Abstract:
A therapeutic delivery device is provided wherein a delivery body is supported by an elongate member such that the body may rotate as it delivers therapeutic to a target site. Therapeutic may be delivered by deploying delivery heads into a target site as well as by dispensing therapeutic from the delivery head. The delivery body may be cylindrically shaped, spherically shaped or shaped in various other configurations. In one embodiment the delivery body contains tracks that may roll back and forth over a target site to dispense therapeutic. In another embodiment, the delivery heads of the delivery body have internal valves that open and close in order to dispense therapeutic.

Description:
FIELD OF THE INVENTION 
     The present invention relates to the delivery of therapeutic to a target area. More particularly, the present invention relates to therapeutic delivery devices, methods or systems with one or more therapeutic delivery bodies that have new and unique degrees of freedom of motion. 
     BACKGROUND 
     The delivery of therapeutic to a target site is an important and often repeated practice of contemporary medicine. Target sites, where the therapeutic may need to be deposited, can be located in areas that are easily accessible as well as in areas that are more difficult to reach. When the areas are easily accessible a hand-held syringe or other hand-held device may be used to deliver the therapeutic. When the areas are not easily accessible, a remote delivery device or system may be used. These may include an endoscope working in conjunction with a catheter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing and further features and advantages of the invention will become apparent from the following description and the accompanying drawings, where like numerals are used to represent like elements and, wherein: 
         FIG. 1  is a plan view of the proximal end of a catheter that may be employed in an embodiment of the present invention; 
         FIG. 2  is a catheter positioned within the vascular system of a patient in accord with an embodiment of the present invention; 
         FIG. 3  is a side view of a portion of a distal end of a rotatable multi-head delivery device in accord with the an embodiment of the present invention; 
         FIG. 4  is a top view of the multi-head delivery device of  FIG. 3 ; 
         FIG. 5  is a partial cross-sectional side view of a head in a closed position, as may be employed in the present invention; 
         FIG. 6  is a partial cross-sectional side view of the head from  FIG. 5  showing the head in an open position, as may be employed in the present invention; 
         FIG. 7  is a side view of a portion of a distal end of a multi-head delivery device in accord with the present invention; 
         FIG. 8  is a top view of the device of  FIG. 7 ; 
         FIG. 9  is a partial cross-sectional side view of a collapsed multi-head delivery device in accord with an embodiment of the present invention; 
         FIG. 10  is a partial cross-sectional side view of the multi-head delivery device of  FIG. 9  in an expanded position, also in accord with the present invention; 
         FIG. 11  is a partial cross-sectional side view of the multi-head delivery device of  FIG. 9  with the multi-head body retracted back into the distal end of the catheter, also in accord with the present invention; 
         FIG. 12  is a perspective view of a distal end of another multi-head delivery device, also in accord with the present invention; 
         FIG. 13  is a perspective view of another multi-head delivery device, also in accord with the present invention; 
         FIG. 14  is a partial cross-sectional view of another multi-head delivery device, also in accord with the present invention; 
         FIG. 15  is a partial cross-sectional view of the rotatable body of the multi-head delivery device of  FIG. 14 ; 
         FIG. 16  is a partial cross-sectional view of the rotatable body of  FIG. 15  with a head in a fully extended position; 
         FIG. 17  is the partial cross-sectional view of the rotatable body of  FIG. 15  with the head in a retracted position; 
         FIG. 18  is a partial side view of a portion of a distal end of another multi-head delivery device, also in accord with the present invention; 
         FIG. 19  is a partial side view of the multi-head delivery device of  FIG. 18  in an expanded position; 
         FIG. 20  is a flow diagram of a method of using a multi-head delivery device in accord with the present invention; and 
         FIG. 21  is a head design in accord with the present invention. 
         FIG. 22  is a multi-head delivery device that employs an inner rotatable disc valve in accord with an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the present invention are directed to devices, methods and systems for therapeutic delivery that employ multiple therapeutic delivery heads. In some embodiments, a device, system or method may be used for delivering therapeutic and other agents or fluids to a target site of a patient&#39;s body. The device, system or method may include a rotating multi-headed delivery body where one or more therapeutic delivery heads may be able to dispense therapeutic therefrom. The dispensing end of each head may be in fluid communication with a therapeutic supply, which may be within the head and elsewhere. The) device may be used to deliver therapeutic to a target site during or subsequent to the spinning or rotation of the delivery body. These heads may pierce into the target site, may simply deposit the therapeutic and may have other defining features. These as well as other aspects of the invention are provided herein. 
       FIG. 1  is a plan view of the proximal end of a catheter  100  that may be employed in accord with the present invention. This catheter  100  may include a housing gauge  150 , a first lumen  112 , a second lumen  122  with a luer fitting  130 , indices  152 , and pointer  140 . The pointer  140  may indicate to a practitioner the distance that the second lumen  122  has slid within the first lumen. This may indicate how far the second lumen is extending from the first lumen if the second lumen is long enough to extend from the end of the first lumen. The various embodiments of the present invention may use this catheter  100  as a supply line to the rotatable delivery bodies described herein. Other sources of therapeutic may be used as well. 
     The shaft  110  of the catheter  100  may have a reinforcement member therein. This member may include a co-braided polymer tube, a co-extruded tube with two or more polymers, one or more rigid polymer or metallic wires and rods embedded in a polymer tube. It may also include two coaxial tubes, one being of a rigid nature, mechanically joined by, for example, a heat shrink tube over a polymer tube. The first lumen  112  and the second lumen  122  may be made of various metallic and non-metallic materials. These materials may include, but are not limited to, stainless steel and nickel-titanium alloy. Regardless of which materials are used for first the first lumen  112  and the second lumen  122 , it is preferred that the materials be chosen such that they have compatible physical properties in order to be able move in a one to one relationship as the catheter  100  is snaked through a patient. This one to one relationship increases the likelihood that the movement of the second lumen within the first lumen can be accurately measured by gauge  150 . 
       FIG. 2  shows a catheter  100  within the vascular system  220  of patient  200 . Also shown in  FIG. 2  are the heart  210 , blood vessels  230  and  232 , access sheath  240 , and leg  250  of patient  200 . 
     As is shown, a distal end of catheter  100  may be disposed within heart  210 . Specifically, a distal end of catheter  100  may be disposed against tissue of a wall of heart  210 . Once positioned there, the multi-head delivery body of the present invention may be used to deliver therapeutic to the heart or other target site. 
       FIG. 3  is a side view of a multi-head delivery device  300  in accord with an embodiment of the present invention. This device  300  as well as other devices of the present invention may be used with the catheter system  100  described above as well as with other positioning and control systems. It is preferred that these systems be steerable or otherwise controllable such that a practitioner may direct their location and position during a medical procedure. The device  300  in  FIG. 3 , has a first elongate shaft  310 , a distal end  311 , and a lumen  312 . Distal end  311  may be rotably coupled to an axle  316 , the axle defining a lumen  317  and co-axially aligned with the multi-head delivery body  320 . Axle  316  may also be in fluid communication with lumen  312  and inner cavity  321  of the multi-head delivery body  320 . Multi-head-delivery body  320  may include a first circular side  322 , a second circular side (not shown), and a circular wall portion  323  extending between outer diameter edges of first circular side  322  and second circular side, the circular sides defining inner cavity  321 . Multi-head delivery body  320  may also include multiple injection heads  324 , which may be evenly spaced around an exterior surface of circular wall portion  323 . 
     Embodiments of the present invention are contemplated in which multi-head delivery body  320  may have a total diameter including multiple injection heads  324  that fit within a 9 french or larger catheter. Multiple embodiments of the present invention are contemplated including the single row of injection heads  324  around circular wall portion  323  as shown in  FIG. 3 , multiple rows of injection heads  324  with aligned columns, and multiple rows of injection heads  324  with heads in every other row being aligned with each other. Other orientations are also plausible. Each injection head  324  may include an upwardly and inwardly extending conical wall portion  325 , which may define a base opening  326  in wall portion  323  and a port  327  with a lumen  328  extending there between. Lumen  328  may have a conical shape similar to conical wall portion  325  defined by an inner surface of conical wall portion  325 , with an embodiment of the present invention. 
     Alternative embodiments of lumen  328  are also contemplated to include, for example, a cylindrical lumen, as well as various other shaped lumens. Moreover, first elongate shaft  310  may be straight and run along one side of multi-head delivery body  320 , first elongate shaft  310  may also be angled near distal end  311 . 
     In accord with embodiments of the present invention, each injection head  324  may include a substantially circular hinged base opening cover  330  coupled to a plunger  332 . The proximal end  333  of the plunger may be coupled to substantially circular hinged base opening cover  330  and a distal end  334 , extending out through port  327 . Cover  330  may be biased against an inner surface of circular wall portion  323  to close off opening  326  by, for example, a spring loaded hinge. Although, for reasons of clarity and ease of illustration, only one injection head  324  is illustrated with cover  330  and plunger  332 , each injection head  324  may also be so configured. Moreover, proximal end  333  may also be coupled to cover  330  at a substantially 90° angle while distal end  334  may include a rounded tip  335  that may extend out past port  327 . Also, regardless of the shape of lumen  328 , hinged based cover  330  may be sized to provide a liquid-tight seal, thereby preferably ensuring no fluid from inner cavity  321  may escape when hinged base opening cover  330  is covering opening  326 . 
     In  FIG. 3 , rounded tip  335  may have a diameter smaller than a diameter of port  327 . This allows rounded tip  335  to retract through port  327 . This allows rounded tip  335  to retract through port  327  and back into lumen  328  to open opening  326  when urged in the proximal direction. This may occur when rounded tip  335  is pressed against a target site. Rounded tip  335  may extend out past port  327  when not pressed against the target tissue site. Cover  330  may be biased toward the inner surface of circular wall portion  323 . In general, rounded tip  335  will be sized to permit fluid within inner cavity  321  to escape through lumen  328  in injection tip  324  when rounded tip  335  is pushed back within lumen  328 . Similarly, when rounded tip  335  is extended past port  327 , hinged base opening cover  330  may seal substantially circular base opening  326  to prevent fluid within inner cavity  321  from escaping through lumen  328 . In some embodiments the therapeutic may be under pressure from the delivery head and/or a lumen in communication with the delivery head. 
       FIG. 4  is a top view of a portion of the multi-head delivery device of  FIG. 3 , in accord with an alternate embodiment of the present invention. In  FIG. 4 , a first elongate shaft  410  may have a proximal end (not shown) and a distal end  411  with a lumen  412  extending there between. Distal end  411  may be rotably coupled to axle  316  defining lumen  317 , which may be coupled to and co-axially aligned with multi-head delivery body  320 . Axle  316  may be in fluid communication with lumen  412  and inner cavity  321  within multi-head delivery body  320 . In the embodiment in  FIG. 4 , first elongate shaft  412  may be radially aligned with multi-head delivery body  320  and may have an end section  413  including a substantially perpendicular section  415  proximal of multi-head delivery body  320 . As shown in the embodiment in  FIG. 4 , multi-head delivery body  320  may have a single row of injection heads  324 . There may be other configurations and alignments as described herein as well. 
     First elongate shaft  410  may have a symmetrical end section  413 ′ (shown in phantom line). This may include a substantially perpendicular section  415 ′, that may extend past second circular surface  422  of multi-head delivery body  320  and be coupled to a final distal section  417 ′ of first elongate shaft  410 . This distal section  417 ′ may also substantially perpendicular to substantially perpendicular section  415 ′ and substantially parallel to first circular surface  322  of multi-head delivery body  320 . Distal end  411 ′ may be rotably coupled to and co-axially aligned with another axle  416 , which may be co-axially aligned with axle  316 . Symmetrical end section  413 ′ may also be in fluid communication with inner cavity  321 . First elongate shaft may take other configurations as well. 
       FIG. 5  is an enlarged partial cross-sectional view of an injection head in accord with an embodiment of the present invention. In  FIG. 5 , base cover  330  covers base opening  326  of injection head  324 . Hinged base cover  330  may include a hinge  510  that may be coupled to a substantially circular plate  520  and an inner surface of circular wall portion  323  adjacent to substantially circular base opening  326 . Hinge  510  may bias substantially circular plate  520  against the inner surface of circular wall portion  323  by, for example, a spring  511 . In general, spring  511  may be arranged in a similar fashion to a spring in a standard mousetrap that urges the arm of the mousetrap against the base. The force of spring  511  may be sufficient to prevent substantially circular plate  520  from unsealing from the inner surface of circular wall portion  323  when multi-head delivery body  320  is rotated. In addition, substantially circular plate  520  may include a material that may form a tight liquid seal when biased against the inner surface of circular wall portion  323 . For example, substantially circular plate  520  may be comprised of the material and/or include the material only on the side facing the inner surface of circular wall portion  323 , where the material may include natural rubber, isoprene, urethane, latex, acrylonitrile/butadiene, cyanoacrylate, fibrin, collagen and/or silicone. 
       FIG. 6  is an enlarged partial cross-sectional side view of a portion of a head in an open position, in accord with an embodiment of the present invention. In  FIG. 6 , substantially circular plate  520  may be displaced from the inner surface of circular wall portion  323  as the plunger  332  is urged in the proximal direction. This will force rounded end  335  into port  327 . Displacing substantially circular plate  520  away from the inner surface of circular wall portion  323  may create a vent  610  for the fluid in inner cavity  321  to enter lumen  328  through substantially circular base opening  326  and exit through port  327 . In the open position, spring  511  may be compressed so that it may exert a bias against substantially circular plate  520  to return to the closed position shown and described in  FIG. 5 . 
       FIG. 21  is an enlarged view of another head  2102  that may be employed by one or more of the rotatable bodies of the present invention. Like the other heads, they may be spaced and positioned in various locations and may be employed with other types of heads on the same system or device. A plunger  2103 , flap  2104 , biasing element  2105 , and multi-head rotatable body  2101 , may all be seen in this figure. The biasing element  2105  may act to keep the plunger  2103  in a closed position until the plunger is depressed. 
       FIG. 7  is a side view of a portion of a distal end of another multi-head delivery device in accord with the present invention. In  FIG. 7 , a multi-head delivery device  700  may include an elongated shaft  710  having a proximal end (not shown), a distal end  711 , and a lumen  712  there between. Multi-head delivery device  700  may be disposed in a catheter  705  having a proximal end, a distal end, and a lumen extending there between. Elongated shaft  710  may be rigidly coupled to and coaxially aligned with an axle  716  having a lumen  717  that may be coupled to a multi-head delivery body  720  to permit lumen  712  to be in fluid communication with an inner cavity  721  through an opening in a first side surface  722  in multi-head body  720 . Multi-head body  720  may include an outer tread  723  having multiple injection heads  724  and an inner portion  729  defining inner cavity  721 . Outer tread  723  may be adapted to rotate around inner portion  729  and to receive and hold fluid to be ejected from each injection head  724  either from within outer tread  723  or inner cavity  721 . For example, outer tread  723 , as in other embodiments, may be adapted to receive and hold fluid separate and apart from inner cavity  721 , which may, itself, be inflatable to press against an inner surface of outer tread  723 . In so doing, inner cavity  721  may either increase or put the fluid in outer tread  723  under pressure, which may aid in the ejection of the fluid from each injection head  724 . Inner portion  729  may include an inner bladder that may be deflated to permit easy movement of multi-head body  720  through catheter  705  to a target tissue site once positioned, multi-head body  720  may be extended out of catheter  705  and inner portion  729  may be inflated/expanded to permit outer tread surface  723  to rotate around inner portion  729  and eject fluid through multiple injection heads  724 . The injections head  724  may also be configured and operate in other fashions, such as those described above for  FIGS. 3 ,  5 , and  21 . 
     The heads  724  may be sized to fit within a 9 French or larger catheter. Conversely, the multi-head delivery body  720  may also have a height and width greater than a 9 French when it is inflated. Inner portion  729  having a constant size and shape. 
       FIG. 8  is a top view of multi-head delivery device of  FIG. 7 . As can be seen, elongate shaft  710  may be longitudinally aligned with multi-head delivery body  720  and may have a symmetrical end section  713 , the end section including substantially perpendicular sections  715 ,  815 . Sections  715  and  815  may extend past first side surface  722  and second side surface  822  and may be coupled to final distal sections  717 ,  817 . 
     As also shown in  FIG. 8 , multi-head delivery body  720  may have multiple rows of offset injection heads  724 . However, the injection heads shown elsewhere may also be used in this and other embodiments. 
     As shown in  FIG. 8 , elongate shaft  710  may be asymmetrical, similar to  FIG. 4 , and may only include end section  713 . Distal end  711  may be rigidly coupled to and co-axially aligned with axle  716 , which may be co-axially aligned with axle  316 . Asymmetrical end section  713  may also be in fluid communication with inner cavity  721 . 
       FIG. 9  is a cross-sectional side view of a portion of the distal end of a catheter in accord with an embodiment of the present invention. In  FIG. 9 , a catheter  905  having a proximal end  906 , a distal end  907  and a lumen  908  extending there between, is shown disposed within lumen  908  of multi-head delivery device  900 . Multi-head delivery device  900  may include an elongate shaft  910  having a proximal end, a distal end, and a lumen extending there between. A multi-head delivery body  920  may have an inner cavity  921  similar to delivery body  320  from  FIG. 3 . It may also have multiple injection heads  924  in fluid communication with inner cavity  921 . Multi-head delivers device  900  may also include a control mechanism  930  to spread and close multiple injection heads  924  of multi-head delivery body  920 . For example, control mechanism  930  may include push and pull wires and/or a mechanism similar to an umbrella to permit closing the multiple injection heads  924  and to permit the transport of the multi-head delivery device  900  through lumen  908 . As in  FIG. 3 , in  FIG. 9 , the lumen of elongate shaft  910  may be rotably coupled to and, co-axially aligned with inner cavity  921  in multi-head delivery body  920 . 
       FIG. 10  is a cross-sectional side view of the distal end of the catheter and multi-head delivery device of  FIG. 9 . In  FIG. 10 , the multi-head delivery body extends past the distal end of the catheter and is shown fully open. As can be seen, the multi-head delivery body  920  may be extended past distal end  907  of catheter  905  and multiple thin injection heads  924  may be extended using control mechanism  930 . Moreover, multi-head delivery body  920  may rotate around distal end  911  of elongate shaft  910  and may receive fluid from inner cavity  921 . This fluid may be ejected out a distal end of each injection head  924 . 
       FIG. 11  is a cross-sectional side view of a portion of the distal end of the catheter and the multi-head delivery device from  FIG. 9 . In  FIG. 11  the multi-head delivery body is retracted back into the distal end of the catheter so that it may move toward the proximal end of the catheter. In  FIG. 11 , multi-head delivery body  920  may be retracted back into distal end  907  of catheter  905  and multiple thin injection heads  924  may be collapsed in the opposite direction of  FIG. 9 , which is similar to an umbrella that has been opened past the desired normal open position. Multiple injection heads  924  may be designed to permit movement in this opposite direction to ease movement of the multi-head delivery body  920  back into distal end  907 . In another embodiment of the present invention, control mechanism  930  may also permit closing the  924  back into the configuration shown in  FIG. 9 . However, bringing multi-head delivery body  920  back into distal end  907  of catheter  905  in this position may be more difficult than in the configuration shown in  FIG. 11 . 
       FIG. 12  is a perspective view of a distal end of a multi-head delivery device in accord with an embodiment of the present invention. In  FIG. 12 , a multi-head delivery device  1200  along with an elongate shaft  1210 , a distal end  1211 , a lumen  1212 , a multi-part delivery body  1220 , an inner cavity  1221 , injection heads  1224 , and exterior surface  1223  may all be seen. Multiple injection heads  1224  may be configured similarly to those described in  FIGS. 3-6  and  21 . Distal end  1211  may include a semi-rigid and/or rigid symmetrical forked section  1213  that may be rotably coupled to and co-axially aligned with an axis of multi-head delivery body  1220 . Embodiments of multi-head delivery body  1220  are also contemplated in which the outer diameter of multi-head delivery body  1220  may fit within a 9 french or larger catheter and the length of multi-head delivery body  1220  may be approximately 1 cm. Embodiments of multi-head delivery body  1220  are also contemplated in which multi-head delivery body  1220  may be moved longitudinally through a catheter. For example, multi-head delivery body  1220  may need to be enclosed in a sheath (not shown) to help hold multi-head delivery body  1220  and forked section  1213  in a contracted position. The sheath may help to prevent the injection heads  1224  from catching on and damaging a lumen of the catheter through which multi-head delivery body  1220  may be moved. 
     Upon extending multi-head delivery body  1220  past a distal end of the catheter, the sheath may be removed, and forked section  1213  may unfold as shown in  FIG. 12 . Once multi-head delivery body  1220  has been positioned over a target tissue site, it may be rolled across the target tissue site to deliver therapeutic through injection heads  1224 . After delivering the therapeutic, multi-head delivery body  1220  may be retracted back into a distal end of the catheter. The multi-head delivery body  1220  may also be retracted back into a distal end of the sheath so that multi-head delivery body  1220  may be removed from a patient within or outside of the catheter. 
     In  FIG. 13 , the multi-head delivery device  1300  may include an elongate shaft  1310 , a distal end  1311 , a lumen  1312 , a multi-head delivery body  1320 , an inner cavity  1321 , and multiple injection heads  1324  spaced in a substantially even pattern around an exterior surface  1323  of multi-head delivery device  1320 . Multiple injection heads  1324  may be configured and operate similar to those described in  FIGS. 3-6  and  21 . In the present embodiment, elongate shaft  1310  may be rotably coupled to and co-axially aligned with multi-head delivery body  1320 . 
     Embodiments of multi-head delivery body  1320  may include a multi-head delivery body that may be moved longitudinally through a catheter. For example, multi-head delivery body  1320  may need to be enclosed in a sheath (not shown) to prevent multiple injection heads  1324  from catching on and damaging a lumen of the catheter through which multi-head delivery body  1320  may be moved. Upon extending multi-head delivery body  1320  past a distal end of the catheter, the sheath may be removed, if present, and multi-head delivery body  1320  may be positioned over a target tissue site and rolled across the target tissue site to deliver a therapeutic through multiple injection heads  1324  that may be provided by lumen  1312  of elongate shaft  1310 . After delivering the therapeutic, multi-head delivery body  1320  may be retracted back into a distal end of the catheter using, for example, elongate shaft  1310  to pull multi-head delivery body  1320  back into the catheter and then remove the catheter and multi-head delivery body  1320  together. In the sheath embodiment, the multi-head delivery body  1320  may also be retracted back into a distal end of the sheath so that multi-head delivery body  1320  may be removed with or without the catheter. 
       FIG. 18  is a side view of a portion of a distal end of a catheter with an alternative multi-head delivery body. In  FIG. 18 , expandable multi-head delivery device  1800  may include an elongated shaft  1810  having a proximal end, a distal end  1811  and a lumen  1812  extending there between. It may also include a symmetrical, collapsible multi-head delivery body  1815  having a first arm  1820  and a second arm  1830 . Lumen  1812  may be in fluid communication with the proximal end of elongated shaft  1810 . First arm  1820  may include a distal arm section  1821  having a distal end  1822  and a proximal end  1823 . First arm distal end  1822  may be pivotally coupled to elongated shaft distal end  1811 . First arm  1820  may also include a proximal arm section  1825  having a distal end  1826  pivotally coupled to distal arm section proximal end  1823  to form a side needle  1828  and a proximal end  1827  slidingly coupled to a section  1816  of elongated shaft  1810 . First arm  1820  may also include a lumen  1829  extending between first arm distal end  1822  and second arm proximal end  1827 , the lumen in fluid communication with elongated shaft lumen  1812 . Second arm  1830  may include a distal arm section  1831  having a distal end  1832  and a proximal end  1833 . Second arm distal end  1832  may be pivotally coupled to elongated shaft distal end  1811  to form a distal needle  1850 . Second arm  1830  may also include a proximal arm section  1835  having a distal end  1836  pivotally coupled to distal arm section proximal end  1833  to form a side needle  1838 . Second arm may also have a proximal end  1837  slidingly coupled to a section  1817  of elongated shaft  1810  near elongated shaft distal end  1811 . Second arm  1830  may also include a lumen  1839  extending between first arm distal end  1832  and second arm proximal end  1837  in fluid communication with elongated shaft lumen  1812 . 
     As can be seen in  FIG. 18  elongated shaft  1810  may be disposed within a catheter  1860  to permit elongated shaft  1810  to be moved to a target tissue site within catheter  1860  thus preventing needles  1828 ,  1838 , and  1850  from substantially injuring tissue in a patient before the distal end of elongated shaft  1810  can be positioned near the target tissue site. As seen in  FIG. 18 , the distal end of elongated shaft  1810  including collapsible multi-head delivery body  1815  is extended out past catheter  1860  distal end  1861  and illustrates collapsible multi-head delivery body  1815  in a partially open position. Movement lines indicate the collapsible multi-needle structure  1815  is being closed. In the closed position, collapsible multi-head delivery body  1815  may abut an exterior surface of elongated shaft  1810  to permit easy movement of elongated shaft  1810  through catheter lumen  1862 . In the closed position elongated shaft lumen  1812  may remain in fluid communication with first arm lumen  1829  and second arm lumen  1839 . This may be done, for example, via proximal end  1827  and/or proximal end  1837  and distal end  1822  and/or distal end  1832 . Alternatively, elongated shaft lumen  1812  may not remain in fluid communication with first arm lumen  1829  and second arm lumen  1839  in the closed position. 
     In accord an embodiment of the present invention a control mechanism may be implemented similar to an umbrella opening and closing mechanism that may be actuated from the proximal end of elongated shaft  1810  to control the opening and closing of collapsible multi-head delivery body  1815 . For example, one or more push/pull wires may be attached to collapsible multi-head delivery body  1815  to permit the opening and closing of collapsible multi-head delivery body  1815  by pushing/pulling one or more of the push/pull wires. Alternatively, collapsible multi-head delivery body  1815  may be biased toward the open position by, for example, a spring-loaded umbrella mechanism that may be opened by a control mechanism  1870  to permit collapsible multi-head delivery body  1815  to open. Similarly, collapsible multi-head delivery body  1815  may open upon being extended past the distal end of catheter  1860  a predetermined distance. Similarly, collapsible multi-needle structure  1815  may also be closed by control mechanism  1870 . Opening may be accomplished by releasing the spring-loaded mechanism and closing may be accomplished by pulling a proximal end of push/pull wire  1870  at the proximal end of catheter  1860  in the proximal direction. Alternatively, fluid pressure (positive or negative) may be used to open or close the device. 
     Although the embodiment shown in  FIG. 18  may only show two arms  1820 ,  1830 , other embodiments are contemplated in which three or more arms, may be implemented. 
       FIG. 19  is a side view of the portion of the distal end of the catheter of  FIG. 18  with the expandable multi-tip injection structure in an expanded position. In  FIG. 19 , the extended position collapsible multi-head delivery body  1815  may be urged distally to inject a target tissue site with needle  1850 . Likewise, collapsible multi-head delivery body  1815  may be urged laterally in one or both directions to inject tissue sites with needle  1828  and/or needle  1838 . 
       FIG. 20  is a flow diagram illustrating a method in accordance with an embodiment of the present invention. In  FIG. 20 , the method may include inserting ( 2010 ) a multi-head delivery device into a catheter and moving the multi-head delivery device to a distal end of the catheter. The method may also include positioning ( 2020 ) the distal end of the catheter substantially adjacent to a target tissue site within a patient and extending ( 2030 ) the multi-head delivery device past the distal end of the catheter. The method may further include engaging ( 2040 ) the target tissue site with the multi-head delivery device heads of the multi-head delivery device into the target tissue site, and moving ( 2050 ) the multi-head delivery device over the target tissue site to deliver a therapeutic to the target tissue site. The method may also further include retracting ( 2060 ) the multi-head delivery device back into the distal end of the catheter and removing ( 2070 ) the distal end of the catheter from the target tissue site. Although the method of  FIG. 3  described above may appear to indicate an exact order of execution of the elements of the method, it is not intended as such. 
     For example, in an embodiment of the present invention, the operation of multi-head delivery body  320  of  FIG. 3  may include inserting ( 2010 ) multi-head delivery body  320  into lumen  116  at the proximal end of catheter  100  of  FIG. 1 , and moving multi-head delivery body  320  to a distal end of catheter  100 . The method may also include positioning ( 2020 ) the distal end of catheter  100  substantially adjacent to a target tissue site within a patient and extending ( 2030 ) multi-head delivery body  320  past the distal end of catheter  100 . The method may further include engaging ( 2040 ) the target tissue site with multi-head delivery body  320 , for example inserting some number of multiple injection heads  324  of multi-head delivery body  320  into the target tissue site, and moving (i.e., rolling) ( 2050 ) multi-head delivery body  320  over the target tissue site to deliver a therapeutic to the target tissue site. This may include rolling ( 2050 ) multi-head delivery body  320  across the target tissue site once as well multiple times to provide the coverage deemed necessary by the practitioner. The method may still further include retracting ( 2060 ) multi-head delivery body  320  back into the distal end of catheter  100  and removing ( 2070 ) the distal end of catheter  100  from the target tissue site. In the present embodiment, the therapeutic may be introduced into lumen  312  of elongated shaft  310  either prior to or after inserting ( 2010 ) multi-head delivery body  320  into catheter  100 , extending ( 2030 ) multi-head delivery body  320  past the end of catheter  100  or engaging ( 2030 ) the target tissue site. 
       FIG. 22  is another alternative embodiment of the present invention. In this embodiment the multi-head delivery device  2200  includes an outer disc  2204  and an inner disc  2202 ; the inner disc having a port  2203  and the outer disc having several delivery heads  2205 . Both the inner disc and the outer disc may rotate about the support  2201 . When the port  2203  of the inner disc aligns with a delivery head  2205 , therapeutic within the inner disc may be released through the port  2203  and the head  2205 . This therapeutic may be stored within the disc as well as be supplied to the inner disc through the support  2201 . 
     A detailed description of embodiments of catheter assemblies that may be used in embodiments of the present invention may be found in co-pending U.S. patent application Ser. No. 09/635,083, filed by the same assignee on Aug. 8, 2000, and entitled “Catheter Shaft Assembly.” 
     The term “therapeutic agent” as used herein may include one or more “therapeutic agents” or “drugs.” The terms “therapeutic agents” and “drugs” are used interchangeably herein and may include pharmaceutically active compounds, nucleic acids with and without carrier vectors such as lipids, compacting agents (such as histones), virus (such as adenovirus, andenoassociated virus, retrovirus, lentivirus and α-virus), polymers, hyaluronic acid, proteins, cells and the like, with or without targeting sequences. 
     The therapeutic agent may be any pharmaceutically acceptable agent such as a non-genetic therapeutic agent, a biomolecule, a small molecule, or cells. 
     Exemplary non-genetic therapeutic agents include anti-thrombogenic agents such heparin, heparin derivatives, prostaglandin (including micellar prostaglandin E1), urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone); anti-proliferative agents such as enoxaprin, angiopeptin, sirolimus (rapamycin), tacrolimus, everolimus, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid; anti-inflammatory agents such as dexamethasone, rosiglitazone, prednisolone, corticosterone, budesonide, estrogen, estrodiol, sulfasalazine, acetylsalicylic acid, mycophenolic acid, and mesalamine; anti-neoplastic/anti-proliferative/anti-mitotic agents such as paclitaxel, epothilone, cladribine, 5-fluorouracil, methotrexate, doxorubicin, daunorubicin, cyclosporine, cisplatin, vinblastine, vincristine, epothilones, endostatin, trapidil, halofuginone, and angiostatin; anti-cancer agents such as antisense inhibitors of c-myc oncogene; anti-microbial agents such as triclosan, cephalosporins, aminoglycosides, nitrofurantoin, silver ions, compounds, or salts; biofilm synthesis inhibitors such as non-steroidal anti-inflammatory agents and chelating agents such as ethylenediaminetetraacetic acid, O,O′-bis (2-aminoethyl)ethyleneglycol-N,N,N′,N′-tetraacetic acid and mixtures thereof; antibiotics such as gentamycin, rifampin, minocyclin, and ciprofolxacin; antibodies including chimeric antibodies and antibody fragments; anesthetic agents such as lidocaine, bupivacaine, and ropivacaine; nitric oxide; nitric oxide (NO) donors such as lisidomine, molsidomine, L-arginine, NO-carbohydrate adducts, polymeric or oligomeric NO adducts; anti-coagulants such as D-Phe-Pro-Arg chloromethyl ketone, an RGD peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, enoxaparin, hirudin, warfarin sodium, Dicumarol, aspirin, prostaglandin inhibitors, platelet aggregation inhibitors such as cilostazol and tick antiplatelet factors; vascular cell growth promotors such as growth factors, transcriptional activators, and translational promotors; vascular cell growth inhibitors such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin; cholesterol-lowering agents; vasodilating agents; agents which interfere with endogeneus vascoactive mechanisms; inhibitors of heat shock proteins such as geldanamycin; and any combinations and prodrugs of the above include statins, β-blockers, and ACE inhibitors. 
     Exemplary biomolecules include peptides, polypeptides and proteins; oligonucleotides; nucleic acids such as double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), and ribozymes; genes; carbohydrates; angiogenic factors including growth factors; cell cycle inhibitors; and anti-restenosis agents. Nucleic acids may be incorporated into delivery systems such as, for example, vectors (including viral vectors), plasmids or liposomes. 
     Non-limiting examples of proteins include monocyte chemoattractant proteins (“MCP-1) and bone morphogenic proteins (“BMPs”), such as, for example, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7 (OP-1), BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15. Preferred BMPS are any of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, and BMP-7. These BMPs can be provided as homdimers, heterodimers or combinations thereof, alone or together with other molecules. Alternatively, or in addition, molecules capable of inducing an upstream or downstream effect of a BMP can be provided. Such molecules include any of the “hedghog” proteins, or the DNA&#39;s encoding them. Non-limiting examples of genes include survival genes that protect against cell death, such as anti-apoptotic Bcl-2 family factors and Akt kinase and combinations thereof. Non-limiting examples of angiogenic factors include acidic and basic fibroblast growth factors, vascular endothelial growth factor, epidermal growth factor, transforming growth factor α and β, platelet-derived endothelial growth factor, platelet-derived growth factor, tumor necrosis factor α, hepatocyte growth factor, and insulin like growth factor. A non-limiting example of a cell cycle inhibitor is a cathespin D (CD) inhibitor. Non-limiting examples of anti-restenosis agents include p15, p16, p18, p19, p21, p27, p53, p57, Rb, nFkB and E2F decoys, thymidine kinase (“TK”) and combinations thereof and other agents useful for interfering with cell proliferation. 
     Exemplary small molecules include hormones, nucleotides, amino acids, sugars, and lipids and compounds have a molecular weight of less than 100 kD. 
     Exemplary cells include stem cells, progenitor cells, endothelial cells, adult cardiomyocytes, and smooth muscle cells. Cells can be of human origin (autologous or allogenic) or from an animal source (xenogenic), or genetically engineered. 
     Any of the therapeutic agents may be combined to the extent such combination is biologically compatible. 
     Any of the above mentioned therapeutic agents may be incorporated into a polymeric coating on the medical device or in the medical device. The polymers may be biodegradable or non-biodegradable. Non-limiting examples of suitable non-biodegradable polymers include polyvinylpyrrolidone including cross-linked polyvinylpyrrolidone; polyvinyl alcohols, copolymers of vinyl monomers such as EVA; polyvinyl ethers; polyvinyl aromatics; polyethylene oxides; polyesters including polyethylene terephthalate; polyamides; polyacrylamides; polyethers including polyether sulfone; polyalkylenes including polypropylene, polyethylene and high molecular weight polyethylene; polyurethanes; polycarbonates, silicones; siloxane polymers; cellulosic polymers such as cellulose acetate; polymer dispersions such as polyurethane dispersions (BAYHDROL®); squalene emulsions; and mixtures and copolymers of any of the foregoing. 
     Non-limiting examples of suitable biodegradable polymers include polycarboxylic acid, polyanhydrides including maleic anhydride polymers; polyisobutylene copolymers and styrene-isobutylene-styrene block copolymers such as styrene-isobutylene-styrene tert-block copolymers (SIBS); polyorthoesters; poly-amino acids; polyethylene oxide; polyphosphazenes; polylactic acid, polyglycolic acid and copolymers and mixtures thereof such as poly(L-lactic acid) (PLLA), poly(D,L,-lactide), poly(lactic acid-co-glycolic acid), 50/50 (DL-lactide-co-glycolide); polydioxanone; polypropylene fumarate; polydepsipeptides; polycaprolactone and co-polymers and mixtures thereof such as poly(D,L-lactide-co-caprolactone) and polycaprolactone co-butylacrylate; polyhydroxybutyrate valerate and blends; polycarbonates such as tyrosine-derived polycarbonates and arylates, polyiminocarbonates, and polydimethyltrimethylcarbonates; cyanoacrylate; calcium phosphates; polyglycosaminoglycans; macromolecules such as polysaccharides (including hyaluronic acid; cellulose, and hydroxypropylmethyl cellulose; gelatin; starches; dextrans; alginates and derivatives thereof), proteins and polypeptides; and mixtures and copolymers of any of the foregoing. The biodegradable polymer may also be a surface erodable polymer such as polyhydroxybutyrate and its copolymers, polycaprolactone, polyanhydrides (both crystalline and amorphous), maleic anhydride copolymers, and zinc-calcium phosphate. 
     In a preferred embodiment, the polymer is polyacrylic acid available as HYDROPLUS® (Boston Scientific Corporation, Natick, Mass.), and described in U.S. Pat. No. 5,091,205, the disclosure of which is incorporated by reference herein. In a more preferred embodiment, the polymer is a co-polymer of polylactic acid and polycaprolactone. 
     Such coatings used with the present invention may be formed by any method known to one in the art. For example, an initial polymer/solvent mixture can be formed and then the therapeutic agent added to the polymer/solvent mixture. Alternatively, the polymer, solvent, and therapeutic agent can be added simultaneously to form the mixture. The polymer/solvent mixture may be a dispersion, suspension or a solution. The therapeutic agent may also be mixed with the polymer in the absence of a solvent. The therapeutic agent may be dissolved in the polymer/solvent mixture or in the polymer to be in a true solution with the mixture or polymer, dispersed into fine or micronized particles in the mixture or polymer, suspended in the mixture or polymer based on its solubility profile, or combined with micelle-forming compounds such as surfactants or adsorbed onto small carrier particles to create a suspension in the mixture or polymer. The coating may comprise multiple polymers and/or multiple therapeutic agents. 
     The coating can be applied to the medical device by any known method in the art including dipping, spraying, rolling, brushing, electrostatic plating or spinning, vapor deposition, air spraying including atomized spray coating, and spray coating using an ultrasonic nozzle. 
     The coating on the medical device is typically from about 1 to about 50 microns thick. In the case of balloon catheters, the thickness is preferably from about 1 to about 10 microns, and more preferably from about 2 to about 5 microns. Very thin polymer coatings, such as about 0.2-0.3 microns and much thicker coatings, such as more than 10 microns, are also possible. It is also within the scope of the present invention to apply multiple layers of polymer coatings onto the medical device. Such multiple layers may contain the same or different therapeutic agents and/or the same or different polymers. Methods of choosing the type, thickness and other properties of the polymer and/or therapeutic agent to create different release kinetics are well known to one in the art. 
     The medical device may also contain a radio-opacifying agent within its structure to facilitate viewing the medical device during insertion and at any point while the device is implanted. Non-limiting examples of radio-opacifying agents are bismuth subcarbonate, bismuth oxychloride, bismuth trioxide, barium sulfate, tungsten, and mixtures thereof. 
     The present invention may include designs that use catheters manufactured by Boston Scientific of Natick, Mass. including the Stiletto™ catheter. Likewise, embodiments of the present invention may also use catheters with and without hoods, with and without an electrode sensor tip, and with combinations of the above-described features in catheters with and without deflectable tips. 
     Still further, the present invention may include a body with multiple heads spaced over an exterior surface of the body. The multiple heads may be spaced evenly, randomly and/or in a specific pattern over on exterior surface of the body. For example, the multi-head delivery device may include a cylindrically shaped body with the multiple heads being arranged in evenly spaced longitudinal rows and evenly spaced circumferentially arranged columns or the multiple heads may be arranged in evenly spaced and offset longitudinal rows so that heads in every other row may be aligned with each other. The multiple heads may provide for the injection or other delivery of therapeutic from within the multi-head delivery device as well as be made of a solid therapeutic that may break off as each head is inserted into a target area. 
     The multi-head delivery device may permit the rapid deployment of therapeutic agents over a tissue area by rolling, for example, the device across the area. This may be especially useful when a large area of tissue needs to be dosed with the therapeutic agent while the multi-head device is positioned inside a patient&#39;s body. This can reduce procedural time and costs due to the large tissue area that may be quickly treated with embodiments of the present invention. 
     Although the present invention has been disclosed in detail, it should be understood that various changes, substitutions, and alterations may be made herein, the present invention is intended to cover various modifications of each embodiment as well as between embodiments. Other examples are readily ascertainable from the above description and may be made without departing from the spirit and scope of the present invention.