WO2016148647A1

WO2016148647A1 - Anchor and suture for a suture assembly

Info

Publication number: WO2016148647A1
Application number: PCT/SG2016/050118
Authority: WO
Inventors: Nir Ellenbogen; Hajime WATAHIKI
Original assignee: I Support Pte. Ltd.
Priority date: 2015-03-13
Filing date: 2016-03-14
Publication date: 2016-09-22

Abstract

An anchor (80) for a suture assembly, the anchor comprising: a rigid portion (88) having a leading end; a suture engager (89) configured to engage a central portion of a length of suture at a distance from the leading end; and at least two resilient portions (84) projecting laterally from the rigid portion, the at least two resilient portions configured to be displaceable towards a central longitudinal axis (L) of the anchor. A suture assembly, the suture comprising: a single length of suture; a first barbed portion having a first plurality of barbs formed thereon; a second barbed portion having a second plurality of barbs formed thereon, wherein the first plurality of barbs and second plurality of barbs are inclined towards a central portion of the length of suture.

Description

ANCHOR AND SUTURE FOR A SUTURE ASSEMBLY

Field

The present invention relates to an anchor and a suture for a suture assembly for cosmetic enhancement.

Background

Many devices and methods have been developed over the years for face lift procedures, with the aim to minimise the wounding, scarring and tissue dissection caused by these procedures. One such device is the barbed suture.

Typically, each suture is stitched through the tissue with a needle, with the barbs oriented away from the needle, in a direction opposite the thread tension. After a number of sutures are inserted in appropriate locations, the facial tissue may then be lifted manually and the barbs would hold the tissue in place in the new configuration. The tension on the thread is then readjusted and the thread secured at a final position with knots. The thread is then cut flush to the knot and urged under the skin.

Generally, some or all of these prior art methods may result in at least two entry/exit wounds per suture, may be subject to single sutures breaking, multiple entry and exit points, each entry and exit point causing scarring and bleeding, significant anaesthetic may be required, and/or the recovery time may be significant.

Summary

In general terms, the present invention proposes a minimally invasive device and technique for cosmetic suturing.

According to a first aspect, there is provided an anchor for a suture assembly, the anchor comprising: a rigid portion having a leading end; a suture engager configured to engage a central portion of a length of suture at a distance from the leading end; and at least two resilient portions projecting laterally from the rigid portion, the at least two resilient portions configured to be displaceable towards a central longitudinal axis of the anchor to allow passage of the anchor through a cannula during implantation of the suture assembly in a patient, the at least two resilient portions further configured to return to their undisplaced positions once the anchor exits the cannula in order to engage facial tissue of the patient to resist movement of the anchor after the anchor is implanted in the patient. The suture engager may comprise a narrowed neck provided within the rigid portion at a distance from the leading end, the narrowed neck configured to engage an enlarged portion of the central portion of the length of suture, the narrowed neck and the leading end defining a space within the rigid portion for containing at least a majority of volume of the enlarged portion within the rigid portion.

The narrowed neck may comprise an opening configured to allow passage of two portions of suture therethrough and to prevent passage of the enlarged portion therethrough.

The opening may be elongate in a plane perpendicular to the central longitudinal axis of the anchor.

The space may be configured to fully contain the volume of the enlarged portion therein.

The enlarged portion may comprise one of: a knot of the suture and a bead secured to the suture.

The suture engager may comprise a channel extending across the leading end into the rigid portion.

The channel may be configured to engage the central portion of the length of suture via a press fit.

The rigid portion may comprise a groove on each side of the rigid portion, each groove extending longitudinally down each side of the rigid portion

According to a second aspect, there is provided a suture for a suture assembly, the suture comprising: a single length of suture; a first barbed portion having a first plurality of barbs formed thereon; and a second barbed portion having a second plurality of barbs formed thereon, wherein the first plurality of barbs and the second plurality of barbs are inclined towards a central portion of the length of suture.

The suture may have a knot tied at the central portion of the length of suture. The knot may comprise an overhand knot.

Prior to assembly of the suture with an anchor of the suture assembly, the first barbed portion may be on a first side of the knot and the second barbed portion may be on a second side of the knot, and wherein at the time of assembly of the suture with the anchor, the first barbed portion and the second barbed portion may be generally alongside each other on a same side of the knot.

According to a third aspect, there is provided a suture assembly comprising the anchor of the first aspect and the suture of the second aspect.

One or more of these aspects may have one or more of the following additional advantages:

• less skill required for procedure,

• less training time for the practitioner,

• less qualified practitioner may be required for procedure,

• barbs are smaller and more effective,

• less invasive,

• shorter procedure,

• less puncture and insertion wounds,

• less bleeding,

• less chance of infection or complications,

• more distributed and increased lifting force,

• high tensile strength of the suture,

• shorter recovery time,

• less anaesthetic required,

• more tension able to be applied,

• less chance of failures during implanting as less tension than needle drawing,

• less chance of early failures during normal lifetime,

• lower chance of error in positioning and insertion of the suture,

• faster scar healing,

• less residual scar tissue,

• less noticeable scar location,

• no external knot, loop or anchor, and/or

• previously unreachable tissue can be lifted.

Brief Description of Drawings

Exemplary embodiments of the invention will now be described, with reference to the following figures:

FIG. 1 is a front view of a patient's facial tissue implanted with a plurality of suture assemblies of the present invention. FIG. 2 is a schematic illustration of a first embodiment of a suture of a first embodiment of a suture assembly prior to assembly.

FIG. 3 is a schematic illustration of the first embodiment of the suture assembly prior to complete assembly.

FIG. 4 shows various views of the suture assembly of FIG. 3 completely assembled for implantation in a patient.

FIG. 5 shows various views of an anchor of the suture assembly of FIG. 4.

FIG. 6 shows various views of a second embodiment of the suture assembly.

FIG. 7 shows various views of an anchor of the suture assembly of FIG. 6.

Detailed Description

Embodiments of an anchor 80, a suture 90 and a suture assembly 100 will be described with reference to FIGS. 1 to 7, wherein the same reference numerals have been used to indicate the same or similar parts.

Referring to FIG. 1 , the suture assembly 100 is designed to effect a distributed lifting force to desired portions of facial tissue of a patient whose face may be subject to rhytides (wrinkles) or ptosis (sagging). The suture assembly 100 may be used to lift tissue in the cheeks 102, temples 104, neck or forehead 106 zones. In each zone, one or more barbed sutures are upwardly implanted within or under the tissue. An entry site 108 of the suture assembly 100 is below a final implantation position 112 of an anchor 80 of the suture assembly 100 when the patient is in an upright position, there being no exit site of the suture assembly 100 during implantation. The suture assembly 100 may reduce the number of wounds significantly compared to known methods, and the practitioner is able to provide lift in any location, as there is no need to provide an exit site at an unobtrusive location. Each entry site 108 may include more than one implanted suture, for example three implanted suture assemblies 110 at different angles. Each suture assembly 110 may include a single or multiple sutures, which are anchored at the top 112.

For all embodiments, the anchor 80 is configured to anchor the suture 90 in place to provide a necessary reaction force to lifting forces provided by the barbs 911 , 922 to the facial tissue. The anchor 80 is also configured to allow the suture assembly 100 to be pushed into a cannula (not shown) provided for implantation of the suture assembly 100 in the patient.

As shown in FIG. 2A (not to scale), a suture 90 of a first embodiment of the suture assembly 100 comprises a single length of suture 90 having a knot 99 tied at a central portion 98 of the length of the suture 90. The suture 90 has a first barbed portion 91 having a first plurality of barbs 911 formed thereon, and a second barbed portion 92 having a second plurality of barbs 922 formed thereon. The first plurality of barbs 911 and the second plurality of barbs 922 are inclined towards the knot 99, and are preferably provided on the first and second barbed portions 91 , 92 in a staggered and opposite-sided distribution, as depicted. Preferably, the knot

99 comprises an overhand knot so as to be as small and simple a knot as possible. Prior to assembly with the anchor 80 to form the suture assembly 100, the first barbed portion 91 and the second barbed portion 92 may be on different sides of the knot 99, as shown in FIG. 2A.

As shown in FIG. 2B (not to scale), a suture 90 of a second embodiment of the suture assembly

100 comprises a single length of suture 90. The suture 90 has a first barbed portion 91 having a first plurality of barbs 911 formed thereon, and a second barbed portion 92 having a second plurality of barbs 922 formed thereon. The first plurality of barbs 911 and the second plurality of barbs 922 are inclined towards a central portion 98 of the length of the suture 90 that is free of barbs, and are preferably provided on the first and second barbed portions 91 , 92 in a staggered and opposite-sided distribution, as depicted.

The suture may be 345mm long. Alternatively multiple lengths may be provided for different zones of the face, or different sized faces for example 375mm long. The suture may be 0.3mm thick. Alternatively multiple thicknesses may be provided for obtaining different tensile strengths. The suture 90 may be extruded from Polypropylene, Polycaprolactone, Poliactic Acid or Polydioxanone. Some of these materials, such as Polydioxanone are biocompatible and biodegradable. As such, the face lift effect is temporary and the suture assembly 100 does not stay implanted permanently. This also reduces risk of complications.

In the first embodiment, at the time of assembly with the anchor 80, the suture 90 is manipulated to result in both the first barbed portion 91 and the second barbed portion 92 being generally alongside each other on a same side of the knot 99. This allows both the first barbed portion 91 and the second barbed portion 92 to be threaded together into a leading end 81 of the anchor 80, through the anchor 80, and out a trailing end 82 of the anchor, as shown in FIG. 3 (barbs not depicted), such that the knot 99 is opposite the two free ends 910, 920 of the suture 90.

After complete assembly of the suture 90 with the anchor 80 to form the first embodiment of the suture assembly 100, as shown in FIG. 4 (barbs not depicted), the first barbed portion 91 and the second barbed portion 92 extend from the trailing end 82 of the anchor 80 while the knot 99 is fully contained within the anchor 80. In this way, no part of the suture 90 projects beyond the leading end 81 of the anchor 80. During implantation of thee suture assembly 100 into the patient, the leading end 81 of the anchor first enters and leads the movement of the suture assembly 100 into the entry site 108 and along the canula. As can be seen in FIGS. 4 and 5, the first embodiment of the anchor 80 comprises a rigid portion 88 having the leading end 81 and the trailing end 82. The rigid portion 88 preferably comprises a generally cylindrical tube as shown, although any other suitable shapes may also be used, so long as the rigid portion 88 has a longitudinal through hole. The anchor 80 comprises a suture engager 89 in the form of a narrowed neck 89 provided within the central longitudinal through hole of the rigid portion 88, at a distance from the leading end 81. The narrowed neck 89 is configured to engage the knot 99 of the suture 90 so that the knot 99 lies on one side of the narrowed neck 89 in the longitudinal through hole of the rigid portion 88 while allowing the first barbed portion 91 and second barbed portion 92 of the suture 90 to extend out of the rigid portion 88 on the other side of the narrowed neck 89. The narrowed neck 89 and the leading end 81 thus define a space 83 within the rigid portion 88 for fully containing the knot 99 within the rigid portion 88 of the anchor 80, or at least to contain a majority of volume of the knot.

The narrowed neck 89 thus comprises an opening 87 configured to allow passage of the first and second barbed portions 91 , 92 of the suture 90 therethrough, and to prevent passage of the knot 99 therethrough. In one embodiment of the anchor 80, the opening 87 is elongate in a plane perpendicular to a central longitudinal axis L of the anchor 80, in order to have a minimally sized opening that allows both the first barbed portion 91 and the second barbed portion 92 to be simultaneously passed through the narrowed neck 89.

By configuring the anchor 80 to allow the knot 99 of the suture 90 to be contained within the rigid portion 88 of the anchor 80, and by providing the knot 99 at the central portion 98 of the suture 90 rather than at the ends 910, 920 of the suture 90, no part of the suture 90 projects beyond the leading end 81 of the anchor 80. Furthermore, as the overhand knot 99 is significantly smaller than other knots that are required to securely tie two free ends of a suture together, the overhand knot 99 can be fully accommodated within the rigid portion 88 without requiring the rigid portion 88 to be enlarged. Enlargement of the rigid portion 88 is not desirable as this would require a larger cannula and entry site for implantation.

In a variation of the first embodiment of the suture assembly 100, instead of the knot 99 provided at the central portion 98 of the suture 90, a bead (not shown) of diameter greater than the diameter than the suture 90 may be provided at the central portion 98 of the suture 90. The centrally provided bead on the suture 90 should be small enough to be contained within the rigid portion 88 of the anchor 80 while also being large enough not to pass through the narrowed neck 89 of the rigid portion 88. The bead thus functions in the same way as the knot 99, and and may be secured to the suture 90 by any appropriate means, such as soldering or glueing. From the above description of the first embodiment, it may be said that the anchor 80 has a narrowed neck 89 configured to engage an enlarged portion 99 of the central portion 98 of the suture 90 at a distance from the leading end 81 of the anchor 80, the enlarged portion 99 being a knot 99 or a bead (not shown).

In a second embodiment of the suture assembly 100, as shown in FIGS. 6 and 7 (barbs not depicted), the anchor 80 comprises a rigid portion 88 having the leading end 81 and the trailing end 82. The rigid portion 88 preferably comprises a generally cylindrical block as shown, although any other suitable shapes may also be used. The anchor 80 comprises a suture engager 89 in the form of a channel 89 provided in the rigid portion 88 from the leading end 81. The channel 89 extends across the leading end 81 into the rigid portion 88 so as to separate the leading end 81 of the anchor 80 into two parts 81-1 , 81-2. The channel 89 is configured to engage the central portion 98 of the second embodiment of the suture 90 at a distance from the leading end 81 , as shown in FIG. 2B, via a press fit or friction fit. In this way, the central portion 98 of the suture 90 is held within the rigid portion 88 and no part of the of the suture 90 projects beyond the leading end 81 of the anchor 80. In a preferred configuration of the second embodiment, a groove 87 may extend from the channel 89 longitudinally down each side of the rigid portion 88, such that each groove 87 is contiguous with the channel 89 to at least partially accommodate part of the suture 90 that is on each side of the central portion 98 in the channel 89. In this way, overall width of the suture assembly 100 at the anchor may be minimized.

In the second embodiment, during assembly of the suture 90 with the anchor 80, unlike the first embodiment, no knot needs to be made at the central portion 98 of the suture 90, and the suture 90 does not need to be passed through any narrowed neck. In the second embodiment, manipulating and handling of the suture 90 is therefore minimized to avoid potential damage to the barbs.

For all embodiments, it will be noted that the suture engager 89 of the anchor 80 is configured to engage a central portion 98 of the suture 90 (with or without a knot or a bead) within the rigid portion 88 such that no part of the of the suture 90 projects beyond the leading end 81 of the anchor 80. In this way, the practitioner can achieve better precision in the implantation of all embodiments of the suture assembly 100 of the present invention as no spatial allowance needs to be estimated by the practitioner for provision to accommodate extraneous suture that, in prior art systems, project beyond the leading end 81 of the anchor 80.

Besides the rigid portion 88, for all embodiments, the anchor 80 also comprises at least two resilient portions 84 projecting laterally from the rigid portion 88. The two resilient portions 84 are configured to allow alteration of a greatest lateral diameter or width of the anchor 80 (as defined by including the at least two resilient portions 84), depending on whether the anchor 80 is in a free state or in a compressed state. In the free state, the greatest lateral diameter or width of the anchor 80 is larger than a diameter of the entry site of the suture assembly 100.

The at least two resilient portions 84 are configured to be displaceable towards the central longitudinal axis L of the anchor 80 to result in the anchor 80 being in the compressed state. In the compressed state, the greatest lateral diameter or width of the anchor 80 is within the diameter of the entry site of the suture assembly 100, so that the compressed state allows passage of the anchor 80 through a cannula (not shown) that provides the entry site during implantation of the anchor 80 in the patient. During implantation, upon the anchor 80 exiting the cannula, the at least two resilient portions 84 spring back to their undisplaced positions so that the anchor 80 is again in the free state. In the free state, the at least two resilient portions 84 are configured to engage facial tissue of a patient to inhibit downward movement of the anchor 80 when the anchor 80 is implanted in the final implantation position in the patient.

In one embodiment, the at least two resilient portions 84 are symmetrically provided about the central longitudinal axis L of the anchor 80. Preferably, the at least two resilient portions are provided at the trailing end 82 of the rigid portion 88. In other embodiments, the at least two resilient portions may alternatively be provided at the leading end 81 of the rigid portion 88.

For all embodiments, the anchor 80 may be moulded from a biodegradable material. This will degrade so that the anchor 80 does not stay implanted permanently. This also reduces the risk of complications. In use, the anchor 80 will stay inside the tissue and dissolve at an equal or lower rate than the suture 90, ensuring the reliability of the lift over the lifetime of the suture assembly 100.

Whilst there have been described in the foregoing description preferred embodiments of the present invention, it will be understood by those skilled in the technology concerned that many variations or modifications in details of design or construction may be made without departing from the present invention. For example, the narrowed neck may be provided at the trailing end instead of centrally within the rigid portion, as depicted in the figures.

Claims

1. An anchor for a suture assembly, the anchor comprising:

a rigid portion having a leading end;

a suture engager configured to engage a central portion of a length of suture at a distance from the leading end wherein no portion of the suture projects beyond the leading end; and

at least two resilient portions projecting laterally from the rigid portion, the at least two resilient portions configured to be displaceable towards a central longitudinal axis of the anchor to allow passage of the anchor through a cannula during implantation of the suture assembly in a patient, the at least two resilient portions further configured to return to their undisplaced positions once the anchor exits the cannula in order to engage facial tissue of the patient to resist movement of the anchor after the anchor is implanted in the patient.

2. The anchor of claim 1 , wherein the suture engager comprises a narrowed neck provided within the rigid portion at a distance from the leading end, the narrowed neck configured to engage an enlarged portion of the central portion of the length of suture, the narrowed neck and the leading end defining a space within the rigid portion for containing at least a majority of volume of the enlarged portion within the rigid portion.

3. The anchor of claim 2, wherein the narrowed neck comprises an opening configured to allow passage of two portions of suture therethrough and to prevent passage of the enlarged portion therethrough.

4. The anchor of claim 3, wherein the opening is elongate in a plane perpendicular to the central longitudinal axis of the anchor.

5. The anchor of any preceding claim, wherein the space is configured to fully contain the volume of the enlarged portion therein.

6. The anchor of any one of claims 2 to 5, wherein the enlarged portion comprises one of: a knot of the suture and a bead secured to the suture.

7. The anchor of claim 1 , wherein the suture engager comprises a channel extending across the leading end into the rigid portion.

8. The anchor of claim 7, wherein the channel is configured to engage the central portion of the length of suture via a press fit.

9. The anchor of claim 7 or claim 8, wherein the rigid portion comprises a groove on each side of the rigid portion, each groove extending longitudinally down each side of the rigid portion

10. A suture for a suture assembly, the suture comprising:

a single length of suture;

a first barbed portion having a first plurality of barbs formed thereon; and a second barbed portion having a second plurality of barbs formed thereon, wherein the first plurality of barbs and the second plurality of barbs are inclined towards a central portion of the length of suture.

11. The suture of claim 10, having a knot tied at the central portion of the length of suture.

12. The suture of claim 11 , wherein the knot comprises an overhand knot.

13. The suture of claim 11 or 12, wherein prior to assembly of the suture with an anchor of the suture assembly, the first barbed portion is on a first side of the knot and the second barbed portion is on a second side of the knot, and wherein at the time of assembly of the suture with the anchor, the first barbed portion and the second barbed portion are generally alongside each other on a same side of the knot.

14. A suture assembly comprising the anchor of any one of claims 1 to 6 and the suture of any one of claims 10 to 13.

15. A suture assembly comprising the anchor of any one of claims 1 and claims 7 to 9 and the suture of claim 10.