field wave generated by the device ofFIG. 4;

FIG. 6 illustrates one embodiment of the display, imaging and stacking functions of an IVUS system;

FIG. 7 is a cross-sectional view of a lumen;

FIG. 8 illustrates a method of using the device ofFIG. 4;

FIG. 9 illustrates one embodiment of the image of the lumen and device ofFIG. 4;

FIG. 10 illustrates an alternate embodiment of the image of the lumen and device ofFIG. 4; and

FIG. 11 illustrates another embodiment of the image of the lumen and device ofFIG. 4.

DETAILED DESCRIPTION

An exemplary catheter-based needledrug delivery device10 and ultrasonicimaging display system12 are shown schematically inFIG. 1. Theimaging display system12 includes an image processor having adisplay14 and asignal processor16. Both theimage processor14 andsignal processor16 are general purpose processors of the type that are commonly used in connection with devices similar to that of the present invention. Additional disclosure of theultrasonic imaging system12 is discussed in further detail below.

FIGS. 2aand2bshow cross-sectional views of the catheter-based needledrug delivery device10. In general, thedevice10 includes anelongate body18 that surrounds aneedle lumen82 and aninner lumen22. Housed within theinner lumen22 are afluid lumen24 and aninner member26 that also contains aguide wire lumen44 andultrasonic element lumen50. Aninflatable balloon28 is attached to theinner lumen22 and theinner member26. In general, theproximal end30 of theballoon28 is attached to adistal end32 of theinner lumen22 and thedistal end34 of theballoon28 is attached to thedistal end36 of theinner member26. In the spirit of convenience and brevity, the device referenced in the text and figures of the present disclosure is configured according to the above-described design. However, it should be noted that other designs of the catheter-based needle drug delivery device are also within the scope of the claimed invention.

For example, in another embodiment of the device shown inFIG. 2c,both theguide wire46 and retractableultrasonic element52 are housed within a single lumen, i.e. theinner member26. Theelongate body18 surrounds aninner lumen22 and aneedle lumen82. Housed within theinner lumen22 are aninner member26 and afluid lumen24. Theinner member26 surrounds theguide wire46 and retractableultrasonic element52. Aninflatable balloon28 is attached to theinner lumen22 and theinner member26. In general, the proximal end of theballoon28 is attached to the distal end of theinner lumen22 and the distal end of theballoon28 is attached to the distal end of theinner member26.

In yet other embodiments of the device, shown inFIGS. 2dand2e,theinner lumen22 also serves as the lumen through which fluid flows to inflate and/or deflate theballoon28. As such, the separate fluid lumen, described above, is omitted from the catheter-based needledrug delivery device10. Thus, theinner lumen22 functions as a fluid lumen in addition to housing theguide wire lumen44 andultrasonic element lumen50. Alternatively, theinner lumen22 functions as a fluid lumen and also contains theguide wire46 and retractableultrasonic element52.

The structure of theinflatable balloon28 is similar to those well known to those having ordinary skill in the art. Theinflatable balloon28 may be used for various procedures including, but not limited to, opening narrowed passageways, distributing drugs to specific target sites, and delivering/positioning stents or other medical devices within the lumen. The term “target site,” as used herein, refers to sites/areas both inside and outside the vessel/lumen. Theinflatable balloon28 is located at thedistal end38 of thedevice10 and is initially deployed in a low profile, deflated condition. When theballoon28 is positioned at the target site it is inflated with fluid via theinflation port40 located near theproximal end42 of thedevice10. During inflation of theballoon28, fluid flows from theinflation port40, through thefluid lumen24, and to theballoon28. In addition, the fluid flows through thesame lumen24, but in the opposite direction, upon deflation and subsequent removal of theballoon28.

Extending partially along the length of thedevice10 is theinner member26. As shown inFIGS. 2a-2e,a portion of theinner member26 protrudes out thedistal end34 of theballoon28. Housed within and along the length of theinner member26 are two lumens. Thefirst lumen44, i.e. the guide wire lumen, provides a passageway for amovable guide wire46. Theguide wire46 extends from beyond thedistal end38 of thedevice10 to aguide wire exit48 located near theproximal end42 of thedevice10. Theguide wire46 serves as the steering mechanism of thedevice10 and enables an operator to maneuver thedevice10 through the various vessels and lumens of the patient to the chosen target site. Overall length and diameter of theguide wire46 are within the range of approximately 74.8 inch to 118.1 inch (190 cm to 300 cm) and 0.0152 inch to 0.019 inch (0.0386 cm to 0.0483 cm), respectively. Theguide wire46 may be fabricated from a variety of materials including, but not limited to, stainless steel, Nitinol™, platinum and polymers. These and other similar materials exhibit the required structural properties, such as strength and flexibility, desired inguide wire elements46.

Thesecond lumen50, i.e. the ultrasonic element lumen, of theinner member26 houses the retractableultrasonic element52 of thedevice10. As shown inFIGS. 2band3, the distal end of theultrasonic element52 has an ultrasound transducer ortransducer array54 and the proximal end contains the associatedco-axial cable56 that connects to the imaging display system12 (i.e. IVUS imaging system). In general, ultrasonic waves generated by theultrasonic element52 impinge on the surface of the target area. The timing/intensity of the ultrasonic waves reflected back to thetransducer54 differentiates between the various anatomic boundaries or structures of the target area. The waves detected by thetransducer54 are converted to electric signals that travel along thecoaxial cable56 to theimaging system12. The electrical signals are processed and eventually arranged as vectors comprising digitized data. Each vector represents the ultrasonic response of a different angular sector of the target area and/or bodily lumen. As such, the amplitude of the reflected ultrasonic waves/electric signals is displayed as variable shades of, for example, gray on the display. Thus, anatomic structures with different acoustic density are portrayed with varying degrees of brightness, resulting in a visible, displayed image of the various structures within the body.

Thecoaxial cable56 of theultrasonic element52 contains an insulated solid or stranded center conductor58 (e.g., a wire) surrounded by a solid or braidedmetallic shield60, wrapped in a plastic cover orjacket62. Thewire58 is the primary conductor, whereas theshield60 is used for ground. Theinsulation64 surrounding thewire58 is typically made of a dielectric material, such as polyester or plastisol, and functions to sustain the current traveling within thewire58 with minimal dispersion. Aconductive material66, for example copper, gold, palladium, conductive epoxy, or other similar materials, is used to attach and electrically connect the distal end of thecoaxial cable56 to theultrasound transducer54.

Theultrasound transducer54 has apiezoelectric crystal68 configured for optimal acoustic output efficiency and energy conversion. In some embodiments, thecrystal68 is made of PZT or lead-ceramic materials, such as PbTiO₃(lead titanate) or PbZrO₃(lead zirconate). As shown inFIG. 3, theback surface70 of thepiezoelectric crystal68 is coated with conductive material plating such as gold, platinum or palladium, and other similar conductive materials. The gold plating provides a sufficient electrical contact to theback70 of thepiezoelectric crystal68 to connect with thewire58 of thecoaxial cable56. Aconductive epoxy72 is used to mechanically and electrically attach or connect thecoaxial center conductor58 to theback70 of thepiezoelectric crystal68. In addition toconductive epoxy72, solder joints, cold solders, ultrasonic welds and other similar attachment techniques can also be used.

Thefront surface74 of thepiezoelectric crystal68 is also coated with conductive material plating. The front surface plating electrically connects thefront surface74 of thecrystal68 to thecoaxial shield60 through theconductive material66. Partially surrounding thecrystal68 and its related components is abacking material76. Thebacking material76 serves as a non-conductive sound absorbing material that eliminates sound waves coming off theback70 of thepiezoelectric crystal68. In addition, thebacking material76 also facilitates rapid reduction in piezoelectric oscillations.

To electrically isolate theultrasound transducer54, thetransducer54 is covered in aparalyene coating78. Theparalyene coating78 is a quarter wave matching layer that does not interfere with the acoustic output or response of the piezoelectric element. In addition, the paralyene electrically isolates the two sides of the piezoelectric crystal and associated electrical connections.

As shown inFIGS. 2aand2b,the device also includes aretractable needle80 housed in theneedle lumen82 and freely movable therein. The hollow, tubular shapedneedle80, having an inner diameter within the range of approximately 0.002 inch to 0.010 inch (5.1×10⁻³cm to 25.4×10⁻³cm) and an outer diameter within the range of approximately 0.004 inch to 0.012 inch (10.2×10⁻³cm to 30.5×10⁻³cm) provides a fluid conduit that extends from theproximal end84 to thedistal end86 of theneedle80. Thedistal end86 of theneedle80 terminates in a curved, tissue piercing tip having an angle of curvature between 30 degrees to 90 degrees. Needle curvature facilitates placement of the needle tip near to or within the desired target tissue. Further, to allow easy needle deployment from and retractability into the lumen, yet provide sufficient structural strength for insertion into tissue, theneedle80 is preferably fabricated from, for example, stainless steel, NiTi (nickel titanium), platinum or other similar semi-rigid materials. The needle can also be coated with fluoroscopically opaque materials to enhance its imaging capabilities on the fluoroscope.

Near theproximal end84 of theneedle80, theneedle80 connects to anadapter86 that attaches theneedle80 to aneedle lock88 and a needleadjustment puncture knob90. Theneedle lock88 is used to secure theneedle80 in place and prevent further movement of theneedle80 within the lumen once theneedle80 is located in the desired position. Aneedle adjustment knob90 controls accurate needle extension out of the distal end of the catheter and depth of penetration into the tissue target. In general, theneedle adjustment knob90 is slidable along a proximal portion of the needle lumen or element89 housing theneedle80. The element89 includes various gradations or scalable markings along a portion of its length that correspond to the length ofneedle80 extending out from theneedle lumen82. During use, theneedle adjustment knob90, that is also attached to the proximal end of theneedle80, is locked into position at a marking corresponding to the desired length of needle extension from the catheter. Theknob90 is then moved in a distal direction until it butts against theneedle lock88. Movement of theknob90 also moves theneedle80, so that the predetermined length ofneedle80 extends out from theneedle lumen82. Theneedle lock88 is then used to secure theneedle80 in place and prevent further movement of theneedle80 within the lumen.

Located near theproximal end42 of thedevice10 is adrug injection port92. Theport92 provides a connection for various dispensing elements such as a syringe, fluid pump, etc. In addition to drugs, other fluids including, but not limited to, therapeutic agents and diagnostic substances, may also be injected into theport92 for delivery to the target site. Fluids injected into theport92 travel through theneedle80 and are dispensed from the distal tip of theneedle80.

In an alternate embodiment, theneedle80 can also be used to aspirate fluid from tissues. A negative pressure or suction is applied at thedrug injection port92. The resulting pressure differential within thelumen82 of theneedle80 causes tissue fluid to be drawn into the tip of theneedle80. The fluid travels toward theproximal end84 of theneedle80 and is collected at theinjection port92 site for further analysis.

Method of Use

The retractableultrasonic element52 of thedrug delivery device10 allows the various structures located at a target area within a patient's lumen to be imaged and mapped using conventional IVUS technology. The mapped images are used to accurately determine and control the location of thedevice10 within the lumen relative to the target area and/or target site. Generally, the target area and/or target site is the narrowed or diseased portion of the lumen requiring drug therapy. Once thedrug delivery device10 is properly positioned within the lumen, additional ultrasonic images are generated and used to control the position and depth of penetration of theretractable needle80. As such, needle position can be precisely determined, both in relationship to thedevice10 as well as the target site for drug delivery. This allows accurate delivery of drug to the target site and, thus, enhanced treatment capabilities.

During use of thedevice10, thedistal end38 of the device orcatheter10 is inserted into the lumen of the patient and guided to the target area, i.e. narrowed area due to plaque buildup, via conventional methods. As shown inFIG. 4, thedistal end38 of thecatheter10, in particular the retractable ultrasonic element (not shown), is positioned near thetarget site94 of the patient'slumen96. In one embodiment, the retractable ultrasonic element is positioned distal to thetarget site94 of the patient's lumen. Thetarget area95 is then imaged using IVUS technology. In general, a signal, in the form of a voltage pulse, generated by the signal processor of the IVUS system (not shown) travels through the coaxial cable to the ultrasound transducer of the ultrasonic element. The voltage pulse results in an electromotive force that causes the crystal of the transducer to oscillate, thereby producing sonic waves.

As shown inFIG. 5, theultrasonic waves98, forming an energy waveform field, emanate from the ultrasound transducer (not shown) into the surrounding tissues and structures. Waves reflected by tissues, or other structures in thelumen96 near thetarget area95, and detected by the ultrasound transducer are converted back to electric signals. The signals travel along the coaxial cable to the imaging system where they are then processed. As a result, a first axial, cross-sectional image of the various structures is generated and displayed on the IVUS system. The image that appears on the display is then adjusted and optimized, in terms of gain, zoom, and other related resolution variables.

To obtain a mapped, longitudinal view of thelumen96, the distal end of theultrasonic element52 is slowly moved in the proximal direction. Movement of theultrasonic element52 may be either manually and/or automatically controlled. Approximately hundreds of cross-sectional images are generated, similar to the above-described single-image procedure, and then stacked in real time.FIG. 6 representatively illustrates the imaging and stacking functions performed by an IVUS system. A single,cross-sectional image100 of alumen96 is displayed on themonitor14. Additionalcross-sectional images102, generated as the ultrasonic element52 (not shown) is slowly moved through the lumen, are shown in hatched lines. Theseimages102 are collected and processed, or stacked, by the system in real-time mode. The developinglongitudinal view104 of the lumen96 (also shown in hatched lines) as theultrasonic element52 is moved through thelumen96 can also be displayed on themonitor14 of the IVUS system. Therefore, the IVUS system can either display a two-dimensional cross-sectional image of thelumen96 or a three-dimensional longitudinal view of thelumen96.

In general, a vascular or arterial image consists of three layers that make up the walls of thelumen96. As shown inFIG. 7, theinner-most radial layer106, which, for example, surrounds thehollow channel108 of thelumen96 through which blood flows, contains endothelial cells. White blood cells migrate from the bloodstream into the endothelial cells of thelumen96 and are transformed into cells that accumulate fatty materials. The accumulatedmaterials110, also termed plaque, continue to build within the lumen. As theplaque110 thickens, thechannel108 within thelumen96 narrows. Theplaque110 may further occlude thelumen96 until it is completely closed or it may detach and float downstream, causing an obstruction elsewhere.

Surrounding the endothelial cells is a layer ofsmooth muscle cells112. In addition to reducing thelumen opening108, theplaque110 may also stimulatesmooth muscle growth112. Proliferation ofsmooth muscle cells112 further contributes to decreasing the size of thelumen opening108. Theoutermost layer114 of thelumen96 is termed the adventitia. In general, the function of the adventitia is to provide nutrients to the vessel wall.

In an alternate embodiment, theinternal lumen96 may also be imaged by initially positioning the tip of theultrasonic element52 proximal to thetarget area95. As such, a longitudinal view of thelumen96 may be obtained by slowly pushing theultrasonic element52 in the distal direction until the tip of theultrasonic element52 is located distal to thetarget area95. In another embodiment, theultrasonic element52 is pushed and/or pulled repeatedly across thetarget area95 to obtain numerous detailed images and views of thelumen96 and structures within thelumen96. Other areas or structures of interest within thelumen96 may also be investigated using the methods described above.

In addition to displaying the internal surface of thelumen96, thedevice10 is also used to accurately determine catheter position with respect to thetarget site94 within the lumen. In addition to specifically targeting the desired regions of thelumen96, thetransducer54 is also used to accurately track the position and location of theretractable needle80. Therefore, both the exact location and depth of needle penetration are determined with thedevice10.

By imaging thetarget area95 of thelumen96, a user of the device is able to precisely identify the desired injection site. As previously explained, angiogenesis, restenotic drug therapies and other related procedures require injections of various fluids including, but not limited to, therapeutic agents, diagnostic reagents, and genetic material, whereby the fluids are delivered directly to the diseased area of thelumen96. Ultrasonic imaging enables device users to track needle movement and penetration into tissue.

The imaging technique requires an initial imaging of thetarget area95. As shown inFIG. 8, the retractable ultrasound element (not shown) of thedevice10 maps the inner surface of thetarget area95 adjacent to the balloon (not shown) with the aid of aconventional IVUS system12. In addition, the position of the retractable needle (not shown) is also mapped using the same ultrasound element andIVUS system12.FIG. 9 illustrates one image of thecatheter10 andretractable needle80 within thelumen96 as mapped using the ultrasound technique. The differential density between the needle material and the target tissue results in a discrete and easily identifiable IVUS signal. As such, needle position can be precisely determined, both in relationship to thehost catheter10 as well as thetarget site94 for drug delivery.

Since the size of thecatheter10 and its components are known, accurate calculations and measurements can be made of the structures within thelumen96. When theneedle80 is optimally positioned at thetarget site94, theballoon28 is inflated with fluid. As shown inFIG. 10, theinflated balloon28 securely situates thecatheter10, and thereby theneedle80, within thelumen96. Theinflated balloon28 also prevents thecatheter10 from sliding out of position when theneedle80 is inserted into the tissue. In general, as theneedle80 is advanced out of theneedle lumen82 and contacts the tissue surface, the resistance of the tissue to needle penetration has a tendency to force the associatedcatheter10 in a direction approximately opposite to the direction of needle advancement/penetration. However, the friction between theinflated balloon28 contacting the tissue surfaces prevents movement of thecatheter10 in the opposite direction. Due to the added support from theballoon28, theneedle80 is allowed to advance and thereby penetrate the tissue. As shown inFIG. 11, the depth of needle penetration can be easily calculated using the ultrasonic image. As such, theneedle80 can be extended a predetermined depth into the tissue and/ortarget site94. This allows accurate delivery of, for example, drug to thetarget area95 and, thus, enhanced treatment capabilities.

After the desired amount of drug is delivered to thetarget site94, theneedle80 is retracted and removed from the tissue. The fluid is also removed from theballoon28 so that theballoon28 returns to a low profile, deflated state. At this point, thedevice10 may be repositioned at analternate target site94 for additional drug delivery according to the above-described procedure. Alternatively, upon completion of the procedure, thedevice10 may simply be removed from thelumen96 of the patient.

Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims

1.-18. (canceled)

19. A device for delivering a drug directly to a target site comprising:

an elongate body having a first lumen and a needle lumen;

a retractable ultrasonic element positionable in said first lumen;

a retractable needle positionable in said needle lumen; and

an intravascular ultrasound (IVUS) system connected to a proximal end of said retractable ultrasonic element.

20. A device for delivering a drug directly to a target site comprising:

an elongate body having a first lumen and a needle lumen;

a retractable ultrasonic element positionable in said first lumen and adapted to generate a real-time image of the target site; and

a retractable needle housed within said needle lumen.

21. A device for delivering a drug directly to a target site comprising:

an elongate body having a first lumen and a needle lumen;

a retractable ultrasonic element positionable in said first lumen;

a retractable needle positionable in said needle lumen; and

an intravascular ultrasound (IVUS) system connected to a proximal end of said retractable ultrasonic element adapted to process images generated by the ultrasonic element when positioned distal the target site and when moved in a proximal direction.

22. A device as inclaim 20 further comprising:

an inflatable balloon coupled near a distal portion of the elongate body.