U.S. patent application number 10/815338 was filed with the patent office on 2004-12-09 for compact suture punch with malleable needle.
This patent application is currently assigned to Arthrex, Inc.. Invention is credited to Morris, John K., Van Wyk, Robert A..
Application Number | 20040249394 10/815338 |
Document ID | / |
Family ID | 34592716 |
Filed Date | 2004-12-09 |
United States Patent
Application |
20040249394 |
Kind Code |
A1 |
Morris, John K. ; et
al. |
December 9, 2004 |
Compact suture punch with malleable needle
Abstract
A suture punch system that is capable of directly passing
braided suture through tissue in a simple, one-step process. The
system includes three principle components: a malleable needle
capable of delivering the suture to the tissue, a handheld
instrument for grasping tissue and controlling needle placement,
and a force-supplying mechanism to supply the force required for
needle placement. Needle deformation begins at the tip of the
instrument, which beneficially includes a curved segment. As the
distal tip of the needle pierces the tissue, it continues its
radial path through the tissue. When the proximal end of the needle
exits from the instrument, the needle may be radial in shape and
traverses an essentially radial path through the tissue. Non-radial
linear or non-linear segments may alternatively be used. In one
embodiment, the tissue to be sutured is constrained by pressure
applied through closure between an upper, moveable jaw at the
distal portion of the instrument, which acts as a fixed jaw. The
upper, movable jaw contains a shaped passageway that permits the
needle to pass therethrough during use. Once the needle has passed
entirely through the tissue it may be retrieved using the jaws of
the punch or another instrument. Different needle designs and
separate instruments and sutures may be used.
Inventors: |
Morris, John K.; (Ann Arbor,
MI) ; Van Wyk, Robert A.; (Largo, FL) |
Correspondence
Address: |
AKERMAN SENTERFITT
P.O. BOX 3188
WEST PALM BEACH
FL
33402-3188
US
|
Assignee: |
Arthrex, Inc.
Naples
FL
|
Family ID: |
34592716 |
Appl. No.: |
10/815338 |
Filed: |
April 1, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
10815338 |
Apr 1, 2004 |
|
|
|
10165468 |
Jun 7, 2002 |
|
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60310220 |
Aug 6, 2001 |
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Current U.S.
Class: |
606/144 ;
606/222 |
Current CPC
Class: |
A61B 17/29 20130101;
A61B 17/06066 20130101; A61B 17/0469 20130101; A61B 17/06061
20130101; A61B 17/0482 20130101; A61B 17/062 20130101; A61B
2017/2926 20130101; A61B 2017/06028 20130101; A61B 2017/0496
20130101; A61B 2017/00946 20130101; A61B 17/0625 20130101 |
Class at
Publication: |
606/144 ;
606/222 |
International
Class: |
A61B 017/04 |
Claims
We claim:
1. Suturing instrumentation for suturing tissue comprising: a
malleable needle portion having a sharpened distal tip and
constructed and arranged to deliver a length of suture material to
the tissue; a handheld instrument having a passageway and having a
distal end terminating in a nonlinear portion having a first
radius; and a force-supplying structure configured for applying a
force to the needle portion, wherein the force-supplying structure
includes a distal end capable of pushing the malleable needle
portion through the nonlinear portion, such that when the distal
end of the handheld instrument is positioned proximate to the
tissue to be sutured and the malleable needle portion is pushed by
the distal end of the force-supplying structure through the
nonlinear portion, the needle portion is deformed, thereby causing
the needle portion to deliver the suture material to the
tissue.
2. The suturing instrumentation of claim 1, wherein the handheld
instrument includes a proximal insertion opening to receive the
distal end of the force-supplying structure.
3. The suturing instrumentation of claim 1, wherein the distal end
of the handheld instrument includes an elongated slot to receive
the malleable needle portion from the side, the slot transitioning
to a narrower slit along the nonlinear portion, enabling the suture
material to extend from the slit as the needle portion is pushed
through the nonlinear portion.
4. The suturing instrumentation of claim 1, wherein the malleable
needle portion has a degree of spring back of from 0 to about 100
percent.
5. The suturing instrumentation of claim 4, wherein the malleable
needle portion has a degree of spring back of from 0 to about 10
percent.
6. The suturing instrumentation of claim 4, wherein the malleable
needle portion has a degree of spring back of from about 90 to
about 100 percent.
7. The suturing instrumentation of claim 1, wherein the malleable
needle portion comprises a Nitinol needle.
8. The suturing instrumentation of claim 7, wherein the Nitinol
needle is formed into a curved shape having a radius substantially
equal to the first radius, further wherein the Nitinol needle is
forcibly straightened when located in the handheld instrument and
substantially regains the curved shape after leaving the handheld
instrument.
9. The suturing instrumentation of claim 7, wherein the Nitinol
needle is substantially linear in shape, further wherein the
Nitinol needle is forcibly curved when forced through the nonlinear
portion of the handheld instrument and substantially regains the
linear shape after leaving the handheld instrument.
10. Suturing instrumentation for suturing tissue comprising: a
malleable needle portion having a sharpened distal tip and
constructed and arranged to deliver a length of suture material to
the tissue; a handheld instrument having a passageway and having a
distal end terminating in a nonlinear portion having a first
radius; and a force-supplying structure configured for applying a
force to the needle portion, wherein the force-supplying structure
includes a distal end capable of pushing the malleable needle
portion through the nonlinear portion, such that when the distal
end of the handheld instrument is positioned proximate to the
tissue to be sutured and the malleable needle portion is pushed by
the distal end of the force-supplying structure through the
nonlinear portion, the needle portion is deformed, thereby causing
the needle portion to deliver the suture material to the tissue;
and a jaw pivotally coupled to the distal end of the handheld
instrument for holding tissue as the needle portion and suture
material enters into the tissue.
11. The suturing instrumentation of claim 10, wherein the jaw
includes an aperture, slot, or cavity to receive the deformed
needle portion.
12. The suturing instrumentation of claim 10, wherein the handheld
instrument includes a proximal insertion opening to receive the
distal end of the force-supplying structure.
13. The suturing instrumentation of claim 10, wherein the distal
end of the handheld instrument includes an elongated slot to
receive the malleable needle portion from the side, the slot
transitioning to a narrower slit along the nonlinear portion,
enabling the suture material to extend from the slit as the needle
portion is pushed through the nonlinear portion.
14. The suturing instrumentation of claim 10, wherein the malleable
needle portion has a degree of spring back of greater than 0 to
about 100 percent.
15. The suturing instrumentation of claim 14, wherein the malleable
needle portion has a degree of spring back of greater than 0 to
about 10 percent.
16. The suturing instrumentation of claim 14, wherein the malleable
needle portion has a degree of spring back of from about 90 to
about 100 percent.
17. The suturing instrumentation of claim 10, wherein the malleable
needle portion comprises a Nitinol needle.
18. The suturing instrumentation of claim 17, wherein the Nitinol
needle is formed into a curved shape having a radius substantially
equal to the first radius, further wherein the Nitinol needle is
forcibly straightened when located in the handheld instrument and
substantially regains the curved shape after leaving the handheld
instrument.
19. The suturing instrumentation of claim 17, wherein the Nitinol
needle is substantially linear in shape, further wherein the
Nitinol needle is forcibly curved when forced through the nonlinear
portion of the handheld instrument and substantially regains the
linear shape after leaving the handheld instrument.
20. The suturing instrumentation of claim 10, further including a
manually operated control enabling a user to open and close the
jaw.
21. A suture needle adapted for use with a handheld instrument
defining an axis and having an off-axis distal end, the needle
comprising: a length of material having a sharpened distal tip and
constructed and arranged to deliver a length of suture material;
and the material of the needle being malleable, such that when the
needle is pushed through the handheld instrument, it elastically
deforms in accordance with the off-axis distal end.
22. The suture needle of claim 21, wherein the length of material
includes one or more flat sides to resist rotation as the needle
passes through the off-axis portion of the handheld instrument.
23. The suture needle of claim 22, wherein the length of material
includes opposing flat sides.
24. The suture needle of claim 21, wherein the length of material
includes one or more indented portions to assist with deformation
as the needle passes through the off-axis portion of the handheld
instrument.
25. The suture needle of claim 21, wherein the length of the needle
is about 15 mm or less.
26. A suturing system comprising: a malleable needle portion having
a sharpened distal tip and constructed and arranged to deliver a
length of suture material; a handheld instrument having a
passageway and having a distal end terminating in a nonlinear
portion; and a push member configured for movement in the
passageway of the handheld instrument, the push member being
operative to push the malleable needle portion through the
nonlinear portion, such that when the distal end of the handheld
instrument is positioned proximate to a tissue to be sutured and
the needle portion is pushed by the push member through the
nonlinear portion, the needle portion is deformed and enters into
the tissue and delivers the suture material to the tissue being
sutured.
27. The suturing system of claim 26, wherein the needle portion is
substantially straight when in at least a portion of the
passageway, curved when in the distal end, and curved upon exiting
the distal end of the handheld instrument.
28. The suturing system of claim 26, wherein the needle portion is
substantially straight when in at least a portion of the
passageway, curved when in the distal end, and substantially
straight upon exiting the distal end of the handheld
instrument.
29. The suturing system of claim 26, wherein the malleable needle
portion has a degree of spring back of greater than 0 to about 100
percent.
30. The suturing system of claim 29, wherein the malleable needle
portion has a degree of spring back of greater than 0 to about 10
percent.
31. The suturing system of claim 29, wherein the malleable needle
portion has a degree of spring back of from about 90 to about 100
percent.
32. The suturing system of claim 26, wherein the malleable needle
portion comprises a Nitinol needle.
33. A method for suturing, comprising the steps of: providing a
malleable needle portion having a sharpened distal tip; positioning
the needle portion in a passageway of a handheld instrument;
providing a suture material to be delivered by the needle portion;
and using a push member to push the needle portion in the handheld
instrument, the needle portion upon exiting the handheld instrument
penetrating the tissue being sutured and delivering the suture
material to the tissue being sutured.
34. The method of claim 33, wherein the handheld instrument has a
distal end terminating in a nonlinear portion, and the needle
portion is deformed as it traverses the nonlinear portion.
35. The method of claim 33, wherein the needle portion is
substantially straight when in at least a portion of the passageway
of the handheld instrument, curved when in the distal end, and
curved upon exiting the distal end of the handheld instrument.
36. The method of claim 33, wherein the needle portion is
substantially straight when in at least a portion of the passageway
of the handheld instrument, curved when in the distal end, and
substantially straight upon exiting the distal end of the handheld
instrument.
37. The method of claim 33, wherein the malleable needle portion
has a degree of spring back of greater than 0 to about 100
percent.
38. The method of claim 37, wherein the malleable needle portion
has a degree of spring back of greater than 0 to about 10
percent.
39. The method of claim 37, wherein the malleable needle portion
has a degree of spring back of from about 90 to about 100
percent.
40. The method of claim 33, wherein the malleable needle portion
comprises a Nitinol needle.
Description
REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part application of
U.S. patent application Ser. No. 10/165,468, filed Jun. 7, 2002,
which claims priority to U.S. Provisional Patent Application Ser.
No. 60/310,220, filed Aug. 6, 2001.
FIELD OF THE INVENTION
[0002] This invention relates generally to surgical suturing and,
in particular, to improved articles, instrumentation, and methods
therefore.
BACKGROUND OF THE INVENTION
[0003] Suture passing is problematic for the arthroscopic surgeon
because the braided suture preferred by most arthroscopists cannot
be pushed through a cannulated instrument. Braided suture must be
pulled into location because applying a push force causes the braid
to expand in diameter, thereby wedging in the instrument.
[0004] Various solutions have been devised for passing braided
suture. The Caspari Suture Punch (Linvatec Corporation, Largo,
Fla.) has been a very useful arthroscopic suture-passing
instrument. Tissues may be approached head on, grasped and
punctured with a cannulated needle, then monofilament suture
wheeled through the tissue. A doubled monofilament may be used as a
shuttle to pass another braided suture or, alternatively, a
Linvatec Suture Shuttle may be wheeled through a slotted Caspari
Suture Punch and used to shuttle suture. Surgical Dynamics has a
similar device that shuttles a needle from one side of the punch to
the other, passing the needle and attached thread through
tissue.
[0005] The Caspari suturing instrument, described in U.S. Pat. Nos.
4,890,615, 4,923,461 and 4,957,498, includes a hollow needle for
penetrating tissue to be sutured within the body while the tissue
is clamped between relatively movable jaws, and a suture feed
mechanism for feeding suture material through the hollow needle
such that the jaws may be opened and the suturing instrument
withdrawn from the body pulling the free end segment of the suture
material with the instrument. A knot may be tied in the suture
material externally of the body and the knot moved back into the
body at a position adjacent the tissue.
[0006] U.S. Pat. No. 5,254,126 discloses an endoscopic suture punch
for use in endosurgical procedures having an elongate frame and a
handle mounted to one end of the frame. A pair of opposed jaws
having tissue punches is mounted to the other end of the frame. One
jaw is rigidly mounted to the frame while the other jaw is movably
mounted to the frame, although both jaws may be movably mounted. An
actuation handle is mounted to the frame for actuating the jaws.
The suture punch has a suture pathway through the frame, the
punches and the jaws for receiving the suture. There is a suture
drive mechanism mounted to the frame for moving the suture through
the suture pathway.
[0007] The surgical suturing apparatus described in U.S. Pat. No.
5,454,823 comprises upper and lower jaw elements selectively
movable relative to one another between open and closed position.
Each jaw element is provided with a respective recess arranged to
receive a portion of an elongate incision member or length of
surgical thread and securing means is provided arranged to
selectively secure the surgical incision member or length of
surgical thread in a respective recess. The jaw elements are
typically provided at an end of an elongate positioning and
operating arm making the device particularly useful for use in
laparoscopic surgery.
[0008] More recently, U.S. Pat. No. 6,051,006 describes a
suture-passing forceps having a first jaw with a mount which
supports a needled suture and a second jaw having a passage, which
when aligned with the mount, is positioned to receive the needled
suture. The second jaw is positioned relative to the mount in a
manner which allows delivery of the instrument to a surgical site
in a low profile, delivery position (e.g., with the jaws spaced
relatively closely). The surgical instrument includes an elongated
shaft having a distal region for supporting the jaws. The second
jaw is pivotable, with respect to the mount, between the delivery
position in which the second jaw is spaced relatively closely to
the mount with the passage misaligned with the mount and an open,
misaligned position, the second jaw being axially translatable
relative to the mount to an open, aligned position in which the
passage is aligned with the mount.
[0009] A shortcoming of these and other such devices is the lack of
room available to open the jaws sufficiently in tight spaces (a
clearance issue), difficulty in forcing the tooth through the full
thickness of the tissue (the tip gradually dulls and some tissue
like the rotator cuff is just too thick) and fairly large diameter
cannulas are required for passage.
[0010] Other "blitzes" and similar devices also have rather large
diameter cannulated needles that pierce the tissue then deploy a
loop or other mechanism to transport suture through the tissue.
These are cumbersome to use, often requiring skillful rotation and
pushing of the device by the surgeon to accomplish the selected
result. Additionally, some concern exists with regard to the size
of the hole placed in the tissue and the amount of damage requiring
repair. This is especially true of the newer "Arthropierce"
instrument currently in use.
[0011] Common to existing devices is a body capable undergoing
elastic deformation during use but which retains a preformed shape
when in an unconstrained condition. Of particular usefulness in
these devices is Nitinol, a so-called "shape retention" alloy
having an extremely high yield point. Nitinol components are formed
during manufacture to a selected shape, and will return to this
shape when in an unconstrained condition even after undergoing
significant deformation. Preformed Nitinol needles and shuttles may
be passed through cannulated instruments and will return to their
original shapes when in an unconstrained state. This allows shuttle
loops to be passed through cannulated instruments without permanent
deformation. All Nitinol components may be formed to their selected
shapes during manufacture.
[0012] As an example of an invention utilizing this effect, U.S.
Pat. No. 5,607,435 describes a medical instrument including a
tubular section having a leading end terminating in a sharp point
and a surgical needle exhibiting "superelastic characteristics." As
such, the needle may remain straight as it is inserted through the
delivery tube without developing substantial permanent deformation.
While in the delivery tube and in this substantially straight
condition, the needle is delivered to the suturing site. Once at
the suture site, the surgical needle is extended out of the leading
end of the delivery tube, returning it to its original curved or
bent shape for suturing. A suture thread or wire is operatively
disposed in the bore of the tubular section with one end extending
out the tip through a slot so as to remain in position to form a
suture upon removal of the tubular needle from tissue. A tweezers
instrument may then be used to grip and tie the thread into a
suture knot.
[0013] Similarly, U.S. Pat. No. 5,749,879 discloses a cannulated
instrument for use in conjunction with "an elastic needle." In the
preferred embodiment, the needle is of a pseudoelastic shape memory
alloy and has an arced shape while the needle's alloy is in a
substantially austenitic phase, and the needle may be stressed into
a more straight shape in which the needle's alloy enters an at
least partially more martensitic phase. When the needle is held
entirely within the cannula, the needle is straightened and
contains more stress-induced-martensite phase. As the needle is
extruded from the distal end portion of the cannula, that portion
of the needle which extends beyond the cannula returns toward its
original shape by a martensitic-to-austenitic shape memory phase
change caused by at least partial relief of the
stress-induced-martensite in the needle's alloy. A cannula insert
includes a longitudinal bore which may be used to contain a suture
attached to the needle. Suitably, the bore may extend
longitudinally entirely through the cannula insert, to permit an
unlimited length of suture to be pulled therethrough.
[0014] Despite these advances, the need remains for a suture punch
capable of passing braided suture without the use of a shuttle or
similar means. Beneficially, such an instrument would be capable of
passing suture while not requiring multiple or complex sequential
operations or a high level of surgeon skill. In other embodiments,
it would also be beneficial that the suture punch pass through a
small diameter (i.e., 8 mm or less) cannula, and that the hole
created in the tissue for passage of the suture be as small as
possible.
SUMMARY OF THE INVENTION
[0015] This invention overcomes deficiencies in the prior art by
providing a suture punch system capable of directly passing suture
material, such as braided suture material, through tissue in a
simple, one-step process. The system includes three principle
components: a malleable needle capable of delivering the suture
material to the tissue, a handheld instrument for grasping tissue
and controlling needle placement, and a trocar or other mechanism
to supply the force required for needle formation and
placement.
[0016] The needle differs from standard needles in terms of size,
shape and material properties. In beneficial embodiments, the
needle is shorter than standard needles, generally 10 to 13 mm in
length, and has a cross-section which may be circular or
non-circular, including rectangular with at least two parallel
sides. The rectangular needles may have varying thicknesses and
have a cross-section that ranges from substantially square to
substantially flat. Additionally, the needle is made of a malleable
material permitting it to be shaped within the handheld instrument
and to retain its form while passing through tissue. The needle may
also return to its form after passing through the tissue or once
any bending force has been removed. Similarly, the distal portion
of the trocar may be malleable, thereby permitting shaping within
the handheld instrument.
[0017] In contrast to existing suture punches in which the needle
or shuttle undergoes only an elastic deformation during use and the
functional un-constrained shape of the needle or shuttle is
produced during manufacture, the needle of the disclosed device may
be inelastically formed to its functional shape during use,
allowing the needle to traverse a nonlinear path. More
particularly, when passing through the distal tip of the hand
instrument, the needle may be inelastically formed by a radial path
within the instrument, the plane of the radius being substantially
unparallel to the tissue through which the suture is being passed.
The formation of this radius is facilitated by the aforementioned
parallel sides of the needle cross-section which are constrained by
the instrument in such a manner as to place them essentially in the
plane of the tissue.
[0018] Needle deformation begins as the tip of the needle passes
through the radius within the instrument and continues as the
needle is forced distally by a force-supplying mechanism. As the
distal tip of the needle pierces the tissue, it continues its
radial path through the tissue, the radius of the path being
determined by the unconstrained radius of the needle. This
unconstrained radius may be larger than that of the forming radius
within the instrument due to "spring back" of the needle, the
degree of which is determined by the material properties of the
needle, its cross section, and features formed in the parallel
surfaces of the needle during manufacture.
[0019] Forming of the needle along its length continues as it is
passes from the distal tip of the instrument into the tissue. When
the proximal end of the needle exits from the instrument, the
needle may be entirely radial in shape and traverse an essentially
radial path through the tissue. Due to the degree of spring back,
the needle, in certain embodiments, may also return to its
non-deformed shape. As used herein, the term "spring back" is meant
to define the degree of elasticity of the malleable needle after it
has exited the instrument. A "spring back" of 100 percent would
apply to a needle that returns to its original shape whereas a
needle having a "spring back" of 0 percent would maintain the shape
of the curved segment of the instrument after the needle has exited
the instrument. The present invention may use needles having a
degree of spring back of from 0 to 100 percent. In select
embodiments, wherein an inelastic material is used, the needle has
a spring back of from 0 to about 10 percent. In alternative
embodiments, wherein an elastic material is used, the needle has a
spring back of from about 90 to about 100 percent.
[0020] After the proximal end of the needle exits the instrument,
the needle may be propelled further along its radial path by the
force-supplying mechanism, such as a trocar. Additionally, the
distal portion of the mechanism may be formed to a radial shape by
the instrument in the same manner as the needle. Additionally, the
radial shapes of the needle and mechanism may also be coplanar.
Engagement of the mechanism with the needle after the needle passes
from the instrument may be facilitated by mating surfaces of the
mechanism and needle, shaped, for example, to prevent radial or
lateral displacement of the needle proximal and mechanism distal
surfaces. The mechanism may also be engaged with the needle in a
manner that connects the mechanism and needle together such that
the connection is capable of being broken after the needle has
exited the instrument.
[0021] The passage in the instrument within which the needle
travels, and the forming radius in the instrument distal tip, each
comprise open-sided channels allowing the suture carried by the
needle to travel unimpeded during its forming and insertion into
the tissue. As the force-supplying mechanism pushes the needle
further into the tissue, the suture is carried along by the needle
through the passage formed in the tissue to deliver the suture to
the tissue.
[0022] During use, the tissue to be sutured is constrained by
pressure applied through closure between the upper, moveable jaw of
the instrument and the distal portion of the instrument which acts
as a fixed jaw. The upper, movable jaw contains a shaped passageway
that allows the curved needle to pass therethrough during use.
After the force-supplying mechanism has been fully inserted into
the instrument and the needle has achieved maximum travel into the
tissue, the mechanism may be withdrawn from the instrument.
[0023] When suturing thin sections, the needle may be passed
completely through the tissue and may then be ready for retrieval
using the jaws of the punch or another instrument. In the case of
thick tissue, 70 percent or more of the needle may protrude from
the tissue after the force-supplying mechanism is fully inserted,
such that opening the upper jaw slightly and moving the instrument
in a proximal direction would cause the needle to wedge in the
upper jaw passage, permitting the needle to be withdrawn completely
from the tissue. Following this procedure, the needle may be
retrieved using the punch or another instrument.
[0024] Accordingly, in one embodiment, the present invention
provides suturing instrumentation for suturing tissue having a
malleable needle portion having a sharpened distal tip and
constructed and arranged to deliver a length of suture material to
the tissue; a handheld instrument having a passageway and having a
distal end terminating in a nonlinear portion having a first
radius; and a force-supplying structure for applying a force to the
needle portion, wherein the force-supplying structure includes a
distal end capable of pushing the malleable needle portion through
the nonlinear portion, such that when the distal end of the
handheld instrument is positioned proximate to the tissue to be
sutured and the malleable needle portion is pushed by the distal
end of the force-supplying structure through the nonlinear portion,
the needle portion is deformed, thereby causing the needle portion
to deliver the suture material to the tissue.
[0025] In another embodiment, the present invention provides
suturing instrumentation for suturing tissue having a malleable
needle portion having a sharpened distal tip and constructed and
arranged to deliver a length of suture material to the tissue; a
handheld instrument having a passageway and having a distal end
terminating in a nonlinear portion having a first radius; and a
force-supplying structure for applying a force to the needle
portion, wherein the force-supplying structure includes a distal
end capable of pushing the malleable needle portion through the
nonlinear portion, such that when the distal end of the handheld
instrument is positioned proximate to the tissue to be sutured and
the malleable needle portion is pushed by the distal end of the
force-supplying structure through the nonlinear portion, the needle
portion is deformed, thereby causing the needle portion to deliver
the suture material to the tissue; and a jaw pivotally coupled to
the distal end of the handheld instrument for holding tissue as the
needle portion and suture material enters into the tissue.
[0026] In yet another embodiment, the present invention provides a
suture needle adapted for use with a handheld instrument defining
an axis and having an off-axis distal end, the needle including a
length of material having a sharpened distal tip and constructed
and arranged to deliver a length of suture material; and the
material of the needle being malleable, such that when the needle
is pushed through the handheld instrument, it elastically deforms
in accordance with the off-axis distal end.
[0027] In still another embodiment, the present invention provides
a suturing system having a malleable needle portion having a
sharpened distal tip and constructed and arranged to deliver a
length of suture material; a handheld instrument having a
passageway and having a distal end terminating in a nonlinear
portion; and a push member configured for movement in the
passageway of the handheld instrument, the push member being
operative to push the malleable needle portion through the
nonlinear portion, such that when the distal end of the handheld
instrument is positioned proximate to a tissue to be sutured and
the needle portion is pushed by the push member through the
nonlinear portion, the needle portion is deformed and enters into
the tissue and delivers the suture material to the tissue being
sutured.
[0028] In yet another embodiment, the present invention provides a
method for suturing, including the steps of providing a malleable
needle portion having a sharpened distal tip; positioning the
needle in a passageway of a handheld instrument; providing a suture
material to be delivered by the needle portion; and using a push
member to push the needle portion in the handheld instrument, the
needle portion upon exiting the handheld instrument penetrating the
tissue being sutured and delivering the suture material to the
tissue being sutured.
[0029] In still another embodiment, the present invention provides
a system and method for suturing using a smaller suture wherein the
needle is designed such that the suture may be looped back directly
into the needle. As such, when the push member pushes the needle
portion into and/or through the tissue, the needle delivers a loop
of suture material that may then be used as an eyelet or other
mechanism for the transfer of other suture. Alternatively, a
smaller needle may be used during delivery of the suture to create
a loop of suture material in the tissue to be sutured.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] FIG. 1 is a plan view of a suture punch formed in accordance
with the principles of this invention;
[0031] FIG. 2 is a side view of the instrument of FIG. 1;
[0032] FIG. 3 is an end view of the instrument of FIG. 1;
[0033] FIG. 4 is an expanded view of the distal tip of the
instrument of FIG. 1;
[0034] FIG. 5 is a sectional view of the distal tip of FIG. 2 at
location A-A;
[0035] FIG. 6 is a sectional view of the distal tip of FIG. 2 at
location B-B;
[0036] FIG. 7 is a sectional view of the instrument at location
C-C;
[0037] FIG. 8 is a sectional view of the instrument at location
D-D;
[0038] FIG. 9 is a sectional view of the instrument at location E-E
with the trocar and needle removed;
[0039] FIG. 10 is an expanded view of the distal tip of the
instrument;
[0040] FIG. 11 is a plan view of a needle constructed in accordance
with the principles of this invention;
[0041] FIG. 12 is a side view of the needle of FIG. 5;
[0042] FIG. 13 is an end view of the needle of FIG. 5;
[0043] FIG. 14 is a plan view of the upper jaw of the
instrument;
[0044] FIG. 15 is a side view of the upper jaw of FIG. 14;
[0045] FIG. 16 is a sectional view of the upper jaw of FIG. 14;
[0046] FIG. 17 is an end view of the upper jaw of FIG. 14;
[0047] FIG. 18 is a trocar used in accordance with one embodiment
of this invention;
[0048] FIG. 19 is an expanded view of the distal end of the trocar
of FIG. 18;
[0049] FIG. 20 is an expanded sectional view of the proximal end of
the trocar of FIG. 18;
[0050] FIG. 21 is an expanded view of the distal portion of the
trocar of FIG. 19;
[0051] FIG. 22 is an end view of the trocar of FIG. 18;
[0052] FIG. 23 is a sectional view of the instrument of FIG. 1 with
trocar and needle in place;
[0053] FIG. 24 is an expanded view of the distal portion of FIG.
23;
[0054] FIG. 25 shows a needle and trocar loaded and the upper jaw
open in preparation for use;
[0055] FIG. 26 is an expanded view of the distal end of the
instrument of FIG. 25;
[0056] FIG. 27 depicts the instrument grasping tissue in
preparation for passing a needle with suture therethrough;
[0057] FIG. 28 is an expanded view of the distal end of the
instrument grasping tissue as shown in FIG. 27;
[0058] FIG. 29 shows the trocar now advanced so that the needle tip
is beginning to pierce tissue grasped between the instrument
jaws;
[0059] FIG. 30 is an expanded view of the distal end of the
instrument shown in FIG. 29;
[0060] FIG. 31 shows the trocar advanced so that the needle has
approximately 90 percent penetration of tissue grasped between the
instrument jaws;
[0061] FIG. 32 is an expanded view of the distal end of the
instrument shown in FIG. 31;
[0062] FIG. 33 shows the trocar advanced so that the needle has
passed through tissue grasped between the instrument jaws and
protrudes beyond the superior surface of the moveable jaw;
[0063] FIG. 34 is an expanded view of the distal end of the
instrument of FIG. 33;
[0064] FIG. 35 shows the trocar fully advanced so that the trocar
distal tip has forced the needle proximal end significantly through
the tissue grasped between the instrument jaws;
[0065] FIG. 36 is an expanded view of the distal end of the
instrument of FIG. 35;
[0066] FIG. 37 is similar to FIG. 35, but with the trocar retracted
so that only the needle and suture remain within the tissue;
[0067] FIG. 38 is an expanded view of the distal end of the device
of FIG. 37;
[0068] FIG. 39 is similar to FIG. 37, but with the moveable jaw
retracted;
[0069] FIG. 40 is an expanded view of the distal end of FIG.
39;
[0070] FIG. 41 is similar to FIG. 30, but with the distal end
retracted proximally from the tissue so that the needle is pulled
from the tissue by the moveable jaw;
[0071] FIG. 42 is an expanded view of the distal end of FIG.
41;
[0072] FIG. 43 is similar to FIG. 41, but with the needle grasped
between the jaws of the instrument;
[0073] FIG. 44 is an expanded view of the distal end of FIG.
43;
[0074] FIG. 45 is similar to FIG. 43, but with the needle rotated
and grasped between the jaws in preparation for withdrawal through
the cannula;
[0075] FIG. 46 is an expanded view of the distal end of FIG.
45;
[0076] FIG. 47 is a plan view of an alternate needle configuration
according to the invention;
[0077] FIG. 47a is a plan view of an alternate suture configuration
according to one embodiment of the invention;
[0078] FIG. 48 is a side view of the needle configuration of FIG.
47;
[0079] FIG. 49 is an end view of the needle configuration of FIG.
47;
[0080] FIG. 50 is a plan view of yet a further alternate needle
configuration according to the invention;
[0081] FIG. 51 is a side view of the alternate needle configuration
of FIG. 50;
[0082] FIG. 52 is an end view of the alternate needle configuration
of FIG. 50;
[0083] FIG. 53 is a plan view of an alternate top jaw configuration
according to the invention;
[0084] FIG. 54 is a side view of the alternate top jaw
configuration of FIG. 53;
[0085] FIG. 55 is an end view of the alternate top jaw
configuration of FIG. 53;
[0086] FIG. 56 is a sectional view of the alternate top jaw
configuration of FIG. 53;
[0087] FIG. 57 is a sectional view of upper and lower jaws with
jaws closed and needle fully extended;
[0088] FIG. 58 is a sectional view of upper and lower jaws with
jaws opened 50 percent and needle fully extended;
[0089] FIG. 59 is a sectional view of upper and lower jaws with
jaws opened 100 percent and needle fully extended;
[0090] FIG. 60 is a sectional view of upper and lower jaws with
jaws opened 100 percent and the suture being pulled through the
tissue;
[0091] FIG. 61 is a plan view of yet a different alternate needle
according to the invention;
[0092] FIG. 62 is a lateral side view of the different alternate
needle of FIG. 61;
[0093] FIG. 63 is an end-on view of the alternate needle of FIG. 61
viewed from the distal tip;
[0094] FIG. 64 is a plan view of an alternate construction of the
upper/moveable jaw;
[0095] FIG. 65 is a side view of the alternate construction of the
upper/moveable jaw of FIG. 64;
[0096] FIG. 66 is a bottom-side plan view of the alternate
construction of the upper/moveable jaw of FIG. 64;
[0097] FIG. 67 is an end view of the alternate construction of the
upper/moveable jaw of FIG. 64 from the proximal end;
[0098] FIG. 68 is an end view of the alternate construction of the
upper/moveable jaw of FIG. 64 from the distal tip;
[0099] FIG. 69 is a sectional view of the alternate construction of
the upper/moveable jaw of FIG. 64 in direction J-J;
[0100] FIG. 70 Is a sectional view of the alternate construction of
the upper/moveable jaw of FIG. 64 in direction K-K;
[0101] FIG. 71 is a sectional view of the alternate construction of
the upper/moveable jaw of FIG. 64 in direction L-L;
[0102] FIG. 72 is a sectional view of the upper jaw of FIG. 64
assembled to the lower jaw and with the needle of FIG. 61 deployed
in tissue and ready for retrieval;
[0103] FIG. 73 is a sectional view of the upper jaw of FIG. 64
assembled to the lower jaw and with the needle of FIG. 61 captured
in the upper jaw;
[0104] FIG. 74 is a sectional view of the upper jaw of FIG. 64
assembled to the lower jaw and with the needle of FIG. 61 captured
in the upper jaw and withdrawn from the tissue;
[0105] FIG. 75 is a sectional view of the upper jaw of FIG. 64
assembled to the lower jaw and with the needle of FIG. 61 captured
by the instrument and positioned for withdrawal through a
cannula;
[0106] FIG. 76 is an alternate needle having a radial shape and
made of Nitinol;
[0107] FIG. 77 is a plan view of the needle of FIG. 76 prior to
forming;
[0108] FIG. 78 is an end view of the needle of FIG. 76;
[0109] FIG. 79 is a plan view of an alternate needle according to
the invention;
[0110] FIG. 80 is a side view of the needle of FIG. 79;
[0111] FIG. 81 is an end view of the needle of FIG. 79;
[0112] FIG. 82 is a plan view of an alternate top jaw according to
the invention;
[0113] FIG. 83 is a side view of the alternate top jaw of FIG.
82;
[0114] FIG. 84 is a side sectional view of the alternate top jaw of
FIG. 82;
[0115] FIG. 85 is an end view of the alternate top jaw of FIG.
82;
[0116] FIG. 86 is an expanded lateral sectional view of the
alternate top jaw of FIG. 82;
[0117] FIG. 87 is a drawing of a jawless suture punch according to
the present invention;
[0118] FIG. 88 is a drawing of a trocar pusher adapted for use with
the jawless punch of FIG. 87;
[0119] FIG. 89 is a drawing of the distal tip of an angled jaw or
jaw-less design according to the present invention;
[0120] FIG. 90 is a drawing of a particularized capsular plication
suture punch for the shoulder according to the present
invention;
[0121] FIG. 91 is a simplified drawing which shows the way in which
three rigidly positioned points may be used to curve a needle into
a selected radius according to the present invention;
[0122] FIG. 92 is a drawing depicted in partial transparent form,
illustrating a more sophisticated jawless punch according to the
present invention;
[0123] FIG. 93 is an oblique view of the device of FIG. 92;
[0124] FIG. 94 is a close-up view of the distal end including the
curved tip;
[0125] FIG. 95 is a side-view of the device of FIG. 93 with the
needle loaded in position;
[0126] FIG. 96 is a perspective-view of the configuration shown in
FIG. 95;
[0127] FIG. 97 is a side-view showing the trocar being advanced by
pushing on the proximal end of the pusher rods;
[0128] FIG. 98 shows the needle being pushed passed the breached
loading position, with the suture material extending out from a
slot;
[0129] FIG. 99 shows the needle being deformed and pushed out the
distal end;
[0130] FIG. 100 shows the needle fully advanced, now free of the
distal tip of the instrument;
[0131] FIG. 101 is a close-up, detail view of the needle emerging
from the curved distal tip of the instrument;
[0132] FIG. 102A shows the jaws open ready to grab the tip of the
needle;
[0133] FIG. 102B shows the needle grasped;
[0134] FIG. 102C shows how, even once grasped, the tip of the
needle may rotate within the jaws;
[0135] FIGS. 103A-103C are side views of the embodiments of FIGS.
102A-102C;
[0136] FIG. 104 is a perspective view of the grasping mechanism in
conjunction with the tip of the needle;
[0137] FIG. 105A is a first view of a needle according to the
invention particularly suited to certain shoulder procedures;
[0138] FIG. 105B is a different view of the needle of FIG.
105A;
[0139] FIG. 105C is a end-on view of the needle of the FIGS. 105A
and 105B;
[0140] FIG. 106 is a retrieval instrument associated with the
needle of FIG. 105;
[0141] FIG. 107A is a close-up view drawing of the retrieval tip of
the instrument of FIG. 106;
[0142] FIG. 107B is a different view of the retrieval tip;
[0143] FIG. 107C is an end-on view of the retrieval tip;
[0144] FIG. 108 shows a distal portion of an insertion instrument;
and
[0145] FIG. 109A through 109K show the way in which the needle of
FIG. 105, insertion of FIG. 108 and retrieval instrument of FIGS.
106 and 109 are used.
DETAILED DESCRIPTION OF THE INVENTION
[0146] The present invention is more particularly described in the
following examples that are intended to be illustrative only since
numerous modifications and variations therein will be apparent to
those skilled in the art. As used in the specification and in the
claims, the singular form "a," "an," and "the" may include plural
referents unless the context clearly dictates otherwise. Also, as
used in the specification and in the claims, the term "comprising"
may include the embodiments "consisting of" and "consisting
essentially of."
[0147] The present invention will now be further described through
the following drawings. It is to be understood that these drawings
are non-limiting and are presented to provide a better
understanding of various embodiments of the present invention and
are not intended to represent every possible embodiment of the
present invention.
[0148] Referring to the drawings, as best seen in FIGS. 1 through
9, the instrument body 11 has a proximal end 1 and a distal end 2.
The distal end further includes a fixed portion (or fixed jaw) 3
and a movable portion (or moveable jaw) 4. The movable portion 4 is
rotatable about pin 5 passing through the movable portion 4 and
fixed portion 3 thereby forming a hinge.
[0149] The position of movable jaw 4 is determined by positioning
rod 6 which transmits an opening or closing force to movable
portion 4 via hinge pin 7. The position of positioning rod 6 is
determined by the position of movable handle 8, which is connected
to the proximal end of positioning rod 6 through pin 9. The
positioning rod 6 passes through elongated section 18 of instrument
body 11 and through passage 17.
[0150] Movable handle 8 is rotatably affixed to the instrument body
11 by pin 10 so that rotating movable handle 8 counterclockwise
opens movable jaw 4 and rotating movable handle 8 clockwise closes
movable jaw 4 with a closure force proportional to that applied
between movable handle 8 and fixed handle 12. Closure pressure
between the jaws may be maintained by a ratcheting action created
through the interraction between tooth section 13 of movable handle
8 and serrations 14 on arcuate section 15 of fixed handle 12.
[0151] Closure pressure may be released by elastically deforming
arcuate section 15 upward with pressure applied to proximal end 16
of the arcuate section. Fixed jaw 3 and movable jaw 4 may include
serrations 8 formed on their angularly transposed surfaces to
facilitate the grasping of tissue placed between them. Removable
trocar 70 protrudes from the proximal end of instrument body
11.
[0152] As is best seen in FIGS. 11 through 13, one embodiment of
the needle 20 has a proximal end 21 and a distal end 22, and a
rectangular cross-section 27 with upper surface 28, lower surface
29 and lateral surfaces 30. The proximal end 21 includes a
contoured proximal surface 23, conical in shape in one embodiment,
and having a conical angle 24 and a conical axis 25 coaxial with
needle centerline 26. The distal end 22 is shaped to form a cutting
edge 28 having included angle 27. Suture 31 is connected to a
needle lateral surface 30 at a distance 32 from the needle proximal
end.
[0153] As is best seen in FIGS. 4, 5, 9, and 10, the instrument
body 11 has a continuous passage 40 of varying cross-section
extending from the proximal-most face 41 of instrument body 11 to
the upper surface 42 of fixed jaw 3 near the jaw's distal tip. In
section 43, extending a distance 44 from proximal face 41, the
passage has a cylindrical cross-section of a specified diameter 56
as shown in FIGS. 7 and 8. In section 45, extending a distance 46
from the distal end of section 43, the passage is a rectangular
channel 44, the height of the channel 51 being slightly greater
than the thickness 45 of needle 20. Distance 46 is sufficiently
longer than the length of needle 20 to allow easy placement of the
needle in the slot.
[0154] Section 47 of the slot extends from the distal end of
section 45 to the termination of the slot at the top surface 42 of
fixed jaw 3 and beneficially includes of a linear portion 48 and a
radial portion 49 having a known radius 50. As is best seen in FIG.
5, the cross-section of channel 40 in section 47 is rectangular
having a height 51 slightly greater than the thickness 45 of needle
20 and a width 52 slightly greater than width 53 of needle 20. A
slot 54 having a height 55 less than height 51 of passage 40
extends through the entirety of section 47.
[0155] As is best seen in FIGS. 14 through 17, upper jaw 4 contains
a shaped passageway 60 having a width 61 slightly larger than width
52 of passage 40 and extending from the jaw's lower surface 63 to
upper surface 64. As best seen in FIGS. 4 and 10, upper jaw 4
protrudes distally a distance 62 beyond lower jaw 3.
[0156] Referring to FIGS. 18 through 22, the force-supplying
mechanism is a trocar 70 that is an assembly including a stepped
cylindrical rod 71 and hub 72 and having a distal end 73 and
proximal end 74, with the hub being attached to proximal end 74.
Stepped metallic cylindrical rod 71 features a larger diameter
section 75 of specified length 76 and diameter 77, with the
diameter being slightly smaller than diameter 56 of section 43 of
passage 40 so allowing trocar 70 may move freely within instrument
body 11 when inserted into passage 40. Cylindrical rod 71 has a
smaller diameter section 78 of specified length 79 and diameter 80,
with the diameter being slightly smaller than height 51 of sections
45 and 47 of passage 40 allowing trocar 70 to move freely within
elongated section 18 of instrument body 11 when inserted into
passage 40. Rod 71 is hardened throughout its length to prevent
bending, except section 81 extending a length 82 from distal tip 73
is annealed for high malleability. Distal tip 73 is formed to a
conical shape of conical angle 83, with the conical angle being
equal to conical angle 24 on proximal end 21 of needle 20.
[0157] Referring to FIGS. 23 and 24, when prepared for use, needle
20 is inserted laterally into section 45 of passage 40 with the
lateral surface 30 with suture 31 facing the open side of channel
40 and suture 31 extending from elongated section 18 of body 11.
After insertion, needle 20 is moved distally to section 47 of
channel 40; trocar 70 is inserted into channel 40 of instrument
body 11, and positioned as shown in FIGS. 23 and 24.
[0158] Referring to FIGS. 25 and 26, when using the instrument to
pass a suture the movable jaw 4 is opened using movable handle 8.
Trocar 70 is inserted into instrument body 11 until trocar distal
end 73 engages needle proximal end 21. Suture 31 carried by the
needle 20 moves freely in slot 54.
[0159] During use of the device, as seen best in FIGS. 27 and 28,
tissue is grasped between upper jaw 4 and lower jaw 3. Referring to
FIGS. 29 and 30, advancing trocar 70 a distance 85 distally causes
needle 20 to move distally in channel 20, the distal portion of the
needle being formed to a radius 50 by the radial portion 49 of
passage 40.
[0160] Referring to FIGS. 31 and 32, advancing the trocar an
additional distance 86 causes needle 20 to be formed to a radial
shape of radius 87, radius 87 being larger than radius 50 of
section 49 of passage 40 due to spring back of the needle after
leaving the passage radial section 49. Needle 20 follows a radial
path through the tissue. Advancing trocar 70 an additional distance
88 (see FIGS. 33 and 34) causes needle 20 to advance along its
radial path until needle distal tip protrudes above top surface 64
of movable jaw 4, having passed through jaw 4 via passage 60.
[0161] As is best seen in FIGS. 35 and 36, advancing trocar 70
distally until hub 72 contacts distal face 41 of instrument body 11
advances needle 20 further through the tissue, with distal tip 73
of trocar 70 assuming a radial shape of radius 87 as it passes
through radial portion 49 of passage 40. Alignment between trocar
distal tip 73 and needle proximal end 21 is maintained by
engagement of the needle proximal end conical recess with the with
the trocar distal tip conical protrusion, needle proximal end
conical radius 24 and trocar distal tip conical radius 83 being
equal. In this manner, needle 20 and suture 31 are advanced a
distance 89 into the tissue beyond the top surface of lower jaw
3.
[0162] As is best seen in FIGS. 37 and 38, withdrawing trocar 70 a
distance 90 causes the trocar distal tip 73 to be withdrawn from
the tissue into the distal portion of passage 40, leaving needle 20
and suture 31 in the tissue, with needle distal tip 22 protruding
well above the top surface of upper jaw 3. As seen in FIGS. 39 and
40, upper jaw 3 is now retracted with needle 20 moving freely
within passage 60. Referring now to FIGS. 41 and 42, withdrawing
the instrument axially causes needle 20 in slot 60 of upper jaw 3
to be pulled free from the tissue with suture 31 now passing
through the tissue. Referring to FIGS. 43 and 44, closing jaw 3
causes it to grasp needle 20 thereby allowing further retraction of
the needle and the suture. As seen in FIGS. 45 and 46, jaws 3 and 4
may be opened thereby freeing needle 20, and the needle rotated 90
degrees and re-grasped by jaws 3 and 4.
[0163] Although the above description references "needle 20,"
various other needle designs are equally applicable to the
invention. In another embodiment, shown in FIGS. 47 through 49,
needle 92 has a cross-section with two parallel sides, the lateral
faces having a nearly radial profile, a shape producible by coining
a cylindrical needle. Additionally, prior to delivery of the suture
material, the suture material may be a standard suture or may be a
smaller suture. As shown in FIG. 47a, the suture material may be
looped back into the needle 92 such that when the needle 92 is
delivered to the tissue, a loop of suture material is delivered
that may then be used for other purposes, such as an eyelet for the
transfer of other sutures.
[0164] In another embodiment, shown in FIGS. 50 through 52, needle
94 has a non-uniform cross-section, upper and lower surfaces 95 and
96 having a plurality of angled surface segments 98 of angle 95
each surface terminating in a radius 96 so as to form a series of
notches useful in engaging corners of passage 60 in upper jaw 3 so
as to aid in needle retraction during axial withdrawal of the
instrument.
[0165] In addition to alternative needle designs, jaw construction
is likewise variable in accordance with the invention. In another
embodiment, best seen in FIGS. 53 through 56, upper jaw 100 is of
similar construction to upper jaw 3 except that passage 60 has been
replaced with slot 101. As is best seen in FIGS. 57 through 59, the
distal protrusion 62 of upper jaw 4 beyond lower jaw 3 is required
to allow needle 20 to enter passage 60 throughout the range of
positions of upper jaw 4. FIG. 60 is a sectional view of upper and
lower jaws with jaws opened 100 percent and the suture being pulled
through the tissue.
[0166] A further alternate needle 201 is shown in FIGS. 61 through
63. As is best seen in FIG. 62, the needle of thickness 220 has a
distal end 202 and a proximal end 203, with the distal end formed
to a wedge shape having included angle 204 so as to form a cutting
edge 205. The proximal end 203 has a conical shape 206 formed
therein and having an angle 207 equal to angle 83 on the distal tip
of trocar 70 shown in FIGS. 18 through 22. As is best seen in plan
view FIG. 61, needle 201 has three sections distinguished by their
width. Proximal section 208 and distal section 209 have a width
210, while medial section 211 has a width of 212 than width 211.
Distal section 209 is not of constant width, but rather tapers to a
width 213 at its distal tip. The transition from middle section 211
to proximal section 208 is a taper of length 214 and angle 215.
Suture 216 is connected to lateral surface 217 of proximal section
208 a distance 218 from proximal end 203.
[0167] An alternate upper jaw to be used in conjunction with
alternate needle 201 is shown in FIGS. 64 through 71. As is best
seen in FIGS. 64, 66 and 68, upper jaw 110 is constructed like
upper jaw 4 having a distal end 111 and a proximal end 112, except
that upper jaw 110 has a distal end slot 113, the distal slot
having a proximal portion 114 and a distal portion 120, and the
portions being distinguished by their width. Proximal portion 114
has a length 125 and a width 115 which is slightly larger than
width 210 of proximal section 208 and distal section 209 of needle
201 as shown in FIG. 61. Distal portion 120 has a width of 121
which is slightly larger than width 212 of middle section 211 of
needle 201 shown in FIG. 61.
[0168] As is best seen when viewing jaw 110 laterally as in FIG.
65, distal portion 111 of jaw 110 has a hooked portion 126 formed
therein, the hooked portion having a radius 127 and a height 128,
height 128 being somewhat larger than thickness 220 of needle 201
as seen in FIG. 62. As is best seen in axial sectional view FIG.
71, proximal portion 114 of slot 113 has a portion 130 of height
131 with parallel sides and a portion 132 of height 133 whose
lateral facing sides are angled outward at angle 134 so that the
bottom of the slot is wider than the top of the slot.
[0169] The functioning of alternate needle 201 and alternate jaw
110 is best seen in FIG. 72 through 75. Functioning of the needle
and jaw are as explained previously except, referring to FIG. 72,
needle 201 being of a shorter length than that of needle 20 and
trocar 170 being of a shorter length than trocar 70, when trocar 70
is fully inserted to the limit of its travel, the portion of needle
201 remaining within tissue 171 is greater than that remaining in
the previously explained embodiments. The length 175 of the portion
of needle 201 protruding beyond tissue 171 is sufficient to cause
the distal end of medial portion 211 of needle 201 to extend above
surface 172, needle 201 having passed through proximal portion 114
of slot 113, and, as shown in FIG. 72 passed into distal portion
120 of slot 113 due to movement of the instrument proximally.
[0170] In this embodiment, needle 201 is prevented from
disengagement from the distal portion 120 of slot 113 because the
width 210 of needle distal portion 209 is greater than width 121 of
slot distal portion 120. Needle 201 is able to move freely within
slot 113 parallel to the axis of the slot as width 212 of needle
medial portion 211 is less than width 121 of distal portion 209 of
slot 113. Referring to FIG. 73, withdrawing the instrument
proximally causes needle 201 to move distally and pivot within
distal portion 120 of slot 113 so as to engage with the hook
segment 126 of jaw 110, thereby allowing needle 201 to be extracted
from tissue 171, causing suture 216 to be pulled through the
tissue. As is best seen in FIG. 74, after needle 201 is free of
tissue 171 upper jaw 110 may be closed and additional suture pulled
through the tissue. As seen in FIG. 75, jaw 110 may be closed
totally thereby allowing needle 201 and suture 216 to be withdrawn
through a cannula.
[0171] An alternate needle made of Nitinol and formed to a radial
shape during manufacture is shown in FIGS. 76 through 78.
Manufacture of needle 400 is accomplished in two steps, namely the
cutting of the needle blank profile 401 from sheet material, and
forming of the needle to a shape having radius 402, with radius 402
being equal to forming radius 50 of lower jaw 3 as shown in FIG.
10. Needle 400 may be used in the same manner as previous
embodiments as it will be constrained in a straightened state by
channel 47 (FIG. 9) prior to deployment. Needle capture and
retrieval are accomplished in the same manner as needle 201
described previously and shown in FIGS. 72 through 75. Conversely,
a Nitinol needle may be used having a linear shape, which is
constrained into the radial shape as the needle passes through the
radius of the lower jaw 3. Additionally, in other embodiments, a
smaller Nitinol needle, i.e. having a smaller diameter, may be used
for creating a looped suture in the tissue wherein the smaller
needle creates a loop in the suture material as it is delivered due
to the reduced diameter of the needle.
[0172] An alternate needle 500 having multiple "barbs" displaced
along its lateral surfaces is shown in FIGS. 79 through 81. The
needle features a distal end 501 shaped to a cutting edge 506
having included angle 507, and a proximal end 502 having a convex
conical shape 503 with conical angle 504. The conical angle is, in
one embodiment, equal to distal tip angle 83 of trocar 70, shown in
FIG. 21. Suture 508 is attached to a lateral face 510 a distance
511 from distal end 502. Needle 500 has a width 507 and a number of
pyramid-shaped "barbs" 512 displaced along lateral surfaces 510,
the lateral distance 513 between barb tips being greater than width
507. The barb protrusions are pyramidal in shape having a length
514, width 515 and height 516, the distal edge 517 forming an angle
518 with the lateral surface 510.
[0173] FIGS. 82 through 86 show an alternate upper jaw for use with
needle 500. Jaw 600 in constructed in the manner of jaw 4, except
that jaw 600 includes a hollow structure of wall thickness 602
forming a capture space 601. The capture space 601 is defined by
the walls of the jaw and by the inner surface 603 of the jaw lower
wall 604. Jaw lower wall 604 has a slot 605 of width 606, width 606
being greater than width 507 of needle 500, but less than distance
513 between barb tips of needle 500. The lower section of slot 605
is tapered outward so as to aid needle 500 in entering slot
605.
[0174] Needle 500 and upper jaw 600 are used in the same manner as
needle and jaw configurations previously disclosed; that is, needle
500 is formed to a radial shape by the instrument, passes through
tissue confined by pressure from the upper and lower jaws, and
enters the upper jaw where it is captured for retrieval. Needle 500
and jaw 600 vary in the method of capture. Distal tip 501 of needle
500 enters slot 605 of jaw 600, and via the slot enters space 601.
Slot 605, being less in width than distance 513 between the needle
barb tips, causes the barb tips to deform as they pass into space
601 via slot 605. Also, because wall thickness 602 is rather thin,
jaw 600 will spread slightly so as to allow the barbs to pass.
Because the barb proximal surfaces are square rather than tapered,
the needle is retained in the slot.
[0175] The embodiments described thus far included a pair of jaws,
beneficially a fixed jaw and movable jaw, with the later being
additionally responsible for any capture of a needle having been
radially deformed and passed through tissue. Although the invention
has been described in terms of a fixed jaw and a movable jaw, it
will be apparent to those of skill in the art of mechanical design
that versions of the invention wherein both jaws move are also
anticipated, assuming appropriate interaction associated with
needle curvature and any capture of the needle.
[0176] In addition, there are situations, and embodiments of this
invention, where capture is performed not by a jaw coupled to the
same instrument, but rather, through the use of an additional
instrument. Reference to FIGS. 87-91, which illustrate a simpler
suture punch according to the invention, which is similar to the
embodiments described above, but does not include an upper jaw to
hold tissue and/or retain a needle once formed. Nevertheless, the
same type of malleable needle according to the invention having a
suture/suture loop is inserted into these simpler devices, and
pushed down the channel by a pusher, which acts as the
force-supplying mechanism. Since the terminal action of the needle
is the same as that used with the more sophisticated device as
described herein, the shaft of the channel must be stiff enough to
resist a perpendicular vector force required to push the needle
through the tissue. One advantage of these alternative designs is
that such instruments may be used to plicate the shoulder capsule
from the inside arthroscopically. FIG. 87 is a drawing of a jawless
suture punch according to the invention, including a curved distal
end 802, and a proximal end 804 including an insertion point 806.
FIG. 88 is a drawing of a pusher adapted for use with the jawless
punch of FIG. 87. The pusher includes a sharpened malleable/spring
steel tip 812 coupled to a blunt 814 through an eyelet 816 to
receive a thread or suture loop. In operation, the curved tip 802
is placed next to tissue to be sutured, and the sharp tip inserted
into the insertion point 806. The sharp tip is then advanced with
the pusher of FIG. 88 through the tissue, allowing the suture to be
pulled through the tissue as well.
[0177] FIG. 89 is a drawing of a lower jaw of a suture punch or a
jaw-less design according to the invention. According to this
embodiment, a malleable needle is inserted into a loading slot 820
such that the tip of the needle is proximate to the distal end by a
distance of 1/8 inch, or thereabouts. The instrument is inserted
through cannula, upon which time the tissue is grasped and a
flexible trocar is pushed down trocar channel 822. As the flexible
tip of the trocar nears the needle slot 820, the bend in the
channel directs the tip down the needle slot, engaging the proximal
end of the needle. As the trocar is advanced further, the needle is
pushed through the forming section of the lower jaw, resulting in a
deformation similar if not identical to the other embodiments
described herein. FIG. 90 is a drawing of a particularized capsular
plication suture punch for the shoulder according to the invention.
Distance d indicates the portion of the capsule to be plicated,
with the capsule surface being shown at 902. A malleable needle is
inserted into the proximal end of the device, which penetrates into
and out of the capsule, with the entire instrument remaining on one
side of the surface 902. The depth of the penetration may be
controlled for the curvature of the insertion channel, and the
malleability characteristics of the needle. FIG. 91 is a simplified
drawing which shows the way in which three rigidly positioned
points may be used to curve a needle into a selected radius
according to the invention. Once the needle and suture passes
through the capsule, a separate needle capture mechanism 910 may be
used to pull the suture through, as described elsewhere herein.
[0178] FIG. 92 is a drawing depicted in partial transparent form,
illustrating a more sophisticated jawless punch according to one
embodiment of the invention, including yet a further alternative
needle including a distal tip configured for grasping with a
separate instrument. The instrument depicted generally at 920
includes a body portion having a squeeze handle 922 coupled to a
ratchet 924 which engages with barbs 926 on a pusher mechanism. The
pusher mechanism extends through the barrel of the instrument down
to the distal tip 930, which terminates in a curved portion 932,
and includes a breach loading slot 934 to receive a needle 940
attached to suture 941 and including a distal tip 942 configured
for grasping. FIG. 93 is an oblique drawing of the device of FIG.
92. FIG. 94 is a close-up view drawing of the distal end 930
including curved tip 932, breach loading slot 934 and specialized
needle 940 having a tip 942 configured for manual grasping, the
needle 940 being attached at its proximal end to suture material
941. FIG. 95 is a side-view drawing of the device of FIG. 93 with
the needle loaded in position; FIG. 96 is a perspective-view
drawing of the configuration shown in FIG. 95. FIG. 97 is a
side-view drawing showing the trocar being advanced by pushing on
the proximal end of the pusher rods. FIG. 98 is a detail drawing
showing the needle being pushed passed the breached loading
position, with the suture material extending out from a slot, and
with the needle in position just prior to deformation. FIG. 99 is a
drawing which shows the needle being deformed and pushed out the
distal end, as handle 922 is compressed, causing the ratchet 924 to
advance the barbs 926 on the pusher rod. FIG. 100 is a drawing
which shows the needle fully advanced, now free of the distal tip
of the instrument. FIG. 101 is a close-up, detail view of the
needle emerging from the curved distal tip of the instrument.
[0179] As discussed above, with respect to the jawless embodiments
of this invention, a separate instrument would generally be used to
grasp the formed needle, having passed through tissue to be
sutured. While conventionally available tools such as forceps, and
the like, may be used for such purpose, particularly with respect
to the specialized needle shown in FIG. 94 and elsewhere herein,
specialized needle grasping instruments may be provided, as shown
in FIGS. 102-104. FIG. 103A is a drawing which shows a grasping
mechanism 1002 having a specially shaped set of jaws to capture the
tip of certain needles described herein. In particular, the
embodiments of FIGS. 102-104 are specially suited to grasp the tip
of the needle best seen in FIG. 94. FIG. 102A shows the jaws open
ready to grab the tip of the needle. FIG. 102B shows the needle
grasped, and FIG. 102C shows how, even once grasped, the tip of the
needle may rotate within the jaws. FIGS. 103A-103C are side views
of the embodiments of FIG. 102A-102C, and FIG. 104 is a perspective
view of the grasping mechanism in conjunction with the tip of the
needle.
[0180] Yet a further embodiment, intended for applications such as
the repair of tom meniscus, torn labrum, capsular reefing to the
labrum and other applications, is described in the following text
and FIGS. 105 through 109. This embodiment is different from the
previous embodiments in that the distal end of the insertion
instrument is configured so that the needle exits the instrument in
a direction that is axial to the instrument, wherein a normal to
the distal-most surface is parallel to the axis of the instrument.
The needle is formed to a somewhat larger radius so that when it is
fully inserted the needle tip protrudes from the upper (or lower)
surface of the tissue undergoing repair, the needle being formed,
in one embodiment, less than 90 degrees. When the needle is fully
inserted, the insertion instrument is removed leaving the needle
and suture embedded in the tissue with its distal tip exposed.
[0181] The retrieval instrument distal end is somewhat like the
upper jaw of certain previous embodiments in that it has a hook
shape designed to allow the captured needle to pivot freely in the
plane in which it is formed. A feature allows the tool to exert a
force on a needle tip in the distal as well as the proximal
direction. The retrieval instrument distal end is also slotted, the
slot having a width slightly greater than that of the reduced width
region of the needle, but less than the width of the needle distal
tip.
[0182] In use, the wedge shaped distal end of the instrument is
inserted so that the reduced region of the needle is engaged by the
slot in the instrument. Moving the instrument distally causes the
needle to be pulled further through the tissue. When the head is
fully engaged in the slot the needle is pulled the rest of the way
through the tissue by moving the instrument distally a distance
sufficient to free the needle from the tissue and expose a short
length of suture. The retrieval instrument is then moved proximally
with the needle pivoting in the distal hook so that it may be
withdrawn through the cannula. After the needle is freed from the
tissue, the retrieval instrument may be rotated about its axis so
that the needle pivots in a plane in which there is sufficient
space for this to occur.
[0183] Referring to the drawings, as best seen in FIGS. 105A
through 105C, needle 2001 of width W.sub.1 (2004) and height
H.sub.1 (2005) has a distal end 2002 and a proximal end 2003. A
middle region 2009 having a width W.sub.2 (2006) forms "shoulders"
2012 at its distal end 2002 which is sharpened. A suture 2007 is
attached to lateral surface 2008 a distance L.sub.1 (2010) from
distal-most surface 2011.
[0184] Referring to FIG. 106, retrieval instrument 2020 has a
proximal portion 2021 formed to a handle shape and an elongated
distal portion 2022 terminating in distal tip 2023. Referring to
FIGS. 107A through 107C, distal tip 2023 has a slot 2024 of width
W.sub.3 (2025) which is slightly larger than width W.sub.2 (2006 in
FIG. 105A) but less than W.sub.1 (2004). The profile of distal end
2023 has a distal surface 2026 inclined at an angle A.sub.1 (2027)
and a capture region 2028 bounded on its distal end by hook-shaped
surface 2029 and on its proximal end by lateral surface 2030
displaced from surface 2029 a distance L.sub.2 (2031) and surface
2032.
[0185] FIG. 108 shows the distal portion 2040 of an insertion
instrument of this embodiment. Needle 2001 is positioned in the
forming channel 2047 and suture 2007 is affixed to the needle.
Distal portion 2040 has two radii, R.sub.1 (2041) and R.sub.2
(2042) which together displace forming channel 2045 a distance
D.sub.1 (2046). Radius R.sub.2 (2042) forms the needle to a radial
shape having a radius R.sub.3 (2049 in FIG. 109C) slightly larger
than R.sub.2 (2042). A normal to distal-most surface 2048 is
coaxial with the axis of the axis of portion 2040.
[0186] Referring to FIG. 109A, tissue 43 is to be sutured to tissue
2044. In FIG. 109B, the "tear" is closed by applying force to
tissue 2043 using distal portion 2040. In FIG. 109C, needle 2001
has been inserted in the same manner as in the previous embodiment.
In FIG. 109D, the insertion instrument has been removed and needle
2001 remains in place with suture 2007. In FIG. 109E, retrieval
instrument 2020 has been brought into position. FIG. 109F, distal
tip 2023 has been inserted such that needle 2001 is engaged in slot
2024 and surface 2026 (see FIG. 107B) acting on shoulders 2012
(FIG. 105A) of needle 2001 has displaced the needle distally in
tissue 2043 and 2044.
[0187] Referring to FIG. 109G, distal end 2002 of needle 2001 is
captured in region 20028 (FIG. 107B). Displacing retrieval
instrument 2020 distally (FIG. 109H) causes needle 2001 to be
extracted from tissue 2043 thereby pulling suture 2007 through the
tissue. In FIG. 109I additional suture has been pulled through the
tissue. In FIG. 109J, retrieval instrument 2020 has been moved
proximally causing needle 2001 to pivot in distal tip 2023. In FIG.
109K, needle 2001 has pivoted into position for retrieval through a
cannula.
[0188] Although the illustrative embodiments of the present
disclosure have been described herein with reference to the
accompanying drawings and examples, it is to be understood that the
disclosure is not limited to those precise embodiments, and various
other changes and modifications may be affected therein by one
skilled in the art without departing from the scope of spirit of
the disclosure. All such changes and modifications are intended to
be included within the scope of the disclosure as defined by the
appended claims.
* * * * *