Valvulotome with leaflet disruption heads and fluid supply

• US 4,952,215 A
• Filed: 02/29/1988
• Issued: 08/28/1990
• Est. Priority Date: 02/29/1988
• Status: Expired due to Fees

• Current Assignee: Biosurge Incorporated
• Original Assignee: Boisurge Incorporated
• Inventors: Lamond, Donald, Ouriel, Kenneth, Kirk, Karl D.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/161,817
• Time in Patent Office: 911 Days
• Field of Search: 128/305, 128/303 R, 128/311, 128/313, 128/309, 128/306, 128/751, 604/22, 604/159, 604/170, 604/191
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 2017/22097 Valve removal in veins

Abstract

A valvulotome for rendering venous valve leaflets incompetent includes a rigid support comprising a fluid supply tube and, molded thereon, a dilator, and first and second valve disrupting heads. Each of the disrupting heads has a plane of symmetry, wherein the planes of symmetry of the two disrupting heads are relatively rotated by about 90°. A fluid emitting end of the fluid supply tube communicates with an irrigation port in a disrupting head so that fluid emitted through the irrigation port, during use, applies pressure to the valve leaflets to be disrupted. The other end of the fluid supply tube is swaged onto a catheter which in turn is coupled to a fluid supply source for the purpose of supplying fluid to the irrigation port.

Claims

1. A valvulotome for rendering various valve leaflets incompetent comprising:

a rigid support

a first disrupting head mounted on said support with a disrupting surface mounted for disrupting action during retrograde motion of said valvulotome,

said rigid support comprising a fluid supply tube having a fluid outlet, said fluid supply tube extending into said disrupting head so that said fluid outlet supplied fluid to a location during a retrograde motion with respect to the direction of blood flow after said disrupting head has initially passed said location; and

a second disrupting head located on said support and positioned ahead of said first disrupting head during said retrograde motion.

2. A valvulotome as recited in claim 1 which further includes a dilator mounted on said support and positioned ahead of said first disrupting head during said retrograde motion.

3. A valvulotome as recited in claim 2 wherein said fluid supply tube extends trough said second disrupting head, said dilator and into said first disrupting head.

4. A valvulotome as recited in claim 1 wherein said fluid supply tube includes a flanged end and a catheter coupled to said flanged end.

5. A valvulotome comprising a cannula having a first flanged end and a second flanged end, said cannula including at least three spaced regions, each of said regions including machined surface discontinuities, two of said three spaced regions located adjacent a different one of said flanged ends,

a first valve leaflet disrupting head integrally mounted on said cannula and encompassing one of said surface discontinuity including regions adjacent said first flanged end, said valve disrupting head including first and second ends, a first end including an irrigation port communicating with said flanged end of said cannula, and a second end, opposite said first end, including a valve leaflet disrupting surface,

a second valve disrupting head integrally supported on said cannula superimposed on that one of said surface discontinuity including regions not adjacent either of said flanged ends, said second valve leaflet disrupting head including a first, streamlined end and a second, valve leaflet disrupting end, opposite said first end,

a vein dilator integrally supported on said cannula adjacent one of said surface discontinuity including regions adjacent said second flanged end and extending beyond said second flanged end, said dilator including a first streamlined end and a second streamlined end,

a catheter with a first end swaged onto said second flanged end of said cannula and located within said vein dilator, and a fluid coupling located on another end of said catheter.

6. The valvulotome of claim 5 wherein said first and second valve disrupting heads have planes of symmetry, a plane of symmetry of a first valve disrupting head rotated about 90°

with respect to a plane of symmetry of said second valve disrupting head.

7. A method of manufacturing a valvulotome comprising the steps of:

(a) providing a hollow cannula,

(b) attaching said cannula to a catheter,

(c) molding onto said hollow cannula at least two bodies, a first body comprising a valve disrupting head with at least one disrupting element and a fluid outlet communicating with a fluid outlet of said hollow cannula, and a second body comprising a dilator, said second body spaced from said first body along said cannula; and

(d) molding a third body onto said hollow cannula located between said first body and said second body, said third body comprising another valve disrupting head with a valve disrupting element.

8. A method as recited in claim 7 which includes a step of providing said catheter with a free end having a fluid coupling.

9. A method as recited in claim 7 wherein prior to said step (c) an outer surface of said cannula is distorted.

10. A method as recited in claim 9 wherein said surface distortion is effected at least at one location encompassed by each of said bodies.

11. A valvulotome for rendering venous valve leaflets incompetent comprising:

a rigid support,

a first disrupting head mounted on said support with a disrupting surface mounted for disrupting action during a retrograde motion, with respect to the direction of blood flow, of said valvulotome,

a dilator mounted on said support and positioned ahead of said first disrupting head during said retrograde motion,

a second disrupting head located on said support and positioned between said first disrupting head and said dilator,

said rigid support comprising a fluid supply tube having a fluid outlet, said fluid supply tube extending through said second disrupting head, said dilator, and into said first disrupting head so that said fluid outlet supplies fluid to a location during said retrograde motion after said first and second disrupting heads have initially passed said location,

said first and second disrupting heads each having an axis of symmetry wherein said axis of symmetry of said first disrupting head is rotated relative to said axis of said second disrupting head by about 90 degrees.

12. A valvulotome for rendering venous valve leaflets incompetent comprising:

a rigid support,

a first disrupting head mounted on said support with a disrupting surface mounted for disrupting action during a retrograde motion, with respect to the direction of blood flow, of said valvulotome,

said rigid support comprising a fluid supply tube having a fluid outlet, said fluid supply tube extending into said first disrupting head so that said fluid outlet supplies fluid to a location during said retrograde motion after said disrupting head has initially passed said location,

said fluid supply tube further including a flanged end and a catheter coupled to said flanged end,

said first disrupting head being integrally mounted on said fluid supply tube,

a second disrupting head integrally mounted on said fluid supply tube and positioned ahead of said first disrupting head during said retrograde motion,

a dilator mounted on said fluid supply tube and positioned ahead of said first disrupting head during said retrograde motion,

wherein said first and second disrupting heads each having an axis of symmetry wherein said axis of symmetry of said first disrupting head is rotated relative to said axis of said second disrupting head by about 90 degrees.

13. A valvulotome for rendering venous valve leaflets incompetent comprising:

a rigid support,

a first disrupting head mounted on said support with a disrupting surface mounted for disrupting action during retrograde motion, with respect to the direction of blood flow, of said valvulotome,

said rigid support comprising a fluid supply tube having a fluid outlet, said fluid supply tube extending into said first disrupting head so that said fluid outlet supplies fluid to a location during said retrograde motion after said disrupting head has initially passed said location,

said fluid supply tube further including a flanged end and a catheter coupled to said flanged end,

said first disrupting head being integrally mounted on said fluid supply tube,

a second disrupting head integrally mounted on said fluid supply tube and positioned ahead of said first disrupting head during said retrograde, motion,

a dilator mounted on said fluid supply tube and positioned ahead of said first disrupting head during said retrograde motion,

said first and second disrupting heads each having an axis of symmetry wherein said axis of symmetry of said first disrupting head is rotated relative to said axis of said second disrupting head by about 90 degrees,

and wherein said fluid supply tube is circumferentially knurled at one or more locations which are encompassed by said first and said second disrupting heads and said dilator.

14. A method of manufacturing a valvulotome for rendering venous valve leaflets incompetent comprising the steps of:

(a) providing a hollow cannula,

(b) attaching said cannula to a catheter,

(c) molding onto said hollow cannula three bodies;

a first body comprising a valve disrupting head with at least one disrupting element and a fluid outlet communicating with a fluid outlet of said hollow cannula;

a second body comprising a dilator, said second body spaced from said first body along said cannula; and

a third body located between said first body and said second body, said third body comprising another valve disrupting head with a valve disrupting element, and

said first and third bodies being molded onto said hollow cannula so that each includes an axis of symmetry wherein said axis of symmetry of one of the disrupting heads of said first or third bodies is rotated, relative to an axis of symmetry of the other disrupting head of said first or third bodies, by about 90 degrees.

15. A method of manufacturing a valvulotome for rendering venous valve leaflets incompetent comprising the steps of:

(a) providing a hollow cannula,

(b) attaching said cannula to a catheter,

(c) distorting an outer surface of said cannula at least at one location encompassed by each of said bodies,

(d) molding onto said hollow cannula three bodies,

a first body comprising a valve disrupting head with at least one disrupting element and a fluid outlet communicating with a fluid outlet of said hollow cannula;

a second body comprising a dilator, said second body spaced from said first body along said cannula;

a third body located between said first and second body, said third body comprising another valve disrupting head with a valve disrupting element and wherein said surface distortion is effected at a location encompassed by said third body.