Steerable unitary infusion catheter/guide wire incorporating detachable infusion port assembly

• US 6,059,767 A
• Filed: 02/25/1998
• Issued: 05/09/2000
• Est. Priority Date: 02/25/1998
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Norborn Medical, Inc. (Boston Scientific Corporation)
• Inventors: Noriega, Gerardo V.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US09/030,657
• Time in Patent Office: 804 Days
• Field of Search: 604/264, 604/95, 604/525, 604/528, 604/523, 604/532-535, 604/500, 604/502, 604/506, 604/507, 604/508, 604/513, 128/772
• US Class Current: 604/523
• CPC Class Codes: A61M 2025/091 having a lumen for drug delivery or suction
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

Medical guidewires and catheters include tubular bodies having coils at their distal ends to permit steering through the vasculature. The guidewires and catheters are useful for delivering fluids to a target site, draining body fluids from a target site, and are particularly useful for the infusion of medicaments to sites within the body.

Claims

1. A steerable infusion catheter/guide wire, comprising:

a) an elongated cannula symmetrical about a longitudinal axis and having open proximal and distal end portions;

b) an infusion port assembly symmetrical about said longitudinal axis and sealingly secured detachably to said proximal end portion of said cannula and digitally rotatable to correspondingly rotate said elongated cannula over its entire length; and

c) a flexible distal segment including means interrelated to provide an elongated bendable tubular member generally symmetrical about said longitudinal axis and having an open proximal end portion and an open distal end portion, said open proximal end portion having its open proximal end concentrically secured within the open distal end portion of said elongated cannula.

2. The steerable infusion catheter/guide wire according to claim 1, wherein said elongated cannula is metallic.

3. The steerable infusion catheter/guide were according to claim 1, wherein said elongated cannula is fabricated from an alloy of nickel and titanium.

4. The steerable infusion catheter/guide wire according to claim 1, wherein said elongated cannula possesses a uniform diameter over its entire length.

5. The steerable Infusion catheter/guide wire according to claim 1, wherein said cannula has an outer diameter of approximately 0.018".

6. The steerable infusion catheter/guide wire according to claim 1, wherein said catheter is approximately 175 centimeters in overall length.

7. The steerable infusion catheter/guide wire according to claim 1, wherein said cannula is approximately 155 centimeters in overall length.

8. The steerable infusion catheter/guide wire according to claim 1, wherein said flexible distal segment extends approximately 20 centimeters from the open distal end portion of said cannula.

9. The steerable infusion catheter/guide wire according to claim 1, wherein said open distal end portion of said flexible distal segment comprises radio-opaque material.

10. The steerable infusion catheter/guide wire according to claim 1, wherein said open proximal end portion of said flexible distal segment comprises a stainless steel coil a plurality of the proximal turns of which are spaced apart and concentrically secured within the open distal end portion of said elongated cannula.

11. The steerable infusion catheter/guide wire according to claim 1, wherein said open proximal end portion of said flexible distal segment comprises a stainless steel coil and said open distal end portion of said flexible distal segment comprises a radio-opaque coil both symmetrical about said longitudinal axis.

12. The steerable infusion catheter/guide wire according to claim 1, wherein said means of said flexible distal segment interrelated to provide a bendable tubular member includes an elongated non-metallic flexible inner tube the proximal open end portion of which is sealingly attached to the inner periphery of said distal end portion of the cannula.

13. The steerable infusion catheter/guide wire according to claim 1, wherein said means of said flexible distal segment interrelated to provide a bendable tubular member includes an elongated bendable metallic strap parallel to said longitudinal axis and laterally spaced therefrom.

14. The steerable infusion catheter/guide wire according to claim 1, wherein said means of said flexible distal segment interrelated to provide a bendable tubular member includes an elongated non-metallic flexible outer tube the proximal end portion of which is sealingly attached concentrically about the distal end portion of said cannula and the distal end portion of which outer tube is sealingly attached concentrically about the open distal end portion of said flexible distal segment.

15. The steerable Infusion catheter/guide wire according to claim 11, wherein said stainless steel and radio-opaque coils include coil turns that are axially aligned and at least one of the distal end turns of said stainless steel coil is intertwined with and attached to the associated proximal end turns of the radio-opaque coil.

16. The steerable infusion catheter/guide wire according to claim 15, wherein a plurality of the proximal turns of said stainless steel coil are spaced apart and concentrically secured within the open distal end portion of said elongated cannula, an elongated non-metallic flexible inner tube disposed concentrically within and spanning the length of said stainless steel and radio-opaque coils, a proximal end portion of said inner tube sealingly attached to said spaced stainless steel coil turns and to the inner periphery of said distal end portion of said elongated cannula and a distal end portion of said inner tube projecting out of the open distal end of said radio-opaque coil, an elongated bendable metallic strip parallel to said longitudinal axis and interposed between the outer periphery of said inner tube and the inner peripheries of said stainless steel and radio-opaque coils, the proximal and distal end portions of said metallic strip being attached to corresponding associated end portions of said coils and an intermediate portion of said bendable metal strip being attached to said intertwined turns of said coils, and an elongated non-metallic flexible outer tube concentrically surrounding and sealingly attached to the distal end portion of said elongated cannula, said intertwined axially aligned coils and said projecting distal end portion of said inner tube, whereby said outer tube forms a flexible outer lumen for said flexible distal segment.

17. The steerable infusion catheter/guide wire according to claim 16, wherein a plurality of radially extending apertures are formed in said Inner and outer tubes through which a liquid or liquid-like substance may be radially dispensed under pressure into a target tissue site.

18. The steerable infusion catheter/guide wire according to claim 16, wherein said distal end portion of said cannula, said aligned coils and said bendable elongated metallic strip are sealingly encapsulated between said flexible non-metallic inner and outer tubes.

19. The steerable infusion catheter/guide wire according to claim 12, wherein said non-metallic flexible inner tube is formed from a synthetic resinous material.

20. The steerable Infusion catheter/guide wire according to claim 14, wherein said non-metallic flexible outer tube is formed from a heat-shrinkable synthetic resinous material.

21. The steerable infusion catheter/guide wire according to claim 15, wherein said intertwined turns of said proximal and distal coils are soldered to one another.

22. The steerable infusion catheter/guide wire according to claim 13, wherein said elongated bendable metallic strip is formed from stainless steel.

23. The steerable infusion catheter/guide wire according to claim 1, wherein said infusion port assembly includes a gland having a tubular cylindrical wall having attachment means on its inner periphery and generally open at one end and closed at its opposite end by a transverse end wall having proximal and distal faces and having a central bore extending therethrough symmetrical about said longitudinal axis and intercepted by said proximal and distal faces, and an infusion port fitting selectively attachable to said tubular cylindrical wall and adjustable axially in relation to said gland.

24. The steerable infusion catheter/guide wire according to claim 23, wherein said central bore in said transverse end wall is chamferred at said distal face to facilitate the entry and passage of the proximal end portion of said elongated cannula into said central bore and through said transverse end wall.

25. The steerable infusion catheter/guide wire according to claim 23, wherein said attachment means on the inner periphery of said tubular cylindrical wall comprise screw threads concentric to said longitudinal axis.

26. The steerable infusion catheter/guide wire according to claim 23, wherein said proximal face of said transverse wall intercepts the periphery of said central bore at an angle of 90 degrees.

27. The steerable infusion catheter/guide wire according to claim 23, wherein said infusion port fitting includes a central bore symmetrical about said longitudinal axis and through which said cannula projects, means on said infusion port fitting cooperating with said attachment means on said gland enabling selective relative axial displacement of said gland and said infusion sort fitting, and seal means surrounding said proximal end portion of said cannula disposed within said infusion port assembly and interposed between said gland and said infusion port fitting and elastically compressible to resiliently engage said proximal end portion of said cannula when said gland and said infusion port fitting are displaced toward one another sufficiently to compress said seal means, whereby rotation of said infusion port assembly effects a corresponding rotation of said elongated cannula and said flexible distal segment of said catheter.

28. The steerable infusion catheter/guide wire according to claim 27, wherein said infusion port fitting is provided with a distal end surface having a conical recess surrounding said proximal portion of said cannula, and said seal means is mounted in said conical recess.

29. The steerable infusion catheter/guide wire according to claim 28, wherein said seal means comprises an "O"-ring having an outer peripheral diameter approximately equal to the base diameter of said conical recess and an inner peripheral diameter closely surrounding said cannula, whereby when said "O"-ring is compressed into said conical recess by said gland both said outer and inner peripheral diameters of said "O" ring are reduced, so that said inner periphery of said "O"-ring resiliently and nonrotatably engages the outer periphery of the associated cannula whereby the entire length of said cannula and said flexible distal segment may selectively be rotated by rotation of said gland.

30. The steerable infusion catheter/guide wire according to claim 29, wherein said attachment means on said gland comprises screw threads formed on the inner periphery of said tubular cylindrical wall, and said infusion port fitting is provided with corresponding screw threads engageable therewith whereby relative rotation of said gland and said infusion port fitting effects selective relative axial displacement thereof toward or away from one another.

31. As an article of manufacture, a three-part assembly for use with elongated cylindrical members such as rods or tubes enabling slidably mounting said three-part assembly in assembled form onto said cylindrical member and thereafter selectively locking said three-part assembly immovably to said cylindrical member, comprising:

a) a gland symmetrical about a longitudinal axis and including a tubular cylindrical wall member having screw threads on its inner periphery and a transverse end wall closing one end of said tubular cylindrical member and having a bore therethrough concentric to said longitudinal axis for slidably receiving therethrough said rod or tube;

b) a cylindrical fitting symmetrical about said longitudinal axis and having a tubular member having screw threads on its outer periphery selectively engageable with said screw threads on said gland and a distal end wall having a central bore therethrough and a distal end surface having a conical recess therein communicating at its apex end with said central bore; and

c) seal means having a compressible body mounted in said conical recess so that a portion of said compressible body projects out of the base of said conical recess and having a central aperture therethrough having a diameter at least as large as the diameter of said central bore, whereby when said gland and said cylindrical fitting are rotated to advance said fitting into said gland said seal means is compressed and the diameter of said aperture through said compressible body is reduced whereby a rod or tube projecting through said aperture is resiliently impinged sealingly by said seal means, whereby said three-part assembly is locked onto a red or tube extending through said assembly.

32. The article of manufacture according to claim 31, wherein said seal means comprises an "O"-ring the outer peripheral diameter of which is approximately equal to the base diameter of said conical recess and the inner peripheral diameter is at least as large as said central bore in said distal end wall.

33. The article of manufacture according to claim 32, wherein said transverse end wall of said gland has a proximal face confronting said distal end surface of said distal end wall of said cylindrical fitting, said bores in said end walls are axially aligned, and said "O"-ring is compressed into said conical recess by the confronting proximal face of said transverse end wall of said gland when said distal end surface of said distal end wall of said cylindrical fitting abuts said confronting proximal face of said transverse wall, whereby the inner peripheral diameter of said aperture through said "O"-ring is constricted to less than the diameter of the associated bore in the absence of a rod or tube in said bore.

34. The article of manufacture according to claim 31, wherein the outer peripheral surface of said tubular cylindrical wall member is knurled.

35. The article of manufacture according to claim 31, wherein said tubular member of said cylindrical fitting constitutes the distal portion of said fitting, a radially outwardly extending flange integral with the proximal end of said tubular member, a proximal tubular portion axially aligned with said distal portion and integral with said radially outwardly extending flange, and an asymmetric radially outwardly extending lock flange integral with the proximal end of said proximal tubular portion.