Device and method for external correction of insufficient valves in venous junctions

• US 5,476,471 A
• Filed: 04/15/1994
• Issued: 12/19/1995
• Est. Priority Date: 08/19/1993
• Status: Expired due to Term

• Current Assignee: Mind - EMSG Limited
• Original Assignee: Mind - EMSG Limited
• Inventors: Zelmanov, Solomon W., Portnoy, Isaak M., Morag, Baruch A., Shifrin, Edward G., Nickelshpur, Gennady S.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/227,883
• Time in Patent Office: 613 Days
• Field of Search: 606/151, 606/153, 623/1, 623/2, 623/11, 623/12, 623/17, 623/66, 600/36, 600/37
• US Class Current: 606/151
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

A compression device for external correction of insufficient valves in venous junctions is adapted for placement around the junction. The compression device has a band encompassing at least two veins of the junction. The band has a different rigidity and compression force in a direction extending from its proximal end to its distal end. The band is formed with a main compressing portion disposed on a vein surface of the junction around an insufficient valve. Intermediate and fastening portions of the band are also disposed on the vein surfaces adjacent the main compression compressing portion. The band is preferably shaped as a Mobius band. A method for external correction of insufficient valves in venous junctions is also disclosed.

Claims

1. A compression device for external correction of insufficient valves in venous junctions, said device being adapted for placement substantially around the junction with insufficient valves in abutting contact with a desired area of said junction, comprising:

a band adapted to be disposed around at least two veins of said junction and possessing a different rigidity and compressing force in the direction from a proximal end to a distal end thereat, said band including;

at least one main compressing portion adapted to be disposed on a vein surface of said junction around the insufficient valve;

an intermediate portion disposed adjacent said at least one main compressing portion;

a fastening portion disposed adjacent said intermediate portion; and

means disposed adjacent the band for protecting the vein surface from injury.

2. A compression device according to claim 1, wherein said band is shaped as a Mobius band.

3. A device according to claim 1, wherein said band includes at least one additional compressing portion adjoining said main compressing portion, said additional compressing portion being disposed on an insufficient vein around at least another insufficient valve near said junction.

4. A device according to claim 3, wherein said main and additional compressing portions are each formed as a bifurcated end of said band.

5. A compression device for external correction of insufficient valves and adapted for placement substantially around a junction with insufficient valves in abutting contact with a desired area of said junction, comprising:

a plastic coated band of at least one of metal and alloy encompassing at least two veins of said junction and possessing a different rigidity and compressing force in the direction from a proximal end to a distal end thereof, said band comprising;

at least one main compressing portion adapted to be disposed on a vein surface of said junction around the insufficient valve;

an intermediate portion disposed adjacent said at least one main compressing portion; and

a fastening portion disposed adjacent said intermediate portion.

6. A compression device according to claim 5, wherein said main compressing portion of said band is shaped as a Mobius band.

7. A device according to claim 5, wherein said band has at least one additional compressing portion adjoining said main compressing portion, said additional compressing portion adapted to be disposed on an insufficient vein around at least another insufficient valve near said junction and formed as at least one of a semirigid and a resilient exovascular framework supporting and compressing the vein, said framework including a supporting member disposed substantially along a longitudinal axis of the vein and compressing ribs, extending from the supporting members and male and female connector means for fastening said ribs together.

8. A device according to claim 7, wherein said main additional compressing portions are each formed as a bifurcated end of said band.

9. A device according to claim 5, wherein said band is formed of metal with a spring effect.

10. A device according to claim 5, wherein said band is formed of a shape memory alloy.

11. A device according to claim 5, wherein said band is coated with a "Gore-tex" type plastic.

12. A compression device for external correction of insufficient valves in venous junctions, adapted for placement substantially around a junction surface with insufficient valves in abutting contact with a desired area of said junction surface, comprising:

a band of at least two layers of flexible fluid-impermeable plastic peripherally sealed together to form a band cavity having at least one hermetically isolated chamber, said band adapted to encompass at least two veins of said junction and possessing different rigidity and compressing force in the direction from a proximal end to a distal end thereof, said band including;

at least one main compressing portion disposed on the surface of said junction around the insufficient valve, an intermediate portion disposed adjacent said main compressing portion and a fastening portion disposed adjacent said intermediate portion; and

a material filling said band cavity to provide for vein compression and prevent reflux.

13. A compression device according to claim 12, wherein at least one of said plastic layers in said band is reinforced with at least one of a shape memory metal and an alloy.

14. A compression device according to claim 12, wherein said main compressing portion of said band is formed as a Mobius band including said at least two layers of flexible fluid-impermeable plastic peripherally sealed together, at least one of said plastic layers being reinforced with at least one of a metal and an alloy.

15. A device according to claim 12, wherein said material filling said band cavity includes at least one of a quickly solidifying biologically inert fluid and a biologically inert gas.

16. A device according to claim 12, wherein said band is formed of a plastic reinforced with metal.

17. A device according to claim 12, wherein said band has at least one additional compressing portion adjoining said main compressing portion proximate a free end thereof, said additional compressing portion adapted to be disposed on the insufficient vein around at least another insufficient valve near said junction and formed of at least one plastic layer.

18. A device according to claim 17, wherein at least one layer of said additional compressing portion is reinforced with metal.

19. A device according to claim 17, wherein the additional compressing portion is formed of at least another two plastic layers peripherally sealed together to form a second cavity having at least one hermetically isolated chamber.

20. A device according to claim 17, wherein said main and additional compressing portions are each shaped as a bifurcated end of said band.

21. A device according to claim 17, wherein said additional compressing portion is formed as at least one of a semirigid and a resilient exovascular framework adapted to support and compress the vein, said framework having a supporting member disposed substantially along the vein longitudinal axis and compressing ribs extending therefrom, and male and female connector for fastening said ribs together.

22. A method for external correction of insufficient valves in venous junctions, comprising the steps of:

a) surgically exposing the venous junction;

b) placing a correction device on the venous junction so that a main compressing portion of said correction device is sufficiently close to the junction to fully encompass a vein located outside around the insufficient valve, and a fastening portion of the device is disposed substantially on an adjacent vein;

c) determining blood reflux in the vein with an insufficient valve;

d) performing a gradual compression of the vein until the reflux disappears, by injecting a portion of at least one of a biologically inert gas and a quickly solidifying biologically inert fluid into hermetically isolated chambers of said correction device;

e) repeating step (d) by increasing or reducing compressing in certain chambers of said band;

f) determining a need for applying an additional compressing portion of said correction device;

g) when application of said additional compressing portion is necessary, disposing and fastening the latter on the vein adjusting the compression rate and said portion length, cutting off a redundant piece of same, and fastening together connectors of said additional compressing portion;

h) when application of said additional compressing portion is not necessary, cutting off the entire said additional compressing portion;

i) checking the final correction effect, determining the blood reflux in the entire junction being corrected; and

j) closing the wound by routine technique.