U.S. patent application number 11/829539 was filed with the patent office on 2008-04-10 for minimally-invasive mastoplasty procedure and apparatus.
This patent application is currently assigned to ANGIOTECH PHARMACEUTICALS, INC.. Invention is credited to Richard G. Jones, Benjamin Schlechter.
Application Number | 20080086169 11/829539 |
Document ID | / |
Family ID | 38722825 |
Filed Date | 2008-04-10 |
United States Patent
Application |
20080086169 |
Kind Code |
A1 |
Jones; Richard G. ; et
al. |
April 10, 2008 |
MINIMALLY-INVASIVE MASTOPLASTY PROCEDURE AND APPARATUS
Abstract
Medical devices and methods are provided for a
minimally-invasive mastoplasty procedure. In the procedure, barbed
sutures are used to accomplish the mastoplasty through puncture
wounds by deploying the sutures caudally from stable anatomical
features into the breast tissue.
Inventors: |
Jones; Richard G.; (West
Chester, PA) ; Schlechter; Benjamin; (Wyomissing,
PA) |
Correspondence
Address: |
FLIESLER MEYER LLP
650 CALIFORNIA STREET
14TH FLOOR
SAN FRANCISCO
CA
94108
US
|
Assignee: |
ANGIOTECH PHARMACEUTICALS,
INC.
VANCOUVER
CA
|
Family ID: |
38722825 |
Appl. No.: |
11/829539 |
Filed: |
July 27, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60833999 |
Jul 28, 2006 |
|
|
|
Current U.S.
Class: |
606/228 |
Current CPC
Class: |
A61B 2017/00796
20130101; A61B 2017/06176 20130101; A61B 2017/06028 20130101; A61B
17/06166 20130101; A61B 2017/06057 20130101; A61B 2017/0496
20130101; A61B 2017/00792 20130101; A61F 2/0063 20130101; A61F 2/12
20130101; A61B 17/0469 20130101 |
Class at
Publication: |
606/228 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A method of performing a procedure to reposition portions of a
breast having a nipple-areola complex (NAC) using a suture
including a plurality of barbs, the barbs, on a first portion of
the suture between a first end of the suture and a first axial
location on the suture for permitting movement of the suture
through tissue in a direction of movement of the first end and
preventing movement of the suture through tissue in a direction
opposite the direction of movement of the first end, and the barbs
on a second portion of the suture between a second end of the
suture and a second axial location on the suture permitting
movement of the suture through tissue in a direction of movement of
the second end and preventing movement of the suture through tissue
in a direction opposite the direction of movement of the second
end, the method comprising the steps of: (a) inserting the first
end of the suture through the skin of a patient at a first fixation
point located cranially of the inframammary fold; (b) causing the
suture to engage a stable anatomical feature accessible from the
fixation point; (c) deploying the first portion of the suture
through breast tissue along a first deployment path to a first exit
point located caudally of the fixation point and medially of the
NAC; (d) inserting the first end of the suture through the skin of
the patient at the first exit point; (e) deploying the first
portion of the suture through breast tissue along a second
deployment path to a second exit point located laterally of the
NAC; (f) inserting the second end of the subject through the skin
of a patient at the first fixation point; (g) deploying the second
portion of the suture through breast tissue along a third
deployment path to a third exit point located caudally of the
fixation point; (h) advancing the breast tissue caudally and
medially relative to the first portion of the suture.
2. The method of claim 1, wherein step (a) comprises inserting the
first end of the suture through the skin of a patent at a first
fixation point located cranially of the inframammary fold and close
to one of a rib and a clavicle.
3. The method of claim 2, wherein step (b) comprises causing the
suture to engage a fascia pectoralis accessible from the first
fixation point.
4. The method of claim 1, wherein step (a) comprises inserting the
first end of the suture through the skin of a patient at a first
fixation point located cranially of the inframammary fold and close
to a second rib.
5. The method of claim 1, wherein step (g) comprises deploying the
second portion of the suture to a third exit point located caudally
of the fixation point and cranially of the NAC.
6. The method of claim 1, wherein step (g) comprises deploying the
second portion of the suture to a third exit point located caudally
of the fixation point and caudally of the NAC.
7. The method of claim 6, wherein: step (c) comprises deploying the
first portion of the suture along a first deployment path located
medially of the NAC; and step (g) comprises deploying the second
portion of the suture through breast tissue along a third
deployment path located laterally of the NAC.
8. The method of claim 1, wherein step (g) comprises deploying, the
second portion of the suture through breast tissue along a third
deployment path to a third exit point located caudally and
laterally of the NAC; and (g2) inserting the second end of the
suture through the skin of the patient at the third exit point; and
(g3) deploying the second portion of the suture through breast
tissue along a fourth deployment path to a fourth exit point
located medially of the NAC.
9. The method of claim 1, wherein step (f) further comprises: (f1)
deploying the second portion of the suture through tissue along an
intermediate deployment path and out through an intermediate exit
point located cranially of the inframammary fold; and (f2)
reinserting the second end of the suture through the skin of a
patient at the intermediate exit point.
10. The method of claim 1, wherein: step (c) comprises deploying
the first portion of the suture through shallow subcutaneous tissue
so as to allow elevation of the NAC towards the first fixation
point; and step (e) comprises deploying the first portion of the
suture through shallow subcutaneous tissue so as to allow
repositioning of the NAC medially.
11. The method of claim 1, wherein: step (c) comprises deploying
the first portion of the suture through deep parenchymal tissue so
as to allow elevation of the breast and NAC towards the first
fixation point; and step (e) comprises deploying the first portion
of the suture through deep parenchymal tissue so as to allow
contouring of the breast.
12. A suture implanted in tissues of a breast to maintain the
tissues of the breast having a nipple-areola complex (NAC) in an
elevated position wherein the suture comprises a first end, a
second end, an intermediate portion, and a first barbed portion
between the first end and the intermediate portion and a second
barbed portion between the second end and the intermediate portion
and wherein: the intermediate, portion of the suture is engaged
with a stable anatomical feature located cranially of the
inframammary fold; the first barbed portion of the suture is
engaged with tissues of the breast located along a line extending
first caudally through tissues of the breast medial of the NAC from
the stable anatomical feature and then curving laterally through
tissues of the breast located caudally of the NAC, the barbs on the
first portion of the suture preventing the tissues of the breast
from moving caudally relative to the stable anatomical feature; and
the second barbed portion of the suture is engaged with tissues of
the breast located along a line extending caudally through tissues
of the breast from the stable anatomical feature, the barbs of the
second portion of the suture preventing the tissues of the breast
from moving caudally relative to the stable anatomical feature.
13. The suture of claim 12, wherein the intermediate portion of the
suture is engaged with the fascia pectoralis.
14. The suture of claim 13 wherein the first barbed, portion of the
suture is engaged with tissues of the breast located along a line
extending caudally through tissues of the breast located medially
of the NAC.
15. The suture of claim 11 herein the second barbed portion of the
suture is engaged with tissues of the breast located along a line
extending caudally through tissues of the breast located laterally
of the NAC.
16. The suture of claim 12, wherein the intermediate portion of the
suture is engaged with the fascia pectoralis in the region of one
of the first rib, the second rib and the clavicle.
17. The suture of claim 12, wherein: the first barbed portion of
the suture is engaged with shallow subcutaneous tissues to
reposition a surface feature of the breast.
18. The suture of claim 12, wherein the first barbed portion of the
suture is engaged with deep parenchymal tissues of the breast so to
position the breast.
19. The suture of claim 12, wherein the second barbed portion of
the suture is engaged with tissues of the breast located along a
line that first extends caudally and laterally of the NAP and then
curves medically tinder the NAC.
20. A method of performing a procedure to reposition portions of a
breast having a nipple-areola complex (NAC) using a suture
including a plurality of barbs, the barbs on a first portion of the
suture between a first end of the suture and a first axial location
on the suture for permitting movement of the suture through tissue
in a direction of movement of the first end and preventing movement
of the suture through tissue in a direction opposite the direction
of movement of the first end, and the barbs on a second portion of
the suture between a second end of the suture and a second axial
location on the suture permitting movement of the suture through
tissue in a direction of movement of the second end and preventing
movement of the suture through tissue in a direction opposite the
direction of movement of the second end, the method comprising the
steps of: (a) deploying the first portion of the suture caudally
through breast tissue from a first fixation point located cranially
of the inframammary fold along a first deployment path passing
medially of the NAC and then curving laterally under the NAC to a
first exit point located on the breast located laterally and
caudally of the NAC; (b) deploying the second portion of the suture
caudally through breast tissue along a second deployment path from
a second fixation point located cranially of the inframammary fold
to a second exit point located on the breast caudally of the second
fixation point; and (c) advancing the breast tissue cranially
relative to the first portion of the suture to reposition the
breast tissue towards the first and second fixation points.
21. The method of claim 20, further comprising engaging the suture
with a stable anatomical feature adjacent the first fixation
point.
22. The method of claim 20, further comprising engaging the suture
with a fascia pectoralis adjacent the first fixation point.
23. The method of claim 22, wherein step (a) comprises deploying
the first portion of the suture from a first fixation point located
close to one of a first rib, a second rib and a clavicle.
24. The method of claim 20 wherein step (a) comprises deploying the
first portion of the suture through shallow subcutaneous breast
tissue so as to allow elevation of the NAC towards the first
fixation point.
25. The method of claim 20 wherein step (a) comprises deploying the
first portion of the suture through deep parenchymal breast tissue
so as to allow elevation of the breast and NAC towards the first
fixation point.
26. The method of claim 20, wherein step (b) comprises deploying
the second portion of the suture from a second fixation point
located in the same place as the first fixation point.
27. The method of claim 12, wherein step (b) comprises deploying
the second portion of the suture laterally through breast tissue
from the first fixation point to the second fixation point prior to
deploying the second portion of the suture caudally through breast
tissue along a second deployment path from the second fixation
point to a second exit point located on the breast caudally of the
second fixation point.
Description
CLAIM OF PRIORITY
[0001] This application claims priority to U.S. Provisional
Application No. 60/833,999 entitled "Minimally-Invasive Mastoplasty
Procedure" filed Jul. 28, 2006 and [Attorney Docket No.
ANGIO-01006US0] which is hereby incorporated by reference.
BACKGROUND OF INVENTION
[0002] This invention relates to minimally-invasive methods and
medical devices for performing cosmetic breast surgery or
mastoplasty. More, specifically, the invention provides methods and
devices for performing breast and nipple-lifts and contouring the
surface of the breast without the need for open surgery.
[0003] A breast-lift (mastopexy) is usually performed for drooping
breasts (mastoptosis), which may occur with age, after weight-loss
or after a woman has had children. The skin loses its elasticity
and the breasts lose their firmness and shape as they sag under the
effects of gravity. The degree of droop or ptosis is measured by
how far the nipple has fallen below the inframammary fold.
Mastoptosis requiring mastopexy is present when the nipple has
fallen below the plane of the projected inframammary fold. However,
cosmetic breast surgery or mastoplasty may be performed for
aesthetic reasons regardless of the extent of ptosis present.
[0004] Surgical mastopexy is the standard treatment for
mastoptosis. In 2004 more than 98,000 mastopexy procedures were
performed in the United States. Breast-revision surgery such as
mastopexy is an invasive open surgery procedure. The procedure is
performed under general anesthesia, either in an outpatient
facility or in the hospital. Most patients require a two-day
hospital stay. During the procedure, incisions are made along the
natural creases in the breast and around the dark pink skin
surrounding the nipple (areolus). A keyhole-shaped incision above
the areolus is made to define the new location of the nipple. Skin
is then removed from the lower section of the breast. The areolus,
nipple (nipple-areola complex or NAC), and underlying breast tissue
are moved up to a higher position. The breasts are lifted using
suspension sutures in the deep parenchymal tissue and tucks in the
redundant skin. The NAC is moved up into the keyhole incision and
all the incisions are closed with sutures. Large incisions are
required, and in order to elevate the NAC, periareola incisions are
always required. The sutures remain for two weeks after surgery and
are then removed. It is a disadvantage of the mastopexy procedure
that it requires long incisions, and, although care is taken to
reduce scarring, some scarring is usually evident. A further
disadvantage is that the long incisions and exposed tissues create
a risk of post-operative infection.
[0005] After surgery, a bulky gauze dressing is wrapped around the
breasts and chest. Sometimes a surgical bra is used. The patient is
usually in significant pain, which necessitates control by
medication for the first few days. Generally, the swelling and
discoloration around the incisions take a few days to subside. The
surgical dressing must be worn for up to a week at which point it
is replaced with a surgical bra, which must be worn for several
weeks.
[0006] Thus, the open mastopexy procedure requires a lengthy
hospital stay and an even longer convalescence period in which the
patient may not be able to work. Patients may not return to even
low impact exercise until three weeks following surgery and to
higher impact activities such as jogging, until six weeks following
surgery. The patient may suffer discomfort in this period after the
procedure, requiring further medication. Possible side effect of
the procedure, include scarring and temporary loss of sensation in
the breast skin and nipples.
[0007] It would therefore be desirable to provide a breast-lift
and/or NAC-lift procedure, which does not require long incisions
and can be performed with a minimally-invasive procedure.
[0008] It would also be desirable to provide a breast-lift and/or
NAC-lift procedure, which reduces the pain, and discomfort suffered
by the patient and reduces the recovery time of the patient.
[0009] It would further be desirable to provide a breast-lift
and/or NAC-lift procedure, which reduces the risk of scarring and
scar tissue formation.
[0010] It would still further be desirable to provide a breast-lift
and/or NAC-lift procedure with reduced incidence of side effects
such as temporary loss of sensation and infection.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Features of the invention, its nature and various advantages
will be apparent from the accompanying drawings and the following
detailed description of various embodiments, in which:
[0012] FIG. 1 shows a suture for performing procedures of an
embodiment of the present invention;
[0013] FIGS. 2A-2C show detail views of the suture of FIG. 1;
[0014] FIG. 3 shows anatomical features and markings that may be
made during planning for a breast-lift and/or NAC-lift
procedure;
[0015] FIGS. 4A-D show the steps of a method for a breast-lift
and/or NAC-lift procedure according to one embodiment of the
present invention;
[0016] FIG. 5A-L show alternative deployments for breast-lift
and/or NAC-lift procedures in accordance with different embodiments
of the present invention;
[0017] FIGS. 6A-D show the steps of a method for a NAC-lift
procedure according to one embodiment of the invention; and
[0018] FIGS. 7A-D show the steps for a combination breast-lift and
NAC-lift procedure according to one embodiment of the present
invention.
DETAILED DESCRIPTION
[0019] In view of the foregoing background of the invention, it is
an object of the present invention to provide a breast-lift
procedure which does not require long incisions and can be
performed with a minimally-invasive procedure.
[0020] It is also an object of the present invention to provide a
breast-lift and NAC-lift procedure, which reduces the pain, and
discomfort suffered by the patient and reduces the recovery time of
the patient.
[0021] It is a further object of the present invention to provide a
breast-lift and NAC-lift procedure, which reduces the risk of
scarring and scar tissue formation.
[0022] It is a still further object of the present invention to
provide a breast-lift and NAC-lift procedure with reduced incidence
of side effects such as temporary loss of sensation and
infection.
[0023] These and other objects of time present invention are
accomplished as described in the drawings and detailed description
of the invention by providing a minimally-invasive breast-lift
and/or NAC-lift procedure that utilizes one or more lengths of
barbed suture material introduced through tiny punctures to lift
and contour the breast and/or lift the NAC. The invention provides
a range of procedures for deploying the bidirectional sutures
depending upon the lifting and contouring effects desired to be
achieved and the patient's anatomy.
[0024] In a general embodiment, one or more lengths of
bidirectionally-barbed suture are introduced through puncture
wounds above the breast and fixated to a stable anatomical feature
such as the fascia pectoralis. Long needles are utilized to deploy
both ends of the suture caudally from the insertion point through
breast tissue to exit lower on the breast. The deployment lines and
deployment depth are controlled to achieve the desired effects.
When the sutures are in place, the breast tissues are manually
advanced along the sutures until the desired elevation and
contouring is achieved. The barbs on the sutures are oriented to
optimally support the tissue against gravity along the length of
the sutures and maintain the desired contouring and elevation. In
this manner, the effects of surgical mastopexy can be achieved
without long incisions and the associated disadvantages of pain,
scarring, and possible loss of sensation.
[0025] Other objects, advantages, and embodiments of the invention
are set forth in part in the drawings, the description which
follows, and in part, will be obvious from the drawings and the
description, or may be learned from the practice of the
invention.
Barbed Sutures
[0026] Referring now to the drawings, wherein like reference
numerals designate corresponding or similar elements throughout the
several views, there is shown in FIGS. 1, 2A, 2B and 2C a
bidirectional barbed suture for use according to the present
invention and generally designated at 100. Suture 100 includes an
elongated body 102 having a plurality of barbs 104 disposed along
the length of the body 102. First and second ends 106, 108 of body
102 are affixed to needles 110, 112 for penetrating tissue. Needles
110, 112 each have: a proximal end 114, 116 for receiving suture
100; an elongate shaft 118, 120; and a sharp distal tip 122, 124
for penetrating tissue in a controllable and steerable manner.
Needles 110, 112 are shown as straight needles but they may be
curved as necessitated by the demands of the procedure.
[0027] Body 102 of suture 100 is, in one embodiment, circular in
cross section. Suitable diameters for body 102 of suture 100 may
range from about 0.001 mm to about 1.0 mm. In general, body 102 of
suture 100 should be sized such that it has sufficient tensile
strength to serve in its intended application but does not cause
unnecessary least disruption to the tissues through which it
passes. Body 102 of suture 100 could also have a non-circular
cross-sectional shape, which would increase the surface area of
body 102 and facilitate the formation of multiple barbs 104.
[0028] The plurality of barbs 104 is axially spaced along body 102
of suture 100. Barbs 104 are oriented in one direction facing
toward the first end 106 of the suture 100 for a first portion 128
of the length of the suture and in an opposite direction facing the
second end 108 of the suture 100 for a second portion 126 of the
suture. Optionally suture 100 may also be unbarbed in a third
portion 129 located between barbed section 128 and needle 110, and
fourth portion 127 located between barbed section 126 and needle
112. These additional portions of the suture need not be barbed as
they will not remain in the patient after deployment but they are
useful during deployment. These portions can be left unbarbed to
make them stronger and easier to handle during the procedure.
[0029] Barbs 104 are yieldable toward body 102 as shown by arrow
202 of FIG. 2A. Barbs 104 on each portion 126, 128 of suture 100
are oriented to allow movement of suture 100 through the tissue in
one direction along with the corresponding end 106, 108 of suture
100. Arrow 204 of FIG. 2A indicates the direction in which body 102
may move through tissue. Barbs 104 are generally rigid in an
opposite direction to prevent suture 100 from moving in the tissue
in the opposite direction. Section 130 between sections 126,128 is
unbarbed to increase its tensile strength. Suture 100 could be
formed in one piece or could be formed from two sutures each with
barbs oriented in one direction. Two sutures 100 could be tied or
joined together at their ends.
[0030] Barbs 104 can be arranged in any suitable pattern, for
example, in a helical pattern. The number, configuration, spacing
and surface area of barbs 104 can vary depending upon the tissue in
which suture 100 is used, and depending on the composition and
geometry of the suture body. The proportions of barbs 104 may
remain relatively constant while the overall length of barbs 104
and the spacing of barbs 104 are determined by the tissue being
connected. If suture 100 is intended for use in fatty parenchymal
tissue, which is relatively soft, barbs 104 can be made longer and
spaced farther apart to increase the holding ability in the soft
tissue. Moreover, the ratio of the number of barbs 104 on the first
portion 126 of the suture 100 to the number of barbs 104 on the
second portion 128, and the lengths of each portion 126, 128, 130
can vary depending on the application and needs. The length of
suture 100 and sections 126, 127, 128, 129, 130 can vary depending
on several factors such as variations in patient anatomy and the
particular deployment pattern selected. A suture 100 of proper
length is selected for achieving suitable results in a particular
application.
[0031] The surface area of the barbs 104 can also vary. For
example, fuller-tipped barbs 104 can be made of varying sizes
designed for specific surgical applications. For joining fat and
relatively soft tissues, larger barbs 104 are desired, whereas
smaller barbs 104 are more suited for collagen-dense tissues. There
are also situations where a combination of large and small barbs
104 within the same structure will be beneficial such as when a
suture 100 is used in tissue repair with differing layer
structures. Use of the combination of large and small barbs 104
with the same suture 100 wherein barb 104 sizes are customized for
each tissue layer will ensure maximum anchoring properties.
[0032] One method of creating barbed suture is to take a standard
suture thread and cut barbs with a desired geometry. As shown in
FIG. 2A, barbs 104 can be specified by a number of characteristics.
Cut angle 209 defines the angle at which a blade enters the suture
to cut the barb. Barb length 206 defines the length of the cut made
into the suture at the cutting angle. Barb spacing 207 is the axial
distance between adjacent barbs. Cut depth 208 is the maximum depth
of the cut into the suture measured radially. The cut depth 208 is
dependent upon the cut angle 209 and cut length 206. The cut depth
needs to be chosen based on the diameter 205 of suture 100 such
that suture 100 has enough tensile strength to perform the tasks
for which it is intended. The barbs can be arranged in any suitable
pattern on the suture. The barbs are shown in FIG. 2A on opposite
sides of body 102 for ease of explanation. However, as shown in
FIG. 2B, a cross-sectional view along the axis of body 102, the
geometry of the barbs can be defined by the angle X between
adjacent barbs 104. If the barbs are cut by a single blade, the
suture material may be rotated between cuts, in which case, angle X
is controlled by the number of times suture body 102 is rotated per
unit distance.
[0033] Material for the body 102 of the suture 100 is available in
a wide variety of monofilament suture material. The particular
suture material chosen depends on the strength and flexibility
requirements. In one embodiment, the material for body 102 is
flexible and substantially nonresilient so that the shape of an
inserted suture 100 will be determined by the line of insertion and
the surrounding tissue. In some applications, however, it may be
desirable for at least a portion of the body 102 to have sufficient
dimensional stability to assume a substantially rigid configuration
during use and sufficient resiliency to return to a predetermined
position after deflection therefrom. Variations in surface texture
of the body 102 of the suture 100 can impart different interaction
characteristics with tissues.
[0034] Body 102 of suture 100 may be formed from non-absorbable
material such as nylon, polyethylene terephthalate (polyester),
polypropylene, and expanded polytetrafluoroethylene (ePTFE).
Alternatively, suture body 102 can also be formed of metal (e.g.
steel), metal alloys, plastic, or the like. It is also desirable
that the material be of high tensile strength and low visibility.
In one embodiment, the suture is formed from transparent polyester
so as to reduce its visibility after implantation.
[0035] The needles may be constructed of stainless steel or other
surgical grade metal alloy. The length of the needles is selected
to serve the type of tissue being repaired so that the needles can
be completely removed leaving the suture body 102 in the desired
position within the tissue. In one embodiment of the present
invention, the needles are 11-inch long straight needles with a
taper tip having a cutting edge only on one side. An advantage of
this type of tip is that it pushes away tissue at the tip rather
than severing it as the needle passes. This reduces disruption to
the tissues as the suture is deployed and reduces bruising and
recovery time.
[0036] The needles may be secured to the suture body 102 by means
of adhesives, crimping, swaging or the like, or the joint may be
formed by heat shrinkable tubing. Alternatively the suture 100 may
pass through an eye provided in the needle. A controlled-release
connection may also be employed such that the needles may be
removed from the body 102 of the suture 100 by a sharp tug or
pull.
[0037] In one embodiment of a bidirectional suture for use in a
breast-lift procedure such as shown in FIGS. 4A-4D, 5A-5L, 7A,B,D,
the suture material is a clear, non-absorbable, sterile surgical
strand of polypropylene of USP Size 2. Polypropylene is a suitable
material for this application because polypropylene threads elicit
a minimal acute inflammatory reaction in tissue. Implantation of
polypropylene threads is followed by gradual encapsulation,
however, polypropylene is not absorbed, and no known change in
tensile strength in vivo has been identified.
[0038] In one embodiment for use in a breast-lift procedure, suture
100 is 111 cm long, barbed sections 126, 128 are each 19 cm long,
unbarbed section 130 is 5 cm long and unbarbed sections 127, 129
are each 34 cm long. In another embodiment, suture 100 is 129 cm
long, barbed sections 126, 128 are each 21.9 cm long, unbarbed
section 130 is 5 cm long and unbarbed sections 127, 129 are each 40
cm long. The dimensions of the barbed section 126, 128 of suture
100 allow the suture to be deployed and support tissues along the
entire length of the deployment paths required to perform the
procedure. The additional unbarbed lengths 127, 129 of suture 100
allow insertion and withdrawal of the 11 inch needles during suture
deployment but are not required to be barbed as they will not
remain implanted in the patient.
[0039] In one embodiment for use in a breast-lift procedure, barbs
104 are cut into a standard USP size 2 polypropylene suture
material with a circular cross-section. The barbs on barbed
sections 126, 128 are defined as follows: cut angle 209 is 12
degrees; cut length 206 is 0.0320 inches; cut depth 208 is
0.0068''.+-.0.0034 inches; and the distance 207 between barbs is
0.373 inches. The suture is rotated 2.21 times per inch of suture
and there are approximately 27 barbs per inch, thus angle X between
adjacent barbs is approximately 30 degrees. In one embodiment the
minimum tensile strength of the suture after creation of barbs 104
is 8.0 lbs.
[0040] In one embodiment for use in a breast-lift procedure, the
ends 106, 108 of suture 100 are swaged to the proximal ends 114,
116 of surgical needles 110, 112. For this embodiment, the needles
are specified as: 470S/S, 0.039 inch diameter, 11 inches long with
a taper cutting point. Needles 110, 112 are secured at each end of
the body 102 of the suture 100 so that body 102 extends between the
shank ends of the two needles (proximal ends 114, 116). As shown in
FIG. 2C, needle 110 has an axial hole 210 at end 114 in which end
106 of suture 100 is swaged according to standard practice.
[0041] In one embodiment of a suture for an NAC-lift procedure in
accordance with FIGS. 6A-6D, 7C,D the suture material is clear,
non-absorbable, sterile surgical strand of polypropylene of USP
Size 1-0. In one embodiment, suture 100 is 129 cm long, barbed
sections 126, 128 are each 21.9 cm long, unbarbed section 130 is 5
cm long and unbarbed sections 127, 129 are each 40 cm long. The
dimensions of the barbed section 126, 128 of suture 100 allow the
suture to be deployed and support tissues along the entire length
of the deployment paths required to perform the procedure. The
additional unbarbed lengths 127, 129 of suture 100 allow insertion
and withdrawal of the 11 inch needles during suture deployment but
are not required to be barbed as they will not remain implanted in
the patient.
[0042] In one embodiment of a suture for an NAC-lift procedure
barbs 104 are cut into a standard USP size 1-0 polypropylene suture
material with a circular cross-section. The barbs on barbed
sections 126, 128 are cut into defined as follows: cut angle 209 is
12 degrees; cut length 206 is 0.0216 inches; cut depth 208 is
0.0046''.+-.0.0023 inches; and the distance 207 between barbs is
0.373 inches. The suture is rotated 2.21 times per inch of suture
and there are approximately 27 barbs per inch, thus angle X between
adjacent barbs is approximately 30 degrees. In one embodiment the
minimum tensile strength of the suture after creation of barbs 104
is 4.5 lbs.
[0043] In one embodiment of a suture for an NAC-lift procedure, the
ends 106, 108 of suture 100 are swaged to the proximal ends 114,
116 of surgical needles 110, 112. For this embodiment, the needles
are specified as: 470S/S, 0.039 inch diameter, 11 inches long with
a taper cutting point. Needles 110, 112 are secured at each end of
the body 102 of the suture 100 so that body 102 extends between the
shank ends of the two needles (proximal ends 114, 116). As shown in
FIG. 2C, needle 110 has an axial hole 210 at end 114 in which end
106 of suture 100 is swaged according to standard practice.
Surgical Procedures
[0044] The present invention provides a surgical procedure that
uses one or more barbed sutures 100 to perform a minimally-invasive
breast-lift or NAC-lift. In general, the procedure comprises the
following steps: placement, fixation, deployment and elevation.
Additionally, after the elevation step, any puncture wounds or
incisions can be closed in standard surgical fashion. In the
placement step, the physician locates and marks on the skin of the
patient the insertion and exit points for the sutures, and the
deployment lines along which the sutures will travel. The
deployment lines are selected so that the suture, when deployed,
engages the area of tissue required to be repositioned to achieve
the desired effects. In the fixation step, the surgeon fixes the
suture to a stable anatomical feature such as the fascia pectoralis
to prevent movement or migration of an anchored portion of the
suture and creates a fixation point or anchor. In the deployment
step, the physician inserts the suture in a generally caudal or
caudal and lateral direction along deployment lines between the
insertion points and the exit points at a deployment depth selected
based upon the type of tissues required to be engaged to achieve
the desired effect. In the elevation step the physician applies
tension to the free ends of the suture and manually groups and
advances the tissues along the suture to achieve the desired
elevation and contouring of the breast tissue. The barbs on the
suture are oriented in such a way that the barbs along the length
of the suture support the tissues in the elevated position. In the
closing step, the physician removes the needles used during
deployment, cuts off the excess suture material and closes the
insertion and exit wounds.
[0045] After surgery, the patient is provided with appropriate
post-operative care in accordance with standard post-operative
practice. Subjects may be provided with breast support during
recovery from the procedure. Breast support may include tape
applied to the breast. For example, two pieces of two inch tape may
be applied to the chest horizontally, medially and laterally with
the tape touching at each corner of the lower pole of the breast.
This creates a supportive "U" shape around/on the breast.
Additionally, breast support may be provided in the form of a
support bra.
[0046] As described above, in the fixation step, the surgeon fixes
the suture to a stable anatomical feature to prevent movement of an
anchored portion of the suture and creates a fixation point. One
way to anchor the suture and create a fixation point is to loop the
suture through the fascia pectoralis. The fascia pectoralis is a
thin inelastic lamina of connective tissue, covering the surface of
the muscles of the chest (pectoralis major). The fascia pectoralis
is attached, in the middle line, to the front of the sternum; and
above, to the clavicle. The fascia pectoralis is a stable
anatomical feature that provides a strong and immobile anchor for
the suture and thus prevents migration of the suture. The stability
of the fascia pectoralis as an anchor is enhanced in regions
proximate to the sternum and clavicle where the fascia pectoralis
is connected to a bone.
[0047] FIG. 3. illustrates preparation the physician may make prior
to placement of the sutures. During preparation for the procedure,
the physician identifies particular anatomical features on the
patient and marks navigational lines in ink on the patient to aid
with the procedure. For example, the physician may identify, and
mark if needed, the following anatomical reference points: sternal
notch 302, clavicle 304, outline of second rib 306, nipple 308,
areolus 310, midline 312, transethial line through the center of
the nipple 314, natural breast vector 317 from the nipple through
the sternal notch, inframammary fold 316, vertical line 315 and
lowest contour line 318. Vertical line 315 is shown passing from
the nipple to a position 6 cm along the inferior border of the
clavicle. Lowest contour line 318 is marked on the most pendent
edge of the breast with the patient in an upright position.
Navigation lines 314, 315, 317, and 318 are useful guides for
determining the location of insertion and exit points and the
appropriate trajectories for deployment of the sutures. The
navigational lines are shown as dotted lines in FIG. 3 in order to
avoid confusion with the anatomical features of the chest, however,
a surgeon usually marks solid lines in ink on the patient during
preparation for the procedure. Also shown in FIG. 3 are the
relative directions: cranial 320 meaning towards the head; caudal
322 meaning toward the posterior; medial 324 meaning close to the
midline; and lateral 326 meaning away from the midline. Other
descriptors of direction may be used in this application as may be
inferred from the context, for example, above, and higher may refer
to a more cranial location, while below, lower and lowest may refer
to a more caudal direction.
[0048] After identifying the anatomical markers of the patient, the
physician may prepare for placement of the suture. As shown in the
example breast-lift procedure of FIG. 4A, the physician marks
insertion points 402, insertion-exit point 404, and exit points
406, 408 on the patient's skin using a marker. In one embodiment,
points 402 and 404 are marked over the second rib one centimeter
either side of natural breast vector 317 from the sternal notch to
the nipple. As will be illustrated later, insertion-exit point 404
serves both as an exit point and an insertion point. In addition to
the insertion and exit points, the physician also marks the
intended trajectory of the suture on the patient's skin as
indicated by dashed lines 410, 412, 414. Placement depends on the
anatomy of the patient and the aesthetic effects desired by the
patient. In general, for a breast-lift, the insertion points are
above or cranial to the exit points on the breast. Depending on the
anatomy, the insertion points may also be placed medial of the exit
points as shown if FIG. 4A. In addition, the insertion points are
located so as to allow anchoring of the suture to a stable
anatomical feature such as the fascia pectoralis or the periosteum
of a bone such as the clavicle, a rib or the sternum.
[0049] As shown in FIG. 4A insertion points 402, 404 are located
over the outline of second rib 306. The location of the insertion
points over the second rib reduces the risk of injury to the
patient by perforation of the pleural membrane or by damage to the
perforators of the breast. As shown in the embodiment of FIG. 4A,
the long deployment lines 412, 414 pass in a generally caudal and
lateral direction from the insertion points 402 404 to the exit
points 406, 408. The shorter deployment line 410 is approximately
horizontal along second rib 306 providing a stable anchor point.
Fixation to the fascia pectoralis may be achieved along a
deployment line between an insertion and exit point or may be
achieved at a single site by looping through the fascia pectoralis
at that site. Fixation point or anchor as used herein should not be
limited to a single point but should encompass all appropriate
methods of fixating the suture to the selected stable anatomical
feature. By way of example, fixation of the suture to a stable
anatomical feature, to create affixation point or anchor, could be
achieved using an anchoring device placed in the tissue to which
the suture is attached.
[0050] Prior to deployment of the sutures, the patient should be
anaesthetized or sedated. In an open mastopexy procedure, a general
anesthesia with its concomitant risks is always required. For the
minimally-invasive procedure of the present invention, some
patients may only require local anesthesia. Infiltration of local
anesthetic along the deployment lines may be accomplished using a
long small bore needle. The patient may be sedated if necessary.
Some patients may still require general anesthesia to tolerate the
procedure, but a significant number will not.
[0051] FIG. 4B illustrates the fixation step. As shown in FIG. 4B,
the physician makes a puncture wound 422, 424, 426, 428 at each of
the previously marked insertion and exit points 402, 404, 406, 408
respectively. One advantage of a puncture or stab wound is that the
wound is more likely to close and heal without stitches or
scarring. The creation of the puncture wound at the insertion
points allows the surgeon to more safely penetrate the required
tissues without excessive force. If the skin has already been
punctured using a skin puncture device, when the physician
introduces the needle he may better judge the depth of the needle
and the force required to enter the selected tissues. However, the
needles may be introduced and exit through the skin without the
prior creation of puncture wounds if the surgeon is experienced
with the techniques required.
[0052] After creation of the puncture wounds, if required, the
physician inserts tip 122 of needle 110 into puncture wound 422
deep enough to penetrate the fascia pectoralis and directs tip 122
of needle 110 through the fascia pectoralis along deployment line
410 towards puncture wound 424. When tip 122 of needle 110 exits
the fascia pectoralis through puncture wound 424 the physician
takes hold of tip 122 and draws needle 110 and section 128 of
suture 100 through the fascia pectoralis until section 130 of
suture 100 lies between puncture wounds 422, 424 along deployment
line 410 with a little of section 130 protruding from each puncture
wound. Section 126 of suture 100 is not drawn into puncture wound
422, as the barbs on section 126 would obstruct motion through the
tissue in that direction. Obviously, puncture wound 424 could be
used as the insertion point and puncture wound 422 as the
insertion-exit point to achieve the same result. The particular
order in which the deployment is made is generally not important so
long as the desired deployment pattern and orientation of the
sutures can be achieved. After the fixation step, suture 100 is in
the position shown in FIG. 4B. Section 130 of suture 100 is
anchored in the fascia pectoralis over the second rib.
[0053] In an alternative method of introducing suture 100, a
14-gauge angiocatheter is inserted from insertion point 402 to
insertion-exit point 404 through the fascia pectoralis along
deployment line 410. The needle is then inserted into the catheter
in a retrograde fashion along deployment line 410 from insertion
point 422 to exit point 424. The catheter is removed when the tip
of the needle has exited insertion-exit point 404 and the procedure
continued in the same manner described above. Advantages of using
an angio-catheter are that it can be used to safely make the
punctures for introduction of the needle, and can reduce the risk
of injury to the patient from the tip of the needle.
[0054] FIG. 4C illustrates the deployment step in which the
physician deploys suture 100 along the deployment lines 412, 414.
The physician first inserts tip 122 of needle 110 into puncture
wound 424 and directs tip 122 of needle 110 through the breast
tissue along deployment line 412 towards puncture wound 428. Note
that, in this example, puncture wound 424 serves both as an
insertion point and as an exit point for suture 100. During
deployment, the physician may palpate the skin while introducing
needle 110 to ensure that needle 110 passes at the correct depth in
the tissue along deployment line 412.
[0055] The deployment depth determines the type of tissues to be
engaged by the suture. If the desire is to lift the breast as a
whole, the depth of deployment should be through deeper fatty and
fibrous parenchymal tissues of the breast gland. If however, it is
desired to selectively position or contour surface features of the
breast, such as the skin of the breast and the nipple-areola
complex (NAC), the deployment may be along a shallower subcutaneous
line. The location of the deployment lines determines the area of
tissues to be engaged by a suture. The combination of the location
of the deployment lines and the depth of suture deployment will
determine the type of tissues engaged and the aesthetic effects
that elevation of the tissue along the suture will achieve.
[0056] Referring again to FIG. 4C, when tip 122 of needle 110 exits
through puncture wound 428 the physician takes hold of tip 122 and
draws needle 110 and section 128 of suture 100 through the tissue.
The physician then repeats this process inserting tip 124 of needle
112 through puncture wound 422 along deployment line 414 and out
through puncture wound 426. As shown in FIG. 4C, as suture 100 is
drawn into the tissue, loops 430 and 432 of suture 100 remain
external to puncture wounds 422, 424 until suture 100 is pulled
tight. When the suture is pulled tight, section 130 of suture 100
is anchored in the fascia pectoralis over the second rib 306,
section 128 of suture 100 has been deployed in the tissue of the
patient between puncture wounds 424 and 428 along deployment line
412 and section 126 of suture 100 has been deployed in the tissue
of the patient between puncture wounds 422 and 426 along deployment
line 414. At this point, the needles are no longer required and may
be removed from the suture.
[0057] Depending on the aesthetic effects desired, a physician may
choose to deploy multiple sutures in the manner described above.
For example, a physician may deploy one suture through deep breast
structures and another suture along a shallower subcutaneous line.
In this way, control of both elevation of the breast gland and
elevation and contouring of the breast surface may be achieved.
[0058] FIG. 4D illustrates the elevation step. In the elevation
step, the physician applies light tension as shown by arrows 440,
442 to sections 126 and 128 of suture 100 outside of the patient's
body. Section 126, 128 of suture 100 may be gripped by hemostats in
order to facilitate application of tension. The application of
tension to the suture maintains the suture stationary relative to
the fixation points during elevation. The physician may then
manually advance the patient's tissues along the barbed portions
126, 128 of suture 100 beneath deployment lines 412 and 414 in the
direction shown by arrows 444 and 446 to achieve the desired
lifting effect. Barbs 104 of both sections 126, 128 of suture 100
are oriented such that they yield toward the suture to allow the
breast tissue to be elevated in the direction of arrow 446, 444.
However, barbs 104 of suture 100 grasp the tissue and prevent it
from moving in the direction opposite to arrows 444, 446. Thus, the
suture maintains the elevation of the breast tissues relative to
the anchor point. An advantage of the procedures of the present
invention is that the barbs are oriented so as to support the
tissue along the entire length of the deployed suture. This
orientation of the barbs 104 provides support and contouring of the
tissues along the entire length of the deployed suture.
[0059] During the elevation step, the physician may raise the
patient to a sitting position to evaluate whether the desired
amount of lifting has been achieved. The physician continues
advancing the tissues along the sutures until in his judgment the
desired aesthetic effect is achieved. If multiple sutures are
deployed, the physician may deploy all the sutures prior to
elevation. Alternatively, the physician may complete the elevation
step with respect to a first suture before deciding upon the need
for or placement of a second suture.
[0060] After the desired aesthetic effect has been achieved, the
physician cuts off the excess suture material and closes the
insertion and exit points. In one embodiment, ends of the suture
100 in the tissue are made to lie below the surface of the skin by
first depressing the skin immediately around the ends and severing
suture body 102 closely against the skin. The skin will rise to
cover the ends of the suture 100. The puncture wounds may be closed
in any suitable conventional manner. However, it is desired that
the puncture wounds be closed in a manner that leaves no
scarring.
[0061] FIGS. 5A-5L illustrate alternative deployment patterns that
may be used in accordance with embodiments of the present
invention. In each of FIGS. 5A-5L the suture is deployed in a
similar manner to that described above with respect to FIGS. 4A-4D.
In general, as previously described, a suture is first fixated at
an insertion point (which could be a single puncture wound or a
deployment line) to a stable anatomical feature such as the fascia
pectoralis. The two ends of the suture are then deployed in a
caudal or caudal and lateral direction through the selected breast
tissues. The breast tissues are then elevated relative to the
fixation point by applying light tension to the suture and manually
grouping and advancing the tissue along the suture. In each of
these deployments, barbs 104 are oriented such that barbs 104
retain and support the elevated tissues against gravity.
[0062] FIG. 5A illustrates one alternative embodiment of the
present invention. FIG. 5A shows insertion point 501,
insertion-exit point 502, exit points 503, 504, and deployment
lines 505, 506, 507. In this embodiment, the physician fixates a
barbed suture by first deploying the suture from insertion point
501 to insertion-exit point 502. The physician may direct the
suture though the fascia pectoralis over the second rib providing a
stable anchor point for the suture. Optionally, the suture may also
be directed through the periosteum of the second rib. The physician
then deploys the suture from insertion point 501 along deployment
line 506 to exit point 503 and from insertion-exit point 502 along
deployment line 507 to exit point 504. Deployment lines 506 and 507
pass in a generally caudal direction to either side of NAC 309.
After passing NAC 309, the more lateral deployment line 507 curves
outward more laterally to exit point 504, while the more medial
deployment line 506 curves more medially to exit point 503. In one
embodiment, the suture is deployed at a shallow subcutaneous depth
along deployment lines 506, 507 to contour the surface structures
of the breast. This deployment pattern may be used to elevate the
NAC with respect to the breast and also conize the breast by
displacing tissues below the NAC towards the NAC.
[0063] FIG. 5B illustrates one alternative embodiment of the
present invention comprising a deployment pattern that utilizes two
sutures. This deployment pattern combines the deployment pattern of
FIG. 4A with the deployment pattern of FIG. 5A. In the combined
deployment pattern, insertion-exit point 404 of the first suture is
shared with insertion point 501 of the second suture. Both of these
deployment points will be in the same puncture wound thereby
reducing the number of puncture wounds required and reducing the
potential for scarring. Depending on the particular anatomy of the
patient it may be desirable that a larger or greater number of the
puncture wounds be shared between sutures. The fewest number of
puncture wounds should be utilized to achieve the desired
deployment. In the one implementation of the deployment pattern of
FIG. 5B, a first suture is deployed through deep fibrous and fatty
parenchymal tissue of the breast along deployment lines 414 and 412
and a second suture is deployed through shallow subcutaneous
tissues of the breast along deployment lines 506, 507. The first
suture allows elevation of the breast, while the second suture
allows elevation of the NAC relative to the breast and contouring
of the surface of the breast. During the elevation step, tension
will first be applied to the suture that has been deployed through
the deep fibrous and fatty parenchymal tissue of the breast and
this breast will be manually grouped and advanced along this suture
until the desired breast-lift achieved. After the desired
breast-lift is achieved, tension will then be applied to the suture
deployed through the shallow subcutaneous tissues and the skin of
the breast and the NAC will be manually grouped and advanced along
this suture until the desired NAC-lift and contouring of the breast
surface is achieved.
[0064] FIG. 5C illustrates one alternative embodiment of the
present invention comprising a deployment in which insertion point
511 serves as both the insertion point and the first exit point.
This reduces the number of puncture wounds required and thereby
reduces the potential for scarring. The deployment pattern of FIG.
5C, comprises insertion-exit point 511, exit points 512, 513 and
deployment lines 514, 515. Insertion point 511 is located proximate
to clavicle 304. A suture is first fixated to the fascia pectoralis
proximate to the clavicle at insertion point 511. Optionally, the
suture may also be directed through the periosteum of the clavicle.
The suture is then deployed in a generally caudal direction along
deployment lines 514, 515 to exit points 512, 513 which are located
one either side of NAC 309 and cranially of NAC 309. The deployment
paths flare out to either side of the breast as they approach the
NAC which allows tissues to be drawn in towards the vertical line
315 during the elevation step. The suture may be deployed through
shallow subcutaneous tissues of the breast and this deployment to
provide contouring of the surface of the breast including
conization, and elevation of NAC 309 with respect to the
breast.
[0065] FIG. 5D also illustrates one alternative embodiment of the
present invention comprising a deployment in which insertion point
521 serves both as the insertion point and as the first exit point.
This reduces the number of puncture wounds required and reduces the
potential for scarring. The deployment pattern of FIG. 5D comprises
insertion-exit point 521, exits points 522, 523 and deployment
lines 524, 525. Insertion-exit point 521 is located proximate to
clavicle 304. A suture is first fixated to the fascia pectoralis
proximate the clavicle at insertion-exit point 521. The suture is
then deployed in a generally caudally direction along deployment
lines 524, 525 to exit points 522, 523 which are located one either
side of NAC 309 and caudally of NAC 309 on the lower curvature of
the breast. The suture may be deployed through deep fibrous and
fatty parenchymal tissue of the breast to allow for elevation of
the breast as a whole.
[0066] FIG. 5E illustrates one alternative embodiment of the
present invention comprising a deployment pattern combining the
deployment patterns of FIGS. 5C, 5D. As shown in FIG. 5E, insertion
points 511, 521 may be located at the same point thereby reducing
the number of puncture wounds required. In the implementation of
this deployment pattern, a first suture is deployed along
deployment lines 514, 515 through shallow subcutaneous tissue and a
second suture is deployed through fibrous and fatty parenchymal
tissue of the breast along deployment lines 524, 525. This
deployment pattern allows for elevation of the breast as well as
elevation of the NAC relative to the breast. FIG. 5F shows another
deployment pattern combining the deployment patterns of FIGS. 5C,
5D except that that insertion points 521 and 511 are not located at
the same point. Instead, insertion point 521 is displaced caudally
of insertion point 511. As with the two-suture deployment of FIG.
5B, the elevation of the breast utilizing the deployment pattern of
FIGS. 5E, 5F may also be performed in two stages. First, elevation
of the breast along the deep suture, and second, when the breast
has been elevated, elevation of the NAC and contouring of the skin
along the shallow suture.
[0067] FIG. 5G illustrates another embodiment of the present
invention. As shown in FIG. 5G, the deployment pattern comprises
insertion-exit point 531, exit points 532, 533 and deployment lines
534, 535. Insertion-exit point 531 is located on the upper
curvature of the breast proximate to the midline. At the
insertion-exit point the barbed suture may be fixated to the fascia
pectoralis proximate to the sternum. After fixation, the suture is
deployed caudally and laterally along deployment lines 534 and 535
towards exit points 532, 534 on the lower curvature of the breast.
The deployment lines may pass through deep fatty and fibrous tissue
of the breast parenchyma. The deployment lines allow for elevation
of the breast and repositioning of the breast towards the
midline.
[0068] FIG. 5H. illustrates the deployment pattern of FIG. 5G. in
combination with a second suture. The deployment of the second
suture comprises insertion-exit point 541, exit points 542, 543 and
deployment lines 544, 545. Insertion-exit point 541 is shown at the
same location as insertion-exit point 531, however it may also be
displaced slightly from insertion point 541. In one implementation
a second suture is fixated to the fascia pectoralis proximate the
sternum at insertion point 541. The suture is then deployed
caudally and laterally along deployment lines 544, 545 to exit
points 542, 543. Deployment may be through subcutaneous tissues to
allow for surface contouring and elevation of the NAC relative to
the breast. FIG. 5I illustrates an alternative embodiment of the
deployment pattern of FIG. 5H. As shown in FIG. 5I, insertion point
541 is displaced more medially than insertion point 531 and is
positioned over the sternum. The sternum provides a stable anchor
point as the fascia pectoralis is attached to the front of the
sternum.
[0069] FIG. 5J illustrates an alternative deployment pattern. As
shown in FIG. 5J, deployment pattern comprise insertion point 551
proximate clavicle 304, insertion-exit point 553 and exit points
552, 554. The pattern is implemented by fixating the suture to the
fascia pectoralis at insertion point 551 and then deploying the
suture along deployment lines 555, 556 towards exit points 553,
554. Exit point 552 is shown located at approximately the level of
the third rib. Deployment line 556 passes first through
insertion-exit point 553. At insertion-exit point 553 the suture is
brought out through the skin and then reintroduced through the same
point. This insertion-exit point allows for the direction of the
deployment line to be changed. Although the deployment lines may be
curved, there is a limit to how sharp a change in needle direction
may be made. If a sharp change in deployment direction is desired,
an intermediate insertion-exit point may be useful in order to
accomplish the change in direction.
[0070] FIG. 5K illustrates a variation on the deployment pattern of
FIG. 5J. In this deployment, a suture is first anchored through the
fascia pectoralis over second rib 306 along deployment line 567.
Both ends of the suture are then deployed caudally to either side
of NAC along deployment lines 568, 569 to exit points 566, 564 on
the lower curvature of the breast. Intermediate insertion-exit
points 563 and 565 may be utilized if necessary to achieve the
desired curvature in the deployment trajectory. A suture deployed
in this fashion can cradle the breast tissue allowing for elevation
of the breast and NAC during the elevation step.
[0071] FIG. 5L illustrates a deployment pattern involving three
bidirectional sutures. Referring to FIG. 5L, the deployment lines
for each of the three sutures are shown with a distinct line
pattern. The deployment pattern for the first suture, indicated by
the small-dash line, comprises insertion point 571, insertion-exit
point 572, exit points 573, 574 and deployment lines 575, 576, 577.
The first suture is deployed by first fixating the suture to the
fascia pectoralis proximate the second rib along deployment line
575 between insertion point 571 and insertion-exit point 572;
deploying one end of the suture caudally from insertion point 571
to exit point 573; and deploying the other end caudally from
insertion-exit point 572 to exit point 574. The deployment pattern
for the second suture, indicated by the large-dash line, comprises
insertion point 581, insertion-exit point 582, exit points 583, 584
and deployment lines 585, 586, 587. The second suture is deployed
by first fixating the suture to the fascia pectoralis proximate the
second rib along deployment line 585 between insertion point 581
and insertion-exit point 582; deploying one end of the suture
caudally from insertion point 581 to exit point 583; and deploying
the other end caudally from insertion-exit point 582 to exit point
584. The deployment pattern for the third suture, indicated by the
solid line, comprises insertion point 591, exit points 593, 594 and
deployment lines 596, 597. The third suture is deployed by first
fixating the suture to the fascia pectoralis proximate the clavicle
at insertion point 591; deploying one end of the suture caudally
from insertion point 591 to exit point 593; and deploying the other
end caudally from insertion point 591 to exit point 594. The first
and second sutures may be deployed through deeper fatty and fibrous
parenchymal tissues of the breast to allow elevation of the breast.
The third suture may be deployed through shallow subcutaneous
tissue to position the NAC and contour the skin of the elevated
breast. In practice, all three sutures may be deployed prior to
elevation. During the first stage of the elevation step, the first
and second (deep) sutures will be held under tension while the
breast is advanced along deployment lines 576, 586, 577, 587.
Finally, after the desired breast elevation is achieved, the third
suture will be held under tension and the skin of the breast and
the NAC will be advanced along deployment line 596, 597 until the
NAC is at the desired height and the skin of the breast has the
aesthetic contour desired.
[0072] FIGS. 6A-6D illustrate an alternative method of suture
deployment for lifting the NAC relative to the breast. As shown if
FIG. 6A, the deployment pattern comprises insertion point 602,
insertion-exit points 604, 606, 610, exit points 608, 612, and
deployment lines 620, 622, 624, 626 and 628. As shown in FIG. 6B,
suture 100 is introduced at insertion point 602 and deployed along
deployment line 620 to insertion-exit point 604. Both insertion
point 602 and insertion-exit point 604 are located in the areolus
310 surrounding nipple 308. Suture 100 is drawn along deployment
line 620 until the unbarbed section 130 of suture 100 is located
along deployment line 620. A little portion of unbarbed section 130
of suture 100 may protrude from insertion point 602 and
insertion-exit point 604 at this stage as shown in FIG. 6B.
[0073] As shown in FIG. 6C, suture 100 is then deployed cranially
from insertion point 602 along deployment line 626 to
insertion-exit point 610. Likewise, suture 100 is deployed
cranially from insertion-exit point 604 along deployment line 622
to insertion-exit point 606. The deployment is through shallow
subcutaneous tissues. After deployment has reached this point, the
NAC may be elevated into the desired position by drawing suture 100
upward as shown by arrows 630, 632, through insertion-exit points
606, 610. In one embodiment NAC 309 is elevated, in the direction
shown by arrow 634, from 1 cm to no more than 3 cm. This degree of
elevation permits the NAC to be elevated without elevating the
breast tissue. In an alternative embodiment, the NAC can be raised
more than 3 cm and the breast may also be elevated to some extent.
The barbs on the suture are oriented to restrict the suture from
being drawn back through the exit points after the NAC has been
elevated.
[0074] As shown in FIG. 6D, after the NAC has been elevated by the
desired amount, the suture is deployed from insertion-exit point
606 along deployment line 624 through the fascia pectoralis to exit
point 608. Likewise, the suture is deployed from insertion-exit 610
along deployment line 628 through the fascia pectoralis to exit
point 612. The deployment through the fascia pectoralis fixates the
ends of the suture thereby stabilizing the elevation of NAC 309.
The needles and excess suture may then be removed and the puncture
wounds closed as previously described. In an alternative
deployment, instead of fixating suture 100 in the fascia pectoralis
with a further caudal deployment, suture 100 may be fixated to the
fascia pectoralis at exit points 606, 610 using a surgeon's knot.
If necessary or desired, a second bidirectional suture may be
deployed in a similar manner to the first with the second
deployment pattern displaced from the first.
[0075] The NAC-lift procedure of FIGS. 6A-6D may be used in
combination with the deployment of other sutures to elevate the
breast as shown in any of FIGS. 4A-D and 5A-K. A combination of
breast-lift and nipple-lift using barbed sutures allows the surgeon
to achieve many of the effects of a conventional mastopexy
procedure without large incisions. One embodiment of a surgical
procedure which combines both a breast-lift and a NAC-lift is shown
in FIGS. 7A-D. The deployment pattern of FIGS. 7A-D employs three
bidirectional sutures. The combination of three sutures in this way
allows for control of breast-lift as well as NAC-lift relative to
the breast and contouring of the breast to enhance conization.
[0076] A first suture 100 is deployed as shown in FIG. 7A. The
deployment pattern comprises insertion point 721, insertion-exit
point 722 and exit points 723 and 724. Insertion point 721 is over
the second rib 1 cm medial of natural breast vector line 317.
Insertion point 722 is over the second rib 1 cm lateral of natural
breast vector line 317. Exit points 724 are both on lowest contour
line 318. A fourteen gauge angiocatheter is looped between
insertion points 721 and 722 gathering up the fascia pectoralis and
the posterior lamella of the breast fascia overlying the second
rib. A first needle is then inserted in retrograde fashion into the
tip of the angiocatheter and pushed through the angiocatheter until
the tip of the needle exits the insertion point of the
angiocatheter. The angiocatheter is then removed and the tip of the
needle can be grasped and drawn out of the insertion point. Suture
100 can then be drawn through the deployment path 725 until
unbarbed section 130 lies between the two insertion points 721,
722, with a little of unbarbed section 130 remaining at each
insertion point. One end of a suture is then deployed caudally
along deployment line 727 from insertion point 721 to exit point
724. The other end of the suture is then deployed caudally along
deployment line 726 from insertion point 722 to exit point 723. The
deployment depth is selected so that the suture passes through deep
fatty and fibrous parenchymal tissue in the middle of the breast
gland. Note that the deployment angles out immediately below
transthelial line 314. The suture can then be drawn along
deployment lines 726, 727 until no portion remains above the skin
at insertion points leaving the barbed sections of the suture
within the breast tissue with the barbs 104 oriented as shown.
[0077] A second suture 100 is then deployed as shown in FIG. 7B.
The deployment pattern comprises insertion point 711,
insertion-exit point 712 and exit points 713 and 714. In this
deployment, insertion points 711 and 722 share the same location,
reducing the number of punctures necessary. Insertion point 712 is
placed over the second rib between insertion point 722 and vertical
line 315 at a position selected based on the elevation axis
desired. A fourteen gauge angiocatheter is looped between insertion
points 711 and 712 gathering up the fascia pectoralis and the
posterior lamella of the breast fascia overlying the second rib. A
first needle is then inserted in retrograde fashion into the tip of
the angiocatheter and pushed through the angiocatheter until the
tip of the needle exits the insertion point of the angiocatheter.
The angiocatheter is then removed and the tip of the needle can be
grasped and drawn out of the insertion point. Suture 100 can then
be drawn through the deployment path 715 until unbarbed section 130
lies between the two insertion points 711, 712, with a little of
unbarbed section 130 remaining at each insertion point. One end of
a suture is then deployed caudally along deployment line 717 from
insertion point 711 to exit point 714. The other end of the suture
is then deployed caudally along deployment line 716 from insertion
point 712 to exit point 713. The deployment depth is selected so
that the suture passes through deep fatty and fibrous parenchymal
tissue in the middle of the breast gland. Note that the deployment
angles out immediately below transthelial line 314. The suture can
then be drawn along deployment lines 716, 717 until no portion
remains above the skin at insertion points leaving the barbed
sections of the suture within the breast tissue with the barbs 104
oriented as shown. The second suture, may alternatively be deployed
at a more shallow depth if sufficient elevation is expected with
the first suture, or more contouring of the breast surface is
desired.
[0078] After the deployment of the first two sutures as shown in
FIGS. 7A, 7B, the breast may be elevated by grouping and advancing
the breast tissue along the long deployment lines 716, 717, 726,
727 of the first and second bidirectional (deep) sutures while
maintaining tension on the free ends of the first and second
bidirectional (deep) sutures. The elevation step is performed with
the patient in an upright position in order to gauge the aesthetic
effects achieved. Because these sutures are deployed in the deeper
fatty and fibrous parenchymal tissues of the breast, the grouping
and advancing of the breast tissue elevates the breast as a whole
towards second rib 306.
[0079] A third bidirectional suture is then deployed as shown in
FIG. 7 C. The deployment pattern comprises insertion point 731,
insertion-exit point 732, 733 and 734. Insertion point 731 and
insertion-exit point 732 are located in NAC 309 above nipple 308.
Insertion-exit points 733 and 734 may be located over the third rib
on vectors from NAC 309 along which NAC 309 is desired to be
positioned. The NAC will have moved during the elevation of the
breast gland and so the location of these insertion-exit points may
be selected after breast elevation to achieve the desired location
of NAC 309 on the elevated breast. As shown in FIG. 7C, the third
suture is deployed between insertion point 731 and insertion-exit
point 732 along deployment line 735. A needle is first inserted at
insertion point 731 and pushed through the tissues of the NAC and
out insertion-exit point 732. The deployment depth is through
shallow structures of the NAC but the deployment depth is deep
enough to avoid extrusion of the suture over time. Suture 100 is
then drawn along deployment line 735 until the unbarbed section 130
of suture 100 is located along deployment line 735 within the
tissues of the NAC. The suture is then deployed cranially along
deployment lines 736, 737 to exit points 733, 734 proximate the
third rib. The deployment depth is controlled such that the third
suture is deployed through shallow subcutaneous tissue.
[0080] The NAC may then be repositioned relative to the breast.
This is achieved by applying tension to the third bidirectional
suture and pulling the suture up through the insertion-exit points
733, 734 proximate the third rib. When the desired NAC position has
been achieved the suture is deployed in a downward direction from
insertion-exit points 733, 734 to exit points 736, 737. The suture
penetrates through the fascia pectoralis between insertion-exit
points 733, 734 and exit points 736, 737 thus anchoring the suture
to a stable anatomical feature in order to maintaining the desired
position of the NAC.
[0081] The position of the breast tissues on the three sutures may
be adjusted by the physician with the patient in an elevated
position until the physician, in his or her judgment, has achieved
the aesthetic result desired. After the elevation is complete to
the physician's satisfaction, the free ends of the suture may be
cut off and the exit wounds closed. This embodiment of the present
invention, by utilizing a combination of three sutures, allows for
control of breast-lift, as well as positioning the NAC relative to
the breast and contouring the tissues above the NAC.
[0082] The foregoing description of embodiments of the present
invention has been provided for the purposes of illustration and
description. It is not intended to be exhaustive or to limit the
invention to the precise forms disclosed. The deployment patterns
described may be modified and combined in accordance with the
principles described to provide the breast and NAC elevation,
medial displacement and contouring desired in a particular case in
light of the patient's anatomy. Many embodiments were chosen and
described in order to explain the principles of the invention and
its practical application, thereby enabling others skilled in the
art to understand the invention for various embodiments and with
various modifications that are suited to the particular use
contemplated. It is intended that the scope of the invention be
defined by the claims and their equivalents.
* * * * *