Patent Application
20230126300
The invention relates generally to thread for surgical applications. More particularly, the invention relates to six-dimensional barbed surgical thread.
A variety of aesthetic medical techniques have been developed to enhance the appearance of a person's skin and, in particular, the appearance of the person's face. These techniques range from cutting and tightening of the skin to injecting compositions into the skin such as to reduce wrinkles. Despite these advances, there is a continuing need for non-surgical techniques to improve a person's appearance.
An embodiment of the invention is directed to a six-dimensional barbed surgical thread that includes a central core and six first barbs. The central core has a circumference, a proximal end and a distal end that is opposite the proximal end. The six first barbs are positioned around the circumference of the central core so that the first barbs are radially adjacent to each other and obliquely extend from the central core.
Another embodiment of the invention is directed to a six-dimensional barbed surgical thread a central core, six first barbs and six second barbs. The central core has a circumference, a proximal end and a distal end that is opposite the proximal end. The six first barbs are positioned around the circumference of the central core and obliquely extend from the central core. Each of the six first barbs has a distal end and a proximal end. The distal end of one of the first barbs is closer to the proximal end of the central core than the proximal end of the one of the second barbs. The six second barbs are positioned around the circumference of the central core and obliquely extend from the central core. The six second barbs are closer to the proximal end than the six first barbs. Each of the six second barbs has a distal end and a proximal end. The distal end of one of the second barbs is closer to the distal end of the central core than the proximal end of the one of the second barbs.
Another embodiment of the invention is directed to a method of using a six-dimensional barbed surgical thread. A six-dimensional barbed surgical thread is provided that includes a central core, six first barbs and six second barbs. The central core has a circumference, a proximal end and a distal end that is opposite the proximal end. The six first barbs are positioned around the circumference of the central core and obliquely extend from the central core. Each of the six first barbs has a distal end and a proximal end. The distal end of one of the first barbs is closer to the proximal end of the central core than the proximal end of the one of the second barbs. The six second barbs are positioned around the circumference of the central core and obliquely extend from the central core. The six second barbs are closer to the proximal end than the six first barbs. Each of the six second barbs has a distal end and a proximal end. The distal end of one of the second barbs is closer to the distal end of the central core than the proximal end of the one of the second barbs. The six-dimensional barbed surgical thread is inserted into a dermis on a patient. The six first barbs engage the dermis to lift the dermis to a lifted position. The six second barbs engage the dermis to anchor the dermis in the lifted position.
The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
The invention is directed to a six-dimensional barbed surgical thread as illustrated at 10 in
An advantage of the six-dimensional barbed surgical thread 10 over the prior art barbed surgical threads is that the six-dimensional barbed surgical thread 10 of this invention produces multiple effects once introduced into the dermis.
These effects fall into three major categories: (1) instant skin lifting through mechanical effects, (2) cellular renewal through collagen stimulation and neovascularization to improve skin texture, fine lines and elasticity, and (3) skin tightening by contracting fat tissue.
The six-dimensional barbed surgical thread 10 is a medical device that in certain embodiments consists of a monofilament surgical suture. The six-dimensional barbed surgical thread 10 may be fabricated from a variety of materials. In certain embodiments, the materials used to fabricate the six-dimensional barbed surgical thread are absorbable inside of a human body. A non-limiting example of a suitable material for fabricating the six-dimensional barbed surgical thread 10 is a polydioxanone (PDO)/polycaprolactone (PCL) polymer.
In certain embodiments, a cut is used to form each of the barbs 22. A variety of cutting techniques may be used. In certain embodiments, the six-dimensional barbed surgical thread 10 is fabricated by laser cutting into the surgical suture hexagonally at an angle of about 60 degree as illustrated in
Using such a configuration, the six first barbs 22 are radially adjacent to each other when going around a circumference of the six-dimensional barbed surgical thread 10. While in certain embodiments, the first barbs 22 are immediately radially adjacent to each other, it is possible that there can be a spacing between adjacent first barbs 22. As used herein, the spacing between adjacent first barbs 22 is less than about 20 percent of the width of the widest portion of the first barbs 22. In other embodiments, the spacing between adjacent first barbs 22 is less than about 10 percent of the width of the widest portion of the first barbs 22.
Using the preceding configuration enhances the potential of contacts between the first barbs 22 after insertion into the dermis regardless of the orientation of the six-dimensional barbed surgical thread 10, which reduces the potential of the dermis sagging after insertion of the six-dimensional barbed surgical thread 10.
The cutting that is done to form the first barb 22 is done at an angle to the surface of the central core 20. In certain configurations, the first barbs 22 are oblique, notched protrusions formed into a surgical suture at an angle of between about 10 degrees and about 15 degrees. In other embodiments, the angle of the cut to form the first barb 22 is about 12.5 degrees. Cutting in this manner causes a width of the first barb 22 decreases when moving from the proximal end 40a to the distal end 42a. In certain embodiments, the distal end 42a of the first barb 22 is pointed.
In certain embodiments, a ratio of a length of the barb to a width of the barb is between about 2:1 and about 5:1. Forming the first barbs 22 with the length to width ratio in this range provides the first barbs 22 with sufficient strength for the first barbs 22 to perform the desired functions during the insertion process and after insertion.
Adjacent first barbs 22 may be offset in a direction moving from a distal end 32 to a proximal end 30 of the central core 20 as illustrated in
The first barbs 22 have the proximal end 40a and the distal end 42a. The proximal end 40a is where the first barb 22 attaches to the central core 20. The distal end 42a is opposite the proximal end 40a.
The plurality of first barbs 22 are cut at intervals of about 60 degrees on six sides of the six-dimensional barbed surgical thread 10. In certain embodiments, the distance between adjacent first barbs 22 is about 1.5 millimeters, which is closer than the conventional spacing of about 1.8 millimeters that is used in the prior art surgical thread that is used when performing facelifts.
The plurality of first barbs 22 are oriented such that the distal end 42a of each first barb 22 is closer to the central core distal end 32 than the proximal end 40a of each first barb 22. As described in more detail below, a primary function of the plurality of first barbs 22 is lifting.
In certain embodiments, the plurality of first barbs 22 occupy greater than about ½ of a length of the six-dimensional barbed surgical thread 10. In other embodiments, the plurality of first barbs 22 occupy about ⅔ of the length of the six-dimensional barbed surgical thread 10.
The six-dimensional barbed surgical thread 10 is typically inserted so that the plurality of first barbs 22 are facing upwardly. The configuration of the plurality of first barbs 22 on the six-dimensional barbed surgical thread 10 thereby allows for most of the six-dimensional barbed surgical thread 10 to assist in lifting of the tissue.
The six-dimensional barbed surgical thread 10 also includes a plurality of second barbs 24 proximate the central core proximal end 30. The six-dimensional barbed surgical thread 10 is typically inserted so that the plurality of second barbs 24 are facing downwards. As described in more detail below, a primary function of the plurality of second barbs 24 is anchoring.
The plurality of second barbs 24 are cut at intervals of about 60 degrees on six sides of the six-dimensional barbed surgical thread 10. In certain embodiments, the distance between adjacent second barbs 24 is about 1.5 millimeters, which is closer than the conventional spacing of about 1.8 millimeters that is used in the prior art surgical thread that is used when performing facelifts.
Other than the orientation, the second barbs 24 may be shaped similarly to the first barbs 22. The plurality of second barbs 24 are oriented such that the distal end 42b of each second barb 24 is closer to the central core proximal end 30 than the proximal end 40b of each barb 24.
In certain embodiments, the plurality of second barbs 24 occupies less than about ½ of the length of the six-dimensional barbed surgical thread 10. In other embodiments, the plurality of second barbs 24 occupies about ⅓ of the length of the six-dimensional barbed surgical thread 10.
In certain embodiments, there may be an intermediate region 34 of the six-dimensional barbed surgical thread 10 that is intermediate the upwardly facing first barbs 22 and the downwardly facing second barbs 24 from which no barbs extend therefrom. This intermediate region 34 on the six-dimensional barbed surgical thread 10 may have a length that is smaller than the length of the six-dimensional barbed surgical thread 10 over which the upwardly extending first barbs 22 extend. The length of the intermediate region of the six-dimensional barbed surgical thread 10 may be smaller than the length of the six-dimensional barbed surgical thread 10 over which the downwardly extending second barbs 24 extend.
Unlike the prior art two-dimensional, three-dimensional and four-dimensional barbed surgical thread that limited the ability to engage tissue, the six-dimensional barbed surgical thread 10 of this invention significantly improves the viability and uniformity of tissue engagement thus the sustainability of the desired result.
Additionally, upon insertion of the six-dimensional barbed surgical thread 10 into the dermis, the dermis sustains minor injuries. These minor injuries engages the body's natural healing process and stimulate the skin cells to produce collagen and blood vessels, which improves skin microcirculation.
It has been found that in areas of the body that do not have bone structure beneath, such as the fatty area of the cheek, having more points of tissue attachment provides a greater degree of lift, greater points of injury and a larger amount of fiberblasting, which thereby results in greater collagen production.
The six-dimensional barbed surgical 10 is inserted into the subcutaneous layer of the dermis. In certain embodiments, a cannula is used to insert the six-dimensional barbed surgical thread 10 into the dermis. In other embodiments, the cannula is a rounded or L-tipped surgical steel cannula.
The six-dimensional barbed surgical thread 10 is not attached to the surgical cannula and is introduced into the soft tissue through the tip of the cannula. Once the cannula reaches the desired end site, the cannula is rotated about 180 degrees mechanically engaging the six-dimensional barbed surgical thread 10 at the distal (lower) end.
The cannula is then removed leaving only the six-dimensional barbed surgical thread 10 in the dermis. Approximating the tissue up the six-dimensional barbed surgical thread 10 (lifting the tissue onto each barb) allows for each of the first barbs 22 to become securely engaged in the dermis. Once the desired result is achieved, the six-dimensional barbed surgical thread 10 is anchored at the proximal (upper) end. Any excess portion of the six-dimensional barbed surgical thread 10 is cut off and discarded.
The use of six-dimensional barbed surgical threads 10 is indicated for soft tissue augmentation where the insertion of surgical sutures is appropriate. The six-dimensional barbed surgical threads 10 are used to lift, contour and volumize the skin. The implantation of the six-dimensional barbed surgical threads 10 is indicated for subcutaneous (intradermal and hypodermal) implantation.
In operation, once the area to be treated is defined, and an appropriate examination is completed, the patient is seated. The treatment area should be prepped by cleansing and removing the topical anesthetic. If topical anesthetic is to be used, it is applied liberally to the treatment areas.
The appropriate thread packages required for the treatment area are opened and removed from the package. The thread is attached in accordance with the manufacturer's instructions. Proper use of the product should minimize the chances of dislodging or breaking while injecting the thread.
Correct injection technique is important to the success of the treatment in achieving the desired results. The needle or cannula should be inserted into the treatment site with the tip ending up at an appropriate depth within the skin. The six-dimensional barbed surgical thread 10 should then be released using a slow, steady withdrawal of the needle/cannula. Overcorrection, which is more threads than suggested or required, is generally not needed and is to be avoided.
Once the first thread is appropriately inserted, another thread is inserted into the next adjacent location, and the process is repeated. Care should be taken to adequately assess the entire area to be treated with the correct number of threads to ensure even and symmetrical distribution of the product.
Once the injection is completed, the treated areas should be gently massaged, setting the threads per instruction. More vigorous massage may result in additional swelling, bruising or dislodgement of the thread.
Unlike the prior art two-dimensional, three-dimensional and four-dimensional barbed surgical threads that are limited in their ability to engage tissue due to barbs being cut respectively on only 2, 3 or 4 sides of the thread. This greatly limits the number of points of engagement into soft tissue. It is this engagement that is necessary to achieve a sustainable lift.
With six-dimensional barbed surgical threads 10, the presence of additional first barbs 22 more than double the points of tissue engagement of the four-dimensional barbed surgical thread. Regardless of how the six-dimensional barbed surgical thread 10 is inserted into subcutaneous tissue, the additional first barbs 22 allows the six-dimensional barbed surgical thread 10 to grab onto additional dermis resulting in a better lift.
The six-dimensional barbed surgical thread that is fabricated from PDO alone or in combination with PCL is slowly absorbed after implantation into the patient. In certain embodiments, the six-dimensional barbed surgical thread is resorbed over a time period of between about 180 days and about 240 days. After this time period, the six-dimensional barbed surgical thread 10 is substantially absorbed into the surrounding tissue. As used herein, substantially absorbed means that there are only minimal traces remaining of the six-dimensional barbed surgical thread 10.
In the following example, the performance of the six-dimensional barbed surgical thread according to this invention is compared to the performance of a prior art four-dimensional barbed surgical thread.
The subject on which the procedure was performed is a 50-year-old Caucasian woman with mild asymmetry, laxity due to aging and mild to moderate scaring due to adolescent acne.
The subject complained of heavy jowls, double chin, submental droop, marionette lines, frown, heavy nasolabial folds, under eye bags, hooding of upper lids, droop in outer eyes, ptosis of eyebrows, hollowed temples and fallen cheeks creating deep malar creases. The concerns of the female subject are similar to the concerns of many 40 to 70 year old women.
On the left side of the subject's face 100 illustrated in
On the right side of the subject's face 100 in illustrated in
The lengths and gauges of the surgical threads were substantially identical on both sides of the subject's face 100 such that the only notable difference between the surgical threads used on the left and right sides of the subject's face 100 is the six-dimensional configuration that was used on the left side and the 4-dimensional configuration that are used on the right side.
The first area of interest 110, which are depicted in
The surgical threads were placed to lift and create a beautiful brow arch and wing elevation. The six-dimensional barbed surgical thread enabled a more aggressive lift due to the increased engagement points, which resulted in a visual lack of eye hooding and smoother lower eyelids as indicated by arrows 124, 126 on the left and rights sides of the subject's face 100. The six-dimensional barbed surgical thread also enabled the creation of an appearance of larger brighter left eye as compared to the fight eye.
The second and third areas of interest, which are depicted in
Notable improvements associated with the six-dimensional barbed surgical thread include elevation of eye to a more youthful position, more even distribution of lid tissue, elevation of the outer and mid brow, volume at the temple, zygomatic crest, lifting of the commissure, j owls, nasolabial smile lines (NLF) and accentuated jawline, necklines and chin.
The fourth area of interest, which is depicted in
Arrows 144 and 146 are directed to the subject's jawline, marionette line and oral commissure. The six-dimensional barbed surgical thread provided a visual facial thinning, a very defined lift and volumization of the midface, along with a lack of malar crease and minimization of the nasolabial fold.
Cosmetic medical procedures were conducted to evaluate the performance of the six-dimensional barbed surgical thread of this application to the prior art four-dimensional barbed surgical thread as well as to an eight-dimensional barbed surgical thread that is the subject of a separate patent application that is being filed on the same day as this patent application.
The performance of the respective surgical threads as evaluated with respect to lifting of the dermis and stimulating collagen production. The relative performance of the six-dimensional barbed surgical thread and the eight-dimensional barbed surgical thread with respect to the prior art four-dimensional barbed surgical thread was classified as either no change, minimal change, moderate change and significant change from the perspective of an experienced medical practitioner in the field of cosmetic medical procedures.
The results from the use of the six-dimensional barbed surgical thread, the eight-dimensional barbed surgical thread and the prior art four-dimensional barbed surgical thread in conjunction with fifteen different cosmetic medical procedures are classified as:
In view of the fact that the six-dimensional barbed surgical thread and the eight-dimensional barbed surgical thread do not exhibit superior results to the prior art four-dimensional barbed surgical thread for all of the cosmetic medical procedures set forth in Tables 1-4 and in view of the fact that the six-dimensional barbed surgical thread and the eight-dimensional barbed surgical thread exhibit similar performance in certain cosmetic medical procedures but the six-dimensional barbed surgical thread provides superior results in some cosmetic medical procedures and inferior results in some cosmetic medical procedures as compared to the eight-dimensional barbed surgical thread indicate that the six-dimensional barbed surgical thread is a not obvious modification of the prior art four-dimensional barbed surgical thread as well as the eight-dimensional barbed surgical thread.
In the preceding detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The preceding detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
It is contemplated that features disclosed in this application, as well as those described in the above applications incorporated by reference, can be mixed and matched to suit particular circumstances. Various other modifications and changes will be apparent to those of ordinary skill.
This application is a divisional of U.S. application Ser. No. 17/017,497, filed Sep. 10, 2020, and claims priority to U.S. Applic. No. 62/901,596, which was filed on Sep. 17, 2019. The contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62901596 | Sep 2019 | US | |
| 62898174 | Sep 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17017497 | Sep 2020 | US |
| Child | 18082387 | US |
