Device for delivering biological agents

Information

  • Patent Grant
  • 6659996
  • Patent Number
    6,659,996
  • Date Filed
    Monday, September 27, 1999
    25 years ago
  • Date Issued
    Tuesday, December 9, 2003
    21 years ago
Abstract
A biological agent delivery device for delivering biological agents includes a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end. A flexible pouch formed in the sheath wall for containing a biological agent is capable of being displaced radially outwardly for radially displacing the biological agent.
Description




BACKGROUND OF THE INVENTION




Much effort has been expended in recent years to find an effective and superior way of administering drugs to patients' bodies. Products such as the transdermal patch and once-a-day orally administered pills that more precisely deliver drugs have been developed. Such products are a boon to patients for they boost the effectiveness of the drugs and limit side effects by precisely controlling how quickly drugs are released in the body; by keeping drugs at a constant level and by delivering them exactly where needed.




One such development is the injection or implantation of drugs in the form of in microscopic particles or pellets at a disease site. The drugs are encapsulated in polymers or fatty compounds, such as liposomes which permit slow release of the encapsulated drug over time thereby potentially lowering the drugs toxicity.




In addition, there are times when it is desirable to deliver a biological agent that is in a non-conventional form to a disease site such as a drug in a loose particulate form, or a quantity of cells, cell clusters or cellular extracts in a bibcompatible solution. A particulate biological agent can be in a granular, powdered, or microsphere form. The problem with biological agents in these forms is that they are difficult to properly deliver to a diseased tissue site.




SUMMARY OF THE INVENTION




The present invention provides a novel device with a distal end insertable into the tissue or a body cavity of a patient for delivering both particulate and liquid biological agents in a quick, predictable, safe and easy manner without damaging the biological agent. This is important in the delivery of cells or microspheres.




The present invention is directed to a biological agent delivery device including a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end. A flexible pouch formed in the sheath wall for containing a biological agent is capable of being displaced radially or laterally outwardly for radially displacing the biological agent.




In preferred embodiments, a displacement member is disposed within the sheath for causing displacement of the pouch radially with respect to the sheath to radially or laterally deliver the biological agent. The sheath is flexible and the pouch is preformed in the sheath wall. A guide wire extends within the sheath for guiding the delivery device. Preferably, the pouch system encircles the sheath. In one preferred embodiment, the displacement member includes a spring member. In another preferred embodiment, the displacement member includes a volume of fluid. The volume of fluid can be either a liquid or a gas. Optionally, a light source is included for directing light within the sheath. The light is transmitted to the tip of the delivery device by the fluid within the sheath. In yet another embodiment, the light is transmitted to the tip of the delivery device by a fiber optic disposed within the sheath. The tip is formed in a manner to produce or deliver a desired pattern of light. In still another preferred embodiment, a balloon extends from the sheath for controlling fluid flow within body cavities.











BRIEF DESCRIPTION OF THE DRAWINGS




The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.





FIG. 1

is a plan view of a preferred biological agent delivery device.





FIG. 2

is a side sectional view of the biological agent delivery device of

FIG. 1

with the distal end of the device inserted into tissue.





FIG. 3

is a side sectional view of the distal end of the biological agent delivery device with the outer tube


102


retracted to expose the cannula notch


104




b


and the support surface


105




a


of the flexible membrane


105


.





FIGS. 4 and 5

are side sectional views of the distal end of the biological agent delivery device of

FIG. 2

depicting the delivery of a quantity of a biological agent to a tissue site.





FIGS. 6 and 7

are side sectional views of the distal end of another preferred biological agent delivery device depicting the delivery of a quantity of a biological agent to a tissue site.





FIG. 8

is a side sectional view of the distal end of yet another preferred biological agent delivery device.





FIG. 9

is a side sectional view of the distal end of still another preferred biological agent delivery device.





FIG. 10

is a side sectional view of the distal end of still another preferred biological agent delivery device.





FIG. 11

is a side schematic view of a preferred biological agent delivery catheter.





FIG. 12

is a side schematic view of the catheter of

FIG. 11

positioned within a body passage with the pouches displaced laterally outward to release the biological agents.





FIG. 13

is a side sectional view of another preferred biological agent delivery catheter.





FIG. 14

is a side-sectional view of still another preferred biological agent delivery catheter.





FIG. 15

is a side view of another preferred pouch arrangement.





FIG. 16

is a side-sectional view of still another preferred pouch arrangement.





FIG. 17

is a cross-sectional view of yet another preferred pouch arrangement.











DETAILED DESCRIPTION OF THE INVENTION




Referring to

FIGS. 1 and 2

, biological agent delivery device


100


is an apparatus suitable for single-handed subcutaneous delivery of a biological agent


106


such as a quantity of a loose particulate drug, or a quantity of cells, cell clusters or cellular extracts in solution with a biological compatible carrier. For purposes of illustrating the invention, we have selected a delivery device similar to the device disclosed in U.S. Pat. No. 5,562,613 which is incorporated herein by reference in its entirety. However, other mechanisms for inserting and retracting the various members may substitute therefore. Additionally, for illustration purposes, the biological agent


106


depicted in the drawings is a particulate drug.




Delivery device


100


has a housing


12


with a pair of finger grips


14


extending transverse the longitudinal axis of the housing. A driving member


16


is slideably engaged with a track


20


formed along the longitudinal length of housing


12


. The housing


12


has an external cylindrical bore


18


formed therein which extends along the longitudinal axis of the housing


12


. A tubular member or cannula


104


, having an internal bore


104




c


is mounted within the external cylindrical bore


18


and extends along the longitudinal axis of bore


18


. A piston


108


is shown disposed within internal bore


104




c


. Cannula


104


has a solid distal tip


104




a


which is angled for penetration into tissue. A radially lateral opening in the cannula


104


near tip


104




a


forms a cannula notch


104




b


(FIG.


3


). An outer tube


102


is secured to housing


12


and is mounted concentrically about cannula


104


. Cannula


104


is axially slideable relative to cylindrical bore


18


and outer tube


102


for extending or retracting cannula


104


relative to outer tube


102


in order to enclose or expose cannula notch


104




c


. A flexible membrane


105


having a collapsible support surface


105




a


, a tubular portion


105




b


and a closed distal end


105




c


is positioned coaxially within bore


104




c


of cannula


104


. The distal end


105




c


of membrane


105


extends into cannula notch


104




b


and abuts the distal end


103


of cannula notch


104




b


. Flexible membrane


105


extends across the opening of cannula notch


104




b


and prevents bore


104




c


from communicating with regions outside cannula


104


through cannula notch


104




b


. Piston


108


is mounted coaxially within the tubular portion


105




b


of the flexible membrane


105


. Piston


108


is axially slideable relative to cannula


104


and tubular portion


105




b


and acts as a displacement member for radially, laterally displacing support surface


105




a


. Since the bore


104




c


within cannula


104


terminates at the distal end


103


of cannula notch


104




b


, piston


108


is restricted from extending past cannula notch


104




b.






The support surface


105




a


of flexible membrane


105


is located near the distal end


105




c


of the membrane


105


for supporting a quantity of a biological agent


106


. The support surface


105




a


is changeable from an undisplaced or collapsed position to a displaced position. When membrane


105


is an undisplaced position, support surface


105




a


is indented downwardly (or inwardly) into flexible membrane


105


to form a pouch with support surface


105




a


contacting the opposite side of the membrane


105


. The pouch is typically formed by pushing support surface


105




a


downwardly (inwardly). The support surface


105




a


provides the surfaces of the pouch. Alternatively, the pouch can be preformed into membrane


105


such as by molding. When membrane


105


is in a displaced position, the pouch disappears with the support surface


105




a


being relatively horizontal. Membrane


105


is preferably formed from a flexible polymeric material which can either be stretchable or non-stretchable and can be transparent. Alternatively, membrane


105


can also be formed from other suitable flexible materials such as fabrics. Although tubular portion


105




b


is typically flexible, alternatively, tubular portion


105




b


can be rigid with only the support surface


105




a


being flexible.




The piston


108


and cannula


104


are secured at their respective proximal ends by a piston grip


48


, and a cannula grip


50


. The proximal end of tubular portion


105




b


of membrane


105


of has a flange


105




d


which secures tubular portion


105




b


to cannula


104


at the proximal end of cannula grip


50


. Additionally, if needed, tubular portion


105




b


can be bonded within bore


104




c


with an adhesive. The piston grip


48


and cannula grip


50


are disc-shaped with a diameter which approximates the diameter of the cylindrical bore. The piston grip


48


and the cannula grip


50


are slideably engaged within the housing bore


18


. The piston grip


48


and cannula grip


50


have respective channels formed therein through which drive pins


32


and


34


respectively extend for engagement with the proximal ends of the piston


108


and cannula


104


respectively.




Piston drive pin


32


and cannula drive pin


34


both extend through a single elongate slot


128


in housing


12


. Housing slot


128


has a notch


128




a


located at its distal end for engaging cannula drive pin


34


when cannula drive pin


34


is in the advanced position. Piston drive pin


32


extends through driving member


16


through a hole


32




a


. Cannula drive pin


34


extends through driving member


16


through an elongate driving member slot


126


. Driving member slot


126


has a notch


126




a


located at its distal end for engaging cannula drive pin


34


.




The piston


108


, cannula


104


and outer tube


102


are preferably formed of rigid sterilizable material such as stainless steel. Other components of the device, including the housing, driving member, piston and cannula grips, etc. are preferably made from low cost plastic material. The use of molded plastic components for the manufacture of the instrument is preferred to lower the cost so that the device can be disposed of after use.




In operation, in order to subcutaneously deliver a quantity of a biological agent


106


to a desired tissue site, the surface


112




a


of tissue


112


is first cut with a scalpel. The tip


104




a


of cannula


104


is then inserted into the incision within tissue


112


while driving member


16


is in a retracted position and the distal end


101


of delivery device


100


is advanced into tissue


112


until reaching a desired location. When driving member


16


is in a retracted position, cannula notch


104




b


is enclosed by outer tube


102


with the tip of piston


108


being at the proximal end of cannula notch


104




b


. Outer tube


102


protects the biological agent


106


and prevents it from spilling out of cannula notch


104




b


prematurely. Alternatively, tip


104




a


of cannula


104


can be inserted into tissue


112


by puncturing the surface


112




a


of tissue


112


with tip


104




a.






Driving member


16


is then moved distally along track


20


toward the distal end


101


of delivery device


100


. Cannula drive pin


34


is engaged within notch


126




a


of driving member slot


126


and piston drive pin


32


is engaged by hole


32




a


. As the driving member


16


is advanced, cannula


104


is extended from outer tube


102


such that cannula notch


104




b


and the biological agent


106


are exposed beyond the tip


102




a


of outer tube


102


as seen in FIG.


4


. At the same time, driving member


16


advances piston


108


by engaging piston drive pin


32


with hole


32




a


such that the cannula


104


and the piston


108


advance together in unison. Cannula


104


is extended until cannula drive pin


34


reaches the distal end of housing slot


128


where cannula drive pin


34


engages housing slot notch


128




a.






As driving member


16


is further advanced, cannula drive pin


34


disengages from notch


126




a


in driving member slot


126


and piston drive pin


32


is advanced further, thereby advancing piston


108


forward relative to cannula


104


. As piston


108


is extended into cannula notch


104




b


, piston


108


laterally displaces the support surface


105




a


of membrane


105


thereby laterally displacing the biological agent


106


from cannula notch


104




b


into the surrounding tissue


112


as seen in FIG.


5


. Piston


108


is extended into cannula notch


104




b


until the proximal end of driving member slot


126


reaches cannula drive pin


34


, thereby preventing further advancement of driving member


16


. Further advancement of piston


108


is also prevented by the distal end


103


of cannula notch


104




b.






Once the biological agent


106


is deposited into tissue


112


, the distal end


101


of delivery device


100


can be removed from tissue


112


. To remove distal end


101


from the tissue


112


, the cannula


104


and the piston


108


are first retracted relative to outer tube


102


by retracting driving member


16


. This leaves behind the biological agent


106


within tissue


112


. Distal end


101


of delivery device


100


is then pulled from tissue


112


leaving behind a small puncture wound.





FIGS. 6 and 7

depict the distal end of biological agent delivery device


130


which is another preferred embodiment of the present invention differing from delivery device


100


in that piston


108


and the components associated with advancing and retracting piston


108


are omitted. Instead, in order to deliver a biological agent


106


, a fluid


107




a


such as a gas or a liquid is introduced into cavity


107


within membrane


105


to serve as a displacement member in order to laterally displace the support surface


105




a


. If desired, the fluid can outwardly displace support surface


105




a


past the outer surface of cannula


104


thereby forming an outward bulge in membrane


105


. The fluid is preferably air if a gas is employed or saline solution if a liquid is employed and is preferably introduced into cavity


107


by a piston/plunger type mechanism or a closed loop pump mechanism within or attached to delivery device


130


. Such a mechanism can be a syringe-type device or a calibrated ampoule-type device. Alternatively, the fluid can be introduced from a reservoir by a pump or from a pressurized tank and can be any other suitable gas or liquid.




Referring to

FIGS. 8 and 9

, flexible membrane


117


differs from flexible membrane


105


in that it does not include a tubular portion


105




b


but consists of a flexible membrane extending across and sealed over the lateral opening of cannula notch


104




b


. As a result, in the embodiment shown in

FIG. 8

, the piston


108


contacts and slides within bore


104




c


of cannula


104


. In the embodiment depicted in

FIG. 9

, the support surface


105




a


of membrane


117


is laterally displaced by a fluid such as gas or liquid introduced into bore


104




c


of cannula


104


.




Referring to

FIG. 10

, biological agent delivery device


132


is a flexible catheter for insertion into body cavities of a patient. In order to provide flexibility of the catheter, the cannula


104


and outer tube


102


are made of flexible material. As in delivery device


130


, the support surface


105




a


of flexible membrane


105


is displaced by fluid introduced into cavity


107


. Cannula


104


has a blunt tip


115


to facilitate the passage of delivery device


132


through body cavities. Although delivery device


132


is shown to include flexible membrane


105


, alternatively, flexible membrane


117


may be employed instead.




An optional fiber optic bundle


109


including optical fibers


109




a


,


109




b


and


109




c


is positioned within bore


104




c


of cannula


104


alongside tubular portion


105




b


of membrane


105


. Optical fiber


109




c


is directed laterally with respect to cannula


104


to provide light to a desired drug delivery site for optimized drug absorption. Illumination is also useful when delivering cells, subcellular extracts, plasmids or gene products for genetic therapy because it facilitates gene transfer. In addition, other forms of electromagnetic radiation can be delivered by optical fiber


109




c


, for example, ultra-violet light for altering cell membranes or for sterilization, or to increase cell membrane permeability with blue light. Furthermore, optics for viewing the delivery site are provided by laterally positioning optical fiber


109




b


and lens


111


. Finally, optics for forward viewing are provided by optical fiber


109




a


and lens


113


.




The fluids (liquids or gases) employed for displacing the support surface


105




a


in the embodiments depicted in

FIGS. 6

,


7


,


9


and


10


can be temperature controlled over a range of different temperatures for therapeutic purposes. The temperature of the fluid is controlled by a cooling/heating system which is coupled to the fluid delivery system. For example, a cold fluid can be used for cooling the tissue surrounding the delivery site for constricting the capillaries in that tissue so that the delivered biological agent passes into the bloodstream more slowly. Alternatively, a heated fluid can be used for heating the tissue surrounding the delivery site for widening the capillaries so that the delivered biological agent passes into the bloodstream more rapidly. In this manner, the delivery rate of the biological agent can be controlled. In addition, extreme cold or hot fluids can be used to freeze or coagulate tissue, if desired.




Although the present invention biological agent delivery devices of

FIGS. 1-10

have been described above for primarily delivering particulate or liquid biological agents, biological agents in pellet form can also be delivered. The term “biological agent” is meant to encompass any substance that can be introduced into tissue or a body cavity for treating a patient such as drugs, microspheres, cells, cell clusters, cells transfected with foreign DNA, cellular components, cellular extracts or gene products. The term “drug” as used herein is intended to have a broad construction so as to include any type of medication capable of being administered in the manner described herein. When biological agents in a liquid form are delivered, a sealing arrangement can be provided around cannula notch


104




b


to reduce the possibility that liquid will not leak prematurely from cannula notch


104




b


when outer tube


102


encloses cannula notch


104




b.






Referring to

FIGS. 11 and 12

, biological agent delivery catheter


210


is another preferred biological agent delivery device for delivering biological agents


222


. Catheter


210


includes an elongate tubular sheath


212


formed of flexible material. The distal end of sheath


212


terminates at a curved blunt tip


214


. A guide wire


216


for guiding catheter


210


within a body cavity extends within the interior


226


of sheath


212


along the longitudinal axis of sheath


212


and is secured to tip


214


. Two displaceable pouch systems


224




a


and


224




b


for containing and delivering biological agents


222


are positioned near the tip


214


of catheter


210


.




The pouch systems


224




a


/


224




b


are spaced apart from each other along the length of sheath


212


and each include an annular pouch or pocket


220


encircling the circumference of the sheath


212


. The pouches


220


are preferably formed of a thinner, more flexible membrane


252


than sheath


212


and are bonded to the wall


213


of sheath


212


. The pouches


220


are radially inwardly indented into the interior


226


of sheath


212


and can be preformed into this shape. Pouches


220


form recessed regions for containing or storing biological agents


222


away from the outer perimeter of sheath


212


and include a support surface


220




a


for supporting biological agents


222


therein. Opposing edges


215


of the wall


213


of sheath


212


are positioned adjacent to each other which causes the membranes of pouches


220


to form a substantially enclosed inward loop to so that the biological agents


222


do not prematurely spill from the pouches


220


. This protects the biological agents


222


during insertion of the catheter


210


within a body cavity. The biological agents


222


are similar to the biological agents


106


previously described above. A spring member


218


is coupled to tip


214


between the guide wire


216


and the tip


214


for causing the delivery of the biological agents


222


.




Referring to

FIG. 12

, in operation, catheter


210


is inserted within a body lumen or cavity


228


. Catheter


210


is advanced within the cavity


228


while being guided by guide wire


216


until reaching a desired location for the delivery of the biological agents


222


. Release of the spring member


218


causes stretching or lengthening of sheath


212


in the direction of arrow


217


which pulls edges


215


away from each other as shown by arrows


219


and displaces pouches


220


radially or laterally outward into a flattened state relative to the longitudinal axis of sheath


212


. This causes the release of the biological agents


222


radially or laterally outward from catheter


210


relative to the longitudinal axis to the desired treatment location.




Although pouches


220


are preferably formed from a membrane


252


that is bonded to sheath


212


, alternatively, pouches


220


can be integrally formed from the wall


213


of the sheath


212


. In such a case, the pouches


220


would be formed to be more flexible than the surrounding wall


213


.




Referring to

FIG. 13

, biological agent delivery catheter


230


is another preferred catheter. Catheter


230


differs from catheter


210


in that a fluid


232


is introduced into the interior


226


of sheath


212


for lengthening sheath


212


to radially or laterally outwardly displace the pouches


220


of pouch systems


224




a


/


224




b


. Fluid


232


can be a liquid or a gas depending upon the application at hand. Also, depending upon the pressure of fluid


232


, the outwardly displaced pouches


220


can be displaced flush with the wall


213


of sheath


212


or outwardly bulging as depicted in phantom. Tip


214


is formed of an optically transmissive material for transmitting light


234


received from a light source


233


. The light


234


is transmitted through the interior


226


of sheath


212


by fluid


232


. Tip


214


is preferably formed from a solid piece of material that is secured to sheath


212


, but alternatively, can be hollow or integrally formed with sheath


212


. The shape and design of tip


214


is made to produce a desired pattern of transmitted light. As a result, tip


214


can be of other suitable shapes depending upon the application at hand and can include mirrors if desired. Various types of light can be transmitted as previously discussed with respect to FIG.


10


.




Referring to

FIG. 14

, biological agent delivery catheter


240


is another preferred catheter which differs from catheter


230


in that catheter


240


includes a balloon


246


for controlling the flow of fluids such as blood around catheter


240


when catheter


240


is introduced within a passage such as a vein or artery. A central tube


242


is positioned within the interior


226


of sheath


212


, thereby forming an outer annular region


236


into which the fluid


232


is introduced for radially or laterally outwardly displacing the pouches


220


. Tube


242


has an interior region


244


which is coupled in fluid communication with the interior


248


of balloon


246


via passages


250


so that balloon


246


can be inflated independently from the operation of pouch systems


224




a


/


224




b


. Finally, a fiber optic


238


extends within the interior


244


of tube


242


for transmitting light to tip


214


.





FIG. 15

depicts another preferred pouch system


235


which includes a shallow preformed indented annular pouch


236


within sheath


212


. The edges


215


of the wall


213


of sheath


212


are positioned further apart from each other than with pouches


220


. A rupturable membrane


237


having a weakened region


237




a


(for example, perforations) covers pouch


236


to prevent premature release of the biological agents


222


.




Referring to

FIG. 16

, pouch


221


is another preferred pouch which differs from pouch


220


in that instead of being a single annular pouch encircling sheath


212


, pouch


221


is only one of multiple pouches


221


encircling sheath


212


. Membrane


252


is bonded to the edges of a circular or oval opening


254


within sheath


212


. Membrane


252


can be preformed to extend inwardly into the interior


226


of sheath


212


. The biological agent


222


is released when the membrane


252


is displaced outwardly as shown in phantom. A flexible outer sleeve


256


is included which extends around sheath


212


. Sleeve


256


is longitudinally slidable relative to sheath


212


as shown by arrows


258


to cover pouch


221


(shown in phantom) during insertion into a patient to prevent premature release of biological agent


222


. Sleeve


256


is slidably retracted relative to pouch


221


to allow biological agent


222


to be delivered.





FIG. 17

is another preferred pouch system


260


in which the pouches


258


differ from pouch


221


(

FIG. 16

) in that pouches


258


are integrally formed from the wall


213


of sheath


212


. The sheath can be hardened in the areas surrounding the pouches


258


so that the pouches


258


remain flexible. In order to prevent premature release of the biological agents


222


, the rupturable membrane


237


(

FIG. 15

) or the slidable outer sleeve


256


(

FIG. 16

) can be employed. Although four pouches


258


are depicted to encircle the circumference of sheath


212


, alternatively more than four or less than four can be employed. The number of pouches


258


can be determined by the diameter of sheath


212


.




While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. For example, other mechanisms can be employed for advancing and retracting cannula


104


and piston


108


. Such mechanisms can include motor or hand-operated gears and power screws, or fluid operated cylinders. In addition, the present invention delivery devices and catheters can be employed for implanting non-therapeutic, solid or rigid objects into tissue or body cavities such as tracking devices, radio transmitters or pumps. Furthermore, various features of the above discussed delivery devices and catheters can be combined or omitted.



Claims
  • 1. A biological agent delivery device comprising:a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end; and a flexible circumferential pouch system formed in the sheath wall and encircling the sheath including at least one annular pouch, the pouch system having a closed position and a open position, the closed position for containing a biological agent in a circular manner about the sheath and the open position for displacing the biological agent outwardly in a circular manner.
  • 2. The delivery device of claim 1 further comprising a displacement member disposed within the sheath for causing displacement of the pouch system radially with respect to the sheath to deliver the biological agent.
  • 3. The delivery device of claim 2 in which the displacement member comprises a spring member for elongating the sheath.
  • 4. The delivery device of claim 1 in which the displacement member comprises a volume of fluid.
  • 5. The delivery device of claim 4 in which the fluid is a liquid.
  • 6. The delivery device of claim 5 in which the fluid is a gas.
  • 7. The delivery device of claim 4 further comprising a light source for directing light within the sheath, the fluid capable of transmitting the light to the tip.
  • 8. The delivery device of claim 7 in which the tip is formed to produce a desired pattern of light.
  • 9. The delivery device of claim 1 further comprising:a light source for directing light within the sheath; and a fiber optic disposed within the sheath for transmitting the light to the tip.
  • 10. The delivery device of claim 1 further comprising a balloon extending from the sheath for controlling fluid flow within body cavities.
  • 11. The delivery device of claim 1 in which the pouch system is preformed.
  • 12. The delivery device of claim 11 in which the sheath is flexible and the pouch system is preformed in the sheath wall.
  • 13. The delivery device of claim 12 further comprising a guide wire extending within the sheath for guiding the delivery device.
  • 14. A biological agent delivery catheter comprising:a flexible sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end; a radially facing flexible circumferential pouch system formed in the sheath wall and encircling the sheath including at least one annular pouch, the pouch system having a closed position and a open position, the closed position for containing a biological agent in a circular manner about the sheath and the open position for displacing the biological agent outwardly in a circular manner; a guide wire extending within the sheath for guiding the catheter; and a displacement member disposed within the sheath for causing the pouch to be displaced to the open position to deliver the biological agent outwardly in a circular manner.
  • 15. A method of forming a biological agent delivery device comprising the steps of:providing a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end; providing the sheath with a flexible circumferential pouch system including at least one annular pouch for containing a biological agent formed in the sheath wall in a circular manner capable of being displaced radially outwardly circumferentially for radially displacing the biological agent.
  • 16. The method of claim 15 further comprising the step of disposing a displacement member within the sheath for displacing the pouch system radially with respect to the sheath to deliver the biological agent.
  • 17. The method of claim 16 further comprising the step of forming the displacement member from a spring member.
  • 18. The method of claim 15 further comprising the step of forming the displacement member from a volume of fluid.
  • 19. The method of claim 18 further comprising the steps of providing a light source for directing light within the sheath, the fluid capable of transmitting the light to the tip with the fluid.
  • 20. The method of claim 19 further comprising the step of forming the tip to produce a desired pattern of light.
  • 21. The method of claim 15 further comprising the steps of:providing a light source for directing light within the sheath; and disposing a fiber optic within the sheath for transmitting the light to the tip.
  • 22. The method of claim 15 further comprising the step of providing a balloon capable of extending from the sheath for controlling fluid flow within body cavities.
  • 23. The method of claim 15 further comprising the step of preforming the pouch system.
  • 24. The method of claim 23 further comprising the steps of:forming the sheath from flexible material; and preforming the pouch system in the sheath wall.
  • 25. The method of claim 24 further comprising the step of extending a guide wire within the sheath for guiding the delivery device.
  • 26. A method of delivering a biological agent to a tissue site comprising the steps of:providing a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end; containing a biological agent within a flexible circumferential pouch system formed in the sheath wall encircling the sheath including at least one annular pouch, the pouch system having a closed position and a open position, the closed position for containing a biological agent in a circular manner about the sheath and the open position for displacing the biological agent outwardly in a circular manner; inserting the sheath into the tissue site; and radially displacing the pouch outwardly to the open position with a displacement member disposed within the sheath to deliver the biological agent outwardly in a circular manner to the tissue site.
  • 27. A biological agent delivery device comprising:a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end; a flexible pouch formed in the sheath wall for containing a biological agent capable of being displaced radially outwardly for radially displacing the biological agent; and a displacement member comprising a spring member disposed within the sheath for elongating the sheath and causing displacement of the pouch radially with respect to the sheath to deliver the biological agent.
  • 28. A method of forming a biological agent delivery device comprising the steps of:providing a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end; providing the sheath with a flexible pouch for containing a biological agent formed in the sheath wall capable of being displaced radially outwardly for radially displacing the biological agent; and disposing a displacement member formed from a spring member within the sheath for displacing the pouch radially with respect to the sheath to deliver the biological agent.
  • 29. A biological agent delivery device comprising:a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end; and flexible annular pouch formed in the sheath wall and encircling the sheath for containing a biological agent and capable of being displaced radially outwardly for radially displacing the biological agent.
  • 30. A method of delivering a biological agent to a tissue site comprising the steps of:providing a sheath having a longitudinally extending wall surrounding an interior region, and a closed tip at a distal end; containing a biological agent within a flexible annular pouch formed in the sheath wall and encircling the sheath; inserting the sheath into the tissue site; and radially displacing the pouch outwardly with a displacement member disposed within the sheath to deliver the biological agent to the tissue site.
RELATED APPLICATION

This application is a continuation-in-part application of U.S. application Ser. No. 09/266,380, filed Mar. 11, 1999, which is a continuation-in-part application of U.S. application Ser. No. 08/552,467, filed Nov. 9, 1995 now U.S. Pat. No. 5,906,599, the entire teachings of which are incorporated herein by reference.

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Continuation in Parts (2)
Number Date Country
Parent 09/266380 Mar 1999 US
Child 09/405933 US
Parent 08/552467 Nov 1995 US
Child 09/266380 US