WO2006072926A2

WO2006072926A2 - External repair of incompetent venous valves

Info

Publication number: WO2006072926A2
Application number: PCT/IL2005/000034
Authority: WO
Inventors: Edward G. Shifrin; Gennady S. Nickelshpur; Wesley S. Moore; Andrew N. Nicolaides
Original assignee: Shifrin Edward G; Nickelshpur Gennady S; Moore Wesley S; Nicolaides Andrew N
Priority date: 2005-01-09
Filing date: 2005-01-09
Publication date: 2006-07-13
Also published as: EP1874194A2; EP1874194A4; WO2006072926A3

Abstract

The present invention relates to a method and device for repairing incompetent venous valves and more specifically, to a repair metho and an implantable support device- extravenous corrector, which is positionable about dilated veins of the Sapheno-Femoral Junction (SFJ) with the aim to apply an external compression force on the insufficient veins of the SFJ and especially in the area of the venous valves. The extravenous corrector comprises a central support member (11) and at least three band lengths (13, 15, 17), connected to the member (11), adapted for placement around at least two veins of the venous junction in the area of location of their insufficient valves, these band lengths (13, 15, 17) possessing different rigidity and compressing force in direction from their proximal end to the distal end.

Description

METHOD AND EXTRAVENOUS CORRECTOR

FOR SIMULTANEOUS REPAIR OF MULTIPLE

INCOMPETENT VENOUS VALVES

FIELD OF THE INVENTION

[0001] The present invention relates to a method and device for repairing

incompetent venous valves, and more specifically, to a repair method and

an implantable support device which is positionable about dilated veins of

the Sapheno-Femoral Junction (SFJ), with the aim to apply an external

compression force on the insufficient veins of SFJ, and especially in the

area of the venous valves. These forces tend to reapproach the valves'

leaflets and bring them closer to each other. Generally, these forces are

perpendicular to the edges of the valve cusps, tensioning the cusp edges

and bringing the valve edges into apposition to restore their competence. BACKGROUND OF THE INVENTION

[0002] Varicose veins in lower limbs is one of the most common vascular

diseases. Venous valves in humans are normally bicuspid valves in which

each valve cusp forms a reservoir for blood under pressure which forces

the free edges of the cusps together to prevent reflux. Incompetence is a

condition in which the cusps do not properly approach each other when a

pressure differential or gradient is applied across a valve permitting reflux

or retrograde flow of blood to occur. Medical literature indicates that

many physicians believe that chronic venous insufficiency (CVI) of the

lower limbs is the result of deep venous thrombosis (DVT) with

associated inflammatory changes of venous valve cusps. Varicose veins

often occur in the long saphenous veins in the medial part of the legs

when valve incompetence occurs. A varicose vein is considered to be a

condition which occurs when a vein dilates and the tributaries become

elongated and tortuous, resulting in cosmetic impairment, inflammatory

phlebitis, pain and thrombosis.

[0003] When the valves of the varicose, long saphenous vein are

examined, changes are evident including dilation, evagination between

the cusps, and in later stages the membrane between the commissures

becomes thin and may have numerous fenestrae. These conditions are

generally termed venous valve incompetence. [0004] One of the most frequent symptoms of incompetence is poor

coaptation of the valve cusps due to Soppiness of the leading edges of the

valve cusps. Reflux of blood flow occurs both along the free edges of the

cusps and in the corneal areas.

[0005] Venous valve reconstruction has progressed to the point that

competence can be achieved by both internal and external repair

techniques.

[0006] In most cases varicose veins in lower limbs occur due to

insufficiency of the SFJ. In different countries of the world, on the

average, from 40% to 60% of the female population over age 40 are

affected by lower limb varicosity. It is also very important to save these

veins for potential application thereof in aorto-coronary bypass or

peripheral arterial reconstructions.

[0007] So far no efficient methods have been developed for the

elimination of valve incompetence (insufficiency) and saving the

superficial and deep veins, especially in the SFJ area. One of the surgical

procedures to address this problem is the application of sutures to the

edges of the valve cusp leaflets in the corneal areas. The sutures are then

pulled back and tied to the walls of the vein in order to reduce the length of the coapting edges of the leaflets. For example, the "Atlas of Venous

Surgery" (1992), at page 125, dicusses various valve reconstruction

techniques for primary valve insufficiency. One of the techniques is

entitled "Internal Technique by Transvalvular Venotomy" and involves

first laying open the valve by performing a venotomy to expose the valve.

The object of the repair is to shorten the leading edge of each cusp to

restore a cup-like configuration to both cusps in a procedure termed

internal valvuloplasty. The valve is repaired with monofilament sutures at

three locations (medial, lateral and posterior) until the leading edges of

two valves lie gently across the face of the vein with the floppy, rugal

folds eliminated.

[0008] The simplest and most effective solution of the problem is an

external compression of the veins around the incompetent valves by an

extravenous corrector to reduce their central opening lumen and to restore

valves function.

[0009] There are many engineering solutions applied in medicine for

correcting defects in blood vessels and human hollow organs. [0010] Devices and methods are known for reconstructions of effected

blood vessels (U.S. Pat. No. 5,100,422 or "Venous Disorders" by John B.

BERGAN and James S.T. YAO, W.B.Saunders Company, Philadelphia,

1991, p. 303 - 311).

[0011] Devices are also known for compression of vessels or hollow

organs or securing portable medical instruments thereon (U.S. Pat. No.

5,160,338; 5,080,095; 5,171,252 or 4,938,765).

[0012] Such devices can compress the vein around the incompetent valve

and control, within certain limits, the compression force. However, these

devices cannot be disposed directly on a venous junction, and they do not

provide the desired accuracy in compression rate control.

[0013] Special devices are further known for occuring the vein (U.S. Pat.

No. 4,586,501 or 4,531,519) applied in surgery. They provide a more

accurate control of the vein compression rate. However, they cannot be

secured directly on the venous junction. Besides, they are complex in

design (with a remote pressure source) and relatively large-sized, so they

cannot constantly and independently operate inside the human body. [0014] Most similar to the present invention is the device disclosed in

U.S. Pat. No. 5,120,300 and in the book "Plastric and reconstructive

operations on great veins", by A.N. Vedensky, "Medizina", Leningrad,

1979, p.186 - 194. Such devices compise bands (U.S. Pat. No. 5,120,300)

or spiral springs formed of plastic, metal, alloy or plastic reinforced with

metal (lavsan, fluorineplastic etc.).

[0015] The common drawback of all devices described above is that

they cannot be applied for correction of vein valves, disposed in the

venous junctions.

THE PRIOR ART

[0016] U.S. Pat. 5,147,389 describes a cuff for restoring competence to

an incompetent venous valve consisting of a band of biocompatible

implantable material that is not stretchable at blood flow pressures. The

band is of sufficient length to encompass the vein at the site of the venous

valve with the ends of the band overlapping. The cuff is placed around

the vein at the site of the valve and the circumference of the cuff (and

hence the diameter of the vein at the valve site) and reduced until

competency of the valve in the vein is restored. [0017] A method of extravascular correction of the function of

incompetent vein valves and an extravascular corrector are described in

WO 09638090A1. The method cosists of exposing the affected section of

a vein, mobilising it in the region around the incompetent valve and

constructing the lumen of the vein using the corrector attached to the vein

in the region of the incompetent valve. The material used for the corrector

outer frame is an extremely resilient shape-memory alloy

(titanium/nickel). The outer frame of the corrector is in the form of a

hollow elliptical cylinder which can be helical or sinusoidal and made

from a wire or a sheet perforated in a particular way.

[0018] It is also known an implantable support device for restoring

competence to venous valves (WO 9740755 Al, EP 898463 Al, AU

2817097A1, CA 02252894AA, etc). The device has an opposed

compression member of a biocompatible material, which incorporates a

reinforcing or spring-like member such as a stainless steel wire. The

device is applied externally about a vein at an incompetent venous valve

site and serves to flatten or compress but not occlude the vein. Flattening

is induced generally normal to the coapting edges of the valve cusps

restoring the competence of the valve by causing an elongating tension to

be applied to the free edges of the cusps to bring them into apposition. [0019] The common drawbacks of all the above devices and methods are

as follows:

1) they cannot be applied for correction of vein valves, disposed in at

least two veins of said venous junctions;

2) they have only a compressing portion whereas no fixing means is

provided to prevent axial displacement of the compressing member

along the vein.

[0020] The most similar to the present invention is a compression device

and method for external correction of insufficiennt valves in venous

junction, described in U.S. Pat. 5,476,471. The compression device

adapted for placement around the junction, has a band encompassing at

least two veins of these junction. The band has different rigidity and

compression force in a direction extending from its proximal end to its

distal end. The band is formed with a main compression 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 compressing portion. The band is

preferably shaped as a Mobius band. [0021] However, this device and method present a complicated,

relatively expensive and not adequately technological design of the

implanted device. Besides, it is not sufficiently adapted for placement on

venous junctions of various shapes. The placement of the device is a

relatively long procedure, and the fixation of the fastening portion is

inconvenient.

[0022] An object of the present invention is to provide a most simple,

cheap and technologically easy device and method for a controlled

correction of an incompetent valve immediately in the venous junction,

and, if necessary, of the incompetent valve in the area adjoining said

junction.

SUMMARY OF THE INVENTION

[0023] An object of the present invention is a method and device - an

extravenous corrector, for simultaneous repair of multiple incompetent

venous valves in venous junctions. The device is adapted for placement

substantially around the junction with insufficient valves in abutting

contact with a desired area of junction. [0024] The extravenous corrector comprises a central support member

adapted to be placed on the surface of veins converging to the center of a

venous junction, as well as at least three lengths of a band connected to it

and adapted to be placed around at least two veins of the venous junction

in the area of location of insufficient valves. These lengths of band posess

different rigidity and compressing force in direction from their proximal

end to the distal end.

[0025] The central support member of the claimed extravenous corrector

is, in top view, shaped as a flat rounded geometrical figure: circle, ellipse

or polygon with rounded angles. Besides, the central support member

may have in the middle a lightened area formed at least as one hole or at

least one bulge.

[0026] Each of the band lengths may be a separate element attachable to

the central support member. At least one of the band lengths may be

shaped as a Mobius band.

[0027] The extravenous corrector may further be formed from a thin,

flexible sheet of biologically compatible metal or alloy, chosen from a

group comprising stainless steel, titanium, tantalum, nickel, zirconium,

niobium, alloys of titanium and tantalum, nitinol. In this case, the central support member and at least three band lengths connected to it may be

perforated, with through holes and rounded edges.

[0028] Each of the band lengths of the extravenous corrector may have

uneven thickness, a thinned perforated middle and thickened rounded

edges, and the holes in the middle of said band are through, with rounded

edges.

[0029] Each of the band lengths of this extravenous corrector may be

also formed as a separate element rigidly or pivotally attachable to the

central support member. In this case, in particular, the central support

member may be formed as a pivot to which at least three band lengths are

pivotally attached.

[0030] The central support member and at least three band lengths

connected to the latter may be coated with plastic. The plastic is chosen

from a group comprising polytetrafluoroethylene, porous

polytetrafluoroethylene, fluorinated ethylene propylene, perfluoro alkoxy,

polyethylene therephthalate, polyurethane, absorbable polymers and

resorbable polymers. [0031] The extravenous corrector for simultaneous repair of incompetent

valves in venous junctions may be also formed as a plastic coated thin,

flexible wire from biologically compatible metal or alloy chosen from a

group comprising stainless steel, titanium, tantalum, nickel, zirconium,

niobium, alloys of titanium and, nitinol. In this case, each of the band

three lengths is formed by at least two parallel lengths of thin, flexible

wire coated with plastic. In another embodiment, each of the three band

lengths is formed as a woven net structure containing at least two parallel

lengths of thin, flexible wire interlaced with a third length of wire. In this

case, the third length of wire may have substantially a smaller diameter

than the first two lengths.

[0032] As in the above embodiment, the central support member is, in top

view, shaped as a flat, rounded geometrical figure: circle, ellipse or

polygon with rounded angles. The central support member may have in

the middle a lightened area formed as at least one hole or at least one

bulge. At least one of the band lengths may be shaped as a Mobius band.

[0033] As in the preceding embodiment, each of the band lengths may be

formed as a separate element, rigidly or pivotally attachable to the central

support member. The central support member may be formed as a joint,

to which at least three aforesaid band lengths are pivotally attached. [0034] The central support member and at least three band lengths

attached to it are coated with plastic chosen from a group comprising

polytetrafluoroethylene, porous polytetrafluoroetylene, fluorinated

ethylene propylene, perfluoro alkoxy, polyethylene therephthalate,

polyurethane, absorbable polymers and resorbable polymers.

[0035] Finally, the extravenous corrector may comprise a central support

member and at least three band lengths connected to it which are coated

with plastic and formed as a single length of a multicore flat cable.

[0036] In the next embodiment, an extravenous corrector is formed of a

thin flexible sheet or wire of biologically compatible material. This

material may be also biologically absorbable.

[0037] According to this embodiment, the central support member of the

extravenous corrector and its at least three band lengths, connected to

the central support member, have at least one shaped recess, which has

substantially a circular or elongated ellipsoid shape. This at least one

shaped recess contains a therapeutic agent. [0038] As in the above embodiment, the therapeutic agent may be

selected from a group consisting of genetic material, growth factors,

antineoplastics, antimitotics, antiinflammatories, antiplatelets,

anticoagulants, antifibrins, antithrombins, antiproliferatives, antibiotics,

antioxidants, and antiallergic substances.

[0039] As in the above embodiment, the central support member and at

least three band lengths, connected to this central support member, have

a plurality of shaped recesses thereon, which have substantially circular

and/or elongated ellipsoid shapes. This plurality of recesses contains a

therapeutic agent.

[0040] The therapeutic agent may be selected from a group consisting of

genetic material, growth factors, antineoplastics, antimitotics, anti¬

inflammatories, antiplatelets, anticoagulants, antifibrins, antithrombins,

antiproliferatives, antibiotics, antioxidants, and antiallergic substances.

[0041] According the next embodiment of the extravenous corrector, its

central support member and at least three band lengths, connected to this

central support member, comprise an underlying structure of metallic

material, having special surface polishing, more particularly,

electropolish. [0042] An extravenous corrector according to the next embodiment, has

a central support member and at least three band lengths connected to

this central support member, and comprise an underlying structure of

metallic material, which is coated with a biologically compatible plastic,

chosen from a group including polytetrafluoroethylene, porous

polytetrafluoroethylene, fluorinated ethylene propylene, perfluoro alkoxy,

polyethylene therephthalate, polyurethane, absorbable polymers and

resorbable polymers. The extravenous corrector also comprises an

underlying structure of metallic material, which is coated with a

biologically degradable polymer, chosen from a group including

polyanchydride and polyorthoester. This biologically degradable

polymer is loaded with a therapeutic agent. And at last, the therapeutic

agent comprises heparin.

[0043] There is also proposed a method for simultaneous repair of

multiple incompetent venous valves in venous junctions comprising

several successive steps.

[0044] At the first stage, surgical exposure of the venous junction is

performed. Then, the extravenous corrector is placed outside the venous

junction in such a way that the central support member is disposed

immediately on the junction, and the three bands lengths wrap and wind

around corresponding veins of the junction. Then, blood reflux is

determined in one of the veins with incompetent valve. Thereupon, there

is performed gradual compression of this vein until the reflux disappears,

by changing the coiling force of the respective first band length. Next, the

effect is checked, and, if necessary, the step is repeated by increasing or

reducing compression via rewinding the respective first band length and

fixating its free end.

[0045] Then the second step is performed - determining the need for

adjusting the reflux in the next vein, and, if necessary, repeating the

procedure with the second band length, checking the reflux in the second

venous valve with following fixation of the free end of the second band

length, adjusting the compression rate and the length of the second band

length by cutting off a redundant piece of same. [0046] Then comes the third step - determining the need for adjusting the

reflux of still another vein, repeating procedures with the third band

length, checking the reflux in the third venous valve with following

fixation of the free end of this third band length, adjusting the

compression rate and length of said third band length by cutting off a

redundant piece of same. In the course of correcting insufficient veins at

least one of the band lengths may be wound, as a Mobius band, on the

surface of a corresponding vein.

[0047] If placement of the third and following band lengths is not

necessary, these lengths are entirely cut off.

[0048] Finally, there is performed a checking of the final correction effect

by determining blood reflux in the corrected venous junctions as a whole

and closing the junction by routine technique. In the course of correcting

insufficient veins with incompetent valves, at least one of the band

lengths may be wound, as a Mobius band, on the surface of a

corresponding vein.

[0049] The above is a brief description of some deficiencies in the prior

art and advantages of the present invention. Other features, advantages, and embodiments of the invention will be apparent to those skilled in the

art from the following description, accompanying drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The invention will now be described in conjunction with the

following drawings in which like reference numerals designate like

elements and wherein:

[0051] FIG. 1 is a general view of the most preferred embodiment of the

proposed extravenous corrector placed on the surface of a venous

junction;

[0052] FIG. 2 is a general view of a second preferred embodiment of the

proposed extravenous corrector placed on the surface of a venous

junction;

[0053] FIG. 3 is a general view of a third preferred embodiment of the

proposed extravenous corrector placed on the surface of a venous

junction; [0054] FIG. 4-6 is a general view of the most preferred embodiment of

the proposed extravenous corrector;

[0055] FIG. 7-10 are versions of a cross section of peripheral portions

of the proposed extravenous corrector;

[0056] FIG. 11-12 is a general view of the second preferred

embodiment of the proposed extravenous corrector and cross section of

its peripheral portion;

[0057] FIG. 13-15 is an embodiment of the proposed extravenous

corrector formed as a connection of several parts, as well as cross sections

of the central support member (FIG. 14) and one of peripheral

portions (FIG. 15);

[0058] FIG. 16-18 is an embodiment of the proposed extravenous

corrector as an articulation of several parts, as well as cross sections of

one of the peripheral portions (FIG. 17) and central support member

(FIG. 18); [0059] FIG. 19 is a three-dimensional position of the proposed

extravenous corrector comprising a rigid or pivotal connection of several

parts;

[0060] FIG. 20-21 is an embodiment of the proposed extravenous

corrector comprising a woven net structure, as well an enlarged fragment

of one of its peripheral portions (FIG. 21);

[0061] FIG. 22-23 is an embodiment of the claimed extravenous

corrector as a cable (a wire structure coated with plastic), and its cross

section (FIG. 23).

[0062] FIG. 24-25 is an embodiment of the proposed extravenous

corrector comprising at least one shaped recess, which has a substantially

circular or elongated ellipsoid shape. This at least one shaped recess

contains a therapeutic agent.

[0063] FIG. 26-27 is an embodiment of the proposed extravenous

corrector comprising a plurality of shaped recesses thereon, which have a

substantially circular and/or an elongated ellipsoid shape. This shaped

plurality of recesses contains a therapeutic agent. [0064] FIG. 28 is an embodiment of the proposed extravenous

corrector comprising an underlying structure of metallic material, having

special surface polishing, more particularly, electropolish.

[0065] FIG. 29 is an embodiment of the proposed extravenous

corrector comprising an underlying structure of metallic material, which

is coated with a biologically compatible plastic.

[0066] FIG. 30 is an embodiment of the proposed extravenous

corrector comprising an underlying structure of metallic material, which

is coated with a biologically degradable polymer.

DETAILED DESCRIPTION OF THE INVENTION

[0067] Below is a discription of the most preferred embodiments of the

claimed invention. As may be seen from embodiments presented in this

description, the invention can solve the problem of eliminating valve

incompetency in venous junctions (SFJ). Thus, it is intended that the

present invention cover the modifications and variations of the

invention, provided they come within the scope of the appended claims

and their equivalents. [0068] FIG. 1 is a general view of a venous junction 1 with the claimed

extravenous corrector 3 in the most preferred embodiment placed on the

surface of the device.

[0069] FIG. 2 is a general view of a venous junction (SFJ) 1, on the

surface whereof there is placed the claimed extravenous corrector 5 in

the second preferred embodiment.

[0070] And finally, FIG. 3 is a general view of a venous junction (SFJ)

1, on the surface whereof there is placed the claimed extravenous

corrector 7 in its third preferred embodiment ( with elements connected

together via a joint 9).

[0071] Extravenous corrector 3 (FIG. 4 - 6, FIG. 1) comprises a central

support member 11 adapted to be disposed on the surface of converging

veins in the center of SFJ (FIG. 1), and at least three band lengths 13, 15

and 17, connected with it and adapted to be disposed around at least two

veins of venous junction 1 in the area of location of incompetent valves.

These band lengths 13, 15 and 17 posess different rigidity and

compressing force in direction from their proximal to distal end. Central

support member 11 of the claimed extravenous corrector 3 (see FIG. 1)

is shaped, in its top view, as a flat rounded geometrical figure, in this case, substantially as an ellipse. It may be as well shaped as a circle or

polygon with, rounded angles. Besides, central support member 11 has in

its middle a lightened portion shaped as a mesh 19, which may be as well

shaped as at least one hole or at least one bulge (not shown in the

drawings).

[0072] Each of the band lengths 13, 15 and 17 may be formed integral

with central support member 11 ( FIG. 4). At the same time, each of the

band lengths 13, 15 or 17 may be a separate element, rigidly or pivotally

attachable to central support member 11 ( FIG. 13). In this case,

particularly, central support member 11 may be shaped as a pivot to

which there are pivotally attached at least three band lengths 13, 15 or 17.

[0073] In both said embodiments at least one of the band lengths 13, 15

or 17 may be shaped as a Mobius band ( FIG. 3).

[0074] In the first, most preferred embodiment ( FIG. 6 - 10), the

extravenous corrector 3 is formed of a thin, flexible sheet of a

biologically compatible metal or alloy, chosen from a group comprising

stainless steel, titanium, tantalum, nickel, zirconium, niobium, alloys of

titanium and tantalum, nitinol. In this case central support member 11 and

at least three band lengths 13, 15 or 17 connected to it may be perforated, with through holes with rounded edges. Holes 19 in central support

member 11 may be round, square, triangular ( FIG. 4) or have another

shape.

[0075] Each of band lengths 13, 15, 17 of extravenous corrector 3 may

have even thickness (see FIG. 7, 8), be formed of a metal band 21 or 25

with rounded edges, 23 and 27, respectively, and with triangular 29 or

round 31 holes in the middle, also having rounded edges. In this case,

band lengths 13, 15 and 17 are coated with a layer of plastic, 33 and 35

respectively.

[0076] Besides, each of the band lengths 13, 15, 17 of extravenous

corrector 3 may have uneven thickness ( FIG. 9, 10), a lightened

perforated middle, 37 and 39 respectively, with thickened rounded edges,

41 and 43, and the holes, 45 and 47 respectively, in the band middle are

through, with rounded edges. In these embodiments band lengths 13, 15

and 17 are as well coated with a plastic layer, 49 and 51 respectively.

[0077] In the described embodiment of extravenous corrector 3 the

central support device 11 and at least three band lengths 13,15, or 17

connected to it may be coated with plastic chosen from a group

comprising polytetrafluoroethylene, porous polytetrafluoroethylene, fluorinated ethylene propylene, perfluoro alkoxy, polyethylene

therephtalate, polyurethane, absorbable polymers and resorbable

polymers.

[0078] FIG. 11 - 18 show the second embodiment of extravenous

corrector 5 for external correction of incompetent valves in venous

junctions 1 comprising a thin, flexible wire 55 from a biologically

compatible metal or alloy, chosen from a group including stainless steel,

titanium, tantalum, nickel, zirconium, niobium, alloys of titanium and

tantalum, nitinol, the wire being coated with plastic 53. In this case each

of three band lengths 13, 15 or 17 contains at least two parallel lengths 57

and 59 of thin, flexible wire 55 coated with plastic 53 (FIG. 12), which

is, as in the previous embodiment, chosen from a group including

polytetrafluoroethylene, porous polytetxafluoroethilene, fluorinated

ethylene propylene, perfluoro alkoxy, polyethylene therephtalate,

polyurethane, absorbable polymers and resorbable polymers.

[0079] As in the previous embodiment, central support member 11 is

shaped, in top view, as a flat geometrical figure: circle, ellipse or polygon

with rounded angles. The central support member 11 in this embodiment

may as well have in its middle a lightened portion having at least one hole or at least one bulge. In this case at least one of band lengths 13, 15 or 17

may be shaped as a Mobius band.

[0080] As in the above embodiment, each of band lengths 13 15 or 17

may by formed as a separate element 61, 63, 65, rigidly or pivotally

attachable to central support member 11 ( FIG. 13 - 15). In this case

central support member 11 may be shaped as a separate element 67 ( FIG.

13 - 15) with holes 69.

{0081] FIG. 3 and 16 - 18 show an embodiment of an extravenous

corrector 7 with central support member 11 shaped as a joint 71, to which

there are pivotally attached three band lengths 13, 15, 17 formed as

separate elements 73, 75 and 77. In this case separate elements 73, 75

and 77 contain one band length 79, which is then divided into two

parallel lengths 81 and 83 (FIG. 16 - 18). All these separate elements

from wire lengths 79, 81 and 83 are coated with plastic 85 (see FIG. 16),

which, as in the above embodiments of the compression device, is chosen

from a group, including polytetrafluoroethylene, porous

polytetrafluoroethilene, fluorinated ethylene propylene, perfluoro alkoxy,

polyethylene therephthalate, polyurethane, absorbable polymers and

resorbable polymers. FIG. 19 is a three-dimensional view of extravenous

corrector 7, according to its present embodiment. [0082] FIG. 20, 21 show an embodiment of the claimed extravenous

corrector, wherein each of three band lengths 13, 15 and 17 is shaped as a

plastic coated woven net structure 91, containing at least two parallel

lengths 93 and 95 of thin, flexible wire, interlaced with a third band

length 97 (see FIG. 21, 20). In this case band length 97 may have a

substantially smaller diameter than the first two lengths (see FIG. 21).

The woven net structure 91 is coated with the same plastic as in the above

embodiments.

[0083] Next, FIG. 22, 23 show an embodiment of the extravenous

corrector wherein central support member 101 and at least three band

lengths 103, 105 and 107 connected to it, are coated with plastic and

shaped as a single length of a multicore cable 109. Cable 109 is coated

with the same plastic that is used in the above embodiments of

extravenous corrector, the three band lengths 103, 105 and 107 being

separated from cable 109 by cutting it along its longitudinal axis over a

desired length.

[0084] In the next embodiment, an extravenous corrector is formed of a

thin flexible sheet or wire of biologically compatible material. This

material may be also biologically absorbable. [0085] According to this embodiment, the central support member 121 of

the extravenous corrector and its at least three band lengths 123, 125,

127, connected to central support member 121, have at least one shaped

recess 129 (see FIGS 24, 25), which has a substantially circular or

elongated ellipsoid shape. This at least one shaped recess 129 contains a

therapeutic agent.

[0086] As in the above embodiment, the therapeutic agent may be

selected from a group consisting of genetic material, growth factors,

antineoplastics, antimitotics, antiinflammatories, antiplatelets,

anticoagulants, antifibrins, antithrombins, antiproliferatives, antibiotics,

antioxidants, and antiallergic substances.

[0087] As in the above embodiment, the central support member 131 and

at least three band lengths 133, 135, 137, connected to this central

support member 131, having a plurality of shaped recesses 139 thereon

(see FIGS 26, 27), which have a substantially circular and/or elongated

ellipsoid shapes. This shaped plurality of recesses 139 contains a

therapeutic agent. [0088] The therapeutic agent may be selected from a group consisting of

genetic material, growth factors, antineoplastics, antimitotics, anti¬

inflammatories, antiplatelets, anticoagulants, antifibrins, antithrombins,

antiproliferatives, antibiotics, antioxidants, and antiallergic substances.

[0089] According to the next embodiment of the extravenous corrector,

its central support member 141 and at least three band lengths 143, 145,

147, connected to this central support member, comprise an underlying

structure of metallic material, having special surface polishing, more

particularly, electropolish (see FIG.28).

[0090] According to the next embodiment of the extravenous corrector,

this corrector has central support member 151 and at least three band

lengths 153, 155, 157, connected to this central support member 151, and

comprises an underlying structure of metallic material, which is coated

with a biologically compatible plastic 159 (see FIG.29), chosen from a

group including polytetrafluoroethylene, porous polytetrafluoroethylene,

fluorinated ethylene propylene, perfluoro alkoxy, polyethylene

therephthalate, polyurethane, absorbable polymers and resorbable

polymers. [0091] And at last, the extravenous corrector 161 also comprises an

underlying structure of metallic material 163 (see FIG. 30), which is

coated with a biologically degradable polymer 165, chosen from a group

including polyanchydride and polyorthoester. This biologically

degradable polymer 165 is loaded with a therapeutic agent. And next,

this therapeutic agent comprises heparin.

[0092] The claimed embodiments of the extravenous corrector may be

applied on the basis of the claimed method for simultaneous repair of

multiple incompetent venous valves in venous junctions 1, the method

comprising several successive steps. Let us consider the implementing of

this method via the most preferred embodiment of extravenous corrector

3, shown in FIG. 1 and 5 - 10.

[0093] In the first step there is surgically disposed the venous junction.

Then the extravenous corrector 3 is placed outside venous junction 1 in

such a way, that central support member 11 is located immediately on

junction 1, and three band lengths 13, 15 and 17 wrap and wind around

the corresponding veins of junction 1. Then blood reflux is determined in

one of the veins with an incompetent valve. Next, there is performed

gradual compression of this vein until the reflux disappears, by changing

the force of coiling the corresponding band length, such as 13. Further, the effect is checked, and, if necessary, the operation is repeated,

increasing or reducing compression force via rewinding the

corresponding first band length 13 and fixating its free end.

[0094] Then the second step is performed - determining a need for

adjusting the reflux of the following vein and, if necessary, repeating the

operations with the second band length 15, checking the reflux in the

second venous valve with following fixation of the free end of the second

band length 15, adjusting compression rate and length of the second band

length 15 by cutting off its redundant portion.

[0095] Thereafter the third step is performed - determining a need for

adjusting one more vein, repeating the operations with the third band

length 17, checking the reflux in the third venous valve with following

fixation of the free end of third band length 17, adjusting compression

rate and length of third band length 17 by cutting off its abundant portion.

In the course of correcting insufficient veins, at least one of band lengths

13, 15 or 17 may be coiled as a Mobius band on the surface of a

corresponding vein.

[0096] When the placement of a third, fourth or following band lengths is

not necessary, these lengths are completely cut off. [0097]. At last, final correction effect is checked by determining blood

reflux in the whole corrected junction 1, and the junction is closed by

routine technique. In the course of correcting venous imnsufficiency, at

least one of band lengths 13, 15 or 17 may be coiled as a Mobius band

on the surface of the corresponding vein.

[0098] The claimed method for simultaneous repair of multiple

incompetent valves in venous junctions 1 is performed in a similar way

when other embodiments of extravenous corrector are applied.

[0099] As a whole, the application of the claimed implanted extravenous

corrector manufactured according to the described embodiments, makes

same simple, cheap and technologically efficient, as well as more adapted

for being placed on venous junctions of diverse shapes. Moreover, the

time for the corrector placement is reduced, and fixating of fastening

portion of the extravenous corrector becomes more convenient.

[0100] It should be understood that while the above is a complete

description of the preferred embodiments of the invention, various

alternatives, modifications and equivalents may be used. Therefore, the

above description should not be taken as limiting the scope of the

invention which is defined by the following claims.

Claims

C L A I M S

1. An extravenous corrector for external correction of insufficient valves

in venous junctions, said corrector being adapted for placement

substantially around the junction with incompetent valves in abutting

contact with a desired area of said junction, comprising:

- a central support member adapted for placement on the surface of

converging veins in the center of a venous junction, and

- at least three band lengths connected to said central support member

and adapted for placement around at least two veins of said venous

junction in the area of location of their incompetent valves, said at

least three band lengths possessing different rigidity and

compressing force in direction from thei proximal end to the distal

end,

whereby at least to two veins near the venous junction there is applied

an external force, acting substantially normally towards the center of a

corresponding vein and generating a required constant force to restore

union and sufficiency of a corresponding venous valve.

2. An extravenous corrector according to claim 1, wherein said central

support member is shaped, in its top view, as a flat rounded geometrical

figure : circle, ellipse, or polygon with rounded angles.

3. An extravenous corrector according to claim 1, wherein said central

support member has, in the middle, a lightened portion shaped as at least

one portion with rounded edges.

4. An extravenous corrector according to claim 1 wherein said central

support member has, in the middle, a lightened portion shaped as at least

one bulge.

5. An extravenous corrector according to claim 1 wherein at least one

of said band lengths is shaped as a Mobius band.

6. An extravenous corrector according to claim 1 wherein each of said

band lengths is formed as a separate element, attachable to said central

support member.

7. An extravenous corrector for external correction of incompetent

valves in venous junctions, said corrector being formed of a thin flexible

sheet of biologically compatible metal or alloy and adapted to be

disposed immediately around a junction with venous valves, in abutting

contact with a desired area of said junction, comprising:

- a central support member adapted to be placed on the surface of

converging veins in the center of a venous junction, and

- at least three band lengths, connected to said central support

member and adapted for placement around at least two veins of said

venous junction in the area of location of their incompetent valves,

said at least three band lengths possessing different rigidity and

compressing force in direction from their proximal end to the distal

end,

whereby to at least two veins near the venous junction there is applied an

external force, acting substantially normally towards the center of a

corresponding vein and generating a required constant force to restore

union and sufficiency of a corresponding venous valve.

8. An extravenous corrector according to claim 7, wherein said corrector

is formed of a thin flexible sheet of biologically compatible metal or alloy

chosen from a group, including stainless steel, titanium, tantalum, nickel,

zirconium, niobium, alloys of titanium and tantalum, nitinol.

9. An extravenous corrector according to claim 7, wherein said central

support member is shaped, in top view, as a flat rounded geometrical

figure: circle, ellipse, or polygon with rounded angles .

10. An extravenous corrector according to claim 7, wherein said central

support has, in the middle, a lightened portion shaped at least as one hole

with rounded edges.

11. An extravenous corrector according to claim 7, wherein said central

support member has, in the middle, a lightened portion shaped at least as

one bulge.

12. An extravenous corrector according to claim 7, wherein at least one

of said band lengths is shaped as a Mobius band.

13. An extravenous corrector according to claim 7, wherein each of said

band lengths is formed as a separate element, attachable to said central

support member .

14. An extravenous corrector according to claim 13, wherein each of

said band lengths is formed as a separate element, rigidly or pivotally

attachable to said central support member.

15. An extravenous corrector according to claim 7, wherein said central

support member and said at least three band lengths, connected to said

member, are perforated, with through holes having rounded edges.

16. An extravenous corrector according to claim 7, wherein said at least

three band lengths have uneven thickness, thinned perforated middle and

thickened rounded edges, the holes in the band middle being through

holes with rounded edges.

17. An extravenous corrector according to claim 7, wherein said central

support member is shaped as a joint whereto there are pivotally connected

said at least three band lengths.

18. An extravenous corrector according to claim 7, wherein said central

support member and said at least three band lengths connected to said

member are coated with plastic.

19. An extravenous corrector according to claim 18, wherein said

central support member and said at least three band lengths connected to

said member, are coated with a biologically compatible plastic, chosen

from a group including polytetrafluoroethylene, porous

polytetrafluoroethylene, fluorinated ethylene propylene, perfluoro alkoxy, polyethylene therephthalate, polyurethane, absorbable polymers and

resorbable polymers.

20. An extravenous corrector for external correction of incompetent

valves in venous junctions, said corrector being formed of a plastic-

coated thin, flexible wire from a biologically compatible metal or alloy,

adapted to be disposed immediately around a junction with venous

valves, in abutting contact with a desired area of said junction,

comprising:

- a central support member adapted to be disposed on the surface of

converging veins in the center of a venous junction , and

- at least three band lengths formed of plastic-coated wire and

connected to said central support member and adapted to be

disposed around at least two veins of said venous junction in the

area of location of their incompetent valves, said at least three band

lengths possessing different rigidity and compressing force in

direction from their proximal end to the distal end,

whereby to at least two veins near a venous junction there is applied an

external force, acting substantially normally towards the center of a

corresponding vein , generating a required constant force to restore union

and sufficiency of a corresponding venous valve.

21. An extravenous corrector according to claim 20, wherein said

corrector is formed of a thin flexible wire from a biologically compatible

metal or alloy, chosen from a group including stainless steel, titanium,

tantalum, nickel, zirconium, niobium, alloys of titanium and tantalum,

nitinol.

22. An extravenous corrector according to claim 20, wherein said

corrector is woven from a thin flexible wire coated with plastic.

23. An extravenous corrector according to claim 20, wherein each of

said three band lengths is formed at least by two parallel lengths of thin

flexible wire coated with plastic.

24. An extravenous corrector according to claim 20, wherein each of

said three band lengths is shaped as a plastic-coated woven net structure,

having at least two parallel lengths of thin flexible wire interlaced with a

third wire length.

25. An extravenous corrector according to claim 20, wherein each of said

three band lengths is shaped as a plastic-coated woven net structure,

having at least two parallel lengths of thin flexible wire interlaced with a third wire length with a substantially smaller diameter than that of the

first two lengths.

26. An extravenous corrector according to claim 20, wherein said

central support member is shaped, in top view, as a flat rounded

geometrical figure: circle, ellipse, or polygon with rounded angles.

27. An extravenous corrector according to claim 20, wherein said

central support member has in the middle a lightened portion formed as at

least one hole .

28. An extravenous corrector according to claim 20, wherein said

central support member has in the middle a lightened portion shaped as at

least one bulge.

29. An extravenous corrector according to claim 20, wherein at least one

of said band lengths is shaped as a Mobius band .

30. An extravenous corrector according to claim 20, wherein each of said

band lengths is formed as a separate element, attachable to said central

support member.

31. An extravenous corrector according to claim 30, wherein each of

said band lengths is formed as a separate element, rigidly or pivotally

attachable to said central support member.

32. An extravenous corrector according to claim 20, wherein said

central support member is formed as a joint to which there are pivotally

connected said at least three band lengths.

33. An extravenous corrector according to claim 20, wherein said central

support member and said at least three band lengths connected to said

member, are coated with plastic.

34. An extravenous corrector according to claim 33, wherein said

central support member and said at least three band lengths connected to

said central support member, are coated with a biologically compatible

plastic, chosen from a group including polytetrafluoroethylene, porous

polytetrafluoroethylene, fluorinated ethylene propylene, perfluoro alkoxy,

polyethylene therephthalate, polyurethane, absorbable polymers and

resorbable polymers.

35. An extravenous corrector according to claim 20, wherein said central

support member and said at least three band lengths, connected to said

central support member, are covered with plastic and shaped as a single

length of a multicore flat cable.

36. An extravenous corrector for external correction of incompetent

valves in venous junctions, said corrector being formed of a thin flexible

sheet or wire of biologically compatible material and adapted to be

disposed immediately around a junction with venous valves, in abutting

contact with a desired area of said junction, comprising:

- a central support member adapted to be placed on the surface of

converging veins in the center of a venous junction, and

- at least three band lengths, connected to said central support

member and adapted for placement around at least two veins of said

venous junction in the area of location of their incompetent valves,

said at least three band lengths possessing different rigidity and

compressing force in direction from their proximal end to the distal

end,

whereby to at least two veins near the venous junction there is applied an

external force, acting substantially normally towards the center of a

corresponding vein and generating a required constant force to restore

union and sufficiency of a corresponding venous valve.

37. An extravenous corrector according to claim 36, wherein said

corrector is formed of a thin flexible sheet or wire from biologically

absorbable material.

38. An extravenous corrector according to claim 36, wherein said central

support member and said at least three band lengths, connected to said

central support member, have at least one shaped recess.

39. An extravenous corrector according to claim 38, wherein said at least

one shaped recess has a substantially circular shape.

40. An extravenous corrector according to claim 38, wherein said at least

one shaped recess is an elongated ellipsoid.

41. An extravenous corrector according to claim 38, wherein said at least

one shaped recess contains a therapeutic agent.

42. An extravenous corrector according to claim 41, wherein said

therapeutic agent is selected from a group consisting of genetic material,

growth factors, antineoplastics, antimitotics, antiinflammatories,

antiplatelets, anticoagulants, antifibrins, antithrombins, antiproliferatives,

antibiotics, antioxidants, and antiallergic substances.

43. An extravenous corrector according to claim 36, wherein said central

support member and said at least three band lengths, connected to said

central support member, have a plurality of shaped recesses thereon.

44. An extravenous corrector according to claim 43, wherein said

plurality of shaped recesses are substantially circular.

45. An extravenous corrector according to claim 43, wherein said shaped

plurality of recesses are an elongated ellipsoid.

46. An extravenous corrector according to claim 43, wherein said shaped

plurality of recesses have a substantially circular and/or an elongated

ellipsoid shape.

47. An extravenous corrector according to claim 43, wherein said

shaped plurality of recess contains a therapeutic agent.

48. An extravenous corrector according to claim 47, wherein said

therapeutic agent is selected from a group consisting of genetic material,

growth factors, antineoplastics, antimitotics, antiinflammatories,

antiplatelets, anticoagulants, antifibrins, antithrombins, antiproliferatives,

antibiotics, antioxidants, and antiallergic substances.

49. An extravenous corrector for external correction of incompetent

valves in venous junctions, said corrector being formed of a thin flexible

sheet or wire of biologically compatible material and adapted to be

disposed immediately around a junction with venous valves, in abutting

contact with a desired area of said junction, comprising:

- a central support member adapted to be placed on the surface of

converging veins in the center of a venous junction, and

- at least three band lengths, connected to said central support

member and adapted for placement around at least two veins of said

venous junction in the area of location of their incompetent valves,

said at least three band lengths possessing different rigidity and

compressing force in direction from their proximal end to the distal

end,

whereby to at least two veins near the venous junction there is applied an

external force, acting substantially normally towards the center of a

corresponding vein and generating a required constant force to restore

union and sufficiency of a corresponding venous valve.

50. An extravenous corrector according to claim 49, wherein said central

support member and said at least three band lengths connected to said

central support member, comprise an underlying structure of metallic

material, having special surface polishing, more particularly,

electropolish.

51. An extravenous corrector according to claim 49, wherein said

corrector is formed of a thin flexible sheet or wire from biologically

absorbable material.

52. An extravenous corrector according to claim 49, wherein said

central support member and said at least three band lengths connected to

said central support member, comprise an underlying structure of metallic

material, which is coated with a biologically compatible plastic, chosen

from a group including polytetrafluoroethylene, porous

polytetrafluoroethylene, fluorinated ethylene propylene, perfluoro alkoxy,

polyethylene therephthalate, polyurethane, absorbable polymers and

resorbable polymers.

53. An extravenous corrector according to claim 49, wherein said central

support member and said at least three band lengths connected to said

central support member, comprise an underlying structure of metallic

material, which is coated with a biologically degradable polymer, chosen

from a group including polyanchydride and polyorthoester.

54. An extravenous corrector according to claim 51, wherein said

biologically degradable polymer is loaded with a therapeutic agent

55. An extravenous corrector according to claim 54, wherein said

therapeutic agent comprises heparin.

56. A method for simultaneous repair of multiple incompetent venous

valves in venous junctions, comprising the following successive steps:

- surgically exposing the venous junction;

- placing an extravenous corrector outside the venous junction so that

the central support member is disposed immediately on the

junction, and said three band lengths wrap and wind around

corresponding veins of the junction;

- determining blood reflux in one of the veins with an insufficient

valve;

- performing a gradual compression of the vein until the reflux disappears, by changing the force of coiling the corresponding first

band length;

- checking the effect and, if necessary, repeating the procedure, by

increasing or reducing compression via rewinding the first band

length and fixating its free end;

determining a need for adjusting the reflux of a following vein;

- repeating the procedures with the second band length, checking the

reflux in the second venous valve with following fixation of the

free end of said second band length, the compression rate and

length of the second band length being adjusted by cutting off the

redundant portion;

- determining a need for adjusting reflux of one more vein;

- repeating the procedures with the third band length, checking reflux

in the third venous valve , adjusting the compression rate and length

of the third band length by cutting off its redundant portion;

- when application of one of said band lengths is not necessary,

cutting off this entire length;

- checking the final correction effect by deteraiining the blood reflux

in the entire venous junction being corrected, and

- closing the junction by routine technique.

57. A method for simultaneous repair of multiple incompetent venous

valves in venous junctions according to claim 56, wherein, in the

course of correcting insufficient veins, at least one of said band lengths

is coiled as a Mobius band on the surface of a corresponding vein.