WO2018127907A1

WO2018127907A1 - Surgical thread for plastic surgery

Info

Publication number: WO2018127907A1
Application number: PCT/IL2018/050002
Authority: WO
Inventors: Ran TALISMAN
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-01-03
Filing date: 2018-01-01
Publication date: 2018-07-12
Anticipated expiration: 2019-07-03

Abstract

A tissue lagging device for plastic surgery, including a biocompatible and bio-absorbable hollow sleeve configured for implantation into the tissue between an entrance and an exit point of said tissue; a biocompatible and bio-absorbable thread; and a tissue ingrowth member attached to a distal end of the thread, the tissue ingrowth member configured for tissue ingrowth; such that when the thread is pulled, tissue associated with the tissue ingrowth member is lifted and/or lagged towards solid tissue.

Description

SURGICAL THREAD FOR PLASTIC SURGERY

TECHNOLOGICAL FIELD

This invention relates to surgical devices for pulling a soft tissue. More particularly, to thread based devices for lifting and or lagging tissue, for example, facial tissue, during plastic surgery.

BACKGROUND

Surgical threads used in the procedural aesthetic field are well known. The threads all have the following characteristics: minimal skin cut for insertion (usually a needle prick), durability (as much as the material and the diameter allows), the actual threads are usually in one direction but can be multi-directional and have variable lengths. The logic behind using a thread varies and depends on the nature of the threads. Single straight threads, with or without inherent spring effect, such as cogs, are based on the rationale that insertion of a thread into the sub-cutis causes collagen to form around and tighten the tissue, which improves its appearance. Double armed needle threads (e.g. Silouhtte™), with or without spring effect, generally rely on a tissue pulling effect, which are based on the rationale that insertion of a thread into the sub- cutis plane from the relatively non-mobile tissue into mobile tissue will bring about immediate pulling of the mobile tissue and fixation after the move using the threads as anchoring aids. As a secondary effect, collagen is built up around the thread/tissue which tightens it to enhance the effect.

Most of the threads are relatively simple to insert and have an immediate pulling effect that usually has mechanical grip with a load that can pull the tissue up to a certain extent.

The first recognizable invention that incorporated the idea of a one-way suture was patented in 1964 by the physician JH Alcamo, MD, and was directed to a suture with a "roughened" surface that offered resistance in only one direction. It was designed to be used in a surgical sewing machine, but no implementation of the suture has been reported. The next, and probably most significant, patent did not come until 1994. Gregory L. Ruff, MD, formerly an assistant professor of plastic surgery at Duke University (Durham, NC), described not only a unidirectional barbed suture, but also a hollow insertion device for placement. Many subsequent patents, including one of Ruff's, have demonstrated the evolution of this device to a barbed suture that does not require a separate insertion device, but instead has needles on each end. One needle is used for positioning the suture, and the other is used for anchoring it to deeper structures. When placed correctly, the barbed suture lifts 1 pound per inch of its length. This was the first, and, as of this writing, the only barbed suture to achieve US Food and Drug Administration (FDA) certification.

A thread that was developed in Russia has been widely used internationally, but it has not yet been cleared by the FDA. It is a bidirectional, free-floating thread that is placed through a hollow needle. After the needle is placed, the tissues are compressed over the needle, which is then withdrawn, causing the cogs to engage the tissues and support them. Theoretically this enables rapid placement of the threads. The disadvantages, which are related to the thread's free-floating nature, include more frequent migration with exposure, reduced duration of the effect, and sometimes inappropriate bunching of the tissues being lifted. Another thread developed by Woffles Wu, MD, in Singapore is a long bidirectional suture, with cogs converging toward a central 8-cm non-barbed section. It is inserted through a long hollow needle and turned; the second half is reinserted roughly parallel to the first half. The long non-barbed section in the middle is the point of maximum lift, and it can again act like a cheese wire. This suture can be difficult to place because of its length and its tendency to act like two barbed anchors with a cheese- wire suture in the center. Once the upside-down loop is placed and the barbed ends are pulled, there is no further tissue positioning.

The main drawback of the currently known threads is the "Swiss cheese" effect. In other words, the threads cut through the tissue instead of pulling/lifting it. The lifting effect in currently used threads is typically only due to secondary collagen formation.

There is thus a need in the art for new thread based surgical devices that will provide better lifting results. SUMMARY

The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

There is provided herein, according to some embodiments, a device and method for pulling a moveable soft tissue towards a solid soft tissue, for example, for lifting of the soft tissue.

Advantageously, the device disclosed herein, which may also be referred to as TSALT™ according to some embodiments, is designed to create an optimal, optionally plastic no n- surgical thread configured to provide maximal lagging between stable and moveable soft tissue in the face, body and extremities by allowing tissue ingrowth around and into the suture, for example by using the herein disclosed tissue compatibility and locking mechanism.

Advantageously, allowing tissue ingrowth into the sliding part of the thread before the pulling act, the TSALT™ provides maximum tissue bonding between the thread and the moving tissue. Furthermore, due to the lagging, maximal compression or pulling between stable tissue and moving tissue is achieved.

There is provided herein, according to some embodiments, a medical device for plastic surgery. The device includes a thread and a tissue ingrowth element located at or associated with a distal section of the thread. The tissue ingrowth element, such as a biocompatible net or mesh, is configured to allow soft tissue growth therein. The device optionally further includes a pulling element (such as, but not limited to, a ring) at or associated with a proximal section of the thread. The pulling element is configured to allow efficient pulling of the thread, thus allowing pulling/lifting of soft tissue associated with the tissue ingrowth element, towards a stable tissue.

More details and features of the current invention and its embodiments may be found in the description and the attached drawings.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

According to some embodiments, there is provided a tissue lagging device for plastic surgery, the device comprising a biocompatible and bio -absorbable hollow sleeve forming an open-ended lumen, the lumen having a proximal end and a distal end; wherein the sleeve is configured for implantation into the tissue between an entrance and an exit point of the tissue; a biocompatible and bio-absorbable thread slidingly extending along a length of the lumen; wherein a proximal end of the thread extends out of the sleeve's proximal end; a tissue ingrowth member attached to a distal end of the thread, the tissue ingrowth member configured for tissue ingrowth; and a locking mechanism configured to lock the thread within the sleeve, such that when the thread is pulled and tissue associated with the tissue ingrowth member is lifted, distal movement of the tissue ingrowth member is prevented.

According to some embodiments, the device further comprises a tissue piercing member having a sharp distal end, said tissue piercing member being detachably connected to said sleeve's distal end and configured to penetrate the tissue at the entrance point and to allow passage of the device until exiting the exit point.

According to some embodiments, the tissue piercing member is a trocar having a shape of a smooth cone.

According to some embodiments, the locking mechanism comprises an anchoring element positioned on a part of the thread positioned within the hollow sleeve, proximally to the tissue ingrowth member, and an anchoring site formed in an inner wall of the sleeve's proximal end, the anchoring site configured to secure the anchoring element, thereby preventing distal movement of the thread and the tissue ingrowth member.

According to some embodiments, the anchoring element comprises one or more unidirectional absorbable cones and the anchoring site comprises one or more rails/shelves configured to secure the cones therein. According to some embodiments, the sleeve comprises a stopper attached to the sleeve's proximal end, the stopper configured to abut the entrance point, thereby preventing the sleeve from moving distally, toward/through the exit point.

According to some embodiments, the stopper is detachable from the sleeve.

According to some embodiments, the device further comprises a pulling member attached to the thread's proximal end, wherein the pulling member is configured to allow a user to pull the thread proximally, thereby causing a lifting of tissue and/or lagging associated with the tissue ingrowth member.

According to some embodiments, the device further comprises one or more wings, wherein the one or more wings are configured to anchor the sleeve to surrounding tissue. According to some embodiments, the one or more wings are positioned on an outer surface of the sleeve's proximal end.

According to some embodiments, the tissue ingrowth member is a net.

According to some embodiments, there is provided a method for lagging tissue in a plastic surgery of a subject, the method comprising: inserting a tissue lagging device into a target tissue, wherein the tissue lagging device comprises: a biocompatible and bio -absorbable hollow sleeve forming an open-ended lumen, the lumen having a proximal end and a distal end; a biocompatible and bio-absorbable thread slidingly extending along a length of the lumen; wherein a proximal end of the thread extends out of the sleeve's proximal end; a tissue ingrowth member attached to a distal end of the thread, the tissue ingrowth member configured for tissue ingrowth; and a locking mechanism positioned on a part of the thread positioned within the hollow sleeve, proximally to the tissue ingrowth member, and wherein the inserting comprises penetrating the subject's skin at an entrance point, passing the device through the tissue until an exit point in the subject's skin is reached and penetrating the exit point; pulling the thread proximally, thereby causing tissue associated with the tissue ingrowth member to be lifted and lagged towards the entrance point, wherein the pulling is performed following a wait period, which wait period allows tissue ingrowth into the tissue ingrowth member; and locking the thread within the sleeve, thereby preventing distal movement of the tissue ingrowth member.

According to some embodiments, the inserting further comprises passing the device through the tissue until a stopper abuts the entrance point, thereby positioning the sleeve within the tissue, between the entrance and exit points.

According to some embodiments, the penetrating of the subject's skin at the entrance and exit points is performed using a tissue piercing element attached to a distal end of the hollow sleeve.

According to some embodiments, the method further comprises detaching the tissue piercing element from the sleeve following the penetration of the exit point.

According to some embodiments, the pulling is performed using a pulling member attached to the thread's proximal end.

According to some embodiments, the locking comprises anchoring an anchoring element, positioned on a part of the thread located within the hollow sleeve, proximally to the tissue ingrowth member, to an anchoring site formed in an inner wall of the sleeve's proximal end.

According to some embodiments, the anchoring element comprises one or more unidirectional absorbable cones, and wherein the anchoring site comprises one or more stopper shelves configured to secure the one or more cones therein.

According to some embodiments, the method further comprises further comprising detaching the stopper and/or the pull member from the sleeve. BRIEF DESCRIPTION OF THE DRAWING

Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive. The figures are listed below:

Figure 1 schematically depicts a surgical device, according to an exemplary embodiment of the current invention;

Figure 2 schematically depicts the surgical device of Figure 1 in a first operation position, according to an exemplary embodiment of the current invention;

Figure 3 schematically depicts a surgical device of Figure 1 in a second operation position, according to an exemplary embodiment of the current invention; and

Figure 4 schematically depicts a surgical device of Figure 1 in a third operation position, according to an exemplary embodiment of the current invention.

DETAILED DESCRIPTION

While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced be interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

According to some embodiments, there is provided a tissue lifting and/or tissue lagging device including a biocompatible and bio-absorbable hollow sleeve forming an open-ended lumen, the lumen having a proximal end and a distal end; a bioimplantable thread slidingly extending along a length of the lumen; and a tissue ingrowth member attached to a distal end of the thread, the tissue ingrowth member configured to promote tissue ingrowth.

According to some embodiments, the sleeve is configured for implantation into the tissue between an entrance and an exit point of a subject's skin. According to some embodiments, the sleeve may be made of any flexible, biocompatible and bio- absorbable material, such as, but not limited to, purified collagen (e.g. bovine collagen), polyglycolic acid (optionally coated with N-laurin and L-lysine), polyester, poly (p- dioxanone), glycolide, 1-lactide, p-dioxanone, trimethylene carbonate and ε- caprolactone or any combination thereof.

According to some embodiments, the sleeve lumen may have a diameter in the range of 0.5 mm-5mm, lmm-4.5mm, 1.5mm-4.5mm, 1.5mm-3.5 mm or any other suitable diameter range within the range of 0.5mm-5mm. Each possibility is a separate embodiment. According to some embodiments, the sleeve is configured for implantation and remains embedded in the tissue until absorbed.

According to some embodiments, a thread (also referred to as a suture) may be made of any flexible, biocompatible and bio-absorbable material capable of withstanding a persistent pull force, such as, but not limited to, purified collagen (e.g. bovine collagen), polyglycolic acid (optionally coated with N-laurin and L-lysine), polyester, poly (p-dioxanone), glycolide, 1-lactide, p-dioxanone, trimethylene carbonate and ε-caprolactone or any combination thereof. Each possibility is a separate embodiment. According to some embodiments, the thread may have tensile retention for at least 5 days, at least 7 days, at least 10 days or at least 14 days. Each possibility is a separate embodiment. According to some embodiments, the proximal end of the thread extends out of the sleeve's proximal end. According to some embodiments, the thread may be a multifilament thread. According to some embodiments, the thread may be braided. Additionally or alternatively, the distal end of the thread extends out of the sleeve's distal end.

As used herein, the term "absorbable", with referral for example to the thread and/or the sleeve, refers to the ability of the thread/sleeve to be degraded/disintegrated naturally by the body, without leaving foreign material requiring further procedure. Without being bound by any theory, the thread/sleeve may be absorbed by any of a various of processes including hydrolysis (polyglycolic acid), and proteolytic enzymatic degradation. According to some embodiments, the thread and/or the sleeve may be absorbed within ten days to eight weeks, thus allowing healing of the tissue prior to being absorbed.

As used herein, the term "biocompatible", with referral for example to the thread and/or the sleeve, refers to the capability of the thread/sleeve to exist in harmony with tissue without causing deleterious changes.

As used herein, the term "tissue ingrowth member" may refer to any suitable, biocompatible and bio -absorbable material configured to promote tissue growth therein, such as, but not limited to, purified collagen (e.g. bovine collagen), polyglycolic acid (optionally coated with N-laurin and L-lysine), polyester, poly (p- dioxanone), glycolide, 1-lactide, p-dioxanone, trimethylene carbonate and ε- caprolactone or any combination thereof. Non-limiting examples of tissue ingrowth members include tissue growth promoting meshes and/or nets. According to some embodiments, the tissue ingrowth member is attached to a distal end of the thread.

According to some embodiments, pulling of the thread, for example by grasping a pulling member, causes backward movement of the tissue ingrowth member towards the sleeves proximal end. According to some embodiments, the pulling member may be any member, having any suitable shape, allowing convenient grasping and pulling of the thread. A non-limiting example of a suitable pulling member includes a ring attached to the thread's proximal end.

According to some embodiments, the device further includes a locking mechanism configured to lock and/or immobilize the thread within the sleeve lumen, thereby preventing distal movement thereof. Without being bound by any theory, this may ensure that the tissue associated with the tissue ingrowth member will be lagged to the tissue, towards which it is pulled. According to some embodiments, the locking mechanism may include an anchoring element and an anchoring site. According to some embodiments, the anchoring element may be positioned on the part of the thread positioned within the hollow sleeve, proximally to the tissue ingrowth member. According to some embodiments, the anchoring site may be formed in an inner wall of the sleeve's proximal end. According to some embodiments, the anchoring site is configured to secure/fasten/lock the anchoring element, thereby preventing distal movement of the thread and thus of the tissue ingrowth member. According to some embodiments, the anchoring element may include one or more unidirectional absorbable cones, and the anchoring site may include one or more rails/shelves configured to secure/lock/engage therein the cones.

As used herein, the term "lagging" refers to compression of one tissue to another tissue, specifically, to pulling and securing moveable soft tissue associated with the tissue ingrowth member of the device to the stable tissue.

According to some embodiments, the device includes a tissue piercing member having a sharp distal end. According to some embodiments, the tissue piercing element may be a trocar. According to some embodiments, the trocar may be shaped as a smooth cone, optionally made of metal. According to some embodiments, the tissue piercing member may be detachably connected to the sleeve's and/or thread's distal end. According to some embodiments, the tissue piercing member may be configured to penetrate the subject's skin at the entrance point (e.g. beneath the subject's cheek bone) and to allow passage of the device until exiting the skin at an exit point (e.g. in the area of the lower check).

According to some embodiments, the sleeve includes a stopper at its proximal end, the stopper being configured to prevent the sleeve from moving distally, toward the exit point, when the stopper abuts the entrance point. According to some embodiments, the stopper may have any number of configurations, capable of enlarging the sleeve' s outer circumference or otherwise preventing the sleeve from sliding distally beyond the entrance point. As a non-limiting example, the stopper may be ring-shaped so as to circumferentially engage an outer surface of the sleeve's proximal end. As another non-limiting example, the stopper may include a plurality of elements circumferentially spaced apart around the outer surface of the sleeve's proximal end. According to some embodiments, the stopper is detachable from the sleeve. This advantageously allows removing the stopper at the end of the procedure, as further described herein.

According to some embodiments, the device includes a pulling member attached to the thread's proximal end. The pulling member is configured to allow a user to pull the thread proximally (i.e. in direction of the entrance point), thereby causing a lifting/lagging of the tissue associated with the tissue ingrowth member. According to some embodiments, the pulling member may be a pulling ring, however other configurations allowing physicians (or other users) to efficiently grasp and pull the thread are also applicable and within the scope of this disclosure.

According to some embodiments, the device includes further one or more wings, hooks, prongs or other suitable element configured to anchor the sleeve to surrounding tissue. According to some embodiments, the wings, hooks, prongs or other suitable element are positioned on an outer surface of the sleeve's proximal end.

According to some embodiments, there is provided a method for tissue lagging for plastic surgery, the method comprising: inserting a tissue lagging device into a target tissue, wherein the device includes a biocompatible and bio-absorbable hollow sleeve forming an open-ended lumen, the lumen having a proximal end and a distal end; a biocompatible thread slidingly extending along a length of the lumen; wherein a proximal end of the thread extends out of the sleeve's proximal end; a tissue ingrowth member attached to a distal end of the thread, the tissue ingrowth member configured for tissue ingrowth; and a locking mechanism positioned on a part of the thread positioned within the hollow sleeve, proximally to the tissue ingrowth member; and pulling the thread proximally, thereby causing tissue associated with the tissue ingrowth member to be lifted towards the entrance point. The pulling is preferably performed following a lag period, which lag period allows tissue ingrowth into the tissue ingrowth member; and locking the tread within the sleeve, thereby preventing distal movement of the tissue ingrowth member.

According to some embodiments, inserting the tissue lagging device comprises penetrating the subject's skin at an entrance point using a tissue piercing element (such as, but not limited to, a trocar attached to the sleeve's distal end), passing the device through the tissue until an exit point in the subject's skin is reached and penetrating the exit point using the tissue piercing element. According to some embodiments, inserting the tissue lagging device further comprises passing the device through the tissue until a stopper abuts the entrance point, thereby positioning the sleeve within the tissue, between the entrance and exit points.

According to some embodiments, the method further comprises detaching the tissue piercing element from the sleeve, after the penetration of the skin at the exit point.

According to some embodiments, the pulling may be performed using a pulling member (such as, but not limited to, a pulling ring), attached to the thread's proximal end.

According to some embodiments, the locking comprises anchoring an anchoring element, positioned on a part of the thread located within the hollow sleeve, proximally to the tissue ingrowth member, to an anchoring site, the anchoring site formed in an inner wall of the sleeve's proximal end. According to some embodiments, the anchoring element may include one or more unidirectional absorbable cones, and the anchoring site may include one or more rails configured to secure the one or more cones therein.

According to some embodiments, the method further comprises detaching the stopper and/or the pull member from the sleeve after the locking of the tread within the sleeve.

Reference is now made to Figures 1-4, which schematically depict a surgical device 150, according to an exemplary embodiment of the current invention, in its various configurations.

The following numbers represent exemplary elements:

The number 10 depicts a sharp end of a trocar 20 that allows penetration of a subject's skin at an entrance point (not shown) and provides easy and smooth passage of device 150 through the tissue until penetrating an exit point in the subject's skin (not shown).

The number 20 depicts a trocar body being a smooth cone that is hooked to a distal end of a sleeve 70. Once penetrating the skin at the exit point, trocar 20 is preferably detached from sleeve 70. The number 30 depicts a tissue ingrowth member, here a net configured to promote tissue ingrowth into and around tissue ingrowth member 30 for maximal adhesion before pulling and lagging. Tissue ingrowth member 30 is attached/connected to a thread 40.

The number 40 depicts an absorbable thread, attached at its distal end to tissue ingrowth member 30. The proximal end of thread 40 may include a locking member, such as the herein depicted unidirectional absorbable cones 50.

The number 50 depicts a locking member, here a locking member including absorbable unidirectional cones, configured to engage an absorbable locking site 60.

The number 60 depicts a locking site, here a locking site including an absorbable shelf/shelves that allows locking of locking member 50 once they are pulled through the shelf, thereby enabling the lagging of the tissue associated with tissue ingrowth member 30.

The number 70 depicts the absorbable hollow sleeve holding therein thread 40 and tissue ingrowth member 30.

The number 80 depicts a stopper ring, attached to the proximal end of sleeve 70. Stopper ring 80 is configured to prevent sleeve 70 from moving distally off the entrance point and thus to reinforce/augment the lagging process.

The number 90 depicts a proximal part of absorbable thread 30 extending outside the proximal end of sleeve 70. Proximal end 90 includes a pulling ring 100 configured to assist the surgeon in grasping and pulling thread 40.

The number 100 depicts the pulling ring that helps to pull the thread and to lock it once the engagement between locking member 50 and locking site 60 is achieved.

The number 110 depicts an optional element of absorbable wings/hooks which are positioned on an outer surface of hollow sleeve 70. Wings/hooks 110 are configured to allow solid anchoring of the sleeve's proximal end to soft tissue surrounding it. Device 150 shows an exemplary embodiment of the hereindisclosed absorbable surgical device that aims to achieve a maximal soft tissue pulling effect in a minimally invasive nonsurgical procedure using a unique lagging mechanism. The device may be implanted in a procedure requiring initial pre-procedural marking, and administration of local anesthesia, with or without nerve block.

Fig.l, depicts device 150 in its initial configuration, at which device 150 is inserted, following the initial preparation and sterilization of a target area. In this configuration, device 150 is attached to a trocar body 20 having a sharp end 10 configured for penetrating a subject's skin (not shown) at an entrance point (not shown) marked thereon. The entrance point is preferably located in an area having relatively solid tissue. Sharp end 10 and trocar body 20 assist in passing device 150 in a distal direction and through the flexible soft tissue to an exit point (not shown) likewise marked on the subject's skin. The exit point is located in the target area, lifting of which is desired. It is understood that according to some alternative embodiments, the skin may be penetrated using a separate element, followed by delivery of a device similar to device 150, but devoid of trocar body 20 (embodiment not shown).

Fig. 2, depicts device 150 in a second configuration assumed upon reaching an exit point marked on the subject's skin. Once sharp end 10 of trocar 20 penetrates through the skin, trocar body 20 is detached from the distal end of sleeve 70, while leaving tissue ingrowth 30 and sleeve 70 completely or partially embedded within the soft tissue. At the entrance point, stopper ring 80 is left outside, abutting the entrance point, thus ensuring that sleeve 70 is positioned within the tissue between the entrance and exit points. Proximal end 90 of thread 40, includes pulling ring 100, hanging unrestrained until the pulling act that is carried out after a sufficient ingrowth of tissue into tissue ingrowth member 30 has been achieved. Device 150 is left in place until the tissue ingrowth period around and/or into tissue ingrowth member 30 reaches the optimal reinforcement tissue growth. Once this period ends, ring 100 is pulled and by doing so the movable soft tissue is lifted/lagged distally towards the stable tissue (i.e. towards the entrance point).

Fig. 3 shows a third configuration of device 150 in which optionally thread 40 is pulled sufficiently for anchoring member (cones) 50 to engage anchoring site (stopper shelf) 60, thereby locking/immobilizing thread 40 within sleeve 70 and completing the lagging of the soft tissue associated with tissue ingrowth member 30 to the more solid tissue in proximity to the entrance point.

Fig. 4 shows a fourth configuration of device 150 in which stopper 80 is detached from sleeve 70 and proximal end 90 of thread 40, including pulling ring 100, is cut off to allow smooth heeling of the entrance point over the proximal section of sleeve 70. Optionally, absorbable wings 110, attached to the outer surface of sleeve 70, hooks into the surrounding tissue, thereby augmenting the anchoring of sleeve 70 to the solid tissue. Advantageously, the device provides maximal possible adherence between the absorbable device and sagging/wrinkled tissue by facilitating a real and significant lagging between moveable soft tissue and solid soft tissue, and thus provide the best lifting ability of soft tissue.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" or "comprising", when used in this specification, specify the presence of stated features, integers, steps, operations, elements, or components, but do not preclude or rule out the presence or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof. According to some embodiments, the term "comprising" may be replaced by the term "consisting essentially of" or "consisting of .

The term "about" refers to a reasonable variation from a stated amount that retains the ability to achieve one or more functional effect to substantially the same extent as the stated amount. The term may also refer herein to a value of plus or minus 10% of the stated value; or plus or minus 5%, or plus or minus 1%, or plus or minus 0.5%, or plus or minus 0.1%, or any percentage in between.

While a number of exemplifyingaspects and embodiments have been discussed above, those of skill in the art will envisage certain modifications, additions and subcombinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced be interpreted to include all such modifications, additions and sub-combinations as are within their true spirit and scope.

Claims

CLAIM

1. A tissue lagging device for plastic surgery, the device comprising:

a biocompatible and bio-absorbable hollow sleeve forming an open-ended lumen, said lumen having a proximal end and a distal end; wherein said sleeve is configured for implantation into the tissue between an entrance and an exit point of said tissue;

a biocompatible and bio-absorbable thread slidingly extending along a length of said lumen; wherein a proximal end of said thread extends out of said sleeve's proximal end;

a tissue ingrowth member attached to a distal end of said thread, said tissue ingrowth member configured for tissue ingrowth; and

a locking mechanism configured to lock said thread within said sleeve, such that when said thread is pulled and tissue associated with said tissue ingrowth member is lifted, distal movement of said tissue ingrowth member is prevented.

2. The device of claim 1, further comprising a tissue piercing member having a sharp distal end, said tissue piercing member being detachably connected to said sleeve's distal end and configured to penetrate the tissue at the entrance point and to allow passage of the device until exiting the exit point.

3. The device of claim 2, wherein said tissue piercing member is a trocar having a shape of a smooth cone.

4. The device of any of claims 1-3, wherein said locking mechanism comprises: an anchoring element positioned on a part of the thread positioned within said hollow sleeve, proximally to said tissue ingrowth member, and an anchoring site formed in an inner wall of said sleeve's proximal end, said anchoring site configured to secure said anchoring element, thereby preventing distal movement of said thread and said tissue ingrowth member.

5. The device of claim 4, wherein said anchoring element comprises one or more unidirectional absorbable cones and said anchoring site comprises one or more rails configured to secure said cones therein.

6. The device of any of claims 1-5, wherein the sleeve comprises a stopper attached to said sleeve's proximal end, said stopper configured to abut the entrance point, thereby preventing said sleeve from moving distally, toward said exit point.

7. The device of claim 6, wherein said stopper is detachable from said sleeve.

8. The device of any of claims 1-7, further comprising a pulling member attached to said thread's proximal end, wherein said pulling member is configured to allow a user to pull said thread proximally, thereby causing a lifting of tissue and/or lagging associated with said tissue ingrowth member.

9. The device of any of claims 1-8, further comprising one or more wings, wherein said one or more wings are configured to anchor said sleeve to surrounding tissue.

10. The device of claim 9, wherein said one or more wings are positioned on an outer surface of said sleeve's proximal end.

11. The device of any of claims 1-10, wherein said tissue ingrowth member is a net.

12. A method for lagging tissue in a plastic surgery of a subject, the method comprising:

inserting a tissue lagging device into a target tissue,

wherein the tissue lagging device comprises: a biocompatible and bio-absorbable hollow sleeve forming an open-ended lumen, the lumen having a proximal end and a distal end; a biocompatible and bio-absorbable thread slidingly extending along a length of the lumen; wherein a proximal end of the thread extends out of the sleeve's proximal end; a tissue ingrowth member attached to a distal end of the thread, the tissue ingrowth member configured for tissue ingrowth; and a locking mechanism positioned on a part of the thread positioned within the hollow sleeve, proximally to the tissue ingrowth member, and wherein the inserting comprises penetrating the subject's skin at an entrance point, passing the device through the tissue until an exit point in the subject's skin is reached and penetrating the exit point; pulling the thread proximally, thereby causing tissue associated with the tissue ingrowth member to be lifted and lagged towards the entrance point, wherein the pulling is performed following a wait period, which wait period allows tissue ingrowth into the tissue ingrowth member; and locking the tread within the sleeve, thereby preventing distal movement of the tissue ingrowth member.

13. The method of claim 12, wherein the inserting further comprises passing the device through the tissue until a stopper abuts the entrance point, thereby positioning the sleeve within the tissue, between the entrance and exit points.

14. The method of any of claims 12-13, wherein the penetrating of the subject's skin at the entrance and exit points is performed using a tissue piercing element attached to a distal end of the hollow sleeve.

15. The method of claim 14, further comprising detaching the tissue piercing element from the sleeve following the penetration of the exit point.

16. The method of any of claims 12-15, wherein the pulling is performed using a pulling member attached to the thread's proximal end.

17. The method of any of claims 12-16, wherein the locking comprises anchoring an anchoring element, positioned on a part of the thread located within the hollow sleeve, proximally to the tissue ingrowth member, to an anchoring site formed in an inner wall of the sleeve's proximal end.

18. The method of claim 17, wherein the anchoring element comprises one or more unidirectional absorbable cones, and wherein the anchoring site comprises one or more stopper shelves configured to secure the one or more cones therein.

19. The method of any of claims 12- 18, further comprising detaching the stopper and/or the pull member from the sleeve.