U.S. patent application number 11/866985 was filed with the patent office on 2008-04-03 for minimally invasive tissue support.
This patent application is currently assigned to ALURE MEDICAL, INC.. Invention is credited to Gordon Bishop, Randy Lashinski.
Application Number | 20080082113 11/866985 |
Document ID | / |
Family ID | 39269204 |
Filed Date | 2008-04-03 |
United States Patent
Application |
20080082113 |
Kind Code |
A1 |
Bishop; Gordon ; et
al. |
April 3, 2008 |
MINIMALLY INVASIVE TISSUE SUPPORT
Abstract
Embodiments of apparatus and methods for tissue lifting, or for
correcting a ptosis condition caused by tissue stretching, are
described. In some embodiments a tissue is supported by a support
member. In some embodiments, tension is applied to a support member
through at least one suspension member. The described embodiments
provide examples of methods and apparatus effective for use in
lifting or otherwise applying tension to various tissues, including
tissues of the breast, buttock, thigh, arm, abdomen, neck and
face.
Inventors: |
Bishop; Gordon; (Santa Rosa,
CA) ; Lashinski; Randy; (Santa Rosa, CA) |
Correspondence
Address: |
MCDERMOTT WILL & EMERY LLP
18191 VON KARMAN AVE.
SUITE 500
IRVINE
CA
92612-7108
US
|
Assignee: |
ALURE MEDICAL, INC.
675 Pleasant Avenue
Santa Rosa
CA
95403
|
Family ID: |
39269204 |
Appl. No.: |
11/866985 |
Filed: |
October 3, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60828006 |
Oct 3, 2006 |
|
|
|
60933179 |
Jun 4, 2007 |
|
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Current U.S.
Class: |
606/151 ;
128/898; 606/192; 606/232 |
Current CPC
Class: |
A61B 2090/3908 20160201;
A61B 17/00234 20130101; A61B 17/06166 20130101; A61F 2/0059
20130101; A61B 2017/00411 20130101; A61L 17/00 20130101; A61B
2017/0618 20130101; A61F 2/0063 20130101; A61B 2017/00792 20130101;
A61M 29/00 20130101; A61B 2017/00557 20130101; A61F 2/12 20130101;
A61B 2017/06176 20130101; A61L 17/06 20130101; A61B 2017/00867
20130101; A61B 2017/00893 20130101; A61B 2017/00796 20130101; A61L
17/145 20130101 |
Class at
Publication: |
606/151 ;
128/898; 606/192; 606/232 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. A device, for use in supporting a tissue in a patient's body,
comprising; a support member, adapted to engage at least a portion
of a tissue, the support member comprising a first end and a second
end, the support member further comprising a plurality of support
elements; and first and second suspension members, the first
suspension member being coupled to the first end of the support
member, the second suspension member being coupled to the second
end of the support member; wherein at least one of the first and
second suspension members is configured to be secured to a location
in the patient's body; wherein the plurality of support elements is
configured to distribute a load, from the tissue engaged by the
support member, imposed on the support member; and wherein at least
one of the first and second suspension members is configured to
transmit a force through the support member, the force effective to
move the engaged portion of the tissue from a first position to a
second position.
2. The device of claim 1, wherein the first suspension member is
coupled to each support element at a first end of each support
element, and the second suspension member is coupled to each
support element at a second end of each support element.
3. The device of claim 1, wherein the second position is superior
to the first position.
4. The device of claim 1, wherein the second position is at least
one of posterior, medial, and lateral, relative to the first
position.
5. The device of claim 1, wherein the second position is posterior
to the first position.
6. The device of claim 1, wherein each of the plurality of support
elements is elongate and has a length extending along an arc, or
line, that extends between the first end of the support member and
the second end of the support member; wherein a first of the
plurality of support elements is spaced apart from a second of the
plurality of support elements along at least about 10% of a length
of the first of the plurality of support elements; and wherein the
length of the plurality of support elements extends from the first
end of the support member to the second end of the support
member.
7. The device of claim 1, wherein a first of the plurality of
support elements is spaced apart from a second of the plurality of
support elements along at least about 30% of a length of the first
of the plurality of support elements; and wherein the length of the
plurality of support elements extends from the first end of the
support member to the second end of the support member.
8. The device of claim 1, wherein at least one of the support
elements is fusiform shaped.
9. The device of claim 1, wherein at least one suspension member is
configured to be secured to at least one of muscle, fascia, bone,
ligament, tendon, and skin.
10. The device of claim 1, wherein the portion of the tissue being
engaged comprises at least one of breast tissue, buttock tissue,
facial tissue, arm tissue, abdominal tissue, and leg tissue.
11. The device of claim 1, wherein each support element comprises
at least one of an elongate member and a mesh.
12. The device of claim 1, wherein each of the plurality of support
elements is coupled to a separator, effective to maintain spacing
between adjacent support elements.
13. The device of claim 1, wherein the support member comprise an
engagement member, effective to limit movement of the support
member relative to the engaged portion of the tissue.
14. The device of claim 13, wherein the engagement member comprises
at least one of a barb, a hook, and a suture.
15. The device of claim 1, wherein at least a portion of the device
comprises a biodegradable material.
16. The device of claim 1, further comprising a coating effective
to enhance at least one of biocompatibility and healing.
17. A device, for use in supporting a tissue in a patient's body,
comprising; a support member, adapted to engage at least a portion
of a tissue, the support member comprising a first end, a second
end, and an inflatable portion therebetween; wherein, upon
inflation, the inflatable portion is effective to increase an
apparent volume of the tissue; first and second suspension members,
the first suspension member being coupled to the first end of the
support member, and the second suspension member being coupled to
the second end of the support member; wherein at least one of the
first and second suspension members is configured to be secured to
a location in the patient's body; wherein the support member is
configured to distribute a load imposed on the support member from
the tissue engaged by the support member; and wherein at least one
of the first and second suspension members is configured to
transmit a force through the support member, the force effective to
move the engaged portion of the tissue from a first position to a
second position.
18. The device of claim 17, wherein the second position is superior
to the first position.
19. The device of claim 17, wherein the second position is at least
one of posterior, medial, and lateral, relative to the first
position.
20. The device of claim 17, wherein the tissue being supported
comprises at least one of breast tissue, buttock tissue, facial
tissue, arm tissue, abdominal tissue, and leg tissue.
21. The device of claim 17, wherein the inflatable portion
comprises pleats.
22. The device of claim 17, further comprising a port for inflating
the inflatable portion.
23. The device of claim 22, wherein the port is in or on at least
one of the suspension members.
24. A device, for use in supporting tissue, comprising; a support
member, adapted to engage at least a portion of a tissue, the
support member comprising a first end and a second end; wherein the
support member is configured to distribute a load imposed on the
support member from the tissue engaged by the support member; and
first and second suspension members, the first suspension member
being coupled to the first end of the support member and the second
suspension member being coupled to the second end of the support
member; wherein at least one suspension member is configured to be
secured to a location at least about 5 cm away from the engaged
portion of the tissue; wherein at least one of the first suspension
member, the second suspension member, and the support member
comprises an elastic element; wherein at least one of the first and
second suspension members is configured to transmit a force through
the support member, the force effective to move the engaged portion
of the tissue from a first position to a second position; and
wherein the elastic element is configured to permit movement of the
engaged portion of the tissue from the second position toward the
first position.
25. The device of claim 24, wherein the second position is superior
to the first position.
26. The device of claim 24, wherein the second position is at least
one of posterior, medial, and lateral, relative to the first
position.
27. The device of claim 24, wherein the portion of the tissue being
engaged comprises at least one of breast tissue, buttock tissue,
facial tissue, arm tissue, abdominal tissue, and leg tissue.
28. The device of claim 24, wherein the elastic element comprises
at least one of an elastomeric core and an elastomeric cover.
29. The device of claim 24, wherein the elastic element comprises a
spring.
30. The device of claim 24, wherein the at least one suspension
member comprises a braided portion.
31. The device of claim 24, wherein at least a portion of the
elastic element has a nonlinear elastic constant.
32. The device of claim 24, further comprising a channel member
through which at least a portion of a suspension member passes,
when the device is implanted in the body; wherein the channel
member is configured to limit contact of surrounding tissue by the
portion of the suspension member.
33. The device of claim 32, wherein the channel member is
tubular.
34. A device, for use in supporting a tissue in a patient's body,
comprising; a support member, adapted to engage at least a portion
of a tissue, the support member comprising a first end and a second
end; wherein the support member is configured to distribute a load
imposed on the support member from the tissue engaged by the
support member; first and second suspension members, the first
suspension member being coupled to the first end of the support
member, and the second suspension member being coupled to the
second end of the support member; and a disconnect member,
configured to release tension in the suspension member when a load
on the device exceeds a threshold load; wherein at least one of the
suspension members is configured to be secured to a location in the
patient's body; and wherein at least one of the suspension members
is configured to transmit a force through the support member, the
force effective to move an engaged portion of the tissue of the
patient from a first position to a second position.
35. The device of claim 34, wherein the second position is superior
to the first position.
36. The device of claim 34, wherein the second position is at least
one of posterior, medial, and lateral, relative to the first
position.
37. The device of claim 34, wherein the portion of the tissue being
engaged comprises at least one of breast tissue, buttock tissue,
facial tissue, arm tissue, abdominal tissue, and leg tissue.
38. The device of claim 34, wherein the disconnect member is
configured to separate a first portion of at least one of the
suspension members from a second portion of the at least one of the
suspension members in response to the load that exceeds the
threshold.
39. The device of claim 34, wherein the disconnect member is
configured to separate at least one of the suspension members from
the support member in response to the load that exceeds the
threshold.
40. A device, for use in supporting a tissue in a patient's body,
comprising: an elongate suspension member, having a first end and a
second end, and a length extending therebetween; wherein the
suspension member is configured to engage, and exert traction on, a
tissue, resulting in the tissue moving from a first position to a
second position; wherein at least a portion of suspension member is
configured to shorten along the length of the suspension member in
response to delivery of an energy to the suspension member; wherein
the suspension member further comprises at least one engagement
member, configured to engage at least a portion of the tissue; an
elongate energy delivery member, coupled to at least a portion of
the suspension member; wherein at least a portion of the elongate
energy delivery member extends alongside at least a portion of the
length of the suspension member; and wherein the elongate energy
delivery member is configured to deliver the energy to the
suspension member.
41. The device of claim 40, wherein the energy comprises at least
one of electromagnetic energy, acoustic energy, and thermal
energy.
42. The device of claim 40, wherein the at least a portion of the
elongate suspension member comprises collagen.
43. The device of claim 40, wherein the at least a portion of the
elongate suspension member comprises at least one of a shape memory
alloy and a shape memory polymer.
44. The device of claim 40, wherein the at least a portion of the
elongate suspension member comprises a swellable material.
45. The device of claim 44, wherein the swellable material
comprises a hydrogel.
46. The device of claim 40, wherein the at least a portion of the
elongate suspension member comprises a braid.
47. A method, for supporting a breast in a body of a patient,
comprising: providing a supporting device having a first end, a
second end, and a support member positioned between the first end
and second end; advancing the first end of the supporting device
into a breast, through a first incision that is located on one of a
medial and a lateral side of the breast; withdrawing the first end
of the supporting device from the breast through a second incision,
located on the other of the medial and the lateral side of the
breast, until the support member is positioned within breast tissue
between the first incision and second incision; advancing the first
end of the supporting device, from a position within the breast
adjacent the second incision, to a first location, and the second
end of the supporting device, from a position within the breast
adjacent the first incision, to a second location; wherein both of
the first and second locations are superior to the first and second
incisions; drawing the breast tissue toward the first and second
locations; and anchoring the first and second ends of the
supporting device at the first and second locations,
respectively.
48. The method of claim 47, wherein the first and second locations
are substantially the same location.
49. The method of claim 47, further comprising coupling a portion
of the first end to a portion of the second end, inside the
body.
50. The method of claim 47, wherein anchoring comprises coupling
the first and second ends to at least one of bone, muscle, fascia,
tendon, ligament, and skin.
51. A method, for supporting a tissue in a body of a patient,
comprising: placing a supporting device into the body, the
supporting device comprising: a support member, adapted to engage
at least a portion of a tissue, the support member comprising a
first end and a second end; wherein the support member is
configured to distribute a load imposed on the support member from
the tissue engaged by the support member; at least one suspension
member coupled to the support member; engaging the at least a
portion of the tissue with the support member; applying tension to
the at least one suspension member, thereby moving the engaged
portion of the tissue from a first position to a second position;
securing the at least one suspension member to a location in the
body, such that the engaged portion of the tissue is effectively
maintained in the second position; and inflating at least a portion
of the supporting device to increase an apparent volume of the
tissue.
52. The method of claim 51, wherein the portion of the tissue being
engaged comprises at least one of breast tissue, buttock tissue,
facial tissue, arm tissue, abdominal tissue, and leg tissue.
53. A method, for supporting a tissue in a body of a patient,
comprising: placing a supporting device into the body, the
supporting device comprising: a support member, adapted to engage
at least portion of a tissue, the support member comprising a first
end and a second end; wherein the support member is configured to
distribute a load imposed on the support member from the tissue
engaged by the support member; and at least one suspension member
coupled to the support member; placing the support member so as to
effectively engage at least a portion of the tissue; applying
tension to the at least one suspension member, thereby moving the
engaged portion of the tissue from a first position to a second
position; securing the at least one suspension member to a location
in the body, such that the engaged portion of the tissue is
effectively maintained substantially in the second position; and
wherein the supporting device is configured, in response to a load
that exceeds a threshold, to release tension in the at least one
suspension member.
54. The device of claim 53, wherein the supporting device is
configured to uncouple a first portion of at least one of the
suspension members from a second portion of the at least one of the
suspension members in response to the load that exceeds the
threshold.
55. The device of claim 53, wherein the supporting device is
configured to uncouple at least one of the suspension members from
the support member in response to the load that exceeds the
threshold.
56. The method of claim 53, wherein the at least one suspension
member increases in length when the load exceeds the threshold.
57. A method, for use in supporting breast tissue in a patient's
body, comprising: providing a support member, adapted to engage
breast tissue, the support member comprising a first end and a
second end; wherein the support member is configured to distribute
a load imposed on the support member from the breast tissue engaged
by the support member; and providing first and second suspension
members, the first suspension member being coupled to the first end
of the support member and the second suspension member being
coupled to the second end of the support member; wherein, when
implanted, the first suspension member, extends superiorly from the
first end of the support member, and the second suspension member,
extends superiorly from the second end of the support member;
anchoring the first suspension member at a first location, and the
second suspension member at a second location; wherein the first
and second locations are located superiorly to the engaged breast
tissue; wherein a distance between the first and second locations
is greater than a greatest distance between the first and second
ends of the support member.
58. A method, for use in supporting a tissue in a patient's body,
comprising: providing an elongate suspension member, having a first
end and a second end, and a length extending therebetween; wherein
the suspension member is configured to engage, and exert traction
on, a tissue, resulting in the tissue moving from a first position
to a second position; wherein at least a portion of suspension
member is configured to shorten along the length of the suspension
member in response to delivery of an energy to the suspension
member; wherein the suspension member further comprises at least
one engagement member, configured to engage at least a portion of
the tissue; providing an elongate energy delivery member, coupled
to at least a portion of the suspension member; wherein at least a
portion of the energy delivery member extends alongside at least a
portion of the length of the suspension member; and wherein the
energy delivery member is configured to deliver the energy to the
suspension member; delivering the energy to the energy delivery
member, thereby shortening the suspension member.
59. The method of claim 58, wherein delivering energy comprises
delivering at least one of electromagnetic energy, acoustic energy,
and thermal energy.
Description
RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application No. 60/828,006, filed Oct. 3, 2006, and entitled
"Tissue Lift and Support Means," and U.S. Provisional Application
No. 60/933,179, filed Jun. 4, 2007, and entitled "Apparatus and
Methods for Minimally Invasive Mastopexy," the entire contents of
all of which are hereby incorporated by reference.
FIELD OF THE INVENTION
[0002] Embodiments of the invention are useful in the field of
minimally invasive surgical devices and methods, in particular
devices and methods for use in mastopexy.
BACKGROUND OF THE INVENTION
[0003] Ptosis is a condition in a tissue or organ of the body where
the tissue or organ sags, or falls, with respect to its previous
position in the body. A variety of surgical and non-surgical
procedures and devices have been developed to restore tissues and
organs to a previous position. In particular, cosmetic surgery is
frequently directed at restoring tissues to a pre-sag position.
[0004] For example, in mastopexy, mammary ptosis is corrected using
a surgical procedure, without altering breast volume. In
augmentation, breast volume is increased, while in reduction
surgery, breast volume is decreased. Procedures can include
combinations of mastopexy and augmentation or reduction procedures
as well.
SUMMARY OF THE INVENTION
[0005] Embodiments as disclosed herein are directed to minimally
invasive methods of tissue support.
[0006] In some embodiments, there is provided a device, for use in
supporting a tissue in a patient's body, comprising; a support
member, adapted to engage at least a portion of a tissue, the
support member comprising a first end and a second end, the support
member further comprising a plurality of support elements; and
first and second suspension members, the first suspension member
being coupled to the first end of the support member, the second
suspension member being coupled to the second end of the support
member; wherein at least one of the first and second suspension
members is configured to be secured to a location in the patient's
body; wherein the plurality of support elements is configured to
distribute a load, from the tissue engaged by the support member,
imposed on the support member; and wherein at least one of the
first and second suspension members is configured to transmit a
force through the support member, the force effective to move the
engaged portion of the tissue from a first position to a second
position.
[0007] In some embodiments, the first suspension member is coupled
to each support element at a first end of each support element, and
the second suspension member is coupled to each support element at
a second end of each support element.
[0008] In some embodiments, the second position is superior to the
first position. In some embodiments, the second position is at
least one of posterior, medial, and lateral, relative to the first
position. In some embodiments, the second position is posterior to
the first position.
[0009] In some embodiments, each of the plurality of support
elements is elongate and has a length extending along an arc, or
line, that extends between the first end of the support member and
the second end of the support member; wherein a first of the
plurality of support elements is spaced apart from a second of the
plurality of support elements along at least about 10% of a length
of the first of the plurality of support elements; and wherein the
length of the plurality of support elements extends from the first
end of the support member to the second end of the support
member.
[0010] In some embodiments, a first of the plurality of support
elements is spaced apart from a second of the plurality of support
elements along at least about 30% of a length of the first of the
plurality of support elements; and wherein the length of the
plurality of support elements extends from the first end of the
support member to the second end of the support member.
[0011] In some embodiments, at least one of the support elements is
fusiform shaped.
[0012] In some embodiments, at least one suspension member is
configured to be secured to at least one of muscle, fascia, bone,
ligament, tendon, and skin. In some embodiments, the portion of the
tissue being engaged comprises at least one of breast tissue,
buttock tissue, facial tissue, arm tissue, abdominal tissue, and
leg tissue.
[0013] In some embodiments, each support element comprises at least
one of an elongate member and a mesh.
[0014] In some embodiments, each of the plurality of support
elements is coupled to a separator, effective to maintain spacing
between adjacent support elements.
[0015] In some embodiments, the support member comprises an
engagement member, effective to limit movement of the support
member relative to the engaged portion of the tissue. In some
embodiments, the engagement member comprises at least one of a
barb, a hook, and a suture.
[0016] In some embodiments, at least a portion of the device
comprises a biodegradable material. In some embodiments, the device
further comprises a coating effective to enhance at least one of
biocompatibility and healing.
[0017] In some embodiments, there is provided a device, for use in
supporting a tissue in a patient's body, comprising; a support
member, adapted to engage at least a portion of a tissue, the
support member comprising a first end, a second end, and an
inflatable portion therebetween; wherein, upon inflation, the
inflatable portion is effective to increase an apparent volume of
the tissue; first and second suspension members, the first
suspension member being coupled to the first end of the support
member, and the second suspension member being coupled to the
second end of the support member; wherein at least one of the first
and second suspension members is configured to be secured to a
location in the patient's body; wherein the support member is
configured to distribute a load imposed on the support member from
the tissue engaged by the support member; and wherein at least one
of the first and second suspension members is configured to
transmit a force through the support member, the force effective to
move the engaged portion of the tissue from a first position to a
second position.
[0018] In some embodiments, the second position is superior to the
first position. In some embodiments, the second position is at
least one of posterior, medial, and lateral, relative to the first
position.
[0019] In some embodiments, the tissue being supported comprises at
least one of breast tissue, buttock tissue, facial tissue, arm
tissue, abdominal tissue, and leg tissue.
[0020] In some embodiments, the inflatable portion comprises
pleats. In some embodiments, the device further comprises a port
for inflating the inflatable portion. In some embodiments, the port
is in or on at least one of the suspension members.
[0021] In some embodiments, there is provided a device, for use in
supporting tissue, comprising; a support member, adapted to engage
at least a portion of a tissue, the support member comprising a
first end and a second end; wherein the support member is
configured to distribute a load imposed on the support member from
the tissue engaged by the support member; and first and second
suspension members, the first suspension member being coupled to
the first end of the support member and the second suspension
member being coupled to the second end of the support member;
wherein at least one suspension member is configured to be secured
to a location at least about 5 cm away from the engaged portion of
the tissue; wherein at least one of the first suspension member,
the second suspension member, and the support member comprises an
elastic element; wherein at least one of the first and second
suspension members is configured to transmit a force through the
support member, the force effective to move the engaged portion of
the tissue from a first position to a second position; and wherein
the elastic element is configured to permit movement of the engaged
portion of the tissue from the second position toward the first
position.
[0022] In some embodiments, the second position is superior to the
first position. In some embodiments, the second position is at
least one of posterior, medial, and lateral, relative to the first
position.
[0023] In some embodiments, the portion of the tissue being engaged
comprises at least one of breast tissue, buttock tissue, facial
tissue, arm tissue, abdominal tissue, and leg tissue.
[0024] In some embodiments, the elastic element comprises at least
one of an elastomeric core and an elastomeric cover. In some
embodiments, the elastic element comprises a spring.
[0025] In some embodiments, the at least one suspension member
comprises a braided portion. In some embodiments, at least a
portion of the elastic element has a nonlinear elastic
constant.
[0026] In some embodiments, the device further comprises a channel
member through which at least a portion of a suspension member
passes, when the device is implanted in the body; wherein the
channel member is configured to limit contact of surrounding tissue
by the portion of the suspension member. In some embodiments, the
channel member is tubular.
[0027] In some embodiments, there is provided a device, for use in
supporting a tissue in a patient's body, comprising; a support
member, adapted to engage at least a portion of a tissue, the
support member comprising a first end and a second end; wherein the
support member is configured to distribute a load imposed on the
support member from the tissue engaged by the support member; first
and second suspension members, the first suspension member being
coupled to the first end of the support member, and the second
suspension member being coupled to the second end of the support
member; and a disconnect member, configured to release tension in
the suspension member when a load on the device exceeds a threshold
load; wherein at least one of the suspension members is configured
to be secured to a location in the patient's body; and wherein at
least one of the suspension members is configured to transmit a
force through the support member, the force effective to move an
engaged portion of the tissue of the patient from a first position
to a second position.
[0028] In some embodiments, the second position is superior to the
first position. In some embodiments, the second position is at
least one of posterior, medial, and lateral, relative to the first
position. In some embodiments, the portion of the tissue being
engaged comprises at least one of breast tissue, buttock tissue,
facial tissue, arm tissue, abdominal tissue, and leg tissue.
[0029] In some embodiments, the disconnect member is configured to
separate a first portion of at least one of the suspension members
from a second portion of the at least one of the suspension members
in response to the load that exceeds the threshold. In some
embodiments, the disconnect member is configured to separate at
least one of the suspension members from the support member in
response to the load that exceeds the threshold.
[0030] In some embodiments, there is provided a device, for use in
supporting a tissue in a patient's body, comprising: an elongate
suspension member, having a first end and a second end, and a
length extending therebetween; wherein the suspension member is
configured to engage, and exert traction on, a tissue, resulting in
the tissue moving from a first position to a second position;
wherein at least a portion of suspension member is configured to
shorten along the length of the suspension member in response to
delivery of an energy to the suspension member; wherein the
suspension member further comprises at least one engagement member,
configured to engage at least a portion of the tissue; an elongate
energy delivery member, coupled to at least a portion of the
suspension member; wherein at least a portion of the elongate
energy delivery member extends alongside at least a portion of the
length of the suspension member; and wherein the elongate energy
delivery member is configured to deliver the energy to the
suspension member.
[0031] In some embodiments, the energy comprises at least one of
electromagnetic energy, acoustic energy, and thermal energy. In
some embodiments, the at least a portion of the elongate suspension
member comprises collagen. In some embodiments, the at least a
portion of the elongate suspension member comprises at least one of
a shape memory alloy and a shape memory polymer. In some
embodiments, the at least a portion of the elongate suspension
member comprises a swellable material. In some embodiments, the
swellable material comprises a hydrogel. In some embodiments, the
at least a portion of the elongate suspension member comprises a
braid.
[0032] In some embodiments, there is provided a method, for
supporting a breast in a body of a patient, comprising: providing a
supporting device having a first end, a second end, and a support
member positioned between the first end and second end; advancing
the first end of the supporting device into a breast, through a
first incision that is located on one of a medial and a lateral
side of the breast; withdrawing the first end of the supporting
device from the breast through a second incision, located on the
other of the medial and the lateral side of the breast, until the
support member is positioned within breast tissue between the first
incision and second incision; advancing the first end of the
supporting device, from a position within the breast adjacent the
second incision, to a first location, and the second end of the
supporting device, from a position within the breast adjacent the
first incision, to a second location; wherein both of the first and
second locations are superior to the first and second incisions;
drawing the breast tissue toward the first and second locations;
and anchoring the first and second ends of the supporting device at
the first and second locations, respectively.
[0033] In some embodiments, the first and second locations are
substantially the same location.
[0034] In some embodiments, the method further comprises coupling a
portion of the first end to a portion of the second end, inside the
body. In some embodiments, anchoring comprises coupling the first
and second ends to at least one of bone, muscle, fascia, tendon,
ligament, and skin.
[0035] In some embodiments, there is provided a method, for
supporting a tissue in a body of a patient, comprising: placing a
supporting device into the body, the supporting device comprising:
a support member, adapted to engage at least a portion of a tissue,
the support member comprising a first end and a second end; wherein
the support member is configured to distribute a load imposed on
the support member from the tissue engaged by the support member;
at least one suspension member coupled to the support member;
engaging the at least a portion of the tissue with the support
member; applying tension to the at least one suspension member,
thereby moving the engaged portion of the tissue from a first
position to a second position; securing the at least one suspension
member to a location in the body, such that the engaged portion of
the tissue is effectively maintained in the second position; and
inflating at least a portion of the supporting device to increase
an apparent volume of the tissue.
[0036] In some embodiments, the portion of the tissue being engaged
comprises at least one of breast tissue, buttock tissue, facial
tissue, arm tissue, abdominal tissue, and leg tissue.
[0037] In some embodiments, there is provided a method, for
supporting a tissue in a body of a patient, comprising: placing a
supporting device into the body, the supporting device comprising:
a support member, adapted to engage at least portion of a tissue,
the support member comprising a first end and a second end; wherein
the support member is configured to distribute a load imposed on
the support member from the tissue engaged by the support member;
and at least one suspension member coupled to the support member;
placing the support member so as to effectively engage at least a
portion of the tissue; applying tension to the at least one
suspension member, thereby moving the engaged portion of the tissue
from a first position to a second position; securing the at least
one suspension member to a location in the body, such that the
engaged portion of the tissue is effectively maintained
substantially in the second position; and wherein the supporting
device is configured, in response to a load that exceeds a
threshold, to release tension in the at least one suspension
member.
[0038] In some embodiments, the supporting device is configured to
uncouple a first portion of at least one of the suspension members
from a second portion of the at least one of the suspension members
in response to the load that exceeds the threshold. In some
embodiments, the supporting device is configured to uncouple at
least one of the suspension members from the support member in
response to the load that exceeds the threshold. In some
embodiments, the at least one suspension member increases in length
when the load exceeds the threshold.
[0039] In some embodiments, there is provided a method for use in
supporting breast tissue in a patient's body, comprising: providing
a support member, adapted to engage breast tissue, the support
member comprising a first end and a second end; wherein the support
member is configured to distribute a load imposed on the support
member from the breast tissue engaged by the support member; and
providing first and second suspension members, the first suspension
member being coupled to the first end of the support member and the
second suspension member being coupled to the second end of the
support member; wherein, when implanted, the first suspension
member, extends superiorly from the first end of the support
member, and the second suspension member, extends superiorly from
the second end of the support member; anchoring the first
suspension member at a first location, and the second suspension
member at a second location; wherein the first and second locations
are located superiorly to the engaged breast tissue; wherein a
distance between the first and second locations is greater than a
greatest distance between the first and second ends of the support
member.
[0040] In some embodiments, there is provided a method, for use in
supporting a tissue in a patient's body, comprising: providing an
elongate suspension member, having a first end and a second end,
and a length extending therebetween; wherein the suspension member
is configured to engage, and exert traction on, a tissue, resulting
in the tissue moving from a first position to a second position;
wherein at least a portion of suspension member is configured to
shorten along the length of the suspension member in response to
delivery of an energy to the suspension member; wherein the
suspension member further comprises at least one engagement member,
configured to engage at least a portion of the tissue; providing an
elongate energy delivery member, coupled to at least a portion of
the suspension member; wherein at least a portion of the energy
delivery member extends alongside at least a portion of the length
of the suspension member; and wherein the energy delivery member is
configured to deliver the energy to the suspension member;
delivering the energy to the energy delivery member, thereby
shortening the suspension member. In some embodiments, delivering
energy comprises delivering at least one of electromagnetic energy,
acoustic energy, and thermal energy.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] FIG. 1 illustrates an embodiment of a suture with molded
barbs.
[0042] FIG. 2A illustrates an embodiment of a suture with a
filamentous core and a braided portion.
[0043] FIG. 2B illustrates an embodiment of a suture like that
shown in FIG. 2A, where filaments extend outward to form barbs.
[0044] FIG. 3 illustrates an embodiment of a suture with a
separately attached barb element.
[0045] FIG. 4 illustrates the stress strain relationship among
various suture types.
[0046] FIG. 5A illustrates an embodiment of a braided suture.
[0047] FIG. 5B illustrates an embodiment of the suture shown in
FIG. 5A, with the braided portion removed to reveal the core.
[0048] FIG. 6A is a cross-sectional view of an embodiment of a
braided suture that includes a membrane lying between the braid and
the suture core.
[0049] FIG. 6B is a side view of the suture illustrated in FIG.
6A.
[0050] FIG. 7A is a cross-sectional view of an embodiment of a
braided suture impregnated with an elastomeric coating.
[0051] FIG. 7B is a perspective view of the suture illustrated in
FIG. 7A.
[0052] FIG. 8A illustrates an embodiment of a braided suture with a
hydrogel core in a pre-activation (elongated) configuration.
[0053] FIG. 8B illustrates an embodiment of a braided suture with a
hydrogel core in a post-activation (shortened) configuration.
[0054] FIG. 9 illustrates an embodiment of a suture in which
shortening of the suture is provided by a shape memory
material.
[0055] FIG. 10A is a cross-sectional view of an embodiment of a
suture having a widened portion to spread out loading and limit
cheese wiring of the suture through tissue.
[0056] FIG. 10B is a side view of the suture shown in FIG. 10A.
[0057] FIG. 11A illustrates side view of an embodiment of a suture
having a widened portion to spread out loading in an extended
conformation, where the widened portion is expandable.
[0058] FIG. 11B illustrates a suture like that shown in FIG. 11A
that has been rolled up for delivery.
[0059] FIG. 11C illustrates an end view of suture like that shown
in FIG. 11A that has been expanded.
[0060] FIG. 11D illustrates an end view of a suture like that shown
in FIG. 11A that has been expanded and then flattened.
[0061] FIG. 12A illustrates side view of an embodiment of a suture
having a widened portion, and further comprising support
members.
[0062] FIG. 12B illustrates a suture like that shown in FIG. 12
that has been rolled up for delivery.
[0063] FIG. 12C illustrates a cross-sectional view of a suture like
that shown in FIG. 12 that has been expanded.
[0064] FIG. 12D illustrates an end view suture like that shown in
FIG. 11A that has been expanded and then flattened.
[0065] FIG. 13A illustrates a perspective view of a suture with a
braided region that shortens and widens when attached sutures are
placed under tension, in an extended conformation.
[0066] FIG. 13B illustrates a perspective view of a suture like
that shown in FIG. 13A in the shortened conformation
[0067] FIG. 14A is a cross-sectional view of a suture with a flat
support region rolled into a circular cross-section for easy
placement in the patient.
[0068] FIG. 14B is a side view of the suture shown in FIG. 14A.
[0069] FIG. 15A is a cross-sectional view of a suture with a
support region comprising multiple strands that provide tissue
support.
[0070] FIG. 15B is a side view of the suture shown in FIG. 15A.
[0071] FIG. 16A illustrates a needle and sheath arrangement for use
in delivering a suture.
[0072] FIG. 16B illustrates a suture having bidirectionally
oriented barbs.
[0073] FIG. 16C illustrates a sheathed suture with barbs to engage
tissue to assist in deployment.
[0074] FIG. 16D illustrates the suture of FIG. 16C with an end
extended from the sheath as during deployment.
[0075] FIG. 16E illustrates an embodiment of a sheathed suture and
deployment sheath where the end of the suture can be bent backwards
as part of the method of deployment.
[0076] FIG. 16F illustrates an embodiment of a sheathed suture
where deployment is aided by a pushable tube.
[0077] FIG. 17A illustrates an embodiment of a curved needle for
use in deploying a suture along a curved path.
[0078] FIG. 17B illustrates a tube configured to hold a needle, and
which has a larger radius of curvature than the needle of FIG.
17A.
[0079] FIG. 17C illustrates a coaxial needle combination where the
tip of the inner needle is pulled back from the end of the outer
needle.
[0080] FIG. 17D illustrates a coaxial needle combination where the
tip of the inner needle is inserted nearly to the end of the outer
needle.
[0081] FIG. 18 illustrates an embodiment of a device for deploying
and tensioning a suture, as well as for connecting suture ends.
[0082] FIG. 19 is a side view illustrating a placement of sutures
to perform a breast lifting procedure.
[0083] FIG. 20 is a front view illustrating a placement of sutures
to perform a breast lift procedure.
[0084] FIG. 21 is a side view of a breast and an embodiment of a
support system comprising a support member and vertically oriented
suspension members.
[0085] FIG. 22 is a side view of a breast and an embodiment of a
support system comprising a support member and suspension members
oriented vertically and non-vertically.
[0086] FIG. 23 is a side view of a breast and an embodiment of a
support system comprising two types of elastomeric components, and
a safety mechanism to prevent overloading of the tissue.
[0087] FIG. 24 is a side view of a breast and an embodiment of a
support system comprising continuous length suspension members, and
a length adjustment mechanism.
[0088] FIG. 25 is a side view of a breast and an embodiment of a
support system where the support member comprises inflation
chambers.
[0089] FIG. 26 is a side view of a breast and an embodiment of a
tool for inserting and spreading or flattening a support member in
the tissue.
[0090] FIG. 27 is a side view of a breast and an embodiment of a
support member comprising barbs.
[0091] FIG. 28 is a side view of a breast and an embodiment of a
support system comprising a nipple repositioning element.
[0092] FIG. 29A is an embodiment of a support member, associated
suspension members, and needles for insertion.
[0093] FIG. 29B is a photograph of an embodiment of a support
member and attached suspension member.
[0094] FIG. 30 illustrates an embodiment of a support system
including channels for the suspension members, and spring
elements.
[0095] FIG. 31 illustrates an embodiment of a support system
comprising separators to maintain spacing between adjacent support
members.
[0096] FIG. 32 illustrates an embodiment of a support system
including an additional structural support member.
[0097] FIG. 33A-F illustrates a method of surgical placement of an
embodiment in a breast lift procedure.
[0098] FIG. 34 illustrates the use of an embodiment of a suture to
perform a neck lift procedure.
[0099] FIG. 35 illustrates the use of an embodiment of a suture to
perform an abdominal wall tightening procedure.
[0100] FIG. 36 illustrates the use of an embodiment of a suture to
perform a facelift procedure.
DETAILED DESCRIPTION OF THE INVENTION
[0101] As used herein, the term "suture" is to be construed
broadly. In general, the term "sutures" refers to simple suspension
members, while "support system" generally refers to complex,
multi-component devices that can include, without limitation, at
least one support member, and associated components such as
suspension members, elastic elements, safety mechanisms, and
anchoring portions. A support member can comprise, in some
embodiments, a plurality of support elements.
[0102] In some embodiments, a suture 10 comprising barbs 20 is
provided, as shown in FIG. 1. In some embodiments, the core 30 has
a relatively high tensile strength. High tensile strength can be
achieved by using a polymeric material in a manufacturing process
that results in a structure where the polymer chains are
substantially oriented parallel to the longitudinal axis of the
suture.
[0103] The core 30 of the suture 10 can be partially or completely
surrounded by a like, or different material, forming the barbs 20.
The properties of the suture materials can be selected on the basis
of desired absorption rates, tissue in-growth, an well as a
consideration of mechanical needs.
[0104] In some embodiments, the suture 10 is formed by extruding
the core material to form a filament. The core 30 can then be
placed in a mold that provides the barb shapes, and the mold cavity
filled with material that when solid forms the outer layer of the
suture, and the barbs 20.
[0105] In some embodiments, the core 30 can comprise multiple
filaments 33, as shown in FIG. 2A. A multiple filament design
allows the suture 10 to attain a higher ratio of axial tensile
strength compared to bending stiffness (i.e., resistance to
bending). A portion of the filaments 33 can protrude, as shown in
FIG. 2B. These protruding filaments can extend a pre-determined
distance, for example between about 0.2 and 2 mm. In some
embodiments, the ends of the protruding filaments are configured in
the shape of barbs 20. The suture can be coated with another
material or can be left uncoated.
[0106] In some embodiments of a suture 10, like that shown in FIG.
3, barbs 50 can be attached to the core 30 as separate members.
These attached barbs 50 can be secured by bonding, gluing, or
welding of the barb 50 to the outer surface of the suture core
30.
Elastic Properties
[0107] In conventional suture designs, an elastic suture typically
displays only modest extensibility. Ideally, an elastic suture used
in securing a healing wound should have sufficient elasticity to
accommodate the swelling of tissue that occurs as part of the
normal inflammatory response at the onset of healing. Additionally,
the suture should continue to provide support to the tissue or
wound, once inflammation and swelling have substantially
subsided.
[0108] When sutures are used to support tissue, as in plastic
surgery procedures, different elastic properties may be desirable.
For example, during the first part of the healing process, it is
possible for the sutures to pull out from the tissue in response to
a modest amount of longitudinally applied force. Thus, a more
elastic suture can yield enough to prevent pull-out, yet recover to
its initial length, thus providing a gradual and more effective
remodeling of tissue over time.
[0109] In some embodiments, a suture designed for use in plastic
surgery procedures, for example in a facelift procedure, is capable
of extending in length to 10-25%, while retaining the ability to
fully recover to substantially its initial length. An example of
the stress-strain curves for various types of sutures is provided
in FIG. 4. Embodiments of the present disclosure (FIG. 4, dotted
line), sutures are able to accommodate significant strain while
displaying less stress than traditional high tensile strength
sutures (FIG. 4, solid line), or even traditional elastic sutures
(FIG. 4, dashed line). Thus, examples of the disclosed suture are
capable of acting like a constant force spring, where force (i.e.,
strain) is relatively constant over a wide range of
deflections.
[0110] In some embodiments, where a large mass of relatively
immobile tissue is to be supported, for example in a breast lift
application, it can be advantageous to provide a suture with a more
progressive spring rate. In these embodiments, the stress-strain
properties of the suture or support system can be optimized to
simulate the natural biomechanical properties of the tissue. For
example, in the case of a system for supporting the breast, the
force/deflection characteristics of the support system can be
designed to simulate that of Cooper's ligaments, or the combination
of Cooper's ligaments and tissue that make up the outer structure
of the breast.
[0111] Commonly used suture materials do not normally exhibit the
properties of high elongation that are desirable in plastic surgery
procedures. Natural materials, such as collagen, do however provide
a highly extensible matrix that is useful in embodiments of the
present disclosure. Collagen based sutures are often referred to as
"gut" sutures. The source of collagen is varied and can include,
without limitation, intestinal submucosa, pericardium, and tendon,
from animals including humans, cow, pig, horse, donkey, kangaroo,
and ostriches, etc.
[0112] Where the source of collagen is a native tissue, the tissue
can be fixed in order to cross-link the collagen. Common fixatives
include glutaraldehyde. Where greater extensibility is desired,
chromic acid can be used as the fixative. Still other fixatives can
be used, and the choice of fixative is not considered to be
limiting to the scope of the present disclosure. For example,
tissues can be fixed using radiation, dehydration, or heat.
[0113] In some embodiments, the suture can comprise a core made
from a highly elastic synthetic polymer. Some suture materials can
be made from formulations that are elastic in compression but have
low strength in tension, for example hydrogel polymers. In some
embodiments, the biocompatible gelling material is a solution
containing water-insoluble polymers, for example non-cross-linked
acrylonitrile polymers or their co-polymers, polyvinyl acetate, a
linear or low-branched polymer or copolymer of
2-hydroxyethyl-acrylate and methyl acrylate,
poly-n-vinyliminocarbonile and dimethylsulfoxide or other polar or
readily water-miscible solvents, for example as disclosed in U.S.
Pat. No. 4,631,188 to Stoy et al., the contents of which are herein
incorporated by reference in their entirety. These exemplary
polymers solidify when placed in contact with living tissue as a
result of absorption of water from the tissue and gradual release
of the solvent into the surrounding tissue.
[0114] In obtaining copolymers, use can be made of additional
monomers, such as acrylamide (including N-substituted), acryl
hydrazide (including N-substituted), acrylic acid and acrylates,
glutarimide and vinyl sulfone. Solvents can include glycerol and
its mono- or diacetates, methanol, ethanol, propanol and
iso-propanol, dimethylformamide, glycols, and other suitable
solvents.
[0115] In some embodiments, the core 30 can be covered with a
braided portion 40 as shown in FIG. 5A. The braid can be made from
traditional high tensile strength suture materials. Here, the angle
of the braid can be selected such that the braided structure can
elongate from its free state. Elongating the braid results in a
decrease in the diameter of the lumen of the braid, and in turn
results in compression of the core 30, which in turn resists
further deformation of he braid. An embodiments of a suture core
with the braid 40 relaxed is shown in FIG. 5B. As indicted above,
in embodiments employing a hydrogel polymer core, the core material
will be weak in tension, but will effectively resist
compression.
[0116] In some embodiments, the core 30 can be separated from the
braided portion 40 by a membrane 60 that prevents the individual
braid filaments from cutting into the core material, as shown in
FIGS. 6A and B. Again the angle of the braids, relative to the
longitudinal axis of the core (.theta. in FIG. 6B), can be selected
such that the braid can be elongated.
[0117] In some embodiments of a highly elastic suture, the suture
includes a core 30, a braided portion, 40, all of which is
impregnated with an elastomer 70. In some embodiments the
elastomeric portion can comprise a "core" of one or more components
the device. In some embodiments, an elastomeric material can be
used to cover device components. In some embodiments, an
elastomeric material can cover other portions of the device,
providing an "elastomeric cover." For example, during manufacture,
the suture can be forced into a foreshortened configuration and
then impregnated with an elastomeric coating. The elastomer 70 can
substantially impregnate the weave of the braid 40 and is effective
to behave mechanically like an additional "core." The elastomer is
also effective to provide resistance to elongation. Neither the
composition of the elastomer, nor methods of coupling or applying
it to other components of the suture are limiting. Conveniently, in
some embodiments, the elastomer can comprise without limitation,
silicone, thermoset polyurethane, glycolide-co-caprolactone,
copolymers of lactic acid and sebacic acid, and the like, as well
as combinations of more than one elastomeric material.
Shrinkable Sutures
[0118] In some surgical applications, an advantage is provided by
embodiments that are able to gradually shrink in length over time,
or which can be made to shrink at a later time, in response to an
activation provided by a physician.
[0119] In some embodiments, a shrinkable suture 80 comprises a core
30 surrounded with a filamentous braid, as shown in FIG. 8A. Here
the angle of the braid is such that as the core is allowed to
expand in diameter it applies a force to the braid which shortens
in length as a result, as shown in FIG. 8B. Shortening of the
braided portion results in an overall shortening of the entire
suture. The core material can comprise a hydrogel or other suitable
swellable material.
[0120] In some embodiments, a shrinkable suture comprises a
bioabsorbable core, surrounded by a shape memory or other form of
bias member. When placed in the patient, the bioabsorbable core 35
is absorbed over time. As the bioabsorbable core is absorbed it
will weaken, with the result being that the force generated by the
bias member, will dominate the biomechanical property of the
suture.
[0121] In some embodiments, an example of which is shown in FIG. 9,
the shrinkable suture 80 is configured to shrink in response to an
activation energy or signal. In one case, a shrinkable suture
comprises a shrinkable core 35 that heals into the tissue into
which the suture is placed. In some embodiments, the shrinkable
core 35 comprises collagen. The shrinkable suture 80 further
comprises a energy transfer member 85 for delivering energy to the
shrinkable core 35. In some embodiments, the energy transfer member
85 comprises a wire that can be heated by RF energy, or via a
directly applied electrical current. Upon heating, the wire
transfers energy to the shrinkable core 35, which in turn results
in heating of the shrinkable core 35. In response to the thermal
energy, the shrinkable core 35 in turn shrinks, creating tension in
the tissue into which the shrinkable suture 80 is embedded. In the
case of a shrinkable core comprised of an unfixed tissue, a
temperature of 42.degree. C. can be effective to result in
shrinkage. In some applications it can also be desirable to cool
the tissue immediately after the heat shrinkage step in order to
minimize damage to surrounding tissue.
[0122] In some embodiments of a shrinkable suture, the suture
comprises a first material 185 having a relaxed length and a
deformed length, where the deformed length is longer that the
relaxed length. In some cases the deformed length is 10-30% greater
than the relaxed length. In some embodiments, the suture is
extended to its deformed length, and that configuration held by a
second material 135 that resists relaxation. Conveniently, the
second material 135 can be biodegradable, such that when the suture
is placed in the body, the second material is absorbed over time.
Once enough of the second material has been absorbed, the first
material 185 assumes its relaxed length, and the suture
shortens.
[0123] In some embodiments, the first material can comprise Nitinol
or any other suitably elastic material, as shown in FIG. 9. In some
embodiments the first material 185 can comprise a shape memory
material, that can be activated after a period of time to assume a
memorized length, that results in shortening of the suture, or an
increase in tension imparted by the suture on the surrounding
tissue. Activation can be performed after a period of time
sufficient for the second material 135 to be absorbed by the
body.
Tissue Ingrowth
[0124] Healing typically occurs in three stages: inflammation,
tissue formation, and matrix formation and remodeling. Matrix
formation and remodeling can persist for as long as 6-12 months
after wounding. Sutures used for temporarily holding tissues
together are generally designed to minimize inflammation. Sutures
designed to support tissue, such as those used in plastic surgery
lift procedures, should also encourage tissue ingrowth, so that
eventually the suture is further supported by a column of native
collagen-containing scar tissue.
[0125] A variety of methods can be used to promote tissue ingrowth.
When sutures made from naturally occurring material are used, this
can include, methods of fixation of the suture material(s). For
example, glutaraldehyde, EDC or epoxy fixatives result in sutures
with more tissue ingrowth potential than do other fixatives. Where
synthetic suture materials are used, braiding can be used to
enhance tissue ingrowth. In some cases, synthetic materials can be
manufactured such that they are porous. Implants with porosity
greater than about 50 to 75 .mu.m will generally permit tissue
infiltration and vasculariztion. Porosity can be varied the
construction of the suture, for example by providing a
multifilament suture with a loose braid, or with twisted
filaments.
Absorbability
[0126] All embodiments described herein can be fashioned from
bioabsorbable materials. Materials can include those from natural
sources such as gut, and other like materials, or synthetic
materials. A variety of polymers can be used to produce
bioabsorbable sutures including, without limitation, poly(glycolic
acid), poly(glactin), poly(para-dioxanone),
poly(trimethylenecarbonate), or poly(caprolactone). Different
combinations of materials can be used to produce sutures that
display different rates of absorption in vivo. In some embodiments,
sutures can comprise both absorbable and non-absorbable
materials.
Preventing "Cheese-Wire" Effect
[0127] For supporting tissues, especially larger masses of tissue,
such as the breast or buttocks, some embodiments can be designed to
prevent what is known as the "cheese-wire" effect; i.e., cutting
through tissue by the suture or support member due to movement of
the suture or support relative to the adjacent tissue.
Cheese-wiring is particularly evident when using very thin sutures,
or ones with abrasive surfaces. In some embodiments, using a suture
made from a natural material can be effective to reduce the
cheese-wire effect, due to their relatively large cross section and
smooth surface, and because they better heal into the surrounding
tissue.
[0128] In some embodiments, a suture or a support system can
comprise a region with a wide cross section 90 in at least one
direction, as shown in FIGS. 10A and B. Thinner ends 95 can be
provided to improve ease of securing the suture in place in the
patient. In some embodiments, the suture can be configured as a
thin-walled tube, analogous to an angioplasty balloon.
[0129] The suture can be folded down into other configurations. For
example, a folded suture 100 can be produced by drawing the
unfolded suture, shown in FIG. 11A, through a folding die, as in
FIG. 11B. Once the suture is placed in a desired position, it can
be configured to assume a shape that provides a wider support area
effective to support tissue, while limiting the extent to which the
suture will cut into the tissue. In one method, the folded suture
100 shown in FIG. 11B is expanded to form an inflated or expanded
suture 110, shown in FIG. 11C, which is then deflated in order to
provide a flattened suture 120, shown in FIG. 11D.
[0130] The suture can optionally include supports 130 running
either internally or externally, to provide additional tensile
strength, as shown in FIG. 12A. In some embodiments, the supports
comprises wires running along the longitudinal axis of the suture.
Other supporting elements other than wires can also be used.
[0131] A suture with supports 130 can be reconfigured as described
above. For example, as with the suture shown in FIG. 11, a portion
of a supported suture can comprise an inflatable region. As above,
the suture 90 can be folded 100, by drawing through a folding die,
as in FIG. 12B. The folded suture can be expanded 110, as in FIG.
12C, and then flattened 120, as in FIG. 12D.
[0132] In some embodiments, the device can be inflated with an
inflation media. In some embodiments, the inflation media can be
removed and the device deflated, or the inflation media can remain,
in which case the device remains inflated. In some embodiments, the
device can be inflated with a fluid (i.e., gas or liquid) that
later changes viscosity, converts to a gel, or solidifies. In some
embodiments, the device can be expanded mechanically by use of a
dilation tool. The dilation tool, in some embodiments, comprises a
wire or plurality of wires that can also be used to form the device
into the flattened configuration 120.
[0133] In some embodiments, wires 140 are connected to opposite
ends, of a braided section 40, as shown in FIG. 13. Tensioning 145
of the wires will result in shortening and widening of the braided
region, resulting in a wider support area.
[0134] In some embodiments, an expandable suture can be fashioned
from a small-diameter, expandable tube. In some embodiments, a
second suture passes through the lumen of the tubular suture, and
is attached to a plug having a significantly larger diameter than
the inner diameter of the tubular suture. Once the tubular suture
is in place in the patient, the plug is drawn through the tubular
suture, resulting in expansion of the tubular suture diameter. In
some embodiments, the tubular suture diameter can be expanded by
500%. By optimizing the wall thickness of the tubular suture, the
suture once expanded, will tend to assume a flattened
configuration.
[0135] In some embodiments, a suture can be expanded with a heated
fluid. Increasing the temperature of the suture can provide several
advantages, including, and without limitation, allowing easier
expansion of the suture, accelerating tissue-ingrowth, and inducing
shrinkage of collagen in the region surrounding the suture.
[0136] In some embodiments, a suture 150 is provided as a flat
strip of material, which can then be rolled up into a smaller
diameter for easier insertion into the patient, as shown in FIGS.
14A and B. After insertion, the suture can be unrolled back to the
flattened configuration to provide more effective tissue support.
In some embodiments, at least the flat portion of the suture
comprises a shape memory material, such that it spontaneously
assumes a flattened configuration upon release from a delivery
device, for example a sheath, specialized needle, or trocar.
[0137] In some embodiments, a suture can comprise a plurality of
wires 170 coupled to either an anchor point, or a gathering point
175 short of an anchor point, as shown in FIG. 15. Providing a
multiplicity of wires effectively spread out the weight of the
tissue being support, thereby reducing the tendency for a single
wire to cut into tissue.
[0138] In delivering embodiments of a suture as described herein,
the suture 10 can be provided attached to a needle 180, or inserted
inside a protective delivery sheath 190, as shown in FIG. 16A.
Delivery of a barbed suture inside a trocar, sheath, or catheter,
for example, allows efficient delivery of the suture regardless of
the orientation of barbs. In some designs, delivery of barbed
sutures by needle required that the barbs be oriented such that the
suture can glide into the tissue into which it is inserted (i.e.,
the barbs face away from the direction of insertion). These designs
also require that the skin be punctured a second time in order to
access the implanted needle, so that it can be trimmed from the
suture and removed following suture placement.
[0139] In embodiments of the present disclosure where the suture
can be delivered within a trocar or sheath, some techniques permit
delivery of the suture with only a single skin puncture. This can
reduce the risk of complications due to infection, reduce the
amount of pain involved in a procedure, and allow for more rapid
recovery of the patient. In addition, use of a the delivery sheath
can prevent engagement of the tissue by the barbs until the sheath
is removed, as so sutures with bidirectionally oriented barbs 200
can be easily delivered.
[0140] For example, with current sutures, performing a facelift
procedure requires sutures enter near the hair line and exit
through the cheek near the nasolabial fold. After the procedure,
the patient is left with sutures that protrude from the face, which
is aesthetically unappealing. In response, the suture ends are
trimmed such that they lie just below the surface of the skin. In
some case, however, the ends can erode through and reappear on
above the surface of the skin. Trocar or sheath delivery avoids
these problems.
[0141] In some embodiments, one of which is shown in FIG. 16C, a
delivery sheath 210 for a suture 10 includes a small opening
through which a portion of the suture can protrude. A region at or
near the tip of the suture can comprise a barbed end 220. During
placement of the suture, the suture can be substantially fully
enclosed within the sheath, such that the barbs do not grasp tissue
while the sheath and suture are being advanced, as shown in FIG.
16C. After the suture end is in a desired location, the barbed end
220 of the suture 10 can be advanced out of the sheath 210,
allowing the barbs to engage adjacent tissue 225. Once engaged, the
barbs will effectively anchor the end of the suture substantially
in place, while the sheath is withdrawn, exposing the remainder of
the suture, as shown in FIG. 16D. The suture can include additional
barbs 20 in addition to those located at or near the end, to
further anchor the suture in place once the delivery sheath has
been removed.
[0142] In some embodiments, a trocar 240 that is open at both ends
240 can be provided to deliver the suture 10. A barbed suture can
be passed through the trocar, the barbs oriented so that the
suture, once exposed to adjacent tissue, resists movement relative
to the trocar. In some embodiments, a length of the barbed suture
extends out from the end of the trocar, as shown in FIG. 16E. The
length of suture extending from the suture can be from about 0.5 cm
to about 5 cm, although this is not considered limiting. Pushing on
the trocar results in the exposed portion of the suture doubling
back on itself, such that the barbs will engage the adjacent
tissue, as shown in FIG. 16E. Once the end of the suture is set in
place, the trocar can be withdrawn, leaving the suture in place.
Tensioning can be performed in a similar manner as that used with
other barbed suture embodiments described herein.
[0143] The distal end of the trocar can be cut at an angle or
ground such that the end of the trocar forms a point, while
providing room for bending of the suture. In an exemplary
embodiment, a trocar has a 0.5 mm OD and a 0.3 mm ID, and is about
225 mm long. A suture of slightly less than 0.3 mm diameter fits
easily within the trocar.
[0144] In some embodiments, coaxial arrangement of a support
material surrounding the suture can be used to improve pushability
of the suture, as shown in FIG. 16F. The support member 250 can be
coupled to the proximal end of the suture to aid in delivering the
suture with a pushing force. After delivery, cutting the end of the
suture distal of the coupling would release the support from the
suture, and allow withdrawal of the support and trocar, leaving the
suture in place. The support member can be made from a variety of
materials including, without limitation, Nitinol, surgical steel,
or polymers such as PEEK, polyimide, polyethylene, polypropylene,
or composite material suitable for use in medical devices such as
catheters.
[0145] In some embodiments, the delivery system includes a
multi-part needle, as shown in FIG. 17A-D. In some embodiments, the
needle has two components, a needle 260 having a first radius of
curvature, and a hypodermic tube 270 having a second radius of
curvature. The first radius will be greater than the second radius.
For example, the first radius of curvature of the needle can be 5
cm, while the radius of curvature of the tube can be 15 cm. The
needle and tube are coaxially arranged such that the needle is
slidably held within the tube.
[0146] In using this system, the surgeon can continually alter the
path of the suture by simply regulating how much of the needle 260
is held within the hypodermic tube 270. Where less of the needle is
within the tube, the radius of curvature will be dominated by the
shape of the tube and have, in this example a radius of 15 cm.
Where more of the needle is within the tube, the needle will force
the tube to take on a shape with a smaller radius, and thus follow
a track of smaller radius, for example a radius of 5 cm. Thus, the
surgeon can advance a suture over a more or less curved path, as
shown in FIGS. 17C and D.
[0147] It will be readily understood that the radii recited above
are provided only as examples, and various combinations of needles
and tubes with varying radii can be used. In addition, the system
can include a needle and a plurality of tubes, such that the device
could be telescoped in order to provide even finer control of the
suture path through tissue.
[0148] Coaxial, multiaxial, steerable designs can also be applied
to the trocars and catheters as described above. In addition, the
systems can also include guide wires that the trocar or catheter
passes over. Guide wires can include a needle tip and be steerable,
providing an even smaller radius pathway through tissue.
[0149] To aid the physician in placing sutures, the suture can
include identifiers to mark barbed regions, or the length of the
suture contained within a trocar, for example. In one embodiment,
the suture is color coded with a particular color indicating a
barbed region, while a different color can be used to indicate a
non-barbed region. In some embodiments, other colors or marking can
be used to indicate regions with distinctive mechanical properties.
For example, and without being limiting, a third color can be used
to indicate a region of increased elasticity.
[0150] During the surgical procedure, visualization can be
accomplished by direct or indirect methods, including ultrasound,
MRI, CT, or using an endoscopic tool and camera combination, among
other imaging modalities. Sutures, needles, and trocars, can
include markers as are known in the art for visualization when
using radiographic imaging modalities. Such markers can be made,
without limitation, from metals such as gold, platinum, stainless
steel, and other suitable metallic alloys or even non-metallic
materials. Such markers can be included during the manufacturing
process.
[0151] An advantage provided by some suture embodiments, as
described herein, is the ability to adjust or re-tension the suture
after placement. Adjustment permits the surgeon to maintain a
particular tissue configuration and appearance over time. In some
cases, such as where the suture does not include barbs, or where
the suture does not protrude through the skin and is therefore
relatively inaccessible, an additional adjustment mechanism can be
included with the suture, in order to provide a way in which to
vary tension of the suture during the course of the healing
process, and even afterward.
[0152] In some embodiments, the adjustment mechanism comprises a
knot and a ratchet mechanism. In some embodiments, the adjustment
mechanism can comprise a tang in a groove, analogous to a zip tie
device. Where possible, embodiments comprising a knot are designed
to be low-profile, such that the adjuster does not produce a bump,
or erode through the skin.
[0153] In some embodiments, the ends of a single suture, or the
ends of two separate sutures, can be joined by a linking device,
where a first end is a tube 290, and a second end has a
substantially round cross-section 300, as shown in FIG. 18. The
second end is inserted into the tubular section of the first end. A
skived area near the first end allows the second end to
protrude.
[0154] A variety of methods of securing the first and second ends
can be used. In some embodiments the ends can be secured by an
adhesive that is cured in response to heat, pressure, moisture, or
a chemical catalyst. In some embodiments, the tubular section can
be made to be shrinkable, or alternatively be made from a shape
memory material. In some embodiments, the second ends includes
barbs that engage the first end, or a feature on the first end such
as a pocket. In some embodiments the barbs can be on the first end,
in the lumen of the tubular portion, and engage the second end
which can be barbed or not. The second end can further comprise a
textured surface, or multiple regions of varying diameter to better
engage the first end. In some embodiments, a tubular section
engages two separate sutures having substantially round cross
sections. In some embodiments, the tubular connector section can be
deformable, and will adapt to the cross-sectional shapes of the
sutures to be joined. Conveniently, the tubular member 290 can
include an anchor 294, for securing the joining device in place in
the patient. A suture end can also include an anchor 292.
[0155] A number of embodiments of the present disclosure are
compatible for use in performing breast lift procedures. In some
embodiments, the support member can be composed of Proline.TM., a
non-elastic polymer line. The support member can be placed
underneath the breast tissue, and secured by means of a knot or a
fastener to a body landmark such as a tendon, bone, or the like. As
described above, the system can include suspension members that are
either elastic or non-elastic. The system can further include a
safety disconnect, permitting the suspension members to release
when under an increased load, in order to prevent damage to the
breast tissue by the support system.
Use in Breast Procedures
[0156] In some embodiments, sutures of the present disclosure are
used to perform a minimally invasive breast lift, as shown in FIG.
19. In one method, suspension members 330 are inserted through the
skin and advanced at a depth of between about 2.5 and 25 mm under
the skin surface. The suture is passed through the Cooper's
ligaments and fatty tissue. One or more loops of suture material
are looped under the breast 320, and suture ends are attached to an
area in the chest 342, serving as anchor points for the suspension
members 330. The sutures are tensioned in order to simulate support
provided by natural, healthy Cooper's ligaments, as shown in FIGS.
19 and 20, and are effective to lift the breast 320 (compare left
and right panels in FIG. 19).
[0157] In some embodiments, the attachment to the chest areas
comprises a loop of suture material threaded around a portion of
the pectoral muscle, fascia, sternum, a rib, or a ligament, or
combinations thereof. The loop is inserted through the skin with a
small caliber needle, and positioned below the top edge of the
breast, so that the suture support is not visible through the skin.
A curved needle attached to the suture can be used to insert the
suture material. In some embodiments, the needle comprises two
parts that are axially movable relative to each other, and which
have different curvatures, such that the surgeon can adjust the
curvature of the needle is it is being inserted. In some
embodiments, the suture is delivered within a sheath.
[0158] In some embodiments, the anchor can comprise a bone screw,
attached to bone or cartilage in the sternum or rib cage.
[0159] In some embodiments, a suture 330 can run from the anchor
point 342, along one side of the breast 320, under the breast, and
up the other side back to the anchor point 342. A number of sutures
330 placed in this way will be effective to cradle and lift the
breast from below. In some embodiments the sutures 330 could run
down either side of the breast and attach at support points 340
either under or to one side of the breast. A number of possible
ways of placing and orienting sutures will be possible in achieving
lifting of the breast while maintaining breast symmetry and
aesthetic appearance. These various arrangements and combinations
will be apparent to those of skill in the art.
[0160] In some embodiments, the suture lines can be extended
transcutaneously around the nipple area to preferentially
reposition this portion of the breast. This corrects the situation
where the nipple turns downwards in response to age or as a result
of breastfeeding. Looping a suture line around the nipple provides
for support of the nipple, without having to support the entire
weight of the breast. Where a nipple repositioning technique is
used, the suture can be anchored using the methods as described
above.
[0161] In some embodiments, lifting of the pectoral muscle is used
to adjust the physical appearance of the breast. A method to modify
the muscle tissue by shortening it can comprise cutting the muscle
and drawing it together, or drawing it together using a series of
threads similar to a corset. Lacing the tissue together results in
lifting of the breast tissue resulting in a more youthful
appearance, and a reduction in breast ptosis.
[0162] In some embodiments, shortening of the muscle fibers is
accomplished by internal anchors deployed into the muscle fibers.
Drawing the anchors together in turn draws the muscle tissue
together. The anchors can be connected by suspension members
comprising elastic or inelastic materials. Elastic material can be
used to allow for normal loading conditions such as physical
movement and activity. Additionally, elastic materials can result
in further lifting of the breast tissue.
[0163] Elastic material examples can include, without limitation,
silicone core braided materials similar to a "shock cord"
construction, polypropylene mesh as used in hernia mesh, NiTi alloy
wires or braids, coiled type springs, and similar materials and
combinations known in the art. In some embodiments the materials
distribute the entire load throughout the length of the suspension
line limiting longitudinal movement. In some embodiments, the
suture lines comprise relatively inelastic materials including,
without limitation, polypropylene suture, NiTi wire, stainless
steel wire, polypropylene mesh and the like. These materials can be
attached to anchors such as barbs, hooks, flared materials such as
NiTi elements and the like.
[0164] This system can be foreshortened during initial implantation
or post implantation with mechanisms such as, and without
limitation, screws, loops, cams and rotary pulleys, or any other
means effective to shorten thread or wire-like elements. The muscle
can be additionally suspended by hernia mesh material and tied to
land marks such as, without limitation, bone, fascia, tendon, and
other areas that would bear the loading conditions. In some
embodiments an exemplary diameter of a suspension line can range
from about 0.005 inches to about 0.090 inches. In some embodiments
the diameter of a suspension line would be about 0.030 inches.
[0165] In some embodiments the material permits tissue ingrowth,
and thus moves with the native tissue, reducing irritation and
cutting of the tissue. The material can be coated with a
therapeutic agent to enhance tissue ingrowth, and in some
embodiments the suture material is manufactured to include the
therapeutic agent. In some embodiments, the therapeutic agent is
added just prior to implantation, either by impregnation, by
coating, or by a combination of the two processes.
[0166] In some embodiments, coatings or treatments can include a
inhibitory agent to limit or prevent tissue ingrowth such that the
material will not adhere to the surrounding tissue. In some
embodiments a suspension line runs through a cylinder of fluid that
allows movement between the suspension line and the tissue.
[0167] In some embodiments the support system comprises suspension
members 330 are provided that are oriented in a substantially
vertical orientation, as shown in FIG. 21, and attach to an anchor
point 340 above the breast. The support members 360 are coupled to
the suture lines 330. In some embodiments, angles for suspension
members other than vertical are used to customize the shape of the
breast or where the procedure is used to correct breast
asymmetries. As shown in FIG. 22, angled suture lines 380 can
provide lifting or additional lateral adjustment, in addition to
what can be provided using vertically oriented suspension members.
For example, by placing the support lines angled either to the
right or left of vertical, the nipple and/or breast may be adjusted
medially or laterally as desired by the surgeon, in addition to
vertical repositioning. In some embodiments, a vertical support
line and secondary tensioning line can be used, and the vertical
lines can thus be pulled laterally, redirecting the force vector
supporting the breast tissue. In some embodiments, it can be useful
to provide laterally oriented suspension members alone, such as
where lateral repositioning is required, but lifting is not desired
or otherwise indicated.
[0168] In some embodiments, the support system comprises components
with non-linear elastic constants (e.g., a secondary elastiomer to
increase the load bearing at the bottom of the stroke). This allows
for normal support while standing, and provides additional load
bearing capacity during activities such as walking. running, and
jumping. In some embodiments, components that allow for complex
loading are designed using larger cross sectional areas or by
providing components fashioned from more than one material, where
the individual materials have distinct elongation characteristics.
In some embodiments first 400 and/or second 410 elastic components
can be used to provide more complex mechanical behavior, as shown
in FIG. 23. In some embodiments, the first and/or second elastic
components can comprise springs. In some embodiments, the first and
second elastic components can have the same or different elastic
constants. In some embodiments, the first and/or second elastic
components can be positioned anywhere along the length of a
suspension member.
Safety Disconnect
[0169] In some embodiments, a safety release 390, shown in FIG. 23,
provides a mechanism to protect the attachment area or the
supported tissue from damage caused by support system components
when large loads are imposed on the tissue and/or the support
system. For example, excessive load can occur during excessive
motion or concurrent with a trauma. The safety release 390 is
designed to separate the support member 360 from the suspension
members upon exceeding a defined loading.
[0170] In some embodiments, the safety release 390 comprises a
region engineered to fail at a predetermined limit. In some
embodiments the mechanism comprises a necked section to allow for
yielding. In some embodiments, a slip disconnection that decouples,
or a joint that unlatches can be examples of effective safety
releases. In some cases the safety release mechanism can be
designed such that it can be reconnected or repaired following
release. The loading limit effective to result in release of the
suspension members from the support member can range, for example,
from about 0.5 kg to about 8 kg, and in particular from about 1 kg
to about 3 kg of force.
[0171] In some embodiments, selecting the elastic characteristics
of the support member to carry partial or complete loading can
allow for a least amount of tissue movement relative to the
suspension element. In some embodiments, the entire length of the
support system can assume the stress where the least amount of
movement is shared throughout the entire system. Continuous length
elastic elements 420 can be used to support the loading to lessen
the stress concentrations in one area of the implant, as shown in
FIG. 24. In some embodiments, the system can also include an
adjustment mechanism 350, useful to vary the tension exerted on the
tissue by the support system either at the time of implantation, or
later once the healing process is complete or near complete.
Adjustments could also be made over extended times in order to
maintain the supported tissue in a desired position.
Support Member with Inflation Pleats
[0172] In some embodiments, the support member can include
additional load carrying or shock absorption capability. For
example, hydraulic (gas or liquid) elements can provide a resilient
cushion in order to compensate for various loading conditions, such
as jogging and other sporting activities, or to absorb some of the
effects of trauma. In some embodiments, shock absorption is
provided by a support member comprising inflation chambers 430. The
chambers can be configured to compress during heavy loading, with
compression providing the resiliency to return the device to a
pre-loading configuration once the activity or other source of
loading has ended. Similarly, the system can include a charged
system, analogous to an automotive shock absorber, to dampen
loading, and where the charge would allow for recoil loading.
[0173] The chambers can have a wall thickness in a range, for
example, from about 5 .mu.m to about 250 .mu.m, depending upon the
material, the inflation pressure to be used, and the degree of
resiliency desired. There can be a single chamber or multiple
chambers. Material choice, chamber wall thickness, and/or inflation
pressure can provide customized mechanical properties to support
members. In some embodiments, the length of the chambers ranges
from about 5 cm to about 15 cm, and width ranges from 0.5 cm to
about 4.0 cm. In some embodiments, the length of the inflation
chamber is about 10 cm, and the width is about 3 cm. Precise shapes
and dimension can be varied depending on the particular anatomical
makeup of the patient, or on the kind of support or aesthetic
results desired.
[0174] In some embodiments, the chamber(s) can be filled with a
media that solidifies or gels. In some cases, the media remains in
a liquid form. Composition of the media can include, without
limitation, silicone, saline, epoxy, and any other safe implantable
fluids, solids, or gases that will be substantially retained within
the chamber(s).
[0175] In some embodiments, addition of one or more volume elements
supported by suspension elements can be used to augment low volume
breast tissue and enhance the final outcome with respect to a
patient's fullness. The volume element can comprise a prior art
augmentation device such as a silicone or saline implant or it can
use a dermal filler to soften the look of the breast. In some
embodiments, support members comprising chambers 430, an example of
which is illustrated in FIG. 25, can be adapted to provide volume
enhancement. Fillers can include, without limitation, commercially
available materials such as Radiance, Juvederm.TM. or other
suitable filler materials. Additionally, the patient own cells or
other tissue could be used to offset the decrease or need for
additional filling. These cells could be harvested and replaced or
harvested and processed by centrifuging or filtering to collect
cells suitable for implantation.
[0176] In some embodiments, different connection points for
suspension and support members can be used to adjust the position
of each breast separately, or to allow shape changes that improve
the cosmetic appearance of the breasts, for example to provide
symmetry.
Folded Support Member For Easier Insertion
[0177] As described above, in some embodiments the support system
is folded prior to delivery. Folding reduces the device profile,
such that a smaller incisions can be used to provide an entry point
when introducing a support suture or system into the body. The
smaller incision in turn limits the size of the scar resulting from
the implant procedure. A number of manipulations well known in the
art including, without limitation, rolling, folding and twisting of
the support member, can be used to reduce the device profile prior
to delivery.
[0178] Post insertion the mesh support member can opened and
flattened for final placement. In some embodiments, the unfolding
process is performed using specialized instruments, such as a small
tool 440 in similar in shape to a "hockey stick" as shown in FIG.
26. Spoon shaped tools are also effectively used to unfold and
place the device in the desired location.
Support System Including Barbed Elements
[0179] In some embodiments, the support member 360, the suspension
members, or both, can comprise engagement members, for example,
barbs 20, as shown in FIG. 27. Barbs are effective to improve
engagement of the adjacent tissue and reduce movement of the
support system relative to the tissue. Barbs can be fashioned from
materials similar to those used to construct the support member or
suspension members, including, without limitation, stainless steel,
Nitinol and any other biocompatible materials.
[0180] In some embodiments, the barbs can be from about 0.25 mm to
about 2 mm in diameter, and from about 0.25 mm to about 5 mm in
length. In some embodiments the barbs are 0.5 mm in diameter, and
about 2.5 mm in length. These are examples of barb dimensions and
other dimension of barbs can be used without limitation. Barbs can
be oriented all in the same direction or they can be oriented in
alternate directions in order to provide resistance to both
proximal and distal movement.
Other Suspension Elements
[0181] In some embodiments, the device can comprise a nipple
suspension element 450 to raise the nipple and/or reposition it
with respect to the support members, as shown in FIG. 28.
Positioning the nipple using a separate element allows for separate
positioning of the breast relative to the nipple. Including
addition suspension or tensioning elements provides the ability to
make vertical and/or horizontal adjustments to the nipple.
Additional Support System Components
[0182] In some embodiments, the support system can comprise a
webbed, or mesh, support member 360, suspension members 330, and
attached needles 260 for insertion into the patient, as shown in
FIGS. 29A and B. In some embodiments, the suspension members and
support members can comprise a contiguous structure. In some
embodiments, the suspension members and support member can comprise
separate pieces that are assembled prior to use.
[0183] Conveniently, in some embodiments, the support member can be
fashioned in the shape of a sling or hammock, an example of which
is shown in FIG. 29B. As used herein, the term "sling" or "hammock"
is intended to include, without limitation, a wide variety of
shapes and sizes, materials and treatments. A sling (or hammock)
can be rectangular, other shapes are also contemplated included
oval, circular, elliptical, and tear drop shaped. In some
embodiments, the sling can be made of a mesh material. The mesh
material can comprise one or more woven or inter-linked filaments
or fibers that form multiple fiber junctions throughout the mesh.
The fiber junctions can be formed via weaving, bonding, ultrasonic
welding or other junction forming techniques, and combinations
thereof.
[0184] In addition to suspension members and a support member, a
support system can comprise additional components. For example,
channels 460 can be used to hide the wire or springs 470, which can
be effective to eliminate irritation to the surrounding tissue, as
shown in FIG. 30. These channels may be open or closed to either
allow or limit contact with body fluids. In some embodiments, the
channel may utilize a perforated channel to allow fluid to flow or
move within or around a wire or spring. In some embodiments, fluids
in channels can serve as a lubricant for suspension members within
channels.
[0185] Where multiple support members are used, separation of the
elements can be provided, as shown in FIG. 31, by separators 480.
One or more separators 480 between support members 360 can be
effective to limit motion of support members relative to each
other. Separators can resist movement of elements toward or away
from each other by geometric column strength or tensile stress,
respectively. In some embodiments, separators 480 can be measure
about 0.25 mm to about 2.5 mm in diameter with a length of 0.5 mm
to about 8 mm. It will be understood that these dimensions are
exemplary only, and other dimensions of separators can be
successfully used. A variety of materials can be used to make
separators, including without limitation, plastics, polymers,
metals, and these materials can be permanent or absorbable.
[0186] Maintaining a defined separation of support members during
or post implantation provides for more even suspension of tissue
with loading distributed across the effective area encompassed by
the support member(s). Embodiments of support members can be
provided as a mesh material with different patterns depending on
the loading or stress expected. Additionally, support members can
be fashioned with a preset shape effective to resist collapse when
the ends are tensioned as during loading.
[0187] A wire mesh work made from NiTi or stainless steel can allow
for a flatter looking implant during loading, whereas a limp thread
element may provide little support on the sides of the breast when
loaded. This allows for a rounder shape definition rather than
squeezing at each side of the breast during loading. The wire
elements can be pre-shaped and memory set to allow for normal
motion and tissue manipulation.
[0188] For example, as shown in FIG. 32A, a wire support 490
included in the support member 360 mesh can increase strength and
provide means for coupling the support member to other components
of the system. By adding additional components to the support
member, properties of strength or elasticity can be imparted,
depending on the choice of materials, for example, and without
being limiting, elastomers, pre-shaped shape memory elements,
springs and the like. These additional elements can be located
above or below the mesh or embedded into the mesh for motion
encapsulation. FIG. 32B illustrates an embodiment of a wire support
490, separated from the support member 360.
Insertion Method
[0189] In some embodiments, there is also provided a method of
insertion of the device, as shown in FIG. 33A-F. In one embodiment,
insertion is performed by a needle 260 inserted at the base of the
breast 320, exiting the other side of the base, and pulling the
support member 360 through the tissue between the glandular
structure and the subcutaneous fat (FIG. 33A). Once the support
member 360 is positioned correctly, the needle 260 can be passed
back into the same needle hole and vertically to the anchoring
position (FIG. 33B). As the needle is passed back into the fascia
of the pectoral muscle, the piercing of the fascia is captured and
the needle is once again pulled out of the transcutaneous needle
hole (FIG. 33C). In the same fashion the other support line can be
passed and the fascia again can be captured and tied to the other
support member where a knot pusher can be used to slide the knot
345 deep beneath the skin where it can be hidden to avoid producing
a bump that might otherwise show on the surface of the skin (FIG.
33D). Anchoring of the support system can be achieved by looping or
otherwise tying the ends of the suspension members to a suitable
anatomical feature, such as a bone 500, for example (FIGS. 33E
& F).
[0190] Some embodiments of a method of insertion of support system
include an initial pathway being introduced under the skin with a
guidewire system, and providing a tubular sheath for guidance,
along with the ability to exchange wires. A tubular sheath allows
the surgeon to maintain access to a common pathway for device
installation and manipulation. The guidewire can be introduced
under the skin through a small trocar or needle where the softer
tubular sheath is exchanged out, and other elements can be passed
through such as thread, suspension elements, and the like. A larger
incision at the lower portion of the breast can be used to
introduce a wider support member, for example a sling or hammock as
has been described herein. This can include an incision to
introduce the wide sling at one or both sides of the breast.
Additionally, these techniques could be all completed in an open
procedure as normally seen in a mastopexy operation.
Additional Exemplary Procedures
[0191] Embodiments of sutures as presently disclosed can be used to
resuspend loose tissue in the neck region. A suture can be inserted
using a similar technique as that used for a breast lift. The
suture can also be configured to spread out support over multiple
lines, or using slings or other types of configurations as
described above, so as to prevent the cheese wiring effect that can
occur when using a single thin-lined sutures. Designs applicable
for use in breast lift procedures, are thus equally applicable for
use in a neck lift procedure.
[0192] As shown in FIG. 34, in one method, the suture 510 is
inserted under the skin surface and advanced below the surface
following a line extending along the crease in the skin where the
underside of the jaw area meets the neck. In some embodiments of a
neck lift method, the upper portion of the suture 510 is turned
upward and extended posteriorly to the jaw bone. The suture can be
anchored 340 with a loop of suture material to the connective
tissue located behind the jaw bone and just below the ear.
[0193] Embodiments of barbed sutures can be used effectively to
lift tissue in the lower thigh area that has sagged down above the
knee, as can occur during aging. Sutures with barbs at either end
can be inserted from above the skirt line and used to pull the skin
from the lower thigh up towards the tissue in the upper thigh area.
The barbs located in the part of the suture located in the upper
thigh region can be anchored to the dermis, or to tendons,
ligaments, bone, or muscle, further below the surface. The portion
of the suture located in the lower thigh area can engage the dermis
or fascia, or other tissue, typically at a depth of 0.2 to 20 mm
below the skin surface. A method similar to that used to lift thigh
tissue can be used in the region of the upper arm.
[0194] Embodiments comprising barbed sutures can also be used to
engage muscle. For example, in some embodiments, sutures can be
placed in the abdominal region, and then tensioned to pull the
abdominal muscles back into position. In some embodiments, the
method can further providing a support system comprising a series
of tabs 530 and sutures 540. In these embodiments, additional
tension canto be applied to the sutures, while at the same time
avoiding pulling the suture through or otherwise tearing the tissue
to which they are attached, or through which they have been
threaded. By weaving a series of line from one tab to the other,
the muscles can be further supported, for example as illustrated in
FIG. 35. The tabs can be inserted by a small incision, and placed
under the skin. Suture material can be pre-loaded into each tab,
and sutures connected to each other by a transcutaneous knot or
series of knots.
[0195] As shown in FIG. 36, embodiments comprising barbed sutures
can also be used to improve upon prior art methods of performing
facelift procedures. In the prior art methods, shown in FIG. 36A,
sutures 550 are inserted under the skin near the front of the
cheek, pass up towards the hairline, where they exit out of the
skin. This method leaves exposed suture ends 560 near the front of
the face, which are unsightly. Although these ends can be trimmed
such that the ends lie under the surface of the skin, over time it
is possible for these ends to erode through the skin and
reappear.
[0196] In contrast, in some embodiments of the present disclosure,
the suture 550 is fashioned to have barbs at a first end of the
suture. The barbs are effective to engage the tissue and resist
movement (or to create tension) once in place. The first end can be
delivered into the facial area through a trocar. In some methods,
the insertion point of the trocar can be above the hairline. Once
the first end is in the desired position the trocar can be removed
wherein the barbs are exposed to, and ultimately engage, the
surrounding tissue. Tension can be applied to better secure the
barbed end of the suture within the tissue. The suture can
optionally include markings that inform the surgeon how deeply the
suture has been placed. If placement is unsatisfactory, the same
trocar, or a second trocar, can be inserted over the suture to
facilitate removal and/or relocation. The method obviates the need
for an insertion point near the front of the face, and further
avoids having suture ends exposed in the facial region, as occurs
with the prior art method.
[0197] Once the first end is in place, the second end of the suture
can be anchored in the scalp, or other suitable region. The second
end can also include barbs to improve anchoring. To place the
second end, the end can connected to a long needle. The needle can
be inserted through the same hole where the trocar was inserted and
then advanced up the scalp. In some embodiments, the distance is
from about 3 inches to about 7 inches, although this is not
limiting. The suture can be exited through the skin, and
satisfactory tension on the suture can be achieved by pulling on
the exposed end. In some embodiments, the free end near the
hairline can be trimmed to below the surface of the skin. In some
embodiments it can be useful to re-tension the sutures after the
barbed portions have healed into the tissue. In these cases, a
short portion of the second end of the suture can be left
protruding from the scalp to enable the surgeon to access it more
easily at a later date. The end can be covered with a small
adhesive bandage, or with a liquid bandage in order to protect the
end.
[0198] Use of the above described techniques can be useful if
providing lifting for this buttocks region. In the buttocks, single
or multiple support systems can be used. The system can designed to
provide for additional load bearing, while preventing cutting or
tearing of supported tissue during movement associated with normal
activity. One end of the support system can be attached to the
outer hip, while the opposite end can be attached to the upper hip
bone. Anchoring in this way provides that the support can function
effectively under either static or dynamic loading conditions. In
some embodiments, the use of crescent shaped support straps can be
used to accommodate the majority of the tissue to be supported.
Additional branch suspension members can be included to allow for
further lifting and shaping of the tissue. Barbed sutures can be
used to improve anchoring within tissues.
Materials & Construction
[0199] Elements of the support system can comprise a number of
materials including, without limitation, biocompatible polymers
(e.g. ePTFE), intestinal sub-muscosal mesh, tendon, Gore-Tex.RTM.,
and polypropylene. Materials can be monofilament, or multifilament,
and can be braided, woven, or knitted. In some embodiments
materials are absorbable (i.e., biodegradable). In some
embodiments, the materials comprise coatings or other agents that
promote healing, reduce inflammation, or improve
biocompatibility.
[0200] In some embodiments, the use of biological materials can
improve tissue interaction with the device. Where a lack of tissue
ingrowth or vasculariztion is a concern, the materials can be
further modified by perforation, or by other treatments such as
fixation with radiation, glutaraldehyde, heat or
1-ethyl-3-(3-dimethylaminopropyl)-carbodiimide (EDC), to improve
porosity.
[0201] In some embodiments, the mesh material of the support
member, for example a sling or hammock, comprises a flexible,
polypropylene monofilament that resists weakening or degradation
when implanted within a patient. One such material is Marlex.TM..
Other mesh and non-mesh materials, can comprise, but are not
limited to, synthetic biomaterials, allografts, homografts,
heterografts, autologous tissues, materials disclosed in U.S.
provisional application Nos. 60/263,472; 60/281,350; and
60/295,068; the contents of all of which are herein incorporated by
reference in their entireties, synthetic materials (such as
metallics, polymerics, and plastics) and any combinations
thereof.
[0202] In some embodiments, the support member material will result
in minimal or no reaction with body tissues and fluids and
indefinitely retain its particular material characteristics and
mechanical properties. Further, portions or all of the support
member can be configured or fabricated from a material to either
promote or prevent tissue in-growth, or are resorbable.
[0203] In some embodiments, the support member, support member
assembly or portions thereof, can have one or more substances
associated therewith through processes such as coating,
impregnation, or combinations of these processes. Examples of
appropriate substances include, without limitation, drugs,
hormones, antibiotics, antimicrobial substances, dyes, silicone
elastomers, polyurethanes, radiopaque markers, filaments or
substances, anti-bacterial substances, chemicals or agents, and any
combinations thereof.
[0204] The substances can be used to enhance treatment effects,
reduce potential rejection by the body, enhance visualization,
indicate proper orientation, resist infection or other effects. For
example, a dye may be coated on one surface of a component of the
support system. The dye can provide the practitioner/surgeon with a
visual indicator to aid in orienting the support member or
suspension members at the target site within the patient and to
avoid undesirable twists along the length of the system. As another
example, the system may be coated by the process described in U.S.
Pat. Nos. 5,624,704; 5,756,145; 5,853,745; 5,902,283 and 6,162,487;
the entire contents of which being hereby incorporated by
reference.
[0205] It will be apparent to those skilled in the art that varying
geometries for the components of the device will be useful. For
example, certain dimensions of thickness, width, or length will be
recognized as being of particular advantage. In addition,
components that are woven, braided, wide or narrow can also provide
particular support functions.
[0206] For example, as described above, in some embodiments the
support member comprises a "hammock" or "sling" shaped element. A
sling or hammock can be especially useful for supporting glandular
tissues, such as breast tissue. In some embodiments, a hammock with
dimensions of about 7 cm to about 15 cm in length, and about 2 cm
to about 5 cm in width, with a pocket of about 0.5 to about 3 cm,
provides effective tissue support. In some embodiments, a hammock
can have a length of about 10 cm, a width of 2.5 cm and a pocket
depth of about 1 cm. In manufacturing a hammock, the particular
shape can be formed by wrapping the material about a spherical or
elliptical shaped mandrel, followed by heating and cooling the
mandrel to induce the material to conform to the shape of the
mandrel.
[0207] A sling (or hammock) can comprise first and second major
surfaces, a pair of end portions, and a support portion for
placement in a therapeutically effective position relative to a
physiological environment intended to be supported (e.g. the
glandular tissue of the breast). In some embodiments, the sling has
a tension adjustment or control member associated with the sling,
for transferring sling adjustment forces from one portion of the
sling to other portions of the sling such as the ends of a support
portion of the sling. The member affords effective repositioning of
the sling while avoiding undesirable permanent deformation of the
sling.
[0208] The support member can be substantially surrounded by a
protective sheath. The support member, tension control element, and
sheath can be made of biocompatible materials with sufficient
strength and structural integrity to withstand the various forces
exerted upon these components during an implant procedure, and/or
following implantation within a patient. In some embodiments, the
protective sheath is constructed of a material that affords visual
examination of the implantable support member material and that
affords convenient passage of the assembly through tissue of the
patient.
[0209] In some embodiments, a woven mesh with a predetermined pore
or opening size to permit tissue ingrowth can be used. These shape
of the openings is not considered limiting to the scope of the
present disclosure, and square, rectangular, and/or round openings
are useful. In some embodiments the size of the openings can vary,
for example and without limitation, from an area of about 0.1
mm.sup.2 to about 30 mm.sup.2. The arrangement of pores can vary
throughout the device in order to provide some areas with added
porosity, or to provide more support. Some areas can comprise
pores, while in other areas pores can be absent. The device can be
produced from elastic materials, or alternatively can be fashioned
from relatively rigid materials.
[0210] In some embodiments, the mesh-like support member is woven
from a monofilament line. Some monofilament lines are finished with
a smooth surface, while others are roughened during the
manufacturing process. Roughening the surface increases surface
area and thus increases opportunities for tissue ingrowth
throughout the surface interstices.
[0211] Roughening can be accomplished during the extrusion process
where the material is flowing through the extrusion die hot thus
creating a dimpled surface. Other roughening methods include,
without limitation, sanding, grinding, roll forming, laser etching,
chemically etching, and spirally or radially scoring to a
predefined depth with a cutting blade, laser, or other means.
Examples of sanding may use a 5-100 .mu.m grit sand paper pulled
across the material. This drags portions of the material along the
longitudinal axis and leaves behind whiskers or microscopic barbs
that can also be effective to engage the tissue. A similar process
could be used with a grinding wheel. Grinding can be performed in a
radial pattern, a helical pattern, or a combination of patterns.
Roll forming allows for a predetermined shape or pattern to be
pressed into the monofilament, and can be performed either with a
heated roll or at ambient temperatures.
[0212] Laser etching allows for an inline process to be added to
the formation of the monofilament. The laser can be angled or
focused directly perpendicular to the material. Chemical etching
removes material at a predictable random pattern and a predefined
depth based on chemical strength and length of contact with the
material being etched. Other materials can be plasma etched to
create a desired surface finish where a chamber is pumped to a
preset base pressure and gas is introduced and a radio frequency
field is applied to the electrodes of the chamber producing a
glow-discharge plasma.
[0213] Knife scoring allows a partial cut to the material to a
predetermined depth leaving behind a ribbed monofilament material
that will be more flexible and allow tissue ingrowth to the cut
sections. These cuts can also be in a spiral patterning to allow a
continuous cut throughout the material length. This also allows for
tissue ingrowth.
[0214] In some embodiments, partially or completely absorbable
materials are used, such that a component(s) can be absorbed over a
period ranging from about 6 weeks to about 2 years. This allows the
skin and other tissues to retighten and remodel, while otherwise
being supported in a desired position. Other methods are also
useful in remodeling or tightening the skin around the breast
including, without limitation, forced scarring, use of laser, heat,
and the like.
[0215] In some embodiments, the overall dimensions of the support
member assembly, including individual sheath, mesh element and
tension control member, are effective to extend from the upper most
connection point down partially encircling the lower portion of the
breast and back up to the upper most portion of the connection
point, with additional length to account for the imprecision
associated with the range of human anatomy sizes. In some
embodiments, the support member has a length X, width Y and
thickness approximately within the range of 8 cm to 16 cm, 1.0 cm
to 6.0 cm and 0.10 mm to 1.0 mm, respectively. In addition, the
length of the tension control element can be approximately
equivalent to or slightly longer than the length of the support
member to tighten or loosen the sling after it is placed in the
body. Alternative lengths, widths and thicknesses can also be used,
depending on the particular anatomical features of the individual
patient, and the tissue(s) being supported.
[0216] In addition, the size of the resultant openings or pores, in
support members configured as a mesh, can be adapted to allow
tissue in-growth and fixation within surrounding tissue. The
quantity and type of fiber junctions, fiber weave, pattern, and
material type influence various sling properties or
characteristics. Non-mesh sling configurations are also included
within the scope of the invention.
[0217] As an example, and not intended to be limiting, the mesh can
be woven polypropylene monofilament, knitted with a warp tricot.
The stitch count can be 10.+-.1 courses per cm, and 5.+-.1 wales
per cm. In an exemplary mesh, the mesh thickness can be 0.6 mm.
[0218] The support system of the present disclosure is not limited
by the need for additional sutures or other anchoring devices,
although such sutures and devices can be used if desired. The
frictional forces created between the system and patient tissue are
effective to prevent movement and loss of tension once the system
is properly located at the target site. As a result, the system
remains securely in place, even when subjected to various forces
imparted on the tissue as will in the patient during various
activities.
[0219] The system is designed to remain within the body of a
patient as an implant for a predetermined therapeutically effective
amount of time. Implantation can be temporary or permanent. The
system can be non-absorbable, absorbable or resorbable, including
any combinations of these material properties, depending on the
desired treatment. For example, portions of the system may be
constructed of a bioabsorbable material designed to last for a
predetermined period of time within the patient. The general
characteristics of the materials and design used in the system will
withstand the various forces exerted upon it during implantation
(for example, frictional forces associated with tissue resistance)
and after implantation (for example, normal activities, including
walking, running, coughing, sneezing, and other "normal"
activities).
[0220] The system as disclosed can be anchored to a variety of
locations in the body, including, but not limited to fascia,
muscle, bone, ligament, and the like. In addition, an anchor can
further comprise an adjustment device that permits the surgeon to
adjust the tension on the suspension members either at the time of
implantation, or post-implantation. The adjustment device can be a
simple screw-like mechanism, around which an end of the suspension
line is wrapped. Turning the screw in one direction increases the
tension on the line, while turning in the opposite direction
decreases tension. In some embodiments, the tensioner is adjusted
through a small incision using an endoscope or other like
instrument, in combination with a tool designed to turn the
tensioner.
[0221] In some embodiments the suspension members can be anchored
to a single attachment point. In some embodiments multiple
attachment points are used. The elements of the devices can be
elastic, or non-elastic as desired. In some embodiments, a braided
portion overlying an elastomeric portion is used. In some
embodiments, the braided portion is also elastomeric.
[0222] The skilled artisan will recognize the interchangeability of
various features from different embodiments. Similarly, the various
features and steps discussed above, as well as other known
equivalents for each such feature or step, can be mixed and matched
by one of ordinary skill in this art to perform compositions or
methods in accordance with principles described herein. Although
the disclosure has been provided in the context of certain
embodiments and examples, it will be understood by those skilled in
the art that the disclosure extends beyond the specifically
described embodiments to other alternative embodiments and/or uses
and obvious modifications and equivalents thereof. Accordingly, the
disclosure is not intended to be limited by the specific
disclosures of embodiments herein.
* * * * *