U.S. patent application number 11/110432 was filed with the patent office on 2006-10-26 for method and apparatus for suture placement.
Invention is credited to Daniel Cerundolo.
Application Number | 20060241658 11/110432 |
Document ID | / |
Family ID | 37188025 |
Filed Date | 2006-10-26 |
United States Patent
Application |
20060241658 |
Kind Code |
A1 |
Cerundolo; Daniel |
October 26, 2006 |
Method and apparatus for suture placement
Abstract
An apparatus and method for placing a suture by manipulating a
cannula and attached needle. The cannula may be usable in a
minimally-invasive surgical procedure, and the needle may be
selectively attached to and/or separated from the cannula. The
cannula and needle may include complementary locking members that
engage with each other and allow the needle to be used to place a
suture by manipulation of the cannula.
Inventors: |
Cerundolo; Daniel; (Hingham,
MA) |
Correspondence
Address: |
WOLF GREENFIELD & SACKS, PC
FEDERAL RESERVE PLAZA
600 ATLANTIC AVENUE
BOSTON
MA
02210-2206
US
|
Family ID: |
37188025 |
Appl. No.: |
11/110432 |
Filed: |
April 20, 2005 |
Current U.S.
Class: |
606/148 |
Current CPC
Class: |
A61B 17/0469 20130101;
A61B 17/1714 20130101; A61B 2017/0445 20130101; A61B 2017/3445
20130101; A61B 2017/06076 20130101; A61B 17/0485 20130101; A61B
17/1796 20130101; A61B 2017/0409 20130101; A61B 2017/0404 20130101;
A61B 17/0483 20130101; A61B 2017/06052 20130101; A61B 17/0487
20130101; A61B 2017/564 20130101; A61B 2017/0456 20130101; A61B
17/0401 20130101; A61B 17/1778 20161101 |
Class at
Publication: |
606/148 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. An apparatus comprising: a cannula having at least one lumen,
the cannula being constructed and arranged to be placed in an
arthroscopic portal in a minimally-invasive surgical procedure and
allow an instrument to be passed through the at least one lumen of
the cannula; and a needle attached to the cannula and having a
tissue penetrating portion adapted to carry a suture; wherein the
needle, when carrying a suture, is manipulable by movement of the
cannula to penetrate a material to place the suture in the
material.
2. The apparatus of claim 1, wherein the cannula has a groove with
a shape, and the needle has a portion with a shape that engages
with the groove.
3. The apparatus of claim 1, wherein rotation of the cannula causes
rotation of the tissue penetrating portion of the needle.
4. The apparatus of claim 1, wherein the needle has a hollow
portion that accommodates a suture.
5. The apparatus of claim 1, wherein the needle has a cannula
engaging portion that engages with the cannula and the tissue
penetrating portion is positioned distally of the cannula engaging
portion.
6. The apparatus of claim 1, wherein the cannula has a longitudinal
axis and the tissue penetrating portion includes a curved end
portion positioned in a plane that is transverse to the
longitudinal axis.
7. The apparatus of claim 6, wherein rotation of the cannula about
the longitudinal axis causes the curved end portion to travel along
an arc-shaped path.
8. The apparatus of claim 1, wherein the cannula has a longitudinal
axis, and rotation of the cannula about the longitudinal axis
causes the tissue penetrating portion to move in an arc-shaped
path.
9. The apparatus of claim 1, wherein the cannula has a longitudinal
axis, and the tissue penetrating portion is positioned in a plane
that is transverse to the longitudinal axis.
10. The apparatus of claim 1, wherein the cannula has a
longitudinal axis, and the tissue penetrating portion includes a
semicircular end portion that lies in a plane perpendicular to the
longitudinal axis.
11. The apparatus of claim 10, wherein the cannula has a
longitudinal axis that passes through a center of a lumen of the
cannula and passes through a center of the semicircular end
portion.
12. The apparatus of claim 1, wherein the tissue penetrating
portion includes a hollow section adapted to carry a suture.
13. The apparatus of claim 1, wherein the needle is hollow along
its length to carry a suture.
14. The apparatus of claim 1, wherein the cannula includes a valve
that inhibits the flow of fluid through a lumen of the cannula.
15. The apparatus of claim 1, wherein the cannula and needle are
constructed and arranged to place a suture in a rotator cuff.
16. The apparatus of claim 1, wherein the cannula and needle are
constructed and arranged to form a mattress stitch in a rotator
cuff.
17. The apparatus of claim 1, wherein the needle is movable axially
relative to the cannula.
18. The apparatus of claim 1, wherein the cannula has a
longitudinal axis, and the needle is movable in a direction
generally along the longitudinal axis relative to the cannula.
19. The apparatus of claim 1, wherein the cannula and the needle
have complementary locking members that are engagable so that the
needle is operable to place the suture based on movement of the
cannula.
20. The apparatus of claim 19, wherein the cannula has an
oval-shaped groove and the needle has at least one oval-shaped
portion that engages with the oval-shaped groove.
21. The apparatus of claim 1, wherein the needle is selectively
separable from the cannula.
22. A method of performing a surgical procedure, comprising:
attaching a needle to a cannula, the needle being constructed and
arranged to carry a suture; providing the cannula and needle in an
arthroscopic portal, the cannula being constructed and arranged to
allow an instrument to be passed through a lumen of the cannula and
used at a surgical site; and manipulating the cannula so as to use
the needle to penetrate a material to place a suture in the
material.
23. The method of claim 22, wherein the material is a rotator cuff
tendon.
24. The method of claim 23, further comprising: securing the suture
and rotator cuff tendon to a portion of a humerus.
25. The method of claim 22, wherein the step of manipulating
comprises rotating the cannula about a longitudinal axis of the
cannula.
26. The method of claim 22, wherein the step of manipulating
comprises placing a mattress stitch in the material.
27. The method of claim 22, wherein the needle is removably
attached to the cannula.
28. The method of claim 22, further comprising moving the needle
axially relative to the cannula.
29. The method of claim 22, wherein the needle includes a material
engaging portion that is hollow and accommodates the suture.
30. The method of claim 22, further comprising inserting a surgical
instrument in a lumen of the cannula while the needle is attached
to the cannula.
31. An apparatus comprising: a cannula having at least one lumen
and constructed and arranged to be used in a minimally-invasive
surgical procedure and allow an instrument to be passed through the
at least one lumen of the cannula, the cannula having at least one
feature adapted to engage with a needle such that the needle, when
carrying a suture, is manipulable by movement of the cannula to
place the suture in a material.
32. The apparatus of claim 31, wherein the cannula is arranged to
allow the needle to be movable axially relative to the cannula
while remaining engaged with the cannula.
33. The apparatus of claim 32, wherein the cannula has a
longitudinal axis, and the cannula is arranged to allow movement of
the needle in a direction generally along the longitudinal axis
relative to the cannula.
34. The apparatus of claim 31, wherein the cannula has at least one
locking member that is complementary and engagable with at least
one locking member associated with the needle.
35. The apparatus of claim 31, wherein the lumen of the cannula has
a longitudinal axis, and the cannula is arranged to engage with the
needle so that rotation of the cannula about the longitudinal axis
causes rotation of a tissue penetrating portion of the needle.
36. The apparatus of claim 31, wherein the needle is removably
engagable with the cannula.
37. The apparatus of claim 31, wherein the cannula includes at
least one groove adapted to engage with at least a portion
associated with the needle.
38. An apparatus comprising: a needle constructed and arranged to
carry a suture and to engage with a cannula having at least one
lumen, the cannula being constructed and arranged to be placed in
an arthroscopic portal in a minimally-invasive surgical procedure
and allow an instrument to be passed through the at least one lumen
of the cannula and used at a surgical site, engagement of the
needle and the cannula being arranged so that the needle is
manipulable by movement of the cannula in a minimally-invasive
surgical procedure to place a suture in a material.
39. The apparatus of claim 38, wherein the needle has at least one
locking member that is complementary and engagable with at least
one locking member associated with the cannula.
40. The apparatus of claim 38, wherein the needle is arranged to
engage with at least one groove associated with the cannula.
41. The apparatus of claim 38, wherein the needle is removably
engagable with the cannula.
42. The apparatus of claim 38, wherein the needle includes a curved
tissue penetrating portion that is arranged to move in a circular
path when the needle is engaged with the cannula and the cannula is
rotated about a longitudinal axis.
43. The apparatus of claim 38, wherein the needle includes a hollow
portion adapted to carry a suture.
Description
BACKGROUND OF INVENTION
[0001] 1. Field of Invention
[0002] This invention relates to methods and apparatus for suture
placement.
[0003] 2. Discussion of Related Art
[0004] Surgical procedures frequently involve the placement of
suture in a material, such as body tissue, a prosthetic or other
medical implant or device, or combinations thereof. Many different
approaches and devices have been developed for suture placement.
For example, suturing instruments exist for placing sutures in body
tissues or other materials. One such device is the SMARTSTITCH
suturing device sold by Opus Medical of San Juan Capistrano, Calif.
This device may be used in an arthroscopic technique to place a
mattress stitch in a rotator cuff tendon when reattaching the
tendon to the humerus. The device has a set ofjaws that are used to
clamp the tendon, and then fire a pair of retractable needles that
extend through the tendon, engage suture, and draw the suture
through the tendon as the needles retract.
[0005] FIG. 1 shows a schematic diagram of a humerus 1 and a
portion of a rotator cuff tendon 2 that is normally attached to the
head of the humerus. In one type of damage to the rotator cuff, the
tendon 2 may detach or be partially torn from the humerus 1, such
as that shown schematically in FIG. 2. Such damage may be repaired
by reattaching the rotator cuff tendon to the humerus 1 by a suture
or other fixation so that the body's normal healing processes can
naturally effect reattachment of the tendon to the bone. One repair
technique for reattaching the rotator cuff2 to the humerus 1
involves fixing an anchor 101 at a margin between the articulating
portion 11 of the humerus 1 and the humerus' greater tuberosity 12.
A suture 102 is secured to the rotator cuff 2, e.g., using the
suturing device described above, and is secured to the anchor 101.
The suture 102 is then tensioned so that the rotator cuff 2 is held
in place close to the humerus 1. Thereafter, the body may
reestablish the proper attachment of the rotator cuff2 to the
humerus 1.
SUMMARY OF INVENTION
[0006] In one aspect of the invention, an apparatus includes a
cannula having at least one lumen and that is constructed and
arranged to be used in a minimally-invasive surgical procedure. For
example, such a cannula may be usable in an arthroscopic procedure
when performing surgery on a shoulder or knee. A needle may be
attached to the cannula and may have a tissue penetrating portion
adapted to carry a suture. The needle may be manipulated by
movement of the cannula to place the suture in a material. One
feature that may be provided in some embodiments is to allow the
cannula to be used for other additional purposes, such as
visualization of the surgical site through the same cannula used to
place a suture by providing an endoscopic camera in the cannula
lumen. In addition, or alternately, another surgical instrument may
be provided in the cannula, such as a grasping device that is used
to hold a material in place while the needle is used to place a
suture in the material.
[0007] In one aspect of the invention, the needle may be
selectively attached to and/or separated from the cannula. For
example, the cannula and needle may include complementary locking
members that engage with each other and allow the needle to be used
to place a suture by manipulation of the cannula. The cannula may
be usable in a minimally-invasive procedure, and then the needle
engaged with/disengaged from the cannula as needed.
[0008] Aspects of the invention provided a cannula and needle
arrangement that may be used to place a stitch in a rotator cuff
during a surgical repair. However, not all aspects of the invention
are restricted to use in rotator cuff repair.
BRIEF DESCRIPTION OF DRAWINGS
[0009] Various aspects of the invention are described with
reference to illustrative embodiments, wherein like numerals
reference like elements, and wherein:
[0010] FIG. 1 is a schematic diagram of a head of a humerus and
attached rotator cuff tendon;
[0011] FIG. 2 shows a prior art technique for repairing a rotator
cuff injury;
[0012] FIG. 3 is a schematic diagram of a tissue repair arrangement
in accordance with an aspect of the invention;
[0013] FIGS. 4-6 show the use of a needle for placing a suture in a
tissue in accordance with the invention;
[0014] FIG. 7 shows a needle in engagement with a cannula in
accordance with an aspect of the invention;
[0015] FIG. 8 shows an illustrative arrangement for engaging a
needle with a cannula in one embodiment;
[0016] FIG. 9 shows an illustrative arrangement for engaging a
sleeve and needle assembly with a cannula in accordance with
another embodiment;
[0017] FIG. 10 shows a guide apparatus used in forming a passageway
in accordance with the invention;
[0018] FIG. 11 shows the use of a guide apparatus for passing a
suture or other element through a transosseous passageway in
accordance with the invention;
[0019] FIG. 12 shows a technique for passing a suture placed in a
tissue through a passageway;
[0020] FIG. 13 shows the engagement of a suture with a suture
fixation device in accordance with the invention;
[0021] FIG. 14 shows the placement of a suture fixation device
relative to the bone in accordance with the invention;
[0022] FIG. 15 shows a suture fixation device engagement tool in
engagement with a suture fixation device in accordance with the
invention; and
[0023] FIGS. 16A-B and 17A-B show side and rear views,
respectively, of illustrative embodiments of suture fixation
devices in accordance with the invention.
DETAILED DESCRIPTION
[0024] This invention is not limited in its application to the
details of construction and the arrangement of components set forth
in the following description or illustrated in the drawings. The
invention is capable of other embodiments and of being practiced or
of being carried out in various ways. Also, the phraseology and
terminology used herein is for the purpose of description and
should not be regarded as limiting.
[0025] Various aspects of the invention are described below with
reference to specific embodiments. For example, aspects of the
invention are described in the context of performing a rotator cuff
repair. However, it should be understood that aspects of the
invention are not necessarily restricted to rotator cuff repair
techniques, or even to surgical techniques performed on a shoulder.
Rather, various aspects of the invention may be used in any
suitable surgical procedure. Also, aspects of the invention are
described in a procedure involving the formation of a transosseous
passageway, securing a suture in the passageway, etc. However, it
should be understood that aspects of the invention, such as aspects
relating to a cannula and attached needle, may be used in any
surgical procedure, such as a rotator cuff repair that involves the
use of an anchor like that shown in FIG. 2.
[0026] Various aspects of the invention may be used in an open
surgical procedure or in a closed or minimally-invasive procedure,
such as an arthroscopic procedure. Also, various aspects of the
invention may be used in any suitable surgical or other procedure
involving any suitable body portions, such as bone, muscle, skin,
vascular structures, digestive structures or other tissue,
implants, mesh, or other medical devices, etc. Aspects of the
invention may be used alone, and/or in combination with any other
aspects of the invention.
[0027] In another aspect of the invention, a needle used to place a
suture in a material, such as a rotator cuff tendon and/or implant,
may be engaged with a cannula, such as an arthroscopic cannula.
Thus, the needle may be operated to place the suture by
manipulating the cannula. The needle and cannula may have
complementary locking members or otherwise arranged so that the
needle may be selectively engaged with the cannula. Thus, the
cannula may be usable as a standard arthroscopic cannula, and if
needed, may be engaged with the needle. Thereafter, the needle and
cannula may be used to place the suture in the selected tissue.
[0028] FIG. 3 shows a schematic diagram of a surgical repair in
accordance with aspects of the invention. As discussed above,
although aspects of the invention are described with reference to a
rotator cuff repair for ease of reference and understanding,
aspects of the invention may be used in any surgical or other
procedure, and may involve any suitable body portions, such as
bone, muscle, other tissue or combinations thereof, the brain,
medical implants or other devices, etc. Thus, aspects of the
invention are in no way limited to the specific embodiments and
examples described herein.
[0029] In this illustrative embodiment, a rotator cuff tendon 2 is
secured by a suture 3 relative to a humerus 1. The suture 3 is
placed in the tendon 2, for example, using a mattress stitch or
other arrangement, and is passed through a passageway 5 formed
through the humerus 1. In this embodiment, the passageway 5 is
formed by first and second intersecting holes. A first hole 51 is
formed vertically as shown in FIG. 3 from a first opening at or
near a margin between the articulating surface 11 and the greater
tuberosity 12 of the humerus 1. The second hole 52 is formed
horizontally as shown in FIG. 3 from a lateral position on the
humerus 1. The suture 3 is secured at the second opening of the
second hole using a suture fixation device 4 that is positioned
adjacent the second opening. Although in this embodiment the first
and second holes 51 and 52 are arranged at approximately right
angles, the first and second holes may be arranged at any suitable
angle and may be colinear (i.e., at a 180 degree angle relative to
each other).
[0030] A wire, other material or the suture 3 may be manipulated in
the passageway 5 so as to cut through or crush the relatively soft
cancellous bone of the humerus in the passageway 5 so that the
suture follows a relatively straight path between the first and
second openings into the first and second holes 51 and 52. The
relatively straight pathway may be formed by a "flossing"
operation, such as by using a wire that is passed through the
passageway 5 and is manipulated, e.g., tensioned and reciprocally
drawn between the first and second openings, so as to cut through
or crush the cancellous bone, thereby forming a relatively straight
path for the suture 3.
[0031] When deciding where to locate the first hole 51 for the
passageway 5, a surgeon often will wish to first determine the
final position for the tissue relative to the bone. To do so, the
surgeon may wish to place a suture in the tendon 2 and tension the
suture 3 (and thus the tendon 2) so that a desired position for the
first hole 51 may be determined, e.g., based on the position of the
tendon 2 relative to the bone when under tension.
[0032] In one aspect of the invention, use of a needle having a
hook-shaped or curved end portion may be preferred. FIGS. 4-6 show
an embodiment of a needle 6 having a hook-shaped tissue penetrating
portion 61 at a distal end in accordance with the invention. In the
illustrated embodiment, the tissue penetrating portion 61 of the
needle 6 has a semi-circular shape and is arranged at an angle,
such as 90 degrees to a longitudinal axis of a straight portion 62
of the needle 6. The needle 6 may be formed as a hollow tube so
that the suture 3 may pass through the needle 6. Suture may be
loaded in the hollow portion of the needle 6 before the surgical
procedure is begun, e.g., at the time of manufacture of the needle,
or at any suitable time, such as during the surgical procedure. In
some cases, the suture may be fed into the hollow portion of the
needle 6 before the tissue penetrating portion 61 is formed, e.g.,
by bending a tube to form a curved end shape.
[0033] The arrangement of the needle 6 may allow placement of a
mattress stitch in the tissue 2 by rotating the needle as shown in
FIGS. 4-6 so that a tip of the tissue penetrating portion 61 passes
through a top side of the tissue 2 and exits from a bottom side of
the tissue 2 as shown in FIG. 5, and then passes upwardly through
the tissue 2 to reemerge at a top side of the tissue 2 as shown in
FIG. 6. At this point, the suture 3 extending from the tip of the
tissue penetrating portion 61 may be grasped, such as by forceps or
other gripping device, and the needle 6 may be rotated in reverse
so as to again position the needle 6 as shown in FIG. 4, thereby
leaving the suture 3 positioned in the tissue 2 to form a mattress
stitch. Of course, the needle 6 may be used to place a suture in
any material, including a tissue, such as a tendon as shown, a
prosthetic or other surgical implant, etc. During the passage of
the suture, the tissue or other material may be held in place, or
may be manipulated, by a grasper or other device inserted into the
lumen of the cannula. The tissue or other material may also be held
in place, or manipulated, by another device, such as a grasper or
clamp positioned external to the cannula.
[0034] The tissue penetrating portion 61 of the needle 6 may have
any suitable shape and may be arranged in a plane that is
transverse at any angle to an axis of rotation of the tissue
penetrating portion 61 when placing a suture in tissue. That is,
although in the illustrated embodiment the tissue penetrating
portion 61 has a semi-circular form that lies in a plane at 90
degrees to the rotation axis of the tissue penetrating portion 61
when placing a suture, the tissue penetrating portion 61 need not
have a semi-circular form and may lie at any desired angle to the
rotation axis. For example, the tissue penetrating portion 61 may
be arranged so as to place an inclined mattress stitch in a tissue
2. Further, the needle 6 need not be used only to form a mattress
stitch, but rather may be used to form any other suitable stitch
type. Also, it is not necessary that the tissue penetrating portion
61 of the needle 6 include a portion that lies in a single plane.
Instead, the tissue penetrating portion 61 may not lie in a single
plane, e.g., may have a corkscrew-type or partially helical
configuration.
[0035] In one aspect of the invention, all or portions of a tissue
repair procedure may be performed arthroscopically. In this case,
and as is known in the art, one or more cannulas may be provided in
one or more portals formed in the patient so as to provide access
to the operative site. In one aspect of the invention, a needle
used to place a suture in a tissue, such as the needle 6 shown in
FIG. 4, may be used in an arthroscopic procedure. For example, the
needle 6 may be secured to a cannula so that the needle may be
operated by manipulation of the cannula.
[0036] FIG. 7 shows an illustrative embodiment of a needle 6 that
is secured to a cannula 7. The cannula 7 may have any suitable
features found in cannulas used for closed or minimally-invasive
surgical techniques, such as one or more valves to resist fluid
flow through the cannula 7, an opening through which to introduce a
fluid pressure or vacuum, spiral threads or other features on the
cannula to aid in placement of the cannula in a portal and/or to
help prevent inadvertent removal of the cannula from the portal,
and so on. The cannula 7 may be arranged for any type of procedure,
such as arthroscopic procedures.
[0037] The needle 6 may be secured to the cannula 7 in any suitable
way. For example, the needle 6 may be molded into the body of the
cannula 7, inserted into the wall of the cannula, may be secured by
adhesive, welding, clamps, fasteners, interlocking channels, open
channels, or any other suitable device. A proximal end of the
needle 6 may terminate at any suitable point, such as midway
between a proximal end 71 and a distal end 72 of the cannula 7 as
shown, or, more preferably at a position proximal to the proximal
end 71. By having the proximal end of the needle 6 positioned
proximally of the cannula 7, a user may be better able to access
the suture 3 entering the proximal end of the needle 6. The needle
6 may also be axially movable relative to the cannula, e.g., so
that the tissue penetrating portion 61 may be moved axially so as
to extend away from or toward the distal end 72 of the cannula 7.
In addition, although the needle 6 is shown as positioned on an
outer surface of the cannula 7, the needle 6, or at least a portion
thereof, may be molded into the cannula 7, positioned within the
cannula lumen, positioned in the cannula wall, may be arranged
within a groove on the outer surface of the cannula, and so on.
Although the needle 6 is shown as arranged in an approximately
straight fashion along the length of the cannula 7, the needle 6
may be bent, curved or arranged in any suitable way, such as
following a spiral path around an outer surface of the cannula
7.
[0038] In one illustrative embodiment, a semicircular-shaped tissue
penetrating portion 61 of the needle 6 may be arranged relative to
the cannula 7 so that a centerpoint of the semicircle lies on a
central longitudinal axis 73 of the cannula lumen. Thus, when the
cannula 7 is rotated about the central longitudinal axis 73, the
tissue penetrating portion 61 may travel in a circular or
arc-shaped path about the axis 73. However, it should be understood
that the tissue penetrating portion 61 may be arranged in any
suitable way relative to the axis 73. Further, a plane in which the
tissue penetrating portion 61 lies (if present) may be arranged at
any angle transverse to the axis 73, and thus need not be arranged
at an angle of 90 degrees to the axis 73, as shown in FIG. 7.
[0039] In one aspect of the invention, the needle 6 may be
removeably engaged with the cannula 7 so that the needle 6 can be
selectively engaged or disengaged with the cannula 7. For example,
a cannula 7 may be positioned in a portal in use during a surgical
procedure without an attached needle 6. At some point during the
procedure, the surgeon may wish to attach a needle 6 to the cannula
7 and manipulate the cannula 7 so as to use the needle 6 to place a
suture in a material. The needle 6 may be secured to the cannula
while the cannula remains in place in the portal (e.g., by
inserting the needle 6 into the cannula lumen), or the cannula may
be removed from the portal, the needle attached, and the cannula
and attached needle inserted into the portal.
[0040] By attaching a needle to a cannula like that shown above,
the cannula lumen may remain available for use with other
instruments, such as an endoscope, grasper or other surgical
instrument. However, in some embodiments the cannula lumen may not
remain open for other use, such as if the needle is secured to a
cylindrical plug that is inserted into, and completely or partially
blocks, the cannula lumen when the needle is engaged with the
cannula.
[0041] FIG. 8 shows one illustrative embodiment in which a needle 6
may be removably secured to a cannula 7. In this embodiment, the
cannula 7 includes a dovetail-shaped groove 74 into which a
correspondingly shaped portion of the needle 6 is inserted. The
complementary locking arrangement used by the cannula 7 and the
needle 6 need not necessarily be dovetail-shaped as shown in FIG.
8, but rather may have any suitable arrangement. For example, the
cannula 7 may have an oval-shaped groove that extends into the wall
of the cannula 7, and the needle 6 may have a complementary oval
shape that engages with the groove. Thus, the needle 6 may be
selectively secured to the cannula 7 so that rotation (e.g., about
a longitudinal axis of the cannula lumen) or other manipulation of
the cannula 7 can cause the needle to be manipulated so as to place
a suture in a material. The complementary locking arrangement
between the needle 6 and the cannula 7 may also allow for axial
movement of the needle 6 relative to the cannula 7, e.g., so the
tissue penetrating portion 61 can be moved relative to the distal
end 72 of the cannula 7.
[0042] FIG. 9 shows an alternative embodiment in which a needle 6
is fixed to a sleeve member 63 that has one or more complementary
locking features that mesh with or otherwise engage with
complementary features on the cannula 7. In this embodiment, the
complementary locking features have a tooth-like or gear-like form,
but the complementary locking features may be arranged in any
suitable way. Accordingly, in this embodiment, the needle 6 may be
secured to the cannula 7 by sliding the sleeve 63 over the distal
end 72 of the cannula 7. It will be understood that rather than
having a sleeve 63 that fits over the cannula 7, the sleeve 63 may
fit within the internal lumen of the cannula 7, or within a slot in
the cannula 7, if desired.
[0043] Once a suture is placed in the tissue, such as a rotator
cuff tendon, the tissue may be tensioned to determine a location
for the opening of the first hole 51 to be formed in the bone. When
performing a rotator cuff repair, typically, a first hole 51 of the
passageway 5 will be formed vertically from a superolateral
position so that the first hole 51 is generally aligned along the
length of the humerus 1 and extends into the bone from an opening
formed at the margin between the articulating surface 11 and the
greater tuberosity 12. This first hole 51 may be formed using a
perforator, such as a drill, awl, punch or other suitable device.
As with other procedures performed, the first hole 51 may be formed
using an arthroscopic portal at a superolateral position, or may be
formed in an open surgical procedure.
[0044] In accordance with an aspect of the invention, a guide
apparatus may be used to form the first and/or second holes of the
passageway (e.g., used to locate a starting point or opening for
the first and second holes, used to orient a bone perforator when
making the holes, or used alone to form the first and/or second
holes), or may be used to help feed a suture or suture-like
material through the passageway. For example, a first guide member
81 may be secured relative to the first hole 51, as shown in FIG.
10. The first guide member 81 may be part of a guide apparatus 8
used to guide the formation of holes used to form a passageway in
bone and/or to pass a suture or other material through the
passageway. In the illustrated embodiment, the first hole 51 has
been formed in a vertical direction along the length of the humerus
1, e.g., by drilling the hole in a freehand manner. (Alternately,
the first hole 51 may be formed by forcing the first guide member
81 into the bone as with an awl or similar instrument.) The first
guide member 81 may include a feature to help secure the first
guide member 81 relative to the first hole 51, such as a threaded
distal end that allows the first guide member 81 to be screwed into
the bone to a desired depth in the first hole 51. It should be
understood, however, that the distal end of the first guide member
81 need not be threaded, but instead may unthreaded and inserted
into the first hole 51. Alternately, the distal end of the first
guide member 81 may be positioned outside of, but adjacent to, the
first hole 51 so that a lumen in the first guide member 81 aligns
with the first hole 51. The first hole 51 may be formed so as to be
deeper than thought to be needed, e.g., 0.5 cm deeper than a hole
depth believed to be required. This overdrilling of the first hole
51 may allow for more flexibility in positioning the first guide
member 81 to a desired depth in the bone.
[0045] The first guide member 81 may be arranged with respect to a
reference structure 83 used to position first and second guide
members 81 and 82 relative to each other with respect to the
passageway 5, as is discussed in more detail below. In this
illustrative embodiment, the reference structure 83 is arranged so
that the first and second guide members 81 and 82 are positioned at
a 90 degree angle relative to each other when engaged with the
reference structure 83. However, the reference structure 83 may be
arranged in any suitable way so as to orient the first and second
guide members 81 and 82 at any desired angle relative to each
other, including arranging the first and second guide members 81
and 82 in a co-linear fashion. Further, the reference structure 83
may be made so as to be adjustable, thereby allowing the
orientation of the first and second guide members 81 and 82 to be
changed. For example, the arc-shaped connecting portion of the
reference structure 83 may be made so as to be adjustable in
length, e.g., having one arc-shaped portion sliding relative to
another arc-shaped portion to allow adjustment of the length of the
connecting portion. Alternately, or in addition, engagement
portions 84 and 85 of the reference structure 83 that engage with
the first and second guide members 81 and 82 may be adjustable in
orientation relative to the arc-shaped connecting portion. In
short, the reference structure 83 may be arranged in any suitable
way so as to allow adjustment in the orientation of the guide
members 81 and 82.
[0046] In this illustrative embodiment, the engagement portions 84
and 85 include sleeves that receive at least a portion of the guide
members 81 and 82, e.g., the guide members 81 and 82 may be
received in bores in the sleeves. The sleeves may be arranged so
that the guide members 81 and 82 are movable linearly along their
longitudinal axes and rotationally about their longitudinal axes
relative to the engagement portions 84 and 85, but otherwise may be
relatively restricted in their range of movement. When a stop on
the first guide member 81, such as a knob 811 on the proximal end
of the guide member 81, contacts an engagement surface on the
reference structure, such as a portion of the engagement portion
84, the second guide member 82 may be positioned by the reference
structure 83 so that its longitudinal axis passes a point adjacent
the extreme distal end of the first guide member 81. Thus, the
second guide member 82 may be used to guide the use of a perforator
9 (such as a drill, punch, awl or other bone perforating device) so
that the perforator 9 forms a second hole 52 that intersects with
the first hole 51 at a location adjacent the distal end of the
first guide member 81. As discussed above, the guide member 82 may
guide the movement of the perforator 9, e.g., guide the movement of
a drill or punch inserted into a lumen of the guide member 82 as
shown, or may guide a starting location for forming the second
hole, e.g., be used to mark or otherwise determine a starting
location for the perforator 9, but otherwise not interact with the
perforator 9. By adjusting the depth of the first guide member 81
in the first hole 51, the location where the second hole 52 is
formed can be adjusted in position (e.g., in a vertical direction
as shown in the figures). For example, by screwing the first guide
member 81 into or out of the first hole 51, a surgeon may select a
location where the second hole 52 is to be formed in the bone.
[0047] In another embodiment, the engagement portion 85 may itself
function as a perforator guide with the second guide member 82
being withdrawn from the engagement portion 85. Although in this
illustrative embodiment the engagement portions 84 and 85 are shown
as relatively short cylindrical sleeves, the engagement portions 84
and 85 may be arranged in any suitable way, e.g., may be elongated
so as to more closely approach the humerus 1 and provide improved
guidance for a perforator 9 and/or the first and second guide
members 81 and 82. Further, the first guide member 81 may be
arranged so that is rotationally movable about its longitudinal
axis relative to the reference structure 83, but is otherwise held
by the engagement portion 84 so that the first guide member 81 is
not movable axially. This may aid is appropriately positioning the
first guide member 81 and reference structure 83 when forming the
second hole 52.
[0048] Upon formation of the second hole 52, the second guide
member 82 may be screwed into the second hole 52 until a stop on
the second guide member 82, such as a knob 821 at a proximal end of
the guide member 82, contacts an engagement surface on the
engagement portion 85, such as a portion of the sleeve. In this
configuration shown in FIG. 11 (stops on the first and second guide
members 81 and 82 engaged with respective engagement surfaces on
the reference structure 83), the extreme distal ends of the first
and second guide members 81 and 82 may be adjacent to each other in
the passageway 5 formed by the first and second holes 51 and 52.
Accordingly, a surgeon may be assured that if the first and second
guide members 81 and 82 are positioned within the bone and stops on
the guide members 81 and 82 are respectively in contact with
appropriate engagement surfaces on the guide apparatus 8, the
extreme distal ends of the guide members 81 and 82 will be
positioned adjacent each other. Thus, the surgeon may be assured
that a wire 10 or other element may be fed into one of the guide
members and retrieved from the other of the guide members, e.g.,
using a retriever 21 having a hook at a distal end. Such an
arrangement may be advantageous when using the guide apparatus 8 in
an arthroscopic procedure where the operative site may not be
easily visualized.
[0049] Although in the above embodiment, stops on the first and
second guide members 81 and 82 contact corresponding engagement
surfaces on the engagement portions 84 and 85, the guide members 81
and 82 may be positioned relative to the reference structure 83 in
any suitable way. For example, the guide members 81 and 82 may have
indicator marks on them that may be aligned with a portion of the
engagement portions 84 and 85, respectively. The alignment of
certain indicator marks on the guide members 81 and 82 may be used
to indicate, for example, that the distal ends of the guide members
81 and 82 are adjacent each other. Those of skill in the art will
understand that the position of the guide members 81 and 82
relative to the reference structure 83 and relative to each other
may be determined in other ways. For example, the first and second
guide members 81 and 82 need not necessarily be positioned so that
their distal ends are adjacent in the passageway to assist in
feeding a suture from one guide member to the other. Instead, the
first and second guide members 81 and 82 may be made to suitably
communicate with the passageway in any way so as to facilitate
feeding of the suture.
[0050] In this illustrative embodiment, the first guide member 81
is shown as having a smaller diameter (at least at the distal end)
than the second guide member 82. This may allow the guide apparatus
8 to be used with an arrangement where the first hole 51 is smaller
than the second hole 52. A relatively small first hole 51 may allow
for more rapid healing and/or provide additional space for other
holes in the margin, if needed. However, it should be understood
that the guide apparatus 8 and/or the holes that form the
passageway 5 may be made in any suitable way, e.g., the first and
second holes 51 and 52 may have the same diameter or the first hole
51 may have a larger diameter than the second hole 52.
[0051] The guide apparatus 8 may also include additional guide
members if desired, e.g., to provide for the formation of a third
hole that is formed in the margin and is approximately parallel to
the first hole 51, but also intersects with the second hole 52.
Similarly, the guide apparatus 8 may include two pairs of guide
members like that in the illustrative embodiment that are arranged
to form side-by-side passageways 5 in the bone or other body
portion.
[0052] Although in this illustrative embodiment, the guide
apparatus 8 is used to guide the formation of the second hole 52,
the guide apparatus 8 need not necessarily be used to guide the
formation of the second hole 52. That is, the guide apparatus 8 may
be used only to help feed the wire 10, suture or other material
through a passageway that is pre-formed in the bone or other body
portion. In addition, the first and second guide members 81 and 82
may be arranged so that the members 81 and 82 can be secured in a
body portion without requiring holes to be predrilled or otherwise
formed. Thus, in one embodiment, the first and second guide members
81 and 82 may be arranged like an awl or other device capable of
forming a hole in a body portion, e.g., capable of being forced
into bone, forming the passageway 5 by their entry and/or providing
a means to help feed a wire, suture or other material through the
passageway 5.
[0053] Once the wire 10, suture or other material has been passed
through the passageway 5, as shown in FIG. 12, the wire 10 may be
used to pull the suture 3 through the passageway 5. Prior to being
used to pull the suture 3 through the passageway 5, the wire 10 or
other material may be used to create a relatively straight pathway
for the suture 3 once the suture 3 is tensioned and fixed in place.
For example, the wire 10 may be tensioned between the first and
second openings 53 and 54 of the first and second holes 51 and 52
or otherwise manipulated so as to cut or crush the body portion,
e.g., bone, between the first and second openings 53 and 54. Such
manipulation of the wire 10 may perform a kind of "flossing" effect
in the bone, allowing the suture 3 to follow a more straight
pathway through the passageway 5, reducing the length of suture 3
needed between the rotator cuff2 and a point of fixation of the
suture 3, e.g., near the second opening 54. The wire 10 may have
barbs or other saw-like features to aid in cutting bone and forming
the pathway. Of course, the more straight pathway could be formed
by manipulating the suture 3 itself, e.g., by tensioning the suture
3 when securing the tendon or other material. Reducing the length
of suture 3 in the passageway 5 may improve the suture's ability to
maintain appropriate tension on the rotator cuff 2, e.g., by
reducing the amount of stretch of the suture when under
tension.
[0054] After the suture 3 has been passed through the passageway 5,
the suture 3 may be engaged with a suture fixation device 4 as
shown in FIG. 13. Although use of a suture fixation device is not
required, the suture fixation device 4 may improve an ability to
securely fixate the suture 3 (and the tissue 2) relative to the
bone. The suture fixation device 4 may be arranged in any suitable
way, but in this illustrative embodiment has an arrangement similar
to a button. For example, the suture fixation device 4 may have two
through holes formed in a disk-shaped member through which leading
ends of the suture 3 are passed. The suture ends 3 may be passed
through respective holes in the suture fixation device 4 using one
or more feed members 41. The feed members 41 may have an elongated
shape that is passed through a respective hole in the suture
fixation device 4. A loop at one end of the feed member 41 may
receive an end of the suture 3 and thereafter the feed member 41
may be pulled through a respective hole in the suture fixation
device 4 so as to pull the suture 3 through the hole. Of course, it
should be understood that the suture 3 may be fed through the
suture fixation device 4 in any other suitable way. When performing
this technique arthroscopically, the suture 3 may be fed through
the suture fixation device 4 either inside or outside of the body
cavity.
[0055] As shown in FIG. 14, after the suture 3 is engaged with the
suture fixation device 4, the suture fixation device 4 may be
positioned relative to the second opening 54 of the passageway 5
using an applier 42 which removably engages with the suture
fixation device 4 and may be selectively disengaged from the suture
fixation device when the suture fixation device 4 is positioned as
desired. As shown in FIG. 15, the applier 42 may have a pair of
tines 421 that engage with recesses or other features on the suture
fixation device 4 so as to removably engage with the suture
fixation device 4. The tines 421 may be resilient so that the tines
are squeezed together when engaged with the suture fixation device
4. Thus, an elastic force biasing the tine ends apart may help
maintain engagement of the tines with the grooves 48 in the suture
fixation device 4. Alternately, the tine ends may be force-fit into
grooves 48 in the suture fixation device so that engagement is
maintained based on friction. Of course, it will be understood that
the applier 42 may engage with the suture fixation device 4 in any
other suitable way, such as a screw-in or snap configurations.
[0056] With the suture fixation device 4 in place relative to the
second opening 54, the suture 3 may be tensioned so as to
appropriately position the rotator cuff2 relative to the humerus 1.
At this point, the suture 3 may be fixed relative to the suture
fixation device 4, such as by tying a knot with the suture ends.
Thus, the suture fixation device 4 may provide not only a structure
to support the suture knot, but also may spread the force of the
suture 3 to portions of the relatively hard cortical bone
surrounding or otherwise adjacent to the second opening 54. By
having the suture fixation device 4 engage with this cortical bone,
the suture fixation device 4 may provide a relatively stable and
secure fixation point for the suture 3. The suture fixation device
4 may also incorporate a mechanism for knotless fixation of the
suture, such as an interference pin, a locking passageway, a
locking cap, etc.
[0057] Although in the illustrative embodiment described above both
ends of the suture 3 are passed through the passageway 5 and
secured at or near the second opening 54 of the passageway 5, the
suture 3 may be secured in other ways, such as by passing one end
of the suture 3 through the passageway 5 and passing another end of
the suture 3 around the outside of the bone (e.g., over a portion
of the greater tuberosity) where it is secured to the other suture
end. In another embodiment, two passageways 5 may be formed through
the bone and one end of the suture 3 may be passed through one
passageway and the other end of the suture 3 may be passed through
the other passageway. The suture ends may then be secured to each
other at or near respective second openings of the passageways 5 on
the lateral side of the humerus 1. In yet another embodiment, two
or more first holes 51 may be formed so as to intersect with one or
more second holes 52. Suture 3 may be passed through the two or
more first holes 51 and be secured at the second opening 54 of the
one or more second holes 52. Such an arrangement may allow for the
use of a single second hole 52 and suture fixation device 4 to
secure the rotator cuff at two or more points on the humeral head
using two or more sutures that pass through different first holes
51. Other suture fixation techniques may be used as desired.
[0058] FIGS. 16A-B and 17A-B show illustrative embodiments of
suture fixation devices 4 in accordance with the invention. In
these embodiments, the suture fixation device 4 includes a
restriction in a pathway through the suture fixation device 4 so
that suture or other material passing through the suture fixation
device is relatively freely moved in one direction through the
pathway, but movement of the suture or other material in the other
direction in the pathway is resisted. For example, movement of a
suture though the suture fixation devices shown in FIGS. 16A and
17A in a direction to the left in the side view of the suture
fixation devices 4 may be freely allowed, while movement of the
suture toward the right may be resisted. This may aid in tensioning
the suture 3 because the suture 3 may be pulled from the second
hole 52 through the suture fixation device 4 until the rotator cuff
or other tissue is appropriately positioned. Thereafter, tension on
the suture may be temporarily released, e.g., in preparation for
forming a knot, but movement of the suture back through the suture
fixation device 4 may be resisted so that the rotator cuff or other
tissue is maintained in place until the suture knot is tied or
otherwise is secured.
[0059] In the FIG. 16A-B embodiment, the suture fixation device
includes an outer end having a flange portion 43 that is sized and
arranged to contact the cortical bone adjacent the opening in the
passageway at which the suture fixation device 4 is positioned,
e.g., the second opening 54. One or more pathways 44 may be formed
through the suture fixation device 4, such as by a hole or holes
formed through the flange 43 (see also FIG. 15). Instead of having
multiple holes, the pathway 44 may include a single slot arranged
to receive one or more sutures. A recess 49 may be provided in the
flange portion 43 to receive one or more knots, if formed with the
suture(s) in the pathway 44. A pair of duck bill members 45 at an
inner end of the suture fixation device 4 may extend rearwardly
from the flange 43 and may be arranged as to be positionable in the
second hole 54. The duck bill members 45 may be separated from each
other by a groove that extends across the inner end of the suture
fixation device 4 and be resiliently biased toward each other so as
to resist the passage of suture or other material through the
pathway 44. One or both of the duck bill structures 45 may include
serrations 46 or other features that may aid in engaging a suture
or other material. In the FIG. 16 embodiment, the groove separating
the duck bill structures 45 extends to the flange portion 43 so
that the structures 45 are pivotable at a point near the flange
portion 43.
[0060] The FIG. 17A-B embodiment similarly includes a flange 43 and
one or more pathways 44. Duck bill structures 45 are also provided.
However, in this embodiment rather than being hinged at a point
near respective connection points with the flange 43, the duck bill
portions 45 are hinged at a point positioned away from the flange
43. Providing the effective hinge points for the duck bill
structures 45 in this manner may provide improved engagement of the
duck bill structures 45 with a suture or other material when the
suture is urged to move from the outer end toward the inner end
through the pathway 44. That is, if the suture is pulled to move
toward the inner end, serrations 46 or other features will engage
with the suture and increased force on the suture will cause an
increased force urging the duck bill structures 45 to move toward
each other and further squeeze the suture. The duck bill structures
in the FIG. 16 and 17 embodiments or other suitable suture
engagement arrangements (such as interference pins, locking caps,
etc.) may provide a knotless fixation for the suture.
Alternatively, the structures may resist movement of the suture so
as to aid the surgeon's ability to maintain tension on the suture
while forming a knot.
[0061] Although this embodiment depicts the flange of the device
resting on the outer cortical surface of the bone, the device may
be positioned in a hole which has a counterbore, or countersink, in
order to prevent any interference between the flange and other bone
or tissues that may come in contact with the site either at rest or
during movement. Even in the case where the device is positioned in
a counterbore or countersink feature, the device may contact
cortical bone. Alternately, the device may only contact the outer,
cortical surface of the bone, and not extend into a hole in the
bone.
[0062] Of course, it should be understood that suture fixation
devices may be provided in any suitable form. For example, the duck
bill portions 45 extending from the flange 43 in the FIGS. 16 and
17 embodiments may be sized to closely fit into a mating hole
formed in bone. This close fit may help in maintaining the suture
fixation devices 4 in a desired position in the bone. Alternately,
the duck bill structures 45 may be formed so as to be tapered on
their outer surfaces. Thus, when the suture fixation device 4 is
inserted into a hole in the bone, the tapered surfaces of the duck
bill structures 45 may contact the sides of the hole and urge the
duck bill structures to move toward each other as the suture
fixation device 4 is pressed into the hole. In another embodiment,
a portion of the suture fixation device 4 that is inserted into a
hole may be threaded or otherwise be arranged so as to engage the
hole and help prevent the suture fixation device from falling from
the hole, e.g., before the suture is secured in place. There are
many variations of the mechanism form to retain the suture with
respect to the device. Some of these forms may require a knot for
final fixation. Other capturing mechanisms may provide sufficient
locking of the suture such that a knot is not required. Theses are
typically known as "knotless" devices.
[0063] Having thus described several aspects of at least one
embodiment of this invention, it is to be appreciated various
alterations, modifications, and improvements will readily occur to
those skilled in the art. Such alterations, modifications, and
improvements are intended to be part of this disclosure, and are
intended to be within the spirit and scope of the invention.
Accordingly, the foregoing description and drawings are by way of
example only.
* * * * *