BRPI0720186B1 - threading device for suturing - Google Patents

Description

(54) Title: THREADING DEVICE FOR SUTURING (73) Holder: IMPLICITCARE, LLC., North American Society. Address: 436 North Bedford Drive, Suite 103 Beverly Hills CA 90210, UNITED STATES OF AMERICA (US) (72) Inventor: GREGORY PAUL MUELLER; CORBETT STONE.

Validity Period: 10 (ten) years from 11/06/2018, subject to legal conditions

Issued on: 11/06/2018

Digitally signed by:

Liane Elizabeth Caldeira Lage

Director of Patents, Computer Programs and Topographies of Integrated Circuits

1/52

THREADING DEVICE FOR SUTURING

Field of the invention [001] The present invention generally relates to methods and devices for plastic surgery and, more particularly, to a neck lifting procedure that is minimally invasive and to the instruments for carrying out the procedure.

Background to the invention [002] Conventional neck rejuvenation surgeons advocate procedures that alter the anatomy of the neck to restore a younger neck contour. These involve manipulating the platysma such as advancing and / or dividing the muscle, and often the excision of fat from below the platysma. Partial resection of the submandibular glandular tissue can also be performed. These techniques vary in complexity and can result in significant complications, including postoperative bleeding, nerve damage, permanently visible skin deformities caused by the muscle divista, or exaggerated fat resection.

[003] Plastic and reconstructive surgeons have long sought to develop methods and devices to help support physical structures that have lost their natural tensions and supports. The most frequently treated areas include the face, the thoracic region, the buttocks and other regions that lose tension and support. Current devices are not always suitable for providing a natural appearance of the structure to prevent such loss of tension in these structures.

[004] The aging process causes changes

Petition 870180057245, of 07/02/2018, p. 7/61

2/52 gradual and predictable in the soft tissue layers of the lower face and neck, the anatomical basis of which has been well documented. Loss of elasticity and collagen fragmentation result in the formation of wrinkles (rhytid) and excess skin. Subcutaneous fat thickens and decays or is ptotic and becomes more visible. Stretching of the fascia and musculature results in a loss of the submental support bandage, often resulting in ptosis of the submandibular gland. The additional loss of tone and muscle atrophy result in the junction of the medial edges of the platysma, attenuation of the cervicomental angle and loss of the mandibular lateral definition.

[005] The failure of the classic neck lift to adequately treat the consequences of aging in the neck led to the development of a series of modifications and adjuvant procedures. These include skin excisions, various lipoplasty techniques, anterior or posterior transection based on platysma, resection or plication procedures, SMAS-platysma flaps, and suspension suture techniques. However, these modifications have their limitations.

[006] Problems with scar contractions and hypertrophic scarring resulted in almost abandonment of midline skin excision with subsequent Z, W or Tplasty. Liposuction or direct liposculpture plays an important role in the aging of the neck.

Summary of preferred embodiments [007] In accordance with a first aspect of the present invention, a method is provided for threading a suture on a patient's body. The method includes the steps of providing

Petition 870180057245, of 07/02/2018, p. 8/61

3/52 a suture, provide a threading device comprising an elongated stem that has a local tieoff (obstruct) suture and first and second ends, tying the suture to the local tie-off suture, introducing the first end of the elongated stem through a first opening in the patient's skin, passing the first end of the elongated nail subcutaneously to a second opening in the patient's skin, pulling the first end of the elongated nail and part of the suture through the second opening, without turning the elongated nail around , and passing the second end of the elongated nail subcutaneously to an opening in the patient's skin. At at least one point during the method, the first end of the elongated rod extends out of the first opening and the second end of the elongated rod extends through the second opening. In a preferred embodiment, the first and second ends of the threading device are each illuminated at predetermined points during the method.

[008] In accordance with another aspect of the present invention, a method of performing the surgery is provided. The method includes the steps of placing a tape template on a portion of a patient's skin, marking a plurality of access sites, making an opening to form a midline access site, performing liposuction, forming a plurality of openings in the skin at the access sites, providing a threading device that has a suture attached to it, and introducing the threading device and the suture through a plurality of access sites to form a suture matrix under the

Petition 870180057245, of 07/02/2018, p. 9/61

4/52 skin.

[009] In accordance with yet another aspect of the present invention, a surgical kit is provided which includes at least two of the following: at least one tape element, a lancet, a hand device, a cleaning device, a nozzle, a threading device, and a suture. In a preferred embodiment, the handheld device includes a tubular member having first and second opposites, an instrument coupling that extends from the first end of the tubular member which includes an opening for receiving a rod and a light source, where the light of the light source is directed out of the opening in the instrument coupling. The threading device preferably includes an elongated stem, which has a groove defined therein that extends at least substantially circumferential around the stem, and blunt ends. The threading device preferably also includes an elongated tube having first and second ends open and a local tie-off suture arranged approximately in the middle between the first and second ends, and a light guide passing through the elongated tube. The light guide has the first and second ends that are substantially flush with the first and second ends of the tube. The tape element preferably includes a first layer that has at least two perforations defined through it, and a second layer overlying the first layer that has at least two perforations defined through it. At least one of the perforations in the second layer at least partially overlaps at least one of the

Petition 870180057245, of 07/02/2018, p. 10/61

5/52 perforations of the first layer. The cleaning device preferably includes a neck and a cleaning portion that extends from the neck in a curved path that defines a plane that is approximately perpendicular to the longitudinal axis of the neck.

Brief description of the figures [010] The invention can be more easily understood by referring to accompanying drawings in which:

FIG. 1 is a perspective view of a tape mold according to a preferred embodiment of the present invention;

FIG. 2 is a view of the tape template of FIG. 1 being used to mark puncture sites on a patient's chin;

FIG. 3 is a top view of the front of a lancet according to a preferred embodiment of the present invention;

FIG. 4 is a perspective view of the lancet of FIG. 3;

FIG. 5 is a view of the lancet of FIG. 3 being used to make a puncture;

FIG. 6 is a top view of the side of a handheld device according to a preferred embodiment of the present invention;

FIG. 7 is a top sectional side view of the handheld of FIG. 5 showing the optical fiber core;

FIG. 8 is a cross-sectional view of the handheld device

FIG. 5 before coupling with a portion of the skin according to a preferred embodiment of the present invention;

Petition 870180057245, of 07/02/2018, p. 11/61 ¢ / 52

FIG. 9 is a cross-sectional view showing the port of the skin introduced into a patient's skin prior to deployment;

FIG. 10 is a sectional view showing the port of the skin introduced into a patient's skin after unfolding;

FIG. 11 is a perspective view of the skin port;

FIG. 12 is a cross-sectional view of another embodiment of a skin port;

FIG. 13 is a top view of the side of a threading device according to a preferred embodiment of the present invention;

FIG. 14 is a top sectional side view of the threading device of FIG. 13;

FIG. 15 is a view of the threading device of FIG. 13 being used on a patient;

FIG. 16 is another view of the threading device of FIG. 13 being used on a patient;

FIG. 17 illustrates the threading device of FIG. 13 passing through the subcutaneous facial ligaments and neurovascular structures;

FIG. 18 is a top side view of an instrument that positions the knot according to a preferred embodiment of the present invention;

FIG. 19 is a view of a patient with a threaded skin port placed at the mid-line submental access site and a suture node extending thereafter;

FIG. 20 is a cross-sectional view of the instrument that positions the node of FIG. 15 pushing the knot through the port

Petition 870180057245, of 07/02/2018, p. 12/61

7/52 of the threaded skin and under the skin of a patient;

FIG. 21 is a top side view of a threaded skin port according to a preferred embodiment of the present invention;

FIG. 22 is a top sectional side view of the threaded skin port of FIG. 21;

FIG. 23 is a perspective view of the threaded skin port of FIG. 21;

FIG. 24 is a top side view of a fiber optic suture according to a preferred embodiment of the present invention;

FIG. 25 is a view of a patient with the support matrix shown in hidden lines;

FIG. 26 is a fragmentary perspective view of a laminated tape mold according to a preferred embodiment of the present invention;

FIG. 27 is a view of the laminated tape template of FIG. 2 6 being used to mark the puncture sites on a patient's chin;

FIG. 28 is a perspective view of a handheld device according to a preferred embodiment of the present invention;

FIG. 29 is a fragmentary perspective view of the handheld of FIG. 28;

FIG. 30 is a detailed perspective view of the instrument coupling of the handheld device of FIG. 28;

THE FIG. 31 it's a sight the end of the device hand of FIG. 28; THE FIG. 32 it's a sight in detailed perspective of a

another preferred method of coupling the instrument

Petition 870180057245, of 07/02/2018, p. 13/61

8/52 handheld device of FIG. 28;

FIG. 33 is a perspective view of a cleaning device attached to the end of the handheld of FIG. 28;

FIG. 34 is a sectional view taken along line 34—34 of FIG. 33;

FIG. 35a is a perspective view of another cleaning device attached to the end of the hand device of FIG. 28;

FIG. 35b is a perspective view of another cleaning device attached to the end of the hand device of FIG. 28;

FIG. 36 is a perspective view of a threading device according to a preferred embodiment of the present invention;

FIG. 37 is a top detailed view of a portion of the threading device of FIG. 36 showing that it is tapered;

FIG. 38 is a fragmentary perspective view of the threading device of FIG. 36;

FIG. 39 is a top detailed view of a portion of a threading device that includes an orifice;

FIG. 40 is a partial sectional elevation of a threading device with an independent energy source and light source according to another preferred embodiment of the present invention;

FIG. 41 is a perspective view of a threading rod according to a preferred embodiment of the present invention;

FIG. 42 is a detailed perspective view of the

Petition 870180057245, of 07/02/2018, p. 14/61

9/52 threading rod of FIG. 41 showing the groove;

FIG. 43 is a sectional elevation of one end of the screw rod of FIG. 41 taken along lines 43-43 of FIG. 41;

FIG. 44 is a perspective view of the threading device of FIG. 36 inserted in a handheld device;

FIG. 45 is a sectional elevation taken along line 45 - -45 of FIG. 44;

FIG. 46 is a fragmentary perspective view of a handheld device and a cleaning device according to another preferred embodiment of the present invention;

FIG. 47 is a top cross-sectional view of a handheld device with a cleaning device assembly thereon according to another preferred embodiment of the present invention;

FIG. 48 is a top sectional view of a handheld device with a spout in it, according to another preferred embodiment of the present invention;

FIG. 49 is a perspective view of a threading rod according to another preferred embodiment of the present invention;

FIG. 50 is a top sectional view of a handheld device with the screw rod of FIG. 4 9 fixed on it;

FIG. 51 is a patient's view showing the use of a cleaning device to clean an access point;

FIG. 52 is a patient's view showing the insertion of the threading rod and the first suture in the

Petition 870180057245, of 07/02/2018, p. 15/61

10/52 access site 14a using the handheld device;

FIG. 53 is the view of a patient showing the insertion of the threading rod and the first suture at the access site 14b after turning the threading rod;

FIG. 54 is a view of a patient showing the insertion of the threading rod and the second suture at the access site 14a using the hand device after the first entire suture has been placed;

FIG. 55 is a view of a patient showing the insertion of the threading rod and the second suture at the access point 14g after turning the threading rod;

FIG. 56 is a view of a patient showing the final placement of the support matrix with two sutures before the nodes are pushed through the access points;

FIG. 57 is a top side view of a threading device according to another preferred embodiment of the present invention; and

FIG. 58 is a top side view of a threading device according to another preferred embodiment of the present invention.

[011] Similar numbers refer to similar parts from different views of the drawings.

Detailed description of preferred embodiments [012] Preferred embodiments of a technique for placing a suture on a person's body are described here. The technique is preferably used in the field of plastic surgery and involves several steps in which each requires specific instrumentation.

[013] For exemplary purposes only, preferred modalities are described below where the technique

Petition 870180057245, of 07/02/2018, p. 16/61

11/52 and the instruments of the present invention are used to perform a NECK LIFTING, referred to here as percutaneous trampoline platysmaplasty. However, it will be understood that this is not a limitation on the present invention and that the technique and instruments can be used as desired by one of ordinary skill in the art.

[014] The liposuction part of the procedure is performed without a large incision under the chin. The suture support matrix is placed through several small access points in the neck area under the mandible. The advantage is that the entire support system can be placed without the large typical incision under the chin that is necessary for the surgeon to see the operative field. In addition, surgery is less invasive and does not require extensive skin dissection in the area under the chin.

[015] The exact placement of the support suture (s) (also referred to here as the support structure or support matrix 200, and shown in FIGS. 25 and 56) will be described here along with the description of each instruments or individual devices that can be used in connection with such a procedure.

[016] As described above, the inventive aspects of the present invention involve the placement of the support matrix 200 and not the actual liposuction technique. Consequently, it will be understood that any references to liposuction techniques here, are exemplary only.

[017] It will be appreciated that terms such as front, back, top, bottom, side, right, left, up and down used here are

Petition 870180057245, of 07/02/2018, p. 17/61

12/52 only for easy description and refer to the orientation of the components as shown in the figures. It should be understood that any orientation of the instruments and articles and their components described herein are within the scope of the present invention.

[018] Referring to FIGS. 1-2, the template ribbon (or ribbon elements) 10 will be described. In a preferred embodiment, tape 10 is a piece of clear tape with perforations 12 therethrough which are spaced apart at predetermined positions. The tape 10 includes the adhesive thereon so that it can be attached to the patient's skin. In an exemplary embodiment, tape 10 is a clear one inch wide tape with circular perforations 12 of approximately 2 millimeters defined through it, which are spaced every 5 millimeters along the center of the tape. The perforations 12 are preferably positioned along the longitudinal center of the tape 10, however this is not a limitation in the present invention. In another embodiment, tape 10 is not clear. In a preferred embodiment, tape 10 is supplied in a roll form. However, this is not a limitation on the present invention.

[019] Tape 10 is used in immediate preoperative planning to determine the placement of access sites 14, which will determine the placement of support matrix 200. Tape 10 is used as a guide to help provide good placement for each suture and its corresponding pivot point (as described below). Perforations 12 are used to mark access points 14 for surgery.

[020] In a preferred mode, the first and the

Petition 870180057245, of 07/02/2018, p. 18/61

13/52 according to elements of the tape 10 are placed on each side of the skin overlying the lower surface of the jaw, as shown in FIG. 2. Preferably, tape 10 is used with the patient sitting upright, which allows the natural contours of the neck to be visible. This is not a limitation on the present invention, however. The surgeon uses tape 10 and a plurality of perforations 12 to develop a surgical approach that is individually adapted for each patient, depending on the desired correction. As those skilled in the art will appreciate, the placement of the support matrix 200 will be different for different patients depending on the patient's anatomy.

[021] The example of a distance of 5 mm between perforations 12 allows the placement of pivot points in close proximity. This results in a dense support matrix allowing the elevation of muscle and glandular tissue. For example, pivot points can be placed 1-2 cm apart if minimal support is required. Those skilled in the art will be able to make determinations as to where access points 14 should be located, based on the needs of the patient. For example, as shown in FIG. 2, the surgeon chose only four access sites 14 on each side.

[022] As shown in FIG. 2, after the tape 10 has been placed and the surgeon has determined the structure of the support matrix 200, the surgeon marks the exposed skin through the desired perforations 12 with a surgical marking pen or the like. These markings 14 indicate the areas that require the placement of the suture to elevate the tissue

Petition 870180057245, of 07/02/2018, p. 19/61

14/52 mole of the neck. In a preferred embodiment, as shown in FIGS. 2 and 5, the markings 14 made using the first element of the tape 10 are symmetrical to the markings 14 made using the second element of the tape 10.

[023] As will be described below, each of the markings 14 defines an access position or location that will be punctured to allow subcutaneous access at that location. For simplicity, as each access point is marked and then punctured, the access points, markings and punches will all be marked here 14.

[024] As will be appreciated by those skilled in the art, in areas where significant platysma junction or glandular ptosis is evident, significant support will be required. To achieve this goal, several strands of suture will be required. While each area to be elevated is recognized, a corresponding perforation 12 of the tape is marked 14 to insure that the placement of the suture is accurate.

[025] As shown in FIGS. 26-27, in another preferred embodiment, tape 310 can be laminated. The ribbon

310 laminate preferably includes two layers 311 and 313. As shown in FIG. 26, the upper layer 313 has a set of holes or perforations 313a and the lower layer

311 has two sets of perforations 311a and 311b. The perforations 311a and 313a in the different layers 311 and 313 are preferably concentric. However, any amount of overlap between perforations 311a and 313a is within the scope of the present invention. This arrangement of perforations helps the surgeon to mark the patient.

[026] As described below, support matrix 200 is formed similar to the way a shoelace is passed

Petition 870180057245, of 07/02/2018, p. 20/61

15/52 through a shoe. Consequently, when marking the skin for access points 14, it may be useful to mark the skin with two markers of different colors, for example, red and blue (shown as continuous and dotted in the figures). Then, when the matrix 200 is created or the shoe is tied, the surgeon goes from the blue marking to the blue marking and from the red marking to the red marking (that each one has an access point 14 there formed, as described below).

[027] In use, the surgeon positions the laminated tape 310 as desired and marks the perforations (perforations 311a and 313a concentric or double) with the first color. Then, the surgeon peels the first or top layer 313 off, thereby exposing the second set of perforations 311b. The surgeon then marks the second set of perforations 311b with a different colored marker. Ribbon 310 can also be configured as a roll. In another preferred embodiment, a single piece of tape 310 can be used that extends around the entire jaw line or another position on the body. This helps to align the markings on each side.

[028] It will be understood that tape 10 or 310 is preferably used before performing liposuction or any other desired procedure. However, this is not a limitation on the present invention. In another mode, the tape can be used after liposuction is performed. In another embodiment, the tape can be omitted and the surgeon can mark or puncture the skin as desired.

[029] It will be appreciated by those skilled in the art that tape 10 or 310 can be used on areas of the body that

Petition 870180057245, of 07/02/2018, p. 21/61

16/52 don't be the chin. For example, the tape (and the rest of the procedure described below) can be used for a face lift or MACS-lift or when placing a definition suture on the neck (both described below).

[030] After the desired markings 14 have been made, the patient is ready for liposuction. It will be understood that when the surgical procedure does not include liposuction, the appointments are made before any procedure is performed. The patient's head and neck are prepared and covered in a sterile form and a local anesthetic is injected into the area under the chin. A small opening (referred to here as the mid-line submental access point) is made in this area. Tumescent fluid is injected into the entire area under the chin, including the neck area. Liposuction is performed throughout the region. Upon completion, the area is once again infiltrated with the tumescent fluid. This subcutaneous infusion results in the elevation of the platysma muscle skin.

[031] With reference to FIGS. 3-5, after the completion of liposuction, the patient is ready to place support matrix 200. A lancet 40 is used to create access points 14 by puncturing the dermis at the points marked using tape 10 or 310.

[032] As shown in FIG. 3, the lancet 40 includes a blade 42 that has two sharp edges 43 that end at a point 44 with two blind edges 46 below. In a preferred embodiment, blade 42 is approximately 8 millimeters in length. The blunt edges 46 of the blade 42 extend from a protruding edge or a stop element 48 that prevents the blade 42 from going deeper into the skin than desired.

Petition 870180057245, of 07/02/2018, p. 22/61

17/52

The protruding edge 48 ensures consistent depth of blade penetration. Also, blade 42 is tailored to allow placement of skin ports 80 as described below.

[033] The stop element 48 has an upper surface 48a and a lower surface 48b. The blade 42 extends above the upper surface 48a of the stop member 48. As shown in FIG. 3, the two sharp edges 43 each have first and second ends 43a and 43b, respectively, and the two blind edges 46 each have first and second ends 46a and 46b, respectively.

[034] In a preferred embodiment, the first ends 43a of the sharp edges 43 are at point 44 and extend below point 44 at an angle of 90 ° or less. The first ends 46a of the two blind edges 46 extend downwardly from the second ends 43b of the two sharp edges 43. The sharp edges 43 and the blind edges 46 are at an obtuse angle. The second ends 46b of the two blind edges 46 are connected to the stop member 48, which, in a preferred embodiment, is disk-shaped. However, this is not a limitation on the present invention. In an alternative embodiment, the blade 42 may extend from the stop member 48 at a non-right angle (for example, an acute angle).

[035] In a preferred embodiment, the lancet 40 includes an accessory element 50 that extends below the bottom surface 48b of the stop element 48 and allows the lancet 40 to be attached to a standard scalpel handle

Petition 870180057245, of 07/02/2018, p. 23/61

18/52

52. In another embodiment, lancet 40 can be supplied with a single cable.

[036] The subcutaneous infusion described above results in the elevation of the skin of the platysma muscle. Once infiltrated, access sites 14 are developed by puncture the skin with the percutaneous lancet 40 at the markings developed using tape 10, as shown in FIG. 5. The lancet 40 allows the skin to be punctured in order to gain access to the neck region and preferably ensures that each access point is as small as possible, allowing the placement of the support system 200.

[037] It will be understood that in a preferred mode, lancet 40 creates punctures instead of incisions, which minimizes trauma and the risk of scarring. However, the incisions can be used in another modality.

[038] Referring to FIGS. 6-7, the next instrument used in the procedure is a handheld device or a cable 60. The handheld device 60 is incorporated into a reusable insertion device with a 64 coupling of the instrument at one end of it. In a preferred embodiment, handheld device 60 also includes a fiber optic light port 62. In a preferred embodiment, the handheld device is ergonomically designed to fit the surgeon's hand when held. However, this is not a limitation on the present invention. Preferably, the handheld device 60 is made of a metal, such as stainless steel or titanium. However, it can be made of other materials, such as plastic or the like.

As described below, port 64 of the instrument is compatible with a number of instruments that are used

Petition 870180057245, of 07/02/2018, p. 24/61

19/52 in the surgical procedure of the invention. The design of the structure and the shape allow the ability to switch from the right hand to the left with ease and precision.

[039] In a preferred embodiment, the coupling 64 of the instrument includes a threaded inner surface or a threaded female connector 66 and a larger male connector 68 that mesh with the skin ports 80 (described below) allowing for distribution and lighting. The coupling 64 of the instrument is adapted to mate with certain instruments, as will be described more fully below. Handheld device 60 will be described more fully below in conjunction with the instruments with which it is intended to be used.

[040] Fiber optic light port 62 allows coupling to a fiber optic light cable (not shown). The transmission of fiber optic light through the handheld device 60 illuminates each device when it is attached to the working end of the instrument coupling 64.

[041] In a preferred embodiment, the handheld device 60 includes an optical fiber core 70, which is composed of at least one, and preferably a plurality, of optical fiber wires. When a fiber optic light cable is connected to light port 62, light is transmitted through the fibers and out through an opening 72 which is coaxial with the female connector 66.

[042] In another mode, other types of lighting can be used. For example, LED, incandescent, fluorescent and other light sources can be used. However, it will be understood that light transmission is not a limitation on the invention. The device

Petition 870180057245, of 07/02/2018, p. 25/61

20/52 hand 60 (and associated instruments) can be supplied without a fiber optic core.

[043] Referring to FIGS. 28-34, another embodiment of a handheld device or lighting device 360 is shown. In a preferred embodiment, the handheld device 360 is battery operated and disposable.

[044] As shown in FIG. 29, the handheld device includes a portion 359 of the main body, socket 361, power source (s) 363, light source 365, instrument coupling 364 and a shutter or cleaning device 321 (described more fully below). Preferably light source 365 is an LED light source 365a and power source 363 includes a plurality of batteries 363 arranged in series in socket 361. The circuit for supplying power to the light source is well known in the art and therefore a description will be omitted. In a preferred embodiment, the handheld device (in particular, the socket 361) is generally tubular. That is, it does not have to have a circular cross section; it can be square, oval or otherwise.

[045] In a preferred embodiment, the 360 handheld is provided with batteries 363 in it. In this mode, something is used to break the circuit so that the batteries are not drained before use. For example, a thin piece of paper or the like (referred to here as a break cord or circuit breaker 369) can be inserted between two batteries 363 to keep the circuit open and is then removed for an appropriate time to allow electrical communication between the batteries, thereby closing the circuit and turning on the light source 365. As

Petition 870180057245, of 07/02/2018, p. 26/61

21/52 shown in FIG. 29, the socket preferably has a groove 371 defined therein through which the breaking cord 369 extends.

[046] In use, when the surgeon is ready to use the 360 handheld device, he / she pulls the rupture cord to energize LED 365a and it will then function for a predetermined period of time (for example, until the batteries run out). It will be understood that the handheld device 360 can also be constructed so that it is reusable. For example, those skilled in the art will understand that it can be designed to be plugged into a regular wall outlet and operate on AC power.

[047] In a preferred embodiment, the energy source and the light source are sealed on the outside of the 360 handheld device. This helps with sterilization and prevents contamination of the work area.

[048] In another preferred embodiment, instead of using a rupture cord, a locking switch mechanism can be used to activate the batteries or turn on the light source. Any method for attaching the lock switch mechanism is within the scope of the present invention. For example, as shown in FIGS. 46 and 47, the handheld device 360 may include a tail cone or button 337 which can be twisted or pressed to attach the device. Or, a switch can be located inside the female receiver 366. In this embodiment, when the cleaning device 321, the cleaning device assembly 341 or the threading rod 300 (described below) are inserted into the receiver 366, the switch is turned on. and the batteries and the LED are activated. For example, the

Petition 870180057245, of 07/02/2018, p. 27/61

22/52 ring located next to o-ring 335 in FIG. 4 6 could be coupled to a magnetically activated switch.

[049] The coupling of the instrument 364 and the cleaning device 321 are described more fully below.

[050] FIGS. 8-11 show a skin port 80. In a typical procedure, a plurality of skin port 80 is used. In a preferred embodiment, the skin ports 80 are disposable clear plastic gloves that are each inserted into one of the access points 14 created by the lancet 40.

[051] Generally, the port of the skin 80 includes a protruding edge or a cuff 82 that has a tube 84 that extends from it. One end of the tube or sleeve 84 is inserted into the punch 14 in the skin until the protruding edge 82 rests against the outer skin surface. The protruding edge 82 and the tube 84 cooperate to define a tunnel 86 that will give access to the area under the skin. Preferably, port 80 is comprised of clear colored plastic. However, port 80 can also be made of other materials, it doesn't have to be clear and it doesn't have to be colored.

[052] In a preferred embodiment, handheld device 60 or 360 is used to implement each port 80 through the individual access locations 14.

Preferably, the skin ports 80 come in a kit, however this is not a limitation in the present invention. The design of the handheld device 60 allows quick interlacing with the skin port 80 to remove it from the kit. It will be understood that any design that allows the handheld device 60 to interlock with or attach to the skin port 80 of

Petition 870180057245, of 07/02/2018, p. 28/61

23/52 so that it can be implanted at the access site 14 is within the scope of the present invention.

[053] In a preferred embodiment, port 80 is fitted to the male connector 68. For example, as shown in FIG. 8, the male connector 68 can include a ridge 68a that extends circumferentially around it that cooperates with a toothed ring 82a on the projecting edge 82. The ridge 68a and toothed ring 82a provide a suitable fit so that port 80 is coupled with the male connector 68 of the handheld device 60. Other suitable fitting arrangements are contemplated.

[054] Tube 84 is then introduced through access point 14. As shown in FIGS. 8-11, in a preferred embodiment, the skin port 80 includes an anchor system comprising a threading 88 on the outer surface of the tube 84 and a flexible mechanism 90. The flexible mechanism 90 preferably includes a pair of flexible members 90a which are connected to an internally threaded ring 90b that moves tube 84 up and down in threadings 88.

[055] As shown in FIG. 8, the male connector 68 includes a plurality of teeth 68b at one end of which are adapted to engage with teeth 82b in port 80. When port 80 is coupled as coupling 64 of the instrument, teeth 68b engage or engage with the teeth 82b. After tube 84 has been introduced through access site 14, to implement flexible mechanism 90, handheld device 60 is rotated clockwise (port 80 can be designed to rotate counterclockwise, too). As teeth 68b and 82b are coupled, the

Petition 870180057245, of 07/02/2018, p. 29/61

24/52 tube 84 rotates with the handpiece 60 and within the projecting edge 82, causing the internally threaded ring 90b to move upward along the threads 88. As can be seen in FIG. 11, the flexible members 90a include a flexible fold 90c. As the threaded ring 90b moves upward, the flexible elements 90a bend, as shown in FIG. 10, that way. providing an anchor and preventing port 80 from being pulled out of the access location 14. The flexible elements 90a can be arranged in an unfolded position (FIG. 9) and in a folded position (Fig. 10).

[056] In a preferred embodiment, the protruding edge 82 includes a plurality of tips 94 extending to

down from there, that burrow on the skin and help The anchor port 80 in the place. [057] During the placement of port 80, as O handheld device 60 includes the core 70 fiber optics and the port of the skin 80 of course, in above the insert, The

Transcutaneous visualization of the tip of the illuminated probe will allow the safe distribution of the skin port 80. Because of the anchoring system, as the hand device is removed, the ridge 68a moves away from the toothed ring 82a and the skin port 80 is fixed in place. In another embodiment, the surgeon can use his thumb to help separate port 80 from dock 64 of the instrument.

[058] Preferably, ports 80 are disposable and are used only for a single surgery. It will be understood that ports are used only to gain access to the surgical field. Consequently, the type of port used is not a limitation on the present invention.

Petition 870180057245, of 07/02/2018, p. 30/61

25/52

Any type of port that provides access through the skin is within the scope of the present invention. The transillumination of the light gives the surgeon a three-dimensional response.

[059] As shown in FIG. 12, in an alternative embodiment, port 96 can have a tube 84 that is oriented at a non-right angle with respect to the projecting edge 82. For example, tube 84 can be oriented at a 45 degree angle with respect to respect to the protruding edge.

[060] FIGS. 13-17 show a preferred embodiment of a threading device 100. In a preferred embodiment, the threading device 100 is a flexible stainless steel rod or tube that includes a hole 102 defined in it and rounded, blunt end 104. Preferably, the threading device 100 also includes a light guide 106 (which can be a fiber optic core) allowing the illumination of the tip 104. In this embodiment, the tip 104 is preferably made of a transparent material, such as a plastic that is attached to the main body of the threading device 100. The threading device 100 includes an end 108 which is designed to mate with a 64 coupling of the instrument or 364 of the handheld device 60 or 360. In a preferred embodiment, the end 108 is threaded for coupling with the female connector 66, however , it will be appreciated that end 108 can couple with coupling 64 of the instrument in different ways. For example, the coupling 64 of the instrument may include a screw assembly that holds the threading device 100 in place or some kind of adjustment of

Petition 870180057245, of 07/02/2018, p. 31/61

26/52 fitting or pressure can be provided. In another embodiment, a clamp or chuck, similar to that in a drill, can be used. Also, end 108 can be internally threaded and can engage with an externally threaded instrument coupling. The coupling 64 of the instrument allows quick connection and disconnection with the threading device 100.

[061] In a mode where the handheld device 60 includes a fiber optic light port 62, the coupling of the end 108 (which includes an opening 108a in it) with the coupling 64 of the instrument allows the transmission of light to the tip 104 threading device 100. In another embodiment, other types of lighting can be used. For example, LED, incandescent, fluorescent and other light sources can be used.

[062] It will be understood that hole 102 is used to secure suture 150. Hole 102 can be located anywhere along the threading device

100.

[063] In use, threading device 100 (and suture 150) is introduced through the various ports of the skin 80 and the support matrix 200 is woven and created.

[064] FIGS. 36-45 show another embodiment of a threading device or stem 300 that includes orifice 302 or groove 303 (referred to herein as a local tie-off suture) at a point that is approximately intermediate between the ends thereof. As shown in FIG. 52, in a preferred embodiment, suture 150 is tied around threading device 300 and received in groove 303. Groove 303 is defined

Petition 870180057245, of 07/02/2018, p. 32/61

27/52 preferably circumferentially around the outside of the device 300. However, in another embodiment, the groove extends only partially around the device 300. The device 300 can also have a setback 305 defined therein, in which the knot 150c is received. This reduces the contour of the knot 150c and helps to prevent the knot 150c from grabbing anything (ligaments, skin, suture, etc.) when the threading device 300 is used.

[065] As shown in FIG. 38, in a preferred embodiment, threading device 300 includes opposite ends or tips 304, tube 307, caps 304a and light guide 306. In another embodiment, threading device 300 is solid. In yet another modality, the tips and the light guide can be integral or the tips can be omitted. The threading device 300 can be solid metal with no lighting capability or it can be formed entirely of a solid (or plurality of components) made of a translucent conductor or a light conductor or a transmissive material (such as plastic) of so that the entire device lights up and / or so that the device is more flexible and easier and cheaper to manufacture. It will be understood that in a preferred embodiment, the ends or tips of the threading rod 300 are blind. As used here, blind means that the extremities do not puncture the skin or any other part of the patient's anatomy without sufficient strength (a force above that normally used in the procedure described below). As those skilled in the art will understand, a typical suture needle punctures the skin with very little pressure or force applied to it. At

Petition 870180057245, of 07/02/2018, p. 33/61

28/52 blunt ends of this threading device

300 (if flat or convex) do not puncture the skin when used as described below. However, in another mode, the ends can be sharp.

[066] In the eyelet mode, eyelet 302 can be formed so that when knot 150c is tied through it, it is received in a portion of the recess (now shown, but similar to recess 305).

[067] In yet another embodiment, a suture 150 and the threading device 300 can be formed as a unit. That is, the suture 150 is permanently attached to the threading device 300 and the two can be supplied to a surgeon as a unit.

[068] Preferably, the threading device 300 is malleable. For example, tube 307 can be made of stainless steel, titanium or another metal, and light guide 306 can be made of plastic (for example, acrylic, styrene, polycarbonate or the like) or glass.

[069] In another preferred embodiment, to make threading device 300 even more malleable (and easier to insert into access points 14), tube 307 can be tapered (or the entire threading device 300 can be tapered, at the case of a solid nail) from the ends to the groove 303, hole 302 or local tie-off suture (as shown in FIGS. 37 and 39). In another embodiment, as shown in FIGS. 41 and 49, the stem tapers from a first position 333a to the left of groove 303, to the first end, and the stem tapers from a second position 333b to the right of groove 303, to the second end. Consequently, the stem has a

Petition 870180057245, of 07/02/2018, p. 34/61

29/52 smaller diameter at the first and second ends than at the first and second positions. As shown in FIGS. 4142, excluding groove 303, the area between the first and second positions 333a and 333b has a constant diameter. This prevents the concentration of stress in the center of the stem 300 and helps prevent stem failure during use. It will be understood that the first and second positions 333a and 333b can be located anywhere along the length of the stem 300.

[070] As shown in FIG. 36, in a preferred embodiment, the threading device 300 is not rounded. For example, it can be hexagonal. In this embodiment, a female receiver 366 of the instrument coupling 364 of the handheld device 360 or 60 has a corresponding shape. This prevents the threading 300 from rotating when coupled,

In another embodiment, only the ends of the threading device 300 are polygonal. It will be understood that any way to close the threading rod and prevent it from turning is within the scope of the present invention. Also to help prevent the threading device 300 from being removed from the female receiver 366, the instrument coupling may have an elastomeric o-ring 335 in it that provides a friction fit with anything inserted into it.

[071] As shown in FIG. 38, tube 307 is hollow and light guide 306 passes through it. In a preferred embodiment, the ends 304 of the tube 307 are preferably capped by the end caps 304a. The end caps 304a are preferably hollow,

Petition 870180057245, of 07/02/2018, p. 35/61

30/52 made of a transparent plastic and preferably include a projecting edge 304b which is received in tube 307 in a pressure adjustment arrangement. Lids 304a can also be threaded or glued to the ends of tube 307. In a preferred embodiment, end caps 304a are projectile-shaped and provide total internal reflection.

[072] As shown in FIGS. 41-43, in another preferred embodiment, tube 307 is round, and light guide 306 is flush with the ends 304 of tube 307, and the recess described above is omitted. This modality also includes positions 333a and 333b described above. However, positions 333a and 333b can be omitted, consequently, by providing tube 307, excluding groove 303 with a constant diameter. In this embodiment, caps 304a are omitted. To fix the light guide 306 to the tube 307, the light guide 306 can be filled, which is an adhesive that fills the space between the light guide 306 and the inner diameter of the tube 307. It will be understood that the light guide 306 whole, or just the ends, can be filled. In this embodiment, the ends 304 of the stem 300 can be cut, polished and trimmed to promote light transmission and to make the ends of the tube 307 and the light guide 306 blush, as shown in FIG. 43. The ends 304 may be flat or convex.

[073] As will be appreciated by those skilled in the art, in a preferred mode, to promote total internal reflection in the 306 light guide, the 306 light guide can be coated. If a plastic light guide is used, the outside of the 306 light guide can be coated. If a guide

Petition 870180057245, of 07/02/2018, p. 36/61

31/52 of glass light is used, as is known in the art, the glass housing can be coated before the glass light guide is extracted. The use of the coating is not a limitation in the present invention, however, if not used, the bottled compound can decrease light transmission and make it less efficient.

[074] When the threading device 300 is coupled with the handheld device 360, light is transmitted through one end 304 of the stem 300, through the light guide 306, and out the other end 304. In a preferred embodiment , the bottom part of the female receiver 366 has a complementary shape to that of the ends 304, thereby providing efficient light transmission.

[075] In a preferred embodiment, a high-efficiency white LED is used. In this mode, the lighting device 360 can include a DC to DC converter to boost the voltage to the desired level for the high-efficiency white LED.

[076] It will be understood by those skilled in the art that it is desired that the light emitted by the LED be concentrated and emitted at a narrow angle of focus. In a preferred embodiment, the numerical opening of the light guide 306 is accompanied as closely as possible by the light emitted by the LED. This helps to maximize the efficiency of light transmission.

[077] Eat i shown at FIG. 40, in another modality, the device in threading 300 includes your source itself power 391 and source of light 393. In a

exemplary modality, the 391 energy source and the

Petition 870180057245, of 07/02/2018, p. 37/61

32/52 light 393 (eg LED) can be connected by wires

395. In this mode, the handheld device can be omitted. For example, threading device 300 may include an LED or the like at each end.

[078] In another embodiment, the handheld device can alternate the threading device to assist in passing the threading device through the subcutaneous route. The alternating action allows the threading device to easily pass through adipose tissue, thus creating less collateral damage to blood vessels, nerve structures and other subcutaneous ligaments. This embodiment is similar to the device for alternating a cannula, which is described in United States patent no. 6,139,518 to Mozsary, which is incorporated herein in its entirety by reference. In this embodiment, the handheld device is powered to switch the threading device back and forth during surgery. The threading device can be connected to the cable by a connector that is attached to, formed integrally with, or selectively connectable to an alternative element. In another embodiment, the handheld device can alternate or vibrate the threading device via ultrasound.

[079] FIGS. 33-35b show different modalities of the cleaning device 321, which is a blind instrument for probing the puncture or access site and cleaning ligaments and other obstructions. Generally, the cleaning device 321 includes a neck (also referred to as the coupling portion) 323 and a cleaning portion 325. The cleaning portion 323 is preferably about the same diameter as the threading rod 300, as such. way both

Petition 870180057245, of 07/02/2018, p. 38/61

33/52 fit into the access locations.

[080] As shown in FIGS. 33-34, in a preferred embodiment, the cleaning portion 325 is in the form of a spiral. This allows the surgeon to introduce the cleaning portion

325 at the access site 14 and sweep the area under the clean access site by rotating the device (see FIG. 51 for a figure describing the use of the cleaning device 321).

[081] In a preferred embodiment, the cleaning device 321 fits into the handheld device 360. To achieve this, the neck 323 and the coupling of the instrument 364 include the corresponding protrusions 327a and indentations 327b, as best shown in FIG. 34. The cleaning device 321 is preferably made of plastic, which allows flexibility for the fitting adjustment arrangement, and also allows the cleaning device 321 to be transilluminated. In use, light is emitted from the coupling of the instrument 364 and transilluminates the cleaning device 321. In another embodiment, only the tip of the cleaning device 321 is illuminated and the rest of the device is opaque. This helps to direct the light to the tip. In another embodiment, the cleaning device 321 may be made of metal.

[082] It will be understood that the cleaning device 321 may be attached to the handheld 360 in a removable manner in other ways. For example, an arrangement where a portion of the neck 323 is received in grooves in the handheld device 360 (or vice versa) and then the cleaning device is rotated and closed in the place that can be used. Also, as shown in FIG. 32, a 329 threaded arrangement is within the scope of this

Petition 870180057245, of 07/02/2018, p. 39/61

34/52 invention. The cleaning device 321 can also be designed to fit the handheld device 60.

[083] Referring to FIGS. 46-47, another embodiment of a cleaning device 321 is shown. In this embodiment, the cleaning device 321 can be a rod that engages the female receiver 366, as shown in FIG. 46. In this embodiment, the cleaning device 321 includes a neck (or coupling portion) 323 and a clarifying portion 323. Neck 323 can be closed (similar to the threading device, described below) to prevent rotation when introduced into the 366 female receiver.

[084] FIGS. 35a and 35b show other embodiments of a cleaning device with curved and straight 325b cleaning portions 325a. These cleaning portions can also be included in a cleaning device that is received at the female receiver 366 as well.

[085] Referring to FIGS. 46-49, another embodiment of a 360 handheld device is shown. The handheld device 360 is generally the same as described above. As shown in the figures, that of the instrument includes threading 329 and a circular female receiver 366. The handheld device 360 may also include a tail cone 337 as described above. The tail cone 337 can simply be to provide the surgeon with something to hold when turning the cleaning device, or it can be designed to trigger a locking switch to activate the light source, as described above.

[086] In this mode, the device also includes a

Petition 870180057245, of 07/02/2018, p. 40/61

35/52 nozzle 339 that can be threaded on the coupling 364 of the instrument. The nozzle 339 preferably includes the grip indentations 339a and has an axial opening 339c defined along which is axially aligned with the female receiver 366 when the nozzle 339 is threaded on the coupling 364 of the instrument. The nozzle 339 provides a handle for the surgeon when using the handheld 360. This allows the surgeon to hold the handheld similar to the way it would hold a pen.

[087] As shown in FIG. 46 (and as described above), the cleaning device 321 may have a neck 323 that engages the female receiver 366 and includes a cleaning portion 325 extending therefrom. As shown in FIG. 47, in another preferred embodiment, the nozzle and the cleaning device can be formed as a unit, thereby creating a set of cleaning device 341. In this embodiment, the neck 323 is inserted into the female receiver 366, while the nozzle 339 is threaded on the instrument coupling 364 simultaneously. The o-ring 335 helps to secure the neck 323 inside the female receiver 366. In this embodiment, the cleaning portion 325 extends in a curved path that defines a plane that is approximately perpendicular to the longitudinal axis of the neck.

[088] As shown in FIG. 47, the cleaning device assembly 341 may include a light guide 306 extending through it to illuminate the tip. However, this is not a limitation on the present invention.

[089] In a surgical procedure where a cleaning device assembly 341 is used, a separate nozzle 339b to secure the threading rod 300, as shown in

Petition 870180057245, of 07/02/2018, p. 41/61

36/52

FIG. 48, is also preferably used. In use, after the cleaning device assembly 341 has been used to clean the area around the access locations, the cleaning device assembly 341 is unscrewed from the instrument coupling 364 and then the nozzle 339b is screwed on. The nozzle 339b includes an o-ring 335 on it to help secure the threading rod 300 when inserted into opening 339c and the female receiver 366, as shown in FIG. 48. In another embodiment, nozzle 339b can be omitted. In yet another embodiment, the nozzle 339b may include means for tightening the threading rod therein, so that it is difficult to remove the threading rod. For example, nozzle 339b can include a set screw, chuck, interior threading or the like.

[090] As shown in FIGS. 48 and 49, in another preferred embodiment, the threading rod 300 may include fixing channels 343 defined circumferentially around it. When inserted into the nozzle 339b or the female receiver 366, one of the channels 343 receives the o-ring 335, to help fix the threading rod 300 on it. The grooves are located close to both ends because the threading rod is reversible, as described below. In another embodiment, instead of an o-ring, the nozzle 339b or the coupling 364 of the instrument (see FIG. 50) may include a metal ring 345 which is received in the channels 343, which provides a stronger snag than the o-ring.

[091] It will be understood that the length of the threading rod 300 will change, depending on the type of procedure being performed (and the size of the anatomy of the

Petition 870180057245, of 07/02/2018, p. 42/61

37/52 patient). It is important that the threading rod 300 is long enough so that, when passed through the subcutaneous route, while one end emerges from an exit access point 14 the other end extends outside the entry access point 14. For example, in percutaneous trampoline platysmaplasty, the threading rod 300 can be approximately nine inches long. Referring to FIG. 53, this allows one end of the threading rod 300 to extend outside the access location 14b and the opposite end to extend outside the access location 14c simultaneously. In MACS-lift, the threading rod 300 does not have to be that long. It should be understood that the threading devices 100 and 300 shown in the figures are not for scale.

[092] With reference to FIGS. 57 and 58, in the other embodiment, the threading rod can be bent or bent. For example, As shown in FIG. 57, the ends 304 can be curved in different directions. This type of threading rod 300a can be solid or can have a light guide on it. The ends can be sharp or blunt. In the mode with sharp edges, it can be difficult to transmit light through the ends 304, so an opening 347 can be made in the tube 307 to allow the light to be emitted from a point spaced from the end 304. The threading rod 300a can be useful for abdominal surgery and can be thick and less malleable than the modalities described above to strengthen the device. As shown in FIG. 58, in another embodiment, the threading rod 300b may have ends that curve in the same direction.

Petition 870180057245, of 07/02/2018, p. 43/61

38/52 [093] An exemplary construction of a support matrix 200 using threading device 100 will now be described. For example, as shown in FIG. 15, after the first end 150a of the suture 150 is connected to the eyelet 102, the hand device 60 is grasped by the surgeon and the threading device is introduced through a first port of the skin 80a. The illuminated tip 104 of the threading device 100 illuminates the work area and transilluminates through the skin allowing the surgeon to determine the proper placement of the support matrix 200 and the position of the tip 104. As described above, in a preferred embodiment, the port 80 is unobstructed to assist the passage of the threading device 100. That is, when the tip 104 of the threading device 100 comes close to port 80, it will transilluminate.

[094] The threading device 100 is preferably long enough that it can be threaded from one side of the jaw line to the other such that the tip 104 is brought out through a second port of the skin 80b on the opposite side of the jaw from which it was introduced. At this point, tip 104 is grabbed by the surgeon and suture 150 is pulled through the area under the

neck. So the device threading 100 is disconnected from hand device 60 allowing that the device threading 100 e the suture 150 if already am pulled through from the second port skin 80b, how is it shown in FIG. 16.

[095] The threading device 100 is then rotated and reconnected to the handheld device 60 and is then reintroduced through the second skin port 80b and

Petition 870180057245, of 07/02/2018, p. 44/61

39/52 passed subcutaneously to the contralateral side exiting through the third port of skin 80c. The threading device 100 is again disconnected from the handheld device 60 and is reconnected after the threading device and suture 150 are pulled through the third port of the skin 80c.

[096] Then, the threading device 100 is rotated and reconnected to the handheld device 60 and then it is reintroduced through the third port of the skin 80c and passed subcutaneously to the contralateral side exiting through the fourth port of the skin 80d. At this point, the threading device 100 is again disconnected from the handheld device 60 and is reconnected after the threading device and suture 150 are pulled through the fourth port of the skin 80d.

[097] The threading device 100 is then rotated and reconnected to the handheld device 60 and then is reintroduced through the fourth port of the skin 80d and passed subcutaneously to the contralateral side exiting through the fifth port of the skin 80e. At this point, the threading device 100 is again disconnected from the handheld device 60 and is reconnected after the threading device and suture 150 are pulled through the fifth port of the skin 80e.

[098] Then the threading device 100 is rotated and reconnected to the handheld device 60 and then it is reintroduced through the fifth port of the skin 80e and is passed subcutaneously to the midline submental access site which preferably includes a threaded skin port 120 (described in more detail

Petition 870180057245, of 07/02/2018, p. 45/61

40/52 here below). The threading device 100 and the first end 150a of the suture 150 are pulled through the port of the skin 122 and the threading device is disconnected from the hand device 60. The first end 150a of the suture 150 is then cut from and / or untied from the threading device 100.

[099] Now, the second end (or the distal end) 150b of suture 150, which is extending from the first port of the skin 80a is fixed to the hole 102 of the threading device 100 and the threading device 100 is connected to the hand device 60. The hand device 60 is seized by the surgeon and the threading device is introduced through the first port of the skin 80a and is passed subcutaneously to the contralateral side exiting through the sixth port of the skin 80f. At this point, the threading device 100 is again disconnected from the handheld device 60 and is reconnected after the threading device and suture 150 are pulled through the sixth port of the skin 80f.

[0100] Then, the threading device 100 is removed and reconnected to the handheld device 60 and then it is reintroduced through the sixth port of the skin 80f and is passed subcutaneously to the contralateral side exiting through the seventh port of the skin 80q. At this point, the threading device 100 is again disconnected from the handheld device 60 and is reconnected after the threading device and suture 150 are pulled through the seventh port of the skin 80q.

[0101] The threading device 100 is then removed and reconnected to the handheld device 60 and then

Petition 870180057245, of 07/02/2018, p. 46/61

41/52 reintroduced through the seventh port of the skin 80f and is passed subcutaneously to the contralateral side exiting through the eighth port of the skin 80h. At this point, the threading device 100 is again disconnected from the handheld device 60 and is reconnected after the threading device and suture 150 are pulled through the eighth port of the skin 80h.

[0102] Then, the threading device 100 is rotated and reconnected to the handheld device 60 and then it is reintroduced through the eighth port of the skin 80h and is passed subcutaneously to the port of the skin 120 threaded at the sub-access site mentonian in the midline. The threading device 100 and the second end 150b of the suture 150 are pulled through the threaded skin port 120 and the threading device is disconnected from the handheld device 60.

[0103] As will be understood by those skilled in the art, tube 84 in skin ports 80 is long enough that when the threading device

100 is inserted into the suture 150 will anchor surrounding the facial ligaments maintained during the procedure described above. Preferably, each time the threading device 100 and the suture 150 are passed through a port 80, the suture is attached to the maintained facial ligaments, thereby creating an anchor or pivot point.

[0104] It will be understood that the number of access points 14, ports 80 and / or passages, etc. described above are merely exemplary and any number can be used in the procedure currently described, according to the requirements

Petition 870180057245, of 07/02/2018, p. 47/61

42/52 of private surgery.

[0105] The transcutaneous transmission of light from tip 104 of the threading device 100 responds by allowing the surgeon to determine the position of tip 104 while supporting matrix 200 is woven and created. This response allows the placement of each individual wire relative to the necessary support areas. This allows suture 150 to be placed adjacent to the muscle, deep into the skin and fat layers.

[0106] Preferably, at each port 80, the end of the tube 84 which is associated with the protruding edge 82 has a beveled or tapered edge 84a, which helps to prevent the tip 104 of the threading device 100 from gripping inside the tunnel 86, during insertion.

[0107] In another embodiment, two threading devices 100 that are connected each to an opposite end of the suture 150 can be used. In this embodiment, the first threading device 100 does not have to be disconnected from the end of suture 150 before the second end of suture 150 is threaded through the skin. In yet another embodiment, the suture 150 may come in a kit with the two disposable threading devices 100 attached to the opposite ends 150a and 150b. After forming matrix 200, threading devices 100 can be cut from suture 150 and then the suture can be tied.

[0108] FIGS. 19-23 show the threaded skin port 120 used for the sub-mentonian access site on the midline. The threaded skin port 120 is introduced at the same time as the skin port 80 described above.

Petition 870180057245, of 07/02/2018, p. 48/61

43/52

However, this is not a limitation on the present invention. Port 120 includes a projecting edge 122 which has a tube 124 extending therefrom. Tube 124 is preferably threaded 126. As shown in FIG. 22, tube 124 and projecting edge 122 collaborate to define a tunnel 128 through it. In a preferred embodiment, the tunnel portion 128 at the protruding edge 122 includes a beveled or tapered edge 128a.

[0109] In a preferred embodiment, port 120 includes a pair of cable portions 130 that extend upward from protruding edge 122 which assist the surgeon in screwing port 120 at the sub-mentonian access site on the midline. However, cable portions 130 are not a limitation in the present invention and can be omitted. Any port of the skin that allows access through the skin will be understood to be within the scope of the present invention. For example, skin port 80 or the like can be used at the sub-mental access site on the midline. In another embodiment, port 120 can be used at access point 14. In a preferred embodiment, port 120 is unobstructed to assist the passage of the threading device 100. That is, when the end 104 of the threading device 100 arrives near port 120 it will transilluminate.

[0110] In use, tube 124 is introduced at the sub-mental access site of the midline. The portions of the cable 130 are gripped and the port 120 is rotated so that the threads 126 are threaded on the skin until the lower surface of the protruding edge 122 rests in front of the external surface of the skin.

Petition 870180057245, of 07/02/2018, p. 49/61

44/52 [0111] In another embodiment, a port similar to the port of skin 80 described above, but somewhat modified can be used for access in the midline. In this embodiment, the projecting edge includes a threaded interior that engages the threads on the outside of the tube. The distal ends of the folding elements are connected to a ring that is not internally threaded. This ring allows the tube to rotate in it, but (because it is not internally threaded) it prevents the ring from mounting above the tube's threads. The opposite ends of the folding elements are connected to the projecting edge.

[0112] With this configuration, when the tube is rotated (preferably by coupling with the handheld device or with the surgeon's fingers), the threaded coupling from the outside of the tube to the inside of the protruding edge causes the tube to move externally (in relation to the inside of a patient's body). This action causes the folding elements to fold in the fold. In use with a patient, in the folded position, the proximal end of the tube is located outside the patient's body, and the distal end moves closer to the protruding edge than it was in the unfolded position.

[0113] With reference to FIGS. 18-20, an instrument that positions node 140 is shown and described. After both ends 150a and 150b of suture 150 are threaded and support matrix 200 is created, the two ends 150a and 150b of the suture are brought out through the sub-mentonian access site on the midline (through port 120 ), as shown in FIG. 19. A single launch node 150c is placed (will be understood

Petition 870180057245, of 07/02/2018, p. 50/61

45/52 that the type of knot is not a limitation in the present invention) and the instrument that positions knot 140 is used to adjust knot 150c.

[0114] One end 142 of the instrument that positions the knot 140 (which is preferably threaded) enters with the hand device 60 and the other end 144 is forked. The forked end 144 is used to push the knot 150c through tunnel 128 of the threaded skin port 120 and under the skin. In a preferred embodiment, the instrument positioning the node 140 includes an optical fiber core 152 and an opening 152a through which light is transmitted to illuminate the work area when placing the node 150c.

[0115] After the knot 150c has been pushed through the threaded port 120, the threaded port 120 is twisted out of the access location and the other skin ports 80 are removed using the handheld device 60. To do this, the male connector 68 is introduced into port 80 so that the ridge 68a fits into the indented ring 82a and the teeth 68b and 82b engage with each other. The hand device 60 is then twisted, thus turning the tube 84 and causing the internally threaded ring 90b to travel back down the threads 88 and unfolding by folding the folding members 90a. In another mode, ports 80 can be removed by hand.

[0116] After the atraumatic removal of ports 80 and 120, the steristrips are then placed as desired and a neck compression garment is fitted to the patient.

See FIG. 25 for the final configuration of the exemplary support matrix 200.

Petition 870180057245, of 07/02/2018, p. 51/61

46/52 [0117] Another exemplary embodiment of the construction of a support matrix 200 will now be described. Please see FIGS. 46 - 51. In this embodiment, handheld device 360 and threading device 300 are used. In this example, as shown in FIGS. 51-56 most access sites 14 are above the submandibular border. Because the threading device 300 is generally straight and needs to travel around the curvature of the jaw, it requires intermittent access locations 14 under the jaw to allow the threading rod to be redirected around the curvature of the neck (the exemplary access location that shows this is marked as 14a). The surgeon may choose to use other access locations under the patient's jaw or in other locations, as needed, to allow the threading rod to be redirected.

[0118] As shown in FIG. 51, before using the threading device, the surgeon may want to use the cleaning device 321 (or cleaning device assembly 341) to clean skin accessories under the area adjacent to the access points 14. Although not shown in FIGS. 51-56, the surgeon can also use the nozzle 339 or 339b to help secure the threading rod 300 and assist in handling the handheld device 360 during surgery.

[0119] For the initial entry of the threading device 300 and the first suture 150 the surgeon creates an access site 14a under the chin. The handheld device 360 is illuminated (for example, pulling the torn cord, twisting or pushing the tail cone or otherwise connecting the light source) and the threading device 300

Petition 870180057245, of 07/02/2018, p. 52/61

4Ί / 52 is inserted into the handheld device 360. The threading device 300 is introduced through the access location 14a, as shown in FIG. 52. The illuminated tip 304 of the threading device 300 illuminates the work area and transilluminates through the skin allowing the surgeon to determine the appropriate placement of the support matrix 200 and the location of the tip 304.

[0120] The threading rod is then brought out through a second access site 14b and a portion of the suture is pulled through the second access site 14b. Sufficient suture is pulled through the second access site 14b so that only enough suture is still projecting out of site 14a so that the suture can be tied off at the end of the procedure (described below). To prevent the end of the suture from being pulled through the first access site 14a it can be anchored by something, such as a hemostat. It will be understood that because the suture is tied in the middle of the threading stem 300, the surgeon does not have to pull the entire threading stem out of the access site. Alternatively, after more than half of the threading stem is pulled through the site and the suture is pulled through, the surgeon can rotate the stem in the desired direction and then start pushing the stem back through the access site. This action allows the suture to anchor in the ligaments under the skin near the access points. It will be understood that because the threading rod 300 has the suture attached close to its half and has two ends, it does not have to be rotated each time it is brought out from under the patient's skin. However, the

Petition 870180057245, of 07/02/2018, p. 53/61

48/52 surgeon can turn the threading rod around as desired.

[0121] Before pushing the threading rod back to the second access point 14b, the surgeon places the handheld device on the end of the threading rod to illuminate the tip 304, as shown in

FIG. 53.

[0122] The threading rod is then threaded from site 14b to site 14a, rotated and passed subcutaneously to the third access site 14c. Depending on the patient, the surgeon may thread in a straight line from location 14b to location 14c without rotating the stem in 14a. This is repeated for the fourth, fifth and sixth access sites 14d, 14e and 14f and eventually the threading rod is brought out through the sub-mentonian access site (each time, the surgeon does not always have to go back to out through location 14a but can go directly to the next location in the shoelace). It will be understood that the handheld device is removed and placed on the threading rod as desired during this procedure so that one of the tips 304 is illuminated as desired. Suture 150 is then cut from the threading rod. Preferably, each time the threading device and suture 150 are passed through an access point 14, the first suture 150 is passed around the facial ligaments held adjacent to it, thereby creating an anchor or pivot point.

[0123] As shown in FIG. 54, a second suture

151 is then attached to the threading rod 300 and the threading rod is introduced at the first access point

Petition 870180057245, of 07/02/2018, p. 54/61

49/52

14a. It is then passed subcutaneously to the seventh 14g access site. Similar to the procedure described above for the first suture 150, the second suture 151 is then threaded at the eighth, ninth, tenth and eleventh access locations 14h, 14i, 14j and 14k (see FIG. 55) and is finally brought out of the sub-mentonian access site on the midline. The ends of sutures 150 and 151 extending out of site 14a are then tied together, thereby completing the matrix 200 (see FIG. 56). The knot 150c is then pushed through site 14a and under the skin (for example, using the cleaning device or the threading rod). At this point, the surgeon can pull the ends of sutures 150 and 151 that extend out of the submental access site to place the desired tension in matrix 200. Once this is done, the ends of sutures 150 and 151 are tied together and the knot 150c is pushed through the spot and under the skin.

[0124] It will be understood that surgery can be performed without the hand device. Some surgeons may want to use the threading device alone without using the handheld device to illuminate the tips. In this situation a continuous threading device or a threading device with independent sources of energy and light can be used. It will be better understood that the threading device 300 can be used for other types of surgery. For example, it can be used to place the suture systems that are generally used in plastic surgery that previously requires the opening or elevation of the skin on the face, neck and / or other areas of the body. Examples of this include using this device or

Petition 870180057245, of 07/02/2018, p. 55/61

50/52 system for placing a suture that defines the neck or can be used in MACS-lift (minimal access cranial suspension), which is described in The MACS-lift Short Scar Rugasectomy by Patrick Tonnard, MD and Alexis Merpaile, MD , Aesthetic surgery Journal, volume 27, number 2, pgs. 188-198, March / April 2007, which is incorporated by reference in its entirety. In this procedure, bag-string sutures are used. To place the sutures, the surgeon could use the threading rod 300 instead of making the incisions that are typically made.

[0125] The neck-defining suture, as shown in the art, is described in the article Suture Suspension Platysmaplasty for Improving Outcomes by Vincent Giampapa, MD, Ioannis Bitzos, MD, Oscar Ramírez, MD, and Mark Granick, MD, Aesthetic Plastic Surgery, Vol. 29, pgs. 341-350, 2005., which is incorporated herein by reference in its entirety. However, instead of having to make large incisions and elevate the skin under the neck, the procedure can be performed by making a small incision behind the ears and then threading the suture subcutaneously under the jaw using the 300 and necessary pivot points (access points) as desired.

[0126] In a preferred embodiment, the suture that is used in the procedure is a 4.0 braided polyester suture. In a more preferred embodiment, as shown in FIG. 24, the suture model contains at least one 150d optical fiber thread interlaced with non-optical fiber threads. Suture 150 is braided as is known in the art with one, two or three fiber optic threads and one or two threads

Petition 870180057245, of 07/02/2018, p. 56/61

51/52 that are not fiber optic, as desired. This helps in the transillumination of suture 150 to verify subcutaneous placement after suture 150 has been placed. The fiber optic wire 150d will illuminate when the fiber optic light from the handheld device 60 coupled with the knot-laying instrument 140 approaches the suture while it is tied. The light transmitted to the suture allows the surgeon to visualize the placement of the support matrix 200 while it is fixed. Yarns that are not fiber optic can be made of any material known in the art, such as nylon, polypropylene, or other non-absorbable material.

[0127] At any point during the creation of the support matrix 200, the placement of the suture can be confirmed by placing the handpiece 60 or 360 (or any light source) at one end 150a or 150b of the suture 150, thus transmitting light down the 150d fiber optic wire to check the placement of the suture

150.

[0128] Lighting the suture path allows the surgeon to determine the location of the suture. In general, lighting the suture gives the surgeon the answer in relation to the anatomical movement of each pivot point.

[0129] It will be appreciated by those skilled in the art that fiber optic suture can be used in all areas of surgery or other materials where an illuminated bonding material is required, and not just in the technique described here. In another embodiment, the threading device can be a straight or curved needle. The application of light energy during a procedure

Petition 870180057245, of 07/02/2018, p. 57/61

52/52 surgery will confirm the placement and accuracy of the suture. The application of light in the postoperative period could allow surgeons to understand the evolution of the suture placement in relation to time and aging.

[0130] In an alternative modality, the skin of the neck can be lifted from the platysma muscle through an incision similar to that used in the standard procedure discussed above to allow the surgeon to visualize the operative field and then the suture matrix can be placed through the ports 80 and / or access locations.

[0131] It is contemplated that the instruments described above can be sold in kits. For example, a kit with all or any combination of instruments, including tape 10 or 310, a marking pen, lancet 40, hand device 60 or 360, skin ports 80, threading device 100 or 300, skin port Threaded 120, instrument that positions the knot 140, suture 150 or 151, nozzle 339 or 339, cleaning device 321, cleaning device set 341 or any other instrument described here can be sold.

[0132] The embodiments described above are exemplary embodiments of the present invention. Those skilled in the art can now make numerous uses, and departures from the modalities described above without departing from the inventive concepts disclosed here. Therefore, the present invention is to be defined solely by the scope of the following claims.

Petition 870180057245, of 07/02/2018, p. 58/61

1/2

Claims (10)

1. Threading device (300) for suturing, the device characterized by the fact that it comprises: a) an elongated tube (307) having the opposite first and second ends, an interior and a location for fixing the suture, where at least one of the first and second ends of the elongated tube includes a blunt end (304), where the blunt end is translucent, and b) a light guide (306) extending through the interior of the elongated tube (307), through which the translucent tip is illuminated when the light guide (306) is energized. Threading device according to claim 1, characterized in that the diameter of the elongated tube (307) at the first end or close to the first end is approximately the same as the diameter of the elongated rod at the second end or close to the second far end. 3. Threading device according to claim 1 or 2, characterized by the fact that the suture fixation site is defined approximately in the longitudinal center of the elongated tube (307). Threading device according to any one of claims 1 to 3, characterized in that it further comprises a suture (150) permanently attached to the suture fixation site. Threading device according to any one of claims 1 to 3, characterized in that the suture fixation site comprises a groove (303) that extends at least substantially circumferentially Petition 870180057245, of 07/02/2018, p. 59/61 2/2 around the outside of the tube (307). Threading device according to one of claims 1 to 3 or 5, characterized in that it additionally comprises a suture (150) received in and covered around the suture fixation site. Threading device according to any one of claims 1 to 6, characterized in that both the first and second ends of the elongated tube include a blunt end (304), where each blunt end is translucent. 8. Threading device according to claim 7, characterized in that the first and second ends are arranged so that, in use, light transmitted through one of said ends is transmitted through the light guide (306 ) and out at the other of said ends. Threading device according to any one of claims 1 to 8, characterized in that the light guide (306) has the first and second ends and where the first and second ends of the light guide (306) ) are substantially aligned with the first and second ends of the tube. Threading device according to any one of claims 1 to 9, characterized in that the suture (150) extends circumferentially around the tube (307) and the light guide (306). Petition 870180057245, of 07/02/2018, p. 60/61 1/32