Infusion devices and method

• US 20020082546A1
• Filed: 12/21/2000
• Published: 06/27/2002
• Est. Priority Date: 12/21/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Mickley, Timothy J., Crank, Justin, Larson, Scott
• Granted Patent: US 6,616,626 B2
• Time in Patent Office: Days
• US Class Current: 604/48
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0085 Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0091 the single injection needle being fixed
• CPC Class Codes: A61M 2205/19 Constructional features of carpules, syringes or blisters
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

Devices and methods for performing improved percutaneous myocardial revascularization (PMR) procedures. One device includes a preassembled PMR drug delivery catheter and a drug neutralizing vial. The vial assembly allows prepping the PMR catheter by flushing drug through distal needle, and into a vial cavity where the drug is neutralized by a neutralizing agent. One set of devices includes needles having protrusions secured to the distal regions of drug delivery tubes. One needle has outward protruding barbs engaging the inner tube wall while another needle has outward threads which can screw into the tube inner wall. Radiopaque marker bands are also included in the present invention which are asymmetrically distributed on the catheter shaft, allowing a treating physician to determine under fluoroscopy whether the catheter distal region is pointed away or toward the treating physician, as well as determining whether the catheter distal region is rotated toward or away from the treating physician. PMR devices include catheters having dual injection needles, for both injecting a drug into the heart wall and a radiopaque contrast media to mark the already treated sites. One PMR injection device has multiple stops for allowing controlled, variable needle depth penetration with a single distal needle tip.

Claims

1. A myocardial revascularization preparation system comprising:

a myocardial revascularization drug delivery catheter including an elongate tube having a lumen and a distal portion, said distal portion having an injection device in fluid communication with said lumen; and

a drug receiving vial for receiving said catheter distal portion injection device, said vial including an inner cavity bordered at least in part by a gasket, said vial having a neck for receiving said myocardial revascularization drug delivery catheter distal portion.

2. A myocardial revascularization preparation system as in claim 1, wherein said vial cavity contains a drug neutralizing material.

3. A myocardial revascularization preparation system as in claim 2, wherein said gasket is formed of a self-sealing material.

4. A myocardial revascularization preparation system as in claim 2, wherein said vial neck includes a shoulder region for engaging said myocardial revascularization catheter distal portion.

5. A myocardial revascularization preparation system as in claim 4, wherein said myocardial revascularization catheter distal region has an expanded state and a non-expanded state, wherein said myocardial revascularization catheter distal region is sufficiently complaint to be pulled from said vial shoulder region while in said expanded state.

32. A myocardial revascularization catheter as in claim 1 wherein said outer shaft has at least two stops.

6. A drug neutralizing vial for preparing a drug delivery catheter, the drug delivery catheter including a distal portion having a distal injection device, the vial comprising:

a neck for receiving said drug delivery catheter distal injection device, said vial including an inner cavity therein and a gasket for sealing said cavity and for admitting said injection device therethrough, said vial cavity containing a drug neutralizing material.

7. A drug neutralizing vial as recited in claim 6, wherein said vial neck includes a shoulder region for engaging said drug delivery catheter distal portion.

8. A drug neutralizing vial as recited in claim 6, wherein said gasket is formed of a self-sealing material.

9. A method for preparing a drug delivery catheter for use, the drug delivery catheter including an elongate tube having a lumen and a distal portion, said distal portion having an injection device in fluid communication with said lumen, the method comprising the steps of:

providing a drug neutralizing vial for receiving said drug delivery catheter distal portion injection device, said vial including an inner cavity sealed at least in part by a gasket, said vial cavity containing a drug neutralizing material therein, said vial having a neck for receiving said drug delivery catheter distal portion;

inserting said drug delivery injection device through said gasket;

flushing at least some of said drug through said drug delivery injection device into said vial, such that said drug is at least partially neutralized in said cavity; and

withdrawing said drug delivery injection device from said gasket.

10. A drug delivery catheter comprising:

an elongate tube having a distal portion, a distal end, a tube wall, and a lumen therethrough; and

a needle having a lumen therethrough, a proximal portion, and a distal portion, said needle distal portion including a sharp distal end, said proximal portion being wider than said distal portion and having at least one protrusion for engaging said tube wall,

wherein said needle proximal portion engages said tube distal portion, wherein said needle distal portion extends distally beyond said tube distal end, such that said needle protrusions engage said tube wall to resist pulling said needle distally away from said tube.

11. A drug delivery catheter as in claim 10, wherein said tube has an inner wall surface, wherein said needle protrusions protrude outward and engage said tube inner wall surface.

12. A drug delivery catheter as in claim 10, wherein said at least one protrusion includes a plurality of barbs for engaging said tube wall.

13. A drug delivery catheter as in claim 12, wherein said barbs are inclined distally such that moving said needle distally is more difficult than moving said needle proximally.

14. A drug delivery catheter as in claim 10, wherein said needle includes a flange abutting said tube distal end for limiting proximal travel of said needle relative to said tube.

15. A drug delivery catheter as in claim 10, wherein said tube wall distal region includes a hole therethrough for receiving a bonding material, wherein said needle is further secured to said tube by said bonding material being injected through said hole.

16. A drug delivery catheter as in claim 10, wherein said at least one protrusion includes at least one helical thread for engaging said tube wall.

17. A drug delivery catheter as in claim 10, wherein said at least one protrusion includes a plurality of threads for engaging said tube wall.

18. A drug delivery catheter as in claim 10, wherein said needle is disposed within said tube lumen, said needle includes a lumen therethrough, and said lumen has a proximal throat region.

20. A catheter as in claim 19, wherein said marker is asymmetric with respect to a transverse bisecting plane through said shaft and marker.

21. A catheter as in claim 19, wherein said marker includes more than one region, and said regions are contiguous with each other.

22. A catheter as in claim 19, wherein said marker includes a first portion transverse to said central longitudinal axis and a second portion parallel to said longitudinal axis.

23. A catheter as in claim 19, wherein said marker includes more than one region, and said regions are not all contiguous with each other.

24. A catheter as in claim 19, wherein said radiopaque marker includes a first arcuate portion disposed about said shaft and a second linear portion disposed along said shaft and substantially parallel to said shaft longitudinal axis.

25. A catheter as in claim 24, wherein said first arcuate portion includes an annular portion about said shaft and contiguous with said second marker portion.

26. A catheter as in claim 19, wherein said marker includes a first portion extending along said shaft length parallel to said central longitudinal axis and a second portion extending transversely to said shaft central axis.

27. A catheter as in claim 26, wherein said shaft has a length and a circumference, wherein said marker first portion includes an arcuate shell extending along said shaft length in an annular fashion around less than all of said shaft circumference, wherein said second marker portion is an annular band extending transversely to said central axis.

28. A catheter as in claim 19, wherein said first marker portion includes a first arcuate shell on one side of said bisection plane, wherein said second marker portion includes a second arcuate shell disposed on the other side of said bisection plane relative to said first arcuate shell, wherein said first and second arcuate shells are disposed over different lengths on said shaft.

29. A catheter as in claim 28, wherein said catheter shaft has a bend, and said marker is disposed proximal of said bend.

30. A catheter as in claim 28, wherein said arcuate shells are substantially annular.

19. A catheter comprising:

an elongate shaft having a central longitudinal axis, a radial dimension extending outward from said central axis, and a distal region, wherein a plane bisecting said shaft through said longitudinal axis defines a shaft first portion and a shaft second portion opposite said shaft first portion; and

a radiopaque marker disposed in said shaft distal region, wherein said radiopaque marker is asymmetric about said bisecting plane, such that said catheter distal portion appears differently under fluoroscopy when viewed from an angle less than ninety degrees (90°

) to said plane than when viewed from an angle greater than ninety degrees (90°

) to said plane.

31. A myocardial revascularization catheter comprising:

an outer shaft having a lumen therethrough and a distal end;

an inner shaft for drug delivery having a distal end, and being slidably and rotatably disposed with said outer shaft;

at least one inner stop outwardly disposed on said inner shaft, said outer stop occupying less than 360°

degrees of arc;

at least one outer stop fixedly disposed in said outer shaft lumen, said outer stop occupying less than 360°

degrees of arc;

said inner and outer stops being cooperatively sized such that said inner and outer stops abut each other in a first rotational configuration, but allow axial passage past each other in a second rotational configuration, such that said inner shaft distal end extends a maximum first distance past said outer shaft distal end in said first rotational configuration, and said inner shaft distal end extends a maximum second distance past said outer shaft distal end in said second rotational configuration, said second distance being greater than said first distance, allowing said inner shaft distal end to penetrate a greater distance in said myocardium into said second rotational configuration.

33. A myocardial revascularization catheter having a proximal region and a distal region comprising:

an outer tube having an outer lumen therethrough; and

an inner tube disposed in said outer lumen;

said inner tube having a first lumen therethrough having a first proximal port, a first lumen distal region, and a first lumen distal injection port; and

said inner tube having a second lumen therethrough having a second proximal port, a second lumen distal region, and a second lumen distal injection port.

34. A myocardial revascularization catheter as in claim 33, wherein said outer tube has a distal atraumatic flange.

35. A myocardial revascularization catheter as in claim 33, wherein said inner tube is slidably disposed within said outer tube.

36. A myocardial revascularization catheter as in claim 35, wherein said first lumen is defined within a first tube and said second lumen is defined within a second tube, wherein said inner tube includes said first and second tubes being operably coupled together.

37. A myocardial revascularization catheter as in claim 33, wherein said first lumen distal region is disposed within a first injection tube and said first injection tube is arcuate.

38. A myocardial revascularization catheter as in claim 33, wherein said second lumen distal region is disposed within a second injection tube and said second injection tube is arcuate.

39. A myocardial revascularization catheter as in claim 33, wherein said first lumen distal region is disposed within a first injection tube and said second lumen distal region is disposed within a second injection tube.

40. A myocardial revascularization catheter as in claim 37, wherein said first injection tube terminates in a sharp distal tip for penetrating into said myocardium.

41. A myocardial revascularization catheter as in claim 37, wherein said first injection tube terminates in a dull distal tip for forcing a fluid under pressure into said myocardium.

42. A myocardial revascularization catheter as in claim 39, wherein said first injection and second injection tubes are retractable into said outer tube distal end.

43. A myocardial revascularization catheter as in claim 33, wherein said first and second lumens are disposed in a side by side configuration.

44. A myocardial revascularization catheter as in claim 33, wherein said first and second lumens are disposed in a coaxial configuration.

45. A myocardial revascularization catheter as in claim 33, wherein said first and second lumens are disposed within tubes disposed in a coaxial configuration.

48. A method for performing myocardial revascularization as in claim 47, wherein said contrast medium in injected contemporaneously with said therapeutic substance injection.

49. A method for performing myocardial revascularization as in claim 47, wherein said contrast medium in injected substantially concentrically about said therapeutic substance injection location.

46. A method for performing myocardial revascularization, the method comprising the steps of:

providing a myocardial revascularization catheter having a proximal region and a distal region, the catheter including,

an outer tube having an outer lumen therethrough, and

an inner tube disposed within said outer lumen,

said inner tube including a first lumen therethrough having a first proximal port, a first distal region, and a first lumen distal injection port, and

said inner tube including a second lumen therethrough having a second proximal port, a second lumen distal region, and a second lumen distal injection port;

providing a therapeutic substance;

providing a radiopaque contrast media;

injecting said therapeutic substance through said first lumen into said myocardium; and

injecting said contrast media through said second lumen into said myocardium near said injected therapeutic substance, such that said therapeutic substance injection location is radiopaquely marked.

47. A method for performing myocardial revascularization, the method comprising:

injecting a therapeutic substance for promoting revascularization into said myocardium at a first location; and

injection a radiopaque contrast medium into said myocardium near said first location to mark said first location radioscopically.

50. A method for performing myocardial revascularization, the method comprising the steps of:

providing a myocardial revascularization catheter including a distal region having at least two radiopaque markers disposed a distance apart, and having a distal therapeutic treatment tip;

treating a first site in said myocardium using said revascularization catheter;

moving said distal therapeutic treatment tip away from said first site by about said distance to a second site; and

treating said second site in said myocardium.

51. A method as recited in claim 50, wherein said treating and moving steps are performed under fluoroscopy.