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Patent 2671628 Summary

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(12) Patent Application: (11) CA 2671628
(54) English Title: DIFFERENTIATION OF SURGICAL FILAMENTS
(54) French Title: DIFFERENCIATION DE FILAMENTS CHIRURGICAUX
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61B 17/04 (2006.01)
  • A61B 17/03 (2006.01)
  • A61B 17/12 (2006.01)
(72) Inventors :
  • ABUZAINA, FERASS (United States of America)
  • HOTTER, JOSEPH (United States of America)
(73) Owners :
  • TYCO HEALTHCARE GROUP LP (United States of America)
(71) Applicants :
  • TYCO HEALTHCARE GROUP LP (United States of America)
(74) Agent: OSLER, HOSKIN & HARCOURT LLP
(74) Associate agent:
(45) Issued:
(22) Filed Date: 2009-07-09
(41) Open to Public Inspection: 2010-01-14
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data:
Application No. Country/Territory Date
61/080,317 United States of America 2008-07-14
12/499,300 United States of America 2009-07-08

Abstracts

English Abstract





The present disclosure relates to a filament for use in surgical procedures.
The filament
includes a first end with a first tangible indicator and a second end with a
second, different
tangible indicator. The first and second tangible indicators attribute
different surface
topographies to the respective first and second ends of the filament to
provide a way of
differentiating therebetween through tactile engagement.


Claims

Note: Claims are shown in the official language in which they were submitted.





WHAT IS CLAIMED IS:



1. A surgical filament for joining tissue during a surgical procedure,
comprising:
first and second ends; and

a tangible structure included on at least one of the first and second ends to
facilitate differentiation between the first and second ends through tactile
engagement.


2. The filament recited in claim 1, wherein the tangible structure includes a
first
tangible indicator included on the first end of the filament and a second
tangible indicator
included on the second end of the filament, wherein the first and second
tangible indicators
each define differing surface topographies such that the filament defines a
variable configuration
between the first and second ends.


3. The filament recited in claim 2, wherein the first and second tangible
indicators
each include at least one protrusion extending outwardly of an outer surface
of the filament.


4. The filament recited in claim 3, wherein the at least one protrusion of the
first and
second tangible indictors include at least one barb.


5. The filament recited in claim 3, wherein the at least one protrusion of the
first
tangible indicator defines a first configuration and the at least one
protrusion of the second
tangible indicator defines a second configuration, wherein the first
configuration and the second
configuration are different.



20



6. The filament recited in claim 3, wherein the first and second tangible
indicators
include differing numbers of protrusions.


7. The filament recited in claim 3, wherein the first and second tangible
indicators
include the same number of protrusions, wherein the at least one protrusion of
the first tangible
indicator defines a first dimension and the at least one protrusion of the
second tangible
indicator defines a second dimension, wherein the first dimension and the
second dimension
are different.


8. The filament recited in claim 3, wherein the first and second tangible
indicators
each include at least two protrusions, wherein the at least two protrusions of
the first tangible
indicator define a first distance therebetween and the at least two
protrusions of the second
tangible indicator define a second distance therebetween, wherein the first
distance and the
distance are different.


9. The filament recited in claim 2, wherein the first and second tangible
indicators
each include at least one indentation extending into an outer surface of the
filament.


10. The filament recited in claim 9, wherein the at least one indentation of
the first
tangible indicator defines a first configuration and the at least one
indentation of the second
tangible indicator defines a second configuration, wherein the first
configuration and the second
configuration are different.


11. The filament recited in claim 9, wherein the first and second tangible
indicators
include differing numbers of indentations.



21




12. The filament recited in claim 9, wherein the first and second tangible
indicators
include the same number of indentations, wherein the first tangible indicator
includes
indentations defining a first dimension and the second tangible indicator
includes indentations
defining a second dimension, wherein the first dimension and the second
dimension are
different.


13. The filament recited in claim 9, wherein the first and second tangible
indicators
each include at least two indentations, wherein the at least two indentations
of the first tangible
indicator define a first distance therebetween and the at least two
indentations of the second
indicator define a second distance therebetween, wherein the first distance
and the distance are
different.


14. The filament recited in claim 1, further including an elongate body
extending
between the first and second ends, the elongate body defining a surface
topography that differs
from the surface topography defined by the tangible structure included on at
least one of the first
and second ends of the filament.


15. The filament recited in claim 2, wherein one of the first and second
tangible
indicators defines a surface topography that is substantially uniform.


16. The filament recited in claim 1, wherein the tangible structure included
on each of
the first and second ends of the filament includes at least one projection.


17. The filament recited in claim 16, wherein the tangible structure included
on each
of the first and second ends includes the same number of projections, wherein
the at least one


22



projection included on the first end of the filament differs in configuration
from the at least one
projection included on the second end of the filament.


18. The filament recited in claim 17, wherein the at least one projection
included on
the first end of the filament is configured as a loop and the at least one
projection included on
the second end of the filament is configured as an arrow-shaped member.


19. The filament recited in claim 16, wherein the number of projections
included on
the first end of the filament differs from the number of projections included
on the second end of
the filament.


20. The filament recited in claim 1, further including at least one needle
attached
thereto.


21. A multifilament suture comprising:

at least one filament including a first tangible indicator on a first end of
the
filament and a second tangible indicator on a second end of the filament,
wherein the first and
second tangible indicators each define differing surface topographies; and

at least one fiber commingled with the at least one filament.


23

Description

Note: Descriptions are shown in the official language in which they were submitted.



CA 02671628 2009-07-09

DIFFERENTIATION OF SURGICAL FILAMENTS
BACKGROUND

1. Technical Field

[0002] The present disclosure relates generally to apparatus for securing
together
tissue, and methods of manufacturing the same. More particularly, the present
disclosure
relates to a surgical filament incorporating different tangible indicators at
least one end to allow
a clinician to differentiate therebetween during use.

2. Backstround of the Related Art

[0003] In surgical procedures, sutures are used to repair openings in skin,
internal
organs, blood vessels, and the like, as in the case of meniscal repair, and to
join various tissues
together, as in the reattachment of ligaments or tendons to bone. Generally,
surgical
procedures can be categorized as either open procedures or minimally invasive
procedures.
[0004] Minimally invasive procedures, e.g., arthroscopic, endoscopic, and
laparoscopic
procedures, are generally performed through small openings in a patient's
tissue, such as a
natural opening in the body or an incision created through the use of a
scalpel. The presence of
tissue, blood, and other fluids at the surgical worksite can result in
decreased visibility and a


CA 02671628 2009-07-09

narrowed field of vision. As a result, it can be difficult for the clinician
to locate a suture,
ascertain its orientation, and/or distinguish between its ends should the
suture become
entangled during use. This difficulty is of course increased in those
procedures requiring the
simultaneous use of more than one suture.

[0005] Various advances have been made in an attempt to cope with decreased
visibility at the surgical worksite. For example, some sutures include one or
more colored
sections that can help the clinician discern between different sutures and
their ends. However,
there are limitations regarding which colors can be feasibly distinguished
from one another in
the presence of fluids and tissue. Sutures have also been developed that
include physical
characteristics the clinician can perceive through the sense of touch, rather
than sight. For
example, U.S. Patent Application Publication No. 2007/0225763 to Zwolinski et
al. (hereinafter
"Zwolinski"), filed on March 23, 2006, describes the use of physical markings
on the outer
surface of a suture. While the markings suggested by Zwolinski may provide
information
regarding, the amount of suture material, the length of the suture, the depth
of suture
penetration, or the tension being applied to the suture, improvements in the
field are desired to
allow the clinician to distinguish one end of the suture from the other.

SUMMARY
[0006] In one aspect of the present disclosure, a surgical filament is
disclosed for joining
tissue during a surgical procedure. The filament has first and second ends
including tangible
structure that facilitates differentiation therebetween through tactile
engagement. The tangible
structure includes a first tangible indicator at the first end of the filament
and a second tangible
indicator at the second end of the filament. The first and second tangible
indicators define
differing surface topographies, and as such, the filament defines a
configuration that varies
between the first and second ends thereof.

2


CA 02671628 2009-07-09

[0007] In one embodiment, the first and second tangible indicators include at
least one
protrusion extending outwardly of an outer surface of the filament. The at
least one protrusion
of the first tangible indicator may define a configuration that is different
from that of the at least
one protrusion of the second tangible indicator.

[0008] The first and second tangible indicators may include the same or
differing
numbers of protrusions. However, where the first and second tangible
indicators include the
same number of protrusions, the at least one protrusion of the first tangible
indicator may define
a dimension that is different from that of the at least one protrusion of the
second tangible
indicator.

[0009] The first and second tangible indicators may each include at least two
protrusions, in which case the at least two protrusions of the first tangible
indicator may define a
distance therebetween that is different than the distance defined between the
at least two
protrusions of the second tangible indicator.

[0010] In an alternative embodiment, the first and second tangible indicators
may each
include at least one indentation extending into an outer surface of the
filament. The at least one
indentation of the first tangible indicator may define a configuration that is
different from that of
the at least one protrusion of the second tangible indicator.

[0011] The first and second tangible indicators may include the same or
differing
numbers of indentations. However, where the first and second tangible
indicators inciude the
same number of indentations, the at least one indentation of the first
tangible indicator may
define a dimension that is different from that of the at least one indentation
of the second
tangible indicator.

3


CA 02671628 2009-07-09

[0012] The first and second tangible indicators may each include at least two
indentations, in which case, the at least two indentations of the first
tangible indicator may
define a distance therebetween that is different than the distance defined
between the at least
two indentations of the second tangible indicator.

[0013] The filament further includes an elongate body, or central portion,
extending
between the first and second ends. The elongate body may define a surface
topography that
differs from that defined by the tangible structure included on at least one
of the first and second
ends of the surgical filament.

[0014] In another embodiment, one of the first and second tangible indicators
defines a
surface topography that is substantially uniform.

[0015] The filament may further include an anchor member connected to either,
or both
of the first and second ends that is configured to limit movement towards a
distal portion upon
insertion into tissue.

[0016] In one embodiment of the filament, the tangible structure includes one
or more
projections orr each of the first and second ends. The projections may be
present at each end
of the filament in the same or different numbers. To facilitate
differentiation between the first
and second ends through tactiie engagement, the projections included on the
first end may
differ in number and/or configuration from the projections included on the
second end. For
example, the projections included on the first end may be configured as loops,
whereas the
projections included on the second end may be configured as arrow-shaped
members. Where
the first and second ends of the filament include differing numbers of
projections, the projections
included on the first and second ends may define the same configuration.

4


CA 02671628 2009-07-09

[0017] In another aspect of the present disclosure, a surgical suture for
joining tissue
during a surgical procedure is disclosed. The suture includes at least one
surgical fiber and at
least one surgical filament arranged so as to define a plurality of
interstices therebetween. The
at least one surgical filament has first and second ends including tangible
structure that allows a
clinician to differentiate between the ends of the suture through tactile
engagement.

[0018] The present disclosure also relates to a method of manufacturing a
surgical
filament for joining tissue during a surgical procedure. The method includes
the steps of
providing a surgical filament having a first end and a second end, and forming
tangible structure
at each of the first and second ends to facilitate differentiation
therebetween through tactile
engagement.

[0019] The present disclosure further relates to a method of manufacturing a
surgical
suture for joining tissue during a surgical procedure. The method includes the
steps of
providing at least one surgical fiber, providing at least one surgical
filament having a first end
and a second end, forming tangible structure at each of the first and second
ends of the
filament, and arranging the at least one fiber and the at least one filament
so as to define a
plurality of interstices therebetween. Including the tangible structure on
each of the first and
second ends of the at least one filament allows a clinician to differentiate
between ends of the
suture through tactile engagement.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Various embodiments of the present disclosure are described herein
below with
reference to the drawings, wherein:



CA 02671628 2009-07-09

Attorney Docket: H-US-01340 (1700-12)
[0021] FIG. 1 is a side, plan view of one embodiment of a filament for use
during a
surgical procedure with first and second ends having first and second tangible
indicators,
respectively, that each include at least one protrusion;

[0022] FIG. 2 is a side plan view of another embodiment of a filament of the
present
disclosure;

[0023] FIG. 2A is an end view of the first end of the filament shown in FIG. 2
illustrating
the first tangible indicator;

[0024] FIG. 2B is an end view of the second end of the filament shown in FIG.
2
illustrating the second tangible indicator;

[0025] FIG. 3 is a side, plan view of an alternative embodiment of a filament
in
accordance with the present disclosure;

[0026] FIG. 4 is a side, plan view of another embodiment of a filament in
accordance
with the present disclosure;

[0027] FIG. 4A is an end view of a first end of the filament shown in FIG. 4
illustrating a
first tangible indicator; [0028] FIG. 4B is an end view of a second end of the
filament shown in FIG. 4

illustrating a second tangible indicator;

[0029] FIG. 5 is a side, plan view of another alternative embodiment of the
filament in
accordance with the present disclosure;

[0030] FIGS. 6-10 are side, plan views of the filament shown in of FIG. 1
illustrating
alternative configurations for the protrusions of the first and second
tangible indicators;

6


CA 02671628 2009-07-09

Attorney Docket: H-US-01340 (1700-12)
[0031] FIG. 11 is a side, plan view of another embodiment of a filament of the
present
disclosure with first and second ends having first and second tangible
indicators, respectively,
that each include at least one indentation;

[0032] FIG. 12 is a side, plan view illustrating the embodiment of the
filament shown in
FIG. 11;

[0033] FIG.12A is an end view of a first end of the filament shown in FIG. 12
illustrating
the first tangible indicator;

[0034] FIG. 12B is an end view of a second end of the filament shown in FIG.
12
illustrating the second tangible indicator;

[0035] FIG. 13 is a side, plan view of an alternative embodiment of a filament
in
accordance with the present disclosure;

[0036] FIG. 14 is a side, plan view of still another embodiment of a filament
in
accordance with the present disclosure;

[0037] FIG.14A is an end view of a first end of the-filament shown in FIG. 14
illustrating
the first tangible indicator;

[0038] FIG. 14B is an end view of a second end of the filament shown in FIG.
14
illustrating the second tangible indicator;

[0039] FIG. 15 is a side, plan view of an alternative embodiment of a filament
in
accordance with the present disclosure;

[0040] FIGS. 16-20 are side, plan views of a filament illustrating alternative
configurations for the indentations of the first and second tangible
indicators;

7


CA 02671628 2009-07-09

[0041] FIGS. 21-24 are side, plan views of filaments in accordance with the
present
disclosure incorporating first and second tangible indicators that include
projections associated
with the ends of the filaments;

[0042] FIG. 25 is a side, plan view of an additional embodiment of a filament
in
accordance with the present disclosure including an elongate body, or central
portion, that
defines the same topography as one of the first and second ends of the
filament;

[0043] FIG. 26 is a side, plan view of an alternative embodiment of a filament
in
accordance with the present disclosure;

[0044] FIG. 27 is a side, plan view of a suture for use during a surgical
procedure that
includes a plurality of fibers intertwined with a filament having first and
second ends that include
first and second tangible indicators, respectively;

[0045] FIG. 28 is a side, plan view of an alternative embodiment of the suture
shown in
FIG. 27;

[0046] FIG. 29 is a side, cross-sectional view of the filament shown in FIG. 1
shown in
connection with a pair of anchor members; and

[0047] FIG. 30 is a perspective view of the filament shown in FIG. 1 in
connection with a
surgical needle and illustrating a method of attaching tissue segments.

DETAILED DESCRIPTION

[0048] In the drawings and in the description which follows, in which like
references
characters identify similar or identical elements, the term "filament" should
be understood as
referring to any elongate member suitable for the intended purpose of joining
tissue, including
but not limited to sutures, ligatures, and surgical tape. In addition, the
term "tissue" should be
8


CA 02671628 2009-07-09

understood as referring to any bodily tissue, including but not limited to
skin, fascia, ligaments,
tendons, muscle, and bone.

[0049] FIG. 1 illustrates one embodiment of a filament, referred to generally
by
character 100. The filament 100 can be formed from any suitable biodegradable
or non-
biodegradable material. Suitable biodegradable materials which may be used to
construct a
filament of the present disclosure include polymers such as those made from
lactide, glycolide,
caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate,
tetramethylene
carbonate, and the like), dioxanones (e.g., 1,4-dioxanone), 1,dioxepanones
(e.g., 1,4-dioxepan-
2-one and 1,5-dioxepan-2-one), ethylene glycol, ethylene oxide, esteramides, y-

hydroxyvalerate, P-hydroxypropionate, alpha-hydroxy acid, hydroxybuterates,
poly (ortho
esters), hydroxy alkanoates, tyrosine carbonates, polyimide carbonates,
polyimino carbonates
such as poly (bisphenol A-iminocarbonate) and poly (hydroquinone-
iminocarbonate),
polyurethanes, polyanhydrides, polymer drugs (e.g., polydiflunisol,
polyaspirin, and protein
therapeutics) and copolymers and combinations thereof. Suitable natural
biodegradable
polymers include collagen, cellulose, poly (amino acids), polysaccharides,
hyaluronic acid, silk
gut, copolymers and combinations thereof. Suitable non-biodegradable materials
which may be
used to construct a filament of the present disclosure include fluorinated
polymers (e.g.,
fluoroethylenes, propylenes, fluoroPEGs), polyolefins such as polyethylene,
polyesters such as
poly ethylene terepththalate (PET), nylons, polyamides, polyurethanes,
silicones, ultra high
molecular weight polyethylene (UHMWPE), polybutesters, polyaryletherketone,
steel,
copolymers and combinations thereof. Additionally, non-biodegradable polymers
and
monomers may be combined with each other and may also be combined with various
biodegradable polymers and monomers to create a composite filament.

9


CA 02671628 2009-07-09

[0050] Desirably, the filament 100 has a measure of flexibility such that the
filament 100
can be manipulated by a clinician to join adjacent sections of tissue
together. As an illustrative
example, the filament 100 may be used to repair or close an incision, wound,
or the like using
conventional suturing techniques.

[0051] The filament 100 includes a first end 102, a second end 104, and an
elongate
body, or central portion, 106 that extends therebetween. The first end 102
includes a first
tangible indicator 108 and the second end 104 includes a second, different
tangible indicator
110. The tangible indicators 108, 110 can include any structure that is
tactually perceptible by a
clinician. Incorporating different tangible indicators 108, 110 provides a way
of differentiating
between the ends 102, 104 of the filament 100 through tactile engagement.

[0052] In the embodiment of the filament 100 seen in FIG. 1, the respective
first and
second tangible indicators 108, 110 each include one or more raised
protrusions 112 extending
outwardly of an outer surface 114 of the filament 100. However, the tangible
indicators 108,
110 differ in the number of protrusions 112 that they include. As shown, the
first tangible
indicator 108 includes a single protrusion 112, whereas the second tangible
indicator 110
includes a pair of protrusions 112. It should be appreciated that the
protrusions 112 may be
present in either greater or fewer numbers in altemative embodiments of the
filament 100.

[0053] FIGS. 2-24 illustrate various embodiments of the filament 100, each of
which is
similar to the filament 100 seen in FIG. 1, but for the specific topographies
of their ends that are
attributable to the incorporation of various tangible indicators. Accordingly,
each embodiment of
the filament 100 will only be discussed with respect to the tangible
indicators that they include.
[0054] FIGS. 2-213 illustrate a filament 200 including first and second
tangible indicators
208, 210, respectively, with one or more protrusions 212. In contrast to the
filament 100 seen in
FIG. 1, which includes indicators 108, 110 that have differing numbers of
protrusions 112, the


CA 02671628 2009-07-09

tangible indicators 208, 210 each include an identical number of protrusions
212. However, the
tangible indicators 208, 210 are distinguished from one another through the
inclusion of
protrusions 212 that vary in size. Alternatively, the tangible indicators 208,
210 may include
protrusions 212 that have different relative spacing or different
configurations.

[0055] As seen in FIGS. 2-2B, in one embodiment, the tangible indicators 208,
210 each
include three protrusions 212 that are spaced equally from each other by a
distance "C". In this
embodiment, the first indicator 208 and the second indicator 210 differ in the
size of the
protrusions 212 that they include. The first tangible indicator 208 includes
protrusions 212 that
extend outwardly from the outer surface 214 of the filament 200 to define a
first height "H,",
whereas the second tangible indicator 210 includes three protrusions 212 that
extend outwardly
from the outer surface 214 to define a second, greater height "HZ". While
illustrated as
extending along the periphery of the filament 200, the protrusions 212 may
alternatively extend
along the length of the filament 200 such that they are spaced axially from
one another, as seen
in FIG. 3.

[0056] FIGS. 4-4B illustrate another embodiment of the filament, referred to
as filament
"300, with first and second tangible indicators 308, 310 that each include
three protrusions 312
defining a substantially identical height "H". In this embodiment, the
tangible indicators 308, 310
are distinguished by the distance or spacing between adjacent protrusions 312.
The first
tangible indicator 308 includes protrusions 312 that are spaced along the
periphery of the
filament 300 to define a first distance "C," therebetween, whereas the second
tangible indicator
310 includes protrusions 312 that are spaced along the periphery of the
filament 300 to define a
second, greater distance "C2" therebetween. Alternatively, as seen in FIG. 5,
the protrusions
312 may be spaced linearly from each other to define a first distance "L,"
therebetween at the
first end 302 of the filament 300 and a second, greater distance "LZ"
therebetween at the second
end 304.

11


CA 02671628 2009-07-09

[0057] While the protrusions seen in FIGS. 1-5, e.g., protrusions 112 (FIG.
1), are
depicted as substantially hemispherical protuberances 116, the protrusions 112
may define any
configuration suitable for the intended purpose of providing structure that is
tactually perceptible
by a clinician. As illustrative examples, in alternative embodiments, the
protrusions 112 may
define fins 118, as seen in FIG. 6, linear ribs 120, as seen in FIG. 7, or
annular ribs 122, as
seen in FIG. 8.

[0058] With reference now to FIG. 9, another embodiment of the filament,
referred to as
filament 400, is illustrated with first and second tangible indicators 408,
410, respectively, that
include an equal number of protrusions 412. In this embodiment, the tangible
indicators 408,
410 are distinguished by the configuration of the protrusions 412 that they
include. For
example, in the embodiment seen in FIG. 9, the first tangible indicator 408
includes a protrusion
412 configured as the aforedescribed protuberance 416, whereas the second
tangible indicator
410 includes a protrusion 412 defining an annular rib 422. FIG. 10 illustrates
another example
of a filament 500 that includes a first tangible indicator 508 with a
protrusion 512 defining a fin
518 that subtends a first angle a with respect to the longitudinal axis "A"
defined by the filament
500, and a second tangible indicator 510 with a protrusion 512 defining a fin
518 that subtends
a second, different angle P with respect to the longitudinal axis "A".

[0059] FIG. 11 illustrates yet another embodiment of the filament, referred to
as filament
600, with first and second tangible indicators 608, 610, respectively, that
each include one or
more indentations 624 extending into the outer surface 614 of the filament
600. The first and
second tangible indicators 608, 610 differ from each other, however, in the
number of
indentations 624 that they include. As shown, the first tangible indicator 608
includes a single
indentation 624, whereas the second tangible indicator 610 includes a pair of
indentations 624.
It should be appreciated that the indentations 624 may be present in either
greater or fewer
numbers in alternative embodiments of the filament 600.

12


CA 02671628 2009-07-09

[0060] FIGS. 12-12B illustrate a filament 700 with first and second tangible
indicators
708, 710 that also include one or more indentations 724. In contrast to the
filament 600 seen in
FIG. 11, which includes first and second tangible indicators 608, 610 having
different numbers
of indentations 612, the first and second tangible indicators 708, 710 of the
filament 700 include
an identical number of indentations 724 that vary in size. Alternatively, the
tangible indicators
708, 710 may include indentations 724 that have different relative spacing or
different
configurations.

[0061] In one embodiment, the tangible indicators 708, 710 each include three
indentations 724 spaced equally from each other by a distance "C". In this
embodiment, the first
indicator 708 and the second indicator 710 are distinguished from each other
by the size of the
indentations 724 that they include. The first tangible indicator 708 includes
indentations 724
that define a first dimension "D,", whereas the second tangible indicator 710
includes three
indentations 724 that define a second, greater dimension "D2". While
illustrated as extending
along the periphery of the filament 700, the indentations 724 may
alternatively extend along the
length of the filament 700 such that they are spaced axially from one another,
as seen in FIG.
13.

[0062] FIGS. 14-14B illustrate another embodiment, referred to as filament
800, with
tangible indicators 808, 810 including indentations 824 that define a
substantially identical
dimension "D". In this embodiment, the tangible indicators 808, 810 are
distinguished from each
other by the distance between adjacent indentations 824. The first tangible
indicator 808
includes indentations 824 that are spaced along the periphery of the filament
800 to define a
first distance "C," therebetween, whereas the second tangible indicator 810
includes
indentations 824 that are spaced along the periphery of the filament 800 to
define a second,
greater distance "C2" therebetween. Alternatively, as seen in FIG. 15, the
first tangible indicator
808 may include three indentations 824 that are spaced linearly from each
other along the
13


CA 02671628 2009-07-09

length of the filament 800 to define a first distance "L," therebetween,
whereas the second
tangible indicator 810 may include three protrusions 824 that are spaced from
each other by a
second, greater distance "L2".

[0063] While the indentations seen in FIGS. 11-15, e.g., indentations 624
(FIG. 11), are
depicted as substantially hemispherical depressions 626, the protrusions 624
may define any
configuration suitable for the intended purpose providing structure that is
tactually perceptible by
a clinician. As illustrative examples, the indentations 624 may define
substantially triangular
configurations 628, as seen in FIG. 16, linear channels 630, as seen in FIG.
17, or arcuate
channels 632, as seen in FIG. 18.

[0064] With reference now to FIG. 19, another embodiment of the filament,
referred to
as filament 900, is illustrated having a first tangible indicator 908 and a
second tangible indicator
910 with an equal number of indentations 924. However, the tangible indicators
908, 910 differ
in the configuration of the indentations 924 that they include. In the
embodiment seen in FIG.
19, for example, the first tangible indicator 908 includes an indentation 924
defining the same
substantially hemispherical depression 926 discussed above, whereas the second
tangible
indicator 910 includes an indentation 924 defining an arcuate channel 932.

[0065] With reference now to FIG. 20, an embodiment of the filament referred
to by
reference character 1000 is disclosed that includes first and second tangible
indicators 1008,
1010, respectively. The first tangible indicator 1008 includes a substantially
smooth surface
1034, whereas the second tangible indicator 1010 defines a knurled, or scarred
surface 1036
such that a clinician may differentiate between the respective first and
second ends 1002, 1004
of the filament 1000.

[0066] Tuming now to FIGS. 21-24, additional embodiments of the filament will
be
discussed. The filament 1100 incorporates first and second tangible indicators
1108, 1110 that
14


CA 02671628 2009-07-09

include projections 1112 extending beyond the first and second ends 1102, 1104
of the filament
1100, respectively. The projections 1112 may extend from the first and second
ends 1102,
1104 of the filament 1100, as shown in FIGS. 21-22, for example.
Alternatively, it is envisioned
that either or both of the first and second tangible indicators 1108, 1110 may
include projections
1112 that are integrally formed with the first and second ends 1102, 1104 of
the filament 1100,
respectively. For example, FIG. 23 illustrates the filament 1100 incorporating
a first tangible
indicator 1108 including a projection 1112 that extends from the first end
1102, and a second
tangible indicator 1110 including a projection 1112 that is integrally formed
with the second end
1104, whereas FIG. 24 illustrates the filament 1100 incorporating a first
tangible indicator 1108
including a plurality of projections 1112 that are integrally formed with the
first end 1102 and a
second tangible indicator 1110 including a single projection 1112 that extends
from the second
end 1104.

[0067] To facilitate differentiation between the ends 1102, 1104 of the
filament 1100
through tactile engagement, the first and second tangible indicators 1108,
1110 may include
differing numbers of projections 1112, as shown in FIGS. 21 and 24. Referring
specifically to
the embodiment of the filament 1100 shown in FIG. 21 as an example, the first
tangible indicator
1108 is illustrated as including a single projection 1112, whereas the second
tangible indicator
1110 is illustrated as including a pair of projections 1112. Alternatively,
the first and second
tangible indicators 1108, 1110 may include the same number of projections
1112, as shown in
FIGS. 22 and 23. In this case, to facilitate differentiation between the ends
1102, 1104 of the
filament 1100, the first tangible indicator 1108 will include projections 1112
defining one
configuration, and the second tangible indicator 1110 will include projections
1112 defining
another, different configuration. Referring specifically to the embodiment of
the filament 1100
shown in FIG. 22, the first tangible indicator 1108 includes a projection 1112
that is configured
as a loop 1114, whereas the second tangible indicator 1110 includes a
projection 1112 that is


CA 02671628 2009-07-09

configured as an arrow-shaped member 1116. In alternative embodiments of the
filament 1110,
the projections 1112 may be configured in any manner suitable for the intended
purpose of
allowing a clinician to differentiate between the ends 1102, 1104 of the
filament through tactile
engagement.

[0068] While each of the aforedescribed embodiments has been illustrated as
including
an elongate body that exhibits a different topography than each of the first
and second ends of
the filament, e.g., the elongate body 106 of the filament 100 seen in FIG. 1
defines a
substantially uniform topography in contrast to the textured topographies of
the respective first
and second ends 102, 104 attributable to the respective first and second
tangible indicators 108,
110, a filament including a elongate body that exhibits the same topography as
either of the first
and second ends is also within the scope of the present disclosure. For
example, FIG. 25
illustrates a filament 1200 that includes a first end 1202 with a first
tangible indicator 1208
having a single, linear protrusion 1212, a elongate body 1206 that also
includes the single,
linear protrusion 1212, and a second end 1204 with a second tangible indicator
1210 having a
pair of linear protrusions 1212. Alternatively, as seen in FIG. 26, a filament
1300 is disclosed
that includes a first end 1302 having a first tangible indicator 1308 defining
a substantially
smooth surface 1334, as discussed above with respect to FIG. 20, an elongate
body 1306 that
includes a knurled surface 1336, and a second end 1304 having a second
tangible indicator
1310 that also includes a knurled surface 1336.

[0069] Referring again to FIG. 1, a method of manufacturing the filament 100
will be
described. Initially, a length of the filament 100 is provided, which may be
varied dependent
upon the intended use thereof. The tangible indicators 108, 110 are thereafter
formed at the
respective first and second ends 102, 104 of the filament 100. The tangible
indicators 108, 110
may be formed through any suitable method, including but not being limited to
molding, casting,
extrusion, laser shaping, or mechanical processes, such as milling and/or
grinding.

16


CA 02671628 2009-07-09

[0070] With reference now to FIGS. 27-28, a suture 1400 is disclosed. The
suture 1400
includes one or more fibers 1500 commingled with any of the filaments
discussed herein above.
The filaments may be any of the filaments illustrated in the embodiments of
FIGS. 1-25 or
combinations thereof. For example, in one embodiment, the suture 1400 includes
fibers 1500
and the filament 100 discussed with respect to FIG. 1. The fibers 1500 and the
filament 100 are
arranged to define a plurality of interstices 1438 therebetween, and may be
arranged in any
manner suitable for this intended purpose, including but not limited to
braiding, entangling,
weaving, or comingling of the fibers 1500 and the filament 100. The fibers
1500 and the
filament 100 may be arranged in a braided configuration, as seen in FIG. 27,
or alternatively, the
fibers 1500 and the filament 100 may be loosely interwoven, as seen in FIG.
28. While the
suture 1400 is illustrated as including only a single filament 100 among the
fibers 1500, in
alternative embodiments, the suture 1400 may include a greater number of
filaments 100. As
stated above, it is envisioned that suture 1400 may include any one or more of
the filaments
discussed above and is not limited to the embodiment shown.

[0071] To manufacture the suture 1400, initially, a length of the filament 100
(FIG. 1) is
processed to ftfine tangible indicators 108, 110 at the ends 102, 104 thereof,
as pre!giously
described. Thereafter, the filament 100 and the fibers 1500 are arranged such
that the plurality
of interstices 1438 are defined therebetween.

[0072] Referring now to FIG. 29, any of the filaments discussed herein above,
such as,
for example, the filament 100 described with respect to FIG. 1, or the suture
1400 described
with respect to FIGS. 27-28, may be used in conjunction with one or more
anchor members
1600 of either the cannulated variety, as shown, or the non-cannulated
variety. It is envisioned
that any of the filaments described in any of the previous embodiments may be
used in
conjunction with the anchor members 1600 of the present embodiment such that
the tangible
indicators on the ends of the filament are exposed when the anchor member is
buried into bone
17


CA 02671628 2009-07-09

and/or tissue. The anchor members 1600 define a configuration that is at least
partially tapered
near their bottom ends 1602 to facilitate insertion thereof, although a non-
tapered configuration
is also within the scope of the present disclosure. In alternative
embodiments, the bottom ends
1602 may be substantially blunt, as shown, or incisive to facilitate the
penetration of tissue. In
those embodiments, including multiple anchor members 1600, i.e., one anchor
member 1600
that is attached to each end 102, 104 of the filament 100, the anchor members
1600 may be
either substantially identical, as shown, or alternatively, the anchor members
1600 may define
different dimensions and/or include different materials. Each anchor member
1600 includes at
least one barb 1604 that is oriented so as to facilitate insertion of the
anchor member 1600 into
tissue and inhibit subsequent reversal thereof. Further details regarding the
structure and/or
function of the anchor members 1600 may be obtained through reference to
commonly owned
U.S. Patent No. 6,554,852 to Oberlander, the entire contents of which are
incorporated by
reference herein.

[0073J Referring now to FIG. 30, a method of using a surgical filament, e.g.,
the surgical
filament 100 discussed above with respect to FIG. 1, to join adjacent tissue
segments "TI" and
"TZ" will be discussed. To facilitate penetration of th%tissue segments "T,",
"T2", the surgical
filament 100 is attached to a surgical needle 1700. The surgical filament 100
may be attached
to the surgical needle 1700 through any suitable method, such as by inserting
the first end 102
of the surgical filament into a bore 1702 provided at a proximal end 1704 of
the surgical needle
1700, and thereafter crimping the proximal end 1704 of the surgical needle
1700. Altemative
methods of attaching the surgical filament 100 and the surgical needle 1700,
such as by
integrally forming the surgical needle 1700 with the surgical filament 100,
are also envisioned.
The tissue segments "T,", "TZ" may then be joined by passing the surgical
needle 1700, and
thus the surgical filament 100, through the tissue segments "T,", "T2" in any
suitable manner.
When visibility is limited, such as during the course of a procedure performed
at an internal
18


CA 02671628 2009-07-09

worksite for example, the different surface topographies of the tangible
indicators 108, 110 will
allow the practitioner to distinguish between the respective ends 102, 104 of
the surgical
filament 100. After the tissue segments "T,", "T2" have been successfully
joined, the surgical
needle 1700 can be removed from the surgical filament 100, and the surgical
filament 100 can
be tied.

[0074] Persons skilled in the art will understand that the devices and methods
specifically described herein and illustrated in the accompanying drawings are
intended to be
construed as non-limiting, exemplary embodiments, and that the features
illustrated or
described in connection with one exemplary embodiment may be combined with the
features of
other embodiments. Additionally, one skilled in the art will appreciate
further features and
advantages of the disclosure based on the above-described embodiments.
Accordingly, the
disclosure is not to be limited by what has been particularly shown and
described, except as
indicated by the appended claims.

19

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(22) Filed 2009-07-09
(41) Open to Public Inspection 2010-01-14
Dead Application 2015-07-09

Abandonment History

Abandonment Date Reason Reinstatement Date
2014-07-09 FAILURE TO REQUEST EXAMINATION
2014-07-09 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $400.00 2009-07-09
Maintenance Fee - Application - New Act 2 2011-07-11 $100.00 2011-06-21
Maintenance Fee - Application - New Act 3 2012-07-09 $100.00 2012-06-21
Maintenance Fee - Application - New Act 4 2013-07-09 $100.00 2013-06-25
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
TYCO HEALTHCARE GROUP LP
Past Owners on Record
ABUZAINA, FERASS
HOTTER, JOSEPH
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Cover Page 2010-01-04 1 29
Abstract 2009-07-09 1 12
Description 2009-07-09 19 819
Claims 2009-07-09 4 127
Drawings 2009-07-09 11 151
Representative Drawing 2009-12-17 1 3
Correspondence 2009-07-31 1 17
Correspondence 2009-07-13 2 82
Correspondence 2009-08-28 1 50
Assignment 2009-07-09 2 100
Correspondence 2010-02-25 1 12
Fees 2011-06-21 1 50
Fees 2012-06-21 1 52
Fees 2013-06-25 1 49