WO2012034980A1 - Probe for subcutaneous drainage during vein removal - Google Patents

Abstract

The present invention relates to a probe (1) for subcutaneous drainage, consisting of a flexible elongated tube (2) which has a longitudinal channel (3), comprising, at the distal end thereof, an orifice (4) for attachment of a vein stripper and, at the proximal end thereof, a connecting device (5), characterized in that the wall of the tube (2) is pierced with a plurality of holes (6).

Description

 Probe for subcutaneous drainage during waking

GENERAL TECHNICAL FIELD The present invention relates to the field of surgical wicking devices.

STATE OF THE ART Permanent dilatation of one or more veins is a common circulatory pathology, commonly known as varicose vein. The large diameter (> 3mm), in addition to the sinuous aspect of the affected veins, disrupts the unidirectional flow of blood to the heart, the valves no longer providing their antireflux function.

 In 95% of the cases, the varicose veins mainly affect the saphenous veins, that is to say the superficial veins that go up along the leg, and their collateral veins. These varicose veins are the result of a set of risk factors (heredity, excess weight, pregnancy, etc.). If the first symptoms of varicose veins are little more than itching, a feeling of heavy legs and unattractive veins dilated, more serious complications such as deep vein thrombosis can occur.

 Medication and / or mechanical (low compression) treatments can restore good circulation and block the development of varices, but surgery is required in the most advanced cases.

 This operation consists of a veneer, that is to say the ablation of a vein, here the main saphenous vein with sometimes its branches, according to a method called varisectomy (better known under the terminology Anglo-Saxon "stripping >> ).

The main saphenous vein extends over the entire length of the leg. Once removed, the venous circulation continues normally through a network of deep veins that communicates with the network of superficial veins via perforating veins.

 During stripping, an incision is made at the crease of the groin, another at the ankle (both ends of the main saphenous vein). The saphenous vein is strung along its entire length with a flexible stem. By the other incision, a clip called stripper (stripper in English terminology) is attached to the end of the flexible rod and attached to the vein. It can be removed by turning it around like a glove finger until it is completely removed by the first incision.

 This method has the advantage of being relatively non-traumatic, leaving only small invisible scars.

 However, hematomas that are sometimes extensive on the old vein pathway are usually observed. These can be painful and require draining a posteriori during additional interventions.

 US Patent 6,030,096 discloses a stripping device in which the rod has been replaced by a tube. Two orifices at the stripper make it possible to release vasodilator pumped into the tube. This facilitates the operation by reducing the risk of clot, but does not reduce hematoma.

PRESENTATION OF THE INVENTION

The present invention aims to substantially improve the comfort and recovery of the patient after the operation, by solving the problem of hematomas.

 The present invention thus relates to a probe for subcutaneous drainage consisting of a flexible elongate tube provided with a longitudinal channel, comprising at its distal end a fixing orifice of a vein-puller and at its proximal end a connector connecting piece, characterized in that the wall of the tube is pierced with a plurality of holes.

According to other advantageous and non-limiting characteristics • the probe has a length between 125 and 145 cm;

 • the probe has a diameter between 18 and 21 french;

 The holes are distributed in such a way that any generatrix of the cylinder formed by the tube meets at least one hole;

A part of the tube in the vicinity of the distal end is not pierced with holes;

 The portion without holes has a length of between 10% and 50% of the total length of the probe;

 • the holes are ellipses about 5 mm long;

· The holes are spaced at a constant pitch, approximately equal to 2 cm;

 The holes have a helical disposition along the tube;

 • the probe is at least partially radiopaque;

 The tube is made of a biocompatible material chosen from polyurethane and silicone.

PRESENTATION OF FIGURES

Other features and advantages of the present invention will appear on reading the following description of a preferred embodiment. This description will be given with reference to the appended drawings in which:

 FIG. 1 is a diagram of an embodiment of a probe according to the invention;

 FIGS. 2a to 2d are diagrams of different steps of a stripping operation using a probe according to the invention;

DETAILED DESCRIPTION

A probe 1 for subcutaneous drainage according to the invention is shown in FIG. This probe 1 consists of a tube 2 provided with a longitudinal channel 3. The channel 3 extends over the entire length of the tube 2. It opens on the proximal end of tube 2 and is optionally blind at the distal end thereof. It will be noted that the probe 1 according to the invention is in no way intended solely for the waking of a main saphenous vein, although this is the vein concerned by this operation, but may be adapted to the worming of the saphenous vein. any vein of the body, the skilled person will choose a length and a diameter suitable for the tube 2. In the following description, will be more particularly described an embodiment of the invention adapted to the vein stripping saphenous vein. Subcutaneous drainage is referred to as the main saphenous vein is a superficial vein that passes just under the skin of the leg. The hematomas are all the more visible. In the case of the saphenous vein, the tube 2 is preferably of a length of 125 to 145 cm, since it is necessary to insert it over the entire length of the leg of an adult person. At the distal end of the tube 2, there is a fixing orifice 4, for example a puncturing eyelet from one end of the tube 2. This orifice 4 allows via a pull wire, of a length of for example a few centimeters, to connect the tube 2 to a vein 7 (stripper in English terminology), so that the probe 1 follows the tire-vein 7 during the tearing of the vein. Many types of vein remover 7 are known to those skilled in the art, these generally having a pearl or mushroom shape (these forms being adapted to vein tearing) most often pierced with a needle. or several ports through which the pull wire can be passed.

In general, during a stray the tire-vein 7 is mounted on a rod 9, relatively rigid, making the length of the leg of the patient. As explained above, it is by this rod 9 that during the surgical procedure an operator trains the vein-puller 7 to remove the vein. By the connection between the tire-vein 7 and the probe 1, any traction on the rod 9, and thus on the tire-vein 7, is transmitted 1 to the probe. Note that the invention is not limited to the use of any type of tire-vein in particular, and one skilled in the art will adapt it accordingly, in particular the attachment of pull wire pulls -veine 7. It is for example quite possible to fix the pull wire directly on the rod 9.

The tube 2 is pierced with a plurality of holes 6. These holes 6 connect the outside of the probe 1 and the channel 3 which passes through the tube 2. It is thanks to these holes 6 that the probe 1 will fulfill its function drainage.

 Indeed, at the beginning of the operation, the vein to be eradicated is filled with blood. It is this blood which is responsible for the hematomas as well as that contained in the various collaterals of the main venous trunk which are torn from their ostiums (that is to say the cavities occupied by the veins) during the removal of the trunk. main venous: this refluxed blood is found in the path of the eveinage. Indeed, when the vein is extirpated, it is gradually as the operation folded on itself. Its volume decreases, and the blood is put under pressure. A part escapes from the vein and is released in the body, it causes bruising.

 Thanks to the holes 6 along the probe according to the invention, during compression the blood released on the path of the vein passes into the channel 3.

 At its proximal end, the probe 1 comprises a connection connection 5, for example to a suction. This connection 5 is connected to the channel 3, and thus allows to evacuate the blood passed in the tube 2. Advantageously, it is a mechanical suction, which puts the channel 3 in depression to facilitate the drainage of blood.

The tube 2 is preferably of a diameter of 18 or 21 French (abbreviation of French Gauge, it is a unit of measurement of the external diameters of the catheters and probes, corresponding to 1/3 of a mm. standard probes, 6 and 7 mm). In fact, if a healthy saphenous vein of adult has an average diameter of 3 to 5 mm, in case of varices this diameter often reaches 8 mm. By taking probes of 6 or even 7 mm in diameter, that is to say of a diameter substantially of the order of that of a saphenous saphenous vein, drainage will be more effective since in many points the surface of the tube 2 will be in contact with the inner wall left alive by tearing the vein. During the gradual entry of the probe 1 during the operation, the remaining blood pockets are thus isolated, and will be drained as soon as a hole 6 passes at their level. The distribution and the shape of the holes 6 advantageously follow several rules. The invention is however not limited to any of them.

 First, the holes 6 can be distributed in such a way that any generatrix of the cylinder formed by the tube 2 meets at least one hole 6. By this, it is meant that the holes 6 are "distributed over the entire circumference" of the tube 2: indeed a cylinder can be defined as the union of a family of parallel lines, these lines being called the generators. Now, during the displacement of the probe 1 in the vein (or rather its ostium, the probe 1 moving in the cavity left vacant by the simultaneous tearing of the vein), any point of the internal surface is swept by a generator of the Thus, thanks to the preferred geometry where the holes 6 are distributed so as to meet any generatrix, the entire internal surface of the ostium will be overflown at least once by a hole 6. No blood bag can not remain blocked.

Then, the holes are preferably ellipses, whose length parallel to the axis of the tube is about 5 mm. This geometry promotes the drainage of blood without being abrasive for the wall of the ostium, consisting of tissues that were immediately on the periphery of the vein, already damaged by tearing. It is preferable that the width of the holes 6 (the length of the minor axis in the case of elliptical holes) is as large as possible, advantageously at least 2 mm, and still more advantageously the diameter of the channel 3, in particular so that the section of each hole 6 is at least equal to the section of the channel 3. In effect during the duration of the operation the blood begins to coagulate, and its viscosity increases. Early clots could clog some of the holes 6 if they were too small. The section of the holes 6 is for example constant over their entire depth to the channel 3, but can also be tapered to increase the area swept by the holes.

 In addition, to avoid the appearance of weaknesses in the tube 2, the holes 6 are preferably distributed in a regular pitch (step is here denoted the vertical position difference between two consecutive holes, but we can consider to consider rather the direct distance from one hole to another in the curvilinear abscissa), for example one every 2 cm. A preferred arrangement of the holes follows the shape of a helix, or even a double helix.

 Finally, advantageously a portion 2a of the tube 2, extending over a length of 10 to 60 cm from the proximal end (or representing between 1/10 and ½ of the length of the tube 2), is devoid of holes 6 Indeed, it is this part which is the last one to enter the ostium of the vein during the progression of the probe 1. The absence of holes on this part 2a makes it possible to prevent the calls of air and to have on the end of the operation suction via the connector 5 to its maximum efficiency. The holes extend over a portion 2b which advantageously goes up to a few centimeters, typically 3 cm, from the distal end of the tube 2, since the closing orifice 4 is approaching.

The material of the tube 2 is for example medical grade polyurethane or silicone, and generally a flexible biocompatible material (so as to be able to follow the path of the vein with its turns), but with however a certain rigidity necessary to be able to advance the probe 1 in the ostium without it bending and getting stuck. The diameter of the channel relative to the outside diameter is also adjusted according to the flexibility of the material, for example a ratio of ¾ may be chosen.

These two materials, without being alone, also have the advantage of being radiopaque, that is to say visible on an X-ray. Choosing a material such as tube 2 is radiopaque allows to possibly envisage a guide via fluoroscopy in some cases during the surgical procedure, and may allow to find a fragment if the probe 1 was to give way under the effect of traction.

 It is also possible to add radio-opaque inserts in a generally radiolucent material.

Example of a probe according to the invention A particularly preferred probe according to the invention consists of a polyurethane probe whose tube 2 has an outside diameter of 6 mm, and an inside diameter of 4 mm. The holes 6 are ellipses 5 mm long and 4 mm wide with a constant section (to correspond to the diameter of the channel 3).

 Arranged helically (it is possible to envisage a simple helix or even a double helix), the holes 6 are shifted by one eighth of a turn (45 °) to each stage, so as to slightly overlap in projection on a section of the tube 2. The direction of rotation is not important. Two consecutive holes 6 have a gap of 2 cm in a vertical position, from center to center. A complete rotation of the propeller is therefore in 16 cm. By choosing a 125 cm long probe, part 2a measures 25 cm, part 2b measures 96 cm and thus comprises 6 complete helices, so as to leave 4 cm between the last hole 6 and the distal end comprising the orifice 4.

 Such a probe has optimal performances for the drainage of the hematomas: thanks to the 6 propellers, each point of the internal surface is scanned 6 times during the operation, from which a total evacuation of the pockets of blood which can not remain blocked .

Stripping operation FIGS. 2a-d show four stages of the extraction of a varicose vein (or any other blood vessel) using a probe according to the invention

 Figure 2a is a diagram of the vein before the operation. An incision is made at each of its two extremities (usually the ankle and groin, in the case of the main saphenous vein).

 By the first of these two incisions, the operator puts on the entire length of the vein the rod 9, and sets at its end a tire-vein 7 by the other of these incisions, as shown in Figure 2b. It tightens the vein by a ligation 8 just at the base of the vein-shooter 7. In most cases, as explained a tire-vein 7 is indeed similar to a bead. With ligation 8, the diameter of the vein is reduced to a bottleneck, blocking the passage of the vein-tire 7. It is he who allows "tear" the vein.

 The distal end of the probe 1 is introduced by the second incision and then linked to the tire-vein 7 by the eyelet 4 attachment provided at this end.

 Thus, the operator has only to pull on the rod 9 by the end protruding from the first incision to extract the vein, which is carried by the tire-vein 7. The probe 1 is then pulled through the vein to the first incision, as seen in Figure 2c. The vein folds upside down, and the blood escapes into the body via the neck of the vein at the level of the tire-vein 7. It flows back to the probe 1. The holes 6 allow its transfer into the channel 3 and easy evacuation.

 When the probe 1 has entered its entire length in the ostium, as can be seen in FIG. 2d, only the portion 2a without holes 6 protrudes. The suction is at its maximum, back and forth will further improve the complete evacuation of blood pockets that may remain.

 To complete the operation, the operator slices the probe at the portion 2a, to separate the end 5 from the rest, and it is extracted with the vein by continuing to pull the rod 9.

Claims

1. Probe (1) for subcutaneous drainage consisting of a flexible elongate tube (2) provided with a longitudinal channel (3), comprising at its distal end a port (4) for fixing a vein-puller and at its proximal end a connection connector (5), characterized in that the wall of the tube (2) is pierced with a plurality of holes (6). 2. Probe according to the preceding claim, characterized in that it has a length of between 125 and 145 cm. 3. Probe according to the preceding claim, characterized in that it has a diameter between 18 and 21 french. 4. Probe according to one of the preceding claims, characterized in that the holes (6) are distributed such that any generatrix of the cylinder formed by the tube (2) meets at least one hole (6). 5. Probe according to one of the preceding claims, characterized in that a portion of the tube (2a) in the vicinity of the distal end is not pierced with holes (6). 6. Probe according to the preceding claim, characterized in that the portion (2a) without holes has a length of between 10% and 50% of the total length of the probe (1). 7. Probe according to one of the preceding claims, characterized in that the holes (6) are ellipses of about 5 mm long. 8. Probe according to one of the preceding claims, characterized in that the holes (6) are spaced a constant pitch, approximately equal to 2 cm. 9. Probe according to one of the preceding claims, characterized in that the holes (6) have a helical disposition along the tube (2). 10. Probe according to one of the preceding claims, characterized in that it is at least partially radiopaque. 11. Probe according to one of the preceding claims, characterized in that the tube (2) is a biocompatible material selected from polyurethane and silicone.