U.S. patent application number 17/724611 was filed with the patent office on 2022-09-08 for surgical tools and methods for their use.
The applicant listed for this patent is Roger K. Khouri. Invention is credited to Roger K. Khouri.
Application Number | 20220280282 17/724611 |
Document ID | / |
Family ID | 1000006351942 |
Filed Date | 2022-09-08 |
United States Patent
Application |
20220280282 |
Kind Code |
A1 |
Khouri; Roger K. |
September 8, 2022 |
SURGICAL TOOLS AND METHODS FOR THEIR USE
Abstract
Surgical tools and kits for performing methods include a grommet
with cylindrical shaft, cutting tip, annular flange with suture
retaining anchoring fixture; a grommet jig for extending between
adjacent grommets and guiding a needle therebetween; a family of
needles with single and double pointed ends, reinforced eyelets,
stops to limit inadvertent exiting, double shaft construction with
a longitudinal gap and sharpened, slicing ends, including a "J"
shape embodiment; a bone anchor with ring to secure sutures about a
patient's clavicle; a tissue dissector having radially extending
cones to nick taut connecting tissues; a tissue rasp having a
series of crisscrossing grooves along an end; a tissue mesher
comprising one or more blocks having a matrix of holes for clamping
a plurality of needles and a supporting framework; and a kit device
and a method of surgically inserting an internal mesh brassiere
under the breast skin.
Inventors: |
Khouri; Roger K.; (Key
Biscayne, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Khouri; Roger K. |
Key Biscayne |
FL |
US |
|
|
Family ID: |
1000006351942 |
Appl. No.: |
17/724611 |
Filed: |
April 20, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13884431 |
May 9, 2013 |
11318009 |
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PCT/US13/39675 |
May 6, 2013 |
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17724611 |
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61849959 |
Feb 5, 2013 |
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61643023 |
May 4, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/0608 20130101;
A61B 2017/044 20130101; A61B 90/02 20160201; A61B 2017/00792
20130101; A61B 2017/00796 20130101; A61B 17/3417 20130101; A61B
17/3494 20130101; A61B 2017/06071 20130101; A61B 2017/0414
20130101; A61B 2017/3454 20130101; A61B 2017/06042 20130101; A61B
17/205 20130101; A61B 17/0401 20130101; A61B 2017/0023 20130101;
A61B 17/06066 20130101; A61B 2017/06047 20130101; A61B 17/32053
20130101; A61B 2017/3225 20130101; A61F 13/14 20130101; A61K 35/16
20130101; A61F 2250/0067 20130101; A61B 17/0482 20130101; A61F 2/12
20130101; A61B 2017/0609 20130101 |
International
Class: |
A61F 2/12 20060101
A61F002/12; A61B 17/04 20060101 A61B017/04; A61B 17/06 20060101
A61B017/06; A61B 17/20 20060101 A61B017/20; A61B 17/34 20060101
A61B017/34; A61K 35/16 20060101 A61K035/16; A61B 17/3205 20060101
A61B017/3205 |
Claims
1. A kit for surgical use in performing a breast reconstruction,
said kit comprising a temporary bra for application to a patient's
breast intended for reconstruction, said bra being pliable for
adjusting its shape to closely conform to the patient's breast and
having a pattern of markings thereon, at least some of said
markings identifying locations for the surgeon to thread sutures
thereat which exit the patient's breast, and at least one
mechanical device to maintain an opening at one of said pattern
markings, said mechanical device having an anchor for securing a
suture which exits the bra at said mechanical device.
2-39. (canceled)
Description
BACKGROUND AND SUMMARY OF THE INVENTION
[0001] The inventor has conceived of, reduced to practice, and
patented, many inventions related to the augmentation of soft
tissue including especially the augmentation and reconstruction of
the female breast. Several examples of his patented inventions
include the following: U.S. Pat. Nos. 5,536,233; 5,662,583;
5,676,634; 5,695,445; 5,701,917; 6,083,912; 6,478,656; 6,500,112;
6,641,527; 6,699,176; and most recently U.S. Pat. No. 8,066,691,
along with other patent applications under prosecution such as
20080167613, 20100137841, and 20100160900, the disclosures of all
the foregoing being incorporated herein by reference. As his
investigative work has continued, he has continued to invent tools
and methods for their use which enable him to implement new
surgical procedures which provide strikingly improved results for
his patients over existing practices and procedures implemented by
other surgeons in this field. Many of these may be implemented
together and thus provide the basis for them to be provided in a
kit, either single use or for repeated use with one or more
patients. Similarly, several of these may be implemented not only
together but also in conjunction with the tools and methods of his
earlier work as exemplified in his patent filings mentioned above.
Furthermore, several of inventions disclosed herein, while
implemented by the inventor and having been found to work, have
alternate constructions or embodiments that the inventor has
conceived of and which are contemplated to also work and may even
be more desirable for commercialization. These tools and appliances
may be briefly summarized as follows.
[0002] A number of the inventions described, infra, are useful in a
particular breast augmentation/reconstruction procedure or a
procedure for the correction of breast deformities, whether
acquired or congenital, which will be described in greater detail
below as part of the Detailed Description of the Preferred
Embodiments and illustrated in the drawings included herein. The
inventor has coined the term Reverse Abdominoplasty and
Lipo-Filling (RAFT) to describe this procedure which is a minimally
invasive alternative method of breast reconstruction that utilizes
the anterior abdominal apron as a reverse abdominoplasty flap. The
RAFT procedure was initially developed as a means of salvaging the
failed implant augmentation and reconstruction procedures and the
inventor later realized that it was also a very useful means of
augmenting the small breast, of correcting the breast deformities,
or treating scars or chest wall wound defects, and of
reconstructing mastectomy defects. Essentially, it comprises a
purse string suture that can be threaded through the
dermis/subdermal tissue layers of the abdominal skin apron that is
to be advanced and incorporated into the breast, and a mechanism to
suspended this suture to the clavicle to secure the advancement,
and to tighten it in order to induce a mushrooming out projection
of the breast and to sculpt a pleasing inframammary and lateral
breast folds. The abdominal apron to be advanced is usually first
filled with a tumescent fluid and liposuctioned to loosen it and
deflate it. This is followed by extensive percutaneous dissection
to create an interface to ensure long term maintenance of the
suspension and the repositioned tissue independent of the suture.
The advanced abdominal and lateral thoracic flaps by themselves add
significant volume to the breast mound. Lipofilling the breast and
the purse-stringed advanced flaps adds more volume and shape to
created breast mound. Percutaneously meshing the deeper retaining
structures that restrict the advancement of the abdominal apron
expands it (similar to a skin graft mesh expansion pattern) and
alleviates the tension. It also serves to divide the cutaneous
perforator nerves that would normally cause pain if they are
stretched but usually not if they are simply divided. As shown in
FIG. 41, use of the tissue mesher allows for further advancement of
the abdominal skin apron. The reconstruction is with local
breast-like tissue, is incisionless, minimally invasive and patient
friendly. It is considered by the inventor as a first choice
reconstructive option that is also available when all else has
failed or in some cases not even tried. Though most useful for the
breast, the same principle of tissue advancement and tightening can
be applied to other anatomic areas such as the jowls of the aging
face and the overhang of the panniculus or other anatomic
structures that migrate downward under the effect of gravity with
aging and volume loss.
[0003] The reconstruction of a woman's breast is an Important step
towards her recovery after mastectomy or following other
disfiguring breast pathologies. The TRansverse Abdominoplasty
Musculocutaneous flap or TRAM flap as it is most commonly called,
is one of the most common methods of achieving this purpose. It
consists of performing an abdominoplasty (tummy tuck) and then
transferring the harvested excess abdominal tissue to the chest as
a flap. Unfortunately, the TRAM flap is a major surgical procedure
that carries a substantial amount of morbidity, inflicts multiple
incisions and has a significant failure and complication rate.
While the abdominal tissue is the best available substitute for the
restoration of a breast mound, a more patient friendly, less
invasive and less complication prone method of transferring this
tissue to the breast would provide a significant societal
benefit.
[0004] While both the TRAM and the novel method described herein
take advantage of the laxity of the abdominal apron, compared to
the TRAM where the tissue is totally cut out of the lower abdomen
and brought up to the chest, this device allows the lax abdominal
tissue to slide up, to be secured in its new position and to be
molded Into a breast without having to cut it out and without any
major incision. The Invention herein preferably comprises a kit for
use by a surgeon to perform a surgical procedure to transfer the
abdominal tissue to the chest by sliding it up and fixing it in
place with a purse string of suture, and the fashioning of that
tissue into a breast mound by filling it with a small implant or
with a suitable fluid such as aspirated fat. The kit components
provide means of: [0005] 1-- Mobilizing the laxity of the upper
abdominal tissue to slide it up to the breast, [0006] 2-- Inserting
a suspension suture that is threaded from the level of the upper
chest or the clavicle, down to the upper abdominal tissue, where it
can grab its dermis/subcutaneous tissue in a purse string fashion
and then thread it back up to the level of the upper chest or
clavicle to close the loop. [0007] 3-- Using that suspension suture
to grab the abdominal tissue, pull it up and suspend it to the
clavicle (collar bone) with a bone anchor. [0008] 4-- Tightening
the suture to pucker the purse string Into a dome and firmly
securing the looped suture to the bone anchoring device using a
suture locking mechanism [0009] 5-- Percutaneously dividing the
fibers that restrict advancement of the skin just cephalic (above)
and caudal (below) to the purse string to allow a "mushrooming
effect" and fully define the breast overhang and the breast fold.
[0010] 6-- Without making a skin incision and only through a
multitude of non-scar inducing punctures, cutting the deep tissues
at the level of the new fold to define it and to induce it to
permanently heal and adhere in that new location [0011] 7--
Loosening the resultant tightness of the rest of the abdominal
tissue by mesh expanding it and dividing the restrictive vertical
retaining fibers and perforators as shown in FIG. 41. [0012] 8--
Pilling the advanced tissue with fat graft and percutaneously
re-orienting its fibrous framework in order to correct any
puckering, iron out wrinkles and treat the "double bubble"
deformities.
[0013] The steps described above are not necessarily performed in
the order presented.
[0014] The kit components could be single use, sterile, disposable,
or more permanent re-usable & re-sterilizable. Some of these
components could come inside a box kit for a specific application
or can be made available as Individual devices. While, as known to
the inventor, each of these components is novel and serves a
specific purpose for use in performing a RAFT breast
reconstruction, they are most likely useful in other related or
unrelated medical applications such as the rejuvenating face lift
and other procedures that benefit from advancing tissue beyond what
the normal tissue laxity and mobility permits.
[0015] One of these inventions may best be characterized as a
temporary bra, to be used, as appropriate, throughout the surgical
process but most preferably during surgery and then
post-operatively to maintain the shape and to prevent any recoil of
the swollen tissue. This bra is sterile and may be applied during
surgery. The bra is preferably transparent, sufficiently pliant to
conform to the breast surface and then preferably molded to the
desired shape as it is preferably strongly adhered to the skin. The
adhesive component may be inherent to the bra or shaping device
material so that it adheres upon initial contact or the shaping
device may not be initially adherent as this will allow the breast
(or other anatomic region) to be appropriately positioned inside
the device and then, when appropriately arranged inside the shaping
bra, the adhesive component might be added or made to become
active. The device may also have suspension straps or a cap bonnet
to overcome the effect of gravity. It may have a pattern of
markings on it to mark the path of the sutures and the position of
the grommets (see below) to guide the surgeon as he performs a
surgical lifting/shaping/augmentation/reconstruction on the breast.
This bra may also include a rib like structural reinforcement to
help hold its shape as it is worn by the patient. Alternatively,
the shaping device itself might be made of a material that hardens
upon exposure to air or to a catalyst, or a hardening component can
be added to it as desired by the surgeon.
[0016] To further aid the surgeon as he threads sutures through the
breast, the inventor has developed several grommet designs which
fit through the dermal tissues (and bra, if used) to identify and
isolate exit points for the sutures which aids in not only avoiding
damage to any superficial subdermal fibers and invagination
dimpling of the skin when these superficial fibers are
inadvertently held by the suture and driven inside by its
tightening, but also assists in creating an internal weave set at a
predetermined depth to support and lift the breast in a novel
surgical procedure developed by the inventor.
[0017] Thanks to the grommet, a surgeon can pass the entire needle
out through the skin, then pass the thread through the grommet,
secure the grommet in place through and over the skin puncture
site, and re-enter with the single pointed needle through the same
entrance path to avoid grabbing dermal fibers and thus grab only
the deep tissues and avoid the unwanted dimpling effect which would
potentially be created in the dermal tissues adjacent the
exit/entry point. The grommet could thus be a "salvage" for the
double pointed needle as re-entry of the needle through a grommet
threaded over the thread that has exited will prevent that suture
loop from grabbing unwanted superficial tissues.
[0018] The grommet provides an elegant alternative to the double
pointed needle as may otherwise be required. A grommet can be
inserted first through the skin around the area that needs to be
suspended and then two separate needles at the ends of the same
thread can be passed through, each circumscribing a separate path.
Removing the grommet and tightening the suture buries the loop deep
inside the tissue (at the predetermined depth of the grommet)
without grabbing dermal fibers and puckering the skin.
[0019] In addition, having two separate thread loops, each with a
different path, exit through the same grommet allows these loops to
interlock and create a basket weave that can be driven deeper
inside the breast (or other anatomic areas chosen for the
procedure) without puckering the skin and without leaving a
significant scar. A judiciously placed pattern of grommets and
thread paths is a unique and novel method of percutaneously weaving
a net-like or basket weave like supportive and shaping mesh pattern
deep inside the tissues without making any major incision, only
tiny puncture sites that tend to heal without a significant scar.
To prevent an unwanted exit through the skin and keep the grommet
securely in and across the skin opening while the needles and
threads are coming in and out, the grommet preferably has a
structure to hold it in place. To this effect, the grommet may have
threads like a screw so that it may be screwed in place.
Alternatively, the grommet could simply have a button like or barb
like design on the entry side that prevents its unintended
withdrawal, or include a retractable, telescoping "fanning out"
umbrella that would open on the undersurface of the skin to hold it
tightly in place. This additional locking mechanism would enter the
skin through the same hole, however, for the sake of keeping the
hole at minimal size, the anchoring mechanism could be spaced about
a top hat or flange in the grommet that grabs the skin through
separate fine needle sticks, fine clamps, a staple like mechanism
or even sutures. As yet another feature of the grommet, a cleat or
spiral hook may be provided to allow a suture to stay outside and
be anchored and then reintroduced into the patient's breast after
Interlocking it with another loop that also exited through the same
grommet so as to create the basket weave internal support bra
procedure described, infra and in other of the inventor's patent
filings.
[0020] As an adjunct to the grommet invention, the inventor has
also conceived of a jig or guiding mechanism that can be attached
between two or more adjacent grommets and used to physically guide
the needle as it is inserted and extends between the two grommets.
A pattern of jigs can be affixed to the supportive bra or other
shape forming device to guide the entire process of inserting and
weaving the mesh. This assists the surgeon in the delicate
procedure of guiding the needle through the deep tissues and then
the intradermal tissues of the patient as one of the surgical
procedures described herein is performed. Again, although not
strictly required, it helps transform the process from one of art
to science to thereby improve chances for a successful
procedure.
[0021] The inventor has conceived of and developed a number of
needle devices to aid him in several of his novel surgical
procedures. Among these are a needle that can be driven from a
distance to enter from one site, grab and secure tissues that are
relatively distant, and return to the original entrance point while
keeping the suture deep within the body tissue without grabbing of
any intervening skin and without causing any unwanted puckering.
This requires a needle that is significantly different than the
standard surgical needles that are used to stitch together wounds
or immediately exposed adjacent structures.
[0022] The needle preferably has a sharp point at only one end as
long as long as the procedure allows it to come in and out only
through "mature" puncture holes along its looped course. Mature
holes may be for example liposuction cannula entry holes that have
their subdermal fibers destroyed by the repeated passage of the
cannula such that an in & out passage of the needle through
this widely dissected path is not likely to catch unwanted fibers
along the way. In a surgical procedure such as the fat graft
augmentation typically performed on a patient with excess abdominal
fat, a liposuction procedure to harvest the fat for use in the
breast augmentation would provide these mature holes, for
example.
[0023] Most prior art surgical needles have pointed tips that are
round in cross section. The inventor's needle invention preferably
includes cutting tips; needle tips having a cross section with
sharp cutting edges at the pointed end to slice through the dermis.
(Surgical needles are normally classified as having either round or
cutting tips.) The needle here preferably needs to have a extremely
sharp and long beveled cutting tip that has preferably an even
sharper finer bevel to slice through the arcuate long dermal path
when it is used for the purse string procedure described, infra).
Furthermore the orientation or needle cutting tips should ideally
be such that the cuts are deep and along the inner curve and not
up, as explained infra.
[0024] Another needle embodiment is preferably double pointed.
(Though for the RAFT procedure only one of the pointed tips is
preferably very fine and cutting, the other, for the purpose of
safer manipulation is preferably round or with a shorter cutting
bevel). Double pointed needles are capable of being driven along a
complex stich course to grab and tie together deep and far tissues
(as contrasted with adjacent tissues as is typically done in the
prior art) without the attached thread ever having to exit through
the skin which tends to cause unwanted dimpling. A classic prior
art needle (sharp at one end and blunt with a thread through an eye
at the other) can only be driven through the tissue for a short
distance, and this through a relatively straight course, or one
that circumscribes only a limited arc. To go through a lengthy
course or to complete a loop and come back to its original entry
site, a standard needle has to exit the body every few centimeters,
and be driven back again through the skin to continue and complete
the path. With this process, as dictated by the typical prior art
needle, it is difficult to penetrate the skin again back through
the exact same exit pin hole, and even if it does, it is even more
difficult to follow the exact same path along the subdermal fibers.
As a result, the thread that follows will inevitably grab some skin
or some subdermal fibers along its in and out looping path, and
when tightened, the stich will almost invariably create some
dimpling of the skin at each entry/exit site. A double pointed
needle can be driven through the tissues with the first sharp point
forward like a conventional needle and have that first point come
out through the skin. But unlike the conventional needle, to
continue the complex course, the double pointed needle does not
have to completely come out through the skin. If the second point
is kept deep inside the tissue, that needle can now be handled by
the outside shaft and driven back for another bite with the second
point now forward piercing the tissues. One of non-obvious
advantages enabled by the double pointed needle invention is that
the attached thread never emerges through the skin and instead
remains at the depth predetermined by the length of needle kept
inside at each bite. This presumes a centrally located eye or
thread connection site.
[0025] There are some prior art double pointed needles previously
described by innovative plastic surgeons and are called shuttle
needles. This simple design of a straight double pointed needle
with a hole for the thread in the middle is known in the art.
However, the present Invention Improves upon this type of needle
with a number of non-obvious design modifications that provide many
more functional advantages and which adapt it to be especially
useful for the purposes described, infra. For example, some of
these differences include: Size: prior art length of 10-15 cm vs.
25-50 cm for the invention & prior art diameter 0.8-1.2 mm vs.
1.5-3.5 mm diameter. Curvature: prior art straight or simple curved
arc vs. a relatively straight central portion with a curvature at
one if not both ends for the invention. In one embodiment the
needle preferably takes a "J" shape, or in an another, a double "J"
shape. Cutting point: prior art sharp point tip with round cross
section vs. sharp point tip preferably with cutting sharp edges in
cross section and a long bevel specially oriented according to Its
curvature to allow it to slice through as it is tunneled inside the
dermis without risk of cutting the skin surface along its path. In
addition to being able to be driven from a long distance (from
infraclavicular to upper abdominal), the needle used for the RAFT
needs to maintain the suture in an even tissue plane as it is
threaded through what becomes the mammary folds is considered
Important by the inventor for desirable results. Otherwise, instead
of resulting in an even line fold, the purse-string tightening may
result in unsightly curtain like dimples, bulges and folds.
[0026] Malleability: prior art brittle hard vs. rigid but malleable
enough so its path can be steered to a certain extent along its
curved path from the outside, while it is handled from the distant
exposed end as it is pushed through the tissues and manually
steered externally along the arc and kept at the desired anatomical
depth.
[0027] In addition to the above, the inventor conceives of a family
of needles that may for convenience be categorized Into the
following types. All are preferably curved and pointed on one or
both sides. These are considered by the inventor as the
improvements and the novel features to be added to the simple
double pointed needles previously described. [0028] a-- Eye or
swaged thread insertion point closer to the needle point edges: The
previously described shuttle needles have a simple hole for the
thread (the eye) at the approximate mid-point of the needle. This
mechanically weakens the needle at its very center where the torque
is strongest while it is driven through the patient, making it
prone to breaking with a broken piece deeply lodged and causing
complications. To remedy that shortcoming in the prior art, the
inventor has conceived of an alternate modification which places
the eye close to one of the sharply pointed ends so as to reduce
the torque capable of being applied as the needle may be grasped
nearer the eye when inserted, and thereby also reduce the chance of
the needle breaking at the eye. Most if not all previously
described shuttle needles have the eye, or the attachment point of
the thread, at the middle of the needle shaft. The inventor has
made the discovery that an eye close to the pointed edge still
serves the same purpose of being able to shuttle a stich while
reducing the possible torque to be applied at the weak eye or the
suture insertion point and therefore greatly diminishing the
possibility of the dangerous complication of breaking the needle in
its middle with one of the halves deep inside the patient's
tissues. [0029] b-- Reinforcement of the needle at the eye or the
swaged thread insertion site: The second modification, regardless
of the location of the eye or suture insertion point, consists of
reinforcing the area around that weak spot to further inhibit
possible needle breakage. This reinforcement could preferably be in
the form of a metal sleeve around the eye opening, a thickening of
the needle shaft at that location, or a segment of stronger alloy
used at that particular location or otherwise. [0030] c-- Swaged
thread design: For a single use device, a present day requirement
for all modern sutures, the swaged thread design is the preferred
embodiment. The thread can be connected at one end for the single
sharp end needle embodiment or on the shaft somewhere between the
two points with the reinforcement described above for the double
sharp end needle embodiment. The thread material can also be molded
around and through the needle shaft for a more secure connection
that does not weaken the structural mechanical properties the
needle. [0031] d-- Adjustable or Marked Exit/Pivot Point: For the
double pointed needle to maintain its suture thread deep inside the
tissues and avoid skin dimpling, it is presently considered by the
inventor to be critically important to always maintain one of the
needle point tips under the skin. The opposite point should not
exit the skin while the needle shaft Is reloaded on the needle
holder and the needle shifts direction to advance and take the next
suture bite. This is delicate and trickier than it may seem, as
inadvertent minimal exiting of the second needle tip will
inevitably catch dermal fibers during re-entry, annul the advantage
of the double pointed needle and lead to failure of that entire
needle path. Furthermore, the depth at which the needle switches
direction to be driven forward again determines the level at which
the tissues are sutured. The problem becomes even more delicate
when the desired depth/level of tissue suturing is more superficial
or needs to be precisely set. Simple prior art double pointed
needles do not offer a mechanism to prevent inadvertent exit and
provide no means to gauge the depth of the needle tip as the needle
is withdrawn leaving the surgeon guessing without any objective
reference as to how much length of needle is still inside the
patient. [0032] To remedy that shortcoming in the prior art, the
inventor has conceived of placing visible graduation marks, grooves
or tiny rings on the needle shaft, preferably extending near each
end, to accurately determine how much needle is still inside the
patient, and at the same time, determine and set the depth of
suturing. [0033] d-- Stops to prevent inadvertent needle exit:
Another and perhaps even more useful additional innovation is to
place a structure on the needle shaft at predetermined distances
from the pointed tip, like a ring, a bulb, an arrowhead, or some
barbs that will function as stops to prevent inadvertent exiting
from the skin and which also function as pivot points to indicate a
change in direction. These "stops" could be placed at fixed
predetermined locations on the needle shaft, with different needles
for different applications requiring different level of suturing.
Alternatively, the stops could be slidable or otherwise adjustable
such as by being mounted on ring sleeves so as to adapt the same
needle for use with different surgical procedures. And, the stops
could also be made to retract, fold in, withdraw, or otherwise
become reduced in cross section when needed to thereby reduce the
eventual exit opening or skin puncture diameter, making it less
traumatic to withdraw the needle when it is time to do so. This
"stop" innovation provides a more objective indication to the
surgeon as he works and which helps him avoid unintended exiting,
and thereby improves his chances for a successful surgery, to both
the patient and the surgeon's benefit. [0034] e-- Needle
construction comprising two or more parallel shafts joined at the
tip that are sharpened and made into cutting tips: This innovative
needle design comprises two or more parallel shafts joined at the
tips that are rendered pointy & sharp cutting. The slit between
the two shafts provides ample room for the thread to move freely
and yet be retained and potentially wedged within the needle as it
is used. Furthermore, the thread loop knuckled at a 90.degree.
angle to the plane of the needle shafts acts like a natural stop to
prevent inadvertent needle exit and the apex meeting point of the
shafts also serves as a good anchoring or retaining point for the
thread. Of course, marked graduations to gauge depth and full
mechanical stops as described above to prevent inadvertent exit are
still useful options. [0035] f-- Needle with an opening eye, or a
slit allowing it to grab a thread segment: In this construct, the
eye of the needle can be opened to insert a thread loop, or has a
passage that allows a thread segment of loop to enter the eye when
the thread ends are not available. Contrary to needles with a
standard eye opening that can only be fed the ends of suture
threads through the eye, this novel type of needle does not need to
have the end of a thread available to grab it. When the ends are
buried or not available it can grab a thread segment or loop
through its eye and continue to suture that thread. Such a needle
makes it possible to pass a loop back through the grommet either to
close a weave path or to emerge back through another grommet
allowing for a more complex and supportive weave. A double pointed
needle with the eye that opens is a very useful tool that can take
a suture loop and weave it deep through the tissues to complete a
complex stich path. Two possible designs for the opening eye needle
invention are shown in FIG. 42. The embodiment shown in the upper
figure has a passageway providing a way to hook the suture. The
bottom figure depicts a deflectable or bendable arm that can be
deflected to allow passage of a suture therethrough and into the
eye, after which it closes to retain the suture. [0036] g-- Double
pointed needles with two eyes. One that opens and the other
standard or that already has a swaged on suture or one already with
two threads, one close to each eye. In this even more useful
embodiment the needle has two potential suture attachment sites,
one close to each end. This can allow for inserting even more
complex weaves through even more complex paths without necessarily
having the thread ever grabbing dermal fibers. [0037] h-- Needle
where the cutting edge has small sharp dissecting winglets that
ensure an even level of travel as it courses through the
subdermal/dermal tissue planes. One such example is depicted in
FIG. 45. [0038] i-- Combinations/permutations that includes two or
more of the above design innovations:
[0039] In the RAFT surgical procedure described herein it becomes
necessary to provide an anchor with a tightening device in which a
number of sutures are secured and used to adjustably lift and
support the surgically repaired/augmented breast. This could take
the form of a simple suspension hook introduced through a small
slit and guided to curve around the superior aspect of the clavicle
to hook it to the patient's clavicle. Alternatively, through a
small incision on the anterior aspect of the clavicle a curved
blunt needle can be introduced to curve around the posterior aspect
of the clavicle and emerge in the supraclavicular fossa, then
without completely coming out (Shuttle principle) follow the
postero-superior surface of the clavicle and emerge through the
anterior wound. The thread that follows would have left a loop
around the clavicle upon which the long threads can be suspended,
looping down to the upper abdomen and then locking the entire
construct at a determined level of tightness. This is the clavicle
loop alternative that requires a shorter double pointed shuttle
needle with a tighter arc of curvature, as described in more detail
in the Detailed Description.
[0040] In yet another alternative, the suspension can be done with
the help of a standard bone anchor of the type that has barbs that
open once the outer cortex is pierced to prevent pull out. Or a
bone anchor of the type that is secured as a screw through the bone
cortex may be successfully used. The anchor can be either
introduced under direct vision after making a small incision and
dissecting the tissues overlying the clavicle, or preferably
through a minimal incision using a modified drill guide tissue
dissector or a cannulated screw inserted over a previously driven
guide wire. (Such techniques are standard and well known to skilled
surgeons in the surgical art). The screw is preferably a
self-tapping screw to avoid the tapping stage required to create
the threads in the bone.
[0041] Traditional anchors have threads and needles attached to
them so the sutured tissues such as ligaments and tendons are
secured to the bone through the anchor. In this application tissues
are not sutured directly to the bone, rather the anchor acts as a
suspender for a loop that is being tightened into a purse string
and brought cephalically. One simple way is to have a strong suture
loop or a hanging washer loop connected to the anchor and then
looping the long purse string suture through that loop as it is
being tied. However, this may be found to be cumbersome and not
ideal. Adjusting the tightness of the suspension and of the purse
string by tying a knot is not precise and the secured knot leaves
behind an undesirable mass of palpable bulky tissue. And, once
secured, the process does not leave room for adjustment.
[0042] To that effect the inventor has conceived of various
alternative designs for simpler, more practical, adjustable,
elegant and less bulky results. One such concept is the use of
washers around the bone screw and by having the thread loop around
these washer rings it can be locked in place at the proper tension
and level by tightening the screw. Furthermore there are many
mechanisms by which threads can be securely locked together at the
desired tightness with a device where the threads enter a passage
or hole or loop and a screw or a cam mechanism tightens this
passage to lock them securely in place. This tightening device can
be an integral part of the anchor as a screw or a cam inside the
already screwed in anchor, in which case a guide is required for
the blind Insertion of the tightening device or screwdriver and a
thread guide passer loop is needed to pass the ends of the purse
string suture through the deep anchor. In another embodiment, the
tightening/locking device can be a separate structure connected or
attached to the anchor but with more freedom of movement so that it
can be exposed to pass the purse string loops, tighten them and
lock them in place and then the tightening/locking device can then
be buried deep inside the tissues once the suspension is complete.
Two embodiments are shown in FIGS. 43 and 44.
[0043] There are a number of alternative means of locking the
suture and suspending it to the anchor. The requirements are that
is should not be bulky so it is not visible or palpable and ideally
it should be adjustable. Thus, alternatives such as ultrasound or
heat welding the sutures together or locking them with a tightening
clip or belt-like band/washer system are also contemplated.
[0044] All of these alternatives are within the scope of this
invention.
[0045] Another alternative is having the anchor already connected
to the same long suture that is connected to the needle and leaving
a mechanism whereby after driving its looped course around the
breast the needle can pass through the anchor again or a ring on
the anchor side of the thread to thereby complete its arcuate path.
That ring could also have a crimping/screw/looping or cam locking
mechanism that would allow locking the tightness of the loop and
the suspension level.
[0046] The inventor has also conceived of a tissue mesher device
which has been found to be extremely useful in several of the
surgical procedures disclosed herein, especially in the RAFT breast
augmentation/reconstruction. For the breast surgery procedures
described infra, pulling up the abdominal tissue to the chest is
limited by the resultant tightness of the advanced tissues. The
inventor has discovered that meshing the abdominal tissue can
relieve the tightness thereby allow much more tissue to be advanced
and recruited into the breast while maintaining a tolerable low
tension to the tissues and the suspension structure.
[0047] It is known in the art that making staggered small slits
into a sheet of tissue allows it to expand. This principle is used
by children to create ornaments and in metallurgy to create metal
meshes. This is also how plastic surgeons, using a device called a
mesher, stretch small pieces of harvested skin graft and expand
them to cover much larger wound defects. However, with this
invention, instead of meshing a skin graft, the surgeon meshes the
tissues just under the skin that would otherwise restrict the
advancement of the abdominal apron. The tissue mesher preferably
consists of a number of sharp thin cylindrical rods with short
sharp cutting tips at their penetrating ends. The rods are
preferably firmly mounted in a staggered, orderly and predetermined
pattern on a handling device that can control the depth and angle
of penetration and the degree of oscillation. Oscillatory and
translational sweeps of the mesher divide at different levels
different anchoring fibers that hold the apron to the deeper
abdominal wall. Due to the orientation of the rods, these
alternating nicks do not open a tissue plane and prevent the
formation of potential cavities which would be undesirable.
Instead, as the individual fibers are cut by the rods at different
levels they slide past one another to create a complex expanding
inter-digitating scaffold. Thus without space generating slicing
cuts these combined nicks allow the abdominal apron to freely
translocate cephalically and advance into the breast.
[0048] This process also creates a healing interface so that once
healing occurs, the apron scars down to its new location and tissue
advancement is no longer dependent upon the sutures. Furthermore,
this process creates tiny interstices with loose vascularized
tissue fibers, an ideal environment with excellent graft to
recipient interface where in aggregate, large volumes of micro
tissue grafts can survive. Trauma, surgery, inflammation or
radiation leads to tissue scarring, deficiency and stiffness that
can cause disfiguring body deformities, organ dysfunction, motion
restriction, pain or unstable non-healing wounds. The traditional
treatment technique consists of surgically releasing the scar or
the fibrous constriction by making cuts typically referred to as
relaxing incisions. This maneuver provides the tissue mobility
necessary to release the contracture, advance the freed up tissue
to restore mobility or correct the contour defect or to reconstruct
the tissue deficiency. To address a more extensive scar and tissue
deficiency problem, the classic surgical solution is to incise or
excise the scar, free up the incision/excision edges and stretch
them open to create a wide gap, then fill the tissue deficiency
void by transferring a block of healthy tissue with its own blood
supply in the form of a flap. This is a major surgical intervention
and one that leaves behind a new deficiency at the site where the
flap was harvested. Unfortunately, this standard procedure of
dividing the scar with relaxing incisions has many
shortcomings:
[0049] First, the large gap created when the released tissue is
advanced leaves behind a void or a cavity that needs to be filled
in order to properly heal. This void is usually filled with a flap
of tissue; a step that often requires another major surgical
intervention whereby vascularized tissue taken from another
location on the patient's body is transferred to fill that gap.
[0050] Second, the surgical incision itself to release the tissue
leaves new permanent scars. The same is true for the site where the
flap is excised. This amounts to treating a scar with a scar
inducing procedure.
[0051] Third, this alternative does not address the stiff fibrous
scar; it only Incises it and divides it in half so that the bulk of
the scar tissue remains in its present state.
[0052] Fourth, the degree of advancement that can be achieved with
a single incision is limited.
[0053] Fifth, by also dividing the endogenous blood vessels, the
incision impairs the circulation and limits the amount of
advancement.
[0054] Attempts at excising the scar are also often futile. The
scar can be conceptually compared to a solid fibrous block of
tissue, like a brick wall separating and tightly tethering two
normal tissue compartments that are more jelly-like in nature.
Simply excising the block wall in itself induces tissue trauma that
often heals by leaving behind a new scar and often re-erects a new
wall and does nothing to address the scar tissue deficiency
problem.
[0055] There is therefore a long felt need in the art for a better
and less invasive alternative; a procedure that can truly address
the fibrous scar, the tissue deficiency, the stiffness that limit
organ function and joint motion and the body contour defects caused
by tethering surrounding tissues.
[0056] Fat grafting has been touted as a source of regenerative
tissue, and could, at the same time, address the scar and the
tissue deficiency. Conceptually, a tight scar can be incised with a
relaxing incision, its edges mobilized apart to release the
tightness and then regenerative fat grafts inserted in the gap
generated by the divided ends. A caveat is that for the injected
fat graft to survive it has to gain blood supply from the recipient
site. And as it is becoming well known in the art from the
inventors experience and teaching that only droplets less than 2-3
mm or so across can develop new blood supply to survive as grafts,
grafts collected in pocket gaps larger than 2-3 mm across routinely
die from an inability to restore circulation and thus necrose
leaving behind cysts and more scar. This is why as the edges of a
standard relaxing incision need to open up by much more than 2 mm
to achieve the needed relaxation, the larger tissue or flap
inserted needs to be a block of tissue with its own blood supply in
the form of a flap.
[0057] With the tissue mesher of the present invention, an
inventive method for addressing this issue consists of releasing
the scar or the restrictive tissue in a mesh pattern with the
tissue mesher invention to loosen it and allow it to expand into a
fibro vascular scaffold that can accept tiny tissue grafts. The
resultant construct transforms a rigid tight scar into a much
larger soft piece of healthy normal tissue. This method achieves a
novel means of tissue engineering. Meshing the fibrous contracture
(or the normal but taut endogenous fascia) with this method in
effect generates a fibro-vascular scaffold that is conducive to the
survival of large volumes of micrografts.
[0058] An important conceptual advance over the prior art, realized
with this invention, is the observation that the human body can
heal needle sticks in the 2 mm diameter range (like intravenous
lines or venipuncture sites) with no significant scar. Therefore,
while the needle tip is Innocuous in puncturing the skin, through
an oscillatory or a to and fro translational movement of the tissue
mesher, it can be made to inflict small nicks in the deeper tissues
in different planes.
[0059] Another important conceptual advance over the prior art is
the realization that a needle (or rod) cutting tip will be much
more likely to cut a tissue placed under mechanical tension than
mechanically looser tissue. To illustrate this, we can envision two
violin strings wrapped around each other. If we forcefully tighten
one of the strings and keep the other loose, a needle nick to this
construct will cause the tight one to snap but will leave the loose
one relatively unaffected. Thus, sharp pointed tips will
preferentially cut the tight scar or the fibrous tissue that is
pathologically tight or placed under tension by the forced
advancement while sparing the looser tissues such as nerves and
blood vessels.
[0060] These two conceptual advances put together allowed the
inventor to develop the percutaneous tissue mesher invention and
method as a means of bringing about the tissue advancement
alternative to the flap that is usually required in the prior art
for plastic reconstructions.
[0061] There is a natural limit to how much tissue can normally be
advanced in order to close a wound defect, release a tight
contracture or create a breast mound. This is due to the fibrous
attachments between the skin and the deep immobile tissue layers
such as the fascia underneath. These restrictive tissues can be
collectively called the subcutaneous aponeurosis. Trying to advance
the skin beyond the natural laxity limit of this subcutaneous
aponeurosis places these structures under tension rendering them
much more susceptible to being nicked by a needle tip and thus
separated than the surrounding tissues. Thus, without causing
visible skin scars, judicious percutaneous nicking of the
subcutaneous aponeurosis can mesh expand the restrictive
tissues/structures and facilitate the tissue advancement required
for a reconstruction that would have otherwise required a distant
flap transfer.
[0062] This "needling" of the deep tissues that does not leave a
skin scar Is useful in the release of Dupuytren contractures and
other scar contractures. The needling meshes the tight tissues that
cause the contracture and expansion of the meshed construct
lengthens the contracture to regenerate the tissue needed to
relieve it.
[0063] Yet another conceptual advance is the realization that the
meshing pattern can be designed and gauged to create small
interstices that can take advantage of the regenerative ability of
tissues or become good recipient scaffold for fat grafts or other
regenerative tissue grafts. The multitude of 2 mm or so gaps
created by the meshing makes room for a multitude of tiny 2 mm or
so graft droplets to survive. Fine meshing also takes advantage of
the natural regenerative ability of live tissue. This is pertinent
as tiny gaps in the body tend to spontaneously fill in and
regenerate tissue if the space and the proper milieu are
maintained. (This is how when we cover a wound with a meshed skin
graft, the gaps eventually coalesce to from a new skin sheet that
completely covers the wound). The small gaps might then fill up by
themselves if kept open and prevented from collapsing again.
Alternatively, these gaps can be filled with substances with
regenerative potential such as platelets rich plasma, solutions
containing growth factors, stem or other cells, or even just fat.
The gaps can also be filled with allograft preparations which in
themselves have regenerative potential.
[0064] One of the means to keep the tissue under stretch after
filling the recipient area with fluid (tumescence) is to apply a
relatively stiff splint, as previously described in a related
patent application. This is also another means of keeping the
meshed space open and to invite the natural regenerative abilities
of the tissue to fill the thousands of microcavities, which in
aggregate would represent substantial volume of tissue gained
naturally by using the endogenous abilities of the body to
regenerate across tiny gaps. Thus a judiciously performed meshing
followed by appropriate splinting might allow the generated
construct to fill in with healthy regenerated tissue instead of
scar tissue that will have a tendency to subsequently contract and
negate some of the benefit of the meshing.
[0065] It is also conceived that the meshing or expansion process
does not necessarily need cuts induced by a sharp instrument.
Forced tumescence by internal hydrostatic pressure can separate the
native fibers to expand tissues in a similar fashion. Therefore it
is contemplated that tumescence, as an adjunct or alone, can also
be used to expand the tissue and generate an extracellular scaffold
matrix with a multitude of tiny gaps. This matrix could then be
induced to regenerate the tiny gaps on its own or with the help of
added regenerative agents such as autografts, stem cells,
allografts or otherwise.
[0066] The inventor has found that the length of the nicks and
their spacing will determine the amount of expansion that can be
achieved. Too aggressive a meshing will destroy the circulation,
leading to ischemia and necrosis. It can also tear the deeper
tissues and result in the creation of excessively large cavities
Instead of those of a delicate fibrovascular recipient scaffold.
Excessive meshing destroys the integrity of the scaffold and leads
to excessive numbers or sizes of cavities. Too many or too large
cavities are to be avoided because tissue grafts lodged inside a
cavity are far from the capillaries of the recipient tissue and
will die from failure to re-vascularize. Therefore the inventor
realizes that since the meshing ratio is limited, it is the amount
of tissue that is meshed that determines the amount of tissue gain.
In practical terms, from experience the inventor has found that a
meshing ratio preferably up to about 20% achieves the desired
results while more than about 30% will usually lead to undesirably
wide gaps and cavities in which fat grafts will die. Using the
20-30% ratio, this means that to gain 2-3 cm of tissue, an area
about 10 cm long will need to be meshed.
[0067] The mainstay of tissue engineering consists of seeding
scaffolds with cells. The current practical limitation of tissue
engineering is not the cells, as these are readily available from
simple liposuction or from tissue cultures, but the three
dimensional supporting scaffold with functional blood capillaries
connected to the circulation of the recipient. This is why to the
best of the inventor's knowledge currently available tissue
engineered products are limited to a few cell thick alloplastic
constructs that can survive by diffusion such as dermis or cornea.
It is the inability in the prior art to build a fibrovascular
scaffold (fibrous scaffold with capillary circulation) in the
laboratory and connect it to the recipient blood circulation that
limits the ability to build three dimensional solid organs or
blocks of tissue.
[0068] This invention and method, however, is akin to tissue
engineering. It creates in situ a fibro vascular scaffold out of a
restrictive aponeurosis or a block of scar tissue and it seeds this
vascular construct with healthy cell grafts. As the droplets of fat
(or other regenerative seeded cells or reagents) engraft and mature
in this new scaffold, the effective result is the generation of new
fibro-fatty tissue. The inventor calls this novel procedure PALF
for Percutaneous Aponeurotomy & Lipo-Filling. This is the
inventor's novel and non-obvious regenerative alternative to the
classic FLAP tissue transfer. In this investigations, the inventor
has successfully performed a PALP procedure to patients that would
have otherwise required a FLAP procedure to achieve the necessary
plastic reconstruction and the results are successful.
[0069] The tissue mesher used in this procedure preferably consists
of an array of needles that are fixed on a flat or slightly curved
platform and that can penetrate the skin at various predetermined
depths and may be oscillated or translated laterally to nick the
deeper aponeurosis under tension. In various embodiments, the
needles may be permanent sharp points or replaceable cartridges
consisting of an array of sharp points, or commercially available
hypodermic needles that can be loaded and tightened into the device
at varying depths or with varying length needles or rods. The
needles are preferably arranged on a supporting device in a
staggered fashion and may preferably be organized either in one or
more longitudinal rows or even more preferably in a singular,
triangular, quadrangular, hexagonal, more rounded fashion depending
upon the specific application and requirements. Three AI blocks,
screwed together, with 3-19 holes, clamping hypodermic needles at
varying depths ranging from 1/2 cm to 3 cm, alternating a cm apart,
may be preferably used. If only a two dimensional PALF is desired,
then all needles/rods can be the same level, but if three
dimensional it would be preferred to do multiple levels. The
hexagon pattern is preferred, but others work as well, depending on
patient anatomy.
[0070] The edges of the device, or the entire plane upon which the
device pins are mounted may also be rounded or partially spherical
to facilitate the rocking or oscillatory motion needed to nick the
underlying tissues.
[0071] The tissue mesher may also be either fixed and cause the
deep tissue nick with a translational motion of the skin surface.
Or it can be designed such that when placed against the skin, a
hinge mechanism allows the needles to oscillate around one or more
axes or a ball like joint or equivalent. The sharp cutting tips can
either be constructed out of solid shafts with sharp pointed and
cutting tips or alternatively hollow hypodermic needles. If
hypodermic needles are used to deliver the graft in a controlled
fashion, they may be connected to a pump/syringe system. The
hypodermic embodiment connected to a pump/syringe system is
considered by the inventor to be ideally suited to deliver the
graft in a controlled, diffuse and evenly distributed fashion
throughout the topography of the recipient.
[0072] Stops may be provided to indicate a penetration at
pre-determined depths. Or the tissue mesher may have an adjustable
stop platform that determines the level of penetration.
[0073] One embodiment for the tissue mesher, labeled as a
Rigottome.TM. mesher, is preferably a surgical instrument with a
number of thin cylindrical rods that have short cutting tips at
their apex. It may be introduced percutaneously (through the skin)
to create a specific alternating pattern of multiple small cuts
throughout the deep subcutaneous tissues, in accordance with the
method described herein. Depending upon the specific technique
used, the Rigottome.TM. mesher can generate a two or
three-dimensional mesh of potential spaces Inside a sheet or a
block of tissue. When placed under tension the meshed tissue
expands in one or two dimensions to open up these potential spaces
into tiny cavities. Mesh expansion generates a beehive type of
construct for the 3D mesh or a wire mesh construct of the 2D mesh.
The tension could be an externally applied mechanical force or an
internally induced tumescence such as can be achieved by injecting
a fluid. That fluid may include normal physiologic solutions,
regenerative reagents, or a suspension of cells or tissue grafts
that can fill the tiny created cavities to successfully engraft.
Other materials that can be added include processed allografts able
to regenerate tissue after being inserted Inside the matrix.
Depending upon the technique, the process allows the 2D linear
expansion of a sheet of tissue where the Interstices can be filled
with fluid or graft, or a 3D volumetric expansion of a block of
tissue into a larger block with the multiple tiny generated
cavities filled with larger amounts of fluid or graft. This process
transforms a solid sheet (2D expansion) or a solid block of tissue
(3D expansion) into a recipient scaffold consisting of a multitude
of tiny cavities into which very large graft volumes can still
maintain the critical 2 mm graft to recipient interface required
for revascularization and survival. A solid block turned into a
looser and larger framework with large numbers of staggered
interstices where the injected graft can survive.
[0074] As a result of transforming a solid block or a sheet into a
recipient structure, large volumes of fluid or graft can be infused
inside that tissue with the expectation that the graft will
survive. The method transforms a solid block into a loose graft
recipient scaffold, or a restrictive cicatrix into a regenerative
matrix. The tight fibrous cicatrix becomes larger, and by becoming
filled with healthy fat graft, or by healthy new regenerated
tissue, it becomes more like the surrounding tissue. Depending upon
the density of the scar, one or more sessions can make the scar
totally disappear.
[0075] The general application of this novel principle is not
believed by the inventor to be limited to scar tissue. The inventor
considerers that any block of tissue, whether an internal organ
such as liver or kidney or whether muscle or fatty or normal can be
meshed and expanded to create tiny gaps that the body can
regenerate either naturally if the gaps are small enough and
maintained open or with the help of instilled reagents such as the
ones mentioned above.
[0076] To mobilize the abdominal panniculus and allow it to advance
cephalically we not only need to expand as described above, but we
also need to free it from its anchoring fibers to the deep
attachments. Realizing that the apron has already been mobilized to
a certain extent by the crisscrossing tunnels of the liposuction
cannula, what still prevents advancement are the residual anchoring
fibers that the normal cannula does not cut. What is necessary at
this stage then is to divide these fibers and/or mesh advance the
fascia that is anchoring their origin.
[0077] Yet another invention conceived of by the inventor is a
tissue dissector. The meshing of the deep anchoring fascia is
performed with the tissue mesher described above. But the inventor
has discovered that while meshing provides some advancement it is
sometimes not enough and more is needed. To that effect a device is
needed that will snare and avulse and cut these vertical fibers
which anchor and restrain the tissue from significant relative
movement. The inventor has found that such a device designed to
hook and avulse perforators and vertical fibers that prevent
vertical swelling when tissues have been horizontally stretched but
vertically restrained (such as what happens to tissues overlying
long standing breast implants or tissue expanders) is needed. One
embodiment for such a device is a thin long metal rod that could be
solid or hollow, to simultaneously allow aspiration or injection.
Its external surface is preferably rough like a rasp with sharp
points or ridges or, if necessary, the inventor envisions that it
could be more aggressive and have hook like or shark fin like
winglet extensions for snaring the vertical perforator fibers.
These winglets are preferably arranged radially around the shaft or
in one side or plane of the shaft depending upon the specific
dissection needed. The tip of the device is preferably round or
flat round spatulated, but preferably not pointed or sharp so as to
remain in the subcutaneous plane and not puncture the skin
superficially nor the deeper muscle tissue and viscera. The device
is preferably thin enough to be introduced through a needle
puncture in a concealed corner of the tissue that needs to be
dissected and elevated. Thickness preferably varies from 1.0 to 3.5
mm. The inventor contemplates that thinner rods will not have
enough mechanical torsional strength to do most jobs and thicker
ones will leave more noticeable scars at the entrance points. The
device preferably has four portions: a short smooth round or
spatulated tip that can tunnel through the tissues while
maintaining the device in the selected plane; This part can vary in
length from 0 to 1 cm. An active portion (the length with ridges or
teeth or dissecting hooks/fins); this part can vary in length from
1 cm to 30 cm, depending upon the application. An Inactive smooth
proximal portion without roughening that will not damage the
entrance site during the to and fro, oscillatory or other movements
required to release the tissues; and an ergonomically fit handle
portion, though a strong clamp gripping player could substitute for
that portion. Depending upon the patient's anatomy and the task
required, the active portion could be from about 2-3 cm to about
20-25 cm long.
[0078] A related Invention conceived of by the inventor is a
subcutaneous tissue rasp and dissector. There are a number of
conditions where the tissues are lax and where tissue tightening is
necessary and beneficial. This includes pathologic conditions where
ligaments, tendons, fascia and many other deep structures stretch
out or become attenuated. Tightening of the skin is also the
mainstay of plastic surgery. Facial wrinkles are ironed out and the
lax skin is tightened in the common facelift rejuvenation
procedures. Tissue tightening is also required to lift backup what
gravity has stretched out over the years. Examples Include facial
jowls, ptosis of the breasts and overhanging abdominal
panniculus.
[0079] Tightening the tissues currently requires a surgical
intervention to dissect the lax tissue, redrape or re-tighten it to
the desired position and resect the excess lax tissue and/or suture
plicate the laxity. It is also well known that post inflammatory
healing deposits scar tissue that has an inherent tendency to
contract. Therefore, to bypass the invasiveness of surgery, a
number of devices in dermatology and plastic surgery have been
designed to achieve and deliver a controlled deep
dermal/subcutaneous tissue injury that leads to inflammation and
subsequent healing with scarring and fibrosis that cause the
desired retraction and tissue tightening. Most of the devices as
known by the inventor deliver the active agent in the form of laser
light, focused ultrasonic energy, radio-frequency energy, or
thermal energy. They include many complex design features to ensure
that the superficial tissues are protected while it is only the
deeper ones that will absorb the energy and will be affected. (What
is sought to be avoided is the delivery of the injurious energy to
the epidermis and most superficial dermal layers which will cause
blistering and subsequent visible unsightly scars). These devices
were mostly designed to treat the wrinkles of the aging face.
Unfortunately, these devices have limited effectiveness; proof is
that despite years on the market, they have not replaced the
surgical facelift operation.
[0080] The effectiveness of these devices is limited by their
inability to safely deliver the amount of injury to the deep dermis
and subcutaneous tissue that will result in the required scar
retraction while completely sparing the more superficial delicate
tissues from the injurious agent. Since the distance between these
two tissue layers is of the order of millimeters and fractions of
millimeters, even a limited scatter of the most precisely focused
agent is bound to cause collateral damage. This is particularly
obvious since the injurious agent is delivered from the outside
surface and therefore has to travel through the delicate
superficial structures without Injuring them before reaching the
layer that need to be treated.
[0081] As an alternative to these prior art devices, the inventor
has developed a subcutaneous tissue file or rasp that can directly
mechanically abrade deep tissues and in a precise and controlled
fashion to cause scarring to the abraded tissues without affecting
the more superficial tissues above as well as the more delicate
external surface of the skin. This invention allows the surgeon to
manually deliver in a controlled fashion a mechanical abrasive
injury exactly where it is needed to the inner internal surface of
the skin, causing it to scar down and contract as desired to
achieve the tightening and lifting of the treated tissues. To be
most effective, this abrasive injury is delivered to tissues that
have already been loosened and partially separated and mobilized
from their anchoring deeper structures, a step that can be achieved
by the tissue dissector described herein. The inventor realizes
that the structures to be tightened need to be first dissected and
mobilized free with the tissue dissector and then allowed to
redrape and made to contract with the tissue abrader. The
percutaneous tissue dissector and the percutaneous tissue abrader
are related devices consisting of a thin long relatively stiff rod
of medical grade material which differ by the design and
aggressiveness of the teeth or ridges built along their functional
part in a continuum going from the least abrasive tissue file with
ridges, to the tissue rasp with needle like teeth to the most
aggressive tissue dissector with barbs or fins that act as a saw.
An important feature of these devices is their overall external
diameter that is thin enough so that they can be introduced through
needle punctures in the 2-3 mm range. Puncture sites that require
no sutures to close and essentially leave no scar. Thus while the
central rod is limited in OD, the barbs or fins could be
retractable with a mechanism that pushes them out once the file is
introduced through the narrower puncture site.
[0082] Furthermore, to be most effective in and to obtain the best
retraction, the abraded tissue should be redraped over the deeper
structures and kept loose under no tension till the healing process
that takes a few weeks causes it to retract and scar down in the
new position. This can be achieved in two means or a combination of
these two. [0083] 1-- Applying an external adhesive supporting
structure such as a thin adhesive supportive bra in the case of the
breast or an adhesive supportive, repositioning mask in the case of
the face. This post procedure bra or holding and molding device
preferably can stay in place for the required few weeks, or is
easily replaceable till the tissues scar down. [0084] 2-- Inserting
supportive sutures that stay deep and serve to reshape, plicate,
contract or suspend the deep tissues. These sutures are best
inserted with the double ended needles and the grommets described
herein and as needed suspended with the anchor and tightening
devices also described above.
[0085] In a preferred embodiment, the device preferably consists of
a thin solid metal probe (or a hollow cannula that can also deliver
fluids or tissue and cell suspensions if needed) that can be
inserted through a few puncture sites or tiny hidden incisions and
then be tunneled under the skin to where the tightening or
dissection is desired. The rod preferably has a blunt, round
hemispheric tip to prevent it from inadvertently puncturing tissue
planes or a round spatulated tip to dissect the tissue planes
without puncturing through them. Some of the fins or barbs can be
designed such that they are retractable by a screw or an internal
push mechanism. The mechanical abrasion can be manually performed,
or alternatively the filing motion can be delivered by an external
mechanical source that either pistons back and forth, in and out,
and/or rotate or oscillate. This internal skin file device is
completely different from other prior art file and rasp devices in
that it is a thin rod of medical grade material that has relatively
sharp fine ridges along its active portion and may have an inactive
portion, if desired.
[0086] It is also understood that to perform such a dissection, the
tissues often need to be primed with a tumescent infusion that can
help open up the tissue planes, put the restrictive fibers under
tension and thus more prone to avulsion, and cause vasoconstriction
that will prevent bleeding from the avulsed vessels. External
traction could also provide an alternative/supplement to the
tumescent infusion.
[0087] Yet another related invention addresses the problem of
breast ptosis. Breast ptosis, is the drooping of the breast from
acquired laxity of the supporting ligaments and the skin envelope
of the breast it Is the most common deformity of the female breast
and virtually all women will develop some breast ptosis with age.
It is estimated that over 100,000 surgeries alone are performed in
the USA to correct this deformity. Ptosis is classified according
to the relationship between the nipple and the inframammary fold.
In the non-ptotic breast the nipple is above the level of the fold.
In grade one ptosis, the nipple is at the level of the fold; grade
two, the nipple is below the fold; and grade three, the nipple is
the lowermost structure of the breast.
[0088] While minor degrees of ptosis, can be corrected by filling
up the stretched out skin envelope with an implant, larger degrees
of ptosis require re-tailoring of the skin envelope to bring the
nipple back to above the level of the Inframammary fold and to
restore the hammock-like supporting effect of the lower pole breast
skin. This tailoring operation requires multiple incisions to
remove (or plicate) the excess skin and therefore leaves behind
unsightly scars. These incisions and scars are believed to be the
reason why the overwhelming majority of these deformities are never
sought to be corrected. Therefore a device and method that could be
used to surgically correct breast ptosis without incisions or scars
would be a very useful.
[0089] Women with ptotic breasts typically wear a support brassiere
for most of their waking hours for at least cosmetic reasons. Some
stick-on brassieres have recently been developed where, as the
adhesive tape plicates and folds in the excess skin, a normal
breast contour is restored.
[0090] The main problem in breast ptosis is the excess skin and
laxity of the internal suspensory ligament (also called ligament of
Cooper). Excess skin in the vertical dimension along with vertical
elongation of Cooper's ligament causes a loss of the suspensory
effect and brings the nipple down. Excess skin in the transverse
dimension along with laxity of Cooper's ligament causes a loss of
the hammock-like support of the breast permitting it to fall
further. Therefore the skin and the ligaments need to be tightened
in two dimensions in order to restore both the suspension and the
hammock. To remedy this issue, the inventor has conceived of a kit
and a method of surgically inserting a permanent, preferably woven,
brassiere under the breast dermis to restore the supporting
ligaments, to reconstruct a hammock, and to induce the skin to
shrink.
[0091] The kit device preferably includes: [0092] 1-- A bone
anchor, in order to secure the breast to a solid fixed anatomical
structure. That anchor is preferably inserted in the sternum, the
ribs or the clavicle. The threads weaved into the breast as
explained below connect to this anchor. [0093] 2-- Threads, that
are surgically tunneled subcutaneously and weaved inside the breast
to restore the ligaments and the hammock. These threads could be
made of suture materials commonly used in surgery or preferably out
of synthetic, allogenic or alloplastic materials that favor their
ultimate transformation into fibrous ligament. Preferably, the
threads are also color coded such that each thread has a different
color to facilitate the recognition of the ends of each thread as
they are tightened during the surgery. The inventor has found that
a typical procedure would preferably be expected to require 6-12
threads of different length. [0094] 3-- Special needles, to drive
these threads. The needle is preferably curved, double pointed with
graduation marks near the pointed tip that indicate the level of
penetration, and with the thread swaged in the middle or close to
one of the sharp points. Another type of needle that may instead be
used is one where the eye can be opened to allow the insertion of a
loop. Yet another needle is one that includes a stop to prevent
inadvertent exit as it is shuttled through the tissues. These
needles may be the same needles as described above. [0095] 4-- A
brassiere, that can be applied sterile on the operative field as a
surgical aid. This brassiere is considered by the inventor as an
important element of this invention. After restoring the normal
anatomical relationships of the breast architecture like a
well-fitting brassiere would, the brassiere desirably becomes
adhesive and sticks to the skin and becomes relatively plastic or
rubber-like hard. The brassiere is preferably transparent or
translucent in order to allow monitoring of the status of the
underlying skin and to insure that the brassiere is still adherent.
The brassiere also preferably has marked on its surface the
preferred pattern of weave that the threads should follow, to
thereby guide the surgeon during the operation. The external
temporary brassiere provides static support for the breast while
the weave is surgically formed so that the individual threads are
passively weaved and their loops locked at the appropriate length
without being under tension in the process. [0096] 5-- An important
attribute of this brassiere is its ability to hold the breast in
the desired shape and suspend it in the desired position. It is
also preferably rigid and well adherent to the skin such that
snugly pulling the threads that constitute the weave locks them all
at the ideal length and tightness for an even contour. If the
brassiere is not adherent or not stiff, some threads might be
tightened more than others to cause unsightly dimples. In essence
therefore it is this brassiere that primarily determines the length
and tension on the individual threads of the construct to make it
even. [0097] 6-- Preferably needle sleeve grommets, that fit around
the needle as it emerges out of the skin and become the guide for
the needle when it is reinserted again into the skin. These
grommets keep the threads and the weave in the deep tissue planes
as the needles come in and out of the skin, preventing the suture
loop from catching dermal fibers as they perform the weave. This
needle sleeve grommet is also considered by the inventor as an
Important and innovative part of the invention. Without these
grommets, a shuttle needle (a double pointed needle with the eye in
the middle) has been found by the Inventor to only perform a simple
circum-mammary loop. With the grommet keeping the skin/subcutaneous
tunnel open, a loop of thread can stay outside and then Interlocked
with another loop coming out of the same tunnel so that the
Interlocking weave pattern can be performed and brought back down
inside the deeper planes where it does not result in visible skin
dimples. [0098] 7-- Preferably a crimpling/locking device, that
adjusts the length of each of the Individual supporting threads as
a function of its path along the stretched out skin envelope. This
crimpling or locking device eliminates the need for the standard
tying of knots. This prevents leaving behind a suture knot bulk and
makes it easy to appropriately adjust the length and tension of the
threads. The final exact adjusted length of each individual thread
weaved through the breast has been found by the inventor to be
important to the success of this procedure. The multiple threads
preferably function together to distribute the support evenly among
themselves in order to prevent dimples and contour irregularities.
[0099] 8-- Optionally, special dissector cannulas and liposuction
and lipografting cannulas, if desired.
[0100] With this kit device and the method of application described
herein, an internal brassiere can be surgically constructed
subcutaneously to support the breast and lift it up to restore its
normal aesthetics. Most Importantly, the procedure leaves minimal
scars as there are essentially no incisions and no sutures marks,
only needle size puncture holes which heal leaving virtually no
scarring.
[0101] An alternative to this inserted weave pattern is an external
supportive shaping brassiere that firmly adheres to the skin after
the dissection with the rasp is performed and can be worn for the
long period of time necessary for the tissues to heal in the new
location and for the dissected skin to retract to the new envelope
shape imposed by the brassiere.
[0102] The inventor also has conceived a similar device and method
to re-drape the stretched skin and jowls of the aging face. Double
needles such as the ones described above can be used to insert a
pattern of deep suture that can tighten or suspend the tissues. A
supportive mask or bonnet is also Included that can
supplant/replace the sutures once the percutaneous dissection of
the skin and its stimulation to retract are induced with the rasp
and the file.
[0103] While many of the advantages and features are briefly
described above, a more thorough understanding of the invention(s)
may be gained by referring to the drawings and the Detailed
Description of the Preferred Embodiments which follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0104] FIG. 1 is a side view of a grommet invention, inserted
through a patient's skin, and detailing a flange and retainer;
[0105] FIG. 2 is a side view of a grommet invention, inserted
through a patient's skin, and detailing thread tie off
structures;
[0106] FIG. 3 is a side view of a grommet invention, inserted
through a patient's skin, and detailing a flange with securing
structure;
[0107] FIG. 4 is a perspective view of a jig extending between two
adjacent grommets to guide a needle from one grommet to the
other;
[0108] FIG. 5 is a side view of a double pointed needle of the
present invention, with an eyelet at one end thereof;
[0109] FIG. 6 is a partial view of several variations of the needle
invention, with cross sectional views detailing their different
embodiments;
[0110] FIG. 7 is a perspective view of a double shaft needle
embodiment with double pointed ends, with cross sectional views
detailing different possible shaft shapes possible for use;
[0111] FIG. 8 is a top view of a double shaft needle with a central
thread shuttle;
[0112] FIG. 9 is a side view of a double pointed needle with
central reinforcement and graduations marked on an end;
[0113] FIG. 10 is a side view of a double pointed needle with
reinforcement depicted at an eyelet, whether positioned in the
middle or at an end of the needle;
[0114] FIG. 11 is a partial view of a needle end inserted through
the skin with a stop to prevent inadvertent exiting of the needle
during the surgical procedure;
[0115] FIG. 12 is a partial view of a needle end inserted through
the skin with a different design stop;
[0116] FIG. 13 is a perspective view of a needle end with a
retainer threaded onto the needle to provide an adjustable
retainer;
[0117] FIG. 14 is a partial perspective view of a needle end with a
threaded retainer comprising retractable umbrellas;
[0118] FIG. 15 is a partial perspective view of a needle end with a
slidable retainer comprising retractable umbrellas;
[0119] FIG. 16 is a partial perspective view of a needle end with
an arrowhead stop and depicting alternate eyelets for the
thread;
[0120] FIG. 17 is a perspective view of a "J" shaped needle as used
in a RAFT breast augmentation/reconstruction procedure, with thread
swaged onto one end thereof;
[0121] FIG. 18 is a side view of two alternative stops for use with
a "J" shaped needle;
[0122] FIG. 19 is a partial cutaway view of a bone anchor detailing
the sutures gathered through a ring with the anchor secured to the
clavicle;
[0123] FIG. 19 (a) is a perspective view detailing the bone anchor
and various alternative embodiments thereof;
[0124] FIG. 20 is a partial view of an end of a tissue dissector
and rasp;
[0125] FIG. 20 (a) is a partial view of the working ends of various
tissue dissector and rasp alternate embodiments;
[0126] FIG. 21 is a perspective view of a first embodiment of a
tissue mesher invention comprised of three rectangular solids
screwed together with needles extending through a matrix of eight
holes;
[0127] FIG. 22 is a plan view of a second embodiment of the tissue
mesher with a matrix of nineteen holes;
[0128] FIG. 23 is a perspective view of a third embodiment of the
tissue mesher arranged in a sliding framework to provide lateral
translation of the needles;
[0129] FIG. 24 is a partial view of several articulated joints to
permit lateral translation of a tissue mesher or grommet jig;
[0130] FIG. 25 is a partial view of several articulated joints to
permit lateral translation of a tissue mesher or grommet jig;
[0131] FIG. 26 is a partial view of yet another articulated joint
to permit lateral translation of a tissue mesher or grommet
jig;
[0132] FIG. 27 is a side view of a rack and pinion drive for a
tissue mesher to provide lateral translation of the needles;
[0133] FIG. 28 is a plan and side view of a tissue mesher with yet
another matrix of needles;
[0134] FIG. 29 (a)-(g) are frontal views of a patient detailing the
method of performing a RAFT breast augmentation/reconstruction;
[0135] FIG. 30 is a side view of a normal breast, detailing the
vertical connecting tissue otherwise restricting abnormal cephalic
movement of the upper abdominal tissue;
[0136] FIG. 31 is a side view detailing the cephalic sliding
permitted as the vertical connecting tissues are "nicked" by a
tissue mesher to break;
[0137] FIG. 32 is a side view detailing how the abdominal tissues
mushroom as the RAFT procedure completes, with the vertical
connecting tissue released;
[0138] FIG. 33 (a)-(c) are side, cross sectional views detailing
the method of performing a breast lift using the tissue dissector
and tissue rasp inventions;
[0139] FIG. 34 is a cross sectional view of the breast with the bra
supporting it, a pair of grommets inserted over the needle and
through the bra with thread passing through one of the
grommets;
[0140] FIG. 35 is a cross sectional view of the breast and bra,
with a grommet having a shoulder to hold it in place in the bra and
a pair of threads looped together to start the weave;
[0141] FIG. 36 is a perspective view of the basket weave result
achieved through use of the invention, the basket weave being woven
in place subcutaneously in the breast;
[0142] FIG. 37 is a perspective view, with the breast in phantom,
depicting the basket weave in relation to the breast as it is
formed inside the breast;
[0143] FIG. 38 is a side view of the shuttle needle, with
graduation marks near each end and a thread through a centrally
located eye;
[0144] FIG. 39 is a cross sectional view of the breast with bra,
and the needle inserted through one of the grommets and into the
breast with a thread being threaded through the breast;
[0145] FIG. 40 is a cross sectional view of the shuttle needle
inserted through grommets at each end and showing the thread looped
through one of the grommets;
[0146] FIG. 41 depicts in several views the use of the
Rigotome;
[0147] FIG. 42 depicts the needle with opening eye;
[0148] FIG. 43 depicts a clavicle suture fastening, double ring
embodiment;
[0149] FIG. 44 depicts a clavicle suture fastening, fixture
embodiment; and
[0150] FIG. 45 depicts a needle embodiment with ailerons or wing
extensions.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0151] As shown in FIG. 1-3, a grommet 20 includes a central,
cylindrical shaft 22 preferably with a top hat, annular flange 24
for engaging the skin surface as it is inserted into an incision in
the patient's skin. The cylindrical shaft 22 preferably has a
beveled tip 26 to aid in its insertion and which provides
directionality for locating and threading therethrough a needle and
thread, as is explained in greater detail below. Various
embodiments of a stop 28 are depicted, as follows. As shown in FIG.
1, a collapsible pair of wings 30 may extend from the sidewall of
the shaft 22, and which open to block unintended removal or exiting
of the grommet 20 during use but which may be collapsed to
facilitate its removal, when desired. Two other embodiments of a
stop 28 are depicted in FIG. 4 and include a collapsible umbrella
32 extending from the flange 24. Or, as yet another alternative,
the flange 24 may be provided with a series of holes 34 through
which a suture, pin or other structure 36 may be inserted either
parallel or oblique to the shaft 22 to secure the grommet in place.
As depicted in FIG. 2, a threaded loop or suture securing or
retaining structure comprising a cleat 38 around which the thread
(not shown) may be wrapped much like a marine grade cleat.
Alternatively, a spiral hook 40 may be provided through which the
thread (not shown) may passed and wrapped around to the same
effect. Thus, with the grommet 20, a designated opening, or
incision, is reliably located and which is "clear" of surrounding
tissues which might otherwise be undesirably caught or snagged as
the needle and thread is passed therethrough.
[0152] As shown in FIG. 4, a grommet jig 42 may be secured to two
adjacent grommets 20 to guide a needle 44 and attached thread 46
from one grommet 20 to the next grommet 20 during the RAFT
procedure as described herein, or for any other surgical procedure
requiring a suture to be implanted between adjacent grommets 20 or
incisions. The grommet jig 42 generally comprises an articulating
or swivel mounted fixture 48 at each grommet location and a fixed
bar 50 extending therebetween. There are various structures and
construction details indicated and shown in FIG. 4, the details of
which would be apparent to those of skill in the art.
[0153] As shown in FIG. 5-18, a number of embodiments with
alternative novel and unique features of surgical needles are
depicted for use not only in the RAFT and PALF procedures but also
for general surgical use. These are typically made of surgical
stainless steel for reliable sterilization and as would be known in
the art. Several of them have cutting edges and points in various
configurations although others, as known in the art could be used
as well. At least one needle is specially configured for the RAFT
procedure and its specific use will be explained.
[0154] Referring now to FIG. 5, a generally curvilinear, double
pointed needle 52 has an eye or eyelet 54 located near an end 56
through which thread may be passed when used, or which may have
thread swaged thereat for a single use needle 52. FIG. 6 depicts
various alternative cutting points which may be used as desired or
as indicated for a particular procedure. As shown, a round point 58
has a circular cross section and which is especially suited for
creating a smooth entry hole. A cutting point 60 with a long bevel
62 provides a trilateral cutting edge 64 for opening up a wider
incision. A knife or blade tip 66 provides a bilateral cutting edge
68 which will cut through the tissues more evenly and assists the
surgeon in dissecting the tissue planes, and maintaining the
relative position of the needle with respect to the tissue planes.
Staying level and staying in the same plane is helpful in avoiding
the gathering of tissues, similar to drawing a curtain together,
while preforming the "purse string" RAFT procedure as described
herein. FIG. 7 depicts a particular construction of a curved needle
69 as has been used by the inventor. As shown, a pair of shafts 70
are joined at their ends 72, such as by swaging them together,
leaving a longitudinal gap 74 therebetween and through which a
thread 76 may be Inserted. The ends 72 are sharpened into points as
shown. The shafts 70 may have different cross sections, such as
being a simple rectangle 78, semi-circle 80, or circle 82 and be
suitably used for this construction along with many other shapes.
With this construction, the thread 76 may be left free to slide
along the length of the needle 69 as it is used, or it may be
swaged or otherwise attached anywhere along its length, as desired.
FIG. 8 depicts a straight, double pointed needle 84 formed from a
joined pair of shafts 86, as before. However, additionally, a
centrally located passageway 88 is formed between the shafts 86 and
a shuttle 90 with an attached thread 92 is positioned within the
passageway 88 so that it may freely slide from end of the needle 84
to the other as it is used. Alternately, the shuttle 90 and
passageway may be provided and be crimped into place by the surgeon
to suit his individual preference depending on his technique, the
surgical procedure, or the particular patient. This same
construction could also be incorporated into other needle designs.
FIGS. 9 & 10 depict alternative structures for reinforcing that
part of the needle through which the eye is located, to avoid
inadvertent breakage of the needle as it is being used. In FIG. 9,
the needle 94 is a double pointed, curvilinear needle with a
centrally located eyelet 96. The reinforcement is provided by
providing a swaged sleeve 98 of material near the mid-point where
the eyelet 96 is drilled or otherwise formed into the needle 94.
Also, as shown in FIG. 9, a series of measured graduations 100 are
provided at each end 102 which indicate to the surgeon the position
of the needle 94 as it is partially inserted in the patient so that
inadvertent exiting of the needle 94 is avoided, and for more
precise placement of the suture during the procedure. In FIG. 10, a
curved, double pointed needle 104 has a thickened shaft 106, which
could also be a sleeve swaged into place, surrounding the eyelet
108 as positioned either at an end 110 or at a mid-point 112.
[0155] The needle embodiments of the present invention may also be
provided with one or more of a series of alternative design stops,
as depicted in FIG. 11-17. In FIG. 11, an end 114 of a needle 116
is depicted with an arrowhead shaped stop 118. The stop could be
either threaded onto the end 114 of the needle 116 so that its
position could be adjusted by the surgeon, or swaged into a fixed
position. The stop 118 could also be provided in different lengths.
A suture 120 may also be swaged into the stop 118. In FIG. 12, a
stop 118 shaped like a ball 122 may also be provided, again either
with Internal threads to permit adjustment by the surgeon or swaged
into a fixed position. In FIG. 13, a stop 118 comprises a fin 124,
one or more of which extends radially from the needle end 126. The
fins 124 may be provided as part of a sleeve 128 that could be
threaded onto the needle end 126, or swaged directly onto the
needle end 126. FIGS. 14 & 15 depict another stop 118 comprised
of one or more retractable barbs 130 which may be either threaded
onto the needle end 132 (FIG. 14) or swaged into fixed position
onto the needle end 132 (FIG. 15). The barbs are swivel mounted so
that a retainer 134 may be slid down the needle end 132 to hold
them in a retracted position for removal of the needled end 132 at
the completion of the surgical procedure. FIGS. 16 & 17 depict
other stops 118 comprised of an arrowhead shape, or fish hook, or
cone, or barb 136, with alternate locations of the eyelet 138 (FIG.
16) for attaching the suture. In essence, the stop designs shown
are exemplary, the function of the stop being to give the surgeon a
physical indication of the needle position during the course of the
surgery by mechanically restricting exiting of the needle end from
the patient.
[0156] A specially shaped needle 140 is depicted in FIG. 18,
especially intended for use in a RAFT surgical procedure. It
comprises essentially a "J" shape of a longer relatively straight
portion 142 transitioning into a more sharply curved portion 144
with pointed, cutting end 146. The curved portion is preferably a
beveled, cutting shape, such as a trilateral cross sectional shape
148, to facilitate its being driven into the deep tissues of the
patient's chest. The beveled cutting shape may extend further into
the straight portion, depending on the particular technique,
patient anatomy, or surgeon preference. A suture 150 may be either
passed through an eyelet 152 at the opposite end 154, or swaged
into fixed location thereat. Its use in a RAFT procedure is
explained in greater detail, below.
[0157] As depicted in FIG. 19, a bone anchor 156 may be screwed
into or otherwise attached to a patient's clavicle in a RAFT or
other breast augmentation/reconstruction procedure for gathering
the one or more sutures passing in and around the breast and
securing them after the reconstituted breast is desirably
positioned. The bone anchor may include a ring or washer 158 for
receiving the suture(s) 120 and which allows them to be
individually adjusted in length before being affixed.
[0158] FIG. 19 (a) depicts various alternative embodiments for the
bone anchor 156 including different arrangements for attaching the
suture 120. As shown therein, in a first embodiment the bone anchor
preferably comprises an orthopedic, Phillips head screw 300 which
is preferably countersunk into the clavicle so as to be flush with
the surface of the clavicle. A preferably thin, flexible but
resilient washer 302 is preferably attached to the screw 300, in
one of several optional ways. This washer may be a double washer
304 having a first annulus 306 through which the screw 300 is
Inserted as it is attached to the clavicle and a second annulus 308
through which the suture(s) may be threaded and then tightened
during the surgery. The double washer 304 may be made from any
suitable medical grade material for permanent implantation into the
patient's body. As an alternative, a washer 310 may be secured to
the screw 300, such as with a suture 312 swaged onto the screw 300
so that as the screw 300 is secured the suture 312 remains exposed
to support the washer 310 and is not crimped or otherwise has its
integrity affected through tightening of the screw 300. In yet
another embodiment, the head 314 of the screw 310 may have an
annular flange 316 which may engage the annulus 306 to squeeze it
between the flange 316 and the surface of the clavicle, thereby
providing what is believed to be a more secure positioning of the
washer 304 and its annuluses 306, 308 relative to the clavicle.
With either of these embodiments, the washer 310 or second annulus
308 may be crimped to capture the suture 120 after it is passed
therethrough and fix the suture in place, as desired. Another
feature of the bone anchor 156 may be to include a set screw or cam
318 within the second annulus 308 which may be tightened to
internally clamp or capture the suture(s) 120 within the second
annulus 308. With the set screw or cam 318 feature, the suture(s)
120 may be readily adjusted during, and even after the surgery to
achieve the desired patient results. The needle (for example needle
140 as used in the RAFT procedure) may have a suture 120 swaged to
an end thereof and a bone anchor 156, such as one of the washers
302, 304, swaged to the other end of the suture 120 to thereby
provide a convenient assembly or surgical tool 320 for a surgeon to
perform the RAFT procedure or other surgical procedure, thereby
saving the time and trouble of the surgeon attaching these elements
together during surgery.
[0159] FIG. 20 depicts a tissue dissector 160 and tissue rasp 162.
The tissue dissector 160 comprises a relatively long, thin rod 164,
solid or hollow, characterized by a series of points or ridges or
cones 166. Alternatively, a more aggressive dissector 160 could
include shark fin like winglets 168 or other more aggressive
cutting structures. The rod 164 could be spatulated or round, and
would preferably have a rounded, non-cutting tip 170. The tissue
dissector preferably has an active end 172 and a passive or
non-acting central portion 174 and a thickness of between about 1
mm to about 3.5 mm. The tissue rasp 162 has a thin preferably metal
rod or hollow cannula 176 with a series of rasp-like grooves 178
oriented in various directions, as desired to achieve what may be
generally considered as a more aggressive surface than a tissue
dissector's active end 172. The grooves 178 could be oblique,
orthogonal, or otherwise, and of different and varying depths to
achieve the desired degree of aggressiveness. The tissue rasp 162
has an active portion 180 containing the grooves 178 and an
inactive portion 182. As explained above, these are similar
surgical tools but generally the rasp is intended to provide a more
aggressive abrading surface, while the tissue dissector is intended
to provide more of a cutting or nicking effect on taut connecting
tissues.
[0160] FIG. 20(a) depicts the working or active ends 172, 180 of
representative tissue dissectors 160 and tissue rasps 162. For
example, in one view depicted in FIG. 20 (a) a tissue dissector 160
has a series of shark fin like winglets 168 arranged with their
cutting edges in opposite directions to provide a cutting action in
both directions as the surgeon moves the tissue dissector in and
out and along a tissue plane. These shark fins 168 are also shown
oriented at 90r about the circumference of the spatulated, active
end 172. A tissue rasp 162 is depicted having a generally
cylindrical shape, with circular cross section, and having a series
of teeth 179 extending generally radially from its surface. These
teeth can be formed in a myriad of shapes and sizes, with sharp or
blunt ends, with hooks or not, or otherwise to obtain the desired
results during use. A second rasp 162 is also shown, similar to
that depicted in FIG. 20, to again illustrate the myriad of groove
shapes, depths, and arrangements that can be provided to achieve
the desired aggressiveness depending on its intended use.
[0161] The tissue mesher 190 is shown in its various embodiments in
FIG. 21-28. As shown in FIG. 21, three rectangular blocks 192 may
be secured together with a pair of threaded rods and wing nut
fasteners 194. A matrix of cylindrical holes 196, shown in a
2.times.4 pattern in FIG. 21, are formed between the blocks and
each of which receives and clamps e.g. a hypodermic needle 198 with
a sharp, cutting edge point 200. The needles could alternatively be
sharpened rods, or other similar cutting pointed instruments,
either hollow or solid. This embodiment of the tissue mesher 190
allows the cutting points to be positioned at different depths
which provide for creating a three dimensional or two dimensional
tissue block, as explained, supra. As shown in FIG. 22, the tissue
mesher 190 may be provided with different matrices in essentially
the same multi-block, fastened structure. As depicted, a six block
192 matrix of nineteen holes 196 may be readily formed for clamping
cutting points at varying, or the same, depth. In order to provide
for controlled lateral translation of the cutting points, as
depicted in FIG. 23 a tissue mesher 190 similar to those already
described may be slidably mounted to a pair of cross rails 202
secured at their ends 204 with a pair of support rods 206. When
lateral movement is desired to make the incisions, the mesher 190
is first pressed against the dermis desired to be treated and then
slid along the rails 202. FIG. 24-26 depict variations of swivel or
articulated couplings 208 which may be similarly used to mount the
tissue mesher and provide for controlled movement of the sharp
cutting points (not shown) to create the desired incisions. FIG.
27-28 depict rack and pinion arrangements 210 also for achieving
controlled lateral translation of the tissue mesher.
[0162] Various of the foregoing inventions may be provided in a
surgical kit, for single use or as a reusable kit, for a surgeon to
purchase and perform one of the surgical procedures described
herein. The Inventor contemplates that as these inventions arc
commercialized various ones of these Instruments will be found to
be included in one or more kits, as well as which variations of the
individual instruments from amongst the alternative embodiments
described herein. Thus, the inventions are not considered as being
limited to the described embodiments but instead should be limited
solely by the metes and bounds of claims as they are drafted and
presented in a non-provisional application claiming priority to
this provisional application.
[0163] Use of a number of these inventions will now be explained in
the context of the RAFT breast augmentation/reconstruction
procedure, and by reference to FIG. 29(a)-(g); and FIG. 30-32.
A-- Design of the Arc of Abdominal Anterior Thoracic Tissue to be
Purse Stringed and Advanced:
[0164] Depending upon the abdominal tissue laxity and the amount of
tissue required for the reconstruction, up to a 12 cm wide arc of
upper abdominal/lower thoracic tissue can be mobilized and brought
up to form a breast or to augment a pre-existing one. The pattern
of the purse string arc determines the tissue that will be
advanced. This arc is outlined on the patient skin prior to the
surgery. See FIG. 29(a).
[0165] The arc that will be purse stringed and advanced
cephalically starts at the medial end of the inframammary fold (or
where the Inter-mammary fold starts), then continues caudally and
laterally up to a level just anterior to the mid auxiliary line to
extend back up cephalically at the level of the lateral end of the
Inframammary fold, or what is more correctly referred to as the end
of the lateral mammary fold. The thread loop will be passed from
the clavicle in a deep plane over the bony sternum up to the
beginning of the arc. Along the course of the arc, the suture is
kept subcutaneous or intra-dermal. Keeping an even level of needle
passage is considered important by the inventor in order to avoid
accordion curtain like irregular folds as the purse string is
tightened. At the lateral end of the arc, the suture dives deep
again into the subcutaneous tissue and is advanced medially and
cephalically to close the loop up at the starting point at the
level of the clavicle.
B-- Passing the Looped Thread:
[0166] The passing of the suspension suture is the cornerstone of
this procedure. This is where the "J" shaped needle invention
disclosed herein is put to good use. It preferably is long enough
to reach from the clavicle to the upper abdomen with enough shaft
length left to handle and guide it. The curvature is like a double
"J" and it is preferably rigid to be driven for such a long
distance while malleable enough to be steered through the tunnel it
slices longitudinally through the dermis with its sharp cutting
edges. Maintaining an even depth of the needle as it courses
through the preferred immediate subdermal plane is preferable. To
that effect, special design of the cutting tissue dissecting tip
might be required such as fins or ailerons. When the sutured is
pulled, passages that are too superficial will lead to dimpling or
puckering of the skin and passages that are too deep will lead to
ridging. Since the desired result is an even line fold, it is
preferred to stay in the same plane throughout the suspension arc.
Alternatively, more than one suture may be passed such that any
ridges left by deeper passes of the first suture are captured and
brought down to create an even fold.
[0167] After making a small slit on the anterior chest wall just
under the clavicle, (the level of the clavicular bone anchor) two
strong needle holders are required to stepwise advance the needle.
See FIG. 29(a). Though two strong, pliers like, needle drivers are
currently used, the inventor conceives of a handling device that
can effectively grab the needle and drive it down along its long
downward spiral passage as it follows the spiral down contour of
the sternum to emerge subcutaneously at the level of the breast.
The needle tip is first allowed to exit at a point along the
previously marked arc, just below the intermammary fold level. See
FIG. 29(b). If this hole has been "matured" by liposuction (see
below the dissecting of the abdominal apron section), then the
needle used does not need to be double pointed. (A long needle such
as this one is easier and safer to handle if it is not pointed on
both ends.) Holes that have been "matured" by previous repeated
cannula passage have loose and destroyed subdermal fibers such that
an in and out passage of the needle through the same hole has
little chance of catching intact fibers and therefore will not
dimple down the skin when tightened.
[0168] The needle is then passed in the deep dermal/subcutaneous
tissue along the pre-marked arc, coming in and out as necessary
through the previous liposuction puncture holes till the end of the
mammary fold, in the lateral chest at about the mid-axillary line
and the third to fourth Intercostal space. See FIG. 29(c)-(f). This
last puncture wound is the position of the end of the lateral
mammary fold and from there on, the course of the needle comes
deep, it could pierce the pectoralis or course along the anterior
axillary fold to emerge anteriorly through the original
subclavicular incision and complete the loop. See FIG. 29(g).
[0169] Pulling cephalically on this suspension loop advances the
upper abdominal tissue to the breast area and the purse string
effect mushrooms it into a breast dome. See FIG. 30-32. The
inferio-lateral portion of the thread in the subcutaneous tissues
defines the inframammary and lateral breast folds. Anchoring the
loop to the clavicle and tightening it advances the abdominal and
lateral thoracic flaps to create a breast mound with new
inframammary and lateral breast folds. See FIG. 29(g).
[0170] Inserting an implant is one of the alternatives to provide
volume. However, lipofilling the mobilized tissue is often the
preferred alternative, using one of my patented techniques and
devices. Oftentimes these are combined.
C-- Dissecting the Abdominal Apron and Mobilizing it:
[0171] This Is actually the first step of the procedure. It
consists of tumescent liposuction of the abdominal apron through
3-8 14G needle puncture wounds along the previously marked upper
abdominal arc with the most lateral puncture at the mid-axillary
line, 3.sup.rd to 4.sup.th intercostal space (where the lateral
mammary fold would naturally end). We make a few additional
puncture wounds for liposuction cannula entry around the mid
abdomen, the umbilicus and the lower abdomen. The criss-crossing of
the cannula tunnels loosen the abdominal wall fibers to a certain
extent. Then, through these same puncture wounds, using a special
dissecting cannula (as described above), we mobilize the abdominal
apron and the postero-lateral thoracic flap.
D-- Re-Orienting the Fibers, Deepening the Fold and Relieving the
Abdominal Tightness:
[0172] To further define the fold and create the natural overhang
of a pendulous breast, the fibers that prevent the bulging and
mushrooming of the tissue on the inner side of the purse string
loop need to be divided. As described before, these fibers have to
be divided in a staggered fashion with different fibers cut at
different levels to generate an inter digitating expansion. Tissue
meshers help re-orient the fascia fibers, relieve tension and
eliminate unwanted folds. Dividing the stretched nerves is also
achieved. Because pulling or stretching or strangulating sensory
nerves causes severe pain, it is also Important to avoid grabbing
cutaneous sensory nerves in the loop. On the other hand simply
dividing the nerves as is done during most operative procedures
might lead to some decreased sensation of the territory of the
nerve but usually causes no pain. The staggered meshing therefore
also serves to cut the nerves and avoid the nerve pain.
E-- Tightening the Skin where Needed:
[0173] Tightening of the skin may be achieved with the tissue file
and rasp described herein with the post dissection redraping,
scarring and contraction maintained with the help of an external
adhesive supportive splint and/or internal sutures.
F: Post Op Care Wearing the External Moldable Splint
[0174] To complete the treatment, an external splint is applied,
which can be formed with transparent surgical tape, an elastic mesh
tape or a supportive brassiere otherwise constructed specially for
this purpose, to hold the reconstructed breast in position and
shape. After a few weeks, the splint may be removed and the patient
has achieved the desired result.
[0175] As shown in FIG. 33 (a)-(c), the tissue dissectors and rasps
disclosed herein may be themselves used, along with the transparent
or inconspicuous easy to conceal and wear resistant bra, to perform
a breast lift without surgical Incisions typified by prior art
procedures. For example, a woman suffering from ptosis of the
breast, as depicted in FIG. 33 (a), as is well known, has a sagging
breast with the breast 400 being comprised of glandular tissue 402
surrounded by fat 404 all of which is connected. In this procedure,
the breast 400 is first inflated with a suitable fluid such as fat
and epinephrine containing physiologic solution to become tumescent
which tightens the connecting tissue, and then tissue dissectors
160 are used to cut the connecting tissue between the fat 404 and
the glandular tissue 402 to create a space 406, as depicted in FIG.
33 (b). Several small dissector entry openings 408 are created in
unobtrusive locations to be able to extend the tissue dissector 160
around the glandular tissue 402 and reach and cut most if not all
of the connecting tissue. After separation, a tissue rasp (not
shown) is inserted through these same openings 408 and the
glandular tissue is abraded or irritated/inflamed to incite the
desired scarring. Then the breast is lifted into its desired final
position and shape, either manually or by use of a small suture to
support the breast or with the patient laying on her back, and a
preferably transparent bra 410 is applied preferably during this
breast moving/shaping process which, when the breast reaches its
final position preferably becomes adhesive to the breast and also
above the breast and perhaps as high as the clavicle, or around the
shoulder as bra straps to hold it in its desired final position and
shape. The supportive bra can come in pre-determined shapes with a
protective sheet for the adhesive layer or can be applied as
multiple pieces or strands that overlap and interdigitate to reach
the desired shape and support. The breast 400 is then held in
position, as depicted in FIG. 33 (c), for a somewhat extended time
period, perhaps a few or even up to six weeks, while the tissue
scarring forms in sufficient rigidity to hold the breast in place
without the bra. After achieving the formation of the supporting
scar tissue, the bra 410 may be removed (might use the help of an
adhesive remover) and the patient is finished with the process
having achieved a successful breast lift. The inventor contemplates
that this bra 410 is preferably transparent so that the underlying
skin tissues may be examined to ensure no complications.
Alternatively could be skin colored for better concealment. Also,
the bra may be made of a sheet or mesh fiber, or elastic weave,
that would be pliable upon application and then could be fixed, for
example such as by adding a rigidifying layer or spraying a
fixative thereon, to hold it in place. The bra could be made of
thin cotton or silk fabric that would cure, could be pre-formed or
cut into shape during or before surgery to suit the particular
patient's physique. Although depicted and explained as a breast
lift, this same method is envisioned by the inventor as being
suitable for other tissue engineering applications such as body
lifts, tummy tucks or face lifts, for example.
[0176] As shown in FIG. 34, a shuttle needle 520 is inserted
through a grommet 522 inserted into a hole 524 in a bra 526 created
by the needle 520 as it is passed through the bra 526 at points 527
marked along the bra 526 in a pattern, and with the bra 526
preferably adhered but at least close fitting to a breast 528. The
shuttle needle 520 is used to form the basket weave (see below)
within the breast 528, as explained in greater detail below. The
shuttle needle 520 generally is formed in a curve with two ends 530
and a centrally located eye 532 through which one or more threads
534 are passed for weaving a supporting basket weave inside the
breast 528. Although the Inventor discloses a shuttle needle 520 as
his preferred embodiment, other needles may be used so long as care
is taken to loop the thread 534 and form the basket weave.
Furthermore, the needles disclosed and described above may also be
used, keeping in mind the teaching of this specification. FIG. 35
depicts an alternate design for a grommet 522 and which includes a
shoulder 536 to better hold the grommet 528 in place in the bra 526
and prevent the needle 520 or tensioning of the thread 534 by
continued weaving from inadvertently and prematurely pulling the
thread 534 back inside the breast 528. FIG. 36 depicts the basket
weave 538 which is formed inside the breast through use of the kit
540 of the invention, as explained below. Although the inventor
prefers the interlocking basket weave construction depicted in FIG.
36, in would be understood by those of skill in the art that other
patterns could be used to like effect and even specialized weaves
to address and correct particular construction issues in a patient.
FIG. 37 depicts the basket weave 538 inside the breast 528 to give
a better idea of the relative size, location and spacing of the
inventor's preferred basket weave 538. FIG. 38 depicts the shuttle
needle 520 with its two ends 530 and centrally located eye 532.
Also depicted are two sets of graduations 542 which are used by a
surgeon as a guide and indicator as to the relative position of the
needle inside the breast as the basket weave 538 is created. FIGS.
39 and 40 depict the shuttle needle 520 passing through the breast
parenchyma as desired to anchor the basket weave 538, as explained
below.
[0177] The kit described above is preferably used to surgically
construct subcutaneously the "internal brassiere" as next
described.
Technique for Use of the Kit
1-- Preparation of the Breast:
[0178] The procedure preferably starts with tumescent diffuse
injection of the subcutaneous tissue with dilute lipoaspirate
containing adrenaline. The fluid in the injected dilute fat graft
distends the subcutaneous plane making it easier to dissect while
the fat grafts provide fill and glue & are a source of
regenerative factors. While the procedure can be performed without
fat injection, only with tumescent fluid containing adrenaline, the
inventor prefers to add fat grafts or other regenerative reagents
such as allograft preparations as most women also desire some
additional volume augmentation. Furthermore, the inventor is aware
of the regenerative properties of fat grafts and their ability to
help correct contour defects.
[0179] Subcutaneous dissection of the skin away from the breast
parenchyma allows the crucial re-draping of the skin over the
breast parenchyma as the mastopexy will ultimately hold thanks to
this re-draping and to the healing interface created by the
dissection. This dissection is preferably done with a special
cannula through a number of circum-mammary and circum-areolar
needle puncture sites. This subdermal abrasion performed in this
stage also in itself causes deep scarring and retraction of the
stretched out skin.
[0180] Kit Components Used: A standard liposuction--dissecting
injection cannula may be provided as part of the kit, but may also
be readily available to most plastic and reconstructive surgeons
and thus not provided as part of the kit.
2-- Placement of Bra:
[0181] With the patient sitting as upright as possible on the
operative table, nice fitting brassiere is preferably applied that
restores the desired shape and position of the nipple areola
complex. Once the ideal breast shape is reached, the breast is
preferably suspended to the shoulders and the bra is preferably
made to harden and stick to the skin such as by applying a
hardening/gluing biocompatible material.
[0182] Kit Components Used: A sterile mesh fabric or initially
stretchable material that can be formed into a nice fitting and
supportive brassiere. A glue-like biocompatible compound that is
preferably incorporated in the fabric, and which sticks &
hardens. A bra that preferably stays semi-transparent with
rubbery/plastic consistency with a pattern of thread weave
preferably marked on the bra.
3-- Weaving the Threads:
[0183] Through a small, approximately 0.5 cm incision at the
clavicle, a bone anchor is inserted and through that same incision
is passed the shuttle needles and threads. The needle preferably
follows the weaving pattern outlined on the bra and a
grommet/sleeve is preferably inserted at each needle exit/entry
site. A small loop of thread is left outside (with a separate
thread or small pin to prevent retraction of that loop as the
thread continues to be weaved).
[0184] The depth of the sleeve/grommet is preferably adjusted to
ensure that the thread weaves a brassiere mesh in the deeper
tissues and does not grab the dermis and subdermal tissue.
[0185] The grommet/sleeve device has been found to permit the
weaving of the internal bra. They insure that dermal fibers are not
inadvertently caught as the needle comes in and out. The thread
loops left outside allow the interlacing of the separate threads to
create a weave that is then pulled deep inside as the threads are
brought snugly together and the grommets are removed.
[0186] A total of 6-12 threads are preferably used depending upon
the size of the breast, the degree of ptosis and the consistency of
the breast (fatty loose breasts require more loops than the more
parenchymal denser firmer breasts).
[0187] Kit Components Used: A long sharp curved needle (preferably
shuttle type) which may be passed with a heavy needle holder.
Grommets/needle sleeves, that stick out of the hardened conforming
adherent bra to ensure that the weave is kept in the deeper tissues
and that it is the deeper tissues that are suspended. Threads
(preferable to have each thread color coded to follow its weave
pattern and to couple them together at the time of tying). Threads
non-resorbable (preferably use #1 Prolene). However a
fascia/collagen based allograft or synthetic material that could
regenerate tendon might also be preferable depending on the surgeon
and the patient.
4-- Completing the Suspension.
[0188] The threads are pulled with the same even gentle tension on
all threads. It is considered important not to tighten too much but
rather to just pull them snug to where there is no laxity in the
thread. The thread should hold the position given to it by the
bra.
[0189] The rigid adherent bra is considered important as it
preserves and ensures the proper shape and prevents indents and
unevenness in the breast. The contour of the breast has been found
to be uneven if the loops do not have the proper length.
[0190] The inventor has found that the variable that perhaps is the
most important is the length of the individual thread loops. This
is determined by tying the knot or crimpling together the two ends
of the thread. The supporting bra is the device that adjusts this
variable. It Insures that virtually the exact loop length Is
reached when the two ends are just snug while supported by the bra
and not too tight so that the skin dimples inside the bra. This is
the rationale behind having the bra device become rigid and
adherent to the skin.
[0191] The transparent/translucent property of the bra allows
inspection to ensure that the skin has not separated/unstuck itself
from the bra if a loop is tied too tightly. Without this static
support it would probably be difficult to get the exact tension on
each one of the individual thread loops as they are tied/crimpled
together. The Bra further ensures that the support is not dependent
on the sutures--no dimples--no dermis or subdermis caught in the
sutures and that we achieve an even suspension of the deeper
tissues, allowing the dissected off skin to passively redrape.
[0192] A preferred alternative to tying the individual thread is a
device that can crimple/lock them all together in one step. This
also avoids having many sutures bulked together under the
clavicle.
[0193] Kit Components Used: Crimpling/locking tool/device that
connects all the threads together to the clavicle anchor.
5-- Final Stage/Post Op Dressing:
[0194] Remove the adherent Bra and grommets. Simply close the small
clavicle incision and inject some fat around the crimple site to
camouflage the thread.
[0195] Apply a tagaderm type adherent dressing that supports the
breast and immobilizes it for a few days to a couple of weeks till
the repositioned skin heals in the desired position.
Other Additional Features:
[0196] 1-- Array of needle tips inserted through non-scar inducing
tiny punctures selectively divide the vertical fibers that are
under tensed by the forced advancement of the superficial tissue
layers. The cuts are discrete and are at different levels such as
to open no tissue plane and leave no cavities as the tissue
advances. [0197] 2-- Belt like locking device consisting of two or
more holes on a small band. The device is connected to the bone
anchor. The holes might have winglets for added directional
grabbing ability. The threads having completed the purse-string
loop are inserted through the holes through a simple passage or a
back and forth loop such that the tension can be adjusted and the
sutures locked into place. Additionally, the device can be crimpled
tight for a more secure hold; 1-- outer cortex of the bone; 2--
bone anchor inserted in the bone; 3--connector between anchor and
locking device; 4-- belt-like ring locking device that can also be
crimpled for better locking strength; 5-- threads having completed
the purse-string suspension loop. See for example the embodiment
depicted and as described above in FIG. 44. [0198] 3-- Belt like
locking device consisting of two or rings. The device is connected
to the bone anchor. The threads having completed the purse-string
loop are inserted through the loops with back and forth loops such
that the tension can be adjusted and the sutures locked into place.
Additionally, the device can be crimpled tight for a more secure
hold; 1-- outer cortex of the bone; 2-- bone anchor inserted in the
bone; 3-- connector between anchor and locking device; 4-- washer
slit winglets to directionally grab suture; 5-- belt-like locking
device that can also be crimpled for better locking strength; 6--
threads having completed the purse-string suspension loop. See for
example the embodiment depicted and as described above in FIG. 43.
[0199] 4-- Alternative design of the "J" needle used for the RAFT
procedure. The cutting sharp end of the needle has triangular or as
shown has quadrangular winglets that facilitate maintaining the
same plane of penetration along the tissue. The sharp pointed tip
rapidly assumes a cross like configuration in cross section to
eventually resume the rounded cross section of the needle shaft at
the end of the long bevel. Inserts show the cross section at
multiple levels. See for example the embodiment depicted and as
described above in FIG. 45. [0200] 5-- Design of needle with an eye
that allows it to grab a suture loop or segment. A-key chain like
spiral loop where the thread loop can be fed to end up locked
inside the needle. 1 thread entrance site. B--slit gap that can be
spring loaded to insert the suture loop into the eye of the needle.
2--thread entrance site. See for example the embodiment depicted
and as described above in FIG. 42.
[0201] The principal advantages and features of the several related
inventions have been disclosed and described illustratively in the
preferred embodiments. However, as would be understood by those of
skill in the art, the inventions are not limited to these
illustrative embodiments and instead the inventor intends that the
scope of his inventions be limited solely to the scope of the
claims appended hereto, and their legal equivalents.
* * * * *