Medicament delivery system

• US 6,398,758 B1
• Filed: 02/16/1999
• Issued: 06/04/2002
• Est. Priority Date: 02/16/1999
• Status: Expired due to Term

• Current Assignee: Clark Davis, Stephen C. Jacobsen
• Original Assignee: SARCOS LC (Sarcos Technology & Robotics Corp.)
• Inventors: Davis, Clark, Jacobsen, Stephen C.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/250,736
• Time in Patent Office: 1,204 Days
• Field of Search: 604/890.1, 604/891.1, 604/11-13, 604/15, 604/18, 604/104, 604/285-287, 623/1.11, 623/1.12, 623/1.2, 623/1.32, 623/1.33, 623/1.42, 623/1.43, 606/108, 606/109
• US Class Current: 604/104
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

An apparatus and method for selectively delivering a medicament to a target location of the wall of a body cavity, blood vessel, or the like, comprising a compressed hollow cylinder of permeable, expandable foam, attached to the distal end of a delivery device such as a catheter or catheter guidewire. Using the delivery device, the compressed cylinder is advanced to a target location within the body, and the compressed foam cylinder is allowed to expand so as to contact the walls of the body cavity, blood vessel, or the like, while allowing bodily fluids to freely flow through the central lumen of the cylinder. The foam cylinder is provided with means for perfusing it with a medicament so that the medicament is placed in contact with the walls of the patient'"'"'s anatomy, and is also provided with means for preventing the medicament from entering the patient'"'"'s bloodstream.

Claims

1. A medicament delivery system configured for selectively delivering a medicament to a target location in a body lumen of a patient comprising:

a resilient hollow cylinder of permeable foam, said cylinder having an outer surface, a central lumen, and proximal and distal ends, the cylinder defining proximal and distal openings of the central lumen and a fluid pathway therethrough, enabling fluid flow through the body lumen past the cylinder via the central lumen;

a delivery device configured for introducing the cylinder into the patient'"'"'s body lumen, said delivery device having a proximal end and a distal end, and said cylinder being compressed and attached near the distal end of said delivery device to enable advancement of the cylinder into the patient'"'"'s anatomy for placement adjacent the target location;

a sheath disposed over the cylinder and configured to be pulled open from a distal end thereby allowing for expanding the cylinder within the body cavity, the apparatus being configured to selectively allow said compressed cylinder to expand to contact the walls of the body lumen when said cylinder has been placed adjacent to the target location; and

a medicament absorbed by the hollow cylinder, whereby the medicament is placed in contact with a walls of the body lumen at said target location.

2. An apparatus as described in claim 1, wherein the foam cylinder comprises a material selected from the group consisting of urethane and a hydrophilic material.

3. An apparatus as described in claim 2, further comprising a coating applied to the outer surface of said cylinder, said coating comprising a material selected from the group consisting of:

a hydrophillic material, an anti-thrombogenic material, a permeable anti-thrombogenic membrane material, a material which mechanically stiffens the cylinder, and a coating material which forms an impermeable seal on the surface of said foam material.

4. Apparatus as described in claim 1, further comprising a porous skin formed on the outer surface of said foam cylinder.

5. Apparatus as described in claim 4, further comprising check valves formed in said porous skin to allow medicament to flow out, but prevent fluids from flowing into the foam material.

6. Apparatus as described in claim 5, wherein said porous skin is formed of a hydrophillic urethane material, and said check valves comprise a plurality of flaps formed in said skin.

7. An apparatus as described in claim 1, wherein the delivery device is selected from the group consisting of a catheter and a catheter guidewire.

8. Apparatus as described in claim 7 wherein the means of attachment of said foam cylinder to the distal end of said delivery device comprises at least one tether connected between the distal end of the foam cylinder and the distal end of the delivery device, and at least one tether connected between the proximal end of the foam cylinder and the delivery device, whereby the compressed foam cylinder may be advanced through the patient'"'"'s anatomy as the delivery device is so advanced.

9. Apparatus as described in claim 7 wherein said foam cylinder is attached to the distal end of said delivery device by means of a bonding agent which is soluble in bodily fluids.

10. Apparatus as described in claim 7 wherein the delivery device is a catheter having an opening at its distal end, said distal opening terminating within the foam material, whereby the means for perfusing said cylinder with a medicament comprises introducing a medicament into said catheter and allowing said medicament to flow into said foam material.

11. An apparatus as described in claim 1, further comprising at least one tube extending proximally from the cylinder along the length of the delivery device, said at least one tube having a first end which is configured to extend outside the patient and is configured to receive the medicament, and a second end disposed adjacent the foam cylinder, whereby medicament may be selectively introduced into said first end and through said tube to perfuse said foam cylinder, so as to cause the medicament to be brought into contact with the walls of said body lumen.

12. An apparatus as described in claim 11, comprising two hollow tubes which are configured in each case to extend proximally from the the first end along the length of the delivery device to the second end adjacent the foam cylinder, such that the medicament may be introduced into the first end of the first tube to perfuse said foam cylinder, and may be subsequently drawn from said foam cylinder into the second end of the second tube such that the medicament is circulated through said foam material.

13. Apparatus as described in claim 11 wherein said at least one tube comprises a plurality of perfusion ports in the second end thereof so as to provide multiple medicament entry points into said foam material.

14. An apparatus as described in claim 1, wherein the medicament comprises a drug pre-loaded into the foam material.

15. An apparatus as described in claim 1, wherein the sheath is dissolvable in bodily fluids.

16. An apparatus as described in claim 1 further comprising a tether attached to the distal end of the sheath, wherein the sheath is configured so that it is opened by inverting and pulling said sheath toward the proximal end of said delivery device, so as to remove it from around said compressed cylinder.

17. An apparatus as described in claim 1, wherein the sheath is formed of knit filaments, and at least one filament extends from the distal end of said knit sheath along the delivery device to the proximal end thereof, whereby an operator can pull said filament, causing the knit sheath to unravel and thereby allow the compressed cylinder to expand.

18. An apparatus as described in claim 1, wherein the sheath is formed of at least one helically wrapped filament, and at least one filament extends from the distal end of said sheath along the delivery device to the proximal end thereof, whereby an operator can pull said filament, causing the helical sheath to unwrap and thereby allow the compressed cylinder to expand.

19. An apparatus as described in claim 1, wherein the sheath is formed of braided filaments in tension, and at least one filament extends from the distal end of said sheath along the delivery device to the proximal end thereof, whereby an operator can pull said filament, causing the tension in said braided sheath to be released and thereby allow the compressed cylinder to expand.

20. An apparatus as described in claim 1, wherein said sheath has a sealed distal end and an interior thereof is under vacuum so as to tightly squeeze the foam cylinder within the sheath and maintain the sealed distal end;

the apparatus further comprising a means for releasing the vacuum and means to open the sealed distal end and means to thereafter pull back open said sheath to allow the compressed cylinder to emerge from said sheath and expand within the patient'"'"'s anatomy.

21. Apparatus as described in claim 20, wherein the means for opening the sealed distal end of the sheath comprises means for puncturing the sealed distal end of said sheath so as to cause it to open, said means for puncturing being contained within said sheath.

22. Apparatus as described in claim 1 wherein the foam cylinder has time dependent swelling characteristics, and the means for expanding the cylinder comprises introducing the cylinder into the anatomy and advancing it to the target location before the cylinder swells to its required therapeutic size.

23. An apparatus as described in claim 1, further comprising:

a protrusion extendable from the distal end of said delivery device, said protrusion being contained within said sheath;

said protrusion being extendable toward the distal end of said sheath so as to puncture the sealed distal end of said sheath and cause it to open; and

wherein the delivery device is configured to enable relative movement of the sheath and the foam cylinder so as to enable drawing the sheath proximally and pushing said foam cylinder through the open distal end of said sheath within the patient'"'"'s anatomy.

24. An apparatus as described in claim 3, wherein the coating comprises an antithrombogenic material, and wherein said anti-thrombogenic material is selected from the group consisting of heparin and a hydrophillic material.

25. An apparatus as described in claim 3, wherein the coating comprises a permeable anti-thrombogenic membrane, and the anti-thrombogenic membrane comprises a membrane material selected from the group consisting of:

a hydrophillic polymer film, a micro-porous film, and a polymer film with laser-cut holes.

26. Apparatus as described in claim 1, further comprising means for preventing the medicament from entering the flow of the patient'"'"'s bodily fluids.

27. Apparatus as described in claim 26, wherein the means for preventing the medicament from entering the flow of the patient'"'"'s bodily fluids comprises an impermeable membrane covering at least the central lumen and the end surfaces of the foam cylinder, so as to prevent the medicament from leaking from the foam cylinder.

28. Apparatus as described in claim 27, wherein the portion of said impermeable membrane which covers the end surfaces of the foam cylinder extends onto and covers a portion of the outer surface of said cylinder near each end surface.

29. An apparatus as described in claim 1, further comprising an inner support means disposed within the central lumen of the compressed foam cylinder, configured so as to provide cylindrical support to the cylinder when in its expanded state.

30. An apparatus as described in claim 29 wherein said inner support means is selected from the group consisting of:

a resilient skin covering at least the central lumen and the end surfaces of the foam cylinder;

a helical coil of superelastic ribbon which expands when the foam cylinder is allowed to expand; and

, at least one resilient serpentine coil which expands when the foam cylinder is allowed to expand.

31. Apparatus as described in claim 29 wherein the inner support means is configured to be pulled into a lumen formed in the delivery device for removal from the patient.

32. Apparatus as described in claim 30, wherein said inner support means comprises a plurality of serpentine coils.

33. An apparatus as described in claim 32 wherein the serpentine coils are configured to be pulled into a lumen formed in the delivery device for removal from the patient.

34. Apparatus as described in claim 1 wherein the delivery device comprises a catheter having at least one openable mouth at its distal end, into which the foam cylinder may be retracted for removal from the patient following use.

35. Apparatus as described in claim 1 wherein the end surfaces of the compressed foam cylinder comprise resilient lips configured to provide a seal between the end surfaces of the foam cylinder and a body lumen.

36. An apparatus as described in claim 35 wherein said lips are selected from the group consisting of:

convoluted conical lips;

cylindrical lips;

petal shaped lips; and

lips configured to swell by absorbing fluid.

37. An apparatus as described in claim 35, wherein said lips are spring-loaded.

38. Apparatus as described in claim 35, further comprising a hydrophilic gel disposed over the outer surface of said resilient lips so as to enhance said seal.

39. An apparatus as described in claim 1, further comprising a hydrophillic gel perfused into portions of the foam cylinder adjacent said central lumen and said ends, residing in cells of the foam material and configured to occlude the foam cells when hydrated.

40. An apparatus for selectively delivering a medicament to a target location in a body lumen, comprising:

a hollow cylinder of a fluid-permeable, resilient material, said cylinder having an outer surface, a central lumen, and proximal and distal ends, said cylinder defining proximal and distal openings of the central lumen, said cylinder being initially held in a compressed configuration by means of a sheath disposed thereabout, the permeable cylinder being formed of a material which is expandable when in contact with a bodily fluid;

a delivery device configured for introducing the compressed cylinder into the body lumen, said delivery device having a proximal end and a distal end, said compressed cylinder being carried by the delivery device adjacent the distal end of said delivery device, whereby the compressed cylinder may be advanced into a patient'"'"'s anatomy and placed adjacent to the target location;

means for breaking the seal and removing the sheath from about the cylinder, thereby allowing the cylinder to expand within the body cavity when it has been placed adjacent to the target location, so as to facilitate contact of the walls of the body cavity with the outer surface of said foam cylinder, and allowing the patient'"'"'s bodily fluids to flow through the body lumen past the cylinder via the central lumen of said cylinder;

means for providing a medicament to the form cylinder such that the medicament is placed in contact with said walls; and

means for inhibiting passage of the medicament into the lumen.

41. A method for facilitating selectively delivering a medicament to a target location of a wall of a body lumen, comprising the steps of:

a) providing an apparatus comprising;

a compressed hollow cylinder of permeable, expandable material, said cylinder having an outer surface, a central lumen, and proximal and distal ends defining openings in an expanded state, the cylinder being configured to facilitate fluid flow through the body lumen past the cylinder in an expanded state in a body lumen via the central lumen;

a delivery device configured for introducing the compressed cylinder into a patient'"'"'s body lumen, said delivery device having a proximal end and a distal end, said compressed cylinder being carried near the distal end of said delivery device, whereby the compressed cylinder may be placed adjacent to the target location;

means for expanding the cylinder within the body cavity when it has been placed adjacent to the target location so as to contact the walls of the body cavity with the outer surface of said foam cylinder, allowing the patient'"'"'s bodily fluids to freely flow through the central lumen of said cylinder;

means for perfusing said cylinder with a medicament comprising at least one hollow tube extending at least the length of the delivery device, said at least one tube having a first end which extends outside the patient and is configured to receive a medicament, and a second end adjacent the foam material, whereby medicament may be selectively introduced into said first end and thereby flow from said second end into the foam material, thereby placing the medicament in contact with said walls;

means for inhibiting the medicament from entering a flow of the patient'"'"'s bodily fluids in the body lumen;

b) introducing said apparatus into the anatomy of the patient;

c) directing said apparatus to an anatomical location in need of medicament;

d) expanding the cylinder within the patient so as to contact the walls of the body cavity with the outer surface of said foam cylinder, while allowing the patient'"'"'s bodily fluids to freely flow through the central lumen of said cylinder;

e) delivering a medicament to the target location by introducing the medicament into the first end of the hollow tube, such that the medicament flows out of the second end of said tube into the foam material, and is held in contact with the walls of the patient'"'"'s body cavity for sufficient time to be absorbed thereby.

42. The method of claim 41 further comprising the step of coating said cylinder with an anti-thrombogenic agent before introducing said apparatus into the anatomy of the patient.

43. The method of claim 41 wherein the step of expanding said cylinder within the patient further comprises the step of removing a sheath which surrounds the compressed cylinder, so as to allow the cylinder to expand within the patient'"'"'s anatomy.

44. The method of claim 41 wherein the step of expanding said cylinder within the patient further comprises the step of allowing the cylinder to swell when contacted by bodily fluids.

45. The method of claim 41 wherein the step of removing the apparatus from the patient'"'"'s anatomy following use further comprises retracting said cylinder into the lumen of a catheter having an openable mouth in the distal end thereof.

46. The method of claim 41 wherein the step of removing the apparatus from the patient'"'"'s anatomy following use further comprises capturing said apparatus with a capturing device disposed at the distal end of the delivery device.

47. A method of manufacturing an apparatus for selectively delivering a medicament to a target location of a wall of a patient'"'"'s body cavity, comprising the steps of:

a) forming a hollow cylinder of permeable, expandable foam, said cylinder having an outer surface, a central lumen, and proximal and distal ends;

b) forming an outer skin layer on at least the central lumen of said cylinder, configured for inhibiting the medicament from entering a flow of the patient'"'"'s bodily fluids in the body cavity;

c) attaching the cylinder to the distal end of a delivery device configured for introducing the compressed cylinder into the patient'"'"'s body lumen, said delivery device having a proximal end and a distal end, so that the foam cylinder may be advanced into a patient'"'"'s anatomy and placed adjacent to the target location by advancing the delivery device into the patient'"'"'s anatomy;

d) attaching to the cylinder a means for providing a medicament to the foam cylinder such that the medicament may be perfused into said foam material;

e) forming a sheath about the outer surface of said cylinder, whereby the foam cylinder is tightly compressed upon the distal end of said delivery device, and sealed from external contact; and

f) forming means for breaking the seal and removing the sheath from about the cylinder, thereby allowing the cylinder to expand within the body cavity so as to contact the walls of said cavity with the outer surface of said foam cylinder at the target location, allowing the medicament to be absorbed by the wall of the patient'"'"'s body cavity, while at the same time allowing the patient'"'"'s bodily fluids to freely flow through the central lumen of said cylinder.

48. The method of claim 47 wherein the step of forming a skin on at least the central lumen and end surfaces of said cylinder comprises the step of forming said cylinder by infecting foam into a mold such that the foam forms a skin on all surfaces in direct contact with the mold.

49. The method of claim 47 wherein the step of forming a skin on at least the central lumen and end surfaces of said cylinder comprises the steps of:

m) forming said cylinder by means of extruding a foam material with a skin on the inside surface of the central lumen; and

n) coating the end surfaces of the cylinder with a hydrophillic gel which occludes the foam cells when hydrated.

50. The method of claim 47 wherein the step of forming a skin on at least the central lumen and end surfaces of said cylinder comprises the steps of:

o) forming said cylinder by means of extruding a foam material with a skin on the inside surface of the central lumen; and

p) coating the end surfaces of the cylinder with material a form a skin.

51. The method of claim 47 wherein the step of forming a skin on at least the central lumen and end surfaces of said cylinder comprises the steps of:

q) forming a foam cylinder without a skin; and

r) bonding a skin onto the surface of said foam cylinder.

52. The method of claim 51 wherein the step of bonding a skin onto the surface of said foam cylinder comprises the step of dipping said cylinder so as to coat selected surfaces with a liquid material which cures and becomes a skin.

53. The method of claim 51 wherein the step of bonding a skin onto the surface of said foam cylinder comprises the step of dipping a cylindrically shaped skin material into a liquid foam material to thereby form the foam cylinder upon the preformed skin.

54. The method of claim 51 wherein the step of bonding a skin onto the surface of said foam cylinder comprises the step of spraying a skin forming material upon the surface of the cylinder.

55. The method of claim 54, further comprising the steps of:

s) inverting the foam cylinder before spraying the skin forming material thereon so as a expose the central lumen portion of the cylinder; and

t) re-inverting said cylinder following application of the skin so that the skin coated portion resumes its position as the surface of the central lumen of the cylinder.

56. The method of claim 47, further comprising the step of providing the ends of the cylinder with conical lips configured to facilitate a seal between the end surfaces of the foam cylinder and the body lumen.

57. The method of claim 47, further comprising the step of providing the ends of the cylinder with elastic lips so as to facilitate a seal between the end surfaces of the foam cylinder and the body lumen.

58. The method of claim 47, further comprising the step of providing the ends of the cylinder with a plurality of petal-shaped lips configured so as to facilitate a seal between the end surfaces of the foam cylinder and the body lumen.

59. The method of claim 47, further comprising the step of coating the ends of the foam cylinder with a hydrophillic gel which occludes the foam cells when hydrated so as to facilitate a seal between the end surfaces of the foam cylinder and the body cavity.