BRPI0720186A2 - NECK LIFTING PROCEDURE AND INSTRUMENTS FOR RUNNING THERE - Google Patents

Description

NECK LIFTING PROCEDURE AND INSTRUMENTS FOR

RUN THE SAME

Field of the invention

The present invention relates generally to methods and devices for plastic surgery and more particularly to a minimally invasive neck lift procedure and instruments for performing the procedure.

Background of the Invention Conventional Rejuvenation Surgeons

Neck advocate procedures that alter the anatomy of the neck to regain a younger contour of the neck. These involve manipulation of the platysma such as muscle advancement and / or division, and often the excision of 15 fat from below the platysma. Partial resection of submandibular gland 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 divista muscle, or exaggerated fat resection.

Plastic and reconstructive surgeons have long sought to develop methods and devices to assist in sustaining physical structures that have lost their tensions and natural 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 look of the structure to prevent such loss of tension in these structures. The aging process causes gradual and predictable changes 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 5 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 "ligature", often resulting in submandibular gland ptosis. Additional loss of tone and muscle atrophy result in the joining of medial platysma edges, attenuation of the cervicomental angle, and loss of lateral mandibular definition.

The failure of the classic neck lift to properly treat the consequences of neck aging has led to the development of a number of modifications and adjunctive procedures. These include skin excisions, various lipoplasty techniques, anterior or posterior platysma-based transection, resection or plication procedures, SMAS-platysma flaps, and suspension suture techniques. However, these modifications have their limitations.

Problems with scar contractions and hypertrophic scarring resulted in the almost abandonment of

2 5 midline skin with subsequent Z, W or T-plasty. THE

Liposuction or direct liposculpture has an important role in aging the neck.

Summary of preferred embodiments

In accordance with a first aspect of the present

In the invention, a method is provided for threading a suture into a patient's body. The method includes the steps of providing a suture, providing a threading device comprising an elongated stem having a local tie-off 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 stem subcutaneously to a second opening in the patient's skin by pulling the first end of the elongated stem and a portion of the suture through the second opening without rotating the elongate rod around, and passing the second end of the elongate rod subcutaneously to an opening in the patient's skin. At at least one point during the method the first end of the elongate rod extends out of the first aperture and the second end of the elongate rod extends through the second aperture. In a preferred embodiment, the first and second ends of the threading device are each illuminated in

20 predetermined points during the method.

According to another aspect of the present invention, a method of performing the surgery is provided. The method includes the steps of placing a tape mold on a portion of a patient's skin, marking a plurality of access sites 25, making an opening to form an access line in the midline, performing liposuction, forming a plurality of openings. into the skin at the access points by providing a threading device that has a suture attached thereto, and introducing the

Threading and suturing through a plurality of access sites to form a suture matrix under the skin.

According to yet another aspect of the present invention there is provided a surgical kit comprising at least two of the following: at least one tape element, a lancet, a handheld device, a cleaning device, a nozzle, a threading, and a suture. In a preferred embodiment, the hand-held device includes a tubular member having first and second opposites, an instrument coupling extending from the first end of the tubular member including an aperture for receiving a rod and a light source, where light The light source is directed out of the opening in the instrument coupling. The threading device preferably includes an elongate stem having a defined groove therein extending at least substantially circumferentially around the stem and blind ends. The threading device preferably also includes an elongate tube having first and second open ends and a local tie-off suture disposed approximately midway between the first and second ends, and a light guide passing through the elongate tube. The light guide has 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 having at least two perforations defined therethrough, and a second layer overlying the first layer having at least two perforations defined therethrough. At least one of the perforations of the second layer at least partially overlaps at least one of the perforations of the first layer. The cleaning device preferably includes a neck and a neck cleaning portion that extends from the neck in a curved path defining a plane which is approximately perpendicular to the longitudinal axis of the neck.

Brief Description of the Figures

The invention may be more readily understood by referring to the accompanying drawings in which:

FIG. 1 is a perspective view of a mold

tape according to a preferred embodiment of the present invention;

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

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

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

20 3;

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

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

FIG. 7 is a sectional side elevational view of the handheld device of FIG. 5 showing the fiber optic core;

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

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

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

FIG. 10 is a sectional view showing the port of

skin introduced into a patient's skin after unfolding;

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

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

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

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

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

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

FIG. 17 illustrates the threading device of the

FIG. 13 passing through the subcutaneous facial ligaments and neurovascular structures.

FIG. 18 is a top side view of a node positioning instrument 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 midline sub-mentonal access site and a suture knot extending there;

FIG. 20 is a cross-sectional view of the instrument that positions the node of FIG. Pushing the knot through the port of the threaded skin and under the skin of a patient;

FIG. 21 is a side top view of a threaded skin port in accordance with a preferred embodiment of the present invention;

FIG. 22 is a sectional side elevational 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 suture.

fiber optic cable 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 molding according to a preferred embodiment of the present invention;

FIG. 27 is a view of the laminated tape mold of FIG. 26 being used to mark the puncture sites on the

2 the chin of a patient;

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 device of FIG. 28;

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

FIG. 31 is an end view of the handheld device of FIG. 28;

3 FIG. 32 is a detailed perspective view of another preferred embodiment of the handheld instrument coupling of FIG. 28;

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

FIG. 34 is a cross-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 device.

of FIG. 28;

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

FIG. 36 is a perspective view of a device.

threading in accordance with a preferred embodiment of the present invention;

FIG. 37 is a detailed top 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 detailed top view of a portion of a threading device including a hole;

FIG. 40 is a partial section elevation of one

2 5 threading device with one power source and one

independent light sources according to another preferred embodiment of the present invention;

FIG. 41 is a perspective view of a threaded rod according to a preferred embodiment of the

30 the present invention; FIG. 42 is a detailed perspective view of the threading rod of FIG. 41 showing the groove;

FIG. 43 is a sectional elevation of one end of the threaded rod of FIG. 41 taken along lines 4-43 of FIG. 41;

FIG. 44 is a perspective view of the threading device of FIG. 36 introduced into a handheld device;

FIG. 45 is a section elevation made along the

line 45-45 of FIG. 44;

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

FIG. 47 is a top cross-sectional view of a

hand-held device with a cleaning device assembly therein according to another preferred embodiment of the present invention;

FIG. 48 is a partial cross-sectional top view of a

20 The handpiece with a nozzle thereon according to a

another preferred embodiment of the present invention;

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

FIG. 50 is a partial cross-sectional top view of a

hand-held device with the threaded rod of FIG. 4 9 fixed on it;

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

3 FIG. 52 is a view of a patient showing insertion of the threaded rod and first suture into the access site 14a using the handheld device;

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

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

FIG. 55 is a patient's view showing the

insertion of the threaded rod and second suture into the access site 14g after turning the threaded rod;

FIG. 56 is a patient view showing the final placement of the two-suture support matrix before the knots are pushed through the access sites;

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.

Similar numbers refer to similar parts by the various views of the drawings.

Detailed Description of Preferred Embodiments Described herein are preferred embodiments of a

technique for placing a suture on a person's body. The technique is preferably used in the field of plastic surgery and involves several steps in which each requires specific instrumentation.

For exemplary purposes only, preferred embodiments are described below where the technique and instruments of the present invention are used to perform a NECK LIFTING, referred to herein 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 may be used as desired by one of ordinary skill in the art.

The liposuction part of the procedure is performed without a large incision under the chin. The placement of the suture support matrix 10 is performed through several small access points in the neck area under the jaw. The advantage is that the entire support system can be placed without the typical large incision under the chin that is required 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.

Exact placement of the support suture (s) (also referred to herein as the support structure or support matrix 200, and shown in Figures 25 and 56) will be described herein together with the description of each of the instruments. or the individual devices that may be used in connection with such a procedure.

As described above, the inventive aspects of the present invention involve the placement of the support matrix 25,200 and not the actual liposuction technique. Accordingly, it will be understood that any references to liposuction techniques herein are exemplary only.

It will be appreciated that terms such as "front," "back," "top," "bottom," "side," "right," "left," "up" and "down" used herein are for ease of description only. 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 components thereof described herein are within the scope of the present invention.

Referring to FIGS. 1-2, the ribbon (or ribbon elements) 10 will be described. In a preferred embodiment, tape 10 is a piece of clear tape with 10 perforations 12 therethrough that 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 one exemplary embodiment, tape 10 is a one inch wide clear tape with approximately 2 millimeter circular perforations 12 defined therethrough, 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, but this is not a limitation in the present invention. In another 20 mode, tape 10 is not clear. In a preferred embodiment, tape 10 is provided in roll form. However, this is not a limitation on the present invention.

Tape 10 is used in immediate preoperative planning to determine placement of access points 25 14, which will determine the placement of support matrix 200. Tape 10 is used as a guide to help provide proper positioning of each suture and corresponding pivot point (as described below). Perforations 12 are used to mark access points 14 for surgery. In a preferred embodiment, the first and second tape members 10 are placed on either side of the skin overlying the lower jaw surface as shown in FIG. Preferably, the tape 10 is used with the patient sitting vertically, 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 the plurality of perforations 12 to develop a surgical approach that is tailored 10 individually to 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.

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

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 suture placement to elevate the soft tissue of the neck. In a preferred embodiment as shown in FIGS. 2 and 5, markings 14 made using the first tape element 10 are symmetrical to markings 14 made using the second tape element 10.

As will be described below, each of the markings 14 defines a position or an access site that will be punctured to allow subcutaneous access there. For simplicity, as each access point is marked and then punctured, the access points, markings and punctures will all be marked here.

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, multiple suture strands will be required. While each area to be raised is recognized, a corresponding perforation 12 of the tape is marked 14 to insure that the suture placement is accurate.

As shown in FIGS. 26-27, in another preferred embodiment 20, tape 310 may be laminated. Laminate tape 310 preferably includes two layers 311 and 313. As shown in FIG. 26, upper layer 313 has a set of holes or perforations 313a and 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 in marking the patient.

As described below, the support die 200 is formed similar to the way a shoelace is passed through a shoe. Therefore, in marking the skin for access points 14, it may be useful to mark the skin with two different colored markers, for example 5 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 (each having an access site 14 formed therein, as described 10 below).

In use, the surgeon positions the laminated tape 310 as desired and marks the perforations (concentric or double perforations 311a and 313a) with the first color. The surgeon then peels the first or topsheet 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. Tape 310 may also be configured in roll form. In another preferred embodiment, a single piece of tape 310 may be used extending around the entire jaw line or other position in the body. This helps to align the markings on each side.

It will be understood that tape 10 or 310 is preferably used prior to performing liposuction or another desired procedure. However, this is not a limitation on the present invention. In another embodiment, the tape may be used after liposuction is performed. In another embodiment, the tape may be omitted and the surgeon may mark or puncture the skin as desired.

It will be appreciated by those skilled in the art that tape 10 or 310 may be worn on areas of the body other than the chin. For example, the tape (and the rest of the procedure described below) can be used for either a face Iift or MACS-Iift or when placing a 5-point suture around the neck (both described below).

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 markings 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 subentonian access point on the midline) is made in this area. 0 liquid

Tumescent is injected into the entire area under the chin, including the neck region. Liposuction is performed throughout the region. Upon completion, the area is infiltrated once again with tumescent fluid. This subcutaneous infusion results in elevation of the skin of the platysma muscle.

With reference to FIGS. 3-5, upon completion of the

With liposuction, the patient is ready for placement of the support matrix 200. A lancet 40 is used to create access sites 14 by puncturing the dermis at the marked points using tape 10 or 310.

As shown in FIG. 3, the lancet 40 includes a

blade 4 2 which has two sharp edges 4 3 ending in a point 44 with two blind edges 46 below. In a preferred embodiment, the blade 42 is approximately 8 millimeters long. Blind edges 4 6 of blade 4 2 extend from

30 is a protruding edge or stop member 48 that prevents the blade 42 from going deeper into the skin than desired. The protruding edge 48 ensures consistent depth of blade penetration. Also, the blade 42 is sized to allow placement of the skin ports 80 as described below.

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 stopping element 48. As shown in FIG. 3, the two sharp edges 4310 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.

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 down from the second ends 43b of the two sharp edges 43. The sharp edges 43 and the blind edges 46 meet at an obtuse angle. The second ends 46b of the two blind edges 46 are connected to the stop element 48, which in a preferred embodiment is disc-shaped. However, this is not a limitation on the present invention. In an alternative embodiment, the blade 42 may extend from the stopping element 48 at a non-right angle (e.g., an acute angle).

In a preferred embodiment, the lancet 40 includes an accessory member 50 extending below the lower surface 48b of the stopping member 48 and allows the lancet 40 to be attached to a standard scalpel handle 52. In another embodiment, the lancet 40 may be provided with a single cable.

The subcutaneous infusion described above results in elevation of the skin of the platysma muscle. Once infiltrated, access sites 14 are developed by puncturing skin 5 with percutaneous lancet 40 at the markings developed using tape 10, as shown in FIG. 5. Lancet 40 allows puncture of the skin to gain access to the neck region and preferably ensures that each access site is as small as possible, allowing

support system placement 200.

It will be understood that in a preferred embodiment, the lancet 40 creates punctures rather than incisions, which minimizes trauma and the risk of scarring. However, the incisions may be used in another mode.

Referring to FIGS. 6-7, the next instrument used

in the procedure it is a handheld device or a cable 60. Handheld 60 is incorporated into a reusable insertion device with an instrument coupling 64 at one end thereof. In a preferred embodiment,

20 The handheld 60 also includes a light port.

fiber optic 62. In a preferred embodiment, the handheld device is ergonomically designed to fit the hand of the surgeon when held. However, this is not a limitation on the present invention. Preferably, the

Handheld 60 is made of a metal, such as stainless steel or titanium. However, it may be made of other materials, such as a plastic or the like. As described below, instrument port 64 is compatible with a number of instruments that are used

30 in the surgical procedure of the invention. The frame design and shape allows the ability to switch from right to left hand easily and accurately.

In a preferred embodiment, the instrument coupling 64 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 illumination. The coupling 64 of the instrument is adapted to couple with certain instruments, as will be further described below. Handheld 60 will be described more fully below in conjunction with the instruments with which it is intended to be used.

Fiber optic light port 62 allows docking to a fiber optic light cable (not shown). Transmission of fiber optic light through handpiece 60 illuminates each device when it is attached to the working end of the instrument coupling 64.

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

In another mode other types of lighting.

can be used. For example, LED, incandescent, fluorescent and other light sources may be used. However, it will be understood that light transmission is not a limitation in the invention. Handheld 60 (and 30 associated instruments) may be provided without a fiber optic core.

Referring to FIGS. 28-34, another embodiment of a handheld device or lighting device 360 is shown. In a preferred embodiment, the handheld 5 360 is battery operated and disposable.

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 (more fully described below). Preferably the 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 socket 361) is generally tubular. That is, it does not have to have a circular cross section; It can be square, oval or otherwise.

In a preferred embodiment, the handheld 360

It is supplied with 3 63 batteries 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 herein as a breakaway cord or breaker 369) may be inserted between two batteries 363 to keep the circuit open and is then removed for a suitable time to allow electrical communication. between the batteries, thereby closing the circuit and lighting the light source 365. As 30 shown in FIG. 29, the socket preferably has a groove 371 defined therein through which the breaking cord 369 extends.

In use, when the surgeon is ready to use the handheld 360, he / she pulls the breakaway cord 5 to power the LED 365a and it will then operate for a predetermined period of time (eg 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 standard wall outlet and run on AC power.

In a preferred embodiment, the power source and light source are sealed outside the handheld 360. This helps with sterilization and prevents contamination of the work area.

In another preferred embodiment, instead of using a breakaway cord, a lock switch mechanism may be used to activate the batteries or turn on the light source. Any method for turning on the lock switch mechanism is within the scope of the present invention. For example, as shown in FIGS. 46 and 47, handheld device 60 may include a tail cone or button 337 which may be twisted or pressed to turn on the device. Or, a switch may be located within the female receiver 366. In this embodiment, when the wiper 321, the wiper assembly 341 or the threaded rod 300 (described below) are inserted into the receiver 366, the switch is turned on. and the batteries and LED are activated. For example, the ring situated next to o-ring 335 in FIG. 46 could be coupled to a magnetically activated switch.

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

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

Generally, the skin port 80 includes an edge

protruding or a cuff 82 having a tube 84 extending therefrom. One end of the tube or sleeve 84 is inserted into the punch 14 in the skin until the protruding edge 82 rests near the outer surface of the skin. The protruding edge 15 and tube 84 cooperate to define a tunnel 86 which will provide 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 does not have to be clear and it does not have to be colored.

In a preferred embodiment, handheld 60 or 360 is used to deploy each port 80 through individual access sites 14. Preferably, the skin ports 80 come in a kit, but this is not a limitation on the present invention. The 6 0 handheld design allows quick intertwining with the 8 0 skin port to remove it from the kit. It will be understood that any design that allows the handheld 60 to intertwine with or attach to the skin port 80 so that it can be implanted

30 at the access site 14 is within the scope of the present invention.

In a preferred embodiment, port 80 is fitted to male connector 68. For example, as shown in FIG. 8, male connector 68 may include a circumferentially extending ridge 68a about it cooperating with a toothed ring 82a at the protruding edge 82. Ridge 68a and toothed ring 82a provide a suitable fit such that port 8 0 is coupled with the male connector 68 of handpiece 60. Another 10 suitable fitting arrangements are contemplated.

Tube 84 is then introduced through access site 14. As shown in FIGS. 8-11, in a preferred embodiment, skin port 80 includes an anchor system comprising a thread 88 on the outer surface 15 of tube 84 and a flexible mechanism 90. Flexible mechanism 90 preferably includes a pair of flexible members 90a which they are connected to an internally threaded ring 90b which moves tube 84 up and down on the threads 88.

20 As shown in FIG. 8, the male connector 68

includes a plurality of teeth 68b at one end thereof which are adapted to engage teeth 82b in port 80. When port 80 is coupled as coupling 64 of the instrument, teeth 68b engage or engage with 25 teeth 82b. After tube 84 has been introduced through access site 14 to implement flexible mechanism 90, handpiece 60 is rotated clockwise (port 80 may be designed to rotate counterclockwise, too) . Since teeth 6 8b and 82b are coupled, the

Tube 84 rotates with handpiece 60 and within protruding edge 82, causing internally threaded ring 90b to move upward along threads 88. As can be seen from FIG. 11, the flexible members 90a include a flexible bend 90c. As the threaded ring 90b moves 5 upwardly, the flexible elements 90a bend as shown in FIG. 10, like this. providing an anchor and preventing port 80 from being pulled out of the access site 14. The flexible elements 90a may be arranged in an unfolded position (FIG. 9) and in a folded position 10 (Fig. 10).

In a preferred embodiment, the protruding edge 82 includes a plurality of downwardly extending tips 94 therefrom which engage the skin and assist in anchoring port 80 in place.

During port 80, as the

Hand 60 includes fiber optic core 70 and skin port 80 is clear, upon insertion, transcutaneous visualization of the illuminated probe tip will allow safe distribution of skin port 80. Because of the anchor system, as the handpiece 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 may use his thumb to help separate port 80 from coupling 64 of the instrument.

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. Accordingly, the type of port used is not a limitation in the present invention. Any kind of

The port providing access through the skin is within the scope of the present invention. Light transillumination gives the surgeon three-dimensional response.

As shown in FIG. 12, in an alternative embodiment, port 96 may have a tube 84 that is oriented 5 at a non-right angle with respect to the protruding edge 82. For example, tube 84 may be oriented at a 45 degree angle with respect to concerns the protruding edge.

FIGS. 13-17 show a preferred embodiment of a tapping device 100. In a preferred embodiment 10, tapping device 100 is a malleable stainless steel rod or tube that includes a rounded hole 102 defined therein, blunt end 104. Preferably , the tapping device 100 also includes a light guide 106 (which may be a fiber optic core 15) allowing illumination of the tip 104. In this embodiment, the tip 104 is preferably made of a transparent material such as a plastic which is affixed to the main body of the tapping device 100. Threading device 100 includes an end 108

20 which is designed to mate with an instrument coupling 64 or 364 of handpiece 60 or 360. In a preferred embodiment, end 108 is threaded for engagement with female connector 66, however, it will be appreciated that end 108 You can couple to the coupling 64 of the instrument in different ways. For example, the instrument coupling 64 may include a screw assembly that holds the threading device 100 in place or some type of snap or snap adjustment may be provided. In another embodiment, a clamp or mandrel, similar to that in a drill, may be used. Also, end 108 may be internally threaded and may engage with an externally threaded instrument coupling. Instrument coupling 64 permits rapid connection and disconnection with threading device 100.

In one embodiment where the handheld 60 includes a fiber optic light port 62, the end coupling 108 (including an aperture 108a thereon) with the instrument coupling 64 allows light 10 to be transmitted to the device tip 104 100. In another mode other types of lighting may be used. For example, LED, incandescent, fluorescent and other light sources may be used.

It will be understood that the hole 102 is used to secure the suture 150. The hole 102 may be located anywhere along the threading device 100.

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

FIGS. 36-45 show another embodiment of a

threading device or rod 300 including hole 302 or groove 303 (referred to herein as a local tie-off suture) at a point which is approximately intermediate between the ends thereof. As shown in FIG. 52, in a preferred embodiment, the suture 150 is tied around the threading device 300 and received in the groove 303. The groove 303 is preferably circumferentially defined around the outside of the device 300. However, in another embodiment, the groove extends only partially around device 300. Device 300 may also have an indent 305 defined therein, in which node 150c is received. This reduces the contour of node 150c and helps prevent node 150c from grabbing anything (ligaments, skin, suture, etc.).

5 when threading device 300 is used.

As shown in FIG. 38, in a preferred embodiment, tapping device 300 includes opposite ends or tips 304, tube 307, caps 304a and light guide 306. In another embodiment, tapping device 300 is

solid. In yet another embodiment, the tips and light guide may be integral or the tips may be omitted. The tapping device 300 may be solid metal without illumination or may be formed entirely of a solid (or plurality of components) made of a

translucent conductor or light conductor or transmissive material (such as plastic) so that the entire device will light up and / or so that the device will be more flexible and easier and cheaper to manufacture. It will be understood that in a preferred embodiment, the

2 0 ends or the ends of the threaded rod 300 are

blind. As used herein, blind means that the extremities do not puncture the patient's skin or any other part of the anatomy without sufficient force (a force greater than 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. Blind ends of the present tapping device 300 (whether flat or convex) do not puncture the skin when used as described

3 0 below. However, in another mode, the ends may be sharp.

In the eyelet mode, eyelet 320 can be formed such that when knot 150c is tied through it, it is received in a portion of the recess (now shown, but similar to recess 305).

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

Preferably, the tapping device 300 is malleable. For example, tube 307 may be made of stainless steel, titanium or other metal, and light guide 306 may be made of plastic (e.g. acrylic, styrene, polycarbonate or the like) or glass.

In another preferred embodiment, to make the tapping device 300 even more malleable (and easier to insert into the access points 14), the tube 307 may be tapered (or the entire tapping device 300 may be tapered in the case of a solid stem) 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 better 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 rod has a smaller diameter at the first and second ends than at the first and second positions. As shown in FIGS. 41-42, excluding groove 303, the area between first and second positions 333a and 333b has a constant diameter. This prevents stress concentration at the center of the rod 300 and helps to prevent rod failure during use. It will be understood that the first and second positions 333a and 5333b may be located anywhere along the length of the rod 300.

As shown in FIG. 36, in a preferred embodiment, the threading device 300 is not rounded. For example, it may be hexagonal. In this embodiment, a female receiver 366 of the handheld instrument coupling 364 or 360 has a corresponding shape. This prevents the threading device 300 from rotating when coupled. In another embodiment, only the ends of the tapping device 300 are polygonal. It will be understood that any way to close the threaded rod and prevent it from turning is within the scope of the present invention. Also to help prevent threading device 300 from being withdrawn from the female receiver 367, the instrument coupling may have an elastomeric o-ring 335 on it that provides a friction fit with anything inserted into it.

As shown in FIG. 38, the tube 307 is hollow and the light guide 306 passes therethrough. In a preferred embodiment, the ends 304 of tube 307 are preferably capped by end caps 30a. End caps 304a are preferably hollow, made of clear plastic and preferably include a protruding edge.

3 04b that is received on the tube 07 in a pressure adjusting arrangement. End caps 30a may also be threaded or glued to the ends of tube 307. In a preferred embodiment end caps 30a are projectile-shaped and provide total internal reflection.

As shown in FIGS. 41-43, in another preferred embodiment, tube 307 is round, and light guide 306 is flush with ends 304 of tube 307, and the recess described above is omitted. This embodiment also includes positions 333a and 333b described above. However, positions 333a and 333b may therefore be omitted, thereby providing tube 307 excluding groove 303 with a constant diameter. In this embodiment, the caps 304a are omitted. For attaching the light guide 306 to the tube 307, the light guide 306 may be packaged, 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 potted. In this embodiment, the ends 304 of the rod 300 may be cut, polished and roughened to promote light transmission and to make the ends of the tube 307 and the light guide 306 stain as shown in FIG. 43. Ends 304 may be flat or convex.

As will be appreciated by those skilled in the art, in a preferred embodiment, to promote total internal reflection in the light guide 306, the light guide 306 may be coated. If a plastic light guide is used, the outside 25 of the light guide 306 may be coated. If a glass light guide is used as is known in the art, the glass housing may 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

In use, the potted compound can slow down light transmission and make it less efficient.

When the tapping device 300 is coupled with the handpiece 360, light is transmitted through one end 304 of the rod 300, through the light guide 306, and out of the other end 304. In a preferred embodiment, the bottom of female receiver

366 has a shape complementary to that of ends 304, thereby providing efficient light transmission.

In a preferred embodiment, a high efficiency white LED is used. In this embodiment, the lighting device 360 may include a DC to DC converter to boost the voltage to the desired level for the high efficiency white LED.

It will be appreciated 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 aperture 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.

As shown in FIG. 40, in another embodiment, the tapping device 300 includes its own power source 391 and light source 393. In an exemplary embodiment, power source 391 and light source 393 (e.g., at 25 ° C). LED) can be wired 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.

In another mode, the handheld may

30 alternate the tapping device to assist in passing the tapping device through the subcutaneous route. The alternating action allows the threading device to easily pass through the adipose tissue, thus creating less collateral damage to blood vessels, nerve structures and other subcutaneous ligaments. This embodiment is similar to the cannula alternating device, which is described in United States Patent no. 6.13 9.518 to Mozsary, which is incorporated herein in its entirety by reference. In this embodiment, the hand device is powered to toggle the threading device back and forth during surgery. The threading device may be connected to the cable by a connector which is attached to, formed integrally with, or selectively connectable to an alternative element. In another embodiment, the handheld device may alternate or vibrate the threading device via ultrasound.

FIGS. 33-35b show different embodiments of the cleaning device 321, which is a blind instrument for probing the puncture or access site and clearing 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 3,23 is preferably about the same diameter as the threaded rod 300. , thus both fit into the access locations.

As shown in FIGS. 33-34, in a preferred embodiment, the cleaning portion 325 is spiral shaped. This allows the surgeon to insert the cleaning portion 325 into the access site 14 and scan the area under the clean access site by rotating the device (see FIG. 51 for a figure depicting use of the cleaning device 321).

In a preferred embodiment, the wiper 321 fits into the handheld 360. To accomplish this, the neck 323 and the coupling of the instrument 364 include the corresponding protrusions 327a and the indentations 327b, as best shown in FIG. 34. Cleaner 321 is preferably made of plastic, which allows for flexibility in the snap fit arrangement, and also allows for transiluminous cleanser 321. 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 remainder of the device is opaque. This helps direct the light to the tip. In another embodiment, the cleaning device 321 may be made of metal.

It will be understood that the cleaning device 321 may be removably attached to the handheld 360 in other ways. For example, an arrangement where a neck portion 323 is received in slots in the hand-held 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 threaded arrangement 329 is within the scope of the present invention. The cleaning device 321 may also be designed to fit into the handheld 60.

Referring to FIGS. 4-47, another embodiment of a cleaning device 321 is shown. In this embodiment, the cleaning device 321 may 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 may be closed (similar to the threading device described below 5) to prevent rotation when introduced. on the female receptor 366.

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

Referring to FIGS. 46-49, another embodiment of a handheld device 360 is shown. Handheld 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. Handpiece 360 may also include a tail cone 337 as described above. Tail cone 337 may simply be to provide the surgeon with something to hold when rotating the cleaning device or may be designed to operate a locking switch to operate the light source as described above.

In this embodiment, the device also includes a threaded nozzle 339 on the coupling 364 of the instrument. The nozzle 339 preferably includes the gripping indentations 33a and has an axially defined opening 339c that is axially aligned with the female receiver 367 when the nozzle 339 is threaded into the coupling 364 of the instrument. The nozzle 339 provides a cable 30 to the surgeon when using the handheld 360. This allows the surgeon to hold the handheld similar to the way a pen would be held.

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 wiper may be formed as a unit, thereby creating a wiper assembly 341. In this embodiment, neck 323 is inserted into female receiver 366, while nozzle 339 is threaded into coupling 364 of the instrument simultaneously. O-ring 335 helps to secure neck 323 within female receiver 366. In this embodiment, cleaning portion 325 extends in a curved path defining a plane that is approximately perpendicular to the longitudinal axis of the neck.

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

In a surgical procedure where a cleaning device assembly 341 is used, a separate nozzle 339b for securing threading rod 300, as shown in FIG. 48, is also preferably used. In use, after the wiper assembly 341 has been used to clean the area around the access points, the wiper assembly 341 is unscrewed from the instrument coupling 364 and then the nozzle 339b is screwed over. The nozzle 339b includes an o-ring 335 thereon to aid in securing the tapping rod 300 when inserted into opening 339c and female receiver 366, as shown in FIG. 48. In another embodiment, the nozzle 339b may 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 349b may include a set screw, mandrel, inside threads or the like.

As shown in FIGS. 48 and 49, in another preferred embodiment, the threaded rod 300 may include circumferentially defined locking channels 343 around it. When inserted into the nozzle 33 9b or the female receiver 366, one of the channels 343 receives the o-ring 335 to assist in securing the threaded rod 300 thereon. The channels are located near both ends because the threading rod is reversible as described below. In another embodiment, instead of an o-ring, the nozzle 339b or coupling 364 of the instrument (see FIG. 50) may include a metal ring 345 which is received in channels 343, which provides a stronger snap arrangement. than the o-ring.

It will be understood that the length of threading rod 300 will change depending on the type of procedure being performed (and the size of the patient's anatomy). It is important that the tapping rod 300 25 is long enough that, when passed subcutaneously, while one end emerges from an exit access location 14 the other end extends outside the entry access location 14 . For example, in percutaneous trampoline platysmaplasty, the

30 Threading 300 may be approximately nine inches long. With reference to FIG. 53, this allows one end of the threaded rod 300 to extend outside the access location 14b and the opposite end to extend outside the access location 14c simultaneously. In MACS-Iift,

5 the 300 threaded rod does not have to be so long. It should be understood that the tapping devices 100 and 300 shown in the figures are not to scale.

Referring to FIGS. 57 and 58, in the other embodiment, the threading rod may be bent or bent. For example, As shown in FIG. 57, the ends 304 may be bent in different directions. This type of threaded rod 300a may be solid or may have a light guide thereon. The ends can be sharp or blunt. In the sharp end mode, it may be difficult to transmit light through the ends 304, so an opening 347 may be made in the tube 307 to allow light to be emitted from a spaced end 304. The threading rod 300a may be It is useful for abdominal surgery and may be thick and less malleable than the embodiments described above for reinforcing the device. As shown in FIG. 58, in another embodiment, the threading rod 300b may have ends that bend in the same direction.

An exemplary construction of a support die 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 handpiece 60 is grasped by the surgeon and the threading device is introduced through a first skin port 80a. The illuminated tip 104 of the tapping 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 in the passage of the tapping device 100. That is, when the tip 104 of the tapping device 100 comes close to port 80, it will transilluminate.

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 skin port 80b on the opposite side of the jaw a. from which it was introduced. At this point, the tip 104 is grasped by the surgeon and the suture 150 is pulled through the area under the neck. Then the threading device 100 is disconnected from the handpiece 60 allowing the threading device 100 and the suture 150 to be pulled through the second skin port 80b as it is.

20 shown in FIG. 16

The tapping device 100 is then rotated and reconnected to the handpiece 60 and is then reintroduced through the second skin port 80b and subcutaneously passed to the contralateral side 25 exiting through the third skin port 80c. The threading device 100 is again disconnected from the handpiece 60 and reconnected after the threading device and the suture 150 are pulled through the third skin port 80c.

Thereafter, the tapping device 100 is rotated and reconnected to the handheld 60 and then re-introduced through the third skin port 80c and subcutaneously passed to the contralateral side exiting through the fourth skin port 80d. At this time, the threading device 100 is once again disconnected from the handpiece 60 and reconnected after the threading device and the suture 150 are pulled through the fourth skin port 80d.

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

Thereafter, the threading device 100 is rotated and reconnected to the handpiece 60 and then reintroduced through the fifth skin port 80e and is passed subcutaneously to the midline sub-mentary access site which preferably includes a threaded skin port 120 (described in more detail here below). The threading device 100 and the first end 150a of the suture 150 are pulled through the skin port 122 and the threading device is disconnected from the handpiece 60. The first end 150a of the suture 150 is then cut off and / or untied. of the tapping device 100.

Now, the second end (or distal end) 150b of the suture 150 extending from the first skin port 80a is attached to the hole 102 of the threading device 100 and the threading device 100 is connected to the handpiece 60. The handpiece 605 is grasped by the surgeon and the threading device is introduced through the first skin port 80a and is passed subcutaneously to the contralateral side exiting through the sixth skin port 80f. At this time, the threading device 100 is once again disconnected 10 from the handpiece 60 and reconnected after the threading device and the suture 150 are pulled through the sixth skin port 80f.

Next, the tapping device 100 is rotated and reconnected to the handpiece 60 and then reintroduced through the sixth skin port 80f and is subcutaneously passed to the contralateral side exiting through the seventh skin port 80g. At this time, the threading device 100 is again disconnected from the handpiece 60 and reconnected after the threading device 20 and the suture 150 are pulled through the seventh skin port 80g.

The tapping device 100 is then rotated and reconnected to the handheld 60 and then reintroduced through the seventh port of the skin 80f and is

2 5 passed subcutaneously to the contralateral side exiting

through the eighth port of the skin 80h. At this time, the threading device 100 is once again disconnected from the handpiece 60 and reconnected after the threading device and the suture 150 are pulled through the thread.

3 0 eighth port of the skin 80h. I

The threading device 100 is then rotated and reconnected to the handpiece 60 and then reintroduced through the eighth skin port 8Oh and subcutaneously passed to the threaded skin port 12 0 5 at the sub-mentonal access site. in the middle line. The threading device 100 and the second end 150b of the suture 150 are pulled through the port of the threaded skin 120 and the threading device is disconnected from the handpiece 60.

As will be understood by those qualified in the

In the prior art, the tube 84 in the skin ports 80 is long enough that when the threading device 100 is inserted into it the suture 150 will anchor surrounding the facial ligaments maintained during the procedure described above 15. Preferably, each time the threading device 100 and the suture 150 are passed through a port 80, the suture is fixed to the maintained facial ligaments thereby creating an anchor or pivot point.

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 may be used in the presently described procedure as required by the particular surgery.

Transcutaneous transmission of the light from the tip 104 of the tapping device 100 responds by allowing the surgeon to determine the position of the tip 104 while the holding matrix 200 is woven and created. This answer allows the placement of each individual wire relative to the required lift areas. This allows the placement

30 of suture threads 150 adjacent the muscle, deep to the skin and fat layers.

Preferably, at each port 80, the end of the pipe 84 that is associated with the protruding edge 82 has a beveled or tapered edge 84a, which helps to prevent the tip 104 of the tapping device 100 from gripping into the tunnel 86 during insertion. .

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

FIGS. 19-23 show the threaded skin port 120 used for the sub-mentonal access site on the midline. The threaded skin port 120 is introduced at the same time as the skin ports 80 described above. However, this is not a limitation on the present invention. Port 120 includes a protruding edge 122 having a tube 124 extending therefrom. Pipe 124 is preferably threaded 126. As shown in FIG. 22, tube 124 and protruding edge 122 collaborate to define a tunnel 128 therethrough. In a preferred embodiment, the tunnel portion 128 at the protruding edge 122 includes a beveled or tapered edge 128a. In a preferred embodiment, port 120 includes a pair of cable portions 130 extending upwardly over protruding edge 122 that assist the surgeon to thread port 120 at the sub-mentary access site in the midline.

However, the cable portions 130 are not a limitation in the present invention and may be omitted. Any skin port allowing access through the skin is within the scope of the present invention. For example, skin port 80 or the like may be used at the sub-Mentonian access site on the midline. In another embodiment, port 120 may be used at access point 14. In a preferred embodiment, port 120 is unobstructed to assist in the passage of the tapping device 100. That is, when the tip 104 of the tapping device 15. 100 get close to port 120 will transilluminate.

In use, the tube 124 is introduced at the sub-mentonal midline access site. The portions of the cable 130 are grasped and the port 120 is rotated so that the 20 threads 126 are threaded into the skin until the lower surface of the protruding edge 122 rests in front of the outer surface of the skin.

In another embodiment, a port similar to skin port 80 described above, but somewhat modified may be used for midline access. In this embodiment, the protruding edge includes a threaded interior that engages the threads outside 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

3 0 turns on it, but (because it is not internally threaded) causes the ring to not mount above the pipe threads. The opposite ends of the folding elements are connected to the protruding edge.

With this configuration, when the tube is rotated 5 (preferably by coupling with the surgeon's hand or fingers), the threaded coupling from the outside of the tube to the inside of the protruding edge causes the tube to move externally ( relative to the interior of a patient's body). This action causes the 10 folding elements to fold into the fold. In use with a patient, in the bent 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 was in the unbent position.

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 the supporting matrix 200 is created, the two ends 150a and 150b of the suture are brought out through the midline sub-mentonal access site (through the port). 120) as shown in FIG. 19. A single launch node 150c is placed (it will be understood that the type of node is not a limitation in the present invention) and the node positioning instrument 140 is used to adjust the node 150c.

One end 142 of the node positioning instrument 140 (which is preferably threaded) enters the handpiece 60 and the other end 144 is bifurcated. Forked end 144 is used to push knot 150c through port tunnel 128 of threaded skin 120 and under skin. In a preferred embodiment, the node positioning instrument 140 includes a fiber optic core 152 and an aperture 152a through which light is transmitted to illuminate the work area when placing the knob.

5 node 150c.

After node 150c has been pushed through threaded port 120, threaded port 120 is twisted out of the access location and the other skin ports 80 are removed using handheld 60. To do this, male connector 10 is It is introduced into port 80 so that the ridge 68a engages the indented ring 82a and the teeth 68b and 82b engage each other. The handpiece 60 is then twisted, thereby rotating the tube 84 and causing the internally threaded ring 90b to travel back down from the 15 threads 88 and unfolding by folding the bending members 90a. In another mode, ports 80 may be removed by hand.

After atraumatic removal of ports 80 and 120, 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 holding matrix 200.

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 3 00 threading device is usually straight and accurate

To travel around the mandible curvature, requires intermittent access locations 14 under the mandible to allow the threading rod to be redirected around the neck curvature (the exemplary access location showing this is marked 14a). The surgeon may choose to use 5 other access sites under the patient's jaw or other locations as needed to allow the threading rod to be redirected.

As shown in FIG. 51, prior to using the tapping device, the surgeon may wish to use the cleaning device 10 (or cleaning device assembly 341) to clean skin attachments under the area adjacent the access sites 14. Although not shown in FIGS. 51-56, the surgeon may also use nozzle 339 or 33 9b to assist in securing threading rod 300 and to assist in manipulating handpiece 360 during surgery.

For initial entry of the threading device 300 and the first suture 150 the surgeon creates an access site 14a under the chin. The handpiece 360 is illuminated (e.g., by pulling the torn cord, twisting or pushing the tail cone or otherwise turning on the light source) and the threading device 300 is introduced into the handpiece 360. Threading device 300 is introduced through access site 14a as shown in FIG. 52. Illuminated tip 304 of tapping device 300 illuminates the work area and transilluminates through the skin allowing the surgeon to determine the proper placement of the support die 200 and the location of the tip 304.

The threading rod is then brought out 30 through a second access site 14b and a portion of the suture is pulled through the second access site 14b. Sufficient of the suture is pulled through second access site 14b so that only sufficient of the suture is still protruding out of location 14a so that the suture can be tied off at the end of the procedure (described below). To prevent the end of the suture being pulled by the first access site 14a, it may be anchored by something, such as a hemostat. It will be appreciated that by suturing it in the middle of the threaded rod 300, the surgeon does not have to pull the entire threaded rod out of the access site. Alternatively, after more than half of the threaded rod is pulled through the site and the suture is pulled through, the surgeon may rotate the rod in the desired direction 15 and then begin to push the rod back through the access site. This action allows the suture to anchor in the ligaments under the skin near the access sites. It will be understood that because the threaded rod 300 has the suture attached near its half and has two ends, it does not have to be rotated each time it is brought out from below the patient's skin. However, the surgeon may turn the threading rod around as desired.

Before pushing the threading rod back

25 for second access site 14b, the surgeon places the handpiece at the end of the threading rod to illuminate the tip 304, as shown in FIG. 53

The threading rod is then threaded from location 14b to location 14a, is rotated and is passed subcutaneously to the third access site 14c. Depending on the patient, the surgeon may thread straight from location 14b to location 14c without turning the rod 14a. This is repeated for the fourth, fifth and sixth access points 14d, 14e, and 14f and eventually the threading rod is brought out through the sub-mental access site (each time the surgeon does not always have to return). out through location 14a but can go directly to the next location in the "shoelace") · It will be understood that the handpiece is removed and placed on the threading rod as desired 10 during this procedure so that one of the tips 304 is illuminated as wished. Suture 150 is then cut from the threaded 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 thereto, thereby creating an anchor or pivot point.

As shown in FIG. 54, a second suture 151 is then tied to the threading rod 300 and the threading rod is inserted into the first access site 14a. It is then passed subcutaneously to the seventh access site 14g. Similar to the procedure described above for the first suture 150, the second suture 151 is then threaded at the eighth, ninth, eleventh and eleventh access points 14h, 14i, 14j and 14k (see FIG. 55) and is finally brought out of the subentonian access site in the midline. The ends of the sutures 150 and 151 extending out of site 14a are then tied together thereby completing the matrix 200 (see FIG. 56). Node 150c is then pushed through location 14a and under the skin 30 (for example, using the wiper or threaded rod). At this time, the surgeon may pull the ends of the sutures 150 and 151 extending out of the sub-mental access site to place the desired tension on the matrix 200. Once this is done, the 5 ends of the sutures 150 and 151 they are tied together and the knot 150c is pushed through the spot and under the skin.

It will be understood that surgery can be performed without the handheld device. Some surgeons may want to use the tapping device alone without using the handheld device to illuminate the tips. In this situation a continuous threading device or a threading device with independent power and light sources may be used. It will be better understood that threading device 300 may be used for other types of surgery. For example, it can be used to place suture systems that are commonly used in plastic surgery that previously requires the opening or lifting of the skin of the face, neck and / or other areas of the body. Examples of this include the use of this device or system for placing a neck-defining suture or may be used in the minimal access cranial suspension (MACS-Iift), which is described in The MACS-Iift Short Scar Rugasectomy by Patrick Tonnard , MD and Alexis Merpaile, MD, Aesthetic surgery Journal, volume 27, number 2, pgs. 25 188-198, March / April 2007, which is incorporated herein by reference in its entirety. In this procedure, "purse-string" sutures are used. To place the sutures, the surgeon could use the threaded rod 300 instead of making the incisions that are typically made.

The suture that defines the neck, as shown in the art, is described in the article Suture Suspension Platysmaplasty for Improving Outcomes by Vincent Giampapa, MD, Ioannis Bitzos, MD, Oscar Ramirez, MD, and Mark Granick, MD, Aesthetic Plastic Surgery , Vol. 29, pgs. 341-350, 2005.,

5 which is incorporated herein by reference in its entirety. However, instead of having to make large incisions and elevating the skin under the neck, the procedure can be performed by making a small incision behind the ears and then threading the subcutaneous suture under the jaw using the threaded rod 3. 00 and required pivot points (access locations) as desired.

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 fiber optic yarn interlaced with non-fiber optic yarns. Suture 150 is braided as is known in the art with one, two or three fiber optic threads and one or two non-fiber optic threads as desired. This assists in transillumination of suture 150 to verify subcutaneous placement after suture 150 has been placed. Fiber optic wire 150d will illuminate when handheld fiber optic light 60 coupled with knot placement instrument 140 approaches the suture as it is tied. Light transmitted to the suture allows the surgeon to visualize the placement of the support matrix 200 while it is fixed. Non-fiber optic yarns may be made of any material known in the art, such as nylon, polypropylene, or other non-absorbable material. At any point during the creation of the support matrix 200, suture placement can be confirmed by placing the handpiece 60 or 360 (or any light source) at one end 150a or 150b of the suture 150,

5 thus transmitting the light down the fiber optic wire 150d to verify suture placement 150.

Illumination of the suture path allows the surgeon to determine the suture site. In general, suture illumination gives the surgeon the answer to the anatomical movement of each pivot point.

It will be appreciated by those skilled in the art that fiber optic suture may be used in all areas of surgery or other materials where an illuminated ligation material is required, and not only in the technique described herein. In another embodiment, the threading device may be a straight or bent needle. Application of light energy during a surgical procedure will confirm the placement and accuracy of the suture. Postoperative light application could allow the 20 surgeons to understand the evolution of suture placement in relation to time and aging.

In an alternative embodiment, the neck skin may be raised from the platysma muscle through an incision similar to that used in the standard procedure discussed above 25 to allow the surgeon to visualize the operative field and then the suture matrix to be placed through ports 80. and / or access points 14.

It is contemplated that the above described instruments may be sold in kits. For example, a kit with all 30 or any combination of instruments including tape 10 or 310, a marking pen, lancet 40, handheld device 60 or 360, skin ports 80, threading device 100 or 300 threaded skin port 120, knot positioning instrument 140, suture 150 or 151, nozzle 5 339 or 339, cleaning device 321, cleaning device assembly 341 or any other instrument described herein may be sold.

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 embodiments described above without departing from the inventive concepts disclosed herein. Therefore, the present invention should be defined solely by the scope of the following claims.

Claims (72)

Surgical kit, characterized in that it comprises: a threading device, wherein the threading device comprises an elongated rod having first and second opposite ends, and wherein the diameter of the elongated rod at or near the first end is about the same as the diameter of the elongate rod at or near the second end, wherein the kit comprises the threading device and at least two of the following: at least one strip element, where the strip element includes a plurality of defined perforations through it a lancet, where the lancet includes a symmetrical puncture blade, a handheld device, and a suture. Surgical kit according to claim 1, characterized in that the hand-held device comprises: a. a generally tubular shaped main body portion having first and second opposite ends and defining a longitudinal axis, b. an instrument coupling extending from the first end of the main body portion, where the instrument coupling is generally tubular in shape and has an interior that can receive the first or second end of the threading device, and c. where the handheld device is adapted to emit light by coupling the instrument. Surgical kit according to claim 2, characterized in that the elongate rod is hollow and defines an interior, where at least: a. one end of the elongate stem includes a blind tip affixed thereto, where the blind tip is translucent, and b. a fiber optic core comprising at least one fiber optic wire extending through the interior of the elongate rod, whereby the translucent tip is illuminated when at least one fiber optic wire is energized. Surgical kit according to claim 1, characterized in that the suture is permanently attached to the threading device. Surgical kit according to claim 1, characterized in that the lancet comprises: a stopping member having an upper surface and a lower surface, a blade extending upwardly from the upper surface of the lancet. the blade including two symmetrical sharp edges, each having first and second ends, and two blind edges, each having first and second ends, where the first edges of the sharp edges meet at one point and extend from the point at an angle of approximately 90 ° or less, where the first ends of the two blind edges extend downward from the second ends of the two sharp edges, where the angle formed between the sharp edges and the corresponding blind edges is obtuse, where the second ends of the two blind edges are connected to the stop element, where the two edges of the blinds form approximately a right angle to the upper surface of the stopping member, and where the two blind edges extend approximately parallel to each other from where they extend downward from the sharp edges to the point where they meet the stopping member. , and a hand-held device extending below the lower surface of the stopping element. Surgical kit according to claim 1, characterized in that the perforations in the tape element are sized so that the lancet punching blade can pass through them, and where the lancet is sized and adapted to create a punch that the threading device can pass through. Surgical kit according to claim 1, characterized in that the kit includes the threading device, at least one element of the tape, the lancet, the handpiece and the suture. Surgical kit according to claim 3, characterized in that the kit includes the threading device, at least one element of the tape, the lancet, the handpiece and the suture. Surgical kit according to claim 1, characterized in that the perforations in the at least one element of the tape are spaced equidistant from each other. Method according to claim 9, characterized in that the perforations in the at least one element of the tape are positioned along the longitudinal center of the tape. 11. Method of marking the skin before surgery, characterized by the fact that it comprises the steps of: a. providing first and second ribbon elements each having a plurality of defined perforations therethrough, b. placing the first element of the tape on a portion of the skin, c. placing the second ribbon element on a portion of the skin where the first ribbon element is spaced from the second ribbon element, d. marking the skin through at least one of the perforations in the first element of the tape, e.g. marking the skin through at least one of the perforations in the second element of the tape, and f. removing the first and second elements of the skin tape. Method according to claim 11, characterized in that the perforations in the first and second elements of the tape are spaced equidistant from each other. Method according to claim 12, characterized in that the perforations in the first and second ribbon elements are positioned along the longitudinal center of the ribbon. Method according to claim 11, characterized in that the first and second ribbon elements are made of a clear material. 15.of missing claim Method according to claim 12, characterized in that the markings made with the first ribbon element are symmetrical with the markings made with the second ribbon element. 17. Article of manufacture, characterized in that it comprises: a. a stop member having an upper surface and a lower surface, b. a blade extending above the upper surface of the stopping member, the blade including two sharp edges each having first and second ends and two blind edges each having first and second ends, where the first edges of the sharp edges meet at each other. a point and extend from the point at an angle of approximately 90 ° or less, where the first ends of the two blind edges extend below the second ends of the two sharp edges, where the angle formed between the sharp edges and the edges corresponding blind is obtuse, where the second ends of the two blind edges are connected to the stopping element, where the two blind edges form approximately a right angle with the upper surface of the stopping element, and where the two blind edges extend approximately parallel one another from the point where they extend below the sharp edges while where they meet the stopping element, and c. a cable extending downwardly from the bottom surface of the stop member. An article of manufacture according to claim 16, characterized in that a first width is defined between the points where the first ends of the two blind edges meet the second ends of the two sharp edges, and where the blade is adapted to create a punch that is no wider than the first width. 19. Skin piercing device, characterized in that it comprises: a. a stop member having an upper surface and a lower surface, b. a generally smooth blade extending above the upper surface of the stopping member, the blade including two sharp edges each having first and second ends and two blind edges each having first and second ends, where the first edges of the sharp edges meet. meet at one point and extend from the point at an angle of 90 ° or less, where the first ends of the two blind edges extend below the second ends of the two sharp edges, where the angle formed between the sharp edges and the corresponding blind edges are obtuse, and where the second ends of the two blind edges are attached to the stopping element, where the two blind edges form approximately a right angle with the upper surface of the stopping element, where the two blind edges extend approximately parallel to one another along its entire length, and where a first width is defined between the two blind edges, and where the blade is adapted to create a punch that is not wider than the first width, and c. a cable extending below the lower surface of the stop member. Skin piercing device according to claim 18, characterized in that the blade includes only two sharp edges. Skin piercing device according to claim 18, characterized in that the stopping element is disc-shaped. 22. Suturing threading device means a device characterized in that it comprises: a. an elongate tube having first and second opposite ends, an interior and a suture attachment site, wherein at least one of the first and second ends of the elongate tube includes a blunt end, where the blind end is translucent, and b. a fiber optic core comprising at least one fiber optic wire extending through the interior of the elongate tube, whereby the translucent tip is illuminated when at least one fiber optic wire is energized. Threading device according to claim 21, characterized in that the suture attachment site is defined approximately at the longitudinal center of the elongated tube. Threading device according to claim 21, characterized in that it further comprises a suture permanently attached to the suture attachment site. Threading device according to claim 33, characterized in that it further comprises a suture permanently attached to the suture attachment site. 26. Suturing threading device means a device characterized in that it comprises: a. an elongate tube having first and second opposite ends and an interior, wherein at least one of the first and second ends of the elongate tube includes a blind tip, where the blind tip is translucent, where the elongate tube is malleable, b. a fiber optic core comprising at least one fiber optic wire extending through the interior of the elongate tube, whereby the translucent tip is illuminated when the at least one fiber optic wire is energized, and c. a suture permanently attached to the elongate tube approximately at the longitudinal center thereof. 27. Method of creating a suture support matrix under the skin of a person, the method comprising the steps of a. providing a suture having first and second opposite ends, where the suture has a first threading device connected to the first end and a second threading device connected to the second end, where the first and second threading devices each include a portion. length of the main body having first and second opposite ends, b. introducing the first tapping device through a first opening into the skin, c. pulling at least a portion of the first threading device through a second opening in the skin, d. reintroducing the first threading device through the second opening in the skin, e.g. pulling the first threading device through a third opening in the skin, f. disconnecting the first threading device from the first end of the suture, g. introducing the second threading device through the first opening in the skin, h. pulling at least a portion of the second threading device through a fourth opening in the skin, i. reintroducing the second threading device through the fourth opening in the skin, j. pulling the second threading device through the third opening in the skin, k. disconnecting the second threading device from the second end of the suture, and l. tying the first and second ends of the suture into a knot. Method according to claim 27, characterized in that the user performing the method connects the first and second suture ends to the first and second threading devices, respectively. Method according to claim 27, characterized in that the first and second suture ends are permanently connected to the first and second threading devices, respectively. A method according to claim 27, characterized in that the first and second threading devices each include at least one illuminated tip. Method according to claim 30, characterized in that the first and second threading devices each include a fiber optic core. Method according to claim 27, characterized in that the first threading device is connected to a handheld device before being introduced through the first opening in the skin, and where the first threading device is disconnected from the device. after at least a portion of the first threading device has been pulled through the second opening in the skin. 33. A method of creating a suture support matrix under a person's skin, the method comprising the steps of a. connecting a threading device to the first end of a suture, where the threading device includes an elongated portion of the main body having opposite first and second ends, b. introducing the threading device through a first opening into the skin, c. pulling at least a portion of the threading device through a second opening in the skin, d. reintroducing the threading device through the second opening in the skin, e.g. pulling the threading device through a third opening in the skin, f. disconnecting the threading device from the first end of the suture, g. connecting a threading device to the second end of the suture, h. introducing the threading device through the first opening in the skin, i. pulling the threading device through a fourth opening in the skin, j. reintroducing the threading device through the fourth opening in the skin, k. pulling the threading device through the third opening in the skin, l. disconnecting the threading device from the second end of the suture, and m. tying the first and second ends of the suture into a knot. Method according to claim 33, characterized in that the threading device connected to the first and second ends of the suture is the same threading device. Method according to Claim 33, characterized in that the threading device connected to the first end of the suture is different from the threading device connected to the second end of the suture. 36. Method for threading a suture into a patient's body characterized by the fact that it comprises the steps of: a. providing a suture, b. providing a threading device comprising an elongate stem having a local tie-off suture and first and second ends, c. tying the suture to the local tie-off suture, d. introducing the first end of the elongated stem through a first opening into the patient's skin, e.g. passing the first end of the elongated rod subcutaneously to a second opening in the patient's skin, f. pulling the first end of the elongate stem and a portion of the suture through the second opening, g. without turning the elongate rod around, passing the second end of the elongate rod subcutaneously to an opening in the patient's skin, where at least at one point during the performance of the method the first end of the elongate rod extends outside the first opening and the second end of the elongate rod extends through the second opening. A method according to claim 36, characterized in that the local tie-off suture comprises a defined groove in the stem extending substantially circumferentially around the stem. Method according to Claim 36, characterized in that the local tie-off suture comprises an eyelet extending through the shank. A method according to claim 36, characterized in that the local tie-off suture is disposed at a location distant from the first and second ends. A method according to claim 36, characterized in that the local tie-off suture is disposed at a location that is approximately midway between the first and second ends. A method according to claim 36, further comprising the step of illuminating the first end of the elongate rod prior to step (e). Method according to Claim 36, characterized in that the threading device has first and second ends which are each illuminated at predetermined points during the method. 43. Method of performing surgery, the method characterized by the fact that it comprises the steps of: a. placing a ribbon mold on a portion of a patient's skin, b. marking a plurality of access places, c. making an opening to form a midline access location, d. performing liposuction, e.g. forming a plurality of openings in the skin at the access points, f. providing a threading device having a suture attached thereto, and i. introducing the threading device and the suture through a plurality of access points to form a suture matrix under the skin. A method according to claim 43, characterized in that the threading device has first and second ends which are each illuminated at predetermined points during surgery. Method according to claim 43, characterized in that the threading device where the suture is attached to the threading device at a point which is approximately midway between its ends. 46. Surgical kit characterized in that it comprises at least two of the following: a. at least one ribbon element, b. a lancet, c. a handheld device, d. a cleaning device, e.g. a threading device, and f. a suture. Surgical kit according to claim 46, characterized in that the hand-held device comprises: a. a tubular member having first and second opposite ends and defining a longitudinal axis, b. an instrument coupling extending from the first end of the tubular member including an opening for receiving a rod, and c. a light source, where light from the light source is directed out of the opening in the instrument coupling. Surgical kit according to claim 46, characterized in that the threading device comprises an elongated stem having a defined groove therein extending at least substantially circumferentially around the stem, wherein the elongated stem has first and second opposite ends, and where the ends are blind. Surgical kit according to claim 46, characterized in that the threading device comprises: an elongated tube having first and second open ends and a local tie-off suture disposed approximately in the middle between the first and the second one. ends, a light guide running through the elongate tube, where the light guide has first and second ends and where the first and second ends of the light guide are substantially aligned with the first and second ends of the tube. Surgical kit according to claim 46, characterized in that the cleaning device comprises a neck defining a longitudinal axis and a cleaning portion extending from the neck, wherein the cleaning portion extends in one direction. curved path that defines a plane that is approximately perpendicular to the longitudinal axis of the neck. 51. Article of manufacture characterized in that it comprises: a. a tubular member having first and second opposite ends and defining a longitudinal axis, b. an instrument coupling extending from the first end of the tubular member including an opening for receiving a rod, and c. a light source, where light from the light source is directed out of the opening in the instrument coupling. Article of manufacture according to claim 51, characterized in that it further comprises a power source disposed within the main body portion, and where the light source and the power source are part of an electrical circuit. An article of manufacture according to claim 51, characterized in that the opening in the coupling of the instrument is polygonal to prevent a rod arranged therein from rotating. An article of manufacture according to claim 51, characterized in that the light source is an LED positioned adjacent the opening in the instrument coupling. An article of manufacture according to claim 51, further comprising a threaded rod received at the opening in the instrument. An article of manufacture according to claim 55, characterized in that the threaded rod comprises a tubular member, a tie-off suture and a light guide extending through the tubular member. 57. Method characterized by the fact that it comprises the steps of: a. providing an instrument comprising i. a generally tubular member having first and second opposite ends, ii. an instrument coupling extending from the first end of the tubular member, where the instrument coupling includes an opening for receiving a rod, and iii. a light source, where light from the light source is directed out of the opening in the instrument coupling, b. providing a threaded rod having first and second opposite ends, c. inserting the first end of the threaded rod into the opening in the instrument coupling, and d. directing light from the light source through the threading rod and out of the second end of the threading rod. A method according to claim 57, characterized in that the threaded rod comprises: i. a tubular member having first and second ends, and ii. a light guide extending through the tubular member, where light is directed at one of the first and second ends, through the light guide and outward at the other of the first and second ends. A method according to claim 58, characterized in that the threaded rod comprises a local tie-off suture. A method according to claim 59, characterized in that the local tie-off suture comprises a groove extending at least substantially circumferentially about the outside of the tubular member. 61. The method of claim 58, wherein the light source is a high efficiency LED that emits light at a narrow focus angle, and where the numerical aperture of the light guide is approximately matched by light. emitted from the LED. 62. Threading device, characterized in that it comprises an elongate rod having a defined groove therein extending at least substantially circumferentially around the rod, where the elongate rod has first and second opposite ends, and where the ends are blind. , a received suture not tied around the groove. Threading device according to claim 62, characterized in that the groove is arranged at a location distant from the first and second ends. Threading device according to claim 63, characterized in that the groove is arranged in a location that is approximately halfway between the first and second ends. Threading device according to claim 62, characterized in that the ends of the rod are bent. 66. Threading device comprising: an elongated tube having first and second open ends and a local tie-off suture disposed approximately halfway between the first and second ends, a light guide operating through the tube. elongated, where the light guide has first and second ends and where the first and second ends of the light guide are substantially aligned with the first and second ends of the tube, and a received suture is not tied around the local tie-off suture. Threading device according to Claim 66, characterized in that the local tie-off suture comprises a groove extending at least substantially circumferentially around the outside of the tube. 68. A cleaning device characterized in that it comprises a neck defining a longitudinal axis and a cleaning portion extending from the neck, wherein the cleaning portion extends in a curved path defining a plane which is approximately perpendicular to the axis. neck lengthwise. 69. A method characterized by the fact that it comprises the steps of: a. providing a handheld device comprising i. a generally tubular member having first and second opposite ends, ii. an instrument coupling located at the first end of the tubular member, where the instrument coupling includes an opening for receiving a rod, and iii. a light source, where light from the light source is directed outside the aperture in the instrument, b. providing a cleaning device including a coupling portion and a cleaning portion having a tip, and c. by coupling the cleaning device coupling portion with the instrument coupling. Method according to claim 69, characterized in that the neck defines a longitudinal axis and the cleaning portion extends in a curved path defining a plane which is approximately perpendicular to the longitudinal axis of the neck. A method according to claim 69, characterized in that it comprises the step of introducing the cleaning portion into a puncture in a patient's skin and sweeping the cleaning portion over the puncture to clean any objects in the surrounding area. of the puncture. Method according to claim 69, characterized in that the coupling portion of the cleaning device includes the internal threads which are received threaded at the coupling of the instrument and a portion of the neck that is received at the opening in the coupling of the cleaner. instrument.