WO2011091483A1

WO2011091483A1 - Surgical thread and surgical device for lifting and suspension of soft tissues.

Info

Publication number: WO2011091483A1
Application number: PCT/BE2010/000005
Authority: WO
Inventors: Philippe Ehlinger
Original assignee: Dokter Philippe Ehlinger, Besloten Vennootschap Met Beperkte Aansprakelijheid
Priority date: 2010-01-26
Filing date: 2010-01-26
Publication date: 2011-08-04

Abstract

Surgical thread (7) for lifting and suspension of soft tissues, characterized in that the thread (7) comprises two thread parts (8-9), both thread parts (8-9) being formed as a wire with retention means (11) for lifting facial tissues and being separated by means of an intermediate wire (14), the retention means (11) being effective in a single direction directed from one extremity of the thread part (8-9) towards the intermediate wire (14).

Description

Surgical thread and surgical device for lifting and suspension of soft tissues.

The present invention concerns a surgical thread and surgical device for lifting and suspension of soft tissues.

More in particular the invention is well suited for facial rejuvenation by means of facelift surgery.

Facial rejuvenation has been performed since several decades by means of surgical treatments such as for example superficial or deep-plane facelifts. Although these classical facelifts have proven to be effective for several years, these surgical treatments also have some major drawbacks.

One of the main disadvantages is that these surgical facelifts are generally carried out under general anesthesia and thus they all have some risks and complications related thereto.

Specifically for this type of surgical treatment there are risks of particular complications such as nerve damage, skin necrosis, hematoma, infections and the like.

Another disadvantage of these surgical facelifts is that they result in an unnatural "surgical" look for some patients. Another disadvantage of these surgical methods is that the patient suffers from the treatment not only physically but also psychologically, since these methods have an impact on the patient's daily life due to hospitalization, absence at work and social impairment for several weeks.

Moreover these surgical facelifts are expensive.

Furthermore, these known surgical facelifts are not suited for all patients. Particular contra-indications exist, like for example for smoking patients.

Finally, due to the foregoing disadvantages, surgical treatment is normally postponed as long as possible, and thereby causing dramatic changes once it is effectively done .

Although less invasive facial rejuvenation treatments exist, such as the use of lasers, Botox®, fillers or such, they cannot be used as a substitute for the surgical facelift as described above.

Said known less invasive methods have all proven to be efficient only for some specific indications.

A major disadvantage is that they cannot correct sagging of facial tissues due to gravity, excess of skin and laxity, and thus all these treatments result in a temporarily better looking, but they need to be carried out again once the effect has disappeared. Recently, procedures using suspension threads to lift facial tissues are known.

Although the use thereof has proven to be more effective than the foregoing methods, one of the main disadvantages is that they also require open surgery, thus having the same drawbacks and risks as the classical facelift.

Suspension threads have also been used in closed procedures. However, in these cases the results have proven to be disappointing and were only temporarily visible.

The present invention aims to remedy one or more of said disadvantages by providing a surgical thread for lifting and suspension of soft tissues, whereby the thread comprises two thread parts, both thread parts being formed as a wire with retention means for lifting soft tissues and being separated by means of an intermediate wire, the retention means being effective in a single direction directed from one extremity of the thread part towards the intermediate wire.

By using such device according to the invention for a facelift, the surgical thread can be put in position with the two thread parts introduced in the soft facial tissue to be lifted, while the thread is suspended on the zygomatic arch with the intermediate wire the purpose of which is to anchor the thread firmly into the skull or onto the facial skeleton. Contrary to the known methods for facial suspension, the present device according to the invention allows to create a surgical scar between superficial and deep facial tissue layers .

The presence of this scar between these different layers causes the facial tissues to remain in position. As such in the course of time, the deep and superficial tissue layers will adhere and will not slide or move between them.

Therefore, these tissue layers will not suffer too much from gravity forces, resulting in a longer lasting lifting effect . A second characteristic of the present invention related to said long term effect is the firm anchorage of the device, more in particular the skeletal anchorage of the device to the zygomatic arch. One of the advantages of the device is that it allows to treat patients under local anesthesia and that it also offers the possibility to treat patients with contraindications for classical facelift. Of course, other advantages related thereto include limited financial costs for the patient, less risks, short absence at work and short social impairment.

Another advantage related thereto is that the use of this surgical thread is also considered to be interesting for patients at an earlier age. Another advantage is that the application of this surgical thread results in a more refined, more natural looking result and that it is also possible to adjust the result a few days after the treatment.

Moreover, if necessary, it is even possible to remove the surgical thread via a small intra-oral incision. One of the main advantages is that the placement of the surgical thread in the soft facial tissue layers results in the creation of a scar between the subcutaneous, superficial musculo-aponeurotic and periostal layers, without risk of nerve damage or impairment of mimic activity.

According to a preferred embodiment the retention means comprise a series of retention elements provided at regular distances from each other and having the shape of hooks, cones, barbs or the like oriented in the same direction.

According to the most practical embodiment, the length of the intermediate wire is longer than half the circumference of the cross section of the zygomatic arch; so that when the thread is placed over the zygomatic arch with the intermediate wire surrounding the zygomatic arch, the intermediate wire is guided through the tissue until the intermediate wire contacts the bone of the zygomatic arch. An advantage is that the retention means help to hold the tissue under tension in the adjusted position and further improve anchoring the device to the patient's facial tissue .

The present invention also relates to a surgical device for lifting and suspension of soft tissues, whereby said device comprises at least the surgical thread as described above and a needle for introducing the thread into the soft tissue by moving and guiding the thread by means of the needle and whereby the thread is provided with removable cover means to temporarily cover the retention means of one thread part for moving the thread through the soft tissue in a direction opposite to the effective single direction of the concerned thread part. An important advantage is that the use of the device allows to enter the soft tissue with a puncture or an incision of minimum size and to position the surgical thread at the appropriate location in a less invasive and less time- consuming way.

With the intention of better showing the characteristics of the invention, hereafter, as an example without any limitative character, a preferred form of embodiment is described of a surgical device according to the invention, with reference to the accompanying drawings, wherein: figure 1 schematically represents a needle which is part of the surgical device according to the invention ;

figure 2 schematically represents the surgical thread according to the invention; figure 3 schematically represents an alternative embodiment of the surgical thread of figure 2;

figures 4 to 9 schematically represent subsequent steps of a method of facial lifting by means of the surgical device according to the invention.

Figure 1 schematically represents a guiding needle 1 being part of the surgical device 2 according to the invention. Said guiding needle 1 is built of a holder 3 with a preferably small needle 4 ending in a sharp tip 5.

Depending on the surgery to be carried out and the corresponding surgical thread to be used, said needle 4 should be chosen long enough.

According to the most practical embodiment, the needle 4 is provided with an eyelet or hole 6 for passing the surgical thread 7 according to the invention into the guiding needle 1.

Although preferred, it is not strictly necessary for the invention that the eyelet 6 is provided in the vicinity of the tip 5 and it is also possible that other means are provided in the vicinity of the tip for mounting or coupling the surgical thread 7 to the guiding needle 1.

As can be seen from figure 2, said surgical thread 7 comprises at least two similar thread parts 8-9. In the most practical embodiment, the length of each thread part 8-9 is sufficiently long such that it can extend from the zygomatic arch to any facial tissue to be lifted. More in particular, it is preferable that each part 8-9 is long enough in order to extend from the zygomatic arch to at least the naso-labial fold.

By way of example without being limitative, the length of these thread parts 8-9 should be at least 8 centimeter, when the thread is used for mid-face lifting, or at least 10 centimeter, when the thread is used for neck lifting too . Both thread parts 8-9 mainly comprise a wire 10, preferably from a supple and/or non-resorbable suture material, such as metal or nylon. Of course, other materials, whether or not resorbable, elastic or non-elastic, but suitable for use into the human body are not excluded.

According to the invention, both thread parts 8-9 are provided with retention means 11 along at least a portion of the longitudinal length of the part 8-9 concerned. In a practical embodiment of the invention, these retention means 11 are present over at least 6 centimeter of the thread part, or even better over at least 8 centimeter.

In the embodiments of figures 2 and 3, the retention means 11 are provided as a series of identical retention elements 12, however it is not excluded to provide a series of different elements.

Moreover in the embodiment of figures 2 and 3, the retention elements 12 are provided at regular distances from each other, which is also not strictly necessary for the present invention.

Preferably, each retention element 12 has the shape of a hook, a barb, a cone or the like for enhancing the efficiency of suspension of facial tissues, whereby these retention means 12 can be moved easily in one direction in the facial tissue, whereas in the opposite direction such a movement is not possible without undue force whereby the tissue is damaged.

According to the invention, the retention means 11 are effective in a single direction, more in particular along the longitudinal direction of the thread part 8-9.

In the embodiment shown in figure 3, one thread part 8 is provided with removable covering means 13, which aim to cover the retention means 11 of the thread part 8. In a preferred embodiment, these removable covering means 13 consist of a cylindrical silicon tube which is provided around at least the barbed portion of the thread part 8.

Other alternative covering means 13 could be a trocar or a tube of another material. According to the invention, the surgical thread 7 further comprises an intermediate wire 14 situated between both above-mentioned thread parts 8-9 and connecting both thread parts 8-9.

More in particular the intermediate wire 14 connects one extremity 15 of a first thread part 8 to an extremity 16 of the other 9. It is preferable to provide the intermediate wire 11 in a non-resorbable and supple material, although alternative materials, whether or not resorbable, are not excluded from the present invention. Of course, in the most practical embodiment of the invention, the intermediate wire 14 is made of the same material as the wire 10 of the thread parts 8-9.

In the most practical embodiment of the invention the surgical thread 7 is formed of a single, continuous wire whereby two separate sections of this wire are provided with retention means 11.

Contrary to the thread parts 8-9, it is preferable that the intermediate wire 14 is a neutral wire with no retention means 11.

Preferably, the length of the intermediate wire 14 is longer than half the circumference of the cross section of the zygomatic arch. In a practical embodiment of the present invention, this intermediate wire 14 has a length between 1 and 8 centimeter, more preferably between 2 and 4 centimeter, and even more preferably a length of approximately 3 centimeter.

In a preferred embodiment, one of the thread parts 8-9 is extended with an additional guiding thread part 17, preferably from a material suitable for use into the human body.

Said guiding thread part 14 is preferably made in the shape of a wire without retention means and its free extremity 18 is suited to be used in conjunction with the guiding needle 1.

Of course, it is possible that the surgical thread 7 is formed as a wire with four adjacent sections, whereby the first and third sections are provided with retention means and whereby the remaining second and last sections have no retention means, thereby acting as respectively intermediate wire 14 and guiding wire 17.

According to. a preferred characteristic, said guiding thread part 17 can cut through the facial tissue layers.

According to a practical embodiment of the present invention, the length of the guiding thread part 17 should be at least 10 centimeter and preferably at least 20 centimeter. According to a preferred embodiment, the guiding needle 1 is designed to pick up or to be mounted on the free extremity 15 of the guiding thread part 14.

In the most practical embodiment of the present invention, the guiding thread part 17 does not only allow guiding the thread 7 through the tissue layers but said part 17 also cuts through the periostal and subcutaneous layers, thereby positioning the thread parts 8-9 and intermediate wire 14 at the required depth, such that the intermediate wire 14 makes contact with the bone of the zygomatic arch.

The surgical device 2 and surgical thread 7 according to the invention are very easy to use as will be clear from the following explanation and from figures 4 to 9, wherein parts underneath the skin are represented in dotted lines for the sake of clarity.

After application of local anesthesia to the patient, the surgery starts with inserting the needle 4 through the skin, whereby the sharp tip 5 is used to puncture the skin in an entry point 19 situated in the vicinity of the zygomatic arch 20, as shown in figure 4.

The needle 4 is guided through the tissue layers in such a way that it passes behind the zygomatic arch 20 and that it exits the skin in an exit point 21 situated near the naso^¬ labial fold, as illustrated in figure 5.

In a second step, shown in figure 6, the free extremity 18 of the guiding wire part 17 is connected to the needle 4 and by pulling back the needle 4, the thread 7 is pulled cranially through the tissue layers and behind the zygomatic arch 20. The needle 1, still holding the extremity 18 of the thread 7, is not completely retracted but preferably remains beneath the skin inside the entry puncture point 19.

By moving the needle 4, which holds the guiding wire part 17, up and down between the entry to the exit point of the needle, the guiding wire part 17 performs a cutting action through the subcutaneous and periostal layers.

After this step, the needle 4 is retracted towards the zygomatic arch 20 but remains under the skin and the point 5 of the needle 4 is guided from underneath the zygomatic arch 20 to the outer side of the zygomatic arch 20, by passing above and over the zygomatic arch 20, and the needle 4 is pushed towards the naso-labial fold by moving the holder 3, whereby the thread 7 is guided into the facial tissue layers.

By pushing the needle 1, the thread part 8 with the removable cover 13 is pulled into the deeper tissue layers whereas the other thread part 9 is pushed through the more superficial tissue layers whereby the intermediate wire 14 circumvents a portion of the zygomatic arch 20, as shown in figure 7. Preferably, the needle 1 exits in the region of the nasolabial fold in a third point 22, coincident with or in the vicinity of the first entry point 19, such that the two extremities 18,23 of the surgical thread 7 are above the skin and such that also the protective cover 13 partly protrudes from the skin.

The extremity 18 of the thread 7 can be uncoupled from the needle 1 and the needle 1 can be removed by moving the point 5 of the needle 1 back into the direction of the zygomatic arch 20.

From the foregoing it is clear that the presence of the cover means 13 allows to pull the thread part 8 through the tissue layers without causing damage to the tissue layers or to the thread, although this thread part 8 is pulled through the tissue in a direction contrary of the effective functioning direction of the retention means 11.

It is clear that after moving the thread 7 over the zygomatic arch 20 such that the intermediate wire 14 surrounds partly the zygomatic arch 20, the intermediate wire 14 contacts the bone of the zygomatic arch 20, such that a skeletal anchorage of the surgical thread 7 is achieved . Once the thread 7 is placed into its desired position, the protective tube 13 can be removed, as shown in figure 8, and in a final step the free ends 18-23 of the thread 7 and/or the guiding part 17 can be cut off. It is of course possible to place two or more threads at different levels near the naso-labial fold in order to obtain the desired lifting effect. At the time of surgery, the thread 7 is brought into appropriate position, and by pulling cranially the soft tissues of the midface and at the same time, stabilizing both ends of the wire, traction can be applied by exteriorizing one or several retention elements 12, as illustrated by the arrows in figure 9.

In this way, the tissue is prevented from sliding off the thread part in a direction opposite to the effective direction of the retention means 11, whereas during surgery the surgeon can easily move the tissue layer over the thread part in the other direction.

The thread parts 8-9 can be cut off at their respective extremities and due to the tension on the facial tissues themselves, the last retention element 12 will disappear under the skin.

It is also possible that these free extremities are not cut at the time of surgery but a few days later so as to perform final adjustments.

From the following it is clear that after surgery, the intermediate wire 14 lies in contact with the bone at the level of the zygomatic arch 20 and that the retention means 11 on the thread parts 8-9 are effective along a vector directed from the intermediate wire 14 towards the extremity of the thread part 8-9 concerned.

It should be noted that, if necessary, the surgical thread 1 can be removed via a small intra-oral incision by pulling on the intermediate wire 14.

It is clear to the person skilled in the art that the presence of the surgical thread 7 around the zygomatic arch 20 will result in longer lasting results due to a firm anchorage of the surgical thread 7 to the facial skeleton and the creation of an internal scar between subcutaneous layers, the superficial muscular aponeurotic system (smas) and periostal layers.

Although in the foregoing method, the needle 1 is guided around the zygomatic arch 20 from the deep tissue layers to the superficial layers, it is also possible to guide the needle 1 first through the superficial layers followed by guiding the needle 1 through the deep tissue layers.

Moreover, although in the foregoing method, a needle 1 was used to guide the surgical thread 5 around the zygomatic arch 20, it is also possible to provide an embodiment of surgical thread wherein the additional part 17 is made sufficiently rigid such that this part can function as guiding needle and that no separate needle is necessary during surgery. Although not represented in the figures, the surgical device 2 according to the present invention is not only suitable for facial lifting or midface lifting but can also be used for lifting other soft tissues. Furthermore the surgical device can be adapted so as to be used for neck lifting, for facial laxity or other functional reasons in the face.

The same principle of suspending and lifting soft tissues by the surgical thread according to the invention can be applied in other parts of the human body outside the face, including but not limited to the buttocks and the breast.

Other indications for using the surgical thread according to the invention could be e.g. gynaecologic problems, pelvic floor weakness, treatments of hernia and other musculo-skeletal problems.

The firm anchorage of the surgical thread can take place on the skeleton but also on for example tendons, the fascia, muscle insertions or origins, ligaments or other firm tissues.

In general, the surgical thread according to the invention lifts and suspends soft tissues, whereby the threaded parts are guided through the tissue layers to be lifted, whereas the intermediate part is guided around or to any firm structure in the human body, such as a tendon, a bone or the fascia or the like.

It is clear that in these cases the dimensions and sizes as mentioned in the foregoing example do not necessarily apply but should be chosen as a function of the particular surgery to be carried out.

Although the surgical thread is designed to be suitable for closed surgery wherein no skin incisions should be made, it is of course possible to apply said thread in open surgery. Such technique can be preferable when an excess of skin has to be removed as well. Although not illustrated in the above-mentioned example, it is possible to use the surgical thread according to the invention for face lifting, neck lifting or other lifting surgery without using the specific needle as described above. In such alternative embodiment of the present invention, the additional guiding wire part of the surgical thread can take this function.

The present invention is in no way limited to the form of embodiment represented in the figures and described by way of example, however such surgical thread and surgical device according to the invention can be realized in different forms, shapes and dimensions, without leaving the scope of the invention.

Claims

Claims .

1. - Surgical thread (7) for lifting and suspension of soft tissues, characterized in that the thread (7) comprises two thread parts (8-9), both thread parts (8-9) being formed as a wire with retention means (11) for lifting facial tissues and being separated by means of an intermediate wire (14), the retention means (11) being effective in a single direction directed from one extremity of the thread part (8-9) towards the intermediate wire (14).

2. - Surgical thread (7) according to claim 1, characterized in that the retention means (11) comprise a series of retention elements (12) in the shape of hooks, cones, barbs or the like oriented in the same direction.

3. - Surgical thread (7) according to claim 2, characterized in that the retention elements (12) are provided at regular distances from each other.

4. - Surgical thread (7) according to any one of the preceding claims, characterized in that the intermediate wire (14) is made of a non-resorbable and supple material.

5. - Surgical thread (7) according to any one of the preceding claims, characterized in that the wires of the thread parts (8-9) and the intermediate wire (14) are formed as a single, continuous wire.

6.- Surgical thread (7) according to any one of the preceding claims, characterized in that the thread (7) is made of a non-resorbable and supple material.

7.- Surgical thread (7) according to any one of the preceding claims, characterized in that intermediate wire (14) has no retention means (11).

8. - Surgical thread (7) according to any one of the preceding claims, characterized in that the thread (7) is provided with removable covering means (13) to temporarily cover the retention means (11) of a thread part (8).

9. - Surgical thread (7) according to claim 8, characterized in that the covering means (13) consist of cylindrical silicon tube provided around the thread part (8-9) or a trocar .

10. - Surgical thread (7) according to any one of the preceding claims, characterized in that at least one of the thread parts (8-9) is extended by an additional thread part (17) without retention means (11), which additional part (17) comprises a wire which can cut through facial tissue layers .

11. - Surgical thread (7) according to any one of the preceding claims, characterized in that the thread (7) is suitable for passing behind the zygomatic arch (20) .

12.- Surgical thread (7) according to any one of the preceding claims, characterized in that the length of each thread part (8-9) is sufficient to reach from the zygomatic arch (20) to any facial tissue to be lifted.

13.- Surgical thread (7) according to any one of the preceding claims, characterized in that the length of each thread part (8-9) is at least 8 centimeter and that the length of the intermediate wire (14) is situated between 1 and 8 centimeter.

14.- Surgical thread (7) according to any one of the preceding claims, characterized in that the thread parts (8-9) are suitable for cooperating with different layers of tissue .

15.- Surgical thread (7) according to any one of the preceding claims, characterized in that the length of the intermediate wire (14) is longer than half the circumference of the cross section of the zygomatic arch (20); so that when the thread (5) is placed over the zygomatic arch (20) with the intermediate wire (14) surrounding the zygomatic arch (20), the intermediate wire (14) contacts the bone of the zygomatic arch (20) and provides a skeletal anchorage of the surgical thread (7).

16.- Surgical device (2) for lifting and suspension of soft tissues, characterized in that it comprises at least a surgical thread (7) according to any of the preceding claims 1 to 15 and a needle (1) for introducing the thread (7) into the soft tissue by moving and guiding the thread (7) by means of the needle (1) and that the thread (7) is provided with removable cover means (13) to temporarily cover the retention means (11) of one thread part (8) for moving the thread (7) through the soft tissue in a direction opposite to the effective single direction of the concerned thread part (8).