Dilatation catheter

• US 5,954,742 A
• Filed: 03/14/1997
• Issued: 09/21/1999
• Est. Priority Date: 03/16/1996
• Status: Expired due to Term

• Current Assignee: Peter Osypka
• Original Assignee: Peter Osypka
• Inventors: Osypka, Peter
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): NGO, LIEN M
• Application Number:
  US08/818,574
• Time in Patent Office: 921 Days
• Field of Search: 606/198, 606/194, 606/63, 606/191-192, 606/127, 606/201, 606/200, 604/48, 607/105, 607/122, 600/201, 600/204
• US Class Current: 606/198
• 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 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A balloon-free dilatation catheter has an elongated flexible sheath which is insertable into an animal body so that its distal end is located at or within a selected portion of an internal passage, such as in a blood vessel. The distal end normally confines an elongated cage-like expander having elongated at least partially resilient expanding elements which store energy when confined within the distal end but expand and bear against the tissue surrounding the selected portion of the internal passage when expelled from the distal end by one or more sleeve-like displacing elements confined in and movable circumferentially and/or longitudinally of the sheath. The expanding elements can carry one or more thermometers and/or the discharge end(s) of one or more conduits for a medication or another flowable substance and/or they can be connected to an energy source, e.g., to cool or heat and/or otherwise treat the tissue. The cage is configurated to effect a predictable expansion of a selected portion of an internal passage when it is expelled beyond the distal end of the sheath.

Claims

1. A catheter for the treatment of tissue surrounding a passage in a portion of an animal body, comprising an elongated tubular sheath having a distal end adapted to be introduced into a selected portion of a passage;

an expander including a plurality of at least partially resilient expanding elements together defining a cage contractible and expandible radially of said tubular sheath and having a contracted condition within and a radially expanded condition outside of the distal end of said sheath, said elements having spaced-apart distal and proximal terminals and elongated intermediate sections between the respective distal and proximal terminals said intermediate sections being at least substantially parallel to each other in said contracted as well as in said radially expanded condition of said cage, said elements being maintained in a stressed condition when located within said sheath and tending to expand radially outwardly beyond said distal end and to bear upon the tissue surrounding the selected portion of a passage when at least said intermediate section and said distal terminals are located outside of said distal end; and

means for moving said elements within, beyond and back into the distal end of said sheath.

2. The catheter of claim 1, wherein said proximal and distal terminals respectively define first and second annular sections having at least substantially unchanging diameters, that portion of said cage which includes said intermediate sections having a diameter which exceeds said substantially unchanging diameters when said intermediate sections are located outside of said sheath, as a result of movement of said distal terminals and said intermediate sections beyond said distal end, to an extent determined by the extent of stress upon said elements when said intermediate sections are located within said sheath and upon the resistance offered by the tissue surrounding the selected portion of a passage when at least said distal terminal sand said intermediate sections are located outside and at the distal end of said sheath.

3. The catheter of claim 1, wherein each of said intermediate sections includes at least one wire-like filament.

4. The catheter of claim 3, wherein said intermediate sections are at least substantially straight and together constitute an elongated substantially tubular portion of said cage.

5. The catheter of claim 4, wherein said tubular portion of said cage at least resembles a hollow cylinder, at least when said intermediate sections and said distal terminals are located outside of said distal end.

6. The catheter of claim 1 wherein, at least when located outside of said distal end, said intermediate sections together form an elongated hollow cylindrical envelope having a longitudinal axis and a plurality of at least substantially straight wire-like components at least substantially parallel to said axis.

7. The catheter of claim 1, wherein said expander further includes a tubular follower connected with and extending beyond said distal terminals of said expanding elements away from said intermediate sections.

8. The catheter of claim 7, further comprising an elongated flexible guide surrounded by said sheath and said follower and having normally exposed proximal and distal end portions respectively adjacent said proximal end of said sheath and said follower.

9. The catheter of claim 1, wherein said moving means includes an elongated tube having a distal portion associated with the proximal terminals of said expanding elements and extending within an annulus defined by said proximal terminals toward said proximal end of said sheath.

10. The catheter of claim 9, wherein said tube contains a metallic material.

11. The catheter of claim 9, wherein said distal portion of said tube is secured to and maintains said proximal terminals in mutual positions such that said proximal terminals together form an annulus adjacent said intermediate sections.

12. The catheter of claim 11, wherein said distal portion of said tube is bonded to said proximal terminals.

13. The catheter of claim 9, wherein said distal portion of said tube has an external surface surrounded by the proximal terminals of said expanding elements.

14. The catheter of claim 1, wherein said tube has a proximal end portion extending beyond said proximal terminals toward said proximal end of said sheath and affixed to said displacing member.

15. The catheter of claim 1, wherein said moving means comprises an elongated displacing member disposed within said sheath and having a distal end portion at least indirectly affixed to the proximal terminals of said expanding elements.

16. The catheter of claim 15, wherein said displacing member is designed to push and pull said proximal terminals relative to said sheath.

17. The catheter of claim 15, wherein said moving means further comprises a handgrip portion affixed to a proximal end portion of said displacing member and accessible at the proximal end of said sheath to facilitate a longitudinal shifting of said displacing member and said proximal terminals relative to said sheath.

18. The catheter of claim 17, wherein said displacing member and said handgrip portion together constitute a means for imparting to said proximal terminals at least one of a plurality of movements including longitudinally and circumferentially of said sheath.

19. The catheter of claim 1, wherein said moving means comprises a first substantially sleeve-like displacing member disposed within said sheath and at least indirectly connected with the proximal terminals of said expanding elements, and a second substantially sleeve-like displacing member disposed within said sheath and at least indirectly connected with the proximal terminals of said expanding elements.

20. The catheter of claim 19, wherein one of said displacing members is surrounded by the other of said displacing members, said displacing members being jointly movable relative to said sheath at least in one of a plurality of different directions including longitudinally and circumferentially of said sheath.

21. The catheter of claim 19, wherein said moving means further comprises at least one handgrip member accessible at the proximal end of said sheath and connected to at least one of said displacing members.

22. The catheter of claim 21, wherein said at least one handgrip member is affixed to each of said displacing members and is movable relative to said proximal end at least in one of a plurality of directions including longitudinally and circumferentially of said sheath.

23. The catheter of claim 1, wherein said expander further comprises a tubular follower affixed to the distal terminals of said expanding elements and extending away from said intermediate sections, said moving means comprising at least one substantially sleeve-like displacing member affixed to at least one of said distal and proximal terminals, and further comprising an elongated flexible guide extending through said follower and said at least one displacing member, said guide on the one hand and said at least one displacing member and said follower on the other hand being movable relative to each other in at least one of the directions longitudinally and circumferentially of said sheath.

24. The catheter of claim 1, wherein said expander includes an array of between four and ten expanding elements.

25. The catheter of claim 1, wherein said expander comprises an array of six expanding elements.

26. The catheter of claim 1, wherein said expander comprises an array of between three and ten elongated expanding elements which are at least substantially equidistant from each other in a circumferential direction of said sheath.

27. The catheter of claim 1, further comprising a thermometer associated with at least one of said expanding elements.

28. The catheter of claim 27, wherein said thermometer is adjacent the intermediate section of the respective expanding element.

29. The catheter of claim 1, further comprising an energy source and means for connecting said source with at least one of said expanding elements.

30. The catheter of claim 29, wherein said source is a source of high-frequency energy and said means for connecting comprises a tubular conductor connected to at least some of said expanding elements.

31. The catheter of claim 1, further comprising a thermometer affixed to each of said expanding elements.

32. The catheter of claim 1 further comprising thermomemters connected to at least some of said expanding elements, said thermometers being staggered in the longitudinal direction of said sheath.

33. The catheter of claim 1, further comprising a thermometer disposed at least at one of said expanding elements, a source of energy, at least one first conductor arranged to connect said source with at least one of said expanding elements, and at least one second conductor connected with said thermometer, said moving means comprising first and second substantially sleeve-like displacing members affixed to the proximal terminals of said expanding elements and one of said displacing members being surrounded by the other of said displacing members, at least one of said conductors being located between said displacing members and extending from said expander toward said proximal end of said sheath.

34. The catheter of claim 1, wherein said distal terminals are disposed at least close to a first plane and said proximal terminals are disposed at least close to a second plane, at least one of said planes extending transversely of said sheath.

35. The catheter of claim 34, wherein said at least one plane is at least substantially normal to a longitudinal axis of said sheath.

36. The catheter of claim 34, wherein said at least one plane makes an oblique angle with a longitudinal axis of said sheath.

37. The catheter of claim 1, further comprising means for conveying a flowable substance from said proximal end of said sheath, within said sheath and to at least one of said expanding elements.

38. The catheter of claim 37, wherein said conveying means includes a portion forming part of said at least one expanding element.

39. The catheter of claim 37, wherein said at least one expanding element is a conduit for the flowable substance.

40. The catheter of claim 39, wherein said conduit has at least one outlet for flowable substance.

41. The catheter of claim 40, wherein said at least one outlet is arranged to discharge flowable substance substantially radially of and away from an elongated axis of said cage.

42. The catheter of claim 37, wherein said conveying means includes a conduit surrounding said at least one expanding element.

43. The catheter of claim 42, wherein said conduit has a discharge end for flowable substance at the intermediate section of the respective expanding element.